Comparing Birth Control Trials Today to Those in the 60s Ignores a Sea Change in Research Ethics

Vox has a wonderful article on the recently published male birth control study that is a useful corrective to the narrative that falsely equates it to the original studies of The Pill. Though I say ignore their title, too, because it’s also not that helpful of a narrative either. But the content is useful in arguing against what seems like a terrible and callous framing of the study in most commentary. The key line: “And, yes, the rate of side effects in this study was higher than what women typically experience using hormonal birth control.” Also, can we point out if something like 10 women a year at a school like UVA were committing suicide and it might be linked to a medication they were taking, people would probably be concerned? There’s something disturbing about well-off American women mocking these effects that seemed to disproportionately affect men of color (the most side effects were reported from the Indonesian center, followed by the Chilean center).

My bigger concern here, though, is that most people seem to not understand (or are basically ignoring) how modern research ethics works. For instance, the notion of benefits being weighed in the evaluation of continuing the study aren’t merely the potential benefits of the treatment, but the added benefit of acquiring more data. This was an efficacy study (so I think Phase II, or maybe it was combined Phase I/II, although it might be a really small Phase III trial). It seems like the institutional review board felt enough data had been collected to reach conclusions on efficacy that more data didn’t justify the potential high rate of adverse effects. Which also DOES NOT mean that this treatment has been ruled out forever. The authors themselves recommend further development based on the 75% of participants claiming they would use this birth control method if it were available. I imagine they will tweak the formulation a bit before moving on to further trials. Also, it’s sort of amusing that complaints on this come from people who typically think moves toward regulatory approval are controlled by Big Pharma at the expense of patient health.

Yes, this is different than the initial birth control trials. Yes, the women of Puerto Rico were chosen as human guinea pigs. Though it’s worth pointing out another major factor in choosing Puerto Rico was that it actually had a pretty well organized family planning infrastructure in the 50s and 60s. Admittedly, there’s more racism almost certainly coming into play there, because the politics of family planning were super complicated through the early and mid 20th century and there were definitely overlaps between eugenics and family planning. It’s also worth pointing out the study was encouraged by Margaret Sanger (and earlier studies by Planned Parenthood). Also, the FDA didn’t even initially approve Enovid for contraception because the atmosphere was so repressive back then on reproductive health; it was for menstrual disorders but prescribed off-label for contraception, which is why we know so many women desperately wanted the pill. Heck, even the Puerto Rico study was nominally about seeing if the pill helped with breast cancer. It took another year of discussion by the researchers and companies to get the FDA to finally approve contraception as an on-label use. The company making the pill was actually so concerned about the dosage causing side effects they begged for FDA approval for a lower dose just for contraception (see page 27-28 there) but were rebuffed for another year or two and they refused to market the initial dose for solely for contraception. (Also, to clarify, no one is taking these medications anymore. These versions of the pill were phased out in the 80s.)

Was there sexism at play? Absolutely, and I totally get that. But that doesn’t mean the narrative from 2016 neatly maps onto the narrative of the 1950s and 1960s. Which brings me to my last point. If your view of research ethics is primarily colored by the 1960s, that’s terrifying. You know what else happened at the same time as the initial contraception pill studies? The US government was still letting black men die of syphilis in the name of research. The tissue of Henrietta Lacks was still being cultured without the knowledge or consent of anyone in her family. (And the way they were informed was heartbreaking.) People were unknowingly treated or injected with radioactive material (one of many instances is described here in the segment of testimony by Cliff Honicker). One study involved secretly injecting healthy people with cancer cells, and to prove a theme, those cells were descendants of the ones originally cultured from Henrietta Lacks. Heck, there’s the Milgram experiment and then the Stanford Prison Study was in the 70s. The ethics of human experimentation were a mess for most of the 20th century, and really, most of the history of science. Similarly, medical ethics were very different at the time. Which isn’t to justify those things. But don’t ignore that we’ve been working to make science and research more open, collaborative, and just over the last few decades, and people seem caught up in making humorous or spiteful points than continuing that work right now.

(Other aside, it’s worth pointing out that the comparison here probably does have to be to condoms, which you know, skip the side effects though their typical effectiveness rate is worse. Most of the methods don’t obviously change ejaculate, so unless measuring sperm concentration and motility is a couple’s idea of foreplay, sexual partners who don’t know each other well will still probably want a condom [or unfortunately another method, because yes, the system is sexist and women are expected to do more] as assurance. It’s worth pointing out the study design only worked with “stable” couples who were mutually monogamous and planned on staying together for at least a year during the duration of the study, so there presumably was a high degree of trust in these relationships.)

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