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Good morning, Senator Specter and members of the subcommittee. I am Richard Klausner, Director of the National Cancer Institute (NCI). We are here today to discuss the important issue of the unequal burden of cancer for ethnic minorities and the underserved. Let me state at the outset that this issue is one of great moment to the National Institutes of Health (NIH) and the NCI. Indeed, much of what we know about this problem is the result of the work of the NCI. In this, as in all aspects of our mission, there is much we still do not know and much more we can do. I want to extend my appreciation to Dr. Haynes and his committee for their report. It is a very thoughtful analysis, and we will look very carefully at all of their recommendations and discuss them, and their implementation, with our advisory bodies.

I can say unequivocally that we are making real progress against cancer. We measure progress in two ways: first, the increase in knowledge about cancer, and second, the reduction of the burden of this disease on people. I will tell you about progress in both our fundamental understanding of this disease and in our efforts to prevent it, find it as early as possible, and treat it. But first I want to say that progress made in both areas is already evident in the declining cancer incidence and death rates. Between 1990 and 1995, these rates dropped for all cancers combined and for most of the top 10 cancer sites, reversing a long-time trend of increasing cancer incidence and death rates in the United States.

After increasing 1.2 percent per year from 1973 to 1990, the incidence rate for all cancers combined declined an average of nearly 1 percent per year between 1990 and 1995. The rates declined for most age groups, for both men and women, and for most ethnic groups. The exceptions were black males, where the rates continued to increase, and Asian and Pacific Islander females, where the rates were level. The overall death rate declined an average of 0.5 percent a year from 1990 to 1995, with the declines greater for men than for women. The only ethnic group not included in the downturn was Asian and Pacific Islander females.

These decreases are good evidence of the power of this Nation's investment in cancer research and of the value of carefully conducted basic research, and clinical trials in a broad range of areas, including cancer control. We also realize that these declines, while encouraging, must be accelerated and extended so that all of our population benefits. The trends also show us that while some ethnic groups have higher incidence and mortality rates, others have lower rates, and we seek to better understand all of these variations.

Recent Advances in Understanding Cancer

As we understand the nature of cancer, we understand that it is a unique set of diseases, and that the answers to cancer are related to the most fundamental mysteries of life itself. We know that cancer is not one disease, but at least 100 different diseases that share certain features. Because of this, it is unlikely that one magic bullet will solve the problem.

The most remarkable progress in the past 25 years has been in our knowledge of cancer biology. We are dramatically extending our understanding of what is required to turn a normal cell into a cancer cell. Cancer arises when a single cell changes so that it divides continuously, released from the controls that constrain the replication of normal cells. This transformation results from changes in the function and activity of genes. Of the approximately 100,000 genes found in the human genome, the altered activities of only a relatively small number of genes are responsible for transforming a normal, well-behaved cell into a cancer cell. Identifying these cancer genes defines the central scientific hunt in cancer biology, and opens an unprecedented window into the nature of cancer. Up until now, our detection tools have lacked the sensitivity and the specificity that we must demand if early detection is to be useful and successful. Our interventions, despite their success, have, by and large, been the result of guesswork. But now, we are at a point where we can transform our approaches to cancer.

No one genetic alteration is enough to make a normal, healthy cell a cancer cell. Rather, an accumulation of changes in a relatively small number of genes during the lifetime of a cell is required. We have learned that some individuals carry a very high lifetime risk of developing cancer. This understanding has allowed us to begin describing the evolution of specific cancers from predisposition to pre-cancer to cancer. Each cancer is ultimately defined by its particular pattern of altered and normal gene activity. This unique pattern determines the cancer's rate of growth, tendency to spread, responsiveness to hormones and therapies, and also predicts the ability of a person's immune system to recognize and respond to the cancer. Moreover, cataloging these molecular patterns will ultimately tell us how many different cancers exist, and enable us to distinguish the differences between a cancer cell and a normal cell.

We also are learning to understand the causes of cancer. Research on cancer risk — the probability that the disease will occur in a given population — is identifying populations with a significant probability of developing cancer. Because cancer is a multistage process, analysis of risk factors leads to the development of prevention and control strategies, early detection methods, and in some cases more precise treatments. Epidemiologic research has identified many factors that increase cancer risk. Most of these are related to environment and lifestyle, while others are part of a person's genetic makeup. With the exception of a few genetic conditions, however, it is still not possible to predict with any degree of certainty that a person having one or more of these factors will develop cancer. This uncertainty is related to the very nature of cancer and the need for many specific alterations to accumulate in a single cell for that normal cell to be transformed into a cancer cell.

