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Doc Lightning
Doc Lightning

HOP Mad Doctor
Location: San Francisco, CA, USA
Member Since: 28th May 2001
Total posts: 13920
Posted:This is SOOO stupid. I hate when religion mixes with politics. But it's even worse when it mixes with science and medicine.

This is NOT going to help our teenage pregnancy rate. angry

http://nytimes.com/2004/05/08/politics/08FDA.html


Quote:
Morning-After-Pill Ruling Defies Norm
By GARDINER HARRIS





top federal drug official said yesterday that he rejected not only the judgment of an advisory panel but also the recommendations of his own staff when he refused to allow a morning-after pill to be sold over the counter.


Dr. Steven Galson, acting director of the Food and Drug Administration's center for drug evaluation and research since October, acknowledged in an interview that his action was not the norm.


"I am not trying to convey this decision as being common or usual," Dr. Galson said.


The morning-after pill, called Plan B, is an emergency birth-control medicine that is currently sold only by prescription. Made of high-dose birth-control pills, it can interfere with ovulation and perhaps prevent a fertilized egg from being implanted if taken within 72 hours of unprotected sex.


The pill's maker, Barr Pharmaceuticals, hopes to sell it over the counter, a prospect that seemed likely in December when a federal advisory panel voted 23 to 4 to approve Barr's application. The agency normally follows the recommendations of its advisory panels, especially when their votes are overwhelming. Barr's hopes were raised even further when Dr. Galson's staff similarly recommended approval.


But on Thursday, the agency sent Barr a "nonapprovable" letter, saying it had rejected the company's application because it did not provide enough information about how young teenagers would be able to use the drug properly.


In interviews yesterday, several former F.D.A. officials said that they could not remember another instance in which Dr. Galson, a career officer in the public health service, or any of his predecessors had overruled both an advisory committee and staff recommendations.


"I can't ever remember the center director ever signing a nonapprovable letter," said Dr. Raymond Lipicky, who retired from a top agency position in 2002 after 18 years in the agency. "In my experience, that never happened." Such letters are invariably issued at a much lower level than the director.


Dr. Robert R. Fenichel, who left the agency in 2000 after 12 years, said, "This is simply unheard of."


Their comments came in the midst of a fierce debate about whether the agency's decision was based primarily in science or politics.


Dr. Galson said he knew of just a single instance in the past 10 years in which one of his predecessors had overruled the conclusions of those below him. "This isn't common, but it's not unheard of," he said.


Dr. Galson did not just disagree a little bit with his staff and the advisory board. If he had, he would have suggested that Barr receive an "approvable" letter for its application. Such a letter tells a company that it could receive approval if it provides certain additional information.


Despite its cheery name, such letters are not good news for companies, some of which have worked for years to develop and provide the information requested. Still, they are better than "nonapprovable" letters like the one Dr. Galson decided to send to Barr. Such letters suggest that approval is unlikely, companies say.


By sending a nonapprovable letter, Dr. Galson said in the interview, "We said that the shortcomings are so large that we are not able to go that intermediary step."


He said Barr had failed to prove that girls younger than 17 could use Plan B safely without the help of a physician, because the company's study included just 29 girls younger than 17 and none younger than 14. He said he worried that such girls might be more likely to have sex without condoms exposing themselves to an increased risk of disease if they had easier access to Plan B.


"The worse-case scenario is that you've got a young couple and they would normally use a condom when they were having intercourse, but since they know they can run to the CVS to get Plan B, are they going to worry about that?" he asked.


Conservative groups endorsed the action.


"This is a prudent decision to say that we must consider the consequences if teens use this drug as a means of birth control," said Tony Perkins, president of the Family Research Council, a conservative group.


But the agency's decision to take into account how some people might change their behavior because a drug is more available is also unprecedented, critics charge. Dr. Scott Spear of the Planned Parenthood Federation of America, noted that the agency was unlikely to ask the makers of anticholesterol pills if people would eat more cheeseburgers when their drugs became available over the counter.


"It's a bogus issue," Dr. Spear said. "They should be asking if the drug is safe and whether it's effective. That's it."


But Wendy Wright, senior policy director at Concerned Women for America, a conservative group, said the agency's questions were entirely appropriate. "One cheeseburger is not going to kill you, while risky sex can be life-threatening in one instance," she said.




