NATIONAL HEART,
LUNG, AND BLOOD ADVISORY COUNCIL
MEETING MINUTES
September 6,
2001
I. CALL TO ORDER
AND OPENING REMARKS – Dr. Claude Lenfant
Dr. Claude Lenfant opened the meeting and welcomed the
Council to the 203rd meeting of the National Heart, Lung, and Blood Advisory
Council (NHLBAC).
September was noted as sickle cell disease month as
well as cholesterol education month. For cholesterol education, this
year’s theme highlights the importance of having your cholesterol measured
and knowing your risk of developing heart disease.
Member Updates
Drs. Drazen and Martin could not attend the Council
meeting.
Guests
Dr. Lenfant welcomed a number of guests including Dr.
Robert Califf who is a Professor in the Department of Medicine Division of
Cardiology at Duke University, Dr. Beverly Mitchell who is a Professor in the
Division of Hematology/Oncology at the University of North Carolina, Dr. Gary
Gibbons who is Director of the Cardiovascular Institute at the Morehouse School
of Medicine, and Dr. Raynard Kington who is the Associate Director for
Behavioral and Social Science Research at NIH in the Office of the NIH
Director.
BEA Meeting
Council members were invited to the Board of
Extramural Advisors working group meeting at the end of the month. The
results of that meeting will be presented at the October Council.
October Meeting
The October Council is scheduled for October 18-19.
Several Council members will be retiring including Drs.
Johnson, Martin, Whelton, and Ms. Polite. In addition, representatives of the
various NHLBI advisory and review committees will attend the open session.
There are a number of important matters to be
discussed at October Council. First, the Specialized Centers of Research (SCOR)
program, which was established in the early 1970s, is currently being
reassessed by a committee of Institute staff. The issue is that the
clinical research has not met expectations. A report of the
committee’s findings and recommendations will be presented at the October
Council.
Second, the concept of a skill development core in
large programs was discussed at February Council and these recommendations will
be presented at October Council.
Third, the reports of two task forces, one on
pediatric cardiology and one on prevention of cardiovascular disease, will be
presented.
Personnel Announcements
Dr. Barbara Alving has been appointed as the Deputy
Director of the Institute. Dr. Alving is currently the Director of the
Division of Blood Diseases and Resources and she will resign that position when
she moves in to her new office. At that time, Dr. Charles Peterson will be the
Acting Director of the Blood Division until a permanent Director is
selected.
Secretary’s Visit
The Secretary of the Department of Health and Human
Services, Tommy G. Thompson, spent the week of August 20th visiting
the NIH, and the NHLBI had the opportunity to inform the Secretary about
several of the Institute’s programs. The Office of Prevention, Education,
and Control gave a presentation on the National High Blood Pressure Education
Program and the Cholesterol Education Program. These programs represent a
partnership of many professional public health and commuity organizations to
address two major public health challenges. The Secretary also toured the
NHLBI Bone Marrow Unit in the Clinical Center with Dr. Nabel as well as the
Magnetic Resonance Imaging Stroke Center at Suburban Hospital with Drs. Nabel
and Balaban.
New Publications
Dr. Lenfant noted that there were several information
items for the Council. These included a report of the Clinical Trials
Workshop, a report of the Workshop on Minority Recruitment and Retention, the
Executive Summary of the report from the Academy of Sciences on Behavioral and
Social Sciences, and an update on Embryonic Stem Cells. Also included in
the briefing book was the second issue of "FYI from the NHLBI," which was
initiated in response to requests by the participants of the first public
interest group meeting last year, and minutes from the May Council
meeting.
II.
REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST – Dr.Claude
Lenfant
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 2:00 p.m.
Dr. Lenfant also reminded the Council members that they are Special Government
Employees and are subject to departmental conduct regulations.
III. PRESENTATIONS
Recommendations to the NHLBI from the Workshop on
Clinical Trials
Dr. Robert Califf from Duke University Medical Center
gave a presentation on the NHLBI-sponsored workshop to improve the
effectiveness and efficiency of NHLBI-supported clinical studies. One of
the fundamental observations of the workshop was that basic science has brought
about a significant number of therapeutic options as well as diagnostic
technology at an extremely rapid pace. The workshop underscored the need
to understand diagnostics, therapeutics, and prevention in children and the
elderly which are two populations that have been ignored for the most part in
clinical research. There is also a demonstrated need to link clinical
trial findings to delivery especially when dealing with under-treated minority
populations.
At the health care centers where clinical research is
done, it is no longer possible to subsidize research from the clinical
operations which was a widespread practice of the past.
In addition the scrutiny on ethics has created a
situation in which there is true competition between writing the science in a
protocol and conducting the protocol. Research must deal with legalistic
issues both in terms of financial arrangements and ethical requirements.
