NAEC Meeting Minutes - January 29, 1998

Department of Health and Human Services
National Institutes of Health

National Eye Institute

January 29, 1998

The National Advisory Eye Council (NAEC) convened for its eighty-eighth
meeting at 8:30 a.m. on Thursday, January 29, 1998, in Conference Room G,
Executive Plaza North, National Institutes of Health (NIH), Rockville,
Maryland. The Director of the National Eye Institute (NEI), Carl Kupfer,
M.D., presided as Chair of the Council. The meeting was open to the public
from 8:30 a.m. until 12:15 p.m., followed by the closed session for the
review of the intramural research program and grant applications until
adjournment at 4:15 p.m. Attachment A provides a
roster of Council members.

Council members present:

Dr. Anthony J. Adams

Dr. David C. Beebe

Dr. Marian R. Fisher

Lt. Col. William J. Flynn (Ex Officio)

Dr. Diane L. Hatchell (Ex Officio)

Mr. Richard T. Hellner


Dr. Eve J. Higginbotham

Dr. David H. Hubel

Dr. Millicent L. Knight

Dr. Carl Kupfer (Ex Officio)

Dr. Anthony B. Nesburn

Dr. David S. Zee

Council members absent: none

Special Council Consultant: Dr. Dean Bok, Capt. David O. Mazur

NEI Staff Present:

Ms. Margie Baritz

Ms. Olive Childers

Dr. Mary Frances Cotch

Mr. Michael Davis

Ms. Linda Dingle

Dr. Peter A. Dudley

Ms. Judy Duff

Ms. Lois Eggers

Mr. Donald F. Everett

Ms. Carol Fivozinsky

Dr. Maria Y. Giovanni

Ms. Carolyn E. Grimes

Ms. Jean Horrigan

Ms. Linda Huss

Dr. Ralph J. Helmsen


Dr. Natalie Kurinij

Ms. Kym L. Collins-Lee

Dr. Ellen Liberman

Dr. Andrew P. Mariani

Dr. Jack A. McLaughlin

Dr. Loré Anne McNicol

Dr. Carmen P. Moten

Ms. Kathleen Moy

Dr. Robert Nussenblatt

Dr. Michael D. Oberdorfer

Dr. Joram Piatigorsky

Ms. Jane Schriver

Ms. Karen Robinson Smith

Ms. Judy Stein

Mr. John Whitaker

Mr. Terry Williams

Ms. Moniek Wood

Other NIH Staff Present:

Dr. John Bowers, CSR

Dr. Luigi Giacometti, CSR

Dr. Len Jakubczak, CSR

Dr. Carole Jelsema, CSR

Dr. L. R. Stanford, CSR

Food and Drug Administration Staff Present:

Dr. Donna Lochner

The following members of the general public were present at the open session:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology

Dr. Israel Goldberg, Health Research Associates

Ms. Carrie Kovar, American Academy of Ophthalmology

Ms. Wendy Landon, R.O.W. Sciences, Inc.

Ms. Nancy Mulligan, NMG

Dr. Paul O’Brien, Health Research Associates

Ms. Victoria Singer, American Optometric Foundation

Mr. Rick Stout, Prospect Associates

Dr. John C. Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Jack A. McLaughlin, Director, Division of Extramural Research (DER),
and Executive Secretary of the Council, called the meeting to order and
welcomed the Council members and guests. He introduced Lieutenant Colonel
William J. Flynn, USAF, MC, who had been named by the Department of
Defense to serve as its ex officio member of the Council. Dr. Flynn is the
Director of Residency Training and Research, Department of Ophthalmology,
Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, Texas.
He is also the Associate Chief of the Glaucoma Service and Chief of
Cataract Surgery.

