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"If you spend all day sitting on your rear end then you might want to schedule some time for a brisk walk just make sure you can spare at least an hour. Scientists analyzing data from more than million people found that it takes about to minutes of moderate intensity exercise to undo the damage of sitting for at least eight hours a day. Not exercising and sitting all day is as dangerous as being obese or smoking they found. And the added risk of parking yourself in front of a television for hours or more a day after sitting at the office is so high even the hour of exercise is not enough to reverse the damage. We cannot stress enough the importance of getting exercise whether its getting out for a walk at lunchtime going for a run in the morning or cycling to work said Ulf Ekelund of the Norwegian School of Sports Sciences in Norway one of the study authors in a statement. It has been long suspected that sitting a lot at work or at home is not healthy. Previous studies have found that prolonged sitting can raise the chances of heart disease various cancers and an earlier death. In the new research experts combed through papers with data on factors including how long people spend sitting their physical activity levels and their televisionwatching habits. The majority of studies included people older than age . All except one were done in the U.S. Western Europe and Australia. Researchers found that people with the highest levels of moderate physical activity to minutes daily erased the higher risk of death linked to being seated for more than eight hours a day. But even that exercise regime was not enough to counter the hazards of also watching more than five hours of television a day. The paper was published online Wednesday in the journal Lancet. Lars Bo Andersen who coauthored an accompanying commentary called the new research very convincing explaining that too much sitting increases the risk of problems including diabetes and heart disease because it can make insulin levels spike and might slow the bodys metabolism. Andersen said that watching lots of television was probably even worse than sitting at the office all day because it likely includes other unhealthy habits. A lot of people dont just watch TV they eat fatty snacks at the same time said Andersen of Sogn and Fjordane University College in Norway. Andersen said that some cultures make it easier than others to squeeze in an hour of exercise every day noting that in Denmark and much of Scandinavia about half of all people either cycle or walk to work. But he said that getting the recommended amount of physical activity shouldnt be overly arduous and doesnt necessarily mean going to the gym for an intense workout. If you are walking and can feel yourself getting a little warm and your breathing is a little heavier thats enough he said. You dont have to be sweaty and out of breath to get the benefits. Copyright The Associated Press http All rights reserved. This material may not be published broadcast rewritten or redistributed."

"Elekta EKTAB.ST today announced new data demonstrating stereotactic body radiation therapy SBRT is a safe treatment option for earlystage lung cancer patients aged or older. The results which were based on data from more than patients across five institutions that comprise the Elekta Lung Research Group are available online and will be published in the July print issue of International Journal of Radiation Oncology Biology Physics http The study evaluated safety and efficacy outcomes of patient reports collected in a multiinstitutional database. Patients were treated with SBRT for earlystage lung cancer between and and followed for a median of . years. The cohort included patients under years of age patients ages to years and patients aged years or more which included patients aged years or more. The median age was years range to . Study results show no significant differences among the three age groups with respect to year local recurrence regional recurrence distant metastases or the incidence of grade or higher toxicity. Causespecific survival was similar among all three age groups . to . percent. Twoyear overall survival was lower in older patients which is likely related to other medical issues. Older patients are often not considered for radiation therapy due to concerns about their ability to tolerate treatment. The results of our study clearly support the use of SBRT for elderly patients especially those who may not be able to tolerate longer courses of radiotherapy or more invasive treatment options says Meredith Giuliani MBBS FRCPC MEd a radiation oncologist in the Cancer Clinical Research Unit at Princess Margaret Cancer Centre University Health Network in Toronto and lead study author. Radiation oncologists need to work closely with our peers in other parts of the medical community to ensure that patients with diagnosed or suspected earlylung cancer are evaluated for potential treatment with SBRT regardless of age. This study is the largest series of its type to evaluate SBRT outcomes in patients aged years and older says Joel Goldwein MD Senior Vice President Medical Affairs for Elekta. In addition to providing important support for using SBRT to treat earlystage lung cancer in elderly patients these findings highlight the value of multiinstitutional collaborations and large data sets that can provide statistically meaningful answers to critical questions about treatment outcome and guide clinical decision making. The Elekta Lung Research Group ELRG is an international collaboration of physicians and physicists that is evaluating clinical outcomes in earlystage nonsmall cell lung cancer patients. To date they have accumulated data on close to such patients and identified medical and technical factors that affect tumor control and toxicity. Their collective experience is among the largest multinational series of patients treated with imageguided SBRT to date. The ELRG includes participants from William Beaumont Hospital in Royal Oak Michigan Princess Margaret Cancer Centre Thomas Jefferson University in Philadelphia Pennsylvania JuliusMaximilians University of Wrzburg in Wrzburg Germany and The Netherlands Cancer InstituteAntoni van Leeuwenhoek hospital in Amsterdam The Netherlands. Disclosure This research was partially supported by Elekta through a research grant with all institutions being members of the Elekta Lung Research Group. This work and these data however are the intellectual property of the individual group members and their sponsoring institutions. The authors declare no other conflicts of interest. The following files are available for download httpmb.cision.comMain.pdfPDF SOURCE Elekta"

"A new study finds that a noninvasive electromagnetic brain stimulation technique helps obese people lose weight partly by changing the composition of their intestinal bacteriathe socalled gut microbiota. Results of the technique called deep transcranial magnetic stimulation dTMS will be presented Sunday at ENDO the Endocrine Societys th annual meeting in Orlando Fla. This study expands on the researchers previous finding that dTMS reduced food cravings and induced weight loss in obese individuals. Unlike deep brain stimulation dTMS does not need an operation or implantation of electrodes. Instead an electromagnetic coil is placed on the scalp and sends magnetic pulses to stimulate specific deep regions of the brain. Currently approved in the U.S. for treating major depression dTMS is being studied in some countries for the treatment of other neuropsychiatric disorders especially addiction. We need new safe and effective therapies for obesity said principal investigator Livio Luzi M.D. professor and head of endocrinology at the IRCCS Policlinico San Donato and the University of Milan in Milan Italy. Despite numerous preventive and therapeutic interventions none has stopped obesity from reaching epidemic proportions. An underlying cause of obesity may be an impaired gut microbiota composition an imbalance in the complex mix of beneficial and harmful microorganisms that inhabit the digestive tract. Luzi said scientists now know that an impaired gut microbiota can alter the brains signals for appetite and satiety or fullness. He and his coworkers studied whether dTMS could improve the gut microbiota composition in obese persons and if so by what underlying mechanisms. In their study funded by the Italian Ministry of Health the investigators recruited three men and women ages to with obesity as shown by a body mass index BMI of to kgm. They randomly assigned the study subjects to two groups for five weeks to receive sessionsthree times per weekof either dTMS to the insula and prefrontal cortex deep in the brain or a sham stimulation as a control. Before and at the end of treatment subjects provided stool samples for microbiota analysis. The research team also measured blood levels of glucose sugar insulin pituitary gland hormones and neurotransmitters such as norepinephrine. Pituitary hormones play a key role in regulating appetite and recent research shows that norepinephrine and other neurotransmitters affect microbiota composition Luzi said. After five weeks of treatment subjects receiving dTMS lost more than percent of their body weight and more than percent of their fatsignificantly more than controls did Luzi reported. Results of the fecal analysis demonstrated that after five weeks dTMStreated subjects had greatly increased quantities of several beneficial bacterial species with antiinflammatory properties such as are found in healthy people. The control group however had no clinically relevant alterations in their microbiota composition Luzi said. He also reported that changes in the abundance of other bacterial species correlated with improvement of metabolic and hormonal parameters including glucose insulin several pituitary hormones and norepinephrine. These changes suggest a beneficial effect of dTMS on both weight loss and change in microbiota composition Luzi said. Our research shows the innovative ability of dTMS in exerting antiobesity effects through alteration of the gutbrain axis. Endocrinologists are at the core of solving the most pressing health problems of our time from diabetes and obesity to infertility bone health and hormonerelated cancers. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormonerelated conditions. The Society has more than members including scientists physicians educators nurses and students in countries. To learn more about the Society and the field of endocrinology visit our site at http Follow us on Twitter at TheEndoSociety httpstwitter.comtheendosocietylangen and EndoMedia httpstwitter.comEndoMedia."

"Lovers of Indian food give yourselves a second helping Daily consumption of a certain form of curcumin the substance that gives Indian curry its bright color improved memory and mood in people with mild agerelated memory loss according to the results of a study conducted by UCLA researchers. The research httpsdoi.org.j.jagp... published online Jan. in the American Journal of Geriatric Psychiatry examined the effects of an easily absorbed curcumin supplement on memory performance in people without dementia as well as curcumins potential impact on the microscopic plaques and tangles in the brains of people with Alzheimers disease. Found in turmeric curcumin has previously been shown to have antiinflammatory and antioxidant properties in lab studies. It also has been suggested as a possible reason that senior citizens in India where curcumin is a dietary staple have a lower prevalence of Alzheimers disease and better cognitive performance. Exactly how curcumin exerts its effects is not certain but it may be due to its ability to reduce brain inammation which has been linked to both Alzheimers disease and major depression said Dr. Gary Small director of geriatric psychiatry at UCLAs Longevity Center and of the geriatric psychiatry division at the Semel Institute for Neuroscience and Human Behavior at UCLA https and the studys first author. The doubleblind placebocontrolled study involved adults between the ages of and years who had mild memory complaints. Participants were randomly assigned to receive either a placebo or milligrams of curcumin twice daily for months. All subjects received standardized cognitive assessments at the start of the study and at sixmonth intervals and monitoring of curcumin levels in their blood at the start of the study and after months. Thirty of the volunteers underwent positron emission tomography or PET scans to determine the levels of amyloid and tau in their brains at the start of the study and after months. The people who took curcumin experienced significant improvements in their memory and attention abilities while the subjects who received placebo did not Small said. In memory tests the people taking curcumin improved by percent over the months. Those taking curcumin also had mild improvements in mood and their brain PET scans showed significantly less amyloid and tau signals in the amygdala and hypothalamus than those who took placebos. The amygdala and hypothalamus are regions of the brain that control several memory and emotional functions. Four people taking curcumin and two taking placebos experienced mild side effects such as abdominal pain and nausea. The researchers plan to conduct a followup study with a larger number of people. That study will include some people with mild depression so the scientists can explore whether curcumin also has antidepressant effects. The larger sample also would allow them to analyze whether curcumins memoryenhancing effects vary according to peoples genetic risk for Alzheimers their age or the extent of their cognitive problems. These results suggest that taking this relatively safe form of curcumin could provide meaningful cognitive benefits over the years said Small UCLAs ParlowSolomon Professor on Aging. The papers authors in addition to Small are Prabha Siddarth Dr. Zhaoping Li Karen Miller Linda Ercoli Natacha Emerson Jacqueline Martinez KoonPong Wong Jie Liu Dr. David Merrill Dr. Stephen Chen Susanne Henning Nagichettiar Satyamurthy SungCheng Huang Dr. David Heber and Jorge Barrio all of UCLA. The study was supported by the Ahmanson Foundation the Marshall and Margherite McComb Foundation the McMahan Foundation Bob and Marion Wilson the Fran and Ray Stark Foundation Fund for Alzheimers Disease Research the U.S. Department of Energy and the National Institutes of Health. Theravalues Corp. provided the curcumin and placebos for the trial as well as funds for laboratory testing and for Smalls travel to present preliminary findings at the Alzheimers Association International Conference. SEE ORIGINAL STUDY http"

"A new treatment might open the door for more patients with advanced kidney disease to get a transplant a preliminary study suggests. Of the plus Americans waiting for a donor kidney about onethird are sensitized said Dr. Robert Montgomery director of the Transplant Institute at NYU Langone in New York City. Those patients face a tough situation They harbor immune system antibodies that are primed to attack a donor organ. The antibodies can form when a person is exposed to foreign tissue Montgomery explained. So a patient whos had a prior kidney transplant may be highly sensitized meaning they have a large number of the offending antibodies. It can also happen to patients whove had blood transfusion or ever been pregnant Montgomery said. Its almost impossible to find a compatible donor for those patients. But they might be able to receive a kidney from an incompatible donor if they first undergo an extensive desensitization process. That involves various treatments including IV drugs called immune globulin and rituximab that try to quash the antibodies that would attack the donor organ. Now the new research suggests a simple approach an infusion of a particular enzyme hours before the transplant could offer a better alternative. Researchers found that the treatment dubbed IdeS quickly wiped out the dangerous antibodies allowing all but one of patients to have a successful transplant. The findings were published in the Aug. issue of the New England Journal of Medicine. Funding for the study came from the company developing IdeS Hansa Medical. Montgomery who was not involved in the study said hes never seen anything like it. When you give this all of the antibodies are gone Montgomery said. Im hopeful that this will turn out to be a gamechanger. However he stressed many questions remain. Critically the enzyme does not banish the antibodies forever. They come back Montgomery said and the results of that comeback vary from patient to patient. In the study patients had an episode of antibodymediated rejection anywhere from two weeks to five months after their transplant. That means antibodies started to attack the new kidney. Those patients were all successfully treated with standard antirejection drugs according to the researchers. Still its not yet clear how the patients will fare in the long term said Dr. Julie Ingelfinger a professor at Harvard Medical School in Boston. Ingelfinger who wrote an editorial published with the study echoed Montgomerys cautious optimism. If larger longer studies bolster the current findings she said this could potentially be practicechanging. But Ingelfinger stressed only time will tell. Lead researcher Dr. Stanley Jordan agreed that more work is necessary. But the findings mark another step forward for patients like these according to Jordan who is medical director of the kidney transplant program at CedarsSinai in Los Angeles. Traditionally highly sensitized patients in need of a kidney have languished on waiting lists because its so hard to find a compatible donor. But in the past years or so desensitization has emerged as an alternative. Last year a landmark study proved that patients who receive transplants after desensitization live significantly longer than those who stay on dialysis. The outcomes have been good Jordan said. But he added theres clearly room for improvement. Ingelfinger agreed. The desensitization protocols now in use are timeconsuming and they dont always work she said noting that they can leave dangerous antibodies behind. Desensitization adds about to to the cost of the transplant according to the University of Wisconsins transplant center. The new approach is quite different Ingelfinger said. Patients receive one infusion of an enzyme called IdeS four to six hours before the transplant. The enzyme is derived from a strain of Streptococcus bacteria and it essentially chops up the antibodies that would attack the organ. Jordan acknowledged that the source sounds scary but stressed that patients do not receive the bacteria itself but an engineered version of the enzyme. In all U.S. and Swedish patients received an infusion of IdeS before their kidney transplant. All but one had a successful transplant and none had detectable antibodies immediately afterward. IdeS patients still received additional treatment including a week of immune globulin and rituximab infusions. And as with all transplants they needed standard antirejection drugs. Because IdeS so readily banishes the offending antibodies it might make transplants feasible for even the most highly sensitized patients Montgomery said. But the question remains he said Can it extend the survival of the donor kidney and ultimately patients lives IdeS is still experimental and the only way patients could receive it is through a clinical trial. It will be a few years before it could be more widely available Montgomery said. More information The National Kidney Foundation has more on kidney transplantation. https SOURCES Stanley Jordan M.D. medical director kidney transplant program CedarsSinai Medical Center Los Angeles Robert Montgomery M.D. director Transplant Institute and professor transplant surgery NYU Langone Medical Center New York City Julie R. Ingelfinger M.D. professor pediatrics Harvard Medical School Boston and deputy editor New England Journal of Medicine Aug. New England Journal of Medicine"

"In the first study of its kind researchers found realworld massage therapy to be an effective treatment for chronic low back pain. Niki Munk an assistant professor of health sciences in the School of Health and Rehabilitation Sciences at Indiana UniversityPurdue University Indianapolis and one of the cofirst authors of the study said that the studys findings are important given the large number of people who suffer low back pain in the U.S. Low back pain leads all disorders in years lost to disability in the U.S. Most patients improve rapidly but onethird report persistent back pain and percent develop chronic low back pain with significant physical limitations. More than percent of those who participated in the study experienced clinically meaningful improvements in their low back pain with disability according to Munk. The study can give primary care providers the confidence to tell patients with chronic low back pain to try massage if the patients can afford to do so Munk said. Generally massage is not covered by insurance Medicaid or Medicare. Previous studies of the effectiveness of massage were conducted in controlled research situations. In this study patients were referred by a physician to a massage therapist. The massage therapist designed and provided a series of massages at no cost to the patient in a clinical treatment environment mimicking the experience of people who choose to seek massage therapy in the real world. The study also looked at different characteristics associated with patients being more likely or less likely to experience clinically meaningful change from massage. Among the studys findings Adults in the babyboom and older generations tended to be much more likely to experience clinically meaningful changes. Obese patients experienced significant improvements but those improvements were not retained over time. Patients who were taking opioids experienced improvements in their pain from disability in some cases but were two times less likely to experience clinically meaningful change compared to those who were not taking opioids. While the study results are promising much more work needs to be done Munk said The fact of the matter is that chronic lower back pain is very complex and often requires a maintenancetype approach versus a shortterm intervention option. Additional investigation is needed to replicate the results of the initial study and to conduct a costbenefit analysis of massage therapy Munk said. Massage is an outofpocket cost she said. Generally people wonder if it is worth it. Will it pay to provide massage to people for an extended period of time Will it help avoid back surgeries for example that may or may not have great outcomes These are the types of analyses that we hope will result from this study. The study RealWorld Massage Therapy Produces Meaningful Effectiveness Signal for Primary Care Patients with Chronic Low Back Pain Results of a Repeated Measures Cohort Study was published online March in the journal Pain Medicine."

"In a firstofitskind study researchers demonstrate a benefit in overall survival among epithelial ovarian cancer EOC patients receiving generic heart medications known as betablockers. Survival was shown to be greatest among those prescribed firstgeneration nonselective betablockers. According to The University of Texas MD Anderson Cancer Center investigators the drugs block the effects of stress pathways involved in tumor growth and spread. With further research they may also prove beneficial in conjunction with other treatment regimens and across other cancer types. Published today in the journal CANCER the findings are the result of a multiinstitutional retrospective analysis of the medical records of women with ovarian cancer treated between and . Researchers compared overall survival among patients with documented betablocker use during chemotherapy and those without. Among the patients who received betablockers . percent received betaadrenergic receptor selective agents SBBs and the remaining patients received nonselective beta antagonists NSBBs. The research team found For patients receiving any betablocker the median overall survival was . months versus months for nonusers. Median overall survival based on betablocker receptor selectivity was . months for those receiving NSBBs versus months for those receiving SBBs. Even among patients with hypertension a longer median overall survival was observed among users of NSBBs compared with nonusers months versus . months. This study builds on a large body of research by principal investigator Anil Sood M.D. professor in Gynecologic Medical Oncology and Cancer Biology at MD Anderson. It showed that stress hormones fuel progression of ovarian and other cancers and that betablockers among the most proven drugs in cardiovascular medicine might be a new way to stifle that effect. Betablockers treat a variety of conditions such as heart disease highblood pressure glaucoma and migraines. They target a receptor protein in heart muscle that causes the heart to beat harder and faster when activated by stress hormones Sood said. Our research has shown that the same stress mechanisms impact ovarian cancer progression so these drugs could play a new role in cancer treatment. According to Sood the usefulness of betablockers was unclear until now. The ability to show improved survival using nonselective agents which inhibit a specific stress pathway is the culmination of years of research into ovarian cancer biology and pathogenesis. He added that betablocker users in the study presented at a higher stage of disease had an increased average BMI and were more likely to be hypertensive. All these factors were associated with decreased survival yet those who received betablockers had either equivalent or improved overall survival. Further examination revealed that NSBB users had improved overall survival regardless of the presence of such prognostic factors or comorbidities. This was not true for patients who took SBBs. Although further study is needed these results highlight the importance of adrenergic receptor ADRB a signaling pathway important to ovarian carcinogenesis and targeted by NSBBs versus the ADRB pathway targeted by SBBs. Ovarian cancer is the th most deadly cancer among women accounting for more deaths than any other female reproductive system cancer. An estimated new cases are diagnosed and some women die from the disease each year in the U.S. according to the American Cancer Society. Future trials will seek to identify patients who would benefit most from betablocker use and the best betablocker for a specific tumor type based on adrenergic receptor expression. Then they potentially could be used as an adjuvant therapy during surgical recovery and chemotherapy to decrease tumor growth delays in wound healing and metastasis. Betablockers may also reduce cancerrelated psychological distress in newly diagnosed patients according to the study authors. There are currently two clinical trials one led by MD Anderson evaluating the combination of chemotherapy and propranolol a type of NSBB on cancer biology and on stress modulators in patients with newly diagnosed EOC. According to Sood the preliminary data from these feasibility trials will be used to design prospective randomized clinical trials examining NSBBs on patient outcomes. The stratification of patients by betablocker use and selectivity in this study makes it unique among all other studies examining the impact of these drugs on cancer. It also builds on the mounting evidence that betablockers may become a key treatment component for many patients in the future said Sood. Portions of this study were supported by National Institutes of Health grants CA CA CA PCA UCA UCA UCA and CA an Ovarian Cancer Research Fund program Project Development Grant the Department of Defense grants OC WXWJ and OC the Betty Ann Asche Murray Distinguished Professorship the RGK Foundation the Gilder Foundation the BlantonDavis Ovarian Cancer Research Program and a Gynecologic Cancer FoundationSt. Louis Ovarian Cancer Awareness grant. One of the researchers has acted as a paid consultant for Incyte Pharmaceuticals and received research funding from Egen Pharmaceuticals. Other researchers contributing to this study include Robert L. Coleman M.D. Alpa M. Nick M.D. Pedro T. Ramirez M.D. Lois M. Ramondetta M.D. Diana Urbauer Jack L. Watkins all from MD Anderson Susan K. Lutgendorf Ph.D. from University of Iowa Sanjeev Kumar M.B. B.S. from the Mayo Clinic Koji Matsuo M.D. from Mercy Medical Center Kathryn Squires M.D. and Premal H. Thaker M.D. M.S. from Washington University School of Medicine."

"The U.S. Food and Drug Administration today approved Nuplazid pimavanserin tablets the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinsons disease. Hallucinations or delusions can occur in as many as percent of patients with Parkinsons disease at some time during the course of their illness. People who experience them see or hear things that are not there hallucinations andor have false beliefs delusions. The hallucinations and delusions experienced with Parkinsons disease are serious symptoms and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves. Hallucinations and delusions can be profoundly disturbing and disabling said Mitchell Mathis M.D. director of the Division of Psychiatry Products in the FDAs Center for Drug Evaluation and Research. Nuplazid represents an important treatment for people with Parkinsons disease who experience these symptoms. An estimated Americans are diagnosed with Parkinsons disease each year according to the National Institutes of Health and about one million Americans have the condition. The neurological disorder typically occurs in people over age when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth purposeful movement like eating writing and shaving. Early symptoms of the disease are subtle and occur gradually. In some people Parkinsons disease progresses more quickly than in others. As the disease progresses the shaking or tremor which affects the majority of people with Parkinsons disease may begin to interfere with daily activities. Other symptoms may include depression and other emotional changes hallucinations and delusions difficulty in swallowing chewing and speaking urinary problems or constipation skin problems and sleep disruptions. The effectiveness of Nuplazid was shown in a sixweek clinical trial of participants. Nuplazid was shown to be superior to placebo in decreasing the frequency andor severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinsons disease. As with other atypical antipsychotic drugs Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementiarelated psychosis. No drug in this class is approved to treat patients with dementiarelated psychosis. In clinical trials the most common side effects reported by participants taking Nuplazid were swelling usually of the ankles legs and feet due to the accumulation of excessive fluid in the tissue peripheral edema nausea and abnormal state of mind confused state. Nuplazid was granted breakthrough therapy designation http for the treatment of hallucinations and delusions associated with Parkinsons disease. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The drug was also granted a priority review. The FDAs priority review http program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment prevention or diagnosis of a serious condition. Nuplazid is marketed by Acadia Pharmaceuticals Inc. of San Diego California. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."

"Cognitive behavioral therapy which traditionally includes regular and often weekly visits to a clinician is recommended by the American College of Physicians and other organizations for treatment of chronic insomnia. For military personnel internetdelivered cognitive behavioral therapy appears to be an effective alternative to meeting regularly with a therapist although it is about half as effective as traditional methods according to results of a study conducted by Daniel Taylor University of North Texas professor of psychology and director of UNTs Sleep Health Research Laboratory. Taylor received a . million grant from the U.S. Department of Defense for the study which was affiliated with the STRONG STAR Consortium a federally funded network of national experts seeking the best ways to treat behavioral health problems impacting post service members and veterans. The study was published in SLEEP the official journal of the Sleep Research Society. Chronic insomnia is defined by the Diagnostic and Statistical Manual of Mental Disorders as sleeping poorly at least three nights a week for a month or longer despite adequate opportunity for a full nights sleep. It is a significant problem in the military said Taylor who noted that military personnel often develop insomnia because of rapidly changing schedules and deployments that keep them constantly on alert. Chronic insomnia is a strong risk factor for posttraumatic stress disorder depression and substance abuse absenteeism and occupational accidents Taylor said. Treatment of insomnia may not only improve sleep in these soldiers but also improve these other conditions he said. About percent of deployed military personnel take sleep medications which are effective for shortterm treatment of insomnia in civilian populations. For deployed military personnel the side effects such as grogginess slowed cognitive processing and slowed reaction time can be dangerous Taylor said. One hundred soldiers at Fort Hood who had chronic insomnia were recruited for Taylors study. All completed one week of sleep monitoring by keeping sleep diaries and wearing activity monitors. One third of the participants met with clinicians at Fort Hood for cognitive behavioral therapy for insomnia once a week for six weeks while another third received the therapy via the Internet once a week for six weeks. Both the inperson and Internet therapy had the exact same content with the Internet lessons presented as audio recordings accompanied by visual graphics and animations. A third control group of participants was contacted by the researchers every other week during the six weeks but did not receive cognitive behavioral therapy. Taylor discovered that the study participants who received inperson cognitive behavioral treatment for their insomnia reported significantly greater improvements in sleep quality as determined by the sleep diaries and activity monitors than those who received the Internet therapy. Both groups had greater improvements in sleep quality than those who did not receive cognitive behavioral therapy. He noted that that cognitive behavioral therapy is a multifaceted intervention that can be difficult to administer without the benefit of a therapist. Additional training in the therapy for behavioral health providers in all branches of the military is needed he said. In a previous study of civilians with insomnia Taylor and his research team discovered that cognitive behavioral therapy led to significant improvements in sleep efficiency with the research subjects use of sleep medication declining from . percent before therapy to percent afterward although the subjects werent required to stop taking their medication. Kristi Pruiksma a STRONG STAR collaborating investigator and clinical psychologist served as a clinician on Taylors study. She said the benefits of the online therapy include easy access to the treatment and flexibility in times for completing the sessions which is really helpful for those juggling work and family demands. The online program can also be done from home rather than at a military behavioral health clinic which some service members may avoid due to concerns about stigma said Pruiksma an assistant professor of psychiatry at the University of Texas Health Science Center at San Antonio UT Health San Antonio. Successful treatment has a real impact on patients daily lives. An important next step will be to figure out who is able to achieve good benefits from the online program and who is likely to need additional assistance from a therapist she said."

"GenomeDx Biosciences today announced that a study featured on the cover of Urology demonstrates that Decipher Prostate Cancer Classifier significantly influenced treatment recommendations following prostate surgery reducing disagreement between urologists and radiation oncologists and has the potential to enhance personalization of patient care. Decipher is a Medicarecovered genomic test capable of predicting tumor aggressiveness in men following prostate surgery. The study titled Impact of a Genomic Classifier of Metastatic Risk on Postprostatectomy Treatment Recommendations by Radiation Oncologists and Urologists http was published in this months issue of Urology. Conflicting treatment recommendations by different specialists looking at the same disease can be highly confusing for patients and is a problem for the health care system in general said Paul Nguyen M.D. of DanaFarberBrigham and Womens Cancer Center and Harvard Medical School. The Decipher tests tendency to make the two specialties more concordant in their treatment recommendations provides significant value toward standardizing care for patients. The study was designed to evaluate how the Decipher Prostate Cancer Classifier which predicts the risk of metastasis after prostatectomy would impact adjuvant treatment recommendations made by urologists and radiation oncologists. These two specialties often disagree on which patients should receive radiation therapy following surgery and when. Using clinical information alone observation rather than adjuvant radiation therapy was recommended in of decisions made by urologists and of decisions by radiation oncologists P .. The Decipher test results altered and of treatment recommendations made by urologists and radiation oncologists respectively. Decipher results indicating genomic high risk resulted in intensification of treatment whereas genomic low risk resulted in less aggressive recommendations. The Decipher results increased agreement in treatment recommendations between urologists and radiation oncologists as the odds of a recommendation for adjuvant treatment by urologists vs radiation oncologists increased from . CI .. to . CI .. after results of the Decipher test were made available. It is notable that while the Decipher test significantly influenced treatment decisions it did not increase the total number of people receiving adjuvant therapy suggesting that it helped ensure that the ones selected for adjuvant therapy are the ones most likely to benefit from it said Doug Dolginow M.D. chief executive officer of GenomeDx. As genomic tests like Decipher become used more routinely in urologic cancer patient care they will have a greater impact on treatment recommendations in clinical practice and allow for better personalization of therapy. The Decipher test used in this study has been previously described in multiple blinded independent validation studies in men at high risk of recurrence at the time of prostatectomy. Researchers found that of the clinically highrisk men would be reclassified as low risk based on the Decipher test and have only a . risk of metastasis at years after surgery. In addition the of the patients with the highest risk based on Decipher had a nearly fold higher risk of distant metastases by years. The test provided a more accurate and precise estimate of a patients risk of recurrence. Use of this test therefore has the potential to assist clinicians to better direct utilization of secondary therapy after surgery. About Decipher The Decipher Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decisionmaking process Decipher generates a risk result that is completely independent and distinct from PSA Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease which men may benefit from radiation therapy following prostate surgery and can lead to significant costsavings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic. Decipher is covered by Medicare and multiple private insurance plans in the US. Learn more at http and follow Decipher on Twitter DecipherTest http and on Facebook. About GenomeDx Biosciences GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers the company has assembled the largest genomic catalogue of prostate cancer tumors in the world representing billions of data points and more than years of prostate cancer research expertise. Using advanced cloudbased bioinformatics GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinicianscientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego California and Vancouver British Columbia. Learn more at http and follow us on Twitter at Twitter GenomeDx http Facebook LinkedIn httpca.linkedin.comcompanygenomedxbiosciencesinc. and YouTube http Media Contact for GenomeDx Biosciences Ian Stone Canale Communications iancanalecomm.com mailtoiancanalecomm.com SOURCE GenomeDx Biosciences Related Links httpgenomedx.com"

"About million Americans have sleep apnea httpshealth.nytimes.comhealthguidesdiseasesleepapneaoverview.htmlinlinenytclassifier which causes repeated awakenings and pauses in breathing during the night sometimes resulting in loud snoring httpshealth.nytimes.comhealthguidessymptomssnoringoverview.htmlinlinenytclassifier and gasps for air. For decades the standard treatment has been continuous positive airway pressure. A mask worn at night pushes air into the nasal passages enabling easier breathing. C.P.A.P. reduces and in some cases completely prevents episodes of apnea httpshealth.nytimes.comhealthguidessymptomsbreathingslowedorstoppedoverview.htmlinlinenytclassifier. The new device has two small plugs that create just enough air pressure to keep the airways open at night.Credit Joseph A. Golish M.D. But the mask is like something from a bad science fiction movie big bulky and obtrusive. Many patients simply refuse to wear it or rip it off while asleep. Studies show that about half of all people prescribed C.P.A.P. machines stop using them in one to three weeks httpsarchinte.amaassn.orgcgicontentfull. For a lot of people out there the C.P.A.P. machine turns into a doorstop said Dr. Joseph Golish the former chief of sleep medicine at the Cleveland Clinic and now a professor with the MetroHealth System in Cleveland. C.P.A.P. is very effective in the sleep lab. But when people go home theres a good chance they wont use it and the success rate of an unused C.P.A.P. machine is absolutely zero. Now an alternative form of C.P.A.P. is gaining popularity a patch that fits over the nostrils. Called Provent the patch holds two small plugs one for each nostril that create just enough air pressure to keep the airways open at night. It is far less intrusive than the traditional C.P.A.P. machine. It is also more expensive and it doesnt work for every patient. Share your thoughts. Join in the discussion. httpswell.blogs.nytimes.comtreatingsleepapneawithoutthemask Approved by the Food and Drug Administration in Provent has spread mostly by word of mouth. But it has caught on fast. Its manufacturer Ventus Medical says it has shipped one million of the devices in the past months up from a half million total in the two years prior. Doctors say it has given them a new weapon in the battle against sleep apnea and many patients who struggled with C.P.A.P. call it a godsend. Bob Bleck who owns a computer networking firm in Ohio struggled with poor sleep and chronic fatigue httpshealth.nytimes.comhealthguidesdiseasechronicfatiguesyndromeoverview.htmlinlinenytclassifier for decades. But it was only a year and a half ago that he finally went to a sleep clinic prodded by his wife who worried about his heavy snoring. The diagnosis was severe sleep apnea. Tests showed that in a typical night Mr. Bleck awoke or stopped breathing times an hour. His doctor prescribed a C.P.A.P. machine and Mr. Bleck hated it. I had this constricted feeling he said. It would be incorporated into these dreams where I was tied up like in the movie Alien. It was more difficult to sleep with that thing on than to just get through the night with the apnea. Mr. Bleck got rid of the machine after he discovered Provent. After I started using it I noticed a difference right away he said. My symptoms subsided dramatically. Provent works like a traditional C.P.A.P. machine but is only a fraction of the size. When people with apnea fall asleep their throat muscles collapse constricting the airway and causing the body to fight for air. C.P.A.P. machines use mild air pressure to keep the airway from constricting. Provent does too but in a different way. The device contains two pinholesize valves one over each nostril. The valves let air in easily most people breathe through their nostrils while asleep but there is resistance as the user exhales. That resistance creates a backpressure in the airways dilating the muscles that would otherwise collapse in the middle of the night. In the morning the patch is removed a new one is used every night. Last year in a large study of apnea sufferers published in the medical journal Sleep https and subsidized by Ventus researchers found that those who used Provent devices over a threemonth period saw their apnea episodes fall sharply compared with people who were given a sham or placebo device. A followup study tracked people over the course of a year and had similar results. But not everyone finds that Provent alleviates their apnea. In interviews sleep specialists said that a third or more of patients do not end up using it. It works like a champ in some people and doesnt work on other people said Dr. Nancy Appelblatt an ear nose and throat surgeon in Sacramento who has prescribed it to about patients. All sleep apnea is not created equal. Some people for example breathe through the mouth at night not the nostrils. In those people Provent typically doesnt work. Nor will it work very well in someone who has severe nasal allergies httpshealth.nytimes.comhealthguidesdiseaseallergicrhinitisoverview.htmlinlinenytclassifier and has a blocked nose at night said one of the leaders of the Provent studies Dr. Meir H. Kryger a professor at Yale Medical School and founder of the National Sleep Foundation. Unlike C.P.A.P. Provent is not covered by Medicare and most major insurers though some doctors say they expect that will change in the near future. In the meantime a day supply of the patches costs to . Dr. Lee A. Surkin a cardiologist and sleep medicine specialist in Greenville N.C. said patients typically start with a day trial pack that costs .. He has prescribed Provent to about of his patients. The No. reason people dont continue it is the outofpocket expense he said. For now Dr. Kryger and others say that C.P.A.P. will continue to be the gold standard and certainly the first option for patients with severe apnea. But for the roughly percent of patients in whom C.P.A.P. fails Provent may be a reliable alternative. Dr. Surkin said some patients use C.P.A.P. at home but take their pocketsize Provent patches with them when they travel to avoid the hassle of lugging a machine through airports. To me its a miracle said Joyce Nemoga . Ms. Nemoga who lives in Baldwin Harbor N.Y. has moderate apnea that caused her to snore and gasp in her sleep. She tried C.P.A.P. but could not sleep comfortably with the device. Every time you turn over you have to take the hose with you she said. I tried it for six months and I dont think I had one full night of sleep the whole time. A doctor suggested Provent and Ms. Nemoga saw quick results. Im just so happy that I found it she said."

"The gene responsible for cystic fibrosis httpshealth.nytimes.comhealthguidesdiseasecysticfibrosisoverview.htmlinlinenytclassifier was discovered in . Now years later a drug that tries to compensate for the genetic defect might be nearing the market. Vertex Pharmaceuticals https announced Wednesday morning that the drug VX https improved lung function in people with cystic fibrosis in a latestage clinical trial. The drug also reduced the frequency of disease exacerbations that required treatment with antibiotics httpstopics.nytimes.comtopnewshealthdiseasesconditionsandhealthtopicsantibioticsindex.htmlinlinenytclassifier. The caveat is that VX is designed to counter one specific genetic mutation that accounts for about percent of cases of cystic fibrosis. Vertex is working on another drug for the most common mutation but that one is further behind in development. Still the news is expected to be greeted favorably by doctors and patients and by Wall Street. Ive been doing clinical trials for years in C.F. and these are amazing results Dr. Bonnie W. Ramsey https_Bonnie.html a lead investigator in the trial said in an interview. Dr. Ramsey a professor of pediatrics httpstopics.nytimes.comtopnewshealthdiseasesconditionsandhealthtopicspediatricsindex.htmlinlinenytclassifier at the University of Washington httpstopics.nytimes.comtopreferencetimestopicsorganizationsuuniversity_of_washingtonindex.htmlinlinenytorg was briefed on the results by Vertex. The results were announced by a press release httpsinvestors.vrtx.comreleasedetail.cfmReleaseID and have not been peer reviewed by experts. About Americans and people worldwide have cystic fibrosis a disease caused by defects in a gene responsible for the transport of chloride ions across cell membranes. People with the disease tend to have very thick mucus in their lungs which leads to infections and lung damage. Many do not live past age . Two inhaled antibiotics and one drug that loosens mucus are approved to treat cystic fibrosis but nothing that directly improves chloride ion transport. In the trial those who received VX gained . percentage points more on a lung function test after weeks than those getting a placebo a difference that statistically was highly significant. Patients continued to take either drug or placebo for another weeks and the improvement was sustained. Lung function the primary endpoint of the trial was measured by how much a person could exhale in one second a standard test. Investors had been expecting around a percentage point improvement. In a note to clients Tuesday evening before the results were known an analyst at ISI Group Mark Schoenebaum https said that an improvement of percent would be a home run that could lead to million in annual sales for the drug. Dr. Ramsey who has received research grants from Vertex said that some patients could perceive a percentage point change in lung function. She said other results of the trial were encouraging. These included fewer exacerbations of the disease in those who got the drug fewer selfreported respiratory symptoms and a gain in weight which is good for people with cystic fibrosis who often have digestive problems. The saltiness of their sweat a measure used to diagnose the disease was markedly reduced suggesting that the drug was having an effect on chloride ion transport. The trial involved people age and older all with at least one copy of the particular mutation known as GD. The main side effects Vertex said were headache httpshealth.nytimes.comhealthguidessymptomsheadacheoverview.htmlinlinenytclassifier upper respiratory tract infections nasal congestion httpshealth.nytimes.comhealthguidessymptomsnasalcongestionoverview.htmlinlinenytclassifier rash and dizziness httpshealth.nytimes.comhealthguidessymptomsdizzinessoverview.htmlinlinenytclassifier. Vertex said it hoped to apply in the second half of the year for approval of VX in the United States and Europe. The company is awaiting results of a second trial of the drug this one in younger children. Vertex has not said how much it will charge for VX. But since there are only about Americans who are candidates for the drug the price is likely to be tens of thousands of dollars a year. Vertex based in Cambridge Mass. was founded in coincidentally the same year the cystic fibrosis gene was discovered. It has not yet had a big commercial success and had a . billion net loss in the last five years. The company is hoping that by late May it will win approval to sell a new type of drug for hepatitis C httpshealth.nytimes.comhealthguidesdiseasehepatitiscoverview.htmlinlinenytclassifier which analysts expect will be a blockbuster. The long time needed to develop a drug for cystic fibrosis is a lesson for those expecting a quick payout from the sequencing of the human genome which was completed a decade ago. It is not enough to know the gene behind a disease. It can take years of research to determine how a mutation actually causes a disease and then to design a drug that corrects the problem. Vertex received million in financial support from the Cystic Fibrosis Foundation one of the first nonprofit disease groups to give money to companies. These results are highly encouraging Robert J. Beall president of the foundation said in a statement Wednesday. They provide scientific evidence that support our longstanding belief that targeting the underlying defect of C.F. may have a profound effect on the disease."

"A procedure used to relieve chest pain in hundreds of thousands of heart patients each year is useless for many of them researchers reported on Wednesday. Their study focused on the insertion of stents tiny wire cages to open blocked arteries. The devices are lifesaving when used to open arteries in patients in the throes of a heart attack. But they are most often used in patients who have a blocked artery and chest pain that occurs for example walking up a hill or going up stairs. Sometimes patients get stents when they have no pain at all just blockages. Heart disease is still the leading killer of Americans people have heart attacks each year and stenting is a mainstay treatment in virtually every hospital. More than heart patients worldwide have stents inserted each year to relieve chest pain according to the researchers. Other estimates are far higher. Several companies including Boston Scientific Medtronic and Abbott Laboratories sell the devices and inserting them costs from to httphealth.costhelper.comstents.html at hospitals in the United States. The new study http published in the Lancet stunned leading cardiologists by countering decades of clinical experience. The findings raise questions about whether stents should be used so often or at all to treat chest pain. Its a very humbling study for someone who puts in stents said Dr. Brahmajee K. Nallamothu an interventional cardiologist at the University of Michigan. Dr. William E. Boden a cardiologist and professor of medicine at Boston University School of Medicine called the results unbelievable. Dr. David Maron a cardiologist at Stanford University praised the new study as very well conducted but said that it left some questions unanswered. The participants had a profound blockage but only in one artery he noted and they were assessed after just six weeks. Editors Picks https_idWe dont know if the conclusions apply to people with more severe disease Dr. Maron said. And we dont know if the conclusions apply for a longer period of observation. For the study Dr. Justin E. Davies a cardiologist at Imperial College London and his colleagues recruited patients with a profoundly blocked coronary artery and chest pain severe enough to limit physical activity common reasons for inserting a stent. All were treated httpswe.tlxMlsGYBfor six weeks with drugs to reduce the risk of a heart attack like aspirin a statin and a blood pressure drug as well as medications that relieve chest pain by slowing the heart or opening blood vessels. Then the subjects had a procedure a real or fake insertion of a stent. This is one of the few studies in cardiology in which a sham procedure was given to controls who were then compared to patients receiving the actual treatment. In both groups doctors threaded a catheter through the groin or wrist of the patient and with Xray guidance up to the blocked artery. Once the catheter reached the blockage the doctor inserted a stent or if the patient was getting the sham procedure simply pulled the catheter out. Sign up for Science Times Well bring you stories that capture the wonders of the human body nature and the cosmos. Jim Stevens a lawyer in Troy Mich. was about to have a stent put in but the new study gave his cardiologist pause. He advised against inserting the stent and Mr. Stevens concurred.CreditSean Proctor for The New York Times Jim Stevens a lawyer in Troy Mich. was about to have a stent put in but the new study gave his cardiologist pause. He advised against inserting the stent and Mr. Stevens concurred.CreditSean Proctor for The New York Times Neither the patients nor the researchers assessing them afterward knew who had received a stent. Following the procedure both groups of patients took powerful drugs to prevent blood clots. The stents did what they were supposed to do in patients who received them. Blood flow through the previously blocked artery was greatly improved. When the researchers tested the patients six weeks later both groups said they had less chest pain and they did better than before on treadmill tests. But there was no real difference between the patients the researchers found. Those who got the sham procedure did just as well as those who got stents. Cardiologists said one reason might be that atherosclerosis affects many blood vessels and stenting only the largest blockage may not make much difference in a patients discomfort. Those who report feeling better may only be experiencing a placebo effect from the procedure. All cardiology guidelines should be revised Dr. David L. Brown of Washington University School of Medicine and Dr. Rita F. Redberg of the University of California San Francisco wrote in an editorial published with the new study. Clinical guidelines in the United States say stenting is appropriate for patients with a blocked artery and chest pain who have tried optimal medical therapy meaning medications like those given to the study patients. But those guidelines were based on studies in which patients simply said they felt better after having stents inserted. It was impressive how negative it was Dr. Redberg said of the new study. Since the procedure carries some risks including death stents should be used only for people who are having heart attacks she added. Stents came into wide use in the s and became the treatment of choice because they were less invasive than bypass surgery. But there have long been questions about their effectiveness. A large federally funded study https with Dr. Maron as a coprincipal investigator which does not have an untreated control group is now underway to determine whether medications can be just as effective as stenting or coronary bypass in preventing heart attacks. In another large study http led by Dr. Boden also without an untreated control group found stents did not prevent heart attacks or deaths from heart disease. The explanation researchers said was that atherosclerosis is a diffuse disease. A few arteries might be blocked today and then reopened with stents. But tomorrow a blockage might arise in another artery and cause a heart attack. Relieving chest pain though seemed a different goal to many cardiologists. After all the heart is a muscle and if a muscle is starved for blood it aches. Many patients have coronary arteries that are to percent blocked. Surely opening those vessels should make the patients feel better. Mr. Stevens was on the operating table to receive a stent through his wrist when his cardiologist Dr. Brahmajee K. Nallamothu had second thoughts and ended the procedure.CreditSean Proctor for The New York Times Mr. Stevens was on the operating table to receive a stent through his wrist when his cardiologist Dr. Brahmajee K. Nallamothu had second thoughts and ended the procedure.CreditSean Proctor for The New York Times The idea that stenting relieves chest pain is so ingrained that some experts said they expect most doctors will continue with stenting reasoning that the new research is just one study. Even Dr. Davies hesitated to say patients like those he tested should not get stents. Some dont want drugs or cant take them he said. Stenting is so accepted that American cardiologists said they were amazed ethics boards agreed to a study with a sham control group. But in the United Kingdom said Dr. Davies getting approval for the study was not so difficult. Neither was it difficult to find patients. There are many people who are open to research and if you tell them you are exploring a question people agree he said. Nonetheless it took him three and a half years to find the subjects for his study. Ethics boards at many American hospitals probably would resist since giving such patients fake procedures flies in the face of guidelines Dr. Boden said. Placebo effects can be surprisingly powerful said Dr. Neal Dickert Jr. a cardiologist and ethicist at Emory University. A few years ago researchers at the insistence of the Food and Drug Administration did a study http to test an invasive procedure to treat high blood pressure. The control group got a sham procedure. The method was becoming popular in Europe but the study found that blood pressure dropped just as much in those who had the fake treatment. Dr. Dickert said he hoped the new stent study will show cardiologists that they need to do more studies with sham procedures. This may turn out to be an important moment he said. But getting them underway in the United States may not be easy. Ethics boards at hospitals and universities are likely to resist as are patients. Its not just up to us said Dr. David Goff director of cardiovascular sciences at the National Heart Lung and Blood Institute. Still the results of the new research have at least one heart specialist rethinking his practice. Dr. Nallamothu got an advance look at the new paper on Tuesday. Coincidentally he had a patient Jim Stevens a lawyer in Troy Mich. scheduled to receive a stent that day. Mr. Stevens had a blocked artery but the new report gave Dr. Nallamothu second thoughts. I took him off the table he said. He explained to Mr. Stevens and his wife that he did not need a stent. I was surprised Mr. Stevens said. But I feel better not needing it."

