NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

May 13, 2004

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

Dr. Barbara Alving, Acting Director of the National, Heart, Lung, and Blood Institute opened the meeting and welcomed the Council members to the 214th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Dr. Alving announced that May is National High Blood Pressure Education month. This is the time each year when organizations across the country join together to increase public awareness of High Blood Pressure and promote improved prevention and control. This year NHLBI is encouraging even more organizations than usual, including businesses, community groups, civic and faith based organizations, hospital outreach programs, public health departments, and workplaces to take action this May and conduct activities to prevent and control high blood pressure.

Member Updates

Ms. Deer was unable to attend the meeting.

Speakers

The following speakers were introduced:

1. Dr. Story Landis, Director, National Institute on Neurological Diseases and Stroke

2. Dr. Richard Hodes, Director, National Institute on Aging

3. Dr. Larry Fields, Senior Executive Advisor to the Assistant Secretary for Health in the Office of the Secretary’s Office of Public Health and Science.

Management Status

The search for the NHLBI Director is continuing and a new Director may be selected by early summer.

Personnel Changes

Dr. Alving announced several new staff appointments:

Dr. Valerie Prenger is the new Chief of the Review Branch, Division of Extramural Affairs.

  1. Dr. Sonia Skarlatos is the Deputy Director, Division of Heart and Vascular Diseases.
  2. Dr. Diane Bild is the Deputy Director, Division of Epidemiology and Clinical Applications.
  3. Dr. Liana Harvath is the Deputy Director, Division of Blood Diseases and Resources.

Publications

The following items and publications were provided:

Pedometers: NHLBI has provided peodometers to the staff in conjunction with the new NHLBI program “PALS” which stands for Physical Activities & Lifestyles (PALS). The primary goal is to increase physical activity levels in all interested NHLBI employees by providing fun and challenging physical activity opportunities.

The report of the conference on Frontiers of Knowledge in Sleep and Sleep Disorders: Opportunities for Improving Health and Quality of Life.

The Morbidity and Mortality 2004 Chart Book on Cardiovascular, Lung, and Blood Diseases.

A copy of the Education Materials Catalog, which shows all the materials available from the NHLBI.

 

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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 the 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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II. REPORT OF THE ACTING DIRECTOR - Dr. Barbara Alving

Dr. Alving stated that Dr. Zerhouni, Director, NIH, had convened a Blue Ribbon Panel to look at conflict of interest issues at NIH and also testified before a committee convened by Congressman Greenwood. This is an ongoing process.

The NIH has testified before the Senate and the House Appropriations Committees. There was significant interest in both stem cell research and obesity.

Budget Report

Ms. Sandra Gault, Chief, Financial Management Branch, NHLBI, reviewed the current Institute paylines for several funding mechanisms. The research project grant (RPG) payline is currently at the 25.0 percentile. Ms. Gault also mentioned that the Institute is closely monitoring the number of competing grants being funded since it is required each year to achieve a certain number.

Dr. Alving noted that this adequate payline was achieved by careful planning. Future planning will be necessary since the budget will probably be plateauing.

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IV. PROGRAM PROJECT GRANTS – Dr. Carl Roth

Dr. Carl Roth, Associate Director for Scientific Program Operation, NHLBI, discussed recent modifications to the Institute’s Guidelines for Program Project Grants. The most significant change is the deletion of the requirement that not less than half of the component projects and at least half of the cores submitted and funded be in the applicant institution. Each project can be located at a separate institution without any geographic restrictions. Other changes include a new provision that no more than fifty percent of the projects included in a P01 application can be currently funded as R01 grants, that the interrelationship and synergy of each project within a program project grant application must be unequivocally demonstrated, and that the principal investigator of a program project grant must be a research scientist “of recognized stature in his/her scientific discipline,” a stronger requirement than the one previously included in the Guidelines.

Council members agreed with the modifications and suggested more emphasis on the demonstration of synergy within program project grant applications and on whether proposed cores are essential to the research projects. The policy changes will be effective starting with applications submitted for the February 2005 receipt date (i.e., FY 2006 awards).

In addition, Dr. Alving stated that NHLBI is considering streamlining the review of program project grant applications.

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V. BOARD OF EXTRAMURAL ADVISORS WORKING GROUP: INITIATIVES FOR FISCAL YEARS 2006/2007- Dr. Barbara Alving and Dr. Peter Savage

 NHLBI staff presented sixteen new initiatives that had been reviewed by the Board of Extramural Advisors on April 20. 2004.

1. The Atherosclerosis Risk in Communities (ARIC) Study

 OBJECTIVES: This continuation of ARIC will assess trends in incidence of myocardial infarction (MI) and heart failure (HF) and identify their risk factors in four diverse communities. Specifically, it will: 1) extend community surveillance of trends in MI incidence through 2009 and beyond age 74; 2) initiate surveillance of HF; and 3) continue laboratory investigation of novel risk factors for coronary heart disease and HF in ARIC cohort members aged 45-64 at study entry.

