health

FDA reverses surprise rejection of Moderna’s mRNA flu vaccine

anti-vaccine, fda, health, moderna, robert f kennedy jr, vinay prasad / Beth Washington / February 18, 2026

Anti-vaccine agenda

Agency insiders told reporters that a team of career scientists was ready to review the vaccine and held an hourlong meeting with Prasad to present the reasons for moving forward with the review. David Kaslow, a top career official responsible for reviewing vaccines, also wrote a memo detailing why the review should proceed. Prasad rejected the vaccine application anyway.

According to today’s announcement, the FDA reversed that rejection when Moderna proposed splitting the application, seeking full approval for the vaccine’s use in people aged 50 to 64 and an accelerated approval for use in people 65 and up. That latter regulatory pathway means Moderna will have to conduct an additional trial in that age group to confirm its effectiveness after it’s on the market.

Andrew Nixon, spokesperson for the US Department of Health and Human Services, confirmed the reversal to Ars Technica. “Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Nixon said in a statement. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”

The FDA typically takes a levelheaded approach to working with companies, rarely making surprising decisions or rejecting applications outright. While Prasad claimed the rejection was due to the control vaccine, the move aligns with Health Secretary Robert F. Kennedy Jr.’s broader anti-vaccine agenda.

Kennedy and the allies he has installed in federal positions are particularly hostile to mRNA technology. Moderna has already lost more than $700 million in federal contracts to develop pandemic vaccines. Next month, Kennedy’s MAHA Institute is hosting an anti-vaccine event that alleges there’s a “massive epidemic of vaccine injury.” The event description claims without evidence that use of mRNA vaccines is linked to “rising rates of acute and chronic illness.”

Vaccine makers and industry investors, meanwhile, are reporting that Kennedy’s relentless anti-vaccine efforts are chilling the entire industry, with companies abandoning research and cutting jobs. In comments to The New York Times, Moderna’s president, Stephen Hoge, said, “There will be less invention, investment, and innovation in vaccines generally, across all the companies.”

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WHO slams US-funded newborn vaccine trial as “unethical”

anti-vaccine, CDC, health, hepatitis B, Robert F Kenned Jr., WHO / 9u50fv / February 14, 2026

“Exploiting scarcity is not ethical,” the WHO wrote in its statement today.

Dangerous trial

The United Nations health agency highlighted that the hepatitis B vaccine birth dose is “an effective, and essential public health intervention” that has “been used for over three decades, with more than 115 countries including it in their national schedules. “

“It prevents life‑threatening liver disease by stopping mother‑to‑child transmission at birth,” the WHO wrote, noting that more than 12 percent of adults in Guinea-Bissau have chronic hepatitis B.

In a section subtitled “Why withholding the vaccine is unethical,” the WHO lays out all the reasons the trial is dangerous.

“From what is publicly described, the [trial] protocol does not appear to ensure even a minimum level of harm reduction and benefit to the study participants (e.g., screening pregnant women and vaccinating newborns exposed to hepatitis B),” the WHO wrote.

As a proven lifesaving vaccine, withholding it from some study participants would expose newborns to serious and potentially irreversible harm, including chronic infection, cirrhosis, and liver cancer, the WHO argues. There is no scientific justification for withholding a proven intervention, and there is no credible evidence of the safety concerns that Benn and her colleagues claim to be looking for in their trial. The WHO also noted that the publicly available information about the trial indicates that it will be a single-blind, no-treatment-controlled design, which “raises a significant likelihood of substantial risk of bias, limiting interpretability of the study results and their policy relevance.”

As of now, the trial appears to be suspended. Nature News reported that in a January 22 press conference, health officials in Guinea-Bissau said that a technical and ethical review was pending. “There has been no sufficient coordination in order to take a final decision regarding the study,” Quinhin Nantote, the minister of public health for Guinea-Bissau, said. “Faced with this situation, we decided to suspend it.”

Previously, the Africa Centres for Disease Control and Prevention suggested that the trial would not go forward. However, the US Department of Health and Human Services provided a statement saying that it was “proceeding as planned.”

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Trump official overruled FDA scientists to reject Moderna’s flu shot

fda, health, moderna, vinay prasad / Beth Washington / February 12, 2026

Still, while Moderna largely stuck with its plan to use a standard dose for all participants, it altered its plans based on the feedback. Specifically, it added a comparison of a high-dose vaccine to some older participants and provided the FDA with an additional analysis.

