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Sensemaker Live: Egg freezing – what’s the deal with fertility preservation?

Why this story? Among those who work in contraception, it’s a well-worn joke: a male pill has been just five years away from hitting store shelves… for the last 40 years. But for a long time, male hormonal contraception has been a niche subject. Contraception, it’s generally accepted, is women’s work. In 1961 Enoch Powell, then Minister for Health, confirmed in the House of Commons that “birth control pills” could be prescribed on the NHS. Today, around 3.5 million women in Britain – and 100 million around the world – pop a pill every day. It has rocket-fuelled gender equality, spurred the feminist cause. But recently, another side to the contraceptive pill has emerged.  It started with women airing gripes about the pill, and experimenting with other birth control methods instead. Cycle-tracking apps, for instance. Then, last summer, when America’s constitutional right to abortion was revoked, that rumbling discontent became a roar. It takes two to make a baby, so why are women still overwhelmingly responsible for birth control – for the admin, side effects, stress and, when it goes wrong, the very grim consequences?   Suddenly, the old joke about waiting five years for 40 years wasn’t so funny. So we set out to solve the mystery of the missing male contraceptive pill. Hattie Garlick, reporter Transcript Hattie Garlick, narrating: At first, it was just a low murmur of discontent.  I wonder if you heard it, too? If you’re a woman, anywhere between, let’s say 15 and 50, I bet you did. Women were complaining about the contraceptive pill, side effects they’d put up with since puberty, and would likely deal with till menopause. Suddenly everyone was trying out a period tracking app. Ads for ‘natural’ contraceptive methods kept popping up on social media. Then, last summer, when news broke that the US Supreme Court had overturned Roe v Wade, ending the constitutional right to abortion, that murmur rose into a roar.  In the words of one viral tweet: “If a woman has sex with 100 random men in a year, she can still only produce one full-term pregnancy. If a guy has sex with 100 random women in a year, he can produce 100 full-term pregnancies. So why exactly are we only talking about regulating women?” It takes two to set the wheels in motion for a pregnancy and a birth. But all around the world, birth control remains overwhelmingly the burden and responsibility of women. Right now, there are 15 different methods of contraception available on the NHS. Just two of these are for men: condoms and vasectomies. And more and more women are now asking, ‘Why?’ How come, way over half a century after the contraceptive pill for women was launched, we still don’t have an equivalent for men? And then, one night a couple of months ago, I was sprawled on the sofa, watching the comedian Phil Wang on Netflix. And something made me sit up: Phil Wang: “I’m very grateful to all you ladies actually, for being on the old contraceptives. On behalf of the fellas, cheers. Appreciate it. It’s not fair they have to do most of it still. It’s not fair that you ladies have to do most of it still. It’s not like male equivalents haven’t been developed. They came up with a male pill just a couple years ago. They came up with a contraceptive pill for men, but the test subjects found that it actually sort of altered their body chemistry. Made them feel a bit sad. So, they all went: “hmmm… must not be ready yet. Women can keep using their pill, which we presume is perfect by now.” Hattie, narrating: Could that be right, I wondered? Was the science for a male contraceptive in place, just not men’s willingness to take it? So, I started digging.  And I found it. An international trial, sponsored by the World Health Organisation, that was cancelled suddenly in 2011 because of side effects experienced by the male participants.  But as I soon found out, that isn’t the full story.   I’m Hattie Garlick and on this week’s Slow Newscast from Tortoise, one of the biggest inequalities in global health: The Missing Male Pill.  Emily Glastonbury: So, the relationship I had with contraceptives was not great… Hattie, narrating: That’s Emily Glastonbury. She’s 32 and lives on a peaceful street in the Manchester suburbs, with her husband Dan and eight-month-old son, Jack.  And well, finding the right contraception has been a trial for her. First, she tried the pill… Emily: You go on it, as a girl, you go on it so young, before your body has stopped growing, before you get in tune with yourself because you’re so scared of getting pregnant when you’re young and it’s all very much encouraged by your doctors. It took a while for me to find one that didn’t sort of give me migraines or make me have horrific mood swings, it took a while to tailor that…  Hattie, narrating: So instead, she decided to try the contraceptive implant, a thin, bendy rod that’s placed under the skin of your upper arm and it slowly releases the hormone ‘progestogen’ into your bloodstream. Emily: I’d had the implant in my arm, and it hadn’t agreed with me, and I had to get it taken out and I’d bruised from here to here when I got it put in in the first place…  Hattie, narrating: She got terrible cramps and migraines. So, she switched to yet another contraceptive, an IUD, that’s a small T-shaped device, it’s put into your womb by a doctor or a nurse.   Emily: I heard somebody describe the pain of getting an IUD put in as ‘seeing colour’ and I think that is so apt. It was the moment it went in, I could have vomited, it was so painful. I remember her talking, the doctor talking to me afterwards, and I couldn’t even like hear her. I could barely like see her, because I was just in… I was just in so much pain. Hattie, narrating: But as Emily tells it, it’s not just a physical toll that contraceptives can take on you, it’s a mental load as well.  Emily: It is a heavy responsibility. It is like something that you have to constantly be thinking about like, have I taken the pill? How many have I got left? I was actually thinking the other day, I won’t ever get back those many, many hours I sat in walk-in clinics when I could have been… I could have been doing anything with those days. I could have been furthering my career, I could be playing a sport, I could be doing all of the things that men get to do on a day-to-day basis without even thinking about it.  Hattie, narrating: We’ll hear more from Emily and her husband Dan a bit later. But for now, she’s a sort of every woman. Because, sure, plenty of women love their contraceptives but Emily’s experience is far from rare. So, if there was a chance that there was another option out there, a way to share the burden with the men in our lives, I really wanted to find out why it wasn’t available yet. Richard Anderson: So, it’s always been a rather niche area, hasn’t it? But actually, it touches everybody, contraception, pretty much sooner or later. And so, it’s just got, you know, universal appeal. Hattie, narrating: That’s Professor Richard Anderson. He’s one of the world’s leading experts in male contraceptive research, he has been involved in a lot of ground-breaking trials over the past three decades. Including the trial I think Phil Wang was referring to: one that ran from 2008-2012, sponsored by the World Health Organization.  So, on a wet, moody morning, my producer Brenna and I caught an early flight to Edinburgh. Turns out, it was World Contraceptive Day and, that week, an anti-abortion group was holding protests outside of Edinburgh clinics that offer abortion services.  But at the Queen’s Medical Research Institute, where Richard is based, the calm was almost church-like. In his office, yellow files house decades of research. On the wall, beside a diagram of the male reproductive system was a child’s drawing of weather patterns— clouds, sunshine and lightning depicted in poster paint and glitter. The date on the picture said 2000, appropriate for a field that seems to have moved so slowly.  Richard: It hasn’t been fast, has it? You’re talking many decades since people first thought of this idea, and we still don’t have a product which is really pretty embarrassing isn’t it? Hattie, narrating: Richard has a slide dating back to the 1930s. It shows how when a man takes doses of testosterone, his sperm count drops, and then it bounces back again once he stops. But by the early 2000s, researchers were working with a different recipe for a male hormonal contraceptive.  Richard: A combination of two different drugs that were given as separate injections in that trial, but theoretically in a future product could be mixed together to be in a single product.  Hattie, narrating: The two drugs are testosterone and progestogen, which is widely used in female contraceptives. Both of these can slow down the release of the hormones that stimulate sperm production. And giving them together seemed to keep side effects in check. Eventually, researchers were ready to launch a Phase 2 trial. That’s a big deal. It was the first large-scale trial to test whether this combo would be safe and, crucially, whether it would prevent pregnancies.  Ten study centres were set up all around the world: Australia, India, Indonesia, Chile, the UK, Germany. The first volunteer was enrolled on September 4, 2008 and, from his test centre in the UK, Richard started watching the results come in. Richard: It all seemed to be going very well. There were no major side effects, I don’t think anyone in the trial locally left the trial because of side effects. But some people feel a bit different undoubtedly on this type of hormonal contraception. Sometimes they feel an increase in libido, sometimes they feel a decrease in libido, sometimes a bit moody. Hattie: And were there side effects that surprised or worried you, or ones you might have predicted? Richard: No, these are ones you get routinely in these trials. Hattie: And there were some mood-related, again I suppose. Did the severity or the scale of those trouble you? Richard: Not at all, no. As I say, we didn’t have anyone who left the trial locally because of them in that study. You know, it was all going straightforwardly.  