In Memory of Two Pain Warriors

By Pat Anson, PNN Editor

The pain community is mourning the loss of two of its most dedicated advocates this Memorial Day weekend: Terri Lewis and Jeffrey Fudin.

Dr. Fudin was a clinical pharmacist who specialized in pain management at the Stratton VA Medical Center in Albany, New York. He was also a prolific researcher, blogger and mentor to other clinicians. Fudin died Friday at the age of 63 after a lengthy battle with Stage 4 colon cancer.

Fudin spent much of the past year visiting with family and friends, displaying an extraordinary amount of courage, grace and humor as his prognosis worsened. He even managed to work a few laughs into his own obituary, which he penned himself.

“Seriously, you thought I was going to leave you all without a final post from the grave? If you’re reading this, I am now resting comfortably and hopefully watching over those I most cherished while on earth,” Fudin wrote.

“Someplace there is a lemon tree that will bear fruit from the earth. That sour fruit will provide joy and perhaps lemonade to those I leave behind.”

JEFFREY FUDIN

Terri Lewis’ battle with cancer was shorter and her passing unexpected. She died Saturday at the age of 70 from complications caused by chemotherapy for metastatic melanoma. 

Dr. Lewis was a rehabilitation specialist and educator who specialized in disabilities and mental health. She traveled regularly to Taiwan, where she was an Assistant Professor at National Changhua University of Education.

Lewis was a prolific researcher on issues affecting the pain community, which she shared freely with other advocates and reporters. She and Fudin helped me understand many complex issues when I first started covering pain management a decade ago.

“Terri was one of the most staggeringly intelligent people I have ever met. I remain in awe of her ability to identify and wrangle large data sets and to discern meaningful trends and relationships in healthcare processes with levels of complexity which overwhelm me,” said patient advocate Rose Bigham.

“She was generous with her time, coached and collaborated with many other pain patients and advocates, and was a fierce defender of her adult son who had been neglected and abused by multiple healthcare systems and providers due to his complex health conditions. She was relentless. She taught so many of us to never give up, and to be unafraid of tackling the big problems.”

TERRI LEWIS

“Terri Lewis was a force; her enthusiasm was inspiring, and I think that enthusiasm helped struggling patients keep hope alive and continue to fight, myself included. I am so grateful for all she taught me,” said Anne Fuqua. “There was one day where I was worried sick about a friend with muscular dystrophy who was on a ventilator. His physician had decided to take advantage of having him admitted for IV antibiotics and use this as an opportunity to taper his opioids and he planned to do this over the period of one week. Terri knew exactly who to ask for – and in less than 2 hours the taper was aborted.

“The very best those of us who loved Terri can do is to use what she taught us to help fellow patients as well as ourselves. I hope we can do a tenth the good she did in her lifetime.”

‘They Were Heroes’

It’s an overused expression, but Lewis and Fudin really were “pain warriors” who worked hard to dispel the many myths that surround the use of opioid medication. They risked their careers and reputations while opioid hysteria gripped the nation, patients were abandoned, and doctors were prosecuted for treating pain. When others looked away, Lewis and Fudin stood up to defend them.   

“They were heroes,” says Dr. Mark Ibsen, who fought to regain his medical license after he was suspended by the Montana medical board for “overprescribing” opioids.  

“Terri was a tireless and relentless advocate and teacher. She understood the malfeasance of targeting doctors by the abuse of dating mining,” Ibsen told PNN. “They use these data banks to predict diversion and prescribing ‘outside the usual course of medical practice’ even though nothing of the sort is proven.” 

Much of Fudin’s advocacy was focused on ending the “pseudoscience” of using morphine milligram equivalents (MME) to measure the risks and effectiveness of an opioid – which illogically presumes that every patient and every opioid are identical.

“Jeffrey Fudin debunked the false equivalency of MME levels, noting the bogus assertion that ‘one size fits all’ does not apply to the complexities of human biochemistry and pharmacology,” said Ibsen.  

Fudin’s funeral will be held on June 1 in Albany. In lieu of flowers, it was Fudin’s wish that any memorial tributes be made in the form of a tax deductible donation to the Dr. Jeffrey Fudin Memorial Foundation. 

A Terri Lewis Memorial has also been established at the Arachnoiditis & Chronic Meningitis Collaborative Research Network (ACMCRN), a non-profit that Lewis helped found and where she was VP of Research..

RIP Terri and Jeff.

Experimental Ketamine Pill Effective in Treating Acute Pain

By Pat Anson, PNN Editor

An experimental oral tablet that combines ketamine with aspirin was nearly as effective as an opioid in treating acute pain in emergency room patients, according to the results of a small pilot study.

Ketamine is a non-opioid analgesic that is also used to treat anxiety and depression. The drug is so potent, that it is usually administered by an infusion, injection or nasal spray under strict medical supervision. Some doctors and patients have also found ketamine effective as a treatment for certain chronic pain conditions.

“Ketamine has long been viewed as a highly promising analgesic, but its adverse effect profile, available routes of administration, and short-lasting effects limited its use. Our goal is to overcome all three of these limitations,” says Joseph Habboushe, MD, an emergency room physician and founder of Vitalis Analgesics.

Vitalis has developed a proprietary formulation of aspirin that delivers faster and stronger pain relief than traditional aspirin. The company is working to see if a combination of its aspirin with low-dose ketamine could be used to treat pain.

In the pilot study at Maimonides Medical Center in New York, 25 emergency room patients with acute musculoskeletal pain were given the ketamine-aspirin pill – called VTS-85. After an hour, their pain level scores were reduced an average of 3.8 points, pain relief similar to that of oxycodone-acetaminophen (Percocet) formulations, which reduced pain levels by 4.0 points in previous studies.

Researchers say the pain relief from VTS-85 lasted for two hours, with pain scores dropping an average of 4.4 points. Notably, only 4-8% of patients experienced the dissociation and sedation that is usually experienced when ketamine is administered intravenously.

“The results of this pilot study are highly encouraging, with pain reduction similar to studies using IV ketamine formulations but lasting longer and with lower side effects, and it’s oral,” said Habboushe.

The study findings are published in The Journal of Emergency Medicine.

