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» Scarleteen Boards: 2000 - 2014 (Archive) » SCARLETEEN CENTRAL » Safer Sex & Birth Control » Seasonale approved - without long-term studies

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Author Topic: Seasonale approved - without long-term studies
logic_grrl
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The FDA has just approved a new birth control pill, Seasonale.

It contains the same quantities of hormones as other birth control pills, but on a different plan - with 84 active pills before the 7 days of placebo pills. That means that a woman who takes it will only get 4 periods per year.

It's being marketed on the basis of convenience, but many doctors are concerned that there haven't been any long-term studies of the safety of suppressing periods like this. There are worries about the extra quantities of hormones a woman on Seasonale will be taking each year, and about the effects of retaining the endometrium for a longer time.

But the FDA approved Seasonale on the basis of a study that only lasted a year, so there's no data on the long-term effects at all. And even that study showed that Seasonale users had about twice the risk of unexpected breakthrough bleeding as ordinary pill users.

According to ABC news:

quote:
"Until they can show me data that there is no additional harm to women, giving them nine additional weeks of hormones, until that data comes through long-term studies, I just can't recommend that women jump on this bandwagon," said gynecologist Dr. Hilda Hutcherson, assistant professor of obstetrics and gynecology at Columbia University.

{...} Hutcherson said she's concerned young women will get a negative message about menstruation. "That your period is dirty, it's messy and it's inconvenient and it's a hazard to your health. I think that is a bad message," she said.




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Milke
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quote:
Originally posted by logic_grrl:
[B]And even that study showed that Seasonale users had about twice the risk of unexpected breakthrough bleeding as ordinary pill users.

Well, isn't that sort of a given? Women who are only meant to menstruate four times a year have much, much more time to have breakthrough bleeding in. It's not harmful, and it's a reasonably common side effect of pills that aren't quite the right dosage, and Depo-Provera, which can sometimes stop periods altogether. I suspect it's some of the research on Depo that 'proved' the safety of taking birth control pills this way.

quote:

{...} Hutcherson said she's concerned young women will get a negative message about menstruation. "That your period is dirty, it's messy and it's inconvenient and it's a hazard to your health. I think that is a bad message," she said.

I don't see how that's really a new message, though. Pad and tampon companies have been sending out that message for years, and teachers and even some parents have been enforcing it. This certainly isn't the right method for a lot of women, but it's something that has been used to deal with difficult periods for some time now, and I don't see the harm in that if it makes someone's life a bit easier.

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Milke, with an L, Mrs BD to you, RATS, TMNTP, MF, CWCD, WAOTA

This is the time to unite over the Revolution of the Pants


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logic_grrl
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quote:
It's not harmful, and it's a reasonably common side effect of pills that aren't quite the right dosage,

Agreed. But it seems like it would tend to spoil the "convenience" aspect if you had a high chance of getting unexpected breakthrough bleeding.

[This message has been edited by logic_grrl (edited 09-14-2003).]


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anahati
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Well, screwing around with your period can really mess up your hormones later in life. Women are meant to have their period roughly once every lunar month. If you disrupt your natural cycle by taking oral contraceptives every day to have no period, or only having 4 periods a year, you can be in for some long-term hormonal issues. I don't have any proof off-hand, but if one is considering doing that, researching long-term efefcts would probably be beneficial.

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Kite
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quote:
Originally posted by anahati:
Well, screwing around with your period can really mess up your hormones later in life.

Yeah? Please cite the research to support that conclusion.

quote:
Women are meant to have their period roughly once every lunar month.

By whom?


quote:
If you disrupt your natural cycle by taking oral contraceptives every day to have no period, or only having 4 periods a year, you can be in for some long-term hormonal issues.

Yeah? What kind of hormonal issues? Please cite... oh wait:

quote:

I don't have any proof off-hand

Ah. Never mind.


Seriously, even though I would gladly do away with my periods, I'm going to skip on Seasonale, mainly because of the spotting.


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logic_grrl
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As I understand it, at the moment there's no research on the long-term safety of skipping periods either with Seasonale or standard birth control pills. So there's no solid evidence that it will cause problems, but no solid evidence that it won't either.

