I came here to make a similar comment to Grace. I will add that because of fertility women not only make ethically and chemically tricky test subjects, but also they make liability-fraught test subjects. The ethical problems can quickly slide into a legal problems. It is a tricky problem to solve because the researchers would need to disclose all of the potential foreseen risks and mention the unseen risks, which would likely repel most women who are pregnant or likely to get pregnant. And the researchers certainly wouldn't want subjects to get pregnant as the secondary liability for any harm to the child could be astronomical. (Think thalidomide, because that's what the researchers' lawyers will have in their heads as worst case scenarios.)
Researchers could pay upfront for the risk, but then the few women likely to consent to any sort of risk are those who are in extreme need of money. It becomes exploitive. (Think surrogacy markets.)
I have met people affected by the drug thaliomide, intended to prevent nausea in pregnant women, so I understand the concern about using pregnant women in drug trials. However, not using women at all or in limited numbers in trials is just as risky. It is the reason I participated in the Pfizer trial for COVID. Many of my friends thought I was crazy, but if no one participates then there is no vaccine. I hope that I represented post-menopausal women ( I am 57).
One thing that has plagued me is the way in which health problems that predominantly affect women are minimized, downplayed, or understood very poorly compared to men's health issues or issues that affect the sexes equally. I've encountered it before when I was trying to get to the bottom of recurring pelvic pain. I was never formally diagnosed but suspected endometriosis -- the only way to formally diagnose is to do surgery to look for it. There was no treatment available except "maybe try HBC?", which I opted not to because I felt that my personal psychological and blood-clotting risks outweighed the potential benefit, and because it doesn't actually FIX the problem it just pauses it.
Now I am experiencing it again as I have inexplicable post-viral symptoms (still not diagnosed) which overlap heavily with ME/CFS. There's no test for it. No treatment. There's not even agreement about the best management strategies, despite the fact that some formerly-favored management strategies may make matters worse. There's an assumption that because there's no measurable, obvious cause, and because it mostly affects women, that it must be 'all in our heads', that we must be lazy or weak or imagining things for attention.
I'm very pessimistic, so I don't know that we will (within my lifetime at least) get past the tendency to dismiss women's pain and suffering as imaginary or exaggerated in the absence of physical evidence. Instead, I have to hope that we will advance research ABOUT these conditions so we HAVE empirical, physical proof that something is Wrong.
I completely agree with you, Marie. I myself have a pelvic issue, symphysis pubis dysfunction (SPD), caused by childbirth, and there has been little to no research on it. One of the only research studies I have found on it was that of two male athletes who developed the condition as a sports injury, which is extremely rare. On the other hand, it’s estimated at least half of pregnant women experience SPD at some point during their pregnancy.
Re: pregnancy in particular, it’s important to remember that it’s remarkably difficult to get a statistically significant number of pregnant patients willing to participate in a clinical study (especially one having anything to do with vaccination!). Many women don’t want to partake in even nominally risky activities when their baby is involved.
I am a physician in a non-patient facing field (pathology). I don’t see the kind of soft sexism that’s referred to here often, but what I do see with increasing frequency is difficulty interpreting and reporting accurate test results because I may not even know the patient’s gender. A transgender woman who does not disclose their status as a person with XY chromosomes, or whose medical record is not set up to allow for this information to be easily accessed by other providers, can easily receive substandard or even dangerous care when reference ranges are wrong and test results misinterpreted. Our EMR thankfully has switched to a format that allows for easy access to this information, but many have not.
Two items that you hint at that I think are worth reiterating:
Including women and pregnant women in trials becomes a lot less risky and terrifying the more we *know* about women and pregnant women. The amount of disinformation and the general lack of knowledge about our bodies is directly related to the lack of women doctors and researchers and how (because, patriarchy) the study of our bodies has not been a priority.
I'd also say that we don't have a strong enough sense of the common good these days. Good points have been raised in the comments about how pregnant women, especially wealthier/more privileged pregnant women, are less likely to take the risk of being part of a trial. Which means that the potential risks are disproportionately born by the less privileged. The solution to that imo isn't to not do trials, but better messaging rebuilding our trust in medical institutions and creating that feeling of a social obligation to participate for the greater good. We need to get to a point of celebrating participation instead of chastising women for risking their future children.
