The 92nd meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held on June 2, 2006. NIH Director Elias A. Zerhouni, M.D., introduced three new ACD members — Alan Leshner, Ph.D., John C. Nelson, M.D., and Ralph Horowitz, M.D.
Dr. Zerhouni reviewed progress in the Congressional deliberations for the FY 2007 NIH budget, recalling his testimony before U.S. Senate and House committees. He explained trends in the NIH's funding during the past few years following the period of budget doubling — trends affected by strong increases in grant applications and increased research capacity at universities. In his testimony, Dr. Zerhouni illustrated a return on the public's investment in the NIH in terms of lives saved and productivity realized.
Dr. Zerhouni discussed common misperceptions about the NIH, noting that the amounts of applied and unsolicited research have remained fairly constant during the past decade. He presented an NIH strategy for the future, featuring the priorities of discovery, protection of young investigators, management of the supply and demand of grants, and a strengthening of NIH communications.
Mr. John T. Burklow presented ongoing NIH Office of Communications and Public Liaison efforts to pursuing a new integrated approach across the NIH. He reviewed the office's messages, audiences, and strategies, such as drawing a connection between scientific discovery and health. The ACD members encouraged these efforts and suggested enlisting the aid of practicing physicians.
Mr. Andrew C. Baldus, Acting Associate Director for Budget at the NIH, provided details of recent NIH budgets and the current $28 billion NIH budget, which represents about 1 percent of the total U.S. budget. In particular, the budget of the National Institute of Allergy and Infectious Diseases (NIAID) has grown rapidly in recent years, because of its involvement in important new research priorities — AIDS, other infectious diseases, and biodefense. For the period 1977 to 2007, the average investment per American — that is, contribution to the NIH budget — has been about $44 per year, or about $1,334 for the entire period. The projected success rate for FY 2007 NIH grant applications will be about 19 percent, which equals the rate for the previous year.
Michael M. Gottesman, M.D., Deputy Director for Intramural Research at NIH, reviewed the intramural research program, which accounts for about 9.5 percent of the NIH budget. The intramural programs offer stability for research careers and feature the training of about 1,000 summer students, 600 post-baccalaureates, 75 medical/dental students, 400 graduate students, and 3,800 postdoctoral fellows.
David A. Schwartz, M.D., Director of the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program, reviewed the challenges and opportunities of the NIEHS. The work supported by the NIEHS extends from basic biology to applied sciences, and NIEHS investigators have made progress in understanding how the environment affects public health, including mortality. The NIEHS is developing a project with the National Human Genome Institute — the Genes and Environment Initiative (GEI) — to cross-train individuals in environmental science and genomics, with the ultimate goal of determining how the environment contributes to genetic vulnerability and disease.
Wendy Chaite, J.D., member of the NIH Director's Council of Public Representatives (COPR) and liaison to the ACD, and Dr. Annelise Barron, ACD liaison to the COPR, reported on the COPR meeting that took place on April 21, 2006.
Mark Rohrbaugh, Ph.D., J.D., Director of the NIH's Office of Technology Transfer (OTT), described the work of his office, which has a goal of using intellectual property rights as incentive for commercial development of technologies. Dr. Rohrbaugh gave examples of technology-transfer success stories. More than 200 licensed products on the market were developed in part by NIH intramural scientists. These include drugs, vaccines, devices, and research tools such as reagents. Many more patents are pending.
ACD member Joan Y. Reede, M.D., presented her work group's latest list of additions to the full list of bona fide pre-screened awards (cash prizes) that NIH employees may receive. The ACD members examined and approved the new list of awards.
Other topics taken up by the ACD members included ways to reduce the administrative burden on scientific research and the possibility of private foundations providing bridge funding for meritorious research that fails to receive NIH funding.
NIH Director's Report
The 92nd meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held June 2, 2006, on the NIH campus in Bethesda, Maryland, and Webcast globally. The next meeting is tentatively scheduled for December 7–8, 2006. NIH Director Elias A. Zerhouni, M.D., welcomed the ACD members and other participants and guests. He noted that the NIH benefits each year from the advice of more than 30,000 advisors through committees such as the ACD, other advisory councils, peer-review panels, and boards.
