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    Kennedy’s Views Mix Mistrust of Business With Bizarre Health Claims

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    Seven years after Americans celebrated the licensing of Jonas Salk’s polio vaccine, President John F. Kennedy called on Congress to finance a nationwide vaccination program to stamp out what he called the “ancient enemies of our children”: infectious disease.Now Kennedy’s nephew, Robert F. Kennedy Jr., is the nation’s chief critic of vaccines — a public health intervention that has saved millions of lives — and President-elect Donald J. Trump’s pick to become the next secretary of health and human services. Mr. Kennedy calls himself a vaccine safety activist. The press calls him a vaccine skeptic. His detractors call him an anti-vaxxer and a conspiracy theorist.Whatever one calls him, Mr. Kennedy is a polarizing choice whose views on certain public health matters beyond vaccination are far outside the mainstream. He opposes fluoride in water. He favors raw milk, which the Food and Drug Administration deems risky. And he has promoted unproven therapies like hydroxychloroquine for Covid-19. His own relatives called his presidential bid “dangerous for our country.”If there is a through line to Mr. Kennedy’s thinking, it appears to be a deep mistrust of corporate influence on health and medicine. In some cases, that has led him to support positions that are also embraced by public health professionals, including his push to get ultra-processed foods, which have been linked to obesity, off grocery store shelves. His disdain for profit-seeking pharmaceutical manufacturers and food companies drew applause on the campaign trail.People close to him say his commitment to “make America healthy again” is heartfelt.“This is his life’s mission,” said Brian Festa, a founder of We the Patriots U.S.A., a “medical freedom” group that has pushed back on vaccine mandates, who said he has known Mr. Kennedy for years.But like Mr. Trump, Mr. Kennedy also has a tendency to float wild theories based on scanty evidence. And he has hinted at taking actions, like prosecuting leading medical journals, that have unnerved the medical community. On Friday, many leading public health experts reacted to his nomination with alarm.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Robert F. Kennedy Jr.’s FDA Wish List: Raw Milk, Stem Cells, Heavy Metals

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      Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.Robert F. Kennedy Jr. has been unflinching in his attacks on the Food and Drug Administration in recent weeks, saying he wants to fire agency experts who have taken action against treatments that have sometimes harmed people or that teeter on the fringe of accepted health care practice.How much influence Mr. Kennedy will have in President-elect Donald J. Trump’s next administration remains unclear, with some suggesting that he could act as a White House czar for policy over several federal health agencies. Mr. Trump has voiced support for Mr. Kennedy in recent weeks, saying he will let him “go wild on health.” In his acceptance speech, Mr. Trump reiterated his support for Mr. Kennedy’s involvement on health matters.Some of Mr. Kennedy’s priorities are relatively standard, such as focusing on the health effects associated with ultraprocessed foods. Yet others threaten to undermine F.D.A. authority to rein in inappropriate medical treatments or to warn about products that can damage the public health.A spokeswoman for Mr. Kennedy did not respond to interview requests.Days before the election, in a post on X that has received 6.4 million views, Mr. Kennedy threatened to fire F.D.A. employees who have waged a “war on public health.” He listed some of the products that he claimed the F.D.A. had subjected to “aggressive suppression,” including ivermectin, raw milk, vitamins as well as therapies involving stem cells, and hyperbaric oxygen.Some items that he singled out had become flash points for conservative voters during the coronavirus pandemic, including ivermectin, which was found to be an ineffective treatment against Covid.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

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      The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Salmonella Outbreak Prompts Egg Recall by Wisconsin Farm

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      Officials said 65 people in nine states have been infected in the outbreak, which has been traced to an egg farm. No deaths have been reported.A salmonella outbreak that has sickened dozens of people in nine states prompted a recall of certain brands of eggs on Friday after officials said they traced the source of the infections to a farm in Wisconsin.State health officials said that 42 of the 65 people infected were in Wisconsin. Many people reported eating eggs at restaurants in the state before they got sick.Officials were able to trace the source of the eggs to Milo’s Poultry Farms of Bonduel, Wis., where they identified the outbreak strain in a packing facility and a hens egg-laying house, the U.S. Centers for Disease Control and Prevention said.All carton sizes and egg types produced at the farm, which either bear the label “Milo’s Poultry Farms” or “Tony’s Fresh Market,” were recalled by the farm, the U.S. Food and Drug Administration said.The eggs were distributed to retail stores and food service suppliers in Illinois, Michigan and Wisconsin, the F.D.A. said. The recall includes all expiration dates. The exact number of eggs recalled was not immediately available.No deaths have been reported in the outbreak, but 24 people were hospitalized. The first case was reported in late May, but most infections were reported in July and August, according to the C.D.C.The reported number of people infected is likely an undercount because it usually takes weeks to determine if an infection is part of an outbreak and because some people may recover without testing for the bacteria, the C.D.C. said.Aside from Wisconsin, infections were reported in California, Colorado, Illinois, Iowa, Michigan, Minnesota, Utah and Virginia. Illinois reported the second-highest number of infections with 11, followed by Minnesota, which reported three.The symptoms of the bacterial infection include diarrhea, fever and abdominal pain and usually begin within three days of ingesting the contaminated food, the F.D.A. said.Symptoms usually clear up within a week, but people with weakened immune systems, including young children and older adults, are more susceptible to severe, and sometimes fatal, infections, the F.D.A. said.The egg recall came after a deadly summer outbreak of listeria that prompted the recall of seven million pounds of Boar’s Head deli meat products.That outbreak has resulted in nine deaths and dozens of hospitalizations and the temporary shutdown of a Boar’s Head plant in Virginia, where inspectors had found black mold, water dripping over meat and dead flies. More

