The Real Story of Male Birth Control

A cartoon interpretation: a birth contorl package with a pink background with a few clouds scattered throughout the image. Image from Pussypedia Image from Pussypedia

The following text uses the word “pussy” as defined by Pussypedia.

by Claire Mullen

 

From its beginnings the birth control pill was framed as a form of liberation: a way for people with pussies* to control their cycles, claim reproductive autonomy, and separate the act of having sex from the outcome of having children.1

But with side effects like breast cancer and depression, hormonal birth control can feel more like a burden than a blessing.2

Since the birth control pill was first approved in 1960 as a contraceptive in the US, people with female reproductive systems have carried this burden in the majority of relationships that can produce pregnancies. According to the the Centers for Disease Control and Prevention (CDC),3 62% of (cisgender) women between age 15-44 in the US use contraception (26% of those use birth control pills), while only 33% of (cisgender) men use contraceptives (they counted those who use the “pullout method” in this statistic). The US Food and Drug Administration (FDA) has approved 17 birth control methods for people with pussies* and only two for people with sperm (condom and vasectomy).4

The pullout method (taking a weener out before the semen comes out) is known to be unreliable (failure rate when used alone is around 20%), and while in practice condoms have a pregnancy-preventing failure rate of about 13%.5 Vasectomies (a surgery on the semen system) are the most reliable, with a failure rate of less than 1%, but they are not easily reversible and therefore not a viable option for people who might want to have biological children in the future.6

According to the research firm Global Market Insights, if a new male contraceptive method is approved in the next five years, it projects the market would grow to $1 billion by 2024, and by an annual rate of 6% for the following decade.7  And still—there have been some attempts—but no new contraceptives for sperm-producing people have become publicly available within the last century.8

Why is there still no male birth control?

In 2002 two European drug companies, Schering and Organon, joined forces and developed a hormonal pill for sperm-producing people that seemed to work.7  The study was halted in 2006 after Schering was bought by the pharmaceutical company Bayer AG9, who decided the project was not “financially responsible” and has no plans to pick it back up.7

Bayer is one of the top sellers of hormonal birth control products, a market that produces internationally around $18.4 billion dollars per year.10 Bayer owns the Yaz pill and three of the four hormonal IUDs available in the US; Mirena, Skyla, and Kyleena.11 It is possible, therefore, that in addition to all of these other hurdles, developing a new birth control method for people with sperm could eat into the profits that companies like Bayer make from birth control pills and IUDs for people with pussies*. This would be particularly troubling if a product came out that were long-term and reversible, which would likely cause pills sales for people with pussies* to decrease. Some companies, like Pfizer, also sell condoms, a market which is worth $3.2 billion a year, and has a much higher profit margin (condoms cost only a few cents to make but sell for $1.12 on average in the US, with some as high as $4 each).12  But other markets aside, Bayer would have had plenty of reasons not to continue.

Scientists estimate it would take about $100 million and 10 years to make a birth control product publicly available for people with sperm.

A pill for sperm-producing people would be expensive for drug companies to produce, and doesn’t seem like a safe investment.

Scientists estimate it would take about $100 million and 10 years to make a birth control product publicly available for people with sperm.9 For people to be able to purchase a product in any country it must be approved by that country’s governmental health organization; in the US drugs are approved by the FDA, in Europe by the European Medicines Agency (EMA), and in Mexico by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Each organization has its own guidelines, but all require many expensive phases of testing on both animals and humans before a drug can be sold to the public.13  Because of the price of entry, big pharma companies rarely invest in drugs they can’t guarantee will end up being profitable. And it would be hard to make a profitable (cisgender) male birth control for a few reasons.

One reason it would be expensive to make is that birth control must also be effective as close to 100% of the time as possible. Even if they did achieve that, the drug would be doomed to a low profit margin because of the low prices of birth control for people with pussies*. The patents on most brands of hormonal birth control for people with pussies* have already run out, so drug companies have to lower their prices to compete with generic brands. Birth control has become pretty cheap for us and has a low profit margin for drug companies when compared with other drugs.9 This affects the chance for any potential new male birth controls to have a high profit margin because it would have to have a cheaper or similar price since people probably won’t switch to a new method if the option for their partner is cheaper.

And even if they could make it profitable, they think people with sperm won’t buy it because it’s “emasculating.”

Another reason that many researchers say pharmaceutical companies don’t invest in male contraception is that they worry that even given the option, people with sperm won’t want to use it.8  This may come from the stigma around anything “emasculating,” and the idea that many men will likely not want to engage in procedures that involve surgeries or injections in their genitals. Additionally, people with sperm may not feel as incentivized to take on the responsibility of contraception because it is not their body at risk of becoming pregnant.

“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,” Herjan Coelingh Bennink, a gynecology professor and previous head of research and development for Organon International, said in response to why a new option does not already exist.9 “If those companies were run by women, it would be totally different.”

