FTC Sues Drug Makers for Oxymorphone Monopoly

By Pat Anson, PNN Editor

It was in 2017 that Endo Pharmaceuticals – under pressure from the Food and Drug Administration -- stopped selling Opana ER, an extended-release version of the opioid painkiller oxymorphone. Opana had been reformulated by Endo to make it harder to abuse, but the FDA maintained the tablets were still being crushed, liquefied and then injected by illicit drug users.

Although Opana has been off the market for nearly four years, a legal battle still rages over sales of generic oxymorphone and whether Endo conspired with another drug maker to control the market for oxymorphone.

This week the Federal Trade Commission sued Endo, Impax Laboratories, and Impax’s owner, Amneal Pharmaceuticals, alleging that a 2017 agreement between Endo and Impax violated antitrust laws by eliminating competition for oxymorphone ER.

It’s the second time the FTC filed complaints against Endo, Impax and Amneal for allegedly creating an oxymorphone monopoly.

“The agreement between Endo and Impax has eliminated the incentive for competition, which drives affordable prices,” Gail Levine, Deputy Director of the FTC’s Bureau of Competition said in a statement. “By keeping competitors off the market, the agreement lets Impax continue to charge monopoly prices while Endo and Impax split the monopoly profits.”

According to the FTC complaint, Opana ER generated nearly $160 million in revenue for Endo in 2016 and was the company’s “highest-grossing branded pain management drug.” Endo explored bringing another oxymorphone drug on the market to replace its lost revenue, but ultimately decided to partner with Impax, which had the only extended-release oxymorphone drug on the market.. Their agreement allowed Endo to share in Impax’s oxymorphone profits, as long as Endo did not bring another generic tablet on the market.

“The purpose and effect of the 2017 Agreement is to ensure that Endo, the gatekeeper to competition in the oxymorphone ER market, has every incentive to preserve Impax’s monopoly. By doing so, it eliminates any potential for oxymorphone ER competition, allowing Endo and Impax to share in the monopoly profits. As a result, patients have been denied the benefits of competition, forcing them and other purchasers to pay millions of dollars a year more for this medication,” the FTC complaint alleges.

The 2017 agreement between Endo and Impax arose from a breach of contract case relating to a patent settlement between the companies over Impax’s generic version of Opana ER, in which Endo paid Impax more than $112 million not to compete. In 2019, the FTC ruled that settlement was an illegal "pay-to-delay" agreement.  

Both Endo and Amneal deny there was any effort to create a monopoly in their 2017 agreement.

“It is Endo’s position that the Agreement had no adverse impact on actual or potential competition.  At the time of the Agreement, the U.S. Food and Drug Administration had asked Endo to withdraw reformulated Opana ER from the market for safety reasons and Endo had publicly announced its intention to comply with the FDA’s request,” Matthew Maletta, Endo’s Executive Vice President and Chief Legal Officer, said in a statement to PNN.

“Significantly, as Endo has explained to the FTC, the Company has not launched or licensed any new opioid product(s) since that time, and the FTC’s theory that Endo would do so in the current litigation environment but for the Agreement is preposterous.”

“Far from being anticompetitive, the 2017 Amendment resolved a dispute between the parties that could have kept Impax's lower-priced generic product off the market entirely,” Amneal said in a statement. “We are confident there is no unlawful restraint in the 2017 Amendment, because nothing in the agreement prevents Endo from competing, and we intend to vigorously defend against the FTC’s claims.”

The FTC decision to sue Endo and Amneal a second time was approved on a split 3 to 2 vote by the agency’s commission. The complaint seeks monetary relief and a permanent injunction to prohibit the companies from engaging in similar conduct.

Extended-released oxymorphone is approved for the treatment of moderate to severe pain.  

Contact Congress to Make Changes in Federal Pain Study

By Richard Lawhern, PNN Contributor

On January 20, I sent a letter by email to the Acting Director and senior staff of the Agency for Healthcare Research and Quality (AHRQ).  The letter requests the federal agency to immediately withdraw its recent review of prescription opioids and other treatments for short-term acute pain. 

Grounds for the request are clear evidence of unjustified anti-opioid bias by the authors and gross fatal errors of methodology – all of which invalidate the review as resource material for efforts to revise and expand the 2016 CDC opioid guideline.

The anti-opioid bias of Roger Chou and his co-authors is revealed by their selective cherry-picking of references that fail to explore the major effects of genetics in patient response to opioid therapy, as well as improperly generalized findings based on trials of weak opioids like tramadol, which were applied to all opioids.

The AHRQ authors also omit any exploration of serious side effects and mortality caused by non-opioid treatments such at acetaminophen.

But the most fundamental error in the methods of the AHRQ Review is improper use of “meta-analysis” to lump together data and outcomes from multiple small-scale studies of opioid therapy for acute pain. A major underlying assumption of meta-analysis is that patient response in each trial is distributed on a Normal (bell-shaped) curve. However, this assumption doesn’t work for patients treated with prescription opioids.

The distribution of patient outcomes is actually “bi-modal.” One group of patients may experience side effects from opioids, but very little short-term pain relief; while a second group may have substantial pain relief from just one dose of opioid medication. This reality invalidates the major findings of the AHRQ review.

A detailed critique of the AHRQ study is available on my website. Feel free to review and share this information with your personal physician.

AHRQ is fully aware of the errors noted above but has no intention of responding to demands for a correction of its malfeasance and fraud.  Thus, it may be necessary for the U.S. House Government Oversight and Reform Committee to direct AHRQ to withdraw or rewrite its review. 

