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NAEC Meeting Minutes - June 13-14, 2002

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting

June 13-14, 2002

The National Advisory Eye Council (NAEC) convened for its one hundred first meeting at 8:30 a.m. on Thursday, June 13, 2002, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Paul A. Sieving, M.D., Ph.D., presided as Chair of the Council. The meeting was closed to the public from 8:30 a.m. until 12:15 p.m. for the review of grant applications. The meeting was open to the public from 1:15 p.m. until adjournment at 4:10 p.m. On Friday, June 14, the meeting was open to the public from 8:30 a.m. until 12:00 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Ruben Adler
Dr. Dean Bok
Dr. Martha C. Constantine-Paton
Dr. M. Rosario Hernandez
Dr. Gordon E. Legge
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem
Dr. J. Wayne Streilein
Dr. Larry J. Takemoto
Dr. Karla Zadnik
Lt. Col. J. Brian Reed (Ex Officio)
Dr. Marco A. Zarbin (Ex Officio)

Council member absent:

Ms. Patricia A. Cleary
Dr. P. Sarita Soni

NEI staff present:

Ms. Louise Amburgey
Ms. Diane Bernal
Dr. Mary Frances Cotch
Mr. William W. Darby
Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Judith Duff
Ms. Lois Eggers
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Mr. Paul Goldberg
Dr. Ralph J. Helmsen
Dr. Jeanette Hosseini
Dr. Chyren Hunter
Ms. Rosie Janiszewski
Ms. Tina Jones
Mr. J. Kevin Keating

Dr. Natalie Kurinij
Dr. Ellen S. Liberman
Ms. Michele Lyles
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Dr. Samuel Rawlings
Dr. Maryann Redford
Ms. Karen Silver
Ms. Karen Robinson Smith
Dr. John Paul SanGiovanni
Dr. Annie E. Schaffner
Dr. Paul Sieving
Dr. Janine Smith
Ms. Judy Stein
Ms. Marie Watkins
Mr. John Whitaker

Other National Institutes of Health (NIH) staff present:

Dr. Michael Chaitin, Center for Scientific Review
Dr. Mary Custer, Center for Scientific Review
Dr. Carole L. Jelsema, Center for Scientific Review
Dr. Brent Stanfield, Center for Scientific Review

Members of the general public present at the open session:

Ms. Tricia Bardon, American Academy of Ophthalmology
Mr. David A. Corman
Dr. Israel Goldberg, Health Research Associates
Ms. Carrie Liken, Salem Saxon, P.A.
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association

Closed Portion of the Meeting

The meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

Call to Order and Opening Remarks

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council, called the meeting to order and welcomed the Council members to the one hundred first meeting of the National Advisory Eye Council.


Dr. Sieving introduced a new member present for his first meeting of the National Advisory Eye Council (NAEC), Dr. J. Brian Reed, who is the Department of Defense ex officio member. Dr. Reed is a vitreoretinal and uveitis specialist who is also a Lieutenant Colonel in the United States Air Force. Dr. Reed received an AB in English Literature from Occidental College and an MD from the Uniformed Services University of the Health Sciences in 1990. Following an internship and residency in ophthalmology at Wilford Hall Medical Center, Dr. Reed did a uveitis fellowship at the University of California, Davis Medical Center. Dr. Reed’s outstanding research in uveitis has been recognized by the Surgeon General’s Award for Research in Ophthalmology.

Dr. Sieving noted that Council members Ms. Patricia Cleary and Dr. Sarita Soni were unable to attend this meeting.

Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Scientific Review Administrators from the Center for Scientific Review (CSR): Dr. Michael Chaitin (VISC), Dr. Mary Custer (VISA), Dr. Carole Jelsema (Chief, Molecular, Cellular, and Developmental Neuroscience Integrated Review Group). She also introduced Dr. Brent Stanfield, Deputy Director, CSR, who provided an update on recent organizational changes within the Center.

Confidentiality/ Avoidance of Conflict of Interest

Dr. McNicol reviewed policies and procedures regarding confidentiality and avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members signed a statement certifying that they were absent during such discussions.

Review of Research and training Applications

The Council considered 409 research and training applications requesting $610.0 million in total all year costs. The Council recommended 344 applications with a total all year cost of $531.4 million. Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.

