Suspended and Unsuspended Birth Control Trials: Equipoise, White Feminist Nonsense and Conditional Humanity

Since scientists suspended clinical trials of a male birth control shot, my social media feed has been full of white feminist outrage with a side of transmisogyny and racism.  Actually, the veiled racism and erasure of history is a main event, not a side dish, and so we really need to break this down.  I’ll start with the clinical trial itself, and why it was suspended. And then, we take down white-washed history and problematic white feminist objections. So you know where I’m headed.

But first, let’s address the utter nonsense that is the assumption of two genders, only.  I want to shout this one: Gender is not a mother-fucking binary.  It just isn’t.  Gender is a goddamn spectrum, or a spiral, or some shape that hasn’t yet been named.  To say otherwise is to dismiss the millions and millions of people who are multiple genders, or no gender, the millions of trans men who have ovaries and vaginas and the millions of trans women who have dicks and testicles, the millions of people who are intersex, or gender-queer, or non-binary.  And while erasure of anyone sucks, it is downright dangerous to deny the very existence of a group of people who have such incredibly high rates of  being the victim of violence.  Interpersonal violence, intimate partner violence, the state-sanctioned violence of civil rights denials, police refusal to respond to hate crimes against gender-variant people and targeting inside prisons and immigrant detention facilities.  The medical violence of painful surgeries on non-consenting intersex children, the lack of access to gender-affirming treatment and the social stigma, and the violence of repeated misgendering and erasure.  Trans women of color have an average lifespan of 35 years due to all the violence they face.  35 years.  Let that sink in.  And so we cannot talk about gender as a binary, as male or female only, because to do so is to perpetuate more violence, and that is unacceptable.  It’s also unscientific.  And we need to keep this in the forefront of our minds when we discuss the  suspended “male” birth control trial.

The study itself began in 2008, and an external research review committee decided to stop it much earlier than planned, in 2011.  A few days ago, the authors published their results in an article titled Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men in an endocrinology journal.  So it’s in the news.  The study was evaluating a new birth control method targeting people who produce sperm.  Participants in the study received an injection of testosterone every eight weeks, which raised their overall testosterone levels enough that their testicles were tricked into stopping their own production of testosterone.  When the testes are no longer producing testosterone, they also stop producing much sperm.  Lowered amounts of sperm being produced means much lower chances of sperm meeting egg.  This is the same principle behind hormonal birth control for people with wombs, in that artificially high hormone levels make the body believe its already pregnant, which shuts down ovulation (the production of mature eggs that can meet a sperm and become a fetus).

Preliminary results showed that the testosterone shots were very effective at lowering sperm counts, and the researchers concluded that the method was about 96% effective at preventing pregnancy.  A total of 320 people were included in the study.  After a little over a year of receiving injections, participants were followed to see if their fertility returned.  All but five people had their sperm counts return to normal levels after stopping the shots.

But, and this is important, there were side effects. The most common side effects were pimples, increased sex drive, pain in the injection site after the shot, and mood disorders, including depression.  In total, 65 out of the 320 participants reported that they experienced depression.  Interestingly, most of the cases of depression came from a single testing site in Indonesia, though there were 9 other clinical sites also testing the injections.  This is important, too, because how we understand depression and other emotional health issues is incredibly cultural.  It could be that people in other countries like the United Kingdom, Australia or Germany were more likely to subscribe toxic masculinity and the associated idea that naming depression is shameful.  We will come back to cultural ideas about depression in a little while.

In research-speak, side effects are called adverse events, or AEs. Anything bad that happens to a research participant while the study is going on is considered an AE and must be reported to an external research review committee.  AEs are divided into categories based on their severity.  In this study, 91% of AEs were considered mild, the lowest category.  There were still a lot of AEs though, over 1400.  AEs are also analyzed by whether they could possibly be related to the study; this is the principle that I could be enrolled in a study about contraception and get hit by a bus tomorrow.  My bus accident would be unrelated to my contraception use, but it would still be reportable as an AE.  In this study, 38.8% of AEs were determined by this external review committee to be bus accidents unrelated to the study.  So all in all, there was a high rate of AEs, but a fair number of them were unrelated to the study itself.  And the vast, vast majority of all AEs were mild.

Due to the high number of AEs, the external research review committee made the decision to stop the study early.  In my news feed, white feminists are complaining about “men being wimpy” (see gender notes) and dropping out of a study that was making them experience shit women (see gender note) go through every day.  Many of the posts I read are outraged, but some are almost sisterly, dripping with the tactic agreement that women are here to take the blows because individual men can’t handle it, to the point that they leave the study.  This is patriarchal, binary thinking that portrays individual men as bumbling and weak without taking down the toxic masculinity and misogynist systems that weaken us all. And that’s not what actually happened.

Here’s what actually happened: Every research participant has the human right to stop their participation in a research study at any time they want.  In this study, 20 individuals exercised this option due to the side effects they were having.  However, the decision of these 20 individuals to stop participating is categorically different from the external committee’s decision to stop the entire study early.  First of all, no individual research participant has the power to stop an entire research study for everyone.  This is especially relevant when we think about who is recruited into research studies, particularly studies that test a new medication.  Drugs have side effects, and people with the advantages of class, income and privilege are much less in need of the cash incentives necessary to cause people to expose themselves to these side effects.  Said another way, the well-paid scientists doing research are so much less likely to ever be research participants, and there is a giant power differential between research participants and researchers.

