The contraceptive headache

Caroline Criado Perez, narrating: It was a Friday afternoon in May 2020, and Chelsea Polis had just got a call from her concierge, John.

Chelsea: And he said somebody had something to deliver to me and he sounded very, very flustered and like there had been an argument, which was weird because John is unflappable, but it was the middle of lockdown and I think he was saying, “Why is this person in our building and what’s going on here?” So I was very confused. I had no idea what was going on.

Caroline, narrating: Eventually John asked the mystery visitor to leave the package in the lobby.

Chelsea: My husband went downstairs to get it, and that’s how I found that I was being served a million dollar lawsuit for defamation.

Caroline, narrating: I’m Caroline Criado Perez and this is Visible Women, my weekly podcast from Tortoise investigating how we finally fix a world designed for men. This week’s episode is all about good science, bad science and sex. Like many women, I’ve never got on that well with my contraception. The method I eventually landed on just felt like the best of a bad bunch. But why don’t we have more choices? Why don’t we have better choices? 60 years after the pill was first developed, where is all the groundbreaking research? I want to know, where can contraception go from here, and what or who is holding it back?

But first, let’s go back to Chelsea. 

Caroline: So Chelsea, please could you tell us what you do?

Chelsea: Sure. I’m a researcher in sexual and reproductive health. I did my PhD training in reproductive health and epidemiology and my undergraduate training in medical anthropology. And in particular, I’ve done a lot of work around how contraceptive effectiveness is calculated, including for fertility awareness based methods.

Caroline, narrating: Back in 2016, Chelsea was scrolling through social media when she came across a product called Daysy.

Chelsea: So Daysy is a device that collects basal body temperature and menstrual cycle start dates.

Caroline, narrating: You might have seen ads for similar gadgets. This is how it works. You take your temperature at the same time every morning as soon as you wake up. Then you input your reading into an app, which tells you if you can have unprotected sex without getting pregnant. The system is basically a flashy tech-assisted version of the handy old rhythm method. The idea is that since you can only get pregnant around ovulation and your body temperature changes around this time, taking your temperature every morning can work as a form of birth control.

Chelsea: I noticed some kind of strange social media post that they had made about a survey that they had claimed to do around how contraception impacts women’s lives, and I noted to them on Facebook that some aspects of how they were presenting the information from that survey was scientifically unsound. They had a very select sample of women that they had interviewed, all people who were using their devices or interested in using their devices, and they were making very broad statements about how women feel about contraception.

Caroline, narrating: But Chelsea’s Facebook comments were deleted pretty soon after she posted them.

Chelsea: They actually said, “We think your feedback is correct, but anything we post is to benefit the use and the eventual sales of our fertility monitors.” So that raised an early red flag for me.

Caroline: Over the following year, Chelsea kept an eye on Daysy’s posts, becoming increasingly concerned with how the company was marketing its product. By 2017, they were making claims about the effectiveness of their device as a contraceptive method.

Voice actor: Did you know the FDA blocks us from calling Daysy birth control or contraception? But she’s 99.3% effective. #TksBirthControl.

Caroline: Bear in mind, at this point, Daysy hadn’t even submitted their device for approval by the FDA – that’s the US Food and Drug Administration. In fact, the research required for submission hadn’t even been done. So it wasn’t really a question of the FDA blocking them as the ad claimed. They just hadn’t done the work. Oh, and that 99.3% statistic they were citing? That came from a 1998 study, a whole 16 years before Daysy was even introduced to the market. You don’t have to be a scientist to know that 16 year old studies that aren’t even on the device in question aren’t going to give you the most reliable figures. So Chelsea reported the company that developed Daysy, Valley Electronics, to the FDA. And the FDA made them take the ad down. But it wasn’t long before they were back with yet more claims, and this time they had their own study to flaunt.

Chelsea: So I thought, okay, great. They’ve done a study on this, thank goodness they’ve looked into this. Sadly, as I read the paper, I found that it was extremely flawed…

Caroline, narrating: Chelsea says that this paper, which was published in a journal called Reproductive Health, was really just a survey with a very low response rate of 13%. It wasn’t independent either, it was funded by Daysy and some of the co-authors were Valley Electronics employees. Most concerningly, it excluded a huge number of users.

Chelsea: Anybody who had fewer than 13 cycles of use. So basically anybody who had used it for a shorter period than 13 cycles were excluded.