This wasn’t enough for Prasad, who, according to the Journal’s sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency’s practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation. Trump’s FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”

A senior FDA official suggested to Stat, meanwhile, that the door might not be entirely closed for Moderna’s flu vaccine. The official said that the company could toss the data for the 65 and up participants and, perhaps, grovel.

“It is entirely feasible that if they come back, maybe even show some humility and say, ‘Yes, we didn’t follow your recommendation. Just take a look at the 50 to 65 group, where there’s a little more equipoise,’” the official told Stat. “Then the review team could say, ‘We’ll consider that cohort.’”

The Journal notes that Moderna is at least the ninth company to have received a surprise rejection from Prasad and his team. The unpredictability is raising fears about the industry’s ability to obtain investments and innovate.

Prasad, a blood cancer specialist who has no expertise or experience in vaccine regulation, is also facing internal problems at the agency. His management style has created an environment “rife with mistrust and paranoia,” according to Stat. The Journal reports that several complaints have been filed against him, including some involving sexual harassment, retaliation against subordinates, and verbally berating staﬀ.

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Dewormer ivermectin as cancer cure? RFK Jr.’s NIH funds “absurd” study.

cancer, health, ivermectin, NCI, NIH, robert f kennedy jr / Shannon Garcia / February 10, 2026

The National Cancer Institute is using federal funds to study whether cancer can be cured by ivermectin, a cheap, off-patent anti-parasitic and deworming drug that fringe medical groups falsely claimed could treat COVID-19 during the pandemic and have since touted as a cure-all.

Large, high-quality clinical trials have resoundingly concluded that ivermectin is not effective against COVID-19. And there is no old or new scientific evidence to support a hypothesis that ivermectin can cure cancer—or justify any such federal expenditure. But, under anti-vaccine Health Secretary Robert F. Kennedy Jr.—who is otherwise well-known for claiming to have a parasitic worm in his brain—numerous members of the medical fringe are now in powerful federal positions or otherwise hold sway with the administration.

During a January 30 event, Anthony Letai, a cancer researcher the Trump administration installed as the director of the NCI in September, said the NCI was pursuing ivermectin.

“There are enough reports of it, enough interest in it, that we actually did—ivermectin, in particular—did engage in sort of a better preclinical study of its properties and its ability to kill cancer cells and we’ll probably have those results in a few months. So we are taking it seriously.”

The comments were highlighted today in a report from KFF Health News. Ars Technica was also at the event, “Reclaiming Science: The People’s NIH,” which was hosted by the MAHA [Make America Healthy Again] Institute. In the rest of his comments, Letai seemed to make a noticeable effort to temper expectations while also trying to avoid offending any ivermectin believers. “It’s not going to be a cure-all for cancer,” he said. At another point, he said that even if there are signals of anti-cancer properties in the preclinical studies, “I can tell you again, it’s not a really strong signal.”

Dewormer ivermectin as cancer cure? RFK Jr.’s NIH funds “absurd” study. Read More »

Penisgate erupts at Olympics; scandal exposes risks of bulking your bulge

fillers, health, hyaluronic acid, Olympics, paraffin, penis, ski jumpers / Beth Washington / February 7, 2026

Bruno Sassi, the communications director for FIS, the international ski and snowboard federation, seemed less amused, telling the BBC, “There has never been any indication, let alone evidence, that any competitor has ever made use of a hyaluronic acid injection to attempt to gain a competitive advantage.”

But what if they did? Here’s what we know about hyaluronic acid and paraffin for penis augmentation.

Hyaluronic acid

While some news outlets have played up the “acid” part of its name, hyaluronic acid is not some nefarious flesh-melting hazard. It’s a common filler used for various clinical purposes.

Hyaluronic acid is a polysaccharide that is naturally found in a wide variety of tissues in the human body, including the skin, eyes, and connective tissue. It’s a chief component of the extracellular matrix. It attracts water molecules to itself, creating volume that can provide structural support. In a pure form, it has no tissue or even species specificity and therefore is considered to have little risk of sparking immune responses.

