NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
May 9, 2002

I.  CALL TO ORDER AND OPENING REMARKS - Dr. Claude Lenfant

Member Updates

Dr. Lenfant introduced the new Council members: Dr. Robert J. Mason, Professor of Medicine at the National Jewish Medical and Research Center, Cetalie and Marcel Weiss Chair of Pulmonary Diseases and the Director of the National Research Center for Environmental Lung Disease; Dr. Jane Newburger, Associate Cardiologist-in-Chief and Director of the Clinical Research Service at the Children’s Hospital in Boston, Massachusetts and Associate Professor of Pediatrics at Harvard Medical School; Dr. Ananda Prasad, Professor in the Department of Internal Medicine at Wayne State University and the former Director of the Division of Hematology; Dr. George Thomas, President and Chief Executive Office of the Bradenton Cardiology Center in Bradenton, Florida, and Chair of the IMG Section of the American Medical Association; and Dr. Linda Van Horn, Professor in the Department of Prevention Medicine at North Western University Medical School.

Drs. Rosenberg and Spragg were unable to attend the Council meeting.

Guests

Dr. Lenfant introduced the guest speaker Dr. Edward Clark, who is the Wilma T. Gibson Presidential Professor and Chair, Department of Pediatrics, at the University of Utah School of Medicine.

Personnel Announcements

Dr. Lenfant announced that Dr. Charles Peterson was selected as the Director of the Division of Blood Diseases and Resources.  Dr. Denise Simons-Morton has been appointed as the new Acting Director for the Clinical Applications and Prevention Program in the Division of Epidemiology and Clinical Applications (DECA).  In addition, Ms. Suzanne White has been appointed as Chief, Grants Operations Branch, in the Division of Extramural Affairs.

Dr. Lenfant announced that Dr. Elias Zerhouni was confirmed as the Director of NIH. He previously held the positions of Martin Donner Professor of Radiology of John Hopkins University and the Executive Vice Dean of the John Hopkins School of Medicine.

In addition, Dr. Lenfant informed Council of the death of Dr. Peter Frommer on March 7, 2002. Dr. Frommer was a long-time colleague at NHLBI. He served as NHLBI Deputy Director for 20 years and continued to be involved in various projects as Deputy Director Emeritus.

New Publications

Dr. Lenfant referred Council to the briefing books which included a Legislative Update, the Report of the BEA, the BEA initiatives, reprint requests, the February 2002 Council Minutes, NHLBI News Events, and a list of important NIH websites.  Publications included a copy of the public interest newsletter, the NHLBI Report of the Pediatric Cardiovascular Disease Task Force and the Morbidity and Mortality 2002 Chart Book on Cardiovascular, Lung and Blood Diseases.

II. REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST - Dr. Claude Lenfant

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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 8:00 a.m. and remain open until approximately 12:00 p.m. Dr. Lenfant also reminded the Council members that they are Special Government Employees and are subject to departmental conduct regulations.

III.  REPORT OF THE PEDIATRIC CARDIOLOGY TASK FORCE - Dr. Edward Clark

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Dr. Edward Clark presented the report on the Pediatric Cardiovascular Disease Task Force.  Heart disease in infants, children, and adolescents is a large and under-appreciated public health problem.  Diseases range from congenital structural defects present at birth to genetic abnormalities of the heart muscle and conduction system, acquired heart diseases, and adult diseases that begin in childhood.  Because children have a long life ahead, the burden and cost of children’s heart disease are substantial for families and society.  More than 1 million adults are alive today who had a heart defect repaired during childhood.

In January 2001, the National Heart, Lung, and Blood Institute (NHLBI) convened the Task Force on Research in Pediatric Cardiovascular Disease to identify research priorities and scientific opportunities for addressing this significant public health problem.  The Task Force recommended that the NHLBI support an aggressive research program in the basic, clinical, and population sciences to capitalize on recent advances in genetics, understanding of cardiovascular development, and clinical care.

