Why Don’t We Have a Male Birth Control Pill (or Gel) Yet?

Condoms suck. We can all agree on that. Lining two grams of latex between points of pleasure can irritate almost anyone, the exceptions being sadists, masochists and those with a fetish for eco-friendly plastic. It’s not like likely that you fit any of those profiles.

Instead, you might want to know why in 2019—almost 2020—CNN, Facebook, or whomever you mistakenly get your news from hasn’t yet told you, ‘Today is the day; go to CVS after work, or before your over-priced yoga class, and pick up the new hormonal birth control method for men.’

We’ve all seen reports that male birth control could “soon be a reality.” You may have come across speculation that the pill-for-men could be available by 2017…or 2021. In 2017, CNBC promised that doctors were “on the cusp” of bringing consumers the first male contraceptive. So what happened?

Every year, the subject of male birth control is repackaged—with whatever meagre research has progressed—and it’s re-sold to the masses as a paradigm-shifting, upcoming product that’s perpetually just around the corner.

Where is the male birth control pill we’ve been promised?

In 2017, The New York Times ran an op-ed written by Elaine Lissner, director for The Parsemus Foundation, which ensured that Vasalgel, a pill she had been promoting, was the male birth control “most likely to make it to the U.S. market in the near future.” Broadly ran their own report the same year, declaring “A Safe, Effective Birth Control Pill for Men May Soon Be on the Way.” Neither story mentioned the same drug and neither drug is available today.

In March, a group of researchers presented their preliminary findings on a male birth control pill at the Endocrine Society’s annual meeting. Called 11-beta-methyl-19-nortestosterone dodecyl carbonate, or 11-beta around the office, this pill was administered to 40 men in a 28-day clinical trial. According to the researchers, the drug was “well tolerated,” as it reduced the hormones needed for sperm production.

It seemed like the medical field finally had a promising result on male birth control. Maybe not ideal findings, but surely a sign of progress. And progress on a drug means imminent availability, right? Wrong again.

While no one expected 11-beta to land at drugstores within a week, it’s not projected to be released until 2025. But you shouldn’t be too surprised. This isn’t the first male contraceptive to capture public attention before being brought back into the lab for years of further testing. The path any drug takes from “promising preliminary findings” to point of purchase is long and winding—and male birth control is a particularly complicated example.

All the Types of Male Birth Control Currently Undergoing Testing

Though this new pill has generated a lot of press, there are many more undergoing testing. And even then, 11-beta is a variation of DMAU, another daily pill that’s actually further along in its own clinical testing. But there’s many more pills to take into account. There’s levonorgestrel, essentially Plan B mixed with testosterone injections, which has shown itself to be a pretty effective way of lowering sperm counts to virtually zero. There’s also Nestorone-Testosterone or NES/T, a testosterone and synthetic progestin topical gel that patients apply to their arms and shoulders. NES/T is furthest along in clinical trials with more than a decade of self funded-research behind it. In early 2019, the gel passed human safety tests with minimal side effects. 

And in India, researchers have nearly finished testing an injection-based contraceptive known as RISUG (reversible inhibition of sperm under guidance). However, RISUG and the other drugs mentioned above are not expected to hit the market anytime soon.

“We’re talking about 10 years from now for the product that’s the furthest along,” said Diana Blithe, chief researcher at the NIH’s National Institute of Child Health and Human Development. NES/T’s current trial will take about three years, and a larger Phase III trial will take even longer. If it passes all its trials, it has to seek an approval by the FDA, which in the best scenario could take anywhere from six months to two years.

Why The Search for Dependable Male Birth Control Is Taking So Long

Male contraceptives were first tested in the 1950s by Gregory Pincus, co-inventor of the first birth control pill for women. He hoped to create an analog of the female pill and began testing his hypothesis through highly controversial means— by injecting both male and female patients in Massachusetts mental hospitals and later in the Rio Piedras ghettos of San Juan, Puerto Rico. The results were inconclusive and testing was inconclusive. But it didn’t matter. In 1960, one year after the final Puerto Rico trials, the FDA approved the female birth control pill. Pincus and his associates packed their bags and moved on, leaving the trials otherwise lost to history. 

Testing picked up again in the 1970s, when a non-hormonal drug called gossypol started generating hype. It had passed clinical trials in China by 1972 and was showcased two years later at the UN’s 1974 World Population Conference. Elsimar Coutinho, then the lead researcher at the Federal University of Bahia, promoted the drug to a “conference hall full of women.”  In 2016, Coutinho told The New Republic, “I was going to tell [the crowd of women], ‘Now you don’t have to take pills if you don’t want.’ […]  To my surprise, I was shouted down and booed out.”

After a negative reception and later complications in future trials, research on Gossypol fizzled out. In the 1990s, the World Health Organization began sponsoring new multinational studies on male contraceptives. But few made it passed their first trial. Yet with these tests, the myth of a soon-to-arrive male birth control method began.

