Tuesday, May 05, 2009

BMS - Abilify: marketing blues

A 38-state coalition has launched an investigation into Bristol-Myers Squibb for alleged violations of state consumer protection laws with regard to the marketing of the atypical antipsychotic Abilify (aripiprazole), which is marketed by BMS/Otsuka.

Elsewhere, the clinical trials cited as evidence of Abilify's power to vanquish depression have been met with skepticism. In the most-cited company-funded study, published in the April 2008 Journal of Psychopharmacology, researchers found that among depressed subjects who supplemented their antidepressant with Abilify, rather than with a placebo, 25.4% reported some relief of their symptoms. Among those taking a dummy pill with their antidepressant, 15.2% reported some improvement in their mental health.

Critics complained that Bristol-Myers Squibb's researchers set a low bar for "remission" and that their study design gave aripiprazole (Abilify) every advantagein the comparison. Even so, the difference between subjects who took Abilify over those who did not, at just over 10 percentage points, was pretty modest, they said. "The results are extremely unimpressive; they just squeak by," says Massachusetts psychiatrist Daniel Carlat, editor of the respected Carlat Psychiatry Report. For a clinician or a patient's family, the difference between those on Abilify and those who took a placebo "would be hard to actually see," he adds.

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