Director's Council of Public Representatives

Fall 1999 Meeting Minutes

Department of Health and Human Services
Public Health Service
National Institutes of Health
Council of Public Representatives
Summary Minutes

October 21, 1999

The Council of Public Representatives (COPR) convened its second meeting at 8:30 a.m., Thursday, October 21, Building 31C, Conference Room 10, National Institutes of Health, Bethesda, Maryland. The meeting was open to the public.

Dr. Harold Varmus, Chairman, COPR, and Director, National Institutes of Health (NIH), presided.

Council Members Present:

• Michael D. Anderson
• Theodore Castele
• Robin Chin
• Mary desVignes-Kendrick
• Melanie C. Dreher
• Pam Fernandes
• David Frohnmayer
• Vicki Kalabokes
• Barbara Lackritz
• Joan Lancaster
• Debra R. Lappin
• Isaac Montoya
• Rosemary Quigley
• Maurice F. Rabb
• Bob Roehr
• Thomas Vaalburg
• Douglas Yee

Council Members Absent:

• Luz Claudio
• Lydia Lewis
• Roland McFarland

Others Present:

• Public Observers
• Members of Staff, NIH

Invited Speakers:

• Dr. Enoch Gordis, Director, National Institute on Alcohol Abuse and Alcoholism
• Dr. Marvin Cassman, Director, National Institute of General Medical Sciences
• Dr. Duane F. Alexander, Director, National Institute of Child Health and Human Development
• Dr. Carl Kupfer, Director, National Eye Institute
• Dr. David Lipman, Director, National Center for Biotechnology Information, National Library of Medicine
• Dr. Gerald T. Keusch, Director, Fogarty International Center
• Dr. Lana Skirboll, Associate Director for Science Policy, NIH

I. Welcome and Opening Remarks

Dr. Varmus welcomed COPR members, guests, and staff and announced that the Council meeting would be open to the public. The next meeting of COPR will be on April 6 and 7, 2000.

Dr. Varmus announced that this would be his last meeting with the Council. He is leaving NIH at the end of the year to become president of the Memorial Sloan-Kettering Cancer Center. During the transition, Deputy Director Dr. Ruth Kirschstein will serve as Acting Director. Dr. Varmus has urged Secretary Shalala and the White House to make a prompt and nonpartisan nomination for his successor, in hopes of decoupling this position from the political cycle. One member suggested that COPR should have an input in this process, and Dr. Varmus said that COPR members could bring this suggestion to the Secretary's attention.

Dr. Varmus introduced several new staff members, including Marc Smolonsky, the head of the Office of Legislative Policy and Analysis; Susan Quantius, the head of the Office of Financial Management; and Dr. Stephen Straus, head of the National Center for Complementary and Alternative Medicine. He also introduced Jennifer Gorman, who will serve as the Public Liaison Coordinator in the Office of Communications and Public Liaison, with direct responsibility for the COPR. He then covered several topics in response to prior inquiries from COPR members.

Dr. Varmus announced that the NIH budget will increase significantly in the next fiscal year. The President's budget had asked for an increase of 2.1 percent for the FY2000 over the 1999 increase; the House markup was an increase of about 9 percent, while the Senate version called for an increase of about 13 percent; and the final conference bill looks like an increase of 15 percent. In response to questions from the Council, he added that NIH would spend these unexpected increases according to priorities included in their long-range planning. The June 1999 budget retreat, which some COPR members attended, was to plan for the FY2001 budget, which won't start until October 2000. Extramural spending would probably increase more than intramural, as it has for the past few years.

Dr. Varmus described the decision to move the Office for Protection from Research Risks (OPRR) from NIH to the Office of the Secretary, Health and Human Services (HHS). This removes the appearance of a conflict of interest, since research by NIH scientists and grantees is also subject to OPRR oversight. The new office will have an advisory panel and a Director at the Senior Executive Service level, higher than the rank of the present position; it will also have increased resources to deal with the workload arising from the growth of clinical research. On a related topic, he announced that the White House Office of Science and Technology Policy has released a report that clarifies the definition of scientific misconduct and sets out principles for investigating alleged misconduct.