Patients have evolved from being passive recipients to being active consumers
of health care and research.
There is a vast amount of data being accumulated as a
result of NHLBI-funded research by the NHLBI and better use should be made of
these data. There also needs to be a refinement of the mechanisms to
facilitate access to existing data sets. Rules should be established to
allow people to share their data without sacrificing rights to ownership.
Better sharing of data sets among agencies and grantees would be useful and the
use of registries was recommended especially in the areas of rapidly evolving
technology.
In addition it would be beneficial to include
interventional components within epidemiologic studies. The workshop also
recognized the need for a systematic approach to follow-up on clinical
trials. There needs to be more support for methodological work on how to
do clinical trials better and to understand the role of observational data in
the context of clinical trials. The idea of networks to increase
efficiency was promoted. Studies with multiple interventions could be addressed
by trials of a similar structure using similar operations and data collection
methods especially for short-term investigations. It was recognized that
networks might provide an opportunity for major public/private partnership
efforts. It was felt that additional focus would help the co-funding of
studies of interventions by both the public and the private sector.
There was a feeling that there should be an effort
made to develop more standard clinical nomenclature and more uniform operations
manuals. Common information technology platforms were recommended such as
training investigators over the Internet and the potential for using the
Internet to conduct IRB meetings.
Developing pools of investigators who have common
training in good clinical practice and a common operational approach was given
considerable importance. There was a question as to whether the NHLBI
might be the appropriate organization to certify cardiovascular, lung and blood
investigators as having received the necessary level of training.
An annual meeting in each major disease area was
recommended to review research priorities and to review the output of major
studies and clinical trials. The nomenclature would be reviewed and
updated to increase efficiency in terms of how data are collected from
different trials. This could be also be a focal point for training new
investigators and updating current investigators.
Another key element in terms of gaining efficiency
would be to reduce the time for protocol development by allowing a smaller
group to meet and decide on the protocol. There is a need for pilot
studies to demonstrate that an approach is feasible. This might be a way
to encourage people to be entrepreneurial without fear of losing their
funding. Ongoing networks might play a major role since multiple pilots
could be tested.
An issue that was thought to be of urgent importance
was working with the Office of Human Research Protection (OHRP) to develop a
common understanding of how to deal with the increasing demands for
investigators to meet ethical standards in research protocols. This might
include the ethical review of centrally accessed information and an effective
auditing system.
The need for a major review of the cost of conducting
clinical trials was recommended so that there would be a standard for payment
that would allow investigators to avoid concern about the prohibitive costs of
doing clinical research. A great need has developed for working across
institutes to increase efficiency in researching chronic diseases. It may
be possible to explore working with the Veterans Affairs (VA) cooperative group
which funds many trials that are smaller. There was a suggestion to work
with the newly named organization, Centers for Medicare and Medicaid Services
(CMS), formally Health Care Financing Administration (HCFA), to ensure that the
President's directive on reimbursement for clinical trials would be as smooth
as possible.
Clinical studies are considered deficient in terms of
enrollment of the elderly. There was a feeling that this might even merit the
creation of a specific office to ensure that inclusion of elderly patients is
improved.
Working with the medical products industry was
suggested in terms of public/private partnership. Assistance from NHLBI
would be desirable in dealing with difficult negotiations that often occur over
ownership of data and what co-funding actually means in terms of rights and
prerogatives of the different parties. Increased involvement of managed health
care was also recommended.
Finally, maximizing the return on the research
investment through continued efforts to plan ancillary studies to ongoing
clinical trials was lauded. An equivalent program is needed to fund
methologic research and statistical methods in the conduct of clinical
trials. Council was apprised that there is a current initiative
("Innovative Studies") with a set aside of money for such research.
Council agreed with the recommendations of the
workshop. There was discussion as to whether NHLBI should consider larger
studies either observational or experimental in countries overseas.
However, there are ethical implications of doing research in foreign
countries. Council concurred that it would be important to determine how
to do trials in the U.S. less expensively. The goal would be to create
communities of investigators who work more efficiently together. A
proactive approach would be very useful for both ethical considerations as well
as integration and sharing of data sets. Council also wished to reinforce
the interagency and inter-institutional cooperation to improve
efficiency. A suggestion was made to legislate all third-party payers
involved.
Dr. Lenfant added that it may not be possible to do as
many studies as we would like because the costs are fairly significant.
There is also another issue with Medicare which is a co-payment. NHLBI is
negotiating with HCFA at this point for a waiver. Basically medical care
is offered for free as part of a clinical trial and the segment that the
patient is responsible for under Medicare must be collected from the patient.
