Agents of the Food and Drug Administration know better than anyone else just how bad scientiic misbehavior can get.
Reading the FDA’s inspection files… It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing.
Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.
That misconduct happens isn’t shocking. What is: When the FDA inds scientiic fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientiic 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.
[A]s part of my investigative reporting class at New York University, my students and I set out to find out just how bad the problem was…
We didn’t have to search very hard to ind FDA burying evidence of research misconduct.
When there are problems, the FDA generates a lot of paperwork… and in the worst cases… Warning Letters.
[M]ost of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.
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.
[T]he FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware.
Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and eective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites.
[T]he FDA found falsified data.
[T]here was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud…
[I]n the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. 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.
By itself, this might seem like a miscommunication or an oversight, but the FDA has a history of not notifying the public about the misconduct it finds.
About a decade ago, the agency got into trouble over a newly approved antibiotic, Ketek. Inspectors had found extensive problems (including fraud) aecting key clinical trials of the drug. Yet the agency did its best to hide the problems from even its most trusted advisers.
As David Ross, the FDA oficial in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.”
Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or eectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA- approved drug labels.
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 most common excuse the agency gives is that exposing the details about scientific wrongdoing— naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “conidential commercial information” that would hurt drug companies if revealed.
Another excuse I’ve heard from the FDA is that it doesn’t want to confuse the public by telling us about problems…
The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials.
Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientiic trials turn out to be less than reputable. It does so not only by passive silence, but by active deception.
And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change.
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.