The US Office of Government Ethics (OGE) wants the National Institutes of Health (NIH) to enact far more restrictive conflict-of-interest regulations on outside consulting activities than those proposed by NIH Director Elias A. Zerhouni and a special "blue ribbon" panel of experts. But a leading biomedical and life sciences organization calls OGE's recommendations "disturbing" and "punitive."

Prohibiting NIH intramural scientists from consulting and interacting with colleagues "would certainly drive very talented people out of government service," said Paul W. Kincade, president of the Federation of American Societies for Experimental Biology (FASEB). "It's disturbing. It looks to me as though the Office of Government Ethics has gone from the reasonable to the punitive," he told The Scientist.

The OGE audits and approves procedures used by executive branch agencies to ensure employees abide by federal ethics laws and regulations. An OGE review of NIH's ethics programs, conducted from January through May of this year, concludes that NIH's "permissive attitude toward outside activities" has "played a major role" in creating conflict of interest problems at the agency.

OGE "strongly recommends" that NIH "develop and propose new supplemental standards of conduct specifically to address the kinds of consulting activities that have raised concerns and that pose the unfortunate potential for widespread public questioning of the integrity of NIH employees," wrote OGE Director Marilyn L. Glynn in the July 26 report, a copy of which was obtained by The Scientist.

In June, Zerhouni outlined to Congress a series of proposed measures to address reports that NIH officials and scientists had received millions of dollars in consulting fees and stock options from pharmaceutical and biotech companies. Zerhouni recommended that all senior NIH officials and all employees involved in extramural funding decisions be barred from any paid consulting with industry. Most intramural researchers, however, would be permitted to consult with outside companies, subject to time and compensation limits.

But Glynn questioned this approach. Without tougher standards, she said, NIH "could give the appearance that some level of misuse of office is tolerable."

"Many of the very consulting activities that have become the subject of public controversy have involved intramural researchers," Glynn wrote. "Overall, it appears to us that intramural researchers are more likely to have official duties that directly involve drug companies… than do extramural officials."

Because intramural researchers may be involved in studying the products of particular drug companies, "such research could affect or create the appearance of affecting the interests of those companies or their competitors," Glynn wrote. Accordingly, the potential for conflicts among intramural researchers "may be at least as great, if not greater," than among extramural officials.

"In fact, from OGE's perspective, probably the most compelling argument that can be made for any absolute prohibition on consulting with drug companies is that some NIH officials actually are involved in making clinical decisions affecting the health and safety of patients and other intramural research subjects, and those subjects need to be confident that decisions about their care are free from any potential influence from extraneous business connections," Glynn wrote.

But FASEB's Kincade said any blanket prohibition against consulting by intramural scientists "would be both harmful and unfair."

"They should not label consulting as misuse of office. Interactions between academia, including the NIH, and industry are mutually beneficial and are very important in the translation of discoveries to cures," said Kincade, who heads the immunobiology and cancer research program at the Oklahoma Medical Research Foundation. "It's important for scientists who are doing the experiments to be in close touch with the need and to understand what's involved in translating their discoveries."

In addition to questioning outside consulting, OGE challenged the efficacy of several of Zerhouni's other proposals. These included addressing conflict-of-interest concerns on a "case-by-case" basis, rather than adopting blanket prohibitions, and limiting intramural consulting to 400 hours per year and payments to 25% of the employee's salary absent other "adequate and effective restrictions." Similarly, Glynn said Zerhouni's proposal to expand public financial disclosure "is not a substitute for appropriate substantive standards of ethical conduct."

OGE gave NIH 10 specific recommendations, including the task of developing new supplemental standards of conduct "specifically to address the kinds of consulting activities that have raised recent concerns." The Department of Health and Human Services, NIH's parent agency, is to respond to the recommendations by late September. A follow-up review is scheduled by January 2005, at which time OGE will decide whether NIH's ethics program needs to be completely reorganized.

"We are confident that the strong policies we are developing, in addition to the steps we've already taken, will address the problems identified and look forward to working with the OGE as we finalize the policies," NIH spokesman John Burklow told The Scientist.