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View Poll Results: How would you like to see the morning after pill RU-486 regulated in the US?
Available over the counter to all who want it
19
48.72%
Available by prescription only
5
12.82%
Available by prescription only with parental consent required for people under 18 years of age
I was wrong, it does cause an abortion, now I understand why the pro life folks hate it.
Quote:
Mifepristone (RU-486): Myths and Facts
December 29, 2000
MYTH: Mifepristone (commonly known as RU-486) is a dangerous drug that will harm women.FACT: Mifepristone has been proven to be a safe and effective drug.
Mifepristone has been approved for use as a safe and effective abortifacient in 19 countries. The earliest approvals were announced in France and China in 1988, the United Kingdom in 1991, and Sweden in 1992.
Since 1989, more than half a million women in Europe alone have used mifepristone as an early and safe option for ending an unwanted pregnancy.
U.S. clinical trials found that mifepristone, followed two days later by misoprostol (a drug used to stimulate uterine contractions), was a safe and effective abortifacient. For pregnancies of 49 days’ or less duration, the drug combination successfully ended pregnancies in 92.1% of the participating patients. In the remaining cases, women experienced continuing pregnancies, incomplete abortions, or other complications and received safe and common first-trimester surgical abortions. Overall, only 0.7% of all participating patients were hospitalized after taking the drugs. Only about half of these hospitalizations were related to the drugs; others were due to unrelated events such as automobile accidents and infectious diseases. There were no deaths reported.
U.S. clinical trials confirmed the findings of studies conducted in France in which thousands of women took mifepristone in combination with misoprostol as an early-option abortion method. The French trials showed the drug combination to be 95.5% effective for ending pregnancies of up to 49 days’ gestation.
MYTH: The FDA rushed to approve mifepristone.FACT: The FDA conducted a rigorous and lengthy review of the drug.
The Population Council submitted its application for mifepristone's approval to the FDA in March 1996, following clinical trials that began in 1983. The FDA issued final approval of mifepristone in September 2000.
The FDA approved mifepristone after carefully reviewing three complete phases of clinical trials–the standard review process–that took place in the U.S. and France and involved thousands of women. Based on the data from these studies, the FDA concluded that the drug is safe and effective.
According to the FDA, the average review time for an "innovative" new drug–unlike mifepristone, which has been extensively tested–is 6 months or less. The agency took considerably more time in approving mifepristone.
MYTH: With mifepristone available, more women will have abortions.FACT: In countries where mifepristone has been available for many years, the overall abortion rate has not increased. Instead more women have had earlier and, therefore, safer abortions.
Since the drug became available in France in 1989 the total number of abortions has remained constant.
There is no evidence that making medical abortions available to women affects the overall abortion rate. In the 1990s, physicians in the U.S. began to use another safe and effective regime for early medical abortions: methotrexate-misoprostol abortions. The Centers for Disease Control report that in 1997 (the most recent data available), the number of abortions in the U.S. declined to its lowest level since 1978. Moreover, of those women having abortions between 1992 and 1997, more had them in the early weeks of pregnancy.
MYTH: It is dangerous and highly unusual for doctors to use drugs "off-label."FACT: Evidence-based alternative uses for drugs are standard medical procedure.
A long-standing FDA policy permits medical providers to prescribe medications "off-label," meaning for uses other than those for which a drug has been specifically approved.
According to the American Medical Association, up to 60% of prescription drugs in the United States are prescribed for off-label purposes.
The FDA-approved mifepristone-misoprostol regime calls for doctors to prescribe misoprostol off-label.
Recent studies suggest that mifepristone may be effective in treating fibroid tumors, endometriosis, Cushing’s Syndrome, meningiomas, and some types of breast cancer, among other diseases and conditions. It has also been shown to be a safe and effective "morning-after" pill. All of these uses would be off-label.
MYTH: Misoprostol, the second drug in the FDA-approved protocol, is unsafe for use in pregnant women.FACT: For almost a decade, ob/gyns have used misoprostol safely and effectively in abortions, to assist women in labor, and to treat postpartum complications.
Misoprostol, an anti-ulcer medication, has been widely used off-label in obstetrics and gynecology for almost a decade to ripen the cervix (in abortions and in childbirth), induce labor, and treat serious postpartum bleeding.
Extensive clinical trials have indicated that misoprostol is more effective than and, when used appropriately, as safe as other drugs commonly used to ripen the cervix or induce labor.
MYTH: The Chinese company manufacturing mifepristone for distribution in the U.S. does not meet FDA standards.FACT: The FDA thoroughly inspected the Chinese factory and determined that the plant fully met FDA standards for international drug distribution.
The Chinese plant contracted to produce mifepristone for distribution in the United States passed a thorough FDA inspection in July 1999.
In the past three years, the manufacturer upgraded its equipment and retrained its staff to meet international standards.
I'm waiting for an explanationas to how the ACLU is pro abortion ?
