The fight to white out the black box

[biopearl123]

CKTC’s theory about why the FDA came out with guns blazing is interesting. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. We hate being directed by others who have never even seen a patient, are following some notebook algorithm and have no idea what it took to get to be an MD much less a specialist. Heme/Onc docs will be managing Imetelstat, it really would be best to let them do what they do best without a whole bunch of FDA mandated hoops. I repeat my assertion of gratitude that statisticians don’t treat patients. the FDA (and insurers) may feel the need to flex their muscles, they love control, doctors hate it. Release us from the prison of the EMR!! Anyway I thought CKTC’s speculation was pretty right on. As he has pointed out even with approval a black box warning is not the worst thing in the world and as long as good specialists can manage their patients without too many external restrictions.