Caroline, narrating: This means that if you were using the device for less than a year, perhaps because, you know, you got pregnant in that time, your data was excluded from the survey. So this study was meant to be investigating Daysy’s effectiveness as a contraceptive method, and they were basically factoring out anyone who might demonstrate that it was not effective.

Chelsea: And the impact would be to severely underestimate unintended pregnancy rates because you’re inappropriately excluding women who might be at the greatest risk of unintended pregnancy, including those who are least experienced with using the method because perhaps they stopped using it before they made it to a year without pregnancy. So it just made absolutely no sense.

Caroline, narrating: Although she already had a full-time job, Chelsea spent the next year of her life working to get this paper retracted. She had no skin in the game. In her words, she simply had a sense of duty as a public health professional. Meanwhile, Daysy’s device spread further and further on social media over the following year.

Chelsea: There were people making YouTube videos about the Daysy device and how effective it is and Instagram influencers saying things that I was really concerned could endanger public health.

Caroline, narrating: By May 2019, over a year after it was first published, the journal finally retracted the paper and published an editorial describing the methodology as fundamentally flawed. The retraction made the news, and Chelsea was interviewed by a few media outlets. This is what got her in trouble.

Chelsea: In some of those communications I referred to that retracted study as “junk science,” they claimed that that was defamatory. I don’t understand how something that’s been retracted for being unreliable can’t be described as junk science, but that they claim was defamatory. Again, this is a company that was marketing a $330 device as being a highly effective contraceptive method without having sufficient data to support that claim and also in violation of federal law in the Federal Food and Drug and Cosmetic Act, by not having the appropriate regulatory approval to sell it as a contraceptive method. When I referred to this company as unethical, they claimed that that was defamatory. So I just didn’t really understand language anymore.

Caroline, narrating: Chelsea’s story made me reflect on something I’d been noticing in my own social media for years. Whether it’s apps like Daysy that track your body temperature to tell you when you’re ovulating or astrological menstrual trackers that match the rhythm of your cycle to the waxing of the moon, new contraceptive advice and devices seem to be popping up everywhere, and they’re mostly being driven by tech companies. These apps represent themselves as the cutting edge of contraceptive innovation, but I feel like we’ve known for decades that the rhythm method is unpredictable at best, and that maybe we shouldn’t be relying on the moon for accurate information about our periods. How have we ended up here?

Donna Drucker: Humans have tried to either control their fertility, either encouraging it or discouraging it as long as we have human records.

Caroline, narrating: Dr. Donna Drucker is assistant director of scholarship and research development for the School of Nursing at Columbia University.

Donna: I’m the author of several books including Contraception: A Concise History. I am a historian by training and my main academic interests throughout my career have been the intersection of gender and sexuality with science and technology.

Caroline, narrating: Donna tells me that historically speaking, the most popular methods of contraception have been abstinence or withdrawal. They’re widely available and best of all, they’re free. But humans are nothing if not wonderfully creative animals, and so we’ve also dabbled in some more wacky methods.

Donna: In ancient Egypt, there’s evidence that people used crocodile dung mixed with honey as a barrier method. In Japan, women, you would use small oiled pieces of paper. The idea of animal skins or fishskins as condoms appears and reappears throughout the centuries. So a lot of methods were simply a matter of luck or guessing or just crossing your fingers.

Caroline, narrating: As well as these quite messy and presumably stinky barrier methods, people have also historically been partial to drinking their contraception.

Donna: Various kinds of herbs that you would drink in a tea. Please don’t do this, anyone who’s listening, please, please, please don’t do that. It could kill you. The ones that were most available in Western Europe would’ve been things like ergot, rue, tansy or pennyroyal, and these were all herbs that you would boil or heat up and drink them in a tea. How someone figured out that ergot, which is a fungus on the rye plant, served as contraceptive or abortifacient it’s really just lost, lost in time.

Caroline, narrating: Things got slightly better after rubber condoms were invented, but they weren’t the condoms we know and love today. These were reusable ones, which is obviously nice for the environment. They had to be washed after each use and if not taken good care of could develop cracks, which would make them less than effective. They were very thick and very stiff.

Donna: So it basically wouldn’t be very pleasant, but it would do the job as long as any kind of semen didn’t get through the cracks.

Caroline: I’m trying to imagine that… it sounds incredibly uncomfortable for the woman.

Donna: Yes, her pleasure was not really the main point of it if you were using these kinds of things.

Caroline: And when were these unpleasant rubber condoms being used?

Donna: I think there’s records back to the 18th century, like 1750s or so.

Caroline, narrating: Thankfully by around the mid 19th century, someone figured out how to vulcanise rubber, making condoms thinner and more pliable, which was I’m sure a relief to genitals everywhere. But for a long time, these less abrasive condoms were still not that readily available.

Donna: They would have to be hand rolled. There wasn’t like a machine that would make them. Later on you had the introduction of latex, which is much more flexible and could be much thinner and manufactured much more quickly.

Caroline, narrating: Two things dramatically changed the contraceptive landscape in the 1920s and ’30s. A new age of mass manufacturing made vulcanised condoms more readily available. And over in Japan, a fertility doctor called Kyusaku Ogino, finally figured out that ovulation tends to happen at around day 14 of a typical menstrual cycle. This changed everything. For a start, his discovery birthed the rhythm method.

Donna: A lot of Catholics in particular were looking for contraceptive methods. Ovulation timing gets pinned down in the scientific world, lots of Catholic writers in the US and in the Netherlands in particular think, Okay, hey, now we can tell people what to do and they don’t need to use condoms or anything else. So it really takes off in the mid 1930s.

Caroline, narrating: Science to the rescue of the Catholic church, what a turn up for the books. But Ogino’s discovery wasn’t just good for the Catholic church, it was also instrumental to the development of one of the most significant technologies of the 20th century, the contraceptive pill.

Donna: People started tinkering with hormones in the 1940s on animals, but testing of a hormonal method for human women doesn’t really get going until the 1950s. It gets approved by the US Food and Drug Administration in 1957 for regulating menstruation, then it is approved for birth control, particularly suppressing ovulation, in 1960.

Caroline, narrating: This hormonal tinkering caused serious consternation in the upper echelons of the Catholic church, who in 1968 felt compelled to issue an official announcement.

Donna: Which forbade the use of the pill by Catholic believers, which led to major divisions in the church and among people who had to make decisions about their faith versus their desire to control their families.

Caroline, narrating: There is no question that the pill had a huge impact on society and in particular on women. It liberated women sexually and socially, and it finally allowed them to control the timing of their own fertility. It was also the first time that women who suffered from a range of conditions from polycystic ovary syndrome to endometriosis had some form of relief for their symptoms. The pill had a huge economic impact too because women had more freedom to have careers and study. But while there is no doubting the importance of the pill to women’s lives, it has now been available for more than 60 years. And even though there have been a whole variety of formulations and different delivery mechanisms over that time, the fundamental technology we rely on to prevent pregnancy, as in, hormones, really hasn’t changed much at all. And it’s not perfect. You don’t have to look very far to find women complaining about the side effects.

Contributor: Splitting headaches every single month.

Contributor: I felt bloated. I gained weight.

Caroline, narrating: When we mentioned this episode on the Tortoise WhatsApp group, we were inundated with stories. For context, this group probably has around 40 women in it.

Contributor: Constant bleeding that didn’t let up for months.

Contributor: Just made my skin flare up like crazy.

Contributor: I just collapsed into a heap in hysterics. 

Contributor: My mood swings were quite extreme. It almost ended my relationship.

Contributor: Massively affected my self confidence.

Contributor: There’s lots of risks like blood clotting that keep me up at night.

Contributor: I was just a complete mess and I didn’t know myself or my own mind.

Contributor: It was just a general feeling of not feeling myself.

Contributor: There’s parts of my existence, that I don’t know if that’s me or if that’s the pill.

Caroline, narrating: And really if you want to understand exactly how imperfect our contemporary contraceptive choices are, you just have to look at the data.

Sarah Cairns-Smith: And if we just look at the US, about 65% of women age 15 to 49 are using contraceptives. And of those that are sexually active, almost 99% will use one method at some point.

Caroline, narrating: This is reproductive health expert Sarah Cairns-Smith.

Sarah: So this is showing overwhelming demand for the use of products and it all looks rosy. But the issue is when you look at outcomes; around 40% of all pregnancies globally are unintended. In the US the number is 46%, in Europe it’s 43%, and of those unintended pregnancies around a half are aborted globally. So I think this level of unintended pregnancy and abortion is eye popping and it suggests a real problem with our contraceptive options and their use.

