Clearing: What to Expect From a New Digital Pain Care Company

By Pat Anson, PNN Editor

The last few years have seen rapid growth in telemedicine and the digital healthcare market. You can consult with a doctor online and get treatment for just about every ailment, from acne and allergies to hair loss and erectile dysfunction.

Clearing, a subscription-based digital health service, is the first to focus exclusively on treating chronic pain, a global market worth over $80 billion a year that has 50 million potential customers in the U.S. alone. The company recently announced $20 million in funding from private investors.

“What we’re trying to do is build a digital healthcare platform for chronic pain sufferers,” says Dr. Jacob Hascalovici, Clearing’s co-founder and Chief Medical Officer. “We feel that chronic pain is very unique. It’s often invisible. And it really needs to start with us listening to you and designing a treatment plan that is most suitable for an individual’s needs.”

Hascalovici, a neurologist with a background in interventional pain management, says Clearing is initially focused on treating muscle, joint and neuropathic pain. At this early stage, the company does not treat more complex chronic pain conditions, such as headaches or visceral pain – the latter generally covering pain caused by infection, trauma or disease.

“Chronic pain is a very complicated space and it’s the kind of field where I think we first need to prove our ability to operate in this field. What we are focusing on primarily at launch, but by no means are restricting ourselves to, is what we call ‘Stage One’ intervention,” Hascalovici told PNN.

No Opioids or Pills

If you are curious about signing up with Clearing, there are three caveats to be aware of.

First, Clearing does not prescribe opioid pain relievers. In fact, it doesn’t offer any kind of oral medication, injection or surgery. Patients will receive topical compound creams containing over-the-counter and prescription strength analgesics (primarily NSAIDs, lidocaine and muscle relaxers), CBD cream, dietary “nutraceutical” supplements, and a personalized home exercise program you can watch online.

Second, Clearing is not covered by insurance. Depending on the plan they select, subscribers will pay anywhere from $25 to $80 a month. You’ll need to pay $10 to cover shipping and handling for the company’s “free trial.”    

Third, you’ll never actually see or speak with a physician on Clearing’s platform. All communication is handled by text messaging through the company’s online message portal.

Signing up is relatively easy. You’ll be asked to locate your pain on an anatomical figure and then describe it. Is the pain stinging? Aching? Throbbing? How long have you had it?

When I went through the signup process and indicated I had knee pain, I was never asked if it was treated or what the diagnosis was (mine was tendonitis). Hascalovici says Clearing’s physicians prefer to make their own diagnosis, although how they can do that for knee pain without ordering x-rays or imaging — or even seeing my knee — is a bit puzzling.

If you have them, you can upload your medical images to Clearing for a physician to review, although it’s not necessarily needed or even desirable.

“The imaging in chronic pain medicine doesn’t always correlate with the patient’s symptoms. And sometimes the pre-existing diagnosis can be confusing. If you’re suffering from chronic pain and the diagnosis led to a perfect treatment, then you’d probably not be in a chronic pain management doctor’s office,” Hascalovici explained.

“We’ve designed the experience at Clearing to most closely mimic an in-person visit with a chronic pain specialist. So, any patient coming into my clinical practice would first be evaluated.  We would devise a diagnostic hypothesis and then prescribe a person a home exercise program or structured physical therapy program, followed by topical pharmacotherapy. We really believe in this multi-disciplinary approach to the management of chronic pain.”

When signing up for Clearing, be prepared to give a lot of personal information, just as you would when visiting any doctor for the first time. You’ll be expected to provide a photo ID, credit card information, home address and cell phone number, among other things.

The boilerplate fine print in Clearing’s Terms of Use refers to all patient information as “User Generated Content” that becomes the property of the company and can be used “in whatever manner Clearing desires.” The company says it is not subject to HIPAA rules that protect patient privacy, but would “strive to comply” with them.

The fine print also indicates that Clearing does not consider itself a medical group or practice. All medical advice and treatment through its online platform is provided by Relief Medical Group, an independent group of practitioners where Hascalovici is co-director.

The bottom line for patients is that Clearing probably won’t work if you have severe chronic or intractable pain. But if you have simple muscle aches or joint pain, Clearing’s creams and home exercise programs may be worth a try. The low cost and convenience of telehealth are advantages over a traditional office visit, and there’s no waiting for an appointment.

Opioid Tapering Is Not the Solution to the Overdose Crisis

By Roger Chriss, PNN Columnist

The lawsuits against opioid manufacturers and distributors assume that the fault of the overdose crisis lies with manipulative marketing and medical mismanagement of patients and communities. There is some truth to this, as the HBO documentary “The Crime of the Century” describes. But there is also a lot missing.

The lawsuits and most of the media assume that the solution to the overdose crisis is to reduce opioid prescribing. But a decade of public health data has shown a more complicated picture, as prescribing levels and overdose rates have gone in opposite directions. And changes in prescribing policy were implemented in a heavy-handed way that destabilized patients and nurtured street drug markets.

Policy makers and anti-opioid activists made the overdose crisis worse, as Maia Szalavitz explains in Scientific American.

“If the goal of reducing prescribing were actually to help addicted people and improve pain care, these patients could have been contacted and given immediate access to appropriate treatment for their medical conditions when they lost their doctors. This would have left far fewer customers for dealers,” Szalavitz wrote.

“Instead, however, supply was simply cut and, in some cases, thousands of people were left to suffer withdrawal at the same time. As the crackdown progressed, even doctors who see their patients as benefitting from opioids began either to reduce doses or stop prescribing entirely for fear of being targeted by police and medical boards.”

Risks Are Not Uniform

Under-girding this policy of reduced prescribing is the assumption that risks don’t vary. In other words, it was assumed the risk of addiction and overdose is the same on the first day of opioid use as it is on the 10th or 100th day, regardless of age, gender or other factors.  

But a recent Australian study of patients on opioid medication showed that opioid use and misuse are more complex. Researchers found there was “substantial variation” in how patients answered questions from year to year about their opioid use and behavior. More patients stopped taking opioids on their own than were diagnosed with opioid dependence, suggesting that long-term opioid use does not automatically lead to misuse or addiction.

Further, the risks seem to rise quickly during the first week or two of opioid use, then drop to a stable level. That level is typically maintained over time, except in the face of changes in health status, psychosocial trauma or other medication use.

The risks seem to rise again when patients are taken off opioids. A 2019 study found that tapering actually increased the risk of a patient dying, particularly if the tapering was done quickly or non-consensually.

Irresponsible Advocacy

Anti-opioid advocacy groups like PROP (now officially called Healthcare Professionals for Responsible Opioid Prescribing), FedUp and PharmedOut are quick to point out the risks of addiction and the wrongdoings of Big Pharma.

But there is a clear failure by these groups to address the opioid hysteria they helped create or the unintended consequences of opioid deprescribing, such as sickle cell patients losing access to opioids because of what the NIH calls “rampant fear of opioid addiction and overdoses.” A similar rush to deprescribe is even impacting hospice and cancer patients.

The overdose crisis is rapidly evolving. Drug researcher Dan Ciccarone, PhD, of the University of California, San Francisco School of Medicine, told Buzzfeed that the U.S. is entering a “fourth wave” in the overdose crisis, in which illicit fentanyl and methamphetamine are the main problems, not prescription drugs.

