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The Price of Too Much Caution
Dr. Scott Gottlieb, New York Sun, 12-22-04

This is another winner from Dr. Gottlieb, who reminds us that the current furor over pharmaceutical safety has, ironically, grown out of the real safety gains made by industry in recent decades. Comparing the pharmaceutical industry to the airline sector, Gottlieb notes that both of them are very heavily regulated and have excellent safety records; nonetheless, the better and more successful they are at safety, the worse every individual failure appears in the public eye.

Gottlieb writes that safety is always a trade-off between risks and benefits, and that “today we have the safest [drug] system in the world, but few glaring gaps to easily improve on. When it comes to making new drugs safer, most of the obvious solutions are already accounted for and we have reached the flat part of the curve that measures incremental safety against the additional cost. We can make our drug development system a little safer, but only at a very big cost.”

Project FDA.
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