"Alzheimers disease can be heartbreaking to watch and frustrating to treat. Most medicines on the market do little more than delay the inevitable mental decline. But a new drug called Dimebon appears to stop and perhaps even reverse the symptoms of the cruel and degenerative disease according to a new study published in the journal Lancet today. I was pleasantly surprised to see the effect on cognitive function on memory on activities of daily living that not only were clearly significant but seemed to increase over time said Dr. Sam Gandy former chairman of the Alzheimers Association Medical and Scientific Advisory Council. Dimebon wasnt designed to treat Alzheimers disease. Far from it. Its an antihistamine that was supposed to treat allergies. But a study that tracked mild to moderate Alzheimers patients for a year and found that at six months those taking Dimebon three times a day showed significant improvement in mental tests and cognitive functioning while those placed on the placebo kept deteriorating. A year into the study the Dimebon group was still improving while those without the drug were declining rapidly. Whats most encouraging for researchers is that current Alzheimers drugs lose their effectiveness after three or six months. But Dimebon still worked after at least a year and seemed to be improving with time. For those five million Americans living with Alzheimers disease memories tend to be lost first and then its victims lose the ability to care for themselves. Currently there is no cure for Alzheimers so eventually they lose their lives. Those with Alzheimers in the moderate to severe stages often lose the ability to complete daily tasks such as dressing themselves walking and eating. Karen Henes of CrotononHudson N.Y. was diagnosed with Alzheimers just a year ago and already complains of some such symptoms. I would like to just go see my grandchildren. I cant Henes said. Im not responsible enough just to drive. I cant always remember what to do. Its really sad. Her husband Michael expressed equal frustration with the disease. Life with Karen is so frustrating. It has already changed he said. She writes down all her appointments and she still doesnt remember them. On a daytoday basis its a struggle. Dimebon has been shown to improve patient memory and skills and to help on small daily tasks like using the telephone shopping and remembering the grocery list. Doctors havent yet figured out exactly how the drug works. Researchers think that the drug affects the mitochondria or the energy powerhouses of the brain cells. There are two major classes of Alzheimers drugs and researchers think that Dimebon performs both functions. Alzheimers patients families and doctors tend to be skeptical of new drugs because so many have fallen short over the years. Dr. Gandy cautioned that the new study was small. Dimebon must go through more clinical tests. And even if theyre a success it will be at least two years before Dimebon is approved for treatment by the Federal Drug Administration. This is promising but its not marketed anywhere in the world right now and it hasnt been approved in any country said Dr. Rachelle Doody the studys principal investigator and Effie Marie Cain chair in Alzheimers disease research at Baylor College of Medicine. This is coming along she told ABC News. Its coming along pretty quickly relative to other agents but this drug and all the others are not cures for the disease. Alzheimers patients like Henes are optimistic. I cant wait. I am so excited about the possibility Henes said. If I can stay the way I am now until a drug that comes along I will be a lucky person. To learn more about participating in the Phase III clinical trials of Dimebon visit this site http or call ...."

"For patients whose high blood pressure cannot be controlled despite taking several medications a short burst of radio waves at the nerves around the kidneys may do the trick a small new study says. The treatment was effective for at least six months. The findings could be a significant step in treating people with resistant hypertension which is a major risk factor for heart attack and stroke the researchers said. The technique called catheterbased renal denervation is minimally invasive. In it doctors use a catheter inserted through the artery in the groin which sends radio waves burning away nerve tissue around the arteries that feed the kidneys. The procedure destroys nerves that help control and filter salt in the body and may be overactive in patients with high blood pressure. The U.S. Food and Drug Administration has not yet approved its use. The study was funded by medical device maker Medtronic. The findings were published Dec. in the journal Circulation. This is a very promising approach for managing medicationresistant hypertension said Dr. Gregg Fonarow a spokesman for the American Heart Association and professor of cardiology at the University of California Los Angeles. High blood pressure is a major contributor to heart attack stroke heart failure and kidney failure said Fonarow who was not involved in the study. Despite the availability of a number of effective medications many patients with hypertension have not achieved adequate control of their blood pressure. There is thus an important but currently unmet need for additional therapies to effectively control hypertension. For the study an international team lead by Dr. Murray Esler professor and senior director of the Baker IDI Heart and Diabetes Institute in Melbourne Australia assigned patients to renal denervation and compared them to patients who had already had the procedure. All the patients suffered from drugresistant hypertension. Their systolic blood pressure the top number in a bloodpressure reading remained dangerously high at millimeters of mercury mmHg or above despite having taking three or more drugs to control blood pressure the researchers noted. Eslers team found that more than percent of those who had denervation treatment before had a drop in systolic blood pressure of at least mmHg after six months and almost percent maintained the reduction at months. The patients in this phase of the study had similar results to the initial group. Almost percent of these patients saw a reduction in systolic blood pressure of mmHg or more six months after treatment. Fonarow noted In all reductions in systolic bloodpressure levels on the order of to mmHg were achieved and maintained without any loss in efficacy. The procedure is safe as well as effective the study authors said. Participants kidneys were not damaged or functionally impaired Esler said in a journal news release. We also found no ill effects on longterm health from the procedure. Whether this technique might be useful in treating less severe high blood pressure hasnt yet been tested. If it is applicable it could mean patients need not take bloodpressure drugs Esler suggested. Another expert however said that scenario is likely overoptimistic. Hypertension is a hard disease to treat because there are so many things that go into getting blood pressure under control said Dr. Varinder Singh chairman of cardiology at Lenox Hill Hospital in New York City. Theres lifestyle and diet there is getting to the right doses of medications there are adherence issues. So anything that will help patients get their goals is exciting. Even with this technique people will most likely still have to take bloodpressure medications Singh said. You may have to take less medication and you may have to take lower doses of medication but we all expect that patients will still have to take some medication he said. Singh also noted that although this procedure is used in other countries it is not yet approved in the United States. Fonarow added While this study demonstrates that renal denervation provides sustained reduction of blood pressure up to one year and appears safe additional studies with longerterm followup are needed. According to the American Heart Association more than million adults in the United States have high blood pressure which is blood pressure higher than mmHg. Among these adults about percent have resistant hypertension which means that even taking three or more medications to control their blood pressure it remains higher than mmHg. More information To learn more about hypertension visit the U.S. National Library of Medicine http SOURCES Gregg Fonarow M.D. spokesman American Heart Association and professor of cardiology University of California Los Angeles Varinder Singh M.D. chairman of cardiology Lenox Hill Hospital New York City American Heart Association news release Dec. Circulation"

"Measuring blood levels of the recently discovered hormone irisin may improve diagnosis rates of teenagers with polycystic ovary syndrome according to research presented today at the th Annual European Society for Paediatric Endocrinology Meeting. The findings may reduce the number of unnecessary treatments prescribed to otherwise healthy girls. Polycystic ovary syndrome PCOS is a common endocrine disorder affecting up to of women. Women with PCOS are more likely to suffer from irregular periods have excessive levels of male hormones and may have difficulty in conceiving due to irregularities in the ovaries. Doctors are cautious when diagnosing PCOS in teenagers because the symptoms can be confused with normal pubertal changes. Having tools that make diagnoses more accurate can reduce unnecessary treatment for otherwise healthy teenagers at a critical stage in their lives. The cause of PCOS is unknown and there is currently no cure for the condition. Previous studies have associated high levels of irisin a newly discovered hormone which is released from muscles and regulates energy metabolism with PCOS in adults. In this study Greek researchers from Aghia Sophia Childrens Hospital in Athens compared the hormones of teenagers with PCOS with healthy teenagers of the same age and BMI. They found that teenagers with PCOS had significantly higher irisin levels compared to the control group and that this was associated with higher levels of the male sex hormone testosterone a key marker of PCOS. The findings suggest that irisin could be a marker for PCOS allowing the condition to be diagnosed more easily. Teenagers who get an early diagnosis of PCOS can sooner start to deal with the physical and psychological symptoms caused by this lifelong condition said lead researcher Dr Flora Bacopoulou. Whether its through counselling or medication girls can manage their symptoms and decrease the risk of further complications such as fertility problems hirsutism excessive hair growth and type diabetes. The group will next focus on confirming their results and investigate the biological role of irisin in PCOS. If high irisin levels in teenagers with PCOS is established this could lead to the development of treatments for PCOS. Lifestyle changes and different exerciserelated signals that regulate the secretion of irisin could provide a potential option for the management of PCOS. The potential of irisin as a meaningful drug target in PCOS is very promising said Dr Bacopoulou."

"An experimental therapy involving stem cell https injections from the patients own blood https is showing promise in the treatment of people with chest pain https that is not responsive to drugs angioplasty https or surgery. Results from a pivotal study of the treatment were reported today in the American Heart https Association AHA journal Circulation Research. Patients with untreatable angina https who received the injections of CD stem cells https in key areas of the heart had significantly fewer chest pain episodes and significantly better performance on exercise https tests than patients who got placebo https injections. Treating Angina Drugs angioplasty https and coronary artery bypass graft https CABG surgery are the main treatments for angina chest pain caused by blocked coronary arteries https About Americans have angina that persists despite available treatments. These are patients who have been on drugs and may have had multiple angioplasties or CABG surgeries AHA President Gordon Tomaselli MD tells WebMD. Their activities are severely restricted by their chest pain and right now we have little to offer them. The new treatment came from the discovery about a decade ago that CD stem cells stimulate the formation of new blood https vessels study researcher Douglas W. Losordo MD of Chicagos Northwestern University tells WebMD. Coronary artery disease https involves not only the blockage of major arteries but the death of small vessels or capillaries of the heart muscle he says. This treatment targets these small vessels that have been damaged. The stem cells have shown the ability to repair and replace them in animal models. The approach also showed promise in a pilot study involving fewer than patients. The newly reported study included patients with severe angina treated at medical centers across the country. Chest Pain Relief Study participants received one of three treatments lowdose CD injections highdose injections or placebo. Patients were given a drug for several days to increase the number of CD stem cells in the blood. Blood was collected and processed to collect the stem cells and then using a catheter threaded into the heart the researchers injected the CD cells into areas of the muscle that had been identified as oxygendeprived areas. The patients received such injections during a single catheterization procedure. Among the major findings Six months after the procedure patients treated with the stem cells had an average of seven attacks of angina a week compared to close to in the placebo group. At months the lowdose stem cell patients were having around six chest pain episodes a week compared to in the placebotreated patients. Exercise https tolerance test scores were also better in the stemcelltreated patients. The lowdose stem cell patients had improvements of seconds compared to seconds in the placebotreated patients. Patients in both active treatment portions of the study used less nitroglycerin https to treat angina attacks than patients in the placebo group but the difference was small. About one in three patients had elevations of a cardiac enzyme that is associated with heart attacks https While the elevations did not appear to be clinically significant Losordo says the researchers will continue to closely monitor cardiac enzymes https_assetscontrolled_contenthealthwisemedicaltestcardiac_enzyme_studies_medicaltest_hw.xml in patients who receive the treatment. Improvements in Quality of Life Losordo says the improvements in the stemcelltreated patients were life altering for many patients. To put it in human terms patients who might have been able to sit and watch TV without symptoms could now walk at a normal pace without chest pain and someone who could walk at a slow pace might be able to ride a bike he says. The study was funded by Illinoisbased medical device manufacturer Baxter Healthcare https which hopes to market the machine that collects the stem cells. A phase III study expected to involve around medical centers in the U.S. is in the planning stages. There is an emerging notion that our bodies even the bodies of patients with significant disease contain this natural biology that can heal Losordo says. We are just beginning to understand and exploit this preinstalled mechanism for selfrepair. Tomaselli says the study shows that the approach is both safe and feasible in patients with significant coronary disease. The results are pretty undeniable he says. The stem cell treated patients had improvements in angina frequency and improvements in exertion times. The next step is to prove the treatment is clinically useful."

"It was launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now the chameleon drug ketamine is finding new life as an unapproved treatment for depression and suicidal behavior. Clinics have opened around the United States promising instant relief with their unique doses of ketamine in IVs sprays or pills. And desperate patients are shelling out thousands of dollars for treatment often not covered by health insurance with scant evidence on longterm benefits and risks. Chicago preschool teacher Lauren Pestikas long struggled with depression and anxiety and made several suicide attempts before trying ketamine earlier this year. The price tag so far is about but its worth every dime and penny said the yearold. Pestikas said she feels much better for a few weeks after each treatment but the effects wear off and she scrambles to find a way to pay for another one. For now ketamine has not received approval from the U.S. Food and Drug Administration for treating depression though doctors can use it for that purpose. Ketamine has been around since the s and is widely used as an anesthesia drug during surgery because it doesnt suppress breathing. Compared to opioids such as morphine ketamine isnt as addictive and doesnt cause breathing problems. And some studies have shown that ketamine can ease symptoms within hours for the toughest cases. Its potential effects on depression were discovered in animal experiments in the late s and early s showing that glutamate a brain chemical messenger might play a role in depression and that drugs including ketamine that target the glutamate pathway might work as antidepressants. Conventional antidepressants like Prozac target serotonin a different chemical messenger and typically take weeks to months to kick in a lag that can cause severely depressed patients to sink deeper into despair. Ketamines potential for almost immediate if temporary relief is what makes it so exciting said Dr. Jennifer Vande Voort a Mayo Clinic psychiatrist who has used ketamine to treat depression patients since February. We dont have a lot of things that provide that kind of effect. What I worry about is that it gets so hyped up she said. The strongest studies suggest its most useful and generally safe in providing shortterm help for patients who have not benefited from antidepressants. That amounts to about onethird of the roughly million people with depression worldwide. It truly has revolutionized the field changing scientists views on how depression affects the brain and showing that rapid relief is possible said Yale University psychiatrist Dr. Gerard Sanacora who has done research for or consulted with companies seeking to develop ketaminebased drugs. But to become standard depression treatment he said much more needs to be known. Last year Sanacora coauthored an American Psychiatric Association task force review of ketamine treatment for mood disorders that noted the benefits but said major gaps remain in knowledge about longterm effectiveness and safety. Most studies have been small done in research settings and not in the real world. When delivered through an IV ketamine can cause a rapid increase in heart rate and blood pressure that could be dangerous for some patients. Ketamine also can cause hallucinations that some patients find scary. There are some very real concerns Sanacora said. We do know this drug can be abused so we have to be very careful about how this is developed. Dr. Rahul Khare an emergency medicine specialist in Chicago first learned about ketamines other potential benefits a decade ago from a depressed and anxious patient he was preparing to sedate to fix a repeat dislocated shoulder. He said Doc give me what I got last time. For about three weeks after I got it I felt so much better Khare recalled. Khare became intrigued and earlier this year began offering ketamine for severe depression at an outpatient clinic he opened a few years ago. He also joined the American Society for Ketamine Physicians formed a year ago representing about U.S. doctors nurses psychologists and others using ketamine for depression or other nonapproved uses. There are about U.S. ketamine clinics compared with about three years ago said society cofounder Dr. Megan Oxley. Khare said the burgeoning field is like a new frontier where doctors gather at meetings and compare notes. He has treated about patients with depression including Pestikas. Theyre typically desperate for relief after failing to respond to other antidepressants. Some have lost jobs and relationships because of severe depression and most find that ketamine allows them to function Khare said. Typical treatment at his clinic involves six minute sessions over about two weeks costing each. Some insurers will pay about half of that covering Khares office visit cost. Patients can receive booster treatments. They must sign a fourpage consent form that says benefits may not be longlasting lists potential side effects and in bold letters states that the treatment is not governmentapproved. At a recent session Pestikass seventh she leaned back on a reclining white examiningroom chair as a nurse hooked her up to a heart and blood pressure monitor. She grimaced as a needle was slipped into the top of her left palm. Khare reached up with a syringe to inject a small dose of ketamine into an IV bag hanging above the chair then dimmed the lights pulled the window curtains and asked if she had questions and was feeling OK. No questions just grateful Pestikas replied smiling. Pestikas listened to music on her iPhone and watched psychedelic videos. She said it was like a controlled acid trip with pleasant hallucinations. The trip ends soon after the IV is removed but Pestikas said she feels calm and relaxed the rest of the day and that the mood boost can last weeks. Studies suggest that a single IV dose of ketamine far smaller than used for sedation or partying can help many patients gain relief within about four hours and lasting nearly a week or so. Exactly how ketamine works is unclear but one idea is that by elevating glutamate levels ketamine helps nerve cells reestablish connections that were disabled by depression said ketamine expert Dr. Carlos Zarate chief of experimental therapies at the National Institute of Mental Health. A small Stanford University study published in August suggested that ketamine may help relieve depression by activating the brains opioid receptors. Janssen Pharmaceuticals and Allergan are among drug companies developing ketaminelike drugs for depression. Janssen leads the effort with its nasal spray esketamine. The company filed a new drug application in September. Meanwhile dozens of studies are underway seeking to answer some of the unknowns about ketamine including whether repeat IV treatments work better for depression and if theres a way to zero in on which patients are most likely to benefit. Until there are answers Zarate of the mental health institute said ketamine should be a lastresort treatment for depression after other methods have failed. It was launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now the chameleon drug ketamine is finding new life as an unapproved treatment for depression and suicidal behavior. Clinics have opened around the United States promising instant relief with their unique doses of ketamine in IVs sprays or pills. And desperate patients are shelling out thousands of dollars for treatment often not covered by health insurance with scant evidence on longterm benefits and risks. Chicago preschool teacher Lauren Pestikas long struggled with depression and anxiety and made several suicide attempts before trying ketamine earlier this year. The price tag so far is about but its worth every dime and penny said the yearold. Pestikas said she feels much better for a few weeks after each treatment but the effects wear off and she scrambles to find a way to pay for another one. For now ketamine has not received approval from the U.S. Food and Drug Administration for treating depression though doctors can use it for that purpose. Ketamine has been around since the s and is widely used as an anesthesia drug during surgery because it doesnt suppress breathing. Compared to opioids such as morphine ketamine isnt as addictive and doesnt cause breathing problems. And some studies have shown that ketamine can ease symptoms within hours for the toughest cases. Its potential effects on depression were discovered in animal experiments in the late s and early s showing that glutamate a brain chemical messenger might play a role in depression and that drugs including ketamine that target the glutamate pathway might work as antidepressants. Conventional antidepressants like Prozac target serotonin a different chemical messenger and typically take weeks to months to kick in a lag that can cause severely depressed patients to sink deeper into despair. Ketamines potential for almost immediate if temporary relief is what makes it so exciting said Dr. Jennifer Vande Voort a Mayo Clinic psychiatrist who has used ketamine to treat depression patients since February. We dont have a lot of things that provide that kind of effect. What I worry about is that it gets so hyped up she said. The strongest studies suggest its most useful and generally safe in providing shortterm help for patients who have not benefited from antidepressants. That amounts to about onethird of the roughly million people with depression worldwide. It truly has revolutionized the field changing scientists views on how depression affects the brain and showing that rapid relief is possible said Yale University psychiatrist Dr. Gerard Sanacora who has done research for or consulted with companies seeking to develop ketaminebased drugs. But to become standard depression treatment he said much more needs to be known. Last year Sanacora coauthored an American Psychiatric Association task force review of ketamine treatment for mood disorders that noted the benefits but said major gaps remain in knowledge about longterm effectiveness and safety. Most studies have been small done in research settings and not in the real world. When delivered through an IV ketamine can cause a rapid increase in heart rate and blood pressure that could be dangerous for some patients. Ketamine also can cause hallucinations that some patients find scary. There are some very real concerns Sanacora said. We do know this drug can be abused so we have to be very careful about how this is developed. Dr. Rahul Khare an emergency medicine specialist in Chicago first learned about ketamines other potential benefits a decade ago from a depressed and anxious patient he was preparing to sedate to fix a repeat dislocated shoulder. He said Doc give me what I got last time. For about three weeks after I got it I felt so much better Khare recalled. Khare became intrigued and earlier this year began offering ketamine for severe depression at an outpatient clinic he opened a few years ago. He also joined the American Society for Ketamine Physicians formed a year ago representing about U.S. doctors nurses psychologists and others using ketamine for depression or other nonapproved uses. There are about U.S. ketamine clinics compared with about three years ago said society cofounder Dr. Megan Oxley. Khare said the burgeoning field is like a new frontier where doctors gather at meetings and compare notes. He has treated about patients with depression including Pestikas. Theyre typically desperate for relief after failing to respond to other antidepressants. Some have lost jobs and relationships because of severe depression and most find that ketamine allows them to function Khare said. Typical treatment at his clinic involves six minute sessions over about two weeks costing each. Some insurers will pay about half of that covering Khares office visit cost. Patients can receive booster treatments. They must sign a fourpage consent form that says benefits may not be longlasting lists potential side effects and in bold letters states that the treatment is not governmentapproved. At a recent session Pestikass seventh she leaned back on a reclining white examiningroom chair as a nurse hooked her up to a heart and blood pressure monitor. She grimaced as a needle was slipped into the top of her left palm. Khare reached up with a syringe to inject a small dose of ketamine into an IV bag hanging above the chair then dimmed the lights pulled the window curtains and asked if she had questions and was feeling OK. No questions just grateful Pestikas replied smiling. Pestikas listened to music on her iPhone and watched psychedelic videos. She said it was like a controlled acid trip with pleasant hallucinations. The trip ends soon after the IV is removed but Pestikas said she feels calm and relaxed the rest of the day and that the mood boost can last weeks. Studies suggest that a single IV dose of ketamine far smaller than used for sedation or partying can help many patients gain relief within about four hours and lasting nearly a week or so. Exactly how ketamine works is unclear but one idea is that by elevating glutamate levels ketamine helps nerve cells reestablish connections that were disabled by depression said ketamine expert Dr. Carlos Zarate chief of experimental therapies at the National Institute of Mental Health. A small Stanford University study published in August suggested that ketamine may help relieve depression by activating the brains opioid receptors. Janssen Pharmaceuticals and Allergan are among drug companies developing ketaminelike drugs for depression. Janssen leads the effort with its nasal spray esketamine. The company filed a new drug application in September. Meanwhile dozens of studies are underway seeking to answer some of the unknowns about ketamine including whether repeat IV treatments work better for depression and if theres a way to zero in on which patients are most likely to benefit. Until there are answers Zarate of the mental health institute said ketamine should be a lastresort treatment for depression after other methods have failed."

"A simple safe relatively inexpensive hormone treatment might help some highrisk pregnant women carry their babies longer a new study http suggests while improving the outlook for their infants. Such a treatment has been long sought. Even better the newest one would appear unlikely to cost a dose unless drug makers are slow learners. Federal researchers working with colleagues at medical centers found that administering vaginal progesterone to women with a short cervix a risk factor for premature delivery cuts the rate of delivering before weeks by . The reduction applies only to women with a short cervix between centimeter and centimeters not for women at high risk for other reasons. But for these women few medications have been found effective at keeping a baby in the womb longer. Physicians led by the National Institute of Child Health and Human Development in Bethesda Md. assigned women with a short cervix to receive daily applications of either a progesterone gel or a placebo gel between the th and rd weeks of pregnancy. Fewer women who got the progesterone treatment delivered early. versus . in the placebo group the team reported online httponlinelibrary.wiley.comdoi.uog.pdf in the journal Ultrasound in Obstetrics and Gynecology. Further there were indications the hormone might help the babies too. Fewer babies born to mothers given progesterone had respiratory distress syndrome a lung disorder common to premature infants versus .. The data set isnt very large of women given progesterone delivered early compared with of women given a placebo. And of course the trial was funded by the maker of the progesterone gel to be marketed as Prochieve. But giving progesterone gel to women with short cervical length would appear to prevent one premature birth and a progesterone gel the company already sells Crinone is FDA approved for women in some fertility treatments. The researchers used about worth of the strength of Crinone in each dose. Thus the findings are promising especially when few drugs can keep a pregnant woman from delivering early. One new drug httparticles.latimes.comfebhealthlahefdamakena also progesteronebased is marketed for women who have already had a spontaneous preterm birth. That drug Makena http was the subject of considerable controversy recently after its manufacturer boosted the price from per dose to per dose before finally lowering it to . Makena an injectable is administered weekly. RELATED Drug maker lowers price of Makena pregnancy drug to per dose http If the progesterone gel is as effective as the study suggests women would likely find the price tolerable. But probably not at a dose."

"Each year nearly three times as many Americans die from suicide as from homicide. More Americans kill themselves than die from breast cancer. As Dr.Thomas Insel http longtime head of the National Institute of Mental Health prepared to step down from his job in October he cited the lack of progress in reducing the number of suicides as his biggest disappointment. While the homicide rate in the U.S. has dropped percent since the early s the suicide rate is higher than it was a decade ago. That to me is unacceptable Insel says. It hasnt been for lack of trying. The U.S. has a national suicide hotline http and there are suicide prevention programs in every state. Theres screening educational programs and midnight walks to raise awareness. Yet over the past decade or so the national suicide rate has increased. In the suicide rate was . per people. In it was .. An effort that began in Detroit in to treat the most common cause of suicide depression is offering hope. With a relentless focus on finding and treating people with depression the Henry Ford Health System http has cut the suicide rate among the people in its insurance plan dramatically. The story of the health systems success is a story of persistence confidence hope and a strict adherence to a very specific approach. That approach saved the life of a woman who prefers to be known only by her first name Lynn. She agreed to share her medical history on the condition that we not use her full name to protect her privacy. Lynn whos now in her mids has had bipolar disorder http also known as manicdepressive illness for nearly years. The depressive part of her illness is like the pain of having a cancer she says. About years ago she started getting irresistible urges to take her own life and she started making serious attempts at times almost monthly. When I was in the depths of depression I was being pulled and sucked into this black tunnel she says. I was desperately trying to grab onto something to stop from being sucked in. Sometimes she couldnt find anything to hang on to. Those are the times when I finally let go and attempted suicide she says. The program that saved Lynn almost didnt get off the ground. Fifteen years ago suicide prevention care at Henry Ford like in many places was mostly reactive. When patients came in talking about suicide health providers took notice. But little was done to find people before they reached that point. Some of the health providers in the psychiatric division decided they could do better. So they applied to a foundation for a grant to provide something they called perfect depression care for the patients in the health system. The goal zero suicides. The mental health division failed to win the grant but the health system went ahead with the proposed changes anyway. The plan it developed is intensive and thorough an almost cookbook approach. Primary care doctors screen every patient with two questions How often have you felt down in the past two weeks And how often have you felt little pleasure in doing things A high score leads to more questions about sleep disturbances changes in appetite thoughts of hurting oneself. All patients are questioned on every visit. If the health providers recognize a mental health problem patients are assigned to appropriate care cognitive behavioral therapy drugs group counseling or hospitalization if necessary. On each patients medical record providers have to attest to having done the screening and they record plans for any needed care. Therapists involve patients families and ask them to remove guns or other means of suicide from their homes. Clerks are trained to make sure that patients who need followup care dont leave without an appointment. Patients themselves come up with safety plans. Lynn has two copies one by her nightstand and one in her kitchen. Each lists things she can do when she feels depression coming on. She could sit on her balcony or do some drawing or painting. The list includes her therapists phone numbers. And theres a reminder that the feeling will pass it has before. Before the zero suicide plan went into effect says psychiatrist Doree Ann Espiritu http acting head of the zero suicide program at Henry Ford you might make a contract with a patient where the patient agrees not to commit suicide. Studies show it doesnt work very well she says. Today providers are trained to be comfortable asking their patients about suicidal thoughts. There is a fear among clinicians that if you ask questions about suicide you are giving the patient an idea that this could be an option says Espiritu and if you ask about guns or pills that you are giving them some hints on how they can carry out a plan. The Henry Ford therapists are trained to break that barrier. For Lynn the key was persistence her therapists and her own. I recall one time with my psychiatrist who kept trying to encourage me and help me find ways of coping and I can remember saying I dont believe theres hope I dont see it I dont feel it I need you to hold on to that for me because its not there she recalls. Her therapists never gave up. There is no question that the message I got from Day is that they knew they could help me and they would help me Lynn says. Over the years shes been in group therapy day treatment and when things got bad the emergency room. The Henry Ford approach is catching on. A stream of visitors from U.S. health insurers and from the United Kingdom have made site visits. The Suicide Prevention Resource Center http has run two zero suicide training academies for teams from health care systems based on the Henry Ford principles. Other health systems have adapted the plan including Group Health Cooperative https Seattle and the behavioral health provider Centerstone https in Tennessee. Espiritu started work at Henry Ford just as the program was starting and she remembers the initial staff meetings There was a lot of How can you do this How can you aim for zero How can you expect your clinicians to be perfect and follow this protocol Some people didnt think it could be done she says or even attempted. Still the health system went ahead and the rewards were nearly immediate. Henry Ford epidemiologist Brian Ahmedani http the numbers. In for those being actively treated for a mental health problem or substance abuse we had a rate of zero per hundred thousand he says. Its crept up to per per year but thats still percent lower than it was when the program began. The rate is five per in the organizations general population which is well below the national average and has remained steady despite an increasing rate of suicide statewide. Theres reason to think a fullbore effort to treat depression could reduce health costs because untreated depression is associated with higher medical bills for chronic illnesses such as diabetes and hypertension. But there are training costs involved and the Henry Ford system has had to keep its staffing up to be able to provide care for people who need it. Officials at Henry Ford say they havent analyzed the costs. But Centerstone https has. The behavioral health provider in Nashville implemented the Henry Ford approach for nearly patients whod already made a suicide attempt. Reductions in emergency room visits and hospitalizations over the course of a year resulted in savings of more than . Why push for zero rather than just a reduction Because if you say were OK with five a year one of those might be your brother or your friend says Espiritu. We aim for zero because it reminds all of us of what we would want for ourselves. Maybe it is not possible she says. But it is a goal. And as for Lynn she doesnt consider herself cured. She says with the treatment shes received at Henry Ford shes learned to live even thrive with bipolar disease. And shes alive. That she says makes her a big success story."

"At it just didnt make sense that Daniel Sheiner was exhausted literally from the moment he woke up. It didnt get any better over the course of the day and I knew that was not normal Sheiner says. Sheiner is a software designer and programmer. His job suffered as a result of his fatigue. I would miss conversations Sheiner says. I would ask a question that had already been answered. Sheiner suspected he had sleep apnea because it ran in his family. But he was not overweight which is the biggest risk factor for the disorder some percent to percent of patients diagnosed with apnea have a body mass index or BMI over . A sleep study confirmed Sheiner had one of the worst cases of apnea his doctors had ever seen. After trying a number of different treatments his doctors finally tried a surgery using robots to treat his stubborn apnea with positive results. Gasping For Breath According to Erica Thaler an ear nose and throat surgeon at the Hospital of the University of Pennsylvania Sheiners sleep study found that he woke up about times every hour. That meant Sheiner stopped breathing for at least seconds about two times every minute. Article continues after this message from our sponsor Sleep apnea is a chronic and common sleep disorder. People with this condition stop breathing while sleeping. Like Sheiner they often find themselves suddenly and repeatedly gasping for breath during the night. Their airway is clogged sometimes because their tonsils and tonsilar tissue in the back of their throat are enlarged. This was exactly the case for Sheiner. Daniels obstruction was both at the level of the soft palate and at the back of the tongue Thaler says. He had very large tonsils but his tonsil tissue was also enlarged in the palate area and also at the back of his tongue. Sheiner was put on a nighttime breathing machine. In bed he wore a face mask which was connected to a tube that was connected to a device that pumped air into his nose and mouth. The Continuous Positive Airway Pressure machine or CPAP as it is often referred to works for about half of all patients who try it. It can be cumbersome Thaler says. But Sheiner was extremely committed to trying it. In fact he tried a number of different types of machines but none of them worked. Handing Surgery Off To Robots So Thaler suggested a type of robotic surgery currently used to remove cancerous tumors at the back of the throat. Thaler was starting to perform it on sleep apnea patients to remove tonsils and excess tissue. What the robot allows you to do is get into a small confined space without using hands Thaler says. Human hands are huge and robot hands are tiny and yet they can do exactly the same thing if you control them remotely. So about a year ago Thaler performed surgery on Sheiner removing both his tonsils and excess tissue. Sheiner is one of only about a halfdozen patients to have this robotic surgery for apnea. After surgery Sheiner says it was a whole new life. He had energy an ability to focus and get things done. I find myself solving problems much more quickly and more confidently. Hes exercising at the gym three times a week lifting weights. He is also starting to experiment with recipes and cooking something he had absolutely no energy or interest in doing before the surgery. Surgery Not For Everyone The surgery Sheiner had isnt right for everyone. Rashmi N. Aurora is a sleep specialist at Mount Sinai School of Medicine in New York. She is also chairwoman of the Standards of Practice Committee of the American Academy of Sleep Medicine http I wouldnt send a middleage obese man for surgery as their first option Aurora says. I would say lets lose the weight lets use CPAP and see a nutritionist lets avoid the alcohol and lets see how you do. The apnea can probably be taken care of with these noninvasive techniques she says and invasive surgery can be avoided. But when she sees a young thin person with severe apnea Aurora says surgery might be the answer. The upper airway starts with the nose and mouth and runs down to the vocal chords so theres a lot of room for obstruction to occur Aurora says. Some patients may require surgery to remove the uvula or the tonsils or excess tissue or all of them she says. Then theres surgery to remove blockage in the nasal passage. Oftentimes Aurora says patients need a series of surgeries to completely treat apnea. And even then success rates arent high theyre effective only to percent of the time. The only surgery proved effective more than percent of the time is a significant and highly invasive surgery. Maxillomandibular advancement or MMA involves literally slicing the jaw in half and moving it forward in order to widen the patients airway. For patients with recessed chins small jaws and airways narrowed by facial structure this might be the surgery for them. But it can take nearly a year to recover and many patients opt not to have it. The new CPAP machines are more sophisticated Aurora says. Theyre less cumbersome less noisy and can actually sense the magnitude of blockage and adjust air pressure being blown into the nose or mouth she says. Noninvasive measures are always the first lines of defense she says."

"Theres another type of prescription drugs besides opioid painkillers thats involved in thousands of drug overdose deaths in the US every year. The drugs are benzodiazepines which are widely known by their brand names Xanax and Valium and commonly prescribed to help treat anxiety. These drugs were involved in nearly overdose deaths in according to federal data https But theres a catch Such overdoses seem to be very closely tied to the opioid epidemic http with the majority of benzodiazepine overdose deaths involving both benzodiazepines and opioids. A new study http published in BMJ looked at just how much the concurrent use of these two drugs increases the risk of overdose versus the risk of only using opioids. Drawing on a huge sample of nearly patients who were continuously enrolled in private health insurance plans from and researchers compared those who were prescribed just opioids versus those who were prescribed both and what their additional risk of an emergency room visit or inpatient admission was in the period they were prescribed both. The study found that among all opioid users concurrent use of benzodiazepines more than doubled the risk of an emergency room or inpatient visit for a drug overdose. The study also found that eliminating concurrent benzodiazepine and opioid use could reduce the risk for an opioid overdoserelated emergency room or inpatient visit by percent. If that reduced risk applies to overdose deaths as well eliminating concurrent opioid and benzodiazepine use could have prevented up to opioid painkillerrelated overdose deaths in . Keith Humphreys a drug policy expert at Stanford University and one of the authors of the study said this reveals an underappreciated policy lever for reducing drug overdoses making sure patients prescribed to opioids arent also prescribed to benzodiazepines and vice versa. Even if we didnt change opioid prescribing at all the data here suggest that we could cut overdoses dramatically just by getting prescribers to not put people on a benzodiazepine at the same time Humphreys said. Yet the study suggests the opposite has happened. From to coprescriptions to opioids and benzodiazepines among the studied pool of patients increased from percent to percent a nearly percent jump. For some patients eliminating these coprescriptions could involve some tough tradeoffs. If someone genuinely suffers from pain and anxiety doctors and patients will need to work out which condition is more important to treat and which one can be treated with alternatives to avoid a potentially deadly overdose. Hopefully while keeping in mind that theres no httpannals.orgarticle.aspxarticleID good http scientific http evidence http that opioids can treat chronic pain so opioids arent the right treatment for chronic pain in the first place. There are some caveats to the study. For one emergency room visits and inpatient admissions for opioid overdoses likely arent a perfect onetoone proxy for overdoses that didnt involve a trip to a doctor. The study also only looked at legally prescribed opioid painkillers and benzodiazepines missing the effects of concurrent use of illegally obtained pills or drugs. And since the research relied on patients who were continuously insured throughout the study period its possible the findings dont exactly apply to people with spottier coverage. Although sensitivity analyses in the study for people who had lapses in insurance produced similar results. Finally since the study looked at correlation not causation its possible that it missed some other factor driving up overdose deaths among concurrent benzodiazepine and opioid users perhaps for whatever reason these users may be more likely to misuse their drugs. Still its well established https that benzodiazepine and opioids compound each others overdose risk. So its not really controversial to conclude that simultaneously using opioids and benzodiazepines dramatically increases the risk of drug overdose or conversely that stopping the concurrent use of these two drugs could reduce the risk of overdose. Given that the opioid epidemic has quickly turned into the deadliest drug crisis in US history http its important and potentially lifesaving for doctors and policymakers to at least consider the studys findings. For more on the opioid epidemic read Voxs indepth explainer http the abridged explainer http or the maps and charts explainer http"

"A fiveyear study shows that Stereotactic Body Radiation Therapy SBRT to treat prostate cancer offers a higher cure rate than more traditional approaches according to researchers at UT Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center. The study the first trial to publish fiveyear results from SBRT treatment for prostate cancer found a . percent cure rate with SBRT a noninvasive form of radiation treatment that involves highdose radiation beams entering the body through various angles and intersecting at the desired target. It is a stateoftheart technology that allows for a concentrated dose to reach the tumor while limiting the radiation dose to surrounding healthy tissue. The high cure rate is striking when compared to the reported fiveyear cure rates from other approaches like surgery or conventional radiation which range between to percent while the side effects of this treatment are comparable to other types of treatment said Dr. Raquibul Hannan Assistant Professor of Radiation Oncology and lead author for the study. What we now have is a more potent and effective form of completely noninvasive treatment for prostate cancer conveniently completed in five treatments. Conventional treatment options for early stage prostate cancer include Prostatectomy the surgical removal of the prostate gland which can be done with minimally invasive techniques and robotic assistance Brachytherapy in which doctors implant numerous small radioactive seeds about the size of a grain of rice into the prostate gland using multiple large needles inserted through the skin in the operating room. Once implanted the seeds release their radioactivity directly into the prostate gland and External beam radiation which involves to treatments administered over two or more months five days a week. The current form of radiation is treatments given over nine weeks. In contrast the SBRT therapy we used allows the delivery of highly focused radiation in only five treatments allowing patients to return to their normal lives more quickly said senior author Dr. Robert Timmerman Director of the Annette Simmons Stereotactic Treatment Center at UT Southwestern and Professor and Vice Chairman of the Department of Radiation Oncology. SBRT is both more convenient and has increased potency. UT Southwestern served as the lead site for the multiinstitutional clinical trial which involved firsttime prostate cancer patients diagnosed with stage I or stage II low and intermediate risk prostate cancer. A total of patients were treated prospectively and followed for five years with only one patient experiencing a recurrence of his cancer. The findings are published in the European Journal of Cancer. Terry Martin of McKinney Texas about an hour outside Dallas said the fewer number of treatments was a compelling advantage when he was evaluating treatment options. I live minutes away from UT Southwestern. The difference between being treated five times versus times is enormous said Mr. Martin a retired airline pilot. I felt that I was back to normal just days after finishing treatment. In addition to shorter treatment times researchers found that side effects were not necessarily different compared to other forms of prostate cancer treatment. In the short term the side effects of SBRT can include urinary issues urgency frequency and burning and rectal irritation which are often temporary and reverse within four weeks of treatment. Researchers found a small risk of longerterm urinary and rectal complications which is also comparable to conventional treatments. Decrease in erectile function was seen in percent of patients fewer than with conventional radiation or surgery said Dr. Hannan. To reduce the side effects associated with SBRT current clinical trials at UTSW are using a unique and biodegradable rectal spacer gel to protect the rectum. UTSW is currently the only accredited site in Texas at which this spacer gel can be used. Other clinical trials at the UTSW Department of Radiation Oncology are seeking to expand the application of SBRT to highrisk Stage III prostate cancer patients. Our hope is that the high potency of this form of treatment will significantly improve treatment of these patients says Dr. Hannan the principal investigator of the highrisk prostate SBRT trial. UT Southwestern has been a leader in pioneering use of SBRT. Dr. Timmerman Director of ImageGuided Stereotactic Radiation Therapy Medical Director of Radiation Oncology and holder of the Effie Marie Cain Distinguished Chair in Cancer Therapy Research has served as the lead investigator in several national trials designed to evaluate the efficacy and safety of SBRT to treat other types of cancer including cancer in the lung liver and spine. A range of clinical trials of SBRT therapy are under way at Simmons Cancer Center including new investigations evaluating use of SBRT for cancers in the breast and larynx. Since UT Southwestern has trained more than physicians and peers interested in implementing SBRT in their clinical practice. Simmons Cancer Centers arsenal of stereotactic radiotherapy technology includes the cuttingedge Gamma Knife CyberKnife Agility Vero SBRT and TrueBeam technologies. The SBRT study for prostate cancer was supported by a grant from the U.S. Department of Defense. Additional UTSW researchers involved in the study include Dr. Yair Lotan Professor of Urology and holder of the Helen J. and Robert S. Strauss Professorship in Urology and Dr. XianJin Xie Professor of Clinical Science. The Harold C. Simmons Comprehensive Cancer Center is the only NCIdesignated Comprehensive Cancer Center in North Texas and one of just NCIdesignated Comprehensive Cancer Centers in the nation. The Simmons Cancer Center includes major cancer care programs with a focus on treating the whole patient with innovative treatments while fostering groundbreaking basic research that has the potential to improve patient care and prevention of cancer worldwide. In addition the Centers education and training programs support and develop the next generation of cancer researchers and clinicians. The Simmons Cancer Center is among only U.S. cancer research centers and the only cancer center in North Texas to be named a National Clinical Trials Network Lead Academic Participating Site a prestigious designation by the NCI designed to bolster clinical cancer research for adults and to provide patients access to cancer research trials sponsored by the NCI where promising new drugs often are tested. About UT Southwestern Medical Center UT Southwestern one of the premier academic medical centers in the nation integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty has included six who have been awarded Nobel Prizes since . The faculty of almost is responsible for groundbreaking medical advances and is committed to translating sciencedriven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in about specialties to more than hospitalized patients and oversee approximately . million outpatient visits a year. This news release is available on our home page at http To automatically receive news releases from UT Southwestern via email subscribe at http"

"Researchers are hoping that by using a common tool for measuring of brain activity in a new way they may be one step closer to identifying whether a child is a greater risk for autism. We havent diagnosed autism at this point says William Bosl Ph.D. lead author and a research scientist at Childrens Hospital Boston http But he says by using an electroencephalogram httpkidshealth.orgparentgeneralsickeeg.html and new sophisticated computer programs to analyze the EEGs he and his coauthors were able to correctly identify with accuracy which babies were at higher risk for autism and which were not. Scientists have known for quite some time now that the earlier a child with autism gets therapy the easier it is to improve language and behavioral skills. In the American Academy of Pediatrics http that all children be screened for autism at the ages of months and months. Here researchers are trying to find markers for autism before a child begins showing signs of autism. In a new study published Tuesday in the journal BMC Medicine scientists studied infants. babies had a brother or sister with known autism which means they themselves are at an increased risk for the neurodevelopmental disorder that affects about one in children according to the Centers for Disease Control and Prevention http The sibling of a child with a confirmed diagnosis of autism has a in chance of also developing the disorder. These infant siblings were compared with infants with no known family history of autism. The babies were given EEGs at and months of age. Researchers strapped a net of electrodes all over a babys head while it was sitting in its moms lap and a research assistant was blowing bubbles to hold the childs attention. The electrodes measured actual firings of neurons. The EEG technique is much easier to use because the baby can be awake and moving and wiggling around says Dr. Geraldine Dawson chief science officer for the advocacy group Autism Speaks http which partially funded this research. Other brain imaging technologies like magnetic resonance imaging would require a baby to be asleep or sedated because they have to be completely still while the test is being done. Nobody wants to sedate a healthy infant says Dawson. Bosl explains that the new computer algorithms that he developed were able to analyze results of the EEG much better than in the past. He said that judging by the differences in brain activity he and his colleagues could detect which babies were in the highrisk group. They say they were nearly accurate when the boys were months old. They were most accurate with baby girls at age months. Overall the biggest differences in brain activity were seen at months which is much earlier than when a child typically shows behavioral problems associated with autism. The differences in brain activity were smaller as the babies got older. Doctors and scientists not connected to the study are intrigued by the results but caution that this is very early research and not something concerned parents can be looking for as a screening tool for their babies any time soon. Sarah Paterson Ph.D. is the director of the neuroimaging lab at the Center for Autism Research at Childrens Hospital of Philadelphia http She is also looking for early signs of autism as part of the Infant Brain Imaging Study http but her work focuses on differences in brain structure. Paterson says that if the results out of Boston can be confirmed Its very exciting because finding an early sign for autism is really the holy grail. But she cautions that a lot more work needs to be done. This study needs to be replicated by their lab and independent scientists she says. Dr. Max Wiznitzer says the researchers have found a really fascinating technique that offers a different way to look at the brain. Wiznitzer a pediatric neurologist at Rainbow Babies Childrens Hospital http Cleveland Ohio notes that what the study cant tell us is what the differences in brain activity between the two groups of babies actually mean. He too is hopeful that further research will provide more concrete information. Bosl says the first children enrolled in his study are now at and years old which is the age when autism usually is diagnosed. This will now allow the researchers to evaluate them for autism and then look back at the brain activity patterns of the children who do fit the clinical criteria for autism. Bosl acknowledges that if this is very early research but he believes if the results are confirmed it may lead to a safe and inexpensive way to detect autism which would allow intervention before any autistic behaviors appear. Itll change the field if this works says Bosl. He hopes to expand the number of babies in his study to . The only thing slowing us down right now is funding."

"Preliminary findings suggest a drug used to treat another disease might also reduce painful flareups in gout patients starting new medication regimens. In a new study the proteininhibitor drug rilonacept Arcalyst appeared to markedly lower the risk of gout flareups during the first few months of treatments aimed at lowering uric acid levels. While effective in lowering the risk for gout attacks in the longterm uric acidlowering treatment can initially boost the risk for flareups as it breaks up and releases the uric acid crystal deposits at the source. To reduce deposits of crystals in the joints we advise patients to initiate treatment with medications that lower levels of uric acid in the blood study author Dr. H. Ralph Schumacher Jr. a professor of medicine at the University of Pennsylvania School of Medicine said in a journal news release. Gout a debilitating and painful form of inflammatory arthritis now affects upwards of . million Americans according to the release. Flareups which involve excruciating joint pain redness swelling and warmth can last days or weeks. The researchers wanted to learn if rilonacept could lower this shortterm risk for by neutralizing a specific target protein interleukin or IL before it initiates inflammation. They looked at gout patients in U.S. study centers who had a history of gout flareups and high levels of uric acid. All were placed on a chronic uricacid lowering regimen of the standard drug allopurinol. About half were also given an initial doubledose injection of rilonacept milligrams followed by a single dose for weeks. The other half received sugar pills. Rilonacept patients were less likely to have flareups with percent experiencing flareups threemonths into the study compared with percent among the nonrilonacept group the researchers found. Welltolerated drugs that reduce the risk of gout flares when initiating uricacid lowering therapy could make patients more likely to continue important longterm treatments that control gout Schumacher said in the release. And this trial provides wellcontrolled evidence that this IL blocker is effective in preventing acute gout flares in this setting he added. Rilonacept appears safe and well tolerated and could increase patient adherence to longterm uratelowering therapy. The study appeared online Jan. in the journal Arthritis Rheumatism. Dr. Michael A. Becker a professor emeritus of medicine at the University of Chicago described the findings as very promising. However he cautioned that the high cost of rilonacept will most likely curtail its use. This is a very expensive drug he said. And insurance will be an issue. So I think you will have to carefully justify its use and define the universe of patients who are likely to be treated with it. But there are a number of patients who cant take a less expensive alternative such as nonsteroidal antiinflammatory drugs because of their kidney function or ulcer disease Becker noted. So for this population of patients who cant tolerate cheaper medications rilonacept may be a necessary indication. More information For more on gout visit the U.S. National Library of Medicine http SOURCE Michael A. Becker professor emeritus medicine University of Chicago Arthritis Rheumatism news release Jan."

