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the Hablo identical bone marrow transplant, improved new therapies such as PEG ADA, which is very similar to the enzyme replacement used in Gaucher's disease-very expensive, but effective.
And we are all very excited, and the big hope is what is going on right now with human gene therapy at the NIH being performed on a child with severe combined immune deficiency. That is the difference a decade has made.
The bad news really is that the Immune Deficiency Foundation, which is a very small and underfunded organization, has for the past 7 years probably supported one-half as many training fellowships in primary immune deficiency, as has the entire NIH. When we offer a $10,000 research award, we are overwhelmed with good applications that we cannot fund. They are coming to us because the NIH funding has not been adequate, or is not adequate at this time, and many young scientists are not continuing in the field.
If you want immunologists in the future, and you want to see good basic research, particularly when problems like AIDS come along, those of us concerned with primary immune deficiency, those concerned with secondary immune deficiencies, and those concerned with autoimmune deficiencies, or disorders, all think that something should be done now to ensure that research and training levels in immunology will be sufficient. Thank you.
Senator BURDICK. Thank you very much.
Mr. HUMPHREYS. Thank you, Mr. Chairman.
STATEMENT OF CHARLES M. HELMS, ASSOCIATE PROFESSOR OF MEDICINE, UNIVERSITY OF IOWA COLLEGE OF MEDICINE, ON BEHALF OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA Senator BURDICK. Dr. Charles Helms of the Infectious Diseases Society of America.
Dr. HELMS. Good morning, Senator Burdick. I am Charles Helms, a faculty physician at the University of Iowa College of Medicine, representing the Infectious Diseases Society of America. The society is a body of about 2,500 specialists who care for patients with infections and hope, through research, to improve patient care in the future.
We are pleased to have the opportunity to present our views today on the National Institutes of Allergy and Infectious Disease, and the Centers for Disease Control funding.
Mindful of time constraints, Senator, let me come right to the point. We have reviewed the 1992 budget and earlier budgets, and congratulate the Congress for its wisdom in providing support for the NIAID and CDC in recent years. We feel the 1992 NIAID budget, with its 7.7 percent overall increase in spending, is a balanced, positive step in the right direction.
Similarly, we welcome the major increases which have occurred in the overall budget of the CDC. The society applauds this longneeded re-emphasis on disease prevention emerging from Senator Harkin and other Members of Congress, as well as the administration.
Having given credit where credit is due, in our written testimony we respectfully call your attention to concerns the society has in relation to NIAID and CDC budgets. We touch on a few of them here. Only 22 percent of approved grants for competing research projects would be funded under the proposed NIAID budget.
To sustain research progress, the society would recommend appropriations sufficient to permit an award rate of 40 percent. Downward negotiation in grants awarded by NIAID is hampering research. The society recommends appropriations sufficient to assure full funding of awarded grants.
In the era of AIDS, the society believes an increase in appropriations for individual and institutional research training awards is appropriate to ensure sufficient numbers of future infectious disease researchers and practitioners. Vaccine research and development hold real promise of saving lives, preventing illnesses, and averting health care costs. We urge sufficient funds be appropriated for research and development initiatives recommended under the national vaccine plan.
The society is concerned that, despite a record budget, the CDC's core efforts have lost ground, from a budget of $180 million 10 years ago to $163 million today. We urge increased appropriations for much-needed core activities.
Substantial improvements in the infrastructure of NIH and CDC are needed to maintain pre-eminence in biomedical research and public health research. Clinical facilities and laboratories must be updated. Senior staff physicians and scientists must be recruited and retained at both institutions. The allocation of significant numbers of senior biomedical research service slots will be needed at both the NIH and CDC.
Mr. Chairman, the society recognizes that you and the subcommittee must make difficult choices in the weeks ahead. We appreciate your support for the NIAID and CDC in the past, and thank you for your willingness to hear our thoughts on these is
Senator BURDICK. Thank you for your testimony. You raise some excellent points, and I will be glad to relay them to Senator Harkin. Thank you.
