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.

Taking Tylenol During Pregnancy Does Not Increase Baby’s Risk of Autism or ADHD 

By Anya Arthurs

If you’ve been pregnant in the past few months, you may have faced a dilemma. You wake up with a fever, a pounding headache or back pain – and then pause. Is it safe to take paracetamol?

That hesitation isn’t surprising. In September last year, the United States government sowed widespread doubt and anxiety by linking paracetamol use in pregnancy to autism and attention-deficit hyperactivity (ADHD).

But now a major new international study, published in The Lancet, provides some much-needed clarity.

The research confirms that taking paracetamol – also known as acetaminophen, or by brand names such as Panadol and Tylenol – does not increase a baby’s risk of autism, ADHD or intellectual disability when used in pregnancy.

Paracetamol remains a safe and effective way to treat fever and pain at any stage of pregnancy.

Large Review of Studies

The researchers carried out a large systematic review and meta-analysis, meaning they didn’t just study one group of people. Instead, they pulled together results from many previous studies.

In total, they reviewed 43 studies that focused on whether children exposed to paracetamol in the womb were more likely to later be diagnosed with autism, ADHD or intellectual disability.

Crucially, the authors prioritised sibling-comparison studies. Sibling studies compare siblings from the same family, where one used paracetamol during pregnancy and another didn’t.

This approach produces higher-quality results for comparison. It helps researchers isolate what they’re studying – in this case, paracetamol.

Siblings’ shared genetics, home environment and family background mean there won’t be differences in these factors, which could distort results (known as “confounding factors”).

The authors used extensive statistical methods to ensure their results were accurate.

What They Found

Across these higher-quality studies, the researchers found no meaningful increase in the risk of autism, ADHD, or intellectual disability in children whose mothers used paracetamol during pregnancy.

This was true when the authors (a) looked only at sibling studies, (b) focused on studies with low risk of bias and (c) examined children followed for more than five years.

In other words, when the strongest methods were used, the earlier alarming links simply didn’t hold up. The study concludes that paracetamol, when used as directed, remains safe during pregnancy.

These results echo those of another landmark study in 2024, conducted in Sweden and including almost 2.5 million children (born between 1995 and 2019).

This Swedish study illuminated the need for good controls in scientific research.

It showed when studies didn’t use sibling comparison as a way to control confounding factors, there appeared to be a small increased risk of autism and ADHD associated with using paracetamol while pregnancy.

However, when the researchers used rigorous statistical methodology in sibling studies to account for the confounding factors between people – differences such as genetics or living conditions – these associations disappeared.

The Swedish study, just like the current Lancet study, also concluded there was absolutely no evidence of increased risk of autism, ADHD or neurodevelopmental disability with paracetamol use in pregnancy.

Why It’s Important

Paracetamol isn’t just another medication. It’s often the only recommended option for treating pain and fever in pregnancy.

The Therapeutics Goods Administration, responsible for regulating medication safety and quality in Australia, maintains that paracetamol remains a pregnancy “Category A” drug. This means it is safe for use in pregnancy when used according to directions.

Being able to rely on a safe drug to reduce fever is really important for pregnant people.

Leaving fever untreated during pregnancy can be harmful for both the fetus and the mother. Fever in pregnancy has been linked to miscarriage, pre-term birth and birth complications.

So avoiding paracetamol “just in case” in fact isn’t a cautious choice. The risks of not treating pain or fever may be greater than the risks of the medication itself.

For pregnant people weighing up whether to take a tablet for a feverish night or pregnancy aches, this study should help reassure them taking paracetamol is safe and evidence-based.

Paracetamol remains, as it has for decades, the first-line option.

If you have concerns, speak to your health-care provider.

Anya Arthurs, PhD, is a Research Fellow in Cell and Molecular Biology in the College of Medicine and Public Health at Flinders University in Australia. 

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

Utah Launches AI-Powered Prescription Refills

By Crystal Lindell

Utah is testing a new AI-powered prescription drug service that allows people to skip seeing the doctor if they need a medication refilled for some chronic conditions.

