ORTHOEVRA BIRTH CONTROL BLOG

Male Birth Control Pill

November 30, 2006

LOS ANGELES — Birth control pills may not be just for women any longer. British researchers are working on a male birth control pill.

The female birth control pill was introduced in the 1960s, 100 million women now take it worldwide.

But what about men popping the pill?

Scientists in London said they’ve found a solution: A hormone free pill that stops the release of sperm, without interfering with pleasure.

“It’s not stopping sperm production. It’s not a hormonal method. It’s just simply stopping the muscle which takes the sperm along,” said Dr. Christopher Smith with King’s College.

NBC4’s Dr. Bruce Hensel said this means the man could have sex but could not make a woman pregnant

A single dose would be taken a few hours before having sex.

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Then still have the same performance and sensation, but the sperm would stay put making it much more user friendly than other methods already on the market.

“One of the problems with the hormonal pill, which is quite good, is that men have to inject themselves or have implants or patches and that it’s what men don’t like,” said Dr. Nnaemeka Amobi.

With this pill, there’s no need to worry. Within half a day, sperm release would return to normal

“Some women are absolutely tired of having to take responsibility for contraception all the time and would be delighted to give that over to their partner,” said Rebecca Findlay with Family Planning Association in London.

If this reaches the market, which may take a few years, it would still be important to practice safe sex because the pill does not protect against sexually transmitted diseases

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PHILIPPINES: MUSLIM REBELS ENDORSE BIRTH CONTROL PLAN

November 28, 2006

Cotobato City, 28 Nov. (AKI) - In an effort to slow down demographic growth, the Philippines’ largest Muslim rebels group has urged all Filipino Muslims to observe Manila’s birth control programme. Eid Kabalu, spokesperson for the 11,900-strong Moro Islamic liberation Front (MILF), told AdnKronos International (AKI) that the Assembly of Darul-Iftah, an organization of Islamic religious authorities or imams, has issued guidelines on the birth control programme of Filipino president Gloria Macapagal-Arroyo.

“There’s nothing wrong with the family planning programme. It was reviewed by the Darul-Iftah and they are also endorsing it,” Kabalu said.

“We are advising our fellow Muslims to coordinate with government health workers. We encourage Muslim couples to practice it because it will help in all aspects of human life,” he added.

The country is 85 percent Catholic. The Catholic Church only allows natural family planning methods.

Manila’s health department family planning programme is based on responsible parenthood, which gives married couples the responsibility of not having one child after another, as regional health officer Abdullah Dumama, explained to AKI.

“The government is not banning having children. But what the government is proposing under birth spacing is to lower the birth rate based on the natural cycle of women,” he said.

According to Dumama, a sound population control programme would inform citizens and help them practice birth spacing that would result in fewer births.

However, Kabalu stressed that a family planning programme for the Muslim community should be anchored on the principles of “non-coercion, responsible parenthood and informed choice.”

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“It does not refer to abortion, neither to birth control but birth or child spacing and should be the couple’s decision,” he said, quoting what the late MILF chairman, Salamat Hashim, once had told him.

To strengthen his point, he reminded that in 2004, 22 Muslim religious leaders signed a fatwa – religious edict - affirming that “improved reproductive health conditions benefits individual Muslims and strengthens the Muslim nation socially, economically, politically and in all other aspects of human life.”

At the same time, Kabalu added, “the fatwa stated that all methods of contraception are allowed as long as they are safe, legal, in accordance with the Islamic Shariah and approved by a credible physician preferably a Muslim for the benefit of both the mother and the child.”

In general, Muslims believe that birth control and prevention of pregnancy are prohibited except when the pregnancy places the mother in danger or cause illness which will affect her life.

Based on the 2000 census, the country’s population was growing at the rate of 2.36 percent each year, or 1.6 million babies.

