In at least 57 clinical trials conducted from 1998 to 2013, the US Food and Drug Administration found evidence of falsification, problems with reporting side-effects, inadequate record-keeping, and more. But only three of the resulting 78 publications monitored in today's report mentioned the misconduct uncovered during inspections. And no corrections, retractions, or other comments were added after publication. The author of today's report blames "regulatory capture" for the lapse, or a type of corruption where a public agency protects the interests of the groups it's meant to regulate rather than the interests of the public at large.
the misconduct isn't surprising; the fda's silence is Protocol violations — where researchers didn't follow their stated methodology — were most common, occurring in three-quarters of the trials, according to today's report in JAMA Internal Medicine. And many patients weren't properly informed before they consented to be studied, or the trials they were in lacked oversight in more than half of the research. Two-thirds of the trials had inadequate or wrong record-keeping. Also common: falsification or the submission of false information, which occurred in 39 percent of trials. In a quarter of the trials, there were problems with reporting adverse events — that is, serious side health concerns that may arise in either the test or control groups.
The misconduct itself isn't so surprising, writes study author Charles Seife, who is also a journalism professor at New York University. Here's what he says is surprising, though:
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.
In one case, falsified data led to a patient's deathIn at least one case, falsified data led to a patient's death, in a trial that compared chemotherapy regimens. In another trial, describing a stem cell treatment in 26 patients, all patients were described as having improved, even though one later had to have a foot amputated two weeks after being treated. And in yet another case, the FDA considered the entire clinical trial unreliable — which wasn't noted in the publication.
What that means is that patients and doctors are left uninformed by the agency that's meant to protect them. Both Seife's article and its accompanying editorial suggest the FDA's reports of inspection should be attached to the Clinicaltrials.gov database, so anyone can find them.
The FDA told Reuters that it's "committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decisions, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products."
Seife despairs at the FDA, in his piece for Slate, which is worth reading in full:
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 scientific 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. We can no longer hope that the situation will get better without firm action from the legislature.