90% of Pain Patients Have Trouble Filling Opioid Prescriptions

By Pat Anson, PNN Editor

Nine out of ten pain patients with an opioid prescription in the United States experienced delays or problems in the past year getting their prescription filled at a pharmacy, according to a large new survey by Pain News Network.  Nearly 20% of patients were not able to get their opioid medication, even after contacting multiple pharmacies.

Over 2,800 pain patients participated in PNN’s online survey. Many were so frustrated with pharmacists being unable or unwilling to fill their opioid prescriptions that they turned to other substances for pain relief or contemplated suicide.

“My medication helps my pain be at a level I can tolerate. When I can't get it, I honestly feel like ending my life due to the pain. I wish they'd stop to realize there are those of us with a legitimate need,” one patient told us.

“The discrimination we receive, not to mention all the hurdles we are put through just being a chronic pain patient, is absolutely affecting my physical, mental, and emotional health. It’s only gotten worse, leaving myself and family to scramble looking for medication,” another patient said.

“The problem I've had this year is my pharmacy running out of my pain meds. Then it's a frantic and anxiety filled race to find one that will,” another patient wrote. “My regular medication has been Percocet for years and I haven't received that in almost a year. No pharmacies in this area have been able to get it.”

DID YOU EXPERIENCE DELAYS OR PROBLEMS GETTING YOUR OPIOID PRESCRIPTION FILLED AT A PHARMACY?

The U.S. is currently experiencing its worst drug shortages in a decade, with supplies running low for medications used to treat cancer, ADHD and diabetes. Less publicized are chronic shortages of oxycodone, hydrocodone and other opioids used to treat pain – shortages that that have gotten little, if any, attention from the White House, Congress, or federal health agencies like the CDC and FDA.  

While supply chain issues and low profit margins for generic medication are driving many of the drug shortages, the low supply of opioids is largely the result of policy and political decisions. Egged on by Congress, the DEA for eight straight years has cut opioid production quotas, reducing the supply of many opioids by over two-thirds in a failed attempt to bring the overdose crisis under control.

Opioid litigation has also played a major role in the shortages, with drug wholesalers and big pharmacy chains agreeing to limit the supply of opioids at each individual pharmacy as part of the $21 billion national opioid settlement.

Whatever the cause, American pain patients routinely run into problems when they try to get an opioid prescription filled. Nearly 85% said they were told by a pharmacist that their medication is temporarily out of stock, while 6% were told there is only enough to partially fill the prescription.

What was primary reason the pharmacist gave for not filling the prescription?

• 85% Opioid medication not in stock

• 6% Can only make partial fills

• 4% Insurance issue

• 3% Did not explain why

• 2% Might get in trouble or lose their job

• 1% Prescription too risky or inappropriate

Some pharmacists said they might get in trouble or lose their job if they filled the prescription, while others claimed the medication was inappropriate, too risky, or that there was an insurance issue. Many gave multiple excuses to patients.

“First it was that they didn’t have the full quantity in stock. They then tried to get me to take a partial fill, then they told me they needed a prescription for Narcan from the prescribing doctor, and then out of nowhere it’s not covered by my insurance,” one patient wrote.

“Pharmacy said that there were shortages everywhere and had no idea when they would have the oxycodone that I need daily for my lower back pain,” said another.

“Pharmacist stated that the medication was on back order. They also said that they don't know if they will ever get them back again,” a patient wrote.

“At first the pharmacist said both scripts were out of stock, then he said he could only do a partial fill. Then told me he couldn't fill my scripts anymore and to find a new pharmacy,” another frustrated patient explained.

Over 60% of patients did just that, by visiting or calling another pharmacy. That’s not as easy as it may sound. Over half said they contacted three or more pharmacies while trying to get their prescription filled.

Many were turned away, as pharmacies are often reluctant to take on new pain patients because that would make their rationed supply of opioids even tighter.  

“They had it in stock one month but the next month she told me she had to save them for her regular customers. Then she went on to say that Walgreens will no longer accept people with no insurance,” a patient wrote.

DID YOU HAVE TO FIND ANOTHER PHARMACY TO FILL THE PRESCRIPTION?

“Getting my monthly pain pills is a 3 ring circus joke. It takes 10 to 15 days of making calls covering 175 miles to make sure I can pick them up!” said another.

“CVS is only allowed so many hydrocodone a month and if my prescription doesn't get in ahead of somebody else's I'm screwed,” said a patient who lives with pain from fibromyalgia and osteoporosis. “Without it I am bed-bound and have to basically cry and crawl to the bathroom and back to bed.”

“The pharmacies try their best to fill your prescription, but if they don't have it in stock, they don't have it in stock,” another patient wrote. “It definitely affects the quality of life. You live in fear every month that this is going to be it.”

WERE YOU EVENTUALLY ABLE TO GET THE PRESCRIPTION FILLED?

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,826 U.S. pain patients or caregivers with an opioid prescription participated. We’ll be releasing more results in the coming days.  

Patients With Irritable Bowel Syndrome Have High Rates of Fibromyalgia

By Pat Anson, PNN Editor

A large new study has found high rates of fibromyalgia in patients with irritable bowel syndrome (IBS), adding to a growing body of evidence linking gut bacteria to chronic pain disorders. IBS patients were also more likely to have chronic fatigue syndrome (CFS).

The study, recently published in the journal Biomedicines, looked at more than 1.2 million IBS patients hospitalized in the U.S. over a three-year period. They found that the prevalence rate of fibromyalgia in the IBS patients was 10.7 percent, about five times higher than the fibromyalgia rate (1.4%) in the general adult population.

Fibromyalgia is a poorly understood condition characterized by widespread body pain, headaches, fatigue, insomnia and mood disorders; while IBS causes abdominal pain, cramps, bloating, gas and diarrhea. Gut bacteria has been associated with both IBS and fibromyalgia, but the exact mechanism of action remains unclear.

“This is yet another example where ailments in the gut are linked to ailments elsewhere in the body and mind,” said senior author Yezaz Ghouri, MD, an assistant professor of clinical medicine and gastroenterology at the University of Missouri School of Medicine. “As we continue to learn more about how gut health effects health elsewhere it is important that clinicians look for and manage somatic comorbidities in IBS patients.”

Fibromyalgia and CFS are known as “somatic” disorders because patients who have them often experience anxiety and depression – a tendency perhaps explained about the lack of effective treatments for their physical symptoms.

“Because IBS patients have higher prevalence of somatic comorbidities such as fibromyalgia and chronic fatigue syndrome, identifying and treating these disorders can improve their quality of life,” said lead researcher Zahid Ijaz Tarar, MD, a fellow in the division of gastroenterology and hepatology at the University of Missouri School of Medicine.

“Earlier identification of comorbidities is valuable to inform treatment strategies, including consulting other specialties such as rheumatology and psychiatry to improve the overall health outcomes in IBS patients.”

