NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
October 24-25, 2002

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

Dr. Claude Lenfant opened the meeting and welcomed the Council members to the 208th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Member Updates

Drs. Melissa Austin and Pearl Toy were not present for the meeting.

Retiring Members and Annual Dinner

Dr. Lenfant announced the annual October Council dinner in the evening (October 24) at which time the retiring members of Council would be honored. The retiring Council members are Dr. Alan Cowley, Dr. Paul Douglass, Dr. Amelie Ramirez, Dr. Robert Rosenberg, and Dr. Roger Spragg.

New Council Members

Dr. Lenfant announced the new Council members whose terms begin November 1 and include Dr. Gordon Bernard, Director of the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt School of Medicine; Dr. Maria Costanzo, the John H. and Margaret V. Krehbiel Professor of Cardiology at the Rush-Presbyterian-St. Luke’s Medical Center; Dr. Kim Eagle, the Albion Walter Hewlet Professor of Internal Medicine of the Health System Cardiovascular Center at the University of Michigan; Dr. Frances Henderson, Professor and Dean of the Alcorn State University School of Nursing; and Dr. Ngai Nguyen, private practitioner in San Jose, California as well as an Assistant Clinical Professor of Medicine at the University of California, San Francisco. Dr. Maria Costanzo, Dr. Frances Henderson, and Dr. Ngai Nguyen were present at the meeting.

Committee Representatives

Every year representatives from NHLBI Review Committees are invited to attend a Council meeting.            Dr. Lenfant introduced Dr. Gilbert White, Professor of the Department of Medicine and Pharmacology in the School of Medicine at the University of North Carolina, a member of the Heart, Lung, and Blood Program Project Review Committee; and Dr. Peter Lane, Director of the Hematology program at the Children’s Health Care of Atlanta and the Department of Pediatrics at Emory School of Medicine, and Chair of the Sickle Cell Disease Advisory Committee.

Board of Extramural Advisors

Dr. Lenfant introduced a member of the Board of Extramural Advisors, Dr. Ronald Crystal, who is Director and Professor of the Institute of Genetic Medicine at the Cornell University Joan and Stanford I. Weill Medical College. 

Guest Speakers

Dr. Lenfant introduced three guest speakers:

• Dr. Herbert Geller, Associate Director for Education in the NHLBI Division of Intramural Research who spoke on the mentoring and training programs in the intramural NHLBI. 

• Dr. Elliot McVeigh, a Senior Investigator in the Laboratory of Cardiac Energetics in NHLBI intramural laboratory, who gave a presentation on cardiovascular applications of real-time MRI. 

• Ms. Rosemary Quigley, a member of the NIH Director’s Council of Public Representatives and Assistant Professor at the Center for Medical Ethics and Health Policy at the Baylor College of Medicine, who presented the Committee report on Human Research Protections in Clinical Trials: A Public Perspective.

NHLBI Educational Activities

Dr. Lenfant briefly mentioned a number of institute activities which are supported by contract such as the planning, development, implementation, and evaluation of the National Education Programs and Special Education Initiative activities. The Institute will be issuing requests for proposals for support of these educational activities in FY03.

Mentorship and Training Program - Dr. Herbert Geller

The NHLBI DIR Office of Education was established in September, 2001. The Office has responsibility for mentoring, training and career guidance for DIR personnel, including Summer Interns, post-Baccalaureate Intramural Research and Training Act appointees, Postdoctoral Fellows, Clinical Fellows, and Tenure-Track Investigators. Dr. Herbert M. Geller, Associate Director for Education, DIR, summarized the current activities and present and future plans for expanding the mentoring and training efforts within DIR.

Dr. Geller outlined several approaches the Institute uses to attract high quality scientists such as competitive salaries, loan repayment programs, and career transitions awards (K22). Furthermore, he talked about new ways the office helps young researchers develop useful skills, such as the ability to clearly communicate scientific ideas and to write a competitive grant application.  The NHLBI Office of Education sponsors mentoring and training programs that are applicable to scientists at every level of their career, from high school students to tenure-track faculty.

Council was enthusiastic about the program and the efforts for recruiting and maintaining the participation of women and minorities.  Dr. Geller added that evaluation criteria and tracking measures would be put in place in the future.

