NO NEED FOR SEED

Seriously, though: Why hasn’t male birth control happened yet?

Elena Scotti/FUSION

The problem with male birth control is that it’s always coming soon.

For more than a decade, optimistic headlines have promised that new forms of contraception for men—besides condoms or vasectomies—were “in [the] works” or getting “closer” or “almost here.” But they’ve never quite gotten here.

By now, the pattern is familiar: A male birth control article goes viral, we all get excited, and then we forget about it within a few days only to get fired up again when the next study comes out. The internet has a frustratingly short memory. But for those of us reporting on male contraception, it’s getting harder to feign amnesia. As a sarcastic Rewire headline recently put it: “Male Birth Control Pill Is Still ‘Right Around the Corner,’ Like It Has Been for Years.”

The more time goes on, the more potential male birth control options pile up. In the 2000s, we heard about progestin injections and testosterone implants that could stop sperm production. We read reports about protein-blocking compounds that could render sperm physically incapable of fertilizing an egg. All of that research is ongoing, but contraceptive drugs that suppress or impair sperm are still years away from being ready for humans.

In the last few years, our attention has shifted to non-hormonal options like Vasalgel and Echo-V, polymer gels that are injected into the vas deferens where they can physically block sperm from reaching the urethra. But neither gel has entered U.S. clinical trials. In 2014, the nonprofit behind Vasalgel was hoping to get to market by 2017 at the earliest; now, they’re aiming for early 2018. Echo-V manufacturer Contraline is eyeing 2020.

So despite all the hub-bub around birth control for men, it seems likely that we’ll enter the third decade of the 21st century without any reliable, reversible, long-acting forms of male contraception on the market.

Meanwhile, women have a list of birth control options as long as a New Jersey diner menu that includes implants, injections, patches, sponges, intrauterine devices (IUDs), cervical caps, and, of course, “the pill.” But ordering off that menu can be a challenge—and if President-elect Trump repeals or alters the Affordable Care Act, some women could face more hurdles in the years to come. Already, thanks to the potential side effects of hormonal contraception, women have to weigh the risks of unintended pregnancy against a wide range of possible mental and physical ailments including but not limited to weight gain, mood changes, decreased libido, nausea, and acne.

“Right now, there’s no major pharma company putting any kind of investment into male contraceptive drug development.”

- Aaron Hamlin, executive director of the Male Contraception Initiative


There’s strong evidence that men are willing to shoulder some of these same side effects to get more involved in contraception. A few weeks ago, an injectable hormonal male birth control study made the media rounds, with headlines suggesting that some of the men who withdrew from it “couldn’t handle” the side effects that women experience. But as Julia Belluz observed at Vox, the untold story was that more than 80% of men said they would still use the drug, side effects and all—in part because their partners were “relieved that they did not have to bear the burden of contraception themselves.”

But will men ever be allowed to take on more responsibility for contraception? I asked some of the leading experts on male contraception why reversible, long-acting birth control for men hasn’t happened yet and when it will finally arrive. While their estimates varied, they all agreed that the main obstacle is money—or, more specifically, the lack thereof. If drug development were less expensive and the logic behind contraceptive approval less sexist, there’s a chance we could have had a blockbuster male contraceptive drug already.

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Major pharmaceutical companies were once interested in male birth control. Most notably, German drugmaker Schering and Dutch pharmaceutical company Organon jointly explored an injectable hormonal male contraceptive in the 2000s. But Schering grew concerned that requiring multiple injections would discourage men from using the method. Doubts about the market combined with high development costs sent pharma firms running away from male birth control in a hurry during the mid-2000s, as Time reported. Schering withdrew in 2006 and the rest of the major pharmaceutical funding for male contraception dried up shortly thereafter.

“Right now, there’s no major pharma company putting any kind of investment into male contraceptive drug development,” Aaron Hamlin, the executive director of the Male Contraception Initiative, told me.

Instead, MCI has been working to connect researchers with funding sources like grants from the National Institute of Child Health and Human Development. Some nonprofit organizations—like the Parsemus Foundation, which is funding Vasalgel—are also putting dollars toward research and development. But pharmaceutical power players are still unwilling to commit to male birth control after their earlier forays into the field.