"A new analysis published today in JAMA Cardiology has found that timely and broad adoption of Entresto sacubitrilvalsartan by all eligible heart failure patients with reduced ejection fraction HFrEF could prevent or postpone more than deaths each year in the US alone. This analysis based on an application of the results of PARADIGMHF to published heart failure statistics is the first to quantify the possible impact of Entrestos potential benefit in reducing death. Heart failure is a chronic condition that contributes to more than deaths in the US every year. About half of people with heart failure have HFrEF. This new analysis estimates that as many as deaths in HFrEF patients annually could be prevented or postponed with optimal use of Entresto with sensitivity analyses demonstrating a range of to . Further the study suggests that delaying routine use of Entresto in clinical practice could have a substantial negative effect on patients given the expected riskbenefit profile as it could result in failure to prevent tens of thousands of deaths. These findings demonstrate the significant survival benefits Entresto could offer to those living with HFrEF if patients in the group defined by the authors were given access to treatment. The study authors stated that nearly of HFrEF patients . million people may be candidates for treatment with Entresto. Heart failure is a lifethreatening condition and despite available medicines about half of patients diagnosed with heart failure die within years. According to the study authors these findings may substantially impact the national health of the HFrEF population offering significant clinical benefit in preventing or postponing death when applied in clinical practice. This expert analysis adds to the already compelling case for the treatment of heart failure patients with reduced ejection fraction with Entresto said Fabrice Chouraqui president of Novartis Pharmaceuticals Corporation. In addition to survival benefits the study also recognizes other treatment effects of Entresto particularly in reducing HF hospitalizations. Coupled with the recent Class I recommendation the strongest endorsement in the focused update to the US HF Guideline these findings underscore the potential of Entresto as a standard therapy for chronic HFrEF patients. In a separate analysis published in the same issue of JAMA Cardiology researchers used data from the PARADIGMHF trial to model the health consequences and costeffectiveness of Entresto over a year time period. They compared Entresto to the ACEinhibitor enalapril and found Entresto was associated with more than a year longer average survival time and that it was costeffective compared to enalapril when these medications were used with other standard of care therapies. For every patients treated with Entresto vs. enalapril potentially . HF hospital admissions could be averted per each year alive in the model. In addition Entresto increased life expectancy at an incremental costeffectiveness ratio consistent with other highvalue widely accepted cardiovascular interventions such as implantable cardioverter defibrillators ICDs and cholesterollowering statins before they became generic. About Heart Failure Heart failure is a debilitating and lifethreatening condition which impacts nearly million Americans and is the leading cause of hospitalization among Americans over the age of . About half of people with heart failure have heart failure with reduced ejection fraction HFrEF. Reduced ejection fraction means the heart does not contract with enough force so less blood is pumped out. Heart failure presents a major and growing healtheconomic burden that currently exceeds billion in the United States which accounts for both direct and indirect costs. About Entresto Entresto is a twiceaday medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems Natriuretic Peptide system while simultaneously inhibiting the harmful effects of the overactive reninangiotensinaldosterone system RAAS. Other heart failure medicines only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker ARB valsartan. Entresto is indicated in the US to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure NYHA Class IIIV and reduced ejection fraction. Entresto is usually administered in conjunction with other heart failure therapies in place of an Angiotensin Converting Enzyme ACE inhibitor or an angiotensin II receptor blocker ARB. Entresto filmcoated tablets are available in three dosage strengths mg mg and mg sacubitrilvalsartan. These doses are referred to as mg mg and mg in the clinical trial literature including the New England Journal of Medicine publication of the results of PARADIGMHF. The target treatment dose of Entresto is mg twice daily. Novartis is committed to providing patients with affordable access and resources through Entresto Central. For more information please call ENTRESTO or visit http Please visit http for Entresto full Prescribing Information. IMPORTANT SAFETY INFORMATION Entresto can harm or cause death to an unborn baby. Patients should talk to their doctor about other ways to treat heart failure if they plan to become pregnant. If a patient gets pregnant while taking Entresto she should tell her doctor right away. Patients are not to take Entresto if they are allergic to sacubitril or valsartan or any of the ingredients in Entresto have had an allergic reaction including swelling of the face lips tongue throat or trouble breathing while taking a type of medicine called angiotensinconverting enzyme ACE inhibitor or angiotensin II receptor blocker ARB or take an ACE inhibitor medicine. Patients are not to take Entresto for at least hours before or after they take an ACE inhibitor medicine. Patients should talk with their doctor or pharmacist before taking Entresto if they are not sure if they take an ACE inhibitor medicine. Patients are not to take Entresto if they have diabetes and take a medicine that contains aliskiren. Before they take Entresto patients should tell their doctor about all of their medical conditions including if they have kidney or liver problems are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. Patients should either take Entresto or breastfeed. They should not do both. Patients should tell their doctor about all the medicines they take including prescription and overthecounter medicines vitamins and herbal supplements. They should especially tell their doctor if they take potassium supplements or a salt substitute nonsteroidal antiinflammatory drugs NSAIDs lithium or other medicines for high blood pressure or heart problems such as an ACE inhibitor ARB or aliskiren. Entresto may cause serious side effects including serious allergic reactions causing swelling of the face lips tongue and throat angioedema that may cause trouble breathing and death. Patients are to get emergency medical help right away if they have symptoms of angioedema or trouble breathing. Patients are not to take Entresto again if they have had angioedema while taking Entresto. People who are black or who have had angioedema may have a higher risk of having angioedema if they take Entresto. Entresto may cause low blood pressure hypotension. Patients are to call their doctor if they become dizzy or lightheaded or they develop extreme fatigue. Entresto may cause kidney problems or an increased amount of potassium in the blood. The most common side effects were low blood pressure high potassium cough dizziness and kidney problems. Please see full Prescribing Information including Boxed WARNING available at http Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit http or call FDA. Disclaimer The foregoing release contains forwardlooking statements that can be identified by words such as could potential call for accelerate possible suggests expected may compelling endorsement potentially growing committed or similar terms or by express or implied discussions regarding potential new indications or labeling for Entresto or regarding potential future revenues from Entresto. You should not place undue reliance on these statements. Such forwardlooking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect actual results may vary materially from those set forth in the forwardlooking statements. There can be no guarantee that Entresto will be submitted or approved for any additional indications or labeling in any market or at any particular time. Nor can there be any guarantee that Entresto will be commercially successful in the future. In particular managements expectations regarding Entresto could be affected by among other things the uncertainties inherent in research and development including unexpected clinical trial results and additional analysis of existing clinical data unexpected regulatory actions or delays or government regulation generally the companys ability to obtain or maintain proprietary intellectual property protection general economic and industry conditions global trends toward health care cost containment including ongoing pricing pressures unexpected safety quality or manufacturing issues and other risks and factors referred to in Novartis AGs current Form F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forwardlooking statements contained in this press release as a result of new information future events or otherwise. About Novartis Novartis Pharmaceuticals Corporation researches develops manufactures and markets innovative medicines aimed at improving patients lives. We offer a broad range of medicines for cancer cardiovascular disease endocrine disease inflammatory disease infectious disease neurological disease organ transplantation respiratory disease eye and ear care and skin conditions. The companys mission is to improve peoples lives by pioneering novel healthcare solutions. Located in East Hanover NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel Switzerland Novartis offers a diversified portfolio to best meet these needs innovative medicines eye care and costsaving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In the Group achieved net sales of USD . billion while RD throughout the Group amounted to approximately USD . billion USD . billion excluding impairment and amortization charges. Novartis Group companies employ approximately fulltimeequivalent associates. Novartis products are available in more than countries around the world. For more information please visit http Novartis is on Twitter. Sign up to follow Novartis at httptwitter.comnovartis. References . Fonarow GC Hernandez AF Solomon SD et al. Potential Mortality Reduction with Optimal Implementation of Angiotensin Receptor Neprilysin Inhibitor Therapy in Heart Failure. JAMA Cardiol. . doi.jamacardio.. . Yancy CW Jessup M Bozkurt B Butler J Casey Jr DE Colvin MM Drazner MH Filippatos G Fonarow GC Givertz MM Hollenberg SM Lindenfeld J Masoudi FA McBride PE Peterson PN Stevenson LW Westlake C ACCAHAHFSA Focused Update on New Pharmacological Therapy for Heart Failure An Update of the ACCFAHA Guideline for the Management of Heart Failure httpscontent.onlinejacc.orgarticle.aspxarticleid Journal of the American College of Cardiology doi .j.jacc.... . Gaziano TA Fonarow GC et al. CostEffectiveness Analysis of SacubitrilValsartan versus Enalapril in Heart Failure Patients with Reduced Ejection Fraction in the United States. JAMA Cardiol. . doi.jamacardio.. . Mozaffarian D Benjamin EJ Go AS et al. Heart Disease and Stroke Statistics Update A report from the American Heart Association. Circulation. ee. doi .CIR.. . Owan TE Hodge DO Herges RM et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. . . Roger VL Weston SA Redfield MM et al. Trends in heart failure incidence and survival communitybased population. JAMA. . Levy D Kenchaiah S Larson MG et al. Long term trends in the incidence and survival with heart failure. N Engl J Med. . . Weir LM Pfuntner A Maeda J et al. HCUP facts and figures statistics on hospitalbased care in the United States . Rockville MD Agency for Healthcare Research and Quality . . Ejection Fraction Heart Failure Measurement. American Heart Association Website.http_UCM__Article.jsp. Published March . Accessed March . . Heidenreich PA Albert NM Allen LA et al. Forecasting the impact of heart failure in the United States a policy statement from the American Heart Association. Circ Heart Fail. . . Entresto Prescribing Information. . Yancy CW Jessup M Bozkurt B et al. ACCFAHA guideline for the management of heart failure A report of the American College of Cardiology FoundationAmerican Heart Association task force on practice guidelines. Circulation. ee. For Novartis multimedia content please visit http For questions about the site or required registration please contact journalisthelpthenewsmarket.com mailtojournalisthelpthenewsmarket.com. SOURCE Novartis Pharmaceuticals Corporation Related Links http"

"Women who take bone drugs for several years have a slightly increased chance of suffering an unusual type of thigh fracture according to a large Canadian study. The findings add to earlier concern over the medicines called bisphosphonates whose U.S. labels have been required since October to include a warning about the thighbone fracture risk. However researchers stress the drugs are effective at preventing fractures of the hip or spine which are much more common in elderly people with the bonethinning disease osteoporosis. And the actual risk of having one of the unusual fractures was low said Laura Y. ParkWyllie of St. Michaels Hospital in Toronto who worked on the new study. Women with osteoporosis who are at high risk of fractures should not stop taking their treatment she told Reuters Health. Bone drugs include Mercks Fosamax Roches Boniva Novartiss Reclast and Warner Chilcotts Actonel. Some million Americans currently suffer from bone thinning according to the National Osteoporosis Foundation. The majority are postmenopausal women. ParkWyllie and colleagues tapped into data on more than Ontario women at least years old who had taken the bone drugs. Their findings appear in the Journal of the American Medical Association. Overall women suffered the unusual type of thighbone fracture after starting the bone drugs and nearly had typical hip fractures. The risk of a thighbone fracture differed depending on how long the women had been taking the medicine. After taking bone drugs for five years about one in women went on to suffer a thigh fracture over the next year. That works out to nearly three times the risk of those whod taken the drugs for roughly three months or less after accounting for other risk factors. On the other hand longer treatment was tied to a percent decrease in hip fractures which along with wrist and spine fractures affect about half of all people with osteoporosis. There are several alternative ways to treat osteoporosis including hormone treatment for women. And one preliminary study published along with the Canadian findings in JAMA hints that the common heart medication nitroglycerin might also boost bone health. So far however the cheap and effective bisphosphonate bone drugs remain the most popular treatment option. But some experts worry that negative media coverage might have led to more fractures and possibly deaths by dissuading patients from taking the drugs. The bad news is that overstating the levels of risk of side effects with these drugs which the media have been doing for some time now has led people to stop the drugs when they should be taking them said Dr. Ethel S. Siris who heads the Toni Stabile Osteoporosis Center at Columbia University in New York. Apart from atypical fractures the most serious side effect of the bone drugs is bone death or osteonecrosis of the jaw. But thats a very rare problem experts say which only affects about one in people on bisphosphonates. If youre taking the drugs and youve been on them for a while but arent sure if youre at high risk you should ask your doctor about it ParkWyllie advised. The U.S. Preventive Services Task Force a federal expert panel recommends screening all women over for osteoporosis. SOURCE bit.lyHWZ httpbit.lyHWZ JAMAJournal of the American Medical Association online February . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Almost two million Americans have severe heart failure and for them even mundane tasks can be extraordinarily difficult. With blood flow impeded throughout their bodies patients may become breathless simply walking across a room or up stairs. Some must sleep sitting up to avoid gasping for air. Drugs may help to control the symptoms but the disease takes a relentless course and most people with severe heart failure do not have long to live. Until now there has been little doctors can do. But on Sunday researchers reported that a tiny clip inserted into the heart sharply reduced death rates in patients with severe heart failure http In a large clinical trial doctors found that these patients also avoided additional hospitalizations and described a drastically improved quality of life with fewer symptoms. The results reported at a medical meeting in San Diego and published simultaneously in the New England Journal of Medicine were far more encouraging than heart specialists had expected. Its a huge advance said Dr. Howard Herrmann the director of interventional cardiology at the University of Pennsylvania which enrolled a few patients in the study. It shows we can treat and improve the outcomes of a disease in a way we never thought we could. If the device is approved by the Food and Drug Administration for treatment of severe heart failure as expected then insurers including Medicare most likely will cover it. Like the Science Times page on Facebook. httpon.fb.mepaTQh Sign up for the Science Times newsletter. httpnyti.msMbHaRU In heart failure the organ itself is damaged and flaccid often as a consequence of a heart attack. The muscle pumps inefficiently and in an attempt to compensate the heart enlarges and becomes misshapen. The enlarged organ tugs apart the mitral valve which controls blood flow from the left atrium into the left ventricle. The distorted valve functions poorly its flaps swinging apart. Blood that is supposed to be pumped into the body backs up into the heart and lungs. A vicious cycle ensues The heart enlarges so the mitral valve leaks. The leaky mitral valve makes the heart enlarge even more as it tries to compensate and heart failure worsens. In the new study a device called the MitraClip was used to repair the mitral valve by clipping its two flaps together in the middle. The clip is made by Abbott which funded the study outside experts reviewed the trial data. The result was to convert a valve that barely functioned into one able to regulate blood flow in and out of the heart. Until today researchers were not sure that fixing the mitral valve would do much to help these patients. A smaller study in France with similar patients failed to find a benefit for the MitraClip https But that research included many patients with less severe valve problems the procedure was not performed as adeptly and the patients medications were not as well optimized as in the new study. In the new trial patients with severe heart failure in the United States and Canada were randomly assigned to receive a MitraClip along with standard medical treatment or to continue with standard care alone. Among those who received only medical treatment were hospitalized for heart failure in the ensuing two years. Sixtyone died. In contrast just who got the device were hospitalized for heart failure during the period and died. The results have left leading researchers unexpectedly optimistic. The trial sends a very very powerful message said Dr. Gilbert Tang a heart surgeon at Mount Sinai Medical Center which enrolled a patient in the trial. This is a game changer. This is massive said Dr. Mathew Williams director of the heart valve program at NYU Langone Health which had a few patients in the study. Estimates of how many heart failure patients in the United States are like those in the trial range from . million to . million Dr. Williams said. But he adds the number who might ultimately be treated will be less than the number who could be treated. The device itself costs about not counting the cost of the hospital and doctors a surgeon an interventional cardiologist and an echocardiologist among others all in the operating room. Cardiologists said the study was impeccably executed. The doctors inserting the device first had to demonstrate their expertise doing so. An independent group of experts ascertained that patients medical care was optimal all too often heart failure patients do not receive ideal treatment. Patients with severe heart failure often are gravely ill too sick to have openheart surgery to have mitral valves replaced. Its not worth the risk said Dr. Gregg Stone of Columbia University Medical Center and NewYorkPresbyterian Hospital the studys principal investigator. Dr. Stone reported no relevant conflicts but said that Columbia University gets royalties from the sale of the MitraClip. But the new procedure is much less invasive than openheart surgery. A cardiologist threads the device to the heart through a blood vessel in the groin. Once it reaches the heart the MitraClip is guided to the valve and the device is used to clip the two flaps together. Not every cardiologist is equipped to insert the clip. These are difficult procedures that require training and dedication Dr. Herrmann said. During the procedure for example a tiny echocardiogram camera is placed into the patients esophagus behind the heart to show where the catheter with the clip is going. Doctors must watch an Xray screen and an echocardiogram as they guide the clip to the mitral valve. When the clip arrives you have to see where you are grasping to get a good result Dr. Tang said. The device is already approved by the F.D.A. for patients too frail for surgery but whose hearts are fine except for a mitral valve that does not function properly. Advertisement Cardiologists predicted the F.D.A. would quickly approve the device for patients with severe heart failure as well. It already is used in Europe for these patients but there had been no rigorous studies showing it helped. The new trial promises to alter prospects for many people with severe heart failure who had relatively few options. This will change how we treat these patients Dr. Williams said. Its possible he added that many would fare even better with the valve repair procedure if they were not so frail when they got it. Maybe we need to start intervening earlier he said."

"A fiveminute neck scan could predict a persons risk of developing dementia a full decade before symptoms emerge researchers have said. The test which analyzes the pulse of blood vessels in the neck could become part of routine testing for cognitive decline according to the study http by scientists at University College London UCL who presented their work Sunday at the American Heart Associations annual scientific conference. A group of almost patients aged had ultrasounds on their necks in before having their cognitive functions monitored for up to years from to . Why wellness retreats are tourisms next big thing In Asia the huge growth in highclass wellness retreats is changing the landscape of medical treatment and tourism. People with the most intense pulses which pointed to a greater and more irregular blood flow were up to more likely to suffer reduced cognitive functions the research found because the strength with which blood traveled into their brains caused damage to the brains network of blood vessels. Pulses become more intense when arteries near the heart are worn down usually by lifestyle factors such as poor diet and drug use and can no longer cushion the blood flow coming from the heart. If you can detect the risk in people in midlife it really gives an impetus to those people to change their lifestyle said Dr. Scott Chiesa postdoctoral researcher at UCL. Whats good for the arteries is good for the brain he added in summary of his findings. Dementia is not an inevitable cause of aging. How you live your life... has a real impact on how quickly your condition can decline. If the findings are confirmed by larger studies they could vastly improve the ability to detect dementia in middle age. And the scans would be well set up for routine testing according to Chiesa. Its very easy to do and its very quick to do. When healthy arteries around the heart can regulate the blood being pumped from the organ ensuring that it flows smoothly and at a constant rate to the brain. But damage to the arteries means blood flows more aggressively and irregularly through vessels and into the brain which can damage its network of blood vessels and cells. Over time the researchers believe this led more frequently to cognitive decline in participants in the study. What we do know is that the blood supply in the brain is incredibly important and that maintaining a healthy heart and blood pressure is associated with a lower risk of developing dementia said Carol Routledge Director of Research at Alzheimers Research UK who was not involved in the research. Vascular dementia is directly caused by reduced blood flow to the brain and this can also play a role in the development of Alzheimers disease studies have found. Those two conditions make up the vast majority of cases of dementia. Dementia is an umbrella term used to describe symptoms related to the loss of brain function. Alzheimers disease and vascular dementia make up the vast majority of cases. Around million people suffer from dementia worldwide according to the World Health Organization http with numbers projected to rise to million by . In the United States the condition is the sixth biggest cause of death among all adults according to the US Centers for Disease Control and Prevention while in the UK it has overtaken heart disease as the leading cause of death according to the Office for National Statistics. Promising findings The studys findings have been met with cautious optimism by dementia organizations. Getting a diagnosis of dementia can be time consuming and quite frustrating for many people so its promising that earlier indicators of cognitive decline are in development said Paul Edwards Director of Clinical Services at Dementia UK. But he added that focus should also be paid to dementia sufferers after their diagnosis saying The elephant in the room is the lack of support for people and their families once they get a diagnosis of dementia. There is currently no cure for dementia though medication can be used to temporarily treat its symptoms. Often a diagnosis is made and then people are sent home with no information no followup appointments and no clue about what is going to happen next. Previous studies this year have linked dementia risk to lifestyle factors such as alcohol consumption https and fitness level https but its effects remain largely incurable. More research is needed to determine whether neck scans should become a part of routine testing for dementia. While these findings are interesting as the full data from this research is yet to be published it is difficult to assess how useful this kind of scan could be said Routledge. Routledge added that current evidence shows that not smoking only consuming alcohol within recommended limits staying active monitoring cholesterol levels and eating a balanced diet can all help with the health of the heart and brain."

"The makers of POM Wonderful pomegranate juice say that the drink improves blood flow and heart health prevents and treats prostate cancer and works percent as well as Viagra whatever that means. All for about four bucks a bottle. Those impressive claims helped the company rack up million in sales in . They also earned the disapproval of the Federal Trade Commission FTC. Last month the agency sued POM Wonderful for making false and unsubstantiated health claims and is asking the company to remove the claims from its ads. A percent juice drink that contains antioxidants and no added sugar POM is just one of many beverages that bill themselves as promoting better health. VitaminWater kombucha tea coconut water and various brands of juice drinks made from acai goji berry and mangosteen have all used health claims in their marketing and some like POM have been the subject of scrutiny and legal action. The FTC along with the Food and Drug Administration FDA has been cracking down on food and beverage makers for allegedly overselling the health benefits of their products. In alone the FDA warned companies that they were providing misleading nutritional information on their packaging or making overly specific health claims. Health.com dietbusting foods you should never eat http Not all of the products were drinks but the beverage category stands out says Bruce Silverglade director of legal affairs at the Center for Science in the Public Interest a consumer advocacy group based in Washington D.C. At first blush it seems that beverage products are certainly a large proportion of food products that make bogus healthrelated claims. Drinks such as POM have become increasingly popular with consumers in recent years thanks in part to public health campaigns against soda that have been prompted by the obesity epidemic. The trend is away from traditional soda pop toward products claiming to provide magical health benefits Silverglade says. Are the health claims true Yes and no. The federal government doesnt require companies to vet health claims with the agency before plastering them on product packaging as long as the claims are accompanied by a disclaimer about their uncertainty. But that doesnt mean the claims are invented most are based in research. The research is often funded by the manufacturers however and industryfunded research can be prone to bias. A study found that research on health drinks that was funded entirely by beverage companies was between four and eight times more likely to find a favorable result than research with no industry support. If a cell phone company told you they tested all the models and their model came out the best would you believe it Probably not says Dr. Lenard Lesser M.D. one of the coauthors of that study and a researcher at UCLA. The same is true with nutrition research but the stakes are higher because were putting our bodies at risk. Wheres the line between research and marketing httpedition.cnn.comHEALTHcompany.funded.researchindex.html Sounds great hard to believe However farfetched the claims may sound POM is standing behind them. Two weeks before the FTC publicly announced its lawsuit POM preemptively sued the FTC claiming that preapproval of ads featuring health claims violates the companys right to free speech. But are shoppers really convinced that POM can unclog their arteries cure cancer and lead to hotter sex There seem to be more than a few believers out there. I started drinking POM after reading the studies two years ago my triglycerides were almost one of POM Wonderfuls fans breathlessly posted on Facebook after the FTC announced its lawsuit. Working out everyday drinking POM and eating healthy they are now less than . Forget what the Feds say I believe A triglycerides level of is still nearly three times higher than whats considered normal. Most health beverage drinkers arent as enthusiastic as the realtor from Alaska who posted the above testimonial. Quinton Ma a yearold marketing coordinator at Gawker Media in New York City started to drink VitaminWater as a middle schooler because it seemed like a healthy alternative to soda. I figured that if they were selling something that I could get extra vitamins from it couldnt hurt to drink Ma says. Once I learned they were really just cleverly marketed sugar waters I stopped. Health.com You are what you drink httpeating.health.comnewresearchyouarewhatyoudrinkcnnyes But the fact is even when people dont buy the health claims they often still buy the beverage. Thats the paradox of products such as POM Silverglade says The health claims on these products strain the imagination yet studies have repeatedly shown that health claims sell food. Thats because these claims however improbable they may seem distract shoppers from the real nutritional information and hook consumers with buzzwords like antioxidant. This phenomenon is known as a health halo an aura of healthfulness attached to a product based on labels like lowfat allnatural or made with whole grains that seduces consumers into overeating. According to a study by the FTC this halo effect can even lead people to overlook warning statements about the high sodium content of a product for example. A healthy halo develops around products like these says Frances LargemanRoth R.D. Health magazines senior food and nutrition editor. The healthconscious consumer incorporates them into their lifestyle thinking that theyre doing a world of good for themselves. Health.com Food label knowhow mistakes even savvy shoppers make httpeating.health.commistakesshoppersmakecnnyes Ceating a health halo The makers of POM Wonderful have spent million on scientific research on POM products and pomegranates. According to the FTCs complaint the studies POM has funded do not substantiate the companys claims and a closer look at the research seems to bear that out. One of the most prominent claims that POM can decrease arterial plaque by percent was taken from a single pilot study that included just people and was funded by the makers of POM. Another claim that POM drinkers experience a percent improvement in blood flow was taken from another POMfunded study that included just people and only lasted for three months. These days its possible for a food company to pay just about anybody to conduct a study says Silverglade. Michael Aviram Ds.C. a cholesterol researcher at Rambam Medical Center in Haifa Israel defended his studies on pomegranates many of them funded by POM by noting that they were published in very prestigious peer reviewed journals including the American Journal of Clinical Nutrition and Atherosclerosis. Dr. Harley Liker M.D. a physician at UCLA Medical Center who has also led research funded by POM directed all inquiries to a POM spokesman. A grocery store is a designed marketing environment to get people to buy things says Lesser. Lots of products are going to try to use health claims from research often from their own industry just to sell a product. Health.com health products you probably dont need http Iffy health claims dont mean that products like pomegranate juice should be avoided at all costs says Keri Gans R.D. a spokesperson for the American Dietetic Association. As long as consumers limit themselves to ounce servings and products with no added sugar juice can be an excellent source of vitamins and other nutrients Gans says. But its not going to solve any of your health issues she adds. The bottom line is that consumers shouldnt believe everything they read on labels. If they focus on consuming an overall wellbalanced diet they might not need to focus so much on finding a product that makes false promises Gans says."

"Patrick Hetzner tried diets and exercise just about everything short of stomach stapling to lose weight. Nothing worked. Five months ago he tried something new a stomach pacemaker that curbed his appetite. Since having it implanted Hetzner a yearold Munich mailman has knocked off more than kilos pounds from his earlier weight of kilos pounds. Hetzner got the device as part of a clinical trial. Since being approved by Britain last month the device is available for sale across the European Union. It works a bit like a cardiac pacemaker and consists of a stimulator and a sensor surgically implanted onto the stomach. The stimulator sends out electrical pulses meant to trick the stomach and brain into thinking the body is full. Hetzner said the pulses kick in a few minutes after he starts eating or drinking. He said they make him feel full after finishing about half the amount of food he would normally eat. It feels like a little pressure on my stomach or a tickle but its not a bad feeling he said in a telephone interview. Advertisement Its been like a little guide to help me change my life he said. So far about patients in two studies have received the device from U.S. pacemaker manufacturer Intrapace. Only about half of those have had the pacemaker for at least a year and most lost about percent of their weight and kept it off. Other stomach pacemakers are on the market but most are used to relieve symptoms like nausea and vomiting not to fight obesity. Appetite is partly controlled by signals sent from nerves around the stomach to the brain the stomach pacemaker taps into that communication system sending a message to the brain that the body is full after a relatively small amount of food is consumed. If you can stimulate the nerves going from the stomach to the brain that should indeed have an effect in reducing food intake said Stephen Bloom an obesity expert at Imperial College in London who is not connected to Intrapace or the clinical trials. Bloom however questioned whether the device would work longterm as people might eventually get used to the electrical pulses and keep eating anyway. Doctors familiar with the pacemaker say there will always be ways for patients to eat and work around the system. We could make the stomach pacemaker work so people feel like theyre going to throw up but we dont want that said Thomas Horbach chief of surgery at Stadtkrankenhaus Schwabach near Munich who led one of the trials. If you take away all the responsibilities from the patient they will not change on their own. As an additional benefit the sensor tracks when patients eat drink or exercise so patients can chart their progress. Intrapace has also created an online network for patients to trade weight loss advice and share experiences. Other surgical approaches to weight loss come with serious side effects. People who have their stomach stapled or have a gastric band must eat smaller amounts of mostly lowfat foods because their stomachs cant accommodate or process large volumes. If they overeat they will feel nauseous vomit or suffer from other problems. The most serious side effect seen in the pacemaker has been an infection linked to surgery. In Britain the pacemaker costs about pounds including the keyhole surgery used to implant it. Intrapace President Chuck Brynelsen said thats comparable to other weight loss surgeries. The device is authorized for sale across the EU though the company is first targeting weight loss clinics in Britain Germany and Spain. It also plans to submit the device for approval in the U.S. once it has more data and hopes it will be available there in . The pacemaker hasnt yet been implanted commercially in Europe but Intrapace is in talks with clinics interested in offering it. Brynelsen said the battery in the device lasts about five years and it will be up to patients how long they want to keep the pacemaker. We dont know if patients will see the stomach pacemaker as a bridge to recovery or whether this is a crutch they will need for the longer term he said. Some experts said the pacemaker did not address peoples underlying reasons for overeating. The problem with these devices is they assume people are rational and that they eat because theyre hungry said Stephan Rossner a professor in the obesity unit at Karolinska University Hospital. A lot of obese patients eat because theyre depressed they cant sleep at night or they have nobody to have sex with he said. So whatever you insert into their stomach they can outeat that device because its other things that drive them to consume. Hetzner said he intends to keep the stomach pacemaker for about four years. I dont want to backslide he said adding he would recommend the device to others. I want to be sure I can stick with it and that my body adapts to this new way of eating. ___ Online http"

"After three years teens with severe obesity who underwent stomach reduction surgery to lose weight also significantly improved their heart health. A study published httpdoi.org.peds. Monday in Pediatrics shows that blood pressure cholesterol inflammation and insulin levels all improved particularly among those who lost the most weight. The potential impact of such risk reduction translates into a reduced likelihood of developing significant heart disease later in life including atherosclerosis heart failure and stroke says study author Marc Michalsky http surgical director of the Center for Healthy Weight and Nutrition at Nationwide Childrens Hospital in Columbus Ohio in an email. This study serves to reinforce the benefits of bariatric surgery as a safe and effective treatment strategy that should be considered sooner rather than later. Younger adolescents in the study showed bigger improvements in their cholesterol and inflammation levels than the older teens. Even participants who had normalrange blood pressure triglycerides or cholesterol levels before surgery saw improved measures. Nearly a third http of all children and teens are overweight or obese in the U.S. and an estimated to percent have severe obesity. The greater a persons obesity the greater their risk of high blood pressure heart disease Type diabetes and organ damage. The findings are important because many of the participants in this study likely already had some level of cardiac damage such as thickened arteries or heart walls says Geetha Raghuveer http a pediatric cardiologist at Childrens Mercy Kansas City in Missouri who was not involved in the study. If you have very high blood pressure or lipids cholesterol or diabetes you do see cardiovascular changes even at a very young age Raghuveer says. They may not be having a heart attack or stroke in their teens and s but theyre closer to having those in their s and s. Article continues after this message from our sponsor Among teens in the study of them underwent a RouxenY gastric bypass procedure httpasmbs.orgpatientsbariatricsurgeryproceduresbypass underwent a vertical sleeve gastrectomy httpasmbs.orgpatientsbariatricsurgeryproceduressleeve and received an adjustable gastric banding httpasmbs.orgpatientsbariatricsurgeryproceduresband. The study authors had no part in which procedures the teens received. They collected data from the five participating medical centers for their observational study and decisions about procedures depended on each centers clinical practices. The teens ages to when the study began had a body mass index BMI between and with half over . Medical providers use BMI the ratio of a persons weight to height to estimate body fat http_wtrisk.htm. A BMI over is considered overweight over is obese. The obesity classification with the highest risks of health problems is a BMI of or higher. The risk factors measured in the study included elevated blood pressure above mgHg high cholesterol high insulin levels in the blood and abnormally high levels of Creactive protein http_vascular_instituteclinical_servicescenters_excellencewomens_cardiovascular_health_centerpatient_informationhealth_topicsc_reactive_protein.html an indicator of inflammation in the body. The higher a persons insulin levels are the more likely they are to have or develop insulin resistance which can increase blood sugar levels and diabetes risk. High insulin levels may also contribute to increased blood pressure and increase the risk of atherosclerosis http_UCM__Article.jsp.WkASOZNo when fat clogs the arteries. Three years after surgery teens who underwent a gastric bypass had a percent drop in their BMI similar to the percent drop in those who had the sleeve gastrectomy. Those with the gastric band had an percent drop in BMI. Before surgery only percent of the teens had no cardiac risk factors at all but three years later just over half of them percent had no risk factors. Just percent had all four cardiac risk factors before their surgeries but none had all of them three years later. In fact the majority of the participants percent had only one or no risk factors three years after their surgeries. The proportion of participants with two or three risk factors also dropped substantially. One of the surprises was that almost all patients benefited as a result of the surgery says M. James Lenhard httpdoctors.christianacare.orgdetails the medical director of Christiana Care Health Systems Diabetes Metabolic Diseases Center in Wilmington Del. who was not involved in the study. The average BMI three years after surgery was still considered very obese he says. And yet they still had significant improvements in cardiovascular risk factors Lenhard says. The results were impressive. The studys biggest limitation is its very selective population. Most of the participants were female most were white and most received the gastric bypass. Children of color have the greatest risk of obesity heart disease and Type diabetes but its not clear whether they would see the same improvement with these procedures. Lenhard expects the odds are very good that they would and Raghuveer would be cautiously optimistic that the findings would be similar regardless of sex or ethnicity. The population also included only teens with the greatest obesity who were also unsuccessful trying other weight loss methods. Severe obesity is notoriously difficult to treat with anything other than surgery Lenhard says. The results of this study suggest that performing surgery at a BMI even lower than would provide even better outcomes. An estimated adolescents undergo metabolic or bariatric surgeries each year the study notes but families should only consider such procedures after exhausting other treatment options. This is not a procedure you would consider for any obese patient who walks through the door Raghuveer says. It would be considered for the highly obese and those not responding to any behavioral modifications physical activity or calorie restriction. Before undergoing bariatric surgery teens and their families receive extensive counseling Michalsky says. Teens considering bariatric surgery should have a frank discussion with their family and primary care provider and seek detailed information from wellestablished bariatric surgery centers that are specifically dedicated to treating adolescents he adds. All three procedures carry the same risks as any surgical procedure such as infections blood clots and bleeding Lenhard said and a common risk of sleeve gastrectomy is bleeding where the stomach is reconnected httpmedlineplus.govencyarticle.htm. People who have a gastric bypass often have nutritional and vitamin deficiencies Lenhard said. And gastric banding has low effectiveness and a risk of the band slipping down the stomach. Getting longer term data is important too. Three years is a good followup time for this type of study and it has many more participants than similar studies. However three years is not a long time overall in the life of a child Raghuveer says. Id be curious what happens to these kids at years years later. Michalsky says the study is ongoing and they expect to continuing gathering information for years to come. Ideally public health efforts should aim for better obesity prevention including parent education and interventions when children are toddlers and preschoolers according to Raghuveer. A generational divide has left fewer families knowing how to fix meals she says and more families need to learn to cook and avoid packaged foods and microwave dinners. The big question is how do we prevent obese kids from getting to this point where they would need an invasive surgical procedure Raghuveer says. The bigger message should be that we should get to a point in society where we are not managing obesity but we are preventing obesity."

"What would happen if screening for male infertility was just about as easy as taking a pregnancy test in your home bathroom Thats the question researchers at Brigham and Womens Hospital and Massachusetts General Hospital tried to answer when they went about developing a smartphonebased test that men could use to test their semen https in the comfort of their homes. The test delivered impressive results identifying abnormal semen samples with approximately percent accuracy according to the researchers who published their findings httpstm.sciencemag.orgcontenteaai Wednesday in the journal Science Translational Medicine. Infertility affects up to percent of the male population worldwide. Though its as common as female infertility it often goes unrecognized due to factors like cultural stigma the high cost and time required for testing and access to laboratory facilities. As things stand now men have to provide samples in these specific rooms in hospitals under so much stress and embarrassment the studys principal investigator Hadi Shafiee PhD told CBS News. His teams new approach aims to change that with a simple and inexpensive athome test option. The smartphonebased test involves several distinct parts one a disposable device on which to place the sample including a disposable microchip that handles the sample two an optical attachment that connects to a smartphone three an app that guides the user through each step of testing. The researchers say the optical attachment could be created by Dprinting and the device would only cost about . The testing kit also includes a tiny weight scale that connects wirelessly to the testing app and measures the total number of sperm swimming in the sample. The researchers tested the device on clinical semen specimens in Massachusetts including both trained and untrained users in their trial. The accuracy of this approach was very similar to that of computerassisted laboratory analysis even when it was performed by untrained users with no clinical background they wrote in the study. The app is similar to a fitness tracker in a sense in that it stores any history of previous semen samples as well. The apps user experience is hard to forget users can see vivid moving images of their sperm right on the screen. Though the system is in the prototyping stage it could eventually shake up the world of fertility testing by allowing men to evaluate their sperm in their own homes and helping health centers with fewer resources offer easy cheap testing. In addition the developers say it could also potentially be used by men who have had a vasectomy to monitor their progress at home following surgery. Currently theyre required to make office visits to a urologist for several months to ensure that the operation was successful. Shafiees team plans to continue refining the test and then file for approval from the Food and Drug Administration FDA. Several other homebased tests are already on the market but Boston researchers say their version can analyze additional aspects of the sample checking how well the sperm move known as motility as well as their concentration. Male infertility https has a range of root causes from low or abnormal sperm production to blockages to illness."

"An easy twominute vision test administered on the sidelines after a young athlete has hit his or her head can help to reliably determine whether the athlete has sustained a concussion according to a new study of student athletes https some as young as . The test is so simple and inexpensive that any coach or parent potentially could administer it the studys authors believe and any league afford to provide it as a way to help evaluate and safeguard players. Those of us who coach or care for young athletes know by now that an athlete who falls or collides with something during play or seems dazed dizzy loses consciousness or complains of head pain should be tested for a concussion which occurs when the brain is physically jostled within the skull. But most of us are clueless about how to test young athletes. The most commonly recommended sideline test is the Standardized Assessment of Concussion a multipart examination during which athletes are asked to name the date describe how they feel memorize and recall lists of words and do jumping jacks and other tests of coordination. Ideally this assessment should be administered and evaluated by a medical professional. But while the sidelines of college and professional games are crowded with doctors and certified athletic trainers few high schools and youth leagues have those resources. Most of the time concussion testing in youth sports falls to volunteer coaches or parents with little if any medical experience. That situation prompted researchers at New York Universitys Langone Concussion Center https to begin wondering recently whether there might be other easier diagnostic tools to check young players for concussions. Their thoughts soon turned to vision. About percent of the brains pathways are tied in some to way to vision and visual processing said Dr. Steven Galetta chairman of neurology at N.Y.U. Langone Medical Center and senior author of the study which was published in The Journal of NeuroOphthalmology https Eye tests can tell evaluators a great deal about how well someones brain is working. But for the most part visual tests have not been part of the standard protocol for sideline concussion testing of young athletes. However the N.Y.U. researchers knew that in recent years trainers working with athletes in sports such as boxing and mixed martial arts where concussions are common had begun supplementing the Standardized Assessment with a simple vision exam known as the KingDevick test during which someone reads slightly jumbled lines of numbers printed on three cards as quickly as possible. See below for more information. The KingDevick test measures rapid eye movement visual tracking and related cognitive responses and is a reliable indicator of cognitive problems. If an injured adult reads the numbers more slowly after a head impact than in baseline testing he or she is considered to have sustained a concussion. The test requires no medical training. But it had not been evaluated for use in young athletes. So the N.Y.U. researchers decided to test it. They recruited young hockey and lacrosse players between the ages of and and collegians from the same sports. These athletes all completed a baseline Standardized Assessment of Concussion exam during preseason and walked as fast as possible along a narrow foot long strip of athletic tape to measure their balance. They also completed the KingDevick test. Then they went out to play. During their subsequent competitive seasons athletes hit their heads and were put through the full battery of sideline concussion tests by parents or coaches under the supervision of N.Y.U. medical personnel. Fourteen agematched uninjured athletes in the same sports completed the same tests to serve as controls. Neurologists later confirmed that the injured athletes had sustained concussions. Then the N.Y.U. researchers compared how well the various sidelines tests had done at pinpointing the brain injury. The Standardized Assessment of Concussion had performed rather miserably correctly identifying only two of the concussed athletes missing and finding that three of the uninjured control athletes had supposedly sustained a concussion since their scores had declined compared with their baseline almost certainly the studys authors believe because these young athletes were physically tired. The KingDevick test did much better correctly assessing concussion in percent of the young injured players and inaccurately identifying it in only one. The pacealongthetape test was also relatively accurate. Ten of the injured athletes were slower now but so were five of the unhurt players. Overall the KingDevick test had by far the greatest accuracy and lowest risk of false positives. The upshot Dr. Galetta believes is that parents and coaches should absolutely consider familiarizing themselves with the KingDevick test and administering it to young athletes before the season starts then having those baseline numbers and the test itself handy on the sidelines. If an athlete hits his or her head and is then slower than baseline by even a fraction of a second at reading off the numbers Dr. Galetta said it is very probable he or she has a concussion and needs to be taken from play and seen by a doctor. It is still too early to say however whether the KingDevick test can replace other more conventional concussion evaluations for young athletes including the standardized assessment despite its shortcomings in this study Dr. Galetta cautioned. For now he says it probably should be used in conjunction with other tests. How to Administer the KingDevick Concussion Test During preseason use a stopwatch to time the athlete as he or she reads off the numbers on each line from left to right as quickly as possible. The cards should be read in order. This establishes a baseline time. For the greatest precision you might want to have athletes perform the test twice and use their best reading. During the season if an athlete is suspected of sustaining a concussion have him or her repeat the test on the sidelines. If the time is slower even by a small amount he or she probably has a concussion according to neurologists. Interestingly uninjured athletes are almost always faster at reading the numbers during games or practices because physical exertion sharpens the kind of visual performance being tested."

"When symptomfree people have heart scans to look for clogged arteries they can end up with overtreatment and side effects researchers said Monday. In a study published in the Archives of Internal Medicine they found people who had the scans were much more likely to be put on medications and undergo surgery than those who chose standard health screening. The scans called coronary computed tomography angiography or CCTA produce a detailed image of the heart that reveals cholesterol buildups in the coronary arteries. If they get big enough such buildups may cut the blood flow and cause a heart attack. So in theory treating them early on might help stave off some the more than . million heart attacks a third of them fatal that occur every year in the U.S. Yet theres no evidence that treating people based on heart scan results does any good said Dr. John McEvoy of Johns Hopkins Ciccarone Center for the Prevention of Heart Disease in Baltimore who led the new study. By contrast its well known that the scans expose patients to a high dose of Xrays which can increase their likelihood of developing cancer. And the dyes used to enhance the images cause kidney damage in a significant portion of people. Testing might lead to more harm than good McEvoy told Reuters Health adding that heart scans may cost or more. His team looked at Korean patients who chose to get a heart scan as part of a health screening program at Seoul National University Bundang Hospital. The researchers compared those patients to closely matched individuals who opted to forgo the scans not currently recommended by guidelines and just get the standard health checkup. More than a fifth of the patients who got scanned had cholesterol buildups in their arteries also called atherosclerosis. Three months later these individuals were using cholesterollowering statins percent of the time and bloodthinning aspirin percent of the time. In those who tested negative for atherosclerosis or didnt get scanned less than percent used the medications. People who got scans also had more additional tests and major heart procedures. The researchers expected that if the extra drugs and procedures were actually helpful the treated people would have a lower rate of serious heart problems in the future. But after another months there was no such difference. There was just one event in the people who had CCTA one case of hospitalization for chest pain and one in the people who didnt a heartrelated death. Currently whether a patient gets statin or aspirin is based on risk factors such as their age and how much cholesterol is in their blood. Both drugs have side effects notably joint problems and bleeding ulcers. Although the study cant prove that getting a scan caused the extra medication use the gap could not be explained by differences in risk factors for heart disease such as cholesterol levels or smoking. In an editorial Dr. Michael S. Lauer of National Heart Lung and Blood Institute in Bethesda Maryland said the new study serves as a reminder of the downsides of screening. Physicians cannot easily ignore diagnoses made with screening tests because it is impossible for them to determine whether their patients have real disease or pseudodisease Lauer notes. Therefore physicians prescribe tests medications procedures or even surgical procedures all of which carry inherent risks. McEvoy agrees. With these new imaging techniques we are left with the dilemma of what to do with the results he said. Even when screening helps predict health problems down the road Lauer adds that doesnt mean treatments are necessarily beneficial. Overdiagnosis is threatening to become an increasingly important public health problem because of the enthusiasm for and proliferation of unproven screening tests Lauer writes. McEvoy said there have been several reports of doctors doing CCTA heart scans in healthy patients although the practice is currently discouraged by the American Heart Association. According to McEvoy doctors should focus on patients lifestyle and traditional risk factors such as smoking and obesity. SOURCE bit.lylEEptL httpbit.lylEEptL and bit.lykBzXJ httpbit.lykBzXJ Archives of Internal Medicine online May ."

"Doctors can use a patients abdominal CT scans to also check for signs of the boneweakening disease osteoporosis according to a new study. The researchers who published their findings in the Annals of Internal Medicine on Monday compared patients CT scans to their dualenergy Xray absorptiometry DXA which is traditionally used to diagnose osteoporosis. What we found is that there is pretty good correlation said the studys lead author Dr. Perry Pickhardt professor of radiology at the University of Wisconsin School of Medicine and Public Health in Madison. The idea say the researchers is doctors can use patients CT scans that are ordered for another reason such as looking for tumors to also check for signs of osteoporosis. That may spare the patients from additional testing and additional costs. In an editorial accompanying the study however experts wrote that using CT scans to gauge bone density could lead to some people being incorrectly diagnosed particularly if people at low risk are tested. In this study the average age was about years old six years younger than the age at which the U.S. Preventive Services Task Force a governmentbacked panel recommends all women begin being screened for osteoporosis. The disease affects over million Americans over . The panel also suggests younger women at an increased risk for bone fractures should be screened but theres no recommendation for men of any age. Despite DXA scans being safe and cost effective Pickhardt and his colleagues say the test is underused. CT scans however are considered overused with more than million performed in the U.S. during . INCIDENTALOPOROSIS For the new study the researchers analyzed test results from patients who had both types of scans performed within six months of each other over a year period to see if their CT scans showed osteoporosis as well as the DXAs. Overall about percent of the people were diagnosed with osteoporosis about percent were diagnosed with some boneweakening and about percent were healthy based on their DXAs. Sponsored The researchers then found that their ability to accurately diagnose those same patients with osteoporosis from a CT scan depended on what threshold for bone density they used. Dr. Sumit Majumdar who wrote an editorial accompanying the new study said a lower threshold for bone density would catch most cases of osteoporosis and limit incidentaloporosis incorrect osteoporosis diagnoses discovered while doctors were looking for something else. At the lower threshold the researchers found percent of those diagnosed with osteoporosis were misdiagnosed. Pickhardt said the screenings would have to target the right groups of people to prevent overdiagnosis. Obviously its something we need to worry about but if you apply it to a population thats suitable for diagnosis you wouldnt run that risk he said. CT v. DXA Majumdar a professor of medicine at the University of Alberta in Canada said CT scans are better tests but stomach scans dont include the hip like a DXA would. A DXA can cost a couple hundred dollars while a CT scan can cost about . Both involve radiation. ADVERTISING Dr. Beatrice Hull from the Center for Osteoporosis and Bone Health at the Medical University of South Carolina in Charleston told Reuters Health that shed want her patients to have a DXA scan even with a diagnosis from a CT scan. I dont think at this point this one test is going to prevent further testing. I think it will identify patients who are at a higher risk and need more testing said Hull who wasnt involved with the new research. SOURCE bit.lyZwiu httpbit.lyZwiu Annals of Internal Medicine online April . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"A UCLAled study has found that a treatment that uses a bacterialike agent in combination with an immunotherapy drug could help some people with advanced melanoma an aggressive form of skin cancer live longer. The research showed that using the immunotherapy drug pembrolizumab and the experimental agent SD a sequence of nucleic acids that mimics a bacterial infection altered the microenvironment around the tumor in a way that enabled the immune system to more effectively attack the cancer. The research was an earlystage study conducted to test the side effects and best dosage of a potential new combined therapy and the findings were published httpcancerdiscovery.aacrjournals.orgcontentearly.CD today in the journal Cancer Discovery. Pembrolizumab which is marketed under the brand name Keytruda works by blocking a protein called PD which interferes with immune system function. Blocking PD with pembrolizumab enables the immune system cells to better attack the cancer. While pembrolizumab has been a significant advancement for treating people with a variety of advanced or metastatic cancers a majority of metastatic melanoma tumors are still resistant to the drug. We have found that the reason patients with metastatic melanoma do not initially respond to immunotherapy with an antiPD is that their immune system was not ready said Dr. Antoni Ribas the studys lead author a professor of medicine at the David Geffen School of Medicine at UCLA and director of the UCLA Jonsson Comprehensive Cancer Center httpscancer.ucla.edu Tumor Immunology Program. So we thought What if we change that by injecting the therapy drug into the metastatic lesions and change the microenvironment of the cancer Its like having a pile of wood but not having a match to light it. With this new approach SD is the match that starts the fire. The researchers found that SD not only directs T cells to cancer cells but it also makes the microenvironment more hospitable for the T cells so that they can better kill the cancer cells. All people in the study had an advanced stage of inoperable or metastatic melanoma. Nine were receiving an immunotherapy treatment for the first time as part of the study. Seven of those nine had a positive response to the drug combination including two for whom the tumors disappeared completely. The other people in the study had previously received a type of immunotherapy before the study. Of them two had a partial response meaning parts of the tumors shrank but the tumors did not go away completely. Five more showed some reduction in the tumors but the other participants did respond to the therapy. The results of the study suggest that the combination of pembrolizumab and SD could provide an alternative treatment for people with melanoma whose tumors have not responded or would be unlikely to respond to other therapies. For all patients with advanced cancer immunotherapy using PD inhibitors has really changed the face of cancer treatment. Unfortunately this therapy still only works in a subset of patients said Dr. Deborah Wong assistant clinical professor of medicine at the Geffen School of Medicine and an oncologist at the Ronald Reagan UCLA Medical Center who was also an author of the paper. This particular combination has been especially gratifying because not only does the SD therapy drug induce tumor shrinkage at the actual site where its injected but its working in conjunction with pembrolizumab to shrink tumors outside of the ones were directly injecting. The study highlights the need for more research into combination therapies like this one because many people with cancer do not respond to immunotherapy or experience a reoccurrence of their tumors after treatment. We are really starting to understand the science of how immunotherapies work in patients said Ribas who is also the director of the Parker Institute for Cancer Immunotherapy Center at UCLA. By understanding that we can find more ways to make that therapy more active. One way is by combining the therapy with another agent that can overcome the resistance that some cancers have to these therapies. The study was funded by Dynavax Technologies Corp. which provided SD. Merck Co. provided pembrolizumab. Ribas research is funded by the Parker Institute for Cancer Immunotherapy and the National Institutes of Health."

