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  1. RealGanjaMan
    Government tested AIDS drugs on foster kids

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    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.

    Research conducted in 7 states
    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 as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.

    In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.

    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 required the protection regardless of risks and benefits.

    Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and “act in the best interests of the child” for the entirety of the research, the law states.

    Children often not given advocates
    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 to do so to gain access to the children.

    Illinois officials believe 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 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 caused by experimental treatments.

    'The most vulnerable subjects imaginable'
    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 directly benefit because the drugs had already 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.

    Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT — an effective AIDS treatment — for children.

    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.

    Better access to drugs?
    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.

    Safety review boards overwhelmed
    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. An ethicist who served 22 years on such boards said they lack the resources to ensure the safety of foster children.

    “Over the last half century, IRBs have basically broken under the strain of some of the structural changes in research,” said Gregory E. Pence, a University of Alabama-Birmingham bioethicist.

    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.

    NIH said it considers patient safety its top priority and awaits the outcome of the investigation. “If we find that patient protections need further strengthening, we will take action to do so,” spokesman John Burklow said.

    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.

    “Our policy was to try and contact the (biological) parents because it was fairly common when we got done the foster kid would go back to the parents,” said Dr. Ross McKinney, a pediatrics AIDS expert at Duke University.

    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.

    'Someone needs to be watching'
    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.

    “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.

    “I think that’s the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time,” 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.

    Reports of serious side effects
    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.

    Officials defend research
    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.”

    Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers.

    “We talk about it. Then they come the next time. There is no rush,” explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children.

    Kline, the Texas researcher, added: “I never wanted a parent or guardian to ever say 'yes' simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family.”


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    Very Interesting... Never heard of this before.

    Heard of something like this before, but I believe it took place in canada :confused:

    -RGM

Comments

  1. old hippie 56
    Too bad that articles like this are often overlooked or put to the side for other so-called popular news items.
  2. rxbandit
    this seems to remind me of the leading suppressed theory for the origins of AIDS were millions of unknowing children from the congo were dosed by an unscroupolous doctor who made a polio vaccine then breed the viral based vaccine in infected chimpanzee kidneys using tissue culture and virology, heres a quick article on that...
  3. rxbandit
    Polio vaccines and the origin of AIDS: some key writings

    Go directly to key publications and latest developments.

    Overview of the theory

    One theory of the origin of AIDS is that it developed from contaminated vaccines used in the world's first mass immunisation for polio. There are a number of reasons why this theory is plausible enough to be worthy of further investigation.
    • The location coincides dramatically. The earliest known cases of AIDS occurred in central Africa, in the same regions where Koprowski's polio vaccine was given to over a million people in 1957-1960.
    • The timing coincides. There is no documented case of HIV infection or AIDS before 1959. Centuries of the slave trade and European exploitation of Africa exposed Africans and others to all other diseases then known; it is implausible that HIV could have been present and spreading in Africa without being recognised.
    • Polio vaccines are grown (cultured) on monkey kidneys which could have been contaminated by SIVs. Polio vaccines could not be screened for SIV contamination before 1985.
    • Another monkey virus, SV-40, is known to have been passed to humans through polio vaccines. A specific pool of Koprowski's vaccine was later shown to have been contaminated by an unknown virus.
    • In order for a virus to infect a different species, it is helpful to reduce the resistance of the new host's immune system. Koprowski's polio vaccine was given to many children less than one month old, before their immune systems were fully developed. Indeed, in one trial, infants were given 15 times the standard dose in order to ensure effective immunisation.
    If this theory is correct, it has serious ethical, health and policy implications. In particular, it points to the danger of interspecies transfer of material through vaccinations, organ transplants, etc., which could lead to new variants of AIDS as well as other new diseases. As well, studying the theory may lead to insights about responding to AIDS and preventing new diseases.
    However, there has been no sustained attempt to test the theory. This could be done, for example, by testing stocks of polio vaccine for the presence of SIV. An offer to undertake tests was made as early as 1991; only in 2000 were some samples tested, and then only US-made vaccine. Another possibility would be to test stored blood samples in Africa from before 1950. If HIV is found, this would undermine the theory.
    Although the theory has not been properly examined, many people seem to believe it has been refuted. Hilary Koprowski published a letter in Science in 1992 attacking the theory. In 1993, Rolling Stone, which had published a widely publicised article by Tom Curtis about the theory, published an "update", interpreted by Science as a retraction. The public record thus suggests that these contributions have been the final word.
    Actually, this appearance of "refutation" was due to the exercise of power, not scientific judgement. Science refused to publish a reply to Koprowski's letter by Curtis and, later, another reply by eminent biologist W. D. Hamilton. Nature has received substantial submissions about the theory from at least six scholars but has not published any of them. Rolling Stone's "update" was the aftermath of a legal action for defamation by Koprowski against Rolling Stone and Curtis. Thus, it has been editorial prerogative and legal action that have given the impression that critics of the theory have been unanswered.
    To help rectify this situation, provided here are a number of key documents presenting the theory and commenting on it. Also given is a list of publications about the theory. This material is provided by Brian Martin who as a social scientist has been following the theory since 1991. It is part of a page on suppression of dissent. Comments and additional contributions are welcome.
  4. Forthesevenlakes
    rxbandit, swim would be interested in discovering how genetically similar the AIDS virus and polio virus are, swim realizes that virii can mutate and change rapidly under the right conditions, but thinks that if the AIDS virus did indeed come from a polio vaccine (which would be a weakened form of the virus), there should be some genetic similarities. thats an interesting theory though...

    on topic: swim is appalled that researchers could get clearance to do this when the side effect profiles were probably unknown or nonexistent. children generally have some extra protection when it comes to enlisting them as research subjects, since oftentimes they have no idea what theyre really getting into, but swim is shocked to see that this was not the case here. unfortunately this story will probably go disregarded by most, and no researcher heads will roll.
  5. rxbandit
    actually the virus had no real similiarity to the polio virus. the problem arose in the fact they used chimpanzee kidneys of chimpanzees effected by the SIV(simian immuno virus) as their tissue culture substrate. more or less they grew the polio vaccine in/on infected monkey kidneys hence contaminating the vaccination. they used this method to scale up the production on site to administer the serum so depending on the substrate used for the tissue culture the vaccine might or might not be infected. only the vaccines that used the chimpanzee's instead of lower monkeys got infested with SIV and the tissue culturing made the SIV virus easier for the human body to accept. its really a complicated topic that makes alot of sense if you look at all of the evidence. the messed up part was the doctor who undertook these studies more or less lost his practicing license and was ridiculed for secretely testing humans in america so he got a big pharmaceutical firm to back him and take his operation to the congo. his polio study actually invented the field of virology and revolutionized tissue culture.
  6. rxbandit
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