Yes, I think if there was a stronger knowledge in general of how women's bodies work, especially in pregnancy, and greater willingness to fund and conduct animal studies, it'd be easier to do ethical phase 3 trials with pregnant and breastfeeding women. As it stands, it seems like a lot of information on drug risks during pregnancy is decades old.
Fair points, but I think it's more about a culture change in medicine than a gender change; the vast, vast majority of the OB/GYN population is actually female! But you can be sure that in female-headed OB/GYN offices as well as male-headed ones, birth control is still promoted as the gold standard for many "women's health" issues, rather than an effort to understand and get to the root cause of those issues.
I'm dealing with this on the patient side right now -- my psychiatrist says it's a personal choice whether the benefits of the medicine she prescribed are worth the risks to my nursing child. Okay, so what are the risks? Nobody knows! Good luck sweetie! I don't have any answers, just an overwhelming desire to scream.
There used to be a doctor from Lubbock, TX who did a lot of research on this issue, and many other doctors did not know about his work. I don't know if it's still available, but I relied on it a lot to make these kinds of decisions when I was breastfeeding.
I found it! I didn't think I could, so I didn't mention it before. Dr. Thomas Hale, and he runs the Infant Risk Center at Texas Tech! Years ago (my baby is 14) you could even email them questions when you couldn't find a particular med in their database.
This is such an important issue to talk about, Leah, thank you! The thing that always concerns me most about new drugs--not just vaccines--is specifically their effect on women and their fertility. As you've done an excellent job of pointing out, women of reproductive age are notoriously undersampled in clinical trials, precisely because our fertility and our cycles make us ethically and chemically tricky test subjects (in particular, our cycles and our immune systems are more intimately intertwined than most people realize, and it is borne out in things like a greater prevalence of autoimmune disorders in women). For this reason, women have historically not been studied en masse in clinical trials (unless, of course, it's a drug specifically intended for women)--and only *really* recently have things begun to change meaningfully in that regard (and I'm talking like only in the last ten years or so). I'm not sure what the population sample ultimately looked like for these vaccine trials, but a quick look at the inclusion/exclusion criteria for women of reproductive age for the Moderna trial indicates that they specifically wanted women who were on birth control (or abstinent), and who would remain on birth control for three months after the trials. This is most likely because they (understandably) wanted to prevent pregnancy in the test subjects, but in addition to giving us zero data on the vaccine in pregnant or breastfeeding women, it can also make it tricky to say how this vaccine will effect women who cycle naturally (as opposed to being on birth control), if the majority of their test subjects were in fact on hormonal BC (the synthetic hormones in BC change women's chemical makeup in more significant ways than we have been historically willing to admit). And because of the birth control requirement, we obviously also don't know how the vaccine will effect women (or their babies) who *do* become pregnant as a result of these criteria. So, just a few different factors that stand out to me as a woman of reproductive age, who cycles naturally--and specifically as one who knows that pharmaceutical companies don't always cross all their t's and dot their i's when it comes to women of reproductive age (for reasons both ethical and logistical). This is also just another glaring example of how birth control is used to make women more like society's normative body--which is to say, the male body. Once again, the unspoken message here is clear: bodies that do not have a monthly cycle and cannot become impregnated are easier for science to study, easier to rely upon in the workplace, etc., and so bodies that *do* cycle are simply left by the wayside.
I'm kind of familiar with this view of men as the standard, because one of the places it crops up has affected my life significantly. The first people to do medical studies of autism studied only boys and men, which left out of their research any evidence of how the same genetic difference (autism) might present itself --- similarly or differently --- in girls and women. This has led to people telling each other that "girls don't get autism", because girls don't line up toy trains (perhaps because many girls aren't given toy trains, which are seen as masculine?) or refuse to play along with social scripts (perhaps because the pressure on girls to be sweet and nice and polite is more intense --- if a boy doesn't make small chitchat who cares?). And so, when I was a small child who "threw fits" in Walmart and large social gatherings, and didn't talk to people outside my own family, and didn't like dressing up or dolls or tea parties or any of the things normal girls liked to do, and hated hated *hated* tags in clothes and stiff collars and scratchy shirts, nobody said "maybe she's autistic". They said "What is wrong with her?"
