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

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.

Diet Changes Reduce Migraine Headaches

By Pat Anson, PNN Editor

There are many new treatments available for migraine sufferers; everything from CGRP inhibitors to neuromodulation to green light therapy. But there may be a simpler and less expensive way to reduce the frequency and severity of migraine headaches: changing your diet.

A new study funded by the National Institutes of Health found that migraine sufferers who ate more fatty fish and reduced their consumption of polyunsaturated vegetable oils had fewer headaches.

The findings are similar to another recent study that found foods containing healthy omega-3 fats – such as fish, flaxseed and walnuts – can reduce inflammation and neuropathic pain. Researchers say the two studies suggest that dietary changes can affect pain levels for other types of chronic pain.  

“It may ultimately be possible to integrate targeted dietary changes alongside medications to improve the lives of patients with chronic pain,” said Chris Ramsden, MD, a clinical investigator and adjunct faculty member at the University of North Carolina at Chapel Hill.

“Biochemical findings from both studies support the biological plausibility for this type of approach and could open the door to new approaches for managing many types of chronic pain. What is needed now is more evidence from randomized controlled trials in other populations with chronic pain.”

Ramsden is lead author of a study, published in the British Medical Journal, in which 182 adults with frequent migraines were broken into three groups and put on special diets for 16 weeks.

One group received meals that had high levels of fatty fish and low amounts of linoleic acid, a polyunsaturated fatty acid commonly found in American diets of corn, soybean and other vegetable oils. A second group received meals that had high levels of fatty fish and higher linoleic acid. The third control group received meals with high linoleic acid and low levels of fatty fish to mimic what an average American consumes.

"Our ancestors ate very different amounts and types of fats compared to our modern diets," said co-first author Daisy Zamora, PhD, an assistant psychiatry professor in the UNC School of Medicine. "Polyunsaturated fatty acids, which our bodies do not produce, have increased substantially in our diet due to the addition of oils such as corn, soybean and cottonseed to many processed foods like chips, crackers and granola."

When the study began, participants averaged over 16 headache days per month and over five hours of migraine pain each headache day -- despite taking multiple headache medications.

Those who consumed a diet low in vegetable oil and high in fatty fish had 30% to 40% reductions in total headache hours per day, severe headache hours per day, and overall headache days per month compared to the control group.

Blood samples from this group also had lower levels of pain-related omega-6 fatty acids found in processed foods.

“The effect we saw for the reduction of headaches is similar to what we see with some medications.”

— Daisy Zamora, PhD, UNC School of Medicine

“Our trial is the first moderate sized controlled trial showing that targeted changes in diet can decrease physical pain in humans,” Ramsden told PNN, noting that fatty acids appear to regulate the production of calcitonin gene-related peptides, the same protein targeted by CGRP medications.

“Diets alter the amounts of omega-3 and omega-6 fatty acids in the nervous system and other tissues linked to chronic pain. These fatty acids are converted by the body into biochemical mediators of pain. Several of these biochemical mediators act on receptor channels to regulate CGRP release,” he said in an email.

"I think this modification in diet could be impactful," Zamora added. "The effect we saw for the reduction of headaches is similar to what we see with some medications.”

Zamora, Ramsden and their colleagues are currently working on a new study to test diet modification for other chronic pain syndromes.

Most Sickle Cell Patients Face Stigma During ER Visits

By Pat Anson, PNN Editor

Nearly two-thirds of people with sickle cell disease in the U.S. feel judged and stigmatized when they visit an emergency department due to a pain flare, according to a new survey by Health Union.

About 100,000 Americans live with sickle cell disease (SCD), a genetic disorder that mainly affects people of African or Hispanic descent. SCD causes red blood cells to form in a crescent or sickle shape, which can create blockages in blood vessels that cause intense pain.  It’s not uncommon for someone with SCD to visit an ER a few times each year due to pain or complications such as anemia, stroke, infection and organ failure.

Health Union surveyed 111 people living with SCD to share their experiences dealing with the disease and how they are perceived by healthcare professionals, coworkers, teachers, friends and family members. Most said they did not feel judged or stigmatized by others – except when dealing with ER staff.

Many felt ER staff were rude, ignorant or misinformed about sickle cell disease, didn’t take their pain seriously, and believed they were drug seekers. Nearly half of those surveyed (43%) said they avoided going to the ER because they worried that people would judge them.