The U.S. has both systemic and systematic issues that have impeded progress in the overdose crisis for decades. Szalavitz, Ciccarone and many others have pointed to better ways forward. From gentle transitioning of patients to harm reduction for people at risk, the U.S. could have done much better, as history now shows. Hopefully, we won’t wait again for history to tell us what we should be doing.  

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. 

Pew Cherry-Picked Patient Cases in Stem Cell Report

By A. Rahman Ford, PNN Columnist

As a self-professed vehicle for public policy-making, the Pew Charitable Trusts has released a new report that aims to protect Americans from the harms of “unapproved” stem cell therapy.

Regrettably, the 34-page report relies on cherry-picking of patient cases, supports an aggressive crackdown on stem cell clinics by the FDA, and curiously take the undemocratic position of supporting online censorship.

Like a similar report in 2019, Pew’s stated intent is a noble and valuable one: to protect patient health. The new report correctly asserts that “stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases.” Unfortunately, what follows is a porous analysis that includes woefully unsubstantiated assumptions and misdirected conclusions.

To support its claims of an ever-increasing number of harmful “adverse events” resulting from unapproved stem cell treatments, Pew researchers looked at peer-reviewed journals, government and news media reports, the FDA’s adverse event reporting system, and online consumer reviews of stem cell businesses from 2004 to 2020.  

Over this 17-year period, Pew identified 360 people who had adverse events involving stem cells. Most of the adverse events (AEs) were relatively minor, such as bacterial infections, but some were serious enough to result in blindness, organ damage or even death. While each case is regrettable, keep in mind that over 250,000 people in the U.S. die every year from medical errors.

The Pew report assumes that adverse events from stem cells are under-reported, but provides no evidence for this claim. On the basis of the cases found, Pew concludes that “increased FDA enforcement action” against stem cell clinics is needed. The report also calls on state agencies, state legislatures and professional organizations to get involved.

Less Than Definitive Definitions

On its face, Pew’s evidence against stem cells seems somewhat convincing. But upon closer inspection, it has serious and alarming methodological flaws.

First, the report’s definitions are problematic. For example, Pew defines an adverse event as “any undesirable experience associated with the use of a medical product in a patient.” This definition is so broad it can encompass almost anything. Furthermore, it’s conceptually clumsy to equate “adverse” with “undesirable” – the two are simply not the same in medicine, academia, policy, or in simple common sense.

To make matters worse, Pew conflates “unproven” therapies with “unapproved” therapies, when the two are very different. “Unapproved” means it’s not FDA-approved, which covers most products offered by stem cell clinics. Thai’s fine. But Pew then asserts that the stem cell products are also “unproven” because they lack “definitive, high quality evidence of safety and efficacy.”

To assert that stem cells products such as stromal vascular fraction (SVF) and autologous mesenchymal stem cells are all “unproven” simply defies the reams of published studies to the contrary. There are many examples where stem cell therapies were “proven” to safely and effectively help people, even when they are not FDA-approved.

And the “safe and effective” products the FDA has approved harm people all the time. Thus, the question remains, if “unproven” and “unapproved” are going to be used interchangeably, as the Pew report admits, then what is the point of having definitions in the first place?

Cherry-Picked Cases

Second, the Pew report wrongly assigns all cases equal evidentiary weight, regardless of the source from which they were collected.

Is it methodologically honest to give a case from a peer-reviewed academic journal the same scientific and evidentiary value as a case found on Yelp, a website where people go for reviews of Philly cheesesteaks and fish tacos? And how exactly did Pew investigate the veracity of posts it found on Facebook and Google? It didn’t.

Pew concedes that its social media analysis did not find “many new serious or life-threatening” adverse events. It also acknowledges that not all the consumer reviews about stem cells were negative, stating that “many, in fact, were positive.” Pew’s analysis excluded the positive reviews because it didn’t consider them reliable, but inexplicably included the negative ones. Why?    

Could it be that Pew was only looking for data that supported a conclusion that it had already arrived at?  If so, that would be unprofessional, unscientific and very, very troubling.

To cherry-pick some opinions over others is also undemocratic. This would be ironic because on its website, Pew purports to “invigorate civic life by encouraging democratic participation and strong communities.” Pew also maintains that it is inspired by America’s Founding Fathers and their belief in “the importance of an informed democracy.”

Given the report’s skewing of data, perhaps for Pew it’s only democracy for some.

This conclusion would coincide with Pew’s continued urging of online media platforms to censor stem cell information it finds disagreeable. In its report, Pew implores “companies that manage online platforms [to] do more to limit the spread of misinformation, and prevent clinics from advertising their products on their platforms.”

Pew would do well to realize that speech – online or otherwise – is a constitutionally protected freedom, and the perimeter of the public square should not be circumscribed so as to serve unspoken agendas.

All in all, the Pew report’s lack of methodological rigor undermines much of its credibility. To be sure, when any American is harmed by any medical procedure it should be taken seriously. And most stakeholders agree that reasonable regulations and enhanced data collection are welcome.

But the Pew report ignores the critical point that the current FDA regulatory scheme for stem cells is unduly burdensome and in desperate need of change. Cracking down on stem cell clinics won’t solve the problem of chronic pain, and it won’t solve the problem of pills and surgeries that don’t work, harm or kill. All it will do is discriminate against persons with disabilities and poor people. It doesn’t get more undemocratic than that.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

Coping With Pain and Isolation During the Pandemic

By Alexa Mikhail, The 19th

Originally published by The 19th

Even before the pandemic, Sabra Thomas ordered her groceries. The 33-year-old has not been able to push a cart and her walker at the same time for years, and she can’t pick up heavy cases like water. 

It’s the pain — the invisible enemy she faces daily.  

In March 2020, when the pandemic set in and grocery orders surged, Thomas was never able to get hers delivered in time. She had to start placing orders five weeks ahead, and they kept getting canceled. 

“I desperately needed food,” said Thomas, who has lived alone for the bulk of the pandemic. “And because of my chronic pain and feeling like food options were limited, I was rationing out my meals. Many days I had to figure out how to balance taking meds and how much to eat.” 

Tasks that seem quotidian to so many have brought Thomas anxiety for years. At age 12, Thomas was diagnosed with Ehlers Danlos — a degenerative chronic pain condition affecting connective tissue, primarily the skin, joints and blood vessel walls. 

She suspected, and later confirmed, that she was having hip dislocations all through childhood, which were constantly dismissed by doctors when she was younger, she said. When she finally received her diagnosis, she was told the disease would only progress as she got older. In high school, she was able to be more active, but the plays Thomas used to act in, the basketball and dance that defined her when she was growing up, have become nearly impossible activities now. The former dance instructor hasn’t danced in over a year. 

On a good day prior to the pandemic, Thomas might go dance for a few hours with friends — though she would pay for it the next day. On a bad day, she was completely bedridden, usually waking up with joint dislocation, a migraine, vertigo or a combination of the three. The pain is always hidden.

“With a chronic pain condition, it’s like ‘OK, you look normal.’ I used to hate when people said that. What the heck does that mean, I look normal?” Thomas said. “I don’t feel normal.” 