Caroline, narrating: Since 1960, when the first contraceptive pill came on the market in the US, medical science has sequenced DNA, created test tube babies who now have their own babies and even cloned a sheep. So why has progress on contraception stalled? While I was researching this episode, I came across an article titled ‘Reboot contraceptive research, it has been stuck for decades,’ and Sarah was listed as a co-author. She’s a senior advisor at the Boston Consulting Group.

Sarah: I started life as a researcher. I worked with lots of companies in innovation and R&D, and I kept finding that women’s health was undervalued by most of my clients. And so I started feeling like there was a problem here. And then I started looking more closely at contraception and realised we’ve got a lot of very old options on the shelf. And it just drives me crazy that contraception, which is one of the most fundamental issues for virtually all of us, just gets so little attention from R&D and innovation.

Caroline: What do you mean by it being a limited set of options?

Sarah: So basically, if you arrayed all the options that are available in the developed markets on a supermarket shelf, what we would see is lots of different boxes with rings, patches, implants, pills. But if we picked them up and looked at the active ingredients, what we would find is that the vast majority have exactly the same set of hormonal contraceptive ingredients. And for some people they’re great, but if those active ingredients don’t work for you, you suddenly have very few choices, especially if you’re looking for a highly effective method. Basically, if you want a method that you can take right away I think the only thing we’ve really got is the condom, something that has a 12% failure rate with typical use. And if you’re a guy, I’m sorry, we only have the condom unless you want the permanent snip. So the options narrow really fast if the current methods don’t suit you.

Caroline, narrating: It’s really hard to measure if people are actually happy with their contraception because the only data point we have to indicate dissatisfaction is someone stopping using a contraceptive method. But faced with the choice between a method they’re not thrilled with and risking unintended pregnancy, most women are going to choose the former. It’s all they’ve got.

Sarah: There’s a lot of cycling. On average, people try three methods and about a fifth of people will try over five. So there’s clearly something going on that means people aren’t instantly finding what works for them. And for many people, it’s a lifelong struggle to find something that fits. But a concern about measuring this is that we think what may be happening is people are not stopping when they’re satisfied, they’re stopping when they realise there’s a limited set of options. And I think these top line numbers of unwanted pregnancy and abortion suggest people are not happy. But the dissatisfaction research has been really hard to get underneath of.

Caroline: And is there evidence of demand for better contraception and more options?

Sarah: Yes, the best evidence would be the launch Mirena in 2000, which is the hormonal IUD, which, rumour has it, was almost shelved as a product but has become a billion dollar product. So I think that’s pretty strong evidence that people want more and better contraceptives.

Caroline, narrating: But if the evidence is out there, why isn’t the market providing? After all, that’s how capitalism is supposed to work, right? Supply and demand. People want more products, better products, someone spots the gap and fills it. So why isn’t this happening with contraceptives? Sarah has a theory and it starts with women.

Sarah: Reproductive health has been seen as women’s health and it has a history of neglect. And few of the top decision makers are women. There are very few decision makers at all. Women’s issues have a lot of taboos. I could go on, but I suspect you get the point. The second thing I would point to is the really high hurdles in the developing and marketing of drugs. And it’s even higher when you are administrating to healthy individuals. So the efficacy and safety bar should be and is very high. Contraception is highly litigious, especially in the US, which is a site of a lot of the innovation. And this can scare off investors. I think the third thing is that we haven’t invested enough in the basic science. So in our article, we laid out some of the numbers. One of the most important funders in the world of basic science is the US National Institute of Health, and women’s health and STIs are only 1.1% of the NIH budget. And of that 1.1%, contraception/reproduction is only 21%. And that level of investment just won’t bring the types of advances we’re seeing in other fields. Pharmaceuticals companies typically spend about 20% of their sales revenue on R&D for new products, but with contraception, that figure is just 2%. And that really reflects the fact that pharmaceutical efforts have been focused on line extensions of existing products, which are actually much cheaper to produce than on fundamentally new mechanisms. My final one, and I have to admit this is my favourite, is that I think we have a perception of a lot of choice and a healthy existing market, but in fact, we have far fewer real choices and customers have to settle for what’s available. So our market signals are messed up. Taken together, all of these points mean that when a biotech or a pharma company is deciding which therapeutic area to work in, it’s easy to skip over contraception. There’s a lot of competition for investment dollars, and too often women’s health loses out.

