NAEC Meeting Minutes - September 11-12, 1997

Department of Health and Human Services
National Institutes of Health

National Eye Institute

September 11-12, 1997

The National Advisory Eye Council (NAEC) convened for its eighty-seventh
meeting at 8:30 a.m. on Thursday, September 11, 1997, 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 11:00 a.m., followed by the closed session for the
review of grant applications until adjournment at 2:30 p.m. The meeting
resumed in open session at 8:30 a.m. on Friday, September 12, for a
discussion of program planning activities, and adjourned at 1:00 p.m.
Attachment A provides a roster of Council members.

Council members present:

Dr. Anthony J. Adams

Dr. David C. Beebe

Ms. Sue Dauphin

Dr. Marian R. Fisher

Mr. Richard T. Hellner

Dr. Eve J. Higginbotham

Dr. David H. Hubel

 

Dr. Millicent L. Knight

Dr. Carl Kupfer (Ex Officio)

Capt. David O. Mazur (Ex Officio)

Dr. Ken Nakayama

Dr. Anthony B. Nesburn

Dr. David S. Zee

Council members absent: Dr. Diane L. Hatchell (Ex Officio)

Special Council Consultant: Dr. Richard H. Masland

NEI Staff Present:

Ms. Margie Baritz

Ms. Felicia Brice

Mr. Michael Coogan

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

Dr. Ralph J. Helmsen

Ms. Rosemary Janiszewski

 

Dr. Natalie Kurinij

Dr. Ellen Liberman

Dr. Andrew P. Mariani

Dr. Jack A. McLaughlin

Dr. Loré Anne McNicol

Dr. Carmen P. Moten

Ms. Kathleen Moy

Dr. Michael D. Oberdorfer

Ms. Jane Schriver

Ms. Karen Robinson Smith

Dr. Robert D. Sperduto

Ms. Judy Stein

Mr. John Whitaker

Ms. Cheryl Wild

Other NIH Staff Present:

Dr. Luigi Giacometti, DRG

Dr. Carole Jelsema, DRG

Mr. John Uzzell, OD

Food and Drug Administration Staff Present:

Dr. A. Ralph Rosenthal

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

Mr. Rupert Ambrose, R.O.W. Sciences, Inc.

Mr. Chad McEachern, American Optometric Foundation

Dr. Paul O’Brien, Health Research Associates

Dr. John Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Kupfer called the meeting to order and welcomed the Council members
and guests. He introduced and thanked Dr. Richard H. Masland who agreed to
participate in the meeting as a Special Council Consultant. Dr. Kupfer
thanked the two retiring members, Ms. Dauphin and Dr. Nakayama, for their
outstanding service on the NAEC.

II. Death Of Roy H. Steinberg

Dr. Kupfer spoke about the loss of Dr. Roy H. Steinberg, a member of the
Council. Dr. Steinberg died on July 26, 1997. A memorial service for Dr.
Steinberg had been held in San Francisco on September 7. Dr. Peter A.
Dudley had represented the NEI at the service. Dr. Jane M. Gitschier, Dr.
Steinberg’s wife, asked that in lieu of flowers or gifts, memorial
donations be directed to either the Roy H. Steinberg Memorial Outpatient
Care Fund, the Roy H. Steinberg Fund for Research on the Causes and
Treatment of Multiple Myeloma, Arkansas Cancer Research Center, or the
Foundation Fighting Blindness. Dr. Kupfer announced that Vision
Research—A National Plan: 1999-2003
would be dedicated to Dr.
Steinberg. The text of that dedication follows.

Roy H. Steinberg, M.D., Ph.D.

1935-1997

Not long after the creation of the National Eye Institute (NEI)
by Congress in 1968, a young, promising vision research scientist
named Roy Steinberg received one of the first NEI Research Career
Development Awards. This marked the beginning of a long and productive
association between the NEI and a researcher who served the vision
community in many ways.

