NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

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Dr. Barbara Alving opened the meeting and welcomed the Council members to the 211th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Management Change

Dr. Claude Lenfant retired as Director of the Institute as of August 30. He will have Emeritus status during the next year. Dr. Alving has assumed the position of Acting Director during the search and selection process of finding a new Director. Dr. Lawrence Friedman has agreed to serve as Acting Deputy Director during this time.

Sickle Cell Disease and National Cholesterol Education Month

September is both Sickle Cell Disease Month and National Cholesterol Education Month. The same theme as last year has been continued "Know your Cholesterol Numbers- Know your Risk". The Institute continues to provide materials, including articles, recipes, charts, and ideas to help educate the public to learn about their cholesterol numbers and how to improve them.

Member Updates

Dr. Robert Jesse will replace Dr. Pamela Steele as the ex officio member from the Department of Veterans Affairs. Dr. Steele has resigned as an Ex Officio member of the council due to reassignment. She has represented the Department of Veteran Affairs for more than eight years. Dr. Jesse is the Chief of Cardiology at the Richmond Veterans Administration Medical Center and Professor at the Medical College of Virginia, Virginia Commonwealth University. He will attend the October Council meeting.

Drs. Alcalay, Drazen and Eagle and Mr. Meisel did not attend the meeting.

Guests

Dr. Alving introduced the guest speaker, Dr. David White who is Director of the Sleep Disorders Program at the Brigham and Women’s Hospital in Boston.

New Publications

Publications provided included the Public Interest Newsletter from NHLBI.

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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 8:30 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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Dr. Roth presented estimated figures for the FY 2004 budget as well as the figures for the revised President’s Budget, and the House and Senate Allowance for FY 2004. The President’s Budget and the House Allowance are the same ($2.868 billion) and reflect a 2.7% increase over FY 2003 while the Senate Allowance ($2.897 billion) shows a 3.8% increase over FY 2003. The number of competing research project grants would increase to 4,261 for the President’s budget and the House allowance and 4,263 for the Senate allowance. The number of competing awards has increased from 800 in 1997 to a projected number of 1076 in 2004.

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Dr. Roth gave an overview of Dr. Lenfant’s career and some of the many accomplishments that were made during Dr. Lenfant’s leadership of the Institute. Dr. Lenfant obtained his Medical Degree at the University of Paris in 1956 and was working in the laboratory of cardiac surgery when he came to the University of Buffalo to study cardiac and circulatory diseases. He rose to the level of Professor of Medicine at the University of Washington in Seattle where he was asked by then-Director of the Heart and Lung Institute Dr. Theodore Cooper to provide comments on the direction of lung research. He was then recruited by Dr. Cooper and became the Director of the Division of Lung Diseases at the Heart and Lung Institute. In 1982 he became the tenth director of the National Heart, Lung, and Blood Institute where he has been one of been the longest running directors at NHLBI (second longest at NIH) Among the multiple programs initiated by the Institute during his tenure were the Programs of Excellence in Molecular Biology and the recent Proteomics Initiative. Numerous clinical trials were conducted during this time including the Lung Health Study, the Multi-Center Study of Hydroxyurea, and most recently the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Observational studies were also conducted and more recently multiple clinical trial networks have been established. A prominent interest which Dr. Lenfant promoted was the Institute’s Education Programs including programs on High Blood Pressure, Cholesterol, Smoking, National Blood Resources, Asthma, Obesity, Heart Attacks, Sleep, and the Heart Disease and Women. Dr. Lenfant sought to insure that the knowledge gained from research was translated into the practice of medicine through these programs.

