10 ms·

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 fertil

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

daodedickinson 10y ago
YIKES It could be something that would have happened anyway... right? I am not an expert :P.
- smsm42 10y ago
  It's almost always a factor in such trials, AFAIK. Since it's live people that have their own lives and bodies, it could be that it happened for unrelated reasons. However, there are standards of risk and I guess "possibly makes males permanently infertile" was not an acceptable risk.
sean_patel 10y ago
> 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 10y ago
  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 10y ago
    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 10y ago
      Presumably they were strongly advised to use a second method of birth control.
      - askmike 10y ago
        in that case they wouldn't really test whether it works or not..
        tveita 10y ago
        It's supposed to lower sperm count, which you could easily verify with a sample.
        sangnoir 10y ago
        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.
      - evandijk70 10y ago
        I looked up the study, and it seems that participants were not allowed to use a second method of birth control: "Couples enrolled in the efficacy phase were asked to rely only on these injections for contraception." And there were four pregnancies during the study (from the abstract of the study): During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59 – 4.14)
        10y ago
- flukus 10y ago
  I assume they would have at least flipped the bill for freezing sperm first.
- Retra 10y ago
  Four years of infertility is probably one of the easier things you should be able to do in life.
  - flukus 10y ago
    It might be permanent infertility.
- gnaritas 10y ago
  Sounds better than a vasectomy for men who want that. Good drug, wrong market perhaps.
  - kbart 10y ago
    I'm not sure that 1/320 probability of success is good for that either..
    - PakG1 10y ago
      Just gotta figure out how to increase the efficacy. :)
- madaxe_again 10y ago
  If this was a side effect their pool was almost certainly vasectomy candidates, and rather than there being compensation, they probably didn't need to pay for their treatment.
  - dogma1138 10y ago
    Vasectomy still allows for IFV at a later date, intertifility doesn't.
    - Benjamin_Dobell 10y ago
      > One volunteer did not recover within 4 years since his last injections. It didn't say his sperm count was actually zero. Generally IVF is still possible when the male is classified as "infertile" by traditional measures (i.e. extremely low sperm count or dysfunctional sperm).
- at-fates-hands 10y ago
  As someone who did Phrama testing in college to help pay my way through school, compensation would be determined by how long the study went on, which the article failed to say: "It was a pretty big study; they gave shots to 320 men every eight weeks, in different countries around the world." Every eight weeks, but for how long? In my experience, it would probably be in the neighborhood of a few thousand dollars, but not much more. For the participants, even that much money to take some pills over the course of say a few months would probably be seen as easy money. But then again, there's those pesky side effects. FYI: All the drugs I tested were already FDA approved and were not considered in a "trial" phase.
- JoeAltmaier 10y ago
  ...if it had anything to do with the study at all. What's the normal rate for infertility to develop in this demographic?
- serge2k 10y ago
  maybe they just picked guys who already had kids. If you are considering a vasectomy anyway then it's not nearly the same problem.
CiPHPerCoder 10y ago
> Also important to note that permanent infertility is quite a strong side effect I know many who would see that as a blessing though: License to have as much unprotected sex as they want without the unfortunate side-effect of an unwanted pregnancy. And they get paid for the experiment in the first place too? Win-win, they would argue.
- elmin 10y ago
  Of course they lost the ability to have wanted pregnancy which is a pretty serious loss for some people.
  - CiPHPerCoder 10y ago
    This is a non-issue for me, but I thought it was a perspective that bears mentioning (since I hear it a lot from heterosexual men).
  - icanhackit 10y ago
    > they lost the ability to have wanted pregnancy Right, but I suspect the parent implied that this could be a feature that many would seek out - basically the chemical equivalent of a vasectomy that can't be undone. Some people, like me, really don't want kids. Taking control of it so that you're not relying on your partner is important as trust (that they haven't forgotten to use contraception or worse - deliberately not take it) isn't a rock-solid security policy. It's also not fair on females to be the only ones in charge of contraception for bare-skin sex.
    - CorpOverreach 10y ago
      Exactly this! If I can take a shot or a pill rather than a scalpel to my balls... sign me up.
      - gaius 10y ago
        But it's an unpredictable side effect. It might just stop working a few years later...
deleted 10y ago
[deleted]
madaxe_again 10y ago
With that as a side effect, surely an elastic band would be a safer and more tried method. Obviously surgery would be better yet, but what they've come up with is literally worse than what we do to sheep.
- falcolas 10y ago
  You mean letting the testes shrivel up and drop off due to cut off blood flow? And it's not exactly painless. The shot's side effects sound significantly more humane.
warfangle 10y ago
Boo fucking hoo. If you really want solid male birth control with no side effects, bank your gametes for $50/mo and get your vas deferens snipped. Female birth control may not cause permanent lack of fertility, but it can cause cancer. Breast cancer. Cervical cancer. Liver cancer.
- coryfklein 10y ago
  > it can cause cancer. Breast cancer. Cervical cancer. Liver cancer. Do you have some idea of the likelihood here? Are we talking a 10% chance of cancer or a 0.001% chance? The whole "it can have X side effect" is the same argument anti-vaccine people use without respect to any sort of cost benefit risk analysis.
  - alexc05 10y ago
    I did a quick Google and it appeared to me that most of the adverse events were measured at rates in the 10's per 10,000 ... Though that is absolutely from a very high level. This study was presenting at around 20% (IIRC, I was reading the outrage version of this stuff a few days ago) It is also important to note that this is by no means the end of the drug. The people involved consider this to be a very promising study and are going to continue working on it. It wasn't stopped early "as a failure" to be shelved and never looked at again. It was stopped early because they knew enough about the upside and didn't have to continue on the down. The next rounds of trials will likely try to alleviate the side effects while preserving the MOA (mechanism of action) The VOX article was a reasonable balance to the "men are selfish pigs who can't handle side effects" version of this article. http://www.vox.com/2016/11/2/13494126/male-birth-control-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu...
- joenot443 10y ago
  >it can cause cancer So can dental fillings, breast implants, and artificial sweeteners. Like female birth control though, most people agree that the risk for developing cancer associated with the activity is well worth the benefits. Saying "boo fucking hoo" about someone who can never reproduce again is pretty cold-hearted, in my opinion.

