National Diabetes and Digestive and Kidney Diseases Advisory Council
May 12, 2010
I. CALL TO ORDER
Dr. Griffin P. Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) called to order the 183rd meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council at 8:30 a.m., Wednesday, May 12, 2010, in Building 31, C Wing, 6th Floor, Conference Room 10, NIH Campus, Bethesda, Maryland.
Dr. Rodgers Elections to the National Academy of Sciences Dr. Rodgers reported on the recent election to the National Academy of Sciences of one NIDDK intramural scientist and several NIDDK grantees.
Division of Intramural Research
Attila Szabo, Ph.D., Laboratory of Chemical Physics, Theoretical Biophysical Chemistry Section. Attila Szabo, has conducted research at NIDDK for almost 30-years and is considered one of the world’s leading theorists in the biophysical sciences. In addition to being elected to the National Academy of Sciences, he has been elected to the American Academy of Arts and Sciences, a prestigious institution composed of highly regarded scholars and accomplished individuals. A hallmark of Dr. Szabo’s research is the study of the close relationship between theory and experiment. He has made important contributions in elucidating the dynamics of ligand binding to proteins and receptors on cell surfaces and the analysis of probes monitoring fluorescence depolarization and nuclear magnetic relaxations in both macromolecules and membranes. Dr. Szabo is best known for his model-free approach for the interpretation of nuclear magnetic resonance experiments. His pioneering paper on this subject has been cited more than two thousand times.
Division of Diabetes, Endocrinology and Metabolic Diseases (DEM)
Roger Cone, Ph.D., Professor and Chair of the Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine. Before joining Vanderbilt University in 2008, Dr. Cone had spent much of his career at the Oregon Health and Science University. His research focuses on how the central nervous system regulates energy stores. He has specifically concentrated on the melanocortin system and its control of feeding and metabolism. Dr. Cone has been an NIDDK grantee for more than twenty years.
Robert Fletterick, Ph.D., Professor of Biochemistry, Department of Biochemistry and Biophysics, University of California, San Francisco, School of Medicine. Dr. Fletterick has wide-ranging scientific interests. For example, his laboratory solved the first structure of a nuclear receptor bound to its hormone. His laboratory also solved the structure of the molecular motor kinesin found in nerve cells, showing that it is related to the well-known myosin motor protein of muscle. Presently, his laboratory is studying hormone receptors that regulate neurodevelopment, embryogenesis, steroid metabolism, prostate development, and cancer. Projects are also underway in regenerative medicine and stem cell science. Dr. Fletterick has been supported by NIDDK for different projects for more than thirty years. He also has substantial support from several other NIH Institutes (including the National Cancer Institute, National Institute of General Medical Sciences, and National Institute of Arthritis and Musculoskeletal and Skin Diseases).
Richard Van Duyne, Ph.D., the Charles E. and Emma H. Morrison Professor of Chemistry, Department of Chemistry, Northwestern University. Dr. Van Duyne is a long-time National Science Foundation grantee and is presently funded by NIDDK to work on a new in vivo glucose sensor technology.
Division of Digestive Diseases and Nutrition (DDN)
Ruslan Medzhitov, Professor of Immunobiology, Yale School of Medicine, and a Howard Hughes Medical Institute Researcher. Dr. Medzhitov currently has an R01 grant from NIDDK investigating the role of commensal microorganism and Toll-like receptor interactions in the maintenance of intestinal homeostasis, tissue protection and repair, and the pathogenesis of inflammatory bowel disease.
Division of Kidney, Urologic and Hematologic Diseases (KUH)
Vann Bennett, M.D., Ph.D., a Howard Hughes Medical Institute Investigator, and James B. Duke Professor of Cell Biology, Departments of Cell Biology, Biochemistry, and Neurobiology, Duke University Medical Center. Dr. Bennett has devoted much of his scientific career to the study of red blood cell membrane proteins. This work led him to discover “ankyrin”--the first known molecular connection between a membrane ion transporter and the cytoskeleton. He then went on to discover that ankyrin organizes specialized membrane domains in many cells in the body, ranging from excitable membranes in the heart and nervous system to epithelial cells, photoreceptors in the eye, and striated muscle. Dr. Bennett was a long-time NIDDK MERIT awardee before becoming an HHMI Investigator.
