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RU-486 Users Die After "off-label Use"  
User currently offlineRedngold From United States of America, joined Mar 2000, 6907 posts, RR: 44
Posted (8 years 5 months 2 weeks 1 hour ago) and read 1513 times:

Please read the article, then consider these two questions:

1. If RU-486 is a "safe and effective" manner of providing abortion as labeled, why would Planned Parenthood administer it off-label?

2. Why would Planned Parenthood continue to recommend the off-label administration after women started dying?

http://www.mercurynews.com/mld/monte...=rss&channel=montereyherald_nation


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30 replies: All unread, showing first 25:
 
User currently offlineErikwilliam From Brazil, joined Mar 2004, 2152 posts, RR: 12
Reply 1, posted (8 years 5 months 2 weeks 1 hour ago) and read 1498 times:

Quoting Redngold (Thread starter):
1. If RU-486 is a "safe and effective" manner of providing abortion as labeled, why would Planned Parenthood administer it off-label?

cheaper??easier acess???

Quoting Redngold (Thread starter):
2. Why would Planned Parenthood continue to recommend the off-label administration after women started dying?

has it been proven that it caused death???Some organisms may work in a different way, so....



Dida, Cafu, Lucio, Roque Junior, Roberto Carlo, Emerson, Ze Roberto, Ronaldinho, Kaka, Adriano, Robinho, Ronaldo
User currently offline777236ER From , joined Dec 1969, posts, RR:
Reply 2, posted (8 years 5 months 2 weeks 1 hour ago) and read 1498 times:

Quoting Redngold (Thread starter):

1. If RU-486 is a "safe and effective" manner of providing abortion as labeled, why would Planned Parenthood administer it off-label?

2. Why would Planned Parenthood continue to recommend the off-label administration after women started dying?

Who the hell cares what a pressure group says? Ask your doctor for health advice, don't ask a pressure group, of any colour.


User currently offlineJaysit From , joined Dec 1969, posts, RR:
Reply 3, posted (8 years 5 months 2 weeks 1 hour ago) and read 1497 times:

1. The FDA does not regulate the off-label uses of a drug, unless the marketing firm actively promotes such a use. FDA's policy is that it does not interfere in the "practice of medicine" by physicians, especially since physicians can tweak the conditions of use of a drug, or even prescribe drugs for unapproved uses. In this case, the off-label use, i.e., the vaginal insertion of RU-486, was (a) shown to be safe by physicians both here and the United States; and (b) is undergoing clinical trials for eventual approval by the FDA. This is not rare - many drugs are used more in an "off-label" mode than what is indicated on the label, partly because upon wide-spread use of the drug in the population at large, you get a better statistical picture than you do in clinical trials which are conducted on smaller patient groups (100-1000 patients). "Off-label uses," if successful, do eventually make it to FDA's purview, because a firm would prefer to openly market a drug for such a use than rely on what a few doctors would recommend. In fact, many cancer drugs became useful in such a manner.

2. Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents. What are you reading? In fact, none of the uses of RU-486 have been shown to be the cause of death in any of the cases.

3. Statistically, RU-486 is very safe. Every drug has some risk associated with it - even a simple drug like Advil. That is why every drug label comes with warnings.

If we yanked every drug that had even a causal relationship to a death, we would have no pharmaceuticals left on the shelves. In the cases of drugs like Advil, the causal relationship has been proven, but the number of people it affects is so miniscule, or because the deaths associated with it are caused only by misuse of the drug, it is deemed safe. So with RU-486. Of course, since the use of RU-486 is far more complicated than mere Advil, any adverse event obviously creates some worry. Needless to say, its been used in Europe and the US very successfully.