-Mike )'(
Certified Mad Doctor and HoP High Priest of Nutella

"A buckuht 'n a hooze!" -Valura

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Spanner
Spanner

remembers when it was all fields round here
Location: in the works... somewhere...
Member Since: 27th Feb 2003
Total posts: 2790
Posted:Burzaruka, I believe the title of this thread is the morning after pill. While the report itself may not mention religion, Lightning said:

Quote:
I hate when religion mixes with politics.



So I posted an example it as I thought it would be of interest to him. And if abortion has nothing to do with the morning after pill, I don't know what does.


"I thought you are man, but
you are nice woman.

yay,

:R"

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Pele
Pele

the henna lady
Location: WNY, USA
Member Since: 15th Dec 2000
Total posts: 6193
Posted:Quote:
And if abortion has nothing to do with the morning after pill, I don't know what does.



Morning After Pill are not concidered abortion because it does not expell a fetus. It works by not allowing an egg to implant/attach itself to the uterine wall, thus making it impossible to develope. Its window of opportunity is the first 76 hours after *possible* impregnation. This pill is to avoid abortions, so, it definately has something to do with it, but in a round about way.

And just for common knowledge, all medical clinics in the US have to keep records for legal purposes as well as records and inventory. If you walk in and say your name is "Baby Jane" then that is what they write you up as. A woman can not walk into a Planned Parenthood and get a pregnancy test without some record being done. I have known too many people who have worked with the organization to think otherwise.
I agree with Andy, it is still relatively easy to get, and in a much safer manner.

The only thing I can think of why this is such a big deal is the same issue as with abortions in many places, Planned Parenthood's are scattered in some areas, making affordable and forthright care hard to come by.

However, I think people reacting as if he had banned the drug outright is overreacting completely, and if he had I would fall in the ranks but it is still available, especially to those women who really need it, rape victims.
It seems to be more about choosing your doctor wisely than anything.

BTW, and because I think it fits the conversation, I watched the Penn and Teller BullSh!t show on PETA the other day and they had an awesome statement about Pro-Choice vs. Pro-Life.

"We are all Pro-Choice and Pro-life, what we choose is whether we are Pro- or Anti- Abortion." I have always felt that, and really like that statement.

Kindest regards,
Pele


Pele
Higher, higher burning fire...making music like a choir
"Oooh look! A pub!" -exclaimed after recovering from a stupid fall
"And for the decadence of art, nothing beats a roaring fire." -TMK

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NYC
NYC

NYC
Location: NYC, NY, USA
Member Since: 26th Aug 2001
Total posts: 9232
Posted:You know I like Penn and Teller but I have to respectfully disagree with them on this. I honestly don't think all people are pro-choice. I think there is a sizable group of people who thinks they should control whether or not a woman has a baby or not.

When we're talking about expelling an egg BEFORE it has a chance to implant in the uterus of the mother, I simply can't see that as an abortion. Women expell unfertilized eggs that COULD be fertilized into children every month. Maybe we should ban tampons too. After all, there's an unfertilized egg in there somewhere.

I don't want to get into a heated debate about abortion... mostly because it's far too complicated and frustrating to debate in posts.

When we're talking about terminating things that COULD THEORETICALLY become embryos as abortions, I become very worried.

I think that every child should be a wanted child.


Well, shall we go?
Yes, let's go.
[They do not move.]

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Burzaruka
enthusiast

Member Since: 13th Apr 2004
Total posts: 233
Posted:Yes Stone and Robotface, I understand these things and that is why I said
"But in all reality life doesn't fall into just to catagories now does it? "

Codoms arnt the only form of safe sex either.


I have to agree with just about everything NYC and Pele said.

Spanner, I don't understand why Lightning said anything about religoin in the first place, thats why I was asking about it. smile


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Phellan
member
Location: Kamloops, BC
Member Since: 20th Oct 2003
Total posts: 74
Posted:The Morning-After Pill is an extremely high dose of the normal birth-control pill that simulates pregnacy. All it does is prevent implantation of the egg, just like a normal birth control pill would. It just has the added side effect of making the person extremely nautious and sick (think Morning Sickness) for a few days after.

It's an emergency contraceptive just in case something goes wrong, that could be anything from the girl forgetting to take her pill up to something like rape. The US decision was heavily influenced by the Bush Administration which has been very active in curtailing, limiting, or out right removing sexual education and the like from gov't web sites and school education. The Admin has been very active in promoting the "Abstinence" concept--much like I don't know, say the Catholic church, which is where the religion and politics come in. It's soley being done to appease the religious right who make up a strong backing of the Bush Admin.

