Risk Assessment Tools in Decision Making

Risk Assessment Tools in Decision Making

Article Review

Risk assessment is a tool especially used in decision-making by the scientific and regulatory community. In Making Good Decisions, Peter Montague discusses the use of risk assessment, points out its lack of usefulness in his opinion, and posits that the current use of risk assessment today is largely unethical. He states that "Risk Assessment is one way of making decisions, but it is not the only way, and it is not the best way." (Montague, date unknown, p.1) Decision making in itself carries a substantial amount of risk because decisions are made in a less-than-perfect world. One never has all the information possible (Harris, 1998) and every decision charts a course into an unknown future. However, there are times where the potential for injury to people, animals or the environment in that unknown future should be evaluated and be considered in the development of alternatives. It is particularly important in the determination of appropriate courses of action when introduction of new chemicals into an environment or population is being contemplated.

Montague uses the four-step process definition of risk assessment described by the National Academy of Sciences and then discusses how each step has failed to have an impact on 'good decisions.' In step 1, Hazard Identification, he states that toxic 'endpoints' such as cancers and reproductive toxicities "are simply ignored." He continues in step 2, Dose-Response Assessment, with discussion of the effects of dose size on risk. He implies that because there are many ways to estimate or extrapolate the data from lab animals to humans, it causes the results to be manipulated until the answer that supports a particular plan of action is found. He implies that, at least informally, an alternative has already been isolated for implementation. In step 3, Exposure Assessment, Montague again asserts that "many sources of exposure are usually ignored." Finally in step 4, Risk Characterization, the type of population to be affected is analyzed. Here, Montague declares that "in practice, the characteristics of a particular population are usually ignored and averages are used instead." (Montague, date unknown, p. 2)

Montague continues in the remainder of the article to dispute the utility of risk assessment in decision-making. He alleges that "risk assessments never describe the real world" and "most people cannot understand or participate in a risk assessment" because it is a "mathematical technique." He further maintains that risk assessment is unethical because it "has often been used to impose bad decisions on people-of-colour [sic] communities, on indigenous people, and on communities [and populations is implied] that lack political power." (p. 4) Montague's sure-fire cure to all of these allegations is getting the public "involved in describing and discussing all reasonable alternatives" because unless "discussion of reasonable alternatives" and "selection of the least-damaging alternative" occurs, the final decision will be an unethical one.

Discussion

Montague uses a number of generalities and arguments that I found to be without serious merit. His comments border on the "slippery slope" of risk assessment as the main reason environmental damage occurs and that certain population groups have been exposed to toxic chemicals and treatments. Nowhere in the course of the article does Montague quote empirical data or published studies to back his claims that "reliance on risk assessment harms democracy" and that "risk assessment is inherently misleading." Many of the conclusions he makes are insufficiently supported by the premise arguments preceding them. His tone at times is demeaning, i.e, "most people cannot understand risk assessments," and accusatory of the scientific establishment.

Risk assessment and management, though unsupported by Montague, do have their place in certain types of decision-making processes. Risk assessment is more than just a liability assessment. Risk analysis has long been used in the scientific and environmental community in the evaluation of alternatives, which is directly contradicted by Montague. He points out that risk analysis examines how much damage will be done, rather than searching for alternatives which will do no damage. Because of this, he states that Risk Assessment is then unethical. However, I assert that the function of risk analysis, is to determine which alternative will do the least damage.

In too many situations, particularly those which come to mind from the pharmaceutical industry, there is often no alternative available without any risk. Even good and effective drugs have potential risk to do harm--whether by idiosyncrasy or misuse. To say that because all alternatives carry risk, the decision-making process associated with use of any of those risky alternatives, is unethical could leave one with no options at all to choose from. Where then is a decision going to come from? In some respects, even indecision becomes a decision not to decide.

For example, consider a cancer patient for whom radiation, surgery or other more traditional therapies has not been successful. An experimental drug with a significant risk profile and side effects is available. The cancer patient must weigh whether the likelihood of a response to the new drug is worth the risk (chance) that it will be unsuccessful like the previous more conventional treatments. The patient trusts that during research and development of the product, evaluation of its toxicity has already occurred. The patient, in fact, in consenting to use an experimental treatment, is told about all the toxic endpoints (hazards as Montague calls them) known to the researcher, what if any dose-related effects have been seen thus far, what his or her exposure will be (how much will he or she receive?), and does he or she match the population profile for which a response may be useful. The clinician, then, must inform