Dr. Zerhouni introduced three new ACD members — Alan I. Leshner, Ph.D., Chief Executive Officer and Executive Publisher of Science, American Association for the Advancement of Science; John C. Nelson, M.D., Immediate Past President, American Medical Association; and Ralph I. Horowitz, M.D., Dean of the School of Medicine and Vice President for Medical Affairs, Case Western Reserve University. The new members were temporarily titled Special Experts of the Committee. ACD members J. Michael Bishop, M.D., Phillip L. Williams, and Arthur D. Ullian were unable to attend the meeting.
The NIH recruited and appointed Roger I. Glass, M.D, Ph.D., as the new director of the Fogarty International Center, the international arm of the NIH, which coordinates global activities. Dr. Glass is an expert on rotavirus vaccines, including their introduction in the developing world. Dr. Zerhouni will invite Dr. Glass to make a presentation at the next meeting of the ACD.
The ACD will play a role in selecting finalists for the NIH Director's Pioneer Award Program and in assessing science programs within the NIH Roadmap for Medical Research.
The FY 2007 appropriations request for the NIH is $28.4 billion, which equals the FY 2006 budget. NIH representatives took part in subcommittee budget hearings in the U.S. House of Representatives on April 6 and in the Senate on May 19. A Senate resolution calling for a $2 billion increase over the NIH request subsequently passed. The process in the House continues. The Congress continues to discuss the possibility of reauthorizing the NIH.
Financial strain for the NIH has resulted from the federal budget and trade deficits, homeland security needs, the fallout from hurricane Katrina, and the need to address potential pandemic flu. The completion of the NIH budget doubling a few years ago has produced what Dr. Zerhouni referred to as "budget fatigue." When combined with the increase in biomedical research costs, which is higher than general inflation, the NIH is seen to be in a unique financial bind, with strong competition for funds. Other factors contributing to this situation include increased capacity building that occurred as a result of the budget doubling (leading to large increases in grant applications) and a budget cycling phenomenon that produces periods of financial pressure (because of the fraction of grants that must be supported by uncommitted funds).
The NIH is currently managing a supply-demand situation in which grant applicants and applications have increased rapidly, resulting in a decreasing success rate. Dr. Zerhouni stated that about 80 percent of the drop in success rate results from increasing demand, and about 20 percent is the result of increases in the costs of grants and inflation. The budget cycling phenomenon should improve this slightly in 2007, as older grants end, freeing funds for new applicants.
Dr. Zerhouni discussed common misperceptions about the NIH. Some believe the NIH overemphasizes applied research. Yet a graph of NIH applied research shows it to be fairly constant during the past 8 years. Some say that the NIH has shifted toward solicited rather than unsolicited research. Yet the actual numbers reveal that unsolicited research, as a percentage of the whole, remained nearly constant between 1995 and 2005. Some say that the NIH Roadmap initiative shifts major funding away from the grant pool. Dr. Zerhouni stated that grant funding has not decreased; rather, a shifting toward priority projects has occurred. Misperceptions also exist about paylines and the percentage of grants funded. For example, because of re-applications, the success rates for applicants tend to be higher than the rates suggested by paylines.
Dr. Zerhouni described his strategy for the future, including attention to the following priorities:
Protect the core values and mission of the NIH — discovery and new knowledge.
Protect the future — young investigators.
Manage the key drivers — the supply and demand of grants.
Communicate proactively with a unified message.
Promote the NIH's vision for the future.
One message to disseminate is that medical research is a marathon, requiring time to mature. The NIH must maintain a balanced biomedical research portfolio with a strong emphasis on basic research and technology development. Unsolicited investigator-initiated research will create progress. The Pathway to Independence Award will provide opportunity for new investigators.
Dr. Zerhouni reviewed for the ACD members the presentation that he provided during the House and Senate hearings. The presentation contained analysis and strategies for the NIH in light of tight budgets, with a focus on communicating its business and accomplishments. It described the NIH's return on the American public's investment and the effects of the budget doubling. For example, over a 30-year period, a 63-percent decrease in mortality from coronary heart disease was associated with a $110 investment by each American ($3.70 per year). Advances in personalizing cancer treatments mean that 70,000 breast cancer patients each year might not have to undergo chemotherapy.
