107th Congress

Fiscal Year 2002 Budget Request -- National Institutes of Health -- Hearing Before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education -- May 16, 2001

Members Present

Representatives Ralph Regula (R-OH), Chairman; David Obey (D-WI), Ranking Minority Member; Randy "Duke" Cunningham (R-CA); Kay Granger (R-TX); Ernest Istook (R-OK); Jesse Jackson, Jr. (D-IL); Patrick Kennedy (D-RI); Nita Lowey (D-NY); Dan Miller (R-FL); John Peterson (R-PA); Roger Wicker (R-MS).

Witnesses

Ruth L. Kirschstein, M.D., Acting Director, National Institutes of Health (NIH) accompanied by NIH Institutes and Centers Directors and NIH Office of the Director Staff

Summary

The purpose of the hearing was to present an overall view of the total Administration budget for NIH in FY 2002. Chairman Regula welcomed Dr. Kirschstein. He stated that recently he was telling a group of college students about NIH and noted that the American public is only vaguely aware of NIH's research and how it contributes to their quality of life.

Chairman Regula

Chairman Regula asked about the rationale behind the doubling of the NIH budget. Dr. Kirschstein stated that the logic was derived from many Congressmen, including the former chairman of this committee, John Porter, as well as many people in the advocacy community. She noted data showed that the NIH budget doubled over a span of 7 to 10 years and this rate was shortened to 5 years. Dr. Kirschstein asked Dr. Richard Klausner, Director, National Cancer Institute, to speak about a recent breakthrough in cancer treatment. Dr. Klausner discussed the approval of the drug Gleevec as an oral treatment for chronic myelogenous leukemia (CML).

Chairman Regula asked several questions regarding the grants awarding process. He also asked what NIH is doing to bring other disciplines into biomedical research. Dr. Kirschstein outlined several NIH training programs and initiatives, including the Biomedical Information Science and Technology Initiative program, a National Institute for General Medical Sciences training program in computational biology, and the newly-authorized institute, the National Institute of Biomedical Imaging and Bioengineering.

Chairman Regula asked if NIH was creating a bottleneck of discoveries and whether the Food and Drug Administration (FDA) could accommodate the review of new therapies and if other agencies could implement these discoveries. Dr. Klausner, using the drug Gleevec as an example, spoke about the process.

Chairman Regula asked about stem cell research, noting his understanding that other sources for stem cells were available. Dr. Kirschstein stated that recently scientific literature and the media have focused on the adult stem cell. She noted that only research following specific guidelines on the use of human pluripotent stem cells receive federal funds. Only organizations receiving federal funds are required to follow these guidelines. She stated that the field is moving rapidly and we have no clear picture of how stem cells are being utilized outside of organizations receiving federal funds.

Chairman Regula asked how NIH does research on rare diseases. Dr. Kirschstein stated that there is a specific definition for "rare disease". NIH spends approximately $2.5 billion on various rare diseases throughout NIH and has an Office on Rare Disease, which has information on its website available to the public. Chairman Regula asked if private patients were taken at NIH's clinical center. Dr. Kirschstein described NIH's protocol process and the clinical trials website hosted by the National Library of Medicine.

Chairman Regula asked about the percent of the NIH budget that is in-house research and had several follow-up questions about the grants process. He also asked how the recently released cholesterol guidelines were chosen. Dr. Claude Lenfant, Director, National Heart, Lung, and Blood Institute (NHLBI), stated that 27 top scientists deliberated for 22 months, and the new guidelines were the best judgment for the most common cholesterol cases.

Representative Wicker

Representative Wicker asked follow-up questions concerning the new leukemia drug treatment, specifically how many forms of leukemia are there and what percent of all cancers does leukemia represent. Dr. Klausner addressed these questions and stated that the take home message is that the way we think about disease needs to be redefined. Traditionally, disease has been defined by where it is located, now it is the molecular level that will help us treat disease.

Representative Wicker asked Dr. Kirschstein to provide an update on the Institutional Development Award (IDeA) program and the Biomedical Research Infrastructure Network (BRIN). He asked whether NIH was developing guidelines for these programs. Dr. Kirschstein noted that meetings were held prior to the development of guidelines and that there were specific guidelines but they also allowed for some flexibility. Dr. Vaitukaitus, Director, National Center for Research Resources (NCRR), spoke about a NCRR's program that was started before BRIN to assist universities compete for grants.

Representative Wicker stated for the record that many researchers in the 23 IDeA states are now ready to compete in a peer-reviewed process. He noted that there is a feeling of institutional bias in the awarding of grants to those who always get the awards and asked that everyone involved in the process be mindful of this.

Representative Istook

Representative Istook asked that NIH direct significant research dollars to reducing the cost of medical care and to providing new and better low-cost health treatments. He asked NIH to look at replicating or verifying a study done by Dr. Richard Anderson of United States Department of Agriculture's Nutrition Department. This study examined the effects of chromium on diabetes. Dr. Alan Spiegel, Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), spoke about the collaboration between NIDDK, the National Center for Complementary and Alternative Medicine (NCCAM) and the NIH Office of Dietary Supplement's efforts to study the effects of chromium, specifically identifying a FY 2002 chromium clinical trial. Representative Istook asked NIH to establish lower administrative costs when awarding grants to qualified institutions. He also asked NIH to continue programs that seek to award grants broadly, so that the information can be disseminated in broad geographic regions to the local practitioners. Dr. Alan Leshner, Director, National Institute on Drug Abuse (NIDA), spoke about NIDA's efforts to partner with drug treatment facilities around the country and noted that in FY 2002 NIDA would replicate their effort in drug abuse prevention arenas.

