A study on male birth control was halted due to side effects, but that's what's supposed to happen.
Much noise has been made this week about a study on a male birth control injection. The good news is that the hormonal contraceptive worked: it was 96 percent effective at preventing pregnancy in the trial population. The bad news is that it caused a lot of negative side effects, including depression, leading a review board to terminate the study.
If you read the trending headlines on the topic, though, the study was ended because men are big babies who can't handle the mild side effects that women on the pill endure all the time. Others lamented that it perpetuated a double standard. But multiple doctors (and Vox's Julia Belluz) have pointed out that this is straight up inaccurate and also completely misses the point: We all need, and deserve, better birth control.
Some of the criticism stems from the understandable place of anger over the horrendous history of women's birth control testing, which ignored serious health risks in early trials. But that should only be a lesson to us to hold all future testing, for men and women, to higher and safer standards.
"On the one hand, you could look at it as good protocol management that they pulled it, because that's what you're supposed to do," said Christabelle Sethna, an associate professor of feminist and gender studies at the University of Ottawa, and an expert on the history of birth control. "You could look at it as a positive. The reason it's being looked at as a negative is because so many women continue to be on hormonal contraceptive and they're still experiencing side effects."
The most common adverse effects reported by the male birth control study's 266 participants were acne, injection site pain, increased sex drive, muscle pain, and "emotional disorders" (which isn't defined in the paper). No matter how severe or mild you personally think these side effects sound, that wasn't the board's main concern.
The issue was how strikingly common these side effects were for the users: There were 913 reported cases of adverse effects throughout the study that were linked to the contraceptive. Close to half (45.9 percent) of participants got acne, libido increased for 38.1 percent, and 16.9 percent experienced mood disorders. Some participants did drop out, but that's true of every trial, including studies on women's contraceptive, and it's not the reason the review board pulled the plug.
There was also the fact that many of the adverse effects were disproportionately reported from one single trial site, something the review board decided was alarming enough to shut things down.
We can't erase the dark history of women's birth control, but we can learn from it.
When women's hormonal birth control was first being tested, researchers weren't nearly so cautious. The pill was originally tested on mental health patients, then on women in Haiti and Puerto Rico. Despite reports of serious side effects, and even death, trials continued and the drug even made it to market.
"One would think they would have stopped the trials, but they didn't," Sethna told me. "But you also have to remember that, at that time, the protocols were different."
After Barbara Seaman, a pioneer in the women's health movement, sounded the alarm on these side effects in 1970, the pills were altered to lower the dose of hormones, making them much less risky. Women's hormonal birth control still isn't side-effect free, which is why many criticized the fact that this trial was halted, but it's a bit misleading to compare the two.
"You can't compare the findings of a phase 2 trial with the echo chamber of personal experience that is the Internet," wrote Dr. Jennifer Gunter, an OB/GYN, on her blog. "You have to compare study with study, not a study with an op-ed column."
While the pill also comes with some adverse side effects, they're not quite as common as the effects were in this male birth control trial. The most common side effects on the pill are headaches and nausea, which affect about 20 percent of participants, according to information from the Guttmacher Institute, a reproductive health research group. Most other forms of contraception for women are also hormone-based—from IUDs to the patch to the ring—which means they have similar side effects.
The backlash over the study also drew renewed attention to another misunderstood study from September, which found women on birth control were at a higher risk of developing depression. The study found only a very small increase in risk: while 0.28 percent of women not on the pill were diagnosed with depression, 0.3 percent of women on the pill were. By comparison, 2.8 percent of participants in the male birth control study reported depression. Still, the study raised a new, and important, discussion about what kind of side effects to medication are tolerable and safe.
But, as Marianne Baker—a cancer research PhD graduate—wrote to me, we can't decry one birth control for causing a risk of depression while deciding it's an acceptable side effect in another.
"The side effects we may be suffering at a higher rate than men do in this particular study of a new treatment for men doesn't necessarily mean we should expect the same rate in their products," Baker wrote in an email. "The revenge aspect of this, while I understand it, is ultimately not useful to any of us. We need compassion, support, understanding and drive to do better."
Although this particular study was halted due to safety concerns, it doesn't mean there will never be more research done on this contraceptive, or male birth control in general.
Rather than resorting to calling men wimps, we should be glad review boards are doing their jobs, and we should continue to hold them accountable. It's also exciting that the trial showed such high efficacy—and even in spite of the high number of adverse effects, 75 percent of participants said they were satisfied with the injections and would use it again.
We can't erase the dark history of women's birth control, but we can learn from it and avoid making the same mistakes again, whether we're researching new women's contraceptive products or testing out options for men. We all deserve better birth control, and we all deserve to have the full picture of possible side effects, no matter how trivial they may look in a headline.
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