Such an action has precedents.  In 2015, the Oversight Committee reviewed complaints from the Washington Legal Foundation and others concerning inadequate public hearings on the CDC’s proposed opioid guideline. The committee sent a letter to then-CDC Director Thomas Frieden asking him to explain why so much secrecy was involved in the drafting of guideline and why it wasn’t made publicly available.

Faced with a congressional inquiry, CDC reversed course by delaying the guideline’s release and publishing the draft in the Federal Register for a 30-day public comment period. A new advisory committee was also formed to review the guideline, which resulted in some changes to its final recommendations.

Urgent Action Request

A similar effort is urgently needed by pain sufferers and their advocates to bring the AHRQ review to the attention of Congress, specifically to the House Government Oversight and Reform Committee. Those who wish to involve the committee in corrective action should telephone any or all of the Congressional offices of committee members. 

It is very doubtful that the representatives will actually see anything you leave in their contact portals online. But short, focused telephone calls are harder to ignore. The telephone numbers for members of the House Committee can be found here. If you reach a staff member in their office, you might offer the following information:

1) Identify yourself and provide a call-back number. If you are a medical professional, state your qualifications (i.e. “I am a board certified physician” or “I am a former nursing professional now disabled by agonizing pain.”)

2) If you are a resident of the Representative’s district, say so. You don’t have to be a constituent to make your input.

3) Tell the staffer that you want to report fraud and abuse to the Representative and to the House Congressional Oversight and Reform Committee. 

“I want the Committee to demand corrective action from the Agency for Healthcare Research and Quality, in the same way it did in 2015 when it told the CDC to re-open its proposed opioid guideline to extended public review.”

“AHRQ published a review of treatments for acute pain in December 2020. The review is deliberately biased against the only therapies that work, deeply flawed by errors of scientific method, and outright fraudulent in its conclusions. This review must be withdrawn for independent review.”

4)  Thank the staffer for their time.  Ask “May I expect a callback from a member of the Representative’s staff?”

This is an opportunity to be heard, despite the lies being shouted by anti-opioid fringe groups like Physicians for Responsible Opioid Prescribing (PROP) and Shatterproof.

It is time for you to speak up!

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Finding Grace in Family-Induced Pain and Trauma

By Cynthia Toussaint, PNN Columnist

About 20 years ago, my mother called to share what felt like a disorientating thought.

“Cynthia, of all the members of our family, you’re the together one, the capable one and the successful one,” she said.

Though flattered, my thinking was, “How can that be? I’m the daughter with all the problems. The pain, the wheelchair, the one left childless without her show-biz career.”

I’m guessing now that my mother was intuitively letting me in on a secret -- a generations-long family secret. By telling me I had the right stuff, Mom was revealing that I’d broken the trauma cycle. She potently advised that I never let my family members hold me back, to “never not succeed because of them.”

That day I realized I’d done something exceptional, but I didn’t fully understand what it was. You’d think 38 years of chronic pain would have opened my eyes, but it took a cancer crisis for me to deeply examine what my mother was shedding light on.

I come from a profoundly dysfunctional family (domestic violence, divorce, mental illness, suicide, alcoholism, etc.), one so traumatizing my doctor believes that the toll of trying to fix my family, along with the inflammation of CRPS, was what gave me cancer. To have a chance at survival, I had to walk away from the toxic members of my family, which was the hardest and best decision of my life.

Unfortunately though, walking away might not be enough. Now that I’m in remission, I’m concerned that my inability to unlock from my frequent harmful thoughts about the trauma of past assaults will bring on a swift and more aggressive cancer recurrence.

Trauma Release

Enter EMDR (Eye Movement Desensitization & Repossessing). For the uninitiated, EMDR is a psychotherapy treatment designed to alleviate the distress associated with traumatic memories. For years studies have shown that people with serious adult-onset illnesses – including high-impact pain and cancer – experienced many adverse childhood events (ACE’s), as I did.

I’ve long considered doing EMDR for trauma release, but feared stirring up the debilitating depression that my family often sparks. I won’t lie to you. My EMDR plunge has been god-awful, as it’s brought on a ton of expected grieving and even rage. That being said, I’m sticking with it - and astonished by EMDR’s effectiveness and the insight it evokes.

My phenomenal practitioner, Kathy, has pointed out two major, life changing themes. The first, that family trauma is handed down over many generations, adversely changing our gene expression through what’s termed epigenetics. Sadly, I was born into the thick of this ever-rolling harm.

When I was seven, my dad jumped off a bridge due to severe mental illness. Much dysfunction led to his suicide, but this was the tipping point that my family of origin never recovered from.

After sharing what limited knowledge I had of my dad’s past, Kathy quickly assessed that, like me, he had a traumatic childhood. I was stunned to learn that his parent’s alcoholism, affairs and abandonments, along with all of the denial and covering-up, deeply wounded him. That insight gifted me great empathy for the person who shattered my world.

Mom’s side of the family was equally trauma-inducing. After her parent’s ugly divorce and Grandma having my loving grandfather committed to an institution, she had my mother kidnapped. Legend has it that this broke my aunt Grace’s heart, as her agonizing death from leukemia at age 20 soon followed.

To this day, even with advanced dementia, my mother describes her own grandmother as “a witch, the most evil person I ever met.” It goes on and on.

Healing My Inner Child

I finally understand that I have a family tree evergreen with trauma, the root of all my physical and psychological illness.

