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by David Egilman, MD, MPH
I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays’ (R-CT) comments. Christopher Shays is the last remaining Republican congressman from New England. Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.
He repeatedly stated that he “had no dog in this hunt” concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA’s actions are appropriate. It’s one thing to have no opinion; it is in another to imply that there is no reason to have opinion.
By David Michaels
Dr. David Healy is the probably the single person most responsible for identifying the link between anti-depression drugs like Zoloft and suicide risk. His work led to the FDA to require the addition of a “black box” to the label of selective serotonin reuptake inhibitors (SSRIs), warning of the increased risk for “suicidality.” A few years before the FDA instituted this policy, Dr. Healy was asked to testify about the effects of Zoloft in a lawsuit filed by the parents of Matthew Miller, a teenager who hanged himself soon after starting taking the drug for depression. Healy never took the stand. As Barry Yeoman’s important article Science in the Dock in this week’s issue of The Nation explains, the judge hearing the case refused to allow Dr. Healy to testify, ruling that his belief in the SSRI-suicide link is a “distinctly minority view.”
Dr. Healy was “Dauberted”. The same thing has happened to other respected scientists. Yeoman describes in alarming detail how the Supreme Court’s 1993 ruling in Daubert v. Merrell-Dow has had troubling consequences.