NAEC Meeting Minutes - September 14, 2000

Department of Health and Human Services
National Institutes of Health

National Eye Institute

September 14, 2000

The National Advisory Eye Council (NAEC) convened for its ninety-sixth meeting at 8:30 a.m. on Thursday, September 14, 2000, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Acting Director of the National Eye Institute (NEI), Jack A. McLaughlin, Ph.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 11:00 a.m., followed by the closed session review of the intramural research program and of grant applications until adjournment at 3:10 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Anthony J. Adams
Dr. Dean Bok
Dr. Constance Cepko
Ms. Patricia A. Cleary
Dr. Martha C. Constantine-Paton
Lt. Col. William J. Flynn (Ex Officio)
Mr. Richard T. Hellner
Dr. M. Rosario Hernandez
Dr. Gordon E. Legge
Dr. Anthony B. Nesburn
Dr. Larry J. Takemoto
Dr. Marco A. Zarbin (Ex Officio)

Council members absent:

Dr. P. Sarita Soni

NEI Staff Present:

Ms. Margie Baritz
Ms. Carol Fivozinsky
Mr. Matthew Burr
Dr. Emily Chew
Dr. Christine Colvis
Dr. Mary Frances Cotch
Mr. William W. Darby
Mr. Michael Davis
Ms. Lois M. DeNinno
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Lois Eggers
Mr. Donald F. Everett
Dr. Richard S. Fisher
Dr. Ralph J. Helmsen
Dr. Chyren Hunter
Dr. Natalie Kurinij
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Richard L. Mowery
Dr. Robert B. Nussenblatt
Dr. Michael D. Oberdorfer
Ms. Karen Robinson Smith
Ms. Judy Stein
Mr. John Whitaker

Other NIH Staff Present:

Dr. Michael Chaitin, CSR
Dr. Christine Melchoir, CSR
Dr. Carole L. Jelsema, CSR

Food and Drug Administration Staff Present:
Ms. Nancy C. Brogdon
Dr. Wiley Chambers

Members of the general public present at the open session:

Mr. Michael Crissman, Association for Research in Vision and Ophthalmology
Ms. Sarah Milo, National Alliance for Eye and Vision Research
Ms. Lois Schoenbrun, American Academy of Optometry
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Jack McLaughlin, Acting Director, NEI, and Chairman of the Council, called the meeting to order and welcomed the Council members and guests.

II. Announcements and Introductions

Dr. McLaughlin announced that Dr. Carl Kupfer has stepped down as Director of the National Eye Institute, the only person to ever serve in that position. He said Dr. Kupfer remains at the NIH and is preparing multimedia teaching materials from the files of the late Dr. David Cogan. Dr. Kupfer will also continue to see patients as part of his research activities at the NIH Clinical Center. There is an active search for a new NEI Director, and some members of Council are on the NIH search committee.
Dr. McLaughlin announced that this was the last Council meeting for three Council members, Dr. Anthony Adams, Mr. Richard Hellner, and Dr. Anthony Nesburn, and thanked them very gratefully for their service to the NEI during their tenure on the Council. Dr. McLaughlin noted that Dr. Adams would be stepping down as Dean of the School of Optometry at the University of California at Berkeley to devote more time to teaching and research. Mr. Hellner will be continuing his work with Prevent Blindness America. The NEI has appreciated his broad knowledge of vision health needs. Dr. Nesburn has been an effective advocate for corneal research during his term on Council and contributed a broad clinical perspective. Dr. Nesburn will devote renewed energies to his own research and to his leadership of the vision research group at Cedars-Sinai Medical Center in Los Angeles.

Dr. Loré Anne McNicol, Director, DER, NEI, and Executive Secretary of the Council introduced Dr. Richard L. Mowery, who has re-joined the NEI as a Program Director in the Collaborative Clinical Research group. Rick previously served as a member of the NEI Biometry and Epidemiology Program, where he assisted in the design and management of the Early Treatment Diabetic Retinopathy Study. Later, as Chief of the Collaborative Clinical Research Branch, he organized the Institute’s extramural clinical research activities. In 1995, Dr. Mowery joined the National Cancer Institute as Chief of the Clinical Trials Monitoring Branch, where he was responsible for a program monitoring the conduct of clinical trials and the quality of clinical data for all trials with anti-cancer, anti-AIDS, and chemopreventive agents sponsored by the Division of Cancer Treatment and Diagnosis.

Dr. McNicol noted that Retina Program Director Dr. Maria Y. Giovanni has left the NEI to become Assistant Director for Microbial Genomics and Technology in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases. Dr. McNicol wished her luck in this new position. The NEI is presently recruiting a replacement.

Dr. Chyren Hunter has been appointed as the new NEI Training Officer to replace
Dr. Giovanni. Chyren had been a Program Administrator in the National Institute on Deafness and Other Communication Disorders, where she administered grants on molecular and cellular biology and auditory neuroscience in the Hearing Program. Last year she joined the NEI as Director of the Oculomotor Systems Program, and later took additional responsibilities for a program in Retinal Circuitry and Neuro-Ophthalmology.