NIH Obesity Research Task Force Dr. Rodgers informed the Council about activities of the NIH Obesity Research Task Force, which he co-chairs. The Task Force is developing a new Strategic Plan. Since the initial Strategic Plan was published in 2004, there has been considerable progress in obesity research--much of which has been supported by NIDDK and other NIH Institutes and Centers. The new Plan will reflect the current challenges and exciting scientific opportunities that have emerged. The draft encompasses research on discovering biological mechanisms regulating energy balance; understanding correlates, determinants, and consequences of obesity; designing and testing interventions; disseminating and implementing research; improving measurement tools, technology, and methods; and moving research findings into practice. To gather external input, the NIH sent out an initial working draft in April to scientists in obesity-related research fields-- including some members of the NIDDK National Advisory Council--as well as to voluntary and professional health organizations. A revised draft will soon be posted on the NIH website for a public comment period. Dr. Rodgers recognized the contributions of NIDDK Program Director, Dr. Christine Hunter, as well as the work of many other individuals who are providing support for this planning effort. It is expected that the final version of the Strategic Plan will be available in the fall of 2010.
II. CONSIDERATION OF SUMMARY MINUTES OF THE 182nd COUNCIL MEETING
Following a motion, the Council approved by voice vote the Summary Minutes of the 182nd Council meeting.
III. FUTURE COUNCIL DATES
Dr. Rodgers asked the Council to review the following upcoming meeting dates.
September 22-23 (Wednesday and Thursday)
February 16-17 (Wednesday and Thursday)
May 11-12 (Wednesday and Thursday)
September 7-8 (Wednesday and Thursday)
February 15-16 (Wednesday and Thursday)
May 16-17 (Wednesday and Thursday)
September 12-13 (Wednesday and Thursday)
While most meetings are expected to be a single day (Wednesday), Dr. Rodgers asked Council members to reserve the following day (Thursday) to ensure flexibility in the case that a situation arises where a longer meeting is required.
Dr. Rodgers reminded Council members that NIDDK’s 60th Anniversary celebrations will culminate on Tuesday, September 21, 2010 (the day before the next Council meeting), with the NIDDK Anniversary Scientific Symposium on the NIH campus and the 60th Anniversary Celebratory Dinner later that evening at the Bethesda North Marriott Hotel and Conference Center.
Dr. Stanfield Confidentiality Dr. Stanfield reminded Council members that material furnished for review purposes and discussion during the closed portion of the meeting is considered confidential. The content of discussions taking place during the closed session may be disclosed only by the staff and only under appropriate circumstances. Any communication from investigators to Council members regarding actions on an application must be referred to the Institute. Any attempts by Council members to handle questions from applicants could create difficult or embarrassing situations for the members, the Institute, and/or the investigators.
Conflict of Interest Dr. Stanfield underscored that advisors and consultants serving as members of public advisory committees, such as the NIDDK National Advisory Council, may not participate in situations in which any violation of conflict of interest laws and regulations may occur. Responsible NIDDK staff shall assist each Council member to help ensure that the member does not participate in and is not present during review of applications or projects in which, to the member’s knowledge, any of the following has a financial interest: the member, or his or her spouse, minor child, partner (including close professional associates), or an organization with which the member is connected.
