[Senate Hearing 106-91]
[From the U.S. Government Publishing Office]


                                                         S. Hrg. 106-91


 
                    CANCER RESEARCH IN MINORITY AND
                   MEDICALLY UNDERSERVED POPULATIONS

=======================================================================

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                               __________

         Printed for the use of the Committee on Appropriations



                                


 Available via the World Wide Web: http://www.access.gpo.gov/congress/senate

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                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington             FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
JON KYL, Arizona
                   Steven J. Cortese, Staff Director
                 Lisa Sutherland, Deputy Staff Director
               James H. English, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
SLADE GORTON, Washington             ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire            DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho                   HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas          HERB KOHL, Wisconsin
TED STEVENS, Alaska                  PATTY MURRAY, Washington
JON KYL, Arizona                     DIANNE FEINSTEIN, California
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)
                           Professional Staff
                            Bettilou Taylor
                             Mary Dietrich
                              Jim Sourwine
                               Aura Dunn
                        Ellen Murray (Minority)

                         Administrative Support
                            Jennifer Stiefel
                       Carole Geagley (Minority)



                            C O N T E N T S

                              ----------                              
                                                                   Page
Statement of Dr. Richard D. Klausner, Director, National Cancer 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................     1
Statement of Dr. Otis W. Brawley, Assistant Director, Office of 
  Special Populations Research, Office of the Director, National 
  Cancer Institute, Department of Health and Human Services......     1
Statement of Dr. M. Alfred Haynes, chair, Institute of Medicine, 
  Committee on Cancer Research Among Minorities and the Medically 
  Underserved....................................................     1
Statement of Dr. Louis W. Sullivan, former Secretary of the U.S. 
  Department of Health and Human Services; president, Morehouse 
  School of Medicine.............................................     1
Statement of Armin D. Weinberg, Ph.D., cochair, Intercultural 
  Cancer Council, director, Center for Cancer Control Research, 
  Baylor College of Medicine.....................................     1
Opening remarks of Senator Specter...............................     1
Summary statement of Dr. M. Alfred Haynes........................     2
    Prepared statement...........................................     4
Summary statement of Dr. Richard D. Klausner.....................     5
Strategic planning...............................................     7
Prepared statement of Dr. Richard D. Klausner....................     8
Recent advances in understanding cancer..........................     8
Areas of agreement...............................................     9
Progress has been made...........................................    10
Areas of disagreement............................................    13
Segregation vs. integration......................................    13
Priority setting.................................................    14
Resource allocation..............................................    14
Strategic planning...............................................    14
Evaluation of information dissemination..........................    15
Cancer information service (CIS).................................    15
Physician data query (PDQ).......................................    16
Patient education activities.....................................    16
Consumer research and evaluation.................................    16
Seeking input for NCI activities.................................    17
Summary statement of Dr. Otis W. Brawley.........................    17
    Prepared statement...........................................    18
Ethnic minorities prone to certain cancers.......................    18
Summary statement of Dr. Louis W. Sullivan.......................    24
    Prepared statement...........................................    26
Summary statement of Armin D. Weinberg...........................    27
    Prepared statement...........................................    29
Lack of strategic plan...........................................    31
NCI accounting and spending discrepancies........................    31
Insufficient NCI spending........................................    31
NCI lacks necessary database.....................................    31
Defining ethnicity and race......................................    32
Changing the NIH culture: Research training......................    32
Adequate funding.................................................    33



   CANCER RESEARCH IN MINORITY AND MEDICALLY UNDERSERVED POPULATIONS

                              ----------                              


                       THURSDAY, JANUARY 21, 1999

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:30 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter and Stevens.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENTS OF:
        DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
        DR. OTIS W. BRAWLEY, ASSISTANT DIRECTOR, OFFICE OF SPECIAL 
            POPULATIONS RESEARCH, OFFICE OF THE DIRECTOR, NATIONAL 
            CANCER INSTITUTE

                       NONDEPARTMENTAL WITNESSES

STATEMENTS OF:
        DR. M. ALFRED HAYNES, CHAIR, INSTITUTE OF MEDICINE, COMMITTEE 
            ON CANCER RESEARCH AMONG MINORITIES AND THE MEDICALLY 
            UNDERSERVED
        DR. LOUIS W. SULLIVAN, FORMER SECRETARY OF THE U.S. DEPARTMENT 
            OF HEALTH AND HUMAN SERVICES; PRESIDENT, MOREHOUSE SCHOOL 
            OF MEDICINE
        ARMIN D. WEINBERG, Ph.D., COCHAIR, INTERCULTURAL CANCER 
            COUNCIL, DIRECTOR, CENTER FOR CANCER CONTROL RESEARCH, 
            BAYLOR COLLEGE OF MEDICINE

                   opening remarks of senator specter

    Senator Specter. Good morning, ladies and gentlemen. The 
hour of 9:30 a.m., having arrived, the Appropriations 
Subcommittee on Labor, Health and Human Services, and 
Education, will now proceed.
    We will hear this morning testimony on the Institute of 
Medicine study on cancer research on minorities and the 
medically underserved for fiscal year 1997. This subcommittee 
requested the Institute of Medicine to conduct a review of the 
status of research into cancer among minorities and the 
medically underserved. That was formulated in September 1996 
for fiscal year 1997.
    We then expressed our concern in July 1997 questioning why 
it took some 9 months for the study to get under way, and then 
a contract was awarded in August 1997.
    I mention that history very briefly to underscore the 
importance of prompt progress when the Congress, which adopted 
the recommendation of the subcommittee that this study be 
undertaken, that we really have to do it on an expedited basis.
    My own sense is that every day we lose on making judgments 
on health care, it costs lives. We just went through the stem 
cell issue, which is a graphic illustration but I think it 
applies across the board. We really have to approach these 
health issues with a sense of urgency.
    The scientific understanding of cancer control, prevention, 
detection, and treatment has improved dramatically in recent 
years, leading to 1998 being the first overall decline in the 
cancer mortality rate in the United States. And despite these 
scientific gains, however, not all segments of the United 
States population have benefitted to the fullest extent from 
the advances.
    The Institute of Medicine found quite a number of problems 
with at least their contention on the National Institute of 
Health in the study and the National Cancer Institute, and we 
are here today to examine those and to hear the responses of 
the National Cancer Institute.
    At 8:45 o'clock this morning, I was advised that the 
Republican Caucus had been set for 10 a.m., which looked 
impossible, but then was postponed till 10:30. So, we are going 
to be under a very tight time constraint today to conclude the 
hearing within 1 hour. Our customary allocation is to ask the 
witnesses to speak for 5 minutes, with the full statements 
being admitted to the record, and we will maintain that, but we 
would like to have you observe that time limit.
    For expediting purposes, I am going to call on the first 
two panels together: Dr. Alfred Haynes, chair of the Institute 
of Medicine [IOM], Committee on Cancer Research Among 
Minorities and the Medically Underserved; Dr. Richard Klausner, 
Director of the National Cancer Institute; and Dr. Otis 
Brawley, assistant director of the Office of Special Population 
Research. A very distinguished panel.
    Gentlemen, we thank you very much for joining us, and we 
will open with you, Dr. Haynes.


                 summary statement of dr. alfred haynes


    Dr. Haynes. Good morning again, Senator Specter.
    On behalf of the 15 members of the IOM committee, I am here 
today to present our report.
    In accordance with your request to limit my testimony to 5 
minutes, I have submitted full testimony in electronic form. I 
will, therefore, limit my remarks to a few of the most critical 
recommendations of the report.
    This study was fully supported by NIH and received the full 
cooperation of the National Cancer Institute.
    There is dynamic progress, dynamic change at NCI, and there 
was full agreement with some of our recommendations, partial 
agreement with others, and honest disagreement with a few.
    There was full agreement with our recommendations to expand 
the SEER program to collect cancer information for groups not 
currently covered, including the medically underserved.
    There was agreement with the recommendation to move towards 
a national registry for relating the work of the SEER program 
and the work of several State registries. That is assisted by 
the Centers of Disease Control and Prevention.
    There was also agreement that a shift from an emphasis on 
racial classifications to ethnic groups would be more useful to 
cancer research. The committee commended the National Cancer 
Institute for its expanded program of behavioral research. That 
area has been too long neglected.
    There was only partial agreement on our analysis of the 
institute's allocation of resources to research on minorities 
and the medically underserved. We disagree with the method of 
analysis by which the institute accounts for the second 
category which is based on the percentage of minorities 
involved in a research study. This method of analysis actually 
triggers criticism that the allocation is inadequate, with 
which the National Cancer Institute disagrees. But they do 
agree with our view that it would be better to account for 
minorities on the basis of whether or not the study is designed 
to answer questions pertinent to the problem of cancer in 
minority groups.
    There is also partial disagreement about our assessment of 
priority setting. We agree with the view that scientific 
opportunity should have a high priority, but we argue that 
research opportunity must be taken in conjunction with the 
burden of cancer. If this is indeed the position of the 
institute, there has been a problem of communication because no 
member of the committee understood it to be so.
    There was honest disagreement with a few of our views about 
planning. When we report that there was no evidence of a plan, 
it implies that the plan, if it existed, was not obvious to us. 
It is entirely possible that enough time had not elapsed for 
the design of the plan to be transparent.

                           prepared statement

    Finally, there is one point on which we can all agree. The 
complexity of the problem of cancer is often misunderstood. 
Cancer is not a single disease. It is more than 100 diseases. 
This institute is important to all Americans and deserves our 
generous support so that it can meet the needs of all segments 
of our increasingly diverse population.
    I will be happy to answer any questions.
    Senator Specter. Well, thank you very much, Dr. Haynes, and 
thank you for undertaking the chairmanship of the Institute of 
Medicine Committee on Cancer Research among Minorities. You 
have brought to that position a very distinguished record: 
epidemiologist, former President and Dean of Drew Postgraduate 
Medical School, and former Director of Drew-Meharry-Morehouse 
Consortium Cancer Center. So, we thank you for your comments.
    [The statement follows:]

