Aces High Bulletin Board
General Forums => The O' Club => Topic started by: -MZ- on May 11, 2004, 05:03:22 PM
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Anyone else remember the debate where Bush promised not to block RU-486?
LA TIMES EDITORIAL
Politics of Contraception
Election-year concerns trump science in FDA decision to keep "morning-after" pill off the shelves. Many women will suffer because of this misguided move.
More than 70 of the nation's leading medical and public health groups backed a proposal to let women buy emergency contraception without a prescription.
The U.S. Food and Drug Administration's own advisory panel, after reviewing 40 studies and 15,000 pages of data, overwhelming recommended over-the-counter status for the so-called morning-after pill.
Use of this pill would cut the number of abortions in this country — a goal President Bush ardently embraces — and millions of women who have used it by prescription since 1999 have found this drug to be safe and effective in blocking unwanted pregnancies.
And yet it's an election year, and many of Bush's supporters insist that broader availability of the pill would encourage promiscuity and unsafe sex.
So when FDA leaders overruled their own scientific advisors to reject over-the-counter sales Thursday, politics once again trumped science, despite their avowals to the contrary. The decision echoes this administration's big-footing of scientific evidence on stem cell research and environmentally safe levels of mercury and arsenic.
The agency has, however, left open a path that would let women eventually obtain this drug more easily — after the November election — and the pill's maker should pursue that opportunity.
In a letter to manufacturer Barr Laboratories, the FDA said the company had failed to prove that girls younger than 16 could safely use the drug, which it markets as Plan B, without guidance from a doctor or nurse. Until Barr can satisfy the agency that Plan B is safe for teenagers or present a plan for over-the-counter sales to older women and more restricted sales to 14- to 16-year-olds, the FDA has blocked all over-the-counter sales.
Barr says it will pursue these options, but even if it acts quickly, approval probably won't come for a year, long after November's votes are counted.
Emergency contraceptives contain a concentrated dose of the hormones found in birth control pills. Taken within 72 hours of unprotected sex, the pill prevents pregnancy by delaying ovulation, blocking fertilization and inhibiting uterine implantation. But the drug is more effective if it is taken within 24 hours rather than 72 hours.
That's why California and four other states permit pharmacists to dispense it without a prescription if women ask.
But surveys show that few pharmacies in California stock the pill and few women know to ask for it. Over-the-counter sales would give far more women access to this drug, especially on holidays and weekends. For now, however, FDA leaders have left a lot of women in a difficult, and unnecessary, spot.
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Just more republican big brother antics. They claim to be for personal freedom, but only if it meets the criteria of the Christian Coalition.
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Yeah, it HAS to be politics, it COULDN'T be incomplete research data submitted to the FDA now could it?
From the FDA website:
FDA News
FOR IMMEDIATE RELEASE
P04-53
May 7, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval
The Food and Drug Administration (FDA) today acknowledged that it has issued a “Not Approvable” letter to the sponsor of an application to make the Plan B emergency contraception product available without a prescription. In its letter to the sponsor, FDA outlined the additional information that would be required to gain approval to market Plan B over-the-counter.
FDA based its action primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor’s application contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old.
FDA’s letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician. The letter also points out that the sponsor’s March 11th amendment of its application to allow marketing of Plan B by prescription only to young women under 16 years of age was not complete. As a result, the agency was unable to do a complete review on that amendment during this review cycle.
Dr. Steven Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER), said “Although we did not have sufficient data to approve this application now, I will be working toward the expeditious evaluation of Barr's response to the Not Approvable letter. If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States. Wide availability of safe and effective contraceptives is important to public health. I look forward to supporting CDER's important continued role in ensuring improved availability of these products."
Although U.S. law prohibits FDA from discussing pending applications because they contain commercial confidential information, in this instance the sponsor of Plan B, Barr Research, has allowed FDA to comment in general terms on the status of Barr’s application to make Plan B available as an OTC product, and on the agency’s action.
The official rejection letter from the FDA:
Rejection Letter in PDF format (http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf)
Sounds like to me all they have to do is complete the research and all will be approved.
