Category Archives: Health

As the feds crack down on opioid prescriptions, patients are taking their own lives, doctors are losing their jobs and overdose rates continue unabated.

The Government’s Solution To The Opioid     Crisis Feels Like A War To Pain Patients

By Art Levine

Meredith Lawrence's late husband died by suicide after his opioid pain prescription was severely restricted.

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.

Meredith Lawrence sits in the living room of the home in Gainesville, Georgia, that she bought after her husband's death

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, however, 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 addicted.”

“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.”

Anne Fuqua needs exceptionally high doses to manage her pain because of opioid malabsorption.

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 University 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.”

Meredith Lawrence shows the tattoo she got after her husband'€™s death. The bluejay represents her husband, Jay; a cup of cof

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.

CONTINUE READING…

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.

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“Your son is on CBD oil. He is terminated from the clinical trial. Don’t bother ever showing up again,”

13-Year-Old Denied Life-Saving Treatment Because He Used CBD Oil

13-Year-Old Denied Life-Saving Treatment Because He Used CBD Oil

March 5, 2018 By Burgess Powell

Kaden Hartman of Virginia Beach is 13-years-old and lives with Niemann-Pick disease, a condition known colloquially as Child’s Alzheimer’s. There are approximately 500 to 100 cases of diagnosed NPD today, making it extremely rare. Children with Niemann-Pick disease experience rapid physical and mental deterioration. Eventually, they’re faced with seizures and problems with mobility, eating, and communication. According to the National Niemann-Pick Disease Foundation, most children suffering from Child’s Alzheimer’s don’t live to age 20. Kathy Hartman, the mother of this 13-year-old denied life-saving treatment because he used CBD oil, reached out to High Times to explain what happened.

Kaden’s FDA-Approved Treatment

“When there’s nothing else out there to save his life, the FDA will approve an experimental medicine, and he’s been on it for almost three years,” Mrs. Hartman explains.

The drug the FDA approved for Kaden is called Cyclodextrin and has been effectively treating Kaden’s Niemann-Pick disease.

Doctors predicted that Kaden wouldn’t live to age 13, but he’ll be 14 in April.

“It’s definitely working,” says Mrs. Hartman.

In addition to the experimental Cyclodextrin, Kaden has been taking CBD oil since he started experiencing seizures, a common consequence of Niemann-Pick disease.

“It slows down seizures by, I think, 60 percent,” Mrs. Hartman says of CBD after doing research on the non-psychoactive compound of cannabis on her own.

Watching her son experience 10 to 20 seizures daily, Mrs. Hartman decided to give CBD a shot, under the supervision of Kaden’s primary neurologist.

“It seems to be working great,” Mrs. Hartman told Kaden’s neurologist who closely monitored his CBD use.

With CBD, Kaden avoided the negative side-effects associated with anti-seizure medication.

According to Kaden’s mother, the only potential results of CBD use are slight drowsiness and a better appetite.

Going off CBD, however, has had serious consequences.

After Mrs. Hartman received a letter from the Virginia Commonwealth University Medical Center (VCU), the hospital treating Kaden, stating that Kaden will be taken off the study if he uses CBD, she stopped giving him the herbal supplements.

Off CBD, Kaden experiences many seizures. He has since fractured his skull, concussed himself, and developed two blood clots in his brain.

Not only was this 13-year-old denied life-saving treatment because he used CBD oil, but CBD oil itself was a lifesaving treatment for seizures.

Neurologists who work with Niemann-Pick disease patients recommend CBD Oil

In addition to Kaden’s personal experience with CBD’s benefits, two of his neurologists recommended it.

His primary neurologist of 8 years suggested that Kaden take CBD to cope with his seizures.

Dr. Ralph Northam, Kaden’s former pediatrician who is now the governor of Virginia, wrote Kaden a prescription for cannabidiol.

Though Mrs. Hartman didn’t fill out this prescription at the time, it allowed Kaden access to CBD much more potent than the health store variety he later took.

Dr. Rebecca Caffrey, a friend of the Hartman family, explains, “CBD is the drug of choice for treating seizures in NPC kids.”

She cites another case of two young girls who suffer from Niemann-Pick disease and began taking CBD oil to minimize their seizures.