                 Prepared Statement of M. Alfred Haynes

    Good morning Senator Specter and members of the 
Subcommittee. On behalf of the entire committee I am pleased to 
be here today to present our report.
    One in four deaths in this country is attributable to 
cancer, which is expected to become the country's leading 
killer in the next century. Recent scientific gains have fueled 
the first overall reduction in deaths from cancer, but not all 
groups in the U.S. population have seen an improvement. Poor 
people and some ethnic minorities are more prone to certain 
types of cancer, and less likely to survive it, than are the 
rest of the population.
    African-American men, for example, are more likely to be 
diagnosed with prostate cancer than white men. Asian Americans 
are more likely to develop stomach and liver cancer. Cervical 
cancer is higher among Hispanic- and Vietnamese-American women. 
African-American women, though less likely than others to 
develop breast cancer, are also less likely to survive it. 
Further, lower-income whites in rural areas such as Appalachia 
have some of the highest rates of specific types of cancer in 
the country. And Native Americans have the lowest cancer 
survival rates of all.
    A key question for researchers and public health officials 
is why these differences in cancer and survival rates persist.
    The 15-member Institute of Medicine committee that I 
chaired examined these questions, and looked at how the 
National Institutes of Health (NIH) approaches cancer research 
among minorities and the medically underserved. We examined how 
NIH prioritizes minority cancer research and how it applies 
research findings to prevention and treatment programs. We also 
looked at the adequacy of procedures related to including 
minorities in clinical trials, the communication of research 
results, and other key issues. Today we offer recommendations 
that we hope not only will help improve the health of 
minorities and the medically underserved, but everyone in our 
increasingly diverse society.
    A critical first step is being able to pinpoint exactly 
what differences exist among ethnic groups and others. By 
legislation, the National Cancer Institute's Surveillance, 
Epidemiology, and End Results program--or SEER--is assigned the 
responsibility of assessing the burden of cancer in the 
population by continuously monitoring cancer incidence, 
mortality, and survival rates. It is the closest thing the 
country has to a longitudinal national cancer database, but 
limitations in the way data are collected have limited its 
usefulness.
    Unfortunately, several key groups, such as many non-Mexican 
Hispanics, are not adequately covered in the SEER program. In 
order for this program to be most effective, it should be 
expanded to include these and other members of the population 
not now covered. These populations also include lower-income or 
poverty level whites, especially those living in rural areas. 
Further, this database should be coordinated with newer state 
databases to create a national registry with uniform methods of 
data collection and analysis.
    In accordance with the guidelines of the federal Office of 
Management and Budget, the National Cancer Institute (NCI) 
classifies the population into one of four racial categories--
White, Black, Asian or Pacific Islander, or Native American. 
This method of classification was not intended for 
epidemiological research and, in fact, is not consistent with 
current scientific thinking. There are no known biological 
boundaries that justify the division into races.
    We recommend that NCI place a greater emphasis on the 
differences in cancer among ethnic groups, with a view to 
determining the roles that diet, lifestyle, and customs play in 
varying rates of cancer. We need to take advantage of the 
ethnic diversity of the American population to explore, for 
example, why Chinese American men have such low rates of 
prostate cancer compared with African American men.
    Overall, we believe that NIH needs to formulate a blueprint 
or a coordinated plan for addressing questions related to 
cancer among minorities and the medically underserved. NIH's 
Office of Research on Minority Health coordinates studies on 
ethnic minority health problems, but its impact is limited by 
the size of its budget and other constraints. That office 
should more actively coordinate, plan, and facilitate cancer 
research across NIH centers and institutes. Within the National 
Cancer Institute, the Office of Special Populations Research 
lacks the authority and resources to coordinate an extensive 
program of research on cancer among ethnic minorities. This 
office should be given greater authority to expand NCI's 
research in these areas.
    NCI also should improve its estimates of the money it 
spends on the health needs of minorities and the medically 
underserved. NCI reported spending about $124 million in fiscal 
year 1997 for research and training programs addressing cancer 
in these populations, but we believe the true figure is closer 
to $24 million--or about 1 percent of NCI's budget. NCI's 
estimate is derived by calculating the percentage of minorities 
enrolled in research studies. Our estimate is based on the 
number of funded projects that are focused specifically on 
minority health issues. We believe that NCI should base its 
estimate on the research question involved rather than on the 
percentage of minorities in its studies. When one considers the 
greater burden of cancer among minorities and the increasing 
diversity of the U.S. population, NCI's current allocation is 
too low.
    In setting research priorities, NCI places strong emphasis 
on research that capitalizes on scientific opportunities, and 
rightly so. However, we believe that NCI should give 
consideration to the magnitude of the cancer problem in 
different ethnic groups. The diversity of the American 
population offers a great opportunity for exploring all of the 
possible causes of cancer.
    Participation in clinical trials among minorities has 
improved in recent years, to the point where their 
participation in NCI-sponsored cancer treatment trials is 
proportionate to the burden of disease in these populations. 
However, participation in prevention trials remains low. The 
absence of minorities in some of these trials--for example the 
recently concluded tests of tamoxifen to prevent breast cancer 
in women at high risk for the disease--raises questions about 
how applicable the results are to minority populations.
    As NIH and NCI continue to review strategies for 
communicating with the public, they should give special 
attention to the needs of ethnically diverse and medically 
underserved communities. Among the key issues that remain is 
how to obtain truly informed consent from research subjects who 
experience language and literacy barriers.
    NIH should establish a formal system of reporting to 
Congress and the public on cancer studies for ethnic minorities 
and medically underserved groups. Reports should include 
details on the number and type of research programs 
specifically targeted to these groups, and the contributions of 
ethnic minority scientists and community groups to the research 
priority-setting process. At the same time, NCI should improve 
efforts to disseminate information about cancer to patients, 
clinicians, and others in ethnic minority and underserved 
populations, and create a system to assess effectiveness. 
Cancer survivors in ethnic minority groups should be tapped as 
important resources for educating others in their communities 
about cancer.
    We encourage reporting in a variety of styles, including 
one based on what might happen if all Americans had the same 
rate of cancer at each site as the lowest rate of any ethnic 
group. For example, if all Americans had the low rate of lung 
cancer as Hispanics, and the low rate of cervical cancer as the 
white population, etc., the mortality from cancer would be 
reduced by 50 percent. It is a goal worth pursuing as long as 
there were not promises of quick results.
    Throughout our study, the National Cancer Institute was 
generous in providing the information that we requested, and it 
is clear to us that NCI is undergoing dynamic change. In fact, 
some of our suggestions for improvement today have already been 
suggested internally at NCI and are in the process of being 
implemented. We commend NCI's plans to increase its commitment 
to behavioral research, especially if some of that research is 
specifically targeted toward minorities and the medically 
underserved.
    The National Cancer Institute is a great national resource 
that is vigorously pursuing the goal of reducing cancer in 
America. From the beginning of the ``War on Cancer'' it has 
been forced to grapple with the continuous demand for quick 
results. There was even a strong notion that the problem of 
cancer would be solved by 1976. But we now know that there are 
no quick fixes in cancer research. A big breakthrough is often 
the result of years of patient and sometimes unrecognized 
effort. Cancer is not one but more than 100 diseases. We hope 
our recommendations will help NCI and all of NIH tackle this 
difficult health problem in order to further the health of all 
Americans.
    We are happy to answer your questions. Prior to asking a 
question, please step to an aisle microphone and state your 
name and affiliation.


               summary statement of dr. richard klausner


    Senator Specter. We turn now to the very distinguished 
Director of the National Cancer Institute, Dr. Richard 
Klausner. Undergraduate degree from Yale, medical degree from 
Duke, author of some 280 scientific articles and books. We 
welcome you here again, Dr. Klausner, and look forward to your 
testimony.
    Dr. Klausner. Thank you. Good morning, Senator Specter.
    Let me state at the outset that the issue of the unequal 
burden of cancer is one of great moment for the NIH and the 
NCI, and to point out that much of what we do know about this 
question is the result of the work of the NCI. In this, as in 
all aspects of what we do, there is much we still do not know 
and much more we can do.
    And I want to extend my appreciation to Dr. Haynes and his 
committee for their report. We will look very carefully at all 
of their recommendations and discuss them and their 
implementation within the institute and with our advisory 
bodies.
    While we must digest this report more thoroughly, I do 
fully agree with many of the critical recommendations. Let me 
just briefly state those.
    We agree with the need to better address the burden of 
cancer in the underserved. For years the NCI has studied 
aspects of this question. The report is correct. We need to 
develop good, but flexible definitions of what it means to be 
medically underserved and we need to focus more attention on 
the impact of being underserved on the burden of cancer.
    Second, we do utilize the racial and ethnic classifications 
as mandated by OMB directive 15 for monitoring and reporting. 
We agree with the committee that these classifications are 
neither scientifically sound nor reflect the variables 
important to the cancer burden. NCI has traditionally gone well 
beyond OMB 15 and we now regularly report the burden of cancer 
among many macro-ethnic groups. We have linked the SEER 
database to other databases to look at the relationship between 
socioeconomic status, educational levels, and the cancer 
burden, but there's more we need to do.
    It should be noted, however, in terms of classification, 
that the critical importance of linking our databases with 
other databases, the Census, Medicare, State databases, in 
order to address the questions that the committee correctly 
raises, means that the issue of classification cannot be solved 
by NCI in isolation. We need to work together about this.
    We fully agree with the need to expand and enrich our 
surveillance programs to give a more complete picture of cancer 
patterns and trends, and this is underway.
    Let me just state, because of the limited time, that we 
appreciate the committee's recognizing that we are a work in 
progress and there are many things that have been undertaken 
over the last few years to address many of the issues, and 
perhaps we can go through that in the question period.
    Let me actually get to the point of our disagreement, and 
that is about planning and accounting principles in the report. 
This is important, and I am sure Dr. Haynes is right: We need 
to do a much better job at being clear and articulate in our 
communication.
    The critical issue of different burdens of cancer and 
different experiences of cancer in minorities and the 
underserved must be, I believe, pervasive throughout all of our 
areas of research, and that's a guiding principle we use. We 
want as many of our studies as possible to include addressing 
real issues of the impact of social, cultural, linguistic, and 
economic and genetic factors in cancer.
    When a large or multi-faceted study directly addresses the 
unequal burden of cancer, we code a fraction of the total 
research project costs as directed towards minority and 
underserved research. If, on the other hand, we only counted 
dollars for projects that solely addressed questions of unequal 
burden, we would then need a parallel research structure, 
segregated from the researchers, projects, programs, and 
infrastructures we support for all cancer. I believe this is 
impractical. It is inefficient and counterproductive. It would, 
in fact, result in our failure to answer many of the questions 
posed by the IOM, and I can illustrate that, if you would like, 
with an example perhaps afterward.


                           strategic planning


    Our approach to strategic planning is to address the 
unequal burden of cancer within our planning for each component 
of the NCI. Here is one example. Our Office of Cancer 
Communications plays a vital role in the dissemination of 
cancer research information and results to minority and 
underserved populations. The NCI integrates communications to 
minorities and underserved populations within each overall 
effort. Printed and audiovisual materials that are easy to 
read, culturally appropriate, and translated into Spanish are 
disseminated through the Cancer Information Service, through 
direct mailings to minority advocacy groups and partners, 
through minority media outlets, and through national and State 
regional and community-based health providers.
    One of the three goals of the Cancer Information Service is 
to provide cancer information to those who do not use the 
telephone to gather information, primarily minorities and 
underserved audiences. We do this through formal partnerships 
with over 4,500 organizations. Two-thirds of these focus on 
reaching minority audiences. In the next year, the Cancer 
Information Service will require that 80 percent of those 
contacts initiated will be with partners that work with 
minority and medically underserved populations.
    This is the type of example of incorporating specific 
strategic plans, not as a global strategic plan as I understand 
the IOM recommendation. We do this for each of our areas: 
training, surveillance, general research, clinical trials, et 
cetera. That is how we do our strategic planning.
    There are many other issues raised by the report which I 
hope we have time to discuss.
    And let me just close by thanking you for your interest in 
what we all agree is an important issues. The NCI has and will 
continue to address the unequal burden of cancer and will 
attempt to act on the many excellent recommendations.