Yeah, again it's Bush's fault.
:rolleyes:
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LOL diablo,
WOW I just love this whole attitude "fix everything w/ a pill". I dont need to work out....I can sit on the couch eating potato chips while masturbating and not gain a pound. I can go out and have as much unsafe sex as I want and that whole little pregnancy problem just goes away.
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So far as I am concerned, if it is completely safe or as safe as any other over the counter drug then it should be approved.
Weren't there some really bad effects from the drug reported tho?
If it is a "moral" issue then it should still be sold over the counter and each person can decide his own "moral" obligation.
Make sure it's safe and then market it. That's all there seems to be to it.
lazs
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Or just let the people consuming it decide for themselves whether the risks are worth the benefits in their individual situation.
Why should an adult woman care if it hasn't been proven safe in minors? Research shows it's safe for her, so she should have the option of taking it.
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Severe side effects and risk. The issue for otc is kids, in my opinion, that are too stupid to assess and assume those risks.
Morally, I think it is the best idea since, well, birth control pills.
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Originally posted by Tarmac
Why should an adult woman care if it hasn't been proven safe in minors? Research shows it's safe for her, so she should have the option of taking it.
Agreed. I have no problem with that. But I can't fault the FDA for wanting more research before making OTC and available to women of all ages. There are plenty of mom's out there who will get these for their daughters if lil "Britney" pouts enough. Think about the litigation on that; if lil "Britney" has an allergic reaction to the pills and goes comatose...yeah, I can see the lawyers lining up for that one because not enough research was done by the sponsor of the pill.
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Has it really been shown to be "over the counter safe" for women over 16?
Over the counter is pretty loose... the ephedrin thing was "over the counter"... How long before it was pulled?
What is wrong with getting a perscription for it untill it is proven safe?
I don't see anyone trying to stop people from using it on moral grounds here.
Hard to believe that something that radical could be that safe that it could be sold to anyone regardless of their physical conditon or pre-existing conditions.
lazs
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Lizking, kinda agree with ya there. I don't personally have any religious convictions or moral aversion to abortion, so the only concern I have over this drug would be it's accessibility to minors.
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Originally posted by midnight Target
Just more republican big brother antics. They claim to be for personal freedom, but only if it meets the criteria of the Christian Coalition.
It can't be true. Only the democrats make laws protecting us from ourselves. ;)
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Or just let the people consuming it decide for themselves whether the risks are worth the benefits in their individual situation.
I'm sure there a gaggle of lawyers that would just love that.
Waaaaaaaaaaaaa!!!! It made me sick! I'm an instant Lotto winner.
Waaaaaaaa!!! It made me sick! How could Bush allow this on the market.
Waaaaaaaaa!!! I'm a fat slob! It's McDonald fault.
Shall I go on?
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I think I already did Gyro. LOL.
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lol, and here I am thinking they approve everything. You see ads for all kinds of pills on TV. Common side effects are diaria, vomiting, severe stomache cramps, loss of blood circulation, loss off vision, possible amputation of limbs(or extra limbs growing), migrain headaches, and liberal thinking.
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^^^^^^^
You’re right, please feel free to beta test them for me. Or would that be Alpha? Could be worth a future guest star slot on the Ricki Lake show. :)
I forgot one.
Waaaaaaaaaaa!!!! My reproductive rights are being denied!!! My ovaries are mush!!!
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you mean abortion in a bottle?
they'll be plenty of that in hell for those who desire it ...
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they'll be plenty of that in hell for those who desire it .
(http://facweb.stvincent.edu/academics/english/el240/Images/sinnersinhandsb.jpg)
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I dunno about all this stuff but one thing's fer sure...
(http://www.stbernardsports.com/sbssports/assets/product_images/PAOHADBBDLLGDNPLt.jpg) <--- sales of these things are gonna go through the roof this year.
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Originally posted by VOR
(http://facweb.stvincent.edu/academics/english/el240/Images/sinnersinhandsb.jpg)
not angry, just
you reap what you sow - ying & yang
anyone think abortion of any sort is GOOD karma?
sry to pop ur bubble, it ain't nothing but a bunch of big bad negative energy - ready to bounce back in ur face when you least expect it ...
