Where Is The Male Contraceptive Pill And Why Is It Taking So Long?

This year, the UN theme for International Women's Day is "innovation and technology for gender equality". Taking this as a starting point, woo sets out to ask how new technology could stand to improve the fight for gender equality across the most intimate parts of women's lives.

In the 1950s, scientists in America set out to do something that would revolutionise society, health, autonomy, and wellbeing. The team, led by Bostonian biologist Dr Gregory Pincus, wanted to see if we could control one of the core elements of life: fertility. The idea being that if we can manipulate the ability to conceive, we can decide whether we would like to have sex without the chance of pregnancy. At the time, the focus was on developing a contraceptive pill which people who could get pregnant would take. Eventually, they developed medication that would disrupt hormones in such a way that the body wouldn’t ovulate.

The research gained positive reception from notable women’s rights campaigners at the time, including Margaret Sanger. Sanger opened the first birth control clinic in the USA all the way back in 1916 and was actually arrested for creating and distributing a pamphlet about family planning methods around the same time. Sanger, despite a complicated legacy (she was an advocate for some forms of eugenics, particularly around poor people and whether they should have children) she is and certainly was an instrumental figure where debate around being pro-choice on conception is concerned.

By December 1961, ‘birth control pills’ would become available via prescription on the NHS for the first time. So for the last 62 years, we’ve increasingly had access to methods of contraception that can help us minimise the chance of pregnancy in the event that a condom breaks, or isn’t there. Heady nights of meeting someone, knowing you want to spend the night with them and doing so could become a little more spontaneous, and a little less risky. In monogamous relationships where both people were free of STIs it could allow sex without a condom for pleasure reasons. But the contraceptive pills we have are far from perfect.

The most popular contraceptive pills used today are Microgynon, Rigevidon and Ovranette. Common side effects include headaches, breast tenderness, mood swings, and spotting. In rare cases (one in three thousand people per year) people develop a blood clot. The risk of this is more significant if you have a history of thrombosis. Raised blood pressure is a concern, too. Research also suggests hormone-based contraception can be linked to mood disorders. A study from the University of Copenhagen suggests an increased risk of depression in people who take ‘hormonal birth control’. The same symptoms exist with the coil, implants, and all other forms of contraception that target hormones.

There’s still no contraceptive for people who produce sperm that has passed clinical trials outside of condoms and vasectomies, hormonal or otherwise. Despite claims of being 98% effective when used perfectly, studies suggest that condoms are actually more like 87% effective in reality due to factors like putting the condom on only part way through sex (or taking it off before finishing) not looking for damage before use, and not leaving space at the tip of the condom for semen. This means that they’re ineffective more than one in ten times. A vasectomy involves cutting or sealing the tubes that carry sperm. The initial side effects include bleeding and clotting, possible infection, pain, and swelling. The treatment is permanent unless reversed, which is difficult to do. While a vasectomy can be done on the NHS in the UK, a reversal will set you back thousands.

Given that people who can get pregnant can take a pill that is in theory very effective against pregnancies, the burden to do so tends to fall on them. This is partly due to historic attitudes. “There's the inescapable biology that it is the female who's going to get pregnant, and therefore, no one would have started contraceptive development by saying: we must target men before we target women.” Says Professor Richard Anderson, who is working within clinical trials on a hormonal male contraception. But it’s also to do with who made up the majority of scientists then and now: men. But it isn’t all bad news. There might be a new wave of contraception on the horizon that changes things, and one study looks particularly promising.

On February 14 this year, a team from Weill Cornell Medical College, led by Dr Melanie Balbach published an article about an ‘on-demand male contraception’ that they are developing. The findings explain that they have proof of concept for a birth control pill that people who produce sperm could take “shortly before sex, only as needed” as opposed to taking a pill for 21 consecutive days as per most orally-taken contraception. Moreso, this new pill is a non-hormonal form of contraception, and potentially has virtually no side effects. The way the pill works is that it targets a specific protein within the sperm called soluble adenylyl cyclase (sAC), to temporarily stop the sperm from being able to swim. This means no hormones are targeted, nor affected.