"A seaweedbased fiber supplement taken daily before meals helped people lose weight in a new study. But that was only the case among people who stuck with the diet study over a few months. More than onefifth of people dropped out when they couldnt tolerate the supplements taste texture and side effects. Researchers have explored the potential of seaweed as an appetite suppressant but so far products havent panned out. There have been problems in the past to develop something that tastes acceptable said Dr. Arne Astrup one of the studys authors from the University of Copenhagen and a member of the advisory board to SBiotek a Danish company that provided funding for the study. Previous seaweedbased supplements were slimy and caused bloating and they also had a fishy taste. The new supplement used in this study is less unpleasant but theres still room for improvement said Astrup. The supplement is based on the seaweed extract alginate a thickening agent and a common ingredient in foods like soups and jellies. Its also increasingly used by the weightloss industry marketed as an appetite suppressant. Packaged in powder form and mixed with liquid alginate expands in the stomach to form a thick gel mimicking the effect of a large meal. This gel is really like a pudding that will last in the stomach for hours gradually degrading and disappearing Astrup said. For the study the researchers randomly divided generally healthy but obese people aged to into two groups. One group was given packets of the gel supplement containing grams of fiber and the other got a seaweedfree placebo drink. Neither the researchers nor the participants knew who was receiving the seaweed supplement. In terms of calories flavor and appearance the placebo and treatment drink were identical. For three months study participants drank the supplements dissolved in two cups of water minutes before each meal. They were also told to cut back on calories. By the end of the trial sixteen people had dropped out of the study including out of from the seaweed group according to findings published in the American Journal of Clinical Nutrition. Among people who stuck with the trial those on the fiber supplement lost pounds on average compared to pounds in the placebo group. But when all original participants were included in the analysis the researchers found no significant difference in weight loss between the two treatment groups. TREAT FINDINGS WITH CAUTION Previous studies have shown eating a highfiber diet can help reduce the hunger pangs that may lead to overeating and derail a healthy diet plan. Still the new results should be treated with caution according to Dr. Maria Vazquez Roque who has worked on alginatebased gels at the Mayo Clinic in Jacksonville Florida but was not involved in the study. Just looking at the effect of the supplement on people who finished the treatment can bias the findings she said. For Mette Kristensen one of the studys authors the message seems clear If you actually comply with the treatment you do have the improvement in weight loss. However effects on blood pressure were less promising. Systolic blood pressure the top number on a blood pressure reading fell by almost six points on average in the placebo group over the week study but by just over one point in the treatment group. At times during the trials systolic blood pressure increased in the alginate group by one to two points. According to the researchers the higher sodium content of the alginate drink a little over one gram per dose or about half a teaspoon of salt could have offset any potential bloodpressure reducing effect of the supplement. The American Heart Association recommends that adults eat less than . g of sodium per day. Questions remain about the safety of the fiber supplement over the long term. Five people taking the fiber gel left the study due to problems with stomach bloating nausea and diarrhea. Two people taking a placebo supplement which didnt contain the seaweed fiber experienced similar problems. There are many different types of alginate said Richard Mattes who has studied the effect of alginate fiber on appetite at Purdue University in West Lafayette Indiana so the trick is to find the right alginate in the right dose. And just feeling less hungry due to a supplement wont make you lose weight unless you eat fewer calories said Mattes who was not involved in the new study. The research group is working on a new supplement that uses percent less alginate with less sodium better taste and fewer side effects than the current formula Astrup told Reuters Health. Alginate as an aid to weight loss is already commercially available in pill form and costs around for a sevenday supply. These supplements are not regulated by the Food and Drug Administration said Vazquez Roque. SOURCE bit.lyLSuLvS httpbit.lyLSuLvS American Journal of Clinical Nutrition online May ."

"Novartis will seek regulatory approval this year for a new kind of antiinflammatory heart drug though some experts fear fatal infection risks and a high price may overshadow the medicines limited benefits. FILE PHOTO A general view shows the Rhine river and the headquarters of Swiss pharmaceutical company Novartis AG in Basel Switzerland March . REUTERSArnd Wiegmann Keenly awaited clinical trial results released on Sunday showed heartattack survivors on one of three doses of canakinumab were percent less likely to suffer another major cardiac event than those on a placebo. Novartis had said in June that the drug met its goal in the study but details were only unveiled at European Society of Cardiology meeting in Barcelona. One leading expert described the benefit as modest. Patients getting canakinumab also suffered significantly more deaths from infections than those on placebo but on the positive side they appeared to be at lower risk of cancer. There was no significant difference in the rate of deaths from all causes between the placebo group and those on canakinumab. The modest absolute clinical benefit of canakinumab cannot justify its routine use in patients with previous myocardial infarction until we understand more about the efficacy and safety tradeoffs and unless a price restructuring and formal costeffectiveness evaluation supports it wrote Dr. Robert Harrington chair of the Stanford University School of Medicine in an editorial in the New England Journal of Medicine. Canakinumab had stirred considerable scientific interest because it appears to finally deliver proof that fighting inflammation offers a promising new way to counter heart disease in patients who already get cholesterollowering treatment. Subsequently some analysts boosted their revenue estimates for the Novartis medicine into the billions of dollars while awaiting the data announced on Sunday. Canakinumab is already approved as Ilaris for rare autoimmune conditions. Vas Narasimhan Novartiss head of global drug development said the drugmaker plans to go to regulators in the fourth quarter to seek approval for canakinumab to treat heartattack victims with high levels of inflammation. He downplayed critics who said the benefit was small saying that one large subgroup in the socalled Cantos trial had shown a percent reduction in cardiovascular risk. Novartis also plans to underscore canakinumabs potential cancer fighting properties with the European Medicines Agency and the U.S. Food and Drug Administration. SEPARATE TRIALS Thats after an analysis of Cantos data found total cancer mortality among patients getting canakinumab was significantly lower than in those receiving the placebo. Narasimhan who said the company now plans to start separate cancer trials for canakinumab said the drug could be particularly suitable for smokers with risks of both lung cancer and heart problems. With the oncology findings promising but only preliminary the company is planning additional studies in lung cancer starting next year he said. Ilaris now costs about per patient annually for treating rare immune conditions and brings in some million in yearly sales for the Swiss company though its price is likely to be slashed should it win approval in the heart setting. Novartis initially struggled with the sluggish launch of its last heart drug the peryear Entresto so it is understandably concerned about the reception for canakinumab. While Narasimhan said it was too early to discuss pricing he argued socalled PCSK cholesterol drugs that cost about annually should not be relied on as a yardstick. In view of the additional oncology findings we dont think you should just think about this as a cardiovascular drug Narasimhan said. I dont think you can necessarily just make comparisons to existing benchmarks such as the PCSKs. Even so Tim Anderson a Bernstein analyst said the marginal data are not compelling enough to dispel what for Novartis will remain a pricing conundrum should canakinumabs approval be expanded for heart patients. If the company cuts the price of the product in its current orphan indications then it instantly sacrifices sales which currently total about million per year with the hope that future sales in a new CV setting will more than offset this Anderson said in a note. Some have wondered whether a particularly highrisk subgroup could be identified where canakinumabs current price can be justified he said. We are not hopeful here. Reporting by John Miller Editing by Ben Hirschler and Ralph Boulton Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"The very high levels of vitamin D that are often recommended by doctors and testing laboratories and can be achieved only by taking supplements are unnecessary and could be harmful an expert committee says. It also concludes that calcium supplements are not needed. The group said most people have adequate amounts of vitamin D in their blood supplied by their diets and natural sources like sunshine the committee says in a report that is to be released on Tuesday http For most people taking extra calcium and vitamin D supplements is not indicated said Dr. Clifford J. Rosen http a member of the panel and an osteoporosis expert at the Maine Medical Center Research Institute. Dr. J. Christopher Gallagher director of the bone metabolism unit at the Creighton University School of Medicine in Omaha Neb. agreed adding The onus is on the people who propose extra calcium and vitamin D to show it is safe before they push it on people. Over the past few years the idea that nearly everyone needs extra calcium and vitamin D especially vitamin D httpwell.blogs.nytimes.comthemiracleofvitamindsoundscienceorhype has swept the nation. With calcium adolescent girls may be the only group that is getting too little the panel found. Older women on the other hand may take too much putting themselves at risk for kidney stones. And there is evidence that excess calcium can increase the risk of heart disease the group wrote. As for vitamin D some prominent doctors have said that most people need supplements or they will be at increased risk for a wide variety of illnesses including heart disease cancer and autoimmune diseases. And these days more and more people know their vitamin D levels because they are being tested for it as part of routine physical exams. The number of vitamin D tests has exploded said Dennis Black a reviewer of the report who is a professor of epidemiology and biostatistics at the University of California San Francisco. At the same time vitamin D sales have soared growing faster than those of any supplement according to The Nutrition Business Journal httpnutritionbusinessjournal.comsupplementsnewsvitamindomegafishoilfocusnewmilliondollarstudy. Sales rose percent from to reaching million. Everyone was hoping vitamin D would be kind of a panacea Dr. Black said. The report he added might quell the craze. I think this will have an impact on a lot of primary care providers he said. The member expert committee was convened by the Institute of Medicine http an independent nonprofit scientific body at the request of the United States and Canadian governments. It was asked to examine the available data nearly publications to determine how much vitamin D and calcium people were getting how much was needed for optimal health and how much was too much. The two nutrients work together for bone health. Bone health though is only one of the benefits that have been attributed to vitamin D and there is not enough good evidence to support most other claims the committee said. Some labs have started reporting levels of less than nanograms of vitamin D per milliliter of blood as a deficiency. With that as a standard percent of the population would be deemed deficient of vitamin D Dr. Rosen said. Most people need to take supplements to reach levels above nanograms per milliliter he added. But the committee concluded a level of to nanograms is all that is needed for bone health and nearly everyone is in that range. Vitamin D is being added to more and more foods said Paul R. Thomas httpods.od.nih.govAboutPaul_Thomas.aspx of the Office of Dietary Supplements at the National Institutes of Health httpods.od.nih.gov. Not only is it in orange juice and milk but more is being added to breakfast cereals and it now can be found in very high doses in supplement pills. Most vitamin D pills he said used to contain no more than international units of it. Now it is easy to find pills even in places like WalMart with international units. The committee though said people need only international units a day. To assess the amounts of vitamin D and calcium people are getting the panel looked at national data on diets. Most people they concluded get enough calcium from the foods they eat about milligrams a day for most adults for women ages to . Vitamin D is more complicated the group said. In general most people are not getting enough vitamin D from their diets but they have enough of the vitamin in their blood probably because they are also making it naturally after being out in the sun and storing it in their bodies. The American Society for Bone and Mineral Research http and other groups applauded the report. It is a very balanced set of recommendations said Dr. Sundeep Khosla a Mayo Clinic endocrinologist and the societys president. But Andrew Shao an executive vice president at the Council for Responsible Nutrition https a trade group said the panel was being overly cautious especially in its recommendations about vitamin D. He said there was no convincing evidence that people were being harmed by taking supplements and he said higher levels of vitamin D in particular could be beneficial. Such claims are not supported by the available evidence the committee wrote. They were based on studies that observed populations and concluded that people with lower levels of the vitamin had more of various diseases. Such studies have been misleading and most scientists agree that they cannot determine cause and effect. It is not clear how or why the claims for high vitamin D levels started medical experts say. First there were two studies which turned out to be incorrect that said people needed nanograms of vitamin D per milliliter of blood the upper end of what the committee says is a normal range. They were followed by articles and claims and books saying much higher levels to nanograms or even higher were needed. After reviewing the data the committee concluded that the evidence for the benefits of high levels of vitamin D was inconsistent andor conflicting and did not demonstrate causality. Evidence also suggests that high levels of vitamin D can increase the risks for fractures and the overall death rate and can raise the risk for other diseases. While those studies are not conclusive any risk looms large when there is no demonstrable benefit. Those hints of risk are challenging the concept that more is better the committee wrote. That is what surprised Dr. Black. We thought that probably higher is better he said. He has changed his mind and expects others will too I think this report will make people more cautious."

"Women who need breast surgery to remove an abnormality that cannot be felt also known as a nonpalpable breast lesion now may benefit from the convenience and comfort provided by an advanced new tissue locating technology offered at Rush University Medical Center. The SAVI SCOUT Radar Localization System helps to decrease the time a woman is in the operating room increase the success rates of lesion removal and reduce the amount of healthy breast tissue that is removed during the procedure. Rush began offering SAVI SCOUT which has been used in more than lumpectomy surgeries in July. SAVI SCOUT allows a radiologist to insert a radar wave reflector the size of a grain of rice in the patients breast up to days before surgery to mark the location of the lesion as shown with ultrasound or Xray https mammography https The reflector replaces the widespread current practice of inserting a thin hooked wire into the breast the same day as surgery. When there is an abnormality that we cant feel and are unable to biopsy we have to find that lesion in surgery said Dr. Andrea Madrigrano httpsdoctors.rush.edudetails assistant professor of surgery at Rush University Medical Center. SAVI SCOUT replaces a more inconvenient technique used since s Used since the s a hooked wire is placed in the breast through the skin to the abnormality using ultrasound or Xray guidance with local anesthesia. The wire is placed into the breast to help guide the surgeon in removing the abnormality later that day. Until now a patient would go to the imaging center to have the thin wire precisely placed in the breast. The woman would then be taken to the operating room area Madrigrano said. Wire localization requires a high degree of coordination between radiology and surgical scheduling which can lead to delays between placement of the wire and surgery often requiring a woman to wait long periods of time with the wire in her breast. Before surgery these patients are in a hospital gown and are walking around while this wire is in place which obviously is less than ideal for the patient Madrigrano said. The radar reflector is a replacement for the wire and is essentially a little marker. After the patient receives a local anesthetic it can be placed into the breast using an extremely thin needle under image guidance days or weeks prior to surgery. Because this important step is out of the way in advance it completely changes the patients day of surgery experience. Radar can target abnormality within mm sparing more healthy tissue Unlike mastectomy https which treats breast cancer by removing an entire breast lumpectomy https surgery also known as breastconserving surgery is used to remove only the tumor and a small amount of tissue surrounding the tumor. Using the SAVI SCOUT system technology which emits million radar pulses per second surgeons can target the affected tissue within millimeter of the reflector. When Madrigrano told me about it I thought it was an ingenious idea and Im glad it was developed said Nancy Morrissey who underwent lumpectomy surgery at Rush in July using the SAVI SCOUT technology. It made surgery go smoothly and I didnt have any pain before or after. When the marker was inserted near the lump it was similar to a biopsy. I was glad it was done a week before and not the same day as the lumpectomy surgery. I have been very impressed with the experience. According to Cianna Medical the company that created SAVI SCOUT percent of women return to work the next day after the SCOUT procedure. In addition to enhancing the patients surgical experience the more precise localization of the surgical site enable surgeons to plan the procedure better. That advantage may lead to less tissue needing to be removed and a better appearance of the breast after surgery. Ultimately this wireless technology has the potential to reduce surgical delays and more importantly will benefit patients by increasing comfort and satisfaction during a stressful time Madrigrano said."

"People who practice the meditative technique called mindfulness meditation https may be able to reduce the symptoms of irritable bowel syndrome https IBS https a new study shows. The study found that the physical and psychological symptoms of IBS https were more effectively managed by people practicing mindfulness meditation than in support group therapy. Susan Gaylord PhD of the University of North Carolinas program on integrative medicine https set out to evaluate mindfulness meditation as a therapeutic technique for IBS https because it has been reported to improve symptoms in other chronic conditions such as depression https and fibromyalgia https In a study of women between the ages of and participants were placed in a mindfulness meditation group or a comparison group that offered mutual support for IBS and lifes problems. Each group took an eightweek course that included weekly sessions and a halfday retreat. After the end of the eightweek period overall IBS severity was reduced more among patients in the mindfulness meditation group compared to the support group . vs. .. After a threemonth followup . of those in mindfulness meditation reported a reduction in severity of IBS symptoms https compared with only . who said that among patients who took part in the support group therapy. Mindfulness Meditation and IBS Symptoms Changes in qualityoflife impairment anxiety https and psychological distress were not significantly different after the eightweek period. But all were much improved at the threemonth followup in the meditation group. Our study indicates that mindfulness meditation is a practical widely applicable and inexpensive method to enable irritable bowel syndrome patients to improve their clinical outcomes and gain associated improvement in wellbeing says Olafur S. Palsson PsyD a licensed clinical psychologist https and one of the researchers. Palsson an associate professor of medicine at the University of North Carolina Chapel Hill says this method can be learned in educational classes without the need for clinical therapists for longterm use. In an abstract he defines mindfulness meditation as a behavioral technique that involves attending intentionally to presentmoment experience and nonjudgmental awareness of body sensations and emotions while letting go of fixation of thoughts of past and future. Though mindfulness meditation seems to work the exact method of how it works is not known the researchers say and more investigation is planned. This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the peer review process in which outside experts scrutinize the data prior to publication in a medical journal."

"A surgical technique called EDAS encephaloduroarteriosynangiosis significantly decreases the rate of stroke recurrence and death for patients with severe atherosclerosis of the brain arteries according to findings of a Phase IIa clinical trial presented today at the World Stroke Congress in Montreal. Atherosclerotic disease in which plaque buildup narrows the brain arteries is one of the most common causes of strokes https Neurosurgeons performing EDAS reroute arteries from the scalp and the membranes that cover the brain and place these arteries under the skull near areas of the brain at risk of stroke. Over time new blood vessels form creating fresh pathways for blood and oxygen to reach the brain. The trial led by Nestor R. Gonzalez MD httpbio.csmc.eduviewNestorGonzalez.aspx professor of Neurosurgery and director of the Neurovascular Laboratory at CedarsSinai enrolled patients with severe brain atherosclerosis also known as intracranial atherosclerotic disease or ICAD who showed symptoms of either a recent stroke or a ministroke called a transient ischemic attack https These patients received EDAS surgery along with intensive medical management which included diet and lifestyle changes blood thinners and other medications to control blood pressure cholesterol and blood sugar levels. After one year . percent of the patients treated with the surgery experienced another ischemic stroke or died compared with . percent of patients in a matched control group who received only intensive medical management. Two of the EDAS patients had small wound openings that required additional surgical interventions but there were no intracranial hemorrhages or other serious adverse events the researchers reported. Our findings in this intermediatestage trial are promising for applying EDAS surgery to intracranial atherosclerotic disease said Gonzalez said. Previously EDAS has been used for moyamoya disease a rare cerebrovascular disorder that affects younger patients. Gonzalez said the new trial addressed a serious medical need. Even under the best current treatments ICAD carries high rates of recurrent stroke and death compared with other causes of stroke he said. Developing new therapeutic strategies is crucial for ICAD patients. Current ICAD therapiesin addition to intensive medical managementinclude bypass surgery to connect a blood vessel from outside the brain to a vessel inside the brain as well as angioplasty with stenting which involves inflating a tiny balloon inside a cerebral artery to open it up and placing a stent device inside the artery. Despite advances in medical care annual rates of recurrent stroke and death are remain high at percent or more for ICAD patients according to published research. Gonzalez said his team is working with the stroke prevention working group of the National Institutes of Health to develop a proposal for a Phase III randomized clinical trial across multiple institutions to further test the effectiveness of EDAS as compared with intensive medical management. While this Phase IIa trial selected patients from previous studies as the control group the Phase III study would enroll new ICAD patients for both the control and experimental groups he explained. This clinical trial moves us significantly closer to preventing strokes and death in highrisk populations said Keith Black MD httpbio.csmc.eduviewblack.aspx professor and chair of the Department of Neurosurgery. As a nationally renowned physicianinvestigator Dr. Gonzalez personifies the dedication of CedarsSinai to translating the most advanced research into new cures. Besides Gonzalez the trial involved other investigators from the stroke centers https of CedarsSinai and UCLA. Funding Research reported in this publication was supported by the National Institutes of Neurological Disorders and Strokes of the National Institutes of Health under award number KNSA."

"The US Food and Drug Administration has for the first time approved https a blood test to help detect concussion in adults. The Brain Trauma Indicator test measures two biomarkers proteins known as UCHL and GFAP that are released upon injury to the brain and pass through the bloodbrain barrier. Elevated levels of the proteins can be detected within or minutes of injury. The test can be taken within hours of injury and results can be obtained within three or four hours. Patients are currently diagnosed with concussion based on a combination of symptoms as well as imaging. However CT scans dont always detect concussion. Over of CT scans for concussion are negative. And you get times the radiation of a chest Xray. Its expensive its not terrific said Hank Nordhoff chairman and CEO of Banyan Biomarkers maker of the new test. It can help determine whether a patient further needs a CT scan based on a physicians concerns. Todays action supports the FDAs Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging an effort to ensure that each patient is getting the right imaging exam at the right time with the right radiation dose FDA Commissioner Dr. Scott Gottlieb said in a statement Wednesday. The test could also help reduce costs significantly. Where a CT scan can cost to Nordhoff predicts that the new test would cost closer to . The test would be available to hospitals Nordhoff said and he hopes a handheld sideline device could be commercially available in the near future. The FDA approved the test as part of its breakthrough devices program after evaluating a clinical study of blood samples from people thought to have concussion or mild traumatic brain injury. The clinical trials did not include any children though Banyan plans to include them in future studies. When compared with a CT scan the blood test was . as effective in detecting concussion and . effective in ruling out concussion. A blood test that accurately reliably and consistently detects the presence of brain proteins that appear in the blood after a brain injury is a major advance said Dr. David Dodick a fellow of the American Academy of Neurology who specializes in sports medicine and neurology. He was not involved in the development of the test. Though Dodick was optimistic about the blood test he said a lot of work still needs to be done in understanding and diagnosing brain injury. He pointed out that we need better measurements to understand when brains have fully healed from trauma as well as a better understanding of how these biomarkers act which may actually affect prognosis. Its also unknown how this test can determine subconcussive hits hits that dont cause symptoms but do cause a brain injury he explained. These occur much more often than actual concussions especially in certain collision and contact sports. Subconcussive or repeated hits to the head are believed to be the root of the neurodegenerative disease chronic traumatic encephalopathy or CTE. In fact Banyan has partnered with another company Quanterix to help develop a test that could eventually detect the impact of repeated hits. Quanterix aims to combine the biomarkers with Banyan with digital technology that can look at the proteins at a super microscopic level and pinpoint low level concentrations of the proteins. The key now is to use this sensitivity to evolve in more brain health and to protect athletes and keep soldiers out of harms way said Kevin Hrusovsky president and CEO of Quanterix. Follow CNN Health on Facebook and Twitter See the latest news and share your comments with CNN Health on Facebook https and Twitter httpstwitter.comcnnhealth. The FDA believes that using the new blood test imaging can be avoided in at least a third of patients who are suspected of having a concussion. According to the US Centers for Disease Control and Prevention there were approximately . million incidents involving traumatic brain injury emergency department visits hospitalizations and deaths in ."

"Researchers have discovered a new class of drug that has the potential to help cancer patients who no longer respond to existing therapies. The drug may not become available to patients for a number of years yet but researchers believe that if clinical trials are successful it could be used to tackle a variety of treatmentresistant cancers. Patients with breast cancer for example frequently become resistant to existing hormonebased treatments leading to the disease becoming fatal. In a bid to come up with new forms of treatment that work in a distinct way from established ones chemists biologists and clinicians at Imperial College London collaborated on creating a new drug the properties of which are reported in the journal Molecular Cancer Therapeutics. The team of scientists at Imperial was funded by Cancer Research UK. The drug was then developed by Imperial in collaboration with Emory University in the USA. Early labbased tests of ICEC were successful in targeting resistant breast cancers and indicated minimal side effects. ICEC was then licenced to Carrick Therapeutics who developed it into a molecule named CT which they have taken to earlystage clinical trials in less than two years. The first patient was given the drug in November as part of Carricks a Phase I clinical trial to assess its safety and how well it can be tolerated. The trial is still ongoing so results are not available yet. Professor Charles Coombes from the Department of Surgery Cancer said Treatmentresistant tumours represent a significant threat for patients as once a cancer stops responding to treatments there is increasingly little clinicians can do. Drugs such as these could help to shift the balance back in favour of the patients potentially providing a new option to patients for who existing treatments no longer work. Professor Tony Barrett from the Department of Chemistry said This work is the result of extensive collaboration between chemists biologists and clinicians which has helped to bring a new treatment from discovery to clinical testing in record time streamlining the process. The drug targets an enzyme called CDK involved in directing cells through their lifecycle which consists of growth DNA replication and cell division. CDK is also involved in the process of transcription a vital step in gene expression the creation of proteins to carry out cell functions. Particular cancers such as treatmentresistant breast cancers have a unique dependence on transcription meaning targeting CDK may be particularly effective. By inhibiting transcription ICEC shuts down the ability of the cancer to spread. As well as breast cancers cancers such as acute myeloid leukaemia and smallcell lung cancer are particularly transcriptiondependent so ICEC may work well for these too especially where they have become resistant to other treatments. The discovery of the drug was spurred by an initial meeting between Professor Anthony Barrett from the Department of Chemistry and oncologist Professor Charles Coombes from the Department of Surgery Cancer. Professor Simak Ali also from the Department of Surgery Cancer was working on understanding the action of CDK in treatmentresistant breast cancer. Professors Coombes and Ali suggested CDK as a drug target leading the collaboration to attempt to design a molecule that would inhibit its action. From early attempts a large collaborative team was eventually founded for drug discovery from bench to bedside directed by Dr Matthew Fuchter in the Department of Chemistry. Possible compounds for CDK inhibition were modelled using computational drug design aided by collaboration with Emory University. Ultimately a candidate molecule called ICEC suppressed tumour growth in a wide range of cancer types in lab tests. In addition laboratory studies showed ICEC worked better in combination with traditional hormone therapies for estrogen receptor positive breast cancer cells which have not yet become resistant. It is this molecule in oral pill form that was taken forward by Carrick as CT and is currently in Phase I clinical trials. If the Phase I trial proves successful the compound must pass further stages of trial over the next few years before it becomes available to patients. Early funding for the study came from the Engineering and Physical Sciences Research Council EPSRC and a major contribution of wholeproject funding was from Cancer Research UK. Licensing of the technology to Carrick Therapeutics was led by Cancer Research UKs Commercial Partnerships Team and Imperial Innovations the Technology Transfer Office of Imperial with support from Emory University. Dr Iain Foulkes Cancer Research UKs executive director of research and innovation said Its exciting to see how Cancer Research UKs partnerships with both academia and industry are bringing urgently needed new tests and treatments to patients. Drug resistance continues to be a major challenge across many cancer types so its vital that we explore new ways to tackle tumours that have stopped responding to standard therapies. We hope that this promising new class of drug will offer more options to patients who have few left available to them and help more people survive their cancer."

"A new class of drugs called HIF inhibitors is more effective and better tolerated than the standard of care drug sunitinib in treating kidney cancer researchers with the Kidney Cancer Program at Harold C. Simmons Comprehensive Cancer Center have found. HIF inhibitors which grew out of research begun more than years ago at UT Southwestern Medical Center work by interfering with processes that fuel the growth of cells. Investigators conducted a preclinical trial in mice transplanted with kidney cancer from over patients and showed that the HIF inhibitor PT controlled cancer in half of the tumors according to a study published in the journal Nature. This is a completely new treatment for kidney cancer. We want to make HIF inhibitors available to patients and are currently carrying out clinical trials said Dr. James Brugarolas Director of the Kidney Cancer Program who is leading an million SPORE grant from the National Cancer Institute seeking to translate new discoveries into novel therapies for kidney cancer patients. Part of the SPORE grant one of just two directly related to kidney cancer in the nation is focused on further researching HIF inhibitors. In a previous report Dr. Kevin Courtney Assistant Professor of Internal Medicine and a coauthor of the current study reported at the American Association of Clinical Oncology annual meeting that HIF inhibitors were safe in patients and had activity even in heavily pretreated patients. In the study in Nature investigators show that HIF inhibition was able to control metastatic kidney cancer even after lines of prior therapy. See video. The findings show that HIF is a promising target to combat kidney cancer said Dr. Brugarolas senior author and a Virginia Murchison Linthicum Scholar in Medical Research at UT Southwestern. Nearly Americans are now living with a diagnosis of kidney cancer and more than people are expected to be diagnosed with kidney cancer this year according to the National Cancer Institute. Texas has the fifth highest rate of this cancer in the U.S. What is HIF HIFs or hypoxiainducible factors like HIF allow the bodys cells to adjust to lowoxygen environments. HIFs activate programs that promote the development of blood vessels facilitate oxygen delivery and promote efficient nutrient utilization. Kidney cancer cells hijack the same system to fuel their growth. HIF inhibitors work by suppressing the effects of HIF which include downregulating an important protein called VEGF that promotes the formation of blood vessels needed for tumors to grow. Unlike existing VEGF inhibitors the HIF inhibitor blocks VEGF only in the cancer and therefore does not cause cardiac toxicity or hypertension Dr. Brugarolas explained. New HIF findings In the Nature study researchers compared the two drugs head to head and found that the HIF inhibitor was more active than sunitinib and that it was active against tumors progressing on sunitinib. Furthermore it was also better tolerated. As sometimes happens in patients mice on sunitinib were sickly and lost weight whereas mice on the HIF inhibitor gained weight while on the study he said. Researchers surprisingly found a subset of tumors that do not respond to the drug but were able to identify biomarkers that once verified would help determine which patients are more likely to benefit from HIF therapies. HIF is believed to be the most important driver of kidney cancer. Traditionally proteins like HIF were disregarded as drug targets because their shape made it nearly impossible to design drugs against them Dr. Brugarolas said. The approaches we have taken pave the way for identifying drug candidates for other proteins that have traditionally been considered undruggable. HIF also appears significant in other types of cancer including deadly brain cancers called glioblastomas and nonsmall cell lung cancer the most common type of lung malignancy. How HIF came to be In UT Southwestern researchers Dr. Steven McKnight Chairman of Biochemistry and molecular geneticist Dr. David Russell Vice Provost and Dean of Basic Research led research discovering and describing the protein encoded by the EPAS gene also known as HIFa the main HIF component. Over the course of a decade the laboratories of Dr. Richard Bruick Professor of Biochemistry holder of the Michael L. Rosenberg Scholar in Biomedical Research and a coauthor of the current study and Dr. Kevin Gardner Adjunct Professor of Biochemistry solved the structure of HIFa. By researchers had identified a sweet spot where drugs could bind and shut down HIF activity. Using the Simmons Cancer Centers HighThroughput Screening scientists tested more than chemicals to see which ones could interfere with HIF identifying several potential druglike compounds. The most promising compounds were licensed to Peloton Therapeutics Inc. a biotech firm cofounded by Dr. McKnight and based at UT Southwesterns BioCenter campus. In the first HIF inhibitor an oral drug known as PT entered clinical trials in patients with advanced or metastatic renal clear cell carcinoma. HIF inhibitors also are the target of UTSWs recent million SPORE Specialized Program of Research Excellence award. Investigators will further biomarkers to identify patients most likely to respond to the HIF inhibitor as well as to anticipate ways in which the tumor may evade the drugs impact. UT Southwesterns SPORE program involves four innovative disease and clinical research teams targeting adult and pediatric kidney cancer. Other UTSW SPORE investigators are looking at the function of a gene that identifies a cluster of particularly aggressive tumors in hopes of identifying vulnerabilities that can be targeted with drugs examining kidney cancer metabolism to distinguish aggressive from less active tumors potentially yielding a tailored treatment approach and evaluating novel subtypes of childhood kidney cancer. The HIF research team The Nature research was supported by grants from the National Institutes of Health including the SPORE Peloton Therapeutics Inc. and the Cancer Prevention and Research Institute of Texas the National Center for Advancing Translational Sciences Center for Translational Medicine National Natural Science Foundation of China and philanthropy including the Tom Green Memorial fund. More than researchers contributed to the study including Dr. Payal Kapur Associate Professor of Pathology Dr. Ivan Pedrosa Associate Professor of Radiology in the Advanced Imaging Research Center who holds the Jack Reynolds M.D. Chair in Radiology Dr. Xiankai Sun Associate Professor of Radiology in the Advanced Imaging Research Center who holds the Dr. Jack Krohmer Professorship in Radiation Physics Dr. XianJin Xie Professor of Clinical Sciences Dr. Yang Xie Associate Professor of Clinical Sciences Dr. Tae Hyun Hwang Assistant Professor of Clinical Sciences Dr. Guiyang Hao Assistant Professor of Radiology Dr. Eugene Frenkel Professor of Internal Medicine and Radiology who holds the Raymond D. and Patsy R. Nasher Distinguished Chair in Cancer Research in Honor of Eugene P. Frenkel M.D. the Elaine Dewey Sammons Distinguished Chair in Cancer Research in Honor of Eugene P. Frenkel M.D. and the A. Kenneth Pye Professorship in Cancer Research and Dr. Rene M. McKay Director of Research Administration for the Kidney Cancer Program. Additional UT Southwestern researchers include lead authors Dr. Wenfang Chen Haley Hill Alana Christie and Min Soo Kim as well as Eboni Holloman Andrea PaviaJimenez Farrah Homayoun Dr. Yuanqing Ma Dr. Nirav Patel Dr. Guiyang Hao Qurratulain Yousuf Allison Joyce Dr. He Zhang and Jenny Chang. Disclosures coauthors Tai Wong James P. Rizzi Eli M. Wallace Naseem Zojwalla and John A. Josey are employees and own equity in Peloton Therapeutics Inc. Kevin Gardner and Richard Bruick have licensed IP consult for and own equity Min Soo Kim Tae Hyun Hwang Yang Xie and James Brugarolas are authors on a filed patent pertaining biomarkers of the HIF inhibitor. UT Southwestern Medical Center owns stock in Peloton Therapeutics and has a financial interest in the intellectual property used within the research. The Harold C. Simmons Comprehensive Cancer Center is the only NCIdesignated comprehensive cancer center in North Texas and one of just NCIdesignated comprehensive cancer centers in the nation. Simmons Cancer Center includes major cancer care programs. In addition the Centers education and training programs support and develop the next generation of cancer researchers and clinicians. Simmons Cancer Center is among only U.S. cancer research centers to be designated by the NCI as a National Clinical Trials Network Lead Academic Participating Site. About UT Southwestern Medical Center UT Southwestern one of the premier academic medical centers in the nation integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty includes many distinguished members including six who have been awarded Nobel Prizes since . The faculty of almost is responsible for groundbreaking medical advances and is committed to translating sciencedriven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in about specialties to more than hospitalized patients and oversee approximately . million outpatient visits a year."

"Three longawaited studies have shown that mechanically removing a blood clot from a stroke patients brain is no more useful than the older treatment of giving an IV dose of a clotdissolving drug to the whole body. The results of the clinical trials presented this week at a meeting in Hawaii shocked and surprised stroke physicians. Many had already adopted the more aggressive strategy over the past decade. For the stroke field this is a really big deal Walter Koroshetz deputy director of the National Institute of Neurological Disorders and Stroke said of the findings which were presented over three days at the International Stroke Conference in Honolulu. NINDS paid for two of the trials one of which cost million. One study took eight years to complete because it was so difficult to enroll patients willing to take the chance that they would be randomly assigned to get the older treatment. Practitioners hoped that endovascular treatment in which a catheter is threaded into a blocked artery and the clot pulled out would do for stroke patients what it has done for heart attack patients. In them going after clots with angioplasty balloons and stents is clearly more effective than giving clotdissolving drugs through a vein in the arm. We did this study with the strong expectation that we would find a positive benefit. We were surprised said Joseph P. Broderick of the University of Cincinnati Neuroscience Institute who headed one of the studies. His view was echoed by Alfonso Ciccone a neurologist from Milan who led a clinical trial in Italy We were surprised. We wanted the superiority of endovascular treatment. Whether the findings will cause physicians to abandon the practice is uncertain. Insurance companies and Medicare the health insurer for the elderly already cover the endovascular procedure. It costs about compared with for acute stroke treatment using intravenous clotdissolving drugs known as thrombolytics. Further many practitioners think that newer clotretrieving devices work better than the ones used in the three trials. Because endovascular procedures were shown to be no more dangerous than IV thrombolytics physicians may continue to perform them and assume the outcomes can only get better. Will it change practice Thats a good question said Koroshetz. The payers may look at this and wonder if they should continue paying for these procedures. If it gets to that point then clearly things will change. Stroke is the fourthleading cause of death in the United States. About people http a stroke each year and about die. Nearly percent of strokes occur when a clot blocks an artery in the brain starving the region downstream of blood and oxygen. If flow isnt restored quickly brain tissue and the functions it controls movement speech cognition are damaged or can die. Over the past years studies showed that if a person having a stroke gets a thrombolytic drug within three hours of when the symptoms start hours for certain patients the process can be reversed and a lifetime of disability avoided. Later than that little is gained the brain cells are too damaged to survive. In fact giving the drugs too late can make matters worse. Uncontrolled bleeding can occur as the dying tissue breaks down. Early observations suggested that approaching the clot with a catheter and either injecting clotdissolving drugs into it or snagging it and pulling it out produced better results. In the FDA began approving use of the catheters http_embolectomy_for_treatment_of_acute_stroke.pdfin the brain because they had been proved useful elsewhere in the body. The three studies reported this week which will eventually be published in the New England Journal of Medicine tested the hypothesis in a rigorous way. In the largest trial called IMS III all patients got the IV clotdissolving drug tPA within three hours of the start of stroke symptoms. Half were then assigned to get an imaging study that looked at the arteries of the brain to see whether a blockage remained. If it did the doctors went after it with an endovascular procedure. The other half of the patients got standard treatment which didnt include the procedure. Fortyone percent of patients recovered completely in the endovascular group and percent recovered completely in the control group outcomes that were no different statistically. Death within three months was essentially the same too percent vs. percent. In the Italian study called SYNTHESIS Expansion stroke patients were randomly assigned to get either IV tPA or endovascular treatment. At three months percent of the patients in the tPA group were alive without any disabilities compared with percent of the endovascular group. That also was not significantly different. The third study called MR RESCUE run out of Georgetown University was more complicated. It randomly assigned patients less than eight hours out from the start of their strokes to receive standard care or have the clot removed with a catheter device. They also got CAT or MRI scans to see whether they had a large or small amount of brain tissue still alive and salvageable. Removing the clot wasnt better than standard care in either group those with a lot or a little brain tissue to lose. I think everybody was a little surprised. But mainly disappointed said Chelsea S. Kidwell the Georgetown neurologist who headed the study. Why endovascular treatment wasnt better is a mystery that the researchers are struggling to explain. The answer could be in the patients the device or the timing of the procedure. In IMS III patients with large strokes benefited from clot removal more than those with small ones but there werent enough patients in the study to make such a fine distinction with certainty. Its a hint. But its not proof Broderick said. In MR RESCUE only percent of arteries opened up completely after the clot was grabbed. Current devices which use a mesh stent to hold the clot more firmly are successful more than percent of the time. The stroke community is hopeful that with the new generation devices we will show better outcomes Kidwell said. In the Italian study patients getting endovascular treatment were . hours into their stroke an hour longer than those getting IV treatment because of the logistics of assembling the procedure team. That hour could have made a difference. We know that time is brain Ciccone said. The three trials demonstrated how hard it is to test things once theyre in widespread use. History is replete with treatments such as supplemental oxygen for premature infants http and devices such as pulmonary artery catheters http used routinely before being shown to be harmful or of little value. It took from to for the MR RESCUE team to recruit the patients in the trial. It had permission to run the study in hospitals but found only that were willing to participate. More than other hospitals were invited to join but declined because their neurologists were already convinced the catheter treatment was better a view that turns out not to be true."

"Palbociclib a new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy also has potential to combat other types of cancer according to a literature review and additional original research httponcology.jamanetwork.comarticle.aspxarticleid conducted by experts at the Abramson Cancer Center ACC in the University of Pennsylvania published this month in JAMA Oncology. Palbociclib targets the rapid division of tumor cells by inhibiting the activity of the enzymes CDK and CDK which propel cell division and increase in number in most cancers. It is the first CDK inhibitor to be approved for the treatment of breast cancer. All living cells undergo cell division and palbociclibs unique capacity to halt the cell division process also known as the cell cycle therefore has potentially broad applicability said the studys lead author Amy S. Clark MD MSCE an assistant professor of HematologyOncology at Penns Perelman School of Medicine and ACC. Pairing palbociclib with other anticancer therapies such as endocrine therapy chemotherapy and targeted therapy can create a powerful combinatorial effect with real promise for addressing a variety of cancers. For example amplification of CDK is reported in a high percentage of melanomas and esophageal cancers. Targeted therapy uses medication and other interventions to more accurately identify and attack cancer cells usually while doing no or little damage to normal cells. This drug has minor effects on normal cells other than neutrophils white blood cells said the studys senior author Peter J. ODwyer MD a professor of HematologyOncology at Penn and director of the Developmental Therapeutics Program at the ACC. In tumors it can cause shrinkage or more commonly arrest of growth. As we discover new functions for the CDK target of this medicine we are likely to use it in combinations to make other anticancer agents work better. In addition to inhibiting the cell cycle palbociclib has been shown for example to alter several recently described noncell cycle functions of CDK a finding expected to expand its therapeutic role ODwyer added. Assessing relevant publications in the literature as well as interpreting their own continuing studies the allPenn team found that in addition to its safety and effectiveness in fighting certain types of breast cancer early trials of palbociclib have shown promise of effectiveness in cases of lymphoma sarcoma and teratoma tumors that while rare often afflict younger patients. A phase trial showed that among patients with previously treated mantlecell lymphoma palbociclib resulted in one complete response and two partial responses. Although median progressionfree survival was four months five patients had progressionfree survival greater than one year. Another phase trial with sarcoma patients treated with palbociclib showed a progressionfree survival of percent at weeks. Also combining palbociclib with other anticancer agents is feasible and early results in myeloma and some solid tumors have led to more definitive studies. In both breast and other cancer trials palbociclib has been shown to be safe with oncedaily dosing and its main adverse effect is reversible neutropenia an abnormally low count of neutrophils a type of white blood cell that helps fight infections. The lower their neutrophil count the more vulnerable patients are to infectious diseases. In such cases the drug is temporarily discontinued and reintroduced at a lower dose. Other side effects included fatigue percent nausea percent diarrhea percent constipation percent and rash percent. At the recommended doses evidence of the desired drug effect in tumors has been obtained using novel PET imaging at Penn. These tools can help to individualize patient therapy going forward. Other Penn coauthors are Thomas B. Karasic MD Angela DeMichele MD MSCE David J.Vaughn MD Mark OHara MD Rodolfo Perini MD Paul Zhang MD Priti Lal MD Michael Feldman MD PhD and Maryann Gallagher RN. The study was funded by Pfizer Inc and the National Institutes of Health P CA."

"As a particularly nasty flu season rages across the United States scientists have found a powerful new disinfectant that makes light work of the virus. Researchers say a certain spectrum of ultraviolet light called farUVC easily kills airborne flu viruses while posing no risk to people. It could offer a new inexpensive way to eliminate airborne flu viruses in indoor public spaces such as hospitals doctors offices schools airports and aircraft said the team from Columbia University Medical Center in New York City. The disinfecting success of initial experiments still need to be confirmed said lead research David Brenner. But he believes the use of overhead lowlevel farUVC light in public locations would be a safe and efficient method for limiting the transmission and spread of airbornemediated microbial diseases such as influenza and tuberculosis. As the researchers explained broadspectrum UVC light kills viruses and bacteria and it is currently used to decontaminate surgical equipment. But this type of light can cause skin cancer and cataracts so its not used in public spaces. However Brenner and his colleagues wondered if a much narrower spectrum of ultraviolet light farUVC might be a safer option. In prior studies they found that farUVC light killed methicillinresistant S. aureus MRSA bacteria a common and dangerous superbug without harming human or mouse skin. In this new study they found that farUVC light also killed airborne HN virus a common strain of flu virus. FarUVC light has a very limited range and cannot penetrate through the outer deadcell layer of human skin or the tear layer in the eye so its not a human health hazard said Brenner who directs Columbias Center for Radiological Research. However because viruses and bacteria are much smaller than human cells farUVC light can reach their DNA and kill them he said in a university news release. Lamps with this type of UV light currently cost less than Brenner said but that price would likely fall if the lamps were massproduced. And unlike flu vaccines farUVC is likely to be effective against all airborne microbes even newly emerging strains he said. Two flu experts were encouraged by the findings. The prospect of reducing the transmission of influenza and other respiratory viruses using farUV radiation is very exciting said Dr. Michael Grosso chief medical officer at Huntington Hospital in Huntington N.Y. Though handwashing remains critically important it does not prevent every instance of transmission Grosso said. Immunization and antiviral medications are also important but again have limitations. It appears that lowdose farUV light is safe and effective and has the advantage of inactivating a wide range of diseasecausing viruses. Dr. Len Horovitz a pulmonary specialist at Lenox Hill Hospital in New York City agreed. He noted that the technologys cost is not prohibitive and it is safe. This use can sterilize the air in a public space reducing the spread of respiratory droplets containing flu viruses and other bacteria and viruses. The findings were published online Feb. in the journal Scientific Reports. More information The U.S. Centers for Disease Control and Prevention has more on flu https SOURCES Michael Grosso M.D. chair pediatrics and chief medical officer Huntington Hospital N.Y. Len Horovitz M.D. pulmonary specialist Lenox Hill Hospital New York City Columbia University Medical Center news release Feb."

