Forced Opioid Tapering: ‘The Next Great Experiment’

By Pat Anson, PNN Editor

Last month the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication. The agency said it had received reports of “serious harm” to patients who’ve been suddenly cutoff, including withdrawal symptoms, uncontrolled pain, psychological distress and suicide.  

A new study published in the Journal of Substance Abuse Treatment shows just how common the practice is. And how millions of pain patients are being subjected to a public health experiment with hardly anyone keeping track of what happens to them.

“The United States went through a great ‘experiment’ of expanding treatment of pain with opioids which has proved to be disastrous for public health. We have entered the next great ‘experiment’ of discontinuing opioid medications among the millions of Americans who are currently taking them,” said lead author Tami Mark, PhD, senior director of behavioral health at RTI International, a non-profit research institute.

“Little is known about how many individuals are tapering off opioid medications, whether observed tapering follows any… guidelines, and the extent to which rapid tapering is associated with negative consequences.”

Mark and her colleagues looked at medical and pharmacy claims for nearly 500 Medicaid patients in Vermont who had high doses of opioid medication discontinued from 2013 to 2017.

All of the patients were prescribed a daily dose of at least 120 MME (morphine milligram equivalent) and over half had been on that high dose for over a year. 

Although most clinical guidelines recommend a “go slow” approach to opioid tapering – especially for patients on high doses – only 5 percent of the Vermont patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering.

The Centers for Disease Control and Prevention recommends that patients on opioids be tapered only 10% a week, with even slower tapers of 10% a month for long-term users. Had those guidelines been applied in Vermont, most tapers would have taken up to a year to complete.

Half of Tapered Patients Hospitalized

What happened to the patients who were cut off? Nearly half were hospitalized or had an emergency room visit for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure. For tapered patients, the risk of being hospitalized was reduced by 7% for each additional week of tapering.

Researchers don’t know how many of the discontinued patients committed suicide or how many were referred to addiction treatment. Notably, less than one percent received medication assistance treatment (MAT) such as Suboxone.

The study did not look at why patients were taken off opioids or who initiated the discontinuation. But researchers believe some of the rapid discontinuations “may be due to a breakdown in the clinical relationship between physicians and patients” – suggesting the patients were forcibly tapered or abandoned by their doctors.

In its warning to doctors, the FDA strongly recommends that patients not be forcibly tapered and that patients and doctors should jointly agree to a tapering plan.

“Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients,” the FDA said.

Forced Tapering Widespread

How many patients have been forcibly tapered or discontinued is unclear, but it probably runs in the millions. A recent report from IQVIA found that there were 75 million fewer opioid prescriptions filled last year compared to 2014, with the biggest decline in high dose prescriptions. 

In PNN’s recent survey of nearly 6,000 pain patients, over 80 percent said they had been taken off opioids or had their dose reduced since the CDC released its controversial opioid guideline in 2016. Many were turning to other substances – both legal and illegal – for pain relief. And nearly half said they had considered suicide because their pain is poorly treated.

“I have been forced to taper to 90 MME. I had been stable and functional for 10 years at 135 MME. Now I can no longer work, and can barely take care of my children. I am considering suicide because my pain is unbearable,” one patient told us.

“I have been forcibly tapered by more than half and my pain is not being relieved at this dose. I am now unable to work or care for my children,” another patient wrote. “I live in constant anxiety (which worsens my pain) that I will be abandoned, refused any pain management, or reduced to a dose so low that taking my own life is the only way to escape the pain.”

“My forced taper was a little over a year ago. Before that I lived a small but functional life on high dose opioids. I took the same dose, from the same doctor for over a decade. Then I was forced off of 75% of my dose,” said another patient. “Once we got down to my current dose the medication was no longer enough to control my pain. I now live a tiny, nonfunctional life. I spend all my time in bed watching TV. I never leave the house. Showers are my worst enemy. And I am lucky. I wasn’t abandoned by my doctor.”

A noted critic of opioid prescribing calls reports like these exaggerations. Andrew Kolodny, MD, the Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), told Stateline that the number of doctors who are inappropriately tapering patients is likely very small and should not be blamed on the CDC.

"We have a very real problem in this country. But the CDC guidelines didn't cause it," Kolodny said. "The problem is that millions of Americans have been put on round-the-clock opioids at very high doses and for reasons that doctors now realize were not appropriate.

"What the FDA needs to tell doctors is that because it is so excruciating to come off of opioids, they need to be very selective about who they put on them.”

In a series of Tweets two years ago, Kolodny said patients on high doses should be forcibly tapered “even if patient refuses” and challenged assertions that forced tapering was risky and widespread.

Now Kolodny says he sympathizes with patients but claims they are being manipulated.

“Their emotions are real. But they’re being effectively manipulated to controversialize the CDC guidelines,” he told Stateline.

Many of Kolodny’s colleagues disagree. Over 300 healthcare professionals warned in a joint letter last year that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.” 

Do You Really Need Spine Surgery?

By David Hanscom, MD, PNN Columnist

In today’s medical environment, big business is taking over in almost every realm. The focus is on productivity, instead of ensuring the highest quality of care. For spine surgeons like myself, the revenue generators are procedures and “interventions” – even though most of them have been shown to be ineffective.

New technology has made the situation worse instead of better. The interventions are larger, more expensive and much riskier. You, the patients, have become targets and opportunities.

The last five years of my practice became increasingly intolerable. I would see several patients a week who had surgery performed or recommended on spines that didn’t have a surgical problem. I hit a tipping point when I saw an athletic older gentleman who had his spine fused from his neck to his pelvis for muscular thoracic pain after lifting weights. He went from playing tennis and golf to being housebound, on high-dose opioids and had a psychotic break.

He was fused in a crooked position and could no longer see his feet.  He had to undergo a second 12-hour surgery just to stand him up straight again.

His case was a significant factor in my decision to retire from my practice as a complex spine surgeon in December of 2018 to pursue educating the public as to the nature and extent of the problem, as well as present viable solutions.

