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This Cracked article makes the following claim:

Take, for instance, a recent male birth control trial. When participants started to drop out because of side effects, the World Health Organization became concerned. When one subject's depression got so severe that they attempted suicide, the project was (rightfully) shelved. It's worth noting that these exact phenomena have been observed -- and at a greater magnitude -- in women taking birth control. The very same side effects that halted the trial in males are considered par for the course for females.

Is this statement accurate?

Arghya Saha
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dsollen
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  • Symptoms of the Pill that I've heard include weight gain, bloating, and moodiness (basically the same as PMS), but not severe depression. –  Apr 18 '17 at 17:31
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    @fredsbend: Current trials, no. Early trials... they used much higher dosages. And yes, the side effects were worse. – Sean Duggan Apr 18 '17 at 18:09
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    http://www.snopes.com/male-birth-control-study/ isn't a bad place to start reading about what the side effects were and the differences between FDA tests in the 1960s and tests today. – Sean Duggan Apr 18 '17 at 18:10
  • The one side effect I know of that showed up in the male trial that I have not seen any reference to happening in the female trials was prolonged reduced fertility and at least one case of, what has been thus far permanent, sterility. – Sean Duggan Apr 18 '17 at 18:16
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    @SeanDuggan Do you have a source? Because the study itself doesn't seem to mention that. – tim Apr 18 '17 at 19:07
  • @tim: https://heatst.com/world/that-male-birth-control-trial-youre-all-laughing-about-left-people-infertile/ "Of the 320 participants, one guy was rendered infertile by the treatment – four years after finishing the injections he had not recovered a normal sperm count. A total of eight men (2.5% of the study) were not back to “normal sperm counts” a year after they stopped the shots (page 4 of linked study)." – Sean Duggan Apr 18 '17 at 19:38
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    From the linked study: "Eight participants had not recovered to meet the criteria of return to fertility after 52 weeks in recovery phase, the last visit according to the study protocol. These participants were followed on a case by case basis until they regained normal sperm counts (n = 5, up to 74 wk of recovery) or declined further follow-up (n = 2). One volunteer did not recover within 4 years since his last injections." – Sean Duggan Apr 18 '17 at 19:44
  • @SeanDuggan Thanks. Regarding "prolonged reduced fertility", the question is what the expected time frame is (for some female birth control it is also rather long). Regarding the 1 person who did not recover: I'm not sure why that isn't listed as adverse event. But as long as it's not, and as long as we don't have more information on it, I think we can't draw too many conclusions based on it. – tim Apr 18 '17 at 19:50
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    @tim: Frankly, I think the situation is more that we're more critical about side effects these days. It's like the old saw about how Tylenol would never pass today's trials. I mean, a product that has been shown to cause irreversible liver damage at just double the recommended dosage? It was different times. – Sean Duggan Apr 18 '17 at 19:59
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    It's a Cracked article. They often deliberately exaggerate the facts. Cracked stories tend to use extreme hyperbole and exaggeration for comic effect. – barbecue Apr 18 '17 at 20:12
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    @barbecue - I heard them talking about this, specifically, on NPR's "Science Friday" when they were talking about the male contraception, specifically, and the guest talked about the trials being canceled and how the symptoms that led to it were the same ones that women undergo as part of the use of approved female contraception. So, it's not just Cracked hyperbole, though you are right about them, in general. Hopefully that wasn't the source for the science reporter they were interviewing! – PoloHoleSet Apr 19 '17 at 17:51
  • It's only an n of 1, but I had violent mood swings when trying to take a contraceptive pill in the 1990s, and bled continuously for a year on Norplant (an early long-term hormonal contraceptive, eventually pulled from the market). I was told by my doctor that the mood swings were "normal" and would *probably* go away if I stuck it out for a couple of months (I didn't). – 1006a Apr 19 '17 at 21:48

2 Answers2

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The study of male birth control is publicly available and lists the reasons for the cancellation:

[The decision to cancel] was based on RP2’s review of study AEs [adverse events] and conclusion that the risks to the study participants outweighed the potential benefits to the study participants and to the increased precision of the study outcome findings from having the full cohort contribute to the final analysis.

