- I. CALL TO ORDER AND OPENING REMARKS – Dr. Elizabeth G. Nabel
- II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST – Dr. Elizaeth G. Nabel
- III. REPORT OF THE DIRECTOR – Dr. Elizabeth G. Nabel
- IV. GLOBAL HEALTH AND CHRONIC DISEASES – Dr. Salim Yusuf
- V. COMPARATIVE EFFECTIVENESS RESEARCH: VIEW FROM THE NHLBI – Dr. Michael S. Lauer
- VI. VI. ENHANCING PEER REVIEW: UPDATE – Dr. Stephen C. Mockrin
- VII. RESEARCH DESIGNED FOR CHILDREN – Ms. Victoria Pemberton
- VIII. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL STUDIES – Dr. Carl Roth
- IX. ANNUAL REVIEW OF DELEGATED AUTHORITIES – Dr. Stephen C. Mockrin
- X. REVIEW OF APPLICATIONS
Dr. Elizabeth Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 233rd meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
New NIH Leadership:
Dr. Nabel announced changes in the NIH leadership:
- Dr. Raynard S. Kington was named Acting Director of the NIH on October 31, 2008, following the departure of Dr. Elias Zerhouni. Dr. Kington has served as NIH Deputy Director for the past 6 years.
- Dr. Lawrence Tabak, Director of the National Institute of Dental and Craniofacial Research (NIDCR), NIH, is now also serving as Acting Deputy Director, NIH.
Dr. Nabel announced two changes in the NHLBI leadership:
- Dr. Keith Hoots joined the Institute in January as the Director of the Division of Blood Diseases and Resources, where he will guide the Institute's program on the causes, prevention, and treatment of nonmalignant blood diseases; blood resources; stem cell biology; and cell-based therapies. Dr. Hoots was Professor of Pediatrics and Division Head, Pediatric Hematology, University of Texas Medical School at Houston; Section Head, Pediatric Hematology, The University of Texas M.D. Anderson Cancer Center; and Medical Director, Gulf State Hemophilia and Thrombophilia Treatment Center.
- Ms. Sally McDonough has accepted the position of Director of the new NHLBI Office of Communications and Legislative Activities. Initially, she will help the Institute develop a comprehensive, strategic communications plan. Ms. McDonough served as Director of Communications and Press Secretary to former First Lady Laura Bush.
The Council was reminded that under Public Law 92-463, the Federal Advisory Committee Act, a portion of the meeting would be closed to the public, for the consideration of grant applications. A notice of this meeting was published in the Federal Register indicating that it would not be open to the public. Dr. Nabel also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.
The NIH is operating on a Continuing Resolution through March 6, 2009, which means it is operating at FY 2008 levels. The FY 2008 NIH appropriation was $29.61 billion. In FY 2008, 84.2 percent of the total NIH budget (not including $150 million from a supplemental appropriation in June 2008) supported over 325,000 extramural scientists and research personnel at more than 3,000 institutions nationwide.
Several alternative budget levels are being considered for the NIH for FY 2009. The FY 2009 President's Budget Request (excluding impact of the Economic Recovery legislation) is $29.46 billion (0.5 percent less than the FY 2008 appropriation). The House and Senate budget versions (also excluding impact of the Economic Recovery legislation) are for $30.38 billion and $30.26 billion, respectively.
Dr. Nabel reviewed the FY 2009 NHLBI budget, which is currently $2,922,928,000 under the Continuing Resolution. She acknowledged the trade-off between competing and noncompeting research project grants (RPGs) that occurs in tight budgetary times. Currently, the Institute's payline for traditional research project grants (R01s) is at the 12.0 percentile; at the 17.0 percentile for new investigators; and at the 22.0 percentile for early stage investigators (if expedited administrative review resolves summary statement comments). The Institute begins each fiscal year with a conservative payline, which usually improves during the year.
Economic Recovery Bill:
Dr. Nabel discussed components of the Economic Recovery legislation (i.e., American Recovery and Reinvestment Act of 2009) under consideration by Congress that would affect the NIH. (Note: At the time of the NHLBAC meeting, the legislation was not final. Since then, both House and Senate have passed legislation that provides $10 billion for the NIH to support jobs and economic growth through the scientific enterprise.)
