The U.S. Food and Drug Administration (FDA) exists to protect public health, but oftentimes the agency appears to be protecting drug companies rather than patients, according to an article published in Slate. Charles Seife, a journalist and professor at New York University, says that the agency repeatedly hides evidence of fraud in medical trials. “For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.” the article states.
Seife points out that in documents related to an FDA inspection, critical parts are redacted. The reader is left not knowing what drug was studied, the number of the study and how the data was affected by misconduct. Seife and his students analyzed documents related to 600 clinical trials where there was a failed FDA inspection. He reports that they were only able to find the study, the drug and the identity of the pharmaceutical company in about 100 cases.
This type of omission affects both consumers as well as researchers and physicians. According to the Slate article, the FDA is aware of dozens of studies with questionable data but has not taken any action. This was the case with the RECORD 4 study, which was one of four large clinical trials used as evidence for the safety and efficacy of the anti-clotting drug Xarelto (rivaroxaban). RECORD 4 involved thousands of patients and clinical sites in more than a dozen countries around the world. The FDA inspected or had access to external audits of 16 sites, the article says. Seife calls the trial “a fiasco” and says the agency found falsified data at Dr. Craig Loucks’ site in Colorado and “systematic discarding of medical records” at Dr. Ricardo Esquivel’s site in Mexico. The agency found misconduct, fraud, suspicious behavior and other practices that were so questionable the data had to be discarded in half of the sites. “The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be ‘unreliable.’” Seife says.
Xarelto has become the subject of safety concerns and lawsuits alleging that the drug caused uncontrollable bleeding. Plaintiffs allege that the drug was marketed as being superior to warfarin, an older drug that requires blood monitoring. Xarelto has raised safety concerns because unlike warfarin, there is no antidote to reverse bleeding if it occurs.
The article goes on to say that despite knowing this, data from RECORD 4 continues to remain in The Lancet without any indication about falsification or wrongdoings. “This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.” says Seife. According to this article, this type of behavior is not simply miscommunication or oversight. Apparently, the agency even resisted attempts by Congress to obtain more information.
“Every excuse under the sun has been used to create roadblocks,” said Sen. Charles Grassley in relation to problems with clinical trials of the antibiotic Ketek. “even in the face of congressional subpoenas requesting information and access to FDA employees.”