Sex Bias in Science: How Research Fails Women | Fertility Friday Podcast Ep. 596

Episode 596

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-M -L -I -V -E. This is the Fertility Friday podcast, episode number 596.
In today’s episode, I’m tackling a really interesting topic. This is kind of like a
follow -up to the conversation that I had with Dr. Sarah Hill. For those of you who
listened to that recent episode, you could tell that my mind was blown. And for
many years, I’ve known that women are excluded from a lot of the studies that are
done. A lot of our science, the vast majority of our science is based on the male
body and male physiology. And I also knew that the majority of animal studies that
have been done have also been done on male animals. But I feel like the
conversation I had with Dr. Sarah Hill really sparked some more specific and nuanced
details that I hadn’t really looked into. So that’s what we’re doing in today’s
episode. We’re taking a peek at how science has been done and delving a little bit
deeper into these topics. And I’m also going to be talking about how even when
women are studied and the specific goal of the study is to derive information about
women, that there’s still room for improvement in terms of those study designs. So
hold on to your hats because today’s episode is going to be really interesting.
The paper that I’m going to be going over today is called unmasking the adverse
impacts of sex bias on science and research in animal welfare. So that will be
guiding the discussion, and I’ll be bringing in a couple other interesting topics as
well. So one of the things that, one of the themes that came out in my recent
interview with Dr. Sarah Hill is just this idea that science really does need a do
-over. And it highlights, I think the big piece, for me at least, that stood out,
was just really addressing the fact that women have not really been studied well.
Although women have been studied, and obviously there are studies that do include
women and include female animals, we haven’t really been studied well, and we haven’t
really been studied as women. And what I mean by that, obviously, is that as women,
we’re not on a daily circadian rhythm cycle. We don’t have similar hormones every
single day. We have hormones that unfold over a menstrual cycle. And the average
menstrual cycle, as we know, is about 29 days. But even within that, there’s a lot
of variability. And if we look at cycle data, you can see the cycle length can
vary significantly. Hormone fluctuations can vary quite a bit as well. And so there’s
a whole lot of implications of this. And in many ways, I’ve seen this in the
research that I’ve looked at over the years, where I’m highly critical of how
they’re looking at the menstrual cycle, how they’re measuring hormones, how they’re
determining and confirming ovulation, those types of things. And I think the big
piece that I hadn’t researched, because it’s not really part of the umbrella of the
work that I’m doing, but one of the really interesting topics is how when they’re
studying drugs, they’re not studying women, or if they choose women, they’re studying
them at a specific time of the cycle. And so therefore, they’re not testing how
those drugs could be how they could interact differently with women in the pre
-ovulatory phase versus the post -ovulatory phase under the influence of estrogen or
progesterone and how that might affect how the drug function. So I think that’s the
piece that was really interesting. So this study is another review study and it’s
kind of looking at the trajectory, history, what has been done, why it’s like this.
And they make a whole lot of really useful and important points. And so when they
get into the history of it, they really do outline the historical overreliance on
male animals in the drug development process. So they’re really kind of pointing out
the fact that this is a known issue. It’s been known for a long time. And this
process that the pharmaceutical industry undergoes to test certain drugs and have them
approved has typically been done on male animals. And there’s a lot of, beyond the
obvious issue of women having higher side effects from these drugs, there’s other
practical problems that arise as well. And so since the 1930s, there has been this
kind of medical practice of excluding females and female animals because of this idea
that their cycles are too variable or that it’s adding in some sort of additional,
just something that makes it too complicated for them to study. It’s like, this is
too complicated, although that is certainly a cop -out because research is research.