It’s possible that as culture changes more young sperm-producers will want contraception. “I think as research continues, more men will be open to it—particularly men broadly interested in social justice, or personally interested in helping a female partner,” said Daniel Dudley, a 28 year old man who has participated in multiple studies on birth control methods in a recent interview with Time Magazine; “Our society is moving towards more gender equality in many areas. This is an obvious next step.”7

Dr. Stephanie Page, author of one of the studies Dudley participated in, remarked, “We have a lot of positive momentum right now. I think the field may be in a different place because the public is expressing quite a bit of interest. There are changes happening socially. It seems different from 15 years ago.”7

The side effects are harder to justify without pregnancy as a potential outcome.

Birth control is unique because people will likely take it over the course of many years to decades, and it is taken by healthy people to prevent an outcome rather than cure a problem.14 Because birth control methods are used for so long and can cause side effects that are difficult to predict, pharmaceutical companies that sell these drugs are also exposed to higher risks of lawsuits.11 One example is the recent $100 million lawsuit against the makers of NuvaRing due to blood clots, heart attacks, strokes, and death.15

In the 60’s, supporters of birth control pills had to argue to the FDA that a drug made for people who were healthy was actually beneficial for them, because complications from birth are often riskier than the pill’s side effects.14 It’s harder for drug companies to argue for the approval of a drug where a healthy person risks possible side effects in order to prevent a harmful medical outcome in someone else, i.e. a sexual partner.7 And even after approval—people probably won’t switch to a new method if the option for a partner is less risky—especially if they can’t get pregnant anyway.

“Pregnancy is in itself a health risk for women,” said Dr. Arthi Thirumalai, a researcher on male birth control studies at the University of Washington. “So you could argue that women are trading one risk for another, and men are not.”11

In 2016 the results of a Phase II medical study done in multiple countries on birth control injections for people with sperm were made public.16 According to the study, the method had a 96% success rate for the 320 participants. But some men complained of mild to moderate mood disorders, acne, injection site pain, and increased libido.17 Their complaints were depression and changes in mood.

Magazines ran articles lambasting the participants’ inability to stick with the trial, like one in Cosmopolitan, titled: “Men Quit Male Birth Control Study Because It Was Giving Them Mood Swings. Welcome to the club, dudes. Also: WOMAN UP.”18 The title points to the double standard of birth control in relationships that can result in pregnancy – cisgender men spared from side effects while people with pussies* are expected to deal with them.

But to be fair to the “dudes,” their trial was shut down by an independent board organized in part by the World Health Organization—not because they quit. In fact, over 75% of participants and their partners said that they would use a similar method of contraception if it became publicly available.17 Still, the independent board stopped the trials because “the risks to the study participants outweighed the potential benefits to the study participants.”17

Meanwhile: Possibilities for the Future

Challenges facing drug companies that wish to develop forms of birth control for sperm-producing people are many. New drugs undergo expensive testing phases (much more rigorous than when drugs for people with pussies* were approved in the 1960’s!) and they have to have lesser side effects to be considered acceptable for a healthy person to use.  Pharmaceutical companies don’t have an incentive to risk lawsuits or pay for expensive trials if they can’t charge a higher price in the end, and they’re not sure anyone will buy these new products, even though public perception of contraception is changing. These are major challenges to overcome, but some researchers are still pushing ahead with devices and drugs that could be the birth control methods of the future.

In a 2017 paper titled Male Contraceptives: Present and Future Approaches, the authors Daulat RP Tulsiani and Aida Abou-Haila lay out the possible ways birth control could work for people with sperm:

  1. Stopping the testes from making sperm or lowering the number that they make
  2. Stopping the sperm from maturing into their final form
  3. Stopping the sperm from getting to the eggs
  4. Stopping an important chemical change for the sperms that happens in the “female” reproductive tract
  5. Stopping the sperms from fertilizing the egg.

All of the options currently in use are based on the fifth step—preventing sperm and egg interaction—either with device-free approaches (abstinence and “pullout”), or barriers (condoms and vasectomy).8 But other possible methods are in the works.

