It's not just the FDA. These drug companies are run for Investors. They throw around phrases like, "We must follow protocol." "We need to finish the last double blind study."
The truth is they don't want Any bad PR if their drug doesn't happen to work. In my neck of the woods, a lady with Breast cancer was seeking early treatment with a experimental drug through BioMarin. FDA ok it. The Company said No? After reading BioMarin financial statements--I realized how this industry is run; It's about asking money.
(The women realized the drug might not work, and I think her, and her family signed non-disclosure agreements?)
I overheard a MD tell his best friend how to overcome a serious illness, "The Doctor/Friend said you need to believe
the treatment will work." I knew the Doctor was trying to
invoke the Placebo Effect, but I felt it was the best advise
I ever heard from a Doctor. (I know this child's illness
is genetic and I hope the company includes his child in early trials--maybe we can email the FDA?)
I think your characterization of drug companies is unfair.
There are a lot of things that make it tough for drug companies to provide drug for compassionate use (before FDA approval). Often early on manufacturing hasn't been developed enough to make large quantities of drug. If they give drug to everyone who asks for it, they won't have enough to run their trials. What is the impact of that?
I overheard a MD tell his best friend how to overcome a serious illness, "The Doctor/Friend said you need to believe the treatment will work." I knew the Doctor was trying to invoke the Placebo Effect, but I felt it was the best advise I ever heard from a Doctor. (I know this child's illness is genetic and I hope the company includes his child in early trials--maybe we can email the FDA?)