Animal carcinogenicity studies: 1. Poor human predictivity

Alternatives to Laboratory Animals

Volumn 34, Issue 1, 2006, Pages 19-27

  Knight, Andrew ^a   Bailey, Jarrod ^b   Balcombe, Jonathan ^c  

^a Animal Consultants International   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE   (United States)

Author keywords

Animal experiment; Animal test; Bioassay; Cancer prevention; Carcinogenicity; Chemical classification; Chemical safety; Risk assessment

Indexed keywords

CARCINOGEN;

ANIMAL EXPERIMENT; ARTICLE; BIOASSAY; CARCINOGENICITY; CHEMICAL CARCINOGENESIS; DATA BASE; ENVIRONMENTAL PROTECTION; INFORMATION SYSTEM; NONHUMAN; PREDICTION; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING; TUMOR; UNITED STATES; VALIDATION PROCESS;

ANIMALIA;

EID: 85088734288     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290603400117     Document Type: Article

References (41)

1. Huff, J. (1999). Long-term chemical carcinogenesis bioassays predict human cancer hazards. Issues, controversies, and uncertainties. Annals of the New York Academy of Sciences 895, 56-79.
2. Wilbourn, J., Haroun, L., Heseltine, E., Kaldor, J., Partensky, C. & Vainio, H. (1986). Response of experimental animals to human carcinogens: an analysis based upon the IARC Monographs Programme. Carcinogenesis 7, 1853-1863.
3. Tomatis, L., Aitio, A., Wilbourn, J. & Shuker, L. (1989). Human carcinogens so far identified. Japanese Journal of Cancer Research 80, 795-807.
4. Rail, D.P. (2000). Laboratory animal tests and human cancer. Drug Metabolism Reviews 2, 119-128.
5. Ennever, F.K., Noonan, T.J. & Rosenkranz, H.S. (1987). The predictivity of animal bioassays and short-term genotoxicity tests for carcinogenicity and non-carcinogenicity to humans. Mutagenesis 2, 73-78.
6. Meijers, J.M., Swaen, G.M. & Bloemen, L.J. (1997). The predictive value of animal data in human cancer risk 4ssessment. Regulatory Toxicology and Pharmacology 25, 94-102.
7. Gold, L.S., Slone, T.H. & Ames, B.N. (1998). What do animal cancer tests tell us about human cancer risk? Overview of analyses of the carcinogenic potency database. Drug Metabolism Reviews 30, 359-404.
8. Monro, A. (1996). Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents? Experimental and Toxicologic Pathology 48, 155-166.
9. Monro, A.M. & MacDonald, J.S. (1998). Evaluation of the carcinogenic potential of pharmaceuticals. Opportunities arising from the International Conference on Harmonisation. Drug Safety 18, 309-319.
10. Ashby, J. (1996). Alternatives to the two-species bioassay for the identification of potential human carcinogens. Human and Experimental Toxicology 15, 183-202.
11. Gold, L.S., Manley, N.B., Slone, T.H., Rohrbach, L. & Garfinkel, G.B. (2005). Supplement to the Carcinogenic Potency Database (CPDB): results of animal bioassays published in the general literature through 1997 and by the National Toxicology Program in 1997-1998. Toxicological Sciences 85, 747-808.
12. Greek, C.R. & Greek, J.S. (2000). Sacred Cows and Golden Geese: The Human Costs of Experiments on Animals. 242pp. New York, NY, USA: Continuum International.
13. Stephens, M.L., Mendoza, P., Hamilton, T. & Weaver, A. (1998). Unrelieved pain and distress in animals: an analysis of USDA data on experimental procedures. Journal of Applied Animal Welfare Sciences 1, 15-26.
14. Canadian Council on Animal Care (1998). CCAC Animal Use Survey. 14pp. Ottawa, Canada: CCAC.
15. Peto, R., Pike, M.C., Bernstein, L., Gold, L.S. & Ames, B.N. (1984). The TD50: A proposed general convention for the numerical description of the carcinogenic potency of chemicals in chronic-exposure animal experiments. Environmental Health Perspectives 58, 1-8.
16. Pound, P., Ebrahim, S., Sandercock, P., Bracken, M.B. & Roberts, I. (2004). Where is the evidence that animal research benefits humans? Much animal research into potential treatments for humans is wasted because it is poorly conducted and not evaluated through systematic reviews. British Medical Journal 328, 514-517.
17. Anon. (2004). US Environmental Protection Agency. Website http://www.epa.gov (Accessed 29.1.04).