daodedickinson 10y ago

YIKES It could be something that would have happened anyway... right? I am not an expert :P.

smsm42 10y ago
It's almost always a factor in such trials, AFAIK. Since it's live people that have their own lives and bodies, it could be that it happened for unrelated reasons. However, there are standards of risk and I guess "possibly makes males permanently infertile" was not an acceptable risk.

sean_patel 10y ago

> 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 10y ago
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 10y ago
  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 10y ago
    Presumably they were strongly advised to use a second method of birth control.
    - askmike 10y ago
      in that case they wouldn't really test whether it works or not..
      - tveita 10y ago
        It's supposed to lower sperm count, which you could easily verify with a sample.
      - sangnoir 10y ago
        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.
    - evandijk70 10y ago
      I looked up the study, and it seems that participants were not allowed to use a second method of birth control: "Couples enrolled in the efficacy phase were asked to rely only on these injections for contraception." And there were four pregnancies during the study (from the abstract of the study): During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59 – 4.14)
      - 10y ago
flukus 10y ago
I assume they would have at least flipped the bill for freezing sperm first.
Retra 10y ago
Four years of infertility is probably one of the easier things you should be able to do in life.
- flukus 10y ago
  It might be permanent infertility.
gnaritas 10y ago
Sounds better than a vasectomy for men who want that. Good drug, wrong market perhaps.
- kbart 10y ago
  I'm not sure that 1/320 probability of success is good for that either..
  - PakG1 10y ago
    Just gotta figure out how to increase the efficacy. :)
madaxe_again 10y ago
If this was a side effect their pool was almost certainly vasectomy candidates, and rather than there being compensation, they probably didn't need to pay for their treatment.
- dogma1138 10y ago
  Vasectomy still allows for IFV at a later date, intertifility doesn't.
  - Benjamin_Dobell 10y ago
    > One volunteer did not recover within 4 years since his last injections. It didn't say his sperm count was actually zero. Generally IVF is still possible when the male is classified as "infertile" by traditional measures (i.e. extremely low sperm count or dysfunctional sperm).
at-fates-hands 10y ago
As someone who did Phrama testing in college to help pay my way through school, compensation would be determined by how long the study went on, which the article failed to say: "It was a pretty big study; they gave shots to 320 men every eight weeks, in different countries around the world." Every eight weeks, but for how long? In my experience, it would probably be in the neighborhood of a few thousand dollars, but not much more. For the participants, even that much money to take some pills over the course of say a few months would probably be seen as easy money. But then again, there's those pesky side effects. FYI: All the drugs I tested were already FDA approved and were not considered in a "trial" phase.
JoeAltmaier 10y ago
...if it had anything to do with the study at all. What's the normal rate for infertility to develop in this demographic?
serge2k 10y ago
maybe they just picked guys who already had kids. If you are considering a vasectomy anyway then it's not nearly the same problem.

