ANCAPS

Subject: Feds Tested AIDS Drugs on Foster Kids Thu May 15, 2008 3:37 am

WASHINGTON -- 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."

http://www.infowars.com/articles/ps/feds_tested_aids_drugs_on_foster_kids.htm
_________________
"Taking money without permission is stealing unless you work for the IRS then it's taxation. Killing people en masse is homicidal mania unless you work for the Army then it's National Defense. Spying on your neighbors is invasion of privacy unless you work for the FBI then it's National Security. Running a whorehouse makes you a pimp & poisoning people makes you a murderer unless you work for the CIA then it's counter intelligence." R. Wilson. ANCAPS Forum Headquarters, Ancapolis

Guinea Pig Kids: How New York City is Using Children to Test Experimental AIDS Drugs

HIV positive children and their loved ones have few rights if they choose to battle with social work authorities in New York City.

Jacklyn Hoerger worked at the Incarnation Children's Center

Jacklyn Hoerger's job was to treat children with HIV at a New York children's home.

But nobody had told her that the drugs she was administering were experimental and highly toxic.

"We were told that if they were vomiting, if they lost their ability to walk, if they were having diarrhoea, if they were dying, then all of this was because of their HIV infection."

In fact it was the drugs that were making the children ill and the children had been enrolled on the secret trials without their relatives' or guardians' knowledge.

As Jacklyn would later discover, those who tried to take the children off the drugs risked losing them into care.

The BBC asked the Alliance for Human Research Protection about their view on the drug trials.

Spokesperson Vera Sherav said: "They tested these highly experimental drugs. Why didn't they provide the children with the current best treatment? That's the question we have.

"Why did they expose them to risk and pain, when they were helpless?

"Would they have done those experiments with their own children? I doubt it."

Power and authority

When I first heard the story of the "guinea pig kids", I instinctively refused to believe that it could be happening in any civilised country, particularly the United States, where the propensity for legal action normally ensures a high level of protection.

But that, as I was to discover, was central to the choice of location and subjects, because to be free in New York City, you need money.

I've had many ACS case workers tell me: 'We're ACS, we can do whatever we want'
David Lansner, family lawyer

Over 23,000 of the city's children are either in foster care or independent homes run mostly by religious organisations on behalf of the local authorities and almost 99% are black or hispanic.

Some of these kids come from "crack" mothers and have been infected with the HIV virus. For over a decade, this became the target group for experimentation involving cocktails of toxic drugs.

Central to this story is the city's child welfare department, the Administration for Children's Services (ACS).

The ACS, as it is known, was granted far-reaching powers in the 1990s by then-Republican Mayor Rudi Giuliani, after a particularly horrific child killing.

Within the shortest of periods, literally thousands of children were being rounded up and placed in foster care.

"They're essentially out of control," said family lawyer David Lansner. "I've had many ACS case workers tell me: 'We're ACS, we can do whatever we want' and they usually get away with it."

Having taken children into care, the ACS was now, effectively, their parent and could do just about anything it wished with them.

'Serious side-effects'

One of the homes to which HIV positive children were taken was the Incarnation Children's Center, a large, expensively refurbished red-bricked building set back from the sidewalk in a busy Harlem street.

It is owned by the Catholic church and when we attempted to talk to officials at Incarnation we were referred to an equally expensive Manhattan public relations company, which then refused to comment on activities within the home.

Dr Rasnick is internationally renowned for his work on numerous diseases, including cancer

Hardly surprising, when we already knew that highly controversial and secretive drug experiments had been conducted on orphans and foster children as young as three months old.

We asked Dr David Rasnick, visiting scholar at the University of Berkeley, for his opinion on some of the experiments.

He said: "We're talking about serious, serious side-effects. These children are going to be absolutely miserable. They're going to have cramps, diarrhoea and their joints are going to swell up. They're going to roll around the ground and you can't touch them."

He went on to describe some of the drugs - supplied by major drug manufacturers including Glaxo SmithKline - as "lethal".

When approached by the BBC, Glaxo SmithKline said such trials must have stringent standards and be conducted strictly in accordance with local regulations.

Battle of wills

At Incarnation, if a child refused to take the medicines offered, he or she was force-fed through a peg-tube inserted into the stomach.

Critics of the trials say children should have been volunteered to test drugs by their parents.

When Jacklyn Hoerger later fostered two children from the home where she used to work with a view to adopting them, she discovered just how powerful the ACS was.

"It was a Saturday morning and they had come a few times unannounced," she said. "So when I opened the door I invited them in and they said that this wasn't a happy visit. At that point they told me that they were taking the children away. I was in shock."

Jacklyn, a trained paediatric nurse, had taken the fatal step of taking the children off the drugs, which had resulted in an immediate boost to their health and happiness.

As a result she was branded a child abuser in court. She has not been allowed to see the children since.

In the film Guinea Pig Kids, we follow Jacklyn's story and that of other parents or guardians who fear for the lives of their loved ones.

We talk to a child who spent years on drugs programmes which made them and their friends ill, and we discover that Incarnation is not an isolated case. The experiments continue to be carried out on the poor children of New York City.

http://www.infowars.com/articles/ps/guinea_pig_kids.htm
_________________
"Taking money without permission is stealing unless you work for the IRS then it's taxation. Killing people en masse is homicidal mania unless you work for the Army then it's National Defense. Spying on your neighbors is invasion of privacy unless you work for the FBI then it's National Security. Running a whorehouse makes you a pimp & poisoning people makes you a murderer unless you work for the CIA then it's counter intelligence." R. Wilson. ANCAPS Forum Headquarters, Ancapolis