161128-male-bc-4Elena Scotti/FUSION

Indeed, even female contraceptive development is more stagnant than it should be. As the Guttmacher Institute noted in a 2013 report, “large pharmaceutical and biotechnology companies, for the most part, have abandoned the field of contraceptive research and development.” As a whole, the report continued, the industry has been more focused on “adaptations of existing technologies” rather than “true technological breakthroughs.”

You might think that Big Pharma would be financially motivated to make a breakthrough in the male birth control space. The opposite is true: Given the current costs of drug development, it makes more sense not to invest in long-acting male contraception—at least in its current state. Most of the male birth control drugs and devices that you’ve heard so much about online are caught in an early stage of development between academic studies and clinical trials known as the “Valley of Death.” During this phase, risks are high and expenses are large. Major pharmaceutical companies would much rather invest in drugs that have crossed the Valley intact.

As John Howl, a University of Wolversham pharmacologist whose recent sperm-impairing male birth control study attracted media attention, told me, “I suspect many of the studies, including our own at present, may be at a stage that is just too preliminary for pharmaceutical interest.”

And because female contraception is already a multibillion-dollar market, pharmaceutical companies may see the pursuit of male birth control as self-defeating. The Parsemus Foundation argues that major pharmaceutical companies would “cannibalize existing sales” if they started selling contraceptives to men. Or, as Contraline CEO Kevin Eisenfrats told me, “They don’t really want to sponsor the research that is going to disrupt their current standing in the industry.”

There’s another, more technical challenge facing male birth control. According to Hamlin, part of the issue is that, in the 2000s, the pharmaceutical industry chose to invest in a complicated—and therefore expensive—form of male contraception first: hormonal birth control.

“With women, there’s a natural physiological state when they don’t ovulate—it’s when the body is pregnant—so [with hormonal birth control] you just fool the body into thinking it’s pregnant and you don’t ovulate,” Hamlin explained. But since men are fertile all month, “it takes quite a bit to get men to stop producing sperm.”

“To be honest, men had less incentive to tolerate those side effects—they weren’t the ones getting pregnant.”

- Jonathan Eig, author of The Birth of the Pill

Men are indeed sperm fountains, releasing tens of millions of gametes every time they ejaculate. Cutting off that supply with hormones is challenging. And as women well know, tinkering with someone’s hormone levels can cause side effects that make investors skittish.

“There are a lot of practical issues for that route and I think the pharma industry has seen that and been turned off by it,” Hamlin said, adding that the industry should have examined non-hormonal approaches instead of abandoning male birth control altogether.

Some CEOs, like Eisenfrats, are turning to Silicon Valley’s angel investors to fund male birth control. “The interest is definitely there,” he said. “And the opportunity is tremendous.”

The global contraceptive market will exceed $30 billion in the 2020s. But whoever wants to bring men into that market quickly will have to find a source of funds as limitless as semen itself. And if Big Pharma isn’t biting, the money will have to come from somewhere else.

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The original angel investor of contraception was Katharine McCormick, a wealthy biologist who helped make “the pill” possible in the 1950s and 60s. McCormick could have spent her millions on male contraceptive research instead, but she didn’t.

“From a historical standpoint, the feeling was that men couldn’t be trusted with [contraception],” Jonathan Eig, author of The Birth of the Pill, told me. “The women who sponsored the early research felt like it had to be a tool for women because they didn’t believe men were willing, able, or trustworthy enough to have that power. If women were going to control their own bodies, they needed to [have] the tool that allowed them fertility control.”

Along with Planned Parenthood founder and birth control pioneer Margaret Sanger, McCormick provided the funds for biologist Gregory Pincus and gynecologist John Rock to develop a long-acting contraceptive in the 1950s. Early on in the research process, as Eig detailed in his book, Pincus experimented on both men and women, administering progesterone to 16 people of each gender in a Massachusetts mental asylum. But the women in the asylum weren’t having sex and the men started refusing to give semen samples, so it became impossible for Pincus to gather solid data. And Sanger and McCormick “made it clear that they weren’t interested in a birth control pill for men,” anyway. They wanted the contraceptive revolution to come to women first.

Their money talked. Pincus stopped experimenting on men, the research into female contraception moved forward, and, after the FDA approved “the pill” in 1960, it didn’t take long for women to assume primary control over long-acting contraception—as they still do today.

