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Around the nation: FDA rejects MDMA therapy to treat PTSD


FDA last week declined to approve MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD), citing insufficient data to support its use, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and North Carolina. 

  • District of Columbia: Last week, the Red Cross announced that it is experiencing an emergency blood shortage. Since July 1, the organization said that its national blood inventory decreased by more than 25%. According to the Red Cross, extreme heat waves across the country may have impacted more than 100 blood drives over the last month. Due to high temperatures, some drives have had to end early or be cancelled. Fewer people have donated overall, which led to a shortfall of over 19,000 donations in July. The Red Cross also said that it believes there will be difficulty replenishing the available blood supply in August due to the start of the Atlantic hurricane season, which can lead to flooding and power outages that cancel blood drives and contribute to low donor turnout. "When we start to have a shortfall in donations that has a really significant impact," said Baia Lasky, the Red Cross's division CMO. "This time of year is challenging for us. The demand for blood is constant throughout the year whether [it's] trauma patients, cancer patients." (Kekatos, ABC News, 8/5)
  • Maryland: FDA last week declined to approve MDMA-assisted therapy to treat PTSD, citing insufficient data to support its use. Previously, an FDA advisory panel voted 9-2 against recommending MDMA's effectiveness to treat PTSD and 10-1 against whether the benefits of the drug outweighed its risks. According to the New York Times, FDA has asked Lykos Therapeutics, the company seeking approval for MDMA-assisted therapy, to conduct another clinical trial to assess its safety and efficacy. However, another clinical trial could cost millions of dollars and add years to the treatment's potential approval. In a statement, Lykos said it plans to appeal FDA's decision. "The F.D.A. request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Lykos CEO Amy Emerson. Although FDA declined to discuss its decision, a spokesperson said that "the agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD." (Jacobs, New York Times, 8/9; Lovelace, NBC News, 8/9; Stone, "Shots," NPR, 8/9)
  • North Carolina: CMS last month approved a North Carolina plan to give hospitals additional Medicaid funds if they forgive medical debt for approximately 2 million residents. The plan would cover Medicaid recipients, people who are not enrolled in Medicaid and have incomes that are at or below at least 350% of the federal poverty level, or those whose total debt is greater than 5% of their annual income. Hospitals that received additional funds would also have to discount medical bills on a sliding scale for patients whose incomes are at or below 300% of the federal poverty level. Hospitals would also have to automatically enroll people into financial assistance, or charity care. According to North Carolina Gov. Roy Cooper (D), the plan could relieve up to $4 billion in existing medical debt that dates back to 2014. (Bettelheim, Axios, 7/31)

Cheat sheet: Psychedelic-assisted therapy

Learn how psychedelic-assisted therapy is disrupting care delivery and generating evidence to change clinical practice.


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