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the control of eye movements; further study of the role of biological mechanisms in vision' disorders; and basic research to provide for the development of new technologically-advanced vision aids. These new initiatives would incur a first year cost of $20 million.


Question. Is the implementation of the Senior Biomedical Research Service important to the NEI? Please explain.

Answer. For the Nei, implementation of the Senior Biomedical Research Service (SBRS) is vital to sustaining a successful intramural research program. It would tremendously strengthen the Institute's ability to recruit and retain dedicated senior scientists and physicians. We are on the threshold of critical breakthroughs in understanding and treating many debilitating vision disorders. Wherever there is an opportunity to capitalize on research results obtained in the laboratory by applying them to solving clinical problems, we suffer from a lack of critical mass of research ophthalmologists. The long years of training required to be competitive and the relatively low salaries for research activities are disincentives. In our own intramural program, we are barely holding our own to take advantage of the research opportunities that are at hand. The NEI has an active laboratory program, with many results that should be applied to the care of our patients. Yet, we are unable to attract the corps necessary to do that. We continue to lose senior personnel. The Nei has not been able to recruit a new senior person for at least 15 years and have had several leave because of salary. This is a major concern. SBRS is a positive step in assuring that we are committed to retaining the best and brightest scientists and physicians.



Question. Are you supporting ongoing clinical trials of the eye complications of AIDS?

Answer. Yes, NEI is continuing to support a Cytomegalovirus (CMV) Retinitis Trial under a collaborative clinical research project entitled Studies of the Ocular Complications of AIDS (SOCA). CMV retinitis is the most common cause of vision loss in patients with acquired immunodeficiency syndrome (AIDS). The purpose of this AIDS trial is to evaluate the relative efficacy and safety of foscarnet and ganciclovir for the treatment of CMV retinitis in AIDS patients and to evaluate the effects of these treatments on survival.

We have been highly successful in recruiting patients. Recruitment began at eleven clinical centers in March 1990 and is ahead of schedule, with 162 of the 240 required patients randomized during the past eight months. Patients are assigned to one of two groups based on the location and extent of retinitis in the more severely involved eye. The first group includes patients with retinitis in the posterior region or extensive disease in the peripheral region of the retina. These patients are randomly assigned to immediate treatment with either foscarnet or ganciclovir. The second group includes patients with retinitis that is confined to less than 25% of the peripheral retina.

As a



unique feature of this trial, developed in consultation with AIDS advocacy groups, these patients are offered the option of immediate treatment, deferral of treatment until their retinitis becomes sight threatening, or participation in a randomized comparison of immediate versus deferred treatment. . All treated patients are randomly assigned to ganciclovir or foscarnet therapy. The major outcome measures for this trial are survival, retinitis progression, and drug toxicity.

Question. these trials?

Do you have enough funds in this budget to continue

Answer.. Because of the escalating cost of patient care and increased cost of doing research having out paced funding realities, the funding requirements of this trial continue to increase. However, we will continue to support the AIDS trial within the amount of funds provided in the budget.


Question. When does the National Advisory Eye Council expect to complete its next five year plan?

Answer. The National Advisory Eye Council is expected to complete its work on the 1992-1996 national plan for vision research by summer 1991.

Question. Please send a copy of this plan to the Subcommittee when it is completed.

Answer. of this plan.

We look forward to providing the Subcommittee a copy


Question. According to the congressional justification, two million Americans are known to have glaucoma, a leading cause of blindness, and an additional million people may have the disease and not know it. Are there significant applied research opportunities in glaucoma that require additional funding?

Answer. In the past, advances in glaucoma have been seriously limited, but now opportunities abound for scientists to make a concentrated attack against the disease. There are a number of significant applied research opportunities and approaches that have been developed to manage this disease that are ready to be exploited that require additional funding:

Studies that focus on preventing blindness from glaucoma and on maximizing gains in the quality of life;

Determining why the rate of open-angle glaucoma is higher and possibly a more severe disease in blacks and development of effective modalities for early detection and improved diagnosis, treatment and control of glaucoma;

Exploiting advances in molecular biology, cell biology, and immunology:

Comparing the effectiveness of immediate surgery to medical treatment in reducing visual loss in black patients with newly diagnosed open-angle glaucoma;

Evaluating the functional status and patient quality of life in a clinical trial that compares medical (drug) treatment with surgery for glaucoma; and

Determining whether treatment to lower elevated intraocular pressure prevents or delays damage to the eye in people who are at increased risk for developing open-angle glaucoma.

Capitalizing on these opportunities should offer rapid progress in determining the causes of the various forms of glaucoma and ultimately their cure.



BUDGET REQUEST Senator HARKIN. Dr. Williams, back to you now.

Your funding request of $348.5 million is 7.7 percent more than 1991. The Aging Institute enjoyed the largest percentage increase in 1991 compared to 1990 of any institute, due largely to the increases for Alzheimer's research initiated by this committee.

So, Dr. Williams, we are delighted to have you with us again today and look forward to hearing your statement. Please proceed.

Dr. WILLIAMS. Thank you very much, Senator Harkin. It is really a pleasure to present some of our recent accomplishments and outline our future directions and plans, including our use of the funds that Congress has given us.

The research funded by the National Institute on Aging is crucial for keeping suffering, disability, and medical expenditures for older Americans from increasing in magnitude with the graying of America. Older people can age and remain healthy. This gives us the challenge to identify and reduce risks leading to disease and cost of long-term care. Our ultimate goal is to assure independence and a high quality of life throughout the lifespan.

ALZHEIMER'S DISEASE Alzheimer's disease is certainly our highest priority, and we coordinate research efforts with other institutes, including the National Institute of Neurological Disorders and Stroke, and several others. This disease, as you well know, is currently responsible for disability and misery in up to 4 million older Americans and their families costing them and society an estimated $80 billion annually. A high percentage of those of us alive today will be at risk for this disease in the next century unless we can stop this terrible condition.

We are making rapid and significant progress in understanding the disease, particularly its biochemical defects and possibilities for treatment. In terms of understanding the basic biochemical defects, we learn more all the time about genetic roles. For example, a recent publication identified a specific mutation in the amyloid protein gene which is associated with the damage in Alzheimer's disease. In terms of the makeup of both the amyloid protein that causes the damage at the cellular level and the neurofibrillary tangles, which are the other major pathological finding, we are learning more almost every week about the nature of these proteins. This gives us insights into understanding how we might intervene in the production of these proteins and prevent their progress.

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