Being stubbornly female
In which we discover it is actually possibly to include women in medical device trials
Hello, hello GFPs! Thought it might be just about time again for me to emerge from my book-writing hermitage and demonstrate some proof of life. I’m currently in the stage of stringing together all the draft sections I’ve written and turning them into a fully-formed narrative — or at least that’s what I thought I was doing. It is turning out to be more of a full-on re-write as so far each draft seems to have been me going down some esoteric rabbit hole that seemed really interesting and crucial to the book at the time but on re-reading mainly has present me asking past me what her problem is and why she has to make my life so difficult. Maybe if I ever write a fourth book I will finally figure out how to nail this writing a book thing in such a way that doesn’t involve months of unpicking and/or re-doing previous months of work 🤪
A solution other than telling women to shut up
IN BETTER NEWS! GFPs may remember that a few editions ago I was waxing lyrical about the introduction of at-home smear tests, which have been shown to increase the number of women actually getting a smear test — and in turn decrease the number of women dying from cervical cancer.
I was particularly heartened by this development because I recall being told off repeatedly for raising the issue of some women finding smears a lot more than “uncomfortable”; the fear was that by talking about the problem I was somehow creating the problem. Better to keep quiet and then women who find smears painful or traumatic will somehow not notice that they find them painful or traumatic and will keep attending every three years like good girls. OR, of course, you could listen to women and develop a solution that doesn’t involve telling us to shut up?
For those of us living in the UK at the time, the good news was purely theoretical, however, since at-home testing was still in its pilot phase — but no more! After a study found that offering at-home testing to women who were six months overdue on their smear significantly increased uptake, NHS England and Scotland have both announced that they will start offering at-home kits from January next year. This is excellent news. Cervical cancer is preventable if caught early — but last year only 66% of women took up their smear invitation. Researchers estimate that offering at-home kits could prevent 1,000 women a year from developing cervical cancer — which given around 3300 women in this country develop it every year, is huge.
Weird unharmonious bodies
GFPs, I have, if you can believe it, more good news! Yes, just consider this newsletter you semi-regular respite from…literally everything else. (My lawyer, Poppy*, informs me I should clarify that I am in no way promising that this newsletter will always be full of good news, since, being about women and written by me, it obviously will not; this is more of a FOR ONE WEEK ONLY affair).
Anyway, the good news is that someone finally figured out how to include women in heart device trials! As GFPs may remember from Invisible Women, female representation such trials is particularly poor, with the resulting outcomes for women being, unsurprisingly, also poor in comparison to men’s — and according to a study published last year, things have not improved. In fact, women are systematically underrepresented across all medical device trials, but the issue is particularly acute for cardiac devices (as indeed it is across cardiovascular research more generally — even though, as I believe will probably end up engraved on my tombstone given how often I have now said this: heart disease is the leading cause of death for women globally), where the average number of women included is 29%.
This study, however, which just published its one-year interim results, managed to include an absolutely unheard of FORTY EIGHT PER CENT of women in their trial. Interestingly, (for me, because I am a nerd), the study investigated CRT-Ds, an acronym GFPs may remember from Invisible Women: I wrote about a meta-analysis which found that women who would have benefited from CRD-Ts (basically a mini defibrillator) had been systematically denied this life-extending treatment. And the reason they had been denied it was because too few women had been included in CRT-D studies, which meant that no sex analysis could be done, the result being that no one realised that the threshold for implanting one needed to be lower for women than for men.
Anyway, because the researchers leading this ongoing study did recruit enough participants of both sexes, they have been able to sex analyse their results, and have uncovered a significant sex difference: while patients as a whole do well with these devices, female patients in fact had better results than male patients (which makes the historic denial of these devices to women even more unforgivable).