Two decades later, it's pretty easy to weed out the wrong kind of doctor --- all I have to do is start, "Do you believe women can be autistic?" and then we go on from there to do you believe autism is a curse that needs a cure or is it okay to be different from the arbitrary social norms, and other controversial things.
Yes, me too! I am autistic, and from toddlerhood to age 12 I was diagnosed as on the spectrum, or they used different terming (e.g., sensory integration). It definitely affected me, I think I'm still working through a lot of it 15 years post-diagnosis. Part of the reason my regular pediatrician did put me on the spectrum was so I could get more services, like an IEP, which I did not have at that point, because I did not display it as a more standard learning disability or like a boy. It still happens now — I am going through trying different anxiety meds, and need one that helps with my more "visceral" moods/anxiety. I know I need to eventually need to find a new neuro and psychiatrist who specializes more in Autistic adults (not pediatric, which is what they all seem to be), which is hard enough, plus someone who understands autism is just different in females, and not a bad illness.
Doesn't it get infuriating they way it seems all the resources out there are for children, or parents of autistic children? It's like people think it goes away when you turn eighteen, which is another problem.
And yes. People hardly ever understand that autism isn't an illness. That might be one reason they're reluctant to diagnose kids (or adults) with it, because they don't want to insult or burden them. Which goes back to inaccurate stereotypes being all we hear about.
Yes, for sure. And it's such a broad spectrum, too. No, it does not go away at age 18, and people on the spectrum's needs vary so greatly, and while we can never meet everyone's needs, there should be more resources for kids and adults on the spectrum to catch more of the needs, at the very least (various services like transportation, housing, mental health care, daily tasks, employment, etc., off the top of my head), which there is nothing for currently.
I wonder if it is the same for ADHD? Girls with ADHD (me, diagnosed in my early 40's) are considered to be the exception to the ADHD rules, and I am curious if that's due to sexism in a similar way.
Thanks for drawing attention to this, Leah! I agree with what others have said but want to add to Grace Emily Stark and Ariel's comments about there being both logistical and ETHICAL challenges to including pregnant women in research.
When a vaccine/treatment is first being tested, researchers understandably want to avoid exposing fetuses because they are a vulnerable population. Ideally after testing in a non-pregnant population reveals few serious side effects, pregnant women and fetuses could then be studied with a little less fear of causing serious harm to them. I think it's a reasonable ethical concern that especially vulnerable people not be first to receive an experimental treatment when the possible side effects are unknown. There's also the PR angle, that no drug company wants to be branded as the ones who caused even a small number of serious birth defects or miscarriages.
The obvious tradeoff in this approach is that it will take longer for these vaccines/treatments to be approved and available to benefit this vulnerable population. The same thing happens with pediatric research -- we always have to wait several years for medications that treat a condition in adults to be approved to treat the same condition in kids. It's a delicate balance to think about whether the possible harms of Covid to pregnant women justify foregoing a cautious approach of testing the vaccine in non-pregnant individuals first.
Lastly, we always consider distributive justice in research. Ideally, the population that shoulders the risk of being test subjects for a new treatment/vaccine should also proportionately benefit from the new treatment/vaccine. This has been a huge issue in the past where minority and poor populations often serve as guinea pigs for treatments that never become accessible to them once approved years later. Pregnant women are an interesting population because the women who have the option to volunteer as test subjects will not necessarily still be pregnant later on -- they may not necessarily see themselves as part of the population that will benefit from the research in the future. I wonder if this contributes to the logistical challenge of finding pregnant women who are willing to participate in vaccine or medication trials.
As others have stated, the ethical question of potentially harming two lives rather than just one is likely the biggest factor in excluding pregnant women from trials, especially given how litigious American society is. Med student friends have told me that even basic obstetrical residency is hemmed about on all sides with prohibitions about what student doctors can do and cannot do in the exam/delivery room, because their skills, like a new drug, are an unknown quantity for which no one wants to be liable.
