NYU Drug Studies Shut Down For Violating Safety Regulations

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NYU Drug Studies Shut Down For Violating Safety Regulations

By May Wilkerson 06/30/16

In one of the many violations, the NYU research team failed to evaluate at least three of the 50 subjects 24 hours after they were given an experimental drug. 

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NYU Drug Studies Shut Down For Violating Safety Regulations

New York University’s medical school was forced to shut down eight studies after investigators discovered that the school had committed multiple violations in studying the effects of experimental drugs, according to a report by the New York Times. The FDA found that researchers had kept false records and inaccurate case histories during the studies. And another federal investigation found that researchers had failed to properly oversee study participants, most of whom had serious mental health issues.

The violations “jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,” said a letter from the FDA to the studies’ lead researcher, Dr. Alexander Neumeister.

In one of the studies, which has since been shut down, people diagnosed with PTSD caused by childhood abuse were given a drug meant to mimic the effects of marijuana, to see if it relieved symptoms. “I think their intent was good, and they were considerate to me,” said one of the study participants, 40-year-old Diane Ruffcorn of Seattle, who is a survivor of childhood abuse. “But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.”

The research team went ahead to conduct studies into a synthetic drug meant to imitate some of the effects of marijuana, made by pharmaceutical giant Pfizer, who funded the trial. Fifty participants were recruited, all diagnosed with PTSD, and given either the drug, which is known as an F.A.A.H. inhibitor, or a placebo. The NYU team then performed brain scans and examined the participants for relief of symptoms.

But the FDA and DEA investigations found numerous violations of protocol, including falsification of documents by Dr. Neumeister. Inspectors also found that the research team had failed to assess at least three subjects 24 hours after they had taken the experimental drug, which is a violation of protocol and could put participants at risk. Experts noted that people with mental disorder, like PTSD, are at especially high risk for adverse drug reactions.

Some participants also reported that in preparation for the trial, they were told to stop taking their medications. “It was horrible,” said Ms. Ruffcorn, of going off her meds. “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.’”

According to Dr. Charles Marmar, the chairman of the psychiatry department at NYU, various researchers had complained about violations in the studies, leading to Dr. Neumeister being placed on leave and his work suspended by the administration. He later resigned, and his studies were taken over by Dr. Marmar. Dr. Neumeister’s lawyer claims the violations were not as severe as NYU claims. The university has since thrown out all the data from the studies and followed up with study participants to check on their health, said Dr. Marmar.

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