“A doctor judged me during a hospitalization. He stated I wasn’t in that much pain to be using Dilaudid. He also stated I was drug seeking because a sickle cell crisis can be managed with Motrin. His statement is not true!” one participant told Health Union.

Sickle cell patients had an entirely different take on their pharmacists, hematologists and primary care providers. Over half (53%) trusted their providers and felt their primary care doctors were friendly, understanding, easy to talk to, and provided excellent care.

"Navigating the healthcare system can already be complex, but undergoing such wildly different experiences can make access to reliable, timely, effective care even more difficult for people with sickle cell disease," said Olivier Chateau, Health Union's co-founder and CEO.

The finding that many people are not happy with their pain treatment in hospitals is not unique to sickle cell patients.  A 2016 PNN survey of over 1,250 hospitalized pain patients found that most felt they were labeled as addicts or drug seekers. Over 80% believed hospital staff were not adequately trained in pain management and over half rated the quality of pain care in hospitals as poor or very poor.  

A report last year by the National Academies of Sciences, Engineering, and Medicine found that sickle cell patients often face discrimination and stigma when navigating the healthcare system. The report found that SCD received little attention from the healthcare community compared to other chronic illnesses. To get proper treatment, many sickle cell patients have to educate themselves about their disease and become their own advocates.

The Health Union survey found that nearly three out of four sickle cell patients (73%) were currently using a prescription analgesic. Many others took prescription strength NSAIDs (35%), muscle relaxants (23%) or anti-anxiety/antidepressant drugs (16%). Only 5% said they experienced an issue with substance abuse.

Finding Inner Peace and Justice

By Mia Maysack, PNN Columnist

The vast majority of people who live with chronic pain and illness are blameless. It’s not our fault that we’re sick.  

I, for example, was a kid when an ear infection that led to a lifelong traumatic brain injury.  An innocent student and young career person who constantly missed class and work because of chronic migraines. Lack of proper care only further complicated matters.  

My health conditions were my biggest bullies; repeatedly huffing, puffing and blowing down any chance I had for normalcy or life without them. I often felt as though I were a prisoner within my own body. There were moments that I almost didn't make it through.

I'd be lying if I didn't confide some days still push me to my limits. But I’ve learned to pace myself and honor my capabilities one breath at a time.

Ask yourself this question: If you had to name all the things in life that you love, how long would it take for you to name yourself?  

Learning self-love is probably one of the biggest aspects of my self-care plan. But even deeper than self-love is a new concept I am exploring, called Inner Justice. 

When I feel well enough, I participate in a local campaign I began called “Honk4Justice.” A sign is held at busy intersections, inviting drivers to participate in the civil rights movement by simply honking. 

Often the question is asked:  "Justice for who?"

There are many answers.  Justice is waiting for proper verdicts and sentencing for killers. Justice is the same treatment for others that I'd hope to receive for myself. Justice is an equal amount of justice from one person to the next. Justice for the inner climate that makes up our individual perceptions of reality. 

Something that became very apparent early on in my journey with medical justice is that all pain and all hurt matters. Each of us, as part of this human experience, suffer somehow. Something has tested, caused inconvenience, broken our hearts or inflicted trauma in our lives.   

Instead of fixating on what separates us, we should focus on the commonalities to be found in the human experience. That includes physical and emotional pain. 

Whether it’s enduring systemic oppression or maltreatment, everything in existence is valid, causes a ripple effect and is connected. This means any one of us is only as strong as the weakest. That is why addressing our own personal judgement, ego, issues, privilege and wounds is paramount to move forward with individual healing and wellness.  

The beginning of this process for me meant developing a two-way relationship with my symptoms. I learned to approach myself as I would a dear friend, because ultimately the longest standing fellowship we’ll ever have is with ourselves. I've learned to navigate uncertainty, embrace the grand master plan, and surrender to the present as it comes. 

Living with a traumatized nervous system that constantly feels threatened and cultivating a sense of safety can seem like an impossible task, but it provides an opportunity for self-compassion. Once we’ve internalized that,  it becomes an available source of energy to pull from for understanding, accepting and having empathy for others. 

For as many more days as we have left, let us be open to learn, listen, teach and try for ourselves, each other and all those still to come.

