Women have conflicting attitudes about participating in clinical trials because of uncertainties about trusting the experimenters, fear of the trial itself, and hope that the research will result in medical progress, according to a new study at Wake Forest University School of Medicine.
Researchers in the Department of Social Sciences and Health Policy said in the February issue of the Journal of Health Care for the Poor and Underserved that they especially focused their research on black women and low socio-economic status white women.
"Enrolling representative populations is essential to the generalizability of study findings," wrote the team - Deborah F. Farmer, Ph.D., Sharon A. Jackson, Ph.D., and Mark A. Hall, J.D. The researchers noted that Congress mandated including women and minorities in clinical trials in 1993, yet women and minorities continue to be under-represented.
"The results of our study demonstrate the willingness of at least some African-American and low socioeconomic status white women to participate in research if it will benefit them or their families, advance scientific knowledge and help others in the future," they wrote. "But they must trust the researchers to be ethical and upfront with them about what is required, fully disclose what will happen to the health information they provide, and put their best interests first."
The Wake Forest team enrolled 72 women - 52 black women from a range of income levels and 20 low-income white women - and placed them in 10 focus groups. Three themes emerged from analysis of the focus group discussions - fear, distrust and hope.
"The attitude of fear was expressed in terms of not wanting to be a guinea pig or doing something that no one has done before," the team wrote. The women also recalled the Tuskegee Syphilis Study, in which black men went untreated even after effective treatment for syphilis became available.
(According to the Centers for Disease Control and Prevention, "The Tuskegee Syphilis Study, carried out in Macon County, Ala., from 1932 to 1972, is an example of medical research gone wrong. The U. S. Public Health Service, in trying to learn more about syphilis and justify treatment programs for blacks, withheld adequate treatment from a group of poor black men who had the disease, causing needless pain and suffering for the men and their loved ones.")
In the focus groups, distrust of investigators also emerged, viewing them "as self-promoting individuals who use consent forms to protect themselves against lawsuits and who do not disclose all facets and risks associated with study participation."
On the other hand, "participants expressed hope that research would help them and others in the future prevent diseases, find cures, change attitudes and lead to advances in knowledge and the eventual approval of new drugs," the researchers say in the article. That was especially true for health conditions that affected them or their families.
The women listed a number of other reasons for not participating in clinical trials: "location of the study, time of day that the study was held, duration and time commitment of participation, availability of parking, and provision of child care."
The women also feared finding out they had a disease as a result of tests and medical procedures done as part of the study.
The researchers added, "Participants also expressed fears and worries about the long-term effects of treatment, possible complications and side effects, embarrassment, fear of the unknown and even the possibility of death??¦. They also expressed uncertainty about study medications and not knowing whether they were on a placebo, the possibility that the medicine might not work for them, and the strong feeling they didn't want to be experimented on."
Participants also took a physician trust scale. Older women had significantly higher trust scores than younger women. Trust scores did not vary by ethnicity.
To counter the negatives, the researchers called for greater involvement of academic medical centers with minority or low socioeconomic status communities where they could become partners in research to address health problems and concerns of the community. They noted, "This type of research partnership takes time to establish and maintain."
Hall is professor of public health sciences and professor of law. Farmer is now assistant professor of gerontology in the Department of Social Sciences at Winston-Salem State University, and Jackson is now a contractor for Northrop Grumman assigned to the Centers for Disease Control and Prevention in Atlanta. Another member of the research team was Fabian Camacho, M.S., of Wake Forest. The study was paid for by a grant from the Women's Health Center of Excellence at Wake Forest.
Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. U.S. News & World Report ranks Wake Forest University School of Medicine 18th in family medicine, 20th in geriatrics, 25th in primary care and 41st in research among the nation's medical schools. It ranks 35th in research funding by the National Institutes of Health. Almost 150 members of the medical school faculty are listed in Best Doctors in America.
Contact: Karen Richardson
Wake Forest University Baptist Medical Center
вторник, 28 июня 2011 г.
воскресенье, 26 июня 2011 г.
Nike Foundation Calls On Global HIV-Prevention Initiatives To Focus On Girls
Against the backdrop of World AIDS Week, the Nike Foundation has launched a global effort with government partners to put adolescent girls in developing countries at the center of HIV-prevention strategies.
Every day, 6,000 young people ages 15 to 24 become infected with HIV. Two-thirds of these new cases are girls. Yet, although girls face the greatest risks, prevention strategies to date have not put them at the core. Girls who are most at risk are also the hardest to reach - often isolated in marriage from a very young age, and not in school.
"This is an emergency. In Africa 75 percent of young people living with HIV are female, up from 62 percent in 2001," said Lisa MacCallum, Managing Director of the Nike Foundation. "We keep avoiding the epicenter of the epidemic, and it's not working. The only way to halt the spread of HIV is to put girls at the center of HIV prevention by investing in comprehensive programs that address the combination of girls' education, health, safety and economic empowerment."
On December 3, the Nike Foundation, the United Nations Foundation and UNAIDS co-hosted "The Girl Effect: HIV/AIDS Prevention Starts with a Girl," a private meeting in Dakar, Senegal attended by more than 100 ministers of health, business leaders, global NGOs and AIDS ambassadors. Dr. Peter Piot, Executive Director of UNAIDS, gave the keynote address.
"We know that in many countries of Africa girls and young women are the most vulnerable to HIV infection. Strategies focused on them must be built directly into national responses to AIDS and attached to budget allocations substantial enough to take them to scale," said Dr. Piot. "If we don't invest in girls now, the consequences will be dire for the entire next generation."
Today in Nairobi, Kenya, the Nike Foundation joined 15 other corporate, foundation and NGO partners and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in launching the Partnership for an HIV-Free Generation. The Foundation will provide expertise in unleashing the girl effect - the power of adolescent girls in developing countries to bring unprecedented economic and social change to their families, communities and countries. Investments in the girl effect will demonstrate the most effective combinations of girl-focused programs to keep girls free of HIV.
Prior to the launch event, eight girls participated in a roundtable discussion with key dignitaries to talk about their personal experiences and how they're working to stop the spread of HIV in their communities. Four of the girls are participants in Binti Pamoja and TechnoServe's programs in Kenya - two Nike Foundation partners that are working to unleash the girl effect.
Binti Pamoja provides a safe space for adolescent girls to explore issues prevalent in their daily lives in Kibera, an urban slum in Nairobi that is home to one million people. The model is designed to grow virally, as graduates establish new safe spaces throughout Kibera. Girls participating from Binti include:
-- Maureen Atieno, 18, is a community organizer in Kibera. She has recruited girls from her immediate community to participate in Binti Pamoja's programs and works with the "Kicking AIDS Out" program.
-- Stephanie Shipemo, 20, also lives in the slum of Kibera. She became pregnant at 17 as a result of rape. Like most girls in that dire situation, Stephanie left school. Unlike most girls, she came back after her child was born. Completing fourth form this year, she is a peer educator at Binti Pamoja where she teaches 40 younger girls how to survive in the tough conditions of Kibera.
TechnoServe has established a first-of-its kind business plan competition for girls ages 15 to 22 with prizes that enable girls to start businesses, along with a pilot program focused on helping micro-entrepreneurs turn their enterprises into growing small businesses. Girls attending from TechnoServe include:
-- Cecilia Katungwa, 23, lives in Mukuru Fuatanyayo with her brother and younger sister. A winner of TechnoServe's business plan competition, Cecilia established a knitting and design business two years ago.
-- Joyce Waithaka, 20, first encountered TechnoServe in an enterprise club at her Muchatha school. She graduated with the determination to become a businesswoman and today she is just that. She supports herself and employs two young women her same age, so that they can also support themselves and not engage in risky behaviors.
"Girls like me in Kenya today may be more vulnerable to HIV, but we're determined to be the solution, not victims of this disease," said Katungwa. "Working with TechnoServe gave me the confidence and skills to become a businesswoman and set my own future. Because of my business I have choices that help keep me safe and HIV free. And today, I employ other girls from Nairobi's slums so I can pass on what I learn and keep them HIV free too."
The week's events will culminate tomorrow in a youth festival in Nairobi arranged by the Partnership for an HIV-Free Generation to launch Jipange! ("Get yourself together"), a youth-oriented lifestyle brand focused on knowing one's status and learning the facts about HIV. Thousands of youth will attend the festival featuring popular African music and dance performers.
About the Nike Foundation and Nike
The Nike Foundation (hwww.nikefoundation) is a non-profit organization supported by NIKE, Inc. (NYSE:NKE), that is dedicated to investing in adolescent girls as the most powerful force for change in the developing world. NIKE, Inc. (www.nikebiz) based near Beaverton, Oregon, is the world's leading designer, marketer and distributor of authentic athletic footwear, apparel, equipment and accessories for a wide variety of sports and fitness activities.
Every day, 6,000 young people ages 15 to 24 become infected with HIV. Two-thirds of these new cases are girls. Yet, although girls face the greatest risks, prevention strategies to date have not put them at the core. Girls who are most at risk are also the hardest to reach - often isolated in marriage from a very young age, and not in school.
"This is an emergency. In Africa 75 percent of young people living with HIV are female, up from 62 percent in 2001," said Lisa MacCallum, Managing Director of the Nike Foundation. "We keep avoiding the epicenter of the epidemic, and it's not working. The only way to halt the spread of HIV is to put girls at the center of HIV prevention by investing in comprehensive programs that address the combination of girls' education, health, safety and economic empowerment."
On December 3, the Nike Foundation, the United Nations Foundation and UNAIDS co-hosted "The Girl Effect: HIV/AIDS Prevention Starts with a Girl," a private meeting in Dakar, Senegal attended by more than 100 ministers of health, business leaders, global NGOs and AIDS ambassadors. Dr. Peter Piot, Executive Director of UNAIDS, gave the keynote address.
"We know that in many countries of Africa girls and young women are the most vulnerable to HIV infection. Strategies focused on them must be built directly into national responses to AIDS and attached to budget allocations substantial enough to take them to scale," said Dr. Piot. "If we don't invest in girls now, the consequences will be dire for the entire next generation."
Today in Nairobi, Kenya, the Nike Foundation joined 15 other corporate, foundation and NGO partners and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in launching the Partnership for an HIV-Free Generation. The Foundation will provide expertise in unleashing the girl effect - the power of adolescent girls in developing countries to bring unprecedented economic and social change to their families, communities and countries. Investments in the girl effect will demonstrate the most effective combinations of girl-focused programs to keep girls free of HIV.
Prior to the launch event, eight girls participated in a roundtable discussion with key dignitaries to talk about their personal experiences and how they're working to stop the spread of HIV in their communities. Four of the girls are participants in Binti Pamoja and TechnoServe's programs in Kenya - two Nike Foundation partners that are working to unleash the girl effect.
Binti Pamoja provides a safe space for adolescent girls to explore issues prevalent in their daily lives in Kibera, an urban slum in Nairobi that is home to one million people. The model is designed to grow virally, as graduates establish new safe spaces throughout Kibera. Girls participating from Binti include:
-- Maureen Atieno, 18, is a community organizer in Kibera. She has recruited girls from her immediate community to participate in Binti Pamoja's programs and works with the "Kicking AIDS Out" program.
-- Stephanie Shipemo, 20, also lives in the slum of Kibera. She became pregnant at 17 as a result of rape. Like most girls in that dire situation, Stephanie left school. Unlike most girls, she came back after her child was born. Completing fourth form this year, she is a peer educator at Binti Pamoja where she teaches 40 younger girls how to survive in the tough conditions of Kibera.
TechnoServe has established a first-of-its kind business plan competition for girls ages 15 to 22 with prizes that enable girls to start businesses, along with a pilot program focused on helping micro-entrepreneurs turn their enterprises into growing small businesses. Girls attending from TechnoServe include:
-- Cecilia Katungwa, 23, lives in Mukuru Fuatanyayo with her brother and younger sister. A winner of TechnoServe's business plan competition, Cecilia established a knitting and design business two years ago.
-- Joyce Waithaka, 20, first encountered TechnoServe in an enterprise club at her Muchatha school. She graduated with the determination to become a businesswoman and today she is just that. She supports herself and employs two young women her same age, so that they can also support themselves and not engage in risky behaviors.
"Girls like me in Kenya today may be more vulnerable to HIV, but we're determined to be the solution, not victims of this disease," said Katungwa. "Working with TechnoServe gave me the confidence and skills to become a businesswoman and set my own future. Because of my business I have choices that help keep me safe and HIV free. And today, I employ other girls from Nairobi's slums so I can pass on what I learn and keep them HIV free too."
The week's events will culminate tomorrow in a youth festival in Nairobi arranged by the Partnership for an HIV-Free Generation to launch Jipange! ("Get yourself together"), a youth-oriented lifestyle brand focused on knowing one's status and learning the facts about HIV. Thousands of youth will attend the festival featuring popular African music and dance performers.
About the Nike Foundation and Nike
The Nike Foundation (hwww.nikefoundation) is a non-profit organization supported by NIKE, Inc. (NYSE:NKE), that is dedicated to investing in adolescent girls as the most powerful force for change in the developing world. NIKE, Inc. (www.nikebiz) based near Beaverton, Oregon, is the world's leading designer, marketer and distributor of authentic athletic footwear, apparel, equipment and accessories for a wide variety of sports and fitness activities.
суббота, 25 июня 2011 г.
Once-yearly Treatment Significantly Reduces Bone Fractures In Women With Postmenopausal Osteoporosis
Data to be published in this week's issue of The New England Journal of Medicine show that a once-yearly treatment significantly reduced the incidence of all types of osteoporotic bone fractures over three years in women with postmenopausal osteoporosis. The publication marks the first time that an osteoporosis treatment significantly reduced all types of fractures in a single study.
The Phase III clinical study involved more than 7,700 women between the ages of 65 and 89 in 27 countries. All women involved in the study had postmenopausal osteoporosis and received Reclast® (zoledronic acid) Injection or placebo. Results from the study show that Reclast reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine, and wrist. Specifically, a 70 percent reduction was achieved in spine fractures. The risk of hip fractures, which are associated with significant mortality, was reduced by 41 percent.
The study also showed bone mineral density increased significantly in the spine by 6.7 percent and in the hip by 6 percent in women on Reclast compared to those who received placebo.
Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis. Unlike other bisphosphonate treatments that require women to take daily, weekly, or monthly doses for postmenopausal osteoporosis, Reclast is given as a once-yearly 15-minute infusion.
Osteoporosis affects more than 10 million people in the U.S. An estimated one out of two women over age 50 will suffer an osteoporosis-related fracture in her lifetime.
The FDA is currently reviewing Reclast for the treatment of postmenopausal osteoporosis. The FDA has approved the drug for the treatment of Paget's disease of bone, the second most common metabolic bone disorder after osteoporosis.
For full prescribing information on Reclast for the treatment of Paget's disease, please visit reclast/
Contact: Russell Grant
Fleishman-Hillard, Inc.
View drug information on Reclast.
The Phase III clinical study involved more than 7,700 women between the ages of 65 and 89 in 27 countries. All women involved in the study had postmenopausal osteoporosis and received Reclast® (zoledronic acid) Injection or placebo. Results from the study show that Reclast reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine, and wrist. Specifically, a 70 percent reduction was achieved in spine fractures. The risk of hip fractures, which are associated with significant mortality, was reduced by 41 percent.
The study also showed bone mineral density increased significantly in the spine by 6.7 percent and in the hip by 6 percent in women on Reclast compared to those who received placebo.
Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis. Unlike other bisphosphonate treatments that require women to take daily, weekly, or monthly doses for postmenopausal osteoporosis, Reclast is given as a once-yearly 15-minute infusion.
Osteoporosis affects more than 10 million people in the U.S. An estimated one out of two women over age 50 will suffer an osteoporosis-related fracture in her lifetime.
The FDA is currently reviewing Reclast for the treatment of postmenopausal osteoporosis. The FDA has approved the drug for the treatment of Paget's disease of bone, the second most common metabolic bone disorder after osteoporosis.
For full prescribing information on Reclast for the treatment of Paget's disease, please visit reclast/
Contact: Russell Grant
Fleishman-Hillard, Inc.
View drug information on Reclast.
Family Planning Industry In Massachusetts Thriving During Recession
The family planning industry in Massachusetts is flourishing during the economic recession, according to state medical experts, the Boston Herald reports. Planned Parenthood has reported a 77% increase in the state for procedures to insert intrauterine devices, and physicians are seeing higher numbers of vasectomy procedures. In addition, condom sales are increasing.
