Iran War Creates ‘Perfect Storm’ for Drug Shortages 

By Pat Anson

The Iran war has disrupted the global supply chain so much that it could worsen shortages and raise prices of painkillers and other commonly used medications, according to experts. 

In addition to supplying much of the world with oil and natural gas, the Middle East serves as a crucial transportation hub for pharmaceutical companies. Ships and planes are being rerouted to avoid the region, which creates delays and higher shipping costs. 

“If the instability really persists, you’ll probably see lead times, transportation costs that can impact direct items that we need for our medicines, including the key starting materials into active pharmaceutical ingredients,” Gerren McHam, vice president of external affairs at the API Innovation Center, told The Hill.  

Even before the war, the UK was dealing with shortages of aspirin and co-codomal, a combination of paracetamol and codeine. Other drugs in short supply include those used to treat arthritis, diabetes, epilepsy and cancer.

The UK is reportedly “a few weeks away” from running out of some generic medicines. Like the United States, the UK relies heavily on generic pharmaceuticals produced in India.

“It’s the perfect storm. We have the conflict in the Gulf that caused the strait of Hormuz to shut down, and India is known as the pharmacy of the world. They produce a lot of the generic drugs and APIs (active pharmaceutical ingredients). With the geopolitical situation, it’s harder and harder to get those out,” said David Weeks, director of supply chain risk management at Moody’s. 

Before the war, Canada was also dealing with shortages of drugs used to treat pain and arthritis, according to a new report from the Canadian Arthritis Patient Alliance (CAPA). 

CAPA interviewed arthritis sufferers and their caregivers, who reported “profound disruptions to their physical and mental well-being” due to shortages of pain relievers such as Percocet, hydromorphone, Tylenol 3 and acetaminophen, as well as anti-inflammatory drugs and biologics used to treat arthritis. 

Patients and caregivers said they often had to make multiple trips to pharmacies before finding one that had their medications in stock.

“What happens to people who don’t have someone to support them through this? Would they just be waiting in the pharmacy while in immense pain - I would hate for my mom to be stuck in a situation like this on her own,” one caregiver told CAPA.

One bright spot is that shortages of oxycodone and acetaminophen with codeine that began last summer in Canada have largely ended. The drugs are now “generally available in pharmacies,” according to Health Canada.

The Iran war so far has had little immediate impact on pain patients in the U.S. – who have already been dealing with persistent shortages of opioid medication for several years. 

The American Society of Health-System Pharmacists (ASHP) continues to report shortages of oxycodone-acetaminophen tablets, oxycodone immediate release tablets, hydrocodone-acetaminophen tablets and morphine immediate release tablets; as well as injectable opioids used in surgery and emergency medicine. 

A new study published in JAMA Health Forum highlights how vulnerable the U.S. pharmaceutical industry is to global supply chain disruptions. 

Researchers at Yale University looked at stimulant shortages in 2022 and 2023, when many  patients with attention-deficit/hyperactivity disorder (ADHD) had difficulty filling their prescriptions. 

Although the limited supply was often blamed on increased demand and tight DEA production quotas, researchers say the more likely cause was a “historically unprecedented” decrease in US imports of amphetamine and other chemicals used to make stimulants. The shortfall in imports led to sudden production cutbacks by several stimulant manufacturers.

“Supply chain disruptions can occur in many places in the supply chain. However, descriptive evidence indicates that the most recent ADHD drug shortage may be associated with a disruption in the sourcing of raw ingredients from abroad,” researchers reported..

“More broadly, this economic evaluation reframes the discussion of ADHD medication shortages beyond DEA quotas, highlighting the vulnerability of US pharmaceutical manufacturing to international supply chain disruptions.” 

Pain Patients Ridicule FDA Plans for Opioid Disposal Systems

By Pat Anson

Should the FDA require pharmacies to provide in-home opioid disposal systems to patients, so they can safely dispose of their unused pain medication?

That’s the question being asked by the FDA in the Federal Register as it seeks public comment on the agency’s latest effort to combat opioid abuse. Although opioid prescriptions have already been reduced significantly – by 50% or more since 2011 – the FDA claims many pain patients still have excess opioids that can easily fall into the wrong hands.

“Having unused opioids laying around at home can be a significant risk to those struggling with opioids and can be a gateway for opioid-naïve family members,” said FDA Commissioner Marty Makary, MD. “We need to develop creative ways to address opioid misuse and abuse.”

Do patients really have opioids “laying around at home” that they don’t need? Given how far opioid prescriptions have fallen and how difficult they are to obtain, some find the idea laughable.

“Ridiculous, waste of money. I'm pretty sure there aren't any leftover pain medications that need disposal because they're not being prescribed to people who truly need them. This is like one of the most ridiculous wastes of money I have ever seen,” wrote April Stetka in her comment on the FDA proposal.

“I live with chronic pain. I am scrambling all the time to get enough medication to alleviate my pain,” said Isaac Arnett Jr. “The idea that people getting prescribed opioids for pain have extras sitting around is laughable.”

“This new proposed regulation is asinine, inhumane, morally corrupt, and continues to push a narrative full of xenophobia and stigma against people who require opioid analgesics. No one in their right mind would throw away life saving medications that are impossible to acquire in proper pain treating doses, if at all,” said Rodney Hipsher

“What are you going to do? Are you going to go into everyone’s house and go through their cabinets, looking for opioids?” asked Catherine Harris. “This is just one more step in treating surgical and chronic pain patients as toddlers, unable to monitor their own use and their own opioids. You have absolutely no right. This whole practice has been barbaric and the federal government and everybody involved should be ashamed at how far these policies have gone.” 

The FDA already requires pharmacies to provide prepaid envelopes to patients to mail back their unwanted opioids. Many pharmacies also have kiosks where unneeded medication can be dropped off, and the DEA regularly has drug “take back” days in local communities. As a last resort, the FDA even recommends flushing some excess opioids down the toilet.

Despite these efforts, the FDA claims that opioid analgesics remain the most common class of prescription drug that is misused, with about 8 million people reporting past-year misuse.

The term “misuse” is misleading, however, because it includes anyone not rigidly following their doctor’s orders. That can include someone taking less medication than what’s prescribed, or someone who stops taking a drug because it doesn’t work, has unwelcome side effects, or simply because they don’t need it anymore. 

Opioids are so difficult to obtain for some patients that they’ve resorted to hoarding excess pills because they’re uncertain if or when they’ll be able to get them in the future. In a PNN survey, nearly a third (32%) of pain patients admitted hoarding opioid medication — patients unlikely to need or want an in-home disposal system.

The odds of any excess opioids falling into the wrong hands are also low. According to the DEA, the estimated diversion rates for hydrocodone (0.53%) and oxycodone (0.69%) are both well under one percent.

Do Disposal Systems Work?

The FDA is vague about how opioid disposal systems should work, only that they be able to “inactivate, sequester, and/or absorb the opioid analgesic” so that it can be safely disposed in household trash.

At least nine commercial drug disposal systems already exist, but because the systems are not regulated and there are no industry standards to follow, there is limited information on their effectiveness or safety. The FDA says there have been reports to poison control centers of children accidentally being exposed to the disposal systems and of patients misunderstanding what the systems are for and ingesting their contents. 

The agency provides no estimate of a possible cost of in-home disposal systems or who should pay for it. But even if they were purchased by opioid manufacturers or pharmacies, you can bet those costs would eventually trickle down to insurers and/or patients. 

An in-home disposal system that is relatively inexpensive is DisposeRx. For $28.99, patients can get a lockable storage kit and packets containing a chemical powder that, when mixed with water, will bind to a medication and make it unusable.

A woman with two teenagers who cares for her elderly sick parents spoke highly of DisposeRx. She worries about her teens having access to her parents’ medications, and tries to get rid of them as soon as possible.

“I would save up my parents’ old meds on the counter until I had time to take them into a kiosk. There have been times where the kiosk is full or out of service and then I have to take everything back home where it goes on the counter again. This actually increases risk,” wrote Lara Popovich. “Now, as soon as I have an Rx my parents no longer need, I use DisposeRx powder and get rid of it immediately.”

