UK firm tried HIV drug on orphans

[Guest guest]

Hi Patty;;

 

Very sad indeed.

 

Louise

 

UK firm tried HIV drug on orphans

 

GlaxoSmithKline embroiled in scandal in which babies and children were

allegedly used as 'laboratory animals'

 

Antony Barnett in New York

Sunday April 4, 2004

The Observer

 

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.'