Abilify (aripiprazole) is an atypical antipsychotic medication commonly used to treat schizophrenia and acute mania. In 2005, the Food and Drug Administration (FDA) approved its use in the maintenance treatment of bipolar disorder – to prevent the recurrence of mood episodes. Unfortunately, evidence proving the effectiveness of Abilify as a maintenance medication for bipolar disorder is scarce and questionable.
An article published this week in the open access journal PLoS Medicine (Tsai et al) looks critically at the scientific evidence that supports such widespread use of this medicine for maintenance treatment of bipolar disorder. They found only one blind, randomized, controlled trial to support the use of Abilify in the long-term maintenance of bipolar disorder. (A blind, randomized, controlled trial is the type of study considered most valid and useful in scientific research like this.) Furthermore, this trial was sponsored by Bristol Myers Squibb, the pharmaceutical company that markets Abilify in the U.S. The new study raises a number of concerns about the quality of the trial itself:
Despite this, the authors of this review in PLoS Medicine found that this one trial was cited 80 times by other authors, and these citations typically suggested that definitive evidence supported the use of Abilify in maintenance treatment. However, few of these citations – only four – mentioned any of the potential flaws in the study or that it was sponsored by the company that markets the medication.
This whole story is a travesty for the medical profession – and for psychiatry in particular. We are prescribing a medication in massive numbers with woefully inadequate scientific research to support it:
Doctors rely on a variety of sources for information to help them in making medication decisions – in this case the power of the data was clearly limited, but the literature presented it as firm science and well supported. Are we lazy? Are we not critical thinkers anymore? Are we just too busy trying to make a living that we don’t have time to do our own careful review of the data? Why aren’t we much, much more skeptical of all studies sponsored by drug makers? Why aren’t we demanding more strong, independent science to help our patients and to reduce the use of unnecessary or inappropriate medication?
I use Abilify in my practice, but extremely cautiously. I think that if we were more aware of how much of the research we rely on is flimsy and drug-company sponsored we would all be far more cautious in our prescribing patterns.
Abilify may or may not be effective in the maintenance treatment of bipolar disorder. We simply do not have enough reliable evidence to determine whether it is or is not. Abilify has proven effective in treating acute symptoms of bipolar mania. Here’s what you should know:
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Last reviewed: 6 May 2011