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In the West, where herds of thousands of cattle are common, researchers are seeing cases rise at poultry and dairy operations. More than 50 workers have contracted the virus.
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In the West, where herds of thousands of cattle are common, researchers are seeing cases rise at poultry and dairy operations. More than 50 workers have contracted the virus.
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But the administration would likely face legal challenges if it proposed additional restrictions or an outright ban on pharma ads, says Jim Potter, executive director of the nonpartisan Coalition for Healthcare Communications. “The courts view advertising as a form of commercial speech, and they’ve ruled in a series of cases dating back to the 1970s that banning advertising violates First Amendment protections of freedom of speech,” he says. “If the administration wanted to unilaterally impose new rules, they would be on shakier legal ground today than in past years.”
That’s because the US Supreme Court last summer overturned the longstanding Chevron doctrine, which allowed federal agencies some latitude in how they interpreted ambiguous laws. The Supreme Court ruling shifts power from agencies like the FDA to the courts.
Ballreich and Weissman worry that Kennedy’s support of raw milk, vitamins, and disproven treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead to the agency approving medicines that lack scientific evidence.
“I think when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that is going to translate into reducing standards at FDA to enable the authorization and promotion of ineffective and dubious therapies, drugs, herbs, whatever,” Weissman says.
As HHS secretary, Kennedy would not be directly responsible for approving new drugs or treatments. That job falls to the FDA’s Center for Drug Evaluation and Research, which more often than not approves drugs based on the recommendations of independent advisory committees. But in a handful of controversial cases, the agency has approved drugs against this expert advice, such as when it greenlit Exondys 51, a drug for Duchenne muscular dystrophy, in 2016. FDA advisers said there was not enough evidence to show that the drug had actual clinical benefits.
RFK has also called for more scrutiny of vaccines, which already must be tested on thousands of healthy volunteers for several years before being licensed. This skepticism could play out in fewer vaccines making it to the market and more postmarket monitoring of approved vaccines.
Working with Mehmet Oz, Trump’s pick to lead the Centers for Medicare and Medicaid Services, Kennedy could push to get questionable treatments or medical devices covered by Medicare, the federal health insurance program for people aged 65 or older and those with disabilities.
But Kennedy’s anti-pharma stance could be tempered by congressional Republicans, who have been historically reticent about more regulation, and Trump’s other appointees. The incoming president has made a more conventional pick for FDA commissioner in Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins. Meanwhile, Vivek Ramaswamy, founder of the pharmaceutical company Roivant Sciences and a Republican presidential candidate, has been tapped to lead the Department of Government Efficiency, or DOGE, a planned presidential advisory commission under the second Trump administration.
“There are huge question marks with the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. “It’s hard to know how this is really going to shake out.”
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Produce has been the source of many foodborne illness outbreaks in the US this year
The Image Party/Shutterstock
Apple sauce containing lead. Onions carrying E. coli. Deli meat spreading listeria. The past year has seen alert after alert from US public health officials warning of contamination in the food supply, both in packaged and prepared foods. Going to the grocery store – or even out to eat – has seemingly become a real gamble.
But lately, much of the public worry over food safety has been hijacked by Robert…
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Millions of US residents may be drinking water containing the potentially harmful compound
Yiu Yu Hoi/Getty Images
A common disinfectant in drinking water breaks down into a chemical compound that we know almost nothing about, including whether it has any potential toxic health effects to those who drink it.
Chlorine has been used to sanitise drinking water for more than a century. However, some drinking water systems in the US, UK and Australia now use another closely related chemical disinfectant called chloramine. That’s because chlorine byproducts were linked to bladder and colon cancer, low birth rates and miscarriage, says …
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President-elect Donald Trump announced that he would nominate former independent presidential candidate Robert F. Kennedy Jr. to run the Department of Health and Human Services (HHS). It’s the fulfillment of an implied promise that Trump made at a rally at Madison Square Garden in New York in late October, where he said he would let Kennedy “go wild on health.”
Kennedy, a former Democrat and scion of the wealthy political family, first rose to prominence as an environmental lawyer and anti-vaccine activist. Around 2015, he joined the board of the nonprofit Children’s Health Defense (CHD), which alleges that conditions like autism and attention deficit hyperactivity disorder (ADHD) are caused by environmental factors, including harmful agents in vaccines. Kennedy has repeatedly spread misinformation about vaccines, and in 2021 was named by the Center for Countering Digital Hate as one of the “disinformation dozen,” spreading misinformation about the Covid-19 pandemic across Instagram, Twitter, and Facebook.
