Long-Term Reversible Birth Control

This should be emblazoned all over the place:

Reproductive-age women have varying contraceptive needs...[T]he method of contraception must be tailored to meet the needs of the individual.

Three long-term birth control methods (.pdf)--ParaGard (copper IUD), Mirena (progestin-releasing IUD), Implanon (contraceptive implant)--three case studies, and three experts. Read the whole thing.

Where We Hear From the NY Post And We Are Left Wondering What It "All" Means...Er, "Means"

After noticing several factual inaccuracies about Plan B in a NY Post op-ed, I emailed the columnist:

Ms. Wisse Schachter,

I'm contacting you to alert you to a number of factual mistakes in your op-ed. Briefly:

--Plan B is the "emergency contraception pill[s]", or the "postcoital pill[s]", not the "morning-after pill". [That's an incorrect and misleading term.]

--Plan B is not a pill, it's two pills. Two 0.75 mg levonorgestrel pills, to be exact. [Essential information in view of the new dosage recommendations.]

--Plan B is not basically a double dose of the regular birth-control pill. [Even without defining "regular birth-control pill", Plan B is neither a double dose of the regular progestin-only pill, nor of the EC regimen combination one.]

--Plan B is not associated with "cardiovascular disease, high blood pressure, blood clots, heart attack and strokes." (For that matter, neither are the COC EC regimens.) [In fact, Plan B is the preferred EC method for patients with a history of blood clots or stroke.]

(Full post here.)

Thank you for your time.

ema

Today, Ms. Schachter emails back:

Dear Ema,

Thank you for your message and for taking the time to read and respond to my op-ed.

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

It would have been nice had taken as much time reading the column as you did "rebutting" it.

Regards,
Abby Schachter

First, I appreciate the response.

Second, allow me to address this:

It would have been nice had taken as much time reading the column as you did "rebutting" it.

People, as a rule, when emailing me, assume I'm dense and just say what you mean. Not having to divine intent saves me a lot of time.

I'm not sure, but here's what I think Ms. Schachter's admonition means--"I write a piece focused on the political and social implications of OTC availability of Plan B, and you 1) don't address those issues at all, and/or 2) refute them [not] by pointing out, and correcting, the factual mistakes about Plan B." Correct and incorrect at the same time.

Correct, because all I did was address the factual mistakes about Plan B--what it is, it's side effects, etc. My position (and concern) is that, unless we know the basics about a drug, we cannot have an informed discussion about the politics surrounding it.

Incorrect, because, by pointing out the mistakes about Plan B, I was not rebutting anything; I wasn't presenting any opposing evidence to Ms. Schachter's opinions. The facts about Plan B, like its progestin-only content, are not up for debate. It's not a "she said", "she said" situation. We don't each get a few minutes to make our case. Plan B's composition, or side effects for that matter, are a given, independent of anyone's argument/counterargument [you know, the "science" part].

Last, but not least, we have this:

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

Here's the thing [yes, I know, I'm watching way too much Monk]: 1) the side effects listed in the piece are not those commonly associated with taking birth control, and 2) there's nothing even remotely clear [not to mention correct] about Plan B's side effects in the piece.

There are seven groups of birth control, and over eighty individual methods:

1. Hormonal Group

-Combination Pill

-Progestin-only Pill

-Skin Patch

-Vaginal Ring

-Implants

-Shots

-[Hormone-releasing IUDs]

2. Nonsteroidal Pill Group

-Centchroman

3. Intrauterine Device Group

-Older IUDs

-Frame IUDs

-Frameless IUDs

-[Hormone-releasing IUDs]

4. Barrier and Spermicide Group

-Condom (male, female, and unisex)

-Diaphragm

-Cervical Cap

-Ovès Cap

-FemCap

-Lea contraceptive

[Good pics here.]

-Sponges

-Spermicides

5. Natural Family Planning Group

-Continuous Abstinence

-Outercourse

-Sexual techniques

-Breastfeeding

-Fertility Awareness

6. Sterilization Group

-Male

-Female

7. Emergency Contraception Group

-Combination Pill

-Progestin-only Pill

-Antiprogesterone Pill

-Progesterone production blocker Pill

-IUD

These are the side effects listed in the op-ed:

...mild, such as dizziness, weight gain and irregular periods. ... more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

Ms. Schachter says these are the side effects (emphasis mine) commonly associated with taking birth control. Since we're talking about common side effects, everything after rare (cardiovascular dz, HTN, blood clots, heart attack and strokes) is out.

So we're left with dizziness, weight gain and irregular periods. According to Ms. Schachter, these are the side effects commonly associated with taking birth control. Really? When's the last time your partner's condom use caused you to gain weight?

Okay, I'm being facetious, but you get the point. There's no such thing as side effects ... commonly associated with taking birth control. That's because a method's side effects depend on group, mode of action, dosage, route of administration, risk factors, etc..

