FDA Hides Fraud and Scientific MisconductFeb 11, 2015
An investigative report by a New York University journalism professor and his students reveals that for more than a decade, the Food and Drug Administration (FDA) has been burying the details of scientific fraud and misconduct.
The report – published in JAMA Internal Medicine – charges that the FDA has hidden evidence of fraud from the medical community, the public, and even from scientific advisers deciding whether a new drug should be allowed on the market, Slate.com reports.
As part of the new drug approval process, FDA inspectors visit clinical sites to make sure work is being done according to regulations. When there are problems, the FDA generates what are called form 483s, Establishment Inspection Reports. In the worst cases, the organization receives a warning letter. Seife’s team found that key portions of some reports are redacted: the drug being studied, the name of the study, and how the misconduct affected the quality of the data have all been blacked out. The redactions make it nearly impossible to figure out which study is tainted, Seife writes in Slate. Seife’s team examined FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only about 100 cases were they able to determine which study, which drug and which pharmaceutical company were involved. For the other 500, the FDA shielded the drug maker (and the study sponsor) from public exposure.
One such case was the RECORD-4 study, one of four large clinical trials used as evidence that a new blood-thinning drug, rivaroxaban (brand name Xarelto), was safe and effective. At sites in the trial, FDA inspectors found such problems as falsified data and systematic discarding of medical records, which made it impossible to tell whether the study drug was given to the patients. At half of the sites—eight out of 16— inspectors found misconduct, fraud, or other objectionable practices. The FDA declared the entire study "unreliable," according to Slate.com. Yet, Seife says, the results from RECORD 4 appear in The Lancet "without any hint in the literature about falsification, misconduct, or chaos behind the scenes." Physicians are basing "life-and-death medical decisions" on a study that the FDA knows is not credible. "The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply," Seife writes in Slate.