[Senate Hearing 106-91]
[From the U.S. Government Publishing Office]
S. Hrg. 106-91
CANCER RESEARCH IN MINORITY AND
MEDICALLY UNDERSERVED POPULATIONS
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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
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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
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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
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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.]