Research on MDMA has shown it can be effective for PTSD, but approval of the treatment isn’t yet guaranteed. In a matter of months, the Food and Drug Administration is expected to decide whether the drug commonly known as ecstasy can be used as a treatment for post-traumatic stress disorder.
An approval by the agency would represent an enormous milestone for the movement to bring psychedelics into the mainstream of mental health care. An FDA rejection of MDMA, the abbreviation of the drug’s chemical name, would deal a major setback to the effort.
Clinical trials have inspired optimism in the drug for its potential to help the millions of Americans who experience PTSD. Accounts from some of those who’ve participated in the trials describe the treatment as transformational.
But new and troubling questions about this research are now threatening to upset the final stretch in the drug’s path to market.
The allegations surfaced in a draft report released in March by the Institute for Clinical and Economic Review , a nonprofit that evaluates clinical trials and drug prices, which found "substantial concerns about the validity of the results" of the MDMA clinical trials.
The ICER report was followed in April by a citizen petition to the FDA. In that document, a group of concerned people allege possible misconduct and ethical violations that could compromise the MDMA research. The petition asked the agency to hold a public meeting to address the concerns.
If true, the claims could jeopardize the drug’s chances of receiving FDA approval, a decision that is expected to come by early August .
"There’s the possibility that the data might not be representative of what’s actually happened in clinical trials," says Neşe Devenot , one of the authors of the citizen petition and a senior lecturer in the writing program at Johns Hopkins University who is involved in psychedelic research. "I don’t think this has been publicly reckoned with."
That may soon happen. The FDA announced Thursday that it plans to hold a public advisory committee meeting on MDMA-assisted therapy on June 4.At the heart of the controversy are the organizations that have pioneered research […]
Transformation or trouble? Research into MDMA plagued with allegations of misconduct