Open Portion of the Meeting

Welcome and Call to Order

Dr. Sieving welcomed guests attending the open portion of the meeting. He announced that after a nation-wide search and interviews of a number of superb candidates, Dr. Sheldon S. Miller has been appointed as the new Scientific Director, Division of Intramural Research, of the National Eye Institute.

Dr. Miller comes from the University of California, Berkeley, where he is Professor of Vision Science, and Cell and Developmental Biology. His research focus has been on epithelial tissues of the eye, breast and lung. His work concerns the cellular and molecular mechanisms that determine the function and regulation of epithelia in normal and diseased states. In addition to work in membrane biophysics, he is developing animal models of retinal neovascular disease and is pursing therapeutic interventions. Along with his teaching and science, Dr. Miller brings experience in research and grant activity. He also brings critical administrative experience through work in faculty governance at UC Berkeley.

Dr. McNicol introduced Dr. Annie E. Schaffner, who has recently been appointed to the position of Scientific Review Administrator (SRA), Scientific Review Branch, Division of Extramural Research, NEI. Dr. Schaffner received a B.A. cum laude in Biology from Western Maryland College in 1973, and a Ph.D. in Biology for the University of Virginia in 1978. Following postdoctoral work in neurobiology at the National Heart, Lung, and Blood Institute, and National Institute of Child Health and Human Development, Dr. Schaffner joined the staff of the Laboratory of Neurophysiology at the National Institute of Neurological Diseases and Stroke. She published extensively on the developmental expression of neuronal antigens and the electrophysiological properties of embryonic neurons in rodent model systems. In 1998 Dr. Schaffner joined the Center for Scientific Review as an SRA in the Molecular, Developmental, and Cellular Neurosciences Integrated Review Group. Here she was responsible for Initial Review Groups and Special Emphasis Panels that reviewed applications concerned with early nervous system development, neurophysiology, and neuroinformatics.

Consideration of Minutes of Previous Meeting

The minutes of the February 14, 2002, NAEC meeting were considered and approved as submitted.

Future Council Meeting Dates

The following dates were agreed upon for future Council meetings:

September 12-13, 2002 (the 13th will be a half day meeting for program planning)
January 23-24, 2003
June 12-13, 2003
September 11-12, 2003

Council members were asked to keep these dates reserved as they make future plans and obligations.

Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the FY2002 NEI budget. The NEI received a $582.9 million appropriation, which is a 14.4% increase over FY2001. This marks the fourth year of double digit increases, and the NEI received the second highest percentage increase of the categorical NIH Institutes and Centers, lagging behind only the large increases for the National Institute of Allergy and Infectious Diseases designated for bioterrorism and for international funds for AIDS, tuberculosis, and malaria control. Despite this welcome news, the NEI is still behind in achieving the goal of a doubling of the budget over a five year period.

The $582.9 million NEI FY2002 appropriation is distributed among the Division of Extramural Research (87.6%), the Division of Intramural Research (9.5%), and Research Management and Support (2.9%).

The FY2003 budgets for the NEI and NIH are currently being considered. The administration’s budget was sent to the House on February 4, 2002. It calls for a 15.7% increase in the NIH budget, from $23.6 to $27.3 billion. The NEI budget is recommended for an 8.4% increase from $582.9 to $631.8 million. This percentage increase places the NEI near the median of the various NIH Institutes and Centers. On March 13, 2002, the NIH presented five overview theme hearings during House budget testimony. The NEI participated in the panel on health promotion and disease prevention. The Senate overview hearings were held on March 21. Citizen witness hearings were held in May, and a congressional glaucoma briefing is happening today. Congressional markup of the appropriations bill will occur this summer, with no conference committee meeting scheduled yet. It appears that the Labor/HHS appropriation will be handled very late in the budget process and there may be an omnibus bill, with continuing resolutions.

The NIH senior leadership recently held a FY2004 budget retreat in order to prepare the preliminary budget which will soon be submitted to the Department. In August, the DHHS budget is to be submitted to the Office of Management and Budget.

Amblyopia Treatment Study Outcomes

Mr. Donald F. Everett, Program Director, Collaborative Clinical Trials, discussed the recently published results from the Amblyopia Treatment Study (ATS). This was an office-based randomized trial using 200 clinical sites coordinated by the Pediatric Eye Disease Investigators Group (PEDIG) that compared atropine versus patching for the treatment of moderate amblyopia in children.