Hattie, narrating: In fact, 99 percent of all the side effects reported were mild or moderate. One volunteer did die by suicide during the trial, but the tragedy was investigated and found totally unrelated to the study. Plus, the vast majority of mood disorders happened at just one study centre. And the results were exciting. Out of the 266 couples who participated, there were just 4 pregnancies, or 1.57 pregnancies for every 100 users. That’s a better rate than condoms, which average around 2 pregnancies for every 100 users. So, yeah. It was all going swimmingly. And then in March 2011, two and a half years after the trial started, that suddenly changed Richard: I think we all got, all the investigators got an email from the organisers. Hattie: Out of the blue? Richard: Yeah…  Hattie, narrating: The WHO had made a sudden decision to terminate the trial early. Volunteers were transitioned off the drug. Everything was wound up by May 2012.  But it wasn’t until a few years later in 2016 when the reasons for the cancellation were made public.  A study about the trial specified that it was down to, and I’m quoting here, “reports of mood changes, depression, pain at the injection site, and increased libido.”  The press jumped on the story. And women across the world were livid.  Michelle Wolf: “Aww poor men couldn’t complete the birth control study because it gave you pimples and made you moody. You guys call that side effects? I call that day four of a fairy-tale period. Men are such little b*****s. I mean one of the side effects is increased sex drive. You men always end up winning. The shot may as well be called ‘More sex, less babies.” Hattie, narrating: That’s comedian Michelle Wolf on the US Daily Show. It’s the narrative about the cancelled study that took hold, and the story that’s been told about male contraception ever since. Richard: And that’s why you’re still bringing it up and every journalist continues to bring it up ad nauseum. It’s really quite tedious to be talking about it fifteen years later. Hattie, narrating: I think you can hear the frustration in Richard’s voice here. And frankly, I feel bad for stoking it, because I can completely sympathise. Richard has been chipping away at the challenge of developing a male contraceptive for decades. He’s weathered plenty of ups and downs in the field.  Yet this cancelled trial is the one moment that’s raked up, again and again. And it’s a narrative that’s damaged progress. Richard: ​​I mean, there hasn’t really been significant activity within WHO in the field since. But I think it was a serious negativity for ongoing research within the WHO and Conrad, the co-sponsors with them. Hattie, narrating: But I do think that this trial is worth talking about. Just not for the reasons everyone has focused on. For a start, this whole idea that it was terminated because men in the trial couldn’t, or wouldn’t, shoulder the side effects that women have been quietly carrying for half a century… Richard: That’s just not the case. 70-80% of both sexes said that they wanted to continue. Hattie, narrating: Actually, it was a WHO oversight panel, a body called the Research Project Review Panel, that made the call to terminate, not the male volunteers.  I wanted to speak to some of these volunteers, to get their side of the story. I got some leads, but no dice.   And then, I found something else.  Nannette Cardon: I had been on the pill previously and had started noticing some of the side effects that do come when people in my age bracket, which is mid-thirties, take the pill– decreased circulation in your toes and fingers and the usual weight gain, and like that. Hattie, narrating: That’s a producer reading the words of a woman called Nanette Cardon. Way back in 1988, Nanette and her partner Gary Pascoe participated in an earlier trial of a male contraceptive. They were living outside of Seattle at the time and Gary and Nanette were interviewed about their participation for a story on PBS NewsHour. There wasn’t any video of that interview, but I found a transcript online and we’ve had producers step in to read the words of Gary, Nanette and the journalist.  Gary Pascoe: We had definite problems with existing birth control, which kind of led us to the program that I’m in now. Journalist: Gary and Nannette tried other birth control methods, but she was allergic to them. Thus, Gary volunteered to take part in the injection study, to see if the experimental shot might be an answer. That was in September. The sperm count has remained at zero since, and Nannette has not become pregnant. Nannette: After all these years of being the one to take the responsibility, it’s really neat getting a rest from that.  Hattie, narrating: The interview really struck me, for a few reasons. First: Gary’s no misogynist. Way back in the 80s, he was willing to share the burden with his partner, just like, when you look beyond the headlines, the volunteer participants in Richard’s later WHO trial appear to have been. Actually, a 2019 YouGov survey found that one third of sexually active men would consider taking a male version of the pill, exactly the same as the percentage of women who currently use hormonal contraception. Nanette is also keen to trust her partner with birth control, something else Richard’s research supports. Back in the late 90s, he surveyed ordinary women at family planning clinics in Scotland, China, and in South Africa. Only 2% of them said they wouldn’t trust their partner to use it.   But most of all, I’m touched by the familiarity of Nanette’s story. She’s expressing the same frustrations that Emily did at the start of this podcast. But she was talking 34 years ago. What happened when her trial ended? Did she have to go back on the pill? And if an alternative didn’t arrive in her fertile life, will it happen in mine? Hattie: So, I’m nearly 40, I guess if I’m….  Richard: I don’t think you’ll need to be relying on this, Hattie. I suspect this will be for your daughter, rather than yourself. Hattie: And do you think you will still be in this field of research? Richard: I will have retired, for sure personally. Hattie, narrating: I left Richard’s office with a burning question– if the science has been there for a while, and men’s wimpishness or unwillingness aren’t actually the villains here, then what the hell is holding male contraception back?  Hattie: Look, I know Richard said not to fixate on that cancelled trial, but something about it is still really needling me. Brenna Daldorph: What’s bugging you? Hattie: I think it’s those oversight panels. Hattie, narrating: That’s me having a chat with my producer, Brenna. And here’s what we were discussing. And bear with me because this gets a bit into the weeds.  So, there were two different oversight organizations keeping an eye on volunteer safety during the terminated trial. In January 2011, the first, the Data Safety and Monitoring Committee, examined the latest trial data and decided everything looked good.  But in March, just a few weeks later, the second one, the just-as-snappily named Research Project Review Panel, or RP2, took a very different view. It chose to terminate the trial.  Hattie: Ok, so have a look at this, I just got an email from someone who was involved in the trial. They don’t want to share their name, but they’re really not holding back… Brenna: Okay let me read this, ‘It was a stupid and unjustified decision made by people not experienced in male contraceptive research and panicked by a few cases of depression. Just plain dumb.’ Wow. Hattie: Right? But I guess the question is, do we buy that it was just incompetence? I mean, this is the WHO right, it’s not like we’re talking about some amateur science club. Hattie, narrating: I contacted the WHO, but they couldn’t put me in touch with anyone who had been on the committee back in 2011, and saying, and I quote here ‘the deliberations of committees of this kind are not public’. Eventually, I tracked a member down myself, but they were equally unforthcoming.  So, I emailed the WHO back to ask, how did these two panels come up with such different conclusions? Did they look at different data, perhaps? Or approach it with different concerns?  Hattie: Right okay, so, I’ve heard back.  Brenna: Okay, read it to me. Hattie: So, hold on a sec, they say ‘The DSMB and the RP2 looked at the same data and used the same metrics in assessing the adverse events. However, RP2 felt that because the study had already demonstrated the efficacy of the drug in reducing sperm counts there was no additional benefits in continuing.’ Huh. Brenna: I am, like, so confused right now. What does that even mean? Hattie, narrating: It’s not unusual for scientists to interpret data differently, but everyone I spoke to told me that it was highly unusual and controversial for a DSMC’s decision to be overruled like this. I didn’t feel any closer to understanding why these two expert panels, looking at the same data, for the same things, came to such completely different conclusions about the study’s safety.  And then I found this, on YouTube: John Amory: “I want to begin with a little bit of background that maybe some of you know. That was the premature stopping of the WHO’s study using testosterone and norethindrone because of side effects. It really led the whole field, I think, to stop for a moment and consider the issue of adverse effects, and also the ethics of continuing studies, or doing studies, for male contraception. I think this project is the first step into addressing the issues that were raised…” Hattie: Come and have a look at this, I think this might be a major clue. Brenna: What is it?  Hattie: So, it’s a panel debate, and it’s being hosted by a non-profit called the Male Contraceptive Initiative, in North Carolina. Should we try and get them on the phone? Brenna: Yeah, let’s do it. Logan Nichols: I’m Logan Nichols and I’m the Research Director at MCI. I certainly remember trying to learn more about the field and being introduced to that trial very quickly. I do remember seeing a lot of headlines when that paper was produced about men not being able to handle the side effects. They cancelled the trial because these guys are wimps and couldn’t deal with the acne or whatever. So, I think that it really is a black mark on the public perception of male contraceptives and of men who participate in these sorts of trials and I think that the framing is often lost. Hattie, narrating: And here it was. The piece that finally made sense of the puzzle for me. It wasn’t about the risk itself, but how that risk was framed. I know that sounds wonky but hear Logan out. During male contraceptive trials, you are giving healthy young men a drug.  Logan: So, one of the ethical considerations for contraception is, with female contraception, you’re mitigating the risk of pregnancy, which, you know, in of itself is a health risk. These young men are not getting pregnant and so, what are you mitigating? What health risk are you mitigating?  