With his great breadth of knowledge and sharp mind, Roy had a
clearer grasp than most of the many facets of retinal research, both
clinical and basic. Most productive scientists establish a single
theme to their research program during their career. Roy was
different, adapting to new ideas and seeking challenging new avenues
through which to pursue his numerous research interests. His early
work led to a greater understanding of the complex active and passive
ionic mechanisms governing retinal pigmented epithelium (RPE) cell
transport properties. He showed how the RPE contributes to the
electroretinogram and controls the environment surrounding the
photoreceptor cells.

In the late 1980s, while maintaining an interest in retinal
physiology, he and his colleagues at the University of California at
San Francisco became interested in growth factors and their potential
use in slowing or preventing retinal degenerations. Roy was
instrumental in demonstrating that basic fibroblastic growth factors
could act as a survival-promoting neurotrophic factor in hereditary
retinal degenerations. At the time of his death, he was involved in
experiments he believed could lead to treatment of blinding diseases
like retinitis pigmentosa and macular degeneration.

Roy’s great intellect, careful experimental approach, and
keen scientific insights earned him the MERIT Award from the NEI and
the Friedenwald Award from the Association for Research in Vision and
Ophthalmology. While maintaining an active and vigorous vision
research program, Roy also found time to serve as an advisor to the
NIH and NEI. He was a member and later Chair of the Visual Disorders
Study Section, the forerunner of today’s Visual Sciences C. He
served as Chair of the Retinal and Choroidal Diseases Panel for NEI’s
Vision Research — A National Plan: 1987 Evaluation and Update
and as a consultant to the 1978-1982 and the 1994-1998 National Plans.
He authored the highlights and recommendations from two NEI-sponsored
workshops — the first on the Cell Biology of Retinal Detachment
in 1986, and the second on Repair and Replacement to Restore Sight in
1991. In 1994 he was appointed to the National Advisory Eye Council,
where he served with great distinction until his death.

The NEI and the vision community have lost a dear friend. We are
deeply indebted to Roy for his unselfish service and loyalty. The NEI
is proud to dedicate Vision Research — A National Plan:
1999-2003 in his honor.

Carl Kupfer, M.D.

Director

National Eye Institute

III. Confidentiality / Avoidance of Conflict of Interest

Dr. Jack A. McLaughlin, Director, Division of Extramural Research, NEI,
and Executive Secretary of the Council, reviewed policies and procedures
regarding confidentiality and avoidance of conflict of interest situations.

IV. Consideration of Minutes of Previous Meeting

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

V. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

January 29-30, 1998

June 11-12, 1998

September 17-18, 1998

VI. Government Performance and Results Act

Mr. John Uzzell, Director, Division of Strategic Evaluation, Office of
Strategic Planning and Evaluation, NIH, presented an overview of NIH’s
implementation of the requirements of the Government Performance and
Results Act (GPRA). The GPRA requires federal agencies to set strategic
goals, measure performance, and report on the degree to which goals were
met. It requires each agency to develop, no later than the end of fiscal
year 1997, strategic plans that cover a period of at least 5 years and
include the agency’s mission statement; identify the agency’s long-term
strategic goals, and describe how the agency intends to achieve those
goals through its activities and through its human, capital, information,
and other resources. GPRA also requires each agency to submit to the
Office of Management and Budget, beginning for fiscal year 1999, an annual
performance plan. The annual performance plan is to provide the direct
linkage between the strategic goals outlined in the agency’s strategic
plan and what managers and employees do day-to-day. In addition, beginning
in FY 2000, GPRA requires that each agency submit to the President and to
the appropriate authorization and appropriations committees of Congress an
annual report on program performance for the previous fiscal year. Mr.
Uzzell could only speak in general terms regarding NIH’s contribution to
the overall DHHS effort, as various documents were still undergoing
internal review. Council members suggested some examples, for instance the
economic impact of NIH-supported clinical trials and patents deriving from
intramural / extramural research, where quantitative data could be used to
measure the effectiveness of NIH programs.

