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AIDS Drugs Tested On Foster Kids (Page 2 of 3)
WASHINGTON,
May 4, 2005



Ram Yogev, director of the pediatric HIV/AIDS
program at Children's Memorial Hospital in Chicago, examines a
former foster child who is now adopted, Friday, April, 8, 2005 in
Chicago. (Photo: AP)
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(AP) Some states declined to participate
in medical experiments. Tennessee said its foster care rules generally
prohibit enlisting children in such trials. California requires a judge's
order. And Wisconsin "has absolutely never allowed, nor would we even
consider, any clinical experiments with the children in our foster care
system," spokeswoman Stephanie Marquis said.
Officials estimated
that 5 percent to 10 percent of the 13,878 children enrolled in pediatric
AIDS studies funded by NIH since the late 1980s were in foster care. More
than two dozen Illinois foster children remain in studies today.
Some foster children died during studies, but state or city
agencies said they could find no records that any deaths were directly
caused by experimental treatments.
Researchers typically secured
permission to enroll foster children through city or state agencies. And
they frequently exempted themselves from appointing advocates by
concluding the research carried minimal risk and the child would directly
benefit because the drugs had already been tried in adults.
"Our
position is that advocates weren't needed," said Marilyn Castaldi,
spokeswoman for Columbia Presbyterian Medical Center in New York.
If they decline to appoint advocates under the federal law,
researchers and their oversight boards must conclude that the experimental
treatment affords the same or better risk-benefit possibilities than
alternate treatments already in the marketplace. They also must abide by
any additional protections required by state and local authorities.
Many of the studies that enrolled foster children occurred after
1990 when the government approved using the drug AZT - an effective AIDS
treatment - for children.
Arthur Caplan, head of medical ethics at
the University of Pennsylvania, said advocates should have been appointed
for all foster children because researchers felt the pressure of a medical
crisis and knew there was great uncertainty as to how children would react
to AIDS medications that were often toxic for adults.
"It is
exactly that set of circumstances that made it absolutely mandatory to get
those kids those advocates," Caplan said. "It is inexcusable that they
wouldn't have an advocate for each one of those children.
"When
you have the most vulnerable subjects imaginable - kids without parents -
you really do have to come in with someone independent, who doesn't have a
dog in this fight," he said.
Those who made the decisions say the
research gave foster kids access to drugs they otherwise couldn't get. And
they say they protected the children's interest by carefully explaining
risks and benefits to state guardians, foster parents and the children
themselves.
"I understand the ethical dilemma surrounding the
introduction of foster children into trials," said Dr. Mark Kline, a
pediatric AIDS expert at Baylor College of Medicine. He enrolled some
Texas foster kids in his studies, and doesn't recall appointing advocates
for them.
"To say as a group that foster children should be
excluded from clinical trials would have meant excluding these children
from the best available therapies at the time," he said. "From an ethical
perspective, I never thought that was a stand I could take."
Illinois officials directly credit the decision to enroll
HIV-positive foster kids with bringing about a decline in deaths - from 40
between 1989 and 1995 to only 19 since.
NIH, the government health
research agency that funded the studies, did not track researchers to
determine if they appointed advocates. Instead, the decision was left to
medical review boards made up of volunteers at each study site.
A
recent Institute of Medicine study concluded those Institutional Review
Boards (IRBs) were often overwhelmed, dominated by scientists and not
focused enough on patient protections. An ethicist who served 22 years on
such boards said they lack the resources to ensure the safety of foster
children.
"Over the last half century, IRBs have basically broken
under the strain of some of the structural changes in research," said
Gregory E. Pence, a University of Alabama-Birmingham bioethicist.
The U.S. Office for Human Research Protections, created to protect
research participants after the infamous Tuskegee syphilis studies on
black men, is investigating the use of foster children in AIDS research.
The office declined to discuss the probe.
NIH said it considers
patient safety its top priority and awaits the outcome of the
investigation. "If we find that patient protections need further
strengthening, we will take action to do so," spokesman John Burklow said.
AP's review found that if children were old enough - usually
between 5 and 10 - they also were educated about the risks and asked to
consent. Sometimes, foster parents or biological parents were consulted;
other times not.
"Our policy was to try and contact the
(biological) parents because it was fairly common when we got done the
foster kid would go back to the parents," said Dr. Ross McKinney, a
pediatrics AIDS expert at Duke University.
By John Solomon ©MMV The Associated Press. All Rights
Reserved. This material may not be published, broadcast, rewritten, or
redistributed.

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