Women with stress urinary incontinence (SUI) treated using muscle-derived stem cell injections to strengthen their sphincter muscles experience long-term improvements in their condition, according to a study led by researchers at the University of Pittsburgh School of Medicine and Sunnybrook Health Sciences Centre in Toronto. The study, which followed patients for more than one year, suggests that the approach is safe, improves patients' quality of life and may be an effective treatment for SUI. The findings were presented at the Tissue Engineering and Regenerative Medicine in Urology press briefing at the annual meeting of the American Urological Association (AUA) in San Diego, and is published in Abstract 1331 in the AUA proceedings.
"This clinical trial is extremely encouraging, given that 13 million people in the United States, most of them women, cope with stress urinary incontinence," said Michael B. Chancellor, M.D., the study's senior author and professor of urology and gynecology at the University of Pittsburgh School of Medicine. "We're demonstrating for the first time that we may be able to offer people with SUI a long-term and minimally invasive treatment option."
"The technique to achieve optimal efficacy is evolving, but we are pleased with what this study has shown," added principal investigator Lesley Carr, M.D., urologist at Sunnybrook Health Sciences Centre and assistant professor at the University of Toronto. "We now have preliminary evidence that stem cells are safe to use and appear to improve female stress urinary incontinence."
Previous studies in animal models of SUI completed at the University of Pittsburgh School of Medicine demonstrated that injecting stem cells into the urethral muscles increases leak point pressure, leading to the restoration of the deficient muscles. The results of these studies formed the basis for the clinical trial.
In the study, Dr. Carr and colleagues took biopsies of skeletal muscle tissue from eight female patients and isolated and expanded the stem cells from the tissue in culture. In an outpatient setting, the patients then received injections of the muscle-derived stem cells into the area surrounding the urethra. Each patient received an equal dose of stem cell injections using three different injection techniques - a transurethral injection with either an 8-mm or 10-mm needle or a periurethral injection.
Five of the eight women who participated in the study reported improvement in bladder control and quality of life with no serious short- or long-term adverse effects one year after the initial treatment. These improvements were associated with both the 10-mm needle injections and the periurethral injections, which allowed the investigators to deliver the stem cells close to the damaged sphincter muscle. The 8-mm needle was not able to deliver the muscle stem cells deep enough into the tissue to reach the sphincter.
A multi-center study in Canada and a study in the United States are currently underway and will allow researchers to determine the optimal dose of muscle stem cells needed to effectively treat SUI.
Women with SUI involuntarily leak urine during activities that put pressure on the bladder, such as running, coughing, sneezing or laughing. Stress incontinence is caused by childbirth, menopause or pelvic surgery and is most often diagnosed in women during middle-age.
CONTACT: Natalie Chung-Sayers,
Sunnybrook Health Sciences Centre
In addition to Drs. Carr and Chancellor, other contributors to the study included Deborah Steele and Shannon Steele, with Sunnybrook Health Sciences Centre; Janet Erickson and Wendy Leng, M.D., with the University of Pittsburgh; and David Wagner, Ryan Pruchnic and Ron Jankowski with Cook MyoSite Inc. The study was funded by Cook MyoSite Inc. of Pittsburgh. Dr. Chancellor serves as a paid consultant to CookMyoSite and maintains a financial interest in the company.
Contact: Clare Collins
University of Pittsburgh Schools of the Health Sciences
четверг, 19 апреля 2012 г.
четверг, 12 апреля 2012 г.
Blogs Comment On HHS Conscience Rule, Frozen Embryos, 'Mexico City' Policy
The following summarizes selected women's health-related blog entries.
~ "Repeal the Global Gag Rule," Rep. Nita Lowey (D-N.Y.), Huffington Post blogs: President-elect Barack Obama and the new Congress "can place American foreign policy firmly on the side of free speech, of women's health, and of doctors and care providers who understand that family planning is a cornerstone of social stability, economic growth and public health in the developing world" by repealing the "global gag rule," also called the Mexico City policy, Lowey writes in a blog entry. This step can be done "quickly, simply, cleanly, without a penny of cost to the taxpayers," she adds. The rule would be "patently unconstitutional" if applied in the U.S., Lowey writes. She continues, "Abroad, [the rule] is responsible for untold misery and, in tragic irony, has almost certainly increased the number of unintended pregnancies and put millions of women's and children's lives at risk." Lowey writes that as a Representative, her "fight to overturn [the rule] has been stymied by Republican majorities" and threatened by a veto from President Bush. She writes that she looks forward to working with the Obama administration to finally repeal the rule, concluding, "Few actions would benefit more people with less effort, or send a more dramatic signal to the world that America is prepared once again to be a leader for individual rights, personal dignity and commonsense policy that saves lives" (Lowey, Huffington Post blogs, 12/11).
