Several NYU medical studies shut down in the face of violations
Eight studies conducted at the New York University (NYU) School of Medicine have been shut down following an investigation by the US Food and Drug Administration (FDA). The principle investigator of the trials, Dr. Alexander Neumeister, has also been placed on leave from the university. The FDA investigation found several violations of research regulations, including falsified documents and poor record-keeping regarding case histories, as well as violations of protocol, including lack of follow up and allowing multiple investigational new drugs (IND) to be administered in too short a time frame (Carey, 2016).
The studies were an effort to understand how an IND influences the treatment of psychological trauma (Grant, 2016). This particular IND was a fatty acid amide hydrolase (FAAH), which is meant to mimic the effects of marijuana. Dr. Neumeister had previously led a study that looked at the effect of cannabis on patients with post-traumatic stress disorder (PTSD). In a media release from 2014 regarding this preliminary trial, he stated that it is well known that “people with PTSD who use marijuana often experience more relief from their symptoms than they do from antidepressants and other psychiatric medication” (Carey, 2016).
This case is particularly sensitive due to the fact that the studies involved participants with mental disorders. These people are considered to be a vulnerable population in regard to the research process. Extra precautions must be taken in order to ensure their rights are maintained and their health protected. The executive director of Public Responsibility in Medicine and Research, Elisa Hurley, discussed how extra vigilance is needed for studies like these.
George Lederman, attorney to Dr. Neumeister, claims that his client’s actions were not illegal, and instead were “deviations from the protocol that were inconsistent with regulations” put in place by the FDA (Sonenshine, 2016). He also notes that these small mistakes could have been easily fixed, and did not prompt the sponsor and funder, Pfizer, to shut down the studies (Carey, 2016). Both parties maintain that no study participant has been harmed; however, the university continues to disagree with Dr. Neumeister on the seriousness of his violations.
Carey, B. (June 27, 2016). An N.Y.U. Study Gone Wrong, and a Top Researcher Dismissed. The New York Times. Retrieved from http://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html
Grant, B. (June 28, 2016). NYU Halts Studies, Suspends Investigator. The Scientist. Retrieved from http://www.the-scientist.com/?articles.view/articleNo/46439/title/NYU-Halts-Studies--Suspends-Investigator/
Sonenshine, J. (July 11, 2016). How a medical study on PTSD at NYU went wrong. USA TODAY College. Retrieved from http://college.usatoday.com/2016/07/11/how-a-medical-study-on-ptsd-at-nyu-went-wrong/