April 24, 2007
For many women, a birth control pill that eliminates monthly menstruation might seem a welcome milestone.
But many 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.
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. Doctors say they know of no extra risk to the new regimen, but some women are uneasy about the idea.
“My concern is that the menstrual cycle is an outward sign of something that’s going on hormonally in the body,” said Christine Hitchcock, a researcher at the University of British Columbia. 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, a drug industry analyst at Sanford C. Bernstein.
But if the new pill, called Lybrel, is approved, Gal predicts an onslaught of advertising meant to persuade women to do just that. The drug’s maker, Wyeth, said
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last week that it was expecting FDA approval in May, but has declined to discuss its marketing plans.
The company’s research shows that nearly two-thirds of women it surveyed expressed an interest in giving up their periods. That dovetails with the findings of similar research conducted by Linda Andrist, a professor at MGH Institute of Health Professions in Boston.
“We don’t want to confront our bodily functions anymore,” Andrist said. “We’re too busy.” Doctors say they know of no medical reason women taking birth control pills need to have a period. The monthly bleeding that women on conventional pills experience is not a real period. Studies have found no extra health risks associated with pills that stop menstruation, although some doctors caution that little research has been conducted on their long-term effects.
Examining the debate
The topic has, however, spawned an hourlong documentary by Giovanna Chesler, “Period: The End of Menstruation?,” currently screening on college campuses and among feminist groups.
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.”
The subject also has ignited a debate within the Society for Menstrual Cycle Research, a scientific organization that studies 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. That statement could be revised at the group’s meeting scheduled for Vancouver, British Columbia, in June.
Long-term implications
Hitchcock, a director of the organization, said 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 Hitchcock, who is with the Centre for Menstrual Cycle and Ovulation Research.
There also has been a backlash among groups that celebrate the period as a spiritual or natural process, such as the San Francisco-based Red Web Foundation (www.redwebfoundation.org).
“The focus of our group is to create positive attitudes toward the menstrual cycle; suppressing it wouldn’t be positive,” said Anna Yang, a holistic nurse and executive director of the organization.
Eliminating menstruation is not a completely new concept. Women who take any kind of oral contraceptive do not have real periods.
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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.
But 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. The pills usually are packaged as regimens of 21 days of hormone pills and seven 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, drugmakers 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 drugmaker Barr caused a sensation in 2003 by introducing Seasonale, a contraceptive regimen packed as 84 hormone pills and 7 placebo pills. Users have “periods” only once every three months.
Carol Cox, a spokesman for Barr, said Seasonale sales reached $120 million in the 12 months ended June 2006, before a generic equivalent by Watson entered the market. Even at that peak, Seasonale accounted for what Gal called a “small segment” of the $1.7 billion annual U.S. market for oral contraceptives.
Barr, which says it believes there is a larger market for the pills, is sponsoring a Web site, www.fewerperiods.com, that explains how the pill works. 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.
At a Wyeth presentation to investors and analysts in New York in October, the company’s therapeutic director for women’s health, Dr. Ginger Constantine, presented data predicting that annual sales could reach $250 million for Lybrel, which is designed to be taken daily.
The company has not said what it expects to charge for Lybrel, but birth control pills generally cost $18 to $50 a month, depending on the brand.
Constantine cited company-financed research indicating that women often feel less effective at work and school during their periods. They limit sexual activity and exercise, wear dark clothes and stay home more, resulting in absenteeism, she said.
Menstrual suppression may be particularly appealing to women who suffer severe pain, heavy bleeding or emotional problems during their periods. A study by Canadian researchers found that women afflicted by heavy menstrual bleeding give up $1,692 a year in lost wages.
One woman who now uses Seasonale said she had found her periods debilitating before she started taking it.
“I had some months when I couldn’t get out of bed unless I popped 600 milligrams of Motrin,” said Marcella O’Neal, a department manager for Nordstrom in Atlanta. O’Neal, 36, said Seasonale had eliminated many of her symptoms - cramping, hot flashes and depression. “I love it, actually,” she said.
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.
Wyeth’s research indicates that ambivalence toward the menstrual period continues today. A close 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.
For some women who view their periods as the natural order of things, the qualms go beyond purely medical concerns.
At the alternative Bluestockings Bookstore on the Lower East Side of Manhattan this month, several dozen women gathered for the New York premiere of “Period: The End of Menstruation?”, Chesler’s hourlong documentary. Although it explores the idea of suppressing the menstrual period, the movie leaves the viewer to make up her own mind.
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