The second theme Kathy put forth is that to release my trauma we have to heal my “inner child.” I now understand that even as a fetus I took in the negative chemicals and vibe of my mother’s nightmarish situation – and it’s my inner child who’s carrying the greatest injury. The work is tricky because to reach her, we must maneuver around the many protective, life-preserving mechanisms she’s used for 60 years.

With Kathy’s guidance via Zoom, I’m slowly making friends with my inner child. While I want to protect her from the knowledge of a tragic future, ultimately I have to be vulnerable enough to let her spill the repressed memories of violence and dysfunction that host the lion’s share of our trauma.

My hope is that by healing my inner child I can end the cycle of excruciating harm I endure when I think about my family’s countless trespasses. If I can get to a strong landing point of understanding and release, my depression will turn to just sadness – and from there I can move on with better wellness.  

I want to be free.        

No matter the outcome, Mom was on to something. Thankfully, I’ve cracked the family code by asking why and doing the hard work. As Kathy reminds me, I choose “to think, not drink” - and because I don’t maintain the dysfunctional status quo, I’ve “jumped out of a sinking ship.”

All this time I thought my life had been upended by pain, but I now realize it was family trauma that caused every ounce of my misfortunate.    

This insight lovingly brings me to my aunt Grace who, by breaking the family trauma cycle, saved my mother. While I never met her, I see Grace as an angel and forever feel a deep connection, so much so I named my work for her goodness.

We’ve always been compared, and I now see that our similarity extends beyond looks and personality. A quote I continue to hear in my research about generational trauma is “The first born daughter often carries what remains unresolved in the mother.”

Grace and I were the eldest daughters and gave everything to save our broken families, an impossible task.

GRACE HAeRING

It cost my dear aunt her life – and I think she’s proud watching me fight for mine.

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 15 co-morbidities for nearly four decades, and became a cancer survivor in 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

More Data Needed on Covid Vaccine Safety for High-Risk People

By Roger Chriss, PNN Columnist

The Covid-19 vaccine rollout in the U.S. hasn’t been so smooth or fast. Fortunately, however, the vaccines are proving to be generally very safe. But there have been some serious allergic reactions associated with the vaccines. And in a few tragic cases, there have been deaths.

As a result, it is worth looking closely at what is now known about vaccine safety, in particular for high-risk people such as the elderly and those with compromised immune systems.

On January 3, Florida physician Gregory Michael died 18 days after receiving the first dose of Pfizer's vaccine. He was an otherwise healthy adult who developed acute thrombocytopenia, a severe shortage of platelets, soon after being vaccinated. Michael ultimately died of a brain hemorrhage after a two-week effort to raise his platelet count.

This is the only known case of a platelet crisis after vaccination, but it’s not yet clear if the two are connected. Work to understand what happened is ongoing.

“I don’t know what this is. We’ll keep our eyes open and see if it happens to anybody else,” vaccine expert Paul Offit, MD, told The New York Times.

The Platelet Disorder Support Association released a statement calling Michael’s death “tragic and concerning,” but said patients with immune thrombocytopenic purpura (ITP) “should not be hesitant to be vaccinated.”

“The relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain. To our knowledge, this is the first such event reported after over 5 million such vaccinations. Based on the available data, the benefit to risk ratio strongly favors vaccination of all adults, including those with ITP,” the statement said.

There have been a few other deaths worldwide. The Jerusalem Post reported in December on the death of an 88-year-old man who died just hours after being vaccinated, and a 75-year-old who died of a heart attack shortly after getting a shot. Both cases are seen as coincidental and no further deaths have been reported as Israel continues to vaccinate its population.

Norway, however, has seen 29 elderly people die after being vaccinated, all of them over the age of 75. The deaths prompted Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant,” the Norwegian Institute of Public Health said in a statement.

Information about vaccine safety for higher-risk populations is not easy to get at present. For instance, there is as yet no clinical data on what vaccine risks may exist for women who are pregnant or lactating. Without that data, STAT News says “it’s impossible for any organization or expert to say with absolute certainty that there are no risks.”

As of today, over 60 million doses of vaccine have been given worldwide and nearly 20 million in the U.S. Based on the small number of severe adverse events seen so far, this means that the vaccines are extremely safe for the vast majority of people.

Norway and Israel are reporting side effects and outcomes faster than most other nations. Consequently, the recent deaths may be nothing more than an artifact of good public health statistics offering a complete picture of all risks.

But precautions for people who are elderly, frail or otherwise high risk may turn out to be justified. As more data from vaccination efforts worldwide comes in, the risks will be better understood.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

Over-the-Counter Pain Meds and Gabapentin Recommended for Trauma Patients

By Pat Anson, PNN Editor

Over-the-counter pain medications and gabapentin are the best line of treatment for trauma patients suffering from acute short-term pain, according to new study at a Texas hospital that minimizes the use of opioids.

Researchers at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center in Houston assessed two different combinations of non-opioid pain relievers in over 1,500 patients being treated for acute trauma, such as bone fractures and head injuries.

The treatment protocol that was deemed superior included a combination of inexpensive over-the-counter drugs such as acetaminophen and naproxen, with the nerve medication gabapentin (Neurontin). Opioids such as tramadol and oxycodone were only prescribed for breakthrough pain.

"Narcotics are not the mainstay of therapy for acute pain," said lead author John Harvin, MD, a trauma surgeon at the hospital and an associate professor at The University of Texas Health Science Center at Houston. "The research shows us that seriously injured people with acute pain can effectively be treated with an opioid-minimizing strategy."

