Thursday, April 15, 2010

Gender Disparity in Drug Trials


For my previous post on One Size Fits None, I did some digging (with the help of the
Medical Anthroplogy community and a librarian at OHSU). I found a number of really interesting sources discussing the gender disparity in drug trials, and thought I'd list them here.

Since I do not have deep research in this area, I will decline in-depth comment. The upshot is, that although the NIH guidelines require "inclusion of women and minorities" - it is clear we have a long way to go.


Organizations


Books

Women and health research : ethical and legal issues of including women in clinical studies / Anna C. Mastroianni, Ruth Faden, and Daniel Federman, editors ; Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, Division of Health Sciences Policy, Institute of Medicine.
Imprint Washington, D.C. : National Academy Press, c1994.

Women's Health - Missing from U.S. Medicine by Sue Rosser. (this can be read online)


Journal Articles
Brettelll, C. and Sargeant, C. (1996) 'Gender and Health an International Perspective'.

Corrigan, O.P. (2002). ‘First in man’: The politics and ethics of women in clinical drug trials. Feminist Review, 72, 40–72. Info here and here. (Pay to access)

"concern about danger to the unborn foetus has meant that, until very recently, ‘women of childbearing potential’ were routinely excluded from most of the early phases of clinical drug testing...exclusion of women during the early phases of clinical drug trials has now been lifted and drugs are currently being more widely tested on women. This paper examines the differing political and ethical positions..."

Online Sources
"Do Women Need Such Big Flu Shots" by Sabra Klein and Phyllis Greenberger - NY Times Opinion Page

"In planning for the swine flu, however, public health authorities ignored the evidence that vaccines affect women more strongly than men"

There are laws (Public Law PL 103-43) mandating the inclusion of women and ethnic minorities in NIH research.

Hayden, E. (2010) 'Sex bias blights drug studies' . Nature. 464, 332-333.

"The typical patient with chronic pain is a 55-year-old woman — the typical chronic-pain study subject is an 8-week-old male mouse.

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