July 5, 2016

A Top N.Y.U. Researcher Dismissed from Research Study

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