Alexander Neumeister, M.D., former head of the molecular imaging program at New York University (NYU) School of Medicine, conducted psychiatric research without providing appropriate oversight, states a Feb. 6 warning letter issued by the Food and Drug Administration (FDA), which cited a host of problems uncovered in two protocols during an inspection from July 16-Aug. 5 of last year. Among the issues were falsification of records and failure to confirm “the accuracy of a diagnosis for 13 of the 14 enrolled subjects.”
The industry-sponsored research involved subjects with post-traumatic stress disorder, according to an investigation by The New York Times (NYT), which quoted Charles Marmar, chairman of the psychiatry department, who confirmed that Neumeister had resigned as a result of the issues and that a total of eight psychiatric trials were terminated. Neumeister’s attorney told the NYT there was a difference of opinion as to the seriousness of the problems. Both Marmar and Neumeister’s attorney said no subjects were harmed, according to the NYT. The publication also interviewed a female participant who blogged about her experiences, including having to stop her medications five times due to “false starts” of the research.
Link to NYT article: http://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html
Link to warning letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm493086.htm