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Drug Administration

The FDA approved a new non-opioid painkiller. Its maker's stock is rising

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Vertex Pharmaceuticals (VRTX) stock rose on Friday after the Food and Drug Administration (FDA) approved its new painkiller, the first of its kind approved by regulators.

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The Return of Snake Oil

The Atlantic

www.theatlantic.com › health › archive › 2025 › 01 › patent-medicine-supplements-rfk-trump › 681515

In a Massachusetts cellar in 1873, Lydia Pinkham first brewed the elixir that would make her famous. The dirt-brown liquid, made from herbs including black cohosh and pleurisy root, contained somewhere between 18 and 22 percent alcohol—meant as a preservative, of course. Within a couple of years, Pinkham was selling her tonic at $1 a bottle to treat “women’s weaknesses.” Got the blues? How about inflammation, falling of the womb, or painful menstruation? Lydia E. Pinkham’s Vegetable Compound was the solution. Pinkham’s matronly smile, printed on labels and advertisements, became as well known as Mona Lisa’s.

Lydia E. Pinkham’s Vegetable Compound was one of thousands of popular and lucrative patent medicines—health concoctions dreamed up by chemists, housewives, and entrepreneurs—that took the United States by storm in the 19th and early 20th centuries. These products promised to treat virtually any ailment and didn’t have to reveal their recipes. Many contained alcohol, cocaine, morphine, or other active ingredients that ranged from dubious to dangerous. Dr. Guild’s Green Mountain Asthmatic Compound was available in cigarette form and included the poisonous plant belladonna. Early versions of Wampole’s Vaginal Cones, sold as a vaginal antiseptic and deodorizer, contained picric acid, a toxic compound used as an explosive during World War I. Patent-medicine advertisements were unavoidable; by the 1870s, 25 percent of all advertising was for patent medicines.

After the Pure Food and Drug Act was passed in 1906, the newly created Food and Drug Administration cracked down on miracle elixirs. But one American industry is still keeping the spirit of patent medicine alive: dietary supplements. In the U.S., vitamins, botanicals, and other supplements are minimally regulated. Some can improve people’s health or address specific conditions, but many, like the medicines of old, contain untested or dangerous ingredients. Nevertheless, three-quarters of Americans take at least one. Some take far more. Robert F. Kennedy Jr., the longtime conspiracy theorist and anti-vaccine activist who’s awaiting Senate confirmation to run the Department of Health and Human Services, has said he takes a “fistful” of vitamins each day. Kennedy has in recent years championed dietary supplements and decried their “suppression” by the FDA—an agency he would oversee as health secretary. Now he’s poised to bring America’s ever-growing supplement enthusiasm to the White House and supercharge the patent-medicine revival.  

The newly created FDA eventually required all pharmaceutical drugs—substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease—to be demonstrably safe and effective before they could be sold. But dietary supplements, as we call them now, were never subject to that degree of scrutiny. Vitamins were sold with little interference until the “megadosing” trend of the late 1970s and ’80s, which began after the chemist Linus Pauling started claiming that large amounts of vitamin C could stave off cancer and other diseases. The FDA announced its intention to regulate vitamins, but the public (and the supplement industry) revolted. Mel Gibson starred in a television ad in which he was arrested at home for having a bottle of Vitamin C, and more than 2.5 million people participated in a “Save Our Supplements” letter-writing campaign. Congress stepped in, passing the 1994 Dietary Supplement Health and Education Act, which officially exempted dietary supplements from the regulations that medications are subject to.

Since then, the FDA has generally not been responsible for any premarket review of dietary supplements, and manufacturers have not usually had to reveal their ingredients. “It’s basically an honor system where manufacturers need to declare that their products are safe,” says S. Bryn Austin, a social epidemiologist and behavioral scientist at the Harvard T. H. Chan School of Public Health. The agency will get involved only if something goes wrong after the supplement starts being sold. As long as they disclose that the FDA hasn’t evaluated their claims, and that those claims don’t involve disease, supplement makers can say that their product will do anything to the structure or function of the body. You can say that a supplement improves cognition, for example, but not that it treats ADHD. These claims don’t have to be supported with any evidence in humans, animals, or petri dishes.

