itself, and the cerebellum is the workshop of repairing some of these functions in the brain. [Dr. Maumenee's biographical sketch and complete statement follows:] A. Edward Maumenee, M.D. is professor of ophthalmology and director of the Wilmer Institute of the Johns Hopkins University School of Medicine and Hospital. He is past president of the American Academy of Ophthalmology and Otolaryngology; the section of ophthalmology of the American Medical Association; the Association for Research in Vision and Ophthalmology; and the Pan American Association of Ophthalomogy. He is founder and past president of the Association of University Professors of Ophthalmology, and is a member of the scientific advisory panel of Research to Prevent Blindness. Inc. (RPB). Dr. Maumenee serves as ophthalmic consultant to the Surgeon General of the U.S. Navy. Mr. Chairman, and members of the committee. I know that you and your congressional associates are deeply concerned with the enormous cost of the delivery of health care in this country. I also recognize the great responsibility you have to put into proper perspective the varied demands for Federal Government support of medical research aimed at the prevention of disease and disability. I have appeared before this subcommittee on a number of occasions, presenting the case for eye research. I am grateful for the courtesy you have extended to me and for your efforts on behalf of this area of health research that was all but ignored when the National Institutes of Health were established. It was not until 8 years ago that we were able, through the action of the Congress, to secure a National Eye Institute and start building an effective, concerted program aimed at the prevention and treatment of blinding diseases. As far as funding was concerned, we began at the bottom, and at a time when rigid economies were being exerted on Government spending. The National Eye Institute has never experienced the abundance enjoyed by the older Institutes, although it has shared with them the problems of tight money and rising inflation. So we are most thankful for the encouragement and support you have given the Institute as it attempts to develop an adequate fiscal base for the fulfillment of its mission. I will not use your valuable time in reviewing at length the appalling statistical evidence that marks blindness and serious visual disability as a national calamity. I will place these statistics in the record, should you wish to review them. However, it is especially pertinent to the decisions of this committee to note the enormous financial loss resulting from the ravages of eye diseases-$5.2 billion every year according to recent testimony by the Director of the National Eye Institute. I think you will agree that if eye research can cut significantly into that exorbitant annual loss, then this is a wise use of Federal funds. I am pleased to report that this is now happening. Vision research is more than paying its own way: first, by preventing many with serious eye disease from going blind; second, by restoring sight already lost; and third, by greatly reducing the patient's period of hospitalization, recuperation and time away from normal activity and employment. The resultant saving to the patient, the government and the taxpayer in one year far exceeds the total of our budget request of $88.030.000. Vision science is deeply oriented to the patient. In no other field of medicine are the results of research so quickly and so effectively translated into patient care and the management of disease. At this moment, for instance, every practicing ophthalmologist in the country and every physician member of the American Diabetes Association has been sent a preliminary report of a National Eye Institute clinical study that may affect the lives of 300.000 Americans whose sight is threatened by diabetic retinopathy. This is the most rapidly growing cause of blindness in the United States, and one of the devastating consequences of diabetes. Five years ago-because the Congress appropriated the money-it became possible to begin nationwide clinical trials of treatment techniques for this disease involving the use of powerful beams of light. Research had adapted the Argon Laser and Xenon Are Light Beam for use in sealing off destructive retinal vessels and hemorrhages in the eye. But there was great uncertainty as to their true value, and even fear that the treatment-called photocoagulation-might be as damaging as the disease process. The NEI-funded Diabetic Retinopathy Study was instituted to resolve these questions of safety and effectiveness. It needed the commitment of 16 medical centers and more than 1,700 patients for a 10-year investigation at a cost of $1 million a year. Today, in only half that time, there is sufficient evidence for the study group to say that this treatment can substantially reduce the risk of biindness in many patients at specifically defined stages of severe retinopathy. Moreover, the evidence is so convincing that the investigators have changed their original protocol, in which one eye of each patient was not treated because of the uncertainty of its value. They are recommending that initially untreated eyes now be considered for treatment where conditions warrant it. These are exciting results-and they are from very preliminary findings, the first report issued by the study group. But I think they demonstrate several points that are worth