The National Cance Advisory Board (1997)

As Chair of the National Cancer Advisory Board (NCAB), I was pleased that a recent issue of Cancer focused on the 25th anniversary of the National Cancer Act. I was particularly interested in the distinguished Dr. Lawrence's observations on the evolution of the National Cancer Advisory Board.1 Dr. Lawrence invoked the earlier days of the NCAB, and he expressed concern that the Board had diminished in effectiveness. He identified several areas of potential NCAB weakness, and I will address each of these, although in a somewhat different order than his commentary. Dr. Lawrence commented on the following topics: the role of the NCAB in proactive planning, membership, the NCAB's role in secondary review, and its involvement in the bypass budget. Let me assure Dr. Lawrence that no one is more concerned with reviewing the performance of the NCAB and its roles than the Board itself. To that end, we devoted a Board retreat in June 1996 and a follow-up meeting in September to an examination of the appropriate roles of the Board. We agreed that the Board's main roles are in several areas: secondary review of grants, budget and planning, stewardship, and advisory oversight and advocacy. Each of these categories has been defined. Different times call for different boards. The current National Cancer Institute (NCI) budget is more than $2 billion higher than the budget in 1972. 1971 and the years that immediately followed were a time of dramatic expansion at the NCI; the current era is one of more modest growth in the face of increased competition for all government dollars, and external forces in academia and medicine that preclude massive new programs. And even if the budget were available, today's philosophy at the National Institutes of Health (NIH) relies much more on investigator-initiated rather than Institute-directed research. These changes in the scope, magnitude, and maturity of programs and extramural institutions call for a more focused and selective role for the NCAB. Although part of the mission of the NCAB in 1971 was to help establish a course for the NCI in the face of a dearth of knowledge and expanding resources, one of the most important roles for the NCAB today is to maintain the needed oversight to keep the NCI on course and to advise when the course itself needs changes. Thus, part of the NCAB's role in recent years has been to be an integral, if not leading player, in major reviews of the Institute. For example, the NCAB, under Dr. Paul Calabresi's leadership, produced the Subcommittee to Evaluate the National Cancer Program (SENCAP) report, with major recommendations regarding directions for the national cancer program. Dr. Michael Bishop and Dr. Calabresi nimbly led a major review of the intramural program at NCI, which resulted in a landmark report leading to substantial changes in the intramural program, a program that now is stronger than ever. The Board, led by Ms. Zora Brown, Dr. Charles Wilson, and others, took leadership in hosting a conference on minority recruitment and retention to clinical trials and worked with NCI staff to create a guide that has been distributed throughout the country as well as an initiative to provide money for regional conferences to address unique local or regional needs. The Board asked for a review of behavioral research at the NCI and participated actively in both a conference that was held and in making subsequent recommendations. Board members are serving as members of all the working groups and review groups constituted by Dr. Klausner to review major aspects of the NCI and its programs. After each of these reviews, the Board will participate in issues of implementation, just as it is doing for the first of these reports, the one on cancer centers, and in late winter 1997, the NCAB led the process that resulted in NCI's revised mammography recommendations. Yes, the role is different but no less important or needed than the earlier Board role in program initiation. The evolution of the NCAB's role is highly appropriate considering the progress and maturity of our collective efforts against cancer over this period. As an example, the remarkable discoveries in cancer biology and cancer genetics could barely have been imagined in 1971. Dr. Lawrence observed that the secondary review role of the NCAB has become perfunctory and suggested that perhaps it is no longer needed or could be done by another group. He also questioned the ability of current members, especially those without scientific training, to perform secondary review. It would be up to Congress to determine whether the law charging advisory councils with this function should be changed. I, for one, do not believe there is a more appropriate group to perform the review, and the current NCAB takes the secondary review function very seriously. However, the task has grown dramatically in the years since the Act was passed. For example, in fiscal year 1972, there were 322 competing RO1 awards; in 1996, there were 771 awards, comprised of 670 RO1s and 101 R29 awards. This gives some idea of the magnitude of growth. Members continuously evaluate how best to do secondary review in the face of continued growth in the number of applications reviewed every year. Most recently, increased focus and attention have been given to highlighting those applications with scores around and just beyond the expected paylines, to search for those applications that might have special relevance to the NCI, and for cases in which administrative remedies might be identified to prevent ongoing productive research programs from undergoing disruption. Dr. Lawrence may have forgotten that Congress, in its wisdom, never intended that the NCAB or other Advisory Council simply apply the same criteria to applications as primary review panels. It is true that the nonscientific members