You're listening to (MIS)Treated, I'm Nam Kiwanuka.
Did you know that up until 1993 women weren't included in clinical trials in the United States.
It would take Canada a few more years to include women in clinical trials in 1997.
So, I'm a music lover and I'm probably showing my age, but these were some of the biggest songs in 1993.
Sheryl Crow - "All I Wanna Do", is just have some fun.
Salt 'n' Pepa - "Whatta Man'.
Meatloaf - "I'd Do Anything For Love".
And "Insane in the Brain" from Cypress Hill.
In short, 1993 wasn't that long ago.
But that's decades of research opportunities that have been lost, and women suffer for it.
And this exclusion has had a huge impact on women's health.
So, why are clinical trials important?
They help us find new approaches to medicine, and to deepen our understanding of how to treat illnesses.
Less than 10 years ago, scientists didn't even use female mice in their research until the National Institutes of Health, in 2016, mandated that researchers include female mice in their trials.
The assumption was that, quote, "Females would respond the same way as males in drug trials."
And some researchers avoided conducting studies on female mice because their fluctuating hormones could make their test results, quote, "messy".
As a result, historical bias and the absence of research has caused a systemic lack of understanding about women's health, which has created a huge gender gap in healthcare.
Women are twice as likely to experience adverse affects from medication.
Women are less likely to receive appropriate prevention and management of heart diseases which, by the way, is the leading cause of death globally for women.
And one study found that women in 900 different disorders are diagnosed 3.7 years later than men.
So, why did it take until 1993 for women to be included in clinical trials in the US, and another four years to be included in Canada?
And what's changed since?
We'll be talking about all that and more with our guest today - Dr. Michelle Cohen.
She's a family physician and assistant professor in the Department of Family Medicine at Queen's University.
She joins me now.
♪
Dr. Michelle Cohen, welcome to the podcast.
Thank you so much.
We've been following each other over the years on social, it's the first time we're meeting in person.
So it's really nice.
Yeah, it's great, it's great.
So, today we're talking about the history of women's exclusion in clinical trials.
But before we get into that let's get back to the very basics.
What is a clinical trial?
So, a clinical trial is a very carefully monitored set of experiments that are designed to test what potential treatments will do in people.
So we can study things in a petri dish or in the lab, you can figure out how one, you know, molecule interacts with another one, but you can't ever really be sure what it's going to do in a human body because humans are so complicated.
So, clinical trials are the way that we test how a potential treatment will actually work.
Is it effective the way we want it to be?
Is it safe?
Are there problems or side effects or, you know, risks that we aren't aware about?
Mm, so they're very important in the sense of how they, uh, human beings react to them.
Yes, absolutely.
Are they just for developing drugs?
Uh, developing drugs but also procedures as well, so surgical procedures or medical devices, implants, pretty much anything that you would use as a therapeutic or any type of treatment for a condition, or even for preventative strategies as well, preventing certain diseases.
You know, you need data from a clinical trial to tell you is it worth it, is it worth the pros versus the cons or the risks versus the benefits, and is this something that we want to implement on a wide scale and offer to patients.
So, understanding their importance...
Mm-hmm?
Why then have women been historically excluded from clinical trials?
So, there's been a historical tendency to kind of ignore women anyway when it comes to developing ideas around how the body works.
Or maybe 'ignore' is not the right word, maybe it's more thinking of the male body, or the cis male body in particular, as sort of the default or the kind of human standard, normal neutral human standard.
So, when research gets done it's often... has been traditionally, and still currently, done on the sort of neutral human body standard.
And then everything is sort of extrapolated to women.
So, part of the problem is that women were seen as different or, you know, kind of a substandard form of a human body.
And also the complaint or the problem was offered, um, that women have hormones, hormonal cycles, you know, women who are menstruating are going to have their cycles change throughout the month.
There are potentially issues with pregnancy, it can change hormones even more.
Then if you have a pregnant person enrolled in a study you're dealing with two people affected by a medication or treatment instead of just one.
Complaints were offered as a way to disregard the importance of including women in trials, and just saying, "Well, you know, we can just kind of do the trials "on the standard that we've already decided "is like the default human being "and then we'll just sort of extrapolate that to women "because, you know, it doesn't matter as much."
Just listening to what you've just said, all the complexities of women's bodies, the hormones, pregnancy, all these, that sounds a lot more complicated than a default so-called human body.
Yeah, yeah, absolutely, absolutely.
So, in the interim, when you have, um... 'Cause I think for a while they also considered women to just be small men?
Yeah. (Nervous chuckling) Yeah.
Small substandard men, basically.
Just sort of a weaker, more inferior version of the male body.
Um, so just sort of a man but with, you know, a uterus and some troublesome hormones created by these troublesome ovaries.
Or there's actually a quote that's been attributed to one of the pioneers, 1800s pioneers of medicine, Rudolf Virchow, who supposedly said, "A man is a human with some testes, "and a woman is a pair of ovaries "with a human being attached."
Oh my God.
(Both laughing)
Where's the chair? I want to throw it against a wall.
Yeah, absolutely, absolutely.
So it gives you a real indication of kind of how... ..Victorian medical men conceived of women, thought of women's bodies, and this was the foundation upon which much of the modern medical system is based, the sort of theoretical basis that, you know, women are just like body parts assembled...
You start with, like, the reproductive organs and everything is kind of rearranged around that.
But this actually creates an environment where there's a lot of harm that is perpetuated by not acknowledging that women's bodies are different from male bodies.
In the 1970s, there was a push from women to be included in trials.
What was their argument then?
So, the argument then was kind of based around the Thalidomide scandal.
That Thalidomide was a drug that was used as a sedative, and for morning sickness in pregnancy, in the late '50s and early '60s.
And after a few years in use it was taken off the market because, in multiple different countries, it caused a lot of problems with birth defects and pregnancy losses, and it's not a safe drug to use in pregnancy.
So, very quickly it was removed from the market.
And in the '70s the push was... ..the push from the medical research perspective was we just can't include women in at least early clinical trials at all.
Can't include women of reproductive age.
Or I think the phrasing was, you know, "potential for pregnancy", "childbearing potential".
Which basically means anyone who's menstruating.
It's a huge, huge range in age, you know.
So if there's a potential that you could get pregnant then you should be excluded from these studies because potentially that could affect the pregnancy.
Which sounds like a reasonable thing.
But then, what does that create?
So, you can't just remove a whole chunk of human beings from a set of studies. You know?
It really limits what we learn about women's bodies.
It perpetuates this idea of women's bodies as being special, different, mysterious, controlled by hormones, controlled by reproductive organs.
Primarily for the purpose of pregnancy.
You know, even women who are single, or in a relationship where they're not going to get pregnant, or on birth control.
Husbands who have had vasectomies.
Husbands who have had a vasectomy.
You know, with a partner who's not going to get you pregnant, or just not with a partner at all and maybe you've had your tubes tied.
Whatever, there are lots of situations where someone could say, "Hey, my risk of pregnancy is super, super low, "or basically zero" but because of the child-bearing potential, you know, that model would still see them removed from clinical studies.
So, you know, on the one hand, yeah, we want to be careful when we enrol someone who could potentially become pregnant or is pregnant in a study, but that doesn't mean that we should be excluding a major group of the population.
And also pregnant people do deserve to have evidence-based care as well.
So, even the framing that pregnant people shouldn't be involved in clinical studies alone is kind of problematic, because really we should be looking to collect evidence on all types of bodies, on all groups of people.
It should be just a part of scientific pursuit to be interested in things that we don't know, and trying to get more information about things we don't know.
And likewise with medicine.
We should be trying to provide the best evidence-based care that we can.
And we can't do that if we just eliminate a group of people from clinical trials, or at least from the early stages of clinical trials.
