If a
widespread bioterrorism anthrax attack were to occur, the US would be able to
vaccinate adults but would be unable to protect children, as proper
pediatric vaccination dosages are not known. With this in mind, should the US
government involve healthy children in clinical trials to develop an
appropriate, and potentially crucial, pediatric anthrax vaccination?
The
Presidential Commission for the Study of Bioethical Issues has been engaging in
yearlong deliberation on this issue. The Commission was charged with balancing the
risk to healthy children who would participate in the study with the devastating
danger of being unprepared in case of a widespread anthrax attack.
This issue diverges
from other pediatric research dilemmas. The Belmont Report states, “Medical
research…is only justified if…there is a reasonable likelihood that this
population…stands to benefit from the results.” While it is clear that anthrax could be used as a biological weapon, an
attack might (and hopefully would not) ever occur. Thus, while treatment
developed from research is, with time, generally put to good use, the results
of this research could (and hopefully would) never prove necessary or
beneficial to the participants. Since biological warfare is not naturally
occurring like the diseases upon which most studies focus, the likelihood that
children would eventually require and benefit from the results of the research
cannot be predicted, which complicates the justification of the study.
Furthermore, children participating in other
clinical trials often stand to directly benefit
from the study, as, through the research, subjects might receive experimental
treatment for a disease from which they suffer. In contrast, an anthrax study that
involves healthy children would most likely not provide any direct benefit to
the participants. Thus, it is unclear whether or not involving these healthy
children is ethically wrong.
While anthrax
research differs from other studies because the results may never be needed, as
with all research, not completing the project could potentially cause far more
harm than does the study itself. If an attack was to occur and proper dosages
were not available, the results could be devastating.
Can the United
States in good conscience remain unprepared to protect its children—essentially
sentence its youngest citizens to a terrible fate—in case of an anthrax attack?
Or, knowing that the results of the study may never be needed and that the risk
to potential subjects might, thus, never be justified, can the US really
subject healthy children to the risks of participating in this research? And,
if so, which parents would volunteer their children as subjects? How could the
government ensure that the most vulnerable children (foster children, impoverished
children, juvenile delinquents, etc.) are not targeted as subjects due to their
easy availability? Children whose cancer is not responding to treatment might
participate in an experimental study. In contrast, what would be the incentive
for children to participate in this study? If the incentive must be
compensation, how would the researchers ensure that subjects are not
self-selected by financial desperation?
At the end of deliberations
on this multifaceted ethical issue, the commission will complete an advising
report for the President and Secretary of Health, who will then decide whether
or not to pursue the pediatric anthrax vaccination research.
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