The NIH must communicate its vision down to the local level. It might portray itself as the National Institutes of Hope and present real instances of breakthroughs for patients and support for new medical technologies. The NIH can be part of the answer to the increasing costs of health care by developing new ways to practice medicine, especially in the area of prevention. Medicine of the future must be predictive, personalized, preemptive, and participatory.
Discussion
The ACD members suggested an additional focus on peer review, expressing a need to keep the quality of peer review high and to allow for high-risk research. Success should be defined as the subsequent research success of new investigators. The NIH should work to shorten the timeline to success, so that young researchers are not left unsupported for long periods. Dr. Zerhouni noted a current effort by the Center for Scientific Review (CSR) to shorten the application review cycle. The Pioneer Award program is testing an alternative peer-review process. Jeremy M. Berg, Ph.D., Director of the National Institute of General Medical Sciences (NIGMS), described the Pioneer Award program's application process, which emphasizes innovation.
Dr. Zerhouni recognized that the structure of the NIH budget results in a large amount of inertia. There are many stakeholders. The new Office of Portfolio Analysis and Strategic Initiatives (OPASI) is an effort to overcome this inertia by examining institute portfolios. Christine E. Seidman, M.D., suggested that the NIH study ways to reduce the costs of administering science, that is, to reduce indirect costs, for example, by using standard language and centralized mechanisms.
The ACD members recognized a need to better translate the NIH vision and accomplishments to the media and the public — a need that has been discussed by the Director's Council of Public Representatives (COPR). Perhaps private industries that benefit from the NIH could play a role in such an effort.
Communications Update
Mr. John Burklow, Associate Director of Communications and Public Liaison at the NIH, reviewed ongoing efforts of the NIH Office of Communications and Public Liaison, which has a goal of increasing public awareness of the benefits of the investment in biomedical research and the role that research will play in the new century. The NIH is responsive to questions raised by grantees, professional organizations, press, policymakers, and opinion-leaders. The Communications Office has been pursuing a new integrated approach across the NIH and across entities within the Office of the Director. Mr. Burklow stated that Dr. Zerhouni has been cited in press accounts five times more often than his predecessors.
Audiences for the NIH's messages include the NIH leadership and staffs, the scientific community, members of the public interested in health issues, the media, patient-advocacy organizations, health care provider and payer organizations, and the biomedical industry. Key messages include the NIH's roles in fighting disease and improving and saving lives. The Office stresses the idea that the NIH's investment in research takes place in every state of the union.
The current communication strategy focuses on facts and people, drawing a connection between scientific discovery and health and seeking to implement and institutionalize long-term communication activities. Tools include PowerPoint presentations, newsletters, and a new Web site that features research results, fact sheets, NIH funding information, NIH testimonies, and links to individual institute Web sites. Engagement with the press is proactive. The Communications Office will take part in regional research festivals involving universities and other stakeholders. The Friends of the National Library of Medicine (NLM) in collaboration with NLM and NIH have developed a new consumer-oriented quarterly magazine, NIH Medline Plus, which will be sent to physicians' offices across the nation.
Ongoing activities include Capitol Hill briefings, quarterly reports to Congress, and face-to-face visits by the NIH Directors. The NIH is developing a regular pipeline of information for dissemination, focusing on grants information, science, and research outcomes.
Discussion
The ACD members cited the potential of enlisting physicians — non-academic individuals and physician organizations — to disseminate the NIH's messages. They encouraged the Communications Office to ensure that the NIH name is cited in messages, to publicize the history of NIH achievements, to emphasize how research funding occurs, to educate investigators in ways to approach the NIH, and to motivate with emotion and values.
Appropriations and Budget Update
Mr. Andrew Baldus, Acting Associate Director for Budget at the NIH, stated that the NIH's budget of $28 billion represents about 1 percent of the FY 2007 U.S. budget. The NIH budget represents about 3 percent of the total U.S. discretionary budget. Mr. Baldus offered graphical evidence of recent trends, showing that the NIH doubling period also was a period when the U.S. ran budget surpluses. The NIH budget has been flat for the past three years.
