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Debate on Selling Morning-After Pill Over the Coun

Medicine Abortion Pill Debate 2003

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#1 Shalamar

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Posted 13 December 2003 - 06:24 AM

Debate on Morning After Pill over the counter

Quote

Two panels for the Food and Drug Administration  will consider early next week whether to allow the so-called morning-after pill, now a prescription drug taken after intercourse to prevent pregnancy, to be sold over the counter.

But unlike other more ordinary hearings for drugs like allergy medications to be shifted from prescriptions, this hearing has become entangled in the thorny politics of abortion, raising questions of when a pregnancy begins and who decides.

If approved, the drug would be the first emergency contraceptive sold over the counter. Known as Plan B when Plan A, for contraception, fails or is skipped the drug would not only be sold in drugstores, but could also be as available as aspirin, on supermarket shelves or in convenience stores or gasoline stations. The drug, essentially two high-dose birth control pills, can prevent up to 89 percent of unwanted pregnancies if taken within 72 hours of unprotected intercourse. But the sooner it is taken, the more effective it is.

I am pro choice and this, to me, is an option that should be available. Though later in the article they do mention worries about teenagers possibly taking the drug repeatedly and not telling any one if complications arrise...

Perhaps available but with restrictions as to age ...like tobbacco and alcohol?
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#2 Lord of the Sword

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Posted 13 December 2003 - 08:30 AM

Shalamar, on Dec 13 2003, 07:24 AM, said:

Perhaps available but with restrictions as to age ...like tobbacco and alcohol?
Sounds like an excellent idea to me.
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#3 Rov Judicata

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Posted 13 December 2003 - 10:06 AM

89% effective? For something that has the potential to be life-destroying, I don't like those odds....

Anyway, it's not the FDA's place to worry about the political ramifications of abortion; it's not their place. Their only question should be how medically safe it is for the girl.

Here's the kicker:

Quote

Opponents say the over-the-counter rule would be an invitation to medical nightmares, with some people, particularly teenagers, using the pills repeatedly and not telling anyone even if they have complications. The safety of repeated use has not been well studied.

Translation: "Well, we don't have any actual evidence that there's a problem... but we have conjecture and hypothetical scenarios! Those are TYPES of evidence!"

EDIT:

Quote

Perhaps available but with restrictions as to age ...like tobbacco and alcohol?

Wouldn't that just make those who we least want to become pregnant-- teenagers-- the least able to deal with their condition?

Edited by Javert Rovinski, 13 December 2003 - 10:10 AM.

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#4 Kimmer

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Posted 13 December 2003 - 12:56 PM

There have been two confirmed deaths from this pill in my area in the past few months - and both were young women under a doctors care. I don't think this pill is as safe as the FDA says and I'm totally against it being sold without a prescription.

This also brings us to another point - more and more pharmaseuticals are being moved to OTC; thus my HMO now covers less and less. The cough syrup my husband needed is no longer covered as the ones now available OTC are "almost as good". The more stuff this becomes OTC, the worse our health care system becomes - and it's already a national nightmare and disgrace.

#5 Bad Wolf

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Posted 13 December 2003 - 04:09 PM

I am very pro choice.  But abortion is (and should be) a very very thought out course of action.  Making it available in the same way aspirin is available puts the ramifications of  engaging in unprotected sex the same place as a headache or the flu and I'm afraid I oppose that.  Add to that the safety risks and effectiveness issues brought up by Rov and kimmer and you can put me firmly in the "no" column.  I don't oppose a safe effective "morning" after pill, especially for rape victims, but it should not be a contraceptive.  Also I've read up on the physical effects of it.  It is not pleasant at all to take this thing.
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#6 Godeskian

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Posted 13 December 2003 - 04:23 PM

kimmer, on Dec 13 2003, 06:56 PM, said:

There have been two confirmed deaths from this pill in my area in the past few months - and both were young women under a doctors care. I don't think this pill is as safe as the FDA says and I'm totally against it being sold without a prescription.
It was my understanding that the pill was essentially safe. Do you have links for these stories, i'd like to read up on them?

