Can Psychedelics Be Used to Treat Fibromyalgia?

By Pat Anson, PNN Editor

A startup pharmaceutical company has announced plans for a clinical trial to see if a psychedelic compound may be useful in treating fibromyalgia.

California-based Tryp Therapeutics is partnering with scientists at the Chronic Pain & Fatigue Research Center at University of Michigan Medical School for the Phase 2a study, which would be the first to evaluate the effictiveness of psilocybin – the psychoactive compound in “magic mushrooms” -- in treating fibromyalgia.

"We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia," Jim Gilligan, PhD, Tryp’s President and Chief Science Officer said in a statement.

"The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients."

The study will evaluate the safety and efficacy of TRYP-8802, an oral formulation of synthetic psilocybin developed by Tryp. The treatment, which will also include psychotherapy, is designed to target pain through neuroplasticity, which alters and reorganizes neural networks in the brain.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia, such as non-steroidal anti-inflammatory drugs (NSAIDs) and gabapentinoids (Lyrica, Neurontin), often prove to be ineffective or have unwelcome side effects.

"Existing treatment options for fibromyalgia are often ineffective and show significant side effects," said Daniel Clauw, MD, Director of the Chronic Pain & Fatigue Research Center.

Tryp plans to submit an Investigational New Drug application to the FDA for the Phase 2 trial in September. Phase 2 studies typically involve a few hundred people with a disease or condition, and are designed to test the safety and efficacy of a treatment.  A much larger Phase 3 study is usually required before the FDA will even consider approval.

Interest in using psychedelics to treat medical conditions has been growing in recent years, primarily as a way to treat depression, anxiety and other mental health issues. Preliminary research suggests that microdoses of LSD, psilocybin and other psychedelics may also be effective in treating pain.

Another pharmaceutical startup – Mind Medicine (MindMed) – recently announced plans to  investigate LSD as a treatment for cluster headache and an unnamed “common, often debilitating, chronic pain syndrome.”

Tryp Therapeutics is focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs. The company recently announced a partnership with the University of Michigan to study synthetic psilocybin as a treatment for neuropsychiatric disorders. Tryp is also working with the University of Florida to investigate psilocybin as a treatment for eating disorders.

LSD, psilocybin and other psychedelics are classified as Schedule I controlled substances, meaning they have a high potential for abuse and currently have no accepted medical use in the United States.

Rare Disease Spotlight: Transverse Myelitis

By Barby Ingle, PNN Columnist  

This month as part of my series on rare diseases and conditions, we’ll look at transverse myelitis (TM), an inflammatory disease of the spinal cord. TM causes pain, muscle weakness, numbness, tingling, and bladder and bowel dysfunction. Severe cases can even result in sudden paralysis. 

Can you imagine being fine one minute and the next being paralyzed and losing control of your bowels?

The most famous person I have heard of having transverse myelitis is Allen Rucker, an author and comedy writer who developed TM spontaneously at the age of 51. Rucker wrote a memoir about becoming paralyzed due to TM: “The Best Seat in the House: How I Woke Up One Tuesday and Was Paralyzed for Life.”

As with many TM patients, Rucker was paralyzed from the waist down and has no control over his legs, bladder or bowel. He will need a wheelchair for the rest of his life. Despite these challenging conditions, Rucker continues to write and uses his communication skills to help others understand what it is like to live with a rare disease.

Transverse myelitis can occur at any age, but most often affects patients between the ages of 10-19 and 30-39. Some people do recover from TM, but the process can take months or even years. Most see improvement in their condition within the first 3 months after the initial attack, giving them a good idea of what they will face long-term.

There are many different causes of transverse myelitis, including viral, bacterial or fungal infections that attack the spinal cord. The inflammatory attack usually appears after recovery from an infection, such as chickenpox, herpes or shingles. TM can also be caused by immune system problems or myelin disorders, such as multiple sclerosis.

Patients who develop transverse myelitis can go through many treatments, including intravenous steroids for days to weeks at a time, plasma exchange therapy, antiviral medication, pain relievers, and drugs used to treat complications. There are some preventative medications to help keep inflammation down, avoid new flares and long-term complications.  

A patient can expect to undergo multiple MRIs of the spine as well as blood testing and possibly a spinal tap to check cerebrospinal fluid. They may also be started on physical therapy, occupational therapy and psychotherapy.

It can be difficult to know the course an individual with TM might take, but they fall into three areas: no or slight disability, moderate disability and severe disability.  The sooner that proper treatments begin for TM, the better the outcomes can be.

If you suspect you might have TM, keep track of when the symptoms started, what they are and how fast they progressed. Note if they presented through pain, tingling or other unusual sensations such as loss of bladder and bowel control or difficulty breathing. A provider will also want to know if you have recently traveled or had any infections or vaccinations.

If you are diagnosed with transverse myelitis, you can find support at the Siegel Rare Neuroimmune Association, a non-profit that advocates for people with TM and other neuroimmune disorders. They are a great resource for those who need assistance for research and daily living. Facebook also has several TM support groups, such as Transverse Myelitis Folks and Transverse Myelitis Society.

We are now halfway through our series on rare diseases and conditions. So far, I have covered transverse myelitis, Paget’s disease, Alexander disease, X-linked Hypophosphatemia, cauda equina syndrome, vulvodynia and Dupuytren's contracture. Next month I will look at Friedreich’s Ataxia.

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.

Terpenes Make Cannabis More Effective as Pain Reliever

By Pat Anson, PNN Editor

A new study may help explain what makes cannabis effective as a pain reliever. It’s not just cannabinoids like cannabidiol (CBD) or tetrahydrocannabinol (THC), but terpenes -- the aromatic compounds that give cannabis its distinctive “skunky” smell. The finding could lead to new ways to boost the potency of cannabis, opioids and other pain-relieving drugs without increasing the dosage.

In experiments on laboratory rodents, scientists at the University of Arizona Health Sciences found that Cannabis terpenes, when used alone, mimic the effects of cannabinoids, including a reduction in pain sensation. When terpenes were combined with a synthetic cannabinoid, the pain-relieving effects were amplified – an “entourage effect” – that reduced pain levels without an increase in euphoria and other side effects.

"A lot of people are taking cannabis and cannabinoids for pain," said lead researcher John Streicher, PhD, a member of the UArizona Health Sciences Comprehensive Pain and Addiction Center and associate professor of pharmacology at the College of Medicine-Tucson.

"We're interested in the concept of the entourage effect, with the idea being that maybe we can boost the modest pain-relieving efficacy of THC and not boost the psychoactive side effects, so you could have a better therapeutic."

Terpenes are found in many plants and are the main component in essential oils. The terpene linalool gives lavender its distinctive floral scent, while citrus trees get their smell from the terpene limonene. Plants create terpenes to lure pollinators, such as birds and insects, and to protect themselves from predators.

Streicher and his colleagues focused on four Cannabis terpenes: alpha-humulene, geraniol, linalool and beta-pinene. They evaluated each terpene alone and in combination with a synthetic cannabinoid that stimulates the body's natural cannabinoid receptors.

In laboratory experiments, researchers found that all four terpenes activated a cannabinoid receptor in the brain, just like THC. The behavioral studies in mice also revealed the terpenes lowered pain sensitivity, reduced pain sensation, lowered body temperature, and reduced movement and catalepsy, a freezing behavior related to the psychoactive effects of cannabinoids.

When terpenes were combined with the synthetic cannabinoid, researchers saw a greater reduction in pain sensation -- demonstrating a terpene/cannabinoid interaction in controlling pain.

"It was unexpected, in a way," said Streicher. "It was our initial hypothesis, but we didn't necessarily expect terpenes, these simple compounds that are found in multiple plants, to produce cannabinoid-like effects."

The study findings were recently published in the journal Scientific Reports. Streicher and his research team still need to confirm if terpenes have an entourage effect when combined with THC and other naturally occurring cannabinoids. Their long-term goal is to develop a dose-reduction strategy that uses terpenes in combination with cannabinoids or opioids to achieve the same levels of pain relief with fewer side effects.

Although the therapeutic benefits of terpenes are not well understood, some cannabis companies are already incorporating them into their products. Lemon Kush, for example, is a hybrid marijuana strain that contains limonene, while the hybrid Blue Dream has a terpene found in blueberries. Terpenes are also being added to chocolate, beverages and many other consumer products.  

