Director's Council of Public Representatives
Spring 2003 Meeting MinutesApril 24, 2003NIH Participants:
COPR Members Attending:
COPR Special Consultants:
NIH Director's ReportElias A. Zerhouni, M.D. Dr. Zerhouni welcomed all those present to the 9th meeting of the Director's Council of Public Representatives (COPR). He recognized the COPR Special Consultants, individuals who are expected to rotate onto the Council later this year. He reminded attendees that the meeting was open to the public and introduced Raynard S. Kington, M.D., Ph.D., newly appointed Deputy Director of the National Institutes of Health (NIH), who briefly addressed the meeting. Remarks of Dr. Kington Dr. Kington explained that the NIH Deputy Director provides oversight to the Office of the Director in scientific priority setting, strategic planning, committee appointments, and other activities that facilitate agency operations. He said the NIH faces many scientific, financial, and managerial challenges, and that his primary goal as Deputy Director is to help the agency more efficiently and effectively accomplish its scientific mission. Since his appointment in February, he has met with the Directors of NIH Institutes and Centers (I/C), and with representatives from external agencies, professional organizations, and the larger scientific community. He noted that the COPR plays an important role in ensuring that the NIH addresses the health issues most relevant to Americans, and that he looks forward to COPR input. Update from the Director Staff Changes Dr. Zerhouni welcomed the opportunity for new COPR members to meet some of the I/C directors and welcomed those who were present. He noted recent NIH staff changes, including the appointment of new I/C directors. These appointments include that of Nora D. Volkow, M.D., as Director of the National Institute on Drug Abuse (NIDA). Dr. Volkow previously served as Associate Director for Life Sciences, Director of Nuclear Medicine, and Director of the NIDA—Department of Energy Regional Neuroimaging Center at Brookhaven National Laboratory. She also served as a professor in the Department of Psychiatry and as associate dean of the School of Medicine at the State University of New York (SUNY)—Stony Brook. Other recent appointments include those of Thomas R. Insel, M.D., as Director of the National Institute of Mental Health (NIMH); T.K. Li, M.D., as Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA); and Roderic I. Pettigrew, M.D., Ph.D., as Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). Efforts are underway to fill vacancies at the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of General Medical Sciences (NIGMS). Changes in the NIH Office of the Director include the departure in December of Wendy Baldwin, Ph.D, former Deputy Director for Extramural Research. Dr. Baldwin left the NIH to accept a position as vice president for research at the University of Kentucky. Belinda Seto, Ph.D., now serves as Acting Deputy Director for Extramural Research. Additional changes include the appointments of Mark Rohrbaugh, Ph.D., J.D., as Director of the Office of Technology Transfer; Mr. Don Poppke as Associate Director for Budget; and Mr. John Burklow as Associate Director for Communications. Noteworthy Events On April 14, 2003, the NIH celebrated the landmark completion of the human genome map, President Bush visited the NIH on February 3, touring the Vaccine Research Center and delivering an address at the Natcher auditorium. He expressed appreciation for the NIH's work, particularly in the biodefense area. Project BioShield, for example, is a comprehensive effort to ensure access to modern, effective drugs and vaccines to protect against biological and chemical attacks. The NIH has responded to the president's biodefense agenda by expanding research strategies for chemical, nuclear, radiological, and psychological biodefense. The NIH also has formed a Biodefense Committee to oversee such research and define a strategic plan. Dr. Zerhouni formed a Stem Cell Task Force when he became NIH Director. The task force has worked with the scientific community for many months to identify roadblocks, challenges, and opportunities in stem cell research. A June 12th symposium will summarize the state of the science and research challenges. Director's Formal Presentation Dr. Zerhouni began his formal presentation by noting that the NIH is the foremost federal agency conducting, supporting, and stimulating biomedical research in the United States. NIH supports the largest concentration of biomedical researchers in the world who are committed to public health emergencies and rare diseases that are not addressed elsewhere. Dr. Zerhouni reviewed the allocation of the NIH budget, emphasizing that the agency's research program is competitive and self-adapting. Of the country's $54–$57 billion investment in civilian, nondefense research, the NIH makes up about 47 percent, or approximately $25.4 billion. In 2002, extramural research accounted for 84 percent of the NIH budget. Less than 4 percent of NIH grantees have had ongoing grants for more than 20 years. Only about 50 percent of renewal applications are granted. About 10 percent of the NIH budget is spent on intramural research, which includes programs housed at the NIH and conducted by NIH scientists. About 3 percent of the NIH budget is used to manage and support in-house research programs, and the remaining 4 percent goes to the National Library of Medicine for information sharing and dissemination as well as the Office of the Director, and NIH facilities infrastructure. Several offices within the NIH Office of the Director (OD) have their own budgets. These include the Office of AIDS Research, the Office of Research on Women's Health, and the Office of Behavioral and Social Sciences. These programmatic offices are not designated as intramural or extramural research entities. Historically, some of these offices—for example, the former Office of Minority Health and Health Disparities—become Centers over time. Dr. Zerhouni presented a graph showing changes in the NIH budget between 1970 and 2000. In 1970, the Federal Government supported more than 80 percent of biomedical research. Today, it supports about 50 percent. This change is not due to a decreased federal investment—the NIH budget increased during this time and will double over the next five years. Rather, the change is due to greatly increased investment by others, particularly the pharmaceutical industry, in biomedical research. Spurred by Federal investments in the 1970s, such industry investment surpassed that of the NIH in 1991 and now grows at a commensurate rate. Biomedical research is also a top priority for the 21st century among scientific foundations, philanthropies, and academic institutions. Science itself is changing as a result of discoveries in proteomics and molecular biology, becoming increasingly multi- and interdisciplinary. Expertise from many disciplines is required to address the scope, scale, and complexity of biological research today. Academic faculties also reflect the changing nature of science. The number of