Evidence Lacking for Spinal Cord Stimulators

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By Drs. Ian Harris, Adrian Traeger and Caitlin Jones

In an episode of the Australian Broadcasting Corporation’s “Four Corners” this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

What Does the Evidence Say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”

.We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000 (US$ 32,542). With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry Influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners’ “Pain Factory” report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, MD, is a Professor of Orthopedic Surgery at University of New South Wales.  He is a practicing orthopedic trauma surgeon and directs a research unit specializing in surgical outcomes and the evidence base for surgery.

Adrian Traeger, PhD, is a Research Fellow at the Institute for Musculoskeletal Health at The University of Sydney. He is a physiotherapist who specializes in treating low back pain and other musculoskeletal conditions.

Caitlin Jones, PhD, is a postdoctoral research associate at the University of Sydney. Her research evaluates the benefits and harms of treatments for musculoskeletal conditions.

This article originally appeared in The Conversation and is republished with permission.

How Insurers Take Advantage of Copay Assistance Programs

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By Barby Ingle, PNN Columnist 

With the prices of many medications soaring, copay assistance programs are gaining in popularity. Drug manufacturers create copay programs to help insured patients afford expensive medications by covering all or part of their deductible, copays and other out-of-pocket expenses. That can save patients hundreds or even thousands of dollars on a single prescription.

But when insurers, pharmacy benefit managers (PBMs) and employers no longer count the copay assistance toward a deductible, it can lead to unexpectedly high bills for patients, including many who are chronically or terminally ill. The patient is often shocked when they receive a bill for a medication that is significantly higher than usual.  

“When insurers and PBMs do not count the value of copay assistance toward cost-sharing requirements, patients often experience a ‘copay surprise’ at the pharmacy counter and may be forced to walk away without their needed medication because they cannot afford it,” says California Assemblymember Akilah Weber, MD, (D-La Mesa).

Weber recently introduced AB 2180 to ban these copay “accumulator” programs by requiring PBMs and insurers to apply copay assistance towards a patient’s deductible and other out-of-pocket expenses. The goal is to ensure that copay assistance helps the people it is intended for – patients -- rather than lower an insurer’s costs. 

Accumulator programs, also known as "accumulator adjustments" or "copay maximizers,” have already been banned in 19 states, including Arkansas, Arizona, Colorado, Connecticut, Delaware, Georgia, Illinois, Kentucky, and Louisiana.

Over 80 national and California advocacy organizations that make up the All Copays Count in California Coalition have endorsed AB 2180, saying it would protect the most vulnerable patients from “harmful and deceptive insurance schemes.” According to one study, up to 70% of patients abandon their prescriptions when their out-of-pocket costs reach $250 or more.

“Chronic and terminal illnesses create tremendous financial challenges for patients and their families. When insurers utilize copay accumulator policies which do not count third-party payment towards the deductible or out-of-pocket maximum, patients often cannot afford their medications, which has serious health implications,” Siri Vaeth, Executive Director of the Cystic Fibrosis Research Institute, said in a statement.

But PBM’s and insurers say the criticism is unfair. They say copay assistance programs are often little more than marketing ploys by the drug industry to discourage patients from switching to lower cost medications. Insurers say capturing that copay money – by not applying it towards deductibles -- helps them slow the rising cost of premiums. Some are working with third-party companies like PrudentRX and SaveOnSP to identify and implement more of these costs savings.  

There has been bipartisan legislation introduced in Congress at the federal level, which will require financial assistance to count toward deductibles and other out-of-pocket costs. The Help Ensure Lower Patient Copays Act would apply to plans not already subject to state rules. The bill was introduced last year, but has yet to get past the committee stage. 

As the healthcare industry continues to evolve, it is likely that insurers will create more of these “maximizer” programs. If you are paying for more out of pocket expenses due to insurance policies, I encourage you to share your story here and on social media.  

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Living on False Hope

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By Carol Levy, PNN Columnist

I live on false hope. I think hope is what keeps many of us afloat. And when the medical community tells you, “I have nothing left to offer you,” false hope is all there is.

And then I open my email, and there is a story in KevinMD, a medical site that I trust. It’s about using ultrasound as a treatment for pain. My heart soars with anticipation. Maybe, maybe this time, the answer has arrived.

The headline, “Ultrasound shows promise as new pain treatment, targeting a specific brain region,” sets off a specific area of my brain. I feel the false hope lifting and true hope taking its place.

And then I read the article.

Just like too many other studies I have read, this is not research that can be applicable to many people. The researchers only used a sample population of 23 people. That is just too small a number to extrapolate out to the larger pain community.

I have had many brain surgeries for my trigeminal neuralgia, so I'm not put off by a treatment that targets the brain. But the author of the article wonders if stimulating areas of the brain with ultrasound could be used for nefarious purposes, such as torture. 

I was going to do research to see what other new ideas and treatments are out there. Then I realized I didn’t really want to know, because most of the research doesn’t pan out or involves too few people to take it seriously.

I want to read about research involving enough participants that there is real hope in what they found. A study that uses a large number of people and with results so positive that it may be a realistic treatment option.

So far, I haven’t seen that. I know the pharmaceutical industry is working on non-opioid pain relievers, but I think the better way to go would be to find something that minimizes our pain. I'm afraid there may be no way to ever truly eradicate many painful conditions. 

Until I find a study involving hundreds or thousands of participants using a new pain treatment that actually works, is affordable, and has few side effects, I suppose false hope is better than none. 

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. 

The Horrors of TMJ: Futile Treatments for Chronic Jaw Pain

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By Brett Kelman, KFF Health News, and Anna Werner, CBS News  

A TMJ patient in Maine had six surgeries to replace part or all of the joints of her jaw.

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy … put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health.

Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by KFF Health News and CBS News.

JENNY FELDMAN

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” — not compelling scientific evidence nor consistent results — according to the National Academies of Sciences, Engineering and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “not a lot of evidence” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with KFF Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a comprehensive study of TMJ disorders by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “minimal or no training” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

The American Dental Association, which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

‘Not Taken Seriously’

Scientific studies have found that TMJ disorders arise up to nine times as often in women, particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in a 2021 newsletter from the organization. “And surgeons need to stop blaming this condition on women.”

