Did Pacira Lie to Investors or a Federal Judge?

By Pat Anson, PNN Editor

The war of words between Pacira BioSciences and the American Society of Anesthesiologists (ASA) continues to escalate, with new allegations that the drug company either lied to its investors or a federal judge.

New Jersey-based Pacira filed a lawsuit in April over three articles in the ASA journal Anesthesiology that disparaged Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain. An editorial and two peer-reviewed research articles said Exparel worked no better than other bupivacaine products, even though it costs 10 times more.

Pacira filed a libel complaint against the ASA in federal court seeking a retraction and damages for “significant pecuniary harm.” The company said “multiple existing customers” had either stopped using Exparel or were considering it because of the journal articles.

If true, that would be a significant blow to Pacira, since Exparel accounted for 96% of the company’s revenues in 2020.

The ASA filed a motion last week asking a federal judge to dismiss the case, calling the lawsuit “an egregious and unjustified public relations campaign that seeks to chill scientific research and debate.”

‘Nothing to Worry About’

The ASA motion quotes a statement from a May 4 earnings call, in which Pacira CFO Charlie Reinhart told analysts that “we don’t have anything to worry about” and “actually things are going very, very well,” despite the negative reviews of Exparel in the medical journal.

In a preliminary report released last week, Pacira even boasted about sales of the drug. “Exparel sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales,” the company said in a statement that didn’t mention the lawsuit.

“In other words, Pacira is lying either to a federal judge or its investors,” the ASA said in a press release Monday.  

A Pacira spokesperson declined to respond to the ASA statement, telling PNN that “our corporate policy is not to comment on pending litigation.”

Exparel was first approved by the FDA in 2011 as a local anesthetic for post-operative pain in adults.  Its use has since been expanded to include children and as a nerve blocking agent.  Pacira says over 8 million patients have been treated with Exparel. The drug is primarily sold to hospitals and ambulatory surgical centers. One of the biggest purchasers is the U.S. Department of Defense.

In the past, Pacira has gone to great lengths to promote Exparel and silence critics.  In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. In 2020, Pacira agreed to pay $3.5 million to resolve allegations that it gave kickbacks to doctors to promote Exparel in research articles.

Chronic Pain Runs in My Family

By Victoria Reed, PNN Columnist

While I was growing up, I knew my mother used a lot of over-the-counter pain relievers. At the time, I didn’t think much of it. As a child, I didn’t view my mother as sick, especially since she rarely went to doctors.

I knew she had a history of major back surgery, and besides being frequently tired and living with sore muscles and a lack of sleep, she seemed to just carry on without the help of doctors.

Now as I look back and take a closer look into the past, I believe my mother suffered from the same or similar chronic pain conditions as I do: degenerative disk disease, fibromyalgia and possibly rheumatoid arthritis.

Two of my sisters also suffer from degenerative disk disease, fibromyalgia, RA and lupus. My brother had severe scoliosis and longstanding chronic back pain. He lived most of his life in pain and died at a relatively young age. In addition, a maternal aunt had chronic pain from multiple sclerosis and eventually died from the disease.

I often wondered if there was anything I did to earn my many diagnoses, but knowing my family’s history has answered that question for me. Studies show that some chronic pain conditions and autoimmune conditions do, indeed, have a genetic origin. This genetic predisposition can be activated by something in the environment, such as a virus, and subsequently could trigger the onset of an illness.

When one of my sons was 6-years old, a respiratory virus caused his immune system to attack his kidneys, resulting in renal failure. He had glomerulonephritis, a condition where the kidneys’ filters become inflamed and scarred. The result is that waste products build up in the blood and body. He had only 15% of his kidney function remaining at the time of diagnosis.

Unfortunately, my son received three misdiagnoses in the two weeks prior to receiving the correct one! Being a fierce advocate for him and knowing with a mother’s intuition that something was seriously wrong, I pushed for doctors to not dismiss his symptoms and look deeper for the problem, as he had begun to swell up. Without proper treatment, he could have ended up on dialysis, the kidney transplant list or suffered from chronic kidney disease for the rest of his life.

Fortunately, after finally getting an accurate diagnosis and quality in-patient supportive care, he began to recover. Today he is a healthy, active 19-year-old with no residual kidney problems.