The Task Force report encompassed three broad areas: basic research on cardiovascular development and the causes of cardiovascular disease, research to improve clinical outcomes, and population strategies to reduce cardiovascular disease in adults by altering risk factors during childhood. Implementation of the Task Force's recommendations could help to foster prevention of pediatric cardiovascular disease; improve outcomes for infants, children, and adolescents with heart disease; and promote cardiovascular health among adults.

The Task Force identified eight research priorities over the next 5 years.  These priorities reflect current scientific opportunities in the following areas:

• Fundamental studies of the formation of heart and blood vessels

• Development and use of new and improved technologies to image the heart

• Advanced repair of congenital heart defects in infants and children

• Refined surgical treatment of human fetuses with heart defects

• Exploration of stem cell biology for the repair of heart tissues

• Creation of improved biomaterials through tissue engineering

• Translational research to enhance clinical care

• Definition of the childhood antecedents and risk factors for atherosclerotic heart disease in adults.

The first priority, cardiovascular morphogenesis, or the formation of heart and blood vessels, deserves research emphasis, to define the mechanisms of normal and abnormal morphogenesis and the role of genetic and epigenetic (environmental) factors in the development of these tissues.  Basic research on these processes will yield important information on the effects of genetic and environmental risk factors and the interactions between genes and the environment in the development of heart defects.  Investigators will need resources to support comparisons of genetic factors in children who have congenital heart defects with experimental models.  This research could yield options for preventing heart defects.

By using advanced technologies to image the heart, researchers also could greatly improve the clinical care of children with heart defects.  The Task Force recommended support of targeted programs to develop and use new and improved technologies for creating two- and three-dimensional images and assessing heart function. To accomplish this work, pediatric heart centers and technology companies must establish partnerships to develop new equipment for assessing heart disease in infants and children, to define its appropriate applications, and to determine its cost effectiveness.  Use of bioinformatics is particularly important for cardiologists and surgeons who need to have real-time images of the heart combined with sophisticated measures of vascular and muscle function.

Surgeons and cardiologists can enhance their repair of congenital heart defects in infants and children by using minimally invasive surgery guided by robotics, new types of therapy with catheters, and improved pre- and post-surgical support of heart and lung function.  The Task Force recommends research to improve heart assist devices and technology for extracorporeal membrane oxygenation and to adapt this technology for use in infants and small children.

Surgical treatment of the human fetus is imminent.  To take advantage of this opportunity to repair heart defects in utero, researchers need to develop new techniques and tools for imaging and surgically repairing the heart. Support of multicenter, collaborative studies of the natural history of heart defects in utero and the efficacy of interventions before birth would greatly help to facilitate this research.

Stem cell biology and tissue engineering also offer the potential to improve the outcomes of treatment for children with heart defects.  Stem cells are a potential source of heart muscle cells and blood vessels which clinicians can use to rebuild or replace damaged heart tissue and thereby obviate the need for heart transplantation.  In addition, researchers could program stem cells to produce artificial valves, blood vessels, and tissue for patches, thereby avoiding complications currently associated with the use of cardiac prosthetic materials.

Establishing a clinical trials network to implement multicenter, randomized studies for rapidly assessing new therapies will accelerate the translation of research advances into clinical care.  Research on clinical outcomes also is critical to implementation and development of standards of care for pediatric cardiology.  Because children potentially have a long life ahead, longitudinal studies and patient registries are important for, and integral to, defining the risk of specific heart defects, appropriate surgical management, and late postoperative complications.  Clinicians need to develop surrogate markers to predict optimal outcomes and identify "best practices" for various diagnoses of heart disease and across heart research centers.

Atherosclerotic heart disease in adults begins early in life.  The Task Force recommends studies that define the origins of atherosclerotic vascular disease during fetal life and childhood. Development of effective therapeutic and preventive regimens depends on research strategies to identify children at high risk for future cardiovascular disease.