Caroline, narrating: I talked about supply and demand, and of course it’s not strictly true that no one has spotted this gap in the market. I mean, look at Daysy, this device and others like it are clearly an attempt to fill that gap. And given what we’ve heard, is it any wonder women are turning to these tech-based methods when for so many of us, the current options available result in headaches, breakouts, anxiety, depression, weight gain, longer and more painful periods? We shouldn’t be surprised when women turn elsewhere for answers. Chelsea, who remember, was sued by one of these companies, thinks that the issue here is that unlike academia, big tech just doesn’t really have a culture of scrutiny.

Chelsea: Most other contraceptive methods have been developed by people who focus on contraceptive research and development, are well versed in many things about what that entails, including not only how to run appropriate clinical studies and how to get appropriate regulatory approvals and how to appropriately communicate with consumers about the risks and benefits of those options. And in this app and device space, we’re seeing developers who work on these methods who are not necessarily grounded in that kind of background. And I think it’s something that could be harnessed if there’s more collaboration between people in the tech space who might have fresh, new, bold ideas that the contraceptive field has not necessarily thought of before. But I don’t think ‘move fast and break things,’ which is sometimes a tech mentality, is always going to work when you’re talking about products that are intended to help prevent unintended pregnancy.

Caroline, narrating: Sarah also thinks we need more and better collaboration between researchers, tech companies and pharma. Our understanding of reproductive biology has come on quite a lot since the ’60s, but we don’t always make the most of scientific advances. If we did, we might discover new avenues for contraceptive research. But before any of that happens, what we really need is better data.

Sarah: I think we need to shine a light on the levels of dissatisfaction/satisfaction with existing products. It’s very important to demonstrate that there’s a vibrant potential market for new options. And I really want a better idea of the degree to which people are settling with existing products versus they’re completely happy.

Caroline, narrating: Sarah thinks that this data will help to encourage more investment into new and better birth control methods. And once these new and better methods are readily available, maybe women will be less likely to resort to the latest fad.

Now, I just want to address something I’m sure a few of you are wondering; why are we making this all about women? Why are we assuming that contraception is entirely a female responsibility? As my favourite online phrase goes, “What about the men?” Well, yes. What about them? Where is the pill for men? And if it existed, would it even work?

Caroline, speaking at a Tortoise ThinkIn: Do I think that if I were having a one night stand and a man told me, “By the way, I’m on the male pill,” that I’d be like, “Oh, great, brilliant. Let’s not use a condom?” No.

Caroline, narrating: This was recorded at a Tortoise live event I did a few months ago.

Caroline, speaking at a Tortoise ThinkIn: Actually, I’d be interested in a show of hands. Women, whether you are single or not, would you trust a man that you don’t really know? They’re all shaking their heads, because we don’t trust you.

Caroline, narrating: It turns out though that I might not have been entirely right on this one. I know, this is unprecedented.

Lisa Haddad: And it’s been believed that women wouldn’t trust men to use a contraceptive or that men really aren’t interested or don’t want to take anything that would have side effects. And what we’ve learned is that that is not true. That many men do want to share in the reproductive choice for their family.

Caroline, narrating: This is Dr. Lisa Haddad. Around the same time that Chelsea Polis was being served legal papers, and in the same city, Lisa was just starting a new job.

Lisa: I am medical director at the Centre for Biomedical Research at the Population Council. My role is to oversee clinical product development.

Caroline, narrating: The Population Council is a global non-profit that aims to improve access to safe reproductive health. Lisa’s research there shows that men are interested in the pill.

Lisa: Many men want to avoid pregnancy altogether and may not trust their partner to be using contraceptives. And so having more options for men is important, and having them have that opportunity to share, either to use a method alone in order to prevent pregnancy in their partner or to enhance the efficacy of the method that their partner is using. Because no contraceptive is perfect.

Caroline, narrating: So it’s not that men don’t want the pill, and contrary to what you might have heard on social media, it’s also not necessarily that they’re delicate flowers who just can’t handle the side effects. And when pharmaceutical companies are developing the pill for a woman, they’re comparing any adverse side effects to the risks of pregnancy. But this risk doesn’t exist for men. So when we’re developing male contraceptives, the regulatory burden is even higher. You might argue, I certainly do, that it doesn’t feel right for people to be denied the chance to make their own choices on this front. But this is the system as it stands. And until that changes, progress is always going to be tricky here.

It’s all so frustrating. There is such a clear need for better options, and yet all we’ve been able to find are excuses and obstacles. But then, Lisa tells me about something really exciting that she’s working on with the Population Council.