Being Judged for My Invisible Disability

By Victoria Reed, PNN Columnist

One of the things that irritate me is when people have complete disregard for disability parking spaces and park in them without a permit.

Recently, my family and I traveled to another state for a wedding. While we were there, we decided to check out a popular outdoor tourist attraction. Being that it was a weekend, the attraction was quite crowded. As we entered the parking lot, it was clear that we would either need to wait for a parking space or leave altogether. We decided to take our chances and wait.

Then I noticed a car parked in one of the disability spaces without the required permit. While the car had been ticketed by the National Park Service, I was a little annoyed because I have a disability placard (prescribed by a rheumatologist), and we could have parked in that space. Or someone else who is disabled could have.

My disability placard has been invaluable to me over the years, as I suffer from at least two of the “invisible” illnesses—rheumatoid arthritis and fibromyalgia. On days when my RA or fibromyalgia is at its worst, I utilize the placard and park in a space that would help minimize my walking distance. Sometimes both conditions work in-tandem to make my life miserable, causing joint pain and muscle pain/weakness.

I know I may not look disabled on some days. I try to put myself together before going out (no offense to those who are unable to), and I don’t use a wheelchair, scooter, cane or walker on a regular basis. I have used wheelchairs and electric scooters in the past while attending sprawling places like Universal Studios, zoos or other venues with my kids or where there would be significant walking involved.

Because I often don’t appear like a person who is disabled, I have received the “looks” from people when exiting my car after parking in a disabled parking space. I’ve also gotten nasty stares when I pull in and don’t hang my disability parking tag right away.

I wish that people would not be so judgmental, but sadly, some are! You never know what a person might be struggling with that’s not readily apparent. I always try to keep that in mind. If a person doesn’t use assistive devices, it doesn’t necessarily mean that they are not needed or mean that a person is completely well. 

Not only is the pain of RA and fibromyalgia a significant issue for me, so is the profound fatigue that accompanies both of these conditions. Some days, even if I’m not having active joint or muscle pain, the fatigue can be nearly incapacitating and make walking (or doing just about anything) difficult. In addition, the fatigue causes shortness of breath. People can’t usually see that.

Another thing that I’ve noticed in this Covid era is the decrease in disability parking spaces as retailers reassign those spaces for drive-up purchase pickup. I don’t have a problem with the drive-up spaces, as I often use them myself on more difficult days, but it’s a little concerning when disability parking spaces are reduced in favor of those. On better days, I like to park and go into stores because moving my body is good for me, regardless of the pain and/or fatigue I might be experiencing that day.

Hopefully, if Covid-19 ever completely goes away, retailers will add back those disability parking spaces that they took. We need those spaces!

It’s possible that someday I might need the regular use of a cane, walker or wheelchair, but until then, having an invisible illness and parking in a disability space will probably get more negative attention than it should. Yes, it bothers me when people judge me and assume that I don’t have a disability, but I will continue to keep my head up and go about my business.

As a chronic pain patient, I’ve learned to be tough, and I’ve had to develop a thick skin about be judged. Their problem is not my problem. However, my problem could someday become their problem! We are all just one accident, injury or illness away from possible disability. 

As for a parking space at that tourist attraction, we got one after about a 10 minute wait. I can’t complain too much about that!

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis.

CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids

By Pat Anson, PNN Editor

An independent advisory panel is warning the CDC that a draft revision of its 2016 opioid guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients.

A 12-page report from the CDC’s Opioid Workgroup was discussed Friday during an online meeting of the agency’s Board of Scientific Counselors (BSC). The 23-member workgroup is composed primarily of physicians, academics and researchers involved in pain management, including some who advised the agency during the drafting of the original guideline.

CDC has not made public the revised draft guideline and has no plans to release it for public comment until later this year. The workgroup, however, has seen the draft and many of its members have issues with it.     

“Overall, many workgroup members felt that much of the supporting text of the guideline was not balanced and was missing key studies. Many workgroup members felt that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain,” the workgroup report states.

“Many workgroup members noted how the guideline has a constant tension between public health benefits versus patient benefits. This issue is minimally addressed in the guideline and comes very late. Workgroup members felt it is important to directly address this tension between risks and benefits to public health versus individual patients.”

Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies and doctors of all specialties.

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.

Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.

We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused.
— Dr. Deborah Dowell, CDC

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline.

Dowell gave a brief outline of the guideline update to the BSC, noting that it’s recommendations are being expanded beyond chronic pain to include acute pain (pain lasting less than one month) and sub-acute pain (pain lasting 1 to 3 months).

She also disclosed the names of the five co-authors who are writing the update, briefly showing their names on a slide. They include Dowell herself, Kathleen Ragan, a CDC Health Scientist; Christopher Jones, PharmD, Acting Director of NCIPC; Grant Baldwin, PhD, Director of Overdose Prevention at NCIPC; and Roger Chou, MD, Director of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which has received billions of dollars in research funding from the federal government.

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The inclusion of Chou as an update co-author is likely to be controversial. As PNN has reported, Chou has been an outspoken critic of opioid prescribing and has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like Dowell, Chou was a co-author of the 2016 guideline.

“It is wildly inappropriate and unethical that someone with strong ties to the anti-opioid industry and who has significant financial conflicts of interest is leading this process,” Amy Partridge, an intractable pain patient, told the BSC. “The evidence review and guidance are therefore both inherently biased and should be struck in their entirety.”

Chou — who is a member of the BSC — acknowledged he has a conflict of interest at the start of the meeting and recused himself. “I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the director's update,” said Chou.

Chou’s recusal apparently only applied to his participation in the meeting, not to his continuing involvement in the guideline update or OHSU’s research.

Dose Recommendations Questioned

Some members of the Opioid Workgroup feel the current draft of the update is “not sufficiently patient-centered,” while others believe not enough attention was paid to disparities in pain care and lack of access to effective, non-opioid treatments.

One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.

Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”

“We certainly are looking at language in the guideline and also looking at feedback about how to better communicate those nuances and their flexibility,” she told the BSC.

Worries About ‘Bad Policy’

Several workgroup members have issues with the recommendation that non-opioid therapies be used for “many common types of acute pain,” because it doesn’t distinguish between post-surgical pain that may require opioids and other types of short-term trauma that could be treated with non-opioid pain relievers. They warned the recommendations for treating acute pain “could be misinterpreted and translated into bad policy.”

The workgroup also took issue with recommended drug testing for anyone prescribed opioids for chronic pain. Their report says false results from urine drugs tests are common and could have “inappropriate negative consequences” for patients, while more accurate and expensive laboratory tests may not be covered by insurance.

Questions were also raised about prescription drug monitoring programs (PDMPs), particularly the use of algorithms and data mining to create risk scores for patients based on their drug history.

It's important to note that the workgroup’s role is strictly advisory. It had no direct role in writing the revised guideline and will not be involved in rewriting it, if changes are even made.

You can watch most of the meeting below (video courtesy of Peter Pischke):

The workgroup’s report drew both criticism and praise during the public comment period. Some speakers believe the guideline can’t be fixed and should be repealed.

“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,” said Margaret Rene Blake, a pharmacist and intractable pain sufferer. “As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers and the system is to repeal the guideline.”

One critic suggested the workgroup volunteers, who were unpaid, were swayed by the pharmaceutical industry.

“The OWG (Opioid Workgroup) comments perpetuate myths disseminated by opioid manufacturers. Claiming that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits is certainly an industry friendly view,” said Adriane Fugh-Berman, MD, Director of PharmedOUT and a PROP board member, who was a paid expert witness in Oklahoma’s lawsuit against opioid manufacturers.

“Several statements in the OWG (report) are just wrong, including the claim that continuing and not tapering opioids avoids risks of poor analgesia, worsening function and suffering.”

Without seeing the revised draft guideline in its entirety, it’s hard to tell if any significant changes have been made to the original guideline. But judging from the workgroup’s report, the changes have been minor so far. The draft guideline continues to maintain that “nonopioid therapies are preferred” for both short and long-term pain, and that doctors should only consider opioids “if expected benefits for pain and function are anticipated to outweigh risks to the patient.”

