The 1.4 million people who live in nursing homes are among the most vulnerable, powerless individuals in American society. They are old (mean age 79.2), they are physically frail (60% are unable to do 4 or more of the most basic daily activities), and most of them are cognitively impaired, many of them severely (39%). Nursing homes have come a long way since the bad old days when residents were tied up, neglected, and abused, and one of the stratagems for improving care has been the “care planning meeting.” A plan of care must be developed by the facility staff for all new admissions to nursing homes that are Medicare or Medicaid certified, addressing physical, emotional, and medical needs. These plans are reviewed on a quarterly basis—more often if there is a major change in status, such as a hospitalization. And one of the innovations of the last decade is to invite family members to participate in care planning meetings. This gives families information about their loved one and an opportunity to make suggestions and raise concerns. But one issue that neither staff nor families routinely raise and that the many websites that advise families about how to negotiate the unfamiliar nursing home terrain is medications. And that, specially in light of recent revelations, is an essential question.
The recent revelation is that Johnson & Johnson, the world’s largest drug company, just settled a variety of civil and criminal complaints about its sales of the psychiatric drug Risperidone (Risperdal) for $2.2 billion (yes, that’s billion) J&J “accepted accountability” for misbranding Risperdal as useful for treating elderly patients with dementia, for marketing Risperdal for the elderly, and for paying kickbacks to both physicians and to Omnicare, the largest pharmacy supplying nursing homes, for using the drug.
It’s been known for quite some time that drugs like risperidone, an “atypical” neuroleptic used in the treatment of schizophrenia, come with considerable side effects. Though less likely to cause Parkinsonian symptoms than earlier “typical” neuroleptics such as chlorpromazine (Thorazine) or haloperidol (Haldol), it can cause sedation, low blood pressure, and dry mouth, among other symptoms. Then it was shown to increase the risk of diabetes and weight gain. And a meta-analysis in 2005 found it increased the risk of sudden death by death by 60-79%, which led to the FDA issuing a “black box” warning—a warning on the risperidone label highlighting its hazards. Families and physicians might have been willing to accept the risk of side effects and even of death when the drug was used in people who were already very old and very sick if it had been effective. Unfortunately, a series of studies looking at whether risperidone and other “atypical neuroleptics” (similar drugs in the same class) were effective in controlling the behavioral symptoms of dementia—problems such as agitation or paranoia—found only limited evidence that it achieves these goals.
Since behavioral symptoms are often very difficult to control and create problems both for the patient and for nursing homes, physicians have continued to use neuroleptics including risperidone “off label,” that is for uses other than those for which the FDA approved them. This is an entirely legitimate practice. What is not legal is for drug companies to advertise their drugs for use in these conditions or to bribe physicians or pharmacies to use the drugs.
The Justice Department is hoping that the new settlement (in which, by the way, J&J does not admit any wrongdoing) will stop the prevailing practice and serve as a deterrent to this kind of behavior in the future. Given that GlaxoSmithKline settled with the government last year for $3 billion over similar behavior with respect to two antidepressants (Paxil and Wellbutrin), along with a diabetes drug, and that Pfizer made a payment of $2.3 billion in 2009 over inappropriate marketing of several other drugs, it’s not so clear that ithe deal will deter outrageous behavior. It is entirely possible that settlements of this kind are seen by Pharma as the cost of doing business. Everybody misbehaves all the time; occasionally a company is caught; on balance, a periodic payoff may be worth the tremendous benefits. After all, at its peak in 2007, J&J sold $4.5 billion worth of Risperdal. The company has now signed a 5-year “corporate integrity agreement” in addition to paying the fine, but analogous agreements signed by medical device manufacturers in the past led to no substantive changes in behavior.
So in those care planning meetings in the nursing home, if they ask nothing else, family members should ask “what drugs is mom on?” And that should be followed by “why is she on them?” and “are they helping?” And if there is no good reason for giving the medication, ask that it be stopped, especially neuroleptics. It will save mom a lot of misery—and save money for all of us.