Young women would accept age-based screening for the sexually transmitted infection chlamydia, but would want this test to be offered to everyone, rather than to people 'singled out' according to their sexual history.
In the study, published in the BioMed Central open access journal BMC Infectious Diseases, the Australian women interviewed did not like discussing their sex lives with their GPs. Some said they would even lie about how many sexual partners they had had if asked. In response to these findings, the study authors suggest that a detailed sexual history should not be required before testing women for chlamydia.
Chlamydia is Australia's and the UK's most commonly diagnosed sexually transmitted infection (STI). It is most prevalent in the under-25s and can have serious long-term health consequences, including causing infertility in women.
A team comprising three doctors, a sociologist and an epidemiologist at the University of Melbourne, Australia aimed to find out what young Australian women thought about the introduction of chlamydia screening into general practice. The researchers interviewed 24 sexually active women aged 16 to 24 who attended one of a sample of general practices. Equal numbers of women from rural, regional and urban areas were questioned.
In contrast to previous research, which suggests women are not concerned about giving information about their sexual history in the context of a family planning or sexual health clinic, interviewees were reluctant to provide such a history to their GPs. This is a new finding which raises the question of whether a sexual history is really necessary when screening for chlamydia.
The authors acknowledge that it is important for young women to understand that chlamydia is an STI and that sexual partners should be notified if someone tests positive. However, they said that chlamydia testing should be destigmatised. "In general practice the offer [of a chlamydia test] may seem to come 'out of the blue'" says Natasha Pavlin, who coordinated the study. "The importance of normalising the offer of chlamydia testing, so that individual women do not feel singled out, cannot be overemphasised."
1. Take the sex out of STI screening! Views of young women on implementing chlamydia screening in General Practice
Natasha L Pavlin, Rhian Parker, Christopher K Fairley, Jane M Gunn and Jane Hocking
BMC Infectious Diseases (in press)
Article available at the journal website:
biomedcentral/bmcinfectdis/
All articles are available free of charge, according to BioMed Central's open access policy.
2. BMC Infectious Diseases is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of infectious and sexually transmitted diseases in humans, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Infectious Diseases (ISSN 1471-2334) is indexed/tracked/covered by PubMed, MEDLINE, CAS, Scopus, EMBASE, Thomson Scientific (ISI) and Google Scholar.
3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Charlotte Webber
BioMed Central
вторник, 28 июня 2011 г.
воскресенье, 26 июня 2011 г.
Women With Higher Levels Of DHEAS Have Better Cognitive Function
Women with naturally higher levels of the hormone precursor DHEAS were found to have better cognitive function than women with lower levels, according to a new study appearing in the March issue of the Journal of Clinical Endocrinology & Metabolism (JCEM). The study revealed that cognitively intact women with higher circulating levels of DHEA (dehydroepiandrosterone) in the form of DHEA sulfate (DHEAS) performed better on tests of executive function, concentration, and working memory.
"This study provides the first evidence that DHEAS is favorably associated with cognitive function," said Dr. Susan Davis of the Monash University in Victoria, Australia, and lead author of the study. "My colleagues and I found that circulating DHEAS was significantly positively associated with a higher score for a test of executive function, and in the areas of simple concentration and working memory higher DHEAS levels were positively associated with higher scores for women with at least 12 years of education."
DHEA is a steroid precursor, which means that it is converted in the body to steroid hormones such as testosterone and estrogen. It is the most abundant circulating sex steroid in women.
Previous studies suggest that DHEA and DHEAS may have neuroprotective effects. These studies also suggest that the decline in the production of these steroids with healthy aging may contribute to neuronal dysfunction and degeneration, and thus cognitive decline.
Maintenance of cognitive function in elderly women is influenced by a number of health variables, including diabetes, hypertension, and smoking. Other studies have reported association between these factors and progression to dementia in elderly individuals. "In our study we were specifically interested in the associations between cognitive function and DHEAS, social circumstances, and leisure activities," said Dr. Davis.
For this study, "Endogenous Androgen Levels in Women across the Adult Life Span," 295 women, ages 21 to 77 (mean age 55), were recruited from an Australian community-based dataset. Each participant underwent a battery of tests known to measure a wide range of cognitive abilities, including verbal, visual, spatial and working memory, attention and concentration, speed, and accuracy. Women were excluded if they reported any health condition that might potentially adversely affect cognitive function.
In addition to the DHEA and DHEAS findings, the study also found that activities such as living with other people, doing crosswords, and playing a musical instrument were positively associated with cognitive performance. Circulating DHEAS levels were not associated in this study with performance on tests of verbal and non-verbal learning and retention or focused attention.
The researchers speculate that there may be a number of explanations for their findings, including direct action of DHEA and DHEAS, DHEAS being a marker of androgen and estrogen production in women, or simply DHEA and DHEAS levels being markers of general good health.
Although DHEA and DHEAS levels decline in both men and women with age, testosterone levels are generally well maintained in men. In contrast, testosterone levels in women are only a fraction of those found naturally in men. This may mean that even small differences in adrenal pre-androgen production may make a substantial difference to a woman's overall androgen profile.
It should be noted that DHEA, which is commonly sold as a dietary supplement in the United States, is not available over the counter in Australia. The researchers stress that they found no evidence that taking a DHEA supplement would be at all beneficial.
Other researchers involved in this study include Sonal M. Shah, Dean P. McKenzie, Jayashri Kulkarni, Sonia L. Davison, and Robin J. Bell, all of the Monash University.
"This study provides the first evidence that DHEAS is favorably associated with cognitive function," said Dr. Susan Davis of the Monash University in Victoria, Australia, and lead author of the study. "My colleagues and I found that circulating DHEAS was significantly positively associated with a higher score for a test of executive function, and in the areas of simple concentration and working memory higher DHEAS levels were positively associated with higher scores for women with at least 12 years of education."
DHEA is a steroid precursor, which means that it is converted in the body to steroid hormones such as testosterone and estrogen. It is the most abundant circulating sex steroid in women.
Previous studies suggest that DHEA and DHEAS may have neuroprotective effects. These studies also suggest that the decline in the production of these steroids with healthy aging may contribute to neuronal dysfunction and degeneration, and thus cognitive decline.
Maintenance of cognitive function in elderly women is influenced by a number of health variables, including diabetes, hypertension, and smoking. Other studies have reported association between these factors and progression to dementia in elderly individuals. "In our study we were specifically interested in the associations between cognitive function and DHEAS, social circumstances, and leisure activities," said Dr. Davis.
For this study, "Endogenous Androgen Levels in Women across the Adult Life Span," 295 women, ages 21 to 77 (mean age 55), were recruited from an Australian community-based dataset. Each participant underwent a battery of tests known to measure a wide range of cognitive abilities, including verbal, visual, spatial and working memory, attention and concentration, speed, and accuracy. Women were excluded if they reported any health condition that might potentially adversely affect cognitive function.
In addition to the DHEA and DHEAS findings, the study also found that activities such as living with other people, doing crosswords, and playing a musical instrument were positively associated with cognitive performance. Circulating DHEAS levels were not associated in this study with performance on tests of verbal and non-verbal learning and retention or focused attention.
The researchers speculate that there may be a number of explanations for their findings, including direct action of DHEA and DHEAS, DHEAS being a marker of androgen and estrogen production in women, or simply DHEA and DHEAS levels being markers of general good health.
Although DHEA and DHEAS levels decline in both men and women with age, testosterone levels are generally well maintained in men. In contrast, testosterone levels in women are only a fraction of those found naturally in men. This may mean that even small differences in adrenal pre-androgen production may make a substantial difference to a woman's overall androgen profile.
It should be noted that DHEA, which is commonly sold as a dietary supplement in the United States, is not available over the counter in Australia. The researchers stress that they found no evidence that taking a DHEA supplement would be at all beneficial.
Other researchers involved in this study include Sonal M. Shah, Dean P. McKenzie, Jayashri Kulkarni, Sonia L. Davison, and Robin J. Bell, all of the Monash University.
суббота, 25 июня 2011 г.
Study Compares Antiretroviral Treatments Among HIV-Positive Mothers Who Received Nevirapine During Labor
A recent review of a clinical study funded by NIH comparing antiretroviral treatment regimens that contained either nevirapine or ritonavir-boosted lopinavir found that ritonavir/ lopinavir is more effective than nevirpaine among HIV-positive women who previously took a single-dose of nevirapine to prevent mother-to-child HIV transmission, South Africa's Business Day reports (Kahn, Business Day, 11/6). The study, called Optimal Combination Therapy after Nevirapine Exposure, has two purposes: to determine which of the two antiretroviral regimens is more effective for women who previously took single-dose nevirapine to prevent MTCT; and to examine whether taking single-dose nevirapine to prevent MTCT during labor subsequently compromises the effectiveness of nevirapine as a component of therapy for HIV-positive mothers (NIAID bulletin, 1028).
The study included 745 women in seven African countries and compared two antiretroviral regimens -- nevirapine, emtricitabine and tenofovir, or lopinavir-boosted ritonavir, emtricitabine and tenofovir -- in women who received nevirapine during labor and those who did not. According to Business Day, a routine interim review of the trial by an independent data safety monitoring board on Oct. 6 found that women who had nevirapine-resistant strains of HIV fared better if they were put on a regimen that did not contain the drug. Thirty-eight percent of the women who had developed resistance and were treated with a nevirapine-based regimen either died or failed to suppress the virus, while all of the women who had nevirapine-resistant strains of HIV but received a regimen containing lopinavir-boosted ritonavir were alive and suppressing the virus.
Francesca Conradie, a researcher from the University of the Wiwatersrand Clinical HIV Research Unit, said, "I'm not saying nevirapine should not have been given to these women -- it was the best we had at the time. What we can do now is protect nevirapine (to ensure it can be safely used in their subsequent treatment)," she said. According to Conradie, women who received nevirapine during childbirth and are now being treated with nevirapine-based regimen should be closely monitored to make sure the drugs are effectively suppressing HIV. They also should be switched to Kaletra -- known generically as lopinavir/ritonavir -- if they show signs of resistance, she said. "The longer you leave them on a failing regimen, the greater the risk that they will become resistant to all the drugs they are taking," Conradie added.
Business Day reports research is continuing into the efficacy of nevirapine and lopinavir-boosted ritonavir in women with no prior exposure to nevirapine (Business Day, 11/6).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation.? All rights reserved.
View drug information on Kaletra Capsules and Oral Solution.
The study included 745 women in seven African countries and compared two antiretroviral regimens -- nevirapine, emtricitabine and tenofovir, or lopinavir-boosted ritonavir, emtricitabine and tenofovir -- in women who received nevirapine during labor and those who did not. According to Business Day, a routine interim review of the trial by an independent data safety monitoring board on Oct. 6 found that women who had nevirapine-resistant strains of HIV fared better if they were put on a regimen that did not contain the drug. Thirty-eight percent of the women who had developed resistance and were treated with a nevirapine-based regimen either died or failed to suppress the virus, while all of the women who had nevirapine-resistant strains of HIV but received a regimen containing lopinavir-boosted ritonavir were alive and suppressing the virus.
Francesca Conradie, a researcher from the University of the Wiwatersrand Clinical HIV Research Unit, said, "I'm not saying nevirapine should not have been given to these women -- it was the best we had at the time. What we can do now is protect nevirapine (to ensure it can be safely used in their subsequent treatment)," she said. According to Conradie, women who received nevirapine during childbirth and are now being treated with nevirapine-based regimen should be closely monitored to make sure the drugs are effectively suppressing HIV. They also should be switched to Kaletra -- known generically as lopinavir/ritonavir -- if they show signs of resistance, she said. "The longer you leave them on a failing regimen, the greater the risk that they will become resistant to all the drugs they are taking," Conradie added.
Business Day reports research is continuing into the efficacy of nevirapine and lopinavir-boosted ritonavir in women with no prior exposure to nevirapine (Business Day, 11/6).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation.? All rights reserved.
View drug information on Kaletra Capsules and Oral Solution.
Bone Thinning Drug Raloxifene As Effective As Tamoxifen In Reducing Postmenopausal Women's Risk Of Breast Cancer, NCI Study Says
The bone thinning drug raloxifene is as effective as the breast cancer prevention drug tamoxifen in reducing breast cancer risk for postmenopausal women already at an increased risk of developing the disease and is less likely to cause serious complications, according to initial results of a National Cancer Institute-sponsored study released on Monday, the Washington Post reports (Stein, Washington Post, 4/18). FDA in 1998 approved tamoxifen -- sold under the brand name Nolvadex by AstraZeneca -- to reduce breast cancer risk after a study showed it decreased the likelihood of women developing the disease by 50%. It is the only drug the agency has approved for such use, the Detroit News reports. Raloxifene, sold under the brand name Evista and made by Eli Lilly, is FDA approved for use as a preventive drug for osteoporosis and bone thinning but not for breast cancer (Kozlowski, Detroit News, 4/18). Both drugs are designed to block estrogen -- which stimulates many breast cancer tumors -- and both have comparable side-effect risks, including an increased risk of blood clot, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 4/18). Eli Lilly plans to seek FDA approval for use of raloxifene to prevent breast cancer, the AP/Akron Beacon Journal reports (Neergaard, AP/Akron Beacon Journal, 4/17).
Study Results
For the study, researchers at the NCI-sponsored National Surgical Adjuvant Breast and Bowel Project enrolled 19,747 postmenopausal women who had an average age of 58 and an average risk of 4% of developing breast cancer, compared with a 1.6% risk for the total population in the same age range (Maugh, Los Angeles Times, 4/18). Researchers determined each woman's breast cancer risk through an analysis of a questionnaire available at breastcancerprevention, and the participants randomly were assigned to take tamoxifen or raloxifene for five years (Grady, New York Times, 4/18). The study, which followed the participants for an average of four years, finds that both drugs reduced breast cancer risk by about 50%, with 167 of the 9,745 women in the raloxifene group developing breast cancer and 163 of the 9,726 women in the tamoxifen group developing the disease (NCI release, 4/17). Participants in the raloxifene group had a higher number of precancerous lesions than women in the tamoxifen group, Reuters reports (Fox, Reuters, 4/17). The study also finds that women in the raloxifene group developed 36% fewer uterine cancers, 29% fewer blood clots and were less likely to develop cataracts requiring surgery or have night sweats, hot flashes and gynecological irritation than women in the tamoxifen group (Bor, Baltimore Sun sidebar, 4/18). The cataract difference was statistically significant, but the differences in uterine cancers, blood clots and menopausal symptoms were not statistically significant, the Times reports (New York Times, 4/18). "This is really good news for women," Leslie Ford, a study co-author and NCI researcher, said, adding that raloxifene is a "drug that's already used by 500,000 women for treatment and prevention of osteoporosis, and now we have an additional benefit" (Goldstein, Miami Herald, 4/18). The researchers plan to present additional data from the study at the American Society for Clinical Oncology meeting in June (Collins, Salt Lake City Deseret Morning News, 4/18).