So that was kind of the framing in the late '70s that, okay, we just have to exclude everyone who could theoretically potentially become pregnant because, you know, they're just too special a category and we want to protect potential pregnancy.
Mm.
Well, this thing, the next thing that I'm going to say just kind of blew my mind when I found this out.
In the 1970s, the first clinical studies on the effects of oestrogen, the sex hormone responsible for female physical features and reproduction, were done on men.
Yeah, yeah.
(Laughing)
Uh, say what now?
Yeah. I know, it's pretty ridiculous.
Um, and it's hard to hear that stat and not to have, like, an emotional reaction.
Keeping in mind that clinical trials did not begin and end in the 1970s.
And we're talking about from--
What we're talking about is from the time from the first recorded trials in 500 BC to right now.
What has been the long-term harm caused by women's exclusion from clinical trials?
So, we know less about diseases and how they affect women's bodies.
We know less about treatments.
We know less about, you know, efficacy, drug dosing, appropriate dosing, risks of certain treatments.
We're just providing an entire group of people, really half the population, substandard therapy because we just don't know enough about it.
There are also some conditions that primarily or predominantly affect women, and if we don't enrol women in clinical trials we're just deciding that those diseases just don't matter.
So there's a saying I think about sometimes, uh, "You measure what you treasure."
Mmm.
It's really a reflection of how we do medical research and how it reflects our priorities, or how it speaks to our priorities. You know?
You know?
If you're not measuring a disease that predominantly affects women, or predominantly affects certain racialized groups, you're basically just saying, "Well, that disease doesn't matter.
"We just don't care about that population.
"We just don't care about improving their quality of life, "or lengthening their lifespan."
Or acknowledging their pain.
Acknowledging their pain, absolutely, providing effective treatment, making people feel better.
You know, just decided, "Well, we're not going to look into it "so that group just doesn't really matter to us."
So it's a reflection of our priorities as a society on the whole.
Um, I don't know if you're a fan of Nicole Kidman, I am a fan.
I will watch anything that Nicole Kidman is in.
But do you remember that show, I think it's called Big Little Lies?
I didn't see it, but I remember.
So, I've been rewatching it 'cause my nervous system, I just want to rewatch things that I already know the endings too.
(Both laughing)
And in it there's a storyline where she takes a sleeping aid.
Mm-hmm.
And she doesn't understand why she ended up, like, driving, and in the middle of the woods in an accident.
It keeps happening.
Mm-hmm.
And there was a sleeping aid that the dose was only tested on men, so when women took it they actually did end up in accidents.
And that just kind of blew my mind that something that can potentially put you in a situation where you could die is just like, "Oh, well, you know, just give them the same dose."
Yeah, exactly.
Oh, well, you know, at least we protected the child-bearing potential of these women in our studies.
You know?
Absolutely, absolutely.
It's pretty ridiculous.
Yes.
But it's absolutely the kind of thing that happens.
We diagnose certain diseases less, you know.
The example of heart attacks in women is a really good one, it's been used a lot, and discussed a lot by cardiologists and female cardiologists in particular, that we...
..there was around the mid-20th century this big explosion in research around heart attacks.
And a big concern for men, middle-aged men, dropping like flies, they're having all these heart attacks in the prime of their life and they're being cut down by heart attacks.
And so there was a lot of effort put into research and treatment around heart attacks, which is definitely really important.
And we've improved survivability, we've improved prevention when it comes to heart disease.
But we still are focusing primarily on the male population and we are ignoring the fact that women also have heart attacks in pretty large numbers.
It's still a major contributor to mortality and morbidity for women.
And yet, when women have chest pain, or the type of chest pain, or heart attack symptoms, that's often classified as atypical symptoms, or atypical presentation of a heart attack.
Treatments are not tested on women to the same degree.
Same thing with prevention strategies.
So we're basically saying like, yeah, heart attacks are important but we only really care about when they happen in men.
And when they happen in women, well, you know, we'll just kind of...