[Edited 2006-03-20 20:04:39]

User currently offlineDougloid From , joined Dec 1969, posts, RR:
Reply 4, posted (8 years 5 months 2 weeks 1 hour ago) and read 1490 times:

Quoting Jaysit (Reply 3):
1. The FDA does not regulate the off-label uses of a drug, unless the marketing firm actively promotes such a use. FDA's policy is that it does not interfere in the "practice of medicine" by physicians, especially since physicians can tweak the conditions of use of a drug, or even prescribe drugs for unapproved uses. In this case, the off-label use, i.e., the vaginal insertion of RU-486, was (a) shown to be safe by physicians both here and the United States; and (b) is undergoing clinical trials for eventual approval by the FDA. This is not rare - many drugs are used more in an "off-label" mode than what is indicated on the label, partly because upon wide-spread use of the drug in the population at large, you get a better statistical picture than you do in clinical trials which are conducted on smaller patient groups (100-1000 patients). "Off-label uses," if successful, do eventually make it to FDA's purvey, because a firm would prefer to openly market a drug for such a use than rely on what a few doctors would recommend. In fact, many cancer drugs became useful in such a manner.

2. Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents. What are you reading? In fact, none of the uses of RU-486 have been shown to be the cause of death in any of the cases.

3. Statistically, RU-486 is very safe. Every drug has some risk associated with it - even a simple drug like Advil. That is why every drug label comes with warnings.

If we yanked every drug that had even a causal relationship to a death, we would have no pharmaceuticals left on the shelves. In the cases of drugs like Advil, the causal relationship has been proven, but the number of people it affects is so miniscule, or because the deaths associated with it are caused only by misuse of the drug, it is deemed safe. So with RU-486. Of course, since the use of RU-486 is far more complicated than mere Advil, any adverse event obviously creates some worry. Needless to say, its been used in Europe and the US very successfully.

Why the overreaction?

You're spending too much time in Festung Washington, brother. It'd do you a world of good to find out what the people in this country, not on the shaky side or the dirty side think about this issue among a host of others.


User currently offlineJaysit From , joined Dec 1969, posts, RR:
Reply 5, posted (8 years 5 months 2 weeks ago) and read 1481 times:

Quoting Dougloid (Reply 4):
Why the overreaction?

You're spending too much time in Festung Washington, brother.

I'm giving you the cold, hard facts, not the lousy sound bites that you're prone to.

If you prefer to rot in your ignorance and spout inane aphorisms, however, that's your problem.

Next.


User currently offlineDL021 From United States of America, joined May 2004, 11447 posts, RR: 75
Reply 6, posted (8 years 5 months 2 weeks ago) and read 1460 times:
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Quoting Erikwilliam (Reply 1):
has it been proven that it caused death???Some organisms may work in a different way, so....

well, there's some evidence that's linking certain usages of the drug to deaths, particularly when used in a secondary manner directly applied vaginally.

Quoting 777236ER (Reply 2):
Who the hell cares what a pressure group says? Ask your doctor for health advice, don't ask a pressure group, of any colour.

Amen to that. No one....and that means your sister-in-law who uses her brothers Ambien to fall asleep on airplanes....other than a doctor merits your attention or desire for blessing when it comes to drugs.

Quoting Jaysit (Reply 3):
Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents.

There's some evidence that individuals have done this and there's an investigation happening now. No one wants to admit any group culpability, and no one wants to damage the credibility of the drug (at least from that organization) so I don't see this being made much more public unless an outside force pushes it.

Quoting Jaysit (Reply 5):
If you prefer to rot in your ignorance and spout inane aphorisms

Please stop using such big words.....I'll need an Advil and they seem to have side-effects for which I'll blame you......  Wink



Is my Pan Am ticket to the moon still good?
User currently offlineN1120A From United States of America, joined Dec 2003, 26444 posts, RR: 75
Reply 7, posted (8 years 5 months 2 weeks ago) and read 1441 times:

Quoting 777236ER (Reply 2):
Who the hell cares what a pressure group says? Ask your doctor for health advice, don't ask a pressure group, of any colour.

Planned Parenthood isn't a pressure group, it is a non-profit organization that makes sure people have reliable access to birth control, abortion and sexual health testing and treatment. They employ doctors who prescribe medicines of all types, including surgeons who perform surgical abortions.

Quoting DL021 (Reply 6):
well, there's some evidence that's linking certain usages of the drug to deaths, particularly when used in a secondary manner directly applied vaginally.

Actually...

