Legislative History of the National Cancer Institute

National Cancer Act

On December 23, 1971, as a result of substantial pressure from research advocates and the Congress, President Richard M. Nixon signed into law P.L. 92-218, the National Cancer Act, a bill that codified the recommendations of the National Panel of Consultants on the Conquest of Cancer, chaired by Texas Senator Ralph W. Yarborough.² This panel of experts was convened by the United States Senate which earlier had passed a resolution calling for a study of the status of cancer research. Choosing to preserve the National Cancer Institute (NCI) as an integral component of the NIH, the National Cancer Act created special authorities that accelerated and enhanced the basic biomedical research efforts already under way and “war” was declared on cancer. These authorities have been “reauthorized” and expanded five times since the original legislation was passed. In reality, the necessary funding for this important priority has not materialized in the years subsequent to 1971. Advocates and scientists today believe that the war on cancer has been nothing more than a skirmish, and that the real challenges of making a national commitment have yet to be met.

Early in the Yarborough Panel’s consideration of what was necessary to revitalize our cancer research efforts, opposition to any alteration of the NCI mounted within the scientific community. The opposition was based on concerns that changes in the authorities of the NCI would weaken the rest of the NIH, that the increase in the cancer budget would be at the expense of other science programs, that the changes would mandate a program outside the integrity of the peer review system, that increased funding for cancer research would result in mediocrity, and that increased research in this area would create false optimism among the general public.³

Changes were made despite the opposition, and the scientific community’s concerns did not prove valid. The integrity of the peer review system has been maintained. The authorities have not weakened the NIH; in fact, several of the authorities have been adopted throughout the NIH. Increased resources for cancer research have caused an explosion of knowledge and resulted in dramatic research advances, not the predicted mediocrity. Further, research funding has grown in all other programs at the NIH over the past two decades (Figure 76.1).

Figure 76.1

National Cancer Institute and National Institutes of Health Appropriations in millions of dollars for Fiscal Years 1985–1999.

Federal Budget Process

The Constitution entrusts to the Congress most of the power necessary to govern the nation, including the powers to tax, regulate commerce, declare war, approve treaties, and raise and maintain armies. In this array of responsibilities, perhaps the most important are the fiscal powers, the ability to alter spending plans and, therefore, define national policy.

Appropriations Committee

The Appropriations Committee in the House and the Senate are the committees responsible for funding federal programs. There are 13 Appropriations Committees in the House and 13 Appropriations Committees in the Senate that annually review all federal programs and make decisions about actual funding priorities within the guidelines established by the Budget Committees.

Once a program has been authorized, through such legislation as the National Cancer Institute Act or the National Cancer Act, it can be funded. By custom and tradition, appropriations measures originate in the House of Representatives, and once the process is completed in the House, they are referred to the Senate for action.

The first step in this process is departmental testimony, when all agency heads, including the director of the NCI, must appear before the Congress in defense of the President’s budget request. Whether they agree with the priorities or not, as employees of the President, they are required to present and support the administration’s budget request at these hearings. Once this testimony is received, participation by the general public is invited. A seemingly endless stream of testimonies from special-interest advocates is presented before the House and Senate committees. While this testimony may make an impact, it is no secret that the crucial impact on this process is the number of constituents of any given member of the Congress who contact him or her, personally or through correspondence, urging the elected official’s support of a specific issue.

When the public witness testimony is completed, the committee members and staff enter a closed room for “mark-up” and begin the arduous task of determining what programs will receive increases and what programs will be cut. Once their deliberations are completed, the bill is referred to the full Appropriations Committee, where it can be amended. If approved, it is sent to the floor of the House, where it can be further amended. When the bill is passed by a vote of the full House, it is sent to the Senate, where a similar process begins. After the Senate has approved its own version of the bill, a conference committee of members of the House and of the Senate meet to work out the differences in the two versions. After the conferees agree to a combined package, it is sent to the floor of each chamber, and voted on. If it is passed by both chambers, the bill is then forwarded to the President for signature into law (Figure 76.2).

Figure 76.2

How a bill becomes a law.

Accompanying the very technical appropriations bill is a committee report, which describes in lay, nonbinding terms the programs being funded and how the committee directs that the funds be used. While not legally binding, the committee reports are viewed as directives from the Congress that provide guidance for agency officials in the expenditure of funds.

Research Funding Trends

Through the 1980s and in the early 1990s the overall effect of congressional budgetary actions has been to limit the growth of domestic expenditures, including cancer research. This has occurred at a time when research opportunities are expanding. In the initial years after the “war on cancer” was declared, funding for cancer research doubled in inflation-adjusted dollars and increased three-fold in actual dollars. From 1976 to 1995, there was little real growth in the cancer research budget, and, in fact, a sharp drop in funding was seen in the early 1980s. In 1980, the NCI’s budget was $985 million. In 1995, it was $2.1 billion. However, the 1995 appropriation reflects a funding level of $972 million in 1980 inflation-adjusted dollars, and only a 1.4% increase over the 1980 purchasing power. Events that unfolded toward the end of the decade would alter this funding pattern and begin the first substantial increases in the purchasing power for the NCI since the late 1970s.

On January 20, 1993, President William J. Clinton was sworn into office; on April 8, 1993, President Clinton presented his first budget to the United States Congress. Included in his first budget proposal were cuts in 9 of the 13 Institutes at the NIH. In addition, to mask the cuts in the remaining Institutes, the president “forward-funded” programs. In essence, he calculated increases that the Institutes were to receive in fiscal years 1995, 1996, and 1997 into the figures for the fiscal year 1994 so that it appeared that increases to select Institutes were provided for. The Congress restored the cuts proposed by the President and provided a 5.2% increase for the NCI. This established a trend throughout the 1990s of the Clinton Administration proposing flat or modest increases in funding for the NCI and the NIH, and the Congress making the bold move to dramatically increase the funding for research. By 1999, the Congress committed to a course to double the budget of the NIH by 2003, and substantial increases in the NIH and NCI budgets were realized (Figure 76.3). Leadership on strengthening our medical research enterprise was clearly in the hands of the Congress.

