Council Minutes - September 2005

The 96th Meeting
September 27–28, 2005

Contents

I. REVIEW OF APPLICATIONS
II. CALL TO ORDER
III. COMMENTS FROM RETIRING MEMBERS
IV. REPORT: Task Force on Minority Aging Research
V. REPORT: Working Group on Program
VI. REPORT: Biology of Aging Program Review
VII. PRESENTATION: Peer Review in a Rapidly Changing Environment
VIII. PROGRAM HIGHLIGHTS
IX. ADJOURNMENT
X. CERTIFICATION

The 96th meeting of the National Advisory Council on Aging was convened on Tuesday, September 27, 2005, at 3:00 p.m. in Building 31, Conference Room 6, National Institutes of Health (NIH), Bethesda, MD. Dr. Richard J. Hodes, Director, National Institute on Aging (NIA), presided.

In accordance with the provisions of Public Law 92–463, the meeting was closed to the public on Tuesday, September 27, from 3:00 p.m. to 5:00 p.m. for the review, discussion, and evaluation of grant applications in accordance with the provisions set forth in Sections 552(b)(c)(4) and 552(b)(c)(6), Title 5, U.S. Code and Section 10(d) of Public Law 92–463.1The meeting was open to the public on Wednesday, September 28, from 8:00 a.m. to 2:00 p.m.

Council Participants:
Dr. Marie A. Bernard
Dr. Elizabeth H. Blackburn
Dr. Melissa M. Brown
Dr. John T. Cacioppo
Dr. Linda P. Fried
Dr. Alan M. Garber
Dr. F. Michael Gloth III
Dr. Paul Greengard
Dr. Eugene Johnson
Dr. Ronald D. Lee
Dr. Virginia M.-Y. Lee
Dr. Spero M. Manson
Dr. Terry L. Mills
Dr. Gary B. Ruvkun
Dr. Albert L. Siu
Dr. Leon J. Thal
Dr. Mary E. Tinetti

Ex-officio Participants:
Dr. James F. Burris, Department of Veterans Affairs
Ms. Mary Guthrie for Mr. John Wren, Administration on Aging
Absent:
Mr. Peter W. Nauert

The Council Roster, which gives titles, affiliations, and terms of appointment, is appended to these minutes as Attachment A.

In Addition to NIA Staff, Other Federal Employees Present:
Dr. Sherry Dupere, Center for Scientific Review, NIH
Dr. Ann M. Harden, Center for Scientific Review, NIH
Dr. Donald Luckett, Center for Scientific Review, NIH
Dr. Ramesh K. Nayak, Center for Scientific Review, NIH
Dr. Antonio Scarpa, Center for Scientific Review, NIH

Members of the Public Present:
Dr. Piero Anversa, New York Medical College
Dr. Cynthia Boyd, Johns Hopkins School of Medicine
Dr. Amitabh Chandra, Harvard University
Ms. Mariana González del Riego, Rose Li and Associates, Inc.
Ms. Mary Jo Hoeksema, Population Association of America
and Association of Population Centers
Dr. Valen Johnson, University of Texas
Dr. William L. Klein, Northwestern University
Ms. Pat Kobor, American Psychological Association
Dr. Rose Maria Li, Rose Li and Associates, Inc.
Ms. Stephanie Reed, American Association for Geriatric Psychiatry

I. REVIEW OF APPLICATIONS

This portion of the meeting was closed to the public, in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552(b)(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5U.S.C. Appendix).2

A total of 1020 applications requesting $978,916,132 for all years underwent initial review. The Council recommended 538 awards for a total of $646,217,317 for all years. The actual funding of the awards recommended is determined by the availability of funds, percentile ranks, priority scores, and program relevance.

II. CALL TO ORDER

Dr. Hodes called the meeting to order at 8:20 a.m. on Wednesday, September 28, 2005, and welcomed members to the open session of the National Advisory Council on Aging.

Director’s Status Report
Dr. Hodes presented the history of NIA appropriations from 1995 through the President’s budget request for fiscal year (FY) 2006. He focused the Council’s attention on the dollar amounts corrected for biomedical inflation. NIA’s buying power has decreased steadily since 2003, reducing the amount of available resources. For example, the $1.057 billion appropriation anticipated for FY 2006 provides an increase that is far less than the estimated 3.2 percent inflation for biomedical research. This buying power may be reduced further by several events that could occur between the time monies are appropriated and the time that the NIA must obligate funds. For instance, in the past two years, a Congressional rescission has been applied to all domestic discretionary spending because of last-minute funding priorities. With the commitment to both international concerns and recent disasters on the gulf coast, it is unknown how much of the requested budget will remain intact by the time it is enacted.

To address this uncertainty, the NIA is taking an average reduction of 18 percent from the recommended levels of funding for research project grants (RPGs). The Institute has placed a cap on program project (P01) costs for the first time. Although there may be exceptions, it is expected that these exceptions will be rare. The NIA will reach a point where average cuts cannot increase without compromising the integrity of a proposed research project. At this point, the payline will diminish.
Dr. Hodes then turned to legislative changes. The NIH functions under a general Public Health Service authorization, which allows it to continue to do business even though authorizations for specific ICs expired several years ago. Appropriations have not been affected by lapses in authorization. However, the House Energy and Commerce Committee, under Chairman Joe Barton (R-TX), has drafted legislation that may affect the NIH. The legislation proposes that the House Energy and Commerce Committee may establish appropriation caps. No specifics have been proposed, so it is not known how these caps will affect appropriations. There is a concern, however, that the response to an emergency, such as the avian flu or a bioterrorism event, may be hampered by the need to ask the House Energy and Commerce Committee for new legislation for supplementary appropriations above the cap.

A second proposal that has implications for the NIH involves appropriations. At present, each IC has an appropriation line. The draft legislation proposes that appropriations be bundled to cover “enabling” or “infrastructure” ICs (such as the National Institute of General Medical Sciences, the National Human Genome Research Institute, and the National Center for Research Resources) and “categorical” ICs, including the NIA. Bundled or single appropriations that would need to be dispersed at an administrative level would have significant ramifications for the NIH.

The third proposal concerns a common fund for trans-NIH initiatives, which reflects comments by the Institute of Medicine and several other external assessments that the NIH should improve its ability to coordinate its research investment across ICs. An Office of Portfolio Analysis and Strategic Initiatives (OPASI), housed within the NIH Office of the Director, is proposed. At present, each of the 27 ICs develops its own initiatives, priorities, and plans. The OPASI would provide a coordinating mechanism similar to that for the NIH Roadmap and the Neuroscience Blueprint, in which the NIA participates. In these cases, participating Institutes would contribute a small percentage of their individual appropriations into a common fund, and a coordinated planning effort would determine how this fund is to be distributed. The OPASI would have three objectives:

• To provide strategic analysis in which improved tools and a database would balance the research investment against public health needs and burdens of illness.
• To provide evaluation for new programs and initiatives. The OPASI would perform evaluations and develop best practices for evaluation.
• To provide strategic coordination with input from the scientific, patient advocate, and lay communities, as well as from IC directors. Areas would be identified that would benefit from coordination across all of the NIH. This approach would reduce or eliminate redundancy across ICs.

