Aprotinin And The Fda Approval Process

Can you imagine what would happen if three jumbo jets crashed in one month? A thousand people dead. Uproar at the FAA. Planes grounded. Immediate comprehensive inspections of all aircraft. Congressional hearings and investigations. Everything possible would be done to immediately assure public safety. But what if, within one month's time, a thousand people were seriously injured or died from a known side-effect of a prescription drug that, perhaps, should have never been on the market? In a recent case, nothing happened. And, depending on how the US Supreme Court rules in a case before it, individuals affected by such FDA-approved prescription drugs would have no right to sue, no right to hold a company accountable for a dangerous drug.
Consider the twisted saga of the drug Trasylol (generic name Aprotinin), used to prevent bleeding in heart-bypass surgery. Most people never heard of it until stories appeared on major TV networks recently.

Despite knowledge as early as 1993 from Bayer studies that Trasylol was toxic to the kidneys, the Food and Drug Administration approved the drug, and it went to market. What's worse, although the drug's initial use was for high-bleed bypass operations, the FDA in 1998 approved it for any type of heart bypass operation, triggering a rapid growth in its use, with an estimated 350,000 patients, often unknowingly, receiving it in 2005.

Yet the drug company and the FDA did little to investigate the problems with the drug. Not until Dennis Mangano, an independent researcher, published an article in the New England Journal of Medicine in 2006 demonstrating the higher risk of death from Trasylol than from cheaper generic drugs did the FDA issue a health advisory. Mangano estimates that about 1,000 patients have died each month as result of Trasylol remaining on the market. One thousand a month, like three jumbo jets falling out of the sky every month.

For more see; http://www.philly.com/inquirer/opinion/16670451.html