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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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squarefish
(...trusty steed of the rodeo midget...)
Location: the state of flux
Member Since: 23rd Sep 2002
Total posts: 403
Posted:Lightniing,
sounds like the good Dr. Galson not only expects Bush to get a second term in office but also wants the "acting" part of his job description changed to permenant if the current administration gets a second term.

It's not very often that you see such a blatant example of an administrator using his powers to feather his own nest.

By issuing this "nonapprovable letter" over the advice of an advisory panel but also the recommendations of his own staff, he has basically spat in their faces and said that they don't know how to do their jobsmad2.

Perversity and arrogance reign supreme. frown


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Pink...?
Pink...?

Mistress of Pink...Multicoloured
Location: Over There
Member Since: 6th Apr 2002
Total posts: 6140
Posted:I know in England you can get the morning after pill free from NHS walk-in's and Dr Surgerys if you are under 21 (i think?)
Or you can get it over the counter at Chemists.

If you do buy it over the counter i'm sure that pharmasists would tell you how to use it safely and give advice to you if you were under 18!



Never pick up a duck in a dungeon...

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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:Quote:
Lightniing,
sounds like the good Dr. Galson not only expects Bush to get a second term in office but also wants the "acting" part of his job description changed to permenant if the current administration gets a second term.

Perversity and arrogance reign supreme. frown



Oh, I agree.

Amazing, isn't it? The entire administration acts this way.


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

"A buckuht 'n a hooze!" -Valura

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NYC
NYC

NYC
Location: NYC, NY, USA
Member Since: 26th Aug 2001
Total posts: 9232
Posted:It's my understanding that this is the only time that the FDA has approved a medication that the government has overruled.

It's especially disturbing since (from my understanding) there's a good chance that the sperm hasn't even reached the egg when the pill can still be effective. Are we now assuiming that birth control is an abortion? Are we going to start banning condoms because they're 'killing a life'?

The next level of loss of reproductive rights in women would have to be just legalizing rape. "I'm sorry ma'am, that man at the end of the bar would like to have sex with you and by refusing you are essentially killing the unborn child of your hypothetical intercourse."

But don't worry, women don't vote either. angry


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

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squarefish
(...trusty steed of the rodeo midget...)
Location: the state of flux
Member Since: 23rd Sep 2002
Total posts: 403
Posted:Aye,
it's a slippery slope.
And the current administration's just picking up speed frown


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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:"Every sperm is sacred!
"Every sperm is great!
"When you go and waste them
"God gets quite irate..."


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

"A buckuht 'n a hooze!" -Valura

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SpitFire
Mand's Girl....and The Not So Shy One
Location: Calgary, Alberta Canada
Member Since: 2nd Dec 2002
Total posts: 2723
Posted:*sigh* Like we should be surprised given the current administration?

The mentality? "Women aren't stable enough to make reasonable decisions about their bodies. We need to make it for them, and God's given us the guidelines."

mad2 censored censored mad2

I realllllly hope Bush gets fired by the American people. I don't have enough faith in the greater population, though, to actually think for themselves and see how much harm's been done by the current administration, and how many civil rights they've given up.

meditate

OK...I'm all better now...well, not really, but... wink


Solitude sometimes speaks to you, and you should listen.

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:My only issue with the morning after pill is it's to powerful of a drug to be put over the counter like a lot of pro-choicers are argueing, but I have no issue with it being offered at walk in clinics and whatnot. Another thing ive thought of is offering courses to pharmacists to give them basic couseling training so they could hand it to people who come into the pharmacy (ps chemists for you brits) (also at walk in clinics and when pharmacists hand it to you it could be free opposed to costing money)

Just from the perspective of someone who's been consumed with desire to self-harm and being around people who self harm, I think it's to much temptation to have such powerful drugs
lingering around on a shelf.


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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:It's really not that horrid of a drug. Simple counseling by a pharmacist should be sufficient. The panel and the drug manufacturer both took pains to ensure that the drug could be administered safely. Getting a drug approved for OTC administration is no small task and the fact that the panel overwhelmingly voted for approval means that they had this very nicely ironed out.

This is inappropriate, plain and simple.


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

"A buckuht 'n a hooze!" -Valura

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:I got the impression they were muscled into approving it by weighing benefits VS risks.

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telic
I don't want a title.

Member Since: 26th Jun 2003
Total posts: 940
Posted:It's pretty much the same as taking several normal birth-control pills, isn't it?

E pluribus unum, baby.

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:which aren't avaible over the counter.

