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FDA Requiring Suicide Risk Assessment for Clinical Trials

Feb 9, 08 According to a recent New York Times article, the FDA is now requiring drug makers to assess suicide risk during clinical trials.

Critics say this requirement is long overdue, while others say determining depressive versus suicidal effects is too difficult to establish.

Do you agree or disagree with the FDA's requirement? Comments?

David Baxter PhD

Late Founder
I think if the FDA wants this to happen they are going to have to think carefully about setting up some very specific guidelines spelling how they expect people to do this.

The recent debacles with respect to SSRIs were, from a scientific viewpoint, embarrassing to the health regulators (FDA, Health Canada, and the UK equivalent), in my opinion. It was a rank overreaction to purely anectdotal and correlational "evidence" with no foundation in anything even approaching real science. If that's the kind of "evidence" the FDA wants from drug manufacturers, I'd love to see it spelled out so it's there for public and more importantly scientific scrutiny.
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