Tag Archives: FDA

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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What Is Legal and What Is Not??? “I was arrested for multiple felonies…in KNOX County Tennessee for possessing Industrial Hemp”

Pure Spectrum Video

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 Laughing out loud 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…”

PureSpectrum-BradyBell

PureSpectrum-BradyBell2

And so it begins…

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  

No automatic alt text available.



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!

smk

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

International Drug Scheduling; … Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; …Cannabidiol; Request for Comments…

plant

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!

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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Wisconsin’s Governor wants to disqualify weed smokers from welfare

  • Steve Elliott
  • Comments302
  • 15 December, 2017
  • Wisconsins Gov. Scott Walker Wants To Drug Test People On Welfare 2 of 3 800x400 Wisconsins Governor wants to disqualify weed smokers from welfare

    ABOVE:  NEW YORK, NY – DECEMBER 11: A Harlem resident chooses free groceries at the Food Bank For New York City on December 11, 2013 in New York City. The food bank distributes dry, canned and fresh food to needy residents and works with community based member programs to provide some 400,000 free meals per day throughout the city. Need increased in November when 47 million low-income people nationwide saw their food stamps cut as the federal SNAP program expired. (Photo by John Moore/Getty Images)

    Wisconsin Governor Scott Walker believes that poor people who receive public assistance should have to undergo drug testing, and he’s taking steps to make sure that happens.

    Walker last week charged ahead with a plan to require drug testing for some recipients of Wisconsin’s food stamps program, formally referred to as the Supplemental Nutrition Assistance Program (SNAP), reports The Atlantic. The plan would make Wisconsin the first state in the union to drug test for food stamps, other states that have tried the move have been blocked by the feds.

    That comes on top of another plan to test Medicaid enrollees in Wisconsin. Oh, and don’t forget a law already on the books: That one requires drug testing for non-custodial parents getting funds Temporary Assistance for Needy Families.

    If Gov. Walker’s proposals pass federal scrutiny, all three of the major welfare programs in Wisconsin will involve drug-testing the recipients. Walker’s move to “overhaul welfare” over the past three years has already included some such “reforms.”

    The proposed change to SNAP would affect those who take part in its Employment and Training Program (ETP). Healthy, childless adults already have to meet work requirements to qualify for food stamps through ETP.

    Under Gov. Scott’s proposed new rules, those who test positive would be required to undergo drug treatment, or lose their benefits. The state would pay for “drug rehab” for pot smokers who couldn’t afford to pay for it themselves.

    While alcohol, amphetamines, cocaine, and barbiturates all clear out of a person’s urine after four days or so, marijuana can linger for 30 days or more. That means any drug testing, by definition, tends to catch more cannabis smokers than any other category of substance user.

    Arizona has published figures showing a net savings of just $3,500 for 26 individuals who either tested positive or failed to show up for their drug test appointment. That’s an overall saving of just $135 per person.

    According to state data, the seven states with existing programs— Arizona, Kansas, Mississippi, Missouri, Oklahoma, Tennessee, and Utah— are spending hundreds of thousands of dollars to detect very few drug users. The statistics show that welfare applicants actually test positive at a lower rate for drug use than does the general population.

    Meanwhile, the states have collectively spent almost $1 million on the effort, with millions more slated to be spent in years to come.

    Under the Obama Administration, Gov. Walker’s requests to add drug testing in the SNAP program were denied or delayed by the Agriculture Department because they were seen as an additional barrier to eligibility— one that Wisconsin wasn’t entitled to impose.

    While the state denied that, the argument had already been used successfully. The Centers for Medicare and Medicaid Services has also denied requests for waivers from states which wanted to impose drug testing for Medicaid.

    Early on, Centers for Medicare and Medicaid Services Administrator Seems Verma signaled the agency would now accept work requirements in Medicaid waivers, like the one being considered in Wisconsin. Verma also announced in November that CMS “will approve proposals that promote community-engagement activities,” typically including work, community service, and job training.

    According to Kaiser Health News, healthcare experts expect this move heralds the agency’s support for further conservative reforms impacting aid eligibility such as drug testing. Advocates are concerned the changes are just a way for states to kick millions of poor people off welfare programs, and undermine their mission of providing food assistance and health coverage to the poor.

