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translate these clinical trial results into direct patient care. It is estimated that implementation of the procedure can preserve the useful vision of more than 30,000 working-age Americans each year at a potential savings to the federal government of more than $400,000,000 annually. A major component of our program is professional education to encourage collaboration between ophthalmologists and other physicians involved in the care of diabetic patients.

Eye research continues to produce significant advances in the battle against diabetic retinopathy. NEI scientists recently developed the first animal model of diabetic eye disease, an important achievement that will allow researchers to accelerate studies of retinal changes associated with diabetes and of new strategies for the treatment and eventual prevention of the ocular complications. In addition, basic research at the cellular level could lead to a medical therapy to inhibit the enzyme activity responsible not only for the ocular damage, but for degenerative changes in other organs as well.

NEI-supported research is becoming increasingly important to ophthalmologists in their efforts to preserve the sight of our rapidly expanding elderly population. Americans in their retirement years are confronted with the scourge of visual loss and blindness from cataracts, glaucoma, diabetic retinopathy, age-related macular degeneration (AMD), and many other ocular afflictions to which the elderly are especially susceptible. Age-related macular degeneration is the leading cause of new blindness in people aged 65 and over in the United States, a population that will grow to 34 million by 1995. Nearly 2 million of them will have AMD, and the number will mount to 6.3 million by the year 2030 if we do not initiate a major scientific effort right now to control this disease.

AMD is a progressive degeneration of the macula, the central part of the retina that provides sharp reading vision. When the macula is damaged, the central part of images are blurred or blocked, as if a large black spot had been placed in the middle of the picture.

The National Eye Institute supports a number of basic and clinical investigations designed to achieve a greater understanding of the aging eye. The Age-Related Eye Diseases Study (AREDS) was recently initiated to follow the development and progression of cataracts and age-related macular degeneration in a group of older Americans. This multi-center clinical trial is the first large-scale attempt to track risk factors that predispose some people to AMD. Animal research and observational epidemiologic studies suggest that diets deficient in vitamins C and E, and some trace minerals, may be associated with the development of AMD. A clinical trial has been designed that could be combined with the AREDS to evaluate nutritional supplements as possible therapies for AMD.

Hope for those with retinal degenerative disease lies not only in research of AMD, but in neuroscientific investigations that are the focus of the Decade of the Brain initiative. Nearly 40 percent of all sensory input to the brain originates from the eye. An expansion of scientific efforts to understand the development and control of visual processing could greatly enhance our ability to manage a wide range of eye diseases in which the retina and optic nerve are damaged.

Two recent advances deserve particular note. Investigators have succeeded in halting retinal degeneration by transplanting retinal pigment epithelial cells in an animal model that mimics retinitis pigmentosa. The disease also has been suppressed in

this animal model in preliminary studies involving the injection into the retina of a substance called a growth factor. These are first steps down what is certain to be a long road toward a practical therapeutic strategy for degenerative retinal disease, but they illustrate both the extraordinary progress and the exciting potential that lies in NEI-funded eye research.

Mr. Chairman, revolutionary advances in scientific technology have created an extraordinary climate for unprecedented achievement in saving sight over the next decade and beyond. But these incredible new tools will be of little value without the well-trained scientists, appropriate facilities, and financial resources that are needed to exploit their enormous potential. The National Eye Institute has done an admirable job of coordinating the most productive eye research program in human history, and it must be provided with sufficient funding to accomplish the work that remains to be done.

I am grateful for the commitment that this committee and the Congress have demonstrated in the past to the NEI and its mission, and I respectfully request that you recommend approval of the Fiscal Year 1992 Citizens' Budget Proposal of $342,171,000 for the National Eye Institute. I sincerely appreciate the opportunity to present this testimony, and I shall be pleased to respond to any questions.

Thank you.

Senator ADAMS. Thank you very much, Doctor. In 1991, we had $253 million, the President said $272 million

Dr. SPIVEY. We are asking for $342.1 million.

Senator ADAMS. Now I just do not know whether we can do that, but I just wanted you to get some idea of the amounts that have moved. I am also particularly interested in your age-related macular degeneration because, certainly, I think all of us as we go through life understand that there are great changes in the manner in which we see as we go forward.

Dr. SPIVEY. Indeed. Senator ADAMS. Granny glasses for many of us and all of our other various parts.

Dr. SPIVEY. About 13 percent of people over 65 will have age-related macular degeneration.

Senator ADAMS. This is what I wanted to ask you.
Dr. SPIVEY. It affects almost everyone that one of us knows.

Senator ADAMS. I see. Thank you very much. We appreciate your testimony, and we will submit your entire statement for the record. STATEMENT OF DR. MORTON F. GOLDBERG, DIRECTOR, THE WILMER


TION FOR RESEARCH IN VISION OPHTHALMOLOGY Senator ADAMS. Our next witness is Dr. Morton F. Goldberg, director of the Wilmer Ophthalmological Institute, Association for Research in Vision Ophthalmology.

