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BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)

Jan 31, 2007 |

According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents suggesting that the company had conducted trials proving the drug was unsafe, but failed to accurately disclose that information. (Seroxat is a brand name for paroxetine, a selective serotonin reuptake inhibitor (SSRI) class of antidepressant marketed in the U.S. as Paxil.)

The BBC’s website reports: “GSK’s biggest clinical trial of Seroxat on children was held in the U.S. in the 1990s and called Study 329. Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329. In 2002, he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.”

The BBC program quotes U.S. attorney Karen Barth Menzies as saying, “They didn’t tell the regulators or the physicians or parents about these risks or the lack of efficacy; instead they went out and promoted this specific study as remarkably effective and safe for kids.”

The BBC’s Jofre later discovered that, after sending questions about the safety of Seroxat to Ryan in 2002, Ryan forwarded them to GSK asking for advice on how to respond. Jofre also found an email from a public-relations executive, saying, “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize.”

The Panorama investigation also found two other incriminating documents, one from GSK’s marketing department in 1999 that acknowledged the safety risks and another from 2001 that reiterated to its sales staff the safety and efficacy of the drug in treating adolescents even after the company was aware of the side effects.

“Even when they have negative studies that show that this drug Seroxat is going to harm some kids, they still spin that study as remarkably effective and safe for children,” added Menzies, a plaintiff attorney in a U.S. suit facing GSK over the drug.

Roughly 50,000 British children took the drug before it was banned in 2003 for use by patients under the age of 18. The documentary claims that GSK knew of the risks in the late 1990s.

In a statement responding to the BBC allegations, Glaxo says: “No suicides were reported in any of the nine pediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

“Only when all the data became available, at the end of the research program, and were analyzed together, was an increased rate of suicidal thinking or attempted suicide revealed in those pediatric patients taking Seroxat.”

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