US District Judge Mariana Pfaelzer has bowed to the democratic will – or depending how you look at it, the muscle of the global pharmaceuticals industry – as she put on hold her order to Anglo-American drugs giant GlaxoSmithKline to pull and amend its TV ads for antidepressant drug Paxil [WAMN: 22-Aug-02].
Pfaelzer was last week admonished by the US Justice Department for imposing the ban, due to come into force on August 30. The public body deemed her decision “contrary to federal law” and “inconsistent [with the] scientific and carefully considered view” of the US Food and Drug Administration. The latter, said the Justice Department, had reviewed the Paxil commercials and raised no objection.
Pfaelzer's controversial order to pull the Paxil spots came after she ruled its commercials were “misleading and created inaccurate expectations about the ease of withdrawal from the drug”. Her decision was influenced by a civil lawsuit against GSK filed on behalf of 35 patients who claimed they suffered withdrawal symptoms such as nausea, fever, and “electric zaps” to their bodies.
This allegation tallies with the impartial opinion of Britain's 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].
GSK immediately appealed the decision, backed by an outraged FDA which claimed Judge Pfaelzer had “exceeded her authority” and impinged on its own. Blustered an FDA spokesperson: “This is not about a single product or a single company but about FDA’s authority over prescription drug advertising,.”
Judge Pfaelzer said the postponement from September 1 to September 12 “is intended to give [GSK and the FDA] time to respond in court.”
According to CMR, GSK via its agency McCann-Erickson, New York, spent $65 million (€66.72m; £42.67m) on Paxil advertising in the US in 2001, and $52 million in the first five months of 2002. Global sales of Paxil last year hit $2.67 billion and grew a further 29% during the second quarter.
Data sourced from: AdWeek.com; additional content by WARC staff