the consideration of this committee. First, they demonstrate how biomedical research may be conducted safely and effectively in human patients, and to their great benefit. Second, they demonstrate the great value of clinical trials in speeding the movement of research results from the laboratory to the patient. Third, they indicate the need for far greater emphasis on such trials in other areas of eye research which I shall mention. The dissemination of these findings is an exemplary instance of good communication between the research group and the practicing physician, for which the National Eye Institute must be commended. With the cooperation of the American Journal of Ophthalmology, the preliminary report already is in the hands of those physicians most concerned with treatment, several days before its official public announcement. If given the opportunity, eye research will perform with equal excellence in other areas now under investigation. Vitrectomy, for instance, is a recent development of research that now permits the eye surgeon to remove the gel-like vitreous that fills the center of the eye. This normally clear substance has blinded thousands by becoming clouded as a result of retinal hemorrhaging and other disease states. Until a few years ago such conditions were considered inoperable and the result was permanent blindness. We are now restoring sight to many of those so blinded through the use of an extraordinary surgical instrument which reaches into the vitreous through a tiny incision, emulsifies it, gently sucks it out and replaces it with a clear solution. The device was developed at the University of Miami under a grant from the National Eye Institute and with early impetus and financial assistance fro Research to Prevent Blindness, Inc. (RPB). The full potential of this instrument has yet to be realized. We have high hopes for its use in preventing other forms of blindness before sight is lost. The most effective method for exploring these possibilities is through the medium of nationwide clinical trials. The framework for such vitrectomy studies is already being constructed by the National Eye Institute. Like the Diabetic Retinopathy Studies, they can take place only if the Congress is ready to provide the necessary financial support. As the benefits of such revolutionary achievements in eye research reach into the patient population, it can be expected that many will be able to lead normal, productive lives who otherwise would find themselves dependent upon family, government and philanthropic assistance. An outstanding example of research payoff is recent work in cataract. More than 300,000 cataract operations are performed in this country every year, with better than 98 percent success. This is a tremendous accomplishment when one considers that the alternative for these patients would be loss of useful vision or blindness. In recent years cataract surgery has been made safer and far more effective through the development of microinstrumentation, removal of the lens through freezing techniques, and splendid advances in surgical materials and procedures. Where it once was necessary for the patient to remain immobilized for days during the healing process, he now returns home in a few days and quickly resumes normal activity. When one considers the staggering cost of medical care today it is obvious that, by shortening hospital stay and recovery period, eye research is saving the American people many millions of dollars. But I would like to correct any impression that successful removal of the lens is the definitive answer to the cataract problem. The absence of the natural lens in most cases results in a drastic change from normal perception, to which many people cannot adjust. The aged, the arthritic and otherwise disabled often are unable to manipulate a contact lense or cannot tolerate it. Researchers have long cherished the idea of replacing the natural lens with a permanent artificial implant in the normal lens position, which would give maximum correction of vision. Unfortunately, finding a material that would be tolerated by and compatible with human eye tissue posed a seemingly insur mountable obstacle. During World War II a British ophthalologist, Professor Ridley, observed that among war injuries he treated were many in which pieces of plastic from shattered airplane "blister" windows had lodged in the eyes of fighter pilots and crewmen—but were well tolerated in the eye. He began experimenting with this material, developing and inserting the first plastic intraocular lens implants. Unfortunately, these lenses failed to remain in place and eyes were lost. Others took up the challenge, among them Drs. Strampelli of Italy and Barraquer of Spain, who modified the lenses and sought better ways to secure them in position. Here in America we remained cautious, having seen too many cases of corneal edema and lost eyes resulting from these efforts. Then, 15 years ago, Dr. Binkhorst of Holland implanted an acceptable plastic lens inside the eye by clipping it to the iris. As time progressed and his cases showed few late complications, his success has attracted intense interest among American ophthalmologists. New materials are being sought and new techniques investigated, and intraocular implants are now occurring here with some frequency. I believe this new new development requires extensive testing under controled conditions, so that its value may be properly