This power differential is why external research review is so, so important.  And an external research review committee found that this study had too many side effects to ethically continue it.  Not individual men, an external review body.  Participants in the study were marginalized individuals in need of cash, which references differential access to resources and global inequity, not wimpiness.  Let’s stop hating on them-300 out of 320 participants did not drop out.  And let’s be clear, patriarchy and toxic masculinity are the real things to hate on here.

Next, the ethical principle that caused the external reviewers to stop the study early is called equipoise.  Equipoise simply means that the potential for good must be at least equal with the potential for harm. In this case, because the risk of side effects was so great, the external reviewers felt that the equation was no longer balanced, and the potential for harm was greater than the potential for good.  Equipoise is a human right; otherwise, we are harming people in the name of science. Other ethical principles that are important to the human rights of people and communities that participate in research are justice, or the idea that the people who are exposed to the risks of the research should be the same people who benefit from it, and respect for persons, the principle that the human rights of research participants are of the utmost importance, and trump the ned for new scientific knowledge.

But, and here’s where shit gets intersectional, the question is not whether research participants should be entitled to the human rights of equipoise, justice and respect for persons.  It’s who has been granted equipoise, justice and respect for persons. In other words, its about who researchers and the research establishment consider human enough for human rights.

Let’s compare the preliminary study to develop testosterone-based birth control with the preliminary study to develop the estrogen-based birth control widely known as the pill.  Beginning in the 1960s, when synthetic estrogen was first developed, scientists wanted to test this birth control on married white women in the mainland U.S.  In  Boston, white women were enrolled in  a preliminary clinical trial, much like the testosterone study we’ve been talking about.  White women experienced significant side effects, and the study fell under intensive scrutiny.  And it was suspended, again a lot like the testosterone study.  Married white women in the U.S. in 1960 were entitled to equipoise, justice and respect for persons.  They were seen as human and their side effects were seen as just  that, side effects.

And so, when the preliminary study in Boston was shut down, contraception research moved to Puerto Rico, where women were coerced and tricked into serving as experimental subjects.  And they were seen by people in power as just that, experimental subjects, not research participants, not human beings with human rights.  They experienced a huge, huge burden of side effects, none of which were reported as AEs, or reported at all.  After a series of experiments that left many, many people permanently sterile, ill and even dead, estrogen-based contraception was brought to the mainland U.S. and sold to white women at much lower doses.  The high, high rates of side effects experienced by people in Puerto Rico highlighted the fact that the amount of hormone in the pill needed to be lowered to reduce human suffering.  Because, and let’s be real, human suffering was and is defined by people in power as white suffering.

Lest you say that times were different, this was not the case for white women in Boston.  That study was suspended due to side effects.  The side effects were side effects when they happened to white women.  They were not even notable when they happened to Indigenous and Latinx women living in a colonized land.  Same time frame, wildly disparate standards.

And lest you say the issue here is gender and sexism, I’m going to direct you to the vast, vast majority of contraception research that has been conducted, often coercively, on women of color living in colonized lands.  Colonizers have a direct interest in limiting population growth in the lands they invade, because a large population can more easily overthrow a colonial regime.  Imperialists have a vested interest in describing the problems they cause as the fault of their victim’s fertility.  As in, you are not living in poverty because I stole your resources; you are living in poverty because you have more kids than you can feed, and you exercise your human right to being a parent.

If we focus on limiting the fertility of people living in poverty, we can maintain the fiction that they are literally replicating their own poverty, independent of colonizers’ thievery.  If limiting indigenous fertility is codified as a poverty reduction strategy, coercive contraception research becomes a means of serving the public good.  So few of the contraception experiments conducted in colonized lands are even described as experiments-they were poverty reduction programs.  And people receiving these charitable poverty reduction programs do not have the human rights afforded to research participants, because their humanity is not certain, is even conditional on whether or not they make the “good decision” of participating in the “poverty reduction program” that is mass experimentation and testing of contraceptives on people living with the impacts of imperialist agendas.  The issue here is not gender, it’s racism and imperialism.  Pure and simple.

This isn’t about side effects.  This is about humanity, and whose humanity is recognized by researchers and other people in power.  I’m willing to stake my meager research associate and visiting adjunct professor salary on the fact that people in Puerto Rico, India, Ethiopia and Guatemala experienced side effects, too.  I willing to wager everything that they experienced vast human suffering as a result of their coerced participation in research (and I do mean research, not imperialist poverty reduction programs).  But their suffering was not an adverse event, or even notable.  It was expected and uneventful, because that is how racism  and imperialism work.  And this is a cycle we need to disrupt.

This is a cycle we need to fucking disrupt.  We need to stop talking about the 20 wimpy men who exercised their human right to withdraw from harmful research, and we need to stop complaining about an external research review committee doing their job and protecting the human rights of human research participants.  We need to be outraged instead that people in power in research and elsewhere don’t view all people who participate in research as human enough to have human rights. We need to be upset that external research review committees are not shutting down any study that cause human suffering.  We need to start seeing the suffering of people of color in colonized lands as human suffering, and as a gravely adverse event.

Oh, and the recent study that so many well-meaning people in my news feed are touting as “finally” demonstrating that there’s a connection between depression and use of estrogen-based birth control? The study that is supposed to spur action to evaluate the safety of estrogen-based birth control? It was an incredibly white study; it was Swedish for pete’s sake. So you know whose depression is now finally real and notable? White people’s.  Same old racist narrative.

We can do better, y’all.



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