7-OH Is a Breakthrough for Pain Relief and Should Remain Legal

By Crystal Lindell 

This week, in a very disappointing move, Missouri took a step towards banning most 7-OH products, joining a long list of governmental bodies considering similar things. 

If you’re unfamiliar, 7-OH is an alkaloid that occurs naturally in kratom, the full name of which is 7-hydroxymitragynine. When concentrated, it has opioid-like effects that can relieve pain and boost energy levels. 

The interesting part is that 7-OH doesn’t cause respiratory depression the way opioids do, which means it is not deadly the way opioids can be. 

Unfortunately, multiple governmental bodies are attempting to ban it. While the FDA would like to ban it nationwide, states like Florida, Ohio and Kentucky have already banned it, while health officials in California are taking it off store shelves.

The Missouri Senate is considering a bill that would also effectively ban 7-OH. The proposed law would prohibit the sale of all kratom products to people under the age of 21 and specifically limit the 7-OH content in products to 2%.

Since many contain about 50% 7-OH or, in some cases, substantially more, that would essentially prohibit the sale of all 7-OH products. Violators could face felony charges if the bill becomes law.

The Missouri Independent reported that during a committee hearing about the bill, State Sen. Maggie Nurrenbern (D) of Kansas City said several families submitted statements calling 7-OH products “highly addictive, unregulated drugs” that have impacted their loved ones and children.

“I don’t know if there’s any more pressing issue before us than making sure that kids don’t have access to these drugs,” Nurrenbern told the committee. “As well as making sure that we’re not doing further damage to our community right now that’s already grappling with so much in terms of addiction and mental health.” 

A Painkiller That Actually Works

It’s disheartening to see 7-OH framed this way, when I know just how much value it has for the lives of the millions of people suffering from chronic pain. 

For years, we’ve been told that the reason opioid prescriptions had to be greatly restricted was because of overdose deaths. But now that we finally have something that actually treats pain without directly causing OD deaths, officials are still trying to claim it is doing “damage” to the community. 

What about the damage caused by chronic pain?

My life is littered with hellish stories about people I know who couldn’t get pain meds when they needed them. In fact, comment sections on PNN’s social media are often overflowing with the same type of stories.

Readers tell us many doctors dismiss their pain, refuse to prescribe opioid medication, and leave patients to suffer. Some pharmacists also refuse to fill opioid prescriptions and get irate when pushed. 

I have even seen numerous patients lamenting that they have lost the will to live because their severe pain is untreated. I have been there myself. Before I found my current doctor — who prescribes me enough pain medication to function — I still remember talking to my mom about how, if I do kill myself, I want her to understand that death would be a mercy for me.

But now there is an over the counter substance that actually treats pain, and I just have to call it what it feels like to me as a patient: a miracle.

In fact, I would argue that  7-OH is likely the closest we will come in my lifetime to seeing something like hydrocodone being sold OTC – something I have long advocated for.

In a humane society, everyone should have access to effective pain treatment, especially in a country without universal healthcare or insurance coverage.  

I was talking to my fiancé about a surgery he had a few years ago, where the operating surgeon initially refused to give him opioid medication for post-operative pain. The doctor claimed that his other patients had only needed ibuprofen — after he took a scalpel and sliced open their arms to repair a nerve. 

While my partner was still coming out of anesthesia, I had to argue with his surgeon to make sure he was sent home with at least a handful of Norco. 

I had made the mistake in the past of not doing this after my partner’s nose surgery, and then I was left to watch him suffer on the couch for three days while he lamented that every time he tried to breathe, it felt like death.

If either situation happened today, we could save ourselves from so much stress and agony because he could just take 7-OH post-op. Yes, 7-OH is that good of a painkiller.

If doctors were smart they would be jumping all over 7-OH. Finally, something that actually relieves pain and doesn’t kill their patients.  It’s what we have all been looking for! 

But no, doctors are not recommending 7-OH. In fact, most have never heard of it, while state and local governments either ban it or threaten to do so. 

Yes, there are some downsides. The main one being just how expensive it is. One 7-OH chewable tablet, which has 4 servings, will run you around $10. 

It can also be difficult to figure out which brand works best for you, in large part because there’s so little regulation of kratom or 7-OH, making it difficult to know what each brand puts into their tablets and how much is in there.

My circle of people really liked using the brand 7Stax, but you can also browse through the r/7_hydroxymitragynine subreddit for additional recommendations and user experiences. 

You should know that 7-OH can cause dependence and withdrawal symptoms if you abruptly stop taking it. As someone who has used opioids for over a decade to manage pain, I am an expert on tapering down medications to avoid withdrawal. Newcomers may have some trial and error time before they figure out what’s best for their own bodies.

There’s also not much research on how 7-OH interacts with other drugs or health conditions, not to mention the lack of information about long-term side effects.

That is largely why I am still hesitant to recommend it to elderly relatives, as their health tends to be more fragile. Although, paradoxically, they also tend to be much more likely to have chronic pain.  

With everything going on in the news, it does seem like the fight to make 7-OH illegal has taken a backseat to other issues.  

What I would say is that if you have been hesitant to try 7-OH because you don’t want to waste money on another BS supplement that probably won’t work, then I can vouch for the fact that it does work on my pain. 