Fusions Have Low Success Rate

Spine surgery works wonderfully well when there is a distinct identifiable anatomical abnormality and pain is in the expected region of the body. However, surgery works poorly if the source of pain is unclear.

There is a widespread belief among patients and many physicians that when everything else has been tried and failed, then surgery is the next logical step. Nothing could be further from the truth.

Defining the correct anatomical problem to surgically treat is problematic. One of the most glaring examples of blindly proceeding with surgery in spite of the evidence is performing a fusion for low back pain (LBP).

It is well-documented that disc degeneration, bone spurs, arthritis, bulging discs, etc. are rarely the cause of LBP. Often, we really don’t know where the pain might be arising.

The success rate of fusions for LBP is less than 30%.  Most people expect a much better outcome and the resulting disappointment is problematic.

Another major problem is that when a surgical procedure is performed in a person with chronic pain in any part of the body, he or she may experience chronic pain at the new surgical site between 40 and 60% of the time. Five to ten percent of the time, the pain is permanent.

Many patients have told me undergoing spine surgery was one of the worst decisions of their life: “If I just knew how bad this could be, I never would have done it.”

Consider what happens when you go to the dentist with a painful cavity that may require a root canal, crown or extraction. There is a defined problem, and the pain will usually disappear once the problem is solved.

But what if you had gum disease or jaw pain, and a tooth doesn’t appear to be the source? Would you let your dentist randomly work on different teeth to see if it might help?

Making an accurate diagnosis of the problem is always the first step in solving it. 

Understanding the Whole Picture

Chronic pain is a complex problem that requires time and a multi-pronged approach to treatment. Current neuroscience research has unlocked the puzzle of chronic pain and it’s a solvable problem using the correct paradigm. But in the current medical climate, surgeons are being asked (and pushed) to move too quickly, and not factor in all of the variables that affect pain and surgical outcomes.

One 2014 research paper reported that only 10% of orthopedic spine surgeons and neurosurgeons are addressing and treating the well-documented variables in patients that predict poor outcomes. For example, one common problem for patients is lack of sleep. A large four-year study out of Israel demonstrated that insomnia induces low back pain. If a patient is sleep-deprived for just one night, his or her pain tolerance drops dramatically.

There are two sets of variables to consider when deciding whether to undergo spine surgery.

1) Your anatomy:  Has your doctor used an MRI or diagnostic test to identify the anatomical problem? If there isn’t a clearly identifiable source of pain, then surgery isn’t an option, regardless of how much pain you are experiencing.

2) Your nervous system and body chemistry:  Are you calm? Or are you stressed and hyper-vigilant? If your nervous system is on “high alert” for any reason, the outcomes of surgery are predictably poor, especially if you can’t identify the anatomical problem.  

If you are stressed, there are simple, consistently effective measures that can calm your nervous system and help you become pain free, often without surgery.

We already have the knowledge and technology to offer superb care and much of the data is being ignored. Whatever you decide to do or what resources you might use, don’t jump into spine surgery until you understand the whole picture. It may be the biggest decision of your life. 

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Chronic Pain Causes Brains to Age More Rapidly

By Pat Anson, PNN Editor

Poorly treated or untreated chronic pain can lead to a number of other health problems, from high blood pressure and insomnia to depression and anxiety.

Now there is evidence that chronic pain also causes brains to age more rapidly, raising the risk of developing Alzheimer’s disease and other neurological problems associated with aging.

“Our findings highlight the need to address chronic pain, not just in older individuals but in potentially everyone, as pain may have unintended consequences in the brain that we don’t yet fully understand,” said lead author Yenisel Cruz-Almeida, PhD, a researcher at the University of Florida Institute on Aging.

Over a three-year period, Cruz-Almeida and her colleagues used magnetic resonance imaging (MRI) to measure the volume of gray and white matter in the brains of 47 older adults, ages 60 to 83.  The volunteers were free of neurological disorders and in generally good health, although 33 of them had some type of chronic pain.

Volunteers who did not have chronic pain had brains that appeared four years younger than their actual age.

Chronic pain sufferers had brains that appeared an average of two years older. They were also more likely to have greater pain intensity, have a “less agreeable personality” and be less emotionally stable, according to researchers.

The University of Florida produced this video on the study, which was recently published online in the journal Pain.

“Not everybody ages the same way,” said Cruz-Almeida. “I don’t want people to think, ‘Oh, I have chronic pain. I’m doomed.’ This is not the case. That is not the message we want to get out. There is more nuance than that.”

Interestingly, the volunteers who reported getting pain treatment in the last three months had younger-appearing brains compared to those that did not, suggesting that pain relief slows brain aging. Pain sufferers who had a happier outlook on life and were generally more upbeat also had younger-appearing brains.

“The pain experience is not just in your brain,” said Cruz-Almeida. “There appear to be avenues or things that could be done to change brain age.

“Our findings also suggest that both pain treatments and psychological traits may significantly mitigate the effect of pain on the aging brain and could further decrease the risk of age-related deterioration and death.”

Cruz-Almeida is planning additional research with a larger sample of older adults that will look at ways to alleviate accelerated brain aging.

The Hidden Benefits of Glucosamine

By Pat Anson, PNN Editor

Do you take glucosamine supplements to reduce joint pain and stiffness? You’re not alone if you do. According to a 2007 survey, nearly 20 percent of U.S. adults take glucosamine to prevent or treat pain from osteoarthritis, back pain and other conditions.

The evidence to support the use of glucosamine for joint pain is thin, but a large new study in The BMJ suggests regular use of the supplement can reduce the risk of cardiovascular disease.

Researchers at Tulane University analyzed 7 years of extensive health data for almost half a million adults aged 40 to 69 enrolled in the UK Biobank study. Those who regularly took glucosamine were about 15% less likely to develop heart disease or have a stroke.

Glucosamine occurs naturally in the fluid around joints and plays an importantly role in building cartilage. Glucosamine is extracted from shellfish and is often combined in supplements with chondroitin, a similar substance that is also found in joints.