[The statement follows:]
STATEMENT OF CHARLES M. HELMS, M.D, PH.D., ASSOCIATE PROFESSOR OF MEDICINE, UNIVERSITY OF IOWA COLLEGE OF MEDICINE, IOWA CITY, IA, ON BEHALF OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA
The Infectious Diseases Society of America is pleased to present its views on funding for the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control to the Senate Appropriations Subcommittee on Labor-HHS-Education.
At the outset, Mr. Chairman, the Society expresses its appreciation to the Congress and the Administration for the support of the mission of the NIAID over the past several years. Although scientific opportunities in the fields of immunology and infectious disease have been greater than the resources committed to the NIAID, real progress has been made by the NIAID in achieving its goals. Our testimony will focus on specific opportunities available to the NIAID that deserve your consideration, as well as structural issues relating to the NIAID and the NIH itself. In addition, our testimony will analyze the role of the Centers for Disease Control in combatting infectious diseases, and propose improvements in the budget which, in the Society's view, must be made if the CDC's prevention and control activities can succeed.
INFECTIOUS DISEASE SPECIALISTS
The discipline of infectious diseases is a subspecialty of internal medicine and will soon become a subspecialty of pediatrics. Infectious disease specialists focus on the interaction of the patient's immune system and the various organisms (viruses, bacteria, fungi, and the like) which cause infections. The immune system is critical to the healthy functioning of the human body because it provides the necessary protection against these external invaders, as well as against certain types of cancers. Without an immune system, humans could not survive.
The Society is comprised of approximately 2,500 specialists in this field, including physicians involved in clinical and basic research in infectious diseases, as well as physicians who concentrate on clinical practice. Infectious disease specialists are the primary care physicians for patients suffering from AIDS, which attacks the entire body, not just a specific organ.
NATIONAL INSTITUTES OF HEALTH AND THE NATIONAL INSTITUTE FOR ALLERGY AND INFECTIOUS DISEASES
Analysis of the NIAID budget
The Society has reviewed the 1992 budget and past budgets and notes the following:
-The budget proposes an overall increase of 7.7 percent in spending for the various responsibilities of the NIAID. This compares favorably with budgets submitted over the past few years.
-The Society has plotted the growth of the NIAID budget over the past several years in terms of its impact on the NIAID's responsibilities prior to the AIDS epidemic. The NIAID budget has approximately tripled since it assumed AIDSrelated responsibilities, but not necessarily at the expense of other activities. Support for other, non-AIDS related, responsibilities of the NIAID has averaged about 6.5 percent of the total NIH budget over the last 10 years. -This year's budget proposes increases of 9.2 percent for non-AIDS activities, and 5.9 percent for research involving AIDS. Thus, the marvelous work of the NIAID in combatting AIDS has not been at the expense of a balanced scientific mission.
We congratulate the Congress for its wisdom in insuring a balanced support of the several important missions of the NIAID over the years.
THE FISCAL YEAR 1992 BUDGET FOR THE NIAID
Despite significant support for the NIAID by the Congress over the past several years, and despite the most progressive Administration budget proposal yet, additional scientific opportunities exist. Among them are:
Increased award rate for approved grants
Only 22 percent of approved grants for competing research projects would be funded under the proposed budget for the NIAID, an inadequate level to sustain the progress made thus far. The funding of additional competing unsolicited investigator-initiated research projects will allow the NIAID to capitalize on the exceptional basic advances in biomedical research and immunology made in the last decade and develop them to the point where clinical application becomes reality. The Society thus recommends appropriations sufficient to allow an award rate of approximately 40 percent for competing research project grants.
Infectious disease researchers are in the unique position among NIH colleagues of being able to eliminate some diseases, such as smallpox, polio, diphtheria, pertussis, and rubella, through the use of vaccines and antibiotics. Other disciplines most rely solely on education efforts to prevent disease occurrence and then only treat patients to minimize the effects Of the disease. Recently, infectious disease researchers have been able to predict with some certainty the year-to-year changes in the influenza virus and design a protective flu vaccine. Elimination of disease has tremendous potential for cost savings in terms of life years and work productivity, in addition to the obvious savings in health care costs.
