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Federal Govt Experiments On Children
by Repost (repost [at] mail.com)
Thursday May 19th, 2005 5:00 PM
"Current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected, a Bush administration official said Wednesday."


The Bush Regime's Crimes Against Humanity Are Further Exposed By The Experiments Taking Place On Our Nation's Children That Are Immoral, Unethical & Must Be Ended Immediately!.
"Current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected, a Bush administration official said on Wednesday May 18."


Studies leave children vulnerable
Foster kids not given promised advocates.

Published Thursday, May 5, 2005

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 promised many times 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 that the research carried minimal risk and that the child would directly benefit 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 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 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, or 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 investigation.

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 that their children mostly benefited but that 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.

Associated Press.

**************
Click below for the links to the following articles...

http://news.search.yahoo.com/news/search?p=foster+children+and+experiments&ei=UTF-8&n=10&fl=0&x=wrt

1. Use of Foster Kids in Experiments Varies 
AP via Yahoo! News - May 19 4:27 AM
Current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected, a Bush administration official said Wednesday.

2. Using foster kids in experiments scrutinized 
CNN.com - May 18 1:13 PM
WASHINGTON (AP) -- Standards for enlisting foster children in federal medical experiments vary widely among the states, and the Bush administration is examining how best to protect "the most vulnerable in our population," a top government health official says.

3. Use of Foster Kids in Experiments Varies 
ABC News - May 19 4:51 AM
Federal Health Official Says Standards for Enrolling Foster Kids in Experiments Vary Widely

4. AIDS drugs tested on foster children 
Detroit News - May 18 11:26 PM
WASHINGTON -- Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them with a basic protection afforded in federal law and required by some states, an Associated Press review has found.

5. AIDS experiments on foster children unconscionable, says column in Seattle PI 
News Target - May 16 8:29 PM
Seattle PI reports that over the last two decades a number of foster children, mostly poor or minorities, were given AIDS medicines shown to cause serious side effects in adults. These drugs were apparently administered without research into safe dosage levels for children. Researchers defend the experiment...

6. HHS official says rules protect foster kids in drug trials 
Arizona Daily Star - May 19 12:15 AM
WASHINGTON - Current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected, a Bush administration official said Wed-nesday. "I'm not aware of

7. Probe of Foster Kids' Drug Trials Begins 
AP via Yahoo! News - May 13 6:12 PM
A congressional panel has begun investigating whether the government has adequate safeguards to protect foster children used in federal research after an Associated Press story detailed the use of child wards in some AIDS drug experiments.

8. Kaiser Daily HIV/AIDS Report Summarizes Opinion Pieces on NIH-Funded AIDS Drug Trials Involving Foster Children 
Medical News Today - May 14 11:03 AM
Researchers who conducted NIH-funded HIV/AIDS drug trials involving hundreds of HIV-positive foster children often did not appoint independent advocates for the children, despite policies requiring the assignments, according to a review of the studies conducted by the... Associated Press .

9. Congressional panel opens inquiry into use of foster kids in AIDS drug trials 
KRON 4 Bay Area - May 13 3:24 PM
CAPITOL HILL A congressional panel is investigating whether the government has adequate safeguards to protect foster children used in federal research.

10. Probe of Foster Kids' Drug Trials Begins 
ABC News - May 13 6:33 PM
Congressional Panel Opens Inquiry Into Use of Foster Kids in AIDS Drug Trials

13. AIDS research carries stench of past studies 
The News & Advance - May 15 9:32 PM
After the U.S. Public Health Service was exposed for conducting a hideous experiment between 1932 and 1972 on 399 black men in the late stages of syphilis, it would seem the government might be a little more careful about using humans as guinea pigs.

14. Pediatric shame 
Toledo Blade - May 13 3:46 AM
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.

15. AP Is Breaking Story Tomorrow on Use of Foster Children in AIDS Experiments 
Editor and Publisher via Yahoo! News - May 03 4:21 PM
NEW YORK The Associated Press will report on Wednesday, after more than four months of research on the use of foster children in AIDS experiments, that most of the children never got the benefit of a basic protection afforded by federal law and required by some states -- an independent advocate to monitor their care, their side effects and their wishes as they moved between homes or facilities.

16. NYC Council Hears About Involvement Of Foster Children In HIV Drug Trials 
WNBC - May 05 4:24 PM
NEW YORK -- City Council members, asking a litany of questions and chastising the commissioner who was testifying, on Thursday insisted on a thorough investigation into policies that allowed foster children into clinical drug trials for HIV/AIDS from the late 1980s to 2001.

19. Federal researchers tested AIDS drugs on foster children 
Albany Democrat-Herald - May 06 12:16 PM
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.

20. Lack of informed consent dulls good news in kids' study 
Denver Post - May 09 12:59 AM
Research conducted without permission on foster children with HIV or AIDS sounds uncomfortably like the Tuskegee Syphilis Study that withheld treatment for black men with venereal disease. It isn't.

21. Foster children used in tests of AIDS drugs 
Kansas City Star - May 05 12:05 AM
WASHINGTON — Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, an Associated Press review has found.

22. AP Enterprise: Drugs tested on foster children without protection 
The Herald-Sun - May 05 3:40 AM
Government-funded researchers tested AIDS drugs on hundreds of foster children in North Carolina and at least six other states 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.

25. Foster children used in AIDS drug testing 
Bradenton Herald - May 05 12:03 AM
WASHINGTON - Govern-ment-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 found.

26. AIDS researchers used foster children who lacked advocates 
Dallas Morning News - May 04 6:55 PM
WASHINGTON – Government-funded researchers tested AIDS drugs on hundreds of foster children over the last two decades, often without providing them a basic protection afforded in federal law, an Associated Press review has found.

27. AP Review: Feds Tested AIDS Drugs On Foster Children 
NBC 5 Chicago - May 04 2:22 PM
The government tested AIDS drugs on hundreds of foster children -- often without providing them with proper advocate protection.

28. Use of Foster Kids in Experiments Varies 
New York Newsday - May 05 6:16 AM
Thursday: Partly cloudy with highs around 70. ... Bank of America Youth Entrepreneur Expo, 199 Chambers St., 9 a.m. ... Children's health fair, Wintergarden, 3959 Broadway, 10 a.m. ... LMDC unveils design of the WTC Cultural Center, 36 Battery Place, 11 a.m. ... Opening of the Bronx Zoo Butterfly Garden, Bronx Zoo, 11 a.m. ... NYPIRG Straphangers Campaign protests MTA station repairs, Lawrence

29. AP: Feds Tested AIDS Drugs on Foster Kids 
AP via Yahoo! News - May 05 9:00 AM
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.

30. What some states do involving foster kids in AIDS drug studies 
Belleville News-Democrat - May 04 11:39 AM
What researchers, state officials and foster care agencies in various states told The Associated Press about the use of foster children in AIDS drug experiments.

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