NAEC Meeting Minutes
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
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
