NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
February 1, 2006

I. CALL TO ORDER AND OPENING REMARKS - Dr. Elizabeth G. Nabel

Dr. Elizabeth G. Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 221st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Dr. Nabel reminded the Council that February is American Heart Month and encouraged everyone to wear a Red Dress pin on National Wear Red Day (Friday, February 3rd ) to show support for women's heart health awareness.

Member Updates:

The following Council members were unable to attend the meeting:

• Dr. Gordon Bernard
• Dr. Jane Newburger
• Dr. Ngai Nguyen
• Dr. George Thomas
• Dr. Linda Van Horn
• Dr. Patricia Wahl

Dr. Nabel announced the selection of four new Council members:

• Victor J. Dzau, M.D., Chancellor for Health Affairs, School of Medicine, Duke University
• Helen H. Hobbs, M.D., Professor, Department of Molecular Genetics, University of Texas Southwestern Medical Center
• Joseph Loscalzo, M.D., Ph.D., Chairman, Department of Medicine, Brigham and Women's Hospital
• Jennie R. Joe, Ph.D., M.P.H., Director, Native American Research and Training Center, College of Medicine, University of Arizona

Staff Updates:

Dr. Nabel also announced three new staff appointments:

• Dr. Christopher O'Donnell as Senior Advisor to the Director for Genome Research. Dr. O'Donnell will continue to serve in his current position as Associate Director of the NHLBI-supported Framingham Heart Study in addition to assuming his new duties with the Institute.
• Ms. Sheila Pohl as Chief of Staff. Ms. Pohl has served the Institute for many years, most recently in dual roles as Assistant to the Director and Deputy Ethics Counselor.
• Ms. Nancy O'Hanlon as Deputy Ethics Counselor. Ms. O'Hanlon is currently the primary lawyer for ethics matters at the Defense Intelligence Agency.

Three additional staff appointments, pending administrative clearances, are expected to be finalized soon:

• Dr. Susan Shurin as Deputy Director of the NHLBI. Dr. Shurin is highly talented and experienced in academic medicine, university leadership, and management of complex organizations. She was Professor of Pediatrics and Oncology at Case Western Reserve University and Chief of Pediatric Hematology/Oncology at Rainbow Babies & Children's Hospital in Cleveland.

The Institute thanks Dr. Carl Roth for his service as Acting Deputy Director over the past year.

• Dr. Alan Michelson as Associate Director for Basic Research. Dr. Michelson comes to the NIH from the Division of Genetics in the Department of Medicine at the Brigham and Women's Hospital. A highly respected researcher—his current research focuses on an aspect of heart and muscle development in Drosophilia, Dr. Michelson has also helped lead the M.D./Ph.D. training program at Harvard Medical School.
• Dr. Michael Twery as Acting Director nominee of the National Center on Sleep Disorders Research (NCSDR), which is administered by the NHLBI. In addition to his new responsibilities, Dr. Twery will continue to manage the Institute's sleep research portfolio as he has done for the past decade.

The Institute thanks Dr. Carl Hunt for his leadership of the NCSDR.

The Institute is currently completing recruitment for the Associate Director for Research Informatics and Information Technology.

Guest Speaker:

• Dr. Paola Sebastiani, Department of Biostatistics, Boston University

Other Guests:

• Representatives of the Public Interest Organizations

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II. REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST - Dr. Elizabeth G. Nabel

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. Nabel 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 DIRECTOR - Dr. Elizabeth G. Nabel

Initiatives:

Dr. Nabel highlighted several recent Institute initiatives:

• An initiative for genome-wide association studies to identify genetic components that relate to heart, lung, and blood disorders is about to be released (See Notice of intent to release RFA).
• A Request for Proposals (RFP) for research to maximize the scientific value of the biologic specimens from the Women's Health Initiative research studies has been released.
• An RFP for large-scale genotyping of NHLBI cohorts is expected to be released soon.

The Institute has reviewed its policies for distribution of data from clinical trials and epidemiology studies, and released a Request for Information seeking comments on its proposed modifications. Dr. Nabel looks forward to receiving opinions and advice from Council members on these policies.

• The new NIH initiative for new investigators (K99/R00) was recently announced and NHLBI will participate.

