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ENTERING A NEW ERA

Question: In your FY 82 justifications, you make two rather
You say that "mastery of the immune

startling statements.

"

system...is at hand.' You also say that "we are entering a new era. This all sounds like the coming of a "Golden Age of Medicine." Please explain.

Answer: Although earlier research has curbed the major epidemic diseases, many common infections caused by viruses and parasites as well as many chronic diseases have resisted attack. And hazards once controlled have reemerged with the changing fortunes of evolution.

These formidable problems, but new applications of research developments, which have emerged in the past 20 years on the physiology of the immune system and the molecular biology of microbes are opening new strategies for treatment and prevention.

Clinical immunologists are applying our increasing knowledge of the immune system to regulate, in novel ways, the destructive processes in patients with diseases such as lupus erythematosus and asthma.

The programming of bacteria to produce medically useful substances using recombinant DNA technology is creating unanticipated opportunities to improve old vaccines and develop new ones as well as to manufacture other substances such as hormones and the antiviral agent interferon.

Using hybridoma cell fusion techniques it is possible to produce in the laboratory, at will and in a predictable fashion, antibodies with exquisite purity and of the highest quality. Never before has this been possible. These products will facilitate the development of vaccines, enhance immunotherapy of infections and malignant diseases, improve diagnostic tests, and serve as new probes to examine the innermost secrets of living processes.

The use of hybridoma cell fusion in conjunction with recombinant DNA technology will have an extremely powerful, potentiating effect on the pace of biomedical research. Together, the two technologies will multiply the pace of research rather than double the effort. Already they are being used in branches of medicine as diverse as rheumatology, cardiology, oncology, endocrinology, neurology as well as specialities concerned with infectious and genetic diseases.

For these reasons I have said we are entering a new era, a new "golden age of medicine" that will equal or surpass the last century of achievements.

Question: In the face of this statement of hope, you propose to cut back on your new research by reducing new and competing research grants from 268 to 250. Why?

Answer: The budget amount for this program is currently under discussion within the Reagan Administration. After the revised budget is forwarded to the Congress, we will provide an appropriate answer to this question.

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IMMUNOLOGIC DISEASES

Question: In 1978, the Institute established four centers to accelerate clinical application of new knowledge on the immune system. What type of research areas are under investigation at the Centers for Interdisciplinary Research on Immunologic Diseases?

Answer: A variety of efforts are now under way. Studies in asthma range from approaches to teach asthmatic children how to manage their illness to studies of why children who experience respiratory syncytial virus infections subsequently develop asthma. Representative studies of hypersensitive reactions include approaches to improve methods for evaluating patients having adverse reactions to therapeutic drugs and, for example, methods for oral desensitization of patients who are allergic to penicillin. Other studies are designed to develop the capability for early diagnosis of serious fungal infections in immunologically compromised patients and to develop a safe bacterial vaccine against Haemophilus influenzae, a common and potentially serious infection of infants.

Question: Have you been recruiting and training clinical investigators for these centers? Where do you stand on this?

Answer: We strongly believe that the centers provide an excellent training environment. However, the center awards are limited to support of research; and support for training on a formal basis is prohibited by the conditions of the award. Nevertheless, the senior staff investigators at the four currently funded centers informally provide guidance and training for their younger clinical and laboratory associates during the course of the research studies. Support for these individuals generally is provided by some type of training grant or fellowship award from this Institute or others under the provisions of the National Research Service Awards Act. Our position has been, and will remain, one of encouraging the senior investigators at these centers to continue their informal efforts and to develop formal training programs.

ALLERGY AND ASTHMA

Question: What progress has been made during the past year in research on asthma and allergic diseases?

Answer: The chemical structures of several substances (called mediators) that cause inflammation and allergic reactions in man have been clarified. This new information is expected to permit the rapid development of drugs that will offset these reactions. Similarly, progress in identifying substances in serum that will either increase or diminish allergic reactions should permit development of new ways to treat allergies on a general, broad scale, as opposed to treatment for a specific allergen thought to be causing a reaction.

Question: Have the Asthma and Allergic Disease Centers provided any new insights into the cause, treatment, or prevention of these conditions?

Answer: Studies on the role of bronchoprovocation tests to diagnose asthma have been extended to include family members of asthmatic persons. Results show that these tests can be used to predict which family members will contract asthma within the next 3 to 5 years. It is hoped that detection and prevention programs can

then be developed. The cause of asthma in some children appears to be related to prior infection with respiratory syncytial virus. When this finding has been fully confirmed, a vaccine could be developed that may prevent asthma in such children.

In addition, significant progress has been made in both the diagnosis and treatment of allergic reactions to penicillin. Both skin tests and certain laboratory tests can identify penicillin allergy with a high degree of accuracy, and treatment regimens have been developed that permit rapid oral desensitization so that this life-saving drug can be used if needed.

Question: Can an individual "outgrow" allergies?

Answer: Usually, after the ability to react to a particular allergen has developed, it remains for life. This is especially the case in adults and where airborne inhalant allergens are concerned. However, tolerance may occur to some extent with time. In as many as 10 percent of cases, acute allergic reactions may disappear, with no allergic reactions of consequence resulting on future exposure.

Question: Is there a genetic predisposition to certain

allergies?

Answer: Some investigators believe that there appears to be a genetic predisposition to hay fever as well as a familial--and therefore probably genetic-tendency to develop asthma. Certain types of skin allergies are believed also to be influenced by genetic factors.