On the subject of embryonic stem cells, Dr. Varmus said that, in the view of the DHHS General Counsel, it would be appropriate under current law for NIH to provide funds for research that uses such cells but not to expend funds for the derivation of such cells. The September report of the National Bioethics Advisory Commission supported the use of federal funds for both the use and the derivation of stem cells, although the latter is not allowed under current law. There may be a congressional debate on embryo research early next year, but in the meantime NIH has moved forward with planning and draft guidelines that would govern the way in which NIH supports research on embryonic stem cells; the guidelines will soon appear in the Federal Register for public comment.

Dr. Varmus announced that COPR members were already participating in a number of NIH committees and activities, including the GPRA (Government Performance and Results Act) committee, the June budget retreat, and the committees that review the performance of institute directors. In addition, 220 of the COPR applicants have agreed to serve as COPR Associates and are already receiving a newsletter from the Office of Communications and Public Liaison. He asked that COPR members who are interested in working with this group contact Anne Thomas. He also asked that COPR consider ways of encouraging advocacy groups to create small prizes or incentive awards for individuals or organizations that achieve specific scientific or medical goals.

On other matters, Dr. Varmus announced that the Clinical Trials Database, which was described at the last COPR meeting, now contains about 4,000 trials in a prototype version and is due for formal launch in January 2000; members should ask Anne Thomas for details. Biomarkers, which may improve the speed, efficiency, and costs of clinical trials, have been the subject of a policy workshop; members should contact Dr. Lana Skirboll for details. NIH has also issued proposed guidelines to promote access to and sharing of research resources; details are available on the NIH Website. Finally, a few months ago, President Clinton attended the groundbreaking ceremony for the Dale and Betty Bumpers Vaccine Research Center on the NIH campus, and Mrs. Clinton recently held the 8tthMillennium Evening at the White House lecture entitled "Informatics Meets Genomics". The genomics portion of the lecture was given by Dr. Eric Lander, a member of the Advisory Committee to the Director, NIH. Dr. Eric Lander currently serves as the Director of the Whitehead Institute/MIT Center for Genome Research. He and his research group have developed many of the tools of modern genome research. The informatics lecture was given by Dr. Vinton Cerf, known as a "Father of the Internet" for his work with the U.S. Department of Defense's Advanced Research Projects Agency (DARPA). He currently serves as senior vice president of Internet Architecture and Technology for MCI WorldCom. He served on the National Library of Medicine Board of Regents and in December 1997, he was awarded the U.S. Medal of Technology by President Clinton. Videotapes of these events are available from the NIH Office of Communications and Public Liaison (OCPL).

In response to questions from the Council, Dr. Varmus also described proposed changes in the structure and activities of the Center for Scientific Review (CSR), which is responsible for evaluating extramural grant proposals. At issue is whether the compositionBwith respect to topic-- of the study sections, which are now grouped within initial review groups, is consonant with the current state of science, and what effect changes might have on the funding process. The Panel on Scientific Boundaries for Review, chaired by Dr. Bruce Alberts, head of the National Academy of Sciences, has already recommended changes in the overall structure of these groups. Public comment on Phase 1 of this process ended on October 15, with many comments by scientific societies, and by the end of 1999 there will be a final draft of recommendations for the framework of how to begin to cluster the scientific topics. Phase 2 will carry out the actual populating of the clusters with individual study sections.

II. How the Public is Involved in NIH Activities

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), emphasized that alcohol abuse and alcoholism are both biological and behavioral disorders, the social costs of which have recently been estimated at $185 billion. About 10 percent of the adult population have characteristic features of alcoholism, or "alcohol dependence" in the current medical language. The consequences of alcohol problems fill 20 to 25 percent of adult hospital beds in this country. NIAAA's research mission includes a broad range of biological and behavioral topics. Notable recent advances have been made in neuroscience and the genetics of alcoholism, and NIAAA is using those advances to help focus on the prevention and treatment of the disorder.

To carry out its research mission, NIAAA solicits advice from a wide variety of organizations.

