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Zerhouni Discusses Principles of Collaboration at 87th ACD Meeting
By Carla Garnett
Photos by Ernie Branson
On the Front Page...
When the advisory committee to the director (ACD) last met in June 2003, NIH director Dr. Elias Zerhouni described for them his ambitious Roadmap for Medical Research initiative, which embodies the concept of team science. At the most recent ACD meeting on Jan. 12, he expressed great satisfaction that the fall 2003 public rollout of his three-pronged research strategy had been widely reported and enthusiastically received.
In reassuring ACD members that despite recent criticism of some grants and some consultancy arrangements, NIH must not shrink from its duty to provide health research for the benefit of all, Zerhouni also reemphasized a large part of the Roadmap strategy NIH's need to establish and maintain strong collaborations with both public and private sector scientists.
"The public will not be served," he remarked in his state-of-the-NIH report to the ACD, "if we completely eliminate the ability of government scientists to interact with the private sector either non-profit or for-profit in appropriate ways."
Roadmap Hits the Road Running
Describing the media response to the Roadmap public unveiling, Zerhouni said, "I'm told that this was one of the largest press conferences at NIH. Most important, though, was that the stories were accurate and well-reported. In that sense we have done what we needed to do, what you asked us to do in June, which was communicate extensively with multiple constituencies."
There are 28 initiatives in the Roadmap; several have been launched already and all will be launched in the coming months, with the help and guidance of NIDCR deputy director Dr. Dushanka Kleinman, who was introduced as assistant director for Roadmap coordination, a post she assumed on a temporary detail to the Office of the Director.
New ACD member Dr. R. Sanders Williams, a cardiologist and dean of Duke University's medical school, applauded the Roadmap for "making room for mavericks, but providing a structure" for trends in biology.
In a discussion launched by ACD member and former U.S. Sen. Connie Mack on balancing investigator-initiated research and targeted research, Zerhouni explained that 57 percent of NIH-supported research can be classified as so-called investigator-initiated or basic science, 33 percent is research targeted toward a specific disorder, and 10 percent represents research training.
"You can't dictate what will be done and how," stressed Zerhouni. "[However] we can identify grand challenges and let scientists self-assemble research teams."
ACD member Phillip Williams, retired vice chair of the Times Mirror Co., said that communicating to non-scientists about the benefits of basic research versus targeted research will be essential in garnering public support of the NIH research agenda.
People will want to know why you seem to be studying something without a purpose, he commented. "You must communicate the tension [between the two] as you have here."
Issues in the News
In his fourth ACD session as director, Zerhouni took the opportunity to discuss two issues that have gained a lot of attention in the past 6 months, both inside and outside NIH.
In no uncertain terms, Zerhouni said, NIH stands behind its peer-review system, which determines which research grants the agency funds. A model for others in the international research community, NIH's system of evaluating which research proposals are worthy of funding is sufficiently rigorous second to none he pointed out, and its decisions should not be second-guessed. Justification for several NIH-funded grants on such topics as sexual behavior was questioned by some members of Congress, who requested that NIH look into the specific grants and report back.
"We have reviewed this field," said Zerhouni, who explained that each grant cited was examined for public health relevance and each was determined to be quality research whose results would benefit the public. "There is absolutely no evidence whatsoever that these grants are not in the interest of the public. Our peer review system is working. It is actually one of the most comprehensive processes that can assure one that we are performing and funding good science...We found that in every case, when you looked at the details and when you looked at the public health relevance, that there was no question that these grants should have been funded, and should continue to be funded."
Zerhouni also provided details about his response to Congress regarding possible conflicts of interest that were suggested by a December series of Los Angeles Times articles. The stories raised questions about several NIH intramural scientists who receive compensation from outside organizations for consulting on research, and the propriety and public disclosure of such agreements. A thorough review of all outside consulting arrangements by NIH scientists was ordered by the director and is under way. Zerhouni also pointed out that contrary to suggestions by the media reports all of the arrangements had been disclosed, reviewed and approved under existing ethics rules.
