Proposed Revisions to NIH Oversight of Consulting Agreements Inadequate, Office of Government Ethics Says

A proposal announced by NIH Director Elias Zerhouni to revise the oversight system for consulting agreements between NIH employees and pharmaceutical and biotechnology companies would not adequately address concerns about conflicts of interest, according to an Office of Government Ethics report dated July 26 obtained by the Los Angeles Times (Willman, Los Angeles Times, 8/6). Zerhouni in June proposed the revisions to NIH ethics rules in response to months of criticism about how the agency addressed such consulting agreements. In December, a Times article reported evidence of hundreds of consulting payments -- often hidden from the public -- from pharmaceutical and biotech companies to a number of NIH employees.

In response, the House Energy and Commerce Oversight and Investigations Subcommittee began to investigate the allegations. Zerhouni in January directed an NIH Blue Ribbon Committee on Conflict of Interest Policies to investigate the allegations, but lawmakers criticized the recommendations of the committee and proposed NIH ethics rules revisions as inadequate. As part of the investigation, subcommittee Chair Jim Greenwood (R-Pa.) contacted 20 pharmaceutical companies about consulting agreements they had with NIH employees and found that of the 264 consulting agreements reported, about 100 were allegedly unknown to agency officials.

The proposal that Zerhouni announced in June included a number of revisions to NIH ethics rules, such as:

• A ban on consulting agreements between senior NIH officials -- or other agency employees involved in the research grant process -- and pharmaceutical companies, biotech companies and not-for-profit organizations;
  


• A cap on compensation for consulting equal to 25% of the salary of an NIH employee;
  


• A time limit of 400 hours of consulting each year for NIH employees;
  


• A ban on stock options as compensation for consulting;
  


• Limits on stock ownership;
  


• A mandate that NIH employees cannot serve on the boards of directors of pharmaceutical and biotech companies; and
  


• A requirement that NIH ethics officials determine the legitimacy of consulting payments before they are accepted (California Healthline, 8/4).

Marilyn Glynn, head of OGE, wrote in the 20-page report, addressed to an HHS attorney and Zerhouni, that the proposed ban on consulting agreements should apply to other NIH employees, such as agency researchers. Glynn wrote that under the proposal, the potential for conflicts of interest among NIH employees who could continue to participate in consulting agreements "may be at least as great, if not greater," than those to whom the ban would apply. NIH researchers "are more likely to have official duties that directly involve drug companies -- for example, cooperative research and development agreements or other arrangements to use a particular company's products" -- than senior agency officials, Glynn wrote. She added that many of the "very consulting activities that have become the subject of public controversy" have involved NIH researchers.

In addition, Glynn wrote that "time and compensation ceilings alone, or in combination with inadequate substantive restrictions," are not an "appropriate solution" because they could "give the appearance that some level of misuse of office is tolerable." Glynn also wrote that OGE found "significant shortcomings" in how NIH addressed employee requests to participate in outside activities such as consulting agreements; of a sample of 155 outside activities, OGE found that 74 were not approved by the agency in advance. Glynn also rejected a call made by Zerhouni for "case-by-case" evaluations of consulting agreements between NIH employees and pharmaceutical and biotech companies rather than a ban. According to Glynn, NIH has used the practice since 1995, and "experience has shown that the case-by-case approach has not been adequate to protect the reputation of the agency and its employees." In the report, Glynn also requested that Zerhouni and other NIH officials "develop and propose new supplemental standards of conduct specifically to address the kinds of consulting activities that have raised recent concerns" and submit them to OGE by late September. She added that OGE would release a follow-up report within in six months (Los Angeles Times, 8/6).