“There are lots of men out there who care deeply about their partners and they don’t want them to suffer the side effects.”

- Aaron Hamlin



But even if Sanger and McCormick had funded research into male contraception in the 1950s, we might still be waiting for it to materialize. Pincus’s early experiments in the asylum gave one man “shrunken testicles” and nurses said they made another man more “feminine,” as Eig detailed in The Birth of the Pill. The researchers observed side effects among women as well but they didn’t exactly lose sleep over the thought of female suffering.

“These scientists were all men and they were fairly cavalier about side effects for women but I think they recognized that men would never tolerate such serious side effects,” Eig told me. “And to be honest, men had less incentive to tolerate those side effects—they weren’t the ones getting pregnant.”

Now that we’re out of the Mad Men era, however, many men would be happy to put up with some side effects, as that latest injectable male birth control study proved, despite the misleading headlines. But male approval and FDA drug approval are two entirely different beasts. And because pregnancy requires a uterus, the FDA would likely be unwilling to let a male contraceptive hit the market with side effects equivalent to the ones that women face.

“You’re dealing with an otherwise healthy population and so the tolerance for side effects is very low,” Hamlin explained. “It’s not saying that men wouldn’t put up with much, it’s saying that the FDA would not tolerate very much because you’re offering a drug to an otherwise healthy population.”

And it’s not that women are “unhealthy,” per se, Hamlin clarified, but that the FDA is willing to let women choose between the risks of hormonal contraception and the risks of unintended pregnancy because they have to face the latter firsthand. That logic is sexist and paternalistic, but it’s not necessarily how individual men view the situation—it’s the harsh reality of the contraceptive drug approval process. In a sexist society that thinks of unplanned pregnancy as a woman’s problem first and foremost, male birth control won’t happen unless it’s virtually side-effect free.

That presents male birth control backers with a high hurdle to clear: You could spend millions on research and development only to discover disqualifying side effects in large clinical trials. Until deep-pocketed people are willing to take that bet, new methods of male birth control will never arrive.

What we need, Hamlin believes, are modern-day Katharine McCormicks.

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Despite all of the risks, investors do have one major incentive to get involved in male birth control: The market for the product is huge and untapped.

More than half of male respondents to a large-scale international study in Human Reproduction said they would be willing to use hormonal contraception. So just imagine, Hamlin said, “if you gave them a nonhormonal option, how many more would jump in.” Another benefit of non-hormonal options like Vasalgel or Echo-V is that they would only have to be approved as medical devices, not drugs, which means they could potentially get to market sooner.

And even a small percentage of men who have gone through puberty would amount to a large pool of potential consumers. As a 2012 study on male birth control demand noted, “Even assuming that only 25% of men who indicated they would ‘definitely’ or ‘probably’ use male contraception in the [Human Reproduction] survey, the estimated number of potential users aged 15-64 years in those nine countries alone is close to 44 million.”

Millions of men would take long-acting birth control, Hamlin and Eisenfrats argue, for a variety of reasons: to have more control over their own fertility, to avoid paying thousands of dollars in child support, or to ensure that their romantic relationships can develop without the pressure of an unintended pregnancy. But many men who reach out to their organizations have a more altruistic motive in mind.

There are lots of men out there who care deeply about their partners and they don’t want them to suffer the side effects—particularly when it’s not necessary and they could go with their own option,” Hamlin told me.

When will men finally have that revolutionary new contraceptive? Howl said it could happen “within ten years.” Eisenfrats wants to get Echo-V into human trials within two.

Without major funding—whether it comes from nonprofit fundraising or Silicon Valley—male birth control will be a carrot that is always just out of reach. But we aren’t powerless in this process. Hamlin, Eisenfrats, and others working in this space still have to persuade investors that men do want to play a larger role in contraception. The more vocal men are about their desire for a viable alternative to condoms, the easier a sell that will be.

And if we want men to be more vocal, our gendered attitudes toward pregnancy will have to change. The sexist idea that women should take primary responsibility for preventing pregnancy is, as Eig put it, “embedded in our culture” by now. “It’s going to be difficult to overcome that,” he told me, “even with a terrific new product.”