Although the OPASI would depend on contributions from all ICs, managing a common fund at a time of constrained IC budgets presents a challenge. However, in the next year or two, the common fund will become synonymous with Roadmap funds. Investment in the Roadmap will escalate to approximately 1.7 percent of each IC’s budget, and unless budgetary circumstances improve, contributions to the Roadmap will not increase above this level.

Likewise, contributions to the Neuroscience Blueprint will increase by increments of 0.15 percent of each IC’s neuroscience budget until a plateau of 0.60 percent is reached in FY 2008, which would amount to about 0.3 percent of the NIA’s budget. This would result in 2 percent of the NIA budget being devoted to trans-NIH efforts. In addition, for FY 2006, about $12 million dollars have been committed to the Neuroscience Blueprint from the NIH Director’s discretionary fund.

Collaborative funding for the Neuroscience Blueprint was established in FY 2005, so ICs had little time to plan new activities for that year. Thus, FY 2005 initiatives (e.g., the Gene Expression Nervous System Atlas and the Neuroscience Microarray Consortium) largely represented an expansion of ongoing activities. Several new solicitations are anticipated for funding in FY 2006:

• Core grants, a pilot program in which cores that serve the broader neuroscience community will be established at various institutions.
• Neuromouse Project, an effort that coincides with Roadmap efforts to manipulate systematically genes of interest to the neuroscience community.
• Cross-Institute Neuroscience Training Programs, which will encourage translational research. Sub-initiatives in training will include neurobiology of disease, computational neuroscience, and neuroimaging.
• NIH Neurological Behavioral Functional Assessment Toolbox, which will generate and validate tools for measuring various aspects of behavior, including cognitive function, affective parameters, and sensory motor aspects.

Planning is under way for FY 2007. Approximately $10 million will be available for new initiatives.

Dr. Hodes addressed recent changes in conflict-of-interest rules. Amendments to the new rules maintain the principles and assure the public that research decisions made at the NIH are based on scientific evidence and are not affected by inappropriate influences. Furthermore, senior management and people who play important roles in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision-makers. To advance science and stay on the cutting edge of research, Intramural and Extramural Program staff will be allowed to interact with professional associations, participate in public health activities, and to teach. With these guiding principles, some of the recently revised rules indicate that senior employees, including IC directors, deputy directors, scientific directors, clinical directors, and Extramural Program directors, are limited in the amount of aggregate investments that they may have in a substantially affected organization (SAO).3Other employees are subject to government-wide laws to divest when specific conflicts of interest warrant it but will not be subject to a blanket prohibition. Furthermore, employment with an SAO as an outside activity is forbidden. This applies to both paid and unpaid positions. Employees are allowed to accept established awards for which there is a process for selecting the awardee and an expectation by history and intent that the award is made as an action in an ongoing series.

Council members’ questions focused primarily on the budget. With respect to bundling, a member asked whether any thought had been given to the possibility that categorical Institutes may have to compete for administrative funding. Dr. Hodes responded that this scenario had not been addressed. He added that the notion of bundling represented a compromise for legislators who had proposed to merge ICs to reduce their number. He reiterated that it was not known who would decide how to distribute money to individual Institutes.

Another Council member inquired about the driving force behind the legislation regarding authorizations. Dr. Hodes responded that most likely the driving force was a combination of the abrogation of authorizers’ responsibilities, as demonstrated by the lack of specific authorizations for several years, and the stated need to improve coordination of planning and organization at the NIH.

Several Council members raised concerns about the impacts of further budgetary cuts and how these cuts would be implemented. Program staff responded that they had tried several approaches but had not arrived at any that seemed wholly satisfactory. Dr. Hodes observed that program staff considered the proposed research and assessed the impact of the budgetary cuts on the investigator’s ability to carry out that work. NIA does not make individual reductions on any formulaic basis, such as how much funding an investigator has or in proportion to priority score percentile rank or amount requested. Program staff added that they work with individual principal investigators to negotiate reductions in scope and then document these reductions so that investigators are not penalized at review when they submit competing renewals. There also is a requirement for the scope of work to be redefined when the budgetary reduction threshold reaches 25 percent. In any case, the current process for reducing awards occurs on a case-by-case basis, usually after discussion with the Principal Investigator. Dr.Hodes reiterated that program staff made cuts in their individual programs such that the Institute average is 18 percent for all competing applications, regardless of whether they are new or renewals.

A Council member asked how much each Institute could be taxed for Roadmap funds and whether, with the creation of the OPASI, the NIH Director now could ask for funds to support the office directly rather than tap the ICs. Dr. Hodes responded that Roadmap funding has been allocated through a voluntary agreement of ICs and IC directors; the NIH Director has not exercised unilateral authority. What will happen in the future will depend on legislation regarding authorization. In response to the Council member’s other question, Dr.Hodes noted a general consensus that leaving funds in the ICs’ budget base and applying an agreed-upon formula allocation was the best approach. These contributions can be adjusted each year based on priorities.

Another Council member expressed her respect for the thoughtful way the NIA program staff handled reductions. She asked if the NIA had planned for the possibility that further budgetary cuts would require broader actions. Dr. Hodes indicated that any further cuts most likely would result in further erosion of the payline. Program staff noted that peer review is somewhat subjective and that, in some cases, applications that received outstanding priority scores appeared, to some staff members, to have low relevance. However, the Council and several program staff members expressed discomfort with an approach that would deny funding to these applications given their outstanding scores. A preferred alternative is to prospectively announce areas of high program relevance. This would require the involvement of the Council in more prospective planning. A second Council member observed that this approach would be helpful to investigators as they plan their grants. He reminded the Council of the requirement for advance review and approval for the submission of applications that request ≥ $500,000 and suggested more control at this level could be exercised.
Dr. Hodes and program staff responded that an estimated 40 percent of these requests are denied before they are ever submitted. Some ICs have established more stringent application cost thresholds (e.g., $300,000) for pre-approvals. One Council member cautioned that lowering the ceiling would generate substantial downstream consequences, including dampening population-based clinical research at a time when such research should be encouraged. Dr. Hodes added that the same could be said for animal research and other expensive but important scientific approaches.

