factors controlling hair growth, autoimmune aspects of the disease, pharmacologic interventions, and animal models. A new anatomic site that controls hair growth has been discovered, and the ability to grow hair in a test tube has been achieved. These findings open new avenues of research that will be pursued. Psoriasis is a common chronic skin disease characterized by scaling and redness produced by skin cells that divide rapidly. For many years, psoriasis was treated with preparations of tars and chemotherapeutic agents, such as methotrexate. Recently, clinical studies established the efficacy of cyclosporine A, an immuno-suppressive drug in the treatment of psoriasis. In turn, this has led investigators to explore the role of immune-mediated factors in causing the disease and to search for alternative drugs that cause fewer side effects than does cyclosporine A. The NIAMS is encouraging further exploration of molecular, immunologic, and pharmacologic aspects of psoriasis. Significant strides have been made in the Institute's Intramural Program. This past year two new laboratories were established to expand the scope of research: the Laboratory of Skin Biology and the Laboratory of Structural Biology Research. Fundamental studies of proteins responsible for maturation of the epidermis, the skin's outer layer, are the focus of research in the Laboratory of Skin Biology. In the Laboratory of Structural Biology Research, new sophisticated instrumentation is facilitating analysis of extremely small structures, including membrane-associated components of the AIDS virus. In the area of orthopaedic research, Intramural scientists have identified the various phases through which an injured bone must pass to heal properly. They have detected the presence of a specific natural protein, transforming growth factor-beta (TGF-beta), between and around the ends of fractured bone; and determined that TGF-beta not only initiates a repair response, but also controls the rate of fracture healing. Another ground-breaking accomplishment achieved by intramural scientists was the development of an animal model for eosinophilia-myalgia syndrome (EMS), a new epidemic inflammatory disease associated with ingestion of contaminated L-tryptophan. Symptoms range from those of the flu, to severe rashes and permanent nerve and muscle damage. The new animal model provides the first direct, experimental evidence linking EMS to contaminated batches of the dietary supplement L-tryptophan. Collaborations between NIAMS and the Department of Defense continue in studies of skin manifestations in human immunodeficiency virus (HIV)-infected individuals. Establishment of a new interagency agreement will significantly increase the rate of accrual of HIV-positive subjects into the studies to give US an earlier estimate of the prevalence of skin disorders and accelerate the pace of this research. Mr. Chairman, the budget request for NIAMS for fiscal year 1992 is $204,797,000. I will be pleased to answer any questions you may have. BIOGRAPHICAL SKETCH OF DR. LAWRENCE D. SHULMAN July 25, 1919, Boston, Massachusetts 1966-69, Education: Harvard University, A.B., 1941; Yale University Graduate Professional Organizations: American Association for the Advancement of Science, American College of Physicians, American Federation for Clinical Research, American Rheumatism Association (President, 1974-75), American Society for Bone and Mineral Research, The Arthritis Foundation, Brazilian Society of Rheumatology, Carla Curzio Neapolitan Society, Lupus Foundation of America, New York Academy of Science, Pan American League Against Rheumatism (President, 1982-86), Society for Clinical Trials, Sydenham Society, Society for Investigative Dermatology. Honors Awards: Senior Investigator Award, The Arthritis Foundation, 1957- NATIONAL PLAN Senator HARKIN. Thank you very much, Dr. Shulman. How soon are we going to have this national plan, did you say? I'm sorry. Dr. SHULMAN. It is going to be before the next hearings. Senator HARKIN. Good. Well, I had a question on osteoporosis, but you covered that. And lyme disease-you covered that quite well. And lupus. Just a moment. [Pause.] My apologies. I have to run over and cast another vote right now. My apologies. [A brief recess was taken.] QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Thank you very much. There will be some additional questions which will be submitted for your response in the record. [The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:] QUESTIONS SUBMITTED BY THE SUBCOMMITTEE OSTEOPOROSIS Question. Doctor, last year an additional $6.0 million was provided to the Institute for scientific research on osteoporosis, its causes, treatment and prevention. Please describe the progress you have made in this area. Answer. We are pleased to have played a lead role in the preparation of the Department's Report on HHS-wide Research, Education, and Health Promotion in Osteoporosis, prepared with the help of the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and delivered to the Senate Appropriations Committee. The Report provided information on the current status of osteoporosis research, specific research activities on osteoporosis by several agencies in the Department of Health and Human Services, and promising areas for future research. In response to current congressional interest and support for osteoporosis, two. Requests for Applications (RFA) have been issued to solicit applications in research on osteoporosis. One invites additional basic research on fundamental causes. The other invites more grant applications on clinical and epidemiological research on osteoporosis. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) expects a vigorous response from the research community to these solicitations. We anticipate funding up to 4 million dollars in outstanding new investigations in both the basic and clinical aspects of osteoporosis through this mechanism. The NIAMS is also participating with NIA in encouraging new applications for studies of the pathophysiology and mechanisms associated with particular intervention strategies against osteoporosis in the elderly. The NIAMS and NIA will each contribute up to $600,000 to fund studies solicited through an RFA. The NIAMS has participated for the last several years with the NHLBI and other institutes to fund the Postmenopausal Estrogen/Progestin Intervention (PEPI) Study. This is a multicenter, randomized, controlled clinical trial that will test the efficacy of various estrogen and progestin preparations in postmenopausal women. A variety of outcomes are being tested including bone mass and lipoprotein profiles. Question. I am aware that the drug "Etidronate" is a promising new treatment for preventing bone loss in humans. Can you summarize what is known about the potential of this treatment? At what point might it be available to the general public? Answer. The drug etidronate is an important new method for preventing bone loss in persons with osteoporosis. It does not promote formation of new bone, but it does retard further loss of bone. Etidronate has been available to the public for many years for other indications. It has been learned that giving the drug on a cyclic basis, to allow the bone to recover between treatments, prevents the impaired mineralization of bone that occurs when the drug is given on a continuing basis. New drugs, of the same class as etidronate, are being developed that may prove to be effective while not impairing mineralization. Question. What is the status of NIAMS's effort to educate the public and the health community about osteoporosis? Answer. The NIAMS has led a variety of activities aimed at better informing and educating these audiences. In terms of the public: o Our information office and clearinghouse handle hundreds of inquiries on osteoporosis each year. For this purpose, we have developed an information package that provides selected important articles on the topic and refers callers to other information sources, such as the National Osteoporosis Foundation. o We have distributed over 125,000 copies of our brochure "Osteoporosis: Cause, Treatment, Prevention." We are also developing a series of fact sheets on individual aspects of the disease that will enable us to provide thorough, up-to-date information as new findings are discovered. o We have a new brochure on osteoporosis, based on a Medicine for the Layman lecture, given by the Director, NIAMS. o We are reporting research results for the press and public, with a special mailing just before National Osteoporosis Prevention Week (starting May 8). In terms of the health community: o We continue to sponsor major scientific workshops on osteoporosis to review progress and up-to-date information, and suggest research directions. In 1990 we supported two such scientific workshops, one in February here in Washington and another in Copenhagen in October, an international consensus development conference that was recently published in the American Journal of Medicine. o At the request of the Department of Health and Human Services, we organized and coordinated with 16 other agencies a report to the Senate on osteoporosis research, education and health promotion activities in the Department, with recommendations for future activities. We will be printing this report in quantity this spring for both the research community, and health educators and program planners. We will utilize the report to encourage, lead and coordinate future work in both research and health education in this important disease. o The NIAMS sponsors an information clearinghouse that has prepared two in-depth bibliographies of educational materials, one for health professionals and the other for patients. The bibliographies list both printed and audiovisual materials. Through its database, the clearinghouse maintains an up-to-date listing of such materials for use by both health educators and health professionals. |