HEALTH: Ecstasy Drug Trials Missed Suicidal Thoughts of Subjects.

Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias.

The Food and Drug Administration is expected within days to decide whether to approve the drug, known as MDMA, for treatment of post-traumatic stress disorder. Approval would be a milestone in decades of efforts to decriminalize the use of psychedelics.

Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results.

The study subjects said they felt pressure to report positive outcomes, because that would lead to a history-making drug approval. They also said they could tell they had taken ecstasy during the studies, though gold-standard drug trials are supposed to mask whether a subject got the drug candidate or a placebo.

“I wanted the miracle cure,” said Sarah McNamee, one of the subjects. She said the therapists conducting the trial did, too. “My therapists made it really clear that they really really believed in this thing.”

Lykos Therapeutics, the company sponsoring the studies, recruited researchers conducting the testing from the ranks of therapists who had given ecstasy illicitly and advocated for the drug’s use, according to people familiar with the matter.

Earlier studies had shown some promise for treating PTSD with MDMA so it’s a shame it didn’t pan out — and even worse, if this report is correct, that Lykos skewed their own study to death.