Dr. Hodes invited NIA program staff to introduce new personnel. Dr. Nina Silverberg recently joined the Neuroscience and Neuropsychology of Aging (NNA) Program as Assistant Director of the Alzheimer’s Disease Centers Program. Dr. Laurie Ryan joined the NNA Program as a Health Scientist Administrator for the Alzheimer’s Disease Clinical Trials Program. Dr.Suzana Petanceska also joined the NNA as a Health Scientist Administrator for the Neurobiology of Aging and the Dementia Branches. Dr. Richard Suzman introduced Ms.Jeannette Russell, an executive assistant (contractor) in the Behavioral and Social Research (BSR) Program.

Future Meeting Dates
January 31–February 1, 2006 (Tuesday and Wednesday)
May 23–24, 2006 (Tuesday and Wednesday)
September 26–27, 2006 (Tuesday and Wednesday)

Consideration of Minutes of Last Meeting
The minutes of the May 2005 meeting were considered. A motion was made, seconded, and passed to approve the minutes.

III. COMMENTS FROM RETIRING MEMBERS

Each retiring Council member was presented with a certificate and a letter signed by Secretary Michael Leavitt and was invited to make comments.

Dr. Hodes first recognized Dr. Marie Bernard, who contributed in numerous capacities as a Council member, most recently by informally heading the health disparities minority research task force, in addition to sharing her expertise in geriatric research and its clinical application and translation.
Dr. Bernard commented on her enjoyable experience and expressed confidence that in spite of the budgetary challenges facing the NIA and the NIH, there is a commitment to maintaining diversity in research focus and in NIA-supported scientists.

Dr. Hodes described Dr. Michael Gloth as an active and constructive member of the Council who is committed to the career development, recruitment, and retention of clinical scientists. Dr. Gloth thanked everyone for the honor and privilege of serving on Council, particularly NIA staff for their assistance and leadership.

Dr. Hodes thanked Dr. Gene Johnson for his commitment and involvement in the Council and for his interest and thoughtfulness about a broad scope of research and Institute efforts. Dr. Johnson considered it an honor to serve on the Council under the leadership of Dr. Hodes. He thanked the NIA program staff for their help over the years and recognized the utility of their wisdom, experience, and hard work in the challenging times ahead. Dr. Hodes echoed these sentiments.

Dr. Hodes praised Dr. Ronald Lee’s leadership, particularly in chairing the review of the BSR Program, which was a model effort in terms of the thoughtful identification of issues and process, as well as his contributions during Council deliberations. Dr. Lee described his Council experience as enjoyable and stimulating, as well as an honor and a privilege. He expressed how deeply impressed he has been by the excellence and dedication of the staff, which has served to reinforce what he has known through 30 years of working with the NIH.

Finally, Dr. Hodes recognized Dr. Leon Thal for his thoughtfulness and for his unique focus and understanding of translation into clinical research, particularly in the conduct of clinical trials.
Dr. Thal also considered it a privilege to serve on the Council. He was impressed by the attention given by the staff to individual grants, which he felt was second to none.

IV. REPORT: Task Force on Minority Aging Research

Dr. Bernard reported on efforts by the Minority Task Force to generate evidence-based recommendations to be implemented during the next five years. The group has focused on health disparities, defined as differences in incidence, prevalence, mortality, and burden of diseases and other adverse health outcomes among specific populations in the United States, and has generated a document highlighting initiatives that address health disparities such as:

• Healthy Aging in Neighborhoods of Diversity Across the Lifespan, a study that involves 20 years of evaluation to assess issues related to health disparities.
• Longitudinal Studies in Health ABC.
• Health disparities in the epidemiology of Alzheimer’s disease and in normal cognitive aging.
• Disparities in the burden of illness and the efficiency of health systems.
• Disparities in menopause and in prostate cancer.
• Support for minority students and scholars to attend meetings.

The data provided to the Task Force show that the amount of effort directed to address health disparities has increased during the past five years. However, the mechanism by which estimates are made has changed. Before 2003, minority aging research was defined by the numbers of grants specifically tailored to that issue. Since 2003, research on minority aging and health disparities has been defined relative to the number of minorities in the population studied, regardless of the research aims. This change in definition accounts for some of the increase in expenditure in minority aging and health disparity research.

The number of requests for applications focused on minority health and disparities has remained constant from 2000 to 2004. The number of supplements, however, appears to have increased modestly and total funds have increased. The number of Alzheimer’s disease satellite programs, which were designed to provide outreach to areas that may not otherwise receive the education and services that accompany research, has decreased as a result of competitive review. In contrast, the Resource Centers for Minority Aging Research (RCMAR) have increased funding for minority researchers, publications from the centers have increased, and minority enrollment has increased. Dollars spent on minority health also have increased between 2000 and 2004. However, the number of minority researchers remains small, suggesting a need for continued encouragement and recruitment.

Dr. Bernard concluded by stating that the Minority Task Force will review the 40-page document carefully and provide feedback by November 1, 2005, so that formal recommendations will be ready by the January 2006 Council meeting.

A member of the Task Force added that although the number of minority participants in research is growing, that number still is not satisfactory. He suggested that the NIA consider a funding mechanism to encourage the development of community relationships vital to this type of research. At present, new investigators do not receive appropriate recognition or credit for investing their time in cultivating relationships with the community. Dr. Hodes acknowledged the RCMAR as an effort to address the need to establish relationships with communities. He further suggested that the outcomes from these efforts may inform generalized approaches to studying minority health and health disparities. The Task Force member also suggested that the NIA consider a funding mechanism to extend the research career pipeline to undergraduates and encourage them to enter doctoral programs in aging research. One model for such a program is the McNair Scholars Program, funded by the U.S. Department of Education. Dr. Hodes agreed that partnerships with agencies, such as the Department of Education and the National Academies of Science, would be useful in developing a pipeline and that the NIA and the NIH should identify their roles in these collaborations. He added that these concerns would be placed on the agenda for the next Council meeting.

V. REPORT: Working Group on Program

Dr. Linda Fried reported on the deliberations of the Working Group on Program (WGOP), which met on September 27, 2005.

A. Advisory Meetings

A small meeting will be convened in early December 2005 to plan a larger meeting to evaluate the current state of Alzheimer’s disease research, future directions, and opportunities for breakthroughs.

B. Update on the Biology of Aging Program Review

See Section VI below.

