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NAEC Meeting Minutes - January 23-24, 2003

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting

January 23-24, 2003

One Hundred Third Meeting

The National Advisory Eye Council (NAEC) convened for its one hundred third meeting at 8:30 a.m. on Thursday, January 23, 2003, 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 1:15 p.m. for the review of grant and cooperative agreement applications and for the review of the NEI Intramural Research Program. The meeting was open to the public from 1:30 p.m. until adjournment at 4:34 p.m. On Friday, January 24, 2003, 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. Roy W. Beck
Dr. Suraj P. Bhat
Dr. Martha C. Constantine-Paton
Dr. Gordon E. Legge
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem

Dr. Lois E. Smith
Dr. P. Sarita Soni
Dr. J. Wayne Streilein
Dr. Janey L. Wiggs
Dr. Karla Zadnik
Lt. Col. J. Brian Reed (Ex Officio)
Dr. Marco A. Zarbin (Ex Officio)


NEI Staff Present:

Ms. Louise Amburgey
Mr. Kelley Burdette
Dr. Deborah Carper
Dr. Mary Frances Cotch
Dr. Bruce Cumming
Ms. Chris A. Davis
Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Mr. Donald F. Everett
Dr. Richard S. Fisher
Dr. Ralph J. Helmsen
Ms. Jean Horrigan
Dr. Jeanette Hosseini
Dr. Chyren Hunter
Ms. Tina Jones
Mr. J. Kevin Keating

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 Robinson Smith
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Judy Stein
Ms. Marie Watkins
Ms. Cheryl Wild
Mr. John Whitaker


Other National Institutes of Health (NIH) Staff Present:

Dr. David Armstrong, Center for Scientific Review (CSR)
Dr. Michael Chaitin, CSR
Dr. Mary Custer, CSR
Dr. Margaret Snyder, Office of Extramural Research, OD
Dr. Marcia Steinberg, CSR

Other Federal Government Staff Present:

Dr. Wylie Chambers, Food and Drug Administration


Members of the General Public Present at the Open Session:

Dr. Michael Danciger, Loyola Marymount University
Mr. Patrick G. Eddington, American Academy of Ophthalmology
Ms. Carrie Liken, Salem Saxon, P.A.
Mr. Edward H. McManus, National Alliance for Vision and Eye Research
Mr. Robert Rupp, Associations for Research in Vision and Ophthalmology
Ms. Lois Schoenbrun, American Academy of Optometry
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association

Thursday, January 23, 2003


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 third meeting of the National Advisory Eye Council. He introduced four new members who are joining the Council at this time:
Dr. Roy Beck is a clinician scientist, active in clinical trials research such as the Pediatric Eye Disease Investigator Group. He trained in neuro-ophthalmology and in epidemiology, and is currently the Executive Director of the Jaeb Center for Health Research, in Tampa, Florida. He also holds appointments as a Clinical Professor of Ophthalmology and an Adjunct Professor of Epidemiology and Biostatistics at the University of South Florida.

Dr. Suraj Bhat is a lens researcher who has made major contributions to our knowledge of the expression of crystalline genes. He is broadly interested in the molecular genetics of development of the visual system, including the retinal as well as the lens. He serves as an Associate Professor of Ophthalmology at the Jules Stein Eye Institute in Los Angeles.

Dr. Lois Smith is a clinician scientist at Children’s Hospital in Boston, who is an Associate Professor of Ophthalmology at the Harvard Medical School. She trained as a pediatric ophthalmologist and has published extensively in the field of retinal neovascularization.

Dr. Janey Wiggs is a clinician scientist on the Glaucoma Consultation Service at the Massachusetts Eye and Ear Infirmary of Harvard Medical School. She has trained in ophthalmic genetics and provides the leadership to three major NEI-funded studies of genetic factors that predispose to various forms of inherited glaucoma.

Dr. Sieving expressed that the NEI looked forward to working with the new members over the next four years.



Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Scientific Review Administrators (SRA) from the CSR: Dr. Michael Chaitin, Visual Sciences C, Dr. Mary Custer, Visual Sciences A, and Dr. David Armstrong, Chief, Brain Disorders and Clinical Neurosciences Integrated Review Group.


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.

Electronic Grant Pilot

Dr. Richard S. Fisher, Director, Corneal Diseases Program, introduced an NEI initiative to provide council review materials on CD. Council members were invited to pilot the use of these materials during the meeting.


Review of Research and Training Applications

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.

Review of the Intramural Research Program

Dr. Sheldon S. Miller, Scientific Director, presented the report of the NEI Board of Scientific Counselors.


