Title: Plan B
Description: The Debate Over
Deltasix - November 28, 2005 02:38 AM (GMT)
| QUOTE (CBS) |
When the “morning after pill,” also known as “Plan B,” was put on the market in 1999, it was described as an emergency contraceptive that prevents a pregnancy in cases of rape or accidents like condom breaks.
It is only available by prescription. But because women need to take it within 72 hours, the drug's manufacturer applied to the Food and Drug Administration two years ago for permission to sell Plan B over the counter.
The drug is considered totally safe, so the request was seen as a slam dunk. But then Plan B became the target of anti-abortion rights groups, and part of the wider controversy over whether religious beliefs are encroaching on scientific decision-making.
60 Minutes Correspondent Lesley Stahl reports.
Until last August, Dr. Susan Wood headed the FDA’s Office of Women’s Health and was one of the scientists inside the agency arguing that Plan B should be available without a prescription. “If it's safe, and it is, and effective, it's more effective the quicker you have it. This is why it needs to be over-the-counter,” she says.
“If you need it on Saturday morning, Monday morning is too late. Getting to a physician to get a prescription, getting that prescription to a pharmacy and getting it filled takes time, as we all know. Then what are you going to do?” says Wood.
That’s a question that a woman named Evelyn faced last year, when she was raped at a New York nightclub.
Evelyn, age 22 at the time, was rushed to St. Vincent’s hospital, the nearest emergency room.
She says the hospital did not offer her an emergency contraceptive.
“It was something that they were supposed to offer,” says Evelyn’s mother, Sandi. “In the situation as my daughter’s, as Evelyn’s situation, they were supposed to offer, you know, and let the person make the decision as to whether or not they wanted it. I didn’t know that it was optional.”
Sandi says she knew about a New York law that says all hospitals must offer rape victims emergency contraception like Plan B.
Sandi called the nurse who had treated Evelyn at St. Vincent’s. “I said, ‘Why did you not give it to her?’ And she very rudely said to me, ‘Well, we're a Catholic hospital. We don't do birth control.’ At which point, I told them what they could do with being a Catholic hospital and their views on birth control — I'd rather not say that on the air,” she recalls. “I was absolutely livid.”
Because of Evelyn's case, St. Vincent’s is under investigation by the state of New York. The hospital told 60 Minutes it is now complying with the law.
Evelyn finally got a prescription for Plan B, and took it 10 hours after the rape. Had she not gotten Plan B and had gotten pregnant, Evelyn says she would have had an abortion. “I'm glad that that didn't have to happen, I never had to experience that," she says.
The Catholic Church opposes Plan B not just because it’s birth control, but because it considers use of Plan B to be, in Cardinal Egan of New York’s words, “a chemical abortion.”........
Full Report |
Your thoughts? If you have the time, read the full article.
psycholopher - November 28, 2005 06:11 AM (GMT)
I was just reading an article about aberrations in how Plan B was rejected in its application to receive "over the counter" status. From a medical/political standpoint, I think that it might as well be allowed to be made available over the counter. It is already legal. It is already approved of by the FDA. And it only works when taken in a specific amount of time.
However, I do not disagree with the Catholic Church's position that it is "a chemical abortion." The Church is being consistent here: Life starts at conception. It's the same reason that it opposes "regular" abortions and the destruction of embryos for stem-cells. It's being logically consistent and faithful to the belief that a human life begins at conception.
Deltasix - November 28, 2005 01:39 PM (GMT)
Doesn't Plan B prevent conception?
Anyways, yeah, the only job of the FDA is to decide if a drug is safe enough to be made an over the counter drug here. It isn't it's role to choose if it is a "moral" thing or not. The idea that it increases sexual activity among teens or that it cuts out the doctor had all been refuted. The fact that you have to me 16 is a fine stipulation, I have no problem with that at all.
Even in it's orginal form, the FDA had no problem (voting 26-4[or somthing like that]) with making it over the counter drug.
I don't understand why it was vetoed for that in the first place.
Boru - November 29, 2005 05:36 AM (GMT)
I agree with Psych on this one.
It's a chemical abortifacant, which is HOW it prevents conception if conception has already occured.
Honestly the Catholic church doesn't like any form of contraception so eveen if you view it as such why would you be suprised by their stance against it?
That being said since it is FDA approved I'm also fine with it being available over the counter. I just disagree with it's method of being a contraceptive.
Fable of Flame - November 29, 2005 11:46 PM (GMT)
I think and this is only my opinion so feel free to shoot me down but i think that the morning after pill should be made over the counter because in taking it your not killing a fetus only stopping one from being conceived its just like birth control except it comes after sex instead of before what the pill does in theory is block the eggs from fertilization this is possible because it takes 72 hours for the sperm to reach the eggs. Therefore as I have already said your not kill a baby only preventing one.