Quote:
The rate of sepsis (with RU486) is about one in 100,000 uses, comparable to infection risks with surgical abortions and childbirth.



Quote:
Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, an ''off-label'' use that studies have shown effective and that has been recommended by a majority of the nation's abortion clinics. That use does not have federal approval though studies have indicated it produces fewer side effects.



Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
User currently offlineJaysit From , joined Dec 1969, posts, RR:
Reply 8, posted (8 years 5 months 2 weeks ago) and read 1441 times:

Quoting DL021 (Reply 6):
Quoting Jaysit (Reply 3):
Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents.

There's some evidence that individuals have done this and there's an investigation happening now.

There is? Where? FDA ruled earlier that the 4 deaths associated with RU-486 were not drug related, and so physician promoted vaginal use was never stopped. In fact, even if "individuals" have done this, they were within the metes and bounds of the prevailing science.

I think what the anti-abortion factions are doing here is using the M.O. of those penny ante tort lawyers who go after drugs like Celebrex, etc., in the hope of sueing the pharma companies up the wazoo. Here of course, their motives are different, but its highly unlikely that this strategy will succeed based on the statistics we see. Of course, RU-486 can still be shown to be unsafe by doctors and biostatisticians, and if so, should be pulled. But what we are witnessing now is just the usual transparent anti-choice noise.


User currently offlineRedngold From United States of America, joined Mar 2000, 6907 posts, RR: 44
Reply 9, posted (8 years 5 months 2 weeks ago) and read 1433 times:

Quoting Erikwilliam (Reply 1):

cheaper??easier acess???

No, they are taking the entire prescription.

Quoting Erikwilliam (Reply 1):
has it been proven that it caused death???Some organisms may work in a different way, so....

Apparently, when you insert the drug into your vagina instead of taking it orally, you create a more... er... fertile environment for the microorganisms to grow.

Quoting 777236ER (Reply 2):
Who the hell cares what a pressure group says?

Planned Parenthood is not just a "pressure group" - it is an abortion provider. See the recent discussions about South Dakota's abortion law - Planned Parenthood runs the only abortion clinic in South Dakota. Planned Parenthood of Greater Cleveland also runs the largest abortion clinic in the Cleveland area.

Quoting Jaysit (Reply 3):
Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents

But it was, which leads me to question why, if RU-486 is "safe and effective" as prescribed and approved, did Planned Parenthood choose to use it off-label?
It seems that you may not have read the article. Here's the relevant quote:
"Meanwhile, Planned Parenthood Federation of America Inc. said it would immediately stop recommending vaginal insertion of the final course of pills. Four of the women who died, including the latest two, received the pills at Planned Parenthood-affiliated clinics, said Dr. Vanessa Cullins, the organization's vice president for medical affairs."

[Edited 2006-03-20 21:04:41]


Up, up and away!
User currently offlinePROSA From United States of America, joined Oct 2001, 5644 posts, RR: 4
Reply 10, posted (8 years 5 months 1 week 6 days 23 hours ago) and read 1418 times:

What is strange about RU-486 is that according to what I've read, using it is generally more painful and all-around unpleasant than an ordinary surgical abortion. Not to mention the fact that it fails to work properly in about 10% of the women who use it, forcing them to get surgical abortions.


"Let me think about it" = the coward's way of saying "no"
User currently offlineDougloid From , joined Dec 1969, posts, RR:
Reply 11, posted (8 years 5 months 1 week 6 days 22 hours ago) and read 1395 times:

Quoting Jaysit (Reply 5):
I'm giving you the cold, hard facts, not the lousy sound bites that you're prone to.

If you prefer to rot in your ignorance and spout inane aphorisms, however, that's your problem.

Next.

Lousy sound bites? ignorance? inane aphorisms? rot?

My, are we menstruating again? Poor dear.

