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Cited by 7 publications
References 51 publications
identification, dose-response assessment, human exposure Risk Characterization: A Bridge to Informed Decision Making. assessment) that is relevant to human risk. Each question Ohanian, E. V., and Moore, J. A. (1997). Fundam. Appl. Toxicol. calls for analysis and interpretation of available studies, se-39, 81-88.lection of the concepts and data that are most scientifically Regulatory decisions should be made in the most expert and reliable and most relevant to the problem at hand, and scieninformed way since they are precipitated by real and perceived tific conclusions regarding the question presented. Risk charthreats to human health, under the glare of public scrutiny. In acterization is the summarizing step of risk assessment. The 1994, the National Research Council (NRC) reported that the U.S. risk characterization integrates information from the preced-Environmental Protection Agency's (USEPA's) overall approach ing components of the risk assessment and synthesizes an to assessing risks is fundamentally sound, but the Agency must overall conclusion about risk that is complete, informative, more clearly establish the scientific and policy basis for risk estiand useful for decision makers or risk managers. According mates and better communicate the associated uncertainties. On to the March 1995 Risk Characterization Policy and Guid-March 21, 1995, USEPA issued a risk characterization policy andance (Ohanian, 1995; USEPA, 1995 USEPA, , 1996, each risk characguidance. In this policy, an effective risk characterization must terization should be prepared in a manner that is clear, transfully and clearly characterize risks and disclose the scientific analysis, uncertainties, assumptions, and science policy that underlie parent, reasonable, and consistent with other risk characterdecisions throughout the risk assessment process. A number of izations of similar scope prepared by the USEPA. Risk regulatory reform bills which required risk characterization as part assessors are charged with (1) generating a credible, objecof all Federal risk assessments were introduced by the 104th Contive, realistic, and scientifically balanced analysis; and (2) gress. The purpose of this workshop was to familiarize Society of explaining confidence in each assessment by clearly deline-Toxicology members with: (1) key elements to be considered in ating strengths, limitations, uncertainties, default assumprisk characterization and (2) new advances in risk characterization tions, along with the impacts of these factors on the overall addressed by Federal and State agencies, industry, academia, assessment. Since every assessment carries uncertainties, a NRC, and Presidential/Congressional Commission on Risk Assesssimplified numerical presentation of health risk is always ment and Risk Management. Furthermore, the main objective was incomplete and often misleading. Characterizing risk to to engage the audience in discussing the proper role of science include qualitative information should be encouraged to in risk assessment-risk management...
identification, dose-response assessment, human exposure Risk Characterization: A Bridge to Informed Decision Making. assessment) that is relevant to human risk. Each question Ohanian, E. V., and Moore, J. A. (1997). Fundam. Appl. Toxicol. calls for analysis and interpretation of available studies, se-39, 81-88.lection of the concepts and data that are most scientifically Regulatory decisions should be made in the most expert and reliable and most relevant to the problem at hand, and scieninformed way since they are precipitated by real and perceived tific conclusions regarding the question presented. Risk charthreats to human health, under the glare of public scrutiny. In acterization is the summarizing step of risk assessment. The 1994, the National Research Council (NRC) reported that the U.S. risk characterization integrates information from the preced-Environmental Protection Agency's (USEPA's) overall approach ing components of the risk assessment and synthesizes an to assessing risks is fundamentally sound, but the Agency must overall conclusion about risk that is complete, informative, more clearly establish the scientific and policy basis for risk estiand useful for decision makers or risk managers. According mates and better communicate the associated uncertainties. On to the March 1995 Risk Characterization Policy and Guid-March 21, 1995, USEPA issued a risk characterization policy andance (Ohanian, 1995; USEPA, 1995 USEPA, , 1996, each risk characguidance. In this policy, an effective risk characterization must terization should be prepared in a manner that is clear, transfully and clearly characterize risks and disclose the scientific analysis, uncertainties, assumptions, and science policy that underlie parent, reasonable, and consistent with other risk characterdecisions throughout the risk assessment process. A number of izations of similar scope prepared by the USEPA. Risk regulatory reform bills which required risk characterization as part assessors are charged with (1) generating a credible, objecof all Federal risk assessments were introduced by the 104th Contive, realistic, and scientifically balanced analysis; and (2) gress. The purpose of this workshop was to familiarize Society of explaining confidence in each assessment by clearly deline-Toxicology members with: (1) key elements to be considered in ating strengths, limitations, uncertainties, default assumprisk characterization and (2) new advances in risk characterization tions, along with the impacts of these factors on the overall addressed by Federal and State agencies, industry, academia, assessment. Since every assessment carries uncertainties, a NRC, and Presidential/Congressional Commission on Risk Assesssimplified numerical presentation of health risk is always ment and Risk Management. Furthermore, the main objective was incomplete and often misleading. Characterizing risk to to engage the audience in discussing the proper role of science include qualitative information should be encouraged to in risk assessment-risk management...
New, powerful gastric secretory inhibitors, such as omeprazole, produce gastric cancer in rats. The mechanism by which the drugs elicit gastric carcinogenesis is considered to depend on the production of therapeutic achlorhydria, with subsequent release in to the circulation of peptides (such as gastrin) which are trophic to the gastric mucosa. It has been argued that the drugs do not pose a carcinogenic risk to man because the neoplastic response to gastric inhibitors in rats is a reaction to a 'toxic' insult; or because rats and humans react differently to the drugs; or because the mechanisms of gastric carcinogenesis are different in the two species. In any case, since most of the powerful gastric secretory inhibitors produce carcinoid tumours in rats, and carcinoid tumours of the human stomach are rare and largely benign, there would be no risk even if the drugs did produce proliferative abnormalities of the human stomach. Not one of the above hypotheses has been confirmed or, indeed, even satisfactorily tested. The mechanisms of the drug-induced gastric carcinogenesis in rats has not been defined and consequently it is not even possible to attempt to guess the risk to man. Until information is available about the effects of the powerful gastric secretory inhibitors on the proliferative indices and patterns of the human gastric mucosa, the drugs must be categorized as too dangerous to use therapeutically, especially since the proposed therapeutic benefits are minimal.
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