Glaxo braves fire over HIV drug trials in orphans

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GlaxoSmithKline on Tuesday defended trials of HIV drugs in orphans, saying “clinical trials involving children and orphans were legal and not unusual.”

A BBC television documentary, “Guinea Pig Kids,” being shown later today, revives criticism of company-sponsored studies at the Incarnation Children’s Centre, a New York care home that specialises in treating HIV.

A report in the Observer newspaper in April first highlighted the “scandal” of deprived HIV-positive children, including blacks and Hispanics, being enrolled in drug trials.

It said the city’s health department had launched an investigation into claims that more than 100 children at Incarnation were used in 36 trials—at least four co-sponsored by Glaxo.

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

He quoted media reports saying that in some cases children were removed from foster homes when foster parents refused to give children the drugs.

Glaxo said regulatory agencies encouraged companies to conduct pediatric trials so that drugs can be appropriately prescribed to children. “Clinical trials involving children and orphans are therefore legal and not unusual.”

The company said 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.

“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,” the company added in a statement.

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