суббота, 31 декабря 2011 г.

UCSF Research Shows Private Umbilical Cord Banking Is Not Cost-Effective

Private cord blood banking is not cost-effective because it costs an additional $1,374,246 per life-year gained, according to a new analysis by UCSF researchers. The research team also concluded that private cord blood banking is cost-effective only for families with a child with a very high likelihood of needing a stem cell transplant.



The researchers used a technique called decision analysis that tracks hypothetical groups of people and allows comparison of expected costs and health benefits of two alternative strategies (in this case, private cord blood banking versus no cord blood banking). Results of the study appear in the October 2009 issue of the journal Obstetrics & Gynecology.



Cord blood is collected from the umbilical cord shortly after a baby's birth and has the potential to treat a variety of medical conditions ranging from leukemia to metabolic disorders to cerebral palsy. Public cord blood banks store cord blood at no cost and make the blood available to anyone needing treatment, or for research purposes.



Private cord banks charge a fee to store a baby's cord blood for his/her own possible future use or for a family member's possible future use.



"While there are plausible medical advantages of umbilical cord blood stem cells, many of these benefits are primarily theoretical at this point," said Aaron Caughey, MD, PhD, co-author of the paper, a UCSF associate professor of obstetrics, gynecology and reproductive sciences, and director of the UCSF Center for Clinical and Policy Perinatal Research. "Expectant parents need to understand the true likelihood of their family benefitting from private cord blood banking in order to make an informed decision about this expensive process."



Private umbilical cord blood banking companies in the United States market directly to consumers, at times describing cord blood as a "biologic insurance" for their unborn child, the researchers note. However, a survey of private cord blood banks by the American Society for Blood and Marrow Transplantation found that of the approximately 460,000 cord blood units banked, only 99 were confirmed as being shipped for use in treatment.



The decision-analytic model used by the research team included four baseline assumptions: a cost of $3,620, the lowest price quoted from major blood banking company web sites, for umbilical cord blood banking and storage for 20 years; a .04 percent chance of requiring an autologous (self) or stem cell transplant; a .07 percent chance of a sibling requiring an allogenic (from another person) stem cell transplant; and a 50 percent reduction in risk of graft-versus-host disease if a sibling receives a transplant of banked umbilical cord blood cells.



The UCSF team concluded that if the cost of umbilical cord blood banking is less than $262 or the likelihood of a child needing a stem cell transplant is greater than one out of 110, then private umbilical cord blood banking becomes cost-effective.



The American Academy of Pediatrics (AAP) encourages cord blood donation when the cord blood is stored in a bank for public use and discourages storing cord blood as "biological insurance" because there currently are no scientific data to support autologous transplantation. The AAP does encourage private cord blood banking when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) who potentially could benefit from cord blood transplantation.



"The discrepancy between the benefits of private cord blood banking perceived by families and the lack of benefit seen in this analysis, and in the opinions of professional societies, has important implications for how doctors counsel patients," said Anjali Kaimal, MD, MAS, lead author of the study and a recent graduate of the UCSF Maternal-Fetal Medicine fellowship which is directed by Caughey. Kaimal's work on the study was done while at UCSF; she currently is a physician at Massachusetts General Hospital.



Co-authors of the study are Catherine Smith, MD; Russell K. Laros, Jr, MD; and Yvonne W. Cheng, MD, MPH, all from UCSF.



Caughey's work is supported in part by a grant from the Robert Wood Johnson Foundation Physician Faculty Scholars Program.



Source:
Karin Rush-Monroe


University of California - San Francisco

суббота, 24 декабря 2011 г.

HIV Transmission May Be Slowed Following Study Of 'Good Bacteria' In Women

Beneficial bacteria found in healthy women help to reduce the amount of vaginal HIV among HIV-infected women and might make it more difficult for the virus to spread, boosting the possibility that "good bacteria" might someday be tapped in the fight against HIV.



The findings come from physicians and scientists at the University of Washington and the University of Rochester Medical Center, who worked together in an effort to learn more about how HIV survives and spreads from person to person. The study involving 57 women was done in Seattle and Rochester through the Women's HIV Interdisciplinary Network (WHIN), which is based at the University of Washington.



The team studied the vaginal environment, examining the mix of bacteria that reside there and taking into account several other factors. Physicians tracked the level of HIV virus in the vagina as well as infection by common sexually transmitted diseases like trichomoniasis, gonorrhea and chlamydia, and other more common types of vaginal infections.



Physicians also monitored the levels of beneficial bacteria known as Lactobacillus in the vagina, as well as hydrogen peroxide, which is produced by the bacteria and hinders the virus. They also measured the level of HIV in the women's blood and the rate of progression of the disease overall.



The team found that women with hydrogen-peroxide-producing Lactobacillus in the vagina had lower levels of HIV virus in genital secretions - what physicians call the genital viral load. Physicians know that the lower the level of HIV in the sexual tract, the less likely that the virus will be spread from person to person through sexual contact.



Scientists have previously recognized from laboratory studies that Lactobacillus might give women some natural protection against HIV. The bacteria, commonly found in most women, bind to the virus and secrete hydrogen peroxide. The bacteria are a close cousin of the Lactobacillus bacteria found in the small intestine, a type of "good" bacteria widely found in yogurt.



While previous work in the laboratory has indicated that Lactobacillus might help prevent HIV infection in women, the current study actually links, in women, decreased levels of the virus in the vagina with the presence of Lactobacillus that produce hydrogen peroxide there.



The team also found that the amount of the virus in the vagina varied in step with the presence of Lactobacillus: Women who did not have the bacteria at first but who had acquired it by a subsequent visit had their vaginal HIV levels drop, while vaginal HIV levels increased in women in whom the good bacteria had disappeared between visits.



The research was presented this week at the Conference on Retroviruses and Opportunistic Infections in Boston by Jane Hitti, M.D., associate professor in the Department of Obstetrics & Gynecology at the University of Washington School of Medicine. Hitti has been working closely with Robert Coombs, M.D., Ph.D., the principal investigator for the WHIN study and professor of Laboratory Medicine and of Medicine at the University of Washington. Amneris Luque, M.D., associate professor of Medicine and medical director of the AIDS Center at Strong Memorial Hospital, and Susan Cohn, M.D., associate professor of Medicine at the University of Rochester School of Medicine and Dentistry, also took part in the study.
















"These findings underscore the importance of maintaining a healthy, Lactobacillus-dominant vaginal flora for HIV-positive women," said Hitti. "I hope that we can explore Lactobacillus replacement in the future for women who do not have this bacteria, as a strategy to decrease the amount of HIV in the vagina."



"The research opens up some doors," said Luque. "Sexual activity is the most common mode of transmission of HIV. Perhaps we can make it less likely to spread by somehow taking advantage of good bacteria as a natural way to stop HIV and prevent transmission. These findings are striking, though preliminary, and should be looked at further."



Luque and Cohn both care for patients at Strong's AIDS clinic, which provides ongoing care for approximately 900 patients with HIV. The center is part of a broader AIDS treatment and research effort at the University of Rochester Medical Center. The University is the only institution in the nation to be part, since inception, of two major national AIDS research efforts - the search for a vaccine, and the testing of new treatments. More than 3,000 Rochester-area residents have taken part in treatment and vaccine studies at the University's HIV/AIDS Clinical Trials Unit, funded by the National Institute of Allergy and Infectious Diseases.



Cohn stresses the importance of HIV-positive women participating in clinical research. "These women made a large contribution to knowledge about HIV and reproductive health by participating in this study. Advances in the care of HIV-positive women really depend on the dedication of study subjects."







Source: Tom Rickey


University of Rochester Medical Center

суббота, 17 декабря 2011 г.

63% Of Women Report Sexual Problems With Orgasm Proving Biggest Issue In Teens And 20s

Almost two-thirds of females attending a general urology practice reported that they suffered from sexual dysfunction, according to a paper in the August issue of BJUI.


Dysfunction rose with age in all categories except orgasm, with more than half of women aged from 18 to 30 reporting orgasm problems, significantly higher than women aged 31 to 54.


Researchers asked 587 women aged from 18 to 95, who attended a urology clinic in New Jersey, about six key areas of female sexual dysfunction (FSD): lack of desire, arousal issues, lack of lubrication, problems achieving orgasm, lack of satisfaction and pain during intercourse.


"We found that 63% of the women suffered from FSD and that there were significant links between FSD and age, menopausal status and use of selective antidepressants" says co-author Dr Debra Fromer, head of the Center for Bladder, Prostate and Pelvic Floor Health at Hackensack University Medical Center, New Jersey.


Twelve per cent of the women who took part in the study were aged 18-30, 27% were 31-45, 25% were 46-54, 24% were 55-70 and 12% were 70 plus.


They attended a typical American metropolitan urology practice caring for conditions such as urinary incontinence, urinary tract infections, pelvic floor problems and kidney stones.


Key findings of the survey included:


-- The most sexually active age groups were 31-45 year-olds (87%), 18-30 year-olds (85%) and 46-54 year-olds (74%). It then fell sharply in 55-70 year-olds (45%) and in women who were over 70 (15%).


-- The top overall problem was lack of desire (47%), followed by orgasm problems (45%), arousal issues (40%), lack of satisfaction (39%), lack of lubrication (37%) and pain (36%).