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say ‘Run!’”

LISA SCHMIDT AND A 2017 MEDICAL SCAN OF HER FACE

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the 426-page report published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. … Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “notable absence of sufficient evidence” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite — like installing braces or crowns or grinding teeth down — has “no supporting evidence,” according to the national academies report. The NIH warns that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and pain medicines can be too weak or addictive to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have raised concerns about bone loss during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a TMJ research collaborative and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to the standards that dental schools must teach to be accredited in 2022. The national academies launched an ongoing forum on TMJ disorders last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, ‘We want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacement

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its most closely monitored medical devices because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

JENNY FELDMAN HAD 2 TOTAL JAW REPLACEMENTS

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “patient-facing website” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and LinkedIn.

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided KFF Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

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

Stem Cells Can Restore Movement in Paralyzed Patients

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By Pat Anson, PNN Editor

Stem cells derived from body fat can improve sensation and restore movement in patients paralyzed by a severe spinal cord injury, according to a small clinical trial at the Mayo Clinic. One man who was paralyzed from the neck down after a surfing accident is now able to walk again after getting stem cell therapy.

"This study documents the safety and potential benefit of stem cells and regenerative medicine," first author Mohamad Bydon, MD, a Mayo Clinic neurosurgeon, said in a press release. "In spinal cord injury, even a mild improvement can make a significant difference in that patient's quality of life."

The ten patients who participated in the Phase 1 study had adipose (fat) stem calls removed from their abdomen or thigh. After several weeks, 100 million new mesenchymal stem cells (MSCs) grown in a laboratory petri dish were injected into each patient’s lumbar spine. It’s believed the cells then migrate to the injured part of the spine. Participants were regularly followed for the next two years to assess their response to treatment.

The study findings, published in the journal Nature Communications, show that 7 of the 10 patients showed improvement based on the American Spinal Injury Association’s Impairment Scale. Improvements included increased sensation when tested with a pinprick or light touch, increased muscle strength, and the recovery of voluntary bowel function. Three patients showed significant improvement, four had a moderate improvement, and three had no response.

This Mayo Clinic video shows how the process works:

Perhaps the most dramatic improvement was in Chris Barr, a California man who was paralyzed in 2017 while surfing near San Francisco. He broke his neck in eight places when his head hit the ocean floor.

Barr was the first person enrolled in the Mayo study. Eighteen months after the stem cell injection, Barr was able to walk again and continues to show improvement in his mobility and quality of life.

"I never dreamed I would have a recovery like this," Barr told ABC News. "I can feed myself. I can walk around. I can do day-to-day independent activities."  

No serious adverse events were reported from the stem cell treatment. The most common side effects were headaches and musculoskeletal pain that went away after over-the-counter medications were taken.

Since safety is the primary goal of a Phase 1 study, further research will be needed to assess the improvements in movement and sensation. The use of fat-derived stem cells for spinal cord injury is considered experimental by the Food and Drug Administration.

According to the National Spinal Cord Injury Statistical Center, nearly 300,000 Americans currently suffer from a spinal cord injury, costing the healthcare system over $40 billion annually.  The estimated lifetime cost for each patient can reach millions of dollars.

The spinal cord has limited ability to repair itself. Patients who suffer a significant injury typically experience most of their recovery in the first six to 12 months. Improvements generally stop 12 to 24 months after an injury. Only about 5% of people who are paralyzed can expect to regain any feeling or movement.

"For years, treatment of spinal cord injury has been limited to supportive care, more specifically stabilization surgery and physical therapy," Dr. Bydon says. "Many historical textbooks state that this condition does not improve. In recent years, we have seen findings from the medical and scientific community that challenge prior assumptions. This research is a step forward toward the ultimate goal of improving treatments for patients."

Epstein-Barr Virus Emerging As Possible Cause of Chronic Pain

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By Dr. Forest Tennant, PNN Columnist 

When most people hear about the Epstein-Barr virus (EBV), they may recall its reputation as the rather harmless "kissing disease" known as mononucleosis.  To the surprise of many, this previously unheralded virus has recently emerged as a cause of some cancers and painful disorders.

It is now clear that EBV must be contained and suppressed in order to relieve the pain and suffering of many persons with chronic pain. This column is an introduction to the critical involvement of EBV with several chronic pain conditions.

The Epstein-Barr virus is named after Drs. Anthony Epstein and Yvonne Barr. In 1964, they discovered the virus after they found it in a cancer common in Africa called Burkitt’s Lymphoma.  Since that time, EBV has been found to cause other cancers including nasopharyngeal, gastric, Hodgkin’s lymphoma, and leukemia.  Some estimate that EBV causes about 200,000 cancers a year.

About three years after Epstein and Barr discovered EBV, it was found to be the cause of infectuous mononucleosis, which is known to trigger autoimmune complications.  Autoimmunity is simply defined as some element in the body that attacks, erodes, and destroys tissue. 

In 1968, this author reported that mononucleosis could cause glomerulonephritis, an autoimmune renal disease.  Over the ensuing decades, EBV has also been associated with other autoimmune disorders, including hepatitis, rheumatoid arthritis, fibromyalgia, systemic lupus, and Sjogren's syndrome.

EPSTEIN-BARR VIRUS

In 2018, a seminal study documented that EBV could cause a number of painful medical conditions by activating specific genes.  Dr. John Harley and colleagues at Cincinnati Children's Hospital Medical Center, with funding from the National Institutes of Health, found that a viral protein called Epstein-Barr nuclear analog 2 (EBNA 2) binds to the deoxyribonucleic acid (DNA) of genes that promote autoimmunity and some chronic pain conditions.

The pain conditions that Harley and his colleagues associated with EBV are multiple sclerosis, rheumatoid arthritis, celiac disease, type 1 diabetes, inflammatory bowel disease, thyroiditis, and juvenile arthritis.  Subsequent studies added Sjogren's syndrome, mixed connective tissue disease, and polymyositis to the list of EBV autoimmune conditions.

