Author Topic: Choice For Men?  (Read 6674 times)

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Offline Odysseus

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Choice For Men?
« on: May 27, 2012, 04:01:53 AM »
A mate of mine posted this article up on another forum.  I thought it was worth a thread here.  I'm still thinking about it as I've only just read it.  Food for thought.....

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On January 22, 1973, the United States Supreme Court eliminated a checkerboard of state laws on reproductive freedom and guaranteed American women choice throughout the country. Thirty years later, American men are still waiting for the same right.

When a woman gets pregnant she has the right to decide whether or not to carry the baby to term, and whether to raise the child herself or to give it up for adoption. In over 40 states she can even terminate all parental responsibility by returning the baby to the hospital within a few days or weeks of birth. Yet if she decides she wants the child, she can demand 18 years of child support from the father, and he has no choice in the matter. When it comes to reproduction, in America today women have rights and men merely have responsibilities.

Certainly nobody should be able to dictate to a woman what she can and cannot do with her own body, thus the feminist slogan "My Body, My Choice." Yet our current laws allow a woman to dictate to a man what to do with his body. The average American father works a 51-hour work week, one of the longest in the industrialized world. It is men, overwhelmingly, who do our society's hazardous and most strenuous jobs, and nearly 50 American workers--mostly men--are injured every minute of the 40-hour work week. Can anybody deny that the sacrifices required to pay 18 years of child support take a heavy toll on a man's body, too? Where's his choice?

Feminists are legitimately concerned that, if abortion were banned, the government would be exercising control over a very intimate and important part of a woman's life. But when a woman forces a man to be responsible for a child only she wants, and when the state child-support apparatus takes a third or more of his income and jails him if he comes up short, isn't the government exercising control over his life?

The "Choice for Men" movement seeks to give fathers the right to relinquish their parental rights and responsibilities within a month of learning of a pregnancy, just as mothers do when they choose to give their children up for adoption. These men would be obligated to provide legitimate financial compensation to cover pregnancy-related medical expenses and the mother's loss of income during pregnancy. The right would only apply to pregnancies which occurred outside of marriage, and women would still be free to exercise all of the reproductive choices they now have.

Advocates of Choice for Men note that over 1.5 million American women legally walk away from motherhood every year by either adoption, abortion, or abandonment, and demand that men, like women, be given reproductive options. They point out that, unlike women, men have no reliable contraception available to them, since the failure rate of condoms is substantial, and vasectomies are impractical for young men who plan on becoming fathers later in life.

Since there are long backlogs of stable, two-parent families looking for babies to adopt, there is no reason why any child born out of wedlock to unwilling parents would be without a good home. In addition, if women knew that they could not compel men to pay to support children they do not want, the number of unwed births (and the social problems associated with them) would be reduced.

Some of those who fought for women's reproductive choices support choice for men. Karen DeCrow, former president of the National Organization for Women, writes:

"If a woman makes a unilateral decision to bring a pregnancy to term, and the biological father does not, and cannot, share in this decision, he should not be liable for 21 years of support ... autonomous women making independent decisions about their lives should not expect men to finance their choice."

To date, courts have refused to respect men's reproductive rights even in the most extreme cases, including: when child support is demanded from men who were as young as 12 when they were statutorily raped by older women; when women have taken the semen from a used condom and inserted it in themselves, including from condoms used only in oral sex; and when a woman has concealed her pregnancy from her former partner (denying him the right to be a father) and then sued for back and current child support eight or ten years later.

The National Abortion Rights Action League (renamed "NARAL Pro-Choice America" on January 1 of this year), has been in the forefront of the struggle for choice for women for over three decades. They explain that "the essence of America is the right to determine the course of one's life, to make one's own choices and shape one's own destiny. A woman's freedom to choose is integral to that concept of liberty." Fine words, but is there one of them which does not apply equally to men? Shouldn't men have a choice, too?

http://www.glennsacks.com/30_years_after.htm

Offline BlobVanDam

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Re: Choice For Men?
« Reply #1 on: May 27, 2012, 04:12:15 AM »
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They point out that, unlike women, men have no reliable contraception available to them, since the failure rate of condoms is substantial, and vasectomies are impractical for young men who plan on becoming fathers later in life.