There is also no indication what the CDC intends to do to persuade states, insurers, pharmacies, doctors and other federal agencies that they should amend opioid policies and laws that are based on the 2016 guideline.

A Matter of Interpretation

By Carol Levy, PNN Columnist

I recently read a post in one of the online chronic pain support groups. “Sue” had just left an appointment with her pain management doctor. She was enraged, so angry about the way the meeting had gone, that she went right to her computer and complained about it.  

“My doctor asked, ‘What do you think about my lowering the pain meds you're on?’” Sue wrote.

“How dare he reduce them!” was her response. Sue said the medications were helping her and the doctor had some nerve to ask. All these doctors want to do is hurt us, she wrote, and if it wasn't for the CDC and FDA, this wouldn’t be happening.

I read her post and was somewhat confounded by her anger. She did not include any information on how the meeting ended. Did he lower her dosage or the number of pills? I could see how upset that would make someone, especially if the drugs were helping.

But he didn't say, “I am going to lower the level of opiates I am giving you.” He said it in a way that seemed, to me, like he meant to open a discussion.

It reminded me of a difficult crossword puzzle I had just completed. It was so frustrating. I had it all done, but for one four-letter word. The clue was “wind.” All I could think of was “blow,” as in the wind blowing, but the letters didn’t fit.

There was a “C” for the first letter but I could not think of one word that started with “C” that fit the clue. No matter what letters I tried, I could not think of any other answer but “blow.”

Finally, I was able to figure out the word. The answer was “coil.”  

“Coil,” I thought. “Oh, for goodness’ sake.”

I was so obsessed with my one interpretation, it never occurred to me to consider another. It wasn't wind, as in the wind blows. It was wind, as in winding a clock or a windy road.

I think we do this often, and not just with medical people. They make a statement or ask a question that seems clear. But to the listener it carries a whole different meaning.

It’s harder when you're right there. Reading about it online made it easier for me to see it as the doctor asking, not demanding or insisting. In the heat of the moment, it may well sound like, “I'm not going to help you anymore. I'm stopping the drugs that have been helping you.”

There are crosswords and cross words. Sometimes we have to stop, take a deep breath, and instead of responding with angry or impulsive words, ask for an explanation.

“Are you asking me about lowering my meds or are you telling me you will?”

 If it’s the latter, it may well be the time to be upset. If it’s the former, it’s time to open the discussion.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.”

A New Option for Young Migraine Sufferers

By Pat Anson, PNN Editor

Migraines can have a devastating impact on children and adolescents. In addition to causing head pain, upset stomachs and visual disturbances, migraine attacks can disrupt school and social activities at a sensitive time in a young person’s life.

Although pediatric migraines are common, affecting about 10% of school-age children and one in five teenagers, treatment options are very limited compared to adults. There are no FDA approved pharmaceutical migraine treatments for kids under the age of 12. That leaves doctors to prescribe migraine medication to children off-label, including a new class of migraine drugs called CGRP inhibitors, which have not yet been approved or studied in young children. 

A small new study suggests there may be a safer and more effective option for young migraineurs: neuromodulation. Research recently published in the journal of Pain Medicine found that Nerivio, a neuromodulation device worn on the upper arm, was more effective in treating acute migraine in adolescents than triptans and over-the-counter pain relievers. Nerivio uses smartphone-controlled electrical pulses to stimulate nerves and disrupt pain signals.

“To my knowledge, this is the first study that directly compared remote electrical neuromodulation and standard-care treatment options in adolescents,” says lead author Andrew Hershey, MD, co-director of the Headache Center at Cincinnati Children’s Hospital Medical Center.

“Migraine in adolescents is associated with poorer performance and absence from school and social activities during a particularly formative time in life. Providing teens with more effective and engaging treatments for migraine can have far-reaching positive effects over the course of their lives.”

Nerivio was developed by Theranica, an Israeli medical technology company that sponsored the study. The FDA approved the device as a treatment for acute migraine in adults in 2019 and recently expanded the label to include children over the age of 12 with episodic or chronic migraine.

THERANICA IMAGE

THERANICA IMAGE

Thirty-five adolescent migraine patients aged 12 to 17 took part in the two-month comparison study. Over-the-counter drugs and oral triptans were used by patients during the medication month, and Nerivio during the Remote Electrical Neuromodulation (REN) month.

Two hours after treatment, over a third (37%) of patients achieved complete pain freedom during the REN phase of the study, compared to just 8.6% in the medication phase. Some degree of pain relief was reported by 80% of patients in the REN phase, as opposed to 57% in the medication phase.

“This study provides evidence that Nerivio may be considered as a first-line acute treatment, especially for adolescents with medication restricting comorbidities or a preference for a non-medication-based treatment,” said co-author Samantha Irwin, MD, a pediatric neurologist at the UCSF Benioff Children Hospital in San Francisco. “The importance of having a non-pharmacologic, discrete, easy-to-use and effective acute treatment in the adolescent armamentarium cannot be overstated.”

Long-Term Effects of Childhood Migraine

Early treatment of childhood migraine is important because there is emerging evidence that repeated headache attacks in children reduce the formation of “gray matter” in parts of the brain that process pain signals, leading to more frequent and severe migraines in adults.   

“We’ve done studies here independent of any pharmaceutical company where we’ve show that the earlier we can intervene with effective therapy and education of patients, the better their long-term outcome,” Hershey told PNN. “So we really have this opportunity to intervene with a child or adolescent that can affect them for their life.

“A device can be as effective as a drug. What I tell patients is that it gives them their own locus of control. Instead of taking a medication and hoping it works, they’re actually controlling the device with their smartphone, and so they can really take control of their headaches, which is ultimately what we want them to do.”    

Nerivio is only available by prescription and is eligible for insurance. When purchased wholesale, the listed price is $599 for a twelve-treatment unit, although buyers can save money by enrolling in a patient savings program, depending on their insurance coverage.  

Theranica is currently recruiting patients for a placebo-controlled study to see if Nerivio may be effective in preventing migraines. The company is also investigating whether the device may help treat other chronic pain conditions besides migraine.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Ending the War on Drugs Probably Won’t Help Pain Patients

By Roger Chriss, PNN Columnist

America’s war on drugs has been running for half a century and calls to bring it to an end are increasing. Lawmakers and public health experts are questioning federal and state policies that criminalize drug use, while the public generally supports less punitive measures to address drug abuse and addiction.

"The war on drugs must end,” said a recent editorial in The Lancet. “Decriminalisation of personal drug use, coupled with increased resources for treatment and harm reduction, alongside wider initiatives to reduce poverty, and improve access to health care, could transform the lives of those affected."

But ending the war on drugs probably won’t help people with chronic painful conditions. That’s because decriminalization of recreational drugs is not necessarily associated with full legalization – as is the case with marijuana -- while legalization of recreational drugs is separate from medical care with pharmaceutical prescriptions.

The debate about how to end the drug war is largely ideological at this point. In the new issue of The American Journal of Ethics, Carl Hart, PhD, author of the book “Drug Use for Grown Ups,” writes with colleagues that laws criminalizing drug use are “rooted in explicit racism.”

"We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation," they wrote.

But bioethicist Travis Rieder, PhD, author of the book “In Pain” about his experience with opioid-based pain management, wrote in the same journal that “ending the war on drugs does not require legalization, and the good of racial justice and harm reduction can be achieved without legalization.”

Yet another view comes from Stanford psychiatrist and PROP board member Anna Lembke, MD, who wrote in the Journal of Studies on Alcohol and Drugs that creating a “safe supply” of drugs by legalizing the non-medical use of prescription medication would be a mistake.

“The expanded use of controlled prescription drugs should not occur in the absence of reliable evidence to support it, lest we find ourselves contending with a worse drug crisis than the one we’re already in. No supply of potent, addictive, lethal drugs is ‘safe’ without guarding against misuse, diversion, addiction, and death,” said Lembke.

The Lancet points to Portugal as an example that other countries should follow. But contrary to common belief, Portugal has not legalized drugs. In Portugal, drug possession of no more than a ten-day supply is an administrative offense handled by so-called dissuasion commissions.

Portugal has not even legalized recreational cannabis. Medical cannabis is legal in Portugal, but only when prescribed by a physician and dispensed by a pharmacy if conventional medical treatments have failed. Personal cultivation of cannabis remains against the law.

