The Food and Drug Administration is tasked with ensuring the safety and effectiveness of the drugs and products that the public is sold for its health and well being. It’s a task of critical importance and one that the FDA seems to be treating with inappropriate irreverence and secrecy, according to a new report for Slate. According to the 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 such example of 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 4 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 is still allowed to stand without any retraction, correction or notation that its underlying research has been discredited.
The drug under inquiry in the RECORD 4 study is named Xarelto. The drug is angling to be a replacement to the drug warfarin in the pharmaceutical marketplace. Xarelto has been hotly contested as reports indicate the drug in cases where side effects may have been responsible for catastrophic injuries to patients, even death.
Ned McWilliams, an attorney with the Levin, Papantonio law firm, noted that, “These revelations further undermine the data that purportedly establish the safety and efficacy of Xarelto.”
Continuing research indicates that the weaknesses 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.
Why would the FDA work to keep such information away from the public? Why would it go out of its way to avoid harming the companies that make these products rather than preventing harm to the patients that use them?
The simple answer, according to Charles Seife, author of the Slate report, is rather simple. The regulating agency has developed relationships with the industry it is supposed to oversee that are too comfortable to be shaken.
From Slate:
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 out of 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.
