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Avandia, the Drug Safety Debate and How to Get a Nobel Prize
Posted by Ogan Gurel MD MPhil at 22 July 2007, 5:17 PM and is filed under Safety,Diabetes,Practice of Medicine,Health policy,FDA Reform,Pharmaceuticals,Gl axoSmithKline,Avandia


Drug (and device) safety has been one of this blog’s recurring themes. Last year’s article “Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial” highlighted why safety is a growing issue and, very pointedly, forecast that this controversy would continue. Indeed this prediction has been correct. Throughout the medicine’s history, safety has always been important. Hippocrates’ most famous dictum (not in his oath but rather an attributed aphorism) is that of primum non nocere - “First, Do No Harm” which has been a guiding principle for physicians for several millennia.

For anyone reading the headlines, safety has recently gained in importance and the reasons for this trend can be summarized as follows:
Greater efficacy of medicine. As treatments become more effective, the “blemishes” become more evident. In technical terms, the risk-benefit profile gets shifted towards a higher awareness of risk (e.g. safety).
Baby boomer (or convenience) culture. This is a major population force as this group characteristically holds high expectations and little tolerance for failure.
Chronic diseases. When people take drugs or use devices for extended periods of time, what might have been a mere side effect can metamorphose into a significant safety risk.
Preventative medicine. Likewise in using drugs or devices for preventative purposes, safety becomes that much more important. It’s hard to justify a safety risk in the context of a condition with no symptoms.
Quality-of-Life Treatments Drugs and devices that provide quality-of-life benefits rather than being explicitly life-saving are necessarily held to a much higher standard of safety.