The study findings, published in the Journal of American College of Surgeons, showed that a first-line pain regimen that used acetaminophen, ketorolac, naproxen, gabapentin or lidocaine patches reduced the use of opioids without a significant difference in pain scores. Only 62 percent of the patients were discharged with an opioid prescription.

"We used a generic pain regimen that is affordable at discharge. The discharge medications acetaminophen and naproxen can be bought over the counter. The only drug that requires a prescription is gabapentin and an as-needed opioid, if prescribed," Harvin explained.

The use of gabapentin as a treatment for acute pain is controversial, because recent studies show it has no significant analgesic effect and is increasingly being abused. In 2019, the Food and Drug Administration warned that serious breathing problems can occur in patients who take gabapentin with opioids or other drugs that depress the central nervous system.

But the use of gabapentin and over-the-counter pain relievers is now the standard treatment protocol for trauma patients at Memorial Hermann-Texas Medical Center, and physicians there are working to adapt it for the treatment of acute burn pain.

"The best way to decrease someone's risk for long-term (opioid) use is to minimize their exposure during hospitalization and at discharge, and we now know there are excellent non-opioid medications available that effectively treat pain,” said Harvin. “We know that culture change will take time and effort, but we're excited to be learning how to best leverage opioid-minimizing drugs to improve care, and to offer a new model that can be adopted by any trauma center."

The risk of long-term opioid use after an emergency room visit is actually quite low. A 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, a Mayo Clinic researcher. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

Antidepressants Ineffective for Back Pain and Osteoarthritis

By Pat Anson, PNN Editor

Antidepressants like duloxetine (Cymbalta) are increasingly being prescribed to treat various types of pain, but a new study shows the medications are largely ineffective for people suffering from chronic back pain or osteoarthritis and may even cause harm.

Many clinical guidelines recommend using antidepressants as pain relievers – even when depression is not involved -- yet evidence supporting that use is uncertain. To address that knowledge gap, researchers at the University of Sydney reviewed data from 33 controlled trials involving more than 5,000 adults who took antidepressants for low back or neck pain, sciatica, or hip or knee osteoarthritis.

Their findings, published in The BMJ, show that for people with back pain the effects of antidepressants were too small to be worthwhile, but for those with osteoarthritis there may be a small beneficial effect.

“The use of antidepressants to treat people with chronic back pain and osteoarthritis is increasing worldwide, but prior to our work, it was not clear whether antidepressants relieved pain or were safe,” said lead author Dr. Giovanni Ferreira, PhD, a postdoctoral research fellow at the Institute for Musculoskeletal Health at the University of Sydney. 

“We conducted a review of all randomised clinical trials evaluating the efficacy of antidepressants for people with back pain or knee osteoarthritis and found that for back pain the antidepressants were either ineffective or provided a very small effect, which was unlikely to be perceived as worthwhile by most patients. For people with osteoarthritis, effects were still small, but could be potentially perceived as worthwhile by some patients” 

Ferreira and his colleagues reviewed six classes of antidepressants: serotonin-noradrenaline reuptake inhibitors (SNRIs); selective serotonin reuptake inhibitors (SSRIs); noradrenaline-dopamine reuptake inhibitors (NDRIs); tricyclic antidepressants; and tetracyclic antidepressants. 

Results showed that SNRIs such as duloxetine reduced back pain after three months, but the benefits were so small they were unlikely to be considered clinically important to most patients. SNRIs had a slightly stronger effect on sciatica and osteoarthritis pain. 

Tricyclic antidepressants were ineffective for back pain, but might reduce pain in people with sciatica, although the evidence for that was weak.  

Industry Funded Studies 

Importantly, about two-thirds of people taking SNRI antidepressants experienced an adverse event such as nausea, fatigue, mood swings and weight gain.

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm,” said Ferreira, adding that doctors need to be upfront with patients about possible side effects.

Researchers say the long-term effects of antidepressants prescribed for chronic pain are not well known and many of the studies that do exist were sponsored by industry, raising the risk of bias. 

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm.”

— Dr. Giovanni Ferreira

“Large, definitive trials free of industry ties are urgently needed to evaluate the efficacy of antidepressants,” Ferreira said. “There needs to be more transparency about how evidence coming from those trials is appraised by guideline panels. A good starting point would be to consider all industry-funded trials to be at high risk of bias, and downgrade the strength of recommendations where industry-sponsored trials represent an important part of the available evidence.”

The Food and Drug Administration recently approved duloxetine as a treatment for fibromyalgia in pediatric patients, largely on the basis of a small trial conducted by Eli Lilly, Cymbalta’s manufacturer. Children enrolled in the study did show a modest improvement in pain, but several of them had serious adverse events, including two attempted suicides, suicidal thoughts, an intentional drug overdose, depression and hallucinations.

In their published findings in the journal Pediatric Rheumatology, Eli Lilly researchers downplayed the adverse events associated with duloxetine, saying they were not drug related or “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

A common complaint of patients who take duloxetine is how quickly they become dependent and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms, including electric-like sensations called “brain zaps.”

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded nearly 35,000 cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 4,000 of those adverse events resulted in death.

Pilot Study Launched of Ketamine Tablet as Pain Reliever

By Pat Anson, PNN Editor

Ketamine has become a trendy alternative treatment for pain, depression, anxiety and post-traumatic stress syndrome (PTSD). But to get it, you’ll need to get a ketamine infusion, injection or nasal spray – usually under strict medical supervision.

