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LETTER FROM DR. THOMAS S. EDGINGTON

May 13, 1991. Hon. BROCK ADAMS, U.S. Senate, Washington, DC.

DEAR SENATOR ADAMS: At the April 17, 1991 hearing of the Senate Labor-HHSEducation Appropriations Subcommittee, at which I testified on behalf of FASEB, you requested a prioritized list of the biomedical research commitments for the fiscal 1992 appropriations. The Federation's funding priorities for fiscal year 1992 specifically address the National Institutes of Health but can be applied comparably to ADAMHA and are as follows:

One, to overcome current very serious under-investment in biomedical research, NIH really will require sufficient appropriations to fund 30 percent of eligible applications for investigator-initiated research project grants. For fiscal 1997, the Federation recommends support of 6,143 new and competing grants. This is considered a minimum number for responsibly enabling research necessary for solution of the disease challenges of the nation and eventual cost reduction through effective cure.

Two, FASEB recommends full funding of new and competing grants and noncompeting continuations at the peer-review approved levels starting in fiscal year 1992. This will require a one-time increase to compensate for the damaging effects of NIH cost containment measures taken in fiscal year 1991 and downward negotiations” in preceding years. As an alternative, a three-year stepped correction of underfunding could be considered.

Three, NIH should support the numbers of predoctoral and postdoctoral trainees recommended by the National Academy of Sciences. Trainee stipends should be increased in fiscal year 1992 to reflect levels of experience and be adjusted for inflation thereafter. Other training improvements cited in FASEB’s testimony should also be adopted.

Four, other elements of the NIH budget, containing an agenda of related interests, should be increased at least by the current biomedical inflation factor, or greater, depending on specific justifications.

The total budget recommended for NIH for fiscal year 1992 is $9.7 billion. Comparable actions should be applied to the Alcohol, Drug Abuse and Mental Health Administration.

I trust this summary of FASEB's priorities for fiscal year 1992 NIHADAMHA funding will be helpful to you and the Labor-HHS Subcommittee. Please contact me through FASEB if I may provide you with any additional information. Sincerely,

THOMAS S. EDGINGTON, MD,

President. Senator ADAMS. Senator Gorton. Senator GORTON. No questions, Mr. Chairman. Thank you very much, Doctor. Your testimony was excellent. Dr. EDGINGTON. Thank you very much.

Senator GORTON. We are sad for you, for your problem, and for the Nation,

Dr. EDGINGTON. Thank you. STATEMENT OF DR. RICHARD G. LYNCH, UNIVERSITY OF IOWA COL

LEGE OF MEDICINE, AMERICAN ASSOCIATION OF IMMUNOL

OGISTS Senator ADAMS. The next witness is Dr. Richard Lynch, University of Iowa College of Medicine, the American Association of Immunologists.

Doctor.

Dr. LYNCH. Mr. Chairman, ladies and gentlemen, I want to thank you for the opportunity to testify before this Senate subcommittee. I represent more than 5,000 members of the American Association of Immunologists. Our membership includes both basic scientists and clinicians who conduct research in the field of immunology.

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The immune system is our major defense against infectious diseases and is a unique organ system in humans because it is a mobile system whose elements circulate throughout the entire body. Because of this mobile feature, the immune system is involved in the health and disease of all the other organ systems of the body.

In addition to infectious diseases, research and immunology is improving our understanding and ability to manage such important diseases as diabetes, asthma, and other allergic disorders, cancer, leukemia, kidney disease, and a host of other important disease processes.

Advances from basic research and immunology are beginning to impact in the field of dentistry and on diseases of the joints and skeleton which are important to health problems, especially in our senior citizens. You have our written statement and ommendations, but in the time allotted I want to emphasize a few points.

First, I want to acknowledge the congressional recommendation to fund some 6,000 new grants in fiscal year 1991 and 24,000 peer review grants by the National Institutes of Health by fiscal year 1994. Our association expresses our thanks to Members of Congress and especially this subcommittee for insuring continued support for biomedical research, since these grants provide the resources for carrying out this important work.

A vital element for the continued and future success of this Nation's biomedical research effort is the training of our next generation of academicians and of the scientists who will guide the further development of the biotechnology industry in this country: Achieving stability of research funding will insure that our talented young people will pursue careers in biomedical science.

The biotechnology industry has emerged in the United States as one of the most important present and future forces in the Nation's economy. Although this industry is still young, it has already produced extraordinary products for the treatment of human disease. One of these products, alpha interferon, cures a form of leukemia. Another product accelerates the recovery of bone marrow cells after chemotherapy and radiation. Other products are routinely used to detect tumor cells and reduce or prevent rejection of kidney transplant.

