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Playing Catch-Up in Gender Health Research

SHOULD PLAYING CATCH-UP BENEFIT MEN AND WOMEN ALIKE?

It has been often alleged that women were shortchanged by medical research. For example, a 1993 editorial in The New England Journal of Medicine made this categorical assertion: "There is little doubt that women have been systematically excluded as subjects for study . . . it is not surprising that most clinical trials have been heavily, if not exclusively, weighted toward men" (1). A 1999 fact sheet from the National Institute of Mental Health stated, "Historically, research studies were conducted only with men."

It is now clear that the claim of the routine exclusion of women is not consistent with the facts: As early as 1979, women participated in 96% of all clinical trials sponsored by the NIH (2). An analysis of enrollees in one of the major trials sponsored by the National Cancer Institute found that women represented 57% of all participants in 1989 (3). Meinert and colleagues reviewed all clinical trials published in five leading medical journals in the years 1985, 1990, and 1995. Overall, there were 550,743 women and 355,624 men enrolled in these trials (4).

An article that appears in the September 2001 issue of Epidemiology gives further evidence of sex-specific participation in clinical trials (5). I did a Medline search for clinical trials published in the period 1966-1990, identifying the number of sex-specific "hits" for each of 12 important health conditions:

Sex-Specific Analysis of Clinical Trials, 1966-1990

Male Female AIDS 20 12 Arthritis 19 22 Cancer 14 194 COPD 16 15 Diabetes 25 20 Heart Disease 137 78 Flu 7 4 Injuries 18 22 Mental health 29 27 Reproduction 20 139 Sex Hormones 2 (Testosterone) 25 (Estrogen) Stroke 22 19 TOTAL 456 577

It can be seen that a similar number of clinical trials on arthritis, COPD, injuries, mental health, and stroke included men and women. In the areas of AIDS, diabetes, heart disease, and flu, more trials included men. And in the areas of cancer, reproduction, and sex hormones, more studies included women. Overall, the total number of clinical trials favored women by a 26.5% margin.

Although it appears that women were underrepresented in heart disease research (6), it is clear that men were underrepresented in other important areas of medical research.

The perception that women were commonly excluded from medical research, and the belief that health research needed to play "catch-up" for this fact, has formed the basis for much of gender health policy over the past decade. The number of female-only studies grew to outpace the number of male-only studies by a three to one margin in 1997 (7). Asa result, overall male participation in NIH extramural research fell to only 32.2% in 1997 (8).

If we are going to play "catch-up" in the area of heart disease research for women, why aren't we helping men's health research compensate for past underrepresentation in the areas of cancer, reproduction, and sex hormones?

References: 1. Angell M. Caring for women's health---What is the problem? N Engl J Med 1993 329: 271-272. 2. Dickersin K, Min Y. NIH clinical trials and publication bias. Online J Current Clin Trials. Doc. 50. Vol. 2, April 28, 1993. 3. Ungerleider RS, Friedman MA: Sex, trials, and datatapes. J National Cancer Institute 1991; 83: 16-17. 4. Meinert CL, Gilpin AK, Unalp A, et al. Gender representation in trials. Controlled Clin Trials 2000; 21: 462-475. 5. Bartlett EE. Gender participation in medical research: An examination of the evidence. Epidemiology 2001. 6. Lee PY, Alexander KP, Hammill BG et al. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA 2001; 286: 708-713. 7. General Accounting Office: Women's Health. GAO/HEHS-00-96, May 2000. 8. National Institutes of Health. Implementation of the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, September 1, 2000.

[Links: The New England Journal of Medicine http://content.nejm.org/ The Journal of the American Medical Association http://jama.ama-assn.org/ The National Institute of Health http://www.nih.gov/ The National Institute of Mental Health http://www.nimh.nih.gov/ The General Accounting Office http://www.gao.gov/ Epidemiology http://www.epidem.com/ ]

 

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