18. Anon. (2003). U.S. EPA's Process for IRIS Assessment Development and Review. Website http://www. epa.gov/iris/process.htm (Accessed 10.12.03).
19. Anon. (2004). What is IRIS? Website http://www. epa.gov/iris/intro.htm (Accessed 29.1.04).
20. Anon. (1999). Objective and Scope. IARC 7 Dec. 1999. Website http://www-cie.iarc.fr/monoeval/objectives.html (Accessed 12.1.05).
21. Anon. (2004). IRIS Database for Risk Assessment. Website http://www.epa.gov/iris/index.html (Accessed 1.1.04).
22. Anon. (2002). National Toxicology Program Report on Carcinogens, 10th Edn. Website http://ntp.niehs.nih. gov/ntpweb/index.cfm?objectid=72016262-BDB7- CEBA-FA60E922B18C2540 (Accessed 13.1.05).
23. Agresti, A. & Coull, B.A. (1998). Approximate is better than "exact" for interval estimation of binomial proportions. The American Statistician 52, 119-126.
24. Tomatis, L. & Wilbourn, J. (1993). Evaluation of carcinogenic risk to humans: the experience of IARC. In New Frontiers in Cancer Causation (ed. O. Iversen), pp. 371-387. Washington DC, USA: Taylor and Francis.
25. Anon. (2005). Guidelines for Carcinogen Risk Assessment. EPA/630/P-03/001B. Washington DC, USA: Risk Assessment Forum, U.S. Environmental Protection Agency. Website http://www.epa.gov/iris/backgr-d.htm (Accessed 11.12.05).
26. Anon. (2005). Internal Report 05/001: Report of the Advisory Group to Recommend Updates to the Preamble to the IARC Monographs. Lyon, France: IARC.
27. Anon. (1999). Data for the Monographs. Website http://www-cie.iarc.fr/ monoeval/data.html (Accessed 12.12.05).
28. Anon. (2005). Studies of Cancer in Experimental Animals. Website http://www-cie.iarc.fr/monoeval/studiesanimals.html (Accessed 12.12.05).
29. Anon. (2000). Characterisation of Data Uncertainty and Variability in IRIS Assessments: Pre-pilot vs. Pilot/Post-pilot. 46pp. Springfield, VA, USA: Versar, Inc.
30. Haseman, K. (2000). Using the NTP database to assess the value of rodent carcinogenicity studies for determining human cancer risk. Drug Metabolism Reviews 32, 169-186.
31. Ashby, J. & Purchase, I.F.H. (1993). Will all chemicals be carcinogenic to rodents when adequately evaluated? Carcinogenesis 8, 489-495.
32. Shirai, T., Fukushima, S., Ohshima, M. & Ito, N. (1984). Effects of butylated hydroxyanisole, butylated hydroxytoluene, and NaCl on gastric carcinogenesis initiated with N-methyl-N-nitro-N-nitrosoguanidine in F344 rats. Journal of the National Cancer Institute 72, 1189-1198.
33. Fung, V., Barrett, J. & Huff, J. (1995). The carcinogenesis bioassay in perspective: application in identifying human hazards. Environmental Health Perspectives 103, 680-683.
34. Gold, L.S., Bernstein, L., Magaw, R. & Slone, T.H. (1989). Interspecies extrapolation in carcinogenesis: prediction between rats and mice. Environmental Health Perspectives 81, 211-219.
35. Ennever, F.K. & Lave, L.B. (2003). Implications of the lack of accuracy of the lifetime rodent bioassay for predicting human carcinogenicity. Regulatory Toxicology and Pharmacology 38, 52-57.
36. Johnson, F.M. (2001). Response to Tennant et al.: attempts to replace the NTP rodent bioassay with transgenic alternatives are unlikely to succeed. Environmental Molecular Mutagenesis 37, 89-92.
37. Viscusi, W.K. & Hakes, J.K. (1998). Synthetic risks, risk potency, and carcinogen regulation. Journal of Policy Analysis and Management 17, 52-73.
38. International Agency for Research on Cancer (1972-1992). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volumes 1-55. Lyon, France: IARC.
39. International Agency for Research on Cancer, (undated). IARC monographs programme on the evaluation of carcinogenic risks to humans. Website http://monographs.iarc.fr (Accessed 1.1.04).
40. Epstein, S.S. (1998). The Politics of Cancer, Revisited. 770pp. Fremont Center, NY, USA: East Ridge Press.
41. Gold, L.S., Manley, N.B., Slone, T.H. & Rohrbach, L. (1999). Supplement to the Carcinogenic Potency Database (CPDB): results of animal bioassays published in the general literature in 1993 to 1994 and by the National Toxicology Program in 1995 to 1996. Environmental Health Perspectives 107, Suppl. 4, 527-600.