четверг, 30 июня 2011 г.

Some Doctors Stop Prescribing Ortho Evra Birth Control Patch After FDA Warning, Wall Street Journal Reports

Some doctors are no longer writing prescriptions for Johnson & Johnson's Ortho Evra contraceptive patch after FDA issued a warning earlier this month regarding possible health risks for women using the patch, the Wall Street Journal reports (Chaker, Wall Street Journal, 11/22). FDA on Nov. 8 warned that women who use the patch have a higher risk of experiencing blood clots and other side effects than previously stated because the patch exposes users to about 60% more estrogen than standard birth control pills. The Ortho Evra patch -- which is manufactured by Ortho-McNeil, a subsidiary of J&J -- is worn on the skin for one week at a time, delivering progestin and estrogen to the blood stream. The Associated Press in July reported that, according to FDA records it obtained through a Freedom of Information Act request, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. FDA and Ortho-McNeil said they were aware of a possible increased risk of blood clots among patch users but said the patch was as safe as birth control pills (Kaiser Daily Women's Health Policy Report, 11/11). Some doctors and health care providers "don't want to take any chances" with Ortho Evra and are no longer offering new prescriptions, and others are advising their patients who currently are using the patch to switch to another form of birth control, according to the Journal. Lee Shulman, incoming board chair of the Association of Reproductive Health Professionals and a consultant to Ortho-McNeil, said a "decrease in use" of Ortho Evra can be expected. However, he said switching from the convenience of a weekly contraceptive to a daily pill might lead to unplanned pregnancies, adding, "There is no evidence that there's an increased risk of bad events" with Ortho Evra. The company currently is conducting two large-scale studies on the effects of Ortho Evra (Wall Street Journal, 11/22).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Local Anesthetic For Cesarean Section Reduces Need For Painkillers

Giving a local anaesthetic during a Caesarean section helps manage pain after the operation and can reduce consumption of painkillers, according to Cochrane Researchers. The researchers recommend local anaesthetics as part of integrated pain management strategies for Caesarean section operations, provided that consideration is given to the cost.



"This review is particularly important in light of the growing number of women giving birth by Caesarean section," says lead researcher, Anthony Bamigboye, of the Department of Obstetrics and Gynaecology at the University of Witwatersrand in Johannesburg, South Africa. "Improved pain relief allows mothers to bond with their babies and begin breastfeeding more quickly."



Caesarean sections account for around a quarter of all births in the US, Canada and the UK. Local anaesthetics can be given, in addition to general or regional anaesthetics, to help manage pain during and after operations. The anaesthetic is either injected to block nerves in the abdominal wall or applied directly to the wound as an anaesthetic solution.



The researchers reviewed data from 20 studies that together involved 1,150 women who gave birth by Caesarean section in both developing and developed countries. They found that women treated with local anaesthetic as well as local or regional anaesthesia did not require as much morphine or other opioid drugs for pain relief after their operations. When non-steroidal anti-inflammatory drugs were also given, pain was reduced further.



One concern, however, is the additional cost of giving local anaesthetic. "None of the trials in this review addressed the cost implications of increasing use of local anaesthetic," says Bamigboye. "A cost benefit analysis is needed to find out whether increased expenditure on theatre time and local anaesthetic can be offset by reductions in postoperative painkillers."



Source:
Jennifer Beal


Wiley-Blackwell

US Government Funding for Family Planning Declines as More Women Need Publicly Funded Contraception, Report Says

A "widening gap" exists between women's contraceptive needs and the availability of subsidized family planning services, according to a report released on Tuesday by the... Alan Guttmacher Institute, the AP/Fort Wayne Journal Gazette reports. In 2002, 16.8 million women needed subsidized contraception, but clinics only were able to provide family planning services to 40% of such women, according to the report (Crary, AP/Fort Wayne Journal Gazette, 3/1). In addition, since 1994, 27 states and the District of Columbia have seen their overall level of funding for family planning services remain the same or decrease. In addition, Medicaid programs, which have the "burden of meeting women's health care needs" and comprise nearly 67% of all federal and state family planning funding, have had to cut funding since the early 2000s, according to an AGI release. The disparity between women's needs and program funding is occuring in part because of "greater hostility" to women's reproductive health issues in Congress and state legislatures, according to the release. "Today, half of all women who are at risk for unintended pregnancy if they don't use birth control need publicly funded family planning services," Rachel Benson Gold, AGI director of policy analysis, said, adding, "Yet in Congress and the states, we are facing a potential 'perfect storm' that could make it harder for these women to get contraceptives, counseling and STD testing that help them plan their pregnancies and protect their health" (AGI release, 3/1).


"Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/repro The Kaiser Daily Reproductive Health Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Bionovo To Present Positive Results From Phase 2 Trial Of Menerba For Vasomotor Symptoms To The International Community

Bionovo, Inc. (Nasdaq: BNVI) announced it will be presenting the positive results from the phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 8th Annual European Society for Gynecology (EGS) in Rome, Italy.


The phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting moderate to severe hot flashes. Highlights from the trial include:



-- After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04).



-- There was a clear dose response trend in multiple efficacy analyses.



-- Menerba reduced the number of times women were awakened from sleep due to hot flashes (night sweats). The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05).



-- Compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication.



-- The only statistically significant adverse event was "transient loose stools" (12% on Menerba vs. 3% on placebo).



-- During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile.



-- After 12 weeks of treatment, participants taking Menerba experienced lower body mass index and weight compared to those on placebo.


"The novel mechanism of action, the positive efficacy results and the excellent safety profile, make Menerba an extremely promising drug candidate for postmenopausal women. While 40 million women in the United States suffer from hot flashes and night sweats leading to the second largest indication in Women's Health domestically, the opportunity is significantly increased when we factor in international opportunities. We look forward to introducing Menerba to a wider scientific, clinical and pharmaceutical community, where there is demonstrated interest in finding an alternative to hormone therapy on an international basis," said Dr. Mary Tagliaferri, M.D., President and Chief Medical Officer at Bionovo.


"I am very encouraged by the findings of this clinical trial. The novel mechanism of action and phase 2 efficacy and safety results are encouraging and warrant further investigation. Presuming the phase 3 results confirm the findings in the phase 2 trial, there seems no question that, if approved, Menerba's safety and efficacy profile could make it a first line therapy in an indication that clearly needs alternatives," said Wulf Utian, M.D., Ph.D., D.Sc., founder and President Emeritus of the North American Menopause Society and Menerba's phase 3 Principal Clinical Investigator.















Menerba


Menerba is an estrogen receptor (ER) beta selective drug developed as an alternative to postmenopausal hormone products currently on the market, which are both ER beta and ER alpha agonists that have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with ER alpha activation and that ER beta blocks the growth promoting effects on breast cancer cells. Bionovo recognized the opportunity to commercialize a product that would be equally effective, with an improved safety profile compared to traditional hormone therapy. The clinical trial results have been evaluated by an independent Data and Safety Monitoring Board and the drug candidate has passed through a standard two-phase examination for safety.


Bionovo, Inc.


Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI".


Forward Looking Statements


This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected.


Source: Bionovo, Inc

For Women With Existing Heart Risk, Estrogen Therapy Could Be Dangerous

Hormone therapy could accentuate certain pre-existing heart disease risk factors and a heart health evaluation should become the norm when considering estrogen replacement, new research suggests.



The research also showed that in women without existing atherosclerosis, hormone therapy use included some positive effects on lipids but also some negative effects related to heart health, said MaryFran Sowers, lead researcher and professor of epidemiology at the University of Michigan School of Public Health.



The U-M study came about, Sowers said, in trying to explain what's behind the so-called timing hypothesis. The timing hypothesis suggests that if a woman implements a hormone therapy program within six years of her final menstrual period, this narrow window is enough to deter heart disease from developing with the onset of menopause. But the U-M findings suggest that explanation isn't quite so simple, Sowers said.



Even within the six-year window, there were negative aspects related to heart disease. While the positive outcomes on HDL and LDL cholesterol levels were observed, Sowers said, researchers also saw negative outcomes in terms of the inflammation process - which can be related to heart disease.



Sowers said the research shows it's critical for women considering hormone therapy to discuss their heart health with their doctor.



"If the woman walks into the doctor's office with a certain degree of (heart disease) burden already, then she and her health care provider may decide that hormone therapy adds too much to the burden," Sowers said. "If she doesn't have that burden, they may decide that hormone therapy is an acceptable burden.



"The woman should say to her health care provider, 'What kind of information do we need to gather in order to make an informed decision about whether or not hormone therapy should be pursued,'" Sowers said. '"I understand there could be some heart disease risk, but that the risk may be based upon where I am now, and can you tell me where that is?'"



Heart disease risk can be measured through lipid panels, which are standard, but also by measuring inflammation markers, Sowers said. Tests for inflammation markers exist but their measurement isn't standard when a women is considering hormone therapy, Sowers said.



Hormone therapy has been controversial for years, and there was a time when there was an almost knee jerk reaction against it, Sowers said. This backlash occurred after the findings from the Women's Health Initiative study showed that some women on estrogen therapy had increased heart disease risk. The six-year timing hypothesis was an attempt to explain the findings in the WHI study, Sowers said.



The University of Michigan School of Public Health has been working to promote health and prevent disease since 1941, and is consistently ranked among the top five public health schools in the nation. Faculty and students in the school's five academic departments and dozens of collaborative centers and initiatives are forging new solutions to the complex health challenges of today, including chronic disease, health care quality and finance, emerging genetic technologies, climate change, socioeconomic inequalities and their impact on health, infectious disease, and the globalization of health. Whether making new discoveries in the lab or researching and educating in the field, our faculty, students, and alumni are deployed around the globe to promote and protect our health.