C. Support for Aging Research: Planning for Future Societal/Public Health/Health Care/Research

The WGOP discussed the importance of communicating the importance of aging research to the broader community, particularly the difference this research is making in terms of improving the health of our aging society and the potential for those concerned about the health of baby boomers. The goals of communication should focus on the import of addressing issues related to the aging of society, the demographic imperative, the human quality of life, and the economic challenges of an aging society. The broader community should be educated to understand breakthroughs in basic science, how they are supported, and how these breakthroughs will translate into improved health. For example, when drug discoveries are reported, the public should understand how much of the drug discovery effort can be attributed to NIH support of the underlying research. Research on aging should be seen as a substantial societal investment, and education efforts should emphasize a sense of urgency for this research. There have been few opportunities to communicate these messages to Congress, but all opportunities should be taken. The Friends of NIA is a group of colleagues from 30 to 40 participating organizations that can help the Institute communicate its messages. When breakthroughs are reported by the press, reports should be balanced and recognize the NIA’s role in supporting the research. NIA’s Office of Communication and Public Liaison plays an important role in that regard. Its efforts need to be complemented through outside activities.

D. Task Force on Research Work Force

Dr. Bernard reported on efforts to understand the impact of the Clinician Investigator Initiative that arose from Council activities a few years ago. Dr. Robin Barr reported on programs that have derived from these efforts, such as the Beeson Awards, a collaboration between the NIA and foundations to support clinician investigators; the NIH Loan Repayment Program, which relieves clinical investigators’ educational debt burden; and the changed structure of the Career Award Program so that awardees in their later Career Award training can accrue salary from R01 as well as Kawards. The task force must now determine whether these activities are making a difference. Dr. Barr was asked to report to the Working Group and to the Council on several issues, including the percentage of K awardees who are geriatricians and possible metrics to evaluate the return on investment. He cautioned that the recency of changes in programs and institution of new programs will make it difficult to assess their impact at this time. However, in time these activities will allow the Task Force to assess whether adequate progress is being made in the cultivation and retention of a workforce devoted to research in aging.

E. Foreign Grant Applications

Because of constrained resources, the WGOP asked for data on the proportion of the NIA budget that funds foreign awards. Seventeen grants were awarded to foreign investigators in 2004, about one percent of the grants funded by the NIA. The WGOP considered the proportion appropriate.

VI. REPORT: Biology of Aging Program Review

BAP was reviewed in four subparts: The Nathan Shock Centers, which are centers of excellence in the basic biology of aging; Office of the Associate Director activities, which include the Training Grant Program and an Animal Models Program; the Genetics and Cell Biology Branch; and the Systems Branch. Overall, the review committee felt that BAP is on an appropriate trajectory and that no major redirection is required. BAP has been highly successful in advancing research directions relevant to aging mechanisms, soliciting excellent and outstanding research grants in aging, and encouraging investigators at the edge of aging research to focus on more central aspects.

The Nathan Shock Centers of Excellence in the Basic Biology of Aging are core centers that have promoted excellent science. The review committee recommended that BAP establish a central resource that describes the resources and reagents available from the Shock Centers. In addition to informing investigators about what is available from these centers, such a resource also will promote their collaboration with other centers, such as the Alzheimer and Pepper Centers.

BAP training grants have declined with respect to the total NIA Training budget. However, training is critical to ensure the future of research in aging. The committee recommended a close scrutiny of the balance between predoctoral and postdoctoral trainee support, as well as careful attention to which institutions are better suited to predoctoral training versus postdoctoral training. In addition, committees responsible for evaluating the Training Grant Program should include expertise that transcends the field of aging. The committee hoped that reviewers from outside the aging research community would be sensitive to more innovative applications.

In discussing the Animal and Tissue Program, the review committee suggested that some animal models are likely more useful than others. The committee recommended two workshops to help BAP examine the scientific value of various animal models. The first workshop would explore which models “give the best bang for the buck.” A second workshop would consider comparative genomics among related species that can yield insight into the mechanisms of aging but may not be standard laboratory model systems. This approach has proven useful to developmental biologists.

The committee’s recommendations reflect the overall success of the science in the Biology of Aging Program and praised its excellent staff. In general, the committee recommended that BAP explore how their basic findings relate to human clinical conditions and potential interventions by increasing cross-program communications, for example, between BAP and the Geriatrics and Clinical Gerontology (GCG) Program or in interactions with the BSR Program’s prospective epidemiology and cohort studies. The committee also cautioned against a research portfolio that overemphasizes trendy ideas. For the Genetics and Cell Biology Branch, reviewers commended the focus on the genetics of aging. The Longevity of Aging Genes (LAG) initiative was singled out. It was recommended that crossover between animal studies and human aging issues should be emphasized in the immediate future. Interacting R01s or even supplements can be used to encourage investigators with R01 grants to interact with others to develop cross-cutting research activities.

With respect to the Systems Branch, a previous review had noted concerns about the immunology portfolio. During the current review, the committee noted marked improvement in this portfolio and recommended that it stay focused on the immunology of aging and the impact of immunology on aging tissues. A second recommendation was to track areas funded by other ICs at the NIH, noting gaps that may relate to aging and stimulating research to fill them. The review committee also recommended closer interactions between the Systems Branch and the GCG and NNA Programs, particularly with respect to the area of vascular dementia.

Several ideas for promising areas were addressed. However, Dr.Blackburn emphasized to the Council that this list was not in priority order. Ideas generated at the review meeting included: (1) Comparative genomics; (2) In vivo imaging; (3) The role of small RNAs, including micro-RNAs and silencer RNAs; (4) Nanotechnologies; (5) The meaning of data from mutagenesis projects; (6) Functional analyses of SNPs related to aging and wound healing; (7) Cellular and tissue homeostasis; (8) Pathways that are not only important in aging and model systems but also relevant to aging in humans; and (9) Immunology as it relates to regenerative medicine.

Research on biomarkers, or biosignatures, was discussed. Review committee members were not sure that biology of aging research is ready for such a focus.

The review committee expressed concern about the balance between R01 and P01 awards in an increasingly constrained funding environment. Finally, the committee recommended adding two Health Scientist Administrators, as requested by BAP staff.

VII. PRESENTATION: Peer Review in a Rapidly Changing Environment

Dr. Antonio Scarpa, Director of the Center for Scientific Review (CSR) at the NIH, shared his vision for peer review and CSR. He began by describing how peer review has evolved in this country and areas that must be considered by CSR to address these changes.

Peer review continues to provide value to American science. The American peer-review system has been emulated around the world. Yet, biomedical research has changed during the past 20 or 30 years. Computer technology enables faster and more efficient review. Also science and the ways research is conducted have changed. Today’s research projects involve more collaborators, larger facilities, and complex equipment. Yet, CSR and the system of peer review have not evolved to accommodate these changes.