He has suggested, in contradiction to all reputable scientific research, that Covid-19 may have been “ethnically targeted” to spare Ashkenazi Jews and Chinese people and that HIV does not cause AIDS, and implied that vaccine mandates are worse than the Holocaust. He also said in a 2012 deposition that a worm ate part of his brain and then died.
Kennedy’s account was banned from Instagram in 2021 for spreading vaccine misinformation. His account was restored in 2023, when he announced his run for office.
In August, Kennedy suspended his campaign and threw his support behind Trump, saying, “If President Trump is elected and honors his word, the vast burden of chronic disease that burdens and bankrupts the country will disappear,” at the time. He launched a parallel slogan to Trump’s MAGA—Make America Healthy Again (MAHA)—focused on “prioritizing regenerative agriculture, preserving natural habitats, and eliminating toxins from our food, water, and air.”
HHS oversees 13 federal agencies—which Kennedy has indicated he would gut—including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Disease Control (CDC).
Kennedy’s position, however, is still contingent on congressional approval. Previous HHS leaders have had long careers in the public health field or within the department itself before serving as the head. A Republican-controlled Senate might defer to Trump, or might point to Kennedy’s aggressive promotion of conspiracy theories, long career as a loyal Democrat, and muddled positions on abortion as reasons to block his accession.
Though Kennedy has promised to overhaul the entire system, experts who spoke to WIRED say that he would likely come up against longstanding regulations that would be hard to outmaneuver. Health policies are also heavily informed by advisory committees, which are stacked with medical and public health experts, and would take time to shift in order to fully change the government’s recommendations.
Still, Kennedy as HHS director would have substantial power to dismiss staff and declare public health emergencies.
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In a long-sought move, the US Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant that the agency concluded last year is not effective at relieving stuffy noses.
Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drugmakers will no longer be able to include phenylephrine in products for the temporary relief of nasal congestion.
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA’s previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.
The slow-moving abandonment of phenylephrine is years in the making. The decongestant was originally approved by the FDA in 1976, but it came to prominence after the “Combat Methamphetamine Epidemic Act of 2005” came into effect, and pseudoephedrine—the main component of Sudafed—moved behind the pharmacy counter to keep it from being used to make methamphetamine. With pseudoephedrine out of easy reach at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.
In 2007, an FDA panel reevaluated the drug, which supposedly works by shrinking blood vessels in the nasal passage, opening up the airway. While the panel upheld the drug’s approval, it concluded that more studies were needed for a full assessment. After that, three large, carefully designed studies were conducted—two by Merck for the treatment of seasonal allergies and one by Johnson & Johnson for the treatment of the common cold. All three found no significant difference between phenylephrine and a placebo.
Last year, the FDA reevaluated the drug again, taking into consideration the new studies and taking a deeper look at the 14 studies from the 1950s to 1970s that earned phenylephrine its initial approval. The FDA noted that those 14 studies assessed congestion using a dubious measure of nasal airway resistance that has since been abandoned. But even with the shoddy measurement, the studies provided mixed efficacy results. And the overall finding of efficacy hinged on only two of the studies, which were conducted at the same lab.
No other lab was ever able to replicate the positive results from those two studies. And when FDA scientists carefully looked through the data, they found evidence that some of the numbers could have been fudged and that the results were “too good to be real.”
As a final nail in phenylephrine’s coffin, modern studies suggest that when phenylephrine is taken orally, it’s highly metabolized in the gut, leaving less than 1 percent of the consumed dose as active in the body. The finding explains why oral doses don’t cause the constriction of blood vessels throughout the body that could lead to an uptick in blood pressure—a side effect sometimes seen with pseudoephedrine. While researchers initially thought the lack of blood pressure increases was a positive finding, in retrospect, it was a hint that the drug wasn’t working.
With that, a panel of advisers for the FDA voted unanimously, 16 to 0, that oral doses of phenylephrine are not effective at treating a stuffy nose. Afterward, CVS announced that it would remove products that had phenylephrine as the sole active ingredient.
Despite the seemingly damning evidence, the industry group representing makers of phenylephrine-containing products—the Consumer Healthcare Products Association (CHPA)—still disputed the FDA’s move.
“CHPA is disappointed in FDA’s proposal to reverse its long-established view of oral PE [phenylephrine],” CHPA CEO Scott Melville said in a statement Thursday. The CHPA maintains its position on the drug’s efficacy. “As science and methods advance, new data should be considered in the context of the full weight of available evidence, not as a complete replacement of the previous body of evidence—especially when considering an ingredient as safely and widely used as PE. CHPA will review the Proposed Order and submit comments accordingly,” Melville said.
This story originally appeared on Ars Technica.
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