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

Fibromyalgia Patients Substituting CBD for Pain Medication

By Pat Anson, PNN Editor

With opioid medication increasingly harder to obtain, many people with chronic pain are turning to cannabis-based products for pain relief.  A new survey of fibromyalgia patients suggests that cannabidiol (CBD) works well not only as an alternative to opioids, but for many other pain medications.

Researchers at Michigan Medicine surveyed 878 people with fibromyalgia who were currently using a CBD product and found that 72% of them had substituted CBD for a conventional pain medication.

Over half (59%) reduced or stopped taking non-steroidal anti-inflammatory drugs (NSAIDs), while 53% used CBD as a substitute for opioids, gabapentinoids (35%) or benzodiazepines (23%), an anti-anxiety medication that was once commonly prescribed for pain.

"I was not expecting that level of substitution," said Kevin Boehnke, PhD, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at Michigan Medicine.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia such as gabapentinoids often prove to be ineffective or have unwelcome side effects.

"Fibromyalgia is not easy to treat, often involving several medications with significant side effects and modest benefits," said Boehnke. "Further, many alternative therapies, like acupuncture and massage, are not covered by insurance."

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana.  Some cannabis products contain a combination of THC and CBD, while others just have CBD.

Survey participants who used CBD products containing THC were more likely to report symptom relief and to use them as substitutes for pain medication. This suggests that THC may enhance the therapeutic benefits of CBD.

A recent Israeli study found that people with fibromyalgia who took daily doses of cannabis oil rich in THC had significantly less pain and fatigue.

Another recent study in Israel found that cannabis products – both with and without THC – reduced pain and depression in fibromyalgia patients. Like the findings of the Michigan study, about one out of five patients either stopped taking or reduced their use of opioids and benzodiazepines.

"People are using CBD, substituting it for medication and doing so saying it’s less harmful and more effective,” said Boehnke. “If people can find the same relief without THC's side effects, CBD may represent a useful as a harm reduction strategy."

The Michigan Medicine study was recently published in The Journal of Pain.

Can a Low-Fat Diet Reverse Neuropathic Pain?

By Pat Anson, PNN Editor

Low fat diets are often recommended for people suffering from obesity and cardiovascular disease, but changes in eating habits are rarely recommended for people who live with chronic pain.

That could be changing thanks to a new study by researchers at the University of Texas Health Science Center, who found that diets high in omega-6 fats are strongly associated with inflammation and neuropathic pain. Omega-6 fats are widely found in typical Western diets of fast food, processed snacks, cakes, and fatty or cured meats.

Conversely, researchers say foods containing healthy omega-3 fatty acids – such as fish, flaxseed and walnuts – could reduce or even reverse neuropathic pain associated with diabetes. Their findings were recently published in the journal Nature Metabolism.

Diabetic neuropathy is a progressive and painful disease that causes burning or stinging sensations in the hands and feet. Many drugs used to treat neuropathic pain, such as gabapentin and pregabalin, often don’t work or have unpleasant side effects.

“This paper is a high-profile contribution for a huge unmet translational need as there are no treatments altering the nature of this neurological disease,” said José Cavazos, MD, director of the South Texas Medical Scientist Training Program at UT Health San Antonio.

In experiments on humans and laboratory animals, UT researchers found that mice fed a diet high in omega-6 polyunsaturated fats became hypersensitive to pain, cold and heat stimulation – signs of peripheral nerve damage. Lowering the amount of omega-6 fats and increasing omega-3 fatty acids reduced pain sensitivity in the mice.

The researchers also found that high levels of omega-6 lipids in the skin of patients with Type 2 diabetes were strongly associated with neuropathic pain and the need for analgesic drugs.

“We believe that these data warrant continued investigation of peripheral fatty acid and metabolite levels as potential pain biomarkers. Such biomarkers could provide clinicians with reliable objective endpoints to guide diagnoses as well as decision making on treatment regimens, including therapeutic diets,” wrote lead author Jacob Boyd, MD, UT Health San Antonio.

About 34 million people in the U.S. have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.

A 2015 study found that a vegetarian diet coupled with vitamin B12 supplements significantly reduced pain and improved the quality of life of people with diabetic neuropathy. Participants also had lower blood pressure and cholesterol levels, and lost an average of 14 pounds.

