Risk of transmission of bovine spongiform encephalopathy to humans in the United States: Report of the Council on Scientific Affairs

JAMA

Volumn 281, Issue 24, 1999, Pages 2330-2339

  Tan, Litjen ^b   Williams, Michael A ^b   Khan, Mohamed Khaleem ^b   Champion, Hunter C ^b   Nielsen, Nancy H ^b   Dickinson, Barry ^a  

^a AMERICAN MEDICAL ASSOCIATION   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

PRION PROTEIN;

ARTICLE; BOVINE SPONGIFORM ENCEPHALOPATHY; CREUTZFELDT JAKOB DISEASE; DISEASE TRANSMISSION; EPIDEMIC; FOOD AND DRUG ADMINISTRATION; GENE; GOVERNMENT; HUMAN; LAW; MEAT; NONHUMAN; POLICY; PRIORITY JOURNAL; RISK; UNITED KINGDOM; UNITED STATES;

EID: 0033031255     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.281.24.2330     Document Type: Article

References (111)

1. Brown P. 1755 and all that: a historical primer of transmissible spongiform encephalopathy. BMJ. 1998; 317:1688-1692.
2. Prusiner SB. Biology and genetics of prion diseases. Annu Rev Microbiol. 1994;48:655-686.
3. Narang H. The nature of the scrapie agent: the virus theory. Proc Soc Exp Biol Med. 1996;212:208-224.
4. Gajdusek DC. Unconventional viruses causing subacute spongiform encephalopathies. In: Field BN, Melnick L, Chanock R, Shope RF, Roizman B, eds. Human Viral Infections. New York, NY: Raven Press; 1985:1519-1557.
5. Will RG, Ironside JW, Zeidler M, et al. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet. 1996;347:921-925.
6. Brown P. The risk of bovine spongiform encephalopathy ("mad cow disease") to human health. JAMA. 1997;278:1008-1011.
7. Griffith JS. Self-replication and scrapie. Nature. 1967; 215:1043-1044.
8. Bolton DC, Bendheim PE. A modified host protein model of scrapie. Ciba Foundation Symposium. 1988; 135:164-181.
9. Harris DA, Lele P, Snider WD. Localization of the mRNA for a chicken prion protein by in situ hybridization. Proc Natl Acad Sci USA. 1993;90:4309-4313.
10. Prusiner SB. Prion diseases and the BSE crisis. Science. 1997;278:245-251.
11. Ironside JW. Review: Creutzfeldt-Jakob disease. Brain Pathol. 1996;6:379-388.
12. Budka H, Aguzzi A, Brown P, et al. Neuropathological diagnostic criteria for Creutzfeldt-Jakob disease (CJD) and other human spongiform encephalopathies (prion diseases). Brain Pathol. 1995;5:459-466.
13. Prusiner SB, Bolton DC, Groth DF, et al. Further purification and characterization of scrapie prions. Biochemistry. 1982;21:6942-6950.
14. McKinley MP, Bolton DC, Prusiner SB. A protease-resistant protein is a structural component of the scrapie prion. Cell. 1983;35:57-62.
15. Gabizon R, McKinley MP, Groth DF, Kenaga L, Prusiner SB. Properties of scrapie prion protein liposomes. J Biol Chem. 1988;263:4950-4955.
16. Bueler H, Aguzzi A, Sailer A, et al. Mice devoid of PrP are resistant to scrapie. Cell. 1993;73:1339-1347.
17. Alper T, Cramp WA, Haig DA, Clarke MC. Does the agent of scrapie replicate without nucleic acid? Nature. 1967;214:764-766.
18. Riesner D, Kellings K, Meyer N, Mirenda C, Prusiner SB. Nucleic acids and scrapie prions. In: Prusiner SB, Collinge J, Powell J, Anderton B, eds. Prion Diseases of Animals and Humans. Chichester, England: Ellis Norwood; 1992:341-353.
19. Meyer N, Rosenbaum V, Schmidt B, et al. Search for a putative scrapie genome in purified prion fractions reveals a paucity of nucleic acids. J Gen Virol. 1991;72:37-49.
20. Robakis NK, Devine-Gage EA, Jenkins EC, et al. Localization of a human gene homologous to the PrP gene on the p arm of chromosome 20 and detection of PrP-related antigens in normal human brain. Biochem Biophys Res Commun. 1986;140:758-765.
21. Oesch B, Westaway D, Walchli M, et al. A cellular gene encodes scrapie PrP 27-30 protein. Cell. 1985;40:735-746.
22. Collinge J. Human prion diseases and bovine spongiform encephalopathy (BSE). Hum Mol Genet. 1997; 6:1699-1705.