The program is powered by Doctronic, a telehealth service that uses artificial intelligence to act in the role of a doctor, asking patients questions that are typically asked during a refill appointment.

The renewal process will take less than five minutes and Doctronic will charge just $4 for the service.

“If you’re in the state of Utah and you need let’s say a statin renewed because you have high cholesterol and you don’t have any more renewals left on your prescription, but you’ve already been taking that statin, you can talk to our AI,” Matt Pavelle, Co-CEO of Doctronic, told ABC4 in Salt Lake City

“It’s going to lead you through the process as a human doctor would, ask all of the right questions, look up all the right interactions, make sure that it’s safe for you…to receive that renewal. It will approve that and send it to a pharmacy in Utah for you.”

The list of medications that Doctronic will refill is limited. The strongest pain relievers you can get are prescription strength acetaminophen and NSAIDs. Other medications used by people with chronic conditions like diabetes are also unavailable.

“The program does not fill prescriptions for controlled substances, such as opioids or ADHD medications, nor are injectables eligible, such as insulin or semaglutide/weight-loss drugs,” a spokesperson for the Utah Department of Commerce told PNN.

Maybe Utah’s program will work as they claim and using it will be even better than talking or seeing a human doctor. But I’m skeptical.

A program like this has the potential to help patients, but it comes with a lot of questions about how it will work in practice – especially given how horrible customer service AI bots have been in general. From personal experience, I can tell you that they are often impossible to communicate with.

I also worry about how accurate Doctronic is, given that other AI bots like ChatGPT can have an error rate of 52%. When it comes to medical decisions, that kind of error rate can be deadly. 

In case of a problem or error with a prescription, Doctronic could be held liable. According to ABC4, Doctronic is covered by a malpractice insurance policy

AI prescription refills could save patients from the cost and hassle of a doctor’s appointment, but if a program like this really takes off, I am certain that the companies running them will then increase the price of each AI appointment. 

In the end, if it was safe to continue prescribing a medication without checking in with a human doctor, the human doctor could easily allow for multiple refills..

And if a human doctor is not needed as part of the equation, why is an AI doctor even needed?

Theoretically, if human doctors are not needed, commonly renewed medications could just have a check-in questionnaire that patients fill out when they need more refills. A doctor would only get involved if any of the responses warranted it.

I would wager such a program would be significantly more accurate, but also significantly more difficult to launch. The lack of a buzzy AI angle would probably be a turn off for both lawmakers and medical professionals.  

There’s also the issue of losing the patient-to-doctor interaction, where other health issues are often flagged and treated. This program all but eliminates that possibility. 

It will be interesting to see how patients and doctors respond to the Doctronic program, and whether they like actually using it. I fully support making healthcare and prescriptions more affordable and accessible. I am just not convinced that an AI chatbot is the best way to achieve either of those goals. 

DEA Cuts Oxycodone Supply, But Raises Production of Morphine in Surprise Move

By Pat Anson

The Drug Enforcement Administration is moving ahead with its plan to reduce the supply of oxycodone by over 6% in 2026, while at the same time significantly raising its production quota for morphine. There will be small reductions in the supply of hydrocodone, codeine and other Schedule II opioids this year.

The move to increase the supply of morphine by 10.5% is surprising, as the agency proposed cutting morphine production by over half a percent a little over a month ago. 

The DEA officially announced its plans January 5 in the Federal Register, 35 days after a December 1 deadline set for the agency in the Controlled Substances Act (CSA). Under the CSA, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for opioids and other controlled substances. 

The December 1 deadline is important because it gives the pharmaceutical industry time to prepare for the coming year by adjusting drug manufacturing and distribution schedules. The DEA’s chronic failure to meet that deadline in previous years has contributed to shortages, according to drug makers.

Over 5,000 public comments were received by the DEA in response to the agency’s initial APQs for 2026. Most comments pleaded with the agency not to make any further cuts in the supply of opioids, many of which are already in short supply at pharmacies and hospitals. 