    PLEASE CONTINUE READING…

    "It’s the height of hypocrisy,"…

    FDA Is Open To Medical Marijuana For Vets, But Other Agencies Stand In The Way

    Mona Zhang , Contributor

    Dr. Sue Sisley, a medical marijuana researcher, speaks at the Arizona Secretary of State’s Office Wednesday, April 14, 2010 at the Capitol in Phoenix. (AP Photo/Matt York)

    When the U.S. Food and Drug Administration (FDA) warned cannabidiol producers against making medical claims about cannabis products, it seemed par for the course for any federal agency. Cannabis is simply not considered medicine in the eyes of the government.

    But the FDA actually appears pretty open to considering the potential of marijuana as medicine. “We’ve had good experiences working with the FDA,” said Brad Burge, communications director at the Multidisciplinary Association for Psychedelic Studies (MAPS). The non-profit is currently conducting the first FDA- and DEA-approved clinical trial on whole-plant marijuana and enrolled its 30th participant on October 26.

    “We have a long relationship with the FDA — a lot through our MDMA research. They’ve been open to approving research protocols into Schedule I drugs,” said Burge. “It’s other regulatory agencies that have been standing in the way.”

    It’s certainly unhelpful that the National Institutes of Drug Abuse have a monopoly on growing research cannabis. The Drug Enforcement Administration and the Justice Department aren’t helpful on this front either. But the lack of support for the study from Veterans Affairs (VA) is even more egregious.

    Dr. Sue Sisley, the trial’s lead researcher, says she’s determined to focus on veterans for this study. She plans to examine the effects of cannabis on 76 subjects with treatment-resistant PTSD. Her main motivation in focusing on veterans is the epidemic of veteran suicides in the U.S. The VA estimates that about 22 veterans commit suicide every day – Sisley thinks that number is probably higher.

    “As a scientist, I’m skeptical of subjective claims,” said Sisley. “[But] we have a mountain of anecdotal reports from veterans claiming that cannabis is lifesaving.”

    The implications go beyond saving their lives – Sisley has heard plenty of military spouses and children sing the praises of the drug. “The kids will say, ‘I got my dad back’ after years of [him] being disengaged, irritable and mean,” she said.

    Now, her main challenge is recruiting enough veterans who fit the study criteria and are able to participate on-site in Phoenix, Arizona. Sisley estimates that the Phoenix VA hospital has 20,000 veterans in their system who meet the study’s eligibility requirements. But the hospital is refusing to provide information about the study to its patients.

    “[In] some of the states that have put in appropriate controls [for medical marijuana], there may be some evidence that this is beginning to be helpful,” said VA Secretary David Shulkin at a White House press briefing in May. “We’re interested in looking at that and learning from that.”

    But Sisley says that Shulkin has so far refused to express support for her study: “It’s the height of hypocrisy,” she said.

    “The VA Secretary could make a call to the Phoenix VA, and we could start sharing information with these patients,” said Sisley. “Why does it take political courage to defend a federally legal study? Not even defend it, just fast-track it. We’ve been stonewalled at every turn.”

    The researchers have paid for various types of advertising and hired a veteran to oversee recruitment efforts. Still, “the issue for us is [getting] cooperation from the Phoenix VA hospital,” said Sisley. Recruitment has dwindled to a “pretty slow trickle.”

    If the study fails to recruit 46 more veterans in the next couple of months, “we’ll have to reevaluate,” she said. “We fought for so many years and the veteran community has stood shoulder to shoulder with us, helping us kick down the doors… Many of them have adopted this trial as their own.”

    The American Legion, a veterans organization that has more than 2 million members, called on the VA to support the clinical trial in September. “We ask for your direct involvement to ensure this critical research is fully enabled,” wrote the organization’s National Commander Denis Rohan in a letter to Shulkin. “[The study] could potentially produce scientific evidence that will enhance, improve, and save the lives of veterans suffering from post-traumatic stress disorder.”

    But Shulkin has remained mum on the issue.

    “I’m assuming that [Attorney General] Sessions has created an atmosphere of fear around the word ‘cannabis’ and so nobody’s willing to step out,” said Sisley. “The FDA deserves major commendation because they at least are responsive.”

    CONTINUE READING…

    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.

    ###

    SOURCE LINK / CONTINUE READING…

    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy.