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Pele
Pele

the henna lady
Location: WNY, USA
Member Since: 15th Dec 2000
Total posts: 6193
Posted:Quote:
Simple counseling by a pharmacist should be sufficient.



It should be, but often it isn't. At the same pharmacist, from two different techs, my mother was given contradictory advise on her medications, was given an inaccurate report of drug interactions at another pharmacist and my grandmother had the same.

You are expecting these people to not only hand out honest advice but a 14 year old, who is sexually active, to be responsible enough to follow that advice?

I agree with the ruling as long as the statistics of the tests are true (that there was no one under 14 and only a small percentage under 18, who, let's face it, would be the major purchasers).

I also agree that I think this would not help to disway some of the very young from having unprotected sex. It is too convenient. I think that it should be more like cigarettes or alcohol where you have to buy it with an id and a certain age. Under that age I feel *it should* be available to youths, but more as was described in other countries, free and from a clinic, because then perhaps the gravity of what they are doing may be felt more.

And I have been in the situation where I wish the Morning After Pill were available readily, so I am not against it at all. But I also don't think it should be between the aspirin and Pepto either.
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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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:
I know in England you can get the morning after pill free from NHS walk-in's and Dr Surgerys if you are under 21 (i think?)



Ah yes... religion mixing with not only politics, but medicine, is something I know a little about.

One of my friends made an appointment with a surgery which offers the morning-after pill.

At her appointment, only then did she learn that the particular doctor she visited was Catholic and would not prescribe it as it was against their beliefs. There were no more appointments available with alternative doctors before the 72 hour time scale ended.

In this case, she didn't become pregnant. I know the adage about not risking it in the first place, and I have nothing against the Catholic beliefs, but if that's how some doctors wish to practice, the surgeries should specify which doctors prescribe it and which doctors don't.


"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:pele the opposite happened to my family. My sister was actually prescribed birth control medicine by a doctor who made a mistake and the pharmacy picked up the mistake and called it in (she was supposed to get anti-biotics) and again my sister was prescribed muscle relaxants instead of anti-biotics by a doctor in outpatients and the pharmacist picked it up.

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Durbs
Durbs

Classically British
Location: Epsom, Surrey, England
Member Since: 23rd Sep 2001
Total posts: 5688
Posted:OMG - That's shocking!

Surely your friend could've / should've reported them to some governing body - No way can a doctor (legally) enforce their beliefs on their patience


Burner of Toast
Spinner of poi
Slacker of enormous magnitude

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NYC
NYC

NYC
Location: NYC, NY, USA
Member Since: 26th Aug 2001
Total posts: 9232
Posted:Quote:
My only issue with the morning after pill is it's to powerful of a drug to be put over the counter like a lot of pro-choicers are argueing, but I have no issue with it being offered at walk in clinics and whatnot.

Just from the perspective of someone who's been consumed with desire to self-harm and being around people who self harm, I think it's to much temptation to have such powerful drugs
lingering around on a shelf.



I've never heard anyone seriously arguing for over-the-counter status.

Also, as long as we're selling things like bleach and rat poison over the counter, I don't think "keeping dangerous things away from those that wish to hurt themselves" is a valid arguement. Hell, we sell guns without a prescription don't we? wink


Well, shall we go?
Yes, let's go.
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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:nyc people gravitate towards pills because they probably wont kill them. Usually only suicidal people will gulp down various poisons.

Also in canada getting a gun is quite an ordeal (the over the counter status arguement ive also heard in canada, what I pick up from american sources seems to be argueing over religion or pro choice vs pro life.)


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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:I think she's looking into it, Durbs smile

It's one hell of a loophole - if I remember correctly, she also got a hefty lecture about it from the doctor she saw at this surgery, listed in the Yellow Pages as offering the morning after pill, but without mention of that restriction angry


"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:Spanner did she end up pregnant?

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Parafinfairy
Parafinfairy

old hand
Location: Adelaide
Member Since: 5th Sep 2003
Total posts: 845
Posted:Actually its the same in my surgery. My doctor is Catholic and won't perscribe me the pill. Luckily I've not been in your friends situation with that doctor but I would imagine that if it was an emergency like that they would find someone else. I would hope so anyway. confused

Slicing the Loaf as we speak.

I need it..... Trust me!

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:Um what is a surgery anyways? Is it like when you walk into outpatients/emergency&ambulatory here where you just see whatever doctor is on call?