A recent Gallup survey conducted for the American College of Obstetricians and Gynecologists found that 17% of married women said the economy has affected their plans to have children, and 33% of women who are in a relationship but not married said they are now more concerned with unintended pregnancies compared with the previous year.
Jesse Mermell, vice president of external affairs for the Planned Parenthood League of Massachusetts, said that NuvaRing and long-term IUD use has increased by 77% in the past year. Mermell said, "The universal reaction to that spike has been 'wow.'"
According to Nelson Bennett, director of male sexual medicine at the Lahey Clinic, there was a 30% increase in vasectomies in the first quarter of 2009 compared with the same period in 2008. Emanuel Friedman of MetroWest Urology -- who has performed about 1,500 vasectomies -- said, "People who wanted four children might now stop at two," adding, "Last year I was doing four to six surgeries weekly, now I'm doing six to 10."
Davin Wedel, president of Glob Protection, a Boston-based condom manufacturer, said that condom sales "are up, even in retail, which is rare." His company has seen a 35% increase in online traffic from its flagship brand's Web site. He added that the increase is not only because of couples being more careful. "People are out of work, and sex is a cheap form of entertainment," he said.
According to the Herald, area hospitals have not yet seen a steep drop in the number of newborns, but representatives say it is still too early to forecast how the economy will affect birthrates. August marks the ninth month since the start of the recession (Jordan, Boston Herald, 8/2).
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.
View drug information on NuvaRing.
A recent Gallup survey conducted for the American College of Obstetricians and Gynecologists found that 17% of married women said the economy has affected their plans to have children, and 33% of women who are in a relationship but not married said they are now more concerned with unintended pregnancies compared with the previous year.
Jesse Mermell, vice president of external affairs for the Planned Parenthood League of Massachusetts, said that NuvaRing and long-term IUD use has increased by 77% in the past year. Mermell said, "The universal reaction to that spike has been 'wow.'"
According to Nelson Bennett, director of male sexual medicine at the Lahey Clinic, there was a 30% increase in vasectomies in the first quarter of 2009 compared with the same period in 2008. Emanuel Friedman of MetroWest Urology -- who has performed about 1,500 vasectomies -- said, "People who wanted four children might now stop at two," adding, "Last year I was doing four to six surgeries weekly, now I'm doing six to 10."
Davin Wedel, president of Glob Protection, a Boston-based condom manufacturer, said that condom sales "are up, even in retail, which is rare." His company has seen a 35% increase in online traffic from its flagship brand's Web site. He added that the increase is not only because of couples being more careful. "People are out of work, and sex is a cheap form of entertainment," he said.
According to the Herald, area hospitals have not yet seen a steep drop in the number of newborns, but representatives say it is still too early to forecast how the economy will affect birthrates. August marks the ninth month since the start of the recession (Jordan, Boston Herald, 8/2).
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.
View drug information on NuvaRing.
Launch Of Nation-wide Study For Early Detection Of Ovarian Cancer
A multidisciplinary team of researchers from the McGill University Health Centre (MUHC), and the universities of Sherbrooke, Laval, Quebec, McGill and Calgary have launched a multi-centre study designed for early identification of women at risk of ovarian cancer (OC).
The study known as "DOVE - Detecting OVarian Cancer Earlier" is the initiative of gynecological oncologist, Dr Lucy Gilbert of the McGill University Health Centre (MUHC). Gilbert and a team of gynecological oncologists, family practitioners, general gynecologists, mathematicians, epidemiologists and scientists from centres across Canada have combined their medical expertise to defeat this disease. Although ovarian cancer is considered "the silent killer", there are numerous studies that show that women with ovarian cancer are symptomatic but unfortunately because the signs are vague and non-specific in nature, they are ignored by women and their doctors.
"Ovarian cancer is the fourth leading cause of cancer death in women and deadliest of the gynecological cancers" says Dr. Lucy Gilbert, the principal investigator in the study. "The statistics are alarming and a reliable assessment tool to detect this disease early and while it is treatable (in stage 1 of the disease) must be developed without delay. We owe this to women and the DOVE team is determined to work on achieving this goal," she explains.
Of the 2400 new women diagnosed each year more than 75% will die from the disease. Four women die per day in Canada from ovarian cancer because most are diagnosed in the advanced stages of the disease (stages 2 and 3). However, if the cancer is detected early (at stage 1) more than 80% will survive.
"By the time women present to us with ovarian cancer over 60% are already at stage three and four - very advanced stages of the cancer" says gynecological oncologist, Dr. Prafull Ghatage of Calgary's Tom Baker Cancer Centre. "Even with heroic efforts at surgery followed by the best available chemotherapy combination we are able to achieve long term survival in only about 20%".
"Screening women without clearly defined / recognized symptoms is not recommended by the Canadian Task Force on the Periodic Health Examination and the U.S. Preventive Services Task Force because it results in unnecessary major surgery and has the potential to do more harm than good", says Dr Michel Roy of University of Laval. "In the DOVE trial we are working with women who have indications of OC to clearly profile a cluster of symptoms from the 70 or so non-specific symptoms that would identify women with a high likelihood of having the disease", adds Roy who is the president of the 'Regroupement des Gynecologues-Oncologues du Quebec'.
Dr Martin Dawes, Chair of Family Medicine at McGill, and director of Family Medicine at the MUHC explains, "The challenge for doctors who first see the patient is to identify those who do need urgent investigations from those who do not." The Dove study is designed to further ensure that the predictive tool we recommend to family doctors and general gynecologists profiles ovarian cancer as precisely as possible, so the system is neither swamped by over-investigating, nor is there undue delay in identifying women with cancer. "The only way to defeat this deadly disease is if primary, secondary and tertiary care services work as real partners', he emphasizes.
Epidemiologists, Dr.Marie-Elise Parent of Institut Armand-Frappier, University of Quebec, and Dr. James Hanley of McGill University will be instrumental in ensuring that the predictive tool is refined and tested in three phases to ensure that it profiles early ovarian cancer as precisely as possible. "In Phase I we will identify an accurate symptom profile and develop a reliable diagnostic tool to detect ovarian cancer. In phase II we will refine and validate this tool and by phase three, we will be able to take the prediction tool and apply it to the community to fast-track women with suspected OC", says Dr. Duarte-Franco, the trial coordinator.
In addition to identifying women with OC symptoms early, the Dove trial will also allow scientists to compare large numbers of cancer patients with controls, identifying not just the clinical or symptom profiles of women with ovarian cancer, but also their molecular biology profile. Dr. Michel Tremblay, Director of the McGill Cancer Centre, and his team will work on identifying genetic and proteonomic markers that may allow detection of the disease even before symptoms set in.
About the McGill University Health Centre (MUHC)
The McGill University Health Centre (MUHC) is a comprehensive academic health institution with an international reputation for excellence in clinical programs, research and teaching. The MUHC is a merger of five teaching hospitals affiliated with the Faculty of Medicine at McGill University - the Montreal Children's, Montreal General, Royal Victoria, and Montreal Neurological Hospitals, as well as the Montreal Chest Institute. Building on the tradition of medical leadership of the founding hospitals, the goal of the MUHC is to provide patient care based on the most advanced knowledge in the health care field, and to contribute to the development of new knowledge.
Contact: Seeta Ramdass
McGill University
The study known as "DOVE - Detecting OVarian Cancer Earlier" is the initiative of gynecological oncologist, Dr Lucy Gilbert of the McGill University Health Centre (MUHC). Gilbert and a team of gynecological oncologists, family practitioners, general gynecologists, mathematicians, epidemiologists and scientists from centres across Canada have combined their medical expertise to defeat this disease. Although ovarian cancer is considered "the silent killer", there are numerous studies that show that women with ovarian cancer are symptomatic but unfortunately because the signs are vague and non-specific in nature, they are ignored by women and their doctors.
"Ovarian cancer is the fourth leading cause of cancer death in women and deadliest of the gynecological cancers" says Dr. Lucy Gilbert, the principal investigator in the study. "The statistics are alarming and a reliable assessment tool to detect this disease early and while it is treatable (in stage 1 of the disease) must be developed without delay. We owe this to women and the DOVE team is determined to work on achieving this goal," she explains.
Of the 2400 new women diagnosed each year more than 75% will die from the disease. Four women die per day in Canada from ovarian cancer because most are diagnosed in the advanced stages of the disease (stages 2 and 3). However, if the cancer is detected early (at stage 1) more than 80% will survive.
"By the time women present to us with ovarian cancer over 60% are already at stage three and four - very advanced stages of the cancer" says gynecological oncologist, Dr. Prafull Ghatage of Calgary's Tom Baker Cancer Centre. "Even with heroic efforts at surgery followed by the best available chemotherapy combination we are able to achieve long term survival in only about 20%".
"Screening women without clearly defined / recognized symptoms is not recommended by the Canadian Task Force on the Periodic Health Examination and the U.S. Preventive Services Task Force because it results in unnecessary major surgery and has the potential to do more harm than good", says Dr Michel Roy of University of Laval. "In the DOVE trial we are working with women who have indications of OC to clearly profile a cluster of symptoms from the 70 or so non-specific symptoms that would identify women with a high likelihood of having the disease", adds Roy who is the president of the 'Regroupement des Gynecologues-Oncologues du Quebec'.
Dr Martin Dawes, Chair of Family Medicine at McGill, and director of Family Medicine at the MUHC explains, "The challenge for doctors who first see the patient is to identify those who do need urgent investigations from those who do not." The Dove study is designed to further ensure that the predictive tool we recommend to family doctors and general gynecologists profiles ovarian cancer as precisely as possible, so the system is neither swamped by over-investigating, nor is there undue delay in identifying women with cancer. "The only way to defeat this deadly disease is if primary, secondary and tertiary care services work as real partners', he emphasizes.
Epidemiologists, Dr.Marie-Elise Parent of Institut Armand-Frappier, University of Quebec, and Dr. James Hanley of McGill University will be instrumental in ensuring that the predictive tool is refined and tested in three phases to ensure that it profiles early ovarian cancer as precisely as possible. "In Phase I we will identify an accurate symptom profile and develop a reliable diagnostic tool to detect ovarian cancer. In phase II we will refine and validate this tool and by phase three, we will be able to take the prediction tool and apply it to the community to fast-track women with suspected OC", says Dr. Duarte-Franco, the trial coordinator.
In addition to identifying women with OC symptoms early, the Dove trial will also allow scientists to compare large numbers of cancer patients with controls, identifying not just the clinical or symptom profiles of women with ovarian cancer, but also their molecular biology profile. Dr. Michel Tremblay, Director of the McGill Cancer Centre, and his team will work on identifying genetic and proteonomic markers that may allow detection of the disease even before symptoms set in.
About the McGill University Health Centre (MUHC)
The McGill University Health Centre (MUHC) is a comprehensive academic health institution with an international reputation for excellence in clinical programs, research and teaching. The MUHC is a merger of five teaching hospitals affiliated with the Faculty of Medicine at McGill University - the Montreal Children's, Montreal General, Royal Victoria, and Montreal Neurological Hospitals, as well as the Montreal Chest Institute. Building on the tradition of medical leadership of the founding hospitals, the goal of the MUHC is to provide patient care based on the most advanced knowledge in the health care field, and to contribute to the development of new knowledge.
Contact: Seeta Ramdass
McGill University
Older Women At Highest Risk For Hip Fractures, Least Likely To Get Bone Density Screening
A new study by Medical College of Wisconsin researchers has found that women who most need bone density testing to determine if they have osteoporosis are the least likely to get it. They are older women who are among the highest risk groups and who suffer most if they break a bone. The study is published in the March issue of the Journal of the American Geriatric Society.
"Over half of hip fracture patients never regain their prior level of functioning and 20 percent of them require nursing home care," according to Joan M. Neuner, M.D., M.P.H., lead author and assistant professor of medicine at the Medical College. Dr. Neuner is on the staff at Froedtert Hospital. "Women are very interested in preventing bone fractures. In an earlier study, 80 percent of women said they would "rather die" than enter a nursing home with a hip fracture."
Osteoporosis, in which the body breaks down bone faster than it is replaced, leading to lace-like, fragile bones, is a significant risk for older women. Nineteen percent of women in the age 65-74 group have it, 32.5 percent of women age 75-84, and over half of women over age 85.
The research team did a statistical analysis to see if older women are more or less likely to have the bone density test that would tell them their bone status. The retrospective study ??" one in which they looked at existing data to gain a new understanding ??" looked at the Medicare records of nearly 44,000 women from age 65 to 90 to see how many of them had a bone density test from 1999 (the first year Medicare paid for it) to 2001. They looked at the association between frequency of testing and the age of the women, controlling for factors such as socioeconomic class, race and other diseases they may have had.
"Since osteoporosis can be helped with appropriate therapy, it is especially important for older women to find out whether or not they need the therapy. Treatment with hormones or bone-building drugs can slow the process, rebuild some bone and reduce the risk of fracture by one-third," Dr. Neuner says.
The best scenario would be the oldest women being the most frequent subjects of bone density screenings. That did not prove to be the case. In fact, the research team found just the opposite. The older the age group, the fewer women had bone density tests.
The numbers were not heartening: 27 percent of women in the youngest age group, 65-70, had the test. At age 71-75, only 25.6 percent had it and; after age 75, the number fell to less than 10 percent.
Since this was a statistical study and no women were interviewed, the researchers could not determine the reason why older women failed to get the test. But they offer some possible reasons:
* Physicians not realizing the importance of bone density testing, or not being aware of how great women's life expectancy is ??" at age 80 most women can expect to live another nine years
* Physicians not being aware that osteoporosis treatment can reduce the risk of fracture in just three years
* Women having side effects from the treatment drugs or just not liking to take prescription medications
* Women not realizing that they are at risk, or mistakenly believing that osteoporosis is natural part of aging
The study points out the need for greater patient and physician education to convince women to get the testing they need, especially as they grow older and to determine if osteoporosis therapy would benefit them.
"Preventive care for older patients must be performed with an understanding of their life expectancy and values," Dr. Neuner says. "Osteoporosis screening may offer important opportunities to improve quality of life for many older patients."
The study was funded with a grant from National Institutes of Health. Other members of the research team were Neil Binkley, M.D., associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, Madison; Rodney A. Sparapani, M.S., Health Policy Institute biostatistician; Purushottam W. Laud, Ph.D., professor of the division of biostatistics at the Health Policy Institute; and Ann B. Nattinger, M.D., M.P.H., professor and chief of medicine and Lady Riders Professor of Breast Cancer Research.
Editor's Note:
In a related study, another group of Medical College researchers led by Srividya Kidambi, M.D., currently a fellow in endocrinology, looked at level of knowledge regarding the presence of osteoporosis in African-American women in Wisconsin. A group of 150 African-American women, age 45 or above, completed a questionnaire about their risk factors for low bone density. In addition, they were asked to indicate what their perceived risk for osteoporosis was using a scale. Then they were given a bone density screening. Again, the results were not heartening. Only 25 percent of the African-American woman thought they were at risk for osteoporosis, but 33 percent of them had low bone mass, even at their relatively young age. The study published in a recent issue of the Wisconsin Medical Journal, points out the importance of educating African-American women about the risk factors for osteoporosis and how to prevent them.
Contact: Toranj Marphetia
toranjmcw.edu
Medical College of Wisconsin
"Over half of hip fracture patients never regain their prior level of functioning and 20 percent of them require nursing home care," according to Joan M. Neuner, M.D., M.P.H., lead author and assistant professor of medicine at the Medical College. Dr. Neuner is on the staff at Froedtert Hospital. "Women are very interested in preventing bone fractures. In an earlier study, 80 percent of women said they would "rather die" than enter a nursing home with a hip fracture."
Osteoporosis, in which the body breaks down bone faster than it is replaced, leading to lace-like, fragile bones, is a significant risk for older women. Nineteen percent of women in the age 65-74 group have it, 32.5 percent of women age 75-84, and over half of women over age 85.
The research team did a statistical analysis to see if older women are more or less likely to have the bone density test that would tell them their bone status. The retrospective study ??" one in which they looked at existing data to gain a new understanding ??" looked at the Medicare records of nearly 44,000 women from age 65 to 90 to see how many of them had a bone density test from 1999 (the first year Medicare paid for it) to 2001. They looked at the association between frequency of testing and the age of the women, controlling for factors such as socioeconomic class, race and other diseases they may have had.
"Since osteoporosis can be helped with appropriate therapy, it is especially important for older women to find out whether or not they need the therapy. Treatment with hormones or bone-building drugs can slow the process, rebuild some bone and reduce the risk of fracture by one-third," Dr. Neuner says.
