NAEC Meeting Minutes
Department of Health and Human Services
National Institutes of Health
National Eye Institute
June 12, 1997
The National Advisory Eye Council (NAEC) convened for its eighty-sixth meeting at 8:30 a.m. on Thursday, June 12, 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 11:45 a.m., followed by the closed session until adjournment at 4:00 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 Dr. Diane L. Hatchell (Ex Officio) Mr. Richard T. Hellner Dr. Eve J. Higginbotham |
Dr. Millicent L. Knight Dr. Carl Kupfer (Ex Officio) Capt. David O. Mazur (Ex Officio) Dr. Ken Nakayama Dr. Roy H. Steinberg Dr. David S. Zee |
Council members absent:Dr. David H. Hubel
NEI Staff Present:
Ms. Margie Baritz Dr. Mary Frances Cotch Mr. Michael Davis Ms. Linda Dingle Dr. Peter A. Dudley Ms. Lois Eggers Mr. Donald F. Everett Ms. Carol Fivozinsky Dr. Maria Y. Giovanni Ms. Carolyn E. Grimes Dr. Ralph J. Helmsen Dr. Natalie Kurinij Dr. Ellen Liberman |
Dr. Andrew P. Mariani Dr. Jack A. McLaughlin Dr. Loré Anne McNicol Mr. Edward H. McManus Dr. Carmen P. Moten Ms. Kathleen Moy Dr. Robert B. Nussenblatt Dr. Michael D. Oberdorfer Ms. Karen Robinson Smith Ms. Judy Stein Mr. John Whitaker Mr. Terry Williams |
Other NIH Staff Present:
Dr. Ellie Ehrenfeld, DRG
Dr. Luigi Giacometti, DRG
Dr. Leonard Jakubczak, DRG
Dr. Carole Jelsema, DRG
Dr. Samuel Rawlings, DRG
Dr. Paul Seder, OD
Ms. R. Anne Thomas, OD
Food and Drug Administration Staff Present:
Dr. Wiley A. Chambers
Dr. James Saviola
The following members of the general public were present at the open session:
Ms. Joanne G. Angle, Association for Research in Vision and Ophthalmology
Dr. Chad McEachern, American Optometric Foundation
Mr. Steve Miller, American Academy of Ophthalmology
Ms. Michaela P. Richardson, R.O.W. Sciences
Open Portion of the Meeting
I. Call to Order and Opening Remarks
Dr. Jack A. McLaughlin, Director, Division of Extramural Research, NEI, and Executive Secretary of the Council, called the meeting to order and welcomed the Council members and guests. He introduced three new Council members, Dr. Anthony J. Adams, Mr. Richard T. Hellner, and Dr. Anthony B. Nesburn.
Anthony J. Adams, O.D., Ph.D. Dr. Adams is Dean and Professor of Optometry and Vision Science, School of Optometry, University of California, Berkeley. He is a recognized leader in advancing research-related activities within the Optometric community. Research in Dr. Adams's laboratory proceeds along three related paths. The first path addresses basic questions about the organization of the human retina in processing information about light, color, and control of light intensity. A second research path involves the study of retinal and visual pathway disease, particularly that associated with diabetes. The newest area of research in his laboratory is in biometrics and risk factors associated with the development of human refractive error. Dr. Adams has served on the Visual Sciences B Study Section. He was a member and Chair of the Committee on Vision, National Research Council, National Academy of Science. Dr. Adams has participated in several NEI program planning activities, and is currently a member of the National Eye Health Education Program Planning Committee.
Mr. Richard T. Hellner. Mr. Hellner is President and Chief Executive Officer, Prevent Blindness America, headquartered in Schaumburg, Illinois. Prevent Blindness America is the nation's leading eye health and safety organization dedicated to saving sight. Founded in 1908, Prevent Blindness America and its network of affiliates and divisions serve millions of people each year through public and professional education, community programs and research. Prior to joining Prevent Blindness America in 1987, Mr. Hellner served as executive consultant for the U.S. Agency for International Development, fostering private sector development in Jamaica. He has a very strong background in finance, administration, and marketing. Mr. Hellner has held a number of senior positions in the manufacturing and insurance industries and in the health care delivery sector.