1. The balls switch:  

The Bimek SLV is a switch that is inserted underneath the skin of the scrotum. The company claims that when inserted it is turned “off” to prevent the flow of sperm. They state that the sperm-producing person can still be fertile for 3-6 months, however, until all sperm is cleared from the duct. If the person later wanted to become fertile all they would have to do is switch the device to “on” by pushing on the switch underneath their skin. They would immediately return to being fertile as the reproductive system does not stop producing sperm. According to their website they cannot move ahead with trials until more funding is secured, so research is at a standstill.19

2. “Indonesian male” pill:

A non-hormonal pill called the “Gandarusa Pill” or “Indonesian male pill;” has been approved by the equivalent of the FDA in Indonesia, but testing has not begun in the US. Tulsani and Abou-Haila’s report:

Tribesmen on a remote island of Papua, Indonesia, have long known that if they chewed leaves of the plant “Gandarusa” (Justicia gendararussa) 30-40 minutes before coitus, their wives did not get pregnant. Researchers in Indonesia began analyzing Gandarusa leaves in 1988, and began animal and human trials in the 1990’s. The biologically active compound from the plant was identified and patented in 2007. There are no published reports on the compound or how it functions. However, according to government reports, the purified agent, when used by men in the form of a pill, prevents pregnancy by inhibiting the activity of multiple enzymes that prevent sperm from penetrating the egg’s extracellular coat to fertilize it.

In tests, sperm regain fertility within 72 hours. This points to a natural, non-hormonal and reversible option that, if funded and tested, could become available outside of Indonesia in the next decade.8

3. The sperm strainer:

RISUG is a reversible, non-hormonal option that basically works by forming a sperm strainer. A non-toxic gel (maleic anhydride dissolved in dimethyl sulfoxide) is injected into the lumen of the vas tubes. It coats the walls of the tubes within minutes and stays in place due to its high molecular weight. The chemicals form a gel that blocks sperm but allows fluid to pass through, preventing the buildup that can sometimes occur with traditional vasectomies. The method takes about 15 minutes to complete (watch an animated video explainer here). It is reversible with another injection that dissolves the gel, allowing it to exit the body. RISUG is being developed in India by Sujoy Guha, a biomedical engineer. Guha has been testing RISUG with couples in India for nearly two decades, and has seen its success in preventing pregnancy for as long as 13 years, in some of his long term trials.9

RISUG became part of a US national debate in 2017 when Bloomberg, among others, published articles claiming India could see this technology come to market as soon as 2019.9 Guha has been working on this product for decades though, and so far has seen very little interest from international pharmaceutical companies. “In doing anything abroad, quite substantial money is required, and that can only come from the pharmaceutical industry,” Guha said in an interview with Bloomberg.

Instead, Guha is partnering with a US-based non-profit, the Parsemus Foundation, to work on international distribution. The Parsemus version, with a slight chemical difference from RISUG, is called Vasalgel. It is planned to be distributed at cost at around $10-$20 per person in low- and middle-income markets, and as much as $400-$600 in higher income markets to cover research and development costs. According to the Parsemus Foundation and Bloomberg, the Vasalgel project is currently seeking funding for human trials after successful trials in rhesus monkeys.20

4. Nestorone-Testosterone hormone gel

This is a hormonal gel that is applied externally daily to the back and shoulders. The gel contains an artificial version of the female hormone progesterone (which people with sperm have in low levels too) which lowers the amount of testosterone produced in the testes to reduce sperm production. The gel also contains some testosterone though, because sperm production requires much more testosterone than other bodily functions, and with low levels of testosterone in the blood people with sperm are more likely to experience side effects like low libido and problems with ejaculation.21

In initial 24-week tests the gel was effective in lowering sperm in 88% of the men.21 It’s now moving on to Phase II testing this summer with 420 participants in multiple countries.22 If it continues to appear safe and effective it will move into a third round of testing.23 Even though it is one of the methods closest to FDA approval, it will still be years before it comes to market, if all goes well.

So, when will we see a new method of birth control for people with sperm?

Most scientists and pharma experts say maybe in the next decade. In the meantime people with pussies* will continue to bear the burden of the majority of contraceptive planning in sexual relationships that can result in pregnancy.

Author’s Dedication: To Mwende Hinojosa for that one time she raised this topic in a room full of men. Their skepticism motivated me to learn this history, and to gather together some options they might be less skeptical of in the future.

