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Background Paper. The National Cancer Program: Enduring Issues, by Michael McGeary
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The National Cancer Program: Enduring Issues Michael McGeary The following background paper was prepared by a consultant for the National Cancer Policy Board. It was intended as background for discussion, and does not necessarily reflect the views of the National Cancer Policy Board, the Institute of Medicine, the National Research Council, or the National Academy of Sciences. It is posted as public background information only. The National Cancer Policy Board was established by the Director of the National Cancer Institute in part to advise him on his statutory responsibilities as head of the National Cancer Program. The Board has begun by focusing on several key pieces of a national programcancer care, prevention, and research (NCPB, 1997).
The National Cancer Program formally dates from 1971, when it was created by P.L. 92-218, the "War on Cancer" Act. According to Section 407 of the Act, titled "National Cancer Program":
(a) The Director of the National Cancer Institute shall coordinate all of the activities of the National Institutes of Health relating to cancer with the National Cancer Program.
(b) In carrying out the National Cancer Program, the Director of the National Cancer Institute shall: (1) with the advice of the National Cancer Advisory Board, plan and develop an expanded, intensified, and coordinated cancer research program encompassing the programs of the National Cancer Institute, related programs of the other research institutes, and other Federal and non-Federal programs.
The purpose of this paper is to review the current status of the National Cancer Program, the issues involved in implementing it, and the prospects for reinvigorating it. The approach is historical, because the fundamental issues concerning a "national" cancer program were highlighted in the debate on the National Cancer Act of 1971 and during its initial implementation, and because it is important to ask why the original conception of the program was not realized and gradually lapsed before thinking about whether and how to mount a more active program today.
The first part of the paper will explore what the National Panel of Consultants on the Conquest of Cancer, the original proposers of a National Cancer Program, had in mind in 1970. As we shall see, they touched on some of the most basic and enduring issues in biomedical research policy generally (how much to invest in basic research vs. how much in applied research and development, top-down vs. bottom-up planning and direction, how far a federal agency can and should go in coordinating related activities in other federal and/or state agencies or the private sector, and how much effort a research agency should put into technology development and transfer). The Panel tried to shift the pendulum toward more applied research and development, more active dissemination of state-of-the-art practices, more centralized planning and program direction, and stronger federal leadership of national activities.
The second part of the paper will look at the early implementation history of the National Cancer Program. The concept gradually fell into desuetude.
The third part reviews the status of the program today, beginning with the 1994 report of the Subcommittee to Evaluate the National Cancer Program of the National Cancer Advisory Board, which recommended a revival of the national coordination feature of the National Cancer Program as well as more emphasis on translational and applications research.
The final part reviews key points from the history of the National Cancer Program and summarizes some enduring central issues that will have to be addressed in strengthening and expanding the current Program.
1. Origins of the National Cancer Program
In its 1970 report, the National Panel of Consultants reviewed the impact of cancer and the major advances in fundamental understanding of cancer made during the previous decade, and concluded: "A national program for the conquest of cancer is now essential if we are to exploit effectively the great opportunities which are presented as a result of recent advances in our knowledge. (1) The Panel identified three "major ingredients" in an effective national program: a new independent agency (the National Cancer Authority), a comprehensive national plan "for a coherent and systematic attack on the vastly complex problems of cancer," and expanded financial resources (U.S. Senate, 1970:3-4).
At the present time there is no coordinated national program or program plan. The National Cancer Institute has done excellent work itself and has supported grants and contracts in the scientific community which have resulted in much outstanding work, but the overall research effort is fragmented and, for the most part, uncoordinated. The effort in cancer should now be expanded and intensified under an effective administration charged with developing and executing a comprehensive national plan for the conquest of cancer at the earliest possible time.
Most of the debate leading to passage of the National Cancer Act a year later centered on the advisability of creating an independent National Cancer Authority subsuming the National Cancer Institute and reporting directly to the president, but the debate reflected an underlying difference of opinion about the proper scope of the federal effort against cancer that goes to the heart of what a national cancer program should be. The medical research lobby led by Mary Lasker, which conceived of the War on Cancer, had a strong view about what the program should encompass as well as how it should be carried out, but other groups had conflicting views.
