A lead investigator of the New York University (N.Y.U.) has been dismissed and eight clinical studies on the effects of a mind-altering cannabis-like drug for patients with post-traumatic stress disorder (PTSD) were quietly brought to an end after the discovery of numerous protocol violations.
According to a report by The New York Times, federal investigators found that the researchers falsified records, kept inaccurate case histories, and failed to oversee study participants properly. Many of the volunteers struggled with severe mental issues and were abandoned to their fate after they were given the experimental drug.
“I think their intent was good, and they were considerate to me,” said one of those subjects, Diane Ruffcorn, 40, of Seattle, who said she was sexually abused as a child. “But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.”
Dodgy experiments jeopardize subject safety and welfare
Through documents, letters, and emails, as well as interviews with participants and researchers familiar with the project, The New York Times was able to compile the bigger picture.
In a letter to Dr. Alexander Neumeister, the studies’ lead investigator, the FDA wrote that these violations “jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site.”
For the trial, funded by Pfizer, Dr. Neumeister recruited 50 people with PTSD. Some of the participants took the drug over a seven-day period, while others took a placebo.
According to The Times, in at least 3 cases, federal inspectors reported that the team failed to examine the subjects within 24 hours after they had taken the experimental drug. Furthermore, they found that Dr. Neumeister had falsified documents in several instances, and the 30-day window between different experiments was not always respected.
Playing with lives
Ms. Ruffcorn, who writes a popular Facebook blog called A Little Bent said that she was randomly put off and back on her medication, causing severe issues.
“It was horrible,” she said. “I had flashbacks, returning nightmares, every symptom coming on full force, not to mention the withdrawal. After going off and back on four or five times, I told them, ‘I can’t do this anymore.'”
After the trial, she suffered odd symptoms, including a hyper, wired sensation that occurred without the usual memories of abuse. When she tried to figure out if these symptoms were due to the experimental drug, nobody could tell her whether she had taken the drug or the placebo.
Because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not give her any information. It took her months to find out that she was given a placebo.
Trials and development continue
After the reported concerns about the lab’s compliance with research standards, Dr. Neumeister was placed on forced leave, which resulted in the submission of his resignation. Nonetheless, given the concerns and dodgy nature of the experiments, Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., and Pfizer continued the trial.
Georges Lederman, a lawyer for Dr. Neumeister, admitted that there might have been protocol violations, “but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were.”
He further notes that these issues could easily have been remedied and said that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut down the trial. Pfizer, in their turn, said that N.Y.U. was responsible for conducting the trial and that they had previously tested the same drug for osteoarthritic pain, without any issues.
“The safety profile we observed does not preclude future development of our compound,” a Pfizer spokesman said by email.
Obviously, subject safety and welfare are not very high on Pfizer’s list. Instead of putting all our hopes in trials sponsored by drug companies, we should put our trust in projects conducted by independent scientists, such as the ones connected to the The Natural Science Journal and other non-profit organizations. This is a more honest and transparent approach to research as the studies are there to inform and protect rather than to generate revenue.
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