I’m not a doctor, just a patient who also has a lot of loved ones with chronic pain. And I can tell you that everyone I know who tries 7-OH finds it to be effective.  

If you are among those who have already found 7-OH to be effective, I encourage you to be proactive by reaching out to your local government officials to tell them how important it is for you. I would also encourage you to make yourself available to local reporters when possible, so that they can offer balanced coverage of 7-OH. 

While 7-OH is a breakthrough, it will only stay that way if it remains legal. We all have to fight to keep it that way. 

From Reefer Madness to Schedule III: What I Learned About Marijuana

By Carol Levy

I was a child of the late 60's and early 70's. I gave daisies to policemen as I walked by them. My friends called me a “hippie dippy.”

In a way, I was. I protested against the Vietnam war. I sat in the park with friends and sang folk songs. One of the boys wore love beads. I wore a headband.

I never did try any of the psychotropic drugs that were easily obtained at that time. Illegal, yes, but very available. Marijuana seemed to be the one most easily gotten.

Since my trigeminal neuralgia pain started in 1976, doctors prescribed me with most of the opioids that were available, including tincture of opium, morphine, oxycodone, fentanyl, codeine, Demerol, Darvon, and even methadone.

I had the same reaction to all of them. I felt groggy, cotton-headed, and dry-mouthed – and they didn't help my pain at all. 

Google “How do opioids make you feel?” and you’ll get answers like, “Opioids make you feel calm, relaxed, and euphoric by blocking pain signals and activating pleasure centers in the brain."

None of which I found to be true.

The stories about marijuana made me nervous. My friends said it makes you high and gives you the munchies. 

Google “How does marijuana make you feel?” and you’ll be told it causes “feelings of euphoria, deep relaxation, intensified sensory experiences, and altered time perception.”

All of which I was afraid was true!

I like to be tied to reality. My fear was that marijuana would make me feel as though reality had left me, as the “Reefer Madness” movie said it would. This was a drug I would never try.

But then medical marijuana became legal in my state of Pennsylvania. Despite the pain and no benefit from any opioid, I wasn't sure I wanted to try it. 

To be honest, as much as none of the opioids scared me, marijuana did. I wasn't sure how it would make me feel.

Most of us know the quiet desperation of poorly treated pain: “I'll try anything to stop the pain.” That is how I felt about marijuana. Fearful or not, maybe, just maybe, it will help. And, I had reason to believe it might.

Despite marijuana being an illegal Schedule I controlled substance with “high abuse potential and no accepted medical use,” limited research was permitted under strict FDA and DEA regulations. Marijuana may soon be rescheduled as a legal Schedule III substance, although its future use in medicine is still an open question.

Over the years, I have seen research that showed marijuana helped those with anaesthesia dolorosa (phantom pain), which is the pain and numbness many amputees feel after a limb is removed. I have anaesthesia dolorosa on one side of my face, a side effect of surgery. 

If marijuana helped them, would it help me?

I signed up for Pennsylvania’s medical marijuana program. The next step was to find a doctor, authorized by the state, to certify that I met the requirements for certification, which meant having one or more of the disorders on a list of allowable health conditions. Once I was certified, I was free to go to a dispensary and buy medical marijuana.

It may sound incredible today, but when I got my first prescription for opium – way back when – the pharmacist immediately filled it for me. The same was true for all the other opioid prescriptions I was given. If I had questions, the pharmacist could answer them.

I expected the same would be true for marijuana.

The dispensary had security, that was not a surprise. I had to show my state certification card to get inside the building. Then I sat in a waiting room, filled with others waiting their turn. 

After a few minutes, someone came out of the office, and called my name. We went to a room with a counter and 5 or 6 stations where you would select the marijuana you would buy. 

I knew nothing about how marijuana worked, what kind I should try, or how much I needed. There was no prescription setting the dose or how often I should take it. No doctor told me what to get or the CBD and THC combination I should try. The salespeople could not answer my questions about dosage, effects, or how long it would stay in my system. 

I am glad so many of us are now able to try marijuana, a drug that carries fewer consequences than some of the higher-level opioids I used to get. 

But I hate that no one can tell me the important points: how much, how often, etc. When I first tried marijuana, it didn't help. The two pain doctors I saw told me I wasn’t taking enough. But they couldn't tell me how much is “enough.”

Marijuana is a wonderful addition, finally, to the list of drugs we are allowed to have. I am happy I have the option. But I am very unhappy that it is still not seen as a medical medication. It’s more of a “what the heck, give it a try” substance.

Maybe marijuana can be another tool that doctors have in their arsenal for chronic pain. Maybe getting it off Schedule I and putting it into Schedule III will let the research start in earnest, and it will then become a real medication your doctor can prescribe with specific instructions on the type, combination, and dosage. 

I look forward to the day you can get marijuana from a pharmacist, instead of an untrained salesperson in a dispensary

Fed Vaccine Policies Ignore Covid’s Long-Term Harm

By Stephanie Armour, KFF Health News

Possible risk of autism in children. Dormant cancer cells awakening. Accelerating aging of the brain.

Federal officials in May 2023 declared an end to the national covid pandemic. But more than two years later, a growing body of research continues to reveal information about the virus and its ability to cause harm long after initial infections resolve, even in some cases when symptoms were mild.

