Is the Opioid Epidemic Really Ending?

By Dr. Charles LeBaron 

From all the self-congratulations by outgoing Biden administration officials about a 15% decrease in overdose deaths last year, one might conclude that the opioid epidemic is coming to an end. However, drug overdoses remain the #1 killer of adults aged 15 to 45, causing more deaths than automobiles and firearms combined.

So even if this “disappearing epidemic” continues at its current pace – about 98,000 fatal overdoses annually -- nearly a million Americans will die of overdoses within the next ten years. 

The carnage is taking place amid a startling paradox: many severely ill persons with a clearly legitimate need for pain control have grave difficulties obtaining opioid medications adequate to make their existence less of a living hell. This worst-case scenario is the legacy of past policy failures – failures that need not be repeated, if incoming Trump administration officials can take a moment to consult our history and apply its lessons. 

In the 1990s, as has been extensively chronicled, large pharmaceutical companies began aggressively promoting proprietary opioid preparations. By the mid-2010s, the United States, with 5% of the world’s population, was estimated to consume 80% of the world’s opioids. For Americans recovering from surgery, 91% received opioids, compared to just 5% in the rest of the world for the same operations.  

Opioid overdose deaths rose in parallel to opioid prescriptions – which became so numerous that the number of pills prescribed was technically enough to kill every American. Whereupon the Centers for Disease Control and Prevention (CDC) stepped in. The CDC’s 2016 opioid guideline, developed with almost no meaningful input from clinicians who treat pain, laid out a series of recommendations on who should get opioids, at what dosage, and for what duration. 

Essentially no attention was paid at the time to antidotes for overdoses or the treatment of dependence. Public and private insurers, eager for cost savings, rapidly adopted the CDC’s dosage restrictions, as did pharmacy chains under attack for their lucrative role in opioid sales. The Drug Enforcement Administration also lent a hand by imposing manufacturing caps on the five major opioid pain medications.  

Within two years, opioid prescribing rates had decreased dramatically in major specialties: for primary care clinicians they dropped 40%, cancer specialists down 60%, and ER docs down 71%. Overall prescription rates fell back to 1990s levels. Success was proclaimed. 

‘Inhuman Punishment’

Then the full consequences of inflexible dosage limits by non-clinicians became apparent. More than 80% of chronic pain patients said they now had more pain and a worse quality of life. The number of cancer patients and survivors with opioid prescriptions decreased by more than half. Suicides by patients cut off from opioids increased. And almost 80% of primary care physicians reported they were reluctant to prescribe opioids for any reason.  

Even when opioids were prescribed, patients often found that their opioid medication was unavailable because of the artificial scarcity created by opioid litigation and the DEA’s manufacturing caps. Patient and professional organizations protested. A group of 274 academic experts (including two former “drug czars”) sent a protest petition to CDC.  

Human Rights Watch, an organization best known for exposing torture by totalitarian regimes, issued a hundred-page report, suggesting that CDC policies could be considered to violate basic human rights by imposing “cruel, degrading, and inhuman punishment” on those whose only crime was to be in severe pain.  

But CDC held the line, pointing proudly to a drop of a few percent in the 2018 overdose rate. Lost in the triumphalism was the fact that the overdose rate was creeping up from a little-known opioid called fentanyl, which is 100 times more potent than morphine.

The 2018 overdose downturn proved to be a pause, during which a new set of entrepreneurs entered the market, acquiring fentanyl components from suppliers in China, using pill presses to make them look like FDA-approved medications, and then transporting them to a gig distribution system in the US.

The Mexican cartels were meeting an unmet need. The pharmaceutical companies had helped create the need. And rigid implementation of the restrictive CDC guidelines, aided by DEA manufacturing caps, helped assure the need went unmet.

Overdoses, primarily from illicit fentanyl, exploded after the 2018 pause, doubling in the six years following implementation of the CDC recommendations, a surge particularly acute right in the CDC’s own backyard of Georgia.

So here we are in 2025, with a few percent reduction in overdoses and once again a repetition of 2018 triumphalism.

Meanwhile, overdoses have increased seven-fold from illicit carfentanil, a veterinary opioid so potent that a delivery box could overdose the entire US population.

We remain in the paradoxical situation where evermore dangerous illicit opioids from abroad are easily purchased on a street corner, while medically-prescribed opioids, manufactured under the FDA’s safety and purity standards, are hard to obtain by those who legitimately need them.

We Could Do Better

I worked for more than 28 years at CDC as an epidemic control specialist, during which time I also did clinical work with addicts and drug dealers in Appalachia and in the federal penal system.

Several years ago, as a patient with life-threatening staph spinal abscesses, I received months of high-dose opioids for severe pain. Many pain patients wake up each morning, as I did then, praying that the day’s struggle for some semblance of pain control will succeed against odds that seem so perversely, so specifically, so implacably stacked against them.

Out of these personal and professional experiences, I concluded that we could do better by the millions currently in severe inescapable pain, as well as the million projected to die by overdose in the upcoming decade. I wrote a book about the opioid crisis, "Greed to Do Good: The Untold Story of CDC's Disastrous War on Opioids."

In brief, here’s what I suggest should be minimal elements of an effective opioid epidemic response:

• We have an ongoing mass poisoning. We have an antidote. Naloxone (Narcan) should be deployed on a scale equivalent to the mass poisoning.

• For the estimated 50 million Americans with chronic pain, and especially the 17 million for whom pain limits life and basic functioning, opioids prescribed by a physician should not be so difficult to obtain that patients turn to cartels as America’s pharmacist.

• Standards guiding pain treatment should come from medical organizations with clinical expertise – not from pharmaceutical marketers, government bureaucrats, or the police.

• Artificial scarcity for legitimate opioids through DEA caps on manufacturing merely shifts demand to illicit opioids. This policy should be abandoned.

• For the estimated 6 million Americans with opioid use disorder, only 20% are in treatment. Addiction is a relapsing-remitting condition, with treatment outcomes similar to those for other chronic conditions, such as diabetes, asthma and hypertension, where behavioral setbacks are also common. To really wreak havoc on cartel profits, while saving American taxpayers millions of dollars in unnecessary incarceration costs, treatment needs to be made as accessible as it is for other chronic conditions

One-in-ten American families has lost an immediate family member to a drug overdose. The dead are our brothers, sisters, husbands, wives, children and newborns. The sooner we recognize that our policies result in more deaths and more persons in pain, the sooner we will bring this self-inflicted massacre to a close. 

A graduate of Princeton University and Harvard Medical School, Charles W. LeBaron, MD, is board certified in both internal medicine and pediatrics. For more than 28 years, he worked as a medical epidemiologist at the CDC.  

Dr. LeBaron’s book “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids” can be purchased from online booksellers or the publisher (Amplify Publishing in Herndon VA). For book reviews, see Kirkus or BlueInk.

Long Covid Patients Frustrated by Lack of New Treatments

By Sarah Boden, KFF Health News

Erica Hayes, 40, has not felt healthy since November 2020 when she first fell ill with covid.

Hayes is too sick to work, so she has spent much of the last four years sitting on her beige couch, often curled up under an electric blanket.

“My blood flow now sucks, so my hands and my feet are freezing. Even if I’m sweating, my toes are cold,” said Hayes, who lives in Western Pennsylvania. She misses feeling well enough to play with her 9-year-old son or attend her 17-year-old son’s baseball games.

Along with claiming the lives of 1.2 million Americans, the covid-19 pandemic has been described as a mass disabling event. Hayes is one of millions of Americans who suffer from long covid.

Depending on the patient, the condition can rob someone of energy, scramble the autonomic nervous system, or fog their memory, among many other symptoms.

In addition to the brain fog and chronic fatigue, Hayes’ constellation of symptoms includes frequent hives and migraines. Also, her tongue is constantly swollen and dry.

“I’ve had multiple doctors look at it and tell me they don’t know what’s going on,” Hayes said about her tongue. 

ERICA HAYES

Estimates of prevalence range considerably, depending on how researchers define long covid in a given study, but the Centers for Disease Control and Prevention puts it at 17 million adults.

Despite long covid’s vast reach, the federal government’s investment in researching the disease — to the tune of $1.15 billion as of December — has so far failed to bring any new treatments to market. 

This disappoints and angers the patient community, who say the National Institutes of Health should focus on ways to stop their suffering instead of simply trying to understand why they’re suffering.

“It’s unconscionable that more than four years since this began, we still don’t have one FDA-approved drug,” said Meighan Stone, executive director of the Long COVID Campaign, a patient-led advocacy organization. Stone was among several people with long covid who spoke at a workshop hosted by the NIH in September where patients, clinicians, and researchers discussed their priorities and frustrations around the agency’s approach to long-covid research.

Some doctors and researchers are also critical of the agency’s research initiative, called RECOVER, or Researching COVID to Enhance Recovery. Without clinical trials, physicians specializing in treating long covid must rely on hunches to guide their clinical decisions, said Ziyad Al-Aly, chief of research and development with the VA St Louis Healthcare System.