Dr. Lenfant pointed out NHLBI was the first institute to cosponsor a clinical
trial with HCFA. Dr. Gail Weinmann explained that HCFA Medicare approached
NHLBI about doing a trial on lung volume reduction surgery because they wanted
information in their beneficiary population about the effectiveness of the
intervention. This was a new model. HCFA has been paying the
clinical services that are allowed under statute and the NHLBI has been paying
for the administrative costs, particularly for the coordinating center and the
data analysis. There are many areas that needed to be worked out and the
co-payment was one of them. The model has been very useful but it does
restrict the population to the Medicare beneficiary population. One of
the things that made this study possible was that Medicare paid for lung volume
reduction surgery under a conditional coverage policy which meant that it is a
covered service as long as it is administered within the context of the
clinical study. It allowed them to cover a procedure while collecting
data.
Dr. Lenfant told the Council that at the next Council
(October) the addition of a skill development core within SCOR programs,
clinical trials, and networks would be discussed. This would greatly
augment the training of clinical investigators.
There was a discussion of whether or not multi-site
clinical trials would constitute a separate centralized Institute Review Board
(IRB) with a representative or more than one representative from each of the
institutions' IRBs. This IRB would do approvals for the entire project. It was
recognized that in most instances each institution has a very strong desire to
be responsible for its own activities. Such an IRB might work if there
were connections via Internet or satellite to the local IRBs. The local
IRBs could hear the discussion of the centralized IRB and use this as a basis
for their subsequent deliberations. Most local IRBs don't have the
statistical or scientific expertise and a centralized IRB could contribute in
this regard.
Council also emphasized the need for investment in
bioinformatics. Council stressed investment in image analysis because it
is central to a lot of the issues that have to do with large scale trials as
well as with genomics.
Council also advised evaluating these recommendations
as they are implemented to see how well the stated goals are being
achieved.
IV. Report of the NHLBI Workshop on Recruitment and Retention of African
Americans Hispanic Americans, and Native Americans in Scientific Research
Careers
Dr. Charles Peterson presented a summary of the recent
Workshop on Recruitment and Retention of African Americans, Hispanic Americans,
and Native Americans in Scientific Research Careers Relevant to Heart, Lung,
Blood, and Sleep Disorders -- What Works, What Doesn’t, and What Should We
Do? The recommendations, which are now available online, included the
following: removing barriers that hinder interactions with the NHLBI; creating
new funding mechanisms; improving outreach campaigns; fostering collaborations
between "research intensive" universities and local schools; and improving the
mentoring environment for minorities.
Dr. Beverly Mitchell, University of North Carolina at
Chapel Hill (UNC-CH) and President of the American Society of Hematology,
described the importance of maintaining a "pipeline" of eligible students who
are interested in careers in science by reaching out to younger students
(K-12). She also addressed the importance of mentoring and how to get
more effective mentors by increasing funding. It is also important to
retain trainees in academic careers. Developing a network of minority
trainees might serve to enhance interest in academic careers. These
issues need to be addressed at all levels: the institute, the institution, and
program leadership.
Dr. Gary Gibbons, Director of the Cardiovascular
Research Institute at Morehouse School of Medicine, talked about the need for
the NHLBI to attract students at historically black colleges and
universities.
Following Dr. Gibbons presentation, NHLBAC members
participated in a discussion of how the programs at Morehouse and other
universities can be used as models for other programs to recruit and retain
minority scientists. Outreach campaigns to attract more minorities is
considered vital. One issue concerns orientation of programs to cultural
sensitivity. Other issues include the need to reward mentors and the need
to increase or improve the pipeline of qualified candidates. Incentives such as
providing a percentage salary bonus for mentors who have proven track records
during the review of training grant renewals were discussed. Developing a merit
program or scholarly support to reward mentors was another idea
presented. A suggestion was made to extend the loan repayment program to
minority students who are engaged in research programs. Ultimately,
holding the various training programs accountable for accomplishing their
recruitment plan goal is crucial. Another suggestion was to have an office to
monitor the progress of minority investigators.
V.
Overview of NHLBI Office of Prevention, Education, and Control Activities
Dr. Gregory Morosco, OPEC Director, provided an
overview of some of the education and outreach activities sponsored by the
NHLBI. He shared a videotape, which promotes the NHLBI Heathy People 2010
Gateway (http://nhlbihin.nhlbi.nih.gov) and the NHLBI Health Information
Network, the Institute’s digital link to medical and public health
professionals who have joined to receive information periodically by e-mail
from NHLBI about its latest key research findings, clinical advisories,
programs, and educational materials. The goal of the New Healthy People
2010 is to eliminate not just reduce health disparities by the year 2010.
