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COMMENT BY:
Arthur Hammond-Tooke, President, Multiplex International Trade & Technology Services
Consigning substances, which have both potential benefits and hazards in the daily lives of Americans to a "reviewed but not listed" category in the DHHS Report on Carcinogens, falls short of the Congressionally mandated federal agency directive to provide useful health information to the public. I write to support and amplify Center for Regulatory Effectiveness (CRE) January 28, 1999 suggestions on this issue to the National Institute of Environmental Health Sciences. Far from being confined to exceptional substances such as pharmaceuticals and alcoholic beverages, trading off known costs and benefits is the stuff of responsible adult life. In fact, teaching our children to cross the road, learn to drive, succeed in the classroom or the sports field, involves developing their capacity to make appropriate choices based on an understanding of the likely consequences. The question is whether the information provided by federal agencies helps or hinders the decision processes of Americans already using this information to make health-related lifestyle choices. This goes beyond the accuracy and transparency of the federal agency data delivery process commented upon by James Miller III in the Washington Times, July 15, 1999. Information quality is really validated by the quality of the decision process supported by the data, and the way it is presented. The debate over postmenopausal estrogen use provides a classic example of confused public health messages. Without information concerning the relative risks, women were confronted with information in the consumer press that hormone replacement therapy both reduces the risks of heart and increases the risks of breast cancer. The public health information was not presented that the cardiac benefits would extend the lives of millions of women compared to the several thousand with elevated breast cancer risks. Furthermore, the real personal health question was not addressed at all: namely, which subpopulations face such elevated risks that hormone replacement therapy is contraindicated. The postmenopausal estrogen example reflects the fact that tamoxifen is not an exceptional case of the pharmaceutical paradox that a medication can provide both a cure for and cause of disease under differing circumstances. It is knowledge of these specific circumstances, and the disease management implications that are important; rather than that tamoxifen may both cause and cure two different forms of cancer. Even aggregate relative risk data in an "expanded listing," which conveys that "the anti-cancer benefits on taxoxifen greatly exceed the cancer risks," may fall short of the risk/benefit relationship information needed to inform breast cancer patients and healthcare providers. In recent years, beverage alcohol health literature has documented the aggregate cardiovascular benefits of moderate alcohol consumption(1) especially among older population groups. Despite the negative health effects of underage drinking, drunk driving, alcoholism, cirrhosis, and chronic disease due to alcohol abuse, Department of Health and Human Services (HHS) acknowledged the beneficial cardiovascular effects of moderate consumption in its' 1997 Ninth Special Report to the U.S. Congress on Alcohol and Health(2). However, HHS limited the probable benefits to consumption not exceeding 20 to 30 grams per day, without mention of factors such as sex, body mass, tobacco use, historical consumption patterns, and other factors known to affect the risk/benefit trade off. HHS is concerned not to promote beverage alcohol use. Indeed, some individuals should never consume alcohol. Long-term alcohol consumption may also be hazardous to an individual with such a high alcohol tolerance that his sustained consumption level (perhaps many times the daily HHS recommended limit) results in chronic disease after many decades. Arguably, the second of these cases, rather than the first, needs to be made aware about the carcinogenic risks of alcohol use. At a given point in time our state of knowledge about disease causation and mitigation may be insufficient to provide optimum disease management prescriptions to public and personal health. This unfortunate fact does not justify a shift in the information matrix so that the only information available is that exposure to a particular substance may cause cancer, for instance. Simply warning about exposure by citing a hazard does not go far enough to improve health outcomes. In fact, extreme avoidance behavior, litigation, and political pressure on government to lessen exposure are likely (and rational) consumer responses to health information presented in this truncated form. Congress has specifically directed that the National Toxicology Program Report on Carcinogens should provide information regarding "estimates of the magnitude of risk each [substance] poses", the "relative toxicity" of an agent, and information on "subpopulations expected to be at higher than average risk." Can this be done within a framework that merely recites trite phrases as indicators of hazard? Is it responsible for a federal agency to avoid providing information when the substance cannot be shoehorned into such a simplistic framework? Instead, the Report on Carcinogens supports regulatory risk models that are simple linear extrapolations of animal exposure data. Congress has correctly assessed a change in consumer information needs. Consumers and health care providers now look for more sophisticated information from federal agencies that would support a disease management approach where risks and benefits are evaluated in terms of pharmacokinetic variables, immune response, and genetic factors. Perhaps Congress should sponsor a revaluation of the underlying scientific assumptions on which federal health and safety regulation has been based for the last two decades. Rapid progress is possible given our current greater understanding of decision analysis theory and of modeling complex bio-social interrelations. Sincerely
Arthur Hammond-Tooke
1. Klatsky, A.L. Epidemiology of coronary heart disease - Influence of
alcohol. Alcohol Clin Exp Res 18(1):88-96, 1994
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