The AVs of concern to the RP2 were reports of mood changes, depression, pain at the injection site, and increased libido.

The whole list of adverse events and their percentage is listed under "AEs and discontinuation of injections". 4.7% were affected by altered mood, 2.8% by depressed mood or depression, 23.1% by pain at the injection site, and 38.1% by increased libido. Not all of these are definitely related to the birth control.

The question already linked to the study showing a correlation between hormonal contraception and the use of antidepressant. According to the NIH, a side effect of female oral contraceptives can be depression or mood changes (uncommon). Here is a study that showed an increase, but there are also studies that show a decrease in depression with contraceptive use. Here is a review of studies that is inconclusive about a link.

The linked Atlantic article names Liletta (an IUD) as example. According to the manufacturer, depression or depressed mood affect 5.4% of users, 5.2% are affected by mood changes.

A review of studies showed that 22% of users of female contraceptives showed an increase in libido, and 15% showed a decrease. There may be contraceptives which increase libido more, and others which increase it less.

Pain at the injection side is difficult to compare to the various contraceptive options offered to women.

Conclusion

It is true that the study of male birth control was canceled because of observed side effects, but a direct comparison of the severity of side effects of different birth controls is difficult.

There is at least one female birth control product on the market that itself states adverse side effects that are comparable to those of the male birth control in question, at least regarding depression and mood changes. Regarding increased libido, a review of studies has shown that female birth control on average increases libido at half the rate of the male birth control.

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tim
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    The side-effects may've been cause for a larger concern than their own undesirability. For example, if a car makes funny noises on startup, those funny noises may be little more than annoying, but they may be taken as evidence of a larger problem. – Nat Apr 21 '17 at 04:38
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    Also worth noting that the business motivations can be different when it comes to a market first, e.g. a male contraceptive. A poor reception for a new type of pharmaceutical could potentially __(1)__ sour consumer perceptions; __(2)__ fail to lay the groundwork for institutional support, e.g. insurance companies would feel less pressure to cover male contraceptives as aggressively, further hurting adoption; __(3)__ give government regulators more excuses/reasons to hold up future products and trials. – Nat Apr 21 '17 at 04:46
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    Pretty late, but: "a direct comparison of the severity of side effects of different birth controls is difficult" -- why? It seems to me you did a very good job there. – dasWesen Jan 18 '20 at 19:06
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There's probably a lot going on here. I like Cracked but they're not above some oversimplifications for the sake of a punchline.

The ethics of clinical trials involve (among much else) an evaluation of the risk of the trial compared to the risks of the condition which the trialled therapy is intended to treat, in the individuals enrolled in the trial. Among women, pregnancy has tons of risks, including depression, pain and mood swings. Very likely, for all the risks of even the first-generation birth control pills, they saved lives relative to the contemporary risks of pregnancy. There are no directly corresponding risks in men. Perhaps there is some non-zero suicide rate associated with unwanted fatherhood but I've never heard it presented as a major health hazard. Obviously the trials made it through ethics approval, but the point is, birth control is really not the same for men as it is for women.

But it doesn't sound like any ethics board shut the trials down; it sounds like the trials were cancelled because a lot of subjects dropped out. A high dropout rate is a big problem for trials; even if you can keep a large enough cohort to get decent stats, you have the risk that you're now basing results on a self-selecting sample, and that could (and should) be a red flag when it comes to getting approval. "Our new drug is very well tolerated by those who didn't find it intolerable." Cracked could have had fun on either side of this one.

And it doesn't bode well for marketing: if these eager volunteer early adopters won't take the stuff when it's free for them, who the heck is going to stay on it at retail prices.

There's also the matter that we're a heck of a lot more careful with new drugs today than we were in the '60s when the Pill came out. By today's standards, a lot of early clinical trials would likely have been shut down.

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  • "Perhaps there is some non-zero suicide rate associated with unwanted fatherhood" Perhaps also a non-zero murder victim rate by the person impregnated and/or her family. – reirab Jun 25 '17 at 06:25
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