assessed. The National Eye Institute is the appropriate agency for the implementation of clinical field trials such as those we have mentioned in "Diabetic Retinopathy and Vitrectomy." I urge the support of the Congress in making such studies possible. I wish to make it clear, however, that advances in therapy are no substitute for the prevention of eye disease. Our joy at saving the sight of an increasing number of patients should not obscure the fact that almost all blindness in the United States is the result of diseases whose causes are unknown to science. It is estimated that 1,177,000 Americans are afflicted with disorders of the retina, which include retinal degeneration, retinal detachment, retinitis pigmentosa as well as diabetic retinopathy and other diseases. We do not now know how to prevent any of these. And the numbers of the afflicted are growing as our aged population increases. The cost of cataract surgery, including medical, hospital and followup care, has been estimated at $720 million a year in this country alone. While it almost always restores sight that would otherwise be lost or severely impaired, cataract surgery is certainlly not the utimate solution to this yet unpreventable disease. The most hopeful aspect of our efforts to deal with eye problems is our increasing ability to observe and study the nature and function of eye tissue, both in the laboratory and in the living person. At my own institution a fluorescein dye technique was introduced which has been almost universally adopted for visual observation and photography of the flow of blood through the tiny vessels of the retina. We have now developed a still more advanced technique which permits the simultaneous photography of blood flowing through the separate but interrelated circulatory systems of both the retina and its underlying vascular tissue, the choroid. Such advances have the double advantage of aiding both the diagosis of disease and the study of some of the eye's most basic functions. Another of our researchers has developed an experimental model of diabetic retinopathy very close to the human disease. With this he has discovered the presence of a protein in the retina during the abnormal growth of blood vessels, but which is not present in the normal state except prior to birth, when the retinal system is being formed. His model has provided a method for the systematic study of basic factors that cause retinal vessels to proliferate-the most destructive characteristic of diabetic blindness. Researchers have now produced in laboratory animals experimental sugar cataracts similar to those found in human diabetes and galactosemia. They have pinpointed a specific enzyme as the causative agent and have even succeeded in slowing down the development process by the use of chemicals that inhibit the enzyme activity. It has also been possible to develop a reasonable explanation of how cataracts develop. Research has discovered that the lens proteins are transformed in their cataractous state, becoming so large that they act as a barrier to light. It has been demonstrated that water may be absorbed into the lens. causing distortion within its tissues so that light is disrupted and dispersed, rather than passing through uninterrupted. These are findings that approach the very core of the cataract problem-the chemical mechanisms that cause their formation. If these mechanisms can be halted or even delayed for a period of years in the human eye, the financial return from this kind of basic research will be enormous. Since most of us will experience the onset of cataracts if we live long enough, each of us has a personal stake in these important studies. To put eye research into proper perspective, we must realize that blindness is not itself a disease, but the ultimate result of at least five distinct categories of eye disease, each involving different kinds of tissue, different functions, different disease processes and different research approaches. Cataract is vastly different from retinal disease. If we were to find a preventive for one tomorrow, we might be no closer to solving the problems of the other. Glaucoma, for instance, involves the transport of essential fluids into and out of the eye's anterior chamber, just in front of the lens. If that flow is not in balance, pressure builds up inside the eye and may eventually destroy the optic nerve. We are still not sure how that process takes place, although we have had good success in reducing the excessive pressure, primarily through the use of drug therapy. Hundreds of thousands of Americans depend upon daily administration of eye drops to stabilize their intraocular pressure and avoid blindness. This is an outstanding instance of the quick application of eye research to the care of large numbers of patients. New drug delivery systems are being developed, including a soft, pliable plastic wafer that can be placed under the lid of the eye where it releases medication over an extended period of time, so that daily application of drops becomes unnecessary. Meanwhile, new surgical procedures have been developed that effectively correct some forms of glaucoma. But, again, therapy is not the ultimate answer. Drugs are expensive and inconvenient. If the disease is not discovered in time, the damage already done is irreversible. It is vitally important that we understand the processes that lead to loss of vision, so that they may be prevented. The