Study reveals FDA reporting issues

Alanna Bayarin and Marita Vlachou

A study released in the Journal of the American Medical Association exposed the inconsistent reports by the Food and Drug Administration on the subject of how clinical sites research human subjects. The report was published by NYU professor Charles Seife, who worked with NYU graduate journalism students to uncover scientific fraud.

Lydia Chain, a journalism graduate student who was hired as Seife’s research assistant, was inspired by his interest in identifying misconduct.

“I was interested in the job because he has quite the nose for interesting fraud and I was curious to see what he would find,” Chain said.

Seife said he and his students read heavily redacted FDA documents detailing clinical research sites. They tried to see which studies the documents were describing, and then checked to see if the problems the FDA found were reflected in peer review literature. 

“I was scouring these papers, and of the 78 that I read, only three mentioned there was a problem, and each only used one sentence,” Anderson said. “It seemed impossible that so many papers wouldn’t acknowledge that data was flawed.”

Seife said the FDA omitted important parts of their studies to make it appear as if there were fewer mistakes in research.

“For the published studies we were able to identify, the vast majority had no mention of the problems, even when they involved fabrication or fraud,” Seife said.

Seife said he has been invested in identifying misconduct in the scientific process for a long time.

“I began the investigation because I have a longstanding interest in how we deceive ourselves and how human frailty affects the scientific process, and I realized that I could structure a class around looking at warning letters,” Seife said.

NYU alumnus Joshua Krisch, who was one of the students who worked with Seife on the investigation, wrote an article published on about the study. He said the FDA purposefully left out mistakes in medical reports.

“The problem wasn’t finding fraud — it was deciding which heinous act of straight-up medical chicanery to use,” Krisch said in the article. “Blatant dishonesty had tainted thousands of medical studies. I found clinical trials with fake patients, doctors who never bothered obtaining consent, forgeries and cover-ups galore. The FDA database was a veritable ‘who’s who’ of dirty researchers.”

A version of this article appeared in the Thursday, Feb. 12 print edition. Email Alanna and Marita at [email protected].