New York University's medical school has pulled the plug on psychiatric studies involving an experimental mind-altering drug, because of protocol violations, according to officials.
Eight studies, many involving mentally ill subjects, were suspended as violations, including lax oversight and falsification of records, were discovered by investigators for the Federal Drug Administration, the New York Times reported.
Head researcher, Dr. Alexander Neumeister, was suspended by NYU and later resigned. All data was destroyed and subjects have been contacted to check on their health, according to the school. There was no indication any of the test subjects had been harmed, according to the university.
One of the studies was testing a drug manufactured by Pfizer — an FAAH inhibitor — intended to mimic the effects of marijuana to determine if it relieved symptoms of post-traumatic stress caused by childhood abuse.
The study violations "jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected," the FDA said in a letter to Neumeister.
Medical school officials began to scrutinise the experiments after staff members expressed concern that the research was not conforming to standards. Psychiatry department chairman Dr Charles Marmar told the New York Times that the university placed Neumeister on leave "and suspended all activity, suspended access to all accounts. I took control of those studies."
A lawyer for Neumeister said there may have been protocol violations but that NYU believes the violations were "more egregious than we believe they actually were."
Shutting down the studies is a setback in hoped-for breakthroughs in treatment of post-traumatic stress disorder, particularly for a growing number of military veterans. But such studies, particularly when they deal with people suffering from mental disorders, present a high degree of risk to subjects if protocols aren't strictly followed.
In the study funded by Pfizer Neumister hoped to determine if a cannabis-like drug made by the company could ease the symptoms of post traumatic stress; many sufferers with the disorder have reported finding some relief with cannabis. Subjects were assigned a placebo or different lengths of time to take the Pfizer drug, followed by brain scans to detect any changes.
Researchers failed to assess at least three subjects 24 hours after taking the experimental drug, a potentially risky oversight and contrary to study protocol, according to FDA officials. They also accused Neumeister of falsifying documents by signing another researcher's name. The FDA also found that researchers failed to keep accurate case histories.
Subjects were told to stop any other medications before starting the experiment, which presented its own problems.
"It was horrible," one subject told the newspaper. "I had flashbacks, returning nightmares, every symptom coming on full force, not to mention the withdrawal. After going off and back on four or five times, I told them, 'I can't do this anymore.'"
Though a Pfizer spokesman said a previous test of the drug used in the NYU study turned up no significant side effect, another inhibitor (BIA 10‐2474) of the FAAH enzyme manufactured by Bial was linked in late 2015 to a death in a French study.