Risk Assessment Reform: Is It for Real?

Dr. Gori seems opposed to anything he cannot observe and count. His notions about scientific theories are hard to understand in a trained scientist. He states “Predictive knowledge-not guesses-is what sends men to the moon, builds skyscrapers, flies airliners, runs computers, provides effective medicines and all technological improvements that enrich our lives.” Does he actually believe that scientific knowledge showed people how to build the first skyscrapers, aircraft, etc.? Does he think there is no “art” in the design and operation of space craft and computers? Does he think that all or even most medicines are designed from scientific knowledge rather than trial and error? All of these human achievements depend on risk analysis. Drugs are toxic, the Food and Drug Administration and the individual physician must balance the potential harm against benefits. The moon landings required a careful risk analysis of which challenges were likely to arise during the mission, and what backup and other systems should be provided to decrease the risks of death. Human activity, from driving your car to deciding what to eat, depends on risk analysis. Dr. Gori focuses his comments on health risk assessments, particularly carcinogenic risk analyses. His criticism of giving animals the maximum tolerated dose will not come as news to Bruce Ames. His reservations about interspecies extrapolation are well known to biologists (Lave et al., 1988). Scientists have been addressing these criticisms, seeking knowledge about mechanisms that would permit better interpretation of high dose or animal data. The work on d-limonene exemplifies what is possible. He states “Epidemiologic meaning is conjured out of speculative reports that are often weaker than background noise. Such imaginary data are then manipulated in a framework of arbitrary guesses-the official default assumptions-and the outcomes are improperly styled as