Vaccine
Testing on Kids Blocked
U.S. turns down a
Harbor-UCLA smallpox proposal for
2- to 5-year-olds.
By Charles Ornstein
Times Staff Writer
http://www.latimes.com/news/local/la-me-smallpox8apr08,1,1019886.story
LOS ANGELES
Vaccine Testing on Kids Blocked
U.S. turns down a Harbor-UCLA smallpox proposal for 2- to 5-year-olds.
By Charles Ornstein
Times Staff Writer
April 8, 2003
Top federal health officials have blocked a
controversial study proposed
by Harbor-UCLA Medical Center that would have tested the safety of
smallpox
vaccine in 2- to 5-year-old children, researchers said Monday.
After sharp criticism from patient advocates, the
U.S. Department of
Health and Human Services and the Food and Drug Administration
determined
that "there is no justification for this particular clinical
investigation
to proceed," according to a Jan. 24 letter sent to the Torrance
hospital.
The research was designed to determine whether
diluted doses of the
vaccine, which is harvested from calves' bellies, could be used in
children
without compromising its effectiveness. The study, which would have
involved
40 children in California and Ohio, had been supported by the federally
funded National Institute of Allergy and Infectious Diseases.
In their January letter, federal officials noted
that research was not
necessary because bioterrorism preparedness plans do not call for
children
to receive the diluted vaccine.
But Dr. Joel Ward, director of the UCLA Center for
Vaccine Research
at Harbor-UCLA, said the study was "too controversial."
The public "was profoundly against giving the
vaccine to children, and
the secretary of health decided that this was not worth pursuing."
A Harbor-UCLA board that reviews research
proposals involving human
subjects disagreed about whether the benefits outweighed the risks. The
board requested that the federal government step in and make a
decision,
as the law provides.
The research was to have been conducted at
Harbor-UCLA and Cincinnati
Children's Hospital Medical Center. Kaiser Permanente was to have been
one of the sources of participants in Southern California.
Hundreds of people -- including academics and
doctors -- submitted comments
to the FDA criticizing the research.
"The vaccine has tremendous, very serious,
life-threatening risks attached
to it," said Vera Sharav, president and founder of the Alliance for
Human
Research Protection, one of the staunchest critics. "There's no
justification
for exposing healthy little children to that kind of risk, by any
standards.
They should be the last ones to be put at risk."
About one or two people per million who received
the smallpox vaccine
decades ago died of side effects. As many as 52 people per million
suffered
life-threatening complications, including encephalitis, while an
additional
1,000 per million suffered reactions such as serious rashes.
The federal government has launched a three-phase
vaccination program
for adults to prepare for possible release of the smallpox virus by
terrorists.
In the first stage, now underway, health authorities are vaccinating
hospital
emergency workers and public health personnel likely to treat infected
patients first. Ward said he accepts the government's decision, but he
is concerned about the implications for future research.
"Research should not be a political contest," he
said. "I hope that
the government would not in the future take this tack of testing the
waters
of public acceptability, or science would be greatly crippled."
Copyright 2003 Los Angeles Times
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