As such, hyaluronic acid gel fillers are used in a variety of medical procedures, with approval from the Food and Drug Administration. Hyaluronic acid (HA) fillers are injected into joints, particularly knees, to relieve pain from mild to moderate arthritis, which can decrease the natural amount of HA in joints. Age also decreases natural levels of HA, and one of the main uses of HA fillers is for cosmetic purposes—plumping lips and cheeks, and minimizing the appearance of wrinkles and fine lines in the face. HA fillers can also be used inside the eye in a variety of surgeries, including cataract extraction and corneal transplants. It can also be used topically for wound care and to relieve skin pain and itching.

For these purposes, the most common adverse effects are pain, bruising, redness, itching, and swelling, which usually last for just a few days. In extremely rare cases, there can be more serious side effects from injections, such as bacterial infections, tissue death (from blocked blood flow), and a granulomatous foreign body reaction, in which the immune system tries to clear a foreign substance, such as bacterial impurities, leading to a collection of immune cells.

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Bad sleep made woman’s eyelids so floppy they flipped inside out, got stuck

eye, eyelids, floppy eyelid syndrome, health, NEJM, obstructive sleep apnea, sleep / DJ Henderson / February 5, 2026

Exhausted elastin

As such, the correct next step for addressing her floppy eyelids wasn’t eye surgery or medication—it was a referral for a sleep test.

The patient did the test, which found that while she was sleeping, she stopped breathing 27 times per hour. On the apnea–hypopnea index, that yields a diagnosis of moderate-level OSA.

With this finding, the woman started using a continuous positive airway pressure (CPAP) machine, which delivers continuous air into the airway during sleep, preventing it from closing up. Along with some eye lubricants, nighttime eye patches, and a weight-loss plan, the woman’s condition rapidly improved. After two weeks, her eyelids were no longer inside out, and she could properly close her eyes. She was also sleeping better and no longer had daytime drowsiness.

Doctors don’t entirely understand the underlying mechanisms that cause floppy eyelid syndrome, and not all cases are linked to OSA. Researchers have hypothesized that genetic predispositions or anatomical anomalies may contribute to the condition. Some studies have found links to underlying connective tissue disorders. Tissue studies have clearly pointed to decreased amounts or abnormalities in the elastin fibers of the tarsal plate, the dense connective tissue in the eyelids.

For people with OSA, researchers speculate that the sleep disorder leads to hypoxic conditions (a lack of oxygen) in their tissue. This, in turn, could increase oxidative stress and reactive oxygen species in the tissue, which can spur the production of enzymes that break down elastin in the eyelid. Thus, the eyelids become lax and limp, allowing them to get into weird positions (such as inside out) and leading to chronic irritation of the eye surface.

The good news is that most people with floppy eye syndrome can manage the condition with conservative measures, such as CPAP for those with OSA, as did the woman in New York. But some may end up needing corrective surgery.

Bad sleep made woman’s eyelids so floppy they flipped inside out, got stuck Read More »

Trump admin is “destroying medical research,” Senate report finds

Bhattacharya, health, NIH / DJ Henderson / February 4, 2026

Senators also pressed the director on the future of the NIH, noting that it has been hamstrung by the ongoing chaos, putting upcoming grant funding at risk, too. Of the NIH’s 27 institutes and centers, Bhattacharya testified, “I think it’s 15″ that are without a director. Sen. Patty Murray (D-Wash.), meanwhile, noted that more than half of the institutes are on track to lose all their voting advisory committee members by the end of the year—and grants cannot be approved without sign-off from these committees. Bhattacharya responded that they’re working on it.

Weasely answers on vaccines

In the course of the hearing, senators also tried to assess Bhattacharya’s loyalty to Kennedy’s dangerous anti-vaccine ideology, which includes the false and thoroughly debunked claim that vaccines cause autism.

Sanders asked Bhattacharya directly: “Do vaccines cause autism? Yes/no?”

“I do not believe that the measles vaccine causes autism,” Bhattacharya responded.

“No, uh-uh,” Sanders quickly interjected. “I didn’t ask [about] measles. Do vaccines cause autism?”

“I have not seen a study that suggests any single vaccine causes autism,” Bhattacharya responded.

But this, too, is an evasive answer. Note that he said “any single vaccine,” leaving open the possibility that he believes vaccines collectively or in some combination could cause autism. The measles vaccine, for instance, is given in combination with immunizations against mumps, rubella, and sometimes varicella (chickenpox).

