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"Patients with depression often struggle through weeks or months of trialanderror to find the right antidepressant. Now the burgeoning field of pharmacogenomics how genes affect a persons response to drugs is helping more patients avoid debilitating and alltoocommon side effects of psychiatric medications. Sarah Ellis will never forget her darkest days battling depression and the series of prescriptions the Sioux Falls South Dakota mother of three endured. I tried every medicine Ellis said. I wondered if I would ever find something that works. One prescription gave her a rash for two years and the antianxiety medication Clonazepam Klonopin affected her balance. She was also prescribed selective serotonin reuptake inhibitors SSRIs a class of drugs including Prozac which are used to treat anxiety and depression but they made me feel like I was losing my mind Ellis told NBC News. More than in American ages and older are struggling with depression according to the Centers for Disease Control and Prevention. And many more are suffering from sometimes severe side effects like weight gain nausea sleepiness and sexual problems. At least adverse drug reactions linked to antidepressants were reported to the Food and Drug Administrations Adverse Event Reporting System between and . Its unclear how many patients have had to stop or chosen to stop treatment for depression due to side effects. Ellis tried different combinations of depression medications. Finally her psychiatrist suspicious that her body might process medication differently than most recommended a genetic test to see why Ellis wasnt responding to the prescriptions. Once the genetic testing became available it provided Sarah with more than just physical relief says Dr. Matthew B. Stanley of the Avera Medical Group in Sioux Falls South Dakota. It gave us an answer that this was her physiology and her genetics and not something in her head. The Avera Institute for Human Genetics AIHG in Sioux Falls South Dakota is among several institutions exploring the role of pharmacogenomics the science of how our inheritance and genetic makeup influences the way we metabolize medications. One piece of the puzzle AIHGs pharmacogenomics research has led to the development of Genefolio a genetic test that uses an individuals unique DNA to predict how that individual will respond to medications. The test offered by Avera is and is often covered by insurance. Research pharmacist Krista Bohlen director of personalized pharmaceutical medicine at the Avera Institute for Human Genetics believes that genetics play a large role in how different individuals react to certain medications but cautions doctors and patients against relying solely on this method for answers. According to a study conducted by the Mayo Clinic that looked at one genetic test similar to many used in hospitals GeneSight Psychotropic symptoms of depression were reduced by percent compared to treatments prescribed without genetic testing. While the results are striking this technology is not a guarantee of complete resolution of depressive symptoms or medication side effects. Pharmacogenomics is one piece of the puzzle Bohlen told NBC News. We look at it as a tool to help the physician. They can couple their expert opinions with information from the patient like their symptoms and family history to look more closely at one class of drug over another. Sarah Ellis is sideeffect free and in great spirits now.Courtesy Sarah Ellis The Genefolio test confirmed gene variants within Ellis DNA that made her more susceptible to certain side effects with newer classes of medications so Stanley prescribed an older class of antidepressant and experimented with a lower dose. It worked for Ellis. My energys been really great she says. I feel like I can accomplish what I want to accomplish. This was definitely worth it."

"Can a single ingredient swap make an impact on health According to the recently released Dietary Guidelines for Americans small shifts in food choices can make a big difference including a shift from solid fats to oils like the oil in fresh avocados. On the heels of this advice a new metaanalysis considered the best evidence and an unbiased overview of the body of knowledge on a specific topic published in the Journal of Clinical Lipidology adds to the growing body of research that supports the use of avocados in lieu of solid fats and foods that have higher saturated fat content to significantly change lipid profiles. The research Impact of avocadoenriched diets on plasma lipoproteins A metaanalysis conducted at the University of the Pacific and independently funded looked at unique avocado studies with participants assessing the impact of avocados on cholesterol levels. Researchers found avocado consumption to . per day significantly reduced total cholesterol TC bad low density lipoprotein cholesterol LDLC and triglycerides TG when they were substituted for sources of saturated fat. Additionally avocado consumption did not impact good high density lipoprotein cholesterol HDL. However the optimal amount of avocado and frequency of use needs further evaluation along with the nutritional similarities and differences between other different MUFA sources. Larger trials looking at the impact of avocados on major adverse cardiovascular events are warranted. See conclusion of study Interestingly our results indicate that even healthy subjects with a relatively normal baseline TC to mgdL LDLC to mgdL and TG to mgdL had significant reductions says Sachin Shah PharmD corresponding author and expert in cardiovascular health. As we head into American Heart Health Month February its important to remind people that they have the power to help control their risk factors for developing heart disease by exercising regularly knowing cholesterol levels and keeping them under control and maintaining a healthy weight. Cardiovascular disease is responsible for one out of every four deaths it is the number killer of American women and men and it is a leading cause of disability. Fresh avocado as part of a balanced diet and as a cholesterolfree substitute for solid fats can help be part of the solution for maintaining normal cholesterol levels says Nikki Ford PhD Director of Nutrition Hass Avocado Board. Beyond their naturally good fats avocados are also a delicious way to boost fiber percent of DV and fruit intakes both of which are under consumed in American diets. The Hass Avocado Board HAB continues to be a leader in educating health professionals and consumers on the benefits of avocados. HAB recently created a series of simple quick to prepare interactive meal makeovers https to show people how to make small shifts in their diets by substituting fresh avocados for other foods or ingredients higher in saturated fats. This study supports the body of research showing the many benefits that fresh avocados have to offer when consumed in everyday healthy eating plans says Emiliano Escobedo Executive Director HAB. Through our nutrition research program established in we are committed to increase awareness and improve understanding of the unique benefits of avocados to human health and nutrition. Clinical studies are currently underway to investigate the relationship between avocado consumption and risk factors for heart disease diabetes support of weight management and healthy living. To view the abstract or the published article visit http About the Hass Avocado Board The Hass Avocado Board HAB is an agriculture promotion group established in to promote the consumption of Hass Avocados in the United States. A member board representing domestic producers and importers of Hass Avocados directs HABs promotion research and information programs under supervision of the United States Department of Agriculture. Funding for HAB comes from Hass avocado producers and importers in the United States. In HAB established a nutrition research program to increase awareness and improve understanding of the unique benefits of avocados to human health. For a comprehensive collection of published nutrition and scientific literature authoritative reports and other articles on or related to avocados their nutrients and eating patterns that include them visit avocadonutritioncenter.com. For tips and recipes visit LoveOneToday.com https_sourceloveoneredirectutm_mediumloveonetodayutm_campaignLOT or follow HAB on Facebook https Twitter httpstwitter.comHassAvocados Pinterest https and YouTube https"

"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. We 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 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 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."

"Instead of shrinking as expected as part of the normal aging process the memory center in the brains of seniors maintained their size and in men grew modestly after two years in a program that engaged them in meaningful and social activities new Johns Hopkins Bloomberg School of Public Healthled research suggests. At the same time those with larger increases in the brains volume over two years also saw the greatest improvements on memory tests showing a direct correlation between brain volume and the reversal of a type of cognitive decline linked to increased risk for Alzheimers disease. The research published online in Alzheimers Dementia The Journal of the Alzheimers Association studied participants in the Baltimore Experience Corps a program that brings retired people into public schools to serve as mentors to young children working with teachers to help them learn to read in understaffed school libraries. Someone once said to me that being in this program removed the cobwebs from her brain and this study shows that is exactly what is happening says study leader Michelle Carlson PhD an associate professor in the Department of Mental Health at the Johns Hopkins Bloomberg School of Public Health. By helping others participants are helping themselves in ways beyond just feeding their souls. They are helping their brains. The brain shrinks as part of aging but with this program we appear to have stopped that shrinkage and are reversing part of the aging process. For the study Carlson and her colleagues randomized men and women to either participate in the Experience Corps or not . They took MRI scans of their brains at enrollment and then again after and months. They also conducted memory tests. Participants were an average of . years old predominantly AfricanAmerican were in good health came from neighborhoods with low socioeconomic status and had some college education. The control arm of the study those not involved in Experience Corps exhibited agerelated shrinkage in brain volumes. Typically annual rates of atrophy in adults over age range from . percent to two percent. The men who were enrolled in Experience Corps however showed a . percent to . percent increase in brain volumes over the course of two years. Though not statistically significant women appeared to experience small gains as compared to declines in the control group of one percent over months. Carlson notes that many cognitive intervention studies last one year or less. One strength of this study she says is that the participants were followed for two years which in this case was long enough to see changes that wouldnt have been detected after just one year. The researchers were particularly interested in the results considering that people with less education and who live in poverty are at greater risk for cognitive decline. Carlson says its not entirely clear which elements of Experience Corps account for the improved memory function and increased brain volumes. She says the program increases involvement in so many different kinds of activities that retired people may not have engaged in otherwise. Participants need to get out of bed walk to the bus and walk up and down stairs inside the schools. They work in teams. They work with young people. They share their knowledge and know they are doing good in the world. They engage in problem solving and they socialize in ways they wouldnt have if they stayed at home. Were not training them on one skill like doing crossword puzzles she says. Were embedding complexity and novelty into their daily lives something that tends to disappear once people retire. The same things that benefit us at contact with others meaningful work are certain to benefit us as we age. Experience Corps is a national program however it can be costly and isnt available everywhere. But Carlson says she believes finding purpose and civic engagement may forestall some of the damage of aging on the brain. Impact of the Baltimore Experience Corps Trial on cortical and hippocampal volumes was written by Michelle C. Carlson Julie H. Kuo YiFang Chuang Vijay Varma Greg Harris Marilyn Albert Kirk I. Erickson Arthur F. Kramer Jeanine M. Parisi QianLi Xue Erwin Tan Elizabeth K. Tanner Alden Gross Teresa E. Seeman Tara Gruenewald Sylvia McGill George W. Rebok and Linda P. Fried. The study was supported by the Johns Hopkins Neurobehavioral Research Unit the National Institutes of Healths National Institute on Aging P AG the Alzheimers Drug Discovery Foundation and the Johns Hopkins Epidemiology and Biostatistics of Aging Research Fellowship NIA TAG."

"A hormone called DHEA and mostly secreted by the adrenal glands may be able to help women who are going through menopause and could also give them better sex lives a study found on Tuesday. Italian researchers writing in the journal of the International Menopause Society Climacteric said they had found the first robust evidence that low doses of DHEA can help sexual function and menopausal symptoms suggesting it may one day become an alternative to hormone replacement therapy HRT. But they stressed that the trial was small so far larger studies are needed to confirm the results. We must bear in mind that this is a pilot study with a small sample Anna Fenton coeditor of Climacteric said in commentary on the work. We cant yet say that this study means that DHEA is a viable alternative to HRT but ... we should be looking to do larger studies to confirm these initial results. DHEA or dehydroepiandrosterone is a natural steroid hormone mostly made in the adrenal glands and has a variety of therapeutic uses. HRT which is a combination of the hormones oestrogen and progesterone is an approved treatment for women going through the menopause who often experience unpleasant symptoms such as hot flushes night sweats loss of sex drive and mood swings. But sales of HRT drugs have fallen sharply since a large study in found higher rates of ovarian cancer breast cancer and strokes in women who took the pills and the search has since been on for alternatives. American researchers said in January that the antidepressant Lexapro made by drugmaker Forest Laboratories significantly cut the number and severity of hot flushes in menopausal women and other antidepressants including GlaxoSmithKlines Paxil and the Pfizer drugs Prozac and Effexor also have been found to be effective. For this trial a team of researchers led by Andrea Genazzani of the University of Pisa followed a group of postmenopausal women with troubling symptoms. Over a year women took vitamin D and calcium took DHEA took standard HRT and took a synthetic steroid called tibolone which is used to alleviate menopausal symptoms. The womens menopausal symptoms sexual interest and activity were measured using a standard questionnaire that explores factors such as satisfaction with frequency of sex vaginal lubrication orgasm and sexual partner. After months all the women on hormone replacements had improvements in menopausal symptoms but those taking vitamin D and calcium did not show any significant improvement. At the start of the trial all groups had similar sexual activity but after the year those taking calcium and vitamin D scored an average of . on the questionnaire scale while those taking DHEA had a score of . showing that those on DHEA had more sexual interest and activity. The results for the HRT group were similar and both the HRT DHEA groups showed a higher level of sexual intercourse in comparison to the control group the researchers said. Genazzani said the results showed DHEA has potential especially for those women who may have problems in taking more conventional HRT. But this is a small study a proof of concept. What we need to do now is to look at a larger study to confirm that these initial results are valid she added. Reporting by Kate Kelland Editing by Jon LoadesCarter Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Men who have a low prostatespecific antigen PSA score when theyre first tested may not need to be screened annually and probably dont need to undergo a biopsy a new study suggests. Dutch researchers presenting the findings at the Genitourinary Cancers Symposium in Orlando Fla. said that few men with a PSA below . ngml were likely to develop prostate cancer and die of the disease. PSA can identify those at low risk of prostate cancer and once you have done that you can remove almost percent of men in the age group to from undergoing biopsies said study senior author Monique Roobol an epidemiologist in the department of urology at Erasmus University Medical Center in Rotterdam. For this study about men aged to in the Rotterdam area were screened with those having PSA scores at or above the cutoff of . sent for biopsies and additional screenings every four years. Eighty percent of men in the group had PSA levels below that threshold. In this group of men the higher the PSA level at baseline the more likely the person was to develop prostate cancer and to die of the disease. Only . percent of men with PSA scores below . were diagnosed with prostate cancer with only . percent dying of the disease. This compares with . percent of those with scores from percent to . percent developing a malignancy and . percent dying of the disease. This gives us some confidence that annual PSA screening is going to soon become a thing of the past said Dr. Nicholas J. Vogelzang chair of the Developmental Therapeutics Committee of US Oncology who moderated the teleconference. A low PSA particularly those in men who have less than . and probably those less than . certainly could be considered for substantially longer intervals of PSA screening... Personalization of PSA screening is clearly underway. A second study also being presented at the symposium found that a drug already used to treat enlarged prostate gland may delay the progression of lowrisk early prostate cancer among men who choose a waitandsee approach to treatment. In comparison to men with lowrisk earlystage prostate cancer who took a placebo men randomized to receive Avodart saw their chance of progression significantly reduced by approximately percent said study author Dr. Neil Fleshner head of urology at the University Health Network and Love Chair in Prostate Cancer Prevention at Princess Margaret Hospital both in Toronto. Men with lowrisk prostate cancer who want to have a period of observation should consider using this drug. But the maker of Avodart dutasteride GlaxoSmithKline is unlikely to apply for new approval to market the drug for what is essentially prevention meaning it would be used offlabel in this context he added. A final study of almost patients found that surgeons needed to perform procedures known as roboticassisted laparoscopic radical prostatectomies RALP to become adept at the procedure. In comparison with typical laparoscopic surgery RALP offers surgeons threedimensional vision and such improvements as better magnification and hand tremor filtering. We recommend that this operation should not be done by all urologists in small community hospitals but should be focused and concentrated on high volume centers of excellence... in order to achieve best possible results for patients said study author Dr. Prasanna Sooriakumaran a visiting fellow in urology at the Weill Cornell Medical College in New York. The procedure is not as easy as manufacturers make it out to be and enthusiasm in the U.S. needs to be tempered in terms of which hospitals should be buying the equipment and which surgeons should be doing these sorts of operations he added. One caution though is that the study only looked at three surgeons performing RALP. More information The National Cancer Institute has more on prostate cancer http SOURCES Feb. teleconference with Nicholas J. Vogelzang M.D. chair and medical director Developmental Therapeutics Committee US Oncology Monique Roobol Ph.D. epidemiologist department of urology Erasmus University Medical Center Rotterdam the Netherlands Neil Fleshner M.D. head urology University Health Network and Love Chair in Prostate Cancer Prevention Princess Margaret Hospital Toronto Prasanna Sooriakumaran M.D. Ph.D. visiting fellow urology Weill Cornell Medical College New York City Feb. presentations Genitourinary Cancers Symposium Orlando Fla."