Sources

  1. Planned Parenthood. “The Birth Control Pill: A History.” Last updated June, 2015. <https://www.plannedparenthood.org/files/1514/3518/7100/Pill_History_FactSheet.pdf>.
  2. Peachman, RR. “Weighing the Risks and Benefits of Hormonal Contraception”. JAMA. 319(11). (2012): 1083-1084. <https://www.ncbi.nlm.nih.gov/pubmed/?term=29490363>.
  3. Jo Jones, William Mosher, Kimberly Daniels. “Current Contraceptive Use in the United States, 2006-2010, and Changes in Patterns of Use Since 1995.” National Health Statistics Reports. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. 60. (2012): 1. <https://www.cdc.gov/nchs/data/nhsr/nhsr060.pdf>.
  4. Food and Drug Administration. “Birth Control Chart.” FDA, USA. Last updated February 16, 2018. <https://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm522453.htm>.
  5. Sundaram A, Vaughan B, Kost K, Bankole A, Finer L, et al. “Contraceptive Failure in the United States: Estimates from the 2006-2010 National Survey of Family Growth.” Perspectives on Sex and Reproductive Health. 49(1). (2017): 7-16. <https://www.ncbi.nlm.nih.gov/pubmed/28245088>.
  6. Rayala BZ, Viera AJ. “Common Questions about Vasectomy” American Family Physician. 88(11). (2013): 757-61. <https://www.researchgate.net/publication/259454272_Common_Questions_About_Vasectomy>.
  7. Sifferlin, Alexandra. “Are We Finally Ready for the Male Pill?” Time Magazine. (2018): <http://time.com/longform/male-pill/>.
  8. Daulat RP Tulsiani, Aïda Abou-Haila. “Male Contraceptives: Present and Future Approaches.” Clinical Research: Gynecology and Obstetrics. 1(1). (2017): 1-12. <https://pdfs.semanticscholar.org/0496/b43a8639cfac62eacf82c189342479b0fdc1.pdf>.
  9. Altstedter, Ari. “A New Kind of Male Birth Control Is Coming.” Bloomberg News. (2017): <https://www.bloomberg.com/news/features/2017-03-29/a-new-kind-of-male-birth-control-is-coming>.
  10. Grand View Research. “Hormonal Contraceptive Market Size, Share & Trends Analysis Report By Method (Pill, Intrauterine Device (IUD), Patch, Implant, Vaginal Ring, Injectable), By Region, Vendor Landscape, And Segment Forecasts, 2018 – 2025.” Market Research Report 2016. (2018): <https://www.grandviewresearch.com/industry-analysis/hormonal-contraceptive-market>.
  11. Ellis, Sarah. “Biology, Funding, and Ego Slow Quest for Male Birth Control. Rewire News. August 8, 2018 <https://rewire.news/article/2018/08/08/slow-quest-for-male-birth-control/>.
  12. Palmer, Brian. “The Great Condom Heist.” Slate Magazine. February 9, 2011. <http://www.slate.com/articles/news_and_politics/explainer/2011/02/the_great_condom_heist.html>.
  13. Canadian Cancer Society. “Phases of Clinical Trials.” Retrieved June 16, 2018. <http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/clinical-trials/phases-of-clinical-trials/?region=on>.
  14. Junod, Suzanne White, Ph.D and Lara Marks. “Women’s Trials: The Approval of the First Oral Contraceptive Pill in the United States and Great Britain.” Oxford University Press. Vol 27. 2002. <https://pdfs.semanticscholar.org/d697/3ca8c505c423ba914b050025082be8fe4516.pdf>.
  15. Tuner, Terry. “NuvaRing Lawsuits.” DrugWatch. Accessed 2018. <https://www.drugwatch.com/nuvaring/lawsuits/>.
  16. Mullin, Emily. “Why We Still Don’t Have Birth Control Drugs for Men.” MIT Technology Review, November 11, 2016. <https://www.technologyreview.com/s/602797/why-we-still-dont-have-birth-control-drugs-for-men/>.
  17. Behre, Hermann M et al. “Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men”. The Journal of Clinical Endocrinology and Metabolism. 101(12). (2016). <https://academic.oup.com/jcem/article/101/12/4779/2765061>.
  18. Beck, Laura. “Men Quit Male Birth Control Study Because It Was Giving Them Mood Swings.” Cosmopolitan. October, 2016. <https://www.cosmopolitan.com/health-fitness/a8038748/male-birth-control-study-stopped/>.
  19. “This is how the Bimek SLV works.” Bimek. Accessed 2018: <https://www.bimek.com/this-is-how-the-bimek-slv-works/>.
  20. Angela Colagross-Schouten, Marie-Josee Lemoy, Rebekah I. Keesler, Elaine Lissner and Catherine A. VandeVoort. “The contraceptive efficacy of intravas injection of Vasalgel™ for adult male rhesus monkeys.” Basic and Clinical Andrology Journal officiel de la Société d’andrologie de langue française. 27(4). (2017): <https://bacandrology.biomedcentral.com/articles/10.1186/s12610-017-0048-9>.
  21. Niloufar Ilani, Mara Y. Roth, John K. Amory, Ronald S. Swerdloff, Clint Dart, et al. “A New Combination of Testosterone and Nestorone Transdermal Gels for Male Hormonal Contraception.” The Journal of Endocrinology & Metabolism. 97(10). (2012): 3476–3486. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462927/>.
  22. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception.” US National Library of Medicine. (2018): <https://clinicaltrials.gov/ct2/show/NCT03452111?term=Nestorone+Testosterone&rank=3>.
  23. Belluz, Julia. “The 3 most promising new methods of male birth control, explained.” Vox News. May 4, 2018. <https://www.vox.com/2018/4/4/17170262/male-birth-control-explained>.

This article was previously published in Pussypedia and is reposted with permission.