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BY OUR PHARMA CORRESPONDENT 20
April,2007:
The United States Food and Drug Administration
is likely to give nod to a pill that could
eliminate the need for women to have monthly
menstruation.
The new pill, called Lybrel, is approved may come
as a welcome milestone for many women.
Particularly to those who suffer severe pain,
heavy bleeding or emotional problems during their
periods.
According to the research done by Wyeth –the maker
of the drug-- nearly two-thirds of women it
surveyed expressed an interest in giving up their
periods. 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
effect.
Suppression of 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.
However, the new contraceptive pill could create
controversy debate among others who view their
periods as fundamental symbols of fertility and
health.
Traditionally, views about menstruation have been
different. While some cultures shunned women who
are menstruating, others believed that
menstruating women had special powers.
Many researchers have found rather than loathing
their periods, women evidently carry on complex
love-hate relationships with them. “My concern is
that the menstrual cycle is an outward sign of
something that’s going on hormonally in the body,”
remarked C L. Hitchcock, a researcher at the
University of British Columbia.
Also, they go on arguing that women are not sick
and they don’t need to control their periods for
30 or 40 years.
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.
Of late, several new drug have been launched in
the market that tinker with menstrual cycle and to
shorten span of bleeding.
Barr, for instance, launched Seasonale in 2003, a
contraceptive regimen packed as 84 hormone pills
and 7 placebo pills. Seasonale sales reached $120
million in the 12 months ended June 2006, before a
generic equivalent by Watson entered the market.
But even at that peak, Seasonale accounted for a
“small segment” of the $1.7 billion annual United
States market for oral contraceptives.
Barr is sponsoring a Web site,
www.fewerperiods.com , that explains how the
pill works. Expecting a larger market for the
pills. The company also plans a direct advertising
campaign within the next few months for a newer
version, Seasonique, which also reduces periods to
four a year.
And Wyeth at a presentation predicted that annual
sales could reach $250 million for Lybrel, which
is designed to be taken daily. However, 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.
BY OUR PHARMA CORRESPONDENT |