In addition to fibromyalgia, the research team found that hospitalized IBS patients were also significantly more likely to be white and female.  Less than one percent (0.42%) had a CFS diagnosis – a small percentage to be sure, but still higher than CFS rates in the general population (0.06%).

The high rates of fibromyalgia and CFS in IBS patients has led to speculation that poor diets or antibiotics may cause an imbalance of “bad” bacteria in the gastrointestinal system, allowing toxins to leak into the bloodstream and cause other health problems.

A recent study found that Klebsiella aerogenes, a bacterium that causes white blood cells to produce excess amounts of histamine, can trigger a painful immune system response.

Another study found that women with fibromyalgia have strikingly different types and amounts of bacteria than those without fibromyalgia. Faecalibacterium prausnitzii, a “good” bacterium that is normally abundant in the human gut, was found to be depleted in fibromyalgia patients. Other bacteria associated with IBS, CFS and interstitial cystitis were found to be abundant in fibromyalgia patients, but not in the healthy control group.  

New Covid Variant Leading Surge in Respiratory Illness

By Julie Appleby, KFF Health News

It’s winter, that cozy season that brings crackling fireplaces, indoor gatherings — and a wave of respiratory illness. Nearly four years since the pandemic emerged, people are growing weary of dealing with it, but the virus is not done with us.

Nationally, a sharp uptick in emergency room visits and hospitalizations for covid-19, influenza, and respiratory syncytial virus, or RSV, began in mid-December and appears to be gaining momentum.

Here are a few things to know this time around:

What’s Circulating Now?

The covid virus is continually changing, and a recent version is rapidly climbing the charts. Even though it appeared only in September, the variant known as JN.1, a descendant of omicron, is rapidly spreading, representing between 39% to half of the cases, according to pre-holiday stats from the Centers for Disease Control and Prevention.

Lab data indicates that the updated vaccines, as well as existing covid rapid tests and medical treatments, are effective with this latest iteration. More good news is that it “does not appear to pose additional risks to public health beyond that of other recent variants,” according to the CDC.

Even so, new covid hospitalizations — 34,798 for the week that ended Dec. 30 — are trending upward, although rates are still substantially lower than last December’s tally. It’s early in the season, though. Levels of virus in wastewater — one indicator of how infections are spreading — are “very high,” exceeding the levels seen this time last year.

And don’t forget, other nasty bugs are going around. More than 20,000 people were hospitalized for influenza the week ending Dec. 30, and the CDC reports that RSV remains elevated in many areas.

“The numbers so far are definitely going in the not-so-good direction,” said Ziyad Al-Aly, the chief of the research and development service at the Veterans Affairs St. Louis Healthcare System and a clinical epidemiologist at Washington University in St. Louis. “We’re likely to see a big uptick in January now that everyone is back home from the holidays.”

Milder Cases and Fewer Deaths

Certainly, compared with the first covid winter, things are better now. Far fewer people are dying or becoming seriously ill, with vaccines and prior infections providing some immunity and reducing severity of illness.

Even compared with last winter, when omicron was surging, the situation is better. New hospitalizations, for example, are about one-third of what they were around the 2022 holidays. Weekly deaths dropped slightly the last week of December to 839 and are also substantially below levels from a year ago.

“The ratio of mild disease to serious clearly has changed,” said William Schaffner, a professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine in Nashville, Tennessee.

Even so, the definition of “mild” is broad, basically referring to anything short of being sick enough to be hospitalized.

While some patients may have no more than the sniffles, others experiencing “mild” covid can be “miserable for three to five days,” Schaffner said.

How Will This Affect My Day-to-Day Life?

“Am I going to be really sick? Do I have to mask up again?” It is important to know the basics.

For starters, symptoms of the covid variants currently circulating will likely be familiar — such as a runny nose, sore throat, cough, fatigue, fever, and muscle aches.

So if you feel ill, stay home, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. “It can make a big difference.”

Dust off those at-home covid test kits, check the extended expiration dates on the FDA website, and throw away the ones that have aged out. Tests can be bought at most pharmacies and, if you haven’t ordered yours yet, free test kits are still available through a federal program at covid.gov.

Test more than once, especially if your symptoms are mild. The at-home rapid tests may not detect covid infection in the first couple of days, according to the FDA, which recommends using “multiple tests over a certain time period, such as two to three days.”

With all three viruses, those most at risk include the very young, older adults, pregnant people, and those with compromised immune systems or underlying diseases, including cancer or heart problems. But those without high-risk factors can also be adversely affected.

While mask-wearing has dropped in most places, you may start to see more people wearing them in public spaces, including stores, public transit or entertainment venues.

Although a federal mask mandate is unlikely, health officials and hospitals in at least four states — California, Illinois, Massachusetts, and New York — have again told staff and patients to don masks. Such requirements were loosened last year when the public health emergency officially ended.

Such policies are advanced through county-level directives. The CDC data indicates that, nationally, about 46.7% of counties are seeing moderate to high hospital admission rates of covid.

“We are not going to see widespread mask mandates as our population will not find that acceptable,” Schaffner noted. “That said, on an individual basis, mask-wearing is a very intelligent and reasonable thing to do as an additional layer of protection.”

The N95, KN95, and KF94 masks are the most protective. Cloth and paper are not as effective.

And, finally, if you haven’t yet been vaccinated with an updated covid vaccine or gotten a flu shot, it’s not too late. There are also new vaccines and monoclonal antibodies to protect against RSV recommended for certain populations, which include older adults, pregnant people, and young children.

Generally, flu peaks in midwinter and runs into spring. Covid, while not technically seasonal, has higher rates in winter as people crowd together indoors.

“If you haven’t received vaccines,” Schaffner said, “we urge you to get them and don’t linger.”

Repeat Infections

People who have dodged covid entirely are in the minority.

At the same time, repeat infections are common. Fifteen percent of respondents to a recent Yahoo News/YouGov poll said they’d had covid two or three times. A Canadian survey released in December found 1 in 5 residents said they had gotten covid more than once as of last June.

Aside from the drag of being sick and missing work or school for days, debate continues over whether repeat infections pose smaller or larger risks of serious health effects. There are no definitive answers, although experts continue to study the issue.

Two research efforts suggest repeat infections may increase a person’s chances of developing serious illness or even long covid — which is defined various ways but generally means having one or more effects lingering for a month or more following infection. The precise percentage of cases — and underlying factors — of long covid and why people get it are among the many unanswered questions about the condition. However, there is a growing consensus among researchers that vaccination is protective.

Still, the VA’s Al-Aly said a study he co-authored that was published in November 2022 found that getting covid more than once raises an “additional risk of problems in the acute phase, be it hospitalization or even dying,” and makes a person two times as likely to experience long covid symptoms.

The Canadian survey also found a higher risk of long covid among those who self-reported two or more infections. Both studies have their limitations: Most of the 6 million in the VA database were male and older, and the data studied came from the first two years of the pandemic, so some of it reflected illnesses from before vaccines became available. The Canadian survey, although more recent, relied on self-reporting of infections and conditions, which may not be accurate.