The subject of contraceptives is embedded in contentious debates over gender expectations. This occurred most famously in 2016, when a clinical trial for a male hormonal contraceptive injection conducted by the Guttmacher Institute went viral after it was canceled due to concerns about reported side effects of discomfort, weight flux, nausea, and feelings of depression — common side effects of female hormonal birth control.

“I’ve seen far too many articles that say ‘Scientists have created’ or ‘Male birth control is right around the corner,’ said Nickels. “The fact is, many of these efforts are in early, pre-clinical stages, and even once a drug gets to the clinical stage, as hormonal male contraceptives are, it can still be well over a decade before they pass the safety and efficacy bars needed to get to market.”

The public and initial news reports castigated study participants for not handling the discomfort women face every day. While the symptoms were found to be virtually identical to symptoms caused by female birth control, the side effects linked to the male pill were far more severe. To complicate things further, later reportage clarified that 75 percent of the study participants wanted to continue using the shot. 

“There’s always been this narrative in the field that male contraceptive methods won’t work because men wouldn’t accept a high level of side-effects,” said Megan Kavanaugh, a contraceptives researcher at the Guttmacher Institute, in an interview with The Daily Beast. “Maybe things are shifting and changing. Maybe it’s reflective of the broader societal move toward more gender equality.”

The real reason this study—which otherwise reported a 96% success rate—was cut is similar to the reason we don’t have high speed rails in major cities, renewable power grids in coal country, or Kris Jenner on Mars One. Everything comes down to securing investors. In the case of the 2016 study, it was one of the two independent committees, not the participants, that pushed to shut the whole thing down. This was reiterated in the study’s conclusion, published in The Journal of Clinical Endocrinology & Metabolism.

“This decision [to terminate the trial] was based on [the Research Project Review Panel’s] review of study [adverse events] and conclusion that the risks to the study participants outweighed the potential benefits to the study participants and to the increased precision of the study.”

The Journal of Clinical Endocrinology & Metabolism

The study’s cancellation, while not caused by the male participants, still sheds light on a troubling aspect about our culture’s expectations; in a society where women begin taking hormonal birth control often before they are even sexually active as an assumed rite of passage, investors often flake on products for men at the first sign of trouble.

“My impression is less that it’s about any sort of organized effort against male contraception, and more of an honest prioritization of addressing women’s needs first,” said Heather Vahdat, the executive director of MCI, in an interview with VICE. “That’s where most of the disparity comes from: lack of resources.” 

Yet, women’s needs didn’t come first, at least not for investors; it was the civil rights activist and future Planned Parenthood founder Margaret Sanger and fellow activist and financier Katherine McCormick who funded and advocated for research into female contraceptives in the 1950s.

And even then, as Snopes reports, when the pill was first developed, the FDA’s standards were far less stringent than today, and the drug was approved under now-unimaginable conditions. Today, the pill is embraced like racist grandparents, with its many flaws and potential side effects, such as the link between birth control and depression in young women.

“When the female pill was introduced, the doses of hormones were higher than they are now and the side effects were much greater,” Stephanie Page, a professor of medicine at the University of Washington and a senior investigator on DMAU, told Vox earlier this year. “So the bar is higher in terms of where we need to be to get something into the market. […] The goal is to develop something for men that is essentially side effect-free.”

Who is financially backing male birth control research?

Getting a birth control method for men to market will require overcoming side effects in the drug development process, winning over the pharmaceutical industry, and satisfying FDA safety standards, all while combating any cultural expectations of pregnancy prevention. Money can pose a serious problem, as the cost to test a drug is steep, costing on average hundreds of millions of dollars or sometimes billions, and even a fully funded method is no guarantee — it can still fail FDA approval. In fact, about 86% of drugs don’t pass the FDA’s second of three testing phases.

But there is hope. Since the conversation for male contraceptives has picked up, several nonprofits have stepped in to cover the associated costs. In 2017, the Male Contraceptive Initiative, a nonprofit that provides funding and advocacy for male contraceptives, funded a study to see how men felt about possible options outside of condoms and abstinence. In the United States alone, 45 percent of pregnancies are unplanned, and the attempts to drive this statistic down are arguably sexist—and inarguably ineffective.

“Unplanned pregnancies present significant immediate and long term effects related to health, poverty, and education, among other critical global issues. With an actual use pregnancy rate of 13.3 percent, it is clear that not only is there a need for more methods, but more effective methods of reversible contraception for men,” said an MCI press release. 

Since 2017, MCI has dispersed $1.7 million in funds from private donors toward global male contraceptive research, but not solely for hormonal birth control; the nonprofit also funds early research into methods that “prevent sperm-egg interaction,” as well as non-hormonal gels that block sperm from passing through the vas deferens. Though these forms of research may not be as far along in their testing, MCI is certain, since these forms won’t have the classic side effects of hormonal birth control, they’ll become a popular alternative.

