DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 1991 TUESDAY, FEBRUARY 20, 1990 U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC. The subcommittee met, at 10 a.m., in room SD-138, Dirksen Senate Office Building, Hon. Tom Harkin (chairman) presiding. Present: Senators Harkin, Bumpers, and Specter. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH STATEMENT OF WILLIAM F. RAUB, ACTING DIRECTOR ACCOMPANIED BY: KATHERINE L. BICK, DEPUTY DIRECTOR FOR EXTRAMURAL RESEARCH JOHN D. MAHONEY, ASSOCIATE DIRECTOR FOR ADMINISTRATION NORMAN D. MANSFIELD, ASSOCIATE DIRECTOR FOR RESEARCH SERVICES LEAMON M. LEE, DIRECTOR, DIVISION OF FINANCIAL MANAGEMENT ANTHONY S. FAUCI, ASSOCIATE DIRECTOR FOR AIDS RESEARCH DENNIS WILLIAMS, OFFICE OF THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES BUDGET REQUEST Senator HARKIN. Good morning. The Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will come to order. This morning and in our session this afternoon the committee will consider the fiscal year 1991 budget request to the National Institutes of Health of $7.93 billion, which is $354 million or 4.7 percent over last year's level. I have been told the biomedical inflation rate is projected to be approximately 5.8 percent. In other words, the administration's budget request for ÑIH does not keep up with inflation. And I am sure this committee will want to make every effort to at least ensure that the NIH funding keeps pace with inflation-I say that at least at a minimum. This budget proposal does, however, include a number of features that do deserve support. I was pleased to see that the total number of research project grants of 20,439 and new grants totaling 5,095 were both increased in fiscal year 1991 over the levels that existed last year. Every meeting I have, Dr. Raub, with the biomedical research community includes a discussion of the declining percentages of the approved grants that are funded. I understand that the 1989 level was 29.4 percent. It is estimated to decrease to 24.2 percent in 1990. I was pleased to see in the budget request, however, that the estimated percentage of approved grants that will be funded in the President's budget would increase to 25 percent. We would all like to see a higher percentage of approved grants being funded each year. It is, therefore, good news to see the percentage move up in fiscal year 1991. I should note, however, that there appears to be a number of underlying factors completely within the control of NIH that resulted in the decline in the number of approved grants that are funded. One such factor-and some of these I want to cover in the questions and answers and you might want to address them in your statement-is the approval rate for grant applications. In 1989 NIH approved 95 percent of the grant proposals that were submitted. These approved grants were indicated to be meritorious and worthy of funding. That is in 1989, 95 percent. In fiscal year 1982 only 85 percent of the grant proposals submitted were approved. I would like to know why is this happening. As NIH chooses to approve an ever-increasing percentage of grants, it only follows that a smaller percentage will be funded. Another factor that contributed to the decline in the percentage of funded approved grants is that NIH lengthened the time period for grant funding. In 1989 the average length of the grant was 4.2 years. In 1981 it was 3.3 years. Again, I would like to know why this is also happening. Again, I am not necessarily quarreling with either one of these trends, but I just need to understand them. And I think members of the committee need to understand why this is happening. Needless to say, we could overcome these trends with large increases of funds every year and that may be your response. And each year we do try to provide additional funding. I would point out that the NIH budget has doubled since 1980, happening during a time when discretionary spending has essentially been flat in other programs under this subcommittee's jurisdiction. Since I entered Congress in 1974, the NIH budget has increased from $1.9 billion to $7.9 billion. So I think this indicates that Congress and the American people do have confidence and respect for the outstanding and important work of the National Institutes of Health. Today we will hear about the biomedical research challenges and opportunities that we face from all of the different Institutes' cen ters. And Dr. Raub, I would, in just closing my remarks, like to say a few words to you personally. Since last August when you were named the Acting Director of the National Institutes of Health, I have noticed the steady course and fine stewardship that you have provided in this interim period. I want you to know that I and all of my colleagues join me in expressing our appreciation to you for the fine leadership that you have provided during this interim period. Again, Dr. Raub, welcome to the subcommittee. And likewise I would like to welcome all of the Institute and Center Directors who I see are here. Again, we appreciate all of your fine work, and we look forward to hearing your statement either during this morning's session or this afternoon's session. At this point I would like to leave the record open for any opening statement or comments by Senator Specter and any other statements by members of the subcommittee. PREPARED STATEMENT Senator HARKIN. Dr. Raub, again, welcome and thank you for your fine work and your leadership at the National Institutes of Health. And please proceed as you so desire. Your complete statement will be included in the record. [The statement follows:] STATEMENT OF WILLIAM F. RAUB Mr. Chairman, it is my privilege to appear before