There's a cure-sit on your thumb and rotate.




 bouncy   bouncy   bouncy 


User currently offlineJaysit From , joined Dec 1969, posts, RR:
Reply 12, posted (8 years 5 months 1 week 6 days 22 hours ago) and read 1378 times:

Quoting Redngold (Reply 9):
Quoting Jaysit (Reply 3):
Planned Parenthood is NOT recommending the off-label use of RU-486 after these incidents

But it was, which leads me to question why, if RU-486 is "safe and effective" as prescribed and approved, did Planned Parenthood choose to use it off-label?
It seems that you may not have read the article. Here's the relevant quote:
"Meanwhile, Planned Parenthood Federation of America Inc. said it would immediately stop recommending vaginal insertion of the final course of pills. Four of the women who died, including the latest two, received the pills at Planned Parenthood-affiliated clinics, said Dr. Vanessa Cullins, the organization's vice president for medical affairs."

It seems that you have not read it.
Or that you refuse to understand it for some reason.
Planned parenthood continued to recommend the vaginal insertion even after the first four deaths because medical reports and the FDA's own analysis showed that the deaths were not caused either by RU-486 alone, or its off-label vaginal use. Now with these two additional deaths for which medical reports are still pending, Planned Parenthood is NOT recommending the off-label use. As you yourself have noted, PP is an abortion provider among other things. It also has on its staff some of the nations's leading ob-gyns, either directly or in a consulting capacity. As I said earlier, off-label uses of drugs usually originate with physicians who in the practice of medicine discover improved conditions of use, methodologies, etc., which eventually make it to the mainstream of medicine. PP has both direct and indirect working relationships with physicians and research centers who deal with the use of the drug. In fact, they're probably the leading clearing house of all RU-486 related information.

By the way, this wait and see approach to drug use is fairly common, and as I noted before, formed much of the ever expanding use of platinum based drugs for the treatment of various cancers.

Quoting Dougloid (Reply 11):
Lousy sound bites? ignorance? inane aphorisms? rot?

My, are we menstruating again? Poor dear.

There's a cure-sit on your thumb and rotate.

Do you have anything constructive to add other than your childishness? Or do all 50+ year olds with your mindset behave like Beavis and Butthead?


User currently offlineDL021 From United States of America, joined May 2004, 11447 posts, RR: 75
Reply 13, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1362 times:
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Quoting N1120A (Reply 7):
Planned Parenthood isn't a pressure group, it is a non-profit organization that makes sure people have reliable access to birth control, abortion and sexual health testing and treatment.

They are all pressure groups to an extent. Planned Parenthood pushes an agenda, just like other advocacy groups (yeah, I know they are a 'support' group).

Quoting Jaysit (Reply 8):
biostatisticians

what'd I say about those big words?



Is my Pan Am ticket to the moon still good?
User currently offlineN1120A From United States of America, joined Dec 2003, 26444 posts, RR: 75
Reply 14, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1358 times:

Quoting DL021 (Reply 13):
They are all pressure groups to an extent. Planned Parenthood pushes an agenda, just like other advocacy groups (yeah, I know they are a 'support' group).

Planned Parenthood performs a service to the community. They are not the ones out protesting judicial appointments or blocking clinic doors.

Quoting DL021 (Reply 13):
what'd I say about those big words?

That you understand them perfectly well and know Jaysit is making an excellent point  wink 



Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
User currently offlineDL021 From United States of America, joined May 2004, 11447 posts, RR: 75
Reply 15, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1351 times:
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Quoting N1120A (Reply 14):
Planned Parenthood performs a service to the community. They are not the ones out protesting judicial appointments or blocking clinic doors.

As far as protesting judicial appointments...perhaps you ought to check out the crowds in front of the supreme court sometime, or the people screaming about the USSC
I would say that some people believe that they are performing the opposite, so it's a matter of perspective.

Quoting N1120A (Reply 14):
Quoting DL021 (Reply 13):
what'd I say about those big words?

That you understand them perfectly well and know Jaysit is making an excellent point

Well, I certainly understand his point, and I expected him to get riled about the "let's attack the drug" point of the post. I also expected some of the other posts where people aren't using their heads in this matter and are getting riled up when there's not much that's going to be done about the issue one way or the other.

I think, personally, that people abuse the drug and use it as post-coital birth control. I further believe that it is assisting in the erosion of our values in our society, as it's encouraging people to act without having to take responsibility and that's not good for any of us since more and more our society is about placing blame and trying to make someone else take responsibility for us. That's not what made us great, and it will be our societal downfall if we don't stop it. So...argue that point.



