By Deborah Cho
We often determine the value of a particular medical intervention, product, or protocol by weighing its risks against its benefits. If the risks are outweighed by the benefits, then the measure is given the green light. However, risks and benefits are not easily measured nor are they readily comparable. Countless issues arise when calculating the risk, or harm, of a measure. Must we consider the potential risk to the specific individual in question, or is consideration of risk to the average individual enough? Similarly, should individual preferences be considered when deciding how much weight ought to be assigned to the risk? Are relevant harms only those that are immediate and occur proximately from the measure, or is any future harm, no matter how attenuated, that results to be a part of the equation? These questions and many more in the same vein can also be asked regarding benefits.
To these questions, there do not seem to exist satisfactory answers. Even more difficult is the determination of the overall value of a measure that is made after weighing its risks against its benefits, as risks and benefits are measured in incomparable units and manifest in very different ways. Despite these difficulties, this calculation is regularly done in medicine, public health, and research. Though I agree that benefits should outweigh risks and that probing questions ought to be asked before a measure is pursued, perhaps the current model centered around the risk-benefit analysis is too flawed to be useful.
In my Law of Research class, I recently read an older yet very relevant article on the incommensurability of risks and benefits that nicely illustrated this idea in the context of research. The article questioned whether an accurate or meaningful comparison of risks and benefits could ever truly be made by research ethics committees. Although the article is written in the context of research specifically, it seems that all the issues with applying a risk-benefit analysis in research ethics extend to other areas of health care and even beyond as well. Those issues are that risks and benefits may accrue to different people and that they may affect different domains of one’s health status that are not easily commensurable.
We can easily see how a public health measure, such as mandated vaccination, could also face these same issues. It is also possible to consider a personal medical intervention raising similar problems. For example, the risks of an emergency operation could potentially include the negative effects that the patient’s ability to continue at his job will have on the people around him while the benefits could include his financial stability. Meaningful weighing of the risks and benefits of the operation would therefore include much more than just the likelihood of a successful operation and the potential for surgical complications. As in the context of research, risks and benefits in the greater world of health care, where personal values vary wildly, seem to be unquantifiable and ultimately incommensurable.
Taking this idea one step further, I question whether the calculation of risks and benefits is ever beneficial when dealing with health. In some circumstances, the outcome is already overwhelmingly apparent so that such a calculation is unnecessary. In other situations, assessment of the factors considered and the weight assigned to those factors will undoubtedly be incomplete and could even lead to unwise decisions if we insist on following the instructions demanded by our flawed risk-benefit analysis. In order to truly benefit patients and the public as a whole, it may be necessary to step outside of this framework we have become so accustomed to, instead of forcing our decisions to reduce to a mathematical formula.