I'm trying to get pregnant right now and hearing that there was zero data about the coronavirus vaccine and pregnancy was a real disappointment--despite the fact that prelim data does show an increased risk for severe outcomes for covid in pregnant women. I get that there are limitations and I am so grateful to the scientists who developed the vaccine, but I will probably abstain from getting it myself until after pregnancy (unless I want to wait two months after I get vaccinated to start trying again!? or something!? which is probably BS anyway!???).
This underscores why it is so important for healthy, low-risk individuals to get vaccinated. High risk individuals have to rely heavily on herd immunity for protection.
There is a resource which does collect outcome data the infant risk center at texas tech run by dr Hale. I called them and spoke to a nurse when I was pregnant and nursing to find out if my psych meds were safe when my MFM practitioners had little detailed info. More people should be aware of this vital resource
Fascinating thread here! I think it's also worth pointing out the irony that the one major pharmaceutical designed for, by, and (I assume) tested on women (HBC) also turned out to have serious long-term side effects that still aren't much discussed. How could this be? One might have expected that when a drug was targeted exclusively to women, it might have turned out to be better for them. Of course, I can imagine a number of significant factors (prior research on women's cycles being lacking, early enthusiasm for HBC, a certain kind of feminism relying on contraception etc. etc.). I can also see how the fact that the default mode for American women in 2020 is to be on HBC would diminish the pool of test subjects for cycling women who could conceivably consent to be test subjects for other medications...
I came here to make a similar comment to Grace. I will add that because of fertility women not only make ethically and chemically tricky test subjects, but also they make liability-fraught test subjects. The ethical problems can quickly slide into a legal problems. It is a tricky problem to solve because the researchers would need to disclose all of the potential foreseen risks and mention the unseen risks, which would likely repel most women who are pregnant or likely to get pregnant. And the researchers certainly wouldn't want subjects to get pregnant as the secondary liability for any harm to the child could be astronomical. (Think thalidomide, because that's what the researchers' lawyers will have in their heads as worst case scenarios.)
Researchers could pay upfront for the risk, but then the few women likely to consent to any sort of risk are those who are in extreme need of money. It becomes exploitive. (Think surrogacy markets.)
I have met people affected by the drug thaliomide, intended to prevent nausea in pregnant women, so I understand the concern about using pregnant women in drug trials. However, not using women at all or in limited numbers in trials is just as risky. It is the reason I participated in the Pfizer trial for COVID. Many of my friends thought I was crazy, but if no one participates then there is no vaccine. I hope that I represented post-menopausal women ( I am 57).
One thing that has plagued me is the way in which health problems that predominantly affect women are minimized, downplayed, or understood very poorly compared to men's health issues or issues that affect the sexes equally. I've encountered it before when I was trying to get to the bottom of recurring pelvic pain. I was never formally diagnosed but suspected endometriosis -- the only way to formally diagnose is to do surgery to look for it. There was no treatment available except "maybe try HBC?", which I opted not to because I felt that my personal psychological and blood-clotting risks outweighed the potential benefit, and because it doesn't actually FIX the problem it just pauses it.
Now I am experiencing it again as I have inexplicable post-viral symptoms (still not diagnosed) which overlap heavily with ME/CFS. There's no test for it. No treatment. There's not even agreement about the best management strategies, despite the fact that some formerly-favored management strategies may make matters worse. There's an assumption that because there's no measurable, obvious cause, and because it mostly affects women, that it must be 'all in our heads', that we must be lazy or weak or imagining things for attention.
I'm very pessimistic, so I don't know that we will (within my lifetime at least) get past the tendency to dismiss women's pain and suffering as imaginary or exaggerated in the absence of physical evidence. Instead, I have to hope that we will advance research ABOUT these conditions so we HAVE empirical, physical proof that something is Wrong.
Yes! I agree with Analisa, that phrasing is *gold*, Marie.
