7 Females being left out of medical research: another example of male bias?
While females being largely left out of sport science research may prevent them from optimising their performance, being left out of medical research can have serious health impacts. In Activity 6 Dr Alyson McGregor, an emergency medical doctor, looks at the outcomes when medical research is exclusively conducted on men and its results are then applied to women.
Activity 6 The male model as the framework for medical research
Timing: Allow about 15 minutes
Watch the TedTalk below by Dr Alyson McGregor as she explains the effects that medicines tested exclusively on males can have on female health. Watch from the start until 04:10 (‘… what else are we missing?’). Then answer the following questions:
- Why do you think medical research uses predominantly male subjects?
- What are the potential health impacts of this practice on women?
Download this video clip.Video player: boc_sfps_1_session1_activity6.mp4
Transcript
[MUSIC PLAYING]
[CLAPPING]
ALYSON MCGREGOR
We all go to doctors. And we do so with trust and blind faith that the tests they are ordering, and the medications they’re prescribing are based upon evidence. Evidence that’s designed to help us. However, the reality is that hasn’t always been the case for everyone. What if I told you that the medical science discovered over the past century, has been based on only half the population?
I’m an emergency medicine doctor, I was trained to be prepared in a medical emergency. It’s about saving lives, how cool is that? OK there’s a lot of runny noses and stubbed toes, but no matter who walks through the door to the ER, we order the same tests, we prescribe the same medication without ever thinking about the sex or gender of our patients. Why would we? We were never taught that there were any differences between men and women.
A recent Government Accountability study revealed that 80% of the drugs withdrawn from the market, are due to side effects on women. So let’s think about that for a minute. Why are we discovering side effects on women only after a drug has been released to the market? Do you know that it takes years for a drug to go from an idea, to being tested on cells in a laboratory, to animal studies, to then clinical trials on humans, finally to go through a regulatory approval process to be available for your doctor to prescribe to you?
Not to mention, the millions and billions of dollars of funding it takes to go through that process. So why are we discovering unacceptable side effects on half the population, after that has gone through? What’s happening? Well it turns out that those cells used in that laboratory, they’re male cells. And the animals used in the animal studies, were male animals. And the clinical trials have been performed almost exclusively on men.
How is it that the male model became our framework for medical research? Let’s look at an example that has been popularised in the media, and it has to do with the sleep aid Ambien. Ambien was released on the market over 20 years ago. And since then, hundreds of millions of prescriptions have been written primarily to women, because women suffer more sleep disorders than men. But just this past year, the Food and Drug Administration recommended cutting the dose in half for women only.
Because they just realised that women metabolise the drug at a slower rate than men, causing them to wake up in the morning with more of the active drug in their system. And then they’re drowsy, and they’re getting behind the wheel of the car, and they’re at risk for motor vehicle accidents. And I can’t help but think, as an emergency physician, how many of my patients that I’ve cared for over the years that were involved in a motor vehicle accident, possibly could have been prevented if this type of analysis was performed and acted upon 20 years ago when this drug was first released?
How many other things need to be analysed by gender? What else are we missing? World War II changed a lot of things. And one of them was this need to protect people from becoming victims of medical research without informed consent. So some much needed guidelines or rules were set into place. And part of that, was this desire to protect women of childbearing age from entering into any medical research studies. There was fear, what if something happened to the fetus during this study? Who would be responsible?
And so the scientists at this time, actually thought this was a blessing in disguise. Because let’s face it, men’s bodies are pretty homogeneous. They don’t have the constantly fluctuating levels of hormones that could disrupt clean data they could get if they had only men. It was easier, it was cheaper. Not to mention, at this time there was a general assumption that men and women were alike in every way, apart from their reproductive organs and sex hormones.
So it was decided, medical research was performed on men and the results were later applied to women. What did this do to the notion of women’s health? Women's health became synonymous with reproduction, breasts, ovaries, uterus, pregnancy. It’s this term we now refer to as bikini medicine. And this stayed this way until about the 1980s when this concept was challenged by the medical community and by the public health policy makers, when they realised that by excluding women from all medical research studies we actually did them a disservice.
And that apart from reproductive issues, virtually nothing was known about the unique needs of the female patient. Since that time, an overwhelming amount of evidence has come to light that shows us just how different men and women are in every way. We have this saying in medicine, children are not just little adults. And we say that to remind ourselves that children actually have a different physiology than normal adults.
And it’s because of this, that the medical specialty of Pediatrics came to light. And we now conduct research on children in order to improve their lives. And I know the same thing can be said about women. Women are not just men with boobs and tubes.
[LAUGHTER]
But that they have their own anatomy and physiology that deserves to be studied with the same intensity. Let’s take the cardiovascular system, for example. This area in medicine has done the most to try to figure out why it seems men and women have completely different heart attacks. Heart disease is the number one killer for both men and women, but more women die within the first year of having a heart attack than men.