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#7 Kimmer

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Posted 13 December 2003 - 04:57 PM

Godeskian, on Dec 13 2003, 01:23 PM, said:

kimmer, on Dec 13 2003, 06:56 PM, said:

There have been two confirmed deaths from this pill in my area in the past few months - and both were young women under a doctors care. I don't think this pill is as safe as the FDA says and I'm totally against it being sold without a prescription.
It was my understanding that the pill was essentially safe. Do you have links for these stories, i'd like to read up on them?
I'll look for them, but since they were local girls and it was my local paper - they probably aren't archived. :(

#8 Delvo

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Posted 13 December 2003 - 05:28 PM

Javert Rovinski, on Dec 13 2003, 09:06 AM, said:

it's not the FDA's place to worry about the political ramifications of abortion; it's not their place. Their only question should be how medically safe it is for the girl...

Quote

Opponents say the over-the-counter rule would be an invitation to medical nightmares, with some people, particularly teenagers, using the pills repeatedly and not telling anyone even if they have complications. The safety of repeated use has not been well studied.
Translation: "Well, we don't have any actual evidence that there's a problem... but we have conjecture and hypothetical scenarios! Those are TYPES of evidence!"
Why did you say the FDA should be concerned only about the thing's safety and then mock the idea that they should investigate the thing's safety? Concern about an un-investigated drug's safety isn't hysterical hand-waving over nothing; it's pointing out that the FDA should do its job.

And if it's "evidence" you want, take a look at the side-effects that are known to routinely come from using it already, and consider how safe something can be assumed to be if it does that all the time to most normal healthy people. The FDA is supposed to be restrictive and demanding about the safety of all drugs anyway,

Quote

Quote

Perhaps available but with restrictions as to age ...like tobbacco and alcohol?
Wouldn't that just make those who we least want to become pregnant-- teenagers-- the least able to deal with their condition?
It would give them the least reason to expect to be able to do what it takes to get pregnant in the first place and "get away with it" consequence-free.

Edited by Delvo, 13 December 2003 - 05:36 PM.


#9 Rov Judicata

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Posted 13 December 2003 - 05:34 PM

Quote

Kimmer: I'll look for them, but since they were local girls and it was my local paper - they probably aren't archived

Actually, the incident is mentioned in the article. I only found the one, however:

Quote

Dr. Wendy Wright, policy director for Concerned Women for America, said a recent death of a California teenager who took RU-486 without telling her parents or without further medical supervision, showed that teenagers could take major risks when they feared pregnancy.

Doing more research, it's an 18-year old "Holly Patterson".

Doing yet more research:

http://www.smdailyjo...3&storyID=25554

Quote

According to Whittington, one dose of the RU-486 regimen was given to Patterson in-office, and she was advised to take the regimen’s second drug, misoprostol, vaginally at home two days later.

Quote

Brooks asserted the drug’s safety by saying more than 200,000 women have successfully used mifepristone, or RU-486, since it was approved by the U.S. Food and Drug Administration in 2000.

She also said that although federal guidelines for the RU-486 regimen stipulate the oral administration of the drug, studies have shown that vaginal insertion is “very safe and effective.”

Planed Parenthood may have liability for defying federal guidelines. But the bottom line is that there are lots of medications out there that can be fatal if taken the wrong way...

Edited by Javert Rovinski, 13 December 2003 - 05:45 PM.

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~~ Josh, winning the argument.

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#10 Rov Judicata

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Posted 13 December 2003 - 05:44 PM

Quote

Why did you say the FDA should be concerned only about the thing's safety and then mock the idea that they should investigate the thing's safety? Concern about an un-investigated drug's safety isn't hysterical hand-waving over nothing; it's pointing out that the FDA should do its job.

Perhaps I should have made that more clear. Evaluating the safety is very important. However, most of these groups are using safety as a 'hook', not their real argument.

If this drug were for something *other* than abortion, would the "United States Conference of Catholic Bishops, Concerned Women for America and 44 members of Congress, including the House majority leader" be giving their opinion? Are we to believe that CWA and USCCB have suddenly developed an interest in drug safety?

No, they say it themselves:

Quote

"When it comes to contraception as a policy issue access, availability the Catholic bishops do not get involved in that debate," a spokeswoman for the bishops, Cathy Cleaver Ruse, said. "But when it comes to abortion, that's a different matter. It's far greater than just a religious issue. It's a human rights issue."