Figure 76.3

National Cancer Institute statutorily mandated research needs budget as compared with the Administration’s proposal and actual appropriation by Congress.

In the early 1990s several Members of the United States Senate initiated discussions in the Senate Appropriations hearings and on the Senate floor in support of doubling the NIH budget. When the Clinton Administration’s proposal for health-care reform was transmitted to Congress, several legislators, including Senators Tom Harkin (D-Iowa) and Mark O. Hatfield (R-Oregon), developed a proposal to establish a 1% set-aside of health-care premiums to support research at the NIH. These resources were proposed to be additive, not supplanting, the appropriated resources from the American tax payer. Opponents to the proposal, including the insurance industry, immediately called the proposal a tax on the American public. Over the course of that legislative session, the concept gained the support of other prominent figures in the leadership and among the Congressional Committee’s important to the funding of cancer and medical research including, Senator Connie Mack (R-Florida), Senator Arlen Specter (R-Pennsylvania), Congressman John Porter (R-Illinois), and Congressman George Gekas (R-Pennsylvania).

In the 105th Congress, legislation was introduced in the House and the Senate to establish a trust fund for medical research. S. 1411 and H.R. 3030, the National Institutes of Health Trust Fund Act of 1997, amended the Internal Revenue Code of 1986 to disallow a federal income tax deduction for payments to the federal government or any state or local government by tobacco companies in connection with any tobacco litigation or settlement. The anticipated increase in the federal revenue was to be directed to public health. Monies provided to this fund would be distributed by the Secretary, Department of Health and Human Services (DHHS), to the NIH on the basis of the proportion as each receives in the total amount of NIH appropriation.

A second legislative proposal to provide for increased funding to the NIH outside of the appropriations process was introduced by Senators Tom Harkin (D-Iowa) and Arlen Specter (R-Pennsylvania). S. 441, The National Fund for Health Research Act, proposed to increase the funding available to support our national medical research programs through a set-aside or transfer to the Treasury of 1% of the health premiums. Upon its introduction in the United States Senate, Senator Harkin stated that “there’s a lot of talk about the need for the government to act more like a business. And we ought to begin by doing what any smart business would do—invest in research and development. Health research is the key to preventing disease and disability. It is an essential underpinning of quality health care and cost-effective treatments.”⁸

Research Project Grants

In the past decade, funding for NIH programs, on the basis of inflation-adjusted data, has increased, mainly because overall funding for research project grants has grown. This is mainly due to tremendous bi-partisan support for research and innovation in the United States Congress.

Several major policy decisions in the 1980s by the NIH have had a significant impact on funding for research grants in the 1990s. The NIH extended the funding period by increasing the number of 5- and 7-year awards. This decision was made for sound scientific reasons: extending the award period improved the maturation of research data prior to resubmission. When senior scientists with a proven record are not required to resubmit a grant application every 18 months, they can devote more of their efforts to scientific exploration. On the other hand, this grant restructuring necessitated increases in continuation of funds in the additional years to guarantee support, and the increases were not included in the funding base of the NIH. A funding shortfall was “inadvertently” created.

The NIH had traditionally managed most of its grants on a 3-year funding cycle. Continuation costs for many grants suddenly required funding beyond that traditionally planned or provided. In order to meet those requirements, it was necessary to decrease the approval of new grants at the NIH. In addition, Congress stopped mandating a specific number of new grant awards, which, in turn, decreased opportunities for young investigators to obtain funding. New and competing grant awards at the NIH dropped from 6,446 in 1987 to an estimated 6,031 in 1995. Furthermore, any additional resources appropriated by the Congress were directed to the shortfalls in research grants, necessitating virtually no-growth budgets in practically every other funding mechanism throughout the NIH. By the mid-1990s all other program mechanisms were starved for resources needed to address emerging research opportunities.

Additionally, the NIH was forced to implement a policy of “downward negotiations”, which in the mid-1990s became “administrative adjustments”—or mandated cuts—in new and noncompeting grants, in order to meet its fiscal commitments. These administrative reductions are considered a normal part of the grants review process, and they typically range from 10 to 15% below the level approved by peer review groups (Table 76.1).

Table 76.1

Administrative Adjustments in RPGs.

When the National Cancer Act was enacted in 1971, 45% of approved grants were funded. In FY 1999, the NCI will fund 31% of approved grants. Under the Administration’s proposal for FY 2000, the NCI is anticipated to support 28% of the approved grants; however, it is widely anticipated that the Congress will increase the funding of the NCI above the Administration’s request, and that the number of approved grants funded will be sustained at their current level. It is the belief of the cancer research community that if the funding level for research grants envisioned at the time the National Cancer Act was enacted, a 45% success rate, the political will to fund cancer research must be re-energized in the United States.

Public Policy Factors Affecting Medical Research

Several major trends have hampered the funding and implementation of cancer research over the past decade. If these trends are left unaltered, their impact is expected to increase and to have a detrimental effect on the future of investigator-initiated research.

Targeting Research

The early 1990s gave rise to a strong grassroots movement by women advocating for breast cancer research. The National Breast Cancer Coalition (NBCC) led an effort to enlist women throughout America in advocating for increased funding for breast cancer research. In 1992, when the Congress was considering FY 1993 spending priorities, all 435 members of the House of Representatives and one-third of the Senate were running for re-election in what was dubbed “the year of the woman,” and many candidates were looking for the support of women voters. It was in this political climate that the breast cancer advocates put forth their initial efforts which have been sustained by a tremendous grassroots movement.