It would also be false to suggest vaccines in combination are linked to autism; numerous studies have found no link between autism and vaccination generally. Still, this is a false idea that Kennedy and the like-minded anti-vaccine advocates he has installed into critical federal vaccine advisory roles are now pursuing.

Later in the hearing, Bhattacharya also indicated that when he said “I have not seen a study,” he was suggesting that it was because such studies have not been done—which is also false; routine childhood vaccines have been extensively studied for safety and efficacy.

“I’ve seen so many studies on measles vaccines and autism that established that there is no link,” [to autism], he said in an exchange with Hassan on the subject. “The other vaccines are less well studied.”

Trump admin is “destroying medical research,” Senate report finds Read More »

Newborn dies after mother drinks raw milk during pregnancy

ACOG, baby, death, fda, food safety, health, Infectious disease, kennedy, listeria, pregnancy, raw milk / DJ Henderson / February 3, 2026

A newborn baby has died in New Mexico from a Listeria infection that state health officials say was likely contracted from raw (unpasteurized) milk that the baby’s mother drank during pregnancy.

In a news release Tuesday, officials warned people not to consume any raw dairy, highlighting that it can be teeming with a variety of pathogens. Those germs are especially dangerous to pregnant women, as well as young children, the elderly, and people with weakened immune systems.

“Raw milk can contain numerous disease-causing germs, including Listeria, which is bacteria that can cause miscarriage, stillbirth, preterm birth, or fatal infection in newborns, even if the mother is only mildly ill,” the New Mexico Department of Health said in the press release.

The health department noted that it could not definitively link the baby’s death to the raw milk the mother drank. But raw milk is notorious for transmitting Listeria monocytogenes bacterium. The Food and Drug Administration has a “Food Safety for Moms-to-Be” webpage about Listeria, in which it poses the question and answer: “How could I get listeriosis? You can get listeriosis by eating raw, unpasteurized milk and unpasteurized milk products… .”

Listeria is a particular danger during pregnancy. When exposed, pregnant people are 10 times more likely to develop a Listeria infection than other healthy adults because altered immune responses during pregnancy make it harder to fight off infections. Further, Listeria is one of a few pathogens that are able to cross the placental barrier and infect a developing fetus.

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A cup of coffee for depression treatment has better results than microdosing

depression, health, LSD, Mental Health, microdosing, syndication / DJ Henderson / January 31, 2026

The effect of microdosing have been overstated, at least when it comes to depression.

About a decade ago, many media outlets—including WIRED—zeroed in on a weird trend at the intersection of mental health, drug science, and Silicon Valley biohacking: microdosing, or the practice of taking a small amount of a psychedelic drug seeking not full-blown hallucinatory revels but gentler, more stable effects. Typically using psilocybin mushrooms or LSD, the archetypal microdoser sought less melting walls and open-eye kaleidoscopic visuals than boosts in mood and energy, like a gentle spring breeze blowing through the mind.

Anecdotal reports pitched microdosing as a kind of psychedelic Swiss Army knife, providing everything from increased focus to a spiked libido and (perhaps most promisingly) lowered reported levels of depression. It was a miracle for many. Others remained wary. Could 5 percent of a dose of acid really do all that? A new, wide-ranging study by an Australian biopharma company suggests that microdosing’s benefits may indeed be drastically overstated—at least when it comes to addressing symptoms of clinical depression.

A Phase 2B trial of 89 adult patients conducted by Melbourne-based MindBio Therapeutics, investigating the effects of microdosing LSD in the treatment of major depressive disorder, found that the psychedelic was actually outperformed by a placebo. Across an eight-week period, symptoms were gauged using the Montgomery-Åsberg Depression Rating Scale (MADRS), a widely recognized tool for the clinical evaluation of depression.

The study has not yet been published. But MindBio’s CEO Justin Hanka recently released the top-line results on his LinkedIn, eager to show that his company was “in front of the curve in microdosing research.” He called it “the most vigorous placebo controlled trial ever performed in microdosing.” It found that patients dosed with a small amount of LSD (ranging from 4 to 20μg, or micrograms, well below the threshold of a mind-blowing hallucinogenic dose) showed observable upticks in feelings of well-being, but worse MADRS scores, compared to patients given a placebo in the form of a caffeine pill. (Because patients in psychedelic trials typically expect some kind of mind-altering effect, studies are often blinded using so-called “active placebos,” like caffeine or methylphenidate, which have their own observable psychoactive properties.)