Anthony B. Nesburn, M.D. Dr. Nesburn is Director, Ophthalmology Research Laboratories, Cedars-Sinai Medical Center, and Clinical Professor of Ophthalmology, Jules Stein Eye Institute, University of California, Los Angeles. He has been actively engaged in laboratory and clinical research activities involving ocular herpes simplex infection, latency, and therapy, with NEI support for many years. Dr. Nesburn received his M.D. from Harvard Medical School and was a resident and research fellow at that institution. He held academic appointments at the Howe Laboratory of Ophthalmology, Massachusetts Eye and Ear Infirmary, and at the University of Southern California, before assuming his current position in 1985. Dr. Nesburn has a long track record of service to the research community. He served on the NEI Vision Research Review Committee, and was active in several previous NEI program planning efforts. Dr. Nesburn served as Chair of the Corneal Diseases Panel for Vision Research – A National Plan: 1983-1987.
II. Confidentiality / Avoidance of Conflict of Interest
Dr. McLaughlin reviewed policies and procedures regarding confidentiality and avoidance of conflict of interest situations.
III. Consideration of Minutes of Previous Meeting
The minutes of the Council meeting of January 23, 1997, were considered next. Dr. Fisher asked that the section on Clinical Trial Planning Grants be amended to indicate that this presentation was made in the context of the ongoing long-range program planning activities. This mechanism of support had been an implementation item in previous planning efforts. The minutes were approved as amended.
IV. Future Meeting Dates
The following dates were agreed upon for future Council meetings:
September 11-12, 1997
January 29-30, 1998
June 11-12, 1998
September 17-18, 1998
V. Announcements
Dr. McLaughlin introduced a new member of the NEI staff, Mr. Terry Williams, who is the Chief of the Management Information Systems Branch in the Office of Science Policy and Legislation. Mr. Williams worked previously at the Naval Postgraduate School in Monterey, California, where he was the manager of the Systems Technology Laboratories. Mr. Williams and his Branch are responsible for all computer, local area network, and database support for NEI's Executive Plaza South and Building 31 activities.
Dr. McLaughlin next alerted the Council members to the recent retirement of the head of the NEI grants operation unit, Ms. Lilyan Atkinson. Ms. Atkinson began her 29 years of government service with the National Institute of Environmental Health Sciences. Instead of moving with that Institute to North Carolina, in 1968 she joined the newly-created National Eye Institute as one of its charter members. Her official duties included maintaining all the grant files and records, preparing all the materials for use at Council meetings, and preparing notices of grant awards. Dr. McLaughlin said that Ms. Atkinson was the NEI extramural staff's institutional memory, the local authority on grant processing, the liaison with all the other offices around the NIH that produce the grant paper trail, the timekeeper who always got everyone paid, the lost and found department, and above all else, a friend who would be missed.
VI. Communicating with the Public
Ms. R. Anne Thomas, Associate Director for Communications, NIH, began her presentation with the question, "Should NIH be a household word?" She made the point that other federal agencies such as NASA and the FDA have greater name recognition than does NIH.
Ms. Thomas reviewed some of the key findings from reports prepared by the National Cancer Institute (NCI), "The Public's Perception of Medical and Cancer Research." She said that things learned there could be applied to NIH efforts generally. NCI had conducted a series of focus groups to gain insight into key audiences' perceptions and understanding of cancer research and its accomplishments. This was followed up with a quantitative telephone survey. The terms used to describe research need to be selected carefully. For example, people were far more comfortable with the term "medical research" than with the term "biomedical research," and words like "state of the art" and "federal government" carry strong, negative connotations. Participants could identify benefits received from medical research, felt that research was important, but had little knowledge of how research was conducted or the process used to set research priorities. Telephone respondents had little familiarity with the NIH or the NCI – fewer than 5% correctly named these organizations as the entity that funds most tax-supported medical and cancer research.