Media Coverage
Several broadcast programs reported on the study:
ABCNews' "World News Tonight": The segment includes comments from Mary Daly, director of the Margaret Dyson Family Risk Assessment Program and director of the Cancer Prevention and Control Program at the Fox Chase Cancer Center; Judy Garber, director of cancer risk and prevention in the Department of Adult Oncology at the Dana-Farber Cancer Institute; Norman Wolmark, chair of NSABP; and a woman who participated in the study (McKenzie, "World News Tonight," ABCNews, 4/17).
CBS' "Evening News": The segment includes comments from Ford and a woman who participated in the study (Kaledin, "Evening News," CBS, 4/17). The complete segment is available online in RealPlayer.
NBC's "Nightly News": The segment includes comments from Ford, Wolmark and a woman who participated in the study (Bazell, "Nightly News," NBC, 4/17). The complete segment is available online in Windows Media.
NPR's "All Things Considered": The segment includes comments from Garnet Anderson, faculty member at the Fred Hutchinson Cancer Research Center; Joy Melnikow, a professor of family and community medicine at the University of California-Davis; Wolmark; and women who participated in the study (Palca, "All Things Considered," NPR, 4/17). A transcript of the segment is available online. The complete segment is available online in RealPlayer.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Evista; Nolvadex.
Appeals Court Judge Wood Draws Notice As Possible Supreme Court Pick
Seventh Circuit Appeals Court Judge Diane Wood is attracting speculation that she could be President Obama's Supreme Court nominee if Justice John Paul Stevens retires this year, USA Today reports.
Stevens, who will turn 90 in April, has not chosen a full roster of legal clerks for the court term beginning in October, prompting observers to predict a pending retirement. Stevens recently told the New Yorker that he would decide in the next month whether to retire. Wood, Solicitor General Elena Kagan and Department of Homeland Security Secretary Janet Napolitano all are considered top contenders for a Supreme Court vacancy, in part because President Obama interviewed each of them before nominating Justice Sonia Sotomayor to fill retired Justice David Souter's seat last year.
On Tuesday, Wood spoke about her legal experiences during a talk hosted by the American Constitution Society. Thomas Goldstein -- founder of SCOTUSblog and a regular advocate before the Supreme Court -- introduced Wood at Tuesday's event, saying she would be the next Supreme Court justice "if the stars align" and Democrats prevail.
Goldstein in February speculated that Kagan -- the nation's first female solicitor general and a former dean of Harvard Law School -- may be a more likely nominee because of her reputation as less liberal than Wood.
According to USA Today, Wood, who joined the appeals court in 1995, "has been an unswerving voice on the left, including in support of abortion rights," an issue that she did not directly address on Tuesday.
In her talk, Wood described her role as one of only two women on the circuit court during the 1990s and her experiences with lawyers who had "a little trouble" with a female presence on the bench (Biskupic, USA Today, 3/24).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
Japanese Government To Consider Supporting Assisted Reproductive Technologies, Surrogate Births, Officials Say
The Japanese government will consider potential legislation to support assisted reproductive technologies, including surrogate pregnancies, for infertile couples, Chief Cabinet Secretary Yasuhisa Shiozaki said during a news conference on Monday, the Kyodo News/Yahoo! News reports. However, surrogate births raise many "very difficult" issues involving couples, children born by the procedure and the general public, according to Prime Minster Shinzo Abe (Kyodo News/Yahoo! News, 10/16). Japan's "conventional legal interpretation" says that the woman who delivers an infant is the child's mother, AFP/Yahoo! News reports. The Ministry of Health, Labour and Welfare's council in 2001 after the first surrogate birth was reported in the country called for a ban on the practice. According to AFP/Yahoo! News, lawmakers have blocked legislation that would implement a ban, but the Japan Society of Obstetrics of Gynecology in 2003 barred surrogate births. "Rather than locking in the council's direction as law, I think we will explore other directions," Health Minister Hakuo Yanagisawa said at a news conference on Tuesday, adding, "We are now seeing rising public opinion in support of [surrogacy]." Sanae Takaichi, state minister in charge of gender equality and population, said, "The discussion is highly welcome, but it is extremely difficult to judge whether surrogate birth can be encouraged." Justice Minister Jinen Nagase said, "We have not decided whether we should accept this medical procedure. If we decide on it at this stage, it will only cause confusion" (Hiyama, AFP/Yahoo! News, 10/17).
"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.
"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.
Research Suggests That Lipofilling May Be Safe During Conservation Treatment For Breast Cancer
A new study has gone some way to answering the question about whether or not a technique called lipofilling is safe for women who are having their breasts reconstructed after surgery for breast cancer.
Lipofilling involves taking some fat from another area of a woman's body, such as her abdomen, and using it to fill in small defects or asymmetry that may occur during breast reconstruction. However, until now, there has been a lack of evidence as to whether or not the technique could trigger a recurrence of the original breast cancer, and so plastic surgeons have not been able to advise patients fully on the pros and cons of lipofilling, despite the fact that it has been used for over 30 years.
Now, a study published in the cancer journal Annals of Oncology today [1] suggests that lipofilling seems to be a safe procedure for breast cancer patients, although the authors say that longer follow-up and more research is required in order to confirm their findings.
The researchers analysed data on 321 women who had been operated on for primary breast cancer at the European Institute of Oncology (IEO) in Milan, Italy, between 1997 and 2008, and who had then had lipofilling as part of their breast reconstruction. These women were matched with double the number (642) of women who had also had surgery for primary breast cancer, but who did not undergo lipofilling.
The researchers followed up the women for an average of 56 months from the time of the primary surgery and 26 months from the lipofilling. They found that eight women in the lipofillling group and 19 women in the control group had a local recurrence of their cancer - a difference that was not statistically significant. When they analysed the data to look specifically at recurrences in women with non-invasive cancer (in situ cancer) they found there were three cases of recurrence in the lipofilling group and none in the control group; this was statistically significant, but may have been affected by the very small numbers involved, the short follow-up and the fact that there were no recurrences in the control group despite previous research suggesting there should be an average recurrence rate of over two percent during this period of time. "This indicates there might have been some bias in the selection of the women with non-invasive breast cancer in the control group," explained one of the authors, Professor Jean Yves Petit.
Prof Petit, from the Division of Plastic Surgery at the IEO in Milan, said: "To date, only a few studies have focused on cancer recurrences after lipofilling, and this is the first case-control study to investigate the question and the first publication to show the safety of the procedure. Our overall results do not find any difference in recurrences between the women in the lipofilling and control groups. However, it is still too early in the follow-up to be able to draw any definitive conclusions. We urge other teams working in the same field to gather their own results concerning local recurrences after lipofilling in breast conservation treatment."
This study is important because other, experimental work in the laboratory has shown that fatty tissue is capable of producing growth factors that can trigger cancer cells to multiply. This raised the question of whether this might happen in humans.
"Work by other researchers has shown that secretions from transplanted fat tissues can stimulate angiogenesis [the formation of new blood vessels] and cell growth," said Prof Petit. "In the laboratory the interaction between the tumour and stromal cells - the connective tissue cells found in any organ - has the potential to induce the reappearance of cancer by fuelling dormant breast cancer cells in the tumour bed, for example through angiogenesis and growth factor induction. However, until now, there has been a lack of translational research to prove whether or not this might happen in the clinic when lipofilling is used for breast cancer patients. Our study suggests that the procedure is safe for these women."
[1] "Locoregional recurrence risk after lipofilling in breast cancer patients".
Annals of Oncology
doi:10.1093/annonc/mdr158
Lipofilling involves taking some fat from another area of a woman's body, such as her abdomen, and using it to fill in small defects or asymmetry that may occur during breast reconstruction. However, until now, there has been a lack of evidence as to whether or not the technique could trigger a recurrence of the original breast cancer, and so plastic surgeons have not been able to advise patients fully on the pros and cons of lipofilling, despite the fact that it has been used for over 30 years.
Now, a study published in the cancer journal Annals of Oncology today [1] suggests that lipofilling seems to be a safe procedure for breast cancer patients, although the authors say that longer follow-up and more research is required in order to confirm their findings.
The researchers analysed data on 321 women who had been operated on for primary breast cancer at the European Institute of Oncology (IEO) in Milan, Italy, between 1997 and 2008, and who had then had lipofilling as part of their breast reconstruction. These women were matched with double the number (642) of women who had also had surgery for primary breast cancer, but who did not undergo lipofilling.
The researchers followed up the women for an average of 56 months from the time of the primary surgery and 26 months from the lipofilling. They found that eight women in the lipofillling group and 19 women in the control group had a local recurrence of their cancer - a difference that was not statistically significant. When they analysed the data to look specifically at recurrences in women with non-invasive cancer (in situ cancer) they found there were three cases of recurrence in the lipofilling group and none in the control group; this was statistically significant, but may have been affected by the very small numbers involved, the short follow-up and the fact that there were no recurrences in the control group despite previous research suggesting there should be an average recurrence rate of over two percent during this period of time. "This indicates there might have been some bias in the selection of the women with non-invasive breast cancer in the control group," explained one of the authors, Professor Jean Yves Petit.
Prof Petit, from the Division of Plastic Surgery at the IEO in Milan, said: "To date, only a few studies have focused on cancer recurrences after lipofilling, and this is the first case-control study to investigate the question and the first publication to show the safety of the procedure. Our overall results do not find any difference in recurrences between the women in the lipofilling and control groups. However, it is still too early in the follow-up to be able to draw any definitive conclusions. We urge other teams working in the same field to gather their own results concerning local recurrences after lipofilling in breast conservation treatment."
This study is important because other, experimental work in the laboratory has shown that fatty tissue is capable of producing growth factors that can trigger cancer cells to multiply. This raised the question of whether this might happen in humans.
"Work by other researchers has shown that secretions from transplanted fat tissues can stimulate angiogenesis [the formation of new blood vessels] and cell growth," said Prof Petit. "In the laboratory the interaction between the tumour and stromal cells - the connective tissue cells found in any organ - has the potential to induce the reappearance of cancer by fuelling dormant breast cancer cells in the tumour bed, for example through angiogenesis and growth factor induction. However, until now, there has been a lack of translational research to prove whether or not this might happen in the clinic when lipofilling is used for breast cancer patients. Our study suggests that the procedure is safe for these women."
[1] "Locoregional recurrence risk after lipofilling in breast cancer patients".
Annals of Oncology
doi:10.1093/annonc/mdr158
Chances Of Pregnancy Diminish After Multiple Attempts Using Same Fertility Treatment, Study Finds
The probability that a woman will become pregnant decreases after two or three failed attempts using the same fertility treatment, according to a new study in Fertility and Sterility that offers insight into how many treatment cycles doctors should offer before trying another tactic, Reuters reports.
For the study -- which involved 408 couples at eight infertility centers -- researchers at the University of California-San Francisco analyzed the success rates of three infertility treatments: fertility drugs, intrauterine insemination and in-vitro fertilization. Of the participating couples, 21% did not undergo any of the three treatments. The total pregnancy rate across the group was 28% over 18 months.
Couples who underwent one to two cycles of fertility-drug treatment had a pregnancy rate of 85%, while IUI couples and IVF couples had success rates of 71% and 59%, respectively, after one attempt. However, according to Reuters, "the advantage of each of the three treatments declined after a certain number of attempts." For example, six couples who received three or more rounds of fertility drugs had a pregnancy rate of 29%, while 35% of the 52 couples who attempted IVF three or more times achieved pregnancy.
The findings show that individual fertility treatments have "diminishing success" over time, according to lead author James Smith, an assistant professor of urology at UCSF. Smith suggested that "[i]f couples are not getting pregnant after several cycles of each, a change to a different strategy is probably warranted" (Norton, Reuters, 8/4).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
Iron-Regulating Protein Is Strong Predictor Of Breast Cancer Prognosis
A new study by researchers at Wake Forest University Baptist Medical Center (WFUBMC) may soon help to spare some women with breast cancer from having to undergo invasive and toxic treatments for their disease.
Investigators found that low levels of ferroportin, the only known protein to eliminate iron from cells, are associated with the most aggressive and recurring cancers. The finding suggests that testing for ferroportin levels in women with breast cancer may one day help doctors to more accurately predict whether their patients' cancer will return. It may also help some women with high levels of the protein to avoid invasive or toxic treatments such as chemotherapy.
The study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), of the National Institutes of Health (NIH), appears in the online version of the journal Science Translational Medicine.
"Ferroportin expression may help predict whether women who have had breast cancer will relapse or not," said Frank M. Torti, M.D., M.P.H., director of the Comprehensive Cancer Center at WFUBMC, senior author on the paper and co-lead investigator for the study. The findings also suggest that levels of ferroportin may eventually help guide therapy for breast cancer patients.
"There is a group of high-risk women with breast cancer who have high ferroportin levels and do quite well," Torti said. "We may eventually be able to adjust our treatments so that these patients can avoid chemotherapy and all the side effects that go along with it. The ability to predict which women will be okay without such intense treatment would be a tremendous help."
The findings are the result of a series of experiments by Torti and colleagues at WFUBMC.
Drawing on the hypothesis that iron may be altered in breast cancer and that the alteration might be important in the behavior of the cancer, the researchers first looked at isolated human breast cancer cells and found that there was a significant reduction of ferroportin in the cancerous cells compared to that of normal breast cells.