This means, essentially, that a medium-strength cup of coffee may prove more beneficial in treating major depressive disorder than a tiny dose of acid. Good news for habitual caffeine users, perhaps, but less so for researchers (and biopharma startups) counting on the efficacy of psychedelic microdosing.

“It’s probably a nail in the coffin of using microdosing to treat clinical depression,” Hanka says. “It probably improves the way depressed people feel—just not enough to be clinically significant or statistically meaningful.”

However despairing, these results conform with the suspicions of some more skeptical researchers, who have long believed that the benefits of microdosing are less the result of a teeny-tiny psychedelic catalyst, and more attributable to the so-called “placebo effect.”

In 2020, Jay A. Olson, then a PhD candidate in the Department of Psychiatry at McGill University in Montreal, Canada, conducted an experiment. He gave 33 participants a placebo, telling them it was actually a dose of a psilocybin-like drug. They were led to believe there was no placebo group. Other researchers who were in on the bit acted out the effects of the drug, in a room treated with trippy lighting and other visual stimulants, in an attempt to curate the “optimized expectation” of a psychedelic experience.

The resulting paper, titled “Tripping on Nothing,” found that a majority of participants had reported feeling the effects of the drug—despite there being no real drug whatsoever. “The main conclusion we had is that the placebo effect can be stronger than expected in psychedelic studies,” Olson, now a postdoctoral fellow at the University of Toronto, tells WIRED. “Placebo effects were stronger than what you would get from microdosing.”

More than a stick in the eye to the microdosing faithful, Olson maintains that the study’s key findings had more to do with the actual role, and power, of the placebo effect. “The public has a lot of misconceptions about the placebo effect,” he says. “There’s this assumption that placebo effects are extremely weak, or that they’re not real.”

Olson goes on to say that placebo effects in psychedelic trials can be further juiced by the hype around the drugs themselves. Patients may enter a trial expecting a certain experience, and their mind is able to conjure a version of that experience, in turn. In Olson’s study, it wasn’t a matter of microdosing effects not being real, but that those effects may be caused by environment, or patient expectation. As he puts it: “It can be true at the same time that microdosing can have positive effects on people, and that those effects are perhaps almost entirely placebo.”

This itself raises a sticky question about MindBio’s study. How could a placebo group, who thinks they’re taking LSD, perform better than an active control group, members of which both think they’re taking LSD and are actually taking it? The answer comes from the design of the study itself.

Using what’s called a “double-dummy” design, MindBio’s researchers informed patients that they’d either be receiving LSD, a caffeine pill, or a dose of methylphenidate, better known as Ritalin or Concerta. (No patients were actually administered the methylphenidate.) This means that patient expectation was lowered, as they could ascribe any perceived effects to either the LSD or either of the active placebos. Patients taking LSD microdoses may well have believed they were merely on a stimulant. All patients followed an adaptation of the “Fadiman protocol,” a popular microdosing programme that sees patients taking a small dose of the given drug once every three days.

Jim Fadiman, the veteran psychedelic researcher after whom the protocol is named, rejects MindBio’s conclusions, and trial design, out of hand. Because, Fadiman believes, patients were given the active caffeine placebo, their reported benefits may well be attributable not to a pure placebo effect, but to the actual psychoactive properties of that drug.

“Double-dummy is a remarkably apt term,” Fadiman, 86, sneers. “What I know is that if you take enough caffeine, you will not be depressed!”

Fadiman points to MindBio’s earlier, Phase 2A study, recently published in the journal Neuropharmacology, which drew markedly different conclusions. It was a non-blinded, so-called “open label” study, meaning patients knew definitely that they were being microdosed with LSD. This study found that MADRS scores decreased by 59.5 percent, with effects lasting as long as six months. It also found improvements in stress, rumination, anxiety, and patient quality of life. Fadiman says that this reportage is more consistent with his own research on microdosing. “Their prior study did wonderfully with LSD,” Fadiman says. “I have collected literally hundreds of real world reports over the years that validate those findings.”

MindBio’s Hanka stands by the science. “We are bewildered at the significant difference between the open label Phase 2A trial results and the Phase 2B trial results,” he says. “But that is the nature of good science—a properly controlled trial will get a proper result. Our Phase 2B trial was of the highest standard, a triple-blind, double-dummy, active placebo controlled trial. I haven’t seen another psychedelic trial that has gone to these lengths to control and blind a trial.”