do not review the grants as scientists; they cannot. It is their expertise as nonscientists that is brought to bear in the review. However, I have been impressed with the diligence of their reviews, and the fact that they often ask insightful, valuable questions that lead to appropriate discussion of concerns. It is the responsibility of the initial review groups to conduct scientific review. The NCAB function is one of oversight and, occasionally, asking broader questions about applications. The legislation mandates a mix of scientific and nonscientific appointments. I believe this diversity is healthy and, ultimately, results in appropriate review. It is part of a much more open, inclusive, multidisciplinary process that characterizes the best science today. Similarly, Dr. Lawrence questioned the credentials of recent appointments. Not wishing to denigrate the impressive membership of the first Board, I nevertheless would call attention to certain facts. The current Board has two Nobel Prize winners, two current directors and a former head of cancer centers, and the President and CEO of a pharmaceutical company with a major interest in cancer therapies, along with outstanding scientific leaders in epidemiology. This is in addition to other excellent members known for their accomplishments in clinical research and excellent nonscientific members who contribute their expertise from the business community and from years of involvement in the cancer enterprise. An examination of the photograph of the earlier Board that was contained in the same issue of Cancer shows how different the Boards were then and now. The current Board is much more diverse in race, gender, and age. That, too, reflects the times. Something may have been lost, but, I believe, much more has been gained. Certainly, as Dr. Lawrence noted, vigilance is required to make certain that the best appointments are made. The issue of how to assure outstanding appointments is a critical one, especially given the various channels through which nominations occur, and the fact that appointments ultimately are made by the President. Dr. Lawrence suggested that the NCAB should be more involved in developing broad scientific policy. At the recent retreat and subsequently, we have been examining the appropriate role of the NCAB in policy. There is little disagreement that this is important, but most of us would probably agree that this needs to be policy qua the NCI, not all cancer activities in the U.S. This larger role, to which Dr. Lawrence alluded, is simply too big for one group or even one Institute to manage on a four meetings per year schedule in addition to other responsibilities. In addition, the President's Cancer Panel has been expected to play a major role in cancer policy. The NCAB has no desire to usurp that role although we have a strong commitment to collaborate with the Panel. Most recently, a National Cancer Policy Board has been established to play a role in larger issues of cancer policy. How the activities of the Policy Board and the NCAB will intersect still remains to be seen. Dr. Lawrence wrote that the NCAB role of late has been to provide outside support for the bypass budget rather than playing a significant role in development or presentation. This is not accurate. In recent years, the NCAB expressed its concern regarding the format and content of the bypass presentation. Under the leadership of Dr. Ellen Sigal, of the Board, a number of recommendations were made to Dr. Klausner to streamline and refocus the bypass report. NCAB members worked side by side with NCI staff and were integrally involved in all facets of the latest and much improved bypass document, and are already at work on the next one. Although consensus will never be universal on all priorities, the Board is proud of its role and will undoubtedly exercise its option of continuing discussion of bypass issues as a regular part of its agendas. Dr. Lawrence also recommended that the NCAB be more involved in presentation of the budget. Although we would welcome the opportunity to meet with the President and his staff, we also recognize the largely ceremonial value of such events. The bypass budget is not only for the President; it is also an educational tool for Congress, the many cancer-concerned organizations, and the interested public, and the NCAB plays an important role in interfacing with these audiences. Finally, Dr. Lawrence argued that the NCAB needs to function more as a Board of Directors, with the additional task of reviewing the Director. Again, this is not how Congress has conceived Institute Councils and the NCAB. According to the legislation, the councils "advise, assist, consult with and make directions to the Secretary and the Institute Director." That means that an effective, collaborative and collegial relationship with the Director is essential. That does not mean mindless obeisance. There is always a tension between the oversight responsibility and the advise/assist roles of NIH councils. Dr. Varmus has established guidelines for the review of Institute Directors, and has made it plain that this is to be done on a regular basis. However, the NCI is not a corporation, and the NCAB is not a Board of Directors in the classic sense. The fact that advisory is part of the name is no accident. Parenthetically, recent discussions in the press have questioned whether corporate Boards of Directors any longer have the intimate knowledge of organizations needed to perform their intended roles. Today's NCAB is different from the first NCAB. Twenty years from now, the times will be different and so should the Board. That is a sign of the vibrancy of our scientific enterprise and of the times. I am grateful to you and the other scientific and public leaders who have contributed so much of their time to so important an effort. Barbara K. Rimer Dr.P.H.