The Food And Drug Administration is in charge of inspecting the safety of, as the name implies, food and drugs, in the United States. It’s no secret that they routine find and internally expose bad science and dangerous pharmaceuticals, but it goes all too often unmentioned that they keep these findings secret.
A recent analysis of 78 clinical trials, comparing actual publishing with FDA findings, found that 57 had serious problems that had been identified by the FDA but never mentioned anywhere accessible to you or me. More than half of the research into these drugs, publicly “shown to be safe”, actually had hidden reasons to question this conclusion.
As the meta-analysis’ main author, Charles Seife, wrote in Slate:
That misconduct happens isn’t shocking. What is: 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.
This is actually an even bigger problem than it sounds. Not only are doctors and patients blocked from seeing how flawed clinical studies were, but scientists and congressmen are also prevented from seeing these details. Effectively, the FDA is aiding in hiding scientific corruption and further obscuring problems of publication bias.
What you eventually can get access to is heavily redacted. This means that any findings of the FDA investigations are effectively inaccessible to pretty much anyone demanding them. Seife’s study on 500 such documents was only able to identify what drug, and which company, in a little less than 100 of 500 studies. Here is an example of one, sent to a clinical investigator in 2012:
One example they were able to shine some light on was the RECORD 4 study into rivaroxaban. The FDA investigated several of multiple sites into rivaroxaban’s clinical effectiveness and safety. If you simply looked at this study, published in the prestigious Lancet, you wouldn’t be able to guess at the problems the FDA found during the trials that the study is based on.
What the FDA found out about the rivaroxaban trials was nothing short of multi-level corruption. At approximately 1/2 of the sites, they found that the data was not reliable, meaning misconduct, fraud, and generally sketchy behavior. At one of the study’s sites in Colorado, they found outright falsification of data. At the Mexico site, they were literally throwing away patient data that didn’t support their desired conclusions. The FDA’s conclusion that this study was “unreliable” can only be seconded when looking at the documents, yet this information is not visible to people looking for published research into this drug.
This isn’t an isolated example, but one of very many. In none of the instances is it publicly acknowledged that these studies were flawed, or that the data is unreliable. Even in the instances where it is possible to piece the investigations together and obtain uncensored information, this requires digging that most doctors and patients don’t have the time or experience to engage in. Even journalists are unlikely to know, as this article published in Reuters about mounting lawsuits over rivaroxaban generally portrays the research supporting the drug as reliable.
As I said, this is not just a problem for us, but for advisory panels for drug approval, and for representatives. This is also not a new problem. As David Ross, the FDA official in charge of reviewing a drug called Ketek’s safety, said: “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.” The FDA is keeping its mouth shut and downplaying or avoiding its own findings of corruption, and no laws or changes have been applied to fix this problem.
I think a valid question is why FDA data is censored or secret to begin with. Shouldn’t investigations into how safety data about drugs is being gathered be publicly available? Are we not, as citizens, paying for these investigations, and do doctors not have a right to know how valid the research they base their decisions on is? If you can see one good reason that this information shouldn’t be publicly available, then please share it with me, because I can think of none.