UNDER SIEGE: National Institutes of Health director Elias A. Zerhouni testified before Congress several times (shown here in January) to address charges against the agency. Image: DENNIS COOK AP Photo
"Drastic changes" is how Elias A. Zerhouni, director of the National Institutes of Health, described new rules to address allegations of conflicts of interest at the renowned U.S. agency. Scientists, watchdog groups and the 18,000 employees of the NIH are hoping that the limits, announced in June but still being refined, will quell the scandal, foster impartial research and reclaim the public's trust--without driving away top-notch talent.
The roots of the current trouble reach back to 1995, when then director Harold Varmus lifted restrictions on outside collaboration in a bid to attract top researchers. The freedom allowed staff to work for, own stock in and even serve on the boards of outside companies that they didn't deal with directly as officers of the government, making the agency a much more desirable workplace. Even so, says Paul W. Kincade, president of the Federation of American Societies for Experimental Biology, "it's important to realize that top scientists like Dr. Zerhouni forgo many thousands of dollars in salary to hold a government job at the NIH." Permitting outside income provided an incentive, and disclosure and approval rules seemed adequate to prevent abuse.
Then, in December 2003, the Los Angeles Times reported that many NIH scientists, including institute directors, had been receiving improper consulting payments from drug companies. The fees amounted to millions of dollars over 10 years.
Congressional investigations soon alleged more serious abuses. A clinical trial of a company's drug was apparently derailed shortly after the researcher in charge of the trial received consulting fees from a competing firm. The NIH's National Cancer Institute paid a large legal settlement for a university shortly before the director who approved the payment won a substantial cash award from the very same school. More broadly, a survey of a few corporations revealed that more than one third of the consulting deals between drug companies and agency researchers were never reported to the NIH.
"The conflict-of-interest rules were greatly diminished or weakened," argues Judith S. Bond, president of the American Society for Biochemistry and Molecular Biology, "and there was little effort to enforce those rules." Vera Hassner Sharav, president of the Alliance for Human Research Protection, a group advancing medical ethics and responsibility, puts it more bluntly: "The culture was that they had carte blanche to do as they do and the more research the better--it didn't matter how, what or why. They were simply turning a blind eye and a deaf ear."
Zerhouni, who has been director of the NIH since May 2002, proposed his drastic changes at the end of June. They severely limit who at the NIH can collaborate with private industry and how much time and money can accrue to those who do. Although most researchers would still be allowed to work with drug companies, a single committee must now approve all outside collaboration before it can begin. "Dr. Zerhouni took prompt action, and I think that action is going to go a long way to demonstrating that when there are charges of wrongdoing that are merited, they are even more serious to the scientists than they are to the public," Kincade says.
Others do not think Zerhouni's proposals went far enough. "If they're not mandated and overseen, then they won't change anything," Sharav says. Merrill Goozner, project director at the Center for Science in the Public Interest, a consumer advocacy group based in Washington, D.C., thinks that "there is a good scientific justification--given the NIH's mission--to actually ban all outside consulting and contracting on the part of NIH scientists."
Such concerns have registered at the Office of Government Ethics, which must approve the new regulations. The office's acting director, Marilyn L. Glynn, wrote in a 20-page letter that she contemplated the possibility of an "absolute prohibition on consulting with drug companies." She wrote that the proposals that have been announced to date "could give the appearance that some level of misuse of office is tolerable." Zerhouni's office is working with Glynn's office to develop the "supplemental standards of conduct" that Glynn has called for. Still, Kincade worries that even the restrictions proposed last June "could compromise the ability of the NIH to attract and retain its most valuable assets"--namely, the scientists.