Posted: 05/02/07

Contraceptive pill seeks FDA approval
New birth control completely eliminates meunstral cycle

Deanna Kaiser | contributing writer
dkaiser@smcvt.edu

Men and women alike may hear a little less of “it’s that time of the month,” if a new contraceptive pill, Lybrel, is approved by the U.S. Food and Drug Administration in May. A New York Times article, “The Pill That Eliminates the Period Gets Mixed Reviews,” reported that Wyeth Pharmaceutical is expecting FDA approval for their controversial pill that would completely eliminate a women’s menstrual cycles.

Lybrel proposed to put an end to periods

“The potential benefit of Lybrel would be that women with very painful menstrual and/or premenstrual symptoms might achieve total relief from those symptoms,” St. Michael’s nurse practitioner, Susan Jacques says.

Wyeth Pharmaceuticals have formulated Lybrel, a new type of birth control that is awaiting approval from the FDA. (Deanna Kaiser, photo)

Lybrel as described on the Wyeth Pharmaceuticals Web site, is a daily pill that provides a low dosage of ethinyl estradiol and levonorgestrel. When these two are taken together every day, they completely end the menstrual cycle.

Wyeth first presented Lybrel to the FDA in October of 2005. Wyeth released a statement in June 2006 saying that the drug had not been approved yet, but that Lybrel had received an “approvable letter,” from the FDA. This letter postponed the approval of the drug until questions surrounding manufacturing and data questioned are submitted and answered.

Similarly, like other oral contraceptives, there is an increased risk of blood clots for women while taking the pill, Jacques says.

In the statement, Wyeth representatives say they are certain the drug would receive approval.

“Wyeth is confident that we can address the questions raised by the FDA, and we expect to move toward the launch of Lybrel,” executive vice president and chief medical officer of Wyeth, Gary Stiles, M.D., said in the press release.

Although Stiles expressed his confidence that the FDA’s questions would be answered, critics of the pill say there could be emotional and mental side effects for women who take oral contraceptives that completely erase a menstrual cycle each month.

The upside and downside of the menstrual dilemma

Giovanna Chesler, assistant professor in the Department of Communication at the University of California San Diego and award winning filmmaker, voices her concerns for women ending their menstrual cycles in her film, “Period: The End of Menstruation?”

The film examines menstrual suppressant drugs, and includes commentary from both supporters and critics.

“Lybrel is the first birth control being advertised as a hormonal birth control that continually suppresses menstruation while you are taking it," Chesler says. "Menstrual suppressants have a few new drawbacks.”

Chesler says that menstrual suppressant Depo-Provera, a shot which suppresses a period for three months, had consequences that weren’t revealed in the short window of its testing. The Depo-Provera shot has been shown to weaken bone density over long periods of time, Chesler says.

She says that there is no known medical problem associated without menstruating while taking Lybrel or Seasonale.

Aside from the unforeseeable long-term effects of Lybrel, Chesler says that there are many mental and emotional consequences she fears for women who use menstrual suppression drugs.

“Menstruation is seen as a shameful function of our bodies and some women will be very quick to take nonstop hormonal pharmaceuticals to stop their periods,” she says.

The new birth control Lybrel, completely eliminates a woman's menstrual cycle. (Deanna Kaiser, photo)

“I wonder how young women who want to hide, control and contain their periods by taking these drugs make other decisions about their bodies,” she says.

Jacques says she feels that Lybrel, like other menstrual suppressants, is a safe option for women looking for birth control.

On Wyeth’s Web site the pharmaceutical company says the effectiveness of the pill is rated with the Pearl Index which represents the pregnancy rate among women who took Lybrel. Investigators for the trial said that Lybrel was similar to other oral contraceptives on the market and was 98 percent effective.

The downside of the pill, is that women who fall into the remaining 2 percent do not have the usual missed period indicating that they are pregnant.

“Some women like to have a menstrual period monthly to affirm femininity or to assure that they are not pregnant,” Jacques says. “Other women would be happy to never, or rarely, have a menstrual period again, especially women with very painful menses.”

Chesler also says that for women who have extreme cases of pain during menses, drugs such as Lybrel may be right for them, but wants to make women aware that there are natural remedies and relaxing methods that can ease pain.

Contraceptives and a catholic campus

Associate director of Edmundite campus ministry for pastoral services, Joanne Nelson, had one statement regarding the Church’s stance on birth control, and St. Michael’s reasons for not distributing it on campus.

“The Roman Catholic Church has been consistent in its teachings against artificial contraception,” Nelson says.

In 1968 the Roman Catholic Church released Pope Paul VI’s Humanae Vitae which reaffirmed the Church’s position that any form of artificial birth control is not condoned by the Catholic Church.

In a written response to the controversy surrounding condom distribution on campus in 1992, former St. Michael's President Paul J. Reiss outlined St. Michael’s beliefs.

Birth control distribution by on-campus health officials is prohibited at St. Michael's. (Deanna Kaiser, photo)

“It is not that sexual intercourse which is part of an enduring relationship of love and commitment, but rather casual sex that calls for a condom vending machine,” Reiss says in the article.

Sophomore George Smirnioudis says students should have access to birth control such as condoms on campus through a vending machine, or in the bookstore.

“I don’t think that just because we are at a Catholic college that we shouldn’t have access to condoms on campus,” he says.

That was the reasoning of the S.A. in 2004 when an initiative supporting distribution of condoms on campus was voted upon. The college, and President vanderHeyden, later denounced the idea. Although the college's response to the S.A. was clear, the subject of condoms on campus still sparks a heated debate.

Sophomore Alex Mouchatti says that the importance of having condoms on campus is for the protection of student’s health.

“Health services should give out condoms," he says. "It’s only promoting safety, not sex. Having sex is a choice, and giving out condoms isn’t saying go have sex in any respect."

Mouchatti says he questions what happens to the students who may not believe in the Catholic Church’s philosophy, or are having sex anyway.

“I think different forms of birth control are fine because if you do not want a child then you sholdn’t have one, it’s not fair to the child," he says. "Using birth control is being responsible."

Regardless of the Catholic Church’s reasoning, the bottom line is that condoms and other varieties of birth control like Lybrel, will not be condoned by the Church, or the college.

“Women deserve the choice and freedom of contraceptives,” Chesler says. “But, choice and freedom are very powerful words that necessitate knowledge, and my question is, do we have enough knowledge about suppressants and alternatives?”