Further, neither decriminalization nor legalization necessarily improves racial and social justice. For instance, the University of Washington’s Alcohol & Drug Abuse Institute reports that the legalization of cannabis in Washington state in 2012 has had no impact on reducing racial bias in policing and other disparities in the criminal justice system.

Broad drug decriminalization or legalization would likely have little impact on pain management. Healthcare professionals routinely prescribe medications that are illegal outside of clinical medicine, after weighing the risks and benefits for each patient. Patients are often monitored via pain contracts and drug testing, with some agreements even disallowing cannabis and restricting alcohol use for patients taking medications like opioids or benzodiazepines.

Physicians and pharmacies are under increasing scrutiny from law enforcement, insurers and regulators in the hope of curbing drug abuse. If decriminalization or legalization of drugs leads to more abuse, addiction and overdose, then the scrutiny could increase. So in an unexpected way, an end to the war on drugs could have negative impacts on pharmacological pain management.
 
Supporting an end to the war on drugs is a right and just action. But it would be a mistake to assume that an end to that war will necessarily bring a positive change to pain management. For that, it would be better to support physician autonomy and greatly expanded clinical research into pain management.

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.  

Pain Community Mourns Loss of Patient Advocate Erin Gilmer

By Pat Anson, PNN Editor

Erin Gilmer didn’t fail. The healthcare system failed her.

That’s what hundreds of Gilmer’s friends and followers are saying, as word spreads online about her death last week by suicide at the age of 38. Gilmer was a patient advocate and health policy attorney who intimately knew the problems faced by many chronically ill patients. She was one herself.

Gilmer lived with Type 1 diabetes, celiac disease, rheumatoid arthritis, neuropathy, carpal tunnel, depression and a string of other chronic health problems. According to friends, Gilmer was abandoned by doctors, could no longer work and was on disability. Lacking the financial resources to get good healthcare, she became increasingly despondent about her failing health.    

“I loved you more than you could know. I’m sorry for all the ways I failed. I’m safe now,” Gilmer tweeted @GilmerHealthLaw on July 7. It was her last post.      

“You haven’t failed me. There were many times you saved me. I hope that wherever you are, you’re safe & surrounded by love,” one follower responded.

“I don’t recall any ways you failed, but I treasure all of the difference you made in my life & the lives of many others,” said another.

“Erin, you haven’t failed at all. So many systems have failed you,” another follower tweeted.

In the days before she passed, Gilmer wrote frankly and honestly about her health issues, her posts reflecting a growing sense of finality.

ERIN GILMER

ERIN GILMER

“I wish I could describe how bad the pain is but nothing seems adequate. I keep thinking it can’t possibly get worse but somehow every day is worse than the last,” Gilmer tweeted. “This pain is more than anything I’ve endured before and I’ve already been through too much. Yet because it’s not simply identified no one believes it’s as bad as it is. This is not survivable.”

According to fellow patient advocate Terri Lewis, Gilmer was labeled and shunned by doctors as a complex patient with mental health issues. 

“Like so many others, Erin's life was squandered. The loss of her unique talents, capacity, and learning is just unbelievable to me,” said Lewis. “I am angry that we find it acceptable to foster a system of siloed ‘healthcare’ that continues to reward marginalization and abandonment of persons with chronic multiple comorbidities. The death of Erin and so many like her was predictable, a matter of time in a system perfectly designed to fail chronic care needs. This was no error. The system is working as it is designed.” 

According to her blog, Gilmer received her law degree from the University of Colorado. She began her legal career in Texas as a disability rights attorney for several non-profit organizations. Gilmer also worked and consulted at Stanford University, the Patient Centered Outcomes Research Institute and the Agency for Healthcare Research and Quality (AHRQ). Gilmer moved back to Colorado and launched her own private legal practice in 2012, but was not able to work full time after becoming disabled. 

She turned to advocacy as an alternative — educating doctors and patients about the anxiety and stress many chronically ill patients experience while navigating a broken healthcare system. In one of the last posts on her blog, Gilmer wrote about “betrayal trauma.”   

“If we want people to trust health care, if we want people to heal from the chaos and pain of health care, if we want people to seek out care, we need to both understand the traumas we’ve endured, including betrayal trauma, and implement trauma informed care for all as soon as possible,” Gilmer wrote.

“Patients deserve better. Patients deserve fewer barriers to care and more compassion throughout care. Patients deserve to have their betrayal trauma acknowledged and repaired. Patients deserve to be believed and heard and treated with dignity and kindness.”

The ‘Crazy’ Healing Power of Music

By Cynthia Toussaint, PNN Columnist

As a young person, I don’t remember a time when I didn’t live and breathe music.

In grade school, I couldn’t wait to get to the multi-purpose room for two reasons: chorus to sing my heart out and band to play my beloved flute. I pestered my mother relentlessly to let me start piano lessons before age seven (a family rule) because I loved the way it sounded and couldn’t wait to make the notes on the page come to life.

Then there was my favorite. When Mom brought home the record “Funny Girl”, I knew that I’d never stop singing. It was pure joy, an extension of myself. Indeed, the best part of Christmas each year was receiving a new Barbra Streisand album, a treasure that I cherished to the point of wearing out the grooves.

I grew to be a nonstop, never-gonna-quit singer, dancer and actor. It’s what I lived for, what I was born to do. Nothing was going to stop me – and in the end, nothing really did. While we don’t get to live our dreams with Complex Regional Pain Syndrome, we can hold onto our passions in a different way. And for wellness alone, we ought to.

People gasp when they hear that I was unable to speak for five years due to CRPS, because that’s an unthinkable symptom caused by an unimaginable disease. But those same people overlook the fact that CRPS made me unable to sing for 15 years, like that was something disposable.

When I couldn’t sing, I didn’t get to be Cynthia. Something fundamental and basic was stripped away from me. And with that went my expression and joy.

Lately I’m hearing lots about the healing powers of expressive therapy and how creative pursuits like dancing, painting, writing and acting can unleash “feel-good” hormones (like endorphins and oxytocin) that lessen pain, depression and anxiety. I’ve also come to understand that the part of the brain that drives creativity distracts from the part that controls pain. That’s certainly been the case with me.

Cooler still, partaking in one expressive therapy can lead to the recovery of another. It was soon after writing my memoir that I could feel my body getting ready to sing again. Regaining my voice was nothing short of a miracle and, to this day, I don’t really understand how it happened. My best guess is that through the narrative therapy process I purged negative feelings and wounds, opening a healing space. But in the end, does it matter?

Now that I’ve regained my strong vocal chords, I take every opportunity to express this joy. I sing with bands, in choirs, duets with musicians and a cappella harmony trios. I also love to record – and just finished my second CD titled Crazy, which I dedicated to “women in pain who know they’re not.” 

This album was a real labor of love as I took my time (in fact, seven years!) to record it. The obstacles throughout were many – multiple CRPS flares, a broken elbow that went untreated and undiagnosed for a year, a lupus infusion drug that nearly did me in, and, oh yeah, breast cancer.

For this album, I delighted in choosing songs that took me down memory lane, songs that I loved while growing up and that speak differently to me post-illness. I had to quickly wrap up my last two recordings in December 2019 as the dark chemo clouds loomed.

Then, after becoming an unlikely cancer survivor, I eagerly designed my cover. I hadn’t been on a beach for 35 years and was bald, but that didn’t stop me from being a mermaid, leaning against my fears while having them bolster me to look toward a bright future. 

I want Crazy to bring joy and laughter to those who suffer. I’m hoping this near-and-dear project will inspire us to turn our backs on fear and “impossibles,” reignite our passions and courageously move on.

I still hear from women in pain who are stuck in the elusive search for a cure in hopes of recapturing their past. Here’s the thing – we don’t get to go back.

Our choice is to stay stuck and miserable – or let the “cure” delusion go and partake in things that bring us healing and wholeness. I’m certain that one of the tickets forward is expressive therapy. When we stir our soulful passions, wellness follows.

As a former “triple threat” performer, it’s the expressive arts that continue to inspire me to heal. For you it might be a way different sort of passion. Perhaps nature, animal welfare or the pursuit of justice is your buzz. Bottom line, we all need to find ways to differently recapture what clicks our heels and makes the hair on the back of our necks stand straight. 