The Harley research is compelling.  We urgently need clinical studies of EBV in severe chronic pain patients to help develop new diagnostic, prevention, and treatment measures.  To this end, I've chosen to study the EBV relationship to painful spine and connective tissue diseases, especially adhesive arachnoiditis (AA) and Ehlers-Danlos syndrome (EDS). These conditions are considered intractable pain conditions in clinical pain practice. 

So far, we have collected EBV laboratory test results from over 80 persons with confirmed AA. Every case has demonstrated abnormally high levels of EBV IgG antibodies, which suggests the presence of autoimmunity and the possible invasion of brain and spinal tissue by the virus. 

Every patient with high IgG antibody levels also has herniated discs, and the majority have hypermobile EDS. Prior to developing AA, all had conditions associated with autoimmunity, such as fibromyalgia and small fiber neuropathy. All of them now have intractable pain.

How It Begins

Patients and clinicians concerned about chronic pain need to understand the basics of how EBV causes and aggravates chronic pain conditions. 

EBV is a member of the herpes virus family, which includes the other herpes viruses and cytomegalovirus.  It is a natural, lifelong parasite that usually infects children before the age of two. 

When EBV first enters the body, it is an “active” virus that may cause a cold, sinusitis, bronchitis, or possibly even go unnoticed. Infants and young children often have the “sniffles” and it could be mistaken as a simple cold. Some children who initially become infected with EBV later develop mononucleosis in their teenage or young adult life.  

After the initial infection, EBV settles into one’s lymphocytes and lining of the throat and nasal cavity to remain for life. Under normal physiologic circumstances, it is a latent or dormant parasite that does no harm.

Over 95% of adults will test positive for low levels of IgG antibodies, decades after their initial contact with EBV during childhood. When chronic pain patients are tested, autoimmunity is suspected if IgG antibodies are above normal levels found in the great majority of adults.

Once EBV has settled into lymphocytes or the throat lining and becomes dormant, it is living a harmless, symbiotic, parasitic life with its human host.  It will remain in this state, unless the body undergoes some kind of stress, usually trauma or an infection, that lowers or degrades the body's innate or natural immunologic protection systems. 

At this time, the virus may vacate its dormant or latent state to begin what is called a "lytic" or duplicative state.  The term used to indicate this state is "reactivation," meaning that the virus is again active, and attacking and invading new tissues. 

Once reactivated, EBV may create an autoimmune state by altering genes or by developing what is called an auto-antibody that will attack tissues.  In either case, an autoimmune state has been created that attacks normal tissues to produce inflammation, adhesions, scarring, and pain. 

Lymphocytes infected with reactivated EBV may enter any number of tissues. They may cross the blood brain barrier, enter the spinal cord and brain, and attack tissues such as the cauda equina, arachnoid membrane, intervertebral discs, and glial cells. This is the pathologic process in which EBV reactivation may cause chronic pain.

It is likely that entry and invasion of spinal canal and brain tissues may be responsible for the autoimmune manifestations seen after a stroke, head trauma, or complex regional pain syndrome (CRPS).  EBV may also be a cause of centralized pain that is associated with over-sensitization, hyperalgesia, and intractable pain.  There are reports that such common chronic pain conditions as fibromyalgia, small fiber neuropathy, and some arthropathies are caused by EBV autoimmunity.

This article's major intent is to inform all concerned parties that deal with chronic pain that EBV is not just some virus that causes the "kissing disease." It is a new revelation that compels an understanding and awareness that has the distinct potential to improve the plight of chronic pain patients. 

Laboratories and clinical researchers, including this author, are scurrying to identify more diagnostic, treatment, and preventive measures for EBV-caused autoimmunity. I'm pleased to report that our EBV project has been able to identify some initial testing and treatment measures which appear to be effective and a good start in dealing with EBV autoimmunity.  We will share our findings in future articles.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its bulletins here.

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

Shortage of Primary Care Doctors a ‘Public Health Crisis’

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By Lynn Arditi, The Public’s Radio

First, her favorite doctor in Providence, Rhode Island, retired. Then her other doctor at a health center a few miles away left the practice. Now, Piedad Fred has developed a new chronic condition: distrust in the American medical system.

“I don’t know,” she said, her eyes filling with tears. “To go to a doctor that doesn’t know who you are? That doesn’t know what allergies you have, the medicines that make you feel bad? It’s difficult.”

At 71, Fred has never been vaccinated against covid-19. She no longer gets an annual flu shot. And she hasn’t considered whether to be vaccinated against respiratory syncytial virus, or RSV, even though her age and an asthma condition put her at higher risk of severe infection.

“It’s not that I don’t believe in vaccines,” Fred, a Colombian immigrant, said in Spanish at her home last fall. “It’s just that I don’t have faith in doctors.”

The loss of a trusted doctor is never easy, and it’s an experience that is increasingly common.

The stress of the pandemic drove a lot of health care workers to retire or quit. Now, a nationwide shortage of doctors and others who provide primary care is making it hard to find replacements. And as patients are shuffled from one provider to the next, it’s eroding their trust in the health system.

The American Medical Association’s president, Jesse Ehrenfeld, recently called the physician shortage a “public health crisis.”

“It’s an urgent crisis, hitting every corner of this country, urban and rural, with the most direct impact hitting families with high needs and limited means,” Ehrenfeld told reporters in October.

In Fred’s home state of Rhode Island, the percentage of people without a regular source of routine health care increased from 2021 to 2022, though the state’s residents still do better than most Americans.

Hispanic residents and those with less than a high school education are less likely to have a source of routine health care, according to the nonprofit organization Rhode Island Foundation.

Shrinking Workforce

The community health centers known as federally qualified health centers, or FQHCs, are the safety net of last resort, serving the uninsured, the underinsured, and other vulnerable people. There are more than 1,400 community health centers nationwide, and about two-thirds of them lost between 5% and a quarter of their workforce during a six-month period in 2022, according to a report by the National Association of Community Health Centers.

Another 15% of FQHCs reported losing between a quarter and half of their staff. And it’s not just doctors: The most severe shortage, the survey found, was among nurses.

In a domino effect, the shortage of clinicians has placed additional burdens on support staff members such as medical assistants and other unlicensed workers.