The discoveries raise fresh concerns about the Trump administration’s covid policies, researchers say. While some studies show covid vaccine offer protective benefits against longer-term health effects, the Department of Health and Human Services has drastically limited recommendations about who should get the shot. The administration also halted Biden-era contracts aimed at developing more protective covid vaccines.

The federal government is curtailing such efforts just as researchers call for more funding and, in some cases, long-term monitoring of people previously infected.

“People forget, but the legacy of covid is going to be long, and we are going to be learning about the chronic effects of the virus for some time to come,” said Michael Osterholm, an epidemiologist who directs the University of Minnesota’s Center for Infectious Disease Research and Policy.

The Trump administration said that the covid vaccine remains available and that individuals are encouraged to talk with their health providers about what is best for them. The covid vaccine and others on the schedule of the Centers for Disease Control and Prevention remain covered by insurance so that individuals don’t need to pay out-of-pocket, officials said.

“Updating CDC guidance and expanding shared clinical decision-making restores informed consent, centers parents and clinicians, and discourages ‘one size fits all’ policies,” said HHS spokesperson Emily Hilliard.

Although covid has become less deadly, because of population immunization and mutations making the virus less severe, researchers say the politicization around the infection is obscuring what science is increasingly confirming: covid’s potential to cause unexpected, possibly chronic health issues. That in turn, these scientists say, drives the need for more, rather than less, research, because over the long term, covid could have significant economic and societal implications, such as higher health care costs and more demands on social programs and caregivers.

The annual average burden of the disease’s long-term health effects is estimated at $1 trillion globally and $9,000 per patient in the U.S., according to a report published in November in the journal NPJ Primary Care Respiratory Medicine. In this country, the annual lost earnings are estimated to be about $170 billion.

One study estimates that the flu resulted in $16 billion in direct health costs and $13 billion in productivity losses in the 2023-2024 season, according to a Dec. 30 report in medRxiv, an online platform that publishes work not yet certified by peer review.

Covid’s Growing Reach

Much has been learned about covid since the virus emerged in 2019, unleashing a pandemic that the World Health Organization reports has killed more than 7 million people. By the spring of 2020, the term “long covid” had been coined to describe chronic health problems that can persist post-infection.

More recent studies show that infection by the virus that causes covid, SARS-CoV-2, can result in heightened health risks months to more than a year later.

For example, researchers following children born to mothers who contracted the virus while pregnant have discovered they may have an increased risk for autism, delayed speech and motor development, or other neurodevelopmental challenges.

Another study found babies exposed to covid in utero experienced accelerated weight gain in their first year, a possible harbinger of metabolic issues that could later carry an increased risk for cardiovascular disease.

These studies suggest avoiding severe covid in pregnancy may reduce risk not just during pregnancy but for future generations. That may be another good reason to get vaccinated when pregnant.

“There are other body symptoms apart from the developing fetal brain that also may be impacted,” said Andrea Edlow, an associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School who was involved in both studies. “We definitely need more research.”

Epidemiologists point to some specific, emerging challenges.

A U.K. study in The New England Journal of Medicine found people who fully recovered from mild covid infections experienced a cognitive deficit equal to a three-point drop in IQ. Among the more than 100,000 participants, deficits were greater in people who had persistent symptoms and reached the equivalent of a nine-point IQ drop for individuals admitted to intensive care.

Ziyad Al-Aly, a clinical epidemiologist who has studied longer-term health effects from covid, did the math. He estimated covid may have increased the number of adults in the U.S. with an IQ of less than 70 from 4.7 million to 7.5 million — a jump of 2.8 million adults dealing with “a level of cognitive impairment that requires significant societal support,” he wrote.

“People get covid-19, some people do fine and bounce back, but there are people who start experiencing problems with memory, cognition, and fuzzy brain,” he said. “Even people with mild symptoms. They might not even be aware.”

Diane Yormark, 67, of Boca Raton, Florida, can relate. She got covid in 2022 and 2023. The second infection left her with brain fog and fatigue.

“I felt like if you had a little bit too much wine the night before and you’re out of it,” said Yormark, a retired copywriter, who said the worst of her symptoms lasted for about three months after the infection. “Some of the fog has lifted. But do I feel like myself? Not like I was.”

Data from more than a dozen studies suggests covid vaccines can help reduce risk of severe infection as well as longer-lasting health effects, although researchers say more study is needed.

But vaccination rates remain low in the U.S., with only about 17% of the adult population reporting that they got the updated 2025-2026 shot as of Jan. 16, based on CDC data.

Trump administration officials led by Health and Human Services Secretary Robert F. Kennedy Jr. have reduced access to covid vaccines despite the lack of any new, substantiated evidence of harm. Though the shots were a hallmark achievement of the first Trump administration, which led the effort for their development, Kennedy has said without evidence that they are “the deadliest vaccine ever made.”

In May he said on X that the CDC would stop recommending covid shots for healthy children and pregnant women, citing a lack of clinical data. The Food and Drug Administration has since issued new guidelines limiting the vaccine to people 65 or older and individuals 6 months or older with at least one risk factor, though many states continue to make them more widely available.

