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Commentaries

Evidence-Based Toxicology: “Sound Science” in New Disguise

Pages 299-306 | Published online: 19 Jul 2013

Notes and References

  • Hoffmann S, Hartung T. Toward an evidence-based toxicology. Hum Exp Toxicol. 2006; 25: 497–513.
  • EBT: Evidence-based Toxicology. Italy. [cited 20081 Available from: www.ebtox.org.
  • Guzelian PS, Victoroff MS, HaImes NC., et al Evidence-based toxicology: a comprehensive framework for causation. Hum Exp Toxicol. 2005; 24: 161–201.
  • U.S. Environmental Protection Agency. Guidelines for Carcino-gen Risk Assessment. Risk Assessment Forum Washington, DC EPA/630/P-03/001F, March 2005. [cited 20081 (Available from: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfin?deid=116283).
  • International Agency for Research on Cancer (IARC) Preamble to their Monographs. . [cited 20081 Available from www.iarc.fr
  • National Toxicology Programme& apos;s 11th Report on Carcino-gens. [cited 20081 Available from;ntp.niehs.nih.gov
  • Carbone M, Klein G, Gruber J, Wong M. Modern Criteria to Establish Human Cancer Etiology. Cancer Res. 2004; 64: 5518–5524.
  • Hill AB. The Environment and Disease: Association or Causa-tion? Proc R Soc Med. 1965; 58: 295–300 (p. 299).
  • Taubes G. Epidemiology faces its limits. Science. 1995; 269: 164–9.
  • Wynder EL. Invited Commentary. Response to Science Article, ‘Epidemiology Faces Its Limits’. Am J Epidemiol. 1996; 143: 747–749.
  • Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years-observations on male British doctors. BMJ. 2004; 328: 1519. (Table 1, p.3)
  • NRC, National Research Council. Risk assessment in the federal government-Managing the process, National Academy Press; 1983.
  • NRC, National Research Council. Science and judgement in risk assessment. Committee on risk assessment of hazardous air pollutants, Commission on life sciences, NRC Washington DC, National Academy Press; 1994.
  • European Commission. Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances Commission Regu-lation (EC) No 1488/94 on Risk Assessment for existing sub-stances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market 2003. [cited 20081 Available from:ecbjrc.it
  • U.S. Environmental Protection Agency. Guidelines for Carcino-gen Risk Assessment. Risk Assessment Forum Washington, DC EPA/630/P-03/001F, March 2005. [cited 2008] (Available from: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=11628 3).
  • Shelby MD. National Toxicology Program Center for the Evalu-ation of Risks to Human Reproduction: Guidelines for CERHR Expert Panel Members Birth Defects Research (Part B) 2005; 74: 9-16. [cited 2008] Available from: http://cerhtniehs. nih.goy/reports/journal/CERHRguidelines.pdf
  • Meek ME, Bucher JR, Cohen SM., et al A Framework for Human Relevance Analysis of Information on Carcinogenic Modes of Action. Grit Rev Toxicol. 2003; 33: 591–653.
  • Boobis AR, Cohen SM, Dellarco V., et al IPCS Framework for Analyzing the Relevance of a Cancer Mode of Action for Humans. Crit Rev Toxicol. 2006; 36: 781–792.
  • Commission Directive 2001/59/EC of 6 August 2001adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packag-ing and labelling of dangerous substances Official Journal of the European Communities L 225/1 21.8.2001.
  • Commission Directive 2003/63/EC on Community code relat-ing to medicinal products for human use (EC, 2003a) amends Directive 2001/83, Annex I.
  • Tomatis L, Melnick RL, Haseman J., et al Alleged ‘misconcep-tions’ distort perceptions of Environmental cancer risks. EASES J. 2001; 15: 195–203.
  • Herrington DM, Howard TD. From Presumed Benefit to Poten-tial Harm-Hormone Therapy and Heart Disease. N Engl J Med. 2003; 349: 519–521.
  • Bucher JR. The National Toxicology Program Rodent Bioassay. Ann N Y Acad Sci. 2002; 982: 198–207.
  • Olson H, Graham B, Robinson D., et al Concordance of the Toxicity of Pharmaceuticals in Humans and in Animals. Regul Toxicol Pharmacol. 2000; 32: 56–67.
  • See, for example, Mooney C. The Fraud of 'Sound Science.” Gadflyer. 2004 May 13. Available from: www.alternet.org/Story/ 18696.
  • It is interesting to note that Guzelian et al pay a tribute to judge Osteen's criticism of EPA's 1993 report “Respiratory Health Effects of Passive Smoking” in which EPA concluded that envi-ronmental tobacco smoke is a carcinogen (p. 171). They do not however mention that judge Osteen is a former tobacco lobby-ist or that massive evidence obtained in the years after EPA's 1993 report showed that EPA was right. Neither do they share the information that Osteen's judgment was appealed to the United States Court of Appeals and dismissed on technical grounds(http://www.ocat.org/opposition/industry_campaigns.html). Both IARC and NTP have declared environmen-tal tobacco smoke as being carcinogenic to humans (See www.iarc.fr, National Toxicology Programme's 1 1 th Report on Carcinogens [ntp.niehs.nih.gov].) Judge Osteen's criticism is available at: http: / /www.tobacco.org/Documents/ 98071 '7 osteen.html.
  • Ong EK, Glantz AS. Constructing “sound science” and “good epidemiology": Tobacco, lawyers, and public relations firms. Am J Public Health. 2001; 91: 1749–1757.
  • Documents relating to Guzelian's involvement with the tobacco industry [cited 20081. Available from: http://tobaccodocu ments.org/profiles/guzelian_philip.html, http://legacy.library. ucsf.edu and http://tobaccodocuments.org.
  • Deposition of Philip S. Guzelian in the case of Jesus Delaluz v. Safety-Kleen Corporation, et al., Superior Court of the State of California for the County of Los Angeles, May 13, 2000.
  • Trial Testimony of Philip S. Guzelian in the case of Jesus Delaluz v. Safety-Kleen Corporation, et al., Superior Court of the State of California for the County of Los Angeles, June 8, 2000.
  • Atlantic Legal Foundation. Atlantic Legal News Archive. [cited 2008] Available from: http://www.atlanticlegal.org/newsitern. php?nid=40.
  • Atlantic Legal Foundation. Sound Science. [cited 20081 Avail-able from: http://www.atlanticlegal.org/program.php?catid=2.
  • Deposition Of Philip S. Guzelian, Jr., M.D. Cause No. 96-Cvq01439-D3; Manuela Navarro, vs. Missouri Pacific Railroad Company D/B/A Union Pacific Railroad Company, et al. 341st Judicial District Court, Webb County, Texas May 28, 1999.

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