Monday, May 21, 2007

Ladies’ Night

Boys may want to stop reading now. No, honestly, stop reading. Fine, don’t say you weren’t warned because tonight’s blog is about: periods. I knew that would get rid of the last of the male stragglers.

Seriously though, a world without ever having to have a period is a world I could deal with quite happily. I realize that there are people who say its unnatural and unhealthy, but they’re probably all men.

Read for yourself and see what you think. Are you going to join me in a tampon and pad burning ceremony? Or are you going to go the natural route and stick to being grumpy and bloated thirteen times a year? (Stupid lunar calendar!)
First birth control pill meant to end periods poised for approval
The Associated Press

TRENTON, New Jersey: U.S. women looking for a simple way to avoid their menstrual period could soon have access the first birth control pill designed to let women suppress monthly bleeding indefinitely.

The U.S. Food and Drug Administration is expect to announce approval Tuesday for Lybrel, a drug from Wyeth which would be the first pill to be taken continuously.

Lybrel, a name meant to evoke "liberty," would be the fourth new oral contraceptive that does not follow the standard schedule of 21 daily active pills, followed by seven sugar pills — a design meant to mimic a woman's monthly cycle. Among the others, Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonique, an updated version of Seasonale, reduces them to four times a year.

Gynecologists say they have been seeing a slow but steady increase in women asking how to limit and even stop monthly bleeding. Surveys have found up to half of women would prefer not to have any periods, most would prefer them less often and a majority of doctors have prescribed contraception to prevent periods.

"I think it's the beginning of it being very common," said Dr. Leslie Miller, a University of Washington-Seattle obstetrician-gynecologist who runs a Web site focused on suppressing periods. "Lybrel says, 'You don't need a period.'"

While that can be done easily — sometimes more cheaply — by skipping the sugar pills or replacing birth-control patches or vaginal rings sooner, doctors say the trend is fueled mainly by advertising for the new options. They expect plenty for Lybrel's July launch, although Madison, New Jersey-based Wyeth says it will market to doctors first.

Analysts have estimated Lybrel sales could reach $40 million (€30 million) this year and $235 million (€174 million) by 2010. U.S. sales of Seasonique, launched last August, hit $6.1 million (€4.5 million) in the first quarter of 2007. Predecessor Seasonale, which got cheaper generic competition in September, peaked at about $100 million (€74 million). Yaz, launched last August, had first-quarter sales of $35.6 million (€26.4 million); Loestrin 24, launched in April 2006, hit $34.4 million (€25.5 million) in the first quarter.

Still, some women raise concerns about whether blocking periods is safe or natural. Baltimore health psychologist Paula S. Derry wrote in an opinion piece in the British Medical Journal two weeks ago that "menstrual suppression itself is unnatural," and that there is not enough data to determine if it is safe long-term.

Sheldon J. Segal, a scientist at the nonprofit research group Population Council, wrote back that a British study found no harm in taking pills with much higher hormone levels than today's products for up to 10 years.

"Nothing has come up to indicate any unexpected side effects," said Segal, who co-authored the book "Is Menstruation Obsolete?"

Most doctors say there's no medical reason women need monthly bleeding and that it triggers health problems from anemia to epilepsy in many women. They note women have been tinkering with nature since the advent of birth control pills and now endure as many as 450 periods, compared with 50 or so in the days when women spent most of their fertile years pregnant or breast-feeding.

Barr Pharmaceuticals of Woodcliff Lake, New Jersey, whose subsidiary Duramed already is developing a lower-estrogen version of Seasonique, said its research with consumers and health care providers indicates they feel four periods a year is optimal, said spokeswoman Amy Niemann.

Wyeth obviously thinks otherwise.

"It allows women to put their menstrual cycle on hold" and reduces 17 related symptoms, from irritability to bloating, based on one small study, said Dr. Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals.

Marren said Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

That might cause too much breakthrough bleeding, already a problem with some newer pills with low hormone doses, said Dr. Lee Shulman, a Chicago obstetrician-gynecologist who chairs the board of the Association of Reproductive Health Professionals.

In testing of Lybrel, 59 percent of women ended up with no bleeding after six months, but 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.

"You're now basically trading scheduled bleeding for unscheduled bleeding, and I don't know whether American women will buy into that," Shulman said.

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