What do you do if your pharmaceutical drug lacks a clear competitive advantage and is connected to a long list of side effects? If you are Bristol-Myers Squibb with its Abilify, you spend millions on consumer and physician advertising, stay silent about the drug’s risks, and trump up its benefits.
This is Abilify’s story, a drug that was approved in the U.S. in 2002 to treat schizophrenia. Now, it’s also prescribed for bipolar disorder, as an add-on treatment for depression, and commonly used for off-label conditions like mood swings, irritability, and aggression.
While every prescription drug comes with potential side effects, most of the time the health benefits outweigh the risks. But in Abilify’s case, the benefits may be so negligible that the complication risk isn’t worth it.
Though Abilify has been on the market for more than 10 years, FDA-reported complaints are nowhere near declining. In fact, 2016 received the most complaints to date, with 5,398 reports overall, 822 reported hospitalizations, and 134 life-threatening complications. These included 944 reports for depression and 748 for suicidal thoughts, conditions that Abilify is supposed to treat.
Image courtesy of FDA Adverse Events Reporting System (FAERS) Public Dashboard.
But it’s the drug’s connection to sudden, unexplained compulsive behaviors that is the subject of recent litigation against Bristol-Myers Squibb and Otsuka (Abilify’s distributor and manufacturer).
According to the FDA Adverse Event Reporting System, hundreds of patients have experienced compulsive behavior while taking Abilify, including gambling addictions, compulsive shopping, hypersexuality, and binge eating.
These sudden desires can take control of patient’s lives, causing them to spiral into debt, sneak out of their homes, hide secrets from family members, and live with constant guilt. Compulsive and pathological gambling can particularly be devastating. Patrick Parks, for example, filed a complaint against Bristol-Myers Squibb and Otsuka in November 2016 after suffering from a gambling addiction that cost him more than $75,000.
While scientists are still unsure exactly how Abilify causes compulsive behaviors in some patients, it is likely to do with the drug’s effect on the brain’s dopamine receptors. Abilify helps to maintain dopamine levels in the brain: Too much dopamine can cause psychosis cognitive dysfunction, while too little can cause depression. Dopamine receptors control a number of important cognitive functions, including the brain’s rewards system which is where addictions can form.
Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices (ISMP), examined 1,580 cases involving patients suffering from compulsive behaviors while on dopamine receptor agonist drugs like Abilify. Moore found a causal relationship between Abilify and these behaviors, noting that in some patients the drug “triggers a pathological urge to gamble constantly, sometimes among persons with no previous interest.”
Every drug comes with a risk for side effects, but Abilify may lack any substantial health benefits to outweigh those risks.
According to a 2009 study conducted in Germany, Abilify is less effective than Zyprexa (olanzapine), and produces the same results as Risperdal (risperidone). And in a 2014 scientific review that compared Abilify to other antipsychotic medications, researchers concluded that though participants preferred taking Abilify, results proving its effectiveness or superiority were limited and “mostly of low or very low quality.”
So, given this data, why are physicians prescribing Abilify and why are patients taking it? The answer lies in a classic Big Pharma tale of hiding and denying unfavorable results, over-promoting drug benefits, and paying off physicians.
Though Abilify patients have reported compulsive behaviors as far back as 2005 and research has proved a causal relationship between the two since 2011, Abilify didn’t carry product label warnings for the condition until 2016. Europe carried these warnings as far back as 2012 though, so clearly it wasn’t an issue of Otsuka and Bristol-Myers Squibb not knowing of the risks.
At the same time that Otsuka and Bristol-Myers Squibb were downplaying Abilify’s side effects, they were also over promoting its alleged benefits in advertisements.
Between 2013 and 2014, Abilify outranked every other drug in direct-to-consumer advertising with a $121 million budget. On top of this, the company collectively issued $10.9 million in physician payments between August 2013 and December 2015 to encourage Abilify prescriptions. Abilify’s competitors spent significantly less: Zyprexa only spent $153,000 and Risperdal spent $393,000 during that same time period.
It wasn’t just the advertising budget that was limitless: The copy pushed boundaries, too. The FDA stated in a 2015 warning to Bristol-Myers Squibb that the, “FDA is not aware of any evidence to support the implication that Abilify offers significant advantages over other prescription drugs already approved for the treatment of bipolar disorder or MDD because of its pharmacology.”
But patients were largely unaware that there was scant data to support the advertising claims, and Abilify became the top-selling drug in 2013 with $6.5 billion in sales. In 2014, nearly 9 million Americans were prescribed Abilify, despite schizophrenia and bipolar disorder only representing 2.5% of the American population.
Some of Abilify’s new patients were children or seniors, even though Abilify wasn’t approved for these groups. The drug even carries a black box warning that elderly patients may have a higher risk of death while taking Abilify.
In the end, Bristol-Myers paid up for improperly marketing Abilify. They were hit with a $515 million fine by the Justice Department in 2007, and agreed to pay nearly $19.5 million in December of last year to settle claims filed by 42 states and Washington D.C.
Though Bristol-Myers has already paid millions of dollars for their deceptive marketing, they still have yet to face the claims of those patients whose lives were upended by Abilify-related addictions.
Lawsuits filed in a Florida multidistrict litigation allege Otsuka and Bristol-Myers Squibb failed to warn their American patients of Abilify’s risks, even though they knew or should have known about them. Complaints also accuse the company of spending millions in physician payments and misleading advertising that minimized the drug’s risks.
While these cases have yet to be decided, Otsuka and Bristol-Myers Squibb are entering litigation with a well-known history beset with controversy—a history that offers just one more example of how Big Pharma can create a market for any drug that they put their advertising dollars behind, regardless of the patients who may suffer the consequences.