This stuck out big time to me. They're not perfect, but no contraceptive is, but they're reliable enough to put as much responsibility on the man as the woman for preventing pregnancy. No excuse. If you're really that worried about getting a girl pregnant, you don't do the deed. Actions have consequences.

I think there are a few good points in the article, but their reasoning and solution are simply trying to avoid all responsibility altogether, which is taking it too far imo. It's a walk away clause for people who can't accept the responsibility of their own actions.
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Offline hefdaddy42

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Re: Choice For Men?
« Reply #2 on: May 27, 2012, 04:16:51 AM »
I understand that, but it does seem unfair that the woman gets to make all the decisions and the man simply has to live with them and has no say himself.
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Re: Choice For Men?
« Reply #3 on: May 27, 2012, 04:18:56 AM »
I understand that, but it does seem unfair that the woman gets to make all the decisions and the man simply has to live with them and has no say himself.

I completely agree with that much. How do you feel about their solution posed though? What would be the best solution? I have no idea, but I'm not sure I agree with their idea.
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Offline kirksnosehair

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Re: Choice For Men?
« Reply #4 on: May 27, 2012, 06:16:25 AM »
One thing that is stated incorrectly in that piece is the fact that women can "demand 18 years of child support"

In most jurisdictions the age limit for the custodial parent to receive child support is 23 years old, provided that the child is enrolled in college.

I know this because I paid child support for my son until he turned 23 in 2010.



Offline Odysseus

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Re: Choice For Men?
« Reply #5 on: May 27, 2012, 10:26:07 AM »
I understand that, but it does seem unfair that the woman gets to make all the decisions and the man simply has to live with them and has no say himself.

I completely agree with that much. How do you feel about their solution posed though? What would be the best solution? I have no idea, but I'm not sure I agree with their idea.

I definitely agree that all the decision making rests with the woman and that needs to be remedied.  I know far too many people who've been fallen victim to unwanted pregnancies and been financially ruined as a result.  I understand the idea of 'don't do the crime if you don't want to do the time' but I can't see many blokes opting for monk-like celibacy during early courtship with a potential spouse.  It takes to decide whether that person is right for you, and one hopes that the bloke is wearing a bag and the girl is on the pill or something.  Sadly, over here in Britain, a young girl getting knocked up is a ticket to free money and work-avoidance, and many take full advantage of that option.

I guess the only real solution would be a male contraceptive pill.  I heard research was under way a few years back to develop such a pill, but I don't recall anything useful arising from it.  Maybe I'll check that out later...

Being a regular gym-goer, I understand that the steroid testosterone enanthate has the reputation of killing your glop stone dead, but I'm unsure how true that is.... not sure I'd want to get geared up for a rumour....

Offline theseoafs

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Re: Choice For Men?
« Reply #6 on: May 27, 2012, 10:30:50 AM »
I understand that, but it does seem unfair that the woman gets to make all the decisions and the man simply has to live with them and has no say himself.

I completely agree with that much. How do you feel about their solution posed though? What would be the best solution? I have no idea, but I'm not sure I agree with their idea.

I guess the only real solution would be a male contraceptive pill.

Seriously? Is the condom really so unreliable that men need this?

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Re: Choice For Men?
« Reply #7 on: May 27, 2012, 10:34:26 AM »
The typical use of male condoms, which is the average way most people use them, has a failure rate of 14-15%

The typical use pregnancy rate among condom users varies depending on the population being studied, ranging from 1018% per year.[50] The perfect use pregnancy rate of condoms is 2% per year.[48]


Certainly more unreliable than something like the pill.
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Offline Odysseus

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Re: Choice For Men?
« Reply #8 on: May 27, 2012, 10:44:01 AM »
Seriously? Is the condom really so unreliable that men need this?

It's unreliable enough to pose a problem.  Not just the manufacture, but accidents happen....

Offline BlobVanDam

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Re: Choice For Men?
« Reply #9 on: May 27, 2012, 10:54:42 AM »
The typical use of male condoms, which is the average way most people use them, has a failure rate of 14-15%

The typical use pregnancy rate among condom users varies depending on the population being studied, ranging from 1018% per year.[50] The perfect use pregnancy rate of condoms is 2% per year.[48]


Certainly more unreliable than something like the pill.