People interested in leaving their own comments in the Federal Register have until April 6. You can learn more about the FDA proposal and submit a comment by clicking here.

U.S. Overdose Deaths Down Significantly

By Pat Anson

The number of fatal drug overdoses fell sharply in the U.S. in 2024, led by a significant decline in deaths involving illicit fentanyl, according to a new analysis.

Over 79,000 Americans lost their lives to a drug overdose in 2024, compared to 105,000 in 2023, a 24.5% decline in one year. Over 54,000 of the deaths in 2024 involved an opioid of some kind. 

The analysis by KFF further demonstrates the declining role of prescription opioids in the nation’s drug crisis. Prescribed opioids are now involved in about one in seven (13.6%) drug overdoses. 

In 2024, 10,851 Americans died from an overdose involving a natural or semi-synthethic prescription opioid, compared to 47,735 deaths involving synthetic opioids, mostly illicit fentanyl. 

Deaths from prescription opioids peaked at 17,029 in 2017 and have steadily declined.

U.S. Opioid Overdose Deaths 2004-2024

SOURCE: KFF

“Since the opioid epidemic was declared a public health emergency in 2017, it has claimed more than half a million lives. While the epidemic was initially driven by prescription opioids and heroin, it has evolved in recent years, to be dominated by illicit synthetic fentanyl — a substance significantly more potent than morphine,” KFF said. “Provisional CDC data suggest opioid deaths have continued to decline through 2025.”

The KFF analysis also looked at deaths involving alcohol, suicide and firearms.

In 2024, 48,824 American lives were lost to suicide, down slightly from the previous year. Firearms accounted for 57% of those deaths. There were 46,714 “alcohol-induced” deaths in 2024 caused by health conditions attributed to excessive alcohol use, about the same number of fentanyl overdoses.

Those deaths greatly outnumber fatal overdoses involving prescription opioids.

U.S. Deaths in 2024

Source: KFF

As PNN has reported, a recent study ranked alcohol as the 5th most harmful drug In the United States, behind illicit fentanyl, methamphetamine, crack and heroin. Prescription opioids ranked as the 7th most harmful drug in the U.S.

The analysis not only looked at the direct harm to drug users, but the indirect harm to families, communities and society at large caused by excessive drug use.

A panel of experts said the analysis shows how misdirected U.S. drug policy is, which is focused on crime and punitive measures to stop drug use, rather than public health measures to address substance use disorders. Criminalizing drug use may also be making the drug crisis worse, by taking legal drugs away from people who benefit from them.   

“All drugs have benefits to people who use them at least initially, and some may have ongoing benefits. For legal drugs, there may be social benefits like employment in related industries and taxation to fund public services,” wrote lead author Michael Broman, PhD, an Assistant Professor at The Ohio State University College of Social Work.

“Redirecting resources towards harm reduction may reduce social harms by reducing the economic cost of policing and surveilling people who use drugs. Concurrently, PWUD (people who use drugs) could remain contributing members of their families and communities.”

I Am Being Forced Off Oxycodone in the Name of Opioid Rotation

By Neen Monty

The current myth in opioid science is that buprenorphine is inherently safer than oxycodone.

The truth is far more ordinary: it depends on the individual. Some people do better on buprenorphine. Others do better on oxycodone. There is no universal “safer” opioid for every patient.

I have trialed buprenorphine before. It was profoundly sedating. I could not function on it.

Despite this, I was required to trial it again.

Here’s what happened.

Week One: Hope

The first few days were incredible.

Less pain.

More functional hours.

And I was sleeping until 5am!

I was thrilled to be wrong about buprenorphine. I ignored the severe nausea and the nagging headache because I could go back to the archery range. I started planning a fitness routine. I allowed myself to feel hopeful.

Week Two: Wearing Down

The nausea intensified. Even with ondansetron (Zofran), it was relentless.

The headache persisted. Not dark-room migraine territory, but just constant enough to make thinking difficult.

Panadol. Nurofen. Naproxen. Nothing touched it.

I also realised my mood had shifted. I felt low. Irritable. Short-tempered. Sad. Defeated.

I controlled it. I always do. I don’t take out my moods on others. My children didn’t see it. They saw normal. They did not see the enormous effort it took for me to stay calm and reasonable. 

The crying happened in the one private space I have: the bathroom. The sadness stayed hidden.

Week Three: Something Was Wrong

By week three, I was done.

My pain doctor told me to persevere. I did, as long as I could. At the end of week three, I ripped the buprenorphine patch off and did not apply the next one.

Enough was enough.

Within four days the nausea was gone.

The headache was gone.

I could think again. I could function again.

You never realise how severe something is until it stops.

Why did I tolerate it for so long? Because if I am labelled “non-compliant,” if I am judged not to be trying hard enough, I risk being forcibly tapered off all opioid medication.

And that would be catastrophic for me.

So, I tried.

Positive attitude! Yes, Doctor. I will trial it. With a smile on my face.

But I cannot continue with buprenorphine.

Next: Palexia

Now the rotation moves to another opioid: Palexia (tapentadol).

Doctors have been convinced that these newer opioids are “safer” than oxycodone. There is no high-quality evidence showing they are safer for stable, long-term chronic pain patients. But the safety narrative has been repeated so often, it is treated as fact.

Palexia is now the most commonly prescribed opioid in Australia. It has overtaken oxycodone. This did not happen because Palexia offers improved pain control. Or because it has fewer side effects. Or because it’s safer.

It happened because doctors were encouraged — in some cases pressured — to rotate patients off their “old school” opioids, to “atypical opioids” like Palexia, buprenorphine, and even tramadol.

A patient’s preference is no longer central. Being stable on a dose is no longer enough.

Opioid rotation is being enforced on me for two reasons.

First, because policies and guidelines position buprenorphine and tapentadol as the “safest” opioids. This is not evidence based; it is opinion.

Second, because I am not getting enough pain relief from my current regimen. My 20mg of oxycodone stops working after 6-8 hours, when it should last 12 hours.

The obvious solution is to prescribe it every 8 hours, instead of every 12 hours. That’s what happened in the past and was the standard of care. Because it is well recognised that the 12-hour formula rarely lasts 12 hours. 

But that would put me over the arbitrary daily dose ceiling of 100 MME. Which is also not evidence based. 

What is evidence based is that I was happier, healthier, fitter and more functional on 120 MME, rather than 100 MME.

But my well-being, pain control and function are not the important issues here.

Instead of the simple and obvious solution, the only solution is opioid rotation. The theory being that I have built up tolerance to oxycodone, but I have not built up tolerance to buprenorphine or tapentadol. So those medications will supposedly work better for me.

Except that’s not how it works in the real world.

Pain relief is not the goal here. It’s just not that important. It’s a money-making policy masquerading as “safety.”

Follow the money if you want to understand rapid prescribing shifts. Pharmaceutical policy rarely moves without financial incentive.

But here is the uncomfortable truth: My GP is not corrupt. She is not malicious. She is a very good GP. She is following guidelines.

She does not have time to audit every citation behind every recommendation on every guideline for every condition she treats. She has to trust her medical college, her training, and the documents placed in front of her.

That trust is not deserved. At least when it comes to treating chronic pain.

The current Australian guidelines are built on expert opinion, not randomised controlled trials. Opinion, layered over selective and cherry-picked evidence. Shaped heavily by academic pharmacology and population-level policy concerns. Not patient outcomes, preference, function or stability.

And patients like me pay the price.

A Four-Week Pause

I told my GP I cannot continue buprenorphine.

She immediately began discussing Palexia.

I asked for four weeks. Just four weeks to stabilise. I am only just beginning to feel like myself again. I am only just becoming functional again. I just lost four weeks of my life to the last rotation attempt. I don’t feel ready to tackle the next medication yet.

I need to take a breath. I need to get back to “normal.” Albeit my normal.

This rotation destabilised me. Made me far worse, not better. 

Also, it would make medical sense to start the next medication from a steady baseline, not during biochemical and emotional turbulence.

She agreed. Very readily. I didn’t have to argue my case. I very much appreciate that. She prescribed my usual regimen of oxycodone extended release and immediate release.