But someday you may be able to take a ketamine tablet at home, just like you would most other medications. A pilot study is underway at a New York City hospital to see if an oral formulation of ketamine and aspirin could be a useful treatment for pain.

“For certain patients, ketamine could be a real game changer,” says Dr. Joseph Habboushe, an emergency room physician and founder of Vitalis Pharmaceuticals. “If you look at pain management and what we have available to send patients home with, it’s really limited. We have NSAIDs. We have opiates. We have other things that sedate. It’s a fairly limited in choice.”

Ketamine is not an opioid and does not suppress respiration, making it relatively safe to use. But in high doses, it puts patients into a dissociative, dream-like state -- making it inappropriate for outpatient use.

What Habboushe and his colleagues hope to demonstrate is that a low dose of ketamine, when combined with aspirin, can be an effective and non-addictive pain reliever that can be used safely at home.

Their observational study at Maimonides Medical Center will enroll 25 patients with acute musculoskeletal pain, who will receive 0.5 mg of oral ketamine administered simultaneously with 325mg of aspirin. Pain scores and adverse events will be recorded at various intervals for up to two hours.

The study is being led by Sergey Motov, MD, an emergency room physician who is passionate about finding alternatives to opioids.

VITALIS PHARAMCEUTICALS

"The need for safe and efficacious analgesics in the emergency department and on an outpatient basis is stronger than ever," Motov said in a statement. “Taking a novel approach to orally-administered ketamine has the potential to move physicians one step closer to successfully combatting the nation's ongoing opioid crisis.”

Vitalis has developed a proprietary formulation of aspirin -- called VTS-Aspirin -- that delivers faster and stronger pain relief than traditional aspirin. Preliminary research indicates that combining VTS-Aspirin with low-dose ketamine may boost its potency.

“This is a proof-of-concept study. If we can demonstrate that ketamine will work orally, then it can be used for acute pain, maybe later chronic pain, maybe depression and all the other indications,” Habboushe told PNN. “If we can achieve that, it will be a breakthrough that will absolutely drive a lot of value to patients by reducing opiate need and reducing their pain in a very significant way. And so, it’s worth studying.”

Vitalis is also studying the use of VTS-Aspirin with fumaric acid as a treatment for multiple sclerosis that has fewer side effects. Also undergoing research is a combination of VTS-Aspirin with niacin as a treatment for high cholesterol.

Medical Cannabis Needs Better Research

By Roger Chriss, PNN Columnist

Much of the uncertainty and reluctance about using medical cannabis stems from a lack of high-quality research. Instead of randomized controlled trials, surveys and data-mining are commonly seen, leaving clinicians and policymakers with little to work with.

That is the basis for the American Medical Association’s concerns about states legalizing medical cannabis.

“Scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use,” the AMA declared in a policy statement.

Good research would help reduce such concerns. Unfortunately, a lot of recent research involves poor methodology and problematic funding, weakening potentially useful results.

For example, a recent study published in the journal Cureus found that cannabis was a “useful adjunct and substitute for prescription opioids” for chronic pain patients and had the added benefit of improving their physical function and quality of life.

To conduct the study, researchers surveyed 550 patients being treated at three licensed medical cannabis clinics in the northeastern United States, using an anonymous online survey consisting of 11 questions about medication use, pain levels and side effects.

This is very problematic. A convenience sample is a simple method for quickly grabbing data. Its downsides are that it isn't random and is subject to a lot of selection bias. And anonymous surveys are unreliable. As a 2018 Australian study showed, claims of prescription opioid use by people using medical cannabis are often very inaccurate.

Similarly, an observational study at 21 medical clinics in Canada found that the “high rate of cannabis use for chronic pain and the subsequent reductions in opioid use suggest that cannabis may play a harm reduction role in the opioid overdose crisis.”

But the study was sponsored by Tilray, a Canadian cannabis firm that has provided cannabis for clinical trials and is involved in the adult recreational-use market in Canada. Drug studies sponsored by industry need to be viewed with caution, since such studies are known to produce results favorable to the sponsoring organization.

In general, studies that collect data through convenience samples or anonymously via online surveys or apps are not reliable. And studies funded by industry may be biased.

What Happened to Sue Sisley’s Study?

Good studies do get done. However, their results are not always published.

In 2019 Sue Sisley, a psychiatrist at the Scottsdale Research Institute in Phoenix, finished a study on cannabis for post-traumatic stress disorder (PTSD) that took ten years to complete, promising that “the full results of the study, including all the data, will be publicly released."

But Sisley’s research still hasn’t been published. Last year she admitted the study findings may have been compromised by the poor quality of cannabis that the DEA allows for research.

“Most scientists end up with this mishmash of different strains (including stem sticks, leaves, etc.) — all of it seems to get thrown into a grinder in an overzealous effort to standardize the study drug batches for clinical trials," Sisley said.

Research results need to be published even if they are not positive. There is a tendency to promote positive results and hide negative findings. Publication takes a lot of time and effort, and negative results may impede the flow of research dollars.

But if the benefits and risks of medical cannabis are to be better understood, we need all the results. And researchers should get full credit for their work, even if the results aren’t what advocates or enthusiasts were hoping for.

Medical cannabis needs more high-quality research. Surveys of people recruited from a medical cannabis dispensary cannot be generalized to the population at large, and studies sponsored by industry must be treated with caution. Improving medical cannabis research will go a long way toward helping people use medical cannabis safely and effectively.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

Finding Strength in Little Things

By Mia Maysack, PNN Columnist

It’s a New Year, but that doesn’t necessarily mean all that much to those of us who continuously hurt. We are seemingly living in a perpetual state of Bill Murray-like Groundhog Days -- experiencing the same painful occurrences over and over and over.  