I completely agree with you, Marie. I myself have a pelvic issue, symphysis pubis dysfunction (SPD), caused by childbirth, and there has been little to no research on it. One of the only research studies I have found on it was that of two male athletes who developed the condition as a sports injury, which is extremely rare. On the other hand, it’s estimated at least half of pregnant women experience SPD at some point during their pregnancy.
Oy gevalt.
Oh, I love this. Pathologizing the normal and normalizing the pathological. Thank you.
Re: pregnancy in particular, it’s important to remember that it’s remarkably difficult to get a statistically significant number of pregnant patients willing to participate in a clinical study (especially one having anything to do with vaccination!). Many women don’t want to partake in even nominally risky activities when their baby is involved.
I am a physician in a non-patient facing field (pathology). I don’t see the kind of soft sexism that’s referred to here often, but what I do see with increasing frequency is difficulty interpreting and reporting accurate test results because I may not even know the patient’s gender. A transgender woman who does not disclose their status as a person with XY chromosomes, or whose medical record is not set up to allow for this information to be easily accessed by other providers, can easily receive substandard or even dangerous care when reference ranges are wrong and test results misinterpreted. Our EMR thankfully has switched to a format that allows for easy access to this information, but many have not.
I have noticed just in the last six months or so that new patient forms are asking for "sex assigned at birth." This seems wise.
I love this post and discussion!
Two items that you hint at that I think are worth reiterating:
Including women and pregnant women in trials becomes a lot less risky and terrifying the more we *know* about women and pregnant women. The amount of disinformation and the general lack of knowledge about our bodies is directly related to the lack of women doctors and researchers and how (because, patriarchy) the study of our bodies has not been a priority.
I'd also say that we don't have a strong enough sense of the common good these days. Good points have been raised in the comments about how pregnant women, especially wealthier/more privileged pregnant women, are less likely to take the risk of being part of a trial. Which means that the potential risks are disproportionately born by the less privileged. The solution to that imo isn't to not do trials, but better messaging rebuilding our trust in medical institutions and creating that feeling of a social obligation to participate for the greater good. We need to get to a point of celebrating participation instead of chastising women for risking their future children.
Yes, I think if there was a stronger knowledge in general of how women's bodies work, especially in pregnancy, and greater willingness to fund and conduct animal studies, it'd be easier to do ethical phase 3 trials with pregnant and breastfeeding women. As it stands, it seems like a lot of information on drug risks during pregnancy is decades old.
Fair points, but I think it's more about a culture change in medicine than a gender change; the vast, vast majority of the OB/GYN population is actually female! But you can be sure that in female-headed OB/GYN offices as well as male-headed ones, birth control is still promoted as the gold standard for many "women's health" issues, rather than an effort to understand and get to the root cause of those issues.
I'm dealing with this on the patient side right now -- my psychiatrist says it's a personal choice whether the benefits of the medicine she prescribed are worth the risks to my nursing child. Okay, so what are the risks? Nobody knows! Good luck sweetie! I don't have any answers, just an overwhelming desire to scream.
There used to be a doctor from Lubbock, TX who did a lot of research on this issue, and many other doctors did not know about his work. I don't know if it's still available, but I relied on it a lot to make these kinds of decisions when I was breastfeeding.
Do you remember his name?
I found it! I didn't think I could, so I didn't mention it before. Dr. Thomas Hale, and he runs the Infant Risk Center at Texas Tech! Years ago (my baby is 14) you could even email them questions when you couldn't find a particular med in their database.