Despite these findings, some microdosing true believers don’t seem especially shaken. In 2017, writer Ayelet Waldman (best known as the author of the Mommy-Track Mysteries series of novels that follow the adventures of stay-at-home-mom-cum-sleuth Juliet Applebaum) published A Really Good Day, a diaristic account of her own self-experiments using microdosing to treat an intractable mood disorder. She tells WIRED she’s not especially bothered by the implication that her positive shifts in mood may have merely been placebo. “In my book I took very seriously the possibility that what I was experiencing was the mother of all placebo effects,” Waldman says. “I wrote about this a number of times in various chapters and decided in the end it didn’t matter. What mattered was that I felt better.”

Perhaps that’s true enough. If the effects are measurable, and repeatable, then it should hardly matter if they’re attributable to a sub-perceptual dose of lysergic acid, or to the (perhaps equally profound) mysteries of the placebo. Still, one cannot help but wonder why anyone looking to use LSD to aid severe clinical depression would bother assuming the legal risk of procuring and consuming a drug still classified under Schedule I by the US Drug Enforcement Administration.

Certainly, for his part, Justin Hanka seems content to pivot MindBio’s research into a new field. His next project is “Booze A.I.”: a smartphone app that uses artificial intelligence to scan the human voice for relevant biomarkers that determine blood alcohol concentration. He’s leaving microdosing in the rearview. “I put millions of dollars into this myself,” he says. “Had I known six years ago what I know about psychedelics, I probably wouldn’t have ventured into the microdosing field.”

This story originally appeared on wired.com.

Wired.com is your essential daily guide to what’s next, delivering the most original and complete take you’ll find anywhere on innovation’s impact on technology, science, business and culture.

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Having that high-deductible health plan might kill you, literally

cancer, deductivels, health, health insurance, survival / Kelly Newman / January 31, 2026

Having a health insurance plan with a high deductible could not only cost you—it could also kill you.

A new study in JAMA Network Open found that people who faced those high out-of-pocket costs as well as a cancer diagnosis had worse overall survival and cancer-specific survival than those with more standard health plans.

The findings, while perhaps not surprising, are a stark reminder of the fraught decisions Americans face as the price of health care only continues to rise and more people try to offset costs by accepting insurance plans with higher deductibles—that is, higher out-of-pocket costs they have to pay before their health insurance provider starts paying its share.

The issue is particularly critical right now for people who have insurance plans through the Affordable Care Act marketplace. Prices for those plans have skyrocketed this year after Congress failed to extend critical tax credits. Without those credits, monthly premiums for ACA plans have, on average, more than doubled. Early data on ACA enrollments for 2026 not only suggests that fewer people are signing up for the plans, but also that those who are enrolling are often choosing bronze plans, which are high-deductible plans.

In the study, researchers considered plans to be “high-deductible health plans” (HDHPs) if their deductibles were at least $1,200 to $1,350 for individuals or $2,400 to $2,700 for families between 2011 and 2018 (with the cutoffs increasing within the ranges during that time). For context, the average individual deductible for an ACA bronze plan in 2026 is about $7,500, according to KFF.

Risky plans

Based on previous data, such high out-of-pocket costs are known to lead people to delay or decrease health care—they may skip doctor visits, put off diagnostics, and avoid treatments. But for the new study, researchers led by Justin Barnes at Mayo Clinic in Rochester, Minnesota, wanted to know, more directly, if the plans were linked to lower survival—specifically for cancer patients, who obviously need more care than others.

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TrumpRx delayed as senators question if it’s a giant scam with Big Pharma

anti-kickback statute, health, kickbacks, telehealth, trumprx / 9u50fv / January 30, 2026

In other words, DTC websites run by pharmaceutical companies use “hand-picked telehealth companies to inappropriately steer patients toward specific, high-cost medications and inflate Big Pharma’s profit margins,” the senators write.

In an investigation last year of DTC platforms from Eli Lilly and Pfizer, the senators found that the pharmaceutical giants “spent up to $3 million combined for partnerships with telehealth companies, who funneled patients to the manufacturers’ products. … In one instance, 100 percent of the patients routed to a virtual visit with one of Eli Lilly’s chosen telehealth companies received a prescription.”