Not only did CBD help these girls—the daughters of Kathy Hartman’s friend Chris Hempel—but they are allowed to continue their other treatment, which is of the same nature as Kaden’s.

Four days after sending Mrs. Hartman that threatening letter, VCU gave her a call.

“Your son is on CBD oil. He is terminated from the clinical trial. Don’t bother ever showing up again,” Mrs. Hartman says, summing up her conversation.

PLEASE CONTINUE READING…

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Kratom-Opioid

For Immediate Release

February 6, 2018

Summary

FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Next, our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).

The new data provides even stronger evidence of kratom compounds’ opioid properties.

The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.

The third aspect of the model is the 3-D image we generate to look at not just where these compounds bind, but how strongly they bind to their biological targets. We found that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

So what does this body of scientific evidence mean? The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance. The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.

Furthermore, this highlights the power of our computational model-based approach to rapidly assess any newly identified natural or synthetic opioids to respond to a public health emergency.

Learnings from reports of death associated with kratom

We’ve been carefully monitoring the use of kratom for several years, and have placed kratom products on import alert to prevent them from entering the country illegally. We have also conducted several product seizures. These actions were based, in part, on a body of academic research, as well as reports we have received, suggesting harm associated with its use. And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions. We described some of this information in a public health advisory in November 2017, in which we urged consumers not to use kratom or any compounds found in the plant.

Now, I’d like to share more information about the tragic reports we have received of additional deaths involving the use of kratom. Looking at the information we have received – including academic research, poison control data, medical examiner reports, social science research and adverse event reports – we now have 44 reported deaths associated with the use of kratom. This is an increase since our November advisory, which noted 36 deaths associated with these products. We’re continuing to review the newly received reports and will release those soon. But it’s important to note that these new reports include information consistent with the previous reports.

Today, we’re releasing the reports of the 36 deaths we referenced in November. These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug. Overall, many of the cases received could not be fully assessed because of limited information provided; however, one new report of death was of particular concern. This individual had no known historical or toxicologic evidence of opioid use, except for kratom. We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide. Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.

However, unlike kratom, FDA-approved drugs have undergone extensive review for safety and efficacy, and the agency continuously tracks safety data for emerging safety risks that were previously unknown. So we have better information about the risks associated with these products; and can better inform the public of new safety concerns. For example, in August 2016, the FDA required a class-wide change to drug labeling to help inform health care providers and patients of the serious risks (including respiratory depression, coma and death) associated with the combined use of certain opioid medications and benzodiazepines. In June 2016, the agency also issued a warning that taking significantly high doses of loperamide, including through abuse or misuse of the product to achieve euphoria or self-treat opioid withdrawal, can cause serious heart problems that can lead to death. We also recently took steps to help reduce abuse of loperamide by requesting packaging restrictions for these products sold “over-the-counter.”

Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s “just a plant” is shortsighted and dangerous. After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.

Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms. We recognize that many people have unmet needs when it comes to treating pain or addiction disorders. For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider. There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We recognize that some patients have tried available therapies, and still have unmet medical needs. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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LIVE! Medicare for All National Town Hall–with Sen. Bernie Sanders!

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Medicare for All National Town Hall

Public

· Hosted by The Young Turks and U.S. Senator Bernie Sanders



Details

With the introduction of the Medicare for All Act last year, Sen. Bernie Sanders and 137 of his colleagues in Congress began the long struggle to end the international embarrassment of the United States being the only major country not to guarantee health care to all its people.

Already, 60 percent of the American people want to expand Medicare to provide health insurance to every one, but many Americans still do not know how a Medicare-for-all, single-payer health care system would work in the United States.

To answer that question and more, Sen. Sanders and leading digital outlets NowThis, ATTN: and The Young Turks are partnering on a groundbreaking Medicare for All Town Hall event January 23 from 7 to 8:30 p.m.

For the first time, leading digital outlets will come together to do what cable channels and network news will not– engage in an in-depth conversation about one of the issues that matter most to Americans, their health care. Streamed live across multiple social media channels, Sen. Sanders and leading health care experts will take questions about Medicare for All from people around the country and discuss how universal health care would change the American system.

