Headache on the Hill: How Advocacy Empowers Patients

By Mia Maysack, PNN Columnist

Headache on the Hill is an annual lobbying event for migraine and cluster headache patients and advocates that takes place in Washington, D.C. I was fortunate to participate this past week and for the last three years, and look forward to participating in as many more as I am able.  

Headache on the Hill (HOH) is organized by the Alliance for Headache Disorders Advocacy and there are multiple other coalitions, organizations, foundations and institutions that make up the partnering network. 

Hundreds of patients, caregivers and medical professionals join forces in venturing to the Hill together, visiting congressional offices (there were 250 meetings this year, the most ever!) to present ever changing “asks” for more research and funding.

My first year at HOH was surreal. I hadn't realized exactly what I'd gotten myself into or the extent it would alter the course of my life. I found a great deal of comfort, as well as empowerment, from the realization that our legislators are much like doctors in the sense that they essentially work for us and we're supposed to be a team.  

The second time around, I shifted my approach from requesting everything right off the bat to inquiring about their knowledge: “Do you or does anyone you know live with headache or migraine?"

Many do have a connection, which isn't surprising, given there are 47 million Americans living with migraines and cluster headaches.  Bonding over facts is a great way to raise awareness and build rapport.  

They say the third time is a charm and, in this instance, I’d have to agree. Not only have I become stronger and more affirmed in using my voice, but one could even say I've grown darn right ballsy!

My two-decade old traumatic brain injury has hurt every day since it happened, so that along with the fact I know I'm not alone in this experience, is what leads me back to these gatherings.

Our agenda was to address the emergent shortage of specialists and astronomical need for more pain management education prior to a provider going into practice. 

As of now, the United States has less than one-sixth the number of headache doctors it needs.  There are 1.2 physicians per 100,000 people with migraine. And by 2032, we’ll be facing a shortage of up to 122,000 doctors and specialists.

As with other chronic pain conditions, when acute migraine and headache attacks are not treated properly or go untreated, they can become chronic and symptoms worsen. Improper pain management can lead to an understandable feeling of desperation, which could play out as people attempt to self-medicate. That has potential to land us in the exact sort of drug crises we’re facing right now.      

We know migraine is the second leading cause of global disability (behind low back pain), yet it has received little funding.  According to the World Health Organization, migraine results in more lost years of healthy life in the U.S. than epilepsy, multiple sclerosis (MS), tuberculosis and ovarian cancer combined.  

Head-related pain often doesn’t respond well to opioid medication, but despite the risk of complications, opioids are still being used, primarily in emergency room scenarios. 

In a more general sense, 50 million Americans have chronic pain, of which 20 million, myself included, experience “high impact” chronic pain. I don't know about you, but the fact so many of us are living without an adequate care plan or any relief whatsoever, is about as crucial as it gets. Hence the importance of showing up at HOH to demonstrate our commitment and the seriousness pertaining to these issues.   

The travel, excitement, boat load of walking, and emotional components take a very real toll. It's not uncommon after trips like this that we all crash. Some require weeks to months just to get back to baseline, but what's most remarkable is that we continue to do it all over again. 

When navigating the maze of those congressional halls and seeing, supporting, encouraging and taking care of one another, it is times like those that build me up, give me strength and fuel my fire to continue on with the work long after we've left Washington. 

Being an advocate is no longer something I do -- it is a part of who I am. 

Mia Maysack lives with chronic migraine, cluster headaches 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.

Missouri Finds Managing Pain Without Opioids Isn’t Easy

By Lauren Weber, Kaiser Health News

Missouri began offering chiropractic care, acupuncture, physical therapy and cognitive-behavioral therapy for Medicaid patients in April, the latest state to try an alternative to opioids for those battling chronic pain.

Yet only about 500 of the state’s roughly 330,000 adult Medicaid users accessed the program through December, at a cost of $190,000, according to Josh Moore, the Missouri Medicaid pharmacy director. While the numbers may reflect an undercount because of lags in submitting claims, the jointly funded federal-state program known in the state as MO HealthNet is hitting just a fraction of possible patients so far.

Meanwhile, according to the state, opioids were still being doled out: 109,610 Missouri Medicaid patients of all age groups received opioid prescriptions last year.

The going has been slow, health experts said, because of a slew of barriers. Such treatments are more time-consuming and involved than simply getting a prescription.

A limited number of providers offer alternative treatment options, especially to Medicaid patients. And perhaps the biggest problem? These therapies don’t seem to work for everyone.

The slow rollout highlights the overall challenges in implementing programs aimed at righting the ship on opioid abuse in Missouri — and nationwide. To be sure, from 2012 to 2019, the number of Missouri Medicaid patients prescribed opioid drugs fell by more than a third — and the quantity of opioids dispensed by Medicaid dropped by more than half.

Still, overdoses linked to legal and illicit opioids killed an estimated 1,132 Missourians in 2018 and 46,802 Americans nationally, according to the latest data available. Progress to change that can be frustratingly slow.

“The opioids crisis we got into wasn’t born in a year,” Moore said. “To expect we’d get perfect results after a year would be incredibly optimistic.”

Despite limited data on the efficacy of alternative pain management plans, such efforts have become more accepted, especially following a summer report of pain management best practices from the U.S. Department of Health and Human Services. States such as Ohio and Oregon see them as one part of a menu of options aimed at curbing the opioid crisis.

St. Louis chiropractor Ross Mattox, an assistant professor at chiropractic school Logan University, sees both uninsured patients and those on Medicaid at the CareSTL clinic. He cheered Missouri’s decision to expand access, despite how long it took to get here.

“One of the most common things I heard from providers,” he said, “is ‘I want to send my patient to a chiropractor, but they don’t have the insurance. I don’t want to prescribe an opioid — I’d rather go a more conservative route — but that’s the only option I have.’”

And that can lead to the same tragic story: Someone gets addicted to opioids, runs out of a prescription and turns to the street before becoming another sad statistic.

“It all starts quite simply with back pain,” Mattox said.

Practical Barriers

While Missouri health care providers now have another tool besides prescribing opioids to patients with Medicaid, the multistep approaches required by alternative treatments create many more hoops than a pharmacy visit.

