In a March 19
report by the Presidential Commission for the Study of Bioethical Issues, an
ethics panel tentatively gave a green light for researchers to test an anthrax
vaccination on children. This review was in response to a request from U.S.
Health and Human Services Secretary Kathleen Sibelius after a 2011 bioterrorism
preparedness exercise in San Francisco revealed that 8 million people would be
affected by an anthrax attack, nearly a quarter of them children. The problem,
as noted by agency officials, was that, if such an event of bioterrorism were
to occur, there would be no protocols in place to treat children exposed to the
bacteria. The current federal plan is the immediate distribution of
antibiotics; however, this does not provide long-term protection as anthrax
spores can pose an infection threat long after their initial release. The issue
now is trying to find an acceptable dose of the vaccine for children. This is challenging
because, although the vaccine has been in commercial production for the past 40
years and is used by adults in the military, there is no understanding of its
effect on children.
However, a
larger and perhaps more significant issue is the ethics surrounding this
decision. Research with children is ethically distinct from other research,
especially when the research in question promises no prospect of direct benefits
for participants. Children are legally and ethically unable to consent to
accept this burden. In addition, despite its use in adults, a 2008 study
reveals that adults who receive the vaccination are prone to a number of
serious side effects.
Supporters of
this decision argue that the safety and security of children is the top
priority in this effort, and with the chance of a bioterrorist attack, it is
much better to be in a position of prevention before it happens rather than
fixing the problem after it happens with lives at stake.
However, the
support for this testing of the anthrax vaccine on children is dependent on a
hypothetical situation that may never occur. In that case, the risks far
outweigh the benefits, and this goes back to the question of whether there are
direct benefits for participants of the study. It is one thing to test the
vaccine on a soldier who may potentially face an anthrax-loaded shell. In that
case, side effects such as itching, swelling, and soreness would hardly matter.
On the other hand, to ask a child to test a vaccine because of such a risk is
different and seems more ludicrous. Of all the real challenges that children
face, like abuse, neglect, obesity, and suicide, the threat of an anthrax
attack hardly seems to fit in that list, and according to Arthur Caplan, this
kind of terrorist attack is “remote at best.”
How far do we go
down the road of “what if…” conjectures? Human experimentation is a serious
topic with serious consequences, and, especially when we are making the
decision for children, the benefits better be worth the risks. In the case of
the anthrax vaccination, I question whether such a hypothetical situation
really deserves the application of the better-to-be-safe-than-sorry rule.
Sources:
http://www.usatoday.com/story/news/nation/2013/03/19/anthrax-vaccine-bioethics/1997167/
http://www.examiner.com/article/u-s-panel-tentatively-oks-testing-anthrax-vaccine-on-kids
http://vitals.nbcnews.com/_news/2013/03/19/17361790-bioethicist-no-chance-of-anthrax-vaccine-trials-in-kids?lite
2 comments:
While I understand your concern with these “what if” conjectures I disagree with your opinion that these types of tests should not be done. Although there is a huge number of dangers that children face, and admittedly many are much more prevalent than an anthrax attack, it is still extremely important to prepare for these situations.
If the study is done correctly and the children and their parents are informed and everything is done in a safe manner I see no reason this study and sties like it should not be preformed. If there were a bio-terrorist attack, which isn’t out of the picture, I would have wanted the government to do research to see how to minimize the effects of the pathogen. If, as your post says, there is no understanding of how this vaccine effects children then it would be incredibly dangerous and negligent to administer the vaccine to all the children effected after a bio terrorist attack and hope there are no long term negative side effects. Especially when researchers can see now what, if any, the negative effects are.
I think that this situation is easy enough to prepare for, so unlikely as it maybe; I see no reason not to do this research to ensure the safety of the vaccination. This is of course contingent on the fact that the study is run correctly and informed consent, to the parents and child (as best as can be done) is given and the study reduces any of the negative short term side effects as much as possible.
Bradley raises two points that supports his argument that pediatric anthrax research is permissible and should be allowed on children. First, he states that if the study is performed correctly, namely that the ethical concerns surrounding informed consent and the safety of the subject are addressed, then it should be allowed. And I am in complete agreement. If the benefits outweigh the costs, then any research should be permitted, again, assuming that the study is done correctly.
The problem with this anthrax vaccination study is that it does not outweigh the costs and does not guarantee the safety of the subject. As Arthur Caplan, head of the Division of Medical Ethics at NYU Langone Medical Center, points out, the vaccine itself involves five shots, with side effects including soreness, redness, itchiness, swelling and lumps at the injection site, rashes, headaches, and joint and muscle aches. If the child has asthma, allergies, depression, or cancer, the risks are expected to be even greater. For a risk that is minute such as a bioterrorism attack on civilians, is it really practical and necessary for a child to go through this? This is precisely what I argued in my original blog post, and Bradley has failed to bring a significant counter argument to the table.
This leads to Bradley's second point that the risk of a bioterrorism attack is possible, thus leading to the permissibility of this kind of research. However, the only bioterrorist attack that has ever taken place on U.S. soil (one week after 9/11) was launched by a rogue U.S. scientist who had worked in the Cold War biological weapons program and was one of the world’s few experts in weaponizing anthrax. In other words, the possibility of this is small. Given these facts, it still remains that the anthrax research that was passed should not have been permitted.
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