“Condoms have a real-world failure rate of 15%, and some men just simply don’t enjoy them, said Logan Nickels, MCI’s Director of Operations and Programs. “Vasectomies can be reversed, but it’s expensive, requires microsurgery, and doesn’t always work. Men are basically left with an option that is marginally effective and one that’s equivalent to sterilization, which leaves a huge gap in their ability to participate in family planning.”

This seems to be an accurate call. Companies with male contraceptives in development still seem unsure where to focus their efforts, and no one has made a definitive call on when to interrupt the release of sperm. 

Why is birth control research so complicated?

According to Time, after Bayer purchased several labs researching male contraceptives in 2006, the medical giant ordered that its new labs abandon their research programs, with no plans to pursue any future studies, so as “to ensure that the business was investing resources in therapeutic areas that would bring the greatest benefits to patients while ensuring the company was operating in a financially responsible manner,” said Courtney Mallon, deputy director of U.S. Pharmaceuticals Product Communications for Bayer, in an email to TIME.

In 2015, a Bayer spokesperson told The Atlanticthat a male contraceptive wouldn’t be “as convenient as a woman taking a pill once a day.” Two years later, Bloomberg reported that male contraception wasn’t an “active area of research” for other major pharmaceutical companies, including Pfizer Inc. and Merck & Co., either. 

“The fact that the big companies are run by white, middle-aged males who have the same feeling—that they would never do it—plays a major role,” said Herjan Coelingh Bennink in an interview with Bloomberg. Bennink, a former gynecology professor, helped develop the female contraceptives Implanon and Cerazette for Organon pharmaceuticals between 1987 and 2000. “If those companies were run by women, it would be totally different.”

While big pharmaceutical companies claim it’s objectively more difficult to create a male contraceptive, the science shows otherwise. What is instead apparent is an unraveling of institutional misogyny— leaving everyone involved to suffer the consequences of inadequate options. 

Yet if condoms, a unanimously hated invention, can generate annual sales of $3.2 billion, how could male birth control not do any better?  And that doesn’t even include the current $10 billion female contraceptives market. In a way, male contraceptives are the smartest investment no one—including Bayer AG, Pfizer Inc. and Merck & Co.-—seems to want. 

“Drug development is expensive,” said Nickels. “Often an effort measured in billions of dollars. On top of that, lots of new drugs fail well before they get to your shelf. Most investors and drug companies aren’t willing to put that kind of money on the line for something that won’t see dividends for decades, and has a high chance of failure. We’re trying to incentivize the market by showing what types of products men are interested in, and driving the science forward to shape the products of the future.”

With use rates of the mutually-maligned condom in a steady decline and nonsurgical (today an estimated 175,000 to 550,000 surgical vasectomies are performed every year in the U.S) vasectomies on the express bus to mass appeal, it’s apparent that men are desperate for alternative forms of contraception. Yet for now, we may have to settle with the annual surge in  optimistic speculation.

“I’ve seen far too many articles that say ‘Scientists have created’ or ‘Male birth control is right around the corner,’ said Nickels. “The fact is, many of these efforts are in early, pre-clinical stages, and even once a drug gets to the clinical stage, as hormonal male contraceptives are, it can still be well over a decade before they pass the safety and efficacy bars needed to get to market.” 

“Don’t get me wrong – the field is more exciting than it’s ever been, and we’ve seen projects pop up, companies being started, and more, but drug development takes a long time, and we need to make sure the public is aware of the challenges of getting a product like this to market.”

And even then, not all pills are meant for the shelves. Just like the infamous 2016 study and the recent reception for 11-beta, some tests are instead meant to advance the field of male contraceptives as a whole. “The goal is to find the compound that has the fewest side effects and is the most effective,” Page told Bloomberg. “We are developing two oral drugs in parallel in an attempt to move the [contraceptive medicine] field forward.”

In the meantime, women today carry all responsibility in preventing pregnancy, with over a dozen options offered, from long term options like IUDs to short-term options like vaginal rings and diaphragms. Women even have their own condoms. There are ways in which the men of the world can at least pick up some of the slack. 

“[Women] may or may not request your help, said June Gupta, NP, Associate Director of Medical Standards at Planned Parenthood. “If they do, one way to support them includes helping them learn about and choose their contraceptive method based on their needs and what’s most comfortable for them. Depending on which method your partner ultimately chooses, you should educate yourself on the potential side effects your partner may experience — including changes to their periods.”

Ask your partner how you can help out—women bear the brunt of pregnancy prevention, and it’s a costly and under-appreciated burden. Offer to help pay for their contraceptives, help schedule their appointments, ask if they want reminders to take their pill, or at least be a shoulder to lean on every once and awhile. 

“To show that you are both thinking proactively about preventing an unintended pregnancy, show that you appreciate their effort to prevent an unintended pregnancy,” said Gupta.

One day, male contraception will be realized. And if you’re lucky and helpful, she may buy you the first round.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s