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Conflict Panel Promised Full Access,
Urged Not To Stint on Advice
By Rich McManus
On the Front Page...
The first official meeting of the NIH blue ribbon panel on conflict of interest policies on Mar. 1-2 was remarkably unconflicted as the 10 members probed federal rules governing employees' outside activities with a combination of incisiveness and wit. Their mission is to provide NIH director Dr. Elias Zerhouni with a set of recommendations on how NIH might alter its current policies governing conflict. Zerhouni admonished the group to "leave no stone unturned" and to complete its work not in the original deadline of 90 days, but in 60 days in time for the May 6 meeting of the advisory committee to the NIH director (ACD), of which the panel is a working group.
"Dr. Zerhouni has offered us total access to information," said panel cochair Norman Augustine, a genial corporate titan who chairs the executive committee at Lockheed Martin Corp. "He has offered us total freedom, with no boundary conditions imposed." He then thanked NIH staff for providing each panelist a set of initial documents measuring 18 inches thick. "You can't quite imagine the excitement of reading through these government regulations," quipped Augustine.
Dr. Bruce Alberts, Augustine's cochair and president of the National Academy of Sciences, emphasized that the panel is looking not just into conflicts of financial interest, but also into time spent on outside activities, which he termed "conflict of commitment. Our panel is going to suggest what should be, then let Congress and others figure out how it should happen...We're conducting a sort of zero-based accounting of how NIH should behave." He emphasized that the appearance of conflict will be as important to the panel as the reality.
Zerhouni who welcomed the panel, took questions then left it to complete its work said public trust in NIH is paramount and that the issue of conflict must be addressed "immediately and completely." There are several dimensions, he said, to protecting the public's interest through conducting science of the highest integrity. "The public has the right to see its resources not misdirected for private gain," he said. "There must be a tangible public benefit to the work we do, and it is important for us to be able to attract and retain the best scientists. These three issues are at stake here."
Zerhouni said, "The fact that our scientists are sought after is testimony to the fact that we have the best people. If they weren't the best, no one would be interested in them...That is why we have an issue. NIH scientists are renowned for their excellence and integrity, and we need to minimize barriers to their creativity."
The director acknowledged the need for "full and explicit disclosure" of NIH scientists' outside activities and added "we need a system that will continuously monitor these relationships." But he also noted that there are more than 5,000 scientists in the intramural research programs, and many of them are not involved in allocation of resources. "There is no one-size-fits-all solution to the problem" of conflict management. "The level of scrutiny has to be flexible."
Zerhouni said that many NIH investigators are doing pure research and serving "fundamental roles that no other institution can fulfill." NIH is also doing research with human subjects, which introduces a new level of complication. "A blanket policy of prohibition or undifferentiated response won't capture the complex needs of the public," Zerhouni said, allowing that the public might find such a blanket prohibition "easier to understand." (A temporary moratorium on outside activities at NIH is not a legal option during this period of review, noted NIH deputy director Dr. Raynard Kington.)
Zerhouni emphasized that "conflict of commitment" is a major concern for him, and that a "qualitative approach" must be taken in measuring its impact. "We want public servants to be fully committed to their duty to the public."
Zerhouni concluded by noting that eliminating the appearance of conflict "will be the most difficult part of [the panel's] mission." He also thanked NIH staff for "umpteen hours that you have spent on this issue I am blessed with a staff that really wants to do the right thing. I have encountered no resistance from them."
The panel then dug into the meat of the day, hearing from a slew of federal ethics attorneys who parsed regulations dating back to the establishment of a federal Office of Government Ethics in 1978. OGE periodically reviews the ethics programs at all federal agencies, and happens to be reviewing four NIH components (NCI, NIAID, CC, OD) at the moment, said Stuart Rick, deputy general counsel at OGE. According to Kington, NIH conflict policies are also under review by: the HHS Inspector General's Office, which held its first meeting Feb. 11; the General Accounting Office, acting at the request of Reps. Henry Waxman (D-CA), John Dingell (D-MI) and Sherrod Brown (D-OH); and perhaps most publicly by the House energy and commerce committee's subcommittee on oversight and investigations.
Already in 2004, NIH has: required that incumbents of 93 senior positions at NIH complete public financial disclosures; centralized ethics reviews for all senior officials; established an NIH ethics advisory committee (the NEAC, which has met weekly since Jan. 20 and has a current caseload of 500-1,000 activities); and begun reviews of all biotech/pharmaceutical outside activities since 1999, as well as a review of all ongoing outside activities, Kington reported. Further, OGE has approved NIH's request that, from now on, employees be required to report amount and type of income, compensation, fees, remuneration, expenses or reimbursement to be received for any proposed activity, and to report any past benefits for activities that are ongoing. "In the past, we could not ask for this information," noted Kington.
Attorney Edgar Swindell of the HHS Office of General Counsel gave the panel a detailed statement offering a number of challenging questions for it to consider: Would the panel want to amend the 520 form that evaluates applications for outside activities? Should NIH employees be barred from any biotech holdings or earnings? Would such a ban be partial or total? Should there be a cap on recompense? "An absolute rule," he warned, "might preclude anyone at NIH from accepting a Nobel Prize." Swindell also conceded, "Ethics law can be unintelligible to the uninitiated."
In her historical overview of NIH's ethics program since 1985, attorney Holli Beckerman Jaffe, who is NIH ethics officer (and a former member of Swindell's staff), noted that rules governing outside activities at NIH were quite harsh 20 years ago high level officials here were not allowed to consult at all. She touched on rule changes in 1988, a 1991 honorarium ban (highly controversial at the time, noted panelist Dr. Phil Pizzo, who is now dean of Stanford University's School of Medicine but for many years served as chief of NCI's Pediatric Branch) that was later overturned in 1995, and in 1993, when uniform Standards of Conduct were issued government-wide. Jaffe said an OGE audit conducted at NIH in 1995 found the agency "out of compliance in five major areas," including consulting restrictions that were too broad, and compensation limits that were too restrictive. Given the choice of getting in compliance with the rest of government or seeking "supplemental regulations" for NIH, then director Dr. Harold Varmus elected to stay with the government-wide rules, effectively loosening many restrictions on scientists' outside activities, said Jaffe.
Jaffe emphasized that supervisors at NIH have an essential role in minimizing the possibilities for conflict. "They are really the first line of review with respect to conflict of time commitment," she said. She said there needs to be more dialogue between employees and supervisors before issues of conflict reach a body such as the NEAC.
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