Their extra tasks include “sterilizing equipment, keeping more logs, keeping more paperwork, working with larger patient loads,” said Jesse Martin, executive vice president of District 1199 NE of the Service Employees International Union, which represents 29,000 health care workers in Connecticut and Rhode Island.

“When you add that work to the same eight hours’ worth of a day’s work you can’t get everything done,” Martin said.

Last October, scores of SEIU members who work at Providence Community Health Centers, Rhode Island’s largest FQHC, held an informational picket outside the clinics, demanding improvements in staffing, work schedules, and wages.

The marketing and communications director for PCHC, Brett Davey, declined to comment.

Staff discontent has rippled through community health care centers across the country. In Chicago, workers at three health clinics held a two-day strike in November, demanding higher pay, better benefits, and a smaller workload.

Then just before Thanksgiving at Unity Health Care, the largest federally qualified health center in Washington, D.C., doctors and other medical providers voted to unionize. They said they were being pressed to prioritize patient volume over quality of care, leading to job burnout and more staff turnover.

The staffing shortages come as community health centers are caring for more patients. The number of people served by the centers between 2015 and 2022 increased by 24% nationally, and by 32.6% in Rhode Island, according to the Rhode Island Health Center Association, or RIHCA.

“As private practices close or get smaller, we are seeing patient demand go up at the health centers,” said Elena Nicolella, RIHCA’s president and CEO. “Now with the workforce challenges, it’s very difficult to meet that patient demand.”

In Rhode Island, community health centers in 2022 served about 1 in 5 residents, which is more than twice the national average of 1 in 11 people, according to RIHCA.

Job vacancy rates at Rhode Island’s community health centers are 21% for physicians, 18% for physician assistants and nurse practitioners, and 10% for registered nurses, according to six of the state’s eight health centers that responded to a survey conducted by RIHCA for The Public’s Radio, NPR, and KFF Health News.

Pediatricians are also in short supply. Last year, 15 pediatricians left staff positions at the Rhode Island health centers, and seven of them have yet to be replaced.

Research shows that some of the biggest drivers of burnout are workload and job demands.

Community health centers tend to attract clinicians who are mission-driven, said Nelly Burdette, who spent years working in health centers before becoming a senior leader of the nonprofit Care Transformation Collaborative of Rhode Island.

These clinicians often want to give back to the community, she said, and are motivated to practice “a kind of medicine that is maybe less corporate,” and through which they can they develop close relationships with patients and within multigenerational families.

So when workplace pressures make it harder for these clinicians to meet their patients’ needs, they are more likely to burn out, Burdette said.

‘I Can’t Get an Appointment’

When a doctor quits or retires, Carla Martin, a pediatrician and an internist, often gets asked to help. The week before Thanksgiving, she was filling in at two urgent care clinics in Providence.

“We’re seeing a lot of people coming in for things that are really primary care issues, not urgent care issues, just because it’s really hard to get appointments,” Martin said.

One patient recently visited urgent care asking for a refill of her asthma medication. “She said, ‘I ran out of my asthma medicine, I can’t get a hold of my PCP for refill, I keep calling, I can’t get through,’” Martin said.

Stories like that worry Christopher Koller, president of the Milbank Memorial Fund, a nonprofit philanthropy focused on health policy. “When people say, ‘I can’t get an appointment with my doctor,’ that means they don’t have a usual source of care anymore,” Koller said.

Koller points to research showing that having a consistent relationship with a doctor or other primary care clinician is associated with improvements in overall health and fewer emergency room visits.

When that relationship is broken, patients can lose trust in their health care providers.

That’s how it felt to Piedad Fred, the Colombian immigrant who stopped getting vaccinated. Fred used to go to a community health center in Rhode Island, but then accessing care there began to frustrate her.

She described making repeated phone calls for a same-day appointment, only to be told that none were available and that she should try again tomorrow. After one visit, she said, one of her prescriptions never made it to the pharmacy.

And there was another time when she waited 40 minutes in the exam room to consult with a physician assistant — who then said she couldn’t give her a cortisone shot for her knee, as her doctor used to do.

Fred said that she won’t be going back. What will she do the next time she gets sick or injured and needs medical care?

“Well, I’ll be going to a hospital,” she said in Spanish.

But experts warn that more people crowding into hospital emergency rooms will only further strain the health system, and the people who work there.

This article is from a partnership that includes The Public’s Radio, NPR, and KFF Health News, a national newsroom that produces in-depth journalism about health issues.

Does Netflix Trivialize Pain?

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By Pat Anson, PNN Editor

Movies and TV shows have long been criticized for the way they depict women, minorities and religions -- either through sensationalism, stereotyped portrayals, or simply omission.

A new analysis of popular programs that aired on Netflix suggests that physical pain is also being ignored, trivialized, or presented in misleading ways.

Researchers in Canada and the UK looked at over a dozen movies and TV series that featured teenage characters. They found that the teens’ pain was almost always the result of violence or accidents – not common medical conditions such as migraine or menstruation. The characters often had minimal reactions to their own pain and observers had “an overwhelming lack of empathy” for them.   

“If we’re not showing the types of pain that adolescents might typically experience like back pain and menstrual pain, then we’re trivializing pain. We’re not doing a great job of enabling them to think about how to manage pain, how to talk about pain and how to show empathy when other people experience pain,” said lead author Abbie Jordan, PhD, a lecturer in the Department of Psychology and Centre for Pain Research at The University of Bath.

“This research matters because if every film and television series shows a boy being a ‘tough guy’ when they experience pain and a girl as a ‘damsel in distress’ in need of saving, they might think they have to be like that in real life. This depiction reinforces old-fashioned ideas about gender and is misleading."

Jordan and her colleagues watched programs such as Sex Education, Stranger Things and Enola Holmes, and found that viewers were exposed to an average of 10 incidents of pain every hour.

The two Netflix shows with the highest number of painful incidents were Outer Banks, a series about teens searching for a hidden treasure, and Spiderman: Homecoming, a movie about a young Peter Parker facing off against a new villain.

Violence (57%) was the most likely cause of pain on the Netflix shows, followed by everyday pain such as headaches (21%) and pain stemming from injuries (20%). Chronic pain or pain resulting from medical procedures were depicted less than one percent of the time.