Tiny Electrode Could Expand Use of Spinal Cord Stimulators

By Pat Anson, PNN Editor

A tiny inflatable device – about the width of a human hair – could make spinal cord stimulation less invasive and more practical for millions of people who suffer from chronic back or leg pain, according to researchers at the University of Cambridge.

Long considered the treatment of last resort, spinal cord stimulators (SCSs) are bulky devices implanted along the spine that use electrode wires connected to a battery to emit electric currents that block pain signals from reaching the brain. About 50,000 stimulators are surgically implanted every year, but many wind up being removed due to complications from surgery or because they are ineffective.

“Our goal was to make something that’s the best of both worlds – a device that’s clinically effective but that doesn’t require complex and risky surgery,” said Christopher Proctor, PhD, a research fellow at Cambridge’s Department of Engineering and one of the senior authors of a study published in Science Advances. “This could help bring this life-changing treatment option to many more people.”

Proctor and his colleagues developed a miniaturized electrode that is so small it can be rolled up into a tiny cylinder, inserted into a needle, and implanted into the epidural space of the spinal column.

As the video below shows, the device can then be inflated with water or air so that it unrolls like a tiny air mattress and covers part of the spine. When connected to a battery, the ultra-thin electrode can send small electric currents to the spinal cord, just like a traditional stimulator.

“In order to end up with something that can be implanted with a needle, we needed to make the device as thin as possible,” said co-author Ben Woodington, a PhD candidate in Cambridge’s Department of Engineering.

Researchers made the device with flexible electronics used in the semiconductor industry; tiny fluidic channels used in drug delivery; and shape-changing materials used in robotics.

“Thin-film electronics aren’t new, but incorporating fluid chambers is what makes our device unique – this allows it to be inflated into a paddle-type shape once it is inside the patient,” said Proctor.  

Early versions of the device were so thin they were invisible to x-rays, which surgeons would need to confirm the device was in the right place before inflating it. Researchers added some bismuth particles to make the device visible without increasing the thickness too much.

The experimental device has only been tested in human cadavers. More extensive testing and clinical trials will be required before the device can be used on patients – possibly in two or three years. The Cambridge research team is currently working with a manufacturer to further develop and improve the device.

“The way we make the device means that we can also incorporate additional components – we could add more electrodes or make it bigger in order to cover larger areas of the spine with increased accuracy,” said senior co-author Damiano Barone, MD, a clinical lecturer in Cambridge’s Department of Clinical Neurosciences.

“This adaptability could make our SCS device a potential treatment for paralysis following spinal cord injury or stroke or movement disorders such as Parkinson’s disease. An effective device that doesn’t require invasive surgery could bring relief to so many people.”

“This technology has the potential to transform clinical treatment, significantly improve pain management for so many people, and reach patients who cannot be treated with existing devices,” said Rachel Atfield, PhD, Commercialisation Manager at Cambridge Enterprise, which has patented the device.

A 2018 study by a team of investigative journalists found that spinal cord stimulators have some of the worst safety records of medical devices tracked by the U.S. Food and Drug Administration. A review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

OHSU Researchers Find ‘No Evidence’ to Support Use of Kratom

By Pat Anson, PNN Editor

A federally funded review of plant-based treatments for chronic pain has yet to find adequate clinical evidence on the benefits or harms of kratom, an herbal supplement used by millions of Americans to relieve pain, anxiety, depression and other medical conditions.

In an update released this week, researchers at Oregon Health & Science University (OHSU) reported that some cannabis products provide small to moderate pain relief, a finding based on a systematic review of two dozen clinical trials of cannabis.  But no similar studies were found to support the use of kratom or any other plant.   

“No evidence on other plant-based compounds, such as kratom, met criteria for this review,” researchers said.

OHSU was awarded a contract last year by the Agency for Healthcare Research and Quality (AHRQ) to review the evidence for cannabis, kratom and other plant based treatments for chronic pain.  

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia. Although it has been used for centuries as a natural stimulant and pain reliever, few clinical trials have been conducted to test kratom’s efficacy or safety. The few studies that have been conducted were excluded by OHSU researchers due to their size, methodology or because they weren’t published in English.

