U.S. Study on Puberty Blockers Goes Unpublished Because of Politics, Doctor Says

The leader of the long-running study said that the drugs did not improve mental health in children with gender distress and that the finding might be weaponized by opponents of the care.An influential doctor and advocate of adolescent gender treatments said she had not published a long-awaited study of puberty-blocking drugs because of the charged American political environment.The doctor, Johanna Olson-Kennedy, began the study in 2015 as part of a broader, multimillion-dollar federal project on transgender youth. She and colleagues recruited 95 children from across the country and gave them puberty blockers, which stave off the permanent physical changes — like breasts or a deepening voice — that could exacerbate their gender distress, known as dysphoria.The researchers followed the children for two years to see if the treatments improved their mental health. An older Dutch study had found that puberty blockers improved well-being, results that inspired clinics around the world to regularly prescribe the medications as part of what is now called gender-affirming care.But the American trial did not find a similar trend, Dr. Olson-Kennedy said in a wide-ranging interview. Puberty blockers did not lead to mental health improvements, she said, most likely because the children were already doing well when the study began.“They’re in really good shape when they come in, and they’re in really good shape after two years,” said Dr. Olson-Kennedy, who runs the country’s largest youth gender clinic at the Children’s Hospital of Los Angeles.That conclusion seemed to contradict an earlier description of the group, in which Dr. Olson-Kennedy and her colleagues noted that one quarter of the adolescents were depressed or suicidal before treatment.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.

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When Democrats and Republicans Marry, Debates Ensue

For some politically opposed couples, the election can’t end soon enough.In the 2024 presidential election, Karl Lenker is voting for former President Donald J. Trump. His girlfriend of a decade, Jan Lewin, is voting for Vice President Kamala Harris.So Ms. Lewin, 67, did not appreciate the Biden-Harris “Dumb and Dumber” mug that her partner bought for his morning coffee. Nor was she a fan of the toilet paper featuring President Biden’s face that he put in the bathroom of their condo in Atlanta. (Ms. Lewin retaliated by swapping it out for Trump-themed toilet paper.)Mr. Lenker, 74, a self-described “libertarian Republican,” does not hold back when it comes to talking politics. He believes Ms. Harris is a puppet being used to push a “liberal left” agenda that he calls “insane.”“Not all Democrats are stupid,” Mr. Lenker said. “But all stupid people vote Democrat.”Ms. Lewin tries not to be baited by Mr. Lenker’s ribbing, but she can be equally blunt: “I try not to attack Trump unless he’s doing something so stupid I can’t help it,” she said.Mr. Lenker and Ms. Lewin aren’t the only couple sparring over political ideology in the run-up to this historically tight presidential election. Recent estimates say about one-third of couples do not share a political affiliation, and for true split-ticket couples (6 percent or fewer marriages are between a Democrat and a Republican) this may be a “precarious moment,” said Cynthia Peacock, an associate professor of communication studies at the University of Alabama who researches politically mismatched relationships.Ms. Peacock’s research has found that people in such relationships tend to report slightly lower levels of relationship satisfaction than those who share the same views as their partner. “Political attitudes, you know, they’re not just like the opinions we have about our favorite movies or foods,” she said. “They’re tied to our morals, to our identity, to things we hold very deeply and personally.”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.

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What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials

Genetic tests showed that certain patients were predisposed to brain injuries if they took the drugs. That information remained secret.By 2021, nearly 2,000 volunteers had answered the call to test an experimental Alzheimer’s drug known as BAN2401. For the drugmaker Eisai, the trial was a shot at a windfall — potentially billions of dollars — for defanging a disease that had confounded researchers for more than a century.To assess the drug’s effectiveness and safety, Eisai sought to include people whose genetic profiles made them especially prone to develop Alzheimer’s. But these same people were also more vulnerable to brain bleeding or swelling if they received the drug.To identify these high-risk volunteers, Eisai told everyone that they would be given a genetic test. But the results, the company added, would remain secret.In all, 274 volunteers joined the trial without Eisai telling them they were at an especially high risk for brain injuries, documents obtained by The New York Times show.One of them was Genevieve Lane, a 79-year-old resident of the Villages in Florida who died in September 2022 after three doses of the drug, her brain riddled with 51 microhemorrhages. An autopsy determined that the drug’s side effects had contributed to her death. Her final hours were spent thrashing so violently that nurses had to tie her down.Another high-risk trial volunteer died, and more than 100 others suffered brain bleeding or swelling. While most of those injuries were mild and asymptomatic, some were serious and life-threatening.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.

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E. Coli Outbreak Linked to McDonald’s Quarter Pounders

The C.D.C. said that nearly 50 people had become ill and one person had died from the deadly bacteria, which the agency tied to an ingredient in one of the fast food chain’s burger items.One person has died and 49 people have become ill from an E. coli outbreak linked to McDonald’s Quarter Pounder hamburgers, the Centers for Disease Control and Prevention said on Tuesday.McDonald’s has now stopped selling Quarter Pounders from locations in several states, mostly in the Mountain West, the C.D.C. said, and has also discontinued the use of slivered onions in all sandwiches in those states as health investigators try to determine which ingredient may be contaminated with the deadly bacteria.The public health agency called the situation “a fast-moving outbreak investigation” in its news release.The same strain of bacteria has sickened 49 dozens of people in 10 states, although the C.D.C. said most people were from Colorado and Nebraska. One Colorado resident has died. Ten people were hospitalized, including a child who the health agency said has a complicating illness.All of those interviewed said they had eaten at McDonald’s recently, and most said they had consumed Quarter Pounders. The fast-food chain told investigators it mainly uses fresh onion slivers on that item.Food and health investigators are also trying to determine whether any contaminated beef has been sold to other retailers or grocery stores.This is a developing story.

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FDA Names a New Chief of Medical Devices

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.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.

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New Stroke Recommendations Call Out Risks Unique to Women

In a first, the guidelines link poor pregnancy outcomes to stroke and call on doctors to exercise greater vigilance.New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.“Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.“Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.A stroke is a sudden blockage of blood flow to the brain, or sudden bleeding in the brain. It is a leading cause of the death in the United States, and the incidence has been rising even among adults 49 and younger, stoked by increases in obesity, high cholesterol, diabetes and — perhaps most significantly — high blood pressure.Nearly 800,000 strokes occur each year, leading to severe disability and more than 160,000 deaths. Some 57 percent occur in women. At least 60 percent are preventable.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.

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