Being a long-time member of the Kingdom of the Sick doesn’t exclude us from the pursuit of joy. I know it’s easier said than done when wrangling with the likes of CRPS, migraine or lupus. But it’s essential to living a full, authentic life, one worth seeing the glow of a spectacular sunset.            

I don’t think there’s anything crazy about that.                     

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 19 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.”

Click here to download or order her Crazy CD.

Revised CDC Opioid Guideline Not Expected Until Late 2022

By Pat Anson, PNN Editor

The long wait for the CDC to finally unveil changes to its controversial opioid guideline is going to be longer than we thought.

Even though an update to the 2016 guideline is the main topic on the agenda for a July 16th meeting of the CDC Board of Scientific Counselors (BSC), the agency has no plans to make the revisions public at that time. PNN reported earlier this week that the CDC was “expected to release a long-awaited draft of a revised guideline” during that meeting, but that is incorrect.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” Courtney Lenard, CDC spokesperson, wrote in an email. 

The “Opioid Workgroup” is an independent panel of physicians, academics and patients that was created last year to advise the CDC about revisions to the guideline. The panel had no direct role in rewriting the guideline and has only seen a draft of it.

According to the July 16 meeting agenda, at least three hours have been set aside for the BSC to receive an update on the guideline from CDC staff, followed by a discussion of the workgroup’s report. How such a lengthy discussion could occur without the revised guideline being made public is unclear.

When asked to explain, Lenard said only the “process and progress” of the revised guideline would be discussed. She also indicated the public may not see a draft version in the Federal Register until late this year, with the final, revised guideline not expected until late 2022.

“CDC anticipates that the draft updated Guideline will be posted for public comment by the end of 2021. This will provide another critical opportunity for diverse input from the public,” Lenard explained. “In 2022, after the public comment period has closed, CDC will revise the draft updated Guideline. CDC takes public comment seriously and will carefully consider this input while finalizing the update to the Guideline. Release of a final, updated Guideline is anticipated to occur in late 2022.”

People in pain and their advocates have been calling for major changes to the guideline ever since its 2016 release. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended doses and limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide. While the CDC has acknowledged the problems the guideline has created, the agency had dragged its feet on offering solutions or making revisions.

“The refusal of CDC to make detailed interim reports on its progress in ‘re-writing’ their 2016 opioid guidelines was also evident in their February 2021 meeting of the Board of Scientific Counselors,” said patient advocate Richard “Red” Lawhern, PhD. “If repeated in the July 16th meeting, I would personally regard such a policy to be a major failure of process and public transparency, creating potential grounds for a federal lawsuit on grounds of agency fraud and malfeasance.”  

It cannot be overstated the amount of suspicion and distrust there is for the CDC in the pain community. A recent PNN survey of over 3,700 patients, doctors and caretakers found that over 90% believe the guideline did not improve the quality of pain care and failed to reduce opioid addiction and overdoses. Three out of four believe the entire guideline should be thrown out.

When asked if the CDC could be trusted to handle the revision of the guideline in an unbiased, scientific and impartial manner, over 89% said no.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

How Chronic Pain Can Lead to Autoimmunity Problems

By Forest Tennant, PNN Columnist

Every chronic pain patient must know and understand autoimmunity and how to combat it. Research on chronic pain has unequivocally determined that the chronic inflammation and tissue destruction caused by a painful disease or injury will produce autoimmunity.

Autoimmunity is a biologic phenomenon in which certain antibodies in the blood -- called autoantibodies -- turn against the body and attack one’s own tissues. Autoantibody means “self-attack.” This is in stark contrast to “immunity” which means antibodies only attack an invading virus, bacteria, poison or contaminant to protect the body.

Chronic pain that causes inflammation and tissue degeneration generates cellular destruction that can shed tissue particles into the blood stream. These tissue particles are considered foreign and unwanted by the body’s immune system, so it makes autoantibodies against them. Unfortunately, these autoantibodies may then attack normal tissue, giving the patient unexpected symptoms and more pain.

The symptoms and sequelae of autoimmunity can be mysterious and overwhelming. Such disorders as traumatic brain injury, Ehlers-Danlos Syndrome, adhesive arachnoiditis, post-viral, and stroke are particularly prone to the development of autoimmunity.

Although antibodies may attack any tissue in the body, autoantibodies seem to attack the soft tissues such as membranes around organs, ligaments, cartilage, small nerves and intervertebral discs. Another common target is the body’s natural immune protection system, including lymph nodes, thymus gland, mast cells and spleen.

The complications of autoimmunity usually begin without warning. Common clinical manifestations of autoimmunity and the presence of autoantibodies include allergies, skin rash, fibromyalgia, psoriasis, thyroiditis, carpal tunnel syndrome, and arthritis of the joints including the temporal mandibular, elbow and hand joints.

Serious painful and life-threatening autoimmune conditions may also occur, which include the kidney (glomerulonephritis), liver (hepatitis), nerves (neuropathy), spinal canal (arachnoiditis), adrenal gland and the pituitary gland. We now believe that autoimmunity, along with excess neuroelectric stimulation, to be the cause of Intractable Pain Syndrome (IPS).

How To Tell If You Have Autoimmunity

Every chronic pain patient needs to do a self-assessment to determine if their basic pain problem has caused autoimmunity. A failure to control autoimmunity will likely result in progressive complications, misery and probably an early death. As with most other medical conditions, the earlier the recognition, the better the control, suppression and outcome.

Patients should review the following list of some common autoimmune symptoms or conditions. If you have two or more, an assumption can be made that you have autoimmunity and must take actions to control and suppress it:

  • Joint pain

  • Carpal tunnel

  • Histamine episodes or mast cell stimulation

  • Cold hands (Raynaud’s)

  • Allergies

  • Mild recurring fever

  • Neuropathy

  • Medications stop working

  • Irritable Bowel Syndrome (IBS)

  • Food or Medication Sensitivity

  • Hashimotos Thyroiditis

  • Brain Fog

  • Fibromyalgia

  • Diarrhea, gastric upset, heartburn

  • Periodic flushing and itching

  • Herniated disc

  • Constipation

  • Psoriasis

  • Exhaustion and Weakness

If you have two or more of these conditions, a laboratory blood test can help confirm it. Autoimmunity and its close association with chronic inflammation, immune suppression and allergy will almost always result in elevations of one or more of the following blood tests:

  • C-reactive protein (CRP)

  • Lymphocytes or eosinophiles

  • Anti-nuclear antibody (ANA)

  • Erythrocyte sedimentation rate (ESR)

  • Interleukins-cytokines       

  • Thyroid peroxidase antibodies (TPO)

  • ASO Titer

  • Tumor necrosis factor

Automimmunity may also result in decreased immunoglobulins and an altered albumin-globulin ratio.

At this time there is no specific, published treatment for chronic pain-induced autoimmunity. Based on our early investigations, we recommend patients take vitamins, supplements, low dose corticosteroids, low dose naltrexone (LDN) and hormone therapy to control and suppress autoimmunity. Further details can be found here.  

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

The War on Drugs Comes to the Doctor’s Office

By Mike Ludwig, Truthout

Ashley* lived with addiction and anxiety for years, but she was in recovery and making progress in 2017 after finding treatment at Jay Joshi’s clinic in northwestern Indiana. Joshi was known as a pioneer of telehealth visits for addiction patients that became widely used during the COVID pandemic, an expansion that lawmakers and the American Medical Association (AMA) are now pushing to make permanent.

Joshi prescribed Ashley buprenorphine, a standard for treating opioid addiction and preventing overdose. Untreated mental health conditions can play a role in drug addiction that is often overlooked, so Joshi set Ashley up with a psychologist through a telehealth service. On November 21, 2017, Ashley was at Joshi’s office for a telehealth therapy appointment with her psychologist when Drug Enforcement Agency (DEA) agents arrived with a search warrant.

At the time, Joshi was unaware that an undercover DEA agent had posed as a patient at his office to build a drug trafficking case against him. Agents took Joshi to a local police station for hours of questioning, where Joshi surrendered his DEA registration that allowed him to prescribe controlled substances — including buprenorphine.

