8 NYU drug studies gone awry: 6 things to know

New York University's medical school shut down eight studies associated with an experimental drug and dismissed the head researcher when it found a host of violations, according to The New York Times.

The New York Times put together the story in this investigative piece. Here are six key takeaways.

1. At issue is a series of studies designed to test the effectiveness of a drug similar to marijuana in treating post-traumatic stress disorder.

2. The lead investigator was Alexander Neumeister, MD, and the studies were sponsored by Pfizer, which had tested the same drug on osteoarthritic pain and reported it had no significant side effects, according to the report.

3. After people working with Dr. Neumeister reported concerns about the studies, the school put him on leave and suspended his activity. The Food and Drug Administration later stepped in to investigate, according to the report.

4. Investigators found the following main issues with the research:

  • The study had just 14 participants, though it called for 50. Many of those participants had participated in Dr. Neumeister's previous studies, and one had finished another drug study just 16 days before the start of Dr. Neumeister's.
  • One participant reported several false starts to the study. Because it required her to stop taking all her medications in advance, this meant she had to start and resume taking her medications multiple times, leading to negative side effects.
  • Several participants were not evaluated within a proper time frame after they received the drug.
  • Dr. Neumeister allegedly signed a fellow investigator's name on several reports, falsifying records.
  • In a letter to Dr. Neumesiter, provided to The New York Times, the FDA said the studies "jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site."

5. Dr. Neumeister's attorney has said the violations were not as egregious as they have been made out to be, especially considering Pfizer, the sponsor, did not halt the research, according to the report.

6. The university has discarded the results of the study and followed up with participants to check on their health, according to the report.

Read the full report here.

 

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