20 ms·

Male birth control study cut short as some participants experience side effects

160 points by happy-go-lucky 10y ago

positr0n 10y ago
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/vasalgel-faqs/ https://www.parsemusfoundation.org/projects/vasalgel/vasalge...
- nothrabannosir 10y ago
  I keep wondering when a reputable source is going to finally cover this and somehow burst the bubble. It sounds too good to be true, yet, somehow, nobody outside their own mailing list seems to acknowledge it. What gives? Is this known quackery? I am weary to get excited, lest I get my dreams crushed yet again :/
  - L_Rahman 10y ago
    One theory for why it isn't acknowledged could be that the creators and trial participants are outside of the Western cultural establishment. The material was discovered and synthesized in India at IIT by a Indian person. The largest clinical trial on Vasalgel - also in India. Media coverage doesn't happen organically. In almost all cases it is a two way street, with networks and personal contacts creating the bridge. The researchers in India and the cultural epicenters of the Western media establishment are about as distant as two nodes can be. Discovery and contact between the two parties is probably very hard. On the other hand if they tied it to a pre-dominant narrative in Western media about India - increasing sexual freedoms or a pathway to population management - and worked with the non-profit institutions that connect back to the nodes of cultural influence in the Western world, they would probably get a decent of amount of earned media coverage.
    - xenadu02 10y ago
      Eh there are reps from the big multinational pharmaceutical companies trolling all over the world for potential drugs, both man-made and natural. Lack of media coverage doesn't mean no one is paying attention.
      - duaneb 10y ago
        If they can't patent it, and it's known to be cheap, it's a race to the bottom in terms of profits. A pill would be far more profitable. I don't think pharmaceuticals would be eager for anyone to find out about it if they can't control the money.
        kyrra 10y ago
        You still have to pay for clinical trials in the US. If the drug can't be patented then no pharma group will pay for the trials if a generic can come along once trials complete and make just as much money.
  - bb611 10y ago
    It's not, but it's far from proven technology. Additionally, it's the exact opposite of most medical research - fairly inexpensive to develop (a few millions USD total), but also with very little profit upside on the other end.
    - lucaspiller 10y ago
      I wonder how many other potential medical treatments fall into this category. If a treatment was found that cured a large percentage of cancers, but was 'too cheap' to develop, would the same thing happen?
      - sleepychu 10y ago
        I think cancer would be a special case. Just because being the ones who came up with a cancer cure would be worth the small investment. Of course the criteria are likely to preclude a cancer treatment!
  - alanh 10y ago
    Valerie Tarico has written about it, and she has her head screwed on straight (which I think means she’s reputable)! She's an excellent writer. However, maybe BuzzFeed needs to do a listicle on Vasalgel, or Cosmo needs to put it in SnapChat, before awareness goes mainstream… that's a sobering thought!
- deleted 10y ago
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- carsongross 10y ago
  If it eventually comes out that this works, the medical establishment and the press in the West have a huge amount of social damage to answer for.
  - cheiVia0 10y ago
    Don't worry, they'll just run a story about a guy who used it and his junk fell off.
- StanislavPetrov 10y ago
  >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?
  - BobCat 10y ago
    By selling it for $10, of course.
  - user5994461 10y ago
    Simple: Add $2 for shipping. Profit from the inflated shipping free.
  - gohrt 10y ago
    With a patent on a formulation and delivery method. Most patented drugs sell at huge multiples of production cost.
    - tomp 10y ago
      I doubt this would work very well in this case, given that it's supposed to be a once-in-10-years procedure... Most pharma companies are increasingly focusing in drugs for long-term management of chronic conditions (e.g. cancer) - keep people alive and consuming your highly expensive drug covered by their insurance is incredibly lucrative.
    - smallnamespace 10y ago
      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.
  - nylonstrung 10y ago
    >Because how are pharmaceutical companies going to make billions from selling $0.10 of chemicals? How much do you think the raw inputs for Cialis are? Gross margins at the aggregate level are around 80% for this stuff. If they are practicing value based costing they could simply just undercut surgical vasectomies slightly- I'm sure every man out there would choose an outpatient injection that is reversible vs a surgical operation. I'm eagerly awaiting it getting to the market but don't buy that as an explanation
- Eric_WVGG 10y ago
  Bimek is another promising nonhormonal male contraceptive. It is literally an implanted valve controlled by a switch. http://arstechnica.com/science/2016/01/sperm-off-switch-may-offer-men-reversible-contraceptive/ http://arstechnica.com/science/2016/01/sperm-off-switch-may-... of course the health industry is bored by non-ingestible medical solutions as they don't conform to subscription pricing
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ThrustVectoring 10y ago
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 10y ago
  Also the word complain in the title should be report the whole point of a study is to identify side effects.
artofcode 10y ago
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.
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cperciva 10y ago
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.
- cjbprime 10y ago
  > 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.
  - nothrabannosir 10y ago
    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. http://www.worldlifeexpectancy.com/usa-cause-of-death-by-age-and-gender http://www.worldlifeexpectancy.com/usa-cause-of-death-by-age...
    - cjbprime 10y ago
      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.