So, for four weeks, I remain on oxycodone. For four weeks, I will stabilise. And feel like myself again.

After that, the forced rotation begins again. I have trialed Palexia before, a few years ago. It did not go well. But still, I am being forced to trial it again.

Round and round.

None of this is my choice.

None of this is evidence based.

None of this is for my benefit.

The Systemic Problem

This is not just about me.

Patient choice has been steadily displaced by policy-driven prescribing. Stability is no longer considered sufficient. Long-term patients who are functioning are being told their medication is “unsafe.” Not because of their individual outcomes, but because of population-level risk narratives built on low-quality evidence and relative risk framing.

Meanwhile, newer opioids are positioned as “safer” without robust comparative long-term data in stable chronic pain populations. 

When prescribing patterns shift this dramatically and this quickly, it is reasonable to ask whether evidence alone is driving the change.

Medicine should be individualised. Instead, it is being standardised around risk optics, regulatory anxiety, and market forces.

And patients bear the instability.

Yes, some patients can safely be rotated, with no adverse events. But not all patients.

A large percentage are objectively and substantially worse off. But this does not matter. Patient satisfaction, patient function, pain relief are all secondary concerns. Often not considered at all. Or, if acknowledged, are dismissed as the patient being difficult or non-compliant.

Patients no longer have any agency, any choice, any control, or even a voice.

Neen Monty is a patient advocate in Australia who lives with rheumatoid arthritis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a progressive neurological disease that attacks the nerves.

Neen is dedicated to challenging misinformation and promoting access to safe, effective pain relief. For more information on chronic pain, the science, the politics and the lived experience, got to Pain Patient Advocacy Australia. You can also subscribe to Neen’s free newsletter on Substack, “Arthritic Chick on Chronic Pain.”

Bill Expands Pain Care Options and Lowers Cost for Medicare Patients

By Dr. Lynn Webster

Everyone who reads this publication understands chronic pain is often treated as a symptom. However, for tens of millions of Americans, it is a disease state. It reshapes the nervous system, erodes function, and can narrow life experiences to what hurts least.

It’s also becoming more common. Federal survey data show that roughly a quarter of U.S. adults report chronic pain, and a substantial subset report “high-impact” chronic pain severe enough to limit work or daily activities.

The public conversation about pain has been dominated for a decade by opioids, and for good reason. Opioids carry real risks, especially with long-term use, and the nation has paid dearly for indiscriminate prescribing and poor safeguards. But focusing only on opioids can obscure a quieter policy failure. Many patients who are trying to avoid opioids can’t reliably access effective non-opioid options, particularly in Medicare Part D.

That gap is structural, as well as clinical. Medicare Part D plans commonly use utilization management tools, prior authorization and step therapy among them, that can delay or block access to certain medications. For older adults living with neuropathic pain, fibromyalgia, or other chronic pain conditions, delays can mean months of impaired function while paperwork circulates, appeals are filed, and “fail-first” sequences play out.

In practice, these barriers can shape prescribing in ways that have little to do with what a clinician believes is best. When a newer non-opioid medication is placed on a high cost-sharing tier, requiring multiple authorizations, or is only covered after a patient “fails” other therapies, the path of least resistance too often becomes the therapy that is easiest to access — not necessarily the therapy that best matches the patient’s needs.

A bipartisan bill now before Congress is designed to address a narrow but consequential piece of that problem for Medicare beneficiaries: the Relief of Chronic Pain Act of 2025 (S. 3064). Its basic logic is simple: If policymakers want less reliance on opioids, coverage rules should not systematically disadvantage non-opioid alternatives.

The bill would do three things for qualifying non-opioid chronic pain management drugs in Part D plans, beginning in 2026. It would waive the deductible, require plans to place the drug on the lowest cost-sharing tier, and prohibit prior authorization and step therapy, which forces patients to try an opioid first.

Importantly, S. 3064 is not written as an open-ended mandate for all pain treatments. It defines qualifying drugs as FDA-approved non-opioid products for chronic pain conditions that do not act on opioid receptors and, in general, are not simply interchangeable with an existing therapeutically equivalent product.

It also defines “chronic pain condition” with specific examples, including diabetic peripheral neuropathic pain, endometriosis, fibromyalgia, musculoskeletal pain, neuropathic pain, post-herpetic neuralgia, and trigeminal neuralgia.

Why does a target change like this matter? Because pain is not just discomfort; it is an economic and social force. Chronic pain drives health care use, disability claims, and lost productivity on a massive scale, with major national cost estimates in the hundreds of billions of dollars annually.

When coverage delays effective treatment, the downstream costs do not disappear. They shift to more Medicare patients falling, more deconditioning, more depression and isolation, more emergency visits, and -- in some cases -- greater exposure to higher-risk medications.

Coverage policy won’t solve chronic pain by itself. The best care is multimodal: movement, behavioral strategies, physical and occupational therapy, interventional options when appropriate, and medications when they add meaningful benefit. Opioids will remain appropriate for a subset of people with chronic pain. But insurance design can either support alternative therapies or quietly undermine them.

S. 3064 asks Congress to make one pragmatic adjustment: Stop treating certain non-opioid options as luxuries for Medicare beneficiaries and start treating timely access as a basic component of safer pain care.

Unfortunately, since its introduction in Congress last October by Sen. Steve Daines (R-MT) and Sen. Maria Cantwell (D-WA), the bill has languished in the Senate Finance Committee. No hearings on S. 3064 are currently scheduled.

Readers who want to follow the proposal can review the bill text and legislative updates here. A public petition supporting the measure is also circulating for those who wish to add their names. If you want more options that are accessible and affordable, you should consider signing the petition and spreading the word. 

Lynn R. Webster, MD, is a pain and addiction medicine specialist. He writes and lectures on pain policy, patient safety and evidence-based treatment. Webster is currently a Senior Fellow for The Center for U.S. Policy. He is the author of the forthcoming book, “Deconstructing Toxic Narratives: Data, Disparities, and a New Path Forward in the Opioid Crisis.”

Tapering Plan Led by Pharmacists Shows No Benefit for Seniors

By Crystal Lindell

If pharmacists helped taper elderly patients off opioids and benzodiazepines, would that reduce their risk of falling?

Turns out, the answer is no. Having pharmacists get involved in a senior’s treatment plan doesn’t significantly reduce fall risk or prescriptions for the medications, according to research recently published in JAMA..

Falling is a significant risk factor for seniors, because their bones fracture more easily and it takes longer for them to recover. Medications that impair balance – such as opioids and anti-anxiety drugs – raise the risk of falling, especially in seniors who take them concurrently. 

Researchers at the University of North Carolina School of Medicine recruited 15 primary care clinics to participate in the study. Nearly 2,100 patients at the clinics met the study criteria, which was being over the age of 65 and having a long-term prescription for opioids and/or benzodiazepines. 

Over 95% of the patients on opioids had chronic pain and about a third of them had a fall in the past year..

Pharmacists for about half the patients were encouraged to “deprescribe” them, when appropriate, by recommending a voluntary taper plan to their doctors  The other patients received usual care from their doctors, without any tapering recommendations, and served as a control group.

A year later, doctors followed the pharmacists’ advice by tapering 21.4% of patients off of opioids. But that was only slightly more than the control group, which saw opioids discontinued for 19.9% of patients. The tapering rates for benzodiazepines were similar and “not statistically significant."

Notably, there was little difference in falls between the two groups, which were essentially “unchanged” by the tapering.

In other words, having a pharmacist make tapering recommendations to doctors had very little, if any, impact. Tapering occurred in both groups, whether a pharmacist was involved or not.

“Although reductions occurred in both groups, the intervention did not significantly reduce prescribing or falls at 1 year. Still, pharmacist recommendations were feasible to implement and accepted more often than rejected, indicating general practitioner receptiveness,” researchers concluded. “These results suggest that a consultant pharmacist–led intervention is feasible to implement in primary care clinics.”

Note the word, "feasible" rather than "effective." Sure, it can be done, but that doesn't mean it should be done.