The best scenario would be the oldest women being the most frequent subjects of bone density screenings. That did not prove to be the case. In fact, the research team found just the opposite. The older the age group, the fewer women had bone density tests.
The numbers were not heartening: 27 percent of women in the youngest age group, 65-70, had the test. At age 71-75, only 25.6 percent had it and; after age 75, the number fell to less than 10 percent.
Since this was a statistical study and no women were interviewed, the researchers could not determine the reason why older women failed to get the test. But they offer some possible reasons:
* Physicians not realizing the importance of bone density testing, or not being aware of how great women's life expectancy is ??" at age 80 most women can expect to live another nine years
* Physicians not being aware that osteoporosis treatment can reduce the risk of fracture in just three years
* Women having side effects from the treatment drugs or just not liking to take prescription medications
* Women not realizing that they are at risk, or mistakenly believing that osteoporosis is natural part of aging
The study points out the need for greater patient and physician education to convince women to get the testing they need, especially as they grow older and to determine if osteoporosis therapy would benefit them.
"Preventive care for older patients must be performed with an understanding of their life expectancy and values," Dr. Neuner says. "Osteoporosis screening may offer important opportunities to improve quality of life for many older patients."
The study was funded with a grant from National Institutes of Health. Other members of the research team were Neil Binkley, M.D., associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, Madison; Rodney A. Sparapani, M.S., Health Policy Institute biostatistician; Purushottam W. Laud, Ph.D., professor of the division of biostatistics at the Health Policy Institute; and Ann B. Nattinger, M.D., M.P.H., professor and chief of medicine and Lady Riders Professor of Breast Cancer Research.
Editor's Note:
In a related study, another group of Medical College researchers led by Srividya Kidambi, M.D., currently a fellow in endocrinology, looked at level of knowledge regarding the presence of osteoporosis in African-American women in Wisconsin. A group of 150 African-American women, age 45 or above, completed a questionnaire about their risk factors for low bone density. In addition, they were asked to indicate what their perceived risk for osteoporosis was using a scale. Then they were given a bone density screening. Again, the results were not heartening. Only 25 percent of the African-American woman thought they were at risk for osteoporosis, but 33 percent of them had low bone mass, even at their relatively young age. The study published in a recent issue of the Wisconsin Medical Journal, points out the importance of educating African-American women about the risk factors for osteoporosis and how to prevent them.
Contact: Toranj Marphetia
toranjmcw.edu
Medical College of Wisconsin
Life-Saving Heart Device Denied To Vulnerable Patients
Women who might have benefited from the use of an implantable heart monitor following a cardiac arrest were far less likely than men to have one prescribed, according to experts at the Duke University Medical Center.
Researchers looked at the records of more than 236,000 Medicare patients between 1999 and 2005 and found that the vast majority of patients who appeared to be eligible for an implantable cardioverter-defibrillator (ICD) didn't get one. But when ICDs were prescribed, men were two to three times more likely than women to receive them.
An ICD is a three-inch device that constantly monitors heart rhythms and uses electrical shocks to help control erratic rhythms that could cause the heart to stop beating.
"Clinical trials show that ICDs save lives, so the sex difference in treatment rates is worrisome," says lead author Lesley Curtis, a health services researcher and assistant professor in the Duke Clinical Research Institute (DCRI).
The findings appear in the October 3 issue of the Journal of the American Medical Association. A companion paper from Duke researchers in the same issue examines ICD use among patients in a subset of U.S. hospitals involved in the American Heart Association's heart failure quality improvement program, "Get With The Guidelines -- Heart Failure," and finds essentially the same thing.
"We don't know why the difference exists, but we do know that this is bad news for women," says senior author Kevin Schulman, M.D., an internist and health policy expert at DCRI.
Earlier studies revealing sex differences in ICD use were conducted before Medicare expanded its coverage for the devices, leaving open the possibility that the difference stemmed from income disparities between men and women. In the current study, the influence of income was reduced, because Medicare pays most of the cost of recommended ICDs.
"We found that the use of ICDs overall increased significantly over the study period, but in each year, the use among women lagged way behind that in men," Curtis says.
In addition, there appears to be a racial disparity. The data show that white men are more likely to get ICDs than black men, and white women are more likely to get them than black women.
The researchers say they do not know why ICD use should differ across sex and racial lines, but Curtis says one reason may be because physicians might perceive men to be at higher risk than women. In addition, she says there may be cultural or religious beliefs that may affect a patient's decision to have an ICD.
Schulman says it is discouraging to find such stark differences. "There is definitely an unconscious bias and there are definitely issues of access, but at the end of the day, I think it is about complexity. Our most vulnerable patients -- those who need care the most -- don't know how to navigate the system."
The study does have some limitations that may have affected the results. An important part of determining eligibility for ICD implantation in the primary prevention group is the heart's ejection fraction (EF), a measure of the heart's ability to pump. ICDs are recommended for people who have ejection fractions of 30 percent or less, but Curtis says women with heart failure are less likely than men to have low ejection fractions. Medicare records do not include that data, so it is possible that some of the women in the study who did not get an ICD were ineligible on that basis.
The study was funded by grants from the National Institute on Aging and the National Heart, Lung, and Blood Institute.
Study co-authors include Sana Al-Khatib, MD; Adrian Hernandez, MD; Alisa Shea, MPH; and Bradley Hammill, MS, all from the Duke Clinical Research Institute.
Several of the study authors, including Curtis and Schulman, have received financial support from pharmaceutical companies and device manufacturers that create products for heart failure care.
Source: Michelle Gailiun
Duke University Medical Center
Researchers looked at the records of more than 236,000 Medicare patients between 1999 and 2005 and found that the vast majority of patients who appeared to be eligible for an implantable cardioverter-defibrillator (ICD) didn't get one. But when ICDs were prescribed, men were two to three times more likely than women to receive them.
An ICD is a three-inch device that constantly monitors heart rhythms and uses electrical shocks to help control erratic rhythms that could cause the heart to stop beating.
"Clinical trials show that ICDs save lives, so the sex difference in treatment rates is worrisome," says lead author Lesley Curtis, a health services researcher and assistant professor in the Duke Clinical Research Institute (DCRI).
The findings appear in the October 3 issue of the Journal of the American Medical Association. A companion paper from Duke researchers in the same issue examines ICD use among patients in a subset of U.S. hospitals involved in the American Heart Association's heart failure quality improvement program, "Get With The Guidelines -- Heart Failure," and finds essentially the same thing.
"We don't know why the difference exists, but we do know that this is bad news for women," says senior author Kevin Schulman, M.D., an internist and health policy expert at DCRI.
Earlier studies revealing sex differences in ICD use were conducted before Medicare expanded its coverage for the devices, leaving open the possibility that the difference stemmed from income disparities between men and women. In the current study, the influence of income was reduced, because Medicare pays most of the cost of recommended ICDs.
"We found that the use of ICDs overall increased significantly over the study period, but in each year, the use among women lagged way behind that in men," Curtis says.
In addition, there appears to be a racial disparity. The data show that white men are more likely to get ICDs than black men, and white women are more likely to get them than black women.
The researchers say they do not know why ICD use should differ across sex and racial lines, but Curtis says one reason may be because physicians might perceive men to be at higher risk than women. In addition, she says there may be cultural or religious beliefs that may affect a patient's decision to have an ICD.
Schulman says it is discouraging to find such stark differences. "There is definitely an unconscious bias and there are definitely issues of access, but at the end of the day, I think it is about complexity. Our most vulnerable patients -- those who need care the most -- don't know how to navigate the system."
The study does have some limitations that may have affected the results. An important part of determining eligibility for ICD implantation in the primary prevention group is the heart's ejection fraction (EF), a measure of the heart's ability to pump. ICDs are recommended for people who have ejection fractions of 30 percent or less, but Curtis says women with heart failure are less likely than men to have low ejection fractions. Medicare records do not include that data, so it is possible that some of the women in the study who did not get an ICD were ineligible on that basis.
The study was funded by grants from the National Institute on Aging and the National Heart, Lung, and Blood Institute.
Study co-authors include Sana Al-Khatib, MD; Adrian Hernandez, MD; Alisa Shea, MPH; and Bradley Hammill, MS, all from the Duke Clinical Research Institute.
Several of the study authors, including Curtis and Schulman, have received financial support from pharmaceutical companies and device manufacturers that create products for heart failure care.
Source: Michelle Gailiun
Duke University Medical Center
Post-menopausal Women - Ultra Low-dose Estrogen Shown To Be Safe
Estradiol delivered via a skin patch over two years has no harmful effect on cognitive abilities or health-related quality of life.
A study led by researchers at the San Francisco VA Medical Center has shown that extremely low doses of estrogen had no ill effects on the cognitive abilities or general health of older women over the course of two years.
"This is exciting. It shows that women can take estrogen safely," observes lead author Kristine Yaffe, MD, chief of geriatric psychiatry at SFVAMC and associate professor of psychiatry, neurology, and epidemiology at the University of California, San Francisco.
In 2004, study results from the Women's Health Initiative (WHI), a nationwide longitudinal study sponsored by the National Institutes of Health, indicated that estrogen was associated with an increased risk of dementia among women 65 and older, as well as with an increased risk of heart attack and stroke.
"Those results raised a lot of doubts about whether women should be taking estrogen at all," Yaffe notes.
The current study, published in the July 2006 issue of Archives of Neurology, looked specifically at the potential effects of estrogen on cognitive abilities and quality of life. A group of 417 post-menopausal women aged 60 to 80 were randomly assigned to receive a daily .014 milligram dose of either estradiol, a form of estrogen, or a placebo through a skin patch for two years. The women were given a battery of standardized cognitive tests and a test of health-related quality of life at the beginning of the study, after one year, and after two years.
At the end of the study, there was no difference between the two groups in either cognitive abilities or health-related quality of life.
"The results are very reassuring, because it suggests that women can use this patch without harm for two years," says Yaffe. "It would benefit their bones and might have a beneficial effect in terms of hot flashes."
A related study of the same group of women showed a significant increase in bone density, without adverse health effects, in the women who took estradiol compared to the women who took placebo. The current study was a pre-planned secondary investigation.
Yaffe speculates that the differences in health and cognition outcomes between these two studies and the WHI studies could be related to three factors: dose, type of estrogen, and means of delivery.
The women in the WHI studies received .625 milligrams per day of conjugated estrogen - a mixture of estrogen from several different sources - in pill form. In contrast, the women studied by Yaffe and her associates received a daily dose of estradiol - pure human estrogen - that was over 44 times smaller and delivered through a skin patch.
"The different between a patch and a pill is significant because medications taken in pill form are processed through the liver before they reach the bloodstream," explains Yaffe. "It's thought that estrogen in pill form might stimulate the liver to produce substances that can lead to clotting or other adverse side effects. With a patch, you bypass the liver and go straight to the blood."
Yaffe notes that since the WHI results were announced in 2004, "the field of estrogen research has been stymied. Hopefully, this study will start to turn the tide."
Coauthors of the study are Eric Vittinghoff, PhD, of UCSF; Kristine E. Ensrud, MD, MPH, of the University of Minnesota and the Minneapolis VA Medical Center; Karen C. Johnson, MD, MPH, of the University of Tennessee Health Sciences Center; Susan Diem, MD, MPH, of UM; Vladmir Hanes, MD, of Berlex, Inc.; and Deborah Grady, MD, MPH, of SFVAMC and UCSF.
The research was funded by Berlex, Inc., with partial support from the National Institute of Aging.
SFVAMC has the largest medical research program in the national VA system, with more than 200 research scientists, all of whom are faculty members at UCSF.
UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.
Contact: Steve Tokar
University of California - San Francisco
View drug information on Estradiol Transdermal System.
A study led by researchers at the San Francisco VA Medical Center has shown that extremely low doses of estrogen had no ill effects on the cognitive abilities or general health of older women over the course of two years.
"This is exciting. It shows that women can take estrogen safely," observes lead author Kristine Yaffe, MD, chief of geriatric psychiatry at SFVAMC and associate professor of psychiatry, neurology, and epidemiology at the University of California, San Francisco.
In 2004, study results from the Women's Health Initiative (WHI), a nationwide longitudinal study sponsored by the National Institutes of Health, indicated that estrogen was associated with an increased risk of dementia among women 65 and older, as well as with an increased risk of heart attack and stroke.
"Those results raised a lot of doubts about whether women should be taking estrogen at all," Yaffe notes.
The current study, published in the July 2006 issue of Archives of Neurology, looked specifically at the potential effects of estrogen on cognitive abilities and quality of life. A group of 417 post-menopausal women aged 60 to 80 were randomly assigned to receive a daily .014 milligram dose of either estradiol, a form of estrogen, or a placebo through a skin patch for two years. The women were given a battery of standardized cognitive tests and a test of health-related quality of life at the beginning of the study, after one year, and after two years.
At the end of the study, there was no difference between the two groups in either cognitive abilities or health-related quality of life.
"The results are very reassuring, because it suggests that women can use this patch without harm for two years," says Yaffe. "It would benefit their bones and might have a beneficial effect in terms of hot flashes."
A related study of the same group of women showed a significant increase in bone density, without adverse health effects, in the women who took estradiol compared to the women who took placebo. The current study was a pre-planned secondary investigation.
Yaffe speculates that the differences in health and cognition outcomes between these two studies and the WHI studies could be related to three factors: dose, type of estrogen, and means of delivery.
The women in the WHI studies received .625 milligrams per day of conjugated estrogen - a mixture of estrogen from several different sources - in pill form. In contrast, the women studied by Yaffe and her associates received a daily dose of estradiol - pure human estrogen - that was over 44 times smaller and delivered through a skin patch.
"The different between a patch and a pill is significant because medications taken in pill form are processed through the liver before they reach the bloodstream," explains Yaffe. "It's thought that estrogen in pill form might stimulate the liver to produce substances that can lead to clotting or other adverse side effects. With a patch, you bypass the liver and go straight to the blood."
Yaffe notes that since the WHI results were announced in 2004, "the field of estrogen research has been stymied. Hopefully, this study will start to turn the tide."
Coauthors of the study are Eric Vittinghoff, PhD, of UCSF; Kristine E. Ensrud, MD, MPH, of the University of Minnesota and the Minneapolis VA Medical Center; Karen C. Johnson, MD, MPH, of the University of Tennessee Health Sciences Center; Susan Diem, MD, MPH, of UM; Vladmir Hanes, MD, of Berlex, Inc.; and Deborah Grady, MD, MPH, of SFVAMC and UCSF.
The research was funded by Berlex, Inc., with partial support from the National Institute of Aging.
SFVAMC has the largest medical research program in the national VA system, with more than 200 research scientists, all of whom are faculty members at UCSF.
UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.
Contact: Steve Tokar
University of California - San Francisco
View drug information on Estradiol Transdermal System.
Women's Unique Hypertension Issues Highlighted In Special Edition Of Journal Of The American Heart Association
Women face unique risks for developing hypertension and special challenges in keeping their high blood pressure under control, according to new research published in a special themed issue of Hypertension: Journal of the American Heart Association.
The themed issue features more than 45 studies and editorials related to women and hypertension. The publication commemorates the fifth anniversary of the launch of the American Heart Association's Go Red For Women movement, which raises awareness of heart disease risks for women.
"Our goals were to help convey the importance of prevention and treatment of hypertension and cardiovascular disease in women, to emphasize that hypertension is a critical cardiovascular risk factor in women, and to publish the newest and best research related to hypertension in women," said John E. Hall, Ph.D., Hypertension Editor-in-Chief, and Arthur C. Guyton Professor and Chair and Associate Vice Chancellor of Research at the University of Mississippi Medical Center in Jackson, Miss.
Data from the American Heart Association Heart Disease and Stroke Statistics - 2008 Update shows that high blood pressure kills significantly more women than men and is two to three times more common in women who take oral contraceptives than in women who don't.
In his preface to the journal, Hall cited previous studies that show only about 60 percent of hypertensive women are treated, and among those treated, only about a third had their blood pressure controlled at optimum levels. "Thus, inadequate control of high blood pressure continues to be the most important, and potentially treatable, cause of cardiovascular disease and stroke in women," he said.
"Through Go Red For Women the American Heart Association provides education and resources to help women live heart-healthy lives. More importantly, our movement puts a face on heart disease - the No. 1 killer of women," said Nieca Goldberg, M.D., Go Red For Women spokesperson, author and medical director of the New York University Women's Heart Program. "Our cause is based on science, such as the studies and perspectives we have gathered in this issue of Hypertension and the ongoing scientific research supported by the American Heart Association. This research is the foundation for the medical care doctors deliver in their offices. What we learn from this important body of science could one day save the life of someone's mother, wife, sister or daughter."