Council was supportive of this initiative and noted that broadening the age beyond 74 was appropriate.

2. Biomechanics and Morphogenesis of Cardiac Structures

OBJECTIVES: The purpose of this initiative is to focus research on the biomechanical and morphogenic processes that direct the embryonic development of left/right asymmetry and the specialized structures of the cardiac conduction system and coronary vasculature.

Council suggested broadening the initiative to include flow stress.

3. Causes and Mechanisms of COPD Exacerbations

 OBJECTIVES: The objective of this initiative is to investigate the causes of and molecular pathways involved in acute exacerbations of chronic obstructive pulmonary disease.

Staff assured Council that this initiative filled a gap in areas not being covered by ongoing networks and the new Specialized Centers of Clinically Orientated Research (SCCOR) initiatives in the future. Council considered this initiative to be important.

4. Directed Stem Cell Differentiation for Cell based Therapies for Heart, Lung, and Blood Diseases

OBJECTIVES: The purpose of this initiative is to define the factors controlling the differentiation of stem cells in vitro or in vivo. The long range goal is to develop methods to direct differentiation of stem cells to yield replacement cells for clinical use or to develop methods to stimulate differentiation of resident stem cells in vivo for regeneration or repair.

Council was enthusiastic about this initiative.

5. Effects of Sleep Disorders and Sleep Restriction on Adherence to Cardiopulmonary Disease Treatment Regimens

OBJECTIVES: (1) Define the relationship of sleep disorders and restricted sleep schedules to adherence to medical (e.g. pharmacological) and behavioral (e.g. weight loss) interventions for non-sleep-related cardiopulmonary disorders; (2) determine if sleep behaviors can be improved and if improved sleep behaviors affect adherence or measures of health outcome.

Council thought that this was a significant public health problem and encouraged including nutrition factors as well.

6. Heart Failure Clinical Research Network

OBJECTIVES: The intent of the program is to establish a stable infrastructure to conduct clinical studies of novel strategies to improve outcomes for patients with heart failure by forming strong partnerships with the research and practice communities and industry.

Council was very enthusiastic about this initiative and with the network approach in general which speeds knowledge delivery, encourages collaborations and helps to standardize care.

7. Infectious Agents in the Early Origins, Etiology, and Pathogenesis of Chronic Lung Diseases

OBJECTIVES: The objective of this initiative is to support innovative research to define the role of bacterial, fungal, and viral infectious agents in the early origins, etiology, and pathogenesis of chronic lung diseases.

Staff emphasized that this initiative will focus on the early origins of disease and Council recommended this research.

8. Molecular and Clinical Research on Aortic Aneurysmal Diseases

OBJECTIVES: This initiative will stimulate clinical and multidisciplinary basic research studies to investigate the cellular and molecular mechanisms of aortic aneurysmal diseases and dissections.

Council recommended this initiative based on the lack of research in the area and the clinical need. Inclusion of Marfan syndrome research was suggested.

9. Neuro-Circulatory Control of Cardiovascular Function and Disease Progression

OBJECTIVES: This initiative seeks to elucidate important relationships between the heart and the brain and the role the relationships play in the genesis of arrhythmias, the response to ischemia, and the progression of both hypertension and heart failure. The intent is to stimulate the integration of new cutting-edge techniques to discover how the central and peripheral nervous systems cause or influence disease. The techniques to be integrated include molecular imaging, computational biology, mathematical modeling methods, and the ability to make simultaneous measurements of molecular and biophysical phenomena at multiple levels of complexity. New, multidisciplinary collaborations are encouraged between basic and clinical scientists with expertise in structural, molecular, and cellular biology, protein and genetic interactions, signaling and trafficking pathways, cardiology, neurology, and other disciplines. Research in this area is expected to uncover new targets for therapeutic interventions to retard and reverse the continuing increases in morbidity and mortality of heart failure, arrhythmias, and hypertension

Council endorsed this initiative and emphasized the need to bring in young investigators.

10. Next Generation Ventricular Assist Devices for Destination Therapy

OBJECTIVES: This initiative will support the development of the next generation of ventricular assist devices for long-term circulatory support. It will stimulate academic institutions, often with established industry partnerships, and small businesses to ensure biocompatibility and reliability, reduce device size and noise, and increase efficiency for long-term use devices. Through a comprehensive risk management approach, a new generation of devices is expected to minimize serious adverse events, such as infections, thrombosis, and mechanical failure.

Council noted that non-viral methods are still not working well and although research has been going on in this area for the last 10 to 15 years, much more work is needed for non-viral vectors to be used in clinical applications.

Council expressed the opinion that this was an extremely important initiative.

