Taxpayers Spend Billions Giving Children Antipsychotic Medications

 

Can you guess the best-selling class of drugs? It may be that a fifth of Americans suffer gastroesophageal reflux disease at least once a week, over 30% have hypertension, and over a third of U.S. adults have high LDL cholesterol, but the best-selling class of drugs isn’t proton-pump inhibitors for reflux, or angiotensin II receptor antagonists for blood pressure, or statins. It’s anti-psychotics.

 

The best-selling drug in America is Abilify, the prescribing information for which says it is only approved for:

 

  • Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
  • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
  • Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
  • Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

 

It’s commonplace for people to refer to themselves or others as “depressed” or “bipolar,” but that’s a far cry from a diagnosis. The NIH has a handy page with the statistics on mental illness. At the most generous estimate, 5-8% of the adult population can be diagnosed with Major Depressive Disorder, and Abilify isn’t even indicated for them — it’s indicated only for those who haven’t responded to typical antidepressants, which is half or less. Bipolar Disorder affects 2.6% of the popular, but Bipolar I, the more severe version defined by a week or more of mania or mania so severe it requires hospitalization, is only a small fraction of that. Schizophrenia affects 1% of the population. Finally, depending on your definition, between 0.8% and 1.2% of children have autism.

 

Adding all of those up gets us to 5% or so of the population that could even qualify for Abilify, less than a quarter of the people with GERD, hypertension, or high cholesterol. So who is taking all of this Abilify, and why? As the Wall Street Journal reported last week, “Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.” The quote Mark Duggan, a health-policy expert at the University of Pennsylvania’s Wharton School, saying that more than 70% of the cost of the five leading antipsychotics was paid for by Medicaid and other government programs.

 

While the public school system in many urban areas is in collapse — a problem we feel quite acutely here in Philadelphia — and there’s still no interest in putting tax dollars into early childhood education or after-school problems, and even the upper-middle-class can’t afford childcare so both parents can work, it seems Medicaid has $3.6 billion to spend on antipsychotic medications like Abilify, Zyprexa, Geodon, and Seroquel. (That’s just as of 2008 — the number is likely double or higher now given how rapidly prescriptions have grown.)

 

So what happened? Maybe it has something to do with this

 

[F]rom 2002 through the end of 2005, [Bristol-Myers Squibb] knowingly promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both “off-label” uses. … BMS directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients.

 

I’ve written several times before about off-label marketing, in which prescription drug and medical device companies illegally promote their products for uses that haven’t been approved by the FDA. That is, in fact, exactly what Bristol-Myers Squibb did: they pushed physicians to prescribe Abilify for uses far beyond the limited uses approved by the FDA — i.e., as a back-up to particularly severe versions of depression or bipolar disorder, or to treat the physical manifestations of rare conditions like schizophrenia and autism — to make Abilify prescriptions routine every time a child has a disciplinary or emotional problem.

 

The above quote comes from a Department of Justice press release from back in 2007, announcing that Bristol-Myers Squibb had settled a variety of False Claims Act cases brought by whistleblowers and the U.S. Government for $515 million. It sounds like a lot of money, but that amount — which was supposed to cover illicit profits and penalties relating to a variety of drugs, and a variety of illegal marketing schemes, including kickbacks, rebate fraud, and downright fraud on Medicaid — was less than the net sales of Abilify in 2012.

 

Five years after paying over half a billion dollars for systematically breaking federal law, the company is making money hand-over-fist with the best-selling drug in the country, the very subject of the unlawful promotion, and its stock price has almost doubled. Crime, it seems, does indeed pay if you’re a drug company.