“I oppose cutting production for controlled medications at this time as there is already a shortage for many of these medications and patients are often not able to obtain their prescriptions. Cutting production during a shortage will only exacerbate the problem and increase patient suffering,” Hannah Khalil wrote in a public comment echoed by many others. 

The DEA, however, was dismissive of claims about opioid shortages, saying it was not responsible for them.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the DEA said. “Currently, FDA has not listed on its Drug Shortage website any nationwide shortages of oxycodone and hydrocodone products.”

While it is true the FDA does not currently have oxycodone or hydrocodone on its shortage list, the American Society of Health-System Pharmacists (ASHP) has listed both opioids on its shortage list since 2023. Limited supplies of oxycodone and hydrocodone are available from some manufacturers, according to the ASHP, while others have the medications on back order.

The difference between the FDA and ASHP shortage lists is that the FDA relies on drug manufacturers to report shortages, while the ASHP proactively surveys both pharmacies and drug makers about their inventories. That arguably makes it superior to the FDA’s methodology.

Ironically, the DEA itself has challenged the reliability of the FDA’s drug shortage list.

“DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the General Accountability Office (GAO) said in a 2015 audit report. “They do not believe FDA appropriately validates or investigates the shortages.”

Increased Morphine Production

The DEA offered no explanation for the increase in morphine production. The production quota for morphine is 10.55% higher than last year's quota and the highest amount since 2021.

One likely reason for the DEA’s decision is that the FDA recently added morphine tablets and injectable morphine solutions to its shortage list, due to discontinuations and short supplies. The ASHP has listed morphine in shortage for several months. 

Morphine solutions and other injectable opioids are an important resource in hospitals, emergency rooms and surgery centers, where they are used in post-op care, sedation and anesthesia.

Morphine tablets are most often used to treat severe chronic pain.

I fear there will be continued shortages resulting in many patients suffering from the DEA’s quota decisions.
— Dr. Lynn Webster, pain management expert

“In 2025, there were major shortages of morphine immediate release (15-mg, 30-mg tablets) and morphine extended release (mostly 30-mg tablets) that lasted 3-4 months and were disruptive to care. I mentioned morphine in my personal, submitted comments (to the Federal Register),” said Chad Kollas, MD, a palliative care physician in Florida.

“I suspect that others also complained about last year’s morphine shortages, which may have led to the increase in production of morphine in 2026. It is also the cheapest of the traditional opioids, which may have played a role in the decision. I’m disappointed that they held the line on the oxycodone reduction.”

“I don't know why the DEA would reduce oxycodone while increasing the morphine quota. It seems illogical since there are reports that both are in shortage at the clinical level,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “I fear there will be continued shortages resulting in many patients suffering from the DEAs quota decisions.  

“They know patients are struggling to get access to both medications but they may think oxycodone is more likely to be abused than morphine. It appears they are trying to tell providers what they should prescribe. Yet they are not supposed to be involved in determining how medicine is practiced. Whether intentional or not, that is exactly what they are doing.”

Even with this year’s increase in morphine production, DEA has reduced the supply of morphine by over 63% since 2015. Steep declines have also been made in quotas for hydrocodone (-73%), oxycodone (-71%), and codeine (-70%) over the past decade.  

The DEA began cutting the opioid supply in response to pressure from Congress and anti-opioid activists, who claimed that prescription opioids were responsible for soaring overdose rates. While that claim has been largely debunked, opioid prescribing has continued to fall, as doctors became fearful of being accused of “overprescribing.”

The DEA says the “medical usage” of opioids fell by 10.5% in 2024 alone. The agency expects  that trend to continue, while dismissing claims that its shrinking opioid production quotas have interfered with the practice of medicine. 

“DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards,” DEA said. 

The 5 Most Popular PNN Stories of 2025

By Crystal Lindell

Looking back at 2025, there was a lot of news to cover when it came to chronic pain and illness. Access to opioids was again a major concern for our readers, but there was also a lot of interest in the potentially harmful effects of gabapentin.

Below is a look at the top 5 most widely read articles that PNN published in 2025.

