This headline is horribly editorialized. Can we have it changed to "Male Birth Control Study terminated due to safety concerns"?
Of note, 75% of the trial participants reported that they would have continued with this treatment if it were available, even after being informed that it was being terminated due to safety concerns, and the (male) study participants reported being more satisfied with the treatment than their (female) partners did.
Conversely, the adverse events extremely high rates of changed (mostly increased) libido, mood disorders, and pain (both at the injection site and elsewhere); and out of 320 trial participants there were two attempted suicides (one successful -- which the researchers attributed to academic pressure, but suicides rarely have a just a single cause). If the female birth control pill had the same safety profile, it would be the leading cause of death in 20-45 year old women.
(along with the helpful sub-tag, "Welcome to the club, dudes. Also: WOMAN UP.", along with a weepy picture from Dawson's Creek).
Welcome to the club, dudes. Also: WOMAN UP.
"From the study: "Of these 20, 6 men discontinued only for changes in mood and 6 men discontinued for the following single reasons: acne, pain or panic at first injections, palpitations, hypertension, and erectile dysfunction." The other eight men dropped out because of mood changes. "
I can't quite tell from this if it's 6, 8, or 14 men who dropped out due to mood changes. Overall, 20/320 dropped out of the study, 6.25%. I did a bit of research and found that median attrition rate for drug studies is 7%, but median isn't especially helpful since effects can vary.
The percentage who dropped out due to mood changes are (it's hard to tell from this well written article) 6/320, 8/320, or 14/320, so somewhere between 1.8%-4.3%.
This becomes the headline "Men Quit Birth Control Study". That's one of the charitable headlines, honestly. The fact that it morphed into this headline, to me, kind of is the story here.
I do think there's clearly a problem with suicide, especially among men, and I do think this is because, to some extent, men are particularly concerned about appearing weak and failing to get help. So a round of mockery about this is also painful to see.
I know this is going to sound snarky, but I really am genuinely asking: why? They have a history of very blatantly pushing their political agenda, most people seem to acknowledge that NPR is pretty left leaning. This doesn't seem out of place for them at all.
People have been playing a lot of political football with this story. I saw a Facebook post making the rounds saying that this cancellation proves once again that women tolerate pain better than men. And these women sharing the story and having a laugh were medical professionals. Yes, really! It's pretty absurd that our society still can't have honest, open, and adult discussions regarding reproduction and sex, even among the supposedly educated.
If the pill had any sort of side effects like what these drugs had, they'd be the leading cause of death for women 20-45. But no, it's "weak willed men". meh.
And even after the study was cancelled due to safety, 75% of the men wanted to continue taking it. I guess its worth personal safety and health versus the risk of having a pregnancy with a woman when you don't want one.
That was the title I saw as well since I had NPR in my news feed. I removed it now. There is just so much of this SJW post realism disregard for facts that I can take just because they decided to push some Alt Left agenda.
It's a pity because some years ago NPR used to be a balanced and excellent source of news.
Good grief NPR. Does the bizarre interpretation in TFA reflect something institutional? Should we suspect similar editorializing on every report in which men's and women's interests might be somehow be misunderstood to oppose each other?
If it's based on the one suicide and extrapolating to a death rate of 0.3%, I'd call it a bit of a stretch. Yes that would make it the leading cause of death if it did continue, but given the tiny sample size and single occurence (which may or may not be related), I don't think you can draw any conclusion.
Given that uncertainty concluding the study to work on the drug before trialling it again makes a lot of sense.
Extrapolating from one death + one failed suicide attempt + a large number of mood disorders. ezzaf is quite right that you shouldn't extrapolate from the one death alone, since that might have simply been a statistical fluke (although even one suicide is outside of the 95% range for this population and duration of study), but it becomes far more statistically powerful when supported by other side effects which are known to strongly correlate with suicides.
> If the female birth control pill had the same safety profile, it would be the leading cause of death in 20-45 year old women.
Out of curiosity, is this taking into account that the base rate for male suicide in the US is normally ~3.5x higher than for female suicide? Seems like you'd want to calculate a relative risk delta, rather than comparing the male delta to the female base rate.
Not leading cause of suicide; leading cause of death. He's saying if this thing killed those two men, that's 1/320, which is (wayyy) more than poison (top 1 currently for 25-34, ~1/10000). You'd need to adjust for how many women actually take the pill; after a cursory glance a conservative estimate seems to be 10%, but please don't quote me on that.
I think my comment still applies. It's not reasonable to imagine that women would be subject to a male death/suicide rate by taking this drug. Gender has a larger effect on those rates than the drug likely does.
Women are actually more likely to attempt suicide. Men are more likely to succeed because they tend to use more violent methods (e.g. firearms vs pills).
But yes, depression is a common side effect of female hormonal birth control too. Women who start the pill are twice as likely to subsequently start taking antidepressants as those who aren't on the pill.
No, I didn't take that into account. You're right that the suicide rate might be inflated in part because men are more prone to suicide to begin with; but even if you adjust for that, you'd be looking at a drug which would be as dangerous as smoking.
Depending on where the demographics you would expect as high as 1 successful suicide per 5,000 men per year. So, randomly having a successful subside in a 320 person study is not that unlikely. Unsuccessful suicides are more common. So, there is not really enough data to suggest a strong link.
Most likely the other side effects where the issue.
But if the treatment appears to cause severe mood swings in some cases, would that not suggest there's a good chance that it was a factor in the two suicide attempts (one successful)? Or is it counterintuitive?
There is a good chance, yes. And it's probably a good reason to stop this trial if that was completely unexpected. But I don't think that that's the last we will hear of this treatment if there is a market for it, which there seems to be.
For example, Isotretinoin https://en.wikipedia.org/wiki/Isotretinoin (known as Accutane/Roaccutane and by other names) is also associated with depression and suicidal behavior. It's still a popular drug used to treat acne, even though that is not a particulary dangerous disease.
I don't know anything about how the pharma industry works, but I'd guess they'll restart the trial, taking depression into account and watching for signs among the participants. And maybe with a lower dosage?
Yes, I strongly suspect that isotretinoin is responsible for my very soon after developing a chronic pain disorder and mood swings. After talking to others afflicted by chronic pain it turns out to be a rather common factor :( there's even a pretty plausible mechanism of action (to do with inflammation, which if you've ever been subject to the stuff, I suspect won't surprise you in the least...)
Had I known about any of this (to be clear, I just mean the risk - not my actual outcomes. No predictions of the future necessary) prior to taking it, I'd never have considered it.
Of note, 75% of the trial participants reported that they would have continued with this treatment if it were available, even after being informed that it was being terminated due to safety concerns, and the (male) study participants reported being more satisfied with the treatment than their (female) partners did.
Conversely, the adverse events extremely high rates of changed (mostly increased) libido, mood disorders, and pain (both at the injection site and elsewhere); and out of 320 trial participants there were two attempted suicides (one successful -- which the researchers attributed to academic pressure, but suicides rarely have a just a single cause). If the female birth control pill had the same safety profile, it would be the leading cause of death in 20-45 year old women.