Jul 04, 2016 07:22 AM EDT
New York University Puts A Lid On Drug Study For Post-Traumatic Stress Citing Falsified Records!
New York University's medical school has put the lid on psychiatric studies encompassing an empirical mind-altering drug citing protocol violations, officials said.
Eight studies, many of which centered on mentally ill subjects, were put on the shelf citing violations such as falsification of records and lax oversight, were found by investigators for the Federal Drug Administration, the New York Times reported.
After been suspended by NYU, head researcher, Dr. Alexander Neumeister later resigned.
As far as the data is concerned, it was destroyed. The school also got in touch with the subjects in order to check on their health. It was found that none of them had been harmed, the university divulged.
One of the studies was examining a Pfizer-made drug that was meant to simulate the effects of marijuana to figure out if it lessened syndromes of post-traumatic stress caused by childhood abuse, International Business Times reported.
The aforementioned study not only puts the safety and welfare of the subject in jeopardy, but also raises concerns regarding the genuineness and completeness of the data collected, the FDA explained in a letter to Neumeister.
Following staff members' reports indicating that the research was not corresponding to the standard, medical school officials initiated an analysis of the experiments. According to Psychiatry department chairman Dr Charles Marmar, NYU placed Neumeister on leave and terminated all activities as well as access to all accounts. Marmar took control of those studies.
Closing down the studies is a huge disappointment in what looked like a quantum leap in treating post-traumatic stress disorder, especially for an increasing number of military veterans. However, such studies pose a high degree of risk, especially when dealing with individuals suffering from mental disorders if protocols aren't stringently followed.
The Pfizer Neumister-funded research intended to find out if a cannabis-like drug manufactured by the company could actually abate the syndromes of post traumatic stress. Many of those suffering with the disorder noted some sort of relief with cannabis. Subjects were either assigned a placebo or varied lengths of time to down the Pfizer drug, followed by scans to track down any difference.
Researchers failed to check at least three subjects 24 hours prior to taking the experimental drug, a conceivably dangerous neglect and definitely not in line with the study protocol, FDA officials said.
But that's not all. They also held Neumeister for questioning in regard to falsifying records by singing another researcher's name. The FDA also discovered that the researchers were unable to keep correct case histories.
Moreover, subjects were urged to discontinue any other medication prior to starting the experiment, which presented its own challenges.
Although a Pfizer spokesman noted that an earlier test of the drug used in the New York University study showed no serious side effect, a separate inhibitor (BIA 10‐2474) of the FAAH enzyme made by Bial was associated last year with a death in a French study.
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