Yikes, I was thinking it was more like 5%. With these figures, that failure rate is high enough to be more of an issue here that I thought.
The way I see it, if you wore a condom, and she still gets pregnant due to a failure, you've proven that you tried to take reasonable precautions against it, and probably shouldn't have to be forced to be paying for the kid for the next 20 years or so if she keeps it. If you didn't wear a condom, then maybe you should have to take responsibility?
Maybe the need for a male contraceptive isn't as trivial as I thought.
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Offline Phoenix87x

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Re: Choice For Men?
« Reply #10 on: May 27, 2012, 02:45:22 PM »

I definitely agree that all the decision making rests with the woman and that needs to be remedied.  I know far too many people who've been fallen victim to unwanted pregnancies and been financially ruined as a result

I guess the only real solution would be a male contraceptive pill.  I heard research was under way a few years back to develop such a pill, but I don't recall anything useful arising from it.  Maybe I'll check that out later...


   I also know way too many people that have fallen victim to this and that is why I am uber careful and honestly a little paranoid when it comes down to getting intimate with someone. A friend of mine at work used a condom, but it broke. Not only did it financially ruin him, but emotionally as well since the mother won't allow him to see his daughter unless he bows down to her demands. 2 other friends at work are in the same situation, but the mother said she was on the pill, but lied.

At this point, I don't get intimate with anyone, unless I really feel like I could spend the rest of my life with that person. Its kind of strict, but its allowing me to live my life the way I want to live it.

I would be totally all for a male contraceptive pill though.
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Offline orcus116

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Re: Choice For Men?
« Reply #11 on: May 27, 2012, 02:50:34 PM »
One thing that is stated incorrectly in that piece is the fact that women can "demand 18 years of child support"

In most jurisdictions the age limit for the custodial parent to receive child support is 23 years old, provided that the child is enrolled in college.

I know this because I paid child support for my son until he turned 23 in 2010.

Is the amount for child support different per case or is there some kind of state average?

Offline Scheavo

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Re: Choice For Men?
« Reply #12 on: May 27, 2012, 02:59:06 PM »
Pretty sure they've made the male pill. Currently going through safety tests.

But, after seeing recent "Yaz" commercials about a huge medical settlement, Id be a little cautious. The FDA is fairly corrupt and inept at this point. Another solution, I saw out of Egypt was underwear which heated your balls too much to produce sperm - whitey tighties anyone?

Offline Adami

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Re: Choice For Men?
« Reply #13 on: May 27, 2012, 03:11:45 PM »
One problem with this is the scenario of a young couple getting pregnant (on purpose or by accident, doesn't matter) then when she has the baby, the guy freaks out and leaves. This really screws the woman over in every possible way. By this point her just giving up the baby is likely an emotional option that she will not and should  not have to consider. This "get out of jail free" card is a bad idea.
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Offline millahh

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Re: Choice For Men?
« Reply #14 on: May 27, 2012, 03:46:43 PM »
Pretty sure they've made the male pill. Currently going through safety tests.

But, after seeing recent "Yaz" commercials about a huge medical settlement, Id be a little cautious. The FDA is fairly corrupt and inept at this point. Another solution, I saw out of Egypt was underwear which heated your balls too much to produce sperm - whitey tighties anyone?

As I'm being put through the meat grinder by the FDA approval process at the moment, I disagree with your assessment.  Given the inherent nature of pharmaceuticals, there's always a chance of seeing a significant side-effect that affects a small enough % of the population that it isn't observed in the Phase 3 safety studies.

Anyway, the YAZ thing is two-fold:
-Bayer was making unsupported claims in ads (alleviating certain PMS symptoms, clearing up skin), and the FDA bitch-slapped them for it.  Hard.
-It would appear that Bayer was aware of the increased risk of stroke, and downplayed it to the FDA, and the FDA bitch-slapped them for it.  hard.

I've actually been in seminars where YAZ is held up as an example of "what not to do", and the FDA seems to be making an example of them.

I don't chalk this up to regulatory ineptitude, as it seems as though the FDA may not have been given all of the information.

