Map of life expectancy at birth from Global Education Project.

Thursday, April 26, 2007

Does your government work for you?

Well duhhh. One salient area in which we frequently discuss this question is, of course, pharmaceutical regulation, and as long-time readers know, the answer in this case is doubly no because the drug industry not only controls the Congress through its powerful PhaRMA lobby, and the FDA Commissioner's office through crony capitalism, (both of which are typical of regulatory practice in the current era), but the industry actually funds the drug approval process directly through "user fees," under the Prescription Drug User Fee Act (PDUFA) bequeathed to us by George Bush the First. He who pays the piper calls the tune, of course, and as Jerry Avorn writes in the new NEJM:

User fees now account for more than 40% of the budget of the FDA division that reviewsnew drug applications. ... Colleagues at the FDA have told me of a worrisome side effect of the PDUFA: the growing sense that the organization is accountable to the industry it regulates. One FDA scientist who was often criticized for being too concerned about drug-risk data was told by his supervisor to remember that the agency's client was the pharmaceutical industry. "That's odd," he replied. "I thought our clients were the people of the United States."

What a naif. Anyway, the PDUFA is up for its five-year reauthorization and, given all the controversy over the past years, there are proposals for some reforms. Continuing its ignominious retreat before the ever-growing power of Stayin' Alive, the New England Journal of Medicine is making more and more of its public affairs-related content available to the masses,* and this week they have done good, I tell yuh, they have done good. You can not only read Dr. Avorn's essay, you can also read an analysis by former Bushista FDA Commissioner Mark McLellan, who not surprisingly is far more sanguine about the current situation, and a third take by Sean Hennessy and Brian L. Strom, who I would classify as responsible insiders who work for the industry and FDA but who recognize the public interest. (And, in a gesture of utmost munificence, the exalted pooh bahs of NEJM will also allow you to read this tangentially related report on drug industry influence over your personal physician. It will be a miracle if it isn't substantial.)

I won't try to make up your mind for you, but . . . oh, what the hell. Proposals for reform don't go nearly far enough. The amount that would be allocated to post-marketing surveillance, post-marketing safety studies, and developing an adequate infrastructure for safety monitoring is a mere pittance compared to what is necessary. Far too little is being done to reduce conflicts of interest in the agency and to reform the standards for approval so that drugs which are no better than, or even inferior to current standard products, with inadequate evidence of safety, are not approved. Nothing is done to redirect resources in drug development toward the public interest rather than industry profit. And so on.

But read the experts, and decide for yourselves.

*NEJM continues to hide its medical research behind the subscription wall, however. Oddly, the British Medical Journal has done the precise opposite. Its research reports are open acccess, but its public affairs reporting continues to be subscription-only. So they're both half wrong.

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