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August 9, 2005

Over-the-counter access for EC on the way?

From the Associated Press:

By month's end, federal health officials will decide whether to let women buy emergency contraception without a prescription _ and if so, if the morning-after pill will be treated more like aspirin off the shelf or like cigarettes.

Regardless of how the Food and Drug Administration ends the two-year saga, it isn't likely to settle the issue. States already are moving to expand access to Plan B, the pill that can prevent pregnancy if taken soon after unprotected sex, amid some competing efforts to restrict it.

And if the FDA does allow easier access, the pills probably would come with an age limit--anyone younger than 16 would still need a prescription. So drugstores would have to "card" young customers seeking to prevent pregnancy much as they now check cigarette buyers' ages.

How is unclear. Would morning-after pills sit next to other over-the-counter drugs or condoms?

Check out the whole article for what could happen if the FDA does approve Plan B for over-the-counter. (Keeping my fingers crossed...)


Posted by Jessica at August 9, 2005 9:34 AM

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Comments

I sure hope they don't approve it, especially in light of the WHO classifying combined estrogen and progestongen contraceptives as carcinogenic last week.


International Agency for Research on Cancer

PRESS RELEASE
N° 167


WHO 29 July 2005

IARC MONOGRAPHS PROGRAMME FINDS
COMBINED ESTROGEN-PROGESTOGEN CONTRACEPTIVES AND
MENOPAUSAL THERAPY ARE CARCINOGENIC TO HUMANS

An IARC Monographs Working Group has concluded that combined estrogen-progestogen oral contraceptives and combined estrogen-progestogen menopausal therapy are carcinogenic to humans (Group 1), after a thorough review of the published scientific evidence.

Group 1: The agent (mixture) is carcinogenic to humans.
The exposure circumstance entails exposures that are carcinogenic to humans.

Pretty scary, isn't it?


Posted by: exdem at August 9, 2005 1:32 PM

Go back and read the entire article, please.

"IARC MONOGRAPHS PROGRAMME FINDS
COMBINED ESTROGEN-PROGESTOGEN CONTRACEPTIVES AND
MENOPAUSAL THERAPY ARE CARCINOGENIC TO HUMANS"
...
"Notes:
Ralph Faggotter's Comments : Using the oral contraceptive pill can increase a woman's risk of breast,cervical and liver cancer but reduce her risk of ovarian and endometrial cancer. This WHO monograph will not answer the question "Is it safe for me to take the pill?" but does suggest that a woman's decision to take the OCP should not be taken without weighing the benefits against a measured consideration of her personal risk factors."
...

"An IARC Monographs Working Group has concluded that combined estrogen-progestogen oral contraceptives and combined estrogen-progestogen menopausal therapy are carcinogenic to humans (Group 1), after a thorough review of the published scientific evidence.

"At the same time, the Working Group stressed that there is also convincing evidence that oral contraceptives have a protective effect against some types of cancer.

"There are both beneficial and adverse effects for oral contraceptives and menopausal therapy. Each woman who uses these products should discuss the overall risks and benefits with her doctor."

You can find reports like this on lots of common drugs. It all depends on your family history.

That's is definitely good news about the over-the-counter EC, though.


Posted by: zap at August 9, 2005 2:05 PM

exdem;

The alternative (unplanned/unwanted pregnancies) are pretty scary too, and come with a whole set of risks of their own.

How 'bout if we just let folks assess their own risks (within reasonable limits, of course; we're talking about a widely tested drug here, not, say, arsenic) and decide which they, as individuals, are willing to take? That's what this is all about.


Posted by: katthemad at August 9, 2005 6:06 PM

Zap,
You are right...I should have read the notes. But, you are wrong to say that lots of common drugs have been been labeled
Group 1 Carcinogenics. I think it is especially scary that women take the pill every day.

Katthemad,
I think that women should assess their own risks in the manner that WHO recommends and Zap quoted for us: "Each woman who uses these products should discuss the overall risks and benefits with her doctor." I guess that means "prescription required".


Posted by: exdem at August 9, 2005 11:32 PM

Where did i say lots of common drugs have been labeled Group 1 carcinogenics? I meant there are lots of reports on the dangers of common drugs. If they are too dangerous to too many people, they get taken off the market. Also, this article is about emergency contraception, which you take for one day. The article you quoted is about the daily birth control pill, which you could take for years.


Posted by: zap at August 10, 2005 8:49 AM

Why would that mean prescription required? I am able to discuss my medical concerns with my doctor and I can certainly ask their opinion on a drug without them prescribing it.

I think I'll be assessing my own risks in the end regardless of recommendations.


Posted by: Anna at August 10, 2005 10:40 AM

Zap,
I have argued with the pro-BC people that emergency contraception is "nothing" more than a large dose of birth control pills. Well, if BC is now labeled a Group 1 Carcinogenic by the World Health Organization, shouldn't we who care about women start thinking about what this means to women's health? Look at the epidemic of breast cancer in this country? Is BC contributing to this? If it is, then YES, a women should need a prescription to take any form of BC, especially a large dose of it. At least that way, a doctor has some way to give advice as to whether or not this drug is a good idea for a particular women.