Ph.D. faculty in universities will have increased from 18,000 in 1990 to 27,000 by the end of 2003, and the majority are in clinical science departments. These trends reflect a growing understanding that biomedical research today requires multidisciplinary teams with multiple skill sets. The recent doubling of the NIH budget enabled the NIH to expand its grant pool by about 37 percent, from about 27,000 in 1998 to 37,000 in 2003. This number will be even higher by the end of 2004 and ultimately will increase by 45–50 percent. The number of grant applications received each year has grown by 46 percent. The 30 percent success rate of applicants is expected to remain about the same. Dr. Zerhouni then discussed megatrends and the challenges that will affect the NIH as the landscape of the U.S. health care system evolves. Most prominent among these trends is a shift in emphasis from acute, lethal diseases to chronic, long-term diseases. In many cases, this shift has resulted because research advances have increased the survival times of patients suffering from lethal conditions such as AIDS. Chronic diseases constitute about 75 percent of the national disease burden. Other contributing factors are the aging population, health disparities, emerging diseases such as severe acute respiratory syndrome (SARS) and West Nile virus, and the newly significant health concerns related to biodefense. An example of the shift from acute to chronic disease is the increased survival rate of patients who have coronary heart disease (CHD). The age-adjusted CHD death rate has declined by nearly 60 percent in the past 50 years. AIDS, another major health burden with increasing rates of long-term survival, has benefited from the development of 80 new drugs and a 3-fold increase in the number of vaccines in Phase I trials since 2001. Dr. Zerhouni emphasized the need to regularly review the NIH research portfolio to assure it is appropriately diversified and it addresses future challenges. For example, we know the population is aging, and we know the top six disability-causing conditions among older adults—arthritis and other musculoskeletal disorders, heart disease and other circulatory conditions, vision and hearing problems, fractures and joint injuries, diabetes, and mental illness. Thus, as life expectancy increases, we need to consider research strategies that can prevent or delay those age-related diseases and disabilities. Reducing health disparities is a priority and a challenge. Although progress has been made in many diseases among minority populations, such as heart disease among black males, health differences and disparities persist. Dr. Zerhouni noted the importance of looking not only at the current burden of disease, but also downstream to the future implications of current trends. For example, rates of obesity and diabetes are increasing among U.S. adults and, if they continue to rise, will constitute an enormous health burden. Compared to the relatively slow growth during the years 1994–1999, national health expenditures in the United States have increased at an accelerated rate in more recent years, and between the years 2000 and 2011 they are projected to more than double. Consequently, national health care expenditures as a percentage of GDP are projected to increase from 13.1 percent of GDP in 2000 to 17.0 percent of GDP in 2011). If this growth curve continues at its present rate, there may be no room in the budget for research. Dr. Zerhouni detailed three major themes of the NIH Road Map Initiative, which identifies scientific challenges and roadblocks to progress and indicates directions for future research. The first is the development of new pathways to discovery. The genomic era offers unprecedented opportunities for understanding biological systems. Novel approaches must replace outdated reductionist views of disease. A new view is that disease arises from multiple factors; this view requires an understanding of biological disease pathways and their controls and interactions. Future research will require investment in new technologies, bioinformatics, and molecular libraries. Advances in novel research methodologies, such as biomedical imaging, also are needed. The second theme of the NIH Road Map is to promote research teams of the future whose scale and complexity will require new organizational models for team science. Research teams of the 21st century must be large, coordinated, multidisciplinary, and resource sharing to preserve investigator-initiated strategies. The third theme is a re-engineering of the clinical research enterprise. The nation needs a common research informatics base, training that is more cohesive, national networks to improve the effectiveness and efficiency of research, efforts to harmonize the many regulations while maintaining human subjects protections, approaches to measure clinical outcomes and improvements in translational research. The goal is to develop a more efficient, national, bench-to-bedside clinical research system. Dr. Zerhouni concluded that, if not addressed, the rapidly changing nature of health care and the challenges facing young researchers could threaten the discovery process. The plan for the NIH is to continue to gather the best ideas and the best and brightest people, and ensure adequate resources to meet these challenges. Comments and Discussion Ms. Tetenbaum noted the importance of NIH brainstorming and think tank activities as an integral part of the discovery process, asking for comments on how such exchanges take place. Dr. Zerhouni said that each I/C organizes such activities in accordance with its mission. In addition, the Office of the Director (OD) holds weekly information-exchange meetings, and 21,000 people advise the NIH each year. This has been deemed the most effective and open approach to strategizing for the NIH's future. Dr. Mala inquired about the NIH role in public and international health emergencies, such as the SARS outbreak in China. Dr. Zerhouni said that several NIH programs are designed to quickly identify and respond to emerging disease outbreaks. For example, the causative agent of SARS was originally identified by an NIH grantee in Hong Kong who was a member of an Asian-flu-tracking network. Once it was recognized that SARS was a new virus, the Centers for Disease Control and Prevention (CDC) began investigating. With a gene array of viruses available at the NIH, scientists were able to identify the genetic structure of the SARS virus. Dr. Sigal complimented Dr. Zerhouni on the stewardship of the NIH budget and his strategic planning initiative. She observed that the NIH budget seems relatively static in an era of big science and wondered about flexibility within the budget to fund new research areas. Dr. Dunston asked about the mix of dollars for behavioral versus medical research. Dr. Zerhouni explained that an estimated 10 percent of the NIH budget is committed to behavioral research. At the same time, increasing numbers of research teams are integrating behavioral science in their pool of expertise. In addition, several I/Cs are developing new initiatives in