Plan B available "over the counter"

[Quiet_Cool]

I know they don't apply Quiet, thats why I was saying they should.

And I can't figure out how anyone could say 18 years and 9 months is hardly the greater evil in question .................. unless it is someone willing to say "I WILL SPEND 9 MONTHS PREGNANT AND 18 YEARS LOVING AND CARING FOR THIS CHILD IN MY HOME" and at that point that person will have my undivided attention.

The people who say "I have decided you must have this child" and immediately after delivery say "just keep that lil brat away from me" do not have my respect as I don't think they grasp the concept of RESPONSIBILITY.

But then, thats just my lil opinion.

I understand your opinion, I was simply pointing out how I felt the other side might feel, and why I felt the other side might not see this as relevant.

...although Charley's post about leaving was less than I expected of someone of her intellect...

Exactly what I was thinking, especially considering what I posted wasn't even close to offensive, but was merely a "remember the other side feels different, and their opinion has to be considered as well" type comment. It amazes me sometimes how we get caught up in our own perspectives, and tend to see others opinions through them, instead of trying to see them unhindered. It's what makes it so hard to deal with those who are religious, this veil they see the world through.

*shrug*

Whatever.

Q_C

 

[Svenskaflicka]

I think that we shouldn't limit the right for abortion to just women who have been raped or in any other way have "earned" the right to terminate an unwanted pregnancy. And I think it's barbaric to tell a woman who has become pregnant against her will to "carry it to terms, you can always give it up for adoption later" - the point is, if she doesn't want to be pregnant and give birth, she shouldn't have to. Period.

She got pregnant through a rape? Through a broken condom? Through negligance due to one drink too many? Whatever!

If she doesn't want to be a mother, she shouldn't have to.

I do agree that if she's already passed into the second trimester, and there's a danger that she could get injured during the abortion, she should talk to a doctor before deciding what to do. But before that - it's her decision.

No-one has the right to decide over a woman's body but herself. That's what it boils down to, IMO. The right to choose for yourself. That's the most important issue.

 

[Lisa Denton]

I understand your opinion, I was simply pointing out how I felt the other side might feel, and why I felt the other side might not see this as relevant.
Q_C

Argh, Ima dyin here.

Quiet sweety, I was makin a point that what some peoples do not consider relevant, I think they should consider it relevant, and you keep saying that them certain peoples might not see it as relevant.

Um, lemme ponder this here a minute ................ OK, I have come to the conclusion that we agree.

(yah, yah, cheers, cheers, thunderous applause)

Have a banana.

 

[Lisa Denton]

(although Charley's post about leaving was less than I expected of someone of her intellect).

Most peoples here are writers, who tend to be opinionated, or like me, a opinionated wannabe writer.

For a person of her intellect to state she was leaving a thread is about the least offensive, least hostile, least confrontational thing I have ever heard.


Back to the subject, what the fuck was we talkin about?

 

[Guest]

Most peoples here are writers, who tend to be opinionated, or like me, a opinionated wannabe writer.

For a person of her intellect to state she was leaving a thread is about the least offensive, least hostile, least confrontational thing I have ever heard.


Back to the subject, what the fuck was we talkin about?

Your gorgeous ass.

 

[Quiet_Cool]

Argh, Ima dyin here.

Quiet sweety, I was makin a point that what some peoples do not consider relevant, I think they should consider it relevant, and you keep saying that them certain peoples might not see it as relevant.

Um, lemme ponder this here a minute ................ OK, I have come to the conclusion that we agree.

(yah, yah, cheers, cheers, thunderous applause)

Have a banana.

Yep. From the beginning we pretty much did. I was merely stating that others might not, based on perspective. Was never arguing. Banana accepted. have a .

Q_C

 

[SesameStreet]

If a woman or child becomes pregnant because of forced incest or rape she should NOT be forced to continue the pregnancy.

Would you?

