Antipsychotics, Economics, And the Press

When was the last time that the results of an NIMH study on schizophrenia made the front page of the New York Times? The first phase of results of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) was published in the New England Journal of Medicine in its September 22 issue. In this “real world” prospective study, 1,500 outpatients with schizophrenia were randomly assigned to one of four atypical or one typical antipsychotic medication and then followed over 18 months.

The findings indicated that a very high percentage of the patients (nearly three-fourths) discontinued their assigned medication before the 18 months due to intolerable side effects, lack of efficacy, or some other reason. There were few differences among the five medications in terms of rates of discontinuation or efficacy. Patients in all groups showed only modest improvement in their average symptom scores over time.

Dr. Jeff Lieberman and colleagues, who conducted the study, should be commended for this “head-to-head” study of antipsychotic medications. Unlike in most other psychopharmacologic studies, participating patients were allowed to receive other psychotropic medications and were studied for an extended time period. This study is likely to have profound implications for clinical practice and for the policy decisions that are likely to be made as a result of the high cost of atypical antipsychotic medications.

Medicaid today spends more than $3 billion per year on antipsychotic medications—more than any other drug class. The newer drugs account for $10 billion in total annual sales and account for 90 percent of the national market for antipsychotics. The use of typical (or older) antipsychotic medications has dropped dramatically in the last decade. The atypical antipsychotics cost much more than the older drugs, depending on the drug (from three to 10 times more). Many state Medicaid programs are short on funds in part because of the high cost of schizophrenia drugs.

Newspaper stories underscored the implications of the study for state Medicaid programs and other payers. Further, the stories were both implicitly and explicitly critical of the marketing by Big Pharma. As the New York Times editorial accompanying its September 20 front-page story stated,“ A government-financed study has provided the strongest evidence that the system for approving and promoting drugs is badly out of whack.... The nation is wasting billions of dollars on heavily marketed drugs that have never proven themselves in head-to-head competition against cheaper competitors.” The newspaper stories also underscored the fact that antipsychotic drugs are very much a halfway technology and that patients are better after taking them but certainly not well. Again, as the New York Times stated, “The current state of schizophrenia treatment leaves a lot to be desired.”

The results of the study should be of deep concern to psychiatrists as we struggle with this extraordinarily disabling illness. One implication is that this is a cautionary tale on the reliance we have all had on Big Pharma promotions as the major source of information about the newer drugs' presumed superiority to the older agents. Better efficacy and lower side effects are undoubtedly found by some patients who use the newer versus the older medications; however, the wholesale benefits of these newer medications compared with the older ones were not confirmed by the first phase of the CATIE study. Second, the press coverage of the New England Journal of Medicine report did not emphasize, as the authors of the study did, the need for individual choice about the best antipsychotic medication regimen for patients who may have differences in family history, weight concerns, co-occurring conditions, and other factors.

It would be regrettable if the main impact of this study and its press coverage was on the economics of treatment instead of the clinical needs of patients with this devastating disorder.

Psychiatrists need to be more aware of the efficacy of the less expensive, older medications compared with the newer medications when evaluating and recommending treatment for patients with schizophrenia. Just because a medication costs more doesn't mean that it has superior efficacy. But just because a medication costs more doesn't mean that the medication should not be part of an approved formulary. The CATIE study highlights what we already know as psychiatrists—antipsychotic medications are an incomplete treatment in enabling patients with schizophrenia to overcome their illness. We need accessible psychosocial treatments in addition to medications in order to help patients regain their social and vocational functioning and progress to recovery. ▪