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.'
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