That's a completely inappropriate within the context of an evaluation of the drug's safety. Let's look again at the questions:

Quote

The advisory panels will also review research and hear experts on whether Plan B meets the over-the-counter criteria. They include can patients decide for themselves whether to take it? Can they use it properly? Are its side effects relatively minor and self-limited?

Now, this could go either way... but it has to be based on the criteria the FDA is assigned to evaluate.

Quote

And if it's "evidence" you want, take a look at the side-effects that are known to routinely come from using it already, and consider how safe something can be assumed to be if it does that all the time to most normal healthy people. The FDA is supposed to be restrictive and demanding about the safety of all drugs anyway,

Granted, the side effects aren't pretty. In many cases, though, they're better than the alternative...

Quote

It would give them the least reason to expect to do what it takes to get pregnant in the first place and "get away with it" consequence-free.

Somehow, I'm skeptical the fear of pregnancy is going to lead to abstinence.
St. Louis must be destroyed!

Me: "I have a job and five credit cards and am looking into signing a two year lease.  THAT MAKES ME OLD."
Josh: "I don't have a job, I have ONE credit card, I'm stuck in a lease and I'm 28! My mom's basement IS ONE BAD DECISION AWAY!"
~~ Josh, winning the argument.

"Congress . . . shall include every idiot, lunatic, insane person, and person non compos mentis[.]" ~1 U.S.C. § 1, selectively quoted for accuracy.

#11 MuseZack

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Posted 13 December 2003 - 06:35 PM

Correct me if I'm wrong, but aren't nearly all non-barrier based forms of birth control (birth control hormones, IUD devices) post-conception in nature?  That is to say, they work by preventing the fertilized egg from attaching to the uterine wall?  If this is the case, how are they substantively different than the morning-after pill?  And if we do accept things like the Pill, why not have an available birth control choice for people who make bad reproductive decisions in the heat of the moment?

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#12 GiGi

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Posted 13 December 2003 - 08:12 PM

^You are correct Zack.  IUDs are especially dangerous, I have known of many women who got very sick from infections from those things.  So in essence they do the same thing as RU486, which is to stop the fertilized egg from implanting in the the uterus wall.  In the early 80s some friends of mine took Pennyroyal oil to do the same thing.  It is also dangerous and poisonous if too much is taken.

The only birth control method I know of that is not dangerous to the woman is a vasectomy!  Or if the women gets her tubes tied, that is a pretty safe procedure.

As to getting the abortion pill over the counter, I agree with Lil, it is something that should be done with a doctor's care and not equivalent to an aspirin.

Here is a link to the article about Holly that was in the Chronicle - Questions abound about why prenant teen died Experts not quick to blame abortion pill

The thing that is dangerous about RU486 is the same thing that is dangerous with a miscarriage (which I had) is getting an infection (which happened to me also).  It needs to be treated by a medical professional (which I did).
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#13 Bad Wolf

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Posted 14 December 2003 - 04:23 AM

MuseZack, on Dec 13 2003, 03:35 PM, said:

And if we do accept things like the Pill, why not have an available birth control choice for people who make bad reproductive decisions in the heat of the moment?

Zack
The Pill is not OTC.  All I'm saying is that this thing should not be OTC (which is the subject matter of this thread).
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#14 Delvo

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Posted 14 December 2003 - 08:41 AM

Contraceptive pills do not cause a fertilized egg to die; they prevent fertilization by stopping the roughly-monthly release of egg cells to where they even can be fertilized in the first place.

http://www.contracep...ll/how_work.asp

#15 StarDust

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Posted 14 December 2003 - 09:10 AM

The morning after pill is not suppose to replace birth control. It's suppose to provide a solution in case you got pregnant in a situation where there wasn't birth control. An unplanned event including everything from going out drinking and then having sex in an unresponsible way to getting raped. A woman shouldn't have to essentially get someone else's permission to take care of herself, never mind having to go into private details.

There is no reason it shouldn't be available over the counter. It's no more dangerous than aspirin, which can and has killed. Are we saying nothing should be over the counter? People merely need to follow directions just like they should with everything else, and it's amazing how many people do. I know people who get upset if I take an extra aleve like I'm going to drop dead or something.

