Senator ADAMS. Repeat that again, would you, Doctor? Dr. BUIST. This is particularly important, the clinical trials of optimal treatment, because of the increasing evidence that the way in which we treat asthma may in some way be responsible for the increase in hospitalizations and the increase in deaths. PREPARED STATEMENT Third, education. Asthma is underdiagnosed and undertreated. We need to educate the public, patients with asthma, their families, their teachers, employers, and very important physicians about this disease. A major educational program is presently under way under the auspices of the National Heart, Lung, and Blood Institute called the National Asthma Education Program. This program needs continued support and funding to insure its success. With this strategy, I believe we can turn around the numbers over the next 5 years. Thank you very much for your continued support of biomedical research. [The statement follows:] STATEMENT OF DR. SONIA BUIST Mr. Chairman and Members of the Subcommittee, the American Lung Association and the American Thoracic Society, ALA's medical section, thank you for this opportunity to comment on the health and biomedical research programs in the FY 92 budget. I am Dr. Sonia Buist, president of the American Thoracic Society. In my professional capacity I am Professor of Medicine and Head of Pulmonary and Critical Care Medicine at the Oregon Health Sciences University. At the outset, Mr. Chairman, I would like to thank you and the Subcommittee for your continued support of biomedical research programs. Diseases of the lung constitute a devastating and growing health problem in the United States. In 1989 it was estimated that 84.8 million Americans had chronic respiratory disease, a categorization including seven conditions ranging in severity from chronic sinusitis to asthma and emphysema. In the aggregate, lung diseases, including lung cancer, ranked third among the leading causes of death in 1988. There is growing concern regarding the increased morbidity and mortality from asthma, which is now the fourth leading cause of hospital discharges in children below the age of 15. The prevalence of asthma in males increased 44% between 1980 and 1989 while in females the rate increased 56%. Chronic Obstructive Pulmonary Disease (COPD) and allied conditions were among the most rapidly increasing of the top ten leading causes of death between 1979 and 1988. The combined direct and indirect costs of lung diseases (not including lung cancer) were a staggering $53.1 billion in 1989. The ALA/ATS has reviewed the lung related research, training and demonstration programs of the National Institutes of Health and other agencies conducting activities related to the prevention and control of lung disease. The recommendations we make today represent our best estimate of the adequate resources necessary to continue these programs at the level of priority funding indicated by the magnitude of the lung disease problem. This morning, the comments of the ALA/ATS will focus on two areas of concern: specific funding needs within the National Heart, Lung and Blood Institute, the primary source of federal funds for lung-related research, and Funding Needs within the National Heart, Lung and Blood Institute: The NHLBI research portfolio includes several research mechanisms of importance to lungrelated research. Of particular concern is the impact of funding guidelines for the grant mechanism, including the duration of a grant contained in the Appropriations Committee's report language for FY 91 and incorporated in the NIH Plan for Managing the Costs of Biomedical Research. Of equal concern are the continued inadequate funding of the Specialized Centers of Research Program (SCOR) and the proposal in the President's FY 92 budget for research training. The project grant remains the keystone of the NHLBI research portfolio. This includes the Regular Research Grant, New Investigator Award, FIRST Award, MERIT Award, Small Business Innovation Research Award, Program Project Grants and Cooperative Agreements. A major problem in the management of this mechanism is the provision of funding stability for investigators. Several years ago, the Institute adopted policies to increase the average duration of grants as one initiative to remedy this problem. In report language for FY 91, the Appropriations Committees instructed NIH to limit the average length of its grants to 4 years. Under this action, the large portfolio of clinical studies and program project grants at the Institute is likely to suffer if implemented according to NIH plans. The NIH has excluded the Small Business Innovation Research Award from calculations for the average duration of a grant. Implementation of the Committees' instructions under this plan would require the Institute to remove, administratively, one year of funding for over 50% of its project grants approved for 4 or 5 years in order to meet the 4-year average limitation. This change will only serve to put instability back into the funding system. To remedy the situation, the ALA/ATS recommends the following: the Appropriations Committees should further instruct the NIH regarding steps to achieve a 4 year average duration for a grant to provide for inclusion of the SBRIS in the calculations. This will enable the Institute to achieve a 3.9 year average allowing it to fund its grants at the approved funding levels without reductions in the Begun in 1971, NHLBI funds 65 SCORS focused on 12 areas of research. Its Division of Lung Diseases supports 25 centers covering 7 areas of research. The SCOR program was developed to advance basic knowledge and to generate the most effective methods of diagnosis, management and prevention of disease. Funded on a competitive basis for 5 years, SCORs are designed to encourage the