How this antipsychotic became America’s best-selling drug

Gotta be a best-seller in here somewhere…
Gotta be a best-seller in here somewhere…
Image: Reuters/Srdjan Zivulovic
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The 16 million American adults (or 6.9% of the country’s population) with major depression are a prime target for big pharma. Not only does this group of drug consumers use traditional antidepressants with a vengeance. They are also candidates for far more expensive antipsychotic drugs used to treat less-common disorders, like schizophrenia or bipolar disorder, which can help with depression when paired with a traditional antidepressant.

The most popular of those drugs—and the best-selling drug in the US—is Abilify, or aripriprazole. The drug saw sales of $7.5 billion from October 2013 through September 2014. Abilify isn’t one of the most-prescribed medications, according to the medical website Medscape. But it is expensive, costing around $800 for a bottle of 30 tablets, and that high price explains the high sales numbers.

Nonetheless, $7.5 billion is a huge sum for a drug originally meant to combat bipolar disorder and schizophrenia, which each affect only 2.6% and 1.1% of American adults, respectively, according to the US National Institute of Mental Health. The drug is approved for both adults and children.

So how did the drug rise to the top? Regulations and advertising may have played some part. Scientists found in a 2006 National Institute of Mental Health study that augmenting an antidepressant with another antidepressant or medication can help patients overcome major depressive disorder.  In 2007 the US Food and Drug Administration approved Abilify as an add-on drug to treat major depressive disorder. That set off a huge advertising campaign, which has raised questions about the accuracy of its explanations as to what the drug does.

An academic article cited by the Daily Beast explains that advertisers often use a simple explanation of serotonin imbalance to explain how depression happens, and antidepressants, or antipsychotics like Abilify, in turn help by getting rid of that deficiency. The paper, in the journal Public Library of Science, Medicine notes, “Antidepressant manufacturers commonly advertise their products by claiming that depression is caused by a lack of serotonin and that selective serotonin reuptake inhibitors normalize this deficiency, a claim not congruent with the peer-reviewed literature or FDA-approved product information.”

Add to aggressive advertising that doctors are prescribing the drug for less severe illnesses the FDA has not approved it for, such as anxiety.

Perhaps most worrisome is that America’s best-selling drug is not well understood. A Daily Beast analysis of the literature around Abilify concluded that while the drug is considered effective, the mechanics of how it works remain unclear. That should give pause to its consumers, especially since its gatekeepers don’t seem to mind.