Thursday, January 13, 2005

Letter: How The FDA Can Prevent Another Vioxx

A letter from me on the value of EMR in postmarketing surveillance published by Business Week, January 10:

As a medical informatics specialist (combining medicine with postdoctoral-level information science and computing training), as well as a former Merck & Co. (MRK ) manager, I view the Vioxx controversy with concern ("How to prevent another Vioxx," News: Analysis & Commentary, Dec. 13). Post-marketing surveillance programs fail to produce any data at all if the practitioner does not realize a problem may be due to a drug -- and this is likely the situation in a majority of cases.

The Food & Drug Administration's moves to improve the way it responds to risks from medical products, including better "data-mining," is a step in the right direction. My concern is that overconfidence in such initiatives may dilute the resolve needed for the fundamental and daunting task of implementing comprehensive electronic medical record (EMR) systems in clinical settings that could provide a solution to long-term postmarketing drug follow-up.

This may be one of the fist times this idea has appeared in the general business literature.

-- SS

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