In 1994, the dietary-supplement industry was valued at $4 billion. By 2020, it had ballooned to $40 billion. Patent-medicine creators once toured their products in traveling medicine shows and made trading cards that people collected, exchanged, and pasted into scrapbooks; today, supplement companies sponsor popular podcasts, Instagram stories are overrun with supplement ads, and influencers make millions selling their own branded supplements. The combination of modern wellness culture with lax regulations has left Americans with 19th-century-like problems: Pieter Cohen, an associate professor of medicine at Cambridge Health Alliance, has found a methamphetamine analogue in a workout supplement, and omberacetam, a Russian drug for traumatic brain injuries and mood disorders, in a product marketed to help with memory.

Last year, Kennedy accused the FDA of suppressing vitamins and other alternative health products that fall into the dietary-supplement category. But “there is no truth about the FDA being at war on supplements over the last several decades,” Cohen told me. “In fact, they have taken an extremely passive, inactive approach.” Experts have repeatedly argued that the FDA needs more authority to investigate and act on supplements, not less. And yet, Kennedy continues to champion the industry. He told the podcaster Lex Fridman that he takes so many vitamins, “I couldn’t even remember them all.” Kennedy has vocally opposed additives in food and conflicts of interest in the pharmaceutical industry, but has failed to mention the dangerous additives in dietary supplements and the profits to be made in the supplement market. (Neither Kennedy nor a representative from the MAHA PAC responded to a request for comment.)

In an already permissive environment, Kennedy’s confirmation could signal to supplement manufacturers that anything goes, Cohen said. If the little regulation that the FDA is responsible for now—surveilling supplements after they’re on the market—lapses, more adulterated and mislabeled supplements could line store shelves. And Americans might well pour even more of our money into the industry, egged on by the wellness influencer charged with protecting our health and loudly warning that most of our food and drug supply is harmful. Kennedy might even try to get in on the supplement rush himself. Yesterday, The Washington Post reported that, according to documents filed to the U.S. Patent and Trademark Office, Kennedy applied to trademark MAHA last year, which would allow him to sell, among other things, MAHA-branded supplements and vitamins. (He transferred ownership of the application to an LLC in December. Kennedy’s team did not respond to the Post.)

A truly unleashed supplement industry would have plenty of tools at its disposal with which to seduce customers. Austin studies dietary supplements that make claims related to weight loss, muscle building, “cleansing,” and detoxing, many of which are marketed to not just adults, but teenagers too. “Those types of products, in particular, play on people’s insecurities,” she told me. They also purport to ease common forms of bodily or mental distress that can’t be quickly addressed by traditional medical care. Reducing stress is hard, but ordering the latest cortisol-reducing gummy on TikTok Shop is easy. Your doctor can’t force vegetables into your diet, but a monthly subscription of powdered greens can.

Judy Z. Segal, a professor emerita at the University of British Columbia who has analyzed patent-medicine trading cards from the 19th and 20th centuries, told me that supplement-marketing strategies “have not changed that much since the patent-medicine era.” Patent medicines appealed to ambient, relatable complaints; one ad for Burdock’s Blood Bitters asserted that there were “thousands of females in America who suffer untold miseries from chronic diseases common to their sex.” And the makers of patent medicine, like many modern supplement companies, used friendly spokespeople and customer testimonials while positioning their products as preventive care; according to one ad for Hartshorn’s Sarsaparilla, “The first deviation from perfect health should receive attention.”