So glad to see you posted this. They helped me too. You are also able to call and speak directly with a nurse
This is such an important issue to talk about, Leah, thank you! The thing that always concerns me most about new drugs--not just vaccines--is specifically their effect on women and their fertility. As you've done an excellent job of pointing out, women of reproductive age are notoriously undersampled in clinical trials, precisely because our fertility and our cycles make us ethically and chemically tricky test subjects (in particular, our cycles and our immune systems are more intimately intertwined than most people realize, and it is borne out in things like a greater prevalence of autoimmune disorders in women). For this reason, women have historically not been studied en masse in clinical trials (unless, of course, it's a drug specifically intended for women)--and only *really* recently have things begun to change meaningfully in that regard (and I'm talking like only in the last ten years or so). I'm not sure what the population sample ultimately looked like for these vaccine trials, but a quick look at the inclusion/exclusion criteria for women of reproductive age for the Moderna trial indicates that they specifically wanted women who were on birth control (or abstinent), and who would remain on birth control for three months after the trials. This is most likely because they (understandably) wanted to prevent pregnancy in the test subjects, but in addition to giving us zero data on the vaccine in pregnant or breastfeeding women, it can also make it tricky to say how this vaccine will effect women who cycle naturally (as opposed to being on birth control), if the majority of their test subjects were in fact on hormonal BC (the synthetic hormones in BC change women's chemical makeup in more significant ways than we have been historically willing to admit). And because of the birth control requirement, we obviously also don't know how the vaccine will effect women (or their babies) who *do* become pregnant as a result of these criteria. So, just a few different factors that stand out to me as a woman of reproductive age, who cycles naturally--and specifically as one who knows that pharmaceutical companies don't always cross all their t's and dot their i's when it comes to women of reproductive age (for reasons both ethical and logistical). This is also just another glaring example of how birth control is used to make women more like society's normative body--which is to say, the male body. Once again, the unspoken message here is clear: bodies that do not have a monthly cycle and cannot become impregnated are easier for science to study, easier to rely upon in the workplace, etc., and so bodies that *do* cycle are simply left by the wayside.
Such an important point, that even when women with "cycles" *are* studies, these cycles are BC "cycles", and not natural ones!
I'm kind of familiar with this view of men as the standard, because one of the places it crops up has affected my life significantly. The first people to do medical studies of autism studied only boys and men, which left out of their research any evidence of how the same genetic difference (autism) might present itself --- similarly or differently --- in girls and women. This has led to people telling each other that "girls don't get autism", because girls don't line up toy trains (perhaps because many girls aren't given toy trains, which are seen as masculine?) or refuse to play along with social scripts (perhaps because the pressure on girls to be sweet and nice and polite is more intense --- if a boy doesn't make small chitchat who cares?). And so, when I was a small child who "threw fits" in Walmart and large social gatherings, and didn't talk to people outside my own family, and didn't like dressing up or dolls or tea parties or any of the things normal girls liked to do, and hated hated *hated* tags in clothes and stiff collars and scratchy shirts, nobody said "maybe she's autistic". They said "What is wrong with her?"
Two decades later, it's pretty easy to weed out the wrong kind of doctor --- all I have to do is start, "Do you believe women can be autistic?" and then we go on from there to do you believe autism is a curse that needs a cure or is it okay to be different from the arbitrary social norms, and other controversial things.
Yes, me too! I am autistic, and from toddlerhood to age 12 I was diagnosed as on the spectrum, or they used different terming (e.g., sensory integration). It definitely affected me, I think I'm still working through a lot of it 15 years post-diagnosis. Part of the reason my regular pediatrician did put me on the spectrum was so I could get more services, like an IEP, which I did not have at that point, because I did not display it as a more standard learning disability or like a boy. It still happens now — I am going through trying different anxiety meds, and need one that helps with my more "visceral" moods/anxiety. I know I need to eventually need to find a new neuro and psychiatrist who specializes more in Autistic adults (not pediatric, which is what they all seem to be), which is hard enough, plus someone who understands autism is just different in females, and not a bad illness.
Doesn't it get infuriating they way it seems all the resources out there are for children, or parents of autistic children? It's like people think it goes away when you turn eighteen, which is another problem.
And yes. People hardly ever understand that autism isn't an illness. That might be one reason they're reluctant to diagnose kids (or adults) with it, because they don't want to insult or burden them. Which goes back to inaccurate stereotypes being all we hear about.
Yes, for sure. And it's such a broad spectrum, too. No, it does not go away at age 18, and people on the spectrum's needs vary so greatly, and while we can never meet everyone's needs, there should be more resources for kids and adults on the spectrum to catch more of the needs, at the very least (various services like transportation, housing, mental health care, daily tasks, employment, etc., off the top of my head), which there is nothing for currently.
I wonder if it is the same for ADHD? Girls with ADHD (me, diagnosed in my early 40's) are considered to be the exception to the ADHD rules, and I am curious if that's due to sexism in a similar way.
It's entirely possible! There's a lot of overlap between ADHD and autism themselves, as well as the stereotypes people have of them.
Thanks for drawing attention to this, Leah! I agree with what others have said but want to add to Grace Emily Stark and Ariel's comments about there being both logistical and ETHICAL challenges to including pregnant women in research.
When a vaccine/treatment is first being tested, researchers understandably want to avoid exposing fetuses because they are a vulnerable population. Ideally after testing in a non-pregnant population reveals few serious side effects, pregnant women and fetuses could then be studied with a little less fear of causing serious harm to them. I think it's a reasonable ethical concern that especially vulnerable people not be first to receive an experimental treatment when the possible side effects are unknown. There's also the PR angle, that no drug company wants to be branded as the ones who caused even a small number of serious birth defects or miscarriages.
The obvious tradeoff in this approach is that it will take longer for these vaccines/treatments to be approved and available to benefit this vulnerable population. The same thing happens with pediatric research -- we always have to wait several years for medications that treat a condition in adults to be approved to treat the same condition in kids. It's a delicate balance to think about whether the possible harms of Covid to pregnant women justify foregoing a cautious approach of testing the vaccine in non-pregnant individuals first.
Lastly, we always consider distributive justice in research. Ideally, the population that shoulders the risk of being test subjects for a new treatment/vaccine should also proportionately benefit from the new treatment/vaccine. This has been a huge issue in the past where minority and poor populations often serve as guinea pigs for treatments that never become accessible to them once approved years later. Pregnant women are an interesting population because the women who have the option to volunteer as test subjects will not necessarily still be pregnant later on -- they may not necessarily see themselves as part of the population that will benefit from the research in the future. I wonder if this contributes to the logistical challenge of finding pregnant women who are willing to participate in vaccine or medication trials.
As others have stated, the ethical question of potentially harming two lives rather than just one is likely the biggest factor in excluding pregnant women from trials, especially given how litigious American society is. Med student friends have told me that even basic obstetrical residency is hemmed about on all sides with prohibitions about what student doctors can do and cannot do in the exam/delivery room, because their skills, like a new drug, are an unknown quantity for which no one wants to be liable.
This just landed in my inbox. A little twist in the vaccine story: https://unherd.com/2020/12/the-vaccine-crank-who-saved-millions/?tl_inbound=1&tl_groups[0]=18743&tl_period_type=3
I note that the specter of death changes the risk calculation.
I'm trying to get pregnant right now and hearing that there was zero data about the coronavirus vaccine and pregnancy was a real disappointment--despite the fact that prelim data does show an increased risk for severe outcomes for covid in pregnant women. I get that there are limitations and I am so grateful to the scientists who developed the vaccine, but I will probably abstain from getting it myself until after pregnancy (unless I want to wait two months after I get vaccinated to start trying again!? or something!? which is probably BS anyway!???).
This underscores why it is so important for healthy, low-risk individuals to get vaccinated. High risk individuals have to rely heavily on herd immunity for protection.
There is a resource which does collect outcome data the infant risk center at texas tech run by dr Hale. I called them and spoke to a nurse when I was pregnant and nursing to find out if my psych meds were safe when my MFM practitioners had little detailed info. More people should be aware of this vital resource
Good news! https://www.startribune.com/healthpartners-studying-covid-19-vaccine-for-pregnant-women/600007722/
Fascinating thread here! I think it's also worth pointing out the irony that the one major pharmaceutical designed for, by, and (I assume) tested on women (HBC) also turned out to have serious long-term side effects that still aren't much discussed. How could this be? One might have expected that when a drug was targeted exclusively to women, it might have turned out to be better for them. Of course, I can imagine a number of significant factors (prior research on women's cycles being lacking, early enthusiasm for HBC, a certain kind of feminism relying on contraception etc. etc.). I can also see how the fact that the default mode for American women in 2020 is to be on HBC would diminish the pool of test subjects for cycling women who could conceivably consent to be test subjects for other medications...