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Could the Vioxx Debacle Have Been Averted?

Contrary, I suspect, to the opinion of Dr. David Graham, one of my heroes who was instrumental in blowing the whistle on the drug safety debacle in the United States, one former FDA official believes the safety problems associated with the deadly pain reliever Vioxx might have been averted had the agency been able to review some of health information compiled privately and publicly on about a third of all Americans.

The agency failed to take advantage of the pooled information from large databases, like those maintained by insurance companies and other federal agencies (that tracks the health of some 200 million Americans), says former FDA chief Dr. Mark McClellan who spoke at an Institute of Medicine symposium on drug safety earlier this week. Active checking on 100 million patients alone could've made the difference, McClellan says, in avoiding a disaster in a few months, rather than more than two years.

To do so, however, would require many more epidemiologists and computer programmers than the FDA currently employs, says Gerald Dal Pan, director of the agency's Office of Surveillance and Epidemiology. In fact, a government-administered database that could be up-and-running in two years might do the trick, says one Harvard expert in charge of researching such an effort.

Here's the really sobering number that illustrates how much of a problem drug safety currently is in America: For each of the nearly 450,000 adverse drug events reported to the FDA last year, nine problems weren't recorded and reported.

If you haven't watched Prescription For Disaster, a stinging indictment of the unholy relationships between government and big business that bring lethal drugs to market, I urge you to make some time to do so very soon.

USA Today March 13, 2007

Kaiser Network.org March 13, 2007

United Press International March 13, 2007