Location: Capitol Visitors’ Center Congressional Auditorium (CVC-200)

Seating is first-come, first-served. Please arrive early to ensure a seat. No posters or signs will be permitted. ASL interpreters will be present at the event.

SOURCE LINK

https://www.facebook.com/events/923471961163492/

https://www.sanders.senate.gov/download/medicare-for-all-act?id=6CA2351C-6EAE-4A11-BBE4-CE07984813C8&download=1&inline=file

We the undersigned, Americans who join the millions of our fellow citizens who responsibly use the botanical plant kratom…

CONTINUE OUR VIRTUAL
MARCH ON WASHINGTON
DAY TWO
PLEASE CO-SIGN OUR
OPEN LETTER TO ROBERT W. PATTERSON

ACTING DIRECTOR, U.S. DRUG ENFORCEMENT ADMINISTRATION

Please Sign Letter Here

Dear Administrator Patterson,
We the undersigned, Americans who join the millions of our fellow citizens who responsibly use the botanical plant kratom as a part of our health and well-being regimens, join the American Kratom Association (AKA) in strongly urging the Drug Enforcement Administration (DEA) to conduct a thorough and independent 8-Factor Analysis on kratom to test the credibility of the scheduling recommendation submitted by the US Food and Drug Administration (FDA).
In its enactment of the Controlled Substances Act, Congress has wisely required the DEA to do its own independent review on scheduling recommendations submitted by the FDA to provide a 2nd opinion on important substance scheduling issues.  That 2nd opinion is desperately needed in the evaluation of kratom because the science directly refutes the FDA claims.
Specifically, we respectfully ask the DEA to carefully examine the following issues in its own 8-Factor Analysis on kratom:

  • Kratom is a safe botanical that does not kill people.  The deaths the FDA claims are caused by kratom are actually fatalities associated with underlying health issues of the decedent, or caused by the use of other toxic doses of substances that are co-administered or mixed with kratom. Kratom has a long history of safe use over centuries when responsibly consumed, and the FDA claims are simply unsupportable based on the science.
  • If kratom is banned, opioid deaths will increase.  The opioid crisis in America kills more than 90 people every day.  Credible studies show that many people manage pain using kratom as an alternative to dangerously addictive and potentially deadly prescription opioids.  If it is banned, those people will be forced to opioid use, or to the black market for products that are contaminated or adulterated, and therefore very dangerous.  The perverse public health outcome from any ban on kratom will result in more deaths.
  • Kratom is an alternative to opioids, not a gateway to opioid abuse.  Kratom does not produce a high like opioids; kratom does not suppress the respiratory system like opioids; and kratom does not produce opioid-like effects.  Kratom is safely and responsibly used by millions of Americans, including some for alleviating pain. Without kratom, many will be forced to opioid use to alleviate pain.
  • The AKA, and we agree, strongly supports appropriate FDA regulations to protect consumers.  Protecting consumers from adulterated and contaminated kratom products; assuring children cannot purchase or consume kratom; imposing good manufacturing standards to ensure product purity; product packaging standards to prevent tampering; and clear labeling and health claims restrictions similar to other dietary supplement products, are important roles for the FDA to have in protecting consumer safety, and we welcome such restrictions to ensure continued safe and responsible use of kratom products by consumers.

The DEA has received an independent 8-Factor Analysis on kratom authored by one of the leading experts on addiction and substance safety, Jack Henningfield, Ph.D., and we believe that data will be critically important to the DEA’s own analysis of kratom.  In addition, there are four other key studies on kratom use that the DEA should consider that clearly demonstrate the harm that will be done by any scheduling order on kratom.
Respectfully submitted,

Please Sign Letter Here

FDA News Release FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

For Immediate Release

November 1, 2017

Release

As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products’ ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

Unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. The FDA has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE LINK / CONTINUE READING…

RE: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments

The information contained herein is from the Government website of REGULATIONS.GOV.

They are currently seeking comments on the scheduling of the above named substances.  After browsing through the information I did not see CANNABIS included in this request.

 Cannabidiol, IS INCLUDED. 

I will submit my comments and will post my response here on the website.