Cardiovascular Applications of Real-Time MRI - Dr. Elliot McVeigh

Dr. Elliot McVeigh presented an overview of the research being conducted in the Laboratory of Cardiac Energetics (LCE).  This NHLBI intramural project specializes in the use of non-invasive technologies to follow physiological processes in humans and animals.  He spoke about the applications of real-time magnetic resonance imaging (rMRI) and showed how higher magnetic strength and more sophisticated processing methods are capable of producing continuous high-resolution images.  He showed examples of how clinicians are able to view the heart and lungs of a patient who is undergoing a stress test and also showed how a catheter and delivery fluid can be viewed as a doctor manipulates them. Real-time MRI technology allows doctors to make a diagnosis, measure baseline function, and monitor recovery after therapy with no invasive procedures. The LCE runs a dedicated cardiovascular MRI on the NIH campus and a second scanner at Suburban Hospital in Bethesda, MD.

Council was impressed with the newly developed technology and discussed potential applications.

COPR Report on Human Research Protections in Clinical Trials: A Public Perspective -

Ms. Rosemary Quigley

The NIH Director's Council of Public Representatives (COPR) last year released a report on Human Research Protections in Clinical Trials.  Ms. Rosemary Quigley, an Assistant Professor at the Center for Medical Ethics and Health Policy at the Baylor College of Medicine and a member of the COPR, provided an overview of the role of the Council at the NIH and her perspective of the COPR report on Human Research Protections in Clinical Trials.

The COPR was created as a Federal Advisory Committee in 1998 to advise the NIH Director on issues related to:

• public input and participation in NIH activities

• public input and participation in the NIH research priority setting process

• NIH outreach programs and efforts

The group meets twice a year and all of their meetings are open to the public.

The first report released by the COPR addresses issues and makes recommendations concerning patient protection in clinical research trials. The report addresses:

• informed consent

• availability and transparency of information

• institutional Review Boards

• conflicts of interest

• confidentiality and privacy

• enhanced public education and training

• additional suggested areas of research

Council discussed various objectives including the need to educate the public and stimulating interest in research activities.

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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 and intramural review.  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 2:00 p.m. Dr. Lenfant also reminded the Council members that they are Special Government Employees and are subject to departmental conduct regulations. 

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III.    BEA INITIATIVES

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Cardiovascular and Sleep-related Consequences in Temporomandibular Joint (TMJ) Disorders

OBJECTIVES:  To conduct epidemiological and clinical studies of sleep and cardiovascular outcomes in TMJ Disorders (TMJD), to study factors associated with upper airway collapsibility and impaired sleep in TMJD, and to elucidate the role of central pathways involved in TMJD- associated autonomic and motor responses affecting sleep and neuromuscular control of upper airway patency.

Council commented that the initiative was broad and needed sharper focus but that it might be worthy of further study.

2.  Cultural Competence Academic Award

OBJECTIVES:  The objective of this RFA is to sponsor the development of core curricula and other educational resources that will enhance physicians’ ability to deliver culturally sensitive health care to multi-cultural U.S. populations.

Council commented that this initiative which had been revised appeared to be stronger although implementation could be improved and there should be greater sensitivity to cultural differences.  The need to involve practicing physicians was also emphasized.

3.  Diagnostic Screening Test for Salt Sensitivity

OBJECTIVES:  This program announcement (PAR) invites grant applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) projects to develop a non-invasive or minimally invasive, rapid, and practical diagnostic test for salt sensitivity.  Ideally, such a test will correlate with long-term changes in blood pressure resulting from a high salt intake.  It must be feasible for use in the general population, both in terms of low cost and use on an out-patient basis.

Council commented that this initiative was exciting, useful and should be supported.

4.  Hematologic Sequelae of Diabetes

OBJECTIVES:  The objective of this initiative is to stimulate basic and clinical research on the hematologic changes occurring with diabetes that result in diabetic related cardiovascular complications.

Council was enthusiastic about this initiative and supported it.

5.  Improving Resuscitation Outcomes -- NHLBI Clinical Research Consortium

OBJECTIVES:  This initiative is to establish a consortium to conduct patient-oriented resuscitation research. This area of research requires the cooperation of investigators, hospitals, emergency medical services (EMS), and the local community to effectively identify, enroll, and treat patients who have experienced an out-of-hospital arrest (OHA), defined as the sudden onset of impending or actual cessation in oxygen delivery associated with profound circulatory compromise that is inadequate for the body’s needs.  The investigators, first responders, and community leaders will function cooperatively under one organizational structure in an effort to facilitate the efficient translation of promising experimental strategies into clinical practice.  Research activities will involve the design and conduct of phase I-III clinical studies of resuscitation strategies.  Training of young investigators will be encouraged as this core of well-established investigators provide a supportive environment for the developing new scientists.

Council noted that this field has been relatively stagnant and supported it enthusiastically although there were clear challenges such as the issue of informed consent.

6.  Long-term Control of Cardiovascular Function in Health and Disease: An Integrated Approach

OBJECTIVES:  This initiative is focused on understanding how heart and vascular function is coordinated in intact organisms over long periods of time and on identifying changes in long-term control that predispose to the onset or maintenance of cardiovascular (CV) diseases, such as hypertension, arrhythmias, and sudden cardiac death.  This solicitation is for Exploratory and Developmental Grants (R21) that concentrate on obtaining scientific data to act as the basis for future regular research project grant applications (R01).  This initiative focuses particularly on two CV diseases that are known to have significant central nervous system (CNS) involvement: hypertension and cardiac arrhythmias.

Council was very supportive of this initiative especially the involvement of neuroscience.

7.  Mechanisms of HIV-Related Cardiopulmonary and Hemostatic Complications

OBJECTIVES:  This initiative is to encourage innovative research on the roles of co-infections, immune factors, genetic predisposition, metabolic/energetic mechanisms, and neural and hypothalamic-pituitary-adrenal axis influences on HIV related-cardiopulmonary and hemostatic complications.  The ultimate goal is to provide a rational basis for prevention and therapy for the cardiopulmonary and hemostatic complications caused by HIV and its related-factors.

Council was more enthusiastic about this initiative than the BEA and felt that there was more opportunity for discovery in this area.

8.  Overweight and Obesity Prevention and Control at the Worksite

OBJECTIVES:  This initiative supports controlled trials which emphasize environmental approaches to obesity prevention at worksites.  It will test the effectiveness of worksite interventions for preventing or controlling overweight and obesity in adults.  While the literature provides evidence on the feasibility of worksite interventions, there is a lack of evidence from well conducted trials regarding the effectiveness of such interventions.  The importance and timeliness of this initiative are supported by the alarming rate of increase in obesity, the high economic costs of obesity, and the existence of viable intervention strategies at the worksite.

Council was more enthusiastic about this initiative than the BEA and thought that this was of high priority and an example of translational research.  Working with the environment was considered key and innovative approaches were encouraged.

9.  Protein Processing and Degradation in Heart, Lung, and Blood Diseases

OBJECTIVES:  Advances in both molecular tools and our understanding of molecular mechanisms associated with protein transport now make it possible to probe the molecular pathology of cardiovascular, pulmonary, and blood diseases associated with defective protein folding as a basis of these diseases.  The purpose of this initiative is to explore the protein folding and quality control pathways operative in cardiovascular, pulmonary, and blood diseases, leading to a better understanding of how these mechanisms contribute to the molecular pathogenesis of disease and development of novel therapeutic interventions.

Council supported this initiative enthusiastically and commented that it was ahead of its time.

10.  Recovery of Heart Function with Circulatory Assist

OBJECTIVES:  This initiative is intended to understand how the use of a circulatory assist device results in clinical recovery of heart function.  Ultimately this research could optimize myocardial functional recovery by elucidating mechanisms that lead to ventricular reverse remodeling during circulatory assist.  When cardiac function returns, the device could be safely removed.

Council strongly supported this initiative, which would bring an opportunity to prolong life, improve the quality of life, and define new strategies for treating heart failure.

11.  Retrovirus Epidemiology Donor Study (REDS)

OBJECTIVES:  The objectives of REDS are to conduct epidemiological, laboratory, and survey research on volunteer blood donors to ensure the safety and availability of the Nation’s blood supply.  This includes monitoring known blood-borne infectious agents, rapidly evaluating the impact of emerging pathogens, assessing the safety implications of changes in laboratory and/or blood donor screening protocols, and examining blood supply availability issues.

Council was very supportive of this initiative.

12.  Somatic Cell Therapy Processing Facilities

OBJECTIVES:  To establish centralized facilities for the development of novel cellular therapies which would aid investigators by providing support in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials.  The range of activities supported by these facilities will include, but not be limited to: primary ex vivo cell culture under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) conditions, high throughput cell sorting, expansion ex vivo of desired cell subsets, and genetic modification of cells ex vivo with genes that will allow subsequent cell expansion or elimination under pharmacologic control in vivo.

Council considered this initiative to be excellent and supported it.

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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.

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IV.     REVIEW OF APPLICATIONS

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The Council considered 756 applications requesting $979,607,768 in total direct costs.  The Council recommended 753 applications with total direct costs of $966,649,406. A summary of applications by activity code may be found in Attachment B.

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V.    INTRAMURAL REVIEW

The Council then reviewed reports prepared by the Board of Scientific Counselors, NHLBI which reviewed NHLBI Intramural laboratories during FY2002.

ADJOURNMENT

The meeting was adjourned at 9:00 a.m. on October 25, 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 12/09/02

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