The National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID) have the largest budgets within the NIH (at $4.75 billion and $4.39 billion, respectively). The NIAID budget in particular has grown rapidly in past years, because of its involvement in the important new research priorities for biodefense. Priorities in the new FY 2007 NIH budget include the following:
The Pathway to Independence Program.
The NIH Roadmap for Medical Research.
Biodefense-related activities.
Potential pandemic influenza.
The Genes, Environment and Health Initiative.
About 84 percent of NIH funds go to activities outside the NIH Bethesda campus — mainly to institutions within the United States. About 16 percent of NIH funds support the intramural research program and other research management and support activities of the NIH, most of which is located in the Bethesda area. Research project grants receive about 52 percent of NIH funds. Smaller fractions support research centers, training, contracts, intramural research, and resource management and support.
The proposed FY 2007 NIH budget calls for a total of 37,671 research project grants, a decrease of 656 from the previous year. This includes 9,337 competing research grants, which is an increase over FY 2006. The projected success rate for FY 2007 grant applications is about 19 percent, which equals the rate for the previous year.
For the period 1977 to 2007, the average investment per American — that is, contribution to the NIH budget — has been about $44 per year, or about $1,334 for the entire period. In recent years, because of inflation and a flat budget, the buying power of that investment has decreased slightly.
Discussion
The ACD members noted that although the NIH's buying power has increased modestly during the past 30 years, overall research support in the United States has risen substantially. Dr. Zerhouni suggested that this is because of large increases in philanthropy and borrowing by institutions.
Intramural Research
Michael M. Gottesman, M.D., Deputy Director for Intramural Research at the NIH, stated that the goal of the NIH intramural research program is to conduct innovative, high-risk, high-impact laboratory, clinical, and population-based research. Among the 27 institutes and centers (ICs) of the NIH, 22 have intramural research programs, accounting for about 9.5 percent of the NIH budget. The IC directors determine how much of their funding goes to intramural activities, and the percentages vary widely.
Additional priorities for intramural research include interdisciplinary research and training, addressing immediate public health needs, intramural-extramural collaborations, resource sharing, maintaining tenure-track investigators, and enhancing workforce diversity. The intramural programs offer stability for funding research careers. They make use of the NIH Clinical Center, which is dedicated to research; they employ a retrospective review process for investigators; and they enjoy extensive resources in bioinformatics, imaging, vaccine development, and animal models.
NIH intramural trainees include 1,000 summer students, 600 post-baccalaureates, 75 medical/dental students, 400 graduate students, and 3,800 postdoctoral fellows. The program features a substantial science review process involving outside Boards of Scientific Counselors, Blue Ribbon Panels, and outside accreditation bodies.
New initiatives in the intramural program include interdisciplinary research (e.g., physics, chemistry, and computer science in biology), bench-to-bedside programs (e.g., pairing laboratories and clinical investigators), and trans-NIH initiatives (currently being planned).
Discussion
Dr. Gottesman noted that the intramural program experiences a yearly turnover of about 5 percent, and recruits accordingly. About 50 percent of postdoc investigators are women — the percentage is less at other levels. NIH intramural researchers have developed many of the new vaccines in the United States. Interdependency exists between NIH intramural investigators, who create a vaccine, and private industry, which develops the vaccine for market. The ACD members agreed that this relationship should be better publicized.
Institute Director's Report
David A. Schwartz, M.D., Director of the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program, reviewed the challenges and opportunities for the NIEHS. The work supported by the NIEHS extends from basic biology to applied sciences. NIEHS investigators have made progress in understanding how the environment affects public health, including mortality. Such understanding has led to new standards to control particulate matter in the air and resulting increases in survival.
One example of an opportunity for progress is the study of DNA repair. Investigators are studying variations in the functioning of repair enzymes and will develop allele-specific approaches to advance repair in light of environmental influences. A key factor in future progress will be the development of precise measures of environmental exposure.
