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Summary of the Sixth Annual Public Interest Organization Meeting

February 8-9, 2005 - Bethesda, Maryland


Summary Report

The National Heart, Lung, and Blood Institute (NHLBI) convened its sixth annual public interest organization (PIO) meeting to encourage and promote public input and involvement in Institute activities. Approximately 120 individuals participated in the meeting. They included members of more than 60 public interest organizations, as well as representatives from professional societies, voluntary health agencies and foundations, the NHLBI, and the National Heart, Lung, and Blood Advisory Council (NHLBAC). The participants met from 4:00 p.m. to 6:00 p.m. on February 8 and from 7:30 a.m. to 4:30 p.m. on February 9. The agenda and format for the meeting were designed to foster interaction among all the individuals and organizations attending. The five previous PIO meetings were held:

Themes that arose during the sixth annual meeting included the excitement and promise of newly emerging fields of science, the need for priorities in a time of limited resources, the importance of clinical and translational research, and the need for patients and PIOs to participate in this research. The agenda included:

This report summarizes the presentations and discussions at the meeting.

Welcome and Discussion of Future Directions

Dr. Elizabeth G. Nabel, Director, NHLBI, welcomed everyone to the meeting. She noted that the annual PIO meetings, which were initiated by Dr. Claude Lenfant, former Director, NHLBI, are wonderful opportunities for networking among the PIOs and with the NHLBI. As the new Director of the NHLBI, effective February 1, she welcomed the opportunity to learn more about the PIOs and the lives of the patients they represent. She noted that the needs of patients are motivations to help and she looked forward to partnerships and dialogue with all the PIOs.

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NHLBI Mission and Themes

Dr. Nabel described the NHLBI mission and four broad “messages,” or themes, guiding the Institute’s future directions. The NHLBI “plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects…related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, and sleep disorders.” The four broad messages are to:

All NHLBI activities are based on several fundamental values: excellence, integrity, innovation, respect, and compassion. Embracing these values, the NHLBI moves forward in collaboration, partnership, and synergy with others to set priorities for investing research dollars.

Stimulate Basic Discoveries

Stimulation of basic discoveries is the cornerstone of the NHLBI portfolio of activities. Dr. Nabel noted that, because most discoveries are serendipitous and are made by one investigator in a single research laboratory, the NHLBI emphasizes support of investigator-initiated research. To foster new discoveries, the NHLBI will:

Speed Translation to Clinical Applications

Clinical research has been a vital component of NHLBI activities for many years, and it is essential for development of new diagnostic and treatment strategies to help patients. Translational research to speed basic research findings into clinical practice also is of paramount importance. Dr. Nabel noted that, because most basic research discoveries derive from observations in patients, the NHLBI will continue to support translational research—from bedside to bench, and bench to bedside. To foster this research, the NHLBI will continue to:

Facilitate Scientist-Physician Communication

The NHLBI values collaborative basic and clinical research conducted by multiple, interdisciplinary teams of researchers. Multi-team research is imperative as science becomes more complex. To foster communication between research scientists and physicians, the NHLBI is:

Communicate Effectively to the Public

The Office of Prevention, Education, and Control (OPEC) is the Institute’s vehicle for prevention and public health programs. The NHLBI:

People • Science • Health

The NHLBI fosters innovation and creativity, “win–win” situations, synergism, and effective use of limited resources. Dr. Nabel noted that the continuous connections among people, science, and health surround the NHLBI and its activities. The PIOs can have an important role in helping the NHLBI build and diversify its strategies and programs. Most important, PIOs can:

Dr. Nabel emphasized that the NHLBI promotes the health of patients and the public. She noted that, as Director, she will ensure that the NHLBI continues to serve the public with the highest integrity and to preserve and protect the public’s trust.


The PIO representatives congratulated Dr. Nabel on her appointment as Director, NHLBI. They asked about NHLBI activities and commitment in the following areas: new imaging techniques for diagnosis and treatment, training of physician scientists, access to supplemental oxygen for patients in need, allocation of funds between heart and lung diseases and between prevention and treatment, prevention and cessation of tobacco use, trans-NIH committees, public awareness and early detection of chronic obstructive pulmonary disease (COPD), and transition from pediatric to chronic, adult disease. Dr. Nabel and NHLBI staff responded as follows.

