The U.S. Food and Drug Administration is supposed to protect the American public. It’s supposed to stand between the public and purveyors of cures, medical devices, techniques, procedures and drugs, making sure that these techniques have been properly vetted and are safe before they’re used on a defenseless American public.
I’m upset to have to say that while I certainly expect the FDA to be in bed with big pharmaceutical companies and big medical during republican administrations and times when republicans control Congress, the fact of the matter is that the FDA hasn’t exactly been an ally of the consumer during this most recent eight year democratic presidential administration, either.
This tells me all I need to know about how rampant and endemic the fraudulent and far-too-close relationship is between the FDA on the one hand, and big pharmaceuticals on the other.
The FDA treats this almost sacred duty with a great degree of irreverence, carelessness and secrecy, according to a new report for Slate. According to this report, the FDA routinely hides important safety data from the public, works to make that information inaccessible by request, and allows conclusions about the safety and efficacy of drugs that are known to be discredited or doubted to stand.
One recent example of such misconduct on the behalf of researchers, which the FDA chose to obfuscate from public knowledge, involved a series of trials known as the RECORD Studies. Specifically, Record Four was found to be entirely unreliable and its findings discredited. Yet as the research reported in the article on Slate indicates, the conclusions drawn from that study are still allowed to stand without any retraction, correction or notation that its underlying researcher has been discredited.
The drug under inquiry in the Record Four Study is called Xarelto. The drug is angling to be a replacement to the drug Warfarin in the pharmaceutical market place. Xarelto has been hotly contested as reports implicate the drug in cases were side effects may have been responsible for catastrophic injuries to patients, even death.
Continuing research indicates that the weakness of the research behind Xarelto makes it no outlier. Regularly, drugs have their underlying studies discredited or doubted, and yet, the FDA hesitates to inform the public; even going so far as to resist Congressional questioning.
This not how this is supposed to work. The FDA is supposed to protect us. People can be smart and well educated, but know nothing about the complex biochemical medicine that underlies pharmaceutical research. No one can afford to do their job well and raise their family and be an expert in which drugs are safe and which drugs aren’t, even doctors. If the FDA doesn’t do its job, who will?
Hold not only this administration, but the next administration, whether democratic or republican, responsible for making the FDA do its job, damn the consequences. Big business – specifically big pharmaceutical big business – isn’t more important than the safety of one person the FDA is supposed to be protecting.