The Task Force detailed specific recommendations for each priority area.  In addition, the Task Force urged action to develop and nurture an adequate, well-trained work force in academic pediatric cardiology to conduct the research needed.  The future of children’s cardiovascular health depends on having an adequate work force of pediatric cardiologists, other pediatric specialists, and basic scientists to translate research findings and provide quality care.  The Task Force noted concerns that the number of physicians adequately prepared for these important roles is declining, at a time when the opportunity to achieve significant scientific advances is great.  The Task Force urged the scientific community to devise ways to recruit and nurture the next generation of clinician scientists to conduct basic, clinical, and translational research in pediatric cardiovascular disease.

The issues and recommendations discussed by the Task Force are central to the long-term goals of understanding the causes of pediatric heart diseases, improving clinical care, and eventually preventing these diseases and their complications.

Council congratulated the Task Force for its effort.  Council noted that there was an explosion in technological advances in pediatric heart disease but that there was much more work to be done.  Council emphasized the complexity of the gene/environment interaction.  Even though heart disease is the leading cause of infant death, industrial support is lacking which highlights the importance of NHLBI support.  Current imaging methods for adults are not suitable for infants which requires more research which industry is not supporting.  There is a tremendous opportunity to explore many mechanisms of disease.  Advances in pediatric heart disease will have a life-long effect on families as well as a significant impact on adult diseases.  Considering the significant rise in obesity in children, the role of diet and psycho-social problems need to be addressed as well. Council also discussed the need for more career development and to attract more people to pediatric cardiology research. In further discussion it was noted that there are 42 institutions which train pediatric cardiologists for clinical careers and only a small number of those provide the scientific mentoring required to promote research.  As a result very few investigators devote more than 50% of their time to research.  Dr. Lenfant emphasized that potential applicants need to apply for the various research mechanisms available so that NIH can assist them.

Following the discussion Dr. Lenfant presented Dr. Clark with a plaque in appreciation of his leadership as Chair of the Task Force on Research in Pediatric Cardiovascular Disease.

VI.  LOAN REPAYMEMT PROGRAM - Dr. Claude Lenfant

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Dr. Lenfant described the Loan Repayment Program (LRP) to Council. Dr. Lenfant chaired the NIH committee which developed this program.  There is significant interest in this program which represents the outcome of the Clinical Research Enhancement Act several years ago.  There are two new programs including the Clinical Research LRP for clinical research and the Pediatric LRP which includes both basic and clinical research. NIH decided to issue both programs simultaneously.  NHLBI received 105 applications which was the largest number received by any institute.  Eligibility was determined by the Office of Loan Repayment after which the applications were sent to the various Institutes for review.  The main eligibility criteria was that the candidate must have two years of NIH support remaining on their grant.

Seventy-one applications were received for the Clinical Research Program while 34 were received for the Pediatric Research Program.  NHLBI convened a working group of Council comprised of thirteen people with clinical research experience.  The chairman of the Committee was Dr. Eugene Braunwald.  There were four cardiologists, four pulmonologists, and four hematologists on the committee.  The applications were not evaluated for scientific merit since the research had already been peer reviewed.  The applicants had to provide letters from mentors with a detailed assessment of the applicants and a description of the research.  The applications were scored on a scale of 1-5 (1.0 being the best and 5.0 being the worst).  There were two reviewers per application.  There was general uniformity in the opinions of the group.  Dr. Lawrence Friedman who is the Institute Assistant Director for Clinical Research and Bioethics organized the review.

Council questioned whether there would be a backlog of applications.  Dr. Lenfant noted that the NIH committee expected many more applications (2000) but only received approximately 700 so that at this point there was no backlog.  Dr. Lenfant added that an applicant can not reapply.  The process will be redefined for next year since applicants will not be required to have NIH funding although they must have funding from another source.  Dr. Friedman noted that most of the applications for the Pediatric LRP were clinical research. Dr. Lenfant noted that NHLBI expects to fund 59-60% of the applications.  Council concurred that this level of funding was encouraging and hoped it would attract more basic and clinical researchers.

