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PROPOSAL TO TEST SMALLPOX VACCINE IN YOUNG CHILDREN
SETS OFF ETHICS DEBATE
By Sheryl Gay Stolberg
New York Times
November 4, 2002
WASHINGTON, Nov. 4, 2002 -- Federal health officials are proposing to
test the smallpox vaccine in toddlers and preschoolers, a proposal so
fraught with ethical questions that the Food and Drug Administration is
seeking comment from the public before allowing the experiment to proceed.
The vaccine is made of a live virus called vaccinia and poses a risk of
serious complications, even death. At issue is whether the threat of a
bioterrorist attack using smallpox -- a disease that was eradicated in
humans two decades ago -- is serious enough to warrant exposing children
to those risks.
"Everyone agrees that the risk of smallpox through a bioterrorism event
is not zero," said Dr. Karen Midthun, who supervises vaccine research for
the food and drug agency. "But how small or how large is that risk? Given
that it is so difficult to quantitate, it makes it difficult to know
whether there is potentially any benefit to these children."
Dr. Midthun said the agency would take public comment on the proposal
through the end of this month. After that, she said, Tommy G. Thompson,
the secretary of health and human services, and Dr. Mark B. McClellan,
the new commissioner of food and drugs, will decide whether to approve
The proposed pediatric study comes as President Bush is considering
whether, and how, to make smallpox vaccine available to the public for
the first time since 1972, when routine vaccinations were suspended. Mr.
Bush is considering proposals to make the vaccine available first to
health care workers and eventually to all Americans.
The pediatric study would enroll 40 children, ages 2 to 5, at Children's
Hospital Medical Center in Cincinnati and Harbor-U.C.L.A. Medical Center
in Los Angeles. Because the vaccinia virus can spread, posing serious
risk to people with immune deficiencies or skin conditions like eczema,
the children will be required to stay home from day care or preschool for
a month after inoculation.
The National Institutes of Health has been testing the government's aging
stockpile of 15.4 million doses of smallpox vaccine to see if it can be
used safely in adults, and to see if it remains effective when diluted;
research suggests that it does. The goal of the pediatric study is to
determine if the same is true in children.
"If we had an attack and we had to use the vaccine in children, you would
see a lot of eyebrow-raising if we didn't know the effects," said Dr.
Anthony S. Fauci, director of the National Institute of Allergy and
Infectious Diseases, the branch of the N.I.H. that is proposing the study.
But the study is drawing objections from some experts. Among them is Dr.
Paul A. Offit, chief of infectious diseases at Children's Hospital of
Philadelphia, who believes the benefits of testing the vaccine do not
outweigh the risks. Noting that the vaccine offers protection when given
up to four days after exposure, Dr. Offit said he believed testing in
children was ethical only after an actual case of smallpox had been
"Smallpox doesn't exist in this world, so the benefits are solely
theoretical," said Dr. Offit, who serves on a panel of experts that
advises the Centers for Disease Control and Prevention on vaccine policy.
"That, in combination with the fact that the vaccine has known and,
albeit rarely, severe side effects leads one to question whether you can
ethically do that study."
When the smallpox vaccine was last in use, 15 people out of every million
who received it experienced potentially life-threatening complications --
a risk that experts have said holds true for both adults and children. In
children, Dr. Fauci said, the most serious risk is encephalitis, a
potentially deadly disorder that causes inflammation of the brain.
Dr. Fauci cited statistics from a 1968 study that tracked 5.6 million
people who received smallpox vaccine, 3.3 million of them children
between the ages of one and four. Among these youngsters, 10 developed
encephalitis and three -- all under the age of one -- died from it.
Federal regulations impose strict oversight on clinical trials in
children. If studies pose more than minimal risk to children, they may go
forward only if they offer direct benefit to the child or enhance
understanding of the child's disorder. If those conditions are not met,
the studies are subject to federal review, including an evaluation by
outside experts and public comment of the sort the F.D.A. is seeking.
Among the experts consulted for the pediatric smallpox trial is Dr. Neal
Halsey, director of the Institute for Vaccine Safety at Johns Hopkins
University in Baltimore. Dr. Halsey said he had concluded that the study
was ethical, but only if it was "done very carefully and done in a very
limited number of children."
But he said he had chosen not to take part in the national institutes'
trial. "I did not care to be involved in exposing children to the known
risks of the vaccine in the absence of clear benefit," Dr. Halsey said.
Although the government has contracted with the pharmaceutical industry
to buy a new version of the smallpox vaccine, the vaccine to be used in
the pediatric study comes from an aging stockpile of 15.4 million doses
manufactured by Wyeth-Ayerst and donated to the government.
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