The Lasker forces were one part of the trifold coalition that accounted for the spectacular growth in NIH's budget from the mid- 1950s to the late 1960s (the other parts were supportive congressmen in key legislative positions and strong NIH leadership). (2) Lasker also had access to Democratic presidents. (3) But after 1968, the key congressmen (Senator Lister Hill and Congressman John Fogarty) and NIH director James Shannon were gone. A Republican, Richard Nixon, was president, and federal budget cutting and the New Federalism were in vogue. Growth in the NIH budget, including NCI, halted after 1968. Concerned, Lasker and her associates arranged for a Senate resolution creating the Panel of Consultants and directing it to recommend the measures needed to achieve cures of the major kinds of cancer at the earliest possible moment, (4) and they played a key role in choosing panel members and staff with sympathetic views, including prominent Republicans with close ties to President Nixon.
Although Mary Lasker was widely appreciated for her help in greatly increasing the NIH budget, her views about how that money ought to be used did not coincide completely with those of the biomedical research community or NIH leadership (Strickland, 1972:187,207). Lasker believed there was too much emphasis on research relative to efforts to turn the results of research into practical therapies for patients, and she was impatient with the reluctance of scientists and federal research managers to engage in directed research. Lasker believed that federal health efforts should be much more aggressive in trying to make an immediate difference and boldly marshal the full range of national resources against categorical diseases such as cancer. In other words, compared with what NCI then did, the National Cancer Program should be engaged in a broader and more balanced range of activities ranging from basic research to dissemination of state-of-the-art practices at the community level, and more actively coordinate all cancer-related activities within NIH (not just NCI) with those of other federal agencies, state and local governments, foundations, voluntary, and other nonprofit organizations, and industry.
In addition to calling for an independent National Cancer Authority, a comprehensive national plan, and more funding, the Panel report called for increased support of existing comprehensive cancer centers and establishment of new ones around the country as the best organizational means of carrying out an expanded attack on cancer. Such centers would allow multidisciplinary interaction in both clinical and nonclinical research, teaching, diagnosis, preventive programs, and the development and demonstration of improved methods in the delivery of patient care. They also could work with medical centers and clinics in their areas "to assure the widespread use of the best available methods for early detection and treatment of cancer," and collect data and disseminate useful information to professionals and the public (U.S. Congress, 1970:6).
The original draft of the Panel's report had language about using large-scale planning and management techniques similar to those developed by NASA, reflecting the view of the Panel's staff that medical research was "lacking the organization and discipline necessary to achieve spectacular results in a reasonable time." The scientist members of the panel objected, and words like 'centralized control' were deleted; 'administration' was used in place of management, and the panel's emphasis on the importance of freedom in basic research was explicitly spelled out (Rettig, 1977:100). For example, the recommendation that a comprehensive national plan for a coherent and systematic attack on cancer be developed was modified by the sentence: Such a plan would include not only programmatic research where that is appropriate, but also major segments of much more loosely coordinated research where plans cannot be definitively laid out nor long-range objective clearly specified (U.S. Congress, 1970:3). The report ended up calling for the generous use of grants in order to stimulate continued independent exploration, particularly in those areas where knowledge is not sufficiently mature for a coordinated program aimed at reaching defined objectives, and for reliance in the planning process on the participation of the scientists who will be doing the work rather than hierarchical imposition of a research plan from above. However, the effective use of collective planning does not mean that centralized administration or management of resources should be sacrificed (U.S. Congress, 1970:7).
Opposition to the legislation based on the Panel of Consultants report focused mostly on the provision transforming NCI into an independent agency and came from NIH leadership and the biomedical research community, but there were also serious reservations about the program planning aspects of the bill. For example, Harold Ginsberg, professor of microbiology at the University of Pennsylvania School of Medicine, and Salvador Luria, Nobel laureate and professor of biology at MIT, testified (among others) that the basic knowledge about the nature of cancer was not well enough understood for a large-scale program-planning effort leading to a cure for cancer within a short of fixed time period, no matter how much money was spent (Rettig, 1977:238-239).
The organizational status of the National Cancer Program ended up being a compromise. Instead of a new independent agency, NCI was elevated to a bureau, and the NCI director was made a presidential appointee and given the authority to submit a budget request directly to the president. Another vestige of the original provision for an independent National Cancer Authority was the establishment of the National Cancer Program under which the NCI director was given planning and coordination authority beyond NCI. As quoted above, Section 407 gave the NCI director general authority to coordinate all cancer-related activities within NIH and also with all other governmental and nongovernmental organizations, and went on to give the NCI director a number of specific national program responsibilities, including to:
use the research facilities and personnel of NIH for accelerated exploration of opportunities in areas of special promise.
encourage and coordinate cancer research by industrial concerns.
collect, analyze, and disseminate all data useful in the prevention, diagnosis, and treatment of cancer, including establishment of an international data bank on the results of cancer research wherever conducted.
establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances needed to further cancer research.
support training programs.
call special meetings of the NCAB if needed to avoid delay in acting on a new scientific or technical finding.
