Great post on the bureaucratic nightmare that is the 'compassionate use' process for using unapproved drugs.
I recently had the misfortune of experiencing the compassionate use process...I did a quick Google search to see how I could obtain IV zanamivir and learned that I needed to contact the drug manufacturer, the FDA and my IRB. I soon learned there were numerous forms to complete, almost all of which required me to record the same information over and over. From start to finish it took approximately 4 hours and the best word to describe the situation was kafkaesque...Maybe I'm just a simpleton, but couldn't there be a website where information is entered once and then routed to the appropriate agencies?...All of this makes me wonder how many patients don't receive treatment with potentially lifesaving drugs because the process is so painful, duplicative, time intensive and byzantine.
Similar byzantine processes exist for things like reporting adverse drug events...you know, not important stuff we don't want to have good data about.