~ "Conscience Clauses: Justifying Bigotry on Religious Grounds," Pamela Merritt, RH Reality Check: Merritt writes, "The thought of people refusing to serve a person of color due to their personal objection to desegregation is now considered indefensible and a violation of the law, but refusal of service due to personal religious objections is not a thing of the past." Refusals to provide health care services or fill prescriptions are "threats to the rights and health of women, and defending against those threats and the erosion of rights that they represent is a crucial front in the reproductive justice struggle," according to Merritt. She writes that a "key question" regarding health care conscience rules -- which allow providers to refuse services based on moral or religious beliefs -- is "whether a health care insurance provider can refuse to cover services on religious grounds if they receive federal funds." One example is the Catholic health care system, which the group Catholics for Choice has examined in a report, Merritt writes. According to Merritt, the report found that there are "few formal regulations that require health plans that refuse to provide family planning services to disclose this clearly on marketing and enrollment materials," which can lead employers to "select a plan and have no idea that it limits or denies access to reproductive health care due to a lack of coverage." She continues, "It's not as if there aren't ways to balance individual freedoms," noting that the report identified several methods for Catholic health care plans to offer access to reproductive health services "without compromising their ... beliefs." She writes that the "key element" for Catholic systems is "distancing the Catholic plan from the direct provision of and/or direct payment for forbidden services," such as by contracting with a non-Catholic provider or arranging payment for reproductive health services through a third party (Merritt, RH Reality Check, 12/11).
~ "'Embryos on Ice' ... and Other Absurdities," Judie Brown, American Life League blog: The "most heartless" term used to describe "preborn children" is "'Embryos on Ice,'" Brown writes in response to recent news coverage regarding options for excess frozen embryos created for fertility treatments. Brown writes that "we are talking about children," not "'fertilized eggs' or 'leftovers' or rejects tossed off an assembly line." She continues that the parents of these embryos "have unwittingly contributed to the ongoing growth of the culture of death by agreeing with the hypothesis that there are embryonic children who are somehow less human than those who were implanted in their mom and brought to term ... as if there are some embryonic children who are really children and others who are not." Fertility treatments are creating a "dehumanization" that is "unhealthy for parents, the children that have been welcomed and the children who may be killed ... or simply left in a tray somewhere to die," she writes. She concludes, "By restoring the legal recognition of personhood to every innocent human being from his beginning, practices such as [in vitro fertilization] will cease, because every human embryo will have the very same rights you and I have" (Brown, American Life League blog, 12/10).
~ "Pro-Lifers Love Babies So Much They Want To Defund Planned Parenthood So That You Get Pregnant," Feministe: "For most of us, the fact that [Planned Parenthood] provides contraception to low-income women and teenagers is a good thing, because it means fewer unwanted pregnancies (and fewer abortions)," a Feministe blog entry says. Although abortion services comprise only 3% of Planned Parenthood's budget, "for anti-choice leaders, contraception and abortion are part of the same problem: They allow women to 'get away' with having sex, and that is a big problem in their ideal world." The blog continues that people are losing their health insurance coverage because of the current economic crisis and high unemployment rate, adding that it is "abhorrent that anti-choicers would choose this moment to try and strip resources to one of the country's largest providers of reproductive health care -- especially a provider that offers crucial services like contraception and cancer screenings." The blog concludes, "Shame on anti-choicers for their politically motivated targeting of [Planned Parenthood] -- and their attempts to block low-income women from accessing basic reproductive care" (Feministe, 12/11).
~ "W's Parting Gifts to Women," Martha Burk, Huffington Post blogs: President Bush is giving women "some new regulations that will keep on giving us trouble for years to come" before he leaves office, Burk writes in a blog entry. Burk adds that Bush is "deputizing health workers as watchdogs" through the proposed HHS conscience rule, which would permit health providers who receive federal grants to opt out of medical care based on their moral or religious beliefs, because he "know[s] that the country is not inclined to support new laws against abortion." Another "gift" Bush is giving women is "a weakening of our already very weak" Family and Medical Leave Act by "making it harder for workers to exercise their rights" under the law, Burk writes. Bush also is giving "new premiums and higher co-payments for Medicaid" to low-income women, Burk says, adding that experts have predicted the changes will "cause Medicaid patients to go without medical services." Burk adds, "[W]ith the economy in shambles and two wars to worry about, these concerns will most likely be pushed to the bottom of the pile for at least a couple of years," concluding, "After that, the process [to overturn the regulations] could take up to a year and a half" (Burk, Huffington Post blogs, 12/11).
