Health, Latest News	Cannabis, CULLING, DEA, death, FDA, Hemp, Marijuana, opioids, Pain Management, patient abuse, Patients, patients rights, suicide
As the feds crack down on opioid prescriptions, patients are taking their own lives, doctors are losing their jobs and overdose rates continue unabated.
July 31, 2018 Sheree Krider
The Government's Solution To The Opioid Crisis Feels Like A War To Pain Patients
By Art Levine
Jay Lawrence, an energetic truck driver in his late 30s, was driving a semitrailer across a bridge when the brakes failed. To avoid plowing into the car in front of him, he swerved sideways and slammed the truck into a wall, fracturing his back. For more than 25 years, he struggled with the resulting pain. But for most of that time, he managed to avoid opioid painkillers.
In 2006, his legs suddenly collapsed beneath him, due to a complex web of neurological factors related to his spinal cord injury. He underwent multiple surgeries and tried many medications to alleviate his pain.
The next year, he began to experience some semblance of relief when his doctor prescribed morphine, one of a class of opioid drugs. By 2012, he was taking 120 milligrams per day.
But this isn't a story about opioid addiction. Lawrence managed a relatively productive, happy life on the medication for the better part of 10 years.
"This isn't the life I thought I'd have," he told his wife, Meredith Lawrence, in December 2016. "But I'm all right."
Living on disability payments, he could still walk around their two-bedroom trailer home using his cane, take a shower on his own and, on his good days, even help his wife make breakfast.
Then, in early 2017, the pain clinic where he was a patient adopted a strict new policy, part of a wide-ranging national effort to respond to the increase in opioid overdose deaths.
Citing 2016 guidelines from the U.S. Centers for Disease Control and Prevention, her husband's doctor abruptly cut his daily dose by roughly 25 percent to 90 mg, Meredith Lawrence said. That was the maximum dose the CDC recommends, though does not mandate, for first-time opioid patients.
The doctor also told Jay Lawrence that the plan was to lower his dose to 45 mg over the next two months, a cutback of more than 60 percent from what he had been taking.
At the end of that traumatic visit, his wife said, Jay Lawrence's doctor dismissed their concerns and shared his own fear about losing his license if he continued to prescribe high doses of opioids. (When HuffPost followed up, the doctor declined to comment on the case, citing patient privacy.)
For a month, Lawrence suffered on the 90 mg dose. At times, his pain was so bad that he needed help to get out of the recliner, and when his wife looked over, she sometimes saw tears streaming down his face.
He dreaded his next appointment when his dose would be slashed to 60 mg. In the weeks before that scheduled visit on March 2, 2017, Lawrence came up with a plan.
On the day of his appointment, on the same bench in the Hendersonville, Tennessee, park where the Lawrences had recently renewed their wedding vows, the 58-year-old man gripped his wife's hand and killed himself with a gun.
Dustin Chambers for HuffPost Meredith Lawrence sits in the living room of the home in Gainesville, Georgia, that she bought after her husband's death.
There are at least nine million chronic pain patients in the United States who take opioid painkillers on a long-term basis. As law enforcement and medical regulatory bodies try to curb the explosion in opioid deaths and the rise in illegal opioid use, they have focused on reducing the overall opioid supply, whether or not the drugs are provided by prescription.
There's mounting evidence this won't work ― that curbing patient access to legal prescription opioids does not stem the rate of overdoses caused primarily by illegal drugs ― and that patients are being denied desperately needed relief. There are also troubling indicators that cutting back on opioids increases the risk of suicide among those with chronic pain.
Some chronic pain patients and advocates have even begun compiling lists of individuals they know who have died by suicide after they were no longer able to treat their pain with opioid medication.
"There is no doubt in my mind that forcibly stopping opioids can destabilize some of the most vulnerable people in America," said Dr. Stefan Kertesz, a professor of medicine and an addiction researcher at the University of Alabama at Birmingham. "And the outcomes for those folks include suicide, overdose and falling apart medically."
I mean, people need to take some aspirin sometimes and tough it out a little. Attorney General Jeff Sessions
For a decade or so, government officials in the U.S. have sought to drive down the opioid supply through a range of tactics ― from increased seizures of diverted opioid medications to state crackdowns on "pill mills." The Trump administration has embraced the hard-line approach.
In late January, Attorney General Jeff Sessions announced a "surge" in Drug Enforcement Administration activity targeting pharmacies and physicians that, in the agency's view, oversupply opioids. In February, the Justice Department doubled down with the announcement of a new task force that would focus on manufacturers and distributors of opioids. In March, President Donald Trump unveiled a plan to lower opioid prescriptions by a third within three years. And in late June, the federal government arrested 600 people, including 165 medical professionals, for allegedly participating in $2 billion worth of fraud schemes involving opioids.
The Trump administration's efforts are dramatic even within the context of the CDC's opioid dose guidelines. The guidelines were originally intended to advise primary care physicians treating chronic pain patients and other pain sufferers. They were urged to exercise caution in prescribing opioids, to use alternatives whenever possible and to prescribe daily doses of no more than 90 morphine milligram equivalents (MME) for new opioid users.
For pain patients like Jay Lawrence who had already been on opioids for years, h
owever, the guidelines simply recommended regularly assessing the harms and benefits of the dosage. They didn't advise either mandatory cutoffs or any set limits. (The Tennessee Department of Health's guidelines would also have allowed Lawrence to stay at 120 mg of morphine when prescribed by a pain specialist.)