Here are highlights from the themed issue:
Dietary calcium, not supplements, may have a role in preventing hypertension
In a study of 28,888 non-hypertensive American women, age 45 or older, researchers found that the risk of hypertension:
* decreased with a higher intake of low-fat dietary calcium and dietary vitamin D,
* did not change with calcium or vitamin D supplements, and
* increased with high-fat dairy product intake.
Researchers tracked the intake of dairy products, calcium and vitamin D based on a 131-item food frequency questionnaire and conducted annual follow-up over a 10-year period. Nine possible responses ranging from "never or less than once per month" to "6+ per day" were recorded. During that time, 8,710 cases of hypertension were identified.
Contact: Lu Wang, M.D., Ph.D., Brigham and Women's Hospital, Boston, Mass.
Hypertension poses numerous risks for pregnancy
In a brief review accompanying several pregnancy-related studies in this issue, researchers note that hypertension is the most common medical disorder of pregnancy, complicating one in 10 pregnancies. They emphasize the importance of diagnosis in differentiating between pre-existing (chronic) hypertension and pregnancy-induced (gestational) hypertension and preeclampsia. They also support that pregnant women and those planning to become pregnant should avoid ACE inhibitors and angiotensin receptor blockers. Acceptable alternatives may include methyldopa, labetalol and nifedipine, in standard doses to manage hypertension in pregnancy.
Contact: Tiina Podymow, M.D., McGill University Health Center, Montreal, Quebec, Canada.
In a prospective study of 822 women with chronic hypertension, researchers in London identified 180 cases of preeclampsia (22 percent), with early onset preeclampsia accounting for nearly half of those. Of those women with preeclampsia, nearly half (48 percent) delivered small birthweight babies, while 51 percent of them delivered preterm, compared to 21 percent of women without preeclampsia having smaller babies and 15 percent of those women delivering preterm. According to the researchers, women with chronic hypertension should take special precautions before getting pregnant, including knowing their blood pressure, knowing of any family history of blood pressure problems during pregnancies, reducing their body mass index if it is elevated, quitting smoking and identifying any presence of renal disease.
Contact: Lucy Chappell, Ph.D., King's College, London School of Biomedical and Health Sciences, London, United Kingdom.
Researchers in the United Kingdom found that, while cigarette smoking in preeclamptic pregnancies further increases already present risks, stopping smoking can decrease the risks. A multicenter, cohort study of 1,001 white Western European women and their babies found that, compared to those who never smoke, the women who currently smoked in this study were more likely to deliver before 34 weeks, more likely to deliver lower birthweight babies or have babies with an adverse outcome (i. e., admission to a specialty unit, death), and were more likely to develop eclampsia. Women who had previously smoked and stopped prior to or during their pregnancy also significantly decreased their risks.
Of current smokers:
* 34.8 percent delivered before 34 weeks (compared to 26.8 percent of former smokers and 21.3 percent of non-smokers),
* 46.1 percent had low birthweight babies (compared to 37.5 percent of former smokers and 27.9 percent of non-smokers) and
* 65.6 percent had babies who experienced adverse outcomes (compared to 60 percent of former smokers and 50.4 percent of non-smokers).
Contact: Fiona Broughton-Pipkin, University of Nottingham, City Hospital, Nottingham, United Kingdom.
Gender plays a role in risk factors, treatment and control of hypertension
Two separate studies in the United States found persistent gender disparities in blood pressure control and cardiovascular disease management.
From the 1999-2004 National Health and Nutrition Examination Study, researchers analyzed data on 3,475 people, age 18 or older, diagnosed with hypertension. While blood pressure control in women and men was comparable (55.9 percent uncontrolled in women and 50.8 percent in men), the prevalence of central obesity, elevated total cholesterol level and low high-density lipoprotein-cholesterol were found to be significantly higher in women than in men. Those age adjusted risk factors included:
* central obesity (79 percent women vs. 63.9 percent men),
* elevated total cholesterol level (61.3 percent women vs. 48 percent men) and
* low high-density lipoprotein (LDL or "bad") cholesterol (39.7 women vs. 35.6 men.)
Contact: Bernard MY Cheung, Ph.D., University of Birmingham, Birmingham, United Kingdom.
Using data from the 2005 National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, researchers analyzed data from 12,064 patient visits (7,786 female, 4,275 male). They found that among patients with hypertension, women were less likely than men to:
* meet blood pressure control targets (54 percent vs. 58.7 percent),
* receive aspirin (20.7 percent vs. 35.5 percent),
* receive beta blockers (31.9 percent vs. 44.5 percent) or
* receive statins (28.5 percent vs. 35.3 percent) for secondary prevention of cardiovascular disease.
Less than half (20.7 percent of women, 46.6 percent of men) of all patients received recommended therapy across all conditions considered.
Contact: Salomeh Keyhani, M.D., M.P.H., Mount Sinai School of Medicine, New York, New York.
"This issue of Hypertension features the latest research from basic, clinical and population scientists," Hall said. "We hope it is helpful to clinicians and researchers, and that it helps to increase awareness of healthcare professionals and the public to the greatest threat to the health of women - hypertension and cardiovascular disease."
To view this issue of Hypertension, go to hyper.ahajournals/. To learn more about Go Red for Women, visit goredforwomen/.
Statements and conclusions of study authors that are published in the American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
Source: Cathy Lewis
American Heart Association
The themed issue features more than 45 studies and editorials related to women and hypertension. The publication commemorates the fifth anniversary of the launch of the American Heart Association's Go Red For Women movement, which raises awareness of heart disease risks for women.
"Our goals were to help convey the importance of prevention and treatment of hypertension and cardiovascular disease in women, to emphasize that hypertension is a critical cardiovascular risk factor in women, and to publish the newest and best research related to hypertension in women," said John E. Hall, Ph.D., Hypertension Editor-in-Chief, and Arthur C. Guyton Professor and Chair and Associate Vice Chancellor of Research at the University of Mississippi Medical Center in Jackson, Miss.
Data from the American Heart Association Heart Disease and Stroke Statistics - 2008 Update shows that high blood pressure kills significantly more women than men and is two to three times more common in women who take oral contraceptives than in women who don't.
In his preface to the journal, Hall cited previous studies that show only about 60 percent of hypertensive women are treated, and among those treated, only about a third had their blood pressure controlled at optimum levels. "Thus, inadequate control of high blood pressure continues to be the most important, and potentially treatable, cause of cardiovascular disease and stroke in women," he said.
"Through Go Red For Women the American Heart Association provides education and resources to help women live heart-healthy lives. More importantly, our movement puts a face on heart disease - the No. 1 killer of women," said Nieca Goldberg, M.D., Go Red For Women spokesperson, author and medical director of the New York University Women's Heart Program. "Our cause is based on science, such as the studies and perspectives we have gathered in this issue of Hypertension and the ongoing scientific research supported by the American Heart Association. This research is the foundation for the medical care doctors deliver in their offices. What we learn from this important body of science could one day save the life of someone's mother, wife, sister or daughter."
Here are highlights from the themed issue:
Dietary calcium, not supplements, may have a role in preventing hypertension
In a study of 28,888 non-hypertensive American women, age 45 or older, researchers found that the risk of hypertension:
* decreased with a higher intake of low-fat dietary calcium and dietary vitamin D,
* did not change with calcium or vitamin D supplements, and
* increased with high-fat dairy product intake.
Researchers tracked the intake of dairy products, calcium and vitamin D based on a 131-item food frequency questionnaire and conducted annual follow-up over a 10-year period. Nine possible responses ranging from "never or less than once per month" to "6+ per day" were recorded. During that time, 8,710 cases of hypertension were identified.
Contact: Lu Wang, M.D., Ph.D., Brigham and Women's Hospital, Boston, Mass.
Hypertension poses numerous risks for pregnancy
In a brief review accompanying several pregnancy-related studies in this issue, researchers note that hypertension is the most common medical disorder of pregnancy, complicating one in 10 pregnancies. They emphasize the importance of diagnosis in differentiating between pre-existing (chronic) hypertension and pregnancy-induced (gestational) hypertension and preeclampsia. They also support that pregnant women and those planning to become pregnant should avoid ACE inhibitors and angiotensin receptor blockers. Acceptable alternatives may include methyldopa, labetalol and nifedipine, in standard doses to manage hypertension in pregnancy.
Contact: Tiina Podymow, M.D., McGill University Health Center, Montreal, Quebec, Canada.
In a prospective study of 822 women with chronic hypertension, researchers in London identified 180 cases of preeclampsia (22 percent), with early onset preeclampsia accounting for nearly half of those. Of those women with preeclampsia, nearly half (48 percent) delivered small birthweight babies, while 51 percent of them delivered preterm, compared to 21 percent of women without preeclampsia having smaller babies and 15 percent of those women delivering preterm. According to the researchers, women with chronic hypertension should take special precautions before getting pregnant, including knowing their blood pressure, knowing of any family history of blood pressure problems during pregnancies, reducing their body mass index if it is elevated, quitting smoking and identifying any presence of renal disease.
Contact: Lucy Chappell, Ph.D., King's College, London School of Biomedical and Health Sciences, London, United Kingdom.
Researchers in the United Kingdom found that, while cigarette smoking in preeclamptic pregnancies further increases already present risks, stopping smoking can decrease the risks. A multicenter, cohort study of 1,001 white Western European women and their babies found that, compared to those who never smoke, the women who currently smoked in this study were more likely to deliver before 34 weeks, more likely to deliver lower birthweight babies or have babies with an adverse outcome (i. e., admission to a specialty unit, death), and were more likely to develop eclampsia. Women who had previously smoked and stopped prior to or during their pregnancy also significantly decreased their risks.
Of current smokers:
* 34.8 percent delivered before 34 weeks (compared to 26.8 percent of former smokers and 21.3 percent of non-smokers),
* 46.1 percent had low birthweight babies (compared to 37.5 percent of former smokers and 27.9 percent of non-smokers) and
* 65.6 percent had babies who experienced adverse outcomes (compared to 60 percent of former smokers and 50.4 percent of non-smokers).
Contact: Fiona Broughton-Pipkin, University of Nottingham, City Hospital, Nottingham, United Kingdom.
Gender plays a role in risk factors, treatment and control of hypertension
Two separate studies in the United States found persistent gender disparities in blood pressure control and cardiovascular disease management.
From the 1999-2004 National Health and Nutrition Examination Study, researchers analyzed data on 3,475 people, age 18 or older, diagnosed with hypertension. While blood pressure control in women and men was comparable (55.9 percent uncontrolled in women and 50.8 percent in men), the prevalence of central obesity, elevated total cholesterol level and low high-density lipoprotein-cholesterol were found to be significantly higher in women than in men. Those age adjusted risk factors included:
* central obesity (79 percent women vs. 63.9 percent men),
* elevated total cholesterol level (61.3 percent women vs. 48 percent men) and
* low high-density lipoprotein (LDL or "bad") cholesterol (39.7 women vs. 35.6 men.)
Contact: Bernard MY Cheung, Ph.D., University of Birmingham, Birmingham, United Kingdom.
Using data from the 2005 National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, researchers analyzed data from 12,064 patient visits (7,786 female, 4,275 male). They found that among patients with hypertension, women were less likely than men to:
* meet blood pressure control targets (54 percent vs. 58.7 percent),
* receive aspirin (20.7 percent vs. 35.5 percent),
* receive beta blockers (31.9 percent vs. 44.5 percent) or
* receive statins (28.5 percent vs. 35.3 percent) for secondary prevention of cardiovascular disease.
Less than half (20.7 percent of women, 46.6 percent of men) of all patients received recommended therapy across all conditions considered.
Contact: Salomeh Keyhani, M.D., M.P.H., Mount Sinai School of Medicine, New York, New York.
"This issue of Hypertension features the latest research from basic, clinical and population scientists," Hall said. "We hope it is helpful to clinicians and researchers, and that it helps to increase awareness of healthcare professionals and the public to the greatest threat to the health of women - hypertension and cardiovascular disease."
To view this issue of Hypertension, go to hyper.ahajournals/. To learn more about Go Red for Women, visit goredforwomen/.
Statements and conclusions of study authors that are published in the American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
Source: Cathy Lewis
American Heart Association
Young Women's Attitudes About Tanning Can Be Altered By Educational Materials And May Reduce Skin Cancer
A new study indicates that educational literature can influence young women's use of indoor tanning, not by raising their fear of skin cancer but by changing their attitudes about indoor tanning and promoting healthier alternatives for changing appearance. The study is published in the December 1, 2008 issue of CANCER, a peer-reviewed journal of the American Cancer Society.
Each year there are more than 1.3 million skin cancer diagnoses in the U.S., resulting in more than 10,000 deaths. A variety of efforts have attempted to get young people to alter their sun exposure behaviors, with limited success. For the new study, researchers led by Dr. Joel Hillhouse of the School of Public Health at East Tennessee State University designed a large, randomized, controlled study on an educational-based intervention meant to reduce indoor tanning, which is related to an increased risk of melanoma in young women.
The researchers included approximately 430 female university students aged 17 to 21 years, 200 of whom received a booklet on the effects of indoor tanning. The booklet, which focused on the appearance damaging effects of tanning, provided information on the history of tanning and tanning norms in society. It also presented the effects of ultraviolet radiation, specifically related to indoor tanning on the skin's appearance. The booklet also offered guidelines emphasizing tanning abstinence and recommended healthier alternatives to improve appearance including exercise, choosing fashion that does not require a complimentary tan and sunless tanning products.
All participants were assessed at the start of the study to determine their tanning practices over the previous year. Six months after the booklets were distributed, the subjects were asked questions related to recent indoor tanning frequency and their intentions to tan indoors in the future. The survey also explored attitudes toward indoor tanning, alternatives to indoor tanning, and beliefs about indoor tanning (e.g. whether it was relaxing or reduced stress). The test also assessed participants' thoughts on tanning's negative effects on physical appearance and risk of developing skin cancer.
The investigators found that indoor tanning was reduced by approximately 35 percent in women who received the booklets compared with women who received no intervention. Similar changes were noted for future intentions to tan. The intervention also reduced positive attitudes toward indoor tanning and improved attitudes toward using sunless tanning and fashion to enhance appearance. However, the investigators found no impact on participants' perceptions on susceptibility to skin damage or skin cancer from indoor tanning.
The study revealed that "a simple message delivery method, a booklet, was able to achieve clinically significant reductions in ultraviolet exposure behavior," the authors wrote. They concluded that their clinical trial "supports the use of??¦ intervention messages to change young people's ultraviolet risky behaviors and ultimately reduce skin cancer morbidity and mortality."
Article: "A randomized controlled trial of an appearance-focused intervention to prevent skin cancer." Joel Hillhouse, Rob Turrisi, Jerod Stapleton, and June Robinson. CANCER; Published Online: October 20, 2008 (DOI: 10.1002/cncr.23922); Print Issue Date: December 1, 2008.
Source: David Sampson
American Cancer Society
Each year there are more than 1.3 million skin cancer diagnoses in the U.S., resulting in more than 10,000 deaths. A variety of efforts have attempted to get young people to alter their sun exposure behaviors, with limited success. For the new study, researchers led by Dr. Joel Hillhouse of the School of Public Health at East Tennessee State University designed a large, randomized, controlled study on an educational-based intervention meant to reduce indoor tanning, which is related to an increased risk of melanoma in young women.
The researchers included approximately 430 female university students aged 17 to 21 years, 200 of whom received a booklet on the effects of indoor tanning. The booklet, which focused on the appearance damaging effects of tanning, provided information on the history of tanning and tanning norms in society. It also presented the effects of ultraviolet radiation, specifically related to indoor tanning on the skin's appearance. The booklet also offered guidelines emphasizing tanning abstinence and recommended healthier alternatives to improve appearance including exercise, choosing fashion that does not require a complimentary tan and sunless tanning products.
All participants were assessed at the start of the study to determine their tanning practices over the previous year. Six months after the booklets were distributed, the subjects were asked questions related to recent indoor tanning frequency and their intentions to tan indoors in the future. The survey also explored attitudes toward indoor tanning, alternatives to indoor tanning, and beliefs about indoor tanning (e.g. whether it was relaxing or reduced stress). The test also assessed participants' thoughts on tanning's negative effects on physical appearance and risk of developing skin cancer.