Is my Pan Am ticket to the moon still good?
User currently offlineN1120A From United States of America, joined Dec 2003, 26444 posts, RR: 75
Reply 16, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1340 times:

Quoting DL021 (Reply 15):
I think, personally, that people abuse the drug and use it as post-coital birth control

RU486 is not prescribed as post-coital birth control. The fact that it has been described as a "morning-after pill" by the media is nothing short of grossly irresponsible and inaccurate. The "morning-after pill" is Levonorgestrel (trade name Plan-B) which is a high dose of normal birth control administered up to 72 hours after sex. RU486 induces a miscarriage and is used most often in cases where women are averse or allergic to anesthetic.



Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
User currently offlineDL021 From United States of America, joined May 2004, 11447 posts, RR: 75
Reply 17, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1340 times:
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Quoting N1120A (Reply 16):
RU486 induces a miscarriage and is used most often in cases where women are averse or allergic to anesthetic.

Are you saying that it's not being used as an abortion pill by anyone?

Another point...if it induces a miscarriage...doesn't that name in and of itself indicate that it's a mis-take...or mis-hap? Just wondering if you wanted to find another term, since we're flapping about details and ignoring the big picture.



Is my Pan Am ticket to the moon still good?
User currently offlineN1120A From United States of America, joined Dec 2003, 26444 posts, RR: 75
Reply 18, posted (8 years 5 months 1 week 6 days 21 hours ago) and read 1326 times:

Quoting DL021 (Reply 17):
Are you saying that it's not being used as an abortion pill by anyone?

It is an abortion pill. It isn't the "morning-after pill" and it isn't used as "post-coital birth control".



Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
User currently offlineRedngold From United States of America, joined Mar 2000, 6907 posts, RR: 44
Reply 19, posted (8 years 5 months 1 week 6 days 20 hours ago) and read 1309 times:

Quoting Jaysit (Reply 12):
Planned parenthood continued to recommend the vaginal insertion even after the first four deaths

Why did they wait?

Quoting Jaysit (Reply 12):
FDA's own analysis showed that the deaths were not caused either by RU-486 alone, or its off-label vaginal use.

If that's the answer, then I'd like you to reread your own quote and see that you say "alone," which implies that use or misuse of RU-486 was a contributing (even if not entirely responsible) factor.
It's reasonable, then, to wonder why Planned Parenthood didn't try to eliminate as much risk as possible by going to the standard, approved method of administration, instead of continuing a potentially deadly practice.

Quoting Jaysit (Reply 12):
It also has on its staff some of the nations's leading ob-gyns, either directly or in a consulting capacity.

That doesn't mean those same doctors aren't taking unneccessary risks - especially when dealing with a group of women who are potentially more at-risk for complications and lack of informed consent.

Quoting Jaysit (Reply 12):
In fact, they're probably the leading clearing house of all RU-486 related information.

Which continues to raise the question - if they knew that vaginal insertion was not an approved method of administration, why did they recommend with the tacit knowledge that the women would be too desperate to care about the risks?

Quoting Jaysit (Reply 12):
By the way, this wait and see approach to drug use is fairly common, and as I noted before, formed much of the ever expanding use of platinum based drugs for the treatment of various cancers.

I'm sure those cancer patients are given huge amounts of information before they submit to experimentation. Did Planned Parenthood do the same? Did they tell those women that vaginal insertion was an off-label use, or did they recommend it without telling them?

Quoting N1120A (Reply 16):
RU486 induces a miscarriage and is used most often in cases where women are averse or allergic to anesthetic.

Miscarriages have some of the same risks as surgical abortion. A woman who is pregnant and showing signs of miscarriage is likely to be hospitalized if she wants to be pregnant; these women who are given RU-486 are sent home and generally not monitored except for when they receive their medication. Is it worth the risk?



Up, up and away!
User currently offlineAerorobNZ From Rwanda, joined Feb 2001, 7184 posts, RR: 13
Reply 20, posted (8 years 5 months 1 week 6 days 20 hours ago) and read 1295 times:

Who cares, I'm not ever going to be using the drug...