Still, Al-Aly and other experts say taking preventive steps, such as getting vaccinated and wearing a mask in higher-risk situations, can hedge your bets.

“Even if in a prior infection you dodged the bullet of long covid,” Al-Aly said, “it doesn’t’ mean you will dodge the bullet every single time.”

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

Stopping Long-Term Use of Benzodiazepines Increases Risk of Death

By Pat Anson, PNN Editor

Abruptly stopping long-term treatment with benzodiazepines nearly doubles the risk of a patient dying within a year, according to a large new study.

Benzodiazepines such as Valium and Xanax have long been used to treat anxiety, insomnia and seizures, but their coprescribing with opioids is controversial because both drugs cause respiratory depression, increasing the risk of an overdose.

In 2016, the CDC warned doctors to avoid coprescribing opioids and benzodiazepines “whenever possible.” That same year, the FDA warned that taking the drugs concurrently has serious risks, including “profound sedation, respiratory depression, coma and death.”

Those warnings led many prescribers to abruptly take their patients off benzodiazepines, which many used safely for years. Some patients took opioids and benzodiazepines with a muscle relaxant, a combination known as the “Holy Trinity.”  

Researchers at the University of Michigan analyzed the insurance claims of over 350,000 adults prescribed benzodiazepines long-term from 2013 to 2019, expecting to find the FDA and CDC warnings validated. To their surprise, the risk of death from suicide, accidents and other causes rose for patients in the 12 months after benzodiazepines were discontinued.

“These results were unexpected,” researchers reported in JAMA Network Open. “Given the increased OD (overdose) risk and mortality associated with benzodiazepine prescribing, particularly when coprescribed with opioids, we anticipated that discontinuing benzodiazepine prescriptions would be associated with a lower mortality risk.

“However, for every outcome examined in this analysis, discontinuation was associated with some degree of increased risk — at odds with the assumption underlying ongoing policy efforts that reducing benzodiazepine prescribing to long-term users will decrease harms.”

Researchers found that patients on opioids who stopped taking benzodiazepines had a 6.3% risk of dying over the next year, compared to 3.9% of those who continued taking both drugs. Patients who were discontinued also had a slightly higher risk of a nonfatal overdose, suicidal thoughts, and emergency department visits.

Risk of Death for Opioid Patients Taken Off Benzodiazepines

JAMA NETWORK OPEN

"I think it is important to revisit the assumption that tapering stable long-term users should be the default and instead, perhaps, focus on those with clearly elevated risk of harms," lead author Donovan Maust, MD, a geriatric psychiatrist at UM Health, told MedPage Today.

Maust and his colleagues say patients discontinued from benzodiazepines could be suffering the effects of withdrawal or may be turning to other substances such as cannabis or alcohol. Given the risks involved, they urge prescribers to be “judicious” when prescribing benzodiazepines for the first time and to carefully limit their long-term use.

Older Americans Feel Trapped in Medicare Advantage Plans

By Sarah Jane Tribble, KFF Health News  

In 2016, Richard Timmins went to a free informational seminar to learn more about Medicare coverage.

“I listened to the insurance agent and, basically, he really promoted Medicare Advantage,” Timmins said. The agent described less expensive and broader coverage offered by the plans, which are funded largely by the government but administered by private insurance companies.

For Timmins, who is now 76, it made economic sense then to sign up. And his decision was great, for a while.

Then, three years ago, he noticed a lesion on his right earlobe.

“I have a family history of melanoma. And so, I was kind of tuned in to that and thinking about that,” Timmins said of the growth, which doctors later diagnosed as malignant melanoma. “It started to grow and started to become rather painful.”

Timmins, though, discovered that his enrollment in a Premera Blue Cross Medicare Advantage plan would mean a limited network of doctors and the potential need for preapproval, or prior authorization, from the insurer before getting care. The experience, he said, made getting care more difficult, and now he wants to switch back to traditional, government-administered Medicare.

But he can’t. And he’s not alone.

RICHARD TIMMINS

“I have very little control over my actual medical care,” he said, adding that he now advises friends not to sign up for the private plans. “I think that people are not understanding what Medicare Advantage is all about.”

Low Premiums and Extra Benefits

Enrollment in Medicare Advantage plans has grown substantially in the past few decades, enticing more than half of all eligible people, primarily those 65 or older, with low premium costs and perks like dental and vision insurance. And as the private plans’ share of the Medicare patient pie has ballooned to 30.8 million people, so too have concerns about the insurers’ aggressive sales tactics and misleading coverage claims.

Enrollees, like Timmins, who sign on when they are healthy can find themselves trapped as they grow older and sicker.

“It’s one of those things that people might like them on the front end because of their low to zero premiums and if they are getting a couple of these extra benefits — the vision, dental, that kind of thing,” said Christine Huberty, a lead benefit specialist supervising attorney for the Greater Wisconsin Agency on Aging Resources.

“But it’s when they actually need to use it for these bigger issues,” Huberty said, “that’s when people realize, ‘Oh no, this isn’t going to help me at all.’”

Medicare pays private insurers a fixed amount per Medicare Advantage enrollee and in many cases also pays out bonuses, which the insurers can use to provide supplemental benefits. Huberty said those extra benefits work as an incentive to “get people to join the plan” but that the plans then “restrict the access to so many services and coverage for the bigger stuff.”

Switching Plans

David Meyers, assistant professor of health services, policy, and practice at the Brown University School of Public Health, analyzed a decade of Medicare Advantage enrollment and found that about 50% of beneficiaries — rural and urban — left their contract by the end of five years. Most of those enrollees switched to another Medicare Advantage plan rather than traditional Medicare.

In the study, Meyers and his co-authors muse that switching plans could be a positive sign of a free marketplace but that it could also signal “unmeasured discontent” with Medicare Advantage.

“The problem is that once you get into Medicare Advantage, if you have a couple of chronic conditions and you want to leave Medicare Advantage, even if Medicare Advantage isn’t meeting your needs, you might not have any ability to switch back to traditional Medicare,” Meyers said.

Traditional Medicare can be too expensive for beneficiaries switching back from Medicare Advantage, he said. In traditional Medicare, enrollees pay a monthly premium and, after reaching a deductible, in most cases are expected to pay 20% of the cost of each nonhospital service or item they use. And there is no limit on how much an enrollee may have to pay as part of that 20% coinsurance if they end up using a lot of care, Meyers said.

To limit what they spend out-of-pocket, traditional Medicare enrollees typically sign up for supplemental insurance, such as employer coverage or a private Medigap policy. If they are low-income, Medicaid may provide that supplemental coverage.

But, Meyers said, there’s a catch: While beneficiaries who enrolled first in traditional Medicare are guaranteed to qualify for a Medigap policy without pricing based on their medical history, Medigap insurers can deny coverage to beneficiaries transferring from Medicare Advantage plans or base their prices on medical underwriting.