Early Stage Investigators/New investigators:
Dr. Nabel updated the Council on the NIH Policy for New and Early Stage Investigators.
New Investigator : An individual who has not previously competed successfully as a principal investigator for a significant NIH independent research award.
Early Stage Investigator (ESI) : An individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).
Over the past 3 years, approximately 25 percent of NIH competing R01 awards have been made to New Investigators. For FY 2009, NIH Institutes/Centers are directed to maintain comparable success rates for New Investigators and established investigators submitting new (Type 1) grant applications. With this approach, the NIH anticipates making approximately 1,650 R01 awards to New Investigators in FY 2009. (The NHLBI goal is 202 R01 awards to New Investigators.) A majority of the New Investigator pool will be ESIs.
The NHLBI has modified its funding policy for New Investigators for FY 2009. The payline for Type 1 R01s for both ESIs and New Investigators who are not ESIs is 5 percentile points above the regular R01 payline. In addition, ESIs (but not non-ESI New Investigators) will have an opportunity for Expedited Administrative Review to resolve comments in the summary statement if their application is more than 5 percentile points, but not more than 10 percentile points, above the regular R01 payline.
Recent NHLBI data indicate that the Institute is successfully supporting New and Early Stage Investigators. Over the October 2008 and February 2009 NHLBAC rounds, the success rate for established investigators submitting Type 1 grant applications was 13.0 percent, while the comparable success rate for New and Early Stage Investigators was 12.5 percent. ESI investigators were 67 percent of the funded overall New and Early Stage Investigator group.
NIH policy is in place for investigators who wish to request an extension of the NIH-defined Early Stage Investigator classification period. This policy takes into consideration factors that may contribute to new investigators experiencing a lapse in their research or research training, or experiencing periods of less than full-time effort, during the 10-year ESI period.
Dr. Salim Yusuf, Director of Population Health Research Institute at McMaster University and Hamilton Health Sciences in Hamilton, Canada, shared his insights on global health and chronic diseases. Dr. Yusuf is a renowned cardiologist and epidemiologist, whose interests include evaluation of therapies and population health in developed and developing countries. Dr. Yusuf posited the factors he believes have led to a global increase in cardiovascular disease—the decrease in childhood and infectious diseases, resulting in people living longer; increased tobacco use; and urbanization, with its accompanying decreases in physical activity and increases in energy consumption, fat consumption, and psychosocial stress.
Dr. Yusuf led the INTERHEART study, one of the largest (involving 52 countries) case-controlled studies of acute myocardial infarction (acute MI). INTERHEART found that nine simple risk factors account for 90 percent of the risk of acute MI—ApoB/ApoA-1 (a measure of lipids), smoking, diabetes, hypertension, abdominal obesity, psychosocial factors, daily fruit and vegetable consumption, exercise, and alcohol use. Dr. Yusuf is currently leading the Prospective Urban Rural Epidemiologic (PURE) Study, an international study of factors that contribute to several major diseases, including cardiovascular disease, diabetes, obesity, obstructive airways disease, and renal disease.
Dr. Yusuf shared his vision for the future of epidemiologic investigation in cardiovascular disease, which entails understanding the causes of cardiovascular risk factors (both societal factors and gene-environment and gene-gene interactions), a life course approach to cardiovascular disease prevention, and implementing what we already know. In his opinion, large reductions in cardiovascular disease are possible within two decades.
Dr. Michael S. Lauer, Director of the Division of Prevention and Population Sciences, NHLBI, discussed the NIH role in comparative effectiveness research (CER). As defined by the Congressional Budget Office, CER is "... a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients." CER "may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy. The analysis may focus only on the relative medical benefits and risks of each option, or it may also weigh both the costs and the benefits of those options."
CER is prominent in the current national political debate, as policy makers recognize the serious implications of rapidly rising health care costs and the fact that higher costs do not always lead to better health outcomes. Funding for CER has been proposed as part of the Economic Recovery legislation.