PREPARED STATEMENT

This new technology which has its origins in basic research will transform the practice of medicine much as it did the development of antibiotics. Continued congressional commitment to the support of biomedical research and the training of scientists will benefit the health of our citizens and will insure that our Nation maintains its position as the world's leader in biotechnology. Our association believes that the Nation's interests will be well served if we continue to maintain a worldwide leader position in biotechnology.

I want to thank you for the opportunity to testify. You have the specific recommendations in the written statement.

(The statement follows:]

STATEMENT OF RICHARD G. LYNCH Mr. Chairman, Ladies and gentlemen: I am Richard G. Lynch and I thank you for the opportunity to testify before the Senate Appropriations Subcommittee on Labor, HAS, Education and Related Agencies. I represent more than 5,000 members of the American Association of Immunologists (AAI). The members of the AAI include both basic scientists and clinicians who conduct research on major immunologic diseases, regulation of the immune system in health and disease, transplantation and tumor biology, and organ specific disorders such as diabetes and inflammatory diseases of the skin, gastrointestinal tract, eye and brain.

I would like to begin this testimony by acknowledging the Congressional recommendation to fund some 6,000 new grants in fiscal year 1991 and 24,000 peerreviewed grants by the National Institutes of Health by fiscal year 1994. Members of our society greatly appreciate this expression of your confidence. We further wish to thank Members of the Congress, and especially this Subcommittee, for ensuring continued support for biomedical research since these grants are the very lifeblood of our scientific endeavor.

Grants fund basic and clinical research in universities, medical schools, hospitals, clinics, research institutes and, to a limited extent, in the laboratories of the biotechnology industry. Grant funds pay part of the salaries of senior and junior investigators, postdoctoral fellows, technicians and laboratory assistants. The two major accomplishments of the grant funding mechanism are: (1) important new knowledge is gained that directly enhances our understanding of the cause, cure, and prevention of human disease; and (2) new scientists are trained to enter the field and fur. ther expand the scientific knowledge base. We would especially like to emphasize this latter point, because the attractiveness of a career in biomedical science for potential young investigators is critical to maintaining the preeminence of the biomedical science enterprise in the United States as well as the biotechnology industry. In a recent survey of the members of the AAI, over 90 percent concluded that they would not recommend the same career track to junior faculty members and graduate students, primarily because of the current funding climate in basic research.

A key issue we are now confronting in the universities and medical schools is where our next generation of academicians, engaged in basic and/or clinical research, will come from. NIH-awarded grants to junior investigators are vital, since they provide these talented young people with the opportunity to initiate and conduct research in laboratories within the university setting. This is the primary training mechanism for biomedical scientists for academe and for the biotechnology industry.

The biotechnology industry has emerged in the United States over the past decade as one of the most important present and future forces in the nation's economy. Although this industry is still “young," it has already produced such extraordinary products for the treatment of human disease as alpha interferon, which cures a form of leukemia; GM-CSF or the granulocyte-macrophage colony stimulating factor, which accelerates the recovery of bone marrow cells after chemotherapy and radiation; and monoclonal antibodies, which identify tumor cells or which can reduce or prevent rejection of kidney transplants. Even more promising and exciting products are now being prepared for clinical trials. The potential, and the likelihood, that the technology evolving from basic research will transform the practice of medicine is very great.

Although many of the biomedical sciences have contributed to the extraordinary development of the biotechnology industry, the field of immunology has clearly played a central role. The AAI feels particularly compelled therefore to emphasize how important it is to provide continuing support for basic research and training in immunology, as well as in all of the biomedical disciplines represented within the NIH.

Leaders of the biotechnology industry strongly support this view because they fully recognize and acknowledge that support for basic research, especially though NIH, has made it possible for this industry to emerge in the United States. Chief Executive Officers of major biotechnology firms have stated that the industry is heavily, reliant upon the fundamental process by which NIH provides grant support for individual investigators who in turn discover new_molecules and cellular processes that represent potential products of the future. The biotechnology industry itself is unable now, or in the foreseeable future, to provide this type of support in sufficient magnitude. These firms must focus their activities primarily on a few products that can be brought to the marketplace. They cannot afford to explore many different avenues of research, and yet they must be poised to capitalize on new discoveries that fit into the individual company's strategy. Therefore, the basic biomedical research enterprise must rely upon the federal government, and especially the NIH, for its support.

We have emphasized the extraordinary health and welfare benefits to citizens of the United States from the development of the biotechnology industry. But we are also mindful of the increasingly important economic impact and potential of the biotechnology industry in the United States and in the world. At present, basic biomedical and clinical research in the U.S. are preeminent in the world. It is no accident that the U.S. biotechnology industry also leads the world at the present time. As this industry grows in economic power and insluence during the next and subsequent decades, it is critically important that the U.S. be able to retain and, in fact, increase this premier economic position. Only by continued support for basic biomedical research, especially through NIH, will this be possible. This will insure the continued acquisition of new knowledge, and most importantly, the ability of the academic community to train the next generation of scientists. It is this group of individuals that will conduct the basic research of the future, and will provide the work force for research and development that is the liseblood of the biotechnology industry.