The physicians who recommend such treatments must support the option, and patients must agree. Then the patient must be able to find a provider who accepts Medicaid, get to the provider’s office even if far away and then undergo multiple, time-consuming therapies.

The effort and cost that go into coordinating a care plan with multiple alternative pain therapies is another barrier.

“Covering a course of cheap opioid pills is different than trying to create a multidisciplinary individualized plan that may or may not work,” said Leo Beletsky, a professor of law and health sciences at Northeastern University in Boston, noting that the scientific evidence of the efficacy of such treatments is mixed.

And then there’s the reimbursement issue for the providers. Corry Meyers, an acupuncturist in suburban St. Louis, does not accept insurance in his practice. But he said other acupuncturists in Missouri debate whether to take advantage of the new Medicaid program, concerned the payment rates to providers will be too low to be worthwhile.

“It runs the gamut, as everyone agrees that these patients need it,” Meyers stressed. But he said many acupuncturists wonder: “Am I going to be able to stay open if I take Medicaid?”

Structural Issues 

While helpful, plans like Missouri’s don’t address the structural problems at the root of the opioid crisis, Beletsky said.

“Opioid overutilization or overprescribing is not just a crisis in and of itself; it’s a symptom of broader structural problems in the U.S. health care system,” he said. “Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments for which we’re not doing enough in terms of prevention and treatment.”

Fixing some of the core problems leading to opioid dependence — rural health care “deserts” and the impact of manual labor and obesity on chronic pain — requires much more than a treatment alternative, Beletsky said.

And no matter how many alternatives are offered, he said, opioids will remain a crucial medicine for some patients.

Furthermore, while alternative pain management therapies may lessen opioid prescriptions, they do not address exploding methamphetamine addiction or other addiction crises leading to overdoses nationwide — even as a flood of funds pours in from the national and state level to fight these crises.

“Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments.”

— Dr. Leo Beletsky, Northeastern University

The Show-Me State’s refusal to expand Medicaid coverage to more people under the Affordable Care Act also hampers overall progress, said Dr. Fred Rottnek, a family and addiction doctor who sits on the St. Louis Regional Health Commission as chair of the Provider Services Advisory Board.

“The problem is we relatively cover so few people in Missouri with Medicaid,” he said. “The denominator is so small that it doesn’t affect the numbers a whole lot.”

But providers like Mattox are happy that such alternative treatments are now an option, even if they’re available only for a limited audience.

He just wishes it had been done sooner.

“A lot of it has to do with politics and the slow gears of government,” he said. “Unfortunately, it’s taken people dying — it’s taken enough of a crisis for people to open their eyes and say, ‘Maybe there’s a better way to do this.’”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Feds Incinerate 28 Tons of Kratom

By Pat Anson, PNN

Over 28 tons of the herbal supplement kratom were recently destroyed by the federal government, the final chapter in a legal battle over one of the largest seizures of kratom in U.S. history.

The U.S. Marshals Office paid a hazardous waste company nearly $30,000 to transport the kratom from South Carolina to Florida, where it was incinerated at an energy-from-waste facility. The kratom had an estimated value of $1 million.

Kratom is a dietary supplement that millions of Americans use to self-treat their chronic pain, anxiety, depression and addiction.  It comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever.

The incinerated kratom was seized in 2018 after FDA inspectors found large quantities of kratom powder and capsules at a warehouse in Myrtle Beach, SC operated by Earth Kratom, a kratom wholesaler and vendor.

At the time, the federal government was engaged in a public relations campaign against kratom, led by then-FDA Commissioner Scott Gottlieb. Federal officials claimed kratom was a risky and addictive substance that should not be used to treat any medical condition.

“Serious concerns exist regarding the effect of kratom on multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom consumption has been linked to neurologic, analgesic and sedative effects, addiction, and hepatic toxicity,” U.S. Attorneys said in a civil forfeiture complaint that led to the kratom being seized.

Kratom can be sold legally in South Carolina and most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions.

“There’s nothing wrong with our facilities or our product,” explained Brian Stall, supervising manager for Earth Kratom. “We were selling a product for human consumption and they didn’t like that.”

Stall told PNN that Earth Kratom’s lawyers were able to persuade a judge to order the kratom returned, but it was seized a second time by U.S. Marshals. The kratom was wrapped in plastic and remained at Earth Kratom’s warehouse, but was off-limits to the company.

“They took all of our product and half of our building at that point,” said Stall. “It was a tough time for us. We’d worked really hard and really believed in the product. It really sucked.”

Earth Kratom’s entire inventory may have gone up in smoke, but it survived the ordeal and remains in business. It sells one of the most popular kratom brands, Trainwreck Kratom, a blend that combines several different kratom strains. PNN’s Crystal Lindell raved about Trainwreck as a pain reliever in a 2018 column.

Scott Gottlieb resigned as FDA commissioner in March 2019 and weeks later joined the board of directors at Pfizer. Although the FDA’s campaign against kratom seems to have quieted since Gottlieb’s departure, an import alert remains in effect that allows FDA inspectors to seize kratom products even “without physical examination.”    

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

American Agony: A New Book Exposes the War Against Pain Patients

By Pat Anson, PNN Editor

A provocative new book is shining a light on the opioid crisis in ways that may surprise you. In “American Agony: The Opioid War Against Patients in Pain,” author Helen Borel accuses government bureaucrats, law enforcement and the media of inciting opioid hysteria with a steady drumbeat of misinformation and propaganda about opioids – resulting in the needless suffering of millions of Americans and the deaths of thousands by suicide.   

“American pain patients are at risk of being underdosed, tapered without consent, and most horrible of all, cold-turkeyed. All without legal or medical protections to rescue them from the horrors of sudden withdrawal symptoms and cardiovascular and other complications leading to death arising out of this sudden disruption in their physiologic equilibrium,” Borel wrote.

“Further muddying the opioid hysteria waters are outright confabulations by the feds (HHS, CDC, DEA) who gossip about nonexistent drug abuse by patients on medically, ethically and legally prescribed opioid analgesics. And these same autocrats should feel guilty about the multitude of suicides their thoughtless actions have caused and are still causing. For shame!”

As a registered nurse, psychotherapist and medical writer, Borel was already familiar with important role of opioid medication, which she calls the “best treatment for most chronic pain.”

