Psychopharmacological drug testing in women

It has been estimated that the current development cost for a new drug before it can be marketed is over $200 million. The average time for this development process is 12 years. Recommending required arbitrary inclusion of equal numbers of women -in all studies, at all stages of clinical investigation, for all new drugs- could be counterproductive, because it would further increase the costs of drug development and produce delays in clinical availability of new drugs. In the process of developing guidelines for the inclusion of women in clinical trials of new medications, it is important not to ignore the potential detrimental effect on drug development or costs that excessively rigid testing requirements could have. Significant cost increases could lead to sponsors' decisions to limit some types of new drug development. The cost of drug development is of particular relevance now, since pharmaceutical firms are addressing the need for cost containment in anticipation of health care reform changes. However, in the case of antidepressants and other psychotropic drugs for which women are the predominant consumers, women should be included early and should be adequately represented in all phases of drug development. Such inclusion is necessary in order to determine whether there are sex-related differences in efficacy, safety, or dosage recommendations and thus optimize psychotropic drug treatment for women. Recommendations for changes in the current drug development procedures must take into consideration balancing an acceptable degree of potential risk to a foetus against the benefits of ensuring that women's special health concerns are factored into assessment of the safety and efficacy of drugs they will be taking. It is hoped that the increased attention recently focused on women's health issues and the changes in policy at FDA and NIH will result in research that will broaden the data base with respect to all aspects of drug therapy for women. Important areas of drug evaluation in women that have been long neglected should be systematically assessed for new psychotropic drugs. The general lack of drug studies in the very elderly affects the treatment of women, because women tend to live longer than men and hence are overrepresented among the elderly. This neglected area of psychopharmacological drug evaluation should also receive more attention. (Author' s abstract)