But "the CDC guidelines have been weaponized," said Kertesz. The ramped-up enforcement by the DEA and state regulators has led some doctors to choose caution and to overcorrect in their prescribing, lest they lose their ability to practice medicine at all. Kertesz decried these policies as "simplistic" in a definitive new article published last week in the journal Addiction.
In February, Sessions struck a particularly harsh tone by suggesting that the fate of chronic pain patients was not high on his list of concerns. "I am operating on the assumption that this country prescribes too many opioids," the attorney general said. "I mean, people need to take some aspirin sometimes and tough it out a little."
Attitudes like that are based on a series of mistaken assumptions about pain, according to Dr. Thomas Kline, a North Carolina-based family practitioner and former Harvard Medical School program administrator. Kline regularly updates a list of pain patients, published on Medium, who've killed themselves in the wake of draconian restrictions on pain medication.
"I ask people to imagine the very worst pain they've ever experienced in their lives," Kline said. "And then that they're denied relief by a doctor with the one medicine proven effective for pain control for 50 centuries." (Historical records show that people in ancient Mesopotamia cultivated the poppy plant for medical use.)
The CDC guidelines have been weaponized. Dr. Stefan Kertesz
The government's aggressive focus on doctors and patients is unlikely to address the very real menace of opioid-use disorders and sharply escalating overdose deaths. Fraud ― driven by pharmaceutical company policies ― and diversion ― the phenomenon of prescription medications being sold as street drugs ― initially spurred a wave of opioid abuse in the late 1990s, as some doctors turned their practices into pill mills. But new reports by the CDC and a drug data firm, the IQVIA Institute for Human Data Science, suggest that prescription drugs play a much smaller role in today's crisis.
The reports show that total opioid prescriptions dropped 10 percent in 2017 ― the sharpest annual decline in such prescribing in 25 years. While opioid prescriptions peaked back in 2010, the studies found that growth rates in opioid-linked deaths, overwhelmingly due to illegal fentanyl and heroin, have skyrocketed in the last seven years.
Indeed, although two-thirds of the 64,000 overall drug overdose fatalities were linked to opioids in 2016 ― the most recent year for which there is data ― more than 80 percent of those opioid drug deaths came from illegal street drugs such as heroin and fentanyl. Prescription opioid drug deaths alone ― excluding methadone ― amounted to less than 15 percent of all drug overdose deaths, or about 9,500 fatalities.
Still, the CDC's guidelines have triggered restrictive laws in at least 23 states that mandate ceilings on opioid dosage. (Oregon, in fact, is moving to taper dosages down to zero for all Medicaid chronic patients over a year.) That makes relief less attainable for pain patients and threatens the practices of doctors who treat them. These laws have been augmented by the growth of state prescription monitoring programs that use the software NarxCare, which is designed to flag addiction but can also rope in pain patients based on their prescription history and use of multiple doctors.
And in June, the House of Representatives passed over 50 bills that would establish dramatic new restrictions on opioid prescribing, eliciting alarm among patients and some disability rights groups.
The side effects of the current enforcement efforts are disturbing enough, from patients denied relief to drug shortages to suicides.
No health agency has kept track of all pain-related suicides that may be linked to doctors cutting back on prescriptions. But some preliminary findings from Department of Veterans Affairs researchers indicate that VA pain patients deprived of opioids were two to four times more likely to die by suicide in the first three months after they were cut off, compared to those who remained on their pain medications.
"To protect people, you have to take care of the patient, not the pill count," said Kertesz, who worked on the VA's April 2017 study but spoke to HuffPost only as an independent researcher. "The findings suggest that the discontinuation of opioids doesn't necessarily assure a safer patient."
Even terminally ill cancer patients are increasingly getting less relief, and there are growing shortages of injectable opioids at local hospitals and hospices, spurred in part by DEA-ordered reductions in opioid manufacturing quotas.
Leah Ilten, a 53-year-old physical therapist who lives in Kennewick, Washington, told HuffPost that as her 86-year-old father lay dying of pancreatic cancer in a hospice, the medical staff ignored her pleas to provide appropriate opioid pain relief, even cutting his dosage in half on the last day of his life. A few days earlier, when he was in the hospital, one nurse explained to her that opioids could lead to an overdose or could potentially cause the man, who lay moaning in pain, to "get ad
dicted."
"I was horrified," Ilten said.
In mid-April, the DEA responded to the injectable opioid shortage by lifting production quotas. An agency spokesman told HuffPost that it was "a manufacturers' problem, not the quotas," while asserting that progress is being made.
There have been production issues, including Pfizer's foul-ups with a plant in Kansas. But the DEA's delay in taking action ― shortfalls were flagged in February in a letter from the American Society of Anesthesiologists and other health groups ― definitely contributed to the shortage, according to Dr. James Grant, president of the ASA. He told HuffPost that quotas were among the factors creating the crisis.
I'm not willing to go back to the state I was in before I started treatment. Anne Fuqua
Faced with the hardline national crackdown on opioid prescriptions, people with chronic pain are trying to raise awareness of the suffering caused by the loss of medications. Some are gathering the names of those patients who ended up taking their own lives, both as a memorial to those who died and as a protest against the health establishment that has seemingly abandoned them. Others are seeking comfort from each other on social media.