Dr. McLaughlin next introduced Dr. Dean Bok who had agreed to
participate in the meeting as a Special Council Consultant. Dr. Bok is the
Dolly Green Professor of Ophthalmology, Jules Stein Eye Institute, and
Professor of Neurobiology, Anatomy, and Cell Biology, University of
California, Los Angeles. He is a distinguished scientist, having received,
among many honors, the MERIT award from NEI and the Friedenwald award from
the Association for Research in Vision and Ophthalmology (ARVO).

Dr. McLaughlin then thanked Dr. David Mazur for four years of
outstanding service as an ex officio member of the Council and presented
him with a certificate expressing NIH’s appreciation for his efforts. Dr.
Mazur had agreed to participate in the January meeting as a Special
Council Consultant.

Dr. McLaughlin announced that Mr. Edward H. McManus had officially
retired from his position as Deputy Director of the Institute. He said
that Mr. McManus would be active in a number of Institute activities in
his new role as the Senior Management Advisor to Dr. Kupfer. Following Mr.
McManus’ retirement, Dr. Kupfer appointed Dr. McLaughlin as Deputy
Director and Ms. Judy Duff as Acting Executive Officer of the Institute.

II. Confidentiality / Avoidance of Conflict of Interest

Dr. McLaughlin 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
were later asked to sign a statement certifying that they were absent
during such discussions.

III. Consideration of Minutes of Previous Meeting

The minutes of the September 11-12, 1997 Council meeting were considered
next. The minutes were approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

June 11, 1998

September 17-18, 1998

February 4-5, 1999

June 10-11, 1999

September 16-17, 1999

V. Fiscal Year 1998 Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the
budget situation for Fiscal Years 1998 and 1999 (Attachment B). She said
that NEI had received a Fiscal Year (FY) 1998 budget of $355.7 million, an
increase of 7.3% over the FY 1997 budget. The percentage increase received
by NEI was in line with the increases received by most of the other
Institutes. The NIH received a percentage increase of about 7.1% overall.

Ms. Fivozinsky next reviewed some of the highlights of language
contained in the House and Senate Reports which accompanied the
appropriations bill. Both the House and Senate reports reflected an
interest in the possible protective effects that antioxidants and
nutrients might have on age-related macular degeneration. The Senate
report mentioned two other topics: (1) the NEI’s sixth long-range program
plan for vision research, and (2) the eye care delivery challenges
presented by an aging U.S. population and the associated higher incidence
of age-related eye diseases.

Ms. Fivozinsky indicated that she was not able to discuss the details of
the FY 1999 budget request until the President formally submitted it to
Congress. She said that Dr. Gerald Chader, Chief Scientific Officer of the
Foundation Fighting Blindness, had testified before the Labor, HHS
Appropriations Subcommittee. Dr. Chader spoke on behalf of ARVO and the
Alliance for Eye and Vision Research. His testimony, which was
well-received, included a request that the Subcommittee support a 15%
increase in the FY 1999 NEI budget. The NIH Director and Institute
Directors were scheduled to give their testimonies before the House
Subcommittee in mid-March. Ms. Fivozinsky indicated that considerable
enthusiasm had been expressed recently by prominent members of both the
House and Senate for a doubling of the NIH budget over the next five years.

VI. Extramural Research Program

Dr. McLaughlin’s presentation covered the latest extramural budget
estimates for the extramural research program. Dr. McLaughlin pointed out
that the overall distribution of funds among the various extramural
categories of support in FY 1998 would be similar to that of previous
years, continuing a long tradition of emphasizing research project grants
for individual investigators. He said that NEI would be able to fund more
total research project grants in FY 1998 than it did in FY 1997, that a
cost of living increase would be provided for the cohort of competing
grants, and that future year commitments on noncompeting grants would be
met. Dr. McLaughlin indicated that the NEI success rate would be very
similar to the FY 1997 figure of approximately 39%.

VII. Council Operating Procedures

Ms. Carolyn E. Grimes, Chief, Grants Management Branch, DER, NEI,
reviewed the formal guidelines for Council operations which cover
procedures for the Council review of grant and cooperative agreement
applications, and for staff negotiations and administrative actions
concerning projects recommended previously by the Council. Following a
brief discussion, Council voted unanimously not to make any changes from
the previously approved operating procedures (Attachment B).

