Tuesday, April 1, 2008

Drug Timing

Is it a coincidence that 14 of the 21 drug withdrawals or black-box warnings for drugs approved since 1993 were approved within two months before the deadline for new drug applications? To look at it another way, the 97 drugs approved near the FDA's deadline had a 14% rate of severe safety problems compared with a 3% rate for 216 other drugs.

Could it be the FDA's effort to "fast track" drug approvals is leading to cutting corners? Today the agency promises to decide on 90% of drug applications within 10 months. In 1991 it took them 33 months to decide on a new drug. Drugs like Vioxx, Baycol and Rezulin were all approved within two months of deadline. There is no law forcing this schedule, just politics and pressure from the drug industry in a rush to make money. While some people can't wait for the newest drug, others pay a deadly price for such haste.

Compare this system to the world of complementary and alternative therapies which have been around for decades, hundreds ... sometimes even thousands of years. Regardless of what mainstream medicine says, if these treatments weren't effective they would not have survived. Which would you rather have?

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