Lelena Peacock, who declined to name her southeastern city of residence for fear of retaliation from doctors, is struggling with how to treat the pain associated with fibromyalgia. The 45-year-old found that her social media posts drew other pain patients who turned to her for help.
By her own count, Peacock has thus far convinced more than 70 chronic pain patients to call 911 or suicide prevention hotlines instead of killing themselves.
For Anne Fuqua, a 37-year-old former nurse from Birmingham, Alabama, the motivation for compiling a list of chronic pain-related suicides is to track the damage done by what she sees as policies that have left people like her behind.
"There's so many people who have died," she said. "We have to remember them."
Fuqua has an incurable neurological illness known as primary generalized dystonia that causes Parkinson's-like involuntary movements and painful muscle spasms. She started taking about 60 mg of Oxycontin a day in 2000. Her doctor began to limit her access to high doses of opioids in 2014, the same year she started chronicling those friends who had killed themselves or otherwise died after being denied pain medications. Her informal list is now up to roughly 150 people, augmented by lists that other pain patient advocates have compiled.
On July 9, Fuqua joined other chronic pain patients at a meeting at the Food and Drug Administration campus in Maryland to express their fears and outrage at the cutbacks. Sitting in the front row in her wheelchair, she told FDA officials about that list and declared, "I'm not willing to go back to the state I was in before I started treatment."
Courtesy of Anne Fuqua Anne Fuqua needs exceptionally high doses to manage her pain because of opioid malabsorption.
Fuqua's own difficulties are compounded by the fact that her body does not respond to even large doses of opioids the way others do ― she suffers from severe malabsorption that hampers her ability to benefit from everything from opioids to vitamin D. Since 2012, she has relied on a strikingly high daily regimen of 1,000 MME of opioids, including fentanyl patches, to manage her pain.
But her physician, Dr. Forrest Tennant, was driven to retire this year after a DEA raid and investigation. The Los Angeles-area physician mailed her a final series of prescriptions, which will run out at the end of July.
"It's terrifying," she said looking at her future. "If these were people who had asthma or diabetes and weren't stigmatized because of opioids, this wouldn't be allowed to happen."
Another doctor has quietly stepped forward to continue treatment for Tennant's remaining patients, Fuqua said, although there's no assurance that this physician won't also be investigated in the future.
If these were people who had asthma or diabetes and weren't stigmatized because of opioids, this wouldn't be allowed to happen. Anne Fuqua
The raid on Tennant's home and office last November illustrates the hard-line regulatory and enforcement approach that critics say doesn't distinguish between pill-mill doctors who deserve to be shut down and legitimate pain doctors who use high-dosage opioids. The wide-ranging search warrant served to Tennant essentially accused him of drug trafficking even though he'd earned a national reputation for deft treatment of ― and research about ― pain patients.
"He's highly respected and prominent in pain management," said Jeffrey Fudin, a clinical pharmacy specialist who heads the pain pharmacy program at the Albany Stratton VA Medical Center in Albany, New York, and serves as an associate professor at the Albany College of Pharmacy and Health Sciences. "Most of his patients had no other options, and they came from around the country to see him."
Tennant was known for taking on difficult-to-treat patients, including those suffering from pain as a result of botched surgeries and other forms of malpractice. His research included innovations in the use of hormones to alleviate pain and lower opioid use up to 40 percent, as well as work on genetic testing for enzyme system defects that lead to opioid malabsorption.
"The DEA can trigger an investigation every time they misapply the CDC guidelines without paying attention to the population the physician treats or issues of medical necessity," said Terri Lewis, a patient advocate and a Ph.D. clinical rehabilitation specialist with Southern Illinois Uni
versity who trains clinicians on how to manage seriously ill patients with incurable pain.
Special Agent Timothy Massino, a spokesperson for the DEA's Los Angeles division, declined to comment on the agency's approach to Tennant. "It's an ongoing investigation," he noted.
Tennant's isn't alone. Physicians must now balance their prescribing obligations to their patients with legitimate fear for their livelihoods.
DEA enforcement actions against doctors have risen some 500 percent in recent years ― from 88 in 2011 to 449 last year, according to an analysis of the comprehensive National Practitioners Data Bank by Tony Yang, a professor of health policy at George Washington University. Even though that's a relatively small number of arrests compared to the roughly one million physicians in the country, such arrests can have an outsized impact.
"They make big news, and they serve as a deterrent for physicians whose specialties require them to use a lot of pain medications," Yang said. "It makes them think twice before prescribing opioids."
Dustin Chambers for HuffPost Meredith Lawrence shows the tattoo she got after her husband'€™s death. The bluejay represents her husband, Jay; a cup of coffee is the way she loves to start her day; and the quote is "Sail away with me, what will be will be."
Dr. Mark Ibsen of Helena, Montana, found himself in a five-year battle against the state licensing board that's still not over ― even though a judge last month reversed the board's decision to suspend his license because of due process violations. The court has remanded the case back to the licensing board for potential further investigation of his opioid prescriptions, but Ibsen has decided he won't resume his medical practice.
That's bad news for Montana, which has the highest rate of suicide in the country, according to the CDC. What's more, chronic pain-related illnesses account for 35 percent of all the state's suicides, as a recent state health department study found.