Yet there are limitations to becoming accustomed to the inevitable, because the ailments themselves are ever changing and evolving, requiring us to adapt to them.  

As a result of COVID-19, millions of people who couldn't begin to imagine what it's like to be housebound all day, missing out on important gatherings and enjoyable outings, know what it’s like to have a disease threatening their physical and emotional health.  

It's a unique opportunity to bridge a gap with people who were once unable to relate to me. They learned how I've existed for years: shut-in, limited, alone, and cautious of potential harm or consequences.  

Despite the obstacles, I chose to fixate on gifts of other sorts, the “little” things such as life itself. There is always an amount of suffering that plays a role in my everyday existence, but isn’t that just how life goes in general?  

Some moments are better than others, which I am extraordinarily grateful for. Especially after having lived a majority of my years when there was no improvement, almost leading to complete hopelessness. 

If I did not greet another sunrise, it's true there would be no more discomfort. But it would also mean no more beauty either. Rain, for example, is a necessary requirement for anything to prosper. And the individual storms we all experience in unique ways are intended for personal growth. They heighten our empathy, compassion, understanding and acceptance.

Through the trauma of persistent agony, I've learned how to meet others by both respecting and honoring their journeys, despite the differences between us. Incurable and untreatable circumstances can produce a special humbleness that permits clarity in seeing each other as equals, regardless of the circumstances.  

Being faced with so much difficulty in activities of daily living is daunting to say the least. There were times when I have been swept up and consumed by all that I cannot do, hindering the possibility of investing energy and thought into what I can do. Or how to face challenges in more creative ways, as opposed to merely accepting “no” for an answer.  

Honoring my conditions has helped me to surpass them in some regards. This has assisted in strengthening an ability to fully appreciate what I'm able to accomplish, even if it's minor. Because everything we make it through is a victory in its own right.  

When reflecting upon all we've endured, there should be a tremendous amount of pride in our refusal to give up -- despite how tempting it has been and may still be at times. When we're in need of a reminder, bear witness to how far we've come and the power we have to make it through anything. Though be it far from easy, the quality of our lives is the most worthwhile investment.

Had we not been dealt the hand we received, we would not be who we are. Each of us harbors so much value to offer one another and the world through our experiences. There is always something to be learned and taught.

The treachery of pain continues to test me, but knowing I am not alone provides a sense of relief -- not that I'd wish this on anybody. I've gained a lot that I can now turn around and offer back to the world through legislative action, community involvement, public service and educational efforts. None of which would be possible without each and every twist and turn on this road we call life. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

Breakthrough Medical Devices to Receive Medicare Coverage

By Pat Anson, PNN Editor

Medical device manufacturers are cheering a decision by the Centers for Medicare & Medicaid Services (CMS) to have Medicare begin covering hundreds of “Breakthrough Devices” certified by the Food and Drug Administration.

The FDA’s Breakthrough Device Program was launched in 2018 to speed up the development of innovative technology for the treatment and diagnosis of life-threatening or debilitating medical conditions such as chronic pain. But FDA approval was then followed by a lengthy and costly review process for Medicare coverage, which delayed patient access to the devices.

The Medicare Coverage of Innovative Technology (MCIT) rule change allows Medicare to begin covering breakthrough devices simultaneous to FDA approval, making them immediately available to over 60 million Medicare beneficiaries. The rule change goes into effect March 15.

“Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” CMS Administrator Seema Verma said in a statement. “CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”

The rule change benefits companies like San Francisco-based Bone Health Technologies, which announced last month that its OsteoBoost Vibration Belt had received breakthrough device approval as a treatment for osteopenia, a precursor to osteoporosis.

“We are thrilled by this announcement as it will help us get our potentially life-changing device, affordably into the hands of patients who need it much more quickly,” said Laura Yecies, CEO of Bone Health Technologies. “There is a lack of safe, effective treatments for osteopenia, a condition that effects over 40 million Americans. It is exciting that CMS is supporting the efforts of companies working to solve these important unmet needs."

Another company likely to benefit is AppliedVR, which announced in October that its virtual reality headset had received breakthrough device approval as a treatment for fibromyalgia and chronic intractable low back pain.

“This new rule change means that Medicare recipients in need of pain relief will have access to our novel chronic pain therapy,” said Josh Sackman, co-founder and president of AppliedVR, who believes Medicare reimbursements will help speed up coverage of breakthrough devices by private insurers.  

“The MCIT rule change doesn’t directly impact coverage from commercial payers. They will continue to have their own standards for evidence and require new products to follow the existing evaluation process. However, the mandatory Medicare coverage will accelerate products getting into the market, where real world evidence will be collected on the value of those Breakthrough Devices,” Sackman explained in an email to PNN. 

“This data is extremely valuable for commercial payers to assess coverage. This should have a halo effect with payers that see the benefits of a breakthrough device in their Medicare book of business and may help them choose to expand coverage to their other lines of business, including commercial plans.”

Medicare coverage of a breakthrough device will initially be limited to four years. After the coverage period is over, CMS will reevaluate the devices based on clinical evidence of their effectiveness. Importantly, the four-year window also creates a revenue stream for manufacturers to continue improving their devices or invent new ones.