I would guess that the program did not reduce prescriptions for opioids and benzodiazepines anymore than the control group because prescribing had already been reduced. At the start of the study, the average daily dose of opioids was 23.6 morphine milligram equivalents (MME), which is a low to moderate dose.

Given how much these medications are already being restricted, few patients are getting opioids or benzos if they don’t desperately need them – not even seniors.

Beyond that, I think it’s really important to take a step back when looking at research like this and consider the patient’s perspective. 

How were the tapering plans presented to patients? Were they asked to weigh the pros and cons? Did they have a voice in their treatment?  

I suspect if they were given the option of staying on a medication or reducing their fall risk, many seniors would choose to stay on the medication. 

Unfortunately, the study authors seem to take the wrong lesson from the research, at least in my opinion. Although their study failed to prove much of anything, they concluded there should be “more intensive or sustained deprescribing strategies.”

There are a lot of studies looking at ways to reduce opioid prescriptions — I suspect because those are the easiest to fund — and I’m honestly glad this one failed. 

The biggest problem many seniors face today is that they cannot get access to effective pain and anxiety treatment. If anything, researchers should be working to address that problem, rather than making it worse.

Instead of working on blanket reductions for these types of medications, I wish they would look at finding alternatives that actually work.

If you lost a loved to suicide after a change in their prescription pain medication, please consider participating in a survey to help researchers learn more about these tragic situations. Click here or on the banner below for more information.

Opioids Effective for Many Acute Pain Conditions

By Pat Anson

As pharmaceutical companies scramble to develop new non-opioid treatments for pain, a large new review found that opioid analgesics are effective for many acute pain conditions and come with little risk.

Led by researchers at the University of Sydney, the study looked at 59 clinical studies for dozens of short-term acute pain conditions.

They found “high-certainty” evidence that opioids were effective in treating abdominal pain, postpartum pain and dental pain; “moderate-certainty” evidence that they relieve pain from sciatica, post-operative pain and ten other acute conditions; and “low-certainty” evidence that they work on nine other short-term pain conditions.

There was no high quality evidence that opioids are ineffective for acute pain, but there was moderate and low quality evidence that they provide little relief for some acute conditions, such as pain from minimally invasive surgeries.

Adverse events were limited to vomiting and nausea, with no serious events like overdose, death, or addiction reported in any of the 59 studies.

“This paper is best understood as a broad evidence map, not a simple yes/no verdict on opioids for acute pain. It shows that opioids have helped in some acute pain conditions, but benefits are mixed, often modest, and vary by condition and timepoint,” said Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy, who was not involved in the study.

“The authors did not find a significant increase in serious adverse events in these short-term trials, but they also emphasize that harms reporting was incomplete.”

In short, opioids work for many acute pain conditions, depending on the dose, and pose no serious risk of harm, at least over the short-term.

“There was no high certainty evidence showing that opioids were not efficacious,” researchers reported in the journal Drugs. “There was no significant increased risk of serious adverse events in any review.”  

‘Opioids Aren’t Effective’ 

But that is not how the study was portrayed in a University of Sydney press release, which warned in a headline that “opioids aren’t effective for many acute pain conditions.”

The release quoted one author as saying opioids work “only slightly better than a placebo” and are not worth the risk.

“Our review found that they did not provide large or lasting pain relief compared with placebo for the vast majority of acute pain conditions, with pain relief typically lasting only a few hours,” said lead author Christina Abdel Shaheed, PhD, an Associate Professor in the School of Public Health at the University of Sydney. 

“By showing that the benefits are generally small, short-lived, absent for many common conditions, and sometimes harmful, our research challenges the widely held belief that opioids are the most effective ‘go-to’ option for acute pain.”

Shaheed and several of her co-authors have participated in other studies that take a dim view of opioids. One is a controversial 2023 trial, known as the OPAL study, which found that low doses of oxycodone work no better than a placebo in relieving acute back or neck pain. 

“Opioids should not be recommended for acute back and neck pain, full stop,” said Christine Lin, PhD. a Professor of Public Health at the University of Sydney, who was the lead investigator of the OPAL study and a co-author of the new study. 

Critics complained the OPAL study’s conclusions were too broad, not supported by evidence, and “misplaced and dangerous.”  In reply, Lin agreed that they may have gone too far and that their findings “might not be generalizable to all patients.”

Dr. Webster takes a similar view of the new study, saying it would be wrong to draw conclusions about the effectiveness or harm caused by opioids, given the low quality of most studies that were reviewed.

“The paper is best viewed as a map of evidence gaps and variable-quality evidence, not a final word,” Webster told PNN. “Most of the underlying reviews were rated critically low quality, so the paper is very useful for mapping what we know and what we still don’t know. Broad conclusions about opioid efficacy would be inappropriate.” 

One of the co-authors of the new study is Jane Ballantyne, MD, a former President and current Vice-President of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Ballantyne reported no conflicts of interest, although in the past she has acknowledged serving as a paid expert witness in opioid litigation cases.

Illicit Use of Rx Opioids Down Significantly 

By Pat Anson

The illicit use of prescription opioids by patients undergoing addiction treatment has fallen dramatically over the past decade, according to a new analysis by Millennium Health. 

The drug testing company analyzed nearly 1.7 million urine samples collected from patients diagnosed with substance use disorder (SUD). The findings show that opioid pain medication now plays only a minor role in the nation’s drug crisis, while the use of stimulants is growing.  

In 2016, up to 80% of the patients who tested positive for illicit fentanyl also tested positive for a prescription opioid that was not prescribed to them. 

By 2025, only 4.9% of patients tested positive for both fentanyl and an illicit prescription opioid. There was a lot of regional variability in the numbers, with 9.1% of SUD patients in the South testing positive for both fentanyl and Rx opioids, compared to only 4.1% in the West.

Positive Drug Tests for Fentanyl and Prescription Opioids

SOURCE: MILLENNIUM HEALTH

“Within the population using fentanyl, we've seen a continued drop in the detection of prescription opioids in those using fentanyl. In 2025 the positivity rate for prescription opioids, I’m talking about hydrocodone, hydromorphone, oxycodone, oxymorphone, tramadol as a group, are at all-time lows in our database,” said Eric Dawson, PharmD, Vice President of Clinical Affairs at Millennium Health.

The findings suggest that fewer prescription opioids are being diverted into the illicit drug supply. That makes sense, as opioid prescribing has fallen sharply over the past decade and the medications are difficult for many pain patients to get. According to the DEA, the estimated diversion rates for hydrocodone (0.53%) and oxycodone (0.69%) in 2026 are both well under one percent.

In their place, illicit drug users have increasingly turned to stimulants, such as methamphetamine and cocaine. Millennium’s data shows that while fentanyl and opioid use have declined in recent years, stimulant use has risen steadily.

Positive Drug Tests for Fentanyl, Opioids and Stimulants

SOURCE: MILLENNIUM HEALTH

“It makes us wonder if we're now moving to something more prominent, larger. I don't know the right word there, but a stimulant era,” Dawson told PNN.

“I continue to hear it everywhere I travel. Stimulants, methamphetamine and cocaine, are just incredibly plentiful in so many communities, and extremely inexpensive. And so, if you present a drug in front of a population that tends to use drugs and it's cheap or free and potent, they tend to gravitate toward that.” 

Another trend that appears in Millenium Health’s drug testing data is the growing detection of kratom and its alkaloids, mitragynine and 7-hydroxymitragynine (7-OH).

In 2016, less than 1.5% of patients nationwide being treated for SUD tested positive for a kratom alkaloid. By 2025, that had grown to about 3 percent, with even higher levels in the South.

Positive Drug Tests for Kratom

SOURCE: MILLENNIUM HEALTH

Part of that growth can be attributed to the wider availability of kratom and increased awareness that the herbal supplement can be used to treat pain, anxiety and other health conditions. 

The federal government estimates that 1.7 million Americans used kratom in 2021. The American Kratom Association, a kratom advocacy group, puts the number much higher, at 10 to16 million Americans.

The growing awareness about kratom has spread to addiction treatment providers. In 2016, only about a third of Millennium Health’s urine drug tests included a request from a provider to test for kratom. By 2025, over 77% of urine drug tests included an analysis for kratom.