StefanKarpinski 10y ago
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-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu...
- cup 10y ago
  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 10y ago
    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 10y ago
      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.
ropiku 10y ago
Vox has more info on this: http://www.vox.com/2016/11/2/13494126/male-birth-control-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu... The study was terminated after serious safety concerns. Over half of participants reported adverse effects.
jjcm 10y ago
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/
- chiefalchemist 10y ago
  So basically it's a horribly flaw experiment with little practical insight to be drawn from the results, or the lack there of.
- rubber_duck 10y ago
  >It's an up front dose of 1000mg of testosterone I've been reading about steroids and from what I understand different esters have different half life/release. Still every side effect described is usually associated with testosterone. As for aggression, from what I've seen there is no direct relation in most cases but it can affect some (just like not everyone gets acne or hair loss, etc)
  - leakybit 10y ago
    I have a lack of faith in the pharmaceutical industry if this is their best attempt at male birth control. Those side effects aren't from testosterone, they're from massive hormone fluctuations, which with 1000mg of testosterone every 8 weeks your gonna get. There's no ester that will increase the half-life by that much, most people get prescribed testosterone cypionate, which is considered a long ester, and it's half-life is only 8 days. The 1000mg every 8 weeks is pretty much for marketing and sales, because having to get an injection every 2 months is already a turn off for their consumer base let alone get an injection more frequent than that.
- atomical 10y ago
  "There is evidence that testosterone levels are higher in individuals with aggressive behavior, such as prisoners who have committed violent crimes."[1] There are a lot of confounding variables when you're looking at a prison population. I'm still not sure if you're serious with your comment about decreasing women's rights or if this is possibly the greatest troll comment in history.
Sukotto 10y ago
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
smoyer 10y ago
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.
- cloudjacker 10y ago
  yeah but this is for more anonymous sex, not partners that actually talk to each other
- wyager 10y ago
  It's not about reluctantly assuming responsibility; it's about having sexual autonomy.
- gohrt 10y ago
  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 10y ago
    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 10y ago
      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.
nothrabannosir 10y ago
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 10y ago
  I read it as "health risks"... because of the context of the paragraph
  - nothrabannosir 10y ago
    That must be it. You're right. Thankfully :) my mistake.
  - sundvor 10y ago
    So mental health isn't health, then? I beg to differ, so the paragraph still doesn't compute.
  - inimino 10y ago
    What does "but these are healthy men" have to do with it? That paragraph is just poorly worded.
    - mattkrause 10y ago
      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.
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tcj_phx 10y ago
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 10y ago
  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 10y ago
    > 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-system/ https://trakfertility.com/shop/trak-male-fertility-testing-s... (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 10y ago
      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 ?
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ioquatix 10y ago
> 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 10y ago
  It's also stupid given that men are on the hook for child support in the event of an accidental pregnancy.
steveplace 10y ago
They injected test without an AI to control the side effects.
- mrlase 10y ago
  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 10y ago
    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 10y ago
      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.
macey 10y ago
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 10y ago
  > 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.
cauterized 10y ago
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 10y ago
  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.
  - cauterized 10y ago
    Thank you for your enlightening perspective.
  - kingad 10y ago
    Okay, you are advocating for hardcore feminism that would change the society perceptions and make it feasible to alter behaviours. It will take time to happen but it is worth fighting for it now.
  - user5994461 10y ago
    Most women only take birth control when they're in an active relationship. Men seem to ignore that.
benmw333 10y ago
In this day in age of PC, you'd think NPR would pick a less offensive title for this article. It screams feminism.
eveningcoffee 10y ago
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.
stomato 10y ago
Ow
seanwilson 10y ago
>
- girvo 10y ago
  I believe there were two suicide attempts, one successful?
gigatexal 10y ago
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".
Pxtl 10y ago
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 10y ago
  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 10y ago
    Yes, but a suicide an infertility in a sample of 300? In a 1-year trial? It's a matter of degrees.
DRMacIver 10y ago
This piece by Dr Jen Gunter provides some better perspective on this study I think: https://drjengunter.wordpress.com/2016/11/01/new-study-doesnt-show-men-are-wimps-about-contraception-side-effects-low-vasectomy-rate-might/ https://drjengunter.wordpress.com/2016/11/01/new-study-doesn... 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.
known 10y ago
https://en.wikipedia.org/wiki/Condom https://en.wikipedia.org/wiki/Condom have no side effects
- antihero 10y ago
  Problem solved then!
kzisme 10y ago
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.