you and your colleagues on the Subcommittee to present the President's fiscal year 1991 budget proposal for the National Institutes of Health. In my presentation I will describe some of the advances made during the past year, discuss briefly a few significant new programs, mention some current issues, and outline the key points of the fiscal year 1991 budget proposal. In subsequent testimony Directors of our constituent units will describe in detail a number of important accomplishments, but I will take the liberty now of citing briefly a few highlights. For example: -Last year, a team from the National Cancer Institute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI) transferred cells containing foreign genes into humans for the first time. This successful use of a tracer gene not only is the first application of a powerful new tool for research but also constitutes a major step toward gene therapy in humans. -Scientists at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) have determined the structure of the receptor, a protein on the surface of most cells and basal cells that plays a central role in allergic reactions. From this information the scientists have developed a tissue culture system that can be used to screen for a new class of drugs, possibly for the prevention of allergy attacks. —Grantees of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and of NHLBI have isolated the cystic fibrosis (CF) gene. This step enhances significantly the prospects for developing drugs that can be designed to correct the defect. -Polymerase chain reaction (PCR), a powerful new technique developed directly from basic research funded by NIH, is now used in many areas of research and service. It is expected to have a profound effect on the joint effort by the NIH and the Department of Energy (DOE) to map and sequence the genome of humans and other organisms. PCR is the cornerstone of a proposal to "translate" the information from various physical mapping methods into a common language known as sequence-tagged-sites (STS). These sites are short tracts of a unique DNA sequence that can be identified by PCR and that can act as landmarks on a physical map. During 1989 the NIH continued to lead the Federal Government's research efforts against AIDS through studies conducted by our intramural scientists, by grantees, and by contractors. Studies sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) have shown that the drug AZT can delay disease progression in HIV-infected persons with low counts of T4 cells whether they have AIDS symp toms or not. These studies indicate that an estimated 600,000 HIV-infected Americans with early or no symptoms of the disease could benefit from AZT treatment. Another study has shown that reduced dosages of AZT are effective and reduce side effects. The efficacy and toxicity of a promising new drug, dideoxyinosine (ddI), will soon be compared with AZT in a large study. The NIAID has established 18 AIDS treatment research programs based in the communities where people with AIDS live and receive their medical care. The program will reach increased numbers of persons with HIV infection, including those in population groups that have been underrepresented in AIDS studies. The accelerated pace and productivity of basic biomedical research, so characteristic of its recent history, continues unabated. There has been a marked shortening of the interval between new findings from basic studies and their widespread application in measures for improving the health of the American people. The NIH intramural program is recognized as a leader among government agencies in implementing the Technology Transfer Act of 1986, whose purpose is to facilitate the transfer of the results of federally supported research through development and then through widespread use. The NIH now has about 100 Čooperative Research and Development Agreements (CRADA's) with industry and about that many more in various stages of negotiation. Through the CRADA's, government and industry scientists can make optimum use of the resources unique to each party in their joint research efforts. The National Center for Biotechnology Information (NCBI), established at NIH in late 1988 within the National Library of Medicine, has begun to integrate existing data bases and is developing new computer programs to analyze them. Information access has become an urgent problem, not only for the human genome program, but also for the many facets of biotechnology. While we extend our efforts in technology transfer, we must ensure that research goals are not unduly influenced by conflicts of interest affecting the participants in research projects at awardee institutions. We seek balanced solutions that will protect the integrity of the supported research without imposing unnecessary restrictions on this creative enterprise. We also face concerns about dishonest practices in biomedical science. Misconduct in science is rare, but when it occurs it undermines the public's faith and can jeopardize subsequent research and even proper medical treatment. To monitor and investigate all misconduct in science cases in the Public Health Service-which includes any on the NIH campus or at awardee institutions-the Office of Scientific Integrity (OSI) was established within the Office of the Director, NIH. It currently is dealing with 72 active cases. The OSI will collaborate with the Office of Scientific Integrity Review (OSIR) that recently was established in the Office of the Assistant Secretary for Health. In another area of concern, I note with alarm the continuing attacks on biomedical science by advocates of animal rights. At a time when biomedical research is