Saturday, July 31, 2004

Two For the Price of One

I'm quietly shaking my head in disbelief while reading a report that could've been aptly titled "The Not-So-Excellent Adventures of EC in Alabama".

Briefly, the Alabama health department tells all state clinics that they have to offer EC, or the state loses millions in federal funds. [In my opinion, a concern over federal funding is an inappropriate determinant of medical decisions. However, I'm not an expert on federal funding (read: I don't get how it works) so it's possible I'm missing the big picture.]

Because of personal objections to EC, 11 clinic nurses quit, and about 50 workers ask to be reassigned. [Let's get my bias out in the open, so we all know where we stand. When it comes to the MD/RN - patient relationship, the MD/RN's personal *whatevers* are irrelevant. You, the patient, are there to be treated and taken care of, not judged, converted, amused, convinced, befriended, or exposed to your health professional's Weltanschauung. A doctor or nurse recusing themselves from rendering care because of personal whatever--no problem. Personal whatever interfering in any way with the patient receiving appropriate care--big, huge problem.]

The Christian Coalition of Alabama(CCA) and Rep. Robert Aderholt (R-Ala.) say they've received calls from health department employees who had a moral objection to distributing EC. The CCA challenges the state's mandate and Rep. Aderholt contacts HHS Secretary Tommy Thompson.

In Secretary Thompson's reply letter: Thompson said in the letter -- which was made public on Wednesday -- that state clinics are expected to offer a "broad range" of contraceptive options but are not required to offer EC....[Translation: It doesn't matter what the medical standard of care is (offering EC to patients for whom this treatment is indicated). A government official has just 1) decided what your medical care should be, and 2) officially sanctioned malpractice (giving patients proper treatment isn't based on the eBay method; there's no offer/counter-offer).]

The CCA's stated goal: CCA President John Giles said that the group is trying to determine how it might help change the health department's policy on EC....

Rep. Aderholt's statement: Aderholt said he has "done all he can" to urge the health department to stop distributing EC, adding, "It's out of the federal purview,"....

[A religious group, a politician, and a government official confuse medicine and making medical decisions with a participatory democracy. Of course, since said medical decisions concern women's health, why not let everybody and anybody have a say in formulating the plan of treatment. After all, we can't possibly entrust women to make health decisions that would be in their best interest. You know, pretty little heads, vapors, and all that.]

The final word, from Dr. Thomas Miller, director of the Bureau of Family Health Services at the health department:

Although the state health department clinics are not required to distribute EC, Miller said that the agency would continue to distribute the pills, the Birmingham News reports. "It's excellent public health policy," Miller said, adding, "We have a rock-solid reason to do it. ... It's a good thing to do for the low-income women in this state. Other women already have access to it"

[Good for Dr. Miller. However, the rock-solid reason to do it is because it's the standard of care, not because it's a good thing to do for the low-income women. Medical problems affect both poor and rich women. Hence, all women should get the proper care, regardless of their income. In particular, low-income women should get proper care simply because they need it, not because we're good, or pious, or we're really, really nice and would like to help them out.]

But wait, there's more. Buried in this report from Kaisernetwork.org, I find this stunning editorial comment (emphasis added):

Although EC -- which can prevent pregnancy if taken within 72 hours after sexual intercourse -- works by preventing ovulation, preventing fertilization of an egg or inhibiting a fertilized egg from implanting in the uterus, medical and legal texts do not all agree on whether pregnancy begins at conception or when an embryo implants in the uterus (Kaiser Daily Reproductive Health Report, 7/2).

First, just because the words medical and legal are connected by an "and" in the original text, in real life legal texts (or, for that matter, TV Guides, religious texts, or engineering manuals) do not provide/establish medical information. Second, I know of no reference medical text that considers the start of the pregnancy an unresolved issue. Naturally, my curiosity was peaked. So, I followed the link given, thinking it would lead me to the reference. Here's the 7/2 Report, where we find the same statement, this time with a link to a 3/22 Report. This report sends us to another one, from 3/1...and on (2/19 Report)...and on (2/6 Report)...and on (1/12 Report). Unfortunately, the trail goes cold--in the 1/12 report there's no further link/reference for the initial statement.

However, fear not; I intend to remain on the case and call the Kaiser Family Foundation on Monday. I'm sure they'll be able to help and, once I track down this medical text, I'll report back.

Oh, That Naughty Speed of Light

For your amusement, via Pharyngula, some definitions from a Fashionable Dictionary (before you click, beware it's a tad irreverent):

Aristotle
A famous thief. Stole all his ideas from the library at Alexandria, built after his death, which just goes to show how sneaky he was.

Assumption
Something to be examined when it is our opponent's and taken for granted when it is our own.

Catastrophism
A theory describing what occurs when we're asked to explain our ideas clearly.

Defensive
Adjective for someone who insists on disagreeing with me, and goes on disagreeing even after I've said how right I am.

E=MC2
Probably a sexed equation, the product of a male obssession with speed. 'Is e=mc2 a sexed equation?...Perhaps it is. Let us make the hypothesis that it is insofar as it privileges the speed of light over other speeds that are vitally necessary to us. What seems to me to indicate the possible sexed nature of the equation is not directly its uses by nuclear weapons, rather it is having privileged what goes the fastest...' [Luce Irigaray, Le sujet de la science est-il sexue?]

Edge
A thing it is necessary to be on the cutting part of.

Elitist
Someone who knows more than I do.

Force
A thing you want with you.

Human nature
Fantasy. Fictitious entity, like Santa Claus or the tooth fairy or the free lunch. Humans have no nature, only culture; we can learn to fly, or live in the ocean, or echolocate, or pick things up with our trunks, if we will only concentrate.

Enough. Go read the original, while I learn how to echolocate.















Thursday, July 29, 2004

More Birth Control Methods

Never one to pass up a good discussion on birth control, let me see if I can add some information. Before we start, please keep in mind that this is going to be an extremely superficial review. (Just to give you an idea, the page count for my book is ~263 pages. All the methods mentioned in Vanessa's post are covered in detail, over more than 100 pages. So, again, what follows is very brief, and selective.)

First, read the article that inspired the initial post. Now, let's gently correct and add to it.

The U.S. Food and Drug Administration approved the first oral contraceptive pill in 1960...

Actually, the first birth control pill was approved in 1957. That is, it was approved for period control (to manage period-related problems). Only later, in 1960, was it also approved for birth control. (Just in case you were wondering how long this period control thing has been going on.)

"There have been no changes in the pill until the last few years," said Dr. Ted Peskin, professor of obstetrics and gynecology at the UMass Medical School in Worcester. "Just (recently) have all these adaptations to take birth control hormones (come out)."

Um, only if you've been living in the U.S. Most "adaptations" have been around in Europe for over a decade. As a rule, even if a birth control method is developed here and tested on American women, assume it will be available first in Europe, and about 5 to 10 years later here. (Can you tell I have a bit of a bee in my bonnet about this?)

Three-month pill -- This recently FDA-approved oral contraceptive directs women to take the pill daily for three months, rather than three weeks, allowing only four menstrual periods a year. Common brand name: Seasonale.



Vanessa wants to know if she should be excited or freaked out about Seasonale? Very good question, answered in detail in my book. However, since the release date is October (may I just say, "brilliant" marketing to schedule release around the time of a crucial Presidential election) we can't wait that long.

Briefly, when you use the Pill, on the regular birth control schedule (3 weeks on/1 week off), you no longer have a menstrual period. This is normal, and it's the way the Pill works. Again, if you use the Pill for, say, 5 years, you don't have a menstrual period for 5 years. So, when you use Seasonale, your menstrual periods are not affected at all, since you don't actually have any.