The Institute of Medicine Report

I take seriously my responsibility as Director of NCI to ensure that the research we carry out in our own laboratories and the research we support in facilities across the country benefits all Americans. Whether this means finding new ways to prevent cancer, improving patient access to clinical trials, or entering into new partnerships to more broadly disseminate information about advances in prevention or diagnosis or treatment, I have personally urged our staff to continuously strive to find new and better ways to accomplish our goals. We have made significant progress in many areas during my tenure as Director of NCI, but clearly this is an area where we need to do more.

NCI has three core responsibilities in addressing the issues raised by the Institute of Medicine (IOM) committee. First and foremost, we must conduct research that answers questions about the burden of cancer for all populations. Second, we must assure that individuals of diverse populations are represented in all aspects of our research enterprise: in population studies, clinical trials, and in the oversight and conduct of research. And third, we must communicate the results of our research and the opportunities to participate to a wide range of audiences, including patients, advocates, physicians, families, health professionals, Members of Congress, scientists, and the general public, in ways that are both valid and effective.

The report developed by the IOM presents a series of findings and recommendations for the NIH and NCI related to cancer in minority and underserved populations. As one might expect, there are some items on which we agree, and there are some areas where I strongly disagree with the recommendations presented. These are not simple problems, and there are no simple solutions. Many of the issues go well beyond the scope of a single Institute at NIH, and in some cases they have at their core some of the major social and public health challenges that face our entire Nation. While we need time to digest this report more fully, let me present three reactions to my initial study of it.

Areas of Agreement

I fully agree with many of the recommendations:

1. There is a critical need to improve our ability to address the needs of the underserved. This is true in all aspects of our health care delivery system, in many of our social services, and in research to improve our knowledge of the special needs of these individuals. We have addressed aspects of this question, but the report is correct: we need good, but flexible, definitions; and we need to focus more attention on documenting, understanding and disseminating knowledge gained about this very complex area.

As pointed out in the IOM Report much of "NCI's data collection efforts are shaped by Directive No. 15 of the U.S. OMB." Consistent with this mandate, the NCI has collected and reported data according to four basic "racial" categories (American Indian or Alaska Native, Asian or Pacific Islander, black or African American, or white), along with Hispanic ethnicity. The NCI Surveillance, Epidemiology and End Results (SEER) program collects information on country of origin of the cancer patient, which provides additional data on ethnicity.

The issue of monitoring and reporting on the racial and ethnic classifications, as called for in Office of Management and Budget (OMB) Directive 15, is important. These classifications are not scientifically sound, and do not reflect the variables important to the cancer burden. NCI has gone well beyond OMB 15 in attempting to monitor the burden of cancer, for example, by linking the SEER databases to other sources of information to evaluate socioeconomic status (SES) and to look at wider sets of macro-ethnic groups. However, the importance of linking data from disparate sources (the Census, Medicare, etc.) means that this issue cannot be solved by NCI in isolation. The NCI agrees that we should strive to develop and implement uniform definitions of ethnic minorities and medically underserved groups, whether it be through the use of ‘special populations' or other terms. Clear definitions of underserved populations are useful in categorizing and tracking research in this field and we are initiating more research in this area which extends current work. In particular, internal surveillance activity is focused on linkage of aggregate Census population data to SEER incidence and National Center for Health Statistics (NCHS) mortality data at the county level. Analyses are underway which develop alternative characterizations of geospatial cancer rates based on SES population attributes. Other developmental work is in progress which should lead to research initiatives from extramural investigators on the relationship of SES to cancer, guided in part by the recent publication by the International Agency for Research on Cancer (IARC) on social inequalities and cancer.

Cancer research must go beyond these OMB categories and SEER data, and, as I stated in my presentation to the IOM committee, there is no biologic basis for ‘race.' The NCI has acted on this understanding and for some time sought to collect data on specific ethnic groups beyond the OMB definitions, as evidenced by publications from the SEER program and the research initiatives it has supported. Thus, the task at hand is to develop the best measures of medically underserved to link to cancer outcomes (e.g., risk, incidence, morbidity, mortality, and survival).