making such rapid progress and its benefits are ever more promising, it is tragic that animal “rights” activists continue to intensify their efforts to stifle important avenues of research through harassment of individual scientists and blatant terrorist acts of theft and property destruction. We at the NIH believe that the use of laboratory animals is a scientific necessity and, in fact, is an ethical imperative. We are greatly concerned about the humane care and use of animals and strongly be lieve that good animal care is an indispensable part of good science. Mr. Chairman, the fiscal year 1991 budget request for the NIH is $7,929.7 million, an increase of $353.3 million or 4.7 percent over the comparable fiscal year 1990 level. The requested increase includes an additional $56.6 million for the AIDS program and $48.5 million for the Human Genome Initiative. The budget request continues to reflect the priority the Administration places on the support of basic research, seeking an increase of 5.7 percent. In allocating the fiscal year 1991 request, NIH gave its highest priority to the support of improvements in its intramural facilities, whose needs have become critical in recent years. Of particular importance is continued support for ongoing modernization of the Warren Grant Magnuson Clinical Center, for renovation projects in our laboratory buildings and the upgrading of our animal facilities. Furthermore, the condition of NIH boilers, chillers, and steam lines has reached the critical point where the useful life of these vital facilities is ending. The NIH firmly believes that these needs must be addressed and has requested $88.6 million, an increase of $27.6 million over the 1990 funding level for the building and facilities fund. Investigator-initiated research continues to be a very high priority. Research project grants would be funded at a level of $4,425 million, an increase of 5.4 percent over the 1990 funding level. This amount will allow average cost increases of about 5.8 percent for noncompeting and 2 percent for competing awards. The fiscal year 1991 request would support a total of 20,439 research project grants, of which 5,095 would be competing research project grants, an increase of 462 competing awards over the fiscal year 1990 level. The NIH also continues to place a high priority on research training. The fiscal year 1991 request will support a total of 12,020 trainees, an increase of 225 over the fiscal year 1990 level. As a reflection of the importance NIH places on expanding the number of biomedical researchers who are ethnic minorities, the fiscal year 1991 budget requests that the Minority Access to Research Careers Program, the Minority Biomedical Research Support Program, the Minority High School Apprenticeship Program, and the Research Centers in Minority Institutions receive an overall 17 percent increase over fiscal year 1990. In fiscal year 1991 the Biomedical Research Support Grant Program will be funded at a level of $17.7 million. Consistent with the Secretary's minority health initiative, one-third of the 1991 funds will be awarded to institutions to increase support for underrepresented minorities or economically disadvanted students in science and engineering. The Intramural Research Program at NIH constitutes the nation's preeminent institution for the biomedical sciences. The request for intramural research of $914.9 million provides an increase for intramural research of 6.9 percent over the fiscal year 1990 base. This increase allows for continuing expansion in the AIDS program and will cover the costs of such administrative items as within-grade increases and the costs associated with January, 1990 and 1991 pay raises. The request also includes $20 million for the Director's Discretionary Fund. Although Congress did not support this fund in the fiscal year 1990 appropriations, NIH believes it is an important mechanism that will allow the NIH to be more responsive to emerging research opportunities. For the first time, a separate request is made for the recently established new National Center for Human Genome Research, and it proposes a significant increase, continuing the emphasis placed on this initiative by the Administration. A five-year plan to be released in the spring of 1990 establishes the scientific goals for the U.S. human genome project from 1991 to 1995. The fiscal year 1991 request for the Center is $108 million, an increase of $48.5 million over the comparable fiscal year 1990 estimate. The successful completion of this project holds great promise for future advances in health research. I would be pleased to respond to any questions you may have. INTRODUCTION OF ASSOCIATES Dr. RAUB. Thank you very much, Senator Harkin. My colleagues and I appreciate your support and, as always, are pleased to have this opportunity to tell you about our programs. With me at the table today are Mr. Norman Mansfield, Associate Director for Research Services; Dr. Katherine Bick, Deputy Director for Extramural Research; Mr. John Mahoney, Associate Director for Administration; Dr. Leamon Lee, Director, Division of Financial Management; Dr. Anthony Fauci in his capacity as the NIH Associate Director for AIDS Research; and Mr. Dennis Williams, representing the Office of the Secretary, HHS. I have a prepared statement, and with your permission, Mr. Chairman, I will submit it for the record and provide just a few highlights of it now. Senator HARKIN. It will be made a part of the record in its entirety. FISCAL YEAR 1991 BUDGET REQUEST Dr. RAUB. Thank you, sir. Our written justifications and the testimony you will be hearing later today emphasize many of the achievements of the last year. |