What you do have when you use the Pill, on the regular schedule, is a monthly withdrawal bleeding episode. (For clarity, I'll refer to withdrawal bleeding as the fake period.) Your menstrual period and your fake period have nothing to do with each other; they're not one and the same thing. The fake period is an artificial event, caused by manipulating the amount of hormones in the pill. The only reason you get a monthly fake period is because you take a specific dosage. Change the dosage and the monthly fake period is no more.

Moreover, there is no medical or biological reason to have a monthly fake period when you're on the Pill. The reasons the monthly fake period was built in the Pill are "designer" ones: Puritanical politicians, doctors who didn't wash their hands, Catholic Popes, and dead rabbits. (I'm not being flippant; these are actual, historical reasons.) So, when you take Seasonale all you're doing is changing the frequency of the fake period, from monthly to trimonthly. Of course, just knowing about the real and the fake period isn't enough to fully answer our initial question about Seasonale. There are other factors you need to consider before you can make an informed decision, but we have to move on.

Three-month shot -- A progesterone injection, administered by a doctor, that lasts for three months to prevent pregnancy. Common brand name: Depo Provera.

...

Peskin said side effects of the three-month shot could include a slight weight gain of 5 to 10 pounds and irregular bleeding for the first three to six months, followed by no periods after a year.



Only one randomized clinical trial has studied the effect of Depo-Provera on weight. It found no evidence that Depo-Provera increases appetite or weight. On the other hand, several observational studies that looked at this effect have reported conflicting results: some reported weight gain of up to 16.5 lbs after 6 years of use; others reported no weight change.

Regarding the irregular bleeding, about 35% of users experience irregular bleeding, and 27% experience prolonged bleeding during the first 3 to 6 months of use. After one year of use, about 50% of women become amenorrheic (stop bleeding altogether).

The Patch -- A weekly one-and-three-quarter-inch patch that releases hormones through the skin directly into the bloodstream to prevent pregnancy. Women put on a new patch once a week for three weeks, allowing for a menstrual period during the fourth week each month. Common brand name: Ortho Evra.



Ortho Evra is a good method to use if you don't want to remember to take a pill every day. And just because it's a patch, doesn't mean you have a real menstrual period. Just like with the Pill, you only have fake periods when you use the patch. (This is one of the newer methods; it's only been available for ~2 years).

The Ring -- A flexible two-inch diameter ring inserted into the vagina to release hormones for three weeks to prevent pregnancy, allowing for a menstrual period during the fourth week each month. Common brand name: Nuva Ring.

...

"The ring in my practice is very popular because I use it a lot," Power [a Leominster gynecologist] said. "Women can be squeamish at first, but often women who get it, like it."



Two possible reason to be squeamish about NuvaRing: once you insert it, you can still feel it; either you or your partner can feel it during sexual intercourse. For the first scenario, take it out and re-inserted right away. Remember, the ring is not a barrier method, so it doesn't need to fit over the cervix. Second scenario, take it out (and leave it out) while you're making love, and re-inserted once you're done. Very Important: don't leave it out for more than 3 hours! (This ring is also one of the newer methods; it's been available for ~2 years.)

Intrauterine Device -- A small device inserted by a doctor into the uterus to release hormones that prevent pregnancy, which can last five years or more. Common brand name: Mirena.

...

Peskin said an intrauterine device, called IUD, is also a safe, effective form of birth control.

"It got a bad (reputation) in the U.S. because of the previous infection rate, but that's based on old information," Peskin said.



Mirena


GyneFix

I could not concur more with Dr. Peskin: the IUD is one of the best methods of birth control. Despite the fact that sterilization ("having the tubes tied") is the most common method of birth control used by American women, the IUD offers you better pregnancy protection: 0.4 vs. 0.1 first year failure rate. And this only scratches the surface. For years, the Europeans have been using the "next generation" IUDs, GyneFix and GyneFix mini (both frameless IUDs). Bottom line: maybe the IUD is the best method for you, or maybe not. What is unquestionably best for you: to be aware of all the available birth control options, so that you, in consultation with your physician, can make not only an informed decisions, but one that best fits your unique needs.

Finally, one feministing commenter mentioned Pill/patch/ring use and side effects, in particular: diminished sex drive, mood swings, and increased growth of body hair (hirsutism).

Both natural (body-made) and synthetic (man-made) hormones can cause side effects. For example, too much natural estrogen increases your risk of uterine cancer; too much synthetic estrogen increases your risk of blood clot complications. As a rule, most of the side effects of hormonal birth control are "minor" (BTS, breast tenderness, etc.); the life-threatening ones are rare. (However, if you decide to use a hormonal method, you should be aware of all the risks--minor, as well as major ones.) I don't have time to go over all the risks now, but allow me to clarify something about the three aforementioned risks: diminished sex drive, mood swings, and hirsutism.

Female sex drive (libido) is a complex issue. In other words, in men, low testosterone levels = low sex drive. In women, just measuring the testosterone level is a problem. (Women have much lower levels vs. men, and most tests are not sensitive enough to accurately detect them.) Moreover, in women there's no such thing as a "set" relationship between the testosterone level and libido. That's because, in women, sex drive is determined by a number of factors--past sexual experiences, estrogen levels, etc. (In other words, even if you give a woman with low testosterone levels, and a low sex drive, supplemental testosterone, the physiological response can be present--more blood rushes to the vagina--but her sex drive isn't changed--she reports no improvement in sex drive.) But I digress; back to the Pill and its effect on sex drive. Some ongoing Pill users report an increase in sexual thoughts. Some women who discontinued Pill use report reduced sexual thoughts. The [limited] studies available suggest that Depo-Provera (and Lunelle, a combination shot not available in the U.S.) rarely cause loss of sex drive (or depression, for that matter). Bottom line: some women do perceive/experience changes in sex drive and mood when using hormonal birth control; however, a direct relationship between these changes and the hormonal birth control method is not always evident.

Hirsutism, or, in a woman, an increase hair growth in a male pattern, is caused by an excess of "male" sex hormones, like testosterone. (Mind you, both men and women produce testosterone; however, because men produce much higher amounts, testosterone is referred to as a "male" hormone.) So, in order to treat hirsutism you want to lower the testosterone level. Enter the Pill, one of the methods used to actually decrease hirsutism. Again, the Pill decreases hirsutism, it doesn't increase it. The way it does that: by reducing the amount of free testosterone (the free fraction is active; the bound one isn't). Incidentally, this is the same mechanism by which the Pill decreases and improves acne.

OK, enough for today. I'll try to post something about male birth control soon.

Update:
I just realized I left out one "designer" reason for creating a fake period, one that has to do with doctor's shortcomings. (A bit biased in favor of doctors, aren't we?--ed Yes, but only a bit.) I've amended the original text.

A commenter points out that Seasonale was only approved in 2003. Correct. However, Seasonale is not so much a "new" method, as it is a new brand name (over 10 other brands have the exact same formulation), and pack/label. In Europe, Pill packs already carry these labels; even in the U.S. this regimen has been used for decades. Granted, Seasonale's pack looks much nicer than pill strips with the placebo pills cut out, and held together with a rubber band; still it's more of a form novelty vs. a function one. (Contrast this to the patch. Until Ortho Evra came out there was no other brand/method that delivered birth control through the skin.) In any case, I must admit that when I wrote the post it hadn't even occurred to me that what I just mentioned here wasn't common knowledge. Perhaps we in the medical profession haven't done such a good job of educating women about this topic? (I'd rather like to believe I'm wrong about this.)

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Skipping Your Period With a Triphasic Pill, Part II

You can use a triphasic pill brand to skip a period. Before we review the regimens used to skip a period with a triphasic pill brand, let me clarify a few terms.

Triphasic, Skip a Period

Combination birth control pill - each active pill has a combination of estrogen (ethinyl estradiol) and progestin (synthetic progesterone). Each placebo ("sugar") pill is inactive; it does not have hormones.

Pill brands came in 21-, 28-, and 91-day packs. The 21-day pack has only active pills. The 28- and 91-day packs have an extra 7 inactive, or placebo pills.

The placebo pills are reminder pills. They're put in the pack to get you into the habit of taking a pill every day. They serve no other purpose.

Monophasic brand - all active pills have the same amount of estrogen and progestin. All active pills are the same color. In 28-day packs, the 7 placebo pills are a different color. That's two different colored groups of pills per 28-day pack.

Triphasic brand - the active pills have either the same, or two different amounts of estrogen, and two or three different progestin amounts. All active pills with the same amount of estrogen and progestin are the same color--usually three groups of colors per 28-day pack. The 7 placebo pills are a different color. That's four different colored groups of pills per 28-day pack.

For more on monophasic vs. triphasic, see Skipping Your Period With a Triphasic Pill, Part I.


Skipping a period - when you use a combination birth control pill--monophasic or triphasic--you don't have a menstrual period for the entire time you take the pill.

The monthly bleeding you experience while on the Pill is withdrawal bleeding, a chemically induced event. This artifice was introduced for political, religious, etc. reasons by the Pill inventors; it serves no known medical function.

The menstrual period and withdrawal bleeding are not one and the same thing.

Bottom line: When you use the Pill and you modify the regular 21/7 (21 days of active pills/7 days of placebo pills during which you experience withdrawal bleeding) to an extended regimen, like the 84/7 one, you are only changing the frequency of withdrawal bleeding; from monthly, to once every three months. The regimen change has no effect on your menstrual period since, while on the Pill, you don't have a menstrual period.

Triphasic, Extended Regimen

If you want to skip your period, using a monophasic Pill brand is best.

Why? Because all monophasic active pills have the same amount of hormones. This means steady hormone levels and less likelihood of nuisance side effects like breakthrough bleeding/spotting (BTB).

BTB is not dangerous to your health (for most women) but it's a significant inconvenience (not to mention a major reason women discontinue Pill use).

Because triphasic pill brands have varying hormone levels which fluctuate--usually, from week to week--you're more likely to experience BTB if you use a triphasic brand to skip your period.

So, what are you to do?

If you're not already on the Pill, start using a monophasic brand to skip your period.

If you're already using a triphasic brand and it suits you, no need to switch to a monophasic. Go ahead and use your existing triphasic brand. If it works, great! If not, you can always change to a monophasic brand later.

Now, if you're already on the Pill, a triphasic one, you're most likely on the regular regimen: 21 days of active pills, followed by 7 days of placebo pills during which time you experience an episode of bleeding.

In order to eliminate that monthly bleeding episode, or shift its frequency (to, say, once every three months) you have to modify the regular 21/7 regimen you've been using. You need to use an extended regimen, and you have several options to chose from.

Before we go on to the actual regimens, note the following:

- no matter which regimen you chose, you're still protected against pregnancy (provided you don't miss any pills, of course)

- the regimen recommendations to follow are based on clinical experience (there are no formal studies on triphasic extended regimens)

- since Ortho Tri-Cyclen* is a commonly used triphasic brand, I'll use it to illustrate the various extended regimens

*There are 28 pills in the pack. Four groups of 7 pills, each group a different color:


White pills (seven)- each pill has 0.035 mg estrogen (ethinyl estradiol) and 0.180 mg progestin (norgestimate)

Light blue pills (seven)- each pill has 0.035 mg estrogen and 0.215 mg progestin

Blue pills (seven)- each pill has 0.035 mg estrogen and 0.250 mg progestin

Green pills (seven)- each pill is a placebo pill (no hormones)

Notice how the amount of estrogen is the same throughout the month, while the progestin amount keeps increasing.

And now, without further ado, the triphasic regimens.

Triphasic Regimens

To skip one period or delay it by one week:

A) Take the 21 active pills (first three weeks of pills). When you get to the 7 placebo pills (last week of pills) throw them out and instead take the third week of active pills from a new pack.

(Ortho Tri-Cyclen) Take 7 white pills + 7 light blue pills + 7 blue pills. That's 3 weeks and 21 pills. When you get to the 7 green pills, discard them, and take 7 blue pills from a new pack instead. Once you're done, either wait one week and then start a new pack (delays bleeding by one week), or start a new pack right away (skip bleeding).

7 white pills + 7 light blue pills + 7 blue pills + 7 blue pills (from a new pack)
Wait one week, then start a new pack/Start a new pack right away.

B) Take the 21 active pills and the 7 placebo pills (four weeks). Wait for one week**. Start a new pack and take the 21 active pills, followed by the 7 placebo pills. [This regimen shifts the bleeding episode by one week during the second month.]

**VERY IMPORTANT: You are not protected against pregnancy during the week you delay taking the next pack. You must use an alternate birth control method (condom, diaphragm, sponge, etc.).

7 white pills + 7 light blue pills + 7 blue pills + 7 green pills
Wait one week (no pills). [No Pregnancy Protection!]
Start a new pack.

To delay bleeding for months:

1. Take the 21 active pills (first three weeks of pills). When you get to the 7 placebo pills (last week of pills) throw them out and instead start a new pack.***

7 white pills + 7 light blue pills + 7 blue pills
Start a new pack (take active pills only).

***This is the regimen most likely to trigger BTB.

2. Take the 21 active pills (first three weeks of pills). When you get to the 7 placebo pills (last week of pills) throw them out. Start a new pack backwards, after first discarding the 7 placebo pills from this new pack.

[Pack #1] 7 white pills + 7 light blue pills + 7 blue pills + [Pack #2] 7 blue pills + 7 light blue pills + 7 white pills {+ [Pack #3] 7 white pills + 7 light blue pills + 7 blue pills}

3. Start with three new packs (or two). Take the first 7 active pills from each of the three packs (three weeks total). Then take the next 7 active pills from each of the three packs (three weeks). Finally, take the last set of 7 active pills from the three packs (three weeks). Stop for one week, then restart.

[Pack #1] 7 white pills + [Pack #2] 7 white pills + [Pack #3] 7 white pills + [Pack #1] 7 light blue pills + [Pack #2] 7 light blue pills + [Pack #3] 7 light blue pills + [Pack #1] 7 blue pills + [Pack #2] 7 blue pills + [Pack #3] 7 blue pills
Stop for one week, then restart.

So, there you have it. These are some of the regimen options you have if you want to use a triphasic Pill brand to skip your period.

As you can see, using a triphasic for an extended regimen can be a bit confusing. Also, you're more likely to experience BTB. So, even if you're already using a triphasic on a regular 21/7 regimen, consulting with your physician about switching to an extended regimen is most helpful.

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Wednesday, July 28, 2004

Natural Family Planning, Part III

Picking up where we left off*, Fertility Awareness Methods (FAMs) work by preventing insemination (or fertilization). You identify the fertile period of the monthly cycle (with the aid of fertility indicators), and then you either abstain from sexual intercourse (periodic abstinence) or you use a back-up method during that time.

Fertility Indicators (FIs)

A quick word about fertility indicators (FIs): they are indirect or direct. Some examples of indirect FI are cervical mucus or position, basal body temperature, etc. Direct FIs are ultrasound visualization of ovulation, and blood or urine levels of sex hormones. Because direct fertility indicators are hard to incorporate into a birth control method (imagine lugging an U/S machine or a phlebotomist around all day long), most FAMs use indirect indicators. Only Persona uses direct ones (urine hormone levels).

Failure Rates

Overall, FAMs have a 1st year failure rate of 25% with typical use, and from 1% to 9% with prefect use. The efficacy of the methods in this group depends on two things:

1) Ability to accurately identify the fertile days of the menstrual cycle.

Direct fertility indicators identify the fertile days of the cycle more accurately than indirect ones. Most FAMs use indirect fertility indicators. For these, older methods identifying and tracking a combination of fertility indicators offers better pregnancy protection vs. relying on only one indicator.

2) Ability, or willingness, to either abstain from sexual intercourse (natural family planning) or to use a barrier method during the fertile period.