My 16-year-old daughter has also been diagnosed with fibromyalgia. She suffers from muscle pain, soreness and severe fatigue. I have seen doctors unwilling to take her complaints seriously and unwilling to treat her with anything.

Furthermore, one of my sons also has scoliosis, and having seen what my brother experienced, his future concerns me as well. Many people with scoliosis suffer from back pain throughout their lives.

I am concerned about what my children’s futures may look like, in light of the difficulties that many chronic pain patients face today. As a mom, I will continue to advocate for my daughter’s care and encourage her to advocate for herself as she grows up. It is my hope that compassion and willingness to treat patients properly will return to the specialty of pain management. Parents should not have to fear that their children will be allowed to suffer.

I’m sure that my family is not unique. Families with multiple chronic pain conditions should rally together for support, understanding and most importantly, adequate pain care!

My sisters and I often compare notes and discuss our various treatments. We support each other through our toughest days, and just having that emotional support from each other makes a world of difference. However, many in our chronic pain community do not have that kind of support and are either not believed or taken seriously. Support groups can be very useful in these situations, and I have found that they are helpful. Being a part of a support group assures me that I am not alone in my struggles.

I encourage anyone who feels alone to reach out to someone or join a support group. With social media, it’s now easier than ever to be connected with people when there is no family support.

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

Medical Cannabis No Help to Lobsters

By Pat Anson, PNN Editor

Do lobsters feel pain when they’re boiled alive?

Seafood lovers, cooks, academics, animal rights activists and even governments have debated that question for years, with the general consensus being that they do. Lobsters, crabs and other crustaceans will often writhe in pain and try to escape when dropped into a pot of scalding hot water. The practice is considered so cruel that Switzerland and New Zealand made it illegal to boil a live lobster.

Some cooks try to ease the lobsters’ pain by stunning them with a jolt of electricity or putting them on ice to dull their senses before cooking them.  In 2018, a restaurant owner in Maine even blew marijuana smoke on a lobster named Roscoe, who reportedly grew so mellow he never wielded his claws as weapons again while in captivity.

We’ll never know the long-term effect of getting a lobster stoned because Roscoe was returned to the ocean as a thank you for his service. Good for him.

Which brings us to a bizarre study recently completed by scientists at the University of California San Diego and the Scripps Research Institute, who decided to replicate the Roscoe experiment in a lab.

"The 2018 minor media storm about a restaurant owner proposing to expose lobsters to cannabis smoke really was the starting point. There were several testable claims made and I realized we could test those claims. So we did," lead author Michael Taffe, PhD, an adjunct professor at Scripps Research told IFLScience.

Taffe and his colleagues purchased ten Maine lobsters at a local supermarket, fed them a last meal of frozen krill and fish flakes, and placed them in an aerated vapor chamber.

For the next 30 to 60 minutes, the lobsters were exposed to vapor rich in tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis.

Afterwards, some of the lobsters were “rapidly euthanized” with a kitchen shear and dissected, while others were immersed in hot water to see how they’d react.

bioRxiv

Detectable levels of THC were found in the muscles and organs of the euthanized lobsters, so from that standpoint the experiment was a success. But the THC apparently had little effect on the remaining live lobsters, who displayed “distinct motor responses” and other signs of pain when put in hot water.   

"The effect of vapor THC on this nociceptive (pain) behavior was very minimal. Statistically supported in one case, but of very small magnitude," said Taffe.

We’ll leave it to readers to decide whether a study like this is humane, worthwhile or even makes sense. But it is worth noting that taxpayers helped pay for it.

The lobster cannabis study was supported by grants from the U.S. Public Health Service. Researchers were careful to note that federal funding was not directly used to purchase the lobsters. That money came from La Jolla Alcohol Research, a private company that is developing vapor inhalation technologies.  According to GovTribe, La Jolla Alcohol Research has received about $3 million in federal funding in recent years, most of it coming from the National Institute on Drug Abuse.

Did CDC Opioid Guideline Have ‘Unexpected Benefit’ for Surgery Patients?

By Pat Anson, PNN Editor

Since its release in 2016, the CDC’s opioid prescribing guideline has had a sweeping impact on pain management in the United States. Although only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioids have been widely adopted by states, insurers, pharmacies, hospitals and doctors treating all types of pain.

