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Panel’s Recommendations Urge ‘Sufficient Public Transparency’ in Outside Activities

Judith Randal, Kate Travis

In simpler times, one set of rules might well have sufficed for everyone working in a professional capacity at the National Institutes of Health. But a blue ribbon panel appointed by NIH director Elias Zerhouni, M.D., to help him deal with the agency’s alleged conflict of interest problems has taken a more measured approach. On May 6, when the panel reported to Zerhouni and his advisory council at NIH’s Bethesda, Md., campus, it was to urge NIH to adopt policies that would steer a careful path between its research mission for the benefit of the public and the needs and aspirations of its scientists.



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Dr. Elias Zerhouni

 
"Government ethics rules (applicable to NIH) are complex and not really understood," said Bruce Alberts, Ph.D., president of the National Academy of Sciences who co-chaired the blue ribbon panel, as he opened the public discussion of its 106-page draft document. He and his colleagues found that the agency’s "current rules do not permit sufficient public transparency." On the other hand, they had also found some of the agency’s conflict of interest rules to be so restrictive—or perceived as such by its employees—that they threatened to "soon make it unattractive to be an NIH scientist."

Heading the list of the panel’s recommendations was that NIH scientists in senior management positions at the agency should not be paid consultants to pharmaceutical firms, biotechnology companies, or academia and that paid speaking engagements at industry sites should be off-limits to them as well. Similarly taboo would be industry payments to NIH employees in the form of stock or stock options, as there could be no upper limit on "what the payoff might be" and "this could bias (research) results," said the panel’s co-chair, Norman Augustine, an executive with Lockheed Martin Corp. (Current regulations allow NIH to patent inventions that result from intramural research and the inventor to be paid up to $150,000 a year in royalties.)

Still, the panel recognized that there might be occasions when there is good reason to bend at least some of these rules. Supervisors would perhaps be the best judge of that, Augustine said.

Meanwhile, the panel would grant NIH scientists in less senior positions considerably more leeway. Specifically, they could earn as much as 50% of their base pay extra by consulting for industry or academia—though no more than 25% of it should come from a single source—and up to 100% more than their salaries if derived from direct patient care activities. Furthermore, such professionals would be exempt from the single-source limitation. The panel stipulated, however, that the time spent on outside activities should not exceed 400 hours of the work year—about one day a week.

The panel further recommended fewer restrictions on NIH researchers to discuss their work at scientific meetings, to accept awards for their professional achievements, and to take on writing and editing assignments that draw on their professional expertise. Calling these outside activities "part and parcel of being a part of the scientific community," Augustine noted that "the panel seeks to liberalize rules in these regards."

In the course of its work, the panel discovered a widespread belief at NIH that its scientists, in general, earn much less than their counterparts at universities. "In point of fact, this is not true," said Philip Pizzo, M.D., a member of the blue ribbon panel who is dean of the School of Medicine at Stanford University and himself an NIH alumnus.

Still, NIH salaries top out at $200,000 a year, which some argue is causing morale problems at the agency and depriving it of the services of outstanding scientists. In any case, the panel recommended that the agency work out mechanisms with Congress to enable it to pay top-flight researchers more.

Zerhouni supported this recommendation because, he said, he views it as likely to protect NIH’s long history of taking on problems that the private sector has traditionally been reluctant to tackle, such as vaccine development, orphan disease research, and improving the safety of the blood supply.

"[The NIH] can always recruit scientists," Zerhouni told a press conference after the panel’s presentation. "The question is whether you want a top-notch team or a so-so team" on the job.

Zerhouni voiced his support for all of the panel’s recommendations in testimony before the House Subcommittee on Oversight and Investigations less than a week after the panel released its report. "I find [the panel’s recommendations] to be constructive and a good approach to improve the NIH ethics program," Zerhouni told the committee. "I think that we need to implement the recommendations of the blue ribbon panel ... and do it as diligently as we can."

Some members of that subcommittee were not as supportive of the recommendations.

"The panel’s work was a useful step, but it is only the first step, as the NIH, the Congress, the American public, and interested stakeholders sort out the facts and the issues," said U.S. Rep. James C. Greenwood, R-Pa., chairman of the oversight and investigations subcommittee, which launched its own investigation last June into cash awards given to NIH scientists by companies that do business with NIH. The subcommittee widened its investigation in December after a group of articles in the Los Angeles Times disclosed the consulting arrangements of a few top officials at the agency.

Whereas the blue ribbon panel’s charge was to evaluate the rules and regulations regarding outside activities, the subcommittee is focusing its investigation on "case-specific practices," Greenwood said. "It’s clear from the cases we have reviewed that some NIH scientists are very close to the line or have crossed the line. If we are serious about upholding the highest ethical standards at the NIH, then NIH scientists should not even be close to the line."

The subcommittee planned another hearing on May 18, which was after this issue of the Journal went to press. U.S. Rep. Joe Barton, R-Texas, chairman of the Energy and Commerce Committee, said that the subcommittee will continue to pursue information on consulting agreements and outside activities of NIH employees, regardless of whether that information is obtained cooperatively, or he has to "make them cooperate coercively."

He added, "We have to have transparency, we have to have accountability, and we simply must have the faith of the American people that the research grants that are given at NIH are given because of the merit, not because someone got a big honorarium or speaking fee."

Greenwood acknowledged that NIH has provided the committee with "a substantial amount of information and documents," but their investigation has been hampered by the fact that current rules and regulations do not require all NIH employees to publicly disclose all sources of outside income. As a result, he said, the committee will be sending letters directly to pharmaceutical companies requesting details of their consulting arrangements with NIH employees.

"Although it would be easier, quicker, more satisfying to create a blanket prohibition [against outside activities], the reality is such that you do need to have interactions between scientists and their colleagues both within academia and within industry," Zerhouni said.



             
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