An interesting sidebar to an FDA panel's shocking decision late last week to narrowly reinstate Vioxx was a story in last weekend's Chicago Tribune about the terrible treatment of Dr. Charles Bennett, a Northwestern University researcher, often a harsh critic of the agency's practices regarding drug safety. Or, in most cases, a lack of it.
After a scathing report that gave them a failing grade, the FDA revoked the researcher's special access to its adverse drug reaction database late last fall. The ban -- a more vindictive, punitive act on the surface than anything else -- just adds more gasoline to a firestorm of criticism that underscores the FDA's fatally flawed way of handling drug safety.
And that's a big shame. Bennett is one of two physicians who leads a surveillance program, in collaboration with reseachers across the United States and Canada, that monitors reactions to drugs that cause organ failure or death.
What got Bennett in trouble: A report published last year in Stroke (see link to the free text article below) that blasted the FDA's handling of Plavix. Nine months later, the agency cut off Bennett and his group, allegedly because "thousands of requests make it impractical and unfair to afford you and your groups special status." You be the judge, folks.
Dr. Bennett feels much the same way I do about the sad state of affairs involving drug safety in this country. "The system is broken in many ways, and safety is on the bottom of their lists."
Chicago Tribune February 20, 2005
Stroke February 2004;35:533 (free full text article)