Thursday, December 27, 2012
Jack Klugman’s secret, lifesaving legacy in the Washington Post details how Klugman used his celebrity as Dr. Quincy to pressure Congress into passing the Orphan Drugs Act which, by lowering the regulatory burden and lowering the cost of clinical trials led to many drugs coming to market including AZT. The story is cast with the Democrats as good guys and a lone Republican Senator, Orrin Hatch, as the bad guy. But the question the article never asks is why, if it is such a good idea to lower regulatory burdens in the case of small market drugs, isn't it a good idea for all drugs? The FDA is focused solely on the dangers of new drugs and never tallies the cost in drugs that are not developed in the first place because of the regulatory burdens they the agency, empowered by its mainly Democratic allies and supporters in Congress, create. How much progress is snuffed out by the FDA's insistence on proof of effectiveness instead of simply safety and the blocking of the use of patient data from real world use by the privacy rules imposed on the use of patient data? If it was such a good idea to get the FDA out of the way in the case of rare diseases why not try it for more common and more deadly diseases? There would be a real lifesaving legacy.