The Trump administration also halted almost $500 million in funding for mRNA-based vaccines. Administration officials and a number of Republicans question the safety of the Nobel Prize-winning technology — heralded for the potential to treat many diseases beyond covid — even though clinical trials with tens of thousands of volunteers were performed before the covid mRNA vaccines were made available to the public.

And numerous studies, including new research in 2025, show covid vaccine benefits include a reduction in the severity of disease, although the protective effects wane over time.

‘We Don’t Know What Will Happen to People’

Researchers say more and broader support is important because much remains unknown about covid and its impact on the body.

The growing awareness that, even in mild covid cases, the possibility exists for longer-term, often undetected organ damage also warrants more examination, researchers say. A study published this month in eBioMedicine found people with neurocognitive issues such as changes in smell or headaches after infection had significant levels of a protein linked to Alzheimer’s in their blood plasma. EBioMedicine is a peer-reviewed, open-access journal published by The Lancet.

In the brain, the virus leads to an immune response that triggers inflammation, can damage brain cells, and can even shrink brain volume, according to research on imaging studies that was published in March 2022 in the journal Nature.

An Australian study of advanced brain images found significant alterations even among people who had already recovered from mild infections — a possible explanation for cognitive deficits that may persist for years. Lead study author Kiran Thapaliya said the research suggests the virus “may leave a silent, lasting effect on brain health.”

Al-Alay agreed.

“We don’t know what will happen to people 10 years down the road,” he said. “Inflammation of the brain is not a good thing. It’s absolutely not a good thing.”

That inflammatory response has also been linked to blood clots, arrhythmias, and higher risk of cardiovascular issues, even following a mild infection.

A University of Southern California study published in October 2024 in the journal Arteriosclerosis, Thrombosis, and Vascular Biology found the risk for a major cardiac event remains elevated nearly three years after covid infection. The findings held even for people who were not hospitalized.

“We were surprised to see the effects that far out” regardless of individual heart disease history, said James R. Hilser, the study’s lead author and a postdoctoral fellow at the UCLA David Geffen School of Medicine.

Covid can also reactivate cancer cells and trigger a relapse, according to research published in July in the journal Nature. Researchers found that the chance of dying from cancer among cancer survivors was higher among people who’d had covid, especially in the year after being infected. There was nearly a twofold increase in cancer mortality in those who tested positive compared with those who tested negative.

The potential of the covid virus to affect future generations is yielding new findings as well. Australian researchers looked at male mice and found that those who had been infected with and then recovered from covid experienced changes to their sperm that altered their offspring’s behavior, causing them to exhibit more anxiety.

Meanwhile, many people are now living — and struggling — with the virus’ after-effects.

Dee Farrand, 57, of Marana, Arizona, could once run five miles and was excelling at her job in sales. She recovered from a covid infection in May 2021.

Two months later, her heart began to beat irregularly. Farrand underwent a battery of tests at a hospital. Ultimately, the condition became so severe she had to go on supplemental oxygen for two years.

Her cognitive abilities declined so severely she couldn’t read, because she’d forget the first sentence after reading the second. She also had to leave herself reminders that she is allergic to shrimp or that she likes avocados. She said she lost her job and returned to her previous occupation as a social worker.

“I was the person who is like the Energizer bunny and all of a sudden I’d get so tired getting dressed that I had to go back to bed,” Farrand said.

While she is better, covid has left a mark. She said she’s not yet able to run the five miles she used to do without any problems.

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

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 from patients undergoing SUD treatment in all 50 U.S. states.   

Over the past decade, gabapentin (Neurontin) prescribing nearly doubled, from 3.9% of patients undergoing addiction treatment 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. 

Injectable Gel May Be Long Term Solution to Chronic Low Back Pain

By Pat Anson

An experimental hydrogel continues to show promise as a long-term treatment for chronic low back pain caused by degenerative disc disease.

Findings from a feasibility study, recently published in the the journal Pain Physician, show that 60 patients with low back pain had significant improvements in physical function, low back pain, and low leg pain a year after Hydrafil gel was injected into their damaged discs.

The gel is heated to liquify it before being injected into cracks and tears in discs. It hardens as it cools, restoring the discs’ structural integrity. The procedure takes about 30 minutes and can be performed as an outpatient procedure under local anesthesia. 

Unlike other cement-like material injected into damaged discs to restore stability, the gel remains flexible and mimics the biomechanical properties of the natural disc, preserving spinal motion. 

Most patients showed significant improvement in their pain and disability scores within one month, and the results were maintained 12 months later. 

“These peer-reviewed results represent an important milestone in the development of the first nucleus augmentation technology for degenerative disc disease,” said Douglas Beall, MD, Chief of Radiology Services at Clinical Radiology of Oklahoma and a medical advisor to ReGelTec, which developed the Hydrafil system. 

“The improvements in pain and function observed at one year, along with an acceptable safety profile, support the continued evaluation of the HYDRAFIL System in the ongoing pivotal study designed to support FDA approval of the device for patients who currently have limited minimally invasive treatment options.”

Five of the 60 patients had increased back and leg pain or numbness, due to the gel partially migrating beyond the injection site. The migrated gel was later removed.

This promotional video by ReGelTec demonstrates how the Hydrafil system works:

ReGelTec is currently recruiting 225 patients in the U.S. and Canada for a new study to assess the Hydrafil system, an important step towards getting FDA approval. 