“‘OUTER BANKS”

Researchers say the Netflix shows often reinforced sexist and patriarchal stereotypes. Boy characters were more likely to experience pain (77%) than girls (23%), and they were also more likely to be criticized or laughed at by other characters. Boys were often portrayed as heroic figures coming to the rescue, while girls were more emotional when reacting to pain.   

The plots and characters are all fictional, but researchers say adolescents watching at home are likely to mirror the behavior themselves.  

“Media is one of the most powerful engines of influence on children’s development and could be harnessed to address pain and suffering in the world. Stories matter. Fictional stories can matter more in some cases than real-life stories. So, let's create stories to reflect the world we want to see: A humane, diverse, inclusive, equitable, compassionate, and caring world,” says co-author Melanie Noel, PhD, an Associate Professor of Clinical Psychology at the University of Calgary.

“I want Netflix to take this seriously and get excited and inspired to directly influence millions of children around the world. They have a monumental opportunity to influence the compassion and humanity we see in our children and our future world.”

The study findings, published in the journal PAIN, echo a previous study that showed pain was trivialized for even younger children (aged 4-6 years). That study also showed that chronic pain in childhood and adolescence was rarely portrayed in popular media.

Physical Activity Can Protect Against Chronic Pain

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By Pat Anson, PNN Editor

Chronic pain sufferers are often told that physical activity and exercise can help reduce pain and improve quality of life. Now there is evidence that even light or moderate activity can have a protective effect against pain that lasts for years.

“We found that people who were more active in their free time had a lower chance of having various types of chronic pain 7-8 years later,” says Anders Årnes, a doctoral fellow at The Arctic University of Norway and University Hospital of North Norway.

“This suggests that physical activity increases our ability to tolerate pain and may be one of the ways in which activity helps to reduce the risk of developing severe chronic pain.”

Årnes is the lead author of a study, recently published in the journal PAIN, that found even light physical activity was associated with a 5% lower risk of developing chronic pain that lasts at least three months. More rigorous activity was associated with a 16% reduced risk of widespread moderate-to-severe chronic pain.

The findings are based on data from a large health survey -- the Tromsø Study --- in which over 6,800 Norwegians answered questions about their overall health, pain levels and physical activity, first in 2007-2008 and then again in 2015-2016. The average age of participants was nearly 55. Most reported some form of chronic pain, but only 5% had widespread moderate-to-severe chronic pain.

In a 2023 analysis of the survey data, Årnes and his colleagues found that people who reported vigorous physical activity had significantly more pain tolerance than those with a sedentary lifestyle.

Pain tolerance was assessed by how long they could keep a hand immersed in cold water that was a few degrees above freezing (3 degrees Celsius or 37.4 degrees Fahrenheit).

In their new follow-up study, researchers found that the ability to tolerate pain – or at least cold water -- plays a modest role in the protective effect of physical activity (PA).  

Stina Grønbech/Tromsøundersøkelsen

“We estimate that higher PA levels predict lower risk of chronic pain, with indications of a small mediated effect on this risk through cold pain tolerance for moderate-to-severe chronic pain states,” researchers reported.

Of course, many people with severe chronic pain are unable to exercise or fear that it will only make their pain worse. Previous studies have found that low-impact exercise programs, such as stretching while sitting in a chair, can ease pain from arthritis and other muscle and joint conditions.

“Physical activity is not dangerous in the first place, but people with chronic pain can benefit greatly from having an exercise program adapted to help them balance their effort so that it is not too much or too little,” said Årnes. “A rule of thumb is that there should be no worsening that persists over an extended period of time, but that certain reactions in the time after training can be expected.”

Even moderate physical activity can stimulate the production of endorphins and endocannabinoids – hormones and lipids naturally produced by the body -- which can relieve pain and inflammation. Regular exercise can also help us lose weight, reduce the risk of heart disease, and boost overall health.  

Finding Medical Care Can Be Exhausting for Seniors

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By Judith Graham, KFF Health News

Susanne Gilliam, 67, was walking down her driveway to get the mail in January when she slipped and fell on a patch of black ice. Pain shot through her left knee and ankle. After summoning her husband on her phone, with difficulty she made it back to the house.

And then began the run-around that so many people face when they interact with America’s uncoordinated health care system.

Gilliam’s orthopedic surgeon, who managed previous difficulties with her left knee, saw her that afternoon but told her “I don’t do ankles.”

He referred her to an ankle specialist who ordered a new set of X-rays and an MRI. For convenience’s sake, Gilliam asked to get the scans at a hospital near her home in Sudbury, Massachusetts. But the hospital didn’t have the doctor’s order when she called for an appointment. It came through only after several more calls.

Coordinating the care she needs to recover, including physical therapy, became a part-time job for Gilliam. (Therapists work on only one body part per session, so she has needed separate visits for her knee and for her ankle several times a week.)

“The burden of arranging everything I need — it’s huge,” Gilliam told me. “It leaves you with such a sense of mental and physical exhaustion.”

The toll the American health care system extracts is, in some respects, the price of extraordinary progress in medicine. But it’s also evidence of the poor fit between older adults’ capacities and the health care system’s demands.

“The good news is we know so much more and can do so much more for people with various conditions,” said Thomas H. Lee, chief medical officer at Press Ganey, a consulting firm that tracks patients’ experiences with health care. “The bad news is the system has gotten overwhelmingly complex.”

Multiple Doctors Visits

That complexity is compounded by the proliferation of guidelines for separate medical conditions, financial incentives that reward more medical care, and specialization among clinicians, said Ishani Ganguli, an associate professor of medicine at Harvard Medical School.

“It’s not uncommon for older patients to have three or more heart specialists who schedule regular appointments and tests,” she said. If someone has multiple medical problems — say, heart disease, diabetes, and glaucoma — interactions with the health care system multiply.

Ganguli is the author of a new study showing that Medicare patients spend about three weeks a year having medical tests, visiting doctors, undergoing treatments or medical procedures, seeking care in emergency rooms, or spending time in the hospital or rehabilitation facilities. (The data is from 2019, before the covid pandemic disrupted care patterns. If any services were received, that counted as a day of health care contact.)