The Institute has ongoing liaison relationships with over 250 scientific, community, and patient advocacy groups, many of which regularly attend meetings of NIAAA's National Advisory Council. After the council meetings, Dr. Gordis sits down with the liaison groups represented at the meeting and discusses their concerns. These are "no agenda, all are welcome, any topic is fair game" meetings. Further, at the Council's recommendation, the Institute set up an outside committee of experts to review its extramural research portfolio. The Council has recommended, and NIAAA has heeded their recommendations, a greater emphasis on topics such as health services research and college drinking. The Institute of Medicine (IOM) has recommended that NIAAA pay increased attention to fetal alcohol syndrome and to the treatment for alcoholism. In addition, Congress has urged the Institute to focus on whether early onset drinking is related to the risk for developing alcoholism as an adult (it is).

NIAAA also supports a number of activities designed to share the results of this research with the public. These include the publication of quarterly journals (Alcohol Research and Health), research summaries (Alcohol Alert) as well as a Web site, and activities such as participation in the Kettering Foundation Issue Forums, support for the Governors' Spouses Initiative on Underage Drinking, and lead sponsorship of the annual National Alcohol Screening Day. In response to questions from COPR, Dr. Gordis explained that the screening initiative reached a total of 26,000 people at a variety of sites, with the option of a confidential interview and referral where indicated. COPR members suggested that referral should include information on insurance coverage for treatment; at the federal level, this is largely the responsibility of other agencies. In response to another question, Dr. Gordis stated that NIAAA has undertaken a major review of research on drinking on college campuses, which will lead to a national research research agenda, precisely because there is a general lack of research or evaluation of ways to approach this problem.

Dr. Marvin Cassman, Director of the National Institute of General Medical Sciences (NIGMS), explained that his institute focuses not on a single disease, organ, or population, but rather on basic biomedical research that provides the foundation for future advances in disease research. The Institute also administers a broad, multidisciplinary research training program, the biggest part of which supports predoctoral training. This includes almost one-half of all NIH predoctoral trainees and about one-third of all NIH-supported trainees. Another program is focused on increasing the number of underrepresented minorities in research. NIGMS also tries to educate the general public on the value of basic biomedical research. Several NIGMS science education publications are used by high schools and colleges.

NIGMS solicits advice and input on the direction of its research from the many publics that are affected by it. One important public is made up of scientific and professional societies. NIGMS is also working with an advisory group of public representatives from diverse populations to help address the issues that could arise from studies of how people's responses to medications differ based on their genetic inheritance. The Institute asked several COPR Associates for advice on establishing oversight groups for its human genetic cell repository to address the ethical, legal and social issues that could arise from the collection of cell samples from identified populations. NIGMS is also working with the Indian Health Service to bring more Native Americans into biomedical research. In response to requests from COPR, Dr. Cassman will send each member a copy of the NIGMS publication entitled "Why Do Basic Research?"

Dr. Duane Alexander, Director of the National Institute of Child Health and Human Development (NICHD), described their research and outreach programs. The Institute's research focuses not on an organ or a disease but rather on the whole spectrum of human development. As a result, they interact with a wide variety of professional societies and advocacy groups, whose input and assistance they seek in setting their research priorities. NICHD works with groups to share information through a unique coalition of more than 100 public organizations called the Friends of NICHD Coalition. One example of an extremely successful partnership is the "Back to Sleep" campaign, in which NICHD and the National Academy of Pediatrics created public-private partnerships in numerous communities to inform and educate parents on the benefits of putting infants to sleep on their back to reduce sudden infant death syndrome. The public information campaign, which included warnings on cereal boxes and even on disposable diapers, was successful precisely because it was tailored to the needs and languages of specific communities. Other examples include the "Milk Matters" campaign, which included the well-known milk moustache ads to promote calcium intake by children, and a partnership with the Modell Foundation to provide technical assistance in educating parents of children with primary immune deficiency.

NICHD has formed a new Office of Legislative and Public Liaison and intends to expand its educational efforts in the future. The Institute's strategic plan is posted on their Website for public comment, and they hope to identify additional public organizations with which to communicate and cooperate. In response to questions from COPR members, Dr. Alexander added that NICHD does research on improving and developing new and more effective contraceptives. It is also addressing school violence as part of a HHS-wide initiative that includes other NIH Institutes and the NIH Office of Behavioral and Social Sciences Research. "Milk Matters" materials have been translated into Spanish and French. NICHD welcomes suggestions from COPR.

