NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
February 6, 2003

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

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Dr. Claude Lenfant opened the meeting and welcomed the Council members to the 209th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). He reminded Council that February is American Heart Month. This year’s theme is "Get Hands On And Help Save A Life." The Institute is promoting cardiopulmonary resuscitation (CPR) and encouraging support for community automatic external defibrillators (AED).

New Council Members

Dr. Lenfant introduced the new Council members whose terms began on November 1, 2002. They are:         Dr. Gordon Bernard who is the Director of the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt School of Medicine in Tennessee; Dr. Maria Costanzo, who is Medical Director of the Edward Hospital Center for Advanced Heart Failure; Dr. Kim Eagle, who could not attend the meeting, is the Albion Walter Hewlett Professor of Internal Medicine of the Health System Cardiovascular Center at the University of Michigan, as well as, the Chief of Clinical Cardiology at the School of Medicine; Dr. Francis Henderson who is Professor and Dean of the Alcorn State University School of Nursing in Natchez, Mississippi; and Dr. Ngai Nguyen, who is an Assistant Clinical Professor of Medicine at the University of California, San Francisco.

Drs. Alcalay, Byrnes, Drazen, Eagle Lipscomb, Mason, Toy, and Steele were unable to attend the Council meeting.

Special Guests

Dr. Lenfant announced that Dr. Elias Zerhouni, the Director of the National Institutes of Health, will address Council today. Also, representatives from the Public Interest Organizations are guests at the meeting. This group shares public views on specific issues with the Institute, and meets with senior staff as well as Council representatives to discuss how the organizations and the Institute can better support research, disseminate public information, and promote high quality clinical studies.

Personnel Announcements

Dr. Barbara Alving has been named as the Director of the Women’s Health Initiative, which is coordinated by the Institute. Dr. Alving is also the Deputy Director of the Institute.

Dr. Wendy Baldwin, who was the Deputy Director for Extramural Research, NIH, has been appointed as the Vice President for Research at the University of Kentucky. Dr. Belinda Seto is serving as Acting Deputy Director for Extramural Research.

New Publications

New publications included: 1) a copy of the latest issue of the Institute’s public interest newsletter "FYI from the NHLBI," 2) a pamphlet entitled "The Heart Truth for Women," 3) the publication "The Healthy Heart Book for Women," 4) three Fact Sheets on Heart Disease in Women, 5) a document which reports how the NHLBI invested the Fiscal Year (FY) 2002 budget increase, and 6) the NHLBI FY 2002 Fact Book.

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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. 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.

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III.    REPORT OF THE DIRECTOR - Dr. Claude Lenfant

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Dr. Lenfant presented information on the NIH budget. There is a $549 million dollar increase in FY 2004 over FY 2003 with a 7.5% increase in research. There is a 116% increase for biodefense research. The number of Research Project Grants (RPGs) will increase by 344. Grants will be fully funded at the recommended amounts, which has always been the policy at NHLBI. The average cost of a grant has increased by 2.7% in aggregate. Dr. Lenfant commented that Council must exercise its authority to carefully consider expensive grants. There was a transfer of $15 million of the NHLBI budget to the National Institute for Bioimaging and Biotechnology (NIBIB) as required by Congress. The government is still operating on a continuing resolution until February 7. For NHLBI the FY 2004 Presidential budget is $106 million over the FY 2003 Presidential budget (a 3.8% increase). Research grants are $85 million over the FY 2003 budget (a 4.6% increase). The total extramural budget is $101 million over FY 2003 (a 4% increase). The number of competing grants will increase by 68, but only if costs are contained at a 2.7% average cost increase. SBIR grants are mandated at 2.8% of the budget. New competing grants will increase to 748 in FY 2004 and competing renewals will increase to 345. In response to a question, Dr. Lenfant indicated that the NIH Director distributes the NIH budget among the various institutes.

Dr. Lenfant led a discussion on the letter he sent to Council dated January 15, 2003 concerning the conduct and oversight of clinical research. Enclosed was a draft letter which is to be sent to investigators who are involved in clinical research requesting information. Council commented that the information requested needed to be very specific to obtain consistent data. In response to a question on ethnic classifications, Dr. Roth stated that the data is based on self-identification. In response to a question regarding the need for an Institutional Business Official’s signature on investigators’ recruitment plans, Dr. Manolio stated that the institution conducting the research, not the investigator him/herself, is held responsible for recruiting the number of people which is specified in the study. Dr. Lenfant said that the comments of Council would be carefully considered.

IV.   INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS (T32) - Dr. Carl Roth  

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Dr. Carl Roth reported on the T32 training grants which show a marked increase in cost. This is attributed to increases in postdoctoral stipends that were mandated by Congress. The data also show that 15% of the training grants are currently over $500K. According to the NIH/NHLBI policy, these grants will have to request permission from the Institute to submit competing renewal applications. In addition, according to NHLBI policy, applications that are over $500K are not allowed a second amended application (A2). The data also show that many of the more expensive grants have been in existence for 20-30 years and most have had several Principal Investigators (PI).

Dr. Lenfant emphasized that the cost of these grants is increasing faster than the increase in the budget and that many of the grants are of long duration. These data indicate that fewer awards may be made and fewer new grants would be awarded. Council was asked to consider various options to deal with these issues. These include putting a cap on the dollars or the number of slots for T32s as well as issuing a new grant number for long standing programs where the PI has changed. If adopted such changes would not go into effect until the May 10, 2004 receipt date (FY05). Several Council members expressed the opinion that awards should continue to be made on the basis of scientific merit and that it would be important to establish the priority of T32s in relation to other grants. Dr. Lenfant reiterated that the budget for training is fixed and could not be altered. He then asked Council to think about the issue and that a subgroup of Council might be convened to study the problem more extensively for consideration at the May 2003 meeting. Dr. Lenfant emphasized that it would be important to ensure opportunities for new training programs in the extramural community.