That study found that slightly more than 1 in 10 seniors, including those recovering from or managing serious illnesses, spent a much larger portion of their lives getting care — at least 50 days a year.

“Some of this may be very beneficial and valuable for people, and some of it may be less essential,” Ganguli said. “We don’t talk enough about what we’re asking older adults to do and whether that’s realistic.”

Victor Montori, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, has for many years raised an alarm about the “treatment burden” that patients experience. In addition to time spent receiving health care, this burden includes arranging appointments, finding transportation to medical visits, getting and taking medications, communicating with insurance companies, paying medical bills, monitoring health at home, and following recommendations such as dietary changes.

Overwhelmed Patients

Four years ago — in a paper titled “Is My Patient Overwhelmed?” — Montori and several colleagues found that 40% of patients with chronic conditions such as asthma, diabetes, and neurological disorders “considered their treatment burden unsustainable.”

When this happens, people stop following medical advice and report having a poorer quality of life, the researchers found. Especially vulnerable are older adults with multiple medical conditions and low levels of education who are economically insecure and socially isolated.

Older patients’ difficulties are compounded by medical practices’ increased use of digital phone systems and electronic patient portals — both frustrating for many seniors to navigate — and the time pressures afflicting physicians.

“It’s harder and harder for patients to gain access to clinicians who can problem-solve with them and answer questions,” Montori said.

Meanwhile, clinicians rarely ask patients about their capacity to perform the work they’re being asked to do.

“We often have little sense of the complexity of our patients’ lives and even less insight into how the treatments we provide (to reach goal-directed guidelines) fit within the web of our patients’ daily experiences,” several physicians wrote in a 2022 paper on reducing treatment burden.

Consider what Jean Hartnett, 53, of Omaha, Nebraska, and her eight siblings went through after their 88-year-old mother had a stroke in February 2021 while shopping at Walmart. At the time, the older woman was looking after Hartnett’s father, who had kidney disease and needed help with daily activities such as showering and going to the bathroom.

During the year after the stroke, both of Hartnett’s parents — fiercely independent farmers who lived in Hubbard, Nebraska — suffered setbacks, and medical crises became common. When a physician changed her mom’s or dad’s plan of care, new medications, supplies, and medical equipment had to be procured, and new rounds of occupational, physical, and speech therapy arranged.

Neither parent could be left alone if the other needed medical attention.

“It wasn’t unusual for me to be bringing one parent home from the hospital or doctor’s visit and passing the ambulance or a family member on the highway taking the other one in,” Hartnett explained. “An incredible amount of coordination needed to happen.”

Hartnett moved in with her parents during the last six weeks of her father’s life, after doctors decided he was too weak to undertake dialysis. He passed away in March 2022. Her mother died months later in July.

Easing the Healthcare Burden

So, what can older adults and family caregivers do to ease the burdens of health care?

To start, be candid with your doctor if you think a treatment plan isn’t feasible and explain why you feel that way, said Elizabeth Rogers, an assistant professor of internal medicine at the University of Minnesota Medical School. 

“Be sure to discuss your health priorities and trade-offs: what you might gain and what you might lose by forgoing certain tests or treatments,” she said. Ask which interventions are most important in terms of keeping you healthy, and which might be expendable.

Doctors can adjust your treatment plan, discontinue medications that aren’t yielding significant benefits, and arrange virtual visits if you can manage the technological requirements. (Many older adults can’t.)

Ask if a social worker or a patient navigator can help you arrange multiple appointments and tests on the same day to minimize the burden of going to and from medical centers. These professionals can also help you connect with community resources, such as transportation services, that might be of help. (Most medical centers have staff of this kind, but physician practices do not.)

If you don’t understand how to do what your doctor wants you to do, ask questions: What will this involve on my part? How much time will this take? What kind of resources will I need to do this? And ask for written materials, such as self-management plans for asthma or diabetes, that can help you understand what’s expected.

“I would ask a clinician, ‘If I chose this treatment option, what does that mean not only for my cancer or heart disease, but also for the time I’ll spend getting care?’” said Ganguli of Harvard. “If they don’t have an answer, ask if they can come up with an estimate.”

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

Keeping Hope Alive

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By Mia Maysack, PNN Columnist

In 2022, I was fortunate enough to receive the International Pain Foundation's “Hero of Hope”' award for patient advocacy. I felt and still feel remarkably honored for the recognition, although I am not motivated by any accolade or prestige. I fight for those who can't. I use my voice so others can be heard.

As a patient advocate, I’ve learned the absolute most important thing that I can do is rescue myself – repeatedly. If I don't make it and I'm no longer here, what good can I do or offer to anybody else?

Recently, I've struggled immensely. There have been moments that haven't felt survivable. I sought support, reached out for help, attended therapy, and tried endless lifestyle approaches with little to no progress in how I feel.

It is important for me to express this publicly because I want to drive the point home: An optimistic perspective alone is not enough for survival. You can seek out the bright side, acknowledge how things could always be worse, recognize all your blessings, and be grateful for them -- yet still suffer immensely.

I reached out to someone to vent some of this, in what I'd hoped would be a receptive and safe space. But I was quickly reminded of the extent to which people simply don't know how to navigate others' hardships or struggles.

“I'm having a rough time,” I said.

“Maybe you need to go to counseling,” they replied.

“I tried that again recently. But my medical trauma is extensive. It did not help and actually worsened things for me."

[insert awkward silence here]

"Ordinarily,” I continued, “I’d pour myself into other causes, things, and people. That usually helps, but I am struggling with energy and motivation.”

“Sounds like depression,” they said.

“Depression isn’t new to me,” I explained. “Coping with daily ailments isn’t something that everyone can bear. Depression in these instances occurs by default. It’s an underlying current underneath the symptoms, constantly demanding my attention and effort to accommodate and manage it.”

"I think you need to pour into yourself,” was their reply.

"I have, extensively. But it is as though I'm a cracked cup and it all leaks out,” I said.

