Abilify Tops the Drug Best-Seller List

The latest figures are out, and according to Drugs.com, the No. 1 best-selling drug in America (in dollar volume) is now Abilify, an atypical antipsychotic. (The No. 1 drug in the U.S. in terms of number of prescriptions is oxycodone.)

Abilify (otherwise known as aripiprazole) was approved by the U.S. Food and Drug Administration for schizophrenia on November 15, 2002. It got approval by the European Medicines Agency on 4 June 2004. It goes off-patent in October 2014. Until then, there is no generic formulation.

Source: Drugs.com.

Why is an atypical antipsychotic drug suddenly selling so well in the U.S.? Several reasons.

Abilify is widely prescribed as an adjunctive (or supplemental) medication for depression. Korea Otsuka Pharmaceutical Co., Ltd., which markets Abilify jointly with Bristol-Myers Squibb (BMS), received FDA approval for the drug's use as an adjunct for major depressive disorder on November 20, 2007; and to treat irritability in children with autism on 20 November 2009.

But that's not the whole story. Abilify is also widely prescribed off-label, to treat a variety of conditions in children, plus dementia (Alzheimer's disease) in the elderly. While it's not illegal for doctors to prescribe drugs in an off-label way, the off-label use of antipsychotic drugs (for children, especially) is ill-advised, given the potential for adverse side effects and the lack of efficacy data for such uses. It should be noted that Bristol-Myers Squibb was fined $515 million in September 2007 for recommending off-label uses of Abilify (among other charges).

One thing is certain: Abilify didn't make it to the top of the charts by virtue of its efficacy (which, as an adjunct to antidepressants, is only slightly better than placebo). It made it there, in part, by a massive advertising campaign in the U.S. that urged Americans to their doctor and "ask if Abilify is right for you."

It also made it to the best-seller list by a variety of flat-out underhanded marketing practices. Bristol-Myers Squibb's 2007 settlement agreement with the U.S. Government was based on the Justice Department's contention that:

BMS knowingly and willfully paid illegal remuneration to physicians and other health care providers to induce them to purchase BMS drugs. BMS paid the illegal remuneration in the form of consulting fees and expenses to physicians and other health care providers to participate in various consulting programs, advisory boards, and preceptorships. Some of these programs involved travel to luxurious resorts. The Government also alleged that, from 1994 through 2001, Apothecon [a BMS wholly owned subsidiary] knowingly and willfully paid illegal remuneration such as stocking allowances, price protection payments, prebates, market share payments, and free goods in order to induce its retail pharmacy and wholesaler customers to purchase its products. [from press release]

It's a simple formula for success, really. Come up with a drug that works no better than older medications, for a condition (schizophrenia) that only 1 in 100 people have; announce that it's a wonder drug; pay doctors to prescribe it; encourage physicians to find untested uses for it; pay "stocking allowances" to drug stores; tell consumers who almost certainly don't need it to ask their doctor for it; and meanwhile set its price so high that it's 100 to 200 times more valuable, ounce for ounce, than pure gold.

What could possibly go wrong?