The scientific rationale for supporting the ATS is that amblyopia is the most common cause of visual impairment in children, and that most existing data on the treatment of amblyopia is retrospective and uncontrolled. The objective of the study was to compare patching and atropine as treatments for moderate amblyopia in children 3-7 years old, to develop estimates of the success rates of treatment, and to identify factors that may be associated with successful treatment. The ATS found that there was substantial improvement in amblyopic eye visual acuity with both treatments, and the difference between the two treatments was small. Improvement was more rapid in the patching group. Both treatments were well tolerated, and few patients changed treatment because of side-effects.

The ATS concluded that both patching and atropine are effective treatments for moderate amblyopia in children 3-7. Patching produces more rapid improvement and possibly a slightly better outcome; atropine has easier administration and lower cost. The initial choice of treatment can be made by the eye care provider and parent.

Ocular Hypertension Treatment Study Outcomes

Mr. Everett discussed recently published outcome results from the Ocular Hypertension Treatment Study (OHTS). The rationale for the study derives from the observation that although increased intraocular pressure (IOP) is a major risk factor for the development of primary open angle glaucoma (POAG), a potentially blinding disease, millions of Americans have increased IOP but do not have glaucoma. Thus, there has been considerable controversy over the initiation of treatment.

The objectives of OHTS were to evaluate the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the development of POAG in individuals with elevated IOP and to identify baseline demographic and clinical factors that predict which participants will develop POAG. The study found that IOP-lowering medical treatment is safe and effective in delaying or preventing POAG in ocular hypertensive individuals judged to be at moderate risk of developing glaucoma. Modest lowering of IOP (20%) reduced the incidence of POAG by 60%. Increased age, IOP, cup:disc ratio were found to be independent risk factors for the development of glaucoma among ocular hypertensive patients. Decreased central corneal thickness was found to be a powerful, previously unrecognized risk factor for glaucoma. African Americans have a higher prevalence and incidence of POAG, and OHTS data suggests that this racial effect may be due to thinner corneas and larger cup:disc ratios.

Administrative Supplements for Technology Enhancement in NEI-Funded Laboratories

Dr. Ellen S. Liberman, Lens and Cataract and Glaucoma Program Director, reported on the FY2002 initiative to provide administrative supplements to introduce innovative technologies and/or to upgrade existing facilities that support NEI-funded research projects. Seventy-three eligible applications were submitted, each representing a minimum of three NEI-funded investigators. Twenty-eight of the applications (38%) were funded, and a total of $9.8 million was invested in this program. The successful applicants represented all NEI programmatic areas. The funded requests included a number of technologies, including imaging, genomics, proteomics, electrophysiology, and animal facilities.

Role of Inflammation, Immunity, and Infection in Multifactoral Eye Disease - Concept Clearance

Dr. Richard S. Fisher, Corneal Diseases Program Director, described a proposed program initiative to encourage applications which apply an integrative study of the roles of inflammation, immunity, and infection to multifactorial eye diseases such as glaucoma, macular degeneration, diabetic retinopathy, and dry eye syndromes. Although there are individual laboratories studying either inflammation, immunity, or infection in these conditions, such efforts appear fragmented and in need of a fresh perspective. Council members endorsed the concept of this initiative.

Ocular Stem Cell Research Initiative - Concept Clearance

Dr. Fisher described a proposed program initiative to encourage applications to isolate and characterize ocular stem cells, as well as to generate reagents and techniques to characterize and separate those cells from other cell types. Such research could provide valuable models for studying ocular disease processes, creating new disease model systems, developing new therapeutics, and providing replacement tissues through understanding of the control of ocular cellular differentiation. Council members endorsed the concept of this initiative, and recommended that the program be focused largely on adult stem cells and nonhuman animal model systems.

Extramural Budget Trends

Dr. McNicol reviewed budget trends for the extramural research program in FY2002. Following the series of continuing resolutions, all continuing grants were adjusted to be funded at the committed level. The NEI anticipates funding approximately 1727 grants, compared with 1631 grants in FY2001, an increase of 96. The double-digit budget increase which the NEI received for FY2002 will permit an increase in the annual total cost of grants by an average of 5% ($14,717). It will also permit the funding of a number of new scientific initiatives. These include a shared technology enhancement supplement program, strategies to identify the genetic basis of diabetic retinopathy, novel approaches to corneal tissue engineering, an SBIR/STTR technology initiative, and enhancements to the center core grant program. In addition, the NEI will collaborate with other NIH Institutes and Centers in co-funding research opportunities in studies of ocular melanoma, diabetic complications, bioengineering, autoimmunity, computational neuroscience, global health research, and the social and cultural dimensions of health.

NIH Loan Repayment Program for Clinical Researchers and Pediatric Researchers

Dr. Chyren Hunter, Training Officer, reported on the NEI experience with the FY2002 NIH Loan Repayment Program (LRP) for Clinical Researchers and Pediatric Researchers. The purpose of this initiative is to increase recruitment and retention of highly qualified health professionals as clinical researchers by providing partial repayment of eligible educational debt. This is a trans-NIH program which is centrally administered, and information regarding the LRP is available at www.lrp.nih.gov. In this first year of the program, the NEI received ten eligible applications, which were evaluated by an external peer review panel convened by the NEI Scientific Review Branch, using NIH-wide review guidelines. Eight of the applications were in the fundable range.

Dr. Hunter indicated that in FY2003, eligibility for the LRP programs will be expanded. Applicaitons may be submitted by investigators whose research is funded by non-profit organizations other than the NIH. The NEI hopes that this policy change will increase the number of successful applicants.

Council members expressed their enthusiasm for the goals of the LRP program and encouraged staff to advertise this opportunity widely.

Indo-US Collaborative Program on Eye Research - Concept Clearance

Dr. Sieving described a proposed formal agreement between the United States and the Republic of India to expand Indo-US collaboration on vision research. The US and India have a history of sharing the common goal of eliminating preventable and treatable blindness and of successfully collaborating on research to prevent blindness. In addition to joint research projects, opportunities for collaboration include organization of workshops, identification of training opportunities for researchers, exchange of scientists, exchange of scientific information, and sharing of biological materials.

Dr. Sieving indicated that at the May 2003 meeting of the Association for Research in Vision and Ophthalmology, the NEI hosted two informal discussion sessions in which Indian and American vision scientists explored areas of mutual interest. While the formal agreement is being negotiated, the NEI will continue to stimulate increased collaboration. The broad scientific areas which could be pursued include, but are not limited to: epidemiological studies to understand the genetic and environmental factors underlying common eye diseases, genetics of inherited eye diseases, mechanisms of cataract formation and control, traditional medicine and ethnopharmacy research, and analysis and policy formulation on cost-effectiveness and public health benefits of new approaches to prevent and treat vision abnormalities. Dr. Ellen Liberman will be the extramural program director with responsibility for this initiative.

Council members indicated their enthusiasm for the goals of this initiative.

Eye Health Communication Research Initiative - Concept Clearance

Dr. Maryann Redford, Program Director, Collaborative Clinical Trials, described a proposed eye health communication initiative. NEI-supported clinical research has done much to increase scientific knowledge of the causes and treatments of ocular diseases and disorders. But the promise of research advances can only be realized when they are translated into medical practice. In order to further such translational activities, this initiative would support research which aims to apply knowledge developed by scientific discoveries to improve eye health, rehabilitate individuals with disabilities resulting from low vision and blindness, or reduce health disparities.

Council members enthusiastically endorsed the goals of this proposed initiative.

Age-Related Macular Degeneration Research Initiative - Concept Clearance

Dr. Redford described a proposed initiative to broadly expand research on the causes and treatment of age-related macular degeneration (AMD). AMD is the leading cause of blindness in the elderly in the United States, and it will have an increasingly important social and economic impact as the population ages. The NEI has funded a number of research studies to investigate the pathogenesis of the disease, understand the molecular and biochemical basis of the different forms of AMD, and improve diagnosis and treatment. Despite these advances, prevention and cure of AMD is not currently feasible. This initiative is designed to increase the pace of prevention and treatment advances by supporting a wide array of clinical research studies, ranging from pilot work to pivotal Phase III trials.

Council members enthusiastically endorsed the goals of this proposed initiative.

