Except that men as a group did not decide to shut the study down. 93.75% of the men in the study stayed in the study regardless of the side effects. The number of women who stop taking the pill due to side effects is probably higher than that.
What this shows as has already been pointed out is how crazy risk averse people who do drug development are. The reason this was stopped was because of a fear of lawsuits not whiny subjects.
My thoughts on this will say much more about me and my piss-poor judgment with regard to choosing partners, but here goes anyway.
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I can’t remember if I have ever dated anyone who took even half the responsibility for BC within the relationship. (ETA: I remembered one guy as I wrote this.) Nobody went to appointments with me. Nobody paid half. Nobody put up with side effects from whatever method was chosen except for me. If I complained about the cost, or the side effects, or having to deal with all that shit alone, all the damn time, I’d just be dismissed as whiny and “emotional.” I remember fighting hard with a long-term boyfriend (who was much wealthier than I was) after I asked him to pay for HALF the cost of the pills and maybe give me a ride to the clinic for the annual exam. I was in college at the time, so pills from the student health clinic were dirt cheap for me. I was also paying my own way through college (whereas he had parents footing all his bills and giving him spending money) so that $48 a year really was a hardship for me. And all I was asking was $2 a month plus a ride once a fucking year. And he REFUSED to do any of it. Would not take any responsibility at all; to him, it was just no big deal, so it all fell to me. Every time someone mentions a male BC pill, I think of that guy and just roll my eyes. But I should choose better men who would make good partners, so that’s really on me. The one time I did choose a good partner, HE was the one who bore the expense and responsibility – we used condoms 100%.
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Most of this thread seems to be assuming emotionally healthy, functional, loving, caring, committed partnerships. But if the BC fails and the woman does not consider abortion to be an option, she cannot opt out of the pregnancy. Any man can, regardless of who took the pills that failed. The reason we have such a thing as single moms is because many men choose to walk away from their responsibility toward their children. Even if the men were never married to their baby-mama, they still have a responsibility to any child they created. And yet so many have nothing whatsoever to do with their children.
So, while I do understand that there are tens of millions of decent men out there who are willing to take responsibility for their reproductive health and who care about their partners, in my experience (and those of my dysfunctional, fucked up family members) the men go to work and come home and the women go to work and then come home and go to work some more. That’s just the culture I was raised in – I watched my sister and stepsisters all become “married single moms” where they had partners but still were responsible for 100% of the child raising and running and care of the household. I do realize that #NotAllMen and all that and many of you right here in this thread are the exact opposite of what I’ve just described. Like I said, my opinions are informed by my own less-than-ideal upbringing and personal experiences. YMMV and all that. But I do think a lot of couples fit my dysfunctional profile and perhaps that’s where much of the negative comments on social media are coming from.
Birth control success (or failure) is per year, not per month.
You are right Memnon, those comments are incredibly sexist and offensive.
As is the assumption that women should be by themselves responsible for birth control.
I think one lesson we can definitely learn from this is that fucking with our hormones sucks, whether we are men or women. I have hormonal issues without birth control (PMDD, endometriosis) so I have to take it to function. The side effects can be terrible. I’ve tried the following birth control methods, with either no success or initial success that eventually failed: ortho tri-cyclen, Yaz, Depo, The ring, and the Mirena IUD (those are the ones I remember.) I’m currently on a monophasic that works less and less better with every passing day. I have experienced severe cramping, diarrhea, suicidal depression, anxiety, irritability, acne, etc. etc. I suspect I’m going to eventually have endometrial ablation to hold off for the next few years, and maybe then I’ll get the rubber stamp for a hysterectomy.
Birth control sucks. It just sucks. Whether this particular male contraceptive is effective enough to justify the side-effects is an important question. But the deeper, underlying question is: Why should women have to bear the entire burden?
There’s no good answer for this.
96% still seems pretty poor. What is the failure rate of the Pill?
Higher than that.
Far more than 20 men reported complications or side effects, it was just 20 who dropped out.
None of the “Women have these side effects, men are so weak!” clickbait articles I’ve seen on it made any attempt to compare the rate each incidence for each side effect. If (to make up numbers) 1-in-50 women suffer from a side effect and 1-in-10 men suffer from that effect, then saying “But women suffer from it too!” is pretty dumb, right?
I’m disappointed at how many media sources from the “open thinking” side of the street go on about how we need to destigmatize depression and be more open about mental health issues. Until you get a chance to say “Men dropped out because of depression LOL so weak baby men can’t handle it! Boo-hoo, go cry to mommy!” that is. Anything for the clicks and Facebook shares.