"While the majority of morbidly obese patients who undergo gastric banding say they are generally satisfied years later almost percent are saddled with major complications while about half have to have their bands removed a small new Belgian study reveals. The finding comes on the heels of a recent study out of the University of California San Francisco that suggested gastric bypass surgery is superior to alternative surgical methods such as gastric banding for promoting weight loss andor eliminating type diabetes. The current observations stem from a research effort led by Dr. Jacques Himpens of the European School of Laparoscopic Surgery at the Saint Pierre University Hospital in Brussels whose team assessed the status of patients that had undergone the procedure known as laparoscopic adjustable gastric banding LABG more than a decade prior to the study launch. Himpens and his colleagues outline their findings in the March online issue and the July print issue of the Archives of Surgery. LAGB creates a small pouch by placing a constricting ring or band around the top portion of the stomach the smaller stomach size allows patients to feel full more quickly. Since its introduction in the banding approach has become a popular alternative to RouxenY gastric bypass surgery which involves the literal stapling of the stomach in order to redirect food past part of the small intestine to instigate reduced food absorption as well as a quicker sensation of satiety. But LAGB surgery has come under criticism in the past for involving a relatively high risk for complications including wound infection and injury to the spleen and esophagus and a poor prognosis in terms of longterm quality of life. It is also been reported that LAGB patients are likely to regain much of their lost weight years down the road. To explore satisfaction levels and the longterm complication history of gastric banding in Himpens and his team examined a pool of patients who had undergone the surgery between and . The results years or more later more than percent of the banding patients said they were satisfied with their experience. On average excess weight loss had been maintained at a level approaching nearly percent and quality of life appeared to be equal to that of patients who had not undergone the surgery. However percent of the patients had experienced serious complications including abnormal pouch expansion band erosion and band infection . Another percent experienced relatively minor complications. Almost percent had to have the bands entirely removed while percent needed to undergo subsequent surgery. The procedure appears to result in relatively poor longterm outcomes the researchers concluded. One in six of the patients ended up deciding to have a gastric bypass procedure and all of these patients demonstrated good outcomes following their subsequent surgery. Himpens said that patients should limit their expectations with respect to banding noting that all weightloss operations have a high failure rate. But he added that it is still defendable for surgeons to continue doing this. The high failure rate of the band gastroplasty in the long term is not that much worse than other procedures he noted. I therefore think patients will continue to ask for the procedure. But he cautioned that patients undergoing band surgery should do so knowing that they need to commit themselves to rigorous longterm followup. Meanwhile in a critique published alongside Himpens work Dr. Clifford W. Deveney a professor of surgery in the department of surgery at Oregon Health and Science University in Portland concluded that the current study does not shed a favorable light on the use of LAGB. The band has a spotty history Deveney said. Some groups have very good results with to percent weight loss. But other groups have either poor weight loss or complications or both. So I think he continued that the patient should be made aware of these facts and also that the weight loss is going to be less with the band than with a gastric bypass. And that itll take longer to achieve the weight loss because with gastric bypass most of the weight loss occurs over the first year while with a band it takes five to six years. Its also easier to cheat on the band he added. You can eat around the band and render it ineffective if youre not disciplined in following a healthy diet. With gastric bypass thats not as much of an issue. But all this is not to say that I think we shouldnt be doing bands. Its just not as good as bypass. Dr. Mitchell S. Roslin chief of bariatric surgery at Northern Westchester Hospital in Mount Kisco N.Y. said he was not surprised by the findings. I always tell my patients that bands are like going a diet with a seatbelt he said. And that theres bound to be a percent extraction rate of these bands per year that theyre in. Which actually comes to about the same percent of band removals these researchers observed among their patients. I think the problem with the bands is simply that having a fixed obstruction underneath your esophagus is not a natural occurrence Roslin noted. And also these bands make it more difficult to eat but they do not make every patient less hungry. So theres a big variability in treatment effect. Youll see patients who do great and patients who dont. Almost like a camel with two humps. So bands are easy to sell and very heavily marketed he added. But for many patients there are better options. More information For more on gastric banding visit the National Institutes of Health http SOURCES Jacques Himpens M.D. European School of Laparoscopic Surgery Saint Pierre University Hospital Brussels Belgium Clifford W. Deveney M.D. professor surgery department of surgery Oregon Health and Science University Portland Mitchell S. Roslin M.D. chief bariatric surgery Northern Westchester Hospital Mount Kisco N.Y. March Archives of Surgery online"

"A new study from the University of Illinois confirms a link between routine Pap smear screenings and a lower risk of de veloping cervical cancer in women over age . However most American health guidelin es discourage women in that age range from receiving screenings unless they have pr eexisting risk factors. The new findings are published in the journal Gynecologic Oncology . Some studies report that Pap smears are unnecessar y in older age while others show that there is a benefit in the over age group said Karin Rosenblatt a cancer epidemiologist and a professor of kinesiology and c ommunity health at Illinois. Theres been a great debate about it. Early research on cervical cancer screenings recomm ended not testing women over age . This suggested age cutoff for screening was increased in recent years as the disease and risk factors are better understood. While the incidence of cervical cancer is greater in adult women under the age of years those over tend to have more fatal cases of the disease Rosenblatt said. When detected early often via a Pap test prema lignant cervical cancer tissue can be removed or treated so it does not progress into mal ignant cancer. If you have regular Pap smears there is a greater chance the doctor will catch it before it progresses to malignant cervical cancer Rosenb latt said. She assessed whether regular Pap tests reduce the r isk of cervical cancer specifically in women over age . Rosenblatt and her team looked at Medicare billing data from and extracted information for more than women who had been recently diagnosed with cervical cancer as well as a group of more than pati ents who had no cancer diagnosis. The researchers determined which of the patients ha d received a screening Pap smear two to seven years prior to diagnosis. We found that the newly diagnosed cervical cancer group was less likely to have had a Pap smear compared with the control group Rosenb latt said. These results imply that routine Pap tests are bene ficial for preventing malignant cervical cancer in women over she said. Rosenblatt said there needs to be a more thorough c ostbenefit analysis of conducting the screenings in elderly women. While there is a c lear benefit of diagnosing cervical cancer for some groups such as those with short li fe expectancy or comorbid illnesses screenings may be unnecessarily invasive. There needs to be further study of the benefits an d risks of doing Pap smears in the elderly Rosenblatt said. Future studies should co mprehensively assess cervical cancer screenings in older women and more accurately infor m health policy recommendations."

"A new review httparchinte.jamanetwork.comarticle.aspxarticleid of the little pink pill for women with low sexual desire says the drug doesnt work very well but some doctors and patients whove been using the treatment disagree. The drug Addyi or flibanserin http has been on the market since October. The data presented in this review suggests that the meaningful change caused by flibanserin is minimal according to the team of Dutch researchers. The researchers looked at eight studies on Addyi that together included nearly women. They said for women using the drug the number of additional satisfying sexual events averaged out to about . per month. The agency asked Sprout Pharmaceuticals which makes Addyi to do more studies on the interaction between Addyi and alcohol. An editorial httparchinte.jamanetwork.comarticle.aspxarticleidaccompanying the article published in JAMA Internal Medicine questioned the FDAs approval of the drug. The FDA approved a marginally effective drug for a nonlifethreatening condition in the face of substantial and unnecessary uncertainty about its dangers wrote Dr. Steven Woloshin and Dr. Lisa Schwartz at the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice. The researchers said the drug had significant known side effects such as dizziness sleepiness and nausea. The FDA approved Addyi http last August with a black box warning to highlight the risks of severe low blood pressure and fainting when patients drink alcohol take certain drugs or have liver problems. I was amazed Some doctors and patients whove been using Addyi say the drug has been helpful. There are no other FDAapproved treatments for women suffering from low sexual desire. Female Viagra could be the biggest libido booster since...Viagra http Dr. Lauren Streicher medical director of the Center for Sexual Medicine at Northwestern Memorial Hospital in Chicago said the results cited in the Dutch study are averages and while Addyi doesnt work for everyone many of her patients have benefited from it. She says shes written Addyi prescriptions for about women and three or four have emailed her back to say its worked. They say Oh my God this has changed my life. Things are wonderful Streicher said. Jodi Cole a yearold stayathome mother from Porter Oklahoma said before she started taking Addyi she didnt want to have sex with her husband Matt. I love my husband and I believe God created emotional and sexual intimacy as key components of marriage. So we had sex usually a couple of times a week. And while I was willing part of me dreaded it. Every time Cole wrote in an email to CNN. Cole said she started taking Addyi in November and within six weeks felt a difference. I was amazed she wrote. I actually enjoyed being intimate and for the first time in a long time felt that connection with Matt. She said for her it wasnt about increasing the quantity of sex she was having but rather the quality. What Addyi does is give just enough support so I can think about that part of our relationship with anticipation of pleasure rather than anxiety she wrote. She understands Addyi can have side effects but said women should be able to choose to take it just as men choose to take Viagra despite its side effects. I should be able to choose whether the side effects are worth the benefit she wrote. The controversy over Addyi Seldom has one pill raised such controversy among medical professionals. Doctors who treat women with low libidos tore apart the JAMA study. Streicher an associate professor of clinical obstetrics and gynecology at the Northwestern University Feinberg School of Medicine said the study drew erroneous conclusions. myths about female Viagra busted http The International Society for the Study of Womens Sexual Health went even further calling the study a great disservice to the millions of premenopausal women suffering from hypoactive sexual desire disorder. The doctors had several problems with the studys methodology including that three of the eight studies the Dutch researchers analyzed were not published. When studies are published they go through a peer review process to assess whether the study methodology is sound. One of those studies used a dosage of the drug that was half as high as what the FDA approved. Dr. Loes Jasper one of the authors of the Dutch analysis said she and her colleagues removed the results from that study and still found that Addyis affects were minimal. She said she and her colleagues included the results of the unpublished studies because sometimes negative studies of a drug dont get published. Join the conversation See the latest news and share your comments with CNN Health on Facebook https and Twitter httpstwitter.comcnnhealth. We included all published and unpublished studies to capture a complete overview of the benefits and risks of flibanserin without bias Jaspers wrote in an email to CNN. According to the FDA which looked at three clinical trials of Addyi that included about women about more patients treated with Addyi reported meaningful improvements in satisfying sexual events sexual desire or reduced distress compared to women taking a placebo. In their editorial Woloshine and Schwartz said Sprout and others put pressure on FDA to approve the drug. While it is unclear how strongly politics influenced the decision it is clear that the science was weak they wrote. We all need a drug approval process that delivers good decisions based on adequate evidence."

"A new surgical tool that uses light to make sure surgeons removing cancerous tumors got it all was found to correlate well with traditional pathologists diagnoses in a clinical study showing that the tool could soon enable reliable realtime guidance for surgeons. The interdisciplinary research team led by Stephen Boppart a University of Illinois professor of electrical and computer engineering and of bioengineering performed the study on patients with breast cancers at the Carle Foundation Hospital in Urbana Illinois. The results appear in the journal Cancer Research. One difficult but crucial determination for surgeons and tissue pathologists is figuring out where a tumor ends. A solid tumor may be easily identifiable but the tissue around the main body of the tumor known as the margin may contain cancerous cells as well. Because of this excess tissue surrounding the tumor is typically removed but the question lingers of whether any cancer cells remain to reemerge later as tumors. In almost all solidtumor surgeries theres a question of margins said Dr. Boppart who also is a medical doctor. Typically surgeons will remove the tissue mass that contains the tumor and will send it to the lab. The pathologist will process section and stain the tissue then examine the thin sections on microscope slides. They look at the structure of the cells and other features of the tissue. The diagnosis is made based on subjective interpretation and often other pathologists are consulted. This is what we call the gold standard for diagnosis. The new device is a handheld probe based on a technology called optical coherence tomography OCT that uses light to image tissue in real time. Cancer cells and normal tissue scatter light differently because they have different microstructural and molecular features Boppart said so OCT gives physicians a way to quantitatively measure the cellular feature of a tumor. Surgeons can pass the OCT wand over a section of tissue and see a video on a screen with no special chemical stains or lengthy tissue processing required. In many cases you cant tell the difference between cancer cells and normal tissue with the naked eye but with OCT theyre very different said Boppart who also is affiliated with the Beckman Institute for Advanced Science and Technology at the U. of I. In the clinical study surgeons treated patients according to the standard surgical procedure but OCT data were collected from the margin of the tumor cavity and the margin of the removed tissue mass during surgery so that the results could be compared later. The study found that the OCT device analysis identified the differences between normal and cancerous tissue with percent sensitivity and percent specificity. They also found that the way that OCT spotted cancer in the removed tissue was closely correlated with the results from the postoperative pathology reports which often came days later. For the first time this study demonstrates the use of OCT for imaging tumor margins within the tumor cavity in the patient during surgery Boppart said. It is likely better to check to see if any residual tumor cells might be left behind rather than checking the tissue mass that was taken out. Then the surgeon can intervene immediately. The researchers will continue clinical studies with the OCT device looking at other types of solidstate tumors. Diagnostic Photonics a startup company Boppart cofounded that also collaborated on the study is commercializing the OCT probe technology for broader use. Ultimately new technological innovations like this in medicine and surgery are going to improve our health care and save lives. Thats when this work will be most rewarding Boppart said. The National Institutes of Health supported this work. Editors notes Editors note To reach Stephen Boppart call email boppartillinois.edu mailtoboppartillinois.edu. The paper Realtime imaging of the resection bed using a handheld probe to reduce incidence of microscopic positive margins in cancer surgery is available online at httpcancerres.aacrjournals.orgcontent.full."

"New research found two weeks of treatment with an antibiotic relieves symptoms for some sufferers of irritable bowel syndrome a poorly understood and painful condition that especially afflicts younger women. In two large studies percent of the patients who took the antibiotic rifaximin said their symptoms substantially improved compared to percent of those who got fake pills. Their relief lasted for up to weeks. Experts want to see if that translates into a longer term benefit. But the fact that relief extended beyond the two weeks of treatment suggests that weve actually touched on the cause of IBS as opposed to just covering up symptoms said Dr. Mark Pimentel of CedarsSinai Medical Center in Los Angeles who led the research in the U.S. and Canada. Irritable bowel syndrome or IBS is a common gastrointestinal ailment affecting as many as in Americans. It is more common in women than men. Main symptoms are abdominal pain bloating and diarrhea or constipation or both. What causes the disorder has been a mystery sensitivity to certain foods or stress are among the theories. Patients are typically told to change their diet reduce stress and take medicines or fiber supplements to ease symptoms. Some scientists think an overgrowth of bacteria in the gut is behind the problem but studies testing that have had mixed results. Pimentel and his colleagues tested rifaximin riFAXimen. Unlike other antibiotics this one is not absorbed very well so it stays in the gut and is less likely to develop resistance. Its also been safely used elsewhere for more than two decades. In the U.S. rifaximin is approved for travelers diarrhea and for a complication of liver disease. Salix Pharmaceuticals which markets rifaximin under the name Xifaxan in the U.S. is seeking to expand its use to IBS. A decision from the Food and Drug Administration is expected in March said William Forbes executive vice president and chief development officer for Salix. The price for IBS treatment hasnt been determined he said. But the price listed at Drugstore.com suggests its not cheap with a twoweek supply of the dosage used in the study costing or about a pill. The two studies reported in Thursdays New England Journal of Medicine involved patients who had mild to moderate irritable bowel syndrome without constipation the most common form. Participants were assigned to take milligrams of rifaximin or dummy pills for two weeks three times a day. For the next four weeks they were asked if their symptoms improved. Overall percent of those on rifaximin reported adequate relief for at least two weeks compared to percent on dummy pills. The benefits lasted for the weeks they were followed. While the response to rifaximin may seem low to outsiders its in the range seen with other effective IBS treatments said Dr. Jan Tack of the University of Leuven in Belgium. Other findings suggest that a larger number of patients may have had some benefit just not to the level of adequate relief that was used in these studies to measure response he said. In this condition where treatment options are really limited anything that works is always welcomed said Tack who wrote an accompanying editorial. Rifaximin does not treat all patients but the results are definitely novel and important. Still until more research is done he said the antibiotic should be restricted to those with confirmed bacterial overgrowth or patients who havent responded to other IBS treatments. The studies were paid for by the Salix based in Raleigh N.C. Some of the researchers were Salix employees and others had received consulting and other fees from the company. CedarsSinai holds a patent on the use of rifaximin for irritable bowel syndrome. Rifaximin worked for Amy McMahon who developed the disorder about four years ago. She tried a variety of treatments changed her diet and saw a number of specialists before Pimentel prescribed the antibiotic about a year later. I felt remarkably better after one treatment said McMahon a parttime actor and residential property developer in Temecula Calif. A few months later she took it again. Since then I feel maybe not percent but to percent of normal which to me is thrilling said McMahon who was not part of a study. She said it was frustrating to have an illness disrupt her life. She turned down social invitations especially going out to eat because food triggered her symptoms and skipped a fly fishing trip. Now I live my life how I used to she said."

"Hundreds of people have caught hellish bacterial infections and turned to Eastern Europe for a centuryold viral therapy. With the world on the cusp of an antibiotics crisis should we all follow suit Rachel George was used to being sick. A genetic condition left her with intellectual disabilities and a weak immune system. By she had endured dozens of bacterial infections kidney ear sinus heart bone and more and taken hundreds of antibiotic pills. But when she entered the Harborview Hospital in Seattle for a foot operation her bodys defenses were pushed to a new limit. Hospitals are hotbeds for nasty and sometimes deadly infections. After her surgery Rachels lungs picked up two methicillinresistant Staphylococcus aureus MRSA and Pseudomonas aeruginosa. Both bugs are part of a growing category of bacterial infections that dont respond to traditional antibiotics. Rachel was supposed to be in the hospital for five days. She stayed nine weeks. She developed pneumonia and acute respiratory distress syndrome and was put on a ventilator with a tube down her throat. When her doctors finally released her they told her mother she had three years to live at most before the bugs won. Three years later in January Rachel was indeed close to death. She was spending half of every month in intensive care the other half at home an IV constantly dripping into her bloodstream. By then she had cycled through more than a dozen powerful antibiotics. Each time the doctors would give her a new drug then watch helplessly as the bacteria overpowered it. Every time we took her back to the hospital it was a question of whether or not this was going to be it her mother Rose George told BuzzFeed News. One day the nurse on duty asked Rose if shed ever considered phage therapy. Rose had never heard of it and thats unsurprising The therapy which uses specialized viruses called bacteriophages to kill bacteria is only available in a handful of former Soviet countries. Rose asked her daughters doctor but shed never heard of phage either. Soon Rose was on the phone with doctors at a small clinic in Tbilisi in the Republic of Georgia ordering glass vials of viruses at a pop. Shes one of at least people desperate enough to try this littleknown viral therapy from Eastern Europe. Its an extreme solution to what may be this centurys biggest medical crisis the death of antibiotics. Since the discovery of penicillin in scientists have amassed a medical arsenal of more than antibiotics. The drugs have prevented soldiers from losing limbs and mothers from dying during childbirth. With access to antibiotics parents no longer worry about losing their kid to an ear infection or bad scrape. But now antibiotics are everywhere not just in orange pill bottles but in the food given to pigs cattle and chicken. And the more the bugs interact with antibiotics the quicker they evolve defense mechanisms. At least strains of bacteria have evolved into superbugs becoming resistant to most of our drugs. And pharmaceutical companies more interested in profitable blockbusters like Viagra and Zoloft havent developed a new class of antibiotics in years. Were dying because of it. More than people in the U.S. die each year from antibioticresistant infections. By an estimated million people worldwide will die by superbug. After two decades of warnings from the scientific community the problem is finally getting serious attention. In his budget proposal released today U.S. President Obama threw . billion at tackling the antibioticresistance crisis nearly double the amount allocated last year. If approved by Congress this money will go toward screening soil samples for new antibiotics reducing the drugs in livestock feed boosting hospital surveillance and perhaps making phage therapy a viable option in the U.S. Phages are bacterias natural enemies. They work by injecting their DNA inside bacterial cells where they replicate wildly produce new phages and eventually cause the bacteria to rupture releasing even more viruses to hunt for bacterial prey. Phages power comes from two places They are the most common and diverse organisms on Earth and each phage harms only specific strains of bacteria. When you turn on the faucet millions of phages flow out with your tap water. That leaves a nearly inexhaustible supply of potential agents to use in the fight against infection. Doctors have been using phages to kill bacteria for nearly a century just not in the U.S. In a Georgian doctor named George Eliava set up the first phage therapy clinic the Eliava Institute in Tbilisi. Antibiotics hadnt been discovered yet so phages were a revolutionary weapon against all kinds of infections Ryland Young head of the Center for Phage Technology at Texas AM University told BuzzFeed News. It was kind of prescientific no one knew what these phages were except that they worked. Five years later penicillin came along. Effective cheap and quick to produce in large quantities doctors in the U.S. U.K. and France quickly seized upon the miracle drug as a key to winning World War II. That also meant keeping this weapon away from the Soviets. With no access to antibiotics scientists behind the Iron Curtain bolstered their use of phages instead. At its very peak when they were supplying the Russian army the Eliava Institute was producing two to three tons of phages per day Zamphira Alavidze a microbiologist in Tbilisi who worked at the Eliava Institute for years told BuzzFeed News. But after the fall of the Soviet Union Eliavas phage production dropped significantly and it downsized into a small research center. Today Georgian doctors frequently use antibiotics to treat infections but often in combination with phages. Every clinic everywhere in Georgia everybody uses the phages Alavidze said. The last decade she added has brought another big change Two small phage clinics in Tbilisi have sprung up to cater specifically to the boom of international patients like Rachel. Ten or fifteen years ago nobody believed the phages would be so popular. They thought we were crazy Alavidze said. Now its not too easy to come to Georgia but we try to help somehow because sometimes nothing else works. Randy Wolcott a wound care doctor in Lubbock Texas first went to Tbilisi in . He was fed up with the lack of options for his patients with drugresistant infections and wanted to investigate phages as a treatment of last resort. Wolcott spent a week at the Eliava Institute. It looked nothing like the gleaming and sterile highrises of most U.S. hospitals the building was small some of the equipment looked ancient and the walls were unpainted. But after observing the Georgian clinicians at work Wolcott was sold. He walked into a city pharmacy and bought hundreds of vials of phages concocted for wound infections. They were very cheap and I bought them by the case Wolcott told BuzzFeed News. The only hiccup came when explaining his viral cargo to U.S. customs officials. It can cause some problems when our government hears that youre bringing viruses back from a former Soviet country Wolcott said chuckling. Its hard to explain. Its a virus but its a virus only for bacteria not for us. Phages arent approved for use in the U.S. So once back in Lubbock Wolcott wrote to the Texas Board of Medicine and asked for permission to use the viruses on his wound patients. The board decided that because these patients had exhausted all other options Wolcott would be allowed to use the experimental treatment in a legal arrangement known as compassionate use. Wolcotts patients saw improvement within days. In of the cases the patients wounds healed enough to save their limbs. He treated hundreds of patients using the original batch of phages he brought over from Tbilisi. Five years ago he went back for more. Wolcott usually uses the phages in combination with traditional antibiotics. But he says he couldnt have offered the same quality of treatment without the viruses. Someone needs to do this in America Wolcott said. To have a bank of stuff that we can turn to for these chronic infections That would be huge. Until that happens though patients are looking abroad. Rose Georges internet search led her to a clinic in Tbilisi called the Phage Therapy Center. It was set up in by Phage International a fledgling medical tourism outfit founded in Danville California by a computer scientist named Chris Smith. The centers doctors asked Rose to send over a bacterial sample from Rachels lungs. Over the course of a month Rose attempted to send several samples but each was rejected by U.S. customs. Roses son tried driving a sample across the border into Canada which led to a sevenhour interrogation by Canadian agents followed by two more hours with the FBI on the U.S. side. Finally Smith suggested that Rose ambiguously label the package as medical records. She did and the shipment slipped through. A few weeks later the Georgian doctors called Rose with good news They would be able to design a concoction of phages to treat Rachels infections. After convincing Rachels doctor to write a prescription for the viruses so they could cross the U.S. border Rose paid the Georgian clinic for a threemonth supply. She was surprised that phages were so inexpensive in contrast her insurance company was forking over roughly a month for Rachels antibiotics. A couple of weeks later boxes filled with vials of phages landed on the Georges doorstep. Rose used a nebulizer to administer the phages twice a day so that Rachel could breathe the liquids into her lungs. Within three weeks Rachels MRSA the same infection shed been fighting with antibiotics for three years disappeared. It hasnt returned in the five years since. Advocates of phage therapy see it as a powerful new weapon in the war were quickly losing against bacterial infection. But phages are certainly not a cureall. Just ask Roger Mintey a yearold retired accountant from the sleepy English town of Reigate. In Mintey caught a severe sinus infection that left him with a nearconstant cold. Hes had it on and off ever since. In the first decade of fighting his illness Mintey sought help at five English hospitals underwent two surgeries and took more than two dozen courses of antibiotics. Nothing worked. In he heard about phage therapy from his cousins wife whod gone to Tbilisi to treat a chronic bladder infection. She pointed Roger to Phage International the same company that helped Rose George get her daughters phages. The Georgian doctors affiliated with the company said they could treat his sinus infection so Mintey cut Phage International a check for and sent a sample of his nasal discharge to Georgia via FedEx. Then accompanied by a friend he boarded his firstever plane to fly to the companys Phage Therapy Center. They landed in Tbilisi at a.m. and were met by someone from the clinic who escorted them to their hotel. Mintey was instructed to drink a phage preparation three times a day from his hotel room. Every couple of days he would go into the clinic for additional phage treatments. The clinic was inside a nondescript building set up something like an indoor mall. You went through a set of double doors passed by a suntanning place and there you were one office two treatment rooms and that was it Mintey told BuzzFeed News. A doctor and two nurses had him sit on a cushioned patients chair. They tipped the chair back so his nostrils faced up and poured the phage liquid into his nose. He was instructed to say the word cuckoo as the phages slowly slid into all of his sinuses seeping out from his nasal passages into his forehead and cheekbones. His nose started bleeding but the clinicians told him it was nothing to worry about. They also gave him a shot of manuka honey extract in his butt telling him it had antimicrobial properties. It was all quite uncomfortable Mintey said. After two weeks Mintey flew back to England. Three days later his infection was back. I realized the entire treatment had done absolutely nothing he said. Mintey claims to have called emailed faxed and sent physical letters to his doctors in Georgia and to Phage Internationals headquarters in California. He heard nothing back. Smith of Phage International claims that emails sent to Roger at the time were bouncing and that he only had Minteys friends phone number. Eventually the clinic sent Mintey more phages in the mail but the infection persisted. He says he has not heard from them since. I was very disappointed Mintey said. By the end of I had given up on phages. Minteys situation highlights many of the difficulties surrounding a therapy only accessible through a small and largely unregulated medical tourism industry. Smith says Phage International has served more than patients to date with some registered on its website. He wants to open a new phage therapy clinic in Trinidad which could be easier for American patients to visit. During the past years youd go to an investor or venture capitalist and theyd never heard of phage and they didnt want to know about it he said. Now thats changed. Nothing about Phage International is decidedly illegal I. Glenn Cohen a law professor at Harvards PetrieFlom Center for Health Law Policy Biotechnology and Bioethics told BuzzFeed News. But there are many ethical issues at play. What happens when something goes wrong Or as in Rogers case when a patient feels like hes not getting what he paid for Who do you go after Where do you do it Cohen said. Thats where things get more tricky. This year two clinical trials are testing phage treatment against several antibioticresistant infections. The first called Phagoburn is big testing burn victims at three European hospitals with a . million investment from the European Union. The second led by a Richmond Virginiabased biotech called AmpliPhi is smaller and privately funded but will include a collaboration with the U.S. Army which has a vested interest in treating wounded soldiers. Both studies will be an important first step in giving phage therapy the credibility it will need to pass muster with the Food and Drug Administration FDA and to gain the support of drug companies needed to fund its eventual commercial development. Big pharmaceutical companies like stuff to appear in bottles and in tablets Jeremy Curnock Cook AmpliPhis CEO told BuzzFeed News. Theyre waiting for people like us to come back with the clinical data. But the biggest obstacle for phage therapy in the U.S. may ultimately have less to do with the science than its implementation into the medical system. Rachel George and Roger Mintey both received personalized phage treatments meaning that the viruses were selected to specifically attack their particular infections. Its uncertain whether the FDA would be able to adopt such a tailormade approach which stands in such stark contrast to the onesizefitsmost approach of antibiotics. Whats more because of the number and diversity of phages and a regulatory system thats been set up to deal with manufactured chemicals rather than the messiness of nature each phage would have to be tested as its own drug even if its used in combination. In a concoction of nine phages designed to treat a mixture of three bacteria that could mean hundreds of trials. Depending on who you ask this is viewed as anything from costly to impossible. Regardless of whether phage therapy reaches widescale use one thing is clear Sticking to the status quo is not an option. With million Americans a year acquiring bacterial infections that are no longer thwarted by antibiotics the era of blissful overdependence on these onetime miracle drugs is drawing to a close. Im quite optimistic about the future of phage says Randy Kincaid senior scientific officer for the arm of the National Institutes of Health that will be overseeing phage therapy development. But I think until and unless people take the more structured approach to understanding and using and developing the treatment well always be asking what if What if wed only done it better what if wed only done it the right way. For Rose George the knotty issues surrounding phage therapy are all beside the point. The Phage Therapy Center gave her access to a treatment she couldnt get in her own country. And that treatment is still ongoing. Though phages cleared one of Rachels infections beautifully the other the Pseudomonas is a stubborn bug. Every three months the Phage Therapy Center asks Rose to send a new sample from Rachels lungs and when the bacteria mutates they send a new mixture of phages. Somehow the infection persists. But Rose is grateful that Rachels infections are finally under control. While the hospital is still their second home because of Rachels numerous other health issues she recently had hip replacement surgery and had her gallbladder removed the infections are no longer what are bringing here there. These people saved my daughters life Rose said. It is crazy that its not part of our arsenal."

"Days after bringing home her newborn twin daughters Alysia Vaccaro could sense Evangelina wasnt as healthy as her sister. I had a baby to compare her to and I just knew something was wrong with her Vaccaro told CBS News. Her mothers intuition was right. Testing revealed Evangelina was born with Severe Combined Immunodeficiency also called SCID or bubble baby https disease. Its a genetic disorder that leaves the body with a weakened immune https system making infants extremely vulnerable to illness. It affects cells that play important roles in helping the immune system battle bacteria viruses and fungi that can cause infections. Even the common cold can be deadly. Symptoms of the disease are frequently first noticed very early in life as was the case with Evangelina. Babies with SCID often come down with recurrent severe respiratory infections that can be life threatening according to the American Academy of Allergy Asthma and Immunology. We wore masks we had hand sanitizer we had raw hands from cleaning so much Vaccaro recalled. The Vaccaros turned to Dr. Donald Kohn at the Broad Stem Cell Research Center at UCLA where Kohn focuses on the development of new methods to treat genetic diseases of blood cells. They enrolled baby Evangelina in a clinical trial there. Dr. Kohn said of an experimental treatment for SCID https Its gone from a one day maybe to a real clinical reality. That means an actual cure for the disease said Kohn who is also director of the Human Gene Medicine Program at UCLA. His treatment involves taking bone marrow from the patient to gather stem cells. A cloned gene is then added to correct what was missing at birth. Those stem cells are given back to the patient where they can go back to the bone marrow and make the blood cells for the rest of the patients life Kohn said. So far the treatment has restored immune systems in all patients in the most recent clinical trials including Evangelina. It is a cure. I know its a cure. Were living the cure said Vaccaro. Now years old doctors say Evangelina is in perfect health. Dr. Kohn is currently working with the FDA to make his treatment available nationwide. Hes also testing the same method as a cure for sickle cell disease. Clinical trials for that treatment are now underway."

"Scientists have raised the possibility of using statins drugs used for reducing cholesterol to stop some breast cancer tumours returning. The most common form of breast cancer uses oestrogen to grow. Drugs such as tamoxifen and aromatase inhibitors cut off the supply of oestrogen reducing the chances that the cancer will return after surgery. But about of the diagnosed oestrogenreceptor positive ERpositive cancers still recur every year. Early research most of it still in the lab published in the journal Breast Cancer https Research has shown that some early breast cancer tumours can produce a molecule made from cholesterol called hydroxycholesterol HC. It can mimic oestrogen and encourage tumours to grow. Dr LesleyAnn Martin http at the Institute of Cancer Research in London where the research has been carried out said During the course of treatment ERpositive breast cancers that are fed by oestrogen often become resistant to standard hormone therapy. Our research has demonstrated that these cancer cells can use a cholesterol molecule to mimic oestrogen so that they continue to grow without it. This is hugely significant. Testing the patients tumour for HC or the enzymes that make it may allow us to predict which patients are likely to develop resistance hormone therapy and tailor their treatment accordingly. Our study also demonstrates that statins could be a valuable addition to breast cancer treatment and that this warrants investigation in clinical trials. The research has not yet been tested in humans. The scientists grew cancer cells in the lab in the absence of oestrogen and found they produced an alternative fuel in the form of the cholesterol molecule. They then interfered with production of the molecule and found it slowed the cancer cells growth by between and . The scientists say the findings are boosted by two studies which found the overactivation of certain genes linked to cholesterol production were linked with a poorer response to the anticancer drugs. Cholesterol production by the tumour will not be the only reason why ERpositive breast cancers recur but campaigners are excited by the possibilities for a treatment if further research corroborates these findings. Delyth Morgan chief executive at Breast Cancer Now httpbreastcancernow.org which funded the research said This is a really crucial discovery. Far too many women have to deal with the potentially devastating consequences of their breast cancer coming back and this research presents an important opportunity to improve the effectiveness of todays most commonly used treatments. This study breaks new ground in uncovering how some breast cancers continue to survive without oestrogen and suggests that women could benefit from adding statins to standard antihormone treatments. But this is early research and greater clinical evidence is now needed to understand the potential risks and benefits of this approach. Another charity Breast Cancer Care https said the research was promising but needed further trials. This early study raises an interesting question of whether cholesterolreducing treatment such as statins could help lower the chances of breast cancer returning for some women who have developed a resistance to hormone therapy said Jane Murphy clinical nurse specialist. We know that many women can be consumed with fear of their breast cancer coming back which can have a huge impact on their ability to move forward after treatment. This discovery may in future help reduce these concerns for some patients by allowing doctors to test if their cancer is likely to return and tailor treatment accordingly."

"In a report on what is believed to be the first small clinical trial of its kind researchers at the Johns Hopkins Kimmel Cancer Center say they have safely used immune cells grown from patients own bone marrow to treat multiple myeloma a cancer of white blood cells. Results of the trial involving a particular type of tumortargeting T cell known as marrowinfiltrating lymphocytes MILs are described in the May issue of Science Translational Medicine. What we learned in this small trial is that large numbers of activated MILs can selectively target and kill myeloma cells says Johns Hopkins immunologist Ivan Borrello M.D. who led the clinical trial. MILs he explains are the foot soldiers of the immune system and attack foreign cells such as bacteria or viruses. But in their normal state they are inactive and too few in number to have a measurable effect on cancer. Previous laboratory research by Borrello and his colleagues showed that activated MILs could selectively target and kill myeloma cells taken from patients and grown in laboratory culture flasks. For the clinical trial the Johns Hopkins team enrolled patients with newly diagnosed or relapsed multiple myeloma although three of the patients relapsed before they could receive the MILs therapy. The scientists retrieved MILs from each patients bone marrow grew them in the laboratory to expand their numbers activated them with microscopic beads coated with immune activating antibodies and intravenously injected each of the patients with their own cells. Three days before the injections of expanded MILs patients received high doses of chemotherapy and a stem cell transplant standard treatments for multiple myeloma. One year after receiving the MILs therapy of the patients had at least a partial response to the therapy meaning that their cancers had shrunk by at least percent. Seven patients experienced at least a percent reduction in tumor cell volume and lived on average . months without cancer progression. The remaining patients had an average of . progressionfree months following MILs therapy. None of the participants had serious side effects from the MILs therapy. The overall survival was . months for those with less than percent disease reduction but this number has not yet been reached in those with better responses. The average followup time is currently more than six years. Borrello notes that several U.S. cancer centers have conducted similar experimental treatments known as adoptive T cell therapy but says the Johns Hopkins team is believed to be the only one to use MILs. Other types of tumorinfiltrating cells can be used but they are usually less plentiful in patients tumors and may not grow as well outside the body says Borrello. In nonbloodbased tumors such as melanoma only about onehalf of patients have T cells in their tumors that can be harvested and only about onehalf of those harvested cells can be grown. Typically immune cells from solid tumors called tumorinfiltrating lymphocytes can be harvested and grown in only about percent of patients who could potentially be eligible for the therapy. But in our clinical trial we were able to harvest and grow MILs from all patients says Kimberly Noonan Ph.D. a research associate at the Johns Hopkins University School of Medicine. Noonan says the small trial helped her and her colleagues learn more about which patients may benefit from MILs therapy. For example they were able to determine how many of the MILs grown in the lab were specifically targeted to the patients tumor and whether they continued to target the tumor after being infused. Additionally the scientists found that patients whose bone marrow before treatment contained a high number of certain immune cells known as central memory cells also had better response to MILs therapy. Patients who began treatment with signs of an overactive immune response did not respond as well. Noonan says the research team has used these data to guide two other ongoing MILs clinical trials. Those studies she says are trying to extend antitumor response and tumor specificity by combining the MILs transplant with a Johns Hopkinsdeveloped cancer vaccine called GVAX and the myeloma drug lenalidomide which stimulates T cell responses. The researchers say the trials also have shed light on new ways to grow the MILs. In most of these trials you see that the more cells you get the better response you get in patients. Learning how to improve cell growth may therefore improve the therapy says Noonan. Kimmel Cancer Center scientists are also developing MILs to treat solid tumors such as lung esophageal and gastric cancers as well as the pediatric cancers neuroblastoma and Ewings sarcoma. Experts report there are more than new cases of multiple myeloma and more than deaths each year in United States. It is the second most common cancer originating in the blood. Other Johns Hopkins scientists who contributed to the research include Carol Ann Huff Janice Davis M. Victor Lemas Susan Fiorino Jeffrey Bitzan Anna Ferguson Amy Emerling Leo Luznik William Matsui Jonathan Powell Ephraim Fuchs Gary L. Rosner C. Epstein Lakshmi Rudraraju Richard F. Ambinder Richard J. Jones and Drew Pardoll. Funding for the study was provided by the Commonwealth Fund P CA P CA and the Baca and Morisi Funds. Media Contacts Vanessa Wasta wastajhmi.edu mailtowastajhmi.edu Amy Mone amonejhmi.edu mailtoamonejhmi.edu"

"A patients own heart cells can be used to regrow new heart tissue and help undo damage caused by a heart attack according to early research published on Monday. Scientists at CedarsSinai Medical Center in Los Angeles and Johns Hopkins University in Baltimore were able to treat heart attack patients with cells grown from their own heart tissue. Not only did this show that the procedure was safe it also showed that the cells can help reduce scarring and even cause new heart muscle to grow. When a person suffers a heart attack he or she is often left with huge areas of scarring in the heart. Scarred heart muscle doesnt pump blood as well as it used to putting stress on other parts of the heart to make up for the deficit. The damaged area also doesnt conduct electric current as well leading to an abnormal heart rhythm which can cause more problems. Heart attack patients often go on to develop heart failure. This is the first instance of therapeutic regeneration says Dr. Eduardo Marbn director of the CedarsSinai Heart Institute. He says while nature abounds with examples of spontaneous regeneration of limbs or tissues like a salamanders new tail or a human liver regrowing to full size if partially damaged doctors have not been able to help patients regrow heart tissue. This could change in the future if larger clinical trials and longer patient outcomes confirm the results of this early research published Monday in the journal The Lancet http Marbn and his colleagues first presented this research at an American Heart Association http conference in November. To qualify for this clinical trial patients had to have suffered a recent heart attack and had to have a significant amount of damage to begin with and werent squeezing blood into the body as well as they should have says Dr. Peter Johnston one of the study authors who injected the new heart cells into patients treated at Johns Hopkins Hospital. A total of patients participated in the clinical trial which was designed to determine if it was safe to have cells grown from ones own heart tissue injected back into the heart. Seventeen patients received the stem cell transplants while the other eight patients were given conventional postheart attack therapy. In an outpatient procedure under local anesthesia doctors funneled a catheter into the patients heart and removed peppercornsized bits of tissue from the part of the patients heart that was unaffected by the heart attack. Using a procedure invented by Marbn heart stem cells were isolated from the tissue and then millions of new cells were grown in a petri dish. About four to six weeks after having suffered the heart attack the patients had either million or million heartderived cells injected back into the their hearts. Marbn says when the first patient data came in he and his colleagues were relieved to see the procedure was safe. After months researchers report only one patient appeared to have a serious side effect that may have been connected to the experimental cells. Six months after the first patient was injected with his cells grown from his own heart tissue Marbn says there was dramatic shrinking of scar tissue and new tissue had grown. That was unprecedented he says. No one had demonstrated that before. All patients were followed for six months and researchers have month data for patients. In patients who received the cell transplant Marbn says about half of their scar tissue dissolved and the reduction in scar size appears to get bigger after the first six months. He says that why this is happening is still unclear. Marbn says the amount of new heart tissue that grew was not subtle. On average grams about . ounces of new heart tissue grew which he says is quite remarkable considering this had never been done before and the average weight of the part of the heart that is responsible for pumping the blood through the body is about grams about . ounces. Patients in the control group those who didnt get a cell transplant did not regenerate any tissue and the amount of scar tissue they had remained the same. Sonia Skarlatos Ph.D and deputy director of the Division of Cardiovascular Sciences at the NIHs National Heart Lung and Blood Institute says this early research is very exciting and a move in the right direction. She cautions that this procedure has to be tested on many more patients and they have to be observed for longer periods than in the current study but she says these results are all very positive. She is hopeful further studies will confirm these early results. By preventing the consequences of a heart attack you may be able to prevent further down the heart failure that happens in many of these patients. Skarlatos says. She was not involved in the research but the National Heart Lung and Blood Institute did help fund it. Skarlatos also says its still not clear exactly what is making the heart regenerate and scar tissue disappear. Is it the cells themselves or proteins and other factors produced by these newly introduced cells that help fix the heart Further research will hopefully also help answer those questions she says. The study authors say based on these results further research is warranted. Marbn who began his research at Johns Hopkins says we did see a glimmer of regeneration in animal testing but the results in humans were much better. That doesnt usually happen this way in research."

"Newer blood pressure drugs are as safe and effective as older medications new research suggests. Scientists at the NYU Langone Medical Center in New York City said their findings settle a longstanding debate about which of two types bloodpressure lowering medications studied are better. An analysis of randomized trials involving more than patients examined the effects of newer angiotensin receptor blockers ARBs and older angiotensinconverting enzyme ACE inhibitors. Although ACE inhibitors were developed years earlier both types of drugs showed similar effects in the analysis challenging previous findings that suggest ACE inhibitors have greater benefits. According to the new analysis published online Jan. in the Mayo Clinic Proceedings the only difference between the medications is that ARBs are more easily tolerated. There has been debate for many years over the safety and efficacy of ACE inhibitors compared to ARBs with many of them using an ACE inhibitorfirst approach with ARBs regarded as less effective study author Dr. Sripal Bangalore said in a medical center news release. We believe that our study ends the debate and gives physicians the option to prescribe either drug for their patients added Bangalore an associate professor in the division of cardiology in the department of medicine at NYU Langone. Both ARBs and ACE inhibitors interfere with the function of a hormone called angiotensin II which regulates blood pressure but they do this in different ways the study authors said. Angiotensin II restricts blood flow through vessels raising blood pressure. ACE inhibitors prevent the body from making angiotensin II while ARBs prevent the hormone from doing its job by taking its place on the surface of blood vessels the researchers explained. Previous studies have suggested that older ACE inhibitors are more effective than ARBs. But this latest analysis attributed that difference to changes in the standard of care over the decade between trials of the two types of drugs greater emphasis on quitting smoking and wider use of cholesterollowering drugs called statins. However when trials were conducted at similar times one drug was not more effective than the other the findings showed. This is the first time that we have a clear and consistent message from the three buckets of trials of ACE inhibitors and ARBs all of which show that there is no outcome difference between the two agents except for better tolerability of ARBs Bangalore said. The results of our analysis are especially important for patients given that many ARBs are now also generic which reduces their costs he added. More information For more about blood pressure drugs visit the American Heart Association http_UCM__Article.jsp. SOURCE NYU Langone Medical Center news release Jan."

"When patients present with neurologic symptoms such as severe headaches or seizures the symptoms could suggest anything from infection cancer or an autoimmune disease of the brain or spinal cord leaving physicians scrambling to find the cause in a short amount of time. The differences in diagnosis can mean having mere hours to act or being able to take days or weeks to devise a treatment plan. Now researchers at Jefferson https Philadelphia University Thomas Jefferson University have developed a test that could rapidly parse out infections of the brain from other diseases. The diagnostic could prove particularly useful in infants and young children. We have many tests for making diagnoses but the ones that conclusively indicate infection can often take more time than wed like especially in cases of childhood meningitis or encephalitis said Mark Curtis https MD PhD Associate Professor of Pathology Anatomy and Cell Biology who also works as a hospital pathologist. Once confirmed with additional research our test could provide a first rapid and less invasive way to look at whats happening in the brain and guide treatment or further testing. The results were published in the journal PLOS ONE httpsjournals.plos.orgplosonearticleid.journal.pone. on October st. Rather than testing for the presence of bacteria or virus the researchers looked at the first telltale signs of infection the cytokines produced by the patients immune system in response to pathogens and other injury processes. Cytokines are an alarm system in the body said Dr. Curtis. Infectious agents activate a multipronged inflammatory response a key component of which is the release of different combinations of cytokines tailored to combat pathogens. Changes in cytokine levels of cerebrospinal fluid offer a very early measurable sign of infection. Dr. Curtis and colleagues decided to see if they could detect patterns within the cytokines that might differentiate infections from other brain diseases or disorders. In the retrospective analysis the investigators looked at samples collected from patients who had received spinal taps during their hospital stays. The researchers then tested the cerebral spinal fluid CSF for the presence of different cytokines and noticed that patients with confirmed infection of the central nervous system had a different cytokine fingerprint from those confirmed as having tumors or autoimmune disease. This suggested the test could be used to tell the conditions apart. Additionally within the patients identified with central nervous system infections the CSF cytokine fingerprint was different in cases of viral infection compared to those with nonviral pathogens such as bacteria or fungi. With only a small amount of spinal fluid needed CSF cytokine analysis could be used as one of the first diagnostic tests to rapidly triage serious central nervous system disorders and guide immediate intervention said first author Danielle Fortuna MD an Assistant Professor in the Department of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania. Worldwide meningitis and encephalitis affect more than four million adults and children each year. Infants and young children have an especially high risk of meningitis and encephalitis and the related often serious sequelae said Dr. Curtis. Being able to rapidly identify a central nervous system disorder as infectious can be crucial in rapid response. In addition the test could distinguish viral from nonviral infections a distinction that could spare a child with a viral infection from an unnecessary course of antibiotics and tailor the care toward antiviral and supportive measures as needed said Dr. Curtis. Moving forward our goal is to formally validate our findings with a larger sample size that includes both adults and children for future use in the clinical arena. Article reference Danielle Fortuna D Craig Hooper Amity L Roberts Larry A Harshyne Michelle Nagurney Mark T Curtis Potential role of CSF cytokine profiles in discriminating infectious from noninfectious CNS disorders PLOS ONE DOI .journal.pone. httpsjournals.plos.orgplosonearticleid.journal.pone. . Media Contact Edyta Zielinska edyta.zielinskajefferson.edu mailtoedyta.zielinskajefferson.edu ."