“What [RECOVER] lacks, really, is clarity of vision and clarity of purpose,” said Al-Aly, saying he agrees that the NIH has had enough time and money to produce more meaningful progress.

Now the NIH is starting to determine how to allocate an additional $662 million of funding for long-covid research, $300 million of which is earmarked for clinical trials. These funds will be allocated over the next four years. At the end of October, RECOVER issued a request for clinical trial ideas that look at potential therapies, including medications, saying its goal is “to work rapidly, collaboratively, and transparently to advance treatments for Long COVID.”

This turn suggests the NIH has begun to respond to patients. This has stirred cautious optimism among those who say that the agency’s approach to long covid has lacked urgency in the search for effective treatments. Stone calls this $300 million a down payment. She warns it’s going to take a lot more money to help people like Hayes regain some degree of health.“There really is a burden to make up this lost time now,” Stone said.

The NIH told KFF Health News and NPR via email that it recognizes the urgency in finding treatments. But to do that, there needs to be an understanding of the biological mechanisms that are making people sick, which is difficult to do with post-infectious conditions.

That’s why it has funded research into how long covid affects lung function, or trying to understand why only some people are afflicted with the condition.

Good Science Takes Time

In December 2020, Congress appropriated $1.15 billion for the NIH to launch RECOVER, raising hopes in the long-covid patient community.

Then-NIH Director Francis Collins explained that RECOVER’s goal was to better understand long covid as a disease and that clinical trials of potential treatments would come later.

According to RECOVER’s website, it has funded eight clinical trials to test the safety and effectiveness of an experimental treatment or intervention. Just one of those trials has published results.

On the other hand, RECOVER has supported more than 200 observational studies, such as research on how long covid affects pulmonary function and on which symptoms are most common. And the initiative has funded more than 40 pathobiology studies, which focus on the basic cellular and molecular mechanisms of long covid.

RECOVER’s website says this research has led to crucial insights on the risk factors for developing long covid and on understanding how the disease interacts with preexisting conditions. It notes that observational studies are important in helping scientists to design and launch evidence-based clinical trials.

Good science takes time, said Leora Horwitz, the co-principal investigator for the RECOVER-Adult Observational Cohort at New York University. And long covid is an “exceedingly complicated” illness that appears to affect nearly every organ system, she said. 

This makes it more difficult to study than many other diseases. Because long covid harms the body in so many ways, with widely variable symptoms, it’s harder to identify precise targets for treatment.

“I also will remind you that we’re only three, four years into this pandemic for most people,” Horwitz said. “We’ve been spending much more money than this, yearly, for 30, 40 years on other conditions.”

NYU received nearly $470 million of RECOVER funds in 2021, which the institution is using to spearhead the collection of data and biospecimens from up to 40,000 patients. Horwitz said nearly 30,000 are enrolled so far.

This vast repository, Horwitz said, supports ongoing observational research, allowing scientists to understand what is happening biologically to people who don’t recover after an initial infection — and that will help determine which clinical trials for treatments are worth undertaking.

“Simply trying treatments because they are available without any evidence about whether or why they may be effective reduces the likelihood of successful trials and may put patients at risk of harm,” she said.

‘I’m Just Disgusted’

The NIH told KFF Health News and NPR that patients and caregivers have been central to RECOVER from the beginning, “playing critical roles in designing studies and clinical trials, responding to surveys, serving on governance and publication groups, and guiding the initiative.” But the consensus from patient advocacy groups is that RECOVER should have done more to prioritize clinical trials from the outset. Patients also say RECOVER leadership ignored their priorities and experiences when determining which studies to fund.

RECOVER has scored some gains, said JD Davids, co-director of Long COVID Justice. This includes findings on differences in long covid between adults and kids. But Davids said the NIH shouldn’t have named the initiative “RECOVER,” since it wasn’t designed as a streamlined effort to develop treatments.

“The name’s a little cruel and misleading,” he said.

RECOVER’s initial allocation of $1.15 billion probably wasn’t enough to develop a new medication to treat long covid, said Ezekiel J. Emanuel, co-director of the University of Pennsylvania’s Healthcare Transformation Institute.

But, he said, the results of preliminary clinical trials could have spurred pharmaceutical companies to fund more studies on drug development and test how existing drugs influence a patient’s immune response.

Emanuel is one of the authors of a March 2022 covid roadmap report. He notes that RECOVER’s lack of focus on new treatments was a problem. “Only 15% of the budget is for clinical studies. That is a failure in itself — a failure of having the right priorities,” he told KFF Health News and NPR via email.

And though the NYU biobank has been impactful, Emanuel said there needs to be more focus on how existing drugs influence immune response.

He said some clinical trials that RECOVER has funded are “ridiculous,” because they’ve focused on symptom amelioration, for example to study the benefits of over-the-counter medication to improve sleep. Other studies looked at non-pharmacological interventions, such as exercise and “brain training” to help with cognitive fog.

People with long covid say this type of clinical research contributes to what many describe as the “gaslighting” they experience from doctors, who sometimes blame a patient’s symptoms on anxiety or depression, rather than acknowledging long covid as a real illness with a physiological basis.

“I’m just disgusted,” said long-covid patient Hayes. “You wouldn’t tell somebody with diabetes to breathe through it.”

Chimére L. Sweeney, director and founder of the Black Long Covid Experience, said she’s even taken breaks from seeking treatment after getting fed up with being told that her symptoms were due to her diet or mental health.

“You’re at the whim of somebody who may not even understand the spectrum of long covid,” Sweeney said.

Insurance Battles Over Experimental Treatments

Since there are still no long-covid treatments approved by the Food and Drug Administration, anything a physician prescribes is classified as either experimental — for unproven treatments — or an off-label use of a drug approved for other conditions. This means patients can struggle to get insurance to cover prescriptions.

Michael Brode, medical director for UT Health Austin’s Post-COVID-19 Program — said he writes many appeal letters. And some people pay for their own treatment.

For example, intravenous immunoglobulin therapy, low-dose naltrexone, and hyperbaric oxygen therapy are all promising treatments, he said.

For hyperbaric oxygen, two small, randomized controlled studies show improvements for the chronic fatigue and brain fog that often plague long-covid patients. The theory is that higher oxygen concentration and increased air pressure can help heal tissues that were damaged during a covid infection.

However, the out-of-pocket cost for a series of sessions in a hyperbaric chamber can run as much as $8,000, Brode said.

“Am I going to look a patient in the eye and say, ‘You need to spend that money for an unproven treatment’?” he said. “I don’t want to hype up a treatment that is still experimental. But I also don’t want to hide it.”

There’s a host of pharmaceuticals that have promising off-label uses for long covid, said microbiologist Amy Proal, president and chief scientific officer at the Massachusetts-based PolyBio Research Foundation. For instance, she’s collaborating on a clinical study that repurposes two HIV drugs to treat long covid.

Proal said research on treatments can move forward based on what’s already understood about the disease. For instance, she said that scientists have evidence — partly due to RECOVER research — that some patients continue to harbor small amounts of viral material after a covid infection. She has not received RECOVER funds but is researching antivirals.

But to vet a range of possible treatments for the millions suffering now — and to develop new drugs specifically targeting long covid — clinical trials are needed. And that requires money.

Hayes said she would definitely volunteer for an experimental drug trial. For now, though, “in order to not be absolutely miserable,” she said she focuses on what she can do, like having dinner with her family. At the same time, Hayes doesn’t want to spend the rest of her life on a beige couch. 

RECOVER’s deadline to submit research proposals for potential long-covid treatments is Feb. 1.

(Update: The Trump administration recently ordered an “immediate pause” on all communications, reports, scientific meetings, and funding reviews by federal health agencies. It’s not clear how long the order will last or affect long covid research.)

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

How I Set Up My Daily Life To Manage Chronic Pain

By Crystal Lindell

I’ve been dealing with severe chronic pain for more than a decade now, most of which is due to the intercostal neuralgia I have in my ribs. So, at this point, my entire life is basically set up to accommodate that. 

While some people may read that paragraph and assume that I have a sad life consumed by pain, I prefer to think of it as my way of fighting back. 

By planning for and accepting my pain, I can live without added stress and burdens. As a result, I don’t let my pain lead – instead I get to lead my pain. 

My daily schedule is flexible, so that I can adjust it to my pain as I’m able, doing more when I can and resting when I need to. I keep things as stress-free as possible because stress escalates my pain. And I try to work with my body instead of against it. 

So what does that look like on a typical day in my life?

Well, I usually wake up for the first time at around 4:30 am to the sound of my orange cat Goose screaming at the top of his lungs because he’s hungry. I take a second to see how much my back hurts today and decide the best method for getting out of bed. My goal is always to get out of bed without needing help from my fiancé Chris.

Then I go to the kitchen to feed Goose and our other three cats – Princess D, Basil, and Goldie. I love them, so they get wet food before I even eat my own morning breakfast: Two Advil; one pain pill; a spoonful of kratom washed down with orange Gatorade; and a cup of hot coffee. 

I go to sleep at about 8 pm most nights, so I check my phone first thing to catch up on any messages I get from loved ones overnight. I also throw the news on our TV so I can catch up on the slew of horrible things that likely happened in the world overnight. 

