Don't Hold Your Breath Waiting for Male Birth Control
At least if the history of women's contraception is any indicator.
Between 1963 and 1976, as birth control became a movement, researchers identified 20 new drugs as potential contraceptive agents. Of those 20, 17 made it to human clinical trials. But of those 17, manufacturers submitted only three to the FDA for approval, and only two were approved.
Today, just two drugs compose nearly all forms of available birth control: synthetic versions of the hormones estrogen and progestin, used in female contraception methods like the pill, the patch, the shot, and hormone-releasing IUDs. Fifty years since these hormones were developed, there are no new contraceptive agents on the market.
Nonetheless, many media articles on male birth control promise progress. The latest, supposedly most promising development in male contraception is the vas deferens injection Vasalgel, but it's a fitting example of our grossly inaccurate expectations. In 2015, the manufacturer said Vasalgel would be on the market by 2017. Now, in 2017, the latest news is "This Condom-Free Male Birth Control Just Passed Its Toughest Test Yet." That "tough test" was 16 monkeys. Vasalgel will need at least three rounds of human clinical trials—in hundreds of American men for several years—before the FDA would even consider approving it. Vasalgel "could soon be on the road to FDA approval in the US," Wired reported in 2011. Six years later, it's hardly close.
Condoms have evolved from animal intestines to latex. But other male contraceptive methods are still in the dark ages. Why? One reason is understandably onerous regulations. Birth control faces particularly stringent clinical trial requirements from the FDA because it will be used in millions and millions of mostly healthy people for the majority of their reproductive years. The ParaGard copper IUD, for example, underwent seven-year studies in beagle dogs and monkeys before even starting human clinical trials. Likewise, it will take years to demonstrate that male birth control is safe and effective for longterm, daily use.
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Proving that male birth control is as safe and effective as existing female birth control will be an additional hurdle, particularly because men aren't the ones risking pregnancy. Remember the male birth control study that researchers ended early due to side effects? Hormonal side effects, like mood changes, were seen in greater rates among these male subjects than typical female birth control users. That increased risk is hard to justify for users and for the FDA. For example, the FDA will often truncate or expedite applications for breakthrough drugs that have no equivalents. All other drugs—like, undoubtedly, male birth control—are subject to stiff clinical requirements and a painstaking approval process.
The high stakes of daily drugs with inevitable side effects in otherwise healthy people may explain why the FDA de facto requires foreign clinical trials for birth control to be repeated in Americans prior to approval. That's another step, more money, and more time. For example, Vasalgel was conceived in India, where a version of it is substantially further along in clinical trials than in the US. But none of this research can be used in lieu of US data for FDA approval.
Male birth control may also be slow to materialize in part because it doesn't have motivation or money from Big Pharma. In fact, pharmaceutical investment in male birth control has been virtually abandoned since 2006. Christina Wang, a UCLA professor and renowned male contraception researcher, told me that there's currently "no big or even medium-sized pharmaceutical company that's interested in the development of male contraception."
Wang believes that pharmaceutical companies aren't interested in developing male or female contraception because of liability concerns. These fears may stem in part from the lethal Dalkon Shield IUD in the 1970s, which in turn bankrupted its manufacturer with lawsuits. "[Big pharmaceutical companies] much prefer to be involved in cancer treatments, in things to treat your high blood pressure, diseases, rather than prevention of pregnancies," Wang says. It goes back to risk: Big Pharma would rather treat sick people with the hopes of curing them than healthy people with the hopes of not making them sick.
Due to high risk of lawsuits, American product liability insurance is also through the roof. These costs, in addition to the mind-boggling cost of clinical trials, can disincentivize smaller manufacturers from entering the male contraception market at all. Without Big Pharma backing them, researchers have to take other, slower routes to market. Wang's contraception research is currently fully supported by the US government, which is also incidentally "almost the only one supporting" female contraception. The problem is the government can only take pharmaceutical developments so far. "The US government still needs someone to market the product. That is not the work of the government," Wang says. For now, the government is trying to find industry partners. As research develops, interest will follow, Wang says. "All we have to do is push forward."
Unfortunately, sheer drive doesn't always work. This was the strategy of the 76-year-old Indian inventor of the Vasalgel technology, whose patents have long expired. Decades after developing this innovative contraceptive, he's been unable to find a company to market and sell his product in India.
Big Pharma may never be on board with new contraceptive developments. One-time, cost-effective injections like Vasalgel directly undermine profits of daily methods like the pill. Besides, since Big Pharma already has a lucrative hold on the contraception market, male birth control may simply not be a priority. So with regulatory railings and lack of manufacturer muster, how far off are we really? "We always say about five to ten years," Wang tells me, and laughs.
One early phase longterm study using hormonal methods is planned to start in August of this year. That will need to run for at least two years in at least 1000 men before FDA approval is a remote possibility. However long that takes, other methods not requiring hormones—like Vasalgel—will take "many, many more years," Wang says. "We're always hoping in ten years we'll get one. We have to get one."
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