VII. Fiscal Year 1998 Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the
Fiscal Year 1998 budget situation. She said that the House Appropriations
Committee had marked up the Labor HHS Education Bill on July 22, 1997. The
House bill would provide NIH with a 6% increase over FY 1997, and a 6.4%
increase for NEI. The House Report contains some general comments on
age-related macular degeneration (AMD), but also encourages NEI to conduct
a clinical trial to determine whether the antioxidant lutein confers a
protective effect against the onset of AMD.

Ms. Fivozinsky said that the Senate Appropriations Committee marked up
its bill on July 24, 1997. The Senate bill would provide both NIH and NEI
with a 7.5% increase over the FY 1997 level. The Senate Report, like the
House report, contains general language regarding AMD, and encourages NEI
to broaden the assessment of nutrients under investigation in the
Age-Related Eye Diseases Study. The Senate Report also acknowledges the
NEI’s sixth strategic program plan, and states that the Committee would
like to receive a summary of the plan during the FY 1999 appropriation
hearings. The NEI was also urged to develop research programs that will
evaluate the eye care delivery challenges associated with an aging
population and the associated higher incidence of age-related eye diseases.

VIII. Extramural Research Program

Dr. McLaughlin’s presentation covered the latest extramural budget
estimates derived from an analysis of the House and Senate appropriations
bills. House and Senate Conferees had not met at the time of his
presentation, so he used a “split the difference” approach in
making funding estimates. Dr. McLaughlin said that an appropriation of
that magnitude would provide a 7.0% increase over the comparable FY 1997
level. Dr. McLaughlin pointed out that the overall distribution of funds
among the various extramural categories of support would likely be similar
to previous years, continuing a long tradition of emphasizing research
project grants for individual investigators.

At the “split the difference” level of support, approximately
$298.9 million, NEI would be able to fund more total research project
grants in FY 1998 than it did in FY 1997. He said that at that level, a
cost of living increase could be provided for the cohort of competing
grants, and that future year commitments on noncompeting grants could be
met. Dr. McLaughlin indicated that the NEI success rate at this level
would be very similar to the FY 1997 figure of approximately 39%.

IX. Planning for a Low Vision Education Program

Ms. Rosemary Janiszewski, Deputy Director, Office of Health Education
and Communication, NEI, described plans for a new public education program
about low vision and low vision resources. Through its National Eye Health
Education Program (NEHEP), NEI is developing an education program that
will address the needs of Americans with low vision. Low vision is defined
as a visual impairment, not correctable by standard glasses or contact
lenses, that interferes with an individual’s ability to perform activities
of daily living. The objectives of the program are to:

  • Increase awareness of low vision,
  • Increase awareness of vision rehabilitation and its impact on
    quality of life, and
  • Increase awareness of low vision services and devices.

The primary audience for this program includes older adults with a
visual impairment that interferes with their activities of daily living.
The secondary audiences for this program are: primary care physicians and
other non-eye health professionals, eye care professionals, family and
friends of people with visual impairments, and social service, aging, and
support networks.

Strategies for this public education program include:

Consumers:

  • Targeted community outreach to improve access to services through
    the NEHEP Partnership and other organizations, and
  • Media programs designed to educate the audience about the issue and
    rehabilitation devices and services.

Professionals:

  • Education programs for health care providers, social service
    agencies, aging-related networks, and others.

Ms. Janiszewski finished her remarks by pointing out some challenges
that would have to be addressed to make this program effective. These
included the issue of cost reimbursement for vision rehabilitation, and
the availability and distribution of trained personnel for vision
rehabilitation services. A spirited discussion followed with Council
members asking questions and presenting views on the proposed program.
There was very strong support for the program overall. Members commented
on the importance of engaging church groups in the campaign, including
children and adolescents as targets in later phases of the program,
getting materials into the hands of practitioners, and providing better
training for professional and support staff.

