FDA is challenging Wyeth's Effexor (venlafaxine) promotions on the grounds that they imply that the antidepressant is more effective than SSRIs.

The ¹ promotional materials, which include a case study mailer, a journal advertisement and reprint carrier, claim that the serotonin and norepinephrine reuptake inhibitor is a more effective antidepressant than selective serotonin reuptake inhibitors, a March 18 FDA ad division letter states.

"This has not been demonstrated by substantial evidence or substantial clinical experience," the letter says. "The meta-analysis cited in the materials is not sufficient to support this claim."

Wyeth cited a study published in the British Journal of Psychiatry, but FDA said that the data are not powerful enough for the company to claim superiority over SSRIs.

"The meta-analysis is essentially a comparison of venlafaxine to fluoxetine [Lilly's SSRI Prozac ]. It, therefore, fails to support the claim that Effexor XR is superior to all SSRIs," ² the ad division's letter states.

FDA also notes that the results of the study are potentially biased. "It is possible that any advantage observed for venlafaxine was driven by a subgroup of patients who had previously failed trials of SSRIs. This limitation was noted by the authors of the meta-analysis, and is widely recognized."

The letter also states that the results of the meta-analysis did not reach a level of statistical significance sufficient for the company to make its superiority claim. "To be significant, the results must be of a greater statistical power, which was not met," the letter states.

The FDA action reinforces the agency's position that advertisements that contain promotional materials in addition to a journal article - rather than simply the distribution of a journal article by itself - falls under the agency's jurisdiction.

The ad division letter also cites Wyeth's use of a separate radio promotion for making misleading claims. FDA asserts that the company "failed to communicate important characteristics necessary to distinguish between major depressive disorder and variations of normal daily functioning."

"By failing to draw a clear distinction between depressive disorder and normal periodic feelings of low interest or low energy, the advertisement broadens the indication for Effexor XR," FDA said.

The FDA letter follows an investigation by the U.S. Office of Personnel Management's Inspector General into the promotion of Effexor to physicians and pharmacists as part of a broader inquiry into the promotional practices for mental health products (³ Also see "Effexor Latest Target Of U.S. Office Of Personnel Management Investigation Into Rx Marketing" - Pink Sheet, 30 January, 2004.).

- Lee Kalowski

Wyeth Effexor Promotions Cited For Superiority Claims In FDA Letter

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