VII.  BOARD OF EXTRAMURAL ADVISORS WORKING GROUP - Dr. Claude Lenfant

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Dr. Lenfant introduced the BEA initiatives to Council.  The BEA is a working group of Council comprised of senior investigators who are appointed for their broad-based knowledge and experience as opposed to representing specific scientific disciplines.  The role of the BEA is to provide advice on the future direction of science.  BEA meets two times a year to discuss initiatives developed by NHLBI staff. Such initiatives result from recommendations made by workshops or other forums and are routinely developed after discussions with the scientific community.  For example, the recommendations from the Pediatric Task Force will more than likely be further discussed and result in one or more initiatives.  This process has been in effect for two years and has been largely successful.  After discussion of each initiative, the BEA is asked to assign a level of interest for each.  The initiatives are then ranked in priority order, and presented to the Council, who is responsible for review of all concept documents prior to their release to assure the importance and timeliness of the program to the NHLBI.  Some initiatives are continued for many years such as CARDIA (Coronary Artery Risk Development in Young Adults) which is up for its fourth renewal, but such initiatives must be reviewed and evaluated every 5 years.  Dr. Lenfant emphasized that the Institute must establish priorities in order to accommodate the finite budget. 

VIII.  INITIATIVES FOR FISCAL YEARS 2003/2004 - Dr. Claude Lenfant

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1. Cardiopulmonary Genomics (CPG) Consortium

The primary goal of the cardiopulmonary genomics consortium is to develop a well-classified gene expression database for heart, lung and blood diseases.  This will be accomplished through standardization of the collection of tissues of interest, standardization of the molecular analysis and presentation of the results of these tissues, and provision for a robust, publically available database that will allow for the identification of important molecular targets.  It is envisioned that this approach will significantly hasten new therapeutic regimens for cardiopulmonary diseases, and provide physicians and patients with information that could facilitate a better understanding of their disease process.

Council comments were favorable and further development of this initiative was encouraged; Council agreed with the concerns of BEA, i.e. collection of tissues, standardization, and types of diseases, but felt that these could be addressed.

2. Centers for Transactional Research in Peripheral and Pulmonary Vascular Diseases

This program aims to develop improved therapeutic and preventive approaches for arterial, venous, and lymphatic diseases of the peripheral and pulmonary vasculature through research projects that link basic and clinical investigations by closely integrated, multi-disciplinary approaches.  Key objectives include: 1) elucidating biological mechanisms related to the initiation, progression, and outcomes of disease; 2) enhancing early detection of disease by developing improved imaging approaches and other technologies; 3) improving prevention and therapy by development and systematic evaluation of existing and novel strategies; 4) developing a cadre of well-trained new investigators in vascular medicine; and 5) facilitating improved detection and treatment of these conditions through education of physicians and other health care providers, patients, and the public.

Council agreed with BEA’s assessment that there be a focus on peripheral vascular disease.  This initiative was thought to be of high priority. 

3. Chronic Obstructive Pulmonary Disease (COPD) and the Development of Lung Cancer

The goal of this initiative is to identify cellular and molecular mechanisms responsible for the comorbidity of COPD and lung cancer; to develop animal models appropriate for study of the interactions between airway inflammation and tumor development and growth; and to perform preclinical testing of the concept of lung cancer chemoprevention by treatment of chronic airway inflammation.

Council had a high degree of enthusiasm for this initiative.  It agreed that there were new technologies to allow significant progress to be made in this area.

4. Churg-Strauss Syndrome Registry (CSSR)

The goal of this initiative is to establish and support a registry of clinical data, tissue specimens, and blood samples to characterize the underlying pathophysiology of Churg-Strauss Syndrome (CSS) and its relationship to asthma and asthma treatment.  The standardized collection of information will facilitate future pathological, cellular and molecular mechanistic studies of this rare disease.

Council agreed with BEA’s assessment and had moderate enthusiasm for this initiative.

