Foster children AIDS Drug-Vaccine Experiments-Editorial – OpEd
Sun, 22 May 2005
An editorial in the Toledo Blade, “Pediatric Shame,” expresses the moral indignation of the community upon learning that prestigious medical research Institutions nationwide exploited the vulnerability of children in foster care to test experimental AIDS drugs and vaccines: “in test site after test site from New York City to Chicago to Johns Hopkins University in Baltimore, next to nobody bothered to provide promised advocates for the foster kids.”
Federal regulations mandate that research institutions provide children who have no parents with a personal advocate who is independent of all those who have a stake in the research.
The stakeholders include, the doctor-researchers, the medical institutions, and the guardian agencies–all of whom may have received financial compensation.
Federal regulaions state: ” The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
[45 CFR 46.409; 21 CFR 50.56] :
The editorial’s verdict: “Exploitation by any other name is exploitation. The hard truth is these children were expendable because they were already sick, had no one to defend their interests, and were available. There is nothing redeemable about that kind of world-class AIDS research, and those responsible must be held to account.”
A rejoinder by Mark Kline, Director of the Baylor International Pediatric AIDS Initiative, reflect a culture of elitism and expediency: it gives its members permission to exploit vulnerable children in foster care for use as test subjects in Phase I and Phase II experimental drug and vaccine trials.
Dr. Kline, and others in the medical research community, seem to think that he and his institution’s lawyers have a right to waive federal regulations restricting the use of children in medical experiments involving greater than minimal risks of harm.
His rationalizations reinforce the Toledo editorial verdict. It is doubtful that the following argument would hold up in court: “Would it have been fair to exclude foster children because they lacked parental advocates? I personally think it would have been wrong and an ethical lapse to do so.”
Contact: Vera Hassner Sharav
May 13, 2005
IT MAY be a far cry from the infamous Tuskegee syphilis studies on black men, but reports that federally funded medical research was done on foster children without basic advocate protection is appalling nonetheless.
Over the past two decades researchers funded by the National Institutes of Health tested AIDS drugs on hundreds of foster kids in several states.
According to an Associated Press investigation, the young subjects, ranging from infants to late teens, rarely had any anyone monitoring the drug trials on their behalf as required by federal law.
In 1983 the government mandated special protections for child wards regarding medical research. They required researchers and their oversight boards to appoint independent advocates for any foster child in test groups that involved greater than minimal medical risks and uncertain benefits.
The AIDS medications administered to the foster kids had only been tested previously on adults with known toxic effects on some.
Yet researchers frequently exempted themselves from appointing advocates for their young patients, professing the risks minimal and the benefit direct to HIV-infected children because the drugs had already been tried in adults.
But medical ethicists say the AIDS research on the foster children represents the exact circumstance implied in the law for appointing advocates.
The omission was inexcusable, said Arthur Caplan, head of medical ethics at the University of Pennsylvania.
“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.
There are those who argue that the foster children, mostly poor or minority, received care from world-class researchers at government expense that extended their lives.
They had access to drugs they otherwise couldn’t get.
“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,” said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. “From an ethical perspective, I never thought that was a stand I could take.”
He doesn’t recall appointing advocates for the foster children enrolled in his Texas studies. From an ethical perspective, doctor, that oversight is egregious.
The AP review of the blanket clinical trials performed on the foster children show many involved early Phase I and Phase II research – the riskiest.
Experts were trying to determine the side effects and safe dosages of AIDS drugs combined in potent adult “cocktails” that can suppress the disease but also cause severe reactions like rash and organ damage.
Through trial and error some of the drugs were ultimately approved for use in children while others that triggered serious side effects like blood toxicity and higher rates of death were not.
But in test site after test site from New York City to Chicago to Johns Hopkins University in Baltimore, next to nobody bothered to provide promised advocates for the foster kids.
Occasionally, the AP found, older kids – usually between 5 and 10 – were educated about the risks of the medical experiments and asked for their consent. How tragic is that?
Exploitation by any other name is exploitation. The hard truth is these children were expendable because they were already sick, had no one to defend their interests, and were available.
There is nothing redeemable about that kind of world-class AIDS research, and those responsible must be held to account.
Foster children were helped by medical trials
Saturday, May 21, 2005
By MARK W. KLINE
SOMETIMES, hindsight is not 20-20. In a recent editorial, The Blade criticized researchers who enrolled foster children with HIV in studies of anti-AIDS drugs without appointing an outside advocate for these children.
In particular, The Blade’s editorial said: “Exploitation by any other name is exploitation. The hard truth is these children were expendable because they were already sick, had no one to defend their interests, and were available.”
Nothing could be further from the truth. We did not single out these children to be the only ones who received treatment. Instead, we included them along with all other children in the same situation in studies of potentially life-saving therapies. There is a great difference.
The decision should also be considered in the context of that era, when children with AIDS died – quickly. They died young. I and others who treated them saw them die because available treatments offered only partial, short-lived benefits.
It was a devastating situation that we fought constantly. Then, beginning in the mid-1990s, increasingly potent medications began to offer hope. After much study, these medications were approved for adults, but because there were no studies in children, they were not approved for children.
Those children whose parents could afford the drugs received them anyway from physicians willing to provide treatment “off-label.”
These doctors had to guess at dosages and which medicines offered the least harm to these children.
Clearly, studies were needed to figure out which drugs at which dosages worked best for these children. And time was of the essence.
As studies of these potentially life-saving remedies began in youngsters to define these important parameters, we who treated them had a choice. We could include children in foster care or we could exclude them from the studies.
If we had elected to treat only children in foster care, then perhaps the criticism would be just. That was not the case. Most of the children in clinical trials were not wards of the state, and they and their parents agreed to the treatment.
Would it have been fair to exclude foster children because they lacked parental advocates?
I personally think it would have been wrong and an ethical lapse to do so. They had to be offered the chance for treatment.
It was, at that time, their only hope.
As we learned from the studies, these are potent therapies that can extend the lives of children with HIV.
Should we have appointed advocates for these children? Our legal experts say it was not necessary because the treatments offered potential benefit to this very vulnerable population and they were being put at no more risk than other children in the same situation.
We did not single out foster children for research. We included them in it, if they and their foster parents wanted them to be part.
In this era when there are few youngsters in the United States born with HIV and when those who have the disease receive potent treatments, it is easy to forget the desperate times when nothing we did seemed to work, and children with HIV were dying quickly.
Those memories are fresher for those of us who work in the Third World where HIV is still a rapid death sentence for millions of children who cannot get these treatments.
Do I regret including these foster children in clinical trials? No. I had to do something to help them, to extend their lives, which were as precious to me and others in my field as were the lives of those children who had parents to push us to provide them with the most potent treatments available.
Dr. Mark Kline is professor of pediatrics at Baylor College of Medicine and director of the Baylor International Pediatric AIDS Initiative.
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