As far as OTC affects on health insurance. That is a general concern, yet I'm not so sure. I take Claritin which went OTC this summer.  However it's price was also something like 1/3 what it was OTC and I don't pay much more than what I was paying through medical. OTC it was something like 3.50 a pill now it's less than 1.00 per pill ($25 for 30). My contribution was 15, then 20, when it was prescription. It also helps people who don't have medical.

OTC as far as the Morning After Pill is concerned I don't believe is much of a concern. It's not something you should be taking on any regular basis.

#16 Yama

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Posted 14 December 2003 - 10:42 AM

Well, I am very pro-life, so it may come as no surprise that I oppose dispensing RU-486 over the counter.  However, my opposition is primarily medical: as an abortif agent, I don't think RU-486 is more horrendous than any other method of abortion.

To be blunt and honest, if it were not for the fact that RU-486 is an agent for abortion, I don't think there would be any question that it should not be dispensed without medical supervision.  Yes, this is a case where I think the pro-choice side is playing fast and loose with the medical facts in order to promote their position.  (And yes, I do believe the pro-life side does that, too.)  Unfortunately, abortion has become to much of a political issue -- both pro and con -- for reasoned medical debate on methods or procedures for performing it.  (This is a distinct argument from the moral debate of the appropriateness of abortion in the first place.)

Well Lil, it looks like we are agreeing once again.  Although now from distinctly different viewpoints.  What will our friends say?
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#17 Uncle Sid

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Posted 14 December 2003 - 11:47 AM

Unfortunately, due to the unevenness of the tactics to which each side will go, we're going to see an uneven situation in terms of where people feel that abortion drugs like RU-486 can be reasonably challenged.  

Some people on the pro-life side feel that it's reasonable to use every tactic short of killing people or committing a major crime in order to stem the tide of abortions, and some think we need to not mess around with institutions too much, lest we cause other unforseen problems.  Usually, I'd side with the party that is going to execute the best throught out strategy, however the problem is that abortion isn't an academic situation where you can carefully craft a response that is the most perfect possible result.  If you subscribe to the pro-life position, then what you will probably think that you are witnessing is daily killings all across the country.  Given that sort of pressure, the tactics to deal with abortion are going to have rough, ad-hoc edges and the angles of attack will have to be unorthodox.  

Since there is zero doubt in my mind that the existence of an over-the-counter abortifacent will make abortions even more attractive and frequent (since people can and will act on their initial panic responses without a cooling-off period), I find myself very sympathetic, if not in complete agreement with people who are, honestly, quite possibly using the FDA in a manner in which it was not meant to be used.  Of course, the broad justification is that the FDA would be approving a drug to kill people, which is not really safe.  Unless you are pro-life, though, that argument will probably be seen as trite.  Nevertheless, since OTC approval would really make "abortion on whim" very feasible, allowing it to breeze by the FDA when it could be attacked there is difficult to justify from a pro-life perspective.

Edited by Uncle Sid, 14 December 2003 - 11:48 AM.

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#18 ArmourMe

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Posted 15 December 2003 - 01:22 PM

MuseZack, on Dec 13 2003, 11:35 PM, said:

Correct me if I'm wrong, but aren't nearly all non-barrier based forms of birth control (birth control hormones, IUD devices) post-conception in nature?  That is to say, they work by preventing the fertilized egg from attaching to the uterine wall?  If this is the case, how are they substantively different than the morning-after pill?  And if we do accept things like the Pill, why not have an available birth control choice for people who make bad reproductive decisions in the heat of the moment?

Zack
Actually the pill prevents conception - it suppresses ovulation.

The 2 forms of IUD prevent conception by giving off toxic substances to make the sperm not be able to swim well (one has copper, one has progestin - both keep the sperm from making it to their destination).  Very rarely a wriggler might make it to the egg and then, yes, the foreign object in the uterus prevents implantation, but this is not the operation of the IUD most of the time.