answers lie in far more intensive eye research-a science that we feel has only begun to realize its potential for serving the American people. If time permitted, I could tell you of advances in corneal disease, where successful tissue transplants occur daily and knowledge of the body's immune mechanism is being vastly extended. Most recently, an antibody has been developed into which donated corneal tissue is dipped, with the result that the rejection process is inhibited. A new drug, Ara-AMP, is expected to provide a powerful weapon against intractable herpes infection of the eye, the major cause of corneal blindness. Corneal prostheses are giving sight to many blinded by disease and accidents. Huge strides are being made in saving the sight of children with motor disorders of the eye, with strabismus and amblyopia and genetic diseases. We are exploring the entire visual system, from the cornea to the visual cortex of the brain, learning at last about the almost limitless forms of insult that may occur anywhere along the visual tract which result in visual loss and blindness. Last year the National Advisory Eye Council produced a planning report which analyzed the state of vision research and outlined recommendations for its future development. The proposed budget presented here would begin the implementation of those recommendations in a manner that will multiply the effectiveness of outstanding investigators, move research findings quickly into the mainstream of patient care, accelerate the search for preventives, and reduce the staggering cost of eye care and visual disability. With such goals in mind, the citizens' budget proposal comprehends the allocation of $23,500,000 for specialized clinical research centers and core center grants. These would tie together the often fragmented efforts of vision scientists working in related areas of research; but separated by the inflexibilities of project grant administration. The program would draw together established investigators in basic and clinical research to work cooperatively toward mutual research goals. It would provide continuity and stability to centers of excellence, creating an ideal environment for patient care and scientific investigation. It would establish a geographic network of research centers capable of fast, objective testing of creative concepts, speeding their application to the needs of patients. In order to set realistic research priorities and properly assess the effectiveness of the total research effort of the Eye Institute, the advisory council report has stressed the importance of amassing adequate statistical data, and that recommendation has been incorporated into our proposed budget. The planning report has drawn a blueprint for combating blindness. It remains now for the Congress to provide the financial support necessary to get the job done. I therefore urgently request that this committee recommend approval of the citizens' budget request of $88.030,000 for the National Eye Institute for fiscal year 1977. It contemplates expenditures in the following program areas: For retina land choroidal disease, $32,469,000; for corneal disorders, $12,336,000; for cataract, $7,111,000; for glaucoma, $10,580,000; for sensory-motor disorders and rehabilitation, $15,357,000; for intramural laboratory and clinical research, $6,155,000; and for research management and program services, $4,022,000. Financial tables related to this proposed $88,030,000 budget are appended to my statement. I deeply appreciate the opportunity to appear before this committee, and welcome your questions. Thank you. 73, 853, 000 (e) Training---- Total grants---- 2. Direct operations: (a) Laboratory and clinical research_-_. (b) Research and development contracts--- (c) Biometry, epidemiology, and field services_--- (d) Research management and program services_. 6, 155, 000 4, 000, 000 1, 586, 000 2, 436, 000 14, 177, 000 88, 030, 000 (a) 132, 469, 000 (b) 12, 336, 000 (c) 17, 111, 000 (d) 10. 580, 000 1 1 (e) 15. 357, 000 6, 155, 000 4,022, 000 88, 030, 000 1 Includes the following amounts for specialized clinical research centers and care center grants: (a) $10.043,000; (b) $3,400,000; (c) $2,354,000; (d) $3,297,000; (e) 4,406,000. Total: 23,500,000. THE HUMAN AND ECONOMIC COST OF VISUAL IMPAIRMENT IN THE UNITED STATES Eye disease is feared by Americans more than any other affliction, save cancer. Ten million American citizens-1 of every 20-suffer from significant, uncorrectable visual impairment; 3 million have cataracts; 1 million have glaucoma ; 1,177,000 have retinal and choroid disorders. Five hundred thousand are legally blind and eligible for special financial assistance. One and one-half million are functionally blind-they cannot read a newspaper with either eye, even with the aid of glasses. Three and one-half million have only partial vision. More than 500,000 major eye operations are performed in the United States every year. More than 10 percent of all patients seen at the Nation's medical hospitals are eye patients. The annual cost of visual problems to the Nation is $5.2 billion.1 More than 90 percent of all blindness is the result of eye disease. Less than 3 percent is caused by injuries and 3 percent from poisoning. Mr. FLOOD. Thank you, Doctor. Next we will have Mrs. Sylvia Rachlin, the executive vice-president, Myopia International Research Foundation, Inc. 1 From a recent study conducted for the National Eye Institute. |