VIII. Update: Program Planning

Mr. Michael Davis, Associate Director for Science Policy and
Legislation, NEI, provided a brief update on progress toward publication
of Vision Research–A National Plan: 1999-2003. He said the next
steps would be to do a final edit and review, prepare an executive summary
that could be available for the appropriations hearings in early March,
and send the plan to the publication contractor for copy editing, desktop
publishing, HTML formatting for the worldwide web, and final printing of
the full report and separate executive summary. Mr. Davis thanked the
Council members for their efforts throughout the planning process and for
the many suggestions he had received for improving the document. He agreed
that the Council would have an opportunity to review the final draft plan
prior to its submission to the contractor for publication.

IX. Diabetes Research Initiative

Dr. Peter A. Dudley, Division of Extramural Research, NEI, brought the
Council up to date on the NIH diabetes research initiative. He briefly
summarized the outcome of the meeting held on September 4-5, 1997, “Diabetes
Mellitus: Challenges and Opportunities.” Convened at the request of
the President, this meeting addressed important issues in the etiology and
treatment of diabetes and its complications. The participants discussed
important research challenges and opportunities for the future in five
research areas. A series of Requests for Applications were subsequently
developed by NIH staff. Of special relevance to NEI, a Request for
Applications appeared in the NIH Guide on November 21, 1997,
entitled “Microvascular Complications of Diabetes Mellitus.” Six
million dollars were set aside in FY 1998 for this one-time solicitation,
and it is expected that approximately 25 awards will be made.

The Congressionally-mandated Diabetes Research Working Group met at NIH
on January 28, 1998. Dr. Dudley attended as the NEI representative and
reported to Council on the purpose of this group. The charge to the “Congressionally-Mandated
Diabetes Research Working Group” is to develop a five-year plan for
diabetes research and to submit this plan to Congress. The Chair is Dr. C.
Ronald Kahn of the Joslin Diabetes Center in Boston. Rep. George
Nethercutt (R-WA), who has a special interest in diabetes research,
addressed the Working Group. They will review all currently funded
diabetes research at NIH and develop an overall plan to identify research
needs and opportunities. Smaller writing groups have been assembled and
will meet as needed in order to develop a plan that can be transmitted to
Congress by September, 1998.

X. Other NIH Research Initiatives

Dr. Maria Y. Giovanni, Division of Extramural Research, NEI, said that
NEI was participating in three trans-NIH initiatives which focus on the
development of new research technologies. All three of these initiatives
are in the form of a Request for Applications (RFA) to solicit research
grant applications in a particular area. Zebrafish - the NEI is
participating in an RFA to solicit applications for developing the
research tools and technologies to generate genetic and physical maps of
the zebrafish genome. Mutations that disrupt zebrafish development have
been identified in many systems, including many in the retina, and the
next step is the cloning and isolation of these mutant genes. Quantitative
Statistical Methods - this is a trans-NIH RFA to develop new
quantitative methods for mapping genes that are involved in complex human
diseases. There is a need for more powerful and sophisticated quantitative
methods for genetic analysis, particularly for complex (multigene)
diseases, such as age-related macular degeneration and glaucoma. Methods
for Discovering Single Nucleotide Polymorphisms - this RFA concerns
the development of genomic-scale technologies or projects to discover
single nucleotide polymorphisms called SNPs. Attention has been focused on
the use of SNPs as genetic markers, and they seem to have a number of
technical advantages over other markers now available. Importantly, SNPs
are well suited to create a genetic map that is of higher density than
what now exists. This will be important in mapping and identifying genes
for complex diseases.

