Ethical and Practical Benefits of the New Atypical Antipsychotic Medications

By S. Van McCrary, Health Law & Policy Institute

The Texas Legislature and the Texas Department of Mental Health and Mental Retardation currently are evaluating the potential benefits and burdens of increased prescribing, and corresponding increased state funding, of recently-developed atypical antipsychotic medications for schizophrenic patients.

The new generation of antipsychotic drugs in the U.S. began in 1990 with the approval of clozapine for treatment-resistant schizophrenia. Clozapine, however, has numerous severe side effects which require constant physician monitoring and blood testing, thus making it virtually a treatment of last resort. The first of the new atypical antipsychotics was risperidone, which was approved for use in the U.S. in 1994. The efficacy of risperidone is at least equal to haloperidol, the standard treatment for many years, and has far fewer and less severe side effects. Other new atypical drugs include olanzapine, approved in 1996, and quetiapine, approved in 1997. Further, a number of newer antipsychotic medications are currently in large-scale clinical trials or are awaiting FDA approval. The clinical effects of these newer antipsychotics tend closely to resemble clozapine, but they do not have clozapine’s severe side effects.

It is important not to underestimate the impact of side effects of various psychoactive medications. All of the standard antipsychotic drugs are associated with potential for developing severe, and sometimes permanent, neurological side effects, known as "extrapyramidal motor effects." The physical manifestation of these side effects include acute muscular rigidity and cramping, tremors, gait disturbances, drooling, agitation, and involuntary abnormal movements of the lips, tongue, and facial muscles. These effects are extremely unpleasant to patients and in some circumstances can be life threatening. Researchers have estimated that at least 20 percent of patients treated with standard drugs will develop such symptoms. Research also indicates that most patients with schizophrenia will discontinue the standard drugs within a year or two as a result of these side effects. One of the most frequent reasons for psychiatric readmissions to hospitals is repeated discontinuation of medication after leaving the hospital. This need for frequent rehospitalization has a significant impact on patients’ social functioning--including implications for employment, schoolwork, and ability to live independently--and has often been referred to as the "revolving door syndrome" because some patients have dozens of admissions over the course of several years. As a result of this pattern of repeated discontinuation of medication, relapse and hospitalization, many psychiatrists now recommend the new atypical antipsychotic medications as "first line" therapy for schizophrenia. These new drugs are, however, extremely expensive when compared to the cost of traditional antipsychotic drugs such as haloperidol.

The ethical implications of failing to prescribe atypical antipsychotic drugs are significant. First, the reduced physiological effects of the new drugs are likely greatly to increase patients’ comfort level and overall quality of life while taking antipsychotic medication. The direct benefit to patients is thus substantial. Further, patients whose lives have been so improved are more likely to be functional and productive members of society, thus potentially reducing burdens on society from uncontrolled schizophrenia such as increased incarceration, hospitalization, unemployment, and other related social factors. Cumulatively, these factors suggest that both patients and society can be significantly benefited by increased prescribing of atypical antipsychotics for appropriate patients. Support for these ethical arguments is bolstered by at least the potential for cost savings to government. The issues of side effects and aggregate cost to the state are inevitably interwoven because of the revolving door syndrome and the high cost of inpatient psychiatric treatment. These concerns pose the question whether it may be less costly in the long run for states proactively to fund atypical antipsychotic medications for all eligible schizophrenic patients in an effort to avoid later hospitalization.

12/08/98