But her interest was piqued by reading Pain News Network and other online outlets, where she learned about the suffering and suicides of patients, the harassment and prosecution of doctors, and the disastrous impact of the 2016 CDC opioid guideline on American pain care.

“When I saw on Twitter the people talking about what was going on, I went to your website and other sites, and I saw all the information,” Borel told PNN.

“And I began to get angry that people were not being medicated. And I said to myself I’d like to bring all this information together in one place where everyone could access it.”

American Agony does just that. It’s a comprehensive examination of the opioid crisis, including a detailed look at its heroes and villains. There is no shortage of the latter, from the “haughty federal horde” that drew up the CDC guideline to the “American Nazis in full DEA regalia” who harassed doctors and lied to the press and public about opioid therapy.

Borel says the DEA should be dissolved, reorganized and rebranded as the Illicit Drug Enforcement Administration (IDEA), an agency focused solely on controlling illegal drugs    

“Until the government gets out of medical care, and out of proscribing severe limits on opioid therapy, grief will be a daily presence in pain patients lives. Others who can’t wait for common sense to infuse itself into mini-brained government officials will continue to end their lives in suicides. Now, there’s an epidemic the CDC should be working to eliminate!” she wrote.

‘Crazy Psychiatrists’

Borel holds particular disdain for the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) and its founder, Dr. Andrew Kolodny, a psychiatrist and addiction treatment specialist who has testified as a highly paid expert witness in lawsuits against opioid manufacturers.

“I think the government is stupid and they have a lot of hubris. That includes PROP, the tiny little band of crazy psychiatrists, the craziness and the haughtiness and the nonsense of PROP,” says Borel. “I think Freud would be appalled at these psychiatrists. They don’t have any feelings for patients. I don’t understand it.”

Borel dedicates chapters in her book to the “Suboxone Hoax,” “DEA Gestapo Actions” and the “Ominous Overreach of the Department of Justice.”

She also has a lengthy section on steps that pain patients can take to protect themselves, such as demanding the enforcement of HIPAA and other privacy laws, suing for negligence and medical malpractice, and refusing to pay for unnecessary medical exams and tests.     

“The more of these negligent practices that can be published, the sooner the public will stop putting up with the murdering of American pain care promulgated by the DOJ, the DEA and the VA,” she wrote. “You do not have to put up with the cold-turkeying of your opioid medication. This is flat out medical malpractice, will lead to rapidly declining health, unbearable pain, thoughts of suicide and too often suicide itself.”

American Agony is featured in PNN’s Suggested Reading section, along with other informative books on chronic pain and pain management.

Hearts Go Out to Our Personal Caregivers

By Barby Ingle, PNN Columnist

With Valentine’s Day coming up and February being Heart Month, I thought it would be fitting to say thank you to my caregiver and husband, Ken Taylor.

Ken has been working overtime this past year, and especially in the last few months as I have been ill with Valley Fever. He is one of those caregivers who dedicate their lives to helping pain patients, making our lives better just because he cares.

Like many caregivers, Ken is not paid for assisting me or the many others he has helped over the years. He does it out of love, respect and dedication.

Caregivers have a large responsibility once they take on the role. Ken has helped me with personal care, such as bathing, grooming, dressing me, and helping with laundry or other cleaning duties that were once things I loved doing.

Not being able-bodied has really put a lot of pressure on Ken, but he makes sure I am taken care of every day.

Luckily for me, he is also great at cooking. I am the worst cook I know and was that way even before I developed disabilities from chronic pain and other rare conditions.

Ken loves to cook and does most of the meal prep, shopping and other housekeeping duties. He does it with a smile most of the time.

KEN TAYLOR AND BARBY INGLE

Some other responsibilities Ken has taken on include help with packing for a trip, making sure my wheelchair was charged up, providing transportation and being a great emotional support for me. Many times over the years he was the one who made sure I was put together and looked “camera ready” when we had a TV crew filming or doing interviews as part of our advocacy for the pain community.  

Ken gets love, credit and thanks from me often, but I sometimes feel that his work – like most caregivers -- is not as appreciated by society. People don’t realize how much our caregivers help us.

Here is a short list of 10 things that caregivers do: 

1. Assist with personal care such as bathing, grooming, dressing, toileting, exercise, meal preparation, shopping, housekeeping, laundry and other personal errands

2. Care for the elderly such as orienting someone with Alzheimer’s disease or dementia

3. Communicating with healthcare providers as an objective advocate and relaying information from providers to other family members

4. Providing support as a stable companion and confidant in all matters personal, health-related and emotional

5. General healthcare such as overseeing medication use, appointment reminders and help with exercise

6. Home organization and cleaning

7. Mobility assistance such as help with getting in and out of a wheelchair, car or shower

8. Monitoring a care plan and noticing any changes in the individual’s health and reporting them to healthcare providers

9. Providing companionship and general supervision

10. Transportation such as driving to and from activities or running errands

Our caregivers also help us navigate and negotiate our way through the complex healthcare and education system. They are our voice when we’re not up to the challenge of a given situation.  

Accepting help from a caretaker doesn’t mean giving up your independence. By accepting help when needed, you can build on your ability to help yourself and spend your energy on enjoyable activities that would be missed otherwise. Caretakers provide guidance, family empowerment and appropriate help. That is why it is important to include them in your care decisions and in setting expectations.  

One goal I have as a pain patient is to increase my daily activities as much as I can. Sometimes for me this includes the use of a wheelchair and other assistive devices. I look at them as a way to get more activities done independently. For years I was unable to walk long distances, so I got a scooter and was able to ride two blocks over to our mailbox to pick up the mail. Once I got my scooter, it gave me more freedom and I was able to accomplish more, relieving some of the duties Ken was doing.  

Thank you with all my heart for my caregiver! May he always choose to help me when he can, take breaks when he needs them, and may we support each other in all our days. Thank you to Ken and all caregivers who are making our lives more manageable.   

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. 

Four Indicted in Compound Pain Cream Scam

By Pat Anson, PNN Editor

Greed and fraud have gone hand-in-hand in the opioid crisis, with drug and genetic test companies, pain clinics, spine surgeons, information technology vendors, addiction treatment doctors and even patient advocacy groups profiting from opioid hysteria or pushing bogus treatments.