Clearly, breast cancer activists achieved results. Congress directed the NCI to increase efforts in research in breast cancer, as well as prostate and ovarian cancers, by $100 million. Unfortunately, an increase of only $30 million was provided to the NCI, and cuts in existing cancer research programs were necessary to address the new mandates from the Congress. This was the first time that cuts in ongoing cancer research programs were mandated to provide increases for other cancer research initiatives. The programs that were cut are shown in Table 76.2.

Table 76.2

Cuts in 1994 Cancer Programs.

This congressional directive brought breast cancer research spending to $196 million at the NCI, which was less than the $365 million urged by the NBCC. As a result, many members of the cancer research and advocacy communities, scientists, and lay advocates alike, worked with congressional supporters to identify a source of new funds to preclude the need to further reduce existing cancer research programs. During consideration of the 1993 Department of Defense (DoD) Appropriations bill on the Senate floor, Senator Tom Harkin (D-Iowa) put forward an amendment to increase funding for breast cancer research within the DoD by $185 million, to bring the total breast cancer research program in DoD to $210 million. Known as the “Harkin Amendment for Breast Cancer,” it was passed in the Senate by a vote of 89 to 4.

In the debate during consideration of this amendment, Senator Harkin clearly outlined his intent to have these funds made available to the cancer research community by the Department of the Army in collaboration with the NCI and the NIH.

Subsequent to the passage of the amendment, the Department of the Army contracted with the Institute of Medicine (IOM) to make recommendations on how the DoD should manage its $210 million breast cancer research program. The report recommended that a two-tiered peer review process be established by the DoD for scientific and technical review and Advisory Council review to determine program relevance. In addition, the following program investments were recommended: training and recruitment, $27 million; infrastructure enhancement, $21 million; and investigator-initiated research, $151 million.

This laid the groundwork for the establishment of the Department of Defense Congressionally Directed Medical Research Program (CDMRP), an unprecedented partnership among the military, scientists, physicians, and advocates. In this program the Congress earmarks funds to enhance research in prostate cancer, ovarian cancer, breast cancer, osteoporosis, neurofibromatosis, and DoD women’s health. The program differs significantly from traditional biomedical research programs, yet it maintains high standards in the scrutiny of peer review. In reality, it was the CDMRP which pioneered the incorporation of advocates in peer review. The Breast Cancer Research Program, CDMRP, established the concept of breast cancer advocates having a “seat at the table” of peer review. The result has been a program of vision which fosters new directions, addresses neglected issues, and brings new investigators into the field of breast cancer research. Since its inception, there have been over 1,400 awards made and a total of $868 million provided by the Congress to this program. Award mechanisms include academic awards; IDEA awards; clinical translational research; career development; institutional training; infrastructure enhancement; and cancer center awards.

As the fiscal constraints continue to grow, it is imperative to present a united front with regard to advocacy for cancer research priorities. Gains may be illusory and counterproductive when cuts are forced in existing programs or increases are targeted in only one area over all others in cancer research. Some would argue that real breakthroughs are not likely to come from targeted initiatives, but rather from basic research, as they have in the past. What the 1990s have clearly established is that resources must be made available to enable a balance in these two important priorities. Advocates, both lay and scientific, must be challenged to clearly articulate the importance of both priorities.

Public Policy Factors Affecting Costs of Treating and Preventing Cancer

The escalating cost of health care in the United States is having a staggering effect on cancer care. Health care costs account for over 13% of the gross national product (GNP), the highest for any developed nation. Expenditures for cancer care exceed $107 billion annually, and over half of these costs are related to the treatment costs of breast, lung, and prostate cancers. The overall economic cost of cancer in the United States (including lost wages and the like) is still higher, and that does not take into consideration the human costs, which are incalculable. Ironically, we invest only 2.3% of cancer’s health care costs into research to find effective prevention measures, treatments, and cures for cancer.

Efforts to control costs have been and will continue to be scrutinized by legislators and policy analysts. In 1983, a prospective payment system (PPS) was put in place by the Medicare program in an effort to provide economic incentives that would encourage cost-effective patterns of care. This shift, from a cost-based system to a cost-reimbursement system, has been a fundamental change within our health-care system, as it provides for a fixed reimbursement for services rendered under Medicare. The PPS was established to meet several critical goals of the Health Care Financing Administration (HCFA) to address escalating health-care costs. Specifically, the HCFA’s intention was to establish an incentive-based system to manage health-care expenditures in individual hospitals and to implement a cost-efficient system that would not detrimentally affect access to care.

The PPS altered economic incentives for hospitals providing care to persons with cancer. In order to stay within the reimbursement levels of the PPS, a variety of changes in the delivery of care were necessary, including decreased length of stay; increased use of outpatient services and day hospitals for chemotherapy and surgical procedures; shifts in staffing patterns, both nursing and medical, to accommodate sicker patients in outpatient settings; and increased acuity in home-care programs.

Unfortunately, the advent of the PPS brought to the forefront many complex issues related to the delivery of care that it was attempting to make more cost efficient. Implementation brought with it greater public scrutiny and interest, greater congressional interest and oversight, and more concern about quality of care than had previously existed. As mentioned earlier in this chapter, in 1997, the Congress instructed the HCFA to devise a proposal to move the PPS system into the outpatient arena. Much of cancer care has been moved from the inpatient setting to unique and comprehensive outpatient clinics where sophisticated and advanced cancer treatments could be administered. If the Congress does not address this situation, the HCFA’s proposed changes in the prospective payment system would require significant reductions in the operations of cancer care in the outpatient setting over the next 5 years.

