NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
June 16, 2005

I. CALL TO ORDER AND OPENING REMARKS - Dr. Elizabeth G. Nabel

Dr. Elizabeth G. Nabel, Director of the National, Heart, Lung, and Blood Institute opened the meeting and welcomed the Council members to the 218th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Guests

Dr. Nabel welcomed Dr. Gary Gibbons, Director of the Cardiovascular Research Institute and Professor of Medicine at the Morehouse School of Medicine, who is a member of the NHLBI Board of Extramural Advisors (BEA), a working group of the National Advisory Council. Dr. Gibbons attended Council to provide some BEA perspective during the Council discussions of the BEA initiatives.

Member Updates

Dr. George Thomas was unable to attend the meeting.

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II. REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST - Dr. Elizabeth G. Nabel

The Council was reminded that according to Public Law 92-463, the Federal Advisory Committee Act, the meeting of the NHLBAC would be open to the public except during consideration of grant applications. A notice of this meeting was published in the Federal Register indicating that it would start at 8:30 a.m. and remain open until approximately 12:00 p.m. Dr. Nabel also reminded the Council members that they are special government employees and are subject to departmental conduct regulations.

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III. DIRECTOR’S REPORT - Dr. Elizabeth G. Nabel

Dr. Nabel has begun a series of journal editorials in order to enhance communication between the Institute and its constituency groups, grantees, and public advocacy groups. The first editorial is entitled “A Vision for the Future of the NHLBI,” and will be published in early July in four journals: The American Journal of Respiratory and Critical Care Medicine, Blood, Circulation, and Sleep. Dr. Nabel plans to write four editorials a year that will cover timely topics that are of concern to NHLBI constituencies. Dr. Nabel welcomes comments on her editorials from members of the Council.

Dr. Nabel highlighted a national education program called “ We Can!” (Ways to Enhance Children’s Activity & Nutrition) to help prevent overweight and obesity among children ages 8-13, which was launched June 1st. Developed by the NHLBI and promoted in collaboration with three other NIH Institutes (National Institute of Diabetes and Kidney Diseases, National Institute of Child Health and Human Development, and the National Cancer Institute) as well as several national private organizations, “ We Can!” provides resources and community-based programs for parents, caregivers, and youth that focus on behaviors to encourage healthy eating, increase physical activity, and reduce sedentary time. The program is based on findings of several studies, including a recently-reported ancillary study of the NHLBI-supported Dietary Intervention Study in Children (DISC). The program was developed at NHLBI through the Office of Prevention, Education and Control. Secretary Leavitt’s press release was provided in the Council briefing books. Dr. Nabel and Dr. Zerhouni, Director of NIH, went on television and radio to broadcast the “We Can” program throughout the country. More than 35 communities across the nation have already agreed to implement “ We Can!”programs. The NHLBI will be seeking more partners in a variety of community settings to use and distribute program materials in an effort to address childhood obesity which is a serious public health problem in this country.

NHLBI will host a Thought Leaders’ meeting on June 17, 2005 and Dr. Nabel explained that the meeting was organized by the Office of Prevention, Education and Control to look at strategies involving cardiovascular education and dissemination programs. NHLBI has programs for hypertension and cholesterol education which have had major impact on public health in this country. Dr. Dan Jones, who is the Dean at the University of Mississippi Medical School has been involved with these programs for many years and is the co-chair of the meeting along with Dr. Nabel. Council members were invited to attend.

Management Status

Dr. Nabel announced that Dr. Barbara Alving resigned as Deputy Director to become Acting Director of the National Center for Research Resources (NCRR), while still maintaining her position as Director of the Women’s Health Initiative (WHI). Dr. Carl Roth is currently serving as Acting Deputy Director in addition to his regular duties as Associate Director of Scientific Program Operation. The Institute is currently seeking applicants for the Deputy Director position as well as for the Special Assistant for Clinical Research which was previously held by Dr. Lawrence Friedman . This position entails responsibility for oversight of all aspects of Institute-supported clinical research, including oversight of data and safety monitoring recommendations, monitoring of adverse event reporting, and review of conflicts of interest. Both position announcements will close on September 1, 2005.

Dr. Nabel has formed a Task Force on New Investigators to address issues surrounding the support of new investigators in the current and future budget climates. Dr. Helena Mishoe who chairs the NHLBI Training Committee is heading the Task Force and will make recommendations for short and long term policy changes to prevent the loss of new physician scientists in the country.

Dr. Nabel informed the Council that the U.S. House of Representatives Committee on Energy and Commerce has recently expressed interest in reauthorization legislation for the NIH. Fully authorized under the Public Health Service Act, the NIH has been operating for several years without additional authorization. Dr. Nabel mentioned three issues currently under discussion for inclusion in a reauthorization bill: development of an enhanced system for reporting to Congress; increased authority of the Director, NIH, to tap the budgets of Institutes/Centers (ICs) for trans-NIH activities; and clustering of ICs and IC budgets.