Now, Thomas lives in an apartment alone in Birmingham, Alabama, so she can be closer to family. Before moving, she hadn’t seen her family for a year. After pandemic-induced isolation and struggling to secure medical appointments, Thomas is tired. As a Black woman with chronic pain, she’s had to be her own medical advocate, she said. 

“I’m here by myself. All I can focus on is my pain and the loneliness,” Thomas said. “I was feeling trapped, hopeless in all facets of my life.” 

Disparities in Pain Care

In the United States, 70 percent of people struggling with some form of chronic pain are women, despite 80 percent of studies on pain involving either men or mice. It’s a common pitfall of medical research that experts say could be because it is harder to get women of childbearing age to participate in studies. While research on pain is difficult given the ambiguous factors involved in feeling it, women report experiencing higher levels of pain than men, according to a study in Scientific American magazine. 

There are vast disparities across both racial and gender lines when it comes to the validation of pain and getting treatment. Black patients are 40 percent less likely to receive medication for acute pain compared to White patients, and 34 percent less likely to be prescribed opioids, according to an analysis by the American Journal of Emergency Medicine. 

That’s become even more difficult in the pandemic, experts say.

Thomas has long felt like she’s screaming to an empty auditorium when it comes to her checkups. Even when she was seeing doctors in-person, she seldom felt truly believed. In 2018, she waited months to see a top gynecologist for the excessive bleeding and pain she was having. Knowing her diagnosis, she thought the doctor, who was a White man, would surely run tests. He insisted it was her job — at the time she worked in social security as a customer service representative — that was making her stressed. 

“I just felt very deflated,” Thomas said. “I felt like he was making me question myself.” 

When Thomas went to get a second opinion by a doctor, a woman of color, she immediately found out she had to go into emergency surgery for eight inflamed fibroids linked to her Ehlers Danlos. 

Now, Thomas is hardly able to secure in-person appointments because of a backlog from the pandemic. Virtually it’s much harder for her to show a physician her pain and explain her experience, she said. 

The ambiguity around how people express their pain, coupled with ingrained biases and stereotypes, makes it hard for the most marginalized people to be taken seriously when explaining their pain, said Janice Sabin, a researcher on implicit bias in medicine at the University of Washington. This notion of “it’s all in your head” or “you’re crazy,” dates back a century when it comes to women and women of color experiencing chronic pain, Sabin said.

“The lived experience of discrimination is incredibly damaging. It is an emotional burden, but it’s also something that can be tapped intergenerationally,” Sabin said. “Women were considered to be in the 1950s, for example, ‘hysterical’ — just that legacy of not believing women and women being looked at as weak.”

Being Your Own Advocate

Having to be your own advocate is the hardest, Thomas said. And especially during a pandemic, it is nearly impossible to stay on top of your own appointments and procedures. Typically, Thomas sees a specialist once a month and a therapist once a week. This year, Thomas tried to get into a new primary care doctor. She called to schedule in February for an appointment, and the earliest opening was in July. For someone in her level of constant pain, the wait is excruciating, forcing her to take her care into her own hands, doing her own medical research and reaching out to countless experts for advice and help. 

“I had so much medical documentation,” Thomas said. “I could have made my own library.”

Telehealth skyrocketed at the beginning of the pandemic. Between June 26 and November 6, of 2020, 30.2 percent of weekly health center visits occurred via telehealth, according to the Centers for Disease Control and Prevention. Telehealth has made it easier for those in rural areas or for people who have children at home to get appointments, and experts say it’s here to stay: 83 percent of patients expect to use virtual appointments after the pandemic. 

On the flip side, it is more difficult for those like Thomas to feel completely understood. Vulnerable pain patients can be seen as seeking unneeded drugs when they simply need any remedy to get them out of bed, said Shoshana Aronowitz, a researcher of racial disparities in pain medications and the opioid crisis at the University of Pennsylvania. In the pandemic, the limited access to pain doctors affects those most marginalized, specifically women, people of color and LGBTQ+ people who may have previously experienced discrimination in treatment. 

“We’ve gotten into the situation where people, especially Black Americans, have less access to pain care, and then also have less access to substance use disorder treatment. If people don’t have access to other types of treatment, that’s not OK,” Aronowitz said. 

She advocates for a system in which the most marginalized are prioritized for a holistic approach to care that includes both telehealth and in-person therapy and remedies post-pandemic. There are a handful of pain centers across the country that view pain in this way, but with waitlists and costs for initial evaluation, they remain very inaccessible, experts said. 

“In primary care, integrated team care is a model that is being advanced,” Sabin said. “Sort of having this medical home all in one place, so people aren’t being sent to a counselor for this and somewhere else for that. The providers in that model can discuss patients together. Everything is in one spot.” 

Similar to chronic pain patients, many of whom struggle with undiagnosed ongoing medical problems, long-haul COVID patients face that same uncertain battle. With doctors spread thin working to address those with ongoing COVID-19 symptoms, Sabin hopes this is a turning point in which mysterious lingering chronic pain conditions can be looked at and appreciated in a new light. 

Thomas decided last month to leave her job as a customer service representative and apply for disability status. Taking the phone calls her job required all day, especially when her pain flared up, was just not doable. 

The pandemic pushed her to make changes that will help her take care of herself and the uncertainty of her condition. She still feels ashamed: That she can’t function to the extent she desires, that she has to endure the financial instability of a monthly check. She still hasn’t told many of her friends about quitting her job. When she has Zoom calls, she usually avoids the topic of work. 

But still, she said, she is now ready to own her reality.

“For us in chronic pain, we’re always like, ‘We just got to keep going.’ ‘We push through it.’ And then by the time we finally stop, our body’s completely broken,” Thomas said. “So I’m trying not to do that because I am 33. I’m not 103.” 

“Ironically, the pandemic gave me an out,” she added. “It was the catalyst to push me to make a change for myself, for the good of my health and well-being.” 

Patients in Addiction Treatment Often Stigmatized by Doctors

By Pat Anson, PNN Editor

Most chronic pain patients are well aware of the stigma associated with using opioids. A recent PNN survey of over 3,600 pain sufferers found that about a third had been abandoned by a doctor (29%) and many were unable to find a new physician to treat their pain (36%).

“I was abandoned by the doctor who did my last operation,” a veteran with CRPS told us. “I should have been put on whatever pain medication possible to ease my pain. I wasn't. I'm not a drug addict and I damn sure don't appreciate being treated like one!”

“The stigma and refusing to treat needs to be addressed. Stigma by pharmacists, doctors and society is cutting life short. Patients have become social pariahs. Severe surgeries are conducted and patient is sent home with Aleve. It’s barbaric, cruel and inhumane,” another patient said.

The stigma also extends to people being treated for opioid use disorder (OUD), according to a new study of patients in the Canadian province of Ontario. Researchers at St. Michael's Hospital in Toronto analyzed the health records of nearly 155,000 patients who were discharged by a primary care physician between 2016 and 2017.

The research findings, recently published in PLOS Medicine, found that patients prescribed an addiction treatment drug such as Suboxone or methadone were 45% less likely to find another primary care provider (PCP) in the next year compared to other patients.

