STATEMENT OF DR. THOMAS S. EDGINGTON

Mr. Chairman and Members of the Subcommittee:

Thank you for this opportunity to speak to the fiscal 1992 funding for the National Institutes of Health and the Alcohol, Drug Abuse and Mental Health Administration. The Federation of American Societies for Experimental Biology (FASEB), which I represent, is submitting testimony on its recently developed five-year plan for restoring necessary viability and effectiveness to the NIH and ADAMHA.

I am Thomas S. Edgington, MD, Professor of Immunology at the Scripps Research
Institute, Scripps Institutions for Medicine and Science, La Jolla, California.
I am here as President of FASEB, an organization of seven scientific societies
representing more than 31,000 working scientists in the field of fundamental
and clinical biomedical research.

I wish to compliment this Subcommittee on its long-standing commitment to the
national effort in the biomedical sciences and the solutions to disease that
can only be realized from such research. The gratitude you receive from the
people of this nation and elsewhere is well deserved. You have led the support
of these endeavors which have resulted in a revolution of knowledge of human
biology, the fundamental causes and mechanisms of disease, and the translation
of this knowledge to improved diagnosis, treatment and prevention of disease.
This has fostered a level of medical care that not only saves lives and reduces
suffering, but in many ways has significantly reduced the nation's staggering
health care obligations, now estimated at more than $600 billion annually.
Effective "solution" of the diseases through biamedical research is the only
rational and effective means of reducing this cost to our people and nation.
NIH has provided updated information in a publication titled, "Cost Savings
Resulting from NIH Research Support." A continued stream of highly significant
advances have resulted from NIH supported applied research and clinical trials
which the agency makes clear would not have been possible without NIH-funded
basic research. The studies cited in the document, and the research efforts to
translate them to clinical benefit, have cost the agency about $800 million at
1989 prices, and are calculated to yield savings that range from a low of $5.2
billion to a high of nearly $6.7 billion annually, an unparalleled return on
investment fiscally, and in its human benefit, and in the strengthening of the
economic fabric of this nation.

Allow me to cite just a few examples. First, is the development of mass screening technology for neonatal hypothyroidism. This can save close to 900 newborns annually from a lifetime of arrested physical and mental development. NIH estimates that this advance, if implemented, can yield annual savings of more than $206 million with a development cost of about $1.2 million, which is a 170-fold annual return on the investment.

Second, investigators supported by grants from the NIH have developed a laserbased means of reducing the risk of severe visual loss as a result of advanced diabetic retinopathy. The potential savings are estimated at more than $2 billion annually from a research investment of about $48 million, or more than a 40-fold annual return on investment.

These two breakthroughs have their foundation in decades of fundamental,
pathbreaking research support from the NIH. This support has permitted
biomedical research throughout the nation by experts capable of elucidating the
mechanisms of these and other diseases and able to develop enabling
technologies that in a long, rational trail of endeavor have led to their
culmination in the improved lot of individuals everywhere.

Biomedical research, more than 85% of which is sponsored in the United States
by NIH and ADAMHA, has spawned biotechnology. This has resulted in a new
industry that is pioneering the application of basic biomedical science for the
benefit of mankind through the development for medical use of new recombinant
proteins as therapeutics of unparalleled efficacy and new diagnostic methods
for health care. Biotechnology also holds the promise of definitively
intervening and curing the thousands of genetic diseases that have plagued

mankind for centuries and baffled physicians in their attenpts to bring effective care to the public. Biotechnology has proven a vital and productive new industry that, in partnership with basic investigators throughout this nation, has created a new element in the economic fabric of the country, providing jobs that will benefit this nation in many ways. The U.S. is the indisputed world leader in this field, which is still in its infancy. The message is clear. Fundamental life sciences research is one of the most humane, cost-effective and growth oriented programs that is fostered by the Federal government. The support of research annually returns the investment many times over. It will continue to do so if this remarkable machine can be maintained in working order. Failure to maintain this endeavor will result in large and undesirable costs to mankind and to the economic base of this nation. We are at a critical juncture in the support and conduct of biomedical sciences in the U.S. Comfortable with a history of remarkable success, we may think it is time to turn to other more immediate issues. There are no more immediate issues than the health of the people of this nation. There is now a significant body of problems that require solutions and the research that must be done to put us on the threshold of preventing and effectively intervening therapeutically in additional diseases. These include heart and vascular diseases, diabetes and related metabolic diseases, cystic fibrosis, Alzheimer's disease, cancer and many other killing and crippling afflictions. Because of the remarkable advances in understanding of basic life sciences over the past three decades fostered by the NIH, the opportunities for progress and real solutions to ar health problems are greater today than ever before. We must have a national research program equal to the challenge and opportunity. The need is very great! The benefit is far greater!