After “breakfast” I lay out a yoga mat and grab my pillow so I can lay on the floor for a bit as the news continues in the background. There’s something about laying on the ground that helps alleviate the vicious back pain I’ve been dealing with ever since throwing out my back a few weeks ago.

Anytime I try to skip this new floor ritual, I regret it, so I have now built it into my daily schedule to stare at the ceiling multiple times a day. Our black cat Basil always curiously crawls around my head wondering what I’m doing in her realm of the house – the floor. 

Then I get the food dishes ready for the outside cats that I take care of and run those outside to help them survive the long, cold Midwest winter. 

Depending on how busy my day ahead is, I’ll then sometimes lay down for another hour or so while letting my morning medication cocktail kick in. 

When I get back up, I make another cup of coffee, which usually ends up sitting half-finished on our coffee table until it gets cold and I give up on it. Despite the fact that this happens almost every day, I still keep making that second cup of coffee thinking today will be the day I finally finish it.

I don’t work full time in large part due to my health, so I don’t have to get ready to leave the house most days. But that doesn’t mean I just sit around watching TikTok all day. I make ends meet by doing freelance writing work, and by running an online Lego store with Chris via a website called Bricklink. 

If I have writing assignments due, I start mulling that over in my brain, while simultaneously checking in on our Bricklink store to see if any orders came in overnight. Chris handles most of the packing and shipping, but if we are especially busy, I jump in and help pull orders. 

Because my rib pain gets worse the longer I’m awake, I also try to cook any food for the day in the morning because cooking is a very draining task in and of itself. That means I’ll often start a pot of soup or a casserole by 9 a.m. Personally, I actually like dinner food for breakfast, so depending on how long that takes to make, I’ll generally have a serving to start my day. 

I also try to make double batches of any meals, and then freeze them in a portion-size silicone ice cube tray to essentially make my own homemade frozen dinners. That way, when I’m having an especially bad pain day, I have quick meal options. 

After cooking, I head to my couch and figure out the rest of my plans for the day.

This time of year, when the temperatures here in northern Illinois are almost always below freezing, I do a lot of life from my couch under a heated blanket, with our long-hair tortoiseshell cat Princess D on my shoulder. 

Sometimes that means I even do some writing directly on my phone, if I’m in too much pain to pull out my laptop. 

After a few hours of work, I usually have another round of ibuprofen, prescription pain meds, and kratom in the afternoon with my lunch, which is often another serving of whatever food I made that morning. 

CRYSTAL AND PRINCESS D

Then I’ll try to shower. I don’t know if it’s because of the way that I have to move my arms to wash my hair or because there’s just a lot of standing involved, but showers genuinely wipe me out, so I have to set aside time to both take a shower and then recover for a bit on the couch.  After I get dressed, I have to lay on the floor again for about 15 minutes for my back. 

Most days I wear extremely comfortable clothing because I can’t risk any additional discomfort to my ailing body. So if I’m staying home for the day I’ll just directly opt for pajamas, but if I’m visiting my mom — who lives a couple blocks away — I’ll throw on some lounge pants and T-shirt.

In both cases though, I’ll also throw on some compression socks just to keep my feet from swelling up because of all the ibuprofen I take. 

I’ll also throw on some very light makeup just to give myself a little pick me up. Then, I will often run over to my mom’s house to drop off some food for her and my grandma to eat for dinner.

After I get home, I’ll spend time catching up on social media, which helps me feel like I have a social life despite the fact that I spend most of my time at home. 

I also am still trying to avoid catching COVID because I don’t want to risk adding to my health issues, so I limit my time at large social gatherings as much as possible. That means most of my communication with loved ones is via text and the occasional FaceTime call. 

So I take some time in the later afternoon on the couch, while Chris rubs my feet, to catch up with people I care about while also playing the daily New York Times Connections and Wordle Games. 

Part of running the Bricklink store means that, aside from pulling orders, our other big task is adding Lego parts to our inventory, so I try to work on that in the evening before feeding the cats dinner and then winding down the night. 

Then, like I said, I’m in bed by about 8 pm because dealing with chronic pain is exhausting. So after one last round of Advil, pain medication, and kratom, I’ll get under the heated blanket in our bed and scroll social media on my phone for a bit before falling asleep with our tabby cat Goldie cuddled up next to my head.

I could see how a healthy person might read this day-in-the-life story and come away thinking I have a pretty plain existence. But I love spending my days in my cozy, small-town apartment, cuddling my cats on-demand and running an online Lego store with my fiancé. 

It’s back when I was trying to pretend that pain didn’t exist that I was miserable, constantly overdoing it, and ending up either in the emergency room sobbing in pain, or at home awake all night with pain-somnia. 

Pain forces you to go with the flow, to embrace the world as it is and work with it, instead of against it. It’s only when I accepted that fact, that I found true happiness. 

Note: Pain News Network makes a small commission on any Amazon links in this article. 

Where Have All the Pain Doctors Gone?

By Pat Anson

In recent years, it’s become increasingly difficult for a patient in pain to find a new doctor. Many physicians have stopped treating pain, retired early or switched specialties, rather than run the risk of being investigated or even put in prison for prescribing opioids.

In a recent PNN survey, one in five patients said they couldn’t find a doctor to treat their pain. Others said they were abandoned or discharged by a physician (12%) or had a doctor who retired from clinical practice (14%).   

“All the doctors in this area are justifiably terrified to involve themselves at all with opiates,” one patient told us. “It's now going on 6 months that I've been hunting for a doctor who isn't afraid to continue my former opiate regimen, which only made my pain tolerable, allowing me some small quality of life. I don't know what to do next and I am truly at my wits end.”

“This year my doctor retired, then 8 months later the hospital closed the pain clinic. I'm waiting to get into a new pain clinic that is 200 miles away. Every local doctor refuses to prescribe my pain meds, so now I'm forced to travel 4 hours each way to see a new doctor,” another patient said.

“I have to fly to another state for my medical care,” said another person in pain. “Many patients I’ve met over the last ten years have not had the same care. They can’t afford the medical treatment and can’t find doctors to help.”

A new study suggests the problem is only going to get worse, because medical schools are seeing fewer anesthesiology residents applying for fellowships in pain medicine. The number of applications fell 45% from 2019 to 2023.

“While the demand for pain specialists is growing in the U.S., the pipeline of new doctors to fill these roles is drying up,” says lead author Scott Pritzlaff, MD, an associate professor in the UC Davis Department of Anesthesiology and Pain Medicine and director of the school’s Pain Medicine Fellowship program.

Pritzlaff and his colleagues analyzed data from the National Resident Matching Program (NRMP), Electronic Residency Application Service (ERAS) and a special report from the American Association of Medical Colleagues (AAMC) to see trends in medical specialties.

Their findings, recently published in the journal Pain Practice, show significant changes in specialties that are being driven by market forces and professional preferences. While demand and pay scales for general anesthesiologists have increased, the number of anesthesiology trainees applying for pain medicine fellowships is dropping. The trend is most notable among female residents applying for the specialty, which has fallen by 27.5%, compared to a 9.8% decline in male applicants.

“Fewer doctors choosing pain medicine means longer wait times, rushed care and fewer treatment options for patients suffering from chronic pain,” Pritzlaff said. “In a country already grappling with an opioid crisis, this could leave millions without the specialized care they need to manage their pain safely and effectively.”

Co-author Chinar Sanghvi, MD, says the drop in applications is partially driven by opioid lawsuits against drug makers and criminal cases against doctors, which have made medical residents and trainees leery about practicing pain medicine.

“For trainees observing this during their formative years, it may have created a perception of pain medicine as a high-risk specialty — both legally and ethically,” said Sanghvi, an assistant clinical professor in the UC Davis Department of Anesthesiology who mentors first and second year-medical students. “This fear of litigation, coupled with the stigma surrounding opioid prescribing, could discourage aspiring physicians from entering the field.”

The data also revealed some upward trends. Applications from residents for physical medicine and rehabilitation fellowships rose almost 33%, while residents specializing in emergency medicine increased by 190%.

General anesthesiologists have some of the best paying jobs in medicine, with median salaries of nearly $499,000 a year. For an anesthesiologist to specialize in pain medicine requires an additional year of training and pays less. With high demand and higher salaries, many doctors skip the extra training and enter the workforce right after completing their anesthesiology residency.

To help attract new residents, the UC Davis Health Division of Pain Medicine increased its recruiting efforts and became more active on social media. The efforts helped UC Davis fill its fellowship slots in pain medicine despite the national downturn.

“Pain medicine is caught in a strange paradox. On one hand, pain is one of the biggest public health problems in America, costing billions annually. On the other, the field is underappreciated and underfunded,” said senior author David Copenhaver, MD, a professor in the UC Davis Department of Anesthesiology and Pain Medicine and chief of the Division of Pain Medicine. “This decline isn’t just about numbers — it’s a wake-up call for the future of pain care in America.”

