107th Congress

Report: FY 2003 Appropriations Theme Hearing: "Collaborations in Biomedical Research"—Hearing Before the House Appropriations Subcommittee on Labor, HHS, and Education—April 9, 2002

Members Present

Representatives Ralph Regula (R-OH), Chairman; David Obey (D-WI); Roger Wicker (R-MS); Anne Northup (R-KY); and Donald Sherwood (R-PA)

Witnesses

Ruth Kirschstein, Acting Director of the National Institutes of Health (NIH); Stephen Katz, Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Stephen Straus, Director of the National Center for Complementary and Alternative Medicine (NCCAM); Duane Alexander, Director of the National Institute of Child Health and Human Development (NICHD); Donna Dean, Acting Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB); John Ruffin, Director of the National Center on Minority Health and Health Disparities (NCMHD); Gerald Keusch, Director of the Fogarty International Center (FIC). Also in attendance was Kerry Weems, Acting Deputy Assistant Secretary, Office of the Assistant Secretary for Budget, Technology, and Finance, Department of Health and Human Services (DHHS).

Purpose of Hearing: This hearing was the fourth NIH fiscal year (FY) 2003 appropriations hearing and the third of five theme hearings. The hearing was held to highlight specific activities of the Institutes and Centers (ICs) in collaborative efforts at NIH.

Summary

The Subcommittee Members generally took this opportunity to ask questions about the missions of the institutes on the panel, discuss issues of personal interest, and offer comments relative to specific institutes. There was discussion of:

• Complementary and alternative medicine—what exactly does it mean? NIH Web sites and clearinghouses—what are they?
• The problem of obesity and children and risk for developing diabetes.
• What is being done to reach rural America on health issues?
• Is there adequate research on teaching modalities to determine what is most effective in teaching children to read?
• Can NIH give definitive statements on certain treatments and be the single authority for answers?
• Has there been undue influence on NIBIB to locate its intramural program in a particular state or location?

Representative Obey spoke at length about his concerns about the creation of NIBIB and whether it would drain resources and programs from the other ICs. Representative Obey stated that this Subcommittee has, on almost all occasions, resisted efforts by Members of Congress to "put their mitts" on health research or determine how or where research should take place. He said that to do so would discredit the research.

Opening Statements

Dr. Kirschstein provided brief opening remarks, noting that collaborations are important to modern day biomedical research. These collaborations exist between the ICs; between NIH and other DHHS agencies; and between NIH and other Federal agencies, industry, private foundations, philanthropic organizations, and patient advocates.

Chairman Regula asked for an explanation of alternative medicine. Dr. Straus explained that alternative medicine is medicine that is widely used but has not been proven.

Dr. Katz discussed NIAMS' osteoarthritis initiative. He explained that osteoarthritis is the most common form of arthritis and that there are 20 million people who currently have osteoarthritis. He said the numbers will continue to increase as the numbers of elderly people in our population continue to rise. NIAMS created the osteoarthritis initiative which is a public/private partnership to study osteoarthritis over a 7-year period, in collaboration with the National Institute on Aging, the National Institute of Dental and Craniofacial Research, the Office of Research on Women's Health, NCCAM and NCMHD, as well as several pharmaceutical companies.

Dr. Straus stated in his opening remarks that NCCAM uses research to determine which complementary and alternative medicines are safe and effective. Dr. Straus explained that NCCAM collaborates with the National Cancer Institute (NCI) because many patients with cancer often turn to complementary medical practices. NCCAM has two of their largest studies with NCI. The first study is looking at shark cartilage as a treatment for lung cancer, and the second study is looking at the effectiveness of vitamin E and selenium to prevent prostate cancer. Dr. Straus also discussed NCCAM's collaboration with the National Library of Medicine's CAM on Pubmed. This database has over a quarter of a million articles on complementary and alternative medicine.

Dr. Alexander discussed NICHD's partnership with the National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute on maternal and fetal medicine units which conduct trials to improve pregnancy outcomes. NICHD's largest collaborative activity is the longitudinal environmental health study, on which it has partnered with 22 institutes, 11 agencies, and 9 departments including the Centers for Disease Control and Prevention, the Environmental Protection Agency and the National Institute of Environmental Health Sciences. The "Back to Sleep" campaign is one example of NICHD's successful collaborations. Since the "Back to Sleep" campaign began, SIDS deaths in the United States have been cut in half. This campaign has also specifically targeted minority populations.

Dr. Dean explained that the existence of NIBIB is rooted in collaboration. She noted that as part of the establishment of the institute, a number of projects have been transferred from other institutes to NIBIB. A study on microfabricated microneedles for drug delivery was transferred from the National Institute of General Medical Sciences. Dr. Dean also announced NIBIB's first grant award.

Dr. Ruffin stated that NCMHD is the focal point for the planning of minority health initiatives at NIH. NCHMD is building research infrastructure and capacity at dental schools that train minority dentists, and it conducts collaborative research aimed at reducing the disparity in oral health in minority and rural populations.