Several issues must be addressed: (1) The need for increased communication among staff at CSR, between CSR and the ICs, and between CSR and grant applicants; (2) The need for more uniformity in the content of and time to complete summary statements; (3) The need for increased efficiency in identifying reviewers, gathering information about grant applications that are not funded, and convening study sections; (4) The need for shortened review cycles so that the pace of funding matches the speed at which research must advance. New PIs, in particular, might benefit from a shorter review cycle. (5) Inappropriate evaluation of clinical research; clinicians generally have less time for research activities, such as grant writing or grant review, so study sections are not adequately representative of clinical researchers; (6) An increasingly conservative culture that precludes the generation of new ideas; (7) The loss of experienced, senior-level reviewers and the fact that junior researchers are burdened with reviewing grants during the most challenging time in their careers; and (8) The small percentage of women and minorities on study sections, even though the number of grant applications coming from these groups has increased.

CSR has begun to address these issues by: (1) Establishing a committee to identify ways to make summary statements more uniform; (2) Using software, such as Collegix, a content analysis product, to assist in the identification of reviewers and study sections and to generate more information about grant applications that are not funded; (3) Forming an interdisciplinary group to identify ways to shorten the review cycle; (4) Making efforts to recruit more clinicians to serve on study sections; (5) Using video conferencing and teleconferencing to overcome time and geographic constraints; and (6) Promoting the use of electronic review through a secure Internet site.

A Council member inquired about training new investigators to become reviewers. Dr. Scarpa suggested that these investigators participate in study sections only once a year so that they can learn the process without being overburdened.

Council members initiated a discussion about the size and composition of study sections and about selection of reviewers. Study sections have increased in size, only a small percentage of reviewers carefully read each grant application, but all reviewers vote. Some checks and balances and training of reviewers is important. The peer review process loses credibility when investigators do not recognize any of the names on the study section roster, and increasing numbers of applications involving interdisciplinary research require reviewers who can span the broader perspective that is lost when each reviewer is expert in only one discipline. A payback system was suggested where for every ten years of funding, investigators would serve for two years as reviewers. Dr. Scarpa welcomed input from Council to help the CSR identify qualified reviewers for study sections.

A member pointed to the earlier discussion about increasing budget constraints and questioned whether study sections could consider explicitly whether proposed research is worth the cost. Study sections sometimes do factor costs into the scoring. It may not be stated in the summary that costs were not reasonable in relation to benefits, but the application would be given a poor score. Thus, investigators sometimes work to answer specific comments, even though the real problem, that the research is not worth the cost, is not communicated to the applicant investigator. Dr. Hodes observed that these decisions could be made at the peer review or programmatic levels but that study sections are asked to focus on the science. He acknowledged, however, that an assessment of the value of the science and the context of its cost were valid scientific issues, although they lie on the edge of a study section’s focus.

The discussion ended because of time constraints, but Dr. Scarpa invited the Council to contact him with further questions and suggestions.

VIII. PROGRAM HIGHLIGHTS

A. Biology of Aging: Human Cardiac Stem Cells

Dr. Piero Anversa is Professor of Medicine at the Cardiovascular Research Institute, Department of Medicine, New York Medical College. His presentation centered on recent human cardiac stem cell research findings.

Dr. Piero Anversa, Vice-Chairman of Medicine and Director of the Cardiovascular Research Institute at New York Medical College, reviewed his laboratory’s recent work on human cardiac progenitor cells and their potential for repairing tissue damaged by a heart attack.

It has been a long-held view that cardiomyocytes – muscle cells of the heart – are not renewed and that the adult heart has no internal capacity for repair. Therefore, unlike numerous other tissues such as the skin, intestines, liver, or skeletal muscle it was assumed that the heart lacked an intrinsic stem cell population whose function would be to replace cardiomyocytes that have died normally (for example, during aging) or traumatically (for example, from a heart attack). Thus cell death is the major acute response and scarring and pathological remodeling are the major long-term responses to a heart attack, but cell replacement seemed to be outside the available options for cardiac repair and renewal. However, if stem cell pools from bone marrow or another tissue could be identified that would differentiate into cardiomyocytes or if a cardiac stem cell pool does exist, either pool would be extremely useful for the clinical treatment of heart attacks. Dr. Anversa and his colleagues have identified cardiac stem cells that are resident in the adult heart and can be mobilized to repair damaged tissues resulting from an ischemia-induced heart attack. Furthermore, treatments that “add back” stem cells or enhance the mobilization of this cardiac stem cell pool can restore significant levels of cardiac function that had been lost following a heart attack; function that would not be restored in the absence of such treatments.

The original discovery of cardiac stem cells in the adult heart was made by Anversa’s group about five years ago (reviewed in Anversa and Nadal-Ginard, Nature 2002; 415:240-3). The discovery was based on the observation of cardiomyocytes in the processes of cell division in adult hearts. This was accomplished by immunohistochemical demonstration of cardiomyocyte-specific protein expression together with expression of cell cycle proteins and chemical markers of DNA replication (cardiac myosin, Ki67, and 5-bromodeoxyuridine, respectively). The latter two are indicators of actively dividing cells. Most cells of the adult heart are large, do not divide and are more likely than small myocytes to die by programmed cell death. Many of the less abundant small myocytes are dividing actively. These dividing cardiomyocytes also express the protein c-kit, which is an established marker of stem cells. Its expression on the cell surface allows for the separation of stem cells which express the protein (c-kit-positive cells) from non-stem cells that do not express c-kit (c-kit-negative cells). However, stem cells from other tissues – most notably bone marrow – also express c-kit and bone marrow-derived c-kit-positive cells can contribute to the repair of damaged myocardium (Orlic et al., Nature 2001; 410:701-5). The stem cells from bone marrow express distinct hematopoetic lineage markers which are not present in the stem cells isolated from cardiac tissue, which suggests strongly that cardiac stem cells are not derived directly from the bone marrow but are resident in the adult heart.

There are other characteristics of these cardiac stem cells, also known as progenitor cells. Human cardiac progenitor cells (HCPCs) can be obtained from samples of myocardium collected at surgery from human subjects. In addition to expressing the stem cell antigen c-kit, they are capable of self-renewal, so that these HCPCs replenish themselves in the heart. When isolated they display “clonogenicity,” meaning that a single HCPC can be expanded to produce a large number of identical undifferentiated cells. They also display multipotency, since HCPCs can be induced to differentiate into vascular smooth muscle and epithelial cells (which contribute to blood vessel formation), and cardiomyocytes; these are the major cell types of the heart and all are critical to recovery from a myocardial infarction. These properties have been established in vitro and in vivo (Beltrami et al. Cell 2003;114:763-6; Dawn et al. Proc. Natl. Acad. Sci U.S.A. 2005;102:3766-71). In xenograft-like experiments, injecting human cardiac progenitor cells into infarcted hearts of other species of mammals, human cells are found differentiated into the three cells types of the heart, as mentioned above. The myocardial tissue induced by HCPC injection contained myocytes, resistance arterioles, and capillary structures, although the myocytes resembled fetal-neonatal myocytes rather than adult myocytes. In addition, the area of the infarcted heart tissue was reduced when examined weeks and months after HCPC injection, compared to hosts which did receive HCPCs. Further genetic analysis to distinguish host from injected cells indicated that the regenerated myocytes and vessels did not result from cell fusion between the injected HCPCs and the host cells. Therefore, the injected cardiac stem cells contributed directly to restoration of the heart through differentiation, but also indirectly through an effect on the host’s own cardiomyocytes. Furthermore, it was observed that repair of damaged heart tissue was only partial, but cardiac function improved. Since the overarching goal of this work is to develop methods for the stable recovery of cardiac function after myocardial infarction, these results suggest a novel approach of injecting HCPCs to improve recovery in patients who have suffered heart attacks.

