Friday, December 10, 2004

I Embrace Opinion Health Reporting

I don't have too much to say about this New York Observer article (via mousewords) on Seasonale because I'm new to entertainment-type health reports--heavy on opinion, light on facts and practical information. I don't find them very valuable. It's not so much that I don't enjoy reading the writer's opinions, or those of the women featured in the article. We all have opinions [I heard some people even maintain an on-line journal to express them]; they're good for our ego, and, on most occasions, an interesting read. I just think there's too much health education to be done, and misinformation to be corrected, to write a health article devoid of actual information.

In any case, I do have one comment, and a couple of corrections:

"They're very alluring ads," said Barbara Seaman, a veteran women's-health activist who lives on the Upper West Side--and she didn't mean that as a compliment. "Quite brilliant--an innocent young woman who has no idea about the dangers. It's just some sort of crazy male fantasy."

I'm surprised a women's-health activist would have such a patronizing attitude. Just because a woman is young she shouldn't be assumed to be a moron, a hapless innocent who views an ad from the big, bad pharma and without questioning or educating herself further, and devoid of the ability to grasp the concept of a drug's risks/benefits, starts using it.

Ms. Seaman also pointed to higher rates of "breakthrough bleeding"--unexpected periods--that the Seasonale ad acknowledges. "This whole thing is a joke," she said. "You're taking this so you don't bleed, but then you bleed more than people on the regular Pill!" (Seasonale literature claims this side effect tends to "decrease during later cycles.")

Breakthrough bleeding/spotting (BTB/S) is the occasional, irregular bleeding/spotting some women experience while using hormonal birth control (for pregnancy control or menstrual management). It is most common when you first start using a method, and it usually stops after the first 2-3 months of use. Whether you experience BTB/S will depend on the brand, method, and your body.

Think of BTB/S as an "adjustment" bleeding--the bleeding occurs because the body is adjusting to the hormone dosage in the birth control method. Practically, there are two important things you should remember about BTB/S: it causes no ill health effects, and it isn't a sign that something is wrong; it's just a nuisance. [An important one, however, since BTB is one of the main reasons women stop taking the Pill.]

Ms. Seaman's opinions aside, here are the data for Seasonale:

  • Median number of BTB/spotting days per 91-day cycle decreased from 12 days during cycle to 1 to 4 days during cycle four

  • Three fourths of BTB/spotting days were spotting only

  • [The full study article is not free, so I'm going to quote the entire relevant section, and bold the relevant data.]

    Unscheduled (breakthrough) bleeding

    Like all OC products, patients who received the extended cycle regimen reported varying degrees of breakthrough bleeding (BTB). The active treatment duration of each extended cycle was four times the length of the active treatment duration for each conventional cycle (84 days vs. 21 days). Within the extended cycle regimen treatment group, there were fewer days of BTB with each successive cycle from a median of 12 days during cycle 1 to a median of 4 days during cycle 4 (Fig. 3). The onset of BTB also occurred later within each successive extended cycle and was of shorter duration with each successive extended cycle. The median number of days of unscheduled bleeding-only days in each cycle, as well as the percentage of patients reporting unscheduled bleeding in each cycle, decreased throughout the course of the study as depicted in Fig. 1.

    Extended cycle regimen patients initially reported slightly more breakthrough bleeding and/or spotting and bleeding-only than did patients treated with the conventional regimen. By the last extended cycle (cycle 4), breakthrough bleeding was comparable in the two treatment groups. Of the total number of possible days of unscheduled bleeding or spotting days that could be reported (active therapy days: 336 for the extended cycle regimen vs. 273 days for the conventional regimen), a median of 3.6% days on the extended cycle regimen and 2.9% days on the conventional regimen were associated with diary entries of unscheduled bleeding.

    The majority of patients in both treatment groups reported ≤5 days of unscheduled bleeding per cycle. By the end of the study (cycle 4), 41.5% of extended cycle regimen patients reported no unscheduled bleeding and >80% had ≤5 days. The percentage of patients reporting higher numbers of unscheduled bleeding days (≥6) also decreased with each successive cycle of therapy.

    The Observer article continues:

    Dr. Susan Rako, a psychiatrist who authored the book No More Periods: The Risks of Menstrual Suppression, (Harmony, 2003), pointed to studies showing increased cervical-cancer rates for women on birth-control pills (the American Cancer Society's Web site calls this a "very slight potential risk"); the potential for testosterone deficiency, which lowers libido and general metabolic health; and the lack of longitudinal studies on Seasonale.

    In the US, approximately 13,000 women develop cervical cancer and an estimated 4,100 women die from it each year. Cancer of the cervix is easily detectable--through Pap smear, human papilloma virus (HPV) typing, and colposcopy. This type of cancer develops slowly and is relatively easy to treat. The survival rate for the preinvasive stage (carcinoma-in-situ) is >95%; for the invasive stage it's 70% for white women (56% for black women) at the 5 year mark.

    An aside: Sexual behavior--early age at first intercourse and high number of sexual partners--is the major risk factor for developing cervical cancer. Aim to minimize this risk, and use a barrier method consistently.

    For most women, neither using the Pill nor having a monthly menstrual period increases or reduces the risk of cervical cancer. However, HPV, the virus that causes genital warts, is a factor when it comes to cervical cancer.

    The majority of women who develop cervical cancer (94% of women with invasive cancer, and 72% of women with preinvasive cancer) also test positive for HPV.

    In healthy women, there is no overall association between using the Pill and becoming HPV positive. In women infected with HPV, using the Pill for less than 5 years is not associated with an increased risk of cervical cancer. In HPV infected women who had used the Pill for 5 to 9 years, some studies suggest the risk of cervical cancer was increased. This doesn't mean the Pill causes cervical cancer [studies are under way to determine if there's a connection].

    An aside: Good news on the HPV vaccine front:

    [The] HPV 16 ... vaccine was 94% effective in preventing persistent HPV 16 infection and 100% effective against cervical intraepithelial neoplasia (CIN) grades 2 and 3, compared with placebo over 3.5 years. The study included 1,533 women aged 16-23 years who were initially negative for both HPV 16 DNA and antibodies.


    No cases of HPV-related CIN occurred in any vaccine recipient. In contrast, among the placebo subjects, HPV 16-related CIN 1 was found in 12, CIN 2 in 7, and CIN 3 in 6 (one woman had CIN 2 at one visit and CIN 3 at another).

    Back to the Observer article and Dr. Susan Rako [pointing to the] potential for testosterone deficiency, which lowers libido and general metabolic health; and the lack of longitudinal studies on Seasonale.

    Here's the short version on what's wrong with the article's claims about testosterone (T): Women who use the Pill have a lower free T level than non-users. This doesn't mean they have a T deficiency. In women, a testosterone deficiency state has not yet been defined. Moreover, just because the T level is low, doesn't mean the sex drive (libido) is decreases. Can't comment on the "general metabolic health" because I have no idea what that means.

    Here's the long version: Testosterone (a hormone) is produced by the ovaries and, in contrast to the other ovarian hormones (estrogen and progesterone), it's not involved in regulating the menstrual cycle. In women, testosterone (T) levels are much lower than in men. This makes it very difficult to measure women's T levels accurately [but new tests are being developed]. Only about 2% of the total circulating T is active; the rest is bound to a protein called sex hormone-binding globulin (SHBG). Some Pill brands increase the SHBG, which means more T will be bound and less hormone will be available.

    An aside: By decreasing the amount of free T, Pill use is able to help women with acne, excessive hair growth (hirsutism), and polycystic ovarian syndrome (PCOS).

    In men, T determines a man's secondary sexual characteristics (larger muscle mass, deeper voice, hair distribution pattern) and sex drive (libido)--a low T level means a low sex drive. In women, there's no such direct relationship between T levels and sex drive; many factors play a role. [I'm going to briefly quote from the post I linked to.]

    We know that in men (and some postmenopausal women) low levels of androgens create a deficient state called hypoandrogenism, we know the problems associated with this state (e.g., low sex drive), and we know how to treat it (testosterone supplementation). However, in women it's not clear that such a low androgen state even exists.

    This is what two actual experts in this field have to say about the possibility that a T deficiency state exists in women:


    As research continues in this area, especially in the area of assays that accurately measure free T at low levels, our understanding of androgen insufficiency in woman will broaden.


    In summary, FAI [Female Androgen Insensitivity syndrome] is poorly defined and characterized. There are no clear diagnostic criteria. Therapy with androgen has yet to be proved safe and effective.

    Regarding T levels and libido, let me use a couple of studies to illustrate the point. A group of women whose sexual function was impaired (the women reported feeling less sexual excitement and also had lower T levels) was given T to raise its overall level. The increased hormone levels influenced the "mechanical" aspects of sexual function (blood rushed to the vagina), but the women reported no change in their sexual excitement. In other studies, some women who use the Pill reported increased sexual thoughts, whereas others reported that they had reduced sexual thoughts while on the Pill.

    Finally, the issue with longitudinal studies is not clear. Briefly, with this type of study you want to look at an exposed group (e.g., women who use the Pill on the regular regimen and don't have monthly menstrual periods, or women who use the shot and don't have monthly fake periods) vs. a group without the exposure (women who don't use birth control), or at groups with different degrees of exposure (women who use the pill on a regular regimen and have monthly fake periods vs. women who use Seasonale and have trimonthly fake periods). We have decades of these types of studies (the first studies on the trimonthly period regimen are from the 1970s), and, of course, there are ongoing studies.

    So, that's all I have to say about the article. But wait, there's more!

    Because most women are exposed to this type of article [and because I had to run an errand], I decide to embrace opinion health reporting and give it a try. So I did my own unscientific [and terribly clustered, because it was raining and I didn't feel like walking around too long] sampling.

    I went to one apothecary, Winsdor on 6th (chic place, no insurance accepted), and 3 Duane Reade stores (big chain). At Windsor they sell ~1-2 packs/mo, an expected sale volume for a relatively new product at that location, according to the pharmacist. At the small DR also on 6th Ave., they sell ~2 packs/week (8/mo), a medium volume in the pharmacist's estimate. At a newly opened, medium-sized DR on 57th St., the night pharmacist estimated a 2 packs/mo sales volume. Finally, at the large DR store on Broadway they sell ~5 packs/week (20/mo).

    So, what does my sampling tell us about the desired effect [of Barr's advertising], at least among skeptical Manhattanites? Um, not much [and after I ruined my umbrella for you people]. We're missing so much data--control, sample size, etc.--we can't even make an educated guess.

    In the end, it comes down to this. Defining women based on the state of their uterine lining, and infusing the menstrual period with all sorts of mystical attributes (the essence of femininity; the one thing that defines femininity) is detrimental to making informed health decisions.

    The menstrual period is just a body function, and menstrual management is a tool at your disposal. You use period control if and when it benefits your lifestyle and/or health, not because periods are bad, or you should be ashamed of them.

    Bottom line: There are a bunch of perplexed pharmacists in the city tonight. And when I mention at the start of a post that I don't have a lot to say about an article, take that with a grain of salt.

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    At 8:18 PM, Anonymous Anonymous said...

    I'd want to know, for any studies showing increased risk of cervical cancer with hormonal birth control, when the studies were done, and whether they controlled for condom use. After all, pre-AIDS, using hormonal birth control generally meant you weren't using a condom, and therefore could be at more risk for VD. Even post-AIDS, I'd expect some people not to bother with condoms, if they're otherwise on reliable birth control, and think (maybe erroneously) that their partners are low risk for VD.

    Lynn Gazis-Sax

    At 2:04 AM, Blogger Maggie said...

    Um. Wow. It sounds like Ms. Seaman had a bad experience with Seasonale. But geez.

    I tried Seasonale myself, and for the first 45 days I was on it, it was wonderful. I started it to get rid of "21 days of rage and 8 days of bleeding", and it was great! PMS, depression and mood swings disappeared, my skin cleared up, and YAY, no period! But then I started spotting. Then flat out bleeding. Fifty-two consecutive days of alternating spotting and bleeding kinda sucked, so my doc switched me to LoOgestral, and that's working out just fine, but I'd really rather not deal with a period at all anymore.

    What's your take on Librel, menitoned in the article?

    At 8:10 PM, Blogger ema said...

    Not medical advice, just information. If one starts bleeding while on active [Seasonale] pills: 1) stop the pills, take 5-7 days off, restart; or 2) continue taking active pills, without placebo week x 2-3 cycles; or 3) use an add-back regimen (your MD can tell you more about this, but basically it involves taking a higher dose for a bit, to stabilize the uterine lining and stop the spotting/bleeding). With the new brand, talk to your MD about maybe gradually reducing the placebo interval (say, down to 3 days x several cycles), and then eliminating it, to see how you tolerate that.

    My take: it's basically the same thing as Seasonale--old concept, new packaging. I haven't seen the results of the studies, so I can't comment [I'll post them when they become available].

    I can tell you that a study* that looked at women using an extended regimen (6 months, so only 2 bleeds/year) found that total bleeding days were fewer (25.9 vs. 34.9 in women using the 3 on/1 off regimen), and that women reported significantly fewer bleeding days (18.4 vs. 33.8), bloating days (0.7 vs. 11.1), and menstrual pain (1.9 vs. 13.3)

    *Kwiecien M, Edelman A, Nicholas MD, etc. Bleeding patterns and patient acceptability of standard or continous dosing regimens of a low-dose oral contraceptive: a randomized trial. Contraception. 2003;67(1):9-13.

    At 9:23 PM, Anonymous Anonymous said...

    This was posted quite some time ago, but I just came across it. I want to say that someone who takes the time to do this is just amazing. Thank you, it was very informative....


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