Only four states — Connecticut, Maine, Massachusetts, and New York — prohibit insurers from denying a Medigap policy if the enrollee has preexisting conditions such as diabetes or heart disease.

Paul Ginsburg is a former commissioner on the Medicare Payment Advisory Commission, also known as MedPAC. It’s a legislative branch agency that advises Congress on the Medicare program. He said the inability of enrollees to easily switch between Medicare Advantage and traditional Medicare during open enrollment periods is “a real concern in our system; it shouldn’t be that way.”

The federal government offers specific enrollment periods every year for switching plans. During Medicare’s open enrollment period, from Oct. 15 to Dec. 7, enrollees can switch out of their private plans to traditional, government-administered Medicare.

Medicare Advantage enrollees can also switch plans or transfer to traditional Medicare during another open enrollment period, from Jan. 1 to March 31.

“There are a lot of people that say, ‘Hey, I’d love to come back, but I can’t get Medigap anymore, or I’ll have to just pay a lot more,’” said Ginsburg, who is now a professor of health policy at the University of Southern California.

Timmins is one of those people. The retired veterinarian lives in a rural community on Whidbey Island just north of Seattle. It’s a rugged, idyllic landscape and a popular place for second homes, hiking, and the arts. But it’s also a bit remote.

While it’s typically harder to find doctors in rural areas, Timmins said he believes his Premera Blue Cross plan made it more challenging to get care for a variety of reasons, including the difficulty of finding and getting in to see specialists.

Nearly half of Medicare Advantage plan directories contained inaccurate information on what providers were available, according to the most recent federal review. Beginning in 2024, new or expanding Medicare Advantage plans must demonstrate compliance with federal network expectations or their applications could be denied.

Amanda Lansford, a Premera Blue Cross spokesperson, declined to comment on Timmins’ case. She said the plan meets federal network adequacy requirements as well as travel time and distance standards “to ensure members are not experiencing undue burdens when seeking care.”

Traditional Medicare allows beneficiaries to go to nearly any doctor or hospital in the U.S., and in most cases enrollees do not need approval to get services.

Timmins, who recently finished immunotherapy, said he doesn’t think he would be approved for a Medigap policy, “because of my health issue.” And if he were to get into one, Timmins said, it would likely be too expensive. For now, Timmins said, he is staying with his Medicare Advantage plan.

“I’m getting older. More stuff is going to happen.”

There is also a chance, Timmins said, that his cancer could resurface: “I’m very aware of my mortality.”

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

New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.   

The Emergency Room Quandary

By Carol Levy, PNN Columnist

I went to the ER only once because my pain was so out of control. The nurses and the doctor were nice, but mostly I was ignored. After waiting what seemed like hours, a nurse came to my bedside with a needle.

"Hold out your arm," she said and injected me with... something. She didn't say what it was.

The pain was so overwhelming, I didn't ask. Whatever it was, it did nothing, not even make me drowsy.

They kept me there for a few more hours, offering nothing after the injection but a cursory, "Sorry it didn't help you" and "Maybe rest will help."

After another hour or so, I left. They were of no help. They could be of no help.

I used to work as an emergency room ward clerk, the first person people saw when they came in. I would run back to get a doctor or nurse if a patient had one of three complaints: chest pain, symptoms of a kidney stone, or a migraine. Those patients were immediately taken to an exam room.

All the other patients I signed in, then directed them to the waiting room. “Please have a seat and wait for your name to be called,” I’d tell them.

Often, they would sit for hours watching as others who came in were immediately taken to the exam room. I had to repeatedly explain that other patients' complaints were more serious and they had to be seen first.

Some of those waiting patients became angry. They had no clue how many patients were already in the exam rooms, or if the doctors and nurses were dealing with critically injured patients from auto accidents or others with serious health issues.

The ones who came in with complaints of “I have a cold” or “I hurt my finger 3 weeks ago” went to the bottom of the list. So too did those whose main complaint — such as chronic pain — was not of immediate concern. It may have seemed like an emergency to them, but to the ER staff it often isn't. An emergency room can never operate on a first come, first serve basis.

Often, as chronic pain sufferers, we have trouble finding doctors or pain management specialists who are willing to take us as patients. Without a doctor we are vulnerable. When the pain gets too bad or feels uncontrollable, our only alternative may be the ER.

The problem with that is the emergency room is not going to help us much, if at all. They don't know our history. They don't know us. When a patient says they don’t have a doctor and insists on getting opioid pain medication, they immediately become suspect. They might be an addict trying to cadge an opioid.

We are so mired in the “opioid crisis” that it blinds us to the other issues that are harming us. We need to look at all the issues that make us vulnerable. Being able to find a doctor should be high on the list of what we need to fight for.

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.

Fascia: An Overlooked Cause of Chronic Pain

By Dr. Adam Taylor, Lancaster University

We are constantly reminded about how exercise benefits our bone and muscle health or reduces fat. However, there is also a growing interest in one element of our anatomy that is often overlooked: our fascia.

Fascia is a thin casing of connective tissue, mainly made of collagen – a rope-like structure that provides strength and protection to many areas of the body. It surrounds and holds every organ, blood vessel, bone, nerve fibre and muscle in place. And scientists increasingly recognise its importance in muscle and bone health.

It is hard to see fascia in the body, but you can get a sense of what it looks like if you look at a steak. It is the thin white streaks on the surface or between layers of the meat.

Fascia provides general and special functions in the body, and is arranged in several ways. The closest to the surface is the superficial fascia, which is underneath the skin between layers of fat. Then we have the deep fascia that covers the muscles, bones and blood vessels.

The link between fascia, muscle and bone health and function is reinforced by recent studies that show the important role fascia has in helping the muscles work, by assisting the contraction of the muscle cells to generate force and affecting muscle stiffness.

Each muscle is wrapped in fascia. These layers are important as they enable muscles that sit next to, or on top of, each other to move freely without affecting each other’s functions.

Fascia also assists in the transition of force through the musculoskeletal system. An example of this is our ankle, where the achilles tendon transfers force into the plantar fascia. This sees forces moving vertically down through the achilles and then transferred horizontally into the bottom of the foot - the plantar fascia – when moving.

Similar force transition is seen from muscles in the chest running down through to groups of muscles in the forearm. There are similar fascia connective chains through other areas of the body.

When Fascia Gets Damaged

When fascia doesn’t function properly, such as after injury, the layers become less able to facilitate movement over each other or help transfer force. Injury to fascia takes a long time to repair, probably because it possesses similar cells to tendons (fibroblasts), and has a limited blood supply.

Recently, fascia, particularly the layers close to the surface, have been shown to have the second-highest number of nerves after the skin. The fascial linings of muscles have also been linked to pain from surgery to musculoskeletal injuries from sports, exercise and ageing. Up to 30% of people with musculoskeletal pain may have fascial involvement or fascia may be the cause.