behavioral research and view it as a core part of their work. Dr. Grant said she was glad to see that heart disease in women is a research priority in the NIH portfolio. She noted a recent NIH conference on the topic and described an article in the New York Times about differences between randomized clinical trials and observational studies. She also asked about NIH self-evaluation mechanisms to determine whether outcomes are being met. Dr. Zerhouni explained that outcomes evaluation at the NIH is a multi-tiered process. Institute Directors are reviewed every 5 years as are intramural Scientific Directors. External Boards of Scientific Counselors review intramural researchers every 4 years. In addition, the NIH works with the Office of Management and Budget (OMB) to meet requirements of the Government Performance Results Act (see Dr. Skirboll's presentation for details). Other measures include naming an ad hoc blue-ribbon panel to evaluate the intramural clinical research program. Dr. Hall asked about the status and progress of the National Clinical Research Program. Dr. Bromet asked about the NIH's international relationships and partnerships. Dr. Zerhouni described his participation in the Heads of International Research Organizations, which meets twice yearly, once in Europe and once in the United States. Representatives of major industrialized countries attend to discuss coordination of policies and integration with the World Health Organization (WHO) programs. Dr. Zerhouni said he believes the most fruitful international interactions take place between individual scientists. Dr. Keusch explained that the NIH is unique in its acceptance of research proposals from around the world. Many universities that conduct NIH-supported research are engaged in collaborative projects with institutions abroad, and this is an increasing part of the NIH budget. NIH gives strong consideration to global health disparities and developing countries, investing not only in research but also in building research capacity. As an example, Dr. Keusch described the Fogarty International Center Multilateral Initiative on Malaria, initiated in 1998 by International relationships and partnerships are an important part of the NIH mission. The agency spends about $300 million on international research and works with the Pan American Health Organization, WHO, the Gates Foundation, and others. The NIH also has a visiting scientists program and contributes about 40 percent of the international research budget to global research and development. The influence of such collaborations exceeds dollars spent. Dr. Torres Mughal asked about health disparities in relation to data being collected on subgroups in minority populations. As an example, she cited the demographics of Pacific Islanders, whose makeup has changed significantly in recent years. She asked about the amount of money spent by the NIH on research for these groups, and how to make research a priority in a developing country where hunger and poverty are overriding problems. Dr. Zerhouni said that, in global terms, addressing hunger and other basic needs could eclipse spending money on research. However, research can become a mechanism by which a country creates the intellectual capital and capability it needs to handle such problems. Global health disparity is of great concern because of its potential to lead to fundamental disruptions worldwide. Addressing the first question, he said that, domestically, the quality of data on subgroups in minority populations varies, partly because of the extraordinary range of differences in minority subgroups. He said there is a need to move away from the simplistic approach of taking a single snapshot of a subgroup. Dr. Kington added that substantial data have been collected on African Americans but, even in this largest subgroup, differences are created by an increased influx of immigrants. He said the quality of data on Hispanic subgroups is reasonable but data on Asians/Pacific Islanders are inadequate. Dr. Browne asked for further information on NIH capacity-building initiatives, globally and in domestic minority populations. Dr. Zerhouni said three areas are important to capacity building and eliminating health disparities: increasing the representation of minorities in research, cultural competence, and cultural tailoring of health messages. He described an NIH initiative to help African American, and now Hispanic, students become biological scientists and build an infrastructure of African American colleges and universities. In 1972, when the Department of Health, Education, and Welfare oversaw the project, the NIH brought new faculty to participating schools. Today, many students in those colleges and universities major in the biological sciences. Dr. Kington also described the Minority Supplement Program, which provides administrative funds for research projects to support high school students, undergraduate students, and faculty. The purpose of the funding is to add staff members to NIH grants who could eventually become independent investigators. Mr. Sadwin asked for an update on the NIH restructuring being reviewed by the Institute of Medicine (IoM). Dr. Zerhouni reported that a policy decision was made at the NIH that "it is more important to preserve people than bricks and mortar." He said the NIH wants its research community to understand the agency's commitment to their future. He added that the IoM restructuring committee is now writing the report it must deliver by next year. Senator Jensen asked how the Government facilitates the process by which discoveries are translated into practice. Dr. Zerhouni observed that the first stages of clinical trials are fairly quick, consisting of toxicity studies. The next stages, which involve thousands of patients and are the point at which the regulatory process comes into play, are slower. The slower pace is due less to government regulation than to the scientific complexity of research at this stage. The NIH is trying to work with the Food and Drug Administration (FDA) to better integrate the discovery and regulatory processes. Ms. Butler asked about continued funding of basic research, the recruitment of young M.D. investigators, and whether pressure to move discoveries from bench to bedside affected basic molecular biology research. Dr. Zerhouni noted that the research portfolio must be balanced with continued investment in basic research. There is also a need to accelerate the investment in systems. For instance, pharmaceutical industry researchers use systems with an array of targets, allowing more efficient identification of those that are effective. It is important for the NIH to have a balanced, proactive, and prospectively determined portfolio that relates to strategic areas in health. Dr. Bromet noted that the number of young M.D. investigators has dwindled over the past 20 years. Dr. Zerhouni said that he sees the root of the problem as being disincentives in the current research enterprise. Training for clinical research, for example, is fragmented. Emerging leadership among young M.D.s needs to be encouraged. Presentation