160 points by happy-go-lucky 10y ago

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/vasalgel-faqs/ https://www.parsemusfoundation.org/projects/vasalgel/vasalge...

nothrabannosir 10y ago
I keep wondering when a reputable source is going to finally cover this and somehow burst the bubble. It sounds too good to be true, yet, somehow, nobody outside their own mailing list seems to acknowledge it. What gives? Is this known quackery? I am weary to get excited, lest I get my dreams crushed yet again :/
- L_Rahman 10y ago
  One theory for why it isn't acknowledged could be that the creators and trial participants are outside of the Western cultural establishment. The material was discovered and synthesized in India at IIT by a Indian person. The largest clinical trial on Vasalgel - also in India. Media coverage doesn't happen organically. In almost all cases it is a two way street, with networks and personal contacts creating the bridge. The researchers in India and the cultural epicenters of the Western media establishment are about as distant as two nodes can be. Discovery and contact between the two parties is probably very hard. On the other hand if they tied it to a pre-dominant narrative in Western media about India - increasing sexual freedoms or a pathway to population management - and worked with the non-profit institutions that connect back to the nodes of cultural influence in the Western world, they would probably get a decent of amount of earned media coverage.
  - xenadu02 10y ago
    Eh there are reps from the big multinational pharmaceutical companies trolling all over the world for potential drugs, both man-made and natural. Lack of media coverage doesn't mean no one is paying attention.
    - duaneb 10y ago
      If they can't patent it, and it's known to be cheap, it's a race to the bottom in terms of profits. A pill would be far more profitable. I don't think pharmaceuticals would be eager for anyone to find out about it if they can't control the money.
      - kyrra 10y ago
        You still have to pay for clinical trials in the US. If the drug can't be patented then no pharma group will pay for the trials if a generic can come along once trials complete and make just as much money.
- bb611 10y ago
  It's not, but it's far from proven technology. Additionally, it's the exact opposite of most medical research - fairly inexpensive to develop (a few millions USD total), but also with very little profit upside on the other end.
  - lucaspiller 10y ago
    I wonder how many other potential medical treatments fall into this category. If a treatment was found that cured a large percentage of cancers, but was 'too cheap' to develop, would the same thing happen?
    - sleepychu 10y ago
      I think cancer would be a special case. Just because being the ones who came up with a cancer cure would be worth the small investment. Of course the criteria are likely to preclude a cancer treatment!
- alanh 10y ago
  Valerie Tarico has written about it, and she has her head screwed on straight (which I think means she’s reputable)! She's an excellent writer. However, maybe BuzzFeed needs to do a listicle on Vasalgel, or Cosmo needs to put it in SnapChat, before awareness goes mainstream… that's a sobering thought!
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carsongross 10y ago
If it eventually comes out that this works, the medical establishment and the press in the West have a huge amount of social damage to answer for.
- cheiVia0 10y ago
  Don't worry, they'll just run a story about a guy who used it and his junk fell off.
StanislavPetrov 10y ago
>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?
- BobCat 10y ago
  By selling it for $10, of course.
- user5994461 10y ago
  Simple: Add $2 for shipping. Profit from the inflated shipping free.
- gohrt 10y ago
  With a patent on a formulation and delivery method. Most patented drugs sell at huge multiples of production cost.
  - tomp 10y ago
    I doubt this would work very well in this case, given that it's supposed to be a once-in-10-years procedure... Most pharma companies are increasingly focusing in drugs for long-term management of chronic conditions (e.g. cancer) - keep people alive and consuming your highly expensive drug covered by their insurance is incredibly lucrative.
  - smallnamespace 10y ago
    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.
- nylonstrung 10y ago
  >Because how are pharmaceutical companies going to make billions from selling $0.10 of chemicals? How much do you think the raw inputs for Cialis are? Gross margins at the aggregate level are around 80% for this stuff. If they are practicing value based costing they could simply just undercut surgical vasectomies slightly- I'm sure every man out there would choose an outpatient injection that is reversible vs a surgical operation. I'm eagerly awaiting it getting to the market but don't buy that as an explanation
Eric_WVGG 10y ago
Bimek is another promising nonhormonal male contraceptive. It is literally an implanted valve controlled by a switch. http://arstechnica.com/science/2016/01/sperm-off-switch-may-offer-men-reversible-contraceptive/ http://arstechnica.com/science/2016/01/sperm-off-switch-may-... of course the health industry is bored by non-ingestible medical solutions as they don't conform to subscription pricing

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ThrustVectoring 10y ago

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 10y ago
Also the word complain in the title should be report the whole point of a study is to identify side effects.

artofcode 10y ago

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.

