In a clinical medicinal trial, it is essential to ensure that the achieved results originate from the effects of the test drug. A placebo is an ineffectual treatment intentionally given to deceive a patient. Placebo effects, which are the result of an individual’s expectation influencing an outcome, can potentially lead to false positive trial results. Placebos are used in clinical trials to ensure that the effects subjects are experiencing are undoubtedly caused by the treatment they are receiving, and not their expectations for results. Without differentiating between these two possibilities, it is impossible to know why the subject is being affected by the trial in the way he/she is. The use of placebos in clinical research can be defended under a utilitarian viewpoint.
Utilitarianism states that moral actions are “those that result in the most beneficial balance of good over bad consequences, everyone considered” (Vaugh, 2013, p233). The use of force, even the institution of “despotism”, is an acceptable means to control the necessarily ignorant, such as “children” (Mill, 1910). Utility is “the ultimate appeal on all ethical questions” (Mill, 1910). Under a utilitarian perspective, it is morally permissible to place children in a potentially harmful circumstance if that circumstance has strong potential for improving the overall quality of life.
In application, utilitarian theory often bears out. According to Dianne Murphy, Associate Director for Pediatrics at the U.S. Food and Drug Administration, “placebos can reduce the number of children needed in a study and can ensure the most conclusive outcome” (Vaughn, 2013, p222). A utilitarian view would also attempt to minimize “all unnecessary physical and mental suffering and injury”; humaneness is a central principle in utilitarian applications (Vaughn, 2013, p233).
The application of utilitarian perspectives are not always clear, however. Recently researchers discovered that a drug called AZT (zidovudine) could reduce HIV transmission between a pregnant woman and her unborn infant (Vaugh, 2013, p232). As HIV is especially prevalent in several regions of Africa which are also in a povertous state, the question arose as to whether lower doses of AZT would be as effective as the standard doses which had been successfully given (Vaughn, 2013, p232). The best way to test this hypothesis was to administer placebo-controlled studies on HIV-infected pregnant women in the region (Vaugh, 2013, p232). While the research was successful, it is a strong example of the ethical issues surrounding placebo-controlled studies involving children. If the research was not successful, masses of children would have been born with the infection. If this were the result, then it could be said that he research effectively infected some of these children, as they were convinced to forego normal AZT-level treatment for this experiment. Whether the utility of this experiment was morally permissible was uncertain.
However, within the acceptable parameters set forth by documents such as the Declaration of Helsinki and the Nuremburg Code, it is permissible to subject children to placebos during a clinical trial. These documents assist researchers in determining whether the utilitarian value of an experiment is worthwhile overall. For example, the Declaration of Helsinki claims that placebo trials are permissible on child subjects only when there are no other treatment methods available, there exists sound reason for the trial, and the child is not placed in any risk or harm (2008). In the AZT treatment, it could be argued that all two of these standards are violated, but given a utilitarian context it can be seen otherwise. For example, while the normal AZT treatment is available, it is not widely available. For many of the children in this study, it was likely not a realizable economic option. While the children were placed in harm by being exposed to low-level AZT treatments, and others received only a placebo, this sacrifice could (and did) lead to the saving of many more lives through making AZT treatments more widespread. The low-level AZT treatment was also largely in agreement with the Nuremburg Code, which states that experiments “should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature” (U.S. National Institutes of Health, 1949). Placebos-controlled studies on children are justified under these circumstances according to the above documents, which argue for a utilitarian framework.
One might argue in opposition to the utilitarian viewpoint through a deontological – or Kantian – system. Under a Kantian viewpoint, treating humans as a “means to an end” is inherently immoral (Vaughn, 2013, p233). In a sense, Kantian theory and utilitarian theory are inverses of one another; the former will only accept means as a justification, and the latter, ends. Under a Kantian view, there are issues with the patient being lied to in the clinical trial. Subjecting individuals to be part of a control group is necessarily lying through implication; those who participate in a medicinal trial likely believe they are obtaining a chance to receive treatments on the forefront of science. Children may be exposed to experimental trials with the hope that conditions such as epilepsy and clinical depression may be cured with no real possibility of results (Jetter, 2000)…
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