Any sort of health risk, technically, is too much if you’re not mitigating any health risk at the other end. Hattie, narrating: In other words: different standards are applied to the side effects experienced by men trialling contraceptives. But not because men are wimpy. Because pregnancy is a risky business for women. Men, though, don’t get pregnant. So, the risk/benefit balance to the user is different. Any side effects are set against the alternative of just life as an ordinary guy. And I get this. My second child was born by emergency C-Section. And while it was terrifying for my husband, too, the risks that he and I faced in that moment were really different.  But, in trials of male contraceptives, this adds up to what Logan’s panel called ‘a singular ethical situation’. His colleague Carmen Abbey put it well during their discussion.  Carmen Abbey: “In clinical trials, when we’re looking at adverse events and potential side effects, there’s not really an outline for how to interpret how much risk is too much risk.” Hattie, narrating: This foggy risk landscape also makes it hard for pharmaceutical companies to justify wading in. Logan: I’d say it’s risk, overall. We’re giving a drug to young healthy people for a very long time. And I think that they consider that a risky proposition that means it has to be incredibly safe. The efficacy barriers are also really high. This is contraception, 80% success is unacceptable. They don’t want to put in the R&D money that’s required at the beginning to create a product that actually meets those bars. And, furthermore, they think about litigation. Hattie, narrating: And without pharma’s backing, it’s hard to imagine funding the Phase 3 trials that are needed way before a product can sit on the pharmacist’s shelf in Boots. Add in other factors— today’s regulatory environment, which is far more rigorous than it was back when the first female pill was in development— and, suddenly, I could see why it’s taken so long.  But I was also worried. Is that it, then? No hope? The end of the road?  Well, not exactly. Logan: That’s one of the reasons we pitched this idea called shared risk, we’ve written a paper about it. I think it’s a really cool way we can frame things for regulatory agencies, for developers, to try and just reframe that risk such that if you administer a contraceptive to a male partner, you’re mitigating pregnancy risk in the female partner and thus the sum total of the risk for the partners is less than it would be if a pregnancy were to occur. Hattie, narrating: Logan’s paper, penned with colleagues, is called ‘‘Shared Risk: Reframing risk analysis in the ethics of novel male contraceptives”.  And here’s what it proposes: the risks associated with pregnancy could be considered applicable to both partners in a couple— after all, it takes two. Suddenly, if you’re developing, or approving, a male contraceptive, your risk thresholds are much clearer. You don’t want the risk to be higher than those female contraceptives carry. But if your drug carries a risk that’s the same, or better, lower, than those attached to current ones, it would be justifiable, ethically, to give it to man because it protects the couple, jointly, from the higher risks of unplanned pregnancy.  And if all sounds fanciful, well, consider organ donation. We already let donors undertake the risk of surgery, to benefit someone else. But organ donation is altruistic. Male contraception, less so. Because, of course, men do have a personal stake in preventing pregnancies, just not in ways that clinical trials commonly measure.  Logan: Men benefit from contraception, let’s be very clear about that. I think that we need to do more studies on how men benefit from contraception, what their educational, economic outcomes are whenever they experience an unintended pregnancy. All of these are understudied, which I think, by really understanding that data, we’ll be able to, again approach contraception as a couple’s issue instead of an individual piece, in the appropriate cases. Hattie, narrating: In some ways, it’s a little closer to the reasons loads of parents gave for vaccinating their healthy children during the pandemic. The kids benefited personally from Covid protection, but the positives of herd immunity were also a big motivating factor. And actually, Logan suggests that there would be benefits for the ‘herd’ in male contraception too.  Logan: I don’t say this a lot, but in terms of what male contraception can do for gender equality, I think it could make better dudes in general.  I think that men can acknowledge their contribution in reproduction, their responsibility in family planning, and because of that, we end up with relationships that are more empathetic, equitable, more communication, trust, more understanding about the burdens we all face in determining our reproductive future. That’s step 30, and we’re on step 2 in terms of getting men and women in a partnership to be more on an equal footing. Hattie, narrating: The gender pay gap, the domestic load… I was starting to get excited about the subtle inequalities that might be rebalanced if this first step, family planning and birth control, was more shared more equitably too. If the other 50% of the population knew the horror of forgetting to take a pill just once, could it tip the balance of sympathy towards women who get pregnant by accident? And Logan gives me some hope. Because even if the medical research world isn’t ready to calculate risk in this shared way yet, there are signs that the rest of the world may be. Logan: I think the time is right just in terms of a social moment. We’re in a post #MeToo era, we have men who are questioning their own role in reproduction, men who are wanting to take a more committed role with their partners. This kind of societal shift in which men are seeing themselves as reproductive beings for the first time and I think that makes this really an opportune moment. Hattie, narrating: In a 2019 YouGov poll, eight in ten Brits said men and women should take equal responsibility for birth control. But what’s more interesting is that men and women were almost equally likely to take that view. And in the States, in the wake of the reversal of Roe v Wade, there are signs of new eagerness from men. Searches for and enquiries about vasectomies are up. Hits to the MCI website, too And if the market starts clamouring for male products, it could change the risk calculations for pharmaceutical companies, encouraging them to reinvest in trials.  So, are we at the tipping point? Is now the moment we finally get male contraception? Dan: We met in 2014, at Glastonbury festival. I saw her and the birds sang and the butterflies flapped and I saw her pretty red hair. Hattie, narrating: That’s Dan Glastonbury and the red-haired muse he is describing is his wife, Emily, who we met at the start, the one who described her terrible experiences with birth control.  Dan: I badly flirted by telling her how good her handwriting was.   Hattie: That’s a novel line!  Emily: It is a novel line, and he wondered why I didn’t pick up on anything for a while. Hattie, narrating: My producer Brenna and I are perched on a sofa in their small, light-filled sitting room, equally transfixed by their baby Jack, who’s sitting on the floor, playing with a basket of rattly toys and by their story. Because like so many women, Emily has had a difficult relationship with contraception. But unlike most couples, the Glastonbury’s decided to do something about it.  Just before the pandemic, Emily was online when she saw an ad. Couples in long-term, monogamous relationships were wanted, for a clinical trial, testing a male contraceptive. Emily: It was advertised on Facebook, I guess I was just like the target audience for that. And I looked into it, and I thought this looks interesting, and, you know, something that I always thought was missing from our lives was a male contraceptive. So I sort of put it to Dan, and you were quite keen, weren’t you? Hattie, narrating: The trial Emily stumbled across is a global one. It’s being run right now, by the Population Council and the National Institute of Child Health and Human Development in the States. And some aspects of it are going to sound familiar because the lead investigator here in the UK is Richard Anderson. And though the drug they’re trialling is a gel, not jabs, it’s made of testosterone and progestogen, the same two active ingredients that were in our council trial. It’s also the first male contraceptive to make it to a phase 2 trial since that one. But, back to Dan and Emily.  Emily: Yeah, I think I had to have a couple glasses of wine. Dan: She got drunk, signed me up on Facebook and then said: we don’t have to do it, but, I want us to do a medical trial where you take a drug that will reduce your sperm count. And I was like, alright, this a lot! Hattie, narrating: Totally understandably, Dan had a few reservations. Dan: There’s a fear of signing up to a medical trial, and I also think so much of the gender roles that are taught to you as a male are like your fertility is your manliness. So, the idea of science messing with your ability to reproduce, somewhere in the back of your brain you’re thinking it’s taking away what makes me a man. There was a bit of fear around that in the back of my head. Hattie, narrating: In the end, though, they decided to go for it. Dan had actually always wanted to participate in a medical trial, more on that in a moment. Oh and also, Dan: It turned out the hospital’s right nextdoor to my favourite donut place. Hattie: Deal done! Dan: Yeah, that really helped things. Hattie, narrating: They applied and then they went through interviews and medical examinations. Dan: We started in April didn’t we, the whole chit chat process, and it wasn’t till we went to Glastonbury in June that I was actually on the gel. Emily: And then I had to continue to be on contraceptive until, it was the September of that year, I think. Dan: My sperm count was 42 million, and to get someone pregnant, you need at least 5 million, so they wanted me to be less than a million. I had to drop from 42 down to less than 1, and once it stayed at less than a million, I think for two months, not months, two check check-ups, which is like every 3 weeks, they were like: alright, here we go! You’re going to go off your contraception, I’m going to stay on the gel and we’re not going to have a baby. That was the plan. Hattie: How did