23. Prusiner SB, Groth D, Serban A, et al. Ablation of the prion protein (PrP) gene in mice prevents scrapie and facilitates production of anti-PrP antibodies. Proc Natl Acad Sci USA. 1993;90:10608-10612.
24. Rogers M, Taraboulos A, Scott M, Groth D, Prusiner SB. Intracellular accumulation of the cellular prion protein after mutagenesis of its Asn-linked glycosylation sites. Glycobiology. 1990;1:101-109.
25. Prusiner SB. Novel proteinaceous infectious particles cause scrapie. Science. 1982;216:136-144.
26. Zhang S, Rich A. Direct conversion of an oligopeptide from a beta-sheet to an alpha-helix. Proc Natl Acad Sci USA. 1997;94:23-28.
27. Scott M, Foster D, Mirenda C, et al. Transgenic mice expressing hamster prion protein produce species-specific scrapie infectivity and amyloid plaques. Cell. 1989;59:847-857.
28. Prusiner SB, Scott M, Foster D, et al. Transgenetic studies implicate interactions between homologous PrP isoforms in scrapie prion replication. Cell. 1990;63:673-686.
29. Gabizon R, Taraboulos A. Of mice and (mad) cows: transgenic mice help to understand prions. Trends Genet. 1997;13:264-269.
30. Wells GA, Scott AC, Johnson CT, et al. A novel progressive spongiform encephalopathy in cattle. Vet Rec. 1987;121:419-420.
31. Wilesmith JW, Wells GA, Cranwell MP, Ryan JB. Bovine spongiform encephalopathy: epidemiological studies. Vet Rec. 1988;123:638-644.
32. Anderson RM, Donnelly CA, Ferguson NM, et al. Transmission dynamics and epidemiology of BSE in British cattle. Nature. 1996;382:779-788.
33. Lasmezas CI, Deslys JP, Demaimay R, et al. Strain specific and common pathogenic events in murine models of scrapie and bovine spongiform encephalopathy. J Gen Virol. 1996;77:1601-1609.
34. Brown P, Cathala F, Raubertas RF, Gajdusek DC, Castaigne P. The epidemiology of Creutzfeldt-Jakob disease. Neurology. 1987;37:895-904.
35. Will RG. Epidemiology of Creutzfeldt-Jakob disease. Br Med Bull. 1993;49:960-970.
36. Berg LJ. Insights into the role of the immune system in prion diseases. Proc Natl Acad Sci U S A. 1994; 91:429-432.
37. Hsiao K, Baker HF, Crow TJ, et al. Linkage of a prion protein missense variant to Gerstmann-Straussler syndrome. Nature. 1989;338:342-345.
38. Dlouhy SR, Hsiao K, Farlow MR, et al. Linkage of the Indiana kindred of Gerstmann-Straussler-Scheinker disease to the prion protein gene. Nat Genet. 1992;1:64-67.
39. Gabizon R, Rosenmann H, Meiner Z, et al. Mutation and polymorphism of the prion protein gene in Libyan Jews with Creutzfeldt-Jakob disease (CJD). Am J Hum Genet. 1993;53:828-835.
40. Duffy P, Wolf J, Collins G, et al. Possible person-to-person transmission of Creutzfeldt-Jakob disease [letter]. N Engl J Med. 1974;290:692-693.
41. Gibbs CJJ, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC. Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery. J Neurol Neurosurg Psychiatry. 1994;57:757-758.
42. Fradkin JE, Schonberger LB, Mills JL, et al. Creutzfeldt-Jakob disease in pituitary growth hormone recipients in the United States. JAMA. 1991; 265:880-884.
43. Creutzfeldt-Jakob disease associated with cadaveric dura mater grafts - Japan, January 1979-May 1996. MMWR Morb Mortal Wkly Rep. 1997;46:1066-1069.
44. MacKnight C, Rockwood K. Bovine spongiform encephalopathy and Creutzfeldt-Jakob disease: implications for physicians. CMAJ. 1996;155:529-536.
45. Prusiner SB. Genetic and infectious prion diseases. Arch Neurol. 1993;50:1129-1153.
46. Masters CL, Gajdusek DC, Gibbs CJJ. The familial occurrence of Creutzfeldt-Jakob disease and Alzheimer's disease. Brain. 1981;104:535-558.
47. Beck E, Daniel PM, Parry HB. Degeneration of the cerebellar and hypothalamo-neurohypophysial systems in sheep with scrapie: its relationship to human system degenerations. Brain. 1964;87:153-176.