Dr. Stanfield noted that, at Council meetings at which applications are reviewed in groups without discussion, that is, “en bloc” action, all Council members may be present and may participate. The vote of an individual member in such instances does not apply to applications for which the member might be in conflict. Regarding multi-campus institutions of higher education, Dr. Stanfield pointed out that an employee may participate in any particular matter affecting one campus of a multi-campus institution of higher education, if the employee’s financial interest is solely employment in a position at a separate campus of the same multi-campus institution, and the employee has no multi-campus responsibilities.
To ensure that a Council member does not participate in the discussion of, nor vote on, an application in which he/she is in conflict, a written certification is required. A statement is provided for the signature of the member, and this statement becomes a part of the meeting file. Dr. Stanfield directed each Council member to his or her folder containing a statement regarding conflict of interest in his or her review of applications. He asked each Council member to read the statement carefully, sign it, and then return the signed statement to NIDDK prior to leaving the meeting.
V. REPORT FROM THE NIDDK DIRECTOR
Changes in Reprogramming Procedures Dr. Rodgers reminded the Council of two changes in the process for reprogramming funds among budget mechanisms--a topic that he had discussed at the February 2010 Council meeting. First, to move funds among budget mechanisms, the NIDDK and other Institutes will need to prepare reprogramming requests with much greater specificity. With the exception of research project grants, these requests must address subsets of budget mechanisms rather than overall totals for the major categories. For example, for a formal reprogramming of $500,000 into or out of the research training mechanism, details would need to be provided at the sub-mechanism level about specific programs to be affected, for example, institutional or individual National Research Service Awards. Second, based on the current understanding of the Antideficiency Act, the Institute will be restricted from moving funds in either direction between external budget mechanisms (such as extramural grants and contracts) and internal budget mechanisms (such as the Intramural Research Program and the Research Management and Support category) without notifying the Congress 15 days in advance.
Moreover, in April 2010, the Government Accountability Office determined that reprogramming violations can constitute violations of the Antideficiency Act. In those cases, agency heads will be required to report such violations to the President and the Congress. The NIH Office of Budget has advised NIH components to submit to central NIH by June 15, 2010, all requests for reprogramming funds through September 30, 2010, in order to permit adequate time for consideration by the Department, the Office of Management and Budget and the Congress. To meet these new requirements, the NIDDK will carefully monitor the need for budget adjustments.
Appropriations Process The NIH Director, Dr. Francis Collins, has testified on the President’s Fiscal Year 2011 budget request for the NIH before the House and Senate Subcommittees on Labor, HHS, Education and Related Agencies, on April 28 and May 5, respectively. In his testimony, Dr. Collins recounted recent NIH-funded discoveries and advances, the pursuit of unique opportunities made possible with funds provided by the American Recovery and Reinvestment Act (ARRA), and examples of NIH research priorities for Fiscal Year 2011. Regarding Fiscal Year 2011 success rates, Dr. Collins noted at the House hearing that they are projected to be on the order of 15 percent. This projection takes into consideration inflationary increases in research costs, which are expected to exceed the funding increase in the proposed budget.
Dr. Rodgers said that he was pleased to accompany the NIH Director for his House testimony, along with the NIAID Director, Dr. Tony Fauci, and the NIMH Director, Dr. Thomas Insel. Dr. Rodgers was given the opportunity to respond positively to several questions, including one related to comparative effectiveness research. He also elaborated on the success of partnering with non-governmental organizations to translate the important research discovery that increased physical activity can prevent or delay the onset of type 2 diabetes in those at risk. These findings emerged from the NIDDK’s Diabetes Prevention Program clinical trial and follow-up study. In a pioneering step for the health insurance industry, the United Health Group has launched a diabetes prevention and control alliance in partnership with the YMCA and Walgreens to translate these scientific findings to community settings by delivering the interventions in a cost-effective way. The United Health Group will cover these services at no charge to participants in its health plan in six cities. This partnership is a milestone in evidence-based diabetes prevention programs.