5. Clinical Research Consortium for COPD

The goal of this initiative is to establish a research Consortium to perform multiple, short-term clinical trials addressing management questions in individuals with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).  The major emphasis of this Consortium will be on management of acute exacerbations and near-terminal cases.  Studies of novel agents will be allowed, but it is expected that the majority of studies performed will involve drugs that are in common use but whose effectiveness is unproven.  Approximately 5 clinical trials will be completed during the 5 years of this program.  The Consortium will be funded as a Cooperative Agreement and will consist of 8-10 Clinical Centers and a Data/Coordinating Center.  A Steering Committee, composed of Clinical Center and Data/Coordinating Center Principal Investigators and the NHLBI Program Office, will select the specific trials to be performed, establish standards for subject selection and characterization, develop detailed protocols for the trials, and analyze and publish the results.

Council gave this initiative very high priority since adequate treatment of these patients is lacking.

6. Coordination of Vascularization and Lung Development

The goal of this initiative is to understand the fundamental relationships between vasculogenesis, angiogenesis/angiostasis modulation, and the developing lung in order to select rational therapeutic intervention for correcting arrested/aberrant lung development.

Council was very supportive of this initiative to deal with "new" Broncho Pulmonary Dysplasia (BPD). Proposed studies will examine alveolar and vascular components in survivors of low birth weight.

7. Coronary Artery Risk Development in Young Adults (CARDIA) Study - Renewal

CARDIA, with 15 years of data, high retention rates, and stored samples, offers a unique opportunity to study the development of atherosclerosis in adults in their 40s–an age when the earliest detectable subclinical disease appears to accelerate.  A Year 20 exam will address questions that cannot be examined in older cohorts, such as (1) which risk factors are related to earlier development and more rapid progression of subclinical atherosclerosis, (2) if racial differences in severity and progression of subclinical disease reflect distinct pathologies and possible differences in cardiovascular disease (CVD) development, (3) which genes are related to subclinical disease and its risk factors, and (4) if inflammation precedes subclinical disease.

Council was very enthusiastic about continuing this important study.

8. Detection of Occult Infectious Agents in AIDS and Other HLB Diseases

Opportunistic infections clearly worsen the prognosis and cause the demise of many patients with HIV and other immune disorders.  Both known and unknown agents are responsible, but the latter are not sought because symptoms of fatigue and malaise are often attributed to HIV and degenerative diseases rather than to co-factors.  Research is needed to develop a generic screening method to detect multiple occult infectious agents in AIDS patients and HLB disorders, such as cardiomyopathies, vasculitides, and pulmonary fibroses/granulomatoses.  This work could revolutionize our concepts about the causes of these diseases, which may be applied to screen the national blood supply.

Council had low to moderate enthusiasm for this initiative and agreed with the concerns of BEA.

9. Functional Heterogeneity of Pulmonary and Peripheral Vascular Beds

The objective of this initiative is to support research to characterize the functional heterogeneity within the adult vasculature including the pulmonary circulation and peripheral arteries, veins, and lymphatics.

Council agreed with BEA that this initiative should be better developed.

10. Hypovolemic Circulatory Collapse: Mechanisms and Opportunities to Improve Resuscitation Outcomes

This initiative is intended to encourage basic research using novel approaches to identify the molecular, biochemical, and pathophysiologic mechanisms responsible for the transition from severe hypovolemia to irreversible circulatory collapse.  Results of these studies will help identify new therapeutic targets to improve resuscitation from the early, out-of-hospital, effects of severe hemorrhage.

Council concurred with BEA’s assessment and suggested that more specifics and better focus would be essential for this important initiative.

11. Immunobiology of Transfusion Medicine

The intent of this solicitation is to encourage investigations of basic mechanisms of alloimmune reactivity involving the transfusion recipient’s immune response to transfused cells and plasma derivatives and/or involving the immune responses mediated by transfused products on antigenic targets in recipients.

Council recommended expanding this initiative according to BEA’s suggestions.