Ms. Terry Long, OPEC Senior Manager for Health
Communications and Information Science described a new public education
campaign on heart attack awareness–"Act in Time to Heart Attack Signs,"
which was to be launched on September 10 at an NHLBI press conference
cosponsored by the American Heart Association. Other partners in this OPEC
performance project include the American Red Cross and the National Council on
Aging. The campaign will target the general public with special emphasis
on older adults, women, minority groups, and communities at risk. The
campaign will further target people who have been released from emergency
departments after having been ruled out for a heart attack, or discharged from
the hospital with a diagnosis of coronary heart disease.
Garfield the Cat made a surprise visit to Council to
help Ms. Sue Rogus, Sleep Education Activities Coordinator, describe the
NHLBI’s multiyear effort to educate children and their parents about the
importance of sleep. Ms. Rogus showed an animated, 30-second TV public
service announcement and other educational and promotional materials, and she
described partnerships including school districts and the National Association
of Elementary School Principals. A special Web page has been developed to reach
children, parents, and teachers with the "Garfield Star Sleeper" messages and
materials at http://starsleep.nhlbi.nih.gov.
Dr. James Cleeman, National Cholesterol Education
Program (NCEP) Coordinator, described NHLBI activities for National Cholesterol
Education Month. This year’s theme, "Know Your Cholesterol
Numbers–Know Your Risk," highlight two main points of the new cholesterol
guidelines the "Third Report of the NCEP Expert Panel on Detection, Evaluation,
and Treatment of High Blood Cholesterol in Adults" (Adult Treatment Panel III,
or ATP III): the importance of having your cholesterol measured and knowing
your risk of developing heart disease.
Dr. Cleeman demonstrated several of the resources that
patients and physicians can use to calculate risk of having a heart attack and
to reduce that risk. The resources are available through the ATP III Web
page and in the online National Cholesterol Education Month Kit
Council was very supportive of the efforts on the part
of NHLBI to reduce health disparities. There was discussion as to both
the dissemination of information as well as the difficult task of modifying
behavior among people at risk for disease.
VI. Research Priorities in the Behavioral and Social Sciences
Dr. Raynard Kington, Director, NIH Office of
Behavioral and Social Sciences Research (OBSSR), provided an overview of a
National Research Council (NRC) report, New Horizons in Health: An Integrative
Approach. The report, prepared by the NRC Committee on Future Directions for
Behavioral and Social Sciences Research at the NIH at the OBSSR's request,
calls for expanded activities at NIH in the following areas of research in the
behavioral and social sciences: predisease pathways (identify precursors of
disease at earlier points); environmentally induced gene expression (identify
the complex dynamic interactions of genetic and environmental causal factors
including behavioral and social factors); personal ties (identify the
relationship of personal relationships and gene expression, brain structure,
neuroimmunological activity, and ultimately physical health outcomes); healthy
communities (characteristics of communities versus that of individuals in
affecting health outcomes); population health (trends in population health and
health care over time); positive health (the presence of wellness versus the
absence of disease); inequalities (how the position of an individual within a
hierarchy influences morbidity and mortality); interventions, methodology and
training (new measurement techniques, study designs, and statistical
techniques); research infrastructure.
Dr. Peter Kaufmann, Division of Epidemiology and
Clinical Applications, briefly described some of the many activities the NHLBI
has undertaken in these areas. For predisease pathways these include the
Bogalusa Heart Study, the CARDIA study, MESA, the Kuopio and Whitehall studies,
the San Antonio Family Heart Study, and the NHLBI Family Heart Study. For
personal ties these include the Cardiac Arrythmia Suppression Trial, the Duke
Coronary Artery Disease Study, and ENRICHED. For inequalities there are the
Strong Heart Study and the Jackson Heart Study. For interventions there
are PATHWAYS and TAAG studies. With respect to infrastructure the
longitudinal studies generate large databases which are available to the
outside community.
During the discussion, NHLBAC members emphasized that
the above priorities are interconnected and can be addressed through
interdisciplinary research.
VII. Revised MERIT
Award Program Guidelines
Dr. Jim Kiley, Director, NHLBI Division of Lung
Diseases, described a revision to the NHLBI policy on MERIT (Method to Extend
Research in Time) awards such that amended applications are no longer eligible
for consideration. The revised guidelines will be posted on the NHLBI
website.
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.
VIII.
REVIEW OF APPLICATIONS
The Council considered 414 applications requesting
$596,364,204 in the total direct costs. The Council recommended 254
applications with total direct costs of $428,144,946. A summary of
applications by activity code may be found in Attachment B.
ADJOURNMENT
The meeting was adjourned at 5:30 p.m. on September 6,
2001.
CERTIFICATION
I hereby certify that the foregoing minutes are
accurate and complete.
Claude Lenfant, M.D.
Chariperson
National Heart, Lung, and Blood Advisory
Council
on 01/10/02
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