Yes, I would. And then give it up for adoption. There are so mnay infertile women in the US now who want to adopt babies that the waiting period is up to seven or eight years. The ones who have enough money go overseas and adopt like Angelina Jolie did. I do not believe in killing a fertilized ovum. To me that fertilized ovum is a person.

The problem that I have with Plan B is that I am troubled by the statement that it can interfere with the implantation of an egg in the prepared lining of the uterus. As I understand it only a fertilized ovum will implant itself. An egg that is not fertilized will not implant. So interferrence with implantation by Plab B Pills seems to be no different than having an early abortion.

HOW DOES PLAN B WORK?

Plan B works through delaying or preventing ovulation, by interfering with fertilization (inhibiting the movement of the egg or the sperm through the fallopian tube), and may inhibit implantation by altering the lining of the uterus. It is not effective if the process of implantation has begun. Plan B will NOT cause a miscarriage. Plan B does not provide any protection or treatment against sexually transmitted infections. Pregnancies occurring despite treatment do not have an increased risk of adverse outcome.

http://www.mckinley.uiuc.edu/Handouts/plan_b_contraception.html

 

[SEVERUSMAX]

Still reserving judgment on 2nd trimester. Pretty damn sure that 1st trimester isn't murder, but 3rd is. I don't buy into the whole "zygote is a human life" deal. I also don't believe that child that is viable outside the womb is a mere "cluster of cells". Sometimes, common sense might be a useful barometer, you know.

 

[Svenskaflicka]

Yes, I would. And then give it up for adoption. There are so mnay infertile women in the US now who want to adopt babies that the waiting period is up to seven or eight years. The ones who have enough money go overseas and adopt like Angelina Jolie did. I do not believe in killing a fertilized ovum. To me that fertilized ovum is a person.
[/url]

There are thousands of orphans in the streets of South America who'd love to have someone adopt them so they won't have to become drug dealers and hookers at the age of 5...

Care to wait a little longer in line, to help someone who's already alive and in need of help?

Or does it have to be a white child, adopted away by a woman who never wanted it in the first place?

 

[sweetnpetite]

I'm a murderer. To ME, it's nothing but a cluster of cells. Removing them is not murder in MY eyes.

We are all a cluster of cells.

And many would make the argument that that's ALL we are.

 

[Guest]

Yes, I would. And then give it up for adoption. There are so mnay infertile women in the US now who want to adopt babies that the waiting period is up to seven or eight years. The ones who have enough money go overseas and adopt like Angelina Jolie did. I do not believe in killing a fertilized ovum. To me that fertilized ovum is a person.

The problem that I have with Plan B is that I am troubled by the statement that it can interfere with the implantation of an egg in the prepared lining of the uterus. As I understand it only a fertilized ovum will implant itself. An egg that is not fertilized will not implant. So interferrence with implantation by Plab B Pills seems to be no different than having an early abortion.

http://www.mckinley.uiuc.edu/Handouts/plan_b_contraception.html

There are indeed many infertile women in this country. And the waiting period for a baby is especially long.

But there are thousands of institutionalized orphan children in need of good homes. Not babies, and of all different ethnicities, but still children. Unwanted due to circumstances, but still important. Still people.

About Plan B? Primarily, it prevents the egg from being released in the first place.

http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm

FDA's Decision Regarding Plan B: Questions and Answers

1. What is emergency contraception?

Emergency contraception is a method of preventing pregnancy to be used after a contraceptive fails or after unprotected sex. It is not for routine use. Drugs used for this purpose are called emergency contraceptive pills, post-coital pills, or morning after pills. Emergency contraceptives contain the hormones estrogen and progestin (levonorgestrel), either separately or in combination. FDA has approved two products for prescription use for emergency contraception – Preven (approved in 1998) and Plan B (approved in 1999).

2. What is Plan B?

Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce a woman’s risk of pregnancy when taken as directed if she has had unprotected sex. Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription

3. How does Plan B work?

Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

4. What steps did FDA take in considering switching Plan B from prescription to nonprescription (over-the-counter (OTC)) status?