Open Doors, Disclose Facts
"The philosophy we used [to answer the allegations] fairly immediately was to be completely transparent and completely proactive," Zerhouni said, noting that his first concern was to refute implications by the articles that patient safety may have been compromised by the relationships. "I'm pleased to tell you," he stressed, "that we have gone through the reviews all the reviews for NIH aren't completely done at this point but for the cases that were mentioned, there is absolutely no indication whatsoever that a patient was harmed because of this relationship. I want the committee to understand that our actions were to, as completely as possible, shed light on the facts alleged, so that we can at least be sure that the reality of conflict was not there."
Beyond patient safety, Zerhouni said his next major concern was the research itself, to determine that no "tainting of the decision-making process" occurred during the consultancies. "In each case we found the appropriate recusals," he explained. "We found no evidence that what was alleged in the [original] article relates to reality."
Still, the director acknowledged the public perception left by such media reports cannot be allowed to impugn NIH's reputation, or impede its mission.
"When you look at the reality, we find very little," Zerhouni said. "However, the fact that the article triggered such a reaction tells you that we have an appearance problem, and not only an appearance problem, but we have a limit problem. Do we have the ability to have our scientists consult without limits limits on time, on dollars, on kinds of relationships? I think that's a valid question."
To address such questions and others involving conflict of interest and human subject research, he has called for an independent committee to look at NIH policies.
"Our mission is too important to have it undermined by the sense that there was no independent review of the process," Zerhouni said. "The situation is not as bad as it was portrayed, but [it] could be improved so that the appearance of conflict is eliminated. We all feel very strongly that collaborations between public and private scientists are important and essential to translating basic science into tangible products, methods and...that there is a way to assure the public of the lack of conflict.
"We are subject to conflicting tensions," he continued. "On the one hand the public expects us to create tangible benefits. Those tangible benefits cannot be created in a vacuum. They have to be created in connection and in conjunction with the non-governmental sector, because of the high level of complexity related to research. That connection needs to be reinforced and appropriately managed. The principles in my mind are full transparency there's nothing in a relationship that should not be done in full light of day, full disclosure, appropriate review and proactive monitoring."
On the Administrative Front
In addition to Williams, another new ACD member attending his first meeting of the group was Dr. Raghavendra Vijayanagar, a cardiovascular surgeon from Florida.
Two newly appointed institute directors were introduced Dr. Story Landis, who took the reins of NINDS last August, and Dr. Jeremy Berg, who claimed NIGMS's top job in November.
Further lauding the agency's "continued success in recruiting outstanding individuals," Zerhouni also announced recent appointees Dr. Norka Ruiz Bravo, NIH deputy director for extramural research, and Richard Turman, NIH associate director for budget. Zerhouni mentioned that NHGRI director Dr. Francis Collins is leading the search committee to replace Dr. Claude Lenfant, who retired as NHLBI director last summer.
Reiterating his commitment to pursue diversity in all aspects of NIH operations not only in research and research training, but also in the workforce Zerhouni also acknowledged a rare honor for a federal agency, an award for best diversity practices that he accepted on behalf of NIH a few months ago. NIH was the only government organization among 2003's 10 recipients, and is only the second federal group so honored.
"I think it is important to continue to pay attention to the need for diversity," Zerhouni said. "There is no greater need for diversity than in health and health research. We are providing research to a diverse population and we need a workforce that reflects that diversity. We are not there yet. There is a lot more to do, but I think the intent and the momentum are there."
Other issues addressed at the meeting include the NIH budget: Zerhouni reported that at the time, NIH continued to operate under a fourth Continuing Resolution, using fiscal year 2003 funding levels. Congress was expected to complete the 2004 budget process before the end of January, he said.
In NIH deputy director Dr. Raynard Kington's report, he gave updates on several administrative fronts, including the NIH steering committee, which employs a 9-member panel of institute and center directors to streamline agency decisionmaking; the administrative reorganization advisory committee (ARAC), whose summer 2003 report was accepted by HHS Secretary Thompson as a blueprint for NIH; and the reactivation of 5-year reviews for IC directors. The review process has been expanded to include Office of the Director components such as the Office of AIDS Research and the Office of Disease Prevention.
Commenting on the strong potential for flat NIH budgets over the next few years, Zerhouni concluded that "scientific opportunity has never been better" and that NIH will be looking to capitalize on "synergy, efficiency and prioritization."
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