June 17, 2005 --
Columbia-Presbyterian Medical Center performed
drug experiments on AIDS-stricken foster kids without proper
safeguards or consent, the feds charged yesterday.
The devastating finding by the Department of Health and Human
Services was prompted by complaints filed after The Post documented
cases of children allegedly being used as "guinea pigs" at a
Catholic-charity foster home that was affiliated with the hospital.
The federal agency's Office of Human Research Protections
concluded Columbia-Presbyterian failed to determine whether it had
proper consent and safeguards for the foster kids in AIDS-drug
studies.
"When some or all of the subjects (e.g., children) are likely to
be vulnerable to coercion or undue influence, additional safeguards
have been included in the HHS regulations to protect the rights and
welfare of these subjects," the federal agency wrote the hospital.
The hospital's "records demonstrate a failure . . . to obtain
sufficient information regarding such safeguards with respect to the
enrollment of wards of the state or foster children," the agency
concluded in a letter dated May 23.
Columbia-Presbyterian said yesterday it was "in the process of
responding" to the letter and could not comment on it.
But it defended the research, which it said was part of a
nationwide network of federally sponsored trials.
"These studies, which took place in the 1990s, were instrumental
in extending lifesaving HIV treatments to children," spokeswoman
Marilyn Castaldi said in an e-mail statement.
"We take seriously our responsibility to protect children — or
anyone — who receives care at our medical center."
The Post, following research done by journalist and health
advocate Liam Scheff, reported last year that about 50 foster kids
were used in 13 experiments with high doses of AIDS medications at
Manhattan's Incarnation Children's Center. The tests were conducted
by doctors for Columbia-Presbyterian, which was affiliated with the
center until 2002.
Some of the studies involved combining six AIDS drugs in
"cocktails" for children as young as 3 months.
Jacqueline Hoerger, a pediatric nurse formerly of Incarnation,
told The Post at the time, "We were taught that any symptom we saw
was HIV-related.
"The vomiting, diarrhea, wasting syndrome, the neurological side
effects — they were dying. There was death."
Hoerger later served as foster mother to two HIV-infected sisters
from ICC and tried to adopt them.
Hoerger said that when she was allowed to take the girls, 6 and
4, home in 1998, she was horrified to discover they had become
"total wrecks" as a result of the drugs.
When she tried to wean the girls off the drugs, foster-care
social workers raided her Nyack home and took them away.
In response to last month's letter, Columbia-Presbyterian told
the feds that it was "in the process of planning steps specifically
to improve protections for children, and particularly foster
children."
It said it was increasing the resources to its Institutional
Review Boards, which monitor the safety of the hospital's
experiments, improving training for researchers, and creating a
Web-based system that ensures necessary information for patient
safety is collected.
Federal rules require researchers to provide independent
advocates to foster children involved in a narrow class of
experiments that pose more than a minimal risk and do not hold the
likelihood of improved health for the test patients. With Post
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