[insert another awkward silence]

At this point, I can sense they are uncomfortable, so I rush to ease their pain as mine intensifies. And I’m reminded how there’s just about nowhere for us to turn where we can be adequately received or understood.

“But I will figure it out, I always do,” I declared, tears running down my cheeks.

"Now that's the spirit!” they proclaimed.

I’ve always possessed “spirit” but sometimes it’s not enough. This is why I have such a profound empathy for those who idealize or even follow through on ending life. I see and understand how and to what extent we reach out for help, yet I'm repeatedly reminded that we're ultimately left on our own -- by each other, by our systems, and by society as a whole.

No one wants you to end your existence, yet almost nothing and no one is there to contribute meaningfully to your quality of life.

In observation of this and because I strongly believe in cultivating solutions -- as opposed to fixating on problems – I’m supporting efforts by the American Foundation for Suicide Prevention to raise awareness and talk about how we can prevent suicide and increase access to mental healthcare.

The darkness in me honors yours. It's not only okay, but profoundly necessary to allow that part of ourselves to exist out loud. It’s the only way through to the light. 

I imagine a future where we don't have to beg and plead for basic human needs, and we’re no longer alone in attempting to figure it all out.  This vision keeps me going and keeps the fire of hope alive.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is a healthcare reform advocate and founder of Keepin’ Our Heads Up, a support network; Peace & Love, a life coaching practice; and Still We Rise, an organization that seeks to alleviate pain of all kinds.

For anyone thinking about suicide, please contact the 988 Suicide & Crisis Lifeline, available online, via chat, or by dialing “988.”  A comprehensive set of resources can also be found at this link.

Study Finds CBD Ineffective for Chronic Pain  

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By Pat Anson, PNN Editor

There is little evidence that cannabidiol (CBD) products relieve chronic pain and some could be potentially harmful to patients, according to UK and Canadian researchers.

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Often marketed as a pain reliever, CBD can be purchased in edibles, beverages, lotions, oils and other products, usually without a prescription.  

“CBD presents consumers with a big problem,” says lead author Chris Eccleston, PhD, Professor of Pain Science at the University of Bath in the UK. “It’s touted as a cure for all pain but there’s a complete lack of quality evidence that it has any positive effects.

“There should be no excuses for misleading the public, and yet it is likely that the public is being misled and possibly placed in harm’s way.”

Eccleston and his colleagues reviewed the results of 16 high-quality clinical trials of CBD products, involving over 900 participants. Their findings, published in in The Journal of Pain, show that CBD provided little or no pain relief in 15 of the 16 studies. The one small trial that did showed improvement in arthritis pain after two weeks of treatment with a topical CBD lotion.

Just as concerning to researchers is that many CBD products sold directly to consumers have significantly more or less CBD than what their labels indicate. Some CBD products also contain THC, when they weren’t supposed to have any.

“There is no good reason for thinking that CBD relieves pain, but there are good reasons for doubting the contents of CBD products in terms of CBD content and purity,” Eccleston wrote. “Regulatory authorities should also take note of the considerable deficiencies existing in the products sold, especially the incorrect labeling of many products, and possible contamination with psychoactive compounds.”

The researchers say regulators in the US, UK and Canada are often slow to respond to the false medical claims of some CBD manufacturers. The FDA occasionally sends warning letters to companies making unsubstantiated claims about CBD, but it rarely results in fines or disciplinary action.

“What this means is that there are no consumer protections,” said co-author Dr Andrew Moore, Director of Pain Research at the University of Oxford. “And without a countervailing body to keep the CBD sellers in check, it’s unlikely that the false promises being made about the analgesic effects of CBD will slow down in the years ahead.”

In a recent review, the FDA said there was “credible scientific support” for cannabis as a pain reliever and recommended that the DEA reschedule it as a Schedule III controlled substance. Such a move would make it legal under federal law for cannabis to be prescribed for medically approved conditions, but would have no impact on CBD products.

In 2022, FDA Commissioner Dr. Robert Califf asked Congress to give his agency the authority to more closely regulate CBD, but no such legislation has been passed. Eccleston says its part of a pattern in which pain sufferers are neglected and left on their own to find relief.

“It’s almost as if chronic pain patients don’t matter, and that we’re happy for people to trade on hope and despair,” he said.

A Third of Independent Pharmacies May Close

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By Pat Anson, PNN Editor

These are tough times for many retail pharmacies and their customers. Big chain pharmacies like CVS, Walgreens and Rite Aid are closing over 1,500 stores, as they grapple with declining sales, higher debt, drug shortages, fallout from opioid litigation, and an overworked, demoralized workforce.

For many patients who had trouble getting their prescriptions filled for opioids and other controlled substances, small independent pharmacies became a welcome refuge from the big chains.

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” one patient told us.

But now even the independent pharmacies are threatened. About a third of them could close in 2024, according to a dire prediction from the National Community Pharmacists Association (NCPA), a trade group that represents nearly 20,000 independent pharmacy owners in the U.S.

“Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” says B. Douglas Hoey, RPh, NCPA’s CEO.

At issue is a new rule by the Centers for Medicare & Medicaid Services (CMS) that requires insurers and pharmacy benefit managers (PBMs) to implement discounts and price concessions at the point of sale, where a drug is dispensed. The rule is intended to make pricing more transparent for patients, but it’s hurting the bottom line of pharmacies who say the discounts are being unfairly forced on them by insurers.

Part D Prescriptions at Risk

In a recent survey of NCPA members, 32% said they may have to close by the end of the year due to the CMS rule and 93% said they’d consider dropping out of Medicare’s Part D prescription drug program. Most say they are losing money on Part D prescriptions, which don’t compensate the pharmacies for rent, taxes, payroll and other costs of doing business.

“Cash flow for many pharmacies remains in a precarious state, leading to dire concerns for beneficiary access. Our members continue to experience significant harm from egregious Medicare Part D PBM practices,” Hoey wrote in a letter to CMS, which faulted the agency for doing little to stop the PBMs.

Asked which PBMs are causing the most financial stress in the Part D program, almost half the NCPA members identified Express Scripts, with CVS/Caremark coming in at 35 percent.

Hoey says CMS already has the legal authority to change reimbursement practices, but wants Congress to intervene if CMS doesn’t act soon.