In the course of his fight with the medical board, the 63-year-old doctor said three of his former chronic pain patients have killed themselves after he and other doctors stopped prescribing opioids. The first of those patients died shortly after attending a hearing to show his support for Ibsen.
The deaths of pain patients haunt those who treated them and loved them. Meredith Lawrence, who sat with her husband to the very end, said, "It was as horrifying as anything you can imagine."
"But I had the choice to help him or find him dead someday when I came home," she added.
Lawrence was arrested and sentenced to a year's probation for assisting a suicide. Now her goal is to fight restrictions on opioid prescriptions.
"If we don't stand up, more people will die like my husband."
If you or someone you know needs help, call 1-800-273-8255 for the National Suicide Prevention Lifeline. You can also text HOME to 741-741 for free, 24-hour support from the Crisis Text Line. Outside of the U.S., please visit the International Association for Suicide Prevention for a database of resources.
Art Levine is the author of Mental Health, Inc: How Corruption, Lax Oversight, and Failed Reforms Endanger Our Most Vulnerable Citizens.
That study isn't without flaws. Veterans die by suicide at higher rates than average ― currently accounting for 20 suicide deaths a day ― so they are not a nationally representative sample. And the VA study, which was released at a national opioid summit in early April, has not yet been submitted for peer review.
But another study, published last year in the peer-reviewed journal General Hospital Psychiatry, looked at nearly 600 veterans who in 2012 were cut off from dosages after long-term opioid use and found similar results. Twelve percent of the vets showed suicidal ideation or took violent action to harm themselves ― a rate nearly 300 percent higher than the overall veterans community.
Latest News, Mental Health, PHARMA	Cannabis, CULLING, DEA, death, FDA, Hemp, Marijuana, opioids, Pain Management, patient abuse, Patients, patients rights, suicide
"The DEA can trigger an investigation every time they misapply the CDC guidelines without paying attention to the population the physician treats or issues of medical necessity," said Terri Lewis, a patient advocate and a Ph.D. clinical rehabilitation specialist with Southern
Illinois University who trains clinicians on how to manage seriously ill patients with incurable pain.
CBD/Cannabidiol, Latest News	Cannabis, CBD, Corporate Cannabis, DEA, FDA, Hemp, Hops, Humulus, Humulus Oil, Kriya, Marijuana, RHSO
World's First Non-Cannabis CBD Oil Is High on Hops
Nick Maahs | July 28, 2018 | 5:56am
Cannabidiol enthusiasm is reaching a fever pitch in Colorado. Consumers snarf CBD down in doughnuts, slurp it up with CBD-infused lattes, lather it on with lotions, gulp it down in capsules and, of course, puff it the old-fashioned way with high-CBD pot strains. But while the CBD craze consumes Colorado, CBD remains illegal in many American markets, since it is still labeled by the DEA's Schedule I as having "no currently accepted medical use and a high potential for abuse."
But there is a loophole: for CBD that is not derived from cannabis. And the Peak Health Foundation took advantage of that loophole to create Real Scientific Humulus Oil (RHSO-K), a CBD oil derived from the kriya brand humulus plant. Because that plant is a variety of hop, not cannabis, the oil is legal in this country.
The FDA Just Approved a CBD Drug. What Does That Mean for Colorado?
Discovered by Bomi Joseph in the Silk Road region of northern India, kriya brand humulus is naturally endowed with a high concentration of CBD because the hop plants cross-pollinate with wild cannabis plants that grow nearby. Peak Health, a San Francisco holistic medicine center where Joseph is the director, extracts a CBD oil from these plants that's dubbed ImmunAG.
Though his discovery and cross-breeding of kriya brand humulus may be a fresh development, the plant's story dates back to the mid-1800s when John Sullivan was a British governor in the southern part of India. Sullivan was ahead of his time, Joseph says: "He believed in natural health; he believed in natural curing. And he was powerful, right, he had the British government, they ruled India. He could do what he wanted. He made an estate called Stone House in a place called Ooty — it's a cool-climate, hilled station in the southern part of India — and he had the British soldiers bring plants from all over the country and plant them there."
Sullivan's Stone House became a sanatorium for the British. When they felt sick or in need of some rest and relaxation, they would go there, taking solace in the hills. Years later, researchers identified a variety of humulus yunnanensis at Stone House that was useful in treating malaria.
"That got my attention," Joseph says, "because normally when people talk about yunnanensis, they talk about China, the Yunnan province. So the fact that in the southern part of India, where my family is historically from, you find this humulus yunnanensis, I was like, 'How the hell did it get there?'"
He was determined to find out. Then Ari Cohen, one of his colleagues at Peak Health, found a reference to the yunannensis plant at a symposium given by India's Central Food Technological Research Institute. Their analysis of the plant discovered traces of cannabinoids.
Joseph cites this as his first tip. "I knew that there was a chance of this [cannabis-humulus cross-pollination] actually happening," Joseph recalls, so he headed to northern India and started searching. "In the beginning it was hard, because the native tribes people there, they're all sitting and looking at me like, 'What is this crazy guy doing?' They're like the porters, we had hired them and they're wandering around chewing betel nut, drinking their rice wine and sitting around looking at me. For a few weeks it was crazy, but then I finally showed them what we're looking for. Once they got it, they were just taking me here, taking me there, showing me this, showing me that. I was like, 'No, no, no,' but then we found it. It started getting faster and faster. Once they found some and we found some, then we started getting samples. But we looked at thousands of samples before we found one or two that had CBD in it."