In 1905, the muckraker Samuel Hopkins Adams lamented that “gullible America” was so eager to “swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and, far in excess of all other ingredients, undiluted fraud.” Compounds and elixirs go by different names now—nootropics, detoxes, adaptogens—but if Adams walked down any supplement aisle or browsed Amazon, he’d still find plenty of cure-alls. He could even pick up a bottle of Lydia E. Pinkham’s Herbal Supplement, which is sold as an aid for menstruation and menopause. Pinkham’s face smiles at buyers from the label, though its advertised benefits are now accompanied by a tiny disclaimer: “This statement has not been evaluated by the FDA.”

A Day for Pseudoscience in Congress

The Atlantic

www.theatlantic.com › health › archive › 2025 › 01 › rfk-jr-congress-confirmation-hearings › 681499

Shortly after birth, newborns in the United States receive a few quick procedures: an Apgar test to check their vitals, a heel stick to probe for genetic disorders and various other conditions, and in most cases, a hepatitis B vaccine. Without that last one, kids are at risk of getting a brutal, and sometimes deadly, liver condition. Senator Bill Cassidy of Louisiana happens to know quite a lot about that. Before entering Congress in 2009, he was a physician who has said he was so affected by an 18-year-old patient with liver failure from the virus that he spearheaded a campaign that vaccinated 36,000 kids against hepatitis B.

Cassidy, a Republican, will now play a major role in determining the fate of Robert F. Kennedy Jr., Donald Trump’s pick for health secretary, whose confirmation hearings begin today on Capitol Hill. Kennedy has said that the hepatitis B vaccine is given to children only because the pharmaceutical company Merck colluded with the government to get the shot recommended for kids, after the drug’s target market (“prositutes and male homosexuals,” by Kennedy’s telling) weren’t interested in the shot. Kennedy will testify in front of the Senate Finance Committee, where Cassidy and 26 other senators will get the chance to grill him about his views. Though it might seem impossible for an anti-vaccine conspiracist to gain the support of a doctor who still touts the work he did vaccinating children, Cassidy has not indicated how he will vote. Similar to the Democratic senators who have come out forcefully against Kennedy, Cassidy, in an interview with Fox News earlier this month, said that RFK Jr. is “wrong” about vaccines. But he also said that he did agree with him on some things. (Cassidy’s office declined my request to interview the senator.)

That Kennedy even has a chance of winning confirmation is stunning in its own right. A longtime anti-vaxxer with a propensity for far-fetched conspiracy theories, RFK Jr. has insinuated that an attempt to assassinate members of Congress via anthrax-laced mail in 2001 may have been a “false flag” attack orchestrated by “someone in our government” to gin up interest in the government preparing for potential biological weapon threats. He has claimed that COVID was “targeted to attack Caucasians and Black people,” and that 5G is being used to “harvest our data and control our behavior.” He has suggested that the use of antidepressants might be linked to mass shootings. Each one of these theories is demonstrably false. The Republican Party has often found itself at war with mainstream science in recent years, but confirming RFK Jr. would be a remarkable anti-science advance. If Republican senators are willing to do so, is there any scientific belief they would place above the wishes of Donald Trump?

A number of Republicans have already signaled where they stand. In the lead-up to the confirmation hearings, some GOP senators have sought to sanewash RFK Jr., implying that his views really aren’t that extreme. They have reason to like some of what he’s selling: After the pandemic, many Republicans have grown so skeptical of the public-health establishment that Kennedy’s desire to blow it up can seem enticing. And parts of RFK Jr.’s “Make America Healthy Again” agenda do in fact adhere to sound scientific evidence. His views on how to tackle America’s epidemic of diet-related diseases are fairly well reasoned: Cassidy has said that he agrees with RFK Jr.’s desire to take action against ultra-processed foods. Kennedy appears to have won over the two other Republican doctors on the committee, Senators Roger Marshall of Kansas and John Barrasso of Wyoming. Marshall has been so enthusiastic about Kennedy’s focus on diet-related diseases that he has created a “Make America Healthy Again” caucus in the Senate. Although Barrasso hasn’t formally made an endorsement, he has said that Kennedy would provide a “fresh set of eyes” at the Food and Drug Administration. (Spokespeople for Barrasso and Marshall did not respond to requests for comment.)