48. Tateishi J, Nagara H, Hikita K, Sato Y. Amyloid plaques in the brains of mice with Creutzfeldt-Jakob disease. Ann Neurol. 1984;15:278-280.
49. Kitamoto T, Tateishi J, Tashima T, et al. Amyloid plaques in Creutzfeldt-Jakob disease stain with prion protein antibodies. Ann Neurol. 1986;20:204-208.
50. Chazot G, Broussolle E, Lapras C, Blattler T, Aguzzi A, Kopp N. New variant of Creutzfeldt-Jakob disease in a 26-year-old French man. Lancet. 1996;347:1181.
51. Zeidler M, Stewart GE, Barraclough CR, etal. New variant Creutzfeldt-Jakob disease: neurological features and diagnostic tests. Lancet. 1997;350:903-907.
52. Zeidler M, Johnstone EC, Bamber RW, et al. New variant Creutzfeldt-Jakob disease: psychiatric features. Lancet. 1997;350:908-910.
53. Hsich G, Kenney K, Gibbs CJ, Lee KH, Harrington MG. The 14-3-3 brain protein in cerebrospinal fluid as a marker for transmissible spongiform encephalopathies. N Engl J Med. 1996;335:924-930.
54. Hill AF, Butterworth RJ, Joiner S, et al. Investigation of variant Creutzfeldt-Jakob disease and other human prion diseases with tonsil biopsy samples. Lancet. 1999;353:183-189.
55. Piccardo P, Langeveld JP, Hill AF, et al. An antibody raised against a conserved sequence of the prion protein recognizes pathological isoforms in human and animal prion diseases, including Creutzfeldt-Jakob disease and bovine spongiform encephalopathy. Am J Pathol. 1998;152:1415-1420.
56. Korth C, Stierli B, Streit P, et al. Prion (PrPSc)-specific epitope defined by a monoclonal antibody. Nature. 1997;389:74-77.
57. Collee JG, Bradley R. BSE: a decade on - part 1. Lancet. 1997;349:636-641.
58. Gajdusek DC, Zigas V. Clinical, pathological and epidemiological study of an acute progressive degenerative disease of the central nervous system among natives of the eastern highlands of New Guinea. Am J Med. 1959;26:442-469.
59. Carp RI, Ye X, Kascsak RJ, Rubenstein R. The nature of the scrapie agent. Ann N Y Acad Sci. 1994; 724:221-234.
60. Narang HK. Origin and implications of bovine spongiform encephalopathy. Proc Soc Exp Biol Med. 1996;211:306-322.
61. Kimberlin RH, Walker CA, Fraser H. The genomic identity of different strains of mouse scrapie is expressed in hamsters and preserved on reisolation in mice. J Gen Virol. 1989;70:2017-2025.
62. Kimberlin RH, Wilesmith JW. Bovine spongiform encephalopathy: epidemiology, low dose exposure and risks. Ann N Y Acad Sci. 1994;724:210-220.
63. Office of International Epizootics. Bovine spongiform encephalopathy. Available at: http:// www.oie.int/Norms/MCode/A_00064.htm. Accessed December 1998.
64. World Health Organization. Report of a WHO consultation on medicinal and other products in relation to human and animal transmissible spongiform encephalopathies. WHO/EMC/ZOO/97.3. Available at: http://www.who.int/emc/diseases/bse/ tse_9703.html#a17. Accessed March 1999.
65. Bruce ME, Will RG, Ironside JW, et al. Transmissions to mice indicate that "new variant" CJD is caused by the BSE agent. Nature. 1997;389:498-501.
66. Hill AF, Desbruslais M, Joiner S, et al. The same prion strain causes vCJD and BSE. Nature. 1997;389: 448-450.
67. Almond J, Pattison J. Human BSE. Nature. 1997; 389:437-438.
68. Collinge J, Sidle KC, Meads J, et al. Molecular analysis of prion strain variation and the aetiology of "new variant" CJD. Nature. 1996;383:685-690.
69. National CJD Surveillance Unit. Monthly Creutzfeldt-Jakob figures. Available at: http:// www.cjd.ed.ac.uk/index.htm. Accessed January 1999.
70. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: public health. Available at: http://www.maff.gov.uk/animalh/bse/public-health/ public-health-index.html. Accessed December 1998.
71. Cousens SN, Vynnycky E, Zeidler M, et al. Predicting the CJD epidemic in humans. Nature. 1997; 385:197-198.