X. NHANES IV Vision Component

Robert D. Sperduto, M.D., Chief, Epidemiology Branch, Division of
Biometry and Epidemiology, NEI, presented background information and NEI
plans regarding the fourth National Health and Nutrition Examination
Survey (NHANES IV). NHANES IV, administered by the National Center for
Health Statistics (NCHS), will be in operation from 1997 to 2004, and will
conduct periodic, population-based surveys to assess the health of the
U.S. population. NCHS is currently planning a cohort of about 39,000
persons, aged 2 months to 80+ years. Individuals will be invited to
participate in a home interview and an examination in a mobile van. NEI
was invited to propose a module for inclusion in the survey.

NEI’s original proposal called for interviews and eye examinations that
would have provided cause-specific data on visual impairment in the
general population. However, time and space limitations forced NEI to
scale back the proposal. The vision module now includes the following:

For persons 12+ years.

  • Measurement of distance acuity with usual correction,
  • Measurement of current correction,
  • Measurement of refractive error, and
  • Measurement of best corrected visual acuity

In addition, for persons 50+ years.

  • Near vision testing with usual correction, and
  • Administration of a visual functioning questionnaire derived from
    the NEI-VFQ

Data from the study will provide the following population-based
information by age, race and gender:

  • Distribution of visual acuity and impairment in the population with
    usual correction,
  • Distribution of visual acuity and impairment in the population with
    best correction,
  • Distribution of refractive error in the population - especially
    important because of data suggesting a marked increase in the prevalence
    of myopia for more recent birth cohorts, and
  • Relationship between visual acuity with current correction and
    visual functioning questionnaire.

Dr. Sperduto said that NCHS and NEI plan to share costs for the vision
module, with NCHS paying 51% of the total. NEI’s cost is estimated at
$1,400,000 spread over eight years. The Council expressed enthusiasm
regarding the proposed study. Several questions were asked regarding
technical aspects of the vision examinations. Dr. Sperduto explained that
the short time that could be allotted to the visual component precludes
dilated eye and slit lamp examinations.

XI. Workshop on the Medical Utility of Marijuana

Dr. Ellen S. Liberman, Vision Research Program, Division of Extramural
Research, presented an overview of a NIH workshop held on February 19-20,
on the medical utility of marijuana. The purpose of the workshop was to
exam the scientific evidence concerning the therapeutic use of smoked
marijuana and to assess the need and opportunity for further research. A
panel of scientists examined the scientific literature on marijuana as it
pertains to a range of conditions. The literature was summarized and
presented by a separate group of experts. Glaucoma was one of the diseases
covered. Dr. Paul F. Palmberg, Bascom-Palmer Eye Institute, University of
Miami School of Medicine, was the glaucoma expert on the panel. Dr. Paul
L. Kaufman, University of Wisconsin, summarized the literature on
marijuana as it pertained to glaucoma. Time was allotted for public
comment. With respect to glaucoma, the panel cited evidence that marijuana
can lower intraocular pressure. The panel expressed concern regarding the
reported blood pressure lowering effect of smoked marijuana, in that blood
flow to the optic nerve could be compromised. The mechanism of the
intraocular pressure lowering effect of marijuana is not known, but is
evaluable. It would be helpful to know whether the mechanism of action is
unique to marijuana or identical to the mechanism of action of available,
better-tested medications. The panel concluded that a unique mechanism of
action might provide additive benefit, whereas a mechanism identical to an
available medication would suggest an unfavorable benefit / risk ratio.

XII. Diabetes Initiative

Dr. Peter A. Dudley, Vision Research Program, Division of Extramural
Research, briefly reviewed recent NIH activities related to diabetes
research. On August 4, President Clinton held a news conference at
Georgetown University Medical Center to announce the signing of the
balanced budget legislation. At the press conference the President
announced that the new legislation, among other things, would enable DHHS
to increase funding for Type I diabetes research by $150 million over the
next five years. The President went on to explain that a workshop would be
held soon at NIH to bring together scientists to discuss promising areas
of diabetes research. Other highlights from the President’s comments
included his announcement that there would be a $150 million grant to the
Indian Health Service for diabetes prevention efforts and research and
treatment in Native American communities.