"Short Sweet and to the Point" Thats Me
Deltasix - December 4, 2005 03:22 AM (GMT)
The way that Fable of Flame put it, how it works, is basiclly how I understand it to work. Am I (are we) mistaken in that?
Kevin Beckman - December 14, 2005 03:53 PM (GMT)
The pill keeps the fertilized egg from planting itself in the uterine wall I believe. I feel sorry for Catholic hospital though.
Deltasix - December 14, 2005 04:00 PM (GMT)
Why do you feel sorry for the hosiptal?
Kevin Beckman - December 14, 2005 04:51 PM (GMT)
They shouldn't be forced to provide a service they believe is morally wrong. There's a thin line here on what the government can and can't make a business do. Especially since it involves the church.
Deltasix - December 14, 2005 04:57 PM (GMT)
If they don't want to provide healthcare to those in need, then don't allow yourself to be a Hosptial that allows emergencys to be brought to them. Otherwise treat people who need to be treated.
Keys - December 23, 2005 10:50 AM (GMT)
Well if you read the company's paperwork on the product it carries this warning.
Plan B is not recommended for routine use as a contraceptive.
This is why it probably shouldn't be over-the-counter. Its an 89% effective emergency contraceptive.
It is a hormone. Hormones have strong side-effects and there's always the risk when tampering with them, that the body may not return to its normal state for prolonged periods of time even after 1 or 2 doses. On rare occaissions it doesn't return but that hasn't happened in their studies with this drug. The company also says that the product isn't as effective in the Chinese population & its not understood why. Be aware also that there haven't been any studies of the effects of food or nutritional supplements on the drug. In the pregnancies that do occur while taking Plan B, 10% are ectopic. Diabetic women should be monitored while taking Plan B it says. Anticonvulsants reduce its effectiveness as well as rifampin.
Most Common
Adverse Events
Plan B
Levonorgestrel
N = 977 (%)
Nausea 23.1
Abdominal pain 17.6
Fatigue 16.9
Headache 16.8
Heavier menstrual bleeding 13.8
Lighter menstrual bleeding 12.5
Dizziness 11.2
It is 2 pills. The first taken within 72 hours of unprotected sex and the other 12 hours after the first.
I don't think this should be available on the shelf & I don't think the women who want it want to discuss the drug at the pharmacy counter. Its best left as a prescription drug in my opinion. With a listed side effect of abdominal pain & a risk of ectopic pregnancy if uneffective, a woman may think the abdominal pain is a side effect when its an ectopic pregnancy. The result would be her utopian tube will burst and will have internal bleeding when the pain is relieved & will have no idea anything is wrong until the bleeding comes out.
Deltasix - December 23, 2005 03:18 PM (GMT)
I see what you are saying, but the big issue that I am looking at here is....the FDA approved it for over the counter use. They looked into what you are saying and stated that it was fine for over the counter. Heck, colleges hand these things out like candy.
However, it was struck down for no reason, thats a serious problem. You might disagree with it being over the counter, sure. I can respect that. However, if it is approved and then randomly struck down, I have a problem with that.
Keys - December 24, 2005 09:22 AM (GMT)
You don't think its okay for the retailers to refuse to sell it? Why would they sell a product that they don't think is safe in light of all the corporate corruption that goes on in the FDA? Granted they should more publically say they're retaining their right not to sell an unsafe product. But if a company can't get a store to sell its product then isn't up to the company to change the product or find another means.
From what's known about the drug from the company itself, I think its irresponsible of colleges to distribute it unless they are making all this information clearly understood. The drug company is only interested in getting a return on its investment. If colleges distribute it then public opinion may turn on the retailers. Its a manipulation of the masses. Why isn't the company making it clearer about the dangers, side effects, and implictions of the use of the drug? They want to retain the right to mislead the consumer.
Deltasix - December 24, 2005 01:14 PM (GMT)
| QUOTE |
| You don't think its okay for the retailers to refuse to sell it? Why would they sell a product that they don't think is safe in light of all the corporate corruption that goes on in the FDA? Granted they should more publically say they're retaining their right not to sell an unsafe product. But if a company can't get a store to sell its product then isn't up to the company to change the product or find another means. |
Oh, its alright for stores not to carry it. However, for a store to carry it and then to deny a person use of it for no reason, I am totally against that. Its basiclly like saying "We have it back here, but we won't give it to you," which seems rather cruel.
Hospitals are not stores though. They are emergency medical facilities, where these things should be put out. Despite your personal views on the FDA, they did approve it, and they have a pretty good track record when it comes to these things.
The only corruption I see here is against what the FDA wants and what the conservitives wish to have, this not on the shelf. But seriously, look at it! It was overwhelming approved to go on the shelf by a large group of doctors and people working for the FDA, and then was randomly struck down for no reason.