"The race to develop a safe and effective vaccine against the Zika virus got one step closer Thursday when a team of researchers reported positive results in the latest round of testing in monkeys. Three experimental vaccines being developed by researchers at Harvards Beth Israel Hospital and the Walter Reed Army Institute of Research had already shown promise in mice but monkeys are a much better model of how the medicines will work in humans. All three of the vaccines were found to be safe and protected the monkeys against infection with the virus according to the report published in Science. The urgency for a vaccine to protect against Zika infection has intensified as the virus spreads rapidly across Latin America and the Caribbean. This week an unprecedented travel advisory was given for southern Florida after more than a dozen people were diagnosed with Zika after being bitten by homegrown mosquitoes. Zika virus is most dangerous to pregnant women because it can cause severe birth defects in babies if they are infected in the womb. Right now just one of those three vaccines will be progressing to clinical trials. That vaccine dubbed ZPIV for purified inactivated Zika virus uses a more traditional vaccine approach and depends on dead virus particles. Striking results To develop the vaccine researchers kill the virus with chemicals leaving behind harmless proteins that the body can learn to recognize as foreign invaders. Using those proteins as targets the immune system can then produce antibodies to latch onto live virus particles and destroy them. This kind of vaccine is much safer than ones that depend on live virus particles to foster immunity. The researchers gave monkeys an initial dose of ZPIV and then a booster four weeks later. Then the monkeys were exposed to active forms of the virus. In tests afterwards the monkeys showed antibodies against Zika and no detectable virus in their blood or urine meaning that the protection from the vaccine was complete. Monkeys that got a sham vaccine developed no antibodies. The results were striking said study coauthor Dr. Dan Barouch a professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School. The findings published today substantially increase our optimism for the potential for the development of a Zika vaccine for humans. Beyond that this is a promising vaccine candidate that can be easily produced in large quantities said coauthor Col. Nelson Michael an Army doctor who specializes in flaviviruses such as Zika and dengue. Testing in people by October To continue the development of the vaccine the researchers will be partnering up with the largest pharmaceutical company solely devoted to vaccines Sanofi Pasteur. The researchers hope to test the vaccine in people by October Barouch said. The two other experimental vaccines described in the new report also sparked an immune response in monkeys. Both of these vaccines depend on new technology in which scientists learn the exact DNA of proteins on the surface of the virus and then create copies to be put in a vaccine. One vaccine had just the manmade proteins in it the other wrapped a common cold virus around the proteins. The proteincold virus vaccine was especially effective sparking a significant immune response after just one dose. Cautiously optimistic Another experimental vaccine developed by researchers at the National Institutes of Health is a bit further along. Trials of that vaccine in people which is also based on manmade copies of virus proteins began on August when the first study volunteer was given a vaccination through a needle free injector said Dr. Anthony Fauci head of the National Institute for Allergy and Infectious Diseases. Results are expected by December and if they are promising a bigger phase II trial will be launched in Zika endemic countries That puts the project ahead of schedule since the original launch of the phase I trials was expected to start in September Fauci said. Still with many years of experience in vaccine development behind him Fauci said youre never overconfident of the clinical results. But we are optimistic that this new DNA Zika is a viable platform Fauci said. So were cautiously optimistic. And if problems turn up there are the three potential vaccine described in the new study. Its always good to have multiple different vaccine candidates in both clinical and preclinical testing Barouch said. That increases the chance that we will have at least one if not more than one that works in the end."

"An experimental approach in which penile nerve tissue is frozen to knock out overactive nerves helped men with premature ejaculation https last three times longer. Researchers tested the technique on men who hadnt been helped by standard treatments. They lasted an average of seconds before ejaculation or nearly two minutes over the three months they were followed compared with seconds before treatment. Thats about what you see with standard drug therapy says researcher J. David Prologo MD assistant professor of interventional radiology at Case Western Reserve Universitys School of Medicine in Cleveland. A time to ejaculation of more than two minutes is normal he tells WebMD. Its supporters say the technique or a similar one involving heat therapy could someday become a standard treatment for the condition. But other experts tell WebMD that questions about the longterm consequences remain. Also unknown whether men would opt for the treatment. The findings were presented here at the annual meeting of the Radiological Society of North America. Prologo consults for Galil Medical which funded the study. Common Sex Problem for Men Premature ejaculation affects to of men making it among the most common forms of male sexual dysfunction worldwide. Treatment options include certain antidepressants https such as Celexa https citalopram https Paxil https paroxetine Prozac https fluoxetine https and Zoloft https sertraline https as well as anesthetic ointments and cream and behavioral therapies. But many men arent helped by the treatments Prologo says. The new technique involves inserting a tiny hollow needle into the skin https near the belly button. Using computerized imaging for guidance the doctor snakes it down to one of the two dorsal penile nerves. Overactivity of these nerves has been implicated as a cause of premature ejaculation. Then we knock out the nerve by freezing it Prologo says. Its not painful though some men feel a cold sensation he says. The procedure takes about minutes and men can go home the same day. While still experimental Prologo estimates the cost at . Repeat Injections May Be Needed After the procedure men were asked five questions relating to their sexual satisfaction. All improved on at least one sexualrelated symptom. There were no side effects from the procedure. However three men reported their erections werent as firm afterward for reasons Prologo cant explain. Unknown is how long the treatment will last. In the third month of the study some men started ejaculating more quickly again. Prologo says repeat injections may be necessary and he is following the men for six months to see what happens. Paula Novelli MD clinical assistant professor of radiology at the University of Michigan in Ann Arbor says that could be a problem. How many times can you repeat it before you do damage she says. Novelli moderated the session at which the findings were presented. Prologo says he doesnt think there will be longterm problems because only one of two nerves is destroyed. Still he is testing a similar but less aggressive technique that uses heat to decrease the activity of overactive penile nerves without destroying them. The researchers plan a study comparing one or both techniques to placebo https in larger numbers of men. These findings were presented at a medical conference. They 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."

"Of course Hologic has done some selling of its own. The firm which markets itself as The Womens Health Company makes other products including a D digital mammography machine a test that assesses risk of preterm labor gynecological products including Adiana a permanent contraception technique and widely used equipment that measures bone density. But D mammography could become its flagship because for the moment it owns the entire market although other companies including powerhouse GE are developing their own D machines Hologic is the only one with FDA approval thus far. Of course given the sluggish economy and the continuing state of uncertainty around American health care persuading hospitals to upgrade may be challenging. So perhaps its not surprising that the companys PowerPoint presentation to the FDA included the unsubtle phrase huge breakthrough or that the first American patient to undergo D mammography Laura Lang a polished yearold Boston marketing executive and breast cancer survivor did so in front of a CBS camera crew last February. Indeed they do. Theyre catching on like well its not a slow burn. The device earned Food and Drug Administration approval on February and for a short time it was available only at MGH. Now it is available in at least nine states three of which have multiple sites and most of the several dozen hospitals around the United States that assisted with clinical trials are planning to buy systems too. The images arent the only selling point. The early data are compelling as well. In studies presented to the FDA radiologists reported a percent improvement in their ability to distinguish cancerous from noncancerous cases when they used the new system. If that sounds unimpressive consider that million women are screened each year any significant reduction in callbacks for additional testing would mean hundreds of thousands of women would be spared painful and expensive followup. Dr. Elizabeth Rafferty is trying not to lapse into rhapsodic cliches. I dont want to call it a magic bullet because that would oversell she says. Its not a panacea. Then five minutes later I dont want to say its catching on like wildfire. After a few minutes more though Rafferty cant help herself. She lets her enthusiasm loose. People have been waiting for it for a long time she says. Its a step but its a step by a person who has a stride of feet. It is a D mammography machine the Selenia Dimensions system one of which sits in the breast imaging clinic at Massachusetts General Hospital that Rafferty a radiologist runs. The machine which is made by the Bedford company Hologic and developed partly at MGH under Raffertys supervision produces images that are so vivid and clear they seem to speak out loud Hey right here This is a tumor If you look at enough of them you may become convinced that you dont need medical training to spot a case of breast cancer or distinguish a false positive on a mammogram from a true one. The distinction seems that clear. If you can tell the difference as a nonradiologist imagine how a radiologist feels says Rafferty. The images sort of sell themselves. Much of the criticism focused on the data the task force had used to make its decision which consisted largely of the results from prospective randomized clinical trials conducted in the United States. Trials like this are the gold standard of medical evidence. They are also expensive and timeconsuming and thus hard to come by. The most recent such trial looking at mammography and mortality in the United States was published in the s. A lot of the people on the task force are my friends and I have tremendous respect for them but this was a big point where we differed says Brawley. The standard type of mammography thats used all over the country today may very well be better than what was used in that trial. So the outcomes may be better too. The studies the task force had chosen to examine showed that screening beginning at age had little impact on mortality while at the same time generating a significant number of false positives. Those data were complete and comprehensive. But says Brawley they were outdated. The task force wasnt expecting a firestorm. That however was what it got. Breast cancer advocacy groups mutinied saying the guidelines would cause significant numbers of women to go undiagnosed for years some of them fatally. Politicians started giving scary speeches about rationing health care. Many radiologists including the MGH department as a whole rejected the new guidelines. Daniel Kopans a world leader in breast imaging he wrote the textbook of that name and a radiologist at MGH now says that the panel didnt understand mammography screening. Furthermore he adds the new guidelines had no biological or scientific reason behind them. The last time someone tried to improve the way American women are screened for breast cancer it turned into a national debacle. In November the US Preventive Services Task Force a governmentbacked group of doctors charged with making recommendations that often influence what insurers will pay for updated its guidelines for mammography. Previously it had advised women to begin annual or biannual screening at . The new guidelines pushed that age to emphasizing that starting earlier should be an individual choice. Debates about mammography are often so emotionally charged that this type of nuance goes missing. I think some of our rhetoric medicines in general and also that of advocates has made people think that every metastatic breast cancer is a failure of the woman to get a mammogram or of a doctor to read a mammogram correctly says Otis Brawley chief medical officer of the American Cancer Society and a professor at Emory Universitys School of Medicine in Atlanta. In reality yes mammography does save lives but it is far from perfect. Its not as good as many people think it is. So if the new D mammography isnt perfect just how good is it But the company and the rest of us should be careful not to overhype D mammography. As Rafferty says its not a panacea. The technology does come with costs financial and medical. A fully equipped D machine runs on average not including the annual service fee Hologic charges for maintenance and even hospitals that already own an upgradeable D system made by Hologic have to pay about to get it adapted for D use. There are also costs in the sense of risks Women who get a combo D and D mammogram the protocol that confers the most dramatic jump in benefits are exposed to twice as much Xray radiation as the norm albeit still an amount thats under the FDAs permitted limit. And no one yet knows if the new technique will actually save lives. Is Hologics D mammography machine likely to fare better There are reasons to think it will. Unlike MRI which requires an injection with contrast dye and an hour in the imaging machine it isnt an ordeal or at least its no worse than a conventional mammogram. Yes you still have to endure the dreaded clamp. And it seems to be more effective than its most similar precursor the D digital technique. Early data from Raffertys trial showed that the same group of women who did benefit from D digital benefited even more dramatically from D. Its worth noting that this is not a small group of people. Fifty percent of women are in what the American Cancer Society considers the intermediate zone of risk which overlaps considerably with the group that saw some benefit in DMIST. Perhaps more important even the women who didnt see any improvement in accuracy with D get a small boost with D over film. And D seems to be both more sensitive and more specific improvement in one area doesnt have to come at the cost of the other. But when the definitive trial of D digital techniques called DMIST was published in tracking nearly patients it didnt provide the answers that advocates had been expecting. Digital mammography did seem to perform more accurately than film in women who were younger than women who were pre or perimenopausal and women with dense breast tissue. But when all women were considered as a group that benefit disappeared. On the whole it turned out digital just didnt live up to the way it had been sold. When D digital mammography was introduced in doctors hoped it would vault over those problems. Well most of them. The cost concern was still present Digital mammography machines were five times as expensive as film ones. The marketing materials suggested it already had. An ad for GEs D digital system that ran during the Summer Olympics called it a major new breakthrough in the fight against breast cancer. Digital technology the thinking went would show nuances that film never could because it could render literally many more shades of gray. The problem however was that each time they introduced a new imaging tool for breast cancer they found that they could not advance on one front without taking a step backward on the other. First there was ultrasound says Rafferty. We did find more cancers but we also found so many false positives that it was untenable. Then there was MRI which had the same problem and it was times more expensive than mammography. Rafferty had already been running trials of D mammography for two years when the task forces guidelines came out. She understood its concern about false positives she was trying to address it herself albeit in a very different way. In fact technology developers had been trying in various ways for years to increase mammographys sensitivity its ability to flag possible cases of cancer while also increasing its specificity its ability to filter out the false positives. Theres an intuitive argument for why D mammography might be more accurate. The technique works a little like a CT scan does it takes pictures of the breast at slightly different angles then fuses them into a single synthesized image. If breast cancers were spherical in shape theyd look basically the same in all images or for that matter on a conventional D picture. But theyre very rarely shaped that way in reality. In the breast in particular cancer cells tend to creep out singlefile along the architecture of the body says Rafferty. And that makes some of them especially hard to see on a D mammogram. They look like distortions not blobs. Theres another thing about cancer that is much clearer on a D mammogram spicules or thin spidery tentacles emerging from the center of a tumor. D images when taken from the wrong angle are often too fuzzy to show them. In D however the spicules are visible in high resolution and seeing them is critical since they are a hallmark of malignancy. To Rafferty the existing data are persuasive enough. I own no stock in Hologic. I have no financial ties to them. And I was skeptical of this idea at first. You think to yourself it is that simple That elegant she says. But this really does address the fundamental flaw of mammography. I want every woman to have access to this technology. I got my sisters down here when it was approved. I was like Youre all going to get this Because in my heart I know its better. Andy Smith Hologics vice president of imaging science is similarly hopeful. Its expected to improve the cancer detection rate. It is going to reduce the recall rate he says referring to suspicious findings that require women to return for followup tests some of which turn out to be false alarms. And we will have more numbers on that within one to two years. This last part at least is very likely true. Mammography is heavily regulated and clinics are required to send their recall statistics the number of women they call back for second looks to the federal government. The data on whether D will save more lives than D may not be known immediately. But they will exist. However the most meaningful data the numbers that would show whether D mammography saves womens lives wont be available for decades. Only a prospective randomized trial with mortality as its endpoint can say for sure and thats how long it takes to conduct one. Smith knows that thats the reality. We are expecting a reduction in morbidity and mortality but we wont know that for a long time he says. You know this technology has only been approved for two months. By the time such data do come out mammography will surely have changed again. There are already efforts to augment it with contrast dyes to develop a complementary tool called a gamma camera and to augment imperfect human judgment by refining computer programs that can spot tumors as well as a radiologist might. What this means is that the next time the US Preventive Services Task Force or anyone else wants to take a hard look at mammography the data it has will once again be outdated. Its inevitable. ThreeD mammography may very well be more accurate than D. It may see more cancers and fewer impostors. But whether its truly a huge breakthrough by the metric that matters most is a question that cant currently be answered and that may be irrelevant by the time it can be. Rafferty may know in her heart that D is better. But right now at least thats the only way she truly can."

"Starting your day off with an egg may help curb your appetite better than cereal new research suggests. In a small study it took longer for people who ate eggs for breakfast https to show signs of hunger https than it did for those who had a bowl of readytoeat cereal. Scientists suspect that egg protein may be better at making people feel full longer compared to the protein found in wheat. For people hoping to shed some pounds changing the type of protein in the diet rather than the amount of it is an idea the researchers think deserves more study as a weight loss strategy. This study shows that diets with higher protein quality may enhance satiety leading to better compliance and success of a weight loss diet https researcher Nikhil Dhurandhar PhD says in a news release. He is an associate professor in the department of infection and obesity https at the Pennington Biomedical Research Center in Baton Rouge La. One large egg has about calories and it contains about grams of protein grams of fat and milligrams of cholesterol https The research was funded by the American Egg Board and will be presented at theth European Congress on Obesity https in Lyon France. Eggs vs. Cereals In the study researchers tracked overweight or obese people giving them either a breakfast https containing eggs or cold cereal for one week. Although the breakfasts offered different protein foods the meals themselves were equally matched in terms of calories carbohydrates protein and fat. Its unclear how the eggs were prepared how many were served or what other foods were included in the breakfast meals. On the first and last day of the test week people were given a buffet lunch to eat. On those days researchers measured how hungry httpsfit.webmd.comkidsfoodrmqrmquizhungerwhatisit or full participants felt before and after breakfast and lunch and they recorded how many calories were consumed at the buffet. They also took blood https samples to determine levels of ghrelin a hungerstimulating hormone and PYY a hormone that signals fullness. Participants then got a twoweek break from the research followed by a second test week where they received the other breakfast food not had during the first week. Researchers found that people who had eggs in the morning felt fuller before lunch and they also ate less food from the buffet compared to those who had cereal. Egg eaters also had lower levels of ghrelin and higher amounts of PYY during the three hours between breakfast and lunch. This suggests they felt less hungry and more satisfied between meals. Longterm weight loss trials to compare the manipulation of protein quality without increasing protein quantity should be explored Dhurandhar says. This study will be 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."