on the National Institute of Alcohol Abuse and AlcoholismT.K. Li, M.D., Director, NIAAA Dr. Li explained that the NIAAA provides leadership in the national effort to reduce alcohol-related problems by conducting and supporting research in scientific areas that include genetics, neuroscience, epidemiology, health risks and benefits of alcohol consumption, and alcohol-related problem prevention and treatment. The NIAAA collaborates and coordinates with other research institutes and Federal programs on a range of alcohol-related issues. The Institute also collaborates with international, national, state, and local institutions, organizations, agencies, and programs engaged in alcohol-related work. NIAAA research findings are translated and disseminated to health care providers, researchers, policymakers, and the public. The NIAAA vision is that research and education will remove the stigma associated with the disease of alcoholism. The effects of alcohol consumption are known to vary among individuals, and research will reveal the genetic, biological, and sociocultural origins of these variations. Prevention and treatment of alcohol-related problems address physical, behavioral, and social risks attributable to excessive and underage alcohol consumption, and the chronic relapsing and remitting nature of alcoholism. Dr. Li described NIAAA outreach efforts, beginning with the Web site (www.niaaa.nih.gov), which is visited by about 800,000 people each month. Of primary interest to visitors are NIAAA publications and the frequently-asked-questions link. Publications include pamphlets and other materials for the public and the scientific community. April is Alcohol Awareness Month, and National Alcohol Screening Day (NASD) was April 10, 2003. This activity is sponsored by the NIAAA, the Substance Abuse and Mental Health Services Administration (SAMHSA), and Screening for Mental Health, Inc. The NASD program provides free, confidential, educational screening and brief intervention at sites that include hospitals, primary care physicians' offices, clinics, military installations, and community settings. The sites offer educational publications for consumers and care providers. Brief intervention ranges from advice about reducing drinking to recommendations for formal treatment programs. This activity is increasingly important for several reasons: research shows that 36 percent of the U.S. population older than age 18 exhibits risky drinking behavior related to alcohol consumption quantity and frequency, and alcohol screening still is not a part of routine practice in health care delivery, although screening and brief intervention are known to effectively reduce harm. This year there were more than 4,500 NASD registration sites in all 50 states. Fundamental questions addressed in alcohol research are why some people drink while others do not, why some drink more than others, and why some drink excessively despite negative consequences. To understand the etiology of alcohol problems, researchers examine genetic and other biological and sociocultural origins of varying responses to alcohol. Based on answers to these questions, researchers seek to develop effective treatment and prevention strategies, address the physical behavior and social risks attributable to excessive and underage alcohol consumption, and understand the chronic, relapsing nature of alcoholism. Alcohol problems are related to drinking quantity and frequency and to underage drinking. A standard drink consists of one beer, one glass of wine, or one shot of liquor. Binge drinking is popularly defined as the consumption on one occasion of five or more standard drinks for men and four or more drinks for women. Underage drinking is a problem in the United States. In a recent survey, 11 percent of 6th graders and 30 percent of 12th graders reported binge drinking, and 21 percent of 8th graders reported having been drunk at least once. Adolescents who begin drinking at an earlier age have been shown to have smaller hippocampal volumes. Memory problems are common among adolescents in treatment for alcohol detoxification. An NIAAA epidemiological study showed that age at drinking onset influences the later development of alcoholism. Those who start drinking at age 13, for example, are four times more likely to become alcoholics than those who start at age 18. The Leadership to Keep Children Alcohol Free program is a public-private, federal-state initiative that is part of the NIAAA's efforts to address underage drinking. Co-founded by the Robert Wood Johnson Foundation, it is the only national initiative that focuses on preventing alcohol use by children ages 9–15. Collaboration and support for the program is provided by other Federal agencies, including SAMHSA, and by NIH Institutes. The program provides research evidence to governors' spouses to support state outreach and education activities. Forty states participate in the program. This new research-based initiative will address underage drinking in a community context from childhood through college. The program will help test new research hypotheses and build community research, prevention, and treatment capabilities. It will support partnerships with leaders in academic health centers, public health arenas, local communities, and educational settings. The result will be well-tested, cost-effective, multifaceted strategies for addressing underage drinking. Comments and Discussion Dr. Grant asked about the status of fetal alcohol syndrome (FAS) research. Dr. Li reported that research has shown that FAS, the leading preventable cause of juvenile retardation, is more related to binge drinking than to constant low-level drinking by pregnant women. The prevalence of FAS is high among Native Americans, and research in this group is a high priority in the NIAAA portfolio. The Institute also supports FAS research in other populations. One study showed that the prevalence of FAS among vineyard workers in Cape Town, South Africa, was 1 in 60–1 in 100, due to cultural and genetic factors. Dr. Bromet asked about NIAAA co-funding with other Institutes. Dr. Li said cofunding is an effective way to implement programs, especially in a time of budget restrictions; for example, similar research groups from each Institute could join forces to procure and share expensive equipment. NIAAA co-funding efforts deal with high-risk behavior in general to identify comorbidities that can exist with alcohol-related problems. Such associated behaviors may include early sexual activity, tobacco use, conduct disorder, and antisocial personality disorder. In the Leadership to Keep Children Alcohol Free initiative, the NIAAA agreed to be a partner in the Transdisciplinary Research Initiative cofunded by the National Cancer Institute and NIDA. Ms. Butler asked about NIAAA programs for addressing alcohol problems in pediatric and older populations. Dr. Li said the NIAAA supports the need to address alcohol-related problems in all age populations. The NIAAA is developing ways to provide advice about harm reduction to pediatricians and others, and is developing literature for