"There are considerable barriers to accessing primary care among people who use opioids, and this is most apparent among people who are being treated for an opioid use disorder. This highlights how financial disincentives within the healthcare system, and stigma and discrimination against people who use drugs introduce barriers to high quality care," said lead author Tara Gomes, PhD, a researcher at St. Michael’s Li Ka Shing Knowledge Institute.

"Ongoing efforts are needed to address stigma and discrimination faced by people who use opioids within the health care system, and to facilitate access to high quality, consistent primary care services for chronic pain patients and those with OUD.”

Surprisingly, Gomes and her colleagues found that pain patients on long-term opioid therapy in Ontario did not have a harder time finding a new PCP. That finding is at odds with a recent study in the United States, which found that nearly half of primary care practices would not accept new patients who were already taking opioids.

Researchers think the discrepancy may be due to the U.S. having a private healthcare system, where there is a financial incentive to drop patients with complex health needs, as opposed Canada’s publicly funded healthcare system.

During the gap in their primary care coverage, about 5% of Ontario patients on long-term opioids visited an emergency room, suggesting that the loss of a PCP led to further health problems that made them seek care in a hospital. In effect, patient abandonment not only made those people sicker, it shifted the financial burden of their healthcare to someone else.

“Although the structure of primary care differs across North America, our findings suggest that even in a province with a publicly funded healthcare system that has undergone considerable primary care transformation, barriers to care continue to exist for people who use opioids, particularly those with an OUD,” Gomes wrote.

The researchers said insurance reimbursement policies should be reviewed to ensure that they do not lead to the discrimination and stigmatization of patients. Doctors should also be educated on how abandoning or discharging patients can be harmful.

Patient abandonment may have grown worse since Canada adopted a new opioid prescribing guideline in 2017. A 2019 survey of patients by the Chronic Pain Association of Canada found that about a third of patients had either been abandoned by a doctor or their doctor refused to continue prescribing opioids to them.

Long-Haul Covid Draws Needed Attention to Dysautonomia

By Cindy Loose, Kaiser Health News

The day Dr. Elizabeth Dawson was diagnosed with covid-19 in October, she awoke feeling as if she had a bad hangover. Four months later she tested negative for the virus, but her symptoms have only worsened.

Dawson is among what one doctor called “waves and waves” of long-haul covid patients who remain sick long after retesting negative for the virus. A significant percentage are suffering from syndromes that few doctors understand or treat. In fact, a yearlong wait to see a specialist for these syndromes was common even before the ranks of patients were swelled by post-covid newcomers. For some, the consequences are life altering.

Before fall, Dawson, 44, a dermatologist from Portland, Oregon, routinely saw 25 to 30 patients a day, cared for her 3-year-old daughter and ran long distances.

Today, her heart races when she tries to stand. She has severe headaches, constant nausea and brain fog so extreme that, she said, it “feels like I have dementia.” Her fatigue is severe: “It’s as if all the energy has been sucked from my soul and my bones.” She can’t stand for more than 10 minutes without feeling dizzy.

Through her own research, Dawson recognized she had typical symptoms of postural orthostatic tachycardia syndrome, or POTS. It is a disorder of the autonomic nervous system, which controls involuntary functions such as heart rate, blood pressure and vein contractions that assist blood flow.

It is a serious condition which affects many patients who have been confined to bed a long time with illnesses like covid as their nervous system readjusts to greater activity. POTS sometimes overlaps with autoimmune problems, which involve the immune system attacking healthy cells. Before covid, an estimated 3 million Americans had POTS.

Few Doctors Treat Autonomic Disorders

Many POTS patients report it took them years to even find a diagnosis. With her own suspected diagnosis in hand, Dawson soon discovered there were no specialists in autonomic disorders in Portland — in fact, there are only 75 board-certified autonomic disorder doctors in the U.S.

In January, Dawson called a neurologist at a Portland medical center where her father had worked and was given an appointment for September. She then called Stanford University Medical Center’s autonomic clinic in California, and again was offered an appointment nine months later.

Using contacts in the medical community, Dawson wrangled an appointment with the Portland neurologist within a week and was diagnosed with POTS and chronic fatigue syndrome (CFS). The two syndromes have overlapping symptoms, often including severe fatigue.

Dr. Peter Rowe of Johns Hopkins in Baltimore, a prominent researcher who has treated POTS and CFS patients for 25 years, said every doctor with expertise in POTS is seeing long-haul covid patients with POTS, and every long-covid patient he has seen with CFS also had POTS. He expects the lack of medical treatment to worsen.

“Decades of neglect of POTS and CFS have set us up to fail miserably,” said Rowe, one of the authors of a recent paper on CFS triggered by covid.

The prevalence of POTS was documented in an international survey of 3,762 long-covid patients, leading researchers to conclude that all covid patients who have rapid heartbeat, dizziness, brain fog or fatigue “should be screened for POTS.”

A “significant infusion of health care resources and a significant additional research investment” will be needed to address the growing caseload, the American Autonomic Society said in a recent statement.

Lauren Stiles, who founded the nonprofit Dysautonomia International in 2012 after being diagnosed with POTS, said patients who have suffered for decades worry about “the growth of people who need testing and treating but the lack of growth in doctors skilled in autonomic nervous system disorders.”

On the other hand, she hopes increasing awareness among physicians will at least get patients with dysautonomia diagnosed quickly, rather than years later. Dysautonomia International provides a list of a handful of clinics and about 150 U.S. doctors who have been recommended by patients.

Congress has allocated $1.5 billion to the National Institutes of Health over the next four years to study post-covid conditions. Requests for proposals have already been issued.

“There is hope that this miserable experience with covid will be valuable,” said Dr. David Goldstein, head of NIH’s Autonomic Medicine Section.

A unique opportunity for advances in treatment, he said, exists because researchers can study a large sample of people who got the same virus at roughly the same time, yet some recovered and some did not.

‘Huge Influx of Patients’

Long-term symptoms are common. A University of Washington study published in February in the Journal of the American Medical Association’s Network Open found that 27% of covid survivors ages 18-39 had persistent symptoms three to nine months after testing negative for covid. The percentage was slightly higher for middle-aged patients, and 43% for patients 65 and over.

The most common complaint: persistent fatigue. A Mayo Clinic study published last month found that 80% of long-haulers complained of fatigue and nearly half of “brain fog.” Less common symptoms are inflamed heart muscles, lung function abnormalities and acute kidney problems.

Larger studies remain to be conducted. However, “even if only a tiny percentage of the millions who contracted covid suffer long-term consequences,” said Rowe, “we’re talking a huge influx of patients, and we don’t have the clinical capacity to take care of them.”

Symptoms of autonomic dysfunction are showing up in patients who had mild, moderate or severe covid symptoms.

Yet even today, some physicians discount conditions like POTS and CFS, both much more common in women than men. With no biomarkers, these syndromes are sometimes considered psychological.

The experience of POTS patient Jaclyn Cinnamon, 31, is typical. She became ill in college 13 years ago. The Illinois resident, now on the patient advisory board of Dysautonomia International, saw dozens of doctors seeking an explanation for her racing heart, severe fatigue, frequent vomiting, fever and other symptoms.

