Sarepta will resume gene therapy shipments after FDA review of recent patient death
The Food and Drug Administration said it recommended lifting the hold for young patients with Duchenne's muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of two older teenagers who were taking the therapy. The FDA also said in a statement it determined that a recently reported death of an 8-year-old boy was unrelated to the therapy.
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Winnipeg Free Press
9 hours ago
- Winnipeg Free Press
California governor signs executive order to support boys and men and improve their mental health
SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom signed an executive order Wednesday aimed at supporting men and boys and improving their mental health outcomes, in an effort to lower suicide rates among young men and help them feel less isolated. The order directs the state Health and Human Services Agency to recommend ways to address suicide rates among young men and help them seek services to improve their mental health and well-being. It also requires the state to connect them with education and career opportunities. 'Too many young men and boys are suffering in silence — disconnected from community, opportunity, and even their own families,' Newsom, a Democrat, said in a statement. 'This action is about turning that around. It's about showing every young man that he matters and there's a path for him of purpose, dignity, work, and real connection.' The issue has come increasingly into focus for Democrats since last year's election, when the party lost young men to President Donald Trump, who framed much of his campaign as a pitch to men who felt scorned by the country's economy, culture and political system. More than half men under 30 supported Trump, according to AP VoteCast, a survey of more than 120,000 voters, while Democrat Joe Biden had won a similar share of that group four years earlier. Newsom, a possible 2028 presidential candidate, has talked about the need to support men and boys on his podcast. The majority of his guests, which have included MAGA figures, Democratic politicians and book authors, have been men. He released an episode Wednesday with Richard Reeves, the founder and president of the American Institute for Boys and Men, a group that researches issues affecting the well-being of men, to discuss what can be done to better meet their needs. Newsom said at the beginning of the episode that it's an important issue to address beyond just discussing it as a political hurdle for Democrats. 'If you tune into the podcast, you may have noticed a theme — a theme that continues to emerge around men and boys,' Newsom said. 'What is going on with our men and boys? Increasingly isolated, increasingly feeling disengaged, disconnected, depressed.' Newsom's order requires the state to try to get more men and boys to serve their communities through volunteer programs and support pathways to help more male students become teachers and school counselors. State agencies must also recommend ways to get more young men to participate in state career education and training programs, as well as an initiative to help improve student outcomes. Officials must provide an update within two months. Men make up half the population but account for 80% of suicides in the U.S., according to the Centers for Disease Control and Prevention. The U.S. suicide mortality rate — defined as deaths per 100,000 people — for men and boys in 2023 was 22.7, about four times higher than that of women and girls, according to the CDC. California had one of the lowest suicide rates in the country in 2023, per the CDC. The suicide mortality rate was about 10.2, compared with a rate of 14.1 in the U.S. overall. ___ Austin is a corps member for The Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues. Follow Austin on X: @sophieadanna
Toronto Star
9 hours ago
- Toronto Star
Dozens killed while seeking food in Gaza as US envoy heads to Israel
DEIR AL-BALAH, Gaza Strip (AP) — At least 48 Palestinians were killed and dozens were wounded on Wednesday while waiting for food at a crossing in the Gaza Strip, according to a local hospital that received the casualties. The latest violence around aid distribution came as the U.S. Mideast envoy was heading to Israel for talks. Israel's ongoing military offensive and blockade have led to the 'worst-case scenario of famine' in the coastal territory of some 2 million Palestinians, according to the leading international authority on hunger crises. A breakdown of law and order has seen aid convoys overwhelmed by desperate crowds.
Winnipeg Free Press
10 hours ago
- Winnipeg Free Press
Ousted vaccine panel members say rigorous science is being abandoned
NEW YORK (AP) — The 17 experts who were ousted from a government vaccine committee last month say they have little faith in what the panel has become, and have outlined possible alternative ways to make U.S. vaccine policy. U.S. Health Secretary Robert F. Kennedy Jr. abruptly fired the entire Advisory Committee on Immunization Practices, accusing them of being too closely aligned with manufacturers and of rubber-stamping vaccines. He handpicked replacements that include several vaccine skeptics. In a commentary published Wednesday in the New England Journal of Medicine, the former panel members wrote that Kennedy — a leading voice in the anti-vaccine movement before becoming the U.S. government's top health official — and his new panel are abandoning rigorous scientific review and open deliberation. That was clear, they said, during the new panel's first meeting, in June. It featured a presentation by an anti-vaccine advocate that warned of dangers about a preservative used in a few flu vaccines, but the committee members didn't hear from Centers for Disease Control and Prevention staffers about an analysis that concluded there was no link between the preservative and neurodevelopmental disorders. The new panel recommended that the preservative, thimerosal, be removed even as some members acknowledged there was no proof it was causing harm. 'That meeting was a travesty, honestly,' said former ACIP member Dr. Yvonne Maldonado, a pediatric infectious diseases expert at Stanford University. The 17 discharged experts last month published a shorter essay in the Journal of the American Medical Association that decried Kennedy's 'destabilizing decisions.' The focus was largely on their termination and on Kennedy's decision in May to stop recommending COVID-19 vaccines for healthy children and pregnant women. In the new commentary, the ousted committee members took it one step further and prescribed some steps that could be taken to maintain scientifically sound vaccine recommendations. 'An alternative to the Committee should be established quickly and — if necessary — independently from the federal government,' they wrote. 'No viable pathway exists to fully replace the prior trusted and unbiased ACIP structure and process. Instead, the alternatives must focus on limiting the damage to vaccination policy in the United States.' Options included having professional organizations working together to harmonize vaccine recommendations or establishing an external auditor of ACIP recommendations. There are huge challenges to the ideas, including having access to the best data, the authors acknowledged. There's also the question of whether health insurers would pay for vaccinations that are recommended by alternative groups but not ACIP. They might pick and choose which vaccines to cover, said the University of North Carolina's Noel Brewer, another former ACIP member. For example, they might pay for vaccines that offer more immediate cost savings for health care, like the flu vaccine. 'But maybe not ones that have a longer-term benefit like HPV vaccine,' which is designed to prevent futures cancers, Brewer said. Officials with the U.S. Department of Health and Human Services did not immediately respond to a request for comment. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