your day change when you were on the trial? Dan: Nothing, like any other person I have to get up for work, shower and brush my teeth, so all that happened was that in the middle, I whack some gel on my shoulders and in 30 seconds, it was dry. That’s it. That’s as difficult as it gets. Hattie, narrating: And for Emily, the benefits were unexpected… Emily: I just became really in tune with like how my body goes each month. There were goods and bads of coming off of it for me. I started getting bad PMS again, and that’s something that I didn’t realise was a part of me, because I’d been taking hormonal contraceptives for so long. It was crazy to be like, oh, okay that’s what my body does every month and I’ve just been suppressing it. Hattie, narrating: And then, after a year of using the gel, the trial ended for them. How did it feel? Emily: It’s an indefinite end, isn’t it? The responsibility is handed back over, indefinitely. Because we have no idea where this is going to go. It’s been nearly four years since we signed up initially. Dan: It’s a bit like the end of the film The Graduate, where they get on the bus and they’re like: it’s the end, what happens next? Oh god, I don’t know what to do now. You’re gonna feel like you’re thrown out into the wilderness. Give us back the gel! Fend for yourselves! You had a taste of freedom, smell you later… Hattie, narrating: But Dan and Emily had decided to try immediately for a baby, so they were excited. Dan’s sperm count rose quickly, and eight months ago, Jack was born. And Dan says that participating in the trial has actually had an impact on the way they parent together.  Dan: I feel like going through the sharing of the contraception definitely made me, I think it made me much more aware of how much Emily does and I take for granted. And maybe how much women do, that I took for granted. It’s very easy to be an ally as a male, but that doesn’t mean you’re still actually hauling 50% of the weight.  Hattie, narrating: Actually, for Dan, there was something else significant about taking part in this trial.  Dan: I’ve got a book of 101 things to do before you die, and one of those things is take part in a medical trial. I had cancer when I was 19, which is the reason why I now have the book. Cuz when I got the all clear, after a year of chemo and radiation therapy, my mom bought me the book as, like, you’ve got your whole life ahead of you. Do all the things you can. When I wanted to do a medical trial, I just wanted to tick something off a book and I tried signing up to all sorts of medical trials— I literally had no idea what they did— that in no way would have affected me positively. But this medical trial was the medical trial for me. Because it has helped me develop as a man, as a human being, as a partner, as a husband, as a father. I didn’t expect any of that. I just wanted to tick something off a book and make some money. And in the end, I’m a better person for doing it. And I feel like I’ve contributed to science and the wellbeing of other human beings. So, thank you NEST study. Did not expect to say that, I’ve never really considered it before but, yeah, it’s improved so many things in my life. Hattie, narrating: I wanted to know if Dan was a happy anomaly. How positive were the other trial volunteers about their experiences? So, I asked Richard Anderson about volunteer recruitment. And for someone who appears to guard his professional expectations carefully, you can hear the edge of excitement in his voice.  Richard: So, when we started it was extraordinarily positive. We got masses and masses of phone calls, lots of couples came forward. It was going very very well, and, again, a lot of interest actually. It’s been really not difficult to find couples to do this.  Hattie: Do they share their motivations with you? Richard: Yeah, because we always ask why, and their main motivation is being fed up with there only being female methods around basically. Hattie: And the data that’s coming out of the trial, what’s that telling you about the efficacy of this method? Richard: Well, we don’t have final data obviously as yet, but it’s been amazingly successful. Hattie: I get the sense that you’re trying to kind of stay level-headed and not get too excited. Richard: Yeah, there’s a lot still to come. But I am amazed. I thought we’d get lots of pregnancies in this trial to be honest. Because, as you say, it’s very easy to forget to put the gel on and you know there was a worry that if you did, your sperm count would be bouncing back straight away, but that absolutely has not happened. Hattie, narrating: Efficacy rates appear to be better, even than for the pill. Exit interviews show that some women don’t want to return to female contraceptive methods and loads of couples have asked if they can re-enrol, just to continue taking it.  Actually, the results are so good that the study sponsors are already writing a protocol for the next step, a Phase 3 trial. That would be the furthest a hormonal male contraceptive has ever gone in trial. Uncharted territory. And so… this is the bit I don’t want to say. I’m loath to disappoint— or maybe you’ll breathe a secret sigh of relief, who knows. But that Phase 3 trial will likely need funding from a pharmaceutical company. And though there is hope of reawakening interest, for the time being, they still aren’t dishing out the dollars. The Male Contraception Initiative, where Logan works, told me that, in the last decade we’ve got data for, pharma’s total investment in male contraception was equivalent to just one third of a top paid pharma CEO’s annual salary. Even with funding, a phase 3 trial could take up to five years to complete and then come regulatory hurdles. The sponsors of the gel trial are hoping to meet with US regulators before this year is out and get some answers. But for the moment, no one knows quite how the FDA and other regulators are going to measure the risk/benefit ratio in a male contraceptive. So where does that leave us? The appetite is there, from men and their long-term partners, the science seems ready, the political environment primed. But the product? It’s still a long way off.  And for that reason, everyone I’ve spoken to for this story, while raving about its potential to change the world, they’ve discussed those benefits in terms of their children.  Dan hopes Jack will one day have the option of taking it, he’ll encourage him to, he says. And when I speak to Logan one last time, it turns out that his wife is about to be induced, the very next day, with their second child. He already has a son: Logan: He’s 4 years old, and so chances are—let’s just hand wave and say we’re 10 years away from the male contraception actually hitting the market— he will be among the first generation of users who have an option, or even more than one option, available to them as he becomes reproductively active. That’s something I think about a lot in terms of my kid and now my kids, and how we can create this equitable reproductive world that helps them. Hattie, narrating: In the current environment, with reproductive rights eroding and expectations for more gender parity rising, the knowledge that a male contraceptive won’t happen soon is a hard pill for many women, and some men to swallow.   But I started this story imagining that it might be about misogyny. In the end, it’s about risk. It’s about the risks that women have taken on for half a century. About the risks men are prepared to take to share that burden, but even more so, how the industry looks at risk. But it’s also about the risks we face if we don’t take those leaps. The risks of strangling reproductive rights. The risk of widening those inequalities of opportunity that stretch far beyond the moment a pill is popped or a gel is applied, into the future of our families, our workplaces and societies. Actually, we may not have true gender parity till one day, you walk into the family planning clinic and half the people sitting in those rows of plastic chairs, having taken half a day off work to be there, leafing through dogeared magazines, well, they’re men.  A day when reproduction really is shared. I thought Logan put it best.  Logan: Having a kid should be like launching a nuclear missile from a submarine. You have two keys, and you have to put them in and turn them at the same time. Reproduction should be opt in for both parties. Both people in a relationship, in a dyad, are able to control their fertility, are able to contribute to the reproductive goals of that relationship. I think it’s kind of a noble idea where you could have true reproductive autonomy, where each member of a dyad has their own choice and has their own path forward, but they arrive at a shared conclusion together, and they either turn that key at the same time, or they decide not to turn the keys, together. Hattie, narrating: Thanks for listening to this episode of the Slow Newscast from Tortoise. It was reported by me, Hattie Garlick. The producer was Brenna Daldorph. Sound design was by Sam Mbatha. And the executive producers are Jasper Corbett and Ceri Thomas.  Read MoreRead less How we got here When we began to look into this story, we kept hearing about one medical trial for a male contraceptive that took place between 2008 and 2012. It was a big deal— it was the farthest a male hormonal contraceptive had ever gone in trial. Apparently, it was all going really well until, out of the blue, an oversight body made the decision to cancel it, citing side effects. But the reported side effects were all mild or moderate and involved things like a bit of acne or weight gain— side effects women on the pill have put up with for years.  The story that was reported at the time was that the trial was halted because men couldn’t handle these side effects. “Men are such babies,” comedian Michelle Wolf practically sobbed on the American satirical news programme, the Daily Show.  But the more we dug, the more we became convinced that men’s wimpiness wasn’t the real story of why this trial was cancelled. That feeling solidified when we spoke to men who had taken part in contraceptive trials, who were all really enthusiastic about the drug and excited about what it would mean for their lives and relationships if it was an option. We knew that if we could solve the mystery of why this trial was cancelled, then we might get an answer to our bigger question— why, more than sixty years after a women’s hormonal contraceptive appeared on pharmacy shelves, we still don’t have one for men. And, turns out, we were right. Brenna Daldorph, producer Past reporting ListenWatchRead