There are changes in many of the genes and proteins in cancer cells, Torti explained, so the researchers next explored whether the reduction in ferroportin in cancer cells directly contributed to the growth of the cancer or whether it was simply a consequence of the disease. To do this, the researchers artificially increased ferroportin to near normal levels in an aggressive breast cancer cell line in which ferroportin levels were initially very low. Using a mouse model, the researchers watched the growth of tumors formed by these cells, and found that the ones in which the levels of ferroportin had been restored to normal grew more slowly than the tumors formed by cells with depleted levels of the protein.
"The reason for that is simple," explained Suzy V. Torti, Ph.D., an associate professor of biochemistry at Wake Forest Baptist and co-lead investigator on the paper. "In the case of cancer, the ability to remove iron from cells is reduced by the depleted ferroportin levels, and as a result, iron accumulates in cancer cells. Cancer cells require iron, which allows the tumor to grow faster and perhaps become more aggressive. Because ferroportin can remove iron from the cell, when we put the protein back into the cell, the ferroportin removed the cancer's growth stimulus. Our findings suggest that ferroportin is a substantial influence on the behavior of the cancer."
She noted that though the iron at issue acts as a growth stimulus for cancer, the study focused on cellular and not dietary iron or iron supplements. When regulated appropriately, iron is vital to all cell development including that of healthy cells and patients should not change the amount of iron in their diets.
Next, the researchers looked at ferroportin levels in human breast cancer tissue. As predicted, they found that ferroportin levels were lowest in the most aggressive areas of cancer, confirming that the relationship does not only occur in cell culture and isolated breast cancer cells, but also in the actual tissue of women with cancer.
So, the Tortis and their team, including Lance D. Miller, Ph.D., a bioinformatics expert, proceeded to explore four large study databases of breast cancer patients to see if ferroportin levels in human breast cancer were associated with long-term outcomes. The data included gene expression information at the time of diagnosis and multi-year clinical follow-up for more than 800 breast cancer patients from around the world.
"Uniformly, we found that ferroportin levels were a strong predictor of the propensity for a woman's breast cancer to recur," Frank Torti said. "It's a striking prediction. This marker separates women into good and poor prognostic groups independently from any other factors such as tumor size, grade, lymph node status, or other conditions."
The researchers' next step, he added, will be to extend their results to larger populations that include women of various ethnicities and demographics.
"We are excited that we, and our Cancer Center, have made a discovery that not only increases our understanding of the basic biology of breast cancer, but may eventually be directly useful in treating patients," Frank Torti said.
In addition to Frank Torti, Suzy Torti and Miller, co-authors on the study were Zandra K. Pinnix, Ph.D., Wei Wang, Ph.D., Ralph D'Agostino, Jr., Ph.D., Tim Kute, Ph.D., Mark C. Willingham, M.D., Heather Hatcher, Ph.D., Lia Tesfay, M.S., Guangchao Sui, Ph.D., and Xiumin Di, M.S., all of WFUBMC.
Source: Wake Forest University Baptist Medical Center
Investigators found that low levels of ferroportin, the only known protein to eliminate iron from cells, are associated with the most aggressive and recurring cancers. The finding suggests that testing for ferroportin levels in women with breast cancer may one day help doctors to more accurately predict whether their patients' cancer will return. It may also help some women with high levels of the protein to avoid invasive or toxic treatments such as chemotherapy.
The study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), of the National Institutes of Health (NIH), appears in the online version of the journal Science Translational Medicine.
"Ferroportin expression may help predict whether women who have had breast cancer will relapse or not," said Frank M. Torti, M.D., M.P.H., director of the Comprehensive Cancer Center at WFUBMC, senior author on the paper and co-lead investigator for the study. The findings also suggest that levels of ferroportin may eventually help guide therapy for breast cancer patients.
"There is a group of high-risk women with breast cancer who have high ferroportin levels and do quite well," Torti said. "We may eventually be able to adjust our treatments so that these patients can avoid chemotherapy and all the side effects that go along with it. The ability to predict which women will be okay without such intense treatment would be a tremendous help."
The findings are the result of a series of experiments by Torti and colleagues at WFUBMC.
Drawing on the hypothesis that iron may be altered in breast cancer and that the alteration might be important in the behavior of the cancer, the researchers first looked at isolated human breast cancer cells and found that there was a significant reduction of ferroportin in the cancerous cells compared to that of normal breast cells.
There are changes in many of the genes and proteins in cancer cells, Torti explained, so the researchers next explored whether the reduction in ferroportin in cancer cells directly contributed to the growth of the cancer or whether it was simply a consequence of the disease. To do this, the researchers artificially increased ferroportin to near normal levels in an aggressive breast cancer cell line in which ferroportin levels were initially very low. Using a mouse model, the researchers watched the growth of tumors formed by these cells, and found that the ones in which the levels of ferroportin had been restored to normal grew more slowly than the tumors formed by cells with depleted levels of the protein.
"The reason for that is simple," explained Suzy V. Torti, Ph.D., an associate professor of biochemistry at Wake Forest Baptist and co-lead investigator on the paper. "In the case of cancer, the ability to remove iron from cells is reduced by the depleted ferroportin levels, and as a result, iron accumulates in cancer cells. Cancer cells require iron, which allows the tumor to grow faster and perhaps become more aggressive. Because ferroportin can remove iron from the cell, when we put the protein back into the cell, the ferroportin removed the cancer's growth stimulus. Our findings suggest that ferroportin is a substantial influence on the behavior of the cancer."
She noted that though the iron at issue acts as a growth stimulus for cancer, the study focused on cellular and not dietary iron or iron supplements. When regulated appropriately, iron is vital to all cell development including that of healthy cells and patients should not change the amount of iron in their diets.
Next, the researchers looked at ferroportin levels in human breast cancer tissue. As predicted, they found that ferroportin levels were lowest in the most aggressive areas of cancer, confirming that the relationship does not only occur in cell culture and isolated breast cancer cells, but also in the actual tissue of women with cancer.
So, the Tortis and their team, including Lance D. Miller, Ph.D., a bioinformatics expert, proceeded to explore four large study databases of breast cancer patients to see if ferroportin levels in human breast cancer were associated with long-term outcomes. The data included gene expression information at the time of diagnosis and multi-year clinical follow-up for more than 800 breast cancer patients from around the world.
"Uniformly, we found that ferroportin levels were a strong predictor of the propensity for a woman's breast cancer to recur," Frank Torti said. "It's a striking prediction. This marker separates women into good and poor prognostic groups independently from any other factors such as tumor size, grade, lymph node status, or other conditions."
The researchers' next step, he added, will be to extend their results to larger populations that include women of various ethnicities and demographics.
"We are excited that we, and our Cancer Center, have made a discovery that not only increases our understanding of the basic biology of breast cancer, but may eventually be directly useful in treating patients," Frank Torti said.
In addition to Frank Torti, Suzy Torti and Miller, co-authors on the study were Zandra K. Pinnix, Ph.D., Wei Wang, Ph.D., Ralph D'Agostino, Jr., Ph.D., Tim Kute, Ph.D., Mark C. Willingham, M.D., Heather Hatcher, Ph.D., Lia Tesfay, M.S., Guangchao Sui, Ph.D., and Xiumin Di, M.S., all of WFUBMC.
Source: Wake Forest University Baptist Medical Center
Expertise Of Operators Of Pre-Operative Ultrasound Could Be Crucial To Decrease The Number Of Major Operations For Women With Suspected Ovarian Cancer
Improving the quality of pre-operative ultrasound examination (ultrasonography) could lead to a significant decrease in the number of unnecessary major surgical operations done on women with suspected ovarian cancer, who in fact have benign ovarian disease, according to an Article to be published early Online and in the February issue of The Lancet Oncology.
Ultrasonography is routinely used to assess women with various gynaecological symptoms including the detection of adnexal abnormalities*. However, the diagnostic accuracy of ultrasonography for preoperative differentiation between benign and malignant adnexal tumours is variable and depends on the experience and skill of the operator. Studies have shown that gynaecological ultrasonography done by experts can distinguish between benign and malignant adnexal tumours with an accuracy of 95%. However, the accuracy of routine ultrasonography, which is usually done by less experienced operators, is likely to be lower. Whether improved diagnostic accuracy has a measurable effect on the management of these tumours is still unclear.
Therefore, Dr Joseph Yazbek (Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK) and colleagues did a randomised trial to assess the effect of the quality of gynaecological ultrasonography on the management of women with suspected ovarian cancer. They studied 165 patients who were referred to the regional Southeast Gynaecological Cancer Centre (London, UK) with suspected adnexal tumours between June 2004 and April 2006. Of these patients, 77 were randomly assigned to level III ultrasonography (expert)** and 73 were randomly assigned to level II ultrasonography (routine)***.
The number of major surgical staging procedures for suspected ovarian cancer was significantly higher after a routine scan (level II) than after level III (expert) ultrasonography (27 of 73 [37%] vs 17 of 77 [22%]). All women with proven ovarian cancer, however, received appropriate surgical treatment and the decrease in the number of major surgeries was limited
to women with benign ovarian disease. Crucially, a conclusive ultrasonographic diagnosis of the nature of the adnexal tumour was made in 76 of 77 (99%) patients in the level III group compared with only 38 of 73 (52%) patients in the level II group, and the authors hypothesise that this could have led to more minimally invasive procedures in the level III group (27%) than in the level II group (6%) which contributed to the significant decrease in the length of hospital stay in the level III group.
The authors conclude: "In the UK...the number of examiners who specialise in gynaecological ultrasonography is low...To achieve a high diagnostic accuracy, ultrasonography imaging needs to be combined with clinical history and physical examination. This method has been recognised by the Royal College of Obstetricians and Gynaecologists who have integrated gynaecological ultrasonography training into core and advanced specialty training in gynaecology...[but] until the number of highly trained gynaecological ultrasonographers is increased, efforts should be made to provide expert ultrasonography at least in tertiary referral units."
Notes
* Adnexal abnormalities are ovarian tumours.
** Level III examiners had more than 10 years' experience in gynaecological ultrasonography; worked in a tertiary referral unit; had been continuously involved in research in the field of in gynaecological ultrasonography; and were recognised preceptors for the training of gynaecological ultrasonography by the Royal College of Obstetrics and Gynaecologists.
*** Level II ultrasonography was done by ultrasonographers who were trained in gynaecological ultrasonography and all routinely and independently assessed patients with adnexal tumours who were referred for a second opinion from other units.
The Lancet
Ultrasonography is routinely used to assess women with various gynaecological symptoms including the detection of adnexal abnormalities*. However, the diagnostic accuracy of ultrasonography for preoperative differentiation between benign and malignant adnexal tumours is variable and depends on the experience and skill of the operator. Studies have shown that gynaecological ultrasonography done by experts can distinguish between benign and malignant adnexal tumours with an accuracy of 95%. However, the accuracy of routine ultrasonography, which is usually done by less experienced operators, is likely to be lower. Whether improved diagnostic accuracy has a measurable effect on the management of these tumours is still unclear.
Therefore, Dr Joseph Yazbek (Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK) and colleagues did a randomised trial to assess the effect of the quality of gynaecological ultrasonography on the management of women with suspected ovarian cancer. They studied 165 patients who were referred to the regional Southeast Gynaecological Cancer Centre (London, UK) with suspected adnexal tumours between June 2004 and April 2006. Of these patients, 77 were randomly assigned to level III ultrasonography (expert)** and 73 were randomly assigned to level II ultrasonography (routine)***.
The number of major surgical staging procedures for suspected ovarian cancer was significantly higher after a routine scan (level II) than after level III (expert) ultrasonography (27 of 73 [37%] vs 17 of 77 [22%]). All women with proven ovarian cancer, however, received appropriate surgical treatment and the decrease in the number of major surgeries was limited
to women with benign ovarian disease. Crucially, a conclusive ultrasonographic diagnosis of the nature of the adnexal tumour was made in 76 of 77 (99%) patients in the level III group compared with only 38 of 73 (52%) patients in the level II group, and the authors hypothesise that this could have led to more minimally invasive procedures in the level III group (27%) than in the level II group (6%) which contributed to the significant decrease in the length of hospital stay in the level III group.
The authors conclude: "In the UK...the number of examiners who specialise in gynaecological ultrasonography is low...To achieve a high diagnostic accuracy, ultrasonography imaging needs to be combined with clinical history and physical examination. This method has been recognised by the Royal College of Obstetricians and Gynaecologists who have integrated gynaecological ultrasonography training into core and advanced specialty training in gynaecology...[but] until the number of highly trained gynaecological ultrasonographers is increased, efforts should be made to provide expert ultrasonography at least in tertiary referral units."
Notes
* Adnexal abnormalities are ovarian tumours.
** Level III examiners had more than 10 years' experience in gynaecological ultrasonography; worked in a tertiary referral unit; had been continuously involved in research in the field of in gynaecological ultrasonography; and were recognised preceptors for the training of gynaecological ultrasonography by the Royal College of Obstetrics and Gynaecologists.
*** Level II ultrasonography was done by ultrasonographers who were trained in gynaecological ultrasonography and all routinely and independently assessed patients with adnexal tumours who were referred for a second opinion from other units.
The Lancet
Signs Of Heart Disease Are Attributed To Stress More Frequently In Women Than Men
Research presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), found that coronary heart disease (CHD) symptoms presented in the context of a stressful life event were identified as psychogenic in origin when presented by women and organic in origin when presented by men. The study could help explain why there is often a delay in the assessment of women with heart disease.
"We know that there is a delay in diagnosing CHD in women and this is an important step forward in understanding why," said Alexandra J. Lansky, M.D., director of the Women's Health Initiative at CRF, director of Clinical Services at the Center for Interventional Vascular Therapy, a cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, and an associate professor of clinical medicine at Columbia University College of Physicians and Surgeons.
The investigation - "Gender Bias in the Diagnosis, Treatment, and Interpretation of CHD Symptoms: Two Experimental Studies with Internists and Family Physicians," was led by Gabrielle R. Chiaramonte, Ph.D., postdoctoral associate at the Weill Medical College of Cornell University and Clinical Fellow at NewYork-Presbyterian Hospital. The study examined the effects of patients' gender and the context of how CHD symptoms are presented (with/without mention of life stressors and anxiety) on primary care physicians' patient evaluations.