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cperciva 10y ago

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.

cjbprime 10y ago
> 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.
- nothrabannosir 10y ago
  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. http://www.worldlifeexpectancy.com/usa-cause-of-death-by-age-and-gender http://www.worldlifeexpectancy.com/usa-cause-of-death-by-age...
  - cjbprime 10y ago
    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.

StefanKarpinski 10y ago

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-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu...

cup 10y ago
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 10y ago
  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 10y ago
    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.

ropiku 10y ago

Vox has more info on this: http://www.vox.com/2016/11/2/13494126/male-birth-control-study http://www.vox.com/2016/11/2/13494126/male-birth-control-stu... The study was terminated after serious safety concerns. Over half of participants reported adverse effects.

jjcm 10y ago

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/

chiefalchemist 10y ago
So basically it's a horribly flaw experiment with little practical insight to be drawn from the results, or the lack there of.
rubber_duck 10y ago
>It's an up front dose of 1000mg of testosterone I've been reading about steroids and from what I understand different esters have different half life/release. Still every side effect described is usually associated with testosterone. As for aggression, from what I've seen there is no direct relation in most cases but it can affect some (just like not everyone gets acne or hair loss, etc)
- leakybit 10y ago
  I have a lack of faith in the pharmaceutical industry if this is their best attempt at male birth control. Those side effects aren't from testosterone, they're from massive hormone fluctuations, which with 1000mg of testosterone every 8 weeks your gonna get. There's no ester that will increase the half-life by that much, most people get prescribed testosterone cypionate, which is considered a long ester, and it's half-life is only 8 days. The 1000mg every 8 weeks is pretty much for marketing and sales, because having to get an injection every 2 months is already a turn off for their consumer base let alone get an injection more frequent than that.
atomical 10y ago
"There is evidence that testosterone levels are higher in individuals with aggressive behavior, such as prisoners who have committed violent crimes."[1] There are a lot of confounding variables when you're looking at a prison population. I'm still not sure if you're serious with your comment about decreasing women's rights or if this is possibly the greatest troll comment in history.

Sukotto 10y ago

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

smoyer 10y ago

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.

cloudjacker 10y ago
yeah but this is for more anonymous sex, not partners that actually talk to each other
wyager 10y ago
It's not about reluctantly assuming responsibility; it's about having sexual autonomy.
gohrt 10y ago
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 10y ago
  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 10y ago
    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.

nothrabannosir 10y ago

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 10y ago
I read it as "health risks"... because of the context of the paragraph
- nothrabannosir 10y ago
  That must be it. You're right. Thankfully :) my mistake.
- sundvor 10y ago
  So mental health isn't health, then? I beg to differ, so the paragraph still doesn't compute.
- inimino 10y ago
  What does "but these are healthy men" have to do with it? That paragraph is just poorly worded.
  - mattkrause 10y ago
    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.

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tcj_phx 10y ago

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 10y ago
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 10y ago
  > 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-system/ https://trakfertility.com/shop/trak-male-fertility-testing-s... (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 10y ago
    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 ?

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ioquatix 10y ago

> 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 10y ago
It's also stupid given that men are on the hook for child support in the event of an accidental pregnancy.

steveplace 10y ago

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

mrlase 10y ago
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 10y ago
  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 10y ago
    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.

macey 10y ago

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 10y ago
> 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.

cauterized 10y ago

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 10y ago
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.
- cauterized 10y ago
  Thank you for your enlightening perspective.
- kingad 10y ago
  Okay, you are advocating for hardcore feminism that would change the society perceptions and make it feasible to alter behaviours. It will take time to happen but it is worth fighting for it now.
- user5994461 10y ago
  Most women only take birth control when they're in an active relationship. Men seem to ignore that.

benmw333 10y ago

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

eveningcoffee 10y ago

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.

stomato 10y ago

seanwilson 10y ago

girvo 10y ago
I believe there were two suicide attempts, one successful?

gigatexal 10y ago

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".

Pxtl 10y ago

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 10y ago
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 10y ago
  Yes, but a suicide an infertility in a sample of 300? In a 1-year trial? It's a matter of degrees.

DRMacIver 10y ago

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

known 10y ago

https://en.wikipedia.org/wiki/Condom https://en.wikipedia.org/wiki/Condom have no side effects

antihero 10y ago
Problem solved then!

kzisme 10y ago

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.