by
John Solomon
The Associated Press
May 5, 2005
WASHINGTON - Government-funded
researchers tested AIDS drugs on hundreds of foster children over
the past
two decades, often without providing them a basic protection
afforded in federal law and required by some states, an Associated Press
review has found.
The research funded by the
National Institutes of Health spanned the country. It was most widespread
in the 1990s as foster care agencies sought treatments
for their HIV-infected children that weren't yet available in the marketplace.
The
practice ensured that foster children - mostly poor or minority
- received care from world-class researchers at government expense,
slowing their rate
of death and extending their lives. But it also exposed a vulnerable
population to the risks of medical research and drugs that were
known
to have serious
side
effects in adults and for which the safety for children was unknown.
The
research was conducted in at least seven states - Illinois, Louisiana,
Maryland, New York, North Carolina, Colorado and Texas - and involved
more than four dozen
different studies.
The foster children ranged
from infants to late teens, according to interviews and government
records.
Several studies that enlisted
foster children reported patients suffered side effects such as rashes,
vomiting and sharp drops
in infection-fighting
blood
cells. In one study, researchers reported a ``disturbing'' higher
death rate among children who took higher doses of a drug.
The
government provided special protections for young wards in 1983.
They required researchers and their oversight boards to
appoint independent
advocates
for any
foster child enrolled in a narrow class of studies that involved
greater than minimal risk and lacked the promise of direct
benefit. Some foster
agencies required
the protection regardless of risks and benefits.
However, researchers
and foster agencies told The AP that foster children in AIDS
drug trials often weren't given such advocates
even though
research institutions
many times promised to do so to gain access to the children.
Illinois
officials believe that none of their nearly 200 foster children
in AIDS studies got independent monitors even though
researchers signed a document guaranteeing
``the appointment of an advocate for each individual ward
participating in the respective medical research.''
New York City
could find records showing 142 - less than a third - of the 465
foster children in AIDS drug trials
got
such monitors
even
though city
policy
required them. The city has asked an outside firm to investigate.
Likewise,
research facilities including Chicago's Children's Memorial Hospital
and Johns Hopkins University in Baltimore
said they concluded
that they didn't
provide advocates for foster kids.
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
attributed to the
treatments.
Researchers typically secured
permission to enroll foster children through city or state agencies.
And they frequently
exempted
themselves from appointing
advocates
by concluding that the research carried minimal
risk and that the child would benefit directly
because
the drugs
already had been
tried in
adults.
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.
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.
Research and foster agencies
declined to make foster parents
or children
in the
drug trials
available
for interviews,
or to provide
information
about individual
drug dosages, side effects
or deaths, citing medical
privacy laws.
Other families who participated
in the same drug trials
told AP their
children
mostly
benefited but parents
needed to
monitor potential
side effects carefully.
Foster children, they said,
need the added protection
of an independent advocate.
``I
don't believe a foster care parent can do it,''
said Vinnie
DiPoalo,
a New Jersey
woman
whose 10-year-old
adopted son has
participated in three
AIDS drug trials.
``There are informed
consents that have
to be signed.
There are follow-up
blood
appointments.
... Someone
needs to
be watching all the
time.''
ON THE WEB
• Records: To read some of the documents relevant to The AP's review, point
your
Web browser to wid.ap.org/inv/foster.html
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