Scientific Presentation

Dr. Bruce Cumming, Laboratory of Sensorimotor Research, presented his research in a talk entitled, The Eye as a Window on the Brain.

Open Portion of the Metting

Welcome and Call to Order

Dr. Sieving welcomed guests attending the open portion of the meeting.


Dr. McNicol introduced a new member of the DER Scientific Review Branch, Ms. Karen Tolson. Karen will be serving as a Committee Management Assistant, to help with the administration of the NEI peer review committees, the Board of Scientific Counselors, and the Council. Karen comes to the NEI from the private sector, and has previous experience at the NIH in the Division of Research Grants. We are very pleased to have recruited someone with her experience and training.

Consideration of Minutes of Previous Meeting

The minutes of the September 12-13, 2002, NAEC meeting were considered and approved as submitted.


Future Council Meeting Dates

Dr. McNicol indicated that future Council meetings are scheduled for two days, and that members are asked to free that time on their calendars. The NEI does not always need the second day, so members will be contacted as soon as the schedule is known.

The following dates were previously agreed upon for future Council meetings:

June 5-6, 2000
September 11-12, 2003.

Council members established the following future meeting dates:

February 5-6, 2004
June 10-11, 2004
September 9-10, 2004

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


Budget Overview

Dr. Jack A. McLaughlin, Deputy Director, NEI, presented an overview of the NEI budget. The NIH FY2002 budget represented the fourth year of a five-year “doubling period”, FY 1998 - FY 2003. The NIH budget was $23.6 B, which represents a 15.0 percent increase over the FY 2001 level and a 73.5 percent cumulative increase since the doubling period began. The NEI FY2002 budget was $582.9 M. This represents a 14.4 percent increase over the FY2001 level and a 64.0 percent cumulative increase since the doubling period began.

The NIH has been operating under a series of continuing resolutions for FY2003. Dr. McLaughlin summarized the Congressional actions which have occurred to date. For NIH, the House has recommended a budget of $26.6 B (a 14.4 percent increase) and the Senate has recommended $26.4 B (a 13.3 percent increase). For the NEI, the House budget is $600.8 M (a 3.6 percent increase) and the Senate budget is $615.9 M (a 6.2 percent increase).


Extramural Budget Trends

Dr. McNicol reviewed NEI extramural research program operating policy under the continuing resolution (CR). The NEI has funded non-competitive continuations (Type 5) at the recommended level. Competitive grants (Types 1 and 2) have been funded at a level determined by staff after a case-by-case review of the requested budget. No funds have been provided for either administrative supplements or bridging funds. At the CR level, the NEI anticipates a success rate of 24 percent, compared with 39.7 percent for FY2002. Under the CR, there would be slight reductions in the Center Core Grant, training, and career development programs. Funds would be available to initiate two to three multicenter clinical trials and five or six Research Infrastructure Grants. The NEI would continue to support special initiatives in areas of high programmatic relevance.


Council Operating Procedures

Mr. J. Kevin Keating, Grants Management Specialist, NEI, presented the Council Operating Guidelines. Staff proposed one change to the Guidelines: the summary statements for all scored application will be provided to Council members in individual books placed at the Council table. Summary statements for unscored applications will be provided in a single book. Council members voted to approve the new Council Operating Procedures.


National Academy of Sciences Study of the Structure of the NIH

Dr. McNicol summarized the genesis of this study and directed Council members to background material in their table folders. In 1999, the Senate report 106-293 mandated that the NIH undertake a study to examine whether its organizational structure is optimal to meet scientific needs for all Americans. Accordingly, the NIH awarded a contract to the National Academy of Sciences (NAS) to conduct such a study. It was organized into two phases. Phase I was designed to develop a background white paper and establish a committee of fifteen experts representing various stakeholders. Phase II involved a series of five committee meetings to gather information, solicit public input, review written submissions, and then prepare a written report.

Two Council members testified before the NAS committee during a session to present the perspective of health-related organizations: Dr. Zadnik for the American Optometric Association and Dr. Zarbin for the Association of University Professors of Ophthalmology. Drs. Zadnik and Zarbin summarized their experience for other Council members. Both organizations expressed strong support for maintaining the existing complement of Institutes, with a greater focus on formal means of coordination across Institutes.