Section 407 also created the President's Cancer Panel to monitor the development and execution of the National Cancer Program. In addition to mandating an annual report on the status of the National Cancer Program, Section 407 said any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President by the Panel.
The 1971 act included several additional sections creating new programs aimed at extending research into practice. Section 408 provided for the creation of new national cancer research and demonstration centers for clinical research, training, and demonstration of advanced diagnostic and treatment methods. Section 409 reestablished the cancer control program with a separate appropriation.
2. Implementation of the National Cancer Program
Even before the legislation was signed into law in December 1971, NCI director Carl G. Baker, M.D., began an elaborate program planning effort that culminated in a strategic plan sent to Congress in October 1973 and a five-year operational plan in August 1974. The strategic plan was updated once, in 1974, and rolling five-year plans were issued annually until the mid-1980s (5).
In the first few years, there was extensive input from the scientific community into scientific program contained in the strategic plan for the National Cancer Program. The plan was organized as a multi-level hierarchy of goals, objectives, approaches, approach elements, and project areas. Baker and staff posed the fundamental goal (develop the means to reduce the incidence, morbidity, and mortality of cancer in humans) and developed seven objectives for working purposes. A series of 40 panels involving more than 250 scientists met at Airlie House between October 1971 and March 1972 to identify several approaches to each of the seven objectives, several approach elements under each approach, and multiple project areas under each approach element.(6) The result was summarized in the wheel, a circular graphic that was used to illustrate the conceptual basis for the National Cancer Program (Figure 1).
There were several more rounds of planning involving large numbers of researchers, including cancer control planning sessions held in September 1973 and a major revision of the strategic plan in January 1974 that fed into the first five-year operational plan (NCI, 1974). After that, however, the plan was revised each year by staff. The text began to be repeated from year to year, with just the numbers updated.
The plans explained that the NCI director was also director of the National Cancer Program and responsible for its development and management. That is, the NCI director had two hats. He was head of NCI, the lead federal cancer research agency. He was simultaneously charged with developing [with the advice of the National Cancer Advisory Board] a coordinated program in cancer research and control that includes activities conducted in and out of the Federal Government, to assure the Nation of a well-balanced cooperative program that recognizes the relevant contributions and achievements of the biomedical community (NCI, 1974:1-2).
Most of the reaction to NCI's planning of the National Cancer Program had to do with the dangers of overplanning NCI's own research program. An IOM committee chaired by Lewis Thomas reviewed the National Cancer Program plan and strongly urged that a distinction be made between the majority of cancers, about which basic knowledge was weak and undirected investigator-initiated research projects were the most appropriate strategy, and cancers in which enough was known to benefit from a planned and directed program, such as childhood lymphatic leukemia, Hodgkin's Disease, and Wilms' tumor (7). The plan responded to this issue by explicitly stating that a major part of the program would be continuing full support of research projects generated spontaneously by independent scientists, aimed at broadening the knowledge base with respect to cancer (NCI, 1974:VI-6).
The National Cancer Program concept in the 1971 act went well beyond the traditional directed vs. undirected research issue. First, it called for a greater and sustained effort to identify areas of research in which knowledge has reached a stage where a focused effort might have a significant payoff for control of cancer in man (NCI, 1974:VI-6). This would imply an effort not only to do research but to monitor the results, have criteria to decide when research results are ready to be developed for practical use, and devote significant resources to applied research and development.
Second, the National Cancer Program concept saw NCI, although primarily a research agency, becoming involved not only in the development of research results into practical applications but working with the full range of national institutions involved in cancer in bringing those applications to bear in prevention, diagnosis, treatment, and rehabilitation efforts as part of a national attack on cancer. The National Cancer Program was not supposed to become the national cancer care system but it was supposed to interact enough with the system to improve the delivery of patient care by promoting the use of state-of-the-art treatments by front-line health care providers (8).
The War on Cancer started off with great fanfare. President Nixon signed the act into law just before Christmas 1971, saying there would be progress against cancer because of recent scientific advances and because the law permitted the President to take personal command of the federal effort to conquer cancer so that its activities need not be stymied by the familiar dangers of bureaucracy and red tape (quoted in Strickland, 1972:289). Nixon had already increased NCI's budget by a third ($100 million) in FY 1972. In May 1972, Nixon appointed a new director, Frank J. Rauscher, Jr., recommended by the President's Cancer Panel.