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      FDA Declines to Approve MDMA Therapy, and Seeks Further Study

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      The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.The F.D.A. said there was insufficient data to allow its use, and it asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.An additional clinical trial could add years, and millions of dollars, to the approval process.If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. Supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and did not recommend the treatment. On two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that the drug therapy’s benefits did not outweigh the risks.The agency generally follows the recommendations of its outside panels. Critics, however, have questioned the panel’s expertise, noting that only one of its 11 members had experience in psychedelic medicine.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      FDA Panel Weights MDMA Therapy for PTSD

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      An independent group of experts is meeting Tuesday to consider whether to allow use of this illegal drug, also known as Ecstasy, to treat PTSD. The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      One in Five Milk Samples Nationwide Shows Genetic Traces of Bird Flu

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      There is no evidence that the milk is unsafe to drink, scientists say. But the survey result strongly hints that the outbreak may be widespread.Federal regulators have discovered fragments of bird flu virus in roughly 20 percent of retail milk samples tested in a nationally representative study, the Food and Drug Administration said in an online update on Thursday.Samples from parts of the country that are known to have dairy herds infected with the virus were more likely to test positive, the agency said. Regulators said that there is no evidence that this milk poses a danger to consumers or that live virus is present in the milk on store shelves, an assessment public health experts have agreed with.But finding traces of the virus in such a high share of samples from around the country is the strongest signal yet that the bird flu outbreak in dairy cows is more extensive than the official tally of 33 infected herds across eight states.“It suggests that there is a whole lot of this virus out there,” said Richard Webby, a virologist and influenza expert at St. Jude Children’s Research Hospital.Dr. Webby said that he believed it was still possible to eradicate the virus, which is known as H5N1, from the nation’s dairy farms. But it will be difficult to design effective control measures without knowing the scope of the outbreak, he said.The findings also raise questions about how the virus has evaded detection and where else it might be silently spreading. Some scientists have criticized the federal testing strategy as too limited to reveal the true extent of viral spread.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Biotech Exec Gets 7 Years in Prison for False Claims About Rapid Covid-19 Test

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      Prosecutors said Keith Berman falsely claimed he had invented a blood test that could detect Covid-19 in 15 seconds. His lawyer said he had put “genuine effort” into developing such a test.The former chief executive of a biotechnology company who, during the early days of the pandemic, falsely claimed that he had invented a blood test that could detect Covid-19 in 15 seconds was sentenced on Friday to seven years in prison for securities fraud, federal prosecutors said.From February 2020 to December 2020, the former executive, Keith Berman, 70, of Westlake Village, Calif., engaged in a scheme to defraud people into investing in his company, Decision Diagnostics Corporation, by claiming the test could detect Covid using a finger prick sample of blood, prosecutors said.In March and April 2020, Mr. Berman issued 12 “false and misleading” news releases describing the rapid Covid test, which his company called GenViro, prosecutors wrote. Decision Diagnostics’ stock price jumped by more than 1,500 percent during the period, prosecutors said.In reality, prosecutors said, Mr. Berman had “privately confided in a friend the test could not actually detect Covid-19.”Prosecutors accused Mr. Berman, the sole director of the publicly traded medical device company, of capitalizing on people’s fears about the pandemic in an effort to resuscitate the company’s fortunes.Mr. Berman’s scheme resulted in about $28 million in investor losses, prosecutors said. Mr. Berman was indicted in December 2020, and he pleaded guilty in December 2023 to securities fraud, wire fraud and obstruction of an official proceeding.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      The Persistent Threat to Abortion Rights

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      The Supreme Court this week heard the first major challenge to abortion rights since it struck down Roe v. Wade two years ago — an attempt to severely limit access to mifepristone, the most commonly used abortion pill in the country, by a group of doctors who are morally opposed to the practice.The justices seem prepared to throw out the lawsuit. During oral arguments, they questioned whether the doctors had suffered the harm necessary to bring the suit in the first place.But that should come as small comfort to anyone concerned for the future of reproductive freedom in America. Judges at the state and federal level are ready to further restrict reproductive options and health care access. The presumptive Republican nominee for president, Donald Trump, has indicated support for a 15-week national abortion ban. And while the Supreme Court, in overturning Roe, ostensibly left it to each state to decide abortion policy, several states have gone against the will of their voters on abortion or tried to block ballot measures that would protect abortion rights. Anti-abortion forces may have had a tough week in the Supreme Court, but they remain focused on playing and winning a longer game.Even potential victories for reproductive freedom may prove short-lived: The mifepristone case, for instance, is far from dead. Another plaintiff could bring the same case and have it considered on the merits, a possibility Justice Samuel Alito raised during oral arguments.“Is there anybody who could challenge in court the lawfulness of what the F.D.A. did here?” he asked the solicitor general, Elizabeth Prelogar. Such a challenge would be exceptionally weak, given that the F.D.A. provided substantial support for its approval and regulatory guidance on the use of mifepristone, but the right-wing justices on the Roberts court may be willing to hear it again anyway. The justices have already illustrated their hostility to the authority of administrative agencies, and that hostility may persist even in the face of overwhelming scientific evidence.Then there is the Comstock Act, a 151-year-old federal law that anti-abortion activists are trying to revive to block the mailing of mifepristone and other abortion medication. During the oral arguments this week, Justices Alito and Clarence Thomas repeatedly expressed their openness to the use of the law, which was pushed by an anti-vice crusader decades before women won the right to vote. If anti-abortion activists can get themselves before a sympathetic court and secure a national injunction on this medication being mailed, they may well be able to block access to abortion throughout the country, including in states where it is legal.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More