In addition, Dr. Nabel described an ongoing effort by the Office of the Director, NIH, to address liability coverage for Data Safety Monitoring Boards involved with reviewing clinical studies. This is currently a critical issue for institutions which must bear the costs of the coverage. Dr. Zerhouni, Director of NIH, has established a Working Group which makes recommendations and plans for implementation.

Budget Report

Dr. Nabel reviewed the recent budget history of the Institute, noting the austere financial times currently faced by the NIH. The proposed FY 2006 President’s Budget for the NHLBI is $2,951.3 million, a 0.3 percent increase over the Institute’s FY 2005 appropriation. The current NHLBI pay line for research project grants is at the 19.0 percentile (24.0 percentile for new investigators—see section "Fostering the Independence of New Investigators" below), considerably below the pay lines of recent years, which have ranged from a high at the 35.0 percentile in FY 2001 to the 25.0 percentile in FY 2004. Dr. Nabel noted, however, that the current NHLBI pay line is one of the highest among the NIH Institutes and Centers and that the NHLBI has also been able to avoid cutting award amounts to investigators in the noncompeting years of their grants. She attributed this budgetary success to the Institute's outstanding planning, led by the NHLBI Budget Office and the Institute’s recent past Director and Acting Director. However, Dr. Nabel emphasized the Institute’s priority to fund as many research project grants as possible.

Dr. Nabel alerted Council to several changes in future meeting dates of the Council. The dates have been changed to accommodate the Institute Director meetings which occur on Thursdays.

Publications

The following items and publications were provided:

• copy of the Annual Report of the Trans-NIH Sleep Research Coordinating Committee for fiscal year 2004.
• materials for the “We Can” Program (Ways to Enhance Children’s Activity & Nutrition).

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IV. CENTERS OF EXCELLENCE – Dr. Elizabeth G. Nabel

Dr. Nabel initiated discussion about the potential for establishing NHLBI Centers of Excellence in heart, lung, blood, and sleep disorders. To provide background for discussion, Dr. James Kiley, Director, Division of Lung Diseases, NHLBI, reviewed the Institute’s approach to clinical research, emphasizing the benefits realized from three successful Institute-supported programs: Clinical Research Networks; and Specialized Centers of Research (SCOR) and Specialized Centers of Clinically Oriented Research (SCCOR) programs. Since 1993, the Institute has supported 12 clinical research networks in a variety of heart, lung, and blood disease areas. The Institute currently supports (or plans to initiate support of) 17 SCOR/SCCOR programs.

Dr. Nabel described briefly the Comprehensive Cancer Centers, supported by the National Cancer Institute (NCI), which conduct programs in basic research, clinical studies, and prevention and control research, as well as community outreach and education. The Centers serve as intellectual homes for investigators, and their resources are leveraged with additional resources from academic health centers, universities, communities, states, and philanthropies.

Several issues related to establishing a Centers program are: how to ensure effective leveraging of our investment with contributions from other organizations; how to organize Centers around different types of activities, multiple NHLBI programmatic areas (i.e., heart, lung, blood, sleep), and various scientific themes; what types of activities to support within the general categories of infrastructure, training, and research; whether to require Centers to participate in other NHLBI programs, such as networks or SCCORs; and whether (and how) a Center’s program should be designed to support high risk, innovative research.

Council members were supportive of the Centers concept. They emphasized the need for flexibility in what is funded (Centers, SCORs/SCCORs, Networks) and to ensure that our investment in Centers would be leveraged by additional resources from other organizations and that accountability would be maintained. Several members were supportive of SCORs/SCCORs which allow innovative clinical research as well as networks which allow for research on more mature therapies. Further suggestions from Council members are welcome.

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V. FOSTERING THE INDEPENDENCE OF NEW INVESTIGATORS – DR. HELENE MISHOE

The NHLBI Task Force on Fostering the Independence of New Investigators was established to identify strategies to facilitate the ability of investigators to receive a first independent research award earlier in their careers. Dr. Helena Mishoe, Director of the NHLBI Office of Minority Health Affairs and Co-Chair of the Task Force, discussed current NHLBI practices to foster independence of new investigators, including an NHLBI New Investigator Web page, an increase in the percentile pay line for meritorious applications from new investigators (currently a 5 percentile point increase), and help for applicants for "K" series (Career Development) awards. Dr. Mishoe also described potential future strategies, including working with the NIH to strengthen NRSA training programs by requiring lab/project management training and grant writing instruction; and establishing an expedited Council review of communications addressing IRG concerns submitted by new investigators whose applications are within 5 percentile points of the new investigator pay line, thereby decreasing the time required for resubmitting amended applications and subsequent review.

Dr. Nabel emphasized that the Institute is looking at both short-term and long-term approaches to helping new investigators, as well as contributing toward NIH-wide approaches.

Council members were supportive of these efforts and commented on difficulties that applications from new investigators encounter in review. However, the criteria for new investigators are designed to mitigate against these difficulties and efforts are underway to try apply them uniformly in all study sections.