California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

Insurance Claims Show Lyme Disease More Widespread

By Pat Anson, PNN Editor

A new analysis of insurance claims by the Centers for Disease Control and Prevention suggests that Lyme disease may be far more widespread in the United States than current estimates.

CDC researchers looked at data from MarketScan, a large commercial insurance claims database, and found that Lyme disease diagnoses from 2010 to 2018 were six to eight times higher than the number of cases reported to a federal disease surveillance program.

Lyme disease is a bacterial illness spread by ticks. When left untreated, it can lead to chronic disorders such as fatigue, muscle and joint pain, cognitive issues and other symptoms that are often diagnosed as fibromyalgia, neuropathy and autoimmune disorders.

Most reported cases of Lyme disease occur in 14 states in the Northeast, mid-Atlantic and upper Midwest, especially during the summer months when more people spend time outdoors. Recent studies show Lyme is spreading to neighboring states and is no longer just a seasonal disease, possibly do to the effects of climate change.

The CDC analysis of insurance claims filed by nearly 23 million Americans identified over 140,000 people who were diagnosed with Lyme disease during the study period. That works out to a nationwide rate of 73 cases for every 100,000 people, a rate substantially higher than the 9 cases per 100,000 reported by the surveillance program.

“Age and sex distributions among Lyme disease diagnoses in MarketScan were similar to those of cases reported through surveillance, but proportionally more diagnoses occurred outside of peak summer months, among female enrollees, and outside high-incidence states,” wrote lead author Amy Schwartz, an epidemiologist in the CDC’s Bacterial Diseases Branch.

Schwartz and her colleagues say the larger number of Lyme cases reported by MarketScan may be the result of misdiagnoses, but the volume of claims warrant further investigation.

“Although Lyme disease diagnoses identified from claims data are not supported by the robust evidence of infection required for surveillance reporting, they are a consistent indicator of trends in the healthcare system. In addition, the sheer volume of data available through MarketScan provides potential for new insights into the epidemiology of Lyme disease diagnoses in the United States,” they said.

The CDC findings are similar to a 2017 analysis of insurance claims by the non-profit FAIR Health, which found an unexpected surge in Lyme disease cases during the winter and early spring.

Early symptoms of Lyme disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye. Lyme disease is usually treated with antibiotics.

About 30,000 cases of Lyme disease are reported annually by state and local health departments to the surveillance program. The CDC acknowledges, however, that the actual number of cases is probably much higher and that about 300,000 Americans may become infected every year.

Skin Patch Reduces Pain Without Use of Drugs

By Pat Anson, PNN Editor

A drug-free skin patch that uses nanotechnology to help dial down pain levels provided significant relief to people living with arthritis, neuropathy and musculoskeletal pain, according to the results of a small study.

The Kailo pain patch contains billions of tiny nanoparticles made with copper, silver and silicon that help transmit electromagnetic signals from the nervous system. In theory, the nanoparticles act as a “bridge” over inflamed nerve pathways and restore their ability to transmit pain signals properly.

The patch is made by Utah-based Pain Relief Technologies, which claims in marketing material that its patented technology provides “natural relief anywhere on your body, in seconds.”

In the study, 66 patients wore the Kailo patch while continuing to take oral analgesic medications such as opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

After 30 days, self-reported pain levels dropped significantly and 98 percent of patients said they reduced or stopped using oral medication. Their mood, sleep, walking ability, and other quality of life measures also improved.

The study findings, published in the journal Anesthesia and Pain Research, suggest that the analgesic effects of the Kailo patch are long lasting. About one in every four patients said their pain did not return after the patch was removed. Over half said it took at least a day for the pain to resume.

CLARITY SCIENCE IMAGE

“Modern science has allowed the incorporation of nanotechnology into topical patch systems, minimizing, and in the case of Kailo, eliminating the need for drugs/pharmacological agents. The interim results of this study are incredibly positive, and we look forward to providing the next phase of data that we have collected from patients with mild, moderate or severe pain,” lead investigator Jeffrey Gudin, MD, said in a statement.

Gudin was compensated by Clarity Science for conducting the study. You may recognize him from TV commercials for SalonPas, a rival pain relief patch.

An anesthesiologist by training, Gudin has become a prolific researcher, consultant and public speaker for dozens of companies involved in pain management, including Purdue Pharma, Salix, BioDelivery Sciences and Quest Diagnostics. He’s been paid over $1.5 million for his services since 2013, according to the OpenPayments database. In an email to PNN, Gudin said most of the money has been used for research and consulting on new analgesic therapies.

The Kailo patch is reusable and can be purchased without a prescription for $119. Reviews on Amazon for Kailo are mixed.

“Immediately upon placing it on my low back I could feel a warmth and my pain decreased rapidly. I was able to go to work the next day with relative comfort,” wrote one buyer who suffered pain from a hamstring injury.

“Did not reduce pain actually increased pain level,” said a disappointed user.

“Nothing else has worked for me but this significantly reduced my pain. It does not completely remove the pain, so don't expect that. But it reduced it enough that I can play with my kids, mow the lawn, work, essentially be a normal human being without medication,” said another user.

“I used it for a week, received no relief whatsoever,” wrote another buyer. “I am very dissatisfied and would like my money back.”

Topical Gel Shows Promise as Treatment for Neuropathic Pain

By Pat Anson, PNN Editor

An experimental gel developed to prevent skin damage caused by aging and ultraviolet light is showing promise as a treatment for chronic neuropathic pain, according to research underway in Australia.