11. Non-Viral Methods for Gene Transfer Applications for Heart, Lung, and Blood Diseases

 OBJECTIVES: This initiative will foster the development of efficient non-viral approaches for a broad range of gene-mediated therapies in humans. Multidisciplinary collaborations between scientists with expertise in structural, molecular and cellular biology nanotechnology and bioengineering will be encouraged.

Council noted that non-viral methods are still not working well and although research has been going on in this area for the last 10 to 15 years, much more work is needed for non-viral vectors to be used in clinical applications.

12. Novel Targets and Therapy Development for Ischemic Stroke

OBJECTIVES: A collaborative effort between NHLBI and NINDS has been established to identify new molecular targets, explore promising agents, and develop novel therapeutics for cerebral ischemia.

Council recommended this initiative and suggested including fibrinolytic agents. Staff added that this initiative had been discussed with the National Institute on Neurological Disease and Stroke.

13. Sickle Cell Disease Clinical Research Network

OBJECTIVE: To create a network that will address critical issues in the care of person with sickle cell disease through the development of a registry and completion of phase I-III clinical trials with an emphasis on phase III clinical trials.

Council was very enthusiastic about this initiative.

14. Studies of Antiplatelet-therapy Resistance (SOAR)

OBJECTIVES: The objective of this initiative is to conduct a multi-center clinical trial to determine whether the composite outcome of death, nonfatal stroke, or nonfatal myocardial infarction can be reduced by antiplatelet/antithrombotic therapy guided by platelet function tests that determine an individual’s response to treatment, compared with standard therapy. Individuals who are screened and found to be eligible for the trial will be entered into an observational study to assess sensitivity and specificity of various in-vitro platelet function assays for predicting the same outcome.

Council recommended this initiative as very timely.

 15. Temporomandibular Joint (TMJ) and Sleep Disorders

OBJECTIVES: The purpose of this initiative is to stimulate research to improve understanding of primary and secondary sleep problems in patients with TMJ Disorder. Despite multiple factors that are likely to increase the risk for sleep disordered breathing (SDB) in patients with TMJ Disorder, no systematic data are available regarding the prevalence of SDB or the extent to which SDB and its cardiopulmonary consequences contribute to adverse outcomes including reduced quality of life. TMJ Disorder is associated with chronic pain, but no data are available regarding the extent to which chronic pain leads to secondary insomnia and the extent to which chronic insomnia also contributes to reduced quality of life.

Council suggested that this initiative might be considered by the National Institute on Dental and Craniofacial Research.

16. Training Programs in Vascular Medicine

OBJECTIVES: This initiative will support comprehensive, multi-disciplinary postgraduate training programs in vascular medicine to prepare clinicians for academic leadership roles in teaching and research. For the purposes of this initiative, vascular medicine is defined as a discipline devoted to clinical evaluation and management of individuals with arterial, venous, and lymphatic diseases.

Council highly recommended this initiative as being critical for expanding the field.

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VI. HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS – Dr. Gail Pearson and Dr. Jeffrey Cutler

Dr. Jeffrey Cutler, Senior Advisor, Division of Epidemiology and Clinical Applications, NHLBI, reviewed the findings of a study, supported in part by the NHLBI, which used National Health and Nutrition Examination Survey (NHANES) data to analyze trends in blood pressure among children and adolescents between 1988 and 2000. The results, published in an article entitled “Trends in Blood Pressure Among Children and Adolescents” in The Journal of the American Medical Association on May 5, 2004, showed that blood pressure levels for children and adolescents have risen substantially over the past decade, in part linked to an increase in prevalence of overweight and obesity. Other potential contributors to the rise in blood pressure, such as changes in physical activity and dietary nutrient intake, were not analyzed in the study. Dr. Cutler emphasized the importance of the results by explaining that increases in blood pressure in children and adolescents of the magnitudes found in the study are estimated to translate into about a 10 percent increase in incidence of hypertension in young adults.

Dr. Gail Pearson, Leader of the Heart Development, Function, and Failure Scientific Research Group, Division of Heart and Vascular Diseases NHLBI, who is now working on the NHLBI pediatric blood pressure education effort presented an overview of the clinical practice guidelines on high blood pressure in children and adolescents (to be released this summer). The main objectives of the guidelines are to update clinicians who care for children about new research findings and to make recommendations about the diagnosis, evaluation, and treatment of hypertension in children. The guidelines include updated blood pressure tables for children and adolescents; definition of a prehypertension category for children; and recommendations for lifestyle approaches and drug therapy, for treating children.

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VII. FUTURE DIRECTIONS IN STROKE RESEARCH AND OUTREACH- Dr. Story Landis, Dr. Richard Hodes and Dr. Larry Fields

The NHLBI looks forward to working with the National Institute on Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), and the Office of Public Health and Science (OPHS), DHHS, on stroke research and outreach. Representatives of each of the organizations spoke about the stroke-related activities of their organizations and described areas of research and/or outreach of mutual interest to them and the NHLBI.