When he returned from the police station, Joshi said Ashley was deeply traumatized. Ashley told Joshi that she protested the interruption of her therapy appointment, so a DEA agent pulled out a gun and ordered her onto the ground.

In grand jury testimony, former employees-turned-witnesses described the young primary care physician’s practice as sloppy and his patients as “addicts,” a deeply harmful and stigmatizing term for patients in recovery. Joshi was accused of operating a “pill mill” in the local media, a claim Joshi says was manufactured by the DEA.

Ashley and other patients were blacklisted by other local doctors, and without a buprenorphine prescription, Ashley relapsed and suffered fatal overdose. Stephanie, another patient who had stabilized and quit using heroin under Joshi’s care, also lost her prescription to buprenorphine. She soon died of an overdose after returning to heroin.

“Any patient who was associated with me or had my DEA registration number on their prescription history, other physicians didn’t want to see them,” Joshi said.

Opioid Prescribing Plummets as Overdose Deaths Rise

Since the early 2000s, rising rates of fatal drug overdoses breathed new life into the failing war on drugs. As they have during drug scares of the past, the government and mainstream media declared an “epidemic” of opioid addiction, and the crackdown on painkiller prescribing that followed injected the DEA — the federal law enforcement agency charged with waging the drug war — deep into the medical system. Opioid painkiller prescribing dropped sharply as a result, but the number of overdose deaths continued to rise before skyrocketing during the COVID pandemic.

To understand the crackdown, Truthout obtained multiple DEA search warrants and court records detailing law enforcement efforts to shut down pharmacies and clinics, and interviewed chronic pain patients and their advocates, doctors, researchers, pharmacists and people recovering from opioid addiction across the United States. Their advocacy and research are poking big holes in longstanding media narratives linking painkiller overprescribing of the past to rising rates of fatal drug overdose today.

A close look at the policing of opioids reveals a common theme of the war on drugs: Policymakers and drug police are harming the same people they claim to help. Like the drug war, the painful side effects of the opioid crackdown disproportionately fall on lower-income people and people of color, whether they use opioids for any reason or simply seek treatment for chronic pain. The prescribing crackdown appears to be exacerbating existing inequities in access to health care and addiction treatment, one reason why rates of fatal overdose are rising fastest in Black communities.

“I have seen how, in these public health crises, the people we sort of want to help become stigmatized and end up losing access to care,” said Kate Nicholson, a former civil rights attorney for people with disabilities and pain patients who founded the National Pain Advocacy Center, in an interview. “The way in which we wage the drug war disproportionately against communities of color means that they are likely to face much greater barriers to health care.”

Over the past decade, drug police began plundering data from private medical records services and statewide prescription monitoring databases to digitally surveil doctors, patients and millions of prescriptions. Often using federal prescribing guidelines that became a national controversy as a reference, drug cops with no formal medical training search for “red flags” in prescribing records, such as how far a patient travels to receive treatment or the total volume of controlled substances prescribed by a provider.

The investigations have led to raids on hundreds of clinics and pharmacies across the country. In some cases, doctors and pharmacists strike plea deals for reduced sentences. In other cases, respected physicians, pharmacists and addiction specialists are caught in the dragnet and forced to fight the DEA in court.

Doctors and pharmacists became increasingly wary of prescribing and dispensing opioids or even agreeing to treat patients prescribed opioids for chronically painful conditions in the first place. Others had their registrations to prescribe controlled substances revoked by the DEA pending rulings by the agency’s own administrative courts, or they closed their practices in fear of being raided and charged with drug trafficking.

In many cases, patients are left with nowhere to turn, especially if they are low-income and reside in areas with few medical providers to begin with. A 2019 study by the University of Michigan found that 40 percent of health care providers refused to see any new patients prescribed opioids.

Along with prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in 2016 that were widely misapplied and led to misguided restrictions on opioid prescribing in dozens of states, the law enforcement crackdown left patients living with chronic pain without medications they rely on, forcing some toward illicit opioids, such as heroin and fentanyl, which vastly increase the risk of overdose. Others die by suicide.

“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal,” Nicholson said. “People are not just being force-tapered [off medication] … they can’t even get health care anymore, just because they need a prescribed opioid to treat pain.”

Both the legal and illicit markets for prescription painkillers shrank as a result of the crackdown and regulatory moves by the DEA. Illicit drugs such as heroin and counterfeit pills containing potent synthetic opioids replaced prescription painkillers in the illicit market. Opioid prescribing rates have plummeted since 2012, but rates of fatal drug overdose increased for years before briefly leveling off in 2018 as policymakers worked to make treatment more accessible.

Overdose deaths began rising again in 2019, and then the COVID pandemic hit, isolating patients and drug users from friends, family and health supports.

From October 2019 to October 2020, the number of overdose deaths recorded by the CDC surpassed 92,000, the highest level in decades.

I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal.
— Kate Nicholson, National Pain Advocacy Center

There are multiple factors and drugs besides opioids (methamphetamine, for example) behind the overdose epidemic. CDC overdose data is not always accurate, and overdose deaths often involve multiple drugs, including alcohol. Research shows that only a small percentage of overdose deaths are caused by prescription opioids alone.

Illicit drugs containing fentanyl are driving the historic rates of death in part because, unlike prescription drugs, they can vary widely in potency, particularly when law enforcement disrupts the supply. A 2020 study found that 57 percent of 2,887 military veterans who died of overdose or suicide had a prescription to painkillers that was cut off by their doctors.

“I believe that a lot of the industrial binary focus on stopping opioid prescriptions reflects a belief that that will somehow stop overdoses from happening … that if we just stop these patients from receiving the pills they are on, they will be protected,” said Stefan Kertesz, a physician and professor of preventative medicine at the University of Alabama who is studying links between reductions in prescribing and suicides. “That presumption just has not held up, so far.”

At the same time, the government has been slow to lift barriers to the most effective medications for treating opioid addiction and preventing overdose, methadone and buprenorphine, which are heavily scrutinized by police and surveilled by the DEA because they are also prescription opioids.

Nationally, less than 6 percent of doctors are allowed to prescribe buprenorphine under a special federal waiver that medical experts and advocates say must be removed to save lives. The waiver takes a day or so to obtain, but advocates say many doctors don’t bother due to the stigma around treating people with opioid addiction. Like Joshi, numerous doctors who do prescribe buprenorphine have been targeted by the DEA.

A study released in May by researchers in Oregon found that one in five pharmacies in counties with high rates of opioid overdose refuse to dispense buprenorphine. The problem is especially prevalent among independent pharmacies, which are often targeted over large companies by drug cops seeking out the latest “pill mill” to bust. Patients recovering from addiction say buprenorphine is often difficult to access even when it’s stocked by a local pharmacy due to stigma reinforced by fear of law enforcement.

A Safer Drug Supply Is Criminalized

In the final days of the Trump administration, James Carroll, President Trump’s drug czar, boasted that the “prescription opioid epidemic is now over.” A major decrease in opioid prescribing and related overdoses, Carroll said, was one of the administration’s major achievements. Critics were irate. How could the Trump administration claim victory when overdose deaths were ballooning on their watch?

Six months earlier, the AMA warned the Trump administration that the overdose crisis had never just been about prescription opioids, and the nation is now facing an unprecedented “multi-factorial” crisis driven by drugs such as illicit fentanyl. The government could no longer view the crisis through a “prescription opioid-myopic lens.”

Moreover, chronic pain patients are harmed by the crackdown and the CDC’s prescribing guidelines, which caused large numbers of patients to be forcibly tapered off their medication or cut off altogether, often against their will.

“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none,” Kertesz said. “That’s crucial.”

Kertesz pointed to a new study showing that the net effects of policies that encourage doctors to lower the dose of opioids prescribed to patients are uncertain, but rapid discontinuation of opioid therapy is associated with increased risk of overdose and suicide.

Abrupt stoppage of opioid therapy has become the “norm,” Kertesz said, and those who argue that policies aimed at decreasing opioid prescribing over the past decade simply represent more “judicious prescribing” practices are misleading the public.

“There are 8 to 10 million people on long-term opioids, and a meaningful number of those people actually need to be on them, so setting up a system that by design abandons 1 to 10 million patients is not a good thing, but we have set that up,” Kertesz said.