In February, the Federation convened a Consensus Conference in which highly qualified scientists representing its seven independent constituent Societies and the Biophysical Society met to develop recommendations for NIH for 1992 and beyond, and applicable in kind to ADAMHA. Upon review of testimony from the federal agencies, and other constituencies, there developed a firm consensus that the U.S. in minder-investinga in bianedical research at a time of unprecedented opportunity and need. The conferees expressed deep concern about the precipitous decline in NIH support for new and competing grant applications of great importance, and the under-funding of non competing continuation grants through a cost-reduction process euphemistically referred to as "downward negotiations" as well as other under-funding mechanisms. The Research Project Grant mechanism is the mainstay of the national effort in biomedical research. It has been the major source of original biomedical "discovery science." without this program the solutions to critically important questions in basic and clinical medical science will not be found. The FASEB Consensus Conference, the first of its kind forthcoming from FASEB and its constituent working scientists, pointed out that in fiscal 1990 NIH funded only about 25 percent of approved applications for new and competing grants, an historic low. Only a small percent of the most excellent applications were funded, leaving urmet needs for the solution of disease. Congress also has been concerned about the decline in funded new and competing grants. It has attempted to remedy the situation by pressing NIH to fund 6,000 such grants each year through 1994, to reach the goal of a stable pool of 24,000 awards. However, the agency presently is not on track to achieve this goal.

The FASEB Consensus Conference, Biomedical Research Funding: Fiscal 1992 and Beyond, concluded that the following actions should be taken with respect to NTH funding; and comparable actions should be applied to ADAMA. • NIH should increase its priority in, and expand its support for, investigator-initiated research project grants. There should be funding of 30 percent of eligible applications each year for the next five years: fiscal years 1992 through 1996. For fiscal 1992, we recommend support of 6,143 new and competing awards with growth to 6,502 by 1996. This would result in a total portfolio of 25,470 new and non competing grants by the end of the 1996 fiscal year. Although the FASEB analysis calls for slightly more growth than envisioned by the congressional stability plan for NIH, we consider it as

consistent with congressional intent and justified by the research opportunities now available to benefit our society and help solve the fiscal problems of this nation.

NIH and ADAMHA should support the numbers of predoctoral and postdoctoral trainees recommended by the National Academy of Sciences. Trainee stipends should be increased in FY 1992 to reflect levels of experience and be adjusted for inflation thereafter. The Medical Scientist Training Program for combined MD-PhD students should be expanded to meet the needs of this nation; and NIH should create a competitive individual predoctoral training program, comparable to the one supported by the National Science Foundation, to attract more bright graduate students to careers in the life sciences and biomedical msearch.

Other elements of the NIH budget, containing an agenda of related interests, should be increased at least by the current biomedical inflation

factor, or greater depending on specific justifications. Under the FASEB plan the overall NIH appropriation would increase to $9.7 billion in fiscal 1992. The FASEB request is nearly the same as the request of the Ad Hoc Group for Medical Research Funding. We note the Ad Hoc Group recommendations provide funding for approximately one-third of reviewed research proposals.

It is important to find an effective success rate for investigator-initiated
research. The traditional peer review process cannot function constructively
at the current rate of federal support. Judgments between first-rate science
projects become arbitrary and many excellent proposals from productive
investigators doing important work are lost. This causes uncertainty to
reverberate through the system, discouraging young scientists from entering the
competition, and seasoned scientists to leave.

By funding consistently at least 30 percent of eligible grant applications, NIH
can capture the very best biomedical research, the opportunity for truly
effective solutions to disease, and restore the vitality of the biomedical
enterprise. This suggested level of support is a very conservative one,
recognizing the budgetary constraints now facing the nation. But if adopted,
it will place the u.s. in a position to capitalize on the major important
thrusts in bicmedical investigation, leads and results that otherwise will
indeed be lost. This minimal level of success of applications will provide the
certainty needed to attract the brightest young individuals to research
careers, and maintain the fragile U.S. leadership in biotechnology and related
areas of endeavor.

NIH training programs are critical to the continued excellence of the nation's
biomedical, research and industrial enterprises. Our recommendations are
designed to provide for replacing scientists who are retiring by the end of the
century, meet increased opportunities in biotechnology and other life science
areas, and make careers in the life sciences more attractive to outstanding
students, including women and under-represented minorities.
The FASEB plan will restore viability and opportunity to the NIH program and
help to maintain U.S. leadership in this critically important area.
proposes a conservative, prudent and stable support base for the most highly
meritorious biamedical research and development for the next five years; and it
proposes to adjust the rate of growth in trainees to meet generally agreed
manpower needs.

It

Congress has shown vision in regard to the value of biomedical research, and the role which NIH and its sister agency, ADAMHA, play in meeting opportunities to benefit the nation. Congress has shown its concern as well, by taking a significant step toward strengthening and stabilizing biomedical research through its support of NIH funding. The consensus plan developed by the constituency of FASEB will help to complete the task and assure continued progress in this vital enterprise. We unge its adoption.

BIOMEDICAL RESEARCH Senator ADAMS. Thank you, Doctor, very much.

I have only one question, and it is really partially a statement and partially a question. I have no question at all about the need for tying together our abilities in biomedical research with an attack on the problems of alcohol and drug abuse. I mean, we simply have to have a better method of treatment than what we are using at the present time.