"The selection of internists and family physicians was particularly relevant as they are generally the first medical professionals to assess patients' symptoms and to make treatment recommendations. A greater understanding of factors contributing to gender bias in CHD assessment in this group would thus be especially meaningful," said Dr. Chiarmonte.
The researchers hypothesized that the presence of life stressors/anxiety would shift the interpretation of women's - but not men's - CHD symptoms, so that these would be perceived to have a psychogenic etiology.
"The greater prevalence of anxiety disorders in women, along with the greater likelihood that women will discuss stressors with their physicians, and the overlap of CHD and anxiety symptoms, contribute to this shift in interpretation," Dr. Chiaramonte said.
In the studies, 87 internists (Study 1) and 143 family physicians (Study 2) read a vignette of a 47-year-old male or a 56-year-old female (by age at equal risk for CHD) presenting a multitude of CHD symptoms and risk factors. Half the vignettes included sentences indicating the patient had recently experienced a life stressor and that they appeared anxious. Each physician read one version of the vignette and then specified a diagnosis, made treatment recommendations, and indicated the etiology of symptoms.
As the investigators predicted, results showed a gender bias when CHD symptoms were presented in the context of stress, with fewer women receiving CHD diagnoses (15% versus 56%), cardiologist referrals (30% versus 62%), and prescriptions of cardiac medication (13% versus 47%) than men. No evidence of a bias was observed when CHD symptoms were presented without the stress. Results also showed that the presence of stress shifted the interpretation of women's chest pain, shortness of breath and irregular heart rate so that these were thought to have a psychogenic origin. By contrast, men's symptoms were perceived as organic whether or not stressors were present.
Dr. Chiaramonte stated, "For women, the presence of stress or anxiety drives the interpretation of accompanying symptoms so that symptoms such as chest pain or shortness of breath undergo a 'meaning shift' when presented in the context of stress or anxiety and they are perceived as a manifestation of the stress or anxiety and not as CHD symptoms. For men, cardiac symptoms drive the interpretation of accompanying symptoms so that anxiety or stress is perceived (rightly so) as a risk factor for CHD and may in fact augment the CHD assessment. The presence of anxiety or stress in men does not deter from the CHD assessment; for women, it appears to preclude a CHD assessment."
Dr. Chiaramonte warned that, "Given the overlap of CHD and anxiety symptoms (e.g., chest tightness common in both) and given the higher prevalence of anxiety symptoms or disorders in women, physicians need to be aware of gender differences in symptom presentation and they need to be especially careful to rule out CHD before considering an anxiety diagnosis. In the case of women, anxiety appears to have a pervasive influence on medical judgments regardless of the gender of the health care provider making the evaluations."
Ronald Friend, Ph.D., co-investigator, Professor of Psychology at Stony Brook University and Oregon Health & Sciences University, School of Nursing, added: "The assessment of women's CHD is further complicated by evidence that women sometimes present with 'atypical' CHD symptoms and that chest pain, a hallmark symptom in men, is less common in women. We recently conducted an additional study with 142 family physicians examining the influence of stress on the assessment of patients presenting atypical CHD symptoms. Results showed a different dynamic in this case: Women were more likely than men to receive a GI rather than a CHD diagnosis regardless of the presence of stress; the addition of stress increased GI diagnoses in both men and women. Given that women are more likely to present with atypical symptoms (and stress), these preliminary results are cause for concern."
Prior to conducting the two studies reported here, the researchers had tested their hypothesis with 99 first year medical students, 82 third and fourth year medical students, and 122 physician assistant students. The investigators were surprised to find nearly identical results whether the participants surveyed were first year medical students or experienced practicing family physicians and internists.
Dr. Chiaramonte concluded, "The consistent results observed with participants of varying clinical experience attest to the strength of the research and the pervasiveness of the effect. Our results suggest the need for the development of educational initiatives aimed at improving health care providers' understanding of gender differences in symptom presentation."
The research team included: Gabrielle R. Chiaramonte, Ph.D., of Weill Medical College of Cornell University/NewYork-Presbyterian Hospital; Ronald Friend, Ph.D., of Stony Brook University and Oregon Health & Sciences University, School of Nursing; Arnold S. Jaffe, Ph.D., and Jeffrey S. Trilling, M.D., of Stony Brook University Medical Center; Gil Weitzman, M.D., B. Robert Meyer, M.D., Susan Evans, Ph.D., and JoAnn Difede, Ph.D., of Weill Medical College of Cornell University/NewYork-Presbyterian Hospital; and Alexandra J. Lansky, M.D., of NewYork-Presbyterian Hospital/Columbia University Medical Center.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1990, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. Attended by over 10,000 participants each year, TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field of interventional cardiology and vascular medicine.
For more information, please visit crf/.
Source: Judy Romero
Cardiovascular Research Foundation
"We know that there is a delay in diagnosing CHD in women and this is an important step forward in understanding why," said Alexandra J. Lansky, M.D., director of the Women's Health Initiative at CRF, director of Clinical Services at the Center for Interventional Vascular Therapy, a cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, and an associate professor of clinical medicine at Columbia University College of Physicians and Surgeons.
The investigation - "Gender Bias in the Diagnosis, Treatment, and Interpretation of CHD Symptoms: Two Experimental Studies with Internists and Family Physicians," was led by Gabrielle R. Chiaramonte, Ph.D., postdoctoral associate at the Weill Medical College of Cornell University and Clinical Fellow at NewYork-Presbyterian Hospital. The study examined the effects of patients' gender and the context of how CHD symptoms are presented (with/without mention of life stressors and anxiety) on primary care physicians' patient evaluations.
"The selection of internists and family physicians was particularly relevant as they are generally the first medical professionals to assess patients' symptoms and to make treatment recommendations. A greater understanding of factors contributing to gender bias in CHD assessment in this group would thus be especially meaningful," said Dr. Chiarmonte.
The researchers hypothesized that the presence of life stressors/anxiety would shift the interpretation of women's - but not men's - CHD symptoms, so that these would be perceived to have a psychogenic etiology.
"The greater prevalence of anxiety disorders in women, along with the greater likelihood that women will discuss stressors with their physicians, and the overlap of CHD and anxiety symptoms, contribute to this shift in interpretation," Dr. Chiaramonte said.
In the studies, 87 internists (Study 1) and 143 family physicians (Study 2) read a vignette of a 47-year-old male or a 56-year-old female (by age at equal risk for CHD) presenting a multitude of CHD symptoms and risk factors. Half the vignettes included sentences indicating the patient had recently experienced a life stressor and that they appeared anxious. Each physician read one version of the vignette and then specified a diagnosis, made treatment recommendations, and indicated the etiology of symptoms.
As the investigators predicted, results showed a gender bias when CHD symptoms were presented in the context of stress, with fewer women receiving CHD diagnoses (15% versus 56%), cardiologist referrals (30% versus 62%), and prescriptions of cardiac medication (13% versus 47%) than men. No evidence of a bias was observed when CHD symptoms were presented without the stress. Results also showed that the presence of stress shifted the interpretation of women's chest pain, shortness of breath and irregular heart rate so that these were thought to have a psychogenic origin. By contrast, men's symptoms were perceived as organic whether or not stressors were present.
Dr. Chiaramonte stated, "For women, the presence of stress or anxiety drives the interpretation of accompanying symptoms so that symptoms such as chest pain or shortness of breath undergo a 'meaning shift' when presented in the context of stress or anxiety and they are perceived as a manifestation of the stress or anxiety and not as CHD symptoms. For men, cardiac symptoms drive the interpretation of accompanying symptoms so that anxiety or stress is perceived (rightly so) as a risk factor for CHD and may in fact augment the CHD assessment. The presence of anxiety or stress in men does not deter from the CHD assessment; for women, it appears to preclude a CHD assessment."
Dr. Chiaramonte warned that, "Given the overlap of CHD and anxiety symptoms (e.g., chest tightness common in both) and given the higher prevalence of anxiety symptoms or disorders in women, physicians need to be aware of gender differences in symptom presentation and they need to be especially careful to rule out CHD before considering an anxiety diagnosis. In the case of women, anxiety appears to have a pervasive influence on medical judgments regardless of the gender of the health care provider making the evaluations."
Ronald Friend, Ph.D., co-investigator, Professor of Psychology at Stony Brook University and Oregon Health & Sciences University, School of Nursing, added: "The assessment of women's CHD is further complicated by evidence that women sometimes present with 'atypical' CHD symptoms and that chest pain, a hallmark symptom in men, is less common in women. We recently conducted an additional study with 142 family physicians examining the influence of stress on the assessment of patients presenting atypical CHD symptoms. Results showed a different dynamic in this case: Women were more likely than men to receive a GI rather than a CHD diagnosis regardless of the presence of stress; the addition of stress increased GI diagnoses in both men and women. Given that women are more likely to present with atypical symptoms (and stress), these preliminary results are cause for concern."
Prior to conducting the two studies reported here, the researchers had tested their hypothesis with 99 first year medical students, 82 third and fourth year medical students, and 122 physician assistant students. The investigators were surprised to find nearly identical results whether the participants surveyed were first year medical students or experienced practicing family physicians and internists.
Dr. Chiaramonte concluded, "The consistent results observed with participants of varying clinical experience attest to the strength of the research and the pervasiveness of the effect. Our results suggest the need for the development of educational initiatives aimed at improving health care providers' understanding of gender differences in symptom presentation."
The research team included: Gabrielle R. Chiaramonte, Ph.D., of Weill Medical College of Cornell University/NewYork-Presbyterian Hospital; Ronald Friend, Ph.D., of Stony Brook University and Oregon Health & Sciences University, School of Nursing; Arnold S. Jaffe, Ph.D., and Jeffrey S. Trilling, M.D., of Stony Brook University Medical Center; Gil Weitzman, M.D., B. Robert Meyer, M.D., Susan Evans, Ph.D., and JoAnn Difede, Ph.D., of Weill Medical College of Cornell University/NewYork-Presbyterian Hospital; and Alexandra J. Lansky, M.D., of NewYork-Presbyterian Hospital/Columbia University Medical Center.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1990, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. Attended by over 10,000 participants each year, TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field of interventional cardiology and vascular medicine.
For more information, please visit crf/.
Source: Judy Romero
Cardiovascular Research Foundation
PEAK Surgical Announces Positive Results From Preclinical Study Of PEAK PlasmaBlade(TM) For Obstetric And Gynecologic Surgery
PEAK Surgical, Inc., a medical
device company that is developing new tissue dissection systems based on a
proprietary technology, released results from a preclinical study
demonstrating that its PEAK PlasmaBlade(TM) cut freshly excised human
abdominal tissue with little thermal tissue injury compared with
traditional electrosurgery. The PEAK PlasmaBlade is a low-temperature
tissue dissection tool that uses pulsed plasma energy to create surgical
incisions and control bleeding.
The data also showed improved surgical incision wound healing in an in
vivo porcine model compared to traditional electrosurgery. The results were
presented in a poster session at the American College of Obstetricians and
Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans by lead
investigator Dr. Paul Blumenthal, M.P.H., professor in the Department of
Obstetrics and Gynecology at Stanford University School of Medicine.
"The findings of this comparative preclinical study of tissue cutting
and healing are encouraging because they demonstrated that cuts made with
the PEAK PlasmaBlade produced minimal collateral damage compared with cuts
made with currently available electrosurgical instruments," Dr. Blumenthal
said. "This is important because collateral tissue damage may impede wound
healing, obscure histological analysis, and lead to scarring and infection
in surgical patients. New surgical cutting tools that use less heat but
offer precise soft-tissue cutting and coagulation with minimal thermal
injury could change the way we operate."
The PEAK Surgery System is not yet available in the United States. The
company has filed a 510(k) pre-market notification with the U.S. Food and
Drug Administration to market the system in the United States.
Study Design
In the study, freshly excised human abdominal tissue was cut using the
PEAK PlasmaBlade, an uncoated traditional electrosurgery scalpel, a
teflon-coated traditional electrosurgery scalpel and a fine wire and
ceramic electrosurgery scalpel. Histology samples were immediately
harvested to evaluate acute thermal tissue injury.
Also as part of the study, full-thickness skin incisions were made on
porcine skin using a traditional electrosurgery device, the PEAK
PlasmaBlade and a standard scalpel blade. Incisions were made at days 0,
21, 28, 35 and 42, and bleeding was evaluated for 60 seconds post-incision.
The wounds were then sutured to allow for healing, and digital photos of
the wounds were taken every seven days to evaluate scarring based on a
visual analog scale. Histological examination was conducted to evaluate
healing and inflammatory response.
Study Results
Histological evaluation of the ex vivo human skin showed that the PEAK
PlasmaBlade cuts produced minimal collateral damage compared to cuts made
with the other electrosurgery instruments.
In the porcine skin cuts, bleeding for 60 seconds following incision
was reduced by 60 percent in the wounds made by the PEAK PlasmaBlade
compared with those made by the standard scalpel (p=0.0001). Wound sections
showed a 75 percent reduction in acute thermal damage with the PEAK
PlasmaBlade compared with the traditional electrosurgery scalpel (p
device company that is developing new tissue dissection systems based on a
proprietary technology, released results from a preclinical study
demonstrating that its PEAK PlasmaBlade(TM) cut freshly excised human
abdominal tissue with little thermal tissue injury compared with
traditional electrosurgery. The PEAK PlasmaBlade is a low-temperature
tissue dissection tool that uses pulsed plasma energy to create surgical
incisions and control bleeding.
The data also showed improved surgical incision wound healing in an in
vivo porcine model compared to traditional electrosurgery. The results were
presented in a poster session at the American College of Obstetricians and
Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans by lead
investigator Dr. Paul Blumenthal, M.P.H., professor in the Department of
Obstetrics and Gynecology at Stanford University School of Medicine.
