As Lykos Therapeutics inches closer to a final decision from the FDA on its MDMA drug for PTSD, questions about the ethics and validity of the company's clinical trials intensify.
A US Food and Drug Administration expert panel will meet Tuesday to consider whether to recommend approval of an investigational midomafetamine capsule in combination with psychological intervention for the treatment of
Critics and supporters will converge on the FDA expert panel, which will evaluate the scientific evidence. If approved, MDMA-AT would be the first psychedelic-based therapeutic cleared by the FDA for any condition in the US and the first PTSD medication to receive approval in 24 years. Patented by Merck in 1914, MDMA was never formally studied but was used by psychiatrists and therapists over the years. It became a popular street drug in the 1980s, known as"ecstasy" or"molly.
"Lots of people, including clinical experts, separate from any of the concerned citizens who might have talked to us on this report, raised concerns about bias," Rind said. And 40% of the trial participants had prior exposure to MDMA, he added. Unethical conduct was also cited by the ICER report authors who noted that"sexual boundaries were severely crossed with at least one patient in a phase 2 trial." , including that MAPS board chair Vicky Dulai"was part of a community of MAPS associates" that exploited"psychedelics' known ability to increase vulnerability to 'love bombing' and other forms of psychological manipulation" to swindle money from wealthy patients.
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