As far as corruption, the only instances I've ever seen of that all stemmed from one reviewer buying stocks of companies for which he was reviewing a submission, and selling them immediately when the drug was approved.  I believe that guy (and his son) are now in jail for insider trading.
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Offline Scheavo

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Re: Choice For Men?
« Reply #15 on: May 27, 2012, 04:45:03 PM »
Quote
I don't chalk this up to regulatory ineptitude, as it seems as though the FDA may not have been given all of the information.

Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?

I guess I also just don't believe that the FDA isn't corrupt. Our entire system is corrupt, and I'd demand extraordinary proof to show that the FDA is somehow exempt from this.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.

Offline millahh

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Re: Choice For Men?
« Reply #16 on: May 28, 2012, 07:33:58 AM »
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I don't chalk this up to regulatory ineptitude, as it seems as though the FDA may not have been given all of the information.

Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?

I guess I also just don't believe that the FDA isn't corrupt. Our entire system is corrupt, and I'd demand extraordinary proof to show that the FDA is somehow exempt from this.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.

On corruption or lack thereof, you've put me in a "prove the negative" situation...so we're not going to get anywhere from that direction.  Do you have specific examples of corruption within the FDA, or things you suspect happen?

I am not aware of anything corrupt in what they do (aside from that insider trading thing I mentioned, and he's in jail).  There are dfinitely some power-tripping petty tyrants who get off on bullying people (there are a couple of inspectors like this), but that's not corruption, that's just being an asshole.

As far as claims that are approved vs. those that are claimed in ads (or, more frequently, by ethically-challenged salespeople), the FDA does not have the power to actually prevent such claims from being made.  However, what they do have is enforcement power if an ad or a salesperson is touting an off-label use; the penalties for transgressions can be quite high.  And even I, working in R&D, had to go through the training about this.

The FDA can only review the data that is put in front of them.  There are strict requirements around what this data should be, and if a company is found to have skirted it, there are severe penalties both from the agency and in civil lawsuits.  This applies to all relevant data...clinical, pharmacology/toxicity, chemistry/manufacturing (the last of these is my area, and where I've written stuff that has gone into them).

In a way, the FDA is a law enforcement agency...they can't always prevent a law from being broken, but they can set the penalty high enough that it deters shenanigans.

As far as settlements, many times a company will settle just to avoid a runaway jury situation...there have been vaccine settlements in the tens of millions of dollars for adverse events that could not have possibly arisen from the vaccination...but most of the populace is scietifically illiterate, loves to see big pharma as evil, and is easily manipulated by lawyers and the appearance of sick kids...whether or not the sickness could have actually arised from the vaccination.  So with that in mind, many companies, don't want to risk something going in front of a jury.

If you want to find the meaningful actions against pharma companies, look at actions by the FDA, SEC, FTC, and DoJ.
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Offline millahh

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Re: Choice For Men?
« Reply #17 on: May 28, 2012, 08:00:08 AM »
I should add that there are certainly some legitimate settlements for people who have suffered adverse events (where there was no malfeasance on the part of the company), and these are unfortunately unavoidable.  Say a given adverse event occurrs in 0.02% of the population (1 in 5000), it is unlikely to be observed in a 1000 person trial, and even if it is observed, it is quite unlikely to be observed twice (therefore, no pattern).*  In these cases, there's product liability just like with anythign else, and additionally, more warnings may be put on the box, physicians and pharmacists will use added precaution, and in some cases the drug could just go off the market altogether.  These post-marketing studies are carried out for pretty much all drugs, precisiely so that these rare side-effects can be caught.

*Even if somethign is only observed once, it is factored in, and that's even if there's no conceivable way it could be related to the treatment....for example, if someone dies of a heart attack while in a trial for a locally acting constipation medicine.
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Offline GuineaPig

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Re: Choice For Men?
« Reply #18 on: May 28, 2012, 08:08:15 AM »
Given all the other ways men have it better than women, I'm not caught up in this slight imbalance.
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Offline skydivingninja

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Re: Choice For Men?
« Reply #19 on: May 28, 2012, 08:44:46 AM »
Given all the other ways men have it better than women, I'm not caught up in this slight imbalance.

My thought throughout reading the article.  I would, however, not be opposed to ways to get out of child support in situations like the ones presented at the end of the article.  I don't think those men should not be legally responsible to be fathers under those circumstances, especially the rape victims.