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Dr. David White discussed the 2003 National Sleep Disorders Research Plan. Its nine priorities include:

• sleep neurobiology and the function of sleep
• the adenosine hypothesis (what controls sleep)
• the impact of redundant or restricted sleep (behavioral, neurobiological, systems physiology, safety)
• understanding the processes leading to sleep disorders (insomnia, sleep apnea)
• new treatments for sleep disorders
• relation between the process of sleep and the progression of diseases of neural and non-neural tissue
• sleep education
• incorporate new technology and methodologies
• attract and train new investigators

Council was enthusiastic about the recommendations and commented on the timeliness of the issue as well as the interdisciplinary nature of the research which involves basic science, neurobiology and pulmonology, and cardiology.

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Dr. John Thomas outlined the progress in stem cell research to date. In August 2001 the Cell-Based Therapy Special Interest Group was formed in the Institute to address stem-cell based therapy for heart, lung, blood, and sleep disorders, to track embryonic stem cell grants and to work on a strategic plan for new cell-based therapy. In May 2002 a meeting was held on Regenerative and Reparative Medicine to develop a strong basic research program in stem cell biology and cell therapy. Several initiatives were released as Program Announcements, as Request for Applications (RFAs), or as solicitations for initiatives to supplements ongoing research. In August 2002 the NIH Stem Cell Task Force was formed, based on a meeting with Secretary Thompson and Dr. Zerhouni to advise the NIH Director, to identify resources and to advance stem cell research. New educational opportunities were devised to provide training on Embryonic Stem Cells (ES) (T15s, career enhancement, and established investigator leadership awards). A unit on Embryonic Stem Cell Research was created within NIH Intramural research and the unit is advised by an expert panel of scientists. Twelve cell lines are currently available for use; they are listed on the NIH web site. Other NHLBI resources available for ES research include the Programs of Excellence in Gene Therapy, the Programs of Genomic Applications, the Proteomics Initiative, and the NHLBI Somatic Cell Processing Centers.

Dr. Henslee-Downey discussed the new Specialized Centers of Clinically Oriented Research (SCCOR ) on the Development of Cell-Based Therapies which replaces the Stem Cell Specialized Centers of Research (SCOR) program. This would be a trans-divisional initiative with funding currently planed for FY 2005.

Council commented that the lung community may not be ready for clinical trials in this field.

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Dr. Kington, Deputy Director of NIH, discussed the Institute of Medicine Report enhancing the vitality of the National Institutes of Health organization and change to meet new challenges. The Report addressed the structure of NIH and the proliferation of Institutes and centers. The Report urged the development of a standardized process for creating a new institute and suggested that several institutes be merged such as the National Human Genome Institute with National Institute of General Medical Sciences and the National Institute of Alcohol Abuse and Alcoholism with the National Institute of Drug Abuse. The Report emphasized the importance of appointing scientific experts to the Institute advisory councils as well as making NIH decision-making processes more transparent. Since legislation for re-authorizing the NIH is forthcoming, the IOM Report will form a framework for the related hearings. One of the areas of emphasis was clinical research at the NIH both extramural (NCRR) and Intramural (Clinical Center). The importance of funding innovative high-risk research was also emphasized.

Council commented that NIH seems to respond quickly in national emergencies such as the SARS epidemic and has traditionally been buffered against political changes. In addition, the issue of innovative research has been a long-standing problem due to the conservative nature of the peer review system. However, a pilot program to fund investigators to do innovative research is being developed by Drs. Strauss and Ehrenfeld and will begin next fall. Similarly a blue-ribbon task force is addressing intramural clinical research. The NIH Roadmap initiative is addressing partnerships between public and private sources.

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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).

Procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations were discussed. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications that raised a potential conflict of interest, whether real or apparent. Members were asked to sign a statement to this effect.

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The Council considered 210 applications requesting $ 400,761,410 in total direct costs. The Council recommended 210 applications with total direct costs of $ 400,236,410. A summary of applications by activity code may be found in Attachment B.

The meeting was adjourned at 2:00 p.m. on September 4, 2003.

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

Barbara Alving, M.D.

Acting Director

National Heart, Lung, and Blood Advisory Council

on October 16, 2003