A type of massage called fascial manipulation, developed by Italian physiotherapist Luigi Stecco in the 1980s, has been shown to improve the pain from patellar tendinopathy (pain in the tendon below the kneecap), both in the short and long term.

Fascial manipulation has also shown positive results in treating chronic shoulder pain.

One of the growing trends for helping with musculoskeletal injuries is Kinesio tape, which is often used in professional sports, although evidence for its effectiveness is mixed. It is also being used to complement the function of the fascia, and is used to treat chronic lower back pain where fascial involvement is a factor.

Fascia in Disease

Aside from getting damaged, fascia can also provide paths that infections can travel along, within muscles.

The spaces between fascial layers are usually closed (think of cling film being folded over), but when an infection occurs, germs can spread between these layers. This is a particular problem in the neck, where there are several layers of fascia for infections to travel along. In severe cases, surgery is often needed to remove the dead tissue and save the healthy remaining tissue.

One of the primary examples of fascia functioning in health, and the challenges its dysfunction can bring, is seen in the common complaint plantar fasciitis, which causes pain on around the heel and arch of the foot.

This incredibly common ailment affects 5-7% of people, rising to 22% in athletes. It is recognised as an overuse injury, causing the thickening of the fascial bands on the soles of the feet that help give the arch support.

Fascia can also be implicated in more serious health conditions, such as necrotising fasciitis. This is a rare but serious bacterial condition that can spread through the body quickly and cause death.

The condition is almost always caused by bacteria, specifically group A Streptococcus or Staphylococcus aureus. The initial infection comes from a cut or scratch, and then the bacteria travel along the fascia to other areas away from the initial site of access and multiply in the ideal environment afforded by the warm recesses of the body.

One reason fascia has been overlooked in health and disease is because it was difficult to see using current imaging technology. More recently, though, MRI and ultrasound imaging have been shown to be beneficial in visualising fascia, particularly in musculoskeletal conditions such as plantar fasciitis, and pathological changes in the fascia of the shoulder and neck.

With the growing interest in fascia and the growing understanding of its contribution to musculoskeletal health, it’s sensible to suggest that we look after it in the same way we do with the rest of the musculoskeletal system - by using it. Simple techniques like foam rollers and stretching are beneficial in increasing mobility, but there is still much to learn about our fascia and the role it plays in our day-to-day health.

Adam Taylor, PhD, is a Professor and Director of the Clinical Anatomy Learning Centre at Lancaster University. His research interests lie within the field of osteoarthritis and the degeneration of cartilage and bone.

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

What Money Can’t Buy

By Mia Maysack, PNN Columnist

Just about everyone I've encountered has commented on their lack of cheer over the holiday season. I can relate to that in my own way, but also think we put too much pressure on ourselves to be appropriately cheerful when the calendar tells us to be.

I have been disheartened by the fact society presents the holidays as a joyous time, when they really seem to be more of an excuse to spend more than we should and consume more than we need.

This often results in people being rude in stores or driving recklessly, as if their lives are more important than anyone else's. We fixate on what we want or lack -- as opposed to what others may need. The holiday spirit should be less about us and more about what we can do for others.

Some of us are without our loved ones-- not just during the holidays, but literally every day. In the very house or apartment next to yours, there could be someone silently suffering. On our own streets, people are homeless or starving as we rush by them, too busy to care. On the other side of the world, there are innocent people effectively being wiped out via genocide.

I think it's absolutely okay that we are not all that jolly. In fact, if we were, there would be something extraordinarily wrong with that. This isn't to belittle anyone feeling joyful, it's solely a matter of keeping things in perspective.

Please take time in the new year to enjoy this opportunity to love yourself and appreciate those around you. If you are working, understand that your job is the dream of the unemployed. Reflect on what you've made it through and accomplished -- even if all you managed to do was live another year and survive.

Do something small to lift yourself up -- whether its fresh air, listening to music, making a tasty dish, or volunteering or donating in a meaningful way for another person.

There will come a day when the only things you long for are those that money can’t buy. There will be times when you'd give anything to revisit the past that came and went so quickly.

The only item on our holiday wish lists should be more time – time to optimally utilize the gifts we already have and to make the most of life while we still can.

Sending prayers to all of you for a safe, healthy and gentle 2024.

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.

DEA Finalizes More Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration will further reduce the supply of codeine, morphine, oxycodone and other prescription opioids in 2024, ignoring complaints from thousands of patients that opioid pain medication is already difficult to obtain and many pharmacies are out of stock.

In a notice pre-published Friday in the Federal Register, the DEA said it would stick with plans to cut aggregate production quotas (APQs) for prescription opioids for the eighth consecutive year, reducing the supply to levels not seen in nearly a decade.

“After considering all of the relevant factors, DEA has determined that the APQs of prescription opioids should be reduced from calendar year 2023 APQ levels and they are sufficient to meet the forecasted domestic and foreign medical needs,” the DEA said.

Under the Controlled Substances Act, the DEA has broad legal authority to set APQs annually for hundreds of Schedule I and II chemicals and medications – in effect telling drug manufacturers how much they can make each year.

Acting on the advice of the Food and Drug Administration, which estimates there will be a be a 7.9% decline in medical need for opioids next year, the DEA in early November published its proposed APQs for 2024 in the Federal Register and invited public comment.      

Nearly 4,700 comments came in, mostly from pain patients worried that further cuts in the opioid supply would worsen shortages and interfere with their treatment.  

“I am pretty much bed bound. A couple of weeks ago I tried taking my life,” one patient wrote. “No one should have to suffer like this. These are medications that work. And why is it that the prescriptions have gone down but overdoses have gone up?”

“Please do not cut the Rx opioid production amount anymore. There is a severe shortage and many people who have prescriptions cannot get them filled at a pharmacy,” another poster said.

The American Society of Health-System Pharmacists (ASHP) has been warning about shortages of hydrocodone and oxycodone for months, but those shortages have yet to be recognized by the FDA or DEA.  If any shortages exist, DEA said they were out of its control and blamed the “temporary lack of inventory” on drug manufacturers.

“DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution and supply during the year. However, drug shortages may occur subsequently due to factors outside of DEA control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.

“Manufacturers’ business practices may… potentially contribute to a temporary lack of inventory of controlled substances at the point of dispensation. In recent years, this has included labor shortages and a lack of production capacity.”

The DEA’s final order reduces the supply of codeine year-to-year by 8.3 percent, followed by morphine (4.3%), hydromorphone (2.1%), hydrocodone (0.35%) and oxycodone (0.34%). Since 2015, APQs for most opioids have been cut by over two-thirds.

DEA admits that its “reliable data” on drug production may not be all that reliable. The agency said there was a “lack of real-time data and gaps in its understanding of production lead times,” which weaken its ability to respond to drug shortages. As a result, it was seeking more up to date information from manufacturers on their drug sales and inventory.