Trump’s Early Moves Could Raise Drug Costs and Reduce Insurance Coverage

By Julie Appleby and Stephanie Armour, KFF Health News

President Donald Trump’s early actions on health care signal his likely intention to wipe away some Biden-era programs to lower drug costs and expand coverage under public insurance programs.

The orders he issued soon after reentering the White House have policymakers, health care executives, and patient advocates trying to read the tea leaves to determine what’s to come. The directives, while less expansive than orders he issued at the beginning of his first term, provide a possible road map that health researchers say could increase the number of uninsured Americans and weaken safety-net protections for low-income people.

However, Trump’s initial orders will have little immediate impact. His administration will have to take further regulatory steps to fully reverse Biden’s policies, and the actions left unclear the direction the new president aims to steer the U.S. health care system.

“Everyone is looking for signals on what Trump might do on a host of health issues. On the early EOs, Trump doesn’t show his cards,” said Larry Levitt, executive vice president for health policy at KFF, the health policy research, polling, and news organization that includes KFF Health News.

A flurry of executive orders and other actions Trump issued on his first day back in office included rescinding directives by his predecessor, former President Joe Biden, that had promoted lowering drug costs and expanding coverage under the Affordable Care Act and Medicaid.

Executive orders “as a general matter are nothing more than gussied up internal memoranda saying, ‘Hey, agency, could you do something?’” said Nicholas Bagley, a law professor at the University of Michigan. “There may be reason to be concerned, but it’s down the line.”

That’s because making changes to established law like the ACA or programs like Medicaid generally requires new rulemaking or congressional action, either of which could take months.

Trump has yet to win Senate confirmation for any of his picks to lead federal health agencies, including Robert F. Kennedy Jr., the anti-vaccine activist and former Democratic presidential candidate he has nominated the lead the Department of Health and Human Services. On Monday, he appointed Dorothy Fink, a physician who directs the HHS Office on Women’s Health, as acting secretary for the department.

During Biden’s term, his administration did implement changes consistent with his health orders, including lengthening the enrollment period for the ACA, increasing funding for groups that help people enroll, and supporting the Inflation Reduction Act, which boosted subsidies to help people buy coverage. After falling during the Trump administration, enrollment in ACA plans soared under Biden, hitting record highs each year. More than 24 million people are enrolled in ACA plans for 2025.

The drug order Trump rescinded called on the Centers for Medicare & Medicaid Services to test ways to lower drug costs, such as setting a flat $2 copay for some generic drugs in Medicare, the health program for people 65 and older, and having states try to get better prices by banding together to buy certain expensive cell and gene therapies.

That might indicate Trump expects to do less on drug pricing this term or even roll back drug price negotiation in Medicare.

The White House did not respond to a request for comment.

Biden’s experiments in lowering drug prices didn’t fully get off the ground, said Joseph Antos of the American Enterprise Institute, a right-leaning research group. Antos said he’s a bit puzzled by Trump’s executive order ending the pilot programs, given that he has backed the idea of tying drug costs in the U.S. to lower prices paid by other nations.

“As you know, Trump is a big fan of that,” Antos said. “Lowering drug prices is an easy thing for people to identify with.”

In other moves, Trump also rescinded Biden orders on racial and gender equity and issued an order asserting that there are only two sexes, male and female. HHS under the Biden administration supported gender-affirming health care for transgender people and provided guidance on civil rights protections for transgender youths. Trump’s missive on gender has intensified concerns within the LGBTQ+ community that he will seek to restrict such care.

“The administration has forecast that it will fail to protect and will seek to discriminate against transgender people and anyone else it considers an ‘other,’” said Omar Gonzalez-Pagan, senior counsel and health care strategist at Lambda Legal, a civil rights advocacy group.

“We stand ready to respond to the administration’s discriminatory acts, as we have previously done to much success, and to defend the ability of transgender people to access the care that they need, including through Medicaid and Medicare.”

Trump also halted new regulations that were under development until they are reviewed by the new administration. He could abandon some proposals that were yet to be finalized by the Biden administration, including expanded coverage of anti-obesity medications through Medicare and Medicaid and a rule that would limit nicotine levels in tobacco products, Katie Keith, a Georgetown University professor who was deputy director of the White House Gender Policy Council under Biden, wrote in an article for Health Affairs Forefront.

“Interestingly, he did not disturb President Biden’s three executive orders and a presidential memorandum on reproductive health care,” she wrote.

However, Trump instructed top brass in his administration to look for additional orders or memorandums to rescind. (He revoked the Biden order that created the Gender Policy Council.)

Democrats criticized Trump’s health actions. A spokesman for the Democratic National Committee, Alex Floyd, said in a statement that “Trump is again proving that he lied to the American people and doesn’t care about lowering costs — only what’s best for himself and his ultra-rich friends.”

Medicaid Cuts

Trump’s decision to end a Biden-era executive order aimed at improving the ACA and Medicaid probably portends coming cuts and changes to both programs, some policy experts say. His administration previously opened the door to work requirements in Medicaid — the federal-state program for low-income adults, children, and people with disabilities — and previously issued guidance enabling states to cap federal Medicaid funding. Medicaid and the related Children’s Health Insurance Program cover more than 79 million people.

“Medicaid will be a focus because it’s become so sprawling,” said Chris Pope, a senior fellow at the Manhattan Institute, a conservative policy group. “It’s grown after the pandemic. Provisions have expanded, such as using social determinants of health.”

The administration may reevaluate steps taken by the Biden administration to allow Medicaid to pay for everyday expenses some states have argued affect its beneficiaries’ health, including air conditioners, meals, and housing.

One of Trump’s directives orders agencies to deliver emergency price relief and “eliminate unnecessary administrative expenses and rent-seeking practices that increase healthcare costs.” (Rent-seeking is an economic concept describing efforts to exploit the political system for financial gain without creating other benefits for society.)

“It is not clear what this refers to, and it will be interesting to see how agencies respond,” Keith wrote in her Health Affairs article.

Policy experts like Edwin Park at Georgetown University have also noted that, separately, Republicans are working on budget proposals that could lead to large cuts in Medicaid funding, in part to pay for tax cuts.

Sarah Lueck, vice president for health policy at the Center on Budget and Policy Priorities, a left-leaning research group, also pointed to Congress: “On one hand, what we see coming from the executive orders by Trump is important because it shows us the direction they are going with policy changes. But the other track is that on the Hill, there are active conversations about what goes into budget legislation. They are considering some pretty huge cuts to Medicaid.”

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

Walgreens Joins CVS in Fighting DOJ Opioid Lawsuits

By Crystal Lindel

Walgreens is fighting back against a new Department of Justice lawsuit, using a tactic that mirrors CVS’s public response to a similar DOJ lawsuit filed last month. 

In both lawsuits, the DOJ claims that Walgreens and CVS knowingly filled “unlawful prescriptions” for opioids and other controlled substances, and then sought reimbursement for them from federal healthcare programs like Medicaid and Medicare.

CVS and Walgreens are also accused of pressuring their pharmacists into filling prescriptions for opioids and other controlled substances without a thorough review. 

In a statement however, Walgreens said many of the federal rules governing pharmacies are so vague as to be impossible to follow. 

“We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rulemaking process,” Walgreens said. “We will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with ‘rules’ that simply do not exist.

“Walgreens stands behind our pharmacists, dedicated healthcare professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations.”

Both CVS and Walgreens are accused of filling prescriptions for “dangerous and excessive quantities of opioids,” filling prescriptions too early, and filling prescriptions for opioids, benzodiazepines and muscle relaxants, a three-drug combination known as the “Holy Trinity” that the feds consider dangerous.

The DOJ alleges that, from 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances that lacked a “legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice.” The complaint against CVS is nearly identical.

It’s noteworthy that the DOJ claims that both Walgreens and CVS have been filling these prescriptions “through the present,” because when it comes to getting an opioid prescription filled, pain patients find CVS and Walgreens to be the two most difficult pharmacies to work with. 

In 2023, PNN conducted a large survey of nearly 3,000 pain patients, and when respondents were asked which pharmacy chain was the most difficult to get an opioid prescription filled, more than half the patients in our survey selected either Walgreens (30%) or CVS (26%). 

“Every month when I have to get my medication renewed there is always an issue,” explained one patient. “Walgreens always give people a hard time. I've seen many people standing in line and just walk out.” 

“CVS continually gives me a hard time to fill my Rx even though I have been on it for over 7 years. It is either out of stock, or they argue with me about filling it,” another patient told us.

That difficulty is likely tied to the fact that Walgreens and CVS signed the National Opioid Settlement in 2022. As part of the settlement, they agreed to pay more than $10 billion to states, cities and counties that sued them for their alleged roles in causing the opioid epidemic. 

The nation’s two biggest pharmacy chains also agreed to watch for suspicious orders, report any “problematic” prescribers, and to strictly limit the amount of opioid pain medication they can dispense in any given month.

Opioids, in effect, are now being rationed to their customers, yet the DOJ is claiming that both pharmacies continue to fill opioid prescriptions too easily. 