People who took glucosamine in the BMJ study were more likely to be women, older, more physically active, have healthier diets and take other supplements.

Over the course of seven years, 2.2% of those who did not use glucosamine had a heart attack or stroke, compared to 2.0% of people who did use glucosamine. People who used glucosamine were also less likely to die from a heart attack or stroke, 0.5% vs. 0.7% of those who didn’t use the supplement.

The difference doesn’t appear to be significant, but when adjusted for risk and other factors, it means that glucosamine users had a 22% lower risk of dying from a heart attack or stroke.

For smokers, the benefits of regular glucosamine use were even greater. They had 37% less risk of having coronary heart disease compared to smokers who didn’t use the supplements.

Researchers didn’t establish the reason why glucosamine lowers the risk of cardiovascular disease (CVD), but they believe the supplements help reduce inflammation – one of the main factors involved in the development of heart disease, as well as chronic pain.

“Several potential mechanisms could explain the observed protective relation between glucosamine use and CVD diseases. In the National Health and Nutrition Examination Survey (NHANES) study, regular use of glucosamine was associated with a statistically significant reduction in C reactive protein concentrations, which is a marker for systemic inflammation,” researchers reported. “Other mechanisms might also be involved, and future investigations are needed to explore the functional roles of glucosamine in cardiovascular health.”

The UK’s National Health Service (NHS) downplayed the study findings, pointing out the cardiovascular benefits of glucosamine are “quite small.”

“If you want to reduce your risk of having a heart attack or stroke, it would be much better to concentrate on living a healthy lifestyle, rather than paying for glucosamine supplements,” the NHS said.

Have We Reached the Stem Cell Tipping Point?

By A. Rahman Ford, PNN Columnist

One morning while watching TV, I was astonished by one of the commercials that ran.  It was an ad for stem cell therapy.  That was when it dawned on me – stem cells had finally hit the mainstream.  It was no longer a procedure of myth and mystery that people saw as strange or taboo.  It was now real, obtainable and, dare I say, normal. 

The public discourse over the legitimacy of stem cell therapy (SCT) has taken a clear turn in recent years, away from fearmongering and misrepresentation, and toward medical innovation and less restrictive federal regulation. 

Stem cell therapy may have officially reached its tipping point.

The term “tipping point” was popularized by Malcolm Gladwell.  He describes it as “that one dramatic moment in an epidemic when everything can change all at once.”  For Gladwell, certain large-scale social phenomena – which he terms “epidemics” or “contagions” – take hold through small, incremental changes that tend to happen in a hurry.  

Gladwell asserts that, like medical epidemics, “tipping point” social epidemics obey three laws:

1. Law of the Few: They are driven by a handful of people

2. Stickiness Factor: At a certain point a message “sticks” in the memory

3. Power of Context: Human beings are sensitive to their environment 

Three groups of people facilitate successful social epidemics:

1. Mavens, who possess the specific information or knowledge

2. Connectors, who bring people together and disseminate that information

3. Salesmen, who persuade others to believe the information. 

It’s ironic that Gladwell uses examples of medical epidemics to describe a theory that could be applied to a modality with the curative power of SCT. The increasing and diverse number of patient testimonials online shows how SCT has reached its tipping point.

Roar Africa CEO Deborah Calmeyer used her own stem cells to repair a bone chip on a toe she injured falling down a flight of stairs at a Manhattan restaurant.  After two years, her pain was gone and the cartilage completely healed. 

Grandmother Andrea Coleman of Charlotte, NC used her own stem cells to heal her arthritis pain, pain which she described as “10+.”  Less than two months after the therapy, her pain was at a “2 or a 3.”  And how did she find the clinic?  Her husband did a simple online search.

High school wrestlers like JD Peralta of small-town Clovis, California used SCT to heal a torn ACL and meniscus. 

South Florida mother Marty Kelly credits SCT with curing her non-verbal autistic son Kenneth.  At eight years old, Kenneth couldn’t talk or reread and was still in diapers. Now, after nine treatments, 17-year-old Kenneth is about to graduate high school.  How did Marty Kelley find out about SCT?  She “stumbled” across a little boy in Orlando who also benefitted from the therapy. 

Finally, Superman actor Dean Cain used SCT to heal chronic pain from a knee injury he suffered playing college football.  He even invited DailyMailTV cameras to record the procedure.  Cain also credits SCT with controlling his father’s Parkinson’s Disease. 

When Superman becomes an SCT connector and salesman, you know you’ve reached the tipping point.

Small Clinics and Large Hospitals Tip the Scales

More and more clinics are offering SCT.  This proliferation is occurring despite the restrictive FDA regulatory regime that dictates stem cells should be “minimally manipulated” and only for approved treatments. Clearly, the medical professionals are not overly concerned with FDA policing and investigation. This is similar to marijuana which, while still illegal under federal law, is legally sold in dispensaries in dozens of states without fear of a crackdown.  

This perception that the FDA has adopted a permissive, laissez-faire stance is telling and evidences another SCT tipping point.

Not only is the number of small clinics increasing, but the availability of SCT in large, mainstream hospitals is further evidence of a tipping point.  As Liz Szabo points out in Kaiser Health News, major hospitals like the Swedish Medical Center – Seattle’s largest non-profit health provider – have begun offering SCT with infomercial-like advertisements.  The Mayo Clinic, Cleveland Clinic and the University of Miami have also entered the field to provide options to patients who have exhausted mainstream remedies. 

“We have patients in our offices demanding these treatments,” said Dr. Shane Shapiro of the Mayo Clinic. “If they don’t get them from us, they will get them somewhere else.”

A serious argument can be made that the SCT tipping point has indeed been reached.  Gladwell’s theory fits the SCT movement well.  Although the SCT movement’s initial push was driven by the few, as Gladwell conceptualized, it is the stories of the many that drive it now. 