Your request is $9.7 billion for NIH in 1992. That is the request. That is a 17-percent increase over 1991. If we were to go with what you have proposed, that is a 26-percent increase. You do not have to do it now in oral testimony, but you can do it in written testimony; I just want to have you give me a prioritization of how you

I think we should go about it if we cannot give you the full amount you want, because I do not know how we can. I state that not because I like it at all but as a necessary tool that this committee will probably need.

Dr. EDGINGTON. I can very simply and very briefly give you a response, if that is acceptable to you, in that the first priority is to capture a sufficient number of grants. It has never in history been below about 33 percent. This year we have fallen to 25 percent. We, therefore, recommend as the first priority funding at least 30 percent, which is about one-half of the most excellent grants to capture that science and prevent it from leaving a gap.

The second point which accounts for $500 million of that increase is a result of this 15- to 20-percent across-the-board reduction of all grants below the awarded level. We believe and we propose that as a second priority. I realize the difficulties that certainly exist in the current fiscal year and that perhaps that buyout of this arbitrary across-the-board reduction of everything below minimum levels could be bought out over a series of 2 or 3 years. The first portion, however, if you just capture the necessary science, would bring the budget to approximately $9.2 billion.

Senator ADAMS. I see. The reason I asked that question is that I am continually informed as I visit these clinics, and not just clinics but the treatment centers, the intake centers and so on, that are dealing with the drug crack, for example, that there is really no treatment available as such. In other words, the results of the effect of this drug as opposed to standard cocaine is that it very quickly goes up and down. You release the person, and they revolve back in at a very rapid rate because there are no substitutes or an approach to it.

So I hope you will prioritize by category. I am not suggesting that that is the one you prioritize because I know that alcohol abuse is probably the greatest problem we face in the country, but simply that we might have that from you because I know the committee will need that before we are finished.

Dr. EDGINGTON. Fine.
(The information follows:

LETTER FROM DR. THOMAS S. EDGINGTON

MAY 13, 1991.
Hon. BROCK ADAMS,
U.S. Senate,
Washington, DC.

DEAR SENATOR ADAMS: At the April 17, 1991 hearing of the Senate Labor-HHSEducation Appropriations Subcommittee, at which I testified on behalf of FASEB, you requested a prioritized list of the biomedical research commitments for the fiscal 1992 appropriations. The Federation's funding priorities for fiscal year 1992 specifically address the National Institutes of Health but can be applied comparably to ADAMHA and are as follows:

One, to overcome current very serious under-investment in biomedical research, NIH really will require sufficient appropriations to fund 30 percent of eligible applications for investigator-initiated research project grants. For fiscal 1997, the Federation recommends support of 6,143 new and competing grants. This is considered a minimum number for responsibly enabling research necessary for solution of the disease challenges of the nation and eventual cost reduction through effective cure.

Two, FASEB recommends full funding of new and competing grants and noncompeting, continuations at the peer-review approved levels starting in fiscal year 1992. This will require a one-time increase to compensate for the damaging effects of NIH cost containment measures taken in fiscal year 1991 and downward negotiations” in preceding years. As an alternative, a three-year stepped correction of underfunding could be considered.

Three, NIH should support the numbers of predoctoral and postdoctoral trainees recommended by the National Academy of Sciences. Trainee stipends should be increased in fiscal year 1992 to reflect levels of experience and be adjusted for inflation thereafter. Other training improvements cited in FASEB’s testimony should also be adopted.

Four, other elements of the NIH budget, containing an agenda of related interests, should be increased at least by the current biomedical inflation factor, or greater, depending on specific justifications.

The total budget recommended for NIH for fiscal year 1992 is $9.7 billion. Comparable actions should be applied to the Alcohol, Drug Abuse and Mental Health Administration.

I trust this summary of FASEB's priorities for fiscal year 1992 NIHADAMHA funding will be helpful to you and the Labor-HHS Subcommittee. Please contact me through FASEB if I may provide you with any additional information. Sincerely,

THOMAS S. EDGINGTON, MD,

President.
Senator ADAMS. Senator Gorton.
Senator GORTON. No questions, Mr. Chairman.
Thank you very much, Doctor. Your testimony was excellent.
Dr. EDGINGTON. Thank you very much.

Senator GORTON. We are sad for you, for your problem, and for the Nation.

Dr. EDGINGTON. Thank you.
STATEMENT OF DR. RICHARD G. LYNCH, UNIVERSITY OF IOWA COL-

LEGE OF MEDICINE, AMERICAN ASSOCIATION OF IMMUNOL

OGISTS Senator ADAMS. The next witness is Dr. Richard Lynch, U versity of Iowa College of Medicine, the American Association of Immunologists.

Doctor.

Dr. LYNCH. Mr. Chairman, ladies and gentlemen, I want to thank you for the opportunity to testify before this Senate subcommittee. I represent more than 5,000 members of the American Association of Immunologists. Our membership includes both basic scientists and clinicians who conduct research in the field of immunology.