Birth Control for Men: Will Big Pharma Stand in the Way of this New Contraception?

Birth Control for Men

The onset of birth control was met with tremendous disdain. Women like Margaret Sanger were jailed for even sharing information about contraception. She believed that women should be “the absolute mistress of [their] own body” and fought to make it so. Her publication, The Woman Rebel, led to her indictment for violating postal obscenity laws. She later opened the first birth control and family planning clinic of its kind, resulting in multiple jail sentences. Her fight led to tremendous progress, and Sanger’s work influenced many, including Katharine McCormick: “biologist, suffragist, philanthropist and, after her husband’s death, heir to a substantial part of the McCormick family fortune,” which led to the funding of the very first oral contraceptive.

In 1954, with McCormick’s funding, Gregory Pincus and John Rock began tests that were extremely unethical. Some tests utilized women who had not given consent; others forced mentally ill hospital patients to participate; and others were conducted in Puerto Rico to avoid anti-birth control laws, subjecting female test subjects to a drug with unknown side effects. By 1960, the first oral contraceptive, Enovid, was approved by the U.S. Food and Drug Administration (FDA)—but only for married couples. It wasn’t until 1972 that all women had legal access to birth control. Although condoms became legal in the United States in 1918, this was the first time women had a choice in the matter.

Fast forward to present day. Birth control has made monumental strides forward from the first oral contraceptive, where women have several options to choose from and men have…well, they still have the condom. In recent years there have been quite a few think pieces about why that is. If history has taught us anything, the patriarchy has little concern for women’s reproductive rights; in fact, the original oral contraceptive was meant for men but was rejected due to the various side effects.

The only reversible contraception option for men since the 1850s has been the condom. We’ve all heard the critiques of condoms: They interrupt intercourse, reduce sensation, and have a pregnancy rate of 18% over a year for couples who use condoms as their primary contraception method. That’s more than a one in six chance unwanted pregnancy could occur! Withdrawal (“pulling out”), on the other hand, has a 20 percent failure rate. In the age of casual sex, that’s huge.

Birth Control for Men Big Pharma

The only other option for men is the ol’ snip snip! A vasectomy is designed to be irreversible, and just as women want control over their reproductive organs, men want the same autonomy over their bodies—and futures. Once a woman is pregnant, it is her choice whether or not to give birth to that child—as it should be. Giving men a more stable, trustworthy option for birth control/contraception will enable men to play a more active role in planning and pregnancy, creating equitable parenting practices from the start.

Sujoy Guha, professor emeritus at IIT-Kharagpur in West Bengal, India understands this better than most. He’s dedicated half of his life to RISUG, an acronym for “reversible inhibition of sperm under guidance,” a male contraceptive that forms a polymer inside the vas deferens—the small duct that sperm flows through to get to the penis, the same duct cut during a vasectomy. This effectively blocks sperm from the testicles to the urethra without affecting orgasm or ejaculation. Not only is it non-hormonal, meaning men won’t have to deal with the same effects caused by female birth control pills (nausea, breast tenderness, headaches, weight gain, mood changes, missed periods, decreased libido, vaginal discharge, depression, blood clots, death), it is easily reversible. Once a man decides he is ready to have a child, all that is needed is a second injection of sodium bicarbonate (baking soda) to flush out the polymer in the vas deferens, allowing semen to flow freely once again.

Guha and his team effectively made it to phase II human trials with no side effects reported when the Indian Council of Medical Research interfered—again. Guha believes the delays have come from the National Institutes of Health in the U.S., claiming the NIH were promoting a pill similar to female birth control pills, as hormone-based drugs (needed to be taken regularly by users, rather than a one-time injection) would see better profits. Whether this is true or not, Guha has not given up. “Why should the burden be borne by the female only?” Guha wonders. “There has to be an equal partnership.” Other foundations from around the world are thankfully beginning to see the potential of RISUG. In 2010, the Parsemus Foundation acquired the rights to produce RISUG, and the World Academy of Biomedical Technologies similarly showed interest in making the drug for France, Germany, Hungary, Italy, the UK and possibly Greece and the Ukraine.