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Why this story? Among those who work in contraception, it’s a well-worn joke: a male pill has been just five years away from hitting store shelves… for the last 40 years. But for a long time, male hormonal contraception has been a niche subject. Contraception, it’s generally accepted, is women’s work. In 1961 Enoch Powell, then Minister for Health, confirmed in the House of Commons that “birth control pills” could be prescribed on the NHS. Today, around 3.5 million women in Britain – and 100 million around the world – pop a pill every day. It has rocket-fuelled gender equality, spurred the feminist cause. But recently, another side to the contraceptive pill has emerged.  It started with women airing gripes about the pill, and experimenting with other birth control methods instead. Cycle-tracking apps, for instance. Then, last summer, when America’s constitutional right to abortion was revoked, that rumbling discontent became a roar. It takes two to make a baby, so why are women still overwhelmingly responsible for birth control – for the admin, side effects, stress and, when it goes wrong, the very grim consequences?   Suddenly, the old joke about waiting five years for 40 years wasn’t so funny. So we set out to solve the mystery of the missing male contraceptive pill. Hattie Garlick, reporter Transcript Hattie Garlick, narrating: At first, it was just a low murmur of discontent.  I wonder if you heard it, too? If you’re a woman, anywhere between, let’s say 15 and 50, I bet you did. Women were complaining about the contraceptive pill, side effects they’d put up with since puberty, and would likely deal with till menopause. Suddenly everyone was trying out a period tracking app. Ads for ‘natural’ contraceptive methods kept popping up on social media. Then, last summer, when news broke that the US Supreme Court had overturned Roe v Wade, ending the constitutional right to abortion, that murmur rose into a roar.  In the words of one viral tweet: “If a woman has sex with 100 random men in a year, she can still only produce one full-term pregnancy. If a guy has sex with 100 random women in a year, he can produce 100 full-term pregnancies. So why exactly are we only talking about regulating women?” It takes two to set the wheels in motion for a pregnancy and a birth. But all around the world, birth control remains overwhelmingly the burden and responsibility of women. Right now, there are 15 different methods of contraception available on the NHS. Just two of these are for men: condoms and vasectomies. And more and more women are now asking, ‘Why?’ How come, way over half a century after the contraceptive pill for women was launched, we still don’t have an equivalent for men? And then, one night a couple of months ago, I was sprawled on the sofa, watching the comedian Phil Wang on Netflix. And something made me sit up: Phil Wang: “I’m very grateful to all you ladies actually, for being on the old contraceptives. On behalf of the fellas, cheers. Appreciate it. It’s not fair they have to do most of it still. It’s not fair that you ladies have to do most of it still. It’s not like male equivalents haven’t been developed. They came up with a male pill just a couple years ago. They came up with a contraceptive pill for men, but the test subjects found that it actually sort of altered their body chemistry. Made them feel a bit sad. So, they all went: “hmmm… must not be ready yet. Women can keep using their pill, which we presume is perfect by now.” Hattie, narrating: Could that be right, I wondered? Was the science for a male contraceptive in place, just not men’s willingness to take it? So, I started digging.  And I found it. An international trial, sponsored by the World Health Organisation, that was cancelled suddenly in 2011 because of side effects experienced by the male participants.  But as I soon found out, that isn’t the full story.   I’m Hattie Garlick and on this week’s Slow Newscast from Tortoise, one of the biggest inequalities in global health: The Missing Male Pill.  Emily Glastonbury: So, the relationship I had with contraceptives was not great… Hattie, narrating: That’s Emily Glastonbury. She’s 32 and lives on a peaceful street in the Manchester suburbs, with her husband Dan and eight-month-old son, Jack.  And well, finding the right contraception has been a trial for her. First, she tried the pill… Emily: You go on it, as a girl, you go on it so young, before your body has stopped growing, before you get in tune with yourself because you’re so scared of getting pregnant when you’re young and it’s all very much encouraged by your doctors. It took a while for me to find one that didn’t sort of give me migraines or make me have horrific mood swings, it took a while to tailor that…  Hattie, narrating: So instead, she decided to try the contraceptive implant, a thin, bendy rod that’s placed under the skin of your upper arm and it slowly releases the hormone ‘progestogen’ into your bloodstream. Emily: I’d had the implant in my arm, and it hadn’t agreed with me, and I had to get it taken out and I’d bruised from here to here when I got it put in in the first place…  Hattie, narrating: She got terrible cramps and migraines. So, she switched to yet another contraceptive, an IUD, that’s a small T-shaped device, it’s put into your womb by a doctor or a nurse.   Emily: I heard somebody describe the pain of getting an IUD put in as ‘seeing colour’ and I think that is so apt. It was the moment it went in, I could have vomited, it was so painful. I remember her talking, the doctor talking to me afterwards, and I couldn’t even like hear her. I could barely like see her, because I was just in… I was just in so much pain. Hattie, narrating: But as Emily tells it, it’s not just a physical toll that contraceptives can take on you, it’s a mental load as well.  Emily: It is a heavy responsibility. It is like something that you have to constantly be thinking about like, have I taken the pill? How many have I got left? I was actually thinking the other day, I won’t ever get back those many, many hours I sat in walk-in clinics when I could have been… I could have been doing anything with those days. I could have been furthering my career, I could be playing a sport, I could be doing all of the things that men get to do on a day-to-day basis without even thinking about it.  Hattie, narrating: We’ll hear more from Emily and her husband Dan a bit later. But for now, she’s a sort of every woman. Because, sure, plenty of women love their contraceptives but Emily’s experience is far from rare. So, if there was a chance that there was another option out there, a way to share the burden with the men in our lives, I really wanted to find out why it wasn’t available yet. Richard Anderson: So, it’s always been a rather niche area, hasn’t it? But actually, it touches everybody, contraception, pretty much sooner or later. And so, it’s just got, you know, universal appeal. Hattie, narrating: That’s Professor Richard Anderson. He’s one of the world’s leading experts in male contraceptive research, he has been involved in a lot of ground-breaking trials over the past three decades. Including the trial I think Phil Wang was referring to: one that ran from 2008-2012, sponsored by the World Health Organization.  So, on a wet, moody morning, my producer Brenna and I caught an early flight to Edinburgh. Turns out, it was World Contraceptive Day and, that week, an anti-abortion group was holding protests outside of Edinburgh clinics that offer abortion services.  But at the Queen’s Medical Research Institute, where Richard is based, the calm was almost church-like. In his office, yellow files house decades of research. On the wall, beside a diagram of the male reproductive system was a child’s drawing of weather patterns— clouds, sunshine and lightning depicted in poster paint and glitter. The date on the picture said 2000, appropriate for a field that seems to have moved so slowly.  Richard: It hasn’t been fast, has it? You’re talking many decades since people first thought of this idea, and we still don’t have a product which is really pretty embarrassing isn’t it? Hattie, narrating: Richard has a slide dating back to the 1930s. It shows how when a man takes doses of testosterone, his sperm count drops, and then it bounces back again once he stops. But by the early 2000s, researchers were working with a different recipe for a male hormonal contraceptive.  Richard: A combination of two different drugs that were given as separate injections in that trial, but theoretically in a future product could be mixed together to be in a single product.  Hattie, narrating: The two drugs are testosterone and progestogen, which is widely used in female contraceptives. Both of these can slow down the release of the hormones that stimulate sperm production. And giving them together seemed to keep side effects in check. Eventually, researchers were ready to launch a Phase 2 trial. That’s a big deal. It was the first large-scale trial to test whether this combo would be safe and, crucially, whether it would prevent pregnancies.  Ten study centres were set up all around the world: Australia, India, Indonesia, Chile, the UK, Germany. The first volunteer was enrolled on September 4, 2008 and, from his test centre in the UK, Richard started watching the results come in. Richard: It all seemed to be going very well. There were no major side effects, I don’t think anyone in the trial locally left the trial because of side effects. But some people feel a bit different undoubtedly on this type of hormonal contraception. Sometimes they feel an increase in libido, sometimes they feel a decrease in libido, sometimes a bit moody. Hattie: And were there side effects that surprised or worried you, or ones you might have predicted? Richard: No, these are ones you get routinely in these trials. Hattie: And there were some mood-related, again I suppose. Did the severity or the scale of those trouble you? Richard: Not at all, no. As I say, we didn’t have anyone who left the trial locally because of them in that study. You know, it was all going straightforwardly.  