GlaxoSmithKline is being investigated by the U.S. Department of Justice for its research and marketing of Paxil in both adults and children, according to the Wall Street Journal. US investigators are particularly interested in what Glaxo knew about the suicidal risks of Paxil when it sought approval for the drug with the FDA and when it promoted the drug for off-label use in children and adolescents.
The federal investigators were particularly interested in the Paxil clinical trial known as study 329, which is the focus of my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. As Side Effects reveals, the authors of study 329 concluded that Paxil was safe and effective in adolescents, even though the actual data in the study showed the opposite. This particular study has come under fire from other independent medical researchers as well; see my previous blog Drug company under fire for Paxil research. Sen. Charles Grassley (R-Iowa) has also demanded an investigation of Paxil’s approval by the FDA.
Even as this controversy gains momentum, the drug industry is not standing idly by. Allan Lundy, a psychologist who receives research funding from the industry and has done antidepressant trials for several drug companies, wrote a largely negative review of my book – no surprise there. What is surprising is that a once respected newspaper, The Philadelphia Inquirer, published the review without questioning Lundy’s partiality. I guess this is what happens when economically squeezed newspapers cut their own book review staff and don’t vet freelancers' credentials.