FDA received an application to switch Plan B from prescription to nonprescription status. FDA staff reviewed the scientific data contained in the application which included among other data, an actual use study and a label comprehension study.

On December 16, 2003, we held a public advisory committee meeting with a panel of medical and scientific experts from outside the federal government. The members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. Although the joint committee recommended to FDA that this product be sold without a prescription, some members of the committee, including the Chair, raised questions concerning whether the actual use data were generalizable to the overall population of nonprescription users, chiefly because of inadequate sampling of younger age groups.

Following the advisory committee meeting, FDA requested additional information from the sponsor pertaining to adolescent use. The sponsor submitted this additional information to FDA in support of their pending application to change Plan B from a prescription to an over-the-counter product. This additional information was extensive enough to qualify as a major amendment to the NDA. Under the terms of the Prescription Drug User Fee Act (PDUFA) performance goals, major amendments such as this may trigger a 90-day extension of the original PDUFA deadline.

Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable.

5. Why didn’t FDA follow the recommendation of the Advisory Committees?

The recommendations of FDA advisory committees are advisory in nature and the Agency is not bound to follow their recommendations. FDA makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

6. Why did FDA issue a Not Approvable letter?

The agency issued a Not Approvable letter because the supplemental application did not meet the criteria for approval in that it did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner. The issuance of a Not Approvable letter does not mean that a supplemental application cannot be approved. The Not Approvable letter describes what the applicant would need to do to obtain approval for the supplemental application. In this case, the applicant would have to either provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug or provide additional support for the revised indication to allow for marketing Plan B as prescription-only for women under the age of 16 and as nonprescription for women 16 years of age and older. Not Approvable Letter.

7. Was there a difference of opinion within the Center for Drug Evaluation (CDER) and Research regarding the final decision?

Yes, there was a difference of opinion within CDER. The scientific interchange of ideas is widely encouraged during the review process to ensure a thorough vetting of the issues. However, ultimately, a final decision must be made based on the evaluation of the data, taking into account all of the views expressed.

8. Is this FDA’s final decision regarding the availability of Plan B for OTC use?

No. The Not Approvable letter to the sponsor outlines what the sponsor must do to obtain approval of the supplemental application.

Wide availability of safe and effective contraceptives is important to public health. We look forward to working with the sponsor if they decide to pursue making this product available without a prescription.

9. Oral contraceptives have been used for four decades, and this product has been approved and used safely since 1999. How could FDA turn it down?

Oral contraceptives as a class of drugs are only available by prescription. This product has been used safely by prescription only and for the reasons already stated, it is not being made available for OTC use at this time.

10. The sponsor has talked about making the product over-the-counter for young women over a certain age and behind-the-counter for younger girls. Is there evidence to support such a scheme? Does FDA have the authority to carry it out?

The sponsor has submitted a plan and the FDA is examining its regulatory authority to approve a product marketed in this manner.

11. Did the FDA bow to political pressure in making this decision?

No. This decision was made within the Center for Drug Evaluation and Research.

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?

No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

 

[shereads]

Yes, I would. And then give it up for adoption. There are so mnay infertile women in the US now who want to adopt babies that the waiting period is up to seven or eight years.

On my planet, there are three problems that have apparently been solved on yours:

(1) Tens of thousands of babies spend their entire childhood in temporary foster care and institutions, because they were born imperfect or just non-white.

I have friends who bypassed that seven-to-eight-year waiting list quite handily, by agrreeing to adopt a mixed-race child. If you're willing to take one born HIV-positive or damaged by fetal alcohol syndrome, or an otherwise healthy infant born deformed or mentally retarded, they're more numerous than free kittens. All you have to do is prove that you can and will provide for the child's needs, better than an institution. There are surprisingly few takers.

And that's just in the USA.