There’s already reason to be suspicious of conflicts of interest with TrumpRx, the senators note. There’s a “potential relationship between TrumpRx and an online dispensing company, BlinkRx, on whose Board the President’s son, Donald Trump, Jr., has sat since February 2025” the senators write.

The lawmakers are concerned that TrumpRx will violate the anti-kickback statute, which bars payments for inducing patients to use services or products that are reimbursable by a federal health care program.

Brian Reid, principal at health consultancy Reid Strategic, speculated to Politico that the delay of TrumpRx’s debut may be related to anti-kickback statute concerns.

“In any other administration, it would 100 percent be the AKS stuff,” Reid said. “It’s clear there’s a lawyer somewhere at HHS who has concerns about anti-kickback.”

TrumpRx delayed as senators question if it’s a giant scam with Big Pharma Read More »

She’ll mess with Texas: Nurse keeps mailing abortion pills, despite Paxton lawsuit

Abortion, abortion pills, health, Policy, telehealth, texas / Beth Washington / January 29, 2026

Texas sues Delaware nurse practitioner shipping out hundreds of abortion pills each month.

A Texas fight with a nurse practitioner may eventually push the Supreme Court to settle an intensifying battle between states with strict abortion-ban laws and those with shield laws to protect abortion providers supporting out-of-state patients.

In a lawsuit filed Tuesday, Texas Attorney General Ken Paxton accused Debra Lynch, a Delaware-based nurse practitioner, of breaking Texas laws by shipping abortion pills that Lynch once estimated last January facilitated “up to 162 abortions per week” in the state.

“No one, regardless of where they live, will be freely allowed to aid in the murder of unborn children in Texas,” Paxton’s press release said.

In August, Paxton sent a cease-and-desist letter to shut down Lynch’s website, Her Safe Harbor, which she runs with her husband, Jay, a former communications director for Delaware’s health and social services department, alongside other volunteer licensed prescribers.

Fretting that Her Safe Harbor continues to advertise that Texas patients can get access to abortion pills “within days,” Paxton characterized Her Safe Harbor as an “extremist group” supposedly endangering women and unborn children in the state. To support that claim, Paxton cited two unrelated lawsuits where men allegedly ordered pills from other providers to poison pregnant partners and force miscarriages.

But Lynch told The New York Times that her lawyers advised her to ignore the demand letter, because Delaware’s shield law is one of the strongest in the country. Just before Paxton sent the letter, Delaware’s law was updated to clarify that it specifically “provides protection from civil and criminal actions that arise in another state that are based on the provision of health care services that are legal in Delaware,” the Times noted. And “even before that,” she said her lawyers “advised her that Delaware’s shield law protects her work.”

Paxton seems to expect the court will agree that shield laws cannot overrule state abortion ban laws or laws prohibiting out-of-state health practitioners from operating on Texans without a state license. His lawsuit demands a temporary and permanent injunction shutting down Her Safe Harbor, as well as the highest possible fines.

In a loss, Lynch could owe millions, as each mail order would be considered a violation of the state’s Human Life Protection Act, Paxton alleged, triggering a minimum $100,000 fine per violation. She could also face substantial jail time, the Austin American-Statesman reported, since Texas abortion “providers risk up to 99 years in prison.”

However, Lynch told the Times on Wednesday that the lawsuit will not stop her from shipping pills into Texas. She’s been anticipating this fight since at least the beginning of last year and remains committed to helping pregnant people in states with strict abortion laws get support from a qualified health provider. She fears that otherwise, they’ll feel driven to take riskier steps that could endanger their lives.

“I don’t fear Ken Paxton,” Lynch told the Statesman last January. “I don’t fear getting arrested or anything like that.”

Nurse plans to defend shield laws

This is the third lawsuit Paxton has filed against an out-of-state abortion pill provider, his press release noted. Legal experts who support abortion ban laws, as well as those supporting abortion shield laws, told the NYT they expect the Supreme Court to eventually weigh the arguments on both sides. If that happened, it could impact law enforcement in about a third of states with “near-total” abortion bans, as well as more than 20 states that enacted abortion shield laws.

To Lynch, abortion ban laws have already proven disastrous, doing more harm than good.

The Statesman cited data from the Society of Family Planning (SFP), showing that after the Supreme Court overturned Roe v. Wade in 2022, medication abortion by telehealth became much more popular in the US. In 2022, this type of service accounted for approximately 1 in 25 abortions; by 2024, the numbers had shot to 1 in 5.