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Wow.
Deflect the subject of this thread (Bush is a liar) and we somehow wind up on abortion.
The pill in question is a contraceptive, not an abortion inducer. It prevents conception which last I new was when life started, according to some. Without conception you have no beginning of life therefore the pill is no different than a condom or any other oral contraceptive.
But it's all Bush's fault that it didn't get FDA approval.
Damn right wing nut cases.
:rolleyes:
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Originally posted by DiabloTX
Wow.
Deflect the subject of this thread (Bush is a liar) and we somehow wind up on abortion.
The pill in question is a contraceptive, not an abortion inducer. It prevents conception which last I new was when life started, according to some. Without conception you have no beginning of life therefore the pill is no different than a condom or any other oral contraceptive.
But it's all Bush's fault that it didn't get FDA approval.
Damn right wing nut cases.
:rolleyes:
WHAT?!? RU486 causes a spontanious abortion- that's why it's called the "morning after" pill. Sheeesh man, would you put a condom on AFTER sex? :rolleyes:
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Originally posted by Nash
I dunno about all this stuff but one thing's fer sure...
(http://www.stbernardsports.com/sbssports/assets/product_images/PAOHADBBDLLGDNPLt.jpg) <--- sales of these things are gonna go through the roof this year.
...but if you wear them, your penny will drop off. ;)
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From http://www.contraception.net
Quote:
What types of Emergency Contraception are available?
The "Morning After" Pill
What is it?
The "morning after" pill is a combined oral contraceptive which contains a high dose of the female hormones, estrogen and progestin. The morning after pill actually consists of four combined oral contraceptives tablets. You take two of the tablets with water immediately and two tablets 12 hours later.
How does it work?
The "morning after" pill should be taken as soon as possible after unprotected sex. Ideally, you should take the pills within 24 hours of having unprotected intercourse, but it can work up to 72 hours later. The morning after pill works in the same way that OCs do - they prevent a pregnancy from starting by preventing ovulation.
How effective is it?
Emergency contraception is very effective when taken as directed. The sooner you take it, the more effective it is. Ideally, you should try to take the "morning after" pill 24 hours after unprotected sex and no later than 72 hours. If you are already pregnant, however, the morning after pill will not work. The morning after pill will not hurt the fetus.
Are there side effects?
Nausea and vomiting are the most common side effects. These side effects can persist from a few hours to a few days. Serious side effects such as blood clots, heart attack and stroke are extremely rare.
If you want to put on a condom afterwards thats up to you.
:rolleyes:
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justify it in ur mind and the mind of ur irresponsible female partner(s) anyway you want - still big bad karma bud
(http://cagle.slate.msn.com/news/abortion/aborgifs4/wells930.gif)
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Hmm... Gyro hit it exactly... we have a socialist democrat installed judge country and you blame Bush because the the FDA is afraid of being sued?
Now who do you think endorses sueing over bussines blunders more... democrats or republicans?
You made your bed now lie in it. You wanted mommy to protect you and that is what you got... can't go after the big bad tobacco people and the mean ol gun manufacturers and mcdonalds and leave out the pill guys.
lazs
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Well, drugs like RU-486 and Viagra are big money makers for Drug companies, and prolly should take precedence over any type of drug that might actually save lives.
I mean hell, it's not important that old folks on medicare can't afford Diabetes meds.
What's important is they can pop a Viagra, git dere freak on, then pop a morning after pill.
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I always thought that the name RU-486 was kind of ironic in relation to what it does. The name itself asks the question:
Are You For 86? (86, of course, being slang for getting kicked/thrown out a bar, for example. You draw the analogy...)
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Aren't condoms otc? How many sperm have died needlessly in a little rubber hell hole?
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Originally posted by Eagler
justify it in ur mind and the mind of ur irresponsible female partner(s) anyway you want - still big bad karma bud
Pathetic, people preaching condescendingly to others who didn´t fall for the same BS.
I don´t have anything against god, it´s his moronic fanclub that annoys the hell out of me
.
