FDA APPROVES FIRST PILL TO PREVENT PREGNANCY AND PERIODS

by: Sharifah Chammas

sahar@canyon-news.com

 A new birth control pill available this summer will give women the option to completely avoid a dreaded part of womanhood once considered unavoidable: the monthly female period.  The pill, called Lybrel, marks the first and only oral contraceptive designed to be taken 365 days a year and completely eliminates the menstrual cycle.   

In a decision sparking both controversy and excitement, the Food and Drug Administration approved the use of Lybrel as continuous contraceptive on May 22. 

The new pill: Lybrel, manufactured by Wyeth

"The whole idea of not having a period at all is extremely appealing to women," according to Camelia Davtyan, M.D., Associate Professor of Medicine at the University of California Los Angeles School and faculty member of the school's Women's Healthcare Center.

"A large segment of the female population would like to get rid of the idea of using tampons and pads," she said in a May 31 interview.  And according to Lybrel's manufacturer, Wyeth Pharmaceuticals, a woman taking Lybrel daily will no longer need these products.

"Where can I get it?!" exclaimed law school student Aliyah Sabreen when she learned about new pill.  Sabreen, 26, expressed a common sentiment found among women: "Women don't get days off from work or school for heavy or painful periods. I have to call in sick to work every month or miss class. My lifestyle and my livelihood are impacted every month and if I could eliminate the monthly burden, I would. My life would improve tremendously."

For women who suffer severe physical problems during their menstrual period, most doctors agree, Lybrel is a medically useful medication and beneficial to women.   Eliminating menstrual bleeding eliminates its concomitant painful side effects: excruciating cramps, migraines, heavy bleeding, bloating, nausea.  Periods inconvenience and detrimentally affect women in other ways by causing them to miss work days, interrupt plans or neglect responsibilities.  Of course, a consistent dose of hormones taken daily may also alleviate mood swings and PMS triggered by wildly fluctuating hormones.

Dr. Davtyan says the pill provides another option for "continuous contraceptive use," which doctors have practiced off-label for awhile to treat female patients suffering from endometriosis, migraines and other ailments associated with periods.

Doctors consider Lybrel, which contains a low dose of two synthetic hormones widely used in birth-control pills, no riskier than current pills on the market.

 Lybrel differs from current oral contraceptives on the market because it remains the first 28-day oral contraceptive created for women to take every day, without any break - 365 days a year - to completely halt all menstrual bleeding.

Traditional birth control pills adhere to the same pattern: 21 days of taking synthetic hormones followed by one week of placebo pills.  During the weeklong break from pills containing hormones, women experience an artificial period, medically known as "hormonal withdrawal bleeding," explains Dr. Davtyan.

"It is medically safe not to have a period when you are on the pill.  Because when you are on the pill you are not having a real period," she said.  She said the seven day break during which artificial bleeding occurs stems from male inventors' goal to initially design pills that "mimic reality as closely as possible."  While the period experienced on oral contraceptives looks like a period and feels like a real period, it's not a real period.  "It's a misconception a woman on the pill is really having a period," Dr. Davtyan says.

The National Women's Health Network estimates 12 million women take birth control pills, the most popular form of contraception for the past four decades.  However, today's pills are much safer and contain a lower dose of hormones.

The FDA said two yearlong clinical trials involving 2,400 women established that within the first year of taking Lybrel, the pill effectively and safely prevents pregnancy while suppressing menstruation.  However, 18 percent of subjects dropped out due to unscheduled bleeding or spotting- a problem common in low dose pills.

The FDA's decision to approve Lybrel ignited criticism on both medical and sociological grounds.

Some medical researchers question whether enough research was done and want more clinical studies on the long-term safety of Lybrel. 

Dr. Jean Elson, a medical sociologist, says the medication fuels gender bias and sends "young girls the message that menstruation is a problem rather that what it really is, which is a sign of health.  It's absolutely normal and natural for women and for girls of a certain age to menstruate."

She says our cultural history views men's body as the norm but "views women's bodies as a deviation from that and specifically menstruation as a deviation from a normal body."

Wyeth plans to make Lybrel available by prescription in July and package the pills similar to the traditional cyclic birth control pills, which include the days of the week and a round plastic dial.  Wyeth has not issued a price for the pills.   

-