>>My opinion is that what Abigail wants is inconsistent with drug regulation based on clinical trials as we know them. Why would anyone enroll in a clinical trial with a control arm when the desired drug can be had for the asking outside the confines of a trial?
I agree with your statement. And your "why" is well stated.
However, being "inconsistent" will not destroy the clinical trial system, IMHO. Drug trials face that same problem today when the drug at issue is approved for other uses or there are reasonable alternative drugs. (My wife has MS - I am not about to put her in any trial with a control arm.) That did not prevent Tysabri from enrolling and completing the studies. I do not think that allowing drug development companies to expand compassionate use at a profit would end clinical trials as we know them.
DD, if someone you love desperately needed a drug under development and it was in your power to get if for them, would you?
>>This is not crazy, but surely it is radical.
Radical goes both ways. Would you concede that it was "radical" in 1962 to add the requirement that drugs be efficacious?
>>I’ve seen cogent arguments by intelligent posters that the FDA ought not to be in the business of evaluating drug efficacy in the first place ...
I do think that it is beyond argument at this point that our current system is expensive. It is also clear that rational drug policy will never be understood by the common press or public. The press and public displays little or no ability to balance drug risks with disease risk.
Respectfully,
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
AI