XI. NEI’S Proactive and Reactive Information Activities

Ms. Judith Stein, Associate Director for Health Education and
Communication, NEI, described some of the principal functions of her
office. The Office of Health Education and Communication (OHEC) is
responsible for a variety of activities including the National Eye Health
Education Program; dissemination of research results; mass media
campaigns; special projects (e.g., VISION travelling exhibit and school
curriculum); publications; public inquiries; and overseeing the NEI web
site and clinical trials database. Public inquiries to the NEI have
increased from just over 6,000 in 1988 to about 18,000 in 1997. Inquirers
represent a variety of audiences from patients and their family members to
health professions to teachers and librarians. These inquirers use various
modes to contact the NEI including mail, telephone, toll-free line,
in-person visits, and, most recently, e-mail.

The NEI web site was launched in March, 1997. Internet users have added
yet another group to those seeking information, and will only increase
public access to and interest in health information. As a Federal web
site, the NEI strives to offer scientifically accurate and unbiased
information. The web site includes information all aspects of NEI
activities. Since its launch, the web site has received more than 352,000
requests from over 52,000 visitors. As a component of the NEI web site,
the OHEC has developed a full-text searchable database of 51 ongoing and
completed NEI-sponsored clinical studies. The database, which encompasses
both extramural and intramural studies, provides comprehensive information
on topics such as patient recruitment, study results, and implications for
clinical practice. The Institute had previously published this information
in periodic printed editions of the book, Clinical Trials Supported by
the National Eye Institute. However, the online database, which can be
continuously updated, allows the OHEC to provide the public with the most
current information about NEI clinical studies.

Ms. Stein gave an “on-line” demonstration of the NEI web site
including the new clinical trial database. Much discussion followed,
primarily related to a consideration of other appropriate links to other
relevant web sites (e.g., the Food and Drug Administration) that might be
incorporated into the NEI web site.

XII. NEI Scholars Award

Dr. Giovanni described the staff concept for a competitive NEI Scholars
Award, a new research career development program. The purpose of the NEI
Scholars Award is to provide an opportunity for outstanding new
investigators to receive high quality research training in the NEI
intramural program and to facilitate their successful transition to an
independent research position at an extramural institution. A formal
application and peer review procedures will be put in place. The award
will have two phases. The applicant will first identify a scientist in the
NEI intramural research program who must agree in advance to serve as a
sponsor for the first phase of the award. This first period of support
will be for three to four years and include salary and research funds
derived from NEI intramural resources. Following a successful intramural
phase, the extramural phase will begin. NEI will provide the scholar with
transitional independent research funding at an extramural institution.
This will include two years of research support funded through an
extramural grant (K22). During the extramural phase, scholars are expected
to apply for NIH support via the regular research grant program. The
Council was very enthusiatic about the concept presented for this new
award and strongly endorsed it.

XIII. 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 review takes place in the closed
session. In addition, NEI intramural scientists also make presentations
during the open session, either overviews of the activities of their
research groups, or focussed scientific presentations.

Dr. Robert B. Nussenblatt, Director, Division of Intramural Research,
presented a brief overview of the status of the intramural research
program and issues affecting it. He discussed the activities of the
Committee to Review the NEI Intramural Research Program. This Committee,
chaired by Dr. John Dowling, Harvard University, had met for the first
time on September 30, 1997. The Director’s Advisory Committee’s report on
“The Intramural Research Program,” also referred to as the “Marks
- Cassell Report,” had recommended that each NIH institute conduct
such reviews.

The charge to the Committee is broad, and includes that of reviewing and
evaluating the priorities and directions for the NEI Intramural Research
Program, the effectiveness of the organizational structure, the
effectiveness of the BSC review process, the balance between laboratory
and clinical research, and the balance between intramural and extramural research.

Dr. Joram Piatigorsky, Chief, Laboratory of Molecular and Developmental
Biology, discussed some recent research findings from his Laboratory. They
have found that the corneal epithelial cells express extremely high
concentrations of metabolic enzymes, suggesting that they have structural
as well as metabolic roles. Like the lens, the corneal “enzyme-crystallins”
may differ among species. At present the developmental expression of
aldehyde dehdrogenase class 3 and transketolase are being studied in the
corneal epithelial cells of mice. Experiments are also being conducted on
gene expression during wound healing in the cornea.

