Sex really does matter

Does legislation really make a difference to the health of women? A quarter of a century ago, the USA legislated in the Women’s Health Equity Act to remove the inequalities between men and women in medical research. More recently, Health Canada recommended comparative studies in healthy male and/or female volunteers to minimize variability. Nonetheless, nothing has really changed.

More than 50 drugs act differently in women.

Apart from gender specific diseases, such as gynaecological problems, women are still underrepresented in research studies – both as researchers and as drug trial participants. A recent systematic review identified more than 50 drugs that act differently in women than in men, yet women remain an afterthought in treatment development.

This persistent disparity means there is no evidence to explain why men and women respond differently to many drugs., The literature, however, abounds with postulations. One possible explanation is that women produce less stomach acid and therefore food stays in their stomachs longer than in men. If correct, women should wait longer than men to take medications that need to be taken on an empty stomach. Excretion rates for drugs may also differ due to different functioning of the kidneys and the liver in women and men.

As a result of greater overall body fat in women, there is more activity of drugs that bind to fat and less activity of drugs activated by water. This may be particularly important in the control of blood pressure and heart failure in women. In clinical trials, for example for heart failure, higher rates of adverse drug events continue to be reported in women.

Before the menopause, women also show a different immune system profile than men, this could contribute to the high incidence of chronic diseases in premenopausal women.

Hopefully, as more women are represented in policy-making bodies, more steps will be taken to improve the management of non gynaecologic health problems in women. These steps should include: increased funding for studies that will explore the reasons for the differences in recruitment of women to clinical trials and treatment strategies between genders; education of physicians regarding the different effects of drugs on women; and incentives to improve reaching treatment goals for women.

If the past is prologue, significant change may be more decades away. The European Medicines Agency still explicitly promotes that research participants can be of either sex.

It will, of course, come faster if women and enlightened men advocate for research that redresses the gender imbalance.

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