At his first press conference, Rauscher emphasized the new cancer control program, which was to be the main vehicle for translational research and applications work. He said, My philosophy is, let's do what we can do now with existing data. He defined cancer control as demonstrating to the medical community that existing knowledge can be put to immediate use in care of patients with certain rapidly-growing cancers and talked about sending scientists out from cancer centers to community medical institutions to show them state-of-the-art chemotherapy for acute lymphatic leukemia, Hodgkin's' disease, and non-Hodgkin's' lymphoma (NIH, 1972).
In the first year and a half, NCI began a flurry of initiatives, including the designation of the first dozen comprehensive cancer research and demonstration centers and the establishment of 21 grant-supported cooperative cancer research groups, 20 breast cancer screening centers jointly funded by NCI and the American Cancer Society, 10 cancer rehabilitation demonstration-action programs in cancer centers and community hospitals, and a program in which 7 leading cancer centers would develop prototype chemotherapy programs and train physicians in about 120 community hospitals (NCI, 1973b).
The cancer research program expanded greatly in the first few years as funding jumped at nonincremental rates. The rest of the National Cancer Program did not grow at that rate. What happened? First, as Ginsberg, Luria, and other researchers warned in the hearings on the War on Cancer Act, there was still an enormous lack of basic knowledge on which to act. In the first annual report of the President's Cancer Panel, chairman Benno Schmidt (who had chaired the Panel of Consultants), said Of course, we are still far away from being able to put either a date or a price tag on the ultimate conquest of cancer. Schmidt explained there will be no quick breakthrough and work on the cancer problem will take years. He noted concern of researcher that national cancer program planners would not realize vast areas of ignorance (Schmidt, 1973:7):
In the opinion of the Panel, there is no need for this concern. The plan and the program provide for a very large element of unplanned, untargeted, undirected, investigator-initiated science....No one in authority has the nature of this program confused with that of the Manhattan project or the space program.
Secondly, the cancer control program did not become a, let alone the, major thrust of NCI. It turned out that there was also a great amount of ignorance about how to effect change, either in the practices of community physicians or in behavior putting individuals at risk, such as smoking. The demonstration projects often turned out not to be replicable.
Third, the demands of running a greatly expanded NCI demanded much attention, and there were severe limits to the voluntary coordination that the NCI director and his division directors could effect beyond NCI. National Cancer Program gradually shrank to be largely NCI's activities alone. This trend was probably hastened by the natural tendency of NCI leaders to focus their time and energies on sustaining the Institute's budget generally and the number of new and competing NCI research grants in particular and by a realistic appraisal of the limits of voluntary coordination. To put it another way, running NCI is itself a full-time job.
The national planning and coordination effort was not sustained for long. First, as already noted, the extensive use of external scientists in the planning process did not continue after the first revision of the strategic plan in 1974. No mechanism for involving affected organizations as organizations (rather than individual scientists as experts on program advisory and proposal review panels) was ever set up, although NCI has always made efforts to ensure diversity of institutional backgrounds in appointments to the NCAB.
Second, the 1971 act was recodified in 1978. In the process, the language regarding the scope of the National Cancer Program as including other federal and nonfederal programs was dropped (Tisevich, 1996:2621).
Third, there was little national (or even federal) planning and coordination in any case. Although the opening overview of the scope of the National Cancer Program in the five-year plans had a figure showing the various groups included, both NCI-funded and non-NCI-funded (Figure 2), the subsequent chapter describing National Cancer Program coordination did not contain much. They typically listed the cancer-related programs of other federal agencies, then described the NIH, DHEW, and federal interagency committees that NCI officials served on, and had a small section on coordination with nonfederal organizations (the last was dropped after 1982). In 1975, an Interagency Coordinating Committee for the National Cancer Program was set up, chaired by the NCI director, to provide a forum for the exchange of information on the cancer-related activities and policies of Federal agencies (e.g., DOD, USDA, NSF, FDA, NIOSH, CDC) and to promote joint or cross-funded projects (NCI, 1975:VI-15). But the committee was not mentioned in any succeeding plans! Interagency committees with more focus lasted longer (Interagency Collaborative Group on Environmental Carcinogenesis; Interagency Coordinating Committee for Cancer Control and Rehabilitation chaired by the director of the NCI Division of Cancer Control and Rehabilitation), but they did not add up to a comprehensive program. NCI funding of the comprehensive cancer centers was offered as the main form of coordination with nonfederal organizations, although there were some joint projects with state health departments and the American Cancer Society. As time went on, the activities described in the text supported less and less the standard final paragraph in the coordination chapter: The National Cancer Program, by coordinating information exchange and research planning between the Federal and non-Federal participants in the program, helps facilitate a concerted and cooperative effort against cancer.
3. Current Status of the National Cancer Program
In FY 1993, the House and Senate appropriations subcommittees with jurisdiction over the NCI budget called for an evaluation of the National Cancer Program after more than 20 years. The language of the House subcommittee was reminiscent of the views of the instigators of the National Consultant Panel on the Conquest of Cancer:
The Committee notes that since the initiation of the expanded war on cancer in 1971, more than $23 billion has been appropriated for cancer research at the NCI. While the Institute is to be congratulated on many breakthroughs in molecular biology and other basic cancer research areas, the Committee must express its impatience with the lack of overall progress (excerpted in NCAB, 1994:A-1).
The Senate subcommittee was more positive about the achievements of the Program, listing several recent research advances, but it too showed an interest in improved patient care and outcomes. It noted that overall survival rates had improved from 38 percent in 1971 to more than 52 percent, and asked for a plan for future research across the broad spectrum from basic biology to applications and for evaluation of cancer control efforts including the distribution and quality of preventive services, screening, diagnosis and treatment, aftercare, and rehabilitation; and the barriers to state-of-the-art cancer treatments which are detrimental to our ability to adequately address cancer in some populations, particularly minority and older Americans (excerpted in NCAB, 1994:A-2).
The NCAB conducted the evaluation in three phases. In the first phase, six panels of experts met to identify advances over the previous decade and evaluate the potential of that new scientific knowledge in preventing cancer, reducing morbidity and mortality, and improving survival and quality of life (NCI, 1994). In Phase II, the President's Cancer Panel collected information and heard testimony about progress and problems in the Program. In the final phase, a subcommittee of the NCAB reviewed the materials from Phases I and II, and from the Special Commission on Breast Cancer, and reported recommendations for the future directions of the National Cancer Program (NCAB, 1994) (9).
In the executive summary of its report, the NCAB Subcommittee identified six problems hindering progress against cancer, most of which are outside the purview of NCI and research per se (NCAB, 1994:5). One was the lack of national coordination in cancer-fighting efforts in the public, private, and voluntary sectors (10). An absence of coordination of the National Cancer Program (NCP) results in research and service gaps and costly duplication of effort. (11)
The Subcommittee quoted the mandate in the original 1971 National Cancer Act that the NCI director plan and develop an expanded, intensified, and coordinated cancer research program encompassing NCI programs, related programs of the other institutes, and other federal and nonfederal programs, and noted that several years later, the responsibility for other federal and nonfederal programs was removed from the authorities of the NCI director and put in the general authorities of all the NIH institutes.
This Subcommittee believes strongly that the original legislation characterized correctly the broad scope of NCP research-related activities. It is the Subcommittee's view that the NCP extends beyond research to its application to the people and includes all nonresearch, nongovernmental, and community constituents whose actions impact the cancer problem. Better coordination and collaboration among all public, private, and voluntary agencies with cancer related activities are critical if we are to reduce the burden of cancer.
In the body of the report, the Subcommittee took a more positive approach to the coordination issue. It argued that the success of the National Cancer Program is dependent on the entire community, and illustrated the point with its own concept of the National Cancer Program wheel. All the actors involvedindividuals, organizations, and agenciesare arrayed around the wheel (which in a way underlines the complexity as well as the necessity of coordination in impacting cancer at the individual level) (Figure 3compare with Figure 1).
The Subcommittee gave a clearer presentation than the program plans of the early 1970s of the interrelated but different stages involved in the National Cancer Program, and it emphasized that the set of actors is different in each stage (NCAB, 1994:10):
Basic research, the foundation and engine. The key participants are the basic scientists and sponsors who fund their work and the basic research infrastructure.
Translational research, the bridge connecting basic research to its application. This is the stage at which basic science discoveries are first tested in humans and fundamental research becomes a product or service, and the key participants are researchers and their funders, individuals who enroll in clinical trials, and firms, regulatory agencies, and third-party payers who determine whether promising technologies reach the application stage.
Application of research. In this stage, findings that have advanced beyond basic and translational investigation undergo final study in a defined population, and if warranted, dissemination to the general public. The key participants in this phase are not researchers or research funding agencies but pharmaceutical and biotechnology firms, medical providers and third-party payers, legislative, legal, and regulatory institutions, and each individual.