For example, a 2020 Malaysian study that found kratom provided “a substantial and statistically significant increase in pain tolerance” was excluded because the young men who participated in the one-day trial were considered an “ineligible population.” OHSU researchers excluded all studies lasting less than 4 weeks.

“The conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd.”

— Mac Haddow, American Kratom Association

“Setting aside the disappointment that AHRQ does not appear to be taking the purpose of the review of plant-based compounds very seriously, the conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd,” said Mac Haddow, a lobbyist for the American Kratom Association.  “It’s like denying that Chicago is a windy city because the instrument that was selected for assessing wind speed was not used.”

Haddow said the AHRQ review should be expanded to include survey results from kratom users, animal studies and other types of research that don’t rise to the level of a clinical trial.

“The review appears to be excluding any research that is not a pharmaceutical development clinical trial model that would involve controlled kratom administration in a full-blown human clinical trial,” Haddow told PNN. “The deeply embedded bias against plant-based compounds that offer potential values for addressing the opioid crisis — or even providing a non-addictive and safer alternative for the management of acute and chronic pain should be a priority for the AHRQ.”

This isn’t the first time the quality of federal research into the safety and efficacy of kratom has been questioned. In 2018, the Department of Health & Human Services quietly withdrew an FDA request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. A former HHS official recently said the FDA’s recommendation was rejected because of “embarrassingly poor evidence & data.”

$2 Billion in Federal Grants

A final report on plant-based treatments for chronic pain is expected in August. As PNN has reported, OHSU researchers have recently conducted a series of reviews on a wide variety of pain therapies for the AHRQ, which are being used by the Centers for Disease Control and Prevention to revise and possible expand its controversial 2016 opioid guideline.   

Much of that research is being led by Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the use of opioid medication.

The contract on plant-based pain treatments is potentially worth up to $1.4 million for OHSU, a public research university that the federal government often turns to for medical research. According to the website GovTribe, in the last five years OHSU has been awarded nearly $2 billion in federal research grants to study everything from cancer and contraceptives to Alzheimer’s and Parkinson’s Disease.

OHSU paid $1.3 million back to the government to settle allegations that it misused grant money in its primate research center. Although the settlement was reached in 2018, it was not made public until recently in an Inspector General’s report, according the animal rights group Rise for Animals.

Does Cannabis Increase Risk of Suicide?

By Roger Chriss, PNN Columnist

A new National Institute of Health study confirms a long-standing association between cannabis use and suicidality in younger adults.

NIH researchers looked at data from over 280,000 people aged 18 to 34 who participated in the National Survey of Drug Use and Health from 2008 to 2019. Their findings, published in JAMA Open Network, concluded that cannabis increased the risk of suicidal thoughts (ideation), planning and attempts by young adults.

“While we cannot establish that cannabis use caused the increased suicidality we observed in this study, these associations warrant further research, especially given the great burden of suicide on young adults,” Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a statement.

Cannabis use is rising fast in the United States. Use more than doubled from 22 million people in 2008 to 45 million in 2019, and regular use tripled to nearly 10 million people by the end of the study. The increased use of cannabis coincided with a spike in suicides among young adults, which rose by 52% for women and 45% for men from 2008 to 2019.

NIH researchers found that daily cannabis use and a history of a major depressive episode (MDE) increased the risk of suicide, particularly for women. The prevalence of a suicide plan in the past year was 52% higher for women with MDE than for men with MDE.

But even when a young adult was not depressed, suicide ideation rose in tandem with the frequency of their cannabis use. Seven percent of those who used cannabis occasionally had suicidal thoughts, a number that rose to 9% for people who use cannabis daily and to 14% for people with cannabis use disorder.

The NIH study supports prior findings. Stanford researchers recently reported that in states that legalized recreational marijuana there was a 46% increase in self-harm injuries among 21- to 39-year-old men.

A 2020 study in the Journal of Addiction Nursing and a 2019 study in JAMA Psychiatry also found a strong association between cannabis and suicidality.

But the relationship is complex. The 2020 study looked at recreational cannabis use, while the 2019 study examined adolescent use. The new NIH study looked at national survey data over a period that started well before adult-use legalization in Colorado and Washington. It makes no distinction between medical and recreational cannabis, a distinction that could be important.

