As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence

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,.