-- Five of the six categories increased as the women got older: desire from 36 to 96%, arousal from 27 to 54%, lubrication from 26 to 45%, satisfaction from 28 to 88% and pain from 10 to 56%.


-- The only category that bucked the trend was orgasm, with problems higher in the 18-30 age group (54%) than in the 31-45 (43%) and 46-54 (48%) age groups. It then rose to 66% at 55-70 and 87% when women were over 70.


The top three problems by age group were:


-- 18-30: orgasm (54%), desire (36%) and satisfaction (28%)


-- 31-45: desire (48%), orgasm (43%) and satisfaction (40%)


-- 46-54: desire (65%), satisfaction (53%) and orgasm (48%)


-- 55-70: desire (77%), orgasm (66%), satisfaction (65%)


-- Over 70: desire (96%), satisfaction (88%) and orgasm (87%).


"FSD can have a major effect on women's quality of life" says Dr Fromer. "Self-esteem, sense of wholeness and relationships can be seriously and adversely affected, exacting a heavy emotional toll.


"Researchers have found significant associations between major categories of sexual dysfunction, reduced physical and emotional satisfaction and general well-being.


"That is why it is so important to ensure that problems are identified and tackled wherever possible. For example a number of hormone and other drug treatments have been shown to benefit women with FSD."


Known risk factors for FSD include age, a history of sexual abuse or sexually transmitted infections, depression, lower socioeconomic status, lifestyle, overall physical health and sexual experience.


"Interestingly, our study found very similar levels of dysfunction to an age-matched Turkish study" adds Dr Fromer. "This suggests a biological cause for FSD rather than societal or cultural factors, although they make some contribution to certain psychological aspects of the disorder."


Source: Wiley - Blackwell

суббота, 10 декабря 2011 г.

New York Health Commission Recommends Closure Of Hospital That Specializes In Childbirth

The New York state Commission on Health Care Facilities in the 21st Century last week released a report that recommended the closure of Victory Memorial Hospital and Skilled Nursing Center in New York City -- which specializes in childbirth and serves many Chinese and Russian immigrants, the New York Times reports (Mindlin, New York Times, 12/3). New York Gov. George Pataki (R) and the state Legislature formed the commission last year to recommend changes to the state's health care system, which is the most expensive in the country. The commission's report recommends nine hospital closures and the reconfiguration of 48 additional hospitals in the state. Pataki and Gov.-elect Eliot Spitzer (D) on Wednesday endorsed the report (Kaiser Daily Health Policy Report, 11/30). Victory Memorial has a program for pregnant Muslim women to receive care by only female physicians and nurses. In addition, the hospital contains phones with two handsets so physicians and patients can speak with outside interpreters. "The ethnic minorities we serve don't have automobiles," Donald Zarou, chief of obstetrics and Victory Memorial, said, adding, "What are they going to do, wait for a bus while they have three-minute contractions?" According to the Times, the hospital might close next year unless it is spared by the bankruptcy protection it filed last month (Mindlin, New York Times, 12/3).

"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.

суббота, 3 декабря 2011 г.

Vaginal Ring Could Protect Against HIV, Researcher Says

A researcher with Weill Cornell Medical College has developed a vaginal ring that releases microbicides and could prevent HIV and unplanned pregnancies, ANI/Times of India reports. Brij Saxena -- a professor of reproductive biology and endocrinology and lead author of a recent study on the ring in the journal AIDS -- said that laboratory testing showed the device would be effective at preventing HIV infection and pregnancy by releasing several types of nonhormonal agents and microbicides. He added that if proven successful in clinical trials, the device would allow women to effectively protect themselves from HIV and avoid pregnancy.

According to Saxena, the ring releases antiretroviral drugs over a period of 28 days. He noted that the device potentially could serve as an alternative method to prevent other sexually transmitted infections. Jeffrey Laurence, co-author of the study and a physician at New York Presbyterian Hospital-Weill Cornell Medical Center, said, "No one has ever conquered a viral epidemic with treatment, so prevention is the most effective option." He added, "Ideally, an HIV vaccine is the most desirable method, but that is not foreseeable in the near future. The next best thing would be something that would prevent infection and put the power in the susceptible female partner's control. That's the potential a device such as this can offer" (ANI/Times of India, 5/20).


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.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

суббота, 26 ноября 2011 г.

Exercise Helps With Body Image, Depression In Pregnancy

Exercise can help expectant moms in mind as well as body. A new study suggests that women who stay active and are more positive about their changing shapes might protect themselves from depression both during and after pregnancy.


"Our study supports the psychological benefits of exercise to improve body image and lessen depressive symptoms," said lead study author Danielle Symons Downs, Ph.D., associate professor of kinesiology and obstetrics and gynecology at Penn State University.


Downs and colleagues surveyed 230 Pennsylvania women throughout pregnancy and the postpartum period about their symptoms of depression, exercise habits and feelings about weight, appearance and other aspects of body image. Their findings appear in the August issue of the journal Annals of Behavioral Medicine.


As expected and consistent with previous research, women who experienced depressive symptoms early in pregnancy tended to report later pregnancy and postpartum depression, the authors found.


What is new, though, are the findings about the role of body image and exercise behavior in relation to pregnancy and postpartum depressive symptoms. Women who experienced higher levels of depression symptoms also reported less satisfaction with their appearance throughout the trimesters of pregnancy.


"If someone is depressed and not very happy with how their body looks, especially with regard to the physical changes that occur during pregnancy, it can influence depression later on," Downs said.


Women who reported more depressive symptoms during the first trimester tended to engage in less exercise behavior in early pregnancy. In addition, women who exercised more prior to their pregnancy had greater body satisfaction during the second and third trimesters and less depressive symptoms in the second trimester, which suggests that avid pre-pregnancy exercise might protect women from negative depressive symptoms and body dissatisfaction during mid-to-late pregnancy, Downs said.


"There is no question that pregnant women, in consultation with their health care providers, should try to maintain a regular and moderate exercise regimen," said Michael O'Hara, Ph.D., professor of psychology at the University of Iowa.


However, O'Hara said that the study design especially the classification of exercise frequency and intensity and the arbitrary cut-offs used to classify women "did not give a strong endorsement for the protective effects of exercise during pregnancy, at least with regard to depression."


Beginners should take it easy when exercising, he advises: Women could keep up with what they were doing beforehand physically, but they should not go all-out during pregnancy if they were sedentary before.


"There is increasing evidence that anxiety and stress during pregnancy are bad for the mother and for the fetus. The take-home message is that pregnancy is a time when women need to be given permission to slow down their pace and focus on taking care of themselves with good nutrition, moderate exercise and plenty of rest and relaxation when possible," O'Hara said.


The American College of Sports Medicine recommends that healthy pregnant women without obstetric complications engage in 30 minutes of moderate exercise most, if not all, days of the week.


.
Annals of Behavioral Medicine is the official peer-reviewed publication of The Society of Behavioral Medicine. For information about the journal, contact Alan J. Christensen, Ph.D., at (319) 335-3396. Visit the Society of Behavioral Medicine at springer/public+health/journal/12160.


Downs DS, DiNallo JM, Kirner TL. Determinants of pregnancy and postpartum depression: Prospective influences of depressive symptoms, body image satisfaction, and exercise behavior. Annals of Behavioral Medicine 36(1), 2008


Health Behavior News Service

Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210

Washington

DC 20009

hbns

суббота, 19 ноября 2011 г.

Senate Confirms Hamilton To Federal Appeals Court

The Senate on Thursday voted 59-39 to confirm U.S. District Court Judge David Hamilton to the Chicago-based U.S. Court of Appeals for the 7th Circuit, the New York Times reports. Hamilton's home-state senator, Richard Lugar (R-Ind.), was the only Republican to vote for his confirmation.

Hamilton was President Obama's first judicial nominee, announced March 19, but Republicans have opposed the nomination (Phillips, New York Times, 11/20). On Tuesday, the Senate voted 70-29 to invoke cloture and end debate on Hamilton's nomination, setting up a confirmation vote.

CQ Today reports that Hamilton's confirmation is significant because it shows that the Senate will be able to confirm Obama's judicial nominees if Senate Majority Leader Harry Reid (D-Nev.) elects to invoke cloture -- as long as the Democratic caucus remains united. The Republican caucus's inability to block Hamilton -- "the most controversial of the pending judicial nominees" -- shows that "it is unlikely that the GOP can hold up any others that Reid might bring to the floor," according to CQ Today (Vadala, CQ Today, 11/19).

Hamilton received strong support from Lugar as well as the backing of the conservative Federalist Society (Women's Health Policy Report, 11/17). However, Senate Republicans, led by Senate Judiciary Committee ranking member Sen. Jeff Sessions (R-Ala.), labeled Hamilton an activist, citing his rulings on abortion and Christian prayer, the AP/Houston Chronicle reports.

With the addition of Hamilton, the 7th Circuit will have seven Republican-nominated judges and four chosen by Democrats (Margasak, AP/Houston Chronicle, 11/19).


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.

суббота, 12 ноября 2011 г.

An Assessment Of The Value Of Treatments To Increase Height

Dr. Leona Cuttler, a pediatric endocrinologist and growth hormone expert from University Hospitals Rainbow Babies and Children's Hospital, is the co-author of an editorial in the New England Journal of Medicine commenting on a new study that found giving girls with Turner syndrome low doses of estrogen, as well as growth hormone, years before the onset of puberty, increases their height and offers other benefits.