Keys - December 25, 2005 02:38 AM (GMT)
I agree with you there. Kinda pointless to stock it & not sell it. What a waste. Also if a hospital is government substidized(& they all are) then they don't have total say on what occurs in that business. The government has say too. Its like I told my kids, an adult is someone who supports themselves without assistance. If someone else is helping to pay the way, then they have say so in what goes on. If you don't want interference then stand on your own. A religion based hospital that's government substidized allows the government say so in the interest of the people it represents.
Most of the FDA corruption is tied more with the food industry collaberating with the chemical industry.
Boru - December 25, 2005 03:44 AM (GMT)
True,
but at the same time I would not go to a Catholic hospital and expect to be able to get birth control pills or contraceptives. It doesn't make sense given the catholic church's view on contraceptives.
Deltasix - December 25, 2005 04:02 AM (GMT)
Then don't make it an emergency medical faclity and don't give it any gov't funding or status as such.
Deltasix - August 4, 2006 04:21 PM (GMT)
| QUOTE |
Plan B decision made before data review: FDA staff
By Susan Heavey Fri Aug 4, 1:00 AM ET
WASHINGTON (Reuters) - The decision whether the U.S. Food and Drug Administration should approve wider access to a morning-after contraceptive drug was made well before agency scientists finished their final review, two FDA officials said in court documents released on Thursday.
ADVERTISEMENT
Supporters of over-the-counter sales for Barr Pharmaceuticals Inc.'s Plan B pills have accused top FDA officials of hindering the company's bid for nonprescription sales for years, to please conservative supporters of President George W. Bush's administration.
The documents come just days after the FDA said it would reopen discussions over the drug, which can prevent pregnancy if taken within 72 hours of sexual intercourse. The delay had stirred debate over politics and science and held up the confirmation of two agency chiefs.
In a sworn statement in June, Dr. John Jenkins, director of the FDA's Office of New Drugs, said he learned in early 2004 that then-FDA Commissioner Mark McClellan had decided against approval before the staff could complete their analysis.
Plan B was rejected in May 2004, shortly after McClellan left the agency.
"I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins said in a deposition for a suit by the Center for Reproductive Rights that seeks easier access to Plan B. Jenkins later said he did not know if anyone outside FDA influenced the decision.
Another FDA official, who evaluated Plan B, alluded to White House involvement in a deposition given last month.
Dr. Florence Houn said she was also told that in January by Deputy Commissioner Dr. Janet Woodcock that Plan B needed to be rejected "to appease the administration's constituents" but that it could be approved later.
McClellan, who led the FDA when Barr submitted its application in 2003, said he gave updates to the White House as a matter of course but denied they told him what to do.
"If I was being given any direction on how I should act on this application, I would have remembered that because that never happened," McClellan said in a June sworn statement.
The FDA said on Monday it was willing to reopen discussions over the drug. The agency proposed sales from behind the pharmacy counter for women 18 and older.
Opponents say easier access to Plan B will spur promiscuity. Some equate the drug with an abortion pill, although the FDA says it is a contraceptive.
Supporters, who argue wider sales could reduce abortions, say behind-the-counter sales raise privacy concerns and point out that a growing number of pharmacists refuse to dispense birth control.
Simon Heller, lead attorney for the Center for Reproductive Rights, said those concerns mean the suit will continue even if Plan B wins restricted approval.
Barr filed an amended application in 2004 to allow nonprescription sales to those 16 and older. Last year the FDA postponed making any decision on Plan B, which is sold without a prescription in nine U.S. states. Emergency contraception is also available over-the-counter in dozens of other countries.
Agency officials have said the initial rejection of Plan B was based on the lack of data over whether younger girls could use the product safely. Other FDA officials previously said that they were left out of the decision to postpone a ruling.
Heller said the group does not plan to call on Acting FDA Commissioner Andrew von Eschenbach for a sworn statement. A Senate committee hearing on von schenbach's nomination to lead the agency was held on Tuesday.
FDA spokeswoman Susan Bro declined to comment on the suit. "What matters is where we are today (on Plan B)." |
Sakrotac - January 16, 2007 10:08 PM (GMT)
I don't have too much time here to go into detail, and so I'm sorry if I repeat what has been said; I have not much time.
But I would say, the "morning-after pill" should be allowed in cases of rape or critical conditions, and if Catholic groups believe that abortion should not be allowed, then they should not be allowed to allocate public hospitals to their beliefs. I understand that they would have paid for funding, but public hospitals should not be subject to religious views.
If that makes sense...
I don't mean any offence by this by the way, but as I said I do not have much time to arrange the post well.
| QUOTE |
| If they don't want to provide healthcare to those in need, then don't allow yourself to be a Hosptial that allows emergencys to be brought to them. |
I think this is along the lines of what I agree with.
