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BIOMEDICAL RESEARCH

Question. Dr. Raub, what was the original NIH budget request submitted to the Public Health Service for FY 1991 ? How does it compare with the request for the NIH in the President's budget? How much would be required to keep pace with the biomedical research inflator?

Answer. The original FY 1991 budget request submitted to the Public Health Service totaled $11,058.5 million. This amount is $3,128.8 million more than the President's budget request.

The estimated FY 1991 Biomedical Research and Development Price Index '(BRDPI) is 5.8 percent. If the BRDPI was applied to the FY 1990 budget, excluding funding for AIDS, the Human Genome Program, and B&F, since these programs have increased by a higher rate than the BRDPI, the FY 1991 estimate would be $7,103 million. This is an increase of approximately $170 million over the budget request. When you add back funding for AIDS, the Human Genome Program, and B&F, the total estimate is $8,100 million.

CHANGES IN EASTERN EUROPE

Question. Dr. Raub, what impact, if any, will the recent changes in Eastern Europe and the Soviet Union have on the National Institutes of Health activities in the coming fiscal year? What opportunities do these events afford for improving the stability and quality of life in both the United States and these nations? Does the President's budget for fiscal year 1991 include additional funds for expanded outreach and collaboration with the biomedical research scientists in Eastern Bloc nations?

Answer. Early indications show that several of the Institutes, Centers and Divisions of NIH will attempt to expand their collaboration with East European and Soviet scientists in light of recent political changes. We also expect Eastern European scientists to participate more fully in the ongoing Fogarty International Centeradministered scientist exchange programs. The President's budget for FY 1991 for the Fogarty International Center includes an additional $50,000 targeted for expanded collaboration with East European and Soviet biomedical research scientists.

Some research opportunities the NIH has identified include the following

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Research on Cardiovascular and Pulmonary Disease --while cardiovascular disease has declined by 35% during the last two decades in the U.S., it has risen by 60% in Poland. Hungary has the highest rates in the world for bronchitis, emphysema and asthma.

o U.S. and Czechoslovakian scientists have proposed research on

ischemic heart disease and other pulmonary and blood disorders; U.S. and Romanian scientists have prepared symposia on similar subject areas.

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NIH scientists are interested in studying the health effects of toxic chemicals and other environmental pollutants and in

assisting researchers in Eastern-Europe to monitor dangerous chemical levels.

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Lyme Disease is of special interest to U.S. researchers because the tick species responsible for its transmission in Europe is different from the U.S. species. Dermatological and neurological complications seem to be more common in Europe and insights into the natural progression of the disease could be forthcoming from cooperative research.

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AIDS research is a priority throughout eastern Europe. HIV infection rates and demographics that differ from the U.S. experience have prompted considerable interest. The problem of pediatric AIDS is particularly acute in Romania.

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U.S. scientists are eager to expand ongoing collaboration with the Institute for Mother and Child in Poland.

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In the Cancer area, the Soviets are interested in establishing cancer centers based on the U.S. model. We are supportive of this effort and of sharing cancer data with Soviet medical practitioners and scientists.

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Dental research, brain function research, neurobiology,
biomedical engineering, genetic research and mathematical
modeling are also areas where mutual interests have been
expressed.

In order to take advantage of these and other research opportunities in the region, the Fogarty International Center has developed a proposal for an Eastern European Initiative, which could also be expanded to include the Soviet Union. The Initiative, for which funds are not included in the FY 1991 budget request; would provide the following:

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Research grants for U.S. scientists to conduct collaborative
research with Eastern European scientists (26 grants at $50,000
each for a total of $1,300,000). American scientists who
already have research grant support from NIH will be invited to
apply for these grants through the regular NIH grants review
process. These grants will cover additional costs of
conducting research in the American scientist's laboratory in
cooperation with an Eastern European scientist and will provide
for supplies and equipment needed by the Eastern European
scientific collaborators (most of which would be purchased in
the West). These grants would also pay for scientific
exchanges so that the investigators in both countries can work
together. Topics covered by these research grants would
include cancer, cardiovascular disease, influenza and virus
diseases, neurological disorders, environmental health, aging,
and other scientific areas of high mutual priority.

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Training grants in U.S. institutions for Eastern European scientists and health professionals involved in the scientific and medical aspects of AIDS (20 trainees at $30,000 each for a total of $600,000). These grants would supplement existing international AIDS training grants already awarded by the Fogarty International Center to ten U.S. universities.

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Research fellowships to support Eastern European scientists in
U.S. biomedical research laboratories (40 fellowships at
$30,000 each for a total of $2,300,000). These fellowships
would be offered through the Fogarty International Center's
International Research Fellowship Program which supports young
scientists for one to two years for training. These additional
funds would enable FIC to respond to requests from Bulgaria and
Czechoslovakia and would expand the program in other Eastern
European countries.

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Short-term exchange research consultations between U.S. and
Eastern European scientists (50 exchange visits at a cost of
$8,000. each for a total of $400,000). The travel and per diem
for Eastern European and American scientists to undertake
collaborative research consultations in each other's countries
for periods of up to six months.