The report also repeated a basic premise of the report of the Panel of Consultants that the NCI-designated cancer centers are a primary vehicle for carrying out the National Cancer Program, along with the community clinical oncology programs and clinical trials cooperative groups. Not only are the centers and related programs a mechanism for relating basic and translational research and research training, they are involved in efforts to apply the results of research through public information and education programs, community outreach activities, and training programs for community physicians in state-of-the-art treatments (NCAB, 1994:13).
The Subcommittee's first recommendation was:
Establish a Presidentially led plan for overall coordination of the National Cancer Program that includes appropriate Cabinet-level representation, criteria for broad participation in Program planning and activities, and re-establishment of the 1971 legislative authority for national coordination of NCP cancer-related research activities of government, industry, and voluntary sectors.
The report contains 36 more recommendations (e.g., for strengthening basic research, translational research, and the application of research), but they do not address the lack-of-coordination problem or clarify further how the broad range of actors that must pull together in a successful National Cancer Program can be better coordinated. That task is apparently left for an NCI director strengthened by restoration of the 1971 coordination authority and energized by a presidentially mandated planning exercise. To date, the legislative authority to coordinate federal and nonfederal programs has not been reinstated.
4. Conclusion
After a brief recap of the main points from the history of the National Cancer Program, this section discusses three perennial tensions that affect the National Cancer Program.
Historical Points
Origins
The impetus behind what became the National Cancer Program was the view among members of the medical research lobby that great advances in the understanding of cancer had been made over the previous 15 years, but NCI was too focused on basic research and not active enough in developing practical applications of research findings of benefit to people or in getting the word out about those applications. The purpose of the Program was to do more than support good basic research but to have an immediate impact on cancer incidence, morbidity, and mortality by building up applied research and development (called translational research and applications today) and actively promoting their transfer into widespread use.
The group assumed there would be strong and sustained public, and therefore political, support for a crash program to conquer cancer on the scale of the Manhattan Project or the Apollo Project.
Although the expansive language about the National Cancer Program remained in the National Cancer Act of 1971, opposition to a crash program and the super agency proposed to carry it out from researchers concerned about feasibility and executive branch leaders concerned about costs and the impact on other research programs led to a compromise on organizational arrangements that left the head of the National Cancer Program in an anomalous position.
Implementation
Over the years the broad conception of the National Cancer Program as the basis for coordinated national action on a broad range of activities faded, and NCI leadership came to focus on NCI's research programs and on efforts to increase funding for undirected basic research. The broad attack on cancer led by the NCI director along the lines envisaged by the Panel of Consultants and its supporters did not eventuate for some very practical reasons.
The NCI director's formal authority to plan and coordinate a national program among other federal and nonfederal organizations withered away.
The rest of the NCI director's special status and authorities (presidential appointment, direct and immediate access to the President through the President's Cancer Panel, the bypass budget, and authority to coordinate cancer-related activities within all of NIH) have not been used much, and NCI generally functions like the other NIH institutes in terms of planning and budgeting.
Current Status
A recent broad-based subcommittee appointed by the National Cancer Advisory Board called for the resurrection of the National Cancer Program to accelerate the transfer of new knowledge to practical use.
The NCAB subcommittee made a number of specific recommendations for improving and increasing basic research, translational research, and work on research applications (and for an increasing budget to pay for it), but although it said there was a serious lack of coordination, it was not very specific about the problems or solutions beyond recommending that there be a new Presidentially led plan for overall coordination and restoration of the NCI director's lost coordination authority.
The current director is undertaking a major reorganization of the NCI (including the Division of Cancer Prevention and Control) and is open to new ideas about strengthening the cancer program and improving quality of cancer care provided to the poor, minorities, and the elderly.
The practical limits to a nationally coordinated program against cancer remain, including lack of knowledge about what works (witness disagreements among organizations about mammography for women under 50), distrust of central direction by voluntary organizations and state and local governments, fragmentation within the executive branch, the taxing demands of managing the NCI itself, and the sheer costs in time and money of continuous comprehensive planning and coordination.
Enduring Issues
How best to distribute types of research at NCI (or anywhere)?
