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Here Comes the NIH Consulting Ban

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Much has already been written about the controversy at NIH around its relatively laissez-faire approach to overseeing potential conflicts of interest on the part of its scientists. It seems clear that either the code of ethics itself, or NIH’s lax enforcement of the code, is responsible for some of the more ostensibly blatant examples of conflict of interest that so famously raised the ire of Congressman James Greenwood (R) from Pennsylvania (see GT July/August 2004 p. 18).

Now that NIH has released a revised code of conduct that, among other things, bars all NIH employees from consulting with or accepting payments from pharma, biotech, or medical device companies, it is tempting to dismiss complaints by senior NIH scientists that they’re being treated unfairly. After all, employees in practically every other branch of the federal government operate under similarly strict ethical guidelines. What makes NIH scientists so special?

I pose that question rhetorically, but I’ll answer it: What makes NIH scientists different is that in most cases (except for when they serve on SBIR review committees, for example) they are not functioning in a regulatory role over the private sector. In contrast to FDA or SEC officials, the primary role of NIH scientists is to pursue research in the public interest. Thus, one could argue that while the potential for conflicts of interest exists, such conflicts are less likely to occur when NIH researchers lack any power over industry.

(For the record, the new NIH ethics regulations prohibit most intramural scientists, all senior officials, and those with authority over grants and contracts from holding stock in drug and biotech companies, and limit other NIH employees to no more than $15,000 in stock in any one biotech or drug company. In addition to prohibiting consulting or payment arrangements with industry, the rules also ban all NIH employees from accepting payments from universities, hospitals, and research institutes that receive NIH funds. Purely academic collaborations are excluded from the ban.)

But if the mandate of NIH scientists encompasses pursuing science in the public interest, then surely that would include advising industry on how best to turn scientific advances into products — as long as proper safeguards were in place to prohibit profiteering. In some highly specialized areas it is not so easy to acquire expertise that scientists — be they in academia or government — have managed to accumulate over many years of following one line of research. It is only practical and efficient, therefore, to provide a defined mechanism for allowing government scientists to advise the private sector, as their colleagues in academia are allowed to do.

Which brings up another point: many NIH watchers have warned of an exodus of researchers to academia or the private sector as a result of the seemingly overzealous approach to ethics at NIH. It is still a bit soon to judge whether the new rules will so affect scientists that they’d be willing to pack up and move elsewhere. The upcoming departure of Lance Liotta and Emanuel Petricoin — the two co-directors of the NCI/FDA Clinical Proteomics Program — to George Mason University in Manassas, Va., this spring may have a lot to do with being put through the wringer during Congressional investigations into alleged NIH ethics lapses last year.

Should NIH researchers pack up and leave en masse to greener pastures? Probably not. Serving as a government researcher should be an honor unto itself, and the quality of research at NIH easily matches or exceeds that of academia. It’s just a shame that the NIH brass couldn’t have dealt more sensibly with the apparent ethics problem by more vigorously enforcing the requirement that all scientists fully disclose their outside interests, and by tightening the rules on oversight of consulting activities.

 

John S. MacNeil, a senior editor at Genome Technology, can be reached at [email protected] His Sense/Antisense column, which covers government research policy and regulatory issues, appears bi-monthly.

 

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