Pfizer Faces Criminal Charges in Nigeria

from: The Washington Post

By Joe Stephens
Washington Post Staff Writer
Wednesday, May 30, 2007; A10

Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic.

Authorities in Kano, the country's largest state, filed eight charges this month related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer, the world's largest drug company.

The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges. It also represents the latest in a string of public-relations blows stemming from the decade-old clinical trial, in which Pfizer says it acted ethically.

The government alleges that Pfizer researchers selected 200 children and infants from crowds at a makeshift epidemic camp in Kano and gave about half of the group an untested antibiotic called Trovan. Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.

The lawsuit says that the researchers did not obtain consent from the children's families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use." Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria.

Pfizer and its doctors "agreed to do an illegal act," the criminal charges state, and behaved "in a manner so rash and negligent as to endanger human life."

Internal Pfizer records obtained by The Washington Post show that five children died after being treated with the experimental antibiotic, though there is no indication in the documents that the drug was responsible for the deaths. Six children died while taking the comparison drug.

Suspicion stirred by news of the drug trial has been so intense in Kano, the lawsuit says, that parents last year refused to allow their children to be immunized against polio, frustrating a program aimed at wiping out one of the disease's last refuges.

In a statement, Pfizer said it thinks it did nothing wrong and emphasized that children with meningitis have a high fatality rate.

"It is indeed regrettable that, more than a decade after the meningitis epidemic in Kano, the Nigerian government has taken legal action against Pfizer and others for an effort that provided significant benefit to some of Nigeria's youngest citizens," the statement said.

"Pfizer continues to emphasize -- in the strongest terms -- that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company's abiding commitment to patient safety. Any allegations in these lawsuits to the contrary are simply untrue -- they weren't valid when they were first raised years ago and they're not valid today."

The criminal charges also name Pfizer's Nigerian subsidiary and eight current or former executives and researchers. The charges could result in fines and prison sentences ranging from six months to seven years per count, according to Aliyu Umar, who served as Kano attorney general until earlier this month.

Umar said he filed the charges with the backing of federal and state authorities. He said it took 11 years to bring the action because officials only learned details in recent years, through a series of investigative reports in The Post. Three months ago, Umar's office obtained a six-year-old Nigerian government report that concluded Pfizer's actions violated international law.

"We realize we are the Third World and we need assistance," Umar said. "But we frown on people who think they can take advantage of us, especially if it's for profit. That's why we decided we needed to take action against Pfizer.

"Those people responsible should be punished, whether in Nigeria or in the United States, for what they did to our people."

Pfizer's drug trial came to public attention in December 2000, when The Post published the results of a year-long investigation into pharmaceutical testing in the developing world. Nigerians met the news with street demonstrations and demands for reform.

Nigeria's health minister appointed a panel of experts to look into Pfizer's actions, but its final report was suppressed without explanation. Last year, The Post obtained a copy, which revealed that the panel had concluded Pfizer's actions violated Nigerian law, the international Declaration of Helsinki and the U.N. Convention on the Rights of the Child.

The panel said Pfizer administered an oral form of Trovan that apparently had never been given to children with meningitis. It said there were no records documenting that Pfizer told the children or their parents that they were part of a drug trial. And it said an approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions, was a sham concocted long after the trial ended.

"The families of the children who [Pfizer] used as laboratory guinea pigs were led to believe and in fact understood that the Defendants were providing their children with volunteer relief, clearly focused humanitarian medical intervention and nothing more," the lawsuit says.

Parents were not told that alternative treatments were available, it adds.

The suit charges that parents were barred from Pfizer's ward and that the company's own lab tests had shown Trovan's life-threatening side effects. Researchers allegedly administered the comparison drug, Rocephin, in dangerously low doses to make Trovan look more effective.

The lawsuit contends that Pfizer researchers left the area during the epidemic, took all medical records and "obliterated any evidence" of the trial.

"Defendant's illegal conduct was deliberate and solely motivated by financial considerations," it says.

Every surviving child suffered one or more disabilities, the lawsuit says, adding that the state of Kano has incurred major costs caring for the children and otherwise dealing with the drug trial 's repercussions.

In its statement, Pfizer said the drug was in late-stage development and had been tested on 5,000 patients in a number of countries. "Pfizer's doctors had solid scientific evidence that it would provide a safe and effective treatment against the deadly disease," the statement said. The treatment "indisputably helped save the lives of almost 200 children," the company said.

The U.S. Food and Drug Administration never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to restrict its use in 1999. It remains available in the United States, but European regulators have banned it.

Research editor Alice Crites contributed to this report.

0

In the hands of strangers

Just one of the examples of what can happen when children are handed over to a more powerful party than the child's own family.

Poor Bastards

Did the company think/hope these families were dumber than dirt?

'taken away children' easy guinea pigs?

Testing AIDS drugs on hundreds of foster children

Humanist,  July-August, 2005  by Karen Ann Gajewski

* The Associated Press reported in May that "federally funded researchers have been testing AIDS drugs on hundreds of foster children since the late 1980s, often without providing independent advocates to safeguard the children's interests." The Bush administration believes drug testing on children is "essential" to the development of critical medicines and, as standards for enlisting foster children in federal medical experiments vary widely from state to state, wants to streamline standards. The Association for the Accreditation of Human Research Protections Programs points out, however, that such testing presents special ethical dilemmas--particularly given past medical research history. Several states, including Wisconsin, have declined to use foster children for medical experiments.

 

MORE Medical testing????

Does this mean children are being used without the REQUIRED parental consent for medical testing?

Isn't it bad enough children are being medicated with anti-psychotic drugs because they miss their mommy and daddy?

How can this keep happening?

 

More on AIDS Drug experiments on Foster Care Children

A National Scandal: AIDS Drug Experiments on Foster Care Children - Assoc Press

Wed, 04 May 2005

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

Researchers Tested AIDS Drugs on Children

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

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

and...

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.

“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.

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.”

© 2005 The Associated Press. All rights reserved.

we need a radical stand against this practice

it looks like profit and pills come before repairing broken families

people need to come first

before more children get hurt

needles and AIDS stack

strangers and rapisits attack

which comes first

amendments or bloody constitution?

don't make me sick!

it's a medical witch-hunt

and a government trick

Pound Pup Legacy