Full funding for grant awards
As this Committee knows, grants awarded at the NIAID have been automatically cut by fixed percentages from the budget levels recommended by study sections. These so-called "downward negotiations" allow greater numbers of grants to be funded, but at lower levels. This practice has been demonstrated to greatly hinder researchers who must maintain prescribed personnel levels, but are subsequently forced to allocate less money for needed equipment and supplies. By the time expert
reviewers recommend funding for a research grant, the recommended level is often scaled down from the requested level. The automatic downward negotiation for every competing and non-competing grant is most damaging to this research.
Based on the proposed 1992 appropriation level for grant awards, reductions from study section recommended levels would continue at a rate of 7 to 10 percent. In the Society's judgment, appropriations for grant awards must be designed to assure full funding of these awards if our nation is to reap fully the vast benefits of these meritorious research efforts.
Increased levels for training
The Administration's budget provides no increase in the number of trainees over those supported by last year's budget. The flat-line increase for training grants is unwise. It is evident that the number of well trained biomedical researchers, particularly physician-scientists, is unacceptably low. The level of support for training should be substantially increased from that requested by the President. The NIAID appropriation should be sufficiently increased to allow about a 45 percent increase in the number of individual and institutional training awards. Attracting and retaining mid-career scientists and top new graduates is one of the most important missions of the NIAID and clearly must be expanded if the NIAID is to compete effectively with private practice and corporate research programs for stellar talent. Research and development contracts for improved vaccines
Finally, Mr. Chairman, we ask that this year's appropriation be crafted to take advantage of great strides in vaccine-development over the past few years. We ask that sufficient funds be appropriated for research and development contracts so that several vaccine initiatives-recommended under the National Vaccine Plan after careful review by vaccine experts can be initiated. In particular, we ask that the Committee insure full support of the Children's Vaccine Initiative that seeks development of a vaccine against seven or more common childhood diseases with one dose. We further ask that the Committee insure adequate funding to continue the quest for potentially less reactive pertussis vaccines. Finally, we believe that this Committee should give the highest priority to the evaluation and development of potentially effective vaccines against sexually transmitted diseases.
Mr. Chairman, there are four additional isues that will have a direct result on the ability of the NIAID to attract and retain the brightest scientific minds to bring to bear on some of the world's most dangerous diseases. We ask that in your deliberations you keep in mind the need to insure an environment that will allow implementation of long-term scientific goals and establish an atmosphere of stability, both in terms of scientific goals and in terms of long-term retention of scientists with the intellectual capacity and scientific leadership necessary to the understanding of infectious diseases. This can, in the Society's view, be best accomplished if Congressional response to this year's budget focuses on the following issues:
1. Attraction and retention of physicians and scientists Congressional reaction to the demonstrated inability by NIH to recruit and retai outstanding personnel has been by means of establishment of the Senior Biomedical Research Service, under which some 350 positions are created at income levels competitive with other opportunities. It is uncertain at this time how many of the 350 positions will actually be allocated to NIH physicians and scientists. Raising the overall number of positions to a level such that the Senior Biomedical Research Service includes at least 500 positions at the NIH will allow designation of positions for section heads, branch chiefs and other senior administrators, thereby better enabling recruitment to these positions from outside the various Institutes, where appropriate.
2. Improvement of NIH infrastructure.-Increasingly, the ability of the Clinical Center to deliver care to patients as part of research protocols has been compromised. The problem is not lack of beds, but a deteriorating facility in which heating and cooling systems do not work and replacement parts are obsolete. NIH badly needs a new hospital complex in which increasingly sophisticated clinical research can be conducted in an efficient and humane manner.
