Help me out here, what am I missing in this contraception controversy?

In My Humble Opinion
21

We need to find hard statistics on the prevalence of depression as a side effect for The Pill. The wiki page references a Danish study which found that 2.1% of women on the pill experienced significant depression, compared to 1.7% in the non-pill control group – a difference of only 0.4%, radically smaller than the 10% found in the male study.

Also, keep in mind that when drug companies weigh the cost/benefit ratio, the only thing they are concerned about is (1) how much money will this drug make? vs. (2) how likely is it we’ll get sued? Thanks to high-profile disasters like Vioxx and Fen-Phen, medical trials are held to far more stringent standards these days, not just by the government but by the drug companies themselves.

Men are delicate little snowflakes. You can’t blame the drug companies for that.

22

Also, doctors do think of couples as a unit at times. If you develop asthma, your spouse gets a lecture to smoke outside or quit. If one of you has herpes, the doctor makes sure you know the timeline for outbreaks could mean you got it before you were a couple, but also counsels you as a couple on managing it-- medications to prevent outbreaks, to prevent transmission, what makes transmission likely or unlikely, what you can and can’t do during an outbreak (I don’t have herpes, but I once consulted on making this talk accessible to a couple where she was mildly retarded, with good common sense, and he was moderately autistic, and bright; and they wanted to get married).

Anyway, pregnancy prevention is complicated, and the more options the better. This would be one more tool, and a welcome one. If my husband tried it, and had no side effects, great. I would probably ask him to use condoms for the three days or so when I’m ovulating, like I do now when I use the diaphragm, because we are very, uh…compatible, genetically. We got pregnant the first weekend we tried. If he got unacceptable side effects, we go back to the diaphragm, no sweat.

23

As a factual matter, does anyone know of the severity of the side effects that were observed during this study? All I’ve read is the frequency of the side effects.

Not to be flippant, but if hormonal birth control causes mild to moderate depression in x% of women, but this drug caused suicidal rampages in y% of men, I can see a case where this new drug could be considered unsafe even if y is less than x.

I’ve also heard that some common drugs approved long ago would probably not meet safety standards today. I don’t know this for a fact, but I have heard that aspirin would probably have a hard time getting FDA approval today. I wonder whether the fact that, say, estradiol was approved 60 years ago or whatever, is relevant to the fact that it remains widely available despite our better understanding today of its health risks.

24

Well, 96% success is abject failure, resulting in pregnancy one month out of 25. Or a family with ten kids during child-bearing years. Count me out.

25

Reading a different article on SFGate, I found this quote:

  • It was working until 20 men claimed of issues and the study was halted.
    From the study: “Of these 20, 6 men discontinued only for changes in mood and 6 men discontinued for the following single reasons: acne, pain or panic at first injections, palpitations, hypertension, and erectile dysfunction.” The other eight men dropped out because of mood changes.*

So basically it something as vague as ‘mood changes’ and the other reasons sound like it was one weird symptom per person which may have been psychosomatic. But there’s no evidence I can find of severe depression, or any side effects as serious as those found in female hormonal birth control.

26

This is true. Aspirin causes stomach lesions in rats, which means it probably never would have passed beyond animal testing if it were developed today.

Another important thing to remember is that drug testing is a very, very, very, very expensive process. By the time a medication reaches human trials, the drug company will have already spent millions of dollars on research & development. The only reason they would cancel a drug’s development at this stage is if it’s patently unsafe or otherwise non-marketable.

This is what makes the accusations of misogyny so silly. No drug company in the world would throw away that much money merely because they believe a woman’s place is barefoot & pregnant in the kitchen.

27

Then why would they throw it away because 20 guys dropped out of one trial?

28

Before this turns into a “bash men” thread with contributions from the usual suspects many of whom are already here (missed you guys!) perhaps an actual medical professional might care to put the study into perspective. (A doctor ideally).If 10% of men in a study experience side effects how does that correlate to

29

That sort of thing is pretty normal for clinical trials of a new drug. Jumping to the absurd conclusion that this thing was shut down because men are whiny bastards is bullshit sexism.

30

Except that there are tons of drugs that were approved that had similar side effects. Ending development because twenty people dropped out of one study over side effects that are allowed in other drugs is highly questionable.

31

Whats your medical expertise again? And knowledge of this trial?

32

I would imagine the effects were severe and it was the right call to end the study.

