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Biotech / Medical : 2001* The One for Boom or Doom! -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (138)	2/23/2001 6:28:13 PM
From: opalapril	Respond to of 146

Tough problem. If the drug works but one arm doesn't get it, Discovery Labs is denying needed medicine to poor infants. If it turns out to have dangerous side effects, then they're killing Hispanic children. (Remember Thalidomide in West Germany? The babies-for-body-parts rumors that periodically sweep Guatemala?) As you know, in Mexico and most Latin American countries a lot of compounds for which we require a Rx are sold OTC -- and plenty more get peddled that have not been approved here. Perhaps the different regulatory environs will make a difference to the FDA, but I doubt it. For that matter, I'm not sure I approve giving a totally untested and unproved drug to both arms of a trial even on compassionate grounds. On the other hand, I would favor the equivalent of DSMB reviews early and often, with perhaps more generous standards for stopping the trial in the event the drug proves safe even if only marginally effective. Ah, but an embarrassing mental image forms in one's mind of somber, self-important doctors, scientists, diplomats, lawyers, and regulatory officials endlessly negotiating over whether to give untested drugs to poor Latin American children or let them die. For some reason this recalls to my mind a once-famous Benchley reminiscence from his undergraduate days. He discovered the night before finals began that the previous Fall he had registered for a course titled something like, "Russian Foreign Policy Under the Czars." Benchley had been having too good a time that year to buy the text book or attend class, and so he approached the final exam with great trepidation. It turned out to be a single-question essay test: "Describe, discuss, and analyze the Russo-Turkish Fishing Rights Treat of 1774 from the viewpoint of the Russians or the Turks." Benchley was undaunted. He put pen to paper and began, "Knowing nothing about the minds of Russians or Turks, I will now describe, discuss, and analyze the Russo-Turkish Fishing Rights Treat of 1774 from the viewpoint of the fish." And then he did. He claimed he got an A in the course.