Bitter pill

 

The pill is a burden for women. New contraceptives for men exist, however they never make it onto the market – why not?


If I had known at sixteen that I would be writing this text at thirty-three, I would have tried to stop my older self from doing it. Because I would have been so embarrassed. We were teenagers, everything embarrassed us. Especially everything that had to do with sexuality. Still, my friends and I had to go to a gynaecologist, tell this stranger that we were now having sex with a boy and needed something to avoid getting pregnant. And then we even had to let this stranger look inside our most private parts down there. Since that first visit to the doctor, we took responsibility for contraception as a matter of course. Because we were ashamed of it, we did it as quietly and invisibly as possible, and therein ultimately lies the whole tragedy. 

 

We never asked ourselves why the boys didn't have to go to the men's doctor to get prescribed things that would prevent them from making babies. That was simply our job. Television broadcasted reality TV formats about teen mothers, that was our threatening backdrop. 

 

For more than ten years I took a little pill every day. So did almost all my friends. Our gynaecologists promised us sexual freedom, less period pain, better skin – and no babies. We didn't ask any questions, had the little pills prescribed for us, which from then on, reminded by our mobile phone alarm clocks, we shamefully shoved into our mouths every day. 

 

What the gynaecologists didn't mention to us were the depressions, weight gains, declining libido, thromboses and pulmonary embolisms that the pills could trigger. Or that our risk of cardiovascular disease would increase twenty to sixty-seven-fold if we took the pill and smoked. We had to find that out for ourselves. We gained weight, sometimes had too little desire for sex in the eyes of our boyfriends and struggled with mood swings – during puberty it was difficult to identify all of this as side effects. We just changed to a different pill, with pink flowers instead of green ornaments on the package and a free make-up mirror. And the pill alarm clock rang every day. 

 

I stopped taking the pill in my late twenties. So did almost all my friends. Because we had enough of the pill alarm clock, the side effects and the artificial pill bleedings that have nothing in common with the natural period. Since then, we've all tried different kinds of things and have taken the morning-after pill several times. Since then, the fear of getting accidentally pregnant has returned. Due to this, we have taken many pregnancy tests. For those who don't know: the result window looks exactly like the one of the Corona self-tests, only waiting for the colour to pass is much worse. Because at two lines you know for sure: your life will never be the same again. Either you will then become a mother, or you will abort and thus become, in the eyes of many, such as the Catholic Church, a person who hires a hitman – Pope Francis really made that comparison. 

 

With this in mind, I had a copper IUD inserted. Beforehand I had to swallow a pill that expanded my cervix, it gave me pain in my lower abdomen and made me feel sick. The insertion also hurt, and on the way home afterwards, I had trouble not to throw up in the subway. The IUD made my periods much heavier and more painful. I now jestingly talk about my "slaughtering days", although it's not actually funny. But I put up with the blood and the pain so I wouldn't have to be afraid anymore. 

 

And after all this, the pregnancy test still showed two lines. It was the beginning of an ordeal. In the days and weeks that followed, I was examined by so many doctors that I can't even tell the exact number. After countless ultrasound scans, blood tests and differing diagnoses, they discovered that I had not simply become pregnant, but that the egg had lodged in the wrong place, namely in the fallopian tube thus making it an ectopic pregnancy. If it grows too big there, the tube bursts and you can bleed to death. 

 

I was injected twice with the cell poison methotrexate, it was supposed to end the ectopic pregnancy. It caused headaches and nausea. It didn't work, twice. I was in and out of hospital, the more time went by, the bigger the egg grew and the more pain I had. I would notice the bursting of the fallopian tube by even stronger pain, the doctors said, and from then on I wouldn't have much time to get to the hospital either. One doctor wanted me to sign a document releasing the hospital from any responsibility in such a case. I became afraid – no longer of a change in my life, but of its end. 

 

When the cell poison was unsuccessful, I had to have an operation. The egg that the doctors then cut out of my body had already grown to the size of a two Euro coin. I spent a total of eight days in hospital, no one was allowed to visit me because of the pandemic. The nurses had to take blood and put in catheters so often that they had trouble finding free spots on my arms. It took me weeks to fully recover. Now I have one fallopian tube less and three small scars on my belly. 