                           prepared statement

    It is important to remember, however, that the root of the 
unequal burden of cancer is in part a reflection of unequal 
resources, access, power, and opportunities in our society. I 
say this not to shirk NCI's responsibilities, but to reinforce 
the committee's position that NCI alone as a research 
institution will not erase the unequal burden of cancer unless 
we as a society are committed to addressing the fact that too 
many of our people have inadequate access to health care.
    I thank you for your attention and I look forward to 
answering questions.
    Senator Specter. Thank you very much, Dr. Klausner.
    [The statement follows:]
                 Prepared Statement of Richard Klausner
    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.
    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.
    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.
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.
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.
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.
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.
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.
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 
        Fiscal Year 1997. These funds have paid for focus groups and 
        educational opportunities for minority professionals, 
        advertising to increase minority awareness of clinical trials, 
        as well as data management, translators, and community outreach 
        in institutions with high minority patient populations.
  --The National Institute on Aging (NIA) and CTEP have co-sponsored 
        two studies, one in ovarian cancer and one in breast cancer, to 
        determine factors that present the greatest barrier to the 
        participation of older patients in clinical trials.
  --Minority Biomedical Research Support (MBRS) grants co-funded by the 
        National Institute of General Medical Sciences and NCI provide 
        expanded opportunities for ethnic minority faculty and students 
        at minority institutions to participate in biomedical research 
        through institutional grants.
  --The Leadership Initiatives on Cancer (Black, Hispanic, Appalachia 
        region targeting the underserved) address the cancer-related 
        needs within these communities through the establishment of 
        coalitions; stimulate the involvement of community leaders; and 
        develop and support intervention and outreach activities in 
        these communities throughout the United States and Puerto Rico.
  --Through its 19 regional offices, covering all 50 states and Puerto 
        Rico, the Cancer Information Service (CIS) supports programs 
        according to the specific needs of each region's special 
        populations. The successful CIS collaboration with outreach 
        partners to reach minorities and underserved populations has 
        focused on program planning assistance, increasing breast and 
        cervical cancer screening for women 50 and over, and assuring 
        community access to the latest, most accurate cancer 
        information.
                         areas of disagreement
    Although we agree in many areas, the NCI and the IOM differ in our 
views of the best and most appropriate way to attain very similar goals 
for research into the unequal burden of cancer. We have clearly stated 
and written in our planning documents that the pervasive issue of 
different burdens and different experiences of cancer in minorities and 
the underserved must likewise be pervasive throughout all areas of our 
research. We have acted to assure that we ask questions about unequal 
cancer burden for surveillance, epidemiology, prevention, detection, 
treatment, survivorship, training, and communication.
    We want as many of our studies as possible to address real 
questions of the impact of social, cultural, linguistic, economic, and 
genetic factors in cancer. When a large or multifaceted study directly 
addresses the unequal burden of cancer, we code a fraction of the total 
research project costs as directed at minority and underserved 
research. If we only count dollars for projects that solely address 
questions of unequal burden, we will need to create a parallel research 
structure, segregated from the researchers, projects, programs and 
infrastructures we support for all cancer research. This is impractical 
and inefficient and will fail to answer many of the questions posed by 
the IOM report. Let me illustrate: The Prostate Cancer Outcome Study is 
a large community-based effort to provide new information about the 
reasons for variations in prostate cancer diagnostic and treatment 
practice patterns among varying populations. It is allowing us to ask 
many important questions about the detection, diagnosis, and treatment 
of prostate cancer. Some of these questions include whether various 
racial and ethnic minorities experience systematic differences. This is 
an example of a project that we code as including 10-20 percent of the 
funds directed towards answering questions about the unequal burden of 
cancer. It is the coding of such clearly relevant research that the IOM 
committee rejects.
    The IOM committee reasonably raises concerns about coding fractions 
of studies and issues such as minority participation in clinical trials 
and other studies. We will re-examine our coding, but I do not agree 
that we should only code dollars for projects that only address issues 
of the unequal burden of cancer regardless of whether the larger 
projects are utilizing funds to directly, but not solely, address the 
issues outlined in the report. This would, in fact, exclude many of the 
studies that have given rise to publications that specifically address 
minority and underserved populations. In data provided to the IOM 
committee, we compiled a list of over 740 publications over the past 10 
years specifically addressing minority populations arising from NCI 
funded research. Of those, 81 percent were from studies that were not 
focused solely on minorities.
                      segregation vs. integration
    NCI firmly believes that research on the cancer burden of ethnic 
minorities and medically underserved populations must to the extent 
possible be woven into the full fabric of our research. There are times 
when studies should be and are within subgroups. But to segregate 
research this way would isolate the data we obtain; limit our ability 
to compare with the full population; and restrict our discovery of 
trends within subgroups that may only be discerned across the general 
population. There are very real statistical difficulties when study 
participation is small, so general population studies greatly improve 
our ability to decipher results across the various groups, so that all 
groups benefit from the knowledge we gain. In these large 
investigations, questions relevant to minority and other subgroup 
populations are encouraged and supported. Finally, integrated research 
provides efficient use of resources and higher quality of study design, 
as compared with conducting the same study for each subgroup. Larger, 
integrated research studies also have the benefit that compliance 
problems, which can be crippling in some studies, are not as critical 
to the study's outcome.
                            priority setting
    Setting NCI's funding priorities is a complex and dynamic process 
driven by several principles. We recognize that we must support the 
full range of research activities necessary to confront cancer; 
therefore, we strive for a ``balanced'' portfolio of research. This 
balance must include attention to all of the distinct diseases we 
collectively refer to as cancer, and to all of the various populations 
that experience these diseases differently. NCI places a high value on 
the incorporation of scientific questions relevant to ethnic minority 
and medically underserved populations in the full spectrum of our 
research.
                          resource allocation
    In 1997, NCI spent an estimated $124,399,000 on minority research 
programs. Estimation of funding varies between clinical trials and 
investigator initiated research projects. Minority groups are 
proportionally represented in clinical trials and funding is estimated 
according to the accrual of the study population by racial/ethnic 
groups. This method may not always equate to a proportional benefit for 
the larger minority population from which the trial participants were 
drawn but has the benefit of being consistent across time periods and 
provides a measure that is comparable with other per capita measures of 
clinical trials. Investigator initiated research projects estimate 
funding according to each individual project's relevancy to minority 
health as determined by the project director and the Office of Special 
Populations Research. Although this method is highly susceptible to 
variability, it is felt to be a conservative measurement of NCI funding 
for minority health research because minority populations participate 
in many projects that are not considered minority research but require 
minority participation due to NIH requirements for racial/ethnic 
diversity.
                           strategic planning
    Contrary to the implication in the IOM report that NCI does not 
engage in strategic planning, I can state unequivocally that we have a 
very active, dynamic, and visionary planning process. The IOM committee 
was provided with copies of a document entitled ``Priority Setting at 
the National Cancer Institute: A Summary Report Updated February 1998'' 
which contains a detailed description of NCI's strategic planning 
process, as well as with copies of other documents relevant to planning 
such as reports from various groups reviewing NCI's major programs. We 
involve a very broad constituency of advisors, advocates, researchers, 
and practitioners in developing our plans. Further, the Bypass Budget 
serves as a two-year strategic plan, describing the areas of scientific 
advancement we believe merit funding to enhance research, training, and 
communications programs. It serves as our central planning document, 
laying out clearly our funding priorities. It represents the investment 
needed to take the next crucial steps toward the day when cancer is no 
longer a burden. We also do in-depth strategic planning in specific 
areas. For example, we recently completed development of our Tobacco 
Research Implementation Plan and the development of a Surveillance 
Implementation Plan is in progress.
    NCI has a long history of making frequent use of extramural experts 
and advisors to determine its forward motion. There have, in fact, been 
three comprehensive reviews in the last two years that have recommended 
strategic initiatives relevant to research among ethnic minority and 
medically underserved populations. Recommendations from these groups 
have generated the creation of strategic implementation groups at NCI 
which have outlined strategies that are being followed in all of our 
programs.
    Thus we have a different approach to strategic planning than 
envisioned by the IOM committee. Contrary to its assertion that because 
we explicitly plan for the issues of the unequal burden of cancer 
within the context of our overall planning, there is therefore no 
planning, we believe that our approach is a valid, honest and effective 
alternative to the approach it is calling for.
       the role of the nci office of special populations research
    The Office of Special Populations Research advises the Director of 
NCI and serves as a focal point to provide leadership and coordination 
on research related to America's special populations. The Office 
coordinates NCI programs addressing scientific questions pertinent to 
minority and ethnic populations as well as the elderly, the medically 
underserved, rural and low-income groups. The Office works closely with 
other NIH Offices interested in the health and welfare of special 
populations. The expertise of individuals, scientific and lay, from the 
community is also being sought through the establishment of an NCI 
Special Populations Liaison Working Group. This Office has also 
recently completed a summary report on research and program activities 
related to minorities and the underserved titled ``NCI Initiatives for 
Special Populations 1998'' which will be available the week of January 
25, 1999 on the NCI website.
                evaluation of information dissemination
    The NCI plays a vital role in the dissemination of cancer research 
information/results to minority and underserved populations. 
Communications are carefully and strategically planned to achieve the 
following goals: dissemination of new research information for cancer 
prevention, screening, detection, and treatment to minority and 
medically underserved populations, health care providers, federal 
agencies, and the general public; and coordination of cross 
programmatic areas with other agencies (i.e., Centers for Disease 
Control and Prevention), while addressing concerns such as targeting 
low-literacy populations.
    NCI achieves these goals through strategic communications planning, 
and integrates communications to minority and underserved populations 
within each of its overall efforts. NCI targets its audiences, uses 
appropriate dissemination channels for each audience, develops and 
disseminates appropriate messages and materials through mass media 
campaigns, and through partnerships with other federal and non-
governmental agencies and organizations that have special access to the 
target audiences.
    The NCI develops media and print materials designed for 
distribution to a variety of audiences to achieve objectives/goals set 
forth in the strategic plan. Some of these collateral materials are 
designed specially for minorities and the medically underserved and are 
often implemented as part of national campaigns. These materials 
support the main message of a campaign (for example, women over age 40 
should have regular mammograms) but are designed to be used by 
community leaders to target populations including African Americans, 
Hispanics, Asians, and Native Americans.
    Other collateral materials for minority populations include posters 
in English for African-American, Asian, and Native American women, and 
in Spanish, Vietnamese, Chinese, and Korean that encourage women to 
have mammograms. In addition, NCI developed a Pap test video for Native 
Americans, radio and television public service announcements 
encouraging African-American women to have mammograms, English and 
Spanish print public service announcements promoting good nutrition. 
NCI also contributed to a nationally syndicated Spanish radio show, 
hosted by Elmer Huerta, promoting breast and cervical cancer prevention 
and detection.
    Printed and audiovisual materials that are easy-to-read, culturally 
appropriate or in Spanish are disseminated through the Cancer 
Information Service outreach program, through direct mailings to 
minority advocacy groups and partners, through minority media, and 
through national, state, and regional community-based health providers, 
cancer prevention experts, and health care professionals. Special media 
promotions are also conducted. One example is the effort to increase 
awareness about clinical trials by placing stories in the minority 
media. More recently, we have funded a number of investigators who are 
developing tailored health communications. Some of these investigators 
have designed materials tailored to specific variables, including 
ethnicity, income, and gender. Research shows that tailored materials 
used in a community health center dramatically increased smoking 
cessation among poor African Americans; decreased fat intake in a 
diverse population; increased mammography among African American women 
with incomes below $26,000; and increased fruit and vegetable 
consumption among rural African Americans who participated in a church-
based project.
                    cancer information service (cis)
    The CIS program has three interrelated components: (1) telephone 
service; (2) outreach aimed at providing cancer information to those 
who do not use the telephone to gather information (primarily 
minorities and other underserved audiences); and (3) cancer control 
research.
    The CIS Outreach Program develops partnerships with nonprofit, 
private, and Government agencies, mostly at the local and regional 
levels. These local and regional partners have an established presence 
in their regions, are trusted within their communities, and are 
dedicated to serving minority and underserved populations.
    Outreach staff respond to 100,000 requests by 4,500 organizations 
annually. Two-thirds of these CIS partners focus on reaching minority 
audiences.
    More than three-quarters of CIS partners strive to reach medically 
underserved audiences.
    In a 1996 survey of CIS partner organizations, over 90 percent 
rated the service provided by CIS to be important to meeting the goals 
of their projects.
    In the next year, CIS will require that 80 percent of all contacts 
initiated by Outreach staff be with partners that work with minority 
and medically underserved populations.
    The CIS is in the process of developing a comprehensive outreach 
evaluation plan which will better measure the impact of our efforts 
with partners serving diverse communities.
    Through the CIS, we have tested new ways to encourage African 
Americans to call the CIS for help to quit smoking. These methods have 
included targeted radio outreach and have been effective.
                       physician data query (pdq)
    Patients and health care professionals want and need access to 
accurate, up to date, comprehensive information about ongoing clinical 
trials. Through PDQ, NCI provides information about NCI-sponsored 
trials. PDQ presents information in both English and Spanish. It can be 
reached via a computer or fax machine. Information about clinical 
trials is also available through the CIS.
    We are in the process of expanding the database, with the 
cooperation of patient advocates, the Food and Drug Administration 
(FDA), and the pharmaceutical industry, to include all cancer clinical 
trials approved by the FDA and to revamp the way information is 
presented. This system has served as a model for other institutes at 
the National Institutes of Health, and we want to ensure that it 
continues to be responsive to the needs of all of the communities we 
serve.
                      patient education activities
    The National Cancer Institute's patient education programs are 
designed to enable cancer patients to make informed decisions about 
cancer care, deal effectively with cancer treatment, side effects, and 
recurrence, and adjust to a life with cancer. Because the medically 
underserved and minority populations must overcome both socioeconomic 
and cultural barriers to cancer information and treatment, as well as 
higher incidence rates, and often have more advanced disease at the 
time of diagnosis, special efforts have been made to ensure that the 
educational and informational needs of these groups are addressed by 
NCI's patient education programs.
    Examples include:
    Development of print and electronic informational resources for 
non-English speaking audiences, as well as groups with low literacy 
ability. Several of NCI's core patient education resources are 
available in Spanish, and plans are in development to produce 
Chemotherapy and You and Radiation Therapy and You in ten languages.
    Testing and conduct of training for health professionals. A new NCI 
training program for health professionals, The Cancer Clinical Trials 
Education Program, was pilot tested with numerous minority audiences, 
and their input and feedback ensured that the program would meet the 
varied cultural, economic, and educational needs of diverse groups, 
including the suggestion and execution of slides for Asian-American, 
Hispanic, and African-American audiences. Involvement of these partners 
in the development of the program has resulted in programs that support 
the NCI's interest in increasing population diversity in clinical 
trials participation.
    The Cancer Journey: Issues for Survivors, a training program for 
health professionals, includes a thirty-minute videotape of cancer 
survivors discussing the range of issues they faced from the time of 
their diagnosis through treatment and follow-up care. The videotape 
includes an ethnically diverse group of patients to assure that the 
program can be used by educators with multiple audiences. Initial 
feedback confirms that the program is being well-received.
                    consumer research and evaluation
    NCI always includes an evaluation component in its strategic 
communication planning efforts. Formative and process evaluation 
techniques, including focus groups, omnibus surveys, in-depth telephone 
interviews, and bounce-back card analysis allow NCI to gauge the 
knowledge, attitudes, and behaviors of minority and underserved 
audiences in order to focus program efforts and develop effective 
messages.
                    seeking input for nci activities
    NCI actively reaches out to receive input on research programs and 
its overall research agenda from affected minority and medically 
underserved communities, their health providers, and advocates.
    For example, the NCI Director's Consumer Liaison Group (DCLG), 
multicultural in its membership, helps NCI involve advocates from 
minority organizations and representatives of underserved populations 
in a variety of NCI activities. One of the DCLG's activities was to 
involve such advocates and representatives in a number of advisory and 
working groups at NCI. These included the Clinical Trials 
Implementation Group and the Progress Review Groups, which assist in 
defining and prioritizing the national research agenda for particular 
cancer sites, including breast, prostate and lung cancers.
                               conclusion
    The NCI must, as I have said, written and acted on, address the 
questions of the unequal burden of cancer. To act on the many excellent 
recommendations will require additional resources. It is important to 
remember that the root of the unequal burden of cancer is, in part, a 
reflection of unequal resources, access, power and opportunities in our 
society. Ultimately, this unequal burden will only be readdressed by 
taking responsibility to correct both historic and persistent 
inequities. I say this not to shirk responsibility, but to reinforce 
the IOM committee's position that NCI alone will not solve the 
question. We have been and are committed to better addressing our 
responsibilities, as outlined earlier in my remarks, relevant to 
reducing the unequal burden of cancer.
    I will be happy to answer any questions.