A new study published in JAMA Network Open documents how opioid prescribing for post-operative acute pain fell significantly in the first two years after the guideline’s release.      

Researchers looked at prescribing data for over 360,000 patients who had 8 common surgical procedures and found that the amount of opioids initially prescribed after surgery fell by an average of 16 percent. The decline for each patient was the equivalent 11 oxycodone 5mg tablets.  

“This study has important policy and practice implications. Although the primary focus of the 2016 CDC guideline was on opioid prescribing for chronic pain, our findings suggest that the guideline was associated with clinically relevant changes in patterns of opioid prescribing after surgery,” wrote lead author Tori Sutherland, MD, a Professor of Anesthesiology at the Perelman School of Medicine, University of Pennsylvania.

The study didn’t look at what alternatives surgery patients were given for pain management or whether they were satisfied with their pain relief. But because refill rates were unchanged after the guideline’s release, Sutherland and her colleagues concluded that “it is unlikely that guideline misapplication led to significant opioid underprescribing for surgical pain.”

An editorial also published in JAMA Network Open called the decline in opioid prescribing for post-operative pain “a promising trend” and said further cuts were needed to reduce the number of leftover pills.

“The 2016 CDC guideline for chronic pain may have provided an unexpected benefit to surgical patients by accelerating the alignment of opioid prescribing with amounts recommended in surgery-specific prescribing guidelines. Nonetheless, much room for improvement remains,” wrote lead author Mark Bicket, MD, an anesthesiologist at the University of Michigan School of Medicine.

“We have known for a long time that the average patient has been prescribed nearly twice as much opioid as they need, or will use, following surgery,” said Dr. Lynn Webster, a PNN columnist and pain management expert. “This unused medication has been a major source of diverted opioids that have contributed to the national illicit drug use problem. In this regard, their observation does suggest fewer drugs are available for diversion. That is a good thing.

“However, mean data does not take into account an individual’s need. Some patients need more medication than other patients for the same surgical procedure. It is unhelpful to use dose reduction as a measure of improved care. We should focus on using the appropriate amount of opioids for the appropriate length of time to achieve improved prescribing.”

Webster said it was speculative to suggest that the CDC guideline had an “unexpected benefit” for surgery patients. The best measure is whether overdose deaths are decreasing – and by that standard the guideline has been a failure. Five years after its release, opioid prescribing is at 20-year lows while overdose deaths are at record highs, fueled largely by illicit fentanyl and other street drugs.

“Cleary, the decline in opioids prescribed for post-op pain has not improved that outcome which is, arguably, the most important outcome to measure,” said Webster.

Opioid addiction is actually rare after surgery.  A large 2016 study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in 2018 found only 0.6% of patients who took opioids for post-operative pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Rare Disease Spotlight: Dupuytren’s Contracture

By Barby Ingle, PNN Columnist 

This month’s rare disease spotlight looks at a painful hand deformity called Dupuytren’s contracture. My father had this condition and I know two other men who have it; one white and one Hispanic. It is most common in older men of Northern European descent, which is why it is known as the “Viking disease.” It occurs in about 5 percent of people in the United States.

Dupuytren’s contracture usually affects the ring and “pinky” fingers, making it difficult to completely straighten them or pick up objects. It develops over time when knots of tissue form under the skin, creating a think cord that can pull one or more fingers into a bended position. Only rarely are the thumb and index finger affected. Dupuytren's can occur in both hands, though one hand is usually affected more severely.

Doctors don’t know what causes Dupuytren's and there is no evidence that hand injuries or occupations that involve the hands contribute to it. My father used to say his condition developed from playing football and getting his fingers smashed between the pads of other players. Interestingly, former NFL quarterback John Elway has Dupuytren’s and recently began appearing in TV commercials promoting a non-surgical treatment.

Dupuytren’s can be very frustrating for those trying to do everyday actives like putting your hands in your pockets, putting on a glove or just shaking hands. As it progresses, the skin on your palm might appear puckered or dimpled. A firm lump of tissue can form on your palm that is sensitive to touch.

I had similar symptoms for several years, but for a very different reason. My right hand and foot curled up due to Reflex Sympathetic Dystrophy (RSD). My symptoms improved after I began infusion therapy in 2009, but my fingers remain affected and the lump in my palm is still sensitive.  