This issue involves the trade-off between investing in basic research versus investing in other types of research, not to mention activities aimed at getting research results into practical use. Although, NCI is one of the largest federal research agencies and has done comparatively well over the years, its budget is always limited in terms of the problems it is trying to solve. What is the appropriate balance between investment in:
basic research (which is aimed at gaining a fundamental understanding of the mechanisms of cancer better to prevent or treat it),
translational research (which is aimed at turning existing knowledge into better prevention and education programs, diagnostics, clinical techniques, etc.), and
applications (which involves transferring research results into practical use)?
The allocation of funds among these categories tends to look different depending on whether one sees the NCI as a research institution or as the nation's lead agency in the fight against cancer. There are always those who think the best way to proceed is to put a greater share of NCI's budget into basic research projects, preferably individual investigator-initiated grants, because that is where significant breakthroughs are likely to happen resulting eventually in fundamental prevention and cures, and there are always those who think that past progress in research is not being used quickly or broadly enough and want to allocate more resources to applied research, development and testing of applications, and dissemination and outreach activities to make more of a difference now.
The appropriate balance among research categories within NCI is also affected by what and how well other organizations and agencies are addressing in the National Cancer Program agenda (see coordination issue below).
? How to translate research into clinical care?
As broadly as the National Cancer Program was defined in the initial planning stages, and it was conceived to be much bigger than the NCI mission, no one ever thought it could or should become the delivery system for cancer care. No matter how much investment NCI or other institutes and agencies make in translational research or in education and demonstration programs on better applications, a number of other organizations affect what is actually done in day-to-day cancer carepurchasers and insurers, providers, other federal agencies (Health Care Financing Administration, Food and Drug Administration, Centers for Disease Control and Prevention, Agency for Health Care Policy and Research, etc.), state and local governments, and so on. This problem is not disappearing. With the advent of managed care, in fact, other organizations are not just regulating cancer care provision but, in their coverage decisions, affecting the amount and kinds of clinical research that can be done and the incorporation of state-of-the-art technologies and techniques into widespread practice. Although NCI might be able to concentrate on its research mission, a National Cancer Program has to actively look for ways to improve technology transfer, that is, disseminating state-of-the-art knowledge and practice into everyday use.
? How to achieve coordination?
Increased national coordination was the least successful outcome of the 1971 National Cancer Act and the National Cancer Program it created. Why is coordination so hard? Part of the answer, graphically illustrated by the National Cancer Program wheel of the NCAB Subcommittee (Fig. 3), is the fragmented and decentralized nature of the system. In addition to NCI and the advisory groups it works under (NCAB and President's Cancer Panel), other NIH institutes and a number of other federal agencies are involved in cancer-related activities one way or anotherAHCPR, HCFA, FDA, CDC, DOD, VA, USDA, DOE, et al. There are, of course, numerous nonfederal organizations and agencies involved at various levels and pointsstate and local governments, ACS and many other voluntary cancer groups, pharmaceutical and biotechnology industries, hospitals and clinicians, employers and insurers.
A second part of the answer is the voluntary nature of the coordination authority granted in the National Cancer Program. The 1971 National Cancer Act did not give the NCI director authority to command anyone else to do anything, and in any case, despite certain expanded formal authorities (bypass budget, President's Cancer Panel access to the President), the NCI director is layered under the NIH director and DHHS. The idea was that sharing information would lead to opportunities for voluntary joint action. It did in many cases, but it was always (and still is) limited by the third part of the answer, the sheer complexity of the problem, lack of knowledge about what is effective to do, and resulting differences of opinion among independent organizations about desirable policies.
A fourth reason for the difficulty of coordination is its high cost, especially in time demands on organizational leaders, versus the expected payoff (given the many constraints already discussed). Informal (and therefore uncounted) coordination occurs through a natural division of labor among organizations who generally know what each other is doing and do not need regular formal coordination meetings. Even as director of the National Cancer Program, the NCI director only has the power to persuade, and a large number of others to persuade. And the director cannot get around potential role conflicts between being director of NCI, with all the vested programmatic interests (and rivalries with other federal programs for budget) that implies, and being director of the National Cancer Program, of which NCI is just one piece.
Although the kind of comprehensive coordination implied by the 1971 National Cancer Act is probably unworkable, the director of the National Cancer Program might be able to coordinate activities in carefully chosen areas by exhortation and education, that is, using the position as a bully pulpit. Could the NCI director exercise leadership in any issues similar to the way a series of Surgeons-General attacked smoking or C. Everett Koop led in AIDS policy, or is the position too layered and too occupied by running NCI itself? This vocal and public role, to be effective, must be careful to focus only on issues for which change is possible, that are clearly important and likely to remain so, and where moral suasion is sufficient for the task (as opposed to bureaucratic or budget authority).
