FDA Oversight
No matter how you slice it Wednesday was not a great day for the FDA.
(CBS/60 Minutes)
Both the sale and use of Ketek has skyrocketed since its approval on April Fools Day 2004. Last year alone, 3.3 million prescriptions were written, all for a drug that, despite assurances from both the manufacturer and FDA of its safety, has some "serious data integrity problems," to quote Senator Charles Grassley's detailed report.
You have to hand it to Grassley and his investigative staff. At a time when Big Pharma seems in control much of Congress, or at least its legislative agenda, the straight-talking Senator from Iowa has stood up and called out companies like Sanofi-Aventis, maker of Ketek, over the integrity of its clinical trials, and the FDA for putting up with it.
"The Food and Drug Administration can't be in the business of misleading the public and hiding the truth," Grassley said, hard on the heels of the release of his report. "The integrity of the agency is at stake. The new commissioner [Dr. Andrew von Eschenbach] has promised to improve the way the FDA operates. If he lives up to his word, maybe something good will come of this."
I hope so. Although I'm not so sure given what Dr. David Ross told us. Dr. Ross headed the FDA's safety review of Ketek only to leave the agency after his superiors, including Dr. von Eschenbach, failed to act on his warnings. Worse, Ross said, von Eschenbach told him to pipe down, to keep his concerns inside the "locker room" or
he would "be traded."
Today America is a drug dependant nation. We take pills to wake us up, put us to sleep, soothe our stomach, increase our libido, ease our pain and anxiety, balance our moods, for just about every illness known to man or woman – and some that seem created by some magical medical mystery board (If you suffer from RLS or Restless Leg Syndrome…).
Are we really that addicted to what's in our purse, palm or medicine cabinet? What can be done to break Big Pharma's growing control of our minds and bodies?
I wish I knew.