With health and welfare at stake, I have no problem with higher penalties. The issue with conflict of interest is that they can be abused to a point similar to where the tobacco companies chartered a research institute to develop peer-reviewed science to support their fallacious claims.

http://jhppl.dukejournals.org/cgi/content/abstract/21/3/515

When a doctor receives money from specific companies, and then prescribes their products, how do I know that there isn’t a better treatment out there, or that a generic drug is available that would do as effective a job as the prescribed treatment? I can’t take the doctor’s word on it, and that’s a problem. It’s not just an issue of preventing harm (which the FDA should be able to do through it’s regulation), but of providing the best treatment.

When a researcher is receiving money and doing research on that company’s products, they are much more likely to report positive findings.

http://www3.interscience.wiley.com/journal/118783719/abstract?CRETRY=1&SRETRY=0

So an appearance of a conflict would give the appearance of bias toward a particular outcome. That is a problem because it reduces the possibility that the best outcome for the patient, or the public, will be found. Depending on circumstances, this could meet the standards of willful negligence.

But suppose he had reported the speaking fees. If it appeared to patients that he had a genuine COI, they could have gone elsewhere. But if the “conflict” meant being slightly more prone to use GSK products, so what? The FDA is supposed to ensure that GSK products are safe and medically effective. So to mel, if predisposition to dispense GSK products endangers anyone’s health, its only the doctor’s fault if the products are grossly misapplied.

Say I hire Tiger Woods as a golf instructor, and he says I might want to check out Nike’s line of golf clubs. Could there be a COI? Sure, I guess. Nike clubs might be a little too heavy for me or unoptimally sized. But I would have a hard time saying that Tiger should go to jail for recommending Nike clubs to me, or even that he did anything wrong. I think this is true even if his Nike sponsorship contracts were a big secret. You might say that medicine and science are “more important” than golf, and I agree, but my point is that as long as Tiger is recommending golf clubs to me to use when I play golf, I don’t see a COI which is detrimental to the patient/golf student.

Attracting the attention of Congressional oversight is no small feat, especially in the most recent era of limited oversight. I think the New England Journal of Medicine’s point of view is the right one with respect to conflicts of interest, and it needs to spread.

http://content.nejm.org/cgi/content/full/329/8/570

And yes, I probably favor more punishment than less in these cases on a more…visceral level than anything else.

Although Emory says Nemeroff’s failure to disclose the amounts he received didn’t taint his research or patient care, the university imposes these limitations on his activities: Nemeroff will need to “seek review and approval by the dean’s office of any and all outside compensated engagements before he accepts them,” and he can’t seek National Institutes of Health grants for 2 years. When it comes to speaking at continuing medical education events, Nemeroff will be permitted to talk only at those “sponsored by academic institutions or professional societies.”

1. The article says he accepted speaking fees, not research funding.
2. The article says that his behavior did not taint his research or patient care.
3. The report says that he did violate COI reporting requirements imposed by Emory and NIH.
4. Nemeroff’s excuse is that he did not know he was violating the COI reporting requirements.

How exactly do those facts add up to an ethics violation? I suppose if you take the view that anyone who violates COI reporting requirements in any way is unethical, then Nemeroff deserves his castigation. But I suppose I take the view that “ethical” in these discussions is best used in a philosophical sense, in which case I’m not sure Nemeroff is as unethical as this article makes it seem.

I am certainly not advocating the violation of COI reporting requirements. I think COI reporting requirements are important and can help keep researchers ethical. But when the IRS audits someone it doesn’t necessarily make them an depraved and immoral criminal, and in the same vein, I don’t see how a finding of a COI violation is grounds for us to impugn this guy’s ethics.