Briefs

WSJ Blogs, Jacob Goldstein, May 22, 2008

Our national system for detecting drug risks isn�t much of a system at all. Doctors and sometimes consumers haphazardly report potential problems, and the FDA sifts through those reports looking for signs of trouble.

It sounds like that�s about to change. Starting next month, FDA will begin actively mining the massive databases of more than 20 million patients who get their drugs through Medicare�s drug benefit. After that, the agency plans to start digging into data maintained by private insurers as well. For the worriers about Big Brother, you should know the agency won�t have access to details that identify individual patients.

The data mining should boost that odds that FDA can catch safety problems that would have gone unnoticed for years under the current system.

A bit of foreshadowing on this came last month, when the agency said it had contracted with the insurer WellPoint to monitor its big databases for drug safety problems. WellPoint said the system it�s putting in place could have detected safety problems associated with Merck�s withdrawn painkiller Vioxx within a few months. In part because no such system was in place, the drug remained on the market for several years.

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