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.
© 2008 The Advisory Board Company. All rights reserved.
~ "Repeal the Global Gag Rule," Rep. Nita Lowey (D-N.Y.), Huffington Post blogs: President-elect Barack Obama and the new Congress "can place American foreign policy firmly on the side of free speech, of women's health, and of doctors and care providers who understand that family planning is a cornerstone of social stability, economic growth and public health in the developing world" by repealing the "global gag rule," also called the Mexico City policy, Lowey writes in a blog entry. This step can be done "quickly, simply, cleanly, without a penny of cost to the taxpayers," she adds. The rule would be "patently unconstitutional" if applied in the U.S., Lowey writes. She continues, "Abroad, [the rule] is responsible for untold misery and, in tragic irony, has almost certainly increased the number of unintended pregnancies and put millions of women's and children's lives at risk." Lowey writes that as a Representative, her "fight to overturn [the rule] has been stymied by Republican majorities" and threatened by a veto from President Bush. She writes that she looks forward to working with the Obama administration to finally repeal the rule, concluding, "Few actions would benefit more people with less effort, or send a more dramatic signal to the world that America is prepared once again to be a leader for individual rights, personal dignity and commonsense policy that saves lives" (Lowey, Huffington Post blogs, 12/11).
~ "Conscience Clauses: Justifying Bigotry on Religious Grounds," Pamela Merritt, RH Reality Check: Merritt writes, "The thought of people refusing to serve a person of color due to their personal objection to desegregation is now considered indefensible and a violation of the law, but refusal of service due to personal religious objections is not a thing of the past." Refusals to provide health care services or fill prescriptions are "threats to the rights and health of women, and defending against those threats and the erosion of rights that they represent is a crucial front in the reproductive justice struggle," according to Merritt. She writes that a "key question" regarding health care conscience rules -- which allow providers to refuse services based on moral or religious beliefs -- is "whether a health care insurance provider can refuse to cover services on religious grounds if they receive federal funds." One example is the Catholic health care system, which the group Catholics for Choice has examined in a report, Merritt writes. According to Merritt, the report found that there are "few formal regulations that require health plans that refuse to provide family planning services to disclose this clearly on marketing and enrollment materials," which can lead employers to "select a plan and have no idea that it limits or denies access to reproductive health care due to a lack of coverage." She continues, "It's not as if there aren't ways to balance individual freedoms," noting that the report identified several methods for Catholic health care plans to offer access to reproductive health services "without compromising their ... beliefs." She writes that the "key element" for Catholic systems is "distancing the Catholic plan from the direct provision of and/or direct payment for forbidden services," such as by contracting with a non-Catholic provider or arranging payment for reproductive health services through a third party (Merritt, RH Reality Check, 12/11).
~ "'Embryos on Ice' ... and Other Absurdities," Judie Brown, American Life League blog: The "most heartless" term used to describe "preborn children" is "'Embryos on Ice,'" Brown writes in response to recent news coverage regarding options for excess frozen embryos created for fertility treatments. Brown writes that "we are talking about children," not "'fertilized eggs' or 'leftovers' or rejects tossed off an assembly line." She continues that the parents of these embryos "have unwittingly contributed to the ongoing growth of the culture of death by agreeing with the hypothesis that there are embryonic children who are somehow less human than those who were implanted in their mom and brought to term ... as if there are some embryonic children who are really children and others who are not." Fertility treatments are creating a "dehumanization" that is "unhealthy for parents, the children that have been welcomed and the children who may be killed ... or simply left in a tray somewhere to die," she writes. She concludes, "By restoring the legal recognition of personhood to every innocent human being from his beginning, practices such as [in vitro fertilization] will cease, because every human embryo will have the very same rights you and I have" (Brown, American Life League blog, 12/10).
