tissue that sometimes blocks the surgically created channel, thereby necessitating another filtering operation that has even less chance of success. Early study results show that one year after surgery, only 27 percent of the patients who received 5-FU needed reoperation, compared to 50 percent of those who had surgery alone. Moreover, in the surgery alone group, only about one-third could maintain satisfactory intraocular pressure without medications, compared to two-thirds of those receiving 5-FU. Furthermore, of the patients needing medication, those in the 5-FU group needed lower doses and fewer types of medication than did those who had surgery alone. The next steps are to study the long-term safety and efficacy of the drug. To improve the outcome of treatment for diabetic retinopathy, which treatens the sight of the 11 to 12 million Americans with diabetes, the NEI initiated the Early Treatment Diabetic Retinopathy Study (ETDRS) in 1979. The ETDRS was designed to investigate three questions: Is laser treatment effective for diabetic macular edema, which is a swelling of a part of the retina that provides sharp, straight-ahead vision? When in the course of the disease progress is the best time to begin laser treatment for diabetic retinopathy? Does aspirin treatment alter the progression of diabetic retinopathy? The controlled, multicenter clinical trial, begun in 1979, enrolled 3,711 patients at 22 centers. Final results support earlier study findings that laser treatment of macular edema reduces by half a patient's risk of visual loss. The study also showed that, if a patient with early diabetic retinopathy is followed regularly, laser treatment may be safely deferred until the disease progresses to a more advanced stage, thereby sparing the patient from the possible siade effects of treatment until sight is threatened. It also showed that although 650 mg of aspirin taken daily did not prevent or slow the progression of retinopathy, neither did it increase the risk of progression. This latter finding may be important to diabetic patients who have twice-the-normal risk for developing cardiovascular disease, which might require daily aspirin therapy. In closing, I would like to describe work in two areas of research that are important for future vision research. We know that certain eye diseases are related to the aging process, but we lack accurate and current information about the prevalence of blindness and visual impairment among older people. The Baltimore Eye Survey was funded to provide this information by studying a large, multiracial population that could serve as a model for many urban areas in the United States. The survey determined the prevalence of blindness and visual impairment among blacks and whites 40 years and older who come from comparable socioeconomic settings. A population-based sample of 5300 blacks and whites received an ophthalmologic screening examination that included detailed visual acuity measurements. this sample, the researchers estimate that more than 3 million Americans 40 years or older are visually impaired and 890,000 of these are bilaterally blind. From The survey found that prevalence of blindness and visual impairment in blacks was double that of whites. The rates of vision loss for both groups rose dramatically with age, but there was no difference between males and females in the rise. The researchers also found that more than 50 percent of the subjects had improved vision after refractive correction, some improving by three or more lines on the eye chart. In the older segment of the population, the need for cataract surgery will constantly expand as more and more people enter their 70s and 80s. Currently, cataracts cause visual disability for about 20 percent of Americans in their 70s and for about 50 percent for those in their 80s. Americans annually spend about $3.5 billion to have cataracts removed. We calculate that if some way could be found to delay the need for surgery by just 10 years, the annual number of cataract operations could be cut in half at a significant annual savings to the Nation. Cataract prevention, therefore, is an important NEI research goal. Currently, several drugs are showing promise for slowing or halting the development of cataract, but, until recently, we have lacked a reliable method for classifying subtle differences in lens opacities. Such a method would be essential for monitoring the effectiveness of a candidate drug. Now NEI scientists have developed a Lens Opacities Classification System that makes it possible to grade/classify cataracts accurately and pinpoint fairly subtle lens changes. Because the new system is easy to use and users reach almost perfect agreement on cataract classification, it should also be valuable for field studies of cataracts in various parts of the world. Investigation of questions about whether altitude or sunlight affect cataract development may provide important clues about mechanisms involved in cataract development and may lead to methods of prevention. These are but a few examples of how our investment in vision research is producing significant returns in clarifying the underlying process of several blinding eye disease and in advancing our ability to prevent blindness. Mr. Chairman, the FY 1991 budget request for the National Eye Institute is $247,392,000. I will be happy to answer any questions. BIOGRAPHY OF DR. CARL KUPFER February 9, 1928. New York, New York. Education: A.B., Yale Univ., 1945-48. M.D., The Johns Hopkins Medical School, 1952 Certified. Amer. Bd. of Ophthalmology, 1958. Professional History: Internship and Assistant Residency, Wilmer Professional Organizations: Amer. Physiological Society; Assoc. for Research in Vision and Ophthalmology; American Academy of Ophthalmology; American Ophthalmological Society; Pan American Ophthalmological Society; Johns Hopkins Univ. Soc. of Scholars; Member, Inst. of Medicine, National Academy of Sciences. Honors and Awards: The Secretary's Special Citation, Dept. of QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Thank you very much, Dr. Kupfer. There will be some additional questions from various Senators which we will submit to you for your response. [The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:] QUESTIONS SUBMITTED