ORTHOEVRA BIRTH CONTROL BLOG

Health News

July 31, 2006

Eleven-year-old Justina Erb sits with a stuffed animal on her knees, stroking its long, floppy, chocolate-brown ears. She has named her plush puppy Radical, a fitting moniker given the cuddly companion’s role in her life.

Radical is Justina’s “radiation buddy,” and he has been at her side through more than six weeks of treatments for a brain tumour diagnosed in April. But he is just one of many helpmates provided by the Hospital for Sick Children and Princess Margaret Hospital to ease the often long road of therapy for kids with cancer.

OTTAWA (CP) - The closest hospital to the tiny Arctic village where Mary Simon grew up was a long flight south to Montreal.

Now freshly elected as the top political voice for Canada’s Inuit, Simon gazed down at her left foot as she described what passed for health care when she was young.

TORONTO (CP) - Two months after Ontario finally decided to kick the habit, lobbyists who fought the province’s sweeping ban on smoking in public places say it’s having precisely the negative impact on their industries that they had feared.

In May, smoker’s rights group Mychoice.ca, which is funded in part by the tobacco industry, joined forces with pub owners, veterans, and charities in voicing concerns about the economic impact of the Smoke-Free Ontario Act.

PORT CANAVERAL, Fla. (AP) - Nearly 230 people aboard a cruise ship fell ill with a gastrointestinal illness during a weeklong Caribbean voyage, the company said.

The illness, believed to be a norovirus brought onto the Mariner of the Seas by a passenger, struck 221 of the ship’s 3,660 passengers and six of its 1,202 crew members, Royal Caribbean spokesman Michael Sheehan said Saturday.

(CP) - Hunter knows how to mellow out on marijuana. It’s something he does all the time. But the first time he smoked the leaves of a plant dubbed the “magic mint,” he felt as if he’d been slammed into another dimension.

As drug trips go, this one was more terror than pleasure.

BEIJING (AP) - China’s leaders on Saturday threw their support for the next director of the World Health Organization behind former Hong Kong health chief Margaret Chan, the country’s nominee for the post.

Chan, who was in Beijing for a four-day visit, met with Vice Premier Wu Yi, Vice Foreign Minister Dai Bingguo and Chen Xiaohong, a vice minister for health, the official Xinhua News Agency said.

BEIJING (AP) - A Chinese farmer who received a partial face transplant after he was badly disfigured in a bear attack has been discharged from the hospital and was regaining his health and self-confidence, state media said Saturday.

Li Guoxing, 30, who underwent surgery in Xijing Hospital in the central Chinese city of Xi’an, thanked the doctors and nurses after being released Friday, and said he was “very happy to go home,” according to the official Xinhua News Agency.

TORONTO (CP) - Canada has made the top 10 on a “world map of happiness,” which rates 178 countries ranging from Albania to Zimbabwe on their populations’ overall sense of well-being.

Ranked 10th in the world, Canada scored high on the map’s three major measures of happiness - health, wealth and access to education, said one of its creators, Adrian White of the University of Leicester in England.

VANCOUVER (CP) - A British-based think-tank has thrown its support behind the continued operation of a Vancouver safe-injection site for heroin users.

The Senlis Media Council said closing the Insite facility would be a major step backward for Canada and its drug policy.

CALGARY (CP) - An Alberta company was justified in continuing to sell a nutritional supplement to bipolar patients despite an order by Health Canada not to, a judge ruled Friday.

“The defendants were overwhelmingly compelled to disobey,” said provincial court Judge Gerald Meagher as he found TrueHope Nutritional Support not guilty of selling its product without a drug identification number.

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LONDON, Ont. (CP) - The makers of a contraceptive skin patch are facing a class-action lawsuit amid allegations the company failed to properly warn people of the health risks.

The law firm Siskinds LLP has launched the suit against Janssen-Ortho Inc. regarding its birth control skin patch Ortho Evra.

WINNIPEG (CP) - Drug maker Cangene Corp. (TSX:CNJ) has won a $143-million US contract from the U.S. government to supply an anti-anthrax drug that would be used to fight a bioterrorist attack.

The company announced Friday that the U.S. Department of Health and Human Services has exercised its option to buy 10,000 doses of anthrax immune globulin under changes to an earlier development and supply contract.

CHICAGO (AP) - The American Psychological Association is under fire from some of its members and other professionals for declaring that it is permissible for psychologists to assist in military interrogations.

An online petition against the group’s policy has garnered more than 1,300 signatures from members and other psychologists. Protest forums are being planned for the APA’s convention next month in New Orleans. And some members have threatened to withhold dues or quit.

(AP) - Tour De France champion Floyd Landis’ results on a urine test that spots elevated levels of performance-enhancing testosterone are a mystery and “don’t add up,” a leading doping expert said Thursday.

Landis’ team revealed Thursday that his urine sample last week showed “an unusual level of testosterone/epitestosterone.” Testosterone creams, pills and injections can build muscle and strength and improve recovery time after exertion when used over a period of several weeks, according to Dr. Gary Wadler, a member of the World Anti-Doping Agency and a spokesman for the American College of Sports Medicine.

WINNIPEG (CP) - People who want to grow pot for the federal government may soon get the chance.

Health Canada’s five-year, $5.75-million contract with its current supplier of medicinal marijuana, Prairie Plant Systems, appears to be winding down and the department is preparing to seek proposals from all potential suppliers.

RALEIGH, N.C. (AP) - In Arizona, they’re called the Non-Smoker Protection Committee. In Ohio, it’s simply Smoke Less Ohio.

Anti-smoking advocates? Hardly. Both are staunchly pro-tobacco and supported in part by North Carolina-based cigarette-maker Reynolds American Inc., which is working hard this year to defeat proposed smoking bans in those states, as well as ballot efforts to raise cigarette taxes in California and Missouri.

CALGARY (CP) - If donating blood is indeed the “gift of life,” then Canadians are a stingy lot.

As the Canadian Blood Service struggles through the traditionally slow summer period when most regular donors are on vacation, one fact remains - a very small percentage of Canadians are carrying the load for the entire country.

TORONTO (CP) - Hospitals across North America could be failing to diagnose small tumours in obese patients who either can’t fit into an X-ray scanner or have fatty tissue so dense the machine can’t penetrate it, a new study suggests.

The study, published in the August issue of the journal Radiology, found a growing number of patients are too large to fit into the scanner. In other cases, the X-rays have been fuzzy or imprecise because dense fat blocked the machine’s beams

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New Survey Reveals Birth Control Not Part of ‘Pill Lo’ Talk — Life Coach Lauren Howard Guides Women on Tough Topics –

July 28, 2006

RARITAN, N.J., July 26 /PRNewswire/ — Despite the significant impact contraception has on women’s health and well-being, a new survey finds that birth control and family planning rate last on the list of important topics that couples discuss. Ironically, marriage is twice as likely to zip lips on the subject of birth control and family planning, according to the survey commissioned by Ortho Women’s Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc.

The national survey, conducted by Harris Interactive(R), found that both married and unmarried couples find it difficult to discuss their relationships and feelings, even though these are the very topics they want to discuss more often. Instead, couples find a safe haven in talking about subjects like work or finances.

“Women are doing themselves a disservice by not talking about the topics that matter most to us,” says Lauren Howard, a licensed social worker and nationally recognized life coach. “When our conversations are filled with subjects that dilute what matters to us most, we are cheating ourselves of an opportunity to deepen and improve our relationships. The survey found that women who share frequent, meaningful conversations with their partners have significantly greater satisfaction in their relationships than those who don’t talk as frequently.”

To help women engage in more meaningful conversations, Ortho Women’s Health & Urology and Lauren Howard have partnered to launch an online educational program called “Pill Lo Talk” that empowers women to communicate about a variety of important topics. The program features a series of free, online guides available.

“No matter whom you’re talking with - your husband, your best friend or your doctor - conversations about important topics can be difficult,” says Ms. Howard. “Maybe we’re hesitant to rock the boat or we’re worried that things will turn confrontational. ‘Pill Lo Talk’ guides offer practical advice on how to initiate conversations on a variety of subjects and how to make them meaningful. The key is your ability to bridge the gap between everyday conversation and deeper talks.”

The survey covered 847 women and men ages 18-49 who are married or in relationships. Couples reported talking most frequently about work (86 percent) and finances (81 percent). They reported the greatest difficulty in discussing relationship expectations (52 percent) and feelings (51 percent).

According to responses, only 17 percent of married adults discuss birth control and family planning on a regular basis versus 46 percent of single adults. The survey also showed that 95 percent of couples who had meaningful conversations at least once a week reported greater satisfaction in their relationships, compared to 75 percent of those who had meaningful conversations less than once a week.

The “Pill Lo Talk” guides offer conversation starter topics and questions to explore individually or as a couple. They also include communication techniques such as creating the appropriate setting, active listening and non- verbal cues. A “How-To” section uses the topic of birth control to demonstrate how to prepare and initiate important discussions. Guides are customized for women in three different life stages: “Being Independent, Staying Connected” for those who are getting started in their adult life, “Living Healthy” for the health-conscious woman, and “Changes and Choices” for those experiencing a relationship milestone. A simple quiz will determine which guide is best for each life circumstance.

As a leader in the women’s health arena for more than 75 years, Ortho Women’s Health & Urology encourages women to not only talk to their healthcare professional, but to make those conversations count. The “Pill Lo Talk” guides will accompany other tools for women online at including the Patient-Doctor Communication Tool and the Birth Control Selector.

About Ortho Women’s Health & Urology

Ortho Women’s Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc., is celebrating 75 years of partnering with women. As a leader in the fields of women’s health and urology, Ortho Women’s Health & Urology is committed to helping people live healthier lives and to meeting the needs of providers and patients with products such as ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system), ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), DITROPAN XL(R) (oxybutynin chloride), and ELMIRON(R) (pentosan polysulfate sodium). For more information on these products, birth control, bladder health or general women’s health issues.

About ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol)

One of the low-dose hormonal contraceptive options for women is ORTHO TRI- CYCLEN LO, a triphasic birth control pill which offers high efficacy in preventing pregnancy with a low incidence of common side effects.

ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.

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Important Safety Information

ORTHO EVRA and ORTHO TRI-CYCLEN LO are hormonal contraceptives and are not for everybody. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use hormonal contraceptives are strongly advised not to smoke. Some women should not use hormonal contraceptives, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. Hormonal contraceptives do not protect against HIV or sexually transmitted diseases.

Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between ORTHO EVRA and a birth control pill containing 35 micrograms of estrogen.

Survey Methodology

Harris Interactive(R) fielded the study, sponsored by Ortho Women’s Health & Urology, from May 1-3, 2006, via its QuickQuery(SM) online omnibus service, interviewing a nationwide sample of 847 U.S. adults aged 18-49 years who indicated they are in a heterosexual relationship (married or unmarried). Data were weighted to be representative of the total U.S. adult population on the basis of region, age within gender, education, household income, race/ethnicity, and propensity to be online. In theory, with a probability sample of this size, one can say with 95 percent certainty that the results have a sampling error of plus or minus 5 percentage points of what they would be if the entire population of U.S. adults who are in a heterosexual relationship (married or unmarried) had been polled with complete accuracy. This is not a probability sample. A survey fact sheet is available at http://www.thepill.com/

About Harris Interactive(R)

Harris Interactive, the 13th largest and fastest-growing market research firm in the world, provides clients with research-driven insights and strategic advice to help them make more confident decisions, leading to measurable and enduring improvements in performance.

Widely known for The Harris Poll(R) and for pioneering online market research methods, Harris Interactive serves clients worldwide through its United States , Europe (http://www.harrisinteractive.com/europe), and Asia offices and is supported by its wholly owned subsidiary Novatris in Paris and an independent global network of affiliate market research companies. Harris Interactive is headquartered in Rochester, New York, and Europe operations are based in London.

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New contraceptive pokes interest of health care officials

July 24, 2006

Starting next year, birth control can be as easy as one doctor’s office visit every three years.

On Tuesday, the U.S. Food and Drug Administration approved Implanon, a 1 1/2 inch, single-rod contraceptive that is implanted into the interior of the upper arm of a woman. Implanon is a soft medical polymer that will only need a short office visit every three years to be continued, said Organon USA, the company that makes Implanon, on a Web site.

Implanon has been used by 2.5 million women in more than 30 countries since 1998 and will become more readily available to the United States in 2007.

Sarah Sayger, a doctor in the women’s clinic at Purdue University Student Health Center, said there are both positive and negative sides to the drug.

“It is implanted and stays for three years with no need for renewal,” Sayger said. “(However) contraception is not well covered by insurance, so students will have out-of-pocket expenses.”

She also said one of the negative sides is that anything that requires an office visit to implant will also require an office visit to remove, and that students may not like that.

“I think when we have more information available, we’ll assess whether it is appropriate for us to administer,” she said.

Implanon also has some of the same side effects as other hormonal contraceptives, such as headaches, nausea, acne, spotting and, rarely, blood clots.

In order to administer Implanon, health care providers will go through training, in which they will learn how to properly insert and remove the rod.

Although PUSH may decide not to administer Implanon in the future, it still will administer many other forms of birth control, some long-term and some short-term. They include

n NuvaRing, a vaginal ring that needs to be changed once a month. It is inserted into the body and releases hormones; it is more than 98 percent effective in protecting against pregnancy but does not protect against STDs.

n Ortho Evra, a patch that needs to be changed once a week. The patch is placed anywhere on the skin and is approximately 99 percent effective against pregnancy but also does not protect against STDs.

n A variety of birth control pills that must be taken once daily. The one-cycle contraceptives contain 21 hormonal pills and seven placebo pills to complete a full menstrual cycle. The other type of oral contraceptive, the extended-cycle contraceptive, contains one pill a day for three months.

n Nonhormonal contraceptive methods include condoms (both male and female), diaphragms, cervical caps and spermicide. Male and female condoms can be purchased in any drug store and require no prescription. Diaphragms and cervical caps must be used with spermicide and require a prescription.

Valorie Wade, the administrative director of St. Thomas Aquinas Center, said the Catholic Church does not believe in contraceptives and highly promotes abstinence.

“We believe all life is sacred,” she said. “It’s a very complex issue. The number one thing is (the Church doesn’t) like the inhibition of the sperm and egg meeting.”

Wade also said that even though the Church does not condone the use of contraceptives, God will forgive a woman who has committed a wrong in the Church’s eye

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Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Estate of 26-Year-Old Woman Who Died After Using Ortho Evra for 7-1/2 Months — JNJ

July 19, 2006

Parker & Waichman, LLP announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of the estate of a 26-year-old woman. The decedent died from an acute pulmonary embolism after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was filed in the United States District Court for the Eastern District of Michigan.

On July 8, 2003, the decedent experienced difficulty breathing and collapsed in her home. Paramedics arrived and found the woman in acute respiratory distress. She was taken to the emergency room at St. John Macomb Hospital in Michigan, where emergency room doctors noted she was cyanotic (blue lips and skin) and in severe respiratory distress. The decedent did not respond to CPR and other life-saving measures and was pronounced dead that evening. An autopsy revealed the cause of death as an acute pulmonary embolism.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen.

The drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products.

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J&J Buys Ensure Medical

July 17, 2006

Cordis, the heart and vascular device unit of Johnson & Johnson, said Thursday it acquired privately held wound-closure startup Ensure Medical.

Although J&J didn’t release financial details about the buyout, the company said it expects to take an estimated one-time charge of approximately $52 million, or $0.02 per share, as a result of the acquisition.

The news coincided with the unrelated announcement of a lawsuit against J&J in relation to concerns over its Ortho Evra birth control patch.

Ensure was bought for its experimental device for closing femoral artery incisions following catheterization, the process of inserting a hollow tube into the body.

Catheters are often inserted into a vein or artery and guided through the heart chambers and surrounding vessels for purposes of examination or treatment. Other uses include draining body fluids, such as urine, and introducing fluids into the body.

Unique to Ensure’s technology is that it uses a synthetic bioabsorbable material to stop bleeding and close the site of the arterial puncture. This differs from conventional methods that use manual compression to close the access wound site. J&J hopes that bioabsorbable material will in part contribute to a faster closure time and reduce bed-stay.
Other Perks

But that’s not the only possible perk of a bioabsorbable wound closure. “We have seen evidence to indicate that patients may experience less pain and can return to self-sufficiency much sooner,� said Peter Fitzgerald, a founder of Ensure who is a professor of medicine at Stanford
University Hospital.

Ensure, base in Sunnyvale, California, was formed in 2002. The startup received $10 million total in three rounds of funding, according to Morgenthaler Ventures, which contributed to the financing. Venture firms that also weighed in on the deal included The Vertical Group, U.S. Venture Partners, Delphi Ventures, Saratoga Ventures, Venrock Associates, and Latterell Venture Partners.

Nearly 8 million patients undergo cardiac catheterization procedures annually. But it will be a while before J&J can tap that market with Ensure’s technology as clinical trials are expected to start in early 2007.

But either way, the move adds another technology to J&J’s Cordis portfolio of cardiac and vascular devices, said Rick Anderson, J&J’s company group chairman, and Cordis Franchise’s worldwide chairman.

J&J’s Cordis is most famed for its drug-eluting stent, a little medicated tube that props open a blocked heart vessel after it’s been cleared.

In April 2003, the company first introduced it to the United States and triggered a revolutionary heart disease treatment that today has spurred a market worth more than $5.5 billion worldwide (see Surviving as a Stent Startup).

The acquisition of Ensure could play into the space as doctors use a catheter to clear an artery and place the device.

Birth Control Suit

The news did not help J&J’s stock, which fell $0.14 to $60.48. The decline stemmed in part from broader geopolitical concerns, but also from the announcement of a lawsuit against the company related to its birth control patch Ortho Evra.

In November of last year, the U.S. Food and Drug Administration warned that the Ortho Evra birth control patch exposes women to higher amounts of estrogen than some other contraceptive methods (see Drugs & Devices: Flu Chutes).

In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of that.

Regardless, the Parker & Waichman law firm said Thursday it filed suit against Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson. The firm is suing on behalf of the estate of a 26-year-old woman.

The decedent died from a blood clot after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was fil

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Doctors check on fetuses online

July 11, 2006

The heartbeats of unborn children at Park Ridge Hospital will now be only a mouse-click away.

The hospital has installed a $350,000 fetal monitoring system that allows doctors and nurses to monitor unborn babies’ heartbeats and moms’ contractions in real time on a computer software system that can be accessed outside the patient room and over the Internet.

Staff stationed at the Family Birth Place at Park Ridge can now watch the vital signs of all their patients in labor from computer stations in the unit — instead of having to go into each individual room to read the monitors. Doctors can also access the fetal heartbeats and contractions of their patients from remote locations such as their homes if they can’t immediately be at the bedside. The Internet access is only for those who are caring for the patient.

Strong Memorial and Highland hospitals already have similar systems, and Rochester General is currently looking into purchasing one.

“It enables us to more quickly and accurately document what we’re doing,” said Dr. Albert Jones, chair of obstetrics and gynecology at Unity Health System, which runs Park Ridge.

Previously, record of the fetal heartbeat was printed out in fever-chart form on rolls of paper and kept with a patient’s records. But the images often fade within 10 years, said Cheryl Fletcher, perinatal nurse educator at Park Ridge. Now, the fetal heartbeat and contraction records are archived electronically along with a patient’s medical records.

Also, Fletcher said, computer monitoring in the birthing center allows more eyes to watch for anything that could be going wrong with any of the patients. Fletcher said the unit has 15 birthing rooms.

The effort corresponds with work at Park Ridge and other area hospitals to one day be free from paper records. Unity is already donating $100,000 toward the Rochester Regional Health Information Organization, a continuing Rochester communitywide effort to make all medical records electronic.

“It’s a privilege to see some of the things that have developed,” said Burton S. August, who along with his brother, Charles J. August, and their families donated much of the money used to purchase the new Park Ridge fetal monitoring system. The Augusts, founders of Monro Muffler Brake, have donated undisclosed millions to Unity Health System, including money that made the Family Birth Place possible in 1998.

Tina Zwetsch, 30, of Rochester, experienced the new fetal monitoring system when she had a healthy baby girl, Madelynn, at Park Ridge Sunday. Incredibly, Zwetsch said she didn’t know she was pregnant; she said she hadn’t gained that much weight and was on birth control. But the fetal heartbeat she saw on the computer screen next to her bed convinced her the pregnancy was for real.

“I was looking on the screen and thought, ‘Oh my God, I guess that’s it,’” Zwetsch said.

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Period-suppression options examined

July 7, 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.”

Women OB/GYNs weigh in

One site — a blog called “The Well-Timed Period” (http://thewelltimedperiod. blogspot.com) — is written by Diana Kroi, a New York OB/GYN and the author of a book called “Take Control of Your Period” (Berkley Trade 2004, $12).

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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Should teenagers have access to birth control?

July 5, 2006

“I believe that teens should have access to birth control. I know some people are going to argue with this statement, saying that if teens have access to birth control without their parents’ knowledge, it will lead to more teens having sex and getting pregnant. This argument doesn’t hold up for me. Teens have sex, and will continue to have sex, with or without any protection. Withholding birth control is not the way to go about decreasing the amount of teen sex. Allowing teens access to birth control helps to prevent pregnancies and STDs from being transmitted.

The real problem that needs to be addressed here is the fact that so many teens are having sex at all. The scare tactics used frequently in schools and with conservative religious groups don’t seem to be working very well anymore, so maybe it’s time to try something new. However, keeping birth control and information away from teenagers is not the way to go about it.”

Trish Marx, junior,

Oakland High School

“Sex education is different for everyone. Some people believe it is best not to talk about that issue, while others feel it needs to be discussed in order to inform the teen. One issue that is on the forefront of this debate is whether teens should be able to have access to birth control.

Many high school students already have classes, such as senior health, that deal with abstinence and other issues, but the education stops there and does not go further to provide teens with safe birth control.

It is best for teens to have access for birth control because the students have a choice to make: follow what the classes have told them or go on their own and participate in sexual acts.

If the students do have sex, then with accessible birth control they will have protection and most likely won’t be vulnerable to any diseases, whereas teens that do not have access to birth control can put themselves at risk.”

Drew Carson, senior,

Roseburg High School

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Kansas City Based Law Firm, Peterson & Associates, P.C., Files Suit against a Division of Johnson & Johnson on Behalf of a 46-Year-Old Woman Who Suffered a Stroke after Using Ortho Evra Birth Control Patch — JNJ

July 3, 2006

Kansas City based law firm, Peterson & Associates, P.C., announced that is has filed suit against Ortho McNeil Pharmaceutical, Inc., a division of Johnson & Johnson (NYSE:JNJ), on behalf of a 46-year-old woman and her husband. The woman suffered a stroke while using the Ortho Evra(r) Birth Control Patch for only three months. The suit was filed in The Superior Court of New Jersey near Johnson and Johnson’s world headquarters. For more information on Ortho Evra(r), please visit

To the best of its knowledge, Peterson & Associates, P.C. is the first Kansas City based law firm to file suit in a New Jersey Court relating to the side affects of the Ortho Evra(r) Birth Control Patch.

In October 2004, the injured woman began experiencing severe headaches and was taken to a nearby emergency room. Soon after, she was diagnosed as having suffered from a stroke on the left side of her brain. Because of the stroke, she suffers from permanent memory loss.

The Ortho Evra(r) Patch is an adhesive, transdermal birth control patch that is worn on a woman’s arm, abdomen, torso or buttocks. It is intended to administer 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. The patch is worn for one week and then replaced. No patch is worn in the fourth week during menstruation. Over 4 million women have used the Ortho Evra(r) Birth Control Patch.

On November 10, 2005, Ortho McNeil and the FDA issued a warning about the increased risks of blood clots associated with using the Ortho Evra(r) Patch. In the new warning, Ortho McNeil admitted that women who use the Ortho Evra(r) Patch are exposed to up to 60% more estrogen than women who use the birth control pill. The FDA announcement can be found atl. In 2001, when Ortho Evra(r) was first put on the market, Ortho McNeil represented that women on the patch are exposed to the same amount of estrogen as those who take the birth control pill.

Strokes, which damage nerve cells in the brain, are often caused by interrupted blood flow from a blood clot. Depending upon the area of the brain that is damaged, strokes can cause coma, paralysis, speech problems, dementia and death.

In addition to causing strokes, Ortho McNeil warns that the Ortho Evra(r) Birth Control patch may cause heart attacks, pulmonary emboli and deep vein thrombosis (DVT), all of which may ultimately result in death.

It is alleged that Ortho McNeil and its parent company Johnson and Johnson were aware of the increased medical risks associated with Ortho Evra(r) before the drug was approved by the FDA. It is also alleged that even after the drug was approved, both companies failed to adequately warn patients about the risks. Evidence allegedly shows that the risk of developing blood clots and injuries caused by them (such as strokes) is significantly higher using the Ortho Evra(r) Patch versus the birth control pill.

The FDA logged 9,116 reports of adverse reactions to Ortho Evra(r) in the seventeen month period from April 2002 through September 2003. By way of comparison, the leading oral contraceptive, Ortho Tri-Cyclen(r) (which has six times as many users as Ortho Evra(r)), only generated 1,237 adverse event reports to the FDA during the six year period from November 1997 through September 2003.

About Peterson & Associates, P.C.

Peterson & Associates, P.C. is a leading products liability and personal injury law firm that has collected over $300 million in settlements and judgments for its clients. Headquartered in Kansas City, Missouri on the Country Club Plaza, Peterson & Associates, P.C., represents clients nationwide. Under the guidance of the firm’s president, David M. Peterson, Peterson & Associates, P.C. has collected compensation for thousands of clients who have suffered injuries from using dangerous medications. The Firm is currently representing individuals injured by Vioxx(r) Bextra(r) Celebrex(r) Zyprexa(r) ACE Inhibitors, Fen-Phen and exposure to Benzene. For more information on Peterson & Associates, P.C

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