Imaging. The NHLBI has a mature, sophisticated imaging program that has focused on magnetic resonance and computerized tomography and is expanding to include new initiatives in molecular imaging. Imaging is an innovative area of research, and the NHLBI will dedicate considerable resources to it in the future—to develop new techniques and to incorporate them into clinical trials. The NHLBI is collaborating in this area with other NIH components such as the National Institute of Biomedical Imaging and Biotechnology.

Training of Physician Scientists. The NHLBI’s primary mission is research and, in that context, it supports the training of physician scientists. The NHLBI would be supportive of efforts by PIOs and physician groups to increase the number and training of physicians in critical health areas.

Supplemental Oxygen. The NHLBI has partnered with other Federal agencies to give priority to the development of guidelines and reimbursement policies for use of supplemental oxygen. The Institute supports research on use of supplemental oxygen through the COPD Clinical Research Network and, in collaboration with the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, convened a working group of experts to identify issues related to long-term oxygen treatment in COPD.

Allocation of NHLBI Funds. Excellence in research drives the allocation of NHLBI funds. The Institute funds the most promising research ideas and strives to balance and diversify its research portfolio. The NHLBI engages in far more prevention activities than do other NIH components, and it partners creatively with other organizations to enhance the impact of its budget for these activities.

Tobacco Use. The NHLBI continues to be committed to the prevention and cessation of tobacco use. Staff continue to meet with groups advocating against smoking.

Trans-NIH Committees. The NHLBI participates in the trans-NIH Sarcoidosis Working Group established at the request of the NIH Director, Dr. Elias Zerhouni. The NHLBI also participates in the Trans-NIH Sleep Research Coordinating Committee, the Trans-NIH Coordinating Committee on the Lymphatic System, and the NIH Obesity Research Task Force. The NHLBI pursues collaborations with other NIH components to leverage its funds for greater impact.

COPD. The NHLBI is planning a number of programs to promote public awareness and early detection of COPD. Based on the recommendations from an NHLBI-sponsored Education Strategy and Development Workshop on COPD in September 2004, the Institute is forging a plan of action and identifying potential partners for these efforts.

Chronic Diseases. Major diseases, such as congenital heart disease, and rare diseases that begin in childhood often become chronic disorders in adulthood. The transition from pediatric to adult disease presents many complications. The NHLBI has established Specialized Centers of Clinically Oriented Research in Pediatric Heart Disease and its OPEC will be developing specific programs in pediatric diseases that will address the transition to adulthood.

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Program Activities of the Office of Rare Diseases

Dr. Stephen Groft, Director, Office of Rare Diseases (ORD), NIH, described the activities of ORD and opportunities for PIOs to collaborate with the NIH. Established in 1993, the ORD received its legislative mandate in 2002. In Public Law 107-280 (November 6, 2002), Congress recommended that the ORD undertake both a public education and a research agenda at NIH. The Congress specifically called on the ORD to:

With an annual budget of approximately $16 million, the ORD addresses more than 6,000 rare diseases. The office supports intramural and extramural research, information development and dissemination, the Trans-NIH Working Group on Rare Diseases Research, and a LISTSERV for patient advocacy groups. All activities are cosponsored with other NIH components. Major activities are described below.

Intramural Research Program

With the National Human Genome Research Institute and other NIH components, the ORD cosponsors the following efforts at the NIH Clinical Center in Bethesda, Maryland:

In 2004, the bench-to-beside awards supported research on the following diseases: sickle cell disease, 22q11.2-hemideletion syndrome, mantle cell lymphoma, chronic granulomatous disease, primary pulmonary hypertension, myelodysplastic syndrome, Smith-Magenis syndrome, intraocular lymphoma, and plexiform neurofibroma in childhood cancer.

