Saturday, March 01, 2008

John Roberts - Due Diligence foe?

I have a feeling that Chief Justice John Roberts wouldn't care for aspects of my job any more than I do.

When I heard Nina Totenberg quote Justice Roberts on Wednesday evening: "I don't see what more a corporation can do," he said. "What more can the corporation do other than say 'Here is our policies' and try to implement them?" I recognized a kindred spirit.

Why are we hounding our vendors to send us everything they find regarding adverse events, when no other corporation is? Why are we telling our employees to call in every time they hear Aunt Millie complain about her gout worsening, just because she's been taking our blood pressure drug for 10 years?

Because we have no other ideas on how to get any meaningful safety data, and neither does the FDA. We're using these lame methods to pump up our database with nonsense, to show the FDA what good due diligence we pursue. The high-powered epidemiogist brains at our company and FDA can't imagine a requirement for practitioners to report suspected ADRs, or even serious ADRs, or even FATAL ADRs. No, we're going to depend instead on the screening skills of whoever picks up the phone at our rebate fulfillment centers to recognize when a patient is inadvertantly mentioning something negative, however trivial it may be.

And I think John Roberts doesn't care less if we do all this. We've got our policies, and we're generating lots of meaningless data from them. Big deal. I'd like it if John Roberts or somebody else with influence would require us to stop concerning ourselves with every potential petty interaction with patients, and require us instead to practice real science.

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