A mature pod on a kriya humulus plant Kathryn Reinhardt, CMW Media
After that, though, "We were in good shape," Joseph says. "Then it was just a matter of grunt work and effort," cross-breeding the plants (in which CBD is a recessive trait) until they'd created a dependable, high-CBD concentration variety.
Joseph's kriya brand humulus is a variety of humulus yunnanensis, one of three species of the humulus genus. Distinct from humulus lupulus — a different species of hop, the one from which the female flowers (known as hops, plural) are used to make beer — humulus yunnanensis is native to the Yunnan province in southern China, along the Indian border. Here, the plant was able to cross-pollinate with wild cannabis, as both genera are members of the same family of flowering plants, cannabaceae. This endowed kriya brand humulus with trace amounts of CBD and, in some cases, THC. Avoiding the latter, Joseph and his team meticulously selected and cross-bred plants with high concentrations of CBD until they arrived at a variety — kriya brand humulus — with an 18 percent CBD concentration. Joseph holds a patent for this as well as the modification of any other humulus plant to produce CBD and cannabinoids.
Through a partnership with distributor Medical Marijuana Inc. (which previously made headlines as the first publicly traded cannabis company in the U.S.), what's now known as ImmunAG is combined with medium-chain triglyceride oil to form RSHO-K. Last month, Medical Marijuana Inc. made the product available to consumers nationwide via its online store.
Since it's free of THC and the cumbersome legal baggage of cannabis, RSHO-K gives Stuart Titus, CEO of Medical Marijuana Inc., high hopes. Beyond simply filling gaps in the U.S. CBD market, he expects the product to have an international impact. "This is certainly going to help change the dialogue for not only many parents whose children have epilepsy," he says, "but various other world markets which still, of course, consider cannabis part of the United Nations single convention treaty on narcotics."
Looking back, Joseph is grateful for his luck. "If John Sullivan hadn't planted it and if a mention had not been made of it, I don't know if we would have had a clue," he says. "He did something that made it stick out and that led us to it. I'm sitting here in my office in Los Gatos, a fancy little place. I've got 500 megabit WiFi speeds; I can Google anything. But the reality is, we haven't studied more than 4 percent of all the plants that are out there. If I want to go beyond the 4 percent, I've got to go to the Amazon jungles, the Himalayan mountains; there's no other way. We've got to go get bitten by mosquitoes, chewed up by leeches and deal with the heat and humidity, there's no other way."
Latest, ShereeKrider	Cannabis, CBD, DEA, FDA, Hemp, legalization, Marijuana, merchant services, Pure Spectrum CBD, Repeal, Repeal Prohibition, USPS
What Is Legal and What Is Not??? "I was arrested for multiple felonies…in KNOX County Tennessee for possessing Industrial Hemp"
Please view video above.
Following the passing of the 2014 Farm bill, the Kentucky Department of Agriculture launched the Industrial Hemp Research Program that would allow farmers and processors to begin the development of an industry. LINK
There has been some disconcerting news showing up on social media in the past few days. It seems the DEA may be trying to push buttons…
They picked the right words for it, "Hemp Research" Bill, because that is exactly what they have been doing since the research started…using our Farmer's to start an industry that they damn well knew they would not let them keep for very long. The idea is to let the Farmer's do the work for the start-up so that they think that they are accomplishing a great feat, (which they are), and then yank it right out from under them via the DEA and hand it over to the Pharmaceutical Conglomerates where they can make big money by controlling our access to the Cannabis plant.
The fact is that it was not "Marijuana" that they were worried about infiltrating the Nation, it was controlling the Hemp – and now the CBD. Marijuana is just the control button so to speak.
It all comes back around to the NWO and Agenda 21 to control the masses. (If you control the food – and medicine, you control the people). But first they want to make sure that everyone wants and/or needs what they are going to take control of. Once the market starts to bloom, it's time to take it back.
I first noticed a problem about two months ago when Stripe discontinued merchant services for the U.S. Marijuana Party, stating it was a prohibited business. I sell nothing but T-Shirts, lol. I went to my bank and asked them about it and sure enough, they weren't accepting any "marijuana related" business either. So, I have no way to sell T-Shirts online at this time. Unless I want an offshore bank account!
On July 18th, Brady Bell broke the news that USPS was, as of the 17th "…ceasing all shipping of hemp/CBD products. The inspector said they are going to start confiscating any products that violate their stance…"
Jaime Rothensteinenheimer is feeling heartbroken
I was arrested for multiple felonies at 1pm Wednesday July 18, 2018 in KNOX County Tennessee for possessing Industrial Hemp. My charges are Possession of Sched 6 drugs with Intent to Deliver (marijuana). The COA and 3rd Party Lab Reports were with the hemp products. I was forced to sleep on the porch of a Fireplace Store in Sevierville, TN until the impound opened to retrieve my vehicle. I am being arraigned tomorrow morning at 10am in Knox County Courthouse for Multiple felony charges.