For years, without results, she saw specialists in infectious disease, cardiology, allergies, rheumatoid arthritis, endocrinology and alternative medicine — and a psychiatrist, “because some doctors clearly thought I was simply a hysterical woman.”

It took three years for her to be diagnosed with POTS. The test is simple: Patients lie down for five minutes and have their blood pressure and heart rate taken. They then either stand or are tilted to 70-80 degrees and their vital signs are retaken. The heart rate of those with POTS will increase by at least 30 beats per minute, and often as much as 120 beats per minute within 10 minutes. POTS and CFS symptoms range from mild to debilitating.

The doctor who diagnosed Cinnamon told her he didn’t have the expertise to treat POTS. Nine years after the onset of the illness, she finally received treatment that alleviated her symptoms. Although there are no federally approved drugs for POTS or CFS, experienced physicians use a variety of medicines including fludrocortisone, commonly prescribed for Addison’s disease, that can improve symptoms.

Some patients are also helped by specialized physical therapy that first involves a therapist assisting with exercises while the patient is lying down, then later the use of machines that don’t require standing, such as rowing machines and recumbent exercise bicycles. Some recover over time; some do not.

Dawson said she can’t imagine the “darkness” experienced by patients who lack her access to a network of health care professionals. A retired endocrinologist urged her to have her adrenal function checked. Dawson discovered that her glands were barely producing cortisol, a hormone critical to vital body functions.

Medical progress, she added, is everyone’s best hope.

Stiles, whose organization funds research and provides physician and patient resources, is optimistic.

“Never in history has every major medical center in the world been studying the same disease at the same time with such urgency and collaboration,” she said. “I’m hoping we’ll understand covid and post-covid syndrome in record time.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Blood Pressure Meds May Help Treat Osteoarthritis

By Pat Anson, PNN Editor

People who suffer from osteoarthritis have few pain-relieving options outside of surgery and joint replacement. Opioids are usually not prescribed for osteoarthritis (OA) and over-the-counter drugs such as acetaminophen provide only mild relief or may have side effects if taken too often.

Some OA patients may have another treatment option already sitting in their medicine cabinets: blood pressure medication.

In a retrospective study, researchers at the University of Nottingham analyzed health data for over 223,000 people in the UK and found that patients taking two beta-blockers commonly prescribed for high blood pressure -- propranolol and atenolol -- made fewer trips to the doctor to be treated for knee and hip pain compared to those who don’t use the drugs. When patients stopped taking propranolol and atenolol, they had more office visits for joint pain.

The findings, recently published in the journal Rheumatology, suggest that beta-blockers have analgesic properties and may even slow the progression of osteoarthritis, a joint disorder that leads to thinning of cartilage in the knees, hips, fingers and spine. About 10% of men and 18% of women over age 60 have some form of osteoarthritis. .  

"Our findings suggest that atenolol could be considered for people with osteoarthritis and comorbidities for which beta blockers are indicated," co-authors Georgina Nakafero, PhD, and Abhishek Abhishek, PhD, said in a news release. "Similarly, propranolol may be a suitable analgesic for people with OA and comorbid anxiety.

"If these findings are confirmed in independent studies, and in a confirmatory randomized controlled trial, it may change clinical practice."

Previous research has suggested that beta-blockers have antinociceptive effects that help block pain signals. A 2017 study found the drugs lowered pain scores and reduced opioid use in 873 patients with OA. But a larger study failed to confirm those findings.

Two FDA advisory committees recently voted against recommending tanezumab, an experimental non-opioid pain reliever, as a treatment for osteoarthritis due to possible side effects. The agency has yet to make a final decision on the drug. If approved, tanezumab would be the first new class of medication for osteoarthritis in well over a decade.

Acetaminophen Use by Pregnant Women Raises Risk of Autism or ADHD in Children

By Pat Anson, PNN Editor 

A large new study in Europe is adding to the growing body of evidence that the use acetaminophen (paracetamol) by pregnant women raises the risk of their children having autism or Attention-Deficit Hyperactivity Disorder (ADHD)

Researchers at the University of Barcelona followed nearly 74,000 mothers and their children in the UK and five other European countries, finding that women who took the pain reliever while pregnant were 19% more likely to have children with Autism Spectrum Conditions (ASC) and 21% more likely to develop ADHD symptoms.

“Associations between prenatal acetaminophen and ASC and ADHD symptoms were consistently positive for both boys and girls albeit slightly stronger among boys,” researchers reported in the European Journal of Epidemiology.

Several previous studies have linked prenatal use of acetaminophen to autism, ADHD and hyperactivity in children, but this was by far the largest. Although the exact cause is unknown, it’s believed acetaminophen affects a baby’s brain development and growth, especially during the third trimester. The study found no evidence that acetaminophen raised the risk of autism and ADHD after the children were born.

Despite the findings, the UK’s National Health Service (NHS) maintains that it is safe for pregnant women to use paracetamol.

“Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the NHS says on its website.

The U.S. Food and Drug Administration also does not caution pregnant women about using acetaminophen. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

The University of Barcelona researchers are a bit more cautious, saying pregnant women should take acetaminophen “only when necessary.”

“Considering all evidences on acetaminophen use and neurodevelopment, we agree with previous recommendations indicating that while acetaminophen should not be suppressed in pregnant women or children, it should be used only when necessary,” they said.

Acetaminophen is the most popular pain reliever in the world, and is used by over half the pregnant women in Europe and the United States. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. Excessive use of acetaminophen can cause liver, kidney, heart and blood pressure problems. A recent study found little or no evidence to support its use for most pain conditions.  

FDA Approves First Drug for Both Migraine Treatment and Prevention

By Pat Anson, PNN Editor

Migraine sufferers have a new medication that not only treats migraines, but can also be used to help prevent them. Biohaven Pharmaceuticals announced this week that Nurtec (rimegepant) -- a drug already being used to treat migraine pain – has been approved by the FDA as a migraine preventative, making it the first migraine medication that can be used for both treatment and prevention.

Nurtec is a calcitonin gene-related peptide (CGRP) inhibitor, a relatively new class of medication that blocks a protein released during migraine attacks from binding to nerve receptors in the brain. Since 2018, the FDA has approved a handful of CGRP medications, most which are taken by injection.

Nurtec is a quick-dissolving tablet that is taken orally. A single dose can treat migraine pain for up to 48 hours. The expanded FDA approval means Nurtec can now also be taken daily or every other day to help reduce the frequency of migraines. 

“The FDA approval of Nurtec ODT for the preventive treatment of migraine -- along with its acute treatment indication -- is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine. To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine," said Peter Goadsby, MD, a Professor of Neurology at the University of California, Los Angeles.

Goadsby was one of the investigators in a Phase 3 study that helped prove Nurtec can be used as a migraine preventive. In findings recently published in The Lancet, Nurtec reduced the number of migraine days per month by 30% after one week of treatment. After three months of treatment, about half of the patients taking Nurtec had at least a 50% reduction in the number of moderate-to-severe migraine days per month.

Nurtec was well-tolerated by most patients during the clinical trial. Some reported nausea, stomach pain and indigestion.

"This FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks,” Biohaven CEO Vlad Coric, MD, said in a statement. “This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy.”