So, given medical device trials and heart device trials in particular have a terrible track record of recruiting female participants, how on earth did these researchers achieve the seemingly impossible? After all, I’d always thought the fault lay with us women for having these weird unharmonious bodies that mess up a trial by so much as glancing at it, not to mention our stubborn insistence on taking up all our free time with unpaid care work, leaving us simply unavailable for medical trials which cannot be expected to make themselves more accessible just to accommodate the ladies.
Except, turns out, they can! The two lead investigators for this trial (both women it’s worth noting) specifically set out to recruit more women to their study by doing completely unhinged things like *checks notes* organising “study visits to coincide with regular care appointments” and using “remote monitoring to reduce the study time demands.” They also “educated study teams about the importance of increasing female participation in clinical trials and provided practical guidance to help teams enroll more females” and they didn’t exclude participants based on age or comorbidities; these exclusions disproportionately exclude women, who tend to develop heart disease later than men (including such patients also of course has the added benefit of producing data that shows how the device works in, you know, an actual patient population rather than the patient population you wish you had).
The result of all this was that the researchers didn’t only streak past their original goal of recruiting a 40% female participant population, they also enrolled “greater proportions of several other groups that are typically underenrolled”, including patients from ethnic minorities.
It’s almost as if this stuff is entirely achievable if you actually care about, you know, actually doing it.
Holding Elon Musk to account
Just a quick little update from the world of using menstrual blood as a diagnostic tool / to secretly murder your husband…and for those of you who have no idea what I’m talking about, let me take you back to August 2021, when I wrote this newsletter in response to a tweet from a from a biomedical researcher called Federica Helena Marinaro.
Marinaro had just submitted a paper about the benefits of stem cell therapy using cells taken from menstrual blood, and she shared one of the peer review responses online. Unfortunately, the original tweet has been deleted, a loss to comedy for which I am holding Elon Musk personally responsible, but thankfully I have a record of what the response was because I read it out on a podcast episode I made the following year; you can of course listen (you should listen!) but because I’m extremely kind, I’ve screen grabbed the transcript of the relevant section for your reading delight:
Anyway, ladies I have good news and bad news to report. The bad news is, it still looks like you can’t murder your husband using your menstrual blood. Sry bbz.
The good news is, researchers have found an alternative use for menstrual blood and that is to diagnose endometriosis, an extremely painful disorder that can have serious ramifications for women’s fertility and their health more broadly. As GFPs will be aware from both my book and several newsletters on the topic, despite the fact that it is as common in women as diabetes, we remain terrible at diagnosing endometriosis, with women waiting up to a decade for any answers, let alone any treatment.
Existing diagnostic approaches involve intravenous blood tests and laboratory analyses coupled with imaging studies and extensive patient history collection for clinicians to make a definitive diagnosis. Such challenges contribute to delays in diagnosing endometriosis, with one study of 218 women revealing a delay of up to 12 years in the United States.
Enter: your period. Well, ok, your period has already entered the room, since this is of course not the first time we’ve spoken about using your period blood to diagnose a range of diseases, including endometriosis (IIRC we went into this in some detail in the podcast). What’s new here is the test that researchers have developed, which can detect endometriosis-linked proteins in your menstrual blood at much lower levels than in traditional tests, which could make early diagnosis much more feasible. Even better: since the test uses menstrual blood as opposed to intravenous blood, this is a test you could theoretically do at home on your own, rather like a pregnancy test — it could even be integrated into a menstrual pad, meaning you could be getting your endo diagnosis as you simply go about your day.
So far, this study just delivers proof of concept. Next up are clinical trials — and, (and this bit made me particularly excited) expanding the test “to detect additional disease biomarkers such as HPV and cervical cancer.” No more smears AND no more swabs? Please, you’re spoiling us! Future us, anyway. And specifically future us who haven’t yet reached menopause and still have periods. BUT STILL. This would be a major step forward for millions of women and overall, I am declaring it OFFICIALLY MORE GOOD NEWS.
* My lawyer Poppy
That’s it! Until next time, my dear GFPs….xoxoxo