    Image may contain: 1 person, plant, nature and outdoor

    Kratom Advocates:

    If you’ve had one of those days that starts with friends calling you with bad news, and the news just gets worse and worse as the day goes on – then that describes my day perfectly.

    On Friday of last week, Sen. Chuck Grassley of Iowa, and Sen. Dianne Feinstein of California, dropped a bill in the U.S. Senate that our lobbyists believe will give the FDA and DEA a backdoor way of banning kratom completely in the United States.

    S. 1327 is euphemistically called the SITSA Act.  And a companion bill in the US House of Representatives has already been filed, H.R. 2851, by Representative John Katco of New York.

    The SITSA Act stands for the “Stop Importation and Trafficking of Synthetic Analogues Act of 2017.”
    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy.

    That is kratom. Because kratom’s 2 primary alkaloids, mitragynine and 7-hydroxymitragynine, though not opioids, act similarly in some ways.
    They could of just called this bill the “Schedule Kratom” Act.

    This legislation will allow the Attorney General, and his supporters at the DEA, to add kratom to Schedule A on a “temporary basis” that will last for 5 years.
    And once added to Schedule A, the Attorney General can convert it to a permanent schedule.
    After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.

    Under the current Controlled Substances Act, the FDA and DEA have to prove conclusively that kratom is dangerously addictive and unsafe for consumer use. That’s why we were able to stop them in their tracks when they tried to ram through an “emergency scheduling” ban on kratom.

    And it is why the FDA is having such a tough time in finding some justification to schedule kratom under regular rulemaking.

    So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an “analogue” of the opioid.

    And the SITSA Act can enforce a ban on kratom by criminalizing any manufacturer or distributor of kratom. Ten years imprisonment just for manufacturing or selling a kratom product, and a fine of $500,000 if you are an individual, $2,500,000 if the defendant is a company.

    If you import or export kratom, it is a 20-year sentence.

    And then there are harsh penalties for what they call “false labeling” of a Schedule A substance.
    That’s why am writing – because I need your help again.

    We have to convince Sen. Grassley, Sen. Feinstein, and Representative Katko that they have to exempt natural botanical plants from the SITSA Act.
    We have to act quickly, because I learned today that the House Judiciary Committee is looking to schedule a Hearing before they leave for recess next month.

    So I hope you will help by doing three specific things:

    1.    Click on the link below and sign our petition that the AKA will have delivered to every member of the Senate and House Judiciary Committees. 

    PLEASE SIGN THIS PETITION URGING LAWMAKERS TO REMOVE KRATOM FROM THE SITSA ACT.

    2.    I need you to pick up the phone and call Sen. Grassley’s office, Sen. Feinstein’s office, and Representative Katco’s office. When the staff member answers the phone, tell them that their boss should exclude natural botanicals like kratom products from the SITSA Act.

    Here are the phone numbers you should call:

    Senator Grassley:    (202) 224-3744
    Senator Feinstein:    (202) 224-3841
    Congressman Katco:    (202) 225-3701

    When you call, be polite, but firm.  Kratom should be exempted from SITSA.

    3.    Please click on the donation link below and help us once again to take on this fight with a team of lawyers, lobbyists, and public relations professionals.  Please consider making a monthly contribution to the AKA.

    DONATION LINK TO HELP THE AKA FIGHT THIS LEGISLATION.

    I know I am asking a lot.

    But we need to fight back hard, or they will steal our freedoms from us to make our own decisions about our health and well-being.

    So please, sign the petition, call the the sponsors of SITSA, and please, please, give as generous a contribution as you can to help us put our team on the ground in Washington, D.C.

    With your help, we have established ourselves as a real force in Washington.

    With your continued help – help that I am so grateful for – we can win this battle against the enemies of kratom.

    Your contribution will help us hire the lawyers we need for a brief on why this legislation violates due process and current law; our lobbyists to knock on doors on Capitol Hill; and our public relations team to rally the press to tell our story.

    We will stand up for freedom.

    Thank you for your continued support.

    Sincerely,

    Susan Ash
    Founder and Spokesperson
    American Kratom Association
    www.americankratom.org

    http://mailchi.mp/americankratom/new-legislative-attack-on-kratom?e=2709219685

    https://www.facebook.com/kratom.us/photos/rpp.260289027341069/873568049346494/?type=3&theater

    The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom

    11/30/2016 04:03 am ET

    Those who use and study the plant say an outright ban could do serious harm.

    Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

    The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

    With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

    But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

    The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

    “We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

    Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

    The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

    “Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

    The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

    Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

    Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

    “As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

    But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

    “Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

    CONTINUE READING…

    The DEA is withdrawing a proposal to ban another plant after the Internet got really mad

    By Christopher Ingraham October 12 at 10:42 AM

    The Drug Enforcement Administration is reversing a widely criticized decision that would have banned the use of kratom, a plant that researchers say could help mitigate the effects of the opioid epidemic.

    Citing the public outcry and a need to obtain more research, the DEA is withdrawing its notice of intent to ban the drug, according to a preliminary document that will be posted to the Federal Register Thursday.

    The move is “shocking,” according to John Hudak, who studies drug policy at the Brookings Institution. “The DEA is not one to second-guess itself, no matter what the facts are.”

    The DEA had announced in August that it planned to place kratom in schedule 1 of the Controlled Substances Act, the most restrictive regulatory category, as soon as Sept. 30. But since announcing their intent to ban kratom, the “DEA has received numerous comments from members of the public challenging the scheduling action,” acting administrator Chuck Rosenberg wrote in the notice, “and requesting that the agency consider those comments and accompanying information before taking further action.”

    A spokesman for the Drug Enforcement Administration did not immediately respond to requests for comment.

    [What it’s like to be high on kratom, according to the people who use it]

    Kratom is a plant from southeast Asia that’s related to coffee. It contains a number of chemical compounds that produce effects similar to opiates when ingested.

    People who take it have have said kratom helped them overcome addiction to opiates or alcohol and treat otherwise intractable pain. Researchers say that their work with kratom could eventually lead to the development of nonaddictive alternatives to powerful opiate painkillers. Placing kratom in schedule 1 would cripple researchers ability to study the drug, they say.

    U.S. lawmakers were among the groups expressing their displeasure with the DEA’s intent to ban kratom. A group of 51 U.S. representatives wrote to the DEA saying that the DEA’s move “threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community.”

    Another group of nine senators said the DEA’s “use of this emergency authority for a natural substance is unprecedented,” and urged the administration to reconsider.

    The DEA will now open up a period for public comment until Dec. 1 of this year. It is also asking the FDA to expedite a “scientific and medical evaluation and scheduling recommendation” for the active chemical compounds in kratom.

    At the close of the comment period, a number of things could happen. The DEA could decide to permanently place the plant in a schedule of the Controlled Substances Act, which would require an additional period for lawmakers and the public to weigh in. It could also decide to temporarily schedule kratom, which would not require any additional comment.

    It could also decide to leave kratom unregulated.

    [Police arrest more people for marijuana use than for all violent crimes — combined]

    Advocates for kratom use, who say the plant has helped them treat pain and stop taking more powerful and deadly opiate painkillers said they are elated.

    “I am in tears,” Susan Ash of the American Kratom Association said in an email. “Our voices are being heard, but we still have a long road ahead of us.

    Lawmakers who criticized the initial announcement to ban kratom are also pleased. “Concerned citizens across the country have made it clear, they want the DEA to listen to the science when it comes to the potentially life-saving properties of kratom,” said Mark Pocan (D.-Wis.) in an email.

    Researchers are welcoming the move, but they point out that the future of their work with the plant is an uncertain one.

    “It’s certainly a positive development,” said Andrew Kruegel of Columbia University in an email. Kruegel is one of the researchers working to develop next-generation painkillers based on compounds contained in kratom.

    Kruegel says that the FDA’s evaluation of the drug will carry a lot of weight in the DEA’s decision. But the kind of rigorous, controlled trials that the FDA typically refers to in situations like this simply don’t exist for kratom.

    “Unfortunately, in the United States I don’t think we have a good regulatory framework for handling this situation or taking perhaps more reasonable middle paths” between banning the drug outright or keeping it unregulated, Kruegel says.

    Still, he says, “the FDA is a scientific agency rather than a law enforcement agency, so I am encouraged that they will now be having more serious input on this important policy decision.”

    Marc Swogger, a clinical psychologist at the University of Rochester Medical Center who has published research on kratom use and earlier called the decision to ban the plant “insane,” said in an email that “I’m happy to see this. It is a step in the right direction and a credit to people who have spoken out against scheduling this plant.”

    CONTINUE READING…