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U.S. likely to approve contraceptive designed to eliminate periods

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  • U.S. likely to approve contraceptive designed to eliminate periods

    NEW YORK: For many women, a birth control pill that eliminated monthly menstruation might seem a welcome milestone.

    But many also 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 to be made by the Food and Drug Administration next month has engendered controversy in the United States.

    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 worried about "the idea that you can turn your body on and off like a tap."

    That viewpoint is apparently one reason some birth control pills already sold, 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, Lybrel, is approved, Gal predicts an onslaught of advertising meant to persuade women to do just that. The drug's maker, Wyeth, said Wednesday that it was expecting agency approval in May but has declined to discuss its marketing plans.

    Lybrel is not yet available in other countries.

    Doctors say they know of no medical reason that women taking birth control pills need to have periods.

    The monthly bleeding that women experience while taking pills now on the market is not a real period, in fact. And studies have found no extra risks health risks associated with pills that stop menstruation, although some doctors caution that little research has been conducted on their long-term effects.

    The topic, however, has spawned an hour-long documentary by Giovanna Chesler, "Period: The End of Menstruation?"
    ( - PERIOD: THE END OF MENSTRUATION, The Film) now being screened on college campuses and among feminist groups.

    Chesler, who teaches documentary making at the University of California at 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 has also ignited a debate within the Society for Menstrual Cycle Research, a scientific organization that studies the medicine and social science of menses.

    In 2003, the group issued a position statement ( suppression) 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 coming meeting, scheduled for Vancouver in June.

    Hitchcock, the researcher and a director of the organization, said that although some research had 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," Hitchcock said.

    There has also been a backlash among groups that celebrate the period as a spiritual or natural process, like the Red Web Foundation. Red Web

    "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. Because the hormones in birth control 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 are usually 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 instable 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" only once every three months. Carol Cox, a spokesman for Barr, said Seasonale sales reached $120 million in the 12 months that ended in June 2006, before a generic equivalent by Watson entered the market. But even at that peak, Seasonale accounted for what Gal called a "small segment" of the $1.7 billion annual United States market for oral contraceptives.

    But Barr, which sees a larger market for the pills, is sponsoring a Web site Fewer Periods that explains how the pill works. 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 month. At a Wyeth presentation to investors and analysts in New York last October, the company's therapeutic director for women's health, 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.

    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, who coordinates the women's health program for nurse practitioners at MGH Institute of Health Professions in Boston. "We don't want to confront our bodily functions anymore," Andrist said. "We're too busy."

  • #2
    "We don't want to confront our bodily functions anymore," Andrist said. "We're too busy."
    negligence to her own body?- how arrogant is that? how far can we go- ostracise the natural process of our own bodily functions whereby we deem it acceptable to pop a pill in our mouth to get relief from 'limiting sexual activity and exercise, wearing dark clothes and staying home more'?

    It seems as if one fails to conceive
    The meaning my name strives to achieve

    To a biological form you cannot relate-
    Because a reproductive cell is a gamete not gamate!

    It means to unite, -to become consolidated
    So without me in, is there hope we'd be amalgamated?


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