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Health Care |
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FDA denies approval of MDMA therapy |
The Food and Drug Administration on Friday denied approval to an MDMA-based treatment for post-traumatic stress disorder (PTSD), a major setback for the use of psychedelic drugs as medicine. |
The decision generated an enormous amount of lobbying from bipartisan lawmakers, veterans' groups and other advocates. The FDA has not approved any new treatments for PTSD in more than two decades, and proponents have said continued high rates of veteran suicides means the government must do more to protect veterans. The treatment from the drug company Lykos Therapeutics paired MDMA with talk therapy. The decision marked the first time the U.S. has considered a Schedule I drug — those believed to have a high potential for abuse such as heroin and LSD — for medical use. More than 13 million individuals in the U.S. live with PTSD, and veterans are disproportionately affected, according to estimates from the National Center for PTSD. But current treatments are notoriously not very effective. According to the most recent study, 71 percent of people who used the treatment experienced enough improvement in their symptoms that they no longer qualified as having PTSD. But critics called into question the quality of the data surrounding the company's clinical trials, and FDA's panel of independent advisers overwhelmingly recommended rejecting the application. Lykos said FDA has requested an additional Phase 3 trial to further study the safety and efficacy of the treatment, but such studies often take years and cost millions of dollars to perform. The company said it plans to request a meeting with the FDA to ask for reconsideration. |
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How policy will be impacting the health care sector this week and beyond: |
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A federal judge ruled Friday that the U.S. Centers for Disease Control and Prevention (CDC) has likely been breaking federal law by deleting former employees’ emails soon after they leave the agency. The ruling was issued by District Judge Rudolph Contreras on a lawsuit filed by Trump-aligned conservative group America First Legal Foundation in April. Contreras found that the CDC was following a records-retention … |
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A federal judge is expected to soon decide whether Alabama can prosecute health care providers and advocates in the state who help pregnant patients get an abortion elsewhere. Abortion has been almost entirely illegal in the ruby red state since its trigger law took effect following the Supreme Court's decision to overturn Roe v. Wade in 2022. It is one of the strictest bans in the country, with no exceptions for rape … |
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A coalition of 15 state attorneys general are suing the Biden administration over its plan to expand Affordable Care Act (ACA) health coverage to immigrants brought to the U.S. illegally as children. The states, led by Kansas Attorney General Kris Kobach (R), want to stop the administration's plan from taking effect Nov. 1. Under the rule, active recipients of Deferred Action for Childhood Arrivals (DACA) will be … |
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Branch out with a different read: |
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A COVID-19 outbreak has emerged at the 2024 Olympics in Paris, and at least 40 athletes tested positive, including U.S. track star Noah Lyles. |
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Local and state headlines on health care: |
- JD Vance's stance on recreational marijuana is at odds with Donald Trump's view (WOSU)
- As opioid deaths plague Baltimore, the city's strategy is silence (Baltimore Banner)
- A mother spent months trying to get her son's full Medicaid back, then asked a lawmaker for help (Florida Phoenix)
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Health news we've flagged from other outlets: |
- How little Denmark got homegrown giant Novo Nordisk to lower Ozempic prices (KFF Health News)
- Why Trump's mifepristone comments were a gift to the Harris campaign (Stat)
- Childhood vaccines aren't just saving lives. They're saving money (The New York Times)
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Most read stories on The Hill right now: |
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Veterans in Congress are taking sides in the battle over the military record of Minnesota Gov. Tim Walz (D), who was recently accused of "stolen valor" … Read more |
| Former President Trump tried to seize back the headlines and curb Vice President Harris's election momentum Thursday with a long and characteristically … Read more |
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