The best way to use a FAM is to not have sexual intercourse during the fertile period. (Actually, the safest way to use FAMs is to abstain from sexual intercourse from the start of the menstrual cycle, until the end of the fertile period. This is sometimes referred to as the Post-ovulation method, and it is the most effective method. The 1st year failure rate is 1%, with perfect use.)

FERTILITY AWARENESS METHODS (FAM)

a) Calendar Method

Rhythm (Ogino-Knaus)

Standard Days Method (SDM)

CycleBeadsCycleBeads


b) Basal Body Temperature (BBT) Method

(Bioself 110/Mini-Sofia, LadyComp/BabyComp, Cyclotest-2)


c) Ovulation Method

Billings Method (Cervical Mucus)

Creighton Model

TwoDay Method


d) Cervical Changes Method

e) Sympto-Thermal Method

f) Personal Hormone Monitoring Method

Persona


A brief review of the individual methods:

a) Calendar Method

Rhythm (Ogino-Knaus)

Standard Days Method (SDM)

CycleBeadsCycleBeads


With the Calendar method you attempt to calculate the start and the end of your fertile period, by tracking the length of your past menstrual cycles. The length of the past menstrual cycles is the indirect fertility indicator. This method is based on the 1930s theories of Drs. Ogino and Knaus and it is also referred to as the "Ogino-Knaus" or the "rhythm" method.

The Standard Days Method (SDM) is a new and simplified Calendar-based method. Instead of observing and tracking the length of your menstrual cycles, you assume that there's a fixed period of fertility ("standard rule") from Day 8 to Day 19 of your cycle (regardless of the length of your cycle). Thus, you abstain (or use a barrier method) during that interval.

CycleBeads is a string of color-coded beads that represent a woman's menstrual cycle. Each bead represents a day of the cycle and the color helps you determine if you're likely to be fertile that day. Think of CycleBeads as a "visual aid" for the SDM method. According to its developer, the 1st year failure rate is 5% with perfect use, and 12% with typical use.

b) Basal Body Temperature (BBT) Method

(Bioself 110/Mini-Sofia, LadyComp/BabyComp, Cyclotest-2)


With the Basal Body Temperature (BBT) method you attempt to predict the end of the fertile period by observing the changes in the BBT. (BBT refers to the resting core body temperature.) The probable 1st year failure rate is 20% with typical use, and 2% with perfect use.

A number of "computerized thermometers" have been developed to be used in conjunction with BBT. Briefly, this is how they work: you measure your BBT in the usual manner and then you enter those measurements, together with information about your cycle length, into the device (instead of charting it on the graph paper). The device then displays an indicator light for the fertile period of the cycle.

The efficacy information for these devices is scant. One study found a 9% failure rate for Bioself, but the women using it were already experienced in using FAMs. The only data on the failure rates of Ladycomp/Babycomp is based on an observational study (5.3% failure after 1st year, 6.8% after 2nd year, and 8.2% after 3rd year). (This type of study is not reliable enough and can not be compared with the more exact studies used for other bc methods.) Cyclotest-2 probably has an efficacy similar to Bioself, but more studies are needed to confirm all these rates.

c) Ovulation Method

Billings Method (Cervical Mucus)

Creighton Model

TwoDay Method


The Ovulation method attempts to identify the start of the fertile period, by observing and tracking the changes in the quality and quantity of the cervical secretions. It is also called the "Billings" method (after the physicians who first described it), or the "Cervical Mucus" method (cervical mucus is another name for cervical secretions). The 1st year failure rate is about 40% with typical use, and 3% with perfect use.

The Creighton Model method is a variation of the ovulation method. It is a standardized educational program in which you are taught when you are most likely to ovulate based on observations of cervical secretions (just like the ovulation method). In addition, you are taught to monitor if your reproductive system is functioning normally or abnormally, based on observations of several biomarkers (e.g., breast tenderness, abdominal discomfort, vaginal discharges, etc.). According to its proponents, the 1st year failure rate is about 17% with typical use, and 1% to 4% with perfect use.

The TwoDay method is a new and simplified ovulation method. Instead of sampling, observing, and tracking the changes in your cervical secretions, you only need to observe if secretions are present or absent. "Secretions" are defined as anything that you perceive coming from the vagina, except menstrual bleeding. The estimated 1st year failure rate is 3% with perfect use.

d) Cervical Changes Method

This method attempts to identify the fertile period by observing and tracking the changes in the consistency and position of the cervix. Rarely used alone, this method is usually used in combination with other indicators, like BBT and/or cervical secretions.

e) Sympto-Thermal Method

This method attempts to identify the start and the end of the fertile period by using several indirect fertility indicators (cervical secretions, cycle length, BBT) simultaneously. The 1st year failure rate is between 4.9% and 34.4%, with a mean of 16%, with typical use, and 2% with perfect use.

f) Personal Hormone Monitoring Method

Persona


Persona Monitor

This method identifies the fertile period by measuring urinary hormone levels. This is the only FAM which uses a direct indicator (urinary levels of estrogen and luteinizing hormone) to determine the fertile period. Persona, a personal hormone monitoring device, has a 1st year failure rate of 6.2% with perfect use (according to its manufacturer).

Note: ClearPlan and Persona are manufactured by the same company. However, ClearPlan is a Fertility Monitor, not a birth control method and should not be used as such.


* Natural Family Planning part I and II.

ETA: Despite my conviction that I know how to indent the text came out looking funny so I changed it back to normal.

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Monday, July 26, 2004

I'm Back

Just finished the corrections for the final draft. Able to exhale now. Unfortunately, I missed the discussion about Ms. Richards' and Ms.Ehrenreich's articles. I did, however, manage to read one excellent relevant post at Mouse Words (via ampersand). Actually, I managed to read a number of other interesting posts there, on the economics of beauty, and the maternal/fetal issues raised by the apparent murder of a pregnant woman.

I also found this scary article Feds Alarmed at Internet Rx Sales. I'll come back to this piece in a second, but first I wanted to mention a related snippet I saw last night on NBC (I think it was Dateline).

The intrepid reporter enters false health info (the height and weight of her dog--something like 4 feet and 20 lbs) while ordering rx meds (Prozac or Valium, didn't catch the exact order) from an on-line pharmacy. Then she tracks down the physician who approved the order, travels to Europe (? The Netherlands) to talk to him, and confronts him about her order. As so often happens in situations like these, the doctor was unbelievably inarticulate (granted, apologetic, but still). At no time does he ask the reporter why she supplied incorrect information, and then, having done that, why she expected to receive proper care? Or why should she not assume any responsibility for her action? Here we have a very important topic--lay people wanting, and being able, to self-medicate--that merits a lot of serious and nuanced discussion, and all we manage to learn from this interview is that the reporter is a good trickster. What a squandered opportunity!

However, fear not. If we (patients and health-care professionals alike) can't muster up enough brain power to conduct ourselves in a manner benefiting our best interests, our "beloved" leaders are ready (and eager) to step in. Which brings me back to the article I mentioned. Here are the first two paragraphs:

Americans are purchasing billions of dollars worth of prescription drugs over the Internet with no guarantee that they are safe, effective, or even real, federal investigators tell lawmakers.

Law enforcement officials also say they are now basically powerless to stop the flood of prescriptions -- many of them illegal -- arriving in the U.S. from foreign countries in millions of mail shipments.


And there you have it! This has nothing to do with your health, or concerns over your well-being. It's all about the government losing control over your thoughts and actions. Think I'm being a tad over-dramatic? Perhaps; however, when it comes to the doctor-patient relationship and the ability of individuals to act in their own best health interests, I am a purist. Read the justification for nanny-ism offered by a homeland security (really, homeland security for Prozac?) official, and tell me you don't feel insulted and infantilized:

"This is not just getting the same drug at a bargain price. There are risks," says Richard M. Stana, a homeland security and justice investigator with the General Accounting Office, the investigative arm of Congress.