My dad’s fingers were so bent up, he had surgery to straighten them. They just curled up again and never functioned well, before or after surgery. This is known as treatment-resistant Dupuytren’s. There is no way to know if you have a treatment resistant version until surgery is tried.  

Dupuytren's contracture occurs most commonly in men over the age of 50. Men are also more likely to have severe symptoms than women. The condition tends to run in families so there may be a genetic component that has yet to be confirmed. If you are the first in your family to get it, it’s possible that tobacco and alcohol use may contribute to it developing. My dad had diabetes II, which is also a risk factor, although he had Dupuytren's prior to being diabetic.

For those with mild forms of this condition, you can do a few things to help slow its progress. Start with avoiding projects with tight grip requirements, like mechanical work with small tools, or use padding on your hands to protect them.

In some cases, Dupuytren's does not progress or does so slowly. But if treatment is needed, it may involve surgically removing or breaking apart the cords that are pulling your fingers toward your palm. The choice of procedure depends on the severity of your symptoms and other health problems you may have.

There is a procedure less invasive than surgery where a needle is inserted through your skin. If contractures recur, the procedure can be repeated. This option requires little to no physical therapy, but can damage nerves or tendons in your hand.

There is also a medication, called Collagenase Clostridium Histolyticum, which can be injected into your hand so the provider can try to break up the cord and straighten your fingers. The injections are not widely offered and have similar drawbacks to the needling option.

My father chose surgery because his condition was advanced and he had limited use of his hand.  His provider surgically removed the tissue in his palm that was affected by the disease and closed it up with a skin graft. The results were mixed. For a few years, my father could open his hand and spread some of his fingers, but he did not get total strength or movement back and it progressively worsened as he aged. He also had physical therapy while recovering from the surgery, which took about 6 months for him. He said it was worth the try.

If you are looking for a Dupuytren's resource center and support group, one of the better ones I found is run by University of California, San Francisco. They provide a variety of services, including social workers and condition-specific support groups, as well as classes to help patients and their families.

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.

Why Good Nutrition Is Needed for Intractable Pain Syndrome

By Forest Tennant, PNN Columnist

If you have Intractable Pain Syndrome (IPS) or a condition that commonly causes IPS, such as arachnoiditis, adhesive arachnoiditis, cauda equina syndrome, Ehlers-Danlos Syndrome, traumatic brain injury, stroke or Complex Regional Pain Syndrome (CRPS), you should underpin your treatment program with a nutritional one.

Our research and experience clearly tell us that a proper nutrition program is essential for pain relief and to prevent the progression of IPS. Without a good nutritional program, neither medication or other medical measures will be very effective.

Persons who have IPS develop what is known as a “catabolic state.” The term means that the cellular matrix of the body is slowly degenerating, rather than its normal state of constant cellular regeneration, known as an “anabolic state.”

In IPS, cells and tissues inside and outside of the brain and spinal cord (CNS) progressively degenerate because of IPS’s combined effects of inflammation, hormonal deficiencies, and autoimmune attacks on tissues. If one has a genetic connective tissue/collagen disorder (EDS or other), then cellular catabolism or deterioration is grossly multiplied.

Cellular deterioration in IPS initially attacks small nerve fibers and the small cells in the CNS and skin, but later other tissues may be involved. Muscle mass deteriorates and is replaced by fatty tissue, so weight gain occurs. In late stages of catabolism, severe muscle loss may occur, giving the patient the appearance of starvation and emaciation. Weakness and fatigue set in. Memory, reading ability and logical thinking decline. Medications, including opioids, may not be as effective as they once were.

Persons with IPS must daily attempt to control catabolism through proper nutrition, which helps stop disease deterioration, reduces inflammation, regrows damaged nerves (neurogenesis), alkalizes body fluids, and improves pain relief and energy.

There are five basic components of an IPS nutrition program:

1. Eat protein every day and include protein in ALL meals.

2. Eat green vegetables, and select fruits and nuts

3. Control cholesterol and glucose

4. Daily multi-vitamins and minerals

5. Daily supplements for nerve regrowth and inflammation

Protein is Key

The most critical component of an IPS nutrition program is protein. IPS tends to decrease a desire for protein and promotes a craving for sugar and starches. The major protein foods are beef, pork, lamb, chicken, turkey, seafood, cottage cheese and eggs. Protein drinks and bars can also be used as alternatives.

Why is protein so important? It contains all the fuel (amino acids) needed by the body to make more endorphin, serotonin, dopamine, norepinephrine, insulin and other hormones. Protein builds tissue, repairs cells and helps stabilize blood sugar. Meals with no protein will likely increase pain and inflammation, which prevents healing.

Foods that are mainly sugar and starches (carbohydrates) cause sugar (glucose) to rise in the blood. Fatty foods cause cholesterol to raise in the blood. New research shows that high levels of glucose and fat may cause inflammation and damage to the neurotransmitters and receptor systems that control pain. 

IPS patients should have their glucose and cholesterol levels tested on a regular basis. If abnormally high or low, work with your medical practitioner to normalize them.  

You can help by reducing sugars and fats in your diet, and by eating meals on a regular schedule, even if you are not hungry. This will help balance your glucose and lessen your pain over time.   

You may also want to consider a gluten free trial. Stop eating bread, cereal, noodles and other foods containing gluten for one week to see if you feel better. 

Green Is Good 

Vegetables, fruits and nuts can also help reduce inflammation, alkalinize your body fluids, and promote tissue healing. The best green vegetables are broccoli, kale, brussel sprouts, asparagus, green beans, spinach, snap peas, chard, mustard greens, turnip greens, collards, and cabbage. Avoid eating potatoes and corn, which are loaded with carbohydrates. 

The best fruits are blueberries, pineapple, raspberries, blackberries, cherries, oranges, plums, apples, strawberries, and peaches. Avoid eating bananas. The best nuts to eat are pistachios, almonds and peanuts. 

To help regrow damaged or diseased tissues, take daily supplements containing vitamins B12 and C, collagen, amino acids and natural hormonal agents such as colostrum or DHEA. A daily multi-vitamin and mineral tablet is also helpful, along with a daily plant-based anti-inflammatory agent such as curcumin/turmeric or quercetin. 

Ask yourself: Is what I am eating right now helping or hurting? If you don’t know or want more information, the IPS Research and Education Project has just published a 12-page nutritional program designed specifically for people with IPS. You can download a free copy by clicking here.  

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

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

Addiction Is the Problem, Not Pain

By Carol Levy, PNN Columnist

The war on drugs always seems to target pain sufferers. We are the number one example of what happens when someone is given opioids. We are the villains, our pain the “gateway” to addiction -- a fiction that no one seems able to dispel, regardless of the evidence and common sense.

Why are we the bad guys? Is it because we are the easiest to single out?

Maybe.

I was watching an episode of the old TV show “ER.” One of the main characters, Dr. John Carter (Noah Wyle), was stabbed repeatedly by a psychotic patient. His pain was horrendous, his need for opioids obvious. Dr. Carter survived the attack, but became addicted. In one scene, he even goes to the extreme of injecting himself with fentanyl.

I began to recall other shows where the plot was the same: injury, opioids to manage the acute pain, and then full-blown addiction.

In an episode of “The Golden Girls,” Betty White's character, Rose Nyland, discloses she was addicted to pain pills. She started taking them 30 years earlier after she injured her back. Her doctor never told her to stop taking them, so she continued using opioids for decades. It was her secret until her roommates figured it out.

It is a shame that TV shows like these don’t include a disclaimer: These characters had acute pain, not chronic. Most people with chronic pain do not become addicted.

It’s a common belief that if you have acute or chronic pain and are given opioids that you will probably become addicted. But has anyone ever studied the two types of pain and their rates of addiction?

I Googled it using the words "chronic pain and addiction vs acute pain and addiction." There were no studies that directly compared the two. The results were either about chronic pain and addiction, or acute pain and addiction. I changed the search terms to “acute pain, opioids, addiction rates.” The results were the same.

Why hasn't anyone looked into the differences in addiction in these two very dissimilar populations?

Why has no one done studies with a population of acute pain patients who became addicted after an injury or surgery? Then compare those rates with chronic pain patients who become addicted?  If they have, I wasn’t able to find them.

Are chronic pain patients being villainized because we are the most visible population?

It is always easier to go after the most desperate and the most vulnerable -- and when it comes to opioids and managing pain, we fit the bill. We will continue to be the bogeyman in the “opioid crisis” until this changes.

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

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.