“If proven in larger controlled trials, this could represent a breakthrough in the treatment of acute pain and a range of other indications,” said lead investigator Sergey Motov, MD, Department of Emergency Medicine, Maimonides Medical Center.

Vitalis has completed a second larger trial on the use of VTS-85 in emergency room patients, but the results have not yet been released. The company is also studying VTS-85 as a treatment for acute headache and postoperative pain. The ketamine-aspirin pill will require a prescription if approved by the FDA.

100,000 ‘Unnecessary’ Hospital Procedures Performed in First Year of Pandemic

By Pat Anson, PNN Editor

U.S. hospitals performed over 100,000 “low-value” procedures on Medicare patients in the first year of the Covid pandemic, including tens of thousands of spinal surgeries and knee arthroscopies, according to a recent study by the Lown Institute, a non-profit that seeks to reduce the use of unnecessary and ineffective medical treatments.

In 2020, no vaccines were available, the elderly were particularly vulnerable to the Covid-19 virus, and intensive care units were filled with infected patients. Yet many hospitals continued to perform questionable elective procedures at the same rate they did in 2019.

“You couldn’t go into your local coffee shop, but hospitals brought people in for all kinds of unnecessary procedures,” Vikas Saini, MD, president of the Lown Institute, said in a statement. “The fact that a pandemic barely slowed things down shows just how deeply entrenched overuse is in American healthcare.”

Lown researchers analyzed Medicare claims from U.S. hospitals for eight procedures that the non-profit considers to have “little to no clinical benefit” and are potentially harmful.  

Coronary stents were the most overused procedure, with over 45,000 balloon angioplasties performed to open up blocked arteries. The Lown Institute has long maintained that stents are unnecessary and risky in patients with stable heart disease.

Two spinal surgeries also made the list: 13,541 spinal fusions and 16,553 vertebroplasties were performed on older patients. In vertebroplasty, bone cement is injected into fractured vertebrae to stabilize the spine; while spinal fusions are used to join two or more vertebrae together to prevent them from moving and causing more pain. The Lown Institute considers fusions and vertebroplasties inappropriate for patients with low back pain and osteoporosis.

Nearly 1,600 knee arthroscopies were also performed in 2020, a type of “keyhole” surgery in which a small incision is made in the knee to diagnose and repair ligaments damaged by overuse or osteoarthritis. Recent independent studies have found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

“There are certain things, certain practices that are just insane. You shouldn’t be doing this. Nobody should pay for this,” said Saini.

Highland Hospital in Rochester, New York was rated as the top hospital in the country for avoiding overuse procedures. Richardson Medical Center in Rayville, Louisiana was ranked as the worst hospital.

The American Hospital Association disputed Lown's ranking system, calling it misleading.

"Throughout the pandemic, but especially in the early months, many nonessential services and procedures were put off due to government restrictions or voluntary actions from hospitals to make room for massive surges of COVID-19 patients," Aaron Wesolowski, AHA's VP of policy research, said in a statement to Becker’s Hospital Review.

"Studies have shown that these delays or sometimes even cancelations in nonemergent care have had some negative outcomes on the health and well-being of patients, who continue to show up at the hospital sicker and with more advanced illnesses. Many of these services may alleviate patients' pain or provide other help to patients. Lown may define these services as 'low value,' but they can be of tremendous value to the patients who receive them."

To Each Life Their Own

By Mia Maysack, PNN Columnist

May is Mental Health Awareness Month, a good time to write about a topic that needs more attention, but one that makes many of us uncomfortable: suicide.

I know people who have tried to end their lives. There was one who almost succeeded. I was still in decent enough health at the time to be working in the nursing field and it just so happened to be my hospital they were brought to. I entered the room in time to watch their stomach being pumped with charcoal, which is the process used to rid the body of whatever has been ingested.  

After being revived, this person's first words to me were: "Why didn't you let me die?" 

My already broken heart shattered once again into a million pieces. Being much younger at the time, I couldn't begin to understand and took the experience personally. Now I’m old enough to know that someone’s choices about their own life have absolutely nothing to do with me. 

Fast forward a few years, and I found myself in a clinical support group at a time when my pain ran rampant and dictated every aspect of my existence. That’s what led me to the textbook-based, power-point class that was instructed by low-energy penny counters. I was that desperate for help. 

During one session, we broke out into smaller groups. On one side of me, there was someone who'd lived in unmanageable pain for 40 years. They were fed up with prior authorizations, insurance hoops and failed treatment options, and confided to the group that they were making plans to move where medically assisted suicide was legal. 

On my other side was someone who claimed they had never felt suicidal and couldn't begin to relate to the other person. In fact, it made them so uncomfortable that they excused themselves from the conversation and went to go tell on the other individual. 

It's human nature to avoid discomfort, but we don't always know how to create space for others who are suffering without also judging them. 

Between these two extremes, there was me -- literally and figuratively in the middle. After class, I watched as the instructors approached the individual in a hushed whisper and exchanged a slip of paper with a suicide hotline number on it.

I witnessed this person break down -- almost as if they were being scolded -- and couldn't help but think that if it was me standing on the edge and was essentially being told to go away and deal with it elsewhere, that might be the very last thing a person would do. And how that would be such a failure on our part. 

It was then that I began my own support group network, which eventually evolved into more of a self-help resource because I personally feel that while support is important, it can only take us so far. 

Despite living in agony, I spent many years clinging to my medical career. At one point I was working in hospice, where I was confronted daily by the truest definition of suffering -- seeing patients barely hanging on for the sake of their families, despite their desire to let go. 

It was then I contemplated who is being more selfish. Is it the person who no longer wants to remain alive because they are already dead inside or those demanding that they go on living? 

There's no right answer to that question. That isn't to belittle how anyone feels on either end of that spectrum, but more a rhetorical point to ponder.  

For many reasons, these last couple of years have been the most difficult of my life and I came the closest I've ever been to ending my own life. Lack of hope is one of the most dangerous places to be. The darkness is all consuming.  

I'm someone who is known for their positivity. It is noticed when I am not acting like myself or feeling a lower level of energy.  People depend upon me to be level headed and focused on the more uplifting aspects of life, but that can be a heavy weight to bear at times. 