Dr. Rodgers noted that, after deliberations and possible changes at the subcommittee and full committee levels, House-passed and Senate-passed versions of the appropriations bill are typically reconciled in a conference bill that is then passed in identical form by both chambers and sent to the President for signature before the end of the Fiscal Year. Dr. Rodgers reminded the Council that the President’s Fiscal Year 2011 budget request for the NIDDK is approximately $50 million above the Institute’s Fiscal Year 2010 enacted budget level--about a 2.6 percent increase. These figures are exclusive of funding under the American Recovery and Reinvestment Act (ARRA), but inclusive of funds for the wide Special Statutory Funding Program for Type 1 Diabetes Research, which the NIDDK manages.
American Recovery and Reinvestment Act (ARRA) Dr. Rodgers reported that, to date, the NIDDK has obligated or committed a total of $365.7 million or 82 percent of its $445.4 million in ARRA funding. He noted that the NIDDK plans to spend the remaining funds on a number of activities including R56 awards, R24 grants, RC4 grants, and administrative supplements. He reminded the Council that the two-year ARRA funding program ends September 30, 2010.
Special Statutory Funding Program for Type 1 Diabetes Research Bills have been introduced in both the House and Senate (HR. 3668 and S. 3058, respectively) to extend the Special Statutory Funding Program for Type 1 Diabetes Research from 2012 through 2016, along with a parallel diabetes prevention and treatment program for Native Americans administered by the Indian Health Service (IHS). Absent this legislation, these programs are slated to end September 30, 2011. The bills would provide each agency with a total of $1 billion over the five-year period covered. There is already considerable co-sponsorship of the bills, which were introduced by Rep. Diana DeGette (CO) and Senator Byron Dorgan (ND).
VI. NEW OPPORTUNITIES FOR BEHAVIORAL AND SOCIAL SCIENCE RESEARCH AT NIH
Dr. Gregory Germino, Deputy Director Dr. Germino described a trans-NIH initiative--the Basic Behavioral and Social Science Opportunity Network--OppNet (http://oppnet.nih.gov). Basic behavioral and social science research is defined as research that furthers understanding of fundamental mechanisms and patterns of behavioral and social functioning relevant to the Nation’s health and well-being, and as they interact with each other, with biology, and the environment.
Goals of OppNet and Its Importance to NIDDK The goals of OppNet are to support activities and initiatives to focus on basic mechanisms of behavior and social processes and to expand NIH funding for this research area. There are three major categories of research addressed by OppNet: (1) behavioral and social processes--e.g., group processes, learning, social cognition, emotion/motivation, (2) biopsychosocial research, including the study of interactions of biological factors with behavioral or social variables, such as genetic-environmental interactions with behavior, psychosocial stress and disease; the interaction of circadian sleep rhythms and behavior; and the effects of social networks on the spread of disease, and (3) data collection, modeling, and research design, including the development of better methodologies and tools.
Dr. Germino noted the importance of briefing the Council on this initiative because of its trans-NIH scope, the impact, albeit modest, it will have on NIDDK’s planed funding, and the likelihood that the Council will need to review some projects for potential funding. Importantly, NIDDK grantees need to be made aware of the program and encouraged to avail themselves of the research and funding opportunities it presents.
OppNet as a Means of Addressing Poor Health Behaviors Dr. Germino pointed out that OppNet can be an important means of addressing poor health behaviors. Research has shown that health in the U.S. is influenced by factors in five domains: genetic predisposition, social circumstances, environmental exposure, health care, and behavioral patterns. Behavioral patterns account for approximately 40 percent of the increased risk for premature death (Schroeder, et al. We Can Do Better Improving the Health of the American People. NEJM 357:1221-1228, 2007). Therefore, even optimal health care for the entire U.S. population would have only a modest impact on premature death--absent changes in behavior. Research studies have already demonstrated effective behavioral approaches to reduce the risk of type 2 diabetes, obesity and hypertension--key research areas supported within the NIDDK mission. However, the American public and its health practitioners are not yet fully embracing sound, science-based advice for healthy behaviors, such as moderating food intake, increasing physical activity, and reducing salt in the diet.