Context has also been important. The pain and suffering of countless Americans has provided the context that has forced more clinics and hospitals to provide SCT.  And progress has been quick. Just nine years ago I had to go all the way to China for my SCT.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Oregon Drops Opioid Tapering Plan

By Pat Anson, PNN Editor

An Oregon health panel has tabled a controversial plan that would have forced tens of thousands of Medicaid patients with neck and back pain to stop taking opioid medication. The Health Evidence Review Commission (HERC) voted unanimously to wait for additional studies to be completed later this year, which effectively delays any change in medical coverage under the Oregon Health Plan until 2022.

The forced tapering plan drew nationwide criticism from pain sufferers, patient advocates and pain management experts, who said it would “exacerbate suffering for thousands of patients.”

"Pain is complicated and different for everyone," said HERC chairman Kevin Olson, MD, in a statement. "We heard loud and clear that pain treatment and opioid tapering should be individualized based on the patient-clinician relationship. I am pleased that we were able to align the neck and back coverage with these principles."

If a patient with any chronic pain condition is not doing well with an opioid taper, HERC said the tapering should stop without consequence to the prescriber or patient.

But patient advocates say some doctors have already implemented HERC’s forced tapering proposal without waiting for it to be finalized.

“Many patients across Oregon have already suffered tapering from their opiate pain management or have been dropped by their physician as a result of this policy. Those patients who have already been affected deserve proper treatment for their medical conditions and must have their previous pain management regiments and care reinstated,” said Amanda Siebe, a pain patient and disabled activist who recently announced she was running for Congress in Oregon’s 1st congressional district.

“It's time HERC made up for the damage they've done to this community over the last 2 years, and give us the proper care and coverage we deserve to maintain functionality and quality of life. This fight won't be over for us until all patients are able to receive the pain management, care, and coverage they need and deserve.”

The HERC also voted unanimously to continue not covering treatment for five common chronic pain conditions, citing a lack of evidence on the effectiveness of any therapy, including opioids. The five conditions are chronic pain caused by trauma, post-surgical chronic pain, chronic pain syndrome, fibromyalgia and “other chronic pain.”

Patients advocates had supported a plan to cover those condition, not only with opioid therapy, but with alternative treatments such as physical therapy, acupuncture and yoga.

“The conditions being discussed are valid conditions, and I think they’re in need of medical treatment options. I think that opioids should be a part of those options,” Wendy Sinclair, a pain patient and co-founder of the Oregon Pain Action Group told the Bend Bulletin. “Doctors and patients need to work together and have those options available.”

HERC’s decision to reverse course on tapering was a significant and rare victory for the pain community, which rarely gets a set at the table or is listened to when political and regulatory decisions are made about opioid medication.

Last year over a hundred pain management experts signed a letter to HERC warning that its tapering plan would have been the most restrictive in the U.S. and was unsupported by treatment guidelines. That warning was recently echoed by the Food and Drug Administration, which said rapid tapering and forced discontinuation of opioids was causing “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

Magic Mushrooms, Psychedelics and Chronic Pain

By Roger Chriss, PNN Columnist

The recent news that Denver has decriminalized “magic” mushrooms is the latest sign of growing interest in the use of psychedelics. Whether it’s microdosing mushrooms to stimulate the mind or using them to treat depression and chronic pain, psychedelic drugs are having a moment.

Magic mushrooms are any of roughly 200 different types of fungi that produce psilocybin, a hallucinogenic substance. Other psychedelics include LSD, DMT, ayahuasca and ibogaine. For reasons of chemistry and cultural baggage, DMT is generally avoided, LSD is used with extra caution and psilocybin is getting the most attention in clinical studies.

Preliminary research has found positive outcomes for psychedelic therapy in smoking cessation,  anxiety, post-traumatic stress disorder and refractory depression. And there are promising findings on psychedelics for cluster headaches and phantom limb pain.

A 2015 review in the Journal of Psychoactive Drugs reported that for patients with cluster headaches, psilocybin and other hallucinogens “were comparable to or more efficacious than most conventional medications.”  

In a 2006 Neurology review, researchers interviewed 53 cluster headache patients who used LSD or psilocybin. Most reported success in stopping cluster attacks and extending periods of remission.

And a 2018 Neurocase report described positive results for one patient with intractable phantom pain who combined psilocybin with mirror visual-feedback.

Obviously, these studies are very preliminary. Patient self-reports on drug use outside of clinical settings have limited value as evidence of efficacy. And case reports are by definition too small-scale to generalize from.

Fortunately, more clinical trials are underway for psilocybin and LSD. Last year the FDA approved a “landmark” psilocybin trial for treatment-resistant depression. And the Multidisciplinary Association for Psychedelic Studies is also working to promote robust clinical research.

Of course, psychedelics are not without risks. As described in detail in the book DMT: The Spirit Molecule, patients need to be screened and monitored before, during and after psychedelic therapy.

Michael Pollan, author of “How to Change Your Mind”, told The New York Times that psilocybin has risks “both practical and psychological, and these can be serious.”

There are also risks of conflating the pop culture phenomenon of microdosing to clinical benefits obtained under medical supervision.

The “betterment of healthy people” through microdosing is enthusiastically endorsed in books like “A Really Good Day” by Ayelet Waldman. But a 2018 placebo-controlled study on LSD microdosing found no “robust changes” in perception, mental acitivty or concentration.

The microdosing trend could stymie serious research and bias public opinion about psychedelics — just as it did in the 1960’s.

The potential for psychedelic therapy in the management of chronic pain disorders is two-fold. First, psychedelics may represent a safe and effective way to manage otherwise intractable disorders like cluster headaches and phantom limb pain. Second, psychedelics may help address the depression, PTSD and anxiety that often contribute to or accompany such disorders.

It is to be hoped that more research on psychedelics comes quickly.

Roger Chriss lives with 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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Is Tramadol Just as Addictive as Other Opioids?

By Pat Anson, PNN Editor

Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.

Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.  

"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."

Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.

Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.

"We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved," said senior author Molly Jeffery, PhD, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."

Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.

"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.

