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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.
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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 harmwhether 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 the patient about all other alternatives available no matter if they are likely to produce a negative effect, positive effect, or be of no effect at all. This process for the researcher is called getting informed consent;' but for the patient it is risk assessment. Risk assessment's only purpose is not to require that all alternatives be disclosed, but to determine if, in spite of the alternatives, if a chance is worth taking and any subsequent outcome may be more likely if a particular choice is exercised. Judging an option to have a certain level of risk associated with it, does not necessarily preclude its choice as a rational decision. If we consider the cancer patient again, we see that the experimental treatment is likely to be a much riskier choice; but, it may still be the most viable one since other less risky choices have been shown to be ineffective.
Montagues' argument that risk assessment is misleading and exclusionary suggests that the risk assessment process is at fault for situations where alternatives are not sufficiently developed. I disagree. I propose that these are not risk assessments' purpose. Development of alternatives occurs prior to risk assessment. One might ask what is the chance that if in choosing Alternative A, what hazards, what cumulative effect, how often, and to whom will identified risk B occur? Until an alternative is developed, a determination of any risks associated with it, and the potential of such a risk's occurrence could not be determined.
Furthermore, according to Hampshire Research Institute (HRI), "risk estimates are but one factor of sound decision-making." (2002) Where risk is involved, failure to utilize risk assessment, suggests that one has not used the full complement of tools available prior to choosing a course of action. HRI continues by saying, "Only in extreme cases will risks alone drive decision-making. A zero risk compels no action. A great risk may compel immediate action."
As far as patient risk during pharmaceutical research, Montague seems to have overlooked that federally mandated human subject protections have been in place since the Belmont report was issued in 1978. Considerable coverage has been given to the topic and several helpful tools to minimize the risk to human subjects have been in use for years. One of these, issued this year by the National Institutes of Health, uses a decision tree for scoring research applications'level of risk and whether the subject protection is adequate. (See decision tree below.)
Montague's claim that risk assessment is not the only way nor is it the best way of making a final decision could be argued perhaps. However, risk assessment tools are essential to a good decision-making process. Evaluation of risk associated with alternatives can be useful for eliminating some non-viable solutions which carry a very significant potential for injury to patients, animals or the environment. Risk assessment is not a replacement for developing many alternatives, nor is an alternative's level of risk always an indicator of its utility or lack thereof as a solution.
Hampshire Research Institute, (2002), Risk assessment overview: What it is, what it can
(and can't) do. Available at http://www.hampshire.org/risk01.htm
Harris, Robert, (1998) Introduction to decision making. Available at
National Institutes of Health/Office of Exposure Risk (April 2002), Decision Tree for
Protection of Human Subjects from Research Risk, Available at
Montague, Peter, (date unknown), Making good decisions., Available at