But a number of doctors and experts have expressed their concern that it might potentially cause problems, and therefore feel that research needs to be done on the long-term safety issues before this is released onto the market.


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Kite
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I know what your point is, logic_grrl. I think it's a good one. I too have my doubts about the long-term effects of Seasonale (or skipping the placebo pills in a normal birth control pill). There are no studies about its long-term effects, and both sides use doubtful (at best) arguments to rally supporters.

For example, my doctor mentioned that when birth control pills were invented, doctors said that women should have withdrawal bleeding only to appease the Catholic church who might otherwise not have approved. That was her only argument for why it's safe to skip periods. Yeah, well, a little too political for me. On the other hand, the other camp repeatedly says things like "women are meant to have x periods a year", and I have to ask, by whom, and how do you know?

I don't understand why this issue makes some otherwise rational people become rabid. I have friends who think it's some kind of feminist duty to skip my periods, since they annoy me. Whatever.

OK, done rambling now

[This message has been edited by Kite (edited 09-14-2003).]


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MarvellousPurple
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quote:
Originally posted by Kite:
For example, my doctor mentioned that when birth control pills were invented, doctors said that women should have withdrawal bleeding only to appease the Catholic church who might otherwise not have approved.

Doesn't the Catholic Church disapprove of any and all birth control in its official doctrine and rules anyway? I know that lots of Catholics have different interpretations or use it anyway and all that, but if they were doing it to appease the Church... I guess it doesn't make much sense.

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does summer come for everyone, can humans do what prophets say?


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Kite
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Yeah, I know, it doesn't. Perhaps the Catholic Church doesn't disapprove of the use of bcp for medical (non-contraceptive) reasons? But yeah, that factoid is fishy.
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MarvellousPurple
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Actually, I think you're right. I checked with my lovely ex-Catholic partner and he's pretty sure that hormonal birth control is OK if it's for health reasons, and in that case they consider the fact that it prevents pregnancy a side-effect.

Anyway, back to the main topic. Sorry about that.

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does summer come for everyone, can humans do what prophets say?


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Insane
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There are many women out there who never get a regular period. These women can go 6-8 weeks without one. I haven't heard of any study that says these women should go on BC to regulate their period to avoid complications down the road. A women's body is gonna do what a women's body is gonna do!

On the other hand, I have a firm belief in science. A lot of people have the attitude that BC messes up one's natural cycle, it isn't what was intended (by God, nature) so it must be bad. Well, cancer treatments, insulin, antibiotics, vaccines, tylenol, TSH pills (for thyroid problems) ect.. are all 'unnatural products' yet they are used without a second thought. My understanding with Depo provera and the nova something (not nuva ring, but the little insert that is put into your arm through a tiny whole and works for 5 years) you don't get your period. (correct me if I am wrong! ) Were there any studies on the long term effects of depo?

I must admit, as a liberated female, I find my period a really drag. I dred it (unless I think I might be pregnant, then I rejoice when it comes! ) The way I look at it, I won't have it for the rest of my life, it allows me to have kids (indirectly), and at least I don't have to deal with erections at inoppurtune times like guys do!

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son: mommy pee in potty?
me-run as fast as a can strip him down and put him on the toilet, 2 secondes later
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repeat 4 times an hour, haven't see pee yet!


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anahati
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Kite -
My mom had to have a hysterectomy and complete ovarian removal, and several doctors and gynecologists believe this is in part due to a complication from taking a hormonal contraceptive.
I have had two miscarriages while on the pill (and using other forms of birth control, correctly) and again, several doctors blame this partly on the pact i was on the pill at the age of eleven due to period complications.
Lastly, I suffer from severe ptsd, and depression which has been linked to hormonal contraceptives.
So what I am trying to say is that hormonal contraceptives are not for everyone and for some people can do more harm than good. For others they're great.

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i used to be a superhero / no one could touch me / no, not even myself. - ani D


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Milke
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Norplant, Insane? Thoguh I'm sure there are other names too.

It *was* normal for women to have only a few dozen periods due to menarche in their late teens, having multiple children, and breastfeeding. Menstruating every 28 days for almost forty years isn't necessarily the norm. I don't think it's really fair for anyone to dictate what women's bodies *should* be doing, but if we become aware of problems we should be trying to remedy them, whether that means avoiding artificail hormones or embracing them.