CiPHPerCoder 10y ago

> Also important to note that permanent infertility is quite a strong side effect I know many who would see that as a blessing though: License to have as much unprotected sex as they want without the unfortunate side-effect of an unwanted pregnancy. And they get paid for the experiment in the first place too? Win-win, they would argue.

elmin 10y ago
Of course they lost the ability to have wanted pregnancy which is a pretty serious loss for some people.
- CiPHPerCoder 10y ago
  This is a non-issue for me, but I thought it was a perspective that bears mentioning (since I hear it a lot from heterosexual men).
- icanhackit 10y ago
  > they lost the ability to have wanted pregnancy Right, but I suspect the parent implied that this could be a feature that many would seek out - basically the chemical equivalent of a vasectomy that can't be undone. Some people, like me, really don't want kids. Taking control of it so that you're not relying on your partner is important as trust (that they haven't forgotten to use contraception or worse - deliberately not take it) isn't a rock-solid security policy. It's also not fair on females to be the only ones in charge of contraception for bare-skin sex.
  - CorpOverreach 10y ago
    Exactly this! If I can take a shot or a pill rather than a scalpel to my balls... sign me up.
    - gaius 10y ago
      But it's an unpredictable side effect. It might just stop working a few years later...

deleted 10y ago

[deleted]

madaxe_again 10y ago

With that as a side effect, surely an elastic band would be a safer and more tried method. Obviously surgery would be better yet, but what they've come up with is literally worse than what we do to sheep.

falcolas 10y ago
You mean letting the testes shrivel up and drop off due to cut off blood flow? And it's not exactly painless. The shot's side effects sound significantly more humane.

warfangle 10y ago

Boo fucking hoo. If you really want solid male birth control with no side effects, bank your gametes for $50/mo and get your vas deferens snipped. Female birth control may not cause permanent lack of fertility, but it can cause cancer. Breast cancer. Cervical cancer. Liver cancer.

coryfklein 10y ago
> it can cause cancer. Breast cancer. Cervical cancer. Liver cancer. Do you have some idea of the likelihood here? Are we talking a 10% chance of cancer or a 0.001% chance? The whole "it can have X side effect" is the same argument anti-vaccine people use without respect to any sort of cost benefit risk analysis.
- alexc05 10y ago
  I did a quick Google and it appeared to me that most of the adverse events were measured at rates in the 10's per 10,000 ... Though that is absolutely from a very high level. This study was presenting at around 20% (IIRC, I was reading the outrage version of this stuff a few days ago) It is also important to note that this is by no means the end of the drug. The people involved consider this to be a very promising study and are going to continue working on it. It wasn't stopped early "as a failure" to be shelved and never looked at again. It was stopped early because they knew enough about the upside and didn't have to continue on the down. The next rounds of trials will likely try to alleviate the side effects while preserving the MOA (mechanism of action) The VOX article was a reasonable balance to the "men are selfish pigs who can't handle side effects" version of this article. http://www.vox.com/2016/11/2/13494126/male-birth-control-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu...
joenot443 10y ago
>it can cause cancer So can dental fillings, breast implants, and artificial sweeteners. Like female birth control though, most people agree that the risk for developing cancer associated with the activity is well worth the benefits. Saying "boo fucking hoo" about someone who can never reproduce again is pretty cold-hearted, in my opinion.