III. 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.

IV. Consideration of Minutes of Previous Meeting

The minutes of the June 8, 2000, National Advisory Eye Council meeting were considered and approved as submitted.

V. Future Council Meeting Dates

The following dates were agreed upon for future Council meetings:

February 8-9, 2001
June 14-15, 2001
September 13-14, 2001

VI. Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, summarized details of the FY2001 Administration request’s, which was formally transmitted to Congress on February 7, 2000. It included a $1 billion increase for NIH, equivalent to a 5.6% increase. Within this budget, NEI was proposed to receive a $24 million (5.3%) increase over FY 2000. In June, the House and Senate voted on appropriation bills, which recommended higher budget increases for both the NIH (14.9%) and the NEI (14.3% in the House and 14.7% in the Senate). Congress is expected to adjourn on October 6, 2000; it is possible that there will be several short-term continuing resolutions until a final budget can be agreed upon and enacted.

Ms. Sarah Milo, National Alliance for Eye and Vision Research, described the Alliance’s recent advocacy. Alliance members made 46 visits to congressional offices. During these visits Alliance members were able to present the national opportunities in vision research.

VII. Extramural Research Program

Dr. McNicol reviewed estimated budget trends for the extramural research program in FY2000. The NEI appropriation was $450 million. This was a 13.8% increase over the level for FY1999. The NEI has received approximately $7.7 million in budget transfers from other NIH components to fund multidisciplinary research in areas such as diabetic retinopathy, myopia, aging-related macular degeneration, and bioengineering. The NEI will fund approximately 1353 research grants in FY 2000, 124 more than it funded in
FY 1999. This includes two new Center Core grants and six Bioengineering Research Partnerships. The double-digit budget increase which the NEI received for FY2000 permitted an increase in the annual total cost of grants by an average of 9% ($25,012). In addition, the NEI has been able to fund a number of new scientific initiatives including: DNA microarray supplements; Drosophila, human, mouse, rat, and zebra fish genomic resources; clinical research training grants; bioethics training grants; and the enrollment of special populations in several on-going clinical trials.

VIII. Visual Functioning Assessment in Clinical and Observational Research

Dr. McNicol described the workshop on “Visual Functioning Assessment in Clinical and Observational Research” which the NEI is sponsoring on November 13-14, 2000, in Bethesda MD. The organizers are Dr. Frederick Ferris, Director, Division of Biometry and Epidemiology, NEI, and Dr. Leon B. Ellwein, Associate Director for Applications of Vision Research, NEI. Dr. McNicol indicated that the purpose of the workshop is to review experience gained with the NEI Visual Function Questionnaire (NEI-VFQ) and address issues regarding its interpretation, reliability, and validity. The agenda includes discussions of experience gained from clinical trials and observational studies, as well as an introduction to the new Refractive Error Correction Questionnaire (RECQ). The NEI has developed this tool with supplementary support from the American Academy of Ophthalmology, the RAND Corporation, the Emmes Corporation, and Dr. Peter McDonnell (University of California, Irvine). The RECQ is designed to enable reliable measurement of the effects of refractive error and its correction on vision-related quality of life and functioning. The RECQ is anticipated to become the standard for patient-reported visual functioning assessments in clinical trials and in the evaluation of new refractive error correction technologies. Dr. McNicol directed Council members’ attention to the workshop syllabus and registration forms in their table folder.

VIX. Fundamental Issues in Vision Research

Dr. Ellen S. Liberman, Lens and Cataract and Glaucoma Program Director described the fifth biennial presentation of this course at the Marine Biological Laboratories, Woods Hole, Massachusetts, on August 13-25, 2000. Dr. Liberman indicated that the purpose of the course is to attract outstanding students who know little about vision research and introduce them to cutting edge issues in vision research. She said that this year’s class had a more clinical flavor, including students from M.D. and M.D./Ph.D. programs. Three Council members, Drs. Bok, Cepko, and Hernandez, were among those who served as course faculty. They indicated that this years’ student class, with its more varied background, was outstanding. The Council members recommended that faculty be allowed to spend more time at the course in order to have increased opportunities for informal interactions with the students. Council members requested that they be sent information regarding the evolution of the course syllabus, and urged NEI staff to advertise the course widely.

Dr. Liberman noted that NEI helps support the course through a U13 Cooperative Conference Grant award. When Council last considered this application, they indicated that one weakness was the relatively low number of women faculty. Dr. Sandra Masur, Mt. Sinai School of Medicine, was recruited as a co-Director to join Dr. David Papermaster, University of Connecticut. They have substantially increased the number of women faculty members and will continue to ensure that appropriate role models are included among the teaching staff.

X. NEI Small Grants for Pilot Research (R03)

Dr. Richard S. Fisher, Corneal Diseases Program Director, described this proposed new initiative. He indicated that its goal is to provide support for short-term studies that would generate pilot data for more extensive research. These brief R03 applications would solicit innovative research covering all programmatic areas of the NEI, would include both design-driven and hypothesis-driven research, and could include feasibility studies that lack preliminary data. The R03 grants would be for three years, with annual direct costs up to $100,000; and they will be reviewed in the NEI Scientific Review Branch.