With her co-author Dr. Robert L. Rosenfield, a pediatric endocrinologist with the University of Chicago Medical Center, Dr. Cuttler writes, "The use of growth hormone and estrogen has a long and often controversial history in the manipulation of growth."



About the new study, they write that the results confirm those of previous, less rigorous studies showing that treatment with growth hormone significantly increased adult height in patients with Turner's syndrome.



Drs. Cuttler and Rosenfield say the results suggest a modest but intriguing synergism between growth hormone and low-dose estrogen in promoting growth.



"The impact of these findings on practice and policy will depend not only on their statistical significance but also on whether the observed changes in height translate into clinically meaningful benefit. The ability to increase height should not be the sole yardstick for assessing benefit," the editorial states.



"Since growth hormone is well entrenched in the management of Turner's syndrome, the current findings support this aspect of practice but are not likely to change it. Yet the results underscore the need for a measured approach, which includes avoiding unrealistic expectations, when families embark on growth hormone therapy. The early use of low-dose estrogen in conjunction with growth hormone is an interesting possibility. An optimal estrogen-replacement regimen could potentially shorten the period of growth hormone treatment, reduce costs, and improve patient satisfaction. However, implementation would be hampered by the lack of a convenient means to deliver the very small estrogen doses that seem to be optimal for height augmentation."



The authors advise caution when considering supplementing growth hormone treatment with early, low-dose estrogen in Turner's syndrome. "The current results show trends that do not consistently reach significance and show only modest synergy between growth hormone and estrogen in achieving height augmentation, as compared with growth hormone alone. The suggested potential benefits of estrogen on cognition are based on earlier short-term data, and long-term data are needed. We must be concerned about unexpected risks posed by estrogen, being mindful of surprising adverse outcomes of estrogen use in other settings," they write.



According to the National Institutes of Health, Turner syndrome occurs in 1 out of 2,500 female births worldwide and develops when a female (X) sex chromosome is missing in cells or is abnormal. These girls are typically of short stature and have a loss of ovarian function.



Source:

George Stamatis

University Hospitals Case Medical Center

суббота, 5 ноября 2011 г.

Fetal Cell "Transplant" Could Be A Hidden Link Between Childbirth And Reduced Risk Of Breast Cancer

Some benefits of motherhood are intangible, but one has been validated through biostatistical research: women who bear children have a reduced risk of developing breast cancer. In Seattle, Washington, researchers at the University of Washington and Fred Hutchinson Cancer Research Center believe they have identified a source of this protective effect: fetal cells "transplanted" to the mother before birth.


Their findings are presented in the October 1 issue of Cancer Research, a journal of the American Association for Cancer Research.


The ability of cells from a growing fetus to take up long-term residence within its mother is a phenomenon called fetal microchimerism. According to the researchers, while fetal microchimerism has been implicated as a mechanism of autoimmune disease, it may also benefit mothers by putting the immune system on alert for malignant cells to destroy.


To test the idea, the researchers recruited 82 women, 35 of whom had been diagnosed with breast cancer. Approximately two-thirds of the women studied have had children, and more than half of the participants had given birth to at least one son. The researchers took blood samples from each participant and searched them for male DNA, as they reasoned it is a relatively definitive matter to detect the male Y chromosome amid the mother's native and obviously female cells within a blood sample.


Among the women with breast cancer, only five had male DNA in their bloodstream. Three of the five previously gave birth to sons, one had had an abortion and the other had never been knowingly pregnant. In total, about 14 percent of all women in the breast cancer group had male DNA in their bloodstream compared to 43 percent of women in the non-breast cancer group.


"Our research found that these persisting fetal cells may be giving a woman an edge against developing breast cancer," said lead author Vijayakrishna K. Gadi, M.D., Ph.D., assistant professor at the University of Washington and research associate at the Fred Hutchinson Cancer Research Center. "This experiment of nature is all the more fascinating because for years doctors treated a number of different cancers by transplanting cells from one person to another."


According to Dr. Gadi, these findings could provide a starting point for future research on the role of fetal microchimerism in the prevention of cancer. In addition, there are other reasons for male DNA to be in a woman's peripheral blood, such as miscarriage and abortion or possibly even blood transfusion or a male twin that was reabsorbed into the womb at an early stage of the pregnancy.


Funding for this study was provided by the National Institutes of Health and Amgen, Inc. Breast cancer patients were recruited through a breast cancer specialty clinic at the Seattle Cancer Care Alliance, which is affiliated with both the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine.


The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes nearly 26,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.


American Association for Cancer Research (AACR)

615 Chestnut Street, 17th Floor

Philadelphia, PA 19106

United States

aacr

суббота, 29 октября 2011 г.

Online Map Of Maternal Health To Inform And Influence World Leaders

Researchers from the University of Southampton have helped construct an online interactive world map which gives stark facts and figures about the health of women during pregnancy, childbirth and following the birth of their child.



Social scientists Professor Zo?« Matthews and Dr Sarah Neal are working in collaboration with the White Ribbon Alliance for Safe Motherhood and the University of Aberdeen on a joint project worth in excess of ??160,000 called 'The Atlas of Birth', which also includes a book, short film and flyers.


"We are using data from the United Nations and the World Health Organization to give a comprehensive picture of maternal health from around the world. Part of the project involves presenting the information in an easy-to-use online map, to help get key facts direct to policymakers," comments Professor Matthews of the University's Centre for Global Health, Population, Poverty and Policy.


Funded by the Partnership for Maternal, Newborn and Child Health and the Norwegian government, the project includes statistics on a wide range of issues including maternal deaths, pregnancies to very young girls and midwife contact.


Latest figures from the WHO show more than 99 percent of maternal deaths occur in developing countries and most of these in a handful of nations. Most of the very high rates of death are seen in sub-Saharan Africa, but India has the highest number of deaths, with 63,000 women dying every year.


Women in developing countries often become a mother very young, experience many closely spaced births, and run a risk as high as one in 11 of dying in childbirth across their lifetimes. In particular, girls under the age of 15 are five times more likely to die giving birth than women in their 20s.


Care from a midwife or professional with midwifery skills during birth is key to saving lives of both mothers and newborns. Despite this, the figures show two thirds of women in the poorest countries deliver without a midwife or other health worker.


"This interactive map will enable advocates across the world to quickly and effectively lobby governments, influence policymakers and inform the media, as public pressure grows to end the tragic and almost always preventable deaths of girls and women in childbirth," comments Brigid McConville, Director of the WRA in the UK.


The new online world map was unveiled at the PMNCH Partner's Forum in Delhi, India (Nov 2010).


Source: Southampton University

суббота, 22 октября 2011 г.

Are There Any Factors That Can Influence The Probability Of Giving Birth To A Baby Boy Or Girl?

A slightly greater number of males than females are born worldwide every year. In recent decades, although there are still more baby boys born than girls, there has been an apparent decline in the ratio of male to female newborns in several industrialized countries, including Canada, Denmark, England, Germany, Japan and the United States. That has led researchers to ask: Are there any factors that can influence the probability of giving birth to a baby boy or girl? A new study from the Harvard School of Public Health (HSPH) and Karolinska Institutet in Stockholm, Sweden, found that mothers who experienced an increase in weight from the beginning of the first pregnancy to the beginning of the second pregnancy may be slightly more likely to give birth to a baby boy during their second pregnancy. The study appears online September 24, 2007 in the journal Fertility & Sterility.



"The results are provocative because few biological factors are known in humans to influence the chances of either conceiving or carrying to term a baby boy or girl. Our study suggests that maternal nutritional factors might play a role," said Eduardo Villamor, assistant professor of international nutrition at HSPH and lead author of the study.



Some prior studies had looked at what factors might influence the sex ratio, but evidence of causality has been weak. Parental smoking, for example, has been associated with both lower and higher sex ratios. Maternal nutritional status had been studied, but there was little evidence to support a causal relationship with the sex ratio. One of the hypotheses that the authors of this study wanted to test was whether the increase in maternal obesity in several industrialized countries could play a role in the declining sex ratio. Their study found the opposite--maternal weight gain seemed to favor the birth of boys.



The study population, drawn from the Swedish Birth Registry, included 220,889 women who had successive pregnancies between 1992 and 2004 (live births and stillbirths were included). The researchers analyzed the change in women's body mass index (BMI) between the first and second pregnancies. (BMI is weight in kilograms divided by the square of height in meters.) The male to female sex ratio of the second pregnancy increased linearly with the amount of weight change from the first to second pregnancy, from 1.024 in women who lost more than 1 unit BMI to 1.080 in women who gained 3 or more units (a male to female sex ratio of 1.000 would indicate an equal number of boys and girls being born). The trend was independent of obstetric complications, maternal smoking, parental age, length of the interpregnancy interval and the sex or survival status of the first-born child.



The data suggest that interpregnancy weight gain appears related to a slight increase in the probability of giving birth to a baby boy during a second pregnancy. The obesity epidemic does not appear to explain the observed decline in the sex ratio in some industrialized countries, which indicates that there are factors still unknown influencing the probability of giving birth to boys or girls.



The authors are careful to note that women should not gain weight to try to influence the sex of their baby. "Weight gain before pregnancy carries significant risks to the mother and the baby, and should not be practiced to influence the odds of having a boy," said Villamor. "Other factors of which weight gain is only an indicator could be at play here."