"Montmorency tart cherries may play a role in improving gut health suggests a firstofits kind human trial of nine adults combined with a parallel laboratory study published in the Journal of Nutritional Biochemistry https An international team of scientists found that Montmorency tart cherries helped to positively impact the gut microbiome a collection of trillions of bacteria and other microbes that live in the intestinal tract. The microbiome has been the focus of multiple studies in recent years due to its potential role in maintaining digestive health as well as its impact on immunity heart health blood sugar control weight management and even brain health. The gut microbiome holds great promise especially related to personalized nutrition although the research is still evolving and larger longterm human intervention studies are needed. However the new study does suggest that Montmorency tart cherries can be added to the list of gutfriendly foods. While previous studies on Montmorency tart cherries have ranged from heart health and exercise recovery to sleep this is the first study to explore the potential gut health benefits. The researchers speculate that it may be due to the polyphenols anthocyanins and other flavonoids in Montmorency tart cherries the varietal of tart cherries grown in the U.S. Polyphenols in plantbased foods are broken down by microbes to stimulate growth of good bacteria. Montmorency tart cherries were a logical food to study due to their unique composition of polyphenols including chlorogenic acids said principal investigator Franck Carbonero PhD assistant professor in the Department of Food Science at the University of Arkansas. Our results suggest that the unique polyphenol mixture in tart cherries may help positively shape the gut microbiome which could potentially have farreaching health implications. Research Methodology Researchers conducted both human and laboratory experiments to determine the impact of Montmorency tart cherries on the microbiome. In the human trial nine healthy adults years old drank ounces of Montmorency tart cherry juice from concentrate daily for five days. These individuals were nonsmokers and had not taken antibiotics which can affect the microbiome in the weeks prior and during the study. Using stool samples the participants microbiome was analyzed before and after the dietary intervention and food frequency questionnaires were used to evaluate their overall diet. The laboratory experiments were set up to mimic the conditions within the human digestive system specifically the stomach small intestine and three regions of the colon to study how polyphenols are broken down and absorbed. This process of breakdown and absorption can have a significant impact on the bodys ability to use the beneficial bioactive compounds in plantbased foods. The researchers tested U.S.grown Montmorency tart cherries European tart cherries sweet cherries apricots and isolated polyphenols in each simulated region of the digestive tract. They analyzed changes in the mix of bacteria and how these bacteria helped digest the polyphenols over time. Study Results In the human trial the microbiome was positively altered primarily measured by the increase in good bacteria after just five days of drinking Montmorency tart cherry concentrate although there were strikingly different responses due to the participants initial microbiome composition. Individuals who ate a more Western diet low in fruits vegetables and fiber potentially had a lower ability to metabolize polyphenols thereby reducing bioavailability and any potential health benefits in the tart cherries. Remarkably in these subjects instead of Bifidobacterium Collinsella were the beneficial polyphenoldegrading bacteria stimulated. The individuals who ate a more plantbased diet with higher intakes of carbohydrates and fiber responded with an increase in Bacteroides and Bifidobacterium presumably because of the specific combination of polysaccharides and polyphenols. While more research is needed these results suggest individuals consuming a more plantbased diet may have a mix of gut bacteria that responds more positively andor rapidly to tart cherry consumption. Individuals consuming a more Western diet that is lower in carbohydrates and fiber may have a lowerdifferent ability to metabolize polyphenols thereby altering bioavailability and any potential health benefits. The laboratory experiments found that pure polyphenols characteristics of tart cherries increased the amount of Bifidobacterium. However when concentrated juices were fermented this bifidogenic effect appeared to be leveled out by the larger increase of polysaccharides utilizing bacteria. Somewhat surprisingly Carbonero said chemistry analyses showed that tart cherries polyphenols were not completely converted to smaller phenolic metabolites suggesting that the full diversity of bacterial species in the human gut is required for efficient breakdown of the polyphenols in tart cherries. While the dietary intervention was based on a limited number of human volunteers and more research is needed to support these conclusions the results help build the foundation for future research and suggest Montmorency tart cherries can play a role in positively shaping the microbiome and maintaining gut health. Montmorency tart cherries are the most common variety of tart cherries grown in the U.S. and are available yearround in dried frozen canned and juice forms including juice concentrate which was the form used in this human trial. Montmorency tart cherry juice concentrate can be mixed with water or other juices. It can also be consumed straight from the bottle or used as an ingredient in recipes such as smoothies and other beverages. This study was made available online in April ahead of peerreview and publication this month. Source MaytaApaza AC Pottgen E De Bodt J et al. Impact of tart cherries polyphenols on the human gut microbiota and phenolic metabolites in vitro and in vivo. Journal of Nutritional Biochemistry. . Cherry Marketing Institute The Cherry Marketing Institute a notforprofit organization funded by U.S. tart cherry growers and processors provided financial support for the study. The funders had no role in the study design data collection and analysis decision to publish or preparation of the manuscript. CMIs mission is to increase the demand for Montmorency tart cherries through promotion market expansion product development and research."

"The cancer drug that former president Jimmy Carter says made his melanoma seemingly disappear has helped about percent of similar patients survive for as long as three years oncologists said Wednesday. The drug called Keytruda takes a new approach to treating cancer by stopping tumor cells from cloaking themselves against the normal healthy immune system response. New data about to be released to a meeting of cancer specialists shows that percent of the patients who have been taking the drug are still alive three years later. That compares to about percent of patients given the standard therapy interleukin the American Society for Clinical Oncology ASCO says. That means percent of patients are not living that long but its still far more than the usual month survival with advanced melanoma. It is definitely a huge benefit over what we have seen in the past said ASCO president Dr. Julie Vose a specialist in blood cancers at the University of Nebraska Medical Center. For some of those patients it is likely that their cancer never will come back. Melanoma is the deadliest form of skin cancer. It will be diagnosed in more than Americans this year according to the American Cancer Society and it will kill . Rates are rising in part because tanning became fashionable. Melanoma is easy to cure when caught early but it is often hard to tell if a mole or freckle has turned cancerous. Carter for example was only diagnosed http the tumors had spread to his brain last fall. Thats Stage IV cancer and its almost always deadly at that stage. But Carter has remained well enough to continue teaching his weekly Sunday school classes and said this past Sunday hed just traveled to London. He says theres no trace of his cancer now. In the past patients with this type of melanoma he has metastases to the brain you dont even see responses to therapy Vose told NBC News. This is something really different than what we have seen in the past. Other people are having similar experiences. For the trial Caroline Robert of Gustave Roussy and ParisSud University in France and colleagues treated patients with advanced melanoma. These are patients whose disease cannot be surgically removed cannot be cured by surgery and usually the majority of these patients have disease that involved vital organs said Dr. Stephen Hodi a melanoma specialist at the DanaFarber Cancer Institute who worked on the study. Seventyfive percent of them had already been given other cancer treatments including Yervoy known generically as ipilimumab. On average the patients lived two years and percent of them are still alive three years later. About percent of these patients have whats called a complete remission meaning there is no trace of their tumors. That doesnt mean a cure its too soon to say that but it does mean months or years of cancerfree life that they otherwise could not have hoped for. And of the patients or percent have stopped taking the drug after their tumors went away. Virtually all of them are still in remission. This is huge in the melanoma community said Tim Turnham executive director of the Melanoma Research Foundation. Its difficult to know at what point you call it a cure. For the patient though it means they are cancerfree and for some of those patients it is likely that their cancer never will come back Turnham told NBC News. When this study was started the average life expectancy of someone with advanced melanoma was months and now were seeing that a large percentage of people are living at least three years. Keytruda known generically as pembrolizumab http targets the activity of genes called PD antiprogrammeddeathreceptor and PDL. The interaction between the two genes lets some tumors escape detection and destruction by immune system cells. PD stops immune cells from attacking normal healthy cells by mistake. Tumor cells make PDL turn on PD when immune cells approach. Keytruda an engineered immune protein called a monoclonal antibody disrupts this signal and lets the immune cells attack the tumor cell. The drug works far better in patients whose tumors express more PD meaning they have a lot of PD activity so the drug will optimally be used jointly with a test for PD. There are sideeffects including fatigue itchiness and rash. It was bad enough for percent of patients that they stopped taking it. In a matter of a few years these therapies have truly transformed the outlook for patients with melanoma and many other hardtotreat cancers. The Food and Drug Administration gave Keytruda accelerated approval for melanoma i http . Its got breakthrough therapy designation for Hodgkins lymphoma and colon cancer and got accelerated approval for lung cancer. In a matter of a few years these therapies have truly transformed the outlook for patients with melanoma and many other hardtotreat cancers said Dr. Don Dizon an oncologist at Massachusetts General Hospital and a spokesman for ASCO. Keytrudas being tested in other cancer types now. Earlier Wednesday the FDA gave accelerated approval to a drug that works in a similar way. It approved Tecentriq known generically as atezolizumab for use in patients with advanced bladder cancer. Like Keytruda Tecentriq is a monoclonal antibody. It goes straight to PDL so its target is slightly different. FDAs approval was made on the basis of a trial that showed percent of patients with advanced bladder cancer who had high levels of PDL activity saw their tumors disappear compared to . percent of patients on other treatments. Another percent had a partial response meaning their tumors shrank a little compared to . percent on standard treatment. The drugs must be infused and they are pricey. Keytruda costs about a month or a year."

"In an early study an experimental stem cell procedure helped teens httpsteens.webmd.comdefault.htm with type diabetes httpsdiabetes.webmd.comguidediabetesoverviewfacts stay off of insulin https injections for about . years on average. The study was very small and the procedure is not ready for widespread use. We now have a unique approach with some positive findings but its still early. We need to better understand the biology behind the treatment and follow patients for longterm side effects Robert E. Ratner MD chief scientific and medical officer of the American Diabetes https Association tells WebMD. This is the latest of several stem cell studies to show promising results for the treatment of type diabetes https Ratner notes. In the new study of teens with type diabetes https who got an experimental treatment using their own stem cells https went into remission and did not need insulin https injections for an average of about . years. The cocktail treatment combines stem cell therapy with drugs that suppress the bodys immune system. In type diabetes https the immune system attacks and destroys insulin https cells within the pancreas https The experimental treatment is called autologous nonmyeloablative hematopoietic stem cell transplantation HSCT. It aims to kill the destructive immune system cells and replace them with immature stem cells https not programmed to destroy insulinproducing cells. First patients are given drugs to stimulate production of blood https stem cells. The blood https stem cells are then removed from the body and frozen. Then patients are hospitalized and given drugs to kill the destructive immune system cells. The harvested blood stem cells are then put back into the patient. Eight teens who took part in the study have remained insulinfree for two years on average. One patient has gone without insulin injections for . years. All our patients considered the treatment to be worthwhile and beneficial though some patients experienced side effects study head Weiqiong Gu MD of Ruijin Hospital in Shanghai tells WebMD. As a result of the immunesystem suppressing drugs most of the patients in Gus study experienced side effects including low white blood cell counts fever nausea https vomiting https hair loss https and suppression of bone marrow. Most of those side effects disappeared within two to four weeks and unlike in previous studies of the experimental therapy none of the patients developed infections pneumonia https low sperm https counts or organ damage. One woman became pregnant https by natural means a year after transplantation and delivered a healthy girl Gu says. Still patients have to be followed for years to ensure they do not develop known longterm complications of immunesuppressing drugs including tumors and infertility https Gu says. The findings were presented here at the annual meeting of the American Diabetes https Association and appear in the July issue of the journal Diabetes Care."

"Strobe lighting has been shown to reduce levels of the toxic proteins seen in Alzheimers disease in findings that raise the tantalising possibility of future noninvasive treatments for the disease. The study in mice found that exposure to flickering light stimulated brain waves called gamma oscillations that are known to be disturbed in Alzheimers patients. Boosting this synchronous brain activity appeared to act as a cue for the brains immune cells prompting them to absorb the sticky amyloid proteins that are the most visible hallmarks of the disease in the brains of people with Alzheimers. The authors caution that a big if remains over whether the findings would be replicated in humans and whether cognitive deficits as well as visible symptoms of the disease would be improved. If humans behave similarly to mice in response to this treatment I would say the potential is just enormous because its so noninvasive and its so accessible said LiHuei Tsai director of the Picower Institute for Learning and Memory at MIT and the papers senior author. Alzheimers research has faced a number of major setbacks most recently the failure of Eli Lilys drug trial https after promising results in rodents did not translate into clinical improvements for patients. The latest intervention scientists predict should be quicker and cheaper to confirm in humans than pharmaceuticals which typically take more than a decade to develop and assess for safety before the clinical efficacy is even examined. The study published on Wednesday httpnature.comarticlesdoi.nature in the journal Nature hinges on the observation that Alzheimers patients show a loss of synchronised brain activity known as gamma oscillations which is linked to attention and memory. To restore the activity the scientists first used mice that had been genetically engineered such that the neurons that generate gamma activity in the brain were sensitive to light. The technique known as optogenetics allowed the scientists to artificially cause groups of neurons to fire in unison by pulsing light into the brains of the mice. After an hour of stimulation the researchers found a roughly reduction in the levels of beta amyloid proteins in the hippocampus the brains memory centre. Closer inspection showed that the amyloid had been taken up by microglia the brains immune cells. In a healthy brain microglia act as chemical rubbish collectors surveying the local environment clearing up unwanted compounds but in Alzheimers these cells can lose this function and switch into an inflammatory state in which they secrete toxic compounds instead. Strengthening gamma oscillations appeared to switch the microglia back into a productive state. Next the scientist showed that gamma oscillations could also be stimulated noninvasively in the visual brain region simply by exposing the mice to a flickering light. At Hz the flicker of the light is barely discernible and would be not offensive at all for a person to have in the background. After being given one hour of flickering light each day for a week the scientists saw a reduction of harmful amyloid plaques in the brains of the mice. Ed Mann an associate professor of neuroscience at the University of Oxford said I was surprised and its exciting that such a simple stimulus can target a molecular pathway and have such an effect in an hour. Questions remain however about whether boosting gamma oscillations and sweeping amyloid plaques out of the visual brain region would help with memory which is centred in the hippocampus or broader cognitive abilities. David Reynolds chief scientific officer at Alzheimers Research UK said It is conceivable that changing brain cell rhythms could be a future target for therapies but researchers will need to explore how light flickering approaches could not only reduce amyloid in the visual area of the brain but in those areas more commonly affected in Alzheimers. The authors suggest that it may be possible to take a multisensory approach using a combination of flashing lights and vibrating chairs. Tsai and Ed Boyden a colleague at MIT and coauthor have started a company called Cognito Therapeutics to pursue tests in humans. There are people with dementia in Britain and this figure is expected to reach million by . Earlier this year dementia overtook heart disease https as the leading cause of death in England and Wales."

"Women who want to quit smoking may find it easier if they time their efforts just right. A new study finds hormone fluctuations that occur over the course of a womans menstrual cycle may impact her ability to kick the cigarette habit. According to small study http conducted by researchers at the University of Montreal women are more likely to crave cigarettes and have trouble quitting when in the follicular phase of their monthly cycle. This is the time right after her period and before ovulation. While overall more men than women smoke cigarettes https women and girls take less time to become dependent after initial use and have more difficulties quitting the habit the researchers write in their study. One of the factors contributing to these differences may be that women crave cigarettes more than men and that their desire to smoke is influenced by hormonal fluctuations across the menstrual cycle. The study which was published in Psychiatry Journal involved women and men who were all chronic smokers but otherwise healthy. None of the study participants were enrolled in a smoking cessation program or were trying to quit. Researchers asked each participant to smoke one cigarette to minutes before undergoing an fMRI or brain scan. They were asked to view photos both related and unrelated to smoking. After undergoing the brain scans they viewed the photos a second time and reported on a scale from zero to if the pictures triggered cigarette cravings. The researchers tested of the female participants twice to assess how their response changed at a different point in their menstrual cycle. The brain scans showed that during the follicular stage cigarette imagery activated five areas of the brain which the researchers say are linked to higherlevel cravings. However during the luteal phase after a woman ovulates and before her period only one area of the brain was activated by images of cigarettes and smoking https During the luteal phase estrogen and progesterone levels are at their highest which may help a woman keep addictive cravings at bay and reduce feelings of cigarette withdrawal. Previous studies have found womens monthly hormone fluctuations can affect everything from food cravings and digestive problems to joint pain and a whole host of other health issues. This result emphasizes the need for genderspecific programs to quit smoking https as well as taking into consideration a menstrual cycle phase during addiction treatment in women the researchers conclude. They called for more studies to help understand all the factors that contribute to sex and gender differences in smoking."