2003 Biennial National Advisory Eye Council Report Certifying Compliance with the NIH Policy on Inclusion Guidelines

Dr. McNicol presented this report, which is mandated by Congressional concerns regarding the ethical principal of justice and importance of balancing research burdens and benefits. She reviewed Public Law PL 103-43 which states that women and minorities must be included in all clinical research studies, as well as all Phase III clinical trials such that valid analysis is permitted. The Law also enjoins the NIH to support outreach programs to recruit and retain women, minorities, and their subpopulations in clinical studies. Dr. McNicol reviewed the current NEI strategies for compliance with this policy. These include highlighting the policy on the NEI website and in all Program Announcements and Requests for Applications; training DER staff in inclusion procedures; documenting inclusion in grant files; maintaining a centralized inclusion tracking system, monitoring analyses in all Phase III clinical trials; and collaborating with the NIH Office of Research on Women’s Health and National Center on Minority Health and Health Disparities to add special populations to NEI-sponsored clinical studies and clinical trials.

Dr. McNicol presented data on the inclusion of women and minorities in all NEI-funded extramural clinical research and Phase III clinical trials. Council members voted to accept the report and indicated that the inclusion was appropriate.


THE EYE SITE - A Traveling Exhibit on Low Vision for Shopping Centers

Ms. Judith Stein, Director and Information Officer, NEI Office of Communication, Health Education, and Public Liaison (OCHEPL), gave Council members an overview of the activities of her office. The office assists in the dissemination of research results, maintains the NEI website, responds to inquiries from the press and from members of the general public, collaborates with the health science communications community through the VISION Public Information Network, and administers the National Eye Health Education Program (NEHEP). Ms. Stein described NEHEP’s Low Vision initiative. Its goals are to create a community-based public education program on low vision, define low vision in simple terms, and educate the public as to what can be done and what questions to ask. The objectives are to increase public knowledge of low vision, vision rehabilitation services, adaptive devices, and the NEI’s medical research.

Ms. Jean Horgan, Senior Communications Specialist and Public Liaison Officer, OCHEPL, described the Eye Site, a traveling exhibit designed to target individuals age 65 and older, Blacks and Hispanics, family and friends, and health care and social service providers. The exhibit is displayed in shopping centers. It consists of five kiosks which provide information on low vision services and resources, using interactive multimedia touchscreen displays. Ms. Horgan demonstrated the Eye Site public service announcement and a slide show highlighting the features of the exhibit. In 2001-2001 the exhibit was displayed at 32 shopping malls in 14 states, reached 13 million visitors, and distributed 39,000 publications. In 2003 the exhibit will tour the states of Colorado, Pennsylvania, Kansas, and Nebraska, as well as the District of Columbia. The exhibit has won several awards and has been prominently featured in local television and radio coverage during its tour.


Pathophysiology of the Optic Nerve and Ganglion Cell Degeneration Workshop Report

Dr. Ellen Liberman, Glaucoma Program Director, reported on this NEI-sponsored workshop. It was held at the Airlie Conference Center, Airlie, Virginia, on November 12-13, 2002. The workshop examined current hypotheses of glaucoma pathophysiology, explored whether mechanisms of chronic neurodegeneration are relevant to the etiology of glaucoma, and discussed the key systems and models that might be explored in neuroprotection of retinal ganglion cells. The post-meeting report will be posted on the NEI website this summer.


International Symposium on Ocular Immunology, Inflammation, and Transplantation

Dr. Fisher described this symposium held in September, 2002, at the University College of London, England, to explore cutting edge topics related to ocular immunology, inflammation, and transplantation. This meeting included scientists from multiple disciplines within vision research, as well as invited participants from fields outside vision research. As part of these scientific activities, NEI convened a section to explore the evidence implicating inflammation, immunity, and infection in multifactorial eye diseases such as age-related macular degeneration, diabetic retinopathy, glaucoma, and dry eye. The participants sought to identify common pathways, factors, and processes that contribute to these diseases and to define new directions for future research support to stimulate studies in these areas.

Dr. Fisher highlighted several points agreed upon by symposium participants: They indicated that although vision researchers have made observations implicating inflammation and innate immunity in diseases such as age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy, glaucoma and dry eye, as well as observing the cells and/or molecules associated with inflammation and innate immune responses in affected ocular tissues, causal relationships have not been demonstrated, nor have experiments been designed to test for a causative role. Scientists outside vision research have brought forward similar evidence linking inflammation, immunity and infections to the pathogenesis of multifactorial diseases such as atherosclerosis, stroke, multiple sclerosis, Alzheimer’s Disease, and cancer. But again, few hypotheses have been advanced to provide a pathogenic rationale for these observations. The participants noted that these observations have been circumstantial, and that few trained immunologists have been involved in these studies. Funding mechanisms are needed to encourage collaborative relationships between experts in immunity and inflammation and vision investigators studying these diseases. Such multidisciplinary, collaborative research is essential to rapid progress in this area. A series of workshops should examine the recent data in a broad intellectual context. It is imperative to bring together vision researchers who have implicated inflammation and immunity in these diseases; experts in inflammation and immunity; and scientists from other disciplines.