Sven Cnattingius, professor of reproductive epidemiology at the Karolinska Institutet in Stockholm, Sweden, was senior author of the study.



The study was supported by grants from the Karolinska Institutet. Villamor is supported in part by the National Institutes of Health and the Department of Nutrition at HSPH.



Click here for link to abstract.



"Interpregnancy Weight Gain and the Male-to-Female Sex Ratio of the Second Pregnancy: A Population-Based Cohort Study," Eduardo Villamor, P?¤r Spar?©n, Sven Cnattingius, Fertility & Sterility, online September 24, 2007.



Source: Todd Datz


hsph.harvard.edu/

суббота, 15 октября 2011 г.

Positive Phase II Results With Orally Active GnRH Receptor Antagonist In Endometriosis - Neurocrine Biosciences Inc

Neurocrine Biosciences,
Inc. (Nasdaq: NBIX) today announced positive results of its 'proof of
concept', safety, efficacy and dose-finding Phase II clinical trial using
its proprietary, orally-active small molecule Gonadotropin-Releasing
Hormone (GnRH) receptor antagonist (NBI-56418).


The 3-month data comes from a multi-center, randomized, double-blind,
placebo-controlled trial involving patients with a confirmed diagnosis of
endometriosis. The study followed a parallel-group design in which 76
subjects were randomized to one of three treatment groups: placebo, 75 mg
of NBI-56418, or 150 mg of NBI-56418 each administered once daily. Dosing
started on Day 2 to Day 7 of the menstrual cycle and continued over 12
weeks with assessments of symptoms and signs of disease conducted at 4-week
intervals using the Composite Pelvic Sign and Symptoms Score (CPSSS).
Assessment of pain intensity was measured daily by a Visual Analog Scale
(VAS) and collected by electronic diary. Full data regarding treatment
impact on menses, hormones and a variety of metabolic biomarkers will be
available at the completion of the ongoing 3-month safety follow-up period.


The primary endpoint of the study was reduction in the CPSSS, a
validated clinical endpoint assessing subjective and objective elements of
endometriosis. For the CPSSS, which has a maximum possible value of 15,
mean values at baseline were 9.1, 8.5 and 8.0 for the placebo, 75 mg and
150 mg groups respectively. After treatment, there were reductions of 3.7
(placebo), 3.9 (75 mg) and 5.0 (150 mg) points in the score at week 12.


A patient-completed VAS was used to record pain intensity on a daily
basis. Mean values for each 4-week interval were analyzed. This reveals
dose-related improvements of 5 (placebo), 14 (75 mg) and 21 (150 mg) from
baseline means of 31.2, 34.9 and 33.5 respectively. From a safety
perspective, preliminary information on the adverse event rates show that
there is little difference in the percentage of patients with an adverse
event across treatment groups. Treatment-related adverse events occurred in
39%; 36%; and 26% of the patients in the placebo, 75 mg and 150 mg groups
respectively. There was no increase in hot flashes in the NBI-56418 treated
groups compared with placebo.


"We are pleased with the results demonstrating a robust treatment
effect with NBI-56418 as shown by two clinical outcome measures. The
reductions in scores at the highest dose were at the levels expected for
peptide agonists such as Lupron Depot(R), which while efficacious, can lead
to numerous undesirable side effects and limit utility. While not fully
analyzed, preliminary results show that our GnRH antagonist demonstrated
reductions in pain scores at the earlier time points in the study," said
Chris O'Brien, M.D., Senior Vice President of Clinical Development for
Neurocrine Biosciences.















"We have met our 'proof of concept' criteria in the clinical setting
with our GnRH antagonist. Since the effects of estradiol reduction have
been previously well correlated with a reduction of pain and other symptoms
of endometriosis, we believe our oral GnRH antagonist will have significant
therapeutic application in endometriosis. These new data are encouraging
and suggest that sufficient estradiol suppression has been achieved for
pain reduction while potentially avoiding reduction in bone mineral density
and the other undesirable metabolic consequences of GnRH agonist
therapies," said Wendell Wierenga, Ph.D. Executive Vice President of
Research and Development for Neurocrine Biosciences.


"Based on these data, we are moving ahead to select the dosing regimen
for an expanded six-month study in patients with endometriosis. This Phase
IIb study will include several hundred patients and is expected to be
initiated in the 3rd Quarter of 2006," added Wierenga.


Additional Phase II Clinical Studies Underway with GnRH for
Endometriosis


Neurocrine is continuing to enroll patients in a second Phase II study
in patients with endometriosis that was initiated in December 2005 to
explore once vs. twice daily dosing. This study, a multi-dose,
double-blind, placebo-controlled trial, is enrolling 72 patients and is
designed to assess safety and efficacy over a three-month period. The
primary endpoint of reduction in endometriotic pain will be measured by the
CPSSS. Preliminary results are expected to be announced in the 4th Quarter
of 2006.


Neurocrine will be initiating a Phase IIb study in the 3rd quarter of
2006 in which patients with endometriosis will receive NBI-56418 for six
months. In addition to confirming the effect of NBI-56418 on endometriotic
pain, this study is designed to assess the impact of treatment on bone
mineral density. The six-month results, together with data from ongoing
Phase II studies will be the basis for securing agreement to a registration
plan acceptable to the FDA, estimated to occur next year. Finally, the
company recently started a Phase I study in male volunteers as part of the
Benign Prostate Hyperplasia development program. The Company expects to
provide more details on the six month trial together with ongoing results
from the Phase I trial in the 3rd Quarter of 2006.


Background


Nearly 7 million women in the US have endometriosis, many with severe
or moderate symptoms. Many patients are believed to be misdiagnosed or
undiagnosed. The impact of endometriosis on the lives of sufferers can be
significant -- adversely affecting the ability of patients to maintain
relationships and employment.


Surgery and medical treatments are currently available for women with
endometriosis. Surgery is not acceptable to many patients. Although
indicated for endometriosis, medical therapies such as the injectable GnRH
agonists leuprolide or injectable progesterone are associated with a range
of potentially unacceptable side effects including bone loss. Consequently,
prescribing physicians often reserve these medical interventions for
patients with severe endometriosis. For the majority of endometriosis
patients suffering from moderate or mild symptoms, the remaining treatment
options, oral contraceptives and analgesics, are only partially effective.


Based on the large number of endometriosis sufferers and the
significant level of unmet need, we believe a highly attractive commercial
opportunity exists for a new product that is able to offer patients and
prescribers effective control of endometriosis symptoms with limited side
effects.


Neurocrine Biosciences, Inc. is a product-based biopharmaceutical
Company focused on neurological and endocrine diseases and disorders. Our
product candidates address some of the largest pharmaceutical markets in
the world including insomnia, anxiety, depression, diabetes, irritable
bowel syndrome, and autoimmunity. Neurocrine Biosciences, Inc. news
releases are available through the Company's website via the Internet at
neurocrine


In addition to historical facts, this press release may contain
forward-looking statements that involve a number of risks and
uncertainties. Among the factors that could cause actual results to differ
materially from those indicated in the forward looking statements are risks
and uncertainties associated with Neurocrine's business and finances in
general including the risks and uncertainties associated with, or arising
out of, drug discovery, pre-clinical and clinical development of
pharmaceutical products. Specifically, the Company faces risks and
uncertainties arising out of it GnRH clinical development program including
risk that its lead candidate, NBI-56418, will not proceed to later stage
clinical trials; risk that should NBI-56418 may prove unsuitable for
continued development, the Company will not be successful in identifying
alternative GnRH antagonist products that are safe and effective; risk
relating to the Company's dependence on contract manufacturers for GnRH
antagonist product clinical drug supply and compliance with regulatory
requirements for marketing approval; risks that the Company may be
dependent on corporate collaborators for commercial manufacturing and
marketing and sales activities for its GnRH antagonist products;
uncertainties relating to patent protection for the Company's GnRH
antagonist products and intellectual property rights of third parties;
risks and uncertainties relating to competitive products and technological
changes that may limit demand for the Company's GnRH antagonist products;
risk that the Company will be unable to raise additional funding required
to complete development of its GnRH antagonist product candidates; and the
other risks described in the Company's report on Form 10-K for the year
ended December 31, 2005. Neurocrine undertakes no obligation to update the
statements contained in this press release after the date hereof.


Neurocrine Biosciences, Inc.

neurocrine


View drug information on Estradiol Transdermal System; Lupron Depot.

суббота, 8 октября 2011 г.

Latest WHO Handbook Presents Family Planning Options For Women Around The World

The recently released Family Planning: A Global Handbook for Providers includes a chapter on fertility-awareness based methods of family planning highlighting the Standard Days Method and the TwoDay Method, two family-planning methods developed by Georgetown University Medical Center's Institute for Reproductive Health, as effective, easy-to-use and without the health risks of chemically based family planning methods such as birth control pills.


The publication, developed by the World Health Organization, Johns Hopkins University, and the United States Agency for International Development, is used by family planning providers worldwide, especially in developing countries.


"With the inclusion of the Standard Days and TwoDay Methods in the WHO family planning handbook for providers, we anticipate that many more providers around the world will offer fertility awareness methods, thereby increasing women's access to these effective, easy-to-use, low-cost options," said Victoria Jennings, Ph.D., co-developer of the methods and director of the Institute for Reproductive Health. She is also professor of obstetrics and gynecology at Georgetown University Medical Center.