National Eye Health Education Program Conference

Ms. Karen Silver, National Eye Health Education Program (NEHEP), NEI, provided an update of the Sixth National Eye Health Education Conference sponsored by NEHEP. NEHEP is a partnership between NEI and 67 public and professional organizations dedicated to the prevention of vision loss and promotion of vision rehabilitation through public and professional education programs. The Sixth National Conference, held in Albuquerque, New Mexico, April 10-13, 2002, marked the 10th anniversary of NEHEP. The goal of the conference was to prepare a five year plan to increase partnership participation, strengthen networking, and develop future collaborations in the areas of diabetic eye disease, glaucoma, low vision, and Healthy Vision 2010. At the Conference working groups were formed, and a final report, “Action Plan for Vision Community” will be available in the fall of 2002. Further information is available on the NEI website, http://www.nei.nih.gov


Dr. Sieving adjourned the meeting at 3:45 p.m. on June 13, 2002.

Open Portion of the Meeting

Welcome and Call to Order

Dr. Sieving re-convened the open portion of the meeting on Friday, June 14, 2002, at 8:30 a.m. in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland

Program Planning Activities

Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, presented a staff proposal for discussion, reaction, and input from Council members. The proposal called for program planning to be done as a two step process: The first step would be the preparation of a document similar in organization to “Vision Research - A National Plan: 1999-2003”, but more streamlined. A series of program-specific panels of outside scientists would be convened to develop the broad descriptive overview, goals, accomplishment, and future directions for each area of vision research. The second step would be the initiation of a continuous planning process for emerging, cutting edge vision science. NEI staff would periodically convene focused workshops, conferences, or symposia to bring together the leading scientists in a particular area.

The staff presented a series of potential planning workshop topics to illustrate possible topics for the second phase of program planning. Council members indicated that initial steps should be taken to organize specific workshops on the pathophysiology of the optic nerve and ganglion cell disease; retinal degeneration; and the role of inflammation, immunity, and infection in multifactorial eye disease. Council members requested that the September NAEC meeting include an additional session set aside for reports back on the progress of program planning and continued discussion of future directions for the planning process.


Dr. Sieving adjourned the meeting at 12:00 p.m. on June 14, 2002.


I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Dr. Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
National Eye Institute

These minutes will be submitted for the approval of the Council at the September 12-13, 2002, meeting. Any corrections or notations will be incorporated into the minutes of that meeting. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Marie E. Watkins
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: mew@nei.nih.gov


Attachment A


(Terms end 11/30 of the designated year)

Dean Bok, Ph.D. (02)
Professor of Neurobiology and Ophthalmology
University of California, Los Angeles
Los Angeles, CA 90095-1763

Patricia A. Cleary, M.S. (02)
Senior Research Staff Scientist
The George Washington University
Rockville, MD 20852

Martha C Constantine-Paton, Ph.D. (03)
Professor of Biology
Massachusetts Institute of Technology
Cambridge, MA 02139

M. Rosario Hernandez, D.D.S. (02)
Associate Professor of Ophthalmology
Washington University
St. Louis, MO 63110

Gordon E. Legge, Ph.D. (03)
McKnight Distinguished University Professor of Psychology
University of Minnesota Twin Cities
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (01)
Senior Partner
Salem, Saxon, and Nielsen, P.A.
Tampa, FL 33602

P. Sarita Soni, O.D. (03)
Professor of Optometry & Visual Science
Indiana University
Bloomington, IN 47405

J. Wayne Streilein, M.D. (04)
President and Director of Research
Schepens Eye Research Institute
20 Staniford ST
Boston, MA 02114

Larry J. Takemoto, Ph.D. (02)
Professor of Biology
Kansas State University
Manhattan, KS 66506

Karla Zadnik, O.D., Ph.D. (04)
Professor, College of Optometry
Ohio State University
Columbus OH 43210-1240

Department of Defense Representative

Lt. Col. J. Brian Reed, M.D.
Chief, Vitreoretinal and Uveitis Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103
Ex Officio Members

Tommy G. Thompson
Department of Health & Human Services
Washington, DC 20201

Ruth L. Kirschstein, M.D.
Principal Deputy Director
National Institutes of Health
Bethesda, MD 20892


Paul A. Sieving, M.D., Ph.D.
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary

Loré Anne McNicol, Ph.D.
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892