A drug company hid data that discovered its antidepressant didn't work and increased the risk of suicide in adolescents and teenagers. Instead, GlaxoSmithKline (GSK) hired a marketing team to prepare a 'scientific' paper that stated its drug Seroxat (paroxetine) was effective and safe-so putting at risk the lives of hundreds of thousands of young people.
An independent research team has discovered tens of thousands of pages of data that were discarded by the drug company for its Study 329 published in 2001, which concluded that paroxetine (also marketed as Paxil and Aropax) was "generally well tolerated and effective". The study was written by none of the original researchers, but by a marketing team, and it was headed up by Martin Keller, head of psychiatry at Brown University, who had financial ties to drug companies.
On the basis of the false study, GSK launched a major marketing campaign that proclaimed Seroxat's "remarkable efficacy and safety". Within a year, more than two million prescriptions had been written for children and adolescents across the US.
But rumours of Study 329's lost data were starting to emerge, and, in 2012, GSK faced criminal charges of fraud and was fined a record $3bn by the US's Department of Justice.
Now researchers from the University of Adelaide have found the hidden cache of data, which included evidence that 11 patients taking part in the trial had attempted suicide or had self-harmed. In addition, the drug was no more effective than a placebo, or sugar pill.
(Source: BMJ, 2015; 351: h4320)