“This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy,” Hoey said in a statement.

NCPA says there are about 2,200 fewer retail pharmacies today than there were four years ago. This has created hundreds of pharmacy “deserts,” primarily in low-income rural and urban areas, where access to a pharmacy is limited or non-existent. Alabama alone has lost 300 pharmacies in recent years.

“With every closure, 5,000 Alabamians are left without a critically important health care provider. This is a major issue for every community in our state, but rural Alabama is hit the hardest. In many cases, that local pharmacy is the only healthcare provider in that rural community,” Alabama State Rep. Phillip Rigsby, a pharmacist, wrote in an op/ed published in AL.com.

“In other businesses, if an operating cost increases, the company’s prices increase to compensate. In pharmacy, that just is not possible. A pharmacy cannot pass on that cost to a patient because the contract doesn’t allow for that.”

Can Naproxen Help You Live Longer?

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By Pat Anson, PNN Editor

There may be a hidden benefit to the pain reliever naproxen. The non-steroidal anti-inflammatory drug (NSAID) is primarily used to treat arthritis, muscle aches and joint pain, but might also give a boost to your life expectancy, according to the results of a preliminary study.

An international research team analyzed 12-years of health records for over 500,000 people enrolled in the UK Biobank study to see if prescription drugs taken for at least 3 months were associated with higher or lower death rates. Over 400 medications were studied, with patients who were prescribed the drugs compared to control groups that didn’t take them.

“As expected, most drugs harbor a negative effect on lifespan, probably due to the underlying negative effect of the disease the drug is intended for. Importantly, a few drugs seem to have a beneficial effect on lifespan,” wrote lead author Alejandro Ocampo, PhD, a professor at the University of Lausanne and CEO of Epiterna, a Swiss company studying ways to slow the ageing process.        

Ocampo and his colleagues identified four medications associated with lower death rates:

  • Naproxen   

  • Atorvastatin (a statin)

  • Estradiol (female hormone replacement)

  • Sildenafil (Viagra)

Statins have long been known to reduce the risk of heart attack and stroke, while estradiol lowers the risk of osteoporosis and bone fractures in post-menopausal women. Sildenafil is well known for treating erectile dysfunction, but also improves cardiovascular health and may even protect against Alzheimer's disease. It’s easy to see how those drugs might increase life expectancy.

The inclusion of naproxen is a bit of a surprise. The active ingredient in Aleve and other over-the-counter pain relievers, naproxen raises the risk of a heart attack, stroke or internal bleeding when taken in high doses or used long-term. High doses of naproxen in 250mg and 500mg tablets are available by prescription, which is what people in the study were taking.

Even at those high doses, researchers found that naproxen was associated with a 10% lower death rate when compared to people who didn’t take the drug. The protective effect was strongest for men on naproxen, who had mortality rates that were 13% lower.

The findings are preliminary, have not been peer-reviewed, and don’t establish a cause-and-effect relationship. We don’t know why or how naproxen helps people live longer, only that it’s associated with a longer lifespan.  

Interestingly, the research team found that two other pain relievers – morphine and paracetamol (acetaminophen) – are associated with shorter lifespans. Again, this may have more to do with the underlying conditions the drugs were prescribed for, rather than the medications themselves.

Ocampo says more research and clinical studies are needed to get a better understanding of the long-term harms and benefits of medication.

“The benefit on lifespan observed for several drugs in this retrospective study could only be truly determined by performing randomized controlled trials. Such studies would aim at treating a healthy aging population with a drug during a sufficiently long follow-up to be able to observe the effect on all-cause mortality,” Ocampo wrote.

If the life expectancy benefits are proven, researchers say it could result in some drugs being “repurposed” as anti-aging treatments for otherwise healthy older adults.

Naltrexone Shortage Disrupts Addiction Treatment

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By Pat Anson, PNN Editor

An inexpensive drug used to manage chronic pain and treat substance use disorders has joined the growing list of medications that are in short supply in the United States.

The Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) both recently added naltrexone tablets to their drug shortage lists. It’s not clear what caused the shortage, but the ASHP says “there is insufficient supply for usual ordering.”  

Naltrexone is FDA-approved to treat both alcohol and opioid use disorder, and is also used off-label in low doses to treat some chronic pain conditions.

In 50mg doses, naltrexone blocks opioid receptors in the brain and reduces cravings for opiates or alcohol. But in smaller doses of 5mg or less, patients have found low-dose naltrexone (LDN) to be an effective pain reliever for interstitial cystitis, Ehlers-Danlos syndrome, fibromyalgia, and other painful conditions.

LDN advocates believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller. Because it is an opioid antagonist, naltrexone should not be taken with opioid medication.

So far, the shortage only affects 50mg naltrexone tablets. Pain patients usually obtain LDN by prescription from compounding pharmacies, which make the low dose versions in-house.

Several drug makers are reporting short supplies of 50mg tablets, including Accord Healthcare, Major, Elite Laboratories, SpecGx, Sun Pharma, Tagi Pharma, and Avet Pharmaceuticals. The companies didn’t provide the ASHP with a reason for the shortage, but said the tablets are on back order and would be released when they become available.    

The naltrexone shortage comes at an inopportune time, as more people abused alcohol and other substances during the pandemic and sought treatment. The drug that helps them stay sober is now hard to get.

"People are coming in with more cravings," Dr. Aviva Zohar, an addiction medicine provider, told Philly Voice. "Even the feeling of, 'I don't know when my medicine is coming in,' is a huge struggle. It's horrific (and) causing a lot of stress.”

To make up for the shortage, some providers are giving patients Vivitrol, an injectable, extended-release formulation of naltrexone taken once a month. A single Vivitrol injection costs about $1,700, while a month’s supply of 50mg naltrexone tablets costs about $48.

The cheap price of naltrexone may be responsible for the shortage. Most drugs in short supply are low-cost generics with slim profit margins. Some manufacturers have reduced or stopped making generics because they’re not worth the cost of production or the risk of litigation.   

Three generic opioids commonly taken for pain — immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets — have been on the ASHP shortage list for nearly a year, with no end in sight.