A couple of stories about recent studies regarding women’s health have piqued my interest. The first is about the emerging suspicion that common heart treatments that work for men are likely to be deadly for women.

Research presented at the annual European Society of Cardiology meeting in Vienna suggested that surgeries which typically save men’s lives can be deadly for women.

A small study of 184 women conducted by Dr. Eva Swahn of the department of cardiology at University Hospital in Linkoping, Sweden, found that women who had major heart operations like a coronary bypass were more likely than men to die.

. . . [I]n Swahn’s study, as in two previous Scandinavian trials that looked at hundreds of women, experts found that women had a higher death rate than men when invasive heart procedures were performed.

In Swahn’s study, the women were divided into two equal groups: one which had an invasive procedure like a coronary bypass surgery or an angioplasty and another that waited until further symptoms developed.

Of the women who had an invasive procedure, eight died after one year. That compares to just one death in the other group.

The second story is about how birth control pills may not be equally effective for women of all sizes.

Do birth control pills work differently depending on your weight? New studies suggest that just might be the case. Oral contraceptives come one size fits all, but several new studies suggest that there are more unplanned pregnancies for heavy women on the pill than there are for their thinner sisters. Doctor Alison Edelman studies oral contraceptives and says bigger women have less medicine in the bloodstream.

Instead of being pleased with the developments, though, I’m wondering who the hell dropped the ball so badly that it has taken until 2007 to start figuring these things out.

Heart surgery has been around for many decades, though high success rates are admittedly fairly recent. The point is that heart treatment is a dynamic area of study with constant studies and innovations taking place. And someone finally thought to ask whether women respond differently to life or death surgery than men . . . now?

And what about birth control pills? Those have been around and pretty damn similar to their current form since the 60s. New pills are constantly being developed, as are many other different kinds of hormonal treatment. And only now have they thought to include some overweight women in their studies? I have to say that I have a huge problem with this article, because there’s absolutely no explanation of what “heavy” means. But I have to assume that the study was slightly more specific, and it seems that more are going to be done.

But seriously. It’s 2007, right? The medical community has known for a long time that male and female physiology is different. They’ve also known for a long time that weight influences many types of required drug doses. And yet, here we are.

Let me say that, yes, I am grateful towards those who are doing the research now.  But I’m absolutely maddened by the idea that these things are unknown, when ample time has existed to do the research.

There’s no way in which the heart treatment issue does not scream sexism and male bias. We all sadly know how greatly men outnumber women in medical fields. And there’s no denying that men’s bodies have historically been treated as the default. If it works for men, it must work for women, too, and if it doesn’t, they’ll just act shocked and figure it out later.

But what about the contraceptive issue? Is it one of sexism and ignoring women’s medical need when men’s would be considered? Or is it simply a sign of pharmaceutical greed, because there’s a lot more money in developing new contraceptives than studying the effects of the current ones? I don’t know enough to say, but my gut reaction is that there’s a combination effect.

Either way, it makes me wonder who the hell is really looking out for us.


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16 Comments so far

  1. newslang on September 4, 2007 12:24 pm

    This, while surprising seems pretty reasonable to me in a way. I mean, the medical field goes out of its way not to include women in medical trials. Why? because they consider us to be constantly pregnant. Women are excluded because there’s always the possibility that they’re pregnant and so to protect this maybe-there maybe-not-there embryo women who are considered to be fertile are just not included. So, in a society where women aren’t in clinical trials, of course we won’t know the effects on women until it’s released to the public, and even then not so much because it’s no longer being scrutinized to find side effects and such.

    And I could be wrong, but weren’t female birth control pills only medically tested for like a year? and not even in the US? I mean they’ve been working on that man-pill for oh what now? 10 years? The medical community will do anything to make sure no pill will ever harm men. Women? ehhh, they don’t really care about us.

  2. Ole on September 4, 2007 12:32 pm

    Cara, relax. Did you think about these issues until you read about them, despite the fact that you have known about the existence of heart surgery and birth control pills for a long time?

    From my own research* I know that just because a scientist works within a certain area of speciality does absolutely not guarantee that hers/his idea of what would be logical to study is the same as that of the general public – or fellow scientists.

    I’ve had one experience where I removed myself ever so slightly from my own speciality, partly moved into a borderline research area and suddenly realised that what I had been doing as routine for some time was brand-new ideas and concepts in that area and had some cool implications. When you are deeply embedded in a particular field you sometimes loose track of the obvious.

    Also, there is a chance that some of these results may already have been reported decades ago, but in an obscure place and so forgotten. Have you checked that?

    The influence of weight on the effectiveness on birth control pills: Women have gradually become heavier since the introduction of the pill in the 60’s so one could imagine that this effect could go unnoticed for quite some time, if the only thing that is monitored on a frequent basis for a pill is its overall failure rate.

    Finally, with respect to your ’sexism and male bias’ statement I’d like to point out that I’ve had female friends working in food and nutrition science who frankly stated that they’d always use males for their experiments.

    The reason? Womens natural cycles messed up parts of their experimental results and it was a lot easier to get reproducible results using males for their experiments.

    They were obviously fully aware that this was unfortunate but at the time they didn’t have a solution to control for it. Don’t know if it has been worked out by now, maybe it has.

    *Disclaimer: I’m a geo-scientist so I have no knowledge about medical science whatsoever, only the scientific method.

  3. Cara on September 4, 2007 12:45 pm

    Well Ole, the reason why I haven’t considered these things previously is because I don’t spend a lot of my time thinking about medical research. I can say, though, that I have definitely thought about differences in treatment for men and women in other areas, because it comes up and it’s not really anything new. And yes, I had kind of assumed by this point that if there were differences in major areas like cardiactic health they were already determined or vigorously being researched.