Audit Details Misuse of Funds at U.S. Pain Foundation

By Pat Anson, PNN Editor

It’s been over a year since serious “financial irregularities” were uncovered at the U.S. Pain Foundation and former CEO Paul Gileno was forced to resign under pressure. But the Connecticut based non-profit is still dealing with legal and financial fallout from years of nepotism, self-dealing and lax oversight by its management and board of directors under Gileno’s leadership.

A newly released audit of U.S. Pain and its 2018 tax return indicate that Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018. The board did not discover the financial irregularities until April 2018, when it hired an auditor and attorney to investigate.

‘The findings were clear that the former president had engaged in unauthorized transactions involving the misuse of assets of the organization. The Board demanded and received the former CEO’s immediate resignation on May 29, 2018, and shortly thereafter reported the matter to federal authorities,” the audit states. “The criminal investigation is still ongoing into the former president’s activities.”

In addition to the federal investigation, PNN has learned that the Connecticut Attorney General’s office is planning to seek a court order to prohibit Gileno from ever handling charitable funds again.

U.S. Pain is providing few details on how Gileno was able to misappropriate over $2 million from the charity over a three year period. The misused funds were reported to the IRS as “excess benefit transactions,” a broad category that includes unauthorized compensation, reimbursement for Gileno’s personal expenses, and payments to Gileno’s family members for unspecified work.

In addition to the $32,537 that Gileno received in wages for roughly five months of work in 2018, he collected over $166,000 in excess benefits last year. The latter amount includes a $36,000 payment to an unidentified company owned by Gileno. It is not clear what the payment was for.

PAUL GILENO

Gileno’s wife, sister and step-daughter were also on the charity’s payroll, collecting nearly $71,000 in wages in 2018. It is not clear what work they did. Gileno’s sister also received an unspecified amount of severance pay and maternity leave, according to the tax return.

The auditor also reported that U.S. Pain has been unable to recover any money from a $100,000 investment in SMJ Homes, a real estate business owned by Gileno’s brothers. A promissory note from the company was due in February 2019, but has not be repaid.  

Poor Business Decisions

In addition to the questionable payments to Gileno and his family, the audit and tax return show that U.S. Pain entered into a series of poor business decisions.

In 2016, U.S. Pain launched an “unrelated bakery business” that Gileno, a former caterer, established to “further the general mission” of the charity. Nothing in U.S. Pain’s mission statement says anything about a bakery.

The bakery was unprofitable from the start, reporting a net loss of nearly $70,000 in 2017. The board voted to liquidate the business last year at a cost of over $72,000 and recently agreed to pay another $23,900 to settle lease obligations for the bakery. In all, over $165,000 in charitable funds were wasted on the failed enterprise.

After Gileno’s departure, the board agreed to forfeit a non-refundable deposit of $50,000 that Gileno authorized in a failed attempt to purchase PainPathways magazine.

The board also scrapped a $2.5 million prescription co-pay program with Insys Therapeutics, a controversial drug maker whose founder and four former executives were recently convicted of racketeering. U.S. Pain said it would no longer accept funding from Insys, but rather than return leftover funds the board has kept $200,000 from the company in an escrow account.

Dealing with all of these legal and financial issues has been costly. According to its tax return, U.S. Pain paid nearly $514,000 for legal services, accounting and penalties in 2018 — nearly a quarter of its revenue for the year.

Gileno: “I Never Misled Them”

How could the self-dealing and financial irregularities go undetected for so long? Interim CEO and board chair Nicole Hemmenway said in a statement last December that Gileno “repeatedly misled and concealed information from the Board of Directors and staff.”

But Gileno, who has admitted taking money from U.S. Pain for his own personal use, maintains that he kept the board informed. “I never misled them. They were part of U.S. Pain for over 10 years and I talked with them daily. Nicole and I were close like a brother and sister and I never hid one thing,” Gileno told PNN last year. 

Gileno did not respond to a request for comment for this story. Neither did Hemmenway. A spokesperson for U.S. Pain said in an email the tax return and audit “constitutes our public statements on these matters.”

The charity’s 2018 tax return was filed on time, but its 2016 and 2017 returns were delinquent and filed late in 2018. They indicate there was no real oversight of Gileno by the board until last year.

“The former President/CEO controlled the board process. The records maintained under his leadership list the officers and directors… but contain no evidence that election of officers and directors occurred,” the tax returns said.

The audit indicates that U.S Pain “rents its main office from the father in law of an employee” who is not identified. Public records for the city of Middletown, CT indicate the building is owned by Ottavio Monarca, who is the father-in-law of Lori Monarca, U.S. Pain’s Executive Office Manager. Rent of $25,000 was paid for the office in 2018 and the lease continues until 2020.

Hemmenway was paid a salary of $71,750 in 2018. The other two board members, Wendy Foster and Ellen Lenox Smith, a former PNN columnist, did not receive any compensation. Smith’s daughter-in-law, Shaina Smith, was paid a salary of $76,700 in 2018 as Director of State Advocacy for U.S. Pain.

Despite all of these expenses and business losses, U.S. Pain appears to be in fairly good financial shape compared to other charities. It received over $1.8 million in donations and grants in 2018, and ended the year with over $454,000 in cash — an enviable position for most non-profits, which often struggle to raise money.

Major corporate donors to U.S. Pain include Abbvie, Amgen, Lilly, Sanofi, Novartis, Teva, Abbott, Pfizer and other pharmaceutical companies.   

Sen. Ron Wyden (D-OR), the ranking member of the U.S. Senate Finance Committee, sent a letter last December to Hemmenway asking a series of detailed questions about the charity’s relationship with Insys  and other drug makers. According to the senator’s office, Wyden has still not received a full response.  

“A substantial amount of information that Senator Wyden requested from the U.S. Pain Foundation remains outstanding. Staff continues to communicate with the foundation in order to fully understand the financial relationship and contacts it has had with pharmaceutical manufacturers, including Insys, and its compliance with applicable federal laws,” a Wyden spokesman said in a statement to PNN.