“We have now set up incentives for doctors and pharmacists to avoid care for those people, many of whom have disabilities.”

There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none.
— Stefan Kertesz, MD, University of Alabama

In 2018, senior analysts at the CDC revealed that for years, the number of overdose deaths the agency attributed to prescription opioids was vastly inflated due to problems with data collection classification. For example, deaths caused by illicit fentanyl were blamed on the prescription form of fentanyl, which is often used in emergency rooms.

Overdoses involving a combination of drugs were also misclassified. Last year, researchers concluded that, for over a decade, “millions of Americans” were “misled” by the CDC, politicians and the media to believe that the drug overdose crisis was driven by deaths caused by prescription opioids.

Patients prescribed opioids to treat long-term chronic pain are organizing across the country to overturn the CDC guidelines, and the debunking of CDC data and the AMA’s statement validated their cause. In interviews, multiple chronic pain patients said prescription opioids help them live more normal lives, but their lives became collateral damage of the war on opioid prescribing. Patients report that doctors refuse to treat them and pharmacies won’t fill their prescriptions, leaving them in disabling pain. Mothers are punished by hospitals after childbirth and even charged with crimes for continuing opioid therapy prescribed by a doctor during pregnancy.

“Opioids can be used safely during pregnancy, and we also know that when the response is immediately punitive or the application of the criminal legal system, there is actually far worse outcomes for babies and families, instead of being able to work that out with their doctor,” said Dana Sussman, deputy executive director of the National Advocates for Pregnant Women, in an interview.

Chronic pain patients and their advocates argue that the narrative linking opioid prescribing to the overdose epidemic is a “hoax,” and they are engaged in a pitched media battle with the “anti-opioid zealots” who pushed the CDC to discourage long-term opioid prescribing for anyone besides cancer patients and people dying in hospice.

Advocates point to research showing that rates of fatal drug overdose  correlate with economic decline  in many communities and have been rising rapidly since the late 1970s, not the mid-1990s when painkiller prescribing became more liberal thanks to campaigns by drug companies that have garnered plenty of headlines.

The prescribing debate is extremely emotional, with each side attacking the other over credentials and alleged ties to the pharmaceutical and biomedical industries. (Kertesz said he was attacked in the media by an “expert in the field” for simply announcing a study on deprescribing and suicides. “Attacking investigators in the absence of any knowledge of their work would not be customary behavior in any area of medicine,” he said in an email. “But in this topical area, it is.”)

“The way tapering is happening in the real world is just horrible, even for people who are using their medication appropriately,” Nicholson said.

‘Those Patients Went Through Hell’

As an addiction specialist working at an emergency room and poison control center in Ohio, Ryan Marino has plenty of experience on the front lines. The narrative that overprescribing is causing an overdose crisis is clearly overblown, Marino said, because reductions in prescribing has not brought down deaths.

Marino says he often sees patients who were prescribed high doses of opioids for years until their medication was abruptly tapered or cut off after CDC prescribing “guidelines” became public policy and even law in some states.

“Those patients went through hell … naturally, some turned to street drugs because it is so miserable to have opioids cut off, whether you have addiction or not,” Marino told Truthout. “Seeing those patients has cast an additional shadow over this overdose epidemic that we are seeing, because the over-reactionary response is now creating additional harms.”

Marino said the manufacturing and dispensing of opioids can be a real money-maker in a for-profit health system, and overprescribing played a role early on in the crisis. At the same time, prescription drugs are much safer to use than illicit heroin and fentanyl. Marino said there are good arguments for access to a safe supply of opioids — including prescription heroin for people at high risk of overdose — because people using regulated opioids under medical supervision are far less likely to die.

“We need some sort of regulation [of prescribing], but the oversight the DEA provides seems more in line with reducing prescribing than ensuring that prescribing is appropriate and ensuring that people have access to prescriptions,” Marino said. “The reality is, most people who were using Oxycontin never wanted to switch to heroin, and people who were using heroin never wanted to switch to fentanyl.”

Kertesz, who has worked closely with low-income and houseless patients, also takes a nuanced view of prescribing. Like Marino, Kertesz said there were problems with overprescribing in the past, when medications were heaped upon patients instead of affording them more holistic care.

However, abruptly cutting patients off from medicines they depend on can cause all sorts of problems, particularly for people who have trouble consistently accessing health care in the first place. Doctors must make prescribing decisions based on the particular needs of a patient, but the crackdown has siloed prescribing as either “appropriate” or potentially illegal.

“We have now set up an entire system to push a change to care that does not have evidence for being safe or effective for patients,” Kertesz said.

For example, law enforcement often sees a “red flag” when patients are prescribed high doses of opioids or combinations of controlled substances, even when the prescriber is simply continuing the patient on a long-term regimen. While scrutinized by drug police as a sign of criminal activity, Nicholson said some patients benefit from drug combinations under appropriate medical supervision.

Kertesz said assuming something “criminal” is going on when patients are prescribed higher doses of opioids or more than one psychoactive drug at a time is “a big leap.” The same goes for other “red flags” drug police look for in statewide prescribing databases and records kept by pharmacies.

“A patient who has filled a script in two pharmacies, or a patient who has traveled a distance … anybody who has multiple complex needs is already suspect, anyone who is rural by definition is suspect,” Kertesz said. “Pharmacists are trying not to lose their jobs, so they transfer all this stigma and burden to patients.”

There is a difference between “drug dependence” and “drug addiction.” Addiction is characterized by impulsive drug use despite adverse consequences. Physiological drug dependence results from the continued use of many medications — not just opioids. Addiction is rare in patients prescribed opioids for pain, and while long-term use can create dependence, the benefits can also outweigh the harms. People living with opioid addiction may also be seeking relief from untreated pain, trauma or mental anguish.

Either way, abruptly cutting people off from opioids is dangerous. That’s why methadone and buprenorphine are prescribed for opioid addiction and dependence. Both drugs stabilize patients and stave off painful withdrawal symptoms, which is crucial for preventing overdose.

Advocates say the nuance is lost on the DEA and other law enforcement agencies. Drug cops are laser-focused on opioid “diversion,” the idea prescription opioids are being sold and used outside of their intended purpose. Data on diversion varies by source; a 2017 federal survey found that less than 11 percent of people who misused prescription opioids bought them on the street or stole them from a pharmacy or medical facility.

If the rest are “misusing” their own prescriptions or obtaining them from friends and family — an idea that often offends pain patients — then anti-diversion efforts are effectively targeting prescribers and patients themselves.

For years, the government and mainstream media claimed diversion was the source of the overdose crisis, even as the data began telling a much different story. There is plenty of anecdotal evidence, for example, that buprenorphine is usually diverted to people living with addiction. Vermont recently decriminalized possession of buprenorphine without a prescription for that reason.

The crackdown on diversion created grey areas that turned doctors and pharmacists into suspected drug dealers and patients into suspected criminals. In an ironic way, it worked. Pills became harder to find on the street, but reducing the supply did nothing to treat chronic pain or addiction. Overdoses involving illicit opioids are surging, and a growing chorus of drug users and advocates declare that “every overdose is a policy failure.”

The DEA did not respond to a list of questions by the time this article was published.

‘They Look at Prescribing as a Crime’

Joshi ran a general medical practice in Indiana, and he prescribed opioids for chronic pain as well as addiction. The DEA claimed Joshi was writing more prescriptions for controlled substances than most doctors in Indiana; Joshi says he served a population with serious medical needs.

It was the undercover DEA agent’s job to pose as a “drug seeking” patient and catch Joshi in the act of prescribing and secretly record it on video. Joshi says he tended to trust his patients, but trusting the undercover agent was his downfall. He also suspects a former employee wrote fraudulent prescriptions before becoming an informant for the DEA, although he has been unable to prove it.

“They are transplanting people in the health care field as a drug-dealing ring, so I am the captain drug dealer; you snitch on me and you go free,” Joshi said.

Terrified, Joshi accepted a plea deal after he was indicted on multiple drug charges. However, the DEA’s case against him shifted over time and relied on inconsistent witness testimony, leaving a federal judge frustrated when the time came for sentencing, according to a review of court documents.

