US Judge Upholds GSK Drug’s ‘Non-Habit-Forming’ TV Claim

15 October 2002

Anglo-American pharmaceuticals colossus GlaxoSmithKline has won its legal battle against the recent ruling by Los Angeles District Judge Mariana Pfaelzer ordering GSK to drop TV advertising claims that its antidepressant drug Paxil is “non-habit forming”.

Judge Pfaelzer made her controversial decision whilst hearing a lawsuit filed by thirty-five people who allege they suffered debilitating withdrawal symptoms after coming off the nostrum which last year notched $2.67 billion in sales. She noted that “labeling in other countries warns of adverse withdrawal reactions following discontinuation of Paxil”.

Her ruling, which activated the muscle of Big Pharma, was suspended within days in a highly unusual intervention by the US Justice Department. Judge Pfaelzer’s decision, opined the department, was “contrary to federal law” and “inconsistent [with the] scientific and carefully considered view” of the US Food and Drug Administration.

In reaching this view, both federal bodies chose to ignore the findings of a report by Britain’s respected Royal College of Psychiatrists, which noted: “As many as one-third of people experience withdrawal symptoms for a short time when they stop taking antidepressants. The symptoms range from vivid dreams and dizziness to anxiety and sensations in the body that feel like electric shocks and “seem to be most likely to happen” with Seroxat [Paxil’s European branding].

But this expert opinion cut no ice with an unnamed US federal judge in California who ruled late Thursday that GSK should be allowed to resume its “non-habit-forming” claim in US television advertisements.

Nor, seemingly, was the judge aware of [or perhaps chose to ignore] a highly critical TV documentary aired Sunday in the UK. Panorama, the BBC’s respected weekly documentary program, alleged that Paxil’s withdrawal symptoms can lead some patients to harm themselves, even commit suicide.

GlaxoSmithKline's shares rose 4% in afternoon trading in London Friday.

Data sourced from: The Wall Street Journal Online; additional content by WARC staff