 

According to the German Association of Gynaecologists, the copper IUD has a Pearl Index of 0.4 to 1, which means 0.4 to 1 in a hundred women get pregnant with this contraceptive method every year. In 2020, I was one of these half to whole women. Whether the IUD encouraged the ectopic pregnancy was not possible to clarify. 

 

Why am I telling you all this? Because I want you to ask yourself the same question I did: Why is contraception still such a big problem – and why is it only women's? 

 

 

"Our sexuality was dominated, if not overshadowed, by the fear of an unwanted pregnancy. You can't even imagine that today. You could never be thoughtless, you always had to consult your calendar before sleeping with a man." This statement is from one of Europe's most famous feminists, Alice Schwarzer. And the following statement is from a press release by the German pharmaceutical company Bayer last year, captioned with the line "60 Years Empowering Women": "Nearly six decades ago, the first birth control pill made it possible for women to gain control over their own bodies in an unprecedented way. For the first time, it was possible to prevent pregnancy by taking a hormone preparation manufactured by Schering (now Bayer). This revolutionary method of family planning became a key factor in emancipation and a turning point for society."

 

That reads like a success story at first. Alice Schwarzer and her fellow campaigners fought for universally accessible, safe contraceptives and legal abortions with impunity because there was neither – or rather, there is. Abortions are still regulated in the German Criminal Code, and they are punishable by up to three years imprisonment or a fine if the pregnant woman does not make use of compulsory counselling. And contraceptives are still not safe – neither in preventing pregnancies nor in terms of their adverse effects. And yet after the first pill, many other contraceptives were introduced into the market: a second, third and fourth generation of pills, hormone rings, coils and shields, copper coils and chains or hormone implants for the upper arm, to name but a few. They all have one decisive feature in common: they can only be used by women. The promise of sexual freedom has become a coercion, because it has nothing to do with emancipation to be forced to take dubious contraceptives because there are none for men. 

 

How is it possible that there seems to be no limit to the imagination when it comes to female contraception, while we can't think of anything for men except putting a bag over their penis or sterilising them by cutting the deferent duct? The first record of condom use is believed to be a 14,000 years old cave painting in the Dordogne region of France, which is quite some time ago. Since then, condom technology has been refined quite a bit, but condoms still have a Pearl Index of only 3 to 15, which means that up to 15 out of every 100 couples who use condoms get pregnant. In a representative survey on contraceptive behaviour by the German Federal Centre for Health Education (BZgA), 46 percent of the women and men surveyed said they use a condom. Wouldn't it be about time to offer the remaining 54 percent an alternative?

 

Jana Pfenning and Rita Maglio, two Berlin students, are demanding this with their petition "Better Birth Control"; they have already collected over 125,000 signatures. They refer to the Sustainable Development Goal 3.7 of the United Nations, according to which "universal access" to contraceptives should be guaranteed by 2030. "Universal" means for everyone, including men. 

 

 

One assertion holds up adamantly: that it is simply too complicated to develop contraceptive methods for men. At the German Südwestrundfunk, for example, I read: "With women, you only have to make sure that ovulation doesn't occur once a month. With men, on the other hand, you have to stop many millions of sperm – every day." That's like saying it's much more difficult to shut down a button factory, because you have to stop the production of every single button, than a tank factory, because far fewer tanks are built there in the same amount of time. Yet all you have to do in both factories is cut the power. 

 

Translated to humans, that would be the hormone signals. The production of millions of sperm can be countered in a similar way to ovulation, not with estrogen, as in female contraception, but with testosterone. "If you give that artificially, it sends a signal to the pituitary gland that there is enough testosterone. The pituitary gland then no longer releases signal substances for testosterone production, because the testicles apparently produce enough of it. Sperm production is linked to this, so it is shut down at the same time," Michael Zitzmann explains to me. He is an andrologist at the Centre for Reproductive Medicine and Andrology (CeRA) at Münster University. However, testosterone alone is only 75 percent effective. That's why gestagen is added, which completely suppresses sperm production. 