Dr. Carl Kupfer, Director of the National Eye Institute (NEI), explained that public advocacy played a key role in getting Congress to establish the institute through a 1968 campaign by the Lions Club that generated 100,000 letters to Congress supporting the creation of NEI. Public liaison activities fall into three groups:

• Participation in oversight (NEI's National Advisory Council includes four public members);
  
• Participation in planning and setting of research priorities (the comments and input of professional, civic and advocacy groups were solicited in drafting the new NEI Strategic Plan); and
  
• Public information and outreach activities such as the National Eye Health Education Program (public service announcements, traveling exhibits, education programs, and school curriculum materials reach millions of Americans in cities across the country).

NEI has established two Public Affairs Networks—one for departments of ophthalmology at universities and medical centers, the other for schools and colleges of optometry—to help educate Americans about the benefits of public investments in vision research. NEI's Website includes a searchable database of clinical trials and information on how to refer or participate in clinical research. In response to questions from the group, Dr. Kupfer added that NEI's goal is first to prevent the loss of vision, and then to maximize residual vision. NEI materials are available in large type, and there is a text-only version of its Web site.

III. NCI Research Program Relating to Health Disparities

Dr. Richard Klausner, Director of the National Cancer Institute (NCI), reported on NCI's response to the IOM report on The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved. He pointed out disparities in the incidence, experience, and outcome of cancers among racial and ethnic minority groups. He framed his comments in terms of three overarching issues:

• The problems identified by the IOM report cannot be addressed in their entirety by NCI or NIH alone, because they are intricately interwoven with issues of poverty, culture, health insurance, and immigration. A much broader long-term response will be required.
  
• Race has no biological basis but is instead defined culturally, historically, politically, and socially. Nevertheless, the current categories (as defined by OMB Directive 15) will persist because they are required by law and because they provide a way to link cancer data with other data sets. NCI is working with other Institutes and agencies to develop a meaningful definition of "medically underserved."
  
• Issues of health disparities and unequal burdens should be integrated into all of NCI's research and outreach activities.

In response to the IOM finding that the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute does not adequately describe the burden of cancer for many U.S. ethnic, minority, and underserved populations, Dr. Klausner reported that NCI had already taken steps to improve the national surveillance system for cancer. SEER is a comprehensive database of information on cancer incidence and survival in the United States. SEER covers 14 percent of the U.S. population, but underserved populations of ethnic groups and minorities are heavily oversampled (40 percent of the sample). NCI makes the data and analytical programs available to any interested user and reports the conclusions on an annual basis.

In response to the IOM finding that NCI and NIH need to improve the accuracy of assessing how each is addressing the needs of ethnic, minority and medically underserved populations, Dr. Klausner suggested that any disparity in this area was an artifact of coding. An outside review agreed with NCI's accounting, but C more to the point C much of the new knowledge that addresses the needs of underserved populations comes from projects that were not initially 100 percent targeted to those groups.

The IOM report also concluded that NCI has no strategic plan, and inadequate funding, for its research on the unequal burden of cancer. Dr. Klausner agreed that funding was inadequate, as it is in most other areas. However, NCI has no strategic plan for this particular issue because it should be integrated into all of its activities, so that it may be addressed with the greatest relevance and expertise. He has created a standing Special Populations Working Group to the advisory committee of the Director, NCI, to link NCI efforts with the communities of interest. NCI will issue an annual report on its efforts to address this issue.

Finally, in response to the IOM's finding that the Office of Special Populations Research (OSPR) needs more resources and should coordinate grants and funding, Dr. Klausner suggested that it would be more effective for OSPR to monitor and report on all activities in this area across the Institute. NCI already has a formal working group to be part of OSPR, and the office does have funds and the capacity to create funding mechanisms if gaps, for example, are found. For example, last year, NCI proposed the creation of Special Populations Networks across the country to create coalitions and infrastructure within minority and underserved communities for cancer research, control, and communications activities. Already 52 applications have been received for this program.