                 summary statement of dr. otis brawley

    Senator Specter. We turn now to Dr. Otis Brawley, Assistant 
Director of the Office of Special Populations Research at the 
National Cancer Institute, a commissioned officer of the U.S. 
Public Health Service, and a member of the American Prostate 
Cancer Committee. He received his medical degree from the 
University of Chicago.
    Welcome, Dr. Brawley, and the floor is yours.
    Dr. Brawley. Thank you. I will try to be very brief.
    I just want to point out that there are issues here of what 
is relevant research to minorities and the underserved and what 
is research that is specific to minorities and the underserved, 
and that is an issue that perhaps we can talk about a little 
bit more.
    I would contend that the most relevant research to a 
Hispanic or a black woman who may get cancer in the next 10 or 
15 years is for the National Cancer Institute to do the 
research which is going to lead to the best treatment, best 
diagnosis, and perhaps best prevention of that cancer. And 
indeed, the best research for that Hispanic or black individual 
is the same as the best research for a white individual who 
might be in the same circumstances.
    One of the things that we worry about when we look at 
budget issues that are very specific or very relevant is we are 
very concerned that we are segregating minority research into 
one particular area of the institute. We work very hard to 
integrate minority research into every program within the 
Cancer Institute.
    And I will close by pointing out that there is an element 
of the IOM document which was very important to me and I think 
needs to have shed a little bit more light on. Some of the most 
important research that we at the Cancer Institute have 
conducted is research that shows that equal treatment yields 
equal outcome and race is not a factor in that outcome. Some of 
the most important research we have also done are patterns of 
care studies to show that there is not equal treatment in the 
United States.

                           prepared statement

    There is a substantial number of minority individuals, be 
they black, Hispanic, or poor white, who do not get adequate 
treatment. And as the IOM report pointed out, that is, a social 
question to be addressed beyond the purview of the National 
Cancer Institute, and that is how we ultimately will bring 
decreases in cancer mortality amongst minorities as we have 
seen dramatic decreases in the last 5 years in the majority 
population.
    I will stop at that point.
    Senator Specter. Thank you very much, Dr. Brawley.
    [The statement follows:]
               Prepared Statment of Otis W. Brawley, M.D.
    I thank you for the opportunity to appear here. I wish to briefly 
add just a few things after Dr. Klausner's opening statement. It is my 
belief that the most relevant research to a Black or Hispanic person 
who might develop cancer in the future is research aimed at developing 
optimal prevention, detection, and treatment of the disease. We all 
need to appreciate that the same research, most relevant to that Black 
or Hispanic person, is also the most relevant research to a white or 
majority person. I wish to note some of the most important research 
that the National Cancer Institute has sponsored shows that equal 
treatment yields equal outcome regardless of race. That is to say that 
race is not a factor in outcome when optimal treatment is given. 
Indeed, Congress said this was a question relevant to minority health 
in the NIH Revitalization of 1993. Other very important NCI sponsored 
patterns of care studies show that there is not equal treatment. 
Blacks, Hispanics and primarily the poor are more likely to get less 
optimal therapy. This body of data has been developed by the NCI over 
the past ten years. Half of the mortality difference between Black and 
White women in breast cancer is directly related to a larger proportion 
of Black women receiving less than optimal medical care. The IOM study 
clearly states that the decline in mortality that has recently been 
seen in some American populations is due to improvements in screening, 
diagnosis, and treatment. Improvements developed in research that the 
NCI has largely sponsored. An important fact that I hope is not 
overshadowed is that a large proportion of the problem in minority 
health is people not getting this optimal care. This is not an issue 
just for the NCI, it is a societal issue. In coding research, there are 
a number of projects that include people of all races and ethnicities 
with cancer but have particular relevance to an ethnic minority that is 
disproportionately affected by that cancer. The Cancer institute 
reported that it spent 124 million dollars in supporting minority 
participation in projects relevant to minority health. I want to point 
out there is a is a difference in research relevant to minority health 
versus research targeted to minority health. There are specific 
projects that are targeted to a specific question pertinent to a 
minority population. The NCI calculated its spending on projects 
targeted to minority health as 43.9 million dollars among 127 projects. 
I am amazed that the IOM developed an estimate of 24 million dollars 
and that they chose to compare it to the 124 million dollars in 
relevant funding. Again I thank you for the opportunity to appear and 
discuss this study on this important topic.