they kind of go through the years and they go through that it’s been well
documented. According to the researchers, they say, and I quote, this sex bias in
biomedical research has been well documented. In a study across 10 fields of biology,
it was found that 80 % of the animals that were used were male. And it was further
found that even when both sexes were used, only one third of studies analyzed the
results by sex. So even when they include females, they’re not even separating the
data and providing how it affected one sex over the other. So it’s really
interesting how they’re doing this. It’s really shortcut research strategies here that
we’re looking at. And of course, with profound implications and profoundly negative
implications. So what we have when we look at this picture is that women are really
underrepresented in the results. And that also means that we do have a limited
knowledge. There’s a whole lot more to learn about women. And I think it gives us
an important insight because when I talk about fertility awareness and I share that
with people, when I’m interviewed on other podcasts, I had this really interesting
experience when I was interviewed for Primally Pure. I was sitting there. I flew to
California, so I was in there in their space, really nice space. Like, there was
mostly women involved in this process of bringing me there and interviewing me, but
they had their tech guy, their sound guy, their lighting guy. So there was like
five men in the room at least. And what was really interesting was that the topics
I was talking about, the questions that they were asking and the discussion that
arose. Once we finished recording, it was the men that were jumping in and like,
hey, I didn’t know about that. And I didn’t know that women aren’t even studied in
science and things like that. So that really stood out to me because while this is
information that I’ve known for a very long time, the average person doesn’t even
realize that women aren’t studied. So when we have that question of, well, why
wasn’t I taught this and why wasn’t this part of my junior high school curriculum,
right? Like, why wasn’t this addressed? I think we really need to look at this kind
of deep entrenched exclusion of female animals and women, human women in research,
and just kind of this assumption that we’re just like men and we’re just going to
study like the standard, which is a man, and we’re just going to apply that to
everybody else. And I think that that bias also then gives us an explanation as to
why the menstrual cycle, the female body, fertility, all of those kinds of topics
aren’t really addressed because they don’t really apply to men. And so therefore,
since it’s not really part of the standard, why would it be included in the
curriculum? Now, of course, we know why it should be. But for me, it really helps
put things into a broader perspective because it is a systemic issue. And if we’re
wanting it to change, then it’s not just that women have to go into male
institutions. We often think that if you’re working with a female doctor, everything’s
going to be better, but that female doctor was trained in a male -dominated
institution that the standard, even of the studies and the testing that has laid out
the medical program has been done on men. So you’re not going to have a woman come
out different necessarily because the whole structure was built on the male body.
So we know what we’re up against. And at the end of the day, what we need to do
is just continue to deepen into this and learn about it and to talk more about
this.
of sex bias, so they’ve known about it for 20 years, the practice continued to be
pervasive in animal studies. So even though it has been identified as an issue,
it’s still pervasive. And they go on to say, in 2020, when a 10 -year follow -up
study was concluded on sex reporting, there was some evidence of improvement, but sex
bias remained pervasive. There was an increase in the proportion of studies that
included both sexes, but no change in the proportion of studies that included data
analyzed by sex. So what they’re saying is, even though they’re including females
more, they’re still not analyzing the data by sex and they’re still doing certain
practices that are making it really hard to really truly study the true differences
in sex. So we’ve made some progress, but certainly not enough. So another aspect of
this is something that Sarah, Dr. Hill touched on in our interview, which is how
they actually do the research. And again, this was fascinating. So it’s like, oh, we
have to include women now. This is part of what we need to do. So let’s just take
these female, you know, animals and just take their ovaries out. And then we’ll just
study them. And so that is wild that they do that because obviously that defeats
the whole point of testing sex differences. So it is important to realize that that
is what they have been doing for many years. And when they then include actual
women. They can’t do that, but they can then study, they have chosen to include
women, but they’ll include them during the first nine days of the cycle when there’s
the least interaction of estrogen and progesterone. So again, we’re still not
addressing it. So I think that is really interesting as well. So there was a couple
of things that the researchers said that I found really interesting. So these
researchers were taking the perspective from, in my opinion, based on reading the
paper, that they’re saying, okay, they’re excluding women because they’re saying that
it’s going to cause too much variability. But one of the things that they were
saying was that even when women are included, there’s not necessarily that much
variability. There was a couple of quotes that I found really interesting. One was
that they can certainly incorporate the cycle and the hormone variation into the
design, which we’ll talk a little bit more about. But they said something
interesting. they said empirical research or
considered. So that, to me, is interesting because I wonder how they came to that
conclusion. Like, it doesn’t really matter in a lot of cases. So I think that
that’s an interesting perspective because they’re saying, okay, so maybe in certain
situations, they don’t need to consider the cycle. They can just test women or
female animals. And in other studies, they can incorporate the cycle into the design.
And I think that the reason that that struck me as interesting is because until you
actually test drug interactions when estrogen is high and progesterone is high or
otherwise throughout the cycle, I don’t know that you could really say that it’s not
relevant. So that was just an interesting piece of information that I thought I
would pull out of there.
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Now let’s go ahead and jump back into today’s episode.
So this really made me think. So there was a study that I talked about in the
summer, and I shared an episode, and it was on PMDD. And in that study,
essentially, the researchers determined, if you read through the whole study and you
kind of look at their rationale. They tested certain things. They tested the hormone
progesterone in the luteal phase, and they compared women with PMDD versus the
control group, which did not have PMDD. And the researchers concluded that because
the progester levels were not statistically significantly different between the PMDD
group and the control group, that progesterone was probably not the issue. And they
hypothesized that maybe it’s just that the women are more sensitive. Like the women
with PMDD, because the levels aren’t different, according to them, maybe the women
just aren’t as sensitive to progesterone. The reason that I find that to be
interesting is because when you look at the study design, they tested the women
once. So one day in the ludial phase. And it was mid -ludial. And so based on my
perspective of working with women over many years, looking at the menstrual cycle
chart, when a woman has issues with progesterone, it’s not necessarily mid -ludial.
