Monday, December 10, 2007

Venturing to Washington I: The Satanic Verses

We ventured down to Washington for the FDA/CMS Summit and while our RPM Report colleagues will undoubtedly share their own thoughts over the next few days, this auslander wants to set down a few of his own.

In perhaps the most entertaining of talks, Regulator-without-Portfolio and Cleveland Clinic’s cardiovascular boss Steve Nissen blasted the FDA leadership for soulless toadying to industry. He started at the top with Andrew von Eschenbach – damned as a close Bush friend (admittedly, from our point of view, hardly a recommendation) and a “urologist” (an apparent reference to some religio-medical schema that blesses the cardiovascular as kosher and condemns the urological as treif).

He was even rougher with Scott Gottlieb, who, disguised as a regulator, apparently secretly serves the Dark Lord. The sign of his sin: pre-FDA, he wrote a newsletter on biotech stocks. That the Satanist Gottlieb no longer ran the newsletter; that as an FDA employee he couldn’t invest in those stocks; that having written about biotechs might actually have helpfully informed a more realistic policy toward the companies who actually create the products on which FDA passes judgment, Nissen did not consider – or at least did not mention.

But parallel Nissenian logic would shackle Alan Greenspan to the economic consulting hell out of which he crept to run the Fed while Robert Rubin would have been stuck arb’ing at Goldman Sachs rather than shaping and running Clintonomics – and few would have said that either man had behaved, once in government, as the corporate lackey he was clearly trained to become.

Don’t get us wrong. We’re as disgusted as most Beltway outsiders by the industry/regulator revolving door, and we nearly joined an atheist chorale when Bush allowed his Zealots (taking a break from bashing stem cell research) to reach into the FDA and, pun intended, neuter Plan B.

But Gottlieb – whose politics we ourselves continue to endeavor to change – was in our view exactly what the Agency needed, helping Mark McClellan open it up, even if just a crack, to the possibilities of adaptive trial design; making the social science of risk communication into a reality in a group which doesn’t much believe in anything but FDA-defined hard science; and—weirdly, given the Secret Industry Program he’s been charged by Nissen with promoting—trying to get some guidelines around conflicts of interest on advisory committees.

And while we can’t say that we regularly carouse with the FDA’s senior careerists, we’ve certainly never heard them bash Gottlieb for trying to impose some right-wing agenda on them. [Disclaimer alert: Scott is a friend of ours and was once very nearly a Windhover employee …which must make us second-order Satanites?]

There is also this odd fact: the Mafia which, the accusation goes, ran/runs FDA for the benefit of Republicans and Big Pharma, approved a mere trickle of new products while wrapping lots of existing ones with new warnings and restrictions. Were these Mammonites merely incompetent at serving their Master?

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