BY THE SUBCOMMITTEE NATIONAL EYE HEALTH EDUCATION PROGRAM Question. In the fiscal year 1990 report, the Committee urged your Institute to push for full implementation for a National Eye Health Education program. For example, I understand that 50 percent of diabetic patients are not receiving available treatment in order to maintain good vision. Glaucoma is another chronic situation which can be effectively managed if people are aware of the need to seek help. What is the status of this Health Education program? Answer. This past year has been a busy and productive one for the National Eye Health Education Program (NEHEP). Some of the activities recently undertaken include the following: One of the NEHEP's four operating principles is to extend the reach and effectiveness of the program through the use of intermediaries--professional, voluntary, and civic organizations; other government agencies; and private industry groups with an interest in eye health. This approach maximizes the amount of resources available for the program because the private sector can provide support for the development of materials and delivery of educational messages to NEHEP target audiences. To help build NEHEP's intermediary relationships, the NEI hosted a national Planning Conference last March, with more than 65 participants representing a diverse group of 35 professional, voluntary, and government organizations as well as pharmaceutical companies. Conference participants offered many recommendations for NEHEP activities, on which NEI staff have been working. To guide the program, recommendations have been developed for the establishment of a formal, two tiered, advisory structure consisting of a small Planning Committee and a larger group called the NEHEP Partnership. The Planning Committee includes members with expertise in key NEHEP program areas who will provide advice on the development, implementation, and evaluation of NEHEP activities. The first Committee meeting was held in January 1990, at which NEI staff presented recommendations for NEHEP projects currently in development and those planned for the future. The group endorsed all of these recommendations, including plans to conduct a national survey of public knowledge, attitudes, and practices about eye health; development of a pilot test for a national toll-free telephone information service to answer the public's questions on eye health; and selection of the first two target audiences at which to direct NEHEP activities. The audiences are: people with diabetes to receive messages about early detection and timely treatment of diabetic retinopathy, and blacks over age 50 who are at high risk for glaucoma to receive messages about early detection and appropriate treatment of this disease. The second tier of the advisory structure, the NEHEP Partnership, will consist of representatives from professional associations, voluntary and civic organizations, and other groups concerned with eye health and which represent important NEHEP target audiences. These organizations will be invited to join the program soon. With the help of the Planning Committee and the Partnership organizations, the NEI is developing strategic plans to reach the first two designated target audiences with eye health education messages and materials. A major objective of the NEHEP is to serve as a national resource for information about eye health education programs and materials. By serving as such a resource, the Program can avoid costly duplication of effort and can contribute to the exchange of ideas. and information. To this end, an eye health education subfile has been established for the Combined Health Information Database, which represents a cooperative effort of many Federal government agencies. The eye health subfile became accessible in January 1990, and new information will be added on a quarterly basis. Because it is critical to evaluate whether the expenditure of Federal funds for the NEHEP has an impact on the public's health, we are building a research and evaluation component into the Program. As the first step, a research project has been planned that will provide baseline data on the knowledge, attitudes, and practices of NEHEP target audiences regarding health care and eye disease. As part of this research effort, a series of focus group discussions will be conducted with small groups representing the two initial target audiences: blacks over age 50 who are at risk for glaucoma and people with diabetes and their families. The focus groups will help obtain insight into what these populations know about the risk of blindness from glaucoma and diabetic retinopathy and how the NEHEP can best deliver messages to encourage appropriate eye care. The focus group discussions will also provide information important to the development of the national survey. While these projects have received the greatest emphasis during the past year, other information activities relevant to the NEHEP have also been undertaken. Two important projects involved disseminating recently announced results of two NEI-supported clinical trials, one that studied treatment for diabetic retinopathy, the Early Treatment Diabetic Retinopathy Study (ETDRS), and one on glaucoma treatment, the Fluorouracil Filtering Surgery Study. For each trial, NEI staff prepared a variety of information materials for both national distribution and dissemination from participating clinical centers. Staff also made presentations at meetings of the of investigators for each trial about how to conduct publicity activities in their cities that would mesh with national media activities. Το For the ETDRS study, an exhibit was developed and staffed at the annual meetings of the American Academy of Ophthalmology and the American Academy of Optometry and a fact sheet for patients was written and distributed that explained the study's conclusions. make certain that all ophthalmologists treating diabetic patients knew of the ETDRS conclusions, a clinical alert letter was prepared and, with the assistance of the American Academy of Ophthalmology, mailed to 22,000 ophthalmologists around the world. NEI staff also recently participated, at the invitation of the National Society to Prevent Blindness, in activities proclaiming the week of November |