NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
February 14, 2007

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

Dr. Elizabeth G. Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 225th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). Several Council members and NHLBI staff participated by telephone due to hazardous weather conditions.

Member Updates:

Dr. Nabel announced the selection of six new Council members:

  • Shaun Coughlin, M.D., Ph.D., Director, Cardiovascular Research Institute, University of California, San Francisco
  • Joe Garcia, M.D., Professor and Chair, Department of Medicine, University of Chicago
  • Rao Musunuru, M.D., President of Bayonet Point/Hudson Cardiology Associates, Hudson, Florida
  • Jeanine Arden Ornt, J.D., Vice President and General Counsel, Case Western Reserve University
  • Paula Polite, Manager of Quality Programs for the City of Memphis, Tennessee; and Founder and Past President of the Sarcoidosis Research Institute
  • Steven Shapiro, M.D., Jack D. Myers Professor and Chair, Department of Medicine, University of Pittsburgh

Invited Guest:

Dr. Nabel introduced F. Daniel Armstrong, Ph.D., of the Miller School of Medicine at the University of Miami, the Sickle Cell Disease Advisory Committee.

New Staff:

Dr. Nabel announced that Michael S. Lauer, M.D., has been tentatively selected for the position of Director of the Institute's Division of Prevention and Population Sciences and his appointment is pending the appropriate approvals . Dr. Lauer is currently Director of the Cleveland Clinic Foundation Exercise Laboratory, Vice-Chair of the Clinic's Institutional Review Board, and a Contributing Editor of the Journal of the American Medical Association. As a leader in the cardiovascular community, Dr. Lauer has an exceptionally strong background in cardiovascular epidemiology and medical research.

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II. REVIEW OF CONFIDENTIALITY AND 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. REPORT OF THE DIRECTOR - Dr. Elizabeth G. Nabel

Dr. Nabel reported that the newly designated Center for the Application of Research Discoveries (CARD), formerly the Office of Prevention, Education, and Control (OPEC), will initiate new knowledge networks, education programs, community outreach activities, and conferences to help narrow the gap from scientific discovery to application of findings. Under the continuing direction of Dr. Gregory Morosco, the CARD will continue to reach out to high-risk, low income, and minority communities.

Budget Update:

Dr. Nabel reviewed the Institute's budget for the FY 2007 Joint Resolution, which provides $2,918,808 for the Institute. Dr. Nabel noted that budgetary times remain extremely tight. The FY 2008 President's Budget contains $2,925,413 for the Institute, an increase of only $6.6 million (0.23 percent) over the FY  2007 Joint Resolution. Despite the tight budget, the Institute plans to increase its number of competing research project grants by 10 percent in FY 2008, by compensating modestly in other areas. The Institute continues to maintain its commitment to investigator-initiated research during this austere period.

Based on the fiscal policy that Dr. Zerhouni proposed and the agreed upon fiscal policy that was developed in consultation with all of the institutes and centers across the NIH, Dr. Nabel reviewed several priorities in 2007.

  1. Keep the investigator initiated grants (R01s or RPGs) as robust as possible - try to augment those dollars to keep the pay lines as generous as possible.
  2. Target new investigators – the NHLBI has had a policy for first-time R01 applicants since 2005 that has served the community well.
  3. Help first-time R01 recipients who apply for a first competitive renewal.
  4. Support training.
  5. Support established investigators who might have a single R01 and are at risk of losing their laboratory, if their competitive renewal is not funded.

Dr. Nabel indicated that when the continuing resolution is passed, she will give the council members with an update on the NHLBI budget.

Initiatives:

The Institute recently initiated two national educational campaigns:

  • Stay in Circulation: Take Steps to Learn about PAD. seeks to raise awareness among those at risk for peripheral arterial disease (PAD). The campaign encourages those over 50 to talk to their doctors about their risks and to ask about a simple test called the ankle brachial index (ABI).
  • COPD: Learn More, Breathe Better seeks to improve awareness among those at greatest risk for chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S. The Institute's COPD research program and the education campaign were discussed in more detail later in the meeting.

Other Announcements:

The Heart Truth campaign continues to flourish by increasing the population that receives messages and promotion of the Red Dress as the national symbol for women and heart disease. Newly analyzed data show progress—women who die from heart disease decreased by 17,000 heart disease deaths from 2003 to 2004 .

The proposed trans-NIH policy for genome-wide association studies (GWAS) is being reviewed following opportunities for public comment and is in the process of being finalized.

NHLBI Report on Inclusion of Women and Minorities in Clinical Research

The Institute reports to Council biennially on its procedures for, and results of, implementation of the NIH policy for inclusion of women and minorities in clinical studies. The Institute's current report, which presents participation data for clinical studies active in FY 2005, was distributed to Council. The Institute will assume Council agrees it is in compliance unless notified otherwise by February 21.

Annual Review of Council Delegated Authority

Dr. Nabel asked the Council to review the revised "Delegated Authorities from the National Heart, Lung, and Blood Advisory Council," with special attention to an additional delegated authority proposed to permit the Institute to make certain administrative decisions regarding the selection and funding of competing grant applications in the event of a federally declared emergency. Council approved the delegated authorities.

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IV. NHLBI STRATEGIC PLAN Dr. Elizabeth G. Nabel

Dr. Nabel presented the final draft of the NHLBI Strategic Plan, the result of an intensive 18-month community-wide effort to develop a scientific blueprint for the next 5 to 10 years. She reviewed the Institute's strategic planning process and discussed the major substantive components of the draft plan.