You can add to the list pharmacies making compound pain creams.

A federal grand jury has indicted four people in Southern California for healthcare fraud, mail fraud, illegal kickbacks and money laundering as part of a scheme that defrauded two insurers into paying $22 million for medically unnecessary compound pain creams. Some of the creams cost as much as $15,000 per tube.

The fraudulent bills were sent to the U.S. military’s TRICARE health plan and the International Longshore and Warehouse Union’s Pacific Maritime Association Welfare Plan.

Prosecutors say the Orange County-based Professional Compounding Pharmacy (PCP) paid marketers about half of the payments it received from insurers as an incentive to recruit doctors and patients willing to write or accept pain cream prescriptions.

Patients were given $200 each to receive treatment at two bogus pain clinics and to participate in “sham clinical pain studies” on the effectiveness of compound creams as an alternative to opioids.

Among those arrested were James Bell, the owner of PCP and two medical marketing companies, and Dr. Michael Edwards, a Huntington Beach physician who allegedly set up the phony clinics.

Prosecutors say TRICARE was defrauded out of $19 million and the ILWU Plan lost $3 million. The scheme peaked in the first half 2015 and continued into 2016. The fraudulent billings dropped significantly in the second half of 2015, when the insurers reduced their reimbursement rates for compound creams.

This isn’t the first time compound creams have caught the attention of federal investigators.  A 2018 report from the Office of Inspector General for the Department of Health and Human Services found over 500 pharmacies had suspiciously high costs for compound creams and other topical medications billed to Medicare.

Medicare spending for topical medications has skyrocketed, rising from $13.2 million in 2010 to $323.5 million in 2016. Most were prescribed for pain, using ingredients such as lidocaine, a non-opioid anesthetic, or diclofenac, an anti-inflammatory drug.

Do compound pain creams work? A 2019 study at Walter Reed National Military Medical Center concluded the creams should not be used to treat chronic pain. One month after treatment began, researchers found no significant differences in the pain scores of patients who used compound creams and those who used placebo creams.

This Film Is Far from a Joke

By Dr. Lynn Webster, PNN Columnist

Good films entertain. Great films inspire. Sometimes, they even galvanize people to create a social movement against injustice.

I recently saw one of those rare movies that fall into the category of movies that can inspire: Joker.

The film moved me, and I think it has the capacity to raise the consciousness of other viewers, too. This is why I was surprised to read extremely negative critical reviews about Joker.

The Guardian dismissed the movie as being “shallow,” while the The New Yorker described the film as “numbing emptiness.” The New York Times labeled it as an “empty, foggy exercise in second-hand style and second-rate philosophizing.”

These reviewers all missed the point.

To me, Joker contains substance and in-depth messages about the shortcomings of our health care system, and the part that society's cruelty plays in the development of a psychopath. The gravity of the film caught me off guard.

I was expecting to see just another comic book/adventure movie, but this was far more than that. The film clearly shows a pattern of childhood trauma, repeated shame, income disparity, lack of health care, discrimination, corruption, and rebellion. In other words, Joker reflects real life through excellent and Oscar-nominated acting and production.

Joker demonstrates what happens if you take two people and put them in two different environments. You shower one person with money, love and other advantages, while you deprive the other of all those things.

WARNER BROS.

The movie shows that the result is the creation of one hero and one anti-hero.

Batman's nemesis, the Joker, didn't start off as a bad person. He once was a child named Arthur Fleck.

Fleck’s story begins with the physical abuse he suffered as a child at the hands of a harsh, rigid father and an enabling mother with serious mental health problems. She alleges that she had an affair with the wealthy businessman and politician Thomas Wayne (father of Bruce Wayne, who eventually becomes Batman).

Fleck believes his mother had the affair and, therefore, he is owed respect and support from Thomas Wayne. However, a callous and cruel man causes Fleck to doubt his parentage. Fleck learns from this man that he may not be Wayne’s child, and that his mother may have adopted him and kept the truth hidden from him. This deceit causes him unbearable shame.

In a startling contrast of good vs. evil, Bruce Wayne is blessed with a happy childhood, while Fleck suffers layer upon layer of abuse. His rage builds throughout the movie with recurring episodes of humiliation.

Fleck develops a neurologic disorder called Pseudobulbar Affect, a condition of involuntary, uncontrollable laughter and crying. The condition sets him up to be repeatedly isolated and ridiculed.

Fleck comes to see the inequity of his upbringing. Because the man he still believes may be his father withholds economic and emotional support from him, he experiences escalating anger and mistrust of politicians and the wealthy.

Fleck holds it together until his health care benefits are cut off and he can no longer see his therapist or receive medication. Then he snaps and becomes society's worst nightmare: the Joker.

Batman fans know the rest of the plot. So does anyone who follows the news.

What the Joker experiences, and the consequences of those misfortunes, happen all too frequently in real life.

Society's failure to provide treatment for people with mental illness, and the cruelty with which we shun them, create the seeds of school shootings, terrorism, mass murders and other horrible crimes.

People aren't necessarily born with a greater capacity for hatred than others, nor are they necessarily destined to become criminals. They may be born with mental illness, but it is often environmental factors — including society's lack of empathy, and its failure to treat them humanely and compassionately — that put them over the edge.

My hope is that audiences will see that a "joker" is made, not born. Some of the same ingredients that create a psychopath may also sow the seeds for drug abuse and many other societal pathologies.

Joker is not shallow or empty. It is a reflection of what society experiences when people receive too little empathy, too little love and too little support.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

Becky McCandless: ‘A Bright Light in a Dark World’

By Pat Anson, PNN Editor

Pain sufferers and patient advocates are mourning the loss of a trusted friend and colleague, Rebecca “Becky” McCandless. Becky passed away on January 30 at a hospice facility in Bloomington, Indiana after a brief battle with cancer. She was 59 years old.

Becky developed Arachnoiditis – a chronic and progressive inflammation of spinal nerves – after a botched epidural steroid injection in 2005. Her intractable pain became so intense that Becky considered suicide, until she found a doctor willing to prescribe high dose opioids.

Becky soon became an advocate for herself and others in the Arachnoiditis community. In 2015, she wrote one of the first guest columns to appear in PNN, defending the use of opioids and taking the CDC to task for its soon-to-be-released opioid prescribing guideline.