Hydrafil received the FDA’s breakthrough device designation in 2020, which allows for an expedited review of an experimental product when there is evidence it is more effective than current options.  

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, supporting movement and flexibility. But with aging and activity, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.

Current treatments for degenerative discs include physical therapy, anti-inflammatory medication, and analgesics. When those are insufficient, epidural steroid injections and surgical options such as a disc removal or spinal fusion may be considered.

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.

How Stress Makes Pain Worse

By Crystal Lindell

One of the easiest ways to spot a true chronic pain veteran is that they will be eerily silent during the worst pain of their lives.

That’s because people who endure pain day-in and day-out quickly learn that the worst thing you can do during a pain flare is panic and scream.

In practice, those things only serve to increase your stress levels, which will also increase your pain. The best response to pain is to keep yourself as calm and as quiet as possible.

I did not know this in the beginning. Back when I first started having chronic pain a little over a decade ago, the pain itself would stress me out. I’d end up in a devastating cycle where the pain increased, which made my stress increase, which made my pain increase. Usually, the only way to break the cycle would be to go to the emergency room.

A new study, published in the journal PAIN, offers some data proving this phenomenon. Belgian scientists found that stress heightens acute pain caused by electrical stimulation to the skin, and increases sensitivity to pinpricks.

While pinpricks and electrical stimulation are a far cry from the type of pain most chronic pain sufferers endure, it is still interesting to see data proving what many patients have already figured out: Stress makes pain worse.

The study was conducted on healthy women, using two different experiments. To measure their pain response, participants were asked to rank their pain on a scale of 0-100. 

To induce stress, researchers used the Mannheim Multicomponent Stress Test (MMST), a computer program that causes stress with difficult cognitive tests or disturbing noises and images.

In the first experiment, the researchers induced stress before they started administering electrical stimulation. They followed that up with pinpricks. 

They found that participants ranked their pain after the initial pinpricks as being 10 points higher. But pain decreased back to the normal range as they kept administering the pinpricks.

In the second experiment, stress was induced 20 minutes after they started administering electrical stimulation. They found that pinprick hypersensitivity significantly increased after the stress was induced.

In other words, if someone is stressed before electrical stimulation, it can make that stimulation hurt more. But it doesn't impact whether or not they become more sensitive to pinpricks. 

However, when someone becomes stressed after the electrical stimulation, the stress makes the sensitivity to pinpricks worse. 

While I still hate when people suggest yoga as a treatment for my chronic pain, I will admit that learning to keep myself calm during a flare can go a long way. And research like this helps prove why serenity is so important for pain patients. 

‘No Clear Evidence’ Medical Cannabis Helps With Neuropathic Pain

By Crystal Lindell

A new multi-study analysis is further muddying the water on whether medical cannabis is an effective treatment for neuropathic pain.

The Cochrane review – considered the gold standard in medical research – looked at results from 21 high-quality clinical studies of medical cannabis involving nearly 2,200 participants. German researchers were hoping to find whether THC and/or CBD helped people suffering from neuropathic pain.

They found “no clear evidence” that THC‐dominant medicines, CBD-dominant medicines or THC/CBD‐balanced medicines provided pain relief of 50% or more compared to a placebo. A 50% reduction in pain is generally considered an effective response rate for pain medication.

The new findings contradict a recent U.S. study that found THC more effective in relieving pain than CBD. That review mostly involved patients with chronic neuropathic pain.

The findings also contradict a recent survey of 1,450 medical cannabis users, which found that cannabis works best on neuropathic pain, such as pain caused by diabetic neuropathy, post-herpetic neuralgia, and multiple sclerosis.

As someone with nerve pain in my ribs, these contradictory results are not surprising. I’ve tried both THC and CBD and found them lacking. The most effective class of medications for me remains opioids, with 7-OH a close second.

I fully believe that people should have access to whatever medications work best for them. So, if there are people out there who find that THC works best to alleviate their nerve pain, then by all means they should be allowed to take it. And of course, this new research shouldn’t negate the idea that many people do find cannabis to be very effective at treating other conditions.

The issue is that over the last decade, as cannabis legalization has spread, some doctors have recommended that their patients try medical cannabis, while refusing to prescribe opioids. That is a problem, especially when research shows that cannabis doesn’t work well for most people with nerve pain, and that THC comes with unwanted side effects.

The good news though is that as cannabis has gained more official legal status, research like this is actually happening. So, we can actually have real scientific data, rather than just anecdotal evidence about cannabis.

I’d also really like to see in-depth research about natural leaf kratom and kratom extracts like 7-OH. Perhaps if data showed them as being effective and with few side effects, governments would stop being so quick to ban them.

In the end, every person’s pain is uniquely theirs to endure, and which treatments work will vary from person to person. When doctors and regulators finally accept there is no one treatment that fits all, that we can truly make progress in alleviating pain.  

Scientists May Finally Know Why Statins Cause Muscle Pain

By Pat Anson

Many people stop taking cholesterol-lowering statins because they experience painful muscle cramps, weakness, and fatigue. I know, because I was one of them.

I started taking statins in my 40’s on the advice of our family physician, because of mildly elevated cholesterol and a family history of coronary artery disease. Soon I was having stinging cramps in my legs overnight, which were painful enough to wake me up. 