"The findings of this comparative preclinical study of tissue cutting
and healing are encouraging because they demonstrated that cuts made with
the PEAK PlasmaBlade produced minimal collateral damage compared with cuts
made with currently available electrosurgical instruments," Dr. Blumenthal
said. "This is important because collateral tissue damage may impede wound
healing, obscure histological analysis, and lead to scarring and infection
in surgical patients. New surgical cutting tools that use less heat but
offer precise soft-tissue cutting and coagulation with minimal thermal
injury could change the way we operate."
The PEAK Surgery System is not yet available in the United States. The
company has filed a 510(k) pre-market notification with the U.S. Food and
Drug Administration to market the system in the United States.
Study Design
In the study, freshly excised human abdominal tissue was cut using the
PEAK PlasmaBlade, an uncoated traditional electrosurgery scalpel, a
teflon-coated traditional electrosurgery scalpel and a fine wire and
ceramic electrosurgery scalpel. Histology samples were immediately
harvested to evaluate acute thermal tissue injury.
Also as part of the study, full-thickness skin incisions were made on
porcine skin using a traditional electrosurgery device, the PEAK
PlasmaBlade and a standard scalpel blade. Incisions were made at days 0,
21, 28, 35 and 42, and bleeding was evaluated for 60 seconds post-incision.
The wounds were then sutured to allow for healing, and digital photos of
the wounds were taken every seven days to evaluate scarring based on a
visual analog scale. Histological examination was conducted to evaluate
healing and inflammatory response.
Study Results
Histological evaluation of the ex vivo human skin showed that the PEAK
PlasmaBlade cuts produced minimal collateral damage compared to cuts made
with the other electrosurgery instruments.
In the porcine skin cuts, bleeding for 60 seconds following incision
was reduced by 60 percent in the wounds made by the PEAK PlasmaBlade
compared with those made by the standard scalpel (p=0.0001). Wound sections
showed a 75 percent reduction in acute thermal damage with the PEAK
PlasmaBlade compared with the traditional electrosurgery scalpel (p
Promising Outlook For National UK HPV Vaccination
This autumn, reports a recent article published on bmj,
a
??100m national UK vaccination program for the human papillomavirus
(HPV) is expected to vaccinate 70% of girls. Two types of HPV
-
both transmitted through sex and linked to cervical cancer - are
prevented by the vaccine. Vaccinations will begin in September 2008 for
all schoolgirls in the UK who are in Year 8, between 12 and 13 years
old.
Researchers from the University of Manchester conducted a pilot study
designed to investigate whether the immunization program will be a
success based on the how parents will accept the vaccine. They also
sought to analyze the feasibility of such a program to vaccinate
adolescent girls. In February 2007, two Primary Care Trusts (PCTs)
participated in the study and were charged with making sure girls in
all secondary schools in their areas received the vaccine.
There were 2,817 schoolgirls of the target age in 36 secondary
schools that were offered the HPV vaccine. Information was adequately
disseminated to parents, and they had to consent to the vaccination.
Parents were also asked to provide reasons if they refused the
vaccination for their daughter.
Although three doses are required at 0, 1, and 6 months in order
for the vaccine to be fully effective, the researchers were able to
report the number and percentage of girls who received the first dose
(1,989 or 70.6%) and the second dose (1,930 or 68.5%). Delivery of the
vaccinations proved challenging for many reasons. Schools were very
busy at the beginning of the academic year when the first doses needed
to be administered, and 16.3% of girls missed the appointment time for
the first dose and 23.6% missed the second dose.
Of parents who refused to allow the vaccination, 36% claimed that they
did not have sufficient information about the long term safety of the
vaccine, 10% were concerned about the age of the girls, and 3% were
concerned that the vaccination would influence adolescent sexual
behavior.
"These are encouraging results for the
forthcoming national HPV vaccine programme but the final criterion for
success will be the proportion of girls who receive all three vaccine
doses," conclude the researchers.
An accompanying editorial, Jo Waller and Jane Wardle (Cancer
Research UK), suggest that, "In the wake of the controversy about the
measles, mumps, and rubella (MMR)
vaccine, work needs to be done to restore public confidence in
immunisation." Since 20% of parents in the study refused
the vaccine without reason, "More
work is therefore needed to understand the motives for refusal and the
practical barriers to providing consent."
Uptake of first two doses of human papillomavirus vaccine by
adolescent schoolgirls in Manchester: prospective cohort study
Loretta Brabin, Stephen A Roberts, Rebecca Stretch, David Baxter,
Gloria Chambers, Henry Kitchener, Rosemary McCann
BMJ. (April 2008)
doi:10.1136/bmj.39541.534109.BE
Click
Here to See Article Online
: Peter M Crosta
a
??100m national UK vaccination program for the human papillomavirus
(HPV) is expected to vaccinate 70% of girls. Two types of HPV
-
both transmitted through sex and linked to cervical cancer - are
prevented by the vaccine. Vaccinations will begin in September 2008 for
all schoolgirls in the UK who are in Year 8, between 12 and 13 years
old.
Researchers from the University of Manchester conducted a pilot study
designed to investigate whether the immunization program will be a
success based on the how parents will accept the vaccine. They also
sought to analyze the feasibility of such a program to vaccinate
adolescent girls. In February 2007, two Primary Care Trusts (PCTs)
participated in the study and were charged with making sure girls in
all secondary schools in their areas received the vaccine.
There were 2,817 schoolgirls of the target age in 36 secondary
schools that were offered the HPV vaccine. Information was adequately
disseminated to parents, and they had to consent to the vaccination.
Parents were also asked to provide reasons if they refused the
vaccination for their daughter.
Although three doses are required at 0, 1, and 6 months in order
for the vaccine to be fully effective, the researchers were able to
report the number and percentage of girls who received the first dose
(1,989 or 70.6%) and the second dose (1,930 or 68.5%). Delivery of the
vaccinations proved challenging for many reasons. Schools were very
busy at the beginning of the academic year when the first doses needed
to be administered, and 16.3% of girls missed the appointment time for
the first dose and 23.6% missed the second dose.
Of parents who refused to allow the vaccination, 36% claimed that they
did not have sufficient information about the long term safety of the
vaccine, 10% were concerned about the age of the girls, and 3% were
concerned that the vaccination would influence adolescent sexual
behavior.
"These are encouraging results for the
forthcoming national HPV vaccine programme but the final criterion for
success will be the proportion of girls who receive all three vaccine
doses," conclude the researchers.
An accompanying editorial, Jo Waller and Jane Wardle (Cancer
Research UK), suggest that, "In the wake of the controversy about the
measles, mumps, and rubella (MMR)
vaccine, work needs to be done to restore public confidence in
immunisation." Since 20% of parents in the study refused
the vaccine without reason, "More
work is therefore needed to understand the motives for refusal and the
practical barriers to providing consent."
Uptake of first two doses of human papillomavirus vaccine by
adolescent schoolgirls in Manchester: prospective cohort study
Loretta Brabin, Stephen A Roberts, Rebecca Stretch, David Baxter,
Gloria Chambers, Henry Kitchener, Rosemary McCann
BMJ. (April 2008)
doi:10.1136/bmj.39541.534109.BE
Click
Here to See Article Online
: Peter M Crosta
Phase 2 Clinical Trial Evaluates Bremelanotide In Pre- And Post-Menopausal Female Sexual Dysfunction Patients
Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc.
(NYSE: KG) announced today that the companies have completed enrollment in
the pre-menopausal cohort of a Phase 2 "at-home" clinical trial evaluating
bremelanotide in pre- and post-menopausal patients experiencing female
sexual dysfunction (FSD). The FSD clinical trial is designed to evaluate
the initial multiple-dose safety and efficacy of bremelanotide in both pre-
and post- menopausal women, and will provide the companies with information
that will guide selection of clinical endpoints and estimates of treatment
effect size for future clinical trials. The results from this trial are
anticipated to be released in calendar year 2007. Bremelanotide is a drug
candidate for the treatment of male and female sexual dysfunction and is
being developed for regulatory approval and commercialization by Palatin
and King Pharmaceuticals.
"Based on positive results from a pilot safety/clinical pharmacology
study evaluating bremelanotide in FSD patients, Palatin and King
Pharmaceuticals are jointly committed to advancing the clinical development
of bremelanotide for FSD and are pleased to report continued progress in
the execution of our development program," said Trevor Hallam, Ph.D.,
Palatin's Executive Vice President of Research & Development. "Both female
sexual dysfunction and male sexual dysfunction represent significant market
opportunities where we believe bremelanotide has the potential to address
unmet medical needs."
About Female Sexual Dysfunction (FSD)
FSD consists of four components, hypoactive sexual desire disorder,
female sexual arousal disorder, dyspareunia or painful intercourse and
anorgasmia. To establish a diagnosis of FSD, these components must be
associated with personal distress, as determined by the affected woman. A
February 10, 1999 study published in the Journal of the American Medical
Association, JAMA, titled, "Sexual Dysfunction in the United States:
Prevalence and Predictors," states that some form of FSD appears to be
prevalent in approximately 43 percent of the female population.
About Bremelanotide (formerly PT-141)
Bremelanotide is the first compound in a new drug class called
melanocortin receptor agonists under development to treat sexual
dysfunction. This new chemical entity is being evaluated in Phase 2
clinical trials studying the efficacy and safety profile of varying doses
of this novel compound in men experiencing erectile dysfunction (ED) and
women experiencing female sexual dysfunction (FSD). The mechanism of action
of bremelanotide may offer important benefits over currently available
products for the treatment of ED because it acts on the pathway that
controls sexual function without acting directly on the vascular system.
Clinical data indicates that bremelanotide may be effective in treating a
broad range of patients suffering from ED.
Although the current ED market is primarily served by PDE-5 inhibitors
which target the vascular system, a substantial unmet medical need for
alternative sexual dysfunction therapies exists. Many patients are
contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition,
current literature indicates that about one half of all patients who
receive an initial prescription for a PDE-5 inhibitor do not renew the
prescription due chiefly to adverse side effects, drug interaction issues,
and/or the lack of an acceptable level of responsiveness.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. It is estimated that some degree
of ED affects one half of all men over the age of 40 and that 150 million
men worldwide suffer from ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company primarily
engaged in the development of melanocortin-based therapeutics. The Company
has a pipeline of product candidates in development. The Company's internal
research and development capabilities, anchored by its proprietary
MIDAS(TM) technology, are fueling product development. Palatin's strategy
is to develop products and then form marketing collaborations with industry
leaders in order to maximize their commercial potential. To date, the
Company has formed partnerships with Tyco Healthcare Mallinckrodt and King
Pharmaceuticals. For additional information regarding Palatin, please visit
Palatin Technologies' website at palatin.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle management.
Forward-looking Statements
This release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements reflect
managements' current views of future events and operations, including, but
not limited to, statements pertaining to the anticipated data of release of
the clinical trial results; proposed indications for bremelanotide; the
significance of the results from the clinical trials of bremelanotide; and
the conduct of future clinical trials. Some important factors which may
cause results to differ materially from such forward-looking statements
include dependence on the actual results of the companies' bremelanotide
development activities; dependence on the companies' abilities to fund
development of bremelanotide; dependence on the companies' abilities to
complete clinical trials as anticipated; dependence on the availability and
cost of raw materials; dependence on the unpredictability of the duration
and results of the U.S. Food and Drug Administration's ("FDA") review of
Investigational New Drug Applications ("IND"), New Drug Applications
("NDA"), and supplemental New Drug Applications ("sNDAs"), and/or the
review of other regulatory agencies worldwide; dependence on compliance
with FDA and other government regulations that relate to King's and
Palatin's respective businesses; dependence on King's and Palatin's
abilities to successfully manufacture bremelanotide; and dependence on
changes in general economic and business conditions; changes in current
pricing levels; changes in federal and state laws and regulations; changes
in competition; unexpected changes in technologies and technological
advances; and manufacturing capacity constraints. Other important factors
that may cause actual results to differ materially from the forward-looking
statements are discussed in the "Risk Factors" section and other sections
of King's Form 10-K for the year ended December 31, 2005 and Form 10-Q for
the quarter ended September 30, 2006, and Palatin's Form 10-K for the year
ended June 30, 2006, which are on file with the U.S. Securities and
Exchange Commission. The companies do not undertake to publicly update or
revise any of their forward-looking statements even if experience or future
changes show that the indicated results or events will not be realized.
King Pharmaceuticals, Inc.
palatin
(NYSE: KG) announced today that the companies have completed enrollment in
the pre-menopausal cohort of a Phase 2 "at-home" clinical trial evaluating
bremelanotide in pre- and post-menopausal patients experiencing female
sexual dysfunction (FSD). The FSD clinical trial is designed to evaluate
the initial multiple-dose safety and efficacy of bremelanotide in both pre-
and post- menopausal women, and will provide the companies with information
that will guide selection of clinical endpoints and estimates of treatment
effect size for future clinical trials. The results from this trial are
anticipated to be released in calendar year 2007. Bremelanotide is a drug
candidate for the treatment of male and female sexual dysfunction and is
being developed for regulatory approval and commercialization by Palatin
and King Pharmaceuticals.
"Based on positive results from a pilot safety/clinical pharmacology
study evaluating bremelanotide in FSD patients, Palatin and King
Pharmaceuticals are jointly committed to advancing the clinical development
of bremelanotide for FSD and are pleased to report continued progress in
the execution of our development program," said Trevor Hallam, Ph.D.,
Palatin's Executive Vice President of Research & Development. "Both female
sexual dysfunction and male sexual dysfunction represent significant market
opportunities where we believe bremelanotide has the potential to address
unmet medical needs."
About Female Sexual Dysfunction (FSD)
FSD consists of four components, hypoactive sexual desire disorder,
female sexual arousal disorder, dyspareunia or painful intercourse and
anorgasmia. To establish a diagnosis of FSD, these components must be
associated with personal distress, as determined by the affected woman. A
February 10, 1999 study published in the Journal of the American Medical
Association, JAMA, titled, "Sexual Dysfunction in the United States:
Prevalence and Predictors," states that some form of FSD appears to be
prevalent in approximately 43 percent of the female population.