Becky said opioids had saved her life:

BECKY MCCANDLESS

“The CDC is clueless because they are recommending a cap on the daily dosages. How can they estimate a person’s pain levels? Everyone is different, and there are genetic differences and high metabolizers who need higher doses to control their pain. If that happens, my pain will be uncontrolled again, and I worry about my future. 

Is this fair to the thousands or even millions of pain patients who may suffer from Arachnoiditis, who have been harmed by the medical community and incompetence of the Food and Drug Administration? Even though the FDA issued a warning on steroids used for back pain, doctors are ignoring it and not telling their patients. We were harmed and now we suffer because doctors are turning us away.”

“Becky was a dear friend who overcame many trials, and she never gave up when she was handed great difficulties,” remembers Terri Anderson, a fellow Arachnoiditis sufferer who met and became friends with Becky on Facebook. “Becky was a bright light in a dark world. Her life was cut way too short.  I will miss her uplifting texts and phone calls, but I will always cherish her memory.” 

Becky was still mourning the recent deaths of her mother and sister when she learned she had an aggressive form of lung cancer. 

“Despite suffering tragic losses and incurable pain, Becky always made plans for better days ahead.  She encouraged others in our Arachnoiditis community and challenged misguided individuals on the topic of intractable pain with her Tweets and emails,” Anderson said.  

“What do you say about one of your dearest friends in the world, when you have shared with them both the daily challenges and physical pain of a devastating, chronic pain disease for so many years?” asks Denise Molohon, another Arachnoiditis sufferer. 

“Becky showed incredible strength and courage. She was a fighter. She rose back up each and every time, opening up the discussion and bringing suicide into the light, just as she had done with her own chronic pain disease. As a pain patient advocate, she helped multiple people, physicians, patients and organizations.” 

Becky and Molohon’s advocacy for Arachnoiditis led Vice President Mike Pence – then governor of Indiana – to proclaim a week in July 2015 as Arachnoiditis Awareness Week.  

After so many years dealing with the ravages of Arachnoiditis, Molohon says Becky’s diagnosis with late-stage cancer came as a shock.  

“Becky faced it like she had every major challenge, with the utmost bravery, a positive outlook and a fighting attitude,” Molohon said. “Becky was known for her huge heart. There wasn’t a single person or animal she wouldn’t help, didn’t matter the situation or problem. If she couldn’t find a way, she’d find someone who could. I will miss her huge smile, her contagious laugh and most of all her kind, generous heart.”

Becky was just days away from her 60th birthday when she died.

In lieu of flowers, memorial contributions can be sent in honor of Becky to the Adhesive Arachnoiditis Research & Education Project or to the Sycamore Land Trust.  Condolences to the McCandless family can be made here.

Study Finds Dentists Overprescribe Opioids

By Pat Anson, PNN Editor

Over half of the opioid prescriptions written by dentists in the United States exceed the 3-day supply recommended by pain management guidelines, according to a large new study that also found a stronger dose than necessary was prescribed nearly a third of the time.

The findings, published in the American Journal of Preventive Medicine, are important because dentists are responsible for about 10% of the opioids prescribed in the U.S.

“Dental procedures like extractions can leave patients with a lot of pain that needs to be managed, and many dentists are doing a wonderful job of managing their patients’ pain appropriately and responsibly,” said Jessina McGregor, a researcher in the Oregon State University College of Pharmacy. “But our findings suggest that there’s room for improvement among some dentists, improvement that could make a huge difference in our society as we try to combat the opioid crisis.”

McGregor and her colleagues reviewed insurance records from over half a million dental visits from 2011 to 2015. The study period was before the CDC released its controversial opioid guideline in 2016, so the findings may not reflect current practices in dental pain management.

Nevertheless, the study is the largest to date of dental visits in the U.S. that resulted in an opioid prescription.

Fifty-three percent of the time, patients were given more than the 3-day supply of opioids recommended by the CDC for most types of acute, short-term pain. Some dental associations recommend no more than two days’ supply – even for dental procedures associated with the severe pain.

In addition to the excess number of pills, researchers say the dose of opioids prescribed by dentists was stronger than what was medically necessary 29% of the time.

Men, young adults aged 18-34, and people living in the South were most likely to be prescribed opioids that were stronger than needed.

“One large potential area for improvement is the almost 30% percent of opioids that were prescribed following procedures where the pain intensity was expected to be mild and manageable by non-opioid analgesics like ibuprofen or acetaminophen,” said McGregor.

“Our statistical models suggest that even something as simple and straightforward as substituting a lower-potency opioid like hydrocodone for oxycodone could make an enormous reduction in overprescribing, as much as a 20% reduction.”

Researchers say prescribing guidelines tailored to dentists and oral pain are urgently needed to reduce excess prescribing . A small 2016 study of patients who had their wisdom teeth removed found that over half the opioids prescribed went unused. That suggests as many as 100 million excess pain pills are prescribed annually by dentists.

Anti-opioid activists have long claimed that young people can easily became addicted to opioids after dental surgery. But a large 2018 study found that the risk of long-term opioid use after wisdom tooth removal is relatively rare. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription.

Is It Too Early to Declare Victory in the Opioid Crisis?

By Pat Anson, PNN Editor

Wisconsin’s two U.S. Attorneys are taking a victory lap on the one-year anniversary of threatening letters they sent to 180 doctors, physician assistants and nurse practitioners in the state. The letters warned the providers that if they continue to prescribe “relatively high levels” of opioid medication — above doses recommended by the CDC — they could face civil or criminal prosecution.

In a joint news release this week, Scott Blader and Matthew Krueger, U.S. Attorneys for the Western and Eastern Districts of Wisconsin, said there has been “a substantial decrease in opioid prescribing” among providers who received the warning letters.

“Thanks partly to this initiative and the consistent efforts by the Wisconsin medical community to stem over-prescribing, Wisconsin has seen substantial progress in the fight against opioid abuse,” the news release claimed. “Total opioid prescriptions in Wisconsin have declined by 30 percent between 2016 and 2019, according to data from the Wisconsin Prescription Drug Monitoring Program. The letters sent by the United States Attorneys appear to have amplified this downward trend.” 