In response to questions from the Council, Dr. Klausner said that genetics will eventually erase the concept of biological race, replacing it with the extended family history of groups, based perhaps on immunohistocompatibility or biomarkers rather than pigmentation or national origin. Dr. Varmus added that he has created an NIH-wide task force to develop definitions of what is meant by research in minority health and what is meant by research in health disparities, but that no further disease-specific reports are anticipated or needed.

IV. PubMed Central

Dr. David Lipman, Director of the National Center for Biotechnology Information, described the proposal to establish a central repository for the electronic distribution of primary biomedical research reports. The PubMed Central concept responds to the interest, not only from scientists, but also from the general public, and all information will be freely available to all users. The system will require the voluntary participation of scientific journals and societies, but several have already agreed to participate, including the American Society for Cell Biology, Canadian Medical Association, National Academy of Sciences, and Current Science Group. Discussions continue with other groups, and interest is growing. By January 2000 there should be sufficient content to launch the site.

In response to questions from the group, Dr. Lipman added that some of these groups already publish an online version of their journals, and others are eager to get out of the publishing business in order to reduce costs. At present PubMed carries only abstracts, but PubMed Central will carry full texts. In the long run there may be an international network of servers that share content and link users with global resources. As an indicator of public interest, up to one-third of the hits at the National Library of Medicine's MEDLINE database are from the public. Governance will include an advisory board of scientists, publishers, librarians, and public representatives.

V. NIH International Research Program

Dr. Gerald Keusch, Director of the Fogarty International Center (FIC), explained that NIH's international research program began as a "Marshall Plan for science, in Europe and subsequently in Japan, and today a major focus is on the "neglected 85 percent" of the world's population that live in developing countries. This emphasis is based in part on altruism and scientific curiosity, but also on enlightened self-interest: many of the disease threats to the United States are more revalent in these countries, presenting an opportunity for conducting research of benefit to both nations. Fogarty's mission is to mobilize scientific resources to reduce disparity in global health through research and training, to initiate and support research on international health issues, and to act as NIH's window on the world of global health.

One example of FIC outreach to domestic and international organizations is a new program in the ecology of emerging and reemerging infectious diseases so that we could predict and prevent them, rather than just respond to them. Another is the Ireland-Northern Ireland-NCI Cancer Consortium, which seeks to create infrastructure and enhance cooperation in cancer research on both sides of that border. FIC is working to establish a global research bioethics forum and is supporting the first meeting of that forum here at NIH next month. FIC is working with other Institutes and partners to support multinational initiatives in women's and children's health, tobacco-related disease, and malaria research. Dr. Keusch would like to report to COPR in the future on the results and impact of these initiatives.

COPR members pointed out the potential importance of FIC's international experience in developing methodologies for cross-cultural research at home. In addition, the speed of modern travel and communications mean that local public health officials need to have an international perspective. FIC collaborates with CDC on disease surveillance, but NIH is responsible for developing diagnostic tools. In addition, FIC supports not only vaccine development, but also vaccine deployment, wherever the disease exists.

VI. Privacy and Research Records

Dr. Lana Skirboll, NIH Associate Director for Science Policy, reported on the Department of Health and Human Services' (DHHS') efforts to establish a regulation that both protects the privacy of individually identifiable patient records, and ensures that research is not unduly impeded. Two forms of research are expected to be affected by the proposed rule: (1) research that uses individually identifiable health information, and (2) research that involves the delivery of health care. NIH-supported research that uses medical records must currently undergo local Institutional Review Board (IRB) review as required by the Common Rule (45 CFR 46, Subpart A). It is expected that the DHHS proposed privacy rule will extend the protection of IRB or IRB-like review to all research that uses individually identifiable health information, regardless of funding source. In addition, since researchers who deliver health care as part of a research study are expected to be covered entities under the proposed rule, complicated privacy issues will arise about how to appropriately protect the privacy of a mixture of research- and health-related information.

Furthermore, important questions need to be addressed, including: how to should we define the terms "individually identifiable" and "research information"?; what rules should govern patients' access to medical records about themselves?; should insurers or employers have access to individually identifiable health information without patients' authorization; and should Federal privacy regulations supersede state laws?

