Three MDMA Studies Are Retracted by Scientific Journal

The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place.Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. In declining to approve Lykos’s application, the agency cited concerns about missing data and problems with the way the company’s study was designed, according to a statement released by Lykos on Friday.The F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.The journal retraction was first reported by Stat, the health and medical news website.On Sunday, Lykos said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications.“The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said in the statement.The incident cited by Psychopharmacology has been well documented. In 2015, an unlicensed Canadian therapist who took part in the trial engaged in a sexual relationship with a participant after the conclusion of the trial’s dosing sessionsIn civil court documents, the patient, Meaghan Buisson, said she was sexually assaulted by the therapist, Richard Yensen, who at the time was working alongside his wife, a licensed therapist. Mr. Yensen has said the relationship was consensual and initiated by Ms. Buisson. Six months after the final session, she moved from Vancouver to Cortes Island, in British Columbia, where the couple lived, according to court documents. The relationship between patient and practitioner continued for more than a year, the documents said. Professional associations in both Canada and the United States prohibit sexual relationships between psychologists and patients for at least two years after their final session. The incident helped highlight some of the challenges associated with psychedelic medicine, which can render patients especially vulnerable during dosing sessions. For that reason, most clinical trials involving psychedelic compounds require the presence of two mental health professionals. (Lykos’s trials with MDMA require only one of the practitioners to be licensed.)The Multidisciplinary Association for Psychedelic Studies, or MAPS, is the nonprofit that carried out the research and later created Lykos to market its proprietary MDMA-assisted therapy. The association publicly acknowledged the incident in 2019, adding that it had been reported to the F.D.A. and to Canadian health authorities.The company acknowledged on Sunday that it had failed to notify Psychopharmacology about the violations, but it said that the oversight should have been addressed through a correction, not a retraction.

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I.V.F. Threats in Alabama Drive Clinics to Ship Out Embryos

An emerging movement against in vitro fertilization is driving some doctors and patients in red states to move or destroy frozen embryos.The embryo migration is most striking in Alabama, where the State Supreme Court ruled in February that embryos were “unborn children.” Since then, at least four of Alabama’s seven fertility clinics have hired biotech companies to move the cells elsewhere. A fifth clinic is working with a doctor in New York to discard embryos because of concerns about the legality of doing so in Alabama.Fertility patients outside of Alabama, too, are worried about how their precious embryos — specks of 70 to 200 cells barely visible to the human eye — might one day be affected by lawmakers who believe human life begins at conception. Since the Supreme Court’s 2022 decision to overturn Roe v. Wade, 14 states have passed total or near total abortion bans. And the Southern Baptists, the country’s largest Protestant denomination, voted in June to oppose I.V.F., calling for the protection of “frozen embryonic human beings.”That month in Texas, Diana Zucknick spent $1,550 to send a tank of liquid nitrogen holding five of her embryos to New York for safekeeping. In South Dakota, Jennifer Zabel destroyed two embryos because she feared the state would take control of them. And in Mississippi, Dr. Preston Parry said more of his fertility patients were choosing to make fewer embryos at a time, prolonging the typical I.V.F. process in order to minimize leftover embryos.While there is no official tally of the number of frozen embryos in the United States, experts estimate it’s in the millions. And many clinics are overwhelmed by a mounting inventory of cells that are sometimes years or even decades old.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 Killed Harmony Ball-Stribling?

The last day Byron Stribling spent with his wife, Harmony, was the Fourth of July in 2021. A great day, he always says.The holiday fell on a Sunday. The congregation at their church in Belzoni, a small town in the Mississippi Delta, blessed the couple and prayed for a safe delivery for Ms. Ball-Stribling. She was eight months pregnant and scheduled to have a C-section five days later.At a barbecue, the Striblings feasted on ribs, collard greens, potato salad and cornbread. But around midnight, Ms. Ball-Stribling threw up and said her chest hurt. “She wanted to lay down, but I told her, ‘We need to go somewhere,’” Mr. Stribling, 32, recalled.Ambulances in the Delta are unreliable, and the only hospital in Belzoni closed over a decade ago. So they piled into his car and sped toward Yazoo City, Miss., the closest town with an emergency room, about 30 miles away.On the way, Ms. Ball-Stribling had a seizure. Panicked, Mr. Stribling called 911. The dispatcher told Mr. Stribling to pull over and start CPR, so he slammed on the brakes and pumped her chest on the side of the road until an ambulance came. But he already knew he had lost her, there on the shoulder of Route 49-W.What killed Harmony Ball-Stribling? The death certificate says the cause of death was complications of pre-eclampsia, a life-threatening blood pressure disorder that can develop during pregnancy, exacerbated by hypertension and hardening of the arteries. But that’s not the whole story.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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F.D.A. Declines to Approve MDMA Therapy, Seeking More Study

