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Young Children and Babies Used as Lab Rats in Drug Trials

London Observer| April 4 2004

Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.

British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.

The children had either been infected with HIV or born to HIV-positive mothers. Their parents were dead, untraceable or deemed unfit to look after them.

According to documents obtained by The Observer, Glaxo has sponsored at least four medical trials since 1995 using Hispanic and black children at Incarnation. The documents give details of all clinical trials in the US and reveal the experiments sponsored by Glaxo were designed to test the 'safety and tolerance' of Aids medications, some of which have potentially dangerous side effects. Glaxo manufactures a number of drugs designed to treat HIV, including AZT.

Normally trials on children would require parental consent but, as the infants are in care, New York's authorities hold that role.

The city health department has launched an investigation into claims that more than 100 children at Incarnation were used in 36 experiments - at least four co-sponsored by Glaxo. Some of these trials were designed to test the 'toxicity' of Aids medications. One involved giving children as young as four a high-dosage cocktail of seven drugs at one time. Another looked at the reaction in six-month-old babies to a double dose of measles vaccine.

Most experiments were funded by federal agencies like the National Institute of Allergy and Infectious Diseases. Until now Glaxo's role had not emerged.

In 1997 an experiment co-sponsored by Glaxo used children from Incarnation to 'obtain tolerance, safety and pharmacokinetic' data for Herpes drugs. In a more recent experiment, the children were used to test AZT. A third experiment sponsored by Glaxo and US drug firm Pfizer investigated the 'long-term safety' of anti-bacterial drugs on three-month-old babies.

The medical establishment has defended the trials arguing they enabled these children to obtain state-of-the-art therapy they would otherwise not have received for potentially fatal illnesses.

However, health campaigners argue there is a difference between providing the latest drugs and experimentation. They claim many of the experiments were 'phase 1 trials' - among the most risky - and that HIV tests for babies were not a reliable indicator of actual infection and therefore toxic drugs could have been given to healthy infants. HIV drugs are similar to those used in chemotherapy and can have serious side-effects.

Vera Sharav, president of the Alliance for Human Research Protection, said the children had been treated like 'laboratory animals'.

'These are some of the most vulnerable individuals in the country and there appears to be a policy of giving drug firms access to them,' she said. 'Throughout the history of medical research we have seen prisoners abused, the mentally ill abused and now poor kids in a care home.'

Sharav has urged the US Food and Drug Administration to investigate and has demanded full disclosure of all adverse effects suffered by the children, including deaths. Brooklyn Democrat councillor Bill de Blasio is also demanding that New York's Administration for Children's Services, which approved the trials, reveal who gave consent and on what grounds.

Glaxo has confirmed it provided funds for some of the experiments but denied any improper action. A spokeswoman said: 'These studies were implemented by the US Aids Clinical Trial Group, a clinical research network paid for by the National Institutes of Health. Glaxo's involvement in such studies would have been to provide study drugs or funding but we would have no interactions with the patients.

'Generally speaking, clinical research is carefully regulated in the US and it would be the responsibility of the appropriate authorities to ensure all subjects in a clinical trial provided appropriate, informed consent to conform with all local laws and regulations regarding legal authority in the case of minors.'

The Incarnation trials were run by Columbia University Medical Centre doctors. Columbia spokeswoman Annie Bayne said there had been no clinical trials at Incarnation since 2000 and that consent for the children was provided by the Administration for Children's Services, which uses a panel of doctors and lawyers to determine whether the benefits of a trial for each child outweighs the risks. 'There are many safeguards in the system. HIV is eventually a fatal disease, but drug therapy has lengthened life significantly,' said Bayne.

A spokesman for Incarnation said: 'The purpose of the trials was to test the efficacy of HIV medication ... These trials were based on scientific evidence of their potential value in the treatment of HIV-infected children.'


Flashback:

 

 

AIDS TOTS USED AS 'GUINEA PIGS'

NY Post
February 29, 2004

The state Health Department has launched a probe into potentially dangerous drug research conducted on HIV-infected infants and children at a Manhattan foster-care agency, The Post has learned.

Some 50 foster kids were used as "guinea pigs" in 13 experiments with high doses of AIDS medications at Manhattan's Incarnation Children's Center, sources said.

Most of the ICC experiments were funded by federal grants and in some cases, pharmaceutical companies. They used city foster children, who were sent to the Catholic Archdiocese-run facility by the Administration for Children's Services.

ICC was involved in 36 different experiments, according to the National Institutes of Health Web site. One study researched "HIV Wasting Syndrome," which studied how a child's body changes when his medication is altered.

A handful of the experiments involved combining up to six AIDS drugs - so-called "cocktails" - in children as young as 3 months, and another explores the reaction of not one, but two doses of the measles vaccine in kids ages 6 to 7 months.

Other studies tested the "safety," "tolerance" and "toxicity" of AIDS drugs.

"They are torturing these kids, and it is nothing short of murder," said Michael Ellner, a minister and president of Health Education AIDS Liaison, an advocacy group for HIV parents.

Biochemist Dr. David Rasnick, a visiting scholar at the University of California at Berkeley and an expert in AIDS medication, was outraged because the drugs, alone or combined, have "acute toxicity which could be fatal."

He said the drugs' side effects include severe liver damage, cancerous tumors, severe anemia, muscle wasting, severe and life-threatening rashes and "buffalo hump," where fatty tissues accumulate behind the neck.

Housed in a former convent and run by the Archdiocese of New York's Catholic Charities, the foster-care agency described the experiments on its own Web site, which was abruptly shut down after The Post began making inquiries.

Archdiocese spokesman Joseph Zwilling said experiments at ICC were halted in 2002. He said he did not know why. Zwil- ling also said he did not know if any children had died.

An ACS spokeswoman said the agency hasn't approved any new experiments since 2000 because the "risks outweighed the benefits." She declined to explain further. That agency is also reviewing its files on the case.

Jacqueline Hoerger was a pediatric nurse at ICC from 1989 to 1993 and said the experimentation was going on even back then. "We were taught that any symptom we saw was HIV-related," said Hoerger, 43. "The vomiting, diarrhea, wasting syndrome, the neurological side effects - they were dying. There was death."

She didn't think doctors were doing anything wrong, however, until years later, when she tried to adopt two of the foster girls. When she refused to give the kids the center's high-powered AIDS cocktails for fear it was making them sicker, ACS had social workers take the children away from her.

Advocates for children question the ethics of experimenting on foster kids - especially those too young to know what's happening to them.

"The most vulnerable, disadvantaged children are being exploited by powerful entities and used as guinea pigs as if they were not human beings," said Vera Sharav from the Alliance for Human Research and Protection.

The tests were conducted by doctors from Columbia Presbyterian Medical Center, which was affiliated with ICC until 2002 and reaped the financial benefits of the research.

"Through these trials, children at the ICC outpatient clinic gained access to state-of-the-art treatments for HIV," said Annie Bayne, a Columbia spokeswoman.

ACS policy states it seeks parental consent before a child is enrolled in a study. If the parents cannot be found, ACS's medical and legal divisions, and its commissioner, must all approve.

The condition, however, is that the experiment "offer each participating child a significant potential benefit, a concomitant minimal risk of injury or harm," ACS spokeswoman MacLean Guthrie said.

Fire Commissioner Nicholas Scoppetta, who headed ACS at the time of the experiments, refused comment.

Officials at ICC, which was established in 1989 to house and care for HIV-infected "boarder babies" left stranded in city hospitals, refused to talk to The Post.

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