"Preliminary experiments in a handful of people suggest that it might be possible to reverse Type diabetes using an inexpensive vaccine to stop the immune system from attacking cells in the pancreas. Research in mice had already shown that the tuberculosis vaccine called BCG prevents T cells from destroying insulinsecreting cells allowing the pancreas to regenerate and begin producing insulin again curing the disease. Now tests with very low doses of the vaccine in humans show transient increases in insulin production researchers will report Sunday at a San Diego meeting of the American Diabetes Assn. The Massachusetts General Hospital team is now gearing up to use higher doses of the vaccine in larger numbers of people in an effort to increase and prolong the response. The findings contradict an essential paradigm of diabetes therapy that once the insulinsecreting beta cells of the pancreas have been destroyed they are gone forever. Because of that belief most research today focuses on using vaccines to prevent the cells destruction in the first place or on using beta cell transplants to replace the destroyed cells. The new findings however hint that even in patients with longstanding diabetes the body retains the potential to restore pancreas function if clinicians can only block the parts of the immune system that are killing the beta cells. The results are fascinating and very promising said immunology expert Dr. Eva Mezey director of the adult stemcell unit at the National Institute of Dental and Craniofacial Research. But Mezey noted that the results had been achieved in only a small number of patients and that they suggest the vaccinations would have to be repeated regularly. The key player in the diabetes study is a protein of the immune system called tumor necrosis factor or TNF. Studies by others have shown that if you increase levels of TNF in the blood it will block other parts of the immune system that attack the body especially the pancreas. To raise TNF levels Dr. Denise Faustman of Massachusetts General Hospital and her colleagues have been working with the BCG vaccine known formally as Bacille CalmetteGuerin. BCG has been used for more than years in relatively low doses to stimulate immunity against tuberculosis. More recently it has been used in much higher doses to treat bladder cancer. Faustman first reported her findings in mice in a paper in the Journal of Clinical Investigation but scientists reviewing her findings for that journal were so skeptical that she was not allowed to refer to regeneration of the pancreas in the paper. Instead she was told to say restoration of insulin secretion by return of blood sugar to normal. In she published a report in the journal Science in which she was able to use the word regeneration but that finding was met by an explosion of skepticism she said. Nonetheless by six international labs had duplicated the mouse experiments she said. We needed to move forward into humans. In the human trial Faustman and her colleagues studied six patients who had been diagnosed with Type diabetes for an average of years. They were randomly selected to receive either two doses of BCG spaced four weeks apart or a placebo. Careful examination of those receiving the vaccine showed a decline of T cells that normally attack the pancreas. It also revealed a temporary but statistically significant elevation of an insulin precursor called Cpeptide an indication that new insulin production was occurring. If this is reproducible and correct it could be a phenomenal finding said Dr. Robert R. Henry of UC San Diego who chaired the scientific program at the meeting. It suggests that once the destructive immune response is controlled the body has the capability to produce more insulin he said. One of the patients receiving a placebo also showed a similar elevation of Cpeptide but that patient coincidentally became infected by EpsteinBarr virus which is known to induce production of TNF. The concentrations of BCG that the team used were much lower than they would have liked but were the highest the Food and Drug Administration would permit Faustman said. She said she is now negotiating with the agency to use higher levels which should produce a more pronounced effect and to enroll more people. The research is funded by philanthropists primarily the Iacocca Family Foundation."

"If you had a history of suffering from migraines and could prevent the debilitating headaches by swallowing a few pills youd do it wouldnt you Actually odds are you wouldnt. Neurologists say that only about onethird of those who could benefit by migrainepreventing medication actually use it. Preventive treatment involves taking a seizure drug and a betablocker every day to reduce the frequency severity and duration of migraines. Neurologists estimate http_ipsecsha that about of people who suffer from migraines stand to benefit with such a regimen and studies suggest that as many as half of migraines can be prevented with drugs according to Dr. Stephen D. Silberstein a neurologist at the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. Silberstein was the lead author of new migraine treatment guidelines http presented Monday at the annual meeting of the American Academy of Neurology in New Orleans. It would seem that migraineurs would be eager to stop these headaches before they start. In a summary of the guidelines http written for patients and their families this is how migraines are described Migraine is a condition that involves recurring headaches. Each headache may last from four hours to two days. It can cause throbbing pain in the head. Other symptoms may include nausea upset stomach vomiting and extreme sensitivity to light or sound. Most people with migraine have attacks that happen repeatedly. Yuck. People whose migraines are infrequent or mild may not be able to prevent them with drugs the guidelines say. But for those who can the best seizure drugs are divalproex sodium Depakote sodium valproate Depakote Depakene Stavzor and topiramate Topamax or Topiragen. Betablockers are usually taken to treat high blood pressure heart arrhythmias and other cardiovascular conditions though metoprolol Lopressor or Toprol propranolol Inderal and timolol Blocadren can also help with migraines. The authors also noted that frovatriptan Frova which is used to treat migraine symptoms can also help prevent menstrual migraines. These medications are effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity Silberstein and colleagues wrote in the new guidelines which were based on a review of publications. In addition an herbal remedy derived from a family of plants called Petasites or butterbur was found to be effective according to the review. The review identified a handful of drugs that are probably effective and should be considered for migraine prevention. These include the antidepressants amitriptyline Elavil Endep or Vanatrip and venlafaxine Effexor the beta blockers atenolol Senormin or Tenormin and nadolol Corgard and for menstrual migraines naratriptan Amerge and zolmitriptan Zomig. People need to keep in mind that all drugs includingoverthecounter drugsand complementary treatments can have side effects or interact with other medications which should be monitored Silberstein said in a statement. Five of the six coauthors of the new guidelines including Silberstein disclosed that they receive research funding speaking fees and other payments from drug companies. The guidelines will be published in Tuesdays edition of the journal Neurology. They were developed in conjunction with the American Headache Society. You can read the new guidelines here http or check out the patientfriendly summary here http Return to the Booster Shots blog."

"Spinal manipulation and home exercise are more effective at relieving neck pain in the long term than medications according to new research. People undergoing spinal manipulation therapy for neck pain also reported greater satisfaction than people receiving medication or doing home exercises. We found that there are some viable treatment options for neck pain said Gert Bronfort vice president of research at the WolfeHarris Center for Clinical Studies at Northwestern Health Sciences University in Bloomington Minn. What we dont really know yet is how to individualize these treatments for each particular patient. All are probably still viable treatment options but what we dont know is what each particular patient will need Bronfort said adding that its possible a combination of treatments might be helpful too. Results of the study are published in the Jan. issue of the Annals of Internal Medicine. Funding for the study was provided by the U.S. National Center for Complementary and Alternative Medicine. Neck pain is an extremely common problem. About threequarters of adults report having neck pain at some point in their lives according to background information in the study. Neck pain is responsible for millions of health care visits each year and it can have a negative impact on quality of life. Spinal manipulation is one type of treatment thats offered for neck pain and it can be administered by chiropractors physical therapists osteopaths and other health care providers according to the study. But there isnt much evidence for treating neck pain with spinal manipulation. There also isnt a great deal of information on how effective medications or home exercise programs are for treating neck pain the researchers noted. Bronfort and colleagues thought that spinal manipulation might prove to be more effective than medications or home exercise therapy. To test their hypothesis they recruited people between the ages of and who had neck pain. Their neck pain had no known cause such as a trauma or pinched nerve and the patients been experiencing the pain for between two and weeks when the study began. The study volunteers were randomly selected for one of three treatment groups. One group received spinal manipulations over a week period. Each individual was allowed to choose the number of spinal manipulations they felt they needed. The second group received medications both over the counter and prescription depending on their needs. Firstline medications included nonsteroidal antiinflammatory medications or acetaminophen Tylenol. If people didnt get relief from these drugs narcotic pain medications and muscle relaxants were offered. The third group was assigned two onehour sessions of home exercise. The goal of the homeexercise program was to improve movement in the neck area. Participants were instructed to do the exercises six to eight times per day. At the th week percent of people receiving spinal manipulation reported at least a percent reduction in pain compared with percent of those on medication and percent doing home exercises. Also at week of people receiving spinal manipulation percent reported feeling a percent reduction in pain compared with percent on medications and percent doing home exercises. At one year percent of those receiving spinal manipulation said they felt a percent reduction in pain versus percent of those on medications and percent of those doing home exercises. For me as an ER doctor this study offers an interesting perspective said Dr. Robert Glatter an attending physician in emergency medicine at Lenox Hill Hospital in New York City. Its a small study but it found that home exercises and spinal manipulation were effective. So should we be referring to physical therapists osteopaths or chiropractors from the ER This study shows that basically neck pain will get better on its own said Dr. Victor Khabie chief of the departments of surgery and sports medicine at Northern Westchester Hospital in Mount Kisco N.Y. It wouldve been good if they had a notreatment group too he added. Everyone heals differently. There are different pathways to healing and whether you feel youre better off with chiropractic home exercises or medications this study shows that all three are basically just as effective. Whatever your pathway to healing in about six to eight weeks you should start to feel better said Khabie. He also noted that its important for anyone receiving spinal manipulation to know that there are rare but serious risks that can occur with neck manipulations. All three experts said anyone experiencing neck pain needs to have it evaluated to make sure there isnt a serious or correctable cause of the pain. This is especially true if youve been in a car accident or if you have any neurological symptoms such as repeatedly dropping things or if you have pain radiating down your arm. More information Learn more about neck pain its causes and treatment from the U.S. National Library of Medicine http SOURCES Gert Bronfort D.C. Ph.D. vice president and professor research WolfeHarris Center for Clinical Studies Northwestern Health Sciences University Bloomington Minn. Robert Glatter M.D. attending physician emergency medicine Lenox Hill Hospital New York City Victor Khabie M.D. codirector Orthopedic and Spine Institute and chief surgery and chief sports medicine Northern Westchester Hospital Mt. Kisco N.Y. Jan. Annals of Internal Medicine"

"Cancer patients undergoing chemotherapy may be able to avoid the accompanying muscle loss and malnutrition by taking fish oil supplements that contain omega fatty acids new research suggests. The finding is based on a small study involving just lung cancer patients. Nevertheless it raises hope that a simple noninvasive intervention might go a long way towards countering the fatigue poorer prognosis and impaired quality of life that can result from chemoinduced muscle mass loss. Fish oil may prevent loss of weight and muscle by interfering with some of the pathways that are altered in advanced cancer study author Dr. Vera Mazurak of the University of Alberta in Edmonton Canada said in a news release. This holds great promise because currently there is no effective treatment for cancerrelated malnutrition. Mazurak and her colleagues report their observations in the Feb. online edition of Cancer. To explore the therapeutic potential of fish oil supplements the authors offered cancer patients undergoing an initial week chemotherapy regimen a daily dose of . grams of a particular omega fatty acid called eicosapentaenoic EPA. While these patients took fish oil supplements throughout their chemotherapy treatment a second group of patients underwent the same regimen minus the fish oil. The results continual muscle and fat measurements revealed that the group that took no fish oil supplementation lost an average of just over pounds the supplement group lost no weight. Whats more blood analyses revealed that those in the fish oil group who had the biggest bump in bloodstream EPA concentrations also had the greatest muscle mass gains. Specifically nearly percent of those in the fish oil group either kept their prechemo muscle mass or gained muscle. By comparison less than percent in the nonsupplement group kept their original muscle mass. Total fat tissue measurements were unaffected by fish oil supplementation the team noted and no side effects were observed. The authors concluded that fish oil supplementation appears to be a safe and effective way to prevent malnutrition among cancer patients and may ultimately prove to be of benefit for other groups of people such as elderly patients who also face a significant ongoing risk for muscle loss. Lona Sandon a registered dietitian and assistant professor of clinical nutrition at the University of Texas Southwestern Dallas reacted with cautious optimism to the findings. Malnutrition is a big concern with cancer patients undergoing chemotherapy and radiation she noted. Because first of all they do have wasting from the cancer itself which is very metabolically active and eats up your energy stores. And then with chemotherapy there is some inflammation thats detrimental to the heart and muscle as it can cause muscle breakdown. And preservation of lean muscle tissue we know leads to better outcomes. So certainly this does seem to be promising Sandon said. And other similar studies have looked at omega and muscle preservation and have also suggested that fish oil can act to prevent inflammation caused by both disease and hardcore medications like chemotherapy agents. But I would caution that the amount of pure concentrated fish oil supplement the people in this study were given is a lot she added. Much much more than any recommended dietary allowance along the lines of two to three servings of fish per week. But she said I would say this is certainly worthy of continuing research and exploration. But meanwhile people should definitely not go out and start consuming huge amounts of fish oil. More information For more on chemotherapy visit the American Cancer Society http SOURCE Cancer Feb. news release Lona Sandon dietitian and assistant professor clinical nutrition University of Texas Southwestern Dallas"

"Postoperative cognitive dysfunction POCD a condition mostly observed in older patients following surgery under general anesthesia is characterized by impaired memory and concentration. The impairment may be temporary or permanent and incapacitating. The problem has become more frequent as the population ages and also as a growing number of older adults undergo surgical procedures made possible by more advanced medical technology. Data from the scientific literature suggest a rise in mortality from POCD in the first year after surgery under general anesthesia. The good news according to a Brazilian study published by the journal PLoS One is that two relatively simple measures can help to reduce the incidence of POCD administering a small dose of the antiinflammatory drug dexamethasone immediately before an operation and avoiding profound anesthesia during the operation. Opinions on the adequate depth of anesthesia and the risks of very profound anesthesia currently diverge. Excessively superficial anesthesia is known to incur a risk of patient recall of the procedure which is undesirable. Our findings confirm recent evidence that the deeper the anesthesiainduced hypnosis the higher the incidence of POCD. The literature points to a link with the systemic inflammatory response induced by surgical trauma damaging the central nervous system. If so the use of an antiinflammatory drug may have a protective effect said Maria Jos Carvalho Carmona a professor of anesthesiology at the University of So Paulos Medical School FMUSP and principal investigator for the study. The researchers evaluated patients aged between and who underwent surgery under propofolinduced general anesthesia at the Central Institute of Hospital das Clnicas FMUSPs teaching hospital in most cases for removal of gallstones. Preoperative assessment included a battery of tests to measure mental and cognitive status. Patients who failed to achieve a cutoff score were excluded. The remaining subjects were divided randomly into four groups. In the operating room deep anesthesia typical of major surgical procedures was induced in the first and third groups and more superficial anesthesia in the second and fourth. Only the third and fourth groups received dexamethasone. The depth of anesthesia was monitored using bispectral index BIS technology which processes electroencephalogram signals to measure druginduced unconsciousness. The researchers classified a BIS of as deep anesthesia and a BIS of as superficial anesthesia. In the fourth group superficial anesthesia with dexamethasone the incidence of POCD was . immediately after surgery but after six months the preoperative cognitive status was restored in all patients. The results reinforce recent evidence of the importance of avoiding deep anesthesia Carmona said. With regard to the use of dexamethasone more research is needed to confirm our finding preferably in multicenter trials but there are strong indications that it can be beneficial in many cases. The earliest trials with patients who developed POCD were performed after the s. Before that older patients were rarely subjected to major surgery and significant research in this field has only been conducted for approximately years. The causes of and risk factors for POCD are still being discussed she said. Little is said about rehabilitation or ways of helping patients recover preoperative cognitive function. One of the obstacles to reliable diagnosis and rehabilitation is a lack of practical and secure instruments for pre and postoperative cognitive assessment. The tests available today are either too time consuming or quick but unreliable Carmona said. This makes it hard to follow up on patients."

"Millions of Americans take baby aspirin every day to prevent a heart attack or stroke. If they are at high risk of heart disease theyre doing the right thing according to draft recommendations http issued Monday by the U.S. Preventive Services Task Force. The independent panel also said that taking lowdose aspirin daily for at least years may protect against colorectal cancer at least in people who are already taking it to prevent heart attacks and stroke. Adults between the ages of and who have a percent or greater risk of having a heart attack or stroke in the next years benefit the most from taking about milligrams of aspirin every day the panel says. But the potential benefit is smaller for adults between the ages of and . And its unknown for adults under or over . People should talk with their health care provider to find out if they have health problems that would justify taking aspirin according to Dr. Douglas Owens httpsmed.stanford.eduprofilesdouglasowens a professor of medicine at Stanford University and a member of the task force. For example uncontrolled high blood pressure or high cholesterol obesity age and diabetes can all increase heart disease risk. Because heart attacks are caused by clots in the arteries of the heart aspirin can help prevent heart attack and it can also help prevent strokes that are caused by blood clots Owens says. Several groups including the American Heart Association offer online calculators http_UCM__Article.jsp to help people figure out their risk which along with discussion with a health care provider can help determine whether daily aspirin might be useful. However there is a caveat. Daily aspirin can cause bleeding in the stomach and brain. And Owens says that people with medical conditions like ulcers kidney problems liver problems or bleeding disorders are more vulnerable as are people who take bloodthinning drugs and NSAIDs. These new recommendations arent final and are open to public comment. Concerns have been raised about whether aspirin is really effective enough when so many other medicines are available to help control heart disease risk. One physician with major concerns is Steven Nissen httpmy.clevelandclinic.orgstaff_directorystaff_displaydoctorid chairman of cardiovascular medicine at the Cleveland Clinic in Cleveland Ohio. I think that millions of Americans are taking aspirin some of them are really the worried well he says. If people dont have a significantly increased risk of having a heart attack or stroke over the next decade Nissen says they may be causing more harm than benefit. And while many medical groups recommend daily aspirin to lower heart disease risk not all federal agencies agree. The Food and Drug Administration actually issued a warning http against routinely taking aspirin to prevent heart disease in people without significantly high risk. Nissen worries that many people are mistaking their actual heart disease risk. With all the good therapies better blood pressure control better cholesterol control all the things we do in modern medicine he says over the last couple of decades weve had nearly a percent reduction in the rate of cardiovascular disease. People who dont really need to should not be taking aspirin every day says Nissen. Its just not prudent or safe he says noting that bleeding in the abdomen or brain is extremely dangerous and can be fatal. Nissen does agree with the general consensus that taking low dose aspirin is beneficial for people who have had a heart attack or stroke. But for pretty much everyone else assessing actual heart disease risk in consultation with your doctor is crucial to deciding whether to take aspirin every day."