..we'll extrapolate from the studies that we've done on men, or we'll extrapolate from what we know about how men present to the emergency room with a heart attack, and we'll just hope that that's good enough for women.
And it's not, it's definitely not.
It's actually quite frightening.
'Cause for men we know if you are experiencing a heart attack one of the symptoms is like the arm.
Mmhmm.
But for women it presents itself completely different.
Right, atypical, yeah, exactly.
It'll be a different sort of presentation, and then that makes it difficult from the perspective of, say, an emergency room doctor who's trained with a certain idea of what a heart attack is.
And then, if a woman comes in with a different set of symptoms then that just goes down...
..you kind of go down from a diagnostic perspective a different sort of pathway of what...
Okay, she doesn't have the sort of typical chest pain radiating down to the arm and into the jaw.
Might be more like nausea, or dizziness, or those types of symptoms.
And that's not on your radar as something that you think might be going on, then you're more likely to say, "Oh well, you know, "it's probably nothing, or maybe it's anxiety."
Which is a very common complaint that many women have, which is absolutely backed up by research, that coming into an emergency situation with different types of presentations or pain often gets kind of pushed off as anxiety, panic, you know, mood issues, whatever, kind of brushed off.
Not that those things are not important as well but, you know, if you miss a heart attack by just saying, "Well, you know, you need to maybe just take a pill and relax "or go see your doctor and talk about your mood," then you're going to end up with women dying who, if they presented in a different way or in a male body, might've been recognized and might have been treated more appropriately.
So this is like a big consequence when we miss these things, and when we just kind of brush things off because we're taught to think of typical chest pain and not atypical chest pain as a presentation for heart attack.
It wasn't until 1993 that the United States put into law that women and, I hate this word, 'minorities', so-called minorities be included in clinical trials.
What's been the effect of that decision more than 30 years on?
So there has be-- It's been slow progress basically, is the way to sum it up.
There has been more inclusion of women into clinical trials.
But women's health research is still majorly underfunded, under resourced, there's just not as much interest, there's not as much drive to study diseases that affect women.
And then, diseases that are studied tend to be, what we call, the bikini conditions.
So, reproductive organs and breast disease. You know?
You know?
We don't look into things like why do women have higher rates of autoimmune disorders?
We just don't know.
Which is not a really good way of looking into the problem, there's not, again, this comes back to the "you measure what you treasure". You know?
You know?
Do we care about why women have higher rates of auto-immune disorders from a societal perspective?
We don 't really because we're not looking into it at the same degree.
So there's definitely been progress in the last few decades but we're not where we need to be, not even close to where we need to be.
1993, more than 30 years, now women are included in clinical trials.
How has this policy changed, pushed forward our understanding of women's health?
It definitely helps.
But, again, it's just one small step. You know?
You know?
We're still... we need more interest in women's conditions, we need more funding.
Going back to, you know, in the last 30 years there's been more women moving into medicine and moving into medical science but we're still not seeing enough women in leadership.
And in leadership, in medical leadership, in research leadership, that's where those decisions get made about what studies get funded, what grants are given out, what the focus of a particular department is going to be if they're going to participate in clinical research.
So, you know--
How do we get more women into these positions?
How do we get more women in leadership in general, you know?
You know?
Like it's a lot of the same kind of glass ceiling sort of problems in medicine.
Um, it's that it becomes difficult for women to get into positions of leadership because it's often very demanding timewise, very demanding, there's the motherhood penalty.
You know, if you take some time away for maternal leave, parental leave, you know, that is seen as a strike against you.
There's also research showing that women who don't have kids are still subject to the motherhood penalty because there's an assumption that they have kids or that they will someday have kids.
So still kind of this negative association.
There's lots of evidence of gender bias when it comes to just deciding who, you know, with hiring committees, or promotional committees, deciding who's going to get a certain role.
So we see what's called the leaky pipeline.
You've got lots of women moving into medicine at the lowest level, like the medical school level.
