New York University has shut down eight clinical trials for PTSD involving an experimental drug designed to synthetically imitate the effects of cannabis. A similar drug was found to be responsible for the death of one French study participant in January.
After showing that people suffering from post-traumatic stress disorder have an imbalance in their endocannabinoid system, Alexander Neumeister, then the director of the molecular imaging program in the Departments of Psychiatry and Radiology at NYU School of Medicine, got the go-ahead from NYU, and the funding from pharmaceutical giant Pfizer, to run a clinical trial on a poorly understood class of drugs known as FAAH inhibitors.
FAAH inhibitors interact with the body’s natural endocannabinoid by preventing it from degrading anandamide, a neurotransmitter generated in the body to activate cannabinoid receptors. Researchers from many different fields are attempting to use these drugs to create a cannabis-like response in the body by activating cannabinoid receptors, but without the psychoactive effect of smoking marijuana.
In January six study participants in France also taking an FAAH inhibitor were hospitalized due to severe neurological injuries, which were fatal in one patient. Directly following that incident, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, suspended their phase 2 clinical trial involving the same class of drugs out of fear it could harm patients. Despite mounting evidence that FAAH inhibitors are unsafe and unnecessary, doctors at NYU obtained approval to give these drugs to people suffering from PTSD.
Thanks to an investigation by the New York Times, details of this potentially tragic drug trial have come to light. After confirming reported concerns over poor compliance with research protocol in Dr. Neumeister’s lab, the director of NYU’s psychiatry department, Dr. Charles Marmar suspended all activity in the lab and forced Neumeister to take a leave of absence; he later resigned.
Dr. Neumeister’s lawyer admitted there may have been protocol violations, “but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were,” and noted the lack of evidence that any of the study participants were harmed.
What kind of protocol violations may have occurred? While the study called for 50 participants, they only recruited 14, many of which had already been part of other studies by Dr. Neumeister. At least one had participated in another study only 16 days prior, when the research called for a window of 30 days.
Study participants with mental disorders such as PTSD are extremely sensitive to adverse reactions to new, experimental drugs and need to be closely monitored throughout the process. This latest study failed to assess three patients 24 hours after taking the drug for the first time. An investigation by the FDA found that Dr. Neumeister falsified documents by signing a colleagues name in several instances.
Due to poor organization at the beginning of the trial, one participant was instructed to stop and start her psychiatry medications abruptly several times, exposing her to severe withdrawals and side effects.
It seems both Dr. Neumeister and Pfizer wanted this drug to gain approval one way or another. As a specialist in brain imaging, Neumeister wanted to use this technology to tailor specific medications for different neuropsychiatric conditions such as PTSD. Though the research and the concept seemed promising, poor understanding of the body’s endocannabinoid system was their downfall. Hopefully researchers begin to understand that dangerous FAAH inhibitors are not the answer for people seeking medical marijuana; medical marijuana is the answer for people seeking medical marijuana.