Kratom Gave Me Hope

By Dijon Evans, Guest Columnist

I have taken kratom for 2 years now. I was cut off of my pain meds, after 40 years of proper and adhered to treatment.

There was no taper. No discussion. No warning. My pain management doctors just stopped treating all chronic pain patients and, shortly after, all of their terminal cancer patients.

I have full body Complex Regional Pain Syndrome (CRPS), osteomyelitis, osteoporosis, neuropathy, sepsis, and two pulmonary embolisms.  I’ve had 3 amputations and have an artificial hip. My other hip needs replacement, as does my only knee. My spinal vertebrae are either broken, fractured or collapsed.

I've been having my jawbones ground on, drilled into and screwed together, all with no pain medication because of the panic caused by the CDC guideline, DEA enforcement and imprisonment of doctors.

Two years ago, I was leaving my home (after being bedridden for over 10 years) and asked for help getting into my wheelchair. I was on my way out the door to end my own life.

After being abandoned by the medical profession and my government, I lost all hope. I had no quality of life. And I sure as hell wasn't going to be tortured.

That's when I took my first bit of kratom. When my care provider, my boyfriend, showed up later that day, we both cried. He knelt beside me as I was sitting on the couch. Not in bed. Not begging for mercy. But sitting on the couch, smiling.

Yes, I am still terminal. Yes, I have bad days and flare ups. My doctors know I take kratom, follow me and cannot believe that when they see me, for the most part, I am smiling. I push my own wheelchair into my appointments.

DIJON EVANS

I have blood work each month. No, I am not cured. But I now have hope.

My daughter and grandkids are happy to see me, not dreading it. I'm not in the hospital or ER as much. I have a little bit of quality of life -- while I can.

Is this really too much to ask?

I've done my research. I am educated. I'm an intelligent person. A grandma, a daughter, sister, niece, cousin, a mother, a significant person in several lives. I am important. I do matter.

I don't use much kratom, but if I was asked to change the amount and manner and participate in a clinical trial, I would gladly do so in order for the millions who may benefit and have benefited from it.

Dijon Evans lives in California.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Mindfulness Is More Than Yoga

Barby Ingle, PNN Columnist

For years I’ve used mindfulness meditation techniques to help with my chronic pain. So imagine my surprise last week as I was watching the Pain Management Best Practices Inter-Agency Task Force meeting and a practitioner on the panel said yoga and mindfulness are essentially the same thing.

I’ve never done yoga as part of my mindfulness meditation. But it made me start to wonder. Have I been doing mindfulness wrong for years?

A quick Google search showed me there are more than 25 mindfulness activities. Yoga was one of the items on the list, but not everyone doing yoga is doing it for mindfulness. Most use it for physical exercise.

Another practitioner on the task force said that mindfulness is not a treatment by itself and that it is typically done in conjunction with other modalities. I totally agree. There are many group and individual activities that use mindfulness to reduce stress, anxiety, depression and pain.

Mindfulness is just one form of self-care that I use do to help manage the symptoms of living with chronic conditions. By itself, mindfulness is not enough to sustain me, but in conjunction with other treatments I find it helpful.  

I personally like individual mindfulness activities. Some of the activities are really short and some take up to an hour. Depending on what I need, I choose one that best suites me in the moment. Some of the activities I use for improving my life include virtual reality, self-compassion, reviewing my "I Am" list, meditation, 5 senses exercise, breathing exercises, music therapy and aroma therapy.

If you have trouble practicing mindfulness alone, one of the group activities is known as the FAKE plan, which involves about 8 members meeting for 2 hours every week for 12 weeks. The first portion of each session is devoted to a short mindfulness exercise and discussion, and each week is dedicated to a specific type of mindfulness exercise.

This is great for patients with social anxiety disorder but can also be helpful for others who want to work on their social skills through group mindfulness activities.  

Another mindfulness exercise that I found in my Google search (but have not yet tried) involves staring at a leaf for 5 minutes. A leaf is like a fingerprint or snowflake -- no two are the same. You can focus on the leaf’s colors, shape, texture and patterns. This type of activity brings you into the present and helps align your thoughts.

When I am not able to perform the physical or cognitive tasks I want to because of physical pain, I can get situational depression. For me, this is the best time to use my mindfulness activities. One study identified three ways mindfulness helps when you are depressed:

1.  Mindfulness helps people learn to be present in the moment, take stock of their thoughts and feelings, and choose an appropriate response rather than get caught up in negative emotions.

2.  Mindfulness teaches people that it’s okay to say “no” to others, which helps them balance their own lives and enhance self-confidence.

3.  Mindfulness allows people to be present with others, making them more attentive to their relationships, aware of their communication problems and more effective in relating to others.

These are important tools that can help chronic pain patients better manage their lives. Mindfulness activities help clear your mind of worry about the past or future and allow you to focus on the present.

Whether you are using mindfulness for anger, depression, chronic pain, anxiety or just for overall mental health -- it is important to keep an open mind. I know that is easier said than done when you are in severe pain. But the more you practice mindfulness the easier and more useful it becomes.

Can mindfulness cure you? No. Its purpose is to relax and help put life into perspective. If you are angry and distressed, that’s okay. I go there too sometimes. I use mindfulness to live in the moment and manage my emotions so that I am better able to manage my physical pain.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Still No Relief in Sight for Canadian Pain Patients

By Marvin Ross, Guest Columnist

Last month the U.S. Centers for Disease Control and Prevention said the agency’s 2016 opioid guideline does not endorse rapid tapering or discontinuation of opioid therapy. The CDC was responding to mounting criticism that its controversial guideline was causing harm to patients, including uncontrolled pain, depression and suicide.

As a Canadian, I am envious and embarrassed, for it is not over for pain patients in Canada. Americans have had active advocates in the American Medical Association and hundreds of doctors signing a public letter of protest, which resulted in the CDC and Food and Drug Administration finally admitting that forcing people to go off opiates is not good practice.

