The Washington Post (8/9, Gilbert , Ovalle , Roubein ) reported that on Friday, the Food and Drug Administration “rejected for now the first attempt to win approval of MDMA to treat post-traumatic stress disorder – a major blow for advocates who for decades have pushed to integrate illegal psychedelic drugs into mainstream medical care.” The agency has “requested another large study, which could take several years to conduct, according to” Lykos Therapeutics. The company “said it plans to contest the FDA’s request, saying it believes the existing data is adequate to prove the drug’s efficacy.”

The New York Times (8/9, Jacobs ) reported that following the FDA’s decision, “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.” The agency “declined to discuss the decision or release the letter it sent to Lykos outlining its reasoning, citing confidentiality rules.” However, an FDA spokesperson said in a statement that the agency “will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.”

The AP (8/9, Perrone ) reported that while disappointing for some, “the FDA’s decision was expected after a panel of government advisors voted overwhelmingly against the drug’s use for post-traumatic stress disorder in June.” The agency “said Friday the MDMA application had ‘significant limitations’ that ‘prevent the agency from concluding that the drug is safe and effective for the proposed indication.’”

Also reporting was Reuters (8/10, Roy, Sunny).

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— “The Washington Post (requires login and subscription)

The New York Times (8/12, Jacobs ) reports, “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.” The conduct in question involved “a sexual relationship” between “an unlicensed Canadian therapist who took part in the trial” and “a participant after the conclusion of the trial’s dosing sessions.” Multiple 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.” While Lykos “said the research in the retracted papers was not part of its application to the F.D.A.,” on Sunday the company “said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics.”

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Healio (8/12, Mahoney) reports, “Suicide rates among U.S. preteens increased significantly from 2008 to 2022, with the greatest increases being among Hispanic preteens and girls, according to a study.” Investigators also observed “the rate of suicide remained highest among Black preteens from both 2001 to 2007 (4.94 per 1 million persons) and 2008 to 2022 (8.5 per 1 million persons).” The findings were published in JAMA Network Open.

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— “Suicide rates rise among preteens, with highest increases seen among Hispanic youth, girls,”Moira Mahoney, Healio, August 12, 2024

The AP (8/11) reports Majority Leader Chuck Schumer (D-NY) “said Sunday he will work to block a plan that would significantly cut the proposed budget of the Centers for Disease Control and Prevention, warning that such a spending reduction could endanger the public.” Senate Democrats “said the proposal in a House bill includes a reduction of the CDC’s proposed budget by $1.8 billion, or about 22%,” which “would mean a major cut in programs designed to address firearm injuries and opioid overdose prevention.” Schumer “said such a reduction ‘would wreak havoc and chaos on food safety funding mechanisms and tracking operations at a core level,’” pointing “specifically to the CDC’s work on the ongoing listeria food poisoning outbreak linked to Boar’s Head deli meats that has killed at least three people and sickened more than 40 others.”

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— “Schumer says he will work to block any effort in the Senate to significantly cut the CDC’s budge, AP, August 11, 2024

The New York Times (8/8, Glover-Smith ) says “a report published last week by an international commission focused on dementia prevention” found that “adults over age 65 who experience vision loss have a nearly 50 percent increased risk of developing dementia.” However, if the “vision problems are corrected, that risk drops dramatically.” The commission also “found that people with hearing loss have a 37 percent increased risk for developing dementia,” with more severe hearing loss leading to a higher risk. The findings led the commission to add “vision impairment to its list of 14 total modifiable risk factors for dementia,” which also includes “smoking, diabetes, social isolation and hypertension.” The report was published in The Lancet.

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— “The New York Times (requires login and subscription)