The investigators found that indoor tanning was reduced by approximately 35 percent in women who received the booklets compared with women who received no intervention. Similar changes were noted for future intentions to tan. The intervention also reduced positive attitudes toward indoor tanning and improved attitudes toward using sunless tanning and fashion to enhance appearance. However, the investigators found no impact on participants' perceptions on susceptibility to skin damage or skin cancer from indoor tanning.
The study revealed that "a simple message delivery method, a booklet, was able to achieve clinically significant reductions in ultraviolet exposure behavior," the authors wrote. They concluded that their clinical trial "supports the use of??¦ intervention messages to change young people's ultraviolet risky behaviors and ultimately reduce skin cancer morbidity and mortality."
Article: "A randomized controlled trial of an appearance-focused intervention to prevent skin cancer." Joel Hillhouse, Rob Turrisi, Jerod Stapleton, and June Robinson. CANCER; Published Online: October 20, 2008 (DOI: 10.1002/cncr.23922); Print Issue Date: December 1, 2008.
Source: David Sampson
American Cancer Society
AP/International Herald Tribune Examines Progress In Reducing Number Of African Infants Born With HIV
The AP/International Herald Tribune on Sunday examined how "after years of despair, Africa is making progress in protecting unborn [infants] from AIDS -- and in prolonging the life of the parents." According to a United Nations report titled "Children and AIDS" and published for World AIDS Day, the number of pregnant women receiving antiretrovirals in low- and middle-income countries has tripled in the past three years. In addition, increased donor interest and funding has made such gains even more impressive in some countries. Outgoing UNAIDS Executive Director Peter Piot, said, "The prevention of mother-to-child transmission of HIV is not only effective, but also a human right. We are seeing good progress in many countries, especially in parts of Africa, but we need to significantly scale up HIV testing and treatment for pregnant women."
The Cape Fertility Clinic in South Africa is the first such facility in Africa to open a laboratory for HIV-positive parents, enabling them to conceive and give birth to HIV-negative infants through procedures such as in vitro fertilization. Approximately five or six couples, with either one or both partners living with HIV/AIDS, visit the clinic every month, the AP/Herald Tribune reports. However, it adds that the clinic "is only for the favored few with enough money to pay for fertility treatment and is a drop in the ocean compared to the huge numbers of infected people."
Klaus Wiswedel, one of the clinic's directors, said, "HIV is no longer seen as a death sentence but a chronic disease. And people with chronic diseases are entitled to have fertility treatment. We can safely deliver an HIV-negative child and, with the right treatment, the parent can live a long life." According to Wiswedel, if the woman is HIV-positive and her husband is not, artificial insemination is used; if the man is HIV-positive, the sperm is cleansed of the virus. Once pregnant, the HIV-positive woman has to be followed by an HIV specialist and gives birth via caesarean section to reduce the chance of mother-to-child transmission (Nullis, AP/International Herald Tribune, 11/30).
The U.N. report is available online (.pdf).
The Cape Fertility Clinic in South Africa is the first such facility in Africa to open a laboratory for HIV-positive parents, enabling them to conceive and give birth to HIV-negative infants through procedures such as in vitro fertilization. Approximately five or six couples, with either one or both partners living with HIV/AIDS, visit the clinic every month, the AP/Herald Tribune reports. However, it adds that the clinic "is only for the favored few with enough money to pay for fertility treatment and is a drop in the ocean compared to the huge numbers of infected people."
Klaus Wiswedel, one of the clinic's directors, said, "HIV is no longer seen as a death sentence but a chronic disease. And people with chronic diseases are entitled to have fertility treatment. We can safely deliver an HIV-negative child and, with the right treatment, the parent can live a long life." According to Wiswedel, if the woman is HIV-positive and her husband is not, artificial insemination is used; if the man is HIV-positive, the sperm is cleansed of the virus. Once pregnant, the HIV-positive woman has to be followed by an HIV specialist and gives birth via caesarean section to reduce the chance of mother-to-child transmission (Nullis, AP/International Herald Tribune, 11/30).
The U.N. report is available online (.pdf).
Christian Science Monitor Examines HIV Prevention in Africa
In related news, the Christian Science Monitor on Monday examined a "revolutionary new generation of AIDS prevention campaigns that reflect a growing recognition that condoms aren't enough and that slowing the epidemic will require widespread cultural change." According to the Monitor, the campaigns are "based on new research about the driving forces of the epidemic -- specifically the common practice in many hard-hit African countries of having multiple, long-term sexual partners at the same time." However, the new messages "are also blurring the often-rancorous divide between largely secular advocates of condom-based messages and religious organizations that emphasize abstinence and fidelity," the Monitor reports. According to the Monitor, these efforts are "boosting enthusiasm for HIV/AIDS prevention efforts" (Itano, Christian Science Monitor, 12/1).
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.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Differences Among Exercisers And Non Exercisers During Pregnancy
No one doubts that mothers especially pregnant mothers are among the busiest people on earth. And while the benefits of exercise for these women and their developing fetuses are widely known, many expectant mothers do not exercise. A survey examining daily activities of moms-to-be will soon be released as part of a larger study looking at the effect of maternal exercise on fetal development. The results suggest, among other things, that exercising during pregnancy does not require "stealing" time from other activities.
The study was conducted by Linda E. May, Kansas City University of Medicine and Biosciences (KCUMB), Kansas City, MO; Alan Glaros, KCUMB, and Kathleen M. Gustafson, University of Kansas Medical Center, Kansas City, KS and is entitled Differences Among Exercisers and Non-Exercisers During Pregnancy. The team will discuss its study at the 122nd Annual Meeting of the American Physiological Society, which is part of the Experimental Biology 2009 scientific conference. The meeting will be held April 18-22, 2009 in New Orleans.
The Study and Background
Based on previous research findings, over one-third (36 percent) of pregnant moms cite time as the main reason for not participating in regular aerobic exercise. With this in mind, the researchers wanted to determine if women who exercised during pregnancy spent less time doing specific activities in order to have time for exercise and to determine if there were any trends between mothers who exercised during pregnancy and those that do not.
A highly reliable and validated Modifiable Activity Questionnaire (MAQ) was used to survey pregnant mothers. Survey questions pertained to daily activities (i.e., employment, exercise, amount of sleep) and demographics.
Researchers analyzed the results from thirty-eight pregnant mothers (21 exercisers and 17 non-exercisers). All women were healthy, non-smokers between 23 and 39 years of age. The sample population includes women with various education levels, employed in and out of the home, and who live in the Kansas City metro area. Exercisers participated in moderate or vigorous aerobic activity at least 30 minutes three times per week throughout the pregnancy. Control mothers did not.
Results
There were no differences between groups based on maternal age, education levels, employment, number of children, fetal gender, and even maternal height. Although these groups were similar in many ways, there were significant differences between groups and trends as well:
-- Although the most common reason for not exercising during pregnancy is 'lack of time,' 85% of control women spent more than 1 hour at the TV or computer and 77% spent more than 1 hour read/writing/studying.
-- There was a trend for the exercisers to have slightly more sleep and reading time.
-- There was a trend for non-exercisers to have slightly more TV/computer time.
-- BMI and maternal pre-pregnancy weight was significantly lower in the exercisers. Additionally, women with more education had lower BMIs, in general for both groups.
-- For non-exercising pregnant women, employment was a factor in maternal weight and BMI, such that those who were worked outside of the home had lower BMIs.
Conclusion
The researchers theorize that pregnant mothers who exercise may manage their time more effectively than non-exercisers. Because exercisers sleep and read slightly more than non-exercisers and spend slightly less time on the computer, researchers conclude that exercisers are simply more likely to fit exercise into their day. Non-exercisers may suffer from a perception that they lack time to exercise, when they need to manage their time differently to fit more physical activity into their day.
According to Dr. May, "if a pregnant mother does some type of physical activity while watching TV or talking on the phone, or parks her car at the farthest point from the store each time, she will increase her daily physical activity and ultimately improve her health and the health of her baby." Such a small step can provide benefits to mom and the fetus, and take no extra time from the daily routine."
Physiology is the study of how molecules, cells, tissues and organs function to create health or disease. The American Physiological Society has been an integral part of this discovery process since it was established in 1887.
Source: American Physiological Society (APS)
The study was conducted by Linda E. May, Kansas City University of Medicine and Biosciences (KCUMB), Kansas City, MO; Alan Glaros, KCUMB, and Kathleen M. Gustafson, University of Kansas Medical Center, Kansas City, KS and is entitled Differences Among Exercisers and Non-Exercisers During Pregnancy. The team will discuss its study at the 122nd Annual Meeting of the American Physiological Society, which is part of the Experimental Biology 2009 scientific conference. The meeting will be held April 18-22, 2009 in New Orleans.
The Study and Background
Based on previous research findings, over one-third (36 percent) of pregnant moms cite time as the main reason for not participating in regular aerobic exercise. With this in mind, the researchers wanted to determine if women who exercised during pregnancy spent less time doing specific activities in order to have time for exercise and to determine if there were any trends between mothers who exercised during pregnancy and those that do not.
A highly reliable and validated Modifiable Activity Questionnaire (MAQ) was used to survey pregnant mothers. Survey questions pertained to daily activities (i.e., employment, exercise, amount of sleep) and demographics.
Researchers analyzed the results from thirty-eight pregnant mothers (21 exercisers and 17 non-exercisers). All women were healthy, non-smokers between 23 and 39 years of age. The sample population includes women with various education levels, employed in and out of the home, and who live in the Kansas City metro area. Exercisers participated in moderate or vigorous aerobic activity at least 30 minutes three times per week throughout the pregnancy. Control mothers did not.
Results
There were no differences between groups based on maternal age, education levels, employment, number of children, fetal gender, and even maternal height. Although these groups were similar in many ways, there were significant differences between groups and trends as well:
-- Although the most common reason for not exercising during pregnancy is 'lack of time,' 85% of control women spent more than 1 hour at the TV or computer and 77% spent more than 1 hour read/writing/studying.
-- There was a trend for the exercisers to have slightly more sleep and reading time.
-- There was a trend for non-exercisers to have slightly more TV/computer time.
-- BMI and maternal pre-pregnancy weight was significantly lower in the exercisers. Additionally, women with more education had lower BMIs, in general for both groups.
-- For non-exercising pregnant women, employment was a factor in maternal weight and BMI, such that those who were worked outside of the home had lower BMIs.
Conclusion
The researchers theorize that pregnant mothers who exercise may manage their time more effectively than non-exercisers. Because exercisers sleep and read slightly more than non-exercisers and spend slightly less time on the computer, researchers conclude that exercisers are simply more likely to fit exercise into their day. Non-exercisers may suffer from a perception that they lack time to exercise, when they need to manage their time differently to fit more physical activity into their day.
According to Dr. May, "if a pregnant mother does some type of physical activity while watching TV or talking on the phone, or parks her car at the farthest point from the store each time, she will increase her daily physical activity and ultimately improve her health and the health of her baby." Such a small step can provide benefits to mom and the fetus, and take no extra time from the daily routine."
Physiology is the study of how molecules, cells, tissues and organs function to create health or disease. The American Physiological Society has been an integral part of this discovery process since it was established in 1887.
Source: American Physiological Society (APS)
Vaginal hysterectomy leads to better outcomes than abdominal surgery
A review of recent studies concludes that surgeons should perform vaginal rather than abdominal hysterectomies whenever
possible in order to cut down on complications and the length of hospital stays.1
According to the systematic evidence review by Dr. Neil Johnson of the University of Auckland in New Zealand and colleagues,
women who had vaginal hysterectomies had fewer infections and high temperatures after surgery compared to those who had
abdominal hysterectomies.
Women with vaginal hysterectomies also returned to their normal activities quicker than those who had the abdominal surgery,
the researchers found.
The better outcomes associated with vaginal hysterectomy suggest it "should be performed in preference to abdominal
hysterectomy where possible," Johnson says.
But "the surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the
relative benefits and hazards," he adds.
The review appears in the January issue of The Cochrane Library, a publication of The Cochrane Collaboration, an
international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical
practice after considering both the content and quality of existing medical trials on a topic.
In a vaginal hysterectomy, surgeons remove the uterus through the vaginal opening. Vaginal hysterectomies are usually
performed when the uterus is a normal size. Abdominal hysterectomies, where the uterus is removed through an abdominal
opening, has traditionally been used when a woman has an enlarged uterus, malignant tumors or conditions such as
endometriosis.
The Cochrane researchers also reviewed the evidence comparing laparoscopic and abdominal hysterectomy. In laparoscopic
hysterectomies, the uterus is removed with the help of specialized instruments and a small fiber optic camera inserted
through a small incision in the abdomen. Some laparoscopic hysterectomies also include a vaginal surgical component.
Johnson and colleagues concluded that the laparoscopic procedure had some of the same advantages as vaginal hysterectomies,
such as shorter hospital stays and fewer complications like infection.
They also noted, however, that laparoscopic hysterectomies are longer operations than abdominal or vaginal hysterectomies and
may carry a greater risk of damaging the bladder or ureter, the tube that leads from the kidney to the bladder.
"There were conflicting data on which was the quickest operation to perform and this presumably relates to the prior
experience with these procedures of the surgeons involved in the trials," Johnson says.
None of the studies reported a significant cost difference between laparoscopic and abdominal hysterectomies, but one study
found that laparoscopic hysterectomies were significantly more costly than vaginal hysterectomies.
The Cochrane researchers reviewed data from 27 studies that included 3,643 women, most of whom were between age 41 and 50.
Each of the studies included in the analysis was a randomized controlled trial directly comparing one type of hysterectomy
with another.
"The introduction of the newer techniques of laparoscopic hysterectomy has, we feel, made us all look more critically, not
only at the newer approaches, but indeed at all approaches to hysterectomy," Johnson says.
According to a 2002 report by the Centers for Disease Control and Prevention, hysterectomy is the second most frequently
performed surgery, after caesarean section, for women of reproductive age. About 600,000 hysterectomies are performed each
year in the United States. More than 60 percent of hysterectomies performed between 1994 and 1999 were abdominal, according
to the CDC report.
Johnson says the percentage of hysterectomies performed by each of the surgical approaches "varies markedly across countries,
within the same country and even between individual surgeons working within the same unit."
Lower rates of vaginal hysterectomy do not necessarily mean that the technique is being avoided, but rather underutilized,
Johnson says, "perhaps because some gynecologists have had insufficient training in the vaginal approach to hysterectomy."
Amanda Hall, a spokesperson for the American College of Gynecologists, says the organization has no official recommendation.
"It's really a case-by-case basis," she says.
According to the 2002 CDC study, rates of laparoscopy-assisted vaginal hysterectomies more than doubled between 1994 and
1999, from 13 percent of all vaginal hysterectomies to 28 percent.
"Where vaginal hysterectomy is not possible, a laparoscopic approach may avoid the need for an abdominal hysterectomy,"
Johnson says, but he stresses that more research on laparascopic techniques is needed.
Johnson says future studies comparing hysterectomy type should focus on long-term effects, such as urinary and sexual
dysfunction and the formation of fistulas, holes in the vagina, bladder or rectum that often lead to incontinence.
by Becky Ham, Science Writer Health Behavior News Service
FOR MORE INFORMATION
Health Behavior News Service: 202-387-2829 or www.hbns.
Interviews: Contact Neil Johnson, 64-9-373-7599 ext. 89488, n.johnsonauckland.ac.nz
1. Johnson et al. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Database of Systematic
Reviews 2005, Issue 1
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic
reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of
interventions. Visit cochrane for more information.
Contact: Neil Johnson
n.johnsonauckland.ac.nz
Center for the Advancement of Health
possible in order to cut down on complications and the length of hospital stays.1
According to the systematic evidence review by Dr. Neil Johnson of the University of Auckland in New Zealand and colleagues,
women who had vaginal hysterectomies had fewer infections and high temperatures after surgery compared to those who had
abdominal hysterectomies.
Women with vaginal hysterectomies also returned to their normal activities quicker than those who had the abdominal surgery,
the researchers found.
The better outcomes associated with vaginal hysterectomy suggest it "should be performed in preference to abdominal
hysterectomy where possible," Johnson says.
But "the surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the
relative benefits and hazards," he adds.
The review appears in the January issue of The Cochrane Library, a publication of The Cochrane Collaboration, an
international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical
practice after considering both the content and quality of existing medical trials on a topic.
In a vaginal hysterectomy, surgeons remove the uterus through the vaginal opening. Vaginal hysterectomies are usually
performed when the uterus is a normal size. Abdominal hysterectomies, where the uterus is removed through an abdominal
opening, has traditionally been used when a woman has an enlarged uterus, malignant tumors or conditions such as
endometriosis.
The Cochrane researchers also reviewed the evidence comparing laparoscopic and abdominal hysterectomy. In laparoscopic
hysterectomies, the uterus is removed with the help of specialized instruments and a small fiber optic camera inserted
through a small incision in the abdomen. Some laparoscopic hysterectomies also include a vaginal surgical component.
Johnson and colleagues concluded that the laparoscopic procedure had some of the same advantages as vaginal hysterectomies,
such as shorter hospital stays and fewer complications like infection.
They also noted, however, that laparoscopic hysterectomies are longer operations than abdominal or vaginal hysterectomies and
may carry a greater risk of damaging the bladder or ureter, the tube that leads from the kidney to the bladder.
"There were conflicting data on which was the quickest operation to perform and this presumably relates to the prior
experience with these procedures of the surgeons involved in the trials," Johnson says.
None of the studies reported a significant cost difference between laparoscopic and abdominal hysterectomies, but one study
found that laparoscopic hysterectomies were significantly more costly than vaginal hysterectomies.
The Cochrane researchers reviewed data from 27 studies that included 3,643 women, most of whom were between age 41 and 50.
Each of the studies included in the analysis was a randomized controlled trial directly comparing one type of hysterectomy
with another.
"The introduction of the newer techniques of laparoscopic hysterectomy has, we feel, made us all look more critically, not
only at the newer approaches, but indeed at all approaches to hysterectomy," Johnson says.
According to a 2002 report by the Centers for Disease Control and Prevention, hysterectomy is the second most frequently
performed surgery, after caesarean section, for women of reproductive age. About 600,000 hysterectomies are performed each
year in the United States. More than 60 percent of hysterectomies performed between 1994 and 1999 were abdominal, according
to the CDC report.
Johnson says the percentage of hysterectomies performed by each of the surgical approaches "varies markedly across countries,
within the same country and even between individual surgeons working within the same unit."
Lower rates of vaginal hysterectomy do not necessarily mean that the technique is being avoided, but rather underutilized,
Johnson says, "perhaps because some gynecologists have had insufficient training in the vaginal approach to hysterectomy."
Amanda Hall, a spokesperson for the American College of Gynecologists, says the organization has no official recommendation.
"It's really a case-by-case basis," she says.
According to the 2002 CDC study, rates of laparoscopy-assisted vaginal hysterectomies more than doubled between 1994 and
1999, from 13 percent of all vaginal hysterectomies to 28 percent.
"Where vaginal hysterectomy is not possible, a laparoscopic approach may avoid the need for an abdominal hysterectomy,"
Johnson says, but he stresses that more research on laparascopic techniques is needed.
Johnson says future studies comparing hysterectomy type should focus on long-term effects, such as urinary and sexual
dysfunction and the formation of fistulas, holes in the vagina, bladder or rectum that often lead to incontinence.
by Becky Ham, Science Writer Health Behavior News Service
FOR MORE INFORMATION
Health Behavior News Service: 202-387-2829 or www.hbns.
Interviews: Contact Neil Johnson, 64-9-373-7599 ext. 89488, n.johnsonauckland.ac.nz
1. Johnson et al. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Database of Systematic
Reviews 2005, Issue 1
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic
reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of
interventions. Visit cochrane for more information.
Contact: Neil Johnson
n.johnsonauckland.ac.nz
Center for the Advancement of Health
Genentech Announces Positive Results From A Randomized Phase II Study Of Pertuzumab In Combination With Gemcitabine For Advanced Ovarian Cancer
Genentech, Inc. (NYSE: DNA) today announced encouraging results from a
randomized Phase II study comparing pertuzumab plus gemcitabine to
gemcitabine alone in women with platinum-resistant ovarian, primary
peritoneal, or fallopian tube cancer. Data from the study will be submitted
for presentation at an upcoming medical meeting.
Pertuzumab or 2C4, a humanized antibody formerly known as Omnitarg, is
the first in a new class of investigational agents known as HER
dimerization inhibitors (HDIs). Pertuzumab is designed to bind to the HER2
receptor - a protein found on the surface of epithelial cells - and inhibit
the ability of HER2 to interact with other HER family receptors (HER1,
HER2, HER3, and HER4). HER dimerization (pairing) is believed to play an
important role in the growth and formation of several different cancer
types.
"Advanced ovarian cancer continues to be a difficult-to-treat cancer
with few approved treatment options," said Hal Barron, Genentech senior
vice president, Development and chief medical officer. "We are encouraged
by the results of this trial, and will continue to analyze the data to help
determine next steps for the pertuzumab development program."
In this study, no new or unexpected safety signals were observed.
Adverse events were similar to those observed in previous clinical trials
of pertuzumab and included fatigue, diarrhea, back pain, and neutropenia.
The cardiac safety profile in the pertuzumab arm was similar to that of the
gemcitabine-alone arm; there was one congestive heart failure event
reported in the pertuzumab arm. More detailed information about adverse
events will be available when the data are presented.
About the Study
In this Phase II, placebo-controlled, double-blinded, multi-center
study, 130 women with advanced ovarian, primary peritoneal, or fallopian
tube cancer were enrolled and received treatment with pertuzumab plus
gemcitabine, or gemcitabine alone. Eligible patients must have experienced
disease progression within six months of receiving a platinum-based
chemotherapy regimen that did not contain gemcitabine or any other HER
receptor targeting agent. Patients who had received more than one prior
chemotherapy regimen for platinum-resistant disease, or more than one
non-platinum-containing regimen for platinum-sensitive disease, were
excluded from the study. The primary endpoint of the study was
progression-free survival. Exploratory diagnostic marker data to help
evaluate if HER2 receptor activation may be a predictor of clinical
response were collected as part of this trial, and are currently being
analyzed.
About Pertuzumab
Pertuzumab is a humanized monoclonal antibody designed to bind to the
HER2 receptor and inhibit the ability of HER2 to interact with other HER
family members (HER1, HER2, HER3, and HER4). The HER signaling pathway
plays a role in the formation and growth of numerous cancers, and previous
clinical trials of pertuzumab in a single agent setting had suggested
clinical activity - including stable disease - in heavily pretreated
patients with advanced ovarian and breast cancers. Genentech and Roche are
evaluating pertuzumab in solid tumors (ovarian and breast cancers), and in
combination with other therapies. Diagnostic analyses to evaluate if HER2
receptor activation may be a predictor of clinical response, with the goal
of helping oncologists select patients most likely to respond to
pertuzumab, are a component of all ongoing pertuzumab clinical trials.
About Ovarian Cancer
The American Cancer Society (ACS) estimates that in 2006, approximately
20,180 women will have been diagnosed with ovarian cancer and 15,310 will
have died of the disease. Ovarian cancer is the eighth most common cancer
among women, and is the fifth most common cause of cancer death among
women. According to the ACS, fallopian tube cancer and primary peritoneal
cancers often are grouped with the ovarian cancer category of tumors, as
symptoms and treatment are similar.
About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by
establishing a broad oncology portfolio of innovative, targeted therapies
with the goal of improving patients' lives. The company is the leading
provider of anti-tumor therapeutics in the United States. Genentech is
conducting clinical development programs for Rituxan(R) (Rituximab),
Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab), and Tarceva(R)
(erlotinib), and markets all four products in the United States, either
alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan), or OSI
Pharmaceuticals, Inc. (Tarceva).
The company has a robust pipeline of potential oncology therapies with
a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell
death), the HER pathway, and B-cell biology. An investigational antibody
directed at the HER pathway is currently in Phase II trials. In early
development, are a small molecule directed at the hedgehog pathway and an
investigational agent targeting apoptosis.
Founded 30 years ago, Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the currently
approved biotechnology products originated from, or are based on, Genentech
science. Genentech manufactures and commercializes multiple biotechnology
products and licenses several additional products to other companies. The
company has headquarters in South San Francisco, Calif., and is listed on
the New York Stock Exchange under the symbol DNA. For additional
information about the company, please visit gene/.
Genentech, Inc.
gene/
View drug information on Avastin; Herceptin; Rituxan.
randomized Phase II study comparing pertuzumab plus gemcitabine to
gemcitabine alone in women with platinum-resistant ovarian, primary
peritoneal, or fallopian tube cancer. Data from the study will be submitted
for presentation at an upcoming medical meeting.
Pertuzumab or 2C4, a humanized antibody formerly known as Omnitarg, is
the first in a new class of investigational agents known as HER
dimerization inhibitors (HDIs). Pertuzumab is designed to bind to the HER2
receptor - a protein found on the surface of epithelial cells - and inhibit
the ability of HER2 to interact with other HER family receptors (HER1,
HER2, HER3, and HER4). HER dimerization (pairing) is believed to play an
important role in the growth and formation of several different cancer
types.
"Advanced ovarian cancer continues to be a difficult-to-treat cancer
with few approved treatment options," said Hal Barron, Genentech senior
vice president, Development and chief medical officer. "We are encouraged
by the results of this trial, and will continue to analyze the data to help
determine next steps for the pertuzumab development program."
In this study, no new or unexpected safety signals were observed.
Adverse events were similar to those observed in previous clinical trials
of pertuzumab and included fatigue, diarrhea, back pain, and neutropenia.
The cardiac safety profile in the pertuzumab arm was similar to that of the
gemcitabine-alone arm; there was one congestive heart failure event
reported in the pertuzumab arm. More detailed information about adverse
events will be available when the data are presented.
About the Study
In this Phase II, placebo-controlled, double-blinded, multi-center
study, 130 women with advanced ovarian, primary peritoneal, or fallopian
tube cancer were enrolled and received treatment with pertuzumab plus
gemcitabine, or gemcitabine alone. Eligible patients must have experienced
disease progression within six months of receiving a platinum-based
chemotherapy regimen that did not contain gemcitabine or any other HER
receptor targeting agent. Patients who had received more than one prior
chemotherapy regimen for platinum-resistant disease, or more than one
non-platinum-containing regimen for platinum-sensitive disease, were
excluded from the study. The primary endpoint of the study was
progression-free survival. Exploratory diagnostic marker data to help
evaluate if HER2 receptor activation may be a predictor of clinical
response were collected as part of this trial, and are currently being
analyzed.
About Pertuzumab
Pertuzumab is a humanized monoclonal antibody designed to bind to the
HER2 receptor and inhibit the ability of HER2 to interact with other HER
family members (HER1, HER2, HER3, and HER4). The HER signaling pathway
plays a role in the formation and growth of numerous cancers, and previous
clinical trials of pertuzumab in a single agent setting had suggested
clinical activity - including stable disease - in heavily pretreated
patients with advanced ovarian and breast cancers. Genentech and Roche are
evaluating pertuzumab in solid tumors (ovarian and breast cancers), and in
combination with other therapies. Diagnostic analyses to evaluate if HER2
receptor activation may be a predictor of clinical response, with the goal
of helping oncologists select patients most likely to respond to
pertuzumab, are a component of all ongoing pertuzumab clinical trials.
About Ovarian Cancer
The American Cancer Society (ACS) estimates that in 2006, approximately
20,180 women will have been diagnosed with ovarian cancer and 15,310 will
have died of the disease. Ovarian cancer is the eighth most common cancer
among women, and is the fifth most common cause of cancer death among
women. According to the ACS, fallopian tube cancer and primary peritoneal
cancers often are grouped with the ovarian cancer category of tumors, as
symptoms and treatment are similar.
About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by
establishing a broad oncology portfolio of innovative, targeted therapies
with the goal of improving patients' lives. The company is the leading
provider of anti-tumor therapeutics in the United States. Genentech is
conducting clinical development programs for Rituxan(R) (Rituximab),
Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab), and Tarceva(R)
(erlotinib), and markets all four products in the United States, either
alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan), or OSI
Pharmaceuticals, Inc. (Tarceva).
The company has a robust pipeline of potential oncology therapies with
a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell
death), the HER pathway, and B-cell biology. An investigational antibody
directed at the HER pathway is currently in Phase II trials. In early
development, are a small molecule directed at the hedgehog pathway and an
investigational agent targeting apoptosis.
Founded 30 years ago, Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the currently
approved biotechnology products originated from, or are based on, Genentech
science. Genentech manufactures and commercializes multiple biotechnology
products and licenses several additional products to other companies. The
company has headquarters in South San Francisco, Calif., and is listed on
the New York Stock Exchange under the symbol DNA. For additional
information about the company, please visit gene/.
Genentech, Inc.
gene/
View drug information on Avastin; Herceptin; Rituxan.
Videos Comment On Health Reform, Roe V. Wade Anniversary
The following summarizes select women's health-related videos.
Re-debating Reform: For House Republican leaders, this week's vote on a health care reform repeal bill was a top priority, but the debate also gave Democrats a platform to rehash the law's merits. MSNBC's Rachel Maddow recaps Democrats' rebuttals of GOP talking points and interviews House Minority Leader Nancy Pelosi (D-Calif.) about the politicking behind Wednesday's vote (Maddow, "The Rachel Maddow Show," MSNBC, 1/19). The full interview with Pelosi also is available online.
Remembering Roe: Check out this Jan. 22, 1973 video from the ABC News archives for a historical perspective on Sunday's 38th anniversary of the Roe v. Wade decision legalizing abortion. The broadcast includes a report on a New York state case and comments from women who had abortion procedures before Roe (ABC News, 1/20).
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.
FDA Asks Wyeth To Submit More Data On Oral Contraceptive That Stops Menstrual Bleeding, Company Says
Wyeth on Wednesday said it has received an "approvable" letter from FDA for its oral contraceptive pill Lybrel, which can eliminate women's monthly periods if taken consistently throughout the year, the Wall Street Journal reports. The letter indicates that the agency might approve the product but only after receiving more data on it, according to the Journal (Wall Street Journal, 6/29). Lybrel, which contains a lower dose of synthetic hormones in a daily dose than traditional oral contraceptives, is taken 365 days a year with no placebo pills. The usual regimen for oral contraceptives is 21 active pills taken consecutively, followed by seven placebo pills. During the week of placebo pills, women bleed and experience other menstrual symptoms. The period women experience during the week of placebo pills is a "withdrawal bleed," which is not necessarily the same as normal menstrual bleeding. According to Wyeth, Lybrel stopped 71% of women's bleeding after seven months. One study shows that almost all women who took the drug began experiencing their periods within three months of terminating its use (Kaiser Daily Women's Health Policy Report, 5/24).
Data Sought
According to the company, FDA is seeking packaging information and "stability" data that demonstrates whether the pill is able to remain on pharmacy shelves or in medicine cabinets for an extensive period of time without denaturing (Wall Street Journal, 6/29). Wyeth also must provide additional data from clinical trials on pregnancy rates, bleeding patterns and the discontinuation rates of participants enrolled in the trials, according to FDA (AP/San Diego Union-Tribune, 6/28). Amy Marren, a physician in Wyeth's global medical affairs division, said that "in some fashion, ... FDA intends to discuss" bleeding patterns among the women taking Lybrel, adding that the number of women taking Lybrel who stopped menstrual bleeding increased over time, though some women continued to experience bleeding or spotting. Marren also said that it is unclear why the agency wanted to review how many women stopped taking Lybrel during the trial (Dow Jones Newswires, 6/28). Wyeth said it is confident that it can answer the questions posed by FDA (Reuters, 6/29). FDA officials could not be reached for comment, according to Dow Jones Newswires (Dow Jones Newswires, 6/28).
More Than 80% of Women Taking Experimental Oral Contraceptive Eliminated Menstrual Bleeding, Study Says
More than 80% of women who took Wyeth's experimental oral contraceptive Anya, which can eliminate periods, reported total menstrual bleeding suppression after two years of regular use, according to a study presented on Monday at the Society of Obstetricians and Gynecologists of Canada's 62nd Annual Clinical Meeting in Vancouver, Canada, Toronto's Globe and Mail reports. Robert Reid, an ob-gyn professor at Queen's University, and colleagues examined 79 women who took Anya, which has not been approved by Canada's national health agency Health Canada. The drug has a lower dose of hormones than traditional birth control pills, according to the Globe and Mail. The researchers found that about 5% of the women enrolled in the study reported spotting or bleeding, and the pills had similar side effects to those of other oral contraceptives. Christine Derzko, an ob-gyn at St. Michael's Hospital in Toronto, said bleeding is not a physiological necessity for women taking oral contraceptives, and bleeding for some women can lead to "very serious medical (side effects)." However, Christine Hitchcock, a research associate at the Centre for Menstrual Cycle Ovulation Research at the University of British Columbia, said that the "lack of a break from hormonal stimulation" when taking oral contraceptives that can eliminate periods "is potentially a problem, not the lack of menstrual bleeding that occurs during the pill-free interval." She said that use of oral contraceptives could increase risk of developing cervical cancer, adding, "[N]obody's looked at the effects on breasts, nobody's looked at the effects on teenage development, breast density, bone density." According to the Globe and Mail, Health Canada and Wyeth are discussing studies to follow up with women taking Anya every six months to screen for any long-term effects of the drug's use (Gandhi, Globe and Mail, 6/27). Reid on Saturday while speaking on a panel at the SOGC meeting said a recent article in the journal Contraception showed that about 50% of women without severe menstrual cycle-related complications would prefer to suppress their periods (Lev, CP/Canada, 6/24).
