A National Scandal: AIDS Drug Experiments on Foster Care Children_Assoc Press

[Guest guest]

Thu, 5 May 2005 18:01:42 +0200

" Sepp Hasslberger " <sepp

 

 

Fwd: A National Scandal: AIDS Drug Experiments on Foster Care

Children_Assoc Press

 

I am passing this on for your information - experiments with AIDS

drugs on children are being investigated...

 

Kind regards

Sepp

 

 

 

>ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

>Promoting Openness, Full Disclosure, and Accountability

>www.ahrp.org

>

>FYI

>

>On March 10, 2004, The Alliance for Human Research Protection filed a

>complaint with the FDA and the federal Office of Human Research

Protection

>about a series of AIDS drug experiments conducted on New York City

children

>in foster care. That complaint prompted two separate investigations

by the

>FDA and OHRP which are still on-going.

>

>Articles in The New York Post and a documentary by BBC raised the

alarm

>among the African-American and Latino community in NY-some of who have

been

>protesting weekly in front of Incarnation Children's Center, the site

of

>some of the drug experiments.

>

>The Associated Press AP has just released its investigative report:

the

>problem is a national scandal--the experiments were conducted in " at

least

>seven states -- Illinois, Louisiana, Maryland, New York, North

Carolina,

>Colorado and Texas -- and involved more than four dozen different

studies.

>

>AP's investigation found that 13,878 children had been enrolled in

pediatric

>AIDS studies funded by the government since the late 1980s. Of these,

>officials estimated that 5 percent to 10 percent were in foster care.

Their

>age ranged from infants to late teens.

>

> " More than two dozen Illinois foster children remain in studies

today. "

>

>Those who conducted the experiments in violation of federal

regulations, are

>supported by taxpayers-thus they have a public responsibility which

they

>violated. The children who were targeted to serve as human drug

testing

>subjects-mostly poor children of color-were not afforded the

protection of a

>personal advocate-as is mandated by federal regulations. (45 Code of

>Federal Regulations 46.409)

>

>The institutional culture of arrogance is demonstrably in evidence at

both

>medical research centers and government agencies:

> " Our position is that advocates weren't needed, " said Marilyn

Castaldi,

>spokeswoman for Columbia Presbyterian Medical Center in New York.

>

>And officials of NYC Administration of Child Services " 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. "

>

>The children are reported to have suffered painful 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 testing the drug dapsone, " 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. "

>

> " 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.

>

>At least three states declined to use children in foster care 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.

>

>Not addressed in the AP report is the amount of money that these

trials

>generated for the institutions involved in the experiments.

>

>***The NYC Council, general welfare committee is holding a hearing

about the

>unethical experiments conducted in NYC. The hearing will take place at

City

>Hall at 11:15.

>For information and to register to speak, call: Ms. Jackie Sherman at

>212-788-7015

>

>

>Contact: Vera Hassner Sharav

>212-595-8974

>veracare

>

>

>http://www.latimes.com/news/nationworld/wire/ats-ap_top13may04,0,7330019.sto

>ry

>Researchers Tested AIDS Drugs on Children

>By JOHN SOLOMON

>Associated Press Writer

>

>11:08 AM PDT, May 4, 2005

>

>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.

>

>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.

>

>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.

>

>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.

>

>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.

>

>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.

>

>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.

>

>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. "

>

>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. "

>

>* __

>

>Researcher Rachel Landau in Washington and reporter Carla K. Johnson

in

>Chicago contributed to this story. On the Net:

>

>Documents associated with this story are available at:

>

>http://wid.ap.org/inv/foster.html

>

>National Institutes of Health: http://www.nih.gov

>

>

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--

 

 

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