In mid-2006, the population was estimated at over 87 million. By 2025, the number of Filipinos is estimated to reach 115.7 million if the current trends persists and, given the five-year-old census baseline, the population could hit 100 million in the next five to six years.

The population of the southern Filipino island of Mindanao is growing fast at 2.42 percent per year, higher than the national average of 2.36 percent.

In the Autonomous Region in Muslim Mindanao (ARMM), the 2.4 million populace is growing by 3.86 percent with most families having an average household size of 6.13, the highest nationwide. ARMM is also the poorest part of the country.

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The Family Un-Planner

November 22, 2006

On Monday, the federal office that oversees the nation’s family-planning program got a new boss who doesn’t believe in birth control. Eric Keroack is a Massachusetts obstetrician-gynecologist who argues that abstinence until marriage is the only healthy choice for women. Until recently, he served as medical director of a pregnancy-counseling organization that runs down contraception and gives out scientifically false health information—for instance, that condoms “offer virtually no protection” against herpes or HPV. Keroack also promotes a wacky piece of pseudoscience: the claim that premarital sex disrupts brain chemistry so as to create a physiological barrier to happy marriage.

Keroack’s appointment, as deputy assistant secretary of population affairs within the Department of Health and Human Services, did not require congressional approval. The Bush administration picked him on its own. And women’s health advocates, editorial pages, and bloggers, along with Democratic members of Congress, are right to think he’s a crazy choice for this job.

The Title X family-planning program, which Keroack will now oversee, has a federal mandate to provide information and access to birth control, as well as pregnancy tests and counseling. (Patients may receive referrals for abortion, but Title X funds may not be used to pay for the procedure.) The program also offers information and treatment for sexually transmitted diseases and screening for breast and cervical cancer. Title X has been financially squeezed in recent years, but it still funds approximately 4,500 clinics that serve about 5 million patients across the country.

Keroack’s professional history suggests a mismatch, to put it mildly, with Title X’s goal of educating women about contraception and helping them get it. He has lectured widely for groups like the National Abstinence Clearinghouse, which disparages the use of birth control and disseminates medical misinformation. The policy statement of the pregnancy-counseling organization he served as medical director for, A Woman’s Concern, says:

A Woman’s Concern does not distribute, or encourage the use of, contraceptive drugs and devices. … A Woman’s Concern is persuaded that the crass commercialization and distribution of birth control is demeaning to women, degrading of human sexuality, and adverse to human health and happiness.

The statement further claims that widespread availability of birth control, especially for young people, “actually increases (rather than decreases) out-of-wedlock pregnancy and abortion”—a view that flies in the face of persuasive evidence (see here, here, and here).

Misleading or factually false information about sexual health abounds in the group’s educational materials and on its Web site. To disparage the notion of “safe sex” and make the case that abstinence is the only healthy choice, A Woman’s Concern teaches that condoms “only protect against HIV/AIDS 85% of the time, which means you have a 15% chance of contracting it while using a condom.” And, lest a patient consider having an abortion, it claims that teens who undergo the procedure “may face an eight times greater risk of contracting breast cancer by age 45.”

These claims have been resoundingly discredited. Recent studies show that condom use can substantially reduce the transmission of HPV, herpes, and numerous other STDs. Condoms also dramatically reduce the risk of HIV infection. The research on condoms and HIV transmission that Keroack’s group seems to allude to is a report by the National Institutes of Health that found “an 85 percent decrease in risk of HIV transmission” for condom users compared with nonusers (my italics). The twisted version of this statistic touted by A Woman’s Concern implies that if 100 kids have sex while using condoms, 15 will become infected with HIV—an absurd suggestion.

As for the purported link between abortion and breast cancer, that old favorite of the pro-life movement was refuted by research published in the New England Journal of Medicine in 1997. After pro-lifers snuck an ambiguous statement on the topic onto a government Web site in 2002, a scientific panel appointed by the director of the National Cancer Institute knocked it down in 2003. That panel examined all of the available population-based, clinical, and animal data and found no link between induced abortion and breast cancer. Nor is there a plausible, biological mechanism that would connect abortion to breast cancer. As medical director, Keroack should have known better than to promote this information. That he didn’t suggests a willingness to manipulate science to interfere with patients’ ability to make informed choices—a willingness to breach the ethics of his profession.