How to Successfully Taper Off Medication – From Someone Who’s Actually Done It

By Crystal Lindell

The problem with tapering off a medication is that, before you even start, you first have to get past all the cultural messaging that tells you that going cold turkey is the morally superior method.

Often framed as a worthy struggle that “cleanses” the body of an addictive drug and the “sin” of needing it, cold turkey is frequently depicted as the narrative arc in movies and TV shows. Someone abruptly stops taking a drug, endures the immense suffering of withdrawal, and magically comes out the other side “fixed.”

That’s not real life though.

In my experience, slow tapering is the far superior way to successfully stop taking a medication long-term. I have found it works best for multiple types of drugs, ranging from opioids to antidepressants like Cymbalta, and even caffeine.

But “tapering” is a very broad term that can mean different things to different people. It’s something I myself had to figure out through years of personal trial and error.

So, here are three real-world tips for tapering off a medication that will actually work. Or at least they have for me and the people I know.

Just a quick reminder though, I am not a doctor. I am just a patient with lived experience. If you are able to talk to a doctor for help, you should do so.

1. Go Slower Than You Think You Need To

Tapering is a slow process. I have found it works best to drop your dose over a longer period of time than you first expect.

While it may be tempting to try to do it over the course of say, a week, you’re a lot more likely to stick with it if you taper slowly over something like 6-8 weeks.

I know, I know. It sounds like forever. But think of it as similar to weight loss. If you try to lose 20 pounds in the first week, you’re going to fail. It will be too overwhelming and you’ll end up quitting before you even lose that first pound. 

You’re a lot more likely to actually lose 20 pounds over 15-20 weeks, without rebounding by gaining the weight back.

The same is true with tapering off medication.

For example, if you are trying to go off 40 mg of hydrocodone, go down to 35 mg for at least 1-2 weeks or even longer. Then go down to 30 mg for at least another 1-2 weeks. And so forth and so on.

Trust me, it will be so much easier to stick with it, and so much easier on your body.

2. Taper Both Dose and Time

This was the biggest revelation for me, the first time I tapered off hydrocodone. You have to slowly taper down both the dose and the amount of time between those doses.

For example, if you are on three 10 mg pills a day, and you want to go down to two 10 mg pills, you should not taper down by taking them every 12 hours instead of 8.

Rather, it usually works better to take the reduced 20 mg of hydrocodone across three doses during the day, as that makes it much easier to tolerate.

Which brings me to a subsection of this tip: Consider cutting pills in half, or thirds, or whatever you need. A lot of pills will break in half using your hands, but if not, you can use a pill cutter or a knife. 

And if a pill can be cut in half, you can use that to come up with good doses as you taper.

Unfortunately, some medications come in capsules, like Cymbalta, which you can’t cut in half. For that medication, I actually opened the capsules and dumped out the tiny beads a little more each time as I tapered the dose. Most doctors and pharmacists advise against this practice, but it’s the only method that I found to be effective, because the lowest dose of Cymbalta is too high to get off of cold turkey. 

You can read more about how I took myself off Cymbalta here.

3. It’s Okay to Backtrack and Take a Break

It can feel like failure if you have to stop the tapering process or go slower than you planned — but it’s not. Just attempting the whole thing in the first place is itself a victory.

Whether or not you decide to attempt again, at least you have learned things only experience can teach you.

So, if you get started on a taper and you realize it’s too overwhelming or things are moving too fast, it’s okay to linger at a dose for a while until you’re ready.

In fact, it’s usually okay to taper back up to your original dose, as long as you do it slowly. Just keep in mind that for a lot of medications —and especially opioids — your tolerance level resets a lot quicker than most people realize.  So don’t jump back up too fast, or you could risk an overdose. 

You can read more tips for going off opioids here.

There’s so much about tapering off medications that a lot of people cannot fully understand until they go through it themselves. Make sure to give yourself lots of grace, and ignore anyone who tries to criticize your attempts – especially if they don’t have any personal experience in the matter.

All of these tips can go a long way toward making the whole process more tolerable and more successful. 

It may take time to find what works best for your body, but as long as you keep at it, you’ll figure out what works best for you.  

If you lost a loved to suicide after a change in their prescription pain medication, please consider participating in a survey to help researchers learn more about these tragic situations. Click here or on the banner below for more information.

Can Long-Term Opioid Use Be Predicted Before Surgery?

By Pat Anson

Patients on Medicaid and those who have a history of anxiety, mood disorders, or benzodiazepine use are significantly more likely to use opioids long-term after surgery, according to a new analysis.

The study, published in the journal Pain Medicine, could provoke fresh debate over whether opioid addiction can be predicted, and whether risk assessments unfairly stigmatize patients and affect how they are treated.

“Identifying who is at risk before the first incision is made is a critical step in combatting the opioid crisis,” said lead author Yoonjae Lee, DNP, a second-year PhD student at the University of Pennsylvania’s School of Nursing..

“Our findings provide a roadmap for clinicians to implement targeted interventions, ensuring that high-risk patients receive enhanced monitoring and alternative pain management strategies.”

Lee and her colleagues analyzed data from 27 clinical studies to see what raises the risk of patients new to opioids becoming long-term users after surgery. 

They found that “opioid-naïve” patients with Medicaid coverage and those with a history of taking benzodiazepine anti-anxiety medication had 77% higher odds of developing new persistent opioid use (NPOU). 

Patients with a history of depression or other mood disorders had 24% higher odds, while those with anxiety had a 17% higher risk of persistent opioid use.

Based on these findings, researchers say every patient should be screened before surgery for the risk of long-term opioid use, so that changes can be made in their treatment.

“Minimizing the development of NPOU requires a thorough preoperative medication review, as our findings indicated that certain drugs including antidepressants, muscle relaxants, anticonvulsants, and sedatives are linked to a higher risk of NPOU. Among these risk factors, preoperative benzodiazepine use stands out as the strongest,” researchers concluded.

“With respect to clinical implications, clinicians should adopt a comprehensive and individualized approach to assessing and managing these predictive factors in each surgical patient, given the complex interaction of multiple factors affecting the development of NPOU. Although insurance status cannot be changed, mood disorders, anxiety, and benzodiazepine use can be modified preoperatively.” 

The idea of pre-screening surgery patients is similar to female patients being screened for potential opioid misuse through a questionnaire called the Opioid Risk Tool. In some cases, the questionnaire has been used as an excuse to deny opioids to women who have a history of childhood sexual abuse.

Penn Nursing researchers may have an exaggerated notion of just how common long-term opioid use is after surgery. They cited a study claiming that “up to 65% of patients” continue to use opioids 90 days after surgery, a “significant postoperative complication” that leads to higher healthcare costs, as well as opioid misuse, diversion, overdose and addiction.

That’s a misleading reference to a 2024 analysis, which found that 2% to 65% of surgery patients are at risk of long term opioid use. That assessment is based on a review of over 30 clinical studies, which came up with a wide range of estimates on the risk of persistent opioid use. The Penn Nursing study only cited the higher 65% estimate, while ignoring the lower ones. 

Other studies have found that surgery patients rarely misuse opioids or become long-term users. A large 2018 Harvard Medical School study found that only 0.6% of patients had signs of opioid misuse after surgery.

A large 2016 study in Canada put the risk of long-term opioid use after one year at only 0.4% of surgery patients. “Our study thus provides reassurance that the individual risk of long-term opioid use in opioid-naive surgical patients is low,” researchers reported.

Neither the Canadian or Harvard study were included in the Penn Nursing analysis because researchers didn’t include studies conducted prior to 2019.

It’s fairly common for patients to need pain management for months after surgery. Post-operative pain becomes chronic in about 10% to 50% of surgery patients, depending on the type and invasiveness of the surgery. That’s why opioids and other analgesics are essential in post-op care. 

UK researchers say “great efforts must be made to provide effective post-operative pain relief for a long enough period” to prevent acute post-op pain from becoming chronic.

The Penn Nursing study was funded by the National Institutes of Health.

