UK firm tried HIV drug on orphans

GlaxoSmithKline embroiled in scandal in which babies and children were allegedly
used as 'laboratory animals' The trials were run by Columbia University Medical
Centre doctors.

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 lengtened 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.'

http://www.guardian.co.uk/aids/story/0,7369,1185358,00.html