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Scientific workshops (10 workshops at a cost of $50,000 each
for a total of $500,000). These funds would support technical
workshops or conferences designed to bring together individuals
with common scientific interests to exchange information,
develop linkages and define areas of promising scientific
collaboration between scientists and institutions in both
countries.

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NATIONAL CANCER INSTITUTE

STATEMENT OF DR. SAMUEL BRODER, DIRECTOR

BUDGET REQUEST
Senator HARKIN. We now want to call up our panels.

We will start first the panel with Dr. Samuel Broder, Director of the National Cancer Institute; Dr. Claude Lenfant, Director of the Heart, Lung, and Blood Institute; Dr. Harald Löe, Director of the National Institute of Dental Research; Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, and Associate Director for HIV Research at NIH.

And we will go in the order in which I called, and not necessarily in any order of importance or priority, but this is the way my book is organized. So we will start with the National Cancer Institute.

Dr. Broder, we are glad to have you with us this morning. Your budget request is for $1.694 billion, an increase of almost $60 million over last year, and a growth rate of approximately 3.7 percent.

I also notice you intend to continue support for the 56 research centers, and your total number of research grants would be 3,109, a reduction of 10 grants from 1990.

Dr. Broder, if you would proceed with a brief statement, and then what we will do is we will take each Institute and then we will come back for general questioning for everyone.

PREPARED STATEMENT

Your statements will all be made a part of the record in their entirety. I read them over the weekend and I would just ask you to please proceed and either summarize or highlight what you want us to focus on. [The statement follows:]

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STATEMENT OF DR. SAMUEL BRODER

One million Americans will learn this year that they have cancer and about half of them will eventually die of cancer. Our best response to the challenge of cancer - a disease which causes suffering beyond metaphor must be an intense effort to generate knowledge and to apply it quickly. The three foundation stones of the NCI are: basic research, clinical trials in prevention and therapy, and the cancer centers. The results of NCI's research belong to all Americans regardless of their race, age, Incone, social status, or place of residence.

Cancer research and technology transfer require creative, highly trained scientists and clinicians and well equipped laboratories. Other resources are needed, such as a network of cancer centers, each bringing interdisciplinary approaches to cancer in its community, as well as addressing national and regional problems. An array of organized clinical trials is needed to generate knowledge regarding new drugs, preventions, and therapies. A vigorous program of clinical trials must involve academic centers and community physicians.

Among other achievements, two NCI scientists (together with a colleague from the National Heart, Lung, and Blood Institute) nade medical history last Spring by inserting new genetic material into human cells, returning the cells back to the patient, and then tracking the gene-engineered cells in the patient's circulatory system two months later. These experiments will lead to gene therapies and are based upon NCI basic research accomplishments.

Recently, NCI - supported scientists have made a number of important molecular discoveries, including: the location of molecular abnormalities believed to contribute to lung, colon and breast cancer by a loss of a critical regulatory mechanism; the location of the gene responsible for familial malignant melanoma on; identification of five proteins, implicated in the process of metastasis (the wild spread of cancer). Such discoveries pave the way for future research on prevention and cure of cancer.

For over 50 years, scientists have sought the cause of cystic fibrosis, and recently NCI - supported scientists discovered that the cystic fibrosis gene was 11nked to an oncogene (called met) thus providing a marker, which greatly facilitated the recent discovery and cloning of the cystic fibrosis gene.

NCI - supported clinical trials have shown that in some cancers, adjuvant treatment after surgery can reach remaining aicroscopic tumors, prevent tumor recurrence, and prolong or save lives. Last year adjuvant treatment using a combination of levamisole and 5-Fluorouracil, after surgery in Dukes' C colon cancer, an advanced cancer, made an improvement in 5-year survival rate, reducing deaths by a third. There will be approximately 110,000 new cases of colon cancer in 1990, of which 21,000 will be classed as Dukes' C stage.

Neoadjuvant therapy, that is using chemotherapy or radiotherapy before surgery, may shrink certain cancers and make it possible to llait surgery, permitting the salvage of structures 11ke the bladder, rectum or breast which would otherwise have been sacrificed to stop the cancer.

Clinical trials often take years to complete. Now, in addition to large clinical cooperative groups, NCI is using the mass media to draw attention to clinical trials. Accelerated enrollment speeds evaluation of new therapies and brings state-of-the-art therapies to more people.

NCI has a long commitment to cancer prevention. Chemoprevention studies are being carried out in breast, lung, colon, bladder, and skin cancers with agents related to the retinoids, beta-carotene, vitanin E, selenium, and other substances. A recent study showed that a high wheat fiber diet decreased the number of large bowel polyps -- cancer precursors. This study vas conducted in patients at high risk for large bowel cancer, but this diet nay reduce the risk of bowel cancer among all Americans.

Sometimes research affects us right in our own backyards; NCI - supported scientists have studied and identified the mutagenic substances forned when

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