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V.    PERSPECTIVE OF THE NIH - Dr. Elias Zerhouni  

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Dr. Elias Zerhouni, Director of the National Institutes of Health, addressed the Council and began the discussion by thanking those who serve on the advisory committees of NIH. There are 21,000 people who are involved in this very important exercise. He then discussed the effort at NIH to deal with the post-doubling budget. He described the roadmap exercise: identifying the new areas of science that were beyond the reach of any one institute, identifying the roadblocks to adapting to the new research environment, and identifying the knowledge gaps that cannot be addressed due to the current organization. Three themes have emerged: the need to explore new pathways to discovery (for example, a function like cell signaling which will involve complex multi-disciplinary work), the need to re-engineer the clinical research enterprise to enable maximum capacity for translation of basic research into clinical treatment, and finally the need to evaluate the training programs from the point of view of a future model of research needs and to prevent the decline in young investigators. Dr. Zerhouni discussed the NIH FY 2003 budget, which includes many non-recurring items such as biodefense construction, construction of the Clinical Center, and the procurement for vaccines. He stated that there is a 7.5% increase for research and a 4.5% for non-biodefense research. In response to a question on training, Dr. Zerhouni noted the problem with investigators dropping out of research. He also emphasized the need for multi-disciplinary training. In response to a question on training for physician-scientists, Dr. Zerhouni noted that there was no discipline for clinical research and that the pool of physician-scientists needed to increase despite the increased burden of clinical research. Council also discussed the issue of biodefense and Dr. Zerhouni explained how the entire civilian biomedical research enterprise will participate. Dr. Lenfant thanked Dr. Zerhouni for speaking to Council.

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VI.    PUBLIC INTEREST ORGANIZATION MEETING  

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Dr. Lenfant asked those Council members who had attended the Public Interest Organization (PIO) meeting to give their impression of the meeting. The attendees were generally impressed with the meeting which they described as enriching. They noted the courage of the groups to do something positive in the face of overwhelming odds. There were innovative ideas such as conferences to bring physicians together with patients and informing patients of advocacy groups and foundations. Council also thought patients should be better informed about NIH and about clinical trials. Council noted that the groups were helping each other and providing mentorship. Various advocacy group members spoke individually praising the meeting and thanking the NHLBI for the opportunity to come together and for empowering all the groups. There was enthusiasm for using all resources available to help NHLBI promote their work. There were 88 groups invited and 49 groups attended. Dr. Lenfant remarked that NHLBI would develop an educational process to inform the public as well as practitioners about clinical trials. Dr. Zerhouni is considering creating a clinical research corps calling on the practicing physician base to contribute to clinical trials. The ALLHAT trial was a good example of how to bring together practicing physicians to participate in a trial through different health care organizations.

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VII.    REPORT ON THE INCLUSION OF WOMEN AND MINORITIES IN CLINICAL STUDIES - Dr. Carl Roth 

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Dr. Roth presented the biennual report on the Inclusion of Women and Minorities in Clinical Studies. This is a directive from the NIH Revitalization Act of 1993, which specified that each institute "prepare biennial reports describing the manner in which the Institute has complied with this section." The decision by the NIH was to issue a consolidated report prepared by the Office of Research on Women’s Health. To accomplish this, each HSA must evaluate a relevant project for appropriate representation of women and minorities. If there are any concerns, they are discussed with the applicant. No application with unresolved concerns will be brought to Council. Dr. Roth then presented the data which demonstrated that NHLBI complied with the policy. The data were presented both with the Women’s Health Initiative and without it and the 2000 Census data were included for comparison. The data show adequate participation with respect to American Indian/Alaskan Native, Asian/Pacific Islander, Black (non-Hispanic), Hispanic, and White (non-Hispanic). It was noted that recruitment efforts need to improve to provide better inclusion of Hispanics. Council concurred with the report. 

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VIII.    SPARK II UPDATE - Dr. Claude Lenfant  

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Dr. Lenfant described the SPARK I process, which was initated to plan for the doubling of the NIH budget and to capitalize on that investment. A small group of recognized experts in heart, lung, and blood research was convened to outline a plan. This was followed by a meeting of representatives of the professional organizations to plan a vision for NHLBI in the next four to five years. As a result, of the SPARK I process the Institute solicited new programs worth approximately $500 million.

SPARK II was initiated to determine research priorities for NHLBI. A small group of experts was convened in October 2002. The second meeting held January 20, 2003, involved representatives from the professional societies. Council was also invited to attend. Dr. Lenfant asked Council members who attended the SPARK II meeting for their impressions. Council noted that multi-disciplinary programs were emphasized as well as translational research especially with regard to genomics and proteomics research. Virtual centers were also discussed for future programs. In addition the application of proven successful interventions to the general population was considered to be vital. In general, Council thought that the participants and the format were excellent.

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IX.  GENERAL RECOMMENDATIONS ON COUNCIL DELEGATED AUTHORITIES  -           Dr. Deborah Beebe

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Dr. Beebe presented the General Recommendation on Council delegated authorities. There were no changes in the recommendations and they were unanimously approved.

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).

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.

X. REVIEW OF APPLICATIONS

The Council considered 965 applications requesting $1,165,673,041 in total direct costs. The Council recommended 963 applications with total direct costs of $1,120,911,978. A summary of applications by activity code may be found in Attachment B. 

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ADJOURNMENT

The meeting was adjourned at 2:45 p.m. on February 6, 2003.

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 3/28/03