Image result for psychotropic substances

Summary

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 17 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).

Dates

Submit either electronic or written comments by September 13, 2017.

Supplementary Information

I. Background

The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

Section 201 of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

Links to further information and to post comments:

Docket ID: FDA-2017-N-4515

Agency: Food and Drug Administration (FDA)

Parent Agency: Department of Health and Human Services (HHS)

*View all documents and comments in this Docket

*Public Comments that have already been received and posted.

*SUBMIT YOUR COMMENT THROUGH THIS LINK

*LINK TO DOCUMENTATION IN THE FEDERAL REGISTER

The DEA doesn’t see it as legal’ and that’s where he gets his medical license.”

FOX Files: Some doctors fear following Missouri’s medical marijuana law

Posted 11:15 pm, February 21, 2017, by Chris Hayes

ST. LOUIS, MO (KTVI)- A form of medical marijuana may be legal in Missouri, but patients are finding doctors afraid to even discuss it. It’s called CBD hemp oil, extracted from a type of marijuana that cannot get you high. It’s now legal in Missouri for treating intractable epilepsy, but families say some doctors are afraid to honor the new law.

Robert Tufts,  11, says it hurts when he seizes.

“It just feels like some sort of shock like, my brain, inside my head. I’ll just get a little fuzzy feeling and I’ll shake and I’ll be dizzy for a second.”

He takes a handful of pills he says sometimes make him feel worse.

“It just felt like I was so enraged and wanted to break everything.”

His mom, Stephanie, thinks CBD oil could be a better way, but she can’t convince her son’s doctor.

“His exact words to me were, ‘It’s not legal,’” said Stephanie Tufts.  “I said well the oil is legal here in Missouri and he basically came back with, ‘It’s not. The DEA doesn’t see it as legal’ and that’s where he gets his medical license.”

FOX 2 has learned only 66 families in Missouri have obtained medical cards to buy CBD oil, with potentially thousands of families asking for it.

Treasurer Eric Schmitt fought for the new law when he was State Senator.

“This idea that you’ve tried everything and it’s not working, but there may be something that is now legal in the State of Missouri to now possess and use and that a doctor and a hospital would not allow families to access that – there’s no excuse for it,” said Schmitt.

Schmitt has met with hospital administrators across the State trying to get them to reconsider.

“I know for a fact that there are neurologists in those hospital systems that want to be able to recommend, but are not being allowed to by the lawyers. And I think that that’s just…it’s unconscionable.”

There is one hospital working with patients.  It’s in St. Louis, SSM Health Cardinal Glennon Children’s Hospital.

Dr. Sean Goretzke with SSM said, “Even though there might be some negatives and some side effects, (we felt) there was a certain percentage of patients that we owed it to to do everything we could to try to help within a safe and reasonable effort.”

Dr. Goretzke is director of child neurology at SSM Health Cardinal Glennon Children’s Hospital.

“Cases where this works are really highly publicized. There’s a lot of social media attraction to it and those are great and we’re happy about those. But we know this isn’t going to work for every patient, just like every other medicine we have.”

Patients must first try three traditional prescriptions without success.  The marijuana strain that’s cultivated for its CBD oils does not contain the psychoactive THC, which hurts brain development, but Dr. Goretzke says there’s no research to answer whether CBD oil could still present risks.

“The majority of kids we are treating with this substance are so delayed from the burden of their seizures, maybe from the side effects of their other medications, that we feel the potential benefit for this medicine far outweighs those risks,. But with a typically developing child we’re still just not quite sure yet.”

He acknowledged they must start somewhere, but said it would help if there was research money to help answer their concerns.  Dr. Goretzke also said this is not a mandate and the hospital will respect individual doctors who might not want to be part of it.

Follow Fox 2’s Chris Hayes on Facebook https://www.facebook.com/ChrisHayesTV/

Follow Fox 2’s Chris Hayes on Twitter @ChrisHayesTV

CONTINIUE READING…

The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017)

THE NATIONAL ACADEMIES PRESS HAS RELEASED A NEW RESEARCH BOOK REGARDING THE HEALTH EFFECTS OF CANNABIS.  PLEASE USE LINK PROVIDED TO REVIEW.