The US-based Parsemus Foundation’s version of RISUG is called Vasalgel, which has a longer shelf life and, according to Ben Carlson at the Parsemus Foundation, they are now preparing for the first contraceptive efficacy clinical trials in humans by the end of 2018. As the FDA doesn’t recognize results from clinical trials overseas, the Parsemus Foundation was unable to pick up where Guha left off, but they have successfully demonstrated efficacy in monkeys and rabbits, as well as shown successful reversibility in their rabbit study. Vasalgel is now on to human trials.

“We regularly hear from men who are eager to participate, so we’re hopeful that recruitment will not be too hard,” states Carlson. The main hurdle the Parsemus Foundation faces is not recruitment or public interest, however, but funding. “We want to make Vasalgel as widely available and affordable as possible,” Carlson continues. “The global contraceptive market is expected to be $33 billion by 2023, and is rapidly growing. Our review of related research gives us the impression that demand is sufficient for our efforts to be worthwhile and for investors to have a reasonable expectation of recouping their investments.”

Although Carlson seems confident, Guha highlights a valid point. Big Pharma is inclined to fund drugs that people need to continually use (like The Pill), making for continual revenue. Vasalgel has the potential to cost less than the syringe used to inject it, and is a ‘one-and-done’ solution for a long period of time. “Our primary fundraising focus right now is to find social investors,” Carlson emphasizes. “Investors for whom public benefit is part of the bottom line.” Investors like the Male Contraception Initiative.

The Male Contraception Initiative does internal research, collaborates with other organizations and directly funds early-stage research. The MCI also helps researchers connect with investors and pharma companies. Aaron Hamlin, Executive Director of MCI, doesn’t believe there is a lack of interest in male contraception options and seems just as—if not more—confident than Carlson regarding the progression of Vasalgel. “For one, the market is enormous,” Hamlin notes. “The introduction to one doesn’t mean the replacement of another one. They can complement each other. A lot of that is going to depend on what the relationship between two people is like in terms of what they are using [for contraception], how effective it is and how it works for their relationship.”

According to Hamlin, the benefits of having male contraceptive options are vast, from environment and population issues to gender equity. “If the male pill were introduced to the market,” Hamlin describes, “we would see, on a conservative end, about 186,000 unplanned pregnancies averted each year. With something like Vasalgel, you’re looking at a number of about 274,000 unintended pregnancies averted each year in the U.S.”

The numbers Hamlin quotes are from “Contraception,” an MCI study. “The way to really disrupt [the birth control] market is to demonstrate that you have a long-acting, reversible contraceptive that can be reversed after years,” explains Hamlin, which is Vasalgel’s ideal trajectory. According to a survey done by babe, 82% of men said they would take a male contraceptive if it was widely available. Men are looking to have more control over their reproductive future, and not having to worry about a condom breaking or their partner potentially missing a pill would take the stress out of safe sexual encounters.

Birth Control for Men Big Pharma

Not only would something like this give women in monogamous relationships the option to rid themselves of the hormonal and sometimes dangerous side effects of birth control, it would set a new standard for responsible, equitable family planning. Right now there are 3.2 million unintended pregnancies in the U.S. every year. That means that almost half (49%) of all pregnancies in the U.S. are not planned.

Vasalgel is a non-hormonal, long-lasting and reversible male contraceptive, and the only thing standing in the way of this drug hitting the market within the next few years seems to be cash-money. Americans spent $6.5 billion in federal money and $4.6 billion in state public funds on the births of unintended babies in 2006. If appealing to the public’s benefit is not enough for investors, these numbers should be telling to the potential for profit.

It is our hope that profit margins won’t be the deciding factor in creating healthier birth control options. Although female birth control has been a step in the right direction, women have put themselves at risk ingesting hormones and suffering the side effects common to The Pill. The Parsemus Foundation has acknowledged this gender disparity, leaving the door open for donors to help fund their work if drug companies won’t. A more equal, ethical future is possible. Will Big Pharma stand in the way?