Dr. Germino noted that the gulf between the availability of evidence-based proof-of-efficacy for behavioral interventions and their successful clinical implementation in the real world can be described as a “second valley of death.” The first “valley of death” is the gulf that exists between demonstrating “proof-of-concept” for an intervention in the laboratory and then bringing it to a clinical setting where it can directly benefit patients. Both of these gulfs are “valleys of death” in translational research and medicine.
The NIH has long supported different approaches to bridge the second translational gulf on the research continuum, including educational programs for patients and medical/health practitioners. The NIDDK has contributed to these efforts through such programs as the National Diabetes Education Program, the National Kidney Disease Education Program, and the Institute’s three national information clearinghouses. In the same vein, the NIH has supported behavioral research, including the study of approaches that can help motivate people to follow treatment guidelines. Yet, for behavioral approaches, there has not yet been optimal implementation of evidence-based proof-of- efficacy into clinical practice.
The OppNet program is aimed at addressing this translational issue by broadening the scope of behavioral research to include a new focus on studies that will provide a deep understanding of behavioral and social processes. Just as an increased understanding of the fundamentals of biology can inform disease-focused research, so too can insights into fundamental behavioral and social processes inform the adoption of behaviors that have been demonstrated by research to be effective in improving human health.
Funding of OppNet Dr. Germino described the funding expectations for the trans-NIH OppNet program and the impact that NIDDK’s participation will have on the Institute’s budget. The estimated total funding for this program is $12 million in FY 2010, $20 million in FY 2011, and $30 million for each of the Fiscal Years 2012 through 2014. In FY 2010, $10 million will come from Office of the NIH Director from ARRA funds and $2 million from HIV-AIDS specific funds. From Fiscal Years 2011 through 2014, funding will be from the various NIH components that support extramural research. Contributions will be calculated as a percentage of each organization’s base appropriation. The NIDDK will contribute about $1.2 million in FY 2011 and $1.8 million annually from FY 2012 through FY 2014.
For FY 2010, the NIH will fund meritorious applications that have been received in response to a series of already published funding opportunity announcements, including competitive revisions to existing grants and short-term training opportunities that were consistent with the time-sensitive use of ARRA funds. For FY 2011 and beyond, the NIH has solicited ideas for new initiatives from both within and outside of the NIH community. For example 320 responses were received in response to a Request for Information for web-based input. Based on the response, the NIH is now developing funding opportunity announcements for FY 2011 that will be posted by mid-summer 2010, with a late fall submission date. In addition, the NIH will sponsor a large conference in the fall of 2010 to obtain broad input for the development of OppNet plans for FY 2012 and beyond.
In closing, Dr. Germino encouraged the Council members to review the OppNet website and to inform their colleagues about the program. He acknowledged the efforts of NIDDK staff members Drs. Christine Hunter, Sue Yanovski and Phil Smith in representing the NIDDK on the various committees guiding OppNet’s development.
Questions and Discussion Will OppNet be funded with new, additional funds provided specifically for the program, or must program costs be absorbed within existing budgets? Dr. Germino replied that funding will be from existing budgets. That is one reason that NIDDK grantees need to be aware of the program and take advantage of its funding opportunities.
What will NIH do to overcome human resource issues with respect to obtaining the broadest possible range of research applications and having the staff expertise to address them? What steps will NIH take to reach out to the full community of behavioral research and social science researchers--many of whom may not be engaged in health research or familiar with NIH funding announcements and processes? Dr. Germino replied that there has been extensive discussion regarding these issues among NIH staff members, the behavioral and social science communities, and their advocacy groups. The NIH is seeking very broad representation and participation in this initiative. For example, one goal for the fall meeting is to engage a wide spectrum of individuals from many relevant disciplines, including behavioral economics, so that the program is developed in a comprehensive manner.