72. Office of International Epizootics. Informational report on bovine spongiform encephalopathy. Available at: http://www.oie.int/Status/A_bse.htm. Accessed December 1998.
73. Wilesmith JW, Ryan JB, Atkinson MJ. Bovine spongiform encephalopathy: epidemiological studies on the origin. Vet Rec. 1991;128:199-203.
74. Nathanson N, Wilesmith J, Grlot C. Bovine spongiform encephalopathy (BSE): causes and consequences of a common source epidemic. Am J Epidemiol. 1997;145:959-969.
75. Honstead JP. Prevention of bovine spongiform encephalopathy in the US through feed regulation. Paper presented at: National Managed Health Care Congress, 2nd International Conference on Transmissible Spongifonm Encephalopathies; November 17, 1997; Washington, DC.
76. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: incidence of BSE. Available at: http://www.maff.gov.uk/animalh/bse/bse-statistics/ level-3-incidence.html. Accessed December 1998.
77. Collee JG, Bradley R. BSE: a decade on - part 2. Lancet. 1997;349:715-721.
78. Prusiner SB. Genetic and infectious prion diseases. Arch Neurol. 1993;50:1129-1153.
79. Raymond GJ, Hope J, Kocisko DA, et al. Molecular assessment of the potential transmissibilities of BSE and scrapie to humans. Nature. 1997;388:285-288.
80. European Union Directorate General XXIV. Bovine Spongiform Encephalopathy (BSE): Information for Consumers. 3rd ed. Available at: http://europa .eu.int/comm/dg24/health/bse/bse09_en.pdf. Accessed October 1998.
81. European Union Directorate General XXIV. Commission decision 25-11-98 amending decision 98/ 256/EC as regards certain emergency measures to protect against bovine spongiform encephalopathy. Available at: http://www.maff.gov.uk/animalh/bse/ european-issues/ec-dec.pdf. Accessed December 1998.
82. European Union Directorate General XXIV. Final consolidated report to the temporary committee of the European Parliament on the follow-up of recommendations on BSE. Available at: http://europa.eu.int/comm/ dg24/health/bse/bse03_en.html. Accessed March 1999.
83. European Union Directorate General XXIV. Opinion on BSE risk adopted by the Scientific Steering Committee at its plenary meeting of 26-27 March 1998, following a public consultation on the preliminary opinion adopted on 19-20 February 1998. Available at: http://europa.eu.int/comm/dg24/health/sc/ssc/ out13_en.html. Accessed November 1998.
84. European Union Directorate General XXIV. Second bi-annual BSE follow-up report. Available at: http://europa.eu.int/comm/dg24/health/bse/ bse11_en.html. Accessed November 1998.
85. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: the feed ban. Available at: http://www.maff.gov.uk/animalh/bse/animal-health/ feed-ban.html. Accessed December 1998.
86. European Union Directorate General XXIV. Council decision of 17 December 1998 amending commission decision 97/534/EC on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies. Available at: http:// europa.eu.int/eur-lex/en/dat/1998/l_358 /l_35819981231en01130113.pdf. Accessed January 1999.
87. Drug-specific rules may replace mad cow ban. Washington Drug Letter. February 1, 1999:5.
88. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: specified risk materials - legislation. Available at: http://www.maff.gov.uk/ animalh/bse/public-health/level-4-srm-legislation-.html. Accessed December 1998.
89. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: bone in beef. Available at: http://www.maff.gov.uk/animalh/bse/public-health/ bone-in-beef.html. Accessed December 1998.
90. European Union Directorate General XXIV. No evidence for BSE transmission through milk. Available at: http://europa.eu.int/en/comm/spp/me/midday .html. Accessed March 1999.
91. Esmonde TF, Will RG, Slattery JM, et al. Creutzfeldt-Jakob disease and blood transfusion. Lancet. 1993;341:205-207.