               ethnic minorities prone to certain cancers

    Senator Specter. I began with a threshold question and that 
is the question as to why some ethnic minorities are more prone 
to certain cancers. The explanation given here about the 
consequences of a finding less likely to survive those cancers 
is understandable in terms of access to medical care, to 
diagnosis, and to treatment. But starting at the very base, 
what is the explanation, if one is available, as to why ethnic 
minorities are more prone in the first place to have certain 
kinds of cancers. Dr. Haynes, would you care to respond to 
that?
    Dr. Haynes. Yes; I will be happy to respond to that.
    We do not know all of the answers. In fact, this is the 
reason why this research is so important.
    What we do know, however--and this is not confined to 
minorities--is that cancer is strongly related to a lifestyle, 
diet, and these factors are most likely the important factors. 
And this is one of the main reasons why the committee 
emphasizes emphasis on ethnic groups' behavior, lifestyle, 
rather than on race.
    Senator Specter. The study discloses that African American 
men, illustratively, had unusually high rates of prostate 
cancer. Dr. Haynes would that be related to diet, lifestyle? Or 
tell me how it might be.
    Dr. Haynes. It could be. If indeed there are things in our 
diet, which we do not always understand--in fact, we know very 
little about nutrition and its role in cancer. We know about 
diet in general but not about the nutrients in the diet. It is 
entirely possible, and that is the reason why we should be 
studying why is the rate so low in the Chinese Americans and so 
high in the African Americans.
    Senator Specter. Will you repeat that last statement 
please?
    Dr. Haynes. Why is the mortality from prostate cancer so 
low in Chinese Americans and so high in African Americans. 
These kinds of studies we think will throw a great deal of 
light to answer questions which we cannot now fully answer. I 
believe that the institute agrees with that.
    Senator Specter. And another finding of a similar 
generalized nature, people of Asian descent are more likely to 
develop stomach and liver cancer than whites. Dr. Klausner, let 
me direct the question to you as to an explanation. Anything 
beyond what Dr. Haynes has said?
    Dr. Klausner. Well, yes. Probably for liver cancer and also 
nasopharyngeal cancer, which is another relatively common 
cancer in the Asian population, relatively rare in the American 
Caucasian population, relates to exposure to viruses, hepatitis 
B, other hepatitis viruses and Epstein-Barr virus for the 
nasopharyngeal cancer.
    So, the issue, of course, is as Dr. Haynes said. Exposures, 
lifestyle, diet, and all of its complexity, which is the target 
of much of our research, is illustrated by these very different 
patterns of cancer--not only overall cancer but each individual 
cancer. The patterns of cancer are different and much of this 
can be related, for example, to geographic origin or different 
ethnic groups because of the association of behaviors, diet, et 
cetera, and often occupational exposures that are 
differentially distributed among different groups. All of these 
things are being looked at.
    For some we have answers. For others we do not.
    Senator Specter. Could you amplify why the geographic 
factor would be relevant?
    Dr. Klausner. Well, again, especially for geographic 
factors, countries of origin are important because there are 
different patterns of exposure to infectious agents which we do 
not talk about that much in terms of cancer but worldwide have 
a significant impact on the incidence of specific cancers, such 
as liver cancer, head and neck cancer, cancers of the immune 
system, and others. So, that is one aspect.
    Another, of course, is that different geographic areas are 
associated with different dietary habits, different exposures, 
et cetera. And that is why our epidemiologic research often 
looks at exposures in the broad sense across different areas of 
the world to try to get at those variables.
    Dr. Brawley. If I might add to that, sir. I do primarily 
prostate cancer work. One of the theories that is currently 
being investigated looking at why people in Scandinavia have 
high rates of prostate cancer versus people in the lower 
regions of Europe, is looking at vitamin D metabolism which is 
directly related to sun exposure or lack of sun exposure during 
long winters. And vitamin D metabolism and calcium metabolism 
may have something to do with prostate cancer.
    Now, that research is being done in Scandinavians, but it 
also has tremendous relevance to blacks who get prostate cancer 
in the United States in terms of eliciting mechanisms of 
carcinogenesis.
    Senator Specter. What about the genetic factor? Perhaps 
that is implicit if not explicit in what you have already 
testified to here, gentlemen. I note from time to time that 
Ashkenazi Jews, for example, have certain kinds of ailments 
that seem to pass down generation to generation. To what extent 
is that a factor, Dr. Brawley?
    Dr. Brawley. Well, it clearly is a factor. In the instance 
of prostate cancer, we do not know exactly how much yet. We 
have been looking at that.
    I prefer to think of these things as more familial as 
opposed to more racial. I would think of them as things that 
occur in families that tend to be Ashkenazi Jewish in your 
example or families that tend to be black because, especially 
as we get more interracial and intercultural, the genes that 
cause these diseases are not necessarily going to be correlated 
with skin color.
    Senator Specter. Well, Ashkenazi Jews, for example, are 
much broader than a family, as are African Americans, a whole 
race.
    Dr. Klausner, I see you straining at the bit. [Laughter.]
    Dr. Klausner. Well, we do know something about that that 
would be interesting, and that is, while Ashkenazi Jews 
represent people that come from a broad area of Europe, it 
appears that about 1,000 years ago all of the Ashkenazi Jews 
currently in the world could trace their descent from a very 
limited number of people, perhaps about 1,000 or a few 
thousand. That type of historical bottleneck----
    Senator Specter. Where did they start from? Ukraine?
    Dr. Klausner. No; I think this was actually more in western 
Europe. Then they moved to Germany, which is where the name 
Ashkenazi comes from, and later moved further east into 
Ukraine, Lithuania, Poland, and those areas.
    Senator Specter. Someone would leave Germany to go to 
Ukraine? [Laughter.]
    Dr. Klausner. It was a lot different then.
    Senator Specter. My father came from Ukraine. I do not 
think he had any options. [Laughter.]
    Let me go to a very tender point, having started with 
lesser tender points, and that is the amount of money devoted 
here. My briefing materials tell me that NCI reports $124 
million allocated to research and training for ethnic 
minorities and underserved groups in fiscal year 1997 while the 
IOM believes the actual figure is only $24 million. Let us 
start with you, Dr. Haynes.
    Dr. Haynes. Yes; that is the issue which I mentioned on 
which there was only partial agreement.
    Senator Specter. Where is the partial agreement? On the $24 
million? [Laughter.]
    There is disagreement on the $100 million? I would not call 
that partial agreement, but go ahead.
    Dr. Haynes. NCI accounts for research on minorities in two 
categories. In category one is the research that is 
specifically directed toward minorities. In category two, it is 
general research in which minorities may be included, and in 
that case they allocate on the basis of the percentage of the 
population in those studies.
    We state that allocation on that basis is not the best way 
to approach the problem. A better way to approach the problem 
would be on the research question that is involved. Then the 
allocation can be made on that basis. If indeed there is a 
research study of a general population and minorities are 
involved, why not be able to say that as a result of that 
study, the way it is designed, you should be able to answer 
questions about minority populations. And I believe we agree on 
that.
    Dr. Klausner. Yes.
    Dr. Haynes. But somehow when we make that statement, it 
gets confused with the idea of segregating research. We are not 
recommending that research be segregated. We are recommending 
that research be done across and within ethnic groups; that is, 
you compare various ethnic groups, but then within a large 
macro-ethnic group, you look at subgroups. And there are times 
when you would do one kind of research, there are other times 
when you do both. And we are not trying to segregate the 
research. So, that is the confusion that has arisen about our 
criticism.
    Senator Specter. Well, I did not follow all of your answer, 
but let me focus back in on $124 million versus $24 million. Do 
you stand by that kind of divergence, that you think NCI has 
only spent $24 million on this particular line?
    Dr. Haynes. What we are saying is it is clear about the $24 
million. The rest of it is not clear if it is based merely on 
the proportion of people in the study. We want to know was the 
study designed in such a way that it can, indeed, give you an 
answer to questions about minority populations.
    Senator Specter. Dr. Klausner, so what is your evidence 
that you spent $124 million for ethnic research and underserved 
people?
    Dr. Klausner. Well, we provided all of that data. Let me 
give an example of what we code in terms of partial----
    Senator Specter. You say you supplied all that data?
    Dr. Klausner. Yes; to the IOM committee, and obviously 
there is a difference of agreement.
    Let me give you an example of a study that we code as 
partial, not 100 percent. There is something called the 
prostate cancer outcome study. It is a large community-based 
study that is trying to understand the differences in 
detection, diagnosis, and treatment patterns across different 
groups, different populations. Within that, we are asking 
explicit questions about the difference in treatment among 
whites, Hispanic men, and African American men.
    We calculate that about 10 to 20 percent of the total cost 
of the project is aimed at directly answering questions about 
the different burden of cancer. That is an example of partial 
funding which would not be allowed in the accounting of the IOM 
and so is above the $24 million. The majority of the difference 
between the $24 million and the $124 million--not all of it--is 
exactly these projects where pieces of the projects are aimed 
specifically at addressing the questions, we think, relevant to 
the unequal burden of cancer.
    Senator Specter. How much of the balance of $100 million 
could be accounted for in that way?
    Dr. Klausner. Well, in terms of the issue of just counting 
based upon the fraction of minorities that participate, for 
example, in clinical trials, that total amount would be $18 
million, which would then be a difference of the $124 million. 
But even there, of the $18 million from our clinical trials, 
only about half of that would come from accounting based upon 
looking at proportional representation within treatment trials. 
A lot of that is specifically within our clinical trials aimed 
at efforts to increase the accrual of minorities and 
underserved and efforts to ask specific questions.
    So, my understanding in looking at our portfolio and our 
analysis is that the majority of that difference does represent 
direct investments aimed at the issues raised by the IOM 
report.
    Perhaps Dr. Brawley can----
    Dr. Brawley. Yes; we are answering two questions here. One 
is research relevant to minorities, which is what the $124 
million is, and the second is research directed specifically at 
research questions related to minorities.
    Now, we answered to the relevancy with the $124 million. 
Actually I have here a copy of a document that we provided to 
the IOM senior staff, and if you would like to look in the 
boxes of data provided to the IOM, you will find it. In 1997, 
we said that we had $43.9 million through 127 projects and we 
provided a synopsis of each one of the 127 projects that was 
directed specifically at minorities. So, indeed, I think the 
question is why we said $43.9 million and they said $24 
million, and not why we said $124 million and they said $24 
million.
    Senator Specter. Dr. Haynes, what is your evaluation of 
that explanation?
    Dr. Haynes. Our evaluation is that it would be better for 
NCI--incidentally, this is not only the National Cancer 
Institute. It is our understanding that NIH does this all the 
time. It is an easy way of giving an answer to the question, 
and I am not sure whether it is a question you want answered, 
but it is an easy way of addressing the question.
    We think it would be better to do what Dr. Klausner just 
did, to analyze the design of the study to determine whether it 
was specifically determined by that study that you could answer 
some questions about minorities.
    Senator Specter. Well, this is a very fundamental question 
as to resource allocation, and the Congress has been very 
generous with the National Institutes of Health in recent 
years, adding some $2 billion last year. And I want to get to 
the bottom of it. I want your evaluation specifically, and we 
will follow up with staff, as to what resources are being 
allocated because on our oversight function, we want to be sure 
that minorities and underserved are fairly treated, and there 
is a big gap between $24 million having been expended and $124 
million.
    Now, Dr. Klausner is contending essentially that the money 
is under a different umbrella but it is being directed to 
minorities and underserved. But I would like to examine that, 
and it may be that it could be directed more specifically to 
those groups. You have made a very detailed study, and let us 
really find out what the facts are.
    Senator Harkin, the ranking member, is in a party caucus 
himself at this time. He otherwise would have been here.
    We have been joined by our very distinguished chairman of 
the full appropriations committee, Senator Stevens. Senator 
Stevens, would you care to make a statement or ask a question?
    Senator Stevens. Well, I am sorry to be late. I had some 
meetings also.
    But I am delighted you are having this oversight, and I 
think that we should have more oversight before we get around 
to allocating funds this year. I am really very interested in 
the recommendations of the Institute of Medicine, but I am also 
looking forward to meeting with Dr. Klausner about just the 
overall allocations of NCI.
    It does seem to me, as a cancer survivor, there is little 
information out there for survivors. Those people who really 
need the help more than any are those that are uninsured and 
those in the lower income brackets because they just do not 
have the networks that are out there to assist the others.
    We have a network around here. Bob Dole heads it. If Dole 
gets any information, he shares it with everybody. I am 
literally congratulating him for that, not making a pun.
    I believe there are not enough systems that think about the 
survivors. I will be very interested in the comments that you 
receive from the Institute of Medicine.
    I also think that we have to find some way to coordinate 
this research. As I travel around, Mr. Chairman, I find there 
is a great deal of redundancy in the research that is being 
done in the cancer area. I believe there ought to be a better 
way to allocate those funds to target what appears to be areas 
of potential breakthrough in terms of the research patterns.
    I congratulate you for holding this hearing. I represent, 
as you know, a State that is made up of minorities. Most people 
do not realize that. We really do not have a majority 
population in Alaska. We have a series of minorities, Alaska 
natives and blacks, and a great many of the families from the 
Pacific Rim, the Asian groups, have come to Alaska. So, we have 
a series of minorities. We have a series of very distinct 
problems in a small population base with an enormous area to 
deal with.
    I look forward to working with you and appreciate your 
having this hearing, Mr. Chairman.
    Senator Specter. Thank you very much, Senator Stevens.
    Well, thank you very much, gentlemen. We will be pursuing 
the many questions and I know the National Cancer Institute 
will be replying in some greater detail to the findings that 
you have made, Dr. Haynes. I think it is a very, very 
significant step forward, and we ought to be devoting 
substantial resources to minorities and underserved people 
because they do have less access, and if there is going to be 
an imbalance here, we ought to err a little bit on the side of 
serving people who are unable to serve themselves with their 
own resources. So, thank you very much.