(2) In the third world, an estimated 30,000 children die every day from malnutrition-related causes; many of them were born to mothers who had already buried at least one child and were pregnant with the next - conceived against their will, by societies who not only deny them birth control, but the right to refuse to have sex.

If babies got half the attention given to zygotes, the "culture of life" wouldn't be such a joke.

(3) Pregnancy and childbirth pose substantial health risks, especially to young teenagers, whose bodies may be fertile before they're fully developed.

I'm always amazed at how easily some people offer adoptioin as a solution - as if the woman just needed a maternity wardrobe and a place to put down her burden after nine months.

No matter how many infertile women are on waiting lists for babies, your willingness to risk the health and even the lives of girls and women with unwanted pregnancies is abhorent and disingenuous. You aren't concerned with women's needs and wishes if you can consign even one of them to a life-altering, potentially life-threatening event that could have been prevented with a pill.

 

[Lisa Denton]

I have read more of the Plan B stuff, like why it has its name, is for after plan A fails, broken condom, etc.

I think many of the pregnacies which would occur if this were not available would be the unwanted children. Not the children who there is a waiting list for. Not the newborn, perfectly healthy white babies.

The older children, unwanted, possibly damaged emotionally, from neglect. There is no waiting list for these children.

The babies born whose mothers could not afford to eat and exercise right, to see a doctor regularly, possibly damaged physically, there is no waiting list for these children.

Those born in abusive situations, possibly damaged emotionally and phsically, no waiting list for these children.

If plan A failed, there should be a plan B available, because these are children YOU do not want, JUST COME OUT AND SAY IT.

In my idealistic perfect fantasy world, I wonder what would happen if every person who opposes abortion adopted a child, not a perfect child, but a child that they demanded should be brought into this world, possibly damaged.

No woman should be forced to deliver any child, and never one resulting from a rape or incest. But I will put this out to meet everyone halfway. What if there was a law, that a woman whose pregnancy resulted from a failed plan A, were forced to deliver that child, and everyone who demanded that child be delivered, be forced to adopt a child?

(Lisa braces for a flood)

 

[shereads]

"If men could give birth, abortion would be a sacrament."

~ Gloria Steinem

 

[yevkassem72]

So, some of us are opposed to murdering unborn children, and that makes US irresponsible? Is it not MORE irresponsible to kill a child, simply so that your own life will be easier? Isn't that the sort of thing that we send sociopaths to prison for? Just a thought.

I don't mean to malign anyone, but I believe in calling a spade a spade. I still think that many of the pro-death camp are prudes who can't live by their own rules and must therefore cover up the "sin" by murdering a child. And what is with punishing an innocent child for the rape or incest committed by parents? Is that not savagery? Who else will you propose to punish for the crimes of fathers and mothers?

This whole thing reminds me of an employee murdering an inconvenient colleague to rise to a higher position or a man or woman murdering an inconvenient spouse to avoid the expense of divorce. That's how sick and selfish it seems to me.

Someone else's baby is THEIR responsibility and moral duty to raise instead of killing, to protect, and provide. This shows a distinct lack of maternal instinct, in my opinion. I, for one, am glad that, unborn and unwanted or not, none of the most rabid pro-deathers are my mother. I wouldn't want anything to do with such parents. Not trying to be cruel, but I'd be afraid for my life until I turned 18 and safe. Even then, I might worry. They might murder me to spend my college money on a cruise. What kind of mothers are we talking about here? Where is the famed feminine compassion and love? Where is the nurturing side? I don't see it in women who murder their kids. These women are no better than Susan Smith or Andrea Yates.

 

[cloudy]

So, some of us are opposed to murdering unborn children, and that makes US irresponsible? Is it not MORE irresponsible to kill a child, simply so that your own life will be easier? Isn't that the sort of thing that we send sociopaths to prison for? Just a thought.

I don't mean to malign anyone, but I believe in calling a spade a spade. I still think that many of the pro-death camp are prudes who can't live by their own rules and must therefore cover up the "sin" by murdering a child. And what is with punishing an innocent child for the rape or incest committed by parents? Is that not savagery? Who else will you propose to punish for the crimes of fathers and mothers?