The first step of the planning process comprised 23 thematic working groups held April – August of 2006 (that incorporated input from over 500 investigators) to identify scientific areas where the Institute is well positioned to make major contributions. The Institute also convened a planning conference in September 2006 to explore the development of a national knowledge network to explore ways to narrow the gaps between research discovery and application. In October 2006, a meeting brought together members of the Council, chairpersons of the previous meetings, and other thought leaders to develop Institute-wide strategic themes. The resulting draft strategic plan was made available on the NHLBI Strategic Plan Website for public comment from January 3 – February 1, 2007.

The draft strategic plan is organized around three Goals:

  • Improve understanding of the molecular and physiologic basis of health and disease, and use that understanding to develop improved approaches to disease prevention, diagnosis, and treatment.
  • Improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment.
  • Generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery.

Each Goal is defined further by scientific Challenges, and eight strategies were developed to address the Challenges.

The Council expressed much enthusiasm for the plan and approved it with a few suggested revisions.

Dissemination of the plan will begin in the Spring of 2007 and be accessible on the Strategic Plan Website at: http://apps.nhlbi.nih.gov/strategicplan/. In June, the website will offer an illustrated version of the plan for scientific audiences, an illustrated summary brochure suitable for patients and the general public, and a PowerPoint presentation covering the planning process and contents of the plan.

Dr. Nabel requested that the Council take the lead in advising the Institute on setting priorities and implementing the plan, evaluating progress, and identifying future adjustments. She announced that a new working group of the Council—the Board of External Experts (BEE)—will be a resource for innovative ideas, and will evaluate and prioritize initiatives and assess implementation of the strategic plan prior to Council's review. The first BEE meeting will be held on June 1, 2007, to consider initiatives for FY 2008.

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V. PUBLIC INTEREST ORGANIZATION (PIO) MEETING Ms. Paula Polite

The NHLBI hosted its eighth annual PIO Meeting in Bethesda, Maryland, on February 12-13, 2007. The meetings have been designed to foster collaborations and encourage the sharing of best practices among PIOs, as well as encourage communication between PIOs and the NHLBI.

Ms. Paula Polite, Founder and Past President of the Sarcoidosis Research Institute, reported on the meeting from a participant's perspective. On behalf of all the PIOs, she thanked the Institute for its sustained concern and compassion for their patients. She emphasized that the meetings are a source of synergy for the organizations. Participants continue to find the scientific sessions interesting and the meetings with NHLBI staff very helpful, and they continue to learn from each other, through formal presentations made by PIO representatives as well as from informal networking.

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VI. NHLBI TRAINING GRANTS: FUNDING OPTIONS AND RECOMMENDATIONS Dr. Carl Roth

Dr. Carl Roth, Associate Director for Scientific Program Operation, NHLBI, presented the recommendations of an NHLBI working group charged with reviewing the Institute's training grant program (T32 mechanism) and developing strategies to ensure the continued advance of new knowledge and research training competencies to address heart, lung, and blood diseases and conditions. Two challenges were addressed:

  • Timing of awards: The current timing of awards (July award dates) results in critical program disruptions if renewal applications are not funded and poses difficulties for training programs to attract high caliber candidates because positions cannot be offered until July.

    Recommendations: Establish new receipt dates for FY 2008 to allow better timing for resubmissions and earlier awards (February/March) to allow earlier trainee commitments.

  • Fiscal constraints: The size of T32 competing renewals limits the Institute's ability to support new programs; meritorious applications cannot be funded.

    Recommendations: Apply a specified strategy for reducing Full-Time Training Positions (FTTPs) for competing T32 applications in FY 2007; take additional steps in FY 2008 to limit FTTPs for all T32 awards (competing and noncompeting) and target 15-20 percent of T32 funding to new awards; and discontinue acceptance of second amendments (A2 applications) for competing renewals in FY 2009.

The Council enthusiastically accepted the proposed changes.

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VII. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) RESEARCH AND EDUCATION PROGRAM Dr. Thomas Croxton and Ms. Amy Pianalto

Dr. Thomas Croxton, Program Director, Airway Biology and Disease Branch, Division of Lung Diseases, NHLBI, described the complexity of COPD, summarized the Institute's COPD research program, and highlighted strategic opportunities in COPD research and education. COPD is a serious public health problem—affecting 24 million people in the U.S. today and causing over 120,000 deaths per year. The NHLBI has initiated a number of research programs that address COPD at all levels (molecule, cell, system, person, and population).

Ms. Amy Pianalto, Project Director, Center for the Application of Research Discoveries, NHLBI, described the recently launched national campaign, COPD: Learn More, Breathe Better, developed by the NHLBI to increase awareness and understanding of COPD and its risk factors and to emphasize the benefits of early detection and treatment. In partnership with leading professional societies, health organizations, and advocacy groups, the campaign reaches out to at-risk adults (smokers and former smokers ages 45 and older), diagnosed COPD patients and their caregivers, and health care providers. Numerous resources—public service announcements, fact sheets, a Web site, www.nhlbi.nih.gov/health/public/lung/copd, an educational video and poster, and materials for community-level organizations—will support the campaign.

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VIII. CLOSED PORTION

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 session included 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.

REVIEW OF APPLICATIONS

The Council considered 1,181 applications requesting $339,487,546 in total direct costs. The Council recommended 1,179 applications with total direct costs of $338,987,546. A summary of applications by activity code may be found in Attachment B.  

ADJOURNMENT

The meeting was adjourned at 2:30 p.m. on February 14, 2007.

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