use by social workers, pediatricians, and primary care physicians. Ms. Tetenbaum commended Dr. Li and Dr. Calhoun, NIAAA Associate Director for Collaborative Research, on the toolkit provided to COPR members for drinking among college-aged youths. She emphasized the importance of delaying the onset of drinking in children and asked about outreach methods used in the Leadership to Keep Children Alcohol Free program. Dr. Li replied that the research evidence provided to governors' spouses was the first step in reaching out to other state programs. It will also be important to establish partnerships among researchers, states, and communities. Ms. Tetenbaum asked whether FAS statistics have changed since it was first identified. Dr. Li said it is difficult to detect changes in FAS incidence because studies that use intervention and control groups show changes in drinking patterns of the control groups. This suggests that the intervention has an effect even on the group not receiving it, perhaps by raising subjects' awareness of drinking levels. Dr. Mala noted the impact of alcohol consumption and alcohol-related problems on Native Americans and inquired about the status of research on an alcohol dehydrogenase gene. Dr. Li said this gene seems to protect against heavy drinking and is not present in Native Americans, possibly because their ancestors were from Siberia. He cited the need for more research in this area. In response to Dr. Mala's suggestion that members of minority medical associations be included on NIAAA review boards, Dr. Li said the work of these coalitions is very important and the Institute would be happy to work with them. Dr. Sigal asked about public service campaigns targeting children more specifically. She inquired whether efforts are under way to involve media experts in reaching younger audiences. Dr. Li noted that no advocacy group currently focuses on underage drinking. A pilot study would help demonstrate the feasibility of reaching children through community organizations and schools. It is important to involve media experts early in this process. Dr. Tamura also praised the toolkit and requested an overview of the NIAAA strategic plan for addressing health disparities. Dr. Li said NIAAA researchers are acutely aware of the importance of understanding that alcohol use and abuse is intimately tied to cultural aspects of drinking practices. Gender differences are also important. Such research is a major part of the NIAAA portfolio. Culturally appropriate messages are also important, and the NIAAA has worked in this area with Hispanic populations. Similar efforts are in development for Asian populations. Another NIAAA program is directed at African Americans in the Washington, DC, area and focuses on FAS prevention. Ms. Buelow asked about programs for children of alcoholics. Dr. Li said this is one of the NIAAA's highest priorities. The problem is difficult because, although alcoholism affects approximately one-quarter of American families, not everyone with a positive family history develops alcohol problems. Identifying a trait marker for alcoholism is a high NIAAA research priority. Dr. Torres Mughal noted an apparent disconnect between research on the hazards of alcoholism and the way the public perceives drinking, partly due to mixed public health messages about alcohol consumption. For example, the fact that low alcohol consumption levels can improve lipid profiles may be misinterpreted as meaning that drinking alcohol is beneficial to health. Consistent, clear messages are needed and education in school curricula is important. Presentation on the National Institute of Biomedical Imaging and BioengineeringRoderic Pettigrew, M.D., Ph.D., Director, NIBIB Dr. Pettigrew's presentation emphasized the importance of technological innovation in advancing scientific discovery. Biomedical research is becoming more interdisciplinary and synergistic. Part of the NIBIB mission is to find the optimal interface between the physical sciences and the fields of biology and medicine. Signed into law on December 29, 2000, by President Clinton, the NIBIB is the result of combined efforts by the biomedical and bioengineering communities. The Institute has a 40-member staff and, at the time of this presentation, administers 650 funded grants totaling about $250 million. The NIBIB issued 10 Requests for Applications (RFAs) in its first 6 months and received a very robust response. The NIBIB research portfolio includes cellular and molecular imaging, nanotechnology, image-guided interventions, tissue engineering, bioinformatics, biosensors, biomaterials, telemedicine, 3D tomographic imaging, optical imaging, computation biology, and interdisciplinary training. Dr. Pettigrew offered several examples of this work. In the area of imaging at the cellular level, researchers have developed a smart probe for cancer. A molecule is configured in such a way that the chemical bond prevents light from being emitted in the infrared range. In the presence of a protease that resides on cancer cells, the bond is lysed and light is emitted, indicating the presence of cancer. Cardiovascular disease is a major cause of morbidity in the United States. A persistent challenge is to detect it early enough to prevent heart attack and stroke. Another molecular imaging technique uses nanosize particles targeted against fibrin, a key agent in the development of heart attack and stroke. In the areas of bioengineering and tissue engineering, Dr. Pettigrew showed a photograph of a scaffolding-type construct to promote wound healing in burn victims. The construct contains cellular growth factors to promote wound healing. Over time this technology may be applied to the development and replacement of critical subunits of severely diseased organs. He also showed a brief movie about advances in developing prosthetic limbs. The example showed an intelligent prosthetic knee containing sensors that allow it to respond and flex like a normal knee. In the area of bioinformatics, Dr. Pettigrew described a brain-computer interface system that allows paraplegics or quadriplegics to operate computers and simple prosthetic devices. In the area of cellular modeling, the NIBIB, in collaboration with the NIGMS, is conducting research to understand cell-signaling pathways. This research may one day lead to computer modeling to evaluate cell behavior under a variety of conditions to evaluate disease and the impacts of various interventions. The NIBIB is also engaged in research on image-guided interventions. Magnetic resonance imaging (MRI) of tumors in rat models is being used to reveal areas that contrast agents do and do not enhance. Microarray technology showed different levels of gene expression in enhanced and non-enhanced areas of the tumor. These experiments have indicated that tissue in tumor masses is not homogeneous, not only from one patient to another, but also within the same tumor mass. This information can help guide therapies modeled on genetic behaviors. Intravascular catheterization is an emerging technology that allows in vivo visualization inside arteries. Early detection of