#FDA inspections: Fraud, fabrication, and scientific misconduct are hidden from the public and doctors.
It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware . The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.
Why does the FDA stay silent about fraud and misconduct in scientific studies of pharmaceuticals? Why would the agency allow claims that have been undermined by fraud to appear on drug labels? And why on earth would it throw up roadblocks to prevent the public, the medical community, its advisory panels, and even Congress from finding out about the extent of medical misconduct? The answers the FDA gives are fascinating—(...).
(...) But even the most paternalistic philosophy of public health can’t explain why the FDA would allow drug companies to put data on its labels that the agency knows are worthless, or to fail to flag bioequivalence problems in a publication that is specifically designed for the purpose of flagging those very problems.
It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.