Dr. Piatigorsky said that while the crystallins of vertebrates have been
studied intensively, very little experimentation has been done on the lens
crystallins of invertebrates. They have shown that the strategy of
recruiting metabolic enzymes as refractive crystallins in the lens, which
takes place in vertebrates, also occurs in invertebrates, including squid,
scallops and jellyfish. Particular attention is being focussed on the
possibility that at least some of the mechanisms for the high expression
of crystallin genes in the lens are conserved among vertebrates and invertebrates.

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).

XIV. Review of Intramural Research Program

The Council considered the BSC review and recommendations for the
Laboratory of Molecular and Developmental Biology. Drs. Nussenblatt and
Piatigorsky were present during the discussions to provide information and
answer questions regarding implementation of the BSC recommendations.

XV. Review of Research and Training Applications

The Council considered 251 research and training applications requesting
$295.4 million in total costs. The Council recommended 243 applications
with a total cost of $221.9 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.

XVI. Adjournment

Dr. Kupfer adjourned the meeting at 4:15 p.m. on January 29, 1998.

XVII. Certification

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

Jack A. McLaughlin, Ph.D.

Executive Secretary

National Advisory Eye Council

Director, Division of Extramural Research

National Eye Institute

Carl Kupfer, M.D.


National Advisory Eye Council


National Eye Institute

These minutes will be submitted for the approval of the Council at the
June 11, 1998, meeting. Any corrections or notations will be incorporated
in 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


Attachment A

National Advisory Eye Council

Anthony J. Adams, O.D., Ph.D. (00)

Dean and

Professor of Vision Science & Optometry

School of Optometry

University of California, Berkeley

Berkeley, CA

David C. Beebe, Ph.D. (98)

Professor of Ophthalmology & Visual Sciences

Washington University School of Medicine

St. Louis, MO

Constance Cepko, Ph.D. (01)


Department of Genetics

Harvard Medical School

Boston, MA

Marian R. Fisher, Ph.D. (98)

Senior Scientist

Department of Biostatistics

University of Wisconsin

Madison, WI

Mr. Richard T. Hellner (00)

President & CEO

Prevent Blindness America

Schaumburg, IL

Eve J. Higginbotham, M.D. (98)

Professor and Chair

Department of Ophthalmology

School of Medicine

University of Maryland

Baltimore, MD

David H. Hubel, M.D. (99)

John Franklin Enders

Professor of Neurobiology

Harvard Medical School

Boston, MA

Millicent L. Knight, O.D. (99)

North Shore Eye Center

Evanston, IL

Anthony B. Nesburn, M.D. (00)


Ophthalmology Research Laboratories

Cedars-Sinai Medical Center

Los Angeles, CA

David S. Zee, M.D. (99)

Professor of Neurology, Ophthalmology,

Otolaryngology & Neuroscience

Johns Hopkins University

School of Medicine

Baltimore, MD

Ex Officio Members

Donna E. Shalala, Ph.D.


Department of Health and Human Services

Washington, D.C.

Harold Varmus, M.D.


National Institutes of Health

Bethesda, MD

Carl Kupfer, M.D. (Chair)


National Eye Institute

National Institutes of Health

Bethesda, MD

Department of Veterans Affairs Representative

Diane L. Hatchell, Ph.D.

VA Medical Center

Durham, NC

Department of Defense Representative

Lt. Col. William J. Flynn, USAF, MC

Department of Ophthalmology

Wilford Hall Medical Center

Lackland Air Force Base, TX

Executive Secretary

Jack A. McLaughlin, Ph.D.

Director, Division of Extramural Research

National Eye Institute

National Institutes of Health

Bethesda, MD