This whole thing reminds me of an employee murdering an inconvenient colleague to rise to a higher position or a man or woman murdering an inconvenient spouse to avoid the expense of divorce. That's how sick and selfish it seems to me.

Someone else's baby is THEIR responsibility and moral duty to raise instead of killing, to protect, and provide. This shows a distinct lack of maternal instinct, in my opinion. I, for one, am glad that, unborn and unwanted or not, none of the most rabid pro-deathers are my mother. I wouldn't want anything to do with such parents. Not trying to be cruel, but I'd be afraid for my life until I turned 18 and safe. Even then, I might worry. They might murder me to spend my college money on a cruise. What kind of mothers are we talking about here? Where is the famed feminine compassion and love? Where is the nurturing side? I don't see it in women who murder their kids. These women are no better than Susan Smith or Andrea Yates.

you're obviously male.

 

[yevkassem72]

you're obviously male.

Irrelevant. I don't mean to be cruel, but there ARE female pro-lifers, you know. They have to go through it, and yet, they are willing. What do you have to say to them? They hold many of the same views that I just expressed. Are they lacking in empathy? Are they male chauvinist pigs too? Does it follow that anyone opposed to the 21st Century Holocaust of the unborn is automatically a misogynist? Food for thought.

Having lurked for a while, I like you guys. You might hate me now, but I like you. I just have strong ethical qualms about infanticide.

 

[cloudy]

Irrelevant. I don't mean to be cruel, but there ARE female pro-lifers, you know. They have to go through it, and yet, they are willing. What do you have to say to them? They hold many of the same views that I just expressed. Are they lacking in empathy? Are they male chauvinist pigs too? Does it follow that anyone opposed to the 21st Century Holocaust of the unborn is automatically a misogynist? Food for thought.

Having lurked for a while, I like you guys. You might hate me now, but I like you. I just have strong ethical qualms about infanticide.

I do too, but I don't consider first trimester abortion infanticide.

It's MY body, and you have absolutely no right whatsoever to tell me what I can and can't do with it. Period.

 

[yevkassem72]

I do too, but I don't consider first trimester abortion infanticide.

It's MY body, and you have absolutely no right whatsoever to tell me what I can and can't do with it. Period.

That's debatable. 2nd and 3rd is less so. All of the data that I have indicates that is infanticide beginning at least in the 2nd trimester, because the unborn at that stage are probably alive and conscious.

 

[Lisa Denton]

And what is with punishing an innocent child for the rape or incest committed by parents? Is that not savagery? Who else will you propose to punish for the crimes of fathers and mothers?

You lost me with the crime of rape being committed by parents.

And you went well beyond the fringe by mentioning rape, incest, and parents in the same sentence.

Thats not funny.

 

[Guest]

That's debatable. 2nd and 3rd is less so. All of the data that I have indicates that is infanticide beginning at least in the 2nd trimester, because the unborn at that stage are probably alive and conscious.

They are alive, yes. Always have been. Cells are alive. Though I find it difficult to equate a rapidly multiplying microscopic bundle of cells as something that is conscious.

Brain function, by the way, does not equate conscious thought. I'd love to see some recent research on the 2nd trimester consciousness of fetuses. I'm assuming you've read and can provide same? (If not, keep your opinions to yourself.)

So you've been here in the Author's Hangout for awhile, lurking and liking us all behind our backs. Then once you join in, you immediately call everyone who believes in a woman's right to control her own body's functions a murderer. And you continue by comparing us to Susan Smith and Andrea Yates.

Fuck you. Go back to lurking.

 

[rgraham666]

Two thirds of fertilised human ova don't come to term under the most ideal of conditions. Are we going to check every woman to see if their ova are fertilised and take action against them?