Extramural Research Program

The ORD also participates in supporting the following extramural activities with one or more NIH components:

Scientific Conferences

Dr. Groft noted that the ORD has begun a series of meetings with patient advocacy groups and NIH components to follow up on scientific conferences and to address obstacles to research progress. The agendas, participant lists, and summaries of all scientific conferences are available on the ORD Web site Rare Diseases Dr. Groft encouraged the PIO representatives to view these materials and to discuss with ORD the possibilities for convening a conference on their disease topic. The NIH uses the R13 and U13 mechanisms to support scientific conferences, and these awards are competitive. Dr. Groft strongly encouraged the PIOs to contact ORD and NIH program staff for assistance before applying for a conference award.

Rare Diseases Clinical Research Network (RDCRN)

This new clinical research network encompasses 10 research consortia in 2005. The consortia are addressing 10 areas of research on rare diseases: Prader-Willi syndromes, bone marrow failure, genetic diseases of mucociliary clearance, genetic steroid disorders, nervous system channelopathies, rare liver disorders, rare lung diseases, rare thrombotic disorders, urea cycle disorders, and vasculitis clinical research. The emphasis is on clinical research involving pilot studies and phase I and phase II trials.

Overall goals are to:

Each consortium includes investigators, institutions, and organizations, and each partners with patient advocacy groups and, potentially, industry. The consortia collaborate among themselves and with a centralized Data and Technology Coordinating Center serving the entire network.

The RDCRN includes a coalition of patient advocacy groups, and a representative of the coalition is a voting member on the network’s steering committee. The coalition’s main emphasis is recruitment of patients. It also advances implementation of the network, identifies best practices, develops guidelines for treatment and access to care, and contributes to continuing education programs at conferences.

Dr. Groft encouraged the PIOs to participate in the network’s research and activities. Information about the network is available at Rare Diseases Network. The network is currently activating research protocols and recruiting patients for a Web-based registry. Because of the limited funds available for research on rare diseases, Dr. Groft encouraged the PIOs to partner in accessing these funds.


This database is available online at CHID Dr. Groft encouraged the PIOs to notify the ORD of diseases that should be added to the site.

Trans-NIH Working Group on Rare Diseases Research

The aim of this trans-NIH working group is to coordinate NIH research and public education, identify research opportunities and advances, develop collaborative RFAs and Requests for Proposals (RFPs), and promote collaborative intramural and extramural research programs on rare diseases. The working group has met twice and considers the NHLBI outreach to PIOs as a model for other NIH components.

The working group is currently focusing on two research issues in rare diseases:

Other research issues that the working group will address are:

Opportunities for Collaboration

Dr. Groft encouraged the PIOs to “get to know” the program staff at ORD and other NIH components. The NIH values the role and participation of patient advocacy groups as collaborators in NIH activities, and NIH staff are always ready to answer questions and share information.

Many opportunities for collaboration are available. For example, PIO representatives may:

To collaborate effectively with the NIH, the PIO leaders will want to learn about and understand the:

Dr. Groft encouraged the PIOs to interact with each other to obtain emotional support, share anxieties and fears, and “help yourselves a little bit.” He particularly urged the PIOs to attend meetings of the:

Contact Information

The ORD Web site Rare Diseases contains information on rare diseases, research and clinical trials, research resources, genetics, patient support groups, patient travel and lodging, and scientific conferences and reports. Staff may be reached by telephone at 301-402-4336, by fax at 301-480-9655, and by e-mail at ORD@nih.gov. Information about ongoing clinical research is available at Clinical Trials.

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Meet NHLBI Program Staff

The participants met with NHLBI program staff in six informal discussion groups, which were held simultaneously. Staff described research activities and addressed questions raised in discussion. The six discussion groups were:

  • Heart development and diseases
  • Vascular diseases
  • Lung diseases
  • Airway diseases
  • Blood diseases and resources
  • Sleep and sleep disorders.
  • The participants highlighted informative resources and Web sites and suggested activities that the PIOs and the NHLBI could undertake collaboratively to foster research. NHLBI staff encouraged the PIOs to:

    Two overall messages were:

  • From the PIOs to the NHLBI—“Keep up the good work.”
  • From the NHLBI to the PIOs—“We need your help.”
  • Scientific Sessions

    Six research technologies that are advancing science and understanding of human health and disease in the 21st century are:

    The participants at the meeting had an opportunity to learn about advances already made and the promise of these technologies for the near future. Each session included a question-and-answer period.

