Psychiatrists have continued to refer to the results of the trial despite these weaknesses, Tsai says. “Frankly, I think it’s an embarrassment to the profession that [Abilify] has been accepted so uncritically for this indication.”
Gregory E. Simon, MD, a psychiatrist at Group Health Research Institute, in Seattle, says that the perceived flaws noted in the review are not so clear-cut. “The methods of studying long-term effectiveness are complex, and experts disagree regarding the best ways to study this question,” he says.
Evidence for the long-term effectiveness of lithium is far stronger than that for newer medications, including Abilify, Simon says. For that reason, lithium remains his first-line treatment for maintenance therapy in bipolar disorder, despite the potentially dangerous side effects associated with too-high doses.
The increased use of Abilify for maintenance therapy may be leading to higher treatment costs for consumers, Tsai says. Abilify runs upwards of $600 for a month’s supply and is not yet available in a generic form. “But our main concern,” he adds, “is that patients are getting diverted from more effective treatments.”
Sonia Choi, the director of public affairs for Bristol-Myers Squibb, said in a statement that the company has conducted five long-term studies of Abilify in the maintenance of bipolar disorder, some of which were presented at medical conferences rather than published in peer-reviewed journals. (Dr. Tsai and his colleagues restricted their analysis to peer-reviewed randomized controlled trials.)
Bristol-Myers Squibb and Otsuka are committed to making data from those studies available to physicians, Choi said. “We are confident in the Abilify clinical development program and will continue to make available information about the efficacy and safety of Abilify from our studies in this and other indicated uses.”
Sandy Walsh, an FDA spokesperson, said the agency will review the new study.