In Canada I *think* Birth Control Pills are availible OTC but I'd have to check with my g/f or someone on that :P Not my forte. . .


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Pele
Pele

the henna lady
Location: WNY, USA
Member Since: 15th Dec 2000
Total posts: 6193
Posted:Quote:
You know I like Penn and Teller but I have to respectfully disagree with them on this. I honestly don't think all people are pro-choice. I think there is a sizable group of people who thinks they should control whether or not a woman has a baby or not.





They were saying everyone believes in the right to make choices about one thing or another, not that specifically. Same thing with how everyone believes that at least someone/thing has the right to live, even if they think someone else does not.

They were making comments that the terms are too generic to use to head up any form of movements.

And because this episode was about PETA, it was about their use of the term Pro-Life for animals while in many ways members have been actively violent against people.

I include this here because I have seen the terms mentioned in this thread.

Just wanted to clarify! wink
Pele


Pele
Higher, higher burning fire...making music like a choir
"Oooh look! A pub!" -exclaimed after recovering from a stupid fall
"And for the decadence of art, nothing beats a roaring fire." -TMK

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Spanner
Spanner

remembers when it was all fields round here
Location: in the works... somewhere...
Member Since: 27th Feb 2003
Total posts: 2790
Posted:Quote:
Morning After Pill are not concidered abortion because it does not expell a fetus.



Pele, I didn't even say that the morning after pill is considered abortion. If you read back through the thread, I said:

Quote:
Her boyfriend at the time also didn't want to know, and she would have had an abortion because she knew, however much she would have loved the baby, she wasn't in a position to give the child the life it deserved.



What I meant when I said:

Quote:
And if abortion has nothing to do with the morning after pill, I don't know what does.



...was that the morning after pill, in many cases, prevents women from becoming pregnant and having to consider an abortion. Is this now clear?


"I thought you are man, but
you are nice woman.

yay,

:R"

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:Id say the "is it abortion or not issue" is kind of splitting hairs.



Use a pro-lifer who thinks the moment a sperm hits an egg it's a baby's definition of abortion, which is equal to murder. And this pill is abortion, and it's murder.



Use a medical definition, or one that I might use or you might use, and it's not abortion.



Yes I understood what spanner said, and I also read her reply further clarifying it. But Im more responding to pele claiming it's not abortion. To the people who oppose it it sure as hell is abortion.



Edit:just to clarify my intention is to distinguish between pro lifers who believe abortion is the moment a sperm enters an egg and those who use another definition, not generalize.



Another interesting thing I just remembered, I was actually an aborted fetus. I had come separated from the uterus lineing, and the doctors told my mother I would be still borne and wanted her to have them remove the fetus, she didn't and im still alive. And generally im not to retarded or malformed.


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Pele
Pele

the henna lady
Location: WNY, USA
Member Since: 15th Dec 2000
Total posts: 6193
Posted:Quote:
...was that the morning after pill, in many cases, prevents women from becoming pregnant and having to consider an abortion. Is this now clear?



And if you read what I wrote, that was how I closed my statement, and I did not address you directly as abortion was brought up more than once.


Pele
Higher, higher burning fire...making music like a choir
"Oooh look! A pub!" -exclaimed after recovering from a stupid fall
"And for the decadence of art, nothing beats a roaring fire." -TMK

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Spanner
Spanner

remembers when it was all fields round here
Location: in the works... somewhere...
Member Since: 27th Feb 2003
Total posts: 2790
Posted:Yes, I did read what you'd written. You didn't address me directly, however you did quote me directly, therefore I subsequently explained my opinion and asked whether it was clear enough for you. That is all.

It seems, whether in a round about way or not, we agree, so, in order to keep this thread relevant, if you'd like to discuss this misunderstanding further, feel free to PM me. smile


"I thought you are man, but
you are nice woman.

yay,

:R"

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MiG
MiG

Self-Flagellation Expert
Location: Bogged at CG
Member Since: 16th Apr 2004
Total posts: 3415
Posted:I'd say that im pro choice. But, as has been said before, i dont really care one way or the other.

That said, i reckon it should be over the counter, but the person buying should have to attend a counselling session regarding it. whether that makes it otc still i dont know.


"beg beg grovel beg grovel"
"master"
--FSA

"There was an arse there, i couldn't help myself"
--Rougie

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