Like we have much higher numbers of women matriculating into med school, that's been true over the last generation or so, a quarter century.
But then, at every stage of leadership we lose women.
So, you know, when it comes to head of a department you lose a certain number of women.
Or any kind of research leadership we lose a certain number of women.
And then, when you get to the top things like who are the deans of medical schools, there have only been a handful compared to the number of medical schools that we have.
Leadership in terms of medical associations, and likewise with research.
So there's just only a few that make it to the top, and a few are not enough.
We need a n-- We need better representation.
A plurality of women would be great.
Having actual equitable representation would be ideal, but we don't... we're pretty far off from that goal.
But even just having more women, uh, more women representing also underrepresented communities.
So, more Black and Indigenous women would be fantastic, that's a huge problem as well in medicine.
Those communities are very underrepresented.
And so, likewise, our research does not reflect the interests of the people who are in leadership.
Like the interests of people who are in leadership but not the people who need the research most.
And I guess, too, there's a case to be made for lived experience because if you are a woman and maybe have dealt with fibroids, endometriosis, have experienced menopause, then those are things that you are more...
..you feel those things, and you wonder, "Why hasn't this thing been studied?"
Um, you know, it feels as if there's so much change happening right now in the world.
What's happening in the US with President Trump's second stint as President, a lot's happening.
And, earlier in 2025, the United States came close to gutting the Women's Health Initiative, which is a long-term study which was started in 1991.
It focuses on preventing a variety of diseases and disorders for post-menopausal women.
The study has led to discoveries in women's health on everything from chronic illness, osteoporosis, cancer, and hormone therapy, and more.
Did that near-miss send a bit of a... a chill, like, throughout the scientific community of what was going--
..the repercussions?
Yeah, absolutely.
And we still-- They've backed away from their statement that they were going to cut a bunch of funding, but they haven't really made it very clear what's going to happen.
So it's in that sort of, you know, uncertain state that's true of a lot of the US Government right now.
There's sort of a lot of uncertainty about what's going to happen next.
And so, yeah, the Women's Health Initiative is kind of in that category of, you know, they said they were going to gut it, then they kind of backed away a little bit a few days later.
But it's still unclear what the status actually is.
So it's a bit of a TBD, we don't really know.
But it is pretty scary, um, similar to what's been going on just throughout the US in terms of medical research, there's been a lot of gutting, and cuts, and affecting medical research and public health.
So it's a scary environment right now anyway where we just don't really know what's happening.
But definitely for women's health watchers, um, people who work in women's health, the potential loss of the Women's Health Initiative is quite scary, too.
We're talking a lot about the United States in this episode.
How is Canada doing in this?
(Inhaling sharply) Um, you know, Canada is not a pioneer when it comes to women's health research.
You know, I'd say we're probably similar to a lot of other Western countries.
There was a recent study looking at how much women's health issues get funded in terms of medical research, and it's still like something like 6%.
Like it's in the single digits in terms of all research.
So we're in the single digits percentage wise when it comes to where our research funding gets allocated in terms of health issues.
And so, I would say we're not, you know, Canada is not particularly a champion of women's health research.
There's still a lot left to be desired.
When the new budget comes out that there are going to be cuts to women's programs.
Um, like income equity, gender-based violence, reproductive rights, and these have knock-on effects in terms of women's health as well.
So, I'm a little concerned that we might actually be going backwards when it comes to women's health in Canada.
I should mention that the NIH oversees the Women's Health Initiative.
Um, it's a little chilling to hear that because it feels as if this could be an opportunity for Canada to actually step up if we are indeed a feminist nation.
The Federal Government should at least be trying to fill in those gaps.
A lot of US doctors and scientists are looking to leave the United States.
Would them coming here help with the efforts to study women's health?
It would help if there's money, you know, if there's funding.
Like, research always comes down to funding and the finite amount that is available for research.
So, resources in terms of people power, that's fantastic, but then research grants is the other part of it.
