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STATEMENT OF DR. GAIL H. CASSELL

Mr. Chairman and Members of the Subcommittee, my name is Gail Cassell and I am Chairman of the Committee on Medical Microbiology and Immunology of the Public and Scientific Affairs Board (PSAB) of the American Society for Microbiology (ASM). I am also Professor and Chairman of Microbiology at the University of Alabama, Birmingham. The ASM is the largest single biological life science society in the world with an active membership of over 38,000. On behalf of the ASM. I wish to thank the Chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies for the opportunity to express the views of the ASM on the fiscal year (FY) 1992 budget for the National Institutes of Health (NIH).

Biomedical research is an Incredible story of success due in large part to the foresight and generosity of this Subcommittee and Congress. Major medical advances made since 1950 have included vaccines against polio, rubella, measles, hepatitis and the discovery of molecular biology and recombinant DNA technology. No doubt every American is the beneficiary of these and many other scientific achievements.

But the war against human disease is not over, and it must continue to be waged with substantial and sustained investments in federal support for biomedical research. Many batties lie ahead, and both progress and victories will depend on strong federal Investment in our nation's scientists to acquire new knowledge and greater understanding of disease processes.

The quantity and particularly the quality of individuals being drawn to biomedical research careers are both decreasing at a time when the knowledge base, new questions, new diseases, and international competitors are all increasing dramatically. It seems clear that young Americans are reluctant to commit themselves to a career with such limited opportunities, regardless of their personal interests. Who could blame them? Foreign graduate students are beginning to dominale at many U.S. institutions, much like the situation that has existed for many years in graduate engineering schools. This country cannot afford to let this happen.

Admittedly, the National Institutes of Health has received favorable treatment in this time of fiscal austerity. Ho:vever, the research opportunities have never been greater or more costly, creating the need for increased spending. The opportunities that exist in science today to improve human health far exceed what the funds requested for NIH for FY 1992 will permit.

Research Project Grants Suppon

Individual research project grants are the single most important mechanism to achieve continued scientific progress, and we are grateful that Congress included additional funding and a commitment in the FY 1991 appropriations bill to support a goal of 6,000 new and competing grants in e n of the next 4 years, reaching a total of 24,000 research project grants. We appreciate this ch ar indication li Congress strongly supports growth in the biomedical research enterprise. Continued real growth in the NIH budget will be necessary to maintain the momentum, competitiveness and vitality of the biomedical research endeavor and to build on knowledge gained by the nation's investments in research.

The instability in funding research grants in recent years has been demoralizing to many scientists and discouraging to students considering a career in biomedical research. A substantial number of high quality grant applications that span the research continuum from basic research to clinical investigation continue to go unfunded. It is noteworthy that investigators who are at the highest risk of having their grant applications unfunded are those undertaking new and innovative approaches and those vi ose research has not yet had the opportunity to attain maturity. At an expected 22%-26% rate of funding, mai excellent projects will not receive essential support.

While NIH's budget has grown despite overall government spending austerity, the increases have not kept pace with the real costs of research and the expansion of our research capacity. The extraordinary advances that have been made in understanding biology mean that more complex and costlier scientific problems must be undertaken creating demands for new resources. The growth in the annualized average cost of a research project grant (in constant dollars) has been only 1.7% since 1980, a rather low figure considering the growth in the scientific, technological as well as regulatory complexity of research. During the past few years, more than 23 additional administrative regulations have been imposed including tighter regulations on the performance of chemical hoods and costs of new facilities. A consequence of these new regulations is to increase research costs and to decrease funds devoted directly to laboratory research. It is estimated to cost $537 million to comply with the new animal welfare rules and research facilities will incur about 87% of the total cost. Although the Biomedical Research Deflator Price Index (BADPI) (5.7%) may be considered a reasonable measure of the effects of inflation on the costs of personnel and supplies, as research becomes more complex, the BADPI máy not reflect the true costs of research.

We concur with Congress that NIH should carefully examine its financial management to ensure that the most effective use is made of limited resources. Although there is need for thoughtful, sound planning to provide for sustainable growth in the NIH budget, careful assessment is needed of changes proposed to restrict the yearto-year growth of the costs of grants. Under the proposed plan, for example, the size of grants funded in 1991, both competing and noncompeting, will be reduced substantially from study-section recommended levels to hold cost increases in line with the BRDPI. Funding is also not sufficient in the FY 1991 appropriation to fund 6,000 grants and awards must be reduced to fund 5,785 new and competing grants this year.

Recommendation for NIH FY 1992 Budget of $9.7 Billion

The ASM joins with the Ad Hoc Group for Medical Research Funding in recommending a budget of $9.7 billion for NIH in fiscal 1992. The Ad Hoc Group's proposal would provide funding for approximately one-third of reviewed research proposals at levels of funding recommended by study sections. The Ad Hoc Group's budget recommends historic levels of the average costs of grants as determined by study sections. The Ad Hoc Group's recommendation will allow for balanced support of research. While we all agree that RO1s are of the utmost importance to the research initiative, without adequate funding of clinical research centers, clinical trials and multidisciplinary research provided by program projects, basic information generated by Rois cannot be efficiently transferred to the bedside and to industry.