It's a blessing to be in the position that I'm in and provide the type of counsel that I do. In fact, I now understand on a deeper level why my medical career meant so much to me. Showing up for others during their most trying times and hardest moments helped distract myself from my own inner turmoil. 

The same can be said about advocacy. Showing up for others whether or not I feel up to it, guiding them to their own voice and sharing their truth  is a way to make something out of my pain. Perhaps I've endured all that I have to gift others with what I've managed to learn. If being human was just about me and what I go through, there’s no way I’d be able to make it.

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

‘My Pain Was No Big Deal’: Obese Patients Often Stigmatized by Doctors

By Lauren Sausser, Kaiser Health News

When Melissa Boughton complained to her OB-GYN about dull pelvic pain, the doctor responded by asking about her diet and exercise habits.

The question seemed irrelevant, considering the type of pain she was having, Boughton thought at the time. But it wasn’t unusual coming from this doctor. “Every time I was in there, she’d talk about diet and exercise,” said Boughton, who is 34 and lives in Durham, North Carolina.

On this occasion, three years ago, the OB-GYN told Boughton that losing weight would likely resolve the pelvic pain. The physician brought up diet and exercise at least twice more during the appointment. The doctor said she’d order an ultrasound to put Boughton’s mind at ease.

The ultrasound revealed the source of her pain: a 7-centimeter tumor filled with fluid on Boughton’s left ovary.

“I hate that doctor for the way she treated me — like my pain was no big deal,” Boughton said. “She seemed to make a decision about me based off of a very cursory look.”

Research has long shown that doctors are less likely to respect patients who are overweight or obese, even as nearly three-quarters of adults in the U.S. now fall into one of those categories. Obesity, which characterizes patients whose body mass index is 30 or higher, is pervasive in the South and Midwest, according to the Centers for Disease Control and Prevention. The state with the highest rate is Mississippi, where 4 in 10 adults qualify as obese.

Obesity is a common, treatable condition linked to a long list of health risks, including Type 2 diabetes, heart disease, and some cancers. Despite obesity’s prevalence, it carries a unique stigma.

‘Almost Like Malpractice’

Doctors often approach the practice of medicine with an anti-fat bias and struggle to communicate with patients whose weight exceeds what’s considered the normal range. Some obesity experts blame a lack of focus on the subject in medical schools. Others blame a lack of empathy.

To counter that, the Association of American Medical Colleges plans to roll out in June new diversity, equity, and inclusion standards aimed at teaching doctors, among other things, about respectful treatment of people diagnosed as overweight or obese.

That’s not happening for many patients, said Dr. Scott Butsch, director of obesity medicine at the Cleveland Clinic’s Bariatric and Metabolic Institute. “This is almost like malpractice. You have these physicians or clinicians — whoever they are — relating everything to the patient’s obesity without investigation,” Butsch said. “The stereotypes and misperceptions around this disease just bleed into clinical practice.”

The problem, Butsch argued, is that too little attention is paid to obesity in medical school. When he trained and taught at Harvard Medical School for several years, Butsch said, students received no more than nine hours of obesity education spread over three days in four years.

In 2013, the American Medical Association voted to recognize obesity as a disease. But, Butsch said, doctors often approach it with a one-size-fits-all approach. “Eat less, move more” doesn’t work for everyone, he said.

Parents and medical providers need to take special care when talking to children who have been diagnosed with obesity about their weight, psychologists have warned. The way parents and providers talk to kids about their weight can have lifelong consequences and in some cases trigger unhealthy eating habits. For children who are obese, obesity experts agree, weight loss isn’t always the goal.

“There are many different forms of obesity, but we’re treating them like we’re giving the same chemotherapy to all kinds of cancer,” Butsch said.

Doctors Poorly Trained About Weight

All but four of the country’s 128 M.D.-granting medical schools reported covering content related to obesity and bariatric medicine in the 2020-21 academic year, according to curriculum data provided to KHN by the Association of American Medical Colleges, which does not represent osteopathic schools.

Even so, research suggests that many physicians haven’t been sufficiently trained to address weight issues with patients and that obesity education in medical schools across the world is “grossly neglected.” A survey completed by leaders at 40 U.S. medical schools found that only 10% felt their students were “very prepared” to manage patients with obesity.

Meanwhile, “half of the medical schools surveyed reported that expanding obesity education was a low priority or not a priority,” wrote the authors of a 2020 journal article that describes the survey’s results.

Butsch wants Congress to pass a resolution insisting that medical schools incorporate substantive training on nutrition, diet, and obesity. He acknowledged, though, that the medical school curriculum is already packed with subject matter deemed necessary to cover.

Dr. David Cole, president of the Medical University of South Carolina, said plenty of topics should be covered more comprehensively in medical school but aren’t. “There’s this massive tome — it’s about this big,” Cole said, raising his hand about a foot off the top of a conference table in Charleston. “The topic is: Things I never learned in medical school.”

The bigger issue, he said, is that medicine has historically been taught to emphasize memorization and has failed to emphasize culturally competent care. “That was valid 100 years ago, if you were supposed to be the fount of all knowledge,” Cole said. “That’s just not valid anymore.”

The Association of American Medical Colleges is trying to tackle the problem in two ways.

First, it developed a professional readiness exam for aspiring medical school students, called PREview, designed to assess an applicant’s cultural competence, social skills, and listening skills, as well as their ability to think through situations they may encounter in medical school and clinical settings.

“We call them softer skills, but they’re really the harder ones to learn,” said Lisa Howley, an educational psychologist and senior director of strategic initiatives at the association. More than a dozen medical schools now recommend or require that applicants submit their PREview test scores with their Medical College Admission Test scores.

Second, the medical college association will roll out new competency standards for existing medical students, residents, and doctors related to diversity, equity, and inclusion in June. Those standards will address racism, implicit bias, and gender equality and will aim to teach doctors how to talk with people who are overweight.

“The bias toward those individuals is way too high,” Howley said. “We have a lot more work to do in this space.”

After the source of Melissa Boughton’s pelvic pain was discovered, the OB-GYN who had recommended diet and exercise to ease her symptoms told Boughton the tumor was no big deal. “She acted like it was the most normal thing in the world,” Boughton said.