The NIEHS has developed programs — an Office of Translational Research and a clinical research unit on the NIEHS campus — that bring together basic and applied scientists to focus on complex diseases such as asthma. Because the NIEHS has a low percentage of physician-scientists compared to the other institutes, it has developed training programs to attract investigators. In the summer of 2006, the NIEHS will begin a program to evaluate school environments in New Orleans.
The NIEHS is developing the Genes and Environment Initiative (GEI) with the National Human Genome Institute to cross-train individuals in environmental science and genomics with the ultimate goal of determining how the environment contributes to genetic vulnerability and disease. More precise measures of exposure — biological and personalized —will be needed to make progress in analyzing gene-environment interactions. Within the GEI, an Exposure Biology Program will focus on environmental sensors, stress markers, and technologies. The GEI will seek to understand homeostatic mechanisms, pathogenesis, susceptibilities, phenotypes, and impact on public health.
Discussion
In discussion, Dr. Schwartz stated that health disparities are an essential component of the work of the NIEHS. Communicating genomic and environmental issues to communities is also important. Dr. Schwartz recognized a need to build research capacity within the NIEHS, and he described plans for training programs (K awards) and an R01 grant program for young investigators at universities.
NIH Director's Council of Public Representatives Liaison Report
Wendy Chaite, J.D., member of the NIH Director's Council of Public Representatives (COPR) and liaison to the ACD, and Annelise E. Barron, Ph.D., ACD liaison to the COPR, reported on the COPR meeting that took place on April 21, 2006. At that meeting, the COPR members forwarded the following recommendations to the Director:
Add a fourth "p" (for participatory) to the list of attributes of medical research.
Support OPASI and a strategic communication plan and include a COPR liaison for the knowledge-management initiative.
Identify additional opportunities for public involvement in research.
Educate investigators about the value and importance of public input.
Promote collaborative research.
Ms. Chaite and Dr. Barron stated that they would be meeting to discuss ways in which the ACD and COPR could establish stronger communications and linkages.
Dr. Zerhouni noted that the contributions of the COPR have strengthened in recent years. The group has, for example, aided the process for the Institutional Clinical and Translational Science Awards. In their discussion of better communication about the NIH, the ACD members proposed that investigators submit a second abstract for their work, addressed to the public, after the award is made. Tadaka Yamada, M.D., stated his belief that even basic scientists could benefit from involvement with the public and receiving its insights. Ms. Chaite invited Dr. Yamada to attend a COPR work group meeting to discuss that idea.
Translating Research to Results
Mark L. Rohrbaugh, Ph.D., J.D., Director of NIH's Office of Technology Transfer (OTT), defined technology transfer as the movement of information, materials, and technologies from research laboratories to commercial or other research enterprises. The development of patents and licenses is a small part of technology transfer. The primary goal is to use intellectual property rights as incentive for commercial development of technologies (rather than permitting them to become a hndrance). A secondary goal for OTT is to manage licensing and the collection of royalty fees to ensure a reasonable return on the public investment.
The institutes and centers of the NIH have coordinators who handle invention reporting and collaborative agreements. Royalties flow back to the ICs from which the licensed inventions derive. When a new invention (device, drug, etc.) is created, the OTT evaluates its patentability and its potential to be used by industry. The OTT manages the filing of patent applications, begins to market the invention before the patent is issued (which can take years), and negotiates licenses with companies for use. For FDA approved products, the company takes the product through clinical trials and the regulatory approval process, followed by product launch.
Dr. Rohrbaugh provided examples of technology-transfer success stories. Kepivance is keratinocyte growth factor that was discovered to be effective in treating oral mucositis, a common side effect of cancer therapies. TAXUS Express, a paclitaxel-coated cardiovascular stent, was developed from the discovery by NIH scientiststhat this coating on stents could reduce the development of scar tissue and subsequent restenosis.
More than 200 products that have reached the market were developed in part using technologies invented by NIH intramural scientists. These include drugs, vaccines, devices, and research tools such as reagents. Many more products are in development. The NIH has active cooperative research and development agreements (CRADAs) with about 350 companies. In FY 2005, about $98 million in royalties flowed back to the NIH. The OTT is working to transfer technologies internationally, especially to areas where the public health burden is great and local production might accelerate access to technologies. The Office hosts a Web site for technologies that can help address neglected diseases. The OTT Web site is at www.ott.nih.gov.