~ "Pro-Lifers Love Babies So Much They Want To Defund Planned Parenthood So That You Get Pregnant," Feministe: "For most of us, the fact that [Planned Parenthood] provides contraception to low-income women and teenagers is a good thing, because it means fewer unwanted pregnancies (and fewer abortions)," a Feministe blog entry says. Although abortion services comprise only 3% of Planned Parenthood's budget, "for anti-choice leaders, contraception and abortion are part of the same problem: They allow women to 'get away' with having sex, and that is a big problem in their ideal world." The blog continues that people are losing their health insurance coverage because of the current economic crisis and high unemployment rate, adding that it is "abhorrent that anti-choicers would choose this moment to try and strip resources to one of the country's largest providers of reproductive health care -- especially a provider that offers crucial services like contraception and cancer screenings." The blog concludes, "Shame on anti-choicers for their politically motivated targeting of [Planned Parenthood] -- and their attempts to block low-income women from accessing basic reproductive care" (Feministe, 12/11).
~ "W's Parting Gifts to Women," Martha Burk, Huffington Post blogs: President Bush is giving women "some new regulations that will keep on giving us trouble for years to come" before he leaves office, Burk writes in a blog entry. Burk adds that Bush is "deputizing health workers as watchdogs" through the proposed HHS conscience rule, which would permit health providers who receive federal grants to opt out of medical care based on their moral or religious beliefs, because he "know[s] that the country is not inclined to support new laws against abortion." Another "gift" Bush is giving women is "a weakening of our already very weak" Family and Medical Leave Act by "making it harder for workers to exercise their rights" under the law, Burk writes. Bush also is giving "new premiums and higher co-payments for Medicaid" to low-income women, Burk says, adding that experts have predicted the changes will "cause Medicaid patients to go without medical services." Burk adds, "[W]ith the economy in shambles and two wars to worry about, these concerns will most likely be pushed to the bottom of the pile for at least a couple of years," concluding, "After that, the process [to overturn the regulations] could take up to a year and a half" (Burk, Huffington Post blogs, 12/11).
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.
© 2008 The Advisory Board Company. All rights reserved.
четверг, 5 апреля 2012 г.
Rights To Commercialise World's First Contraceptive Spray Acquired By Acrux
Acrux (ASX:ACR), the Australian company with patient-preferred technology for delivering drugs across the skin, today announced an agreement with the New York-based Population Council, Inc. The agreement enables Acrux to progress toward commercialisation of a unique contraceptive spray, containing the new-generation contraceptive drug Nestorone?®.
Under the agreement, Acrux has a worldwide licence from the Population Council to intellectual property covering the use of Nestorone?® with Acrux's patented metered-dose skin spray delivery technology (MDTS?®). Acrux will develop and commercialise Nestorone?® MDTS?® and has the right to sub-license to commercial partners. In addition to commercial distribution of the product, Acrux (or its sub-licensees) will make Nestorone?® MDTS?® available at reduced prices to public sector organisations providing human reproductive health products to disadvantaged people.
Results of a Phase 1 clinical trial, conducted by Acrux last year under a development agreement with the Population Council, showed that a once daily application of Nestorone?® MDTS?® provides the level of Nestorone?® in the blood known to be effective for contraception. A Phase 2 trial, scheduled to start in the second half of 2006, aims to demonstrate that Nestorone?® MDTS?® controls ovulation. Acrux will seek commercial partners for the remaining steps in global commercialisation.
"This exciting product will give women a very attractive new option for contraception. It combines our unique technology with the know-how of one of the world's leading developers of reproductive health products," said Acrux CEO Igor Gonda.
"The target features of Nestorone?® MDTS?® are: a convenient daily spray onto the arm that is more discreet and less irritating to the skin than a patch, and we believe, will prove to have a better safety profile than other hormonal contraceptives. Market research has shown that many women will prefer the ease and convenience of this method to swallowing pills, taking injections, or wearing patches," he added.
Gonda also noted that Acrux sees great market potential for Nestorone?® MDTS?® given the fact that annual worldwide sales of hormonal contraceptives exceed US$4 billion, and sales of transdermal contraceptive patches in the United States alone are more than US$400 million a year.
Population Council CEO Peter Donaldson said he was pleased with the progress Acrux had made in the validation of its transdermal spray technology platform in clinical trials, especially in the area of women's health. "We are very encouraged by the results obtained so far with the Nestorone?® spray. An important part of the Population Council's mission is to meet the need for reproductive healthcare products on a global scale, and we believe that Acrux's technology can be an attractive option for many women around the world."
Acrux has two other products in its women's health portfolio that are delivered as daily sprays; Evamist for menopausal symptoms and Testosterone MDTS?® for decreased libido. Both are in advanced stages of development.