I think I saw one article (US News & World Report) which made the bold decision of actually saying “Hey, maybe this indicates that physicians should take greater care to explain potential effects to women” rather than going for the obvious “men can’t handle it” angle.
Any unfavorable changes in the subject’s health. Bed rest and additional medication would almost certainly be considered AEs and hospitalization is often an SAE which requires notifying the relevant IRB within 24 hours.
It is pretty disgusting.
No more than what I’ve read about it in the news and here in this thread, but my analysis lines up with millions of other people’s so I’m going to assume that my understanding isn’t very far off. Twenty guys dropped out of a study because they experienced mood changes and acne, and that’s their choice and I’m not judging them. If there were other extreme side effects documented I’d love to see a cite, but so far nothing I’ve read indicates that.
I’m not questioning the integrity of all men, I’m questioning the attitude that men shouldn’t have to suffer side effects that are assumed acceptable for women. That isn’t the individual men’s fault and I don’t think it’s a character flaw for them to decide the drug wasn’t for them, but rather that it was sexist and short-sighted for the company to end the trial because twenty people dropped out of one single study. And they didn’t drop out over very serious side effects like uncontrolled weight gain or crippling suicidal depression, they dropped out over mood swings and acne.
So to summarize, A) there’s nothing wrong with dropping out of a drug trial over those things if you feel it’s not for you however B) the side effects being reported were milder than what many women face with birth control that’s been on the market for decades, and losing twenty people from one study is not a good reason to end the trial. That’s what makes it misogynistic to me, not the fact that there are men who don’t want to put up with acne but that the company thinks they shouldn’t have to when they produce drugs for women that do the same thing.
Plus, there are men who are willing and eager to take responsibility for birth control, and now they won’t be given the opportunity.
The challenge with issues like this is separating those who have legitimate criticisms of social attitudes about gender and birth control from those who are misandrist assholes.
Keep in mind that Spice Weasel’s cite is comparing typical use, which includes incorrect and inconsistent use, to clinical trial results, which are likely to be as good as it gets. So the typical (aka real life) failure rate for a male BC shot would likely increase.
BUT, that’s really not so bad if you change the way people think about BC so that the default is that both the man and woman are responsible with the result being a combined effort and level of protection. I’m not up to speed on how schools and universities are going about their pregnancy/STD prevention these days, but it seems like focusing on the risk of failure by only relying on women’s BC would be a key piece of marketing if/when a male version becomes available.
But what women are saying is “gee, you weren’t all that concerned about risk when you were past the point of testing IUDs on us. Or the pill on us.” Where was the good testing on hormone therapy for menopause before hundreds of thousands of women got cancer?
It feels like they are more risk adverse with certain populations…
That crossed my mind as well but I’m not sure how the clinical rates would compare. Generally the less something relies upon human error, the higher its effectiveness. So the pill is the worst because you have to take it every day, but something like an IUD is a set it and forget it with a much lower rate of failure. Shots are somewhere in between because you have to remember to get the shot on time.
My husband and I used condoms and BC for many years of our marriage and even doctors acted like we were crazy. Like seriously, BC fails. It fails all the time. If you look at the odds of getting pregnant after using BC for say, five years, the odds are startlingly high.
Yeah, I was wondering how this male shot would be administered, especially after reading that the men in the study were given it once a week. That does not seem sustainable in a real life setting if you’re having to get it at a clinic, let alone if it would be self-administered. :eek:
I’m betting the nearly 50% increased acne rate makes it non marketable. And my guess is that was why they pulled it. But the only life threatening thing on that list is the 2 cases of severe depression. Severe injection pain - I’m not buying it when compared to an IUD insertion (I cramp up like a son of a bitch - like I can’t walk.) Severe irratibility - yeah, I remember a version of the pill that turned me into psycho bitch - we switched formulas.
In my experience with both the Pill and antidepressants - time has given us different options - what causes psycho bitch in me might be the perfect thing for you. What causes my libido to plummet might not effect yours at all. What makes you eat like its Fat Tuesday might not impact my appetite at all. Heck, I had one antidepressant that caused internal bleeding - we switched.
What those side effect numbers read to me is “this isn’t for every guy - you may get acne badly enough to make it not worth it.” But as they develop other male BC options, there will be options that work for more and more men. Giving up because this one doesn’t work for everyone is the drug companies assuming men will be too whiny - probably because they have enough market research to know that a mild case of acne is too much to make the formula successful. And if that is the case, we are back to “hey, girlfriend, you take the risks of an embolism, I don’t want to ruin my complexion.”
(By the way, here are the side effects for Ortho Novum:
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS Section).