Utilizing data from sophisticated computer modeling of reproductive physiology and field studies, the Georgetown researchers developed the Standard Days Method and CycleBeads™, the simple visual aid used by women who follow the Standard Days Method. They enable a woman to identify the 12-day "fertile window" of her menstrual cycle. These 12 days take into account the life span of the woman's egg (about 24 hours) and the viable life of sperm (about 5 days) as well as the variation in the actual timing of ovulation. In a clinical trial, the Standard Days Method proved to be more than 95 percent effective with correct use, similar to other user-directed methods such as the pill. Because this natural method identifies all of the fertile days, it also helps couples who want a pregnancy to achieve their goal.


To use CycleBeads to follow the Standard Days Method, a woman moves a black rubber ring over a series of color-coded beads that represent her fertile and low fertility days. The day a woman starts her period she puts the rubber ring on CycleBeads' red bead. Each day she moves the ring one bead, always in the direction of the arrow. When the ring is on the red bead or a dark bead, there is very low likelihood of pregnancy. When the ring is on a glow-in-the-dark white bead - Days 8 through 19 - there is a high likelihood of getting pregnant. CycleBeads also helps a woman know if her cycle length is in the range (26-32 days long) for using this method effectively.


The TwoDay Method employs a very different approach to identifying the fertile days of a woman's menstrual cycle. TwoDay Method users monitor the presence or absence of cervical secretions. Women then use a simple formula to determine whether they should consider themselves fertile on a specific day. Georgetown studies have found this method to be 96 percent effective.















Additional information on the Standard Days Method and the TwoDay Method, including details for on-line training for healthcare providers, is available from the Institute for Reproductive Health at irh. In addition to being available from a growing number of reproductive health providers worldwide, CycleBeads can be purchased at retail outlets or over the internet at cyclebeads.


The WHO Global Family Planning Handbook can be found online at fphandbook. The Fertility Awareness Chapter (17) is located on pages 239-254.


About The Institute for Reproductive Health


The Institute for Reproductive Health is dedicated to helping women and men make informed choices about family planning and providing them with simple and effective natural options. As part of Georgetown University's School of Medicine, the Institute conducts research to develop natural methods of family planning and test them in service delivery settings. irh


About Georgetown University Medical Center


Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO).

gumc.georgetown.edu

суббота, 1 октября 2011 г.

2.5 Million Child Lives A Year Could Be Saved By Prioritizing Low-Cost, Simple Health Measures

Almost a third of the children under age five who die each year could be saved if governments rebalance health spending to ensure low-cost, simple interventions such as safe water and hygiene, bed nets and basic maternal and newborn care, leading aid agency World Vision said today. Currently, 8.8 million children a year die before age five, most of preventable causes.



A new report by the Christian humanitarian agency calls for scaling up simple preventive health measures for mothers and children, particularly at the community level. This must be a priority to make rapid progress against the top child killers of pneumonia, diarrhea and malaria, the international analysis shows. Citing interventions that can cost pennies, the study concludes that more strategic use of funding and resources would keep millions of children from dying before they reach their fifth birthdays.



"Our world is in the grip of a chronic humanitarian crisis with more than 24,000 children dying each day," said World Vision International's President Kevin Jenkins. "Yet we know that even in the poorest countries, most child deaths are not inevitable."



"The truth is politics, not poverty, is what is killing these children. For many politicians, saving infants and children from illness and death is simply not a priority. Our campaign will mobilize and equip people worldwide to hold their leaders to account for ensuring child health now," said Jenkins.



The report comes as World Vision launches Child Health Now, its first global advocacy campaign, for the 100 countries in which it works. The five-year initiative aims to help reduce child mortality by two-thirds by 2015 through ensuring government leaders deliver on their commitments to help meet this goal.*



"At least 2.5 million children's lives could be saved each year by implementing low-cost, simple interventions such as water and hygiene, bed nets, and basic maternal and newborn care," said World Vision's Jenkins. "As many as six million children could be saved yearly by combining these approaches with more strategic allocation of resources to meet needs at the community level, and by fulfilled global donor commitments."



In the U.S., government leaders have the opportunity to build on the country's global health funding leadership by appropriating the resources promised in last year's Global AIDS, TB and Malaria bill, and moving on to pass the newly introduced Global Child Survival Act of 2009, which calls for a clear, coordinated strategy to save the lives of newborns, infants and children in developing countries.



Recent history shows substantial progress is achievable: child deaths have been cut by more than half since 1960, when 20 million children died from preventable causes. Child mortality has decreased in all regions of the world because of increased access to interventions such as oral rehydration therapy and immunizations - and further progress can be made by expanding those approaches, emphasizing hand washing with soap and providing needed vitamins, among other basic steps



Report author Regina Keith, World Vision's senior health campaign adviser, said much health funding - both from donor nations and developing countries' budgets - is spent in ways that fail to have the greatest impact.



"Prevention is better, and cheaper, than treating children once they get ill," said Keith. "Yet an estimated 270 million children live in what amounts to a health care desert, lacking access to even the most basic provision, while millions more face patchy, low-quality systems they can't afford. If countries want to ensure the survival of their next generation, they must focus on providing low-cost, simple interventions to keep these young children healthy."



Source: Geraldine Ryerson-Cruz


World Vision

суббота, 24 сентября 2011 г.

Obama To Re-Nominate Johnsen To Head DOJ Office Of Legal Counsel

President Obama plans to re-nominate Dawn Johnsen as his choice for the head of the Department of Justice's Office of Legal Counsel after the Senate failed to take action on her nomination last year, according to a White House official, CQ Today reports (Perine, CQ Today, 1/7). Some Senate Republicans have argued that Johnsen is too controversial for the post given her criticism of legal memorandums OLC issued during the Bush administration. She also has drawn fire for her earlier work in support of abortion rights (CQ Today, 1/7).

Johnsen, an Indiana University law professor who served as acting head of OLC during the Clinton administration, was approved by the Senate Judiciary Committee in March 2009. However, the full Senate never voted on her nomination, in part because of criticism from the GOP (Savage, New York Times, 1/8).

In the past, Democratic Sen. Ben Nelson (Neb.) and then-Republican Arlen Specter (Pa.) had expressed reservations, although they have not declared how they would vote (CQ Today). Republican Sen. Richard Lugar (Ind.) has said he will support Johnsen (New York Times, 1/8).

Democratic advocates praised the resubmission. Marge Baker, executive vice president of People for the American Way, said, "President Obama made an excellent choice in Professor Johnsen to lead OLC, and today he's shown his willingness to stand on principle and call the Republicans on their attack and delay tactics."

Obama also re-nominated Louis Butler and Edward Chen, two choices for U.S. district court judgeships (CQ Today, 1/7).


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.

суббота, 17 сентября 2011 г.

Philadelphia Inquirer Examines Developments, Ethics In Microbicide Research

The Philadelphia Inquirer on Monday examined issues surrounding microbicide research, including recent developments and ethical issues. The Inquirer reports that the use of microbicides to prevent the spread of HIV "seemed so simple" 15 years ago, when researchers thought they could provide a vaginal gel that would be applied prior to sex. The gel would be "cheap and nonprescription, provide contraception and prevent many sexually transmitted infections, not just HIV," the Inquirer reports, adding that women also would be able to control its use, making microbicides "popular in places where men did not like wearing condoms -- that is, everywhere."

However, "the field's record is so disappointing that anything short of failure is cause for cheers," the Inquirer reports. More than $1 billion has been spent on research and development goals worldwide, with tens of thousands of women participating in clinical trials for potential microbicides that include things like lime juice, a seaweed extract and grain alcohol. The most recent development occurred in February when the International Partnership for Microbicides announced that an experimental gel -- PRO 2000 -- for the first time "had shown a hint more protection" against the virus than a placebo, according to the Inquirer. The trial -- which was conducted by researchers in Africa and Philadelphia -- was called "an important milestone," and Lisa Maslankowski, a researcher at the University of Pittsburgh who participated in the study, said that the PRO 2000 study was "the first time we've seen any signal of effectiveness, so this is very exciting for the field."

However, the results were statistically insignificant and indicated the gel's success "could have been a fluke," according to the Inquirer. The results from an ongoing trial of low-dose PRO 2000 are expected in late 2009. It would be considered statistically significant if the results showed a 33% decrease in HIV incidence, "a smidgen more than in the Philadelphia-Africa study," which could "pose another quandary," the Inquirer reports. Rowena Johnston, vice president of research at amFAR, said, "If we put out a marginally effective product, we know people would reduce their condom use. Then HIV infection would increase instead of decrease."

Advocates for microbicides are "undaunted," and there is a "new hope" that antiretroviral drugs could be used to prevent transmission of the virus. Still, "no one believes it will be simple," and many experts say the "science behind many studies was weak, the ethical quandaries were underestimated, and the basic rule of product development -- find out what the consumer wants -- was ignored," the Inquirer reports. In addition, microbicide research is "full of ethical and real-world dilemmas," including the fact that "developers cannot knowingly increase HIV risk while seeking a way to reduce it," the Inquirer reports. Women therefore are provided with condoms and "strenuously counseled to persuade their partners to wear them," but for some women in low-income countries their "only leverage may be the nominal payment" they are given for participating in the study. Anna Forbes, deputy director of the Global Campaign for Microbicides, said that women "can sometimes get their partners to use condoms during the trial because they are making money" but that condom use ends after the trial is over. Forbes said it is a "gray area ethically."