 

The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research

 

Description

Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk.

However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.

Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agenda—outlining gaps in current knowledge and opportunities for providing additional insight into these issues—that summarizes and prioritizes pressing research needs.

Topics

 

CONCLUSIONS FOR: THERAPEUTIC EFFECTS
There is conclusive or substantial evidence that cannabis or cannabinoids are effective:
• For the treatment for chronic pain in adults (cannabis) (4-1)
• Antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids) (4-3)
• For improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
There is moderate evidence that cannabis or cannabinoids are effective for:
• Improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea
syndrome, fibromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols) (4-19)
There is limited evidence that cannabis or cannabinoids are effective for:
• Increasing appetite and decreasing weight loss associated with HIV/AIDS (cannabis and oral cannabinoids) (4-4a)
• Improving clinician-measured multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
• Improving symptoms of Tourette syndrome (THC capsules) (4-8)
• Improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol)
(4-17)
• Improving symptoms of posttraumatic stress disorder (nabilone; one single, small fair-quality trial) (4-20)
There is limited evidence of a statistical association between cannabinoids and:
• Better outcomes (i.e., mortality, disability) after a traumatic brain injury or intracranial hemorrhage (4-15)
There is limited evidence that cannabis or cannabinoids are ineffective for:
• Improving symptoms associated with dementia (cannabinoids) (4-13)
• Improving intraocular pressure associated with glaucoma (cannabinoids) (4-14)
• Reducing depressive symptoms in individuals with chronic pain or multiple sclerosis (nabiximols, dronabinol, and nabilone)
(4-18)

PLEASE CONTINUE TO LINK HERE

New DEA Rule Says CBD Oil is Really, Truly, No-Joke Illegal

Bruce Barcott

December 14, 2016

The US Drug Enforcement Administration (DEA) this morning made CBD oil a little more federally illegal in a little-noticed bureaucratic maneuver this morning.

Today’s Federal Register (Dec. 14, 2016) contains an item (21 CFR Part 1308) that establishes a new drug code for “marihuana extract.”

“This code,” wrote DEA Acting Administrator Chuck Rosenberg, “will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana.” The move, the Register entry explained, is meant to bring the US into compliance with international drug-control treaties.

There is no major change in law brought about by the Register item. Rather, it serves to clarify and reinforce the DEA’s position on all cannabis extracts, including CBD oil. That position is: They are all federally illegal Schedule I substances.

CBD oil derived from hemp is now commonly available nationwide via web sites and mail order services. Those operations survive on the assumption that cannabidiol products below the legal threshold for THC percentage in hemp (0.3 percent or less) are technically legal.

Not so, says the DEA.

In the DEA comment on the entry, Rosenberg directly addressed the question: What if it’s only cannabidiol (CBD) and no other cannabinoids? The agency’s response: “For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code” and therefore remain federally illegal. In other words: The DEA is confident that it can find enough traces of other cannabinoids in your CBD oil to arrest and prosecute. And if they can’t, they still have the option of arresting and prosecuting based on the CBD oil itself.

RELATED STORY

Is CBD from Cannabis the Same as CBD from Cannabis?

Is your CBD derived from hemp? Doesn’t matter to the DEA. The new extracts classification applies to all “extracts that have been derived from any plant of the genus Cannabis and which contain cannabinols and cannabidiols.” Hemp is not a separate genus. (Although it may be a separate species; lot of debate on that point.) Legally speaking, hemp is simply cannabis with no more than 0.3 percent THC content.

The new rule seems to clarify the DEA’s position on hemp-derived CBD, which entered a legal gray area following Congress’ passage of the 2014 farm bill. That legislation allowed certain states to grow hemp in pilot projects, and blocked federal law enforcement authorities (ie, the DEA) from interfering with state agencies, hemp growers, and agricultural research.

What DEA Administrator Rosenberg seems to be saying with this clarification is: You may be able to grow hemp. But if you try to extract CBD oil from it, the DEA considers that a federal crime.

The rule did not contain any hint as to when the DEA will step into the 21st century and stop using the archaic version of the word “marihuana.”

Lead Image: Brennan Linsley/AP

CONTINUE READING…