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tazzygirl -> RE: Could funding be lacking because this is a male only cancer? (1/4/2013 10:22:06 PM)
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Women have traditionally been underrepresented in clinical trials. In order to translate recent advances in our understanding of the molecular and physiological bases of sex differences into new therapeutics and health practices, sound sex-specific clinical data are imperative. Since the founding of the Office of Research on Women’s Health within the Office of the Director at the NIH in 1990, inequities in federally funded biomedical research, diagnosis, and treatment of diseases affecting women in the US have been reviewed. Discussed herein is the evolution of gender-related research innovations, primarily within the last decade, and strategies and challenges involved in the success of this recent development.
Until 1988, clinical trials of new drugs by the US Food and Drug Administration (FDA) were routinely conducted predominantly on men (8), even though women consume approximately 80% of pharmaceuticals in the US. The results of male-only clinical trials have led to the development of diagnoses, preventive measures, and treatments that are commonly extrapolated to women, yet the reverse is rare. In 1992, a survey by the US General Accounting Office, the body responsible for the audit, evaluation, and investigation of Congressional policy and funding decisions, found that less than half of publicly available prescription drugs had been analyzed for sex-related response differences (9). A consequence of extrapolating the results of male-only clinical data to female consumers is that women were (and still are) typically prescribed dosages devised for men’s average weights and metabolisms. For example, it is now known that acetaminophen, an ingredient in many pain relievers, is eliminated by the female body at approximately 60% the rate of elimination documented in men (10). The administration of drugs to women at dosages designed for men can place women at risk for overdose. Furthermore, while little is known about the effects of aspirin on heart disease in women, postmenopausal women, like men, have been encouraged to take aspirin daily. The effects of other widely used drugs, such as Valium, were never tested in randomized clinical trials with female subjects, although 2 million women per year consume this drug to control conditions such as anxiety, epilepsy, muscle spasms, and alcohol addiction.
nvestigators have defended their choice of males as research subjects on the grounds that men are cheaper and easier to study. The estrous cycle is viewed as a methodological complication during analysis that increases research costs because many more control groups are required. Researchers have also feared that the inclusion of women of childbearing age in clinical trials might endanger fetuses. FDA guidelines restricting research on women of childbearing potential were first implemented in 1977 in reaction to the birth defects resulting from thalidomide and diethylstilbestrol administrated during pregnancy, and the FDA only revised these guidelines to include this population of women in early-phase clinical trials in 1993. These protective restrictions, however, can support the portrayal of women as “walking wombs,” unable or unwilling to control their fertility. These guidelines also overlooked the pharmacologic needs of many pregnant women, three-quarters of whom require drug therapy during pregnancy and currently use prescription or over-the-counter drugs for chronic conditions such as diabetes or depression (11).
http://www.jci.org/articles/view/19993
Just to back up your post before demands of "proof" start being demanded.[;)]
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