Explanations for the suicide association also vary, such as the higher potency of cannabis and increased availability of cannabis products. But these trends vary by state and over time, so more granular analysis is needed in order to tease out relationships among these factors.

More important, it is not clear at this point if cannabis use is simply associated with an underlying trend, exacerbating a growing problem, or is itself an independent risk factor. Sorting this out will be extremely difficult, because cannabis use does not occur in a vacuum and cannabis itself is a delivery system for a slew of cannabinoids whose effects and interactions are not fully understood.

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. 

Have You Been Labeled a 'Difficult' Patient?

By Ann Marie Gaudon, PNN Columnist  

We’re all aware of doctors labeling a patient as “difficult” or some other derogatory term. There are even entire categories set up for these “heartsink” patients, who behave in ways that doctors consider dependent, entitled, manipulative or even self-destructive.

Imagine if doctors moved the conversation away from “difficult patient” to “difficult doctor-patient interactions” by taking a closer look at behaviour patterns that can occur in their relationships with patients.

Let’s start at the beginning – literally — by studying interactions between infants and their caregivers. “Attachment Theory” was first developed by the English psychologist, psychiatrist and psychoanalyst John Bowlby.  He proposed that infants have a biological drive to seek nurture and closeness to their primary caregivers. How the caregiver attunes to that baby will actually shape how the infant’s brain develops. Ultimately, our adult selves are influenced by these layers of memory and how we adapted to that care.

There are four main “Attachment Styles” seen in adults, according to Bowlby and psychologist Mary Ainsworth. How do these four styles play out in the doctor’s office? Do you see yourself in any of them?

1) Secure Patient

• Is often trusting, comfortable seeking help and values advice

• Doctor feels sympathetic to patient’s needs and confident that advice will be followed

• Successful outcomes are maximized with this relationship

2) Avoidant/Dismissive Patient

• Is often distant and does not trust the doctor; may miss appointments

• Displays a lack of engagement; may minimize symptoms and dismiss need for treatment

• Doctor may become frustrated with patient saying “I can’t” or “It’s not really that bad”

• May increasingly withdraw from care; denial of problems and emotions

• Patient may be in crisis when their hyper self-reliance strategy begins to fail

3) Ambivalent/Anxious Patient

• Has little trust in ability of self and others; expects rejection; can be highly emotionally reactive

• Doctor may feel confused by patient’s alternating avoiding and approaching; being unpredictable

• Doctor may get upset with inconsistency of behaviour, especially if patient pulls away when help is offered

• Patient anxiety increases, depression may also appear; may withdraw and miss appointments or leave in the middle of one

4) Disorganized Patient

• Little trust in others; cognitive ability becomes disorganized when stressed

• May be fearful of doctor and treatment; may be triggered by earlier traumas

• Doctor may become fearful for patient and inability to contain patient’s overwhelming emotions

• Doctor may feel like a failure and try harder

• Overwhelming complexity of patient’s problems can fragment clinical teams

• Patient and doctor may reinforce feelings of being overwhelmed and loss of control of the situation

• Care may be chaotic, ineffective; mental health crisis may prevail

If physicians were familiar with Attachment Theory and the style for each patient, they could tailor their approach to best serve the patient. Predicting and planning for possible poor outcomes could benefit with a reduction in negative experiences for both patient and physician.

Shifting away from “difficult patient” attitudes and pejoratives toward “Attachment-Based Care” would be a shift away from what is unproductive and a move toward helpful and effective treatment approaches.

Patients with an Avoidant Attachment Style could be provided a predictable treatment framework (no surprises) and information that is clear and not emotionally challenging. These patients can help themselves by being honest with the physician if they are not happy with their care. Keeping a journal and using internet-based telehealth may also be beneficial for the patient to use.

Patients with an Ambivalent/Anxious Attachment Style could be encouraged to build self-confidence to increase their ability to tolerate anxiety and uncertainty. Scheduling regular appointments to avoid the patient feeling it is necessary to magnify symptoms to receive care is another strategy. Being consistent and clear will also help to decrease anxiety. If these patients can learn to regulate their emotions, this will go a very long way in clinical interaction benefits. Regular exercise and mindfulness techniques will also help. A therapist will almost certainly be required.