Beyond questions of how cancer care is structured is the underlying issue of how state-of-the art cancer care is accessed. Throughout the 1990s access to clinical trials was considered by the Congress as a public policy issue. Innovative cancer therapies are available through the mechanism of clinical trials that has been put in place in cancer centers, community clinical oncology programs (CCOPs), and cooperative groups across the United States. It is through the mechanism of clinical trials that new therapies are evaluated and proved. This approach has given us cures for such illnesses as Hodgkin’s disease, testicular cancer, and childhood leukemia. Traditionally, Medicare and other insurers have paid for the costs associated with clinical trials, but not for the experimental therapy itself. Trends emerging in the late 1980s and 1990s indicate that third-party reimbursement for clinical trials is being denied in a rather arbitrary and intermittent manner on the grounds that such treatment is “experimental” or “investigational.” Experimental exclusion clauses in insurance policies are intended to protect patients from therapies not supported by the medical community. Unfortunately, in the late 1980s and throughout the 1990s, insurer’s have used this clause to preclude subscriber’s participation in clinical research investigations. To minimize the impact of this practice and to establish a higher standard for private insurers, the NCI and the Department of Defense entered into an agreement, whereby CHAMPUS beneficiaries can participate in NCI-designated clinical trials.

Clinical trials provide the best available treatment for many persons with cancer, and they are considered by oncologists as integral to the provision of cancer care. Reimbursement denial for participation in clinical trials has precluded participation in clinical research by the adult cancer population. While over 70% of children diagnosed with cancer participate in clinical trials, it is estimated that only 2 to 5% of adults participate in clinical trials. This has resulted in a slowing of research translation and detrimentally impacted our ability to provide cost-effective therapies and to advance medical science through the collection of data on state-of-the-art cancer care.

Participation in clinical trials is of paramount importance to older Americans diagnosed with cancer. In 2000, Medicare will provide health-care coverage to 39.8 million people age 65 years and over, the population at increased risk for developing cancer. The median age of diagnosis with cancer is 68; about 60% of all cancers are diagnosed in persons age 65 years and older. Medicare beneficiaries account for more than half of all cancer diagnoses and 60% of cancer deaths. Not only is this age group at greatest risk, it is also the fastest growing segment of the American population as the “baby boomers” will cause a doubling of the over-65 population in the next 30 years. Because treatment of cancer in older Americans is often complicated with comorbidities, which make some therapies that are effective in younger individuals inappropriate for older Americans, it is important to evaluate new therapy options in this population.

With the inauguration of President Clinton came his expressed intent to reform the health-care delivery system. He designated Hillary Rodham Clinton to chair the White House Health Care Reform Task Force and to develop the administration’s blueprint for health-care reform. In November 1993, the administration presented to the Congress a conceptual package that included some of the most fundamental reforms of health-care delivery ever envisioned.

As proposed, the Health Security Act incorporated support for patient-care costs associated with clinical trials as a discretionary benefit in the basic benefit package. Specific criteria addressed the parameters of this coverage, if offered by the insurer to the subscriber. Thus, coverage of patient care costs were not required, but if they were provided, a federal standard was established. Only “qualifying investigational therapies” were to be covered. Qualifying was defined as any investigational treatment whose effectiveness has not yet been determined and is under clinical investigation as part of an approved research trial. An “approved research trial” was defined as one “approved by the Secretary of the Department of Health and Human Services, the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, the Secretary of Veterans’ Affairs, the Secretary of Defense, or a qualified nongovernmental research entity as defined in guidelines of the National Institutes of Health, or a peer-reviewed and approved research program as defined by the Secretary of Health and Human Services, conducted for the primary purpose of determining whether or not a treatment is safe, efficacious, or having any other characteristic of a treatment which must be demonstrated in order for the treatment to be medically necessary or appropriate.”

In the second session of the 103rd Congress, health-care reform legislation was proposed and considered over a 12-month period by no less than seven committees in the U.S. House of Representatives and the U.S. Senate. Owing to the complexities of the Administration’s proposal and the variety of proposals introduced on both sides of the aisle in the House and the Senate, the following major committees ended up with jurisdiction over health-care reform: House of Representatives Ways and Means Committee, Energy and Commerce Committee (particularly its Health and the Environment Subcommittee), Education and Labor Committee, Judiciary Committee; U.S. Senate Finance Committee, Labor and Human Resource Committee, Judiciary Committee.

To deal effectively with the potential impact that health-care reform would have on the delivery of cancer care, the cancer research community developed and advocated for a Statement of Principles that supported cancer research. Under the umbrella of the National Coalition for Cancer Research, a national coalition of 20 research, professional, and lay organizations, the cancer research community worked with the Congress to urge consideration of the following principles as key to any reform measure: (1) access to and the right to choose appropriately trained specialists in cancer management; (2) support for an expanded basic and applied research effort; (3) coverage of investigational therapies as a basic benefit; and (4) support for the unique costs of cancer treatment in a research setting.

While many aspects of the bills introduced and considered by the Congress were of major importance to the delivery of cancer care in the United States, the two key components directly affecting the ability to support research were reimbursement for investigational therapy and the Health Research Fund. These legislative initiatives were included in all the major bills considered, including S.2351; S.2296; H.R. 3600, Ways and Means; H.R. 3600, House Leadership Substitute; and Admt. 2560, Senate Leadership Proposal.

Because of the broad nature of the administration’s proposal to completely alter the delivery system, and the various interests of the congressional committees and subcommittees in different aspects of health-care reform, compromise on a final package and floor consideration of a final health-care reform bill never materialized.