12. Immunological and Physiological Studies in Heart and Lung Xenotransplantation

 The objectives of this initiative are to elucidate the mechanisms underlying the immunological and physiological hurdles to successful clinical application of xenotransplantation of hearts and lungs and to identify potential strategies to overcome these hurdles.

Council was moderately enthusiastic about this initiative.  While it was noted that industry is currently not engaged in this research, Council shared BEA’s enthusiasm for developing cell-based therapies and devices.

13. Immunotherapeutic Approach to HIV Infection

This initiative’s goal is to foster research on dendritic cell (DC)-based immunotherapy in HIV-infected patients. Although combined therapy with drugs directed at the virally encoded reverse transcriptase and protease enzymes can control AIDS in some patients for several years, many patients cannot tolerate this form of treatment while others, who receive it, develop a resistant strain of the virus.  Therefore, alternative therapeutic approaches are urgently needed, especially ones that are well tolerated and target the virus with strategies that differ from and can potentially complement standard drug-based approaches. Ideally, new treatment modalities should focus on the body’s natural immune defense system to stimulate anti-HIV immunity.

Council agreed with the low enthusiasm of BEA for this initiative.

14. Innovative Research in Genetics and Genomics Utilizing the Framingham Heart Study

 The goal of this initiative is to promote enhanced utilization of the unique resources of the Framingham Heart Study for identification of genetic and environmental factors related to heart, lung, blood, and sleep disorders. The comprehensive, standardized information collected from two generations of Framingham residents provides a far richer resource than any single group of investigators can fully explore, but the specialized genetic expertise needed to realize its potential is currently in high demand.  This program will support highly innovative, potentially high impact research from the broad scientific community in order to capitalize on this unique resource.

Council was very enthusiastic about this initiative but emphasized that the issue of access to the Framingham database needs to be addressed.

15. Inter-relationships of Sleep, Fatigue, and HIV/AIDS

The objective of this initiative is to elucidate the etiology of sleep disturbances and fatigue associated with human immunodeficiency virus (HIV) infection and acquired immunodeficiency disease syndrome (AIDS); to develop approaches to improve the sleep of HIV-infected patients; and to improve the fundamental understanding of the relationship between sleep and chronic disease.

Council was more enthusiastic than BEA for this initiative.

16. Lung Microenvironment in Lung Cancer Growth and Metastasis

The objective of this initiative is to encourage innovative and collaborative investigations by pulmonary and cancer investigators to elucidate the relationship between the lung microenvironment and lung cancer growth and metastasis.  This new program would encourage applications that investigate how the lung microenvironment interacts with tumor cells to support and stimulate the growth of micrometastases and primary lung tumors.  How the lung environment contributes to the metastatic potential of lung cancers will also be explored.

Council was very enthusiastic about this initiative which introduced compelling questions and would give it a higher ranking.

17. Maintenance of a Chimpanzee Colony for AIDS and Hepatitis Research

The purpose of this initiative is to continue the maintenance of the NHLBI chimpanzee colony currently comprised of 48 animals.  These chimpanzees are to be utilized in non-destructive experiments judged most likely to advance knowledge on acquired immunodeficiency syndrome (AIDS) or hepatitis research and lead to the control or elimination of these infectious diseases associated with the transfusion of blood or blood products.

Council concurred with BEA that this is an important resource and should be maintained; it noted that active protocols are proposed as well.

18. NHLBI DNA Re-sequencing and Genotyping Centers

The goal of this initiative is to establish high-volume, NHLBI DNA Re-sequencing and Genotyping Centers that will discover and type DNA variation which is needed to elucidate the genetic components involved in the cause, variable outcome, and progression of heart, lung, blood, and sleep diseases and disorders.

Council was very enthusiastic about this initiative which is urgently needed from a public health perspective in so far as it will provide genotyping on a population base level.