A physician being aware that patients with a Disorganized Attachment Style are often inconsistent in attending appointments and show ambivalence in decision-making will allow the professional to plan ahead and pull in a support person if they feel overwhelmed. The seriousness of this patient in a stressed state must be understood and supported, as anger and decompensation are common. For this patient, a patient advocate may be very beneficial as well as a management plan that all can collaborate on.

Attachment Styles are influential in all areas of life and important determinants of therapeutic interactions and relationships. Using an Attachment-Based Care approach would provide a framework to understand these interactions and how best to serve the needs of patients.

In an ideal world, all non-securely attached patients as well as non-securely attached physicians would explore their maladaptive strategies with a trained therapist to help move them toward a Secure Attachment Style that has less suffering and psychologically flexible strategies for living. Until that time, let’s stop the name-calling and work toward compassionate care for all patients.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

Cutting My Opioid Dose in Half Left Me in Unbearable Pain

By Virginia Brandford, Guest Columnist

Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dose your body has become dependent on.

Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with alkaptonuria (AKU) to prevent chronic joint pain and inflammation.

AKU is known as “Black Bone Disease” because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in Egyptian mummies. Watch this video if you want to learn more about my disease.  

After being diagnosed with AKU, I was placed on a very high dose of morphine to stop my body from producing Homogentisic Acid (HGA). People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA.

When it accumulates at high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them.

My longtime physician identified morphine as a pain medication that helped, without causing side effects. I was able to function again and live a decent life, in spite of having such a debilitating disease.

Virginia Brandford

But in 2017, many of the recommendations in the CDC opioid guideline were adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a new doctor willing to prescribe the same dose of morphine. They all see my need for opioids, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me!

Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also accumulated in my spine, liver and kidneys.

I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids.

I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive.

Legitimate pain patients like me who never abused drugs are being treated like addicts and demonized for taking prescribed medicines from licensed doctors.

Please help me obtain the help I need before this disease spreads even more. I am totally bedridden and need help. I pray that a revision of the CDC opioid guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity.

Virginia Brandford lives in Hawaii. PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Experimental Brain Implant Automatically Relieves Pain

By Pat Anson, PNN Editor

An experimental brain implant that automatically detects and relieves pain in laboratory animals has the potential to be adapted for human use, according to researchers at NYU Grossman School of Medicine. The computerized device is the first of its kind to target both acute and chronic pain, and may also be effective in treating anxiety, depression, panic attacks and other brain-based disorders.

“Our findings show that this implant offers an effective strategy for pain therapy, even in cases where symptoms are traditionally difficult to pinpoint or manage,” said senior author Jing Wang, MD, an Associate Professor of Anesthesiology at NYU Langone Health.

The technology, known as a closed-loop brain-machine interface, detects brain activity in the anterior cingulate cortex, a region of the brain that is critical for pain processing. A computer linked to the device identifies pain signals in real-time, triggering a therapeutic stimulation of another region of the brain, the prefrontal cortex, to ease pain sensations.  

Wang and his colleagues installed the tiny electrodes in the brains of dozens of rats and then exposed them to carefully measured amounts of pain. The animals were closely monitored to see how quickly they moved away from a source of acute pain.

The study findings, published in the journal Nature Biomedical Engineering, showed that rats withdrew their paws 40 percent more slowly from the pain source when the device was turn on. In addition, animals in acute or chronic pain spent about two-thirds more time in a chamber where the device was turned on than in another chamber where it was not.

Researchers say the implant accurately detected pain up to 80 percent of the time. Since the device is only activated in the presence of pain, it lessens the risk of overuse, tolerance and addiction.

“Our results demonstrate that this device may help researchers better understand how pain works in the brain,” says lead investigator Qiaosheng Zhang, PhD, a doctoral fellow in the Department of Anesthesiology, Perioperative Care and Pain at NYU Langone. “Moreover, it may allow us to find non-drug therapies for other neuropsychiatric disorders, such as anxiety, depression, and post-traumatic stress.”

Zhang says the implant’s pain-detection properties could be improved by installing electrodes in other regions of the brain besides the anterior cingulate cortex. He cautions, however, that the technology is not yet suitable for use in people. Researchers are investigating whether less-invasive forms of the implant can be adapted for human use.

Brain implants – also known as deep brain stimulators -- are currently used to prevent seizures and tremors in people with Parkinson’s disease and epilepsy.