Representative Cunningham

Representative Cunningham asked that Dr. Klausner participate in a Washington, D.C., town hall meeting to address prostate cancer and to participate in a town hall meeting at the University of California, San Diego. Representative Cunningham noted that he has been trying to establish an Office of Men's Health, similar to the Office of Women's Health, at the Department level. He noted that this office would not compete with the Office on Women's Health, but would work to be a focal point for men's health concerns, and he asked for NIH's support.

Representative Kennedy

Representative Kennedy favorably commented on his recent visit to NIH. Representative Kennedy asked several questions about the status of mental health funding at NIH and asked for an update on the mental health working group at NIH. He also asked what NIH is doing to incorporate more behavioral research into all the disease research at NIH. Dr. Kirschstein discussed NIH's efforts on mental health research and stated that the Office of Behavior and Social Science Research will provide detailed information about how NIH incorporates behavioral research at NIH.

Representative Kennedy asked NHLBI, National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Environmental Health Sciences (NIEHS) to discuss genetics and the environment in asthma research. Dr. Lenfant discussed the collaboration between the three institutes. Dr. Anthony Fauci, Director, NIAID, provided an example of how NIAID is incorporating health disparities and behavioral research in an asthma study educating an inner city population about cockroach allergens. Dr. Kenneth Olden, Director, NIEHS, discussed a national allergy study looking at allergens in the home and a study looking at the health effects of air pollutants.

Representative Kennedy asked how NIH is addressing depression in the aging population, noting that he would like to assist NIH in developing a policy to ensure that senior years are golden years. Dr. Richard Hodes, Director, National Institute on Aging, noted that NIA in collaboration with National Institute on Mental Health(NIMH), is working to understand depression in aging and the processes of aging.

Representative Jackson

Representative Jackson asked for an update on the National Center on Minority Health and Health Disparities' (NCMHD) research endowment program. Dr. John Ruffin, Director, NCMHD, provided an update, noting funding of $6 million for both FY 2001 and FY 2002.

Representative Jackson asked Dr. Audrey Penn, Acting Director, National Institute of Neurological Disorders and Stroke (NINDS), to speak about NINDS' efforts on stroke in the African-American community. Dr. Penn discussed several initiatives, including a grant funded in the "stroke belt", an epidemiological study in Alabama and NINDS' work with a team of Morehouse University neuroscientists.

Representative Jackson asked Dr. Speigel to discuss how NIDDK collaborates with other institutes/centers on juvenile diabetes research. Dr. Speigel described the various collaborations that NIDDK has with NIAID and NCRR on juvenile diabetes or type 1 diabetes and also on collaborations with NHLBI, NINDS, NIMH, National Eye Institute, and National Human Genome Research Institute on type 2 diabetes.

Representative Obey

Representative Obey stated that the healthcare budget being proposed by the administration is preposterous. He stated his concern over cuts or minimal increases to other agencies, such as National Science Foundation (NSF), Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA). He noted that NIH relies on the science that often comes from other science agencies and that science is in jeopardy with these cuts.

Representative Obey asked about the out-year projections after the planned 5 year doubling of the NIH budget. He also asked how NIH would handle up-front funding of 3 year grants if the administration were to allow for it. Dr. Kirschstein stated that planning for out-year projections would begin this summer. Dr. Kirschstein stated that NIH would look into up-front grants funding, but noted, historically, the General Accounting Office had stated that it was not possible.

Representative Peterson

Representative Peterson noted that NIH is working to eliminate health disparities, but that "rural" health disparities are not specifically identified. Dr. Kirschstein noted that the rural population is defined as the underserved community and stated the rural population is not being ignored. He asked that the term, "rural," be used.

Representative Peterson asked what percent of budget goes to clinical research and if that figure has been constant. Dr. Kirschstein stated that about one-third of the budget goes to clinical research and stated the need for clinical researchers. She described a number of incentives that NIH use to attract clinical researchers, such as a loan repayment program.

Representative Peterson asked how NIH handles grants that are not showing promise. Dr. Kirschstein and Dr. Wendy Baldwin, Deputy Director of Extramural Research, NIH, discussed the NIH extramural grants process, noting that NIH works with universities/colleges to ensure the success of awarded grants.

In a follow-up to a question from Representative Kennedy on asthma studies, Representative Peterson asked if smokers are examined separately from non-smokers in NIH studies. Dr. Olden stated that the studies note the differences in smokers and non-smokers.

Representative Miller

Representative Miller expressed his appreciation for the work that NIH does. He stated his concerns that NIH is growing organizationally and asked which new entities were created by the Committee of Appropriations. He also asked when NIH was last authorized. Representative Miller stated that earmarking was a "slippery slope" and hoped the new chairman would resist the temptation to earmark NIH. Dr. Kirschstein stated that NIH was reauthorized in 1993 and noted that NCCAM and NCMHD were created through appropriations.

Representative Miller asked for an update on organ donation. Dr. Fauci discussed NIAID's work to ensure that individuals are able to tolerate transplantation. Dr. Speigel discussed NIDDK's work on end-stage liver disease, prevention of kidney disease to the progression of needed transplantations and living donor kidney and living donor liver transplantation studies. Dr. Kirschstein noted NIH's research on tissue engineering.

Prepared by Jennie Titsworth Kirby, OLPA