Lisa: So a vaginal ring is a user controlled contraceptive option. Obviously it’s round, it’s a ring. It’s pliable and easy to bend and place themselves inside the vagina. It usually stays there for a period of time, for one month, three months, or in the case of Annovera, they take it in and out over the course of 13 cycles. We have a ring that we’re developing. The ring that we are developing is a non-hormonal contraceptive that has added benefits.

Caroline, narrating: Vaginal rings do already exist. In the UK, you can get them on the NHS, but these rings use hormones. And what’s special about Lisa’s ring is that it is non-hormonal.

Lisa: The majority of contraceptive options that are out there are hormonal contraceptives. However, many individuals don’t tolerate hormonal contraceptives that well or are not interested in using hormonal contraceptives or have contraindications to hormonal contraceptives.

Caroline, narrating: As if that wasn’t exciting enough, this ring won’t just work as birth control, it will also protect against STIs.

Lisa: There is this overlapping burden of sexually transmitted infections and HIV that many women face. And so we’re trying to develop a product that has anti chlamydial, anti gonorrhoea, anti HIV, anti HSV, so anti herpes, and also have the potential benefit of improving vaginal health on top of it. So you’re building off the desire for people to prevent pregnancy, but also building off the desire for them to prevent themselves from getting these other STIs. And so that combined effect will hopefully enhance the adherence to a method and effective use of a method.

Caroline: I mean, it sounds amazing. I wish it had been around when I was in my twenties. And so this one that you’re talking about that you’re developing, does it have a name by the way?

Lisa: No.

Caroline: Not at the moment. Okay, so we’ll carry on calling it the ring, the new ring, maybe we’ll call it.

Lisa: I’m trying to think, but if you want to come up with a creative name, I would love that.

Caroline: Ill see what we can do.

Lisa:I feel like it’s the ‘does everything ring.’

Caroline:Yeah, the does everything ring. It does, it sounds magical. So what stage is the do everything ring at?

Lisa: So this one is, I would say is in early to middle preclinical. So I would say it will be several years until we actually advance it to the point where it will be in clinical trials.

Caroline, narrating: It could be over a decade until this magical ring or as I think it should be called one ring to rule them all, hits the market. And there are many hurdles to jump before we get there, but there are some other new products which are going to be available before that.

Lisa: The male hormonal contraceptive gel that I think will be advancing hopefully soon to a phase three trial, and our hope is that this will be the first approved male hormonal contraceptive that is available. I’m excited about a dual prevention pill that we’re developing, which is a combination of a oral contraceptive pill and HIV prevention, prep. We have a Dapivirine ring that we’re developing that is an HIV prevention product. And then we’re also developing a hormonal Dapivirine ring to offer that HIV and hormonal contraceptive prevention. Earlier in development, we have something called a fast dissolving insert. It looks like a pill that individuals will place prior to sex and it quickly dissolves, so it avoids some of the messiness of gels. And we have one that’s going to prevent from HIV, HSV, herpes, as well as HPV, and that is almost at the point where it’s in the clinic. And then we have another one that has the same properties but also has non-hormonal pregnancy prevention, which is exciting because that’ll also be an on-demand option for individuals who desire to just use a method when they want to have sex.

Caroline, narrating: It’s really exciting to hear Lisa talk about all these new and futuristic sounding products. And it’s particularly heartening to know this research is being done now because it could not be a more important time to be improving women’s contraceptive choices.

CBS News: Has ruled that states can decide whether abortion should be legal or illegal….

Lisa: What I see happening in the US, it is devastating, and unfortunately the laws here have become increasingly restrictive. And the impact is real. I see it in the choices that we have for caring for pregnant women who have desired pregnancies as well as those burdens that people have to go through now when they have an unplanned and undesired pregnancy. And there are also additional restrictions from people who don’t understand mechanisms of action for contraceptives. And so for example, certain states are trying to restrict access to emergency contraception or other forms of birth control. And so access is a problem already. We know that there are already burdens to access, whether it be cost, whether it’s restrictions in terms of facilities available to provide birth control. And we know that that’s only going to get harder. So I am nervous, I’m sad, and I’m hopeful that we can change policy before more people are hurt.

Caroline: Most of the people we spoke to for this episode also mentioned the impact of Roe v. Wade being overturned.

