- 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
- 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
- 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
- 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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