DEPARTMENTS OF LABOR AND HEALTH, EDUCATION, AND WELFARE APPROPRIATIONS FOR FISCAL YEAR 1977

MONDAY, MARCH 29, 1976.

TESTIMONY OF MEMBERS OF CONGRESS AND OTHER INTERESTED INDIVIDUALS AND ORGANIZATIONS

NATIONAL EYE INSTITUTE

WITNESSES

HON. JOHN YOUNG, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

DR. A. EDWARD MAUMENEE, PROFESSOR OF OPHTHALMOLOGY AND DIRECTOR OF THE WILMER INSTITUTE OF THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE AND HOSPITAL

Mr. FLOOD. The committee will be in order. At this time, we will hear from our distinguished colleague, Representative John Young of Texas.

Mr. YOUNG. Mr. Chairman, if the committee pleases, Honorable Pete Rodino of New Jersey, who is a personal friend and patient of Dr. Ed Maumenee, your witness, was going to present Dr. Maumenee today to the committee.

Mr. Rodino has been unavoidably detained, and it is my pleasure, Mr. Chairman, to present to the committee Dr. Ed Maumenee, on behalf of our dear friend, Pete Rodino, and commend to you your most kind attention to anything that the doctor has to say to this committee.

Mr. FLOOD. Of course, we regret under the circumstances that the distinguished gentleman from New Jersey couldn't be here, but we understand the situation, and he couldn't be better represented than by the distinguished gentleman from Texas.

Mr. YOUNG. Thank you, Mr. Chairman.

Mr. FLOOD. So we will then hear Dr. Edward Maumenee.

Nice to see you, Doctor. Everybody understands because of the time element unfortunately we have to adhere rigidly to the 10-minute rule. Regardless of the witness or what the problem is, it has to be that way. Other committees give 5 minutes.

Dr. MAUMENEE. Congressman Flood, I am deeply appreciative of the time and effort you spend in this Appropriations Committee obtaining funds for the National Eye Institute. I have testified before your committee on several occasions and know of the great work you have done and am most appreciative of the hours you spend looking into these problems for us.

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It was not until about 8 years ago through the action of Congress that we secured the National Eye Institute to start building an effective concerted program aimed at preventing blinding diseases. This was at a time when the Government was undergoing rather rigid economic restrictions, so the Eye Institute started out at relatively small funding and each year we have appreciated the efforts that you have made in assisting us and increasing our funds to tackle the problems of blindness.

I will not use your valuable time in reviewing the appalling statistics that mark blindness and cause the public to fear this only second to cancer. In a recent study made at the direction of the National Eye Institute, it was estimated that the cost of visual problems to the Government each year was $5,200 million, and I think you will agree if eye research can cut into this exorbitant annual loss that the Federal money will be wisely spent.

We hope to do this first by preventing many of the diseases and, second, by restoring sight to those people who have lost vision, and, third, by reducing the period of hospitalization on patients today. I hope to show you that we are already in the process of doing this and the savings that we will bring to the Government and to the patients far exceeding the total of $88,030,000 that we are requesting in the citizens' budget this year.

Eye research has both the good side and the complex side. The good side of eye research is that vision scientists are deeply oriented to patient care, and I am delighted to be able to tell you that as of today, a preliminary report will be coming from the National Eye Institute and information has been sent to every practicing ophthalmologist and every member of the American Diabetic Association, indicating that the use of the laser beam has been very effective in preventing blindness in the diabetic patient.

As you know, insulin controls the hyperglycemia, but the vascular problems still remain and the eye is one of the primary organs that are seriously affected by the vascular changes in diabetes, in the form of hemorrhages in the retina. By using the laser beam, a study started a few years ago at 16 medical centers and more than 1,700 patients, we have found that the use of the laser beam is effective in preventing blindness. This study was supposed to last for a 10-year period and at a cost of over $1 million a year, but the statisticians reviewing the statistics in this have already stated that the study is so successful that they are terminating at least part of the study as of his time, that is, we were treating only one eye and using the second eye as a control and the treated eye looked so much better that they are now authorizing us to go ahead and treat both eyes for this. So this is a tremendous breakthrough.

First, it demonstrates how biomedical research may be conducted safely and effectively in human patients to their great benefit and, second, it demonstrates the value of clinical trials in proving something that we only had an inkling that this was true. We knew some patients looked better after using the laser beam, but we weren't certain this was going to be true for the larger majority of the patients since some get better, anyway.

Third, it emphasizes the great need for using other clinical trials such as this in blinding eye disease.

We are now in the process of doing another study of this type, called vitrectomy. There are a number of people who have hemorrhages in the vitreous from trauma to the eye, and an instrument has been devised that is only a millimeter in diameter that reaches into the vitreous through a tiny incision, emulsifies it, gently sucks it out and replaces it with a clear solution, and through this method we have been able to bring back people who have been totally blind by clearing up the media so the patient can see.

This is at the experimental level, and we are doing a controlled study similar to that that was done in diabetic retinopathy to follow this.

Another example of the payoff has been in the field of cataract surgery. By using the microscope and sutures that are about a third the diameter of a hair, we have been able to sew the wound together so tightly we now can get patients out of the hospital within a much shorter period of time than in the past, and this saves tremendous money when you consider the cost of hospitalization now, which is in the neighborhood of $150 to $200 a day in many hospitals, and there are 300,000 cataracts at least done in this country every year.

Another field in the cataract surgery area is that we are now implanting plastic lenses in the pupilar area to replace the normal human lens after cataract surgery, so that a patient may have a cataract extraction and be able to see well without wearing the thick cumbersome cataract glasses they had to wear in the past or wear contact lenses as they have had to wear in the past to correct the vision after the cataract surgery.

There are many other examples of where we can carry things to clinical trial, such as in the retina, where myoptic degeneration is an important factor, as you will hear in a moment. Also, retinitis pigmentosa, as well as diabetic retinopathy, and many other retinal diseases are blinding many thousands and hundreds of thousands of our citizens today.

This is the clinical aspects of eye research which is good, because we can carry this right to the patient, and we can show definite benefit to the citizens immediately with the research that has been carried on.

The difficult or complex part about eye research is that there is probably no other field in medicine where so many of the difficult aspects of research are needed to solve our problems. That is, we need biochemists, immunologists, physicists, people interested in optic materials such as plastic, to use for implantation in the eye, and practically every aspect of research you can think of in medicine is either needed for the eye or the eye can be used to great advantage at least, of studying the other functions in the body.

An example of this latter is that the retina is the one part of the brain that is exposed so that you can do experiments on the retina and learn how the brain functions. There are great examples of this by studies that have been done by Dr. Hublin Weisel at Harvard, where they show the depravation of vision early in life prevented someone from seeing at a later time.

Other examples are Dr. David Robinson, in our department, using the extraocular movements, is now showing by damaging various parts of the brain he can study the plasticity of the brain. The brain is capable of rewriting itself after damage has occurred, and by using the movements of the eye he is studying how the brain goes about rewiring

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 Arc 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 blindness 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