June 18, 2017

The Other American Drug Problem

With all the attention paid to the opioid epidemic, another drug overuse problem has gone relatively unnoticed--the widespread use of antipsychotic medications in nursing home residents. A perspective article in JAMA this week focuses on this other drug problem—and an intervention that the authors think might just have solved it.
Interestingly, antipsychotic medications were a problem in an earlier era. Then along came OBRA87, or the Nursing Home Reform Act, mandating a variety of strategies limiting the use of drugs to sedate patients with dementia who had behavioral problems: nursing home patients were to be free of “chemical restraints;” staff were supposed to try non-pharmaceutical approaches before resorting to drugs, and they were expected to taper the medication after several months. The regulations seemed to be effective: the percent of nursing home residents receiving an antipsychotic fell from 34 percent pre-OBRA to 16 percent several years afterwards.
But after the atypical antipsychotics were introduced in the early 1990s, beginning with risperidone and then going on to a variety of other agents such as quetiapine and olanzapine, the rate of use began climbing again. By 2011, it had reached 24 percent among nursing home residents. Today, however, it’s back down to its historic low of 16 percent.
In their article, Gurwitz et al regard the turning point as the Office of Inspector General report of 2011, “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents.” In response to this alarming report, the Centers for Medicare and Medicaid Services (CMS) developed a multi-pronged strategy to combat the problem. It launched its “National Partnership to Improve Dementia Care in Nursing Homes,” which combined public reporting, educational resources, and renewed regulatory enforcement. Gurwitz et al assume that it was this partnership that led to the fall in use of antipsychotic medications.
But that’s not the whole story.
If we look at why the use of antipsychotic medications began to rise again in the 1990s, what we see is a massive push by Big Pharma to peddle these drugs to nursing homes, even though they are not FDA approved for the treatment of the symptoms of dementia. Not only have studies failed to demonstrate that the antipsychotics (whether “typical” antipsychotics such as haloperidol or the “atypicals” such as risperidone) work in dementia, but the FDA also issued a black box warning indicating that they have been associated with sudden death. The drug companies were undeterred. They employed various strategies to achieve spectacular sales of atypical antipsychotics in the nursing home.
Janssen, a subsidiary of the mega-company Johnson &Johnson, went so far as to create what it called “ElderForce,” a special group of drug reps who were deployed to market the antipsychotic Risperdal (risperidone) to doctors in nursing homes. Now it’s perfectly legal for doctors to prescribe an FDA-approved drug “off label,” that is, for some other non-approved use. But it’s not legal to advertise drugs for non-FDA-approved indications. What Janssen did was to pay its ElderForce reps a commission for every prescription the doctors wrote. J&J was not alone in promoting antipsychotics to nursing home physicians for use in their troublesome patients with dementia. Eli Lilly did the same for its atypical antipsychotic, Zyprexa (olanzapine). It was evidently a winning strategy: Astra-Zeneca followed suit with its drug, Seroquel, and, not to be left out, Bristol-Myers-Squibb tried it with Abilify. The leading distributor of prescription drugs to nursing homes, Omnicare, got a piece of the action when it instructed its pharmacists to provide disinformation to nursing home doctors—in return for a kickback from Abbott, the company that manufactured the drug it was pushing for treating the behavioral symptoms of Alzheimer’s disease, the anti-seizure medication, Depakote (which like the antipsychotics, is not approved for this indication).
Slowly and methodically, the Department of Justice reacted. And what followed was a dramatic series of investigations that ultimately resulted in penalties for the malfeasants. Sometimes the payouts were probably too small to have much of an effect—the $520 million that Astra-Zeneca paid in 2010 to settle charges of illegally marketing Seroquel (quetiapine) in nursing homes could be viewed as just the cost of doing business. But even for Eli Lilly, the $1.4 billion it paid to settle civil and criminal charges relating to the marketing of Zyprexa  (olanzapine) was substantial. And when Johnson&Johnson paid $2.2 billion in criminal and civil fines in 2013 to settle accusations that it improperly promoted Risperdal (risperidone) for use in nursing home residents, all the drug companies took notice.
So yes, I think CMS is onto something when it acknowledges that the problem of the overuse of antipsychotics in nursing homes is multifactorial, and it’s right to look to nursing home chains and physicians, as well as to educational tools and regulatory incentives in its quest for reform. But let’s not forget that one of the “stakeholders” is the drug companies and that the legal system can be a powerful change agent.

No comments: