I Offer Marketing Advice to Wyeth Via a NYT Critique

The New York Times has an article about extended and continuous use Pill brands, Pill That Eliminates the Period Gets Mixed Reviews.

Pretty much everything in the article is wrong, including the title.

A bit of background, first. Seasonale, Seasonique, and Lybrel are extended/continuous use combination birth control pills. Like regular Pill brands, Seasonale, Seasonique, and Lybrel eliminate the menstrual period for the entire duration of use. Unlike regular brands, extended/continuous use brands also decrease the frequency of, or altogether eliminate (Lybrel), the monthly withdrawal bleeding episode.

Again, the difference between regular pills and extended/continuous use ones is not the presence or absence of a monthly menstrual period. All pills are designed to eliminate periods for as long as a woman takes them. [Keep this in mind the next time you hear or read that Seasonale enables women to have only four periods per year.] The difference is that Seasonale, Seasonique, and Lybrel, on top of eliminating the period, also mostly/altogether do away with the monthly withdrawal bleed.

The monthly menstrual period and the monthly withdrawal bleed are not one and the same thing. They are distinct, unrelated events.

The monthly period is the body-directed shedding of a thickened uterine lining, under the influence of fluctuating endogenous hormone levels, at set intervals (~21 days). The monthly withdrawal bleed is the user-directed artificial destabilization of a thin uterine lining, as a result of deliberately manipulating the dosage of exogenous hormones in the Pill, at arbitrarily set intervals (21 days, 49 days, 84 days, 168 days, or 336 days).

A monthly menstrual period has a [single] biological purpose: to prepare the uterine lining for pregnancy. A monthly withdrawal bleed has no physiological or biological purpose. It's a designer trick, intended mostly to appease politicians and Popes. It's a historical artifact, not a biological requirement.

Now, let's look at the article.

For many women, a birth control pill that eliminates monthly menstruation might seem a welcome milestone.

To women living in the 1950s, perhaps. But since a birth control pill that eliminates monthly menstruation has been in wide use since the 1960s, the shine is off the milestone bloom.

And speaking of over half a century ago, did you know that initially the Pill was submitted to the FDA in 1957 as a treatment for menstrual disorders, and only later, in 1960, as a method of pregnancy protection?

But others view their periods as fundamental symbols of fertility and health, researchers have found. Rather than loathing their periods, women evidently carry on complex love-hate relationships with them.

Some women view their periods as symbols of fertility and health. Others don't. Ergo, those who don't...wait for it...loath their period. You don't say. Also, the fact that different women view their period differently isn't evidence of women carrying on a complex love-hate relationships with their periods. Rather, it's evidence that women are sentient beings who don't all hold the same view on this one particular topic.

This ambivalence is one reason that a decision expected next month by the Food and Drug Administration has engendered controversy. The agency is expected to approve the first contraceptive pill that is designed to eliminate periods as long as a woman takes it.

Please, for the love of the FSM, people [and by "people" I mean NYT reporters] pay attention; this is a very simple concept:

Every single one of the Pill brands in use, from the 1960s to today, is designed to eliminate periods for as long as the woman takes the pill. The first contraceptive pill designed to eliminate periods as long as a woman takes it was submitted for FDA approval in 1957.

What the FDA is expected to approve, is Lybrel, the first pill designed to eliminate the monthly withdrawal bleeding episode for the entire duration of use.

"My concern is that the menstrual cycle is an outward sign of something that’s going on hormonally in the body," said Christine L. Hitchcock, a researcher at the University of British Columbia. Ms. Hitchcock said she worries about "the idea that you can turn your body on and off like a tap."

That viewpoint is apparently one reason some already available birth control pills that can enable women to have only four periods a year have not captured a larger share of the oral contraceptive market.

"It’s not an easy decision for a woman to give up her monthly menses," said Ronny Gal, an analyst at Sanford C. Bernstein & Company.

First, already available extended use Pill brands, like Seasonale, do not, in any way, shape, or form, enable women to have four periods a year. Women who use Seasonale (or, for that matter, a regular Pill brand, or Seasonique, or Lybrel) do not have menstrual periods for the entire duration of use. Zero periods.

Seasonale, Seasonique, and Lybrel have no effect on the frequency of your menstrual period because you don't menstruate when you use the Pill. All these brands do is to decrease the frequency of, or eliminate (Lybrel), the monthly withdrawal bleed.

Second, I agree that ignorance--just like Ms. Hitchcock and Ronny Gal, many people aren't familiar with the basics of menstruation or the difference between a monthly period and a monthly withdrawal bleed--tends to act as a barrier to women making informed health decisions. The way to combat this problem is to educate as many people as possible about all matters menstrual. Starting with uninformed researchers and analysts quoted in the NYT, and the reporters who interview them.

Third, maybe a fine point, but one you should be familiar with if you're a NYT reporter. If you're attempting to gain insight into why women use, or don't use, extended/continuous Pill brands, women who express reservations about not having a monthly period are not your go-to group. Since these women want to have a period, they're not candidates for the Pill, regular or otherwise. Their viewpoint might tell you why some women don't use the Pill, but it won't tell you much about why women who don't mind eliminating their monthly period use, or don't use, an extended/continuous Pill brand.

Doctors say they know of no medical reason women taking birth control pills need to have a period. The monthly bleeding that women on pills experience is not a real period, in fact.

Ugh, no, doctors most certainly do not say something this nonsensical. What they do say is that there's no known medical reason for women taking birth control pills to have a monthly withdrawal bleed. You know, that thing that women on the Pill experience and which is not a real period, in fact.

And studies have found no extra health risks associated with pills that stop menstruation, although some doctors caution that little research has been conducted on long-term effects.

One more time. All Pill brands stop menstruation for the entire time you take the pill. Millions of women have been using the Pill since 1960. It is now 2007. That's 47 years. According to the FDA:

[O]ver 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....

Oh, and since this is supposed to be an article about pills that stop the monthly withdrawal bleed:

The earliest such study, conducted by Loudon et al. in 1977, reduced the withdrawal bleed frequency to once every 3 months (84 days of continuous pills) in 196 women using a combination OC containing 50 μg EE [estrogen] and 2.5 mg lynestrenol [progestin]. Overall, 82% of women were satisfied with the regimen, which was associated with decreased menstrual and premenstrual symptoms. Many women also missed fewer pills on the extended regimen.

Ms. Chesler, who teaches documentary making at the University of California, San Diego, said she became concerned about efforts to eliminate menstruation when she first heard about the idea several years ago.

"Women are not sick," she said. "They don’t need to control their periods for 30 or 40 years."

Efforts to eliminate menstruation have been on-goingWomen have been using the Pill since the 1960s and Ms. Chesler only heard about it a few years ago? Ah well, better later than never.

And to be clear, the only person saying that healthy women need to control their periods because menses represent some sort of sickens is none other than Ms. Chesler. Projecting much?

The menstrual period is just a body function, and the option to control it is just a tool at your disposal. If you're healthy, you don't *need* to control your period, but you might very well *want* to, not as a way to get rid of Teh Sick, but because it benefits your lifestyle.

The subject has also ignited a debate within the Society for Menstrual Cycle Research, a scientific organization that studies both the medical and social science of menses.

In 2003, the group issued a position statement saying that more research was needed before women could make an informed choice about using pills that suppress their periods.

How hard is it to find a scientific organization familiar with the topic under discussion? Like the fact that all Pill brands suppress the period? Or the fact that women have been using pills that suppress their periods since the 1960s? Or even the fact that the Pill is one of the most studied drugs in the FDA's history? Just because an organization has the words "Menstrual Cycle" and "Research" in its title doesn't automatically make it relevant and worthy of a NYT article mention.

Ms. Hitchcock, a director of the organization, said that although some research has been comforting, she remained concerned that medical science did not fully understand the long-term implications of interrupting women’s periods. The same hormones that work on the menstrual cycles act in the brain, bones and the skin, she said.

"You need to think about whether there are consequences we don’t know about for the whole body," said Ms. Hitchcock, who is with the Center for Menstrual Cycle and Ovulation Research.

Pay attention to Ms. Hitchcock people! She speaketh the truth. If only medical science had a way to understand the long-term implications of pregnancy, breast feeding, or decades of Pill use there might be hope to understand the long-term implications of interrupting women's periods.

Oh, and just in case I haven't mentioned this in the last minute or so, according to the FDA, 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.

There has also been a backlash among groups that celebrate the period as a spiritual or natural process, like the California-based Red Web Foundation. "The focus of our group is to create positive attitudes toward the menstrual cycle; suppressing it wouldn’t be positive," said Anna C. Yang, a holistic nurse and executive director of the organization.

Oh, oh, I want to be holistic, too, but apparently I'm not presumptuous enough. Just because you believe having a monthly period is a positive, does not automatically mean suppressing the period is a negative. There are construction workers in the middle of summer, postcall surgeons in the middle of surgery, and stay-at-home mothers in the middle of family life who benefit from period suppression. As are these people:

Many women in the military (>60%) report that menstrual or premenstrual symptoms have affected their ability to perform physical tasks and have created problems with regard to changing, obtaining and disposing of hygiene products....In the United States, tubal sterilization is the most common form of contraception; this large group of sterile women continue to menstruate with no possibility of pregnancy. For all of these women, amenorrhea [no bleeding] through continuous OC use could improve their quality of life.

And just so we're crystal clear [heh, I said crystal. Spiritual enough for you?] on one thing. If you're a modern woman living in an industrialized society, it's perfectly *normal* to have a monthly period. But it's not *natural*; it's not the baseline. For example:

Women 100 years ago began menstruating at the age of 16 years, had their first child at 19.5 years of age and gave birth six times between the ages of 20 and 34 years. As a consequence, they only experienced an average of 160 menstrual cycles during their lives. Modern women begin menstruating much earlier, at an average age of 12.5 years, and have fewer children (two children on average in the United States), which translates into more than 450 menstrual cycles over their lifetime.

Eliminating menstruation is not a completely new concept. Women who take any kind of oral contraceptive do not have real periods.

Because the hormones in pills stop the monthly release of an egg and the buildup of the uterine lining, there is no need for the lining to shed — as occurs during true menstruation.

Aha, so eliminating menstruation is not a new concept, and women who take any kind of oral contraceptive do not have real periods. Moreover, they don't need to have a monthly withdrawal bleed. Wait, what!?

Haven't we just spent 18 paragraphs reading, over and over again, how:

- a birth control pill that eliminates monthly menstruation might seem a welcome milestone

- the FDA is expected to approve the first contraceptive pill that is designed to eliminate periods as long as a woman takes it

- some already available birth control pills enable women to have only four periods a year

- more research is needed before women could make an informed choice about using pills that suppress their periods

Here's the thing. Having correct information about the period, the Pill's mechanism of action, and the difference between menses and withdrawal bleeding is crucial in allowing readers to critically evaluate the article's claim that extended/continuous Pill regimens are getting a mixed review.

Mentioning this information in the 18th paragraph, sandwiched between inaccurate statements, repeated over and over again, is substandard. It almost looks like something you might do if you didn't have any hard data to support your central claim.

Moving on.

Still, since the advent of oral contraceptives in 1960, birth control pills typically have been designed to mimic the natural 28-day menstrual cycle to assure women using the pill that their bodies were functioning normally.

Still, what? Just because brands have been typically designed to mimic the 28-day monthly cycle doesn't mean you can ignore that (1) all Pill brands suppress menstruation for the entire duration of use, and (2) the menstrual period and withdrawal bleeding aren't one and the same thing.

And if we're assigning blame for the fact that scientists sneaked in a monthly withdrawal bleed in the original Pill regimen, let's not forget two of the main reasons for the deception: blunting politicians' regulatory reflexes [ironic, no?], and groveling for Pope Paul VI's acceptance. As I remarked in a previous post:

Heaping the concept that women could also control their menstrual period on top of their fertility was considered just too much for the political, religious, and societal sensibilities of the 1950s. Enter withdrawal bleeding. By building-in this monthly bleeding episode into Pill use, the scientists hoped to ease the "shock". [Remember, what we're talking about here is a female health issue, something that, apparently by definition and divine law, requires final approval from politicians, religious leaders, and as many self-appointed "protectors of women" as we can find. In the 1950s, unfortunately just like today, giving women all this control over their bodies and their health was inconceivable; decisions about female health issues couldn't possibly be left to the women and their health care professionals.]

The pills are usually packaged as regimens of 21 days of hormone pills and 7 inactive pills. The interruption of hormone therapy during the inactive part of the regimen induces bleeding that resembles a mild period but is, in fact, caused by unstable hormone levels.

In recent years, drug makers have come out with new pill regimens that tinker with the 28-day cycle by increasing the number of hormone pills, creating a shorter span of bleeding.

The drug maker Barr caused a sensation in 2003 by introducing Seasonale, a contraceptive regimen packed as 84 hormone pills and 7 placebo pills. Users have "periods" once every three months.

(emphasis mine)

Actually, the recent innovation is the packaging, not the regimen. Extended use regimens have been in use for decades (granted, in a less elegant format--pill strips cut from separate packs, tied together with a rubber band):

The traditional OC regimen is an artifact of [a] bygone era, rather than a scientifically established truth. Clinicians realized from the beginning that OCs could prevent bleeding as long as they are taken, producing a cycle or interval of any desired length

In any case, let's not lose focus. After many paragraphs, we finally have some accurate information, including that Seasonale users have "periods" once every three months. [As opposed to what we were told before, that some already available birth control pills enable women to have only four periods a year.]

But look at comes next:

And the company plans a direct advertising campaign within the next few months for a newer version, Seasonique, which also reduces periods to four a year.

Um, and which period would that be--the period period, or the "period" period?

Seriously now, for the sake of consistency, if not accuracy, once you managed to presented the correct information to your readers, you should stick with it, instead of reverting back to making inaccurate statements.

Seasonique does not reduce periods to four a year, since women using it do not have periods. What Seasonique does do is shift the frequency of withdrawal bleeding from monthly (regular Pill regimen) to four times a year.

Views about menstruation have long been mixed. Some cultures have banished menstruating women to huts or required special baths after periods. Others believed that menstruating women had special powers.

In her diary kept while in hiding from the Nazis, Anne Frank mused about menstruation. "I have the feeling that in spite of all the pain, unpleasantness and nastiness I have a sweet secret," she wrote.

Wyeth’s research indicates that ambivalence toward the menstrual period continues today. A look at the data reveals that half of the women said they found comfort in their periods as an indication that they were not pregnant. Nearly a quarter of the women polled said they were attached to their periods as a natural part of womanhood.

First, discriminating against menstruating women, or, for that matter, heaping unreasonable expectations on them, does not mean that *women* are ambivalent about their period. [And seriously, using the musings of a poor, traumatized girl, hiding from the Nazis as an example of the "mixed" views women have about their menses? That's just lame.]

Second, just because you don't want to suppress your period--women who wish to rely on their period as an indicator that they are not pregnant; women who view their period as a symbol of womanhood--doesn't mean you're ambivalent towards your menses. All it means is that you hold a different view than women who want to eliminate their periods. [Since we're on the subject, if you want to have monthly periods you are not a Pill candidate. You shouldn't use any Pill regimen--regular (21/7), extended-cycle (84/7), or continuous [336].]

Third, if you want to gain insight into what women think about Wyeth's Lybrel--a new pill that would eliminate the monthly withdrawal bleeding episode--you need to look at relevant data. Data on women who don't have an objection to suppressing their periods in the first place:

When women are allowed to choose their cycle length and duration of pill-free interval, they clearly prefer extended cycles and shorter pill-free periods. Among women who were permitted to set their own hormone-free intervals (n=220), most (60%) continued using extended cycles for more than 2 years, with 88% choosing a hormone-free interval of ≤4 days, with no serious sequelae or pregnancy.

The currently available medical research shows that the side effects of pills that suppress menstruation are the same as the side effects of regular birth control pills. The risks are generally low, but the most significant risk is cardiovascular problems in women who smoke, the reason that pills are packaged with a warning not to smoke.

Since pills that suppress menstruation and regular birth control pills are one and the same thing, what we learn from the NYT is that the side effects of the Pill are the same as the side effects of the Pill. Wow, that's powerful dude!

OK, one last time (in a different format for a change):

- Regular Birth Control Pills (x) and (y)
- Pills That Suppress Menstruation (x) and (y)/(z)
- Seasonale/Seasonique/Lybrel (x) and (z)

where x = suppression of menstrual period for duration of use
y = monthly withdrawal bleed
z = trimonthly/no withdrawal bleed

Now, it's quite possible that what the NYT reporter meant to say was that the currently available medical research shows that the side effects of pills that reduce the frequency of, or altogether suppress, the monthly withdrawal bleed are the same as the side effects of regular birth control pills. For example, this:

Since the early days of OC use, studies about reducing the number of pill-free periods have shown that it is a safe and effective option for many women....A recent study reexamined the extended 3-month cycle with a lower dose formulation (30 μg EE/150 μg levonorgestrel; Seasonale®, Barr Laboratories, Pomona, NY) in 682 women and found similar efficacy and safety to a 28-day cycle.

And this:

A recent review* evaluated the differences between cyclic (21-day) and continuous use (>28 days) of OCs. Due to the significant differences between published studies, the authors were unable to perform a meta-analysis; however, the authors concluded that the available evidence suggests that continuous use of OCs offers comparable contraceptive efficacy and safety to cyclic OC regimens. Bleeding patterns were either similar or improved with continuous OC use. Where evaluated, the incidence of cycle-related symptoms (such as headaches, tiredness and menstrual pain) was reduced with continuous OC regimens.

But some doctors caution that there is no data on what happens when menstruation is suppressed for a very long time.

"We don’t have any long-term studies for what happens if you stop periods for years and years and years," said Dr. Maria Bustillo, a reproductive endocrinologist in Miami. Dr. Bustillo said there was probably no increased risk over traditional birth control regimens, but added that the "jury is still out" on whether breast cancer risk might be increased.

Although studies are conflicting, some have shown that the birth control pill may increase that risk. According to the National Cancer Institute, research indicates that the pill increases the risk of liver cancer in otherwise low-risk women while decreasing the risk of cancers of the ovary and the endometrium — the lining of the uterus.

(my link)

We don’t have any long-term studies for what happens if you stop periods, other than all those studies that make the Pill--a drug which stop periods for years and years and years--one of the most studied medicines in history, right?

In any case, the point is that everything from the "jury is still out", studies are conflicting, to the lining of the uterus refers to the risks of the regular birth control Pill.

And just to be accurate, briefly:

Use of combined OCs is associated with a decreased risk of cancers of the endometrium and ovary and an increased risk of cancer of the cervix and liver, a small increased risk of breast cancer in young women and a decreased risk of colorectal cancer. However, there is great uncertainty regarding the causal link, if any, between combined OC use and liver and colorectal cancer, and recent evidence suggests no association between current or former combined OC use and breast cancer. Regardless, the net effect of pill use on cancer is negligible.

With Barr’s Seasonale and Seasonique, the biggest medical problem so far — one that has also cropped up in tests of Wyeth’s Lybrel — is that users can have unpredictable and irregular bleeding or "spotting" that is worse than with regular birth control pills. But for some women who view their periods as the natural order of things, the qualms go beyond purely medical concerns.

...

One [woman] who attended the screening [of Ms. Chesler’s documentary "Period: The End of Menstruation?"], Aviva Bergman, a 22-year-old student at Goucher College in Maryland, said she would not use products that suppressed her period because it seemed unnatural.

"I just feel that there’s a reason you’re getting it every month," she said.

First, unpredictable and irregular bleeding or spotting (breakthrough bleeding, or BTB) is common with both regular and extended/continuous Pill use. The good news is that BTB is a nuisance side effect. The bad news is that, when it cames to the regular Pill, it's a major reason women discontinue use. [There are ways to minimize BTB. If you experience BTB don't suffer in silence. Ask your Ob/Gyn for help.]

Second, with both extended and continuous use, BTB tends to be slightly worse during the first few months of use only.

Third, the problem of focusing on a non representative group when discussing women's views of extended/continuous Pill regimens crops up once again. Women who view their periods as the natural order of things are not Pill candidates, and should not be using this birth control method. You cannot tell how women view eliminating the monthly withdrawal bleed by looking at women who object to using the Pill in the first place.

Finally, regarding there’s a reason you’re getting your period every month. Indeed there is. Menstruation has a single biological purpose; to prepare the uterus for a pregnancy. That's it.

Bottom line: If you're a NYT reporter writing an article claiming that extended/continuous use Pill brands are getting a mixed review, you need to (a) insure that your medical facts are correct, (b) use correct facts consistently, throughout the article, and (c) back up your claim with relevant data and quotes from informed experts.

PS And if you're Wyeth and you want to insure solid sales for Lybrel, call me you need to make sure women have complete and correct information about the menstrual period, withdrawal bleeding, and the Pill's effect on these events.



[*Edelman AB, Gallo MF, Jensen JT, Nichols MD, Schulz KF, Grimes DA. Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2005;CD004695.]


(via Women's Health News)