One obstacle to using Nurtec is its cost. Currently, a single 75mg tablet is priced at about $117. A supply of eight tablets is around $941, depending on your insurance coverage and pharmacy.  Biohaven has a patient assistance program that can help some patients who lack insurance or can’t afford the drug.

A recent survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication. About 11 percent said they were using a CGRP to treat migraine pain. Patients who did not try the drugs said they were concerned about side effects, long-term safety and their cost.

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

Overdose Crisis Linked to Poor Mental Health

By Pat Anson, PNN Editor

A comprehensive new study has found that stress and anxiety are key drivers in the U.S. overdose crisis, with poor mental health increasing the risk of dying from a drug overdose by as much as 39 percent.

"We saw a strong association with mental health and substance abuse disorders, particularly opiates," says co-author Diego Cuadros, PhD, an epidemiologist who directs the University of Cincinnati’s Health Geography and Disease Modeling Laboratory. "What's happening now is we're more than a year into a pandemic. Mental health has deteriorated for the entire population, which means we'll see a surge in opiate overdoses."

Cuadros and his colleagues looked at overdose deaths and socioeconomic data in the U.S. from 2005 to 2017, and identified 25 “hot spots” or sub-epidemics where there was a sizeable increase in drug deaths. In the Southwest, sub-epidemics were driven by methamphetamine and heroin, while overdoses in the Northeast and Midwest were first fueled by heroin, then prescription opioids, and now synthetic opioids such as illicit fentanyl.

U.S. Overdose “Hot Spots”

PLOS ONE

While different substances were often involved in sub-epidemics, researchers say the one thing they all had in common was high levels of physical and mental distress.

"This is a complex epidemic. For HIV we have one virus or agent. Same with malaria. Same with COVID-19. It's a virus," Cuadros said. "But with opioids, we have several agents. At the beginning of the epidemic it was heroin. By 2010 it switched to prescription opiates."

Deaths of Despair

The study, published in PLOS ONE, builds on the so-called “deaths of despair” theory that was first described in 2015 by Princeton researchers Anne Case and Angus Deaton, who found that the reduced life expectancy of middle-aged white Americans was linked to substance abuse, unemployment, limited education, divorce, depression and loss of social connections.

The new study found that young white males aged 25 to 29 were most at risk of a fatal opioid overdose, followed by white males aged 30 to 34. In recent years, they were joined by black males aged 30 to 34 who also have an elevated risk of dying from an overdose. Those age groups do not fit the typical profile of a pain patient on prescription opioids, who is usually older and has an age-related disability such as arthritis.

“For the past 20 years, seniors over age 62 have had the highest rates of doctor-prescribed opioid pain relievers, while sustaining the lowest and mostly stable rates of opioid overdose related mortality. During the same period, overdose mortality more than tripled among adults age 25 to 34, who receive far fewer prescriptions than seniors,” says Richard “Red” Lawhern, PhD, a patient advocate who has long argued that the demographics of the overdose crisis prove it is not being driven by opioid medication. 

“Drug abuse and addiction are instead driven by complex socio-economic factors that some investigators have called ‘a crisis of hopelessness.’ Structural unemployment and poverty have rendered some populations more vulnerable to drug abuse than others,” said Lawhern.

“Hot spots of high mortality occur primarily in rural counties of the Rust Belt, deep South and West, with a sprinkling in inner cities also paralyzed by poverty. Communities are being hollowed out and families are failing due to a national failure to invest to replace infrastructure and mining jobs formerly held by high school educated men.”   

A notable holdout in the “deaths of despair” theory is Andrew Kolodny, MD, an addiction treatment specialist and longtime critic of opioid prescribing who is the founder of the newly renamed Health Professionals for Responsible Opioid Prescribing (PROP).

“The vast majority of drug overdose deaths are occurring in people with the disease of opioid addiction, not necessarily people who are drinking or using drugs driven by socioeconomic factors,” said Kolodny in a recent webinar. “The deaths of despair framing, while provocative, is unlikely to explain the main sources of the fatal drug epidemic and that efforts to improve economic conditions in distressed locations, while desirable for other reasons, are not likely to yield significant reductions in drug mortality.”

Kolodny is not an economist, epidemiologist or pain management specialist. He is a well-paid expert witness in opioid litigation cases – lawsuits that depend on a public narrative that excess opioid prescribing, not mental health problems, led to the addiction and overdose crisis. Maintaining that narrative is becoming harder, with opioid prescribing in the U.S. at 20-year lows and overdose deaths at record highs, fueled in part by economic and social issues exacerbated by the pandemic.

In other comments during the webinar, Kolodny said the CDC’s 2016 opioid guideline was “a bit wishy washy” because it only said that opioids were not the preferred treatment for chronic pain. Kolodny said a Department of Veterans Affairs and Department of Defense guideline that came out a year later was “a lot better” because it advised doctors not to begin long-term opioid therapy on any new patients.    

Instead of opioids, the DOD guideline recommends exercise, yoga and cognitive behavioral therapy to treat chronic pain, along with non-opioid drugs such as gabapentin.

Cannabis Poisoning Calls Rise, Particularly for Children

By Pat Anson, PNN Editor

A new analysis of calls to U.S. poison control centers suggests that more regulation is needed of cannabis products to protect consumers – and children in particular — from adverse health consequences.

Researchers found a significant increase in cannabis-related calls to poison centers from 2017 to 2019, about half of them from a healthcare facility.

Most of the 28,630 calls involved someone ingesting cannabis flower or buds, but a growing number involved manufactured cannabis products such as edibles, vaporized liquids and concentrates. About a third of the calls were considered serious.

Cannabis-Related Calls to U.S. Poison Control Centers

JAMA NETWORK OPEN

Most of the calls about manufactured cannabis products involved underage children. Twenty-seven percent involved children under the age of 10 and about a third (34.5%) involved youths between 10 and 20 years of age. Edibles were involved in about two-thirds of those calls.

“Children may be at particular risk for exposure to edible products, such as cookies or candy,” wrote lead author Julia Dilley, PhD, Oregon Health Authority, in JAMA Network Open.

“Although we did not see more serious health outcomes for manufactured product exposures compared with plant products overall, most cannabis plant exposures involved polysubstance use, whereas most cases for manufactured products were for those products alone, suggesting that exposure to manufactured products alone may be relatively more likely to generate adverse events.”

Dilley and her colleagues say cannabis products are riskier for children because they may not know they are consuming THC (tetrahydrocannabinol), the psychoactive ingredient in cannabis. Even when they are labeled, research has found that the amount of THC in cannabis products is often inaccurate.

The study did not distinguish between medical and recreational cannabis. Interestingly, the rate of calls to poison centers from states where cannabis is legal was slightly higher than those where cannabis is still illegal, suggesting that legalization does not increase the level of safety.  

“Market factors may drive the industry to continue developing novel products, which could present additional health risks. Applying regulatory controls to market-driven innovations in potency and additives is key. Novice cannabis users are often advised to ‘start low, go slow’; this guidance may be equally applicable to regulating new retail cannabis markets and products,” researchers said.

