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Blue Ribbon Panel Urges Changes In NIH Conflict Policies
By Rich McManus
Photos by Ernie Branson
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Like a tailor crafting a garment for a customer of unusual dimensions, the blue ribbon panel on conflict of interest policies drafted a custom-made set of 18 recommendations and presented it May 6 to NIH director Dr. Elias Zerhouni and the 88th meeting of the advisory committee to the NIH director (ACD). The new suit a little looser in the middle, a little tighter at the top should not only be more unobjectionable to wear in public, but also be certain to attract and retain the interest of potential employees.
The recommendations, which were unanimously accepted by the ACD, addressed three main areas outside activities, financial disclosure and system management and reform. On the tightening-up side, they impose stricter limits on outside consulting for top-level manager-scientists at NIH, bar those with human-subject responsibilities from holding interests in companies involved in the research (with some waiver leeway possible), and set time and income limits on those who do engage in approved outside activities (with exceptions for outside medical practice, which is encouraged and protected). On the loosening side, they call for NIH scientists to be compensated for teaching, speaking and writing about their work, claim that "there should be no restrictions on royalties received on works written, edited, or published or on income received from patents licensed by any NIH employee who conducted the work as an approved outside activity," and, in recommendation 18, challenge the NIH director to work with Congress and HHS to offer higher pay (more than $200,000) to top-level scientists in order to compete more aggressively in the hiring market.
The recommendations also call for more NIH employees to file annual financial disclosure forms, for ethics rules and training to be made more user-friendly, and for NIH'ers to be more forthcoming in revealing any outside relationships and financial holdings in work products such as publications, speeches and invention disclosures. The complete report of the blue ribbon panel can be found at www.nih.gov/about/ethics_COI_panelreport.htm.
"The panel recognizes that NIH is truly a national treasure," said Norman Augustine, chair of the executive committee at Lockheed Martin Corp. and cochair of the panel, "but we also realize that we could do harm. The rules governing conflict of interest (COI) could be too liberal, such that the credibility of NIH could be damaged. And the rules could be too restrictive, such that NIH couldn't compete for world-class talent, or transfer the fruits of its research to the private sector. We tried to walk a narrow line between these two concerns. We also tried to focus on policies as opposed to specific rules."
Augustine conceded that no set of recommendations would be sufficient to cover all instances: "There are always going to be exceptions, and the NIH director needs authority in these instances. That may be our most important recommendation."
Panel cochair Dr. Bruce Alberts, president of the National Academy of Sciences, particularly credited the input of intramural NIH scientists. "We received a large number of very thoughtful responses," he said. "There was a fair amount of uniformity to them...we feel our recommendations will be favorably viewed by this group." He also noted, "Scientists are honest people; they generally want to do the right thing. They just need to be better partners with the ethics officials."
The panel held five official meetings in its 66-day deliberations.
Augustine elaborated on the panel's balancing act: "Even federal employees deserve outside lives," he noted. "The government doesn't own its employees' minds. Federal workers are entitled to privacy in their lives. But we do need to ask if what they are doing privately impinges on their public work."
Before itemizing each of the 18 recommendations, Augustine offered his own three-point executive summary: 1) Rules affecting outside activities should be considerably tightened and made more restrictive; 2) Disclosure rules need to be quite broad, both internally and externally; and 3) Participation in the scientific community at large should be encouraged. He added, "We could find no fault in NIH leadership's intentions [with respect to conflict policies as they have evolved over the years]."
Augustine conceded that the panel did not consider support staff positions at NIH. "We focused mostly on senior employees the director and his staff, the institute and center directors, deputies, scientific directors, clinical directors and the people who report to them." Other target audiences included those involved with grants and contracts, "financial decisionmakers," and those with human subject research responsibilities.
Of some 5,000 technical and laboratory staff with ancillary roles, Augustine said, "They should be able to act as members of the scientific community without undue restrictions."
The panel found that, of 17,526 employees as of March 2004, only 118 had consulting arrangements with pharmaceutical or biotechnology companies; that number was down from 228 (covering some 365 agreements) in January, Zerhouni reported. "Many scientists terminated their agreements or didn't enter any new ones until this issue was settled," said the director.
The panel was particularly wary of equity as compensation, Augustine continued, and specifically proscribed it in recommendation 3. "The problem with equities is that they essentially make you an owner. Also, there is no upper limit on what the pay-off might be." Perhaps most dangerously, "the return depends on outcome this is where a scientist could exert influence."
Upon completing his summation of all the recommendations, Augustine said, "This issue has had an adverse morale effect, confusion has been widespread, and the rules governing the field have been arcane, though well-intentioned. We think there is room for substantial improvement in conflict of interest policies."
Zerhouni thanked the panel for "an extraordinary amount of work in a short time. I really am impressed with the depth of analysis and debate. I think you're addressing very fundamental changes."
That led to a general discussion of scientific quality of life at NIH; Zerhouni disclosed that one scientific director here had described the many bureaucratic limits, including those on FTE's (number of personnel), as "death by a thousand cuts." ACD member Arthur D. Ullian, chair of the Boston-based Task Force on Science, Health Care and the Economy, urged Zerhouni to undertake what he called "hassle-factor impact analysis" at NIH, examining the many issues engendered by the COI discussion.
For his part, Zerhouni asked the blue ribbon panel to meet one more time "to fine tune the recommendations. I would hate to not have another opportunity to circle our discussions back...we need a reality check, so we're not missing something." Augustine said, at a post-report press briefing, that the panel would comply with Zerhouni's wishes.
Also at the press event, Zerhouni described next steps: "We plan to analyze the report and how it might be implemented, including how much NIH can do, how much will require the interventions of other agencies, like the Office of Government Ethics, and what may require statutory change."
Added Augustine, "We walked a very fine line in balancing restrictions. We don't want a laissez-faire approach, and we don't want a clamp-down. We searched for appropriateness in the level of restriction."
Noted Alberts, on the subject of outside consulting, "People I respect have said that scientists get more (intellectually) out of their collaborations than the company does there's a mutual benefit both ways when it works well."
The COI portion of the ACD meeting ended on an upbeat note as Zerhouni expressed his thanks to the blue ribbon panel. "One of the most satisfying parts of being NIH director is that we can attract great talent to come to NIH and serve for nothing more than cookies." He also cited the 21,000 outside advisors to the agency, scattered across the country: "This is why our country is what it is we couldn't maintain excellence without people like you. We really owe you a tremendous debt of gratitude."
Noted Larry Sadwin, who attended the meeting as liaison from the NIH director's Council of Public Representatives, "I feel compelled to say thank you to NIH employees," whose work has helped him "successfully manage heart disease for the past 23 years." He urged NIH to get back to its work of improving people's health, declaring, "NIH is great, and it can be a bit better."
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