The Most Dangerous Drug in Canada Is Not Prescription Opioids

By Pat Anson

The most dangerous drug in Canada doesn’t require a prescription. You can’t smoke, vape, snort, or inject it. It doesn’t come in a pill, patch or edible.

It’s responsible for as many as 18-thousand deaths every year in Canada and can result in a lifetime of addiction. It ruins marriages, families, friendships and careers, and costs society about $20 billion a year in added healthcare expenses and lost productivity.

Yet it is readily available in most stores and can be purchased by anyone over the age of 19. In some provinces, the age limit is 18.

By now you’ve probably guessed that I’m talking about alcohol.

A new report by the Centre for Addiction and Mental Health (CAMH) found that alcohol causes more harm in Canada overall than any other drug — ranking well above tobacco, illicit fentanyl, cocaine, cannabis, methamphetamine and, yes, prescription opioids.

CAMH put together a diverse panel of 20 experts in public health, epidemiology, addiction, criminology, psychology and public policy to assess the short and long-term impact of 16 commonly used psychoactive drugs. In addition to the direct “harm to users” – such as addiction and overdose – they evaluated the indirect “harm to others” – families, communities and society at large.

“This is the first time this approach has been used to assess drug harms in Canada, and it gives us a much more complete picture than we had before,” said Jean-François Crépault, Senior Policy Advisor at CAMH and lead author of the study published in the Journal of Psychopharmacology. 

“When we look at harm to people who use drugs and harm to others together, alcohol clearly stands out. Our findings highlight a major gap between the harms linked to alcohol and the way it is currently regulated in Canada.”

Based on a ranking system of 0 to 100, with zero meaning no harm and 100 being the most harmful, alcohol was given a score of 79, followed by tobacco (45) and non-prescription opioids (33). The latter category includes illicit fentanyl, xylazine, and other opioid-based street drugs.

Cocaine (19), methamphetamine (19), cannabis (15) and crack (10) are next, with “prescription opioids” (8) ranked as the eighth most harmful drug category.

Even that ranking is a bit misleading, as it includes morphine, oxycodone and other pharmaceutical opioids that are diverted and used without a prescription – which probably should be counted as non-prescription opioids.

Prescription opioids were ranked so low in terms of harm, they barely beat out ENDs (7), an acronym for electronic nicotine delivery systems, more commonly known as vapes or e-cigarettes.

Most Harmful Drugs in Canada

JOURNAL OF PSYCHOPHARMACOLOGY

The finding that alcohol causes the most harm aligns with previous studies in the United Kingdom, the European Union, Australia and New Zealand.

In the United States, a recent study that used a slightly different methodology ranked alcohol as the 5th most harmful drug, behind illicit fentanyl, methamphetamine, crack and heroin. Prescription opioids ranked as the 7th most harmful drug in the U.S.

Experts say these studies point to a clear need for government drug policies to better align with the actual harm that a specific drug causes – and not be based on laws, guidelines, class action lawsuits, or whatever drug hysteria is popular at the moment. 

Despite all the harm it causes, no one talks about banning alcohol, yet natural leaf kratom and the kratom extract 7-OH are being demonized as “gas station heroin” and “legal morphine” that should be banned. Never mind that there is little solid evidence they are dangerous when used appropriately. Neither substance made the “harmful” list in Canada, United States, or anywhere else.

“The key message here is that harm is not just about what a drug does to the body,” said Crépault. “How a drug is regulated shapes who uses it, how it is used, and how much harm it causes. Evidence-based policy can significantly reduce harm, and governments have a real opportunity to use regulation to protect public health.”

CDC Opioid Guideline Raised Cost of Pain Care

By Pat Anson

The CDC’s 2016 opioid prescribing guideline not only had disastrous consequences for many pain patients, but raised the cost of treating them in primary care practices, according to a new analysis.

Researchers at the University of Wisconsin-Madison studied the budget impact of four different strategies used at primary care clinics to comply with the guideline, which strongly encouraged doctors to reduce opioid prescribing. 

The strategies primarily relied on prescriber education, evaluations and auditing to see if the clinics were successful in reducing the use of opioids. Whether patient safety and pain relief improved were not part of the study.

The cost per clinic for implementing the strategies ranged from $4,416 to $8,358, with prescriber education being the cheapest approach. However, while education alone cost less upfront, the clinics that used it had the largest increases in downstream expenses, such as greater use of urine drug tests (UDTs), treatment agreements, and depression screening. That made it the most costly approach overall.       

The 2016 guideline recommended that doctors limit daily opioid doses to no more than 90 morphine milligram equivalents (MMEs), conduct regular drug testing of patients, and have patients sign “pain contracts” promising to follow their doctor’s treatment plan.

The CDC’s recommendations were not only costly and burdensome to providers, according to researchers, but resulted in “no significant decrease” in MME for patients on long-term opioid therapy. Patients on opioid therapy for less than 3 months saw their doses decline by 6%. 

“In summary, from 2016 to 2022, no evidence emerged showing that UDTs were effective in improving long-term outcomes such as decreased overdoses or better pain management,” wrote lead author Andrew Quanbeck, PhD, an Associate Professor in the University of Wisconsin's Department of Family Medicine and Community Health.

“Over time, treatment agreements and UDTs have emerged as low-value care that imposes significant costs for primary care physicians and patients. Results suggest that health systems have an opportunity to shift focus from costly surveillance tools to inexpensive, holistic screening for pain, function, and quality of life and careful initiation of opioids for new patients.”  

The study, published in the Annals of Family Medicine, is one of the few to analyze the long-term impact of the original CDC guideline.  

It’s important to note that the CDC updated its guideline in 2022 to give more “flexibility” to doctors prescribing opioids. However, many of the agency’s 2016 recommendations were so stringently adopted by states, healthcare systems, insurers, and even law enforcement agencies that they remain unchanged – even though there were many reports of patients being harmed by them.

“It is clear that the CDC Guideline has harmed many patients,” the American Medical Association wrote in a 2020 letter to the CDC. “In many cases, health insurance plans and pharmacy benefit managers have used the 2016 CDC Guidelines to justify inappropriate one-size-fits-all restrictions on opioid analgesics while also maintaining restricted access to other therapies for pain.”

The Food and Drug Administration also warned the CDC guideline was causing “serious harm” to patients, including forced tapers, uncontrolled pain, psychological distress and suicide.    

In a 2022 PNN survey of over 2,500 patients and providers, nearly 85% said the CDC should not have created guidelines for opioid prescribing and pain treatment. Over 93% said the guidelines made the quality of pain care in the United States worse.

Gabapentin ‘Free for All’ in Addiction Treatment  

By Pat Anson

The nerve drug gabapentin is increasingly being prescribed to patients undergoing treatment for substance use disorder (SUD), according to two new studies that highlight how the drug is being abused and used to treat health conditions it was never intended to treat.

The first study, published in the journal Drug and Alcohol Dependence, looked at over 200,000 urine drug test results analyzed by Millennium Health, which were collected from patients undergoing SUD treatment in all 50 U.S. states.   

Over the past decade, gabapentin (Neurontin) prescribing to patients in addiction treatment nearly doubled, from 3.9% in 2016 to 7.6% in 2023. In addition, nearly one in ten patients being treated for SUD tested positive for gabapentin, even though they didn’t have a prescription for it.    

“A lot of that use is off label, and in the context of substance use, we're seeing it being prescribed to manage withdrawals, or for insomnia, pain, and anxiety. It’s just sort of a free-for-all in how it's prescribed,” says lead author Matthew Ellis, PhD, an Assistant Professor of Psychiatry at Washington University School of Medicine. 

“I think one of the big findings was that the positivity rate for those without a prescription for gabapentin was twice as big as those prescribed gabapentin.”

Gabapentin was originally developed as an anti-convulsant. It was first approved by the FDA as a treatment for epilepsy and later for neuropathic pain caused by shingles. But it is also routinely prescribed off-label for migraine, fibromyalgia, bipolar disorder, cancer pain, postoperative pain, and many other conditions.

Its off-label use as a pain reliever grew after the CDC recommended gabapentin in 2016 as an alternative to opioid analgesics. By 2024, gabapentin was prescribed to 15.5 million Americans, making it the fifth most prescribed drug in the U.S. 

