In Our Control (28 page)

The real problem seems to be the same one we have been struggling to reconcile since the second-wave feminist movement—that is, the sense that women “want it all.” Periods—and more specifically, cultural ideas about premenstrual syndrome—provide a forum for expressing the opinion that if you try to be everything, you will be nothing. Modern women can try to pass as men for most of the month, filling traditionally male roles, but at some point their hormones defeat them. And at that moment they can’t even be good women anymore.

An infuriating message, to be sure. It is on this point, I would argue, that Coutinho and his cohorts are mistakenly but genuinely trying to provide compassionate options for women. These doctors feel that if the signs of menstruation (and although it goes unspoken, presumptions about female weakness) are removed, then no one in a woman’s community—not even the woman herself—can argue that she is unable to capably fill whatever role she would like.

This might seem like a pragmatic solution. But it proposes that instead of addressing the social inequities and generations of negative misperceptions of female bodies, women should instead accept that the flaw is within them. It is a biological solution to a problem that has social, political, and physical dimensions. This does not make room for female empowerment, but rather replaces one type of control (social and political) with another (pharmaceutical).

This is not to deny the reality of PMS as a source of suffering for many women. In an excellent history of PMS since the Renaissance, Michael Stolberg debunks the notion that it is a twentieth-century illness and is therefore purely or even largely a construction of a sexist medical establishment. Stolberg writes that contrary to many claims, “premenstrual suffering was frequently described as a very common complaint by physicians
and women alike,” adding, significantly, “this is far from denying the role of cultural and social influences. Repeatedly, over the centuries, the interpretation and even the very perception and experience of the nature and timing of premenstrual suffering were profoundly reconfigured and transformed.”
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As with menopausal symptoms, such as hot flashes and night sweats, PMS difficulties can range from nonexistent to debilitating. For most women, their period brings nothing more than inconveniences, but a smaller group will find their lives complicated, damaged, or disturbed by them. Diane, a woman in her midtwenties who works for a woman’s health organization, shared her story with me. Growing up in rural Idaho, she suffered each month with almost unbearable pain. Because her family was deeply religious, birth control pills were not an option. When she was finally offered hormonal contraceptives as a solution to period pain, Diane was already in her twenties. “It totally changed my life,” she says. “I don’t like the idea of being constantly medicated, but right now, this makes my pain manageable.”

For this tiny but significant group, menstrual suppression drugs may provide one option for alleviating suffering, particularly if they are already taking hormonal birth control. In small short-term studies, menstrual suppressants have been modestly more successful in alleviating period-related symptoms than traditional oral contraceptives.
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One of the difficulties, however, of drawing definitive conclusions about treatment is that PMS is a constellation of symptoms rather than a clear, distinct malady. You can’t test for it like a blood disease or cure it with antibiotics like an infection. That fact makes separating physical and social factors next to impossible, and it becomes hard to know which patients would benefit.

Another problem that distinguishes PMS is that prescribing hormones to treat it would necessarily be a long-term prescription. When the revelations of the Women’s Health Initiative made clear the irresponsibility of prescribing HT in the long-term, it was—and is—still possible to prescribe the drugs in the short term for the treatment of menopausal difficulties such as hot flashes and vaginal dryness. However, since we lack long-term safety data for menstrual suppressants, the wisdom of prescribing them for the treatment of PMS, even in extreme cases, remains an
open question. It is certainly not responsible to suggest the drug for PMS management in most women who are not otherwise seeking hormonal birth control.

What of other period problems? In particular, Coutinho is concerned with preventing two serious chronic problems, endometriosis and anemia.

Endometriosis happens when the tissue that lines the uterus grows outside the organ or on the ovaries, pelvic area, or bladder. Endometrial tissue, whether it grows where it’s supposed to or in a place it shouldn’t, responds to the hormonal messages the brain sends out. It builds up in response to hormones over the course of the month and breaks down. Unfortunately, when this breakdown doesn’t happen inside the uterus, blood and tissue have nowhere to go and become trapped in the body. This can cause scar tissue and cysts. It is frequently very painful and can lead to fertility problems.

Menstrual suppression drugs may be a good option for treating pain associated with this condition because they block the chemical messages from the brain that would cause errant cells to build up and bleed.

It is worth mentioning that this is different than claiming that continual menstruation
causes
endometriosis, as Coutinho and Segal argue. While it is true that continuous menstruation aggravates the condition, it is still a leap to claim that it is responsible for the rise in the incidence of the disease that doctors have observed in the past century. It may turn out that this is the case, but until we have more information, it is irresponsible to market menstrual suppression drugs preventatively.

Anemia is a disease in which the body doesn’t have enough red blood cells. Consequently, as blood flows through the body, it struggles to carry enough oxygen to the heart. It is treated and prevented by taking an iron supplement and also by making an effort to eat foods that are naturally rich in the mineral. For women who suffer from anemia, menstruation can cause further problems because the associated blood loss depletes iron stores.

In the United States, anemia is a tricky issue because while more women suffer from it than men, many women get too much iron. Period defender and author Dr. Susan Rako writes, “While we’ve heard a lot about ‘iron-deficiency anemia,’ and we know that we need enough iron in our diets to keep ourselves healthy, we know considerably less about the risks of excessive amounts of stored iron. Few of us have any idea how
iron-rich our diets may be.”
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Rako, author of
The Blessings of the Curse
, the only book to take on menstrual suppression, believes that menstruation provides a natural way for women to rid their bodies of excess nutrition that can potentially contribute to serious health problems such as heart disease.

Anemia is a more serious threat for women in developing nations, where, as Zahra Meghani points out, its major cause is “inadequate sanitation facilities, resulting in high incidence of hookworm disease.”
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She adds that “it is unclear how suppressing monthly menstruation is any part of a sound solution and quite clear how awesome a potential market the Third World can be for menstrual suppressant contraceptives.”
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The Advent of Menstrual Suppression Drugs

The wording of the FDA letter was harsh and unequivocal: Duramed Pharmaceuticals, at the time a division of Barr Laboratories, would have to make serious changes to their advertising campaign for the new drug Seasonale or face serious consequences.

Seasonale, the first pill to be specifically marketed for the purpose of menstrual suppression, was approved for use in the United States on September 5, 2003. The pill had been on the market for a little over a year when the letter went out in December 2004. It had gotten off to a slow start, but hopes for the drug were very high, with sales projections that warmed the hearts of company executives.

The FDA’s complaint was that Duramed was minimizing the risks of their new drug, specifically downplaying the significant intermenstrual bleeding and spotting patients experienced when taking this pill. It was, undeniably, a serious marketing problem. How did you convince patients to buy a drug for the prevention of bleeding that had the major side effect of causing … well … bleeding?

In the early 1980s international opinion suggested that women weren’t interested in eliminating periods, but this had started to change by the 1990s, perhaps due in part to books like
Is Menstruation Obsolete?
and the subsequent media coverage of its ideas. A multicountry survey published in 2003 found that there was “gradual acceptance of amenorrhea associated
with contraception.”
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Women were opening up to the idea of stopping their periods. Results from a questionnaire survey of countries in Asia, Africa, and Europe found that only black African women seemed to like their periods and that other women “would opt to bleed only once every three months, or not at all.”
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Study authors concluded that “providers tended to overestimate the importance of regular menstruation to their clients.”

This was all very good news for Duramed, who was in the process of winning an FDA green light for their birth control pill that would do just that—limit menstruation to every third month or a total of four periods a year.

An American study published in 2004 found that out of 1,470 women questioned, 59 percent expressed interest in either partial or complete suppression of menses. One-third would be willing to never bleed at all.
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Approval for the drug was based on a study population of 682 women who were randomized to Seasonale and a traditional oral contraceptive (Nordette) for one year. At the end of that time they found the drug’s efficacy and toleration to be similar to traditional birth control pills. There were indeed fewer periods but still a large number of bleeding and spotting days due to breakthrough bleeding. This problem decreased with usage, but was responsible for some patients discontinuing use before the year was over.
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In taking issue with Duramed’s marketing of the drug, the FDA pointed out that the pill’s labeling cautioned patients to weigh the desire not to bleed menstrually against the likelihood of bleeding intermenstrually and noted, “More Seasonale subjects, compared to subjects on the 28-day cycle regimen, discontinued prematurely for unacceptable bleeding.”
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How many women were having unplanned bleeding? According to the FDA, “During the first Seasonale treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting.”
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In other words, patients had a similar number of bleeding days as women taking traditional oral contraceptives. However, those on Seasonale didn’t know when those days would occur.

While bleeding decreased with time, the FDA pointed out that the use of the word “initially” when describing the breakthrough incidents was inaccurate, because even after a year of use, 42 percent of users were still reporting bleeding or spotting.

Finally, the FDA took issue with the advertisement’s suggestion that limiting periods had “no adverse effects” and that there was medical agreement on this fact. They pointed out that in reality the drug was associated with “numerous risks” and that “the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
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Four years later, it was Wyeth’s turn to debut their new drug Lybrel. While Seasonale cut bleeding to four weeks a year, Lybrel sought to eliminate it completely. This time, the study population included 2,134 women between the ages of eighteen and forty-nine with regular menstrual cycles. The trial lasted for nineteen months,
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during which time patients were asked to record in diaries whether or not they took the drug and any instances of bleeding that occurred. Only 921 of these women were still taking the pills a year later—that’s less than 50 percent of the original study population. Of the women who stopped taking the drug, 396 discontinued because of uterine bleeding.
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Other statistically significant side effects included increases in blood pressure and weight gain (although this was small, averaging less than two pounds).

After a year, 58.7 percent of women reported no bleeding or spotting, which means that 41.3 percent were still spotting after a year of use—that’s two out of every five subjects. And 79 percent of women reported no bleeding (blood flowing heavily enough to require sanitary protection), which means that 21 percent of women—one in five—were still experiencing bleeding that required menstrual protection. Bleeding and spotting did decrease with use: 93.9 percent experienced spotting with the first pill pack, while only 21 percent did by the thirteenth—but many women continued to experience problems. Again, far from offering women mastery over their menstrual cycles, the pills made bleeding even less predictable.

The FDA hesitated with approval in June 2006, citing, among other things, the need for additional analyses of their clinical data, especially data concerning pregnancy rates, bleeding patterns, and discontinuation rates among study participants (with such a large dropout rate, this shouldn’t have come as a surprise for Wyeth). Wyeth received an “approvable” letter, meaning that an eventual full FDA approval was likely, but not assured.
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The issues must have been resolved by May 2007, because the FDA
officially gave Wyeth the nod to start marketing. The approval letter cautioned, “Health care professionals and patients are advised that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting.”
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