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| ABC News |
| Drug firm defends trials on children in care |
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| 01 December 2004 |
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| GlaxoSmithKline has defended trials of AIDS/HIV drugs in children in care homes, saying clinical studies involving children are legal and not unusual. |
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| A BBC television documentary entitled Guinea Pig Kids revives criticism of company-sponsored studies at the Incarnation Children's Centre, a New York care home that specialises in treating HIV. |
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British newspapers have previously highlighted how deprived HIV-positive children have been enrolled in drug tests.
Michael Weinstein, president of the AIDS Healthcare Foundation, says that the company is "being accused of exploiting one of our most vulnerable populations".
GlaxoSmithKline, the world's largest maker of AIDS/HIV medicines, responds that regulatory agencies encourage companies to conduct paediatric trials so that medicines could be appropriately prescribed to children.
"Clinical trials involving children and orphans are therefore legal and not unusual," it said.
The company adds that it has provided drugs for four trials conducted by the Pediatric AIDS Clinical Trials Group (PACTG) and funds and drugs for a fifth paediatric trial involving Columbia Medical Centre.
"The PACTG designs and implements the studies," he said.
"Companies like [GlaxoSmithKline] will choose to provide medicine, funding, or not participate, based on a review of the trial design - but ultimate approval, control and execution of the study are the responsibility of the PACTG.
"This is appropriate, as long as such trials are conducted under the most stringent standards, and in compliance with the various state and federal laws and regulations regarding legal authority in the case of minors." |
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| Source: ABC News |
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