As a pain patient, I use a small local pharmacy specifically to avoid the issues that are common for patients at large pharmacy chains like Walgreens and CVS. However, that alone doesn’t protect me. When the DOJ goes after large pharmacies, the fear trickles down to the smaller ones as well. 

Nearly every month I have some issue getting my prescription filled. They claim they can’t find the prescription in their system, and only “find it” after I go back and forth with them and my doctor on multiple phone calls. Or they claim it’s out of stock, which unfortunately I have no way of checking to see if they’re telling the truth. 

Just yesterday I spent all day trying to get my pain medication refilled because the pharmacist claimed she accidentally deleted it from the system. I had to get my doctor to resend it. 

Dealing with chronic pain is a struggle in and of itself. The last thing pain patients need is another battle to fight at the pharmacy. If Walgreens and CVS are unsuccessful in fighting back against their respective DOJ lawsuits, it’s likely that pain patients will suffer even more as a result. 

RFK Jr. Wants to Create Drug Rehab ‘Wellness Farms’

By Pat Anson

Confirmation hearings for Robert F. Kennedy Jr., President Trump’s nominee to be Secretary of Health and Human Services, are expected to begin next week, with senators likely to ask about his controversial views on vaccines, fluoride, abortion and other hot-button health issues.  

Less well known is Kennedy’s ambitious plan for drug rehabilitation “wellness farms” for people addicted to illicit drugs or prescription medications such as opioids, antidepressants, stimulants and anti-anxiety medications. Kennedy outlined his plans to treat addiction and “re-parent” people with substance use problems during a “Latino Town Hall” last July, when he was running for president and had yet to endorse Trump.

“I’m going to make it so people can go, if you’re convicted of a drug offense, or if you have a drug problem, you can go to one of these places for free,” said Kennedy, adding that he would pay for the wellness farms with a tax on cannabis sales, if and when marijuana is removed as a prohibited Schedule One controlled substance.    

“I’m going to move it off Schedule One and I’m going to start collecting taxes on it. That’s going to bring in $8.5 billion dollars in revenue. I’m going to dedicate that revenue to creating wellness farms, drug rehabilitation farms, in rural areas all over this country.”

Kennedy released a documentary called “Recovering America” last year, in which he tours the country looking for innovative drug treatment programs. The issue is close to his heart because Kennedy was addicted to heroin as a young man. He’s been in recovery for 40 years and regularly attends 12-step meetings.

“We have a whole generation of kids who are dispossessed, they’re alienated, they’re marginalized, their suicide rates are exploding. The second largest killer for young people is drug addiction,” Kennedy said.

“I’m going to create these wellness farms where they can go to get off of illegal drugs, off of opiates, but also legal drugs, psychiatric drugs, if they want to, to get off of SSRIs, to get off of benzos, to get off of Adderall, and to spend time, as much time as they need — three or four years if they need it — to learn to get re-parented, to reconnect with communities, to understand how to talk to people.”

Participants at the wellness farms would also receive job training and grow their own organic food. Kennedy has long blamed pesticides and processed food for America’s “chronic disease epidemic.”

If confirmed as HHS secretary, Kennedy would oversee a vast bureaucracy and supervise agencies such as the Food and Drug Administration, Centers for Medicare and Medicaid Services, National Institutes of Health, and the Centers for Disease Control and Prevention.

It’s not clear what his views are about the CDC’s opioid guideline, which led to many patients in pain losing access to opioids. But Kennedy has been outspoken about the influence drug makers and lobbyists have on public health policy, saying Trump gave him instructions to end the “corruption and the conflicts” at federal health agencies.

“FDA’s war on public health is about to end,” Kennedy wrote in an October 25 tweet. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”

Trump also said he would let Kennedy “go wild” on healthcare, but according to Politico, his transition team is intent on surrounding RFK Jr. at HHS with conservative aides who have more experience in government and remain loyal to Trump.

The Washington Post reported that the Office of Government Ethics is still looking into Kennedy's financial disclosure statements, which were recently amended. That may delay his confirmation hearings until late January.

Anxiety Medications Decline in States Where Marijuana Is Legal

By Ashley Bradford

In states where both medical and recreational marijuana are legal, fewer patients are filling prescriptions for medications used to treat anxiety. That is the key finding of my recent study, published in the journal JAMA Network Open.

I am an applied policy researcher who studies the economics of risky behaviors and substance use within the United States. My collaborators and I wanted to understand how medical and recreational marijuana laws and marijuana dispensary openings have affected the rate at which patients fill prescriptions for anti-anxiety medications among people who have private medical insurance.

These include:

• Benzodiazepines, which work by increasing the level of gamma-aminobutyric acid, or GABA, a neurotransmitter that elicits a calming effect by reducing activity in the nervous system. This category includes the depressants Valium, Xanax and Ativan, among others.

• Antipsychotics, a class of drug that addresses psychosis symptoms in a variety of ways.

• Antidepressants, which relieve symptoms of depression by affecting neurotransmitters such as serotonin, norepinephrine and dopamine. The most well-known example of these is selective serotonin re-uptake inhibitors, or SSRIs.

We also included barbiturates, which are sedatives, and sleep medications – sometimes called “Z-drugs” – both of which are used to treat insomnia. In contrast to the other three categories, we did not estimate any policy impacts for either of these types of drugs.

We find consistent evidence that increased marijuana access is associated with reductions in benzodiazepine prescription fills. “Fills” refer to the number of prescriptions being picked up by patients, rather than the number of prescriptions doctors write. This is based on calculating the rate of individual patients who filled a prescription in a state, the average days of supply per prescription fill, and average prescription fills per patient.

Notably, we found that not all state policies led to similar changes in prescription fill patterns.

Why It Matters

In 2021, nearly 23% of the adult U.S. population reported having a diagnosable mental health disorder. Yet only 65.4% of those individuals reported receiving treatment within the past year. This lack of treatment can exacerbate current mental health disorders, leading to increased risk for additional chronic conditions.

Marijuana access introduces an alternative treatment to traditional prescription medication that may provide easier access for some patients. Many state medical laws allow patients with mental health disorders such as post-traumatic stress disorder, or PTSD, to use medical cannabis, while recreational laws expand access to all adults.

Our findings have important implications for insurance systems, prescribers, policymakers and patients. Benzodiazepine use, like opioid use, can be dangerous for patients, especially when the two classes of drugs are used together. Given the high level of opioid poisonings that also involve benzodiazepines – in 2020, they made up 14% of total opioid overdose deaths – our findings offer insights into potential substitution with marijuana for medications where misuse is plausible.

What Still Isn’t Known

Our research does not clarify whether the changes in dispensing patterns led to measurable changes in patient outcomes.

There is some evidence that marijuana acts as an effective anxiety treatment. If this is the case, moving away from benzodiazepine use – which is associated with significant negative side effects – toward marijuana use may improve patient outcomes.

This finding is critical given that about 5% of the U.S. population is prescribed benzodiazepines. Substituting marijuana has the potential to result in fewer negative side effects nationwide, but it’s not yet clear if marijuana will be equally effective at treating anxiety.

Our study also found evidence of a slight – albeit somewhat less significant – increase in antipsychotic and antidepressant dispensing. But it’s not clear yet whether marijuana access, particularly recreational access, increases rates of psychotic disorders and depression.

While we found that, overall, marijuana access led to increased antidepressant and antipsychotic fills, some individual states saw decreases.

There is a lot of variation in the details of state marijuana laws, and it’s possible that some of those details are leading to these meaningful differences in outcomes. I believe this difference in outcomes from state to state is an important finding for policymakers who may want to tailor their laws toward specific goals.

Ashley Bradford, PhD, is an Assistant Professor of Public Policy at the Georgia Institute of Technology. Her research focuses on how public policies shape health outcomes within the United States.

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

Medical Schools Do a Poor Job Teaching About Disability

By Crystal Lindell

Medical schools don’t teach their students well about disability, which can have negative effects for both disabled patients and disabled medical students, according to a new study published in the Journal of General Internal Medicine.

Researchers found that medical school curriculum often treats disability as a problem, leading students to make negative assumptions about the health and quality of life of people with disabilities. That makes them ill-prepared for treating disabled patients.

The overall attitude also results in fewer disabled people becoming doctors.

“Doctors do not know how to care for people with disabilities because they never learned,” lead author Carol Haywood, PhD, assistant professor at Northwestern University’s Feinberg School of Medicine, said in a press release.

“Ultimately, our work reveals how medical education may be playing a critical role in creating and perpetuating ideas that people with disabilities are uncommon and unworthy in health care.”

Haywood and her colleagues hosted virtual focus groups for both medical school faculty and students. They found four recurring themes in the discussions:

1. Disability is often neglected in medical education 

Participants said disability was only mentioned in select lectures and elective coursework, largely relegating the training to students and faculty who are already familiar with or have a personal interest in disability. 

One faculty participant said: “The fact that [disability training] is not required, and it’s not seen as a core part of the medical school curriculum … reinforces the idea that these aren’t really your patients or they’re not important enough for you to learn about.”

2. Disability is often framed as a “problem” in medical school 

Most medical schools define disability as a condition where an individual is simply diagnosed and treated, rather than something rooted in physical barriers, social bias and stigmatization. 