(Emphasis added.) Um, yes, obviously there are risks involved in ordering (and taking) meds from an unknown source. There are also risks involved in crossing the street, becoming pregnant, driving a car, taking aspirin, and making love. The beauty (read responsibility and reward) of being a competent adult is that we are able to conduct a "risk/benefit" analysis and decide for ourselves what is in our best interest. Of course, we may (and we should, and often do) consult relevant professionals to help us with our decisions. But, at least when it comes to medical decisions, politicians, and government officials and administrators should not be the ones in a position to decide what's best for us.

Finally, look at the listed sources for this article:

SOURCES: Sen. Carl Levin (D-Mich.). Richard M. Stana, director, Homeland Security and Justice Team, General Accounting Office. William Hubbard, FDA associate commissioner for policy and planning. Karen P. Tandy, administrator, Drug Enforcement Administration. Sen. Norman Coleman (R-Minn.).

Where is the input from patients/consumers, physicians/nurses/pharmacists, family members, etc.?



Thursday, July 22, 2004

More on Military Menses

Speaking of menstrual periods and the Army, from an illuminating study on the attitudes and knowledge of Pill use for period control among military women:

- 86% desired temporary period suppression during field training

- 83% wanted period suppression during deployments

- 54% didn't know that the Pill can be used to suppress the [fake] period

- only 7% have used period control during deployment

The study concludes:

Although a significant number of soldiers desire OCP-induced amenorrhea [Oral Contraceptive Pill-induced cessation of bleeding], a large deficit in knowledge exists. Routine education as an Army-wide standard is warranted.

As soon as the book is finished (final draft corrections due in two days!) I'm ready to start teaching soldiers about menstrual management. Now if I can only get those Marines to stop giggling.

Wednesday, July 21, 2004

I Have the Power

What is the first thing that comes into your mind when you think of Marines? Perhaps: strong, well-trained, courageous (maybe even fearless), professional. In short, men not to be trifled with. Well, let me tell you: I have found these men's Achille's heel. And, in doing that, I have come to the conclusion that I hold immeasurable power over the United States Marine Corps.

One group of women who can greatly benefit from using menstrual management is women in the military. While fact-checking some military-related terms for my book, I spoke (on more than one occasion) with a male Marine. Mind you, these were Marines from the Public Affairs office, not any old, lowly soldiers.

Without fail, the second I mentioned the title and/or the subject of my book (the menstrual period), the Marines, these mighty warriors, started giggling. That's right. Just by mentioning the period, I have the power to reduce the Marine Corps to a bunch of giggling school girls (er, actually boys in this case). Why is that? I have no idea. The closest parallel I could think of is women's reaction when the subject of the prostate gland comes up. However, to the best of my recollection, I can't think of one instance when the prostate was mentioned in the presence of a woman and she started giggling uncontrollably.

On a more serious note, when I wrote the book I thought all I had to do was educate people about menstrual management. I see now that, before I can even approach that subject, I have to go back to basics. As in: there's nothing embarrassing/mysterious/taboo about the menstrual period. The period is simply a body function. Granted, an exclusively female function, but still a process that needs to be explored and discussed in order to be understood.

Update: Make sure to check out this feministing post.

Monday, July 19, 2004

Natural Family Planning, Part II

A bit more about the Natural Family Planning (NFP) group of birth control methods mentioned in my last NFP post.

What are the NFP methods?

1. CONTINUOUS ABSTINENCE

2. OUTERCOURSE

3. COITAL TECHNIQUE

4. FERTILITY AWARENESS METHODS (FAM)

5. LACTATIONAL AMENORRHEA (Breastfeeding)

How do NFP methods work?

The methods in this group work by relying on sexual techniques (continuous abstinence, outercourse, and coital technique), fertility indicators (fertility awareness methods), or breastfeeding (lactational amenorrhea) to prevent pregnancy.

The sexual technique methods prevent insemination (the deposition of sperm in or near the vagina). The man avoids ejaculation, or ejaculation in or near the vagina.

The fertility awareness methods prevent insemination (or fertilization). First, you identify the fertile period of the monthly cycle with the aid of fertility indicators. Second, you either abstain from sexual intercourse (periodical abstinence) or you use a back-up method during that period of time.

The lactational amenorrhea method prevents ovulation by taking advantage of the hormonal changes that happen during breastfeeding.

In this post, let's take a closer look at the sexual technique methods.

Review of sexual technique methods.

• Continuous Abstinence

This birth control method relies on sexual behavior to avoid pregnancy. It involves complete and continuous abstinence from any form of sexual activity. Obviously, since no sexual activity occurs, insemination is prevented.

The 1st year failure rate is 0% with perfect use. The typical-use rate is unknown.

• Outercourse

This birth control method also relies on sexual behavior to avoid pregnancy. It involves complete avoidance of vaginal-penile intercourse and engaging only in other types of sexual activity (mutual masturbation, oral intercourse, frottage [body rubbing], etc.). Because ejaculation does not occur in or near the vaginal area, insemination is prevented.

There are no published studies on this method's efficacy.

• Coital Techniques

The methods in this group rely on correctly performing a sexual technique to avoid pregnancy.

Coitus Interruptus (CI)

"Interrupted" vaginal-penile intercourse is the main method in this group. Other names used for this method: withdrawal or "pulling out". CI requires the man to withdraw his erect penis from the vagina just before he is about to ejaculate (climax). He then ejaculates outside of the vagina (ideally, as far away from the woman's external genital area as possible). Because sperm is not released in or near the vagina insemination is prevented.

The 1st year failure rate is 4% with perfect use, and 27% with typical use.

Coitus Reservatus (Coitus Prolongatus)

"Reserved" or "prolonged" intercourse requires the man to consciously try to refrain from ejaculating altogether. The penis is maintained erect in the vagina for the duration without ever ejaculating. The act of intercourse ends with the spontaneous or induced flaccidity of the penis (loss of erection), without ejaculation ever taking place at all, inside or outside the vagina.

This is in contrast to CI (withdrawal) where the erect penis is withdrawn from the vagina and ejaculation does take place, away from the vaginal area.

Coitus Obstructus

"Obstructed" intercourse is a sexual technique in which the flow of the ejaculate is directed inward (inside the man's body) rather then outward (in or near the woman's vaginal area). Right before ejaculation, either the man or the woman obstructs the flow of semen through the urethra (by squeezing the base of the penis, or by firmly pressing the area between the scrotum and the anus [perineum]). This forces the semen from the ejaculate to flow back and enter the man's urinary bladder (where it is destroyed and excreted in urine).

Next installment: Fertility Awareness Methods.

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Friday, July 16, 2004

Natural Family Planning (NFP)

The best way to understand CycleBeads, a fertility awareness birth control method that is part of the Natural Family Planning (NFP) group, is to look at it in the context of all the other NFP methods.

I don't have time at the moment to review each method, but here's a list of all the NFP methods. I'll add more information as time permits. [ETA: Natural Family Planning II, and III.]

1. CONTINUOUS ABSTINENCE

2. OUTERCOURSE

3. COITAL TECHNIQUE

Coitus Interruptus (Withdrawal)
Coitus Reservatus
Coitus Obstructus


4. FERTILITY AWARENESS METHODS (FAM)

a) Calendar Method

Rhythm (Ogino-Knaus)
Standard Days Method (SDM)
CycleBeads




b) Basal Body Temperature (BBT) Method

(Bioself 110/Mini-Sofia, LadyComp/BabyComp, Cyclotest-2)


c) Ovulation Method

Billings Method (Cervical Mucus)
Creighton Model
TwoDay Method


d) Cervical Changes Method

e) Sympto-Thermal Method

f) Personal Hormone Monitoring Method
Persona


5. LACTATIONAL AMENORRHEA (Breastfeeding)

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Test 
 


GyneFix
 

Good Old Chocolate
 
Today I wanted to share with you an example of the law of unintended consequences: how brainstorming about promotional ideas for the book made me realize that very few in the consumer industries will benefit from women managing their menstrual periods. However, once I logged in to compose the post I noticed that the control panel had changed. Among the new things, an "upload image/file" icon--lovely! So now I can hardly wait to regale you with pictures of birth control methods. Before we get to that, here's a quick summary of my insight. 
 