plaque accumulation may one day make it possible to treat localized areas by injecting chemical agents or by using gene-based therapy to reduce or stabilize the plaque, circumventing a catastrophic event such as a heart attack or stroke. Three-dimensional imaging techniques increasingly are used in operating suites. Neurosurgeons can view 3-dimensional images during surgical procedures to obtain important information about incision locations and stimulator placement. Dr. Pettigrew showed a brief movie demonstrating the effect of a stimulator placed in the brain of a Parkinson's disease patient who could then walk normally. This technology also yields new information about brain function. In summary, Dr. Pettigrew reviewed the important areas of NIBIB-supported research, including biosensors, tissue engineering, drug and gene delivery systems and devices, and micro- and nanotechnology. He concluded with two slides showing a microelectronic motorized system and a device that will be able to detect the presence of viruses in an air sample. NIBIB's guiding principle is to pursue technologies whose application will yield new discoveries and advance disease understanding, prevention, and treatment. Comments and Discussion Dr. Muñoz asked about the screening potential of technologies used to detect vascular disorders. Dr. Pettigrew said the cost-benefit ratio of such technologies is an important factor. The accuracy and expense of such tests would be major considerations in using the technologies for screening. Dr. Sigal asked about opportunities for collaboration with industry, given the large industry investment in many of the technologies described. Dr. Pettigrew said there are synergistic opportunities for collaboration with industry and he hopes to be able to report on such activities by next year. Dr. Mala noted the potential importance of telemedicine in remote areas such as Alaskan villages. He noted that the Centers for Medicare and Medicaid Services reported that the primary use of telemedicine has been in radiology and psychiatry and asked about potential new areas for applying the technology. Dr. Pettigrew said one of the earliest applications was in geographic areas where expertise was needed to interpret images and that the technology can be used in areas where specific expertise or equipment is lacking to consult with experts. An exciting advance that may hold promise is the development by the National Aeronautics and Space Administration of a robonaut with manual dexterity similar to that of a human. It may one day be possible to couple this technology with a global positioning system so that, in areas where specific surgical expertise is not available, sensors on a surgeon's hand can direct the movements of a surgical robot to perform surgery at the remote site. Update on the Government Performance and Results ActLana Skirboll, Ph.D., Associate Director for Science Policy, NIH Dr. Skirboll began her presentation with a brief history of the Government Performance and Results Act (GPRA) and a summary of decisions made at the NIH to comply with its requirements. The GPRA was passed in 1993 with three main goals: to improve program management, effectiveness, and accountability by focusing on results; to improve congressional decision making and affect budgets; and to improve public confidence in government. The GPRA generated much discussion and debate in the NIH scientific community. Of primary concern was that goal setting in science is different than in other institutions because of the inherent unpredictability of science. It was considered important to devise a planning process for GPRA compliance that did not hinder scientific creativity or discovery. The resulting plan consists of three broad areas that encompass the NIH budget: the research program, research training and career development, and research facilities.1 Under these categories, goals are set for research outcomes and for communicating results, technology transfer, grants administration, peer review, management, training, and buildings and facilities. The previous method for evaluating outcomes and goals was qualitative. The new goals must be representative, meaningful, specific, objective or quantitative, reportable, and not obviously attainable. Goals are set and placed in a matrix that represents a continuum of the time to achieve the goal and its level of difficulty (i.e., low to high risk).
The ICs submitted a total of 240 goals. Ultimately, 27 scientific research outcome goals were selected for inclusion in the GPRA Plan/Report that was published in February 2003. It presents a clear picture of how the NIH does its work—what goals have been set, what progress has been made in attaining them, and which goals have been met. Dr. Skirboll referred those present to the NIH GPRA Plan/Report for examples of goals submitted with the current year's budget. One goal is as follows: "By 2006, develop one or more prototypes for a low-power, highly directional hearing aid microphone to help hearing-impaired persons better understand speech in a noisy background." This goal meets the criteria of being specific, meaningful, and observable, and falls into the categories of intermediate risk and short time frame (1–3 years). A high-risk, longer-term (4–6 years) goal is: "By 2007, develop an HIV/AIDS vaccine." Non-research components of the NIH GPRA Plan are also being aligned with GPRA requirements. These include communication of results, technology transfer, grants administration, agency management, training, and buildings and facilities. The plan describes goals in each area that are also placed in a matrix. Dr. Skirboll then described President Bush's Management Agenda, overseen by the OMB, which tracks how federal agencies are managed and ties this to performance and, ultimately, budget. GPRA research outcome goals are part of the agenda, as are two other activities. The first is research and development criteria being developed by the Office of Science and Technology Policy. The second is the Program Assessment Rating Tool (PART), which consists of assessments for each type of federal agency activity. For purposes of the FY 2005 PART, the NIH will be assessed under the Research and Development. With these tools, the OMB evaluates program performance and gives each agency a weighted score. GPRA goals are broadly linked to the NIH budget because most are trans-NIH with no single budget line and many sources of funding across the Institutes and Offices. The process of planning and goal-setting can be likened to that of Lewis and Clark, who, when requesting funding for their expedition from Congress, did not promise what they would discover but proved that they could plan for the trip. The GPRA plan is similar in that it relies on concrete goals to equip the process of discovery. 