Follow Treatment Guidelines for Low Back Pain and Get Back to Work Sooner

By Pat Anson, PNN Editor

Employees with acute low back pain miss fewer days of work if they exercise, take over-the-counter pain relievers and are not prescribed opioid medication, according to a large new study of worker compensation claims in California.

"The closer people's care follows evidence-based guidelines, the faster their back pain resolves, by quite a bit," said Kurt Hegmann, MD, director of the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

Hegmann and his colleagues analyzed insurance data for nearly 60,000 people with low back pain from 2009 to 2018, comparing their treatment to guidelines created by the American College of Occupational and Environmental Medicine. Those guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and physical therapy for low back pain, while frowning on the use of opioids or invasive procedures such as spinal injections.

The research findings, recently published in PLOS ONE, showed that people who didn’t follow treatment guidelines missed an average of 11 more days of work each year compared to those who only had recommended treatments.

Opioids were once commonly prescribed for low back pain, a practice that has fallen out of favor due to fears of addiction and overdose. In the nine years of the study, researchers found that opioid prescribing for low back pain declined by 86 percent, fueled in part by insurers who were unwilling to pay for the drugs.

"The reduction in opioids prescription is particularly impressive," Hegmann said. "In this case, the insurer is likely to not pay for opioids even if they are prescribed. It suggests what's possible when the 'carrot' of good health care is missed and instead the 'stick' of compliance with a guideline is in place."

Nearly two-thirds of the people included in the study received at least one non-recommended treatment, although adherence to treatment guidelines improved over time. In 2009, 10% were treated according to guidelines, but that rose to 18% by 2018.

Low back pain is the world’s leading cause of disability. It mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

Treatment guidelines for low back pain have changed considerably in the last 20 years. At one time, bed rest was commonly recommended, a treatment now seen as counterproductive. Moderate exercise and physical activity help people return to work sooner.

"Being out of work impacts many facets of your life," said first author Fraser Gaspar, PhD. "In addition to the physical disability that's causing the person to miss work, the worker is making less money, while they often incur additional costs and experience mental strain. Getting people back to their normal lives is really important, and our research shows that following guidelines makes that happen faster."

Researchers Warn of Deadly New Illicit Opioid

By Pat Anson, PNN Editor

A new illicit opioid that is 20 times more potent than fentanyl has been linked to at least eight fatal overdoses in the U.S. in the last month, according to a public safety alert released by a Pennsylvania research laboratory.

The Center for Forensic Science Research & Education (CFSRE) said its scientists detected N-pyrrolidino etonitazene -- also known as etonitazepyne -- in eight blood samples taken during recent death investigations in West Virginia, Pennsylvania, New York, Florida and Colorado.  Four of the deaths occurred in West Virginia.

“The toxicity of N-pyrrolidino etonitazene has not been examined or reported but recent association with death among people who use drugs leads professionals to believe this synthetic opioid retains the potential to cause widespread harm and is of public health concern. Identifications of N-pyrrolidino etonitazene have also been reported recently from agencies in Europe,” the safety alert said.

Etonitazepyne is a synthetic opioid that is chemically similar to etonitazene, another powerful narcotic that started appearing in illicit drug markets and counterfeit pills in the U.S. and Canada last year.  While etonitazene is classified as an illegal Schedule I controlled substance by the DEA, etonitazepyne has not specifically been scheduled. Several websites even list it for sale for “chemical research.”

"The current drug landscape in the United States is unstable and unpredictable – especially the opioid market – which can ultimately lead to deadly outcomes," said Dr. Alex Krotulski, an associate director at CFSRE. "The purpose of this public alert is to raise awareness about a new and already deadly synthetic opioid so that way people who use drugs are able to modify use patterns and so that laboratories know to test for this new drug in their states or jurisdictions.”

Etonitazepyne may be new to law enforcement, coroners and public health officials, but illicit drug users have been warning each other about the drug for several months in online message boards.

“I got a report about an overdose with only 1 MG of Etonitazepyne (snorted) that caused a pretty high tolerance user to become unconscious and stopped breathing, and he had to be rescued from paramedics,” a poster said on Reddit.

“Everyone needs to be careful with this one. It's not for anyone who has no tolerance to opioids, and can still be dangerous for those who do,” another poster wrote.