"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.
Extra Support Helps Obese Women Cycle To And From Work
Increased daily exercise can prevent diabetes and cardiovascular disease in obese women, but getting started and maintaining new habits is a challenge. A new study by researchers at the Swedish medical university Karolinska Institutet shows that extra support and encouragement can help more women to exercise to and from work.
"Physically active transport is probably our best bet for helping populations at risk of heart disease and diabetes to increase physical activity levels, since we have to spend time getting to and from work anyway," says Dr Erik Hemmingsson, who led the study now published online in the International Journal of Obesity.
The study was carried out at the Obesity Unit at Karolinska University Hospital in Stockholm and lasted 18 months. It involved 120 obese and unfit women between the ages of 30 and 60 with a waist circumference of at least 88 centimetres (34.6 inches). The subjects were randomly assigned to two groups, a control group that focused on walking and an intervention group that focused on cycling.
The control group was given pedometers and attended two two-hour group meetings, at which they were encouraged to walk to and from work to attain a daily step count of 10,000. The cycling group received the same support plus three individual consultations with a physician, who provided each women with a Physical activity on Prescription (PaP) specifically encouraging them to cycle to and from work. They also attended two additional group meetings and were lent a new ladies' bicycle during the 18 months.
The results show that a larger proportion of the women in the intervention group (39%) cycled two kilometres or more per day than the women in the control group (9%).
"Bearing in mind that many of the women in the cycling group hadn't been on a bike since they were children, it was gratifying to see that so many of them actually managed to cycle regularly to work," says Dr Hemmingsson.
Roughly the same proportion of women in both groups achieved the goal of 10,000 steps a day which suggests that cycling does not have to detract from daily walks.
"The support programme given to the intervention group was deliberately not particularly expensive since we wanted the programme to be a feasible option for primary care," adds Dr Hemmingsson. "A positive side-effect was that car-driving dropped by 34 per cent."
Publication: "Increased physical activity in abdominally obese women through support for changed commuting habits: a randomised clinical trial", Hemmingsson E, Udd?©n J, Neovius M, Ekelund U, R?¶ssner S, International Journal of Obesity, online 5 May 2009, DOI: 10.1038/ijo.2009.77.
Source
Karolinska Institutet
"Physically active transport is probably our best bet for helping populations at risk of heart disease and diabetes to increase physical activity levels, since we have to spend time getting to and from work anyway," says Dr Erik Hemmingsson, who led the study now published online in the International Journal of Obesity.
The study was carried out at the Obesity Unit at Karolinska University Hospital in Stockholm and lasted 18 months. It involved 120 obese and unfit women between the ages of 30 and 60 with a waist circumference of at least 88 centimetres (34.6 inches). The subjects were randomly assigned to two groups, a control group that focused on walking and an intervention group that focused on cycling.
The control group was given pedometers and attended two two-hour group meetings, at which they were encouraged to walk to and from work to attain a daily step count of 10,000. The cycling group received the same support plus three individual consultations with a physician, who provided each women with a Physical activity on Prescription (PaP) specifically encouraging them to cycle to and from work. They also attended two additional group meetings and were lent a new ladies' bicycle during the 18 months.
The results show that a larger proportion of the women in the intervention group (39%) cycled two kilometres or more per day than the women in the control group (9%).
"Bearing in mind that many of the women in the cycling group hadn't been on a bike since they were children, it was gratifying to see that so many of them actually managed to cycle regularly to work," says Dr Hemmingsson.
Roughly the same proportion of women in both groups achieved the goal of 10,000 steps a day which suggests that cycling does not have to detract from daily walks.
"The support programme given to the intervention group was deliberately not particularly expensive since we wanted the programme to be a feasible option for primary care," adds Dr Hemmingsson. "A positive side-effect was that car-driving dropped by 34 per cent."
Publication: "Increased physical activity in abdominally obese women through support for changed commuting habits: a randomised clinical trial", Hemmingsson E, Udd?©n J, Neovius M, Ekelund U, R?¶ssner S, International Journal of Obesity, online 5 May 2009, DOI: 10.1038/ijo.2009.77.
Source
Karolinska Institutet
GlaxoSmithKline Announces Expanded Indication For Hycamtin(R) To Treat Cervical Cancer In Combination Chemotherapy
GlaxoSmithKline (NYSE:
GSK) announced today that the U.S. Food and Drug Administration (FDA)
approved Hycamtin (topotecan HCl) in combination with cisplatin, for the
treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix,
which is not amenable to curative treatment with surgery and/or radiation
therapy. Following a six-month priority review by the FDA, the expanded
indication is based on Phase III results that demonstrated a survival
advantage by using Hycamtin in combination with cisplatin compared to
cisplatin alone.
"Advanced cervical cancer can have a very poor prognosis, even with
current treatments, so physicians are always looking for new and effective
therapies," said Bradley Monk, M.D., Associate Professor, Division of
Oncologic Gynecology at University of California, Irvine. "These results
show that Hycamtin extended the survival of these women, which is the
ultimate goal."
The randomized, multicenter trial was designed and conducted by the
Gynecologic Oncology Group (GOG) and results were published last year in
the Journal of Clinical Oncology. The study found that Hycamtin, in
combination with cisplatin, was effective in treating cervical cancers
which were not amenable to curative treatment with surgery and/or radiation
therapy.
"The expanded use of Hycamtin in treating these patients with cervical
cancer demonstrates GSK's ongoing commitment to bringing therapies to
physicians for the treatment of women with cancer," said Kevin Lokay, Vice
President of Oncology and Acute Care at GSK. "In addition to developing
treatments, GSK is also developing therapies for the prevention of this
disease. We are currently developing a vaccine for Human Papilloma Virus
(HPV), the leading cause of cervical cancer."
About the trial
The trial enrolled women with measurable, histologically-proven stage
IVB, recurrent or persistent carcinoma of the cervix, who had recovered
from the effects of prior surgery, radiation or chemoradiation. Patients
were originally randomized into three arms: single-agent cisplatin (n=146,
50 mg/m2, every 21 days), Hycamtin plus cisplatin (n=147, Hycamtin 0.75
mg/m2, day 1-3 plus cisplatin 50 mg/m2 day 1 every 21 days), or MVAC
(methotrexate, vinblastine, doxorubicin, and cisplatin every 28 days).
However, the MVAC arm was closed after 64 patients were enrolled, due to
excessive toxicity.
(1)
The study showed a statistically significant improvement in overall
survival for Hycamtin plus cisplatin arm (log-rank P=0.033). Median
survival for Hycamtin plus cisplatin was 9.4 months when compared to 6.5
months for cisplatin alone.(1) This GOG study was led by Dr. Harry J. Long
III, Professor of Oncology at Mayo Clinic College of Medicine in Rochester,
Minn.
The Hycamtin plus cisplatin combination was generally well-tolerated.
The most common dose-limiting toxicity was myelosuppression. Major
hematologic adverse events (Grade 3 and 4) were more frequent in the
combination arm than in the single-agent arm and included neutropenia (74%
vs. 2%), thrombocytopenia (33% vs. 3%), Infection-febrile neutropenia (19%
vs. 8%), respectively. The most common non-hematologic adverse events
reported were constitutional*, Gastrointestinal, pain and metabolic
toxicities.
About Hycamtin
Hycamtin is currently marketed in the United States by GlaxoSmithKline.
It belongs to a class of drugs known as the topoisomerase I (topo-I)
inhibitors. Topo-I is a naturally produced protein essential for cell
division in both normal and cancer cells. Interaction between topo-I and
Hycamtin results in permanent damage to the cell's genetic material and the
death of dividing cancer cells. Hycamtin was originally approved for the
treatment of small cell lung cancer sensitive disease after failure of
first-line chemotherapy and for the treatment of metastatic carcinoma of
the ovary after failure of initial or subsequent chemotherapy. For more
information and full prescribing information, visit
hycamtin.
Important Safety Information
Hycamtin can suppress the body's ability to produce disease fighting
white blood cells, a condition known as neutropenia. In addition, the
amount of clotting cells can decrease (thrombocytopenia). Generally,
Hycamtin has a mild to moderate non-hematologic toxicity profile. Side
effects include nausea, vomiting, diarrhea and hair loss (alopecia).
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit gsk.
GlaxoSmithKline
gsk
View drug information on Hycamtin.
GSK) announced today that the U.S. Food and Drug Administration (FDA)
approved Hycamtin (topotecan HCl) in combination with cisplatin, for the
treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix,
which is not amenable to curative treatment with surgery and/or radiation
therapy. Following a six-month priority review by the FDA, the expanded
indication is based on Phase III results that demonstrated a survival
advantage by using Hycamtin in combination with cisplatin compared to
cisplatin alone.
"Advanced cervical cancer can have a very poor prognosis, even with
current treatments, so physicians are always looking for new and effective
therapies," said Bradley Monk, M.D., Associate Professor, Division of
Oncologic Gynecology at University of California, Irvine. "These results
show that Hycamtin extended the survival of these women, which is the
ultimate goal."
The randomized, multicenter trial was designed and conducted by the
Gynecologic Oncology Group (GOG) and results were published last year in
the Journal of Clinical Oncology. The study found that Hycamtin, in
combination with cisplatin, was effective in treating cervical cancers
which were not amenable to curative treatment with surgery and/or radiation
therapy.
"The expanded use of Hycamtin in treating these patients with cervical
cancer demonstrates GSK's ongoing commitment to bringing therapies to
physicians for the treatment of women with cancer," said Kevin Lokay, Vice
President of Oncology and Acute Care at GSK. "In addition to developing
treatments, GSK is also developing therapies for the prevention of this
disease. We are currently developing a vaccine for Human Papilloma Virus
(HPV), the leading cause of cervical cancer."
About the trial
The trial enrolled women with measurable, histologically-proven stage
IVB, recurrent or persistent carcinoma of the cervix, who had recovered
from the effects of prior surgery, radiation or chemoradiation. Patients
were originally randomized into three arms: single-agent cisplatin (n=146,
50 mg/m2, every 21 days), Hycamtin plus cisplatin (n=147, Hycamtin 0.75
mg/m2, day 1-3 plus cisplatin 50 mg/m2 day 1 every 21 days), or MVAC
(methotrexate, vinblastine, doxorubicin, and cisplatin every 28 days).
However, the MVAC arm was closed after 64 patients were enrolled, due to
excessive toxicity.
(1)
The study showed a statistically significant improvement in overall
survival for Hycamtin plus cisplatin arm (log-rank P=0.033). Median
survival for Hycamtin plus cisplatin was 9.4 months when compared to 6.5
months for cisplatin alone.(1) This GOG study was led by Dr. Harry J. Long
III, Professor of Oncology at Mayo Clinic College of Medicine in Rochester,
Minn.
The Hycamtin plus cisplatin combination was generally well-tolerated.
The most common dose-limiting toxicity was myelosuppression. Major
hematologic adverse events (Grade 3 and 4) were more frequent in the
combination arm than in the single-agent arm and included neutropenia (74%
vs. 2%), thrombocytopenia (33% vs. 3%), Infection-febrile neutropenia (19%
vs. 8%), respectively. The most common non-hematologic adverse events
reported were constitutional*, Gastrointestinal, pain and metabolic
toxicities.
About Hycamtin
Hycamtin is currently marketed in the United States by GlaxoSmithKline.
It belongs to a class of drugs known as the topoisomerase I (topo-I)
inhibitors. Topo-I is a naturally produced protein essential for cell
division in both normal and cancer cells. Interaction between topo-I and
Hycamtin results in permanent damage to the cell's genetic material and the
death of dividing cancer cells. Hycamtin was originally approved for the
treatment of small cell lung cancer sensitive disease after failure of
first-line chemotherapy and for the treatment of metastatic carcinoma of
the ovary after failure of initial or subsequent chemotherapy. For more
information and full prescribing information, visit
hycamtin.
Important Safety Information
Hycamtin can suppress the body's ability to produce disease fighting
white blood cells, a condition known as neutropenia. In addition, the
amount of clotting cells can decrease (thrombocytopenia). Generally,
Hycamtin has a mild to moderate non-hematologic toxicity profile. Side
effects include nausea, vomiting, diarrhea and hair loss (alopecia).
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit gsk.
GlaxoSmithKline
gsk
View drug information on Hycamtin.
Videos Discuss Midterm Elections, Guatemalan STI Experiment, Abortion Access In Peru
The following summarizes selected women's health related videos.
Abortion-Rights Issues Heat Up Midterms: Candidates from both parties are using the issue of abortion rights to rally voters ahead of next month's midterm elections. In discussing GOP candidates' positions, MSNBC's Rachel Maddow recently commented on Sarah Palin's claims that the health reform law (PL 111-148) represents "the biggest expansion of the abortion industry in America" (Maddow, "The Rachel Maddow Show," MSNBC, 10/6). Craig Varoga, president of the Patriot Majority PAC, joined Maddow to discuss an ad his group developed to draw attention to GOP Senate candidate Sharron Angle's position that abortion should not be available to rape victims (Maddow, "The Rachel Maddow Show," MSNBC 10/1). Meanwhile, NARAL Pro-Choice New York launched an ad highlighting New York gubernatorial candidate Carl Paladino's opposition to abortion rights in all cases (NARAL Pro-Choice New York, 9/28).
STI Experiment Prompts U.S. Apology: Chris Matthews of "Hardball" spoke with NBC News Chief Health Correspondent Robert Bazell about revelations that the U.S. conducted experiments in the 1940s that involved infecting hundreds of Guatemalans with gonorrhea and syphilis without their permission or knowledge. An unpublished study on the experiment was recently discovered by Wellesley College researcher Susan Reverby (Matthews, "Hardball," MSNBC, 10/1). "Countdown" host Keith Olbermann also discussed the experiment, which prompted apologies from U.S. officials this week (Olbermann, "Countdown," MSNBC, 10/1).
Peruvian Girl Denied Abortion Access: The video tells how doctors in Peru refused to perform surgery on a 13-year-old girl who became pregnant through rape because they feared it would end her pregnancy, even though therapeutic abortion is legal in the country. The Center for Reproductive Rights is pursuing a case with the Peruvian government to obtain reparations for the girl - who is now paralyzed in her legs -- and ensure that women's rights are protected in the future (Center for Reproductive Rights, 10/6).
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.
Childhood Environment Influences Reproductive Function
A study led by researchers at UCL (University College London) demonstrates that female reproductive function is influenced by childhood environment. This suggests there is a critical window of time from about 0-8 years of age that determines the rate at which girls physically mature and how high their reproductive hormone levels reach as adults.
Published today in PLoS Medicine, the study compares reproductive hormone levels of groups of Bangladeshi women who migrated at different periods of their life. It finds that women who migrated from Bangladesh to the UK during infancy and early childhood reach puberty earlier, are taller, and have up to 103 per cent higher levels of the hormone progesterone as adults in comparison to women who migrated at a later age, as well as those who had remained in Bangladesh. These higher hormone levels could potentially increase a woman's ability to conceive.
Lead author Dr Alejandra N???±ez de la Mora, UCL Department of Anthropology, said: "The findings point to the period before puberty as a sensitive phase when changes in environmental conditions positively impact on key developmental stages. Put very simply, the female body seems to monitor its environment throughout childhood and before puberty, to gauge when and at what rate it will be best to mature. It then sets development, including reproductive hormone levels, accordingly. This is an advantage in evolutionary terms, as it makes the best of the resources and energy available for reproduction in any given circumstance.
"Girls who migrate at a young age seem to mature more quickly when they find themselves in an environment where the body has more access to energy. In other words, when they're under less physical strain due to factors like a better diet and general health. When energy is a limited resource, it must be allocated between maintenance, growth, and reproductive functions - the body makes trade-offs within the constraints it experiences. When conditions are better, these constraints are relaxed and more energy is diverted towards reproduction."