    Nanotechnology in Heart, Lung, Blood, and Sleep Research

    Dr. Denis Buxton, Assistant Director, Heart Research Program, DHVD, described nanotechnology and NHLBI research initiatives in the field. NHLBI efforts to take advantage of nanotechnology began in January 2003 when the Institute issued a Request for Information from the scientific community on the role of the NHLBI in developing nanotechnology. In February 2003, the NHLBI convened a Working Group on Nanotechnology in Heart, Lung, Blood, and Sleep Medicine. The group, which consisted of engineers, chemists, biologists, and physicians, reviewed the challenges and opportunities offered by nanotechnology and identified four areas for NHLBI efforts:

    Dr. Buxton described each area. He noted that nanotechnology has enormous potential for diagnosing and treating heart, lung, blood, and sleep diseases and disorders. It could be used in diagnostics to measure simultaneously the amounts of different proteins in blood (e.g., those that signal a heart attack) and to identify an infectious virus or detect DNA mutations that cause disease. It also could be used to make better artificial veins and arteries and heart valves, to grow patches of heart tissue for repairing damage from heart attacks, and to grow artificial lung tissue.

    One difficulty is that materials at the nanoscale gain new properties, which differ from their properties at the macroscale and make it hard to predict how they will perform. Researchers are working to make nanomaterials stable and safe so that nanoparticles eventually can be used as medicines. The biosafety of nanoparticles and nanodevices will be evaluated carefully before they are approved for use in humans.

    The NHLBI and the NIH support research on nanotechnology and its applications. Specific initiatives include the following:

    The participants asked about the timeframe for development and application of nanotechnologies. Dr. Buxton noted that, for any new technology, predicting the progress of research and development is difficult. Clinical testing of nanoparticles and nanodevices in humans is not likely to begin for 5-10 years, and another 5 years are probably needed before the materials are used in clinical practice. Applications of nanotechnology that are less invasive (e.g., diagnostic blood tests) could probably be available much sooner. Getting nanotechnology into the clinic will depend on collaborations among biologists and physicians, material scientists, physicists, and engineers.

    Cell-based Therapies: Progress and Challenges

    Dr. Liana Harvath, Deputy Director, DBDR, defined key terms and described NHLBI programs and challenges in cell-based therapies. Researchers are exploring the use of autologous cells, which are obtained from, and returned to, the patient, and allogeneic cells, which are obtained from a donor, who may be related or unrelated, and given to the patient. The Food and Drug Administration (FDA) regulates the processing of cells-collection, testing, and storage-and cell products used in clinical trials.

    Through the Production Assistance for Cellular Therapies (PACT) program, the NHLBI supports development and manufacturing of cell products for research and application. Initiated in 2003, the program currently involves three university sites that are focusing on six cell products. As of 2004, the NHLBI also supports the Center for Human Cell Therapy at Harvard Medical School, which is conducting translational research, as well as research training, to move products into clinical trials. In 2005, the NHLBI will fund three Specialized Centers for Cell-Based Therapy to develop collaborative and multidisciplinary clinical research that will improve the function and outcome of patients with heart, lung, blood, and immune system disorders.

    One example of success in developing cell-based therapies is the banking and transplantation of placental cord blood. Worldwide interest in cord blood collection began in 1988 with the first successful transplant of cord blood between siblings to treat the inherited disorder of Fanconi anemia. Dr. Harvath noted that the recipient is still living and is free of the disease. Now, years later, some 20 for-profit U.S. companies solicit families to store children's cord blood, and the NHLBI supports research on the collection, banking, and transplantation of cord blood.