B. Neuroscience and Neuropsychology of Aging: Early Alzheimer’s Disease Memory Loss—An Attack on Synapses by Soluble Amyloid-Beta Oligomers?

Dr. William Klein, from Northwestern University, reviewed research on soluble amyloid-beta (Ab) oligomers and their involvement in the early memory loss associated with Alzheimer’s disease (AD).

The next generation of therapeutic approaches to AD will aim to modify the disease and neutralize the first steps in pathogenesis. Although there is no consensus on which mechanism to target, new approaches will be evaluated based on their ability to address a hallmark of early AD: The failure to form new memories. Accumulating evidence supports the hypothesis that memory loss is caused by soluble oligomers of Ab, which not only form toxic insoluble amyloid fibrils, but also soluble subfibrillar species the size of an average globular protein. These subfibrillar species are likely candidates for the hidden toxins related to AD memory loss, more so than toxic fibrils, as was hypothesized previously.

The formation of soluble Ab oligomers was first described by Lambert and colleagues (Proc. Natl. Acad. Sci. U S A. 1998 May 26; 95(11):6448–53). These oligomers can exist in the absence of fibrils, are toxic to the central nervous system, can produce dementia, and are small enough to escape detection by conventional neuropathology measures and electron microscopy. Lambert named these structures Ab-derived diffusible ligands (ADDLs). Brain slices chronically exposed to low doses of ADDLs show regionally selective nerve cell death in a manner consistent with the cognitive failures in AD; hippocampal neurons are vulnerable, cerebellar neurons are not.

The fact that ADDLs ultimately kill neurons underlies one aspect of their anticipated role in AD pathology. With respect to early AD memory loss, however, the most intriguing and significant impact of ADDL activity is a much faster ability to inhibit synaptic information storage. Memory formation begins at synapses, so one may suspect that the memory failure present in early AD begins at synapses as well. Indeed, several studies found that ADDLs suppress synaptic reinforcement in the hippocampus (Lambert et al., Proc. Natl. Acad. Sci. U S A 1998;95(11):6448–53; Wang et al., Biotechnol. Bioeng. 2002;80:50–9), and these and other studies (Walsh et al., Biochem. Soc. Trans. 2002;30:552–7; Nature 2002;416:535–9) led to an updated amyloid cascade hypothesis (Hardy and Selkoe Science 2002; 297:353–6) in which early memory loss results from synapse failure rather than neuron death, and synapse failure results from Ab oligomers, not amyloid fibrils. Advances in the past 3 years have shown that ADDLs constitute bona fide components of Alzheimer’s pathology (Gong et al., Proc. Natl. Acad. Sci.

U S A 2003;100:10417–22; Kayed et al. Science 2003;300:486–9); Lacor et al., J. Neurosci. 2004 Nov 10;24(45):10191–200). They occur in the human brain and are strikingly elevated in AD, particularly in the frontal cortex, and they are elevated by 1,000 percent in cerebrospinal fluid taken from patients with AD. Thus, the presence of ADDLs in cerebrospinal fluid could serve as a biomarker for AD diagnostics.

ADDLs bind specifically and with very high affinity to particular synapses. This binding appears to be mediated by certain synaptic proteins, although the identity of these proteins is unknown. In addition, ADDLs corrupt synaptic signaling pathways, particularly those associated with cytoskeletal mechanisms and, thereby, may alter the geometry of synaptic spines and reduce the number of neurotransmitter receptors. Contrast agents to detect ADDLs bound in the brain are under development.

Because ADDLs appear to effect long-term degeneration in addition to early-stage memory dysfunction, therapeutic approaches to AD should target ADDLs rather than the cellular molecules that generate or respond to them. Passive vaccines that specifically neutralize ADDLs are especially appealing and may circumvent the side effects and variable response associated with fibril-oriented vaccines, which address amyloid plaques, and secretase inhibitors, which lower the concentration of Ab. Efforts toward discovering small molecules that block oligomerization also appear to be feasible. Because ADDLs indirectly affect NMDA receptor signaling pathways, and because the AD drug, Namenda, is an NMDA receptor antagonist, new and more effective receptor-directed drugs may emerge from ADDL-based screens. Potentially therapeutic signaling effects of the omega-3 fatty acid DHA also may result from interactions with ADDL pathways. The search for specific ADDL receptors as potential drug targets is under way.

A Council member suggested that nerve cell death is the key neuropathological determinant of dementia in individuals with amyloid deposits. Dr. Klein noted that this possibility was consistent with his laboratory’s findings, because chronic exposure to ADDLs can kill particular neurons. He added, however, that critical anomalies in synaptic signal transduction or spine geometry could escape detection if they were not targets for assessment. Further study of how ADDLs affect memory is needed to guide such assessments.

C. Geriatrics and Clinical Gerontology: Caring for Older Patients with Multiple Comorbid Diseases—Clinical Practice Guidelines

In the presentation entitled, “Caring for Older Patients with Multiple Comorbid Diseases,” Dr.Cynthia M. Boyd of the Johns Hopkins University School of Medicine discussed recent work examining how clinical practice guidelines apply to and are feasible for older patients with multiple chronic diseases (Boyd CM, et al., JAMA 294:716–724, 2005).

Half of Medicare participants aged 65 and older have three or more chronic conditions, and this half of the older population is responsible for 89 percent of annual Medicare spending. While the Institute of Medicine has identified serious gaps in the quality of care for those with chronic diseases, a critical question remains: What does existing evidence reveal about how best to make decisions for older patients with multiple chronic diseases? Clinical practice guidelines (CPGs) are developed for the management of a specific disease and are intended to synthesize and grade the evidence to guide recommendations for clinical practice. Thus, they are intended to influence practice and, while not their intent, often are used as quality-of-care benchmarks. (Garber AM Health Aff. (Millwood), 2005; 24:174–179). However, there is little evidence on applicability to older persons with multiple diseases. (Tinetti et al., NEJM 2004; 351:2870–2874).