That’s going to show up in the chart. So for anyone who’s not as familiar with
this, if we look at the menstrual cycle, you have your period and then you ovulate.
And then in a healthy cycle, 12 to 14 days after ovulation is going to be when
the next period comes if you’re not pregnant. And so mid -ludial would be about a
week, let’s say, seven days after ovulation. But women who have PMS and PMDD
symptoms, those typically are exacerbated during the week before her period. And so
when a woman is charting, she could have a kind of normal looking first half of
that luteal phase, but then the progesterone can drop off after that. And I would
argue that the biggest difference that you would see, if you’re dealing with women
who have PMS or PMDD versus the control group, wouldn’t necessarily be mid -ludial.
It would be during the week before their period. And that even would be dependent
on how, like, one of the signs of low progesterone is how long the luteal phase is
at all. So I said 12 to 14 days is healthy. Well, some women have like a 10 -day
or 9 -day luteal, and that would certainly indicate that their progesterone isn’t
strong enough to even give them the full length of their ludio phase. So that in
of itself is an indication that the progesterine levels are low. So if I go back
to the study, they were saying, well, the levels aren’t different. And I’m asking,
well, your study design doesn’t allow you to fully evaluate if the levels are
actually different because you only did one test on one day at the time of the
cycle when it wouldn’t really be the best time to test that because the differences
would show up in the latter part of the cycle. So I guess what I’m getting at
with this point is that even in research that is specifically to do with women. So
even when they’re studying women only to try to find results, I would go so far to
say that they’re not necessarily taking the cycle as much into consideration as they
should in many studies. And this is something that Lily and I talked about a lot
when we were looking at different research because I would be looking at the study
design and, Well, how are they testing? How are they confirming ovulation? Are they
doing it based on the day? Are they just spot testing these women and things like
that? There are certain practical implications when you’re looking at things like this
because in order to truly test women based on what I’m saying and to truly
incorporate the menstrual cycle and the hormonal fluctuations, it would be a more
complicated design. The participants would have to be more involved. They would
potentially have to come multiple times throughout the pre -ovulatory and post
-ovulatory phase. I would argue that in some cases, it wouldn’t be sufficient just to
test once and do a spot test on a certain day. They might have to have the women
actually track their cycles and chart, confirm ovulation, and come not based on a
date, day 21 of the cycle, but based on the actual date this many days after
ovulation were come in for a series of tests. So I just wanted to put that in
there as well, because I feel like even in studies currently that are being done on
women to study events in women, there’s still room for improvement in the study
design to actually get the results that we are curious about. And the reason why I
thought of that PMDD study is because that topic came up in our fan group. One of
our participants was like, I heard your podcast. And I was like, I was curious as
to why the researchers were saying that the hormones aren’t the issue that instead
it’s just these women are more sensitive and so my response was well I don’t know
that’s what they came to that was the conclusion based on their data but I would
love to see a study where they are actually testing and doing more of a series of
progesterone testing and then comparing that series of tests amongst the different
women because otherwise are you really getting a true value and it could be that
the women with MDD are just more sensitive to the hormones. But how do you come to
that conclusion if you haven’t fully tested the hypothesis by truly looking at those
levels and seeing if they’re the same? So what’s interesting then is how the
researchers decided to approach, like what were their recommendations? So they’re
outlining this problem. They’re talking about the history. They’re saying it’s been
like this for decades. And since the 30s, they’ve been doing research this way.