Due to the nature of the study, Ellis says it’s difficult to know if patients were prescribed gabapentin before entering SUD treatment or if they started taking it after treatment started to help manage symptoms of withdrawal. Gabapentin prescribing increased to all patients, whether they were being treated for alcohol, cannabis, stimulant, sedative or opioid abuse.

Another possibility is that patients take gabapentin to heighten the effects of addiction treatment drugs like buprenorphine (Suboxone) or methadone. Gabapentin is prized as a street drug because it helps increase the euphoria or “high” that comes from psychoactive substances. 

“I don't want to give gabapentin a bad name at all. I think there's definitely potential for it. I think my biggest issue is that there's just so little evidence base for its use in substance use treatment settings,” Ellis told PNN. 

“And to have so many people using it outside of a prescription, it just may be a call to recognize that, one, there may be untreated comorbid conditions that people are self managing, or two, we need to do a lot better about building an evidence base to see what exactly is or could be the benefit of gabapentin in substance use treatment.”

One positive trend uncovered by the study is that the use of gabapentin without a prescription has declined in drug treatment settings, from 15.2% of patients to 9.9%. 

The second study, published in the same journal, also found that gabapentin prescribing has significantly increased over the past decade, but that its “nontherapeutic” use (another term for misuse) appears to be declining. 

Despite the decrease in misuse, FDA researchers found that the number of cases reported to U.S. poison control centers involving gabapentin greatly exceeded those for pregabalin (Lyrica) and the anti-anxiety drug diazepam. Most of the gabapentin cases involved other substances, particularly opioids. 

New Medicaid Policy Won't Pay for Costly Sickle Cell Therapies Unless They Work

By Phil Galewitz, KFF Health News

Serenity Cole enjoyed Christmas last month relaxing with her family near her St. Louis home, making crafts and visiting friends.

It was a contrast to how Cole, 18, spent part of the 2024 holiday season. She was in the hospital — a frequent occurrence with sickle cell disease, a genetic condition that damages oxygen-carrying red blood cells and for years caused debilitating pain in her arms and legs. Flare-ups often would force her to cancel plans or miss school.

“With sickle cell it hurts every day,” she said. “It might be more tolerable some days, but it’s a constant thing.”

In May, Cole completed a several-months-long gene therapy treatment that helps reprogram the body’s stem cells to produce healthy red blood cells.

She was one of the first Medicaid enrollees nationally to benefit from a new payment model in which the federal government negotiates the cost of a cell or gene therapy with pharmaceutical companies on behalf of state Medicaid programs — and then holds them accountable for the treatment’s success.

Under the agreement, participating states will receive “discounts and rebates” from the drugmakers if the treatments don’t work as promised, according to the Centers for Medicare & Medicaid Services.

SERENITY COLE

That’s a stark difference from how Medicaid and other health plans typically pay for drugs and therapies — the bill usually gets paid regardless of the treatments’ benefits for patients. But CMS has not disclosed the full terms of the contract, including how much the drug companies will repay if the therapy doesn’t work.

The treatment Cole received offers a potential cure for many of the 100,000 primarily Black Americans with sickle cell disease, which is estimated to shorten lifespans by more than two decades. But the treatment’s cost presents a steep financial challenge for Medicaid, the joint state-federal government insurer for people with low incomes or disabilities. Medicaid covers roughly half of Americans with the condition.

There are two gene therapies approved by the Food and Drug Administration on the market, one costing $2.2 million per patient and the other $3.1 million, with neither cost including the expense of the long hospital stay.

The CMS program is one of the rare health initiatives started under President Joe Biden and continued during the Trump administration. The Biden administration signed the deal with the two manufacturers, Vertex Pharmaceuticals and Bluebird Bio, in December 2024, opening the door for states to join voluntarily.

“This model is a game changer,” Mehmet Oz, the CMS administrator, said in a July statement announcing that 33 states, Washington, D.C., and Puerto Rico had signed onto the initiative.

Asked for further details on the contracts, Catherine Howden, a CMS spokesperson, said in a statement that the terms of the agreements are “confidential and have only been disclosed to state Medicaid agencies.”

“Tackling the high cost of drugs in the United States is a priority of the current administration,” the statement said.

Citing confidentiality, two state Medicaid directors and the two manufacturers declined to reveal the financial terms of agreements.

‘A Worthy Experiment’

The gene therapies, approved in December 2023 for people 12 or older with sickle cell disease, offer a chance to live without pain and complications, which can include strokes and organ damage, and avoid hospitalizations, emergency room visits, and other costly care. The Biden administration estimated that sickle cell care already costs the health system almost $3 billion a year.

With many more expensive gene therapies on the horizon, the cost of the sickle cell therapies presages financial challenges for Medicaid. Hundreds of cell and gene therapies are in clinical trials, and dozens could get federal approval in the next few years.

If the sickle cell payment model works, it will probably lead to similar arrangements for other pricey therapies, particularly for those that treat rare diseases, said Sarah Emond, president and CEO of the Institute for Clinical and Economic Review, an independent research institute that evaluates new medical treatments. “This is a worthy experiment,” she said.

Setting up payment for drugs based on outcomes makes sense when dealing with high treatment costs and uncertainty about their long-term benefits, Emond said.

“The juice has to be worth the squeeze,” she said.

Clinical trials for the gene therapies included fewer than 100 patients and followed them for only two years, leaving some state Medicaid officials eager for reassurance they were getting a good deal.

“What we care about is whether services actually improve health,” said Djinge Lindsay, chief medical officer for the Maryland Department of Health, which runs the state’s Medicaid program. Maryland is expected to begin accepting patients for the new sickle cell program this month.

Medicaid is already required to cover almost all FDA-approved drugs and therapies, but states have leeway to limit access by restricting which patients are eligible, setting up a lengthy prior authorization process, or requiring enrollees to first undergo other treatments.

While the gene therapy treatments are limited to certain hospitals around the country, state Medicaid officials say the federal model means more enrollees will have access to the therapies without other restrictions.

The manufacturers also pay for fertility preservation such as freezing reproductive cells, which could be damaged by chemotherapy during the treatment. Typically, Medicaid doesn’t cover that cost, said Margaret Scott, a principal with the consulting firm Avalere Health.

Emond said pharmaceutical companies were interested in the federal deal because it could lead to quicker acceptance of the therapy by Medicaid, compared with signing individual contracts with each state.

States are attracted to the federal program because it offers help monitoring patients in addition to negotiating the cost, she said. Despite some secrecy around the new model, Emond said she expects a federally funded evaluation will track the number of patients in the program and their results, allowing states to seek rebates if the treatment is not working.

The program could run for as long as 11 years, according to CMS.

“This therapy can benefit many sickle cell patients,” said Edward Donnell Ivy, chief medical officer for the Sickle Cell Disease Association of America.

He said the federal model will help more patients access the treatment, though he noted utilization will depend in part on the limited number of hospitals that offer the multimonth therapy.

Hope for Sickle Cell Patients

Before gene therapy, the only potential cure for sickle cell patients was a bone marrow transplant — an option available only to those who could find a suitable donor, about 25% of patients, Ivy said. For others, lifelong management includes medications to reduce the disease’s effects and manage pain, as well as blood transfusions.

About 30 of Missouri’s 1,000 Medicaid enrollees with sickle cell disease will get the therapy in the first three years, said Josh Moore, director of the state’s Medicaid program. So far, fewer than 10 enrollees have received it since the state began offering it in 2025, he said.

Less than a year into the federal program, Moore said it’s too early to tell its rate of success — defined as an absence of painful episodes that lead to a hospital visit. But he hopes it will be close to the 90% rate seen over the course of a couple of years in clinical trials.

Moore said the federal program based on how well the treatment works was preferred over cutting fees for a new and promising therapy, which would put the manufacturers’ ability to develop new drugs at risk. “We want to be good stewards of taxpayer dollars,” he said.

He declined to comment on how much the state may save from the arrangement or disclose other details, such as how much the drug companies might have to pay back, citing confidentiality of the contracts.