The results of this study are relevant not only to Bangladeshi groups, but to other migrant groups and populations in transition worldwide. These findings add to accumulating evidence that humans have an evolved capacity to respond to chronic environmental conditions during growth and to make decisions about how to apportion energy between reproductive and other bodily functions.
Five groups of women were selected and compared for the study. These included women who had grown up in Bangladesh but moved to the UK as adults; those who had moved to the UK as children; second generation Bangladeshi women living in the UK; women who were born and raised in Bangladesh; and a comparison group of women of European descent who were born and raised in the UK. Bangladeshi migrants were chosen for this study because of the long and on-going history of migration to the UK and the general contrasts in conditions between the two countries.
The subjects in each group gave saliva samples over an extended period, to measure levels of the female hormones progesterone and oestradiol. These are key fertility hormones, influencing the female menstrual cycle, pregnancy and embryonic development. Health information and body measurements were also provided by the subjects.
Co-author Dr Gillian Bentley, UCL Department of Anthropology, who directed the project added: "The theory that early environmental factors may affect reproductive function has been suggested previously by anthropologists*, but this field study is the first to use measurements of hormone levels to demonstrate a link between childhood environment and reproductive maturation and function. However, hormone levels are not just relevant to reproduction. The significant increase in progesterone levels that we document in migrant women may result, for example, in higher breast cancer risks in subsequent generations of this community. The potential health implications are far-reaching."
Bangladesh, in South Asia, is one of the most densely populated countries in the world. The Bangladeshis who took part in the study were middle class women from the Sylhet District. Although a relatively affluent area of the country, inhabitants still suffer from higher immune challenges, primarily due to poor sanitation and limited access to healthcare. These aspects of the environment in Bangladesh are thought to be responsible for the slower development of the Bangladeshi women who grew up there.
The study was co-authored by Dr Robert Chatterton in Obstetrics and Gynaecology at Northwestern University, Chicago who supervised the laboratory work, and Dr Osul Choudhury of the Sylhet Osmani Medical College, Bangladesh who co-ordinated research with Dr N???±ez de la Mora in Bangladesh.
-- The paper 'Childhood Conditions Influence Adult Progesterone Levels' is in the latest edition of PLOS Medicine, doi:10.1371/journal.pmed.0040167
-- Dr Gillian Bentley and Dr Alejandra N???±ez de la Mora conducted this research while working for UCL's Department of Anthropology. They both now work at Durham University.
-- *This theory was developed by Professor Peter Ellison, founder and principal investigator of Harvard University's Reproductive Ecology Laboratory.
About UCL
Founded in 1826, UCL was the first English university established after Oxford and Cambridge, the first to admit students regardless of race, class, religion or gender, and the first to provide systematic teaching of law, architecture and medicine. In the government's most recent Research Assessment Exercise, 59 UCL departments achieved top ratings of 5* and 5, indicating research quality of international excellence.
UCL is the fourth-ranked UK University in the 2006 league table of the top 500 world Universities produced by the Shanghai Jiao Tong University. UCL alumni include Mahatma Gandhi (Laws 1889, Indian political and spiritual leader); Jonathan Dimbleby (Philosophy 1969, writer and television presenter); Alexander Graham Bell (Phonetics 1860s, inventor of the telephone), and members of the band Coldplay.
ucl.ac
Published today in PLoS Medicine, the study compares reproductive hormone levels of groups of Bangladeshi women who migrated at different periods of their life. It finds that women who migrated from Bangladesh to the UK during infancy and early childhood reach puberty earlier, are taller, and have up to 103 per cent higher levels of the hormone progesterone as adults in comparison to women who migrated at a later age, as well as those who had remained in Bangladesh. These higher hormone levels could potentially increase a woman's ability to conceive.
Lead author Dr Alejandra N???±ez de la Mora, UCL Department of Anthropology, said: "The findings point to the period before puberty as a sensitive phase when changes in environmental conditions positively impact on key developmental stages. Put very simply, the female body seems to monitor its environment throughout childhood and before puberty, to gauge when and at what rate it will be best to mature. It then sets development, including reproductive hormone levels, accordingly. This is an advantage in evolutionary terms, as it makes the best of the resources and energy available for reproduction in any given circumstance.
"Girls who migrate at a young age seem to mature more quickly when they find themselves in an environment where the body has more access to energy. In other words, when they're under less physical strain due to factors like a better diet and general health. When energy is a limited resource, it must be allocated between maintenance, growth, and reproductive functions - the body makes trade-offs within the constraints it experiences. When conditions are better, these constraints are relaxed and more energy is diverted towards reproduction."
The results of this study are relevant not only to Bangladeshi groups, but to other migrant groups and populations in transition worldwide. These findings add to accumulating evidence that humans have an evolved capacity to respond to chronic environmental conditions during growth and to make decisions about how to apportion energy between reproductive and other bodily functions.
Five groups of women were selected and compared for the study. These included women who had grown up in Bangladesh but moved to the UK as adults; those who had moved to the UK as children; second generation Bangladeshi women living in the UK; women who were born and raised in Bangladesh; and a comparison group of women of European descent who were born and raised in the UK. Bangladeshi migrants were chosen for this study because of the long and on-going history of migration to the UK and the general contrasts in conditions between the two countries.
The subjects in each group gave saliva samples over an extended period, to measure levels of the female hormones progesterone and oestradiol. These are key fertility hormones, influencing the female menstrual cycle, pregnancy and embryonic development. Health information and body measurements were also provided by the subjects.
Co-author Dr Gillian Bentley, UCL Department of Anthropology, who directed the project added: "The theory that early environmental factors may affect reproductive function has been suggested previously by anthropologists*, but this field study is the first to use measurements of hormone levels to demonstrate a link between childhood environment and reproductive maturation and function. However, hormone levels are not just relevant to reproduction. The significant increase in progesterone levels that we document in migrant women may result, for example, in higher breast cancer risks in subsequent generations of this community. The potential health implications are far-reaching."
Bangladesh, in South Asia, is one of the most densely populated countries in the world. The Bangladeshis who took part in the study were middle class women from the Sylhet District. Although a relatively affluent area of the country, inhabitants still suffer from higher immune challenges, primarily due to poor sanitation and limited access to healthcare. These aspects of the environment in Bangladesh are thought to be responsible for the slower development of the Bangladeshi women who grew up there.
The study was co-authored by Dr Robert Chatterton in Obstetrics and Gynaecology at Northwestern University, Chicago who supervised the laboratory work, and Dr Osul Choudhury of the Sylhet Osmani Medical College, Bangladesh who co-ordinated research with Dr N???±ez de la Mora in Bangladesh.
-- The paper 'Childhood Conditions Influence Adult Progesterone Levels' is in the latest edition of PLOS Medicine, doi:10.1371/journal.pmed.0040167
-- Dr Gillian Bentley and Dr Alejandra N???±ez de la Mora conducted this research while working for UCL's Department of Anthropology. They both now work at Durham University.
-- *This theory was developed by Professor Peter Ellison, founder and principal investigator of Harvard University's Reproductive Ecology Laboratory.
About UCL
Founded in 1826, UCL was the first English university established after Oxford and Cambridge, the first to admit students regardless of race, class, religion or gender, and the first to provide systematic teaching of law, architecture and medicine. In the government's most recent Research Assessment Exercise, 59 UCL departments achieved top ratings of 5* and 5, indicating research quality of international excellence.
UCL is the fourth-ranked UK University in the 2006 league table of the top 500 world Universities produced by the Shanghai Jiao Tong University. UCL alumni include Mahatma Gandhi (Laws 1889, Indian political and spiritual leader); Jonathan Dimbleby (Philosophy 1969, writer and television presenter); Alexander Graham Bell (Phonetics 1860s, inventor of the telephone), and members of the band Coldplay.
ucl.ac
First Solid Evidence That Viral Transmission Through Breast Milk Can Be Prevented
An antiretroviral drug already in widespread use in the developing world to prevent the transmission of HIV from infected mothers to their newborns during childbirth has also been found to substantially cut the risk of subsequent HIV transmission during breast-feeding.
In a study presented Feb. 4 at the 2008 Conference on Retroviruses and Opportunistic Infections in Boston, an international team of AIDS experts reports that nevirapine given once daily to breast-feeding infants from 8 to 42 days old decreased by almost half the rate of HIV transmission via breast-feeding at 6 weeks of age. The decrease occurred in comparison to a single dose of nevirapine given to infants at birth, the current standard of care. At 6 months of age, the risk of postnatal HIV infection or death in infants who received the six-week regimen was almost one-third less than the risk for infants given only a single dose. The study was led by three teams of investigators at The Johns Hopkins University in collaboration with investigators in Ethiopia, India and Uganda.
Breast-feeding remains a leading route of HIV transmission in the developing world. The United Nations World Health Organization estimates that approximately 150,000 infants are infected through breast-feeding each year. In the United States each year, fewer than 150 newborns are infected with HIV at birth, mostly to mothers who did not know they were HIV positive.
The study, conducted from 2001 to 2007 and involving approximately 2,000 infants, is one of the first randomized controlled trials to show that a drug can prevent HIV transmission to uninfected babies exposed to their infected mothers' breast milk.
According to Johns Hopkins scientists, the results are highly significant because the low-dose regimen of nevirapine was able to reduce transmission or death in breast-feeding infants. They note that the extended-nevirapine regimen appears to be as safe as the single-dose regimen.
The study is also significant, the scientists say, because it is the first to show that an antiretroviral drug can prevent HIV transmission through mucosal tissue.
This finding has implications for the potential value of antiretroviral drugs for preventing sexual transmission of HIV.
The six-week extended nevirapine trial, or SWEN study, included more than 200 scientists and staff collaborating in many countries. The project was directed by Johns Hopkins investigators J. Brooks Jackson, M.D., M.B.A., and Laura Guay, M.D., with colleagues at the Makerere University/Johns Hopkins University Research Collaboration in Kampala, Uganda; by Andrea Ruff, M.D., with colleagues at Addis Ababa University in Addis Ababa, Ethiopia; by Robert Bollinger, M.D., M.P.H., with colleagues at BJ Medical College in Pune, India.; and Lawrence Moulton, Ph.D., of Johns Hopkins, principal statistician for the study.
The SWEN study was funded by the Division of AIDS at the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health. Nevirapine is manufactured by the German pharmaceutical company Boehringer Ingelheim and sold under the brand name Viramune.
For additional information, go to:
ccghe.jhmi.edu/
clinicaltrials/
(NCT00074399 and NCT00061321)
Source: David March
Johns Hopkins Medical Institutions
View drug information on Viramune.
In a study presented Feb. 4 at the 2008 Conference on Retroviruses and Opportunistic Infections in Boston, an international team of AIDS experts reports that nevirapine given once daily to breast-feeding infants from 8 to 42 days old decreased by almost half the rate of HIV transmission via breast-feeding at 6 weeks of age. The decrease occurred in comparison to a single dose of nevirapine given to infants at birth, the current standard of care. At 6 months of age, the risk of postnatal HIV infection or death in infants who received the six-week regimen was almost one-third less than the risk for infants given only a single dose. The study was led by three teams of investigators at The Johns Hopkins University in collaboration with investigators in Ethiopia, India and Uganda.
Breast-feeding remains a leading route of HIV transmission in the developing world. The United Nations World Health Organization estimates that approximately 150,000 infants are infected through breast-feeding each year. In the United States each year, fewer than 150 newborns are infected with HIV at birth, mostly to mothers who did not know they were HIV positive.
The study, conducted from 2001 to 2007 and involving approximately 2,000 infants, is one of the first randomized controlled trials to show that a drug can prevent HIV transmission to uninfected babies exposed to their infected mothers' breast milk.
According to Johns Hopkins scientists, the results are highly significant because the low-dose regimen of nevirapine was able to reduce transmission or death in breast-feeding infants. They note that the extended-nevirapine regimen appears to be as safe as the single-dose regimen.
The study is also significant, the scientists say, because it is the first to show that an antiretroviral drug can prevent HIV transmission through mucosal tissue.
This finding has implications for the potential value of antiretroviral drugs for preventing sexual transmission of HIV.
The six-week extended nevirapine trial, or SWEN study, included more than 200 scientists and staff collaborating in many countries. The project was directed by Johns Hopkins investigators J. Brooks Jackson, M.D., M.B.A., and Laura Guay, M.D., with colleagues at the Makerere University/Johns Hopkins University Research Collaboration in Kampala, Uganda; by Andrea Ruff, M.D., with colleagues at Addis Ababa University in Addis Ababa, Ethiopia; by Robert Bollinger, M.D., M.P.H., with colleagues at BJ Medical College in Pune, India.; and Lawrence Moulton, Ph.D., of Johns Hopkins, principal statistician for the study.
The SWEN study was funded by the Division of AIDS at the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health. Nevirapine is manufactured by the German pharmaceutical company Boehringer Ingelheim and sold under the brand name Viramune.
For additional information, go to:
ccghe.jhmi.edu/
clinicaltrials/
(NCT00074399 and NCT00061321)
Source: David March
Johns Hopkins Medical Institutions
View drug information on Viramune.
Merck's Gardasil Effective At Preventing HPV, Cervical Disease In Older Women, Study Finds
Merck's human papillomavirus vaccine, Gardasil, was 90% effective in preventing infection with the virus and cervical disease in women ages 24 to 45, according to a study published Monday in the medical journal Lancet, Reuters reports (Fox, Reuters, 6/1). In the U.S., the vaccine currently is FDA-approved for girls and women ages nine to 26. Centers for Disease Control and Prevention guidelines recommend routine three-dose vaccination of girls ages 11 and 12 and for girls and women ages 13 to 26 who have not yet been vaccinated (CDC fact sheet, June 2008). It is designed to protect against HPV types 16 and 18, which cause about 70% of all cervical cancer cases, and HPV types 6 and 11, which cause genital warts.
The new study, led by Nubia Munoz of the National Institute of Cancer in Bogota, Colombia, and funded by Merck, involved women ages 24 to 45 with no history of cervical disease or genital warts who either received the vaccine or a placebo injection. The study found that women who received the vaccine were significantly less likely to be infected with certain strains of HPV than those who received placebo shots. According to the researchers, four women out of 1,900 who received the vaccine developed HPV or cervical disease after two years, compared with 41 women out of 1,900 in the placebo group.
Reuters reports that the results of the study could help Merck as it seeks approval for marketing Gardasil for use in older women. The researchers said in the study that older women might be at risk for HPV infection as "[c]hanges in sexual behavior during the past 30 years ... have led to more widespread premarital sexual intercourse and acquisition of new sexual partners around middle age." They added, "As the potential for HPV infection and disease exists in women in their third, fourth and fifth decades of life, these women could benefit from prophylactic HPV vaccination." According to Reuters, a mathematical model published in October 2005 showed that vaccinating older women could cut rates of cervical cancer in women through age 45 by half. Merck also has released data showing the effectiveness of the vaccine in preventing genital lesions in men.
According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection worldwide, and about 20 million U.S. residents are infected with it. The virus is the leading cause of cervical cancer, which causes about 3,870 deaths in the U.S. and 300,000 deaths globally every year, and it also can cause anal, penile, mouth and neck cancer (Reuters, 6/1).
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.
View drug information on Gardasil.
The new study, led by Nubia Munoz of the National Institute of Cancer in Bogota, Colombia, and funded by Merck, involved women ages 24 to 45 with no history of cervical disease or genital warts who either received the vaccine or a placebo injection. The study found that women who received the vaccine were significantly less likely to be infected with certain strains of HPV than those who received placebo shots. According to the researchers, four women out of 1,900 who received the vaccine developed HPV or cervical disease after two years, compared with 41 women out of 1,900 in the placebo group.
Reuters reports that the results of the study could help Merck as it seeks approval for marketing Gardasil for use in older women. The researchers said in the study that older women might be at risk for HPV infection as "[c]hanges in sexual behavior during the past 30 years ... have led to more widespread premarital sexual intercourse and acquisition of new sexual partners around middle age." They added, "As the potential for HPV infection and disease exists in women in their third, fourth and fifth decades of life, these women could benefit from prophylactic HPV vaccination." According to Reuters, a mathematical model published in October 2005 showed that vaccinating older women could cut rates of cervical cancer in women through age 45 by half. Merck also has released data showing the effectiveness of the vaccine in preventing genital lesions in men.
According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection worldwide, and about 20 million U.S. residents are infected with it. The virus is the leading cause of cervical cancer, which causes about 3,870 deaths in the U.S. and 300,000 deaths globally every year, and it also can cause anal, penile, mouth and neck cancer (Reuters, 6/1).
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.
View drug information on Gardasil.
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