FDA Seeking Public Comments on Kratom

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is seeking public comments on the medical use and abuse of kratom. In a notice published Friday in the Federal Register, the FDA said the comments will be reviewed as it prepares a response to the World Health Organization (WHO), which is considering whether to place international restrictions on kratom and six other psychoactive substances.   

Kratom comes from the leaves of the mitragyna speciosa tree 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 to self-treat pain, anxiety, depression and addiction. The FDA has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk and should be controlled. The annual assessment will begin in October and U.N. members have been invited to submit their recommendations.

Although the FDA said the U.S. will defer from making any immediate recommendations to WHO, the notice in the Federal Register makes plain that the agency still has a dim view of kratom. It makes no mention of the medical benefits many kratom users get from the herbal supplement.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

— FDA

“Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances,” the FDA said.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom has been reported to have both narcotic and stimulant-like effects.”

The American Kratom Association (AKA), a group of kratom vendors and consumers, said FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. The AKA is urging kratom consumers to submit positive comments about the herbal supplement.  

“The comments should be focused on the experiences that kratom consumers have had with kratom and how it has benefited them in terms of improving their quality of life, to reduce pain, to reduce anxiety and depression, to wean off of opioids, and how kratom has saved their lives,” Mac Haddow, an AKA lobbyist, said in a video. “We want the WHO to know the powerful experiences that people have had. We want to protect kratom, not only here in the United States, but also around the world.”

There’s an August 9 deadline for comments, which can be submitted here.

Asked if the FDA requested WHO to review kratom, a spokesperson told PNN the agency “does not determine for the U.S. government which substances shall be proposed” for review. WHO reviews can be requested by any member countries that are signatories to international drug control treaties.

Kratom’s legal status varies around the world. Thailand recently decriminalized kratom and will make the plants legal to grow and export in August. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Kratom sales are legal in most U.S. states, although some states and communities have banned it. The FDA recently seized 37 tons of kratom from a vendor in Florida for alleged violations of a federal law that prohibits the sale of adulterated dietary supplements.

A federal effort in 2016 to ban kratom nationwide failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew a request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat. A top HHS official later said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

AMA: Pain Patients ‘Need To Be Treated as Individuals’

By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“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 NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“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 Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”

Insomnia Drugs Risky When Taken With Opioids

By Pat Anson, PNN Editor

Medications commonly prescribed to treat insomnia significantly increase the risk of death for older adults if the drugs are taken with opioids, according to new study.

Zopiclone, zaleplon and zolpidem – collectively known as “Z-drugs” – are sold under brand names such as Ambien, Lunesta and Sonata. Z-drugs are sedative-hypnotics and act in a similar way as benzodiazepines, but are considered safer because they belong to a different class of medication.

But after reviewing the medical records of over 400,000 Medicare patients aged 65 and older, researchers at Vanderbilt University Medical Center found that Z-drugs are nearly as risky as benzodiazepines. Patients using benzodiazepines and opioids had a 221% higher risk of death from any cause, while those taking z-drugs and opioids had a 68% increased risk of dying.

Benzodiazepines such as Xanax and Valium are primarily used to treat anxiety. Until recently, benzodiazepines were often co-prescribed with opioids to pain patients, a practice that is now discouraged because both drugs suppress respiration, which can lead to an overdose.

"Our findings indicate that the risks of benzodiazepine-opioid use go well beyond the recognized hazards of overdose. They also suggest that the z-drugs, thought to have better safety than the benzodiazepines, in fact are dangerous when prescribed in combination with opioid pain medications," said Wayne Ray, PhD, professor of Health Policy at Vanderbilt and lead author of the study published in PLOS Medicine.

"Our findings add urgency to efforts to limit concurrent prescribing of benzodiazepines and opioids. They also suggest that targeted warnings are needed to advise older patients and their providers regarding the potential risks of taking z-drugs with opioids."

Last year the Food and Drug Administration ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and overdose, particularly when the drugs are used with opioids or alcohol.   

In 2019, the FDA also ordered stronger warning labels for Z-drugs, but in that case it was to caution people about rare side effects such as sleepwalking, sleep driving and other risky behaviors.  

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.

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

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

“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.