Wonderful misquote and sensationalism. I never suggested anysuch thing. What I did suggest is that your article tells us NOTHING about that data, nothing. Without context it is meaning less.
What was the total population of the study and over what period ?
As an example wre there 5 deaths in a study population of 10 over a period or 2 weeks. Conversely was this 5 deaths over a period of 10 years in a population of 10 million.
In the first case there would be sifnificant cause for concern, in the second, it statisticly insignificant. Does that mean it is insignificant to the families, no, for you to suggest such is both insulting and ridiculous.
In a large enough population you will find problems with anything. Also we have no information [from your link] to determine if the problems are even related to the drug in question.
If it is safe and effective then it should be available, if not it shouldn't simple isn't it. But we need to use science to make that determination.
I have no personal axe to grind here at all except objecting to the involvement of religion into what should be a scientific determination. This is the mandate of the FDA.
I wasn't aware that in order to post a link related to a topic that the refered to article had to meet an criteria of scientific study and statistical analysis. In fact, I am certain that I have seen other links/articles posted from time to time the did not meet your expected standards.
Get real, nidan. It's not about statistical veracity, it is about your opinion differing from mine. You want to provide the scientific studies, go ahead. But to state that the FDA approves, that makes it right carries no weight with me.
__________________
"Get your facts first, and then you can distort them as much as you please."
-Samuel Langhorne Clemens
What I mean is that the FDA is supposed to approve drugs based on scientific criteria, this is it's mandate from congress.
The Bush administration has been injecting their political/religious views into the process.
The FDA is supposed to determine if a drug is both safe and effective for the requested use. That's it, nothing more.
The pro life movement objects to this drug on religious grounds as it makes almost impossible for them to protest it's use of control it in any way. It effectivly makes most of their protest mechanism absolete.
Conversely, it would also effectivly eliminate one of their major talking points. This is the 'Abortion Industry'. They try to make it sound like abortion is a commerical operation, well this would remove most of that from the equation. Why aren't they/you glad that this will put many planned paeranthood clinics out of business ?
Location: on the run from johnny law... ain't no trip to cleveland
Posts: 9,352
A$FN: 1,000
Quote:
Originally Posted by nidan
I havn't heard of anything but it is impossible to prove a negative.
If 'proof' were required then asprin would not be available. The standard is doing enough studies to determine with a reasonable likleyhood that it has no problems.
Unfortunalty it is NOT POSSIBLE to prove it, so we end up with Viox etc. No amount of testing can ever prove a negative
whoa whoa whoa, calm down, i was just asking! you haven't heard of any. ok, that's what i wanted to know.
The point is that the links you are posting are put up by the Anti Abortion lobby.
So their view on the material is slanted. They will be quick to find information that supports them and will never post information that detracts from their agenda.
I don't have an agenda, I just want the FDA to do it's job without religious interferance.
It's just as soon as somebody says it not proven safe they jump all over the statement without underatnding the concept that proving a negative is impossible.
Location: on the run from johnny law... ain't no trip to cleveland
Posts: 9,352
A$FN: 1,000
Quote:
Originally Posted by nidan
It's ok, I know that.
It's just as soon as somebody says it not proven safe they jump all over the statement without underatnding the concept that proving a negative is impossible.
don't worry, i get that concept. (it's a point i'm trying to make in another thread, in fact!)
Conversely, it would also effectivly eliminate one of their major talking points. This is the 'Abortion Industry'. They try to make it sound like abortion is a commerical operation, well this would remove most of that from the equation. Why aren't they/you glad that this will put many planned paeranthood clinics out of business ?
RU-486 causes the death of a human life. Whether an abortion clinic doctor or a chemical taken by the mother of the child doing the killing matters not. In either instance the event is tragic.
However on topic...
The current "push" is to make RU-486 available, basically over the counter. My position is that it is not a "safe" drug, comparable to asprin, pepcid, benedryl, etc. If it is taken (and I don't think it should be), it should be taken under the supervision of and adminisitered by a medical doctor.
__________________
"Get your facts first, and then you can distort them as much as you please."
-Samuel Langhorne Clemens
My feeling is that is what the FDA is for and it should be based on science. I am neither pro or anti this.
From a pissing of the anti abortion crowd it's a wash, as going to a doctor is [in most cases] not an issue. There are some places in rural arizona that is an issue though.
If you look at what really irks me you will see a common thread. It's the attempts to the scientific process by religious pressure groups.
I'm not anti religion, it's just that religion and science are different subjects and to many folks to day want to control scientific thought and ideas such that it conforms to their idea of religion.
where is the "available over the counter to adult women" option.
I didn't include that as an option because pharmacists would then be required to determine the age of customers which would be opening a whole new can of worms.
Location: on the run from johnny law... ain't no trip to cleveland
Posts: 9,352
A$FN: 1,000
Quote:
Originally Posted by Rivercard
I didn't include that as an option because pharmacists would then be required to determine the age of customers which would be opening a whole new can of worms.
it could *beep* at the checkout and require an id, like alcohol, cigarettes or diet pills...
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