Lately Cole, who underwent gene therapy at St. Louis Children’s Hospital, has been able to focus on her hobbies — playing video games, drawing, and painting – and earning her high school diploma.

She said she was glad to get the treatment. The worst part was the chemotherapy, she said, which left her unable to talk or eat — and entailed getting stuck with needles.

She said that her condition is “way better” and that she has had no pain episodes leading to a hospital stay since completing the therapy last spring. “I’m just grateful I was able to get it.”

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

Prohibition Medicine and the Collapse of Patient Safety

By Michelle Wyrick

For more than a decade, the United States has been running a vast, uncontrolled policy experiment in medical care. Under the banner of “opioid reduction” and “overdose prevention,” regulators have steadily restricted, stigmatized, and in many cases effectively eliminated access to stable, physician-supervised treatment for pain, anxiety, and other chronic disabling conditions.

The results of this experiment are now visible everywhere, and they are not subtle. Patients are sicker, more desperate, more marginalized, and more exposed to dangerous unregulated substances than at any point in modern medical history.

This outcome should not surprise anyone. It is not an accident. It is the predictable result of applying prohibition logic to medicine.

When legitimate patients are cut off from stable, supervised, pharmaceutical-grade treatment, they do not stop having pain. They do not stop having anxiety, severe depression, neurological disease, connective tissue disorders, autoimmune conditions, or the many other illnesses that produce chronic suffering.

They look for substitutes. And there will always be substitutes.

This is not a moral statement. It is a basic fact of human biology and behavior.

Demand for relief from suffering is not eliminated by supply restrictions. It is merely displaced into less safe, less predictable, and less medically supervised channels.

This dynamic is not unique to opioids. It is a universal feature of prohibition systems. Alcohol prohibition in the early 20th century did not end drinking. It drove production into unregulated, often toxic forms and empowered criminal supply chains. Modern drug prohibition has not eliminated drug use. Instead, it has ensured that the drugs people do use are increasingly potent, adulterated, and dangerous.

The same pattern is now playing out inside medicine itself.

For decades, physicians used opioid analgesics, benzodiazepines, and other controlled medications in a personalized, risk-benefit framework. This was not perfect medicine, but it was recognizable medicine. Doctors assessed individual patients, monitored them, adjusted doses, and discontinued treatment when risks outweighed benefits. The vast majority of stable patients used these medications without chaos, without dose escalation, and without the kinds of outcomes now routinely attributed to the “opioid crisis.”

Beginning in the mid-2010s, this model was replaced with something very different. Guidelines were transformed into rigid limits. Clinical judgment was replaced by fear of regulators. Medical boards, insurers, pharmacies, and hospital systems began enforcing population-level dose ceilings and forced tapering policies that took little or no account of individual patient physiology, genetics, or clinical history.

This shift was justified using public health language, but it was not actually evidence-based medicine. It was administrative medicine.

The core assumption behind this approach was simple and deeply flawed. If you reduce access to prescription opioids, you reduce addiction and overdose.

In the real world, the opposite happened.

As prescription access fell, overdose deaths rose. Not slowly. Not ambiguously. They rose sharply and continuously, driven almost entirely by illicit synthetic opioids such as fentanyl and its analogues. This is not a coincidence. It is substitution.

When patients and non-patients alike lose access to regulated, dosed, known substances, the market does not disappear. It mutates. It becomes more concentrated, more dangerous, and more lethal.

From a pharmacological standpoint, this is exactly what one would predict. When supply is restricted, traffickers move to higher potency products that are easier to transport and conceal. This is why fentanyl replaced heroin, and why heroin replaced opium, and why alcohol prohibition favored spirits over beer. The same pressure operates everywhere prohibition is applied.

In medicine, this has produced a grotesque paradox. The very policies sold as “harm reduction” have forced more people into the most dangerous drug environment in history.

But the harm does not stop with overdose statistics.

For millions of legitimate patients, the new regime has meant something quieter but equally devastating. Forced tapers. Sudden discontinuations. Blacklisting by pharmacies. Doctors who will not treat pain at all. Clinics that advertise only “non-opioid” care, regardless of diagnosis, severity, or prior response.

These patients are often described in policy discussions as if they were abstractions. In reality, they are people with connective tissue disorders, spinal injuries, advanced arthritis, neuropathies, autoimmune diseases, post-surgical damage, and complex multi-system conditions. Many were stable for years or decades. Many were functional. Many worked, raised families, and lived ordinary lives.

When their treatment is removed, they do not return to some baseline healthy state. They collapse.

Some become housebound. Some lose the ability to work. Some develop severe depression and suicidality. Some are driven, reluctantly and fearfully, to seek relief outside the medical system.

This is the part of the story that is still not being honestly confronted.

People do not seek unregulated substances because they want to. They seek them because the medical system has left them with no humane alternative.

This is not “addiction” in the simplistic, moralized sense that is often implied. It is survival behavior in the context of untreated suffering.

From a systems perspective, the current policy framework violates one of the most basic principles of risk management. If you remove a safer, regulated option while demand remains constant, you do not eliminate risk. You increase it.

Pharmaceutical-grade medications have known dosages, known purity, known pharmacokinetics, and some degree of medical oversight. Gray and black market substances do not. They vary wildly in potency. They are often contaminated. They are frequently misrepresented. The margin for error is small, and the consequences of error are fatal.

This is why the shift from prescription opioids to illicit fentanyl has been so deadly. It is not because fentanyl is uniquely evil. It is because unregulated supply chains, extreme potency, and unpredictable dosing is a perfect storm.

A rational harm-reduction strategy would aim to pull people into safer, supervised, medically controlled channels. Instead, current policy does the opposite.

It pushes people out.

There is also a deeper scientific problem with the one-size-fits-all approach that now dominates pain and psychiatric care. Human beings do not respond to drugs uniformly. Genetics, metabolism, receptor expression, enzyme function, comorbid conditions, and prior exposure all profoundly shape both benefit and risk. Pharmacogenetics has made this increasingly obvious, yet policy continues to pretend that a single dosage threshold can define safety for everyone.

This is not medicine. It is bureaucratic simplification masquerading as science.

Some patients tolerate and benefit from opioid therapy at doses that would be excessive for others. Some cannot tolerate even low doses. Some respond better to one class of medication than another. The same is true for benzodiazepines, antidepressants, stimulants, and nearly every drug class in existence.

The proper response to this variability is individualized care, not blanket restriction.

Instead, clinicians are now taught, implicitly and explicitly, that avoiding regulatory risk matters more than relieving suffering. The result is widespread medical abandonment.

From an ethical standpoint, this should be alarming. Medicine is supposed to be organized around the care of the patient in front of the clinician, not the appeasement of distant agencies.

From a public health standpoint, it is also failing by its own stated metrics. Overdose deaths continue. Illicit markets continue to grow. Patients continue to be driven out of care.

This is not because the problem is unsolvable. It is because the framing is wrong.

We are not dealing with a battle between “medicine” and “drugs.” We are dealing with a battle between regulated, supervised, accountable systems and unregulated, chaotic, lethal ones.

History has already shown us how this ends. Every time.

Prohibition logic has never worked in any domain. Not alcohol. Not drugs. Not sex work. Not abortion. Not gambling. It does not eliminate demand. It ensures that demand is met in more dangerous ways.

If policymakers actually cared about safety and harm reduction, they would reverse course.

They would restore rational, individualized medical prescribing. They would protect clinicians who practice careful, documented, patient-centered care. They would stop forcing stable patients into destabilizing tapers. They would bring people back into the healthcare system instead of pushing them into gray and black markets.

They would also start telling the truth about what has happened.

The current crisis is not the result of doctors prescribing too compassionately. It is the result of a system that replaced medicine with fear, and then called the outcome “public health.”

We can continue down this path, and watch the death toll and human suffering rise year after year. Or we can admit what history, pharmacology, and basic systems theory already tell us.

You cannot ban your way to safety.

You can only regulate, supervise, and care your way there.

And right now, we are doing the opposite.

Michelle Wyrick is a Board Certified Psychiatric Registered Nurse and a Clinical Hypnotist in Gatlinburg, Tennessee.