3. Earmarking without funding.-As Congressional interest in the mission of the NIAID has increased, so have Congressional specifications for the pursuit of this mission. Many times these specifications take the form of committee report language earmarking certain portions of appropriations for specific types of research. Examples include pediatric AIDS, Lyme Disease, Chronic Fatigue Syndrome, and other worthy undertakings. The Society has no quarrel with Congressional direction of the types of research that the NIAID should undertake; however, in past years, the appropriations ultimately contained in the conference report did not include sufficient funds to support Congressional earmarks from this Committee, as well as
those from the House. It is often difficult for the NIAID to support the research emanating from new directives while continuing to implement ongoing multi-year responsibilities in such areas as vaccine and drug development and natural history studies. In sum, the Society believes that Congressional direction for new activities is appropriate, but requests that Congress provide adequate fiscal support for such
4. Clinical trials and general patient care.—Mr. Chairman, there is an understandable, but incorrect, perception of many outside government that clinical trials should be accompanied by patient care activities beyond the scope of the trials themselves. It must be understood that the general delivery of patient care is beyond the scope of research protocols, and many times beyond the expertise of physicians participating in these protocols. Almost always, funding for clinical trials does not include allocations for general patient care. We ask that the Committee resist efforts to require general health care delivery within the NIH mission. Such care is critically important, but should come from sources other than the various NIH Research Institutes.
CENTERS FOR DISEASE CONTROL
Mr. Chairman, the Centers for Disease Control is critical to protection against communicable diseases. Long recognized as the world's premier institution in medical epidemiology, the CDC is charged with increasingly important responsibilities to protect the public health, including formalized prevention activities, immunization programs and programs to combat sexually transmitted diseases. New responsibilities have resulted in major increases in the overall budget of the CDC for specific activities, and we applaud Congressional and Administration initiatives in these
The Society is alarmed, however, that despite new responsibilities of the CDC, and despite a record budget for this important agency, its core activities have in fact lost support. Instead, core programs in existence since 1981 have lost ground. Ten years ago, these activities were funded at $180 million; under today's budget, they would receive only $163 million. Taking into account the so-called medical deflator, support for these programs has declined by 50 percent in the past decade. While guarding against obsolescence and revisiting the importance of all intramural programs is certainly appropriate, these figures indicate the need to insure that the ability of the CDC to respond to epidemics and other public health problems has not been diminished.
Particularly hard hit has been the Center for Infectious Diseases. This Center is the traditional resource of the Federal government for infectious disease prevention. Its activities include research to develop new or improved diagnosis, prevention, and control methods and techniques. Working with state and local health departments and private health care providers, the Center seeks to transfer and accelerate the general application of accepted prevention technologies. The Center also maintains an important capability to respond to outbreaks of many diseases that, while infrequent, may cause significant morbidity and mortality. Activities designed to identify, understand and ultimately prevent newly emerging diseases and conditions, such as Lyme the Disease and Chronic Fatigue Syndrome are dependent on the bench laboratory resources of the Center for Infectious Diseases. As we understand this year's budget, little other than pay increases are proposed for the work of this important Center.
The Society is also concerned over the decline in the ability of the CDC to respond to requests from state health departments for assistance. Traditionally, state and local health departments have looked to the CDC and its Public Health Practice Program Office for assistance in reagent standardization and reference laboratory assistance. Please review with she CDC their ability to continue to conduct these activities. Diminished responses to requests for assistance means a negative impact on human health.
Finally, Mr. Chairman, sufficient funds for CDC to purchase 100 percent of the second dose of measles vaccine on behalf of public programs must be provided. This Committee is well aware of measles outbreaks throughout the country in epidemic proportions. Some local and state programs cannot respond without additional assistance from the CDC. The Society asks that adequate funds be appropriated to allow access to the second dose of measles vaccine by every child in this country.
Mr. Chairman, we are heartened by the reemergence of the CDC Coalition, a broad-based group of public health organizations that has analyzed the CDC budget and made recommendations to you as to its adequacy. We hope you will review these recommendations carefully, with particular attention to the need for increases in programs for child health care, the work of the Epidemic Intelligence Service and