                summary statement of dr. louis sullivan

    Senator Specter. We will now turn to the second panel, Dr. 
Louis Sullivan and Dr. Armin Weinberg.
    Dr. Sullivan comes to the subcommittee, having been here on 
many, many occasions in his capacity as Secretary of Health and 
Human Services where he performed great assistance to the Bush 
administration. He is President of the Morehouse School of 
Medicine in Atlanta since January 1993, a member of numerous 
medical organizations, and the founding President of the 
Association of Minority Health Professionals Schools. Welcome 
again, Dr. Sullivan, and we look forward to your testimony.
    Dr. Sullivan. Thank you very much, Senator Specter, Senator 
Stevens. It is a pleasure to be here before you this morning 
and I certainly had a great experience during my time here in 
Washington. Certainly I am pleased with your continued interest 
and support for improving the health of the American people.
    I want to comment on the report from the Institute of 
Medicine that is under discussion today. I want to begin by 
congratulating Dr. Haynes and the members of the committee that 
is looking at the issue of cancer among minorities and the 
medically underserved. I believe they have done a tremendous 
service to our Nation through this landmark report.
    Mr. Chairman, as President of the Morehouse School of 
Medicine and as principal investigator of the National Black 
Leadership Initiative on Cancer and as former Secretary of 
Health and Human Services, I have spent a great deal of time 
addressing the issue of cancer in ethnic minorities and in 
medically underserved populations.
    It is my hope that the findings of the IOM study will 
prompt NIH officials, researchers, and policymakers to 
strengthen NIH's biomedical research and surveillance programs 
focused not only on cancer but on other diseases as well which 
disproportionately impact our Nation's minority communities.
    All of us recognize NIH as the premier biomedical research 
organization in the world. Indeed, the NIH is at the forefront 
of unprecedented breakthroughs in the fight against disease and 
disability as we approach the next millennium. But as the 
report from the Institute of Medicine shows, NIH needs to 
reevaluate its cancer research portfolio in order to adequately 
address the higher death rates from cancer in our Nation's 
minority and underserved populations.
    Several of the study's findings reinforce what many of us 
have known for many years, and that is the culture, the 
structure, and the programs of the National Cancer Institute 
and NIH as a whole serve the white population well, but fall 
far short in addressing the needs of the Nation's ethnic 
minorities. This is frustrating, Mr. Chairman, because ethnic 
minorities represent the fastest growing segment of our 
population, and as you are already aware, they suffer a 
disproportionate burden of disease and disability.
    As you have already been discussing, one of the findings of 
particular importance is that only 1 percent of the Cancer 
Institute's budget is allocated for research and training 
programs focused on the Nation's ethnic minorities and 
medically underserved groups.
    Now, this finding from IOM is consistent with an article 
published 6 years ago in the Chronicle of Higher Education in 
1993 that demonstrated that less than 1 percent of the funding 
at NIH was dedicated either to African American researchers or 
African American institutions. And although that number may be 
subject to some debate--and there is always disagreement, as 
you have already heard earlier this morning. I will be pleased 
to comment on that--it clearly demonstrates that much more 
needs to be done to address the needs of the Nation's minority 
citizens.
    I am also concerned that targeted programs which have been 
put into place to reverse this trend such as NCI's Office of 
Special Populations Research that Dr. Brawley serves, as well 
as the NIH-wide Office of Research on Minority Health in the 
Director's Office, these offices have not been given the 
resources nor the authority they need to have a significant 
impact on the research direction of NCI or NIH overall.
    For example, the Office of Research on Minority Health was 
established during my tenure as U.S. Secretary of Health and 
Human Services. This was done in part to leverage NCI and the 
other institutes' resources to expand the focus on minority 
health research. That was almost 10 years ago, and as we look 
back, it appears that funding of this office has been used to 
supplant the modest resources available from the individual 
institutes at NIH for research focused on areas of particular 
need for the Nation's minority citizens. That was not the 
intent when these programs and this office was established.
    Mr. Chairman, what is needed is an exponential leap forward 
in the orientation of NIH officials with respect to their 
approach to ethnic minorities and underserved communities. To 
that end, the IOM study recommends the establishment and the 
implementation of a strategic plan to address the cancer 
survivorship needs of ethnic minority and underserved groups. I 
agree with that recommendation and strongly believe that this 
effort should be led by the Office of Research on Minority 
Health.
    To facilitate this undertaking, I believe that this office 
should be elevated to center status, the same way that a year 
ago the Office of Alternative Medicine was elevated to the 
Center for Complementary and Alternative Medicine.
    It is also important that the new center's budget be 
significantly increased. This would provide the Office for 
Research on Minority Health with the necessary organization and 
resources to assume a leadership role in developing a strategic 
plan for minority health research across NIH. It would also 
enable this office to make grants on its own budget for 
important minority health research projects without having to 
go through existing research institutes which in my view have 
not demonstrated sufficient leadership in this area.

                           prepared statement

    Mr. Chairman, the NCI Office of Special Populations can 
also play an important role in expanding cancer research, 
surveillance, and awareness among ethnic minorities and 
underserved populations if it is given the authority to 
coordinate and leverage program activity at NCI. Without the 
authority to help set priorities, to fund programs of special 
benefit to minorities, and to hold other NCI divisions 
accountable for supporting minority research activities, I am 
not convinced that much will change. Simply stated, if we are 
to see meaningful change from what exists today rather than 
continued benign neglect, bold steps are necessary.
    Thank you for the opportunity to present my views on this 
issue, and I look forward to your questions.
    Senator Specter. Thank you very much, Dr. Sullivan.
    [The statement follows:]
              Prepared Statement of Dr. Louis W. Sullivan
    Mr. Chairman and members of the subcommittee, please allow me to 
thank you for this opportunity to present my views on the Institute of 
Medicine's report, The Unequal Burden of Cancer: an Assessment of NIH 
Research and Programs for Ethnic Minorities and the Medically 
Underserved.
    I would first like to congratulate Dr. Alfred Haynes for his 
leadership in chairing the Committee on Cancer Research Among 
Minorities and the Medically Underserved. Dr. Haynes and his colleagues 
have a done a tremendous service to our nation through their work on 
this landmark report.
    Mr. Chairman, as president of the Morehouse School of Medicine in 
Atlanta, principal investigator for the National Black Leadership 
Initiative on Cancer (NBLIC), and former secretary of the U.S. 
Department of Health and Human Services, I have spent a great deal of 
time addressing the issue of cancer in ethnic minorities and medically-
underserved populations. It is my hope that the findings of the IOM 
study will prompt NIH officials, researchers, and policymakers to 
strengthen NIH's biomedical research and surveillance programs focused 
not only on cancer but other diseases as well which disproportionately 
impact minorities.
    I believe that all of us recognize NIH as the premier biomedical 
research organization in the world today. Indeed, NIH is at the 
forefront of unprecedented breakthroughs in the fight against disease 
and disability as we enter the new millennium. However, as the IOM 
report shows, NIH needs to re-evaluate its cancer research portfolio in 
order to adequately address the higher death rates from cancer in 
minority and underserved populations.
    Several of the study's findings reinforce what many of us have 
known for years--that the culture, structure and programs of the 
National Cancer Institute (NCI) and NIH as a whole serve the white 
population well, but fall short in addressing the needs of ethnic 
minorities. This is frustrating, Mr. Chairman, because ethnic 
minorities represent the fastest growing segment of the U.S. population 
and suffer a disproportionately high burden of disease and disability.
    One of the study's findings of particular concern is that only 
about 1 percent of the National Cancer Institute's budget is allocated 
for research and training programs focused on the nation's ethnic 
minorities and medically underserved groups. This finding is consistent 
with an article published in the Chronicle of Higher Education in 1993, 
which demonstrated that less than 1 percent of NIH funding was 
dedicated to African American researchers or African American 
institutions. Although that number may be subject to some debate, it 
clearly demonstrates that much more needs to be done to address the 
needs of the nation's minority citizens.
    I am also concerned that targeted programs which have been put in 
place to reverse this trend, such as NCI's Office of Special 
Populations Research and the NIH-wide Office of Research on Minority 
Health (ORMH), have not been given the resources nor the authority they 
need to have a significant impact on the research direction of NCI or 
NIH overall. For example, ORMH was established during my tenure as 
secretary of the Department of Health and Human Services, in part to 
leverage NCI and other institutes' resources to expand the focus on 
minority health research. Instead, it appears that ORMH funding has 
been used to supplant the modest resources available from individual 
institutes for research focused on areas of particular need for the 
nation's minority citizens. Clearly, that was not the intent when these 
programs were established.
    Mr. Chairman, what is needed is an exponential leap forward in the 
orientation of NIH officials with respect to their approach to ethnic 
populations and underserved communities. To that end, the IOM study 
recommends the establishment and implementation of a strategic plan to 
address the cancer survivorship needs of ethnic minority and 
underserved groups. I agree with this recommendation and strongly 
believe that this effort should be lead by the Office of Research on 
Minority Health.
    To facilitate this undertaking, I believe that ORMH should be 
elevated to ``center status'', in the same way that the Office of 
Alternative Medicine was recently elevated to the Center for 
Complementary and Alternative Medicine. It is also important that the 
new center's budget be significantly increased. This would provide ORMH 
with the necessary organization and resources to assume a leadership 
role in developing a strategic plan for minority health research across 
NIH. It would also enable ORMH to make grants from its own budget for 
important minority health research projects without having to go 
through the existing institutes, which have not demonstrated sufficient 
leadership in this area.
    Mr. Chairman, the NCI Office of Special Populations can also play 
an important role in expanding cancer research, surveillance, and 
awareness among ethnic minorities and underserved populations if it is 
given the authority to coordinate and leverage program activity at NCI. 
Without the authority to help set priorities, to fund programs of 
special benefit to minorities, and to hold other NCI divisions 
accountable for supporting minority research activities, I am not 
convinced that much will change. Simply stated, if we are to see 
meaningful change, rather than continued benign neglect, bold steps are 
necessary.
    Mr. Chairman, thank you for the opportunity to present my views on 
this important issue. Again, I offer my congratulations to Dr. Haynes 
and his colleagues. I will be pleased to respond to any questions that 
you may have.