Discussion
The ACD members inquired about the use of royalty funds that flow back to the NIH, wondering if such money might be used to support more high-risk research. Dr. Gottesman noted that the relevant institutes have the option of determining how to use these funds, some of which go to high-risk research. Dr. Rohrbaugh stated that inventor scientists also receive a portion of the royalties, up to 25 percent of the funds received under a license to their inventions, with a cap of $150,000 per year per inventor.
The ACD members discussed the idea of capturing additional money from extramural research. However, administrative costs would be high and most inventions/licenses do not pan out economically. Dr. Zerhouni noted that when an invention discovered at the NIH finds success through a private company, a fraction of the profits returns to the government in the form of taxes.
Work Group Report on Outside Awards for NIH Employees
ACD member Joan Y. Reede, M.D., presented her work group's latest list of additions to the full list of bona fide pre-screened awards (cash prizes) that NIH employees/researchers may receive. The work group identified 20 additional awards for the prescreened list, and Dr. Reede asked the ACD members to approve their inclusion. The members approved the list unanimously.
An award can be added to the list of bona fide awards if it is part of an established program of recognition and results from independent selection criteria and nomination process. Raynard Kington, M.D., Ph.D., explained that new awards not on the list could be accepted by NIH employees only after an expedited, tentative review, after which the award would become part of the list of pre-screened awards. A special list has been created of very prestigious awards acceptable for upper-level staff.
Non-Agenda Topics
Dr. Seidman suggested that the NIH consider ways to reduce the administrative burdens on research. For example rules about the use of human subjects and animal models create large amounts of paperwork, lost time, and inefficiency. One possible remedy would be the use of a universal consent form for all Institutional Review Boards (IRBs). Dr. Zerhouni responded by asking Norka Ruiz Bravo, Ph.D., Deputy Director for Extramural Research, and Lana Skirboll, Ph.D., Director of Science Policy, to confer before the next ACD meeting and make a recommendation about how to approach this problem.
Dr. Barron proposed that the NIH seek ways to link private foundations with meritorious research that is unsuccessful in obtaining support from the NIH. Foundations might, for example, provide bridge funds to some researchers until they obtain new NIH funding.
Dr. Zerhouni noted that the NIH is considering the creation of a Blue Ribbon panel to evaluate the peer-review process. This will be placed on a future ACD meeting agenda.
Adjournment
Dr. Zerhouni thanked the ACD members and other participants and adjourned the meeting.
Summary and Conclusions
The Advisory Committee to the Director of the National Institutes of Health convened on June 2, 2006, to receive updates on the NIH Communications Plan and the FY 2007 NIH budget and appropriations process, to learn about activities of the NIH intramural research program, the NIH Office of Technology Transfer, and the National Institute of Environmental Health Sciences, to receive a report on the NIH Director's Council of Public Representatives, and to oversee the list of bona fide awards that NIH employees may receive, developed by the ACD's Work Group on Outside Awards for NIH Employees.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Raynard S. Kington, M.D., Ph.D. Executive Secretary, Advisory Committee to the Director, Deputy Director, NIH
Elias A. Zerhouni, M D. Chairman, Advisory Committee to the Director, Director, NIH
List of Abbreviations and Acronyms
ACD
Advisory Committee to the Director
COPR
Council of Public Representatives
CSR
Center for Scientific Review
FY
Fiscal Year
HHS
U.S. Department of Health and Human Services
ICs
Institutes and Centers
IRB
Institutional Review Board
NDPA
NIH Director's Pioneer Awards
NHGRI
National Human Genome Research Institute
NIAID
National Institute of Allergy and Infectious Diseases
NIEHS
National Institute of Environmental Health Sciences
NIGMS
National Institutes of General Medical Sciences
NIH
National Institutes of Health
NSF
National Science Foundation
OPASI
Office of Portfolio Analysis and Strategic Initiatives