A meeting was held September 4-5 on the NIH campus to discuss the
challenges and opportunities in diabetes research. The workshop was
sponsored by Dr. Varmus and NIDDK and co-sponsored by eight other NIH
institutes with an interest in diabetes, including NEI. The meeting format
consisted of several panels representing specific areas of diabetes
research. One panel focused on the microvascular complications of
diabetes, and several NEI-funded scientists were invited to participate
and make recommendations. A final report of the recommendations of the
participants will be presented to Dr. Varmus shortly. Dr. Dudley said that
the report will be available to the public when it is completed.

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 Intramural Research Program

The Council considered 280 research and training applications requesting
$268.6 million in total costs. The Council recommended 247 applications
with a total cost of $168.6 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.

XIV. Adjournment

Dr. Kupfer adjourned the meeting at 2:30 p.m. on September 11,1997.

Open Portion of the MeetinG - Part II

XV. Resumption of Meeting

Dr. Kupfer called the meeting to order in open session at 8:30 a.m. on
Friday, September 12, for a discussion of program planning activities.

XVI. Vision Research—A National Plan: 1999-2003

Dr. Kupfer began the meeting by stressing that the first priority for
funding research will always be scientific merit as assessed by peer
review. In making funding decisions, however, issues of program relevance,
program balance, and the availability of funds must also be taken into
consideration by the NEI. Dr. Beebe made a few remarks and reminded
everyone that not every area of research supported by NEI would be
highlighted in the new Plan. Dr. Hubel encouraged the authors, and
particularly the authors of the executive summary, to avoid use of
language which is overly-technical. The new Plan will assess progress
since the last Plan and highlight specific areas where both scientific
need and special opportunity exist for future progress. Mr. Michael Davis,
Director, Office of Science Policy and Legislation, NEI, gave an overview
of the planning process, including how the new Plan would contribute to
NEI’s implementation of the Government Performance and Results Act. A
presentation on the status of each of the seven panel reports was led by
the NEI extramural program directors as follows: Corneal Diseases (Dr.
McNicol); Lens and Cataract (Dr. Liberman); Glaucoma (Dr. Liberman);
Retinal Diseases (Drs. Dudley and Giovanni); Strabismus, Amblyopia, and
Visual Processing (Dr. Oberdorfer); Vision Impairment and Its
Rehabilitation (Dr. Oberdorfer); and, Health Services Research (Dr.
Cotch). Training (Dr. Giovanni), as a “cross-cutting” issue, was
also presented. During the presentations, the Council members pointed out
a number of specific areas where the plan could be strengthened. Several
additional “cross-cutting” issues were suggested, including
research on the aging process, research on the human genome, developmental
biology and regeneration, drug delivery systems, minority health, systemic
diseases affecting vision, and trauma. Mr. Davis concluded the session by
reviewing the next steps to be taken and the timetable for their
achievement. Much would depend on the speed with which the new Plan could
be revised by the Panels to address the Council’s comments. The end of
November was set as a target date for sending revised drafts to those
organizations which have an interest in vision research. Comments received
from these organizations will be taken into consideration in preparing the
final version of the document.

XVII. Adjournment

Dr. Kupfer adjourned the meeting at 1:00 p.m. on September 12, 1997.

XVIII. 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.

Chair

National Advisory Eye Council

Director

National Eye Institute

These minutes will be submitted for the approval of the Council at the
January, 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

e-mail: lmd@eps.nei.nih.gov


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

Ms. Sue Dauphin (97)

President

National Sjogren’s Syndrome Association

Phoenix, AZ

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

Ken Nakayama, Ph.D. (97)

Professor of Psychology

Harvard University

Cambridge, MA 02l38

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

Director

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.

Secretary

Department of Health and Human Services

Washington, D.C.

Harold Varmus, M.D.

Director

National Institutes of Health

Bethesda, MD

Carl Kupfer, M.D. (Chair)

Director

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

Captain David O. Mazur, MC, USN

National Naval Medical Center

Bethesda, MD

Executive Secretary

Jack A. McLaughlin, Ph.D.

Director, Division of Extramural Research

National Eye Institute

National Institutes of Health

Bethesda, MD