FDA conceals serious research misconduct–fraud, deception, even deaths
FDA documents obtained under the Freedom of Information Act, revealed that the FDA has been concealing from the medical community and the public serious research misconduct; including fraud, deception, avoidable risks for human subjects — even deaths — that occurred in clinical trials. The FDA documents were obtained by Charles Seife, a journalism professor at New York University, and author of several books about deception.
Key portions in most of the FDA documents were heavily redacted. The missing information includes: the name of the drug studied, the name of the study, and specifically how the misconduct affected the quality / reliability of the data. This made it all but impossible to sort out which study was tainted. Seife and his students examined 600 clinical trials; they were able to identify the drug and pharmaceutical company involved in about 100 cases.
In 2015, Seife published two extremely important articles about FDA concealment of vital medical — one in Slate another in JAMA (the Journal of the American Medical Association). We post excerpts from the Slate article which includes links to the FDA inspectors’ documents; followed by the abstract of the JAMA article.