Since the consideration of health-care reform, no legislative vehicle has been enacted to address the dilemma in clinical research. To date, policy makers have been reluctant to require third-party payers to provide coverage for patient-care costs associated with approved clinical investigations. In the 106th Congress, there was growing unrest with managed care among the general public, so several proposals to reform the managed-care delivery system and Medicare were introduced by the House of Representatives and the Senate. Several of these proposals have included provisions for clinical trials, many have not. Specifically, S. 381 and H.R. 1628, the Medicare Cancer Clinical Trials Coverage Act of 1997, were introduced in the House of Representatives and the Senate. The legislation would establish a demonstration project to study and provide coverage of routine patient-care costs for Medicare beneficiaries with cancer who are enrolled in approved clinical trial programs in the Medicare program under Title XVIII of the Social Security Act. In addition, several managed care bills have been introduced in the 106th Congress which include provisions for clinical trials, including: S. 1344, the Patients Bill of Rights Plus Act, was passed in the Senate in July 1999. The legislation addresses coverage for the 48 million Americans in self-insured ERISA plans and excludes the more than 112 million Americans enrolled in group and individual plans. The bill was passed by a vote of 53 to 47, with only Senators Chafee (R-Rhode Island) and Fitzgerald (R-Illiois) crossing party lines. The legislation includes a provision for clinical trials which would mandate coverage of routine patient-care costs for trials approved by the NIH, NCI cooperative groups, the Department of Defense (DoD), and the Department of Veterans Affairs. In addition, the legislation calls for a negotiated rule-making process to define “routine patient costs” in clinical trials. H.R. 2373, the Bipartisan Consensus Managed Care Act, sponsored by Congressmen Charlie Norwood (R-Georgia) and John Dingell (D-Michigan), was passed in the House on October 7, 1999?. The bill requires reimbursement of patient-care costs incurred in approved clinical trials for life-threatening diseases. Approved clinical trials are those sponsored by the NIH, the Cooperative Groups, the DoD, and the Department of Veterans Affairs.

The Congressional Budget Office (CBO) has presented initial data which have deterred full consideration of the clinical trials reimbursement issue for both Medicare beneficiaries as well as privately insured individuals. When legislation is introduced in the Congress, the CBO must analyze the legislation for cost implications, in order to alert legislators with regard to how much a specific bill is likely to cost the federal government and establish when it is necessary to find “offsets” for those costs. In the case of the clinical trials legislation, the CBO has indicated in meetings and discussions with legislators the data that it would use to determine their cost assumptions for the clinical trials issue. The CBO has indicated that costs to Medicare are likely to double if payment for participation in clinical trials is required, since 50% of Medicare clinical trial claims are not submitted by physicians. In fact, the NCI indicated that of the 36,000 patients enrolled in clinical trials sponsored by the NCI’s clinical cooperative groups, approximately 16,000, or 44%, are Medicare beneficiaries. Therefore, a substantial number of Medicare beneficiaries already participate in clinical trials. The CBO has also indicated that clinical trials typically cost 10% more than traditional care. In data recently presented by cancer research experts on Capitol Hill during the “Cancer 101” Briefing Series on Clinical Trials, clinical trials were identified as costing less than standard treatment (Table 76.3 and 76.4). The last of the CBO’s reported assumptions is that, on average, individuals participate in clinical trials for 2 years. In fact, this is not substantiated since most clinical care provided in clinical trials occurs within 6 to 9 months.

Table 76.3

Costs Comparison of Clinical Trials vs. Standard Care*.

Table 76.4

Cost Comparison of Standard Care vs. Clinical Research.

Several studies are being prepared for publication that address the issue of costs, in order to debunk the myth that care provided in a clinical trials setting increases costs to the health-care delivery system. When those data are available to the Congress and the CBO, a re-evaluation of the cost estimates will need to occur, in order to have broad support of these provisions within the Congress.

Tobacco And Research

In the 105th Congress, numerous bills were introduced outlining a “comprehensive” tobacco settlement. Previously, the state Attorney Generals (AGs) had reached an agreement with the tobacco industry, which established a 65-cents-per-pack increase for tobacco, and it was estimated that this tax would generate approximately $368 billion over 25 years. The settlement reached by the AGs assumed that the bulk of these resources would be directed to the states. Turning to the Congress, they requested federal intervention in guaranteeing the objectives of this settlement and ratifying the tax issues relative to the settlement. This request opened the door for intensive debate and discussion within the Administration and the Congress with regard to the distribution and allocation of the tobacco revenues and the best approach to achieving the public health objectives identified by the AGs in their original agreement.

Many Members of the Congress, the Administration, and advocates believed that federal legislation should provide for increases in research funding. The Clinton Administration initiated the specifics of the debate when they proposed that the FY 1999 increases for medical research at the NIH and prevention and control programs at the Centers for Disease Control and Prevention (CDCP) be financed with tobacco tax revenues. The bar was quickly raised in a variety of legislative proposals which ensued. In the Senate, several bills proposed increasing the appropriation for the NIH over the next 5 years, utilizing tobacco revenues. S. 1638, the Health Kids Act introduced by Senator Kent Conrad (D-ND), proposed that a portion of the funds be earmarked for tobacco-related research and cancer research as well as providing funding for cancer clinical trials. S. 1648, the Preventing Addiction to Smoking Among Teens Act introduced by Senator Jim Jeffords (R-VT), proposed that $12.5 billion of the revenues raised under the act be directed toward establishing a Tobacco-Related Research Initiative and an Office of Tobacco-Related Research in the NIH to be headed by the NIH Director. In S. 1889, the Kids Deserve Freedom from Tobacco Act of 1998, Senator Tom Harkin (D-Iowa), a longtime advocate for the NIH, proposed that $16 billion be directed to the NIH over a 5-year period in a formula that would require that the funds be additive to, not supplant, baseline funding for the agency. In the House, Congressman Vic Fazio (D-California) introduced HR 3474, the Healthy Kids Act, which proposed NIH fund increase over a 5-year period to be based on a percent of fixed payments. The bill included specific earmarks for tobacco-related and cancer-related research and for cancer clinical trials. Support for a legislative remedy eroded when it was clear that the public health community was pushing for tobacco control parameters and regulation, which many felt went beyond the original agreement struck by the tobacco industry with the AGs.