                summary statement of dr. armin weinberg

    Senator Specter. We turn now to Dr. Armin Weinberg, cochair 
of the----
    Senator Stevens. Sorry, Dr. Weinberg. I have got to go.
    Senator Specter. Dr. Armin Weinberg is cochair of the 
Intercultural Cancer Council; Director of the Center for Cancer 
Control Research at Baylor College of Medicine. He received his 
Ph.D. in anatomy at Ohio State University and is a member of a 
special review committee on breast cancer education initiatives 
at NIH.
    Thank you for joining us, Dr. Weinberg, and we look forward 
to your testimony.
    Dr. Weinberg. Thank you very much, Senator.
    With your permission, I will ask that my entire statement 
be submitted for the hearing record, and in the interest of 
time, I will try and----
    Senator Specter. The full statement will be part of the 
record, and we look forward to your summary.
    Dr. Weinberg. OK.
    I would like to say that I am presenting this report on 
behalf of the Intercultural Cancer Council and my cochair, Dr. 
Lovell Jones, who is also here with me, from the M.D. Anderson 
Cancer Center. We appreciate the opportunity to be here today.
    The ICC, the Intercultural Cancer Council, is the Nation's 
largest cancer coalition addressing the tragic disparities in 
the incidence and mortality rates in the ethnic minority and 
medically underserved communities, which, by the way, includes 
respective survivors from each of those communities.
    The ICC commends your leadership. Your directive launching 
the IOM report required for the first time the NIH's 
accountability in how it establishes and measures its ethnic 
minority and medically underserved research commitment. We urge 
the report be used as a springboard to launch a more 
constructive and focused national effort.
    The IOM deserves many thanks for the fine work led by Dr. 
Alfred Haynes, the committee, and the IOM study staff. While 
the report acknowledges the triumphs and commitments of the NIH 
and the NCI, it also correctly identifies current areas of 
deficiency which must be addressed. The study, we believe, 
creates a wonderful opportunity for the interested cancer 
community, including the NIH, as well as the Centers of Disease 
Control and Prevention, and other public and private sector 
organizations, to look for better solutions as we approach the 
millennium.
    The ICC's No. 1 recommendation today to the appropriations 
committee is to ensure that NIH and NCI undertake the necessary 
steps to implement the IOM recommendations without delay. 
Expeditiously, the agency must develop an implementation plan 
that addresses these recommendations. It must, I think, commit 
itself to be accountable for achieving the outcomes and results 
envisioned in the recommendations. It must develop and adhere 
to a reasonable but expeditious timetable for genuine systemic 
and cultural change, and secure adequate funding resources 
necessary to address priority areas such as research training, 
cancer surveillance, and database enhancements.
    The changes called for in the study require substantial 
dollars and a significant retooling of the agency culture and 
priorities. We urge Congress to require the General Accounting 
Office to undertake periodic independent and objective 
assessments of the progress in this area. In fact, the Congress 
must hold all of us accountable to solving the problems and 
eliminating the inadequacies identified in this benchmark 
report. It is an investment we cannot afford to postpone. These 
groups are the fastest growing population in the United States 
and will represent the majority in the millennium. Ignoring 
these demographics is myopic and injurious to our long-term and 
national domestic interests.
    While all the IOM findings are significant, we specifically 
call the committee's particular attention to the box summary 
committee findings found on pages 3 to 5 in the IOM summary 
report. We would like to focus immediate concern on a couple of 
things.
    The first is the issue of NCI and the parent organization 
having no blueprint or strategic plan to direct or coordinate 
research among these minority and underserved populations. This 
does need to be addressed.
    The second point is that even though the budget that was 
discussed by you so aptly and Dr. Klausner and Dr. Haynes was 
well founded. Either way, whether it is $124 million or $24 
million, it is still too small. It is too little given the 
amount of money that we have available to spend in this area.
    With regard to the discrepancies, I will be happy to 
comment, if we have time, further.
    Another factor which we would like to mention is that we 
were disappointed to see that the Minority Health Initiative 
funding, under the Office of Minority Research mentioned by Dr. 
Sullivan, appears to have been supplanted rather than leveraged 
in its use in many instances.
    Regarding the necessary database to monitor these 
activities, SEER is a fine database for giving us a national 
snapshot, but it has a blind spot that does not address the 
people of our constituencies. While we support the IOM 
recommendations, we must clarify for the record today that the 
Centers for Disease Control and Prevention is responsible by 
statute for establishing population-based registries. We urge 
the CDC to accelerate its efforts to improve the quality of 
this program. We recognize that this is a relatively new 
program that remains sorely underfunded. And just as we urge 
you in the Congress to increase SEER funding, we urge Congress 
to increase funding substantially for the Centers for Disease 
Control's registry effort.
    Regarding defining race and ethnicity, although we agree 
that there is no longer a biological basis for race, it should 
not be misunderstood to suggest the absence of a need for 
targeted studies. In fact, quite the opposite. It represents a 
substantial need to do it.
    Regarding research training, all I can say is that long-
term stable funding for research must receive highest priority. 
Clearly, no 21st century solutions to this problem can be 
achieved without adequate involvement of minority researchers 
and health care providers at all levels.
    Mr. Chairman, we support the NCI and NIH research missions 
and the substantial increases that are proposed from the 
Federal Government's renewed war on cancer. But any such 
funding increases must place a priority on addressing the 
disparate burden cancer presents to ethnic minority and 
medically underserved populations.
    In closing, we would confirm that the ICC agree that the 
war on cancer must be fought and won across Federal Departments 
and agency lines. Your committee and the Senate Cancer 
Coalition recognize the challenges here. We believe that it is 
time to designate a highly visible, national coordinating 
entity.

                           prepared statement

    In closing, we cannot allow this study to be shelved----
    Senator Specter. Is this your final closing, Dr. Weinberg?
    Dr. Weinberg. It is. It is. Thank you. I am sorry for that 
too.
    We cannot allow the study to be shelved. Instead of burying 
any bad news it contains, it must be utilized as a baseline 
framework against which we measure future progress and enhance 
accountability.
    [The statement follows:]
              Prepared Statement of Dr. Armin D. Weinberg
    Good morning. I am Dr. Armin D. Weinberg, Co-Chair of the 
Intercultural Cancer Council and Director of the Center for Cancer 
Control Research at Baylor College of Medicine. I also want to 
introduce the ICC Co-Chair, Dr. Lovell A. Jones, Professor and 
Director, Experimental Gynecology-Endocrinology at the University of 
Texas M.D. Anderson Cancer Center in Houston, Texas. We appreciate the 
opportunity to be here today on behalf of the Intercultural Cancer 
Council (ICC). The ICC is the nation's largest cancer coalition 
addressing the tragic disparities in incidence and mortality rates in 
the ethnic minority and the medically underserved communities.
    Mr. Chairman, the ICC commends your leadership in initiating the 
Institute of Medicine (IOM) Study to assess the programs of research at 
the National Institutes of Health (NIH) relevant to ethnic minority and 
medically underserved populations. Chairman Specter, you and your staff 
recognized several years ago that ethnic minorities and medically 
underserved populations frequently experience a disproportionately 
greater burden of cancer. Your directive launching the IOM report 
required, for the first time, the NIH's accountability in how it 
establishes and measures its ethnic minority and medically underserved 
research commitment.
    We applaud you and your staff for immediately focusing on the IOM's 
findings with today's timely hearing. We urge the Congress and the 
Clinton Administration to use the IOM report as a springboard to launch 
a more constructive and focused national effort to address the 
disparate impact of cancer on ethnic minorities and the medically 
underserved.
    The IOM deserves kudos for the one work of Dr. Alfred Haynes' 
Committee on Cancer Research Among Minorities and the Medically 
Underserved (IOM Committee) and the IOM's study staff. What this group 
produced is a long needed, independent assessment and baseline report 
from which future progress can be measured in a number of significant 
areas. The IOM Committee's challenging task has cut across institute 
and agency lines. While the report acknowledges the triumphs and 
commitment of the NIH and National Cancer Institute (NCI), it also 
correctly identifies current areas of deficiency--in the cancer program 
generally and minority cancer research arena specifically--which must 
be addressed to tackle effectively the cancer burden among ethnic 
minorities and the medically underserved.
    The IOM Study creates a wonderful opportunity for the interested 
cancer community--including the NIH and NCI, as well as the Centers for 
Disease Control and Prevention and other public and private sector 
organizations--to look for better solutions as we approach the 
millennium. In testifying here today, Mr. Chairman, the ICC pledges to 
do everything we can to work with you, the NIH and NCI, and our private 
sector partners to assist in tackling the challenges ahead. The ICC's 
number one recommendation is that the Appropriations Committees ensure 
that NIH and NCI undertake the necessary steps to implement the IOM 
recommendations without delay. The agency must:
  --Expeditiously develop an implementation plan to address the 
        specific IOM recommendations;
  --Commit itself to be accountable for achieving the outcomes and 
        results envisioned in the IOM recommendations;
  --Develop and adhere to a reasonable but expeditious timetable for 
        genuine systemic and cultural change; and
  --Secure adequate resources necessary to address priorities 
        identified by the IOM, such as research training, cancer 
        surveillance and database enhancements.
    Everyone must recognize that the changes called for in this study 
require substantial dollars and a significant retooling of agency 
culture and priorities. In fact, the Congress must hold all of us 
accountable for solving the problems and eliminating inadequacies 
identified in this benchmark report.
    While implementation of many IOM recommendations will require a 
significant investment of federal dollars, this is an investment that 
we cannot afford to postpone. Ethnic minority and medically underserved 
groups are the fastest growing populations in the United States. These 
populations will represent the majority in the millennium. We owe it to 
our nation and to these population groups to reverse the disastrous 
trends and cancer burdens in these communities. Ignoring these 
demographics is myopic and injurious to our long-term and national 
domestic interests.
    While all the IOM findings are significant, we specifically call 
the Committee's particular attention to the ``Box'' Summary of 
Committee Findings found on pages 3-5 of the IOM ``Summary'' of its 
report entitled ``The Unequal Burden of Cancer.'' We would like to 
focus on three areas of immediate concern:
  --NCI and its organization, The National Institute of Health, have 
        ``no blueprint or strategic plan to direct or coordinate'' 
        research on cancer among ethnic minority and underserved 
        populations.
  --NCI actually spent only about 1 percent of its budget--about $24 
        million--on research concerning ethnic minorities and 
        underserved populations, while NCI had claimed to have spent 
        $124 million in 1997. Even if its claims were correct, that 
        would represent only 5 percent of NCI's budget, obviously not 
        nearly enough to effectively address the research needs of 
        these groups.
  --The NCI ``lacks the necessary database concerning the 
        disproportionate cancer incidence, mortality and survival rates 
        among ethnic minorities and the medically underserved that 
        would permit it to develop and evaluate effective cancer 
        control strategies for these populations.''
                         lack of strategic plan
    No blueprint or strategic plan to direct or coordinate NIH's and 
NCI's ethnic minority and medically underserved cancer research 
activity appears to exist. Furthermore, overall funding to address the 
needs of ethnic minority and medically underserved populations is 
woefully inadequate. The agency must develop a game plan to address and 
measure its progress in the ethnic minority and medically undersexed 
cancer arena.
               nci accounting and spending discrepancies
    The IOM study found some disturbing discrepancies in how NCI 
accounts for its commitment to research efforts affecting ethnic 
minorities and the medically underserved. While NIH says it spent $124 
million on research relevant to these populations in 1997, the study 
documents the real number at less than one-fifth of that amount--or 
about $24 million--barely 1 percent of the NCI budget. One reason is 
that NCI included research involving ethnic minorities and the 
medically underserved, but which was not actually targeted to these 
populations. We were chagrined to learn this and urge that NCI abandon 
its current accounting methods and adopt the modifications set forth in 
the IOM report.
    Another factor that further skews NCI's accounting estimate is the 
lack of a clear and consistent definition of ``special populations,'' 
as pointed out in the IOM report. Without clear definition of what 
constitutes and who comprises a special population, accurate accounting 
and understanding of the complex research allocation and funding 
process are impossible. Semantics is not the issue. The actual impact 
of these definitions will be far-reaching, particularly as we move 
forward into the new millennium and witness the changing demographic 
trends I alluded to earlier. The ICC stands ready to help NIH develop 
more precise language to clarify critical terminology and put an end to 
the confusion that now abounds.
                       insufficient nci spending
    Even if one were to acknowledge the NIH numbers as accurate, 
clearly the paltry amount dedicated to focused ethnic minority and 
medically underserved concerns contrasts starkly with dedicated NIH 
research priorities such as women's health research. In addition to 
inaccurate accounting, we were also alarmed to learn from the IOM 
report that the Minority Health Initiative funding that is administered 
by the NIH Office of Research on Minority Health (ORMH) appears to have 
supplanted rather than leveraged NCI resources for important research 
and program activities in many instances. Therefore, the $24 million 
figure given in the IOM Study in reality is even less because it may 
include other ORMH research funding. For example, $1.75 million of the 
$6 million listed as dedicated to ORMH research actually includes 
funding for an adolescent minority HIV treatment project. In light of 
these findings, the ICC urges the Senate Appropriations Subcommittee to 
ensure the integrity of these dollars by directing that ORMH funding is 
not, in fact, utilized inappropriately.
                      nci lacks necessary database
    The federal government is the most important single player in 
cancer research, not only because it is a major provider of funding, 
but also because the statistical data it compiles on cancer serves as a 
guide for how research resources are to be allocated. NCI's 
Surveillance, Epidemiology and End Results (SEER) program builds the 
statistical database that serves as the means of measuring cancer rates 
in the United States. This is done by gathering data from selected 
geographic areas around the country to represent the nation as a whole. 
This is fine for giving us a national snapshot, but the SEER program 
has blind spots that obscure many of the populations we serve.
    Therefore, we agree with the IOM recommendations to enhance the 
SEER program and respectfully request that Congress provide requisite 
funding. The ICC applauds the Committee for recognizing the need to 
strengthen the U.S. Cancer Surveillance system.
    While we support the IOM recommendations, we must clarify for the 
record today that the Centers for Disease Control and Prevention (CDC) 
is responsible by statute for establishing population-based cancer 
registries through the National Program of Cancer Registries (NPCR). 
CDC's mission, with the passage of the Cancer Registries Amendment Act 
of 1992, is to collect data for analyzing the cancer burden in the U.S. 
as well as to enhance the ability of states to use local data for 
program planning, evaluation and resource allocation. Further, this 
data will strengthen our capacity to identify important applied 
research questions.
    While we urge the CDC to accelerate its efforts to improve the 
quality of its program, we recognize that this relatively new program 
remains sorely underfunded. Additionally, the ICC urges the NCI to 
strengthen its collaborative efforts with the CDC, NPCR and other 
cancer registries through the National Coordinating Council for Cancer 
Registries. Just as we urge Congress to increase SEER funding, we urge 
Congress to increase funding substantially for CDC's national cancer 
registry program.
    The ICC also urges Congress to focus attention on the IOM's 
concerns relating to several additional areas.
                      defining ethnicity and race
    The ICC is grateful to the IOM for their thoughtful discussion and 
recommendations relating to the definition of ethnicity and race. The 
ICC agrees with the conclusions stated in the IOM report. However, even 
though we agree there is no biological basis for race, this should not 
be misunderstood to suggest the absence of a need for targeted studies 
on cancer outcomes in ethnic minority and medically underserved 
populations. In fact, the IOM report substantiates that far more needs 
to be done in this area.
    As noted numerous times in the report by the IOM Committee, we can 
still benefit from understanding differences in health status between 
the original four racial definitions. The ICC welcomes the opportunity 
to participate in helping to formulate these definitions. Furthermore, 
while the ethnic definitions are in development, as the IOM report 
points out, there still are numerous benefits to be derived from 
current studies directed at groups as they are currently defined.
              changing the nih culture: research training
    The IOM report clearly documents the dearth of ethnic minority 
research investigators. One major concern identified by the ICC since 
its inception relates to the need for an institutional and cultural 
commitment on the part of NIH which will permit and stimulate a 
substantial increase in the number of trained minority investigators. 
The ICC endorses immediate implementation of the IOM's research 
training recommendations and inclusion of this priority in a strategic 
plan. Long-term, stable funding for research training must receive 
highest priority--clearly, no 21st century solutions to the problems 
cited by IOM can be achieved without adequate involvement of minority 
researchers and providers at all levels.
    Mr. Chairman, the ICC strongly supports the NIH and NCI research 
missions and substantial increases in the amount of federal funds 
dedicated to a renewed war on cancer. But any such funding increases 
must place priority on addressing problems identified in the IOM study 
and redressing the research inadequacies in dealing with cancer in 
ethnic minority and medically underserved populations.
    The agency must focus on and expand its commitment to behavioral 
and epidemiological research specifically, and translational research 
overall. Addressing the disparate burden cancer presents to ethnic 
minority and medically underserved populations must become a national 
priority. This requires the commitment of all involved federal 
agencies, including the Centers for Disease Control and Prevention, the 
Department of Defense, the Environmental Protection Agency and other 
HHS programs. The IOM's report confirms an earlier ICC recommendation 
that the time has come to designate a highly visible national cancer 
coordinating entity. The war against cancer must be fought and won 
across federal department and agency lines. Your Committee and the 
Senate Cancer Coalition recognize the challenges inherent in addressing 
the necessary federal agency systemic and cultural changes. We applaud 
your leadership and pledge our support and commitment toward making 
substantial progress an we move into the next century.
    In closing, we hope the IOM Report serves as a ``call to action.'' 
This hearing today can provide a fruitful beginning of a new national 
commitment to address the disparate burden of cancer on minority and 
medically underserved populations in America today. We cannot allow 
this study to be shelved. Instead of burying any bad news it contains, 
it must be utilized as the baseline framework against which we measure 
future progress and enhance accountability in the expenditures of 
precious federal dollars devoted to the war on cancer. If the agency 
takes this report seriously, we are confident agency culture will 
change and a refocused and expanded priority on cancer among ethnic 
minorities and the medically underserved will emerge. We urge Congress 
to require the General Accounting Office (GAO) to undertake periodic, 
independent, and objective assessments of NIH and NCI progress. On its 
part, the ICC pledges its strong support and cooperation both to 
Congress, the National Institutes of Health, and the National Cancer 
Institute.