Boughton sought a second opinion from a doctor who marketed her practice as a “Healthy at Every Size” office. That doctor referred Boughton to a surgical oncologist, who removed the tumor, her left ovary, and part of a fallopian tube. The tumor was large, but it wasn’t cancerous. And although the surgery to remove it was considered successful, Boughton has since had trouble conceiving and is undergoing fertility treatment as she tries to have a baby.

“It’s an emotional roller coaster,” she said. “I feel very young at 34 to be going through this.”

Boughton — who describes herself as someone who doesn’t “fit into the BMI box” — said the experience taught her to choose her doctors differently.

“You can ask me if I diet and exercise like once,” she said. Any more than that, and she starts shopping for a different doctor.

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

Medical Cannabis Improves Symptoms in Cancer Patients

By Pat Anson, PNN Editor

Medical cannabis improved pain and other symptoms in patients undergoing cancer treatment, while significantly reducing their use of opioids and other analgesics, according to a new study by Israeli researchers.

Over 300 cancer patients participated in the 6-month study, including many who were seriously ill. Breast, colon, lung and ovarian cancers were the most common diagnoses, with about half the patients receiving chemotherapy (55%) or diagnosed with advanced stage IV cancer (48%).

“Traditionally, cancer-related pain is mainly treated by opioid analgesics, but most oncologists perceive opioid treatment as hazardous, so alternative therapies are required,” said lead author David Meiri, PhD, an assistant professor at the Technion-Israel Institute of Technology in Haifa.

“Our study is the first to assess the possible benefits of medical cannabis for cancer-related pain in oncology patients; gathering information from the start of treatment, and with repeated follow-ups for an extended period of time, to get a thorough analysis of its effectiveness.”

Patients ingested cannabis that was rich in tetrahydrocannabinol (THC) through oil extracts, smoking or a combination of the two. For many, it was their first time using cannabis.

Most patients (60%) reported a positive effect from cannabis treatment, with significant improvement in their anxiety, depression, sleep, quality of life and pain catastrophizing. Most reported a small improvement in pain intensity and 20% said there was no improvement in their pain levels.

There was, however, a significant change in the use of analgesics. About 40 percent of patients who were taking pain medication of some kind (opioids, NSAIDs, anticonvulsants or antidepressants) stopped taking the drugs while using cannabis.

“We encountered numerous cancer patients who asked us whether medical cannabis treatment can benefit their health,” said co-author Gil Bar-Sela, MD, an associate professor at the Ha'Emek Medical Center Afula. “Our initial review of existing research revealed that actually not much was known regarding its effectiveness, particularly for the treatment of cancer-related pain, and of what was known, most findings were inconclusive.”

Notably, about one in every five participants died during the course of the study, which researchers attributed to their poor health and advanced cancer. Many of the patients also lost weight.

“Medical cannabis has been suggested as a possible remedy for appetite loss, however, most patients in this study still lost weight. As a substantial portion were diagnosed with progressive cancer, a weight decline is expected with disease progression,” said Meiri. “Interestingly, we found that sexual function improved for most men but worsened for most women.”

Overall, researchers say cannabis treatment provided “mild to modest” improvement in cancer patients, with only minor side effects. Their findings were published in the journal Frontiers in Pain Research.

The Real Story Behind the Overdose Epidemic

By Stefan Franzen, Guest Columnist

A recent commentary in The New York Times by German Lopez (“The Perils of Legalization’) flatly states that prescription opioids caused the overdose epidemic.

“The problem began with a legal, regulated drug: prescription painkillers,” Mr. Lopez writes, while building a case against legalization as a solution to our drug problems.

“Many of the people now using heroin or fentanyl began with painkillers. And drug cartels started to more aggressively ship heroin and fentanyl to the U.S. once they saw a promising customer base in the growing number of painkiller users.”

Mr. Lopez is confused. Heroin has been illegal in the U.S. since Congress passed the Harrison Act in 1914, yet that hasn’t stopped millions of Americans from trying heroin, just as Prohibition failed to stop people from drinking alcohol. The same is true for other illegal drugs, such cocaine, LSD and marijuana.

Prescription opioids are legal drugs when obtained by a doctor’s prescription. To suggest that we tried legalization and it failed is simply not true. Perhaps Mr. Lopez is confusing the liberalization of opioid prescribing that began in 1997 with legalization. In that case, yes, there was a movement in the medical community and by some drug makers to expand the use of opioids for pain.

Mr. Lopez does report correctly that many of the problems that arose during that period resulted from the failure of the Drug Enforcement Administration to carry out its responsibility to investigate when there was evidence of massive shipments of painkillers to rural counties by companies such as Purdue Pharma.

The role of the government in failing to protect consumers is the real story missed by the mainstream media, who are too busy informing the public about the latest lawsuit against pharmaceutical companies and opioid distributors. The consumers who were hurt the most were, and still are, persistent pain patients.

Of course, it is also tragic that many people were caught up in opioid prescribing and became addicted, due to a complete failure to investigate when Purdue began sending millions of OxyContin pills to rural counties in states like West Virginia and Tennessee. The mistake made here was not “legalization.” It was permitting greed and corruption to co-opt an effort by the medical community to reach people who had the greatest pain.

It is a false narrative that the overdose epidemic arose from the expansion of opioid prescribing and that drug cartels are only targeting pain patients.

Recent data from the Centers for Disease Control and Prevention show why that is a totally false assumption. The CDC estimates that nearly 108,000 people died from overdoses in 2021, a 15% increase from the year before. Drug deaths involving synthetic opioids – mostly illicit fentanyl – rose to 71,000, and there were 33,000 deaths linked to methamphetamine and other stimulants.  

Only 13,000 overdoses last year were linked to prescription opioids -- about 12% of all drug deaths -- but there is no data available to tell us how many of those overdoses involved patients who were actually prescribed the drugs. It’s safe to assume most of those who died took a prescription opioid intended for someone else that was bought or stolen. Or perhaps they took one of the millions of counterfeit pills flooding the country.     

Overdose deaths due to illicit fentanyl and other street drugs have been rising for years, yet nearly every media story continues to exaggerate the role of prescription opioids, leaving the public with the completely mistaken impression that doctors prescribing to pain patients caused the overdose epidemic. Commentators like Mr. Lopez, who have few facts to back up their statements, have no idea how much harm these statements cause to our most vulnerable citizens.