The failures of previous studies have led researchers to "now realize they need to come up with products that are not just good for women, but that women feel good using," the Inquirer reports, adding that once-daily formulations and slow-release vaginal rings are "in the works." Sharon Hillier, head of the federal Microbicide Trials Network and a researcher at the University of Pittsburgh, said the past decade "showed us there's no magic bullet." She also said that successes in preventing mother-to-child transmission through antiretrovirals have led researchers to explore pre-exposure prophylaxis. The Inquirer reports that this is a "radical shift," as the drugs are "neither cheap nor nonprescription" and come with "the danger of unintended consequences." Forbes said, "In poor countries, what are the odds that prevention pills would be taken from a woman and given to a family member with HIV?" In addition, there is a concern that expanded use of antiretrovirals could lead to drug resistance, "undermining treatment as well as prevention," the Inquirer reports (McCullough, Philadelphia Inquirer, 3/23).


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.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

суббота, 10 сентября 2011 г.

Brownback Reiterates Pledge That He Will Try To Overturn Roe If Elected President

Sen. Sam Brownback (Kan.), who is running for the Republican presidential nomination, on Saturday at a campaign event in West Des Moines, Iowa, reiterated his pledge that, if elected, he will try to overturn Roe v. Wade, the 1973 Supreme Court ruling that effectively barred state abortion bans, through appointing a Supreme Court justice, the Des Moines Register reports. Speaking at the Crossroads Fellowship, Brownback said the court is just one justice away from enough votes to overturn Roe, adding, "I want to be the president that appoints that justice" (Kauffman, Des Moines Register, 7/15).

Brownback attended seven campaign events throughout Iowa from July 13 to July 15 as part of his "Pro-Life, Whole-Life Tour," according to the Daily Iowan (Patton, Daily Iowan, 7/16). At another campaign event Saturday in Odebolt, Iowa, Brownback called on Rep. Tom Tancredo (Colo.), who also is running for the Republican nomination, to return campaign contributions from a longtime supporter who gave donations to a Planned Parenthood affiliate in Michigan, the Denver Rocky Mountain News reports (Sprengelmeyer, Denver Rocky Mountain News, 7/16).

Brownback on Saturday in an interview following the event said, "I've had people who've given funds to my campaign (but) when I saw where they were on the issues, I said, 'I don't want to associate with those individuals.'" Tancredo, who also attended the event, in an interview said, "Sen. Brownback knows better," adding, "He knows how I feel on the position of life (opposing abortion). It's disappointing. It's not a mark of a campaign with great integrity" (Rocky Mountain News, 7/16).

"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.

суббота, 3 сентября 2011 г.

Mother's Day And National Women's Health Week To Raise Awareness Of Gestational Diabetes

Most women with gestational diabetes know that taking steps to manage the disease during pregnancy is critical for the health of both mother and child. What many women don't realize is that those steps need to continue even after the baby is born.


Women who have had gestational diabetes are at increased risk for developing diabetes in the future, and their child is also at increased risk for obesity and type 2 diabetes. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Women's Health (ORWH) at the National Institutes of Health are teaming up this May to raise awareness of these risks as part of the National Diabetes Education Program's (NDEP's) "It's Never Too Early...to Prevent Diabetes" campaign.


"As we celebrate Mother's Day and National Women's Health Week May 9 through 15, we want all mothers with a history of gestational diabetes to be aware of their long-term health risks, the health risks faced by their children, and steps they can take to keep themselves and their families healthy," said Griffin P. Rodgers, M.D., director of the NIDDK.


Gestational diabetes occurs during pregnancy and affects about 7 percent of all U.S. pregnancies, or about 200,000 pregnancies each year. Women who have had gestational diabetes should be re-tested for diabetes six to 12 weeks after the baby is born, and at least every three years after that.


"Many women think that if the follow-up test after the baby is born shows no signs of diabetes, they are in the clear, but that's not the case," said Vivian Pinn, M.D., director of the ORWH. "What many of these moms don't know is that they have a 40 percent to 60 percent chance of developing diabetes as early as five to 10 years after their baby is born. These women need to know this information and they need to take steps to lower their risk for developing diabetes."


Women with a history of gestational diabetes can do a lot to prevent or delay the risk of developing diabetes. In addition to screening for diabetes, it is important for women to reach and maintain a healthy weight by making healthy food choices and being active for at least 30 minutes, 5 days a week. These action steps are good for the entire family and help mom and baby manage their risks for developing diabetes. Breastfeeding also helps protect against childhood obesity, which is a risk factor for type 2 diabetes. For mom, breastfeeding can also promote an earlier return to pre-pregnancy weight.


Gestational diabetes occurs more frequently among women with a family history of diabetes; overweight and obese women; and Hispanic/Latina, African-American, American Indian, Asian, Pacific Islander and Alaska Native women. Women who have had gestational diabetes should be screened regularly for diabetes and pre-diabetes, a condition where blood glucose levels are higher than normal, but not high enough to be diagnosed as diabetes. Follow-up screening usually consists of a simple blood test.















It is important that women talk to their doctors about their history of gestational diabetes. Women with a history of gestational diabetes should also talk to their obstetricians about earlier screening for gestational diabetes in future pregnancies. Because the children of women who had gestational diabetes are also at increased risk for obesity and type 2 diabetes, it's a good idea for mothers who had gestational diabetes to tell their child's pediatrician.


For a free tip sheet on gestational diabetes, including steps to reduce the risk of developing diabetes, call the National Diabetes Education Program at 1-888-693-NDEP (6337) or visit here. In addition, Women's Health Resources, a Web Portal developed by the National Library of Medicine and ORWH, will highlight NDEP materials and NIH research on gestational diabetes during National Women's Health Week, May 9 through 15.


The NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit here.


The NIH's Office of Research on Women's Health serves as the focal point for women's health research at the NIH. For more information about NIH's Office of Research on Women's Health, visit orwh.od.nih.


The National Diabetes Education Program, jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations, provides diabetes education to improve the treatment and outcomes for people with diabetes, promote early diagnosis, and prevent or delay the onset of diabetes. For more information, visit here.


Source

National Institutes of Health (NIH)

суббота, 27 августа 2011 г.

Report Alleges Inadequate Medical Treatment Of Female Immigrant Detainees In Arizona

Women held in three of Arizona's five immigrant detention facilities receive inadequate medical care, according to a report released on Tuesday by University of Arizona's Southwest Institute for Research on Women, the AP/Tucson Citizen reports. Arizona is the nation's biggest crossing point for undocumented immigrants, according to the AP/Citizen. Immigration and Customs Enforcement officials use five detention centers in the state to house 3,000 of 28,750 immigration detainees held daily nationwide.

For the report, third-year law students interviewed 42 people, including 21 women who were or had once been a detainee in the state. Two of the detainees were family members of the researchers and 19 were lawyers or social workers. The report focused on issues such as failing to recognize the mental health needs of the detainee, family separation, inadequate access to telephones and legal materials, and the penal conditions, such as shackling of women who are not being held for criminal offenses, according to the AP/Citizen.

The researchers cited specific cases, including a woman who was six-months pregnant and went without prenatal care for more than one month and another woman with cervical cancer who waited several months to see a nurse and was seen by an oncologist only after an emergency. Alessandra Soler Meetze, executive director of the Arizona Civil Liberties Union, said, "The sad thing is that these horror stories continue."

Katrina Kane, Arizona ICE detention and removal field director, said that those interviewed represent less than 0.0003% of the more than 72,000 immigrant detainee population in Arizona before being deported in fiscal year 2008. She added that all the medical facilities ICE uses are required to comply with the agency's national detention medical standards, and detainees are allowed to make no-cost phone calls to designated officials and legal organizations and counsel (Rotstein, AP/Tucson Citizen, 1/14).


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.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

суббота, 20 августа 2011 г.

Incoming Congress Should Enact Legislation To Reduce Abortion Rate, Opinion Piece Says

Although "[t]aking substantial steps to reduce the abortion rate will not settle the larger ethical argument over the practice," the "election of a new congressional majority" for the 110th Congress should "open the way for a better approach to the abortion question," Washington Post columnist E.J. Dionne writes in a Post opinion piece. The "bitter political brawling" over abortion during the past 30 years has caused an "unproductive stalemate" that has left antiabortion groups "frustrated," abortion-rights supporters "in a constant state of worry" and U.S. residents "who hold middle-ground positions feeling that there is no one who speaks for them," Dionne writes. However, "the politics of abortion began to change" in September with the introduction of a bill (HR 6067) sponsored by Rep. Tim Ryan (D-Ohio), who opposes abortion rights, and abortion-rights supporter Rep. Rosa DeLauro (D-Conn.) (Dionne, Washington Post, 11/21). The measure would require states to cover contraceptives for women with annual incomes of up to 200% of the federal poverty level, establish grants for sex education programs and require programs with a focus on abstinence to include thorough instruction on contraceptives. The legislation also would increase funding for health care for low-income women with children, provide no-cost visits from nurses to teens and women who have given birth for the first time, expand a tax credit for adoption and fund child care services for parents in college (Kaiser Daily Women's Health Policy Report, 9/20). There are "moral and practical reasons" for Democrats, Republicans, abortion-rights supporters and abortion-rights opponents to support the bill, Dionne writes. "Why shouldn't both sides embrace broader steps that, without coercion, could cut the abortion rate by much larger numbers?" Dionne asks, concluding that if Congress acts to curb the abortion rate, "it could show that politicians are capable of living up to their highest calling, which is to seek practical forms of moral seriousness" (Washington Post, 11/21).