My doctor was skeptical that statins were the cause, but switched me from Lipitor to Vytorin and finally to Crestor. The muscle cramps continued. Only when I stopped taking statins did the symptoms disappear.

“I’ve had patients who’ve been prescribed statins, and they refused to take them because of the side effects. It’s the most common reason patients quit statins, and it’s a very real problem that needs a solution,” says Andrew Marks, MD, Professor and Chair of the Department of Physiology and Cellular Biophysics at Columbia University.

To find a solution, first you need to identify the cause, and Marks and his colleagues have finally discovered why about 10% of people on statins experience those muscular side effects.

Their research, recently published in The Journal of Clinical Investigation, found that a widely-used statin called simvastatin (Zocor) binds to a protein in muscle cells, which causes a leak of calcium ions inside the cells.

Using an electron microscope, researchers watched simvastatin molecules bind to two locations in a muscle protein called the ryanodine receptor, which opened a channel in the receptor that allowed calcium to flow through. 

Marks says the calcium leak could be weakening the muscle directly or by activating enzymes that degrade muscle tissue.

“It is unlikely that this explanation applies to everyone who experiences muscular side effects with statins, but even if it explains a small subset, that’s a lot of people we could help if we can resolve the issue,” Marks said in a press release.

The electron images suggest that statins could be redesigned so they don’t bind to the ryanodine receptor, but retain their cholesterol-lowering ability. 

Marks is now collaborating with chemists to create such a statin. He owns stock in RyCarma Therapeutics, a company developing compounds that target the ryanodine receptor.

Plugging the calcium leak could be another option: Statin-induced calcium leaks in laboratory mice can be closed with an experimental drug developed by Marks for other muscle conditions involving calcium leaks.

“These drugs are currently being tested in people with rare muscle diseases. If it shows efficacy in those patients, we can test it in statin-induced myopathies,” Marks says.

The first statin was approved by the FDA in 1987, but it took the agency nearly three decades to listen to patients like me and update warning labels on statins in 2014, cautioning that statins can cause myopathy. In rare instances, the FDA says statins can also cause liver injury, diabetes and memory loss.   

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.

There’s Still Plenty of Stigma About Opioid Addiction

By Crystal Lindell

Many Americans still view opioid addiction as a stigmatized condition – with over half (58%) saying they wouldn’t want someone with an opioid use disorder marrying into their family. And over a third (38%) don’t want to be neighbors with someone with opioid addiction.

That’s according to an online survey of over 1,550 U.S. adults by researchers at Cornell University, who published their findings in JAMA. 

The goal of the survey was to see how Americans view opioid overdose deaths, people with opioid addiction, and who is responsible for solving the opioid crisis. They also measured if views differed by political ideology.

Notably, the survey did not define “addiction” before asking questions about it, leaving it up to each respondent to rely on their own personal perception of what addiction is. There are issues with that approach, as many people don’t know the difference between addiction and dependence, which is a reliance on medication to treat a health condition.

The survey also didn’t distinguish between people addicted to prescription opioids and those addicted to illicit opioids such as fentanyl or heroin. Most U.S. overdoses involve illicit fentanyl.  

That said, the responses indicate that many people view opioid addiction through an ideological lens.

There was broad agreement among conservatives, moderates and liberals that opioid overdose deaths are a serious problem. Overall, 88% rated it as a very serious problem. 

But when it comes to responsibility for reducing overdose deaths, conservatives were more likely than liberals to say people who use opioids and their family members bear a personal responsibility for reducing the number of deaths.

Liberals, on the other hand, were more likely than conservatives to say pharmaceutical companies, as well as federal, state and local governments, were responsible for fixing the problem.

Only about one in four thought that nonprofit organizations were responsible for the opioid crisis.  

Perceived Responsibility for Reducing Opioid Overdose Deaths

SOURCE: jama

Conservatives were also more likely to have a stigmatized view of people with opioid use disorder. Over half of conservatives (52%) said they were unwilling to have a neighbor with an opioid addiction (compared to 27% of liberals), and 71% of conservatives said they would not want someone with an opioid addiction to marry into their family (compared to 48% of liberals).

Attitudes About People With Opioid Addiction

SOURCE: jama

The findings highlight just how widespread the stigma still is when it comes to opioid use.

"It remains striking that nearly one-half of self-described liberals indicated unwillingness to have a person with opioid addiction marry into their family," wrote Harold Pollack, PhD, a Professor of Public Health at the University of Chicago, in a commentary also published in JAMA. "The stigma of current opioid addiction crosses political lines."

Respondents who have a personal experience with opioids — who experienced opioid addiction themselves, had a family member or close friend with addiction, or knew someone who died from overdose — showed a greater willingness to have a person with opioid addiction as a neighbor or in-law.

Interestingly, people with that lived experience were slightly more likely than others (82.2% vs 79.3%) to state that people who use opioids are responsible for reducing opioid overdose deaths.

In his commentary, Pollack said the findings carry important implications for public health messaging regarding harm reduction programs such as free syringes, naloxone distribution, and fentanyl test strips. 