One student said: “Just seeing how biases can be sort of continued on through generations of doctors … whether that means that thinking of disability as a tragedy or … a medical condition.”

3. Negative ideas about disability limit diversity in medicine 

Participants described a neglect of disability training as being part of a “hidden curriculum” in medical education that teaches students that disability does not belong in society. Students with disabilities are often viewed as weak or incapable of excelling in medical practice. 

One participant said: “We're just sending the message from the get-go that you’re not welcome, which is so damaging in every possible way.”

4. There’s an over-reliance on faculty and student-led efforts to cultivate change 

When their training fell short, faculty and students sought mentorship and communities to discuss and understand disability-related healthcare. 

One student said: “It’s hard to be mad at physicians …. Because they weren’t taught how to do it or taught to ask the questions, or it wasn’t emphasized.”

Insufficient support from institutional and licensing authorities has also stymied efforts to improve disability training. Disability is often not included in studies focused on mitigating healthcare disparity — despite well-known vulnerabilities of people with disabilities.

“While we have known about physician bias and discrimination against people with disabilities in health care for some years now, this new work emphasizes the need for medical schools and regulating bodies… to take on the responsibility of educating future physicians about the care of people with disabilities,” said co-author Tara Lagu, MD, adjunct professor of medicine and medical social sciences at Feinberg.

Improving disability-related medical education will require systemic reform, such as adding a “disability-competent” to medical education to make students more aware of abelism – a tendency to think that everyone has the same mental and physical abilities.

Other remedies include having disabled guest speakers share their experiences navigating the healthcare system; having physical therapists, occupational therapists and speech language pathologists discuss their treatment of people with disabilities; and having students participate in the care of disabled patients during patient rounds, physical exams, documentation, and clinical decision making.

Opioid Pain Medication Used Infrequently by NFL Players

By Pat Anson

As many football fans know, the odds of a National Football League player getting injured during a practice or game are high. A concussion, Achilles rupture, ligament tear or musculoskeletal injury can cause a player to miss a game or even an entire season.

Given the pressure to compete and be ready to play, perhaps it’s not surprising then that nearly 70% of NFL players were prescribed a pain medication during the 2021-2022 seasons.

What is surprising is the type of analgesics they were using.

A new study found that only 2.9% of the pain medications used by NFL players were opioids. The vast majority (86%) of medications, both prescribed and over-the-counter, were nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac. Other non-opioids used by players were muscle relaxants, corticosteroids, gabapentin, acetaminophen and migraine medication.  

The study, recently published in Current Sports Medicine Reports, is based on data from a prescription drug monitoring program (PDMP) that was launched by the NFL in 2019 for all players.

“NFL athletes are exposed to very physical contact and to the development of pain during or after games due to injuries. There’s always been a concern from a safety and health perspective about what are they using to treat their pain,” said co-author Kurt Kroenke, MD, a researcher-clinician at the Regenstrief Institute and Indiana University School of Medicine.

“The good news is of all medicines prescribed to league players for pain, opioids account for only 3 percent. Moreover, only 10 percent of NFL athletes received even a single prescription for an opioid during a one-year period. I think there's been much greater attention to what can be done in the training room for NFL athletes for their injuries and pain that doesn't rely on medicines.”

The findings are remarkable, given the long history of opioid use in the NFL. A 2010 survey of retired players found that over half (52%) used prescription opioids during their careers, with 71% of them reporting misuse. Many continued to use opioids after they stopped playing, with 81% of the retired players reporting their chronic pain was moderate to severe.

Hall of Fame quarterback Brett Farve, an iron man who often played through injuries, admitted taking 15 hydrocodone (Vicodin) pills at a time, and even resorted to asking teammates for their pills.

The NFL’s laissez-faire attitude about opioids started to change after 1,800 former players sued the league in 2016, alleging that team doctors routinely disregarded DEA rules about controlled substances and encouraged players to use opioids and anti-inflammatory drugs.  It was not uncommon at the time for a player to get 6-7 pain pills or injections per week.

Injuries are still common in the NFL, but the league watches drug use much more closely. Every NFL player is tested for drugs at least once a year, usually before the season starts. The league also relaxed its policy about marijuana, effectively allowing players to consume cannabis during the off-season. Moderate consumption is tolerated during the season, as long as a player doesn’t have high levels of THC.   

“Professional football is a very physical sport. But anyone who watches professional hockey or NBA basketball or big league soccer and even college and high school sports, realizes how these players also are prone to injuries and pain,” said Kroenke. “I think how we treat pain safely, using opioid pain medications very infrequently, applies across all sports.”

Stem Cell Marketers Ordered to Pay $5 Million for Misleading Health Claims

By Crystal Lindell

The co-founders of the Stem Cell Institute of America (SCIA) misled seniors and the disabled about the benefits of stem cell therapy, according to a recent federal court ruling that orders them to pay $5.1 million in civil penalties and refunds to consumers. A separate order permanently bans them from future marketing and advertisements.

In 2021, the Federal Trade Commission and the Georgia Attorney General sued SCIA co-founders Steven Peyroux and Brent Detelich for promoting stem cell treatments through deceptive marketing schemes with chiropractors and healthcare providers. 

The promotions claimed that stem cell injections were superior to surgery, steroids and pain medication in treating arthritis, joint pain and other orthopedic conditions. The injections cost as much as $5,000 per joint, with patients often getting multiple injections.

The FTC says the marketing was aimed almost exclusively at elderly and disabled people.

“The founders of the Stem Cell Institute of America and their network of companies tricked people who needed real medical help into buying expensive, unproven stem cell therapy,” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said in a press release.

“The court’s orders hold them accountable, refund consumers, and permanently ban the defendants from offering stem cell therapy and other regenerative medicine treatment in the future.”

SCIA ADVERTISEMENT

In 2015, Peyroux, a chiropractor, and Detelich, a former chiropractor, founded SCIA, a company that trained chiropractors and other healthcare practitioners how to recruit patients through advertising and “educational seminars.” SCIA also provided them with a “vault” of sample advertisements rife with baseless claims of efficacy, and the appearance of being part of a nationwide SCIA network.

The defendants also used deceptive marketing materials and seminars to attract stem cell patients to their own chiropractic clinic. 

‘FDA’s War on Public Health’

Coincidentally, news of the court order comes just days before President-elect Donald Trump is sworn in for a second term. 

During his first term, Trump was a strong supporter of “Right to Try” legislation that gave terminally ill patients the right to try stem cells and other experimental treatments that were not yet approved by the government.

The FDA under President Trump also gave the stem cell industry three years to show whether regenerative medicine treatments were safe and effective before regulators started cracking down on them. The move effectively gave stem cell providers a huge break, allowing hundreds of new clinics to open up and offer stem cell treatments with little oversight.

The 3-year grace period was then extended six months due to COVID, which had the effect of giving the clinics free range for most of Trump’s first term. 

Robert F. Kennedy, Jr., Trump’s nominee to head the Health and Human Services Department, has also pledged to loosen the FDA’s tight control over stem cells and other innovative treatments.

“FDA’s war on public health is about to end,” Kennedy wrote in an October 25 tweet. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can't be patented by Pharma.” 

In a November interview with NPR, RFK Jr. said Trump had given him instructions to stop the “corruption and the conflicts” at federal health agencies and to end the “chronic disease epidemic” with measurable progress within two years.

Exclusive: How CDC Will Evaluate the Impact of Its Opioid Guidelines

By Pat Anson

We’ve learned more about a research study the CDC plans to conduct on the impact of its opioid prescribing guideline, which took opioids off the table as a treatment option for millions of Americans suffering from chronic or acute pain. The study was briefly outlined in a public notice published in the Federal Register in October.

It’s been over 8 years since the CDC released its controversial guideline and two years since the agency revised it, after receiving many reports of patient harm, including rapid opioid tapering, withdrawal, poorly treated pain, and suicide.

The agency has released few details on the “mixed-method quasi-experimental design” of the study, the first attempt by the agency to get direct feedback from patients, caregivers and doctors about the guideline’s impact on pain management.

Further details of the study are not coming from the CDC, but from the Office of Management and Budget (OMB), which is evaluating whether the study meets the requirements of the Paperwork Reduction Act, a law that gives OMB broad authority over the collection of data by federal agencies. The CDC’s briefings for the OMB can be found here, here and here.        

“The goal of this research study is to conduct a rigorous, comprehensive evaluation to assess the 2022 CDC Clinical Practice Guideline implementation, uptake, and outcomes. The government will use this information collection to inform CDC efforts and interventions to ensure that Americans have access to safer, effective ways of managing their pain,” the CDC explained.

“We propose conducting an analysis of changes in public and private payers’ policies—e.g., those governing Medicaid, Medicare, private health plans—since late 2022 when the CDC released the Clinical Practice Guideline.”

The study will be conducted over a four-year period and cost nearly $4 million, with much of the work subcontracted to Abt Global, a private research and consulting firm. Abt Global will perform a series of interviews, surveys and focus groups involving patients, caregivers and doctors; as well as dentists, insurers, health system leaders, professional medical associations, and state medical boards.

