As reported in the New York Times, the National Institutes of Health (NIH) announced a new supplemental ethics regulation that addresses the concerns raised by the activities of some of its employees, particularly regarding outside consulting with the pharmaceutical and biotechnology industries. The regulation was developed by the Department of Health and Human Services (HHS), with the concurrence of the Office of Government Ethics (OGE), the federal agency that prescribes executive branch-wide ethics standards.

I am against an outright ban on consulting.  While I don’t think every activity should be allowed, I don’t think you can ever completely eliminate conflicts of interest.  It would make more sense to try to effectively manage the conflicts than to ban them completely.  With proper disclosure and oversight, commercial activities can co-exist with academic research.

I suspect, though, that the ban has more to due with trying to put a pristine shine back on research after a few high-profile cases gave consulting a black eye.  Such Dr. Bryan Brewer Jr., chief of the National Heart, Lung and Blood Institute’s molecular disease branch, who published an article on the benefits of Crestor in a medical journal "supplement" that was paid for by AstraZeneca.  In another case, Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the same time that he was collaborating with it in his government capacity of studying patients with Alzheimer’s disease.

Noteworthy is that in Sunderland’s case, he did not disclose his consulting fees despite NIH rules require their disclosure.  This makes you wonder how effective this new ban will have on preventing conflicts.  There will always be some people who won’t follow the rules.

The new regulation focuses on outside activities, financial holdings, and awards for all NIH employees.  Under the new rules, all NIH employees are prohibited from engaging in certain outside employment with:

1) substantially affected organizations, including pharmaceutical and biotechnology companies;
2) supported research institutions, including NIH grantees;
3) health care providers and insurers; and
4) related trade, professional or similar associations.

Investments in organizations substantially affected by the NIH, such as the biotechnology and pharmaceutical industries, are also not allowed for those employees who are required to file public and confidential financial disclosure reports, and are restricted for other staff.

See:  NIH Conflict of Interest Information and Resources and the Federal Register

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