The Oncologist, Vol. 6, No. 6, 484-485,
December 2001
© 2001 AlphaMed Press
NCI in the Post-Klausner Era
Bruce A. Chabner, M.D., Editor-in-Chief
On a fateful day in our nation's history on September 11, 2001, Rick Klausner, M.D., the Director of the National Cancer Institute (NCI) for the past 6 years, announced his resignation before the National Cancer Advisory Board. His tenure at the NCI began in 1995 in the aftermath of the "NCAB affair," which had diverted the NCI's attention from its research mission to damage control with the nation's press and with Congress hot on its heels. Klausner successfully redirected the debate toward science, and specifically, toward the promise of molecular biology and genetics. With the advice and encouragement of a very supportive NIH director, Harold Varmus, who mobilized budgetary support as never before, the NCI initiated a broad series of research programs designed to take full advantage of progress in cancer biology and genetics. The result was a National Cancer Genetics Network, a "Director's Challenge" in molecular pathology, a significant expansion of the organ specific grants, SPOREs (Specialized Program of Research Excellence), and the anticipated establishment of National Molecular Target Laboratories. The budgetary commitments to these special programs, as well as to the nation's Cancer Centers and Cooperative Groups, may be difficult to meet in the next few years, as the economic downturn and the war on terrorism become unexpected hurdles in the plan to double the NCI budget. Yet no one can doubt the boldness and impact of Klausner's vision. Followed to its conclusion, the plan would define pathology in a new way, would identify new targets for drug discovery and development, and would provide tools for identifying patients at risk of developing cancer and for prediction of treatment outcome. It would indeed change the practice of medicine.
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Richard Klausner, M.D.
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The next director of the NCI will face formidable challenges. As previously stated, the Klausner plan needs to grow and expand into areas of clinical application. Its success is predicated upon the presence of increasing federal budgets. At present, there are clear gaps in our ability to bring molecular medicine to the clinic. In order to make the Klausner plan work, one must invest in the staffing and infrastructure for clinical and translational research. Things do not happen spontaneously in the clinic. Despite the enormous base of support in industry and at the NCI for molecular medicine, academic health centers are having increasing difficulty in recruiting, retaining, and supporting the research of their clinical faculty. At the Massachusetts General Hospital, I can testify to the opportunity and, at the same time, the unmet needs for clinical faculty: time, space, support personnel, and dollars. Our generous hospital, like its partners in the Dana-Farber/Harvard Cancer Center, is committing several million dollars each year in direct support for clinical trials, including some of the most interesting investigator-initiated studies not covered by grants or industry. Although we have the patient population and interest, we simply cannot afford to hire the additional faculty to support the laboratories needed to advance into many promising areas of clinical research. Obtaining NIH support for investigator-initiated clinical trials is both cumbersome and frustrating for young clinicians who are usually beset with clinical responsibilities. The clinical side of research clearly needs attention.
Another challenge for the new director will be to maintain growth in the NCI budget. The National Cancer Legislation Advisory Committee (NCLAC) recently completed a comprehensive report on the national cancer effort in response to Senator Dianne Feinstein's request. The Committee, chaired by former NCI Director Vincent DeVita and American Cancer Society CEO John Seffrin, calls for a broad-based plan for "Conquering Cancer" (http://www.cancersource.com/nclac). Importantly, the NCLAC report backs full funding of the NCI bypass budget, support for careers in biomedical and translational research, and a streamlining of the FDA approval process, but the question remains as to what elements of the plan will have highest priority in a time of limited budget. The plan pays great attention to the implementation of present knowledge for prevention and early detection, survivorship, and palliation, and calls for a major implementing role of the Centers for Disease Control and Prevention, as opposed to the "research" role of the NCI. Thus, if enacted, the plan has the potential for diverting funds from research to implementation and control, a difficult choice in a time of a worsening economy, a flat budget, and a war. There are clearly strong arguments to be made advocating full use of our current knowledge, but a credible argument can also be made that research is a better long-term investment given the modest current success against the common epithelial cancers. We should do both.
Thus the Klausner years clearly prepared oncology for a full-scale application of molecular medicine. The resignation of Dr. Klausner and the attack on America have introduced uncertainty into what seemed to be a well-conceived plan and a relentless march forward from laboratory to clinic. We can only hope and pray for success on both the medical and political fronts.
 
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Bruce A. Chabner, M.D.
Editor-in-Chief
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