The release did not indicate if any provider who received the warning letter had been charged with a crime or if any of their patients has been harmed by their prescribing. The two U.S. Attorneys’ offices did not respond to a request for further information.

President Trump also claimed progress was being made in the overdose crisis during his State of the Union address on Tuesday.

“We are curbing the opioid epidemic, Drug overdose deaths declined for the first time in nearly 30 years. Among the states hardest hit, Ohio is down 22 percent, Pennsylvania is down 18 percent, Wisconsin is down 10 percent — and we will not quit until we have beaten the opioid epidemic once and for all,” Trump said.

Fentanyl Deaths Increasing

A closer look at the overdose numbers shows that it’s way too early to declare victory. A CDC report last week found that drug deaths declined over 4% in 2018, led by a significant drop in overdoses involving hydrocodone, oxycodone and other painkillers. But deaths linked to illicit fentanyl and other street drugs are surging – threatening to reverse the overall trend.

“One thing that we’re seeing is that the decline doesn’t appear to be continuing in 2019. It appears rather flat, maybe actually increasing a little bit,” said Robert Anderson, PhD, Chief of the Mortality Statistics Branch, National Center for Health Statistics. “We do know that deaths due to synthetic opioids like fentanyl are continuing to increase into 2019 and we’re seeing increases similarly with cocaine and psychostimulants with abuse potential, the methamphetamine deaths."

The most recent overdose stats from Wisconsin are also revealing, as the following two charts will show. While deaths in the state involving prescription opioids began declining in October 2017 -- over a year before the U.S. Attorneys even sent their warning letters – overdoses linked to fentanyl and other synthetic opioids are rising.

SOURCE: WISCONSIN DEPARTMENT OF HEALTH SERVICES

Nearly twice as many Wisconsinites are dying from heroin and fentanyl overdoses than from prescription opioids – a fact that is omitted in the news release from the U.S. Attorneys.

The only mention of fentanyl was the kind available by prescription. Prosecutors took credit for a Wausau physician being sentenced to three months in prison for writing “fraudulent fentanyl prescriptions” to six patients.  

A better representation of what’s happening in Wisconsin – and around the nation – is last month’s arrests of over three dozen people accused of trafficking illicit fentanyl, heroin and cocaine in Milwaukee. The drugs were allegedly shipped from Puerto Rico and Mexico, meaning drug cartels thousands of miles away recognize that there’s a demand for street drugs in Wisconsin’s largest city.

In 2019, 370 people died of drug overdoses in Milwaukee County. It was iIlicit fentanyl — not prescription opioids — that was the leading cause of death.

That doesn’t deserve a victory lap.

How to Win Your Disability Case

By Mia Maysack, PNN Columnist

A dear friend and I have ventured through the Social Security disability process. We’re both severely impacted by chronic head pain caused by traumatic brain injuries. Her pain stems from a motorcycle accident, while mine is a souvenir from bacterial meningitis. 

Our paths crossed while attending a lobbying event. We bonded instantly -- not only because we could relate to each other’s pain -- but because we pushed ourselves far past our limits. Accepting reality is tough on us both.   

Neither of us are fluent in the practice of law, although my friend worked as a paralegal prior to her health deteriorating. Together, we’ve cultivated a few main points to be used as a guide for others who may be considering their own pursuit of disability. 

First, take a moment to realize it requires much patience and time. For us there were moments of frustration and disheartenment. It’s highly probable that Social Security will deny your first claim and that you’ll need to appeal. This is how it goes for almost everyone. 

On average, a 2 to 3-year window can be expected from the time of filing your first claim until you are potentially approved. Each person’s case is different. It took four years before my application was approved.  

During the interim there’s still a need for money to survive and there are no guarantees that you’ll win.

It is your right to obtain legal help and many lawyers state they are not entitled to compensation unless benefits are granted. You do not necessarily need an attorney or representative, but doing so could speed up the process. Many of us have difficulty functioning, let alone keeping our thoughts straight, so appointing others such as a trusted friend or loved one is another possibility.   

It all boils down to what can be proven, so the most effective way to go about proving your claim is through documentation.  It is important to keep your medical records organized. Personal journals and diaries are also options, and compiling them could aid in coming to terms with whatever your situation is — an opportunity for accepting a “new normal.”       

Ultimately, the judge will want to see continuous visits with healthcare providers, focusing on the conditions that limit or prevent your daily activities and work. The invisibility of chronic pain is very difficult for some people to comprehend, so you will need proof.  

It is possible that a health care professional may not wish to complete the paperwork on their end because it only adds to their overflowing caseload. It’ll be your decision to continue hounding them for what you need or perhaps seek out a more empathetic provider and start over from scratch.   

What If I Win?

If you are granted disability benefits, it is imperative to take a few things into consideration.

First, celebrate the victory. And then be prepared for more work. Be sure to apply for secondary Medicare insurance within the allotted time frame in order to optimize the healthcare resources available to you.

A certain amount of income is permitted while receiving disability. Any sense of financial independence is encouraged, but returning even to part-time employment poses the risk of your case being questioned after your income caps out at a certain dollar amount. The assumption may be drawn that you are not only fine enough to return to work, but also that you're no longer in need of supplementary income.  

Reviews occur on a regular basis, demanding consistent proof that your situation is still as severe as it was. The Trump administration has proposed new rules that would increase the frequency of disability reviews, which some critics say could result in thousands of Americans losing their disability benefits.

Be sure to continue seeing your providers, taking your medications and doing what is expected of you. Noncompliance and missed appointments could lead to a denial of your claim, which is far from ideal due to the difficult reinstatement processes.  Keep track of relevant documents and maintain personal records of your own to present upon request.

The moment my disability paperwork went through, the insurance I obtained through the state immediately ended. Several months passed before coverage was reinstated. Thankfully, that was okay for me not be covered for a while, but for many others that could be detrimental.

Getting disability can be a daunting experience, but a wise person told me that I’d learn a lot going through the process. My friend and I prevailed. Hopefully, you will too.

Mia Maysack lives with chronic migraine, cluster headaches 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.

Pain and Anxiety Reduced in First New Zealand Cannabis Patients

By Pat Anson, PNN Editor

A study of the first patients prescribed medical cannabis after it was legalized in New Zealand in 2017 found that cannabidiol – the non-psychoactive ingredient in marijuana -- significantly improved their chronic pain and anxiety.