It is a pleasure to have you with us this morning, Doctor.

Dr. GOLDBERG. Thank you, sir. It is my pleasure to present the citizens' budget for the National Eye Institute for fiscal year 1992 under the auspices of Research to Prevent Blindness, Inc.

We seek your approval, Senator, of the citizens' proposal, as you just heard, of $342.1 million for fiscal year 1992. This represents only the minimum needs of vision science in pursuing only the most promising opportunities for dealing with eye diseases that sooner or later touch the lives of every family in this country and which barely meets inflationary trends.

The unfortunate reality is that more than 80 million of our citizens have diseases of the eye. The leading irreversible cause of blindness in the white population is age-related macular degeneration, whereas for black Americans it is glaucoma or high pressure in the eye. Significant impairment inflicts 3.5 percent of blacks at age 60 and soars to 16 percent at age 80 and older, and the rate climbs similarly for whites.

Given today's extended life expectancy and the rapid aging of our population, the citizens' budget provides for major initiatives in the basic and clinical sciences to pinpoint the causes of glaucoma, agerelated macular degeneration, and other blinding disorders. Americans age 65 or older will number 34 million in 1995, and close to 2 million of them will develop severe visual impairment due to agerelated macular degeneration alone unless we improve research in this area.

I wish to emphasize that prevention of blindness through appropriate research can reduce the current $16 billion spent annually for care and services for the visually disabled.

I would also like to suggest specific support of core grants which provide scientists with financing of shared facilities and shared resources. The ceilings for these grants have not been raised for many years. A modest increase in funding is required to bring National Eye Institute core grant dollar amounts in line with the current laboratory resource costs.


Finally, Senator, the high cost of not doing our research is measured not only in health savings foregone but also in the diminished economic well-being of a nation that should be and wishes to be at the forefront of international business enterprise. Visual loss is an enormous human calamity preventing this and other national accomplishments. Research to combat eye disease must be supported at a level that is in proportion to the funds appropriated for other life-disrupting national health problems.

I would be very pleased to try to answer any questions. Thank you very much.

[The statement follows:]


Mr. Chairman and Members of the Committee: I an Dr. Morton F. Goldberg, Director of the Department of Ophthalmology at the Wilner Ophthalaological Institute, Johns Hopkins University School of Medicine, here representing the Association for Research in Vision and Ophthalaology, of which I an Past President. It is my privilege to present the Citizens' Budget Proposal for the National Eye Institute for Fiscal Year 1992 under the auspices of Research to Prevent Blindness,

Each year the citizens' Committee has placed before you a solidly-documented budget proposal, derived from an exhaustive assessment of current needs and opportunities for productive research aimed at the control of blinding diseases. The National Advisory Eye Council is now completing the development of its fourth five-year plan, entitled Vision Research - A National Plani 1992-1996, achieved with the cooperation of more than 350 leaders in ophthalmic science. The citizens' Budget we present is founded on this fresh analysis of key research questions to be addressed in combatting the enormous problem of blindness and visual loss which plagues our nation.

The members of this committee will recall that, in view of the national deficit, the Citizens Committee last year submitted a budget proposal that was lower in total dollars than the previous year's request. Although our proposed budget was not approved even at that reduced level, the fiscal 1991 appropriation for the National Eye Institute (NEI) was a significant increase over the previous year's budget a reaffirmation of your sensitivity toward the crushing impact of eye disease and its effect upon human lives. That this commitment was made in the light of tremendous pressures upon the federal budget is further evidence that Congress recognizes the crucial importance of a strong vision research program to the well. being of all Americans.

I must report, however, that the confidence of the eye research community has been severely shaken by the recent erosion of federal grant support. We now seek your approval of the Citizens' Proposal of $342,171,000 for Fiscal Year 1992, which represents the minimum needs of vision science in pursuing only the most promising opportunities for dealing with eye diseases that sooner or later touch the lives of every family in this nation, and which barely meets inflationary trends in scientific costs.

The unfortunate reality is that more than 80 million of our citizens have diseases of the eye, and additional millions need corrective lenses to see clearly. We reported to you last year the initial results of an NEI-supported survey by Investigators at Johns Hopkins who estimate that nearly one million Americans are bilaterally blind, The leading irreversible cause of blindness in the white population 18 age-related macular degeneration, whereas for black Americans, it is glaucoma. Our study also documented the shocking rate of visual loss that develops

Significant impairment afflicts 3.4 percent of blacks at age 60 and soars to 16 percent at age 80 and older. The rate climbs sinilarly for whites from more than one percent at age 60 to 14.6 percent by age 80.

with age.