About Nestorone?® MDTS?®
Nestorone?®, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS?® is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug via the skin. The spray applicator is placed gently against the forearm and an actuator button is pushed. A light spray containing a proprietary formulation of Nestorone?® is quickly absorbed into the skin. Nestorone?® is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen. The spray is fast-drying, non-irritating, and invisible after application.
About Acrux
acrux.au/
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
Acrux's product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders and a contraceptive. 20 human clinical trials have been completed with 8 different drugs and the lead product, Evamist, is nearing the end of a phase 3 trial in the USA.
Acrux has licensed USA rights for Evamist (Estradiol MDTS?®) and Testosterone MDTS?® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS?® and Fentanyl UDTS to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.
About the Population Council popcouncil/
The Population Council, an international, non-profit, non-governmental organisation, seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Population Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
The Population Council has a proven track record in the successful development of female contraceptive products and has worked to make them accessible to people in developing countries. Three of the four major longacting reversible contraceptives available today were developed by the Population Council: the Copper T IUD, Norplant?®, Jadelle?®, and Mirena?®.
More than 50 million Copper T IUDs have been distributed in over 70 countries.
CONTACTS:
Acrux
USA: - Igor Gonda, CEO & Managing Director +61 439 811 339
Australia: - Jon Pilcher, CFO +61 3 8379 0100
New York: - Christina Pagano, Pagano & Company Public Relations
+1 212-213-2851; +1 646-382-3871 (mobile); PaganoPRaol
Population Council
Melissa May, Director, Public Information +1 212 339 0525
Contact: Igor Gonda
Research Australia
View drug information on Estradiol Transdermal System; Evamist; Mirena.
Under the agreement, Acrux has a worldwide licence from the Population Council to intellectual property covering the use of Nestorone?® with Acrux's patented metered-dose skin spray delivery technology (MDTS?®). Acrux will develop and commercialise Nestorone?® MDTS?® and has the right to sub-license to commercial partners. In addition to commercial distribution of the product, Acrux (or its sub-licensees) will make Nestorone?® MDTS?® available at reduced prices to public sector organisations providing human reproductive health products to disadvantaged people.
Results of a Phase 1 clinical trial, conducted by Acrux last year under a development agreement with the Population Council, showed that a once daily application of Nestorone?® MDTS?® provides the level of Nestorone?® in the blood known to be effective for contraception. A Phase 2 trial, scheduled to start in the second half of 2006, aims to demonstrate that Nestorone?® MDTS?® controls ovulation. Acrux will seek commercial partners for the remaining steps in global commercialisation.
"This exciting product will give women a very attractive new option for contraception. It combines our unique technology with the know-how of one of the world's leading developers of reproductive health products," said Acrux CEO Igor Gonda.
"The target features of Nestorone?® MDTS?® are: a convenient daily spray onto the arm that is more discreet and less irritating to the skin than a patch, and we believe, will prove to have a better safety profile than other hormonal contraceptives. Market research has shown that many women will prefer the ease and convenience of this method to swallowing pills, taking injections, or wearing patches," he added.
Gonda also noted that Acrux sees great market potential for Nestorone?® MDTS?® given the fact that annual worldwide sales of hormonal contraceptives exceed US$4 billion, and sales of transdermal contraceptive patches in the United States alone are more than US$400 million a year.
Population Council CEO Peter Donaldson said he was pleased with the progress Acrux had made in the validation of its transdermal spray technology platform in clinical trials, especially in the area of women's health. "We are very encouraged by the results obtained so far with the Nestorone?® spray. An important part of the Population Council's mission is to meet the need for reproductive healthcare products on a global scale, and we believe that Acrux's technology can be an attractive option for many women around the world."
Acrux has two other products in its women's health portfolio that are delivered as daily sprays; Evamist for menopausal symptoms and Testosterone MDTS?® for decreased libido. Both are in advanced stages of development.
About Nestorone?® MDTS?®
Nestorone?®, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS?® is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug via the skin. The spray applicator is placed gently against the forearm and an actuator button is pushed. A light spray containing a proprietary formulation of Nestorone?® is quickly absorbed into the skin. Nestorone?® is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen. The spray is fast-drying, non-irritating, and invisible after application.
About Acrux
acrux.au/
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
Acrux's product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders and a contraceptive. 20 human clinical trials have been completed with 8 different drugs and the lead product, Evamist, is nearing the end of a phase 3 trial in the USA.
Acrux has licensed USA rights for Evamist (Estradiol MDTS?®) and Testosterone MDTS?® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS?® and Fentanyl UDTS to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.