On Wednesday July 18, 2018 at 11am the DEA raided my suppliers warehouses in SC and FL, took controlled samples for testing and went about their business. No charges yet . On Friday July 20,2018 the Atlantic Beach Police Dept had me sign a form to allow the Search of my business, Terp Market and Lounge, due to the City Commission claiming that "nefarious" characters were coming and going. I complied and the detectives were very polite. It still grinds my gears that we are doing positive things in the community and are getting treated like criminals over a PLANT. LINK
From Brady Bell, of Pure Spectrum CBD, Colorado…
As an industry we have to take a stand. I now know why this is happening. GW Pharmaceuticals are the reason behind this with their lobbying efforts. It's time the industry takes a stand and we file a class action lawsuit on GW Pharmaceuticals. I have the plan in motion. I will be reaching out to owners and anyone else that wants to join the battle. Feel free to email me, Brady@purespectrumcbd.com. We have the legal team and direction. The rest will require unity. LINK
EVERYONE in the CANNABIS business, whether legal or not, whether it is Hemp or Marijuana/Cannabis that you sell, or USE for medicine or recreationally, should pay very close attention to what is happening right now. The quality of Our lives very much depends upon what happens with Cannabis.
Hemp almost legal as Big Pharma moves in on CBD
Please read the above linked article.
On my end, I am concerned about the control of Cannabis/Hemp and the regulations which will follow legalization and what it means to the prison industrial complex. I am concerned about the right to grow a Cannabis plant in my yard and use it personally for medicine and pleasure. I am concerned about all the children and other people who were so wrongly denied the Cannabis plant since 1937 and before, who so badly needed it as a medication, which was ALREADY IN THE PHARMACOPEIA IN 1900'S, but that the Government pulled out from under them in the name of commerce.
DEA guidance is clear: Cannabidiol is illegal and always has been
Cannabis, Hemp, Marijuana are all born from the same species. Don't let them divide us!
NEVER say legalize! ALWAYS push for REPEAL of the CANNABIS Plant as a "whole"…
When it is freed to the People of this Country, and it is no longer a crime to possess or grow on our own property, or use in our own homes, and the Hemp Farmers are free to grow and sell their Hemp plants AND products, then it can be produced by the Pharma's as a medication and THEIR products can be labeled as "CONTROLLED SUBSTANCES"!
Until then, Pharma should not be allowed to profit, or produce, any Cannabis medications!
The Kentucky Department of Agriculture (KDA) is conducting an Industrial Hemp Research Pilot Program as authorized by KRS 260.850-260.869, and 7 U.S.C.§ 5940 (also known as Section 7606 of the 2014 Farm Bill). Industrial hemp plants, leaf, floral materials, and viable seed materials remain a Schedule I Controlled Substance under state and federal law; no person can grow, handle, broker, or process industrial hemp in Kentucky without a license issued by the KDA. For more information on applications, please visit the Applications for the Hemp Program page. Industrial Hemp is a Controlled Substance and requires a KDA License to Grow, Handle, Process, or Market LINK
Legislative Research: KY SB50 | 2017 | Regular Session
Hemp in Kentucky
CBD/Hemp Oil, Drug War, Latest News	Cannabis, CBD, DEA, FDA, Hemp, legalization, Marijuana, merchant services, Pure Spectrum CBD, Repeal, Repeal Prohibition, USPS
On my end, I am concerned about the control of Cannabis/Hemp and the regulations which will follow legalization and what it means to the prison industrial complex. I am concerned about the right to grow a Cannabis plant in my yard and use it personally for medicine and pleasure. I am concerned about all the children and other people who were so wrongly denied the Cannabis plant since 1937 and be
fore, who so badly needed it as a medication, which was ALREADY IN THE PHARMACOPEIA IN 1900'S, but that the Government pulled out from under them in the name of commerce.
Activists Opinions, Cannabis/Marijuana, CBD/Cannabidiol, Drug War, Latest News, Marijuana & the Law, Patients, ShereeKrider	Cannabis, CBD, DEA, FDA, Hemp, legalization, Marijuana, merchant services, Pure Spectrum CBD, Repeal, Repeal Prohibition, USPS
On my end, I am concerned about the control of Cannabis/Hemp and the regulations which will follow legalization and what it means to the prison industrial complex. I am concerned about the right to grow a Cannabis plant in my yard and use it personally for medicine and pleasure. I am concerned about all the children and other people who were so wrongly
denied the Cannabis plant since 1937 and before, who so badly needed it as a medication, which was ALREADY IN THE PHARMACOPEIA IN 1900'S, but that the Government pulled out from under them in the name of commerce.
Healthcare, Marijuana & the Law	cancer, Cannabis, DEA, FDA, healthcare, Hemp, Marijuana, Right to Try, willing to pay
The 'Right to Try' Could Cost Dying Patients a Fortune
June 20, 2018 Sheree Krider
By Michelle Cortez June 20, 2018,
A small biotechnology company may be the first to offer dying patients unproven drugs under a new U.S. law called Right to Try that deregulated access to such experimental treatments.
But it won't be for free: Brainstorm Cell Therapeutics Inc. would charge for a therapy it is developing for the deadly condition known as Lou Gehrig's disease. While details are still being worked out, the company's chief executive officer pointed to the price of bespoke cell therapies used to treat cancer that cost more than $300,000.
"Companies cannot be NGOs," the nongovernmental organizations that help provide care to impoverished countries, Brainstorm CEO Chaim Lebovits said in a phone interview. "We have to have an incentive."
