NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
February 12, 2004

I.    CALL TO ORDER AND OPENING REMARKS - Dr. Barbara Alving

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Dr. Barbara Alving, Acting Director of the National, Heart, Lung, and Blood Institute opened the meeting and welcomed the Council members to the 213th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).  Dr. Alving announced that February is National Heart Month and that there would be a presentation of the Heart Truth Campaign at the meeting.

Management Status:

The search for the Institute Director closed on Friday February 6, 2004.  It is expected that a new Director of NHLBI will be appointed by summer 2004.

Member Updates:

The new members attending the meeting were:

  • Dr. Roberto Bolli, Chief of the Division of Cardiology at the University of Louisville.

  • Dr. Richard Boucher, Director of the Cystic Fibrosis/Pulmonary Research and Treatment Center at the University of North Carolina-Chapel Hill
  • Ms. Mary Deer, Program Coordinator at the National Indian Women’s health Resource Center
  • Dr. Robert Lemanske, Professor of Medicine and Pediatrics at the University of Wisconsin
  • Dr. George Thomas could not attend the meeting.

Guests:

  • Attendees from the Public Interest Organization Meeting which was held on February 11, 2004.
Guest Speakers:
  • Dr. William Baumgartner, Cardiac Surgeon-in-Charge of Johns Hopkins Cardiac Surgery at the Johns Hopkins Hospital.
  • Dr. Milton Packer, Chief of Circulatory Physiology in the Department of Medicine at the Columbia Presbyterian Medical Center.

New Publications:

  • Heart Truth core brochures and the Red Dress pin
  • Heart Truth for Women fact sheets for African-American and Latino Women in English and Spanish
  • FYI from the NHLBI
  • NHLBI Fact Book for Fiscal Year 2003

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II.    REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST - Dr. Barbara Alving

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. Alving 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 ACTING DIRECTOR - Dr. Barbara Alving

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Budget-Ms Sandra Gault, Budget Officer

Ms. Sandra Gault, Chief, Financial Management Branch, NHLBI, gave an overview of the President's FY 2005 budget request for the NHLBI, which totals $2,964.0 million, a 3.0 percent increase over last year. Funding for research centers is expected to increase by 7.6% in FY 2005, which reflects the increase in the clinical components of its center grants.

Update on the Heart Truth Campaign - Ms Terry Long

The Heart Truth is a national awareness campaign for women about heart disease. Ms. Terry Long, Senior Manager for Health Communications and Information Science, Office of Prevention, Education, and Control, NHLBI, described the momentum that has been generated by The Heart Truth campaign since it began in September 2002. Directed primarily at women 40-60 years of age, the campaign seeks to increase awareness that heart disease is the number one cause of death for women and to educate women about its risk factors. The Heart Truth is being conducted in partnership with the American Heart Association, the Office of Women’s Health of the U.S. Department of Health and Human Services, Women Heart—the National Coalition for Women with Heart Disease, and other organizations committed to the health and well-being of women. The centerpiece of the campaign is the “red dress” which is the national symbol for women and heart disease awareness. Over the past year, the red dress and the campaign it symbolizes have received much attention in the media (including Time, Glamour, Newsweek, and major national newspapers), engaged the participation of First Lady Laura Bush, and captured the attention of the fashion industry. Numerous educational materials are available from the campaign website at http://www.hearttruth.gov.

February 2004 has been a busy month with: 
  • Continued involvement of First Lady Laura Bush.
  • Debut of the Red Dress Collection 2004 at New York City.
  • Launch of The Heart Truth Road Show, which is taking heart healthy messages to five major cities.

Ms. Long closed her presentation with a video clip of the fashion show of red dresses featured at Olympus Fashion Week a few days before.

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IV.    CARDIOTHORACIC SURGERY - Dr. William Baumgartner and Dr. Alice Mascette

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Dr. William Baumgartner, Cardiac Surgeon-in-Charge, The Johns Hopkins Hospital, presented an overview of cardiothoracic surgery entitled "Cardiothoracic Surgery: Measuring Success from the Past and into the Future".  The definition of Cardiothoracic Surgery is thoracic surgery encompassing the operative, preoperative, and surgical critical care of patients with acquired and congenital pathological conditions within the chest. He reviewed the history of cardiac surgery and summarized the findings of important clinical trials involving cardiac surgery.  He described the development, content, and management of the Society of Thoracic Surgeons (STS) database and explained the role of the database in promoting continuous quality improvement (CQI).

Dr. Baumgartner also noted: the advances in congenital heart surgery the changing pattern of cardiac surgical diseases the emerging role of robotic techniques in cardiothoracic surgery the areas for future clinical investigation Council discussed the need for comprehensive cardiovascular centers within academic institutions to co-locate catheter labs with radiology and surgical departments.  Council noted other issues including cardio protection and stenosis of grafts. Dr. Alice Mascette, Director, Clinical and Molecular Medicine Program, Division of Heart and Vascular Diseases, NHLBI, described current and planned NHLBI activities in cardiothoracic surgery and summarized the Institute's main accomplishments. In general surgical research has shown a mortality benefit from surgical revascularization in defined populations, refined and advanced revascularization procedures, developed devices for the failing heart, established heart transplantation as “usual care” and extended advancements to the pediatric population.  The Institute is pursuing new directions in cardiovascular cell-based therapies, innovative tissue engineering, and Vascular Endothelial Growth Factor (VEGF)  Gene Therapy.  There will be a Workshop on Future Directions in Cardiac Surgery in May 2004.

Council discussed the difficulty of initiating and conducting a trial before new and innovative procedures become popularized and widely used.