We truly appreciate every time you read, comment and share our articles. And we can’t wait to bring you more great coverage in 2026! 

1) Over 15 Million Americans Prescribed Gabapentin Despite Warnings

In September, we covered an analysis by CDC researchers that showed that the use of gabapentin (Neurontin) continued to soar in the United States — usually for chronic pain and other health conditions the drug is not approved to treat. 

Gabapentin is the fifth most prescribed drug in the United States, with prescriptions nearly tripling since 2010, according to findings published in the Annals of Internal Medicine. The number of patients prescribed gabapentin reached 15.5 million in 2024, up from 5.8 million in 2010.

Read the full article here.  

2) Cannabis Use by Older Adults Linked to ‘Younger Brains’ and Improved Cognition

In August, we covered a study that showed that cannabis use by older adults slowed the aging of their brains and may even improve cognitive function.  

An international research team analyzed health data on more than 25,000 adults in the UK, looking at the relationship between cannabis use, aging, and cognitive function. They found that cannabis users had brain characteristics “typically associated with younger brains” and “enhanced cognitive abilities.” 

Read the full article here

3) 6 Things to Try If Your Doctor Won’t Prescribe Opioid Pain Medication

A lot of pain patients find that their doctors are reluctant to prescribe opioids. So in February, I shared six things to try if your physician tells you to go home and take ibuprofen.

The first tip is not to give up. Tell your doctor what poorly treated pain is doing to your life – that you’re unable to work or that you may have to go to the emergency room. Tell the truth and don’t exaggerate, and you just might get them to change their mind.

Another option is to try kratom and/or cannabis. They don’t work for everyone, but many patients say they provide some level of pain relief.  

Read the full article here. 

4) DEA Plans Further Cuts in Oxycodone Supply

In November, we covered the DEA’s plan to cut the supply of oxycodone by more than 6% in 2026, along with marginal reductions in the supply of hydrocodone, morphine and other Schedule II opioids. 

From year-to-year, the cuts may not appear significant. But over the past decade, there has been an historic decline in the nation’s opioid supply. If its current plan is adopted, DEA will have cut the supply of hydrocodone and oxycodone by over 70% since 2014.

The DEA says the “medical usage” of prescription opioids is declining, when in fact the “medical need” for them is actually increasing.

Read the full article here

5) Study Links Gabapentin to Increased Dementia Risk 

In July, we covered how gabapentin (Neurontin) may significantly increase the risk of dementia and cognitive impairment, even for middle-aged patients who only took the nerve medication for six months.

That was according to research published in the Regional Anesthesia & Pain Medicine journal, which looked at health records for more than 26,000 U.S. patients with chronic low back pain.

Researchers found that patients with six months or more of gabapentin use had a 29% higher risk of developing dementia and an 85% higher risk of developing mild cognitive impairment 

Read the full article here.

We hope you enjoyed reading PNN in 2025 and that you found our stories informative and helpful. We look forward to continuing our coverage of chronic pain and other health issues in 2026. 

Unlike many other online news outlets, we don’t hide behind a paywall or charge for subscriptions. PNN depends on reader donations to continue publishing, so please consider making a donation today.

Happy New Year everyone!

‘Stop This Insanity’: Pain Patients Plead with DEA Not to Cut Opioid Supply Again

By Pat Anson

Thousands of people have left public comments in the Federal Register, most of them sharply critical of the Drug Enforcement Administration’s plan to reduce the supply of opioids and other Schedule II controlled substances in 2026.

If enacted without any changes, the DEA’s proposal would be the 10th consecutive year the agency has reduced aggregate production quotas (APQs) for manufacturers of opioid pain medication. 

The biggest cut next year would be in the supply of oxycodone – a reduction of 6.24% – a pain medication that is already in short supply, according to the American Society of Health-System Pharmacists.

“When cutting the production of this medication, you are harming millions of innocent victims, whose life has been taken from injury/illness and rely on pain medication daily to survive and have a quality of life,” wrote Charl Revelo. “We are not criminals. We are innocent pain patients.”