Researchers at the University of Auckland analyzed the health records of the first 397 patients prescribed cannabidiol (CBD oil) at a cannabis clinic in Auckland. The patients live with a variety of chronic pain conditions, including fibromyalgia, osteoarthritis, rheumatoid arthritis, neuropathy, multiple sclerosis, migraines and cancer.

Participants were asked to rate their pain, anxiety, mobility and depression before taking CBD oil and four weeks after starting treatment. The CBD doses ranged from 40mg/day to 300mg/day. The recommended daily dose was at least 100 mg.

Patients with non-cancer pain reported significant improvement in their pain, mobility, anxiety and depression. Some also said they slept better and their appetite improved.

Patients with neurological symptoms experienced no improvement with any symptom, and patients with cancer only reported improvement in pain.

Most patients said they were satisfied with CBD oil, with 70% reporting it was good, very good or excellent; while 30% reported no benefit.

Adverse side-effects, which included sedation and vivid dreams, were reported by about 10% of participants, with two patients (0.8 percent) reporting a worsening of a pre-existing condition.

“The study has limitations due to drop-out and other factors, but the findings are consistent with other evidence and underline the need for more research to allow us to fully realise the therapeutic potential of medical cannabis,” said Professor Bruce Arroll, senior author of the study and head of the Department of General Practice and Primary Healthcare at the University of Auckland.

“Our findings show that CBD is well-tolerated in most patients and can markedly ease symptoms in a range of hard-to-treat conditions, and that there are people keen to access this and self-fund the medication.”

Some patients chose not to take CBD oil because of its cost. Patients had to pay $300 (US) for 2500 mg of CBD oil, $150 for an initial consultation, and $75 for a follow-up.

“Our evidence of CBD’s potential benefits in treating pain and anxiety, if corroborated by future clinical trials, suggests we may need to consider subsidising medical cannabis,” said co-author Dr. Graham Gulbransen, who operates the cannabis clinic in Auckland. 

Because the study was observational and relied on patients self-reporting their symptoms, it did not establish a cause-and-effect relationship. It’s also possible the improvement in symptoms was due to a placebo effect.

The findings are published in the British Journal of General Practice Open (BJGP Open).

Does Discrimination Cause Blacks to Feel More Pain?

By Pat Anson, PNN Editor

Racial and ethnic bias is a fact of life that impacts almost every aspect of our society – and healthcare is no exception. Research has shown that African-Americans are more likely to be undertreated for pain compared to white Americans, and that blacks are less likely to be prescribed opioid pain medication than whites.

Part of that stems from a false belief that there are biological differences between blacks and whites that cause African-Americans to feel less pain.

New research published in the journal Nature Human Behaviour disputes that stereotype, suggesting that African-Americans experience more pain due to the lasting effects of discrimination and other stressful life experiences.

In a small study led by researchers at the University of Miami, 28 African-Americans, 30 Latinos and 30 whites were subjected to a series of painful heat tests on their forearms while undergoing MRI brain scans.

The African-Americans not only rated their pain more intense and unpleasant than the other two groups, but the MRI’s found that the parts of their brains that process pain signals became more active than their counterparts’ as the temperature of the heat probes increased.

“There's evidence that both the general public and clinicians believe that African Americans are less sensitive to pain than non-Hispanic whites; yet research, including our own, shows exactly the opposite." said lead author Elizabeth Losin, PhD, an assistant professor of psychology at the University of Miami.  "Minorities, particularly African Americans, actually report more pain."

Losin began her research eight years ago while at the University of Colorado, recruiting volunteers in the Denver area. In addition to the heat tests and MRI scans, all participants completed questionnaires about various aspects of their lives, including unfair social treatment, discrimination and their trust in doctors.

Using the MRI brain scans, Losin and her colleagues identified two areas of the brain, the ventral striatum and ventromedial prefrontal cortex, which responded to pain more strongly in African Americans than the other two groups. Prior research has found that these two brain regions also respond more to pain signals in chronic pain patients.

“Our findings suggest that the link between chronic pain and ethnic differences in pain sensitivity may lie in the chronic stress associated with discrimination. Discrimination has been consistently associated with chronic stress and other adverse health outcomes in AA (African Americans) and other minority groups,” Losin wrote.

“It is also plausible that the higher pain sensitivity we and others have observed in AA compared to WA (White Americans) participants may be related to previous negative experiences with medical care in particular, which are more common in AA compared to non-Hispanic WA populations.”

Previous studies have found that childhood trauma, domestic violence and other stressful life situations can also increase the likelihood of chronic pain – so this new research does not prove that discrimination alone contributes to the increased risk of pain. Nevertheless, it lays the groundwork for future studies on the relationship between pain and discrimination.

"These findings exemplify how neuroimaging is teaching us that there are multiple contributions to pain," said co-author Tor Wager, PhD, a professor of neuroscience at Dartmouth College. "We need to consider the broader psychological and cultural setting when we think about what is underlying pain and how to address it."

Losin is continuing her research by studying the relationship between patients' trust in their doctors and their experience with pain.

"It's a common misconception that any difference you see between groups of people must be an intrinsic difference, rooted in our biology. But the differences we found in this study were related to people's life experiences," she said. "It reaffirms our similarities and provides hope that racial and ethnic disparities in pain can be reduced."

Fentanyl’s Relentless March

By Roger Chriss, PNN Columnist

There is simply no good news where illicit fentanyl is concerned. A DEA report last week called fentanyl the “primary driver” of the opioid crisis, with fentanyl widely available as a street drug in the Midwest, Great Lakes, Northeast and Southwestern states.

The much-feared possibility that the fentanyl crisis is spreading to other parts of the country is proving accurate, and efforts to intervene are not going well.

According to the San Francisco Chronicle,, the number of fatal heroin and fentanyl overdoses more than doubled in the city from 90 in 2018 to 234 last year. UCLA drug researcher Dan Ciccarone, PhD, told the Chronicle that “Fentanyl’s not going away. We have to learn to adapt to it.”

A January bust in Arizona supports this claim. PNN reported that nearly 170,000 counterfeit oxycodone pills made with fentanyl were seized in Phoenix by the DEA and local police.