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Re: Choice For Men?
« Reply #20 on: May 28, 2012, 08:59:41 AM »
One thing that is stated incorrectly in that piece is the fact that women can "demand 18 years of child support"

In most jurisdictions the age limit for the custodial parent to receive child support is 23 years old, provided that the child is enrolled in college.

I know this because I paid child support for my son until he turned 23 in 2010.

Is the amount for child support different per case or is there some kind of state average?

It varies by state.   My ex and I divorced when she was 6 months pregnant.  The marriage was a complete train wreck.  So, the kid lived in New Jersey with his mother while I lived here in Massachusetts, so it was a fairly unusual deal where the Massachusetts Department of Revenue collected the money (garnished my wages) on behalf of New Jersey.  I paid a set fee, ordered by a judge when I legally acknowledged paternity. (soon after he was born).  I paid a set amount which was periodically adjusted for inflation for 23 years.

From what I have heard about regular, straight up child support for residents of Massachusetts, the DOR can take up to 2/3 of your wages through payroll deductions (wage garnishments).

I will tell you this:  You *will not* escape paying it once you are legally designated as the non-custodial parent of the child in question.  I can only relate my experience dealing with Massachusetts and New Jersey.  They (both states, afaik) don't care if you are incapacitated in some way and unable to work, they'll just garnish your unemployment or Social Security Disability Insurance payments, or whatever they can get their hands on.  The only way to avoid it is to be paid cash, but avoidance is not wise as it just accrues when you don't pay it and eventually you are going to pay it one way or the other.  They will take your income tax refunds (state and federal), they will even go directly into your bank account and just take your money.  That's right, I wrote "take your money" straight out of your bank account.  It happened to me because of a clerical error.  One minute I had $17k in my checking account, the next minute I couldn't buy a pack of fucking chewing gum with my debit card because the DOR had made a mistake and thought I owed $20k in arrears on my child support so they got a court order and drained my bank account instantly.

It cost me $3k in attorney fees (and 9 linear weeks of time) to get the money back and no, I was not able to recover the attorney fees.  Pretty sweet, ay?  :mehlin

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Offline Phoenix87x

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Re: Choice For Men?
« Reply #22 on: May 28, 2012, 09:33:03 AM »
Relevant.

http://www.thehollywoodgossip.com/2012/05/desmond-hatchett-father-of-30-kids-seeks-reduction-in-child-supp/

So despite having 30 kids, they are still only taking half his paycheck right?  But dividing it up.

  wouldn't they still take half if he had only one kid, or is he paying some larger amount based on the number of kids?
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Offline Odysseus

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Re: Choice For Men?
« Reply #23 on: May 28, 2012, 11:11:50 AM »
One problem with this is the scenario of a young couple getting pregnant (on purpose or by accident, doesn't matter) then when she has the baby, the guy freaks out and leaves. This really screws the woman over in every possible way. By this point her just giving up the baby is likely an emotional option that she will not and should  not have to consider. This "get out of jail free" card is a bad idea.

I agree with some of what you say, but the article stipulates that the man's decision needs to be within a month of learning of the pregnancy, so it isn't really that much of a "get out of jail free" card:

Quote
The "Choice for Men" movement seeks to give fathers the right to relinquish their parental rights and responsibilities within a month of learning of a pregnancy, just as mothers do when they choose to give their children up for adoption. These men would be obligated to provide legitimate financial compensation to cover pregnancy-related medical expenses and the mother's loss of income during pregnancy. The right would only apply to pregnancies which occurred outside of marriage, and women would still be free to exercise all of the reproductive choices they now have.

I thnk that a move towards something like this would make people think a lot more seriously about whether they have children.  Being a parent is the most important job in the world and not one that should be taken lightly.  It is a responsibility, not necessarily a right.  Plus.... if women didn't think they had the legal authority to attach the man's wages, I'd be willing to bet many of them would change their views on whether they could afford to have a child...

Offline millahh

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Re: Choice For Men?
« Reply #24 on: May 28, 2012, 11:17:49 AM »
Given all the other ways men have it better than women, I'm not caught up in this slight imbalance.