This is initially very promising and very good, but societally there are complications. Contraception in use at the moment has serious side effects, as mentioned earlier. For over 60 years women (and people who get pregnant) have had to risk health complications to become temporarily infertile in order to have sex, whilst Balbach’s new pill means that men (and those who produce sperm) might never have to face the same risks.

This may seem unfair but Dr Balbach explains that “it’s reported in a way where men are blamed, but it’s to do with risk. When you develop a female contraceptive, you always weigh the risk of a pregnancy, which can be significant, to the risk of a side effect.” Kevin Shane, communications director for Male Contraception Initiative elaborates. “Because sperm-producing people cannot physically carry a baby, there is no physical risk from a pregnancy. But if you are an egg-producing person, the risks are significant. Up to and including death. Because this physical risk is higher, the affordance for side effects is too.”

In essence, a pill can stop a woman and other people who produce eggs from having to go through pregnancy – which can have health risks and complications, so side effects are seen to be worth the result. With men and other sperm-producing people, there are no physical risks to ejaculating, so giving them something that has side effects isn’t deemed to be worth it.

Of course, this way of thinking about risk is outdated. Pregnancies are safer than they used to be, for one, and also risk extends beyond physical factors. “Pregnancy can change the entire trajectory of your life,” Shane points out. There are also financial risks, and beyond all, risk shouldn’t really be the calculation, choice should. And we should be able to choose without severe side effects.

But that is why we don’t have male contraception just yet. These factors make getting a male contraceptive pill onto the market incredibly tricky. Essentially, most hormonal methods, which are generally further along the line because we’ve been looking into them for longer, Professor Anderson says, are unlikely to be approved for men if they are shown to have a form of effect on the entirety of the hormones in the body, because that side effect far outweighs the physical health risks on them if they don’t take it (which are basically zero). But now, we have a non-hormonal method which might just make it. And there’s more. Dr Balbach lets us in on some potentially very exciting information: this non-hormonal contraception they’re developing might actually work on everyone.

“We actually think people who get pregnant can take this pill as well. We're working on a female version of this. I did a publication in 2018 proving that you can stop sperm swimming in its tracks – so we might be able to use this contraception to do just that in the people who get pregnant.” Says Dr Balbach. However, she adds that the contraception might have to be a suppository(!) or just generally different to the ‘male’ one they are currently seeing promising results with.

That isn’t the end of the story, though. “The reason we don’t have male contraception is not the lack of science, it’s not the lack of demand, it’s down to a lack of funding.” Says Dr Balbach.

Getting from lab study to widely available medicine that you can buy over the counter at a pharmacy is a lot of work, and a hell of a lot of money. A billion dollars is the rough figure Dr Balbach, Dr Anderson and Shane all offer up. For Dr Balbach to have conducted the test in mice, it has taken four years and five million dollars. She anticipates, if all goes well and funding is secured, it’ll take another eight years before this pill is on the market. But it’ll take another five million [dollars] before they can even begin to think about testing on humans.

Male Contraceptive Initiative is the biggest donor of funding toward non-hormonal birth control research and development, outside of the federal government, in the United States. There’s only five employees, and Shane is one of them. “We’re only able to put about $1.2 to $1.5 million a year into labs to research these methods. It’s a very important step forward, but it's also a very small drop in a very, very large bucket.” He says.

The bulk of funding is usually provided by the pharmaceutical industry. They incur the cost of development, and eventually, if the product makes it to market years later, they will then make the money back (and more). The ‘if’ in this sentence, is massive. The way a pharmaceutical company sees it, “If they invest a billion dollars into a therapeutic and it doesn't make it to market, that is a big loss on the financial report.” Says Shane.

