In a highly unusual intervention, the US Justice Department has told District Judge Mariana Pfaelzer to reverse her order to GlaxoSmithKline to drop TV advertising claims that its antidepressant drug Paxil is “non-habit forming”.
The ban, due to come into force on August 30, is “contrary to federal law” and “inconsistent [with the] scientific and carefully considered view” of the US Food and Drug Administration, admonished the Justice Department, adding that the FDA had reviewed the Paxil commercials and raised no objection.
Los Angeles-based Judge Pfaelzer made her controversial decision during 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”.
Says attorney for the plaintiffs Karen Barth: “Within a few days, they started getting extraordinarily sick, throwing up every hour on the hour for two months.” They also suffered “electric zaps”, she alleged. “It's as if you were to be charged with electricity through your brain.”
But these, insisted Andy Bayman, an Atlanta lawyer representing Glaxo, were emphatically not ‘withdrawal symptoms’. That term, opined the attorney, is too closely associated by the public with heroin and other addictive narcotics in which “you continue to crave the drug and you take radical steps to get the drug.”
As is the way with lawyers representing multinational pharmaceutical clients, Bayman did not draw the attention either of the court or the Justice Department to a report from Britain's Royal College of Psychiatrists.
This 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 [the drug’s European branding].
Data sourced from: The Wall Street Journal Online; additional content by WARC staff