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Peter Wetherall
Peter Wetherall
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Sentinel Initiative–The "Underfunded" FDA will Monitor Drug and Device Safety?

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The Sentinel Initiative was announced by federal health officials recently.   The Sentinel Initiative is designed to enable the Food and Drug Administration and others to analyze databases of health records compiled by the government, insurers and HMO’s to try to identify side effects from prescription drugs and medical devices.  The current system (MedWatch) relies heavily on voluntary reporting by healthcare professionals and consumers (http://www.fda.gov/medwatch/) and self reporting by big pharma.  But, it is plagued by underreporting, reporting biases, and failure to recognize side effects as possible signals which would alert the FDA and medical community to possible dangers.    
The Sentinel Initiative will include the development of a system called the “Sentinel System” that will enable the FDA to collect data about drugs and devices and to query that database to “mine” for side effects.    While the current reporting system is lacking, it remains to be seen if the Sentinel Initiative will work in the current environment.  The FDA is underfunded and understaffed.  The Washington Post recently reported a “brain drain” at the FDA as scientists and staffers leave the FDA.  So, it remains to be seen if the Sentinel system will work.  After all what is the point of having a Sentinel system, if there is no one left to operate it?