Abstract:
:This article explores the historic underpinnings of the exclusion of women from clinical drug trials, identifies recent developments, and examines legal implications for women with epilepsy and for others. Distinguishing stakeholders and their interests may lead to policies that better serve all. Past and present statutory, regulatory, and judicial frameworks were reviewed, as well as legal, medical, and historical commentary. Traditionally, researchers and manufacturers have not tested particular drugs on women. Physicians and pharmacists routinely prescribe and sell these same medications regardless of gender. Only since 1993 have females been more likely to be included in clinical drug trial subject pools. The impact of past and future practices on health care provision and legal liability remains unknown. A policy of "Don't test, do sell" will not protect women with epilepsy or would-be defendants. At this time the most effective shields will involve procurement of informed consent as well as testing of both women and men. In the long run, tort, health care, and regulatory reform will best serve all interested persons. Inclusion of women in clinical drug trials has become a how question, not an if one.
journal_name
Epilepsiajournal_title
Epilepsiaauthors
Herz SEdoi
10.1111/j.1528-1157.1997.tb04538.xsubject
Has Abstractpub_date
1997-01-01 00:00:00pages
S42-9eissn
0013-9580issn
1528-1167journal_volume
38 Suppl 4pub_type
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