1Since the time of the presentation, NIH has streamlined its GPRA program planning and reporting. Every activity at NIH is carried out under one program—Research—in support of NIH's single mission: To uncover new knowledge that will lead to better health for everyone. To achieve the best possible scientific results, NIH carries out research activities in five functional areas: Scientific Research Outcomes, Communication and Transfer of Results, Capacity Building and Research Resources, Strategic Management of Human Capital, and Program Oversight and Improvements. Comments and Discussion Mr. Armstrong asked how often the list of goals is updated. Dr. Skirboll said the list will be evaluated annually and the total number will vary accordingly. Every year, as part of the budget process, these goals are included as part of the NIH congressional justification. Dr. Sigal asked what percentage of the NIH budget is devoted to the goals. Dr. Skirboll said the GPRA Plan is more reflective of the kinds of basic and clinical research performed at the NIH. The plan therefore does not require that the goals constitute a certain percentage of the budget. As a follow up, Dr. Sigal asked about the response from the OMB to the NIH GPRA Plan. Dr. Skirboll said the OMB and Congress have responded positively about the NIH's willingness to set such goals, and enabled NIH not be rated until FY 2003. She is hopeful the agency will continue to be well rated as the goals are put in place and OMB conducts its evaluation on the AIDS program. Dr. Zerhouni offered clarification by explaining that, before the GPRA passage, the NIH set five qualitative research outcome goals so broad that one area or another would always be successful. A tool for aligning goals, strategic plans, and operational plans was lacking. Because it was not possible to look at every NIH program, a sampling methodology was used: a few Institutes were examined in depth, and goals were chosen that cut across all NIH competencies. As a result, many goals were identified that could be stratified according to the time needed to accomplish them and the level of risk (difficulty) involved in meeting them. An example of a low-risk, short-term goal was to create a map of the human genome by 2005. A negative aspect to this approach is that some may wonder about the inclusion of specific diseases. When the goals are examined in combination, however, together they test all aspects of the NIH. Dr. Zerhouni said COPR input was critical to this process. Report on the NIH Communication PlanMr. John Burklow, Associate Director for Communications, NIH Mr. Sadwin introduced Mr. John Burklow, recently appointed Associate Director for Communications, who developed an NIH Communications Plan to ensure clear, consistent, and integrated communications across the agency to provide a clear perspective when communicating with public audiences. Mr. Burklow began his presentation with results from a survey showing that only about six percent of Americans know what the NIH does. At the same time, those surveyed were highly supportive of scientific and biomedical research. The benefits of strategic communication include conveying the relevance of medical research and the NIH leadership role to audiences ranging from policymakers to the public. Another important goal is to demonstrate accountability for the public's continued investment in medical research. NIH's impact as the world's foremost health institution can be maximized by coordinating I/C communications about medical research discoveries that touch people's lives. It is also important to reinforce in the public audience the link between the NIH and the Department of Health and Human Services (DHHS). The goal of the NIH communications plan is to convey to the public how NIH-supported research helps improve health. The objective is to enhance public awareness of the NIH as a trusted, credible source of health and medical information. Intended audiences include direct and gateway audiences. Examples of the former are the public, minority and underserved populations, patients and their families, health care providers, science opinion leaders and policymakers, and scientists and students. Gateway audiences include the media; scientific, professional, and academic organizations; voluntary health organizations; and NIH staff. Strategies for implementing the plan include working with the NIH Office of the Director and the I/Cs to develop clear, consistent, and integrated communications; conducting proactive media outreach to communicate NIH messages to the public; and undertaking collaborations with science, medical, voluntary, and private organizations to engage their members and the interested public. A first step in implementing these strategies is improving and widely distributing the NIH home page. A new NIH brochure is currently awaiting DHHS approval and will soon be finalized. Next steps for the first strategy include developing policy guidelines on consistent identities for the NIH and DHHS, developing a speaker's kit and traveling exhibit to tell the NIH story, and enhancing grantee communication about NIH support. Action steps in the second strategy include conducting outreach to top-tier media such as prominent newspapers, radio and television news programs, scientific publications, and journalist associations. These media will present opportunities for developing television programs and documentaries about medical research. The NIH will develop a regular health segment for radio stations. As part of the third strategy, arrangements will be made for NIH leadership to deliver keynote addresses at national conferences of voluntary and professional organizations. Partnerships will be pursued with outside organizations to develop an exhibit about the NIH. Other activities include establishing an NIH e-newsletter and enhancing activities of the Offices of Public Liaison. Mr. Burklow explained that the approach to developing the NIH communication plan consists of situational analysis, planning and programming, implementation, and evaluation. Between December 2002 and March 2003, a needs assessment and an environmental scan were completed to assess how the NIH affects public understanding of medical research. The assessment included analyzing media coverage and use of the NIH Web site, evaluating NIH products, and conducting focus groups and an awareness and attitude survey. In a survey of internal stakeholders, I/C directors and staff were asked to describe the NIH role, its unique contribution, and attributes that should be communicated to various audiences, including the public. According to these stakeholders, the NIH role was to conduct medical research that led to disease detection, treatment, or prevention, or that improved health. They cited improving health and supporting and funding research as important attributes that should be communicated. The unique NIH contribution was seen as its ability to conduct research without a financial or profit motive. In a survey of external stakeholders, COPR members and directors of communications, public affairs, and public relations offices in professional and voluntary organizations and universities were asked to describe the NIH role and how its activities benefited the public, and to identify three health priorities that the NIH should address. These stakeholders also said the NIH role was to conduct medical research that led to