Ms. Thomas said that news coverage of important scientific advances is good and getting better. The problem is that the public does not usually appreciate the link between NIH support of medical research and the advances that they hear about in the media. She proposed that this situation could be improved if all citations of NIH support consistently included the words National Institutes of Health (NIH) versus merely including citations of support from individual Institutes. There was general agreement during the ensuing discussion that this should be done. Ms. Thomas reviewed several additional strategies for improving the name recognition of NIH. These included NIH becoming an even more accessible, credible source of current health related information, providing context to new research advances; stimulating a new television series highlighting medical research; developing materials for use in smaller media markets; and, expanding and improving the content of the NIH WEB site.
Ms. Thomas finished by discussing some opportunities for Council members to improve the public's recognition of NIH and the role NIH plays in advancing medical research. Many of these ideas were addressed in the "Gilman Report" of the National Advisory Council and Board Representatives. In this regard, she complimented NEI and its supporters on the unique traveling exhibit which celebrates 25 years of NEI/NIH support for vision research.
VII. Fiscal Year 1998 Budget Overview
Mr. Edward H. McManus, Deputy Director, NEI, presented a general overview of the Fiscal Year (FY) 1998 budget situation (Attachment B). He said that FY 1997 had been a good budget year, with NEI receiving a 6.2% increase over its FY 1996 level. The President's Budget request for NEI is $340.4 million, a 2.4% increase over the FY 1997 level. Most of that increase is in research grants, with very small increases for the intramural research program, and no increases for the research management and support category. Mr. McManus briefly reviewed the schedule and proceedings of House and Senate hearings on the budget. Research on macular degeneration, in particular, was an area of significant Congressional interest. He said that the public witness hearings had been held in April. Among others,
Ms. Suzanne Gedance, Senior Vice President, Prevent Blindness America, testified before the House Appropriations Subcommittee, representing the Alliance for Eye and Vision Research. While recognizing budget constraints facing the Congress, she stressed the importance of medical research generally, and vision research in particular. The Alliance recommended a FY 1998 NEI budget level of $362.7 million, a 9% increase over the FY 1997 level and a 6.5% increase over the Administration's request. The Alliance also supported several legislative proposals which call for a doubling of the NIH budget over the next five years. Mr. McManus outlined the principal features of the FY 1998 House and Senate budget resolutions which had recently been passed, but indicated that mark up on the NIH appropriation bill would not take place until later in the summer.
VIII. Extramural Research Program
Dr. McLaughlin's presentation covered the FY 1998 President's Budget (P.B.) budget request for NEI extramural programs and the latest funding estimates for FY 1997 (Attachment C). He said that the P.B. request would allow for a 2.4% increase over the comparable FY 1997 level. This increase is less than the projected FY 1998 Biomedical Research and Development Price Index of 3.1%. Dr. McLaughlin pointed out that the overall distribution of funds among the various extramural categories of support is similar to previous years, continuing a long tradition of emphasizing research project grants for individual investigators. He indicated that the percentage of the budget devoted to Small Business Innovation Research Awards and the Small Business Technology Transfer Grants had leveled off.
At the P.B. level of support, NEI would be able to fund approximately the same number of total research project grants in FY 1998 as it will in FY 1997. However, the underlying assumptions in this estimate are that NIH would provide noncompeting grants increases of 2%, rather than the usual increases to offset the full costs of inflation, and that the cost of competing grants, on average, would increase by no more than 2%. Several Council members expressed concern with this approach to formulating the budget request, specifically that "future commitments" of noncompeting out-year grant support should be just that.
Dr. McLaughlin indicated that the NEI success rate at the P.B. level would drop only slightly from the comparable FY 1997 figure, but that to achieve this, NEI staff would probably have to make larger cuts from study section recommended levels than has been the case in recent years.
Dr. McLaughlin finished his remarks by inviting the Council members to visit the NEI internet site ( http://www.nei.nih.gov/) to explore its expanded coverage and frequent updates. Among the many recent additions to the site is an updated "Funding Information / Grants and Contracts" section which contains all special NEI application guidelines and internet links to relevant NIH sites. Also new is a "Who's Who and What's What" section which gives the roster, future meeting schedule, and minutes of prior meetings of the National Advisory Eye Council.
IX. Update: Program Planning
Dr. Higginbotham, Co-Chair of the Vision Research Program Planning Subcommittee, provided the Council with an update on the Subcommittee's activities related to the development of Vision Research—A National Plan: 1999-2003. She stated that the planning process is important, but that it seems an unnatural process to many. Dr. Higginbotham reminded the Council members that the NEI is also attempting to adhere to the guidance in the Government Performance and Results Act of 1993 in the preparation of this iteration of the plan.