[Read: Everyone agrees Americans aren’t healthy]

Meanwhile, Kennedy appears to have gone to great lengths to sand down his extremist views and present himself as a more palatable candidate. “He told me he is not anti-vaccine. He is pro–vaccine safety, which strikes me as a rational position to take,” Senator John Cornyn of Texas told Politico. He has also done more to drum up unnecessary fear about COVID shots than perhaps anyone else in the country. Nearly four years ago, Kennedy petitioned the federal government to revoke authorization for the shots, because “the current risks of serious adverse events or deaths outweigh the benefits.” (COVID shots are highly safe and effective. A spokesperson for Kennedy did not respond to a request for comment.)

Especially on the right, Kennedy’s conspiracy theories have not consumed his candidacy: With concerns about conflicts of interest, his support of abortion, and generally strange behavior (such as dumping a dead bear in Central Park), there is much to debate. If Republican senators skirt around his falsehoods during today’s confirmation hearings, it will be evidence of their prevailing capitulation to Trump. And it also may be a function of Kennedy’s rhetorical sleights. As Benjamin Mazer recently wrote in The Atlantic, Kennedy is not simply a conspiracy theorist, but an excellent one. He’s capable of rattling off vaccine studies with the fluency of a virologist, which boosts his credibility, even though he’s freely misrepresenting reality.

[Read: RFK Jr. is an excellent conspiracy theorist]

During his recent appearance on Joe Rogan’s podcast, Kennedy claimed that thimerosal, a preservative containing mercury used to protect vaccines from contamination, was found to cause “severe inflammation” in the brain of monkeys. Kennedy was able to quickly name the lead author and introduce the methods as if he has read the study hundreds of times. But Kennedy’s central claim—that the brains of monkeys given thimerosal were severely inflamed—is a “total misrepresentation” of the study, its lead author, Thomas M. Burbacher, told me. The problem is that Kennedy gets away with these claims because very few listeners are going to log onto PubMed to track down the study Kennedy is referencing, let alone read through the entire thing.

In theory, senators should be equipped to push back on his schtick. RFK Jr.’s positions are hardly a mystery, and senators have advisers to help them prepare for such hearings. Regardless of Kennedy’s pseudoscientific beliefs, some Republicans may support him simply because they are wary of bucking their president. Before Kennedy even makes it to a full vote from the Senate, he has to receive approval from the Senate Finance Committee: Given the tight margins in the committee, Kennedy can’t afford to lose a single vote from Republicans sitting on that panel, assuming that no Democrats support his nomination. I reached out to the offices of seven Republican senators on the committee who haven’t already backed Kennedy for clarity on where they stand; none of them gave me a straight answer on how they’d vote.

In all likelihood, the first big decision in Kennedy’s nomination will fall to Cassidy. He has proved willing to oppose Trump before. Cassidy was one of seven Republicans who voted to convict Trump during his second impeachment proceedings. That led Louisiana’s Republican Party to formally censure him, and has drawn him a primary challenger for his 2026 reelection bid. Although Cassidy criticized Trump during the 2024 campaign, he now seems eager to support him. “Today, the American people start winning again,” Cassidy wrote in a statement on Inauguration Day.

Perhaps Cassidy will still dissect Kennedy’s views with the precision of a surgeon’s scalpel. He likes to dive deep into health-care minutiae any chance he gets. (I would know: He once pulled out his iPad and lectured me and other reporters about some arcane drug-pricing policy.) But if today’s meeting is full of softball questions, it could put RFK Jr. on his way to confirmation. That would send a message that, science-wise, the Senate is willing to cede all ground. Trump could pursue the most radical parts of the Project 2025 agenda, such as splitting up the CDC, or Kennedy could launch a full-blown assault on vaccines—and the Senate would be in a much less powerful position to stop it even if it wanted to. If senators hand the keys of a nearly $2 trillion health-care agency to a known conspiracy theorist, anything goes.