"Study evaluated efficacy and safety of XARELTO apixaban and dabigatran each versus warfarin Twoyear results show XARELTO was associated with reduced stroke and systemic embolism versus warfarin without altering risk of major bleeding The Janssen Pharmaceutical Companies of Johnson Johnson today announced new realworld data that showed frail patients with nonvalvular atrial fibrillation NVAF experienced significantly fewer strokes and systemic emboli when treated with XARELTO rivaroxaban over a twoyear period compared to those taking warfarin. Specifically longterm XARELTO use reduced the risk of stroke and systemic embolism by percent and ischemic stroke alone by percent compared to warfarin with no significant increase in major bleeding. Results from the study which also assessed the efficacy and safety of apixaban and dabigatran each versus warfarin were recently published in the Journal of the American Heart Association httpjaha.ahajournals.orgcontente. Click to Tweet httpsctt.aczta New twoyear realworld data show Janssen blood thinner significantly reduced stroke in frail NVAF patients JAHA RWE AFib httpsctt.aczta Affecting nearly six million Americans NVAF increases a persons risk of stroke by five times and accounts for to percent of all strokes.iii Frailty is a common clinical syndrome mainly seen in older adults that makes it harder for them to recover from stressful cardiovascular events and vulnerable for poorer health outcomes. People with NVAF are four times more likely to be classified as frail than people without NVAFiii and research has shown frail people with NVAF are less likely to receive anticoagulation than nonfrail people.ivvvi There is not widespread consensus on the best way to manage frail patients with NVAF in clinical practice which is why some patients are not treated at all and remain at high risk of having a stroke said Craig Coleman PharmD Professor of Pharmacy Practice University of Connecticut. These results show longterm rivaroxaban use reduced stroke and systemic embolism in a vulnerable patient group without increasing the risk of major bleeding. They also give physicians important insights into a welltolerated effective approach to treat their frail patients with NVAF. In the study researchers used U.S. Truven MarketScan claims data and identified frail patients with NVAF taking XARELTO apixaban or dabigatran. Each treatment group was matched separately with warfarin users in a ratio and followed for up to two years or until an event insurance disenrollment or end of followup occurred. The primary efficacy outcome was stroke ischemic or hemorrhagic or systemic embolism. Major bleeding was the primary safety outcome. Researchers made the following twoyear observations XARELTO was associated with a percent reduction in stroke or systemic embolism HR. CI.. and percent reduction in ischemic stroke alone HR. CI.. compared to warfarin. XARELTO had similar rates of major bleeding compared to warfarin HR. CI... Though both apixaban and dabigatran treatment were associated with numerically fewer strokes neither statistically significantly reduced the risk of stroke or systemic embolism at two years compared to warfarin HR. CI.. and HR. CI... Rates of major bleeding were also evaluated for apixaban versus warfarin HR. CI.. and dabigatran versus warfarin HR. CI... This study adds to the growing body of evidence supporting the positive efficacy and safety profile of XARELTO across a broad spectrum of patients with NVAF which now includes the frail population said Paul Burton MD PhD FACC Vice President Medical Affairs Janssen Pharmaceuticals Inc. Realworld data like this study are critical to informing and helping physicians best treat their patients cardiovascular diseases. About the Frailty Study A total of patients were identified using claims data from U.S. MarketScan databases from November to December . These patients were new users of anticoagulant therapy with XARELTO apixaban dabigatran or warfarin who had not been previously treated with an anticoagulant. They also had at least months of continuous insurance coverage and were considered frail. Frailty was determined using the Johns Hopkins Claimsbased Frailty Indicator scoring algorithm which weighs criteria identifiable in claims data including demographics comorbidities and physical and cognitive dysfunction. Each eligible XARELTO apixaban and dabigatran user was propensity score matched to a warfarin user in a ratio which helped minimize the presence of baseline differences between cohorts. A total of patients were included in the retrospective study with taking XARELTO apixaban dabigatran and warfarin. This study was supported by Bayer AG Berlin Germany. Realworld data have the potential to supplement randomized controlled trial data by providing additional information about how a medicine performs in routine medical practice however they have limitations and cannot be used as standalone evidence to validate the efficacy andor safety of a treatment. Additionally it is possible some of the analyses within this specific study may not have been sufficiently powered based on smaller sample sizes. About RealWorld XARELTO Research XARELTO is the moststudied oral Factor Xa inhibitor in the world today. More than people have been evaluated in published realworld research since the approval of XARELTO across all approved indications in the U.S. Postmarketing studies and registries continue to confirm the safety and efficacy of XARELTO in routine clinical use across a broad spectrum of patients. There have been no headtohead randomized trials directly comparing nonvitamin K antagonist oral anticoagulants. One recent study REVISITUS https found XARELTO is providing an appropriate balance of benefit and risk with respect to ischemic stroke and found a significant reduction in intracranial hemorrhage in routine clinical practice. These are two of the most serious types of events physicians work the hardest with their patients to avoid given their potential for irreversible harm. WHAT IS XARELTO XARELTO rivaroxaban is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke. XARELTO is also a prescription medicine used to treat deep vein thrombosis DVT and pulmonary embolism PE and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least months. XARELTO is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery. IMPORTANT SAFETY INFORMATION What is the most important information I should know about XARELTO rivaroxaban For people taking XARELTO for atrial fibrillation People with atrial fibrillation an irregular heart beat are at an increased risk of forming a blood clot in the heart which can travel to the brain causing a stroke or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. XARELTO can cause bleeding which can be serious and rarely may lead to death. This is because XARELTO is a blood thinner medicine anticoagulant that reduces blood clotting. While you take XARELTO you are likely to bruise more easily and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding including o Aspirin or aspirincontaining products o Nonsteroidal antiinflammatory drugs NSAIDs o Warfarin sodium Coumadin Jantoven o Any medicine that contains heparin o Clopidogrel Plavix o Selective serotonin reuptake inhibitors SSRIs or serotonin norepinephrine reuptake inhibitors SNRIs o Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding Unexpected bleeding or bleeding that lasts a long time such as o Nosebleeds that happen often o Unusual bleeding from gums o Menstrual bleeding that is heavier than normal or vaginal bleeding Bleeding that is severe or you cannot control Red pink or brown urine Bright red or black stools looks like tar Cough up blood or blood clots Vomit blood or your vomit looks like coffee grounds Headaches feeling dizzy or weak Pain swelling or new drainage at wound sites Spinal or epidural blood clots hematoma People who take a blood thinner medicine like XARELTO and have medicine injected into their spinal and epidural area or have a spinal puncture have a risk of forming a blood clot that can cause longterm or permanent loss of the ability to move paralysis. Your risk of developing a spinal or epidural blood clot is higher if o A thin tube called an epidural catheter is placed in your back to give you certain medicine o You take NSAIDs or a medicine to prevent blood from clotting o You have a history of difficult or repeated epidural or spinal punctures o You have a history of problems with your spine or have had surgery on your spine If you take XARELTO and receive spinal anesthesia or have a spinal puncture your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain tingling numbness muscle weakness especially in your legs and feet or loss of control of the bowels or bladder incontinence. XARELTO is not for people with artificial heart valves. Do not take XARELTO if you Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO. Before taking XARELTO tell your doctor about all your medical conditions including if you Have ever had bleeding problems Have liver or kidney problems Are pregnant or plan to become pregnant. It is not known if XARELTO will harm your unborn baby. o Tell your doctor right away if you become pregnant during treatment with XARELTO. Taking XARELTO while you are pregnant may increase the risk of bleeding in you or in your unborn baby. o If you take XARELTO during pregnancy tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See What is the most important information I should know about XARELTO for signs and symptoms of bleeding. Are breastfeeding or plan to breastfeed. XARELTO may pass into your breast milk. You and your doctor should decide if you will take XARELTO or breastfeed. Tell all of your doctors and dentists that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before you have any surgery medical or dental procedure. Tell your doctor about all the medicines you take including prescription and overthecounter medicines vitamins and herbal supplements. Some of your other medicines may affect the way XARELTO works. Certain medicines may increase your risk of bleeding. See What is the most important information I should know about XARELTO How should I take XARELTO Take XARELTO exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO unless your doctor tells you to. Your doctor may change your dose if needed. If you take XARELTO for o Atrial Fibrillation Take XARELTO time a day with your evening meal. If you miss a dose of XARELTO take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. o Blood clots in the veins of your legs or lungs Take XARELTO or times a day as prescribed by your doctor. For the mg and mg doses XARELTO should be taken with food. For the mg dose XARELTO may be taken with or without food. Take your XARELTO doses at the same time each day. If you miss a dose If you take the mg dose of XARELTO times a day a total of mg of XARELTO in day Take XARELTO as soon as you remember on the same day. You may take doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. If you take XARELTO time a day Take XARELTO as soon as you remember on the same day. Take your next dose at your regularly scheduled time. o Hip or knee replacement surgery Take XARELTO time a day with or without food. If you miss a dose of XARELTO take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. If you have difficulty swallowing the XARELTO tablet whole talk to your doctor about other ways to take XARELTO. Your doctor will decide how long you should take XARELTO. Your doctor may stop XARELTO for a short time before any surgery medical or dental procedure. Your doctor will tell you when to start taking XARELTO again after your surgery or procedure. Do not run out of XARELTO. Refill your prescription for XARELTO before you run out. When leaving the hospital following a hip or knee replacement be sure that you have XARELTO available to avoid missing any doses. If you take too much XARELTO go to the nearest hospital emergency room or call your doctor right away. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO See What is the most important information I should know about XARELTO Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA visit http or call FDA. You may also report side effects to Janssen Pharmaceuticals Inc. at JANSSEN . Please click here https for full Prescribing Information including Boxed Warnings and Medication Guide. Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban. For more information about XARELTO visit http About the Janssen Pharmaceutical Companies At the Janssen Pharmaceutical Companies of Johnson Johnson we are working to create a world without disease. Transforming lives by finding new and better ways to prevent intercept treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http Follow us on Twitter at JanssenUS httpstwitter.comjanssenus. Janssen Pharmaceuticals Inc. is part of the Janssen Pharmaceutical Companies of Johnson Johnson. Cautions Concerning ForwardLooking Statements This press release contains forwardlooking statements as defined in the Private Securities Litigation Reform Act of regarding product development and the presentation of new data and analyses regarding XARELTO rivaroxaban. The reader is cautioned not to rely on these forwardlooking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize actual results could vary materially from the expectations and projections of any of the Janssen Pharmaceutical Companies andor Johnson Johnson. Risks and uncertainties include but are not limited to challenges and uncertainties inherent in product research and development including the uncertainty of clinical success and of obtaining regulatory approvals uncertainty of commercial success manufacturing difficulties and delays competition including technological advances new products and patents attained by competitors challenges to patents product efficacy or safety concerns resulting in product recalls or regulatory action changes in behavior and spending patterns of purchasers of health care products and services changes to applicable laws and regulations including global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks uncertainties and other factors can be found in Johnson Johnsons Annual Report on Form K for the fiscal year ended December including in the sections captioned Item A. Risk Factors and Cautionary Note Regarding ForwardLooking Statements and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http http or on request from Johnson Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson Johnson undertakes to update any forwardlooking statement as a result of new information or future events or developments. i Colilla S et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am J Cardiol . ii American Heart Association April . Prevention Strategies for Atrial Fibrillation. Retrieved from http_UCM__Article.jsp.VvRBcuIrKUk http_UCM__Article.jsp iii Coleman CI Bunz TJ Eriksson D Meinecke AK and Sood NA. Effectiveness and safety of rivaroxaban vs warfarin in people with nonvalvular atrial fibrillation and diabetes an administrative claims database analysis. April doi .dme.httpsonlinelibrary.wiley.comdoiepdf.dme.. iv Perera V Bajorek BV Matthews S Hilmer SN. The impact of frailty on the utilisation of antithrombotic therapy in older patients with atrial fibrillation. Age Ageing . v Induruwa I Evans NR Aziz A Reddy S Khadjooi K RomeroOrtuno R. Clinical frailty is independently associated with nonprescription of anticoagulants in older patients with atrial fibrillation. Geriatr Gerontol Int . vi Lefebvre MC StOnge M GlazerCavanagh M Bell L Kha Nguyen JN VietQuoc Nguyen P Tannenbaum C. The effect of bleeding risk and frailty status on anticoagulation patterns in octogenarians with atrial fibrillation the FRAILAF study. Can J Cardiol . Media contact Sarah Freeman Mobile sfreemits.jnj.com mailtosfreemits.jnj.com Investor contacts Johnson Johnson Joseph J. Wolk Office Lesley Fishman Office SOURCE Janssen Pharmaceutical Companies of Johnson Johnson Related Links http"

"The disease is characterized by an itching oozing rash that can cover almost all of the skin. The constant itch to say nothing of the disfigurement can be so unbearable that many patients consider suicide. There has never been a safe and effective treatment. On Saturday the results of two large clinical trials of a new drug offered hope to the estimated . million adult Americans with an uncontrolled moderatetosevere form of the disease atopic dermatitis which is a type of eczema. Most patients who got the active drug dupilumab instead of a placebo reported that the itching began to wane within two weeks and was gone in a few months as their skin began to clear. Nearly percent of participants getting the drug saw all or almost all of their rash disappear. For some relief was almost instantaneous. I knew immediately I was on the drug and not the placebo said Daniela Velasco an event planner in Playa del Carmen Mexico. Within a couple of weeks the ugly red rash that had covered percent of her body was almost gone. Even better she said for the first time I didnt feel any itch at all. Before entering the trial Mrs. Velasco had seen doctors about the disease and tried dozens of drugs and treatments to no avail. To participate in the study she spent more than to fly to Mount Sinai in New York on a regular basis and stay in hotels. She realized she might get a placebo but also knew that when the study ended everyone including the placebo patients would be able get the drug if the trial was successful. The drug blocks two specific molecules of the immune system that are overproduced in patients with this and some other allergic diseases. The only side effects were a slight increase in conjunctivitis an inflammation of the outer membrane of the eye and swelling at the injection site. This is a landmark study said Dr. Mark Boguniewicz an atopic dermatitis expert at National Jewish Health and the University of Colorado School of Medicine who was not involved with the study. For us in atopic dermatitis we are entering a new era. The studies http lasting weeks and involving nearly people were published in the New England Journal of Medicine. Daniela Velascos arms left and top and legs below right before the treatment with dupilumab.CreditEmma GuttmanYassky Daniela Velascos arms left and top and legs below right before the treatment with dupilumab.CreditEmma GuttmanYassky Dr. George D. Yancopoulos the president and chief scientific officer at Regeneron which in partnership with Sanofi makes the drug said he expects the Food and Drug Administration to rule on dupilumab by March . The drugs brand name will be Dupixent. The agency has given the drug breakthrough status httpnewsroom.regeneron.comreleasedetail.cfmReleaseID which provides expedited development and review of drugs for serious or lifethreatening diseases. Editors Picks Dr. Yancopoulos declined to speculate on dupilumabs price saying only that it will be consistent with the value of the drug. It is a biologic the most expensive type of drug and is injected every two weeks. Atopic dermatitis experts said they have longed for a safe and highly effective treatment. In desperation some prescribed other drugs offlabel like powerful immunosuppressants or high doses of steroids which are far from ideal because even if they helped their side effects can be severe kidney failure with immunosuppressants bone loss and even psychotic breaks with highdose steroids. Patients are miserable Dr. Boguniewicz said. Our patients and families havent slept through the night not for days or weeks but for months or years. Many doctors provide no treatments other than perhaps creams and ointments that do not stop the itching or soothe the red and weeping rash said Dr. Jonathan I. Silverberg of Northwestern Universitys Feinberg School of Medicine and a principal investigator in one of the studies. Many sufferers can relate to the plight of the defense lawyer played by John Turturro in the HBO series The Night Of http He suffers from http atopic dermatitis that started on his legs and his feet and later spread to his neck and head. Like so many patients he tries treatment after treatment bleach baths covering the rash in Crisco and wrapping it with plastic wrap steroids Chinese medicine. He scratches it with chopsticks and disgusts people near him. But all to no avail. Such experiences explain the excitement over the new drug although researchers say they would like to see longerterm data. What we are seeing are some really impressive efficacy numbers Dr. Silverberg said. But efficacy alone is not enough. It is the safety profile that is the real key. Everything we are seeing really looks great. Sign up for Science Times Well bring you stories that capture the wonders of the human body nature and the cosmos. Dr. Jon M. Hanifin a professor of dermatology at Oregon Health and Science University and founder of the National Eczema Association agreed. While not a principal investigator in the study Dr. Hanifin did oversee the care of some patients enrolled in it. Herb Bull at a friends home in Westfield N.J. He said the new drug saved his life.CreditBryan Anselm for The New York Times Herb Bull at a friends home in Westfield N.J. He said the new drug saved his life.CreditBryan Anselm for The New York Times Its wonderful he said. We walk in the room and patients are smiling. These patients are the worst of the worst. Their life was destroyed. Dr. Yancopoulos was inspired in part to develop the drug because his father had severe atopic dermatitis which he developed shortly after he got lung cancer at . More so than the cancer and the chemo this rash and its horrible itch started dominating his life and ruining its quality Dr. Yancopoulos said. Heres a guy with Stage IIIB lung cancer basically a death sentence and he is more concerned and miserable about his skin and his itch. One participant in the trial Lisa Tannebaum a yearold harpist in Stamford Conn. was so thrilled that she wrote a letter to Regeneron suggesting they use her before and after photographs in advertisements. She developed a severe form of the disease years ago and tried everything imaginable in conventional and alternative medicine without relief specialized diets immunosuppressive drugs special clothing bleach baths. She even had the gold fillings removed from her teeth on the theory that they may be causing an allergic response but to no avail. It was like every day I had poison ivy and fire ants on myself she said. You dont sleep at all. You cant go out you have staph infections all the time because the skins protective barrier is broken by the rash. I couldnt drive my kids to school because the itching was so bad I couldnt put my hands on the steering wheel. Now she is performing again and will be playing her harp at Carnegie Hall on Oct. https Herb Bull a retired Merck scientist in Westfield N.J. had mild atopic dermatitis for years until three years ago when it took a turn for the worse. The rash covered his entire body. Sleep was impossible itching a constant torment. Even walking was difficult. Advertisement He had weeping lesions all over his body said his doctor Dr. Emma GuttmanYassky a principal investigator in the trial and professor of dermatology and immunology at the Icahn School of Medicine at Mount Sinai. I thought I might as well give up and die Mr. Bull said. It took months for the drug to work he said but when it did the change was miraculous. His rash and the itching went away. The new drug Mr. Bull said saved my life."

"Orlando Fla Researchers at Orlando Health have developed a blood test that can detect even the most subtle signs of a concussion in children correctly identifying the presence of traumatic brain injuries percent of the time in a recent study. This could ultimately change the way we diagnose concussions not only in children but in anyone who sustains a head injury said Linda Papa MD MSC an emergency medicine physician and NIH funded researcher at Orlando Health and lead author of the study. We have so many diagnostic blood tests for different parts of the body like the heart liver and kidneys but theres never been a reliable blood test to identify trauma in the brain. We think this test could change that she said. In a new study published in the journal Academic Emergency Medicine Papa and her team recently performed CT scans on children and compared the results of those scans with results from the blood test she developed. As expected the high definition imagery from the CT scans was able to identify which patients had suffered visible traumatic brain injuries. Moreover the study showed that the blood test detected symptoms of concussions even when brain injuries were not visible on the CT scan. The team then tested blood serum from the same patients which was taken less than hours after their injuries. With our blood test we were able to identify the presence of brain injuries percent of the time said Papa. This simple blood test was nearly as accurate as a stateoftheart CT scan. Even more impressive the blood test also gave doctors an indication of how severe the brain injury was. We were looking at different types of brain lesions detected by the CT scans ranging from mild to serious injuries and found that the biomarker we tested for actually corresponded to the injuries. Levels of the biomarker were lower in mild cases and were much more elevated in severe case said Papa. The biomarker this particular blood test looks for is known as glial fibrillary acidic protein GFAP. These proteins are found in glial cells which surround neurons in the brain. When theres an injury to the brain cells the GFAP are released. What makes them unique is that they pass the bloodbrain barrier and enter the bloodstream which makes them easy to detect with this particular test. Currently almost all concussions in children are diagnosed only by symptoms which are either observed like vomiting or balance problems or symptoms that are reported by the child like headaches blurred vision or feeling groggy. Neither scenario gives doctors an objective indication of the severity of the injury. CT scans can provide a more definitive profile of the injury however they are expensive and are associated with radiation exposure said Papa. You really want to minimize the amount of CTs you do to your patients especially children who are a lot more sensitive to radiation and the side effects that can come with it. If there was a simple diagnostic tool like a blood test that can tell us quickly and accurately if a brain injury has occurred and how severe it might be that would be ideal said Papa. Thats what we are striving for with this project. In fact Papa envisions the development of mobile devices that could diagnose concussions on the spot much like the devices diabetics use to test their blood with a simple finger prick and a drop of blood. The idea is to get a pointofcare test that could be used on the field to help the coaches the trainers and the athletic directors make a decision then and there about whether the child should go back to play said Papa. Its estimated nearly a quarter of a million children a year are treated in hospitals for traumatic brain injuries like concussions that occur while playing sports. Thats an average of nearly children a every day. If we could find a simple test that takes the guess work out of diagnosing these kids that would completely change the way we approach concussions and would certainly give parents greater peace of mind said Papa. Researchers plan to do more studies with the blood test but they hope it will be commercially available within the next years."

"In what the authors describe as the largest and longest study of resveratrol in people with mild to moderate Alzheimers disease theres encouraging news that the component which is found in red wine grapes and dark chocolate may keep the disease from progressing. Dr. R. Scott Turner professor of neurology and director of the memory disorders program at Georgetown University Medical Center and his team created a purified form of resveratrol which is being studied in both animal and human studies for preventing agerelated conditions such as diabetes and cancer. In a study published in Neurology he described how they randomly assigned half of a group of men and women to take up to mg of resveratrol daily and the other half to a placebo for a year. All of the participants had mild or moderate Alzheimers disease. At the end of the year Turner compared the peoples scores on cognitive tests and assessments of how independent they were in their daily living from the start of the study. My nightmare was that nothing would be different from the placebo group and there would be nothing of interest to talk about he says. But that did not happen. I think resveratrol is an engaging target thats very interesting and could be pharmacologically manipulated to develop a treatment. MORE Red Wine Not That Healthy After All Study Shows httptime.comredwinehealthystudy The resveratrol group showed no change in the levels of a protein that builds up in the brains of Alzheimers patients. Turners group also measured the protein in spinal fluid and blood and did not see differences over the year in the resveratrol group. Thats likely because experts believe that as Alzheimers progresses more of the protein plaques form in the brain and less of the protein is released to the rest of the body. The resveratrol group also showed smaller brain volume which in the case of Alzheimers is a positive sign as the disease can cause inflammation and swelling that can interfere with nerve connections. MORE Noteworthy Advances in Alzheimers Research httptime.comnoteworthyadvancesinalzheimersresearch Even more encouraging the people who were treated showed slight improvements in their ability to maintain certain daily activities on their own such dressing and bathing themselves. How resveratrol may be affecting the Alzheimers disease process isnt clear yet. Turner says the findings dont suggest that red wine is a cure for Alzheimers. The amounts of resveratrol in the purified doses that the participants took were extremely high and beyond those found on the market currently around what would be contained in about bottles of red wine. Plus he says resveratrol supplements currently available over the counter are unregulated and we dont know how much is in it. We need more studies to see if it really does have benefit and then it could be turned into more effective drugs that can better target Alzheimers. Horrible Habits You Need to Stop Right Now next of Do Not Email First Thing in the Morning or Last Thing at Night The former scrambles your priorities and all your plans for the day and the latter just gives you insomnia says Ferriss who insists email can wait until am or after you check off at least one substantive todo list item. Chris PecoraroGetty Images You Might Like Stars Walk the Golden Globes Red Carpet Expensive Red Carpet Outfits Correction The original version of this story misstated that all the participants were men. The study included men and women."

"Debbie Spina is a supervisor for the radiology department at the Hospital for Joint Diseases at the NYU Langone Medical Center in New York City. But when CBS News met her this spring she was a patient who was about to undergo sameday hip replacement surgery. The yearold had been having hip pain for the past two years because of arthritis. She had heard a lot of positive feedback from people who had undergone hip replacement surgery https at her hospital. A big attraction for her was the possibility of going home right after the surgery. The option to go home the same day and have that family around me was something that I wanted to do said Spina. She believed she would be able to recuperate more comfortably at home and get back on her feet faster. At most hospitals hip replacement https patients can expect a one to threenight hospital stay. Total hip replacement surgery is increasingly common with more than procedures done every year in the U.S. The surgery is meant to restore range of motion and help relieve arthritic pain. The procedure consists of removing the patients worn out ball and socket joint and inserting an artificial socket. On the femur side a stem is inserted into the bone and a ball is on the tip of it. NYU Langone Medical Center said it became the first academic medical center in New York City to implement a sameday hip replacement program in . Dr. Roy Davidovitch director of NYU Langones Hip Center said he performs around hip replacements a year and approximately percent of those patients will go home the same day. Davidovitch said patients are happier going home sooner. Nothing beats the comfort of your own home for recovery. And to be quite honest if the pain is controlled and the patient is healthy and medically completely stable there is no reason for them to be in the hospital. It really doesnt make sense. There are two common surgical approaches for a total hip replacement anterior which involves entering surgically through the front of the hip and posterior or entering surgically through the side or buttocks. According to research done by the American Academy of Orthopaedic Surgeons http there are no significant differences between either approach in recovery outcomes six months after surgery. Davidovitch favors the anterior approach which he believes has a faster and less painful recovery period in the short term because doctors dont have to cut through muscles or tendons to get to the hip like in the posterior approach. He does agree that in the long term both procedures have the same outcomes for patients. But its not the surgical approach alone that allows some of his patients to go home the same day its a combination of what happens before during and after surgery. At NYU Langone patients have to do whats called prehab. Before the surgery they work with an occupational and physical therapist to learn information on the procedure learn exercises to do after the surgery and how to properly move around while they are recovering. During the surgery Davidovitch uses a shortacting spinal anesthetic that lasts about hours and when closing the wound he injects a cocktail of medications to help with the inflammation and pain. Patients can be up and walking usually within three hours after the surgery. But they must have someone around the first night they are spending at home postsurgery. The people who are against the whole idea for sameday discharge for hip replacement are concerned about the very rare instances where somebody could develop a blood clot that goes to the lung or a fracture of some sort said Davidovitch. The rates of blood clots or pulmonary emboli is exceedingly low. And in general if a patient is identified as a high risk or a higher risk we dont send them home the same day. Davidovitch makes it clear that this kind of surgery is not onesizefitsall. Patients are screened first to make sure they dont have risk factors like obesity chronic liver disease or cardiac problems https Those who have risk factors must plan on staying overnight in the hospital not going right home. However not every surgeon is embracing the sameday trend. Douglas E. Padgett M.D. chief of the joint replacement service at Hospital for Special Surgery in New York is a lot more conservative about who he believes is the optimal patient for going home the same day. The number of patients that are going home at this point in time in our institution is somewhere between one and two percent. So its a relatively small percentage of patients that are going directly home said Padgett. Padgett has seen an increase in the number of hip replacement patients and a decrease in their age some are as young as their s and s. He said his department performs the most hip replacements of any institution in the U.S. doing about a year. While he is not against patients going home the same day he cautions that total joint replacement is a major procedure and doctors need to be careful to avoid sending patients home too soon. While I recognize there is no place like home should there be the need for urgent or medical care the question is will that be available to the patient when theyre in the setting of their own home Padgett said. Debbie Spina met all the requirements to go home the same day. Her surgery lasted about an hour which is the average time for her type of procedure. After the the operation she was able to move around but felt dizzy and nauseous. The occupational and physical therapists waited until evening to try and get her to go up and down steps and walk around which patients must be able to do before they are discharged. But Spina didnt feel well enough so she actually ended up spending the night. Even though her sameday discharge didnt go as planned Spina felt good the following morning and was able to do her exercises and leave the hospital. After her recovery is complete she has a few goals shed like to reach. I had walked prior to this four miles every morning Id like to do that. And Id like to improve my golf game if possible Spina said while smiling. Davidovitchs goal is for patients to return to their normal level of activity as quickly as possible. And with many people wanting to maintain active lifestyles well into their s and beyond he expects to see even greater demand for hip replacement surgery and the sameday option. In general I see this growing to about percent of my practice he said."

"Eli Lilly and Cos new Jardiance pill slashed deaths by percent in patients with type diabetes at risk of heart attack and stroke a finding that could make it a mainstay diabetes treatment and triple its use according to researchers and analysts. Lilly shares jumped as much as percent after data from the trial was released Thursday at a medical meeting in Stockholm. This is the first diabetes therapy to show robust effect in reducing cardiovascular death. It really is big news said Dr. Bernard Zinman director of the Diabetes Centre at Mount Sinai Hospital in Toronto who led the threeyear study of people. Because about onehalf of the deaths in people with type diabetes are caused by cardiovascular disease reducing cardiovascular risk is considered essential to diabetes care. Type diabetes is the most common form of the disease and is linked to obesity. Jardiance a onceaday pill which won U.S. approval last year belongs to a new family of treatments called SGLT inhibitors that include Johnson Johnsons Invokana and AstraZeneca Plcs Farxiga. They lower blood sugar by inhibiting reabsorption of glucose in the kidneys. Jardiance was developed jointly with Germanys privately held Boehringer Ingelheim. Zinman in an interview predicted the new study would prompt medical societies to recommend that Jardiance be used by type diabetics who have a history of heart disease or who are at risk of cardiovascular events. About million Americans have type diabetes according to federal data for . The vast majority of those patients could be candidates for Jardiance which costs over per year Morningstar analyst Damien Conover said. The big news here is that the drug reduced cardiovascular stuff. That has not been the case with all things in diabetes said David Marrero president of health care and education at the American Diabetes Association. It is probably going to be a more popular drug because of that. JARDIANCE COULD BOOST EARNINGS Sanford Bernstein analyst Tim Anderson more than tripled his annual sales forecast for Jardiance and combination drugs containing it to . billion by . He cut his sales forecast for Merck Co Incs Januvia the leading member of a competing class of oral diabetes drugs called DPP inhibitors to billion from . billion. Anderson estimates Jardiance could boost Lillys earnings per share by percent on average across to . In the study patients taking Jardiance had a percent reduction in cardiovascular death including from heart attacks and strokes. There was no significant difference in nonfatal heart attacks or nonfatal strokes. Those taking Jardiance had a percent lower risk of dying from any cause and a percent lower rate of hospitalizations from heart failure. The benefits were especially impressive because they added to protection that patients received from taking cholesterol fighters and other lifesaving heart drugs Zinman said. This is a wonderful thing said Dr. Jerome Tolbert of Mount Sinai Beth Israel Hospital in New York. He has not prescribed Jardiance and similar drugs as frequently as treatments like Januvia but expects that may change based on the new data. Zinman noted that Jardiance like other SGLT drugs causes weight loss and reduced blood pressure besides lowering both blood sugar levels and body fat and also reduces swelling which all help the cardiovascular system. Lilly and Boehringer last month disclosed that Jardiance met its primary study goal becoming the first diabetes drug to show heartprotective results in a large cardiovascular trial. But they did not unveil detailed data until Thursday at the medical meeting. Shares of Lily closed up . percent at . on Thursday after rising as high as .. In calculating the combined number of cardiac deaths nonfatal heart attacks and nonfatal strokes percent fewer events were seen in patients taking Jardiance in combination with standard treatments compared with patients who took standard treatments alone meeting the studys main goal. Standard treatments included statins which lower cholesterol and blood pressure drugs. Reporting by Ransdell Pierson in New York Additional reporting by Deena Beasley in Los Angeles Editing by Michele Gershberg Jeffrey Benkoe and Lisa Shumaker"

"Two drugs already on the market an antifungal and a steroid may potentially take on new roles as treatments for multiple sclerosis. According to a study published in Nature today researchers discovered that these drugs may activate stem cells in the brain to stimulate myelin producing cells and repair white matter which is damaged in multiple sclerosis. The study was partially funded by the National Institute of Neurological Disorders and Stroke NINDS part of the National Institutes of Health. Specialized cells called oligodendrocytes lay down multiple layers of a fatty white substance known as myelin around axons the long wires that connect brain cells. Myelin acts as an insulator and enables fast communication between brain cells. In multiple sclerosis there is breakdown of myelin and this deterioration leads to muscle weakness numbness and problems with vision coordination and balance. To replace damaged cells the scientific field has focused on direct transplantation of stem cellderived tissues for regenerative medicine and that approach is likely to provide enormous benefit down the road. We asked if we could find a faster and less invasive approach by using drugs to activate native nervous system stem cells and direct them to form new myelin. Our ultimate goal was to enhance the bodys ability to repair itself said Paul J. Tesar Ph.D. associate professor at Case Western Reserve School of Medicine in Cleveland and senior author of the study. It is unknown how myelinproducing cells are damaged but research suggests they may be targeted by malfunctioning immune cells and that multiple sclerosis may start as an autoimmune disorder. Current therapies for multiple sclerosis include antiinflammatory drugs which help prevent the episodic relapses common in multiple sclerosis but are less effective at preventing longterm disability. Scientists believe that therapies that promote myelin repair might improve neurologic disability in people with multiple sclerosis. Adult brains contain oligodendrocyte progenitor cells OPCs which are stem cells that generate myelinproducing cells. OPCs are found to multiply in the brains of multiple sclerosis patients as if to respond to myelin damage but for unknown reasons they are not effective in restoring white matter. In the current study Dr. Tesar wanted to see if drugs already approved for other uses were able to stimulate OPCs to increase myelination. OPCs have been difficult to isolate and study but Dr. Tesar and his colleagues in collaboration with Robert Miller Ph.D. professor at George Washington University School of Medicine and Health Sciences in Washington D.C. developed a novel method to investigate these cells in a petri dish. Using this technique they were able to quickly test the effects of hundreds of drugs on the stem cells. The compounds screened in this study were obtained from a drug library maintained by NIHs National Center for Advancing Translational Sciences NCATS. All are approved for use in humans. NCATS and Dr. Tesar have an ongoing collaboration and plan to expand the library of drugs screened against OPCs in the near future to identify other promising compounds. Dr. Tesars team found that two compounds in particular miconazole an antifungal and clobetasol a steroid stimulated mouse and human OPCs into generating myelinproducing cells. Next they examined whether the drugs when injected into a mouse model of multiple sclerosis could improve remyelination. They found that both drugs were effective in activating OPCs to enhance myelination and reverse paralysis. As a result almost all of the animals regained the use of their hind limbs. They also found that the drugs acted through two very different molecular mechanisms. The ability to activate white matter cells in the brain as shown in this study opens up an exciting new avenue of therapy development for myelin disorders such as multiple sclerosis said Ursula Utz Ph.D. program director at the NINDS. Dr. Tesar and his colleagues caution that more research is needed before miconazole and clobetasol can be tested in multiple sclerosis clinical trials. They are currently approved for use as creams or powders on the surfaces of the body but their safety administered in other forms such as injections in humans is unknown. Offlabel use of the current forms of these drugs is more likely to increase other health concerns than alleviate multiple sclerosis symptoms. We are working tirelessly to ready a safe and effective drug for clinical use Dr. Tesar said. This work was supported by the NINDS NS NS NS the New York Stem Cell Foundation and the Myelin Repair Foundation New York City. The NINDS http is the nations leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The National Center for Advancing Translational Sciences is a distinctly different entity in the research ecosystem. Rather than targeting a particular disease or fundamental science NCATS focuses on what is common across diseases and the translational process. The Center emphasizes innovation and deliverables relying on the power of data and new technologies to develop demonstrate and disseminate advancements in translational science that bring about tangible improvements in human health. For more information visit http About the National Institutes of Health NIH NIH the nations medical research agency includes Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic clinical and translational medical research and is investigating the causes treatments and cures for both common and rare diseases. For more information about NIH and its programs visit https NIHTurning Discovery Into Health Reference Najm et al. Drugbased modulation of endogenous stem cells promotes functional remyelination in vivo Nature April ."

"A single breath may be all it takes to identify the return of lung cancer after surgery according to a study posted online today by The Annals of Thoracic Surgery. Exhaled breath contains thousands of volatile organic compounds VOCs that vary in composition and pattern depending on a persons health status. A subset of four VOCscalled carbonyl compounds because of their carbon basehave been discovered in the exhaled breath of lung cancer patients. Being able to identify this lung cancer signature through a simple breath test has emerged as one of the most promising ways to diagnose the disease. Now the test is being used to monitor for disease recurrence. Erin M. Schumer MD MPH Victor van Berkel MD PhD and colleagues from the University of Louisville analyzed breath samples collected before and after surgery from lung cancer patients and compared their carbonyl VOCs levels with samples from healthy patients. The researchers found a significant decrease in overall carbonyl VOC levels following surgery in fact three of the four carbonyl VOCs normalized after surgery matching levels in the control group. The rapid normalization of almost all of the four compounds after surgery provides strong evidence that they are directly produced by the tumor environment said Dr. Schumer. This study confirms that the technology is accurate. Lung cancer is the leading cause of cancer death. The American Cancer Society ACS estimates that more than Americans will be diagnosed with lung cancer this year and more than lung cancer patients will diethat translates to lung cancer deaths per day in the United States. Dr. Schumer said those grim statistics underscore the need for early detection We hope that breath analysis will allow us to diagnose patients with primary or recurrent lung cancer long before they suffer from symptoms when we have more options for treating them giving them the best chance for cure. Currently lung cancer patients are followed after surgery with chest computed tomography CT scans which can be inconvenient expensive and expose the patient to radiation. We hope that the breath analysis can serve as the primary screening tool for cancer recurrence and a CT scan ordered only if the breath test suggests that there has been a change said Dr. van Berkel. How the Breath Test WorksThe process of breath analysis is relatively simple. The patient blows a single breath into a specialized balloon. The balloon is then connected to a pump that pulls the breath over a small microchip smaller than a quarter trapping the chemicals. The microchip is sent to the lab where the chemicals are analyzed within hours. Breath collection can be performed in the doctors office. The pump is reusable the balloon microchip and lab test together cost around all supporting the increasing acceptance of breath tests as a costeffective easytoperform noninvasive and rapid option for the diagnosis of lung cancer. The great potential with breath analysis is detecting lung cancer at any point both as a primary screening tool and to follow patients after disease has been treated said Dr. van Berkel. The technology is pretty robust. Our next step is getting approval from the FDA. Schumer E Black M Bousamra M Trivedi J Li M Fu X van Berkel V. Normalization of Exhaled Carbonyl Compounds Following Lung Cancer Resection. Ann Thoracic Surg DOI .j.athoracsur.... Note This work was supported by the Coulter Foundation V Foundation National Science Foundation and Bill and Melinda Gates Foundation. In addition Drs. Bousamra van Berkel and Fu disclose a financial relationship with Breath Diagnostics Inc. For a copy of The Annals article contact Jennifer Bagley at or jbagleysts.org. Founded in The Society of Thoracic Surgeons is a notforprofit organization representing more than cardiothoracic surgeons researchers and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart lung and esophagus as well as other surgical procedures within the chest. The Societys mission is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education research and advocacy. The Annals of Thoracic Surgery is the official journal of STS and the Southern Thoracic Surgical Association. It has a year impact factor of . the highest of any cardiothoracic surgery journal worldwide."

"Scientists at St. Jude Childrens Research Hospital have discovered how an immune system protein called AIM Absent in Melanoma plays a role in determining the aggressiveness of colon cancer. They found that AIM deficiency causes uncontrolled proliferation of intestinal cells. Surprisingly they also discovered that AIM influences the microbiota the population of gut bacteria apparently fostering the proliferation of good bacteria that can protect against colon cancer. The team led by ThirumalaDevi Kanneganti Ph.D. a member of the St. Jude Department of Immunology published their findings in a recent issue of the journal Cell. She said that the findings could have important applications for prevention prognosis and treatment. Since reduced AIM activity in colorectal cancer patients is associated with poor survival it might be useful to detect the level of AIM expression in polyps taken from colonoscopy and use this as one of the biomarkers for prognosis Kanneganti said. Kanneganti and her team believe that it might be possible to prevent the disease or reduce its risk by treating susceptible people to increase AIM activity and give them healthy donor bacteria. In people who already have colorectal cancer therapies that boost the expression of AIM such as interferons might reduce tumor progression. Also transferring healthy microbiota or a group of good bacteria to patients with colorectal cancer at the early stage of disease may prolong survival Kanneganti said. Cancer researchers had known that mutations in AIM were frequently found in patients with colorectal cancers. And a study by other researchers had found that more than half of small bowel tumors had AIM mutations. However AIMs established function in the cell was not in the machinery of cancer said one of the papers first authors Si Ming Man Ph.D. a postdoctoral fellow in Kannegantis laboratory. Rather he said AIM was known to work in the immune system to detect invading bacteria and viruses and help alert the immune system to battle them. When we found that the intestine expressed high levels of AIM we hypothesized that this gene may also play a role in regulating gut health Man said. This was how we became interested in AIM and colorectal cancer. In their experiments with mice the scientists used chemicals to trigger the process mimicking the development of colorectal cancer. They found that the mice showed drastically reduced AIM function confirming the finding in humans with the cancer. They also found that mice genetically altered to have reduced AIM function when treated with the chemicals showed significantly more tumors than normal mice. The scientists studies also showed that AIM played a role independent of its immune role in suppressing abnormal expansion of intestinal stem cell populations. Conversely malfunction of AIM unleashes abnormal stem cell proliferation. Stem cells are immature cells that differentiate into adult cells such as intestinal cells. These cells continuously proliferate to replace old and dying cells in the intestine. Many previous studies have indicated that AIM contributes to the immune system by acting as a pathogen sensor Man said. However our work is the first to identify AIMs role in controlling proliferation of intestinal stem cells. This work is truly exciting to us because we have found a new role for AIM in regulating colorectal cancer and it does so by inhibiting excessive proliferation of stem cells in the large intestine. The researchers also pinpointed the specific cellular machinery regulated by AIM. They decided to explore whether AIMs protective role might involve gut bacteria based on studies from Kannegantis lab and others indicating that microbial sensors similar to AIM contributed to healthy gut microbiota. Indeed the comparison of gut bacteria in normal and AIMdeficient mice showed a different microbial landscape in the two types of mice. To test whether gut bacteria might influence the progression of colon cancer the researchers housed normal and AIMdeficient mice together to enable the exchange of gut bacteria. The scientists found a striking reduction in colon tumors in the AIMdeficient mice and an increase in tumors in the normal mice. What this might suggest is that transfer of some of the good microbiota from wildtype mice to replace the bad microbiota from mice lacking AIM offers increased protection against colorectal cancer Man said. We believe that this finding has important clinical relevance because we can potentially prevent or decelerate the progression of colorectal cancer in humans especially in those who have mutations in the AIM gene by simply giving them good microbiota. We have only scratched the surface of the role of AIM in controlling stem cell proliferation and the maintenance of a healthy gut microbiota Kanneganti said. How exactly AIM does both of these functions is an exciting research area to pursue. The papers other authors are Qifan Zhu Liqin Zhu Zhiping Liu Rajendra Karki Ankit Malik Deepika Sharma Liyuan Li R.K. Subbarao Malireddi Prajwal Gurung Geoffrey Neale Scott Olsen Robert Carter Daniel McGoldrick Gang Wu David Finkelstein Peter Vogel and Richard Gilbertson all of St. Jude. The research was funded in part by grants AR CA AI from the National Institutes of Health and ALSAC. Contact Carrie Strehlau carrie.strehlaustjude.org mailtocarrie.strehlaustjude.org Desk or Cell Frannie Marmorstein frannie.marmorsteinstjude.org mailtofrannie.marmorsteinstjude.org Desk or Cell About St. Jude Childrens Research Hospital St. Jude Childrens Research Hospital is leading the way the world understands treats and defeats childhood cancer and other lifethreatening diseases. It is the only National Cancer Institutedesignated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from percent to percent since the hospital opened more than years ago. St. Jude is working to increase the overall survival rate for childhood cancer to percent in the next decade. St. Jude freely shares the breakthroughs it makes and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment travel housing and food because all a family should worry about is helping their child live. To learn more visit stjude.org http or follow St. Jude at stjuderesearch http"

"Alex Pierce took up distance running with great enthusiasm a couple of years ago. Then she developed knee pain so severe that she could not climb stairs. So Pierce a doctoral student in food science went to see physical therapist Matt Briggs at The Ohio State Wexner Medical Center in Columbus. He performed deep massages suggested changes in her running form and taught her how to exercise her thigh and gluteal muscles to better protect her knees. She believes all of that helped. But Pierce like a growing number of patients had another treatment she is convinced helped even more. Its called dry needling and it involves the insertion of thin nonmedicated solid needles into muscles or connective tissues. Proponents say it can reduce pain and improve movement. Pierce has had the procedure more than half a dozen times and believes it is one reason she will be able to run her fourth marathon in November. This has kind of changed my life she says. Testimonials like that are a big reason dry needling has caught on with some physical therapists athletes and other patients Briggs says. But testimonials are not scientific proof. And there Briggs says is where dry needling is lacking. While some studies have shown promise he says the quality of the evidence is not strong. Thats why Briggs and his colleagues are starting a study looking at dry needling in runners knee the condition that has plagued Pierce. Their goal and the goal of other researchers now looking at dry needling is to produce results rigorous enough to show whether it really works. For now heres what consumers should know Is this acupuncture Physical therapists say it is not though superficially it may look the same says Justin Elliott vice president of government affairs for the American Physical Therapy Association http For one thing he says dry needling as performed by a physical therapist is not rooted in ancient Chinese medicine theres no talk about redirecting the bodys energy flow by placing needles at certain points in the body. Instead needles are placed directly in problem areas. Elliott says dry needling also is practiced by some chiropractors naturopathic physicians and nurses which puts it outside the realm of any one specialty. Acupuncturists beg to differ. What is being called dry needling is clearly a form of acupuncture and should be done only by professionals extensively trained in that discipline says Thomas Burgoon a West Chester Pa. physician who is president of the American Academy of Medical Acupuncture http He says many acupuncturists do exactly what the physical therapists describe with the same kind of needles. Burgoons group has persuaded some states to bar physical therapists from the practice. How might it work One theory is that the needles cause tight muscles to twitch then relax. The needles may also increase blood flow or set off nerve responses that alter pain perception Briggs says. Another possibility Its a placebo effect an improvement triggered by the expectation that a treatment will work rather than by the treatment itself. To look for that possibility the Ohio State study will compare patients who get the real needle treatment to those poked with sham needles that dont pierce the skin. Mark Crislip an infectiousdisease doctor in Portland Ore. who recently wrote about dry needling for ScienceBased Medicine https a website critical of alternative medicine says the version practiced by physical therapists doesnt come with the mystical baggage that accompanies acupuncture. But he says it may well be a theatrical placebo. What do published studies say Its a mixed bag Elliott says. In a review httpfileCUserskpainterDownloadsDryNeedlingResourcePaper.pdf the physical therapy association rated the evidence for dry needling a out of based on the best studies. A formal analysis http_acupunctureanddryneedlingforlowbackpain of trails on acupuncture and dry needling for chronic lower back pain was published by the Cochrane research group in . It found they may be useful additions to standard treatment. But it said higher quality studies were needed. What are the risks Needling can produce minor bleeding and some soreness but in trained hands and with the use of sterile needles and gloves its a very safe procedure Briggs says. In rare cases deep needling can lead to a punctured lung or injuries to nerves and blood vessels and acupuncturists fear nonspecialists will be more likely to make such mistakes Burgoon says. Will insurers pay for this Many will not. Charges for patients can range from to per session says Edo Zylstra CEO of KinetaCore a company that offers intensive threeday weekend courses in dry needling to physical therapists. Do all physical therapists offer this No. The physical therapy association tells members in seven states to steer clear because of recent court or regulatory decisions or language in existing licensing laws. They are California Florida Hawaii Idaho New York South Dakota and Washington. And most of the nations licensed physical therapists are not trained in the technique. About have taken courses in dry needling in the past few years Zylstra says."