The AAI would like to emphasize to this Subcommittee that even at the current level of NIH grant support, a large number of high quality grant proposals are not being funded, and opportunities for research in important new areas are being lost. This is especially true in immunology with respect to some key areas where our society faces extraordinary challenges now and in the near future. For example, we need to design and develop much more efficacious vaccines against infections such as fly and pneumonia so that we can prevent these diseases that are still deadly to vulnerabie populations such as the elderly.

Also, deterioration in our environment is generally recognized as a major problem that will progressively affect the quality of our work and lives, but very little is known about the impact of chronic environmental toxins on the immune systems of humans or animals. Evidence suggests that chronic exposure to environmental toxins in fresh and salt waters, such as our coastal reefs and estuaries, impairs the immune systems of fish and other aquatic creatures, leading to death from infections and tumors. The economic impact alone of this outcome will be enormous, not to mention its potential as an ecologic disaster. Furthermore, we need to understand the short and long term consequences of thinning of the ozone layer and increased ultraviolet radiation on skin diseases, such as malignant melanoma.

At this critical time, a greater investment in basic immunologic research is needed, not only to exploit the opportunities mentioned above, but to meet the extraordinary challenges which our society faces now and in the near future.

We strongly urge that Congress write into the fiscal year 1992 budget sufficient funds to enable NIH to support 24,000 peer-reviewed grants by fiscal year 1994. And, we ask this Subcommittee to consider the concerns we have raised relevant to the future vitality of the basic research community and its role in development of the U.S. biotechnology industry. We foresee the need, in the very near future, for an expanded federal commitment to support basic research and especially training. Such a commitment is essential to the health of our nation, and to the competitive edge of the U.S. biotechnology industry, and therefore our economy.

IMMUNE SYSTEM

Senator ADAMS. Thank you, Dr. Lynch, for an excellent statement.

Senator Gorton, do you have any questions before you have to leave?

Senator GORTON. No.

Senator ADAMS. I would appreciate your submitting to the committee in written form your recommendations, again, on prioritization of grants.

With the immune system, as we well know, we were able to obtain additional funding last time for the problems that we deal with in AIDS. We realize that this is one part of a gigantic field for you. So we are going to try very hard on this subcommittee to prioritize our limited amount of money into the areas that all of you as experts feel are most important.

Just as I said to the prior witness, I would appreciate your submitting that in writing to us unless you have something you wish to state right at this moment.

Dr. LYNCH. We would be happy to give you our best recommendations and advice in writing about that. STATEMENT OF DR. MARTIN FRANK, AMERICAN PHYSIOLOGICAL SO

CIETY Senator ADAMS. Our next witness is Dr. Martin Frank, the American Physiological Society.

Dr. Frank, welcome to the committee.

Dr. FRANK. Mr. Chairman, thank you. My name is Martin Frank, and I am the executive director of the American Physiological Society. The society is pleased to have this opportunity to share with the subcommittee the society's views of the needs of the biomedical research community. The National Institutes of Health has provided the knowledge base for the treatment, cure, and prevention of diseases which afflicted humans for generations.

However, many other illnesses continue to cripple and infirm the citizenry. The unraveling of the genetic code and the consequent dramatic developments in molecular biology, all funded by NIH, marked a revolutionary advance in our understanding of biological phenomena. As more is learned about molecular details of cellular events, it becomes increasingly clear that such information needs to be integrated into cellular, tissue, and organ functions.

Universities and pharmaceutical companies are unable to find adequate numbers of scientists trained to perform integrated studies on intact organisms. Without physiologists, pathologists, and clinical investigators, the new molecules discovered by the molecular biologist cannot be related to overall body functions.

The American Physiological Society urges the Congress to continue its support of research efforts to unravel the mysteries of life and conquer the diseases that shorten it. The society urges the Congress to assure that investigator research project grants are expanded by funding at least 30

percent of the eligible applications in each of the next 5 years.

The society urges the Congress to provide funding for training that permits NIH and ADAMHA to support at least 12,555 preand post-doctoral trainees in fiscal year 1992 as recommended by the National Academy of Sciences. The availability of positions and competitive stipends and salaries are key to bringing young scientists into biomedical research.

In closing, the American Physiological Society wishes to remind the Congress that solving the mysteries of life and disease requires a broad multidisciplinary talent base. It is, therefore, imperative that training programs be included in the appropriations bill to develop the pool of investigators who can translate discoveries at the molecular level to cellular and organ physiology and interclinical application.

There is an ever-growing need for a cadre of scientists who understand how physiological functions are regulated at all levels from molecular to man. The future of America's preeminence in biomedical science is in serious jeopardy. It is most urgent that the Congress take the actions necessary to stop the perilous trend that

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