Dr. Boyd presented research that aimed to answer the following two questions: In older adults with multiple chronic conditions, (1) are CPGs applicable? and (2) what does it mean for the patient if health care providers try to follow CPGs? The National Health Interview Survey and a nationally representative sample of Medicare beneficiaries were used to identify the most prevalent chronic diseases in this population. Of the 15 most common chronic diseases, Boyd and colleagues selected hypertension, chronic heart failure, stable angina, atrial fibrillation, hypercholesterolemia, diabetes mellitus, osteoarthritis, chronic obstructive pulmonary disease, and osteoporosis, which usually are managed in primary care. Two investigators independently assessed whether each CPG addressed older patients with multiple comorbid diseases, the quality of the evidence, goals of treatment, interactions between recommendations, burden to patients and caregivers, patient preferences, life expectancy and time needed to treat in order to achieve benefit, and quality of life. Differences were resolved by consensus.

Most CPGs did not modify or discuss the applicability of the recommendations for older patients with multiple comorbidities. Few addressed older patients with multiple comorbid diseases. The majority of the guidelines discussed the quality of evidence for older patients, but few discussed evidence for those with multiple comorbid diseases as well. The atrial fibrillation and chronic heart failure guidelines noted the absence of older patients in clinical trials in representative numbers. The diabetes guideline noted the lack of evidence guiding the care of older patients or patients with limited life expectancy and the fact that the benefits of tight glycemic control may be realized only after more than 5 years. Most guidelines mentioned quality of life but did not comment on the burden to patients or caregivers or short- and long-term goals, nor was there guidance for incorporating patient preferences into treatment plans.

Dr. Boyd’s team generated an aggregate treatment regimen for a hypothetical patient (79-year-old woman with five chronic conditions of moderate severity,i.e.,chronic obstructive pulmonary disease, hypertension, diabetes mellitus, osteoporosis, and osteoarthritis) by combining the relevant CPGs. The team followed explicit instructions when available, chose once-a-day dosing when available, assumed generic drugs when available, took advantage of potential synergies between CPGs, and chose medicines with the least adverse effects. If the relevant CPGs were followed, the hypothetical patient would be prescribed 12 medications (costing her $406 per month from a low-cost, online pharmacy) and a complicated nonpharmacological regimen. Adverse interactions between drugs used to treat these five diseases could result, of varying clinical significance.

This research question is critically important for an aging population because of several factors, including an increasing prevalence of chronic diseases with maintenance regimens and the prevalence of care from multiple sources. Caring for older patients with multiple chronic diseases is a challenging issue for providers and also has consequences for patients and caregivers. Adherence to treatment regimens is known to decrease in the setting of multiple medications, depression, or cognitive impairment. Adhering to current CPGs in caring for an older person with several comorbidities may have undesirable effects. Basing standards for quality of care and pay for performance on existing CPGs could lead to inappropriate judgment of the care provided to older individuals with complex comorbidities and could create perverse incentives that could diminish the quality of their care. Determining how to make clinical decisions most appropriately for patients with multiple diseases and then developing measures of the quality of the care needed by these patients are critical to improving their care. This may require a shift to thinking more about patients with multimorbidity, who have varying circumstances and preferences, as opposed to considering comorbidity from the perspective of an index condition for some research questions.

D. Behavioral and Social Research: Geography and Racial Health Disparities

Dr. Amitabh Chandra from the John F. Kennedy School of Government, Harvard University, presented findings that associate geography with the quality of care received by Medicare beneficiaries and with racial health disparities identified in research supported through an NIA program project grant led by Dr. Jonathan Skinner. Dr. Chandra began with the observation of large geographic variation in the use of technologically intensive health care services and of quality of care received by Medicare beneficiaries. More care does not seem to be associated with improved survival. Economists, therefore, question whether some areas spend too much. In addition, areas that use technologically intensive and costly interventions systematically make less frequent use of effective and accepted conventional measures, such as beta blockers or aspirin after a heart attack and regular eye exams for patients with diabetes. The data show that higher spending is associated with lower quality of care and greater spending on end-of-life care (Baicker and Chandra, Health Affairs [Web Exclusive], April 7, 2004). Increased spending by $1,000 per Medicare beneficiary is actually associated with a decrease in the percent receiving accepted conventional measures that are known to be effective but does not seem to be associated with higher levels of patient satisfaction.

One mechanism for this tradeoff may be the composition of the provider workforce: States with more general practitioners use more effective care and have lower spending, whereas, those with more specialists have higher costs and lower quality. This is not to say that specialization is undesirable. Patients who receive care in a hospital’s field of specialization receive high-quality intensive care and treatment, and have a higher rate of survival. The probability of survival is expected to be higher in patients for whom intensive treatment is more appropriate. For example, across all areas, there is no relationship between cardiac catheterization usage and outcomes. In areas where this more aggressive treatment is pervasive, patients not clinically appropriate for cardiac catheterization are, on average, worse off. This suggests that intensive management crowds out medical management, and patients who would benefit from effective and less intensive procedures suffer. Thus, areas that spend more money on specialists tend to have poor medical management of patients. Dr. Chandra contended that improving the quality of beneficiaries’ care could be accomplished with more effective use of existing dollars. Currently, much of the spending in the highest-spending regions goes toward specialist consultations, inpatient visits, electroencephalograms, pulmonary function tests, and end-of-life procedures.

In examining the interaction between geography and racial health disparities, Dr. Chandra and his colleagues noted that even when whites and blacks live in the same area, they go to very different hospitals; thus, differences in hospital quality cannot be ruled out as the cause of any observed differences in treatment. Dr. Chandra noted that blacks in the sample were not significantly sicker than whites. The investigators, therefore, looked for differences in the quality of treatment when whites and blacks were treated at the same hospital. In terms of the treatment of a relatively common condition such as a heart attack, 60 to 65 percent of the racial disparity (in 90-day mortality after heart attack) can be eliminated simply by controlling hospital quality. Researchers project that if blacks went to the same hospitals as whites, mortality among blacks would fall by one percentage point (from 23.3 percent to 22.3 percent), which would translate into saving the lives of 150 blacks per year in the Medicare population alone (assuming that there are 15,000 acute myocardial infarctions per year in the Medicare population).

Geographic disparity in health care is a local phenomenon such that racial disparities are not consistent across different types of treatment. Some geographical areas specialize in one treatment area, which may compromise services in other treatment areas as they decline in focus. In reviewing the literature on geography and racial health disparities, Dr. Chandra and his colleagues determined that it is more productive to focus on the 1,000 or so hospitals where the action centers because of residential clustering rather than to pursue a broader examination of all hospitals in the country.