    Three major NHLBI efforts have been:

  • A demonstration grant awarded to the New York Blood Center in 1992. The center, now independent, is the world's largest cord blood bank.
  • The Cord Blood Banking and Transplantation (COBLT) study, initiated in 1996. Under contract, two blood banks collected blood units from ethnically diverse donors, and 27 U.S. transplant centers performed more than 350 transplants to unrelated patients using this blood. The results of the study, which are being published, show that outcomes are similar for cord blood or bone marrow transplantation and that cord blood transplantation is a viable option for treatment.
  • The Children's Hospital Oakland Research Institute (CHORI) Sibling Cord Blood Program, initiated in 1999. This program supports cord blood banking and transplantation for sibling donors in families that have a child with a hematologic malignancy, sickle cell disease, or thalassemia. The transplant protocol was developed in 2001 to evaluate the safety and efficacy of the transplants in children with sickle cell disease or thalassemia
  • Dr. Harvath noted that the NHLBI could foster collaboration between PIOs and the CHORI investigators. She also noted that the Health Resources and Services Administration is expected to fund a contract for a national cord blood bank program in 2005 and that FDA licensure of cord blood products is likely to occur in the near future.

    The remaining challenges include the need to:

  • Convey a balanced message to consumers about the benefits and limitations of cord blood
  • Improve the outcomes of cord blood transplants in adult recipients
  • Improve the availability of cord blood units appropriately matched to patients
  • Maintain a high-quality inventory of banked cord blood units for transplantation.
  • Genetics, Genomics, and Proteomics at the NHLBI

    Dr.Susan Old, Associate Director, Clinical and Molecular Medicine Program, DHVD, discussed three topics in the context of systems biology:

  • Gene discovery
  • Gene-environment interactions
  • Applications and resources.
  • For each, she addressed researchers' ability to examine all elements in a biological system, measure their relationships to one another, and predict their actions as the system functions in response to biological or environmental perturbations.

    Gene discovery involves research onthe expression of genes and proteins and variations in DNA. It includes targeted and genomic approaches and comparative genomic studies. The development and use of animal models (e.g., gene "knockout" mice) are critical for locating genes and identifying their function.

    In studies of the link between genes and the environment, researchers are describing mechanisms of interaction between genes and environment in the body. Importantly, they are elucidating the relationship between genes and individual variations in response to treatment.

    Post-translational modification of proteins is another growing area of research. Pursuing this concept, researchers are emphasizing detection of proteins as cells progress from health to disease. Efforts are underway to develop "biosignatures" that can be used to associate a cell's protein content with specific disease conditions.

    The NHLBI is providing essential resources for these studies through its:

  • 11 Programs for Genomics Applications
  • National Heart, Lung, and Blood Proteomics Initiative
  • Laboratory Centers for NHLBI DNA Re-sequencing and Genotyping Program
  • Shared Microarray Facilities.
  • Advances in Imaging

    Dr. Elliot McVeigh, Principal Investigator, Laboratory of Cardiac Energetics, Division of Intramural Research, discussed recent advances in magnetic resonance imaging (MRI), a technique that has become state-of-the-art in imaging the cardiovascular system. MRI is used to diagnose abnormalities and disease and could be used potentially to enhance therapy.

    In a clinical trial of patients with acute chest pain, doctors at Suburban Hospital in Bethesda, Maryland, are using MRI to rapidly diagnose heart problems. As a diagnostic tool, MRI can be used to:

  • Locate areas of the heart that are deprived of blood
  • Identify abnormalities in the structure of the heart or in blood flow
  • Assess other measures of injury to the heart.
  • MRI also can be used with contrast agents to help guide the management of patients who suffer a heart attack. Within the NHLBI intramural program, researchers are exploring magnetic resonance as a real-time imaging technique. Real-time MRI could enhance therapeutic procedures by guiding doctors as they perform heart surgery or as they deliver therapeutic agents to a particular part of the heart.

    Tissue Engineering

    Dr. Martha Lundberg, Health Scientist Administrator, Clinical and Molecular Medicine Program, DHVD, described the process of tissue engineering and presented examples of NHLBI research. Tissue engineering is a multidisciplinary field. The necessary components are animal models (e.g., rats); cells (e.g., skeletal myoblasts); tissue constructs (artificial scaffolds), which are implanted first in animals and then in humans; functional and cellular analyses of the test implants; and implant surgery.

    Tissue engineering builds on advances in research on medical devices to offer alternative treatments for individuals who have few or no other options. Tissue engineering addresses the difficulties experienced with medical devices (e.g., biocompatibility, durability) by applying biology-based concepts essential for realistic applications.