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Originally posted by Thud
Pathetic, people preaching condescendingly to others who didn´t fall for the same BS.
.
I aint preaching jack, its a fact
(http://www.cbctrust.com/ru486pro.GIF)
note* = EMBRYO
just another selfish action in a world filled with me-me first ppl
it really has nothing to do with God, it is about right and wrong, Light or Darkness, being responsible or not..
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Originally posted by midnight Target
Just more republican big brother antics. They claim to be for personal freedom, but only if it meets the criteria of the Christian Coalition.
Ahhhh.....not true my left coast friend:)
Bush never supported the morning after pill, but rather stated clearly his intention to not allow it's sanctioning.
Approval of RU-486 is wrong
The FDA approved yesterday the abortion pill RU-486, but leaders on both sides of the abortion issue say debate over the pill will continue. The FDA approved the drug under a regulation that gives the agency more leeway to impose tighter restrictions or even take it off the market.“The FDA’s decision to approve the abortion pill RU-486 is wrong,” Bush said in a statement. “As president, I will work to build a culture that respects life.”
Source: Rita Rubin, USA Today, p. 1A Sep 29, 2000
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Hhahhhahahhahahha :)
Woman cuts leg shaving; wins lawsuit
http://www.msnbc.msn.com/id/4962543/
Bush at fault.
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I've changed my stance on the abortion issue. I firmly believe it should be legal, promoted and encouraged. There'd be far fewer idiots in the world.
....lets ban vaccines too, the weak are surviving too much.
T.
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Forgive me for butting in here, but you guys seems to be confusing the morning after pill with the abortion pill.
The morning after pill is taken within 72 hours of unprotected sex and prevents pregnancy by changing the chemical content of the lining of the uterus so the egg cannot attach itself. Actually the morning after pill is a high dose of birth control pills.
RU-486 as Eagler just pointed out actually takes an already fertilized egg that's attached to the lining of the uterus and chemically changes the lining to make the egg and lining shed itself causing an abortion. From what I remember doctor's only prescribe it in the first trimester of pregnancy, but I could be wrong. The problem with prescribing it over the counter is that there has always been a followup appointment after taking the pills to make sure that the pregnancy has been sucessfully aborted. I can see making sure the morning after pill is available otc, but not RU-486.
Sorry, I was in college not too long ago and because of stupid behavior on my part I did a lot of research on these topics.
You know, now that I think about it, since birth control pills aren't otc because of complications and side affects, I don't think either of these should be as well. I think the first logical step in pregnancy/antipregnancy drugs would be to make a better birthcontrol pill with less side affects that could be approved for over the counter use....but I'm forgetting that men run the drug companies; a better birthcontrol pill is about as likely as a male birthcontrol pill. :) I'll save that rant for another day.
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We can't be bothered with actually understanding the function of wombs we want to control and the myriad of drugs to do so. ;)
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(http://zipper.netfirms.com/images/gold-zipper.GIF)
no side effects cept for a couple of big blue ones :)
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Originally posted by Eagler
(http://zipper.netfirms.com/images/gold-zipper.GIF)
no side effects cept for a couple of big blue ones :)
Hehehehe...just watch out for the 'frank and beans'.
:D
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So looks like MG has a new handle, and after being banned on AGW, he has decided to try his luck here again.
dago
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I still don't get why some men feel they have a right to even comment on a woman's choice of birth control, sound so middle-eastern to me.
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Originally posted by Eagler
justify it in ur mind and the mind of ur irresponsible female partner(s) anyway you want
Of course, men are never responsible...for anything...:rolleyes:
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Originally posted by Torque
I still don't get why some men feel they have a right to even comment on a woman's choice of birth control, sound so middle-eastern to me.
We should ban viagara while we're at it. If you can't get it up, better off then to not have weak-limped male offspring polluting the gene pool.
They were just irresponsible in their youth, all the junk food, budweiser, and marlboro lights from their frat-boy parties porked their circulation...now live with it :lol
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I still don't get why some men feel they have a right to even comment on a woman's choice of birth control, sound so middle-eastern to me.
STONE HIM!!!