92. Ricketts MN, Cashman NR, Stratton EE, El Saadany S. Is Creutzfeldt-Jakob disease transmitted in blood? Emerg Infect Dis. 1997;3:155-163.
93. Ministry of Agriculture Fisheries and Food UK. MAFF BSE information: SEAC meeting. 24 October 1997. Available at: http://www.maff.gov.uk/animalh/ bse/bse-publications/seac-24-oct-97.html. Accessed December 1998.
94. Brown P, Rohwer RG, Dunstan BC, MacAuley C, Gajdusek DC, Drohan WN. The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy. Transfusion. 1998;38:810-816.
95. Murray I. Blood donations to be treated against CJD. The Sunday London Times. Available at: www .sunday-times.co.uk:80/cgi-bin/Backissue?2135201. Accessed January 1999.
96. von Radowitz J, Ellis R. Plasma Recall. PA News. Available at: http://neon.airtime.co.uk/bse/news10 .htm. Accessed December 1998.
97. Cutlip RC, Miller JM, Race RE, et al. Intracerebral transmission of scrapie to cattle. J Infect Dis. 1994; 169:814-820.
98. United States Department of Agriculture Animal and Plant Health Inspection Service. Bovine spongiform encephalopathy. Available at: http://www .aphis.usda.gov/oa/pubs/fsbse.html. Accessed December 1998.
99. Guiroy DC, Williams ES, Liberski PP, Wakayama I, Gajdusek DC. Ultrastructural neuropathology of chronic wasting disease in captive mule deer. Acta Neuropathol (Berl). 1993;85:437-444.
100. Marsh RF, Bessen RA, Lehmann S, Hartsough GR. Epidemiological and experimental studies on a new incident of transmissible mink encephalopathy. J Gen Virol. 1991;72:589-594.
101. Hueston WD. The State of TSE in the US: managing the risks. Paper presented at: National Managed Health Care Congress, 2nd International Conference on Transmissible Spongiform Encephalopathies; November 17, 1997; Washington, DC.
102. United States Department of Agriculture Animal and Plant Health Inspection Service. Importation of animal products and by-products from countries where BSE exists (final rule). 56 Federal Register 63868-63869 (1991).
103. Porter R, Drazek P. USDA restricts imports of animals and animal products from Europe. USDA APHIS Legislative and Public Affairs, APHIS Press Releases. Available at: http://www.aphis.usda.gov/lpa/press/ 1997/12/eubse.txt. Accessed March 1999.
104. Food and Drug Administration. Substances prohibited from use in animal food or feed; animal proteins prohibited in ruminant feed (final rule). 62 Federal Register 30936-30978 (1997).
105. United States Department of Agriculture. USDA continues efforts to prevent BSE. Available at: http:// www.aphis.usda.gov/oa/bse/bsepress.html. Accessed March 1999.
106. Holman RC, Khan AS, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States, 1979-1994. Emerg Infect Dis. 1996;2:333-337.
107. Food and Drug Administration. Bovine spongiform encephalopathy (BSE) in products for human use: guidance for industry on the sourcing and processing of gelatin to reduce potential risk (notice). 62 Federal Register 52345-52346 (1997).
108. Hellman KB. FDA Regulation: Device-related issues in implantables and tissue-engineered combination products. Paper presented at: National Managed Health Care Congress, 2nd International Conference on Transmissible Spongiform Encephalopathies; November 18, 1997; Washington, DC.
109. Dodelet V, Ricketts M, Cashman NR. Emerging problems in prion disease. CMAJ. 1996;155:549-551.
110. Food and Drug Administration. Revised precautionary measures to reduce the possible transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products: guidance document (notice). 62 Federal Register 49694-49695 (1997).
111. Food and Drug Administration. Change to the guidance entitled "Revised precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products" (notice). Available at: http://www.fda.gov/cber/ infosheets/cjdchange.htm Accessed March 1999.