As stated in their mission statement, the US Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety and efficacy of drugs, biological products, medical devices, food, and more.1FDA Uncovers Fraud, Incompetence, and Misconduct in Clinical Trials… Says Nothing
It’s a tall order, no doubt, but the FDA makes many glaring omissions or, some might say, blatant oversights that put the public’s health at risk. Yet, the public is quite understanding and tolerant of the FDA’s mistakes and industry-friendly positions.
For instance, even as they continue to ignore the risks of antibiotics in animal feed, deceive you about mercury amalgams, and allow Americans to consume questionable foods that are banned in other countries…
There is no major public uproar or demand for a (much-needed) overall of the agency. But it is hard to defend an agency that continually acts against the best interests of the public they’re entrusted to defend.
Now, due to the efforts of a professor and his students at the Arthur L. Carter Institute of Journalism at New York University, we have yet another example of the FDA failing to warn Americans, in this case about grave concerns due to falsifications in published data.
The FDA reviews several hundred clinical trial locations that conduct research on human participants each year in order to be sure they’re engaging in good clinical practice. But what happens when they find evidence of questionable procedures or practices?Read more..
In the most serious of cases, the FDA can classify it as “official action indicated,” or OAI. This is reserved for “severe” forms of clinical trial violations, including "objectionable conditions or practices" that warrant compulsory regulatory action, as opposed to "voluntary action indicated" for lesser violations.”2
Now, if a trial had been deemed OAI by the FDA, you might assume that you’d see evidence of that when reading the results of studies based on said data. But that would be a liberal assumption. Researchers conducted a review of FDA inspection reports between 1998 and 2013.
They found 60 clinical trials that had been classified as OAI, and these trials had been used for data in 78 published articles. Out of those 78 studies, only three included mentions of the violations found by the FDA!
And we’re not talking about small, innocent mistakes. The violations included fraud, incompetence, and misconduct. This means that anyone browsing a medical journal might be making decisions based on fraudulent published studies.
Studies that the FDA knows contain grave errors… but chose not to say anything about. While you might not personally read this misleading data, your doctor might. As the study’s lead researcher, Charles Seife, noted:3
“Your physician makes decisions based upon what he knows from the peer-reviewed literature… If that literature is tainted in some way without the physician knowing, then the physician is making treatment decisions based upon bad data."