Now, to answer your question: "Where did i say lots of common drugs have been labeled Group 1 carcinogenics?"

In your first post you said: "You can find reports like this on lots of common drugs." This is a report that shows BC is a Group 1 Carcinogenic. Sorry if I somehow misunderstood you.

Anna,
"Why would that mean prescription required? I am able to discuss my medical concerns with my doctor and I can certainly ask their opinion on a drug without them prescribing it." Correct me if I am wrong, but I believe there are only two reasons why any drugs are "prescribed" and not not just sold over the counter. One of those reasons is to make sure that a doctor agrees that the drug is in a person's best interest after taking into account the person's health history, the drug's benefits versus the drug's risks. Perhpas you are one of the few that would ask your doctor his/her opinion about using over the counter drugs before you actually bought and used them. When a drug does not require a prescription, 99% of the people won't ask their doctor before they buy it. (The other reason prescriptions are sometimes required is to regulate controlled substances such as narcotics. This doesn't apply here.)


Posted by: exdem at August 10, 2005 1:34 PM

"When a drug does not require a prescription, 99% of the people won't ask their doctor before they buy it."

And...I still don't see your point, or the problem. So what? If it's determined to be safe to sell over the counter, then what is the issue? People take all sorts of drugs over the counter without asking their doctor - I'm not sure why this one is so different if it's allowed to be sold as such.


Posted by: Anna at August 10, 2005 3:28 PM

Anna,
I guess my question boils down to this: Is a Group 1 Carcinogenic safe to sell over the counter? I think not since each women's situation should be evaluated with knowledge. Perhaps a physician could decide for herself, but most of us do not have the education required to make an informed decision about a drug that can cause cancer, making it more dangerous for some women than for others.

Several years ago I read a pediatrician's article where he/she told other pediatricians that if they write a BC prescription for a girl who has never carried a pregnancy to term and whose mother has had breast cancer, then they were increasing that girl's chances of suffering from breast cancer astronomically, almost akin to guaranteeing that girl would be diagnosed with breast cancer at some point in her life. I had never heard of a BC/breast cancer link before, so I dismissed the claim. But I have never forgotten that article and now WHO claims that BC can cause breast cancer. How can EC possibly be safe for everyone, especially every young girl? I thought everyone who professes to be pro-choice cares about women's health.


Posted by: exdem at August 10, 2005 5:34 PM

Before a woman is prescribed the daily birth control pill, her doctor asks if her mother or aunts have ever had breast cancer. If not, the added risk of breast cancer is not enough to outweigh positive effects of the drug (including reduced risk of other cancers and no unplanned pregnancies). Because this pill is not safe for all patients, the prescriber takes into consideration family history, heart problems, and smoking before prescribing it. It's not offered over the counter for this reason. The article you quoted is about the daily birth control pill. EC, while it is a larger dose of hormones, is taken in just two doses. It's not going to give you breast cancer. Your comparison is completely wrong. It's like saying that since research has shown that consistent smoking can cause lung cancer, smoking for just one day will also cause an increase in lung cancer risk.


Posted by: zap at August 10, 2005 6:16 PM

Zap,
The problem is that if a drug is sold over the counter, no doctor gives advise to a women about how often it is safe to take the drug. I can think of several young women I know who would consider using EC as their only form of BC if they didn't need to go to a doctor to get it. This wouldn't be daily, but they might use it monthly or bi-monthly. Do we really know if this concentrated form of artificial hormones is safe when taken so regularly? Or will EC also be carcinogenic if taken every other month or so? We won't know the answer to this for years, so why not play it safe with women's health?


Posted by: exdem at August 11, 2005 1:40 AM

exdem,

Plan B doesn't have estrogen, only progestin.

I can think of several young women I know who would consider using EC as their only form of BC if they didn't need to go to a doctor to get it.

Studies didn't find any evidence of this.


Posted by: ema at August 13, 2005 8:52 PM

Ema,
Studies also have shown that there is no decrease in the rate of pregnancy when EC has been made very accessible.

Thanks for the info on Plan B having no estrogen. I didn't know that. Perhaps this drug will not be carcinogenic to the woman herself. I have read, however, a study linking prostrate cancer to men whose mother's took artificial progestin. Some researchers believe that traces of the hormone remain in the mother long after she last digests it. They believe that even trace amounts can cross the placenta in a pregnant women and into a developing male child. These studies are in no way conclusive yet, but the evidence is starting to mount.


Posted by: exdem at August 14, 2005 12:52 AM

The truth is that birth control and EC are *far* less dangerous than pregnancy (either terminated or carried to completion).

BC requires a prescription because you're on it for an extended period of time but the reality with EC is that by the time you get into see the doctor and get a prescription, it may be too late -- the sooner the better. I like the analogy to smoking.

Anti-choice propaganda teams try hard to blow things out of proportion -- portraying all abortions as late-term abortions, portraying the decision to have an abortion as something women do as lightly as getting their nails done and saying that teenage girls are just going to use EC instead of condoms and BC.

The real issue is reproductive rights.


Posted by: Tamara at August 23, 2005 4:51 AM