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03.21.2006 (previous | next)
"We're From the Government, and We're Here to Help You!"

Those who believe that IP should be eliminated and development of such things as life-saving pharmaceuticals left to the government need to read a letter in today's WSJ. The current regulatory system is quite obtuse enough, thank you:

My wife had terminal non-smoker's lung cancer. On May 25, 2005, her oncologist, having treated her with a variety of chemotherapy drugs that all failed . . . suggested one last ditch effort -- Iressa. A miracle followed: Her tumors shrank; her chronic, debilitating, morphine-treated pain ceased without trace. This happy condition lasted for seven months, when Iressa finally failed her.

But on Sept. 15, 2005, the FDA took Iressa off the market.

When I recall that the FDA removed a drug that worked, that the drug had demonstrably helped 10% of lung cancer patients, that the decision for its use no longer remains one between oncologist and patient, and that some 15,000 annual lung cancer victims can no longer get the merciful help my wife did, my heart and mind cry out that such FDA prohibitions are outrageous and unthinkably cruel.

As C.S. Lewis once observed, bad acts are usually performed by people "with clean fingernails working in well lit offices."

And:

You wonder in disbelief as to what kind of misanthropic contrivance is controlling things at the FDA. You are told that it has to be this way so as not to violate the purity of statistical analysis.

But if science can put a man on the moon, it surely can arrange for statistical analysis, which identifies people as numbers, to work alongside clinical evaluation, which identifies people as mothers, sons, husbands, daughters.

Ronald L. Trowbridge, Ph.D.
Adjunct Scholar
Abigail Alliance for Better Access to Developmental Drugs
Arlington, Va.

posted by James DeLong @ 2:17 PM | Big Tent

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