Misrepresenting Abilify

There was an Associated Press story the other day on how there's bright news on the atypicals front for drug makers (yes, but what about for the patients?). At the end, the AP business reporter noted that Bristol Myers-Squibb had just announced study results that "its antipsychotic drug, Abilify, delayed relapses in adults with Bipolar I Disorder for up to two years."

Interesting, I thought, and did some poking around, because that struck me as a lipstick-on-a-pig statement. Sure enough from a company press release:

"Of the 161 adults who entered the trial, 67 completed the 26-week phase (ABILIFY n=39, placebo n=28). Sixty-six adults entered the 74-week phase (ABILIFY n=39, placebo n=27). Of these adults, 30 discontinued due to various reasons (ABILIFY n=18, placebo n=12), 24 discontinued prematurely due to study termination (ABILIFY n=14, placebo n=10), and 12 completed the additional 74 weeks of treatment (ABILIFY n=7, placebo n=5). Such drop-out rates are common in long-term studies of people with Bipolar I Disorder."

OK, so BMS is making this claim about Abilify based on results in 7 patients:

"Maintenance therapy with ABILIFY for nearly two years significantly delayed time to relapse in adults with Bipolar I Disorder who had a recent manic or mixed episode and were then stabilized with the medication for at least six weeks, according to findings published in a supplement to Neuropsychopharmacology."

Color me completely unconvinced. It embarrasses me when so many reporters buy the sizzle and don't really bother to look at the mechanics of these studies. There'd be much less hype of Pharma's products if that were the case. And, shit, even harried wire services business reporters have time to figure it out. BTW, Reuters, Street Insider and MSN Money all went with the same spin. Sigh.

I cannot locate that supplement to the journal, so for now, no link to it from me.

Posted by Philip Dawdy at December 11, 2006 12:03 AM
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