The DEA and other law enforcement agencies that investigated and prosecuted doctors for “unlawful” opioid prescribing are not included in the study.

The CDC’s previous attempts at evaluating the 2016 and 2022 guidelines relied on data about opioid prescribing rates, not on patient welfare or even whether the guidelines met their primary goal of reducing opioid addiction and overdoses. In that respect, the guidelines have failed. While opioid prescribing has fallen to levels not seen in decades, opioid-related overdoses have nearly doubled since the 2016 guideline’s release.

‘What Has Been Most Effective in Managing Your Pain?’

The CDC is planning an online survey of about 600 doctors (with invitations sent to 3,000) and virtual interviews with 30 of them, asking about their pain management and opioid prescribing practices, as well as any “unintended consequences“ of the agency’s guidelines. Similar questions will be asked of the dentists, insurers, health systems, medical boards, and professional societies.

No interviews or surveys are planned with patients or caregivers. Instead, a series of one-hour focus groups will be conducted involving a total of 135 patients and 90 caregivers, who will receive a $75 gift card as an incentive to participate. The CDC says it will “partner with patient advocacy organizations” to identify participants from their membership lists.

Due to the nature of focus groups, the opinions gathered from patients and caregivers are likely to be viewed as anecdotal or qualitative “perceptions,” not quantitative research.

“We will conduct focus groups with patients to provide an in-depth understanding of a single or small number of cases set in their real-world contexts. Examining the experiences of patients can provide a deeper understanding of real-world behavior within a specific healthcare context to elucidate perceptions of whether and/or how changes occurred in overall treatment and/or pain management, including opioid prescribing,” the CDC said.

The focus groups will be led by Abt Global moderators, who will ask a series of open-ended questions to promote discussion. Notably, there are more questions in the “Patient Focus Group Guide” about non-opioid pain treatments than there are about opioids.

There are also no questions about the CDC’s 2016 guideline. The focus is only on pain management after November 2022, when the revised guideline was released in an attempt to give more flexibility to doctors in using opioids to manage pain.

Focus Group Questions for Patients  

1. What treatments and medications for pain have you tried? What has been most effective in managing your pain?

2. There are a lot of strategies to help with pain. Tell us about your experience with physical therapy or exercise therapy to help with your pain.

3. Counseling or behavioral therapy is often used to help with pain. What has your experience been receiving counseling for pain management?

4. Have you had experience with any other non-medication therapies for pain (e.g., acupuncture)? Can you share your experience with those?

5. Medications other than opioids, such as ibuprofen and acetaminophen, which can be both prescribed or over-the-counter, are also often used for pain management. Tell us your experience with these non-opioid medications to manage your pain.

6. Tell us about your first experience being prescribed opioids for pain. How was your pain after you began taking opioids? What side effects did you experience?

7. When were you initially prescribed opioids for pain? How long were you initially prescribed opioids for? Had you received additional refills for opioids after that first prescription?

8. Have you noticed any changes to how clinicians manage your pain since November 2022? If so, what have you noticed?

9. Give me an example of how the management of your pain has improved since November 2022?

10. Give me an example of how the management of your pain remained the same since November 2022?

11. How has your pain management gotten worse since November 2022?

12. Since November 2022, what other factors may have affected how your pain has been managed, such as a change in primary care clinician or changes in your insurance coverage or changing from a primary care clinician to a pain management specialist?

This kind of detail about the questions, participants and research methods has not been made public before. Only a brief overview of the study was provided in the October 2024 notice in the Federal Register, which the CDC made no effort to publicize to get broad public feedback.

As a result, the notice received only two public comments, one of them a letter from the American Society of Anesthesiologists (ASA). The ASA called the 2022 guideline a “significant improvement” over the 2016 guideline, but added that 40% of its members felt the updated guideline was “ineffective.” There were also criticisms that the guidelines “might lead to reduced access to necessary pain medications.”

The CDC was dismissive of both public comments and said no changes would be made to its study design or methodology.  

“The public comments received did not have specific suggestions that impact any evaluation instruments; therefore, no changes were made to the instruments,” CDC said.      

How Vaccine Misinformation Distorts Science

By Mark O'Brian

Vaccinations provide significant protection for the public against infectious diseases and substantially reduce health care costs. Therefore, it is noteworthy that President-elect Donald Trump wants Robert F. Kennedy Jr., a leading critic of childhood vaccination, to be secretary of Health and Human Services.

Doctors, scientists and public health researchers have expressed concerns that Kennedy would turn his views into policies that could undermine public health. As a case in point, news reports have highlighted how Kennedy’s lawyer, Aaron Siri, has in recent years petitioned the Food and Drug Administration to withdraw or suspend approval of numerous vaccines over alleged safety concerns.

I am a biochemist and molecular biologist studying the roles microbes play in health and disease. I also teach medical students and am interested in how the public understands science.

Here are some facts about vaccines that Kennedy and Siri get wrong:

Vaccines Don’t Cause Autism

Public health data from 1974 to the present conclude that vaccines have saved at least 154 million lives worldwide over the past 50 years. Vaccines are also continually monitored for safety in the U.S.

Nevertheless, the false claim that vaccines cause autism persists despite study after study of large populations throughout the world showing no causal link between them.

Claims about the dangers of vaccines often come from misrepresenting scientific research papers. In an interview with podcaster Joe Rogan, Kennedy incorrectly cited studies allegedly showing vaccines cause massive brain inflammation in laboratory monkeys, and that the hepatitis B vaccine increases autism rates in children by over 1,000-fold compared with unvaccinated kids. Those studies make no such claims.

In the same interview, Kennedy also made the unusual claim that a 2002 vaccine study included a control group of children 6 months of age and younger who were fed mercury-contaminated tuna sandwiches. No sandwiches are mentioned in that study.

Similarly, Siri filed a petition in 2022 to withdraw approval of a polio vaccine based on alleged safety concerns. The vaccine in question is made from an inactivated form of the polio virus, which is safer than the previously used live attenuated vaccine.

The inactivated vaccine is made from polio virus cultured in the Vero cell line, a type of cell that researchers have been safely using for various medical applications since 1962. While the petition uses provocative language comparing this cell line to cancer cells, it does not claim that it causes cancer.

Vaccines Undergo Clinical Trials

Clinical trials for vaccines and other drugs are blinded, randomized and placebo-controlled studies. For a vaccine trial, this means that participants are randomly divided into one group that receives the vaccine and a second group that receives a placebo saline solution. The researchers carrying out the study, and sometimes the participants themselves, do not know who has received the vaccine or the placebo until the study has finished. This eliminates bias.

Results are published in the public domain. For example, vaccine trial data for COVID-19, human papilloma virus, rotavirus and hepatitis B are available for anyone to access.

Aluminum Boosts Immunity

Kennedy is co-counsel with a law firm that is suing the pharmaceutical company Merck based in part on the unfounded assertion that the aluminum in one of its vaccines causes neurological disease. Aluminum is added to many vaccines as an adjuvant to strengthen the body’s immune response to the vaccine, thereby enhancing the body’s defense against the targeted microbe.

The law firm’s claim is based on a 2020 report showing that brain tissue from some patients with Alzheimer’s disease, autism and multiple sclerosis have elevated levels of aluminum. The authors of that study do not assert that vaccines are the source of the aluminum, and vaccines are unlikely to be the culprit.

Notably, the brain samples analyzed in that study were from 47- to 105-year-old patients. Most people are exposed to aluminum primarily through their diets, and aluminum is eliminated from the body within days. Therefore, aluminum exposure from childhood vaccines is not expected to persist in those patients.

Ironically, Kennedy’s lawyer, Siri, wants the FDA to withdraw some vaccines for containing less aluminum than stated by the manufacturer.

Vaccine Manufacturers Can Be Held Liable

Kennedy’s lawsuit against Merck contradicts his insistence that vaccine manufacturers are fully immune from litigation.

His claim is based on an incorrect interpretation of the National Vaccine Injury Compensation Program, or VICP. The VICP is a no-fault federal program created to reduce frivolous lawsuits against vaccine manufacturers, which threaten to cause vaccine shortages and a resurgence of vaccine-preventable disease.

A person claiming injury from a vaccine can petition the U.S. Court of Federal Claims through the VICP for monetary compensation. If the VICP petition is denied, the claimant can then sue the vaccine manufacturer.

The majority of cases resolved under the VICP end in a negotiated settlement between parties without establishing that a vaccine was the cause of the claimed injury. Kennedy and his law firm have incorrectly used the payouts under the VICP to assert that vaccines are unsafe.

The VICP gets the vaccine manufacturer off the hook only if it has complied with all requirements of the Federal Food, Drug and Cosmetic Act and exercised due care. It does not protect the vaccine maker from claims of fraud or withholding information regarding the safety or efficacy of the vaccine during its development or after approval.

Good Nutrition Is Not a Substitute for Vaccination

Kennedy asserts that populations with adequate nutrition do not need vaccines to avoid infectious diseases. While it is clear that improvements in nutrition, sanitation, water treatment, food safety and public health measures have played important roles in reducing deaths and severe complications from infectious diseases, these factors do not eliminate the need for vaccines.