The basic point of the book is that women are quite capable of making decisions that will benefit their lifestyle and health. All they need is complete and correct information and they can take it form there.
 
The book deals with menstrual management--a tool that allows you to decide whether to have a period, when, and how often--and with how you can determine if controlling the period can benefit your particular needs. So, what better way to promote the book than with a practical gift giveaway. For example, what product would a menstruating woman find useful?  Three items spring to mind: sanitary products, OTC pain meds, and chocolate. (Well, the last one didn't so much spring to mind as it came into focus by a process of elimination. But I'm getting ahead of myself.) The way I envisioned this was to connect with the manufacturer of one of these products and arrange for free samples. Everybody wins: women get something they can use, the manufacturer gets its product into the hands of users, and women become aware that there's a practical book on menstrual management. And, of course, peace and harmony immediately break out all over the world. Not quite.
 
Upon further reflection, I realized that there might be a minuscule flaw in my plan. According to an industry report
 
The $1.9 billion sanitary protection market has experienced steady growth from 1996 to 1999, but declined in 2000 and 2001, though the number of viable female consumers has increased over that period. The market, which includes only sanitary pads/napkins and tampons, has very little room for growth, and growth in one segment of the market is usually at the expense of the other.

Available studies indicate that women, once they learn that they're able to control how often to have a period, will choose to have fewer periods. For example, a 1977 British study found that 82% of women wanted to have their period every three months, while in a 2002 U.S. poll, among women aged eighteen to forty-nine years, 44% would prefer to never have a period, and 21% preferred a period less frequently than once a month. (Women who wanted to have a monthly period: 29%.) Also, a recent survey of women in China, South Africa, Nigeria, and Scotland found that most women would opt to bleed only once every three months, or not at all. The exception--a majority of Nigerian women who'd prefer to bleed monthly. (Surprisingly, these Nigerian women where also the ones most likely to consider using a birth control method which completely stopped monthly bleeding.) 

Clearly, women having fewer periods and spending less on sanitary products isn't likely to be viewed as a favorable development by the manufacturers of these products. Although, interestingly, how much a particular woman will actually save depends on which menstrual management regimen she use, her health insurance plan, and the area she live in, among other things. For example, if you have a [fake] period only once every 7 weeks your yearly spending on feminine hygiene products is almost half that of a woman who has a monthly [fake] period: $17.54 vs. 41.45 per year. On the other hand (assuming an average use of 18 tampons per month), if you use the Pill for a trimonthly regimen (you have a [fake] period only once every three months), this regimen is cost effective only if the cost of a pill pack to you is $9.45.

Moving on to pharma and OTC period relief meds (and even some prescription ones like Prozac and Zoloft), these products have sales of several hundred million dollars per year. Since one of the benefits of menstrual management is a reduction in period-related problems, like discomfort, cramps, and headaches, I don't think the manufacturers will be overly enthusiastic about a book that allows women to cut down on the use of these products.

Which brings us to the only useful option left, chocolate--the one product whose continued sales don't depend on keeping women uninformed. Fortunately, period or no period, everybody can enjoy a piece of fine Belgian chocolate. So, there you have it. I have found the ideal book gift companion. And that's not all. In keeping with Virginia Postrel's advice about substance and style, my new find will delect both gustatorily, as well as visually. (As soon as I have this all worked out, I'll post pictures so you may judge for yourself.)

And speaking of pictures...the first installment of birth control pictures: Intrauterine Devices (IUDs)

Oh, but of course, I got stuck at the "Upload path" step! Allow me to go figure this out and I'll be back with pics.

Update: Even with this new console, you can only post pictures if they're already hosted online.

 


Thursday, July 15, 2004

New York, New York

Via Amy Langfield and Howard Sherman I found this:

The true New Yorker secretly believes that people living anywhere else have to be, in some sense, kidding. -- John Updike

I must say, based on my observations, this is spot on.

Wednesday, July 14, 2004

Fetal and Infant Mortality

From the report on Racial/Ethnic Trends in Fetal Mortality -- Unites States, 1990-2000:

--in 2000, fetal deaths accounted for almost half (49%) of all perinatal deaths

--singleton (one fetus) deliveries accounted for 91% of all fetal deaths in 2000

--from 1990 to 2000 early fetal deaths increased (from 27% to 34%) across al racial/ethnic groups (except American Indians/Alaska Natives and Asians/Pacific Islanders); late fetal deaths decreased (for all racial/ethnic groups)

--the increase in early fetal mortality was not restricted to earlier, and thus less viable, gestations (fetal mortality rates, calculated separately for fetal deaths at 20-23 and 24-27 weeks, showed no improvement for either group)

Here are some of the raw numbers:

In 1990, of 69,737 perinatal deaths reported, 29,345 (42%) were fetal deaths; of these, 12,554 were early fetal deaths, and 16,791 were late fetal deaths. In 2000, of 54,964 perinatal deaths reported, 27,003 (49%) were fetal deaths, including 13,497 early fetal deaths and 13,506 late fetal deaths.

An editorial accompanying the report notes that:

Trends in the risk for early and late fetal death suggest that changes in perinatal technologies (e.g., fetal imaging, prevention of perinatal infections, effective treatment of maternal medical conditions such as diabetes and chronic hypertension, and more aggressive management of labor and delivery)[6] might have had more of an impact on fetal survival at later rather than earlier gestational ages. In addition, rates of prenatal-care use increased substantially during the 1990s,[7] and the subsequent improved access to care also might have had more impact on late rather than early fetal mortality (e.g., through the detection of maternal, fetal, or placental abnormalities that might lead to a live-born delivery). The lack of progress in reducing fetal mortality at earlier gestational ages might be related to 1) poor understanding of the factors associated with premature delivery and 2) limited understanding of the causes of fetal death and the role of maternal, fetal, and placental pathology.[8]

Fetal death = an involuntary loss in which the fetus showed no evidence of life (i.e., no heartbeat or respiration) on delivery

Infant death = the delivery of a live-born infant who subsequently died by age 1 year

Perinatal deaths = fetal + infant deaths (i.e., >/=20 weeks' gestation to age 1 year)

Early fetal deaths = 20-27 weeks' gestation

Late fetal deaths = >/=28 weeks' gestation




Monday, July 12, 2004

Implants and Intrauterine Devices (IUDs)

Two very good questions: is Norplant still available, and what about IUDs?

Implants

What is an implant?

An implant is one of the six types of hormonal methods of birth control. Implants come in the form of one/several small plastic rods, or a capsule which are inserted under the skin (of the arm, usually).

Each rod has a small amount of only one hormone, a progestin.

The number of rods, and the amount and type of progestin depend on which brand of implant you use. The rods are inserted and removed by medical personnel. Used since 1983, implants are widely available worldwide, except in the United States. Unfortunately, in 2002 Norplant, the only implant available in the U.S., was withdrawn from the market. (Yet, another entire class of birth control methods unavailable to American women. These would be the same women that most of these methods are tested on to begin with, a "minor" detail of course. But I digress.)

The five implant brands are:

1. Norplant: this is the original 6-rod implant; it can be left in place for up to five years

2. Jadelle (Norplant II): this is a 2-rod implant; it can be left in place for up to five years

3. Implanon: this is a single-rod implant; it can be left in placed for up to three years

4. Nestorone: one type consists of a single rod that lasts up to two years, while another type is a small capsule that lasts for six months. The six-month system is available in Brazil under the brand name Elcometrine. It is used to treat endometriosis.