About Bremelanotide (formerly PT-141)
Bremelanotide is the first compound in a new drug class called
melanocortin receptor agonists under development to treat sexual
dysfunction. This new chemical entity is being evaluated in Phase 2
clinical trials studying the efficacy and safety profile of varying doses
of this novel compound in men experiencing erectile dysfunction (ED) and
women experiencing female sexual dysfunction (FSD). The mechanism of action
of bremelanotide may offer important benefits over currently available
products for the treatment of ED because it acts on the pathway that
controls sexual function without acting directly on the vascular system.
Clinical data indicates that bremelanotide may be effective in treating a
broad range of patients suffering from ED.
Although the current ED market is primarily served by PDE-5 inhibitors
which target the vascular system, a substantial unmet medical need for
alternative sexual dysfunction therapies exists. Many patients are
contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition,
current literature indicates that about one half of all patients who
receive an initial prescription for a PDE-5 inhibitor do not renew the
prescription due chiefly to adverse side effects, drug interaction issues,
and/or the lack of an acceptable level of responsiveness.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. It is estimated that some degree
of ED affects one half of all men over the age of 40 and that 150 million
men worldwide suffer from ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company primarily
engaged in the development of melanocortin-based therapeutics. The Company
has a pipeline of product candidates in development. The Company's internal
research and development capabilities, anchored by its proprietary
MIDAS(TM) technology, are fueling product development. Palatin's strategy
is to develop products and then form marketing collaborations with industry
leaders in order to maximize their commercial potential. To date, the
Company has formed partnerships with Tyco Healthcare Mallinckrodt and King
Pharmaceuticals. For additional information regarding Palatin, please visit
Palatin Technologies' website at palatin.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle management.
Forward-looking Statements
This release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements reflect
managements' current views of future events and operations, including, but
not limited to, statements pertaining to the anticipated data of release of
the clinical trial results; proposed indications for bremelanotide; the
significance of the results from the clinical trials of bremelanotide; and
the conduct of future clinical trials. Some important factors which may
cause results to differ materially from such forward-looking statements
include dependence on the actual results of the companies' bremelanotide
development activities; dependence on the companies' abilities to fund
development of bremelanotide; dependence on the companies' abilities to
complete clinical trials as anticipated; dependence on the availability and
cost of raw materials; dependence on the unpredictability of the duration
and results of the U.S. Food and Drug Administration's ("FDA") review of
Investigational New Drug Applications ("IND"), New Drug Applications
("NDA"), and supplemental New Drug Applications ("sNDAs"), and/or the
review of other regulatory agencies worldwide; dependence on compliance
with FDA and other government regulations that relate to King's and
Palatin's respective businesses; dependence on King's and Palatin's
abilities to successfully manufacture bremelanotide; and dependence on
changes in general economic and business conditions; changes in current
pricing levels; changes in federal and state laws and regulations; changes
in competition; unexpected changes in technologies and technological
advances; and manufacturing capacity constraints. Other important factors
that may cause actual results to differ materially from the forward-looking
statements are discussed in the "Risk Factors" section and other sections
of King's Form 10-K for the year ended December 31, 2005 and Form 10-Q for
the quarter ended September 30, 2006, and Palatin's Form 10-K for the year
ended June 30, 2006, which are on file with the U.S. Securities and
Exchange Commission. The companies do not undertake to publicly update or
revise any of their forward-looking statements even if experience or future
changes show that the indicated results or events will not be realized.
King Pharmaceuticals, Inc.
palatin
FDA Advisory Panel Unanimously Endorses Five-Day Emergency Contraceptive
On Thursday, FDA's Reproductive Health Drugs Advisory Committee voted unanimously to recommend that the agency approve the emergency contraceptive ulipristal acetate, or UPA, because evidence shows it is safe and effective for preventing most pregnancies for up to 120 hours after sex, NPR's "Morning Edition" reports. FDA usually follows the recommendations of its advisory panels, but it is not required to do so (Rovner, "Morning Edition," NPR, 6/18).
View drug information on ella.
UPA is manufactured by Paris-based HRA Pharma and sold in 22 European countries as ellaOne. Pending FDA approval, UPA will be marketed in the U.S. under the brand name "ella" by Watson Pharmaceuticals (Rubin, USA Today, 6/18).
FDA's decision on whether to approve ella is expected by late July or early August, according to Charlie Mayr, a spokesperson for Watson.
If approved, ella would be available by prescription only. Mayr said he is unable to say how much ella would cost because ella has not yet received FDA approval (USA Today, 6/18).
According to the New York Times, studies have found ella to be more effective over a longer period of time than Plan B, an emergency contraceptive product currently available in the U.S. Because ella is a chemical relative to the medical abortion drug known as RU-486, antiabortion-rights groups took issue with claims that the drugmaker was seeking approval of the drug as a contraceptive (Harris, New York Times, 6/18). Several medical experts speaking at the hearing said that there is no scientific evidence that the recommended dose of ella acts as an abortifacient, as some antiabortion-rights groups contend ("Morning Edition," NPR, 6/18).
'Nightly News' Examines Hearing
On Thursday, NBC chief medical editor Nancy Snyderman discussed the next steps in the approval process on NBC's "Nightly News" (Holt, "Nightly News," NBC, 6/17).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
View drug information on ella.
Cultural Traditions Hindering Use Of Female Condoms, HIV/AIDS Conference Delegates Say
Cultural traditions are among the main reasons for the low rate of female condom use, delegates attending the 2007 HIV/AIDS Implementers' Meeting in Kigali, Rwanda, said recently, the New Times/AllAfrica reports (Musoni, New Times/AllAfrica, 6/18).
More than 2,000 delegates attended the four-day conference, which was hosted by the Rwandan government and organized by the President's Emergency Plan for AIDS Relief and the Global Fund To Fight AIDS, Tuberculosis and Malaria. Other organizers include UNAIDS, the World Bank, UNICEF and the World Health Organization (Kaiser Daily HIV/AIDS Report, 6/19).
Conference participants discussed the future direction of HIV/AIDS programs and emphasized identifying and implementing partnerships among governments, businesses, the health care sector and others to fight the spread of HIV, VOA News reports (Majtenyi, VOA News, 6/18).
Sarah Kambou, vice president of health and development at the International Center for Research on Women, on Sunday at the conference said that culture is one of the factors that has contributed to the low rate of female condom use. Kambou said that "women don't know how they introduce" female condoms to their husbands, adding that a lot of advocacy is needed to "overcome this challenge." David Wilson, a member of the World Bank's Global AIDS Monitoring and Evaluation Team, said that the reason why female condoms are not popular is because women often lack empowerment in society.
David Apuuli, director-general of the Uganda AIDS Commission, said that it is difficult in African societies for women to promote condom use to their husbands. He added that another potential reason is that in "some cases, women who use [condoms] have complained that they are not user friendly" and that "they make a lot of noise during sexual intercourse." Apuuli also said that some condoms have been rejected because of their bad smell (New Times/AllAfrica, 6/18).
"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.
More than 2,000 delegates attended the four-day conference, which was hosted by the Rwandan government and organized by the President's Emergency Plan for AIDS Relief and the Global Fund To Fight AIDS, Tuberculosis and Malaria. Other organizers include UNAIDS, the World Bank, UNICEF and the World Health Organization (Kaiser Daily HIV/AIDS Report, 6/19).
Conference participants discussed the future direction of HIV/AIDS programs and emphasized identifying and implementing partnerships among governments, businesses, the health care sector and others to fight the spread of HIV, VOA News reports (Majtenyi, VOA News, 6/18).
Sarah Kambou, vice president of health and development at the International Center for Research on Women, on Sunday at the conference said that culture is one of the factors that has contributed to the low rate of female condom use. Kambou said that "women don't know how they introduce" female condoms to their husbands, adding that a lot of advocacy is needed to "overcome this challenge." David Wilson, a member of the World Bank's Global AIDS Monitoring and Evaluation Team, said that the reason why female condoms are not popular is because women often lack empowerment in society.
David Apuuli, director-general of the Uganda AIDS Commission, said that it is difficult in African societies for women to promote condom use to their husbands. He added that another potential reason is that in "some cases, women who use [condoms] have complained that they are not user friendly" and that "they make a lot of noise during sexual intercourse." Apuuli also said that some condoms have been rejected because of their bad smell (New Times/AllAfrica, 6/18).
"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.
U.S. Should Use Position On U.N. Human Rights Council To End Sex-Selective Abortion In India, Opinion Piece Says
The United States' new membership in the United Nations Human Rights Council came "not a moment too soon for girls in India," where rates of infanticide and sex-selective abortion are "worsening in most areas," according to a Christian Science Monitor opinion piece by Madeline Wheeler, a writer and child abuse prevention advocate. Although a report issued this week indicates that the number of women seeking abortions worldwide has decreased over the last 10 years, "[t]his is not the case in India, where the demographic imbalance of gender ... has reached epic proportions -- due in large part to abortions," Wheeler writes.
According to UNICEF figures, there has been a worldwide decline in mortality among children younger than age five over the last decade. However, the decline is "insufficient to reach the U.N. goal of a two-thirds reduction by 2015," Wheeler writes, adding that the current goals "don't specifically address infanticide in India." According to Wheeler, about 21% of the world's under-five mortality rate occurs in India, "and that doesn't include infanticide" in the country. She notes that there are an estimated 105 female births for every 100 males in most countries, but there are fewer than 93 women for every 100 men in India. Sex-selective abortion is more common among higher-income families in urban areas, such as New Delhi, Haryana and Punjab, Wheeler writes. According to India's 2001 national census, there were only 798 girls per 1,000 boys in some parts of Punjab, while a recent study by ActionAid found that the gender disparity has risen to 300 girls per 1,000 boys, Wheeler reports.
Wheeler continues that India banned sex-selective abortion, as well as amniocentesis and sonography for sex determination, more than 10 years ago, yet the "death toll of female fetuses continues to rise" and the "illegal sex-selective abortion industry makes about $250 million a year in India." The main reason for sex-selective abortion is partly because of "deeply rooted gender norms in India [that] devalue women" and position men as the primary source of income and land rights. "The burden of females, however, requires expensive piercing rituals, a large dowry, and wedding expenses," and for those who "only have daughters, it's believed you will be reincarnated in a lower caste," she writes.
The Indian government has created initiatives to curb the practice, but "it hasn't been enough," and pressure from the international community "is also needed," Wheeler writes. The Convention on the Rights of the Child -- which "upholds a universally agreed-upon set of nonnegotiable basic human rights standards and obligations, including the right to survival and protection" -- will reach its 20th anniversary in October, Wheeler notes. "If the convention recommitted to protecting girls and ending 'son preference', this would send a strident message to the people of India," she says. "The future of India depends on turning this around now, and the U.S. has the power to influence this change," Wheeler writes, concluding, "As a new Human Rights Council member, the U.S. should leap to the forefront of this cause and ratify the Convention on the Rights of the Child" (Wheeler, Christian Science Monitor, 10/14).
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.
What Is Vulvodynia? What Causes Vulvodynia?
Vulvodynia, also known as vestibulodynia, is a condition from which 15% of women suffer. Usually found in women who are younger to middle-aged, the condition is not infective and can be suppressed with proper treatment.
Vulvodynia is a chronic discomfort inside the vulva, the entrance to the vagina and to the urethra. It occurs as a result of problems with the nerve fibers in that area, and it does not manifest itself visually. It is characterized by the nerve endings in those areas being super-sensitive and painful to the touch. The pain may be constant or come and go in cycles.
The pain is usually described as a burning, stinging, itching, irritating or a raw feeling. Sexual intercourse, walking, sitting or exercising can make the pain worse.
According to Medilexicon's medical dictionary:
Vulvodynia is chronic vulvar discomfort with complaints of burning and superficial irritation.
It can be present in the labia majora and/or labia minora. Sometimes it affects the clitoris, perineum, mons pubis and/or inner thighs. The pain may be constant or intermittent, and it is not necessarily initiated by touch or pressure to the vulva. The vulvar tissue may appear inflamed, but in most cases there are no visible findings.
Vulvodynia usually starts suddenly and may last for months to years. Although it isn't life-threatening, the pain may make one cut back on some normal activities. It can also make one upset or depressed. It might even cause problems in one's relationship with spouse or partner, because it can make sexual intercourse painful.
What are the symptoms of Vulvodynia?
A symptom is something the patient senses and describes, while a sign is something other people, such as the doctor notice. For example, drowsiness may be a symptom while dilated pupils may be a sign.
Pain is the most notable symptom of vulvodynia, and can be characterized as a burning, stinging, irritation or sharp pain that occurs in the vulva, including the labia and entrance to the vagina. It may be constant, intermittent or happening only when the vulva is touched, but vulvodynia is usually defined as lasting for at least three months.
The pain is usually found around the urethra and at the top of the legs and inner thighs, and it can be either intermittent or constant.
Symptoms may occur in one place or the entire vulvar area. It can occur during or after sexual activity, when tampons are inserted, or when prolonged pressure is applied to the vulva, such as during sitting, bike riding, or horseback riding.
What are the causes of Vulvodynia?
The exact cause of vulvodynia isn't known.
Some factors that may be involved include frequent yeast infections or sexually transmitted infections, chemical irritation of the external genitals (from soaps, feminine hygiene products or detergents in clothing), rashes on the genital area, previous laser treatments or surgery on the external genitals, nerve irritation, injury or muscle spasms in the pelvic area, diabetes and precancerous or cancerous conditions on the cervix.
Vulvodynia can be confused with other vulvo-vaginal problems such as chronic tension or spasm of the muscles of the vulvar area called vaginismus. This is particularly difficult to distinguish as muscular spasms can cause pain and pain can cause muscular spasms.
Diagnosing Vulvodynia
One may need to have a pelvic exam and tests to check for bacteria and yeast. If any test results don't seem normal, a doctor may want you to have a colposcopy or a biopsy. Colposcopy is an exam of the genital area that uses a special magnifying glass. If one has a biopsy, the genital area is first numbed with a painkiller, and a small piece of tissue is taken to be looked at with a microscope.
A cotton swab test is used to delineate the areas of pain and categorize their severity. Patients often will describe the touch of a cotton ball as extremely painful, like the scraping of a knife.
What are the treatment options for Vulvodynia?
