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__ Introduction In June 2002, the Institute of Medicine (IOM) formed the Committee on Transmissible Spongiform Encephalopathies: Assessment of Rel- evant Science to assist the U.S. Department of Defense (DOD) in its administration of the National Prion Research Project (NPRP). Congress had established NPRP and had directed the U.S. Army Medical Research and Materiel Command (MRMC) to administer the program, allocating $50 million to fund it (U.S. Senate Committee on Appropriations, 2001~. Congress ultimately reduced the allocation to $42.5 million. MRMC man- ages NPRP through the preexisting Congressionally Directed Medical Re- search Program. NPRP issued its first call for proposals in August 2002 (DOD, 2002~. To evaluate the proposals submitted, the program uses the two-tiered ap- proach recommended by the Institute of Medicine (IOM, 1993~. Proposals first undergo peer review for scientific merit. Those passing review undergo another level of review that involves evaluating how well the proposed re- search would support NPRP's objectives. Subject-matter experts, clinicians, and consumers chosen by DOD conduct the programmatic review (DOD, 2002~. To support this proposal evaluation process, DOD asked the IOM to provide independent advice on the state of prion science and the field's most pressing research needs (see Box 1-1~. In June 2002, the IOM formed an 11-member committee supplemented by six consultants who are inter- nationally recognized experts in prion research; a member of the Board of the Medical Follow-up Agency was added to the committee as a liaison in early 2003. The committee members were selected for their expertise in 33

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34 ADVANCING PRION SCIENCE infectious disease, prion molecular biology, microbiology, neurology, epi- demiology, blood banking, veterinary medicine, and food safety. The con- sultants provided essential technical insight. The committee evaluated in- formation from the sponsor, peer-reviewed journal articles provided by committee staff, and presentations by invited guests with expertise relevant to prion science (see Appendix A).

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INTROD UCTION 35 CHARGE TO THE COMMITTEE The committee was tasked to produce both an interim and a final re- port. The interim report, published in January 2003, provided guidance to the pane! that conducted the programmatic review for NPRP's fiscal year 2002 grants. The report concentrated on diagnostics for transmissible spongiform encephalopathies (TSEs), the focus of both the law establishing NPRP and the program announcement. The law states: "The priority goal of the Project's first phase is to rapidly develop a diagnostic test to detect the presence of prion disease." The investment strategy and guidance pub- lished in the NPRP program announcement reflect this imperative (DOD, 20021. Nearly 50 percent of the funds allocated in fiscal year 2002 $20 million was to support investigator-initiated research designed to do the following: protons prlons Develop a rapid, sensitive, and reproducible test for the detection of suitable for use as an antemortem diagnostic test. Develop a rapid, sensitive, and reproducible test for the detection of suitable for use as a screening assay. ~ . . . . . . . , Stun y t" be prevention, transmission, inactivation, or pat" ~ogenes1s ot TSEs, including chronic wasting disease (CWD) (see Table 1-11. This, the committee's final report, recommends the highest-priority re- search in TSE surveillance, prevention, and therapy. It also contains an updated version of the material from the first report, with an additional chapter on the unique challenges of detecting TSE infectivity in blood. This report could help shape the objectives of NPRP should the pro- gram receive future funding. The report is also intended to perform a public service by providing the most comprehensive overview known to the com- mittee and consultants of the many ways in which TSEs impact human and animal health. Educated laypeople, physicians, scientists, and TSE experts should find relevant information herein about a class of diseases that ap- pear to be caused by a new and mysterious biological mechanism. ORGANIZATION OF THE REPORT Chapter 2 provides background information about prion diseases, while Chapter 3 reviews the basic research requirements to advance prion science. Chapters 4, 5, and 6 address, respectively, diagnostics for TSEs, testing of blood for evidence of TSE agents, and measures taken by the United States to conduct surveillance for the occurrence of TSEs in people and animals. Chapter 7 provides an assessment of strategies to prevent and treat TSEs.

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38 ADVANCING PRION SCIENCE The U.S. infrastructure for TSE research is reviewed in Chapter 8, while Chapter 9 presents an assessment of the risks of TSEs to the U.S. military. Throughout the text, the committee presents its recommendations in bold print, numbered by chapter for ease of reference. (Table S-1, presented in the Summary, lists all of the committee's recommendations.) Clearly, we believe all the recommendations in this report are important. Given that NPRP has a limited amount of resources, however, it can act on only a limited number of recommendations each fiscal year. Therefore, we have prioritized the recommendations by placing them in one of three ranks, 1 being the highest. We assigned approximately a third of the recommenda- tions to each rank. The rankings are based upon the following criteria: Impact on public health Impact on protecting animal health (mainly cattle) Impact on protecting the U.S. economy (bovine spongiform encepha- lopathy LBSE]/CWD) Impact on advancing scientific understanding of prions (potential for breakthroughs) The need to accomplish first rather than second (stepwise progres- sion of the science) Return on investment Likelihood of success (How feasible is it?) In addition to prioritizing all of our recommendations, we indicate the most urgent and critical areas of research related to recommendations 3.1 and 6.4 (see Boxes 3-1 through 3-4 and Box 6-3 in the respective chapters). The report ends with two appendices: Appendix A contains the agen- das for the five meetings held by the committee during the course of the study, while Appendix B presents biographical sketches of the committee members and consultants. REFERENCES DOD (U.S. Department of Defense). 2002. Department of Defense Fiscal Year 2002 National Prion Research Program Program Announcement, Part 1. Fort Detrick, MD: Head- quarters, U.S. Army Medical Research and Materiel Command. IOM (Institute of Medicine). 1993. Strategies for Managing the Breast Cancer Research Pro- gram: A Report to the U.S. Army Medical Research and Development Command. IOM Committee to Advise the Department of Defense on Its Fiscal Year 1993 Breast Cancer Program. Washington, DC: National Academy Press. U.S. Senate Committee on Appropriations. 2001. Senate Report 107-109. Department of De- fense Appropriation Bill, 2002 and Supplemental Appropriations, 2002. Title VI. Public Law 107-117, H.R. 3338. Washington, DC: U.S. Congress.