In essence, any possibility that a product won’t make it to market because of side effects, or a lack of proof, and good luck getting funding. What this means for contraception is, these industries are waiting for the perfect pill for sperm-producers to take. For people who can get pregnant, an improvement on the existing contraception is plenty to warrant funding. Sadly “If ‘Big Pharma’ is not going to get involved, we're going to be denied these products.” Shane says.

The sAC-inhibiting pill that Dr Balbach and her team are creating is only one study, in one lab, by one team focussed on one single idea and solution. There are other people trying to make other forms of contraception, both hormonal and non-hormonal. Professor Anderson mentions that the trial for a hormone-based gel called Nestorone (also known as NES/T) which has been very successful so far, for example. Couples are trialling the contraceptive over the next two years to see how effective it is, and what the side effects are. To use Nestorone, men rub it on their shoulders and chest daily, after three to four months, sperm count is low enough that it’s virtually impossible to impregnate someone, says Professor Anderson. By not taking the gel, sperm levels will begin to build up again, so it is reversible.

Scientists are out there trying to solve the problems the world faces. Dr Balbach says “I don't believe that we should be the only thing that's on the market, we really hope that there will be a plethora of options. Hormonal if someone wants it, say for instance men want to bring their sperm count down, if someone likes our on-demand approach, take that. If someone is truly done with having kids – have a vasectomy.”

People are trying to undo decades of bias, of inequality around the burden of unwanted pregnancies, and they are finding answers. The missing element is having a business case and proof of concept to show the people with money that their investment in trying to make these new products available to people safely, is going to pay off.

But would people actually take it? According to a YouGov poll one in three sexually active men would consider taking ‘a male version of the pill’ which suggests they would do so irrespective of side effects. In the same poll, 50 percent said they weren’t sure. Likely, this would be in order to weigh up the side effects. An article in the Independent recently looked into whether women could trust men to take it, and generally the men interviewed seemed keen, at least provided the side effects were minimal. A small poll I conducted on Twitter was even more optimistic, with only 12% of people saying they wouldn’t take it, and the rest divided between ‘yes’ and saying it would depend on side effects. Even with the biggest pinch of salt, it seems men also don’t want to accidentally get someone pregnant.

There are many other questions around a ‘male version of the pill’, such as the attitude towards condom use and whether a pill that men could take would make them less likely to wear a condom, which is important for stopping STIs. There’s also the question of responsibility with anyone who is taking contraception. If you don’t take it properly, it may not work. Globally, there are challenges too.In Bangladesh, a poll showed that people preferred the idea of contraceptive gel more than pills, bucking the trend for other places worldwide. Cultural sensitivities around how contraception is used, and who uses it, can also add to the burden of who takes the contraception. However, given that almost half of pregnancies worldwide are unwanted, the need for more forms of contraception to exist, and for them all to be better, is very real.

One day, a lab like Balbach’s might raise the funds to do clinical trials in humans for a new form of contraception such as the sAC-inhibiting on demand pill she is trying to create. The trials might prove that anyone can use that contraception with minimal side effects. When paired with a barrier, like a condom, it might have virtually no risk of pregnancy, of transferring STIs and STDs, and no side effects for anyone at all. Every pharmaceutical company is going to want to be the company making money off that product, and therefore it could well become something people have access to worldwide.

Ultimately, more choice is more choice. If people have more forms of contraception to choose from, the options can be negotiated more than before. The burden, where it is one, might be shared in a way that is better for everyone. It is progress. Hopefully one day, there will be so many products at fair price points, that are culturally sensitive, in every part of the world so that people of all genders will be able to choose, with full riskless autonomy, whichever method of contraception they want to use.

We aren’t there yet, but every new development, every new contraceptive brought to market that works and has less side effects and compromises than the previous is a step toward that end goal. There’s a lot of work to be done in the labs, but that’s the easy part. “We want to make the world a little bit better, which sounds cheesy, but it’s why I go to the lab every day.” Says Dr Balbach.