 

"This is actually exactly the same as the pill for women," says Zitzmann. And he knows that this combination works very well because he himself administered it to 56 men over several months. The 56 test persons in Münster were among 400 men worldwide who tried out the contraceptive as part of a study by the World Health Organisation (WHO) and the US non-profit organisation Conrad. This went back to the WHO's 1971 plan to slow down the growth of the world's population. At the time eleven working groups set out to find a solution – only one of them looked for it among men. Michael Zitzmann's predecessor at CeRA was part of this working group, and when he retired, Zitzmann took over his task. "The 'male pill' works, in four or five years it can be on the market," he said at the time. That is now more than ten years ago.

 

The 'male pill' was in fact an injection because taken orally, the liver would convert the hormones into estrogen, and that would stimulate breast growth. With the injection, that doesn't happen; in the study, it was injected into the gluteal muscle every two months. "I was confident that this would be the last study," Zitzmann recalls. The Pearl Index was better than that of the female pill, of the 400 couples who took part, only four became pregnant – that was considered very good. But ten percent of the men complained about adverse effects such as mood swings, a changed libido or weight gain. Zitzmann remembers four men with severe depression – that was considered very bad. The study was stopped prematurely. "I was also in favour of it," he says. 

 

You are now welcome to turn back to the beginning of this text and compare the side effects of the pill for women with those of the injection for men. They are the same, except that the percentage of those who suffer from them is significantly higher in women. In the aforementioned survey on contraceptive behaviour by the BZgA, 38 percent of women who used the pill agreed with the statement that the pill has negative effects on body and soul. And a study by the University of Copenhagen from 2016 established a shocking connection between hormonal contraception and depression: women who took a classic combined pill consisting of estrogen and gestagen were prescribed antidepressants 23 percent more often than women who did not take the pill. With the minipill, which only contains gestagen, this figure is 34 percent. And for non-oral hormonal contraceptives – such as rings, patches and umbrellas – the risk increased threefold. 

 

The risk of thrombosis also increases instead of decreases with new hormonal contraceptives. According to a risk assessment by the European Medicines Agency and other European authorities, two out of 10,000 women get a deep vein thromboembolism every year. This means that a blood clot forms in a vein, fragments of which can break off and travel to the lungs, which can then lead to a pulmonary embolism and death. With each generation of pills and the new products such as patches and hormone rings, this risk increases: up to nine to twelve in 10,000 women. In addition, the drugs also increase the risk of arterial blood clots, which can trigger strokes or heart attacks. Nevertheless, the official verdict is: the benefit outweighs the risk. 

 

I ask Michael Zitzmann whether there was also an increased risk of thrombosis with the injection for the man. He denies. "The adverse effects for men and women could have been considered together. There is a double standard, which is really not quite correct," he admits. "The injection could well have been put on the market."

 

So why not? I ask the WHO and Conrad, which is funded by the US Agency for International Development, why the trial was stopped because of so few side effects and whether work is being done to refine the injection, as was suggested at the time. I learn that those involved in the study are now retired and no longer want to comment on it, a former Conrad employee tells me that research into the injection is no longer being pursued. And then I get another response from James Kiarie, WHO's department head of contraception and fertility care: "The only information we have on why the study was stopped prematurely, is that it was stopped for these reasons." What exactly he means by "these reasons" remains unclear. 

 

Michael Zitzman gives me another explanation: when the pill for women came on the market in the sixties, the acceptance of side effects was much higher. "If the female contraceptive pill were to come on the market today, it would most likely not make it through," he says. He explains the fact that new hormone preparations for women are constantly coming onto the market with simplified approval processes, because they are not completely new products.

 

 

One simple reason why there are still not more contraceptives for men is money. The calculation is quite simple: if a company launches contraceptives for men, the market for women could collapse at the same rate. And this business is far too lucrative to jeopardise. A monthly pack of the pill costs up to about 25 euros, hormone or copper IUDs cost 350 to 450 euros including the insertion. In Germany, contraceptives are not covered by health insurance except for exceptional cases; women bear the costs and risks alone. For my boyfriend, it went without saying that he paid half the price of my IUD. I doubt that it is the same for all men whose partners take care of contraception. 

