Godzilla versus King Kong: FDA Preemption Meets Comparative Efficacy
Lots of chatter today on the NYT article, linked below, that reports on funds set aside to do comparative efficacy studies in the U.S.. You will note that there is no indication whatsoever about how the resulting information will be used. But we are already hearing dire warnings about the end of the doctor/patient relationship, "rationing" (you're on the iceflow, buddy), and the end of civilization as we know it. Rush hasn't had this intense a day in some time.
Of course, we already have comparative "efficacy": it's called managed care and what your insurance will and will not pay for. It is not based on science. It is based on the lowest bidder and, on occasion, kickbacks. That's how Baycol won the Department of Defense formulary contract, by underbidding the other statins. And that's how we lost a number of good men, and good women.
The real policy questions here are subtle. They will not be solved either by population studies or by disingenuous rants about rationing and socialism. They are issues of policy, ethics, and science. They will require hard thinking, indeed.
In the meantime, it is at least interesting that the same folks who are today hypertensive over the comparative efficacy studies--like Glaxo's leadership--are the first to champion FDA's "expert" and "optimal" weighing of risks and benefits. _Those_ Washington bureaucrats are rightfully uber alles. The ones imagined by the counter comparative efficacy gang are leftist muggers and thieves. (i.e., Canadians). Choose your demons.
Time for everyone to take a deep breath. Medicaid in states like Washington and Oregon did their own comparative efficacy work some years ago. It was not based on cost (despite what its critics say), but on evidence.. That is why a lot fewer people ended up getting Vioxx in those states than in others. And survived.
And, btw, nobody in Idaho or northern California went berserk over this "chaos of conflicting standards."