5. Uniplant: this is a single-rod, one year implant (not available commercially).

In general, if you've been using Norplant and you'd like to continue using an implant, the best alternative is one of the newer brands, like Implanon or Jadelle. Of course, just because implants aren't available here, doesn't mean you have to go without. You have two options. If you're planning to travel outside the country, for example to Europe (or anywhere else for that matter), you can have the implant inserted there. Or, you can ask your Ob/Gyn to order the implant directly from the manufacturer. Just make sure he/she is familiar with the method, and is willing to accommodate your needs (there's quite a bit of paperwork involved).

Moving on to intrauterine devices (IUDs), what is an IUD? It is a small device that is inserted inside the uterus, and it's classified as a separate class of birth control. However, there is some crossover: hormone-releasing IUDs can be grouped together with the hormonal methods of birth control. Many types and brands of IUDs are available. Er, that is if you happen to live outside the U.S. In the States, only two brands are available: ParaGard and Mirena. Let's review the main groups of IUDs, so you may better understand your options.

IUDs are non-medicated or medicated (copper- and hormone-releasing), and either framed or frameless.

The non-medicated (or inert) IUDs have an inert plastic frame. Most of the older brands are inert: Graefenberg, Ota rings (these were used in the 1920s), Lippes Loop, Dalkon Shield, Saf-T-Coil, Spring coil, Margulies coil, Majzlin spring, Szontagh, Dana-Super, etc. As a rule, inert IUDs can be left in place for decades.

The framed copper-releasing IUD consists of an inert plastic frame (usually in the shape of a "T", "Y", or a "7") to which copper wire is added. Some brands also have silver wire (the ones with "Ag" in their name). Many types of copper-releasing IUDs are available (by 1974 there were over 20 types available; many more have been developed since). These IUDs may be left in place for up to 10 years. Some of the older types (first generation) are: Copper 7 (Cu-7/Gravigard), TCu-200, Copper T, ML Cu-250, Tatum-T, etc. The major second-generation IUDs are the TCu-380A (ParaGard) and the newer, improved version TCu-380S (Gyne T Slimline), Nova T, and Multiload-375 (MLCu-375) standard and SL. Other brands include the Nova-T380, DanaCu, Superlux, and Ombrelle250. The newest types of copper-releasing IUDs are: Cu-Safe 300 (Flexi-T 300), Fincoid-350, and Sof-T.

In the U.S., only one type of copper-releasing IUD is available, an older brand, ParaGard.

The copper-releasing frameless IUD, as the name implies, doesn't have the rigid, or semiflexible plastic frame seen in the framed type. The frameless IUDs currently in use are GyneFix (scroll down for the picture) and GyneFix mini, which consist of six (four) small copper sleeves threaded on a suture string. The upper end of the thread has a knot which serves as an anchor. (The knot is anchored into the top area of the muscular wall of the uterus; this secures the device in place.) The frameless IUD may be left in place for up to 5 years.

Finally, the hormone-releasing IUD is one that releases a hormone (a progestin). The type available in the U.S. is an older, framed brand Mirena (it's been available in Europe for over a decade). Mirena may be left in place for up to five years. Two newer types of hormone-releasing IUDs soon to be available in Europe are the framed Femilis T (ten years life span), and the frameless FibroPlant (three years life span).

Obviously, each type and brand of implant and IUD has its advantages and disadvantages. In order to find the one that's best suited to your unique needs, make sure you go over the details of each group with your Ob/Gyn.

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Saturday, July 10, 2004

Skipping Your Period With a Triphasic Pill, Part I

I've been getting a lot of questions about using a triphasic birth control pill brand and skipping a period. Before we discuss what regimen you use to skip your period with a triphasic Pill brand, let's make sure we're all clear on the differences between the various pill brands.

We'll discuss extended triphasic regimens in a subsequent post.

There are two groups of birth control pills:

A. Nonsteroidal (centchroman)

B. Steroidal (estrogen/progestin)

A. Nonsteroidal Birth Control Pill


This type of birth control pill contains a substance called centchroman.

The pill is taken once-a-week (twice-a-week for the first 3 months of use), the brand names are Centron or Saheli, and its main advantage is that users don't experience the side effects associated with the steroid (estrogen/progestin) pill. Its main side effect is delayed menses (in less than 10% of cycles). Of course, if the reason you're using a birth control pill is to skip your period, this is a feature not a drawback.

In any case, since this pill isn't available in the U.S., let's move on to the other Pill group, the steroidal one.

B. Steroidal Birth Control Pill

Pills in this group contain estrogen and/or progestin. The pill is taken once-a-day, and there are many brand names. More importantly, pills in this group can be further subdivided, based on what type of hormone (estrogen/progestin) they contain.

There are two main types of birth control pills in this group:

B.1. Progestin-only Pill (progestin)

B.2. Combination Pill (estrogen and progestin)

B.1. Progestin-only Pill

As the name implies, these pills have only one hormone, a progestin. A progestin is either a natural or man-made (synthetic) hormone with properties similar to the natural hormone progesterone.

Progestin-only pill brands are divided into "mini" pill brands, and full-dose brands (not available in the U.S.). As a rule, "mini" pill brands come in 28-day packs, and full-dose ones come in 20-day packs.

Progestin-only brands are not your first choice when it comes to skipping your period.

B.2. Combination Pill

These pills have two hormones, a combination of estrogen and progestin.

Combination Pill brands are further subdivided into mono-, bi-, and triphasic; some come in a 21-day pack, others in a 28-day one, and the newer ones, Seasonale and Seasonique, comes in a 91-day pack. Finally, based on the amount of estrogen, brands are classified as very low-dose (15 mcg or 20 mcg), low dose (35 mcg), and high dose (50 mcg).

All the pills in a 21-day pack are active. An active pill is a pill which has hormones. The 28- and 91-day packs have 7 days of inactive or placebo ("sugar") pills. These pills don't have hormones.

The mono-, bi-, and triphasic designation refers to the amount of hormones in the pill pack.

Monophasic

Brevicon

Each active pill in the pack has the same amount of estrogen and progestin. Also, all the active pills are the same color. This color is a different color than that of the 7 placebo pills found in the 28- and 91-day packs.

Biphasic

Mircette

For most brands, all the active pills in the pack have the same amount of estrogen, but two strengths of progestin.

A 21-day biphasic pack has pills of one strength and color taken for seven or 10 days, then a second pill with a different strength and color for the remainder of the cycle.

A 28-day biphasic pack has an extra seven placebo pills of a third color.

For a 28-day brand like Mircette, a pack has 21 pills of one strength [20 mcg ethinyl estradiol (EE)/0.15 mg desogestrel] and color, 2 placebo pills of a different color, and 5 pills with only estrogen, of a different strength [10 mcg (EE)] and color.

Of note, Mircette is one of the few available sequential brands with a shortened placebo interval: 2 days vs. 7 days. The shortened placebo interval has to do with withdrawal bleeding (fake period) which is different from menses (real period). [More on birth control pill brands with no or shortened placebo interval.]

Triphasic

Ortho Tri-Cyclen Lo

The active pills have either the same or varying amounts of estrogen, and varying amounts of progestin.

A 21-day pack has pills with three different colors and strengths. First, pills of one strength and color are taken for five to seven days. Then pills of a different strength and color are taken for the next five to seven days. Finally, a third strength and color pill is taken for the reminder of the cycle.

A 28-day pack (look under triphasics) has an extra seven placebo pills of a fourth color.

So, there you have it. Lots of birth control pill types, and brands. The important thing to remember is this:

To skip a period a monophasic brand is best.

A monophasic combination Pill brand is best because all active pills contain the same amount of hormones. Less hormonal fluctuation, due to the steady hormone levels, means you're less likely to experience nuisance side effects like irregular bleeding (breakthrough bleeding/spotting).

TIP: Regardless of which type of brand you use--monophasic or triphasic--starting an extended regimen at least three months in advance of the time you plan to skip your period allows your body to get used to the new regimen, and minimizes irregular bleeding.