The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy, according to the company seeking approval.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dashing the hopes of many Americans with intractable mental health conditions who are desperate for new treatments.According to Lykos Therapeutics, the company that had sought approval for the treatment, the agency said there was insufficient data to allow its use. The company said that the F.D.A is requesting an additional clinical trial, to continue to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.Had it been approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities.Outright approval by the F.D.A. would have been a watershed moment in the decades-long effort by researchers to demonstrate the healing potential of compounds like LSD and psilocybin, the psychoactive component of so-called magic mushrooms.“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 rejected the company’s application. With regard to two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that its benefits did not outweigh the risks.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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Howie Cohen, Whose Alka-Seltzer Ads Spawned Catchphrases, Dies at 81

A copywriter, he and a partner in 1972 came up with “Try it, you’ll like it” and “I can’t believe I ate that whole thing.” Soon, sales were, well, fizzing.Howie Cohen, an advertising copywriter, often said he was congenitally familiar with indigestion. So perhaps it was only natural that in the 1970s, he, along with an ad agency colleague, would conjure up a catchy slogan that would not only sell more Alka-Seltzer but also become an American pop culture punchline: “I can’t believe I ate the whole thing.”That bedside lament, spoken by the comedian and dialectician Milt Moss — he actually said that thing on camera — vaulted from a 30-second TV commercial to sweatshirts, supermarket windows and even church marquees.It proved even more popular than “Try it, you’ll like it,” the first catchphrase for Alka-Seltzer that Mr. Cohen coined with his business partner, Bob Pasqualina, an art director at the Manhattan agency Wells Rich Greene.Mr. Cohen, who helped popularize products and companies like Petco (“Where the pets go”) and the fast-food chain Jack in the Box (exploding its clown mascot in a TV commercial in announcing a new, more sophisticated menu), died on March 2 at his home in Los Angeles. He was 81.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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J. Robin Warren, Who Proved That Bacteria Cause Ulcers, Dies at 87

He endured skepticism but won a Nobel Prize for his work upending the conventional wisdom that stress, diet or alcohol caused the painful condition.Dr. J. Robin Warren, the Australian pathologist who shared a Nobel Prize for discovering that most stomach ulcers were caused by the bacterium Helicobacter pylori — and not, as had been widely believed, stress, alcohol or spicy foods — died on July 23 in Inglewood, Australia. He was 87.His death, at a care home, was announced by the University of Western Australia in Perth, where he was an emeritus professor for many years. His daughter-in-law Gigi Warren said the cause was complications after a recent fall.In 1984, Dr. Warren and his collaborator, the gastroenterologist Barry Marshall, published a paper in the British medical journal The Lancet describing their finding that the spiral-shaped bacterium now commonly called H. pylori festered in the stomachs of patients with ulcers and gastritis. Dr. Warren had first noticed the bacterium on a gastric biopsy sample in 1979.The paper’s conclusion upended centuries of conventional wisdom about the cause of ulcers. (Psychoanalysts had even written of the “peptic ulcer personality.”) Doctors typically prescribed stress reduction, a bland diet and, starting in 1977, drugs like Tagamet and Zantac to tame the burning acids. Severe cases were sometimes treated with surgery.Dr. Warren, right, with the gastroenterologist Barry Marshall in 1984. When their study of ulcers was published, gastroenterologists expressed concern about whether to trust potentially paradigm-shifting findings made by two unknown researchers in Australia.University of Western AustraliaWhen the study was published, gastroenterologists were skeptical. They expressed concern about whether to trust potentially paradigm-shifting findings made by two unknown researchers in Australia. And the idea that bacteria could even grow in the stomach was considered blasphemy.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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Childhood Vaccines Aren’t Just Saving Lives. They’re Saving Money.

Over the past three decades, routine immunizations have prevented 1.1 million deaths and saved the United States $540 billion, the C.D.C. estimated.There’s no way to put a price on the pain and suffering prevented by childhood vaccines. But as it turns out, you can pinpoint the savings to the country.For nearly three decades, childhood vaccines — including those that target measles, tetanus and diphtheria — have saved the United States $540 billion in health care costs, according to a new report from the Centers for Disease Control and Prevention.Routine childhood vaccinations have prevented approximately 508 million cases of illness, 32 million hospitalizations and 1,129,000 deaths, the agency estimated on Thursday.“These vaccine programs, when you create the right infrastructure to implement them, they pay for themselves right away,” said William Padula, a health economist at the University of Southern California who was not involved in the new research.The savings estimate includes money that would have been spent on treating the initial infection and managing later, related conditions. The figure dwarfs the cost of developing the shots.But vaccine-preventable illnesses can also cause indirect economic effects if children become permanently disabled from an infection, or parents miss work while caring for their sick children.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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