If it decides to proceed, Brainstorm — a company with no drug on the market yet and no revenue — would introduce a profit motive into an effort many expected to be altruistic, adding more controversy to an already contentious debate. Small drugmakers where much of the innovation in medicine originates can't afford to provide their compounds for free, and terminally ill patients with no other options may be eager to pay for access. There would be little protection for patients already grappling with a tumultuous time in their lives, adding financial risk to the known medical gamble.
Health insurers don't typically pay for treatments that haven't been approved by regulators or proven to work in clinical trials. That means patients would have to pay for the therapies out of their own pockets.
Bypass the FDA
Photographer: Andrew Harrer/Bloomberg
Right to Try, signed by President Donald Trump last month, allows doctors of patients with life-threatening diseases to work directly with drug companies for access to experimental drugs. The law aims to simplify the process and bypass the U.S. Food and Drug Administration almost entirely — its chief sponsor, Republican Senator Ron Johnson, recently put it bluntly, saying the goal was to "diminish the FDA's power over people's lives, not increase it."
Critics said the lack of oversight may make patients even more vulnerable as they near death, creating opportunities for unscrupulous companies or clinics to take advantage of them.
Brainstorm, listed in the U.S. and run from New York and Israel, is trying to address the tension head-on. After requests for access to Brainstorm's NurOwn experimental drug came pouring in following the passage of Right to Try, the company held conference calls with patients and investors to talk through details.
The company's shares were up 2.3 percent to $4.39 at 2:21 p.m., after rising 9.4 percent this year as of Tuesday's close.
Only doctors who participated in the drug's clinical trials would be included in the Right to Try program under consideration at Brainstorm, CEO Lebovits said. It would be a semicommercial enterprise with modest profits that wouldn't exploit patients' desperation, he said. The company, which had operating costs of $5 million last year, would work to obtain funding from foundations or other charitable organizations to help pay for at least one financially strapped patient for every two who are able to pay for it, he said.
NurOwn is being tested for amyotrophic lateral sclerosis, or ALS. The progressive disease erodes nerve cells, weakening the muscles throughout the body and gradually leaving patients unable to walk, speak and breathe.
The Brainstorm treatment is crafted for each individual in a process that includes extracting stem cells from the bone marrow. Its price could be similar to recently approved breakthrough cell therapies known as CAR-Ts, CEO Lebovits said. Those two cancer treatments, also tailored for each patient, cost about $375,000 and $475,000.
NurOwn's mechanism doesn't reverse the underlying cause of ALS, meaning it's unlikely to cure the disease. A mid-stage study involving 48 patients found those given the drug appeared to respond, though the benefit didn't last for most. The final results may not support approval.
Willing to Pay
Still, Matt Bellina, a former Naval officer and proponent of Right to Try, is among almost 1,000 patients hoping to get access to NurOwn. His Lou Gehrig's disease is so advanced that he doesn't qualify for the late-stage study that's underway. So he's willing to pay.
"We all have to do our part," said Bellina, who has gotten positive reports from patients who participated in NurOwn's studies.
Read More: Patient Matt Bellina's fight to help make Right to Try the law
FDA officials declined to comment on Brainstorm's plan, saying the agency plans to convene an internal group to determine how to implement the new law. The office of Senator Johnson didn't have an immediate comment.
Charging for access could create a conundrum for regulators and patients, said Arthur Caplan, director of medical ethics at New York University Langone Medical Center. The law itself doesn't mention pricing and it's not clear if companies can make a profit off unapproved drugs.
"The whole point of this was to weaken the role of the FDA," Caplan said. "It's unclear who would be checking on this."
Lebovits acknowledges the controversy, including the potential that a patient may sink their life savings into a treatment that might not help them. He points out that approved drugs don't help every patient and insists that those who want to try NurOwn would need to be fully informed about the risks before trying it. But he says the decision should be theirs.
"It will be only very educated people who understand the risks they are taking," he said.
(Adds share price in eighth paragraph. An earlier version of this story corrected the CEO's location during an interview.)
Corporate Cannabis, Latest News, Medical Marijuana, PHARMA	Cannabis, Epidiolex, FDA, GW Pharmaceuticals, Hemp, Marijuana
Cannabis, CBD industry wary of looming decision on epilepsy drug
April 15, 2018 Sheree Krider
Published April 9, 2018 | By Kristen Nichols
The most disruptive product to hit the newly legal hemp industry might be one that will never be sold directly to consumers.
GW Pharmaceuticals, a London-based biotech company, is awaiting a final decision from the U.S. Food and Drug Administration to produce the first cannabis-derived treatment to win approval as legal medicine.
The decision on Epidiolex, which treats rare kinds of epilepsy, would be a seminal moment for the cannabis industry, because it would be the first signal from U.S. federal authorities that cannabis has medical value, despite decades of the drug being officially classified as having "no currently accepted medical use."
The FDA has approved some synthetic cannabinoid medicines, but none are produced from the plant, like Epidiolex is.
FDA approval for the drug could trigger an immediate cannabis appeal from the nation's top drug regulators to the U.S. Drug Enforcement Administration, seeking a new classification for the plant that produces marijuana.
That's a change marijuana activists have tried and failed to accomplish since 1972, when drug reformers first appealed the plant's Schedule 1 designation.
The FDA will hold a public hearing on Epidiolex on April 19, with a final decision expected by late June.