DHHS will soon release 150 pages of proposed regulations for public comment. The Health Insurance Portability and Accountability Act stipulated that the final privacy regulation should be completed by February 2000. Dr. Skirboll urged COPR members to read and comment on the DHHS proposed privacy regulation when it is issued for public comment.

In response to questions from the group, Dr. Skirboll explained that Congress has not yet enacted a health privacy law. Several bills have been submitted, with two principal privacy protections: (1) patient permission would be required before individually identifiable health information could be disclosed without a patient's permission, with some exceptions, and (2) patients would have access to his/her own individually identifiable health information, with few exceptions.

Dr. Skirboll also noted that stored tissue specimens themselves would not be covered by the proposed privacy rule. Only individually identifiable information about stored tissue specimens would be subject to the proposed rule.

In addition, it was also noted that the Shelby Amendment (revised OMB Circular A-110), which calls for public access to underlying research data through the Freedom of Information Act, will be implemented with safeguards for patient privacy and for proprietary data. NIH has also been looking at the costs of implementing the revised OMB Circular A-110 and the proposed privacy regulation, both in terms of monetary and non-monetary costs.

VII. Burden of Illness

Dr. Skirboll also reported on a June 28, 1999, meeting of experts convened to address the measurement of burden of illness (BOI). This meeting was part of the response to a recommendation from the IOM study on priority setting at the NIH. BOI was defined as a multidimensional concept that includes the adverse impact of illness, injury, or chronic conditions on the length of life and on the various dimensions of health, including physical, psychological and social functioning; impairments or pain; and perceptions of well being, concern, or worry. A focus on any single dimension of burdenBdeaths, number of cases or episodes, or health care expendituresBprovides an incomplete and misleading picture of disease burden. For NIH, a central question is how biomedical research contributes to changes in public health over time.

Summary measures of health have been developed which combine many dimensions of health into a single number for an individual or for a population. Summary measures can facilitate tracking trends in burden and comparisons of burden attributable to different conditions. They can be used to evaluate and compare the cost effectiveness of alternative clinical and public health interventions. To improve measurement of BOI, the expert group recommended establishment of a trans-HHS working group which could facilitate cooperation and determine what needs to be done and by whom.

A major criticism of summary measures is the inability to determine why a change in health in the population has come about. Models and related micro-economic research could help identify why a change in population health has come about. Models provide a framework to synthesize information from multiple data sets epidemiologic and demographic studies; clinical trials, national surveys of health status, health habits, health care utilization. The second recommendation of the expert group was to encourage the development of models for specific diseases and conditions. A first step would be to convene a workshop to explore the feasibility and value of models.

Dr. Skirboll pointed out that NIH already considers burden of illness in setting its priorities. The agency spends more than $500 million on activities which address various aspects of burden of illness. These activities include longitudinal studies, such as the well known Framingham Heart study; various recurring and one-time surveys; patient registries; and methodological research.

VIII. Future Activities and Interests for COPR

Dr. Varmus acknowledged that this meeting had included too much presentation and too little opportunity for dialogue. Several members who had attended NIH meetings did not have a chance to report on their activities, and others would have appreciated a chance to report on ideas and comments they had gathered from their constituencies. He promised that future meetings will have more time allotted to these presentations by COPR members. He also urged members to comment on the agenda in advance of the meeting, and to suggest topics that they would like to see on the agenda.

Members expressed interest in having an announced topic for future meetings, perhaps preceded by roundtable discussion on the night before the meeting. Alternatively, COPR members could volunteer to work on specific topics in advance of the meeting, for example by attending NIH committee meetings and workshops, and then report back to the group or give a commentary following the staff presentation.

IX. Adjournment

There being no further business, the meeting was adjourned at 4:00 p.m. on Thursday, October 21, 1999. The next meeting will be held on April 6 and 7, 2000.

Attachments:

• Council Roster: Attachment A
• List of Public Observers: Attachment B

Anne Thomas
Executive Secretary

These minutes will be formally considered by the Council at its next meeting, and any corrections or notations will be incorporated in the minutes of that meeting.

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