Scientific Opportunities

Many scientific opportunities can be identified to justify additional funding for NIH above the amount requested. For example, in our opinion, the National Institute of Allergy and Infectious Diseases (NIAID) could well utilize an increase of more than 30% over the President's FY 1992 request. Under the President's request, the number of new and competing research project grants awarded by the NIAID will fall well below last year and the Institute's success rate of 22% is among the lowest at NIH. An increase of 30% would help ensure that more research and training is done to control and prevent infectious and immunologic diseases. Greater investment could be made in basic biomedical research and in taking advantage of current research opportunities to meet the Secretary's public health goals to improve the effectiveness of current medical treatment, reduce infant mortality, serve special populations and prevent disease. Maternal infections currently thought to be a major cause of premature birth and consequently infant morbidity and mortality. Infections of the female reproductive and urinary tracts are major women's health problems which need immediate attention if we are to reduce this country's and indeed the world's infant death rate. With increased funding. NIAID would be able to provide funds for basic research and clinical trials to develop and test vaccines that are effective against sexually transmitted diseases, tuberculosis, and measles, all of which are major health problems for blacks and inner city residents. Additionally, they could expand their efforts in the development of additional therapeutic agents for HIV, non-HIV viral infections and opportunistic infections. Additional new funding could be used io fully support the Children's Vaccine Initiative which seeks to develop a vaccine that can provide immunologic response to seven or more common childhood diseases with one dose. This would go a long way towards reducing illness, acquired mental retardation, and death in our country, as well as in many third world countries.

The burden of illness and death from AIDS is intensifying. Knowledge to control the epidemic, to cure AIDS or to stop the disease in infected persons has not been acquired and progress in vaccine development depends on additional research. More support is needed for scientists studying how viruses produce disease and how the immune system works to protect against infections. We agree with the IOM recommendation that greater investments should be made in basic research in such areas as immunology, virology and molecular biology. We urge that increases for AIDS not come at the expense of funding for other NIH programs, however, because other biomedical research could be harmed, including research that contributes to our understanding of AIDS.

Investment in Research for the Future

The return on the investment in research is great. For example, statistics indicate that recent introduction of a newly modified vaccine against childhood meningitis will result in a total cost-savings in health care of more than $359 million per year while the funding for the research that led to the development of the vaccine totalled only $17.4 million (1988 dollars).

There is a close link between fundamental research in the life sciences and often immediate application of the results of research to biotechnology. The largest amount of federal support for biotechnology (83%) is provided by the NIH. One of the major advances in chemotherapy promises to be the ability to target drugs selectively to diseased cells. These advances have been made possible by basic research in microbiology and immunology. Diphtheria is one of the oldest infectious diseases known to man and one of the first to be controlled by vaccination, yet basic scientists have continued to study how the deadly toxin works and how it gets inside cells. Who would have guessed at the time that this knowledge would allow us to use the toxin as a mechanism for drug delivery in cancer patients. Likewise, a similar approach using cholera toxin may allow us to deliver a number of different vaccines by the oral route.

Gene therapy has the potential for treating many inherited as well as infectious diseases. This is possible due largely to the long-term investment made by this country in basic research in microbial genetics. In fact, much of biotechnology in agriculture and industry is a direct result of this biomedical research. There is no doubt that further exploitation of biotechnology will lead to much greater advances in medicine and Industry. However, many potential opportunities in biotechnology remain unrealized due to the lack of basic information in some critical areas. Although the U.S. held an early lead in the biotechnology revolution, today it faces stiff competition from Japan and Europe. Can we afford to let them surpass us?

Training and Infrastructure Needs

Training is a critically important priority for biomedical research. It is essential that a pipeline of highly trained researchers in the biomedical disciplines is available to sustain the nation's biomedical research enterprise. The ASM continues to support increases in funding for research training to meet the demand for new scientists in academia, to fulfill industrial needs and to provide adequate stipend levels for trainces. It is important to support this training not only through NII but also through the CID of the COC.

The ASM supports restoration of the Biomedical Research Support Grant (BRSG) program to its 1999 level of $55 million. Due to severe budget constraints. NIH has been forced to eliminate BRSG funding However, BRSG funding is increasingly important as a source of suppon for pilot studies and shared equipment BRSG funds are the prime source of support for new and innovative research ideas and meet short term, low cosi, non recurring research needs not met by research project grants. Research areas funded by the BRSG program include Alzheinier's disease, AIDS, AIDS-related diseases and women's health issues. Eighteen percent of new RO1s are obtained by scientists with previous BRSG support and 20% of new FIRST (R29) awards are obtained by investigators who had previous stan-up funds from the BRSG program. Lack of funding from the BRSG program seriously impairs recruitment of new facully, the start-up of new labs and interim support to researchers during funding lapses.