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VI. BOARD OF EXTRAMURAL ADVISORS WORKING GROUP: INITIATIVES FOR FISCAL YEARS 2006/2007- Dr. Elizabeth G. Nabel and Dr. Charles Peterson

NHLBI staff presented 10 new initiatives, all of which were reviewed in April by the Board of Extramural Advisors (BEA). Dr. Charles Peterson, Director, Division of Blood Diseases and Resources, explained that the BEA functions as a Working Group of the Council, and that all initiatives presented to the BEA are subsequently reviewed and discussed by the Council. Dr. Gary H. Gibbons, BEA member and Director of the Cardiovascular Research Institute and Professor of Medicine at the Morehouse School of Medicine, augmented the Council discussion by providing the BEA's perspective where helpful.

The Council was supportive of all the initiatives but made a number of specific recommendations for consideration prior to their release. Dr. Nabel will consider the recommendations of the BEA and the Council and other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement. NHLBI staff also presented 3 initiatives which were not ranked by the BEA.

Objective: To foster a coordinated systems biology approach to understanding normal physiology and the perturbations associated with heart, lung, blood, and sleep disorders. (A systems biology approach uses the combination of experimental data and mathematical models to understand and predict function and behavior of complex biological systems.)

Objective: To determine the efficacy of long-term oxygen treatment for improving survival in patients with chronic obstructive pulmonary disease (COPD) and less-than-severe hypoxemia at rest (by conducting a randomized, unblinded clinical trial in patients with evidence of systemic disease, such as severe dyspnea, reduced exercise capability, or low body mass index).

3. Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine (RFA)

Objective: To evaluate new surgical techniques, technologies, devices, and bioengineered products by conducting rigorous Phase I and Phase II clinical trials.

4. Clinical Hematology Research Career Development Program (RFA)

Objective: To develop and evaluate multidisciplinary career development programs in clinical hematology research that will equip new academic researchers with the knowledge and skills to address complex problems in blood diseases, transfusion medicine, and cellular therapies.

5. Clinical Interventions for Weight Loss in Obese Adults with Cardiovascular Risk Factors (RFA)

Objective: To test the effectiveness of interventions delivered in routine clinical practice for achieving weight loss in obese patients who have other cardiovascular risk factors.

6. Diagnosis and Therapy Development for Von Willebrand Disease (RFA)

Objective: To develop improved diagnostic tools, identify genetic and environmental modifiers, design new therapeutic options, and evaluate the safety and effectiveness of treatment regimens for Von Willebrand Disease.

7. Mechanisms Linking Short Sleep Duration and Risk of Obesity or Overweight (RFA)

Objective: To elucidate cause-and-effect relationships and mechanisms to explain associations between short sleep duration and increased risk of obesity or overweight.

8. Cellular and Molecular Mechanisms of Aortic Valve Sclerosis and Stenosis (RFA)

Objective: To elucidate the biology of aortic valve sclerosis, emphasizing its initiation and progression to aortic stenosis, and to encourage the development of relevant animal models.

9. Adult Congenital Heart Disease Registry (RFA or RFP)

Objective: To identify adults with congenital heart disease and develop a database (for use in hypothesis-driven research) containing detailed clinical characterizations of the identified patients.

10. SNP-based Linkage Genotyping Service (RFP)

Objective: To create a new genotyping service that will perform single nucleotide polymorphism (SNP)-based genome-wide linkage in a cost-effective, high-throughput, and highly reproducible manner for investigators performing human genetics research and clinical studies related to the mission of the NHLBI.

The following initiatives were brought to the BEA but not ranked.

1. Alpha-CVD Trial: Effect of Alpha-Linolenic Fatty Acid on Cardiovascular Disease (RFP)

Objective: To determine whether dietary supplements of alpha-linolenic acid (ALA), a plant source of omega-3 fatty acids, prevent cardiovascular deaths when added to standard therapy in adults with clinical cardiovascular disease.

2. Atherosclerosis Prevention Trial (RFP)

Objective: To determine whether maximal reduction of low density lipoprotein (LDL) cholesterol reduces major adverse cardiovascular events in patients with elevated risk but without known coronary disease.

3. Cardiovascular Cell Therapy Clinical Research Network (RFA)

Objective: To establish a network capable of providing a stable infrastructure for conducting safe, efficient Phase I and Phase II cell therapy clinical protocols, with the goal of facilitating clinical implementation of cell-based therapies for cardiovascular disease.

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VII. CLOSED PORTION

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

There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

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VIII. REVIEW OF APPLICATIONS

The Council considered 1,214 applications requesting $1,713,563,173 in total direct costs. The Council recommended 1,214 applications with total direct costs of $1,689,414,863. A summary of applications by activity code may be found in Attachment B.

ADJOURNMENT

The meeting was adjourned at 3:30 p.m. on June 16, 2005.

 CERTIFICATION

I hereby certify that the foregoing minutes are accurate and complete.

_________________

Elizabeth G. Nabel, M.D. Date

Chairperson

National Heart, Lung, and Blood Advisory Council

_________________

Deborah Beebe, Ph.D. Date

Executive Secretary

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