19. NHLBI GENELINK

The objective of this initiative is to provide the infrastructure to 1) promote sharing results of linkage analyses, 2) facilitate data sharing and pooling among genetic linkage studies and 3) provide a forum for development of collaborative studies to follow up linkage analyses.  The overall goal of this initiative is to promote a collaborative approach to gene finding in NHLBI funded family studies, thereby fully utilizing existing data and increasing the yield and reliability of linkage results for pursuing fine mapping, gene identification, and characterization.  It is expected that within three years as a result of this initiative we will have: (1) a dynamic website for sharing of pre and post-publication data and results among NHLBI funded investigators, (2) a forum for open discussion of collaborative efforts to pursue the genetics of complex HLB disorders and (3) several new grant applications to pursue collaborative genetic research efforts among the participating NHLBI studies. The ultimate result of this program will be to increase the scientific yield from NHLBI linkage studies.

Council concurred with BEA that this is a very important proposal and indicated that the issues of pre-published data will need to be addressed.

20. NHLBI Lung Tissue Resource

The goal of this initiative is to facilitate studies of pulmonary diseases by establishing and supporting a program for the standardized processing, storage, and distribution of lung tissues and associated clinical data. This resource will enable investigators to perform studies correlating molecular histopathology of the lung with pulmonary function and clinical status.

Council concurred with BEA’s moderate enthusiasm for this initiative.

21. Pediatric Mechanical Circulatory Support Research and Development

The major objective of this initiative is to develop mechanical assist devices, including extracorporeal membrane oxygenation (ECMO) systems, left ventricular assist devices (LVADs), and other bioengineered systems for children with congenital and acquired cardiovascular disease.  The program would provide basic physiological and bioengineering data necessary for the design of effective pediatric assist and replacement devices while also supporting phase I studies to explore innovative strategies to meet the clinical needs of the pediatric patient population.

Council concurred with BEA’s assessment and recommended this initiative.

22. Pulmonary Complications of Sickle Cell Disease

The objective of this initiative is to stimulate basic and clinical research on the pulmonary complications of sickle cell disease.

Council was enthusiastic about this initiative which would attract pulmonologists to study this sickle cell syndrome.

23. Regional Haplotype Maps: Applications to Complex Diseases

This initiative would encourage the application of genomic approaches to understanding complex disease biology and provide the biological support for the utilization of a Genome-Wide Haplotype Map (HapMap).

Council agreed with BEA’s assessment and concurred that it was appropriate to do these studies at this point.

24. Relationships Between Metabolic Syndrome and Sleep Disordered Breathing or Chronic Sleep Deprivation

 The goal of this initiative is to study the effects of restricted sleep schedules, sleep disordered breathing (SDB), or other sleep disorders on the development of the metabolic syndrome (obesity, hypertension, dyslipidemia, insulin resistance), and to study relevant mechanisms.

Council was more enthusiastic than BEA for this initiative since this program is interdisciplinary and would have a large impact as well as enormous potential yield.

25. Sex Differences in Heart Health and Disease

This initiative would encourage research to identify sex differences in the function of the heart, elucidate the fundamental cellular, molecular and genetic mechanisms responsible for sex differences and to determine the role sex differences play in cardiac disease.

Council was more enthusiastic than BEA since this is a very important area although it is difficult to translate into clinical practice as a result of physician bias and health disparities.

Following the presentation of initiatives, there was a general discussion concerning the initiative process.        Dr. Lenfant indicated that staff will discuss modification of the process and present it to Council at the next meeting.

CLOSED PORTION

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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.

IX.  REVIEW OF APPLICATIONS   

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The Council considered 899 applications requesting $1,175,987,265 in total direct costs.  The Council recommended 890 applications with total direct costs of $1,164,742,186.  A summary of applications by activity code may be found in Attachment B. 

X.  RECOMMENDATIONS FOR LOAN REPAYMENT PROGRAM

The Council members were provided with the results of the Loan Repayment Working Group.  There was a brief discussion and Council concurred with the recommendations.

ADJOURNMENT  

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The meeting was adjourned at 5:00 p.m. on May 9, 2002.

CERTIFICATION

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

Claude Lenfant, M.D.

Chairperson

National Heart, Lung and Blood Advisory Council

on 07/09/02