Late Notice to Drug Makers

The production quotas for 2024 won’t be officially published in the Federal Register until Wednesday, January 3rd – which is about a month overdue and gives little time for drug manufacturers to prepare for the coming year. That appears to be a violation of the Controlled Substances Act (CSA), which stipulates that APQs be established by the U.S. Attorney General – who the DEA reports to -- “on or before December 1 of each year.”  

(Update: In a 1/4/24 email to PNN, the DEA confirmed that drug makers were only now being notified of their quota allotments for 2024. “DEA registrants cannot receive notification of their individual quotas until the final APQ notice is signed and published in the FR (Federal Register) per the CSA,” the email said. There was no explanation for the late publication of the final APQ.)   

Another concern for drug makers besides the late notice is a DEA plan to set production quotas for each company on a quarterly basis, instead of annually. A Pfizer representative expressed strong reservations about that, saying it could hamstring drug production and worsen shortages of injectable drugs used in anesthesia, which have been in short supply for years.  

“DEA’s proposal to allocate quota on a quarterly basis will make manufacturing lead times, planning schedules, and resource allocation extremely difficult if not untenable,” Jennifer Walton, Senior Vice President at Pfizer, wrote in a letter to the agency.

“As an example, from the time API (active pharmaceutical ingredient) is received at a manufacturing plant to the time finished product is ready for shipment, the lead time can be as long as six months, stretching over multiple quarters. Given those time frames, DEA’s proposed quarterly quota grants will likely result in interruptions in supply of sterile injectable products used in the inpatient setting.”  

Evidence Should Be Updated for Covid-19 Treatment

By Dr. Lynora Saxinger, Undark Magazine

Strong science, particularly vaccine development, helped us steer our way through the Covid-19 pandemic. Now, as the pandemic recedes, it’s time to hold drug companies accountable for the treatments they’ve developed.

The evidence for these medications has not kept pace with major changes in the nature of the Covid-19 pandemic, and updated studies should be required to maintain approval for these very profitable drugs.

The Covid-19 drug development battlefield is littered with 479 failed or inactive drugs, while 358 are still in clinical or preclinical trials, according to a tracker maintained by the Biotechnology Innovation Organization, a trade group.

The only oral Covid-19 therapy approved by the U.S. Food and Drug Administration that is recommended for first line outpatient use is Pfizer’s Paxlovid (nirmatrelvir-ritonavir), a two-drug combination that stops the SARS-CoV-2 virus from replicating in the body.

Hailed as a game changer, Paxlovid is a very good antiviral drug that has saved many lives, and its incredibly rapid development was a feat of science.

The major study leading to its approval, called the EPIC-HR trial, showed that it reduced the risk of hospitalization and death by an impressive 89 percent in high-risk, unvaccinated people.

But there is a lack of high-quality research on how Paxlovid affects outcomes beyond severe Covid — such as duration of illness, how the drug affects transmission, and whether it prevents long Covid. Nevertheless, some physicians are promoting the drug for these uses based on weak, inconsistent data.

pfizer image

The stakes are high: If we fail to set a requirement for well-designed studies of Paxlovid’s impact on all concerns besides hospitalization and death, we will be setting up a slow-moving, disastrous recreation of mistakes made with drugs for other diseases such as influenza.

Early in the Covid-19 pandemic, the explosive, unorganized growth of clinical trials for treatments was intended to save lives from this fearsome new disease. But many trials were small and of low quality, with a few exceptional trials providing much of our good data. In that initial desperate push for Covid-19 treatments, experimental, everything-but-the-kitchen-sink approaches became widely used.

Ivermectin Controversy

The case of ivermectin is instructive: This antiparasitic drug was used in tremendous volumes based on poor quality and sometimes outright fraudulent data, despite advice against its use from the FDA and in formal treatment guidelines. Social media amplification of the increasingly dubious evidence base led to a near-delusional belief in its benefit — and impressive profits for some opportunistic doctors.

A few well-coordinated and well-designed trials up front would have shortened the controversy, saved costs, and avoided duplicated effort of smaller low-quality trials. Most importantly, showing it to be ineffective earlier may have prevented the ensuing social media crusade, perhaps allowing some high-risk people to accept evidence-supported treatments like Paxlovid and the intravenous antiviral remdesivir rather than requesting, or even suing hospitals, to administer ivermectin.

Covid-19’s infection outcomes changed unusually rapidly across waves of the pandemic, which meant that studies could be outdated in months if they did not reflect the current viral strains and population immune responses. Data collection in the EPIC-HR study, which still guides treatment with Paxlovid, took place in 2021 when hospitalization rates were high, many were unvaccinated (including all trial participants), the viral strains were different than today, and the main outcome of interest in many communities was “flattening the curve,” or preventing hospitalization.

Now, almost everyone has been vaccinated, infected, or both. In a recent study, 96.4 percent of U.S. blood donors had Covid-19 antibodies by September 2022. The overall risk of hospitalization and death has also decreased significantly.

A Different Disease

Essentially, we are now dealing with a different disease. We are more focused on outcomes such as time lost from work, transmission risk, and long Covid risk. Yet there is almost no direct evidence about Paxlovid’s effect on these outcomes.

Paxlovid was approved for the treatment of mild to moderate Covid-19 in adults at high risk of developing severe disease. However, physicians and pharmacists have told me, it is increasingly being prescribed off-label for lower risk patients. This contention is supported by a recent U.S.-based preprint showing that 42 percent of more than 111,000 Paxlovid recipients had no major medical comorbidities, with treatment eligibility defined by having at least one risk factor for severe Covid-19.

Some physicians are extrapolating from hamster studies and lab data to suggest it reduces Covid-19 transmission. And they’re prescribing it to reduce long Covid risk based on very weak studies that analyzed administrative databases for Covid-19 complications rather than tracking long Covid symptoms in treated and untreated patients.

This matters because Paxlovid treatment for people who are not high risk has not shown significant benefit. One still unpublished randomized trial of lower-risk patients was terminated because low rates of hospitalization overall (in treated and untreated people) made it impossible to see a benefit.

Even in higher-risk groups, a recent meta-analysis of observational studies has shown very little absolute reduction of mortality, and no benefit in such patients under age 60. At the same time, people taking Paxlovid face possible side effects, drug interactions, and volatile drug pricing. They do not know if Paxlovid is worth all of that. They don’t know if the drug will reduce transmission to others, if they are less likely to get severely ill, if they will need time off work, or if it will spare them from long Covid.

Tamiflu Questions

Infectious diseases specialists like myself are experiencing an alarming sense of déjà vu. Tamiflu (oseltamivir), a treatment for influenza, was licensed in 1999 with data showing a modest benefit in reducing illness by one day. The reviewers noted that a “more definitive demonstration of clinical or public health relevance” would require additional data.

But 24 years later, we are not farther ahead — important questions about Tamiflu remain unanswered, with longstanding debates about the benefit of the drug and a false advertising lawsuit that went on for nearly 10 years before being dropped in July. The guidelines for the use of Tamiflu in influenza vary tremendously because of varied interpretation of a poor evidence base, and newer studies call its use as an influenza treatment into question. Even so, in its first 15 years on the market, Tamiflu made $18 billion in sales.