"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.

суббота, 13 августа 2011 г.

San Francisco City Attorney Files Suit Alleging Gender Bias In California Health Insurance Laws

San Francisco City Attorney Dennis Herrera on Tuesday filed a lawsuit against the state of California alleging that state regulations that permit health insurers to charge women higher premiums than men are discriminatory and violate the state constitution, the Los Angeles Times reports. The suit alleges that California Insurance Commissioner Steve Poizner (R) and Cindy Ehnes, director of the Department of Managed Health Care, approved rules that permit so-called "gender rating," in which insurers can take into account a person's sex when determining premiums for individual policies. Women are being charged as much as 39% more than men for health insurance coverage, the suit contends.

Darrel Ng, a spokesperson for the insurance department, said, "The Legislature explicitly lists gender as one of the factors to be considered. Until the Legislature changes the laws or the courts decide differently, we will uphold the law" (Olivarez-Giles, Los Angeles Times, 1/28). Two California laws -- one passed in 1991 and the other in 2005 -- permit health insurers to take into account an individual's gender when determining premiums for individual health insurance policies (Daily Women's Health Policy Report, 1/5). Since December 2008, two bills to ban gender rating have been introduced in the Legislature. They are AB 119 by state Assembly Member Dave Jones (D) and SB 54 by state Sen. Mark Leno (D). Herrera said if the bills are signed into law, the suit could be dropped (Los Angeles Times, 1/28).


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.

суббота, 6 августа 2011 г.

BioMerieux Licenses Technology From Norchip To Launch A HPV Test For Cervical Cancer Risk Detection

BioMerieux and NorChip announced today that bioMerieux has entered into
a worldwide exclusive license agreement for rights developed by NorChip to
an innovative, m-RNA based Human Papillomavirus (HPV) diagnostic, for early
detection of cervical carcinogenesis. The test will use the NucliSENS
EasyQ(R) platform and be available during the second quarter of 2007.


"We are very pleased to enter this agreement as it increases the
opportunity to prevent cervical cancer, and provide all women,
irrespectively of age, with a better life through improved health," said
Dr. Geir Morland, CEO of NorChip. "An agreement with one of the world
leaders in the field of in vitro diagnostics enables accurate and
cost-effective prevention of cervical cancer worldwide," he added.



"The m-RNA based HPV assay developed by NorChip is an important
addition to our diagnostic portfolio, as it increases significantly our
commercial molecular diagnostic offering," stated Stephane Bancel, Chief
Executive Officer of bioMerieux. "This agreement fits exactly with our
strategy to focus on bringing clinicians diagnostic tests with high-medical
value."



The test will use the m-RNA based HPV detection technology developed
and patented by NorChip and the NASBA(R) Real-Time technology from
bioMerieux. Under the agreement, NorChip will license the patents and
related technology to bioMerieux, who will manufacture and distribute kits
for use with its proprietary NucliSENS EasyQ(R) system. The licensed
technology utilizes the fact that cells integrated with DNA from oncogenic
HPV virus strains express oncogenic proteins based on continuous expression
of abnormal m-RNA. These findings have been published in nine international
peer-reviewed publications, and clinical utility of this approach has been
documented in more than 20 studies covering over 60,000 women. The assay
will be distributed exclusively by bioMerieux with its proprietary
NucliSENS EasyQ(R) system worldwide, except for the Nordic countries, the
UK, Australia and New Zealand. bioMerieux will pay NorChip upfront fees,
milestone payments, as well as royalties on sales.



About Human Papillomavirus and cervical cancer



Human Papillomavirus is a group of sexually transmitted viruses that
may be related to the development of cervical cancer. More than 80% of all
adults will have at least one infection with HPV during their lifetime.
However, nearly all these infections may be considered as the "cervical
flu," and have nothing to do with cervical cancer risk. The development of
cervical cancer is related to oncogenic proteins produced by transformed
cells in the woman's cervix. These cells are influenced by certain genetic
sequences from a limited group of HPV-viruses and may develop into cervical
cancer over a period of 10- 25 years. Oncogenic proteins related to the
five HPV-types 16, 18, 31, 33, and 45 are related to more than 97% of all
cases of HPV-induced cervical cancer in Europe. The NorChip technology
detects the oncogenic expression, and is therefore an accurate and
cost-effective test for cervical cancer prevention.
















About NorChip



NorChip is a research-based company developing and marketing medical
products for clinical diagnosis. NorChip aims to provide people in all
parts of the world with essential health-related information and thereby
increase people's quality of life. NorChip has developed and sells the
PreTect(R) HPV- Proofer assay, the world's first diagnostic test to reveal
early oncogenic activity in cervical cells. This technology provides over
90% sensitivity against cervical cancer and pre-stages of cervical cancer
and is the world's most accurate and cost-effective test for preventing
cervical cancer.



NorChip - Providing people a better life



About bioMerieux



bioMerieux is a leading international diagnostics group that
specializes in the field of in vitro diagnostics for clinical and
industrial applications. bioMerieux designs, develops, manufactures and
markets systems (i.e. reagents, instruments and software) used in:


- Clinical applications: the diagnosis of infectious diseases such as
hepatitis, HIV, tuberculosis and respiratory illnesses, as well as
pathologies such as cardiovascular diseases and cancer, based on the
analysis of biological samples (such as blood, saliva or urine); and


- Industrial applications: the microbiological analysis of food,
environments (such as water and air), surfaces and pharmaceutical and
cosmetic products, based on the analysis of product or environmental
samples.



In 2006, bioMerieux sales reached 1,037 million euros. The company is
present in more than 150 countries through 35 subsidiaries and a large
network of distributors, which positions the company well to benefit from
the growth potential of the in vitro diagnostics market.



bioMerieux is listed on the Eurolist of Euronext, Paris (FR0010096479 -
BIM). Other information can be found at biomerieux-usa.


bioMerieux

biomerieux-usa

суббота, 30 июля 2011 г.

Retrial For Human Rights Advocate Chen Guangcheng Ends Without Verdict

The retrial for human rights advocate Chen Guangcheng -- who was arrested in China after attempting to bring a class-action lawsuit against the government for alleged human rights abuses associated with the enforcement of the country's one-child-per-family policy -- ended on Monday with no verdict, the AP/ABC News reports (Ang, AP/ABC News, 11/27). Chen has recorded testimony from men and women in communities in and around China's Linyi province who have experienced forced abortions and sterilizations. Chen in August was sentenced by a court in China's Shandong province to four years and three months in prison for allegedly "willfully damaging property" and "organizing a mob to disturb traffic." An appeals court in Shandong in October ordered the retrial. According to Li Jingsong, one of Chen's attorneys, the Linyi City Intermediate Court overturned the sentence "because the process of the first trial was unfair, and facts and evidence ... were not tenable and did not hold water" (Kaiser Daily Women's Health Policy Report, 11/1).

Trial Proceedings
Chen's attorneys said that despite multiple setbacks local authorities prevented them from presenting a strong defense, the New York Times reports (Kahn, New York Times, 11/27). Chen's attorneys also said there were occasions for optimism during the 10-hour proceedings on Monday despite multiple setbacks, the Washington Post reports. "In the morning, the prosecutor interrupted us all the time, and the judge was always on the prosecutor's side," Li said, adding, "In the afternoon, the prosecutors tried to interrupt us about 20 to 30 times, but this time, the judge mostly denied their objections" (Fan, Washington Post, 11/28). According to the AP/ABC News, Li walked out of the courtroom midway through the proceedings to protest what he said was unfair treatment and interference by local authorities. Two of Li's witnesses could not be found before the trial, and Li said he saw a third, Chen Guanghe, being taken away on Sunday by eight men he believes were police officers in civilian clothing or men with ties to the police, the AP/ABC News reports. Li said he was prevented from collecting evidence and was assaulted on Sunday by a group of 30 people in Dongshigu, China (AP/ABC News, 11/27). Three witnesses -- including Chen's wife, Yuan Weijing, and brother, Chen Guangqing -- were allowed to testify for the defense, and Chen was allowed about 30 minutes to defend himself, the South China Morning News reports (Ma, South China Morning News, 11/28). Yuan said that she was questioned by police on Tuesday, the AP/International Herald Tribune reports (Ang, AP/International Herald Tribune, 11/28). Teng Biao, also one of Chen's attorneys, was detained by the police for about four hours for questioning during the trial. According to Reuters, an unnamed court official said the trial was an "ordinary case," but he declined to provide details (Kang Lim, Reuters, 11/27). A verdict is expected within a month, Li said, adding that he expects the court to uphold the charge of damaging public property, which carries a maximum sentence of seven months (AP/ABC News, 11/27).

"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.

суббота, 23 июля 2011 г.