One Council member observed that geography can be a marker for many factors. It is important to understand the etiology of the disparities so that effective interventions can be crafted. For example, if outcomes are determined heavily by what happens in the first 30 to 90 minutes after a patient presents at the emergency room, then hospitals that are under-resourced cannot respond adequately to demands, and these hospitals could be in geographical locations that have not been allocated sufficient resources to respond.

Dr. Chandra was not convinced that disparities in one sphere of human life (e.g., education) necessarily connect to another sphere of human life (e.g., health). Although he did not question that things can be improved with more money, he underscored the uncertainty in terms of where marginal dollars are spent. If they are spent on the wrong kinds of health care, such as more specialist consultations at a patient’s deathbed, then this is not the kind of approach known to be effective in prolonging life. This explains the negative association between quality and spending. If extra money is spent on what is known to be effective care or the kind of care that actually is grounded in good medicine, then putting more money into these hospitals definitely will begin to address the problem. This issue is complicated, because treatments are more likely to be prescribed if they are most highly reimbursed.

IX. ADJOURNMENT

The 96th meeting of the National Advisory Council on Aging was adjourned at 2:00 p.m. on September 28, 2005. Dr. Hodes closed the Council session by thanking all speakers and the Council members for their participation. The next meeting is scheduled for January 31 to February 1, 2006.

Attachments:

• Roster of Council Members
• Director’s Status Report to the National Advisory Council on Aging

X. CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachments are accurate and complete.4

Richard J. Hodes, M.D.
Chairman, National Advisory Council on Aging
Director, National Institute on Aging

Prepared by Miriam F. Kelty, Ph.D.
With assistance by Rose Li and Associates, Inc.

MEMBERSHIP ROSTER
NATIONAL ADVISORY COUNCIL ON AGING
NATIONAL INSTITUTE ON AGING
(Terms end December 31) (*WGoP Member)

Chairperson
Richard J. Hodes, M.D.
Director, National Institute on Aging
National Institutes of Health
Bethesda, MD

Marie A. Bernard, M.D. (2005)
Donald W. Reynolds Chair
Department of Geriatric Medicine
University of Oklahoma College of Medicine
Oklahoma City, OK

Elizabeth H. Blackburn, Ph.D. (2006)
Professor
Dept of Biochemistry & Biophysics
University of California
San Francisco, CA

Melissa M. Brown, M.D. (2006)
Director
Center for Value-Based Medicine
Flourtown, PA

*John T. Cacioppo, Ph.D. (2007)
Blake Distinguished Service Professor
Department of Psychology
Director, Center for Cognitive and Social Neuroscience
University of Chicago
Chicago, IL

*Linda P. Fried, M.D., MPH (2006)
Professor, Medicine, Epidemiology & Health Policy
Director, Division of Geriatric Medicine &
Gerontology
Director, Center on Aging and Health
The Johns Hopkins Medical Institutions
Baltimore, MD

Alan M. Garber, M.D., Ph.D. (2007)
Director
Center for Primary Care and
Outcomes Research
Center for Health Policy
Stanford University
Stanford, CA

F. Michael Gloth, III, M.D., (2005)
President
Victory Springs Senior Health Care
Reisterstown, MD

Paul Greengard, Ph.D. (2008)
Vincent Astor Professor
Laboratory of Molecular & Cellular Neuroscience
The Rockefeller University
New York, NY

*Eugene M. Johnson, Jr., Ph.D. (2005)
Norman J. Stupp Professor, Department of Neurology
Professor, Dept. of Molecular Biology & Pharmacology
Co-Director, Alzheimer's Disease Research Center
Washington University School of Medicine
St. Louis, MO

Ronald D. Lee, Ph.D. (2005)
Jordan Family Chair of Economics
Professor, Demography and Economics
Director, Center on Economics and
Demography of Aging
University of California
Berkeley, CA

*Virginia M.-Y. Lee, Ph.D. (2007)
Professor
Dept of Pathology & Laboratory Medicine
Univ of Pennsylvania School of Medicine
Philadelphia, PA

Spero M. Manson, Ph.D. (2006)
Professor of Psychiatry and Head
American Indian & Alaska Native Programs
University of Colorado Health Sciences Ctr
Aurora, CO

Mills, Terry L., Ph.D. (2008)
Associate Dean for Minority Affairs
and Special Programs
Office for Academic Support
and Institutional Services
University of Florida
Gainesville, FL
Peter W. Nauert, J.D. (2005)
Principal
Insurance Capital Management
Fort Worth, TX

Gary B. Ruvkun, Ph.D. (2007)
Professor, Molecular Biology
Massachusetts General Hospital
Boston, MA

Albert L. Siu, M.D., M.S.P.H. (2008)
Ellen and Howard C. Katz Professor
Chairman, Brookdale Department
of Geriatrics and Adult Development
Mount Sinai School of Medicine
The Mount Sinai Medical Center
(and Director, Geriatric Research, Education, and Clinical Center, Bronx Veterans Administration)
New York, NY

*Leon J. Thal, M.D. (2005)
Professor and Chair
Department of Neurosciences
University of California San Diego
School of Medicine
(and Staff Physician, Neurology Service,
San Diego Veterans Medical)
La Jolla, CA

Mary E. Tinetti, M.D. (2008)
Gladys Phillips Crofoot Professor
Department of Internal Medicine, Epidemiology, and Public Health
Director, Program on Aging
Yale University School of Medicine
New Haven, CT

EX OFFICIO MEMBERS

Michael O. Leavitt Kenneth G. Pugh, M.D.
Secretary Commander, MC, U.S. Navy
Department of Health and Human Services Department of Medicine
Hubert H. Humphrey Building National Naval Medical Center
Washington, D.C. Bethesda, MD

Elias Zerhouni, M.D. John Wren
Director Director, Center for Planning & Policy Development
National Institutes of Health U.S. Administration on Aging, DHHS
Public Health Service Washington, D.C.
Bethesda, Maryland

James F. Burris, M.D.
Chief Consultant
Geriatrics & Extended Care Strategic
Healthcare Group
Department of Veterans Affairs
Washington, D.C.

For the record, it is noted that members absented themselves from the meeting when the Council discussed applications (a) from their respective institutions or (b) in which a conflict of interest may have occurred. This procedure only applied to applications that were discussed individually, not to “en bloc” actions. Return to text.

See General Guidance About SAO Reporting and Divestiture Requirements for the definition of Substantially Affected Organization: http://ethics.od.nih.gov/Topics/SAO/sao-guidance.htm Return to text.

These minutes will be approved formally by the Council at the next meeting on January 31 to February 1, 2006, and corrections or notations will be stated in the minutes of that meeting. Return to text.