    I think that is a testament to my often blind faith in medicine and doctors. I’m working on that one.

    As for weight, yes, women have gotten heavier since the 60s. But overweight and obese women still existed then, and weights have been increasing for some time. Shouldn’t the effect of increasing weight have been looked at in, oh, I don’t know maybe the 80s?

    As for not using women in studies, your comments only increase my conviction that women are being unfairly ignored. I don’t find women’s cycles to be a valid excuse for exluding them– I find it to be a flaw in current male-based systems of data-gathering and research. It seems to me to be yet another example of men being perceived as the “default,” and since we can’t find a way to include women in that model, we just leave them out. What about a new model specifically designed for women, like this one seems to be designed for men? Or working on a system that delivers credible results from both sexes, instead of just assuming that women’s bodies are the problem?

  4. Ole on September 4, 2007 1:48 pm

    Yeah, maybe the weight issue should have been looked into in the 80s, but what if nobody thought about it? Don’t assume that all scientists are always thinking about everything. While it is obviously flattering for us it’s simply not always the case that we see what is right in front of our noses because we – sometimes – think that the solution is far more complex than it is.

    I agree that women’s cycles can not be used as an excuse for leaving them out. But again, what if nobody has figured out a way to separate the influence of that on the results? It’s really not always a given that just because we can see where there is a flaw or a problem, we also know how to work around or fix it.

    I don’t have any examples from medical research to illustrate this, but a cool (to me) problem is that as of 2007 nobody – nobody – knows how we would be able to safely land human beings on Mars, despite the fact that talks of a manned Mars mission have been going on for decades (http://www.universetoday.com/2007/07/17/the-mars-landing-approach-getting-large-payloads-to-the-surface-of-the-red-planet/).

    I know that’s way off topic, but it’s just to illustrate that problems can not always be solved even though we’d like to.

  5. Anorak on September 4, 2007 7:02 pm

    Cara, just a little anecdote on this topic.
    I used to be on the Pill and gained some weight during that time (correlation?). When I got to 68 kg (sorry I’m not good with pounds, I think that’s around 150-160?), my doctor told me that if/when I hit 70kg or above, I would need to start taking a double dose i.e. two pills a day.
    I never hit the 70kg mark, so never had to take a double dose.
    It kind of freaked me out to think of doubling the amount of hormone I was taking because of a few kilos.

  6. Cara on September 4, 2007 7:18 pm

    Wow. That’s odd. Especially since I weigh over 68kg! Eep!

    It definitely makes sense to met hat different gradients of hormones might be needed for different weights. But doubling it for being slightly overweight? That can’t be right.

  7. melanie on September 5, 2007 11:34 am

    Ole –

    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.)

  8. Anorak on September 5, 2007 10:38 pm

    Yeah, well I guess they couldn’t give me 1 and 1/3 of a Pill or whatever it worked out at.
    I remember the doctor saying that it was fairly new research that had shown this to be the weight that the Pill started to be less effective, and we both (the doctor and I) bitched at the time that 70kg wasn’t very heavy, considering many adult women probably weigh around that, give or take a few kilos, and many women weigh a fair bit more than that…
    IBTP for unrealistic weight expectations for women!

  9. Ole on September 6, 2007 12:42 pm

    Melanie, this was way back in the early or mid 90s and I can’t remember the details about the research project that my friend told me about. However, the project in question was not in anyway related to the pill or any other type of contraceptive; it dealt with the influence of some special types of food or nutrition or diet on the participants, just to be clear on that.

    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.

  10. Cara on September 6, 2007 1:25 pm

    But why can’t they just track each participant beforehand and then look at the changes? Don’t they have to do a comparative study to get accurate results, anyway?

  11. Ole on September 6, 2007 2:52 pm

    I was kind of hoping not to be asked that ;-)

    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?

  12. Cara on September 6, 2007 2:59 pm

    As for your problem #3, men experience a lot of those same issues. Sure, they can’t get pregnant, but they can change their habits, lose/gain weight, etc. It’s nothing new to assume that participants are not going to be idealized guinea pigs through a research process.

    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.

  13. Ole on September 6, 2007 4:03 pm

    All I was saying initially was that I knew of at least one case – via my friends who carried it out – where they didn’t know how to control for women’s natural cycles and therefore excluded them. I was *not* implying that it shouldn’t be attempted to solve that kind of problems.

    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.

  14. Ole on September 6, 2007 4:58 pm

    In the US, research on women’s health apparently didn’t become organized until around 1990:

    ‘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).

  15. Ole on September 7, 2007 7:11 am

    I’ve trying to post this several times, but somehow it bounces. Hope this works.
    Anyway, here’s a link to Canada’s policy ‘…to ensure that women are enrolled in clinical trials at all stages of drug development…’:

    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.

  16. Ole on September 7, 2007 7:12 am

    But then there’s also this:
    ‘BARRIERS TO FULL PARTICIPATION OF WOMEN IN CLINICAL TRIALS
    Women face several types of barriers to full participation in clinical studies. Some barriers are ethical, some legal, some scientific, and some are the consequences of efforts to conserve scarce resources. These barriers result from: (1) the responsibility to protect the reproductive systems of women of childbearing potential and fetuses; (2) the fear of legal liability if a woman (or, subsequently, a child) suspects damage to a fetus or gamete due to a study; (3) the ease of recruitment, the compliance, and the condition of being at high risk for the endpoints being examined in a study cohort; (4) the availability of identifiable, convenient cohorts (e.g., veterans, army recruits); and (5) known variations in hormonal status affecting laboratory test results and inferences about treatments.19′
    From this link:
    http://books.nap.edu/openbook.php?record_id=10572&page=R1

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