    The NHLBI supports tissue engineering to improve treatment of heart, lung, and blood vessel diseases. This research has great potential for improving function and host response in humans with these diseases. Most of the research is being conducted in laboratories and animal models. A few tissue-engineered products are being tested initially in humans. The overall goal is to create biologically based implants that will last for 20–30 years or more.

    Some important efforts supported by the NHLBI are:

    Tissue engineering is an important component of the NIH Roadmap. In addition, the NIH participates in several Federal collaborations focused on tissue engineering to improve human health. These include the:

    Patching Your Genes: Converting Gene Therapy's Promise to Practice

    Dr. Sonia Skarlatos, Deputy Director, DHVD, and Gene Therapy Coordinator, NHLBI, addressed the following topics:

    Dr. Skarlatos explained the underlying principles of gene therapy, the concepts of ex vivo and in vivo gene therapy, and the use of viral and nonviral vectors to deliver genes.

    The challenges and safety of gene therapy relate to finding the ideal vector, producing large quantities of the vector, targeting the appropriate organ, regulating gene expression, eliminating toxicity, and controlling the patient’s immune response to the vector.

    The regulatory process for NHLBI studies of gene therapy involves the FDA, the NIH Recombinant DNA Advisory Committee, the NHLBI Data and Safety Monitoring Board, and institutional review boards. Regulations are in place for expedited safety reports and long-term follow-up.

    The transition of research from bench to bedside begins with basic genomic and cellular research that proceeds to the use of animal models for testing and, ultimately, phase I, phase II, and phase III clinical trials in patients. Progression through the series of trials depends on success at each phase, and if any phase fails to meet its objective, the research returns to basic genomic and cellular studies. The FDA does not grant approval for general clinical use of any gene therapy until a phase III trial has been completed successfully.

    Potentially, gene therapy offers effective treatment for patients with heart, lung, and blood diseases. Individuals with heart failure, alpha-1 antitrypsin deficiency, or hemophilia are some of those who may benefit eventually.

    The NHLBI supports a variety of resources for research in gene therapy. Through these activities and other mechanisms, the NHLBI supports research training in gene therapy. NHLBI resources include:


    In two separate sessions, the participants joined in one or more roundtables to share information and experiences in seven areas of PIO activity:

    Two or three PIO representatives chaired each of the seven roundtables. The cochairs provided information, initiated and led the discussions, and answered questions. The discussions were free-flowing and vigorous. They generated many new ideas and helpful hints for PIOs at different stages of organization and development.

    Clinical Trials and Tribulations

    Dr. Sally Shumaker, Principal Investigator, NIH Women's Health Initiative Clinical Coordinating Center, Wake Forest University, Winston-Salem, North Carolina, presented an overview of the history, science, and promise and challenges of the Women's Health Initiative (WHI). In 1991, the NIH Director, Dr. Bernadine Healy, proposed the WHI to improve understanding of the major causes of morbidity and mortality in women. The initiative was a response to the paucity of women's health research and data, as noted by women's grass-roots organizations, researchers, and Congress during the 1980s. Also during the early 1990s, the NIH established the Office of Research on Women's Health and policies governing the inclusion of women and children in federally funded research.

    The WHI is a large, complex set of studies focused on the key health concerns for women (heart disease, breast cancer, colorectal cancer, osteoporosis) for which promising treatments were emerging. The WHI involves 40 clinical centers throughout the United States and a coordinating center in Seattle, Washington. Researchers are following more than 100,000 women, who were 50-79 years of age at baseline, for an average of 8.5 years. The design includes an observational study and clinical trials to assess primary and secondary outcomes of hormone therapy, diet modification, and calcium and vitamin D supplementation, respectively.