Any treatment of vulvodynia takes many days or months to reach full effectiveness, and there is never a guarantee of a complete loss of the symptoms.
However, the drug amitriptyline, an antidepressant, has proven the most effective solution in lessening the effects of vulvodynia.
In addition, other antidepressants and anticonvulsants can be used to good effect. The use of certain creams and lotions, as well as anaesthetic gel in the vulval area can help treat the symptoms as well. Specific exercises and biofeedback may prove useful. Finally, since stress is one of the suspected causes of vulvodynia, management of stress may very well help ease symptoms.
Preventing Vulvodynia
Several options exist to prevent vulvodynia from occurring. First, wearing cotton underwear and loose-fitting clothes in that area can help to prevent vulvodynia, as can avoiding scented toilet paper and perfumed creams and soaps. In general, avoiding friction to that area is a good preventative measure, as is avoiding sitting for prolonged periods.
Women should avoid excessive genital washing and douching. If a vaginal infection is suspected, it is important to have it diagnosed and treated promptly, and to let a physician know if any treatments are making the condition worse.
Sy Kraft (B.A.)
Vulvodynia is a chronic discomfort inside the vulva, the entrance to the vagina and to the urethra. It occurs as a result of problems with the nerve fibers in that area, and it does not manifest itself visually. It is characterized by the nerve endings in those areas being super-sensitive and painful to the touch. The pain may be constant or come and go in cycles.
The pain is usually described as a burning, stinging, itching, irritating or a raw feeling. Sexual intercourse, walking, sitting or exercising can make the pain worse.
According to Medilexicon's medical dictionary:
Vulvodynia is chronic vulvar discomfort with complaints of burning and superficial irritation.
It can be present in the labia majora and/or labia minora. Sometimes it affects the clitoris, perineum, mons pubis and/or inner thighs. The pain may be constant or intermittent, and it is not necessarily initiated by touch or pressure to the vulva. The vulvar tissue may appear inflamed, but in most cases there are no visible findings.
Vulvodynia usually starts suddenly and may last for months to years. Although it isn't life-threatening, the pain may make one cut back on some normal activities. It can also make one upset or depressed. It might even cause problems in one's relationship with spouse or partner, because it can make sexual intercourse painful.
What are the symptoms of Vulvodynia?
A symptom is something the patient senses and describes, while a sign is something other people, such as the doctor notice. For example, drowsiness may be a symptom while dilated pupils may be a sign.
Pain is the most notable symptom of vulvodynia, and can be characterized as a burning, stinging, irritation or sharp pain that occurs in the vulva, including the labia and entrance to the vagina. It may be constant, intermittent or happening only when the vulva is touched, but vulvodynia is usually defined as lasting for at least three months.
The pain is usually found around the urethra and at the top of the legs and inner thighs, and it can be either intermittent or constant.
Symptoms may occur in one place or the entire vulvar area. It can occur during or after sexual activity, when tampons are inserted, or when prolonged pressure is applied to the vulva, such as during sitting, bike riding, or horseback riding.
What are the causes of Vulvodynia?
The exact cause of vulvodynia isn't known.
Some factors that may be involved include frequent yeast infections or sexually transmitted infections, chemical irritation of the external genitals (from soaps, feminine hygiene products or detergents in clothing), rashes on the genital area, previous laser treatments or surgery on the external genitals, nerve irritation, injury or muscle spasms in the pelvic area, diabetes and precancerous or cancerous conditions on the cervix.
Vulvodynia can be confused with other vulvo-vaginal problems such as chronic tension or spasm of the muscles of the vulvar area called vaginismus. This is particularly difficult to distinguish as muscular spasms can cause pain and pain can cause muscular spasms.
Diagnosing Vulvodynia
One may need to have a pelvic exam and tests to check for bacteria and yeast. If any test results don't seem normal, a doctor may want you to have a colposcopy or a biopsy. Colposcopy is an exam of the genital area that uses a special magnifying glass. If one has a biopsy, the genital area is first numbed with a painkiller, and a small piece of tissue is taken to be looked at with a microscope.
A cotton swab test is used to delineate the areas of pain and categorize their severity. Patients often will describe the touch of a cotton ball as extremely painful, like the scraping of a knife.
What are the treatment options for Vulvodynia?
Any treatment of vulvodynia takes many days or months to reach full effectiveness, and there is never a guarantee of a complete loss of the symptoms.
However, the drug amitriptyline, an antidepressant, has proven the most effective solution in lessening the effects of vulvodynia.
In addition, other antidepressants and anticonvulsants can be used to good effect. The use of certain creams and lotions, as well as anaesthetic gel in the vulval area can help treat the symptoms as well. Specific exercises and biofeedback may prove useful. Finally, since stress is one of the suspected causes of vulvodynia, management of stress may very well help ease symptoms.
Preventing Vulvodynia
Several options exist to prevent vulvodynia from occurring. First, wearing cotton underwear and loose-fitting clothes in that area can help to prevent vulvodynia, as can avoiding scented toilet paper and perfumed creams and soaps. In general, avoiding friction to that area is a good preventative measure, as is avoiding sitting for prolonged periods.
Women should avoid excessive genital washing and douching. If a vaginal infection is suspected, it is important to have it diagnosed and treated promptly, and to let a physician know if any treatments are making the condition worse.
Sy Kraft (B.A.)
Health Reform Law Prohibits Gender Rating, Offers Other Benefits For Women's Health
Under the recently signed health reform law (HR 3590), health insurance companies will no longer be able to charge women more than men for the same insurance policies, ending a practice known as "gender rating," the New York Times reports. In the past, insurance companies "took full advantage" of the lack of restrictions on gender rating in the individual insurance market, arguing that women should pay more for health coverage because they tend to use the health system more than men, the Times reports.
According to a 2008 report from the National Women's Law Center, some companies charged women 4% to 48% in higher premiums than men in the individual market, even for insurance policies that did not include maternity coverage. Now, gender rating is "essentially outlawed" and maternity coverage is considered an "essential health benefit," the Times reports.
According to the Times, although gender rating "has been perfectly legal" in the individual insurance market, some insurers also have applied the practice to small-group coverage, but laws against sex discrimination in the workplace prohibit employers from passing on higher costs to their employees. As a result, some midsize and small businesses -- which tend to have more female employees -- have been forced to offer plans with very high deductibles or drop health benefits altogether, the Times reports.
Marcia Greenberger, founder and co-president of NWLC, said the health care and insurance industries "in general [have] been riddled with the most discriminatory and unfair practices to women." She added that the health reform law "is a giant leap forward to dismantling the unfairness that has been a part of the system."
Greenberger said that although some of the law's provisions will be delayed until 2014, the ban on gender rating will take effect immediately. She added that no organization that receives federal funding will be able to discriminate on the basis of sex, including insurers, making gender rating "a problem whose days are numbered."
The new law also prohibits denying coverage based on pre-existing conditions, including for women who have had caesarean sections or experienced domestic violence. In a statement issued Thursday, Sen. Barbara Mikulski (D-Md.) drew attention to a woman who testified before Congress that she was denied coverage after a medically necessary c-section. Mikulski said, "That will never, ever happen again because of what we did here with health care reform" (Grady, New York Times, 3/29).
According to HealthLeaders Media, the new law will expand private insurance and Medicaid coverage to millions of uninsured, low-income women. About 45% of women are uninsured or underinsured, compared with 39% of men, according to NWLC. Kirsten Sloan, vice president of the National Partnership for Women & Families, said that a significant portion of the 31 million U.S. residents who gain health insurance under the law will be women. She added, "That is top of the list for everybody, but looking down from there, you've got benefit issues ... that are of particular interest to women now being covered." For example, private health plans and Medicare will be required to cover the cost of preventive services, such as mammograms, Pap tests and immunizations (Simmons, HealthLeaders Media, 3/29).
According to the Times, the new law also will allocate $1.5 billion over five years for nurse home-visit programs for pregnant teenagers. Such programs have been shown to help teen mothers learn parenting and coping skills that help reduce child abuse and neglect by nearly 50%, according to research published in the Journal of the American Medical Association. The law also mandates that employers allow women who are breastfeeding periodic breaks to pump breastmilk and that they provide a private place that is not a bathroom to do so.
The law also allocates $50 million per year over five years in matching federal funds for states to use for abstinence-only sex education programs. President Obama cut $115 million in funding for such programs in his fiscal year 2010 budget, instead appropriating funds for comprehensive approaches to reducing teen pregnancy. In June 2009, Congress allowed an additional $50 million in abstinence-only funding to expire. However, states are required to match any federal funding they receive. Heather Boonstra, senior public policy associate at the Guttmacher Institute, said this provision "may be significant" because "many states had already stopped participating" in abstinence-only programs (Andrews, New York Times, 3/30).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
Revisions To Rhode Island Abstinence Curriculum Approved For Use In High Schools, State Education Commissioner Says
Revised lesson plans from a federally funded abstinence-only-until-marriage sex education curriculum developed by Heritage of Rhode Island meet state standards and can be taught in high schools, Rhode Island Education Commissioner Peter McWalters wrote in a memo to school superintendents last month, the Providence Journal reports (Castellucci, Providence Journal, 12/4). The Rhode Island Affiliate of the American Civil Liberties Union on Sept. 21, 2005, sent a letter to McWalters saying the curriculum developed by Heritage of Rhode Island would violate relevant state law. McWalters in March sent an advisory to all superintendents in the state saying Heritage's program is not "consistent with Rhode Island Health Education Standards" and should not be taught in state schools. Heritage -- which has presented its program to more than 600 public schools in the state -- has a three-year grant from HHS that provides $400,200 annually, according to an HHS spokesperson (Kaiser Daily Women's Health Policy Report, 3/24). Heritage said the program is intended to supplement, not replace, current HIV/AIDS instruction in the public school system, and Heritage instructors will provide abstinence-only sex education only in the presence of regular classroom teachers who are responsible for teaching the general curriculum required. Heritage Executive Director Chris Plante on Sunday said he was pleased with the way the state's review process worked and is speaking to local officials about incorporating the program in high schools in Warwick, R.I., and Woonsocket, R.I., adding that very little was changed with the program. ACLU Rhode Island Executive Director Steven Brown said the revised program still emphasizes marriage as the only safe setting for sex, which tends to marginalize gay and lesbian students and students with gay or lesbian parents. The program also understates the effectiveness of condoms as a means of protection against sexually transmitted infections and a form of contraception, Brown said. ACLU, in response to the approval, is drafting a letter to McWalters expressing concern about the program, Brown said (Providence Journal, 12/4).
"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.
"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.
Kansas AG Morrison Voices Concerns About Security Of Medical Records Of Women Who Underwent Late-Term Abortions
Kansas Attorney General Paul Morrison (D) after being sworn in to the office on Monday said he is concerned the medical records of 90 women and girls who in 2003 underwent late-term abortions subpoenaed by former Attorney General Phill Kline (R) might have been copied, the AP/Wichita Eagle reports (Hanna, AP/Wichita Eagle, 1/8). Kline in 2004 subpoenaed the records of the women and girls who received late-term abortions at Comprehensive Health, which is operated by Planned Parenthood of Kansas and Mid-Missouri in Overland Park, Kan., and Women's Health Care Services in Wichita, Kan., saying there is probable cause that each record contains evidence of a felony. The state Supreme Court in February 2006 ruled that Kline can seek access to the records but that he must return to Shawnee County, Kan., District Court Judge Richard Anderson and present his reasons for seeking the subpoenas. Anderson turned over the records to Kline's office in November 2006 after removing information that would identify individuals (Kaiser Daily Women's Health Policy Report, 12/4/06). Kline last month filed 30 misdemeanor charges against Women's Health Care Services owner George Tiller for allegedly performing 15 illegal late-term abortions in 2003 on patients ages 10 to 22 without properly reporting the details to the state. Kline hired attorney Don McKinney to be special prosecutor in the case (Kaiser Daily Women's Health Policy Report, 1/2). A Sedgwick County, Kan., district judge last month dismissed the charges on a jurisdictional issue at the request Sedgwick County District Attorney Nola Foulston (D), and McKinney filed an appeal to the state Supreme Court. Morrison, who defeated Kline in the November 2006 election, said he does not plan to withdraw McKinney's request. According to the AP/Eagle, the evidence against Tiller includes records from 60 patients who visited Women's Health Care Services (AP/Wichita Eagle, 1/8).
Morrison Fires McKinney, Reaction
Morrison on Tuesday sent a letter to McKinney ordering him "to cease and desist of any further activity" in regard to the Tiller case, the AP/Forbes reports (Hanna, AP/Forbes, 1/9). Morrison said he will demand McKinney return the medical records and any copies he might have made. "I do have concerns about how many copies have been made of [the medical records] and who's got possession of them," Morrison said. He added that his office will give the allegations against Tiller "a really good review" no matter how the state Supreme Court rules on McKinney's appeal. Tiller's attorneys have said the allegations are unfounded (AP/Wichita Eagle, 1/8). "Morrison said he would fire me because I was not a 'neutral third party;' that's a smoke screen," McKinney said adding, "Nobody is neutral about aborting late-term babies. A special prosecutor isn't supposed to be neutral, he's supposed to prosecute the defendant." Kline in a statement Tuesday said Morrison "fired an independent prosecutor with a well-respected legal career and terminated the contract that provided that prosecutor with independent authority." McKinney's last day as special prosecutor will be Saturday (AP/Forbes, 1/9).
"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.