The DEA accused Joshi of recklessly prescribing controlled substances, but prosecutors were unable to produce evidence that his patients did not have legitimate medical needs for the drugs Joshi prescribed. Multiple patients testified that Joshi’s practice made serious improvements in their lives. A day before Joshi was indicted, his clinic was recognized by the National Committee for Quality Assurance for “patient-centered, coordinated care.”

“A lot of people have it a lot worse than I do; there really wasn’t any evidence in my case,” Joshi said. “They essentially made a bunch of false statements.… Just the act of prescribing, it was construed as a crime. They don’t look at the clinical decision-making behind a prescription, they look at prescribing as a crime.”

A young doctor with a new practice and a child on the way, Joshi admits that he made mistakes. After losing his registration to prescribe controlled substances, Joshi says he unknowingly broke state rules by hiring nurse practitioners to write prescriptions for his patients. He also wrote a handful of prescriptions under another doctor’s name. Joshi says he tried to find workarounds out of concern for his patients. He did not want their “continuum of care” to be interrupted, but the judge saw a violation of the law.

“I tried to do what was right for my patients, but that was a deviation against the regulatory policies,” Joshi said.

Joshi was sentenced to 15 months in prison for writing an unnecessary prescription to an undercover DEA agent. He got out a few months early on good behavior. By the time he was sentenced, many of his patients were receiving the same treatment they had received from Joshi from other doctors.

Stephanie and Ashley were not so lucky. Both women overdosed and died after law enforcement suddenly interrupted their medical care and their safe supply of medication ran out.

*Ashley’s name has been changed to protect her identity.

This article is part of Truthout's series, "The Policing of Pain: Inside the Deadly War on Opioids."

Copyright © Truthout. Reprinted with permission.

AMA Says CDC Opioid Guideline Still Harming Pain Patients

By Pat Anson, PNN Editor

It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline.

The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain.

Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.”  

Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result.

To date, all of this hand-wringing has changed nothing, as the AMA’s new president recently acknowledged in an exclusive interview with PNN.

“Reports we get from patients and physicians suggest that problems remain. Despite CDC acknowledging that its guidelines should not be used as hard thresholds, there has been almost no effort by state legislatures, health insurance companies, pharmacy chains, or PBMs (pharmacy benefit managers) to evaluate the harmful effects of these one-size-fits-all laws,” said Gerald Harmon, MD, a South Carolina physician who was elected AMA president last month.

“The AMA continues to receive reports that the laws are used to deny, for example, prescriptions for opioid therapy for patients with cancer or in hospice as well as long-time, stable patients with chronic pain.”

DR. GERALD HARMON

DR. GERALD HARMON

Not only has the guideline harmed innocent patients, it failed to achieve its main goal of reducing the risk of opioid addiction and overdose. Opioid prescriptions have been cut to levels not seen in 20 years, while overdoses soared to record highs, fueled largely by illicit fentanyl and other street drugs, not pain medication.

Guideline Meeting

This month we may finally learn what the CDC intends to do after five years of its failed public health experiment, which has been conducted with virtually no effort by the agency to measure its impact on patients. On July 16, the CDC is expected to release a long-awaited draft of a revised guideline during a meeting of its Board of Scientific Counselors (BSC).

(Update: On July 8th, PNN was notified by CDC that the draft guideline would NOT be made public at the July 16th meeting, even though the agenda indicates most of the day will be spent discussing it.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” CDC spokesperson Courtney Lenard wrote in an email, adding that the public may not get a chance to see the updated guideline until late this year.) 

Although the CDC’s review of the guideline has been underway since 2019, the agency has disclosed no details about its plans, which may include new treatment recommendations for short-term acute pain, migraines and other chronic pain conditions. Even the AMA is in the dark about what the CDC is planning.

“Without seeing a specific proposal, we can’t speculate on what CDC might be considering. We will continue to work with CDC to ensure that any recommendations respect and support care for patients with pain. This includes encouraging CDC to make any drafts open to the public for comment to ensure that any revisions or additions do not make the same mistakes as the 2016 Guideline,” said Harmon.

One of the “mistakes” the CDC made was releasing the guideline during a secretive, ham-handed webinar. The agency also refused to disclose the names of its outside advisors, which included members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP).  

As recently as last year, the CDC declined to release memos, conflict-of-interest statements and other communications related to the 2016 guideline. Nearly 1,500 pages of documents provided to PNN under a Freedom of Information Act request were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank. 

The CDC is being a bit more transparent this time around. Early in its deliberations, the agency asked for and received nearly 5,400 public comments, most of them from patients who blame the agency for their poorly treated pain. The CDC also made public the identities of a diverse group of physicians, academics and patients appointed to an “Opioid Workgroup” that is advising the agency. Notably, the group includes no members of PROP.

The CDC has not yet disclosed who is writing the guideline revision, although early indications are that at least one of the original three authors is involved again.

“The AMA’s focus will be to continue to advocate that CDC revise its guidelines in an open, transparent manner,” said Harmon. “We continue to urge that CDC specifically remove recommendations tied to hard thresholds and make clear that its recommendations should not be used in state laws or policies implemented by health insurance companies, pharmacy chains, or PBMs.” 

Once a draft of the revised guideline is completed, there will be another public comment period later this year. The CDC may not finalize and release the updated guideline until early next year.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

States Need to Protect Pain Patients From Uncaring Pharmacists

By Leslie Bythewood, Guest Columnist

The unthinkable just happened again.

A Walgreens pharmacist got away with refusing to fill my prescriptions. It’s the second time that has happened to me at a retail chain pharmacy; the first time was at a CVS pharmacy.

The Walgreens pharmacy manager called and said she would not be able to fill the two prescriptions my board-certified physician had submitted electronically; despite the fact my health insurance had given prior approval for the medications and the pharmacy has been filling them month after month since December 2020.

Contrary to my physician’s best judgment and clinical decision making, this new head pharmacist suddenly decides she cannot fill the prescriptions because:

  • The prescriptions are not in keeping with good-faith dispensing

  • The prescriptions are not appropriate or safe to dispense

  • The pharmacy’s therapeutics committee red-flagged the prescriptions as being too high a dose

  • North Carolina limits the number of tablets that can be dispensed each month

  • Filling the prescriptions goes against the pharmacist’s professional judgment

When I realized that my pharmacist would not fill the prescriptions and refused to even discuss the matter with my doctor, I wasted no time filing an electronic complaint with the North Carolina Board of Pharmacy, hoping for some recourse short of having to get the prescriptions filled at another pharmacy.

But little did I know about a North Carolina Board of Pharmacy rule entitled “Exercise of Professional Judgment in Filling Prescriptions.” That esoteric rule says a pharmacist “shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her professional judgment.”

It also states that a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgement, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.”

Federal law also gives pharmacists a “corresponding responsibility” not to fill a prescription for controlled substances if they believe it is “not in the usual course of professional treatment.”

Basically, the Walgreens pharmacist had the audacity to call into question the validity of my prescriptions being for a legitimate medical purpose, which not only is an insult to my physician, but second-guesses and overrides his many years of medical judgment and authority.

Worse yet, the North Carolina Board of Pharmacy agent I spoke with said that “refusing to fill the doctor’s prescriptions is not a violation of the Pharmacy Practice Act.” She went on to say the board cannot force the pharmacist to fill a prescription if the pharmacist is not comfortable doing so.

Bottom line: In North Carolina and many other states, the patient and doctor have no recourse and no avenues for appeal if a pharmacist refuses to fill a prescription. The only path forward is to have the doctor submit the prescriptions electronically to another pharmacy.

What I find so unconscionable about this whole ordeal is that it doesn’t seem to matter one iota to the uncaring pharmacist that I am a certified pain patient and that my doctor’s prescriptions are entirely legitimate and medically necessary, as has been documented in my medical records.

Nor did it matter that I’ve been on the same opioid strength since December 2020 without any adverse side effects, or that I am highly tolerant of my medications (a physiologic state that does not equate with psychological addiction) and have no history of overdose, substance abuse disorder, misuse or addiction. 

The pharmacist’s ability to get away with overpowering my doctor with unsound, medically unsafe arguments is exactly why we need to enact laws at both the state and federal level to protect pain patients from this type of abuse.

Leslie Bythewood is a freelance writer who lives in North Carolina. Leslie has intractable cranial pain syndrome caused by idiopathic severe chronic migraines and clusters.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.