In November 1998, 46 states settled lawsuits that they had filed against the tobacco companies. These settlements were precipitated by the threat of federal intervention going far beyond what had been agreed to in the original settlement. However, it appears that many of the states which ratified the settlement have failed to address the tobacco control needs which initially prompted the settlement. Of the 27 states that have taken action on the settlement to date, only six—Hawaii, Maryland, Minnesota, Vermont, New Jersey, and Washington—have appropriated funds for a comprehensive tobacco control program. Ten other states have dedicated funds for tobacco programs at levels that are well under the CDCP recommendations. Of the total $7.3 billion in initial payments to the states, only $290 million will be directed toward tobacco prevention and control.

THE MARCH: Coming Together to Conquer Cancer

In September 1998, “THE MARCH: Coming Together to Conquer Cancer”, an unprecedented grassroots movement, was undertaken by the cancer community. THE MARCH, united cancer survivors, cancer researchers, families with cancer, and the general public in a urgent campaign to place the prevention, treatment, and cure of cancer at the top of the national agenda. In preparation for THE MARCH, the Research Task Force comprising 164 experts was created. The Research Task Force identified both the exceptional opportunities that exist in cancer research today and the incredible barriers which preclude us from fully exploiting these research opportunities. The recommendations developed complement the NCI’s bypass budget and provide a strategic plan for cancer research efforts. The experts who participated in this panel believe that it is of paramount importance to address the recommendations of the report, in order to prevent cancer from crippling the health-care system as the aging population increases. Conservative estimates project that by 2010 cancer will become the leading cause of death. The incidence of cancer will increase by 29% and mortality will increase by 25% at an annual cost of over $2 billion. The key recommendations of the Research Task Force are summarized below:⁹

• Double the NCI budget for FY 2000 and increase it to $10 billion by 2004, in order to bolster funding for basic research and discovery by funding a minimum of 45% of approved cancer research grants in areas including translational, psychosocial, and behavioral research, molecular epidemiology, environmental carcinogenesis, and cancer in minority and underserved populations.
• Develop newer and better cancer therapies to capitalize on exceptional opportunities in cancer therapeutics by developing public/ private consortiums to accelerate the development of new cancer therapies.
• Improve early detection by developing improved methods of early detection, improve access to early detection programs, and implement a national cancer program in screening and risk profiling.
• Support aggressive cancer prevention efforts by implementing a national research and education initiative in tobacco control, doubling funding for basic clinical and behavioral cancer research, creating cancer prevention “centers of excellence,” developing chemopreventatives, and partnering with industry to perform the large and expensive chemoprevention clinical trials.
• Improve quality of life for cancer patients through increased support for basic behavioral and psychosocial research, pain research, end-of-life research, and training programs in psychosocial and behavioral oncology research.
• Fully engage the private sector in cancer research through collaborative programs, tax credits, and targeted grants.
• Develop and implement a national system of clinical trials to increase trial participation from 2 to 10%, by requiring third-party payers to cover routine patient-care costs, and doubling funding for the Cooperative Groups.
• Train clinical scientists in oncology through 5-year renewable grants and increase funding for R01 grants to clinical investigators.
• Re-invent the NCI by removing policy constraints and increasing the flexibility and response capabilities of the NCI.

National Dialogue on Cancer

In 1999, the American Cancer Society (ACS) established the National Dialogue on Cancer (NDC). This ongoing national forum, co-chaired by the President and Mrs. George W. Bush, brings together the principal leaders of national organizations and recognized figures in the lay public. Senator Dianne Feinstein (D-CA), serves as Vice Chairman of the NDC. A broad representation of the public, private, and nonprofit sectors is included in the membership of the NDC, including cancer survivors, heads of government agencies, leaders of national organizations, elected officials, cancer experts, executives of major pharmaceutical companies, and recognized media figures. It is the intent of the NDC to develop a lasting plan to eradicate cancer as a major public health problem. The leaders of the NDC seek to identify barriers, gaps, and opportunities related to eradicating cancer; establish agreement on critical national priorities; and facilitate independent and collaborative efforts to achieve these goals. The underlying principles of the NDC are as follows: A commitment to research as the engine that drives our increased understanding of the disease Americans fear most. A commitment to working together to address cancer issues that would not be effectively dealt with by the collaborating partners (participants) separately. A moral obligation to reach all people, with special attention on those at greatest risk and, in particular, ethnic minorities and the medically underserved who disproportionately carry the greatest burden of cancer. A staunch dedication to primary cancer prevention and early detection as well as access to quality cancer care and quality of life for all who develop the disease

A pledge to close the gap between knowledge and its application to people at the community level where millions of lives are being lost needlessly. A charge to re-energize the United States to find ways of controlling cancer as a major public health problem as early as possible¹⁰

The NDC has created numerous Priority Teams to develop recommendations and marshal the necessary tools and national capacity to eradicate cancer in the next millennium. The Priority Teams include private research; nonprofit research; public research; primary prevention; early detection; patient empowerment through outreach and education; access to health (cancer) care; access to quality care; and surveillance. Each of the teams has developed individual strategic plans during the first year of the NDC’s activities. Cross-cutting strategic activities, addressing population disparities, renewal efforts relative to a revitalized National Cancer Act, and special surveillance activities, are underway to integrate the overall action plan of the NDC (Figure 76.4).

