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Drug Safety Under the Microscope

Posted Oct 28 2008 9:56pm

The recent news around a study last month linking GlaxoSmithKline’s Avandia to increased heart risks has fueled criticism of the FDA’s drug safety process and of drug makers.

In the media circus, the headline has been the startling revelation that Avandia increased the risk of heart attacks by a whopping 43%. Yet all media stories conveniently ignored that the overall risk of heart attacks is still surprisingly low—just 0.6%...for BOTH Avandia as well as control groups. The values: 86/14,371 for Avandia and 72/11,634 for control.

Congressional watchdogs are blaming Congress. Congress has responded that last month’s FDA reform package will fix all ills (real or imagined). Industry watchdogs are blaming the FDA, which has conveyed July 20 panel to review Avandia data as well as data for TAP Pharmaceutical’s Actos. And everybody else is blaming manufacturers, which is par for the course.

It is alarming, although not altogether surprising, how bad journalism has become in the healthcare space. Earlier this year, we had sensational news stories about the dangers of Zelnorm and Novartis’ decision to pull the drug. The result has been devastating for patients who have been caught between the realities of their disease and the politicized, sensational media coverage that has ensued.

All drugs have risks—be it Tylenol or Avandia or Zelnorm or Vioxx. We cannot have an effective medical system without any risks at all.
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