If you use a monophasic Pill brand, to skip a period you take the 21 active pills, discard the 7 placebo pills, and start a new pack right away.

If you use a triphasic Pill brand you have several regimen options. One of them is to use the same regimen used for the monophasic brands--take the 21 active pills, discard the 7 placebo pills, and start a new pack right away. [Note: this regimen is mostly likely to be associated with irregular bleeding.]

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Friday, July 09, 2004

Plan B and the FDA. An Insider's Report

The FDA does not approve over-the-counter (OTC) status for Plan B, and Drs. Charles Lockwood, Chair, Department of Ob/Gyn, Yale U School of Medicine, and Michael Greene, voting members of the FDA's Reproductive Health Advisory Committee, comment:

On May 7, the FDA issued a "Not Approvable" letter in response to Barr Pharmaceuticals, Inc.'s request for OTC status for its emergency contraceptive (EC), Plan B. This occurred despite overwhelming evidence of the product's safety and potential for reducing the number of abortions in the Unites States. As voting members of the Reproductive Health Advisory Committee, we were incensed and deeply disappointed by the decision but not entirely surprised, given the recent track record of the current administration.

Of course, you already knew that. A bit more medical background on Plan B:

[I]t reduces pregnancy rates from 8% to less than 1%, and to 0.4% when used within 24 hours of unprotected intercourse.
Right now the biggest drawback of all the ECs is that they require a prescription. In most cases, that means the woman must schedule an outpatient visit with her physician or make an unplanned trip to the emergency room. Having to contact a provider is inconvenient, expensive, embarrassing, and can prevent or delay a woman from starting the EC, which only increases her risk of an unwanted pregnancy. Despite these obstacles, prescription-based ECs have already reduced the number of induced abortions in the US by an estimated 51,000. Given that there are 3 million unwanted pregnancies and nearly 1 million abortions in this country each year, readily accessible and inexpensive ECs could prevent hundreds of thousands of induced abortions each year.


Now we leave the planet of Sciencia, and move right along into Politica galaxy:

We reviewed an enormous mass of material on Plan B. In two separate votes, the joint committees unanimously agreed 28 to 0 that the data showed the product was safe when used in an OTC setting and wouldn't encourage women to substitute emergency for regular contraception. We then voted overwhelmingly (23 to 4) to approve Plan B for OTC use, a conclusion that was also supported by the FDA's staff.
In an extraordinarily unusual decision, Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research, overturned the recommendations of the joint committee and his own staff in issuing the "Not Approvable" letter. He based his decision on the fact that the sponsor's application contained no data on subjects under 14 and very limited data on the use of Plan B by adolescents aged 14 to 16.


And this is how medical decisions that affect your (and by "your" I mean exclusively women's) health are made:

What was behind this decision? The FDA never asked our committee to consider whether OTC use of Plan B by girls under age 16 should be restricted. During deliberations, the few opponents of approval voiced concerns about whether OTC availability would reduce condom use and opportunities for physicians to counsel sexually active adolescents and would increase risk of sexually transmitted diseases and adolescent sexual activity. Despite these concerns, they voted with the majority (28 to 0) that the data available from actual trials did not demonstrate these effects. Indeed, the FDA does not restrict access to Tylenol because a woman may delay seeking a physician's care for her brain tumor by self-treating her headache.
While we have no objective evidence that Dr. Galson's decision was politically motivated, his arguments mirrored those of more radical elements of the pro-life community. Moreover, the joint committee members know that unprecedented pressure has and is being brought to bear against the FDA approval by a small cadre of conservative congressmen, led by U.S. Representative David Weldon, MD (R-FL). In a press release, he stated, "As a physician, I have witnessed how patients treat themselves at the pharmacy with little knowledge of the potential health risks of their treatment of behavior--particularly sexual activity. Since adolescents are most vulnerable to STDs, anything that would create an enhanced perception of safety regarding this inherently dangerous behavior is bad public policy. It would leave physicians out of the treatment loop and could exacerbate the already epidemic level of STDs, including HIV/AIDS and HPV [Human Papilloma Virus]." Weldon then issued a letter to President Bush, signed by 49 like-minded colleagues. Aside from the obvious paternalism, the congressman's assertions are bereft of data, but not of political implications for an administration desperately trying to hold on to its conservative base.

We find it offensive that religious ideology and partisan politics have been introduced into the decision-making process regarding a public health issue. Those that oppose OTC status for Plan B have taken a position that defies logic. Whether someone is pro-life or pro-choice, how can he or she oppose a measure that would reduce the need for abortions? Moreover, anyone who thinks that maintaining the prescription status of Plan B will somehow stem the tide of teenage sex or increase chastity is hopelessly naive. Rates of teenage pregnancy and abortion have fallen steadily over the past decade, in part, because of increased access to contraception.

Finally, this action is a flagrant example of the intrusion of religious ideology and conservatism activism--enveloped in a thin veneer of pseudoscience--into what should be a scientific and empirical examination of the evidence by an objective, secular, and unbiased expert government advisory committee. Dr. Galson's action is just the latest in a disturbing pattern by the Bush administration of altering the membership or dismissing the opinions of government committees--and if all fails, disbanding them altogether when their conclusions run afoul of partisan political or conservative ideological positions. Regular readers of Contemporary OB/GYN's editorials know that congressional Democrats have stone-walled tort reform. While the Bush administration is our steadfast ally on professional liability, its recent actions on reproductive health issues create a real dilemma for America's ob/gyns come November.


On a happier, technical note, I figured out how to indent. Now if I can only decipher the mystery of posting tables and pictures, I could really delight you with some great pics of birth control methods.

Lockwood CJ, Greene M. Playing politics with women's health: The FDA and Plan B. Contemporary Ob/Gyn. 2004 Jul;49(7):11-15

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Wednesday, July 07, 2004

Ovarian Tissue Transplant

Belgian doctors report the first ever pregnancy in a 25-year-old woman who underwent autologous (her own) ovarian tissue transplant:

Professor Jacques Donnez and his team "have managed to achieve what no other team in the world has yet been able to do - given a young woman, who underwent cryopreservation of ovarian tissue prior to treatment, the gift of pregnancy," the university hospital said in a statement.

The ovarian tissue was removed and cryopreserved (frozen) before she had chemotherapy for Hodgkin's lymphoma. Then the tissue was transplanted back into her body and, after four months, it was fully functional (maturing and releasing eggs). The child was conceived naturally and the woman is now 25 weeks pregnant. (The usual transplant location is under the skin of the abdomen.)

This is not the first time embryos have been produced from transplanted ovarian tissue:

In March this year, Dr. Otkay [a fertility expert at Cornell University] reported the production of an embryo from an autologous heterotopic ovarian tissue transplant. In that case the woman failed to become pregnant.

Very good news, indeed, for reproductive age women who have to undergo cancer treatment. Also good news on the horizon for women who experience other types of reproductive problems: in mice, the ovary appears to produce eggs throughout the female's life; on-going efforts aim to perfect the techniques used for the first human uterine transplant; and postmenopausal women can carry a pregnancy to term (the oldest woman to give birth is a 63-year-old Californian).

At the same time, from an illuminating interview at feministing.com, we find out that Alexander Sanger, Chair of the International Planned Parenthood Council doubts the safety of the combined oral contraceptive pill. It's not a good day when even the FDA (lately, not the most scientifically-driven body when it comes to women's reproductive health) contradicts such a prominent figure as Mr. Sanger. According to the FDA:

In fact, over the years, more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history [.]

One of these days I will get around to telling you the saga of the IUD (the intrauterine device or, as I like to call it, the Cinderella of American birth control). And while we're on the subject, allow me to be the first to nominate the IUD as the "poster-child/method" of what happens when women can't make beneficial health decisions because of lack of information and massive amounts of misinformation.

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