"Heart failure patients have weakened hearts but researchers say an experimental drug used for the first time in humans may repair heart cells and improve heart function. According to the results of a small phase trial a single intravenous infusion of the drug cimaglermin was safe and at high doses improved heart function for at least three months. Right now we have many therapies that we use for heart failure and these patients in the study were on all of those therapies and still had significant heart dysfunction said lead researcher Dr. Daniel Lenihan. Hes a professor of medicine and director of Vanderbilt Universitys heart clinical research program in Nashville. People with heart failure often take a combination of drugs Lenihan said. These include medications to lower blood pressure and diuretics to help remove excess fluid that builds up as a result of the hearts labored pumping ability. In addition some people have implanted defibrillators or pacemakers. Even with all these options the death rate among these patients is unacceptably high Lenihan said. Heart failure a condition where the heart cant pump enough blood to meet the bodys needs is among the leading causes of death worldwide. A significant number of heart failure patients dont respond well to current treatments particularly those patients whose left lower heart chamber which pumps blood into the arteries is weak Lenihan said. Cimaglermin acts as a growth factor for the heart helping it repair itself following injury Lenihan said. Specifically it binds to the HER and HER receptors on the surface of heart cells that are important for cellular repair and survival he explained. Researchers have tried using stem cells to repair heart muscle in much the same way he said but these efforts have not been effective. You dont see any sustained effect he added. A phase trial like this one is designed to see if a new drug is safe not to test its effectiveness. Before cimaglermin could be used to treat patients it must prove its worth in a series of progressively larger and challenging trials and then be approved by the U.S. Food and Drug Administration. The process can take several years. Based on these preliminary findings larger trials are being planned Lenihan said. This drug although still in an experimental phase might be an important way to improve heart function in patients with heart failure he said. For the study Lenihan and his colleagues randomly assigned patients to get an infusion of cimaglermin or a placebo. Compared with patients who received a placebo patients given a high dose of cimaglermin had a sustained increase in the hearts ability to pump blood. The improvement lasted days with the maximum increase in heart function reached in days the researchers found. The most common side effects were headache and nausea directly after receiving the drug. One patient who received the highest dose of cimaglermin developed abnormal liver function which cleared up over a twoweek period Lenihan said. The study was funded by Acorda Therapeutics the maker of cimaglermin and the report was published online Dec. in the journal JACC Basic to Translational Science. Dr. Nanette Bishopric is a professor of medicine at the University of Miami Miller School of Medicine and the author of an accompanying journal editorial. There havent been breakthrough treatments for heart failure for a long time she said. Cimaglermin however may be such a drug she said. Its a remarkable thing that you could give a drug once and have it affect heart function three months later its really extraordinary she said. Every drug currently used to treat heart failure has to be given daily or several times a day to get it to work Bishopric said. And when you stop taking it it stops working she said. Despite the encouraging results of this first trial a lot more testing will be needed before cimaglermin can be considered a standard treatment for heart failure Bishopric said. These findings need to be replicated in larger trials and you have to be able to predict whether improved heart function from cimaglermin will help people live longer and feel better she noted. More information For more on heart failure visit the American Heart Association http_UCM__SubHomePage.jsp. SOURCES Daniel J. Lenihan M.D. professor medicine and director heart clinical research program Vanderbilt University Nashville Nanette Bishopric M.D. professor medicine University of Miami Miller School of Medicine Dec. JACC Basic to Translational Science online"

"Women who take part in exercise diet programs or a combination of the two during pregnancy can prevent excessive weight gain according to a fresh review of past research. The review incorporates dozens of new studies to update a previous review that did not find enough evidence to support the use of diet and exercise during pregnancy. After including the new studies the new review found highquality evidence to show diet exercise or both can reduce the risk of excessive weight gain during pregnancy write the researchers in The Cochrane Library. Other benefits may include a lower risk of cesarean delivery excessive birth weight and respiratory problems in the newborn particularly for highrisk women receiving combined diet and exercise interventions add the researchers led by Benja Muktabhant of Khon Kaen University in Thailand. The U.S. Institute of Medicine says the amount of weight women should gain during pregnancy varies depending on their nonpregnancy weight. For example a normalweight woman should gain between and pounds while an overweight woman should gain between and pounds. Obese women should gain even less. Gaining too much weight is tied to an increased risk of complications for both mother and child according to the researchers who completed the review for The Cochrane Collaboration an international organization that evaluates medical research. For the new review the researchers examined data from randomized controlled trials which are considered the gold standard of medical research. They were able to combine data from trials involving a total of pregnant women. The women were randomly assigned to a diet exercise a combination of the two or standard care. The diets and exercise programs varied but could include lowglycemic diets and unsupervised exercise. Women who took part in diet exercise or combination programs were about percent less likely than women in standardcare groups to gain too much weight while pregnant the researchers report. The women who took part in diet exercise and combination programs were also less likely to develop high blood pressure during pregnancy compared to those in the standard care group. There was no clear benefit among the women in the diet and exercise groups when the researchers looked at other complications such as cesarean delivery but it did look like there may be some benefit they write. While the new study generally did not show fewer complications in the diet and exercise group Dr. Loralei Thornburg told Reuters Health that its good that there was no increase in complications. This was very reassuring that there wasnt an increased risk of preterm birth with moderate exercise said Thornburg a highrisk pregnancy expert at the University of Rochester Medical Center in New York. Most people gain more weight than they probably should during pregnancy Thornburg who was not involved with the review told Reuters Health. She said women who gain too much weight may not be able to lose it after the baby is born. Then during the next pregnancy the woman is already heavier and that may increase the risk of complications. In the next pregnancy if you dont get it off you may go from obese to very obese Thornburg said. ADVERTISING She cautioned however that women should check with their doctors before starting a diet and exercise program during pregnancy. SOURCE bit.lyClYDc httpbit.lyClYDc The Cochrane Library online June . Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"

"Patients receiving cancer treatment could increase their chance of survival by up to and help stop their cancer from spreading by taking a lowdose of aspirin new research suggests. In a systematic review of the available scientific literature a team from Cardiff Universitys School of Medicine found a significant reduction in mortality and cancer spread by patients who took a lowlevel dose of aspirin in addition to their cancer treatment average study followup length over years. There is a growing body of evidence that taking aspirin is of significant benefit in reducing some cancers said Professor Peter Elwood who led the research published in the journal PLOS ONE. Whilst we know a lowdose of aspirin has been shown to reduce the incidence of cancer its role in the treatment of cancer remains uncertain. As a result we set out to conduct a systematic search of all the scientific literature. The teams review looked at all of the available data including five randomised trials and forty two observational studies of colorectal breast and prostate cancers. Professor Elwood said Our review based on the available evidence suggests that lowdose aspirin taken by patients with bowel breast or prostate cancer in addition to other treatments is associated with a reduction in deaths of about together with a reduction in the spread of the cancer. The results from six studies of other cancers also suggest a reduction but the numbers of patients were too few to enable confident interpretation. A mutation known as PIKCA was present in about of patients and appeared to explain much of the reduction in colon cancer mortality by aspirin. One of the concerns about taking aspirin remains the potential for intestinal bleeding. Thats why we specifically looked at the available evidence of bleeding and we wrote to all authors asking for further data. In no study was serious or lifethreatening bleeding reported. As a result of the review the team say their study highlights the need for randomised trials to establish the evidence needed to support lowdose aspirin as an effective additional treatment of cancer. Professor Elwood added While there is a desperate need for more detailed research to verify our review and to obtain evidence on less common cancers wed urge patients diagnosed with cancer to speak to their doctor about our findings so they can make an informed decision as to whether or not they should take a lowdose aspirin as part of their cancer treatment. This is not the only significant study Professor Elwood led research examining ways to improve peoples health. In Elwoods team reported the very first randomised trial of aspirin in the prevention of vascular mortality in the British Medical Journal. Professor Elwood also led a major study which monitored the health habits of men over a year period and found that exercise significantly reduces the risk of dementia. The study was the longest of its kind to probe the influence of environmental factors in chronic disease. The study identified five healthy behaviours as being integral to having the best chance of leading a diseasefree lifestyle taking regular exercise nonsmoking a healthy bodyweight a healthy diet and a low alcohol intake."

"A new study bolsters the case that daily aspirin may help protect against cancer although the effect seems weaker than previously thought. An aerial view shows an administration building of the German Bayer AG chemical company in Leverkusen wrapped as giant Aspirin box. And the final chapter on the popular but controversial drug has yet to be written experts say because like earlier research the new work has considerable limitations. News about the cancer potential of aspirin use has been really encouraging lately said Dr. Michael Thun of the American Cancer Society who worked on the study. Things are moving forward but it is still a work in progress. Medical guidelines in the U.S. already urge people to take low doses of aspirin to prevent heart disease if the predicted benefits outweigh the risk of side effects or if they have already suffered a heart attack. Whether those recommendations should be broadened to include cancer prevention is still up in the air however. Earlier this year an analysis of previous clinical trials showed that people on aspirin were less likely to die of cancer than those not on the medication with a percent drop in cancer deaths observed from five years onwards. The new report published Friday in the Journal of the National Cancer Institute is based on reallife observations instead of experiments. It includes a decades worth of data from more than men and women in the U.S. most over and all of them nonsmokers. People who said they took daily aspirin whether baby or adult strength had a percent lower risk of dying from cancer than nonusers overall Thun and his colleagues found. For men the difference came out to fewer cancer deaths a year per people for women the number was . The effect was strongest for gastrointestinal cancers such as colon cancer and stomach cancer. But it didnt seem to matter whether people had been on aspirin for more or less than five years. Because the study wasnt a clinical trial its hard to know if the findings can be chalked up to aspirin or if something else is at play. Still Thun said the results would favor broadening the aspirin guidelines to include cancer prevention based on an individual riskbenefit assessment. But he added that it will take scientists a few years to mull over all of the existing evidence. LONGSTANDING CONTROVERSY Other researchers are more skeptical. Dr. Kausik Ray of St. Georges University of London who has studied aspirin said the new study did not look at overall death rates or side effects such as serious stomach bleeds. This is not a drug without side effects so what you have to look at is net benefit he told Reuters Health. Earlier this year Rays team published an analysis of previous aspirin trials showing the medication did not prevent deaths from heart disease or cancer and was likely to cause more harm than good. One of the problems with the new study as well as with previous aspirin trials he said is something called detection bias. People who develop stomach bleeding from aspirin are likely to get their bowels checked out by a doctor. As a result doctors may find and remove tumors or precancerous polyps which could prolong the patients life the idea behind colon cancer screening. So far most aspirin trials have been designed to test the drugs effect on heart disease. Ray called for trials that specifically check people for new cancers at given intervals to weed out the selection bias marring the previous research. I dont think we have enough hard evidence suggesting everybody should be taking aspirin Ray said. When it comes to cancer the governmentbacked U.S. Preventive Services Task Force agrees. It discourages the use of aspirin to stave off colorectal cancer in people at average risk for the disease. SOURCE Journal of the National Cancer Institute August ."

"A treatment for obesity could be on the horizon as scientists have discovered an antibody that reduces body fat. In trials on mice the antibody was found to increase bone mass and reduce adipose tissue fatand while human studies are some way off the findings could lead to new treatments for weight loss and osteoporosis. The antibody discovered targets folliclestimulating hormone FSH found in the pituitary gland. Ten years ago scientists started looking at the hormones made in the pituitary gland to see how they act on certain targets. They found some of these hormones had an effect on bone mass. From this they created an antibody to see if it could be used to prevent bone loss in miceand in they showed it could. As a result they started considering it as a potential treatment for osteoporosis particularly in postmenopausal womena period when women lose bone mass fairly quickly. But scientists also realized it could have other uses. Mone Zaidi from the Icahn School of Medicine at Mount Sinai New York is one of the authors on the latest study into how the antibody triggers weight loss. Osteoporosis and obesity are fairly closely linked in several ways he tells Newsweek. Women when they undergo menopause lose bone and gain body fat. So we thought maybe there was a connectionthat FSH could have direct effects on adipose tissue. In the study published in Nature httpnature.comarticlesdoi.nature scientists injected the antibody into mice that had had their ovaries removed mimicking menopause and mice that had been fed on a highfat diet. In both cases the antibody caused significant weight loss and gains in bone mass. Zaidi says they looked at the adipose tissue in different areas of the body including under the skin and around the vital organs. In all compartments it was fat reduced by around this level. Its a fairly dramatic effect. Mice also showed increased oxygen consumption higher levels of physical activity and more heat production in beige fat which dissipates energy around the body. But how do mice models translate to human treatments Mice a fairly close genetic match to Humans and Zaidi is hopeful there will be similar effects in humans. Their next step is to humanize the antibody so it can be tested without triggering an immune response. We would then hopefully go to the next phase of preclinical testing which would be to look at side effects toxicology etc. After that we would go into primates and larger animals. That would then leadif all goes wellto the first human trials in three to four years. At present the researchers are focusing on the adiposity rather than bone loss for drug development I think obesity is a more prevalent diseasebut osteoporosis at the tail end can be tagged on. Also to do trials for osteoporosis takes a very long time Zaidi says. Eventually he hopes to end up with an injected drug that gets rid of fat and increases bone mass. Thats the ideal situation he says. It could be a unique obesity drug. But it could also be a unique drug because it lowers body fat and makes bones stronger. And the population that could be most benefited by this could be postmenopausal women. Commenting on the research Tim Speckor Professor of Genetic Epidemiology at Kings College London U.K. says Its a nice mouse study that seems to workwhether it works in humans is another matter."

"Artificial intelligence can be used to spot Alzheimers six years before a patient would normally be diagnosed a study shows. Doctors used the selflearning computer to detect changes in brain scans too subtle for humans to see. The system was able to identify dementia in patients an average of six years before they were formally diagnosed. British AI expert Prof Noel Sharkey from the University of Sheffield said of the findings This is exactly the sort of task that deep learning is cut out for finding highlevel patterns in data. Although the sample sizes and test sets were relatively small the results are so promising that a much larger study would be worthwhile. Boffins from the University of California trained the computer using more than scans from patients. The scans measure brain activity by tracking the uptake of a radioactive liquid injected into the blood. Research has linked the development of Alzheimers to particular changes in certain brain regions but these can be difficult to spot. The Alzheimers algorithm was able to teach itself to recognize patterns in brain scans that indicated disease. As a final test it was given a set of scans from patients it had never studied before. It proved to be percent accurate at detecting Alzheimers disease many years before the patient was later diagnosed. Dr Jae Ho Sohn who worked on the project said We were very pleased with the algorithms performance. It was able to predict every single case that advanced to Alzheimers disease. Early detection of Alzheimers could open the door to new ways of slowing down or even halting the progression of the disease. Dr Carol Routledge from Alzheimers Research UK said The diseases that cause dementia begin in the brain up to years before any symptoms start to show presenting a vital window of opportunity for us to intervene before widespread damage occurs. This study highlights the potential of machine learning to assist with the early detection of diseases like Alzheimers but the findings will need to be confirmed in much larger groups of people before we can properly assess the power of this approach. The research is published in the latest issue of the journal Radiology. Click for more from The Sun. https"