Budget Report:

The NHLBI working budget for FY 2006 is $2.896 million, about $27 million less than the comparable figure in FY 2005. Although tight financial times are expected to persist over the next several years, the Institute is in relatively good budgetary condition due to its careful financial planning. Dr. Nabel expects the Institute to weather the current stringent times without the need for severe measures. However, as she explained in a recent letter to all NHLBI grantees, direct costs for noncompeting renewals of research project grants (RPGs) will be scaled back in FY 2006 to 97.65 percent of their committed levels. This reduction is being implemented across all the NIH Institutes. Dr. Nabel offered to speak with Council members about any financial concerns

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IV. HEART TRUTH CAMPAIGN UPDATE - Dr. Gregory Morosco and Ms. Terry Long

Dr. Gregory Morosco, Director, Office of Prevention, Education, and Control (OPEC), NHLBI, briefly reviewed the Institute's efforts to coordinate the translation and dissemination of research findings to health professionals, patients, and the public in order to provide public health benefits to the nation. The Heart Truth Campaign, a highly successful NHLBI-led outreach program, seeks to reach women with critical messages about heart disease.

Ms. Terry Long, Senior Manager for Health Communications and Information Science, OPEC, updated the Council on the achievements of The Heart Truth Campaign. Launched in September 2002, The Heart Truth targets women ages 40 - 60 years, seeking to increase their heart health awareness. Highlights of the program include the Red Dress symbol; the slogan "Heart Disease Doesn't Care What You Wear - It's the #1 Killer of Women;" many successful partnerships with corporations, non-profit organizations, media, and other government agencies; and over 150 events held in local communities across the U.S.

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V. REPORT ON THE PUBLIC INTEREST ORGANIZATIONS – Dr. Elizabeth Nabel

Dr. Nabel welcomed members from the Public Interest Organizations (PIO) attending Council. Ms. Hoxi Jones reported on the meeting of the PIO held the previous day, January 31, 2006. Ms. Jones commented that the members appreciated the presentation by Dr. Zerhouni, Director of the National Institutes of Health, also appreciated the presentations by Dr. Peterson, Dr. Roth, Dr. Harvey, and Carl Weixler. In general this is an excellent forum to bring together the Institute and the community in a partnership capacity. Mr. Carl Weixler of the Hemophilia Federation of American appreciated the efforts on behalf of NHLBI staff to hear and act upon concerns. Dr.  Eddie Glenn-Bryand also expressed appreciation for the Institute’s efforts.

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VI. Genetic Dissection of Complex TR – Dr. Paolo Sebastiani

Dr. Paolo Sebastiani, Associate Professor in the Department of Biostatistics and Adjunct Associate Professor in the Bioinformatics Program, Boston University School of Public Health, discussed her research about complex genetic diseases, which are caused by the interplay of several genes and which can be modulated by exposure to environmental factors. Using an analytical approach based on Bayesian networks, Dr. Sebastiani and her research team have investigated the genetic basis of stroke in sickle cell disease (SCD) patients. They developed a model to identify SCD patients at risk of stroke, based on their genetic profiles. Using data from a large cohort of patients, they have also defined a score of SCD severity and associated it with single nucleotide polymorphisms (SNPs - variations in the DNA sequence) in candidate genes. Dr. Sebastiani now plans to expand her research by performing genome-wide studies, as well as by focusing on specific population groups.

Council members were enthusiastic about Dr. Sebastiani's research. Dr. Nabel emphasized the need to have guidelines in place for the many genome-wide association studies that are on the immediate horizon. She said the first step is the development of data access policies.

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VII. GENERAL RECOMMENDATIONS – Dr. Deborah Beebe

Dr. Beebe, Director of the Division of Extramural Affairs, reviewed the general recommendations with Council. The general recommendations are the authorities delegated to Institute staff to be able to conduct business between Council meetings. Several revisions were approved and they are incorporated in the revised document which is included as Attachment B.

CLOSED PORTION

This portion of the meeting was closed to the public in accordance with the determination that it concerned 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.

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VIII. REVIEW OF APPLICATIONS

The Council considered 1,151 applications requesting $1,710,764,343 in total direct costs. The Council recommended 1,150 applications with total direct costs of $1,702,304,890. A summary of applications by activity code may be found in Attachment C.

ADJOURNMENT

The meeting was adjourned at 2:30 p.m. on February 1, 2006.

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