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V.    REPORT ON THE WORKING GROUP ON STRATEGIC DIRECTIONS FOR CONGESTIVE HEART FAILURE - Dr. Milton Packer and Dr. John Fakunding

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Dr. Milton Packer, Chief of Circulatory Physiology in the Department of Medicine, Columbia-Presbyterian Medical Center, summarized the report of the Working Group on congestive heart failure (CHF) which he chaired.  The Working Group was convened in July 2003 to address future research directions in CHF which is a major ublic health problem in the United States. Approximately five million individuals are diagnosed with heart failure and eighty percent of men and seventy percent of women who have CHF will die within eight years.  The economic costs are estimated to exceed $23 billion.

The report focused on five areas:

  • heart failure with preserved systolic function
  • genetics/genomics of heart failure
  • drug treatment
  • treatment with transplantation or devices
  • biomarkers and proteomics applied to heart failure

The Working Group made the following recommendations to guide the NHLBI in planning its research agenda:

  • Consider a clinical trial in patients with heart failure comparing different diuretic strategies.
  • Create investigative teams or consortia, such as clinical research networks, with access to CHF patients to investigate new approaches to the characterization, management, and treatment of patients with this disease.
  • Develop a multidisciplinary approach to understanding the cardio-renal interactions in heart failure.
  • Conduct clinical studies to define the underlying path physiology in heart failure patients with preserved left ventricular function.
  • Conduct a trial of aldosterone blockade in patients with heart failure with preserved systolic function.
  • Support the standardized collection of samples from patients in clinical trials or population-based studies for genomic/genetic, proteomic, or expression array analysis.
  • Develop appropriate studies to enable the design of clinical trials to assess treatments for asymptomatic individuals with left ventricular dysfunction.
  • Develop strategies for the management of individuals in end-stage heart failure.

Dr. John Fakunding, Director, Heart Research Program, Division of Heart and Vascular Diseases, NHLBI, summarized NHLBI-supported research in heart failure and indicated that NHLBI will address the recommendations of the Working Group.

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VI.    REPORT ON THE PUBLIC INTEREST ORGANIZATION (PIO) MEETING - Ms. Sue Byrnes

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The fifth annual NHLBI-sponsored meeting was held in Bethesda, Maryland, on February 11, 2004. PIO representatives were invited to attend the open session of the Council meeting. Ms. Sue Byrnes, Executive Director of the LAM Foundation and currently serving on the NHLBAC, reported that the meeting was a huge success.  She praised the meeting for being well-organized and noted the significant increase in attendance.  In general the meeting encourages the development of new leaders and provides opportunities to share and discover new resources. Ms. Byrnes noted the remarkable synergy among the participants which was inspiring.  In addition Mr. Carl Wexler representing the Hemophilia Federation of America expressed his appreciation to the NHLBI, on behalf of all the PIOs, for holding these worthwhile meetings each year.

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VII.    INITIATIVES FOR FISCAL YEARS 2006/2007 - Dr. James Kiley

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In 2001 the NHLBAC recommended that the Institute modify its existing Specialized Centers of Research (SCOR) program to place greater emphasis on clinical research. As a result, the Institute implemented a new Specialized Centers of Clinically Oriented Research (SCCOR)program to replace the old SCOR mechanism.

Dr. James Kiley, Director, Division of Lung Diseases, NHLBI, explained that the Division of Lung Diseases currently supports three SCOR programs that are in their second (and final) 5-year period of funding.  Therefore, in October 2003, a panel of experts met to review ideas solicited from the scientific community for new SCCOR programs.  Dr. Kiley presented three new initiatives based on the recommendations of the panel: a SCCOR on Chronic Obstructive Pulmonary Disease (COPD), a SCCOR in Pulmonary Vascular Disease, and a SCCOR in Host Factors in Chronic Lung Diseases.  These are proposed to begin in FY 2007 to replace the current SCORs.  Council members were enthusiastic about all three initiatives.

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VIII.    GENERAL RECOMMENDATIONS - Dr. Deborah Beebe

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Once a year Council must approve the General Recommendations of the NHLBI Advisory Council must be reviewed and approved by Council on an annual basis and this is usually done at the February Council meeting.  Dr. Beebe, Director of the Division of Extramural Affairs, presented the recommendations, which allow NHLBI staff to take certain administrative actions, and council unanimously approved them.

IX.    STREAMLINING COUNCIL PROCESS - Dr. Robert Musson

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Dr. Robert Musson, Deputy Director, Division of Extramural Affairs, NHLBI, described the Institute’s recent efforts at streamlining Council preparation. An NHLBI committee was convened to review the existing administrative process.  New technology which involves the Electronic Council Book and the new NIH database (IMPAC II) has aided this process.

Dr. Musson described the Special Action List which has replaced the Special Action Memo and which is significantly reduced in size (3 pages as opposed to >100).  Council’s review of this list during the CLOSED portion of the meeting is expected to be more highly focused.  Council members were enthusiastic about the changes which will enhance efficiency.

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.

X.    REVIEW OF APPLICATIONS

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The Council considered 968 applications requesting $1,165,021,266 in total direct costs.  The Council recommended 967 applications with total direct costs of $1,160,769,798.   A summary of applications by activity code may be found in Attachment B.

ADJOURNMENT

The meeting was adjourned at 2:45 p.m. on February 12,2004.

 

CERTIFICATION

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

Barbara Alving, M.D.
Acting Chairperson
National Heart, Lung, and Blood Advisory Council
on 3/17/04

Deborah Beebe, Ph.D.
Executive Secretary
National Heart, Lung, and Blood Advisory Council
on 3/16/04
 

NOTE: A complete set of open portion handouts are available from the Executive Secretary.

 

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