About the Population Council popcouncil/
The Population Council, an international, non-profit, non-governmental organisation, seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Population Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
The Population Council has a proven track record in the successful development of female contraceptive products and has worked to make them accessible to people in developing countries. Three of the four major longacting reversible contraceptives available today were developed by the Population Council: the Copper T IUD, Norplant?®, Jadelle?®, and Mirena?®.
More than 50 million Copper T IUDs have been distributed in over 70 countries.
CONTACTS:
Acrux
USA: - Igor Gonda, CEO & Managing Director +61 439 811 339
Australia: - Jon Pilcher, CFO +61 3 8379 0100
New York: - Christina Pagano, Pagano & Company Public Relations
+1 212-213-2851; +1 646-382-3871 (mobile); PaganoPRaol
Population Council
Melissa May, Director, Public Information +1 212 339 0525
Contact: Igor Gonda
Research Australia
View drug information on Estradiol Transdermal System; Evamist; Mirena.
четверг, 29 марта 2012 г.
Studies Confirm Long-term Protection Against Precancerous Cervical Lesions With Vaccines Against Human Papilloma Viruses (HPV)
Follow-up studies of two vaccines against HPV causing cervical cancer have shown long-term protection against precancerous lesions, according to results reported at the 2007 Annual Meeting of the American Association for Cancer Research (14-18 April, 2007; Los Angeles, USA).
Results from long-term follow-up of women vaccinated with a candidate vaccine against HPV types 16 and 18 (Cervarix, being developed by GlaxoSmithKline) showed 100% efficacy in preventing precancerous lesions due to these virus types for up to 5.5 years. The initial study was a double-blind, controlled trial of 1113 women (aged 15-25 years) who were randomised to receive three doses of the vaccine or placebo at 0, 1 and 6 months.
The extended follow-up included 776 women who were followed for up to 67 months. The vaccine induced a strong immune response in virtually 100% of women, which was sustained out to 5.5 years for both HPV types 16 and 18. At the end of the follow-up period, the average level of antibodies against both virus types was at least 11 times higher than those associated with natural infection.
Results showed 68% efficacy against precancerous lesions (CIN2+) and 38% efficacy against abnormal Pap smears, regardless of the type of cancer-causing virus detected. Further results showed that the vaccine provided significant protection against genetically similar viruses, with 88% efficacy against HPV 45 and 54% against HPV 31.
Stanley Gall, professor of obstetrics, gynaecology and women's health at the University of Louisville, Kentucky, USA, reported: "These new data demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date. They are exciting for the prevention of cervical cancer in women around the world."
Results from long-term follow-up of women given a quadrivalent HPV vaccine (Gardasil) also demonstrated sustained protection against precancerous lesions. A total of 21,000 women (16-25 years) in four cohorts have now been randomised to vaccine or placebo at day 1, and months 2 and 6. Efficacy in women receiving all three doses was 99-100%.
The vaccine proved highly effective against cervical intraepithelial neoplasia grades 2 and 3, precancerous lesions that are frequently caused by HPV 16. Only a single woman in the vaccine group presented with an early HPV type 16 lesion, compared to 42 in the placebo group with HPV 16 or 18 related cervical intraepithelial neoplasias of grades 2 or 3, or adenocarcinoma.
Darron Brown, professor of medicine, microbiology and immunology at Indiana University School of Medicine, reported: "After three years, we see that the vaccine remains highly effective against HPV 16 and 18 related precancerous cervical and other genital lesions caused by these HPV types. The high degree of efficacy and safety of this vaccine is remarkable." He noted that results from a study of cross-protection were 'very encouraging' but would not be available for a few more weeks.
: Susan Mayor PhD
Freelance medical journalist
View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.
Results from long-term follow-up of women vaccinated with a candidate vaccine against HPV types 16 and 18 (Cervarix, being developed by GlaxoSmithKline) showed 100% efficacy in preventing precancerous lesions due to these virus types for up to 5.5 years. The initial study was a double-blind, controlled trial of 1113 women (aged 15-25 years) who were randomised to receive three doses of the vaccine or placebo at 0, 1 and 6 months.
The extended follow-up included 776 women who were followed for up to 67 months. The vaccine induced a strong immune response in virtually 100% of women, which was sustained out to 5.5 years for both HPV types 16 and 18. At the end of the follow-up period, the average level of antibodies against both virus types was at least 11 times higher than those associated with natural infection.
