Assessing benefit-risk ratios


Helping individual patients and the general public to understand the benefits and risks associated with diagnostic, preventive, and therapeutic procedures is not easy. It is particularly difficult when the immediate benefits of the procedure are not evident, or when we ourselves are uncertain.

The problem is well exemplified by the recent public concern about the risks of pertussis vaccine, prompted by a National Broadcasting Company (NBC) documentary that, in the opinion of many in the medical community, grossly overestimated known risks from the vaccine and erroneously discounted its established benefits. Parts of this program were shown in Cleveland on the Today Show and other NBC programs. A combination of erroneous statements and vivid portrayal of children allegedly damaged by the vaccine unfortunately caused understandable consternation to many parents while outraging many members of the medical community. The initial response of many parents was to refuse pertussis vaccine for their children, but, happily, because of vigorous efforts by local medical societies, the American Academy of Pediatrics, the United States Public Health Service, the Food and Drug Administration, and individual physicians, the record appears to have been set straight.

This episode raises too many questions to discuss here, such as how much patients should be told and how best to do it, and the legal complexities of informed consent. Additionally, there are broader questions about the responsibility of the public media. Medically, an important question is how one assesses the benefit-risk ratio of vaccines, many of which do have some risk, as . . .



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