concentration of research resources, facilities, and personnel on selected research issues. The SCOR program continues to be inadequately funded, receiving a 3% decrease in support since 1988 although the Institute, by legislative mandate, has initiated 2 new programs funding a total of 5 new centers in the same period. Moreover, program imbalance magnifies the funding problems. For example, funding increases for project grants represent a 15% increase in the percentage share of the Institute's extramural budget while the Centers have received a 31% decrease in percentage share. In FY 91, the majority of the lung SCORS are to be competitively renewed. As a consequence of continued funding shortfalls and a change in the distribution of funds between research mechanisms, the SCOR program has been severely compromised and adequate funding for the renewal process is questionable. The ALA/ATS recommends several steps to restore and rebuild the SCOR program: for FY 92, an additional $11 million should be provided for the Centers the NIH should be instructed to explore steps to stabilize funding for this Research training is critical to continued advances in the prevention and control of lung disease. The President's budget proposal for FY 92 provides funding for the same number of trainees as FY 91, with a 4% increase in the stipend. This is achieved by adjusting the ratio between predoctoral and postdoctoral trainees. Postdoctoral training is an important component of the overall research program of the NHLBI. Its training program currently includes 65% postdoctoral and 35% predoctoral trainees, the predoctoral positions being less costly. Under the President's proposal, postdoctoral trainees would decrease to 34% for competing awards. The ALA/ATS is concerned that sufficient qualified predoctoral applicants will be found to meet this adjusted ratio and further, whether such a costs savings strategy will jeopardize future research manpower needs. The ALA/ATS recommends the following: an increase in the number of training positions from 1,624 to 1,800 with for FY 92, an additional $7.7 million should be provided to meet the moderate Research and Education Initiatives on Asthma: Asthma is one of the most common chronic diseases in the United States. Today there are an estimated 10 million asthmatics, 3.2 million under the age of 18. The most frequent cause of hospital admissions for children, asthma also leads the list of childhood diseases causing significant lost school days. Over 4,000 individuals die each year in the U.S. from asthma and there is growing evidence that U.S. mortality rates are increasing. In 1987, mortality rates for ages 5 to 34 years were greater than in 1969. Overall direct and indirect costs from asthma are estimated to exceed $4 billion annually. Research on the mechanisms involved in the pathogenesis, diagnosis, treatment and prevention of asthma is critical to reducing the morbidity and mortality from this growing health problem. The National Institutes of Health supports a broad range of research activity, both basic and clinical, and education programs specifically within the NHLBI and the National Institute for Allergy and Infectious Diseases. Clinical research activities include the NHLBI's SCOR program in Chronic Airways Diseases, which is directed at the pathogenesis of airway reactivity in children and adults with asthma; NHLBI's Childhood Asthma Management Program, which is evaluating three long-term therapies for asthma in children; NIAID's network of Asthma and Allergic Disease Research Centers specifically directed at improving the diagnosis, treatment and prevention of asthma; and NIAID's National Cooperative Inner-City Asthma Study designed to identify those factors leading to increased morbidity and mortality in the inner-city minority population. These initiatives have established an invaluable information base on the complex biological mechanisms underlying asthma. Continued support of such efforts will provide information critical to the effective treatment and management of asthma and eventually, the prevention of morbidity and mortality. The NHLBI initiated the National Asthma Education Program in 1989 to raise the awareness of asthma as a serious chronic disease and to promote more effective management of asthma through patient and professional education. The coordinating committee represents various national medical, public health, voluntary and government organizations including the ALA and ATS. On February 5 of this year, the Institute issued its first report the program, Guidelines for the Diagnosis and Treatment of Asthma. These guidelines are the result of an 18-month effort by an expert panel and were developed to provide physicians and other health care providers with state-of-the-art consensus guidelines for the diagnosis and treatment of asthma. The guidelines represent a critical step in efforts of the Institute and organizations such as the ALA to address the increasing problem of asthma and its resulting health care costs. Improper treatment and management of asthma is thought to be one reason for the alarming increase in its morbidity and mortality. Additional research resources are necessary if we are to properly attack the many health care problems posed by asthma. For example, the Childhood Asthma Management Program should be expanded to study optimal therapies for the adult including therapies for adult onset of asthma. Additional research efforts are also necessary to better understand asthma in females. In approximately one-third of women, for example, asthma becomes worse during pregnancy. Since poorly controlled asthma has been shown to have an adverse effect on the fetus, use of drugs for optimal management has been considered justified. However, their safety has not been unequivocally proven. Areas