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Originally posted by Tarmac
Or just let the people consuming it decide for themselves whether the risks are worth the benefits in their individual situation.
Why should an adult woman care if it hasn't been proven safe in minors? Research shows it's safe for her, so she should have the option of taking it.
Because if its over the counter whats to stop a very young girl from buying and using it?
Best to let the DR's work this one out.
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Originally posted by Torque
I still don't get why some men feel they have a right to even comment on a woman's choice of birth control, sound so middle-eastern to me.
Uh maybe because it takes a man and a woman to make babies.
Both partys should take a responsable role if there going to do the wild thang.
Like I told my nephew If ya wanna play be ready to PAY!
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Originally posted by Athena3
a better birthcontrol pill is about as likely as a male birthcontrol pill. :) I'll save that rant for another day. [/B]
Rant on you have a very valid point there!
Why should all the resposability be on the woman for birth control?
Grow up be men take responsability for your actions and for gods sake if she does get pregnant be there for her.
I have seen too many dudes run like hell when there girlfriends get pregnant.
And to me that just makes them punks.
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Originally posted by Athena3
but I'm forgetting that men run the drug companies; a better birthcontrol pill is about as likely as a male birthcontrol pill. :) I'll save that rant for another day.
http://www.cnn.com/2003/HEALTH/10/06/male.pill/ (http://)
She added that although the Family Planning Association welcomed the news, she anticipated that it would be five to 10 years before a male contraceptive was available commercially.
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I don't know who you're preaching to.
We're Aces High flight simmers.
Unless we're married or we've managed to fluke out, we generally don't have sex.
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Originally posted by Nash
I don't know who you're preaching to.
We're Aces High flight simmers.
Unless we're married or we've managed to fluke out, we generally don't have sex.
LOL good point:D
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Oh boy...literally. The fun thing to think about is how much more delicate and complicated the female reproductive system is. Turns out a lot of doctors are saying that hormonal birthcontrol is bad for women in the long run; anything over six years can jeoprodize their health. The bottom line is: why has it taken this long to do these studies for males and develop these drugs? We've had female birthcontrol pills since what, the 60s? Here it is 2004 and we still don't have any birthcontrol options for males other than condoms. I hate to sound cynical but I know of so many cases where a woman would stop taking her medication just so she could have a baby and lock a male into a relationship. I think men should be able to protect themselves against that kind of behavior.
And I also read something interesting for all you fathers: disposable diapers raise the temperature in the genital areas of male babies to the point where it can cause a decrease in the sperm production that baby will be able to have as an adult, I think because of underdevelopement or something, it's been a while since I read the article. So don't blame infertility all on junk food and beer, blame it on convience.
Geesh, this is one conversation I never thought I'd have online.
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Originally posted by Athena3
And I also read something interesting for all you fathers: disposable diapers raise the temperature in the genital areas of male babies to the point where it can cause a decrease in the sperm production that baby will be able to have as an adult, I think because of underdevelopement or something, it's been a while since I read the article. So don't blame infertility all on junk food and beer, blame it on convience.
I'm not sure the census numbers support this idea. I'm guessing that the people that use cloth diapers anymore are few and far between and this has been the case for decades.
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Well, the thing is, you can have a low sperm count and still conceive, right? I meant we're talking about, what, millions of sperm to start with? I believe the article said that the samples that they had been taking over the years show a steady decrease in sperm levels, the decrease being more marked in the years since disposable diapers were used, and they believed, in part, it was contributed to this temperature increase. As I said, it's been a while since I read the article, I might be forgetting stuff. It was in some scientific journal my college roomate read (she's in genetics now turning mice different colors). It'd be interesting to compare conception rates around 1800 or even 1900 vs today. Think about how many people go to fertility specialists every year. Granted, some of that is women putting off having kids until their 40s, but still one wonders. Sorry, I find this stuff fascinating for some reason.
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No worries. I could very well be full of hooey.
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Nah, more likely to be me disremembering. It was college after all, I was probably tipsy, instant messanging frantically or distracted by a male at the time (pity my poor, poor roomate). :)
*note to self: distract Mj from reading this thread*