This works in womens' favor...with the exception of condoms, the onus for birth control is always on the woman (pill, IUD, diaphragm, sponge, gel, etc.).  If a non-barrier method is available to men, it removes the burden from women (or distributes it more equitably).  And most women hate taking the pill...there's weight-gain, reduced sex drive, mood effects and whatnot.  My wife absolutely hates it for these reasons.

Birth control should be the responsibility of both parties, and any step towards making that equal responsibility a reality is a victory for women.
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Offline Odysseus

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Re: Choice For Men?
« Reply #25 on: May 28, 2012, 01:43:18 PM »
Given all the other ways men have it better than women, I'm not caught up in this slight imbalance.

This works in womens' favor...with the exception of condoms, the onus for birth control is always on the woman (pill, IUD, diaphragm, sponge, gel, etc.).  If a non-barrier method is available to men, it removes the burden from women (or distributes it more equitably).  And most women hate taking the pill...there's weight-gain, reduced sex drive, mood effects and whatnot.  My wife absolutely hates it for these reasons.

Birth control should be the responsibility of both parties, and any step towards making that equal responsibility a reality is a victory for women.

I agree!

It will be a victory for both sexes, but not for women who want a free lunch. 

Mind you, a male pill will open up the possibility of a man being able to claim he's trying to get his wife up the duff while he's secretly scoffing pills down to avoid the responsibility. Ahh... well at least that's probably better than an unwanted child... from his point of view anyway.  Whichever way you look at it, things are open to a certain amount of foul play...

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Re: Choice For Men?
« Reply #26 on: May 28, 2012, 02:57:56 PM »
I've spent a fair amount of time trying to shake an idea about this out of my head, and I really don't have a clue.  This one's got me completely stumped.  I agree with the OP that this is an inherently unfair situation, but I don't see a reasonable solution.  Giving men a pass on it just doesn't seem like a viable option. 
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Offline orcus116

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Re: Choice For Men?
« Reply #27 on: May 28, 2012, 03:07:47 PM »
Maybe have the woman prove that she's trying to actually support the child? Granted all situations are different and I can't really speak from experience as far as how much money a child costs but I can envision someone having the kid then sitting on their ass collecting child support while not really doing much to contribute any funds of their own past the point where you don't need to watch the kid 24/7.

Offline Scheavo

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Re: Choice For Men?
« Reply #28 on: May 28, 2012, 03:31:12 PM »
Quote
I don't chalk this up to regulatory ineptitude, as it seems as though the FDA may not have been given all of the information.

Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?

I guess I also just don't believe that the FDA isn't corrupt. Our entire system is corrupt, and I'd demand extraordinary proof to show that the FDA is somehow exempt from this.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.

On corruption or lack thereof, you've put me in a "prove the negative" situation...so we're not going to get anywhere from that direction.  Do you have specific examples of corruption within the FDA, or things you suspect happen?

I am not aware of anything corrupt in what they do (aside from that insider trading thing I mentioned, and he's in jail).  There are dfinitely some power-tripping petty tyrants who get off on bullying people (there are a couple of inspectors like this), but that's not corruption, that's just being an asshole.

As far as claims that are approved vs. those that are claimed in ads (or, more frequently, by ethically-challenged salespeople), the FDA does not have the power to actually prevent such claims from being made.  However, what they do have is enforcement power if an ad or a salesperson is touting an off-label use; the penalties for transgressions can be quite high.  And even I, working in R&D, had to go through the training about this.

The FDA can only review the data that is put in front of them.  There are strict requirements around what this data should be, and if a company is found to have skirted it, there are severe penalties both from the agency and in civil lawsuits.  This applies to all relevant data...clinical, pharmacology/toxicity, chemistry/manufacturing (the last of these is my area, and where I've written stuff that has gone into them).

In a way, the FDA is a law enforcement agency...they can't always prevent a law from being broken, but they can set the penalty high enough that it deters shenanigans.

As far as settlements, many times a company will settle just to avoid a runaway jury situation...there have been vaccine settlements in the tens of millions of dollars for adverse events that could not have possibly arisen from the vaccination...but most of the populace is scietifically illiterate, loves to see big pharma as evil, and is easily manipulated by lawyers and the appearance of sick kids...whether or not the sickness could have actually arised from the vaccination.  So with that in mind, many companies, don't want to risk something going in front of a jury.