"Millions of people suffer from asthma. Many report having poor control of their symptoms. Fortunately new research shows there is a simple antidote minutes of exercise a day yearround. In a study recently published in BMJ Open Respiratory Research experts from Concordia University the Hpital du SacrCoeur de Montral and several other institutions analyzed the exercise habits of participants who had been diagnosed with asthma. Results were overwhelmingly clear those who engaged in optimal levels of physical activity on a regular basis were nearly twoandahalf times more likely to have good control of their symptoms compared with those who did no exercise. The workout doesnt have to be strenuous. Were not talking about running marathons here says Simon Bacon the studys lead author and a professor in the Department of Exercise Science at Concordia. Just minutes a day of walking riding a bike doing yoga anything active really can result in significant reduction of asthma symptoms. Traditionally people with the condition have been discouraged from exercising because of a belief that it triggers shortness of breath and attacks. Bacon explains that simple precautionary measures can be taken to avoid the discomforts that can be caused by physical activity. The issue of exerciseinduced bronchospasm is real but if you use your releaver medication blue puffer before you exercise and then take the time to cool down afterwards you should be okay he says. Even if you have asthma theres no good reason not to get out there and exercise. Thats a message Bacon hopes resonates. Within his sample group of individuals a whopping reported doing no physical activity. Only said they engaged in the optimal minutes a day. Those numbers reflect the population in general says Bacon who is also director of the Centre de radaptation JeanJacquesGauthier at Hopital du SacrCoeur. Forty per cent of people dont exercise at all he says. We need to keep in mind that doing something is better than nothing and doing more is better than less. Even the smallest amount of activity is beneficial. Its something to keep in mind during winter months when fitness levels tend to drop along with the temperature and cold air provides another trigger for asthma symptoms. Our study shows that those who were able to engage in physical activity on a regular basis yearround benefit most says Bacon. If necessary he suggests finding an indoor place to move whether its the gym a staircase or a shopping mall. Its all about being creative and finding environments where the cold doesnt become an issue. Could a prescription for exercise be the result of this study Bacon is hopeful. It would be great to see physicians recommending physical activity to patients with asthma alongside traditional pharmacological treatments he says. Partners in research Funding support for this study was provided by grants from the Social Sciences and Humanities Research Council Fonds de recherche du Quebec Sante the Canadian Institutes of Health Research and the Michel Auger Foundation of Hopital du SacreCoeur de Montreal. Institutions involved are Hpital du SacrCur de Montral Concordia University Universit de Montreal Universit de Quebec en Outaouais Universit de Montpellier and Universit de Quebec Montreal. Related links Cited study httpbmjopenrespres.bmj.comcontente.abstract Department of Exercise Science https Simon Bacon https Hopital du SacrCur Montral http Media contact Cla Desjardins Senior advisor media relations University Communications Services Concordia University Phone ext. Email clea.desjardinsconcordia.ca mailtoclea.desjardinsconcordia.ca Web http Twitter CleaDesjardins"

"Copenhagen Denmark July Researchers from the Department of Nutrition Exercise and Sports at the University of Copenhagen today announced the findings from a weight loss biomarker study published in the American Journal of Clinical Nutrition AJCN. The study Pretreatment fasting plasma glucose and insulin modify dietary weight loss success results from randomized clinical trials found that fasting blood sugar andor fasting insulin can be used to select the optimal diet and to predict weight loss particularly for people with prediabetes or diabetes. The research analyzed data from three diet clinical trials which collectively looked at more than individuals Diet Obesity and Genes DiOGenes the OPUS Supermarket intervention SHOPUS and the Nutrientgene interactions in human obesity NUGENOB. The findings suggest that for most people with prediabetes a diet rich with vegetables fruits and wholegrains should be recommended for weight loss and could potentially improve diabetes markers. For people with type diabetes the analysis found that a diet rich in healthy fats from plant sources would be effective for achieving weight loss. These diets could also be effective independent of caloric restriction. Two simple biomarkers with a large effect Recognizing fasting plasma glucose as a key biomarker enables a new interpretation of the data from many previous studies which could potentially lead to a breakthrough in personalized nutrition said Arne Astrup M.D. Head of Department of Nutrition Exercise and Sports at University of Copenhagen. The beauty of this concept is its simplicity. While we are looking into other biomarkers it is quite amazing how much more we can do for our patients just by using those two simple biomarkers. We will continue to participate in and support research to explore additional biomarkers such as gut microbiota and genomics approaches which may offer more insights and help to more effectively customize the right diet for specific individuals. The latest findings as reported in AJCN have garnered international support with further analysis conducted by researchers from the University of Colorado Tufts University and Centro de Investigacin Biomdica en Red de Fisiopatologa de la Obesidad y Nutricin CIBER OBN. Presented at the American Diabetes Associations th Scientific Sessions on June the additional research includes an examination of patients in the Prevencion Dieta Mediterranea PREDIMED Study a Randomized Trial of a LowCHO Diet for Obesity CHO Study and The Healthy Weight for Living Study. The different studies six in total employed a variety of nutrition strategies including caloric restriction and ad libitum diets varying the contributions of carbohydrate and fat and increasing fiber intake. The study was inspired by a finding in an early trial of Gelesis a novel hydrogel which demonstrated pronounced weight loss in people with prediabetes. The latest findings as published in AJCN concluded that a personalized nutritional approach based on an individuals biomarkers will lead to improved weight loss and maintenance success. The University of Copenhagen will continue to collaborate with the studys authors and other experts to advance this research and help find solutions for people around the world who struggle with weight loss. About the University of Copenhagen With over students and more than employees the University of Copenhagen is the largest institution of research and education in Denmark. The purpose of the University to quote the University Statute is to conduct research and provide further education to the highest academic level. Approximately one hundred different institutes departments laboratories centres museums etc. form the nucleus of the University. The Department of Nutrition Exercise and Sports conducts research education innovation and dissemination of information in nutrition human physiology and sports at the highest international level and incorporates the humanities as well as health and social sciences."

"A simple blood test may one day offer a safe way to detect Down syndrome during pregnancy researchers say. In a small study an experimental blood test identified a gene mutation associated with Down syndrome with percent accuracy according to the Cyprus scientists. Down syndrome is a common birth defect with one Down syndrome birth in every births in all populations said lead researcher Philippos Patsalis chief executive medical director of the Cyprus Institute of Neurology and Genetics in Nicosia. This is due to an extra chromosome and that leads to physical and mental impairment. With our method we identify all normal and all Down syndrome pregnancies Patsalis said. Currently Down syndrome is diagnosed using one of two invasive procedures amniocentesis or chorionic villus sampling. Because these tests while percent accurate carry a percent to percent risk of miscarriage only about one in pregnant women opts for them he said. The new test eliminates the risk of miscarriage Patsalis said. It also can identify Down syndrome in the th week of pregnancy early enough for a woman to end her pregnancy if she chooses Patsalis said. Although Down syndrome varies in severity it usually causes some intellectual impairment and distinguishing facial features. Heart defects and other health problems are also common according to the March of Dimes. Older mothers are more likely to give birth to Down syndrome babies. People with Down syndrome also known as Trisomy carry three copies of chromosome instead of two. For the study published online March in Nature Medicine Patsalis and his colleagues took blood samples from pregnant women and mothers of Down syndrome and healthy babies. In each case the test quickly pinpointed the chromosomal variation identifying Down syndrome cases and normal fetuses the study authors said. If larger clinical trials confirm the results the test could become standard practice Patsalis said. The cost is much lower than the invasive procedures he said. We estimate we can introduce this to clinical practice in a couple of years. Dr. Brian Skotko clinical fellow in genetics at Childrens Hospital Boston and a spokesman for the National Down Syndrome Society said this study has widespread implications for the incidence of Down syndrome. With this new test women will know if their baby has Down syndrome even before they look pregnant Skotko said. So they will be able to make a very personal decision without anyone realizing it he said. Noting that most of his Down syndrome patients say they lead fulfilling lives Skotko said The overwhelming majority of family members say they cant imagine their life without their family member with Down syndrome. More information For more information on Down syndrome visit the U.S. National Library of Medicine http SOURCES Philippos Patsalis Ph.D. chief executive medical director The Cyprus Institute of Neurology and Genetics Nicosia Brian Skotko M.D. clinical fellow in genetics Childrens Hospital Boston spokesman National Down Syndrome Society March Nature Medicine online"

"In a bid to make cancer immunotherapy more effective researchers report they have succeeded in halting the progress of aggressive melanoma in its tracks at least briefly in seven patients treated with an army of cloned cancerfighting immune cells. In one of those patients the treatment resulted in complete remission of his metastatic melanoma and evidence that his immune system stands ready to fight any return of the cancer after three years. The study published Monday in the Proceedings of the National Academies of Science contributes to hopes that a tumorfighting strategy called immunotherapy can slow halt or even reverse the growth of a range of cancers and do so with fewer dangerous side effects. Immunotherapy is one of medicines most promising and most problematic approaches to cancer treatment. It aims to charge up the patients immune system to attack cancer cells and halt their outofcontrol growth. The approach outlined in the new study by researchers from the Fred Hutchinson Cancer Research Center in Seattle identifies several ways to make it better said Dr. Cassian Yee the studys senior author. The key is to identify specific cancerfighting cells already circulating in the blood of patients and make thousands of copies of them in the lab. This type of adoptive immunotherapy could be effective against a wide range of cancers Yee said. His research group is making plans to try the technique on patients with advanced ovarian cancer and sarcomas rare tumors that arise from connective tissue in bones and muscle. Several independent researchers said the study results were promising. But they also noted that the trial involved only patients and said the therapy was less effective than in other published trials. Someday cellbased therapy will be mainstream in cancer therapy said Dr. Jeff Miller of the University of Minnesotas cell therapy core laboratory. Each article that shows clinical activity is giving us a piece of the puzzle that will make it safer and more effective he said. Immunotherapy usually starts with clinicians harvesting immune system cells called T cells that have attached themselves to a tumor in an effort to attack. They then coax the cells to multiply either in the lab or in the body and let them loose in the bloodstream so they can attack cancer wherever they find it. Yees team tried to do this more precisely. The researchers hoped that by choosing T cells more selectively and cloning only those judged most likely to vanquish their foe the treatment would be more effective. Sorting through the bodys vast and diverse population of T cells to select just the right ones is a painstaking process. But Yee bet that the extra effort would pay off with better results and fewer side effects. Researchers drew blood from patients and scoured it to find the rare type of immune cell a melanomaspecific cytotoxic T lymphocyte cell that specifically homes in on proteins expressed by the cancer. Then they put their harvest as few as a few hundred cells into a test tube and cloned them creating millions. The last step was to infuse the resulting army of cancerfighting clones back into the patient. In six of the patients in the trial the melanoma stopped progressing for to weeks. Another patient was declared in remission because his cancer ceased to spread and after several months disappeared altogether. Three years later researchers continue to detect the presence of the cloned cells they infused into the patient yearold high school history teacher Gardiner Vinnedge of North Bend Wash. For six years Vinnedge endured painful rounds of chemotherapy only to have his melanoma return. The immunotherapy allowed him to return to work three weeks after treatments began. The only side effect he said was a raging rash that lasted for three days. My back my legs were just covered with a hot red rash Vinnedge said. It meant the treatment was working the war was on between my T cells and the melanin in my skin. Now he says he is optimistic he may live to see retirement age though hes not sure hell ever stop teaching. For immunotherapy to work the manufactured T cells must survive for the months it takes to reach a tumor and dismantle it as well as to round up migrating cancer cells and kill them. Currently the T cells have limited staying power and often die off before their work is done. Doctors give them a boost by administering a growth factor called interleukin. But at high doses it can cause dangerously low blood pressure breathing problems kidney failure and heart arrhythmias. Yees group showed that by choosing T cells more selectively patients can get by with much lower doses of interleukin making the treatment less toxic. The researchers also discovered another way to reduce their dependence on interleukin by selecting the most youthful T cells which survived the longest when infused into patients. Dr. Patrick Hwu of the MD Anderson Cancer Center in Houston said the study adds to the wealth of what we know about using the bodys immune system to fight cancer. But immunotherapy pioneer Dr. Steven A. Rosenberg was highly critical of the methods and results. Cloned cells dont work said Rosenberg who heads the National Cancer Institutes tumor immunology section. In larger immunotherapy trials that used cultured cancerfighting immune cells taken from patients tumors Rosenberg and his colleagues achieved durable and complete regression in as many as as patients with advanced metastatic melanoma. These results he said are inferior."

"Taking nonsteroidal antiinflammatory drugs NSAIDs which include medicine cabinet staples such as aspirin Motrin and Aleve appears to significantly lower the risk for developing several major forms of skin cancer a new Danish study reveals. Whats more the apparent protective impact of both prescription and nonprescription NSAIDs on skin cancer risk seems to be stronger the longer someone takes them. Overthecounter NSAIDs are used to control pain fever and swelling. NSAIDs also include prescription medicines called COX enzyme inhibitors such as Celebrex celecoxib. Our study showed that users of common painkillers known as NSAIDs have a lower risk of the three major types of skin cancer including malignant melanoma basal cell carcinoma and squamous cell carcinoma said study lead author Sigrun Alba Johannesdottir at the department of clinical epidemiology at Aarhus University Hospital in Aarhus Denmark. The greatest effect she noted was found for squamous cell carcinomas and malignant melanoma especially when these painkillers were taken frequently and over a long time period. The study appears in the May online issue of the journal Cancer. The authors noted that prior work supported the notion that NSAIDs may offer some measure of protection against cancer most notably colorectal cancer by specifically impeding the cancercausing activities of COX cyclooxygenase enzymes. However the team suggested that past investigations into how NSAIDs may affect skin cancer risk in particular had key design problems that undercut efforts to nail down any NSAIDskin cancer connection. For the new study the researchers analyzed prescription databases and health information registries including the Danish Cancer Registry and the Danish Civil Registration System. The team focused on diagnostic and death records concerning nearly cases of squamous cell carcinoma about cases of basal cell carcinoma and nearly cases of malignant melanoma diagnosed between and when the patients were at least years old. In turn prescription histories were gathered for both the cancer patient group and almost healthy Danes. Records covered the use of both low and highdose aspirin ranging from milligrams to milligrams socalled nonselective NSAIDs such as ibuprofen Advil and naproxen Aleve and both older and newer types of COX inhibitors. Researchers noted the number of prescriptions issued per patient and their length of use with shortterm use defined as fewer than seven years. The result The relative risk for squamous cell carcinoma was found to have dropped by percent among those Danes who had filled more than two NSAID prescriptions compared to those who had filled two or less. Similarly malignant melanoma risk fell by nearly as much percent among those filling more than two NSAID prescriptions. However the same dynamic was generally not seen with regards to basal cell carcinoma. But taking NSAIDs for long periods of time and at relatively high doses was associated with a reduced risk between and percent specifically for basal cell cases that manifested in skin regions that typically experience relatively little sun exposure areas other than the neck or head. On that front longterm users and those who took NSAIDs at relatively higher doses appeared to benefit from the strongest protective effect suggesting that when it comes to skin cancer risk reduction more NSAID use is better. The researchers pointed out that the NSAIDcancer connection could be affected by a range of lifestyle factors they did not account for such as an individuals specific skin type or sun exposure patterns. But Johannesdottir added that we hope that our finding will inspire more research on skin cancer prevention. Also the potential cancerprotective effect should be taken into account when discussing benefits and harms of NSAID use she noted. However other studies need to detail the association further and to examine benefits versus risks she cautioned. Meanwhile the most important prevention against skin cancer remains sun protection. Meanwhile Dr. William Ting a private practice dermatologist in San Ramon Calif. praised the study despite agreeing that many factors are at play when it comes to skin cancer formation. Now we have a better understanding that inflammation also plays a significant role in cancer formation and even skin cancers he said. And this exciting article gives physicians and consumers a relatively simple way of diminishing ones risk of skin cancer by doing what most of us are doing already for heart health Ting added. Ting also advised that people consult with their doctor before starting on any blood thinner. While the study found an association between skin cancer risk and NSAIDs it did not prove a causeandeffect relationship. More information For more on NSAIDs and cancer visit the U.S. National Cancer Institute. SOURCES Sigrun Alba Johannesdottir department of clinical epidemiology Aarhus University Hospital Aarhus Denmark William Ting M.D. F.A.A.D. private practice dermatologist Advanced Dermatology Care San Ramon Calif. May Cancer online"

"About people in the United States suffer from a stroke each year. Of those who survive about percent will be left disabled making the cardiac event a major cause of adult disability. While there are therapies to help improve patients mobility theyre only effective within the first few hours of an event. Recently researchers from the Stanford University School of Medicine have made it their mission to improve these outcomes. They hypothesized that injecting stem cells into the brains of chronic stroke patients would increase their survival rates. And in a clinical trial testing the technique researchers found injections can safely improve patients motor function. What surprised us most was the remarkable recovery some patients had Dr. Gary Steinberg professor and chair of neurosurgery at Stanford told Medical Daily While we had hoped for that we didnt really expect it. Patients recover from strokes over the first six months and then theres very little recovery after that. You know they go to rehab and theres not much more more they can recover usually. For the study Steinberg and his team recruited patients who had suffered their first and only stroke six months to three years prior to the trial. Each patient had a small hole drilled through their skulls in order for researchers to be able to inject stem cells taken from the bone marrow of two donors directly into parts of their brains that were damaged from stroke. After patients were sent home researchers continued to monitor their health through blood tests clinical evaluations and brain imaging. Results showed that the implanted stem cells didnt survive very long in the brain disappearing about one to two months after injections however patients still showed significant motor recovery at six and months postsurgery. Some of the patients bound to wheelchairs were even able to walk again. The recovery some patients showed was not just minimal it was significant said Steinberg who has researched stem cell therapies for more than years. It wasnt just someone who couldnt move their thumb now being able to move their thumb it was more profound than that. The types of stem cells used called mesenchymal stem cells can differentiate into a variety of cell types. In other words they are the precursors to muscle fat bone and tendon tissue. Past research http has shown that these cells can be used to treat the effects of hypoxicischemic encephalopathy brain damage caused by loss of oxygen. In Steinbergs study it did not cause problems by differentiating into unwanted tissues or forming tumors. And even when the stem cells came from an unrelated donor the participants did not experience a strong immune reaction. Although more than percent of patients reported suffering headaches afterward the researchers said it was probably due to the surgical procedure rather than the stem cells themselves. Furthermore there were no lifethreatening effects linked to the procedure used to administer them. Motor improvement was also independent of the severity of the stroke patients conditions an important detail considering older adults tend to respond less to treatment the researchers said. In addition to setting the stage for an expanded trial of the procedure the promising results also change our notion of what happens after a stroke Steinberg explained. The findings suggest that strokedamaged areas of the brain once thought to be dead or irreversible can actually be resurrected. Source Steinberg G Kondziolka D Wechsler L et al. Clinical Outcomes of Transplanted Modified Bone MarrowDerived Mesenchymal Stem Cells in Stroke A Phase a Study. Stroke. ."