                            adequate funding

    Senator Specter. Thank you very much, Dr. Weinberg.
    Dr. Sullivan, starting with you--and regrettably we do not 
have much time for questions--when you posed the issue of 
having the leveraging come out of the Office of Research on 
Minority Health, that is a pattern which occurs from time to 
time. Something in HHS is going to look into NCI and see to it 
that their particular group is accorded adequate funding. It 
touches on what Dr. Weinberg says perhaps on a blueprint which 
he is looking for.
    As the former Secretary of the whole Department, Dr. 
Sullivan, how realistic is it to have somebody who is a subset 
in HHS--that that director move over and try to exert some real 
influence on NCI, Dr. Klausner--I am going to give you a chance 
to answer this question, Dr. Klausner--in NCI? What are the 
realities of it? Your long arm comes from this building a block 
away all the way out to Bethesda. Is it realistic? Will 
Klausner pay any attention to the subordinate of the Secretary?
    Dr. Sullivan. I think so if that person has, indeed, 
reporting authority and dollars to implement the program. 
Certainly having the interest and support and the leadership of 
the Secretary helps significantly, but you clearly must have an 
organization that is responsive to these concerns.
    Senator Specter. How effective can the Secretary be in 
affecting Dr. Varmus, Dr. Sullivan?
    Who was the NIH Director when you were there?
    Dr. Sullivan. Dr. Healy, Bernadine Healy.
    Senator Specter. How effective were you in affecting Dr. 
Healy?
    Dr. Sullivan. Very effective. Dr. Healy and I worked very 
well together, and she was the individual who implemented the 
Office of Research and Minority Health and helped to establish 
the budget for that office.
    Senator Specter. She just made one mistake in her career: 
She was not elected to the Senate. [Laughter.]
    Dr. Sullivan. Right.
    Senator Specter. So far.
    Dr. Sullivan. So far.
    Senator Specter. How about it, Dr. Klausner? Will you pay 
attention to the subordinate in HHS who puts a long arm across 
all those miles out there and says----
    Dr. Klausner. Yes, we do very much. We actually do not feel 
that they are very long arms. They seem to be right there.
    Senator Specter. And spend more money on minorities?
    Dr. Klausner. I feel that that office has been working. It 
is not really for me to defend Dr. Ruffin's office.
    But my sense is what has clearly happened--and it is not 
hard to demonstrate and I think the committee saw it--is that 
there has been a change of culture at the NIH over the last 10 
years. There certainly has been a change of culture at NCI.
    Senator Specter. Dr. Sullivan, a two-part question. Has 
there been a change of culture, and if so, for the better?
    Dr. Sullivan. There has been a change of culture for the 
better, but not enough change. These issues, Mr. Chairman, we 
are talking about today and from the IOM report are not new. 
These were issues that, before I came to Washington, we were 
discussing with officials at NIH.
    And I would agree with Dr. Weinberg. I think the question 
as to whether or not it is $24 million or $124 million--it is 
not enough, even the $124 million, being generous using NIH's 
own figures.
    Senator Specter. Dr. Weinberg, how much is enough? How high 
is up?
    Dr. Weinberg. Well, I think the way I would answer that is 
within the context of what has been proposed, for the institute 
to address the issues on cancer, we believe there is room in 
the budget that has been proposed to address the issue. It is 
an allocation issue, and much of it is dependent upon how we 
define special populations as we talked about before.
    Dr. Klausner showed me an abstract before this session that 
I would agree has relevance to the issues that we are talking 
about today that was excluded from the count. On the other 
hand, there are many things which are probably in the account--
for example, from the Office of Minority Health and Research, 
there is $1.7 million of their total $6 million that was 
counted in the $24 million, if I have got the numbers correct, 
that went to a pediatric HIV treatment program, which does not 
necessarily fit the bill.
    Senator Specter. How much, Dr. Weinberg? I have got my pen 
poised. How much? [Laughter.]
    We have to write figures down.
    Dr. Weinberg. I am sorry. I frankly was not prepared to 
come with an actual number because I do not think we have the 
data to describe the answer to that question. That is why this 
dialogue between us is very important.
    Senator Specter. Well, if you do not know, how am I 
supposed to know?
    Dr. Weinberg. You are supposed to know, I guess, by helping 
us direct the agency to take this question and work with the 
community to answer the question of how do you define special 
populations and the issues, how do you then identify what is 
relevant research. Include us in that.
    Senator Specter. It is now 10:30 and we are going to have 
to conclude, but would you give this further study?
    Dr. Weinberg. Yes, I would.
    Senator Specter. Would you focus on the materials you need 
and give me a figure?
    Dr. Sullivan, would you give me a brief memorandum that I 
can take up with Secretary Shalala? This is a matter really of 
internal oversight so you have somebody who is really focusing 
on minority issues. Dr. Klausner is very much concerned about 
it, and I am confident of that, but he has got a lot of other 
fish to fry and a lot of other directions.
    Dr. Sullivan. I would be happy, Mr. Chairman.
    Senator Specter. So, perhaps we can put something in our 
bill or in our report which would be specific standards as to 
what you think ought to be done because you have had the 
experience both in Government and out of Government.
    Dr. Weinberg, you questioned the figure. Tell me what you 
think the figure ought to be and why.
    Dr. Klausner will be back a lot of times.

                         conclusion of hearing

    Thank you all very much for being here, that concludes our 
hearing. The subcommittee will stand in recess subject to the 
call of the Chair.
    [Whereupon, at 10:30 a.m., Thursday, January 21, the 
hearing was concluded, and the subcommittee was recessed, to 
reconvene subject to the call of the Chair.]

                                  
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