On October 27th, 2016 the Journal of Clinical Endocrinology & Metabolism announced through a study that we are one step closer to a FDA approved, hormonal, reversible, male birth control.1 This is the largest study on male injectable birth control, which researchers have hailed as a breakthrough.
The Phase II study was set in ten international testing centers. Phase II’s priority was to test the safety and efficacy when a mixture of progesterone and a synthetic version of testosterone was injected into the 320 participants. These participants were healthy males between the ages of 18-45, in long term sexually active, monogamous, relationships with females, and underwent sperm testing to ensure normal levels. This study resulted in a 95.9% suppression of spermatogenesis to less than 1 million/mL (for non sciencey people- that’s really good!). The contraception was deemed effective in 96% of the couples, and only four pregnancies occurred during this efficacy phase.
After Phase II ended, an external safety review committee associated with the World Health Organization recommended the discontinuation of injections due to numerous side effects including, “acne, injection site pain, increased libido, and mood disorders.”1
Of course these are similar to the side effects women have been reporting since the advent of female contraceptives in the 1950’s.
If you have been scrolling through your newsfeed this past week, you probably noticed a backlash against discontinuing the study. A media narrative arose, claiming that the men themselves ended the study by dropping out. Headlines have surfaced from magazines such as USA Today’s “Male Birth Control Study Nixed After Men Can’t Handle Side Effects.”4 Though this anger is ill placed on the men experiencing side effects, it is nonetheless understandable. The long history of the development of birth control is muddled with sexism, classism, and even eugenics.
Biologist George Pincus and Dr. John Rock developed and tested The Pill in the 1950’s and 60’s.3 Due to America’s strict contraceptive laws, initial tests were conducted on poor Puerto Rican women without their full knowledge of the drug’s potential and actual side effects. Three women died during the study (their bodies were never autopsied so cause of death remains in question), and many women dropped out. 17% percent of participants experienced side effects such as “nausea, dizziness, headaches, stomach pain, and vomiting”2 Once women began dropping out, the male researchers found women they could force to sterilize in American asylums and in medical schools. Despite outrageous side effects, the same formulation of The Pill was released as “Enovid” in 1957 on the American market, “right before a sweeping 1961 overhaul of the FDA’s drug approval process”5 Pincus and Rock looked into developing hormonal control for men.
They decided not to due to the risk of side effects.
Fear that this study was stopped due to a historically embedded sexist set of research standards is well founded. Male hormonal contraception is now being held to different standards than those in existence when female hormonal contraception was developed. However decades later, in light of our modern ethical and research standards of medicinal development, it is right to stop the study.
One of the reasons cited for discontinuing the study was that side effects were reported heavily from Indonesia. Most significantly, 62 out of the 65 reported emotional disorders were from men in just this one testing center. This was true for 69 of the 103 reports of injection pain and more than half of the reports of increased libido. There is a strong possibility that the study itself was conducted in a flawed manner at this location.
Furthermore, it was reported that one man (apparently unrelatedly) committed suicide due to school stress and one man (apparently relatedly) attempted to commit suicide. Notably, several men did not regain their normal sperm count for over a year. One man did not regain it for four years. Reports of an abnormal fast and irregular heart beat, increase in breast size, and excessive sweating were unwanted effects related to the study. In accordance with ethical research standards, the quantity and varying quality of side effects combined with a possible flaw in the study itself was enough to stop and reassess.
Scientists have not “given up” on this breakthrough research like many media outlets are claiming. In fact, the journal states that 75% of men would like to continue their injections.1 When pharmaceutical companies hear that statistic… all they hear is “$$$” (and we all know pharmaceutical companies hold the real power here). For scientists, this will be an important time to assess quality improvement. Researchers have already indicated how they might tinker with the hormone levels or modify the injection schedule to eliminate, “prolonged terminal elimination half life”1, which may be disordering mood.
When Enovid was first released it contained 10 times more than the minimum amount needed for efficacy. The drug levels and the debilitating side effects were not reduced for over two decades. We study history to learn from our past and improve our future, not to inflict onto others what was inflicted onto us. Yet it appears that this is what some media outlets are calling for. Why not seek to reduce the hormonal levels now to reduce side effects for the men we care about? Why not seek to better understand pharmacokinetics now, in order to prevent increased risks of suicide and depression? We must aim to raise the standard of eliminating side effects for both women and men. Enforcing rigorous bioethical and research practice standards here is a step in the right direction for everyone.
In the meantime ladies, brace yourselves for taking hormonal contraceptives for approximately another ten years and for putting pressure on pharmaceutical companies and the FDA to simultaneously improve the standards for our contraceptives.
No one is going to do for us.
References:
Behre, H., M. Zitzmann, R. Anderson, D. Handelsman, S. Lestar, and R. McLachlan. "Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men." The Journal of Clinical Endocrinology and Metabolism, October 27, 2016. Accessed November 4, 2016. doi: 10.1210/jc.2016-2141.
Squires, B. "The Racist and Sexist History of Keeping Birth Control Side Effects Secret." Vice. October 17, 2016. Accessed November 4, 2016. https://broadly.vice.com/en_us/article/the-racist-and-sexist-history-of-keeping-birth-control-side-effects-secret
Friedman, A. "How the Pill Overcame Impossible Odds And Found a Place in Millions of Women’s Purses." New Republic. October 3, 2014. Accessed November 4, 2016. https://newrepublic.com/article/119569/pill-overcame-impossible-odds-found-place-millions-womens-purses
Hafner, Josh. "Male Birth Control Study Nixed After Men Can’t Handle Side Effects." USA Today. November 2, 2016. Accessed November 4, 2016. http://www.usatoday.com/story/news/nation-now/2016/11/01/male-birth-control-study-nixed-after-men-cant-handle-side-effects-women-face-daily/93088124/.
Kaskpark, A. "Un-Contraceptive." Snopes. October 31, 2016. Accessed November 4, 2016. http://www.snopes.com/male-birth-control-study/.