Advocates have long pushed for the psychedelic drug known as MDMA, ecstasy, or molly to be approved as a prescription drug for those with post-traumatic stress disorder, but the movement suffered a big setback Tuesday. A Food and Drug Administration advisory panel voted—"overwhelmingly," CNN reports—against recommending it for approval as a PTSD treatment. Some salient points from coverage of the move:
- The problem: Drugmaker Lykos Pharmaceuticals presented positive data from two Phase 3 clinical trials, but panelists brought up concerns with inconsistencies, bad study design, and even misconduct allegations, NBC News reports. One big issue: The trials were supposed to be double-blind, but because of the hallucinogenic effects of MDMA, it was pretty easy for participants to tell whether they'd been given that or a placebo. That means the results could have been artificially inflated, panelists said. Also of concern was the fact that some study participants had previously used MDMA, and the FDA also cautioned that the potential for abuse of the drug was not assessed as a possible adverse event were the drug to be approved.
- Historic: FDA advisers have never before considered a Schedule I psychedelic drug for medical use. In addition, no new treatment for PTSD has been approved in more than 20 years.
- Final say? The FDA still has the final say on whether a drug is approved and does not need to follow the recommendation of an independent advisory committee, but the agency typically does follow such recommendations.
- A quote from the minority: "There's no free lunch in medicine," says the one panel member (a psychiatry professor) who voted "yes" on safety and one of two panel members to vote "yes" on efficacy. "What has the potential for benefit has the potential for harm." He adds, "Working in the VA, as a former servicemember myself, I have colleagues who deployed who have PTSD, and this has the potential to make a difference. Now, that's not without its risks."
- A quote from the majority: "The data was promising but given the 40% of people who had previously used MDMA, limited information about recruitment, and recruitment coming through referrals—I really wonder how much that impacted the efficacy" that was reported, says another panelist.
A final ruling from the FDA is expected by August 11. (More
MDMA stories.)
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