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Alleges Anti-Woman Bias: TWU Suing to Gain Birth-Control Benefit

July 31, 2006

By GINGER ADAMS OTIS
Transport Workers’ Union Local 100 Recording Secretary Darlyne Lawson filed a sexual discrimination lawsuit against the Metropolitan Transportation Authority in Manhattan Supreme Court July 18 over the agency’s refusal to cover birth control pills in its company health plan.

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New Options Offer Better Periods

July 24, 2006

But now several new options are making their way onto the market, and they offer several added benefits… including far fewer periods!

Jill Pearson is a birth control user: “It’s wonderful, it’s … it makes me wanna tell everybody about my birth control pill.”

It’s a little unusual for a woman to praise her birth control. The reason Jill Pearson likes hers so much is that not only does it offer effective contraception, it dramatically reduces the number of her menstrual
periods. A big convenience and for Jill also a health benefit.

Pearson: “I used to get really bad migraines. I used to get really really bad pms
symptoms and so to not only have them less frequently but also they’ve also lessened in severity. that’s been a really really nice side effect.”

It’s part of what experts call a new era in birth control for women.

Dr. Carolyn Westhoff: “Same ingredients that are safe and proven but new recipes that come in several different flavors.”

Traditional birth control pills were 21 days of hormone and 7 days of placebo… which meant a kind of hormonal roller coaster.

Dr. Westhoff: “A lot of women don’t feel so well during that week off which is the same week that they’re going to have a period. With the new approach, the last 7 days of the pack has a little bit of hormone in it. That stabilizes the hormone levels for a woman and that gives her more manageable menstrual
periods.”

That’s exemplified by recently approved seasonique, which has a low dose of estrogen throughout the cycle and is also a new example of a trend begun in 2003 with seasonale … which instead of 3 weeks of active birth
control pills, has 3 months - so women get just 4 periods a year.

Another alternative is yaz: offering 24 days of active pills and four days of placebo for shorter, lighter periods.

And later this year lybrel is expected to win approval. It’s a continuous low dose option without any placebo interval.

Dr. Westhoff: “A woman could have as many or as few periods as she chooses, it’s
completely safe for her body. It’s completely safe for her uterus.”

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New birth control pill options are on the way

July 19, 2006

This is turning out to be a pivotal year in birth control.

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In the past six months, the Food and Drug Administration has approved an oral contraceptive that eliminates a monthly menstrual period, and can prevent mood swings and other side effects. It also has approved two others that feature shorter periods. And soon it’s expected to sign off on a yearlong oral contraceptive and a simpler version of a contraceptive implant.

Of course, there’s no long-term data on the new methods - and they aren’t for everyone - but doctors consider this new generation of birth control to be less risky and more sophisticated than the decades-old predecessors. And still in development are even safer, more-advanced options - with natural hormones and smoother delivery methods.

“Anytime there is a new method, there will be some women who say, ‘Oh, thank goodness, there is something for me,’” says Dr. Carolyn L. Westhoff, medical director of the family planning clinics at New York Presbyterian/Columbia University Medical Center in New York. “It’s not that different than trying to find the best pair of jeans to fit your body.”

That’s not an easy thing to do. But what seems to fit many women is curtailing or eliminating menstruation altogether.

Two brands of birth control pills, both approved this year and now available, feature shorter periods than the usual five to seven days. The products - Loestrin 24 Fe and Yaz - provide 24 days of active pills, forms of the hormones estrogen and progestin, followed by four days of placebo pills.

And in May, the FDA approved Seasonique, a slightly different version of Seasonale, which was approved in 2003 as the first continuous-use oral contraceptive. With Seasonale, which will become available in September, women take the active pills for 84 days followed by seven days of inactive pills to allow for a period. Seasonique, however, substitutes low-dose estrogen in place of the placebo pills so that a woman’s hormone levels don’t crash during the off week.

Finally, the FDA is considering an application to approve the first yearlong oral contraceptive. Lybrel contains only active pills without any break for a period. “For the last 40 years of the pill, one thing we’ve done is we’ve lowered the dose for improved safety,” Westhoff says. “But all along we were sticking to this original recipe of 21 days of hormones and seven days of placebo.”

The shift to continuous-use oral contraceptives acknowledges a little-known fact: Women don’t need to have periods.

Although early pills were associated with high levels of hormones and a related risk of blood clots, the level of hormones in birth control pills has dropped dramatically in the past two decades. Now, even taking an active pill 365 days a year is not thought to be harmful, says Dr. David Portman, director of the Columbus Center for Women’s Health Research in Columbus, Ohio.

Nor does the extended-use regimen appear to interfere with fertility. In a study of 187 women presented in May at a meeting of the American College of Obstetricians and Gynecologists, researchers reported that almost 99 percent of the women had a period or got pregnant within 90 days of stopping the medication.

“There is no lingering effect of the medication in the body because it is metabolized very quickly,” says Dr. Anne R. Davis, an assistant professor at Columbia University and lead investigator of the study. When oral contraceptives were introduced decades ago, the placebo week “was put in there to mimic the natural cycle,” she says. “It was done with the idea that the pill would be more acceptable to women. It wasn’t done because of safety or effectiveness.”

That’s not to say the pills are right for everyone. For those with a shaky memory, the downside of a year-round pill is remembering it every day. In addition, women who miss pills may have more trouble determining whether they are pregnant without a break from the pill for menstruation.

“You would have to go on other symptoms to know if you’re pregnant,” Davis says. Oral contraceptive use during early pregnancy is not thought to be linked to birth defects, she says.

However, the effects of taking Lybrel during several months of pregnancy have not been specifically studied. And some health experts caution that there is a lack of data on continuous-use birth control pill regimens.

Long-term protection
For women who find daily methods difficult, the first contraceptive implant to emerge since Norplant was removed from the market in 2002 is expected to be approved by the FDA this year.

That earlier implant consisted of six matchstick-size rods that were placed under the skin of the forearm to release fertility-controlling hormones. But the product had some problems, including difficulty inserting and removing the rods.

The new implant, Implanon, consists of a single rod that can prevent pregnancy for three years and is under FDA review.

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Cay Crow: New pills now allow women to totally suppress monthly cycles

July 17, 2006

For women on birth control, controlling their hormones means controlling their quality of life.

Modern birth control pills known as continuous oral contraception (COCs), such as Seasonale, limit a woman’s periods to four a year. Other products like Lybrel, (yet to be released in the U.S.) will limit or eliminate periods altogether by completely suppressing ovulation.

Women on hormonal contraception don’t really have periods but have withdrawal bleeding during the break from the pill. Most birth control pills follow the 21/7 model in which the woman takes small doses of hormones for three weeks and then takes placebo pills with no hormones for a week. During that no-hormones week, the woman has bleeding.

Doctors indicate that there is no known health risk in not having regular periods. In fact, for some women, reducing or eliminating periods can increase their overall health. Dr. Leslie Miller, an Associate Professor of Obstetrics and Gynecology at the University of Washington, says that the only reason for women to have regular periods is for reproductive purposes.

A century ago, women married much younger and had many children. As a result, women had on the average less than 50 periods during their reproductive years. Now that women are marrying later in life and having fewer children, the average woman can expect over 400 periods between the ages of 13 and 50. Dr. Miller and other researchers began to ask why this was necessary. Cyclical bleeding may contribute to increased yeast infections in women. The use of feminine hygiene products can lead to toxic shock syndrome and genital irritation, not to mention the inconvenience and cost.

Along with bleeding, other aspects affect a woman’s functioning cycle, as well. Better known as PMS, a woman’s mood, appetite, core body temperature, sensory detection and water retention all fluctuate with her menstrual cycle.

Benefits of birth control pills include lower risk of ovarian and endometrial cancer, osteoporosis, and pelvic inflammatory disease (PID). PID is the most common cause of infertility in women.

One especially promising benefit to the reduction or elimination of the menstrual cycle is the consistent maintenance of the endometrial lining. The endometrium is the blood and nutrient rich lining of the uterus that readies itself in preparation for a fertilized egg every month. It is the endometrium that sheds during a woman’s monthly period.

Possible negative effects of birth control pills include the increased risk of heart attack, stroke and blood clots. Women who are smokers over the age of 35 or who have unexplained vaginal bleeding or certain cancers should not use the pills.

