Multivitamin Use Linked To Increased Breast Cancer Risk

Researchers in Sweden who studied data on over 35,000 middle aged and older women followed for 10 years found a link between taking multivitamins and increased
risk of breast cancer and said this was of concern to public health and should be investigated further.


You can read about the study, conducted at the Karolinska Institutet in Stockholm, Sweden, online in the 24 March issue of the American Journal
of Clinical Nutrition.


Many women use multivitamins in the belief that they will protect them from chronic diseases like cancer and heart disease, wrote the authors in their
background information.


In fact, in February 2009, the Archives of Internal Medicine published details of a large US study of over 160,000 postmenopausal women
that found no convincing evidence that long term use of multivitamins changed their risk of developing common cancers, cardiovascular disease or
dying prematurely.


But, as the authors of this Swedish study pointed out, the effect of multivitamins on breast cancer only is unclear.


For the prospective study, lead and corresponding author Dr Susanna C Larsson, of the Division of Nutritional Epidemiology, National Institute of
Environmental Medicine at the Karolinska Institutet, and colleagues, looked at data from 35,329 women in the Swedish Mammography Cohort, who
filled in questionnaires about their use of multivitamins and breast cancer risk factors. The women were cancer free and aged between 49 and 83 when
they filled in the questionnaires in 1997.


The results showed that:

974 women were diagnosed with incident breast cancer over a mean follow up of 9.5 years.

293 of the diagnoses were among 9,017 women who reported using multivitamins.

Use of multivitamins was linked to a statistically significant 19 per cent increased risk of breast cancer (after adjusting for lifestyle and risk
factors like weight, diet, smoking, exercise, and family history of breast cancer, the relative risk of women who reported using multivitamins was 1.19,
with confidence interval ranging from 1.04 to 1.37).

Hormone receptor status did not change the strength of this link significantly.

The authors concluded that:


"These results suggest that multivitamin use is associated with an increased risk of breast cancer. This observed association is of concern and merits
further investigation."


Readers concerned about these findings should note that they don't prove that multivitamins caused the women's breast cancer: a prospective study,
which this was, can only show whether there is a link or not and try and rule out possible influencers.


As Larsson pointed out in an email to Reuters Health, it is possible that something they did not measure is responsible for the link. Also, even if the
link was causal, these findings show that for any one woman, using multivitamins has a small effect on her risk of breast cancer, she noted.


However, given the widespread use of multivitamins, there is an important public health message in this study, said the authors.


Speculating on what the biological reasons might be, the researchers mentioned various previous studies that taken as a whole reveal a conflicting
picture. For example, some studies on folic acid suggested it increases breast cancer risk while others suggested it has no effect and may even decrease
it.


In the meantime, Larsson recommends women eat a healthy and varied diet instead of using pills to get the nutrients they need.


"Multivitamin use and breast cancer incidence in a prospective cohort of Swedish women."

Susanna C Larsson, Agneta ?…kesson, Leif Bergkvist, and Alicja Wolk

Am J Clin Nutr Published online 24 March 2010.

DOI:10.3945/ajcn.2009.28837


Related article:


Multivitamins Don't Change Cancer Or Heart Risk In Postmenopausal
Women


Sources: AJCN, Reuters, MNT Archives.



: Catharine Paddock, PhD

Wine keeps women's hearts beating healthily

Drinking wine, but not beer or spirits, keeps women's hearts beating healthily finds research in Heart.


Much of the research on the potential health benefits of alcohol has been done on men, and it is still not clear exactly why
moderate amounts of wine seems to be good for heart health.


The Swedish research team studied 102 women under the age of 75, all of whom had survived a heart attack or heart surgery for
blocked arteries. All participants were asked to record their alcohol intake for one week after a year.


And after at least a year, a heart tracing (ECG) was taken over 24 hours during routine activities in all the participants,
to test heart rate variability or HRV.


HRV measures the changes in time intervals between the beats of the heart. Decreased variability has been associated with an
increased risk of heart disease and death.


HRV was highest in women who drank 5 or more grams of alcohol a day, equivalent to more than half a standard unit, and lowest
in those who drank no alcohol at all.


But further analysis showed that the type of alcohol consumed was important.


HRV was highest among women who drank wine, even after taking account of other influential factors, such as age, weight, and
smoking habit. Beer and spirits had little impact on HRV.


The favourable effects on HRV may be one of the reasons why wine protects heart health, suggest the authors.


Wine drinking is associated with increased heart rate variability in women with coronary heart disease [Heart 2005; 91:
314-8]


Contacts:

Professor Staffan Ahnve, Department of Preventive Medicine, Karolinska Institute, Stockholm, Sweden.

Tel: +46 8 737 3897; Mobile: +46 70 56 00 062

Email: staffan.ahnvemedhs.ki.se


or
Dr Imri Janszky, Department of Preventive Medicine, Karolinksa Institute

Tel: +46 8 7373 894


Click here to view full paper:

press.psprings/heart/march/314_ht35105.pdf

Health Effects Of Low-Intensity Warfare

For nearly two decades, Ivy Pike, an associate professor of anthropology at the University of Arizona, has been studying ethnic groups in rural northern Kenya to understand how violence shapes the health of those eking out a living there.



The results of her and her colleagues' research," Documenting the health consequences of endemic warfare in three pastoralist communities of northern Kenya: A conceptual framework," is currently published in a special edition of Social Science and Medicine, in collaboration with the British medical journal The Lancet and the Journal of the Danish Medical Association.



These studies also set the stage for Global Response 2010, an international conference on violent conflict and health worldwide. The conference begins Jan. 22 in Copenhagen and is geared for humanitarian workers, physicians, political leaders and academicians working on violence and health.



Pike said their paper offers a "conceptual framework that lays out the importance of methods and approaches to document violence." While considerable research has documented social responses to the ongoing and chronic warfare among groups, there is much less data on how conflict affects community health.



Pike has been studying three nomadic communities - the Pokot, Samburu and Turkana. Like other groups that live in northen Kenya, all are pastoralists, herding cattle, goats, sheep and camels between pasture and water. The region, about the size of Texas, has virtually no infrastructure. Literacy hovers at between 7 and 8 percent.



For hundreds of years, friction between these groups has centered largely on access to scarce grazing and water, and by livestock theft. Persistent drought over the last several years has raised tensions all the more, aggravated further by the introduction of firearms, especially automatic weapons in recent years.



Pike said that households she first studied in the early 1990s that might have had military-issue rifles, by mid-decade all had AK-47s.



"It's easy to treat this violence as cattle rustling, but it's much more complicated, with disparate impacts on people's daily lives and health," Pike said.



"We're documenting nutritional change over time. That's important because families that are nomads are very dependent on their livestock, so any shift in holdings or their animals' access to food and water impacts food security," she said.



While young men are killed or wounded by gunfire in raids, Pike said women and children also bear a considerable load from the violence. "The tendency is to say more young men are dying, but I can't substantiate that at this point. It looks like the fallout for women and children is just as high."



Men generally have better health because they travel with the herds and consequently have better access to meat and milk. Women will sacrifice to feed their children and older women will protect young mothers. All women will forego food when their children are hungry. This makes women an important barometer of health and well-being, especially when their specific group has born the brunt of a violent attack.



Still, there is almost no data on the links between violence and armed conflict to shifts in health. Pike said pursuing this line of research has implications for many of the under-developed and developing regions of the world, especially in sub-Saharan Africa and Asia, where violence has increased dramatically related to displaced populations.



Source: Ivy L. Pike


University of Arizona

Improving The Lives Of Torture Victims From Around The World

The Robert Wood Johnson Foundation (RWJF) has announced its selection of Dr. Uwe Jacobs, clinical and executive director of Survivors International, San Francisco, to receive a Community Health Leaders Award. He is one of 10 extraordinary Americans to receive the RWJF honor for 2009 at a ceremony at the Mayflower Hotel in Washington, D.C.



Jacobs has provided therapeutic care to more than 1,000 individuals who have experienced torture. He is also a leader in efforts to officially recognize and define gender-based violence as torture. "Dr. Jacobs has organized an outstanding interdisciplinary team of individuals from the health professions and the legal profession to help victims of torture to heal and rebuild their lives," said Janice Ford Griffin, national program director for the award. "He is a leader in the effort to expand the legal definition of torture to encompass individuals who have suffered at the hands of non-uniformed actors."



In working with a wide array of people from different nations and backgrounds, and with victims of genocide from around the world, Jacobs realized that a lot of the people who were being persecuted were victims of domestic violence, female genital mutilation, sex trafficking and the threat of honor killings. Seeing the tremendous need, he developed a program to provide services to victims of gender-based violence who seek asylum in the United States. This program has demonstrated that survivors of gender-based violence have levels of trauma that are comparable to those of most torture victims.



"I am deeply honored by this award, and I hope it brings attention to the importance of helping victims of torture to heal," said Jacobs. "I owe a tremendous debt of gratitude to all the lawyers who help these victims obtain asylum so that they can truly begin to rebuild their lives."



Jeffrey S. Kaye, Ph.D., a staff clinician at Survivors International, said that in his opinion, "Dr. Jacobs' greatest contribution - possibly his greatest talent - is his ability to transfer his considerable clinical experience and knowledge to the greater community."



The Community Health Leaders Award honors exceptional men and women from all over the country who overcome significant obstacles to tackle some of the most challenging health and health care problems facing their communities and the nation. The award elevates the work of the leaders by raising awareness of their extraordinary contributions through national visibility, a $125,000 award and networking opportunities. This year the Foundation received 532 nominations from across the United States and selected 10 outstanding individuals who have worked to improve health conditions in their communities with exceptional creativity, courage and commitment.



There are nine other 2009 Community Health Leaders in addition to Jacobs.



Source:
Jennifer Combs


Robert Wood Johnson Foundation Community Health Leaders

Blogs Comment On Emergency Contraception Access, Abortion-Rights Compromises, Other Topics

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

~ "Walgreens Continues Gender Discrimination at the Pharmacy," Lisa Graybill/Brigitte Amiri, American Civil Liberties Union's "Blog of Rights": Grayball, of ACLU of Texas, and Amiri, of ACLU's Reproductive Freedom Project, write that "local Walgreens in Texas have repeatedly refused to sell contraception to men, despite corporate headquarters policy and federal guidelines to the contrary." In a recent case, Adam Drake tried to purchase emergency contraception at a Walgreens in Houston but was told he could not buy the product because he is a man. Although "no one should face gender discrimination at the pharmacy," the Drake case is "even more troubling" because ACLU "had already asked Walgreens earlier this year to ensure that its stores sell [EC] to men" after similar incidents in Mississippi and Texas, according to the blog. In June, Walgreens responded that it had notified all stores that they must sell EC to men. "Apparently, the Walgreens that Mr. Drake went to did not get that message," Graybill and Amiri write. As a result, ACLU has "asked Walgreens to train its pharmacists and store managers and send secret shoppers to its stores to ensure that corporate policy is followed," they add (Graybill/Amiri, "Blogs of Rights," ACLU, 11/17).

~ "Bullying and Post-Abortion Trauma," Feminists for Choice: Recent widely publicized bullying cases -- especially ones directed toward lesbian, gay, bisexual and transgendered individuals -- have prompted many celebrities to "voic[e] their belief that life will get better for those bullied," the blog states. However, "it only gets better if individuals grow stronger against criticism or if society becomes more accepting of differences," it notes. The blog adds, "Bullying does not magically disappear once one gets older as we would like to believe, as evidenced from antiabortion bullying" by protesters outside abortion clinics. "While there are many [protesters who] just want to inform women of their options, there are also those who outright pressure and scare women seeking abortions" in an attempt to make them "believe they have done something inherently wrong that they should regret." The blog notes, "Ironically, antiabortion advocates use the emotions felt by a woman after an abortion to evidence that abortion indeed is wrong, even if they may cause the negative emotions (not the abortion itself)." The blog questions whether the symptoms of so-called post-abortion syndrome -- which abortion-rights opponents claim exists but is not medically recognized -- are actually the result of bullying. Therefore, "we, as individuals of society, need to consider what causes the emotions felt by a woman after abortion," it argues (Feminists for Choice, 11/17).














~ "Fight for Health Care Reform or Lose It," Amanda Marcotte, RH Reality Check: Republicans gained a significant number of House seats in this month's elections, boosting their hope that "by continuing to make health care reform (PL 111-148) a contentious, news-grabbing issue, they can make people even more wary of it," Marcotte writes. According to Marcotte, overturning the health reform law is "a tactic favored strongly by the anti-choice movement." She writes, "Knowing that most Americans favor reproductive rights, ... anti-choicers instead just kick up a lot of dirt and make themselves so annoying that the general public is open to making concessions in exchange for some relief." Marcotte adds, "Basically, it's bullying," and "[a]s anyone who spent time in middle school can attest, sadly, bullying often works" (Marcotte, RH Reality Check, 11/17).

~ "Center for Reproductive Rights Sues FDA for Limiting Access to Emergency Contraception," Kelly Castagnaro, International Women's Health Coalition's "Akimbo": Castagnaro reports that the Center for Reproductive Rights on Wednesday filed "a motion for contempt against" FDA for "failing to follow a 2009 court order that would make emergency contraception available over the counter for women of all ages." She notes that in 2005, CRR sued FDA "for failing to grant over-the-counter status for [EC], and in 2006, the FDA agreed to make EC available without a prescription -- but only to women 18 and over, and only behind the pharmacy counter." The center "then pursued legal action to ensure that EC would truly be available over the counter for all women, including young women," she continues. FDA made EC available over-the-counter to individuals 17 and older but has not considered making it available to younger youth. CRR President Nancy Northup said, "FDA has had ample time, countless opportunities, and overwhelming scientific evidence put before it to make a decision." She noted that President Obama "promised that his administration would reverse the [George W.] Bush policy of politics trumping science. But when it comes to emergency contraception, it’s a new administration playing the same old games" (Castagnaro, "Akimbo," IWHC, 11/16).

~ "Couple Asks Web: Should We Abort?" Tracy Clark-Flory, Salon's "Broadsheet": A Minnesota couple is using their blog, birthornot, to ask "anonymous Internet strangers to vote on whether or not they abort" their 17-week pregnancy, Clark-Flory writes. "Cleary, this screams 'pro-life' Internet prank," she says. The website is "chock full of ultrasound images and updates on their perfectly healthy" fetus, she continues, adding that the couple "say this is a way for Americans to really make their vote matter." Clark-Flory notes that the couple's "Web trail" suggests they are not serious about aborting, as they have indicated support for social conservative figures like Glenn Beck and President George W. Bush. "If this is indeed a prank -- and either way, it's scary to think of these two procreating -- it's a perfect illustration of just how poorly some anti-choicers understand the pro-choice position," Clark-Flory argues, concluding, "The [pro-choice] belief is that the choice of whether or not to abort should be left up to a woman and her doctor, not to the entire Internet" (Clark-Flory, "Broadsheet," Salon, 11/18).

~ "This Won't Work," Scott Lemieux, American Prospect's "Tapped": Lemieux writes that there were "some good points" in William Saletan's recent Slate columns about finding common ground on abortion. "In the abstract, it might be possible to generate a strong consensus by combining a legal regime of legal, safe, accessible abortions with measures dedicated to reducing unwanted pregnancies," Lemieux writes. However, "in the current American political universe, this deal isn't going to happen," as Republicans have "if anything become more hostile to providing adequate support to poor mothers and expanding access to contraception," he continues. "Any analysis [of] American abortion politics that doesn't recognize that the organized opposition to abortion is not just about protecting fetal life but is bundled up with a whole set of reactionary assumptions about gender and sexuality isn't going to get you very far," Lemieux argues. He notes that Saletan's columns also "consist of arguments for more moral hectoring of women." Lemieux adds that "it's hard to see the causal logic where repeatedly criticizing women who have abortions for reasons Saletan considers inadequate is going to increase support for the legal access to abortion that is a central part of the alleged compromise" (Lemieux, "Tapped," American Prospect, 11/18).

~ "Feminist Health Center Closes After Thirty Years, What Does It Mean For Women?" Amie Newman, RH Reality Check: "Feminist women's health centers may be a dying breed," RH Reality Check Managing Editor Newman writes, adding, "Of the over fifty or so operating over the years, only fourteen remain." She asks, "What makes feminist health centers so vulnerable, and what does Planned Parenthood have to do with it (if anything)?" Newman writes that unlike smaller clinics, Planned Parenthood is able to receive government funding because it has the means to separate public money for family planning services from any funding streams for abortion care. By contrast, "feminist health centers are locally grown, small businesses at heart," and they easily "fall prey to a variety of factors, from increased competition from larger-sized providers to a challenging economic environment," according to Newman. She notes that many feminist clinics continue to accept Medicaid patients, despite low reimbursement rates, meaning that they are "literally giving away thousands of dollars in care each year. That's not sustainable without immense support from the public." Feminist Abortion Network President Anita Kuennen has said the closing of a Cedar River Clinics' branch in Yakima, Wash., this week should serve as a "wake-up call to all who support access to choice and access to health care." Newman concludes that if the "closure is a wake-up call, I think we've hit snooze one too many times" (Newman, RH Reality Check, 11/18).


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.


© 2010 National Partnership for Women & Families. All rights reserved.

Breastfeeding More Than Three Months Helps Prevent Obesity In Kids

Breastfeeding longer than three months can cut a child's risk of later becoming overweight or obese by more than 40 percent, if the child was born to an overweight mother diagnosed with diabetes during her pregnancy, according to a study published in the May issue of Diabetes Care.


Researchers in Germany found that the longer a woman breastfed, the less likely her child was to become overweight or obese before the age of 8. The study included 324 children born between 1995-2000 to women with gestational diabetes.


Gestational diabetes refers to a condition that occurs when a woman who has never been diagnosed with diabetes exhibits high blood sugar levels during her pregnancy. This type of diabetes, which affects roughly 4 percent of all pregnant women, goes away after the baby is born but both mother and child are at increased risk for type 2 diabetes later in life.


In the study, more than 37 percent of those children who were never breastfed had become overweight by the age of 8. Of those who were breastfed for up to three months, 32.5 percent became overweight children. But of those who were breastfed longer than three months, only 22 percent became overweight.


The study also found, however, that women who were obese (and whose children were therefore at greater risk for obesity) were less motivated to breastfeed than non-obese women. Obese women were twice as likely to forego breastfeeding their children as women of healthier weights, the researchers noted.


"It's important to find out why these women resist breastfeeding and help them overcome whatever barriers there are," said Dr. Ute Schaefer-Graf, lead researcher on the study. "We know that obesity and overweight contribute to numerous health problems in adults and we are increasingly seeing these problems in children. Since the children of obese parents and, in particular, of women who are diagnosed with gestational diabetes, are at greater risk for gaining excessive amounts of weight as they grow up, breastfeeding becomes more important than ever as a means of getting children started on a path to good health. We strongly anyone diagnosed with gestational diabetes to breastfeed for as many months as possible."


Diabetes Care, published by the American Diabetes Association, is the leading peer-reviewed journal of clinical research into the nation's fifth leading cause of death by disease.


Diabetes is also a leading cause of heart disease and stroke, as well as the leading cause of adult blindness, kidney failure and non-traumatic amputations.


diabetes

FDA Approves Evista To Reduce Invasive Breast Cancer Risk In Postmenopausal Women With Osteoporosis

Evista (raloxifene HCl), a drug aimed at reducing invasive breast cancer risk for both postmenopausal women with osteoporosis and postmenopausal women with a invasive breast cancer risk has been approved by the US Food and Drug Administration (FDA) for both groups of women.


Gwen Krivi, Ph.D., VP, Lilly Research Laboratories "The FDA's decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer. Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."


Evista, which was recently classified as an estrogen agonist/antagonist by the FDA, is a SERM (selective estrogen receptor modulator). It already exists for the prevention/treatment of osteoporosis in postmenopausal women. Two months ago the Oncologic Drugs Advisory Committee (ODAC) voeted for the two new uses to be approved - the FDA, as it did on this occasion, usually goes along with what the committee (advisory panel) recommends.


The decision to approve Evista for this new indication, says makers Eli Lilly, was based on data submitted last year in an NDA (new drug application), which evaluated clinical results from about 37,000 women over a period of ten years; all the women were postmenopausal.


A recent trial found that Evista does not raise the incidence of stroke, but does the incidence of death due to stroke. A boxed warning now says "women with an active or past history of venous thromboembolism should not take EVISTA.. Women at risk for stroke should receive EVISTA only after evaluating the risk-benefit balance with their healthcare providers."


Dr. Lawrence Wickerham, M.D., associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), associate professor of human oncology at Drexel University School of Medicine, said "Thousands of women each year are diagnosed with invasive breast cancer. Today's (14th September) approval of EVISTA for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk."


According to the American Cancer Society, about 180,000 women are diagnosed with invasive breast cancer each year.


-- Important Safety Information About EVISTA®


Important Limitations of Use for Breast Cancer Risk Reduction


EVISTA is indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. EVISTA does not treat existing breast cancer, reduce the risk of getting breast cancer again or reduce the risk of all forms of breast cancer.


evista





View drug information on Evista.

FDA Approves Watson's Generic Version Of Barr's Contraceptive Pill Seasonale; Both Companies To Launch Generic Versions

FDA on Thursday approved Watson Pharmaceuticals' marketing application for its generic version of Barr Laboratories' extended-cycle oral contraceptive Seasonale, Reuters reports. A Barr subsidiary also will launch a generic version, to be sold under the name Jolessa (Reuters, 9/7). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills, compared with the usual regimen of 21 active pills followed by seven placebos. The U.S. Patent and Trademark Office in May denied Barr's request to reissue its patent on Seasonale. Barr's subsidiary Duramed Pharmaceuticals received a nonfinal rejection notice from the patent office, which gave the company three months to reply to issues raised by the government before the company's three-year product exclusivity expired on Sept. 5 (Kaiser Daily Women's Health Policy Report, 5/15). Watson -- which in 2004 filed a marketing application with FDA saying that Duramed's Seasonale patent was unenforceable and void -- announced it will immediately launch its product, which will be sold under the name Quasense, MarketWatch reports. According to MarketWatch, Watson is the first pharmaceutical company to successfully challenge Barr's patent on Seasonale and will have market exclusivity for 180 days (Pritchard, MarketWatch, 9/7).


"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.


View drug information on Seasonale, Lo Seasonale, Seasonique.

Rates In Risk Factor For Breast Cancer, Atypical Ductal Hyperplasia, Fell In Line With Hormone Therapy Decline, US Study

Researchers in the US found that the decline in use of postmenopausal hormone therapy may partly explain the fall in incidence of a known risk factor
for breast cancer, atypical ductal hyperplasia. They also said their findings support the idea that low and high grade breast cancers develop via different pathways and thereby clarify the role that hormone therapy may play in increasing the rates of breast cancer.


The study was the work of first author Dr Tehillah Menes, and colleagues and is published in the November issue of Cancer Epidemiology,
Biomarkers & Prevention, a journal of the American Association for Cancer Research.


Menes, who during the study was the chief of breast service in the Department of Surgery at Elmhurst Hospital Center, New York, told the press
that:


"Postmenopausal hormone treatment is associated with increased rates of benign breast biopsies, and early and late stages of cancer."


"Atypical ductal hyperplasia is associated with the use of postmenopausal hormone treatment and its rates have decreased with the decline in use of
this treatment," she added.


Atypical ductal hyperplasia occurs when abnormal cells start to grow in the milk ducts of the breast and other studies suggest the condition is
linked to a three to five-fold increased risk of developing breast cancer.


For this investigation, Menes and colleagues used data from more than 2.4 million mammography studies with and without breast cancer taken between 1996
and 2005. The data came from the Breast Cancer Surveillance Consortium, which gathers information from a network of seven mammography
registries with links to tumor and/or pathology registries in various parts of the US.


Their aim was to examine risk factors and rates of atypical ductal hyperplasia with and without associated breast cancer over time. They also looked at
tumor characteristics of breast cancer with and without associated atypical ductal hyperplasia in women previously screened with
mammography.


The results showed that:

A total of 2,453,483 screening mammograms were linked to 1,064 biopsies with atypical ductal hyperplasia (ADH), 833 breast cancers with
ADH, and 8,161 cancers with no ADH.

Postmenopausal hormone therapy use decreased significantly from 35 per cent to 11 per cent over the study period.

Rates of ADH decreased from a peak of 5.5 per 10,000 mammograms in 1999 to 2.4 per 10,000 in 2005.

Rates of cancer with ADH decreased from a peak of 4.3 per 10,000 mammograms in 2003 to 3.3 per 10,000 in 2005.

ADH and breast cancer were significantly linked to postmenopausal use of hormone therapy.

Cancer linked with ADH was of lower grade and stage and more estrogen receptor positive than cancer without ADH.

Menes and colleagues concluded that postmenopausal hormone therapy is linked with an increased risk of ADH with or without cancer, and
that:


"Rates of ADH have decreased over the past decade, which may be partially explained by the significant reduction in use of postmenopausal HT
[hormone therapy]."


Co-author Dr Karla Kerlikowske, who is professor of medicine and epidemiology and biostatistics at University of California, San Francisco,
said:


"The rate of atypical hyperplasia declined, which we didn't expect to see with the increased use of mammography to identify abnormal
lesions."


"We did not expect to find a decline in rate of atypical ductal hyperplasia with a decline in postmenopausal hormone treatment use," she
added.


The finding that cancer linked with atypical ductal hyperplasia is usually of lower grade and stage supports the theory that low and high grade cancers
develop via separate pathways, said Menes.


"These findings help clarify the different pathways to the development of breast cancer and the role of postmenopausal hormone treatment in
increasing the rates of breast cancer," she concluded.


Kerlikowske suggested future research should concentrate on the effect of hormone therapy on benign proliferative breast lesions.


"Rates of Atypical Ductal Hyperplasia Have Declined with Less Use of Postmenopausal Hormone Treatment: Findings from the Breast Cancer
Surveillance Consortium."

Tehillah S. Menes, Karla Kerlikowske, Shabnam Jaffer, Deborah Seger, and Diana L. Miglioretti.

Cancer Epidemiol Biomarkers Prev,
November 2009 18:2822-2828

DOI:10.1158/1055-9965.EPI-09-0745


Source: American Association for Cancer Research.



: Catharine Paddock, PhD

Editorials, Opinion Pieces Respond To Executive Order Easing Restrictions On Embryonic Stem Cell Research

Newspapers recently published the following editorials and opinion pieces discussing President Obama's decision on Monday to lift some federal restrictions on embryonic stem cell research.

~ New York Times: Obama's move to ease some of former President George W. Bush's restrictions on embryonic stem cell research "ends a long, bleak period in which moral objections of religious conservatives were allowed to constrain the progress of a medically important science," a Times editorial says. It adds that for other promising stem cell research efforts to receive federal funding, Congress also "must lift a separate ban that it has imposed every year since the mid-1990s." The editorial continues, "With the end of the Bush restrictions, scientists receiving federal money will be able to work with hundreds of stem cell lines that have since been created -- and many more that will be created in the future." However, "[o]ther important embryonic research is still being hobbled by the so-called Dickey-Wicker amendment," which is regularly attached to HHS appropriation bills and prohibits the use of federal funds for research that involves the creation or destruction of embryos, according to the editorial. "Until that changes, scientists who want to create embryos -- and extract stem cells -- matched to patients with specific disease will have to rely on private or state support," the editorial says. It concludes, "Congress should follow Mr. Obama's lead and lift this prohibition so such important work can benefit from an infusion of federal dollars" (New York Times, 3/10).

~ Washington Post: A Washington Post editorial says that Obama did "the right thing" in rescinding some of Bush's restrictions on embryonic stem cell research. However, "this type of experimentation is thick with ethical and moral questions, many of which Mr. Obama put off answering," the editorial adds. According to the editorial, Obama "offered little indication" of how he would enforce guidelines on how embryos would be obtained and used, including if research will be "performed only on stem cell lines grown from the thousands of frozen embryos in fertility clinics that have been slated for destruction." The editorial also asks, "Where does [Obama] stand on growing human embryos for experimentation in general and using them for stem cells in particular?" It concludes, "Some of these ethical questions need to be dealt with in the political arena, and not just by scientists" (Washington Post, 3/10).

~Yuval Levin, Washington Post: Obama's executive order "inadvertently cast a bright light on a dangerous temptation in science policy that ought to give Americans pause," Levin, a fellow at the Ethics and Public Policy Center and executive director of the President's Council on Bioethics from 2003 to 2005, writes in a Post opinion piece. He continues, "[W]hile Obama promised that his policy would be bound by ethical guidelines, he left it to the scientists of the National Institutes of Health to define the rules. The issue, he suggested, is a matter of science, not politics." However, "science policy is not just a matter of science," Levin writes, adding, "Like all policy, it calls for a balancing of priorities and concerns and requires a judgment of needs and values that in a democracy we trust to our elected officials." Levin argues that "to govern the practice of scientific techniques that threaten to violate important moral boundaries is not only legitimate but in some cases essential." According to Levin, the president "argues not for an ethical judgment regarding the moral worth of human embryos but, rather, that no ethical judgment is called for: that it is all a matter of science." He continues that "[t]his is a dangerous misunderstanding," adding, "It is the role of elected policymakers to consider the knowledge that science offers and the power it gives us, and to balance these with other priorities." He concludes, "Science is a glorious thing, but it is no substitute for wisdom, prudence or democracy" (Levin, Washington Post, 3/10).














~USA Today: "Obama's move was a necessary and overdue step to advance research that has the potential to regenerate damaged organs and might one day provide a cure for ... debilitating diseases," according to a USA Today editorial. It adds, "More broadly, it sends an important signal about getting politics out of the laboratory." The editorial continues, "Obama's executive order is not a green light for all research on embryos. Since 1996, Congress has enacted a yearly ban, known as the Dickey-Wicker amendment, on spending tax dollars to create embryos." According to the editorial, "It is up to Congress to decide whether it should be overturned," while the "answer to that question depends on whether existing embryos ... and stem cell lines are sufficient, or whether more are needed to advance research." The editorial notes that "[p]olls show 2-to-1 support for embryonic stem cell research," concluding, "Obama's order doesn't guarantee medical breakthroughs, but it makes them more likely" (USA Today, 3/10).

~ Tony Perkins, USA Today: Instead of "increasing funding for stem cell research that is actually treating patients," Obama has decided to "open federal funding to controversial research that requires the destruction of human embryos," Perkins, president of the Family Research Council, writes in a USA Today opinion piece. According to Perkins, "Since November 2007, Japanese and U.S. scientists have used reprogramming to turn normal cells into embryonic-like stem cells that are identical to embryonic stem cells, without using human embryos or cloning. Researchers call these cells induced pluripotent stem cells, or iPSCs." He writes that "the president has chosen to reignite the waning debate over the use of human embryos," adding, "This is both unwise and unnecessary." Perkins says, "Instead of funding speculative embryo research, the federal government should increase funding for stem cell research that is even now treating patients for dozens of serious conditions." He writes that "Congress should refocus resources on what is working now, by increasing funding for cord blood and other types of adult stem cell research," adding that the "best way to do so" is to approve legislation sponsored by Reps. J. Randy Forbes (R-Va.) and Daniel Lipinski (D-Ill.). "Putting patients first is a strategy we can all embrace," Perkins concludes (Perkins, USA Today, 3/10).



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.

Vigorous Exercise Reduces Breast Cancer Risk In African-American Women

Vigorous exercise of more than two hours per week reduces the risk of developing breast cancer in postmenopausal African-American women by 64 percent, compared to women of the same race who do not exercise, according to researchers at Georgetown Lombardi Comprehensive Cancer Center.


Results were presented at the Third AACR Conference on The Science of Cancer Health Disparities, held Sept. 30 to Oct. 3, 2010.


"People often want to know what they can do to reduce their risk of disease, and we have found that just two or more hours of vigorous activity per week can made a difference in one's risk of developing breast cancer," said the lead researcher Vanessa Sheppard, Ph.D., a cancer control scientist and assistant professor in the department of oncology at the Lombardi Comprehensive Cancer Center.


In this study, more than two hours of aerobics, running or similar activity over the span of a week counted as vigorous activity.


"We also know from other studies that being physically active can have benefits in other diseases that occur at high rates in African-American women, such as diabetes and hypertension," Sheppard said. "Four out of five African-American women are either overweight or obese, and disease control is a particularly important issue for them."


Evidence showing exercise reduces breast cancer risk has been inconsistent, and there are few that look specifically at African-American women, Sheppard said. The issue is important, she added, because breast cancer has some important differences in this community. Whereas more white women are diagnosed with breast cancer, African-American women have a higher risk of developing premenopausal breast cancer than white women do, and comparatively more African-American women develop the most aggressive form of the disease, known as triple-negative breast cancer.


The researchers identified 97 recently diagnosed African-American breast cancer patients in the Washington, D.C., area and matched them with 102 African-American women without breast cancer. Participants filled out a questionnaire about exercise routines; the responses were analyzed and compared.


Women who exercised vigorously for more than two hours a week in the past year had a 64 percent reduced risk of breast cancer compared to women who did not exercise. Women who engaged in moderate exercise, like walking, had a 17 percent reduced risk, compared to women who were sedentary.


After evaluating those who were pre- and postmenopausal, they found that vigorous exercise only significantly benefitted postmenopausal women they had a 62 percent reduction in risk.


"I was surprised that we did not find a significant effect in premenopausal women, but it may be because we need a larger sample," Sheppard said.


However, when the researchers examined the effect of total physical activity, which combined walking with vigorous activity of two or more hours per week, they saw significant gains for both premenopausal and postmenopausal women.


"We suggest that our findings, while promising, should be interpreted with caution. This is a pilot study and a larger, more rigorous study is needed to precisely quantify the effect of exercise on development of breast cancer. I think it is fair to conclude that if African American women exercise they can help take charge of their health," said Sheppard.


Source: American Association for Cancer Research (AACR)

'Artificial Insemination: An Update' - Campus Workshop Announced By ESHRE

The course will cover all aspects of artificial insemination, including health economics and cost-effectiveness, European regulations and reproductive tourism, European IUI monitoring as well as methodological and ethical aspects



Here some of the new research findings that fertility experts from in and outside of Europe will announce:
The evidence of insemination versus intercourse or IVF


Born in the USA! Cost effectiveness of intrauterine insemination versus IVF


Choose your sex - ethical aspects of gender selection


Bank your future. Insemination and semen cryopreservation


Reproductive tourism for insemination due to different regulations


The European tissue directive and IUI


Europe is watching you. European regulations on artificial insemination


ESHRE Capri Guidelines on IUI


* Risk factors for high order multiples births following artificial insemination

Reproductive medicine is one of today's most exciting scientific and clinical areas. Every month brings announcements of research developments, medical 'firsts', new rulings by regulatory bodies, or ethical controversies - often sparking a heated debate among practitioners in the field themselves, as well as ethicists, legislators, the media and the public. ESHRE's activities provide the media with the opportunity to hear the latest research news and interview the experts.



The official language of the course is English. For a detailed program please visit: eshre/page.aspx/723



For this course due to time restrictions you can only register onsite.



Source: Hanna Hanssen


European Society for Human Reproduction and Embryology

Genomic Health Announces Multiple New Findings On Oncotype DX(TM) Based On Evaluation Of More Than 20,000 Tumor Samples

Genomic Health, Inc.
(Nasdaq: GHDX) today announced the results of several studies looking at
the roles and relationships of genes measured by the company's Oncotype DX
breast cancer assay, including an analysis of more than 10,000
node-negative tumors indicating that all 21 genes impact the assessment of
an individual woman's tumor. This research was presented at the 29th Annual
San Antonio Breast Cancer Symposium.



Oncotype DX measures the expression of 16 cancer-related genes plus 5
reference genes of an individual tumor to generate a "Recurrence Score" to
quantify risk of recurrence and likelihood of response to chemotherapy. To
assess the degree to which components of this multi-gene assay influence
the Recurrence Score, researchers measured expression of the 16 individual
cancer genes relative to reference genes in 10,618 tumor specimens on a
scale of 0 to 15, where a one-unit increment is associated with a twofold
change in expression. Results suggest that every cancer gene used in the
Oncotype DX 21-gene panel impacts the Recurrence Score due to the
potentially large variation in quantitative expression for each gene in
different patients. The study found this result even though expression of
certain genes and gene families; including ER, HER2 and a group of five
genes linked to proliferation, have the largest coefficients used in
calculating the Recurrence Score.



"Our ongoing clinical work is generating an abundance of useful and
important data, as evidenced by the collective findings presented in San
Antonio," said Steven Shak, M.D., chief medical officer of Genomic Health.
"With standardized quantitative measurements now analyzed in 20,000-plus
tumor samples, Genomic Health has the unique opportunity to generate and
share knowledge about the biology of breast cancer, which may lead to the
development of more effective individualized treatment for breast cancer
patients."




Study of 20,000 Samples Finds Heterogeneity in Three Breast Cancer
Subtypes



A second study, conducted in the same cohort of 10,618 tumor samples
plus an additional 9,432 samples analyzed recently for a total of 20,050
samples, used RT-PCR analysis as measured by Oncotype DX to identify the
breast cancer subtypes revealed by a standardized quantitative expression
assay. Three major subtypes of breast cancer were identified: patients with
ER-positive and HER2-negative disease; those with HER2-positive disease;
and those negative for ER, HER2 and the progesterone receptor (PR), or
triple negative breast cancer. These three subtypes have been proposed
previously, but the standardized quantitative Oncotype DX test revealed
that there is significant heterogeneity within each subtype that is likely
to be important for individualizing treatment. These results may help
explain why patients with each subtype respond so differently to treatment,
and underscore the importance of standardized measurement of gene
expression as a clinical tool.

















Study of 20,000 Samples Shows Proliferation Genes and Hormone Genes
Provide Independent Assessment




In a third study using the same 20,050 tumor samples, Genomic Health
investigators examined whether genes linked to proliferation were
associated with hormone and growth factor receptors. The hormone receptor
genes, ER and PR, as well as the HER2 growth factor receptor gene, are
well-known markers for disease risk and treatment success; however, the
analysis found that the expression of the proliferation genes was largely
independent of the hormone and growth factor receptor genes. These results
may explain why distinct contributions of multiple genes are required to
characterize the biology and treatment of individual breast cancers.



Kaiser, NSABP Study Finds ER Predictive, PR Prognostic



Separately, Genomic Health, the Pittsburgh-based National Surgical
Adjuvant Breast and Bowel Project (NSABP) and Kaiser Permanente presented
findings from a study that assessed whether PR expression and ER expression
were associated with disease prognosis or were predictive of response to
adjuvant therapy with tamoxifen.



Researchers used Oncotype DX to measure the association between PR and
ER expression and outcomes in more than 1,000 patients from two previously
conducted Kaiser and NSABP studies. In both studies, expression of ER was
associated with how a patient benefits from treatment with tamoxifen, but
was not significantly associated with prognosis in untreated patients,
indicating that it is a predictive factor. In contrast, these findings
showed PR to be a characteristic of disease progression, or prognostic
factor, but not predictive of benefit from tamoxifen. These results
indicate that not all women with estrogen receptor-positive breast cancer
benefit equally from tamoxifen.



"Over the years there have been conflicting reports about the relative
roles of ER and PR as prognostic and/or predictive factors in breast
cancer," said Norman Wolmark, M.D., chairman of the National Surgical
Adjuvant Breast and Bowel Project (NSABP), and the Department of Human
Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania. "Thanks
to these findings, which suggest very distinct roles, we believe we can
better chart how a woman's disease will progress and whether she's likely
to respond to hormone therapy based on her individual quantitative PR and
ER measurements."



About Oncotype DX



Oncotype DX represents the first diagnostic multi-gene expression test
service commercially available that has clinical evidence validating its
ability to predict the likelihood of breast cancer recurrence, the
likelihood of patient survival within 10 years of diagnosis and the
likelihood of chemotherapy benefit. Oncotype DX has been extensively
evaluated in multiple independent studies involving more than 2,600 breast
cancer patients, including a large validation study published in The New
England Journal of Medicine and a chemotherapy benefit study published in
the Journal of Clinical Oncology. For more information about Oncotype DX,
please visit oncotypedx.




About Genomic Health



Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused
on the development and commercialization of genomic-based clinical
laboratory services for cancer that allow physicians and patients to make
individualized treatment decisions. In 2004, Genomic Health launched its
first test service, Oncotype DX(TM), which has been shown to predict the
likelihood of breast cancer recurrence and the likelihood of chemotherapy
benefit in early-stage breast cancer patients. The company was founded in
2000 and is located in Redwood City, California. For more information, please visit genomichealth.



Forward Looking Statements



This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, including
statements relating to the conclusions suggested by research results, the
continued usefulness and importance of data generated by ongoing clinical
work, the potential for Genomic Health to develop more effective
individualized treatments for breast cancer patients, the significance of
various clinical outcomes and possible future uses for Oncotype DX, Genomic
Health's expectations regarding additional studies and expansion of the
clinical utility of Oncotype DX, its potential effect on clinical practice
and treatment decisions for patients, and the applicability of clinical
study results to actual outcomes. Forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially. These risks and uncertainties include the risks set forth in
our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006,
which is on file with the Securities and Exchange Commission and is
available on the SEC's website at sec. These forward-looking
statements speak only as of the date hereof. We disclaim any obligation to
update these forward-looking statements.


Genomic Health, Inc.

genomichealth

N.J. Assembly Passes Bills To Fund Family Planning Clinics, Expand Medicaid Eligibility

The New Jersey Assembly on Monday passed two bills that would restore funding to family planning clinics and expand eligibility for Medicaid coverage of family planning services, the Asbury Park Press reports. The bills now go to the Senate for consideration in early December.

The bills passed along party lines, but neither received the 54 votes needed to override a possible veto by Gov. Chris Christie (R). In June, Christie vetoed similar legislation that would have reversed state budget cuts to family planning clinics, and the Senate failed to override the measure on a party-line vote.

One of the bills (A 3274) would transfer $5 million in reserve funding to state family planning clinics. The measure passed 45-25 with nine abstentions. The bill would prohibit the money from being used to pay for abortion services. Republican critics of the measure argue that the funds would allow family planning clinics that provide abortions to use other sources of revenue for the procedure.

The other bill (A 3273), which passed 44-25 with 10 abstentions, would require New Jersey to apply to the federal government to expand Medicaid coverage for family planning services to people with incomes between 133% and 200% of the federal poverty level, as allowed under the federal health reform law (PL 111-148). Twenty-seven states already have secured federal permission for such expansions. If approved, New Jersey would receive more than $15 million in federal funds over two years by spending $1.1 million in state funds (Symons, Asbury Park Press, 11/22).


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.


© 2010 National Partnership for Women & Families. All rights reserved.

Warner Chilcott Files Suit Against Watson Laboratories Over Application For Generic Version Of Chewable Oral Contraceptive

Warner Chilcott has filed a federal lawsuit against Watson Laboratories in response to Watson's filing of an Abbreviated New Drug Application with FDA to market a generic version of Warner's chewable oral contraceptive Femcon Fe prior to the expiration of Warner's patent in 2019, Dow Jones reports (Derpinghaus, Dow Jones, 10/1). The lawsuit was filed in a U.S. District Court in New Jersey (Warner release, 10/1).

FDA in November 2003 approved the chewable version of Northern Ireland-based Galen Holdings' oral contraceptive Ovcon 35. The chewable pills, which Bristol-Myers Squibb manufactures, contain progestin and estrogen -- the same hormones used in standard birth control pills. Women will be able to chew the pills or swallow them whole; women who chew the pills must drink an eight-ounce glass of water afterward to ensure that the full dose reaches their stomachs. Femcon Fe has similar side effects to other birth control pills, such as an increased risk for blood clots, heart attack and stroke. One month's supply of the pill costs $44 wholesale.

Warner filed a lawsuit against Barr Laboratories in September for its FDA application for its generic version of Femcon Fe. Barr in April filed the FDA application to produce a generic version of the pill, and in August the company received notification of the application's acceptance for filing from the agency. Barr has said it is challenging Chilcott's patent for Femcon Fe, stating that it was the first to file an Abbreviated New Drug Application with FDA. FDA has placed a 30-month stay on action on Barr's application because of the suit (Kaiser Daily Women's Health Policy Report, 9/26). The agency also will place a 30-month stay on Watson's action in response to the lawsuit (Warner release, 10/1).

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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Budget Bill Provision Dropping Requirement For Family Planning Medicaid Coverage Could Increase Unplanned Pregnancies, Sen. Rodham Clinton Says

Senator Hillary Rodham Clinton (D-NY) on Tuesday said the House-approved fiscal year 2006 spending-cut package (S 1932) could increase the number of unplanned pregnancies because it would allow states to discontinue Medicaid coverage of contraception and family planning services, Long Island Newsday reports (Thrush, Long Island Newsday, 12/21). The House on Monday voted 212-206 to approve the $39.7 billion in spending cuts, including $6.4 billion in net savings from Medicare and about $4.8 billion in net savings from Medicaid over five years. States also would be permitted to scale back or eliminate services that currently are guaranteed under federal law (Kaiser Daily Health Policy Report, 12/20). Under current federal Medicaid rules, states are required to offer family planning services (Barrett, AP/Long Island Newsday, 12/20). However, states could "scuttle" those services under the new measure, according to Newsday. "I think this bill may very well increase the number of unintended pregnancies and abortions in our country," Rodham Clinton said (Long Island Newsday, 12/21). She added, "We obviously have very strong opinions and deeply held convictions about abortion, but are we also divided about contraception and family planning? Are we not in this body committed to reducing the number of abortions? Apparently we're not" (AP/Long Island Newsday, 12/20). Republican congressional leaders say the bill aims to give states more flexibility in administering their Medicaid programs, and some experts say states are unlikely to halt family planning and contraception coverage, in part because the federal government pays for 90% of the costs, Newsday reports (Long Island Newsday, 12/21). According to an unnamed staff member for a Senate Republican, state Medicaid plans under the measure would still have to remain equivalent to plans such as the Federal Employees Health Benefits Program or state employee insurance plans, most of which cover family planning services and contraception, CQ HealthBeat reports. The Senate is expected to vote on the bill on Wednesday (Carey, CQ HealthBeat, 12/20).


"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.

Breastfeeding Study Of HIV-Infected Women In Low-Resource Settings: Early Cessation Or Continued Breastfeeding?

A new study by researchers from Columbia University's Mailman School of Public Health addresses one of the most challenging issues in infant health and preventing mother-to-child HIV transmission in poor countries. In these settings, HIV-infected mothers had been advised that for the best outcome for their infants, they should exclusively breast-feed, followed by a rapid weaning four to six months after birth. But according to the study conducted in Lusaka, Zambia by Mailman School researchers, which was published in the July 10 issue of the New England Journal of Medicine, abrupt cessation of breast-feeding by HIV+ mothers after the first four months of life did not result in any statistically significant benefit to infants in terms of HIV-free survival at 24 months, compared to those infants who were weaned at an average of 16 months of age (68.4% versus 64%). A further finding from the study indicated that infants who were HIV+ at four months of age had significantly higher death rates by 24 months if they were abruptly weaned than if breast-feeding were continued (74% versus 55%).



Among infants who were breast- fed and not infected with HIV at four months, there was no statistically significant difference in HIV-free survival at 24 months - 84 percent for those who stopped breast- feeding early compared to 81 percent who continued to breast- feed.



The study included 958 women with HIV and their infants. The proportion of new HIV infections between four and 24 months was not significantly different between the children whose mother abruptly stopped breast-feeding and those whose mothers continued to breast-feed indefinitely, and no significant differences were found in survival between them. Seventy-six percent of infants whose mothers stopped breast-feeding at four months survived to 24 months of age versus 75 percent of infants whose mothers continued breast- feeding for as long as the women chose. Four months was selected as the weaning time because this was the minimum duration of exclusive breast-feeding that was recommended at the time the study was designed.



"We certainly did not anticipate that children who were already infected with HIV before weaning would have significantly worse outcomes if they were to forego breast milk, especially since, theoretically, formula and weaning cereal are nutritionally replete," said Louise Kuhn, PhD, associate professor of Epidemiology at the Mailman School of Public Health and in the Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University. "Our observation of a clear benefit of breast- feeding for HIV-infected children highlights the importance of strengthening infant diagnostic services to triage infected children into HIV care and treatment and to provide encouragement for continued breast-feeding of infected children."



Prior to this latest research it was believed that in many poor countries, mothers with HIV face a stark choice - to nurse their infants, and risk passing on HIV through their breast milk - or to formula feed, and deprive their infants of much of the natural immunity needed to protect against fatal diseases of early infancy. "In the developed world, mothers with HIV forego breast-feeding and formula feed their infants," said Lynne Mofenson, MD, chief of NIH's National Institute of Child Health and Human Development's Pediatric, Adolescent and Maternal AIDS Branch (NICHD), which provided support for the study. "But in many poor countries, there are barriers to formula feeding. Sanitation is lacking, clean water to mix formula is often not available, and many families have difficulty affording infant formula." Formula fed infants also miss out on protective antibodies - passed on through breast milk - needed to ward off the deadly infant diseases prevalent in many parts of the world. Formula feeding, also, may carry a social stigma for mothers and is often seen as acknowledgement that a woman has HIV.
















With these latest findings, the researchers theorize that the chances of transmitting the virus may actually increase as a result of the weaning process. The breast swelling and infection (mastitis) that occurs when breast-feeding is sharply reduced may increase the likelihood that the virus will be transmitted in the few feedings that remain. "These results suggest that early, abrupt cessation of breast-feeding for HIV-infected women in low-resource settings should be avoided," Dr. Kuhn noted.







The National Institutes of Health (NIH) provided support for the study with additional funding by the Centers for Disease Control and Prevention and the United States Agency for International Development. NIH is now sponsoring additional studies to determine the most effective treatments to prevent the spread of HIV through breast milk.



About the Mailman School of Public Health



The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 1000 graduate students in pursuit of masters and doctoral degrees. Its students and more than 300 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. mailmanlumbia.edu/



Source: Stephanie Berger


Columbia University's Mailman School of Public Health

Raloxifene Reduces Breast Cancer Risk In Postmenopausal Women At All Risk Levels

Raloxifene protects postmenopausal women from developing invasive breast cancer whether they are at high or low risk of developing the disease, according to a new study.



The study, published in the September 1 issue of Clinical Cancer Research, also revealed that the drug appears to reduce risk in women with a family history of breast cancer down to a similar level to women without affected relatives.



Compared with a placebo drug, the study found that use of raloxifene was associated with a 58 percent reduction in breast cancer risk in women without a family history of the disease, and an 89 percent reduction in risk for women with a family history of breast cancer.



But the researchers say they cannot explain why protection seems greatest in women who may be genetically predisposed to develop the disease.



"We don't know what to make of this observation," said Marc E. Lippman, M.D., professor in the Department of Internal Medicine at the University of Michigan and the study's lead author. "It could be due to chance, or there may be other factors at work that we don't know about."



"But our bottom-line analysis as to why raloxifene universally reduces the risk of developing invasive cancer in women without a family history is that it interferes with the duration and concentration of estrogen, which acts as a tumor promoter in the majority of breast cancers," said Dr. Lippman.



The research team conducted a new analysis of the first large study of raloxifene, which tested the ability of the drug to prevent vertebral fractures in 7,705 postmenopausal women diagnosed with osteoporosis. The secondary endpoint of this multi-center, double-blind trial, known as MORE (Multiple Outcomes of Raloxifene Evaluation) was the drug's effect on breast cancer development; results, announced in 1999, demonstrated a 72 percent reduction in invasive breast cancer incidence after four years of raloxifene treatment, compared to use of a placebo.



The MORE trial was then extended four years to further evaluate the effect of raloxifene on breast cancer incidence in 4,011 of the original participants. Results of this trial, known as CORE (Continuing Outcomes Relevant to Evista), showed that eight years of raloxifene treatment was associated with a 66 percent decrease in invasive breast cancer incidence.



The current study was undertaken to assess the effect of raloxifene on level of breast cancer risk (higher versus lower) using data from both MORE and CORE.
















Women at higher risk for breast cancer are generally older and have a greater lifetime exposure to estrogen, and the researchers found that this association held true in the reanalysis. But they also found that raloxifene reduced breast cancer risk in both women at lower and those at higher breast cancer risk, except for those women who had measurably low levels of estradiol, the major estrogen hormone in humans.



"In each variable commonly associated with a higher risk for developing breast cancer − age older than 65, age at menopause, a body mass index greater than 25, higher estradiol levels, prior use of estrogen replacement and a family history of breast cancer − use of raloxifene reduced incidence of breast cancer when compared to a placebo drug," Dr. Lippman said. "But it also reduced incidence in each of those variables that should have lowered risk, such as younger age, later menopause, etc., compared to use of a placebo drug."



"We don't define the lowest limit of risk, the point at which toxicity associated with use of raloxifene outweighs the benefits," he said.



Dr. Lippman stressed that he cannot comment on how raloxifene in this study measures up to tamoxifen use in general. He explains that although these findings come on the heels of the June publication of the 19,747-participant STAR trial, which evaluated tamoxifen against raloxifene in reducing breast cancer risk, no comparison can be made between the MORE, CORE and STAR clinical trials.



"These studies looked at two different groups of women," Dr. Lippman said. "Women enrolled in STAR were at high risk for developing breast cancer, so presumably, they had higher levels of estrogen in general. Women who participated in MORE and CORE were older and had osteoporoses and it is assumed that these women generally have lower levels of estrogen, because that is a risk factor for development of the disorder."



Raloxifene, also known by the trade name Evista, has not been approved by the federal Food and Drug Administration as an agent to prevent breast cancer development.



Co-authors of the study include investigators from the University of Pittsburgh, the Angeles Clinic and Research Institute, California Pacific Medical Center Research Institute, and Eli Lilly & Company, which manufactures raloxifene.


American Association for Cancer Research

aacr


View drug information on Estradiol Transdermal System; Evista.

Antares Pharma And Population Council Announce Positive Phase 2 Trial Results

Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.


This first of its kind contraceptive gel may offer an attractive option for women. The combination of Nestorone, a highly potent and versatile synthetic progestin, and the natural estrogen estradiol, was chosen due to the potential for superior safety profiles when compared to other commonly used hormones in contraceptives. The ATD system is currently utilized in Elestrin® a marketed product for hormone replacement therapy (HRT) in postmenopausal women. The gel is easy to apply, crystal clear, fast drying and cosmetically appealing.


The trial was a dose-finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel on ovulation suppression in normal women of fertile age. Eighteen women participated in the trial, which took place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile. Each woman completing the study received each of the three separate doses of the gel for 21 days, separated by a washout month in which no products were administered when they recovered normal ovulation. The primary objective of the study was to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives included determining the plasma profile of estradiol and the evaluation of bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, was also assessed.


Active treatment concluded in October 2009. Safety and efficacy objectives were met and no serious adverse events or instances of skin irritation were recorded.


R?©gine Sitruk-Ware, executive director for research and development in the Reproductive Health program of the Population Council, said, "We have demonstrated that the transdermal gel combining Nestorone and estradiol is able to suppress ovulation at all doses tested and we determined the dose that gave the most stable levels of hormones to the subjects. Most women who participated in the study found the gel very easy to use and convenient. We believe this new formulation is likely to be a safe and effective contraceptive that offers a new option for women who may be unable to use alternative forms of contraception."















"The advantage of using transdermal delivery has been seen with HRT products where recent studies have shown a reduced side effects profile when compared to orally administered products. The ATD system offers a patient friendly, fast drying and cosmetically appealing gel product which can be easily applied daily. This product may offer an excellent opportunity to provide the most safe and effective contraception through an innovative drug delivery system in a large and growing global market segment," said Dario N. Carrara Ph.D., Antares Senior Vice President and Managing Director and the inventor of the ATD system.


The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. According to Business Insights (2007) the contraceptive market is projected to reach $7.5 billion by 2011.


Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council's patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management.


Source

Antares Pharma

Population Council


View drug information on Elestrin; Estradiol Transdermal System.

Heated Nanoprobes Used To Destroy Breast Cancer Cells In Mice

In experiments with laboratory mice that bear aggressive human breast cancers, UC Davis researchers have used hot nanoprobes to slow the growth of tumors -- without damage to surrounding healthy tissue. The researchers describe their work in the March issue of the Journal of Nuclear Medicine.



"We have demonstrated that the system is feasible in laboratory mice. The next step will be clinical testing in patients," said Sally DeNardo, a professor of internal medicine and radiology at UC Davis and lead author of the study.



Many researchers have studied heat as a potential treatment for cancer, but the difficulty of confining heat within the tumor and predicting an effective heat dose has limited its use. The UC Davis research, carried out in collaboration with scientists from Triton BioSystems in Boston, seeks to solve this problem.



The experimental system uses bioprobes created by wedding magnetized iron-oxide nanospheres to radiolabeled monoclonal antibodies. The bioprobes are cloaked in polymers and sugars that render them nearly invisible to the body's immune system.



DeNardo and her colleagues infused trillions of the probes -- more than 10,000 can fit on the end of a straight pin -- into the bloodstreams of laboratory mice bearing human breast tumors. Once in the bloodstream, the probes began to seek out and latch onto receptors on the surface of malignant cells.



Three days later, the team applied an alternating magnetic field to the tumor region, causing the magnetic nanospheres latched onto the tumor cells to change polarity thousands of times per second, instantaneously generating heat. As soon as the AMF stopped, the bioprobes cooled down.



Mice in the study received a series of AMF bursts in a single 20-minute treatment. Dosing was calculated using an equation that included tumor concentration of bioprobes, heating rate of particles at different amplitudes, and the spacing of AMF bursts.



Tumor growth rate slowed in the treated animals, a response that correlated closely with heat dose. No toxicity related to the bioprobes was observed.



"Using heat to kill cancer cells isn't a new concept," DeNardo said. "The biggest problems have been how to apply it to the tumor alone, how to predict the amount needed and how to determine its effectiveness. By combining nanotechnology, focused AMF therapy and quantitative molecular imaging techniques, we have developed a safer technique that could join other modalities as a treatment for breast and other cancers."







DeNardo, co-director of the Radiodiagnosis and Therapy Program at UC Davis, was the first investigator to use monoclonal antibodies in the delivery of radioimmunotherapy when she generated monoclonal antibodies against mouse melanoma in 1979. She was also the first to demonstrate that radioimmunotherapy can be effective in the treatment of non-Hodgkin's B-cell lymphoma and chronic lymphocytic leukemia, and the first to describe the clinical use of radioimmunotherapy coupled with a biologically active antibody to treat breast cancer.



UC Davis Cancer Center is the nation's 61st National Cancer Institute center. Its research program unites more than 275 scientists from more than a dozen disciplines on three campuses: the University of California, Davis, the UC Davis Medical Center in Sacramento, and Lawrence Livermore National Laboratory in Livermore, Calif.



Public Affairs


UC Davis Health System

4900 Broadway, Suite 1200

Sacramento, CA 95820




Contact: Claudia Morain


University of California, Davis - Health System

Adolescent Female Users Of Facebook More Prone To Eating Disorders

The more time adolescent girls spend in front of Facebook, the more their chances of developing a negative body image and various eating disorders, such as anorexia, bulimia and exaggerated dieting. This has been shown in a new study from the University of Haifa.



Eating disorders include a wide spectrum of abnormal mental and behavioral conducts related to food and body weight, such as anorexia nervosa and bulimia nervosa. This study, conducted by Prof. Yael Latzer, Prof. Ruth Katz and Zohar Spivak of the Faculty of Social Welfare and Health Sciences at the University of Haifa, set out to examine the effects of two factors on the development of eating disorders in young girls: exposure to the media and self-empowerment.



A group of 248 girls aged 12-19 (average age: 14.8) took part in the survey. These girls were asked to provide information on their Internet and television viewing habits. Regarding the latter, they were asked to give the number of popular shows related to extreme standards of physical image (the "Barbie" model) that they watched. The girls also filled out questionnaires that examined their approach to slimming, bulimia, physical satisfaction or dissatisfaction, their general outlook on eating, and their sense of personal empowerment.



The results showed that the more time girls spend on Facebook, the more they suffered conditions of bulimia, anorexia, physical dissatisfaction, negative physical self-image, negative approach to eating and more of an urge to be on a weight-loss diet. Extensive online exposure to fashion and music content showed similar tendencies, but manifested in fewer types of eating disorders. As such, the more the exposure to fashion content on the Internet, the higher a girl's chances of developing anorexia. A similar direct link was found between viewing gossip- and leisure-related television programs (the likes of "Gossip Girl") and eating disorders in adolescent girls. The study also revealed that the level of personal empowerment in these girls is negatively linked to eating disorders, such that the higher the level of empowerment, the more positive the physical self-image and the lower the chances of developing an eating disorder.



In this study, exposure to the media and the consequential sense of personal empowerment was found to be associated to parenting practices. Girls whose parents were involved in their media usage; who knew what they were viewing and reading and where they were surfing on the web; who watched, surfed or read along with them; and who conducted cooperative and critical discussions with their daughters about the content of their surfing habits, showed more personal empowerment, forming a protective shield against eating disorders.



On the other hand, parents who were not involved in their media exposure, were not aware of the content that their daughters were consuming, and instead of sharing and becoming familiar with that content chose to limit or prohibit exposure, led to lower self-empowerment in their daughters. This, in turn, has a positive link to various eating problems and negative body image.



"Significant potential for future research and application of eating disorder prevention lies in an understanding of how parenting decisions can have effect on an adolescent girl's sense of empowerment and that enforcing a girl's sense of empowerment is a means to strengthening body image. This study has shown that a parent has potential ability to prevent dangerous behavioral disorders and negative eating behavior in particular," the researchers stated.



Source:

Rachel Feldman


University of Haifa

Northern Kentucky Catholic Bishop Tells Priests Not To Associate With Antiabortion Group; Bars Group From Diocese Churches

The bishop of the Catholic Diocese of Covington, Ky., last week wrote a letter to priests saying they should have "no involvement" with the antiabortion group Right to Life of Northern Kentucky, and "[n]o one is saying exactly what caused the split," the AP/Lexington Herald-Leader reports. In addition, the antiabortion group has been barred from the diocese churches, according to the AP/Herald-Leader. NKRTL -- which "has been known" for criticizing political candidates who do not share its views on emergency contraception, abortion and stem cell research -- recently distributed its literature along with other antiabortion groups at the diocese's annual "Pro-Life Mass," held at the St. Mary's Cathedral Basilica of the Assumption, the AP/Herald-Leader reports. "There are many good people involved in NKRTL who are being misled," Bishop Roger Foys wrote to the priests of the diocese, adding, "We cannot give any semblance that the diocese approves of the tactics of some of the leadership of NKRTL." Diocese spokesperson Tim Fitzgerald declined a request for an interview with Foys but said the diocese has concerns about "inaccuracies" in NKRTL's newsletters and "tactics" the group used. NKRTL Vice President Fred Summe said Foys had not spoken to the group about issues the diocese has with the group, adding, "You'd think the diocese would encourage us. They need to be specific in what they think we're doing wrong" (Barrouquere, AP/Lexington Herald-Leader, 10/26).

"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.

Experts Confirm Favorable Benefit-risk Profile Of Combined Oral Contraceptives

Leading experts in the fields of gynecology, reproductive endocrinology, hematology and epidemiology have affirmed that for most women the low absolute risks of combined oral contraceptives (COCs) are outweighed by the well-established benefits of hormonal contraception.


Their consensus opinion has just been published in the Journal for Family Planning and Reproductive Health (J Fam Plann Reprod Health Care 2010; 36(3): 117 - 122)(1).


For most healthy women the benefits of COCs will outweigh the risks, but it is important to identify the individual risk factors for venous thromboembolism (VTE) the consensus opinion states.


Two publications(2,3) of 2007 dealing with venous thromboembolism in women using an ethinylestradiol / drospirenone-based COC (Yasmin®) were followed in 2009 by others(4,5) with conflicting findings about the risk of VTE with this product. This led Bayer Schering Pharma as the leading company in the field of oral contraception to convene a workshop in December 2009 in Berlin and invite experts in gynecology, reproductive endocrinology, hematology and epidemiology to critically review all recent publications in order to understand the reasons for divergent results.


Following the two-day symposium the experts issued the consensus paper now published by the Journal of Family Planning and Reproductive Health. The paper states that:



-- Modern COCs are reliable, well tolerated contraceptives which also offer a variety of non-contraceptive benefits ranging from regulation and reduction of both menstrual bleeding and dysmenorrhoea to treatment of premenstrual syndrome, acne and hirsutism. Long-term benefits include reduced rates of endometrial and ovarian cancer.



-- Modern COCs are well tolerated and serious side effects are rare in COC users.



-- VTE remains a rare but potentially serious complication of COC use. It is similar for all modern low dosed COCs.



-- The absolute risk of venous thromboembolism is low. The incidence of venous thromboembolism among women who do not take the COCs is about 4 to 5 per 10,000 women per annum. Among women who take COCs, this risk doubles to 9 to 10 cases of venous thromboembolism per 10,000 women per annum. By contrast, during pregnancy the risk rises to about 20 to 30 cases of venous thromboembolism per 10,000 women per annum and after childbirth to about 300 to 400 cases of venous thromboembolism per 10,000 women per annum.



-- As one of the most widely used and effective contraceptive methods, COCs reduce rates of unplanned pregnancies and actually decrease the overall rate of VTE for women in comparison to populations without access to effective contraception.















Controversial findings about VTE risk in different studies


Two studies published in the British Medical Journal in August 2009(4,5) suggested that COCs containing the progestogen drospirenone may have an increased risk of VTE compared to COCs containing levenorgestrel.


Participants of the workshop however found the results of both the Danish study by Lidegaard et al.(4) and the Dutch study by van Hylckama Vlieg et al.(5) could have resulted from methodological flaws and or misinterpretation of the findings.


According to the authors of the consensus paper the Dutch Mega Study showed hazard ratios for various COCs with wide and overlapping 95% confidence intervals indicating no statistically significant difference in the VTE risk between drospirenone-containing COCs and COCs with different progestogens. In recent revisions to the Yasmin product label in the USA, the Food and Drug Administration (FDA) has concluded: "The number of Yasmin cases [in the Dutch Mega Study] was very small (1.2% of all cases) making the risk estimates unreliable."


The authors of the consensus paper also identified several significant methodological weaknesses in the Danish National Cohort Study. Confounders such as obesity, surgery or a family history for VTE were not taken into consideration.


The experts also looked at the two studies published in 2007(3,4). Bayer sponsored as part of its post-approval commitments to EU regulatory authorities and the FDA for drospirenone-containing COCs, two large observational studies (EURAS(3) and Ingenix(4)) in Europe and the United States which were carried out by independent investigators. Both studies were specifically designed after extensive discussion with European and US health regulators to be sufficiently powered to assess differences between COCs with different progestogens with regard to the risk of VTE. EURAS controlled for confounding factors (e.g. Body Mass Index and personal or family history of VTE); Ingenix used recognized epidemiological methods (propensity score matching) to achieve balance between the cohorts. These studies encompassing more than 120,000 COC users confirm that users of low-dose COCs have a similarly low risk of VTE regardless of the progestogen used. The results of the EURAS and Ingenix trials, which were published in 2007, offer important information about the safety of COCs in a real-life setting.


Personal consultation is essential


The experts participating at the workshop emphasized the importance of the consultation which must precede any oral contraceptive prescription. Particularly when it comes to a patient's initial prescription, it is essential that healthcare professionals compile a thorough past medical history to establish a woman's risk profile. The decision on prescription of hormonal contraceptives has to be made based on an individual benefit-risk evaluation. Contraindications and precautions for use as indicated in the package insert also have to be taken into consideration. Known risk factors for VTE include individual or family history for VTE, coagulation disorders, advanced age, cigarette smoking, surgical procedures, long haul flights, obesity, pregnancy and time after child birth.


Studies mentioned in this release


References



1. Reid RL, Westhoff C, Mansour D, de Vries C, Verhaeghe J, Boschitsch E, Gompel A, Birkh?¤user M, Krepelka P, Dulicek P, Iversen O-E, Khamoshina M, Dezman LV, Fruzzetti F, Szarewski A, Wilken-Jensen C, Seidman D, Kaaja R, Shapiro S. Oral Contraceptives and Venous Thromboembolism. Consensus Opinion from an International Workshop held in Berlin, Germany in December 2009. J Fam Plann Reprod Health Care 2010: 36(3), 117 - 122



2. Dinger JC, Heinemann LAJ, K??hl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance study on Oral Contraceptives based on 142,475 women-years of observation, , Contraception 75 (2007) 344 - 354



3. Seeger JD, Loughlin J, Eng M, Clifford R, Cutone J, Walker AM, Risk of Thromboembolism in Women Taking Ethinylestradiol/Drospirenone and Other Oral Contraceptives, Obstetrics & Gynecology, Vol. 110, No. 3, September 2007, 587-593



4. Lidegaard O, L??kkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009:339:b2890.



5. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP , Doggen CJM, Rosendaal FR. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case- control study. BMJ 2009; 339: b2921


About Bayer HealthCare


The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide.


About Bayer Schering Pharma


Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.


Forward-Looking Statements


This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


Source: Bayer Schering Pharma

Cheerleading Is Leading Cause Of Catastrophic Injury In Young Women

As a bright, young cheerleader trying out for the high school varsity squad, 14-year-old Laura Jackson had everything going for her.


But when a back flip went wrong during a try-out without a trained spotter on hand, Laura landed on her head fracturing her neck and damaging her spinal cord. Laura is now paralyzed and breathes with the help of a ventilator.


Cheerleading has become the leading cause of catastrophic injury in young female athletes, says Amy Miller Bohn, a physician at the UMHS department of family medicine.


Data from the Consumer Product Safety Commission shows that rates of injuries from cheerleading accidents have gone from nearly 5,000 in 1980 to close to 26,000 to 28,000 in the past few years, Miller Bohn says.


In addition, the leading cause of catastrophic injuries in female athletes is cheerleading, according to The National Center for Catastrophic Sports Injury Research. They account for approximately 65 to 66 percent of all female catastrophic injuries in either high school or college.


"If you look at cheerleading injuries, most of them are still more the common types of things that we should think about - muscle strains or pulls, ligament injuries, tendon injuries," Miller Bohn says. "The concern is that there are certainly a fair number of increasingly severe injuries."


Because of the increase in degree of difficulty in cheerleading skills, increased acrobatics and stunt activities may be increasing the risk of severity of injury.


Catastrophic injuries seen in cheerleading involve either death, injuries that results in disability that are often related to head trauma or spine trauma. Doctors are also seeing more injuries that a person may not be able to recover from completely - such as concussions or severe fractures.


Cheerleading injuries appear to be on the rise partly because of an increase in participants, but the sport has also changed significantly in the last 25 years. Cheerleading no longer consists of athletes standing on the sidelines, rooting for a team.


"Cheerleading has become an actual competitive sport," she says.


If participants want to be one of the better teams, compete at high levels and be invited to competitions, athletes must include a higher degree of difficulty and risk in routines. This means fewer traditional pyramids and more tossing people in the air, jumping off pyramids and trying risky stunts," Miller Bohn says.


Miller Bohn believes there aren't enough safety measures in place in schools. Many athletes will practice in places such as a back yard, a hard gym floor or a parking lot. There are often no supportive surfaces to shield them from falls.


Participants also lack adequate supervision. If an adequately trained coach is not present to ensure participants are using proper techniques and make sure spotters are placed where they should, injuries may occur.


In addition, there is no uniformity in training of cheerleading coaches. They can range from a child's parent, a former cheerleader, to someone with a high level of training in gymnastics.


What can parents and school officials do to help prevent injuries?


An area to focus in is coaching staff. It's recommended that a coach have experience in first aid and CPR training. It's also preferred that they have good training in how to coach athletes in regard to their development, strength, conditioning, and flexibility. They should also have experience in coaching and how they perform these activities, technique and how they are supported and monitored, ensuring there's always someone around to be at practices and to be present to make changes if something looks unsafe.


Another area of concern is equipment. A spring loaded floor is a good idea to prevent injuries and to cushion a fall. Mats are also important.


Parents whose children are interested in cheerleading should ask questions about the coach's experience, what type of athletes the coach has worked with and if they have experience with gymnastics stunt work. They also need to know what the plan is for that cheerleading squad, what types of activities they will perform, who is supervising and where activities will be performed.


Resources and safety recommendations can also be found through foundations such as the National Cheer Safety foundation.


Source: University of Michigan Health System