http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/womct_femec_e.html

A lot of countries probably have similar policies, so it’s definitely something there’s awareness about.

‘In the United States, the drive for dedicated women’s health research came from public policy and grassroots activists.11 In response, the NIH established the Office of Research on Women’s Health (ORWH) within the Office of the NIH Director in 1990.12,13 The ORWH advises the NIH Director and staff on women’s health research matters; ensures that NIH-supported research adequately addresses women’s health issues; ensures that women are appropriately represented in biomedical or behavioural research; and, develops opportunities for and supports the involvement and advancement of women in biomedical careers. Other agencies within the US Department of Health and Human Services address aspects of women’s health that fall within their mission, including healthcare services, drug regulation, or health policy.14′

Link:http://www.mja.com.au/public/issues/178_12_160603/pin10261_fm.html#Box1

So you’re right on that in your initial post; it hasn’t been looked into for very long (in the US, at least).

As a scientist, I simply don’t share your faith in the ability of science to solve any problem that may arise. But it depends on the time-scales, I guess. A hundred years from now, most problems we know of today will probably have been solved. 10 years from now? I don’t think so.

And we keep coming back to the same problem, here– if we’re doing studies that specifically exclude women, how can we then give the tested drugs/procedures/medical care to women? If women are so different that we can’t do clinical trials, how can we possibly assume that they’re not different enough from men to have different reactions in a real-world setting?

Of course you’re entitled to your opinion and everything, and maybe someone will come along here and make an argument that blows mine out of the water, but for now, I absolutely refuse to believe that these problems can’t be solved, and that they shouldn’t have been already.

In principle it might be possible to track each participant beforehand. However, depending on the study one could imagine that it would require each of them to report for sampling several times a week for months prior to the start, in order to chart the natural variability in each woman for whatever parameter was being measured.

This is of course absolutely no guarantee that the same variability will be present when the experiment actually starts, so that would be problem number 1.

Problem number 2 would be to have the participants (several thousands perhaps?) actually showing up for some time (weeks?, months?) beforehand to get sampled – spending their lunchbreaks/evenings/weekends as guinea pigs…

Problem number 3 would be to make sure that all participating women ‘behaved’ in the same way during the experiment as in the ‘tracking period’: Don’t get pregnant; if you are pregnant, don’t have an abortion; don’t gain weight; don’t loose weight; don’t start exercising; don’t stop exercising; don’t change your amount of exercise; fill in more on your own.

OK, I’m waaaay out of my league here. As stated in my first comment I’m a geoscientist so I’m in some sense making these medical examples up as I go along. That doesn’t mean it couldn’t happen. What I’ve written above are issues that I could see show up, and which I’m having a real hard time seeing how you can properly control for in a clinical experiment. And, as stated in my first comment: I’ve known female researchers who excluded women from their experiments because they didn’t know how to properly control for their natural cycles. That’s all I originally was going to say…

There must be some real medical researchers reading Cara’s blog that can provide us with some real-world examples of why women (in some cases) are excluded from medical trials? Help? Please?

In that case, one could imagine a project investigating the influence of different types of diets on the levels of certain hormones in the participants. If the experiment included a large number of women, all at various stages in their cycle (thus different levels of hormones) it could be immensely difficult to separate this natural signal from the signal related to the change in diet imposed on the participants. In other words, the effect of change in diet (if existing) can not be established with any certainty.

disclaimer: I am not now, nor have ever been a scientist. A friend of mine who did a BSc while I was doing my BA laughs at me when scientific anything comes up.

I may have misunderstood, as I seem to be missing something: why do the influence of women’s cycles have to be separated from the results of medical testing? They will still have cycles when the pill/procedure is ‘out on the market’ instead of in testing, whatever influence they each have is still going to be there. (Granted, different influences for different women wiht different cycles and at different stages in life, but still.)