New York University’s medical school has quietly shut down eight studies at its prominent psychiatric research center and parted ways with a top researcher after discovering a series of violations in a study of an experimental, mind-altering drug.

A subsequent federal investigation found lax oversight of study participants, most of whom had serious mental issues. The Food and Drug Administration investigators also found that records had been falsified and researchers had failed to keep accurate case histories.

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder, which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.
At least one trial of marijuana, and one using ecstasy, are in the works for traumatized veterans, and some psychiatrists and many patients see this work as having enormous promise to reshape and improve treatment for trauma. But obtaining approval to use the drugs in experiments is still politically sensitive. Doctors who have done studies with these drugs say that their uncertain effects on traumatic memory make close supervision during treatment essential. The violations “jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,” the F.D.A. said in a letter, obtained by The Times, to Dr. Alexander Neumeister, the studies’ lead investigator. The university said there was no evidence that any study participant had been harmed.
From The New York Times, June 28, 2016