Results showed 68% efficacy against precancerous lesions (CIN2+) and 38% efficacy against abnormal Pap smears, regardless of the type of cancer-causing virus detected. Further results showed that the vaccine provided significant protection against genetically similar viruses, with 88% efficacy against HPV 45 and 54% against HPV 31.
Stanley Gall, professor of obstetrics, gynaecology and women's health at the University of Louisville, Kentucky, USA, reported: "These new data demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date. They are exciting for the prevention of cervical cancer in women around the world."
Results from long-term follow-up of women given a quadrivalent HPV vaccine (Gardasil) also demonstrated sustained protection against precancerous lesions. A total of 21,000 women (16-25 years) in four cohorts have now been randomised to vaccine or placebo at day 1, and months 2 and 6. Efficacy in women receiving all three doses was 99-100%.
The vaccine proved highly effective against cervical intraepithelial neoplasia grades 2 and 3, precancerous lesions that are frequently caused by HPV 16. Only a single woman in the vaccine group presented with an early HPV type 16 lesion, compared to 42 in the placebo group with HPV 16 or 18 related cervical intraepithelial neoplasias of grades 2 or 3, or adenocarcinoma.
Darron Brown, professor of medicine, microbiology and immunology at Indiana University School of Medicine, reported: "After three years, we see that the vaccine remains highly effective against HPV 16 and 18 related precancerous cervical and other genital lesions caused by these HPV types. The high degree of efficacy and safety of this vaccine is remarkable." He noted that results from a study of cross-protection were 'very encouraging' but would not be available for a few more weeks.
: Susan Mayor PhD
Freelance medical journalist
View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.
четверг, 22 марта 2012 г.
Toronto Star Profiles Work Of Women's HIV/AIDS Advocacy Group In Namibia
The Toronto Star on Wednesday profiled the work of the International Community of Women Living With HIV/AIDS in Namibia, which aims to improve support, information and services available for HIV-positive women in the country. The group also works to increase HIV-positive women's influence and input on policy development in Namibia. According to the Star, stigma associated with HIV/AIDS and the "social realities of being a woman in a poverty-stricken and unequal society" underscore the fact that the "plight of an HIV-positive woman goes beyond already troubling issues of medication access and proper health care."
Jennifer Gatsi-Mallet, ICW Namibia's program coordinator, said that through the program, women and girls living with HIV/AIDS are allowed to "advocate for their own issues, be it rights issues, economic empowerment issues or sexual reproductive health issues." Gatsi-Mallet added, "Through support groups that they organize, meetings that they attend with ministry officials and training workshops that they attend, it's all in an effort to ultimately make them feel empowered, where at many times in their life they may feel powerless."
In 2005, ICW Namibia, under Gatsi-Mallet's leadership, began organizing training workshops in reaction to the growing problems experienced by HIV-positive women in previously isolated villages and communities, as well as the realization that women across the country had little or no access to health care facilities or reproductive and sexual health knowledge. At such a workshop in January, several HIV-positive women said they had been forcibly sterilized because of their HIV status. Although a few women knew the consequences of the procedure, they consented because they needed other services. Such cases have prompted ICW -- along with the Legal Assistance Centre in Namibia and ICW branches in London and Washington, D.C. -- to investigate the matter and support the affected women (Sidhu, Toronto Star, 8/20).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Jennifer Gatsi-Mallet, ICW Namibia's program coordinator, said that through the program, women and girls living with HIV/AIDS are allowed to "advocate for their own issues, be it rights issues, economic empowerment issues or sexual reproductive health issues." Gatsi-Mallet added, "Through support groups that they organize, meetings that they attend with ministry officials and training workshops that they attend, it's all in an effort to ultimately make them feel empowered, where at many times in their life they may feel powerless."
In 2005, ICW Namibia, under Gatsi-Mallet's leadership, began organizing training workshops in reaction to the growing problems experienced by HIV-positive women in previously isolated villages and communities, as well as the realization that women across the country had little or no access to health care facilities or reproductive and sexual health knowledge. At such a workshop in January, several HIV-positive women said they had been forcibly sterilized because of their HIV status. Although a few women knew the consequences of the procedure, they consented because they needed other services. Such cases have prompted ICW -- along with the Legal Assistance Centre in Namibia and ICW branches in London and Washington, D.C. -- to investigate the matter and support the affected women (Sidhu, Toronto Star, 8/20).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 15 марта 2012 г.