User currently offlineDougloid From , joined Dec 1969, posts, RR:
Reply 21, posted (8 years 5 months 1 week 6 days 19 hours ago) and read 1279 times:

Quoting Jaysit (Reply 12):
Quoting Dougloid (Reply 11):
Lousy sound bites? ignorance? inane aphorisms? rot?

My, are we menstruating again? Poor dear.

There's a cure-sit on your thumb and rotate.

Do you have anything constructive to add other than your childishness? Or do all 50+ year olds with your mindset behave like Beavis and Butthead?

The only person here acting like a jerk here is you.

I suggested there are other opinions than the ones that folks in DC have and that you ought to get out more and I got slagged by you. I responded at your level.

So who's acting like Beavis and Butthead? Why, the person who started it, and that's you.

Personally, I'm relieved. If you represent the caliber of people in DC with a law degree, the rest of us have nothing to worry about here in the rest of the country. You're all idle fools.


User currently offlineN1120A From United States of America, joined Dec 2003, 26444 posts, RR: 75
Reply 22, posted (8 years 5 months 1 week 6 days 13 hours ago) and read 1246 times:

Quoting Redngold (Reply 19):
Miscarriages have some of the same risks as surgical abortion

Surgical abortions are as safe, if not safer than taking RU486. It is for use as an alternative where surgery is a less safe option



Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
User currently offlineDL021 From United States of America, joined May 2004, 11447 posts, RR: 75
Reply 23, posted (8 years 5 months 1 week 6 days 5 hours ago) and read 1215 times:
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Quoting N1120A (Reply 18):
It is an abortion pill. It isn't the "morning-after pill" and it isn't used as "post-coital birth control".

ok...so you're arguing semantics instead of the actual point I made and asked for argument?

fine....here's your line... "it is an abortion pill" so that means it's not taken the morning before you have sex and get pregnant. It also means that it's used to control the birth process of the foetus, which makes it birth control and it's applied post-coital. Hence...post-coital birth control (rather than wearing a condom, or using other proven birth control methods).

So....now that we've proven that it most certainly is a method for post-coital birth control, so why don't we discuss the fact that I believe, firmly, that such systems being available make it easier for people to avoid responsibility for their actions which hurts society by making people feel that they can do whatever they want without consequences.......and that's how the Romans fell.



Is my Pan Am ticket to the moon still good?
User currently offlineMattCLE From , joined Dec 1969, posts, RR:
Reply 24, posted (8 years 5 months 1 week 6 days 4 hours ago) and read 1208 times:

Quoting DL021 (Reply 23):
so why don't we discuss the fact that I believe, firmly, that such systems being available make it easier for people to avoid responsibility for their actions which hurts society by making people feel that they can do whatever they want without consequences.......and that's how the Romans fell.

I am all for personal responsibility but as a society I think we need to focus more on the war in Iraq, our environment, etc. IMO I think these things are a greater threat to our safety/society than what some chick is sticking up her vagina.

IMO we live in a society where it seems people have to die before we begin to look at making changes (i.e. Airplane/Airport security, Space Flight, Pills leading people to suicide or death, etc.)

Ultimately I think this RU-486 debate boils down to whether or not you are pro-life or pro-choice. We can argue all we want on how the pill is used, but I am pretty certain people already have a set opinion on what they think of the pill, deaths or no deaths.


25 PROSA : Women who receive RU-486 have to wait several hours in the provider's office to make sure it works. It's therefore better suited to being dispensed i
26 DL021 : I would have to agree, hence my earlier point about the pointlessness of the discussion. However some people decided to pick nits and that led me to
27 MattCLE : I mentioned what I did because it seems we are discussing here why we are allowing women to use the pill the way they do, even though people have die
28 Luv2fly : Well said.
29 Dvk : One thing needs to be clarified here. It is not the RU 486 that has been used off label. It is the misoprostol used along with RU 486 that has been us
30 DL021 : That's very same exercise in semantics is the one that allows people to think they are discussing choosing to exercise their God-given freedoms, rath
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