Similar trends are seen in Washington state, where preliminary reports by law enforcement for 2019 show “notable increases” in illicit fentanyl seizures. A December 2019 raid in North Seattle netted 2,700 counterfeit pills and a manual pill press.

Nationally, fentanyl has been a worsening trend for years. The CDC’s Provisional Drug Overdose Death Count shows a steady increase in fentanyl and other synthetic opioid overdoses through June 2019.

COUNTERFEIT OXYCODONE

By comparison, overdose fatalities for natural and semi-synthetic opioids, which includes oxycodone and hydrocodone, are trending downward.

The federal government is struggling to find an effective response. Reuters reports on a newly proposed measure that would allow the DEA to permanently place all fentanyl analogues into the same legal category as heroin and cocaine, making it easier to prosecute drug dealers trafficking new chemical versions of fentanyl.

But as Reuters notes, the DEA found only two new types of fentanyl analogues in 2019, and saw a significant drop in mail seizures of the drug from 2017 to 2018. In other words, fentanyl trafficking is evolving faster than law enforcement and regulatory responses can keep up. The drugs are being smuggled into country, assembled locally and distributed clandestinely -- all outside the scope of conventional interdiction techniques and supply-side interventions.

This underscores the value of a more comprehensive approach to the opioid crisis described by National Institute on Drug Abuse director Nora Volkow, MD, who recently visited a needle exchange program in Philadelphia.

“Our visit to Philadelphia drove home for me why we need to address the stigma that still surrounds opioid addiction and its treatment. It also drove home why addressing the crisis will require a comprehensive approach — including treatment with medications along with harm-reduction (like needle exchange), as well as case management and an array of nonmedical services that can attend to people’s basic needs, including helping them build meaningful social relationships,” Volkow wrote in her blog.

The U.S. has seen great success in reducing cancer deaths. A combination of public health prevention, screening and monitoring of at-risk populations, research into new treatments, and clinical care have brought down cancer death rates every year since the early 1990s.

Near real-time monitoring of disease is not impossible. In a matter of days, researchers at Johns Hopkins University created a global report on the coronavirus that is updated daily. A similar tool for the overdose crisis would be invaluable.

Illicit fentanyl is rapidly penetrating drug markets as a drug of abuse and as an adulterant in heroin and counterfeit medications. Coupled with a resurgence in cocaine and methamphetamine, the overdose crisis is rapidly becoming a syndemic that is spreading nationwide. Only a comprehensive approach will lead to a sufficient response.

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

Study Finds Kratom Effective for Pain Relief

By Pat Anson, PNN Editor

The herbal supplement kratom is an effective treatment for pain, helps users reduce their use of opioids and has a low risk of adverse effects, according to a new study by researchers at Johns Hopkins University School of Medicine.

The study is based on an online survey of nearly 2,800 kratom users and was funded by the National Institute on Drug Abuse (NIDA). The findings are notable, because they debunk many of the claims made by other federal agencies that kratom has a high potential for abuse and should be banned because of its opioid-like qualities. Kratom is currently illegal in six states, and several cities and counties have enacted local ordinances banning sales.

“There has been a bit of fearmongering, because kratom is opioid-like, and because of the toll of our current opioid epidemic.” said lead author Albert Garcia-Romeu, PhD, an instructor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine

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

Banning kratom would be a mistake, according to the researchers, who say kratom actually helps reduce opioid abuse. About 40% of those who participated in the survey said they took kratom to treat opioid withdrawal. Of those, 35% reported going more than a year without taking prescription opioids or heroin. 

“There is a high likelihood that banning kratom or its constituents would compel individuals who are presently using kratom for pain relief or opioid use reduction to return to using prescription or illicit opioids with a known risk of dependence and possible lethal overdose,” Garcia-Romeu and his colleagues reported in the journal Drug and Alcohol Dependence.

Over 91% of those surveyed said they would endorse kratom for pain relief, and about two-thirds would recommend it as a treatment for anxiety and depression.

Kratom ‘Relatively Safe’

Survey participants also completed a checklist to assess whether they had a substance use disorder. Only 2% met the criteria for moderate or severe abuse of kratom, while about 13% met some criteria for a kratom use disorder. That is comparable to about 8% to 12% of people prescribed opioid medication who became dependent, according to NIDA.

“Both prescription and illicit opioids carry the risk of lethal overdose as evidenced by the more than 47,000 opioid overdose deaths in the U.S. in 2017,” says Garcia-Romeu. “Notably there’s been fewer than 100 kratom-related deaths reported in a comparable period, and most of these involved mixing with other drugs or in combination with preexisting health conditions.”

About a third of the survey participants reported having mild unpleasant side effects from kratom, such as constipation, upset stomach or lethargy, which usually resolved within a day. About 10% reported having withdrawal symptoms once the kratom wore off, with less than 2% saying their withdrawal was severe enough to seek medical treatment.

“Although our findings show kratom to be relatively safe according to these self-reports, unregulated medicinal supplements raise concerns with respect to contamination or higher doses of the active chemicals, which could increase negative side effects and harmful responses,” said Garcia-Romeu. “This is why we advocate for the FDA to regulate kratom, which would require testing for impurities and maintaining safe levels of the active chemicals.”

The Johns Hopkins findings are similar to those from a 2016 PNN survey of over 6,000 kratom consumers, in which 98% said kratom was very effective or somewhat effective in treating their medical condition. Over two-thirds rejected the idea of having the FDA regulate kratom, fearing it would lead to higher prices or because it would require a prescription.

While there are inherent problems with online surveys of self-selected kratom users, there is a notable lack of clinical studies that definitively prove whether kratom is effective or harmful — forcing researchers and regulators to rely mostly on anecdotal evidence.

In 2016, the DEA tried unsuccessfully to list kratom as a Schedule I controlled substance, claiming it was an “imminent hazard to public safety.” The CDC has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The FDA says kratom is addictive and not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products.

Garcia-Romeu cautions consumers not mix kratom with other drugs or medications, and to talk with their doctor before taking any supplement.

“Kratom doesn’t belong in the category of a Schedule I drug, because there seems to be relatively low rate of abuse potential, and there may be medical applications to explore, including as a possible treatment for pain and opioid use disorder,” he said.