"These evidence-informed interventions face continued resistance, most notably from communities and families that experience direct harms arising from the opioid epidemic, who are understandably drawn to abstinence-based approaches rather than to approaches that some perceive as encouraging continued drug use or as replacing one addiction with another," Pollack said.

The survey findings are a subset of data drawn from a much larger survey designed to test public messaging campaigns about Medicaid programs that treat substance use disorder.

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.

CRPS: When Pain Becomes a Disease

By Madora Pennington

For Pattie Christensen, Complex Regional Pain Syndrome (CRPS) started after she had surgery for carpal tunnel syndrome in 2022. She opted for a local anesthetic, since it was a simple procedure.

Everything seemed fine until a month passed after her second hand surgery. Christensen felt something was wrong — very wrong. The outside of her hand started to hurt terribly. When she talked to her surgeon, he pointed out that the area now hurting had not even been involved in the surgery. The region that was operated on had healed well.

Things got worse. Soon her hand swelled to where her fingers looked like raw, discolored sausage. That’s when she got the bad news: Christensen had CRPS, a debilitating chronic pain condition that can be ignited by a simple fracture, sprain, surgery, or even a cardiovascular event.

CRPS causes dysfunction and confusion in the nervous system, amping up pain in an injured area. The pain then migrates to other nerves in non-injured areas. Most commonly, the CRPS pain settles and remains in a hand. Early treatment is the best chance to stop the progression of CRPS, but for many it becomes a long-term or even lifelong problem.

Christensen now makes videos about her life with CRPS on YouTube from her home in Salt Lake City, runs a Facebook support group, and tries to remain optimistic. Unfortunately, like most people with CRPS, she suffers from migraines.

According to a new study of 88 patients with CRPS in Australia, two out of three started having migraines or a worsening of their migraines after CRPS took hold.

“We found that migraine headaches often began or got worse after the injury that triggered CRPS. There seemed to be a direct connection between the limb injury and the headaches as they were often on the same side of the body and symptoms overlapped. That is, one condition may feed the other,” says lead author Peter Drummond, PhD, a Psychology Professor at Murdoch University.

“Unfortunately, many people with CRPS face the prospect of enduring a lifetime of pain because understanding is poor and treatment options are limited.”

One in every five people in the study has headaches almost every day, something Christensen can relate to.

“I never know if I’m going to have a bad migraine,” she says.

One of her migraine relief medications costs Christensen $150 per pill. She only takes that when it gets very bad.

She describes a recent episode: “I had dry heaves. I was crying.” She started with half of her expensive pills and felt nothing. It took $300 of medication and a period of lying down to get any relief. “I can’t say I felt great, I just felt okay and was able to work.”

CRPS is a disease of pain signaling gone wrong. People with CRPS tend to have extreme light sensitivity, foreheads painful to touch, and hyperalgesia (feeling pain from non-painful stimuli).

In the Australian study, participants with worse limb pain and hyperalgesia were more headache-prone. And the patients who were younger when their pain started were more likely to end up with headaches.

“We hope that greater recognition of the link between CRPS and migraine will clarify understanding of both conditions and will result in more effective treatment of headaches and a better quality of life for people with CRPS,” says Drummond.

CRPS seems to result from an overactive inflammatory response in the brain and spinal cord (neuroinflammation), a hyperactive nervous system (central sensitization), and problems with the body’s natural pain dampening signals.

Researchers say this heightened pain feedback creates a positive loop where pain increases. The mechanisms behind migraines and CRPS, both quite disabling on their own, fuel each other.

Those who never had migraines before the start of CRPS are likely to get them. And those who already had migraines will get more of them.  Although it may sound like it, CRPS is not psychosomatic. There are very real internal body processes that have gone wrong.  

Federal and State Warnings May Be Increasing 7-OH Sales

By Pat Anson

Federal and state efforts to ban the sale of 7-hydroxymitragynine (7-OH) products may be having the unintended effect of increasing sales of the kratom extract, which is a potent pain reliever.

The owner of Kansas City-based American Shaman, the largest U.S. producer and seller of 7-OH products, says sales have increased since the FDA sent a warning letter to his company in July alleging its 7-OH tablets were being sold illegally as adulterated dietary supplements.

“We’re busier than ever,” says Vince Sanders, who estimates that millions of Americans are using 7-OH for pain relief and as a mood enhancer. “More people are familiar with it now than there were a year ago. All this press just makes more and more people educated about it, and more people go out and try it.”

7-hydroxymitragynine is a naturally occurring alkaloid found in kratom, an herbal supplement used in southeast Asia for centuries as a stimulant and pain reliever. Kratom contains only trace amounts of 7-OH, but Sanders has developed a process that makes it more concentrated and potent. 

Although technically not an opioid, 7-OH has opioid-like effects. Last summer, the FDA asked the DEA to classify 7-OH as an illegal Schedule One controlled substance, claiming it was a dangerous and addictive substance “more potent than morphine.” While the DEA has yet to act on that request, Florida, Ohio, California, and several other states and municipalities have recently moved to ban 7-OH sales.  

‘This Isn’t Some Party Drug’

While there are anecdotal reports that 7-OH is addictive, there is little solid evidence that people are overdosing or being harmed by it. And American Shaman continues to sell it, even though thousands of its tablets have been seized by the FDA.