The topical gel – known as RM191A – contains a copper-based compound that is absorbed by the skin and prevents the buildup of free radicals that cause skin damage associated with aging and skin cancer.

In a study recently published in the journal Redox Biology, RM191A was found to have potent antioxidant, anti-inflammatory and wound-healing properties in laboratory mice.

The gel is currently being evaluated in 24 patients at a Sydney hospital as a treatment for chronic nerve pain caused by surgery, chemotherapy, trauma and diabetes.  Results are expected later this month.

“Early sample uses of this topical formulation indicated it could be a significant in the management of certain types of chronic nerve pain,” says Llewellyn Casbolt, chief scientist and co-founder of Sydney-based RR MedSciences, which is developing the gel.

“In many ways, scientists see our discovery as a new class of anti-inflammatory that acts by the modulation of free radicals as well as reducing several inflammatory cytokines, providing a drug that can be therapeutically useful where the reduction of inflammation, as well as cellular and tissue healing - indeed pain relief - is also advantageous for a patient.”

The company plans to release an over-the-counter version of its gel in the next 12-18 months as a treatment for skin damage. It will take longer to get regulatory approval for the gel as a treatment for nerve pain and may require a prescription.

RR MedSciences (RRMS) plans to conduct further trials and is seeking additional partners and funding to accelerate the gel’s development.

“The management of pain, often related to conditions of inflammation or trauma that results in nerve or chronic pain is an area of great need.  Advancing the ability for people to modulate their pain, in a safe and effective manner that improves quality of life, is a core objective,” said Helena Libershal Casbolt, CEO and co-founder of RRMS.

A subsidiary of RRMS is currently selling a copper-based body cream called Blue Healer Care as a treatment for damaged skin and for relief from skin irritation and muscle soreness.

Mild Withdrawal Common Among Pain Patients Who Use Cannabis

By Pat Anson, PNN Editor

About 10 percent of patients who use medical cannabis to relieve chronic pain develop more severe withdrawal symptoms, according to a new study that found most patients have only mild symptoms and remain stable after long-term cannabis use.

Researchers at the University of Michigan Medical School and the VA Ann Arbor Healthcare System followed 527 Michigan residents with chronic pain for two years, asking whether they experienced any of 15 different withdrawal symptoms – such as craving, nausea, irritability and aggression - when they had gone a significant amount of time without using cannabis.

At the start of the study, most had only mild (41%) or moderate (34%) withdrawal symptoms, with 25% of the patients classified as having severe withdrawal.  Researchers say many patients were not even aware they experienced withdrawal, attributing symptoms such as fatigue and poor sleep to their underlying pain conditions, not to any dependence on cannabis.

"Some people report experiencing significant benefits from medical cannabis, but our findings suggest a real need to increase awareness about the signs of withdrawal symptoms developing to decrease the potential downsides of cannabis use, especially among those who experience severe or worsening symptoms over time," says lead author Lara Coughlin, PhD, an addiction psychologist at U-M Medical School.

After one year, about 13% of the patients experienced more withdrawal symptoms, with 8% reporting more severe symptoms after two years. People who were younger, smoked cannabis, used larger doses, and had poor mental health were more likely to have severe symptoms.

However, the vast majority of cannabis users did not experience more withdrawal symptoms, with those who reported mild symptoms likely to stay that way. About 20% of patients reported fewer symptoms after one year and 14% had fewer symptoms after two years. Older age and vaping were associated with lower odds of having severe symptoms.     

“The majority of participants remained in their initial withdrawal class throughout the 2-year study period, with the highest stability among those with mild withdrawal symptoms at baseline. Of those who transitioned to another symptom class, transitioning to milder symptoms was slightly more common than transitioning to more severe symptoms,” researchers reported in the journal Addiction.

“For the majority of patients, the current findings indicate that the severity of withdrawal symptoms are likely to remain stable over time.”

Poor sleep was the most common withdrawal symptom, followed by depressed mood, decreased appetite, craving, restlessness, anxiety and irritability. The study did not assess whether cannabis was effective for pain relief or what form of ingestion worked best.

Cannabis Not Perceived As Risky

Most Americans believe cannabis has less abuse potential than alcohol and many commonly prescribed anti-anxiety and pain medications, according to survey results recently published in the journal Addictive Behaviors.

Researchers at the University of Delaware and Michigan State University surveyed over 1,000 adults in 2019 about their views on cannabis products such as hemp, CBD, THC and marijuana. The vast majority felt cannabis products have a valid medical use and have less abuse potential than hydrocodone, oxycodone, Xanax and Valium.

source: addictive behaviors

“These results suggest that consumers perceive CBD as more like an over-the-counter pain reliever such as Tylenol or Advil and less like prescription opioids,” researchers found. “They perceive CBD and hemp as medicinal and as having little potential for abuse, making them an attractive replacement for addictive pain relievers.”

The researchers acknowledged that there is little clinical evidence to support these views, but blame the lack of studies on the federal government’s classification of marijuana as a Schedule I Controlled Substance, saying it has “severely limited research.”

A longtime critic of federal marijuana policy was not surprised by the survey findings.

“The overwhelmingly majority of Americans have long abandoned the federal government’s ‘Flat Earth’ position that marijuana is highly dangerous substance without any therapeutic efficacy,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“It is time for Congress to jettison this intellectually dishonest position as well and remove cannabis from the Controlled Substances Act in a manner similar to alcohol — thereby ending the existing state/federal conflict and permitting state governments, not the federal government, to be the primary arbiters of cannabis policy.”