So I think it's hopeful, I definitely would love a brain drain that works, you know, in our favour.
And absolutely this would be a great time for Canada to step up on the medical research stage, not just in women's health but just more broadly.
We'll see what happens, we'll see what happens.
What are your hopes going forward for clinical trials in women's health?
So, I would-- Well, first of all, I would hope that whatever Ottawa's deciding in terms of funding for women's programs that decision is reversed, and that we don't have massive cutbacks in terms of women's programming, like it seems we are going to.
And then, we need an influx of interest in terms of research grants and bodies, and people who are interested in women's health.
I think there is an interest because, again, we have more women moving into medicine, we have more women moving slowly into positions of authority, leadership, and research, and medicine.
So there is a drive there.
But we need the resources.
So, more funding, more resources, and just an expectation, I think.
We should have an expectation, as a society, that women's health is a priority, and that women's health research is not just sort of like an after thought after we deal with the important issues.
Um, you've been somebody in this space who's long advocated for the well-being of women.
And from the stories that I've been hearing from a lot of people, um, their pain is just normalized.
And it's... You have to figure out how to navigate a system where it's just tol-- You're being told on a consistent basis that it's not that bad, um, you have to wait, it's not what it is.
And it can end up being a very lonely experience.
So what do you say to women who are trying to navigate a system where historically we've done such a poor job?
And sometimes, like, your doctor might not be able to give you the information you need, and then you end up in the disinformation and misinformation rabbit hole of the internet.
Yeah, yeah.
So, yeah, trying to-- Like the online health discourse is full of just nonsense.
You know?
It's just like a firehose of good information and bad information, and it's really hard to figure out what's the right information.
So it's hard, especially if you are, as you say, isolated, maybe in a situation where you're disempowered, where you don't know what's going on with your body, where you're not getting good answers from the people around you or from the people you should trust to take care of you.
So, it's a very difficult situation to be in.
I would just hope that one of the good things about the internet has been to connect people who perhaps have, or are feeling isolated, or might have a more rare condition, or might be in a place where they're, you know, in a more remote location where it's harder to connect with other people who perhaps have the same condition, going through the same sort of thing.
So, to find groups online that can be like a patient advocacy resource is very helpful.
You know, again with the caveat that sometimes that leads to less helpful information.
Sometimes a bit of wellness disinformation or, you know, um, there are certainly a lot of health grifters that will seek out those spaces as well where people are vulnerable and opening themselves up, and talking about the experiences that they have.
So that's difficult.
Um, you know, to suggest what people do.
Like finding a resource that you can trust is the most important.
How to find someone that you can trust is difficult.
Definitely science-based information is going to be the most helpful.
So, finding something that is grounded in science rather than something that presents itself as contrarian sort of or heterodox, or, you know, the science--
Like the one weird trick of the internet. You know?
You know?
Your doctor doesn't want you to know this.
Or like, "Here's the secret that everyone's been hiding."
Like that kind of thing usually will lead you down a bad path.
Um, and finding supportive people who can just say, "You know, I experienced that too," or "Here's what helped me," or "Here's a science-based resource that I found helpful."
is going to be helpful.
Just finding that is what's difficult on the internet because it's just, again, this firehose of just nonsense.
And especially when you are sick and suffering, or maybe socially isolated, or dealing with whatever mental health issues can come out of having an untreated condition, that can be, you know, you're not necessarily in the best place to do research at that time.
So that's also quite difficult.
So, you know, it's a problem I think we need to solve from multiple different angles.
And it's really a societal problem.
And I hope people get an opportunity to check out your book when it comes.
Congratulations.
Thank you.
And thank you so much for making time for us, it's been a pleasure.
Yeah, my pleasure, too.
October 21st, 2025.
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This week's episode was produced by Matthew O'Mara and me, camera work by Max Stussi, production support from Jonathan Halliwell and TVO's Digital Media Services team.
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Thanks so much for listening.