NAEC Meeting Minutes
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.
Chair
National Advisory Eye Council
Director
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
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
Constance Cepko, Ph.D. (01)
Professor
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)
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
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