There was no “legalization” of prescription drugs, since they were already legal. And it was not a failed experiment to treat people in pain with greater decency -- just greed, corruption and incompetence that spoiled efforts to bring some quality of life to patients who suffer the worst types of pain, whether it is sickle cell disease, ankylosing spondylitis, psoriatic arthritis, Ehlers-Danlos syndrome, muscular dystrophy or adhesive arachnoiditis.

Others who suffer terrible pain are wounded veterans, car accident survivors and burn victims. I did not mention cancer, which obviously can be extremely painful, only because cancer is the one disease that commentators sometimes admit should be treated with opioid therapy. Lacking a pain meter to provide data, I will simply point out that any disease that causes substantial physiological changes, inflammation or tissue degeneration can be intensely painful. We should all respect that fact. We are all susceptible to pain.   

We must meet the anti-opioid zealots whenever they write or speak and call them out for their inaccurate and ill-informed commentary. Sadly, forums like National Public Radio and The New York Times did not respond to my attempts to call attention to the facts they got wrong. As a scientist, I believe in evidence.

Stefan Franzen, PhD, is a Professor of Chemistry at North Carolina State University.

Franzen is the author of “Patient Z” – a book that looks at pain, addiction and the opioid crisis through the eyes of a patient who can’t find good pain care because opioid medication has been criminalized and many doctors are now too afraid to prescribe it.

FDA Head Wants New Regulations for Kratom and CBD

By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”

Can ‘Medical Food’ Treat Chronic Pain?

By Pat Anson, PNN Editor

Do you keep a supply of gamma-aminobutyric acid in your medicine cabinet? What about hydroxytryptophan? Or the ominous sounding devil’s claw root?

They’re not exactly household names to the average person, but to Fabio Lanzieri they are essential ingredients in a new “medical food” product called Proleeva, a dietary supplement he developed that contains a blend of a dozen natural herbs, enzymes and amino acids.

“I fervently believe that prescription medications are very beneficial to man, but I also believe that nature does offer us the ability to find solutions to natural diseases. Because of this, I was always interested and read a lot about vitamins, supplements and bioflavonoids,” says Lanzieri, who spent nearly four decades in the pharmaceutical industry. “I believe that supplementing prescription medications with natural substances is the best way of treating chronic pain or any disease state.”

Several years ago, Lanzieri’s wife Maria began experiencing joint pain as a side effect of taking a hormone suppressant to help her recover from breast cancer.     

“I did start feeling the pain in my joints, particularly my fingers. I was having a really hard time sometimes just opening a bottle or doing simple things,” Maria told PNN.

To help his wife, Lanzieri began experimenting with different blends of herbs and other natural substances. Some, like ginseng and curcumin, have been used for centuries as natural remedies for pain and inflammation. Others, like choline bitartrate and L-arginine, have only recently been recognized as essential nutrients that help restore amino acids and neurotransmitters to healthy levels.

You can buy all of these supplements individually, but Lanzieri combined them all into one proprietary formula and gave it to Maria. Her joint pain slowly began to improve.

“After about a month, month and a half, I started having relief of those symptoms.  I didn’t have the joint pain. I felt like I could do a lot of those tasks that I couldn’t do before,” Maria said. “At one point I stopped taking it and it then was all coming back. It was weird. I didn’t think it was the Proleeva. I didn’t associate it with that. But then I went back on it and suddenly I was not feeling it again.”

The Lanzieri’s began sharing Proleeva with family and friends, who also reported positive results.

Only recently have they begun selling Proleeva to the general public on their website and through Amazon, marketing it as “the ultimate comfort food” that “helps bring your nervous system back into balance.”

A Proleeva bottle contains 120 capsules – about a month’s supply – and costs $40.

“I’ve been taking Proleeva for the last seven years and I don’t have any inflammation. I take it because it balances the body with the right ingredients that it needs to fight to heal itself,” says Lanzieri. “Your body needs amino acids and they are not reproduced naturally in the body. And over time, the older we get, the less we have of those amino acids. And therefore, we have to supplement them.”

For now, there is only anecdotal evidence to support these health claims, although a small clinical trial of Proleeva is underway.  Unlike pharmaceuticals, dietary supplements are only loosely regulated by the Food and Drug Administration, allowing supplement makers to introduce new products and make health claims without substantial evidence that they work.

‘One Formulation Makes a Lot of Sense’

Dr. Forest Tennant is intrigued by Proleeva. An expert in treating intractable pain, Tennant recommends that pain patients take gamma-aminobutyric acid (GABA), herbs and other supplements as part of their medical treatment to restore damaged nerve tissue and relieve pain.

“Having a lot of different supplements in one formulation actually makes a lot of sense, because we’re not certain which ones are going to work,” says Tennant. “But I do think there is some urgency or necessity in people with pain taking a variety of these supplements. They can’t hurt themselves and they probably are going to benefit themselves.

“And this particular product is doing something else. It recognizes that it’s got stuff in there like GABA that stimulates the nerve receptors that provide pain relief.”  

Tennant says the supplement industry has become more innovative than the pharmaceutical industry – particularly in an age when opioids and some other medications are harder to get.

“I think the innovation is really great,” Tennant said. “I really think that anyone who has chronic pain, particularly constant pain, really needs to be on a number of supplements right now. We’ll figure out exactly which ones work the best later, but right now I think taking a combination of these things is worthwhile.”

People who try Proleeva or other supplements should not expect instant results. It may take up to a month to feel any benefits.

“The biggest problem is making them stay with this for 30 days. We’re a society of instant gratification. Prescription drugs do that. But unfortunately, natural substances take time,” says Lanzieri.

Long Covid Symptoms Often Overlooked in Seniors

By Judith Graham, Kaiser Health News

Nearly 18 months after getting covid-19 and spending weeks in the hospital, Terry Bell struggles with hanging up his shirts and pants after doing the laundry.

Lifting his clothes, raising his arms or arranging items in his closet leave Bell short of breath and often trigger severe fatigue. He walks with a cane, only short distances. He’s 50 pounds lighter than when the virus struck.

Bell, 70, is among millions of older adults who have grappled with long covid — a population that has received little attention even though research suggests seniors are more likely to develop the poorly understood condition than younger or middle-aged adults.

Long covid refers to ongoing or new health problems that occur at least four weeks after a covid infection, according to the Centers for Disease Control and Prevention. Much about the condition is baffling: There is no diagnostic test to confirm it, no standard definition of the ailment, and no way to predict who will be affected.

Common symptoms, which can last months or years, include fatigue, shortness of breath, an elevated heart rate, muscle and joint pain, sleep disruptions, and problems with attention, concentration, language, and memory — a set of difficulties known as brain fog.

Ongoing inflammation or a dysfunctional immune response may be responsible, along with reservoirs of the virus that remain in the body, small blood clots, or residual damage to the heart, lungs, vascular system, brain, kidneys, or other organs.

Only now is the impact on older adults beginning to be documented. In the largest study of its kind, published recently in the journal BMJ, researchers estimated that 32% of older adults in the U.S. who survived covid infections had symptoms of long covid up to four months after infection — more than double the 14% rate an earlier study found in adults ages 18 to 64. Other studies suggest symptoms can last much longer, for a year or more.

The BMJ study examined more than 87,000 adults 65 and older who had covid infections in 2020, drawing on claims data from UnitedHealth Group’s Medicare Advantage plans. It included symptoms that lasted 21 days or more after an infection, a shorter period than the CDC uses in its long covid definition. The data encompasses both older adults who were hospitalized because of covid (27%) and those who were not (73%).

The higher rate of post-covid symptoms in older adults is likely due to a higher incidence of chronic disease and physical vulnerability in this population — traits that have led to a greater burden of serious illness, hospitalization, and death among seniors throughout the pandemic.

“On average, older adults are less resilient. They don’t have the same ability to bounce back from serious illness,” said Dr. Ken Cohen, a co-author of the study and executive director of translational research for Optum Care, a network of physician practices owned by UnitedHealth Group.

“The challenge is that nonspecific symptoms such as fatigue, weakness, pain, confusion, and increased frailty are things we often see in seriously ill older adults.”

— Dr. Charles Semelka

Applying the study’s findings to the latest data from the CDC suggests that up to 2.5 million older adults may have been affected by long covid. For those individuals, the consequences can be devastating: the onset of disability, the inability to work, reduced ability to carry out activities of daily life, and a lower quality of life.

But in many seniors, long covid is difficult to recognize.

“The challenge is that nonspecific symptoms such as fatigue, weakness, pain, confusion, and increased frailty are things we often see in seriously ill older adults. Or people may think, ‘That’s just part of aging,’” said Dr. Charles Thomas Alexander Semelka, a postdoctoral fellow in geriatric medicine at Wake Forest University.

Ann Morse, 72, of Nashville, Tennessee, was diagnosed with covid in November 2020 and recovered at home after a trip to the emergency room and follow-up home visits from nurses every few days. She soon began having trouble with her memory, attention and speech, as well as sleep problems and severe fatigue. Though she’s improved somewhat, several cognitive issues and fatigue persist to this day.

“What was frustrating was I would tell people my symptoms and they’d say, ‘Oh, we’re like that too,’ as if this was about getting older,” she told me. “And I’m like, but this happened to me suddenly, almost overnight.”

Bell, a singer-songwriter in Nashville, had a hard time getting adequate follow-up attention after spending two weeks in intensive care and an additional five weeks in a nursing home receiving rehabilitation therapy.

“I wasn’t getting answers from my regular doctors about my breathing and other issues. They said take some over-the-counter medications for your sinus and things like that,” he said. Bell said his real recovery began after he was recommended to specialists at Vanderbilt University Medical Center.

Long Covid and Dementia

James Jackson, director of long-term outcomes at Vanderbilt’s Critical Illness, Brain Dysfunction, and Survivorship Center, runs several long covid support groups that Morse and Bell attend and has worked with hundreds of similar patients. He estimates that about a third of those who are older have some degree of cognitive impairment.

“We know there are significant differences between younger and older brains. Younger brains are more plastic and effective at reconstituting, and our younger patients seem able to regain their cognitive functioning more quickly,” he said.

In extreme cases, covid infections can lead to dementia. That may be because older adults who are severely ill with covid are at high risk of developing delirium — an acute and sudden change in mental status — which is associated with the subsequent development of dementia, said Dr. Liron Sinvani, a geriatrician and an assistant professor at Northwell Health’s Feinstein Institutes for Medical Research in Manhasset, New York.

Older patients’ brains also may have been injured from oxygen deprivation or inflammation. Or disease processes that underlie dementia may already have been underway, and a covid infection may serve as a tipping point, hastening the emergence of symptoms.

Research conducted by Sinvani and colleagues, published in March, found that 13% of covid patients who were 65 and older and hospitalized at Northwell Health in March 2020 or April 2020 had evidence of dementia a year later.

Dr. Thomas Gut, associate chair of medicine at Staten Island University Hospital, which opened one of the first long covid clinics in the U.S., observed that becoming ill with covid can push older adults with preexisting conditions such as heart failure or lung disease “over the edge” to a more severe impairment.

“It’s hard to attribute what’s directly related to covid and what’s a progression of conditions they already have,” said Gut.

That wasn’t true for Richard Gard, 67, who lives just outside New Haven, Connecticut, a self-described “very healthy and fit” sailor, scuba diver, and music teacher at Yale University who contracted covid in March 2020. He was the first covid patient treated at Yale New Haven Hospital, where he was critically ill for 2½ weeks, including five days in intensive care and three days on a ventilator.

In the two years since, Gard has spent more than two months in the hospital, usually for symptoms that resemble a heart attack. “If I tried to walk up the stairs or 10 feet, I would almost pass out with exhaustion, and the symptoms would start — extreme chest pain radiating up my arm into my neck, trouble breathing, sweating,” he said.

Dr. Erica Spatz, director of the preventive cardiovascular health program at Yale, is one of Gard’s physicians. “The more severe the covid infection and the older you are, the more likely it is you’ll have a cardiovascular complication after,” she said. Complications include weakening of the heart muscle, blood clots, abnormal heart rhythms, vascular system damage, and high blood pressure.

Gard’s life has changed in ways he never imagined. Unable to work, he takes 22 medications and can still walk only 10 minutes on level ground. Post-traumatic stress disorder is a frequent, unwanted companion.

“A lot of times it’s been difficult to go on, but I tell myself I just have to get up and try one more time,” he told me. “Every day that I get a little bit better, I tell myself I’m adding another day or week to my life.”

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

Pregnant Women Raise Risk of Complications by Using OTC Pain Relievers

By Pat Anson, PNN Editor

Pregnant women who take over-the-counter pain relievers are one-and-a-half times more likely to have complications, including stillbirth and premature delivery, according to a large new study.

Researchers at the University of Aberdeen analyzed data from over 151,000 pregnancies in the UK from 1985-2015, looking for medical notes indicating the women used paracetamol (acetaminophen), aspirin or the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen and ibuprofen — either alone or in combinations.

The findings, recently published in BMJ Open, show a significantly higher risk of a preterm delivery, neonatal death, low birth weight and other health problems in babies born to mothers who used OTC pain relievers. Neural tube defects of the brain, spine or spinal cord were 64% more likely; while hypospadias, a birth defect affecting the penis, was 27% more likely.

“Over-the-counter analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk,” wrote lead author Aikaterini Zafeiri, PhD. “The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.”

One of the more surprising aspects of the study is how use of the five analgesics by pregnant women grew dramatically over the 30-year study period.  In 1985, only 1.8% reported using one of the pain relievers. By 2015, that had grown to 70.6% -- with most of the increase coming in the last seven years of the study.

Although it is believed to be one of the largest and most comprehensive studies of its kind, the research was limited. The duration, dose and stage of the pregnancy when analgesics were consumed were not recorded. The health of the mothers and babies later in life was also not studied.

But given the substantial increase in analgesic use during pregnancy and the higher risk of complications, researchers say more caution is needed on use of the drugs.

“The ease of access to non-prescription painkillers, in combination with availability of misinformation as well as correct information through the internet, raises safety concerns,” said Zafeiri. “It should be reinforced that paracetamol in combination with NSAIDs is associated with a higher risk and pregnant women should always consult their doctor or midwife before taking any over-the-counter drugs. We would encourage a strong reinforcement of the official advice for pregnant women.”   

Previous studies have linked prenatal use of paracetamol to autism, hyperactivity and behavioral problem in children. Despite the findings, drug regulators in the UK and US maintain that it is safe for pregnant women to use paracetamol (acetaminophen).

“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 UK’s National Health Service (NHS) says on its website.

The 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.  

Meanwhile, drug regulators in Australia are so concerned about recent deaths involving paracetamol that they may restrict access to the drug. Australia’s Therapeutic Goods Administration (TGA) has commissioned a report by an expert panel on the risks of paracetamol misuse.

“While paracetamol has well established safety and toxicity profiles, the wide use is paralleled by a high prevalence of accidental and deliberate paracetamol poisoning in the community, in both adults and children,” the TGA said in a statement earlier this month.

“The TGA is aware of concerns, particularly of families and healthcare professionals of affected consumers of paracetamol, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets, and whether current access restrictions are appropriate.”

Australia currently regulates the quantity and dose of paracetamol sold over-the-counter. The independent commission will consider if stricter buying limits should be imposed. 

Long Covid Symptoms Persist Two Years After Hospitalization

By Pat Anson, PNN Editor

About half the patients who were first hospitalized in China with the COVID-19 virus still had symptoms of pain, fatigue or insomnia two years after being discharged, according to a new study that suggests that long covid may persist long after the initial infection.

Long covid is a poorly understood disorder characterized by body pain, fatigue, cognitive impairment and difficulty sleeping.

Wuhan, China was the epicenter of the COVID-19 pandemic in early 2020, which makes it a good place to study how infections with the original strain of the virus affect patients long-term.

Researchers at the China–Japan Friendship Hospital in Beijing followed nearly 1,200 patients who were hospitalized in Wuhan with acute COVID-19 between January 7 and May 29, 2020, and reassessed them six months, 12 months and two years after discharge.

While their physical and mental health generally improved over time, regardless of disease severity, researchers found that 55% of the Wuhan patients still had at least one Covid symptom after two years, compared to 68% after six months. Many reported a poorer quality of life, less ability to exercise, more mental health problems, and increased use of healthcare services compared to people who were not infected.

“Our findings indicate that for a certain proportion of hospitalised COVID-19 survivors, while they may have cleared the initial infection, more than two years is needed to recover fully from COVID-19,” said lead author Bin Cao, MD, Vice President and Director, Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital

“Ongoing follow-up of COVID-19 survivors, particularly those with symptoms of long COVID, is essential to understand the longer course of the illness, as is further exploration of the benefits of rehabilitation programmes for recovery. There is a clear need to provide continued support to a significant proportion of people who’ve had COVID-19, and to understand how vaccines, emerging treatments, and variants affect long-term health outcomes.”

Nearly 90% of the Wuhan patients were well enough to return to work after two years, despite lingering health problems. Nearly a third (31%) reported fatigue or muscle weakness and sleep difficulties. They were also more likely to report joint pain, palpitations, dizziness, headaches, difficulty breathing, anxiety and depression.

“To the best of our knowledge, this is the longest longitudinal follow-up study of individuals who have recovered from acute COVID-19,” researchers reported in The Lancet Respiratory Medicine.

“Throughout the 2 years after acute infection, hospital survivors with COVID-19 continued to recover in terms of symptomatic sequelae, exercise capacity, mental health, and quality of life, regardless of initial disease severity, but a fairly high burden of symptoms was still seen at 2 years. The COVID-19 survivors had not returned to the same health status as the general population 2 years after acute infection, so ongoing follow-up is needed to characterise the protracted natural history of long COVID.”

More than two years after COVID-19 first appeared in Wuhan, China is having another COVID crisis – this one caused by the Omricon variant of the virus. About 400 million people are currently living under some form of lockdown, with residents of China’s largest city, Shanghai, confined to their homes for weeks.

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Anti-Inflammatory Drugs May Contribute to Chronic Pain

By Pat Anson, PNN Editor

Anti-inflammatory drugs that are widely used to treat short-term acute pain disrupt the body’s natural healing process and increase the chances of developing chronic pain, according to a provocative new study by an international team of researchers.

If true, it means that ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory drugs (NSAIDs) used by millions of people every day for the temporary relief of acute pain may contribute to long-term pain that is even harder to treat.    

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs. But we found that this short-term fix could lead to longer-term problems,” said co-author Jeffrey Mogil, PhD, Professor of Pain Studies and the Canada Research Chair in the Genetics of Pain at McGill University in Montreal.

In a series of studies, Mogil and his colleagues first analyzed genes and immune cells in the blood of 98 patients with acute lower back pain (LBP), noting which patients became free of pain and which ones developed chronic pain after three months.  

In patients who became pain free, there was an early inflammatory response to acute pain that activated neutrophils -- a type of white blood cell that helps the body fight infection.

In patients with chronic pain, there was no inflammatory immune response. This suggests that neutrophils play an active role in resolving pain and protecting patients from transitioning to chronic pain.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” said Mogil.

The study findings, published in Science Translational Medicine, were replicated in a cohort of patients with temporomandibular disorder (TMD), a painful inflammation of the jaw.

Researchers also tested their theory on laboratory animals, giving mice with acute pain the anti-inflammatory steroid dexamethasone or the NSAID diclofenac. While the drugs were initially effective, researchers found that blocking neutrophils in mice ultimately prolonged their pain up to ten times the normal duration. Three other analgesics without anti-inflammatory properties (gabapentin, morphine and lidocaine) produced short-term pain relief without affecting the overall duration of pain in mice.

These findings were also supported by a separate analysis of health records for 500,000 people in the United Kingdom with acute LBP. Those that took NSAIDs were nearly twice as likely to still have pain 2 to 6 years later than those who did not take NSAIDs. Patients who took acetaminophen (paracetamol) or antidepressants – neither of which are anti-inflammatory --  were not at higher risk of transitioning to chronic LBP.

“Our findings suggest it may be time to reconsider the way we treat acute pain. Luckily pain can be killed in other ways that don’t involve interfering with inflammation,” said co-author Massimo Allegri, MD, Head of Pain Service at Policlinico of Monza Hospital in Italy and Ensemble Hospitalier de la Cote in Switzerland.

Researchers say their findings should be followed up with larger clinical trials directly comparing the long-term effects of anti-inflammatory drugs to other pain relievers that don’t disrupt inflammation.

“Together, our results suggest that active immune processes confer adaptation at the acute pain stage, and impairment of such inflammatory responses in subjects with acute LBP (or TMD) increases the risk of developing chronic pain. These adaptive inflammatory responses are intrinsically transcriptionally driven, probably modified by both genetics and environmental factors, and can be inhibited by steroids and NSAIDs,” researchers said.

“Our conclusions may have a substantial impact on medical treatment of the most common presenting complaints to health care professionals. Specifically, our data suggest that the long-term effects of anti-inflammatory drugs should be further investigated in the treatment of acute LBP and likely other pain conditions.”

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products, including over-the-counter cold and flu medications, that many consumers may not be aware how often they use NSAIDs. At high doses, studies have found that NSAIDs increase the risk of a heart attack or stroke.

The current draft revision of the CDC opioid guideline recommends that NSAIDs should be used for low back pain, painful musculoskeletal injuries, dental pain, postoperative pain, kidney stones and acute pain caused by episodic migraine.

Acetaminophen also has its risks. Long-term use has been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Emergency Treatment of Arachnoiditis After Spinal Injection

By Dr. Forest Tennant, PNN Columnist

In rare cases, symptoms suggesting adhesive arachnoiditis (AA) may occur after a spinal tap or epidural injection (therapeutic or obstetrical). These early symptoms may include localized lumbar pain, headaches, burning sensations, dizziness, leg weakness and bladder dysfunction. Spinal fluid leaks or blood in the spinal canal are often suspected in these cases.  

If symptoms indicate the possibility that AA may be developing, we recommend emergency treatment to hopefully prevent the spinal nerve inflammation from spreading and becoming chronic. 

A problem that we have routinely discovered is that medical practitioners commonly have the false belief that they can see signs of AA on an MRI when symptoms begin or within a few hours or days after a spinal tap or epidural injection. But AA typically does not show on an MRI for at least four to six weeks. Consequently, early emergency treatment must be based on patient history and symptoms, rather than on MRI findings. 

At the First International Congress on Arachnoiditis and Tarlov Cysts in 2010, physicians Donna Holder and Antonio Aldrete recommended that methylprednisolone 500 mg be given intravenously every day for five days as an emergency treatment for AA.  

Since that time, a variety of intravenous methylprednisolone attempts with different dosages and frequency have been used by physicians as emergency treatment to prevent AA. Dr. Aldrete opined that intravenous methylprednisolone is only effective in preventing AA if given within 60 days after the spinal tap or epidural. 

We have used the following alternative treatments to intravenous methylprednisolone: 

1. Medrol (methylprednisolone) six-day oral dose pack

2. Ketorolac 30 to 60 mg injection for three consecutive days

3. Medroxyprogesterone 10 mg given twice a day for six days

In some, but not all cases, AA symptoms will abate during the week that either intravenous methylprednisolone or the alternative treatments are administered. In most cases, however, symptoms reduce but don’t totally abate. The reason for this is unclear, but a reasonable assumption is that spinal canal inflammation may not be totally reversed once symptoms begin. 

If pain and other symptoms don’t totally abate, we recommend that the patient begin a three-component medical protocol for AA described in this bulletin, which includes nutritional, physiologic and pharmacologic elements. Patients should remain on these medical treatments until and if their pain and other symptoms resolve. 

It is unclear why only a small percentage of persons who have spinal taps or epidural injections develop AA. It is also unknown why symptoms that begin after these procedures usually don’t abate. 

A New Handbook for Practitioners

Our new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is now available on Amazon. 

This handbook for medical practitioners has been written for one simple reason.  AA is no longer a rare disease.  We conservatively estimate that there are at least 1.75 to 2.75 million adults in the U.S. who have AA.  

In the past, the cause of their back pain was often listed as unknown or inappropriately labeled as failed back syndrome, degenerative spine or simply low back pain. 

It is our fervent hope that this book will help medical practitioners and their patients diagnose and treat this most debilitating disease.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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