The dilemmas posed by aspirations for a National Cancer Program directly impinge on the role of the National Cancer Policy Board as well, a topic best left to the Board for discussion.
References
IOM (Institute of Medicine)
1973 The National Cancer Program Plan: A Review. Washington, DC: National Academy of Sciences, April 6.
NCAB (National Cancer Advisory Board)
1994 Cancer at a Crossroads: A Report to Congress for the Nation, from the NCAB Subcommittee to Evaluate the National Cancer Program. September.
NCI (National Cancer Institute)
1972 National Cancer Program, Summary of Project Areas Proposed for the National Cancer Plan. September.
1973a National Cancer Program, The Strategic Plan. January.
1973b National Cancer Program, Progress and Achievements. November 9.
1974 National Cancer Program, Operational Plan: FY 1976-1980. August.
1975 National Cancer Program, 1975 Annual Plan for FY 1977-1981. October.
1994 Measures of Progress Against Cancer: Consolidated Report.
NIH (National Institutes of Health)
1972 The NIH Record, XXIV (June 7):1,7.
Rettig, Richard A.
1977 Cancer Crusade: The Story of the National Cancer Act of 1971. Princeton U Press.
Schmidt, Benno
1973 Annual Report of the President's Cancer Panel for 1973.
Strickland, Stephen P.
1972 Politics, Science, and Dread Disease: A Short History of United States Medical Research Policy. Cambridge, Mass.: Harvard University Press.
Tisevich, Dorothy A.
1996 Legislative history of the National Cancer Institute and the National Cancer Program, Cancer, 78(Dec. 15):2620-2621.
U.S. Congress
1970 Senate Committee on Labor and Public Welfare, National Program for the Conquest of Cancer, Report of the National Panel of Consultants on the Conquest of Cancer, parts I and II, 91st Cong., 2nd sess., November.
EndNotes:
(1)The story of the National Panel of Consultants and subsequent legislative history of is well told by Richard A. Rettig (1977). Stephen P. Strickland has a good short account in the last chapter of his post-war history of NIH (1972:Ch.XII).
(2)Strickland (1972) provides the fullest account of how the coalition came into being and operated.
(3)For example, in 1966, she got President Johnson to invite the Secretary of HEW, the Surgeon-General, and the NIH institute directors to the White House. Johnson surprised them by asking whether too much energy was being spent on basic research and not enough on translating laboratory findings into tangible benefits for the American people (quoted in Strickland, 1972:207).
(4)Senator Ralph Yarborough, the resolution's sponsor, told his colleagues on the Senate floor that the goal was to defeat cancer by the nation's bicentennial in 1976 (Rettig, 1977:81). Yarborough and Congressman Claude Pepper, who introduced a similar resolution in the House, also mentioned the Moon-shot analogy.
(5)Before becoming director in July 1970, Baker was associate director for program, responsible for planning and analysis. With Louis Carrese, he developed the convergence technique, an adaptation of program planning techniques from systems analysis to the management of research, which was used in NCI's major directed research programs (e.g., special virus leukemia program in 1964, chemotherapy program in 1965, and carcinogenesis program) (Rettig, 1977:70-71).
(6)There were 7 objectives, 35 approaches, 146 approach elements, and 764 project areas (NCI, 1972).
(7)The Thomas committee mentioned the development of leukemia chemotherapy as a possible example of a problem that might benefit from a centrally managed scientific plan (IOM, 1973:12).
(8)The Program did become the health care delivery system for most children with cancer, however, because there are relatively few of them and they can be accommodated in a reasonably sized clinical trials program and a few specialized medical centers.
(9)The NCAB subcommittee had 15 members from a variety of backgrounds. Five were members of the NCAB (including the chairman), and one was chairman of the President's Cancer Panel. Others were from industry, academia, and the National Coalition for Cancer Survivorship. The results of Phases I and II and the report of Special Commission on Breast Cancer are summarized in appendixes to the NCAB Subcommittee's report.
(10)Other problems included problems with health care insurance; inadequate cancer care, especially for the poor, elderly, and uninsured; and unhelpful or limiting laws, policies, and regulations (the Subcommittee also cited inadequate support of translational and basic research).
(11)In another place, the report said Federal and state cancer research and care programs are not well coordinated and at times work at cross-purposes. Realigning and streamlining these programs and processes must be among the highest priorities in the effort to re-engineer government and private sector cancer activities (NCAB, 1994:9).
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Last Updated: 6/24/2003, 02:26 PM
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