Dr. Higginbotham recalled that the subcommittee had met in November 1996 to prepare the "plan for the plan" or guidance document and to discuss appointments to the panel chair/co-chair positions. She also briefly discussed the meeting after the last Council meeting (January 24, 1997) with the panel chairs/co-chairs, which was intended to focus the efforts of the panels on the detail required in the plan. Since that time, each of the program planning panels with advice and assistance from the NEI program directors have met at least once.
Dr. Beebe, the other Co-Chair of the Subcommittee, reviewed the previous day's meeting. He indicated that Mr. Hellner and Dr. Adams had joined the Subcommittee. Dr. Beebe stated that the Subcommittee had reviewed draft objectives prepared by the panels for each program, as part of the overall focus of the plan on the major goals and objectives for the future. He said the panels were also reviewing the accomplishments of the programs, as a means of conveying to Congress and others the progress that has been made since the development of the last plan. Dr. Beebe indicated that the panel draft reports are due in mid-August.
On September 12, 1997, the second day of the next Council meeting, there will be a morning session devoted to the presentation of information on the most current draft report from each panel. This will provide the Council an opportunity to review and discuss the drafts prior to the final publication of the report. Dr. Beebe said that the most current draft of each report will be sent to Council members in early September for this purpose.
X. Division of Research Grants
Dr. Kupfer next introduced Dr. Ellie Ehrenfeld, Director, Division of Research Grants, NIH. Dr. Ehrenfeld was recruited by Dr. Varmus from the University of California at Irvine and assumed the directorship in January of this year. At the University of California, Dr. Ehrenfeld was the Dean of the School of Biological Sciences and Professor of Molecular Biology and Biochemistry. Dr. Kupfer indicated that as a long-time successful NIH grantee, Dr. Ehrenfeld had participated in every level of peer review at NIH and had brought that important experience and perspective to her new position.
Dr. Ehrenfeld began her remarks by reflecting on her own career as a scientist and how the conduct of science has changed over the years. Science has become more multidisciplinary and unpredictable in its direction. As science changes, peer review needs to change too. She discussed several groups of issues confronting NIH peer review. There are a number of "process" issues: peer review takes too long; the revision procedure is too complex; the "electronic grant application," etc. These are important and highly visible issues that are being addressed. A second and more difficult set of issues involves the organization and composition of study sections, and the increasing economic pressure on clinician scientists to decline serving on study sections. A Council member said that it was his perception that study section members sometimes have a difficult time in peer review as a result of their own applications being reviewed by less than ideal study sections or by ad hoc groups. Because of the tremendous commitment which the study section members make, it was important to pay close attention to this situation. Dr. Ehrenfeld said that while there are no doubt specific examples of this type, the data indicate that study section members as a group do very well in peer review (as they should). Several Council members thought that clinician scientists serving on study sections should be given more flexibility with regard to term limits and review schedules. Dr. Ehrenfeld agreed that more could be done in this area. Another Council member commented that more training was needed on how to be reviewers, and that some thought should be given to bringing junior people in to observe the process.
Considerable discussion centered around a draft plan for the reorganization of the neuroscience review groups (including those currently in NIMH and NIDA) in the DRG. Several Council members expressed strong reservations about making changes that would affect the activities of the various Visual Sciences study sections. Several Council members who had served as study section members and who are basic scientists commented on the strong interdisciplinary scope of the Visual Sciences study sections. They felt that this breadth had elevated the field generally by ensuring that each application came under the scrutiny of experts from a variety of disciplines. The proposed reorganization would remove applications from an evaluation within the broad context of visual function. A Council member who is a clinician scientist and former member of VISB commented on the intellectual benefits to both groups of having basic scientists and clinician scientists serving on the same study section. He feared that these interactions and the resultant "technology transfer" would be lost if study sections were reorganized as proposed. The prevailing opinion among Council members about the Visual Sciences study sections was that "they are not broken, and do not need fixing." Dr. Ehrenfeld commented on several of the concerns raised, indicating that she appreciated the feedback. Regarding the issue of clinicians on study sections and the critical mass needed for effective review, she said that basic scientists and clinician scientists can relate better now than ever before. Advances in molecular genetics and the molecular basis of disease, for example, have enabled these groups to work together on the same problems. Dr. Ehrenfeld finished by saying that for many of these issues it was simply "time to make some recommendations and do some experiments." Dr. Kupfer, Dr. Ehrenfeld, and the Council members remarked on the lively discussion that had taken place and all hoped that this dialog would continue.