 

Global market leader Bayer earned €1.75 billion in 2020 from its hormonal IUDs Mirena, Kyleena and Jaydess as well as its pills YAZ, Yasmin and Yasminelle alone. The product groups rank third and fifth among the company's top-selling pharmaceutical products. In addition, there is a broad product range of the subsidiary Jenapharm. To keep the business so profitable, the pharmaceutical companies send representatives to doctors' practices, send out free information material and sponsor further training – with great effect. In Germany, the Consumer Advice Centre Hamburg audited the contraceptive advice of gynaecologists in 2016 and gave three-quarters of them the marks D and U, because: "Too often, gynaecologists referred to the pill as the ideal contraceptive and did not inform about alternatives with fewer side effects."

 

It was also the pharmaceutical company Bayer that ended the last research on male contraceptives by the pharmaceutical industry, as far as we know. The Schering AG conducted this research up until 2007: in clinical trials, they tested a combination of a gestagen implant, which had to be inserted into the upper arm once a year, and a testosterone injection, which was injected into the gluteal muscle roughly every three months. But then Bayer took over the Schering AG and stopped the research shortly after that. 

 

I want to learn from the company why, but "due to previous experience with interviews on the subject" Bayer refuses to talk. In writing I get this explanation: "The combination of implant and injection has indeed been shown in the clinical studies to be effective and with a tolerable side effect profile. However, because of the unpleasant application regimen, Bayer was not convinced that this combination would be sufficiently accepted by men."

 

I have also told you my story in such detail and with all the side effects so that you now find this answer as hard to take as I did. And the Bayer company is also aware of the – to stick with the wording – "unpleasant application regimen" of female contraceptives: around 10,000 women have already sued Bayer in the USA for thromboses and pulmonary embolisms triggered by contraceptives, the company paid more than two billion dollars in settlements. Some 3,500 women sued the company for injuries caused by the hormonal IUD Mirena. I ask Bayer whether such cases would not make research into contraceptives for men more urgent, the answer is curt: "Bayer is not pursuing the development of contraceptives for men and cannot comment on this."

 

 

On the other hand, beyond the pharmaceutical industry there is a whole range of research projects on contraceptives for men. In India as well as in the USA, a reversible mechanical solution is being researched under the names RISUG and Vasalgel: a sieve-like polymer gel is injected into the deferent duct and traps the sperm there while the rest of the seminal fluid can flow through. If then men at some point no longer want to stop the sperm, they can take a drug, and the gel dissolves; the clinical trials are promising. The US company Eppin Pharma is researching the hormone-free drug EP055, which destroys a protein on the surface of the sperm and thus impairs their ability to swim. So far it has only been tested on monkeys. 

 

A more unusual invention comes from France, where the Thomas Bouloù collective developed the Slip Contraceptif. These are underpants that push the testicles with a ring into the abdomen and warm them there so that they no longer produce sperm. However, the underpants have to be worn for 15 hours a day, they are supposed to work after about three months. And another invention is even supposed to enable men to decide at the push of a button whether they want to be procreative or not. The Berliner Clemens Bimek, now living in Switzerland, invented a valve for the deferent duct that can be opened and closed with a flip switch. So far, he is most likely the only one wearing the device; he didn’t find enough funding for clinical trials yet. 

 

Michael Zitzmann's hopes rest on a hormonal gel that men rub on their shoulders every day. Primary small studies have shown good efficacy, now a clinical trial with several hundred test persons worldwide is underway. Maria Cristina Meriggiola, one of the participating doctors from Italy, tells me: "The men like it very much." Whether the gel eventually makes it to market will ultimately be decided by money. In a podcast by the US Male Contraceptive Initiative, Scottish study participants James and Diana talk about their experiences with it. The fact that James now uses the gel contraception for the couple made Diana feel as if a burden had been lifted off her, she says. "It is a shame that this has an endpoint. Then we will have to have a conversation again and go back to our lack of options," she says. The vast majority of couples who participated in male contraceptive trials would have liked to continue with them. Also in the WHO study, more than 75 percent of participants would have continued with the injection if they had had the choice. But they didn't have it, and they won't have it for the foreseeable future. 

 

We won't be able to change the fact that we women have to endure the consequences when contraception goes wrong. Maybe I would still have gotten pregnant in the fallopian tube if my boyfriend had used contraception and not me. But if he had had the choice, I might have been spared a lot of anxiety, mood and weight swings, pain and "slaughtering days" in my life. At worst, instead of me, my boyfriend would have had to deal with that at times, at best he wouldn't. That's called equality and should provoke more than just uneasy silence in the year 2021. 

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