Given today's extended life-expectancy and the rapid aging of our population, the Citizens' Budget provides for major new initiatives in the basic and clinical sciences to pinpoint the causes of glaucoma and age-related macular degeneration, and to expand our ability to control these pernicious eye diseases. Americans aged 65 and over will number 34 million in 1995, and 1.7 million of them will develop severe visual impairment due to age-related macular degeneration. Funds are desperately needed for advanced scientific studies of degenerative factors affecting retinal cells and associated tissues; for further investigation of promising new therapeutic approaches; and for clinical studies of risk factors and of dietary supplements that have been proposed as potential therapies.

Glaucoma, a major leading cause of blindness in the U.S., afflicts black Americans at four times the rate that whites are affected. Overall, two million citizens have the disease, and another one million have it but do not yet know they are at risk of blindness. Explosive new advances in molecular biological technology now offer extraordinary opportunities for rapid progress in unmasking the causes of glaucoma, expanding our understanding of the mechanisms by which it damages the optic nerve, and providing new clues toward an eventual cure. It is imperative that funds are provided, not only to exploit these unprecedented basic scientific opportunities, but to support clinical studies to evaluate therapeutic strategies in reducing loss of sight among black patients with newly diagnosed glaucoma. Studies are badly needed to determine the relative benefits and risks of surgical operations. We must identify high risk suspects before visual damage occurs.

The Citizens' budget Includes a major expansion in research of the visual system under the Decade of the Brain initiative. Scientific Investigation of the processing of visual information, visual perception, and control of eye movement has been at the vanguard of brain research. It is therefore especially appropriate that additional funds be made available for visual neuroscientific studies to take advantage of the powerful technologies now at hand to explore the visual system with an intensity never before possible. Visual neuromuscular system disorders represent a major public health problem and are among the numerous childhood visual afflictions that mark so many for a life of extreme handicap and, too often, preventable blindness. Up to four percent of America's children suffer from amblyopia (lazy eye), strabismus (misallgned eyes), and other eye movement disorders. Expansion under the Decade of the Brain initiative of research into the causes of neurological deficits underlying these eye diseases could have enormous practical significance in their management and eventual prevention.

For it is in preventing visual loss and reducing the number of blind Americans that the $16 billion annual cost of care and services to the visually afflicted will ultimately be reduced. This nammoth burden upon our nation would be even greater were it not for the clinical trials sponsored by the National Eye Institute. These trials demonstrate the results of federally financed research as quickly as they are developed, assuring the safety and effectiveness of new therapies, and making them available promptly to practicing ophthalmologists and their patients.

Outstanding examples are the clinical research projects funded by the National Eye Institute that have succeeded in reducing by 60 percent the risk of blindness from diabetic retinopathy, the major cause of vision loss among working-age Americans. Twelve million citizens have diabetes and most of them could eventually experience retinal complications. A rigorous economic analysis has determined that a year of blindness caused by diabetic retinopathy costs the government at least $12,000 per patient. Early treatment of all eligible patients would save $108 million annually, which would recover in just one year more than twice the $48.2 million cost of the clinical trials from which the effective treatment emerged.

The progress of eye research carried out by National Eye Institute intramural and extramural investigators is validated by the millions of Americans whose eyesight has been saved. As time limitations do not permit a more detailed discussion of these achievements, a brief selection of some of the more promising recent developments is appended to this statement.

Mr. Chairman, these scientific advances have been accomplished under very stringent cost controls. The National Eye Institute has a tradition of extraordinary efficiency and economy in its operations. Its average cost for research project grants is the lowest at the National Institutes of Health, and, in terms of constant dollars, has remained at virtually the same level for nearly a decade. Core grants, which provide NEI-funded Investigators with additional support to enhance their institution's research environment and capabilities through shared facilities and resources, are relatively small. Moreover, the ceilings for these grants have not been raised for many years. A modest increase in funding is required to bring Nel core grant dollar amounts in line with current laboratory resource costs, to expand the number of core awards so that more investigators will have access to advanced methods of research, and to increase the number of research project grants.

The Citizens' Committee has called attention in previous testimony to the worsening deterioration of academic eye research facilities and the appalling lack of space that seriously hampers the development and productivity of many eye research programs. A survey conducted in 1988 by Research to Prevent Blindness, Inc., found that more than 80 of these programs need to double their space by 1995. A new survey by the Association of University Professors of Ophthalmology published in January reinforces this finding. The lack of research space and an increased need for construction grants were cited by department chairmen as major challenges to the successful development of basic and clinical science research in their departments.

We appeal to the Congress to restore funds for the construction of eye research facilities through the National Eye Institute budget. Historically, the space needs of eye research have not been adequately addressed. Total cumulative federal support for eye research construction over the entire lifetime of the National Eye Institute has amounted to a meager $15 million. We most strongly urge that $10 million, a very nominal amount, be appropriated for eye research construction and renovation in the Fiscal Year 1992 budget of the National Eye Institute.

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