XI. 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, NEI, and Chief, Laboratory of Immunology (LI), reviewed some of the ongoing activities in his Laboratory. The LI conducts experimental and clinical research into the causes, prevention and treatment of ocular inflammatory processes due to autoimmune disorders, infection, or genetic defects. The LI focuses its investigations on the study of the basic mechanisms and pathology of autoimmune ocular disease and the development of clinical interventions to prevent or arrest these disorders. In addition, the LI undertakes basic and clinical studies of ocular infections, particularly those associated with AIDS-related ocular infections, and conducts randomized clinical trials of therapeutic interventions for these infections. There are currently six sections within the LI as follows: Clinical Immunology (Dr. Nussenblatt), Experimental Immunology (Dr. Gery), Gene Therapy (Dr. Csaky), Immunopathology (Dr. Chan), Immunoregulation (Dr. Caspi), Molecular Immunology (Dr. Egwuagu), and Immunology & Virology (Dr. Hooks). Dr. Nussenblatt provided a brief overview of research conducted by each Section, and then discussed two research projects in greater detail.
Gyrate atrophy is an autosomal recessive disorder resulting from an absence of the mitochondrial enzyme ornithine delta-aminotransferase. Dr. Karl Csaky is rigorously pursuing fundamental studies which explore the basis for the varying levels of transgene expression, the effect of transgene products on the metabolism of ornithine, and the effect of the altered ornithine metabolism on the target cells. He and his colleagues are exploring the use of the skin as a possible target tissue for treating this disease.
Dr. Nussenblatt reviewed some of the basic science concepts and the laboratory and clinical research which led to an evaluation of the effect and safety of the oral administration of retinal antigens as a treatment of ocular inflammation (uveitis). Reference: Nussenblatt, R.B., I. Gery, R. Ferris, J. Shiloach, N. Ramaley, C. Perry, R.R. Caspi, C.S. Foster, H. L. Weiner and S.M. Whitcup. Treatment of Uveitis by Oral Administration of Retinal Antigens: Results of a Phase I/II Randomized Masked Trial. Am J Ophthalmol. 1997;123(5):583-592. The Board of Scientific Counselors and several members of the Council described this study as an outstanding example of the important role of the NIH in the translation of the results of biomedical research to the clinical care of patients with devastating and poorly treatable diseases. The successful clinical application of research ideas in a coordinated effort with other NIH intramural programs, extramural investigators, and the private sector was said to be exemplary.
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).
XII. Review of 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 BSC, and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. During the closed session, the Council considered the BSC review and recommendations for the Laboratory of Immunology.
XIII. Review of Research and Training Applications
The Council considered 287 research and training applications requesting $283.2 million in total costs. The Council recommended 273 applications with a total cost of $171.7 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 4:00 p.m. on June 12,1997.
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.
Chair
National Advisory Eye Council
Director
National Eye Institute
These minutes will be submitted for the approval of the Council at the September, 1997, meeting. Any corrections or notations will be incorporated in the minutes of that meeting. A complete, printed copy of the Council minutes, including all 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
Carl Kupfer, M.D. (Chair)
Director
National Eye Institute
National Institutes of Health
Bethesda, MD
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
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
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
Roy H. Steinberg, M.D., Ph.D. (98)
Professor of Physiology & Ophthalmology
University of California
San Francisco, CA
David S. Zee, M.D. (99)
Professor of Neurology, Ophthalmology,
Otolaryngology & Neuroscience
Johns Hopkins University
School of Medicine
Baltimore, MD
Ex Officio Members
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
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
Executive Secretary
Jack A. McLaughlin, Ph.D.
Director, Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD
