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Glaxo Defends Testing AIDS Drugs in Children

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LONDON (Reuters) - GlaxoSmithKline Plc Tuesday defended trials of AIDS/HIV drugs in children in care homes, saying clinical studies involving children were legal and not unusual.

A BBC television documentary entitled "Guinea Pig Kids," being shown later in the day, revives criticism of company-sponsored studies at the Incarnation Children's Center, a New York care home that specializes in treating HIV.
British newspapers have previously highlighted how deprived HIV-positive children were enrolled in drug tests.

Michael Weinstein, President of the AIDS Healthcare Foundation, a U.S. group often critical of GSK, said in a statement that the company was "being accused of exploiting one of our most vulnerable populations."

GSK, the world's largest maker of AIDS/HIV medicines, responded that regulatory agencies encouraged companies to conduct pediatric 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 added that it had provided drugs for four trials conducted by the Pediatric AIDS Clinical Trials Group (PACTG) and funds and drugs for a fifth pediatric trial involving Columbia Medical Center.

"The PACTG designs and implements the studies. Companies like GSK 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," the company said in a statement.

"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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