Some cannabis companies are intentionally marketing their products as candy and snacks to make them more attractive to children. The Food & Wine website reports the Wrigley Company recently filed three lawsuits against cannabis manufacturers, alleging they produced THC-spiked products that resemble Wrigley candies such as Skittles, Life Savers and Starbursts   

“We take great pride in making fun treats that parents can trust giving to their children and children can enjoy safely," a Wrigley spokesperson told Reuters. "We are deeply disturbed to see our trademarked brands being used illegally to sell THC-infused products."

One cannabis company, THC Living, recently took a “snortable” cannabis candy off the market after complaints on social media. According to Leafly, the packaging and marketing of “Cannabis Bumps” were designed to make the powdered candy look like cocaine. Each package contained a hefty dose of 600mg of THC.    

How Opioid Hysteria Affects Cancer Patients

By Pat Anson, PNN Editor

Over the years, we’ve received many complaints from cancer patients about their pain being poorly treated or even left untreated. Although the CDC’s opioid guideline specifically says it is “not intended for patients undergoing active cancer treatment,” some doctors take the recommendations so seriously they won’t prescribe opioids to cancer patients, fearing it could lead to abuse and addiction.

“Just last week my 90-year-old mother, who is a cancer patient going through chemo, was accused of having opioid use disorder when she went to the emergency room with a painful bacterial infection. She was left with no pain relief, even though she is a compliant patient with no history of abuse,” one reader told PNN.

“I suffer from severe stage 4 cancer pain that has gotten worse and worse and may be terminal. Despite my increasing pain, no one will increase my dosages directly due to the CDC,” another reader told us.

“I have struggled to find a doctor to treat my pain,” a patient with terminal stage 4 lung cancer said. “I am in total shock that cancer patients have to suffer like this. These guidelines have terrified doctors. If they’re too scared to treat cancer pain, what pain will they treat?”

After hearing stories like those, it was startling to read the results of a small study in the journal Cancer that found some cancer patients were so traumatized by opioid hysteria they were reluctant to take opioids because of the stigma associated with their use. Researchers at the Dana-Faber Cancer Institute in Boston interviewed 26 patients with advanced cancer and found that many were fearful of using opioids — even though the risk of opioid addiction and overdose is low for cancer patients.

“Patients consistently described the negative impact of the opioid epidemic on their ability to self-manage pain. Negative media coverage and personal experiences with the epidemic promoted stigma, fear, and guilt surrounding opioid use. As a result, many patients delayed initiating opioids and often viewed their decision to take opioids as a moral failure,” wrote lead author Desiree Azizoddin, PsyD.

“Patients frequently managed this internal conflict through opioid-restricting behaviors (eg, skipping or taking lower doses). Stigma also impeded patient-clinician communication; patients often avoided discussing opioids or purposely conveyed underusing them to avoid being labeled a ‘pill seeker.’”

Adding to the stigma, researchers said several patients ran into “logistical complications” with pharmacies and insurers when they tried to get an opioid prescription filled.

“Patients experienced structural barriers to obtaining opioids such as prior authorizations, delays in refills, or being questioned by pharmacists about their opioid use. Barriers were stressful, amplified stigma, interfered with pain control, and reinforced ambivalence about opioids,” they said.

Reports of opioid hysteria affecting cancer care are not new. In 2019, the Cancer Action Network said there was “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.”

That same year, the CDC issued a long-awaited acknowledgement that the “misapplication” of the 2016 guideline had been harmful to pain patients, including those being treated for cancer. The agency said it would evaluate the impact of the guideline and make changes “when new evidence is available.”   

Five years after the guideline’s release, cancer patients are still waiting for those changes to be made.

“I had breast cancer twice and suffer severe chest wall and referred pain from surgery and radiation treatments, plus severe spine damage, but have been denied pain treatment. This has become a crime against humanity which would never be allowed in any other country,” a cancer survivor told us.

The Trouble With Pain Treatment Guidelines

By Donna Gregory Burch

I'm trying to figure out why certain medical organizations think they know more about treating my chronic pain than my actual doctors. It seems every single one of these groups shares the same opinion: Opioids are bad. Antidepressants, exercise and meditation are good.

That's the takeaway from new treatment guidelines for fibromyalgia and other forms of “chronic primary pain” released by the European Pain Federation and the UK’s National Institute for Health and Care Excellence (NICE). Both sets of recommendations are on trend with the opioid prescribing guideline adopted by the U.S. Centers for Disease Control and Prevention (CDC) in 2016.

The European Pain Federation recommends against using opioids to treat fibromyalgia, low back pain, irritable bowel syndrome and other forms of chronic primary pain for which there is no known cause. Opioids can be used for certain types of “secondary” pain caused by surgery, trauma, disease or nerve damage, according to the federation, but only when other treatments such as exercise, meditation and non-opioid medications have failed.

The NICE guidelines are even stricter, advising physicians not to prescribe any kind of painkiller to those with fibromyalgia, chronic headache, chronic musculoskeletal pain and other chronic primary conditions. That includes non-opioid painkillers like paracetamol (acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids (gabapentin, pregabalin), corticosteroids (prednisone, prednisolone) and benzodiazepines (Valium, Xanax).

As someone who lives with fibromyalgia, chronic lower back pain and chronic daily headaches, I thank God that I don't live across the pond, as they say. Frankly, I'd probably throw myself off a bridge if my doctors adhered to either of these guidelines.

And no, I'm not being overdramatic. I'm sure I speak for many of the readers here at Pain News Network and my own website, Fed Up With Fatigue, when I express alarm over how authoritarian and inhumane these guidelines aimed at chronic pain patients are becoming.

Of course, things aren't much better on U.S. soil. Physicians here are still running scared due to the CDC's opioid guideline. It's becoming increasingly difficult to find doctors who will prescribe opioids or even accept a patient who is already on opioids. It matters little if the patient has been using them responsibly for years or even decades.

A ‘Little Bit of Life’ Gone

A couple of weeks ago, one of my readers shared that she used to be able to work and manage her home when her opioid dosage was at a certain level. But then the CDC decided to stick its nose into her personal health journey by recommending that general practitioners should not prescribe opioids to patients with fibromyalgia.

Her doctor saw those recommendations and cut her dosage. Now, she's basically homebound. The little bit of life that she had as a chronic pain patient is no longer.

How is this fair? Or humane?

It isn't.

And why is she being punished because a small number of opioid users were irresponsible and became addicted? That is not the fault of the millions of opioid users who do use them responsibly!

It's easy for “experts” and regulators to condemn opioids when they're not the ones in pain. And it's a slap in the face to have them tell me I should take ibuprofen for a migraine, or worse yet, to go take a walk.

Obviously, they haven't experienced the headaches that I have - one of which was so bad that I curled up in a ball on the sofa and whispered to my husband through tears, "I just want to die."

And yes, it really was that bad! To suggest that doing some deep breathing or talking with a counselor is going to help that level of pain is completely asinine.

Opioids and Fibromyalgia

But I think what pisses me off the most is that these government agencies and medical organizations constantly say over and over and over again that opioids don't work for fibromyalgia. There's no way they actually took the time to review the existing research, because if they had they would know that statement is based on opinion, not fact.

The truth is very few research trials have actually studied if opioids are an effective treatment for fibromyalgia. In 2016, I took a deep dive into the research on using opioids for fibromyalgia and was stunned by just how little data there really is.

