Does the US National Institutes of Health fortress need a moat? Credit: NIH

American biotech startups and universities have probably lost the wisdom of government scientists for the foreseeable future. Indeed, if there was any chance that US National Institutes of Health boss Elias Zerhouni might find a way to let NIH scientists consult—without compensation—for biotech startups, or teach courses at American university business or medical schools, it is surely gone now. The latest chapter in the NIH ethics saga has government watchdogs screaming for blood and NIH scientists crying foul and likely headed for the door.

According to a July 8 letter to US Congressman Joe Barton, chairman of the powerful House Committee on Energy and Commerce, Zerhouni acknowledged that of the 81 current and former agency scientists identified by Barton's Committee, 44 had indeed violated NIH ethics rules1. Some of these violations were technicalities, whereas others were more serious. Nine of the 44, in fact, were referred to the US Department of Health and Human Services inspector general's office for possible criminal prosecution.

Up until this point, the most serious allegations of ethical lapses at the NIH concerned three instances of conflict of interest, one of which involved an NIH scientist who was allegedly paid more than $500,000 by a drug company over a five-year period without disclosing it to his bosses2. Anybody who thinks that NIH scientists are of little worth to industry need only look to these examples for evidence to the contrary.

What's more, it is an open question as to whether go-co relationships are really worth protecting.

For the rule-abiding NIH scientists, however, contact with industry and academe can be useful for all concerned. The question is not whether Zerhouni fully appreciates this point. He does. In fact, Zerhouni thinks fledgling biotechs, for example, need more not less help from the NIH. On Wednesday July 27, the Biotechnology Industry Organization (BIO) revealed that Zerhouni is backing BIO's efforts to make NIH Small Business Innovation Research grants available to more biotech upstarts. The more immediate question is whether Washington does, at this point? Another question, of course, is whether yet another layer of ethics rules will actually prevent future misbehavior at the NIH? These rules have been undergoing reformulation during that time because some view so-called 'go-co'—as in, government-corporate—relationships as inappropriate.

What's more, it is an open question as to whether go-co relationships are really worth protecting. After all, experts on matters such as government biomedical research priorities, biodefense or government-industry collaboration trends can be found far and wide—and most biotech startups, professional associations and universities have never turned to NIH scientists for wisdom.

Likewise, it's an open question as to whether America is better off with its public health and biomedical scientists cut off from industry and academe. Insiders say both of these questions are probably academic at this point. Even those at biotech startups who have interacted with NIH scientists, and have defended the value of such interactions in the past, now say it is likely a forgone conclusion that there will be a Chinese wall sequestering NIH scientists.

It seems NIH scientists are already being told to sever ties now in anticipation of the long-awaited new ethics rules governing contact between scientists and industry and academe. These rules have been under consideration for about a year now and were supposed to have been finalized last April.

Hynda Kleinman, chief of cell biology at the National Institute of Dental and Craniofacial Research of NIH, who was elected to serve on the boards of two professional organizations, has been told to sever ties now and ask questions later.

That was my tipping point,” says the NIH's Hynda Kleinman. “I'll be leaving for a university in December.

“I had to resign from both boards,” she says. “The justification was that as a board member I have to make 'fiduciary decisions' such as inviting speakers,” which might be construed as a conflict of interest not least in the cases where speaker fees or honoraria are involved. Kleinman also had to resign from her unpaid adjunct professor position at Georgetown University where she taught one class per year “because [Georgetown receives NIH] grants—and I have a position at NIH—even though I have nothing to do with grants.”

She says she's been told she can possibly reapply for some activities after the new policy manual has been put in place. But, after more than 30 years as a government scientist, Kleinman is not waiting for the next shoe to drop. “That was my tipping point,” she says. “I'll be leaving for a university in December.”

Alan Schechter, chief of molecular biology and genetics at the National Institute of Diabetes and Digestive and Kidney Diseases of NIH, has been at NIH for 40 years and has taught at two nearby universities for the last 25 years. He describes his fellow employees as “demoralized” like never before.

To Schechter, the side effect of greatest concern is that both the small biotech industry and the NIH will be hurt as interaction between scientists is constrained. “If these rules are left standing, our work will have less impact on biomedical research” because we won't know exactly what's happening in industry and vice versa.

Howard Garrison of the Bethesda, Maryland-based Federation of American Societies for Experimental Biology says if the concerns of NIH scientists aren't resolved soon, it could cause “serious problems” for the NIH. He says the inability of scientists at NIH to fully interact with professional organizations, industry and academia could hamper recruiting of new young investigators.

Nonetheless, the public and political pressure on Zerhouni to do something, anything, to assure critics on Capitol Hill and in the media that the NIH takes conflicts of interest seriously is great. Perhaps too great for him to risk his job on rectifying concerns about morale, recruiting or the even more intangible benefits of allowing NIH scientists to interact with industries like biotech, teach at universities or serve upon boards. And those who hope for the contrary are surely bound for more, not less, disappointment.