of needed study include the most effective medications, the effect of medication during lactation, treatment of acute exacerbations, and medications and fetal development. In summary, Mr. Chairman, Oscar Wilde once said, "One never knows how much is enough until one knows how much is too much. According to that dictum, those of us doing lung research have no basis for deciding how much support is enough--it has never been excessive. Any dollar figure for what is essential to take reasonable advantage of the available research opportunities and to assure the viability of the lung research community is a best guess. Your continued support for adequate biomedical research funding is greatly appreciated. AIR QUALITY Senator ADAMS. Thank you very much for your testimony. I am concerned, Doctor, with the increasing environmental impacts that we are having, particularly in our cities and in the central parts of our cities with both noxious fumes and so on and the reports that we hear nightly on television that air quality is at a particular level. Can you give me in a capsulized form why you believe we have not been able to get to a more fundamental basic either connection or way of treating asthma? I did not say cure because I do not know enough about it to know whether cure is possible, but that is why I stopped you in the middle of your testimony. It appears that we may simply be treating the symptoms in such a way that we are not assisting the person to ever improve in their basic health condition. I think that is what you indicated. Dr. BUIST. Yes; that is exactly right. With asthma we are primarily treating the symptoms, and until recently at least we have not been treating the underlying disease, which is basically inflammation of the airways which closes off the airways. We think we know a little more now about the more appropriate treatment, which is the treatment of the inflammation rather than just the constriction of the airways, but we know very little about how to prevent it, and we know very little about the causes of asthma. Until we find out more about the fundamental cause, which is the complex interplay of genes in the environment, we really cannot move toward prevention or treatment based on rational science. Senator ADAMS. It really does bother me that we are technically able to do such things as we were able to demonstrate in this recent conflict and that we cannot determine the causes of inflammation of certain parts of the human body when this has been such a major affliction for such a long time. I wish you luck in your research, and I hope we will be able to fund it. Your testimony was excellent. We appreciate it. Dr. BUIST. Thank you. Senator ADAMS. Thank you. STATEMENT OF ALAN SCHREIBER, M.D., ASSISTANT DEAN FOR RESEARCH AND PROFESSOR OF MEDICINE, UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE, ON BEHALF OF AMERICAN SOCIETY OF HEMATOLOGY Senator ADAMS. Next, Dr. Alan Schreiber, University of Pennsylvania, School of Medicine, American Society of Hematology. Doctor, I welcome you on behalf of myself and Senator Specter. I am sorry that he had to leave to go back to another hearing, because he would want to personally welcome you. Dr. SCHREIBER. Thank you. I understand. Senator Adams, I represent the American Society of Hematology and its more than 4,000 scientists, physicians, and biomedical investigators. First, I want to thank you, Senator Adams, and Senator Specter, and the staff and your colleagues on the committee for all their help over the years in support of the National Institutes of Health and particularly over the past year. There has been, as you know, a virtual explosion in molecular biology research, and this offers us unprecedented opportunities to lead the world in biomedical research and in biomedical research technology. In biomedical research technology we have an opportunity to make an impact economically over the coming years in our country's national growth. The cornerstone of biomedical research for this kind of growth is funding for the National Institutes of Health. The explosion in molecular biology technology has made impacts already, as you know, in terms of the delivery of the new types of therapy we are affording to patients. Just over the past year, the growth factor genes that have been cloned have produced the products that are now being given to cancer patients and patients who have an inappropriate deficiency in the production of blood cells. This is making inroads in saving lives and in keeping people out of hospitals because these factors can be administered at home. So patient hospital days are decreasing considerably from the administration of such factors. You know the work on bone marrow transplantation which has had a major impact through your colleague, Don Thomas, at the University of Washington. The Nobel Prize in Medicine was awarded to Dr. Thomas this year for his work in bone marrow transplantation and its revolutionary contributions. Dr. Thomas will be coming to Washington with us on June 12, to meet with you and colleagues to talk about these issues. The explosion in molecular biology technology has also led to the new and exciting area of gene therapy. It was only a few months ago when a gene that had been recently cloned was administered to the blood cells of a patient whose blood cells were taken from this patient. She had an immune defect and she was deficient in this gene. Then after the gene was inserted into her blood cells, these blood cells were inserted back into her blood, which has partially reconstituted the defect, the immune defect that she had. This opens up this new vista of gene therapy. It is a very exciting opportunity for us. Last year we asked you to work with the NIH to develop the manpower requirements, the resource requirements, and the train |