The drug company admitted it had promoted unproven use of an antidepressant, sold as Aropax here and Paxil overseas, for children, and did not disclose research linking it to suicidal thoughts.
Australian researchers played a key role in exposing the illegal marketing of the drug, revealing significant flaws in a research paper used to promote it.
Aropex ... fraudulently promoted for the treatment of diabetes and mental illness. The head of the department of psychological medicine at the Adelaide Women's and Children's Hospital, Jon Jureidini, said it was distressing that even such record fines were a ''necessary cost of doing business''.
He and researcher Anne Tonkin outlined the ''distorted and unbalanced'' interpretation of the results of a study of Aropax use in children, published in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry.
They argued the research did not show Aropax was safe and effective for depression in young people, and repeatedly asked for the paper to be withdrawn. He later worked with Australian Peter Mansfield and a bioethicist currently working in the US, Leemon McHenry, to expose the selective use of evidence in the paper revealed by internal drug company documents.
As part of the settlement GlaxoSmithKline agreed to the US prosecutor's argument that the study was "false and misleading", and had been prepared by a ghostwriter. Despite this, the journal has not retracted the article.
Professor Jureidini said while there was no evidence the company undertook the same aggressive and illegal promotion of the drug to doctors here as they did in the US, the research likely influenced prescribing.
"Thousands of children and adolescents who should not have been put on antidepressants were put on antidepressants, and we can be reasonably confident that a small but significant number of them will have been badly harmed," he said.