An IUD prevents the egg from implanting. Are we going to charge the doctors who prescribe them and women who use them?

yevkassem72? Your comparing of any abortion to infanticide is utter bollocks. A zygote is not a child. Making the comparison you did is a low piece of propaganda designed to end any debate on this matter.

I don't hate you for that. But I couldn't be bothered to listen to you anymore. You have nothing useful to say.

 

[SEVERUSMAX]

They are alive, yes. Always have been. Cells are alive. Though I find it difficult to equate a rapidly multiplying microscopic bundle of cells as something that is conscious.

Brain function, by the way, does not equate conscious thought. I'd love to see some recent research on the 2nd trimester consciousness of fetuses. I'm assuming you've read and can provide same? (If not, keep your opinions to yourself.)

So you've been here in the Author's Hangout for awhile, lurking and liking us all behind our backs. Then once you join in, you immediately call everyone who believes in a woman's right to control her own body's functions a murderer. And you continue by comparing us to Susan Smith and Andrea Yates.

Fuck you. Go back to lurking.

I personally think that the man is entitled to his opinions, Sarah. You might not share them, but that's a matter of free speech and all, right? He has 1st Amendment rights too, you know. So he said something that you don't like. Do you really want to drive away a former lurker in the name of a political viewpoint? We all have political ideas that we don't share. I am not vicioius to people because of their politics. I don't tell them to "go back to lurking".

Yes, he said something controversial, and some might say it is harsh. But this is a thread that invites opposing views. At the most, he might be another Ami. If you can stand Ami, why not this yevkassem guy? Just a question. He is a free man expressing his unpopular views. It takes courage to stand on an unpopular principle. Is that really the sort of man that we want to chase off from our AH? A man of character and conviction? A man who is probably very good to people and a good citizen, but just has a minority viewpoint?

Just defending his right to his views.

Remember what Voltaire said, "I disagree with what you have to say, but will defend to the death your right to say it."

I happen to hold the same stand as Voltaire. No matter how repugnant someone's views might be, it is their right to uphold them. Especially on a public forum.

 

[SeaCat]

An interesting debate, and one I hope continues.

I find myself almost hesitant to voice my views on this.

All of us make choices, choices in how we live and how we believe. These are our personal choices and therefore should not be pushed on others. I am a strong believer in this. I am also a strong believer in accepting responsibilty for ones actions.

With this said I do not question the morality of those who wish to carry to term, nor do I question the morality of those who wish to terminate. These are their choices. I do however question the morality of those who choose to push their choices on the rest of us.

If you choose to push your values on me or my family, I will respond in a very painfull manner. I have my rights and my values as do you. I do not push mine on you, and I will not allow you to push yours on me.

On the other hand, I do not expect you to pay for my choices either financialy or morally. Therefore I do not wish to pay for your choices.

Cat

 

[Guest]

I personally think that the man is entitled to his opinions, Sarah. You might not share them, but that's a matter of free speech and all, right? He has 1st Amendment rights too, you know. So he said something that you don't like. Do you really want to drive away a former lurker in the name of a political viewpoint? We all have political ideas that we don't share. I am not vicioius to people because of their politics. I don't tell them to "go back to lurking".

Yes, he said something controversial, and some might say it is harsh. But this is a thread that invites opposing views. At the most, he might be another Ami. If you can stand Ami, why not this yevkassem guy? Just a question. He is a free man expressing his unpopular views. It takes courage to stand on an unpopular principle. Is that really the sort of man that we want to chase off from our AH? A man of character and conviction? A man who is probably very good to people and a good citizen, but just has a minority viewpoint?

Just defending his right to his views.

Remember what Voltaire said, "I disagree with what you have to say, but will defend to the death your right to say it."

I happen to hold the same stand as Voltaire. No matter how repugnant someone's views might be, it is their right to uphold them. Especially on a public forum.

SEV - he's entitled to his views, but I am entitled to mine, including having the right to tell him to fuck off. He called me a murderer, hon. He doesn't deserve my respect or another moment of my time.

His rights are mine as well.