It is hard to stop a prescribing practice once it has become the norm, despite inadequate data. This is a recognized driver of cost increases in health care.

Pharmaceutical companies play a pivotal role in the research and development of effective therapies, and their lifesaving contributions during the Covid-19 pandemic have been commendable. However, the major investments these companies make in R&D should not give them free rein to market high-cost, high-volume drugs of public health importance without continued scrutiny of their effectiveness if the initial registration studies no longer stand because of changes in the disease.

Some bold, novel options could help address this gap in evidence. In exceptional circumstances (such as pandemics), pharmaceutical companies could be required to conduct studies to reassess a drug’s effectiveness after it has entered the market if conditions have meaningfully changed since the initial trials.

Another option could require companies to put a small portion of drug profits towards funding well-designed, independent trials so that crucial, commercially successful drugs would be part of ongoing studies. The FDA and other agencies should judiciously require and support such studies that could help guide treatment decisions, while balancing the need to support appropriate research and new drug development.

The medical community has responsibility, too: Professional societies that draft treatment guidelines must take a more consistently assertive stance in advising against uses for which there is insufficient evidence, rather than leaving it open to prescriber judgment. Both prescribers and potential patients need to accept and use evidence to help sustain health care systems, and lobby for changes needed to define the best treatments for people with Covid-19.

We are at a unique juncture in the fight against Covid-19, as fear gives way to complacency — and the path forward is scientific rigor. Failing to mandate high-quality evidence for treatment choices may lead us back down the path of inadequately researched treatments, opinion-driven guidelines, and wasted resources.

Pfizer has raked in about $20 billion dollars in revenue from Paxlovid alone over the last two years. This sum is nearly half of the National Institutes of Health’s entire budget for 2022. It is not surprising that the company has not voluntarily started additional trials after approval based on the stellar results in that first, now-irrelevant trial.

In the wake of the pandemic, we have an opportunity to improve both what we are doing, and how we may address research challenges in a future crisis. Paxlovid’s price is set to increase — from $530 to $1,390 before insurance — next year, but there is no corresponding increase in our knowledge of its value. The cost of this information gap will be very high, for both individuals and health care systems.

Lynora Saxinger, MD, is a journalist, infectious disease physician, and professor at the University of Alberta who headed a Covid evidence synthesis group during the pandemic. She is currently a Fellow in Journalism and Health Impact at the Dalla Lana School for Public Health.

This article was originally published by Undark, a non-profit, editorially independent online magazine covering the complicated and often fractious intersection of science and society. You can read the original article here.

Lax FDA Oversight of Medical Devices Exposed in Lawsuits

By Fred Schulte and Holly K. Hacker, KFF Health News  

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

CARLA WIGGINS AND CARLTON GAUTNEY

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.

• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.

• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.

• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed for this article.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall.

More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

MiniMed 670G insulin pump (MEDTRONIC IMAGE)

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data.

Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.”

The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show.

In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused. According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit. In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021. One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.”

For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘New and Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

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

Health Misinformation Rampant on Social Media

By Dr. Monica Wang, Boston University

The global anti-vaccine movement and vaccine hesitancy that accelerated during the COVID-19 pandemic show no signs of abating.

According to a survey of U.S. adults, Americans in October 2023 were less likely to view approved vaccines as safe than they were in April 2021. As vaccine confidence falls, health misinformation continues to spread like wildfire on social media and in real life.

I am a public health expert in health misinformation, science communication and health behavior change.

In my view, we cannot underestimate the dangers of health misinformation and the need to understand why it spreads and what we can do about it. Health misinformation is defined as any health-related claim that is false based on current scientific consensus.

False Claims About Vaccines

Vaccines are the No. 1 topic of misleading health claims. Some common myths about vaccines include:

• Their supposed link with human diagnoses of autism. Multiple studies have discredited this claim, and it has been firmly refuted by the World Health Organization, the National Academies of Sciences, Engineering and Medicine, the American Academy of Pediatrics and the Centers for Disease Control and Prevention.

• Concerns with the COVID-19 vaccine leading to infertility. This connection has been debunked through a systematic review and meta-analysis, one of the most robust forms of synthesizing scientific evidence.

• Safety concerns about vaccine ingredients, such as thimerosal, aluminum and formaldehyde. Extensive studies have shown these ingredients are safe when used in the minimal amounts contained in vaccines.

• Vaccines as medically unnecessary to protect from disease. The development and dissemination of vaccines for life-threatening diseases such as smallpox, polio, measles, mumps, rubella and the flu has saved millions of lives. It also played a critical role in historic increases in average life expectancy – from 47 years in 1900 in the U.S. to 76 years in 2023.

High Cost of Misinformation

Beliefs in such myths have come at the highest cost.

An estimated 319,000 COVID-19 deaths that occurred between January 2021 and April 2022 in the U.S. could have been prevented if those individuals had been vaccinated, according to a data dashboard from the Brown University School of Public Health. Misinformation and disinformation about COVID-19 vaccines alone have cost the U.S. economy an estimated US$50 million to $300 million per day in direct costs from hospitalizations, long-term illness, lives lost and economic losses from missed work.

Though vaccine myths and misunderstandings tend to dominate conversations about health, there is an abundance of misinformation on social media surrounding diets and eating disorders, smoking or substance use, chronic diseases and medical treatments.

My team’s research and that of others show that social media platforms have become go-to sources for health information, especially among adolescents and young adults. However, many people are not equipped to maneuver the maze of health misinformation.

For example, an analysis of Instagram and TikTok posts from 2022 to 2023 by The Washington Post and the nonprofit news site The Examination found that the food, beverage and dietary supplement industries paid dozens of registered dietitian influencers to post content promoting diet soda, sugar and supplements, reaching millions of viewers. The dietitians’ relationships with the food industry were not always made clear to viewers.

Studies show that health misinformation spread on social media results in fewer people getting vaccinated and can also increase the risk of other health dangers such as disordered eating and unsafe sex practices and sexually transmitted infections. Health misinformation has even bled over into animal health, with a 2023 study finding that 53% of dog owners surveyed in a nationally representative sample report being skeptical of pet vaccines.

Declining Trust

One major reason behind the spread of health misinformation is declining trust in science and government. Rising political polarization, coupled with historical medical mistrust among communities that have experienced and continue to experience unequal health care treatment, exacerbates preexisting divides.

The lack of trust is both fueled and reinforced by the way misinformation can spread today. Social media platforms allow people to form information silos with ease; you can curate your networks and your feed by unfollowing or muting contradictory views from your own and liking and sharing content that aligns with your existing beliefs and value systems.

By tailoring content based on past interactions, social media algorithms can unintentionally limit your exposure to diverse perspectives and generate a fragmented and incomplete understanding of information. Even more concerning, a study of misinformation spread on Twitter analyzing data from 2006 to 2017 found that falsehoods were 70% more likely to be shared than the truth and spread “further, faster, deeper and more broadly than the truth” across all categories of information.