Sanders believes 7-OH may be at least partially responsible for the recent decline in drug overdoses, because it keeps pain sufferers from turning to more dangerous substances like illicit fentanyl and other street drugs. Some use it as an alternative to Suboxone to treat opioid withdrawal symptoms. 

“There's probably roughly 75,000 people walking the earth today that wouldn't be here, and hundreds of thousands of others that have used 7-OH to completely stop taking a street drug,” Sanders told PNN..

“This isn't some party drug. It's not like, ‘Oh my gosh, I feel so high. This is incredible.’ That's not what 7-OH does. 7-OH is tremendous for pain and it definitely is a mood enhancer. It puts you in a better mood, but it doesn't make you high, like alcohol, marijuana or a traditional opioid. It doesn’t have that effect.”

7-OH is so effective that Sanders advises pain sufferers to use it sparingly in small amounts, and to take a break from it at least once a week to avoid building a tolerance that requires higher doses.  

“If you take it appropriately, you won't build a tolerance. You're not going to build an addiction to it. My 82 year old mother has been using it for nearly two years now. She needed a dual hip replacement, but refused to get it. She was almost to the point of not being mobile, she was in so much pain. But now she gets along like normal. It's amazing. Just takes her pain away.”

Are pain patients using 7-OH? We posed that question to PNN readers on our Facebook page and got some mixed responses.

“It absolutely works! Gets me through an eight hour shift every single day,” said one poster.   

“Best pain relief I ever had,” said another.

“Very effective, but it is addictive. It’s helped a lot of people, but it’s hurt some people as well,” warned one poster.

“Can’t stop taking them. It’s been over a year (and) trying to get down to below 100 mg a day is tough. I cannot have a normal digestion process anymore. Sucks and costs a lot of money,” warned another 7-OH user.

Some drug testing companies have started looking for 7-OH in blood and urine samples. Clinical Reference Laboratory in Kansas tested for it in a random batch of 1,000 samples from across the country. Surprisingly, 7-OH was detected more often than fentanyl and prescription opioids like oxycodone and morphine.

“We found a 1.09% positive rate, which is, depending on the population, higher than all the other opiates we test for combined,” CEO Robert Thompson told the Kansas City Star. “That was pretty concerning to me.”

As perplexing as 7-OH may be to health officials and drug regulators, there’s another kratom extract called pseudoindoxyl that’s even more potent and gaining in popularity. Derived from the alkaloid mitragynine, pseudoindoxyl also has opioid-like effects, but without the respiratory depression and risk of overdose that comes with traditional opioids.  

“For pain relief, it's better than 7-OH. The science would indicate that it's probably five times more potent for pain than 7-OH,” says Sanders, who sells pseudoindoxyl chewable tablets on American Shaman’s website.

He has yet to get any warning letters telling him to stop.

Medicare Plans to End Most Telehealth Coverage Soon

By Crystal Lindell

Telehealth access was greatly expanded during the COVID-19 pandemic, but that expansion is slated to end this month for many older patients. Medicare is planning to end most coverage for telehealth appointments as of January 31, 2026.

There are some exceptions to the new policy. Telehealth appointments for those living in a rural area or seeking care in a rural area will still be covered. So will appointments for monthly home dialysis for end-stage renal disease; appointments for acute stroke; and appointments for behavioral health disorders.

The new policy only applies to Original Medicare plans. Medicare Advantage Plans may still cover telehealth appointments.

It’s baffling that this type of policy is being implemented for Medicare patients at all, seeing as how most people on Medicare are senior citizens — a demographic that is more likely to have mobility issues as well as a higher risk of falls.

The American Medical Association is calling on the federal government to make telehealth coverage permanent ahead of this month’s deadline. Congress has repeatedly extended the telehealth flexibilities for Medicare patients, but often at the last moment. The AMA says the constant procrastination creates uncertainty for millions of patients and their physicians.

“As the current waiver deadline approaches, Congress must finally act decisively to prevent a disruptive and abrupt halt to the expanded telehealth services that have improved care continuity, chronic disease management, and access for rural and underserved communities,” said AMA President Bobby Mukkamala, MD.

The AMA says telehealth offers the potential for long-term savings through early medical intervention, improved chronic disease management, and reduced use of expensive emergency care and inpatient services. Telehealth also has higher appointment completion rates and reduces hospital readmissions. In short, it helps our complex healthcare system work more efficiently and at a lower cost. 

“Now is the time for lawmakers to secure innovation, modernize care delivery, and protect access to telehealth for all Medicare beneficiaries by passing comprehensive, forward-looking reform,” the AMA said.

Speaking from personal experience, I am reminded of the time my grandma fell on the ice in front of her home a few years ago and broke her hip. The injury led to a months-long recovery process that included an extended stay at a rehabilitation facility. Aside from how inconvenient the entire episode was, it was also an extremely painful injury for her to endure.

Today, we limit how often she leaves the house to reduce the risk of her falling again. And we are especially cautious whenever the temperatures drop low enough to create icy patches on the ground.

Thus, whenever possible, we opt for telehealth appointments to keep grandma safe. Aside from reducing her fall risk, they also lower the risk of her being exposed to viruses at an in-person doctor’s office.

It seems like common sense that seniors in particular would have easy access to telehealth services, and my hope is that Congress will act and extend that access before the deadline.