Canadian docs have said little about this, so I decided to ask the main authors of Canada’s opioid guideline, which is pretty much a copy of the CDC’s. They had written in response to me last year in the Canadian Medical Association Journal that they had “concerns” about inappropriate tapering and would “monitor the emerging literature.” Only one replied to me this time, saying that they speak out whenever they can, but no one will listen to them.

One anonymous doctor going by the name of “doc2help” objected to a piece I did in Medium suggesting that Canadian doctors have lost their moral compass. He thinks I am ill informed and doing damage.

I also let the office of the Canadian Minister of Health know what the CDC and FDA have done, as Health Canada has the same regulatory powers for drug approvals as the FDA. The answer was that they are having internal discussions.

Meetings and discussions make the bureaucracy go round-and-round. The Minister of Health did recently announce the formation of a chronic pain task force, but it has a three year time frame for more meetings.

It is so much easier to blame patients and opioid prescribing, as Canadian authorities continue to do, even when most drug overdoses are the result of illicit fentanyl, not prescription opioids.

In Hamilton, Ontario, a medium sized city southwest of Toronto, opioid deaths are going up, while prescriptions are going down. Much of the illicit drugs in that city are due to pharmacy diversion, according to an excellent article in the Hamilton Spectator that revealed vast amounts of prescription drugs are making it onto our streets.

So far, 15 pharmacists have been caught peddling opioids illegally and Health Canada has found that over 1,400 Ontario pharmacies have reported missing drugs that they cannot account for. 

Dr. Anne Holbrook, director of clinical pharmacology at McMaster University, suggested it is patients who are selling their prescriptions on the street, but provided no studies to back up that claim when she spoke to the Spectator reporter. I have asked her directly and via the media relations department at McMaster University, but did not get a reply.  

Blaming patients is easy when you do not want to confront the fact that most street drugs are coming into the country illegally or being diverted by pharmacies.

A Toronto Star investigation found one Ottawa pharmacy that was responsible for putting at least 5,000 fentanyl patches on the street. The investigation found that between 2013 and 2017, nearly 3.5 million doses of prescription drugs disappeared from Ontario pharmacies. Over 200 Ontario pharmacists were disciplined by their professional body for diverting “massive amounts of deadly opioids.”

Our governments are ignoring all of this and blaming the poor chronic pain patients. Those of us in Canada will have to wait while the bureaucrats hold meetings and write papers before anything will be done.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Record Decline in Opioid Prescriptions

By Pat Anson, PNN Editor

Often lost in the debate over opioid medication is that prescriptions for the drugs have been falling for years — a trend that appears to be accelerating. The volume of prescription opioids dispensed in the U.S. last year fell 17 percent, the largest annual decline ever recorded, according to a new study by the health analytics firm IQVIA. Opioid prescriptions have dropped 43% since their peak in 2011.

“Decreases in prescription opioid volume have been driven by changes in clinical use, regulatory and reimbursement policies and legislation, all of which have increasingly restricted prescription opioid use since 2012,” the report found.

The biggest drop was in high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more, which account for 43% of the decline. Low dose prescriptions of 20 MME or less have remained relatively stable, falling just 4 percent.

While opioid prescriptions have fallen significantly, addiction and overdose rates continue to soar, fueled in large part by illicit fentanyl, heroin and other black market opioids.

“We saw many more people receiving medication-assisted treatment (MAT) for opioid addiction. Our research shows new therapy starts for MATs increased to 1.2 million people in 2018, nearly a 300 percent increase compared with those seeking addiction help in 2014,” said Murray Aitken, IQVIA senior vice president.

“This is an important indicator of the effects of increased funding and support for treatment programs to address addiction.”

A recent report by the Bipartisan Policy Center estimates the federal government spent nearly $11 billion since 2017 subsidizing the addiction treatment industry, much of it spent on MAT drugs such as buprenorphine (Suboxone).

Drug maker Indivior recently reported the buprenorphine market had double digit growth in the first quarter of 2019, and that “growth continues to be driven primarily by Government channels.”

Hydrocodone Prescriptions Drop

For the 7th consecutive year, prescriptions fell for hydrocodone-acetaminophen combinations such as Vicodin, Lortab and Norco. Once the #1 most widely dispensed drug in the nation, hydrocodone now ranks fifth, behind drugs used to treat thyroid deficiency, high blood pressure and high cholesterol.

Only 68 million prescriptions for hydrocodone were dispensed last year, half the number that were filled in 2011.

U.S. HYDROCODONE PRESCRIPTIONS (MILLIONS)

Source: IQVIA

Due to fears about addiction and overdose, hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, requiring new prescriptions for every refill.

“My hydrocodone has been cut in half and my pain is out of control. I feel like a criminal, like I am committing a crime each time I pick up my prescription. I now have to visit my doctor once a month to receive my script,” one patient told us.

“I was prescribed hydrocodone over the last couple of decades for severe chronic pain with very positive effects. Now I am unable to carry out a lifestyle for a man my age, I'm basically done/finished.  My way of life is over,” a disabled veteran wrote.

“Stop denying the patients that have real pain. I don’t use it to get high. Hydrocodone is the only thing that has helped my back pain. I’ve tried a lot of things but nothing helps. It frees me of enough of the pain that I can function like a normal person,” another patient said.

The shift away from hydrocodone and other opioids has benefited pharmaceutical companies that make non-opioid medications such as Neurontin (gabapentin) and Lyrica (pregabalin).  Prescriptions for gabapentin reached 67 million last year – nearly the same as hydrocodone.

These trends have yet to show much benefit for pain patients, who increasingly report their pain is poorly treated. In a recent PNN survey of nearly 6,000 patients, over 85% said their pain and quality of life are worse since the release of the CDC opioid prescribing guideline. One in five say they are hoarding opioid medication because they fear losing access to it in the future.

