Abilify (aripiprazole) has become the best selling drug in the United States, topping $1.5 billion in the third quarter of 2013, outselling Nexium, the second-best selling drug. How is it that Abilfy, approved by the Food and Drug Administration (FDA) primarily for the treatment of schizophrenia and acute mania in bipolar disorder, can outsell a drug like Nexium that is used to treat heartburn?
The answer is that Abilify is being prescribed “off label” for a wide range of conditions for which the drug is not FDA approved. I did a small study of my own patients and found that 2.8 percent (or 4 out of 145) were taking Abilify. But only one patient had a diagnosis of schizophrenia or acute mania. All of these patients had been prescribed Abilify by other doctors. The reasons for the other three-quarters of the prescriptions were not clear to me.
This would be bad enough if Abilify was a safe and inexpensive medication. Unfortunately, it is neither.
Like all antipsychotic medications, Abilify is a powerful drug that also comes with serious and potentially dangerous side effects. Tardive dyskinesia—a permanent movement disorder that has no cure—is associated with Abilify and other antipsychotics. Neuroleptic malignant syndrome, a rare but sometimes fatal complication that causes high fever and shock, is also associated with Abilify and these other drugs.
More common adverse effects include episodes of low blood pressure that can cause falls and high blood sugar that can lead to diabetes. And all antipsychotics cause significant changes in a person’s thought patterns and behavior. Remember the film and book “One Flew Over the Cuckoo’s Nest”? These were the drugs that were known as “chemical straitjackets.”
And Abilify is expensive. A 30-day supply of the lowest dose costs more than $825. Older antipsychotic drugs like haloperidol cost as little as $4 a month. Whatever the cost, antipsychotic drugs are invaluable when treating the devastating symptoms of schizophrenia or acute mania. Due to their potentially serious risks, antipsychotic drug shouldn’t be used except when absolutely necessary.
One reason Abilify is prescribed so often for uses other than those approved by the FDA is illegal marketing for off-label use by pharmaceutical sales representatives. Bristol-Meyers-Squibb paid $515 million in 2007 to settle an investigation into illegally promoting the off-label uses of Abilify.
That penalty—the third largest for any drug company at that time—is what Bristol-Meyers-Squibb makes from Abilify sales in one month.
If you want to be cynical about it, the message to drug companies is—crime pays. No one went to jail. Sales of Abilify are booming. Shareholders are happy.
The sadder truth is that Bristol-Meyers-Squibb is not alone. Most of the biggest drug manufacturers have paid large fines for illegal off-label promotion. Two drugmakers—Abbott and Eli Lilly—like Bristol-Meyers-Squibb, targeted their marketing to doctors and nursing homes to boost the unapproved uses of strong antipsychotics to treat seniors with dementia, all the while knowing that these drugs caused an increased risk of death in this vulnerable population.
So what about the patients who were put on Abilify or one of these many other drugs inappropriately? How many are walking around like zombies? How many have fallen and broken bones? How many have developed diabetes? How many are plagued by involuntary muscle contortions that can never be cured? And how many have died?
Consider, too, the economic cost to the rest of us who have to pay higher premiums for our health insurance and higher taxes to pay for government health programs.
A slap on the wrist with a fine that can be recouped in a month will never stop illegal marketing by drug companies. Not when the profits that accrue from such illegal activity will go on for years and years.
Sales reps, their supervisors, and, most importantly, the company executives need to be put behind bars to make this practice stop. This isn’t just a white collar crime. Innocent patients are suffering and dying as a result of corporate greed.
Future fines and settlements need to be so large as to deter executives from making the cold calculus that illegal marketing will pay off. For instance, antitrust laws allow fines that are three times the amount of any ill-gotten gain made from illegal conduct. When drug companies put patients at risk, they should face fines at least this big, or preferably even bigger.
And a good portion of the fine should go into re-educating the public and prescribers about the dangers of the illegally promoted off-label uses of the drug. Well-designed advertisements about how the company misled or lied to doctors and warning about the risks patients could be facing could be as effective as anti-smoking commercials used to be to get people to stop smoking.
To put an end to illegal off-label marketing, we need to make the drug company executives feel the same pain as the patients they’re afflicting. We need to make sure that this crime doesn't pay.
-- Stephen R. Smith, M.D., M.P.H.,
Community Catalyst physician consultant