Chelsea: The issues around misinformation and disinformation when it comes to reproductive health have been perhaps a lot more in the spotlight quite recently due to Roe V. Wade falling in the United States. But it has been around, these issues have been around for quite some time, and we’ve always seen folks of a certain ideology using non-evidence based statements to push for ideological purposes and policies that are not always grounded in good data. That has frustrated me and motivated me.

Caroline, narrating: I asked Chelsea how it felt being served legal papers.

Chelsea: It was utterly surreal. I was not expecting to be sued for doing something that I considered and still consider a public good, something that took a lot of time and effort and expertise. I’d never heard of anything like this at that time happening to a scientist before. So I just had no context and no sense of where to turn. I didn’t have a lawyer. I’ve never needed a lawyer before, so it was scary.

Caroline, narrating: The thing that most confused Chelsea was not just that the lawsuit landed on her desk without any warning.

Chelsea: They never sent me a cease and desist letter or attempted to communicate with me in any other way.

Caroline, narrating: What baffled her was that Daysy had already had to retract their paper. And remember the journal itself called their methodology flawed. So Chelsea was right to have raised concerns.

Chelsea: I was eventually put in touch with a lawyer at a firm called Arnold & Porter and she and her team, very thankfully decided to take on my case pro bono, to take the case on for free because they are First Amendment lawyers who are interested in defending free speech and were very interested in the topic of the case, and I am incredibly fortunate that that’s what they decided to do.

Caroline: It just sounds really frightening. If you hadn’t had these lawyers agree to take your case on pro bono, what do you think you would’ve done?

Chelsea: That question haunts me. When I think about the potential for this to happen to other people who might not be as lucky as me, it compels me to fight and to be loud about the dangers of companies trying to suppress valid scientific or regulatory criticism in these ways. And I think that the public really needs to understand the chilling effect of meritless lawsuits that are intended to intimidate and to silence.

Caroline, narrating: It took almost two years of her life, but Chelsea was ultimately vindicated in court. The judge found that she was allowed to express her opinion.

Chelsea: I definitely remember how it felt, which was enormous relief.

Caroline, narrating: Valley Electronics appealed the decision, but they lost that too. Today, Chelsea is still pushing for more transparency and most importantly, good science from tech companies while continuing her own research in reproductive health.

Chelsea: I’ve done a lot of work looking at fertility awareness based methods because I think people are drawn to these methods if they prefer not to use hormones or devices. But the effectiveness estimates, it’s never going to be comparable to something like an IUD. Which for some people that’s okay, and for other people, they’re so intent on avoiding unintended pregnancy that that’s not going to be acceptable for them. So I think there’s interesting development in that space, but I think that needs to happen in conjunction with development of methods that do offer that very high efficacy regardless of how well a user uses the product.

Caroline: Chelsea’s story feels like a proper David versus Goliath moment. But we can’t rely on Chelsea for everything. What we really need is for funders, researchers, biotech and pharma companies to step up and fill in decades worth of innovation gaps. We’ve been stuck in the ’60s for too long, and as our reproductive rights are under threat, surely if there was ever a time to care, it’s now.

Chelsea: It probably all boils down to some combination of rage and love. I would say I have a lot of rage at how so many policies in the sexual and reproductive health space are all too often really disconnected from what scientific evidence tells us. And also a lot of rage at how sexual and reproductive health has become, at least in the country where I live and in many other places so politicised, and how some stakeholders really willfully use misinformation and disinformation to try to disempower people from controlling their bodies and their reproductive futures and their destinies. And so I’ve dedicated my career as a researcher to trying to ensure that people have clear, accurate, accessible information about sexual and reproductive health. And that’s the love part, right? That’s the respect for people who deserve and people who fight for and defend reproductive autonomy and dignity and justice. I think it’s just a core part of my worldview that everybody deserves to enjoy safe, consensual, pleasurable sex, including sex that’s not procreative.

Caroline, narrating: Thanks for listening to this episode of Visible Women from Tortoise. This episode is the last in season two. So if you haven’t already, go back and listen to season one and the other episodes in season two. We’ve investigated things like playgrounds, AI, car crashes, and even piano keyboards. Make sure to also have a listen to other Tortoise podcasts like The Slow Newscast, especially next week’s episode in which journalist Hattie Garlick does an even deeper dive into why we still don’t have a male contraceptive pill decades after we developed one for women. This episode was written and produced by me, Caroline Criado Perez, alongside Hannah Varrall and Patricia Clarke. The executive producer is Basia Cummings. It features original music by Tom Kinsella and sound design from Sam at String Cast Media.