The average kindergarten student sees about 70 media messages every day. By the time they’re in high school, teens spend more than a third of their day using media.

How to Identify Misinformation

The lack of robust and standardized regulation of misinformation content on social media places the difficult task of discerning what is true or false information on individual users. We scientists and research entities can also do better in communicating our science and rebuilding trust, as my colleague and I have previously written. I also provide peer-reviewed recommendations for the important roles that parents/caregivers, policymakers and social media companies can play.

Below are some steps that consumers can take to identify and prevent health misinformation spread:

• Check the source. Determine the credibility of the health information by checking if the source is a reputable organization or agency such as the World Health Organization, the National Institutes of Health or the Centers for Disease Control and Prevention. Other credible sources include an established medical or scientific institution or a peer-reviewed study in an academic journal. Be cautious of information that comes from unknown or biased sources.

• Examine author credentials. Look for qualifications, expertise and relevant professional affiliations for the author or authors presenting the information. Be wary if author information is missing or difficult to verify.

• Pay attention to the date. Scientific knowledge by design is meant to evolve as new evidence emerges. Outdated information may not be the most accurate. Look for recent data and updates that contextualize findings within the broader field.

• Cross-reference to determine scientific consensus. Cross-reference information across multiple reliable sources. Strong consensus across experts and multiple scientific studies supports the validity of health information. If a health claim on social media contradicts widely accepted scientific consensus and stems from unknown or unreputable sources, it is likely unreliable.

• Question sensational claims. Misleading health information often uses sensational language designed to provoke strong emotions to grab attention. Phrases like “miracle cure,” “secret remedy” or “guaranteed results” may signal exaggeration. Be alert for potential conflicts of interest and sponsored content.

• Weigh scientific evidence over individual anecdotes. Prioritize information grounded in scientific studies that have undergone rigorous research methods, such as randomized controlled trials, peer review and validation. When done well with representative samples, the scientific process provides a reliable foundation for health recommendations compared to individual anecdotes. Though personal stories can be compelling, they should not be the sole basis for health decisions.

• Talk with a health care professional. If health information is confusing or contradictory, seek guidance from trusted health care providers who can offer personalized advice based on their expertise and individual health needs.

• When in doubt, don’t share. Sharing health claims without validity or verification contributes to misinformation spread and preventable harm.

All of us can play a part in responsibly consuming and sharing information so that the spread of the truth outpaces the false.

Monica Wang, ScD, is an Associate Professor of Community Health Sciences at the Boston University School of Public Health and an Adjunct Associate Professor of Health Policy and Management at the Harvard T.H. Chan School of Public Health. She receives funding from the National Institutes of Health.

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

New Blood Test Could Save Arthritis Patients Time, Money and Pain

By Arthur Allen, KFF Health News

Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.

But the insurer insisted, so Schulte went on Remicade. It didn’t work either.

What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.

After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.

Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.

Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.

“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”

If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.

PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.

Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.

Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.

Insurers Often Determine Treatment

Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.

Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.

Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.

PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.

Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.

Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.

“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”

It’s not only patients and doctors who have a stake in which drugs work best for a given person.

When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.

Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.

Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.

“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”

What Testing Could Do

Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.

“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”

Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.

Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.

“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.

How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.

However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.

Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.

Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.

Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.

Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.

“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”

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

Study Raises Questions About Use of Opioids by Cancer Patients

By Pat Anson, PNN Editor

A new study led by researchers in Australia is raising questions about the effectiveness of prescription opioids in treating cancer pain, saying the evidence from clinical trials is inconclusive or “largely lacking.”

Opioids are a common treatment for cancer pain and are often considered indispensable, particularly near the end of life or in palliative care when pain can be most severe. Virtually all medical guidelines – including the CDC’s – specifically exempt cancer patients from any recommended limits on opioids.

But the new study, published in A Cancer Journal for Clinicians, rejects that long-held medical practice, suggesting that opioids work no better than a placebo in relieving cancer pain and that non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin may be just as good or better.

The study examined findings from over 150 clinical trials involving opioids and cancer, and found that most were not blinded or placebo-controlled. That’s a recurring issue in pain research due to the ethical issues involved in giving patients an ineffective or non-existent analgesic, particularly if they have a terminal illness. Although that shortcoming is widely understood and accepted – the authors of this new study view it as lack of evidence.

“Opioids are the most commonly used treatments for cancer pain management, and, although we might have assumed that there were placebo-controlled trials to support this widespread practice, our findings highlight that the evidence is largely lacking,” wrote lead author Christina Abdel Shaheed, PhD, Senior Academic Fellow at the University of Sydney School of Public Health, Faculty of Medicine and Health.

“There was an absence or paucity of placebo-controlled trials for some of the most commonly used opioid analgesics for cancer pain, including morphine, methadone, buprenorphine, fentanyl, hydromorphone, oxycodone, and tramadol.”

Ironically, Shaheed and her co-authors found that “weaker” opioids such as tapentadol and codeine may work better for cancer pain than the more potent opioids.

They also suggest that NSAIDs and antidepressants are more effective and have fewer side effects for someone with “background” cancer pain who is not nearing the end of life. In effect, they’re saying that opioids are only good if you’re dying.

“In practice, opioids are indispensable for intractable pain and distress at the end of life. What is worth highlighting is that non-opioids, particularly NSAIDs, are surprisingly effective for some cancer pain, and may avoid the problems of dependence and waning opioid analgesia over time,” said co-author Jane Ballantyne, MD, a retired anesthesiologist and professor at the University of Washington.

Ballantyne is Vice President of Clinical Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that advised the CDC during the drafting of its controversial 2016 opioid guideline. Like several other PROP members, Ballantyne has worked as a paid expert witness for law firms involved in opioid litigation.

This is not the first time Ballantyne has said that opioids should be used more cautiously when cancer patients are not terminally ill. In 2007, she wrote an op/ed saying that cancer treatment and survival rates had improved so much that opioids should no longer be viewed as the go-to treatment for cancer pain.  

“Cancer was once an explosive, typically terminal disease and became the prototype for end-of-life opioid pain treatment. However, cancer is no longer such an explosive disease, and many cancer sufferers can now expect to have a prolonged, even normal, lifespan. They may need pain treatment, but this treatment should not be modeled on palliative care paradigms,” Ballantyne wrote.

Many cancer patients are already struggling to get pain relief. A recent study found the number of cancer patients seeking treatment for pain in U.S. emergency departments has doubled in recent years. Nearly half of those ER visits were deemed preventable -- meaning they could have been avoided if the patient has received proper pain care earlier.

Other studies have documented how opioid prescriptions and doses have declined significantly for U.S. cancer patients. The Cancer Action Network warned there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” 

Are you a pain patient who has trouble getting your opioid prescriptions filled? There’s still time to take PNN’s survey on how opioid shortages are affecting patients at pharmacies. Click here to take the survey, which should only take a few minutes.