INTERNATIONAL BIOMEDICAL RESEARCH

Question: The Institute's International Biomedical Research Program conducts research and scientific training on infectious diseases important to the health of the world's developing countries. The ultimate goal is improved technology for preventing, diagnosing and treating these diseases. In what areas of research are you

cooperating with other countries?

Answer: NIAID conducts international research "to advance the status of the health sciences in the United States and thereby the health of the American people through cooperative endeavors with other countries in health research, and research training.' This collaboration is carried out by intramural NIAID staff, awards to U.S. universities to conduct research overseas, and exchange research fellowships or direct grants to foreign scientists. Bilateral science and technology agreements between the U.S. and host governments frequently provide a formal basis for collaborative activities in tropical medicine, microbiology and immunology.

During FY 1980 NIAID launched a new program of awards for U.S. scientists for International Collaboration in Infectious Disease Research (ICIDR) in developing countries. These awards were made to universities to work in parasitic diseases or leprosy with counterparts in seven developing countries (Brazil, Colombia, India, Mexico, Nigeria, Sudan, and Thailand).

At the present time NIAID intramural scientists are involved in collaborative work in West Africa on the mechanisms of immunity to malaria, in India on the pathogenesis of tropical pulmonary

eosinophilia, and in Brazil and Argentina on the reasons why certain patients develop chronic heart and intestinal disease following infection with American trypanosomiasis (Chagas' Disease) while others do not. Current efforts are directed towards epidemiological studies of non-A, non-B hepatitis in India and field trials of hepatitis B vaccine in the Peoples Republic of China to prevent transmission of hepatitis B from the mother to the newborn. NIAID scientists have carried out a collabaorative project involving more than 20 countries to isolate viral agents which produce diarrhea.

[CLERK'S NOTE.-The following is the administration's response to those questions in the record that were under review by the Secretary at the time the Department submitted earlier responses.]

MAINTAINING NEW RESEARCH GRANTS

Question: The fiscal 1982 budget continues to emphasize the stabilization of new, investigator-initiated research grants for NIH at 5,000. How much funding will you need in fiscal 1982 to maintain your share of the NIH goal of 5,000 new and competing research grants?

Answer: The revised budget request, proposed by President Reagan, provides for the funding of approximately 4,900 new and competing research project grants for $571,621,000. The NIAID share of that amount is $44,804,000 and 414 grants.

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How is inflation impacting or how will it impact on this goal? What inflator are you using?

Answer: An inflation factor of 9.5 percent was taken into account in developing the cost of funding the 4,900 new and competing research project grants.

Question: Why is it so important to stabilize new research grants regardless of other budget priorities within NIH?

Answer: "Stabilization" is important both to the government and to the scientists. For the government it means that a reasonable number of research projects deemed by peers to be of high scientific merit and relevance can be funded. This is the likely source of the new knowledge and technology we need to solve health problems that are now approachable with, at best, what has been termed halfway technology. For the scientist it means that he knows there is a reasonable chance of getting research ideas funded and encourages him to stay in research rather than earn a living elsewhere.

Question: What happens if, in a particular year, the quality of new research proposals declines? To what extent would you then want to fund fewer new grants and put greater emphasis on research contracts or intramural research?

Answer: This has to be regarded as a hypothetical question since funds have never permitted payment of more than about 40 percent of approved applications; in most years paying a third or fewer. If a drop in the number of applications gaining approval made it possible to fund more than half, the Institute would seek reprogramming authority to divert funds to research contracts. While an individual application judged to be of intermediate merit (priority score 230-270) might be funded because of program relevance, the funding of research contracts, career development

awards, and training would take precedence. Progress in new vaccines and antiviral drugs depends on research contracts.

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Question: To what "payline" will you fund new and competing grants in fiscal 1981 and if you can estimate it in FY 1982? What percentage of grants will you fund in both years?

Answer: In FY 1981 and 1982 under the revised budget request we would fund competing research projects to a payline of about 180 and 170, respectively. The revised budget would permit funding of approximately 31 percent of eligible competing research projects in FY 1981 and 25 percent in FY 1982.

WHERE TO CUT

Question: If faced with a major budget cut back, what are your priorities? Where could cuts be made without impairing essential research?

Answer: In making reductions from the budget submitted to you in January we have attempted to develop a budget which maintains a viable research program for FY 1982 and strikes a balance among research grants, intramural activities and training. While these reductions will not impair essential research, further cuts may alter this balance as well as our research capability.

Question: How much can be saved through more efficient management, less official travel and fewer consultant contracts?

Answer: In 1981 cuts were made in travel, consultant services, procurement contracts and personnel compensation because of the hiring freeze. Further reductions in consultant services were made in 1982. Additional cuts in these areas in FY 1982 could not be absorbed without affecting essential research activities.

ENTERING A NEW ERA

Question: In the face of this statement of hope, you propose to cut back on your new research by reducing new and competing research grants from 268 to 250. Why?

Answer: The figures cited represent only the numbers of competing renewal grants requested in the 1982 revised budget request. The total number of competing grants (new, competing renewal and supplemental) requested in the 1982 revised budget decreases from 430 in FY 1981 to 414 in FY 1982.

It should be noted that the Institute is requesting an increase in funding for competing grants but tempered the amount in order to maintain program balance between its several funding mechanisms. Rapidly increasing costs in grantee institutions, particularly indirect costs such as fuel or plastic laboratory ware derived from petrochemicals, suggests that the dollar increase we have requested will pay fewer grants. Despite this decrease, we expect the number of grants related to the new thrusts in research that I have mentioned to increase since applications in these areas have the highest priority.

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