The categorization of societally underserved people by their socioeconomic class, insurance status, or cultural background, is itself a subject for research. This is an area being pursued by NCI-sponsored investigator-initiated research, including some of our studies that focus on screening among underserved populations, as well as by initiatives from the Cancer Surveillance Research Program (CSRP) which address the measurement and monitoring of cancer rates based on SES indicators at the level of the individual and that person's neighborhood and community characteristics. In the fall of 1998, the SEER program hired a demographer with expertise in health data regarding racial/ethnic populations to help direct these efforts. Several new initiatives have been funded which enhance NCI's health services and economics research, particularly in regard to various managed care and other provider systems; e.g., the Cancer Research Network, the SEER-Medicare linked data base, and the Breast Cancer Surveillance Consortium.

2. We fully agree with the need to expand and enrich our surveillance programs and we are doing that , as the body of the IOM report documents. We are now awaiting the recommendation of a Surveillance Implementation Group we asked to address these complex questions.
3. We need to much more clearly articulate the planning and monitoring of our activities in these areas than we currently do.

I will state again that we will look very carefully at all of the recommendations and discuss their implementation with our advisory bodies.

Progress Has Been Made

The NCI, as pointed out in the report, has been very active in the past few years in addressing many of the issues raised. Following are examples of some of our efforts in selected areas that were addressed in the report.

1. SEER

Work is in progress to enhance the NCI CSRP and improve our capacity to measure the National cancer burden and our progress to reduce its impact on all Americans. The scope of the NCI surveillance enterprise covers a broad and complex range of data and data systems to measure the cancer burden. In addition to SEER's coverage of cancer incidence and survival for 14 percent of the U.S. population and significantly larger proportions of most racial/ethnic groups, the NCI utilizes and publishes reports based NCHS data on cancer mortality for the entire U.S. population. Specially-funded NCI surveys, cooperative group consortia, data linkage with national data bases, and supplements to federal health surveys are mechanisms we use to provide information on cancer risk, health behavior and health status, patterns of care and cancer outcomes, cost and quality of cancer care, and quality of life. Every surveillance research and analysis project includes an emphasis on information for different population groups. Selected examples are the recent 1998 SEER monograph on prostate cancer which includes a special chapter devoted to racial/ethnic patterns (available via the NCI web site), as well as the ongoing longitudinal SEER Prostate Cancer Outcomes Study which over-sampled black and Hispanic men.

The NCI recognizes the need to better explain the cancer burden in several high-risk ethnic minority and medically underserved populations and is concerned with research on the full diversity of the U.S. population. In 1975, 1979, 1983, and 1992, SEER has expanded to include populations critical to explaining the burden of cancer in this country. As noted in the IOM Report (page 40), these have included Hispanics, urban blacks and Asian and Pacific Islanders in Southern California and the South San Francisco Bay Area, rural African-Americans in Georgia, northwestern populations in Seattle, Arizona Indians, and Alaska Native Americans. One of the recommendations of the current Surveillance Implementation Group suggested in the NCI Cancer Control Review Group (again as noted by the IOM Report, page 40) is to further expand coverage to capture additional key populations, such as rural low-income whites, more diverse American Indian populations, rural African-Americans and other Hispanic groups. Beyond the SEER program, the CSRP is planning a coordinated co-funded effort with the NCHS and other NIH agencies, such as the National Heart, Lung, and Blood Institute to improve data collected on mortality by race/ethnicity.

2. Formulating new plans for training and career development

Several activities promote the availability of research training and career development opportunities at NCI. The NCI/Minority Access to Research Careers (MARC) Summer Training Program is designed to increase research training opportunities for underrepresented minority MARC scholars entering into cancer-related research careers. Through the Comprehensive Minority Biomedical Program of NCI, the American Association for Cancer Research (AACR) provides travel fellowships for minority students to attend annual meetings of the AACR; increases the attendance of minority scientists at the annual AACR meeting; and stimulates participation of predoctoral and postdoctoral minority students in cancer research. NCI invites academic health centers and other health professional schools that employ, educate, or serve a preponderance of minority faculty, staff, trainees, and communities to submit applications for support of activities directed at the development of faculty investigators at minority schools in areas relevant to cancer. National Research Service Awards, Individual Predoctoral Fellowships for Oncology Nurses, and Minority Students and Students with Disabilities Awards encourage nursing students, students with disabilities, and students from minority groups that are underrepresented in the biomedical and behavioral sciences to seek graduate degrees.