Hattie, narrating: In fact, 99 percent of all the side effects reported were mild or moderate. One volunteer did die by suicide during the trial, but the tragedy was investigated and found totally unrelated to the study. Plus, the vast majority of mood disorders happened at just one study centre. And the results were exciting. Out of the 266 couples who participated, there were just 4 pregnancies, or 1.57 pregnancies for every 100 users. That’s a better rate than condoms, which average around 2 pregnancies for every 100 users. So, yeah. It was all going swimmingly. And then in March 2011, two and a half years after the trial started, that suddenly changed Richard: I think we all got, all the investigators got an email from the organisers. Hattie: Out of the blue? Richard: Yeah…  Hattie, narrating: The WHO had made a sudden decision to terminate the trial early. Volunteers were transitioned off the drug. Everything was wound up by May 2012.  But it wasn’t until a few years later in 2016 when the reasons for the cancellation were made public.  A study about the trial specified that it was down to, and I’m quoting here, “reports of mood changes, depression, pain at the injection site, and increased libido.”  The press jumped on the story. And women across the world were livid.  Michelle Wolf: “Aww poor men couldn’t complete the birth control study because it gave you pimples and made you moody. You guys call that side effects? I call that day four of a fairy-tale period. Men are such little b*****s. I mean one of the side effects is increased sex drive. You men always end up winning. The shot may as well be called ‘More sex, less babies.” Hattie, narrating: That’s comedian Michelle Wolf on the US Daily Show. It’s the narrative about the cancelled study that took hold, and the story that’s been told about male contraception ever since. Richard: And that’s why you’re still bringing it up and every journalist continues to bring it up ad nauseum. It’s really quite tedious to be talking about it fifteen years later. Hattie, narrating: I think you can hear the frustration in Richard’s voice here. And frankly, I feel bad for stoking it, because I can completely sympathise. Richard has been chipping away at the challenge of developing a male contraceptive for decades. He’s weathered plenty of ups and downs in the field.  Yet this cancelled trial is the one moment that’s raked up, again and again. And it’s a narrative that’s damaged progress. Richard: ​​I mean, there hasn’t really been significant activity within WHO in the field since. But I think it was a serious negativity for ongoing research within the WHO and Conrad, the co-sponsors with them. Hattie, narrating: But I do think that this trial is worth talking about. Just not for the reasons everyone has focused on. For a start, this whole idea that it was terminated because men in the trial couldn’t, or wouldn’t, shoulder the side effects that women have been quietly carrying for half a century… Richard: That’s just not the case. 70-80% of both sexes said that they wanted to continue. Hattie, narrating: Actually, it was a WHO oversight panel, a body called the Research Project Review Panel, that made the call to terminate, not the male volunteers.  I wanted to speak to some of these volunteers, to get their side of the story. I got some leads, but no dice.   And then, I found something else.  Nannette Cardon: I had been on the pill previously and had started noticing some of the side effects that do come when people in my age bracket, which is mid-thirties, take the pill– decreased circulation in your toes and fingers and the usual weight gain, and like that. Hattie, narrating: That’s a producer reading the words of a woman called Nanette Cardon. Way back in 1988, Nanette and her partner Gary Pascoe participated in an earlier trial of a male contraceptive. They were living outside of Seattle at the time and Gary and Nanette were interviewed about their participation for a story on PBS NewsHour. There wasn’t any video of that interview, but I found a transcript online and we’ve had producers step in to read the words of Gary, Nanette and the journalist.  Gary Pascoe: We had definite problems with existing birth control, which kind of led us to the program that I’m in now. Journalist: Gary and Nannette tried other birth control methods, but she was allergic to them. Thus, Gary volunteered to take part in the injection study, to see if the experimental shot might be an answer. That was in September. The sperm count has remained at zero since, and Nannette has not become pregnant. Nannette: After all these years of being the one to take the responsibility, it’s really neat getting a rest from that.  Hattie, narrating: The interview really struck me, for a few reasons. First: Gary’s no misogynist. Way back in the 80s, he was willing to share the burden with his partner, just like, when you look beyond the headlines, the volunteer participants in Richard’s later WHO trial appear to have been. Actually, a 2019 YouGov survey found that one third of sexually active men would consider taking a male version of the pill, exactly the same as the percentage of women who currently use hormonal contraception. Nanette is also keen to trust her partner with birth control, something else Richard’s research supports. Back in the late 90s, he surveyed ordinary women at family planning clinics in Scotland, China, and in South Africa. Only 2% of them said they wouldn’t trust their partner to use it.   But most of all, I’m touched by the familiarity of Nanette’s story. She’s expressing the same frustrations that Emily did at the start of this podcast. But she was talking 34 years ago. What happened when her trial ended? Did she have to go back on the pill? And if an alternative didn’t arrive in her fertile life, will it happen in mine? Hattie: So, I’m nearly 40, I guess if I’m….  Richard: I don’t think you’ll need to be relying on this, Hattie. I suspect this will be for your daughter, rather than yourself. Hattie: And do you think you will still be in this field of research? Richard: I will have retired, for sure personally. Hattie, narrating: I left Richard’s office with a burning question– if the science has been there for a while, and men’s wimpishness or unwillingness aren’t actually the villains here, then what the hell is holding male contraception back?  Hattie: Look, I know Richard said not to fixate on that cancelled trial, but something about it is still really needling me. Brenna Daldorph: What’s bugging you? Hattie: I think it’s those oversight panels. Hattie, narrating: That’s me having a chat with my producer, Brenna. And here’s what we were discussing. And bear with me because this gets a bit into the weeds.  So, there were two different oversight organizations keeping an eye on volunteer safety during the terminated trial. In January 2011, the first, the Data Safety and Monitoring Committee, examined the latest trial data and decided everything looked good.  But in March, just a few weeks later, the second one, the just-as-snappily named Research Project Review Panel, or RP2, took a very different view. It chose to terminate the trial.  Hattie: Ok, so have a look at this, I just got an email from someone who was involved in the trial. They don’t want to share their name, but they’re really not holding back… Brenna: Okay let me read this, ‘It was a stupid and unjustified decision made by people not experienced in male contraceptive research and panicked by a few cases of depression. Just plain dumb.’ Wow. Hattie: Right? But I guess the question is, do we buy that it was just incompetence? I mean, this is the WHO right, it’s not like we’re talking about some amateur science club. Hattie, narrating: I contacted the WHO, but they couldn’t put me in touch with anyone who had been on the committee back in 2011, and saying, and I quote here ‘the deliberations of committees of this kind are not public’. Eventually, I tracked a member down myself, but they were equally unforthcoming.  So, I emailed the WHO back to ask, how did these two panels come up with such different conclusions? Did they look at different data, perhaps? Or approach it with different concerns?  Hattie: Right okay, so, I’ve heard back.  Brenna: Okay, read it to me. Hattie: So, hold on a sec, they say ‘The DSMB and the RP2 looked at the same data and used the same metrics in assessing the adverse events. However, RP2 felt that because the study had already demonstrated the efficacy of the drug in reducing sperm counts there was no additional benefits in continuing.’ Huh. Brenna: I am, like, so confused right now. What does that even mean? Hattie, narrating: It’s not unusual for scientists to interpret data differently, but everyone I spoke to told me that it was highly unusual and controversial for a DSMC’s decision to be overruled like this. I didn’t feel any closer to understanding why these two expert panels, looking at the same data, for the same things, came to such completely different conclusions about the study’s safety.  And then I found this, on YouTube: John Amory: “I want to begin with a little bit of background that maybe some of you know. That was the premature stopping of the WHO’s study using testosterone and norethindrone because of side effects. It really led the whole field, I think, to stop for a moment and consider the issue of adverse effects, and also the ethics of continuing studies, or doing studies, for male contraception. I think this project is the first step into addressing the issues that were raised…” Hattie: Come and have a look at this, I think this might be a major clue. Brenna: What is it?  Hattie: So, it’s a panel debate, and it’s being hosted by a non-profit called the Male Contraceptive Initiative, in North Carolina. Should we try and get them on the phone? Brenna: Yeah, let’s do it. Logan Nichols: I’m Logan Nichols and I’m the Research Director at MCI. I certainly remember trying to learn more about the field and being introduced to that trial very quickly. I do remember seeing a lot of headlines when that paper was produced about men not being able to handle the side effects. They cancelled the trial because these guys are wimps and couldn’t deal with the acne or whatever. So, I think that it really is a black mark on the public perception of male contraceptives and of men who participate in these sorts of trials and I think that the framing is often lost. Hattie, narrating: And here it was. The piece that finally made sense of the puzzle for me. It wasn’t about the risk itself, but how that risk was framed. I know that sounds wonky but hear Logan out. During male contraceptive trials, you are giving healthy young men a drug.  Logan: So, one of the ethical considerations for contraception is, with female contraception, you’re mitigating the risk of pregnancy, which, you know, in of itself is a health risk. These young men are not getting pregnant and so, what are you mitigating? What health risk are you mitigating?  