"A phase study of children ages years with attention deficithyperactivity disorder ADHD has shown that a delayedrelease longacting formulation of the stimulant methylphenidate when taken in the evening led to significant improvement in ADHD symptoms and functional impairment first thing the next morning compared to a placebo. Children taking the delayedrelease stimulant did not have to wait for a morning dose to take effect and also benefited from improved symptoms later in the afternoon and evening according to the study results published in Journal of Child and Adolescent Psychopharmacology a peerreviewed journal from Mary Ann Liebert Inc. publishers. The article is available free on the Journal of Child and Adolescent Psychopharmacology website. The article entitled Efficacy and Safety of HLD DelayedRelease and ExtendedRelease Methylphenidate in Children with AttentionDeficitHyperactivity Disorder httponline.liebertpub.comdoifull.cap.. is coauthored by Steven Pliszka MD from The University of Texas Health Science Center at San Antonio and colleagues from Massachusetts General Hospital Boston MA Westside Medical Family Practice Clinton UT University of Tennessee Health Science Center Memphis TN Meridien Research Maitland and Bradenton FL Childrens Development Center Winter Park FL Ironshore Pharmaceuticals Development Grand Cayman Cayman Islands and Mount Sinai Medical Center New York NY on behalf of the HLD Study Group. The drug formulation which consists of two layers of microbeads with an inner drugloaded core delays release of the active ingredient for hours and then provides controlled extended release designed to cover the early morning into the evening. The medication was well tolerated with the main adverse effects of appetite suppression and insomnia being those commonly reported for other formulations of methylphenidate. Developing new formulations of effective medications for patients with ADHD improves the lives of children with the disorder says Harold S. Koplewicz MD EditorinChief of the Journal of Child and Adolescent Psychopharmacology and President of the Child Mind Institute in New York. About the Journal Journal of Child and Adolescent Psychopharmacology is an authoritative peerreviewed journal published bimonthly in print and online. The Journal is dedicated to child and adolescent psychiatry and behavioral pediatrics covering clinical and biological aspects of child and adolescent psychopharmacology and developmental neurobiology. Complete tables of content and a sample issue may be viewed on the Journal of Child and Adolescent Psychopharmacology website http About the Publisher Mary Ann Liebert Inc. publishers is a privately held fully integrated media company known for establishing authoritative peerreviewed journals in many promising areas of science and biomedical research including Cyberpsychology Behavior and Social Networking Games for Health Journal and Violence and Gender. Its biotechnology trade magazine GEN Genetic Engineering Biotechnology News was the first in its field and is today the industrys most widely read publication worldwide. A complete list of the firms journals books and newsmagazines is available on the Mary Ann Liebert Inc. publishers website http"

"Among nonsmokers who had diabetes those who took the diabetes drug metformin had a decrease in lung cancer risk according to a study in Cancer Prevention Research a journal of the American Association for Cancer Research by Lori Sakoda PhD MPH research scientist at the Kaiser Permanente Division of Research in Oakland California. Some laboratory studies and a number of observational studies suggest that metformin may prevent cancer but the data from human studies however are conflicting explained Sakoda. The researchers conducted this study to further clarify the association between metformin use and lung cancer risk. Sakoda and colleagues conducted a retrospective cohort study of diabetic patients percent men years or older who completed a healthrelated survey between and . Information on their diabetes medications was collected from electronic pharmacy records. About percent of them were everusers of metformin defined as those who filled two or more prescriptions within a sixmonth period. During years of followup patients were diagnosed with lung cancer. Of them were nonsmokers and were current smokers. Metformin use was not associated with lower lung cancer risk overall however the risk was percent lower among diabetic patients who had never smoked and the risk appeared to decrease with longer use. Nonsmokers who used metformin for five years or longer had a percent reduction in lung cancer risk but this finding was not statistically significant. Metformin use for five or more years was associated with a percent decrease in the risk for adenocarcinoma the most common type of lung cancer diagnosed in nonsmokers and an percent increase in the risk for smallcell carcinoma a type of lung cancer often diagnosed in smokers but neither of these findings were statistically significant. In an interview Sakoda said Metformin use was not associated with lung cancer risk when we looked at all patients with diabetes. However our results suggest that risk might differ by smoking history with metformin decreasing risk among nonsmokers and increasing risk among current smokers. Our results suggesting that the risk associated with metformin might differ by smoking history were unexpected. Additional large wellconducted studies are needed to clarify whether metformin may be used to prevent lung or other cancers particularly in specific subpopulations such as nonsmokers. This study was funded by the National Institutes of Health. Sakoda declares no conflicts of interest. Assiamira Ferrara Charles Quesenberry Jr. and Laurel Habel coauthors on this study have received research funding from Takeda to Kaiser Foundation Research Institute for a study of pioglitazone and cancer and from Sanofi through a subcontract from University of North Carolina to Kaiser Foundation Research Institute for a study of insulin glargine and cancer. Habel has received additional research funding from Genentech to Kaiser Foundation Research Institute for a study of HERpositive breast cancer including risk of cardiotoxicity following trastuzumab. Follow us Cancer Research Catalyst httpblog.aacr.org Twitter AACR and Facebook http For AACR information visit Fast Facts About the American Association for Cancer Research Founded in the American Association for Cancer Research AACR is the worlds oldest and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than laboratory translational and clinical researchers population scientists other health care professionals and cancer advocates residing in countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention biology diagnosis and treatment of cancer by annually convening more than conferences and educational workshops the largest of which is the AACR Annual Meeting with over attendees. In addition the AACR publishes eight peerreviewed scientific journals and a magazine for cancer survivors patients and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer the AACR provides expert peer review grants administration and scientific oversight of team science and individual grants in cancer research that have the potential for nearterm patient benefit. The AACR actively communicates with legislators and policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR visit http"

"When Kelly Hidleburgs confounding case of anemia was traced to heavy bleeding due to uterine fibroids she faced the same tough choice that confronts thousands of American women every year. She could have her uterus or just the fibroids surgically removed or she could try one of several newer procedures aimed at shrinking the usually benign but troublesome tumors. At she could try waiting a few years to see whether menopause with its natural decline in hormones would solve the problem. Hidleburgs options were even more limited however because she didnt want to have surgery with a long recovery time that would take her away from work and family. And even with iron supplements her anemia was so severe that waiting out the fibroids wasnt looking good either. But then her gynecologist Minda Green suggested another option a new tool that requires no incision and uses heat to damage the fibroids which then shrink. Though the tool is still being tested what Hidleburg heard sounded too good to pass up. With this option I had a better chance of recovery and going back to work more quickly said Hidleburg who lives in Olney. Last month the mother of two grown children underwent the outpatient procedure at Hahnemann Hospital without a hitch and returned home the same day. A few days later she was back at work as a Philadelphia correctional officer. Sonata which stands for sonographyguided transcervical ablation a device made by Californiabased Gynesonics shows promise as an addition to the arsenal of ways to treat a condition that is common but that has defied easy solutions. This is probably the most minimally invasive surgical procedure you can do said Green an assistant professor in Drexel Universitys College of Medicine who is coinvestigator in the devices trial at Drexelaffiliated Hahnemann. Thats hugely important. . . . You can get back to work and life. Thats what women want. Sonata uses a probe that is inserted through the cervix into the uterus. The probe not only allows the doctor to see the fibroid using ultrasound but it also has a radiofrequency device at the tip. The doctor hits a foot pedal to send energy through the probe to heat the fibroid shrinking it over time. The body absorbs the dead tissue so it does not have to be surgically removed. The tool is also being tested at other sites in the United States including Cooper University Hospital and Christiana Care Health System. Fibroids are muscular tumors usually benign that grow in the wall of the uterus. They can affect up to percent of women by the time they reach age but in most cases the fibroids cause no symptoms. Sometimes symptoms are mild enough that women can be treated with hormone therapy or can wait them out until menopause. But for some women significant fibroids can mean profuse bleeding cramping and pain from the pressure they can exert. They also can pose problems during childbirth and in rare cases can even affect fertility. An estimated onefourth of all women with fibroids require treatment according to the National Uterine Fibroids Foundation. Hidleburg lost so much blood during her heavy menstrual cycles that she was extremely anemic. Of her five fibroids four were deep in the uterine wall. The options Hundreds of thousands of hysterectomies are performed each year in the U.S. mostly to treat uterine fibroids making the procedure the most common choice. But this is major surgery that can mean a lengthy recovery time increasing demand for alternatives from hormone therapy to more complicated procedures. Though hysterectomies are not performed as frequently as they once were their rates are widely considered to be too high. Another option is to have just the fibroids removed a procedure known as myomectomy. But that also is an invasive procedure requiring an incision and longer recovery time. And unlike a hysterectomy there is no guarantee that fibroids wont grow back after myomectomy. Power morcellation a technique that cuts up the uterus or just the fibroids for removal through tiny incisions seemed to be the answer for some promising swifter recovery times than the traditional open hysterectomy. But in some cases the FDA estimates one in the device disseminates an undiagnosed cancer that preoperative screening tests cannot reliably detect. The FDA has advised physicians and hospitals not to use it except in rare cases. Sonata is not the first procedure aimed at shrinking fibroids without surgery though it is touted as less invasive. In uterine artery embolization UAE an interventional radiologist uses a catheter in the groin to deliver small particles that block blood flow to the fibroids. But some women including Hidleburg turn it down because it can be painful while the fibroids shrink. Other options include Acessa a therapy which employs laparoscopic radiofrequency waves to destroy the tissue. Also tested at Hahnemann it was approved in and heats the fibroid but requires two small incisions and uses multiple tools unlike the allinone Sonata probe. ExAblate is an MRIguided technology that uses magnetically focused energy to eliminate the tissue. It can take hours and shrinks fibroids less than percent studies indicate. While the list of options looks long each has its drawbacks according to gynecologists. The market is not overcrowded by any means says Erin Carey an assistant professor at the University of North CarolinaChapel Hill and division director of minimally invasive gynecology surgery who is not involved in the Sonata trial. Theres huge room for growth. Dipak Delvadia a Drexel assistant professor of obgyn who is a principal investigator for the trial said it was appropriate for fibroids in the uterine wall that are between and centimeters. Weve been trying to get to these types of fibroids and tumors for a long time in a minimally invasive way he said. In the OR During the procedure Hidleburg was under general anesthesia though Sonata can be used in an office setting with partial sedation according to Gynesonics. Green who under Delvadias supervision was performing the procedure for the first time guided the probe through the cervix to the uterus where she could see a clear D image of the fibroids. Then Green deployed the electrodes which reach degrees Fahrenheit being careful to ablate or heat as much of the fibroid as possible without harming surrounding tissue. The system calibrates how long the ablation will take depending on the fibroids location and characteristics. Hidleburgs first fibroid required minutes and seconds. Then Green was on to treat the next one. Compared with the Acessa procedure which requires the physician to manipulate multiple devices Sonata is much easier Green said afterward. She also noted that the procedure doesnt require a radiologist. Sonata was approved in Europe a few years ago and has been getting positive reviews so far here. But because its still under investigation in the U.S. its not covered by insurance patients such as Hidleburg who participate in a trial are treated for free. If insurance doesnt pay for Sonata no one is going to get it said Jay Goldberg a professor at Einstein Medical Center and director of its Philadelphia Fibroid Center. He notes that ExAblate which typically isnt covered by insurance can cost tens of thousands of dollars out of pocket one reason it is not often used. Sonatas manufacturer declined to say what the procedure might cost once the trials are complete and it is approved. The company has said one advantage of Sonata is that it is simpler to perform putting it within reach of more doctors. But Goldberg notes that such minimally invasive procedures require a lot of skill to perform safely. You need a really experienced surgeon he says. Will it translate to the average obgyn Fibroids rarely are malignant but UNCs Carey noted that because tissue is not removed with the Sonata method it cannot be biopsied to be certain. Carey also wants to know more about Sonatas potential impact on fertility. The trial targets women who do not want future pregnancies so that question will not be put to rest in the trial although the procedure anecdotally does not appear to hurt fertility according to Gynesonics medical director David Toub. If confirmed through additional studies that it doesnt affect fertility Carey says that would make Sonata a gamechanger. This is what would elevate the product. Meanwhile Hidleburg is happy with her choice which she said was painfree and allowed her to get back to her routine quickly. Everything went well she says. It was in and out."

"The U.S. Food and Drug Administration FDA said it had approved Adamas Pharmaceuticals Incs treatment for a side effect caused by a commonly prescribed Parkinsons drug sending the shares of the drugmaker soaring in aftermarket trading. The companys shares were up . percent at . after the bell on Thursday. A majority of patients diagnosed with Parkinsons are treated with levodopa whose use often leads to dyskinesia involuntary movements that are nonrhythmic purposeless and unpredictable. Parkinsons disease is a debilitating disorder in which brain cells progressively die causing patients to experience tremors rigidity extreme slowness of movement impaired balance and difficulties in swallowing and speaking. Adamas Gocovri previously ADS is the first drug cleared by the FDA to control levodopainduced dyskinesia LID. The longacting therapy is taken oncedaily at bedtime. An estimated percent of levodopatreated patients about people in the United States suffer from LID the company said. Fluctuating levels of levodopa result in erratic periods of muscular control and involuntary movements throughout the day disrupting activity at least half a dozen times a day. As Parkinsons progresses patients are dyskinetic just after taking levodopa but increasingly exhibit off time or worsening symptoms as it wears off. These patients have little recourse other than opting for deep brain stimulation a surgical procedure that involves blocking electrical signals from targeted areas in the brain. With Gocovri which targets both dyskinesia and off time patients will be able to reclaim about . hours of their day CEO Gregory Went said in an interview ahead of the decision. About people are diagnosed with Parkinsons in the United States each year according to the National Institutes of Health. The main ingredient of Gocovri amantadine has been available in the market as an antiviral drug for several decades. The company said the drug is expected to be available in the fourth quarter and formally launched in January . Adamas is also testing the drug to treat walking impairment in patients with multiple sclerosis."