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In Keroack’s own lectures and writing, he also makes claims designed to scare the bejesus out of kids to convince them to remain abstinent. One pet theory involves the neuropeptide oxytocin, which plays a role in mother-child bonding and social affiliation. Keroack claims that that people who engage in premarital sex experience chronic emotional pain, which lowers their oxytocin levels. This in turn impairs their ability to form healthy relationships down the road. “People who have misused their sexual faculty and become bonded to multiple persons will diminish the power of oxytocin to maintain a permanent bond with an individual,” he writes.

Keroack’s cites research on oxytocin levels in animals like prairie voles. There are obvious problems in extrapolating from voles to humans, whose brains are much more complex. A handful of human studies show a role for oxytocin in promoting sociability. But there are inconsistencies. One study found that lactating women who had higher plasma levels of oxytocin reported being more sociable. But two others found that women with higher oxytocin levels reported higher relationship distress—precisely the opposite of Keroack’s claim. More crucially, there are no data to suggest a causal link between oxytocin levels and marital happiness—or between any of this and premarital sex. Keroack’s claim is simply “not borne out by the current evidence,” says Jennifer Bartz of Mount Sinai School of Medicine, author of an excellent review article. To be less polite, this is a guy who takes a neuropeptide and a prairie vole and spins from them science fiction.

In his new role, Keroack will have extensive power to shape the kinds of information disseminated to millions of women. He will be able to develop new guidelines for clinics, set priorities, and determine how scarce dollars get spent, says Marilyn Keefe of the National Family Planning and Reproductive Health Association. “We’ve seen that people in these political slots have a tremendous influence over how programs get implemented,” she said. A spokeswoman for the Department of Health and Human Services defended the appointment in an e-mail, stating that “Dr. Keroack is highly qualified and a well-respected physician.”

But at a moment when the need for subsidized birth control is rising, and clinics are struggling to pay for basic services—not to mention advances in screening and prevention like the HPV vaccine—a new hire hostile to family planning and accurate medical information is the last thing women need. Keroack has also won props from the Christian right for using ultrasounds in pregnancy counseling. He argues that the images dissuade women from having abortions and that at A Woman’s Concern, the number of patients choosing abortions dropped dramatically when the ultrasounds were introduced. So, stay tuned. This innovation, too, may be coming to a publicly funded clinic near you.

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Studies Show Essure Procedure is Permanent Birth Control Option for Women Not Suitable for Tubal Ligation Surgery

November 21, 2006

Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure(R) procedure, the first and only FDA-approved, non-incisional permanent birth control method available, announced today that new independent study data released at the 35th Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) shows the Essure system eliminates risks associated with traditional surgical sterilization for many women not eligible for permanent birth control.

Unlike surgical tubal ligation, which involves cutting, clipping or burning a woman’s fallopian tubes, the Essure procedure does not require any incisions and can be done in a physician’s office under local anesthesia. Tiny, lightweight Essure coils are passed through the cervix and inserted into the fallopian tubes, forming a permanent blockage. Women typically return to normal activity within a day after the Essure procedure, rather than a week or more following tubal ligation surgery.

“Considering the risks associated with tubal ligation, including potential trocar injuries, infections at the incision site and complications associated with general anesthesia, we encourage physicians to educate patients about the benefits of the Essure procedure,” said Mark Sieczkarek, president and chief executive officer of Conceptus. “The studies presented at this year’s AAGL - each of which is a first-of-its-kind undertaking - are further proof of the safety and efficacy of the Essure procedure for all patients, particularly those where a tubal ligation is either contraindicated or where the surgical risks are high.”

One study, Historical Risk Factors, Are They a Contraindication For Office Essure?, presented at AAGL by Mark Levie, M.D., and Scott Chudnoff, M.D., of Albert Einstein College of Medicine at Montefiore Medical Center in New York, showed successful placement of the Essure device among women with historical risk factors that could affect tubal cannulation. More than 92 percent of women in this study successfully had the Essure device placed.

“Women with histories of pelvic inflammatory disease, sexually transmitted disease, termination of pregnancy and cesarean section can still have highly effective placement of the Essure device in an in-office setting,” said Dr. Chudnoff. “These women do not need to undergo the risks of a laparoscopic sterilization procedure under general anesthesia in an operating room simply due to prior risk factors.”

A second study, The Impact of Obesity on Office-Placement of Essure, also conducted by Drs. Levie and Chudnoff, suggests the Essure procedure can be performed on obese women in an office setting with excellent success rates. In this study of women with an average body mass index (BMI) of 36.2, nearly all had a positive experience with the procedure. In the obese group, successful placement of the device was achieved in 74 of 81 (91 percent) obese women, compared with 101 of 110 (92 percent) women in the non-obese group.

“Obese patients are better candidates for the Essure procedure than for a laparoscopic tubal ligation under general anesthesia,” commented Dr. Chudnoff. “There are simply fewer potential complications for these women with an office-based procedure that does not require general anesthesia.”

“The studies present positive news for women in search of permanent birth control who may not be candidates for laparoscopic tubal ligation due to the associated risks,” said Dr. Levie. “With the Essure procedure, risks are minimized. In my experience, this also has contributed to high patient satisfaction.”

A third study, The Essure Micro-Insert System for Hysteroscopic Sterilization in Women with Cardiac Disease: 19 Cases, by Drs. S.A. El-Nashar, M.R. Hopkins, D.J. Driscoll and A.O. Famuyide of the Mayo Clinic in New York, documented 19 women with heart disease, all of whom had successful placement of the Essure device with no intra-procedural complications. The women in this study had cardiac disease, including adult congenital heart disease (ACHD) and valvular or ischemic heart disease (V/HD); factors that would place them in a “high-risk” category for both pregnancy and surgical tubal ligation.

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Additional findings from a Dutch study presented at the meeting by Michel Vleugels, M.D., entitled Management of Patients for Essure Sterilization in the Outpatient Department Without Any Anesthesia at All, demonstrates the Essure procedure can be performed successfully with no need for anesthesia. Of the 273 women documented in the study, the placement success rate was 94.1 percent with a very low overall pain score (2.7 on a scale of 0-8).

About the Essure(R) Procedure

The Essure procedure, approved by the FDA in 2002, deploys a soft micro-insert into the Fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. A woman is able to return home about 45 minutes after the procedure is completed. There is a three-month waiting period after the procedure during which women must use another form of birth control. The Essure procedure is 99.80% effective (based on four years of follow-up data). The Essure procedure has been demonstrated in a small portion of the women undergoing clinical studies to be 99.74% effective (based on 5 years of follow-up). Five-year follow-up of all patients in clinical trials is ongoing.

About Conceptus

Conceptus, Inc. manufactures and markets the Essure Permanent Birth Control system, an innovative medical device and procedure designed to provide a non-incisional alternative to tubal ligation, which is currently the leading form of birth control worldwide. The availability of the Essure procedure in the U.S. is expected to open up a market currently occupied by incisional tubal ligation and vasectomy, which combined account for more than 1 million procedures annually.

Additional information about the Essure procedure is available at www.essure.com or by calling the Essure Information Center at 1-877-ESSURE1. Additional information about Conceptus is available at www.conceptus.com or by calling 1-877-ESSURE2.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Discussions regarding performance of Essure in the office setting, lower risk associated with Essure and other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors such as strategic planning decisions by management, re-allocation of internal resources, decisions by insurance companies, scientific advances by third parties, and introduction of competitive products, as well as those factors set forth in the Company’s most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, and other filings with the Securities and Exchange Commission.

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Burg Simpson Files Suit on Behalf of a Colorado Woman Who Suffered a Pulmonary Embolism and Deep Vein Thrombosis Caused by the Ortho Evra Birth Control Patch

November 20, 2006

DENVER, Nov. 16 /PRNewswire/ — Burg Simpson Eldredge Hersh & Jardine, P.C., announced today that it has filed a lawsuit against Johnson & Johnson, the makers of the Ortho Evra birth control patch, on behalf of a Colorado woman who suffered a pulmonary embolism and deep vein thrombosis due to her use of the Ortho Evra birth control patch.

At the age of 31, the plaintiff began using the Ortho Evra birth control patch in April of 2004. After 9 months of use, she was hospitalized and diagnosed with a pulmonary embolism and a deep vein thrombosis on December 25, 2004. As a direct result of the deep vein thrombosis and bilateral pulmonary emboli she suffered while using Ortho Evra, the plaintiff is precluded from using any hormone therapy treatment for contraception and she is more inclined to experience future medical complications as a result of the injuries sustained during the use of the Ortho Evra birth control patch. Additionally, the plaintiff has been told by her physicians that the tissue in the left lower lobe of her lung has been damaged from the pulmonary emboli she suffered while using Ortho Evra and she may experience risk of infection in that lung in the future.

The Ortho Evra birth control patch became commercially available in 2002 and has been prescribed to more than 4 million women since its launch. The Patch was marketed to consumers as providing the same safety profile and efficacy as the birth control pill in preventing pregnancy, but with more convenience than birth control pills because it is worn on the skin for three consecutive weeks, with the fourth week being “Patch free.”

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On September 20, 2006, Johnson & Johnson admitted in its revised product labeling that women on the Patch may be at greater risk of developing blood clots in the lungs and legs than women using birth control pills. In fact, a study sponsored by Johnson & Johnson indicates that the Patch may expose women to a doubling of the risk of blood clot injuries. On November 10, 2005, Johnson & Johnson announced a change in the Ortho Evra warning label to disclose that women who use the Patch are exposed to approximately 60% more estrogen than those using an oral hormonal contraceptive. This increased exposure to estrogen makes the Patch comparable to the high-dose estrogen forms of the Pill that the FDA required to be removed from the market in 1988.

Plaintiff alleges that at the time of use of Ortho Evra, Johnson & Johnson knew or should have known that the use of the Patch created an increased risk to consumers of serious personal injury, including stroke, pulmonary embolism, blood clotting, and even death. Johnson & Johnson’s knowledge of the risks involved with using the Ortho Evra birth control patch and their failure to warn consumers solidifies their reckless disregard for the safety of the women using Ortho Evra.

Burg Simpson attorneys, Michael Burg and Janet Abaray, have been appointed as the lead counsel for the nationwide multidistrict litigation brought against Johnson & Johnson. Burg Simpson is investigating numerous cases and preparing to file more cases in upcoming weeks.

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Ortho Evra Birth Control Patch - Over 1,000 Claimants..

November 14, 2006

Not so for 23 women who have allegedly died as a result of using the Ortho Evra birth control patch. This article, published by the No Room for Contraception Campaign, provides an update to the ongoing issue of lawsuits over Ortho Evra:

“Serious health problems have been associated with Ortho Evra including fatal and non-fatal blood clots, strokes, heart attacks, and death. From April 2002 to December 2004, over 27,974 ‘adverse effects’ were reported by users of Ortho Evra. Many of the complaints are serious, and the patch is alleged to be responsible for over 23 deaths, including the death of 14 year old Alycia Brown.”

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It’s interesting to find out that the FDA, “big pharma”, and medical professionals consider non-fatal and fatal blood clots as ‘acceptable risks’ of oral contraception.

If you or anyone you know has suffered ill effects from the patch, contact one of the law firms:

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Birth Control Pill May Raise Breast Cancer Risk

November 1, 2006

“I think women should know about this risk, and they are not being told,� researcher Chris Kahlenborn, MD, of Altoona Hospital in Altoona, Pa., tells WebMD.

“Anyone who is prescribing oral contraceptives has a duty to tell women that 21 out of 23 studies showed an increased risk.�

Breast cancer is most often diagnosed in women over the age of 50, but cancers that occur in younger women tend to be more aggressive. It is the leading cancer killer among women between the ages of 20 and 59 in the U.S.

Kahlenborn says he conducted the analysis because he believes far too few women know the risks associated with oral contraceptive use.

“As I studied the medical literature, I noticed that a trend appeared,� he says. “Namely, oral contraceptive use prior to first full-term pregnancy seemed to consistently increase the risk of premenopausal breast cancer. Although the trend was apparent, premenopausal women have continued to hear that oral contraceptives are safe.�

Women who take oral contraceptives have a slightly increased risk of developing breast cancer early in life, with the risk being greatest for women who use oral birth control before they have their first child, a new analysis suggests.

Researchers combined the findings from 34 previous studies designed to examine the impact of oral contraceptive use on breast cancer diagnosed before menopause.

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Twenty-one of 23 studies that followed women who took oral birth control before having their first child showed an increased risk of early breast cancer.

Mis-Conceptions: Debunking Birth Control Myths

Measuring Risk

Based on these studies, the researchers concluded that taking oral contraceptives before a first full-term pregnancy increases premenopausal breast cancer risk by 44 percent, compared with women who have never used oral contraceptives.

The increase in risk was 52 percent among women who took the pill for four years or more before having their first child.The 34 studies chosen for the analysis included women who were premenopausal or younger than 50 whose breast cancers had been diagnosed during or after 1980.

Studies examining breast cancers diagnosed before this were excluded in an attempt to approximate the risk with oral contraceptives as they are currently prescribed.

When all the studies were combined, use of oral birth control was associated with a 19% overall increased risk of breast cancer diagnosed before menopause. But the increase in risk more than doubled among women who took oral contraceptives before a first pregnancy.

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Birth control for bears tricky and expensive, study finds

November 1, 2006

A new report to the Department of Environmental Protection by three wildlife and contraception vaccine experts declares using fertility control to manage New Jersey’s black bear population would be costly and ineffective.

The report, released yesterday, comes as Gov. Corzine delays a final decision on a December bear hunt, saying he wants to give the DEP more time to consider alternatives, including fertility control.

The study, contracted by the DEP a year ago, may already provide the answer.

“Although fertility control has shown considerable promise for managing certain wildlife populations, such as urban deer,” the report said, “attempting to manage bear populations in this manner would be very difficult and expensive, and would almost certainly fail.”

The researchers found capturing an adequate number of black bears in a specific area for fertility treatment would be the main challenge and expense.

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The report found the current cost incurred by the Division of Fish and Wildlife to capture bears is $1,000 or more per bear, and that is for the most vulnerable and easily captured bears. Should the state try to capture a large proportion of bears, the cost per bear “would increase significantly.”

While fertility control efforts have worked on deer and wild horse populations, they have never been tried on bears in the wild, according to wildlife experts. And only one vaccine, which has been tried on male dogs and left them sterile, and vasectomies are approved for bear fertility control by the federal government.

The report, received by the DEP in September and made public yesterday, surfaces just as Corzine has taken a controversial position in opposition to a bear hunt sportsmen and many residents of New Jersey’s northwest region want.

Sportsmen’s groups are considering taking the state to court in the hope of gaining a ruling allowing a hunt in early December.

Most of New Jersey’s estimated 3,200 bears can be found in Hunterdon, Sussex, Warren, Morris and Passaic counties. More than 300 bears were killed in a hunt in the region last December.

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