Any sort of health risk, technically, is too much if you’re not mitigating any health risk at the other end. Hattie, narrating: In other words: different standards are applied to the side effects experienced by men trialling contraceptives. But not because men are wimpy. Because pregnancy is a risky business for women. Men, though, don’t get pregnant. So, the risk/benefit balance to the user is different. Any side effects are set against the alternative of just life as an ordinary guy. And I get this. My second child was born by emergency C-Section. And while it was terrifying for my husband, too, the risks that he and I faced in that moment were really different.  But, in trials of male contraceptives, this adds up to what Logan’s panel called ‘a singular ethical situation’. His colleague Carmen Abbey put it well during their discussion.  Carmen Abbey: “In clinical trials, when we’re looking at adverse events and potential side effects, there’s not really an outline for how to interpret how much risk is too much risk.” Hattie, narrating: This foggy risk landscape also makes it hard for pharmaceutical companies to justify wading in. Logan: I’d say it’s risk, overall. We’re giving a drug to young healthy people for a very long time. And I think that they consider that a risky proposition that means it has to be incredibly safe. The efficacy barriers are also really high. This is contraception, 80% success is unacceptable. They don’t want to put in the R&D money that’s required at the beginning to create a product that actually meets those bars. And, furthermore, they think about litigation. Hattie, narrating: And without pharma’s backing, it’s hard to imagine funding the Phase 3 trials that are needed way before a product can sit on the pharmacist’s shelf in Boots. Add in other factors— today’s regulatory environment, which is far more rigorous than it was back when the first female pill was in development— and, suddenly, I could see why it’s taken so long.  But I was also worried. Is that it, then? No hope? The end of the road?  Well, not exactly. Logan: That’s one of the reasons we pitched this idea called shared risk, we’ve written a paper about it. I think it’s a really cool way we can frame things for regulatory agencies, for developers, to try and just reframe that risk such that if you administer a contraceptive to a male partner, you’re mitigating pregnancy risk in the female partner and thus the sum total of the risk for the partners is less than it would be if a pregnancy were to occur. Hattie, narrating: Logan’s paper, penned with colleagues, is called ‘‘Shared Risk: Reframing risk analysis in the ethics of novel male contraceptives”.  And here’s what it proposes: the risks associated with pregnancy could be considered applicable to both partners in a couple— after all, it takes two. Suddenly, if you’re developing, or approving, a male contraceptive, your risk thresholds are much clearer. You don’t want the risk to be higher than those female contraceptives carry. But if your drug carries a risk that’s the same, or better, lower, than those attached to current ones, it would be justifiable, ethically, to give it to man because it protects the couple, jointly, from the higher risks of unplanned pregnancy.  And if all sounds fanciful, well, consider organ donation. We already let donors undertake the risk of surgery, to benefit someone else. But organ donation is altruistic. Male contraception, less so. Because, of course, men do have a personal stake in preventing pregnancies, just not in ways that clinical trials commonly measure.  Logan: Men benefit from contraception, let’s be very clear about that. I think that we need to do more studies on how men benefit from contraception, what their educational, economic outcomes are whenever they experience an unintended pregnancy. All of these are understudied, which I think, by really understanding that data, we’ll be able to, again approach contraception as a couple’s issue instead of an individual piece, in the appropriate cases. Hattie, narrating: In some ways, it’s a little closer to the reasons loads of parents gave for vaccinating their healthy children during the pandemic. The kids benefited personally from Covid protection, but the positives of herd immunity were also a big motivating factor. And actually, Logan suggests that there would be benefits for the ‘herd’ in male contraception too.  Logan: I don’t say this a lot, but in terms of what male contraception can do for gender equality, I think it could make better dudes in general.  I think that men can acknowledge their contribution in reproduction, their responsibility in family planning, and because of that, we end up with relationships that are more empathetic, equitable, more communication, trust, more understanding about the burdens we all face in determining our reproductive future. That’s step 30, and we’re on step 2 in terms of getting men and women in a partnership to be more on an equal footing. Hattie, narrating: The gender pay gap, the domestic load… I was starting to get excited about the subtle inequalities that might be rebalanced if this first step, family planning and birth control, was more shared more equitably too. If the other 50% of the population knew the horror of forgetting to take a pill just once, could it tip the balance of sympathy towards women who get pregnant by accident? And Logan gives me some hope. Because even if the medical research world isn’t ready to calculate risk in this shared way yet, there are signs that the rest of the world may be. Logan: I think the time is right just in terms of a social moment. We’re in a post #MeToo era, we have men who are questioning their own role in reproduction, men who are wanting to take a more committed role with their partners. This kind of societal shift in which men are seeing themselves as reproductive beings for the first time and I think that makes this really an opportune moment. Hattie, narrating: In a 2019 YouGov poll, eight in ten Brits said men and women should take equal responsibility for birth control. But what’s more interesting is that men and women were almost equally likely to take that view. And in the States, in the wake of the reversal of Roe v Wade, there are signs of new eagerness from men. Searches for and enquiries about vasectomies are up. Hits to the MCI website, too And if the market starts clamouring for male products, it could change the risk calculations for pharmaceutical companies, encouraging them to reinvest in trials.  So, are we at the tipping point? Is now the moment we finally get male contraception? Dan: We met in 2014, at Glastonbury festival. I saw her and the birds sang and the butterflies flapped and I saw her pretty red hair. Hattie, narrating: That’s Dan Glastonbury and the red-haired muse he is describing is his wife, Emily, who we met at the start, the one who described her terrible experiences with birth control.  Dan: I badly flirted by telling her how good her handwriting was.   Hattie: That’s a novel line!  Emily: It is a novel line, and he wondered why I didn’t pick up on anything for a while. Hattie, narrating: My producer Brenna and I are perched on a sofa in their small, light-filled sitting room, equally transfixed by their baby Jack, who’s sitting on the floor, playing with a basket of rattly toys and by their story. Because like so many women, Emily has had a difficult relationship with contraception. But unlike most couples, the Glastonbury’s decided to do something about it.  Just before the pandemic, Emily was online when she saw an ad. Couples in long-term, monogamous relationships were wanted, for a clinical trial, testing a male contraceptive. Emily: It was advertised on Facebook, I guess I was just like the target audience for that. And I looked into it, and I thought this looks interesting, and, you know, something that I always thought was missing from our lives was a male contraceptive. So I sort of put it to Dan, and you were quite keen, weren’t you? Hattie, narrating: The trial Emily stumbled across is a global one. It’s being run right now, by the Population Council and the National Institute of Child Health and Human Development in the States. And some aspects of it are going to sound familiar because the lead investigator here in the UK is Richard Anderson. And though the drug they’re trialling is a gel, not jabs, it’s made of testosterone and progestogen, the same two active ingredients that were in our council trial. It’s also the first male contraceptive to make it to a phase 2 trial since that one. But, back to Dan and Emily.  Emily: Yeah, I think I had to have a couple glasses of wine. Dan: She got drunk, signed me up on Facebook and then said: we don’t have to do it, but, I want us to do a medical trial where you take a drug that will reduce your sperm count. And I was like, alright, this a lot! Hattie, narrating: Totally understandably, Dan had a few reservations. Dan: There’s a fear of signing up to a medical trial, and I also think so much of the gender roles that are taught to you as a male are like your fertility is your manliness. So, the idea of science messing with your ability to reproduce, somewhere in the back of your brain you’re thinking it’s taking away what makes me a man. There was a bit of fear around that in the back of my head. Hattie, narrating: In the end, though, they decided to go for it. Dan had actually always wanted to participate in a medical trial, more on that in a moment. Oh and also, Dan: It turned out the hospital’s right nextdoor to my favourite donut place. Hattie: Deal done! Dan: Yeah, that really helped things. Hattie, narrating: They applied and then they went through interviews and medical examinations. Dan: We started in April didn’t we, the whole chit chat process, and it wasn’t till we went to Glastonbury in June that I was actually on the gel. Emily: And then I had to continue to be on contraceptive until, it was the September of that year, I think. Dan: My sperm count was 42 million, and to get someone pregnant, you need at least 5 million, so they wanted me to be less than a million. I had to drop from 42 down to less than 1, and once it stayed at less than a million, I think for two months, not months, two check check-ups, which is like every 3 weeks, they were like: alright, here we go! You’re going to go off your contraception, I’m going to stay on the gel and we’re not going to have a baby. That was the plan. Hattie: How did your day change when you were on the