The Continuing Umbrella of Research Experience for Underrepresented Minorities Program (CURE) is a new strategy being implemented by the National Cancer Institute to expose minorities to cancer research at the high school and undergraduate levels. The program is being initiated nationwide and provides a "continuum of competitive opportunities" through the successful established independent cancer investigator. As part of the CURE initiative, NCI is collaborating with the National Science Foundation, the Office of Research on Minority Health, the National Center for Research Resources, the National Institute of General Medical Sciences, the National Institutes of Environmental Health Sciences and the Department of Defense on a nationwide minority training and career development program known as "The Bridge to the CURE." "The Bridge to the CURE" focuses on working with Minority Serving Institutions (historically Black Colleges and Universities, Hispanic-serving Institutions, and Tribal Colleges serving native Americans) to encourage minority participation in biomedical research. These institutions, while providing high quality education for minorities, typically lack the infrastructure and institutional commitment needed to conduct high quality biomedical research. This program aims to work with the institutions on developing the infrastructure and commitment to research and become full partners in the cancer research enterprise. The IOM committee was provided with information about this new, innovative program.

3. Setting goals for minority participation in clinical trials

The appropriate participation of ethnic/racial minority patients in clinical trials has been a specific goal of NCI. Indeed, there has been a considerable effort to provide wide access to clinical trials. Participation of diverse populations is desired out of a sense of social equity and because it may provide more valid and more generalizeable results. All NCI-supported clinical trials are reviewed to ensure that access to research protocols is equitable and that no arbitrary age-specific criteria are included in any of these studies. Older patients are generally eligible for all protocols unless specific medical contraindications exist. While accrual of minority patients is proportional to the population with cancer, accrual of the elderly has been lower than desired.

4. Behavior

Lifestyle and attitudes towards the health care system itself can directly and indirectly affect one's risk for cancer. Therefore, strategies to encourage change in behavior or attitudes in favor of healthier habits is an area currently under study by NCI, especially in regard to intervention research on tobacco use. NCI is conducting and sponsoring a number of programs and projects aimed at testing interventions that will motivate individuals to change their behavior with regard to smoking. Many of the studies target a specific culture or ethnic group, while others target youth with the idea that healthy habits should begin early and that children will teach their parents these healthy habits.

5. Survivorship

In agreement with the IOM Report we have recognized the need to enhance the collection and reporting of data on survival among ethnic minorities and medically underserved. SEER investigators and NCI staff are currently developing a new monograph on Cancer Survival for publication early next year. In addition, methodological and data quality issues related to estimating cancer survival for racial/ethnic groups are being addressed by NCI surveillance research staff. Publication of these data is in progress, which involves staff from the Office of Special Populations Research and a senior scientist from the extramural community. Furthermore, this topic has also been identified by the Surveillance Implementation Group as a priority and is one of the recognized aspects of expanding SEER to include additional populations. Non-SEER National Program of Cancer Registries (NPCR) states currently are required only to collect cancer incidence data. One mechanism to expand SEER would be to work with National American Association of Central Cancer Registries (NAACCR) non-SEER states that include high-risk populations of interest and who have demonstrated their ability to adhere to NAACCR's quality standards and to support the addition of survival data. Other approaches, such as facilitating data linkage of the non-SEER registry states with the NCHS National Death Index, are possible.

In the recent reorganization of the NCI, the Office of Cancer Survivorship (OCS) was formed within the Division Cancer Control and Population Science (DCCPS). The Office of Cancer Survivorship was established in 1996 to provide support and a focus for research and other activities dealing with cancer survivors. OCS workshops were held in 1996 and 1997 to define priorities for research, which included the prevalence of physical effects from cancer treatment, the prevalence of second cancers in survivors, quality of life, and quality and cost of follow-up care for survivors. In addition, this Office sponsored a national meeting last year on long-term survivors and will sponsor another this March 8-9, 1999 on Research Challenges and Opportunities for the New Millennium. A formal strategic plan for this Office awaits the imminent appointment of its Director in the next month or so.

6. Targeted Funding

NCI has several initiatives geared to specific groups in the community. These initiatives are intended to lead to more positive results in reducing the disproportionate burden of cancer that is apparent among various ethnic/racial groups. They include:

• Through Cancer Therapy Evaluation Program's (CTEP) Minority Initiative Program, five of the Cooperative Groups received a total of $1.1 million earmarked to foster minority accrual in F