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Recently, an article stating that a pesticide study that was
to be have been conducted on children had been dropped (The Buffalo News,
April 9, “Pesticide Study of Children Dropped” by John Heilprin).
Apparently, the Environmental Protection Agency (EPA) was anxious to get
information regarding the effects of pesticides on children. The study group
was allegedly to be comprised of low-income minority neighborhood in Florida
who would receive, as entitlements for participating, $970.00, a camcorder,
and children’s clothing for each of the sixty children participants.
The Acting Administrator of the EPA elected to cancel
the proposed study. Why, you might ask? After it became apparent that his
senate confirmation as administrator of the EPA was in jeopardy if the study
had gone forward, the acting administrator apparently felt that the study
was not such a good idea. Conflict of interest, to be sure. Who was to
benefit—the children or the Acting Administrator—by the decision to stop the
proposed study? It is unclear, but at least the children were spared the
chemical and pesticide exposure. And perhaps the Acting Administrator was
offered the new post. As a bioethicist, I shudder at the notion of such
behavior.
Unfortunately, such a scenario involving our children is not rare. Beginning
in 1956, medical luminaries deliberately infected mentally handicapped
children at Willowbrook State School on Staten Island with the Hepatitis
virus. The purpose of the study was to develop an effective vaccination for
infectious hepatitis. Newly admitted child patients were deliberately
infected with the virus after parental consent had been obtained under what
is now considered coerced and manipulative situations. In at least some of
the children’s cases, admission to the school was contingent upon the
‘participation’ of the child in the study. Fortunately, the experimental
unit was soon shut down.
More recently, there have been allegations of wrongdoing by the
Administration for Child Services in New York City concerning foster
children who were HIV-positive and were entered into clinical trials for
AIDS drug treatment between 1988 and 2001 (The Buffalo News, May 5, “AIDS
Drugs Tested Foster Children the Past 20 Years” by John Solomon). It appears
that the appropriate and necessary permission had not been obtained from the
parents or guardians, and, if it was obtained at all, had been coerced.
There were implications that non-participation might have triggered a
discontinuation of social benefits. Apparently, the study did not include an
independent advocate for the children involved. As a pediatrician, I tremble
when I recount these stories. One of the lead researchers brushed aside the
issues of informed consent and coercion opining that the study
medications—the best currently available (although not approved for
children)—were treatments that would otherwise not be available for these
patients. So, again I ask, who cares for the children?
Perhaps the more important question is ‘Why do these things happen?’ The
answer is relatively straightforward: doctors and scientists need
information and data that is applicable for children. After all, children
are not simply “little adults.” Children are different from adults in at
least three fundamental ways: physically, mentally, and experientially. The
ramifications of being physically different demands the development of
pediatric dosing of medications heretofore used only in adults as well as
knowledge of possible side effects of the medicines used in a pediatric
population. Pediatric therapeutic trials are required to elicit this type of
information and are often done through proposed trials carried out under the
auspices of the Food and Drug Administration (FDA). These studies are at
times frustratingly and necessarily slow because safety must be assured,
controls must be in place, and scientific conduct must be professional.
Assuming that all the appropriate safeguards are in place, who is
responsible for ensuring the well being of the children involved? If the
medical study is attempting to obtain pediatric information, then pediatric
patients must be used. Ethical concerns abound, and they are not limited to
the twin questions of who gives consent, and how consent was obtained, as in
the two actual medical studies mentioned above. Most young children simply
do not possess the informational experience and the concrete reasoning
capacity to make these decisions. As a consequence, parents and guardians
must think for them and make decisions that are in the best interest of the
child. In many cases, we must think for our children because many of them
simply do not have knowledge base or the decision making ability to reason
through the medical complications of a study. Not surprisingly, mature
adults can do no better if proper informed consent has not been obtained
(the lack of proper consent specifically makes the two examples presented
earlier in the column so egregious).
Proper consent encompasses three aspects: adequate and proper information,
the ability of the patient to decide, and the opportunity to decide without
coercion. This procedure was not followed in the examples given above, and
as a result, children were used and abused. This unethical process is a bell
that peals from the past. The Nuremberg Code was adopted by the
International War Crimes Tribunal in 1947 following the unethical and
horrific atrocities carried out by the physicians and armies of Nazi
Germany. Countless lives were taken and inhumane medical experimentation
performed without the knowledge or consent of a marginalized group of
people. While harm of this magnitude is extremely unlikely in these current
examples, it remains that the foundation of protection and consent is being
sacrificed at the altar of scientific research.
Our children are a gift and our heritage. They are not pawns in a power
struggle. Let us protect them as they cannot, in many cases, protect
themselves. The American Academy of Pediatrics has established a high
standard of parental permission associated with pediatric assent, insofar as
the child is able to understand and participate in the decision process.
This standard of care is useful, but still may be abused. Our standard of
care should be no less than the words of Christ in the New Testament: allow
the little children to come close to me, for paradise is for these precious
ones (paraphrase Matthew 19:14). CBHD
Ferdinand D. Yates, Jr., M.D., F.A.A.P., is
senior pediatrician and co-founder of Genesee-Transit
Pediatrics, LLP, and the Consultant on Pediatric, Adolescent and Neonatal Issues
for The Center for Bioethics
& Human Dignity.
Copyright 2005 by The Center for Bioethics and Human
Dignity
The contents of this article do not necessarily reflect the opinions of
CBHD, its staff, board or supporters. Permission to reprint granted as long as The Center for Bioethics and
Human Dignity and the web address for this article is referenced.
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