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Friday, January 05, 2007

Paxil’s Ghost - More GSK corruption!

Paxil’s Ghost

BY CARL ELLIOTT

When the FDA’s Psychopharmacologic Drugs Advisory Committee holds its public hearing on December 13 to consider yet again the possible links between suicidality and the SSRI/SNRI antidepressants, one distinguished member of the advisory committee will be Dr. Bruce Pollock. Pollock used to be on the faculty at the University of Pittsburgh, but last year he was appointed to the Sandra A. Rotman Chair in Neuropsychiatry and Head of the Division of Geriatric Psychiatry at the University of Toronto. Pollock is also one of three committee members with extensive financial ties to antidepressant manufacturers. Pollock will not be allowed to vote, but his expertise was deemed so important by the FDA that his conflicts of interests were waived so that he could be included on the committee.

Pollock’s name may be familiar to scandal watchers. Two years ago, Congress was holding hearings on the question of whether GlaxoSmithKline had suppressed studies unfavorable to Paxil, and the New York attorney general had charged GlaxoSmithKline with consumer fraud. (GlaxoSmithKline settled the lawsuit without admitting wrongdoing, but paid a $2.5 million fine.) In December 2004, ABC News aired an investigative report on GlaxoSmithKline titled “Drug Maker Withheld Paxil Study Data: ABC News Uncovers Documents Unknown to Regulators and Many Study Doctors.” One of those documents concerned Pollock’s work for GlaxoSmithKline.

In the late 1990s, worries had emerged that patients might become dependent on the SSRIs. To combat the perception that people who stopped using Paxil might experience withdrawal symptoms – or “discontinuation” symptoms, as they were often called – GlaxoSmithKline (then still known as SmithKline Beecham) hired a public relations agency called Ruder Finn. Ruder Finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that Paxil was associated with discontinuation symptoms. According to internal memos, Pollock was one of four psychiatrists whom they planned to invite to “author” the letters.

A letter from Pollock eventually appeared in the Journal of Clinical Psychiatry. Although the wording of Pollock’s letter was somewhat different from the draft written by Ruder Finn, it made all the same points. It even made them in the same order. But there was no disclosure, no mention of industry funding, no mention of “editorial assistance,” and no mention of Ruder Finn. Pollock concluded his letter by saying, “Rather than directing our efforts towards the relatively infrequent, minor and transient discontinuation symptoms associated with SSRI therapy, clinicians may be well advised to focus their energies on the greater issues of efficacy, safety, and patient outcome.” The bottom line: concerns about discontinuation symptoms were overblown

Pollock was on the GlaxoSmithKline advisory board at the time, but he told ABC News that he had written the letter to the Journal of Clinical Psychiatry himself and had no knowledge of the draft letter prepared by the PR firm with his name on it. He did admit, however, that "could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?'" According to ABC News, Pollock’s letter later appeared in an internal business plan guide prepared for GlaxoSmithKline sales reps. It cited Pollock's letter as "an effective tool for addressing discontinuation."

Writing about the Paxil fraud case last year in the Hastings Center Report, Leemon McHenry described today’s pharmaceutical company marketing strategy as “defending the molecule.” Rather than drawing conclusions from the evidence, wrote McHenry, the strategy is to select the data that promote the drugs, ignore the unfavorable data, pay a prominent academic to sign onto ghostwritten articles about the positive data, and publish the ghostwritten article in the best journals. Then you complete the circle by citing the ghostwritten articles in your marketing literature.

Actually, McHenry left out one crucial part of the circle. If you are the person who signs the ghosted article, you just may get a seat on an FDA advisory committee and a named chair at the University of Toronto.

Copies of Ruder Finn's letters can be found here:

PDF RUDER FINN (right click and save as)

PDF DR POLLOCK'S WAIVER BY THE FDA (right click and save as)

PDF DR POLLOCK'S CONFLICT OF INTERESTS (right click and save as)
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