Thrombophlebitis and venous thrombosis with or without embolism
Arterial thromboembolism
Pulmonary embolism
Myocardial infarction
Cerebral hemorrhage
Cerebral thrombosis
Hypertension
Gallbladder disease
Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives:
Mesenteric thrombosis
Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
Nausea
Vomiting
Gastrointestinal symptoms (such as abdominal cramps and bloating)
Breakthrough bleeding
Spotting
Change in menstrual flow
Amenorrhea
Temporary infertility after discontinuation of treatment
Edema
Melasma which may persist
Breast changes: tenderness, enlargement, secretion
Change in weight (increase or decrease)
Change in cervical erosion and secretion
Diminution in lactation when given immediately postpartum
Cholestatic jaundice
Migraine
Rash (allergic)
Mental depression
Reduced tolerance to carbohydrates
Vaginal candidiasis
Change in corneal curvature (steepening)
Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
Pre-menstrual syndrome
Cataracts
Changes in appetite
Cystitis-like syndrome
Headache
Nervousness
Dizziness
Hirsutism
Loss of scalp hair
Erythema multiforme
Erythema nodosum
Hemorrhagic eruption
Vaginitis
Porphyria
Impaired renal function
Hemolytic uremic syndrome
Acne
Changes in libido
Colitis
Budd-Chiari Syndrome)
Re: Pain at the injection site.
I was on Depo Provera for ten years. Every time I got the shot, that entire quadrant of my body ached for about three days.
Acknowledged that a single data point does not a trend make. Just saying, that’s another one of those side effects that seem perfectly acceptable for something marketed to women.
IANAD
There seems to be an excluded middle in this discussion. To level set a bit, what we are primarily talking about here is hormonal birth control. There are currently no hormonal birth control choices for males. That does not mean that birth control should fall primarily only on the woman. There are a dozen or so methods of non-hormonal birth control. Used individually, none equal 96% effectiveness butin combination the efficacy can be very high ( a math site, to be sure, but I can’t find any ‘real life’ studies on combining BC methods):
Combining the male condom with the pill, an IUD or a spermicide not only makes for very effective birth control, but also shares the responsibility. Partner won’t go for that option? I, for one, wouldn’t be having sex at all with anyone who wouldn’t cooperate on the BC issue. YMAFSMV (Your Mileage And Family Size May Vary)
Ninja’d a bit by Spice Weasel, but that’s not a bad thing.
I have been married to an awesome guy for twenty some years. Our youngest is seventeen.
When I was pregnant with her, my husband and I decided that he should get a vasectomy. We didn’t want more children. I’d been on the pill for fifteen years at that point and it wasn’t awesome for me ever - I’m susceptible to headaches and depression and the pill made both those things worse. Plus, the birth control had fallen to me for most of my sex life - sometimes the guy had condoms. The fertility treatments had fallen to me - including giving myself a shot regularly which really made me psycho bitch. The pregnancy had fallen to me. The breast feeding. And I was kind of done - he could make an appointment and spent 48 hours with a bag of frozen peas in his lap - and he agreed it was fair.
And he put off the appointment, and put it off. He put it off enough that I was done breastfeeding and went in to get a new pill prescription (I’d been off it for years - see fertility treatments - we had a surprise pregnancy long after the fertility treatments ended) and started taking the pill again. And one day I was done. He’d had a year to get snipped and hadn’t bothered - but I had managed to get into the doctor and get a new prescription so WE could have a sex life and have two little kids at home, and work a full time job, and yet still run to Target once a month to pick up the damn prescription and remember to take it every single day, even when two little kids meant I was working on four hours of sleep. So I stopped picking up the prescription and told him it was his problem - and that I was done with sex until he got his problem taken care of.
I’m sure there are men who are really really thoughtful on this topic. But my wonderful and normally thoughtful husband needed a smack upside the head to get it.
From reading the article I have to say the question isn’t men are babies for not wanting an injection, rather should women be taking the pill at all. You’ve listed a large number of potentially severe or even deadly side effects of the pill and I have to think if it were facing FDA approval today that it would have a hard time of it.
One major side effect of this injection which doesn’t seem to be paralleled in the female pill is the cool down period if you do want children. Needing to wait on average half a year and in some cases longer than a year or even a seemingly indefinite period for one participant is something that no female contraception that I am aware of has a problem with which generally allows pregnancy as soon as it is stopped being used. This is of particular importance considering the lower fertility rates women are now facing due to waiting well into their 30s before they start having babies. Not that falling female fertility rates are a consideration for cancelling the drug but it is something to think about.