Council members urged staff to be certain that reviewers remain focused on the special review guidelines proposed for this program and avoid treating the R03s as regular research grants with extensive preliminary data. Council voted unanimously to endorse this concept.

XI. Collaborative Research

Dr. Peter A. Dudley, Director, Retinal Diseases Program, presented the concept of a new funding mechanism. The proposed program would provide extensive funds to support large consortiums that could merge different scientific disciplines and technologies, share access to services and facilities, and provide a comprehensive approach for applied research on ocular diseases and disorders. Dr. Dudley indicated that several scientific areas such as gene therapy for retinal degenerations, the rehabilitation of low vision, gene therapy for pseudoxanthoma elasticum, and the treatment of diabetic retinopathy have generated approaches that the NEI would like to see move quickly into clinical trials or applications.

Council members voted unanimously to endorse this concept.

XII. Studies Of Diabetic Retinopathy

Dr. Emily Chew, Clinical Trials Branch, Division of Biometry and Epidemiology, presented details regarding two proposed studies of diabetic retinopathy in which the NEI would collaborate with other NIH institutes. She first described the Actions to Control Cardiovascular Risk in Diabetes, or ACCORD Trial. This is a $126.6 million contract program supported by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The ACCORD protocol is a seven year study of 10,000 patients with type 2 diabetes. Patients are randomized to tight versus conventional therapy of glycemic control and to tight versus conventional control of hypertension and elevated serum cholesterol in order to measure reduction of cardiovascular risks. The NEI will fund an ancillary eye study on progression of diabetic retinopathy in 3,600 of the randomized patients. The patients will have eye exams and fundus photography at baseline and at three years, and the costs will be approximately $520,000 per year.

The second trial that Dr. Chew described is the Family Investigation of Nephropathy and Diabetes, or FIND Study. This is a $19.5 million cooperative agreement funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute. The goal of FIND is to identify genes which predispose to diabetic nephropathy in patients with types 1 and 2 diabetes and their family members. The FIND protocol will explore both candidate gene and linkage analysis as well as mapping by admixture disequilibrium. The NEI will fund an ancillary study to determine whether there are unique genetic factors which dispose to diabetic retinopathy and whether there are genetic factors which predispose to both diabetic complications. The NEI study will enroll 4,000 patients in four years and perform eye exams and fundus photography, with centralized photo grading. The annual costs will be $425,000.

The Council was very supportive of these studies and indicated that the cost-effectiveness of these collaborative arrangements was a strong feature.

Closed Portion of the Meeting

The next portion of 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).

XIII. Review of the Intramural Research Program

As required by the Public Health Service Act, each NIH Institute annually provides its Council a written description of the research reviewed by its Board of Scientific Counselors (BSC), and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. The Council considered the BSC review and recommendations for the Laboratory of Immunology, Part 1, and the Laboratory of Ocular Therapeutics. Dr. Robert B. Nussenblatt, Scientific Director, NEI, was present during the discussions to provide information and answer questions regarding implementation of the BSC recommendations.

XIV. Review of Research and Training Applications

The Council considered 291 research and training applications requesting $369.8 million in total all year costs. The Council recommended 289 applications with a total all year cost of $347.0 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.

XV. Adjournment

Dr. McLaughlin adjourned the meeting at 3:00 p.m. on September 14, 2000.

XVI. Certification

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


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

Jack A. McLaughlin, Ph.D.
Chair
National Advisory Eye Council
Acting Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 8, 2001, 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. Lois M. DeNinno
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-9110
FAX: (301) 402-0528
e-mail: lmd@nei.nih.gov

09/28/00


Attachment A

National Advisory Eye Council

National Eye Institute

Roster

(Terms end 11/30 of the designated year)

Anthony J. Adams, O.D., Ph.D. (00)
Dean and Professor of Vision Science and Optometry
University of California, Berkeley
Berkeley, CA 94720-2020

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

Constance Cepko, Ph.D. (01)
Professor of Genetics
Harvard Medical School
Boston, MA 02115

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

Richard T. Hellner (00)
President and CEO
Prevent Blindness America
Schaumburg, IL 60173

M. Rosario Hernandez, D.D.S. (02)
Associate Professor of Ophthalmology and Visual Sciences
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

Anthony B. Nesburn, M.D. (00)
Director, Ophthalmic Research Laboratories
Cedars-Sinai Medical Center
Los Angeles, CA 90048

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

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

Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
Professor and Chairman
Department of Ophthalmology
UMDNJ-New Jersey Medical School
Newark, NJ 07103

Ex Officio Members

Donna E. Shalala, Ph.D.
Secretary
Department of Health and Human Services
Washington, DC 20201

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

Department of Defense Representative

Lt. Col. William J. Flynn, USAF, MC, M.D.
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Chair

Jack A. McLaughlin, Ph.D.
Acting Director
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary

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