I also think that most of these comments are just frustrated that we are expected to automatically take this often unpleasant medication, and we don’t get a lot of acknowledgement of or gratitude for taking on this burden.

33

raises hand, cautiously I worked for six years in pharmaceutical research, on the drug trial side. . Some high level industry guidance first. I’ll get to the paper the researchers published in just a wee minute.

  1. Would 96% prevention be considered acceptable in the long run? If this is an early enough phase trial, it might be considered acceptable enough to run further trials. It does sound less than ideal for a solution a company would take to market. This is University study, so I would think it would be promising enough to pursue.

  2. How many of the side effects were minor versus severe? In general terms in research trials, everything is tracked, related or not. Minor examples might be - headache, acne, mild mood changes, colds vivid dreams. Severe - suicidal thoughts, heart attack or stroke and so on.

  3. Were the side effects so bothersome that the subjects stopped taking the drug? If they won’t take it, it may not matter if it’s a wonder drug. It doesn’t really matter whether outside observers would have the same experience if they took the drug, or thinks that someone should have toughed it out. If you read the medical literature you get with your prescriptions, you’ll often find a sentence or two in the area where they talk about side effects that says something to the effect of, “most patients were not bothered enough by these side effects to stop taking this medication.” (Or X% of patients were bothered enough by…) It is something that is tracked.

  4. A company (and the FDA, or other regulatory body) then weighs all of these points (and mounds of safety and efficacy data) against the “importance” of the medical condition being addressed. For example, pregnancy can be prevented other ways. The threshold may well be lower in terms of when to pull the plug. Cancer OTOH causes death, and some kinds have few effective treatments. Nasty side effects are commonly expected and accepted by patients, because the alternative is worse.

IOW, the FDA may well allow side effects in some drugs that they will not allow in others. Drug companies may consider the amount of drop out too high to continue.

Now, looking at this study Cite, there are some interesting things. They’ve found a method that lowers sperm count and is reversible. This is actually a large step forward. They had 320 participants, which is a large study. It was planned to run for close to 2 years. 20 participants left early, but that is not why the study was ended. The study was actually terminated early because the University Safety Review Board reviewed the Adverse Event data (side effects I mentioned earlier) and determined it was in the subjects’ best interest to stop the study. Their primary concerns were:

There is a large table in the report if anyone really wants to dig through it. Table 2. Looking at it, there were a total of 8 severe Adverse Events (1 acne, 1 injection site pain, 3 libido increased, 2 depression, 1 irritability). Consider 320 men getting shots weekly for about 18 months, that’s not bad. The numbers in moderate adverse events are higher, but follow roughly the same categories. Under mild, we see big jumps in the numbers for acne and increased libido. Again, though, at this point the subjects are saying these side effects are mild in this category.

Looking at what is presented, I don’t know why they pulled it. My only thought is that based on my experience University Review Boards are extremely conservative.

I strongly suspect that a drug company will start with this, tinker with the “blend”, see if they can get better results on the prevention side, and take this to trial on the “commercial” side of the industry.

Finally, I want to be clear that in clinical trials, one collects data on a lot of things. It would not be fair to characterize these men as whining or unable to deal. To the contrary, the vast majority stuck with the study, and did their job by accurately reporting their experiences. I would say the culprit is the media, who looked at the data and did not understand what they were seeing, or make any effort to report it accurately.

34

Thanks. We might actually fight ignorance for once rather than spread it, which seemed to be the case earlier in the thread.

How does one define “adverse”? Bed rest? Additional medication needed? Hospitalization or hospital visits?

35

Except for people who are in committed, monogamous relationships what is this going to change? Most women are genre savey enough to not believe a man who tells them he’s getting injections to prevent her pregnancy.

36

You don’t see what changes when men have better options for controlling their fertility?

It gives men another option for ensuring they don’t accidentally or “accidentally-on-purpose” have a baby they did not plan to have. There is less of a chance that a drunken night or a youthful bad decision will have lifelong consequences for three people.

It gives couples where the woman cannot take hormonal birth control another option. It also gives couples options to trade off or spread out the burden of controlling fertility. It also provides another line of defense for those ultra-fertile outliers who don’t get acceptable protection from ordinary birth control.

