Sexism in clinical trials

Scientists have discovered an effective male birth control. Studies have proven that it worked, yet injection was discontinued based on some manageable side effects. So manageable in fact that over 75 percent of the study participants said they would be willing to use the shot as their primary birth control method. The risks were milder than those faced by women using birth control pills, so why are risks to men’s health treated more seriously than risks to women’s health?

Although both genders are equally responsible for pregnancy, women most often bear the burden of prevention. According to the US Centers for Disease Control and Prevention, nearly 11 million women take a birth control pill every day. Although they have been around for six decades, the pills still come with a lengthy list of side effects ranging from acne to depression to life-threatening blood clots. For men, the currently available birth control options are limited to condoms and sterilization, both of which have few side effects.

Pharmaceutical companies, most of which are run by men, claimed social reluctance discouraged scientific research and a male pill is scientifically more challenging to create. The United Nations Population Fund, or UNFPA, co-sponsored a study on a male birth control shot and scientists went forward with the idea and created a method of hormonal male birth control.

According to the Endocrine Society’s website, a study published in the Journal of Clinical Endocrinology and Metabolism on October 27, 2016 began several years ago when 320 men aged 18 to 45 in monogamous relationships agreed to receive injections every eight weeks of a long-acting progestogen to suppress sperm counts. Once the sperm counts were verified to be low, the men were asked to stop using other forms of contraception. The injections were 96 percent effective and only four pregnancies occurred. In comparison, injectable female birth control is 94 percent effective according to the CDC, while the pill is 91 percent effective likely attributable to human error.

Twenty men discontinued the study due to side effects, mostly related to mood swings, depression and acne. These side effects are exactly the same as those that women’s birth control pills cause. According to Elisabeth Lloyd, a professor of biology and philosophy at Indiana University Bloomington, the study on a male birth control was cancelled based on the fact that 6 percent of the men in the study complained of significant side effects. As with the pill, fertility returned when the injections ended.

While depression in up to 6 percent of the men was deemed so unacceptable that important medical research was terminated, depression in 20 to 30 percent of women related to birth control pills is acknowledged as a necessary evil, and simply treated with antidepressants. A recent study by the University of Copenhagen found that in one million women aged 15 to 34 with no prior history of depression, those on hormonal birth control pills were 23 percent more likely to be prescribed antidepressants. Critics are quick to point out that the Danish study published in JAMA Psychiatry in November 2016 did not show that the pill caused depression, only that there is a worrisome association. Yet rather than noting that this same analysis is true for the male birth control injection study, “coincidental side effects” resulted in cancellation of the study.

Time and again, there seems to be a disparity in the balance struck between issues impacting women and those same issues when they impact men. For women, nausea, mood swings, headaches, bloating, acne, vomiting, blood clots and strokes are acceptable risks, and the benefits of the pill outweigh the side-effects. For men, mood swings, acne and muscle pain experienced by approximately 6 percent of the men was so unacceptable that an otherwise successful study was terminated. six percent is the cutoff for men while 20 to 30 percent is acceptable for women.

“Contraception targets women. It has side effects and men are just weenies,” said medical ethicist and author Arthur Caplan, PhD. “They are unwilling to do anything that might either make it less fun, or put them at any kind of risk when it comes to birth control.” It is not surprising that the study was terminated. “The history of birth control has almost always focused on women,” Caplan said. “It’s reflected in the science, which is dominated by men who bring their stereotypes with them, knowingly or not.” Caplan is head of the Division of Medical Ethics at New York University Medical Center.

Women can roll their eyes and sigh but it’s time for everyone to acknowledge that women’s health and health options are equally important. If side effects are acceptable for the goose, they are acceptable for the gander. The reciprocal is equally true, and it’s time we all acknowledged the disparity and fought for meaningful equality.

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