Doctors Prosecuted for Opioid Prescribing Should Fight Back

(Editor’s note: In 2016, Dr. Mark Ibsen’s medical license was suspended by the Montana Board of Medical Examiners for his opioid prescribing practices. Two years later, the suspension was overturned by a judge who ruled that the board made numerous errors and deprived Ibsen of his legal right to due process.)

By Mark Ibsen, MD, Guest Columnist

The headlines are pretty typical: “60 Doctors Charged in Federal Opioid Sting.” The story that follows will include multiple damning allegations and innuendos, including a claim by prosecutors that they are “targeting the worst of the worst doctors.”

Sometimes there is a trial, but often the doctors plead guilty to lesser charges and give up their license rather than mount a lengthy and costly legal defense.

Why are doctors losing every case to their medical boards and DEA? Are there that many criminal doctors? If so, what happened to our profession?

I see a pattern emerging: A doctor sees patients and treats pain in the course of their practice. As other doctors give up prescribing opiates for fear of going to prison or losing their license, the ones left end up seeing more and more patients.

They soon become the leading prescribers of opioids in their state and become suspect just based on the volume of opioids they prescribe.

Given that law enforcement and medical board investigators usually don’t have training in statistics (or medicine), they are unable to see that the number of pain patients remains the same, but there are fewer practitioners willing to treat them.

“The Criminalization of Medicine: America’s War on Doctors” was published in 2007, but is even more relevant today.   

“Physicians have been tried and given longer prison sentences than convicted murderers; many have lost their practices, their licenses to practice medicine, their homes, their savings and everything they own,” wrote author Ronald Libby. “Some have even committed suicide rather than face the public humiliation of being treated as criminals.”

Libby wrote over a decade ago about doctors’ homes and offices being raided, DEA agents posing as pain patients to entrap them, and law enforcement task forces being created to target doctors for fraud, kickbacks and drug diversion.

Sound familiar?

I was reviewing a case about a nurse practitioner in Michigan who recently had her license suspended because she prescribed opioids “contrary to CDC guidelines” and “ranked among Michigan’s highest-volume prescribers of commonly abused and diverted controlled substances.”

This unsubstantiated crap put out by the Michigan Board of Nursing and its investigator is unethical and immoral. It should lead to a mistrial in court or dismissal at hearings. 

Fight Fire With Fire

This is an Amber alert for physicians. While pejorative headlines contaminate the discourse, the prescriber’s reputation bleeds away. The Montana Board of Medical Examiners did this in my case, and since I knew that the board was relentlessly after my license for “overprescribing” opioids, I gave up any hope of fairness.

My proposal: Lawyers representing doctors must counter the negative headlines with their own, and doctors should use whatever goodwill is left to rally their staff and patients, counteracting the pressure to testify against the doctor. 

I used what was left of my bully pulpit to save my own license and freedom. How? My assistant assembled my patients in large crowds at my hearings. I also made myself available to the media to counter the narrative put out by Mike Fanning, the board’s attorney, who went so far as to publicly question my sanity.

Fanning’s title was special assistant Attorney General, which told me the medical board works for DOJ in my state. I knew this for sure when DEA agents came to my office and tried to intimidate me.

“Doctor Ibsen, you are risking your license and your freedom by treating patients like these.”

Patients like what?

“Patients who might divert their medicine.”

Might? Isn’t that everyone? What would you have me do?

“We can’t tell you, we’re not doctors.”

My plea to doctors: Let’s reinvent our defense. The DEA and medical boards have a formula. It’s winning. 

We need a new response: Fight back and hold on. Just like with any bully, reveal their game and fight fire with fire.

Dr. Mark Ibsen continues to practice medicine in Montana, but focuses on medical marijuana as a treatment. He no longer prescribes opioids. Six of his former patients have died after losing access to Dr. Ibsen’s care, three by suicide.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

House Panel Seeks Clinical Trials of Kratom

By Pat Anson, PNN Editor

At a time when several states and cities have banned kratom, a powerful congressional committee is recommending that the herbal supplement be studied in clinical trials because of its “potential promising results” in treating chronic pain.

In a report to Congress, the House Appropriations Committee recommends that the National Institutes of Health (NIH) conduct research on whether kratom can be used as an alternative to opioids in treating pain.

“The Committee requests that NIH expand research on all health impacts of kratom, including its constituent compounds, mitragynine, and 7-hydroxymitragynine. The Committee is aware of the potential promising results of kratom for acute and chronic pain patients who seek safer alternatives to sometimes dangerously addictive and potentially deadly prescription opioids.”

The committee also recommended that the Agency for Healthcare Research and Quality (AHRQ) spend $3 million on clinical trials of kratom and cannabidiol (CBD) as alternatives for treating pain, and that the trials be conducted in “geographic regions hardest hit by the opioids crisis.”

The panel said it was concerned that the continuing classification of cannabis as a Schedule I controlled substance was stifling research “at a time when we need as much information as possible about these drugs.”

“The Committee notes that little research has been done to date on natural products that are used by many to treat pain in place of opioids. These natural plants and substances include kratom and cannabidiol (CBD). Given the wide availability and increased use of these substances, it is imperative to know more about potential risks or benefits, and whether or not they can have a role in finding new and effective non-opioid methods to treat pain.”

The committee said the current state of pain management in the U.S. is “often inadequate for many patients” and that additional treatments were needed. It asked that Congress be given an update on the development of non-opioid chronic pain therapies in the next fiscal year.

To be clear, the 346-page report by the House committee is an ambitious “wish list” of hundreds of various projects that may or may not be included in a final congressional spending bill.  But the inclusion of funding for kratom research is significant, given the campaign against kratom by some public health offiicials.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years millions of Americans have discovered kratom and use it as a daily treatment for pain, addiction, depression and anxiety.  

Although kratom is not an opioid, health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition. Last month the CDC said kratom was listed as the cause of death in at least 91 overdoses and the FDA said it discovered dangerous levels of heavy metals in dozens of kratom products.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide.

Ironically, HHS oversees both the NIH and AHRQ, the same agencies the House Appropriations Committee wants to fund for kratom research.