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Parafinfairy
Parafinfairy

old hand
Location: Adelaide
Member Since: 5th Sep 2003
Total posts: 845
Posted:Just the local doctor. You call them up and make an appointment. Either an emergency one or one in a day or so. You get signed to a particular doctor and then get seen by the same one everytime you make an appointment. Though in reality this doesnt actually happen as 'your' doctor is usually on holiday or too busy with other appointments etc! Besides after I got refused that last time by him I decided not to see him anymore!

Slicing the Loaf as we speak.

I need it..... Trust me!

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Big Andy
member
Location: Dallas, Tx
Member Since: 1st Apr 2003
Total posts: 186
Posted:I don't know how it is in other parts of the United States, but here in Dallas, you can pop on down to Planned Parenthood, see the doctor for just a sec, and for just a tad over what the pill would cost anyways, you get the pill with no need for parental intervention or to be responsible about it. They don't keep records, as they have strict policies about confidentiality and whatnot.

It's only slightly more difficult than buying an OTC drug! Why do we need to make it completely over the counter?! If they can get a ride to Walgreen's to get some pharmacists advice on it, or go to Planned Parenthood and get an actual MD's advice on it just as easily, I'm more comfortable with 14 year old girls going to Planned Parenthood.

If the girl would have to talk to her parents and get her HMO info and permission to go to the family doctor and blah blah blah... then I mihgt be in favor of making it slightly more available somehow. However with as easy as it is to get here in Dallas, I don't think it should be any different. Granted, It may be much harder to get ahold of in other states/cities in the country, I simply don't know. But here in Dallas, I think the Planned Parenthood option makes everything as easily available as it should be. My girlfriend and myself have benefitted from Planned Parenthood. It works fine.


I do agree that the ruling is probably most likely just a political stunt to give himself more job security. I do kinda support the decision though. I feel that if every city has clinics like Planned Parenthood with real MD's working them, then that should be sufficient. Young girls need to know how to take care of themselves, and going to a clinic to see a doctor briefly is probably better than seeing some pharmicist. Let's not forget about the Eckerd's Pharmacist in Denton Texas who refused to give the morning after pill to a rape victim. Perhaps Pharmacists' advice isn't good enough all the time.

Just my opinion, but I really don't think this worth the stink that the pro-choicers are making it out to be (I'm pro-choice BTW)


"We can't stop here! This is bat country!"

"Welcome to the U-S-A,
We'll treat you right, unless you're black or gay, or Cherokeeeeee!!"

-Brian Griffin from "Family Guy" (the dog)

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Dunc
Dunc

playing the days away
Location: The Middle lands
Member Since: 19th Aug 2003
Total posts: 7263
Posted:Quote:
...its the same in my surgery. My doctor is Catholic and won't perscribe me the pill...



confused angry censored

Now I'm not as knowledgable as I'd like to be but is that legal?? Can an NHS doctor actually refuse pescriptions in this country based on their own religous beliefs?


Let's relight this forum ubblove

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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:
Spanner did she end up pregnant?



No. But all she could do was wait and see.

If she had become pregnant, she wouldn't have had maternity pay, because she works on a freelance basis. 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.

The mind boggles as to how many abortions, adoptions and unhappy childhoods have arisen from women not being able to find a prescription in time for that reason frown

As far as I know, Custom Bug, it's legal.


"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:It might be legal, but I bet she could have a chance at dinging him in civil court, atleast if it was america or canada she could, I don't know how your civil court works over there.

But that would mean lawyers+hassle etc etc.. and if she lost she would be oweing money.


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Burzaruka
enthusiast

Member Since: 13th Apr 2004
Total posts: 233
Posted:I didn't read anything in that report that had anything to do with religion or abortion. Did I miss something?



Edit



If you are worried about getting pregnant either A don't have sex, B don't have unprotected sex. If you did either of those the topic of a morning after pill would be quite pointless. But in all reality life doesn't fall into just to catagories now does it?

confused Kind of sucks how life changes the rules without propper notice.

EDITED_BY: Burzaruka (1084229703)


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Stone
Stream Entrant
Location: Melbourne
Member Since: 13th Jun 2001
Total posts: 2830
Posted:Ummmmmmm, Burzaruka in the real world condoms have been known to break u know.

If we as members of the human race practice meditation, we can transcend our fear, despair, and forgetfulness. Meditation is not an escape. It is the courage to look at reality with mindfulness and concentration. Thich Nhat Hanh

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robotface
member

Member Since: 2nd Apr 2004
Total posts: 190
Posted:Primary purpose of the morning after pill is incase of rape.

Also people make mistakes, especially when under the influence.


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Page: 12

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