Is It All In The Head? - Understanding Psychosexual Disorders In Women, UK

A new paper to be published in The Obstetrician & Gynaecologist ( TOG ) reviews existing scientific knowledge of women's sexual dysfunction and examines the different types of recognised psychosexual disorders to increase awareness of these issues amongst doctors.


Sexual dysfunction has been reported in 43% of women and most of these difficulties focus around areas such as desire, arousal, orgasm and sexual pain. A review carried out by the American Psychiatric Association in 1999 expanded these fields to include physical and psychological causes. The existence of non-coital pain disorder was also noted.


It is now widely accepted that responsive desire, triggered by mental and physical arousal, occurs in the majority of women, rather than spontaneous desire, which is less common. These problems are a result of a combination of biological, interpersonal, environmental and psychological factors that impact on a woman's reaction to sex.


The authors recognise that gynaecological conditions and procedures can be distressing for some women. Although overall sexual wellbeing improves after some forms of gynaecological treatment such as a hysterectomy, some women miss the sensations felt before surgery. Negative obstetric experiences such as birth trauma are also known to affect women's sexual response to stimuli. Other forms of treatment, whether drug-based or in the form of radiotherapy, have also been known to affect women's desire.


The common sexual disorders are:


- Sexual desire disorder - usually a result of personal experiences and cultural programming. Depression can have an effect and hormonal treatment is usually used.


- Sexual arousal disorder - a combination of physical and psychological factors. Pre-existing conditions such as diabetes or previous injuries may have an impact. Pharmacological treatment is used alongside physical treatment such as the use of lubricants.


- Orgasmic disorder - more common among younger women. Cognitive behavioural therapy, sexual education and Kegel exercises often used as treatment.


- Sexual pain disorder - (Dyspareunia) a physical condition that occurs when pain is experienced during penetration, usually a result of muscle tension in the vulva or pelvis. It is sometimes associated with dermatological conditions such as psoriasis and sometimes misdiagnosed as recurrent thrush. Vaginismus is also a physical condition but often a result of phobias caused typically by childhood sexual trauma or a background of severely oppressive religious orthodoxy. A combination of counselling and physical treatment such as the use of vaginal trainers has been known to help patients.















The authors recommend that doctors should be sympathetic to the sensitive nature of these sexual problems. They must have detailed notes of the woman's medical, pain, psychological and sexual history and need to have an understanding of the psychosexual function and the ability to communicate about these matters in a non-judgemental, non-intrusive manner.


Clinicians should also have some understanding of non-verbal communications in order to identify when women are feeling tense and anxious, and if they are displaying behaviours (such as complaining about pelvic pain, distress about having periods or disassociation during the time of genital examination) that reveal an underlying problem. A multidisciplinary approach is recommended and clinicians should have access to vulval pain clinics and a psychologist, therapist or psychosexual medical specialist, in order to provide good quality care.


Dr Catherine Coulson, from the Department of Reproductive Medicine at St Michael's Hospital in Bristol, who co-authored the paper said " Desire disorders become more common as women get older and are affected to an extent by hormones. Loss of desire may be experienced at the menopause regardless of age and is often reported after a surgically induced menopause.


"Similarly, a loss of desire may be a result of a previous experience of pain, guilt, shame, embarrassment or awkwardness. As a result, the woman may have learned to keep a tight rein on her emotions generally to avoid conflict or to suppress her anger.


"Some sexual problems need more time and expertise than is available in a general gynaecology clinic. However listening to the patient in an active way, understanding the exact nature of the problem and its impact on the woman and her relationship, if she has one, can in itself be therapeutic."


Professor Neil McClure, TOG editor-in-chief said, "There is much cross-over in the study of women's sexual dysfunction between medicine and psychology. As clinicians, we need to understand the complex layers of physical, psychological and social reasons why women sometimes have these difficulties if we are to provide women with the care they need.


"What is important is that gynaecologists have the appropriate training and skills to manage women presenting with psychosexual problems and that they are always vigilant in their identification."


The Obstetrician & Gynaecologist ( TOG ) is published quarterly and is the Royal College of Obstetricans and Gynaecologists' (RCOG) medical journal for continuing professional development. TOG is an editorially independent, peer reviewed journal aimed at providing health professions with updated information about scientific, medical and clinical developments in the specialty of obstetrics and gynaecology.

Reference


Coulson C, Crowley T. Current thoughts on psychosexual disorders in women. The Obstetrician & Gynaecologist 2007: 9 :217-222.

rcog

суббота, 16 июля 2011 г.

Accounting For Temporal Changes In Health Practices When Calibrating Models

The introduction and subsequent widespread use of the Papanicolaou (Pap) test has considerably reduced rates of cervical cancer in the last 50 years. The study entitled, "Calibrating Longitudinal Models to Cross-Sectional Data: The Effect of Temporal Changes in Health Practices," published in Value in Health, and performed by Douglas Taylor and colleagues, found that a considerable bias was introduced in the results of a cervical disease model when historical changes in cervical screening practices were not considered in the calibration process.


According to study author Dr. Milton Weinstein, "This study demonstrates that it is important for calibrated health care models to take into account temporal changes in clinical practices in order to more accurately reflect the effects of new interventions."


Source:

ISPOR

суббота, 9 июля 2011 г.

Time To Transplant Bridged For More Women Using Smaller Heart Pump

A small, implantable device that helps the heart pump blood works equally well for men and women but may benefit twice as many women awaiting transplants, researchers reported at the American Heart Association's Scientific Sessions 2007.



"The fact that we have a technology where the outcomes in women are equal to men is important," said Roberta C. Bogaev, M.D., lead author of the study and medical director of heart failure and cardiac transplantation at the Texas Heart Institute in Houston. "Historically, because of their size, such devices have been unavailable to women of small stature. Now that we have a pump about the size of a D battery, it will allow us to expand mechanical circulatory support options to more women."



The device, called The HeartMate II, is an implantable left ventricular assist device (LVAD) that supports the heart for patients with severe congestive heart failure and minimal medical options. It's powered by a battery-run unit worn outside the body.



The U. S. Food and Drug Administration is reviewing the manufacturer's request to approve use of the experimental pump in heart failure patients.



The phase II study participants received the LVAD as a "bridge" to keep them alive until a donor heart became available.



The trial involved 231 patients with advanced heart failure, 52 (23 percent) of them women, who were treated at 40 heart transplant centers in the United States.



"This is the first trial to include this many women," said Bogaev, who is also assistant professor of medicine at Baylor College of Medicine in Houston. "Most ventricular assist device trials before HeartMate II enrolled less than 10 percent women."



Women in the study were 20 to 69 years old (average age 56). The men were 17 to 68 (average age 54). The cause of heart failure was more likely to be coronary artery disease in men (43 percent) than in women (31 percent). The women tended to have suffered a weakened heart because of pregnancy, cancer chemotherapy, a viral infection, or unknown cause of heart failure.



Some study participants -- six at the Texas Heart Institute alone -- recovered sufficient pumping power to have the device removed and did not require a transplant operation. This can happen when heart failure patients are treated with a ventricular assist device and have a potentially reversible cause of the heart failure.



"They are not sitting in a recliner at home," Bogaev said. "These patients have been able to leave the hospital and return to their normal active life due to the support this device offers."



Among the study's findings:



* For the 194 patients with six-month follow-up data, survival was almost the same for both genders -- 79.5 percent for women and 80.6 percent for men -- among those who had undergone a heart transplant, had their LVAD removed after regaining ventricular function, or remained on the device.
















* The average time patients remained on the pump was 175 days for women (range -- 8 to 667 days) and 130 days for men (range -- 0 to 693 days).



* A weakening of contraction in the heart's right ventricle, which required temporarily implanting a right ventricular device, occurred in 10 patients, 9 percent of the women and 4 percent of the men. "What that suggests to me is that the women enrolled in this trial may have presented with more advanced heart failure," Bogaev said. "Now that we have the option of a smaller device, physicians should not delay in referring women for ventricular assist devices."



* Six patients, 3.3 percent women and 2.2 percent men, experienced strokes within two days after their surgery. Twelve patients (13.6 percent women and 5 percent men) suffered strokes more than two days after surgery. "Since this is a small number of patients, we will need to continue to follow patients with this device to determine if this is a significant finding between men and women," Bogaev said.



* After three months of LVAD support, 76 percent of women and 57 percent of men had increased the distance they could walk in six minutes by more than 200 meters (about 656 feet).



* At three months, 84 percent of women and men had New York Heart Association Class I and Class II heart failure symptoms (no or slight limitations on physical activity). When they entered the trial, all patients had Class IV symptoms (unable to carry out any physical activity without discomfort).



* The 11 smallest patients receiving the LVAD were females and all of them remained alive at the six-month follow-up.



"This smaller device is well suited for women and small men, who previously have not had the option of mechanical circulatory support," Bogaev said. "At the Texas Heart Institute, we've been able to increase the percentage of women who benefit from LVADs from 7 percent to 37 percent."







Co-authors are Leway Chen, M.D.; Stuart D. Russell, M.D.; Joseph G. Rogers, M.D.; David J. Farrar, Ph.D.; and Stephanie A. Moore, M.D.



Thoratec Corp., the device manufacturer, funded the study. Dr. Farrar is the company's vice president for research and scientific affairs. The other co-authors are consultants and serve on an advisory board to Thoratec. Statements and conclusions of study authors that are presented at American Heart Association scientific meetings 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: Karen Astle

American Heart Association