So what are their recommendations? So, I mean, I think the most basic is that they
are recommending that they include both sexes. Like imagine that. And for that just
to be the norm. And they are also encouraging the researchers to report sex -specific
results because one of the issues they identified was that even when they include
female animals or women in these studies, they’re not necessarily dividing the results
and showing if there are any differences based on sex. I mean, again, like basic. I
feel like we’re in kindergarten here. And they identify some of the practices that
they have about taking out the ovaries of the animals saying they should stop doing
that because obviously if you do that, you’re not really testing, you’re not getting
actual results that are useful. You’re just making it easier for yourself by trying
to reduce variables. I think that one of the things that they talked about too is
kind of reframing it differently, having one group of the male animals and then two
groups of the female animals where one of the groups is in like the pre -ovulatory
phase and one of the groups is in the post -ovulatory phase to actually be able to
test. And I think that part of the resistance to that is that it would really
change how we look at research and look at studies. It would be more expensive. It
would be more complicated if we’re dealing with human women. It may be more
difficult to find participants who are able to commit to more frequent testing or
things like that. But ultimately, I think that the paradigm has to change. They
would have to embrace the cycles. So instead of avoiding hormones and considering
them to be inconvenient, they would have to actually look at that as an important
factor to be taken into consideration. So they would actually have to kind of change
how they’re looking at it. And as I mentioned, they would have to, I believe they
would have to actually test during the times when the hormones are high. And it
could be really helpful to have a good understanding of how the cycle works and
have charting to be part of the process just so that you’re making sure that you’re
testing. And again, the reason why this is a problem in these animal testing and
drug testing is because what’s happening is they’re not testing these products when
the women actually have hormones or when the animals are actually having their
hormone levels at the highest points. And So therefore, they’re not seeing if there
are any drug interactions, and they’re not accounting for that. And so when drugs
are coming on the market, there are women are having all these side effects that
they didn’t see in the animal studies, but that’s because they didn’t test them at
these different times of their cycles. And one of the interesting aspects that kind
of came out of this study was the implications for animal welfare. So that wasn’t
something I was expecting to see. But by not testing female animals, they end up
sacrificing a lot of them and having what they would call animal waste. So even
from an animal welfare standpoint, I mean, I’m not even getting into the should they
be testing on animals conversation, but I’m just saying that by not including female
animals, there’s a lot of female animals that are discarded because they’re not even
needed because they’re not looking at them. So that was also an interesting piece
that came out in the study. So, I mean, to wrap it up, I hope that this episode
has been enlightening for you just to really explore this topic a little bit more,
go a little bit deeper into it, and think about the implications. There’s certainly
implications in the interesting world that we live in with all the different
pharmaceutical drugs coming out that are not being actually tested. And even when
they’re being tested on women, it’s kind of like in name only, like they’re kind of
pretending to test on women, but they’re not really testing with female female
physiology, female hormones. They’re just kind of finding a way to fit female
biological creatures into these studies without really exploring any of the variables
that make them female in terms of the hormonal interclay. So that’s huge and that’s
really helpful to know. On a practical standpoint, from a practical level, it is
helpful to know then that even when we’re looking at if you’ve been put on certain
medication or things like that, they may not have data. You may actually experienced
side effects that aren’t even listed because it wasn’t even tested and studied. So
that’s terrifying. That’s a whole other level and a whole other layer that we would
have to be thinking about. But I think it is knowledge is power. So it’s helpful
to be aware of those things. But in addition to that, even studies that are looking
at women. So while I love research, obviously, I’ve been doing this research series
for years now. I use a ridiculous number of citations in my books. I love to
review research and actually provide evidence -based information. That’s one of the
draws for many of our fan practitioners in our programs. They love the depth of
research that we go into and all the studies that we provide to back up all of
our different recommendations. But with that said, we have to have a discerning eye.
We have to be able to look at research not as gospel, but as what it is. We have
to understand that there are researchers bias, And we need to be able to look at
the study designs to critically think about how they have been, what the researchers,
how they designed it, why they did it this way, and what the potential limitations
are for designing studies a certain way. Now, as someone who’s not actively a
researcher designing studies, I do have some empathy for these researchers because
obviously this is a more complicated design. It involves certainly a lot more, Like
I said, if you’re designing a study this way, the participants would likely have to
come in more frequently. It would likely be more expensive. You’d likely have to
have a larger cohort of women. And from a practical standpoint, it might not always
work. But I don’t need perfection. And I don’t think any of us need perfection. I
feel like we need progress. And so the more that we can, interestingly, this
particular study, the researchers are calling for change. So I think that is also
really exciting. I think that this topic is going to be in the forefront a lot
more. And just to give a nod to Dr. Sarah Hill for bringing this even more to the
forefront. I know she’s going to be out there really inspiring other researchers to
look at this. I do think that it’s going to shift. I don’t think it’s going to be
overnight. But I think the more that we can talk about it, learn about it,
understand female physiology, and of course, understanding how the cycle works so that
we can actually start to test it accurately, I think really and truly will only
benefit from that level of research. So with that said, if you wanted to take a
peek at the studies that I mentioned in today’s episode, you’ll find it over at
fertility friday .com slash 596. If this episode, if you can think of somebody who
would really benefit from hearing it, if you have a friend or a colleague or a
client who comes to mind, then I would highly you to share again fertility friday
.com slash 596. And if you have been enjoying the episode,
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With that said, I’d like to wrap up here. I hope you have a wonderful week weekend
whenever you tune into the show. And of course, as always, until next time, be well
and happy charting.
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