Biotech Values

[caravon]

The Abigail arguments

"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 "intelligent" argument doesn't make any sense for two reasons:
1. There are no perfectly safe drugs. There is always trade-offs between drugs' efficacy [aka benefits] vs safety.
A good example will be the entire antibiotics class of drugs. The most of them do have safety issues. But, the offered benefits handsomely overwhelm their safety problems.

2. Most of physicians are not too good and/or very knowledgeable. Now, everyone of them will be in a business to understand and interpret clinical trials? So, shall we allow one semi-blind to guide another blind?

One possibility would be for medical associations to generate diseases treatment guidelines. Taking into account various conflicts of interests, this approach will not work too well. Just look at numerous cases when physicians harm their patients by inappropriately using approved drugs off-label.

At the end, neither of them (physicians and patients) would like to be in such dreadful situation.