The FDA just approved Ozempic for kidney disease

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Novo Nordisk (NVO) announced today that its blockbuster drug Ozempic was approved by the Food and Drug Administration (FDA) as the first GLP-1 treatment for chronic kidney disease among people with type 2 diabetes.

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Costco's salmon recall is now in the FDA's highest-risk category

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This story incorporates reporting fromConsumerAffairs, AOL, BlackDoctor, Eat This%2c Not That! and KHQ.

The Food and Drug Administration (FDA) has elevated the recall status of Kirkland Signature Smoked Salmon products sold at Costco to a Class I, the agency’s most severe classification. This designation indicates…

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A Less Brutal Alternative to IVF

The Atlantic

www.theatlantic.com › health › archive › 2025 › 01 › ivf-ivm-pain-fertility › 681478

After my 20th shot of hormones, I texted my boyfriend, only half kidding, “I’m dying.” We had decided to freeze embryos, but after more than a week of drugs that made me feel like an overinflated balloon and forced me to take several secret naps a day, I no longer cared whether we froze anything. I was not doing this again.

In order to maximize the number of eggs that can be harvested from the human body, most women who undergo an egg retrieval spend two weeks, give or take, injecting themselves at home with a cocktail of drugs. The medications send the reproductive system into overdrive, encouraging the maximum number of egg-containing follicles to grow and mature at once. They can also cause itchiness, nausea, fatigue, sadness, headaches, moodiness, and severe bloating as your ovaries swell to the size of juicy lemons. Some people experience ovarian hyperstimulation, which can lead in rare cases to hospitalization. Studies have found the stress of fertility treatment to be a primary reason people stop pursuing it, even if they have insurance coverage.

Many people who continue with IVF feel that, if they want a child, they have no other choice. “Right now our treatment options are pretty binary,” Pietro Bortoletto, the director of reproductive surgery and a co-director of oncofertility at Boston IVF, told me. “Either you just put sperm inside the uterus. Or you do IVF, the full-fledged Cadillac of treatment.” But a third option is emerging, one that could reduce the cost and time that fertility patients spend at the doctor’s office and mitigate the side effects. It’s called in vitro maturation, or IVM. Whereas IVF relies on hormone injections to ripen a crop of eggs inside the body, IVM involves collecting immature eggs from the ovaries and maturing them in the lab. The first IVM baby was born in Korea in 1991, and since then, the method has generally yielded lower birth rates than IVF. Decades later, new scientific techniques are raising the possibility that IVM could be a viable alternative to IVF—at least for some patients—and free thousands of aspiring mothers from brutal protocols.

The challenge of IVM is to figure out how to make fragile, finicky human eggs mature in a dish as well as they do within the ovaries. The handful of researchers and companies leading the push to make IVM more mainstream are taking different approaches. One Texas-based company, Gameto, uses stem cells to produce something akin to an ovary in a dish, mimicking the chemical signals an egg would receive in the body. Last month, for the first time, a baby was born who was created using Gameto’s stem-cell medium, Fertilo. The fertility clinic at the University of Medicine and Pharmacy at Ho Chi Minh City, in Vietnam, uses a technique that involves first allowing the retrieved eggs to rest, then ripening them. Lavima Fertility, a company that spun out of research at the Free University of Brussels, is working on commercializing that technique.

For now, these new treatments aren’t commercially available in the United States. The Food and Drug Administration hasn’t historically weighed in on the media that human embryos grow in, but it asked Gameto to seek approval to market Fertilo. Gameto is now preparing for Phase 3 clinical trials. Lavima could face similar hurdles. Older IVM methods are available in the U.S., but not widely used. Meanwhile, more than a dozen women in countries where Fertilo has been cleared for use, which include Australia, Mexico, Peru, and Argentina, are carrying Fertilo-assisted pregnancies, according to the company.