 

Bristol-Myers Squibb is hardly alone in reaping billions from illegally marketing a powerful anti-psychotic medication as a convenient way to manage the behavior children and senior citizens. In 2009, Eli Lilly paid $1.415 billion to settle qui tam alleging it illegal “expended significant resources to promote Zyprexa in nursing homes and assisted-living facilities … to treat patients with disorders such as dementia, Alzheimer’s dementia, depression, anxiety, and sleep problems, and behavioral symptoms such as agitation, aggression, and hostility.” Later that year, Pfizer paid $2.3 billion to settle a variety of qui tam cases, including some involving Geodon. The next year AstraZeneca paid $520 million specifically for illegal marketing of Seroquel. That settlement detailed the depths to which these companies will sink to make a buck:

 

AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons. …

 

The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel. …

 

AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. …

 

Little wonder more than three-quarters of pediatric psychiatric medication appears to be off label and “atypical antipsychotics” are routinely used to treat “anxiety, dementia, eating disorders, obsessive-compulsive disorder, personality disorders, posttraumatic stress disorder, substance abuse.” (See this article, footnotes 17 and 27.)

 

There’s a lot of blame to go around here. First, of course, to the drug companies, for manipulating the research and then illegally pushing untested, powerful psychiatric medications as an easy behavior-modification strategy for unruly children and troublesome elders, a scheme worthy of Philip K. Dick. Second, to the doctors, for, at best, relying more on the pitch given by 20-something sales representatives than medical research or, at worst, selling their medical judgment for the price of a couple fancy dinners and trips.

 

But the government itself deserves considerable blame for allowing this to happen. It’s no secret Abilify, Zyprexa, Geodon, and Seroquel were fraudulently marketed, particularly to physicians who don’t specialize in psychiatric medicine and so have the least knowledge about how the drugs should and shouldn’t be used. Here’s a story about it in TIME from last year. Here’s a prior story in The New York Times from 2010.

 

None of this is a surprise; years ago, False Claims Act relators and their trial lawyers delivered the evidence and the arguments to the government on a silver platter, resulting in billions of dollars in recoveries for taxpayers. Did Medicaid forget about those? Did they expect the companies, having merely paid a toll for defrauding the public, would change their ways and repair the damage by talking physicians out of these prescriptions?

 

As much as I want to applaud the feds for finally digging into a big problem, this investigation should have been done years ago, back when the problem was starting — not years after the routine use of antipsychotics on children in lieu of other treatment became the norm.

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  • Eric Rasmusen

    You may be too hard on doctors, if not on the company. It is quite believable that an off-label use is extremely effective, and highly likely that it is safe, since it’s already been tested for safety in its label use. It just hasn’t been approved for the off-label use yet. Minor (that is, not hospitalizing) psychological ailments can be hard to pin down and treat using a standard procedure, because the symptoms aren’t easily made precise. So a doctor might be well advised to experiment and use his experience. If he finds the off-label use works, he ought to use it.

    That doesn’t make what Bristol did legal, or even ethical, of course. But the patients might have been helped

    • http://www.litigationandtrial.com/ Max Kennerly

      Those are fair points if we assume pharmaceutical companies start with rare indications and then move towards broader indications, but it’s usually the other way around. Pharmaceutical companies have every incentive to get FDA approval as broadly as possible, and so, when they file an application, they seek as broad indications for use as possible.

      Typically, an off-label use isn’t just something the pharmaceutical company hasn’t gotten around to studying yet, it’s a use the company tried to have the FDA approve and the FDA told them no. Off-label use is thus most commonly a use that cannot actually be justified by the evidence-based medicine.

      The safety of the medication is a similar issue: that is, by and large, dependent upon information provided by the companies to the FDA, and the companies have a long, long history of pruning and cherry-picking their data to suggest the drugs are safer than they are. Think of Vioxx. First, it was totally safe. Then, it was safe as long as you didn’t use it for 18 months, after which it was only a mild increase in risk. Now, it is recognized that the dangers begin within weeks, and that the overall risk profile suggests Vioxx has the same cardiovascular risks as smoking and diabetes.

  • Ralph Jacobson

    None of this is surprising, if you look at the prevailing ethos. A drug is viewed within the corporate structure just as any other product. The key parameter is growth. Assuming there is no additional FDA approval in the offing, that means off label use is the single source of growth out there. I was involved in one of these cases, and that was my conclusion.

    • http://www.litigationandtrial.com/ Max Kennerly

      Get it approved for something that affects 1% of the population, then market it to 20% of the population.