Revelo is one of over 5,000 people who left comments in the Federal Register – a hefty turnout, given that the DEA only allowed 15 days for public comments, about half the usual comment period for quota proposals. December 15 was the last day comments were accepted.

Over the past decade, DEA has reduced the supply of oxycodone and hydrocodone by over 70 percent –  citing a decline in “medical usage” and fewer requests from drug manufacturers. 

But “medical usage” does not reflect a decline in medical need. Chronic pain has actually risen in the U.S. and now affects about 60 million people, including 21 million with high-impact pain – pain strong enough to limit daily life and work activity, which is often treated with opioids.

Despite the increase in medical need, doctors are not writing as many prescriptions for opioids as they used to, in part because they fear investigations for “overprescribing” by the DEA and other law enforcement agencies. 

“Declining prescribing does not reflect declining need. It reflects restricted access, pharmacy shortages, and policies that have pushed patients off medically necessary treatment. These quota reductions will increase harm, not reduce it,” wrote a poster who preferred to be anonymous. 

“The current atmosphere of fear around prescribing of opioids is very likely to account for the apparent reduction in use. If doctors are afraid to prescribe these medications, that leads to a decrease in prescriptions,” wrote Jonathan Rogers. “This situation has led to chronic pain patients seeking other treatment, including kratom, methadone from clinics that are set up for addiction treatment and not pain management, and adulterated street opioids.”

“Please STOP reducing the amount of opioids. Pain patients are suffering & your actions - continuing to reduce opioid production year after year - is fueling the dangerous black market & putting Americans who are desperate for pain relief at great risk. It’s irresponsible & speaks to your motives,” wrote an anonymous poster.

“Do not reduce the production of opioids. They are a necessary medication to treat patients. The previous reductions, laws, lawsuits by anti-opioid persons, and incarcerations of medical providers is already causing so much suffering and death of pain patients,” said another anonymous poster. 

“This insanity with cutting back and ultimately doing away with opioids is criminal,” wrote Brooke Moon. “Please allow doctors to practice medicine and prescribe what they deem is necessary for the treatment of pain. The suffering of millions of innocent pain patients doesn't need to continue. Please stop this insanity!”

Missed Deadlines

Several posters pointed out the DEA has repeatedly missed a December 1 deadline in the Controlled Substances Act for setting annual production quotas. That puts a strain on drug manufacturers and contributes to shortages. 

“My mother recently died of cancer and was unable to get her pain medication and died in agony. That is on you,” wrote Peter Wilson, who suffers from chronic back pain.

“You need to get your annual quotas for medications before the deadlines expire. You need to do your job and make sure there are adequate quotas of legitimate pain medication for patients who desperately need it. Don't blame this on the pharmaceutical companies whose hands are tied by your inability to come up with reasonable quotas in the allotted time.”

Other posters support a proposal for the DEA to hire a Chief Pharmacy Officer (CPO) and put that person in charge of quota allotments. A CPO would be more familiar with the drug supply system and manufacturing deadlines.

“They should have a CPO because the DEA and DOJ can't seem to stay on track by themselves. They are allowed to miss the deadline, but in a normal person's world, you would be reprimanded for missing the deadline,” said an anonymous poster.

“The DEA definitely needs to hire a Chief Pharmacy Officer to take control of the quota disaster. DEA cites lack of staffing as one of the reasons it can not get the next year's quota in by December 1. Hiring a CPO would assure that the quotas are in by the deadline and that someone knowledgeable would make an informed, reasonable decision on the amounts,” wrote another anonymous poster. 

Even with a shortened public comment period, the production quotas for 2026 will likely not be finalized until after January 1. The last time production quotas were that late was in 2024, when the quotas were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including opioid pain medications covered under the quota system.

DEA Missed Deadline for Opioid Production Quotas. Will It Worsen Shortages?

By Pat Anson

In recent years, hundreds of physicians have been prosecuted by the U.S. Justice Department for violations of the Controlled Substances Act (CSA).

In many cases, the doctors were accused of prescribing opioid pain medication without “a legitimate medical purpose” – a vague term in the CSA that was meant to prevent drug abuse, but in practice put the DOJ in charge of deciding whether healthcare decisions involving controlled substances are legal. 

The CSA is rigidly enforced when federal prosecutors believe opioids are prescribed excessively. But when it comes to enforcing another provision in the CSA, the DOJ and Drug Enforcement Administration have routinely ignored deadlines for setting aggregate production quotas (APQs) for opioids and other Schedule I and II controlled substances:

“On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II.”

The December 1 deadline is important because it gives the pharmaceutical industry a small window to prepare for the coming year by acquiring raw materials for drugs, setting manufacturing schedules, and distributing medications to hospitals and pharmacies – a process that can take as long as six months. . 

But Attorney General Pam Bondi and acting DEA Administrator Terry Cole didn't publish their proposed quotas for 2026 in the Federal Register until November 28, which call for a 6% cut in the supply of oxycodone.

Allowing for a shortened public comment period that ends December 15, and time to review thousands of comments and make changes in the quota allotments, that means the final APQs for next year will likely not be ready until after January 1.

The last time production quotas were that late was in 2024, when the final APQs were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including many medications that are covered under the quota system. 

Missing the deadline again this year threatens to worsen chronic shortages of oxycodone, hydrocodone, fentanyl, hydromorphone, morphine and amphetamine-based stimulants that are vital to millions of patients who live with pain or attention deficit disorder (ADHD).

The DOJ and DEA did not respond to multiple requests from PNN to explain why the CSA deadline was missed again.

This is not a new problem. Late quotas and drug shortages have persisted for years, as the DOJ and DEA have focused on going after doctors who prescribe opioids – at times using “flimsy evidence” – rather than ensuring that essential medications are available on time. 

That mindset of being a law enforcement agency first – with maintaining the drug supply an afterthought – may have cost some patients their lives. 

“We talk a lot about opioid misuse, but almost never about the quiet suffering caused when essential pain medicines simply aren't available,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Chronic delay and rigidity in quota decisions make patients with serious illness feel like collateral damage in a war on drugs that has lost sight of its humanitarian obligations.

“Quotas were meant to curb diversion, not to create a permanent state of scarcity for people in pain. By keeping quotas tight and decisions late, the DEA has turned an already fragile supply chain into a game of musical chairs where patients lose their seats.”

Late Quotas Worsened Drug Shortages

As far back as 2015, the General Accountability Office (GAO) warned in an audit report that the DEA “has not effectively administered the quota process.” Although a decade old, many of the problems cited by the GAO still exist today.

“Each year, manufacturers apply to DEA for quota needed to make their drugs. DEA, however, has not responded to them within the time frames required by its regulations for any year from 2001 through 2014,” the GAO said.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs.”

The report found that drugs containing Schedule II controlled substances accounted for over half the shortages between 2001 and 2013. Several manufacturers complained to the FDA the shortages were caused by the DEA’s mishandling of the quota system.

But the DEA denied any responsibility for the shortages, while blaming the missed deadlines on  “inadequate staffing” and an “increasing workload” in its Quota Unit.

“DEA is confident that its administration of the quota process did not affect a shortage during the period of review because drug product shortages are not limited to products that contain Schedule II controlled. substances,” Joseph Rannazzisi, then-DEA Deputy Assistant Administrator, wrote in the agency’s response to the GAO report.

Rannazzisi would later emerge as a “whistleblower” on 60 Minutes, who blamed the opioid crisis on lax policies at the FDA that favored that drug industry.

The relationship between DEA and FDA, at least in 2015, was not one of trust. The FDA advised the DEA about medical demand for Schedule II drugs and any shortages that may exist, but the DEA didn’t always listen.

“DEA and FDA are not able to effectively collaborate due to fundamental disagreement over whether any given shortage exists. DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the GAO said. “They do not believe FDA appropriately validates or investigates the shortages.” 

The GAO concluded that problems in DEA’s Quota Unit run deeper than any petty rivalries with the FDA. 

“Our work shows that DEA’s lack of internal controls, such as controls to ensure data reliability, performance measures, and monitoring of performance, may hinder the agency’s ability to ensure an adequate and uninterrupted supply of controlled substances,” the 2015 report found. “This approach to the management of an important process is untenable and poses a risk to public health.”

New Deadline

The GAO’s critique came at a time when the DEA’s deadline for final APQs was October 1 – a deadline the agency consistently failed to meet. 

To buy itself more time to work on quotas, the DEA lobbied Congress to change the annual deadline to December 1 in the 2018 Support Act, a bill intended to reduce opioid diversion. The DEA also reduced the amount of inventory drug manufacturers are allowed to keep of controlled substances, and agreed to base its quotas on dosages, not the raw supply of drugs.

How has that worked out? Poorly.

The DEA has not only been unable to meet the December 1 deadline, but the smaller inventories have worsened the ability of drug manufacturers to respond to late quotas and emerging drug shortages. 

The pharmaceutical industry warned the DEA that reducing inventories would only worsen shortages and do little to prevent diversion.

“We believe that risks associated with this proposal, including the increased likelihood for drug shortages and market outages, greatly outweigh the negligible benefit this provision will provide,” Larry Cote, an attorney representing a drug manufacturer, wrote to the agency in 2019.

“Given the timing of procurement quota issuance, it will become more imperative to carry increased levels of inventory at year end in order to ensure continued drug supply, as opposed to decreased levels.”

The DEA ignored those warnings and reduced inventories anyway. As a result, analgesic medications needed for surgery and post-op care, such as injectable fentanyl and hydromorphone, have been on the FDA shortage list for years, in part due to low inventories. The two drugs are rarely diverted.

‘Vulnerable to Supply Shocks’

Two pharmacists recently criticized the DEA for its “outdated system” for APQs.

“The current one-size-fits-all system for setting APQs is ineffective and Congress recognized this back in 2018, passing the SUPPORT Act to modernize the APQ setting process and require quota allocations based on dosage form. Yet seven years later, the DEA has failed to implement this law, leaving manufacturers constrained, patients underserved, and the nation vulnerable to supply shocks,” Soumi Saha, PharmD, and Justin Schneider, PharmD, wrote in a recent op/ed published in the Pharmacy Times.   

Saha and Schneider believe many of the quota problems could be addressed if the DEA were to hire a Chief Pharmacy Officer who is familiar with the drug supply system and is put in charge of the quota system.

“It is time to elevate the agency’s clinical responsibility by establishing a Chief Pharmacy Officer (CPO) within the DEA - a role dedicated to ensuring that patient access is not an afterthought, but a core priority,” they said. “A strong CPO would not only modernize quota systems but also bring agility, accountability and patient advocacy to the heart of DEA decision-making.”

To be clear, the DEA is not solely at fault for persistent shortages of opioids and other controlled substances. A 2021 opioid litigation settlement with three drug distributors essentially rationed the supply of opioids at many pharmacies and made pharmacists even more wary of filling new prescriptions. 

In a 2023 PNN survey of over 2,800 patients, 90% said they experienced delays or problems getting their opioid prescriptions filled, mostly because their pharmacy was out of stock. Nearly one in five were unable to get their pain medication, even after contacting multiple pharmacies.

Some generic drug manufacturers have stopped making opioids because of low profit margins and because of concerns they could be targeted by plaintiff law firms in opioid lawsuits that could cost them billions of dollars. 

Bad weather and a heavy reliance on foreign drug manufacturers have also made the supply chain less reliable and contributed to shortages.  

But the DEA’s chronic failure to meet quota deadlines – a problem dating back decades – and its slow-walking of efforts at reforming the quota system, have made a fragile drug supply chain even more vulnerable to disruptions. And it is patients who pay the ultimate price for the DEA’s negligence.

“When DEA repeatedly misses its own deadlines for setting opioid production quotas, that uncertainty reverberates all the way to the bedside,” says Dr. Webster. “Manufacturers pull back, pharmacies ration, and it's the patients – people with cancer, sickle cell disease, or severe chronic pain – who are left wondering if their next prescription will even be filled.” 

