Biotech Values

[iwfal]

That tweet got hardly any notice, even as respected people on my Twitter stream espoused arguments as though safety and efficacy were independent variables.

FWIW I understood the argument completely, but I didn't respond because:

a) The people making the argument for no efficacy aren't behaving rationally - they have a position and ...

b) Long ago safety trials meant much much less than they do now. And it wasn't like the connection between efficacy and safety wasn't equally obvious then.

c) If you allow surrogates they will exaggerate the efficacy - thus allowing much smaller 'safety trials'.

Yeah, the existing FDA staff may be able to slow things up some - but if the wack jobs take over the FDA leadership I think you'll get a lot of people leaving.