Age discrimination in trials and treatment: old dogs and new tricks.

Abstract

It is common for drug trials to exclude older people, usually over 65 or 70. Many of the drugs which are successfully tested are then registered and become available either on prescription or over the counter. Healthcare professionals are left in a bind: either they do not prescribe the medications to those in the excluded age groups because of the lack of age-relevant data, or they prescribe, off-label, despite the lack of systematic collection of age-relevant data. Alternatively, if the pharmaceutical is available without prescription, older people may be buying without any inkling or warning that the drug was never tried on people of their own age. Either way, our older fellow citizens are not getting the same ethical treatment as younger adults. Compounding the questionable ethics involved is the fact that as age increases, the ratio of women to men increases. Amplified by the fact that women consume more pharmaceuticals than do men, the discrimination takes on a distinctively sexist slant as well as an ageist one. Two other groups often excluded from trials are (a) minors and (b) pregnant or lactating women. But the rationale for their exclusion is different from that for the exclusion of seniors. A major reason for these two groups' exclusion is the legal incapacity of the young to consent and the concomitant flow-on liability for injuries and damages to the youngsters. The potential exposure to later legal claims may be a strong motivating force for pharmaceutical companies to exclude from their trials people without legal capacity to consent. But the third group of people, seniors, is excluded by reference to their seniority not their inability to give informed consent. While the other two exclusions can be explained in terms of moral, social and legal conventions, seniority alone is based on two practical concerns: firstly, whether seniors are likely to die before the end of the trial, and secondly, the compounding effects of the so-called diseases of old age. Together, these concerns are thought to justify seniority exclusion in the interests of clean science. This paper examines some of the ethical issues, the implicit ageism and sexism in the exclusion of seniors. The discussion considers the ethical consequences of the exclusion, where seniors are either taking drugs in the absence of evidence-based trials on their age groups, or are denied drugs because they are untried on the age groups.