FDA, The Silent Sentinel

To paraphrase an old hymn, we’re prompted to pose this question to the U.S. Food and Drug Administration: “Will the silence be unbroken, by and by, by and by?” We’re talking about the silence the FDA has kept even when it has uncovered fraud or other forms of misdoings by companies running clinical trials on prescription drugs, a lack of disclosure that may have allowed dangerous drugs to receive approval and stay on the market even after the fraudulent research was uncovered.

According to its own website, the FDA “is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices.”

And yet, an investigation reported earlier this month in the Journal of the American Medical Association as well as several news publications revealed that the FDA has failed to protect the public health by hiding scientific misconduct that other scientists and the public need to know about.

“A pattern of burying […] misconduct”

It makes sense, doesn’t it, that in order to make sure a clinical trial is being properly conducted, there should be periodic inspections, on-site oversight by the FDA? NYU professor Charles Seife worked with NYU graduate journalism students to pore over FDA documents relating to about 600 clinical trials in which one of the researchers had actually failed an inspection. What Seife and his team found was summarized in Slate as follows:

When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. 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 FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

The Types of Misconduct

What kinds of fraud or misconduct have medical researchers been committing?

  • Submitting falsified X-ray assessments
  • Failing to report adverse side effects, including diarrhea and yeast infections
  • Substituting “good” scans for “bad” scans
  • Delegating to unauthorized personnel
  • Submitting false and altered documentation
  • Failing to report that one subject’s foot had to be amputated.

Flawed Medical Publications?

To make the problem more troubling, because the FDA has been lax about publicizing inspection details, the flawed research continues to live in medical literature. For example, Seife’s investigators found an instance in which 78 scientific publications resulted from one tainted study, one in which FDA inspectors identified significant problems, including fraud.

Faked Clinical Trials?

And there’s another angle to this story of faked clinical trials. The European Medicines Agency (EMA) –their FDA — has accused an Indian contract research organization (GVK Biosciences) of systematic fraud, fake testing spanning five years and involving nearly a dozen forgers. As a result, the EMA has recommended suspending sales of hundreds of generic drug formulations in Europe because their approval was based on questionable clinical trial data, including electrocardiogram reports which had been “manipulated.”

Why do we care what happens across the big pond? Because India’s pharmaceutical industry supplies 40 percent of the over-the-counter and generic prescription drugs consumed in the United States. For what it’s worth, overseas research companies are subject to inspections by the FDA, just like American ones are. GVK Bio’s chief executive officer has even issued a statement calling their FDA inspection “a clear testimony of the high standards of quality and processes followed at GVK BIO.” Right.

And, in case you’re wondering, the FDA has confirmed that GVK Biosciences conducted clinical studies used to support of approval of 40 drug products in the U.S. Which ones? They’re keeping silent about that.

Slate, “Are Your Medications Safe?”
JAMA Internal Medicine