Figure 76.4

Priority teams established by National Dialogue on Cancer.

Analysis

Annually, over 1.2 million people in the United States are diagnosed with cancer (excluding the common skin cancers), and it is expected that one out of every three Americans will be diagnosed as having cancer at some point in life. One person dies of cancer every 56 seconds.¹¹ That equates to 1,500 deaths every day and 563,100 deaths annually—the equivalent of the population of one congressional district. As Donald Coffey, PhD, former President of the American Association for Cancer Research (AACR) puts it, the lives lost in five 747 jumbo jets crashing every day for 1 year equals the 563,100 Americans who will die from cancer this year.

Another way to understand the impact of the disease is to compare the number of Americans who die of cancer with the number of American service personnel killed in battle. In all our nation’s wars combined (from the American Revolution to the war in the Persian Gulf), a total of 652,799 battle deaths have been recorded. Thus, the number of Americans killed in battle during all of our 215-year history is only 89,699 more than the number of Americans killed every year by cancer. These data reflect the grim statistics of cancer and create compelling evidence that cancer research efforts are as important today as they were 20 years ago or at any other time in the past.

In 1971, with the passage of the National Cancer Act, it was widely believed by the American public, as well as by many in the Congress, that with a little extra effort and money, cancer could be eliminated. In fact, in the fanfare associated with its passage, the Congress unanimously passed a resolution calling for an end to cancer by 1976 as an “appropriate commemoration of the two-hundredth anniversary of the independence of our country.”⁶ The Congress’s commitment to eradicate cancer was genuine; its expectations were unrealistic.

In the years that have followed the passage of this landmark legislation, it has been widely recognized that the “war” has not been won. That cancer was not cured by the 200th birthday of the United States is stating the obvious. Many believe that the absence of total victory has diminished, albeit unconsciously, a willingness to commit fiscal resources for our National Cancer Program. Because of the inability to claim total victory against cancer, the public and the Congress have been less willing, and at times altogether unable, to recognize the tremendous successes derived from this landmark legislation. Two decades after the passage of the National Cancer Act, one can make a compelling argument that the Act strengthened all of biomedical research, gave birth to the burgeoning new industry of biotechnology, and unlocked many secrets of the workings of the cancer cell. Most importantly, it has enabled tremendous lifesaving advances with positive impact on the lives of millions in this and future generations.

The resources directed to the Act have had a direct impact on the lives of over 8 million cancer survivors. Many cancers, such as leukemia, lymphoma, Hodgkin’s disease, cervical cancer, and childhood malignancies, that were almost always fatal are now most often curable. The NCI-supported research in testicular cancer has led to a 91% cure rate. Adjuvant chemotherapy, a direct result of the innovative drug research supported under the National Cancer Act, has decreased the recurrence rate and the mortality associated with many cancers, such as breast cancer.

The importance of the ability to cure many cancers is matched by the equally important success in maintaining the highest quality of life for those afflicted with the disease. Surgical procedures, which in the past compromised the ability of cancer patients to return to active, productive lives and which often led to severe psychologic problems due to disfigurement, have been ameliorated significantly. Today, multi-modality therapy, incorporating surgery, radiation therapy, chemotherapy, and frequently immunotherapy, is often the standard treatment. Women with breast cancer and their physicians now have a choice of effective procedures and, in many cases, may select treatments that conserve the breast. Children and young adults afflicted with soft tissue sarcomas are now spared the removal of their affected limb, through advanced surgical techniques used in conjunction with radiation and chemotherapy.

Furthermore, research has improved the quality of life for those undergoing treatment for many cancers, by controlling more effectively nausea and vomiting, as well as the immunosuppressive side effects. Because of innovative techniques in pain management, patients no longer need fear the pain that once seemed an inevitable consequence of cancer.

Perhaps, then, the flaw in the war against cancer was declaring it a war in the first place. Addressing the rising incidence of cancer, advancing our understanding of the disease, and establishing a network to ensure access to innovative therapy for all Americans afflicted with cancer were moral responsibilities that the government properly undertook to combat the disease its citizens fear most. Those responsibilities have not diminished.

When the National Cancer Act was passed, the National Panel of Consultants highlighted the inadequacy of funding for cancer research. In 1969, for every man, woman, and child in the United States, $410 was spent on national defense and 89 cents for cancer research. Today, we are spending $1,200 per person on national defense and $7.41 per person for cancer research.

In their 1971 report, the National Panel of Consultants questioned the allocation of national priorities. In 1999, that question remains on the table. Priorities today, as in 1971, are out of balance. Thirteen percent of the GNP, over $900 billion, is spent on health-care costs, such as medication, syringes, and hospitalizations, while only 0.3% of the GNP is spent on medical research. From 1980 to 1989, research and development in the DoD increased 89% in real dollars. In contrast, research and development in domestic programs, including medical research, decreased by 9% in real dollars.¹²

To reverse this trend, it is imperative to understand how the process of allocating dollars works and where the scientific and medical community must make an impact. It has been stated that “to stimulate federal support of medical research and education . . . requires voluntary expenditures of time and energy, cultivating Senators and [members of] Congress, educating them and creating forceful advocates for medical progress.”⁶

The past decade of fiscal constraint has placed the biomedical research community in a false dilemma by seeming to pit science against science. The idea of pitting one disease or institute against another is counterproductive and shortsighted, and the medical research community should avoid being caught in this trap. Medical research, including cancer research, is crucial for the advancement of the biologic sciences and for the hope that those advances will prevent or cure diseases and disabilities. On that merit alone, funding should be a national priority.