Should the DEA hire a Chief Pharmacy Officer? Should deciding what is or isn’t “a legitimate medical purpose” be left to the DEA and DOJ? Only a few days are left to comment on the DEA’s proposed APQs for 2026. You can leave a public comment by clicking here.

Gabapentin’s Side Effects May Lead to ‘Prescribing Cascade’

By Pat Anson

Over the years, we’ve published many warnings about gabapentin (Neurontin), a nerve medication that is widely prescribed off-label for pain conditions it was never intended to treat. 

Common side effects from gabapentin include brain fog, dizziness, weight gain, headache, fatigue, and anxiety. The drug has also been linked to a higher risk of dementia.

According to a new study, those side effects may lead to a “prescribing cascade” in which physicians mistakenly prescribe unnecessary medications to a patient that cause even more side effects. 

The problem is not limited to gabapentin, but includes other nerve medications such as pregabalin (Lyrica), which are collectively known as gabapentinoids. Both medications may cause edema – fluid retention and swelling in the legs and feet –  leading doctors to suspect congestive heart failure and prescribe diuretics that can cause kidney injury, light headedness, and falls. 

Researchers with the VA Health Care System and the University of California, San Francisco (UCSF) analyzed the medical records of 120 older veterans, most of whom were male and long-term users of five or more medications. All had taken gabapentinoids and diuretics, which are often prescribed for edema.  

Although none of the veterans had fluid buildup in the year before they started taking gabapentinoids, only 4 doctors suspected the drugs were the culprit and just one discontinued the medication.

The vast majority of physicians – 69 in all – never suspected or downplayed the possibility that gabapentinoids may be causing the edema. Since fluid retention is a symptom of congestive heart failure and poor blood circulation, the veterans were put on loop diuretics such as Lasix.

Within two months, 28 veterans had side effects from the new drugs, including poor kidney function, dizziness, and blurred vision, along with low levels of sodium or potassium, which can disrupt critical body functions. Six patients had symptoms so severe they were hospitalized or taken to an emergency department. 

“Gabapentinoids may be prescribed at unnecessarily high doses or for conditions that they may not help,” said Matthew Growdon, MD, an Assistant Professor of Medicine at UCSF and first author of the study in JAMA Network Open. “In these cases, doctors should consider not prescribing these drugs — or giving lower doses to lessen the risk of prescribing cascades and other side effects.” 

One veteran in his 60’s was put on a heavy dose of gabapentin for neuropathy that was induced by chemotherapy for lung cancer. He developed edema and was switched to pregabalin. When the fluid retention didn’t stop, he was put on a diuretic. Within two days he developed light headedness and felt off-balance, and the diuretic was stopped.

Another patient in his 60’s was prescribed gabapentin twice a day for back pain, an off-label use. After two months he had edema and was put on a diuretic. Soon after, he experienced a fall, went to the ER, and was given IV pain medication. The diuretic and polypharmacy are believed to have contributed to the man falling.

The cases highlight how a prescribing cascade with multiple drugs can have serious health consequences. Patients on gabapentinoids may be prescribed sleep aids, anti-depressants and other medications to counteract the drugs’ many side effects.

Gabapentin is often prescribed off-label for migraine, fibromyalgia, cancer pain, postoperative pain, and many other pain conditions for which it is not FDA-approved. Off-label prescribing is legal and sometimes appropriate, but has reached extreme levels for gabapentin. Studies estimate the drug is prescribed off-label up to 95% of the time

“Gabapentinoids are non-opioids, and prescribers associate them with a relatively favorable safety profile,” says senior author Michael Steinman, MD, a Professor of Medicine at UCSF.  “Patients taking them should regularly check in with their doctor to assess whether this is the best treatment for them and consider other options, including non-drug alternatives that might be more appropriate.” 

In 2024, gabapentin was the fifth most prescribed drug in the U.S., with prescriptions nearly tripling since 2010. The number of patients prescribed gabapentin reached 15.5 million in 2024, up from 5.8 million in 2010.