Future Directions and Opportunities in Retinal Degeneration Research

Dr. Andrew Mariani, Fundamental Retinal Processes Program Director, described the Retinal Degeneration Conference, held September 30-October 5, 2002, supported under an NEI Conference Cooperative Agreement Grant award. This conference attracted international experts in the area, and provided travel support for new investigators, postdoctoral fellows, and graduate students. The agenda included two keynote lectures, seven platform sessions, 74 poster presentations, and a summary session on “Future Directions and Opportunities in Retinal Degeneration Research”. This session identified a number of topics for consideration as program planning initiatives. These included neuroprotection, analysis and characterization of drusen, mechanisms by which genetic mutations lead to cell death, retinal pigment epithelium phagocytosis, and regional differences in susceptibility to degeneration.


NIH Extramural Loan Repayment Programs

Dr. Chyren Hunter, NEI Training Officer provided an overview of the NIH extramural loan repayment programs for clinical researchers and for pediatric researchers. The purpose of these programs is to recruit and retain highly qualified health professionals as clinical researchers. Qualified candidates can apply for up to $35,000 annually toward their outstanding eligible education debt, as well as the concurrent income tax reimbursement, for up to two years. One renewal is possible.

Dr. Hunter indicated that the NEI received ten eligible applications in FY2002, and all were funded. New applications were available in November, 2002, for a January 31, 2003, deadline.



Dr. Sieving adjourned the meeting at 4:34 p.m. on January 24, 2003.

Friday, January 24, 2003

Open Portion of the Meeting

Welcome and Call to Order

Dr. Sieving re-convened the open portion of the meeting on Friday, January 24, 2003, at 8:30 a.m. in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland.

Program Planning

Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, reviewed the two step program planning process. Phase I is the preparation of a streamlined document which identifies recent research progress, overarching programmatic goals, and program objectives. The second phase involves a continuous process in which workshops, symposia, and meetings are used to highlight emerging areas of science. These activities would produce reports to complement and update the document produced in Phase I.


PHASE I: Progress Report

Mr. Davis indicated that the NEI had engaged the vision research community through a letter from Dr. Sieving requesting input for the Phase I document. The responses have been collected by staff and will be made available to members of the individual program planning panels. The panels will meet and produce a draft document which will be brought to Council at the June 5-6, 2003, meeting.


PHASE II: Directions and Opportunities

Council members indicated the need to prioritize topics that need a conceptual emphasis. Specific suggestions included the cell biology of visual neurons, the cell biology of wound healing, and brain plasticity. Members also indicated the importance of including scientists outside vision research when exploring emerging areas of science. Members also emphasized the importance of systems-level interactions in the visual system as well as the need to consider cross-cutting issues. The latter might include clinical research, transcriptional control mechanisms, gene therapy, proteomics, stem cells, genomics, regeneration and repair, the genetics of complex diseases, and translational research.



Dr. Sieving adjourned the meeting at 12:00 p.m. on January 24, 2003.


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 June 5-6, 2003 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)

Ruben Adler, Ph.D. (05)
Department of Ophthalmology
600 N Wolfe St Maumenee 519
Johns Hopkins University School Med.
Baltimore, MD 21287-9257

Roy Beck, M.D., Ph.D. (05)
Jaeb Center for Health Research
Suite 9, 3010 East 138th Avenue
Tampa, FL 33613

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
100 Stein Plaza, BH623
Los Angeles, CA 90095-7000

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

Gordon E. Legge, Ph.D. (03)
Department of Psychology
University of Minnesota Twin Cities
75 E River Rd N218 Elliott Hall
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
1575 N Barrington Rd, Suite 105
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (04)
Senior Partner
Salem, Saxon, P.A.
101 E Kennedy Blvd, suite 3200
Tampa, FL 33602

Lois E. Smith, M.D. (05)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston, MA 02115

P. Sarita Soni, O.D. (03)
School of Optometry
Indiana University
800 E Atwater
Bloomington, IN 47405

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

Janey Wiggs, M.D., Ph.D. (05)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
243 Charles St
Boston, MA 02114

Karla Zadnik, O.D., Ph.D. (04)
College of Optometry
Ohio State University
338 West 10th Ave
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

Elias A. Zerhouni, M.D.
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