trial? Dan: Nothing, like any other person I have to get up for work, shower and brush my teeth, so all that happened was that in the middle, I whack some gel on my shoulders and in 30 seconds, it was dry. That’s it. That’s as difficult as it gets. Hattie, narrating: And for Emily, the benefits were unexpected… Emily: I just became really in tune with like how my body goes each month. There were goods and bads of coming off of it for me. I started getting bad PMS again, and that’s something that I didn’t realise was a part of me, because I’d been taking hormonal contraceptives for so long. It was crazy to be like, oh, okay that’s what my body does every month and I’ve just been suppressing it. Hattie, narrating: And then, after a year of using the gel, the trial ended for them. How did it feel? Emily: It’s an indefinite end, isn’t it? The responsibility is handed back over, indefinitely. Because we have no idea where this is going to go. It’s been nearly four years since we signed up initially. Dan: It’s a bit like the end of the film The Graduate, where they get on the bus and they’re like: it’s the end, what happens next? Oh god, I don’t know what to do now. You’re gonna feel like you’re thrown out into the wilderness. Give us back the gel! Fend for yourselves! You had a taste of freedom, smell you later… Hattie, narrating: But Dan and Emily had decided to try immediately for a baby, so they were excited. Dan’s sperm count rose quickly, and eight months ago, Jack was born. And Dan says that participating in the trial has actually had an impact on the way they parent together.  Dan: I feel like going through the sharing of the contraception definitely made me, I think it made me much more aware of how much Emily does and I take for granted. And maybe how much women do, that I took for granted. It’s very easy to be an ally as a male, but that doesn’t mean you’re still actually hauling 50% of the weight.  Hattie, narrating: Actually, for Dan, there was something else significant about taking part in this trial.  Dan: I’ve got a book of 101 things to do before you die, and one of those things is take part in a medical trial. I had cancer when I was 19, which is the reason why I now have the book. Cuz when I got the all clear, after a year of chemo and radiation therapy, my mom bought me the book as, like, you’ve got your whole life ahead of you. Do all the things you can. When I wanted to do a medical trial, I just wanted to tick something off a book and I tried signing up to all sorts of medical trials— I literally had no idea what they did— that in no way would have affected me positively. But this medical trial was the medical trial for me. Because it has helped me develop as a man, as a human being, as a partner, as a husband, as a father. I didn’t expect any of that. I just wanted to tick something off a book and make some money. And in the end, I’m a better person for doing it. And I feel like I’ve contributed to science and the wellbeing of other human beings. So, thank you NEST study. Did not expect to say that, I’ve never really considered it before but, yeah, it’s improved so many things in my life. Hattie, narrating: I wanted to know if Dan was a happy anomaly. How positive were the other trial volunteers about their experiences? So, I asked Richard Anderson about volunteer recruitment. And for someone who appears to guard his professional expectations carefully, you can hear the edge of excitement in his voice.  Richard: So, when we started it was extraordinarily positive. We got masses and masses of phone calls, lots of couples came forward. It was going very very well, and, again, a lot of interest actually. It’s been really not difficult to find couples to do this.  Hattie: Do they share their motivations with you? Richard: Yeah, because we always ask why, and their main motivation is being fed up with there only being female methods around basically. Hattie: And the data that’s coming out of the trial, what’s that telling you about the efficacy of this method? Richard: Well, we don’t have final data obviously as yet, but it’s been amazingly successful. Hattie: I get the sense that you’re trying to kind of stay level-headed and not get too excited. Richard: Yeah, there’s a lot still to come. But I am amazed. I thought we’d get lots of pregnancies in this trial to be honest. Because, as you say, it’s very easy to forget to put the gel on and you know there was a worry that if you did, your sperm count would be bouncing back straight away, but that absolutely has not happened. Hattie, narrating: Efficacy rates appear to be better, even than for the pill. Exit interviews show that some women don’t want to return to female contraceptive methods and loads of couples have asked if they can re-enrol, just to continue taking it.  Actually, the results are so good that the study sponsors are already writing a protocol for the next step, a Phase 3 trial. That would be the furthest a hormonal male contraceptive has ever gone in trial. Uncharted territory. And so… this is the bit I don’t want to say. I’m loath to disappoint— or maybe you’ll breathe a secret sigh of relief, who knows. But that Phase 3 trial will likely need funding from a pharmaceutical company. And though there is hope of reawakening interest, for the time being, they still aren’t dishing out the dollars. The Male Contraception Initiative, where Logan works, told me that, in the last decade we’ve got data for, pharma’s total investment in male contraception was equivalent to just one third of a top paid pharma CEO’s annual salary. Even with funding, a phase 3 trial could take up to five years to complete and then come regulatory hurdles. The sponsors of the gel trial are hoping to meet with US regulators before this year is out and get some answers. But for the moment, no one knows quite how the FDA and other regulators are going to measure the risk/benefit ratio in a male contraceptive. So where does that leave us? The appetite is there, from men and their long-term partners, the science seems ready, the political environment primed. But the product? It’s still a long way off.  And for that reason, everyone I’ve spoken to for this story, while raving about its potential to change the world, they’ve discussed those benefits in terms of their children.  Dan hopes Jack will one day have the option of taking it, he’ll encourage him to, he says. And when I speak to Logan one last time, it turns out that his wife is about to be induced, the very next day, with their second child. He already has a son: Logan: He’s 4 years old, and so chances are—let’s just hand wave and say we’re 10 years away from the male contraception actually hitting the market— he will be among the first generation of users who have an option, or even more than one option, available to them as he becomes reproductively active. That’s something I think about a lot in terms of my kid and now my kids, and how we can create this equitable reproductive world that helps them. Hattie, narrating: In the current environment, with reproductive rights eroding and expectations for more gender parity rising, the knowledge that a male contraceptive won’t happen soon is a hard pill for many women, and some men to swallow.   But I started this story imagining that it might be about misogyny. In the end, it’s about risk. It’s about the risks that women have taken on for half a century. About the risks men are prepared to take to share that burden, but even more so, how the industry looks at risk. But it’s also about the risks we face if we don’t take those leaps. The risks of strangling reproductive rights. The risk of widening those inequalities of opportunity that stretch far beyond the moment a pill is popped or a gel is applied, into the future of our families, our workplaces and societies. Actually, we may not have true gender parity till one day, you walk into the family planning clinic and half the people sitting in those rows of plastic chairs, having taken half a day off work to be there, leafing through dogeared magazines, well, they’re men.  A day when reproduction really is shared. I thought Logan put it best.  Logan: Having a kid should be like launching a nuclear missile from a submarine. You have two keys, and you have to put them in and turn them at the same time. Reproduction should be opt in for both parties. Both people in a relationship, in a dyad, are able to control their fertility, are able to contribute to the reproductive goals of that relationship. I think it’s kind of a noble idea where you could have true reproductive autonomy, where each member of a dyad has their own choice and has their own path forward, but they arrive at a shared conclusion together, and they either turn that key at the same time, or they decide not to turn the keys, together. Hattie, narrating: Thanks for listening to this episode of the Slow Newscast from Tortoise. It was reported by me, Hattie Garlick. The producer was Brenna Daldorph. Sound design was by Sam Mbatha. And the executive producers are Jasper Corbett and Ceri Thomas.  Read MoreRead less How we got here When we began to look into this story, we kept hearing about one medical trial for a male contraceptive that took place between 2008 and 2012. It was a big deal— it was the farthest a male hormonal contraceptive had ever gone in trial. Apparently, it was all going really well until, out of the blue, an oversight body made the decision to cancel it, citing side effects. But the reported side effects were all mild or moderate and involved things like a bit of acne or weight gain— side effects women on the pill have put up with for years.  The story that was reported at the time was that the trial was halted because men couldn’t handle these side effects. “Men are such babies,” comedian Michelle Wolf practically sobbed on the American satirical news programme, the Daily Show.  But the more we dug, the more we became convinced that men’s wimpiness wasn’t the real story of why this trial was cancelled. That feeling solidified when we spoke to men who had taken part in contraceptive trials, who were all really enthusiastic about the drug and excited about what it would mean for their lives and relationships if it was an option. We knew that if we could solve the mystery of why this trial was cancelled, then we might get an answer to our bigger question— why, more than sixty years after a women’s hormonal contraceptive appeared on pharmacy shelves, we still don’t have one for men. And, turns out, we were right. Brenna Daldorph, producer Past reporting ListenWatchRead