A substantial reduction has been proposed for the NIH Shared Instrumentation Grant (SIG) program, which is requested at $8.7 million, a decrease of $23.9 million from fiscal 1991. The number of awards will decrease from 142 in 1991 to 36 in 1992. This is the only federal program for biomedical and behavioral researchers to obtain state-of-the-art instruments in the $100.000 to $400,000 category. The SIG program is a competitive, peer reviewed grant program. In the last three years, the SIG program has received over 400 applications, compared to 269 in 1988 and 255 in 1987. Of the $115.6 million requested in 1990, only $32 5 million could actually be awarded to fund 144 awards. New melhodological approaches require equipment which becomes more expensive each year. In its 10 years of operation, the SIG program has experienced a strong, unabated response from the biomedical community. We urge that the SIG program be restored to its 1991 level.

Lastly, we are concerned that the Administration has proposed that $400 million of the NIH budget not be spent until after September 19, 1992, 12 days before the end of the fiscal year 1992 The consequences of this maneuver are not well understood but surely will lead to serious delays in research funding

Thank you for the opportunity to testify and I would be pleased to respond to any questions.

Senator ADAMS. Thank you. I am concerned about one item on the last page of your testimony which says:

Last, we are concerned that the administration has proposed that $400 million of the NIH budget not be spent until after September 19, 1992.

Which is 12 days before the end of the fiscal year. Now that looks to me like a maneuver.

Can you indicate to me what the problems are in trying to spend $400 million in the last 12 days, or is this not a problem?

Dr. CASSELL. I think that it is a problem in terms of spending it wisely and, in fact, the chaos that that could cause with regard to appropriating funds.

Senator ADAMS. Thank you very much. We appreciate your testimony. STATEMENT OF DR. DOMINICK P. PURPURA, PAST PRESIDENT, SOCI.

ETY FOR NEUROSCIENCE
Senator ADAMS. Our next witness is Dr. Dominick Purpura, the
Society for Neuroscience.

Doctor.
Dr. PURPURA. Thank you, Senator.

Mr. Chairman, I am Dominick P. Purpura, professor of neuroscience and dean of the Albert Einstein College of Medicine and past president of the Society for Neuroscience, and a member of the National Academy of Sciences and Institute of Medicine. I am here on behalf of the 18,000 members of the Society for Neuroscience who enthusiastically recommend professional judgment budgets for those National Institutes of Health and ADAMIA institutes that make significant contributions to neuroscience research and research training

In addition to the National Institute of Neurological Disorders and Stroke which dedicates the largest proportion of its budget to neuroscience research, the Society for Neuroscience recommends the professional judgment budgets for the National Institute of Child Health and Human Development, the Eye Institute, the Institutes on Aging, and on Deafness and Communicative Disorders, and the ADAMHA Institutes.

The Society for Neuroscience recognizes that neurological, special sensory, and mental disorders constitute a broad spectrum of human disabilities that include disorders of movement, cognition, memory, learning, communication, as well as addictive and self-destructive behaviors.

Understanding the basic neuroscience mechanisms subserving these normal and aberrant functions of the brain requires a magnitude of support that is well beyond the funding capabilities of any one institute. For this reason, the Society for Neuroscience representing the major scientific body responsible for implementing the mandate of the Congress for a “Decade of the Brain" respectfully requests that the professional judgment budgets noted in my written testimony be made part of the permanent record of this hearing

Senator ADAMS. Without objection, that will be the order.
Dr. PURPURA. Thank you, sir.

Neuroscientists appeal for the funds appropriate to their mission which is no less than the most important question of the cosmos, how the brain works in health and in disease. They also reaffirm the importance of investigator-initiated research projects which have always been the centerpiece of NIH and ADAMH, programs. Failure to insure that at least one-third to 40 percent of submitted RO-1 applications are fully funded will continue to erode opportunities for ameliorating or preventing the most debilitating and dehumanizing disorders of the human condition.

One of the greatest works of English literature begins with the 12-word sentence, “It was the best of times, it was the worst of times.” Neuroscientists hold that from the standpoint of brain research these are the best of times. They bear witness to new discoveries in molecular and cell neurobiology, molecular and population genetics, brain imaging, cognitive and computational neuroscience, and methods for modifying growth and regenerative processes of damaged brain and spinal cord systems.

Our success in meeting the challenge implicit in the presidential proclamation for a “Decade of the Brain,” our success is evident in the rapid growth of knowledge of basic processes underlying the function of the brain. I believe we are already halfway there in providing safe and effective agents for controlling epilepsy, restoring memory defects of Alzheimer's disease, halting the progressive deterioration of Parkinson's disease, and restoring functions after stroke and trauma and returning the mentally ill to productive lives, and preventing the craving for illicit drugs.

PREPARED STATEMENT

Halfway bridges to new knowledge lead to only one outcome, that these will be the worst of times, for failed opportunity is the bitter fruit of a noble purpose that has gone awry. The Society for Neuroscience pledges its continuing efforts to make these the best of times for 80 million Americans who suffer from neurological special sensory or mental disorders, and your support as in the past of neuroscience research programs identified in our professional judgment budgets for the NIH and ADAMHA and these institutes mentioned earlier will guarantee our success for the people of the United States.

Thank you.

[The statement follows:)

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