37

True, most women with critical thinking skills would not buy the “Oh, it’s cool, I’m on the shots” as a valid excuse to skip the condom on a random hookup, or even in the early stages of a relationship. Commercials for pregnancy tests often show a couple desperately hoping for that second pink line; they do not often show the terrified twenty-something sitting alone at her kitchen table, praying the answer she gets won’t affect the rest of her life. I would expect this drug to be similarly marketed to couples, but I have known a great deal of men who would happily beef up their own protection against fatherhood.

While I do not, on an intellectual level, agree with the “Ohh, poor man-baby doesn’t want side effects” comments, I can’t deny that they struck a small chord. Everybody’s heard the one about how if it was men who got pregnant, abortion would be an inalienable right. While I know plenty of men who buck the stereotype, for some women, this smacks of yet another subtle inequality that we’re expected to just deal with. I’m sure more than one woman on the Board could tell you about how the Pill caused terrible side effects for her, but her significant other belittled her suffering and tried to convince her to keep taking it for his convenience. Now we’re looking at the flip side, and it makes everyone slightly uncomfortable.

Medically, I’m sure there was something the the study that made it untenable. There was a reason it was stopped, and that reason was undoubtedly more solid than what the media is reporting. They’re getting more clicks with “Look how sensitive and cowardly men are about birth control!” than they ever would with “Medical study shows male birth control needs more work before FDA approval.”

38

Perhaps that is questionable. But it is not that which is being questioned, rather the character and integrity of apparently all men.

39

ROTFLMAO

We joke that if I were the American Indian sqaw, my first pregnancy would have been named “Ortho-Novum Don’t Work”, my second would have been named “Ortho-Novum Don’t Work, Rubber Broke” and my third would have been named “You Have Got To Be Shitting Me, I Had My Tubes Tied 10 Years Ago” I had severe enough issues with both my original pregnancies that my OB/GYN highly recommended I get my tubes tied and when the Catholic hospital he had priveleges to refused to let him tie my tubes [protestant, so the religious proscription does not apply in my case] he dumped that hospital and moved to using exclusively a non-religious hospital.

I personally no longer understand why they are hesitant to tie a woman’s tubes, they can always do the IVF hormone shot and go in and harvest eggs, it doesn’t remove the ability for the womb to be implanted and generate life … shrug I admit, I never actually wanted kids, I seem to have a lack of maternal instinct and do best with godchildren and niece/nephew/friend’s kids where I can babysit and give them back. I admit I have a well controlled short temper, and do fear that I would end up getting abusive after being subjected to several months of not sleeping and a screaming shit factory … so ‘borrowing’ a kid for a few hours at a time is good because I know that later I will be having a good night’s sleep, and calm quiet peaceful times.

mrAru and self had a conversation before we even decided to get married, he told me that if I hadn’t had a tubal, he would have volunteered to get his snip done, though through several years of experimentation did find me a pill to tame my PCOS because all the other stuff was causing me issues [I ended up halting my PCOS nastiness with norethindrone, I personally would have been good with yanking out my womb and leaving me the good ovary decades before my hysterectomy 5 years ago, which reminds me, 5 years post ovarian cancer, I LIVED!!!:p]

40

On the male hookup side - I would think plenty - if you have a way to really lower the risk of her getting pregnant “accidentally on purpose” (because women have also used ‘its ok, I’m on the pill’ - you might want to take it to avoid the later child support checks.

In an ideal world where it was available - sexual freedom would mean that there was a barrier method to reduce risk of disease transmission - the woman would take responsibility for her fertility and the man would take responsibility for his. Each method has a small chance of failure - but in combination, your risk of contraceptive failure become very low. And if one partner is lying, the risk is lower for the other partner than unprotected sex.

Women have borne the brunt of responsibility and risk when it comes to sex - and contraception. The IUD had its issues (its now very safe), the pill was not great at first release (its gotten much better with time). Then there are all the other risks unrelated to contraception - the risk things get out of hand and “fun” turns into rape is mostly bourne by women. If pregnancy occurs - women get the risk involved in pregnancy.

Sex is fun. But if guys want male female sex between two people, they should be doing what they can to pick up more of the responsibility.

Right now, sex is kind of like you and a friend buying a boat together. He rides in it every weekend, but you pays for the gas, you get the boat into the water at the start of the season and take it out at the end of the season, you do all of the maintenance and carry the insurance. This study is the slap in the face you get when you call him to say “dude, I’ll be out of town the weekend we need to pull out the boat, can you do it?” And he says “I might hurt my back, its probably best if you do it before you leave.”