disease detection, treatment, and/or prevention. They believed that NIH activities benefited the public by improving health and preventing and curing disease. They were more likely to identify specific diseases such as cancer, cardiovascular disease, and HIV/AIDS as NIH health priorities. Outside organizations were more likely to have contact with individual I/Cs rather than with the NIH as a whole. They welcomed more frequent communication from and with the NIH, preferably via electronic communication or in-person meetings, and prepackaged information describing the broader implications of research findings. The environmental scan indicated that, although the NIH is known for conducting research, its leadership role and direct benefits to its target audience are generally not communicated. The name "National Institutes of Health" or "NIH" often comes up on the topic of medical research or studies, but the agency is typically mentioned only briefly as the research funder. Many I/Cs are mentioned without affiliation to the NIH. When the news media report on scientific discoveries, they are more likely to mention the institution conducting the research than NIH as the funding source. An analysis of NIH media coverage showed that news stories on medical research mention the NIH only briefly. NIH-referenced stories cover a variety of health topics but quote mostly non-NIH affiliations, usually an academic institution. The abbreviation "NIH" is also rarely defined in news stories. An analysis of NIH Web site use showed people search it primarily for disease-specific information. The site is visited more often than those of the CDC, the FDA, or the DHHS. In NIH publications and other products, communications staff found that more than half the I/Cs clearly identified themselves as part of the NIH, although they did not describe the agency in their publications or Web sites. Most I/Cs use some combination of NIH, DHHS, and/or individual I/C graphic logos. Members of consumer focus groups thought medical research was very important and should be increased. They viewed the personal benefits of medical research as including "improved quality of life" and "longer and healthier life." Some terms were more familiar to the public than others; for example, most people were unsure of the meaning of "biomedical," although they recognized the term "medical." Most people were unfamiliar with the term "basic research," and most were less familiar with the NIH than with the CDC or FDA. Mr. Burklow said that an important lesson learned from these activities was that, in the public's mind, the NIH is not positioned as a cohesive entity with a single voice. Although this is not always achievable, given the diversity of I/Cs, more could be done to this end. Immediate next steps are to develop an operational plan and develop and institutionalize guidelines for enhancing the NIH identity. Refining NIH messages will involve examining the consistency of agency communications with the public and other audiences about its activities. A traveling exhibit and media training should be made widely available to NIH scientists. Comments and Discussion COPR members advanced many ideas for the communications plan and next-step strategies.
Dr. Zerhouni noted that these ideas would fit well into a GPRA-like matrix, and that the communications strategy could be a COPR work group topic. COPR Work Group Co-Chair Reports and DiscussionDr. Zerhouni and COPR Members Mr. Sadwin, co-chair of the COPR Agenda Issues Working Group (AIWG), and Dr. Tamura, co-chair of the COPR Public Input and Participation Working Group (PIPWG), recapped the history of the two work groups and described work group plans for the following day. Mr. Sadwin explained that, at the October 2002 meeting, it was decided to form two project specific working groups. An Agenda Issues Work Group will address important COPR issues for each meeting and serve as primary liaison with the Director for meeting agenda development and related issues. This group will document the institutional memory for high-priority topics, track and document long-term initiatives to ensure follow-up between meetings, as well as develop meeting agendas. Dr. Tamura said the PIPWG will focus on enhancing public input and participation; specifically, by gathering information on broad-based mechanisms of public input. The work group will target specific categories of input that it has identified as having the greatest potential for eliciting meaningful input. The work group will focus on the thoughts and needs of the public audience, and how these affect the research priority-setting process, as well as how health research results are disseminated to the public and how the public understands and perceives the NIH. The group also will address intra-NIH issues such as how the I/Cs communicate with each other and how public members of NIH advisory bodies are trained. The work group has held several conference calls since the October meeting to clarify their direction. One call included some I/C Officers of Public Liaison (OPL) and Communication Directors (CD), after which the OPLs and CDs developed an outline of mechanisms for public input into the NIH. One work group task would be to review that document and determine next steps. Ms. Tetenbaum noted a discrepancy between the number of hits received on the NIH Web site and participation of the public on advisory groups and study sections. She suggested the work group consider the training needs of public members of these bodies. Dr. Tamura noted that COPR members previously raised the issue of holding another yearly meeting and were asked to justify the need. He suggested that interim work group meetings could be held between full COPR meetings. Dr. Zerhouni suggested that members who wished to hold an interim meeting develop a work plan to determine the need. Dr. Sigal pointed out that the IoM report on NIH restructuring would be released in June 2003 but the COPR is not scheduled to meet again until October 2003. She said the COPR should have a mechanism for responding to the report in June rather than in October. Action Item: Work group teleconferences will be held to determine the COPR's response to the IoM report. Dr. Zerhouni said the most common questions he hears about the NIH relate to its priority-setting process. Public input comes from many sources, including large organizations, patient advocacy groups, foundations, and universities. The process is influenced by many factors but is not transparent or deliberative. Clarifying this process for the public would be a significant task that would benefit the NIH and the public. COPR can help by crystallizing the process, finding a way to rationalize it, and carrying that message back to the general public. At this point, individual members expressed their reactions to the day's meeting.
Wrap-Up and Scheduling of Upcoming COPR MeetingsThe following future meeting dates were set: 2003:
2004:
The meeting was adjourned at 4:08 p.m. on Thursday, April 24, 2003.
This page was last reviewed on May 19, 2008. |
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