this article comes just days after Amy Goodman of Independent TV's
DemocracyNow (democracynow.com) just exposed the NY portion with
public officials directly questioning or as head of the ACF

The show had was much more revealing than this article with inside
information as well as coverups the numbers of children the
suspected possible BAD outcomes and possiblilties that many children
DID NOT HAVE HIV but were in the program anyway and the major drug
company's disclaimer statement (glaxol smith-kline if I remember
right I would need to look at my notes)

http://www.oregonlive.com/newsflash/washington/index.ssf?/base/politi
cs-1/1115308338281000.xml&storylist=washington

AP: Feds tested AIDS drugs on foster kids
5/5/2005, 9:00 a.m. PT
By JOHN SOLOMON
The Associated Press


WASHINGTON (AP) — To gain access to hundreds of HIV-infected foster
children, federally funded researchers promised in writing to
provide an independent advocate to safeguard the kids' well-being as
they tested potent AIDS drugs. But most of the time, that special
protection never materialized, 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 that patients
suffered side effects such as rashes, vomiting and sharp drops in
infection-fighting blood cells, and one reported a "disturbing"
higher death rate among children who took higher doses of a drug,
records show.

The government provided special protections for child 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, including those in Illinois and New York,
required researchers to sign a document agreeing to provide the
protection regardless of risks and benefits.

However, researchers and foster agencies told AP that foster
children in AIDS drug trials often weren't given such advocates even
though research institutions many times promised in writing to do so.

Illinois officials believe none of their nearly 200 foster children
in AIDS studies got independent monitors. 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 they didn't provide advocates for foster kids.

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 benefit directly because
the drugs already had 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.

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.

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.

NIH, the government health research agency that funded the studies,
did not track researchers to determine whether 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.

The U.S. Office for Human Research Protections, created to protect
research participants after the notorious Tuskegee syphilis studies
on black men in the 1930s, is investigating the use of foster
children in AIDS research. The office declined to discuss the probe.

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.

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 carefully
monitor potential side effects. Foster children, they said, need the
added protection of an independent advocate.

"If they did not fulfill that requirement, how can you be sure the
community participant really got the benefit and the informed
consent that is needed," said Michelle Lopez, a New Jersey woman
whose daughter has participated in drug trials.

"I was very concerned about that because the argument we are getting
is the kids are getting better and we are enhancing their lives, but
none of these drugs save these kids lives," she said.

Many studies that enlisted foster children involved early Phase I
and Phase II research — the riskiest — to determine side effects and
safe dosages so children could begin taking adult "cocktails," the
powerful drug combinations that suppress AIDS but can cause bad
reactions like rashes and organ damage.

Some of those drugs were approved ultimately for children, such as
stavudine and zidovudine. Other medicines were not.

Illinois officials confirmed two or three foster children were
approved to participate in a mid-1990s study of dapsone. Researchers
hoped the drug would prevent a pneumonia that afflicts AIDS patients.

Researchers reported some children had to be taken off the drug
because of "serious toxicity," others developed rashes, and the
rates of death and blood toxicity were significantly higher in
children who took the medicine daily, rather than weekly.

At least 10 children died from a variety of causes, including four
from blood poisoning, and researchers said they were unable to
determine a safe, useful dosage. They said the deaths didn't appear
to be "directly attributable" to dapsone but nonetheless
were "disturbing."

"An unexpected finding in our study was that overall mortality while
receiving the study drug was significantly higher in the daily
dapsone group. This finding remains unexplained," the researchers
concluded.

Another study involving foster children in the 1990s treated
children with different combinations of adult antiretroviral drugs.
Among 52 children, there were 26 moderate to severe reactions —
nearly all in infants. The side effects included rash, fever and a
major drop in infection-fighting white blood cells.

New York City officials defend the decision to enlist foster
children en masse, saying there was a crisis in the early 1990s and
research provided the best treatment possibilities. Nonetheless,
they are changing their policy so they no longer give blanket
permission to enroll children in preapproved studies.

"We learned some things from our experience," said Elizabeth
Roberts, assistant commissioner for child and family health at the
Administration for Children's Services. "It is a more individualized
review we will be conducting."