ASRM Revises Guidelines On Limiting Embryo Transfer For Assisted Reproductive Technology Procedures To Reduce Multiple Births
The American Society of Reproductive Medicine and the Society for Assisted Reproductive Technology on Tuesday released revised guidelines for assisted reproductive therapies embryo transfer that recommend transferring no more than two embryos during a single procedure for women younger than age 35, Reuters reports (Reuters, 10/24). ASRM in 1999 released guidelines recommending the transfer of only two embryos for women younger than age 35 with a "healthy" prognosis and three embryos for women with a poorer prognosis for successful implantation. The organization in 2004 updated the guidelines to say that women under 35 with a good prognosis should consider implanting only one embryo (Kaiser Daily Women's Health Policy Report, 7/7). The new guidelines say that women under 35 should always be given no more than two embryos during a single implantation procedure "in the absence of extraordinary circumstances" (ASRM guidelines, November 2006). The guidelines also say that women ages 35 to 37 should receive no more than two to three embryos, that women ages 38 to 40 should receive no more than four and that women over age 40 should receive five or fewer embryos during an implantation procedure (Reuters, 10/24). "The evidence clearly indicates that we can reduce the number of high order multiple gestations and still maintain high pregnancy rates," Marc Fitz, chair of the ASRM Practice Committee, said, adding, "That is and will remain the goal of these guidelines" (ASRM release, 10/24). March of Dimes Medical Director Nancy Green in a statement said, "Limiting the number of transferred embryos will mean fewer higher order multiple gestations, defined as three or more fetuses, and reduce the risk of complications for both the mother and the fetus, including preterm birth." According to the March of Dimes, more than one-third of all pregnancies resulting from in vitro fertilization or another form of ART result in a multiple birth (March of Dimes release, 10/24).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"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.
ADHD Stimulant Treatment May Decrease Risk Of Substance Abuse In Adolescent Girls
Massachusetts General Hospital (MGH) researchers have found that treatment with stimulant drugs does not increase and appears to significantly decrease the risk that girls with ADHD will begin smoking cigarettes or using alcohol or drugs. Their report in the October Archives of Pediatrics and Adolescent Medicine parallels the findings of several earlier studies in boys, which needed to be confirmed in girls.
"Girls with ADHD actually tend to get into trouble with substance abuse earlier than do boys with the disorder, so confirming those results was not simply academic," says Timothy Wilens, MD, director of the Substance Abuse Program in the MGH Pediatric Psychopharmacology Department, who led the study. "This is also one of the first naturalistic studies showing reduced risk of cigarette smoking in adolescents being treated for ADHD and is consistent with a 2006 prospective trial of ours that found that participants receiving stimulant treatment had less risk of smoking than those not receiving stimulants."
It is well known that individuals with ADHD have a significantly increased risk for cigarette smoking and substance abuse, and concerns that treatment with stimulant drugs may increase the risk of drug or alcohol abuse have often been expressed. Wilens and his MGH colleagues have conducted several studies in boys and young men with ADHD, the overall conclusions of which are that stimulant treatment decreases the risk and delays the onset of substance abuse in adolescence but neither increases nor reduces the risk of using tobacco, alcohol or drugs in adulthood. Evidence on treatment's impact for girls has been limited and conflicting, with at least one study suggesting the ADHD-associated risk may persist in spite of treatment.
Using data from a larger, long-term investigation of the impact of ADHD on the risk of substance abuse in girls, the researchers analyzed information from 114 participants with ADHD who had enrolled at the ages of 6 to 18. Standardized assessments for the use, abuse and dependence on tobacco, alcohol, marijuana or other drugs were conducted 5 years after initial study enrollment. Comparing results from the 94 participants who received stimulant treatment with the 20 who had not been treated indicated that treatment cut in half the risk of smoking, drinking alcohol or drug abuse. In participants who did develop substance abuse, whether or not they had received stimulant treatment had no effect on factors like when they began using substances and the level of dependence.
"Right now we can't say if the observed protective effect of stimulant treatment will continue into adulthood or disappear as it did in our studies in young men," Wilens explains. "But we suspect that the longer a girl is successfully treated for ADHD, the more likely she is to be at reduced risk for smoking and substance use or abuse. We can confidently say that stimulant treatment does not increase the risk of future substance abuse or smoking in girls with ADHD and at least delays the onset of cigarette smoking and substance abuse." Wilens is an associate professor of Psychiatry at Harvard Medical School.
The current study was supported by grants from the National Institutes of Health and the Lilly Foundation. Co-authors of the report are Joel Adamson, Michael Monuteaux, ScD, Mary Schillinger, Diane Westerberg, and Joseph Biederman, MD, of the MGH Pediatric Psychopharmacology Department; and Steven Faraone, PhD, State University of New York Upstate Medical Center. At the time this study was performed, Wilens received significant income from Novartis; Massachusetts General Hospital has managed this conflict.
Massachusetts General Hospital (massgeneral/), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
Source: Sue McGreevey
Massachusetts General Hospital
"Girls with ADHD actually tend to get into trouble with substance abuse earlier than do boys with the disorder, so confirming those results was not simply academic," says Timothy Wilens, MD, director of the Substance Abuse Program in the MGH Pediatric Psychopharmacology Department, who led the study. "This is also one of the first naturalistic studies showing reduced risk of cigarette smoking in adolescents being treated for ADHD and is consistent with a 2006 prospective trial of ours that found that participants receiving stimulant treatment had less risk of smoking than those not receiving stimulants."
It is well known that individuals with ADHD have a significantly increased risk for cigarette smoking and substance abuse, and concerns that treatment with stimulant drugs may increase the risk of drug or alcohol abuse have often been expressed. Wilens and his MGH colleagues have conducted several studies in boys and young men with ADHD, the overall conclusions of which are that stimulant treatment decreases the risk and delays the onset of substance abuse in adolescence but neither increases nor reduces the risk of using tobacco, alcohol or drugs in adulthood. Evidence on treatment's impact for girls has been limited and conflicting, with at least one study suggesting the ADHD-associated risk may persist in spite of treatment.
Using data from a larger, long-term investigation of the impact of ADHD on the risk of substance abuse in girls, the researchers analyzed information from 114 participants with ADHD who had enrolled at the ages of 6 to 18. Standardized assessments for the use, abuse and dependence on tobacco, alcohol, marijuana or other drugs were conducted 5 years after initial study enrollment. Comparing results from the 94 participants who received stimulant treatment with the 20 who had not been treated indicated that treatment cut in half the risk of smoking, drinking alcohol or drug abuse. In participants who did develop substance abuse, whether or not they had received stimulant treatment had no effect on factors like when they began using substances and the level of dependence.
"Right now we can't say if the observed protective effect of stimulant treatment will continue into adulthood or disappear as it did in our studies in young men," Wilens explains. "But we suspect that the longer a girl is successfully treated for ADHD, the more likely she is to be at reduced risk for smoking and substance use or abuse. We can confidently say that stimulant treatment does not increase the risk of future substance abuse or smoking in girls with ADHD and at least delays the onset of cigarette smoking and substance abuse." Wilens is an associate professor of Psychiatry at Harvard Medical School.
The current study was supported by grants from the National Institutes of Health and the Lilly Foundation. Co-authors of the report are Joel Adamson, Michael Monuteaux, ScD, Mary Schillinger, Diane Westerberg, and Joseph Biederman, MD, of the MGH Pediatric Psychopharmacology Department; and Steven Faraone, PhD, State University of New York Upstate Medical Center. At the time this study was performed, Wilens received significant income from Novartis; Massachusetts General Hospital has managed this conflict.
Massachusetts General Hospital (massgeneral/), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
Source: Sue McGreevey
Massachusetts General Hospital
Treatments Used To Remove Abnormal Cervical Cells Increase Risk For Problems During Pregnancy, Study Says
Treatments used to remove abnormal cervical cells increase a woman's risk for problems during pregnancy, according to a study published on Friday in the journal Lancet, Reuters reports. Maria Kyrgiou of Queen Charlotte's and Chelsea Hospital in London and colleagues looked at 27 previous studies that examined treatments used to remove abnormal cells from the cervix (Reuters, 2/10). Researchers compared the different methods to remove tissue, including cold knife or laser conization, in which a conical sample of tissue is removed; laser ablation, in which a laser is used to remove the tissue; and a loop electrosurgical excision procedure, in which tissue is removed using a wire loop and a low-level electrical current. The study finds that women undergoing cold knife conization were two-and-a-half times as likely to deliver prematurely or deliver a low-birthweight infant and three times as likely to deliver by caesarean section as women who did not undergo cold knife conization, according to HealthDay News/Forbes. Women undergoing LEEP were between 70% and 80% more likely to deliver prematurely or deliver a low-birthweight infant and almost three times as likely to experience a rupture of the cervical membranes compared with women who did not undergo LEEP, HealthDay News/Forbes reports. Researchers also found that women undergoing laser ablation were not at an increased risk for complications compared with women who did not undergo laser ablation, according to HealthDay News/Forbes (HealthDay News/Forbes, 2/9). Kyrgiou said, "This information should be considered when counseling women before their consent to treatment and lends support to the philosophy of doctors not treating young women with mild abnormalities," adding that the findings "probably favor" beginning cervical screening after age 25 "with respect to long-term obstetric outcomes" (Reuters, 2/10).
"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.
"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.
Health Undervalued In Reproductive Rights Debate: Study
Women's health is increasingly undervalued in conflicts over reproductive rights, including clashes based on moral objections under so-called conscience clauses, a new study by a University of Illinois legal expert found.
Beth Burkstrand-Reid says a review of recent reproductive rights cases shows that judges may shortchange women's health when it is pitted against other legal interests, such as religious freedom, potentially leading to rulings that could put health at risk.
"Judges may understandably be reluctant to decide who wins in a battle between religious freedom, doctor's rights and women's health," she said. "As a result, they may downplay women's health as an interest, and thus fail to fully consider it in their decisions."
Burkstrand-Reid says women's health will remain at risk even if President Obama rescinds a federal conscience rule this month, as expected. Several states have their own laws on the books, she said, and others may consider legislation to fill the federal void.
"What we are seeing is a battle over whether laws should prioritize women's health or if by doing that the government is impermissibly impinging on moral or religious freedoms," she said. "I don't expect that this controversy will go away anytime soon."
Burkstrand-Reid's study, which will appear in the University of Colorado Law Review, found that some courts cite the availability of alternative reproductive health providers or services as proof that women's health will not suffer even in the face of laws that restrict reproductive health care.
That reasoning can be flawed, said Burkstrand-Reid, a visiting professor in the U. of I. College of Law who studies family and gender law.
She cited a ruling that allowed pharmacists to refuse to provide the morning-after pill under certain circumstances based on the judge's reasoning that other pharmacies in the area stocked the contraceptive, thus protecting women's health in the event of a druggist refusal.
But Burkstrand-Reid says the ruling failed to adequately consider the possibility that a woman could become pregnant because of the delay caused by a pharmacist's refusal, or that druggists at the other outlets might also refuse.
"When women need the morning-after pill, the clock is ticking to prevent pregnancy," she said. "In these situations, you can see a direct clash between women's health and assertions of religious freedom. Increased pharmacist refusal to provide contraception and other actions like it are exactly what reproductive health advocates fear happening nationwide if conscience clauses become the norm."
In another case, a judge upheld a law that would shutter a rural abortion provider, citing services available at another clinic 70 miles away as adequately protecting women's interests. But the ruling did not adequately consider factors such as costs or lack of transportation that could potentially delay the procedure and heighten risks, Burkstrand-Reid said.
Other cases blame women themselves when services are denied, such as when women are refused vaginal delivery and forced instead to have cesarean sections because judges reason they should have addressed that question sooner.
"We pay a lot of attention to questions concerning access to abortion, birth control and other reproductive services," Burkstrand-Reid said. "What we're not closely considering, however, is how those restrictions on access can impact women's health."
Notes:
Burkstrand-Reid's study, "The Invisible Woman: Availability and Culpability in Reproductive Health Jurisprudence," is available online at papers.ssrn/sol3/papers.cfm?abstract_id=1345824.
Source:
Jan Dennis
University of Illinois at Urbana-Champaign
Beth Burkstrand-Reid says a review of recent reproductive rights cases shows that judges may shortchange women's health when it is pitted against other legal interests, such as religious freedom, potentially leading to rulings that could put health at risk.
"Judges may understandably be reluctant to decide who wins in a battle between religious freedom, doctor's rights and women's health," she said. "As a result, they may downplay women's health as an interest, and thus fail to fully consider it in their decisions."
Burkstrand-Reid says women's health will remain at risk even if President Obama rescinds a federal conscience rule this month, as expected. Several states have their own laws on the books, she said, and others may consider legislation to fill the federal void.
"What we are seeing is a battle over whether laws should prioritize women's health or if by doing that the government is impermissibly impinging on moral or religious freedoms," she said. "I don't expect that this controversy will go away anytime soon."
Burkstrand-Reid's study, which will appear in the University of Colorado Law Review, found that some courts cite the availability of alternative reproductive health providers or services as proof that women's health will not suffer even in the face of laws that restrict reproductive health care.
That reasoning can be flawed, said Burkstrand-Reid, a visiting professor in the U. of I. College of Law who studies family and gender law.
She cited a ruling that allowed pharmacists to refuse to provide the morning-after pill under certain circumstances based on the judge's reasoning that other pharmacies in the area stocked the contraceptive, thus protecting women's health in the event of a druggist refusal.
But Burkstrand-Reid says the ruling failed to adequately consider the possibility that a woman could become pregnant because of the delay caused by a pharmacist's refusal, or that druggists at the other outlets might also refuse.
"When women need the morning-after pill, the clock is ticking to prevent pregnancy," she said. "In these situations, you can see a direct clash between women's health and assertions of religious freedom. Increased pharmacist refusal to provide contraception and other actions like it are exactly what reproductive health advocates fear happening nationwide if conscience clauses become the norm."
In another case, a judge upheld a law that would shutter a rural abortion provider, citing services available at another clinic 70 miles away as adequately protecting women's interests. But the ruling did not adequately consider factors such as costs or lack of transportation that could potentially delay the procedure and heighten risks, Burkstrand-Reid said.
Other cases blame women themselves when services are denied, such as when women are refused vaginal delivery and forced instead to have cesarean sections because judges reason they should have addressed that question sooner.
"We pay a lot of attention to questions concerning access to abortion, birth control and other reproductive services," Burkstrand-Reid said. "What we're not closely considering, however, is how those restrictions on access can impact women's health."
Notes:
Burkstrand-Reid's study, "The Invisible Woman: Availability and Culpability in Reproductive Health Jurisprudence," is available online at papers.ssrn/sol3/papers.cfm?abstract_id=1345824.
Source:
Jan Dennis
University of Illinois at Urbana-Champaign
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