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Drug Safety Monitoring for the 21st Century

http://blogs.wsj.com/health/2008/04/15/drug-safety-monitoring-for-the-21st-century/#comment-160365
Posted by Jacob Goldstein

For all the health data sitting on computers in this country, our drug safety surveillance is remarkably primitive, relying on clinical trials (which capture a tiny percentage of those taking prescription drugs) and sporadic reports from doctors and drugmakers.

A deal announced last month could change that.
The FDA will contract with WellPoint, the country’s biggest private health insurer, to monitor and mine the company’s massive patient database for signs of drug safety problems, the WSJ reports. A similar deal with UnitedHealth is in the works.

“Before, we had to do those studies in a hand-built way: We needed to find everyone who took a given drug and trace back whether they had a heart attack or something,” Jerry Avorn, a Harvard doc whose academic team has been advising WellPoint on its drug-safety system, told the WSJ. “It’s much more efficient to have a system whirring away that is asking these questions.”

The poster child for why we need this sort of system is Vioxx. The Merck painkiller was taken by 20 million people over the course of five years, before clinical trial data revealed that the drug raised the risk of heart attacks.

Using its new safety monitoring system, WellPoint went back and crunched its patient data for Vioxx. The company concluded that it could have picked up safety problems tied to the drug within four months after its 1999 debut, the WSJ says.

Indeed, Kaiser Permanente was using its patient database to monitor Vioxx at the time, and based on its own findings the group curtailed the use of the drug a year before its withdrawal, and removed Vioxx from its formulary altogether a month before the Merck recall was announced.