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Ask the Mental Health Expert Archives 2001-2004

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Females as Test Subjects

Q. Why is so little of the pharmaceutical research done on women? Do you think this is likely to change? What special considerations must we as doctors have when treating our female patients?

A. I suspect that the lack of research involving female subjects stems from a combination of male-oriented bias, legitimate health concerns, the wish to simplify issues of drug metabolism, and perhaps some fears about potential litigation. Ours is not the only country in which medical research focuses more on males. A study done in Sweden (M. Soderstrom, Lakartidningen 2001 98:1524-8) found a similar pattern there, rationalized in part by "concern not to harm women of childbearing age" and the wish to "repeat studies on former study populations that happened to be composed of men."

Thus, in theory, if a scientist wants to replicate a drug study done twenty years ago, he (or she!) would need to select a study population with the same sex distribution. According to one report (MJ Berg, J Am Pharm Assoc Jan-Feb 1997), the situation is slowly changing, with the federal government now undertaking a long-range study of disorders affecting women--the Women's Health Initiative. There are, to be sure, psychiatric disorders or conditions that uniquely or preferentially affect women. Unipolar major depression, for example, is about twice as prevalent among women as men--but the rate in women is the same as that for men before puberty and after menopause, indicating that it is the years in the middle that put women at higher risk.

In fact, contrary to the old notion of involutional melancholia, menopause per se not a major risk factor for depression; however, the peri-menopause (5-7 years prior to menopause) does increase depressive risk in women. It may be that fluctuations in estrogen (associated with perimenopause) may be more critical than static low levels seen in menopause (see Sano & Salloway, Psychiatric Times, Dec. 1999; Stahl S, J Clin Psychiatry, supplement 4, 1998). This, of course, opens up the whole question of estrogen replacement therapy for depression in perimenopausal women--a subject on which there are few well-controlled studies.

A good review of these issues is found in Altshuler et al, Journal of Psychiatric Practice, May 2001. It does seem likely that metabolic and pharmacokinetic differences between men and women are relevant to some psychotropic medications, perhaps those metabolized primarily by the cytochrome 3A4 system--though not all studies support this claim. (For a full discussion, see Women's Mental Health, by Vivien Burt & Victoria Hendrick, American Psychiatric Press, 1997; and Gorski et al, Clin Pharmacol Ther 2000; 68:412-7.)

Some recent research also suggests that women with major depression may respond preferentially to serotonergic (rather than noradrenergic) antidepressants. All physicians should also be aware that some endocrine conditions, such as thyroid dysfunction, are much more common in women. As doctors, we also need to be sensitive to psychosocial factors that may increase the risk of depression in women, such as the absence of close interpersonal ties; marital discord and separation; and absence of employment outside the home. Even if the menopause per se is not associated with increased rates of major depression, it may still be a difficult and stressful time for many women.

Then, of course, there is the whole territory of PMS and related conditions; and the eating disorders, which are much more prevalent in women. A much fuller discussion of these issues is found in the book, Women's Mental Health (Burt & Hendrick). And let's all hope that research on women's issues continues apace.

September 2001

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