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The usefulness and use of second-generation - page 3 / 81

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Preface

Second-generation antipsychotics, as well as other new methods of treatment, raise problems of equity. The costs involved in the development of drugs make them expensive. Under the current circumstances new (and more expensive) medications will not be available to many patients in developing countries; even patients in developed countries might find it difficult to afford them.  The lack of knowledge about new medications and the fact that these medications may not be fully covered by public or private reimbursement schemes further contribute to their lesser use.

The proposals to limit the life time of patents to several years after which generic medications are produced is not a satisfactory solution because patients who need the medications now may get them only after many years.  Limiting the duration of patents may also be a disincentive to research investments and the discovery of new and more effective drugs, and may increase the number of orphan diseases for which few new medications will be developed.

To examine possible solutions to this type of problems in the case of second-generation antipsychotics, the World Psychiatric Association (WPA) appointed a Task Force chaired by Prof. Norman Sartorius in order to: (1) review the evidence of the efficacy, tolerability and costs of new medications in comparison with more traditional medications, and to analyze the impact that the availability of these medications has had on the way patients are treated; and(2) to propose to the WPA some action concerning relevant health policy issues.

The WPA Task Force undertook an in-depth review of the published scientific evidence on second-generation antipsychotics. This review included evidence on the results of studies comparing second-generation antipsychotic medications with other drugs in terms of efficacy and tolerability.  It analyzed evidence about the impact of the new medications on the way patients are treated, on the overall cost of treatment and on the impact that the use of these drugs has (or could have) on the burden of psychotic disorders and on the stigma associated with them. In order to address such broad goals, the Task Force included experts representing those concerned with the care of people with psychotic disorders (psychiatrists, psychopharmacologists, care-givers, persons working for the health care administration, and others) and consulted a large number of individuals and organizations involved in work in this area in many countries.

A review of scientific data about a treatment can produce three levels of evidence. When well designed, adequately powered randomized, controlled and blinded  studies show consistent results of clear superiority of a treatment over another, it is possible to consider the use of such a treatment as a standard procedure.  When this is not the case, the scientific community may extrapolate from the evidence base using less rigorous studies, case reports, clinical experience and expert opinion to reach consensus  and produce guidelines. In the absence of this, all treatments become options.

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