ORPHANS AND BABIES USED AS GUINEA PIGS ! !

British drug giant GlaxoSmithKline stands accused of using orphans and babies as young as three months old as guinea pigs in potentially dangerous medical experiments. Glaxo and other firms sponsored experiments on the children from Incarnation Children's Center. Licensed by the New York State Department of Social Services and the New York City Agency for Children's Services, the center was established in 1988 through the collaborative efforts of The Catholic Home Bureau (Archdiocese of New York), The Columbia University Department of Pediatrics, The Harlem Hospital Pediatric AIDS Program and the Samuel and May Rudin Foundation.

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

According to documents 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.

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. 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.

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.

A letter from the Alliance for Human Research Protection to the Dept. of Health and Human Services stated, "We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children's Services (ACS), and living at Incarnation Children's Center, a foster care facility under contract with ACS. The test subjects were children diagnosed with HIV infection - in some cases infants who were merely "presumed" to be HIV-infected. Phase I and Phase II experiments involve the greatest level of risk and discomfort for children insofar as they test the safety and toxicity of the drugs as well as maximum dose tolerance."

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 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.

The Incarnation trials were run by Columbia University Medical Center 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. Sources: Alliance for Human Research Protection, Guardian (UK), Observer (UK), Columbia University Medical Center.

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