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Barr Raises Pliva Bid to $2.3 Bln, Beating Actavis

June 30, 2006

Barr Pharmaceuticals Inc. raised its offer for Pliva d.d. to $2.3 billion in cash to trump Actavis Group hf in the largest takeover of an eastern European drugmaker.

Pliva investors will get 755 kuna a share, or about $26.15 for each global depositary receipt, Woodcliff Lake, New Jersey- based Barr said in a PRNewswire statement today. Actavis offered 735 kuna a share yesterday, and said it already owns more than 20 percent of Zagreb, Croatia-based Pliva.

The acquisition would give Barr, the largest U.S. maker of birth control pills, access to Pliva’s European markets, where Barr currently has little presence. Actavis says it will fold much of Pliva’s European operations into its own. The winning bidder will become the third-biggest company in the world generic-drug market, which may reach $100 billion by 2010.

“Barr means more independence for Pliva, at least in the European markets,'’ said analyst Hrvoje Stojic at Hypo-Alpe-Adria Bank in Zagreb. “Actavis will want to take more control.'’

For that reason, Actavis may have a tough time persuading the Croatian government, which holds about 18 percent of Pliva through pension and privatization funds, to sell, Stojic said.

“I think they will continue to show their resistance,'’ he said. “They’re more for Barr.'’

Actavis Stake

Reykjavik-based Actavis used private purchases and call- option agreements to build up a stake in Pliva after the Croatian company’s management endorsed Barr’s bid June 27, Actavis Chief Executive Officer Robert Wessman said. U.S. takeover law prohibits Barr from making private purchases of Pliva stock.

Actavis spokesman Halldor Kristmannsson said company executives are examining Barr’s counterbid and will comment later today. Actavis touched off bidding for Pliva with a 570 kuna-per- share offer in March, later raising the offer to 630 kuna. Pliva’s management said the offer was too low, and opened up the bidding to other companies.

Pliva spokeswoman Marija Mandic couldn’t be reached for comment.

Barr is paying about 2 times Pliva’s revenue, compared with the 4.2 times that Sanofi-Aventis SA paid in March when it bought 24.9 percent of Czech generic-drug maker Zentiva NV.

Pliva was founded in 1921 and now has operations in more than 30 countries. About 1,400 of Pliva’s 6,000 employees are involved in sales and marketing, compared with 350 of Barr’s 2,000 workers.

Barr Markets

Barr gets about two-thirds of its sales from generic medicines, including the widely used blood thinner warfarin. The company sells the Plan B “morning-after'’ emergency contraceptive as well as the Seasonale birth-control pill that works by making women menstruate only four times a year.

Barr, with 50 generic drugs in development, will also gain the 120 that Pliva has in the works, and the capacity to expand into copies of genetically engineered medicines. The companies began cooperating last year on a copycat version of Amgen Inc.’s Neupogen, a white blood-cell stimulator used to treat cancer patients.

Actavis says it’s currently working on more than 300 products, and the addition of Pliva’s drugs would create “one of the strongest pipelines in the industry,'’ the company said in a statement yesterday. Actavis’s Wessman said he wants to create a company that will be able to take on the generic-drug industry leaders, Israel’s Teva Pharmaceutical Industries Ltd. and Switzerland’s Novartis AG.

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Barr to Buy Pliva for $2.2 Billion, Expand in Europe

June 28, 2006

June 27 (Bloomberg) — Barr Pharmaceuticals Inc. agreed to buy Pliva d.d., eastern Europe’s biggest drugmaker, for $2.2 billion, expanding outside the U.S. for the first time and doubling its sales.

Barr offered 705 kuna ($122) a share in cash for Zagreb, Croatia-based Pliva, 6 percent more than yesterday’s close, the companies said today in a statement. The offer topped a 630 kuna bid in April from Iceland’s Actavis Group hf.

The acquisition will give Barr, the largest U.S. maker of birth control pills, Pliva’s markets in Russia as well as the U.K., Germany, Spain and Italy, helping bring annual sales to $2.5 billion. Barr, with 50 generic drugs in development, will also gain the 120 that Pliva has in the works, including copies of genetically engineered medicines.

“Right now, Barr has practically no presence in central and eastern Europe,'’ said analyst Vladimira Urbankova at Erste Bank in Prague. For Pliva, “the drugs they have in the pipeline will be better marketed with Barr than without Barr.'’

Barr gets about two-thirds of its sales from generic medicines, including the widely used blood thinner warfarin. The Woodcliff Lakes, New Jersey-based company sells the Plan B “morning-after'’ emergency contraceptive as well as the Seasonale birth-control pill that works by making women menstruate only four times a year.

Analysts estimate the global market for generic medicines could reach $100 billion by 2010 as governments and insurers seek to slash costs.

Share Reaction

Shares of Barr fell 97 cents, or 2 percent, to $47.80 at 1:15 p.m. in New York Stock Exchange composite trading. Pliva’s global depositary receipts rose $1.47, or 6.5 percent, to $23.95 in London. Each GDR represents 20 percent of a Pliva share. The GDRs have gained 78 percent this year. They are worth about 686 kuna, compared with Pliva’s closing price of 665 kuna yesterday.

The merger will allow Barr to accelerate work on biogenerics, as copying biotechnology drugs is known, an area that may grow to $18 billion in four years, according to an estimate by Swiss drugmaker Novartis AG.

Barr and Pliva are developing versions of Amgen Inc.’s Neupogen, used to treat infections in cancer patients. Pliva is also developing a version of Amgen’s Epogen. The two products had combined sales of $3.7 billion last year.

Biogenerics

“In the long-term, biogenerics may be the number one asset,'’ Barr Chairman and Chief Executive Officer Bruce Downey said in a conference call today. “This consolidates in our companies all of the capabilities you need to develop, manufacture and sell these products.'’

Barr spent $133 million on research and development last year, compared with $73.6 million for Pliva. Barr will gain lower-cost manufacturing facilities at Pliva’s sites in Zagreb and in Krakow, Poland.

The transaction will leave Pliva’s management in charge of European operations, Pliva’s chief executive officer, Zeljko Covic, said at a press conference today. The Pliva brand will continue to be used in Europe, he said.

Pliva had a $75 million net loss in 2005 partly because the company abandoned its unprofitable proprietary drug-making operations. The company has struggled to recover from the expiration of the U.S. patent on its azithromycin antibiotic. The medication, which Pliva sells with Pfizer Inc. in the U.S., generated almost 25 percent of Pliva’s revenue for the first nine months of 2005.

Pliva’s competitors, such as Budapest-based Gedeon Richter Rt. and Prague-based Zentiva NV, have pretax profit margins on generic sales of about 20 percent, whereas Pliva’s is about 10 percent, she said.

Advisers

Barr was advised by Banc of America Securities. Pliva worked with Deutsche Bank. The offer depends on Barr getting at least 50 percent of Pliva’s shares, Covic said in a statement.

Barr is paying about 2.2 times Pliva’s revenue, compared with the 4.2 times that Sanofi-Aventis SA paid in March when it bought 24.9 percent of Czech generic-drug maker Zentiva NV.

Pliva was founded in 1921 and now has operations in more than 30 countries. About 1,400 of Pliva’s 6,000 employees are involved in sales and marketing, compared with 350 of Barr’s 2,000 workers.

The combined company will have 63 applications with the U.S. Food and Drug Administration seeking approval of generic drugs. Patents on drugs representing $103 billion in global annual sales will expire by 2010, according to London-based market researcher Datamonitor Plc

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It’s now easier for women to skip periods

June 26, 2006

Thanks to birth-control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn’t had a period since she was 17.

“It’s really one of the best things I’ve ever done,� she says.

A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring. After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

“I would never go back,� said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

“I have a ton of young girls in college who are doing this,� says Dr. Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. “There’s no reason you need a period.�

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth-control pill limits periods to four a year. The first continuous-use birth-control pill, Lybrel, likely will soon be on the U.S. market, and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don’t think suppressing menstruation is riskier than regular long-term birth-control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A non-scientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, “really bad cramps� and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about 1 in 5 women have used oral contraceptives to stop or skip their period.

“If you’re choosing contraception, then there’s not a lot of point to having periods,� says Dr. Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose Web site, www.noperiod.com, explains the option. She points out women on hormonal contraception don’t have real periods anyway, just withdrawal bleeding during the break from the hormone progestin.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today’s women may have about 450 periods.

Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.

The period is “way over-romanticized,� says Linda Gordon, a New York University professor specializing in women’s history and the history of sexuality.

“It doesn’t take long for women to go from being excited about having a period to feeling it’s a pain in the neck,� said Gordon, author of “The Moral Property of Women: A History of Birth Control Politics in America.�

She says caution is needed because there’s not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young – until research uncovered unexpected risks.

“People should proceed very cautiously,� she says.

Today’s birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Dr. Sheldon Segal, co-author of “Is Menstruation Obsolete?� Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition. Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women’s Health.

“They were then more comfortable recommending it to their patients,� said Wysocki, who uses a vaginal ring to prevent menstruation.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It’s a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62 percent last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all?

Users of Pfizer Inc.’s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two. There’s now a generic version, but the drug can thin bones.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But the extra prescriptions have led to insurance company hassles.

“What Seasonale did is get rid of that nuisance,� says Dr. Peter McGovern of University of Medicine and Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also in June, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade.

Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. Barr’s new product Seasonique, a successor to Seasonale, likely will get federal approval at week’s end.

Dr. Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this new trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy

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Taking aim at the issues

June 23, 2006

Now that Marc Holtzman’s bid for the Republican gubernatorial primary ballot has been given last rites by the Colorado Supreme Court, it’s time to look ahead to the November election battle between the GOP’s Bob Beauprez and Democrat Bill Ritter.

Here’s how the two candidates are contrasted on the issues - at least as of today:

• Issue: Marriage

Beauprez: Supports a constitutional amendment to define marriage as between one man and one woman.

Ritter: Opposes proposals to ban gay marriage; supports domestic partner benefits and same-sex unions.

• Issue: Immigration.

Beauprez: Wants to implement a quick, affordable system to allow employers to verify that people they hire are not in the U.S. illegally. Opposes spending state money to provide services to illegal immigrants beyond those required by the federal government. Supports the Defend Colorado Now initiative and Gov. Bill Owens’ call for a special session of the legislature to address it.

Ritter: Supports strengthening border security and more rigorous enforcement against employers who knowingly hire undocumented workers. Would deny welfare and driver’s licenses to illegal immigrants. Opposes the Defend Colorado Now initiative and the call of the legislature’s Democratic leadership for a special session to address immigration questions.

• Issue: Abortion

Beauprez: Opposes abortion except in instances when it is required to save the life of the mother. Opposes what some groups call partial-birth abortions, favors notification of at least one parent or guardian before a minor receives an abortion, and opposes taxpayer funding of abortions.

Ritter: Personally opposes abortion but supports the availability of birth control and emergency contraception. Would restore the family planning funding that has been cut as part of an overall objective to reduce the number of unintended pregnancies.

• Issue: Education

Beauprez: Supports the concept of vouchers in education; believes parents should have a choice of public, private, charter and home schools. Supports standards- based testing.

Ritter: Opposes vouchers; believes public education money should be spent improving public schools. Supports standards- based testing.

• Issue: Death penalty

Beauprez: Does not oppose the death penalty.

Ritter: Does not oppose the death penalty.

• Issue: Taxes

Beauprez: Supports Initiative 88, which would return excess Referendum C money to taxpayers. Opposed Referendum C.

Ritter: Opposes Initiative 88; supported Referendum C.

• Issue: Health care

Beauprez: Supports additional market-based reforms, including increases in health savings account use. Wants to prevent additional mandates on employers, such as requirements detailing the specific kind of coverage they must offer. Opposes any repeal of recent tort reforms.

Ritter: Supports establishing a plan to provide access to affordable health insurance for Coloradans who currently don’t have coverage.

• Issue: Amendment 38

Beauprez: Supports Amendment 38, which would make numerous changes to the petition process.

Ritter: Opposes Amendment 38.

• Issue: Renewable energy

Beauprez: Supports coal liquefaction, wind technology and agricultural alternatives, such as ethanol and biodiesel.

Ritter: Supports efforts to find cleaner ways to maximize use of fossil fuels as well as increased use of solar and wind technology and agricultural alternatives.

Troubled campaign

Marc Holtzman announced his campaign for governor Dec. 22, 2004, becoming the first candidate to enter the race. The beginning of the end of his campaign began this spring.

• March 6: Lobbyist Steve Durham files a complaint with the secretary of state, alleging that Holtzman last year worked hand in hand with an issues committee fighting Referendum C, then was aided by the committee in his own campaign for governor. Durham argued that Holtzman’s actions were illegal under Colorado law.

• April 20: Holtzman files paperwork with the state to petition his way onto the primary ballot.

• April 24: Holtzman’s campaign begins printing petitions.

• April 28: Holtzman decides to attend the Republican Party’s assembly May 20 in Colorado Springs.

• May 20: Congressman Bob Beauprez, who is challenging Holtzman for the GOP nomination, captures 72 percent of the vote among delegates at the state assembly. Holtzman receives 28 percent of the vote. Holtzman vows to petition his way onto the Aug. 8 ballot.

• May 22: Bob Martinez, the state’s Republican Party chairman, asks Holtzman to get out of the governor’s race, saying he fears a divisive primary could ruin the party’s chances in the general election. Holtzman refuses.

• May 23: Holtzman promises to keep campaigning even though 33 GOP lawmakers asked him to stop.

• May 25: Holtzman turns in more than 21,000 signatures to the secretary of state’s office.

• June 1: A Denver judge rules that Holtzman violated Colorado campaign finance law by illegally working hand in hand with a committee opposing Ref C last fall. Also, the secretary of state announces that Holtzman fell 743 signatures short of the number required to gain a spot on the primary ballot.

• June 2: Holtzman vows to fight his way onto the primary ballot, saying he has enough valid signatures to carry on his challenge to Beauprez for the party’s nomination for governor.

• June 6: Holtzman says he will bypass filing an appeal with the secretary of state and instead will ask a Denver District Court judge to allow him back in the primary.

• June 8: Holtzman’s attorneys file a lawsuit in Denver District Court with the aim of saving his campaign for the Republican nomination for governor.

• June 9: A Denver judge gives Holtzman a spot on the Aug. 8 Republican primary ballot, even though the courts have yet to determine if he has enough valid signatures to qualify for the primary. The ruling was in response to concerns that county clerks wouldn’t have enough time to get ballots printed if Holtzman’s name had to be added this summer.

• June 16: A judge rejects Holtzman’s argument that signatures should not have to come from individual congressional districts because provisional balloting allows voters to cast ballots in any county. The judge also gives Holtzman 48 hours to appeal his case to the Colorado Supreme Court or his name will be removed from the ballot.

• Tuesday: Holtzman takes his case to the state high court. He wants the court to issue an emergency ruling keeping his name on the primary ballot until his appeal is resolved.

• Thursday: The state Supreme Court refuses to consider Holtzman’s case. Holtzman drops out of the race and endorses Beauprez.

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Take control

June 20, 2006

Today’s women have more choices than ever when it comes contraception. With the introduction of new products to the market and high-profile advertising, selecting the most appropriate personal birth control option may be confusing.

Dr. Cynthia Wesley of Lotus Women’s Care and Dr. Louis Riley — both doctors of obstetrics and gynecology — spoke with The Daily News Journal about the most popular forms of contraception and who are the best candidates for use.

“I think it’s great for the average-day woman to have choices,” said Dr. Wesley from her office in the Physician’s Building at StoneCrest Medical Center. Her house slippers are stored neatly under her desk, and the young doctor explained she doesn’t even keep a white coat in her office. “With the help of your doctor, you can tailor your birth control. If you can’t be home at the same time every day to take a pill, that’s fine. If you’re a heavy bleeder and need help controlling that, you have choices. It’s very personal for each person.”

Finding a birth control that works for each woman “is almost like trial and error,” added Dr. Riley from his office, also located in StoneCrest’s Physician’s Building. “Women are just made differently. There’s still lots to be researched and understood about that.”

Both doctors agree the birth control pill is still a favorite among many patients. But, all pills are not created equal. Depending on the brand of oral contraceptive, types and levels of hormones can vary as well as the number of active pills packed for single monthly use. Risks include blood clots, strokes, heart attacks, high blood pressure and migraine headaches. Smokers older than 35 are discouraged from taking the pill due to an increased likelihood of cardiovascular side effects.

Both doctors emphasized that birth control pills do not protect users from contracting or spreading the HIV virus or other sexually transmitted diseases.

However, for preventing unwanted pregnancy, “the birth control pill works great,” Wesley said.

“There used to be only a handful of oral contraceptives out there,” Riley said. “Now we have a variety. We used to just have estrogen and progesterone with the same dose of both throughout the month. Now estrogen and progesterone vary week by week on the pill, and there are different types of progesterone.”

# Low-dose birth control pills are growing in popularity among many patients. A reduced amount of estrogen is what makes them low-dose, Wesley explained.

“Some women may get a little nauseous on the first two weeks of a regular pill,” Wesley said. “Some people may be less systematic on a low-dose pill.”

# Yasmin, a fairly new pill on the market, offers women an alternative combination of hormones.

“Yasmin has a different type of progesterone,” Wesley said. “It causes less bloating, but it is important to take it at the same time every day.”

The difference packaging makes:

# Seasonale is a traditional birth control pill that is packaged in three-month increments.

“It’s the same hormones; it’s just how they are delivered,” explained Riley. “You only have a placebo or hormone-free week every three months. That means you only have a period every three months. Doctors have done this for years for their patients, but it only just got FDA approval.”

In addition to all the risks associated with regular birth control pills, Wesley warned increased acne is also possible with Seasonale due to the product’s increased level of androgen.

“But some women just don’t care,” she said.

# Yaz and Loestrin 27 Fe are packaged with 24 active pills per box, three more than the average 21.

“The additional active therapy causes cycles to have shorter duration,” Wesley said.

“This is just people marketing the same product in a different way,” Riley said.

# The mini-pill is a progesterone-only pill and is safe to take while nursing.

“It is essential you take this pill at the same time every day,” warned Riley. “If you miss by two or three hours, you will start spotting.”

The patch resembles a large Band-Aid, and is applied directly to the skin. Users change the patch every week for three weeks, with one week free per month for menstruation.

“You don’t have to worry about taking the pill every day,” said Dr. Wesley. “But the FDA just announced (the patch) contained more Estrogen than other pills. I still prescribe it all the time. I don’t recommend it for overweight women because they don’t get the correct distribution of hormones.”

The shot contains only progesterone and is administered once every three months. The injections prevent the ovaries from releasing eggs and often completely stops the monthly cycle.

A significant risk of weight gain is associated with the method, as well as an increase in the risk of osteoporosis after three to five years, Wesley said.

“I usually recommend this for people who can’t remember to take a pill or who medically can’t be on estrogen,” explained Wesley.

The Nuevo Ring is a rubber ring that contains estrogen and progesterone. The device is inserted into the vagina and is worn in three-week increments.

“I love the nuevo ring,” said Wesley. “It releases the same amount of hormone on a daily basis so you maintain a steady state sooner. On the pill, you get a surge when you take it and then it goes back down.”

The doctors agree the ring can be left in place during intercourse and that most men can’t tell it’s in place. If the ring comes out, the doctors said to wash it and reinsert.

The IUD is a semi-permanent birth control option that is inserted in the uterus in the doctor’s office. The IUD is progesterone only and can last up to five years.

“It’s more recommended for women who have had vaginal deliveries because it makes it easier to insert,” Wesley said. “It’s not a requirement. It’s inserted in the doctor’s office, and although there’s a little cramping, you can go back to work that day. It’s very effective in preventing pregnancy. And if you decide in two years that you want to have children, you just come in and we take it out.”

While Wesley has prescribed several Mirena IUDs and is certain it is a safe option, Riley said he has yet to be convinced and will not perform the IUD method of birth control.

Barrier methods include condoms and diaphragms, of which Riley said the only major complication is pregnancy.

“Condoms don’t offer complete protection,” he warned. “You would have to wrap yourself in plastic wrap to do that.”

Sterilization permanently prevents women from getting pregnant. Women can choose from three tubal procedures: the post-partum tubal, the laproscopal tubal and the Essure.

The post-partum is done after the birth of the baby before the woman leaves the hospital. The laproscopal tubal ligation can be performed at any time and involves burning or clamping the fallopian tubes. The Essure is the newest method, and Wesley said doctors like to refer to it as the no-incision tubal.

“It’s done in the doctor’s office and we go through the vagina and plug the tubes,” Wesley explained. “As women find out about it, we do more and more of them because you can be in Wal-Mart that day if you want to.”

“Abstainingworks extremely well,” Riley noted. “And it prevents all those 40-plus diseases out there. Hormonal methods don’t prevent STDs, and condoms don’t even offer complete protection.”

“I think some people in society may still look negatively on the concept of birth control,” Wesley said. “But I think women’s health has come very far over the years, and it’s come far to make life easier. It’s not as taboo as it was years ago because you have more and more women choosing the professional route. They choose to pursue their professional careers first and have their babies later. There’s a lot to offer, and I think it’s fun.”

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Period-stopping pills spark controversy

June 14, 2006

Lena Sin, CanWest News Service; Vancouver Province
Published: Sunday, June 11, 2006
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VANCOUVER — The monthly curse may soon be optional for Canadian women.

Thanks to new forms of birth-control pills, women will have the option of saying goodbye to their periods.

A new oral contraceptive, Anya, the first continuous-use birth control pill designed to eliminate periods, is awaiting approval from Health Canada and may hit the Canadian market this year.

But already the end of the period is a divisive topic within the medical community.

While one camp sees it as new-found freedom for women, the other is calling it a hyped-up drug with unknown health risks.

The issue is expected to be a major topic when 1,000 experts gather at the Society of Obstetricians and Gynecologists of Canada (SOGC) meeting in Vancouver this month.

Menstrual suppression works by preventing thickening of the uterus lining.

This lining thickens each month in preparation for a possible pregnancy. When (after ovulation) a pregnancy has not occurred the uterus sheds that thick menstrual lining, hence the bleeding.

But if a woman ingests synthetic hormones at higher-than-normal levels, that prevents the lining from thickening, thus there’s nothing to empty.

Dr. Jerilynn Prior, scientific director of the Centre for Menstrual Cycle and Ovulation Research at the University of B.C., says she belongs to the minority who oppose continuous-use of the pill.

“It’s an artificial manipulation with high-dose estrogen and we don’t know the risks,” says Prior. “The menstrual cycle is carefully designed not just for reproduction but also for bones, breast, the brain and all of our physiology.”

A recent review of the literature on continuous-use birth control shows there’s a tendency for higher cholesteral, weight gain and a slightly greater risk of blood clots, she said.

Another study also showed lower bone density in women aged 24 to 45 who use the standard pill. Prior says this shows the health implications for the standard pill are not yet known, let alone the risks associated with continuous-use.

But Dr. Amanda Black, chair of the SOGC’s Contraception Awareness Project, doesn’t see menstrual suppression as any riskier than using the standard pill.

“Everybody always worries it’s not natural to not have a period every month,” says Black. “But basically they’ve done studies of the lining of the uterus and there’s no build-up of toxins people always think there’s a build-up of toxins.”

Studies have also shown there’s no adverse effects on the endometrin (uterus lining) and no increased risk of endometrial cancer, says Black.

Black emphasizes that menstrual suppression is nothing new.

Two recent national studies in the U.S. show about 1 in 5 women have used oral contraceptives to stop or skip their period.

And already, the Seasonale birth control pill is available in the U.S. and pending approval in Canada.

Seasonale is a standard birth-control pill taken for 12 weeks with a break for bleeding four times a year. Last year, Barr Pharmaceuticals recorded sales of $87 million US for the contraceptive.

“People forget that years and years ago women would have maybe 150 cycles in a lifetime because they’d be having babies and they’d be breast feeding for prolonged periods,” says Black. “Now women have on average of 450 cycles a lifetime.

“The argument becomes, is it really that natural to have a period every single month because we didn’t always do that.”

Vancouver Province

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Some women choosing to live period-free

June 11, 2006

TRENTON, N.J. - For young women with a world of choices, even that monthly curse, the menstrual period, is optional.

Thanks to birth control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn’t had a period since she was 17.

“It’s really one of the best things I’ve ever done,” she says.

A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring. After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

“I would never go back,” said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

“I have a ton of young girls in college who are doing this,” says Dr. Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. “There’s no reason you need a period.”

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don’t think suppressing menstruation is riskier than regular long-term birth control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A non-scientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, “really bad cramps” and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about one in five women have used oral contraceptives to stop or skip their period.

“If you’re choosing contraception, then there’s not a lot of point to having periods,” says Dr. Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose Web site, noperiod.com, explains the option.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today’s women may have about 450 periods.

The period is “way over-romanticized,” says Linda Gordon, a New York University professor specializing in women’s history and the history of sexuality.

“It doesn’t take long for women to go from being excited about having a period to feeling it’s a pain in the neck,” said Gordon, author of “The Moral Property of Women: A History of Birth Control Politics in America.”

She says caution is needed because there’s not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young - until research uncovered unexpected risks.

“People should proceed very cautiously,” she says.

Today’s birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Dr. Sheldon Segal, co-author of “Is Menstruation Obsolete?” Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition. Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women’s Health.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It’s a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62 percent last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all? Users of Pfizer Inc.’s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But extra prescriptions have led to insurance company hassles.

“What Seasonale did is get rid of that nuisance,” says Dr. Peter McGovern of University of Medicine/Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also this month, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade. Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. In May, an extended-cycle birth control pill that limits women to just four menstrual periods a year was approved by the Food and Drug Administration. Seasonique is made by Duramed Pharmaceuticals Inc., and is similar to the company’s Seasonale, approved by the FDA in 2003. Dr. Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy. “This redesign is way overdue,” she says. “It’s going to be the demise of 21-7.”

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With new mind-set, new contraceptives, menstruation becomes optional

June 7, 2006

With new mind-set, new contraceptives, menstruation becomes optional
By LINDA A. JOHNSON
Associated Press writer Tuesday, June 06, 2006

Stephanie Sardinha, 22, poses recently at the Southern New Hampshire University campus where she is a student in Brunswick, Maine. Thanks to birth control pills and other hormonal contraceptives, Sardinha hasn’t had a menstrual period since she was 17. Photo by Joel Page, AP.
TRENTON, N.J. — For young women with a world of choices, even that monthly curse, the menstrual period, is optional.

Thanks to birth control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn’t had a period since she was 17.

“It’s really one of the best things I’ve ever done,” she says.
A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring. After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

“I would never go back,” said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

“I have a ton of young girls in college who are doing this,” says Dr. Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. “There’s no reason you need a period.”

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don’t think suppressing menstruation is riskier than regular long-term birth control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A nonscientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, “really bad cramps” and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about 1 in 5 women have used oral contraceptives to stop or skip their period.

“If you’re choosing contraception, then there’s not a lot of point to having periods,” says Dr. Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose Web site, noperiod.com, explains the option. She points out women on hormonal contraception don’t have real periods anyway, just withdrawal bleeding during the break from the hormone progestin.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today’s women may have about 450 periods.

Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.

The period is “way over-romanticized,” says Linda Gordon, a New York University professor specializing in women’s history and the history of sexuality.

“It doesn’t take long for women to go from being excited about having a period to feeling it’s a pain in the neck,” said Gordon, author of “The Moral Property of Women: A History of Birth Control Politics in America.”

She says caution is needed because there’s not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young — until research uncovered unexpected risks.

“People should proceed very cautiously,” she says.

Today’s birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Dr. Sheldon Segal, co-author of “Is Menstruation Obsolete?” Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition. Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women’s Health.

“They were then more comfortable recommending it to their patients,” said Wysocki, who uses a vaginal ring to prevent menstruation.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It’s a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62 percent last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all?

Users of Pfizer Inc.’s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two. There’s now a generic version, but the drug can thin bones.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But the extra prescriptions have led to insurance company hassles.

“What Seasonale did is get rid of that nuisance,” says Dr. Peter McGovern of University of Medicine and Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also, this month the FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling in Europe for a decade.

Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. Barr’s new product Seasonique, a successor to Seasonale, likely will get federal approval at week’s end.

Dr. Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this new trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy.

“This redesign is way overdue,” she says. “It’s going to be the demise of 21-7

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Regulating Women’s Bodies

June 5, 2006

(Swans - June 5, 2006) It is hard to imagine a more confusing time to be female than in 21st century America. With the ever-increasing politicization of reproduction, the profit-motivated forces of the pharmaceutical and health care industries, and the media pressures to conform to standards of beauty and sexuality while opposing forces are increasing obesity and placing barriers on education, the fate of women today is falling into the hands of fundamentalist and out of those of the countless women who gave their lives in hard-fought battles for women’s rights, reproductive choice, equality in the workplace, and the recognition of the legitimacy of our intellect. A chilling image that personifies this movement is that of a smiling George W. Bush, surrounded by 9 smiling white male politicians and flanked by American flags, as the president signed the Partial Birth Abortion Ban Act of 2003. For their most recent grand idea, see Alma Hromic’s exposé of the Center’s for Disease Control campaign to define all females as walking wombs that must be prepared for potential pregnancy. Patriarchy is alive and well while the feminist movement continues its demise.

The competing forces of fundamentalism and profits crashed head on with the request by Barr Laboratories to make its approved prescription drug, Plan B, the so-called “morning after pill” for emergency contraception, available without a prescription. Plan B is not an abortifacient; it is taken within 72 hours of unprotected sex to prevent fertilization of an egg and, therefore, pregnancy. Though it was overwhelmingly recommended for approval as an over-the-counter drug by an independent advisory committee to the Food and Drug Administration (FDA), the FDA rejected its approval because of concern that young women, particularly those under 16, could use it safely without supervision. In fact, the acting director of the reviewing center at FDA, Steven Galson, stated that the rejection was his own decision (unilateral rulings are an uncommon practice), and he and other reviewers are on record expressing concerns about the drug’s impact on teen sexual behavior — the oversight and regulation of which does not, as of yet, fall under the FDA’s jurisdiction. In the meantime, the FDA has stalled a decision; Dr. Susan Wood, director of the FDA’s Office of Women’s Health and Dr. Frank Davidoff, a member of the FDA’s Nonprescription Drug Advisory Committee, resigned in protest; and the Center for Reproductive Rights’ filed a lawsuit, currently in trial, against the FDA.

In the meantime, contraception manufacturers are creating less controversial new markets by redefining menstrual periods as an avoidable evil — a 21st century illness, which can safely be eliminated by the use of their drugs. “Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.” It’s no wonder that market research reveals that women could live without their period… “Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.” Well, perhaps we don’t all welcome a period as a potential for pregnancy — perhaps we see it simply as normal biology.

Yet, there are increased risks associated with the “conveniences” of long-term birth control use — heart attack, stroke, blood clots, among others. Women were also told by the pharmaceutical industry that they didn’t have to suffer the hormonal inconveniences on the other end of the reproductive cycle, menopause. Estrogen replacement has been a billion-dollar market, with hormones to alleviate the symptoms of biological changes and medicate the transition, and the fringe benefits of protecting against osteoporosis and heart disease. Until a recent study, the Women’s Health Initiative trial, revealed an increased risk of heart disease, breast cancer, stroke, blood clots, and dementia with combination estrogen-progestin therapy. Do we simply choose our poison, or heed the warning not to mess with Mother Nature?

Women’s bodies have become defined as one evolving medical condition, with profitability at each step along the way. It would come as no surprise to see the re-emergence of Victorian-era hysteria as a common diagnosis of women’s myriad “maladies.” With a new anti-hysteria drug to follow, of course.

One rational fellow, UN Secretary-General Kofi Annan, sees reality quite clearly and objectively:

There is no tool for development more effective than the empowerment of women. No other policy is as likely to raise economic productivity, or to reduce infant and maternal mortality. No other policy is as sure to improve nutrition and promote health — including the prevention of HIV/AIDS. No other policy is as powerful in increasing the chances of education for the next generation. And I would also venture that no policy is more important in preventing conflict, or in achieving reconciliation after a conflict has ended.
While the U.S. puts more money toward fighting AIDS than any other country, it throws more than half of it to ineffective programs promoting abstinence, and shuns effective programs that promote condom use and prevent needle sharing. In other words, the funding of morality at the expense of the “sinners.”

Perhaps in the 21st century we’ll witness the end of Miss America pageants, the objectification of women as wombs, and the politicization of health, learning to embrace our hormones and not be controlled by the profits and testosterone of power. While women are now on a more equal education playing field and in some majors are surpassing men in terms of proportion earning degrees, we still fall 25% behind in pay. As our numbers grow in the legal and medical professions, perhaps the next generation will have the wherewithal to put their knowledge to power. Women activists would be better served directing their efforts — and money — to support girls’ education rather than throwing it toward causes we all are continuing to lose.

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Menstruation Becoming Optional For Many Women

June 3, 2006

For young women with a world of choices, even that monthly curse, the menstrual period, is optional.

Thanks to birth control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn’t had a period since she was 17.

“It’s really one of the best things I’ve ever done,” she says.

A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring. After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

“I would never go back,” said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

“I have a ton of young girls in college who are doing this,” says Dr. Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. “There’s no reason you need a period.”

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don’t think suppressing menstruation is riskier than regular long-term birth control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A nonscientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, “really bad cramps” and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about 1 in 5 women have used oral contraceptives to stop or skip their period.

“If you’re choosing contraception, then there’s not a lot of point to having periods,” says Dr. Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose Web site, noperiod.com, explains the option. She points out women on hormonal contraception don’t have real periods anyway, just withdrawal bleeding during the break from the hormone progestin.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today’s women may have about 450 periods.

Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.

The period is “way over-romanticized,” says Linda Gordon, a New York University professor specializing in women’s history and the history of sexuality.

“It doesn’t take long for women to go from being excited about having a period to feeling it’s a pain in the neck,” said Gordon, author of “The Moral Property of Women: A History of Birth Control Politics in America.”

She says caution is needed because there’s not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young — until research uncovered unexpected risks.

“People should proceed very cautiously,” she says.

Today’s birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Dr. Sheldon Segal, co-author of “Is Menstruation Obsolete?” Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition. Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women’s Health.

“They were then more comfortable recommending it to their patients,” said Wysocki, who uses a vaginal ring to prevent menstruation.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It’s a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62 percent last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all?

Users of Pfizer Inc.’s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two. There’s now a generic version, but the drug can thin bones.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But the extra prescriptions have led to insurance company hassles.

“What Seasonale did is get rid of that nuisance,” says Dr. Peter McGovern of University of Medicine and Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also in June, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade.

Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, is working on improvements to Seasonale and last November bought the maker of ParaGard, a copper IUD (intrauterine device) that blocks periods in some women.

Dr. Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this new trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy.

“This redesign is way overdue,” she says. “It’s going to be the demise of 21-7.”

On the Web

Dr. Leslie Miller’s site: www.noperiod.com

Association of Reproductive Health Professionals: www.arhp.org/healthcareproviders/resources/menstruationresour ces/patientinformation.cfm

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