The Association of Reproductive Health Professionals (www.arhp.org) conducted a random survey of 1,021 women between the ages of 18 and 40. None of the women had hysterectomies and none were trying to get pregnant. Forty percent of the women surveyed wish they could suppress their periods indefinitely. Women most interested in menstrual suppression include those with severe menstrual symptoms, low-income women and younger women.

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Now, a birth control bonanza

July 11, 2006

This is turning out to be a pivotal year in birth control.

In the last six months, the Food and Drug Administration has approved an oral contraceptive that eliminates a monthly menstrual period, and can prevent mood swings and other side effects. It also has approved two others that feature shorter periods. And soon it’s expected to sign off on a yearlong oral contraceptive and a simpler version of a contraceptive implant.

Of course, there’s no long-term data on the new methods — and they aren’t for everyone — but doctors consider this new generation of birth control to be less risky and more sophisticated than the decades-old predecessors. And still in development are even safer, more advanced options — with natural hormones and smoother delivery methods.

“Anytime there is a new method, there will be some women who say, ‘Oh, thank goodness, there is something for me,’ ” says Dr. Carolyn L. Westhoff, medical director of the family planning clinics at New York Presbyterian/Columbia University Medical Center in New York. “It’s not that different than trying to find the best pair of jeans to fit your body.”

That’s not an easy thing to do. But what seems to fit many women is curtailing or eliminating menstruation altogether.

Two brands of birth control pills, both approved earlier this year and now available, feature shorter periods than the usual five to seven days. The products — Loestrin 24 Fe and Yaz — provide 24 days of active pills, forms of the hormones estrogen and progestin, followed by four days of placebo pills.

And in May, the FDA approved Seasonique, a slightly different version of Seasonale, which was approved in 2003 as the first continuous-use oral contraceptive. With Seasonale, which will become available in September, women take the active pills for 84 days followed by seven days of inactive pills to allow for a period. Seasonique, however, substitutes low-dose estrogen in place of the placebo pills so that a woman’s hormone levels don’t crash during the off week.

Finally, the FDA is considering an application to approve the first year-long oral contraceptive. Lybrel contains only active pills without any break for a period. “For the last 40 years of the pill, one thing we’ve done is we’ve lowered the dose for improved safety,” Westhoff says. “But all along we were sticking to this original recipe of 21 days of hormones and seven days of placebo.”

The shift to continuous-use oral contraceptives acknowledges a little known fact: Women don’t need to have periods.

Although early pills were associated with high levels of hormones and a related risk of blood clots, the level of hormones in birth control pills has dropped dramatically in the last two decades. Now, even taking an active pill 365 days a year is not thought to be harmful, says Dr. David Portman, director of the Columbus Center for Women’s Health Research in Columbus, Ohio.

Nor does the extended-use regimen appear to interfere with fertility. In a study of 187 women presented in May at a meeting of the American College of Obstetricians and Gynecologists, researchers reported that almost 99% of the women had a period or became pregnant within 90 days of stopping the medication.

“There is no lingering effect of the medication in the body because it is metabolized very quickly,” says Dr. Anne R. Davis, an assistant professor at Columbia University and lead investigator of the study. When oral contraceptives were first introduced decades ago, the placebo week “was put in there to mimic the natural cycle,” she says. “It was done with the idea that the pill would be more acceptable to women. It wasn’t done because of safety or effectiveness.”

That’s not to say the pills are right for everyone. For those with a shaky memory, the downside of a year-round pill is remembering it every day. In addition, women who miss pills may have more trouble determining if they are pregnant without a break from the pill for menstruation.

“You would have to go on other symptoms to know if you’re pregnant,” Davis says. Oral contraceptive use during early pregnancy is not thought to be linked to birth defects, she says.

However, the effects of taking Lybrel during several months of pregnancy have not been specifically studied. And some health experts caution that there is a lack of data on continuous-use birth control pill regimens.

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Oral contraceptives give women more control

July 7, 2006

For the second time last week the FDA extended the review process for Lybrel, a new birth control pill manufactured by Wyeth Pharmaceuticals made to stop a woman’s period completely. Makers of the pill hoped for approval June 27, but were denied when the FDA decided to take another year to examine the pill’s effectiveness.

Oral contraceptives, first made popular in the 1960s, are now commonly used to prevent pregnancy. Pills are taken in a monthly cycle, with a week-long regimen of placebo pills that allow a woman to menstruate.

If approved, Lybrel will be the first oral contraceptive to be taken year-round without hormone breaks for menstrual periods. The pill is the next step in the recent move to make birth control convenient and timely for women who wish to control their menstrual cycle.

Michelle Famula, director of the women’s clinic at Cowell Student Health Center, said continuous hormonal contraception has been an area of interest in the medical field for years.

“The principle of continued hormone use to suppress menstrual bleeding has been used for a very long time,” she said. “It has been around for a long time, but has not been marketed for nearly as long.”

Famula also said she anticipates extended-cycle contraception will not harm those who choose to use it.

“It is safe, effective; it is for the most part harmless,” she said. “Birth control pills are not the only way to do this. There are other options as well.”

Oral contraceptive methods similar to Lybrel, such as FDA-approved Seasonale, allow four periods each year rather than 13. Although menstrual bleeding will subside with Seasonale, the risk of breakthrough bleeding and spotting increases, Famula said.

According to the makers of Seasonale, within the first year of taking the pill a woman is likely to experience the same number of bleeding days as with traditional birth control pills.

Famula said breakthrough bleeding is not something women should worry about.

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Period-suppression options examined

July 5, 2006

Encouraged by drug marketers, more women are opting to reduce the length or frequency of their menstrual periods, or skip them altogether — and even trading tips online for how to do it.

For decades, women have used birth control pills to occasionally skip a period, but only recently has the practice become the focus of marketing by drug companies and the subject of Web sites and blogs. Basically, the practice involves skipping the week of placebo pills that women using standard oral contraceptives typically take after three weeks of estrogen/progestin pills. (The placebos allow a menstrual period to occur.) Instead, counter to the label directions, they immediately start using a new month’s worth of the hormones. Skipping the recommended week off for the patch or vaginal ring achieves the same results.

Because the Food and Drug Administration hasn’t approved any continuous period-skipping method lasting longer than three months and the long-term safety of this tactic isn’t known, experts advise women to consult with their doctors before trying it.

“More patients are interested in the idea of using whatever hormonal contraception — whether it’s a vaginal ring or a patch or birth control pills — in a more or less continuous way,” said Philip Darney, a contraception expert who is chief of obstetrics and gynecology at San Francisco General Hospital. “In the past, we’ve talked to patients who might not have thought of it themselves. We’d suggest they simply continue taking the pills” if a woman had particularly painful or bothersome menstrual periods, or before a honeymoon or other important event, he said.

Today, doctors report that many patients are bringing up the idea of skipping or shortening their periods, often after hearing about the option through drug company ads. A few pills approved in recent years are designed to shorten the duration of or to reduce the frequency of menstrual periods; pills that stop periods on a more permanent basis are under development.

Pill pushers

In 2003, Seasonale, made by Barr Laboratories, became the first pill on the market designed specifically to reduce the frequency of women’s periods — in Seasonale’s case, to four times a year. A newer version approved in May, called Seasonique, maintains that cycle but replaces Seasonale’s placebo pills with low-dose estrogen pills thought to reduce the likelihood of irregular, or breakthrough, bleeding.

And a birth control pill being heavily advertised on television now, Loestrin 24 Fe, made by Warner Chilcott, claims to shorten the average period from more than five days to less than three.

The pills are not the first contraceptives used to alter the menstrual cycle — Depo Provera, a progestin-only injection introduced in 1992 and given every three months — was found to have the same effect for about half of its users. But the drug is associated with bothersome side effects including weight gain, headaches and thinning bones. Some women also modify their use of the birth control patch called Ortho Evra or the NuvaRing vaginal ring to skip their periods.

No period, no problem

It’s not surprising that women are interested in skipping their periods, said Alison Edelman, an assistant professor of obstetrics and gynecology at Oregon Health & Science University who has researched extended use of birth control.

“The seven-day period week that’s in (most) birth control pills wasn’t because of a scientific reason,” Edelman said. “It was put there because the makers of the pills were trying to mimic the menstrual cycle. They felt like women would want to have a regular period.”

But research shows that most women “say they want their period every three months, or less than that,” Edelman said.

Regina Levy, 25, of Burbank, Calif., is one of those women. She skipped her menstrual periods on and off for about six years.

“I had a vague notion in the back of my head that people did it occasionally with no detrimental effects,” wrote Levy in an e-mail interview. “When I first started taking the pill, I would skip this period or that period because it was inconvenient — (because of) a camping trip, Valentine’s Day or just general stress I didn’t want to deal with.” She has since gotten married and has stopped taking hormonal contraception.

And as methods for decreasing the frequency of menstrual periods have grown, online communities have sprung up that allow women to discuss when, how and why to practice what is variously termed “menstrual suppression,” “menstrual management” and “menstrual reduction.”

On the site, Kroi explains how to use specific types of birth control to skip periods and explains the difference between monophasic birth control pills — which contain the same amount of hormones every day, aside from the placebo week — and triphasic and biphasic pills, whose hormone content varies throughout the cycle. Monophasic pills seem to work best for continuous suppression of periods, say experts, but further study is needed.

Leslie Miller, an associate professor of obstetrics and gynecology at the University of Washington, runs the site www.noperiod.com, which addresses such concerns as “I don’t want to have my period during my honeymoon, help me!” and “What are the risks of suppressing my period?”

Contraceptive experts generally agree that “bleeding (during a menstrual period) is not a necessary part of contraception,” Miller said in an interview. But altering a woman’s cycle so that she menstruates only once every few months, for example, may introduce breakthrough bleeding, she said. Though studies have explored whether hormone levels can be adjusted to reduce or eliminate such bleeding, findings have been inconclusive.

What could be bad?

One issue many women encounter, doctors say, is getting insurance companies to pay for more pills, patches or vaginal rings than the labeling says is necessary. Some doctors said they’ve had success by writing a letter to the insurer on the patient’s behalf.

While extended use of contraceptive drugs spares women some personal hygiene worries and lets them avoid side effects such as bloating and cramping, there are also potential drawbacks. A key one is that a woman cannot be assured by having her monthly period that she is not pregnant.

Miller generally advises against teens’ using contraceptives to suppress their periods because studies are typically done on women age 18 and older. And because no long-term studies have proven the safety of these techniques, experts can only speculate on the risks of years of menstrual suppression.

“The longer-term question is: Does it increase the risk of cancers” such as breast cancer, or other known risks of birth control pills such as blood clots, Edelman said.

Levy said she initially worried that if she skipped her period, she could be pregnant and not know it. But she said that fear subsided.

“Since I always used more than one form of birth control, I would convince myself that I wasn’t pregnant the way I always did: that it wasn’t possible. Or at least so highly improbable as to be virtually impossible,” Levy e-mailed. “After about a week (the week I should have been bleeding), the feeling went away.”

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NUM declares dispute with Implats

July 3, 2006

The National Union of Mineworkers (NUM) over the weekend announced that it had declared a dispute over maternity leave and housing with South Africa’s second largest platinum miner Impala Platinum (Implats).

The declaration of the dispute followed a meeting between the two parties to address the implementation of existing agreements, NUM added.

Implats human resources executive Mike Teke said that the company wasn’t aware that the union had declared a dispute, as the company had received nothing in writing.

The company would issue a statement later on Monday, Teke added.

Implats management wanted to increase hostel fees, close kitchens and residential blocks so as to cut costs, NUM’s Implats representative Thabiso Poho said in a statement.

“This is indeed very strange given the boom in the platinum sector of the mining industry. That Implats does not want to convert the single sex hostels into family units in order to avoid these problems can only mean that they think these men are perfect in compounds where they are enclosed like animals,” NUM said.

“What is also of concern to workers is that the medical aid offered by the company does not enable them to include their spouses and dependants, and they cannot use it outside of the company because when they do so they have to bear the costs,” the union said.

“Another cause of the dispute is the fact that, while pregnant women do go on a four months paid maternity leave, their jobs are not secured upon their return and in most cases they lose them,” NUM alleged.

“This can only remind us of the dark days of apartheid when black women were subjected to birth control by racist white companies. For a big company such as Impala to be involved in such inhumane practices leaves a bad taste in our mouth,” the union alleged

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