Tuesday, June 9, 2009

Abilify/aripiprazole: Akathisia-gate

It must be beyond anyone’s imagination that Richard Nixon’s Watergate scandal has added “gate” to whatever scandal that affects not just politicians as it has now moved to the medical world and it involves major pharmaceutical companies.
Getty Images

I was grateful for Carlat Psychiatry Blog for a series of articles on the matter of Abilify/aripiprazole and the ways Bristol-Myers Squibb tried to downplay one of its major side effects: akathisia-restlessness of all kinds to the sufferers.

From the Carlat Pscyhiatry Blog:
Akathisia-gate Scandal in Wall Street Journal
Thursday, May 14, 2009

"Akathisia-gate, Bristol-Myers Squibb's ongoing efforts to distract attention from the major side effect of its blockbuster antipsychotic drug Abilify, has expanded into a scandal that was covered on the front page of today's
Wall Street Journal."

"Staff writer Shirley Wang profiles Andy Behrman, a man with bipolar disorder who gained notoriety when he published the book Electroboy: A Memoir of Mania. According to the article, representatives of BMS approached Behrman after the book's publication and asked him to do promotional speeches for Abilify, which was about to gain FDA approval for the treatment of mania. He initially signed a contract for $40,000, and eventually made up to $10,000/day.The problem is, soon after he started taking Abilify, Behrman noticed restless sensations in his legs--akathisia. He said he told his BMS handlers about the side effect, which the company denies. At any rate, apparently the money he was receiving was just too good for him to tell the truth about his side effects, and he continued providing glowing endorsements. He said that the company provided him with talking points, and instructed him to reiterate in his talks that Abilify had no side effects and to avoid mentioning that he was being paid by BMS."

"Of course, the company denies any malfeasance, claiming that Behrman requested an exhorbitant $7.5 million for further talks, and that the company refused the offer. The implication is that Behrman is simply a disgruntled former hired gun. We may never know the entire truth of the matter. But knowing the sordid history of pharmaceutical marketing tactics, I'm giving Behrman the benefit of the doubt here."

Abilify and the Great Akathisia Cover-up, Part 2
Tuesday, May 12, 2009
He quoted a CME presentation:

"Adverse event dropouts; you always want to know, How well were these drugs tolerated? And in this first study it was pretty darned good. I mean, it looked very placebo-like in terms of ability to stay on the drug. The data for both studies when they’re put together in the package insert have a dropout rate of about 6% for aripiprazole. So it’s a bit higher than placebo. A lot of restlessness, a lot of akathisia, you know, people sort of a little bit unable to sort of stay still, but they could tolerate the drug. That’s 23%, 25% in the package insert. So some side effects, but overall pretty good tolerability."

I remember many of those at The American Psychiatric Association Conferences in major hotels in Chicago or New Orleans. Perhaps not anymore?

Other Posts to read:
Abilify, the Journal of Clinical Psychiatry, and "Akathisia-gate"
The Journal of Abilify Psychiatry: A CME Activity

No comments: