
Male birth control study cut short as some participants experience side effects - happy-go-lucky
http://www.npr.org/sections/health-shots/2016/11/03/500549503/male-birth-control-study-killed-after-men-complain-about-side-effects
======
artofcode
Also important to note that permanent infertility is quite a strong side
effect

> 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.

[http://press.endocrine.org/doi/pdf/10.1210/jc.2016-2141](http://press.endocrine.org/doi/pdf/10.1210/jc.2016-2141)

~~~
sean_patel
> One volunteer did not recover within 4 years since his last injections.

That's a really STEEP Price to Pay for an "experiment". Anyone know how much
the participants were compensated for taking part in the study? No amount of
money would make me do something like this. But that's just me.

~~~
milkytron
To answer you question, I do not know what they were compensated. But I
suppose if you already had the amount of children you wanted and were
considering the ole snip snip, this might have been a considerable option.
Maybe it's what they wanted? I do agree though that if this were a young man,
I sincerely hope they made some frozen samples before committing to this
study.

~~~
evandijk70
There's also the risk that the drug is not as efficient as expected, and you
end up with an unwanted pregnancy, so participating in this trial is never a
no-brainer.

~~~
morsch
Presumably they were strongly advised to use a second method of birth control.

~~~
askmike
in that case they wouldn't really test whether it works or not..

~~~
sangnoir
I don't think they were measuring the efficacy on the basis of whether or not
the participants conceived - that measure is affected by too many variables.
Sperm count is the more reliable metric with reasonable granularity for
measuring the effect.

------
positr0n
I wonder why they didn't mention vaselgel [1]. When I first heard about it a
couple years ago it was pitched as an injection of $0.10 of chemicals into the
vas deferens that would block sperm from traveling through it. They were
hoping it would last 10 years, be reversible with another small injection, and
be available in the U.S. in half a decade. A non-profit is funding the
research and their goal is for it to be affordable even in developing
countries.

[1]:
[https://www.parsemusfoundation.org/projects/vasalgel/vasalge...](https://www.parsemusfoundation.org/projects/vasalgel/vasalgel-
faqs/)

~~~
StanislavPetrov
>I wonder why they didn't mention vaselgel [1]. When I first heard about it a
couple years ago it was pitched as an injection of $0.10 of chemicals into the
vas deferens that would block sperm from traveling through it.

Because how are pharmaceutical companies going to make billions from selling
$0.10 of chemicals?

~~~
gohrt
With a patent on a formulation and delivery method. Most patented drugs sell
at huge multiples of production cost.

~~~
smallnamespace
They can't patent it very easily if someone else invented it. Otherwise you'd
see people trying to patent 'formulations' of their competitors' drugs all the
time.

Even if they could patent a formulation, someone else can always jump in with
a slightly different formulation at half the price.

------
StefanKarpinski
The rates of serious side effects were much higher than any female birth
control currently on the market [1]:

> Nearly a quarter of participants experienced pain at the injection site,
> nearly half got acne, more than 20 percent had a mood disorder, 38 percent
> experienced an increased sexual drive, and 15 percent reported muscle pain.
> Other, rarer side effects included testicular pain, night sweats, and
> confusion. One study participant died by suicide, though the researchers
> determined it wasn’t related to the birth control. Twenty men dropped out of
> the study because of the side effects.

[1] [http://www.vox.com/2016/11/2/13494126/male-birth-control-
stu...](http://www.vox.com/2016/11/2/13494126/male-birth-control-study)

~~~
cup
I think thats the point a lot of people miss. Yes, standards are far more
stringent today and we take better care of individuals during clinical trials.
That doesn't change the fact though the bulk of responsibility for birth
control falls on women and the history of birth control is particularly nasty
and cruel.

~~~
mioelnir
Personally, I think if there was a birth control option for men that was even
remotely in the same ballpark as the pill in terms of effectiveness,
reversibility and pre-plannability it would easily equal or surpass the pill's
usage rate.

~~~
krisroadruck
if they came out with a monthly pill or a 90 day shot in the arm for men, the
birthrate in this country would plummet nearly overnight. Right now men really
only have 3 non-permanent birth control options and all of them suck:

1) Bag over the dick - makes sex less enjoyable

2) Fully trust your partner to not "forget" to take her birthcontrol or lie
about being on it in the first place.

3) Abstinence.

I'm not suggesting all women or even a significant percentage of women are
evil liars. However, there have been many studies & surveys that have
indicated nearly half of all women are willing to lie about contraception in
order to get pregnant, regardless of their partners wishes, and fully half
have said that if they became pregnant by another man but wanted to stay with
their partner, they would lie about the baby’s real father.

I'd much rather know for sure by taking personal ownership of birth control
myself.

~~~
UncleMeat
But would you take a 90 day shot if it meant experiencing depression, serious
cramps, and genital bleeding for long periods of time?

I don't know a single woman who has been happy on a single form of BC for a
long time. My fiancee was on the implant until she started bleeding and didn't
stop for _five months_.

~~~
krisroadruck
In my case I went full bore and got a vasectomy. I literally let someone take
a scalpel to by boys so yeah.. cramps? sure.

Genital bleeding is really a very gender specific thing. Women already bleed
from their genitals the issue is that it is now prolonged. If a man started
bleeding from the penis that'd probably be a fairly serious condition lol. I
get your point though. That said discomfort is a perfectly reasonable trade to
avoid 18+ years of responsibility and a financial cost currently estimated at
$250K per child (not including opportunity cost mind you)

------
nothrabannosir
_But these are healthy men — they 're not going to suffer any risks if they
get somebody else pregnant._

I don't believe what I'm reading. Give up your life as you know it or live
with the guilt of "not being there", + the social and financial stigma that
comes with it?

No risks? You must be joking.

~~~
rgbrenner
I read it as "health risks"... because of the context of the paragraph

~~~
inimino
What does "but these are healthy men" have to do with it? That paragraph is
just poorly worded.

~~~
mattkrause
Clinical trials typically have something called a Data and Safety Monitoring
Board, which periodically reviews safety (and, occasionally efficacy) data to
decide if the trial should be halted prematurely. The DSMB is supposed to
consider the potential benefits to the individual subjects and the population
from which they're drawn, and weigh that against possible risks from the drug
and the trial (e.g., complications from biopsies).

Since the subjects here are otherwise healthy men, who have other options for
avoiding pregnancy, the DSMB should be fairly risk adverse and willing to kill
the trial (as happened here). If, on the other hand, the trial were testing a
new kind of anti-cancer therapy on patients with terminal cancer, the Board
might be willing to tolerate a few more adverse events because the pay-off s
are much higher.

The article seems to be saying, in a ham-fisted way, that the DSMB would have
tolerated _slightly_ more risk to women because pregnancy also carries its own
risks.

------
jjcm
Removing the comment since it was misleading - I was under the impression that
testosterone supplements increased aggression, but apparently the study that I
linked [1] had some flaws. See crimsonpowder's comment as it has more to date
studies on this.

[1]
[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3693622/](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3693622/)

~~~
crimsonpowder
Since steroids are demonized, I had to make a throwaway account. Testosterone
does not increase aggression, even when given in doses far above natural
limits. [1] [2]

When I'm not programming, my hobby is bodybuilding. To make it as a
bodybuilder, you have to use steroids. With a sample size of ~30 (fellow
lifters and me), I can tell you that more testosterone makes you calmer,
leaner, and bigger. My stress and anxiety on steroid cycles vanishes and all
that's left is confidence, even with powerful steroids like trenbolone.

This study was designed by some of the most incompetent people around.
Athletes inject long esters every 3-5 days and these guys were doing a shot
every 8 weeks. Athletes take additional drugs to control the conversion of
testosterone into estrogen (the hormone behind acne and mood swings). If I had
designed this protocol, it would've looked like standard Testosterone
Replacement Therapy (TRT) plus an injection of nandrolone decanoate every week
(which is great because it heals your joints). Of course, good luck selling
bi-weekly injections.

For decades we shouted about reefer madness from the rooftops, arrested
millions of people and threw them in jail, and expanded corrupt government
agencies because marijuana was "dangerous". It seems like we're learning our
lesson on that front and I hope we get our act together when it comes to
hormones.

[1]
[https://www.ncbi.nlm.nih.gov/pubmed/8855834](https://www.ncbi.nlm.nih.gov/pubmed/8855834)

[2]
[https://www.ncbi.nlm.nih.gov/pubmed/12062320](https://www.ncbi.nlm.nih.gov/pubmed/12062320)

~~~
chris_7
> To make it as a bodybuilder, you have to use steroids.

Does this not disqualify you? Or is everyone just cheating like in cycling?

~~~
crimsonpowder
There are divisions that are tested--monthly polygraphs and urine/blood.
You've never heard of them. When people think about bodybuilding, they imagine
freaks, which is not a natural state.

In software, we say: good, fast, cheap; pick two. In bodybuilding: big, lean,
natural; pick two.

You can have a lot of mass and if you carry extra fat, or you can be shredded
to the bone and carry a lot less lean mass. Naturally, the lower fat reserves
run, the higher the chance that catabolic hormones break down lean mass. If
you want to be big, lean, and win shows, you need to take the growth and
steroid hormones to flip some bits on the config files in your
muscular/adipose tissue to allow it.

Your DNA is the software for your body. Hormones bind to receptors on cells,
get transported into the cell, bind to internal receptors, and then this
complete structure moves into the nucleus where it transcribes certain DNA
sequences into RNA chains that will be fed through ribosomes to produce
proteins (your hardware).

Steroids/hormones (everything from vitamin D to testosterone) is the body's
mechanism of editing /etc/* and calling kill -HUP on select daemons. Steroids
evolved as the process for doing this because it's biologically impractical to
grow a nerve ending to every single cell in the body.

------
Sukotto
Compare to "RISUG" (Reversible Inhibition of Sperm Under Guidance). Which
_appears_ to be completely safe and 100% effective. Requires a single, out-
patient procedure (two injections, not counting anesthetic). And is easily-
reversible.

Article:
[https://www.wired.com/2011/04/ff_vasectomy/](https://www.wired.com/2011/04/ff_vasectomy/)

Previous HN discussion:
[https://news.ycombinator.com/item?id=2602785](https://news.ycombinator.com/item?id=2602785)

------
Pxtl
Meanwhile social networks are all atwitter with women relentlessly mocking the
study because the side-effects sound familiar to women, because the articles
vaguely phrase it as "sexual side-effects, emotional changes, cramps" and the
like, not "one of the participants comitted suicide and another is infertile".

~~~
cauterized
And side effects of birth control options for women commonly include severe
depression (yanno, the kind that induces suicide) and more rarely
complications that can cause permanent infertility (septic infections due to
punctured uterus).

~~~
Pxtl
Yes, but a suicide an infertility in a sample of 300? In a 1-year trial?

It's a matter of degrees.

------
ropiku
Vox has more info on this: [http://www.vox.com/2016/11/2/13494126/male-birth-
control-stu...](http://www.vox.com/2016/11/2/13494126/male-birth-control-
study)

The study was terminated after serious safety concerns. Over half of
participants reported adverse effects.

------
tcj_phx
I previously posted about taking out my sperm production using 'the old heat
methods':

[https://news.ycombinator.com/item?id=11934396](https://news.ycombinator.com/item?id=11934396)

That post was 137 days ago was... June 19, 2016. I had verified on about May
15, 2016 that I was azoospermic, and stopped the aggressive heat treatments on
that date. I had used a variety of testicle-heating interventions for about 4
months. My sperm were completely gone for 2 months, then slowly started to
return.

I intend to get a professional sperm analysis at the six month mark (November
15th), then redo the heat protocol, collecting more data this time... I
suppose I need some better slides.

~~~
tkp
Is there a way to follow your experiments ? What heating method are you using
? Have you developed a technique to evaluate your spermcount yourself ?

would be very interested to discuss more, send a mail if you like
hn(a)tokiop(dot)com

~~~
tcj_phx
> Is there a way to follow your experiments ?

not yet... I'll have to figure something out I guess.

> Have you developed a technique to evaluate your spermcount yourself ?

there's a new centrifugal sperm count device... ahh, here:
[https://trakfertility.com/shop/trak-male-fertility-
testing-s...](https://trakfertility.com/shop/trak-male-fertility-testing-
system/) (oh my, those 'refills' are expensive...) Thanks for the jogging my
memory about that.

This device is new to the market - it launched some time this fall, iirc. I
bought a microscope: "yup, no sperm".

I'll send you an email tomorrow.

~~~
tkp
great, thanks for your reply, trak looks expensive indeed.

I am considering using a microscope too, interesting to know that the
difference is clearly visible. Do you use any coloring ?

------
macey
Can we agree that birth control of all kinds has a long way to go? Both men &
women should have the option to be in control of their reproductive rights.
Neither men nor women deserve to experience serious side effects from the
exercise of those rights.

Some lucky folks can take hormones with very little effects. I (F) have had
very negative experiences with hormonal birth control, I'd be bummed for
anyone else to go through it.

~~~
teslabox
> Some lucky folks can take hormones with very little effects.

There aren't any actual 'hormones' in birth control. These drugs are
supposedly hormone-analogues, but they are only partial replacements for
genuine ("bio-identical") hormones.

------
ThrustVectoring
A big missing point in this story: acceptance criteria for medicine in general
is stricter now than when hormonal birth control for women was approved for
use.

~~~
cmdrfred
Also the word complain in the title should be report the whole point of a
study is to identify side effects.

------
ioquatix
> But these are healthy men — they're not going to suffer any risks if they
> get somebody else pregnant.

This assumes that healthy men don't give damn. Which, I don't think is
entirely true.

~~~
wyager
It's also stupid given that men are on the hook for child support in the event
of an accidental pregnancy.

------
cauterized
The side effects experienced by the men in this study are not to be taken
lightly. They're scary and dangerous.

They're also no worse than the side effects (from depression severe enough to
cause suicide to life-threatening complications and yes, permanent
infertility) that women on various forms of birth control have put up with for
the past several decades. And continue to endure.

And even in studies not about birth control, women's medical complaints and
concerns about side effects have been shown to be taken less seriously by
medical professionals than men's similar concerns.

Your sister, girlfriend, date. That woman you saw on line at Starbucks. They
may not all be experiencing those side effects (neither did all the men in the
study). But they're all risking a LOT to avoid pregnancy. Today. Right this
moment.

Ask yourself why those side effects and risks are OK for them to bear but not
for you. Ask where the research is on female birth control without those
risks.

I'm not saying this study should necessarily have continued. Just that there's
very good reason for the bitterness.

If you want to understand the female perspective on this news, try the below
opinion piece:

[http://m.huffpost.com/us/entry/us_5818f13fe4b0922c570bd335](http://m.huffpost.com/us/entry/us_5818f13fe4b0922c570bd335)

~~~
hubert123
Jesus christ, how about if women dont like it, they can stop taking it? There
are plenty of alternatives, none perfect as Im sure you are eager to point
out.

~~~
user5994461
Most women only take birth control when they're in an active relationship.

Men seem to ignore that.

~~~
huehehue
Though, from a planned parenthood rep

> Birth control can have non-contraceptive benefits as well, so plenty of
> people use it regardless of their level of sexual activity or pregnancy
> risk. For example, my dermatologist prescribed birth control pills when I
> was a teenager to help clear up my torturous pizza face – the pregnancy
> prevention part was a total bonus when I became sexually active later. Other
> methods, like the hormonal IUD, can reduce and sometimes even stop menstrual
> bleeding and/or cramps, a side effect that lots of folks appreciate.

------
kzisme
Seeing this and other stories like this posted on other forms of social media
are frustrating since many females were voicing opinions that males are
"weak/afraid/not able to deal with" birth control like they can.

>There's been a lot of eye rolling on the Internet about these side effects,
because women have been experiencing things like mood swings and weight gain
for decades with hormonal birth control.

------
DRMacIver
This piece by Dr Jen Gunter provides some better perspective on this study I
think: [https://drjengunter.wordpress.com/2016/11/01/new-study-
doesn...](https://drjengunter.wordpress.com/2016/11/01/new-study-doesnt-show-
men-are-wimps-about-contraception-side-effects-low-vasectomy-rate-might/)

Short version: The study is interesting but the early termination is largely
ethics review working as intended and does not mean that all research into
this method is terminated or that the results weren't promising.

------
gigatexal
lol the headline doesn't clickbait hard enough. Some participants became
sterile... that's a bit more serious than simply quitting because of some
"side effects".

------
smoyer
My wife was on birth control the first nine years of our marriage (excluding
the gaps when our kids were born) and I've been responsible for the birth
control for the last twenty years. That seems like a pretty fair distribution
of the responsibility to me.

~~~
gohrt
Years is a strange unit of responsibility. What were the methods, how do they
compare?

Some methods are ongoing maintenance with side effects, some are permanent
with varying short-term side effects.

~~~
Gibbon1
I'm assuming his wife was on hormonal birth control while they were starting
their family and once they were done he had a vasectomy.

Someone sane pointed out that the problem isn't the men in the study being
wimps. Or that frankly there isn't any good drug target for male hormonal
birth control. But that vasectomy rates are much lower than they should be.
Because if you want something cheap, extremely safe and reliable, and you
don't mind it being permanent, vasectomies are what you want.

~~~
smoyer
I purposely left the "means" ambiguous but you're 100% correct. It was also my
intention to point out that BC is a concern of a couple ... If you're talking
about avoiding pregnancy during anonymous sex then the only logical stance is
that both should be on BC since they can't really trust the motivations and
diligence of their partners.

------
steveplace
They injected test without an AI to control the side effects.

~~~
mrlase
Context for those who are unaware of what an AI is: AI is an aromatase
inhibitor that stops the aromatization of testosterone into estrogen.

~~~
Gibbon1
What bothers me about this far as I understand the drug doing the 'work' has
bad side effects when given to men. Not as in some percentage of men, but 100%
of the men will have unacceptable side effects.

So they're also adding other drugs to try and compensate for those. And of
course that doesn't work very well.

~~~
mrlase
Which part? Letrozole, anastrozole, and exemestane (the three biggest AIs) are
all incredibly effective at keeping estrogen levels within range given a
knowledgable doctor providing supervision.

The biggest problem is that there is a lot of taboo with testosterone
treatments and finding a doctor that keeps up to date with the research is
incredibly difficult depending on where you are located.

------
eveningcoffee
I have been thinking about it lately.

I am not including my judgement, as I do not have any, well, at least not a
well reasoned one.

Disclaimer: I am man.

I try to list some of the possible fears related to this kind of drugs. Then
it would be possible to discuss these.

1) Loosing control of emotions.

2) Permanent infertility.

3) Impotence (temporal or permanent).

4) Unknown risks.

Now these are simple straightforward issues that possibly could be resolved
with additional research.

What will remain are more subtle issues. Nonetheless these could considerably
affect the fabric of our society.

For example consider the situation where most women are fertile, most of the
men have disabled themselves, some of men have kept themselves fertile.

------
seanwilson
>

~~~
girvo
I believe there were two suicide attempts, one successful?

------
stomato
Ow

------
cperciva
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_.

~~~
Hello71
the original was worse:

> Male Birth Control Study Killed After Men Complain About Side Effects

because... a man literally killing himself is complaining.

edit: "original" meaning TFA. the submission title here was a slight
improvement, something like "Male Birth Control Study Ended Due To Side
Effects"

~~~
kefka
There's your "feminists" for you.

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.

------
benmw333
In this day in age of PC, you'd think NPR would pick a less offensive title
for this article. It screams feminism.

------
known
[https://en.wikipedia.org/wiki/Condom](https://en.wikipedia.org/wiki/Condom)
have no side effects

~~~
antihero
Problem solved then!