Dr. Keusch discussed the importance of collaborations in international research. He explained that there are three large global programs on AIDS, tobacco, and environmental health. These programs include 65 countries, including countries in Eastern Europe and the former Soviet Union.

Questions

Representative Regula

• Representative Regula asked Dr. Kirschstein if these collaborations could be characterized as clearinghouses; and, for example, if a person has a question on osteoarthritis, would that person go to Dr. Katz? He asked if a clearinghouse was one stop shopping for people to get information. Dr. Kirschstein explained that NIH uses the term "clearinghouse" in a very specific way. A clearinghouse for NIH is a place where information is stored and is made available to the public. As an example, she mentioned the website for all NIH information relative to clinical trials is http://clinicaltrials.gov. He asked if this information includes information outside of the United States. Dr. Kirschstein replied that it does include clinical trials outside of the United States.


• Representative Regula asked Dr. Straus if the public could get information on CAM from NCCAM's website, and how does NCCAM handle calls from the public. He also asked if acupuncture is effective.


• Representative Regula stated that he had heard about a knee injection that is supposed to produce cartilage and has been used to help with osteoarthritis. He wanted more information on this. He also asked if the institute includes information from around the world.


• Representative Regula asked where the public might find good answers about the negative effects of drugs. Dr. Katz stated that all drugs have risks and benefits and people often have to rely on their physicians' professional judgment. People need to balance the benefits with the risks.


• Representative Regula asked if there is a correlation between someone believing they will get better and that person actually getting better. Dr. Straus explained that the power of the mind does play a role in whether or not a person will get better. Dr. Straus stated that there is currently an announcement to study the placebo effect.


• Representative Regula asked if there have been any studies done on the correlation between health and economics and the role of the World Health Organization. Dr. Keusch stated that there have been studies, and these studies show that there is a correlation between longevity and the wealth of a nation. Dr. Keusch said FIC is sponsoring several studies in developing countries to research this concept.


• Representative Regula asked Dr. Keusch if he thought the mantra "leave no child behind" should include a health component as well as an educational component.


• Representative Regula noted that the budget has $40 million for NIH to do collaborative research with the U.S. Department of Defense. He asked what did that mean and whether the money would be well spent.

Representative Obey

• Representative Obey asked Dr. Kirschstein what criteria will be used to determine which studies will go to NIBIB and which studies will stay in their current institutes. Dr. Kirschstein explained that NIH shares some of his concerns, and she understands that NIH needs to work hard to ensure this new institute succeeds. She explained that NIH will use the criteria that were set based on strategies that have been used to establish other institutes. Dr. Dean explained that she prefers to see NIBIB as an additive to NIH, and it does not subtract or detract from the other institutes.


• Representative Obey stated that there have been some press reports that NIBIB will not be located on the main NIH campus. He asked if there are any plans to have the institute located elsewhere. Dr. Kirschstein said that there are no such plans. He then asked Dr. Kirschstein to comment on the need to keep the intramural programs located together. Dr. Kirschstein stated that the programs all work together and geographic separation would make it difficult to work together, especially with a new institute.

Representative Sherwood

• Representative Sherwood asked what Federal, state, and private agencies NICHD is working with to reduce obesity. Dr. Alexander stated that there has been an enormous increase in obesity among young people, the Secretary of HHS is very interested in this topic, and the Secretary has pulled together a task force on this topic. Dr. Alexander recommended that two places to focus this effort are physical education in schools and school lunch programs.


• Representative Sherwood stated that he has been told that it is difficult for health care professionals to find technicians who can use new imaging technology. He asked Dr. Dean what NIBIB is doing about this.


• Representative Sherwood asked if Dr. Ruffin was aware of any studies of health disparities in rural areas. Dr. Ruffin explained that this issue is why the new center was created, to include underserved populations as well as minorities.


• Representative Sherwood asked if FIC is involved in tracking health threats and how they determine what the threats are. Dr. Keusch stated that FIC is not involved in surveillance. He explained that their job is to better understand the diseases in order to treat them.

Representative Northup

• Representative Northup discussed her concern about mental health and asked if there was any research being conducted on time-released drugs that are used to treat mental health issues. Ms. Northup asked if there were any slower release or time release drugs being developed for mental illness. Dr. Kirschstein stated that they would have to check with the National Institute of Mental Health.


• Representative Northup discussed her interest in CAM, but she stated her concern about the untoward effects these treatments may have. Dr. Straus stated that the problem is that some drugs have not yet been studied. NCCAM is not only studying effectiveness, but it is also studying what impact drugs may have on other parts of the body.


• Representative Northup asked how to ensure that every child succeeds in school, and whether there is adequate short and long-term testing and research done on the programs now being funded. She also asked whether there can be standards to determine if a program is truly research based. Dr. Alexander explained that NICHD has brought scientific rigor to the research on the effectiveness of the reading instruction. He commented that the research money they were asking for this year focuses on pre-school research and is a collaborative effort with the Administration for Children and Families, DHHS.

Prepared by Keri-Lyn Wall, PMI, Office of Budget, April 11, 2002