GlaxoSmithKline ($GSK) has faced its fair share of scrutiny over a study of its antidepressant Paxil in teenagers, with some experts claiming that the company wrote off harmful side effects linked to the med. Now, a re-analysis of the original study suggests that the trial trumpeted Paxil's benefits while downplaying serious side effects including suicide.
In a new analysis published in the British Medical Journal, researchers looked at data from a 2001 study, dubbed Study 329, which found that Paxil improved "secondary" measures such as mood problems better than a placebo or an older depression drug, imipramine. GSK gave researchers permission to comb the company's files on the original study, providing access to summaries, internal trial reports and patient-level data, The New York Times reports.
Researchers found that out of 275 children and teens in the trial, 11 taking Paxil and one in the placebo group developed suicidal or self-harming behavior. The original publication of the study reported that 5 kids or teens on the drug and one on a placebo experienced those side effects, The Guardian reports.
"This is a very high rate of kids going on to become suicidal. It doesn't take expertise to find this. It takes extraordinary expertise to avoid finding it," David Healy, professor of psychiatry at Bangor University in Wales and a lead author on the re-analysis, told the Guardian.
The news delivers a blow to GSK, which has been traveling a bumpy road with Paxil since researchers started questioning Study 329. As the NYT points out, prescriptions of antidepressants to young people skyrocketed in the wake of that study, jumping 36% between 2002 and 2003. But in 2004, regulators slapped Paxil and other antidepressants with a black-box warning after serious side effects came to light. In 2011, GSK forked over $3 billion to settle an investigation by the U.S. government for falsely marketing Paxil. The company has also faced a raft of litigation over Paxil's links to suicidal behavior, which put Study 329 under legal scrutiny.
Perhaps unsurprisingly, Dr. Martin Keller, the leader of the original research on Study 329, and his co-authors are disputing the re-analysis, saying that they flagged secondary measures in the study before, not after, knowing which patients were taking Paxil and which were not. "In summary, to describe our trial as 'misreported' is pejorative and wrong," the researchers told the NYT in a joint statement.
And GSK is standing by its med, saying the increased risk of suicide in teens given antidepressants like Paxil "is widely known" and that "clear warnings have been in place on the product label for more than a decade," the company told the Guardian. "As such we don't believe this re-analysis affects patient safety."
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