"Video commentary from researchers and broll are available at httpbcove.mettyxtcl. A media teleconference with researchers and patients will also be held on Wednesday Nov. from a.m. EST to p.m. EST. To participate U.S.based media can call international media should dial . The access code is . Phone lines open at a.m. and all media should place speakers on mute unless posing a question. Reporters wishing to ask a question should email their name and outlet to david.marchnyumc.org mailtodavid.marchnyumc.orgsubjectNewswiseArticleReporterFollowupbccreportersnewswise.com during the briefing so they may be placed in a queue the moderator will call on individual media to ask a question in the order names and outlets were received. Newswise When combined with psychological counseling a single dose of a mindaltering compound contained in psychedelic mushrooms significantly lessens mental anguish in distressed cancer patients for months at a time according to results of a clinical trial led by researchers at NYU Langone Medical Center. Published in the Journal of Psychopharmacology online Dec. the study showed that onetime treatment with the hallucinogenic drug psilocybin whose use required federal waivers because it is a banned substance quickly brought relief from distress that then lasted for more than six months in percent of the study subjects monitored based on clinical evaluation scores for anxiety and depression. The NYU Langoneled study was published side by side with a similar study from Johns Hopkins. Study results were also endorsed in accompanying editorials from leading experts in psychiatry addiction and palliative care. Our results represent the strongest evidence to date of a clinical benefit from psilocybin therapy with the potential to transform care for patients with cancerrelated psychological distress says study lead investigator Stephen Ross MD director of substance abuse services in the Department of Psychiatry at NYU Langone. If larger clinical trials prove successful then we could ultimately have available a safe effective and inexpensive medication dispensed under strict control to alleviate the distress that increases suicide rates among cancer patients says Ross also an associate professor of psychiatry at NYU School of Medicine. Study coinvestigator Jeffrey Guss MD a clinical assistant professor of psychiatry at NYU Langone notes that psilocybin has been studied for decades and has an established safety profile. Study participants he says experienced no serious negative effects such as hospitalization or more serious mental health conditions. Although the neurological benefits of psilocybin are not completely understood it has been proven to activate parts of the brain also impacted by the signaling chemical serotonin which is known to control mood and anxiety. Serotonin imbalances have also been linked to depression. For the study half of the participants were randomly assigned to receive a . milligrams per kilogram dose of psilocybin while the rest received a vitamin placebo milligrams of niacin known to produce a rush that mimics a hallucinogenic drug experience. Approximately half way through the studys monitoring period after seven weeks all participants switched treatments. Those who initially received psilocybin took a single dose of placebo and those who first took niacin then received psilocybin. Neither patients nor researchers knew who had first received psilocybin or placebo. Guss says The randomization placebo control and doubleblind procedures maximized the validity of the study results. One of the key findings was that improvements in clinical evaluation scores for anxiety and depression lasted for the remainder of the studys extended monitoring period specifically eight months for those who took psilocybin first. All patients in the study mostly women age to who are or were patients at the Perlmutter Cancer Center of NYU Langone had either advanced breast gastrointestinal or blood cancers and had been diagnosed as suffering from serious psychological distress related to their disease. All patients who volunteered to be part of the study were provided with tailored counseling from a psychiatrist psychologist nurse or social worker and were monitored for side effects and improvements in their mental state. Coinvestigator Anthony Bossis PhD a clinical assistant professor of psychiatry at NYU Langone says patients also reported postpsilocybin improvements in their quality of life going out more greater energy getting along better with family members and doing well at work. Several also reported variations of spirituality unusual peacefulness and increased feelings of altruism. Our study showed that psilocybin facilitated experiences that drove reductions in psychological distress says Bossis. And if its true for cancer care then it could apply to other stressful medical conditions. Bossis cautions that patients should not consume psilocybin on their own or without supervision by a physician and a trained counselor. He also says Psilocybin therapy may not work for everyone and some groups such as people with schizophrenia as well as adolescents should not be treated with it. Both the NYU Langone and Johns Hopkins studies were principally funded by the Heffter Research Institute a nonprofit scientific institution with the principal mission of helping to design review and fund studies on the use of psilocybin for a wide range of ailments Ross previously served as a board member. Additional funding for the NYU Langone study was provided by the National Center for Advancing Translational Sciences part of the National Institutes of Health UL TR. The drug used in the study was manufactured by Organix Inc. in Woburn Mass. Besides Ross Guss and Bossis other NYU researchers involved in this study are Gabrielle AginLiebes BS Tara Malone MA Alexander Belser MPhil Krystallia Kalliontzi MSc Barry Cohen PhD Sarah Mennenga PhD James Babb PhD Zhe Su MS MA Patricia Corby DDS and Brian Schmidt MD PhD. Media Inquiries David MarchJim Mandlerdavid.marchnyumc.org mailtodavid.marchnyumc.orgsubjectNewswiseArticleReporterFollowupbccreportersnewswise.comjim.mandlernyumc.org mailtojim.mandlernyumc.orgsubjectNewswiseArticleReporterFollowupbccreportersnewswise.com"

"For men who believe size matters and that their penises dont measure up success can be found in certain nonsurgical penile lengthening treatments a new study analysis by Italian researchers contends. Concerned that patients were seeking out unproven and potentially dangerous ways of lengthening the penis the researchers examined the medical literature to see whether popular nonsurgical methods had any scientific basis. In a review of five evidencebased surgical studies of men and six nonsurgical studies of men published between and the researchers found that penile extenders which stretch the organ over a period of months through traction were the most effective among noninvasive methods. But one expert cautioned that men are playing with fire if they tinker with their penis size simply for vanitys sake. Dr. Elizabeth Kavaler a urologist at Lenox Hill Hospital in New York City said functional issues resulting from conditions such as birth defects or prostate cancer surgery may warrant penile surgery but such cases are unusual. Its a very fragile organ to begin with Kavaler said and if you start to do all these things to it you can disfigure it... They should leave it alone. Study coauthor Dr. Paolo Gontero said urologists are constantly approached by men concerned about their penis size despite the fact that the majority are average with a flaccid length of to inches. However most men complaining of inadequate penile size do have associated sexual problems even if their penile dimensions fall within the normal range socalled dysmorphophobic penis said Gontero an associate professor of urology at the University of Turin. No study has however specifically addressed the extent and type of sexual bother in this patient category. Dysmorphophobia is a condition consisting of an imaginary flaw in the physical appearance the study noted. Writing in the April issue of the British Journal of Urology International Gontero and his colleagues found that penile extenders work better than techniques such as vacuum devices exercises and Botox injections and that psychological satisfaction is equally as important as any physical changes. A review of surgical techniques showed they increased phallus size an average of about a halfinch to inch but Gontero cautioned that the safest surgery which cuts the suspensory ligament of the penis to lengthen it often yields poor results. On the contrary more complex lengthening procedures are to be considered experimental and potentially dangerous he said. All procedures aimed to increase the penile girth should be considered unsafe leading to potentially poor cosmetic and functional results Gontero added. I have come across such cases that I had to reoperate in order to remove additive substances injected around the penis. The men studied ranged in age from to and were followed between three and months. More than of them used penile extenders with six experiencing minor problems such as bruising pain and itching. These devices yielded average flaccid length increases of between . inches and inch Gontero said and men achieving better results noted their satisfaction. Application of progressive and constant traction forces is a very oldfashioned technique used by the ancestors and currently by some tribal populations to elongate the penis or the neck he said. Gontero noted that cognitive behavioral therapy might help build confidence in some men. Longterm vacuum treatments did not appear effective producing no significant physical changes after six months Gontero said but did provide a degree of psychological satisfaction. He and his colleagues found no scientific evidence to support penilelengthening exercises. Dr. E. Douglas Whitehead director of New York Phalloplasty and associate clinical professor of urology at Albert Einstein College of Medicine in New York City said suspensory ligament surgery to increase penis length can be more effective when combined with stretching techniques. The human body even bone can be stretched he said. So stretching the penis when done long enough will work. If anything libido and desire are even better because you look better and feel better about yourself. More information For more about penis size visit Psychology Today http SOURCES Paolo Gontero M.D. associate professor urology University of Turin Italy Elizabeth Kavaler M.D. urologist Lenox Hill Hospital New York City E. Douglas Whitehead M.D. director New York Phalloplasty and associate clinical professor of urology Albert Einstein College of Medicine New York City April British Journal of Urology International"

"Its a portable piece of technology providing seemingly bottomless access to a drug craved by more than billion people worldwide nicotine. That craving is caused by smoking tobacco but is now being increasingly satisfied by ecigarettes and the trend to vape instead of smoke. The selling point is the clean image ecigarettes purvey by removing the simultaneous exposure to the tar and thousands of chemicals found in the tobacco smoke of regular cigarettes removing the cause of lung diseases as well as other tobaccorelated conditions. Tobacco kills almost million people each year according to the World Health Organization WHO and a growing number of people are now vaping instead of smoking resulting in industry worth . billion worldwide. Since their introduction in ecigarettes have become commonplace among smokers trying to kick their habit with a third of smokers trying to quit in the United Kingdom turning to ecigarettes to aid them according to one study httpsedition.cnn.comhealthecigarettessmokingaddictionnicotine But some critics argue these electronic nicotine delivery systems ENDS are fueling a new addiction to nicotine particularly among young people experimenting with them. Allure for adolescents While ENDS may have the potential to benefit established adult smokers ... they should not be used by youth and adult nontobacco users because of the harmful effects of nicotine and other risk exposures says Tim McAfee director the Office on Smoking and Health at the U.S. Centers for Disease Control and Prevention. Exposure to nicotine can harm adolescent brain development. Read Contact lens with builtin telescope httpedition.cnn.comtechcontactlenstelescopeblindnessindex.html Studies conducted by the CDC through its Adult and Youth National Tobacco Surveys found increased experimentation by youth trying out ecigarettes but not conventional cigarettes. The gadgetry and flavors associated with the devices is suggested as a reason behind this with fears of them acting as a gateway into real tobacco smoking. Benan BarwickCNN But others in the field of tobacco control disagree stating that whilst people including youth may have tried ecigarettes the evidence is lacking for their regular use. Kids like new technology and just experiment or use it once or twice says JeanFrancois Etter professor of Public Health at the University of Geneva. Etter has been researching the use of ecigarettes since and believes they are much safer than conventional cigarettes. The most dangerous way of consuming nicotine is to smoke it he says. Etter argued this point last week at the World Conference of Tobacco or Health http in Abu Dhabi. Whilst Etter says that use among young people should be monitored he believes the role of ecigarettes in reducing global tobacco consumption is more important. They are a gateway out of smoking says Etter. The number of people using a combination of tobacco and ecigarettes is on the rise according to Etter resulting in smokers switching and consuming less tobacco each day. They have the same level of nicotine but people are less exposed to toxins ... nicotine is not a health problem he says. However further evidence on the longterm health effects of ecigarettes or nicotine is needed. Satisfying the craving Nicotine is the main substance keeping people addicted to smoking tobacco and consequently exposing them to the tar and toxins found in cigarettes. Whilst many people try to kick the habit cold turkey nicotine replacement through gums and patches has long been advocated as a helping hand. Nicotine withdrawal is a very unpleasant process says Linda Bauld professor of Health Policy at the University of Stirling whose recent report https_datafileEcigarette_uptake_and_marketing.pdf for Public Health England identified an extensive and growing market for ecigarettes worldwide. The vast number of people using ecigarettes are using them to stop smoking theyre about more effective than going cold turkey or buying nicotine replacement therapy over the counter. Baulds research hasnt identified a dependence on nicotine with ecigarettes in the same way as the addiction resulting from regular cigarettes. Ecigarettes are not the best nicotine delivery devices she says referring to the fact nicotine is not seen to enter the bloodstream as readily when using ecigarettes. Thats backed up by Etters research http as well as a recent study httpnews.psu.edustoryresearchecigaretteslessaddictivecigarettesby researchers at Penn State College of Medicine in which ecigarettes were found to be less addictive than tobacco cigarettes. Benan BarwickCNN They do however provide nicotine more effectively than aids such as patches or gums according to Bauld. Patches and gums are a very small market says Etter about the quitting devices which first came onto the market years ago. He fears too much restriction on ecigarettes will limit their impact in achieving a world free of tobacco. Both Bauld and Etter recognize the need to monitor the consumption of nicotine among teenagers but feel the value of ecigarettes among adult smokers and their potential to save lives by reducing tobacco consumption should not be underestimated a sentiment recognized by the World Health Organization. Ecigarettes could be a way to help people quit but we need more evidence and regulation says Armand Peruga program manager for the WHOs Tobacco Free Initiative http which has celebrated years of its Framework for Tobacco Control http at the conference in Abu Dhabi. Legislate and regulate The greatest impact to date in reducing the number of smokers worldwide has been the taxation and legislation restricting tobacco advertising and increasing prices. For every increase in tax you have reduction in tobacco consumption says Peruga. The growing fear is the increasing domination of big tobacco in the ecigarette market which was once seen as a competitor. Their ownerships of popular ecigarette brands could push out smaller companies in the field reminiscent of the original tobacco epidemic. The intent of big tobacco is to sell their product concludes Peruga. They may expand their market to other customers who didnt use cigarettes but might consider nicotine use. But as it seems ecigarettes are here to stay most calls are for informed regulation rather than prohibition. The majority of ecigarettes especially when they are well regulated are likely to be less toxic than cigarettes and that for smokers is an advantage says Peruga."

"If the highpitched whir of a dentists drill as it bores into your molar terrifies you good news There could be fewer fillings in your future. A painless way to prevent cavities in adults is gaining traction. OK Alice we are going to put the fluoride varnish on your teeth says Marion Manski https director of the dental hygiene program at the University of Maryland School of Dentistry. Fluoride varnish is standard practice for childrens teeth but Manskis patient Alice Clash is years old. Like many older patients Clash is taking medications that cause dry mouth httpnidcr.nih.govoralhealthtopicsdrymouthdrymouth.htm which puts her at high risk for cavities. So Manski takes a skinny brush and a little pot of yellowish liquid and paints the varnish on Clashs teeth. We know that saliva helps us wash away bacteria and food in the mouth Manski says. The fluoride varnish will help that. One way fluoride helps is by seeping into the enamel and drawing the calcium and phosphate thats naturally present in the saliva. The minerals boost the teeths natural healing process and make them more resistant to future decay. But there are other theories about how fluoride works. It strengthens the enamel before the tooth erupts which is why its so important for children. And it attacks the acidproducing bacteria in the mouth. One study httppubs.acs.orgstokenpresspacpresspacabs.la shows fluoride makes it more difficult for these bacteria to stick to the teeth. Article continues after this message from our sponsor It takes about a minute and the fluoride treatment is done. Some patients are also given a prescription for a concentrated fluoride gel that can be used at night. These preventative approaches work on adults just as well as they do on children says Norman Tinanoff https a professor of pediatric dentistry at the University of Maryland. He says part of whats making fluoride treatments popular for adults is a move to make dental care personal with an individual treatment plan for each patient. To do that you have to weigh a patients risk of getting cavities. One of the biggest proponents of this approach is John Featherstone httpprofiles.ucsf.edujohn.featherstone dean of the University of California San Francisco School of Dentistry. Featherstone came up with a comprehensive way of measuring http a persons risk for caries http or tooth decay. It includes testing the level of bacteria in the mouth and looking at dietary habits medical conditions medications saliva flow and history of tooth decay. When Featherstone put his patients on personal treatment plans he found the strategy http worked. It really proved that drilling and filling did not fix the disease Featherstone says. Putting in a filling fixes that hole in the tooth but it doesnt deal with the bacteria in the rest of the mouth. Most bacteria are friendly but a couple of bad actors can cause cavities. These guys feed on sugars and expel acid that eats away at the enamel. Traditionally dentists were taught that the only way to deal with decay was to drill it out. Thats still important in some cases Featherstone says but without fixing the underlying problem of bad bacteria patients just keep coming back for more fillings. Featherstone saw another way. Its a little bit like your car is starting to rust he says. If you can stop the rust before the rust goes right through the body of the car then youre in good shape. Like rust tooth decay is a slow process. A fullon cavity is a hole that needs to be fixed. But if you catch decay early Featherstone says it can be reversed http fluoride treatments like varnish and concentrated toothpaste and gels. In the past we believed tooth decay was a rapidly progressive disease. But research shows its slowly progressive says Wendell Evans http_evans associate professor of dentistry at the University of Sydney in Australia. He recently published a study httponlinelibrary.wiley.comdoi.cdoe.epdf that found using these techniques reduced the need for fillings in adults by to percent. Striking as these results seem the concept isnt new. This shift to a preventive model of dentistry is decades in the making. Some of the stuff in our study has been known for years Evans says referring to the use of fluoride treatments. Prevention has always been a part of the world of dentistry says Richard Valachovic http_adeawho_we_areBiosRichard_W__Valachovic_D_M_D__M_P_H_.html president of the American Dental Education Association. What were seeing is a generational shift Valachovic says. As dentists have come to better understand the microbiology of the mouth more effective preventive techniques have followed. But cost has been an issue. Insurance companies routinely pay for fluoride treatments for children but not so much for adults. The National Association of Dental Plans http couldnt give a definitive answer about coverage but calls to some individual carriers and dental offices suggest it depends entirely on the type of plan you have. Some higherend plans cover two fluoride treatments per year while cheaper plans tend not to cover any. If you pay out of pocket a varnish treatment costs from to compared with a filling which ranges from to according to the American Dental Association http Cost could also be a factor for dentists. Featherstone and Wendell say some dentists may be reluctant to embrace the preventive methods because they worry theyll lose money if they they do fewer costly procedures. At this point Featherstone says twothirds of dental schools in the U.S. teach some kind of disease management model based on a thorough risk assessment. And he expects that at some point all dentists will follow a preventive protocol. It will happen Featherstone says. Its just a matter of time."

"Deep brain stimulation a technique used to treat Parkinsons disease and certain psychiatric disorders appears to provide some memoryenhancing benefits researchers report. Using electrical impulses to stimulate a part of the brain critical for memory function significantly improved patients navigational ability reflecting improved spatial memory the small study from the University of California Los Angeles UCLA suggests. Although the results are still preliminary the method may potentially hold promise for boosting memory in patients with early Alzheimers disease the researchers said. The thing to bear in mind is that its a first important step said Suzanne Haber a brain researcher and professor of pharmacology and physiology at University of Rochester Medical Center in New York who wasnt involved in the study. I think it was exciting that they were really able to show that stimulating that area was important for a certain kind of learning. It raises more questions and many more experiments that can be done. Seven patients awaiting possible surgery for the seizure disorder epilepsy had electrodes implanted in their brains to pinpoint the origin of their convulsions. The researchers followed them and found they were better able to recognize landmarks and to navigate routes more quickly in a video game featuring a taxi cab virtual passengers and a cyber city. Patients played the role of cab drivers who picked up passengers and delivered them to one of six requested shops in the city. Stimulation of the entorhinal cortex a region considered crucial to transforming daily experience into lasting memories produced the improvement the researchers said. The study is published Feb. in the New England Journal of Medicine. During the video game task participants learned their way around a virtual town with and without fivesecond periods of deep brain stimulation and were tested for their ability to reach predetermined landmarks. Six patients showed a percent reduction in excess path length the ideal path between destinations which indicated better performance for locations that had been learned during periods of deep brain stimulation. For five patients navigation to each of the three stores learned during stimulation was faster and shorter than navigation to the three stores learned without stimulation indicating a consistent effect the study said. Stimulating the hippocampus a brain region next to the entorhinal cortex which helps form and store memories produced no effect during this experiment however. Critically it was the stimulation at the gateway into the hippocampus and not the hippocampus itself that proved effective senior study author Dr. Itzhak Fried a professor of neurosurgery at the David Geffen School of Medicine at UCLA said in a university news release. Our preliminary results provide evidence supporting a possible mechanism for enhancing memory particularly as people age or suffer from early dementia. At the same time we studied a small sample of patients so our results should be interpreted with caution Fried added. Currently deep brain stimulation is used to control the tremors associated with Parkinsons symptoms of obsessivecompulsive disorder and some other psychiatric conditions including depression. Haber noted that the brain damage that occurs with epilepsy which can produce memory problems is different than that resulting from Alzheimers disease in which the formation of amyloid plaques and neurofibrillary tangles are believed to contribute to nerve cell deterioration. So its difficult to generalize this studys results to other diseases that affect memory she said and the research didnt show if effects of temporary deep brain stimulation last beyond the study period. In these types of studies you think of things like this Haber said but how real it is is something were going to have to see. I think just trying to work out that there is some similarity in very simple learning processes in the brain is important. More information To learn more about deep brain stimulation visit the American Association of Neurological Surgeons http SOURCES Suzanne Haber Ph.D. professor pharmacology and physiology University of Rochester Medical Center Rochester N.Y. Feb. New England Journal of Medicine"

"Nicotine replacement therapies such as gums or patches may not help smokers kick the habit longterm a new study shows. Relapse rates of the quitters were similar during the study period whether they used the products alone or with counseling or they did not use them. Nicotine replacement therapies ... do not show any longterm effect on quitting even when combined with counseling says researcher Gregory Connolly DMD director of the Center for Global Tobacco https Control and professor of public health at the Harvard School of Public Health. Behavioral counseling is widely recommended with medication https to help smokers quit. The results of the new study are published online in Tobacco Control. The findings are at odds with clinical trials https Connolly says. The new study however draws from the population. It gives a more real world picture he tells WebMD. Smoking cessation https experts and a maker of nicotine replacement therapies took issue with the findings. Connolly does not advocate abandoning the nicotine replacement medication. Instead he suggests understanding its use. In the short term what it is designed for is treatment of withdrawal he says. Long term our study would not say it would prevent relapse. Better strategies are needed to prevent relapse he tells WebMD. Nicotine Replacement Study Details Connolly followed adult smokers who had recently quit in Massachusetts. The participants were interviewed over three time periods In to to and to . Of the people finished the second interview and the third interview. The participants told whether they had used a patch gum inhaler or spray. They told how long they used the product continuously. The recommended practice is to use the product for eight weeks Connolly says. Most did not use the products. For instance at the first interview did not use them. Those who did use them did so for various time periods. At the first interview the of those who used the products did so for more than six weeks About onethird of the quitters had relapsed at each of the three time periods. The chances of relapse were not affected by use of the nicotine replacement products for more than six weeks or whether the program included counseling. The relapse odds were highest for those who had been heavily dependent on nicotine and used the products but did not get counseling. In the past five years the declines in adult smoking https seen in previous years have stalled Connolly says. Deciding how best to get smokers to quit for good is a public health challenge. Sales of the nicotine replacement products have risen Connolly says. Sales totaled million in when nicotine gum was introduced. Since sales have totaled more than million annually. The findings of this study cast doubt on the relative effectiveness of NRT nicotine replacement therapy as a population strategy the researchers write. The money now spent on coverage for the medications Connolly says should be balanced by ongoing public health programs that encourage smokers to quit. Professor We Shouldnt OverEmphasize Nicotine Replacement Therapy Steven Schroeder MD professor of medicine and director of the Smoking Cessation https Leadership Center at the University of California San Francisco reviewed the study findings for WebMD. Its a useful reminder that there are many ways to help smokers quit and we shouldnt overemphasize nicotine replacement therapy he tells WebMD. However he sees some limitations to the study. He questions whether more participants were needed to find the true effects of the medication with or without counseling. Another limitation he says is that few took the treatment as recommended. His bottom line I tell smokers its important to quit. Some do it cold turkey. But data show if you get counseling and one or more of the medications it will increase your chances of quitting longterm. He is referring to previous studies showing that the combination approach helps people quit. The study is seriously biased says Saul Shiffman PhD professor of psychology https at the University of Pittsburgh and a longtime researcher in the field. He serves as a consultant to GlaxoSmithKline which markets the nicotine replacement products Nicorette https and NicoDerm https CQ. He too cites the limited use of the products as a problem. He believes clinical trials such as those that compare using the medications to not using them give a truer picture. Numerous clinical trials he says show that these medications double your chances of quitting. Nicotine Replacement Industry WeighIn When it comes to smoking cessation https there is no magic pill says Deborah Bolding a spokesperson for GlaxoSmithKline in an emailed statement to WebMD. She cites hundreds of clinical trials showing the products work when used as directed. NRT products she writes have helped millions of smokers quit by gradually weaning them off their tobacco addiction https and the approach is recommended as a primary therapy for quitting."

"Sophisticated brain scans accurately predicted which teens with dyslexia would learn to read within three years a finding that could lead to better ways to treat the common learning disability researchers said on Monday. By looking for a specific pattern of brain activity in teens with dyslexia the researchers predicted with percent accuracy which students would learn to read. This gives us hope that we can identify which children might get better over time Dr. Fumiko Hoeft of Stanford University School of Medicine whose study appears in the Proceedings of the National Academy of Sciences said in a statement. More study is needed before the technique is clinically useful but this is a huge step forward. Dyslexia is a brainbased learning disability that affects to percent of U.S. children. People with dyslexia have difficulties with reading spelling writing and pronouncing words. About onefifth of people with severe dyslexia learn to read. Hoeft and colleagues wanted to see what was occurring in the brain in these students. They studied teens aged to who took a battery of tests to determine their reading abilities. Based on these they classified of them as dyslexics. The team used two different imaging techniques including functional magnetic resonance imaging which measures oxygen used by the brain during different activities and diffusion tensor magnetic resonance imaging or DTI which reveals connections between brain areas. The researchers then showed the teens different pairs of words and asked then to identify which ones rhymed even though they were spelled differently. They found that about half of the children who were dyslexic had extra activity in a part of the brain near the right temple known as the right inferior frontal gyrus. And some of the children with dyslexia had stronger connections in a network of brain fibers that links the front and the back of the brain. When they checked these same children two and a half years later they found children who had this unusual brain activity were more likely to have learned to read than other dyslexics. Paper and pencil tests typically used for these children however were unable to predict which students would succeed. The reason this is exciting is that until now there have been no known measures that predicted who will learn to compensate Hoeft said. Alan Guttmacher director the National Institute of Child Health and Human Development one of the National Institutes of Health said the finding gives insight into how certain people with dyslexia compensate for reading problems. Learning why other individuals have difficulty compensating may lead to new treatments to help them overcome reading disability Guttmacher whose agency funded the study said in a statement. The study is part of a new field called educational neuroscience that uses brain imaging studies to help improve learning problems in children and teens. Editing by Vicki Allen Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"The supplement Aged Garlic Extract can reverse the buildup of deadly plaque in arteries and help prevent the progression of heart disease according to a new study scheduled for publication in the Journal of Nutrition. The research conducted at LA BioMed found a reduction in the amount of lowattenuation plaque or soft plaque in the arteries of patients with metabolic syndrome who took Aged Garlic Extract. Metabolic syndrome is characterized by obesity hypertension and other cardiac risk factors. This study is another demonstration of the benefits of this supplement in reducing the accumulation of soft plaque and preventing the formation of new plaque in the arteries which can cause heart disease said Matthew J. Budoff MD an LA BioMed lead researcher. We have completed four randomized studies and they have led us to conclude that Aged Garlic Extract can help slow the progression of atherosclerosis and reverse the early stages of heart disease. The study involved patients aged to years who had been diagnosed with metabolic syndrome. All the participants underwent screening at the beginning of the study to measure the total coronary plaque volume as well as dense calcium noncalcified plaque and lowattenuation plaque. The screening was conducted using Cardiac Computed Tomography Angiography CCTA a noninvasive imaging technology that accurately measures calcium deposits and plaque buildup in the arteries. Following evaluation the participants were given either a placebo or a dose of milligrams of Aged Garlic Extract every day. A followup screening conducted a year after the initial screening found those who had taken Aged Garlic Extract had slowed total plaque accumulation by reduced soft plaque and demonstrated regression less plaque on followup for lowattenuation plaque. Other LA BioMed researchers who participated in the study were Suguru Matsumoto Rine Nakanishi Dong Li Anas Alani Panteha Rezaeian Jeby Abraham Michael A. Fahmy Christopher Dailing Ferdinand Flores and Sajad Hamal. Sach Prabhu from Mercy Medical Center in Merced CA Alexander Broersen from Leiden University Medical Center in the Netherlands and Pieter H. Kitslaar from Leiden University Medical Center and Medis Medical Imaging System both in the Netherlands also participated. Funding for the study was provided by Wakunaga of America Co. Ltd. the producer of Kyolic Aged Garlic Extract. Dr. Budoff also has received honoraria from Wakunaga. About LA BioMed Founded in LA BioMed is one of the countrys leading nonprofit independent biomedical research institutes. It has approximately principal researchers conducting studies into improved diagnostics and treatments for cancer inherited diseases infectious diseases illnesses caused by environmental factors and more. It also educates young scientists and provides community services including prenatal counseling and childhood nutrition programs. LA BioMed is academically affiliated with the David Geffen School of Medicine at UCLA and located on the campus of HarborUCLA Medical Center. For more information please visit http"

"More research is suggesting that heavy smokers may benefit from screening for lung cancer to detect tumors in their earliest stages. A new study finds that regular smokers who received threedimensional Xrays to look for the presence of early tumors had a significantly lower risk of dying over a year period. The results are in keeping with those of a much larger study published last month which showed that these D Xrays or CT scans reduced the death rate among current and former heavy smokers by percent compared with screening using regular chest Xrays. That previous finding was very good news in the field said Dr. Bruce Johnson of the Dana Farber Cancer Institute who treats lung cancer patients and reviewed the results for Reuters Health. This latest study published in the journal Lung Cancer looked at death rates in a different smaller population of heavy smokers and estimated that those who received up to two CT scans would have between a and percent lower risk of dying compared to those who went unscreened. The data are consistent with earlier studies but there are still many issues to resolve regarding lung cancer screening Johnson said. For one scientists havent yet worked out how often to screen people and when to start. It is not clear when or how guidelines for lung cancer screening could be drawn up and until they are insurers including government programs such as Medicare are unlikely to pay the average cost of a scan. Furthermore an April study showed that percent of a patients initial lung CT scans show suspicious lesions that turn out not to be cancer but lead to needless invasive followup procedures and radiation exposure as well as stress and anxiety for patients and their families. The high socalled false positive rate is an issue said Dr. James Hanley of McGill University who also reviewed the findings for Reuters Health but many mammograms also find lesions that turn out to be benign. And for lung cancer doctors know there is a high falsepositive rate and have a set protocol to follow in order to determine which lesions are dangerous added Johnson. Lung cancer kills . million people a year globally and it will kill people in the United States alone this year according to the American Cancer Society. Tobacco use accounts for some percent of lung cancer cases in the U.S. and one estimate puts a smokers lifetime absolute risk of developing lung cancer between percent and percent. Fiveyear survival rates for lung cancer are low. In recent years CT scans in particular have been promoted by some hospitals and advocacy groups for lung cancer screening even though studies had not yet shown definitively whether such screening saves lives. In Dr. Claudia Henschke currently based at Mount Sinai School of Medicine and Arizona State University caused a stir when she published a study concluding that percent of lungcancer deaths could be prevented through widespread use of spiral CT. Her ideas were controversial to start with especially when other researchers found her work had been paid for by a tobacco company. In the current study funded in part by manufacturers of CT scanners along with government and other sources Henschke and her colleagues compared outcomes for nearly smokers and former smokers who volunteered to undergo CT scans to outcomes in two sets of people with smoking histories who were not scanned. The three groups of people had some important differences such as in average age and how long and heavily they had smoked so the researchers had to use mathematical tools to try to eliminate the influence of those differences said Hanley. For instance to compare death rates the researchers tracked how many people died among those who were screened then pulled out all the people with similar underlying characteristics in the other two groups and looked at their death rates Hanley explained. A total of people died in the screened population the authors report but applying the death rate among people with the same underlying characteristics in one of the unscreened populations they estimated that the number of deaths would have been . This translates into a percent lower risk of dying among the screened population. Applying the same methods to the other unscreened population the authors estimated that screening was associated with a percent lower risk of dying. Overall research is suggesting that CT scans of people at risk of lung cancer might make a dent in cancer mortality and its possible that more frequent screening might make an even bigger dent Hanley noted. If screening is going to work youve got to keep at it. SOURCE link.reuters.comquvr httplink.reuters.comquvr Lung Cancer online December . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"As he drove on the New Jersey Turnpike Doug Hikades biggest concern was never the traffic or the tolls but the next rest stop. Id be frantic recalled the Mount Laurel resident . Like most men his age Hikade suffered from the squeeze of an enlarged prostate. Unable to completely empty his bladder he needed to go far more often sometimes half a dozen times a night. Not anymore. Hikade is among thousands who have had a quick office procedure in which a urologist inserts tiny sutures that pull aside the two halves of the enlarged gland almost like curtains on a stage allowing for improved urinary flow. It is total relief he said. The procedure called a prostatic urethral lift does not improve flow as much as surgery in which a physician cuts away some of the inside of the prostate to allow better flow. But the lift procedure and recovery are much quicker with no hospital stay and fewer complications. And patients who get the sutures can always come back for surgery later. Bruce Sloane Hikades urologist said he was doubtful of the sutures at first until he saw the research data and watched another physician demonstrate the technique. He now has implanted the UroLift sutures in several dozen patients and said he likes it because it does not involve destroying any tissue. If I can preserve a guy and keep him whole I like that said Sloane who practices in Center City. Another initial skeptic urologist Steven A. Kaplan of the Icahn School of Medicine at Mount Sinai now performs the procedure as well though he remains unsure how long the improvement will last. In May researchers http said that improvements in peak urinary flow have lasted so far for five years in a study funded by device maker NeoTract Inc. of Pleasanton Calif. But one in patients ended up needing surgery anyway. With the UroLift sutures quick recovery is among the biggest pluses said Kaplan director of the Mens Health Program at the Mount Sinai Health System in New York. They can go to work the next day he said. A common problem Benign prostatic hyperplasia benign meaning no cancer is present strikes up to half of men by age . By age close to percent have symptoms from an enlarged prostate said urologist Sloane. Insurers generally want medication to be tried first but the drugs do not always work and can cause dizziness or other side effects. Both concerns side effects and lack of effectiveness motivated Paul Diamantis to come to Sloanes office for the lift procedure in May. The Haddon Heights resident had no problems with daytime urination but had to get up to use the bathroom several times a night he said. He lay back in a reclining chair in Sloanes office and rolled to one side so Sloane could inject a numbing agent in his prostate going through the rectum. Then Diamantis rolled onto his back and Sloane injected another numbing agent into the urethra. The physician then told Diamantis he would insert a cystoscope into his penis through the urethra until it reached the inside of the prostate. The thin black tube would serve as a sheath for the device that delivered the sutures. Diamantis seemed a bit apprehensive pressing his lips together in response. Now I want you to relax Sloane said. Youll feel it a little bit but not much. In went the scope followed by the delivery device a long silvery rod with a trigger handle on one end. Click Sloane squeezed the trigger to secure the first suture which unfolded into a Tshape on one end hugging the outside of the prostate like a miniature version of those molly bolts that are driven through drywall. The doctor adjusted the device slightly then squeezed the trigger again cutting the other end of the suture to the right length and securing it inside the urethra. The scope was fitted with a small internal camera allowing Sloane to monitor his progress on the screen of a nearby laptop. Diamantis got four sutures two on each side of the walnutsized gland. Some patients get five or six. His entire office visit lasted about an hour but he was back on his feet in minutes. It wasnt bad at all Diamantis said. Taking action before bladder is shot The device got its start more than a decade ago in a biomedical business incubator in California. Three engineers Ted Lamson Joshua Makower and Joseph Catanese III spent months interviewing patients and physicians learning that many were dissatisfied with current treatments for enlarged prostates. They developed UroLift after experimenting in cadavers and founded NeoTract in . The first patients were treated in Australia by the end of . Initial clearance from the U.S. Food and Drug Administration did not come until but now more than half of the patients treated to date are in this country said chief executive officer Dave Amerson. Insurers generally reimburse about for the procedure. Medicare covers it though some private insurers do not. Lamson worked with heart valves for his doctorate in biomedical engineering at Pennsylvania State University a good preparation for his work today. Faulty valves can make the heart work too hard over the long term and the muscle becomes baggy and weak the condition known as heart failure. Ditto for the bladder if it has to strain to force urine through a channel that is surrounded by an enlarged prostate. The bladder has to work a lot harder Lamson said. It is getting worse and worse. Sloane agreed saying it was an argument for not waiting too long to take action. The bladder can regain contractility as long as its not too far gone the urologist said. Once the bladder is shot you cant bring it back. In the days following Diamantis procedure as with most patients he experienced more frequent urination not less as his bladder adjusted to the unrestricted flow. Sloane said a significant improvement after four weeks is common. Hikade who had his procedure in August was so happy that he talked a neighbor into getting it and that man has since recommended it to someone else. And those trips on the turnpike You dont worry about the next rest area Hikade said. Its peace of mind now."

"A new investigational delivery method for localized vaginal estrogen therapy that utilizes an applicator free softgel to alleviate moderatetosevere vaginal pain during intercourse dyspareunia a symptom of vulvar and vaginal atrophy VVA received high rates of patient satisfaction among postmenopausal women according to posttrial survey results published in the journal Menopause. These survey results show that something as simple as a change to a more elegant delivery system that is easier to use and not messy might empower more postmenopausal women to seek prescription treatment for VVA and perhaps help them stay with the application guidelines for longer said study first author Sheryl Kingsberg PhD Division Chief OBGYN Behavioral Medicine UH Cleveland Medical Center Professor of Obstetrics and Gynecology and Psychiatry Case Western Reserve University School of Medicine and first author of the survey analysis. We still have to find better ways to educate the millions of women suffering with VVA about the symptoms however so that more of them know it is common decide to discuss treatment with their healthcare professional and seek symptom relief with appropriate treatment. The new results were part of a multicenter randomized placebocontrolled phase clinical trial for TXHR an investigational bioidentical estradiol applicator free vaginal softgel capsule. Previous publications have shown TXHR to be safe and effective at alleviating symptoms of VVA. The survey which included respondents with a percent response rate sought to quantify participants satisfaction with the application method and overall treatment delivery system. The majority of women taking either TXHR or placebo . . percent found the product easy to use. VVA is a chronic condition associated with genitourinary syndrome of menopause GSM. VVA affects to percent of postmenopausal women and is characterized by pain with sexual activity dryness and discomfort. Current onthemarket treatments for VVA include both overthecounter creams and moisturizers as well as several safe and effective prescription treatments in cream tablet ring or oral form. Previous survey research completed by Dr. Kingsberg and others has shown that while million women may be experiencing symptomatic VVA and suffering from related impacts on sexual function interpersonal relationships selfesteem and overall quality of life only percent are currently using a prescription therapy to alleviate symptoms. Though they may suffer from physical and emotional pain as a result of VVA women may not feel comfortable discussing these symptoms with a healthcare professional may not recognize the symptoms as treatable may not fully understand the treatment options available or if they did receive treatment found the current prescription treatment options inconvenient messy or uncomfortable to use. Financial disclosure Dr. Kingsberg has served as a consultant for TherapeuticsMD the manufacturer of TXHR as well as Acerus Pharmaceuticals AMAG Pharmaceuticals Bayer Healthcare Emotional Brain Materna Novo Nordisk Nuelle Palatin Technologies Pfizer Sermonix Pharmaceuticals Shionogi Inc. and Valeant Pharmaceuticals. About University Hospitals Founded in University Hospitals serves the needs of over million patients per year through an integrated network of hospitals more than outpatient health centers and physician offices in counties throughout northern Ohio. The systems flagship academic medical center University Hospitals Cleveland Medical Center located on a acre campus in Clevelands University Circle is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies Childrens Hospital ranked among the top childrens hospitals in the nation University Hospitals MacDonald Womens Hospital Ohios only hospital for women and University Hospitals Seidman Cancer Center part of the NCIdesignated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation including cancer pediatrics womens health orthopedics radiology neuroscience cardiology and cardiovascular surgery digestive health dermatology transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys including Americas Best Hospitals from U.S. News World Report. UH is also home to Harrington Discovery Institute at University Hospitals part of The Harrington Project for Discovery Development. UH is the second largest employer in northern Ohio with employees. For more information go to UHhospitals.org."

"Women who take hormone replacement therapy HRT to ease menopause symptoms like hot flashes and night sweats may be no more likely to die prematurely than women who dont take hormones a new study suggests. Many women have been reluctant to use hormones for menopause symptoms since when the federally funded Womens Health Initiative WHI study linked the treatments containing manmade versions of the female hormones estrogen and progestin to an increased risk of breast cancer heart attacks and strokes. The current study however looked at longerterm data from the WHI study and found no increased risk of death from all causes or from cancer or cardiovascular issues in particular associated with hormone use. Women seeking treatment for distressing hot flashes night sweats or other menopausal symptoms may find the mortality results reassuring said lead study author Dr. JoAnn Manson of Brigham and Womens Hospital and Harvard Medical School in Boston. Women go through menopause when they stop menstruating typically between ages and . As the ovaries curb production of the hormones estrogen and progesterone in the years leading up to menopause and afterward women can experience symptoms ranging from irregular periods and vaginal dryness to mood swings and insomnia. For the study researchers looked at data on women ages to who joined two WHI trials between and and were followed through . One trial tested estrogen alone against a placebo or dummy pill while the other trial tested estrogen taken in combination with progestin. Women were years old on average when they joined the trials and had already gone through menopause. They took hormones or a placebo for five to seven years and were followed for a total of years altogether. During the study period women died. Death rates were similar at about percent among women who took hormones and women who didnt researchers report in JAMA. Younger women in the study appeared to have better survival odds with HRT. Over the initial five to seven years when women were randomly assigned to take hormones or a placebo death rates were about percent lower among women aged to when they took HRT than when they didnt. For women who started hormones in their s or s however there wasnt a meaningful difference in death rates according to whether they got the treatment or a placebo during the initial years of the study. After years including both the treatment period and a decade or more of followup womens age when they joined the study no longer appeared to significantly influence death rates. One limitation of the study is that the WHI didnt look at different dosages of hormone pills and the findings may be different for other dosages or different types of therapy such as gels or creams or skin patches. Still the current study should ease concerns raised by earlier results from the WHI trials that an increased risk of breast cancer or heart attacks might translate into higher longterm mortality rates said Dr. Melissa McNeil author of an accompanying editorial and a womens health researcher at the University of Pittsburgh. Taking a combination of estrogen and progestin is associated with an increased risk of breast cancer but advances in screening and treatment since the WHI started now mean these tumors are unlikely to be fatal McNeil said by email. With additional years of followup it also appears that the increased heart attack risk associated with HRT in the initial results from the WHI trials is limited to older women McNeil added. Hormone therapy has been in and out of favor first it was good for all menopausal women then it was dangerous for all women McNeil said. The takehome message now is that for the right patient hormone therapy is safe and effective. SOURCE bit.lyjkqUFE httpbit.lyjkqUFE and bit.lyjopiX httpbit.lyjopiX JAMA online September . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Doctors are experimenting with new technology that could give them a more complete view of the large intestine than ever before improving the odds of finding potentially cancerous growths earlier. Dr. Arie Kaufman of SUNY Stony Brook demonstrated the virtual colonoscopy for CBS New Yorks Dr. Max Gomez. Well have both the computer and the doctors working in tandem to find polyps and find cancers Kaufman said. He added it could lead to better and earlier detection of colon polyps. Virtual colonoscopy screening uses CT scans to create color D images of the colon the final portion of the large intestine. Special computer animation enables a doctor to view the organ in remarkable detail. Regular colonoscopy physically examines the colon by inserting a lighted probe into the intestine and requires a sedative. Both have made early detection and treatment https more precise. This next step in virtual colonoscopy called immersive colonoscopy projects D images of the colon large enough to fill the walls of a room. Doctors can then walk through the colon and explore many different angles. We have the side view and the back view said Kaufman. This will allow the physician to view percent of the surface including lesions which are hidden behind folds maybe seen on the side and back walls. Such highly specific screening may allow doctors to detect more abnormal growths https called polyps when they are as small as . mm so they can be removed before they become fullblown cancer tumors. For the patient a virtual colonoscopy https is low risk but does involve additional exposure to radiation. It may need to be followed with the physical colonoscopy later as well. Colonoscopies are recommended for adults age and over to help detect early signs of colorectal cancer. Colorectal cancer is the second leading cause of death among the combined group of men and women who have cancer according to the National Institutes of Health http The CDC http says colonoscopy may also be recommended for people experiencing stomach pain aches or cramps that dont go away unexplained weight loss and blood in the stool. More routine DNA tests https and stool sampling https which show signs of bleeding caused by irregular growths can also help detect colon polyps and indicate that the need for a full colonoscopy. The CDC says colonoscopy could reduce the number https of colorectal cancer cases by as much as percent. This new wave of radiologybased colonoscopy could improve those odds further."

"Braeburn Pharmaceuticals and Camurus today announce top line results of a multipledose pivotal Phase study assessing the blockade by CAM of subjective opioid effects of multiple randomized hydromorphone challenges in adults with opioid use disorder. A key objective of medicationassisted treatment for opioid use disorder is to reduce or eliminate the use of illicit opioids. The results from the present Phase study demonstrate that CAM blocks effectively the subjective effects of opioid challenges with hydromorphone including limiting drug liking. This study provides clinical proof of concept that CAM will be an effective treatment for opioid use disorder said Behshad Sheldon President and CEO of Braeburn Pharmaceuticals The current opioid crisis demands innovation and CAMs novel technology is now one step closer to providing physicians and patients with a different approach to treating this deadly chronic disease. The primary endpoint was met for both CAM doses demonstrating blockade of the subjective effects of hydromorphone as measured by the Drug Liking Visual Analog Scale. Furthermore CAM was well tolerated across the course of treatment. The study results show that CAM provides rapid and extended blockade of opioid effects said Fredrik Tiberg President and CEO of Camurus. The results also confirm the dose selection in the current Phase program and the potential of CAM as a future treatment alternative for patients with opioid use disorder from initiation to longterm maintenance. The current study demonstrated that weekly injections of CAM produced significant and robust opioid blockade a critical mechanism of efficacy for medications treating opioid dependence. CAM has the potential to alter the current treatment paradigm for opioid dependence said Sharon Walsh Ph.D Professor of Behavioral Science and Director of the Center on Drug and Alcohol Research University of Kentucky Because of its long acting properties CAM may decrease patient and physician burden improve access to treatment and obviate public health concerns about illicit diversion of buprenorphine. We were pleased to be involved in the development of CAM and are hopeful that it will serve as another safe and effective therapeutic option for patients with opioid use disorder. The ability of CAM to produce a longlasting and robust blockade of hydromorphoneinduced Drug Liking is especially encouraging said Sandra D. Comer Ph.D Professor of Neurobiology Columbia University. Importantly the fact that CAM will be given in the clinic by health providers should address concerns about diversion of buprenorphine for illicit use. We feel that this medication with its ease of administration and flexible dosing capabilities could significantly improve management of patients. About the Phase Trial The Phase study was a threecenter randomized doubleblind inpatient study to evaluate the degree of subjective opioid blocking efficacy of CAM qw in nontreatmentseeking participants with moderatetosevere opioid use disorder. After screening participants were randomized to different CAM qw onceweekly injections for two weeks. During this period four challenge sessions were conducted with a randomized hydromorphone dose to determine subjective liking score based on a visual analogue scale. Additional information on the design of the trial can be found at http . About CAM The investigational CAM buprenorphine subcutaneous injection products for treatment of opioid use disorder are being developed as onceweekly and oncemonthly formulations each with multiple doses to cover all phases of treatment from initiation through maintenance. The CAM products are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion abuse misuse and accidental exposure. The CAM products have been evaluated in three Phase clinical trials which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of individuals opioiddependent patients and healthy volunteers under naltrexone blockage. Four more trials including two Phase studies are currently ongoing. CAM is also being developed for treatment of chronic pain. About Braeburn Pharmaceuticals Braeburn Pharmaceuticals an Apple Tree Partners company is a pillfree pharmaceutical company delivering precision medicine in neuroscience. In September the Food and Drug Administration FDA accepted for review Braeburns New Drug Application for its lead candidate Probuphine a sixmonth buprenorphine implant for treatment of opioid addiction. The Agency set May as the target date for action. Longacting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions which are often complicated by stigma and present significant public health challenges. Braeburns investigational product pipeline consists of longacting implantable and injectable therapies for serious neurological and psychiatric disorders including opioid addiction pain and schizophrenia. Candidates include Probuphine a sixmonth buprenorphine implant for treatment of opioid addiction CAM weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain a risperidone sixmonth implant for treatment of schizophrenia and a novel molecule ATI for treatment of schizophrenia. More information on Braeburn can be found at http About Camurus Camurus is a Swedish researchbased pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with bestinclass potential are conceived based on the proprietary FluidCrystal drug delivery technologies and an extensive RD expertise. Camurus clinical pipeline includes products for treatment of cancer endocrine diseases pain and addiction developed inhouse and in collaboration with international pharmaceutical companies. The companys share is listed on Nasdaq Stockholm under the ticker CAMX. For more information visit http Media contacts Fredrik Tiberg President CEO Tel fredrik.tibergcamurus.com mailtofredrik.tibergcamurus.com http Sherry Feldberg MSLGROUP Boston braeburnpharmamslgroup.com mailtobraeburnpharmamslgroup.com Logo httpphotos.prnewswire.comprnhLOGO Logo httpphotos.prnewswire.comprnhLOGO SOURCE Braeburn Pharmaceuticals Camurus Related Links http"

"Bottom Line For adults coming to the emergency department for arm or leg pain due to sprain strain or fracture there was no difference in pain reduction after hours with ibuprofenacetaminophen vs three comparison opioidacetaminophen paracetamol combinations. Why The Research Is Interesting The United States is facing an opioid epidemic with almost individuals dying from opioid overdoses since . Despite the epidemic opioid analgesics remain a firstline treatment for moderate to severe acute pain in the emergency department. The combination of ibuprofen and acetaminophen may represent an effective nonopioid alternative. Who patients ages to years with moderate to severe acute extremity pain in two urban emergency departments were randomly assigned to receive mg ibuprofen and mg acetaminophen mg oxycodone and mg acetaminophen mg hydrocodone and mg acetaminophen or mg codeine and mg acetaminophen When July to August What Study Measures The betweengroup difference in decline in pain two hours after taking the study drugs. How Study Design This was a randomized clinical trial RCT. Randomized trials allow for the strongest inferences to be made about the true effect of an intervention such as a medication or a procedure. However not all RCT results can be replicated because patient characteristics or other variables in realworld settings may differ from those that were studied in the RCT. Authors Andrew K. Chang M.D. M.S. of Albany Medical College Albany New York and coauthors Results After hours pain was less in all participants without any important difference in effect between the four groups. Study Limitations The results apply only to pain after two hours. About in patients required additional medication to control their pain. Study Conclusions There were no important differences in pain reduction after hours with ibuprofenacetaminophen or opioidacetaminophen combination pills in emergency department patients with acute extremity pain. The findings suggest that ibuprofenacetaminophen is a reasonable alternative to opioid management of acute extremity pain due to sprain strain or fracture but further research to assess longerterm effect adverse events and dosing is warranted. Related material The following related elements also are available on the For The Media website The editorial Opioid vs Nonopioid Acute Pain Management in the Emergency Department by Demetrios N. Kyriacou M.D. Ph.D. Senior Editor JAMA Chicago Northwestern University Feinberg School of Medicine Chicago. For more details and to read the full study please visit the For The Media website. doi.jama.. Editors Note Please see the article for additional information including other authors author contributions and affiliations financial disclosures funding and support etc. Want to embed a link to this study in your story Link will be live at the embargo time httpjamanetwork.comjournalsjamafullarticle.jama.."