Compared with IVF, IVM is far more gentle. Harvesting immature follicles requires only one or two days of hormonal injections, or skips the process altogether. Reducing the hormone doses necessarily means fewer side effects and cases of ovarian hyperstimulation syndrome. (It may also curtail any possible long-term health effects of repeated exposure to these hormones, which have not been well studied.) Skipping or reducing the drugs can also save women thousands of dollars and many visits to a provider for blood work and monitoring. For women who live far from fertility clinics, or can’t commit to so many visits for other reasons, this protocol could make the difference between undergoing treatment and not, Bortoletto said.

Historically, IVM has generated fewer mature eggs and embryos compared with IVF. The stats are improving, but even if IVM maintains an overall lower success rate than IVF, it still could be the better option for several groups of patients. Egg donors, many of whom undergo multiple retrieval cycles, could be good candidates. So could hyper-responders—patients whose ovaries naturally develop more follicles each month, thanks to their young age or conditions such as PCOS. IVM clinicians could gather enough eggs from hyper-responders that even if a smaller number mature in the lab than might have in the ovaries, a patient would still have a good chance of pregnancy. These patients are also at the highest risk for uncomfortable or dangerous IVF side effects. IVM could be a safer choice, and an effective one. In a 2021 committee opinion, the American Society for Reproductive Medicine concluded that IVM reduced the burden of fertility treatment for these groups of patients. Some studies of hyper-responders have found a live birth rate of 40 percent or higher per IVM cycle, a number on par with that of IVF.

Many women seek IVF because they are approaching their 40s and have few eggs left; they will likely never be good IVM candidates. But IVM might work just fine for patients with blocked fallopian tubes, single and LGBTQ people, and young women who want to freeze their eggs. It could also be useful to cancer patients, many of whom don’t have time to undergo a lengthy IVF cycle before beginning cancer treatment that threatens their fertility. The University of Medicine and Pharmacy in Vietnam primarily offers IVM to women with PCOS, women who appear to have a significant reserve of eggs, and women with a condition that mutes their response to hormonal stimulation. Lan Vuong, who heads the department of obstetrics and gynecology, told me the live-birth rate with IVM there is about 35 percent.

IVM could go far in helping to reduce the physical and emotional toll that fertility treatment takes on women at a time when more people than ever are seeking it out. In some ways, IVF’s burden on women has increased: In an effort to improve birth rates, new drugs, with their attendant side effects, have been added to the standard protocols in the decades since 1978, when the first IVF baby was born. Beyond IVM, some companies are exploring new ways to reduce pain points, for instance by replacing needle injections with oral medications, some of which aim to have gentler side-effect profiles, or by having patients monitor a cycle at home instead of schlepping to the doctor every other day. Dina Radenkovic, the CEO of Gameto, told me that, within the fertility industry, there is a “growing recognition that fertility treatments must be not only effective but also more humane.”

Knowing all this, I can’t help imagining how my own experience could have been different. My doctor eventually told me that part of the reason my cycle was so painful was that I was a hyper-responder, even at the advanced age of 37. If a gentler option had been available, I would have been a prime candidate.

Costco's DEI defense, Walmart's DEI backlash, and AI in fast food: Retail news roundup

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Costco (COST) is sticking to its diversity, equity, and inclusion (DEI) commitments, while Walmart faces backlash from investors over its DEI pullback. Walmart is also venturing into luxury resale, now selling brands like Chanel and Prada online. Meanwhile, the U.S. Food and Drug Administration (FDA) has banned red…

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The FDA bans red dye No. 3 in food. Here’s what that means

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The U.S. Food and Drug Administration (FDA) on Wednesdaybanned red dye No. 3 in food and beverages, decades after studies found it can cause cancer in lab rats. The synthetic dye, commonly found in candy, milkshakes, and cereal, has also raised concerns about its potential impact on children’s behavior.

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