And to answer concerns about infection, practitioners have started very through routine STD testing before they insert the IUD - this has taken incidences of uterine infection down to nothing (since most of the bad infections were caused by the insertion proceedure moving STD's from the vagina into the uterus).  If you don't aquire an STD while the IUD is in place, you don't  have an infection problem. (which is why an IUD is only useful if you're in a mutually monagamous relationship)

I'm a big advocate of the copper IUD - there are so many women out there like me who are allergic to latex, spermacides and react severely to horemonal birthconrol.  Contraception as effective as surgery with almost no side effects that lasts for 12 years is something more women should know exists.

I'll get off this nice little soap box here :)  Can you tell I really like my IUD?

As for the morning after pill being over the counter - I think it needs to be used safely.  Thats my primary concern.  But the morning after pill is NOT RU486.  RU 486 is a combination of very powerful drugs that should never be used without medical supervision.  The morning after pill is a whopping dose of birth control pills.  Much safer.  The problems would arise with people using them repeatedly  - but any enterprising irresponsible person could get ahold of them now repeatedly (jsut by going to different clinics every time).  A good compromise might be that you have to ask the pharmacist directly - so that the pharmacist could give you the safety speil every time - how to take them, that they're NOT intended for regular use, a little education on birth control options etc.

I've had 2 unintended pregnancies as a grown up in a long term (albiet messed up) relationship.  They were both HUGE shocks - andI wasn't a kid or a single mother in harsh financial straits or any one of a number of circumstances that would have made having a child a disaster for the child and myself.  I wouldn't wish an unplanned pregnancy on anyone.  Anything women can do to choose pregnancy or not choose it I support.  And until there's never a circumstance in which a women can have an unplanned pregnancy - until there's no more powerlessness, withholding of education, side-effect laden birth control......until a lot of things change, women need to have as many options available to them as possible.

#19 ArmourMe

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Posted 15 December 2003 - 01:44 PM

Yama, on Dec 14 2003, 03:42 PM, said:

Well, I am very pro-life, so it may come as no surprise that I oppose dispensing RU-486 over the counter.  However, my opposition is primarily medical: as an abortif agent, I don't think RU-486 is more horrendous than any other method of abortion.
The morning after pill (the topic of the original post) is NOT RU486.

The morning after pill is a big dose of regular birth control pills.  TOTALLY DIFFERENT DRUGS.

Yes, the "morning after" pill prevents implantation - if there was a coneception, the morning after dose prevents the egg from implanting successfully in the endometrium.

RU486 is a totally different combination of drugs used AFTER a period is missed and implantation  has happened.  No one is talking about making RU 486 available over the counter!  The drugs are very harsh and must be used exactly right, with someone making very sure there are no complications (like hemmoraging to death).

The morning after pill is extra strong birth control pills - a drug with known risks, but nothing like the RU 486 combination.

#20 Yama

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Posted 15 December 2003 - 04:45 PM

ArmourMe, on Dec 15 2003, 06:44 PM, said:

Yama, on Dec 14 2003, 03:42 PM, said:

Well, I am very pro-life, so it may come as no surprise that I oppose dispensing RU-486 over the counter.  However, my opposition is primarily medical: as an abortif agent, I don't think RU-486 is more horrendous than any other method of abortion.
The morning after pill (the topic of the original post) is NOT RU486.

The morning after pill is a big dose of regular birth control pills.  TOTALLY DIFFERENT DRUGS.

Yes, the "morning after" pill prevents implantation - if there was a coneception, the morning after dose prevents the egg from implanting successfully in the endometrium.

RU486 is a totally different combination of drugs used AFTER a period is missed and implantation  has happened.  No one is talking about making RU 486 available over the counter!  The drugs are very harsh and must be used exactly right, with someone making very sure there are no complications (like hemmoraging to death).

The morning after pill is extra strong birth control pills - a drug with known risks, but nothing like the RU 486 combination.
AmourMe, thank you.  Seriously.  I was aware of the difference between mifepristone (RU-486) and "morning after pills" (my understanding is that there are several "varieties"); but this was a case of responding to previous posts (where RU-486 is mentioned) without reading the original reference.  Mea culpa.

However, I must still oppose dispensing "morning after pills" over the counter.  While I do not think the health issue is as significant as with dispensing RU-486 over the counter, I still think it is "too easy" for minors and others if "morning after pills" were so readily available.  If given the option of either RU-486 or "morning after" contraceptives, I would oppose RU-486 more vigorously but, again and obviously, I oppose both.
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