Related Links:


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Source: Laura Bailey


University of Michigan

Women With Cancer Have Options For Preserving Fertility

Young women undergoing cancer treatment have an increasing number of options for preserving their fertility, a leading researcher told attendees today at the 58th Annual Clinical Meeting of The American College of Obstetricians and Gynecologists.


Thanks to a new medical discipline known as oncofertility, the reproductive outlook for women cancer patients is becoming as good as for men, who long have had the option of banking their sperm, according to Teresa K. Woodruff, PhD, of Northwestern University Feinberg School of Medicine in Chicago, in her lecture "Oncofertility: The Preservation of Fertility Options for Young People with Cancer." A promising new technique for preserving ovarian tissue has the potential to safeguard the future fertility even of very young girls undergoing cancer treatment, she said.


Dr. Woodruff, the Thomas J. Watkins professor of obstetrics and gynecology at Northwestern, coined the term "oncofertility" to describe oncologists and reproductive specialists working hand-in-hand to preserve patients' fertility while treating their disease. She is the leader of the Oncofertility Consortium, which draws on cutting-edge research to counsel patients on fertility options. Headquartered at Northwestern and supported by the National Institutes of Health, the Consortium operates through more than 50 centers in 29 states.


About 140,000 people under age 45 are diagnosed with cancer each year in the United States, Dr. Woodruff said. "There are no good numbers for how many are threatened with loss of fertility, because it depends on the course of the disease and treatment prescribed," she said.


Chemotherapy affects fertility by attacking follicles in the ovaries that contain a woman's lifetime supply of eggs, Dr. Woodruff explained. Because follicles grow rapidly, they are especially sensitive to cancer drugs, which target fast-growing cancer cells. If drugs damage only mature follicles and the eggs they contain, a woman may stop having periods during treatment but resume menstrual cycles after she completes chemotherapy. But if drugs destroy all the follicles, she will be left sterile.


Radiation treatment to the abdomen can damage the follicles, as well as the uterus. If directed to the head, radiation can impact fertility by blocking production of reproductive hormones in the brain.


Many women with cancer who want to safeguard their fertility opt for egg or embryo banking, which oncofertility specialists are making available to more patients. "Egg banking also is much more effective now than five or ten years ago, because we can freeze the eggs better," Dr. Woodruff said.


However, egg banking is not suitable for girls who have not yet gone through puberty or for women who cannot postpone cancer treatment while they take hormones to stimulate production of mature eggs. A new option called ovarian tissue cryopreservation sidesteps these problems. Doctors remove an ovary via laparoscopy, an outpatient surgery that takes 30 to 45 minutes. The procedure requires no hormones and does not delay cancer treatment for more than a couple of days. Tissue from the removed ovary is sliced into strips, frozen, and stored. Because a girl is born with all the eggs she will ever have, this technique could be used on a child as young as one year of age, Dr. Woodruff said.


Following cancer treatment or whenever a woman is ready to have a child, the ovarian tissue can be thawed and transplanted back into her body. "Worldwide, there have been about 20 live births resulting from this procedure, including those among some cancer patients," Dr. Woodruff said. Because transplantation does carry the potential risk of reintroducing cancer cells back into the body, it is not recommended for women who have had ovarian cancer or blood system cancers, such as leukemia or lymphoma.


Researchers are working hard to perfect a safer use of preserved ovarian tissue called in vitro follicle maturation, which may be available in several years. "Instead of growing follicles in a woman's body, we grow them in a dish," Dr. Woodruff explained. "That would allow us to eliminate the possibility of reintroducing the cancer she's just survived. We've produced live, healthy offspring in mice and have gotten good quality eggs in both baboons and rhesus monkeys. Human follicles also have adapted rapidly to the in vitro system. They grow rapidly and are fairly easy to work with."


Source

American College of Obstetricians and Gynecologists

States Making Gains In Cervical Cancer Prevention Efforts, Report Says

Many states are making gains in cervical cancer prevention efforts, but significant economic and racial disparities remain, according to a Women in Government report released Tuesday, HealthDay News reports. According to the report, 67% of states experienced a decrease in cervical cancer incidence and 51% experienced a drop in cervical cancer mortality (Gardner, HealthDay News, 1/16). According to a Women in Government release, even though HPV vaccines have been developed, "screening will still be critical to protect women against cervical cancer caused by HPV types not covered by the vaccine, for women already exposed to HPV types targeted by the vaccine and for women who do not receive the vaccine." The findings of the third annual report, titled, "Partnering in Progress 2007: The 'State' of Cervical Cancer Prevention in America," are based on testing rates, rates of uninsured women, coverage of screening technology in state health care programs and legislative action on the issue (Women in Government release, 1/16). Cervical cancer incidence and mortality rates for black and Hispanic women were higher than rates for white women in the majority of states, the report found. Minnesota was the only state to receive a score of "excellent," and Alabama, Connecticut, Illinois, Maine, North Carolina and Rhode Island also received high scores from the report. These states had Medicaid programs that cover HPV testing for women ages 30 and older, at least 87% of "age-appropriate" women screened for cervical caner in the last three years and at least 82% of women with health insurance. According to the report, 49% of states experienced an increase in the rate of uninsured women. Idaho received the lowest score, followed by South Dakota and Utah, the report found. "I'm pleased that the majority of states, including the District of Columbia, saw a decrease in cervical cancer incidence and mortality, and we also have a number of states that put cervical cancer prevention legislation into place last year," Susan Crosby, president of Women in Government, said, adding, "Unfortunately, we still have a long way to go." In 2006, 25 policy measures were introduced nationwide that addressed cervical cancer prevention. About 3,700 U.S. women died of cervical cancer last year (HealthDay News, 1/16).

The report is available online.



"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

WISE study starts in Toulouse: 60 days of bed-rest for terrestrial female astronauts

Since Saturday, 19 March, the study entitled Women International Space Simulation for Exploration (WISE) has been fully
under way. All participants in the first of two campaigns have been lying in bed, tilted head down at an angle of 6? below
horizontal, so that their heads are slightly lower than their feet.



This position results in physiological changes that also occur in astronauts during space flight. The study will assess the
roles of nutrition and combined physical exercise in countering the adverse effects of prolonged gravitational unloading by
bed-rest.


The first volunteers arrived at the MEDES Space Clinic in Toulouse on 22 February for the start of the collection of
physiological data, which will serve as the baseline data throughout the whole study. This preliminary period lasted 20 days,
after which the first two volunteers went to bed; the last two, who arrived on 27 February, did so on 19 March.


More than 1600 women responded to the ESA call for candidates, which closed in January. As planned, twelve women were
selected for this first campaign. They come from France, Great Britain, Germany, Finland, The Netherlands, Poland, and the
Czech Republic, so that the WISE study also attracted great interest in the new member countries of the European Union.



This study is a joint venture between the European Space Agency (ESA), the French space agency (CNES), the National
Aeronautics and Space Administration (NASA) and the Canadian Space Agency (CSA). It is being carried out by MEDES, the French
Institute for Space Medicine and Physiology, in the clinical research facility at the Rangueil hospital in Toulouse, France.




WISE needs 24 female volunteers altogether, who will remain in bed for a total duration of 60 days. The test subjects will be
divided into three groups of eight. One will be the control group, receiving no extra stimulus over the course of the
bed-rest period. The second group will undertake an exercise programme whilst in bed. The third will receive a nutritional
supplement throughout the 60 days.


For the 20 days prior to the bed rest period, the test subjects will take part in the collection of baseline data. During the
20 days following the bed-rest period they will undergo similar tests for comparison with the baseline data. The WISE study
is being conducted in two campaigns, with 12 volunteers in each. The second campaign starts in September. Volunteers can
still apply.


The data collected by WISE will be used to draw conclusions about such aspects as muscle condition, blood parameters,
cardiovascular condition, coordination of movements, changes in immune system, bone formation and psychological wellbeing.
External experts reviewed all scientific protocols of the study prior to selection, and the responsible French ethical
committee in Toulouse has approved the integrated study design of WISE.


With the European Space Agency's future plans for human space exploration, the results expected from WISE will prove valuable
in planning long-duration human missions. This research will also have clinical significance on Earth, advancing knowledge
and pointing to improved methods of assisting recovery by bedridden patients. Studying the early effects of reduced activity
on a molecular level is expected to provide further evidence of the benefits of regular exercise in the prevention of
conditions like type 2 diabetes and high blood pressure.


ESA has created an information website on WISE at: spaceflight.esa.int/wise


Details of the requirements to be met by candidates for the second campaign, which starts in September, the conditions of
participation and the application form for the female bed-rest study can be obtained at: medes.fr/ltbrw. Information can also be obtained by phone: +33 825 82 54 84 for international
calls (?0.20/min) and 0 825 82 54 84 for calls from inside France (?0.15/min).


For further media information please contact:


Franco Bonacina

ESA Media Relations Division

Paris (France)

Tel: +33 1 5369 7155

Fax: +33 1 5369 7690


Dieter Isakeit

Erasmus User Centre and Communication Office

Directorate of Human Spaceflight, Microgravity and Exploration Programmes

Noordwijk (The Netherlands)

Tel: +31 71 565 5451

Fax: +31 71 565 8008

e-mail: dieter.isakeitesa.int


European Space Agency

esa.int

Pfizer Announces Results From Trial Of AROMASIN In Postmenopausal Women With Hormone Sensitive Early Breast Cancer

Pfizer today announced results from a first planned analysis of the TEAM (Tamoxifen, Exemestane, Adjuvant, Multicenter) trial. TEAM was originally designed in 2001 as a comparison of 5 years of upfront AROMASIN® (exemestane tablets) vs. tamoxifen. In 2004, based on results of Intergroup Exemestane Study (IES) the TEAM trial design was revised; the tamoxifen arm was converted into a tamoxifen/AROMASIN sequencing arm. This analysis presented at SABCS represents the first of two co-primary endpoints that will be reported from this trial. The first co-primary endpoint compares early events by measuring disease-free survival (DFS: disease progression or death) at 2.75 years in 9,775 patients randomized to initial therapy with either tamoxifen or AROMASIN.


The analysis of DFS at 2.75 years demonstrated an 11 percent reduction in the risk of DFS events in favor of AROMASIN (HR=0.89; 95% CI, 0.77-1.03). This difference was not statistically significant (p=0.118). A second planned analysis of DFS after five years of therapy is expected in late 2009. Results from TEAM trial sub-studies were also presented at SABCS.


"The TEAM data contribute to the growing knowledge of the role of aromatase inhibitors in the treatment of early breast cancer," said Dr. Steve Jones, medical director, U.S. Oncology Research, Houston and Texas Oncology, Dallas, TX. "Clinicians take into account patient profile, clinical evidence and guidelines when determining the optimal treatment regimen for patients, and should consider these new data as treatment strategies are evaluated."


Additional TEAM Study Results


-- Additional secondary analyses demonstrated a:


- 15 percent reduction in the risk of recurrence-free survival(RFS) events in favor of AROMASIN (HR=0.85; 95 percent CI, 0.72-1.00; p=0.049)

- 19 percent improvement in the time-to-distant metastasis in favor of AROMASIN (HR=0.81; 95 percent CI, 0.67-0.98; p=0.026)


-- When adjusting the primary DFS analysis accounting for discontinuation rates and patients who switched prior to 2.5 years, an analysis showed a 17 percent reduction in the risk of DFS events at 2.75 years in favor of AROMASIN (HR=0.83; 95 percent CI, 0.71-0.97; p=0.021)


- Treatment discontinuation rates for tamoxifen and AROMASIN were 29.5 percent and 18.9 percent, respectively

- 754 patients in the tamoxifen arm switched prior to 2.5 years


-- The most common side effects reported in the TEAM trial were consistent with the expected safety profile of these agents. Side effects were coded by NCI CTC (version 2), and included for tamoxifen and AROMASIN (all grades), respectively: hot flashes (33 percent, 28.5 percent); arthralgias (9.2 percent, 18.4 percent); fatigue (16 percent, 16.8 percent); pain (13.2 percent, 14.6 percent); infection (13 percent, 11.9 percent)















-- The incidence of bone-related side effects for tamoxifen and Aromasin, respectively, were:


- Osteoporosis (2.2 percent, 4.9 percent)

- Spine/wrist/hip fractures (0.5 percent, 0.6 percent)


TEAM Sub-studies


-- Data from the TEAM Pathology study support the prognostic value of PgR in ER+ early breast cancer

-- Results from additional TEAM sub-studies (bone, cognitive function, quality of life and physical activities) were also presented


About the TEAM Trial

TEAM is a randomized, open-label, multinational trial in 9,775 postmenopausal women with hormone sensitive early breast cancer. The TEAM trial represents an international collaboration of investigators in 9 countries who conducted the trial following protocols representative of local clinical practice.


TEAM was originally designed in 2001 as a comparison of 5 years of upfront AROMASIN® (exemestane tablets) vs. tamoxifen. In 2004, based on results of IES the TEAM design was revised; the tamoxifen arm was converted into a tamoxifen/AROMASIN sequencing arm. The modified design includes two co-primary endpoints comparing DFS in a pre-planned pooled analysis:


-- At 2.75 years in patients randomized to initial therapy with either tamoxifen or AROMASIN (presented at SABCS 2008)

-- In patients treated with AROMASIN for 5 years versus patients who received sequential therapy of tamoxifen for 2.5-3 years followed by AROMASIN for a total of 5 years


Secondary endpoints included overall survival, time to new primary breast cancer, recurrence-free survival, time to new primary cancers (other than breast) and safety and tolerability. The TEAM trial includes 19 prospectively planned observational and translational research sub-studies.


"Aromasin has had an important impact on the treatment of women with breast cancer since its approval," said Dr. Ray Urbanski, senior medical director/Oncology Group Lead. "We are proud of our heritage in breast cancer, and continued commitment to develop new treatment options to meet the unmet needs of these patients."


About Aromasin® (exemestane tablets)


Aromasin is the only aromatase inhibitor indicated for sequential therapy in postmenopausal women with HR positive early breast cancer after 2-3 years of tamoxifen for a total of 5 years of adjuvant therapy. The use of Aromasin in this setting is supported by the landmark IES trial. Aromasin is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.


Important Aromasin®(exemestane tablets)Safety Information


AROMASIN should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents. Dose modification is recommended for patients who are receiving certain medications, including strong CYP 3A4 inducers. In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN than either tamoxifen or placebo.


About Pfizer Oncology


Pfizer Oncology is committed to the discovery, investigation and development of treatments and currently has 22 innovative compounds in clinical development across four platforms. By leveraging the strength of our resources and scientific talent, Pfizer Oncology strives to discover and develop novel treatment options to improve the outlook for oncology patients. Pfizer currently devotes more than 22 percent of its total R&D budget to the field of oncology, investing annually in worldwide research initiatives. We also partner with healthcare providers, governments and local communities around the world to provide better quality healthcare and health system support. For more information on the above information, please visit Pfizer.


For more information on AROMASIN and Pfizer Oncology, including full prescribing information for AROMASIN, please visit Pfizer.

Pfizer Oncology


View drug information on Aromasin Tablets.

Women Who Are Sexually Satisfied Have Better General Well-Being And More Vitality

Pre- and post-menopausal women who self-rated themselves as being sexually satisfied had a higher overall psychological well-being score and scores for "positive well-being" and "vitality," compared with sexually dissatisfied women in a study of 295 women sexually active more than twice a month. The study, published in The Journal of Sexual Medicine, also uncovered a positive association between age and well-being, but a negative association for general health.



The most commonly reported sexual problems in the area of consensual sexuality in women relate to sexual desire and interest, pleasure and satisfaction, and for most women these are part of the overall sexual experience, and are inextricably related. In contrast to studies of interventions for male erectile dysfunction, benefit of treatment in women with sexual dysfunction cannot be measured simply by the frequency of sexual events, as women frequently continue to be sexually active despite a high level of sexual dissatisfaction. Thus the frequency of self-reported satisfactory sexual events has been used as the primary outcome in recent studies.



To assess whether there was a correlation between sexual satisfaction and well-being, the team of Australian researchers recruited women from the community aged 20-65 who self-identified as being satisfied or dissatisfied with their sexual function. Participants were also asked questions which identified whether they were pre- or post menopausal, with recruitment closed when there was an equal number of women in each of the four subgroups.



"We wanted to explore the links between sexual satisfaction and wellbeing in women from the community, and to see if there was any difference between pre- and postmenopausal women," said lead author Dr Sonia Davison, of the Women's Health Program at Monash University, Australia. "We found that women who were sexually dissatisfied had lower well-being and lower vitality. This finding highlights the importance of addressing these areas as an essential part of women's healthcare, because women may be uncomfortable discussing these issues with their doctor."



"The problem with interpreting this finding is that it is impossible to determine if dissatisfied women had lower well-being because they were sexually dissatisfied, or if the reverse is true, such that women who started with lower well-being tended to secondarily have sexual dissatisfaction," added Davison. "As such, pharmacotherapies aimed to treat sexual dysfunction may have secondary effects on well-being, and the reverse may be true."



As over 90% of women in this study reported their sexual activity involved a partner, and was initiated by the partner at least 50% of the time, the sexual activity of the women may have been affected by partner presence (or absence), partner health, and sexual function, which were not addressed in this study. "The fact that women who self-identified as being dissatisfied maintained the level of sexual activity reported most likely represents established behaviour and partner expectation," said Professor Susan Davis, senior author of this study, also based at the Women's Health Program at Monash University, Australia. "It also reinforces the fact that frequency of sexual activity in women cannot be employed as a reliable indicator of sexual well-being."



"We are proud to publish this extremely important study in women's sexual health" said Dr. Irwin Goldstein, Editor-in-Chief of The Journal of Sexual Medicine. "This large study performed in the community emphasizes the role and importance of women's sexual health in women's overall health and well-being. Previous criticism equated physicians' efforts to improve a woman's satisfaction with her sexual life as medicalization. Dr. Davison's and co-workers' research will help health care professionals appreciate the need for overall women's healthcare to include women's sexual health care."



Source:
Jennifer Beal


Wiley-Blackwell

Mass. Lt. Gov. Urging Gov. To Sign Bill Requiring Hospitals To Offer EC to Rape Survivors, Allow Pharmacies To Dispense EC

Massachusetts Lt Gov Kerry Healey (R) on Wednesday said she will encourage Gov Mitt Romney (R) to sign a measure that would broaden access to emergency contraception, but she did not explicitly endorse any legislation, the... Boston Globe reports. "I am a strong advocate for pro-choice, and I expect to bring that voice to the table when the governor and I and his other advisers sit down to discuss the bill," she said, adding that Romney "has always said that he was personally pro-life, and I've always said that I was personally pro-choice" (Ebbert, Boston Globe, 7/14). The state Legislature currently is considering legislation (SB 2073/HB 1643) that would require hospital emergency departments to offer emergency contraception to rape survivors and allow pharmacists to dispense EC to women without a doctor's prescription (Boston Globe, 7/14). The Senate-approved version of the measure would require hospitals to provide medically accurate, written information about EC -- to be prepared by the state public health commissioner -- to all female rape survivors. Hospitals also would be required to provide EC to any rape survivor who requests it. In addition, pharmacists wishing to dispense EC without a doctor's prescription would have to complete a specialized EC training program approved by the state public health commissioner. The House-approved version of the measure differs from the Senate version in that it would exempt privately controlled hospitals that object to dispensing EC on moral or religious grounds. The House version also would require hospitals to report to the state Department of Public Health (Kaiser Daily Reproductive Health Report, 7/8). The bills have been sent to a House-Senate conference committee to work out the differences between the two versions (Boston Globe, 7/14).

Romney's Position
Healey on Wednesday did not offer any insight into Romney's position on the measure. Romney during his 2002 gubernatorial campaign suggested that he favored wider access to EC, which can prevent pregnancy if taken within 72 hours of sexual intercourse, but has since said he must examine the resulting bill to ensure it does not affect state abortion laws. Romney's refusal to take a stance on the issue has led to discussion over whether he is becoming more conservative, especially on abortion-related issues, as he considers a 2008 presidential run, the AP/Needham Daily News Transcript reports (Emery, AP/Needham Daily News Transcript, 7/14).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Flaxseed Shows Potential To Reduce Hot Flashes

Data from a new Mayo Clinic (mayoclinic.edu) study suggest that dietary therapy using flaxseed can decrease hot flashes in postmenopausal women who do not take estrogen. The findings from the pilot study are published in the summer 2007 issue of the Journal of the Society for Integrative Oncology.


A hot flash is often described as a flush of intense warmth across much of the body that may be accompanied by sweating, reddening of the skin, or, occasionally, cold shivers. Hot flashes occur in varying frequency and duration, even during sleep, and often cause or accompany sleep deprivation, anxiety and irritability.


"Hot flashes are a bothersome issue for women experiencing menopause," says Sandhya Pruthi, M.D., (mayoresearch.mayo.edu/mayo/research/staff/pruthi_s.cfm) Mayo Clinic breast health (cancercenter.mayo.edu) specialist and the study's primary investigator. "We hope to find more effective nonhormonal options to assist women, and flaxseed looks promising."


Although until recently hormone replacement therapy was the most commonly prescribed treatment for hot flashes, unwanted side effects have led to the search for nonhormonal solutions. Several effective nonhormonal drug therapies have been identified, but they are not always effective, and not all women can use them because of side effects. These limitations have led researchers to explore non-drug agents. They have studied a variety of herbal and dietary supplements in randomized, placebo-controlled trials, including vitamin E, black cohosh and soy, but none has shown to produce any significant reduction in frequency or severity of hot flashes.


The 29 participants in Mayo's clinical trial were women with bothersome hot flashes who did not want to take estrogen because of a perceived increased risk of breast cancer. They also had not received (in the preceding four weeks) antineoplastic chemotherapy, androgens, hormonal agents, or other herbal supplements, including soy. Some patients did not complete the trial, but full data for six weeks of flaxseed therapy, consisting of 40 grams of crushed flaxseed ingested daily, was obtained from 21 of them.


Participants were asked questions that the researchers translated into a hot flash score -- a combined measure of frequency and severity. The frequency of hot flashes decreased 50 percent over six weeks, and the overall hot flash score decreased an average 57 percent for the women who completed the trial. Participants also reported improvements in mood, joint or muscle pain, chills and sweating; which significantly improved their health-related quality of life.















"We are quite pleased with the improvements noted by these women in their quality of life," says Dr. Pruthi. "Not only does flaxseed seem to alleviate hot flashes, but it appears to have overall health and psychological benefits as well."


Dr. Pruthi's team chose to research flaxseed because it is a phytoestrogen (plant-based estrogen source). Flaxseed contains lignans and omega-3 fatty acids. Lignans are antioxidants with weak estrogen-emulating characteristics, and have some anti-cancer effects. Flaxseed also appears to have anti-estrogen properties and has been shown in some recent research trials to decrease breast cancer risk. The researchers hypothesized that patients taking flaxseed might gain some relief for hot flashes.


This pilot trial was designed to determine the effectiveness of flaxseed in alleviating hot flashes and identify possible side effects. Dr. Pruthi cautions that the results are preliminary and taking flaxseed may not give relief to every woman suffering hot flashes.


"While results were promising, we have more research to conduct," she says. "Oftentimes, pilot studies show promising results that upon further study in a large, randomized placebo-controlled study turn out to be much less remarkable."


Dr. Pruthi's research team hopes to open a new, larger clinical trial in 2008 evaluating flaxseed against a placebo to better refine the results, and to hopefully confirm flaxseed as a new treatment option for hot flashes in women.


Other Mayo Clinic researchers included Charles Loprinzi, M.D.; Susan Thompson; Paul Novotny; Debra Barton, Ph.D.; Lisa Kottschade; Angelina Tan; and Jeff Sloan, Ph.D. The flaxseed study was supported in part by the Susan G. Komen Breast Cancer Foundation.


For more information on clinical trials available at Mayo Clinic, please visit clinicaltrials.mayo.edu.


Mayo Clinic

200 First St. SW

Rochester, MN 55902

United States

mayoclinic

Blogs Comment On Supreme Court Vacancy, Antiabortion-Rights Democrats, Other Topics

The following summarizes selected women's health-related blog entries.

~ "History Says GOP's Court Fight Will Be Futile," Steve Kornacki, Salon's "The Numerologist": Republicans' immediate response to the retirement of Supreme Court Justice John Paul Stevens was "hardly a surprise," including Senate Minority Leader Mitch McConnell's (R-Ky.) pledge to use the confirmation process to derail President Obama's nominee, Kornacki writes. However, "history says it will be just about impossible for the GOP to thwart whomever Obama tabs as Stevens' successor -- unless some sort of personal scandal erupts," Kornacki argues, noting that Robert Bork is the only Supreme Court nominee in the last 25 years to be defeated in the Senate. "Otherwise, recent nominees who have been targeted on purely ideological grounds have all survived," Kornacki says, adding, "There's no reason to think Obama's nominee to replace Stevens will fare much differently." Republicans hold 41 Senate seats, "so it would take 10 Democratic defections to upend [Obama's] pick," and "recent history shows that a nominee only loses support from members of the president's party when some sort of personal issue crops up," Kornacki writes (Kornacki, "The Numerologist," Salon, 4/9).

~ "Bart Stupak's Departure: The End of Pro-Life Democrats?" David Gibson, Politics Daily's "Disputations": Gibson discusses whether antiabortion-rights Rep. Bart Stupak's (D-Mich.) announcement that he will not run for re-election is "a win for antiabortion groups" or "at least a measure of vindication for conservatives after what they saw as the huge setback of the health care passage." Stupak already faced a primary challenge from former Charlevoix County, Mich., Commissioner Connie Saltonstall, who supports abortion rights, Gibson notes. "While a Saltonstall victory in the primary -- and the general election -- would please pro-choice activists to no end, Democratic sources say the party is more likely to push other candidates who would have a better shot at winning in November in a district that tends to be pro-life and blue-collar," he continues. However, "it is also possible that so many bridges had been burned between pro-life Democrats and pro-life lobbies after the health care vote that Stupak's retirement is only the recognition of a chasm so wide it was unlikely to be narrowed any time soon," Gibson adds. He also writes that Stevens' retirement makes it "likely that abortion rights will flare up again as a central issue during a confirmation hearing this summer, giving Democrats and Republicans more incentive to use abortion as a wedge issue, and more fodder for the fall campaign" (Gibson, "Disputations," Politics Daily, 4/10).














~ "The New Health Care Fight: Abortion Coverage in State Exchanges," Sarah Kliff, Newsweek's "The Gaggle": A "new, state-level battle over abortion coverage has just begun," Kliff writes, adding that it comes "courtesy of Section 1303" of the health care reform law (PL 111-148), "which reiterates states' rights to regulate abortion coverage among their insurers." Although the provision "actually does not give states any rights they didn't have before, ... in the world of abortion politics and policy, it was important for two main reasons," according to Kliff. "First, it drew scrutiny to a relatively dormant area of the abortion debate: insurance coverage," and "[s]econd, it restated the existing laws regarding insurance regulation in a way that homes in on abortion, giving those who oppose abortion rights a specific clause to attack." American United for Life is "[l]eading that charge," she adds. The effect of "opt-out bills ... will vary from state to state," Kliff says, noting that Missouri "already has a law barring nearly all abortion coverage in private insurance," meaning that it is "unclear what an additional opt-out law would do." However, Tennessee has "less stringent laws on abortion coverage, meaning a new law could shape the plans sold on the exchange," Kliff states (Kliff, "The Gaggle," Newsweek, 4/12).

~ "The Long and Short of President Obama's SCOTUS Nominee Lists," Michael Scherer, Time's "Swampland": The White House is "not tipping its hand" as it considers possible nominees to replace retiring Supreme Court Justice John Paul Stevens, Scherer writes, adding that there are "no [official] short lists or long lists." However, "there does seem to be some consensus among outside groups who track this process" that Solicitor General Elena Kagan, U.S. Appeals Court Judges Diane Wood and Merrick Garland, and Secretary of Homeland Security Janet Napolitano are top contenders, according to Scherer. He also posts an "unofficial list of other names from one outside group that is keeping a close eye" on the nomination process. The list includes a "high number of non-judicial, judicial nominees," such as Michigan Gov. Jennifer Granholm (D), Massachusetts Gov. Deval Patrick (D), Attorney General Eric Holder, and Sens. Amy Klobuchar (D-Minn.) and Sheldon Whitehouse (D-R.I.), Scherer writes. "Obama has long spoken of his awareness of the world outside of the law as a key factor in his decision making process," he adds. According to Scherer, Obama said in his statement on Stevens' retirement that he will seek a nominee with "a keen understanding of how the law affects the daily lives of the American people," among other qualities (Scherer, "Swampland," Time, 4/9).

~ "A Question of Values: The Real Abortion Debate," Naomi Cahn and June Carbone, Huffington Post blogs: "Politicians do not like to talk about sex," but "[t]hey most emphatically do not like talking about women's reproductive needs," according to Cahn and Carbone. Every time the issue of contraception arises, "a determined group in Congress changes the subject to abortion," they write. "Contraception is about women's real needs," they write, adding, "It is time we change the subject back." Cahn and Carbone note that Medicaid pays for 40% of all births in the U.S. and that the rate of unintended pregnancies among the nation's "poorest women is four times that of the middle class." Nonetheless, last year, when Obama proposed the "extension of contraceptive services to women in the hospital giving birth at government expense," Republicans "succeeded in using the term 'family planning' to send coded messages to their base," and the proposal was dropped from the economic stimulus package. To ensure "women's issues are taken seriously," Cahn and Carbone suggest that "[e]very time a member of Congress says the word 'abortion,' we say, 'Where do you stand on preventing unwanted pregnancies?" They add, "[W]e should make members of Congress vote as often on provisions that would help women's lives as they vote on pointless abortion measures that will not change the outcome of a single pregnancy." They conclude, "Let them either vote for effective birth control or explain, clearly and loudly, that what they really want is pregnancy as the price of intercourse. It is time to talk honestly about sex" (Carbone/Cahn, Huffington Post blogs, 4/9).

~ "What a D.A.'s Actions Reveal About the War on Contraception," Amanda Marcotte, RH Reality Check: "The War on Contraception, which is usually fought undercover for fear that the anti-sex agenda of the anti-choice movement might make them less popular, is going mainstream in the U.S.," according to Marcotte. She notes that a Wisconsin prosecutor has warned teachers that complying with the state's new sex education curriculum could lead to an arrest for contributing to the delinquency of minors. She adds that now "some members of Congress" -- such as Minority Leader John Boehner (D-Ohio) -- "are experimenting with putting forward arguments that assume that contraception funding can be presumed immoral and disgusting." According to Marcotte, "'Protect life' is now an unambiguous euphemism for 'punish female sexuality with forced childbirth.'" She writes that during the health reform debate, Boehner contended "that use of contraception, ... is so controversial that an entire health care bill should be repealed to curtail the behavior." Marcotte adds, "This is an assault on the rights of women of all ages to have sex for pleasure without fear of pregnancy, except for those who are wealthy enough to pay for family planning services out of pocket" (Marcotte, RH Reality Check, 4/13).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2010 The Advisory Board Company. All rights reserved.

Advocates Press Obama To Shift Global Policies Away From Bush's Religion-Based Approach

Socially progressive advocacy groups are calling for President Obama's administration to change the nation's approach to global reproductive health and women's rights efforts, including through the restoration of family-planning funding for the United Nations Population Fund, the Washington Post reports. According to the Post, the efforts are part of a push to "transform the way the United States deals with matters of sex, marriage and religious values in the international arena." Congress plans to submit legislation to Obama by March that would restore tens of millions of dollars to UNFPA for family-planning programs for the first time in seven years. In addition, Rep. Carolyn Maloney (D-N.Y.) and Sen. Barbara Boxer (D-Calif.) have pressured the Obama administration to support U.N. conventions to expand rights for women and children. Susan Rice, Obama's nominee for U.N. ambassador, during her Senate confirmation hearing last week said that she also supports the 1979 U.N. Convention on the Elimination of All Forms of Discrimination Against Women. In addition, Secretary of State-designate Hillary Rodham Clinton has said she plans to increase U.S. support for women's rights "in every country, every region on every continent."

The Post reports that Obama's first week in office will coincide with the anniversary of Roe v. Wade, which past presidents have used as an occasion to impose or remove restrictions on funding for groups that provide abortions in other countries. Adrienne Germain, president of the International Women's Health Coalition, said that she hopes the Obama administration will renew leadership on a platform established during the 1994 U.N. Cairo Conference on Population and Development, which emphasized the legitimacy of different types of families and established a basis for women's reproductive health rights, and work toward the goal of universal access to reproductive health services in the next five years. Germain said that during the Bush administration, the "American people have been stifled by the loud and well-organized views of a minority, legitimized by the White House. This is a restoration of the majority view, which is that most people want to see the separation of church and state." Joseph Amon, head of the HIV/AIDS and Human Rights Program at Human Rights Watch, said that although Bush had supported significant investment in global efforts against HIV/AIDS, the efforts relied too heavily on abstinence-based programs. Amon said, "If we want to have an impact on the AIDS epidemic, we cannot allow moral ideological consideration to trump scientific evidence and human rights." Alan Leshner, CEO of the American Association for the Advancement of Science, said that he expects that "there is going to be a reversal in the way in which we approach science-based issues" under the Obama administration, adding that "[s]cience will replace ideology and political expediency as the basis from which you start."














The Post reports that social conservatives -- who under the Bush administration "enjoyed direct access to the White House and to American negotiators in U.N. debates" -- now are "bracing for a long period in the political wilderness." Conservatives plan to refocus attention toward alliances with other conservatives, such as the Vatican, traditionally Catholic countries and Islamic nations. Patrick Fagan, director of the Center for Family and Religion at the Family Research Council, said he predicts a "tectonic shift" in global social policies under Obama's administration (Lynch, Washington Post, 1/18).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

Women Rank GPs Top For Advice On Contraception, But Dept Of Health Funded Report Calls For Further Action, UK

Nearly 60% of UK women rank GPs as their first port of call for information and advice on contraception, according to results of a survey among UK women and their own GPs.1


Around half of pregnancies in the UK are unplanned despite over three quarters of women under 50 using some form of contraception.2,3 Educating women about contraception and the choices available is important so they can make an informed decision about the right method for them and avoid unplanned pregnancy. More than half of women surveyed originally chose their current method because their GP recommended it.1


There are 14 methods available in the UK but the most commonly used is still 'the Pill', used by nearly half of women despite the second most common reason for women using emergency contraception is because they have missed or forgotten to take their oral contraceptive.3,4 A recent Department of Health funded report evaluated the impact of the 2001 National Strategy for Sexual Health and found that progress has been made in many areas but recommended greater access to contraceptive services and that a wider range of methods are offered.5


Dr Anne Szarewski, Associate Specialist in Family Planning at The Margaret Pyke Centre and Talk Choice Panel member, said "GPs and other healthcare professionals play a key role in promoting contraceptive choice and ensuring women understand the method they are considering using. Women are relying on healthcare professionals to help them choose the best method to suit their lifestyle at that time, and therefore avoid unplanned pregnancy. By being equipped with up-to-date information, healthcare professionals can ensure they are providing the best possible information."


Implementing NICE Guidelines


Provision of information and contraceptive choice is recommended in the NICE Guidelines on long-acting reversible contraception methods (LARCs).6 These state that women requiring contraception should be given information about and a choice of all contraceptive methods, including LARC methods such as the implant, injection, IUD (intrauterine device) and IUS (intrauterine system). While a third of GPs in the survey were unaware of the guidelines, over three quarters of practices have LARC trained staff.1


While it may be difficult to talk about all 14 methods of contraception during a consultation, it is worth encouraging women to prepare in advance. Talk Choice, the national campaign all about contraceptive choice, provides information and materials to support healthcare professionals in helping women make more informed decisions in the short time available.


For more information on contraceptive choice and a useful guide to give to women, visit talkchoice


Talk Choice


Talk Choice is the national campaign all about contraceptive choice, developed by healthcare company Organon, a part of Schering-Plough Corporation. It aims to inform and educate women about the full range of contraceptive options available to them. Our aim is that, along with their healthcare professionals, women are able to choose a suitable method that works with their body and lifestyle. Organon, a part of Schering-Plough Corporation supports a woman's right to choose her contraception from the full range of options available.
















Talk Choice has a Panel of UK experts


Dr Anne Szarewski - Associate Specialist in Family Planning at The Margaret Pyke Centre

Dr Diana Mansour - Consultant in Community Gynaecology and Reproductive Health Care

Dr Sarah Brewer - Health writer and broadcaster

Toni Belfield - Specialist in Sexual Health Information

Catharine Parker-Littler - Consultant Midwife and founder of midwivesonline

Talk Choice is commissioned and funded by Organon, a part of Schering-Plough Corporation.



Latest updates on contraception in the UK


The National Institute for Health and Clinical Excellence (NICE) Clinical Guideline 30 on long-acting reversible contraception (LARC) was first published in October 2005 and states that women requiring contraception should be given information about and a choice of all contraceptive methods, including LARC. It is due to be updated in 2009.6


In February 2008, the Government announced a ??26.8 million drive to reduce teenage pregnancies and promote the full range of contraception to women of all ages.7


At the 2008 British Pregnancy Advisory Service (BPAS) conference, US contraception expert Professor James Trussell called for increased use of LARCs, suggesting these methods are more effective as they can be 'fitted and forgotten'. Resulting coverage saw 'the Pill' labelled as 'outdated' and 'ineffective', as a result of the number of unwanted pregnancies and abortions due to incorrect use.8


In July 2008 a report by the Medical Foundation for Aids and Sexual Health for the Independent Advisory Group on Sexual Health, funded by the Department of Health, evaluating the impact of the National Strategy for Sexual Health published in 2001 found that there has been progress in many areas but recommend greater access to contraceptive services and that a wider range of methods are offered.5


The NHS Contraception Survey in England 06/07 was released in October 2007 and captures UK use of contraception and attendance at contraception clinics. The Survey for 07/08 is due to be published in October 2008.4


Spoilt for Choice Research


A total of 100 paired interviews involving UK women and their own GPs were completed in June 2008. The fieldwork was led by Gillian Kenny Associates Ltd, a UK medical market research field agency.


Organon, a part of Schering Plough Corporation


Organon is now a part of Schering-Plough Corporation. Schering-Plough is an innovation-driven, science-centred global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and the UK web site is schering-plough.


References


1. Spoilt for Choice: contraception conversations between women and their own GPs. Fieldwork by Gillian Kenny Associates Ltd. Commissioned and funded by Organon, a part of Schering-Plough Corporation and Virgo HEALTH. June 2008.


2. Kishen M et al. Contraception in crisis. J. Fam Planning Reprod Health Care. 2006:32(4).


3. Ladar D. Contraception and Sexual Health 2006/7. Newport, UK: Office for National Statistics. 2006/07.


4. NHS Contraceptive Services in England report 2006-07. October 2007. Available from: ic.nhs/statistics-and-data-collections/health-and-lifestyles/contraception (Last accessed 19 August 2008).


5. Medical Foundation for AIDS & Sexual Health (MedFASH). Progress and priorities - working together for high quality sexual health: Review of the National Strategy for Sexual Health and HIV. Produced for the Independent Advisory Group on Sexual Health and HIV. July 2008. Available from: medfash/publications/documents/Recommended_standards_for_sexual_health_services.pdf (Last accessed 19 August 2008).


6. NICE Clinical Guideline 30. Long-acting reversible contraception (LARC). October 2005.NHS


7. Department of Health. ??26.8 million to improve access to contraception. February 2008.


8. Trussell J. Why contraception fails. Office of Population Research, Princeton University. Presented at the British Pregnancy Advisory Service (BPAS) conference. June 2008.


Source

Porazinski

Account Executive

Virgo HEALTH

1 Indigo House, Holbrooke Place, Richmond, TW10 6UD

virgohealth

India's NACO To Distribute 1.5M Female Condoms To Sex Workers In Four States

Approximately 1.5 million female condoms will be distributed and marketed to commercial sex workers in four Indian states this year in an attempt to provide women with a method of HIV prevention, IANS/Hindustan Times reports. Sujatha Rao, director-general of the National AIDS Control Organisation, said that female condoms were introduced to commercial sex workers through a 2007 pilot program and that the program will be expanded because of its high success rate. Rao added that the female condom is still a new product and that "demand for it has to be generated." NACO will focus the program on Andhra Pradesh, Maharashtra, Tamil Nadu and West Bengal. The condoms will be promoted through a social marketing campaign with NACO's 200 partner nongovernmental organizations that run targeted intervention sites for commercial sex workers.

According to IANS/Times, the female condoms will be manufactured for the Indian market by Hindustan Latex through a technology transfer from the Female Health Company, which produces female condoms used worldwide. Kavitha Potturi of HLFPPT, the non-for-profit wing of Hindustan Latex, said that the four states will have "100% coverage" and that the product is "expected to benefit a population of 200,000 sex workers." According to FHC, cost has been the largest barrier to making female condoms widely available to women at risk of HIV. In addition, the company said that by manufacturing the female condoms in India, the cost per condom will decrease from 45 rupees, or about $1, to 23 rupees, or about 51 cents. Commercial sex workers will be able to buy the female condoms for three rupees, or about 6 cents, under the program, compared with the five rupees, or about 11 cents, needed to buy female condoms last year (Thapar, IANS/Hindustan Times, 9/9).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Variations In Treating Heavy Menstrual Bleeding Found

The Office for Research and Clinical Audit (ORCA) at the Royal College of Obstetricians and Gynaecologists (RCOG) has published the results of a study into the treatment of women with heavy menstrual bleeding in England. The study found that the use of surgery was four-times greater in some regions compared to other parts of England.


The study used routinely-collected hospital data to investigate the care of 51,456 women who had surgery for heavy menstrual bleeding. Overall, 4 in 10 had a hysterectomy. However, there was also regional variation in the type of surgery performed, with the proportion of women having a hysterectomy ranging from 25% to 54%.


In England, around one in 20 women aged 30 to 49 years see their GPs each year because of heavy menstrual bleeding. There is a range of effective treatments and the National Institute for Health and Clinical Excellence (NICE) recommends that women are provided with evidence-based information about their treatment options prior to considering irreversible operations such as hysterectomy. The variation in the use of surgery suggests this information is lacking. The RCOG, in partnership with the London School of Hygiene and Tropical Medicine (LSHTM) and Ipsos-Mori, will soon begin a national audit into the hospital-based treatment of heavy menstrual bleeding. One aim of the audit is to provide better information about treatment options.


Dr Tahir Mahmood, RCOG Vice President of Standards, said "This research shows how current NICE guidelines may not always be followed. Why this is the case has been the object of some speculation but we have good evidence now of the substantial variation in surgical treatment across the regions.


"There is a move to more conservative treatment, where appropriate, but this research has highlighted the important role of information provision in gynaecological surgery. Women need to be informed of the risks and benefits of each surgical option before decisions are made."


The research is published in the September 2009 edition of BJOG: An International Journal of Obstetrics and Gynaecology.


Notes


The Office for Research and Clinical Audit (ORCA) is a collaboration between the Royal College of Obstetricians and Gynaecologists (RCOG) and the London School of Hygiene and Tropical Medicine (LSTMH) lshtm.ac/ .


Heavy menstrual bleeding is defined as excessive menstrual blood loss, which interferes with the woman's physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms.


A hysterectomy is defined as surgery to remove the womb. This operation occurs when a woman is suffering from heavy periods, fibroids or some gynaecological cancers.


Data for the study was extracted from Hospital Episode Statistics (HES), the database that holds information on all admissions to NHS hospitals in England. The study covered women aged between 25 and 59 years at the time of their first surgery for heavy menstrual bleeding, included procedures performed between 1 April 2003 and 31 March 2006.


In this study, researchers found substantial variation in surgical rates among PCTs. There was less variation in the rates of PCTs within the same SHA. PCTs in London were noted to have had lower surgical rates. There was also considerable variation in the surgical techniques used. The proportion of women who underwent endometrial ablation ranged from 46% to 75% between the SHAs. Among the PCTs, the use of the procedures was even more varied for endometrial ablation, the range being from 16% to 92%. Rates of surgery were found to be higher in PCTs with greater deprivation and in PCTs where a greater proportion of endometrial ablations were performed. Surgery rates were lower in SHAs which had more consultants.


The NICE guidance on the treatment of heavy menstrual bleeding was published in 2007 and is available at nice/


Reference


"Surgery for menorrhagia within English regions: variation in rates of endometrial ablation and hysterectomy."
Cromwell D, Mahmood T, Templeton A, van der Meulen J.
BJOG 2009;116:1373-1379


Source
Royal College of Obstetricians and Gynaecologists

Cleveland Clinic Medical Guide Helps Women Face Midlife

Cleveland Clinic Press has just released "Women's Health: Your Body, Your Hormones, Your Choices," a medical guide women's health pioneer Holly L. Thacker, M.D., founder and head of the Cleveland Clinic Women's Health Center . Her book offers practical advice to help women successfully move through the changes of their middle years and beyond.


Dr. Thacker's medical book covers a broad range of topics, including menopause symptom control, bone-health basics, midlife sexuality, skin health, heart health, and prevention of cancer and other diseases. She provides a wealth of information on how women can improve their vitality, longevity, and quality of life.


"There's so much confusing and contradictory information in the news these days regarding women's health, perpetuating uncertainty among women facing midlife," Dr. Thacker says. "By providing answers to commonly asked questions and clearing up medical misconceptions surrounding women's health, I hope to empower women to make better-informed health-care choices."


Women's Health gives guidance on nutritious eating to promote a healthy midlife. It outlines the risks and benefits of hormone therapy, and discusses customizing hormone therapy for individual needs. Dr. Thacker's health book also contains quick tips on issues ranging from preventive care to breast-imaging options and the benefits of acupuncture.


Purchase "Women's Health: Your Body, Your Hormones, Your Choices" and other Cleveland Clinic Press books on health at clevelandclinicpress/index.php?s=6.


About Cleveland Clinic Press


Cleveland Clinic Press is a medical book publisher whose mission is to improve health literacy and dispel myths associated with health and health care. The Press offers leading medical guides and health books, including nutrition books, cancer books, healthy cookbooks, kids' books on health, and more. View all medical books at clevelandclinicpress.


About Cleveland Clinic


Founded in Cleveland, Ohio, in 1921, Cleveland Clinic is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey.


Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2005, there were 2.9 million outpatient visits and nearly 54,000 hospital admissions to Cleveland Clinic. Patients come for treatment from every state and from more than 80 countries.


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Nation's Ob-Gyns To Meet In Washington For 59th Annual Clinical Meeting

Obstetrician-gynecologists from across the US and around the world will convene April 30-May 4 at The American College of Obstetricians and Gynecologists' 59th Annual Clinical Meeting (ACM) in Washington, DC, at The Walter E. Washington Convention Center. The preliminary program is available online.


The ACM is one of the largest gatherings of ob-gyns in the US. The meeting, attended by thousands of experts in the field, will host scientific plenary sessions, symposia, postgraduate courses, new research posters, paper presentations, and current issue updates. Controversies in ob-gyn, new STD screening and treatment recommendations, and advancements in gynecologic treatments are among the many topics on the agenda at this year's meeting.


Some conference highlights include:


Monday, May 2


1st Plenary Session-President's Program

8:45-10:30 am

Samuel A. Cosgrove Memorial Lecture

Moderator: Richard N. Waldman, MD, ACOG President


Exceptional Opportunities in Biomedical Research

Francis S. Collins, MD, Bethesda, MD

Subclinical Intrauterine Infection/Inflammation as a Cause of Preterm Labor and Cerebral Palsy

Roberto J. Romero, MD, Detroit, MI, and Bethesda, MD

Misogyny and Women's Health

David A. Grimes, MD, Chapel Hill, NC


Clinical Seminars

10:45 am-Noon

Contraception for Adolescents and Young Women

Melissa L. Gilliam, MD, Chicago, IL; Amy K. Whitaker, MD, Chicago, IL


New STD Recommendations

Bernard Gonik, MD, Detroit, MI; Linda O. Eckert, MD, Seattle, WA


2:30-4 pm

The Great Mimic of Presumed Gynecologic Pelvic Pain-Interstitial Cystitis and Myofascial Pain

Mary T. McLennan, MD, St. Louis, MO; Fah Che Leong, MD, St. Louis, MO


Managing Infertility Without IVF: The Old Fashioned Way

Michael F. Thomure, MD, St. Louis, MO


4th Plenary Session-The March of Dimes Lecture

3:45-4:45 pm

VBAC or ERCD? Risks vs. Benefits to Mother and Infant

F. Gary Cunningham, MD, Dallas, TX


Tuesday, May 3


Symposia

11:15 am-12:30 pm

7th Symposium-Donald F. Richardson Lecture

Moving Forward: Pregnancy in Women with Physical Disabilities

Caroline C. Signore, MD, Bethesda, MD
1:30-3 pm

8th Symposium-Howard Taylor International Symposium

Maternal Mortality

Moderator: Sir Sabaratnam Arulkumaran


Maternal Mortality in the USA

Jeffrey C. King, MD, Louisville, KY

Saving Mothers Lives in the UK-The Impact of the UK Confidential Enquiries into Maternal Deaths
and Near Miss Reviews

Professor Gwyneth Lewis, London, England


Clinical Seminars

2:30-4 pm

Inherited Breast and Gynecologic Cancer: What You Need to Know in 2011

Noah D. Kauff, MD, New York, NY


Wednesday, May 3


Symposia

11th Symposium-The John and Marney Mathers Lecture

Fertility Preservation Before Chemotherapy
Teresa K. Woodruff, PhD, Chicago, IL


Source:

American College of Obstetricians and Gynecologists

Cervarix® Data Show That Higher Levels Of Antibodies In The Bloodstream Correlate To Higher Levels In Cervico-vaginal Secretions

New data in women 15 to 55 years of age show that the GlaxoSmithKline (GSK) cervical cancer candidate vaccine induces an immune response to cancer-causing human papillomavirus types 16 and 18 in the bloodstream which highly correlates to antibody levels in the cervico-vaginal secretions. Furthermore, these antibodies to cancer-causing virus types 16 and 18 were detected and sustained for one year following completion of the vaccination course. These data were presented Tuesday at the AmericanCollegeof Obstetrics and Gynecology (ACOG) annual meeting.


"Cancer-causing human papillomavirus is very effective at hiding from the immune system because it exists within the cervical epithelium, away from the bloodstream," said Prof. Dr. Tino F. Schwarz, Stiftung Juliusspital Wuerzburg, Germany, the lead study investigator. "This emphasizes the need for a cervical cancer vaccine to be effective in the cervix, at the site of infection. These data show there is a correlation between the vaccine inducing high antibody levels to the cancer-causing virus types in the bloodstream and the presence of antibodies in cervico-vaginal secretions, potentially providing antibodies where they are needed most."


This study is a subset of data from 90 women participating in a larger, open, age-stratified trial of 666 women between 15 to 55 years of age. Blood samples were collected at several time points after the first vaccine dose, and cervico-vaginal secretions were collected at 18 months. Samples were measured for immune response against cancer-causing virus types 16 and 18. Results from the study show that antibodies to cancer-causing virus types 16 and 18 in the cervico-vaginal secretions were detected across all age groups.


The results also show that antibody levels in the bloodstream were in the same range as those seen in a separate efficacy study of females 15 to 25 years of age, which indicate that the GSK cervical cancer candidate vaccine has shown to provide in the trials a 100 percent efficacy for 5.5 years in preventing precancerous lesions due to cancer-causing virus types 16 and 18.


"These results are exciting, as they confirm that the higher the antibody levels in the blood, the higher the levels in the cervico-vaginal secretions, and present at the site of infection, where they are needed most," said James Tursi, M.D., Director of Medical Affairs, North Americaat GlaxoSmithKline. "These data are critical in helping us to better understand how our cervical cancer candidate vaccine formulated with the novel adjuvant, AS04, helps provide protection against cancer-causing virus types."


About Cervical Cancer


After breast cancer, cervical cancer is the leading cause of cancer-related death in women between the ages of 20 to 39 in the United States. The American Cancer Society estimates that in 2007 more than 11,000 women will be diagnosed with cervical cancer and nearly 4,000 will die from this disease in the United States. Furthermore, approximately 2 million precancerous lesions are diagnosed each year in the United States.















About The GSK Cervical Cancer Candidate Vaccine


GSK submitted aBiologics License Application for CERVARIX® with the U.S. Food and Drug Administration in March 2007. In addition, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and numerous countries in Asiaand Latin America.


About GlaxoSmithKline


GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit gsk/media.


GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world ??" an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatricvaccines which protect the world's children with up to six diseases in one vaccine.


Cautionary statement regarding forward-looking statements


Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.


GlaxoSmithKline

gsk


View drug information on Cervarix [Human Papillomavirus Bivalent.

New Research Could Help Women Facing High Risk Of Stillbirth

The risk of stillbirth is particularly high for women with Type 1 or Type 2 diabetes who suffer four times as many stillbirths as non-diabetic women. The tools currently available to monitor such risks are limited and give results only at late stages of pregnancy. Now research by Warwick Medical School at the University of Warwick is identifying new methods of early & accurate monitoring of the risks faced by such women.


The new research by a Warwick Medical School team, Dr Harpal Randeva, Dr Paul O'Hare & Dr Dimitris Grammatopoulos; Consultant Endocrinologists and Mr Manu Vatish, Consultant Obstetrician, focussed on the profound alterations in the hormonal metabolism of pregnant women and the metabolic signals between mother and fetus. They particularly looked at a key signalling molecule, mainly produced by fat cells, called adiponectin. This is known to have anti-diabetic properties as well as anti-inflammatory and anti-atherogenic actions (it prevents blood clotting which can block arteries). They also closely examined levels of leptin which plays an important role in regulating energy balance and rises during pregnancy.


Given the high perinatal mortality associated with Type 1 diabetes, the researchers investigated adiponectin and leptin levels during both normal and Type 1 diabetic pregnancies. They measured both groups at 20 and 30 weeks into the pregnancy, and after giving birth.


Their novel observations showed that adiponectin levels were higher in pregnant women with type 1 diabetes at all stages of the study compared with the non-diabetic patients. Leptin levels were not different. Furthermore, they have identified adiponectin receptors on the human placenta and detected that the placenta also produces adiponectin. The researchers believe that the fetus produces adiponectin to protect itself from an adverse environment.


This is of vital importance since altered adiponectin levels could now be used to help give effective and early monitoring of the risks faced by women with type 1 diabetes and identify babies who are at risk.


The researchers are now looking for support to extend their studies to develop biological markers for at risk pregnancies. They particularly wish to extend their studies to examine pregnant women with type 2 diabetes and also to pregnant women who are obese (since recent data from the British Journal of Obstetrics & Gynaecology suggests that obese women are at double the risk of stillbirth). The researchers are looking for support to conduct this research and to develop biological markers for at risk pregnancies.


About THE WARWICK OF UNIVERSITY


The University of Warwick is consistently ranked in the Top Ten UK Universities.


WARWICK UNIVERSITY

Coventry

warwick.ac

Researchers Report No Difference In Breast Cancer Characteristics After Oophorectomy

More than half a million women in the United States undergo a hysterectomy each year and approximately half of those surgeries include removal of the ovaries. Researchers know that removing a woman's ovaries is associated with a reduction in the risk of developing breast cancer, but it has not been clear whether those cancers that do arise in these women differ from breast cancers in the general population. Now, investigators at Fox Chase Cancer Center report that women who have had a bilateral oophorectomy tend to have smaller tumors and to have their tumors detected by mammography rather than by physical exam. The use of hormone therapy after surgery, however, wipes out any difference in tumor size or detection method.



The investigators, led by James R. Nitzkorski, M.D., a surgical oncology fellow at Fox Chase, will present their results at the 46th Annual Meeting of the American Society of Clinical Oncology on Saturday, June 5.



"It is helpful to know that tumors that develop after bilateral oophorectomy are not necessarily a more aggressive type of disease," Nitzkorski says. "There was no difference in overall survival or in prognostic factors, such as estrogen receptor status, progesterone receptor status, or HER2/neu status between women who had had an oophorectomy or not."



Removal of a woman's ovaries is associated with an 11% decrease in lifetime risk of breast cancer (the risk reduction associated with the surgery climbs to about 50% in women with a BRCA1/2 mutation). Given that reduction in risk, Nitzkorski and colleagues initially hypothesized that the tumors that do develop in women after a bilateral oophorectomy might be worse than the tumors that arise in the general population because they had to overcome the protective environment that exists in the absence of ovaries - that was not the case.



"I think women can be counseled that although they have developed breast cancer in the protective environment of an oophorectomy, we don't expect their cancer will be any better or worse than that of a woman who didn't have an oophorectomy," Nitzkorski says.



To evaluate the impact of ovary removal on breast cancers, the team identified 687 women diagnosed with invasive breast cancer between 2004 and 2008 at Fox Chase and who had a known ovary status. Of these, 71 (10.3%) had undergone a prior bilateral oophorectomy. The women who had had their ovaries removed were significantly more likely to have taken hormone replacement therapy than women who still had their ovaries, 56.3% versus 19.0%.



Tumors in the women who had undergone a bilateral oophorectomy were smaller than those in women who had their ovaries, with a median of 1.3 cm compared with 1.5 cm, which was a statistically significant difference. Additionally, mammographic detection was more common in women who had had their ovaries removed than in women with their ovaries, 69.0% compared with 47.9%, respectively. Although patient's cancer tumor and lymph node staging was accounted for, Nitzkorski and colleagues have not seen any difference in overall survival related to oophorectomy with in their 20 months of follow up



Abstract #: 1596

Presentation Title: "Characteristics and behavior of invasive breast cancer developed despite prior oophorectomy"

Presentation Time: Saturday, June 5, at 8:00 a.m.



Source:

Diana Quattrone

Fox Chase Cancer Center

Red Meat Linked To Breast Cancer

Eating red meat increases a woman's chance of developing breast cancer, according to new research from the University of Leeds.


The findings are most striking for post-menopausal women those with the highest intake of red meat, the equivalent to one portion a day (more than 57 grams) - run a 56 per cent greater risk of breast cancer than those who eat none. Women who eat the most processed meat, such as bacon, sausages, ham or pies, run a 64 per cent greater risk of breast cancer than those who eat none.


Researchers at the University's Centre for Epidemiology and Biostatistics have been tracking the eating habits and health of more than 35,000 women for the past seven years, and their latest findings are published in the British Journal of Cancer. Earlier findings, widely reported in January, showed that pre-menopausal women who have the greatest intake of fibre have cut their risk of breast cancer in half.


LEEDS UNIVERSITY

Leeds

LS2 9JT

leeds.ac

Noninvasive Test Accurately Identifies Benign Vs. Malignant Pelvic Lymph Nodes In Women With Gynecologic Malignancies

Diffusion weighted MR can accurately identify benign from malignant pelvic lymph nodes in patients with gynecologic malignancy, according to a study performed at Massachusetts General Hospital in Boston, MA. Diffusion weighted imaging is a noninvasive test that uses an MRI sequence sensitized to the motion of water molecules within tissue.


"Conventional imaging with CT or MRI uses the size of a lymph node to determine whether it is malignant. Unfortunately, lymph node assessment by size criteria and morphology is not very accurate in detecting metastasis," said Michael Chew, MD, lead author of the study. This study included pelvic MRI and DWI results of 40 patients with gynecological malignancy. "Our study suggests that DWI can predict lymph node involvement by a tumor with a sensitivity of 92%, specificity of 85% and accuracy of 87%. It has a negative predictive value of 97%, so when DWI determines that a node is not involved by a tumor, it is almost always correct," he said.


"The choice of correct treatment for patients with gynecological malignancy is often determined by whether the cancer has spread to the nodes. DWI can help to depict gynecologic malignancy more clearly and provide useful information regarding lymph node metastasis so that patients are directed to the appropriate treatment," said Dr. Chew.


"It is noninvasive, safe and does not involve radiation exposure or the injection of contrast agents. It is a simple method for defining both primary neoplasm and lymph node spread, helping the oncologist decide between surgery and chemoradiation, or to define the extent of surgery that needs to be performed. It also aids in assessing prognosis," he said.


"Our results are based on a small series of patients at a single institution. The next step is to carry out larger studies that include more patients and institutions. The long-term goal is to improve the care of cancer patients by developing more accurate imaging," said Dr. Chew.


This study will be presented at the 2009 ARRS Annual Meeting in Boston, MA, on Tuesday, April 28.


About ARRS


The American Roentgen Ray Society (ARRS) was founded in 1900 and is the oldest radiology society in the United States. Its monthly journal, the American Journal of Roentgenology, began publication in 1906. Radiologists from all over the world attend the ARRS annual meeting to participate in instructional courses, scientific paper presentations and scientific and commercial exhibits related to the field of radiology. The Society is named after the first Nobel Laureate in Physics, Wilhelm Roentgen, who discovered the x-ray in 1895.


Source: American Roentgen Ray Society (ARRS)

Asian Son Preference Will Have Severe Social Consequences, New Studies Warn

Prenatal son selection in several Asian countries is likely to have severe social consequences in coming years, according to a new series of studies commissioned by UNFPA, the United Nations Population Fund.


Life could become harder for many girls and women outnumbered by males, as pressures to conform and comply increase. A growing number of men will be unable to find wives, which may lead to a rise in sexual violence and trafficking of women.


India and China, with the most dramatic imbalance between births of boys and girls, are stepping up efforts to address the issue. But authors of the reports say more concerted measures to promote gender equality are urgently needed.


Viet Nam and Nepal are poised to endure the same scenario unless action is taken, the research shows clearly for the first time.


The studies on the causes, likely consequences and possible remedies for sex-ratio imbalance in each of the four countries and a regional analysis were presented at the Fourth Asia-Pacific Conference on Reproductive and Sexual Health, which began in Hyderabad today.


Son preference is deeply rooted in many Asian countries, for both cultural and economic reasons. Daughters may be seen as a liability, especially where dowries must be paid. Older parents typically rely on sons, and their wives, for support. And sons may be needed to perform last rites or ancestor worship.


With family sizes falling, Asians have increasingly used ultrasound or amniocentesis to determine the sex of foetuses and aborted unwanted females. The resulting skewed sex ratios at birth (SRBs) have been noticeable in China for over 15 years, rising to 120 males for every 100 females born in 2005 (the natural ratio is around 105 to 100) and as high as 130 in several provinces. In India, the 2001 census revealed that SRB had risen to 108 nationwide, and to 120 in some northern and western states.


Sex ratios among later births are much higher than for firstborn children, reflecting the greater pressure on women to have a son after bearing only daughters. In China, sex selection is more prevalent in rural areas; in India it is more common among better-off urban families.


Up to now, there has been scant research on the likelihood that SRBs will increase in Nepal and Viet Nam, which have social conditions and values similar to those in parts of India and China, respectively. At UNFPA's initiative, research teams organized focus groups and interviewed officials and health providers. In each country, they found pervasive son preference and acceptance of the notion that couples without sons might choose to avoid bearing daughters. They also learned that those who wanted to could easily do so.


The team in southern Nepal, for instance, found that most people knew they could find ultrasound clinics and abortion providers in India willing to flout regulations prohibiting sex selection.















"Viet Nam is in almost the same situation now as China was ten years ago," that country's study concluded, predicting SRB could become seriously imbalanced within a decade.


In the UNFPA-sponsored studies, renowned social scientists analyzed the son selection trends and their implications. French demographer Christophe Guilmoto, author of the India and regional reports, warned that future deficits of adult women will affect "the stability of the entire marriage system". Many men, particularly the poorest, will be unable to marry, creating a pool of potential social unrest and conditions likely to increase sexual violence against women.


The authors also reviewed the most promising approaches being taken to reduce son preference and prenatal sex-selection, which is prohibited in all four countries studied. In India, civil society groups, including medical professionals, have mobilized to raise public awareness. New laws target discriminatory inheritance rules and domestic violence.


A programme in China combines public education with practical steps - such as increasing old-age support - to improve women's status and counter the neglect that leads to a higher mortality for girls than boys. This "Care for Girls" campaign is now being scaled up to the national level.


Comparable initiatives are recommended for Nepal and Viet Nam.


"Sex ratio imbalances only lead to far-reaching imbalances in the society at large," UNFPA Executive Director Thoraya Ahmed Obaid told the Hyderabad conference in a statement delivered by Deputy Executive Director Purnima Mane. "And in response, we must carry forward the message that every human being is born equal in dignity, worth and human rights."


The studies and other related information are available here.



UNFPA, the United Nations Population Fund, is an international development agency that promotes the right of every woman, man and child to enjoy a life of health and equal opportunity. UNFPA supports countries in using population data for policies and programmes to reduce poverty and to ensure that every pregnancy is wanted, every birth is safe, every young person is free of HIV/AIDS, and every girl and woman is treated with dignity and respect.


unfpa