MAXIMIZING THE HEALTH OF WOMEN WITH EPILEPSY - SCIENCE AND ETHICS IN NEW DRUG DEVELOPMENT

Issues of unique concern to women with epilepsy largely arise from gen der-based physiological differences. Female sex steroid hormones may a lter the expression of epilepsy and the efficacy of antiepileptic drug s (AEDs). Seizures and AEDs in turn affect the hypothalamic-pituitary axis and can adversely impact reproductive function and bone health. M aternal seizures and exposure to AEDs may compromise fetal development . At this time, women with epilepsy and their medical caretakers do no t have access to all the information necessary to formulate a treatmen t plan that will have the least impact on reproductive and general hea lth. In part, this is because reproductive aged women are excluded fro m the earliest phases of drug testing and pregnant and lactating women are excluded from all aspects of new drug development. Therefore, as new AEDs enter the marketplace, women with epilepsy must decide whethe r a new AED is appropriate for therapy based on very limited informati on. Postmarketing surveillance of gender-specific adverse effects, as with all adverse effects, depends on voluntary reporting. Only a small percentage of significant adverse events are believed to be captured by the present system. Consumers, ethicists, and some physician groups are now arguing that women should be included in all aspects of the d evelopment of drugs they will ultimately use-even pregnant and lactati ng women. Some of the issues of concern for women with epilepsy regard ing epilepsy treatment, reproductive function and general health will be reviewed, followed by a discussion of the drug development process and how it does, and could better, address the concerns of women.