Even if Ms. Schachter was only referring to the Hormonal Group when listing the side effects, it's still essential to be accurate.

Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not common side effects of methods in the hormonal birth control group. They are rare effects of some of the methods--the combination (estrogen + progestin) ones--in this group. [To give you an idea ...even deaths due to rare events, such as accidents or homicides, are much more common than deaths due to OC-related adverse events.*]

Moreover, the Hormonal Group and the EC Group are not one and the same. The side effects associated with combination methods in the Hormonal Group differ from those associated with combination methods in the EC Group. Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not side effects--rare or otherwise--associated with combination (estrogen + progestin) EC regimens. [From my previous post: No deaths or serious complications have been causally linked to emergency contraception.]

Last, but not least, Plan B is a PROGESTIN-ONLY method. Its side effects differ from the combination (estrogen + progestin) methods in the EC Group.

Which brings us to Ms. Schachter's assertion that she made it perfectly clear in her piece that the side effects she lists are commonly associated with (?hormonal/?estrogen-progestin) birth control, in general, not Plan B. I disagree, and here's why.

In a piece

...titled 'PLAN B': What Science Can't Tell Us...

...containing the statement But it plainly is all about Plan B...

...focused on issues surrounding the approval of OTC sales of Plan B...

...stating that OTC approval of Plan B is troubling because women could get it without the benefit of a doctor's warning about side effects...

Well, approval raises a host of troubling questions. For one: Since it's only a double dose of regular birth control, women over 18 (or girls with fake IDs) could get "the pill" without a prescription - or a doctor's warnings about side effects.

...personalizing the issue of lack of physician counseling about side effects, if Plan B becomes available OTC, by quoting an Ob/Gyn's concerns about losing the opportunity to present medical issues associated with OTC sales of Plan B...

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception [that would be Plan B] means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" [again, Plan B] if a woman doesn't have to see a doctor to get it.

(emphasis mine)

...where the above paragraph--about Dr. Roston's worries that OTC sales of Plan B would rob her of the opportunity to discuss with women medical issues associated with taking Plan B--is immediately followed by an enumeration of side effects...

Of course, some of the risks are mild, such as dizziness, weight gain and irregular periods. But others are more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

it is not at all perfectly clear that the listed side effects are not those associated with Plan B, but rather those associated with some mythical "birth control".

Bottom line: This is not about Ms. Schachter's opinions on OTC sales of Plan B, or my reading comprehension and/or debating prowess. It's about the duty of a publication like the NY Post to present factually accurate medical information to its readers. Or not; in which case the NY Post should have no objection to publishing my article entitled "Plan B Causes Cooties."


*Dialogues In Contraception. Winter 2002;7(7):4

Skip Your Period and Period Control Options

Good AP article on the available options for period control, as well as some coming attractions.

Among the existing methods:

- Seasonale: 30 μg of estrogen (ethinyl estradiol, or EE)/150 μg of progestin (levonorgestrel), taken continuously for 84 days, followed by 1 week off.

- Ortho Evra patch: 0.75 mg estrogen (EE)/ 6.00 mg progestin (norelgestromin) [20 μg estrogen/150 μg progestin per day], one patch per week for 8 or 12 weeks in a row, followed by 1 week off.

- NuvaRing vaginal ring: 2.7 mg estrogen (EE)/11.7 mg progestin (etonogestrel) [15 μg estrogen/120 μg progestin per day], one ring in place for 3 weeks at a time, for 6 or 12 weeks total in a row, followed by 1 week off. [Alternatively, one ring can be left in place for 4 weeks at a time.]

- Depo-Provera [and Depo-subQ provera 104] shot: 150 mg progestin (medroxyprogesterone acetate) [104 mg progestin], one injection four times a year.

One more existing brand worth mentioning is Loestrin 24 Fe. The innovation here is the shortened placebo interval--one estrogen/progestin pill taken for 24 days, followed by one iron-containing placebo pill taken for 4 days. [Of course, if you're already taking the Pill, and you want a shorter placebo interval, you can use your existing brand to do that. Just take 4 placebo pills, instead of the usual 7, followed by a new pack.]

And some newer developments:

- Seasonique: 30 μg of estrogen [EE]/150 μg of progestin [levonorgestrel]), and 10 μg EE, one estrogen/progestin pill taken continuously for 84 days, followed by one estrogen-only pill for 7 days; no placebo interval.

- Lybrel: 20 μg ethinyl estradiol/90 μg levonorgestrel, one estrogen/progestin pill taken daily with no placebo intervals.

- Implanon*: 68 mg progestin (etonogestrel) [~40 μg progestin per day], one-rod implant lasting up to 3 years.

*Just like so many other methods before it (Mirena, Depo-Provera), Implanon has been available for over a decade outside the U.S.. This pretty much insures Implanon's status as a "cutting edge" method over here.

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.