Dr. Story Landis, Director, NINDS, discussed future directions in stroke research from the NINDS perspective. She described an ongoing, large translational program, Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which seeks to translate preclinical research into clinical trials in acute care settings. Another large NINDS study is the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, an epidemiologic study to evaluate the role of risk factors in the Stroke Belt and Stroke Buckle (i.e., Georgia, North Carolina, and South Carolina—states within the Stroke Belt where the highest stroke death rates are clustered). In addition, the NINDS has developed a plan (published in April 2002), representing the recommendations of over 150 stroke experts, to help it identify research opportunities in stroke prevention, diagnosis, treatment, and rehabilitation. Dr. Landis reviewed the plan’s research and resource priorities, and described some examples of how the plan has been implemented. Dr. Landis also noted that the NINDS works to educate the public about stroke.

Dr. Richard Hodes, Director, NIA, described scientific areas of interest to both the NIA and the NHLBI, and discussed several major studies that have involved NIA/NHLBI collaboration. Dr. Hodes reviewed some exciting research findings in areas of interest to both Institutes. For example, becoming physically fit, even after age 60, has been shown to reduce cardiovascular mortality. Dr. Hodes also noted that recent research shows a potential link between cardiovascular disease risk factors and dementia, and that a decreased prevalence of Alzheimer’s Disease has been shown in patients using statin drugs. Dr. Hodes concluded that the NIA is “tied” to working with the NHLBI and the NINDS on studies of stroke in older populations.

Dr. Larry Fields, Senior Executive Advisor to the Assistant Secretary for Health OPHS, DHHS, discussed stroke from a health policy perspective and presented data on stroke and stroke mortality in racial/ethnic sub-populations. He described the Stroke Belt Elimination Initiative (announced by the Office of Minority Health, OPHS, DHHS), which is a community-focused initiative to reduce the burden of stroke in the southern states. One community in each of 3 to 4 states in the Stroke Belt will receive support to implement activities to identify partners and coalitions that focus on stroke and high blood pressure and to develop a “Stroke Belt Community Action Plan.” Dr. Fields also noted that the DHHS Action Team for helping the Stroke Belt comprises many groups, including the NHLBI, the NINDS, and the NIA.

Discussion ensued about opportunities and challenges related to stroke research. Dr. Alving invited Council members to recommend research activities that could be undertaken jointly by the NHLBI, the NINDS, and the NIA.

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VIII. HISTORICALLY BLACK COLLEGE AND UNIVERSITY (HBCU) RESEARCH SCIENTIST AWARD – Dr. John Fakunding

The Historically Black College and University (HBCU) Research Scientist Award is intended to strengthen and augment the human resources at HBCUs by providing an opportunity for them to recruit an established research scientist into their biomedical or behavioral science departments; to enhance the career of the recruited research scientist; and to strengthen other HBCU resources for the conduct of biomedical or behavioral research in areas related to cardiovascular, lung, and blood health and disease; transfusion medicine; and sleep disorders. Dr. John Fakunding, Director of the Heart Research Program, DHVD, explained that four ongoing HBCU Research Scientist Awards are approaching the end of their initial periods. The NHLBI plans to announce, in a few months, a recompetition of the program for another 5 years.

IX . INITIATIVE FOR SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) IN VASCULAR INJURY, REPAIR, AND REMODELING - Dr. Sonia Skarlatos

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. Sonia Skarlatos, Deputy Director, DHVD, NHLBI, explained that two existing SCORs related to vascular diseases are approaching the end of their award periods. Based on the recommendations of an Expert Panel on Vascular Diseases, which met in December 2003, the NHLBI developed a Request for Applications (RFA) for Specialized Centers of Clinically Oriented Research (SCCOR) in Vascular Injury, Repair, and Remodeling to investigate molecular and cellular mechanisms of vascular injury, repair, and remodeling; to promote patient-oriented research to improve prevention, detection, characterization, management, and treatment of vascular diseases; and to develop the skills and research capabilities of new clinical investigators. Awards are expected to be made in FY 2006.

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).

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.

X. REVIEW OF APPLICATIONS

The Council considered 1,173 applications requesting $1,825,689,175 in total direct costs. The Council recommended 1,173 applications with total direct costs of $1,816,125,743. A summary of applications by activity code may be found in Attachment B.

ADJOURNMENT

The meeting was adjourned at 3:45 p.m. on May 13, 2004.

CERTIFICATION

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

Barbara Alving, M.D. Date

Acting Chairperson

National Heart, Lung, and Blood Advisory Council

 

Deborah Beebe, Ph.D. Date

Executive Secretary

National Heart, Lung, and Blood Advisory Council

 
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