Friday,
November 29, 2002
Testing with children will be valuable
The federal government is taking public
comments until Monday on a plan to test the effectiveness of a diluted
smallpox vaccine. There shouldn't be any informed opposition to the
plan.
Researchers at Cincinnati Children's Hospital Medical Center and
Harbor-UCLA Medical Center in California want to know whether diluted
smallpox vaccine is effective in children aged 2 to 5. The only way to
know for sure is to test the vaccine in a small group of children.
It's the same way that nearly all medicines are tested.
Smallpox vaccine is effective. It is made from the bacteria that
causes a less serious but related illness, cowpox. The body makes
antibodies to it which fight smallpox. Similar vaccines have been used
for more than 200 years.
There hasn't been a case of smallpox reported in the world since
1977. But smallpox is again a world concern because it's possible that
some nation or group would use it as a biological weapon to infect and
kill soldiers and civilians in other countries.
In preparing for such a possibility, it's been found that a diluted
vaccine works in adults. But the diluted vaccine's effectiveness is
not known in children.
So a test study has been proposed, using 40 children who would be
volunteered by their parents - 20 in Cincinnati, 20 in Los Angeles.
Because of the war against terrorism, the plan has attracted public
attention. There is a 1 in 1 million chance that a child could die
from the vaccine and a 3 in 1 million chance of causing encephalitis.
But questions over the ethics of using children in a study of
medicine that may never be used sent the proposal to a government
agency. The Office for Human Research Protections, a unit of the
Department of Health and Human Services, is expected to render a
decision in early 2003 on whether the study should be done.
The risks in this study are the same kinds involved in testing
other medicines. Nearly every medicine that is approved for human use
has already been tested, usually on animals and then on humans. It's
the only way to find out for sure how well the medicine works and what
side effects it may have.
Yet vaccinating children before they go to school has been
well-established public health policy for generations. It's likely
that many of the children will never be exposed to some of the
diseases they've been vaccinated against.
It's the principle of being prepared for possible infection.
The risk of this test is small, the benefits obvious. It is
doubtful that those who oppose this testing program would really want
to use an unproven vaccine after a nation's children are exposed to
deadly smallpox and hope it works.
The government, assuring that all appropriate controls are used,
should allow this test to proceed.
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