How Should Drug Companies And Their Ad Agencies Respond To Safety Signals?
October 15th, 2007 Posted by: Dr. Cox
Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward
(Posted by Tom Lamb at DrugInjuryWatch.com)
The September 1, 2007 edition of Pharmaceutical Executive starts with the piece “From the Editor: What Do You Say?” which carried this intriguing sub-title: “The first safety signal is detected. Proof or disproof is literally years away. What has to happen so no patient will say, ‘You hid the risk’?”
For a lead-in on this piece, however, we draw from an October 15, 2007 post by Ed Feather “The Vioxx Moment” over at the ART + science: the PARTNERS+simons Blog:
Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine, uses the terms “the Vioxx moment” and “the Avandia moment” in his September 2007 “From the Editor” column. He describes these as “the moment when a safety signal has been detected on a drug, and no one yet knows for certain whether it is real or not – the moment when pharma companies and FDA alike set themselves up for a kick in the teeth.”