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Over the past two decades, as drug after drug has been recalled after winning FDA approval, it has been hard not to wonder if FDA regulators have been captured by the drug industry. FDA critics and industry monitors charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing. It relies on drug companies to perform all premarket testing on drugs for safety and efficacy. And it relies on industry "user fees" for 65% of its budget for postmarket monitoring of the drugs it approves, thanks to a 1992 law designed to speed treatments to patients.
Avandia Approval: FDA's Drug-Safety Protection in Doubt
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- Public Discussion (1)
I recently spent four days in the hospital with a pulmonary embolism caused by my birth control that I had only been on for one month. After doing some extensive research on the Internet, I found many other women, young and old, who had the same experience with the same drug. No history of blood clots, no other factors, just Levora. I was lucky, I went to the hospital when the pain became too much to bear and didn't require surgery (or a casket).
I remember hearing one time that FDA approval does not mean that a drug is safe, only that it "probably won't kill you." In a country where you can't legally drink raw milk in some states, it seems bizarre that chemicals with so many possible side effects (that include high rates of death) seem to be so under-regulated.
#1 - Fri Aug 13, 2010 12:05 PM EDTYou're in Easy Mode. If you prefer, you can use XHTML Mode instead. |