The NIH has extensive experience in initiating, directing, and supporting CER studies, many of which have improved public health and clinical care. Examples of NHLBI-supported CER include the Coronary Artery Surgery Study (CASS), Cardiac Arrhythmia Suppression Trial (CAST), Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT), Sudden Cardiac Death Heart Failure Trial (ScD-HeFT), National Emphysema Treatment Trial (NETT), Systolic Blood Pressure Intervention Trial (SPRINT), and Cardiovascular Research Network (CVRN). Dr. Lauer concluded that the NIH should promote its interest in CER and its strong capabilities to move CER forward.
Dr. Mockrin summarized the status of key recommendations in each of four priority areas.
- Engage the Best Reviewers: The NIH is taking steps toward improving reviewer retention, recruiting the best reviewers, enhancing reviewer training, and allowing flexibility through virtual reviews.
- Improve the Quality and Transparency of Review: The NIH is instituting a 9-point scoring system, criteria-based scoring, enhanced review criteria, formatted reviewer critiques, and structured summary statements. Reviewers will assign each application an overall impact/priority score, which will be independent of criteria scoring and reflective of the project's likelihood to exert a sustained, powerful influence on the research field involved.
- Ensure Balanced and Fair Reviews across Scientific Fields and Career Stages: The NIH is enhancing success rates of new and resubmitted applications by decreasing the number of allowed resubmissions (i.e., amendments) from two to one. The NIH is also taking steps toward reviewing like applications together.
- ontinuous Review of Peer Review: The NIH has constituted an evaluation group to develop the foundation for continuous review of the peer review process.
The Enhancing Peer Review Web Site is continually updated with information, implementation timelines, NIH Guide Notices, and other materials.
Ms. Victoria Pemberton, Clinical Trials Specialist in the Division of Cardiovascular Diseases (DCVD), NHLBI, demonstrated a new NHLBI Web site entitled Children and Clinical Studies that offers facts and insights to help families make informed decisions about whether to enroll their children in a clinical study. Launched in October 2008, the Web site combines information about how clinical studies are conducted among the young with an award-winning video of children, parents, and healthcare providers discussing the rewards and challenges of participating in research.
Dr. Gail Pearson, Medical Officer in the DCVD, NHLBI, announced that the main 10-minute video featured on the Web site has earned three Telly awards, including a silver (the highest award) in education, which she presented to Dr. Nabel. The prestigious Telly awards honor outstanding local, regional, and cable TV commercials and programs; film and video productions; and Web ads, videos, and films.
Dr. Carl Roth, Associate Director for Scientific Program Operation, NHLBI, presented the Institute's biennial report on its procedures for, and results of, implementing the NIH policy for inclusion of women and minorities in clinical studies. The biennial report is mandated by the NIH Revitalization Act of 1993. NHLBI procedures require that Program Officers evaluate relevant projects for appropriate representation of women and minorities; discuss concerns with senior staff; discuss concerns and possible solutions with applicants; and release a project for Council consideration once all issues have been resolved.
Dr. Roth presented target and enrollment data, by race/ethnicity and by sex, for the Institute's clinical studies active in FY 2007 (the most recent data available). For each minority group, the targeted percentages exceeded the corresponding representation in the 2000 U.S. Census. The enrollee distribution was very close to its targeted percentages. FY 2007 is the first year since the Institute started collecting these data that the percentage of Hispanics participating in NHLBI clinical studies exceeded their representation in the U.S. Census.
The Council found the Institute to be in compliance.
Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, thereby adding flexibility and decreasing the burden on the Council. Dr. Mockrin reported that in FY 2008, the Institute undertook 74 actions (totaling $11,368,463) using its delegated authorities. The Council accepted the report.
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 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).
The Council considered 1,073 applications requesting $1,290,083,189 in total direct costs. The Council recommended 1,072 applications with total direct costs of $1,288,690,339. A summary of applications by activity code may be found in Attachment B.
The meeting was adjourned at 3:30 p.m. on February 10, 2009.