“Nearly half of those prescriptions went to patients in states with abortion bans or restrictions on telehealth abortion,” the Statesman reported, and SFP’s data showed that Texas residents, particularly, were turning more to telehealth. In the first half of 2024, 2,800 Texans per month received abortion medication by mail, which was “more than any other abortion-restricted state,” the data showed.

SFP also found that, overall, abortions had increased following tighter restrictions, totaling more than 1 million in 2023, which SFP noted was “the highest number in more than a decade.”

Lynch told the Statesman that abortion-ban laws “hadn’t stopped her from mailing the medications. They hadn’t stopped patients from receiving them. They just created hundreds of miles between patients and providers,” leaving women “feeling isolated and afraid to access a procedure that’s legal in half the country, and which had been legal everywhere in the US for half a century.”

“They’re truly alone,” Lynch said. “That frightens the hell out of me.”

Lynch’s case, or one of the other Texas lawsuits, could put shield laws to the test and one day clarify for all US residents if medication abortion by telehealth is legal in states with more restrictive laws.

A win could back up shield laws and block Texas from prosecuting providers like Lynch, as well as from enforcing proposed laws like Texas’ House Bill 991. If passed, that law would let Texas residents sue Internet service providers for failing to block abortion pill providers’ websites.

On the Her Safe Harbor website, Lynch and her partners say that patient safety is their priority and that they go beyond what typical providers offer to ensure that people seeking abortions are well cared for. The website details which abortion pills patients will receive (Mifepristone and Misoprostol), while, unlike other abortion providers, also sends pain and nausea medication at no cost. Both the NYT and the Statesman’s reporters confirmed that Her Safe Harbor is also available for patients to check in with any questions or concerns throughout the process.

Paxton seems fixated on Her Safe Harbor’s claims that orders can be shipped to all states, regardless of state laws, which he alleged makes women not seeking abortions vulnerable to attacks by male partners.

However, Her Safe Harbor takes steps to speak directly with patients in states with the most restrictive abortion laws. An Ars test showed that patients seeking consultations from such states are encouraged to call health care providers directly, rather than submit a form that their state could try to subpoena, a step that could prevent the kinds of attacks that Paxton fears. Of course, anyone can still choose to initiate the process using the consultation form, with Her Safe Harbor providing reassurances that the group “has never and will never disclose any private health data to any authority. We will not comply if we are ever subpoenaed.”

“This lawsuit is not about patient safety”

In email comments, Jay Lynch, who helps run Her Safe Harbor with his wife, told Ars that Paxton’s lawsuit is not trying to “protect life” but seeking to “silence medicine.”

“Every day, we provide evidence-based medical care to women who are scared, vulnerable, and often out of options,” Jay said. “We assess medical history. We evaluate risk. We follow clinical guidelines. We act to prevent complications, hospitalizations, infertility, and death. That is what medicine is supposed to do: save lives and reduce harm.”

Jay accused Paxton of “trying to expand state control across borders” and “intimidate providers everywhere.”

“This lawsuit is not about patient safety,” Jay said. “It is about who gets to decide what care is allowed: trained medical professionals—or politicians with no clinical expertise.”

To Jay, a win for Paxton would put patients in a risky place, forcing doctors and nurses to choose between “doing what is medically right, or doing what is politically ‘safe.’”

“That is a dangerous place for any healthcare system to be,” Jay said, noting that “when politicians override clinicians, patients pay the price” through delayed treatment, worsening injuries, preventable emergencies, lost fertility, or their lives.

Working with her husband and other providers, Lynch told the NYT that Her Safe Harbor is currently shipping out hundreds of packages a month. She vowed that as long as threats to abortion access continued to risk women’s lives, the shipments would never stop.

“Women are losing their lives and children are winding up orphans, and babies are being born with non-life-sustaining medical conditions” due to abortion bans and restrictive laws, Lynch told the NYT. “As long as that is happening, there’s absolutely nothing or nobody that will deter us from our mission to bring health care to women.”

Ashley is a senior policy reporter for Ars Technica, dedicated to tracking social impacts of emerging policies and new technologies. She is a Chicago-based journalist with 20 years of experience.

She’ll mess with Texas: Nurse keeps mailing abortion pills, despite Paxton lawsuit Read More »