Men will complain of crushing chest pain, an elephant is sitting on their chest, and we call this typical. Women have chest pain too, but more women than men will complain of just not feeling right, I can’t seem to get enough air in, just so tired lately. And for some reason, we call this atypical. Even though as I mentioned, women do make up half the population.
And so what are some of the evidence to help explain some of these differences? If we look at the anatomy, the blood vessels that surround the heart are smaller in women compared to men. And the way that those blood vessels develop disease is different in women compared to men. And the test that we use to determine if someone’s at risk for a heart attack? Well, they were initially designed, and tested, and perfected in men, and so aren’t as good at determining that in women.
And then if we think about the medications, common medications that we use, like aspirin. We give aspirin to healthy men to help prevent them from having a heart attack, but do you know that if you give aspirin to a healthy woman it’s actually harmful? What this is doing is merely telling us that we are scratching the surface. Emergency medicine is a fast paced business. How many life saving areas of medicine like cancer and stroke are there important differences between men and women that we could be utilising?
Or even, why is it that some people get those runny noses more than others? Or why the pain medication that we give to those stubbed toes work in some and not in others? The Institute of Medicine has said, every cell has a sex. What does this mean? Sex is DNA. Gender is how someone presents themselves in society. And these two may not always match up, as we can see with our trans-gendered population.
But it’s important to realise that from the moment of conception every cell in our bodies, skin, hair, heart and lungs contain our own unique DNA. And that DNA contains the chromosomes that determine whether we become male or female, man or woman. It used to be thought that those sex determining chromosomes pictured here, XY if you’re male, XX if you’re female, merely determined whether you would be born with ovaries or testes.
And it was the sex hormones that those organs produced, where what was responsible for the differences we see in the opposite sex. But we now know that theory was wrong, or it’s at least a little incomplete. And thankfully, scientists like Dr. Paige from the Whitehead Institute who works on the Y chromosome, and Dr. Yang from UCLA, they have found evidence that tells us that those sex determining chromosomes that are in every cell in our bodies continue to remain active for our entire lives.
And could be what’s responsible for the differences we see in the dosing of drugs, or why there are differences between men and women in the susceptibility and severity of diseases. This new knowledge is the game changer. And it’s up to those scientists to continue to find that evidence, but it’s up to the clinicians to start translating this data at the bedside today, right now.
And to help do this, I’m a co-founder of a national organisation called Sex and Gender Women’s Health Collaborative. And we collect all of this data so that it’s available for teaching, and for patient care. And we’re working to bring together the medical educators to the table. That’s a big job. It’s changing the way medical training has been done since its inception, but I believe in them.
I know they’re going to see the value of incorporating the gender lens into the current curriculum. It’s about training the future health care providers correctly. And regionally, I’m a co-creator of a division within the Department of Emergency Medicine here at Brown University, called Sex and Gender in Emergency Medicine. And we conduct the research to determine the differences between men and women in emergent conditions, like heart disease, and stroke, and sepsis, and substance abuse.
But we also believe that education is paramount. We’ve created a 360 degree model of education. We have programs for the doctors, for the nurses, for the students, and for the patients. Because this cannot just be left up to the health care leaders, we all have a role in making a difference. But I must warn you, this is not easy. In fact, it’s hard.
It’s essentially changing the way we think about medicine, and health, and research. It’s changing our relationship to the health care system. But there’s no going back, we now know just enough to know that we weren’t doing it right. Martin Luther King Jr. has said, Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And the first step towards change is awareness.
This is not just about improving medical care for women, this is about personalised, individualised health care for everyone. This awareness has the power to transform medical care for men and women. And from now on, I want you to ask your doctors whether the treatments you’re receiving are specific to your sex and gender. They may not know the answer yet, but the conversation has begun and together we can all learn. Remember, for me and my colleagues in this field, your sex and gender matter. Thank you.
[APPLAUSE]
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Discussion
It is quite shocking that most drugs that have been withdrawn are due to their side effects on women. This means women are essentially being used as test subjects in many cases.
- To ensure that research studies can be published the data needs to be reliable. Reliability means that if it you did the test on different days you would get the same results. This works when testing on men as they do not have the same degree of fluctuations in hormone levels that may skew any data. Thus, it becomes easier and cheaper to test men and then assume males and females are alike and will respond to drugs in the same way.
- This practice ignores that females may respond differently to the effect of drugs, such as in the example of Ambien where this sleep aid is metabolised more slowly by women meaning it may still be active when they are driving to work the next day. Although not mentioned in the video, you may be aware that Aspirin is another example of a drug that has different effects on males and females as it protects men against heart attacks but can be harmful to healthy women (McGregor, 2020).
It is not just women who have a cycle of hormones. Men have a daily cycle where levels of testosterone and cortisol change and this can impact on research findings.
A well-controlled research study would incorporate factors such as testing participants at the same time of day, controlling their exercise, food and drink intake prior to testing. However, for females the influence of the menstrual cycle has to be factored in. This means that testing of female participants would have to take place at the same time of their menstrual cycle (e.g. all participants were tested on day 5 of their menstrual cycle), and if repeated tests were done, they would need to be done at the same time of their cycle.