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Milke, with an L, Mrs BD to you, RATS, TMNTP, MF, CWCD, WAOTA

This is the time to unite over the Revolution of the Pants


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KittenGoddess
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quote:
Originally posted by Insane:
There are many women out there who never get a regular period. These women can go 6-8 weeks without one. I haven't heard of any study that says these women should go on BC to regulate their period to avoid complications down the road. A women's body is gonna do what a women's body is gonna do!

Insane, I would just point out that there is a difference between your body naturally having a long cycle and using hormonal intervention to have a longer cycle. Yes, there are women who just have naturally long cycles and are perfectly healthy. However, having a naturally long cycle CAN be an indication of something that will be problematic in the long run. Speaking from experience, endometreosis caused me to have 40-50 day cycles...and I only have a very "light" case (so to speak). I'm on the pill partially to help treat that condition. So while I agree with you that everyone's body is different, and it's perfectly ok to have long cycles...I think it's important to note that long cycles like that can be indicative of problems also.

Personally speaking, I haven't seen enough convincing data about skipping periods to convince me that it's all that safe. Don't get me wrong, I'm not saying it's bad...I just don't feel like there's enough evidence to convince me personally. I would be much more comfortable with it after seeing some long term studies done, I think. Especially since it's being marketed on the basis of convenience. That in and of itself does make me uncomfortable. This pill doesn't seem to offer any added benefit as a contraceptive (ie. ease of use or added protection), so if it is being marketed more as convienence and less as contraceptive, then that could potentially be problematic.

I haven't had much of a chance to read up on this new pill (nasty computer virus crash-type thing has made my PC very not happy). Does anybody know if it's monophasic or triphasic or what?

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Sarah Liz
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emsily0
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i read a really excellent article about this in the new yorker awhile ago.

basically, yeah, the monthly-withdrawal-bleed thing is there to make the pill seem more "natural," and this was done to make it acceptable to the catholic church. the catholic church allows BCP for "health reasons," as far as i know, but not as birth control. so there's sort of a dichotomy there.

"seasonale" can be viewed as a step to a new kind of birth control. there are forms of hormonal contraception in the works that use a different mechanism, but work on the 4-bleeds-per-year principle, which would in theory be safer.

the main concern with a monthly bleed/big monthly hormonal changes (this includes a period) is cancer, especially breast cancer, because as hormones change, cells change, and as cells replicate repeatedly they are more likely to have genetic mutations that will cause cancer.

as far as "women are meant to menstruate every month," that's sort of up for debate. there is anthropoligical evidence (based on studies of tribes in africa) that during much of the history of our species, most women spent so much time pregnant that they only menstruated a few times in their life.

emily

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Boys and girls in America have such a sad time together; sophistication demands that they submit to sex immediately without proper preliminary talk. Not courting talk - real straight talk about souls - for life is holy and every moment is precious. I heard the Denver and Rio Grande locamotive howling off in the mountains. I wanted to pursue my star further. -Kerouac


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Heather
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However, emsily, because of women being pregnant so often, their bodies had different needs and functioned differently. To boot, for most of history, our life cycles were substantially shorter than they are now.

The thing is, periods do serve several purposes, namely, they allow women to shed the endometirum which they need to do if they are not pregnant AND they flush "bad" bacteria from the vagina, in conjunction with daily mucus, and we need that to happen to stay healthy. because studies still haven't been done on women who use the standard pill to skip periods, this is but a theory, but I'd be willing to bet that in those who regularly do, if the research is ever done (questionable, since women's health issues often get the bottom of the barrel), they may find much higher incidence of bacterial infections in those women.

I have a good deal of faith in science too, but without the proper experimentation and testing, we aren't talking science, we're talking, often, the FDA and the feds rushing something out because they know it'll be a money-maker (and I do think there are other things at hand here which really are misogynist -- after all, women with less periods will likely have more workdays, no?). On a personal note, they did the same thing with Nutrasweet, and some of us, like myself, got to have unexplained seizures for years until well AFTER it had been released and real testing was done after the fact which showed that that could have that effect.


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