After World War II, the U.S. was a wealthy nation with substantial health-related infrastructure. Yet, Americans reported an average of 1 million cases per year of now-preventable infectious diseases.

Vaccines introduced or expanded in the 1950s and 1960s against diseases like diphtheria, pertussis, tetanus, measles, polio, mumps, rubella and Haemophilus influenza B have resulted in the near or complete eradication of those diseases.

It’s easy to forget why many infectious diseases are rarely encountered today: The success of vaccines does not always tell its own story. RFK Jr.’s potential ascent to the role of secretary of Health and Human Services will offer up ample opportunities to retell this story and counter misinformation.

Mark R. O'Brian, PhD, is a Professor and Chair of Biochemistry at the University at Buffalo. His research is focused on understanding how microbes regulate cellular processes relevant to agriculture, human health and disease.

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

FDA Approved Genetic Test for Opioid Use Disorder Is Flawed

By Crystal Lindell

An FDA-approved test that claims it can identify genetic risk for opioid use disorder (OUD) is so flawed as to basically be useless – at least according to a new study published in JAMA.

The genetic test, which is sold under the brand name “AvertD” by AutoGenomics, was given approval by the Food and Drug Administration in 2023. The test claims it can use 15 genetic variants to identify people at risk for misusing opioids. 

According to AutoGenomics, the variants “may be associated with an elevated genetic risk for developing OUD.” However, the company provides no citations to support the associations between the brain reward pathways and OUD — meaning the test’s foundation itself seems to be flawed.

However, the authors took the premise of the AvertD test seriously, and set out to find if it could actually predict OUD. They looked at a diverse sample of more than 450,000 “opioid-exposed individuals” (including 33,669 individuals with OUD), and found no evidence to support the use of the AvertD test. 

Specifically, they found both high rates of false positives and false negatives, with 47 out of 100 predicated cases or controls being incorrect. 

“Notably, clinicians could better predict OUD risk using an individual’s age and sex than the 15 genetic variants,” researchers said.

The fact that the test doesn’t seem to work could have dangerous consequences for pain patients. The fear is that they will be used to deny patients opioid medications simply because their “genetic markers” show them to be in a high-risk patient group. 

The study authors directly point this out, writing: “False-positive findings can contribute to stigma, cause patients undue concern, and bias health care decisions.”

They also point out the potential harms of a false-negative finding, which "could give patients and prescribers a false sense of security regarding opioid use and lead to inadequate treatment plans."

The fact that this genetic test has gotten as far as it has raises questions about the FDA approval process. 

The problems don’t stop there though. Another major flaw in both the study and the genetic testing is that “Opioid Use Disorder” has such murky diagnostic criteria, that it’s difficult to take it seriously. It’s basically a set of vague symptoms, as opposed to a clear-cut diagnosis, despite what some have been led to believe. 

A CDC fact sheet for OUD Diagnostic Criteria is a mishmash of vague symptoms, such as tolerance and withdrawal, that could just be the result of untreated or poorly treated physical pain. 

Things like “taking opioids in larger amounts or over a longer period of time than intended” and “having a persistent desire or unsuccessful attempts to reduce or control opioid use.”

The CDC also lists "withdrawal symptoms" as one of the diagnostic criteria for OUD, which is something that people can experience from rapid tapering without having OUD.

The CDC then includes the odd disclaimer that “tolerance and withdrawal are not considered” when opioids are taken under appropriate medical supervision.

So in a country that does not guarantee healthcare, you can avoid an OUD diagnosis if you can afford to find a doctor willing to prescribe opioids to you. But if you can’t find a doctor or abandoned by one — and then have withdrawal symptoms — you must have a disorder.

That doesn’t sound like a medical diagnosis to me. That sounds like classism.

A patient needs just to have just two of the OUD criteria to have “mild OUD” – a benchmark that has the sweeping effect of including a large number of patients taking opioids for chronic pain. 

It’s no wonder that a genetic test claiming to be able to predict OUD would be so flawed, given how flawed the diagnosis of OUD is to begin with. 

Perhaps instead of trying to guess potential risks for a vague disorder, the FDA should be focused on treatments already proven effective for people who want to stop their opioid use, like expanding methadone access. 

The whole situation reminds me of the Tom Cruise-movie Minority Report, a futuristic thriller in which a specialized police department called Precrime “apprehends criminals by use of foreknowledge provided by three psychics.”

Denying people pain medication based on a flawed genetic test that falsely claims it can predict the future is basically the same thing. And it’s just as evil in real life as it is in the movie.  

Got Colostrum? The Good and Bad About Bovine Milk Supplements

By Manal Mohammed

From Kourtney Kardashian Barker to Gwyneth Paltrow, wellness celebrities are extolling the benefits of taking bovine colostrum supplements. Social media influencer Sofia Richie Grainge has even launched her own bovine colostrum-laced smoothie.

The supplement, they claim, offers a wide range of health benefits, including glowing skin with increased elasticity. Some brands claim that consuming bovine colostrum can protect adult humans from cold, cough and sickness bugs, improve gut health and support weight loss.

Bovine colostrum is also popular among some athletes who claim it can help improve exercise performance, build strength and speed up recovery.

I’m no stranger to the benefits of animal colostrum – before I joined academia I worked as a veterinarian. I witnessed that newborn animals who did not receive colostrum just after birth were at a significantly increased risk of death and disease. I was emphatic to my clients, then, about the crucial role of colostrum in the early development of newborn animals, as well as their overall health later in life.

But is cow colostrum a miracle health elixir or just the latest wellness fad?

Nature’s First Vaccine

There’s no doubt that colostrum is wonderful stuff. Known as “nature’s first vaccine”, colostrum is the first milk produced by the breast of female mammals in the two to five days immediately after giving birth. It is a nutrient dense liquid rich in antibodies, antioxidants, growth factors, vitamins, minerals and nutrients that boost newborns’ immune systems and support their overall growth.

In humans, colostrum should be given to newborns as soon after birth as possible, preferably within the first hour of birth and repeated at no later than six hours after birth. Colostrum is perfectly balanced for all baby’s needs. But there is not enough rigorous scientific evidence on human colostrum’s benefits for adults.

There is, though, some evidence to suggest that bovine colostrum may help humans to fight infection, improve gut health, relieve stomach and digestive issues, reduce inflammation and lower risk of catching the flu and upper respiratory infections.

But its efficacy depends on the product: how it’s processed, manufactured and stored – and the product’s potency. Bovine colostrum supplements aren’t regulated in the same way as drugs so there’s currently no guarantee of consistent quality.

Bovine colostrum contains higher total protein content than mature milk, mainly due to higher levels of antibodies (also known as immunoglobulins) and casein – a protein that supports muscle building. As well as immune-regulatory, antibacterial and anti-inflammatory properties, milk casein may offer a number of metabolic and protective benefits for humans.

For example, it can help to reduce appetite because it’s digested more slowly than other proteins. Research suggests that consuming casein before bed may increase metabolic rate and the protein has also been associated with improvement in brain function because of its protective effects on the nervous system.

The level of antibodies in bovine colostrum can be 100 times higher than levels in regular cow’s milk. Hyperimmune bovine colostrum is made by cows that have been vaccinated for diseases such as rotavirus. These cows produce antibodies that can help fight viruses and bacteria that cause disease and infection.

And that’s not all. Bovine colostrum also contains antimicrobials, which kill bacteria, viruses, fungi and parasites. Studies have also shown that these antimicrobials can help prevent common gastrointestinal infections, such as Escherichia coli, Salmonella and Helicobacter pylori. They can also act as prebiotics by stimulating growth of beneficial bacteria in the gut.

As if that isn’t enough, studies also report that taking blood colostrum supplements may help reduce flu-like episodes and upper respiratory tract infections. A 2006 study even suggested that taking bovine colostrum might help reduce diarrhoea in people with HIV/AIDS.

Miracle Milk or Frivolous Fad?

Taking bovine colostrum might sound appealing – but if you’re thinking of buying one of the expensive products on the market, bear in mind the lack of regulation and the scarcity of rigorous data on the safety and risks of the supplements.

What we do know is that people with a cow’s milk allergy should not ingest or apply bovine colostrum. Any use of bovine colostrum could result in severe side effects. In 2019 a 16-year-old boy with an allergy to cow’s milk developed anaphylaxis after a bovine colostrum-based cream was applied to a surgical wound. Even those who aren’t allergic to cow’s milk could suffer mild gastrointestinal discomfort, such as nausea and gas, while taking a bovine colostrum supplement.

So, it’s possible that bovine colostrum might offer some health benefits but the lack of product regulation and research makes buying supplements an expensive gamble. Having a healthy lifestyle with a good diet and regular exercise would undoubtedly be a much safer bet for your health – and your bank balance.

Manal Mohammed, PhD, is a Senior Lecturer of Medical Microbiology at the University of Westminster. Her research and teaching focus on infectious diseases, their diagnosis, prevention and treatment.

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