Biotech Values

[DewDiligence]

The Abigail arguments—pro and con—were much discussed on this board during the previous iteration of the case. 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?

They wouldn’t, of course; if Abigail got its way, there would be no more phase-2b and phase-3 trials of cancer drugs.

(Now someone will probably want to say that all this is ok because clinical trial sites can be opened in other countries. But with a modicum of thought one can see that this workaround wouldn’t work.)

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—just have the Agency rule on safety and let physicians and patients figure out the rest.

This is not crazy, but surely it is radical.