Wednesday, June 22, 2011

Perverse incentives that encourage unethical waste

If you had a federal agency in charge of getting scientific discoveries commercialized, wouldn’t you want them out talking to industry?

So when the agency is NIH, what do they do? Thanks to the 2005 NIH ethics rules, they are discouraged from collaborating with industry.

Derek Lowe writes
The reason I'm talking about all this is that I've heard of instances where people from NIH have refused (or felt as if they have had to refuse) invitations to give talks in industrial settings, because they feared conflict-of-interest problems. This seems perverse, especially for an agency that's talking about getting heavily into translational drug research. That'll have to lead to numerous contacts with industry, I think, in order to be much good at all. So how will the NIH manage that if the drug industry is seen as contaminating their Purity of Essence?
and then in the comments “JAB” replied:
As an NIHer, I pretty much agree with Derek that we're actively discouraged from interacting with industry by the current ethics rules. Formal consultancies were prohibited several years ago, and I don't believe that's changed. Most of my colleagues shy away from anything that might require ethics office approval. It IS possible to give a simple seminar at an industrial site, with prior approval, and I know of folks who do so. Formal collaborations under a CRADA are permitted, but that's two orders of magnitude more work to set up.
I don’t want to minimize the importance of being as blameless as Cæsar’s wife, or the very real problems of any private entity (whether business or activists) illegally influencing government decisions.

That said, the idea of — on the one hand — pressuring (or exhorting) collaboration between government, industry and university scientists to collaborate — while on the other hand adding red tape to make that nigh impossible — is just crazy. Crazy.

And while i understand the central role NIH plays in funding, evaluating and disseminating medical discoveries, they’re not the FDA. It’s one thing to say we don’t want regulators mingling with dirty industry — it’s another to say researchers can’t actually go out and promote real translational research.

It’s not clear how to fix the problem without re-opening the same problems that led to the 2005 rules in the first place. In any endeavor, government regulation and red tape comes along because of a bad apple (or barrel or orchard) that (often) leads to overreaction in the other direction. So eliminating the rules is begging for trouble.

Still, once upon a time the government had rules about de minimis benefits. Is providing someone free lunch in a cafeteria — rather than spending $25 in labor to reimburse a $10 meal cost — really going to lead to unethical outcomes? Some of this is just common sense.

The problem is that some of the outside lobby groups really don't want close industry-government collaboration. (The group pressuring NIH director Francis Collins seems to fit into this category, led by all the usual suspects).

To me, it seems unethical to waste taxpayer money with excessive regulation, delay necessary therapeutics and diagnostics, and even perhaps lead to people dying who didn’t need to.

But then, much as David Friedman points out in his economics primer Hidden Order, people focus on the direct benefit of a given government intervention (e.g. preventing one case of fraud) but not the indirect costs (wasting thousands of person-hours of labor for compliance).

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