'Biggest concern'
If GW Pharmaceuticals, which does business in the United States as Greenwich Biosciences, succeeds where drug-policy reformers have failed for nearly 50 years, you might expect cannabis producers to cheer.
Instead, many are anxious.
FDA approval would send shockwaves through the legal hemp industry, where CBD extraction has created a thriving industry in therapeutic products.
"I would classify this as the biggest concern for the hemp industry," said Jonathan Miller, a lawyer for the U.S. Hemp Roundtable, an industry lobbying group.
The CBD industry fears that FDA approval could trigger a crackdown on CBD products made outside the rules for pharmaceutical production.
The FDA has already designated Epidiolex as an "orphan drug" – a treatment with limited profit potential because the conditions it treats are rare. This designation gives drugmakers exclusive rights to sell their new drug for more than seven years.
That prospect has hemp growers and CBD extractors fearing that FDA approval could mean the end for small hemp extractors.
"There'd be no benefit to the hemp farmers," said Veronica Carpio, a longtime hemp grower and activist in Lafayette, Colorado.
Just another option?
GW Pharmaceuticals insists that FDA approval for Epidiolex won't mean an end to the current market for CBD, a cannabinoid commonly added to foods and personal-care products with no FDA supervision.
"Our objective is not to try to reduce or curtail the use of any other artisanal or dispensary products," GW's Steve Schultz told Hemp Industry Daily.
"Our goal is to provide an additional option, an FDA-approved medicine that physicians and patients desire."
Schultz pointed out that while GW Pharmaceuticals has sought patents for many cannabinoid formulations, the company has no way to stop others from using the CBD molecule itself.
In other words, GW would get exclusive rights to Epidiolex, but not any other formulations.
"You can't get a patent on CBD – it's a naturally occurring molecule," he said.
Hemp activists aren't placated.
Carpio, who heads Grow Hemp Colorado, said FDA approval would set a precedent for CBD dosage – possibly launching a crackdown on concentrated CBD products, such as tinctures promising 1,000 milligrams of CBD.
"They say that they don't want to interfere with the hemp industry or harm us," Carpio said, "but they know there's legislation pending in some states saying that anything that isn't FDA approved won't be allowed.
"That's a monopoly for them."
Embracing CBD standards
Hemp activists and GW Pharmaceuticals agree that the cannabis plant could one day be treated like a vitamin supplement, where some variants are available only by a doctor's prescription, but other formulations are sold over the counter.
"We need to remember that you can get prescription iron supplements, or you can buy iron pills at the grocery store," said Joy Beckerman, president of the Hemp Industries Association.
"We need to fight to maintain this cottage, small-business industry."
Schultz said that cannabinoid treatments could one day be regulated like fish oil, where some formulations must be overseen by a doctor but other formulations are available over the counter.
"There is clearly room for people to be utilizing cannabinoids and cannabis in a variety of ways. We're only looking to provide an option for one way, as a pharmaceutical medicine," Schultz said.
FDA approval for Epidiolex would be far from the end of the story for CBD treatments, as doesn't mean the drugmaker has supplies of the medicine ready to distribute.
Also, there's no guarantee that insurers would cover the drug. GW Pharmaceuticals hasn't said how much Epidiolex would cost.
Many physicians say they want that pharmaceutical option, foretelling a future when they can prescribe marijuana in the form of FDA-approved medicines with regulated dosing and labeling.
"There are many cottage industries that have sprung up to provide CBD. The challenge has always been, what is in those products?" said Dr. Kevin Chapman, a pediatric neurologist at Children's Hospital Colorado.
Chapman specializes in epilepsy and studies cannabis treatments for the condition.
CBD from the cottage market is hard to study because the drug is processed and dosed in so many different ways, Chapman said. For him, Epidiolex approval would be welcome because it would allow doctors to compare results using a standardized CBD product.
Some in the cannabis industry say it's only a matter of time before that standard formulation for CBD enters the market.
The trick, they say, will be to have a product that can be sold outside the pharmaceutical framework and to embrace opportunities in a more heavily regulated marketplace.
"Regulation isn't necessarily a bad thing," said Chris Rebentisch, director of operations for Infused Mfg., a Las Vegas-based company that makes CBD products. "That's what the CBD industry needs more than anything right now."
It's absurd, Rebetisch said, to imagine the cannabis industry shutting down because of some feared crackdown from the FDA.
"We'll pivot and adapt," he said. "We're an industry that could give a rat's ass about federal regulations, right?"
Latest News, Marijuana And The Law	Cannabidiol, Cannabis, CSA, drug scheduling, FDA, Federal, Hemp, Marijuana, Tetrahydrocannabinol, WHO
International Drug Scheduling; … Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; …Cannabidiol; Request for Comments…
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments
A Notice by the Food and Drug Administration on 04/09/2018
This document has a comment period that ends in 13 days. (04/23/2018)
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).
PLEASE FOLLOW THIS ORIGINAL SOURCE LINK TO SUBMIT YOUR COMMENTS…HERE!
Cannabis/Marijuana, CBD/Cannabidiol, Federal Government, FEDERAL LEGISLATION, Hemp, Latest News, Marijuana & the Law	Cannabidiol, Cannabis, CSA, drug scheduling, FDA, Federal, Hemp, Marijuana, Tetrahydrocannabinol, WHO