New Conflict-of-Interest Rules Could Jeopardize NIH Mission

Last December, Pulitzer Prize-winning journalist David Willman of the Los Angeles Times wrote an eye-opening report on conflicts of interest at the National Institutes of Health. He revealed that in the decade since former director Harold Varmus liberalized consulting rules, a handful of senior scientists at the nation’s premier health research agency had pulled in hundreds of thousands of dollars in consulting fees from major pharmaceutical firms.

The scandal provoked outraged hearings on Capitol Hill and forced NIH director Elias Zerhouni to appoint a blue ribbon panel to come up with new conflict of interest guidelines for the agency. The panel, chaired by National Academies of Science president Bruce Alberts and Lockheed Martin chairman Norman Augustine, unveiled its proposals Thursday. Sad to report, the proposed guidelines are so lax that over the next few years they could radically transform the agency in ways that will jeopardize its primary mission of discovering the causes and cures for disease.

In defending the proposed rules, Zerhouni said he wanted NIH scientists to be just like their peers in academia, where the bulk of NIH funds get spent. Fearing a brain drain to either flush pharmaceutical firms or universities where lucrative outside consulting deals are commonplace, he said “we want to reinforce the idea of NIH as an academic endeavor.”

This falsely assumes that what is going on at the nation’s medical schools and universities is worth emulating. Since passage of the Bayh-Dole Act in 1980, universities’ biomedical departments have become hotbeds of entrepreneurialism. Any professor with a patentable idea is encouraged to partner with a firm (or create his or her own) to bring the technology to market.

The problem with this gold rush mentality is that it has created an environment where any slight medical insight, not to mention genes, proteins, and biomarkers, have become grist for the patent mill. Researchers who once might have dreamt of saving lives or winning Nobel prizes now dream of privatizing their basic science insights and using them to lure venture capital funding. If you can sell your story on Wall Street, who cares if you’re peddling a speculative theory, or something that even if proven to work would add little or nothing to physicians’ armamentarium for fighting disease?

NIH is supposed to be different. If the agency that spends $30 billion a year in taxpayer funds in the name of curing disease doesn’t uphold the public health mission, who will?

The proposed guidelines could jeopardize that mission in both overt and subtle ways. The advisory panel would allow NIH scientists to earn up to 50 percent of their base salary (which can range up to $200,000 a year) in outside consulting income. It also would allow them to privately patent inventions from this outside work as long as it is “not related” to their primary NIH job.

Imagine this scenario. A few years from now, an Alzheimer’s disease expert at NIH is getting $20,000 a year from several large pharmaceutical firms for helping them develop drugs to combat the dread disease. One day, he gets a call from a researcher at a non-profit institute who thinks he has a new and better approach. This researcher has no money to offer, but he’d like the NIH scientist’s help in reviewing his slides, and perhaps come down to give a lecture to his team.

Will the NIH scientist go? If he goes, will he be able to share all the knowledge he gleaned at the private firms? And once he’s there, will he be willing to admit that, holy cow, this team really does have a better approach and he ought to be working on this (for no extra money) instead of on that private company’s approach where he can continue pulling in $20,000 a year?

Allowing NIH scientists to take on consulting gigs and other lucrative corporate engagements will inevitably cloud their vision. It could wind up making their expertise available only to the highest bidders.

That would be a disaster for public health research in this country. The fact is that what goes on in the market and where the best science is getting done do not coincide.

NIH sits at the epicenter of the U.S. biomedical research system. In its investigations into the causes and cures for disease, it is the one agency that must dispassionately pursue the most promising research paths, no matter where they emanate from and no matter where they lead. It shouldn’t allow its scientists to be distracted by the false signals sent by the promise of private gain.

Posted by gooznews at May 6, 2004 10:09 PM