If you want to find the meaningful actions against pharma companies, look at actions by the FDA, SEC, FTC, and DoJ.

First of all, I just wanna say this is a great post.

I think the corruption is fundamental to the way the FDA is working, the very way in which it is set up. Individuals working within the Department aren't corrupt, they're doing their job. For me, it would be like the Police Department or the FBI requesting the accused person for evidence and proof of their innocence, and at times basically just trusting it to be true. There's a very old adage not to trust those who have something to gain, and it seems to be something our entire regulatory system has either forgotten, or chooses to ignore.

I guess the above will depend upon the field. There are certainly area's where it's only possible for the FDA to sue and go after people after the problem (mostly, the "food" aspect).

Offline millahh

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Re: Choice For Men?
« Reply #29 on: May 28, 2012, 07:53:20 PM »
Quote
I don't chalk this up to regulatory ineptitude, as it seems as though the FDA may not have been given all of the information.

Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?

I guess I also just don't believe that the FDA isn't corrupt. Our entire system is corrupt, and I'd demand extraordinary proof to show that the FDA is somehow exempt from this.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.

On corruption or lack thereof, you've put me in a "prove the negative" situation...so we're not going to get anywhere from that direction.  Do you have specific examples of corruption within the FDA, or things you suspect happen?

I am not aware of anything corrupt in what they do (aside from that insider trading thing I mentioned, and he's in jail).  There are dfinitely some power-tripping petty tyrants who get off on bullying people (there are a couple of inspectors like this), but that's not corruption, that's just being an asshole.

As far as claims that are approved vs. those that are claimed in ads (or, more frequently, by ethically-challenged salespeople), the FDA does not have the power to actually prevent such claims from being made.  However, what they do have is enforcement power if an ad or a salesperson is touting an off-label use; the penalties for transgressions can be quite high.  And even I, working in R&D, had to go through the training about this.

The FDA can only review the data that is put in front of them.  There are strict requirements around what this data should be, and if a company is found to have skirted it, there are severe penalties both from the agency and in civil lawsuits.  This applies to all relevant data...clinical, pharmacology/toxicity, chemistry/manufacturing (the last of these is my area, and where I've written stuff that has gone into them).

In a way, the FDA is a law enforcement agency...they can't always prevent a law from being broken, but they can set the penalty high enough that it deters shenanigans.

As far as settlements, many times a company will settle just to avoid a runaway jury situation...there have been vaccine settlements in the tens of millions of dollars for adverse events that could not have possibly arisen from the vaccination...but most of the populace is scietifically illiterate, loves to see big pharma as evil, and is easily manipulated by lawyers and the appearance of sick kids...whether or not the sickness could have actually arised from the vaccination.  So with that in mind, many companies, don't want to risk something going in front of a jury.

If you want to find the meaningful actions against pharma companies, look at actions by the FDA, SEC, FTC, and DoJ.

First of all, I just wanna say this is a great post.

I think the corruption is fundamental to the way the FDA is working, the very way in which it is set up. Individuals working within the Department aren't corrupt, they're doing their job. For me, it would be like the Police Department or the FBI requesting the accused person for evidence and proof of their innocence, and at times basically just trusting it to be true. There's a very old adage not to trust those who have something to gain, and it seems to be something our entire regulatory system has either forgotten, or chooses to ignore.

I guess the above will depend upon the field. There are certainly area's where it's only possible for the FDA to sue and go after people after the problem (mostly, the "food" aspect).

Ok, this is where my lesser familiarity with the clinical side of things is catching up with me...I know the requirements for the chemistry stuff backwards and forwards, and there are some parallels, but not everything is the same.

Here's the deal:  For approval, the requiremements for what trials are run, their size, how they're set up, and how the data is to be reported/analyzed are all pretty standardized, and there's not really any way to hide anything, outside of outright data falsification (which would get the individuals thrown in jail, and could result in penalties so severe as to be an effective "death penalty" for the company).  I've never really heard of this type of thing happening...and there would be little to gain from doing so, as a drug that was approved under false pretenses would show it's true colors in the post-marketing studies...which could result in the drug being removed from the market, and would almost certainly cast suspicion upon the clinical data that was filed in the NDA (New Drug Application, the package that goes into the FDA for approval).  Any fraud or other shady stuff in the application would be suicidal.