"New data from centers that aggressively treat shortterm ministrokes offer new evidence that quick action can cut the odds of a serious stroke in half. The findings reported in the New England Journal of Medicine are more evidence of the benefits of sending someone to a hospital even if muscle weakness or slurred speech has only lasted for a few seconds lead author Dr. Pierre Amarenco of Bichat Hospital in Paris told Reuters Health by phone. Thats because ministrokes also known as transient ischemic attacks or TIAs are often the harbinger of a potentiallydeadly stroke that can come within a matter of hours or days. You should worry about symptoms even if they last for just a few seconds or a few minutes Amarenco said. The study showed that the widespread systematic implementation of specialized TIA units across multiple sites countries and continents can make a difference in the care of these patients write Drs. Ralph Sacco and Tatjana Rundek of the University of Miami in an accompanying editorial. The ongoing study which used previous stroke estimates for comparison was based on data from patients from TIAregistry.org an international registry designed to follow cases for as long as five years. It didnt include a comparison group which would offer the best evidence but it helps build the evidence base for the importance of getting in for early treatment said Dr. Donna Arnett dean of public health at the University of Kentucky and past president of the American Heart Association. Any kind of ministroke should lead you to be evaluated said Arnett who was not involved in the study. Research reported prior to had suggested that the stroke risk is percent two days after ministroke symptoms appear and between percent and percent for the to day period after symptom onset. But in the new study Amarenco and his colleagues found stroke risks of . percent at two days . percent at seven days and . percent at days when ministrokes were treated aggressively. One year after symptoms the stroke rate was . percent. Although this was not a randomized trial and there was no comparison group to assess whether specialized units performed better than nonspecialized stroke units these newlyreported risks are substantially lower than expected. Outcomes in this study were at least percent lower than those reported in previous studies Sacco and Rundek write. The rate was remarkably lower Arnett told Reuters Health. The study was also noteworthy because over the long haul patients did a particularly good job of taking the medications they were given. The researchers also found that the oneyear stroke risk doubled when multiple blood vessel clogs were seen with brain imaging a large artery was narrowed by heart disease and the patient scored a or on a sevenpoint scale that assesses stroke risk factors. More than two thirds of the patients in the study had a score of or higher but the researchers caution that limiting urgent assessment to patients with a score of or more would miss approximately percent of those with early recurrent strokes. SOURCE bit.lyMGDlo httpbit.lyMGDlo New England Journal of Medicine online April . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Botox injections may provide some relief from arm tremors caused by multiple sclerosis according to a small study published Monday. Botulinum toxin type A is sold under different brands but its best known by the Allergan brandname Botox. A sample of Botox is seen at the Long Island Plastic Surgical Group at the Americana Manhasset luxury shopping destination in Manhasset New York September . REUTERSShannon Stapleton Botox gained fame for smoothing aging skin by blocking nerve signals and relaxing muscles under the skin but the product has a number of medical uses. In the U.S. Botox is approved to treat conditions like chronic migraine excessive sweating and certain symptoms of MS overactive bladder and muscles spasms in the arms. The new study published in the journal Neurology tested the effects of Botox injections on MSrelated arm tremors which affect up to twothirds of people with MS. Researchers found that when they gave injections to patients the treatment typically eased their tremors and improved their writing ability. Right now theres no good way to treat MS arm tremors said Nicholas G. LaRocca vicepresident of healthcare delivery and policy research at the National MS Society. Physical therapy and exercise have been studied but are usually not very effective said LaRocca who was not involved in the new study. Surgery is sometimes used in severe cases but its risky and may not even have lasting benefits. Exploring new treatments is important and its heartening to see theres some promise here LaRocca said of the current findings. But theres still a lot to be learned he cautioned in an interview. This study is fairly preliminary and it had a small number of patients LaRocca said. Larger studies of morediverse groups of MS patients are needed he said. The studys lead researcher agreed on the need for more work. There are several questions that need to be answered by doing larger and longerterm studies Dr. Anneke van der Walt a neurologist at Royal Melbourne Hospital in Australia said in an email. One is how long the benefits of repeat Botox injections might last this study tested the effects of just one Botox treatment over three months. In real life the injections would have to be repeated every few months or possibly every six months for some people according to van der Walt. Another question is whether the side effects change over time. Muscle weakness was the most common side effect in this study van der Walt said. It affected percent of the study patients though it went away within two weeks. Muscle weakness is a potential concern in MS patients LaRocca noted since that problem often comes with the disease itself. The study included MS patients with mild to moderate arm tremors. Each patient received a round of Botox injections and a round of placebo injections containing saline three months apart. Half of the patients got the Botox first the other half the placebo. On average the patients tremor scores had gone from a to a six weeks after Botox treatment which essentially means moving from moderate to mild LaRocca said. Their ability to write and draw a straight line had also improved by week six and the benefits were still there at week . In contrast there were no improvements after the placebo injections. Larger studies van der Walt said should look at whether Botox is more effective for some tremors than others. Tremors limited to the hand and forearm for instance might respond better than tremors that also affect the shoulder. If Botox is eventually approved for this MS symptom LaRocca said it will be important for doctors to get training in how to give the injections since the drug has to go into carefully chosen locations in the muscle. So practitioners will have to be up to speed LaRocca said. There will also be the matter of cost. That will vary from patient to patient depending on how many injections are needed per treatment. According to van der Walt the cost could range from to Australian dollars which are roughly equal to U.S. dollars. In the U.S. Botox treatments can cost per injection site. Botox maker Allergan supplied the product for the study and two of the researchers on the work have financial ties to the company. The study itself was funded by the Box Hill MS Research Fund and the Royal Melbourne Hospital. SOURCE bit.lylUcacJ httpbit.lylUcacJ Neurology online July . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"A minimally invasive treatment can help restore fertility in women with uterine fibroids according to a new study published online in the journal Radiology. Uterine fibroids abnormal masses of fiber and muscle tissue in the wall of the uterus are considered one of the most common causes of infertility and complications related to pregnancy. Previous research has found that one out of every four women with fibroids has problems related to fertility. The standard treatment option for such women is myomectomy or surgical removal of the fibroids. However myomectomy is not always possible or effective and can result in major complications including hysterectomy according to study coauthor Joo Martins Pisco M.D. Ph.D. from the Department of Interventional Radiology at Saint Louis Hospital in Lisbon Portugal. Uterine fibroid embolization UFE is a less invasive option that involves injection of an embolic agent typically made up of very small beads into the uterine arteries to block the blood supply to the uterus and fibroids. As the fibroids die and begin to shrink the uterus fully recovers. UFE can be performed in patients with a prior myomectomy or in vitro fertilization IVF. Despite its less invasive nature UFE has yet to be fully embraced in the medical community as a fertilitypreserving treatment for women with symptomatic fibroids due to concerns that the procedure may cause inadequate blood flow to the endometrium or lining of the uterus and the ovaries. For the new study Dr. Pisco and colleagues assessed pregnancy rates in women with uterine fibroids who were unable to conceive and who underwent either conventional or partial UFE. In conventional UFE all uterine artery branches are embolized. However the partial procedure requires treatment of only the small vessels to the fibroids leaving the corresponding larger vessels unaffected. Partial UFE may help reduce the risks of infertility associated with conventional UFE. After an average followup of almost six years of the women or . percent had become pregnant one or more times and gave birth to a total of babies. It was the first pregnancy for more than percent of the women who gave birth. The procedures had a clinical success rate of approximately percent for fibroidrelated symptoms. Complication rates were . percent for partial UFE and . percent for conventional UFE. The procedure was repeated in patients whose fibroids had not been fully treated as shown by MRI and of those patients subsequently got pregnant. Our findings show that UFE is a fertilityrestoring procedure in women with uterine fibroids who wish to conceive and pregnancy following UFE appears to be safe with low morbidity Dr. Pisco said. Women who had been unable to conceive had normal pregnancies after UFE and similar complication rates as the general population in spite of being in a highrisk group. Dr. Pisco suggested that UFE may become the firstline treatment for women with fibroids who wish to conceive particularly for those with numerous or very large fibroids. Such patients have a fibroid recurrence rate of more than percent after myomectomy making UFE an important option. The researchers are continuing the treatments and compiling data. Since the time of writing there were additional pregnancies. In our study there are now almost newborns following UFE Dr. Pisco said. Our next step will be a randomized study comparing the results of partial and conventional UFE. Spontaneous Pregnancy with a Live Birth after Conventional and Partial Uterine Fibroid Embolization. Collaborating with Dr. Pisco were Marisa Duarte M.D. Tiago Bilhim M.D. Ph.D. Jorge Branco M.D. Ph.D. Fernando Cirurgio M.D. Marcela Forjaz M.D. Lcia Fernandes M.D. Jos Pereira M.D. Nuno Costa M.D. Joana B. M. Pisco M.D. and Antnio G. Oliveira M.D. Ph.D. Radiology is edited by Herbert Y. Kressel M.D. Harvard Medical School Boston Mass. and owned and published by the Radiological Society of North America Inc. httppubs.rsna.orgjournalradiology RSNA is an association of over radiologists radiation oncologists medical physicists and related scientists promoting excellence in patient care and health care delivery through education research and technologic innovation. The Society is based in Oak Brook Ill. RSNA.org httpRSNA.org For patientfriendly information on uterine fibroid embolization visit RadiologyInfo.org httpRadiologyInfo.org."

"Women who have had breast cancer should consider annual screening with breast MRI in addition to an annual mammogram new research indicates. Currently the American Cancer Society recommends annual breast MRI plus mammography for women at very high risk for breast cancer such as those with a known genetic mutation known as BRCA or those with a very strong family history. But it takes no position on MRI imaging for women who have had breast cancer saying there is not enough evidence to recommend one way or the other. Studying the effectiveness of MRI screening on all three groups of women Dr. Wendy DeMartini an assistant professor of radiology at the University of Washington Medical School said MRI imaging found proportionally more cancers in women who had been treated for breast cancer than in the women considered at very high risk. Women in the personal history group who had MRI were also less likely to be recalled for additional testing and less likely to have a biopsy for a false positive finding she said. DeMartini was scheduled to present the findings Sunday at the annual meeting of the Radiological Society of North America in Chicago. For the study her team reviewed initial breast MRI exams of women conducted from January to June . Of these had a genetic or family history had a personal history of breast cancer that had been treated. Overall the MRI detected of cancers DeMartini said. With the MRI screen we found cancer in just over percent of women with a personal history which was double that found in those with a genetic or family history she said. However still more research is needed to clarify the role of MRI in this population she said. The findings are impressive said Dr. Robert Smith director of cancer screening for the American Cancer Society. While the society recommends neither for nor against MRI imaging for those with a personal history of breast cancer he said it regularly reviews study findings to determine if the guidelines need updating. There are some tumors that dont show up on mammography as well as they do on MRI he explained. MRI highlights angiogenesis the formation of new blood vessels especially those that feed cancerous tissues. Until more research is in what should a woman with a personal history of breast cancer do She should talk to her doctor Smith said. He doesnt see a downside to getting an MRI except perhaps an increased risk of false positives and perhaps a need to pay out of pocket. More information To learn more about breast cancer screening visit the American Cancer Society http SOURCES Wendy DeMartini M.D. assistant professor breast imaging University of Washington and Seattle Cancer Care Alliance Seattle Robert Smith M.D. American Cancer Society Atlanta Ga. Nov. presentation Radiological Society of North America annual meeting Nov. Chicago"

"If you drink more alcohol than you want to or should youre not alone. A nationwide survey httpspubs.niaaa.nih.govpublicationsRethinkingDrinkingRethinking_Drinking.pdf by the National Institutes of Health found that percent of adults in the U.S. are heavy drinkers or drink more than is recommended. Yet most heavy drinkers dont get the help they need. The biggest problem we have in the field is that less than percent of individuals with an alcohol use disorder get any treatment whatsoever says George Koob https director of the National Institute on Alcohol Abuse and Alcoholism. Part of the challenge researchers say is that many drinkers dont realize that a medicine long used to help people addicted to opioids quit their drug habit can help alcoholics and other heavy drinkers cut back too. I thought my only option was AA John tells NPR. Weve agreed to use only his middle name disclosing his trouble with alcohol publicly he says would jeopardize his business. Hes a yearold professional who says he started out as a social drinker a few beers with his softball team after a game. But he sank into a deep depression after several deaths in his family and sought solace in the bottle he says. I wanted to numb my thoughts says John. Hed often start with hard liquor in the morning John says and it wasnt uncommon to have eight drinks or more before the end of the day. He worked from home so he was able to mask the problem for a while. But eventually his wife confronted him. Article continues after this message from our sponsor She had come home and I was rushing to hide a glass and she was furious with me he recalls. Just absolutely furious. He went to see Paula DeSanto httpmnalternatives.comaboutus.html a therapist and director of Minnesota Alternatives in Spring Lake Park Minn. The center provides outpatient mental health and substance use treatment services. I would say Johns story is not unique DeSanto tells us. A lot of people are reluctant. Sometimes traditional treatments such as residential rehab or a step program like Alcoholics Anonymous can lead to a significant disruption in their lives she explains. Theres stigma shame and embarrassment. DeSanto suggested a different approach to John. To help work through the loss and grief he was feeling counseling can help she told him. She also recommended he try naltrexone https a prescription drug. Naltrexone is an effective medication for the treatment of alcohol use disorders says Koob. He points to a recent metaanalysis published https in the journal Addiction that concluded that naltrexone helped reduce heavy drinking and cravings for alcohol. The analysis included data from clinical trials in which people were given either the medication or a placebo pill to test the effectiveness of the treatment. The analysis also found that another drug acamprosate https is effective at helping people who have already stopped drinking to maintain abstinence perhaps partly by easing the physical and emotional cravings experienced by heavy drinkers who quit. So how does naltrexone work The drug seems to curb the euphoric and sedative effects of opiates in the brain. Alcohol is known to activate some of the same receptors in the brain that opioids do and studies find that by tempering the pleasure https from alcohol naltrexone can help people drink less. It blunts the effects of alcohol says Koob. People who use naltrexone will say they have a drink and its not doing much for them. That was exactly Johns experience. After taking the naltrexone pill he didnt get the buzz he was used to getting so didnt want to keep drinking. I actually didnt feel the alcohols effects he says. It was startling. Its now been about five months since he started taking the medication. He has not stopped drinking completely but says he has cut way back. This is helping me John says. I can go out with friends and not worry that Im going to end up inebriated or sloppy. According to the findings https of a recent review both naltrexone and acamprosate are safe costeffective and efficacious. But they are substantially underused according to the review. Many physicians are unaware that there are medications to treat alcohol use disorders says Koob. His institute is stepping up efforts to work with the medical community on that front he says and is also touting Rethinking Drinking https a website aimed at consumers that offers the latest researchbased information on a range of treatment options. Any health care provider who is licensed to prescribe medicine can prescribe naltrexone not just mental health professionals or addiction specialists. As as long ago as a published study showed https treatment of alcohol dependence with naltrexone by primary care doctors can be effective followup research has confirmed that the primary care approach not only works but makes treatment much more accessible. According httpspubs.niaaa.nih.govpublicationsRethinkingDrinkingRethinking_Drinking.pdf to the NIAAA patients can now receive effective alcohol treatment from their primary care doctors or mental health practitioners by combining the newer medications with a series of brief office visits for support. Naltrexone is certainly not a cureall researchers say. And it wont help everyone who has a drinking problem especially if the disorder is severe. I use these medications as an adjunct to therapy and group sessions and step meetings says Dr. Jeffrey Hsu http a psychiatrist at Johns Hopkins University who is certified in addiction medicine. He says that when used alone the medicines are only modestly effective. But theres good evidence that the combination of counseling and drugs such as naltrexone can help people cut back on drinking or move toward abstinence."

"Patients with obesity who swallowed gasfilled balloon capsules designed to help them eat less lost . times more weight than patients who relied on diet exercise and lifestyle therapy alone according to new research presented today at ObesityWeek httpobesityweek.com the largest international event focused on the basic science clinical application and prevention and treatment of obesity. The annual conference is hosted by the American Society for Metabolic and Bariatric Surgery ASMBS httpasmbs.org and The Obesity Society TOS http The significant weight loss achieved with the Obalon Month Balloon System is maintained at months said Aurora Pryor MD study coauthor and Chief Bariatric Foregut and Advanced GI Surgery Stony Brook University. This combination of lifestyle modification and balloon therapy provides a new low risk option for patients struggling with obesity. The Obalon Month Balloon System a swallowable gasfilled intragastric balloon for weight loss in adults with obesity for whom diet and exercise has failed was approved in September by the U.S. Food and Drug Administration FDA. It involves a balloon contained within a capsule that once it reaches the stomach is inflated with gas via a microcatheter. Up to three balloons may be placed over the first three months but the entire treatment period lasts six months. The inflated balloons make patients feel full. Treatment is accompanied by a moderate intensity diet and behavior modification program. The device is manufactured by Obalon Therapeutics Inc. based in San Diego CA. Results of the study were based on a doubleblinded randomized shamcontrolled trial of patients about half of whom received treatment with the Obalon balloon and the other half with a sugarfilled sham capsule designed to look like the device. Patients who had a body mass index BMI of between and swallowed three capsules over a week period one every three weeks. All patients at the study sites also underwent minutes of lifestyle therapy administered by a blinded registered dietitian every three weeks. After six months patients were informed which capsule they received and those with the Obalon balloons had them removed endoscopically. Average percent total weight loss after six months for Obalon balloon patients was . percent while those in the sham control group had . percent total average weight loss. Balloontreated patients had nearly percent excess weight loss. Six months after the balloons were removed . percent of the average total weight lost during the treatment period was maintained. Researchers say a single adverse event a bleeding gastric ulcer occurred in one balloon patient on high dose NSAIDs who had an outpatient knee replacement procedure. Nonserious adverse device events mostly abdominal cramping and nausea occurred in . percent of patients . were rated mild or moderate. There is no magic pill for obesity but this swallowable balloon and other intragastric balloons may offer new hope to people who otherwise would not seek treatment or not have as good a result with diet and exercise alone said Raul J. Rosenthal MD ASMBS President and Chairman Department of General Surgery Cleveland Clinic Florida who was not involved in the study. The balloon and other technologies may help to fill the therapeutic gaps between diet and exercise and medical therapy and medical therapy and surgery where the gaps are quite large. People with obesity and severe obesity have higher rates of heart disease diabetes some cancers arthritis sleep apnea high blood pressure and dozens of other diseases and conditions. Studies have shown individuals with a BMI greater than have a to percent greater risk of premature death compared to healthy weight individuals. Metabolicbariatric surgery has been shown to be the most effective and long lasting treatment for severe obesity and many related conditions and results in significant weight loss. The Agency for Healthcare Research and Quality AHRQ reported significant improvements in the safety of metabolicbariatric surgery due in large part to improved laparoscopic techniques. The risk of death is about . percent and the overall likelihood of major complications is about percent. According to the Centers for Disease Control and Prevention CDC https in the prevalence of obesity was just over percent in adults with a higher prevalence among women than men . vs. . and older than younger adults vs. .. Obese is medically defined as having a body mass index BMI a measure of height to weight thats more than . The ASMBS estimates about million Americans have severe obesity which would mean a BMI of or more with an obesityrelated condition like diabetes or a BMI of . About the ASMBSThe ASMBS is the largest organization for bariatric surgeons in the nation. It is a nonprofit organization that works to advance the art and science of bariatric surgery and is committed to educating medical professionals and the lay public about bariatric surgery as an option for the treatment of morbid obesity as well as the associated risks and benefits. It encourages its members to investigate and discover new advances in bariatric surgery while maintaining a steady exchange of experiences and ideas that may lead to improved surgical outcomes for morbidly obese patients. For more information visit http A month Swallowable Balloon System results in sustainable weight loss at year results from a prospective randomized shamcontrolled trial Aurora Pryor Stony Brook NY James Swain Scottsdale Arizona George Woodman Memphis Tennessee Steven Edmundowicz Aurora Colorado Tarek Hassanein Coronado California Vafa Shayani Hinsdale IL John Fang Salt Lake City UT mark noar towson md George EidPittsburgh PA Wayne English Nashville TN Nabil Tariq Houston TX Michael Larsen Seattle WA Sreenivasa Jonnalagadda Kansas City MO Dennis Riff Anaheim Ca Jaime Ponce Chattanooga TN Shelby Sullivan St. Louis MissouriStony Brook University Honor Health Mid South Bariatrics University of Colorado Denver University of California San Diego Franciscian St. james Health University of Utah Mark D Noar and Assoc West Penn Allegheny Health System Vanderbilt University Methodist Hospital Houston Virginia Mason University St. Lukes Hospital of Kansas City Anaheim Regional Medical Center Dalton Surgical Group Washington University St. Louis Office of the Surgeon General U.S. Department of Health and Human Services. . Overweight and obesity health consequences. Accessed October from http_consequences.html Kaplan L. M. . Body weight regulation and obesity. Journal of Gastrointestinal Surgery. pp. . Doi.SX. Encinosa W. E. et al. . Recent improvements in bariatric surgery outcomes. Medical Care. pp. . Accessed October from http Agency for Healthcare Research and Quality AHRQ. . Statistical Brief . Bariatric Surgery Utilization and Outcomes in and . Accessed October from http Flum D. R. et al. . Perioperative safety in the longitudinal assessment of bariatric surgery. New England Journal of Medicine. pp.. Accessed October from httpcontent.nejm.orgcgicontentfull"

"Allergan plc NYSE AGN httpstudio.financialcontent.comprnewsPageQuoteTickerAGN today announced that the CoolSculpting treatment is the first and only nonsurgical fat reduction technology to be FDAcleared for improved appearance of lax tissue in conjunction with submental fat or double chin treatments. CoolSculpting for the double chin is already clinically proven to reduce fat up to percent in the treated area after one treatment. Allergan is committed to advancing innovation for CoolSculpting to meet the needs of patients seeking noninvasive aesthetic treatments said David Nicholson Chief Research and Development Officer at Allergan. A American Society for Dermatologic Surgery ASDS survey revealed that percent of patients are bothered by excess fat under the chin. We are pleased this patient concern can successfully be addressed by CoolSculpting through a noninvasive approach and furthermore improve the appearance of lax tissue in the treated area. An week clinical study of CoolSculpting in submental fat treatment found that percent of patients showed improved appearance of lax tissue and percent of patients reported their chin looked more toned following treatment. In my own patients I have noticed the improved appearance of lax tissue when using the CoolMini applicator for the CoolSculpting system to treat the submental area said Jeffrey S. Dover MD FRCPC CoDirector of SkinCare Physicians of Chestnut Hill Mass. It is great to see the company invest to validate this and secure the FDA clearance. CoolSculpting is available through a network of CoolSculpting Centers worldwide. Dermatologists plastic surgeons and aesthetic specialists that offer CoolSculpting can be found at http References Data On File Allergan Inc. Safety and Efficacy of Cryolipolysis for NonInvasive Reduction of Submental Fat ASDS Consumer Survey Data on File Allergan Inc. Study to Evaluate NonInvasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis About the CoolSculpting Treatment CoolSculpting is a nonsurgical clinically proven treatment that selectively reduces unwanted fat using a patented cooling technology. Cleared by the FDA CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural controlled elimination of fat cells without affecting surrounding tissue and the treated fat cells are gone for good. Millions of CoolSculpting treatments have been performed in more than countries. CoolSculpting is available through a network of CoolSculpting Centers worldwide. Dermatologists plastic surgeons and aesthetic specialists that offer CoolSculpting can be found at https_fG_GGkiRxEaLmhqmanWVMeVXRrTcVRxzskvI_VlsLjWXqMgLlzXlWI. In the U.S. the CoolSculpting procedure is FDAcleared for the treatment of visible fat bulges in the submental area thigh abdomen and flank along with bra fat back fat underneath the buttocks also known as banana roll and upper arm. It is also FDAcleared to affect the appearance of lax tissue with submental area treatments. During the procedure you may experience sensations of pulling tugging mild pinching intense cold tingling stinging aching and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure typical side effects include temporary redness swelling blanching bruising firmness tingling stinging tenderness cramping aching itching or skin sensitivity and sensation of fullness in the back of the throat after submental area treatment. Rare side effects may also occur. The CoolSculpting procedure is not for everyone. You should not have the CoolSculpting procedure if you suffer from cryoglobulinemia cold agglutinin disease or paroxysmal cold hemoglobinuria. The CoolSculpting procedure is not a treatment for obesity. Please see full Important Safety Information http_Patient_Safety_Info_proof.pdf for additional information. Be sure to follow CoolSculpting on Facebook https Twitter https Pinterest https_syBwQunMraQE_fyaluRaYxVezzwZGYWSciNADysQauWYhgaYkG_sIwp_TzIAMmkVFxJreesSBlqtBs and YouTube https About Allergan plc Allergan plc NYSE AGN httpstudio.financialcontent.comprnewsPageQuoteTickerAGN headquartered in Dublin Ireland is a bold global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing manufacturing and commercializing branded pharmaceutical device biologic surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and bestinclass products for the central nervous system eye care medical aesthetics and dermatology gastroenterology womens health urology and antiinfective therapeutic categories. Allergan is an industry leader in Open Science a model of research and development which defines our approach to identifying and developing gamechanging ideas and innovation for better patient care. With this approach Allergan has built one of the broadest development pipelines in the pharmaceutical industry with midtolate stage pipeline programs currently in development. Allergans success is powered by our more than global colleagues commitment to being Bold for Life. Together we build bridges power ideas act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately countries Allergan is committed to working with physicians healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer healthier lives every day. For more information visit Allergans website at http ForwardLooking Statement Statements contained in this press release that refer to future events or other nonhistorical facts are forwardlooking statements that reflect Allergans current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergans current expectations depending upon a number of factors affecting Allergans business. These factors include among others the difficulty of predicting the timing or outcome of FDA approvals or actions if any the impact of competitive products and pricing market acceptance of and continued demand for Allergans products the impact of uncertainty around timing of generic entry related to key products including RESTASIS on our financial results uncertainty associated with financial projections projected cost reductions projected synergies restructurings increased costs and adverse tax consequences difficulties or delays in manufacturing and other risks and uncertainties detailed in Allergans periodic public filings with the Securities and Exchange Commission including but not limited to Allergans Annual Report on Form K for the year ended December and Allergans Quarterly Report on Form Q for the period ended September . Except as expressly required by law Allergan disclaims any intent or obligation to update these forwardlooking statements. ICA CONTACTS Allergan Investors Daphne Karydas Media Mark Marmur Marlo Rodman SOURCE Allergan plc Related Links http"

"A protein present on tiny particles released by cancer cells may provide a way to detect pancreatic cancer in its earliest stage when prospects for successful treatement are best according to a study by researchers at the University of Texas M.D. Anderson Cancer Center. The researchers found that the presence of the protein could distinguish with percent accuracy whether patients had early stage pancreatic cancer or chronic pancreatitis a major risk factor for the cancer. Levels of the protein were markedly lower after surgical removal of a patients tumors. The study was published http in the June issue of the journal Nature. Pancreatic cancer has one of the lowest survival rates of any cancer with only percent of patients surviving five years after diagnosis. That is due in part to the lack of any easy way to detect the cancer in its earliest stages. The pancreas is located deep within the body so early tumors cannot be seen or felt during routine physical exams. Patients usually have no symptoms until the cancer has spread. Scientists have uncovered various markers that can be used to detect the cancer through a blood test but those have been too unreliable to recommend widespread screening. As a result percent of pancreatic cancer is diagnosed in later stages when surgery is no longer an option. The new finding could lead to a blood test that would allow doctors to screen for pancreatic cancer much more effectively. If such a test were developed it would likely be used first to test patients at high risk for pancreatic cancer. If it can be shown that screening improved outcomes it could one day be used to screen the general population. Studies comparing stage of disease with outcome following surgery suggest that death rates frompancreatic cancer would be reduced if the disease were diagnosed at an earlier stage said Dr. Raghu Kalluri chair of cancer biology at M.D. Anderson and a coauthor of the study. This presents an unprecedented opportunity for informative early detection of pancreatic cancer and in designing potential curative surgical options."

"Palo Alto Health Sciences Inc. PAHS developer of the drugfree Freespira treatment for panic attacks and other symptoms of panic disorder today announced that another study has demonstrated clinically significant symptom improvement with of patients panic attack free one year after treatment. This latest study conducted as part of the VITAL Program at Allegheny Health Network in Pennsylvania also demonstrated a reduction in healthcare costs in patients with panic symptoms months after being treated with Freespira. A Symposium at the Anxiety and Depression Association of America ADAA Annual Conference in Washington DC focused on the impact of abnormal breathing patterns on anxietyrelated conditions and treatments as reported in five studies. Two studies reported nearly of Freespiratreated patients were panic attack free at months posttreatment. Two additional studies reported that patients with mixed anxiety disorders and low exhaled CO at baseline were less responsive andor discontinued treatment with Cognitive Behavioral Therapy or Acceptance Commitment Therapy. Early data from a fifth study reported on Freespira treatment for patients with PostTraumatic Stress Disorder PTSD. Ninety percent of patients in this study experienced a significant improvement in PTSD symptoms at two months and six months posttreatment. Symposium Chair David Tolin Ph.D. Director of Anxiety Disorders Center The Institute of Living and Adjunct Professor of Psychiatry Yale University School of Medicine commented Studies of the Freespira treatment have shown that this innovative approach to treating patients suffering from panic symptoms and panic attacks not only significantly reduces or eliminates these symptoms in approximately of patients but also results in meaningful reduction in health costs. Debra Reisenthel CEO of Palo Alto Health Sciences added Patients with panic symptoms and panic attacks have times higher medical costs than patients without panic due to higher utilization of medical resources including ED visits physician visits and prescription drugs. Freespira is both easy to use and effective. Once a licensed healthcare provider authorizes the treatment and after a single training session the patient uses Freespira at home performing two minute breathing sessions a day over a fourweek period after which the treatment is complete. The peerreviewed published multicenter Freespira clinical trial presented by Dr. Tolin demonstrated that of patients were panic attack free immediately after treatment and of patients were panic attack free months posttreatment. About Freespira Freespira is an FDAcleared drugfree fourweek athome treatment for panic attacks and other panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder a mental health condition in which debilitating anxiety leads to lifealtering avoidance behaviors. Individuals with panic chronically hyperventilate even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate attacks. Freespira works by training the patient to stabilize respiration rate and exhaled carbon dioxide levels which reduces or eliminates panic attacks. About Palo Alto Health Sciences Inc. Palo Alto Health Sciences Inc. is a privately held digital therapeutic company revolutionizing behavioral healthcare with evidencebased noninvasive drugfree solutions. Their first product Freespira is an FDAcleared treatment for individuals suffering from panic disorder panic attacks and other symptoms of panic. In the United States over . million adults annually suffer from panic disorder panic attacks affect a total of million adults in the U.S. every year and are a common component of other anxiety disorders. Freespira is commercially available throughout the U.S. To learn more visit http or contact infopahealthsciences.com mailtoinfopahealthsciences.com. MEDIA CONTACT Michele Kong SOURCE Palo Alto Health Sciences Related Links httpfreespira.com"

"Nearly three decades have passed since the debate began about a series of symptoms that have come to be known as chronic fatigue syndrome http Its cause http is still unknown but over the years researchers have identified various brain immune system and energy metabolism irregularities involved. Some patients describe the syndrome as feeling like an unrelenting unremitting flu. Doctors say some treatments can help. Arthur Barsky http_barsky.aspx a psychiatrist at Brigham and Womens Hospital in Boston and a professor at Harvard Medical School says patients need to change how they experience symptoms typically pain insomnia and anxiety. When patients adopt a more positive attitude Barsky points out it often translates into greater confidence and more energy. A study http published this year in the Lancet found that a form of talk therapy as well as exercise offered relief for some patients. Researchers from the United Kingdom looked at cognitive behavior therapy http or CBT. In the study over patients with chronic fatigue syndrome were assigned to different treatments. All of them received medical care for symptoms like pain insomnia or anxiety. Article continues after this message from our sponsor Hear Joanne Silberners Report Medical Mystery Of Chronic Fatigue Syndrome Returns https Sept. One group got counseled about how to pace activities. Another took part in an exercise program. And a third received the cognitive behavioral talk therapy. The therapy and the exercise group improved the most reporting less fatigue insomnia and anxiety. Barsky says his patients do best when cognitive behavior therapy is also combined with gradually increased exercise. People need to begin to push themselves in the face of their fatigue because if you dont you become deconditioned and you get caught in a cycle which ... makes fatigue worse says Barsky. But he cautions against overdoing it. People should start with mild gentle exercise like clearing the table doing the dishes or taking the dog for a short walk. Then slowly build up to longer and more frequent walks he says. Lucinda Bateman http is a doctor at the Fatigue Consultation Clinic in Salt Lake City who specializes in chronic fatigue syndrome. Shes skeptical about the Lancet study pointing out that patients improved only moderately and not much more than those who were counseled about pacing themselves. Bateman suggests her patients pace themselves and try to do only as many activities as they can manage. She says some patients get caught in a push and crash cycle. When symptoms abate and they feel better they may go all out exercising doing errands and socializing. But soon that level of activity often comes to a crashing end and patients can relapse dramatically even becoming bedridden for several days or longer. Bateman takes also issue with CBTs implication that chronic fatigue syndrome is psychosomatic. We still dont know what exactly causes the syndrome. And like most professionals who treat patients Bateman eagerly awaits the day when science can finally pinpoint its cause."

"Its still very early but scientists say a test based on a patients saliva might someday help detect Alzheimers disease. Saliva is easily obtained safe and affordable and has promising potential for predicting and tracking cognitive decline but were in the very early stages of this work and much more research is needed study author Shraddha Sapkota a neuroscience graduate student at the University of Alberta in Canada said in a news release from the Alzheimers Association. The study was to be presented Sunday at the Alzheimers Association International Conference in Washington D.C. Experts note that studies presented at medical meetings are typically considered preliminary until published in a peerreviewed journal. In the study Sapkotas team tested the saliva of people with Alzheimers disease people with whats known as mild cognitive impairment a decline in memory and thinking thats sometimes a precursor to dementia as well as people whose mental skills were normal for their age. They found that the saliva of people with Alzheimers had different levels of certain substances compared to the saliva of healthy people or those with mild cognitive impairment. Experts agreed that the findings held promise but much more research will be needed. This is a very preliminary study with a small number of subjects and the results are far from conclusive said Dr. Allison Reiss head of the Inflammation Section at WinthropUniversity Hospital in Mineola N.Y. She believes the current study lacks information on possible confounding factors things such as coexisting illnesses medications hydration state tobacco use and multiple other variables that could influence whats found in the saliva samples. There are many gaps in the evidence Reiss said. It is uncertain whether the strength and consistency of the relationship between these metabolites in saliva and Alzheimers risk will be maintained in a large multicenter study. Still Dr. Paul Wright chair of neurology at North Shore University Hospital in Manhasset N.Y. said the research is still in its infancy but very promising. If a saliva test lives up to its promise one advantage is the ease of obtaining a sample he said. But that convenience also brings its own problems Wright added. People might ask for a test even when they dont show any signs of dementia and this may result in anxiety and depression if there is a false positive result he said. For that reason larger studies are needed to corroborate and validate their findings Wright said. More information The U.S. National Institute on Aging has more about Alzheimers disease https SOURCES Paul Wright M.D. chair neurology North Shore University Hospital Manhasset N.Y. and Long Island Jewish Medical Center New Hyde Park N.Y. Allison Reiss M.D. head Inflammation Section WinthropUniversity Hospital Mineola N.Y. Alzheimers Association news release July"

"Each year five million people have wisdom teeth removed but its up in the air whether all of those surgeries were necessary. Wisdom teeth httpmyoms.orgprocedureswisdomteethmanagement also called the third molars are four teeth that grow at the very back of each corner of the mouth. For most people they start to grow in between ages and . Theyre thought to crowd out other teeth or cause tooth decay which is why many dentists and oral surgeons think its better to just nip those problems in the bud and take them out as a preventative measure. But theres a serious debate between dentists and oral surgeons should they preemptively remove someones wisdom teeth if the patient doesnt have any symptoms Simply put theres no right answer. It comes down to what you as a patient want. Heres what you need to know to figure that out. Dentists and oral surgeons are fighting over wisdom teeth Dentists and oral surgeons agree across the board that theres cause to remove wisdom teeth if a patient is in pain or if there are signs of disease popping up like tooth decay or infection. Thats an obvious choice. But taking out wisdom teeth when there arent any symptoms is where the professionals get into it. Many dental professionals stick with a watch and wait approach with wisdom teeth to avoid surgery if possible. Many people dont have adequate space in their jaw for the teeth to come into full position but that alone isnt justification of having them all removed says Dr. Scott Tomar of University of North Carolinas School of Dentistry. Tomar says that as a dentist he feels the risks of complication including infection and hitting nerves during surgery outweigh any benefits of preventative removal. In oral surgeon Dr. Jay Friedman called the preventative removals a public health hazard http in the American Journal of Public Health. The American Public Health Association has sided with this argument since when it formally opposed http the preventative removal of wisdom teeth. The same thing happened with tonsils http which doctors no longer remove just to get rid of the chance of infection later on. Americans spend an estimated billion a year having their wisdom teeth removed Some doctors though still see preventative oral surgery as being two steps ahead of the problem. If youre going to need your wisdom teeth out eventually why not have them removed when youre younger and are more likely to recover more easily Some think of removing the wisdom teeth early on as a way to lessen the crowding of other teeth You might not have symptoms now but you cant assume its gonna be that way for the rest of your life says Dr. Ray White an oral surgeon working at University of North Carolina. Rather than let the teeth cause problems later on many oral surgeons remove them. But a Cochrane review httpsummaries.cochrane.orgCDORAL_surgicalremovalversusretentionforthemanagementofasymptomaticimpactedwisdomteeth of randomized clinical trials found theres no evidence that removing wisdom teeth will prevent or reduce crowding of other teeth down the line. And a different Cochrane review http found that watching and waiting can may reduce the number of surgical procedures by percent or more. The question comes down to which side of the fence medical professionals fall on Its worth noting that oral surgeons make a good chunk of their paychecks by removing wisdom teeth so there is a financial incentive involved. Are there people gaming the system Sure. You dont get paid much for not doing anything White says. But Id hope we can get past that. The American Association of Oral and Maxillofacial surgeons says There is no pat answer https_based_third_molar_surgery.pdf cookbook recipe or flow chart that is universally accepted regarding the decision making process in these cases. So the question comes down to which side of the fence medical professionals fall on and what works best for their patients. The risks and benefits of removing your wisdom teeth Theres a chance that if you opt not to have your wisdom teeth taken out they might be fine for the rest of your life. Theres also a chance that theyll need to come out later. If thats the case you cant always plan for it. Opting to have them removed gives patients time to plan around the procedure which leaves people out of commission for about three days. But inconvenience isnt the only risk. The risk for complications increases as people get older and the duration of disability after the operation gets longer as people get older says oral surgeon Dr. Thomas Dodson. In some cases the extraction can be more painful if you wait Dodson says. Thats because the tooth is easier to remove if its roots arent fully developed. The common risks http related to the surgery include poor wound healing infection pain and uncontrolled bleeding. Nerve injury in rare cases of wisdom teeth removal can leave people with permanent numbness around the face and mouth according to the APHA. Americans spend billions each year on wisdom teeth Americans spend an estimated billion a year having million wisdom teeth removed http according to the American Public Health Association. Thats a hefty bill for something we may or may not need. How much it costs depends on how the molars are situated. A simple surgical extraction for a wisdom tooth thats showing through the gums should run about httpshealthcarebluebook.compage_ProcedureDetails.aspxiddatasetdentalgSurgicaltoothremoval according to Healthcare Bluebook. If its impacted pushed against another tooth and unable to fully come through the gum the cost jumps to about httpshealthcarebluebook.compage_ProcedureDetails.aspxiddatasetdentalgImpactedtoothremovalcompletelybony per tooth."

"This is cancer therapy at its most aggressive a treatment patients liken to being filleted disemboweled and then bathed in hot poison. The therapy which couples extensive abdominal surgery with blasts of heated chemotherapy to the abdominal cavity and its organs was once a niche procedure used mainly against rare cancers of the appendix. Most academic medical centers shunned it. More recently as competition for patients and treatments intensifies an increasing number of the nations leading medical centers has been offering the costly and controversial therapy to patients with the more common colorectal or ovarian cancers. And some hospitals are even publicizing the treatment http as a hot chemo bath. To critics the therapy is merely the latest example of one that catches on with little evidence that it really works. Were practicing this technique that has almost no basis in science said Dr. David P. Ryan clinical director of the Massachusetts General Hospital Cancer Center. But to some patients the procedure however grueling and invasive represents their best hope for survival Its throwing everything but the kitchen sink at cancer said Gloria Borges a yearold Los Angeles lawyer who had her colon cancer treated with what she called the pick it out pour it in procedure. If it were our motherfathersisterbrotherchildbest friend what price would we put on the additional daysweeksmonthsyears of Life... For hours on a recent morning at the University of California San Diego Dr. Andrew Lowy painstakingly performed the therapy on a patient. After slicing the mans belly wide open he thrust his gloved hands deep inside and examined various organs looking for tumors. He then lifted the small intestine out of the body to sift it through his fingers. As he found tumors he snipped them out. You can see how this is coming off like wallpaper Dr. Lowy said as he stripped out part of the lining of the mans abdominal cavity. After about two hours of poking and cutting Dr. Lowy began the socalled shake and bake. The machine pumped heated chemotherapy directly into the abdominal cavity for minutes while nurses gently jiggled the mans bloated belly to disperse the drug to every nook and cranny. The treatment is formally called cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy or Hipec. Recent converts include University Hospitals Case Medical Center in Cleveland Montefiore Medical Center in the Bronx and even Massachusetts General. The Memorial SloanKettering Cancer Center is looking at it according to people in the field. Advocates predict that the number of procedures could grow to a year from about now. The therapy has even been featured on an episode of the TV series Greys Anatomy. But Dr. Ryan a gastrointestinal oncologist suggested in an interview that the procedure was being extended to colorectal cancer because you cant make a living doing this procedure in appendix cancer patients. He debated the procedure http_session_presentations_viewconfIDtrackIDsessionID publicly at the recent annual meeting of the American Society of Clinical Oncology. While some patients did seem to live much longer than expected he said that they had been carefully selected and might have fared well even without the therapy. Proponents say that if cancer has spread into the abdominal cavity but not elsewhere then lives can be prolonged by removing all the visible tumor and killing whats missed with Hipec. By contrast said Dr. Paul Sugarbaker a surgeon at Washington Hospital Center and the leading proponent of Hipec there are no longterm survivors with systemic chemotherapy zero. Dr. Sugarbaker who opposed Dr. Ryan in the debate said that it has long been known that cancerous cells are unable to withstand as much heat as healthy cells. And putting the chemotherapy on top of tumors should be more effective than systematically delivering it through the bloodstream. One randomized trial httpjco.ascopubs.orgcontent.full done more than a decade ago involving patients in the Netherlands did show a striking benefit. The median survival of those getting surgery and Hipec plus intravenous chemotherapy was . months almost double the . months for those getting only the intravenous chemotherapy. But percent who got the surgery and Hipec died from the treatment itself. And critics say that since that trial was conducted new drugs have come to market that allow patients with metastatic colorectal cancer to live two years with intravenous chemotherapy alone. A new trial in the United States has been temporarily suspended so that researchers can find a way to recruit patients. After nearly a year only one patient had enrolled because people were reluctant to chance winding up in the control group according to one of the investigators. While proponents contend that the risk of dying from the surgery has been reduced since the Dutch trial the procedure still lasts eight hours or more and full recovery can take three to six months. Its maximally invasive said Dr. Sugarbaker who often removes the spare parts organs a patient can live without like the spleen the gall bladder the ovaries and the uterus. The cost of the surgery and Hipec including hospitalization ranges from to more than doctors said. While Medicare and insurers generally pay for the operation the heated treatment may not be covered. But doctors added it may be if it is described merely as chemotherapy. Some patients like Ms. Borges who is a fitness devotee recover well and say the procedure staved off a death sentence. But Dr. Alan Venook a colon cancer specialist at the University of California San Francisco said that a couple of patients referred by him had died miserable deaths. One lost much of her abdominal wall to infection and just died in misery. Another risk is that the surgery may be done unnecessarily. CT scans cannot pick up many of the small tumors so it is often unclear how much cancer is inside until the patient is opened. In June Dr. Lowy sliced open a woman and saw to his horror that she had more tumors than he could remove. Taking out only some would not improve her chances of survival so he closed the incision and she is now starting intravenous chemotherapy. Things with the male patient Andy S. went better. A yearold father of two from near San Francisco Mr. S. agreed to let a reporter observe the surgery but asked that his full name not be published because he did not want his cancer history to surface through Web searches. Mr. S. had abdominal pain eventually diagnosed as appendicitis. But the appendix was found to be cancerous. Such cancers typically spew mucus containing tumor cells into the abdominal cavity. So he signed up for surgery and Hipec with Dr. Lowy. Ive had to say my goodbyes to everybody Mr. S. said the day before the operation. I had to talk to my priest. I had to do all these things I never thought Id have to do at . I wouldnt wish it on my worst enemy but I have to go through with it. Dr. Lowy explored the entire cavity from the diaphragm to the pelvis. He found mucus in several spots that he sopped up with a cloth and also tiny tumors the size of a pencil eraser that had implanted in several spots. He snipped those out and sewed up the wounds. He removed the right side of the mans colon and the omentum a fatty structure. Then two Yshaped tubes hooked to the Hipec machine were inserted into the abdominal cavity one to deliver the chemotherapy and the other to bring the drug back to the machine to be reheated. The incision was sewn up around the tubes so the chemotherapy would not leak. The mans belly was filled with three liters of saline fluid and the chemotherapy a generic drug called mitomycin C heated to degrees Celsius or nearly degrees Fahrenheit. Any hotter could have caused injuries. Bloated with liquid the mans torso resembled a water bed. After minutes the fluid was drained and the incision reopened for a final check before the patient was stitched up. The procedure took six hours. We got all of the visible disease and he didnt have a lot of visible disease Dr. Lowy said with satisfaction. Mr. S. left the hospital eight days later happy to have undergone the treatment. I want to have the best chance I can have to never see this again he said."

"Children in rural Nepal whose mothers were given iron and folic acid supplements during pregnancy were smarter more organized and had better fine motor skills than children whose mothers did not get them U.S. researchers said on Tuesday. A store worker walks past rows of herbal vitamin and mineral pill products at a pharmacy in this file photo. REUTERSDavid Gray They said ensuring that pregnant women get this basic prenatal care could have a big effect on the educational futures of children who live in poor communities where iron deficiency is common. Iron is essential for the development of the central nervous system said Parul Christian an expert in international health at the Johns Hopkins University Bloomberg School of Public Health whose study appears in the Journal of the American Medical Association. Iron deficiency is the most common and widespread nutritional disorder in the world affecting billion people according to the World Health Organization. Early iron deficiency can interfere with nerve development biochemistry and metabolism hampering both intellectual and fine motor development. Christians team studied schoolage children whose mothers had been in a clinical trial in which some got iron and folic acid supplements and other nutrients while they were pregnant. About percent of the children aged to were enrolled in school. We had the opportunity to follow the offspring of women who had participated in a randomized trial of iron and folic acid and other micronutrients to assess neurocognitive function and outcomes Christian said in a telephone interview. What we showed is prenatal iron and folic acid supplementation had a significant impact on the offsprings intellectual level and motor ability and ability during school age which was a very exciting finding she said. It had an impact across a range of function including intellectual function executive function and fine motor function factors that could affect a childs later academic success Christian said. She said many children in poor communities would benefit from better prenatal programs that include the lowcost nutritional supplements. These results speak to a large swath of people residing in that part of the world. Iron and folic acid deficiency are very common she said. The World Health Organization estimates that in developing countries every other pregnant woman is anemic and about percent of preschool children are anemic. The study was funded by the National Institutes of Health and the Bill Melinda Gates Foundation. Ford and VW are exploring closer cooperation as trade frictions force carmakers to rethink where they build cars for Europe the United States and China and as software companies prepare to launch their own selfdriving cars. A global alliance is expected to be announced one source said adding that the pact will be unveiled next Tuesday. The scope of the alliance is still being determined the sources said as talks about cooperation in the area of electric and autonomous cars continue. Talks are going well said a second source who declined to be named. Volkswagen is reviewing whether to invest in Fords autonomous vehicles division while Ford executives are considering licensing Volkswagens MEB electric vehicles platform the second source said. Ford and VW had no immediate comment. In June Ford and VW unveiled a pact in commercial vehicles including vans adding that they were investigating several joint projects. U.S. China could settle immediate trade issues Ross In December VW CEO Herbert Diess said We are in quite advanced negotiations and dialog with Ford Corporation to really build up a global automotive alliance which also would strengthen the American automotive industry. At the time Ford Executive Chairman Bill Ford Jr told reporters that talks with Volkswagen about an alliance were going very well The auto show runs from January to January . Reporting by Jan Schwartz in Hamburg and Ben Klayman in Detroit Writing by Edward Taylor Editing by Joe White Georgina Prodhan and Elaine Hardcastle Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"