    Dr. Shumaker elaborated on the promise, risk, design, challenges, and unexpected outcomes of the hormone trials (one of estrogen-plus-progestin, for women with a uterus, and one of estrogen alone, for women who had had a hysterectomy). In July 2002, the NIH stopped the estrogen-plus-progestin trial because the evidence showed that the risks of hormone therapy exceed the benefits. The WHI is a prevention trial, and interventions cease when no potential benefits are shown. The stopping of this large trial and the subsequent halting of the estrogen-alone trial as well, had a dramatic and sudden effect on health care, reversing the trend to prescribe hormone therapy for asymptomatic and older women and leading the FDA to change its labeling on hormone treatments. Because of the unexpected results, researchers are critically examining the assumptions and questions addressed in the trial, analyzing existing data further, determining new directions for research, and continuing to follow the participants to identify any effects of ceasing therapy.

    Dr. Shumaker suggested that the WHI has demonstrated that:

    The WHI continues, and the results of the diet modification and calcium/vitamin D trials will be published in late 2005. The observational study continues to produce information on possible health risks for women, which could be explored in new randomized studies. As the WHI continues to follow participants, it will provide critical information on women's health for decades to come.

    The NHLBI coordinates the WHI. For more information, see WHI.

    Perspective of a Clinical Trial Participant

    Dr. Gene Gary-Williams, Volunteer Participant, WHI, described her participation in the Estrogen-Plus-Progestin (E+P) Study of the WHI Postmenopausal Hormone Trials during 1997-2004 at MedStar Clinical Research Center, Washington, D.C. She noted that she chose to participate because of the:

    Dr. Gary-Williams said that the experience of participating in the trial was wonderful and that she would do it again “in a heartbeat.” She highlighted the positive aspects of participating in the trial, noting, in particular, that she:

    Dr. Gary-Williams emphasized the importance of persons of color participating in clinical trials—to obtain needed data—and she strongly encouraged others to volunteer and participate in clinical trials and research.

    Demonstration of NIH Resources

    During the meeting, NHLBI staff demonstrated (using a computer) NIH resources available on the Internet. Some key Web sites are:

    For Research Information

    PubMed (research articles) Query
    MedlinePlus (research articles) Medline
    CRISP (NIH supported research and researchers) CRISP
    Clinical Trials (list of trials) at Clinical Trials
    NIH Guide for Grants and Contracts (policy guidance and initiatives) at NIH Guide

    For Health Information

    NHLBI Health Information Network HIN
    NIH news and information NIH News
    Articles available for publication Word on Health recently updated to News In Health
    Website of the U.S. Department of Health and Human HHS

    For NIH Information and Access

    NIH Roadmap Roadmap
    NIH public access site Public Access
    NIH Director's information site NIH Director
    NIH public bulletin Bulletin

    NIH Director's Council of Public Representatives

    Ms. Wendy Chaite, Founder and President, Lymphatic Research Foundation, presented an overview of the functions and recent activities of the NIH Director's Council of Public Representatives (COPR), of which she is a member. She also highlighted the important role of NIH Public Liaison Officers.

    In her remarks, Ms. Chaite encouraged the PIOs to access NIH resources for the public. She urged PIOs to apply to receive the NIH public bulletin, at Public Bulletin, and to be on the LISTSERV of COPR.


    The NIH Director established the COPR in 1998 as a Federal advisory committee. Composed of 21 members of the public who serve terms of up to 3 years, the COPR is chaired by the NIH Director. Through meetings, working groups, and teleconferences, the COPR fulfills several key functions. It:

    On October 26-27, 2004, the COPR held a major workshop to advise the NIH Director. Entitled “Inviting Public Participation in Clinical Research: Building Trust through Partnership,” the workshop had three purposes: to assess the current status of public participation and trust in medical research, to suggest interrelationships and strategies to build partnerships nd engender trust, and to identify barriers and opportunities for building public participation and trust. A workshop summary, Report and Recommendations on Public Trust in Clinical Research, is available at COPR Reports.

    NIH Public Liaison Officers

    Each NIH component and the Office of the Director, NIH, has a Public Liaison Officer. Their goals are to:

    Ms. Chaite encouraged PIOs to communicate with these individuals. The NHLBI Public Liaison Officer is Ms. Cindy Palace (301-496-9899).

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    Closing Remarks

    Dr. Nabel thanked the PIO representatives and the NHLBI staff for their contributions and participation.

    The meeting was adjourned at 4:25 p.m.

    Modified 6/28/05
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