In recent years, the principal target of much of this debate has been AIDS research. Since 1984, when the first congressional appropriation for AIDS was provided, total United States funding to meet the demands of this epidemic has grown in excess of 2000%. Whether or not this funding would have been provided to other biomedical research programs is irrelevant, although many believe that the NIH would not have received so large an increment for any other reason. What is important to learn from this is that when the Congress and the Administration are forced by public sentiment to find the resources to meet a crucial need, the resources are found.

Annually, hundreds of thousands AIDS activists have taken to the streets in Washington, D.C., drawing public, congressional, and media attention to funding needs of the AIDS epidemic. This is not unlike the scenario that occurred when the National Cancer Act was passed in 1971. The Citizens Committee for the Conquest of Cancer, established by Mary Woodard Lasker, took out full-page advertisements in the New York Times. In bold print, the advertisements declared, “Mr. Nixon, you can cure cancer,” and then went on to describe how that could be achieved.¹³ Visibility, media attention, and public sentiment can influence fiscal priorities. When legislators are made to understand that an issue is important to their constituents, it becomes their priority also. The breast cancer advocates remain the primary cancer advocacy group that has successfully taken a page from this book, their mobilization of a grassroots effort has been nothing short of spectacular.

Members of the cancer research community need to apply the lessons learned from the successes of the Citizens Committee for the Conquest of Cancer and from the AIDS and breast cancer activists. One important way to start is by urging the Congress to increase support for the NIH. Dr. Lewis Thomas once stated, “If you are looking about for examples of things that the government can do, and do beautifully well, rest your eyes on the NIH. The existence of this institution in its present form owes much to the political leaders, in and out of the Congress, whose wisdom and statecraft put it in place.”¹⁴

During the past 15 years, which were disastrous years for most domestic programs, the NIH has been relatively unscathed in comparison with many other federally funded programs. The Congress has always been an ardent supporter of medical research. There has never been a time since the inception of the NIH that the Congress has provided less funding for the NIH than was requested by the President.

Why have the increases for cancer research not been substantial over the past decade? At the present time, there is little institutional memory within the Congress regarding the importance of funding a “war” against cancer. We have relied for far too long on too few champions in the Congress, many of whom now are departed. A new generation of devoted legislators determined to contribute to the fight against cancer has not emerged. While many, many factors could be cited, the authors contend that one is of paramount importance: the need to provide increased funding for cancer research is not being presented persuasively, intensively, or passionately enough. As a result, no one is listening to the few individuals who have taken the case to the Congress. It is time for researchers, physicians, patients, families, and survivors to join together in greater numbers and in more active ways. It is time for those who deal with cancer in their daily lives to offer more persuasive arguments. They must convey the message that additional resources are vital, if our society is to address the full spectrum of these diseases. Legislators, and the general public, need to be persuaded that cancer research warrants strong support, and that such support is more than justified by the achievements of the past two decades.

A Call to Action

Each and every person involved in research has a responsibility to educate the community and its elected officials about the important benefits and goals of research. Recent articles in the scientific press have urged the research community to take its case to the policy makers and the general public and to broaden the base of support for research. The day is long gone when the research community can stay within the confines of the laboratory and expect that the resources will automatically be available to pursue crucial scientific quests. The responsibility goes beyond this. It is a moral imperative that health professionals involved in cancer care act as resources to elected officials in health policy development.

One of the classic examples of where the cancer community has failed to use its skill and expertise to alter public policy is with tobacco use. The “Year 2000 Goals” for the NCI have indicted tobacco use as the culprit responsible for approximately 35% of the incidence of cancer in the United States. And yet, public relations firms continue their advertising; in many states, children freely purchase tobacco and even smoke in schools; and the Bush Administration adopted trade policies facilitating tobacco exports to the developing nations that have continued under the Clinton Administration. What will be needed to persuade the cancer community to take its research data on the link between tobacco and cancer to legislators so as to influence and direct health policy in the area of tobacco? The ACS made a start when the 105th Congress considered comprehensive tobacco legislation; however, the research community was not an active player in this aspect of the debate.

The impetus for enacting the National Cancer Act was the desire of a diverse group of people, including scientists, philanthropists, legislators, and media representatives who had joined forces in a common cause, to call a halt to the further progression of cancer. Distinguished leaders worked hard and well to persuade the Congress that the National Cancer Act was good public policy. The people needed little persuasion.

The cancer community must learn from these precedents and carry on the legacy. It involves taking responsibility to educate the community and elected officials about the important benefit of cancer research. In doing so, it is advisable to develop both short- and long-term strategies to make a sustained and effective impact. A few questions: (1) What have you done to educate your local community, through radio, television, or speeches at local organizations, on the benefits of cancer research? (2) When did you last solicit the support of your patients, colleagues, and neighbors to gain the backing from elected officials for cancer research and affordable and accessible care? (3) When was the last time that your hospital, cancer center, or research laboratory held an open house for the press or the community, if ever? (4) Can you name your two senators and your representatives? When was the last time you met with them in Washington, or at home in your district? When did you last invite them to tour your research laboratory, patient unit, or medical facility? (5) When was the last time you wrote your legislators expressing concern on a specific issue, requesting their support, and providing the necessary follow-up to ensure a sustained commitment?

Epilogue

In 1971, momentum existed to make cancer research a national priority. Those involved had both a personal and professional commitment to the cause. Some had personal experiences with cancer prior to enacting the National Cancer Act; others lost loved ones or their own lives to cancer subsequent to its passage. Given that we are dealing with a group of diseases that will affect one in three Americans, any of us may similarly be emotionally, as well as intellectually, motivated to regenerate the legislative momentum to assure a vigorous program of cancer research and an efficient and humane program of cancer care. This is an agenda that is truly worthy of the United States and its citizens.

References

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