"Study in adults with treatmentresistant depression marks the first time an antidepressant has achieved superiority in a clinical trial for major depressive disorder that included a newly initiated oral antidepressant in both the control and placebo groups Study in elderly patients is the first large clinical trial in treatmentresistant depression in this population Results demonstrate the potential of esketamine nasal spray to address a significant unmet need for the more than percent of people suffering from major depressive disorder who do not respond to two or more currently available antidepressants News provided by Janssen Pharmaceutical Companies of Johnson Johnson https May ET Share this article javascriptvoid javascriptvoid javascriptvoid javascriptvoid javascriptvoid javascriptvoid TITUSVILLE N.J. May PRNewswire The Janssen Pharmaceutical Companies of Johnson Johnson today announced the results from two Phase clinical studies of the investigational compound esketamine nasal spray in patients with treatmentresistant depression. These studies will be presented at the American Psychiatric Association Annual Meeting taking place May in New York NY. Data from a study in adults with treatmentresistant depression showed that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant clinically meaningful rapid reduction of depressive symptoms as compared to placebo nasal spray plus a newly initiated oral antidepressant. The study defined treatmentresistant as patients who had not responded to two or more currently available antidepressants of adequate dose and duration in the current episode of depression. Data from a second study in elderly patients aged and older with treatmentresistant depression which is the first study of its kind showed treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant demonstrated clinically meaningful effects compared to placebo nasal spray plus a newly initiated oral antidepressant. However the study narrowly missed statistical significance for its primary efficacy endpoint. If approved by the U.S. Food and Drug Administration FDA esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last years. With about percent of patients with major depression failing to respond to currently available antidepressants treatmentresistant depression represents a major public health need said Husseini K. Manji MD Global Head Neuroscience Therapeutic Area Janssen Research Development LLC. The positive Phase results for esketamine nasal spray in adults with treatmentresistant depression are exciting particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder. What makes this even more significant is that the response was rapid and this milestone was achieved in patients deemed to be treatmentresistant. We are also pleased with the clinically meaningful outcomes for esketamine nasal spray in elderly patients a population that often has greater disability and lower response rates. Theres a critical need for new rapidly acting and effective treatment options for people with major depressive disorder who do not respond to existing therapies said Mathai Mammen M.D. Ph.D. Global Head Janssen Research Development LLC. Janssen is fully committed to exploring the newest science in the area of mood disorders and bringing these discoveries to patients in need. Click to Tweet httpsctt.ecPLxd Janssen announces new Phase data re. treatmentresistant depression httppo.stMUWqV Results of the Study in Adults with TreatmentResistant Depression In the Phase study of adults with treatmentresistant depression patients were randomized to flexibly dosed esketamine nasal spray mg or mg added to a newly initiated oral antidepressant or placebo nasal spray added to a newly initiated oral antidepressant. Primary Efficacy Endpoint The primary efficacy endpoint change from baseline in the Montgomerysberg Depression Rating Scale MADRS total score demonstrated the statistically significant clinical improvement in patients depressive symptoms for esketamine nasal spray plus an oral antidepressant at day Least Squares Mean Difference Standard Error from placebo nasal spray plus a newly initiated oral antidepressant . . Confidence Interval CI . . onesided p.. Secondary and Other Efficacy Endpoints The first key secondary endpoint onset of clinical response by hours postdose that is maintained through day numerically favored esketamine nasal spray plus an oral antidepressant vs. placebo nasal spray plus an oral antidepressant but did not meet statistical significance sided p.. The other two key secondary endpoints Sheehan Disability Scale SDS a subjectreported outcome measure widely used and accepted for assessment of functional impairment and associated disability and Patient Health Questionnaire PHQ a selfreport scale assessing depressive symptoms could not be formally evaluated since onset of clinical response was not statistically significant. Among other endpoints response rate was notable with . responding in the esketamine group vs. in the placebo group at days response improvement in MADRS from baseline. Remission rate MADRS total score at day was . and . for the esketamine and placebo groups respectively. The most common treatmentemergent adverse events reported in the esketamine group were metallic taste nausea vertigo dizziness headache drowsiness dissociation blurred vision paraesthesia tingling sensation and anxiety. The most common treatmentemergent adverse events reported in the placebo group were metallic taste and headache. Results of the Study in Elderly Patients with TreatmentResistant Depression Janssen conducted a separate Phase study in elderly patients with treatmentresistant depression. Elderly populations with major depressive disorder are historically hard to treat and often have comorbidities and longstanding depression. To improve tolerability patients were given a lower starting dose mg of esketamine nasal spray flexibly dosed at mg mg or mg plus a newly initiated oral antidepressant or placebo nasal spray plus a newly initiated oral antidepressant. Primary Efficacy Endpoint Although statistical significance for the primary endpoint for the overall patient population studied was narrowly missed results favored the esketamine nasal spray plus a newly initiated oral antidepressant group median unbiased estimate of the difference from placebo nasal spray plus a newly initiated oral antidepressant . CI . . onesided p.. To put this into context an analysis of placebocontrolled data from three prior studies conducted by Duru and Fantino determined that a minimum change in MADRS of . was clinically meaningful. In addition the average difference is between points for currently approved antidepressants vs. placebo. Safety results were consistent with previous studies of esketamine in younger adult populations. The most common treatmentemergent adverse events reported in the esketamine group were dizziness nausea headache fatigue increased blood pressure vertigo and dissociation. There were no treatmentemergent adverse events reported in of patients in the placebo group. Esketamine nasal spray has an acceptable safety and tolerability profile based on the adverse event data from both Phase studies. Adverse events and associated symptoms were seen predominately on the day of dosing and were generally transient and resolved on the day of dosing. These findings represent two of the five Phase studies that comprise Janssens treatmentresistant depression program with esketamine nasal spray. The results from these studies will inform regulatory filings for esketamine nasal spray in treatmentresistant depression for which Janssen has received Breakthrough Therapy Designations from the U.S. FDA. Data from other Phase studies will be presented later in . About the Studies In both Phase studies esketamine or placebo was provided in disposable nasal spray devices containing l of solution i.e. two sprays and administered under the supervision of a health care professional. A bittering agent was added to placebo to simulate the taste of esketamine to help mask the treatment assignment. The study in adults with treatmentresistant depression was a Phase doubleblind activecontrol flexibly dosed multicenter study using blinded raters conducted at sites in Czech Republic Germany Poland Spain and the United States from August to November . The study enrolled adults with moderatetosevere nonpsychotic recurrent or persistent depression and history of nonresponse to antidepressants in the current episode of depression with one of them assessed prospectively. Nonresponders were randomized to flexiblydosed esketamine nasal spray or mg twice weekly plus a newly initiated oral antidepressant N or placebo nasal spray plus a newly initiated oral antidepressant N. The primary efficacy endpoint change from baseline to day in MADRS total score was assessed among patients who received dose of nasal spray and oral study medication by mixedeffects model using repeated measures using a onesided significance level of .. .. For further information about this study visit the ClinicalTrials.gov httpsclinicaltrials.govctshowNCTtermNCTrank website. The study in elderly patients with treatmentresistant depression was a Phase doubleblind multicenter activecontrolled study. Patients years of age were randomized to either esketamine nasal spray plus a new oral antidepressant N or placebo nasal spray plus a new oral antidepressant N. The primary endpoint was the change in the MADRS total score from day baseline to day . Statistical analysis employed mixedeffects model repeated measures MMRM with a weighted combination test to account for an interim analysis for sample size reestimation using a onesided significance level of .. For further information about this study visit the ClinicalTrials.gov httpsclinicaltrials.govctshowNCTtermNCTrank website. About Esketamine Esketamine nasal spray is an investigational compound being studied by Janssen Research Development LLC as part of a global development program. Esketamine is a noncompetitive NmethylDaspartate NMDA receptor antagonist also known as a glutamate receptor modulator thought to help restore synaptic connections in brain cells in people with major depressive disorder. It has a novel mechanism of action meaning it works differently than currently available therapies for depression. Esketamine received Breakthrough Therapy Designations from the U.S. FDA in November for treatmentresistant depression and in August for the indication of major depressive disorder with imminent risk for suicide. About Major Depressive Disorder Major depressive disorder affects nearly million people of all ages globally and is the leading cause of disability worldwide. Individuals with depression including major depressive disorder experience continuous suffering from a serious biologically based disease which has a significant negative impact on all aspects of life including quality of life and function. Although currently available antidepressants are effective for many patients about one third of patients do not respond to treatment and are thought to have treatmentresistant depression. About the Janssen Pharmaceutical Companies of Johnson Johnson 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 at http and http 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 potential benefits of esketamine. 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 Janssen Research Development LLC 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 competition including technological advances new products and patents attained by competitors challenges to patents manufacturing difficulties and delays changes in behavior and spending patterns or financial distress 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 description of these risks uncertainties and other factors can be found in Johnson Johnsons Annual Report on Form K for the fiscal year ended January including in Exhibit thereto 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. None of the Janssen Pharmaceutical Companies or Johnson Johnson undertakes to update any forwardlooking statement as a result of new information or future events or developments. . National Institute of Mental Health. Sequenced Treatment Alternatives to Relieve Depression STARD Study. Available at http_edn http Accessed May . . The clinical relevance of changes in the MontgomeryAsberg Depression Rating Scale using the minimum clinically important difference approach. Available at https Accessed May . . Khin NA https_uid et.al. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications Journal of Clinical Psychiatry. April . Available at https Accessed May . . Johnson Johnson Press Release. Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Available at https Accessed May . . World Health Organization. Depression. Available at http Accessed May . . Thase ME. Update on partial response in depression. J Clin Psychiatry. suppl ."

"A Veterans Affairs database study of more than patients found that men whose low testosterone was restored to normal through gels patches or injections had a lower risk of heart attack stroke or death from any cause versus similar men who were not treated. The study also found that men who were treated but did not attain normal levels did not see the same benefits as those whose levels did reach normal. The study was published online Aug. in the European Heart Journal. The findings may sway the ongoing debate over testosterone therapys benefits and risks especially for the heart. Studies over the past few years have yielded mixed results although part of that might stem from differing patient populations and research methods. For example the new VA study excluded men with a history of heart attacks or strokes although it did include those with existing heart disease. A muchcited VA database study that was published in JAMA in looked specifically at men with coronary artery disease about percent of the total study group of around men had suffered a prior heart attack. So far the medical community lacks results from any definitive clinical trial that might provide clear guidance. Meanwhile the Food and Drug Administration issued guidance earlier in advising clinicians about the overuse of testosterone therapy and pointing to a possible increased risk of heart attack and stroke. The new VA study is likely to draw attention because of its large size and relatively long followup period. Dr. Rajat Barua the papers corresponding author says the study is also noteworthy because of its finding that administering the right dose is critical Treating low T but not restoring levels to normal doesnt appear to impart much benefit at least in terms of cardiovascular risk. Testosterone isnt prescribed with the goal of improving heart health but that is a consideration in many cases. It is the first study to demonstrate that significant benefit is observed only if the dose is adequate to normalize the total testosterone levels Barua and his coauthors wrote. Patients who failed to achieve the therapeutic range after testosterone replacement therapy did not see a reduction in heart attack or stroke and had significantly less benefit on mortality. Barua is with the Kansas City Mo. VA Medical Center. Hes also an assistant professor of medicine at the University of Kansas. The study team looked at national data on more than men with documented low testosterone all age or above who received care in VA between and . The researchers divided the men into three clinical groups those who were treated to the point where their total testosterone levels returned to normal Group those who were treated but without reaching normal Group and those who were untreated and remained at low levels Group . Importantly all three groups were propensity matched so the comparisons would be between men with similar health profiles. The researchers took into account a wide array of factors that might affect cardiovascular and overall risk. They included for example age body mass index various chronic diseases LDL cholesterol levels and the use of aspirin beta blockers and statins. The average followup across the groups ranged from . to . years. The sharpest contrast emerged between Group those who were treated and attained normal levels and Group those whose low testosterone went untreated. The treated men were percent less likely to die during the followup period percent less likely to suffer a heart attack and percent less likely to have a stroke. The differences between Group and Group those who were treated but did not attain normal levels were similar but less pronounced. Little difference emerged between Groups and except for a slight benefit in survival for those who were treated. Barua and colleagues say they dont know the exact reasons for testosterones apparent benefits for the heart and overall survival. The mechanisms for these effects remain speculative they write. Possible explanations they say could involve body fat insulin sensitivity lipids blood platelets inflammation or other biological pathways. More research is needed they say to clarify how testosterone affects the cardiovascular system. While the new study results do seem to advocate for testosterone replacement therapy Barua stresses the need for appropriate screening selection dosing and followup of patients to maximize the benefit of testosterone therapy. The authors also caution that offlabel use remains a concern. In other words doctors should not write a prescription simply because an older man is complaining of symptoms such as low energy and low sex drive. According to the FDA Testosterone products are FDAapproved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. ... None of the FDAapproved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition."

"Men who eat lots of tomatoes and tomatobased products may have a lower risk for stroke https a new study suggests. Tomatoes are rich in the antioxidant https lycopene. Men who had the highest levels of lycopene in their blood https were less likely to have a stroke https compared with men who had the lowest levels of the antioxidant in their blood https The lowered risk was even greater for strokes caused by blood clots https in the brain https called ischemic strokes. These are the most common type of stroke https Men who had the highest lycopene levels were less likely to have this kind of stroke than men with the lowest levels. The findings appear in the Oct. issue of Neurology. The new study included slightly more than men from Finland aged to . Researchers measured the level of lycopene in their blood when the study began and followed the men for about years. During that time men had a stroke. This study adds to the evidence that a diet high in fruits and vegetables https is associated with a lower risk of stroke says researcher Jouni Karppi PhD of the University of Eastern Finland in Kuopio. The results support the recommendation that people get more than five servings of fruits and vegetables https a day which would likely lead to a major reduction in the number of strokes worldwide according to previous research. Other studies have shown that high lycopene levels may be linked to a reduced risk of certain cancers. Cooked tomatoes tend to have a greater effect on blood levels of lycopene than raw tomatoes or tomato juice. Tomatoes are not the only food that is rich in this antioxidant. Other sources include pink grapefruit watermelon and guava. Healthy Diet Lowers Stroke Risk Lycopene seems to have some beneficial effects when in the form of fruits and vegetables https says Deepak Bhatt MD. He is the director of the Integrated Interventional Cardiovascular Program at Brigham and Womens Hospital in Boston. The benefits likely only apply to whole foods not individual supplements https_AssetsscopemapsWebMDConsumerPagesVitaminsandSupplementsLifestyleGuide_ecedpage_VitaminsandSupplementsLifestyleGuide_eced.xml of lycopene. Eat more fruits and vegetables to reduce your risk of stroke is a safe conclusion he says. The new study only included men but the same benefits likely extend to women. Although eating more vegetables is good advice the study looked at lycopene levels in blood not at how many tomatoes the men ate says Daniel Labovitz MD. He is the director of the Stern Stroke Center at Montefiore Medical Center in New York City. Whats more the study just showed a link. It was not designed to say whether or not eating more tomatoes can lower stroke risk. There is no reason to think that tomatoes are bad but we havent proven that they are special either he says. One of the best ways to lower stroke risk is to eat a healthy diet that is rich in fruits and vegetables and to exercise https regularly. Lifestyle changes are better than any pill we can prescribe. Rafael Ortiz MD is less cautious in his interpretation of the study. I would definitely recommend an increased intake of fruits and vegetables especially tomatoes to decrease your chances of stroke he says. He is the director of the Center for Stroke and NeuroEndovascular Surgery at Lenox Hill Hospital in New York City. The study also shows that smokers tended to have the lowest blood levels of lycopene. Smoking https is a major risk factor for stroke."

"Overweight people could be given help with the discovery that a drug used for sleep disorder could also reduce the impulse for food. There are many factors that cause obesity but there is a growing weight of evidence that shows obesity is not just caused by a behavioural disorder such as a lack of selfcontrol but that many overweight people are physically addicted to foods rich in fat and sugar. When we eat food that tastes good we get a powerful release of dopamine in the pleasurereward section of the brain but food addicts have been found to have a deficiency in a certain type of dopamine so that their sense of reward and pleasure is diminished thus they have to eat more to reach the same level of pleasure as anybody else. Scientists have also found impulsive behaviour is a factor in leading to food addiction and Ivo Vlaev of Warwick Business School plus Myutan Kulendran Laura Wingfield Colin Sugden and Ara Darzi of Imperial College London discovered that a drug called Modafinil usually used for narcolepsy shift work disorder and excessive daytime sleepiness can reduce impulsivity and thus food addiction. We found Modafinil which is already on the market did reduce peoples impulsive behaviour said Professor Vlaev. It has been shown to reduce impulsiveness in a variety of disorders such as alcohol dependence schizophrenia and ADHD. Food addicts suffer from the same neurobiological conditions so we believe it will help food addicts as well and our initial tests have backed up that theory. This could have important implications for people who are obese. There is mounting evidence to show that there is a substantial number of obese people who are food addicts because they have an inability to control their impulsive actions and this drug has shown it can give them more control which will help overweight people lose weight and so improve their health. Food addicts know they need to lose weight but the desire for more food is overwhelming leading to a spiral of depression that can lead to psychological issues as well as health problems. The drug which is sold under a wide variety of brand names around the world was one of two drugs tested by researchers the other being Atomoxetine. Both drugs have been used for impulsive conditions including ADHD. In the paper Pharmacological manipulation of impulsivity A randomized controlled trial published in Personality and Individual Differences the scientists conducted a series of trials on men aged between and with taking a placebo Atomoxetine and Modafinil. The tests revealed that those who had taken Modafinil had a significantly reduced level of impulsiveness whereas Atomoxetine produced no difference compared to the placebo group. Modafinil was found to have an effect on impulsivity in healthy individuals and so would be able to have an even bigger effect on food addicts who are lacking in certain types of dopamine said Professor Vlaev. This drug could be a real help to those people struggling to control their desire for food even though they know they should lose weight. The drug improves selfcontrol which is a key factor in determining obesity so our hypothesis is that this drug should help in treating the disease. For a copy of the paper email Ashley.potterwbs.ac.uk mailtoAshley.potterwbs.ac.uk To interview Ivo Vlaev contact Email Ivo.Vlaevwbs.ac.uk mailtoIvo.Vlaevwbs.ac.uk Warwick Business School is the largest department of the University of Warwick and is triple accredited by the leading global business education associations the first in the UK to attain this accreditation. Offering the full portfolio of business education courses from undergraduate through to MBAs and with a strong Doctoral Programme WBS is the complete business school."