The YAZ issue (and the Phen/Fen issue, and other infamous drugs), is centered around the post-marketing (i.e. phase 4) studies.  These are conducted for three different reasons: 1). to study safety/efficacy in the general population, 2). to add a new indication or 3). Evaluate the effectiveness/safety of the drug when taken in combination with another drug.  In the case of YAZ, the big problems was that there were emerging indication of the elevated stroke risk (in the first type of study), but Bayer stuck their heads in the sand (neither digging further, nor recalling the drug).  My understanding is that the risks started becoming apparent during the study, well before the data reporting stage.  They got smacked by both the FDA and the civil courts for dragging their feet.  Phen/Fen was a similar situation, except that was a study for taking two drugs in combination.

I'll never understand why a company wouldn't act quickly on discovering a legitimate problem...yes, it may mean continued profits on the drug in the short term, but with every day that passes, the liability increases, and will always outweigh any profits.

My apologies for being a bit off the marker earlier...I was going from memory, outside of my realm of expertise.
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Offline Scheavo

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Re: Choice For Men?
« Reply #30 on: May 28, 2012, 10:04:46 PM »
Well, you clearly know about this than me.

Quote
and there's not really any way to hide anything, outside of outright data falsification (which would get the individuals thrown in jail, and could result in penalties so severe as to be an effective "death penalty" for the company)

And if the trials, and the requirements, aren't good enough for some things to be caught? At what point, do we need to examine those requirements, when a drug can be released to the market, etc; and how corrupt is the process which currently determines that? Given what our Government is at this point, I'd find it extremely shocking if these requirements were truly adequate, and not at least a little corrupt.

More demands tests would mean a drug can take longer to get to the general public, but I see no reason why phase 4 studies can't be done with just larger, more random samplings. Before, ya know, it can be put in a TV ad, and where misleading statements can only be dealt with after the fact.

That also said, is there a threshold requirement before a company is held liable? There are certainly some things which would be unreasonable to expect being caught. And I think it theoretically make me want to retract everything.

*edit*

I posted that, then I re-saw the thread title, and felt that this too quickly got off track. In an attempt to get it back on track, it seems to me there are several area's in society, where women have actually gained the upper hand when compared to men. It's not in many, and there are so many other area's of life where men have it easier, so I think it needs to be kept in perspective.

Once, while watching Lockdown, they interviewed a guy there who killed his girlfriend and her family because he found out she had an abortion, and didn't tell him. He said he felt extremely hurt that she killed his son. His actions are beyond extreme, and definitely not acceptable, but it's a stereotype of men that none of them want to be father's, that they'll all run away at the first opportunity. It's true of a great deal of men, but not all men.

« Last Edit: May 28, 2012, 10:14:10 PM by Scheavo »

Offline slycordinator

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Re: Choice For Men?
« Reply #31 on: May 28, 2012, 11:41:54 PM »
Seriously? Is the condom really so unreliable that men need this?
If you check the OP, it refers to cases of men even being forced to pay for child support when he used a condom and the woman retrieved it from the trash and placed the contents inside her. So even when the thing is used successfully as it was designed, a bad situation can arise.

Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?
The problem is that for the FDA to truly do that, they'd have to redo the studies the drug companies themselves performed and see if everything matches what's being claimed. But that would require way more manpower than we have at this time and would cost a lot lot more money.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.
While you've got a point to an extent, there's a problem that payouts (in form of settlements or jury-imposed damages) don't always translate into companies doing bad things. For instance, lots of women got money for breast implants causing diseases for them when it's been shown that the diseases don't occur in any greater frequency than in the general population.

Offline Rick

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Offline ReaPsTA

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Re: Choice For Men?
« Reply #33 on: May 29, 2012, 01:35:35 PM »
http://www.newstatesman.com/blogs/lifestyle/2012/05/mens-rights-zeitgeist

Eh.  I don't see how the topic raised in the OP is necessarily comparable with what's preached by the men's rights loons.
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Offline Odysseus

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Re: Choice For Men?
« Reply #34 on: May 31, 2012, 02:22:34 PM »
Yup. You're gonna get wingnuts on each side of the gender fence - they're a good source of lulz but otherwise pointless.