US Approved Device for Battlefield Injuries Despite Serious Risks, Former FDA Reviewer Says
Robert Lee, who spent 10 years at the FDA, said agency reviewers were pressured to approve Humacyte Inc.'s Symvess even after he says he repeatedly raised concerns with senior FDA leadership and asked them to hold a public advisory panel meeting of outside experts to discuss the risks and benefits of the product.
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The Food and Drug Administration has approved a weight loss drug called Wegovy for a liver disease, the agency announced on Aug. 18. Wegovy is now approved for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that impacts approximately 6 percent of American adults, the FDA said in a statement.
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Novo Nordisk's Weight-Loss Drug Wegovy Approved to Treat Liver Disease
Key Takeaways Novo Nordisk's blockbuster weight-loss drug, Wegovy, received Food and Drug Administration approval to treat a serious disease of the liver. Wegovy can be used for patients suffering from noncirrhotic metabolic dysfunction-associated steatohepatitis, or MASH. The company said MASH affects one in three overweight or obese people, including 22 million in the U.S. U.S.-listed shares of Novo Nordisk (NVO) gained 4% in premarket trading after the Food and Drug Administration (FDA) approved the pharmaceutical firm's popular weight-loss drug, Wegovy, to treat a serious liver disease. The Denmark-based firm reported the FDA said Wegovy could be used for adults suffering from noncirrhotic metabolic dysfunction-associated steatohepatitis, or MASH, who have moderate to advanced liver fibrosis, along with eating less and exercising more. Novo Nordisk Chief Scientific Officer Martin Holst Lange noted that the decision means Wegovy is the only GLP-1 obesity medicine that has received regulatory approval to treat MASH. He explained that one in three overweight or obese people suffer from it, with some 22 million Americans among them. He added that Wegovy not only stopped the disease activity, it also reversed liver damage. The company announced that Wegovy would be available immediately in the U.S. for the treatment of MASH. The approval is welcome news to Novo Nordisk investors, who have seen the U.S.-listed shares slump as competition from others in the weight-loss category has siphoned away sales of Wegovy. At the close of trading Friday, the shares were down nearly 40% year-to-date. Read the original article on Investopedia
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HHS embraces AI
EXAM ROOM The Department of Health and Human Services has emerged as the leader in artificial intelligence use among all federal agencies. In 2024, HHS reported 116 different ways to use AI for generating content and responses — up from just seven the year before, according to a report from the Government Accountability Office, which monitors agencies for Congress. The GAO reported 271 different AI tools in use last year. A recent analysis by the Bipartisan Policy Center, a think tank in Washington, reveals how three HHS agencies have implemented AI. Notably, they're largely using chatbots to help them work more efficiently. The Centers for Disease Control and Prevention: In 2023, the CDC launched ChatCDC, a bot built on OpenAI's large language models that can summarize meeting minutes, internal documents and studies. It also uses the bot to write code for data analysis. The CDC is experimenting with an updated version that uses more internal documents, but as of January, it hadn't yet been released. The Food and Drug Administration: The FDA has launched a chatbot to help staff respond to emails, summarize meeting minutes and perform a wide variety of basic tasks. While FDA Commissioner Marty Makary has promised faster regulatory review turnaround, staff have argued that the tool is prone to mistakes and incapable of assisting with the review process. The FDA has also experimented with using AI for an array of tasks, including labeling drugs and looking for data patterns and anomalies. The Centers for Medicare and Medicaid Services: CMS uses AI to prevent and detect fraud, waste and abuse and analyze prescription drug costs. The takeaway: HHS continues to lead the way for AI use. Health Secretary Robert F. Kennedy Jr. has said he sees digital technology and AI as key tools for improving health care outcomes and reducing costs. WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. Sen. Marsha Blackburn (R-Tenn.) is calling for an investigation into Meta following reporting that the company allowed its chatbots to 'engage a child in conversations that are romantic or sensual.' Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: CarmenP.82, RuthReader.02 or ErinSchumaker.01. INFLUENCERS A newly launched psychedelic medicine foundation wants to become the 'American Cancer Society of ibogaine access.' Mission Within Foundation, which officially launched today, plans to use the $2 million in funding it has secured from private donors and foundations to promote the psychedelic drug ibogaine, derived from an African shrub, as a mental health treatment. The Drug Enforcement Administration classifies ibogaine as a Schedule I drug with no currently acceptable medical use and a high risk of abuse. It can pose heart risks and has been linked to about two dozen deaths in recent decades. The foundation plans to lobby for safe and legal access to ibogaine treatment in the U.S. and offer fully funded psychedelic therapy retreats to veterans and frontline workers with post-traumatic stress disorder, traumatic brain injuries, depression and addiction. It will also team up with the Dell Medical School at the University of Texas on three ibogaine research studies. Who's who: Dr. Martín Polanco, who runs The Mission Within, a psychedelic medicine clinic in Tijuana, Mexico, is one of the foundation's founders. He's treated more than 5,000 people with traumatic brain injuries and mental health conditions like PTSD, including many veterans, using ibogaine and the psychedelic drug 5-MeO-DMT, a desert toad secretion. Polanco has the ear of Reps. Jack Bergman (R-Mich.) and Lou Correa (D-Calif.), co-founders of the Congressional Psychedelics Advancing Therapies Caucus, who've been working in Washington to advance psychedelic medicine. Correa traveled to Polanco's clinic in Tijuana last year to talk with him in person and see whether his work justified further research on the drugs in the U.S. The foundation, which is also advocating for psychedelic medicine more broadly, is supporting Correa and Bergman's Innovative Therapies Centers of Excellence Act, which the pair introduced in April. The bill seeks $30 million for Veterans Affairs Department research on psychedelic therapies and would create five centers of excellence to research alternative treatments for veterans. What's next: Texas Gov. Greg Abbott, a Republican, signed a law in June putting $50 million in state funding toward clinical trials of ibogaine as a mental health treatment. And the state budget Arizona's Democratic governor, Katie Hobbs, signed into law the same month included a commitment of $5 million for studying ibogaine. Mississippi plans to hold a joint hearing of the House and Senate Public Health and Human Services committees on ibogaine on August 28.