In 2011 and 2013, there were a couple of large studies at McGill University in Montreal, Canada, involving around 300 fibromyalgia patients who were being treated with opioids. The researchers concluded "opioid-treated patients were more symptomatic and were more likely to be unemployed and to be receiving disability benefits."

The inference from that statement is that somehow the opioids increased the patients' symptoms when there's no way to know for sure if that's what really happened. It's entirely possible those patients were on opioids because their symptoms were more severe, which would also explain why those particular patients were more likely to be unemployed and on disability.

You'd think these researchers would remember a simple principle that many of us learned in college: Correlation doesn't equal causation.

Then, there have been at least three studies (2000, 2003 and 2011) that looked at the effectiveness of tramadol, a weaker synthetic opioid, at reducing fibromyalgia pain. All of these studies confirmed tramadol improved fibro-related pain.

A small Swedish study from 1995 found intravenous morphine did not improve fibromyalgia pain, and a 2003 study from the University of Cincinnati College of Medicine concluded opioids were not effective.

I might have missed a small trial here and there, but that's basically the gist of the research that has studied the use of opioids for fibromyalgia. Little has changed since I reviewed the research five years ago. There still haven't been any large trials testing the efficacy of opioids in fibro patients.

So looking at the scant research that's available, how can the people who develop these treatment guidelines honestly say opioids don't work for fibromyalgia patients? They can't.

As the saying goes, "absence of evidence is not evidence of absence." In other words, you can't say opioids don't work when you've never even taken the time to study whether opioids help fibromyalgia pain or not.

And it is disingenuous to suggest otherwise.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpWithFatigue.com. You can also find her on Facebook, Twitter and Pinterest. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania.

FDA Seizes 37 Tons of Kratom in Florida

By Pat Anson, PNN Editor

The Food and Drug Administration has announced a large seizure of kratom from a supplement packaging company in Florida, in what could be an escalation of the agency’s efforts to stop kratom sales in the United States.

Over 37 tons of kratom powder and over 200,000 units of dietary supplements containing kratom were seized earlier this month by U.S. Marshals at an Atofill warehouse in Fort Myers, FL. The company imports kratom from Indonesia and resells it in capsules and powder under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo. The seized products are worth about $1.3 million, according to the FDA.

In April, Atofil and dozens of other kratom exporters and importers were named by the FDA in an updated import alert which gives the agency broad powers to seize shipments of kratom. In a statement on Twitter, acting FDA Commissioner Janet Woodcock, MD, compared kratom to morphine.

“To protect the public health, the FDA will continue to take action against kratom-containing dietary supplements,” Woodocok said. “Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Kratom affects the same opioid brain receptors as morphine & appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence.”

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. A recent study estimated that about two million Americans use kratom to self-treat their chronic pain, anxiety, depression and addiction.

Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement. During an FDA inspection of Atofil earlier this year, investigators observed large quantities of kratom powder and capsules labeled as “herbal supplements.” In the eyes of the FDA, that is a violation of federal law that prohibits the sale of adulterated dietary supplements.

The U.S. Department of Justice, working on behalf of the FDA, filed a civil complaint against Atofil in federal court, alleging that kratom is a new dietary ingredient for which there is no adequate information on its potential risk to human health.

Mac Haddow, a lobbyist for the American Kratom Association, told PNN the court action and seizure amounted to “an end-around of the Controlled Substances Act” by the FDA and was “a pretty big expansion of their authority.”

‘Embarrassingly Poor Evidence’

A DEA effort to ban kratom in 2016 failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew its request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat.

Former FDA Commissioner Scott Gottlieb, MD, who regularly campaigned against kratom while heading the agency, says more action needs to be taken by the Biden administration.

“We were prevented by HHS from moving forward with the scheduling of Kratom, and I’m convinced it’s fueling the opioid addiction crisis. The Biden Administration should follow through on efforts of FDA, NIH, and DEA — and the new ASH should affirm health findings of these agencies,” Gottlieb said on Twitter, referring to Rachel Levine, MD, Asst. Secretary for Health at HHS.

Gottlieb’s tweet brought a rebuke from Brett Giroir, MD, a former four-star admiral in the U.S. Public Health Service and Asst. Secretary for Health in the Trump administration. It was Girior who wrote a 2018 letter to the DEA notifying the agency that HHS was withdrawing its request to schedule kratom.

“FDA doesn't schedule; it only recommends. FDA's recommendation was rejected b/c of embarrassingly poor evidence & data, and a failure to consider overall public health. If #Kratom is fueling opioid addiction, prove it; and then @HHS_ASH should reconsider,” Giroir tweeted.

Gottlieb responded with yet another tweet, claiming that “public health suffered” as a result of Girior’s action.

“It’s true: Brett Giroir unilaterally overruled a considered, multi year, scientific effort by the NIH, FDA, and DEA and a careful analysis in an act I found hasty and ill conceived,” said Gottlieb.

A 2020 study funded by the National Institute on Drug Abuse — which is part of the the NIH — concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Pilot Study Shows Stem Cells Effective in Treating Shoulder Pain

By Pat Anson, PNN Editor

A single injection of stem cells has shown promise as a treatment for shoulder pain caused by rotator cuff disease, according to the results of a small pilot study conducted by the Kessler Foundation.

Ten wheelchair users with moderate to severe shoulder pain received an injection of adipose stem cells derived from their own fat tissue. The participants all had spinal cord injuries and chronic shoulder pain for at least six months that did not respond to conventional treatment.   

The stem cells were micro-fragmented using minimal manipulation to preserve fat clusters and the cells’ regenerative properties. This micro-fragmented adipose tissue (MFAT) was then injected into shoulder tendons under ultrasound guidance.

The study findings, recently published in the Journal of Spinal Cord Medicine, showed nearly 80 percent of participants had a significant decrease in pain symptoms, and all but one reported improvement in pain and function. Symptoms steadily improved over the course of a year, suggesting the injections have long-lasting effects. There were no significant adverse events.

"These results show that the minimally invasive injection of micro-fragmented adipose tissue is a safe and efficacious option for wheelchair users with shoulder pain caused by rotator cuff disease," said Gerard Malanga, MD, a founder of the New Jersey Regenerative Institute and a visiting scientist at the Kessler Foundation.

“We feel there is great potential for this therapy to help people with shoulder pain manage their symptoms and improve their quality of life.”

In addition to their regenerative properties, MFAT stem cells are believed to provide cushioning and to fill-in structural defects when injected into damaged shoulder joints.

Malanga and his colleagues are currently conducting a larger Phase 2 controlled study with 24 participants that will compare MFAT injections to corticosteroid injections for treating pain caused by rotator cuff disease or tears.        

Shoulder pain is a common occurrence among wheelchair users with spinal cord injuries because they rely solely on their upper limbs to perform everyday tasks. The pain is often caused by soft-tissue injuries such as inflamed rotator cuff tendons. Pain medication and physical therapy are typically used to treat shoulder pain, with surgery as a last resort – not a good option for someone with a spinal cord injury.

The New Jersey-based Kessler Foundation is a global leader in rehabilitation research and employment programs for people with neurological disabilities caused by diseases and injuries of the brain and spinal cord.