Federal Judge To Rule On Request For Temporary Injunction Against Enforcing Missouri Abortion-Related Law
Planned Parenthood of Kansas and Mid-Missouri would have to end abortion services at clinics in Columbia and Kansas City if a new Missouri law (SB 370) is allowed to take effect Thursday, PPKM CEO Peter Brownlie testified at a federal court hearing Thursday, the Kansas City Star reports (Morris, Kansas City Star, 8/23).
The law will designate facilities performing second- or third-trimester abortions or more than five first-trimester abortions each month as "ambulatory surgical centers." Clinics designated as ambulatory surgical centers are subject to increased regulation from the state Department of Health and Senior Services. The law will require that hallways be at least six feet wide and doors at least 44 inches wide. The clinics must also have separate male and female changing rooms for staff and a recovery room with space for a minimum of four beds with three feet of clearance around each bed. The health department said the law requires that three clinics in the state be licensed as ambulatory surgical centers.
PPKM on Monday filed a lawsuit that asks a federal court to block enforcement of the law. The suit alleges that the new regulations are unnecessary and are not meant to improve safety, but to interfere with a woman's constitutional right to abortion. PPKM in the suit also is asking that its Columbia and Kansas City clinics be exempt from the law because they were open before the law was passed (Kaiser Daily Women's Health Policy Report, 8/21). Brownlie on Thursday said the high costs of upgrading the clinics to comply with the law would force them to stop providing abortion services (Kansas City Star, 8/23). U.S. District Judge Ortrie Smith said he would rule on the request for a temporary injunction by Monday (Stafford, AP/Forbes, 8/23).
Smith noted quotes from elected officials and press releases about the law, adding, "Let's be real. The purpose of the legislation was to make abortions more difficult for women to obtain." State Assistant Attorney General Michael Pritchett replied, "This legislation was written to improve the standards for women who are seeking abortions." According to the Star, lawyers representing the state said the new regulations would not place a burden on women seeking abortion because abortions services are available in neighboring states (Kansas City Star, 8/23).
The law will designate facilities performing second- or third-trimester abortions or more than five first-trimester abortions each month as "ambulatory surgical centers." Clinics designated as ambulatory surgical centers are subject to increased regulation from the state Department of Health and Senior Services. The law will require that hallways be at least six feet wide and doors at least 44 inches wide. The clinics must also have separate male and female changing rooms for staff and a recovery room with space for a minimum of four beds with three feet of clearance around each bed. The health department said the law requires that three clinics in the state be licensed as ambulatory surgical centers.
PPKM on Monday filed a lawsuit that asks a federal court to block enforcement of the law. The suit alleges that the new regulations are unnecessary and are not meant to improve safety, but to interfere with a woman's constitutional right to abortion. PPKM in the suit also is asking that its Columbia and Kansas City clinics be exempt from the law because they were open before the law was passed (Kaiser Daily Women's Health Policy Report, 8/21). Brownlie on Thursday said the high costs of upgrading the clinics to comply with the law would force them to stop providing abortion services (Kansas City Star, 8/23). U.S. District Judge Ortrie Smith said he would rule on the request for a temporary injunction by Monday (Stafford, AP/Forbes, 8/23).
Smith noted quotes from elected officials and press releases about the law, adding, "Let's be real. The purpose of the legislation was to make abortions more difficult for women to obtain." State Assistant Attorney General Michael Pritchett replied, "This legislation was written to improve the standards for women who are seeking abortions." According to the Star, lawyers representing the state said the new regulations would not place a burden on women seeking abortion because abortions services are available in neighboring states (Kansas City Star, 8/23).
Missouri Health Director Hires Private Lawyers To Prosecute Case
Missouri Health Director Jane Drummond on Wednesday in a letter to state Attorney General Jay Nixon (D) said she would be using a private law firm rather than the attorney general's office to defend PPKM's challenge to the law, the St. Louis Post-Dispatch reports. Drummond has hired two lawyers from the Kansas City-based conservative religious group Alliance Defense Fund to defend the case. The lawyers, Dale Schowengerdt and Kevin Theriot, are not charging the state for their work (St. Louis Post-Dispatch, 8/23).
Drummond in the letter to Nixon said that she is using separate counsel because Nixon has "been an outspoken supporter of abortion on demand and a political ally of Planned Parenthood." She also wrote, "I did not believe I could trust you to defend me and my department vigorously" (Lieb, AP/Springfield News-Leader, 8/23). The Missouri Republican Party on Tuesday said that Nixon, who is running against Gov. Matt Blunt (R) in the 2008 gubernatorial race, had a conflict of interest in the case, citing the attorney general's decision in the 1990s to allow state funds to be used to hire a private lawyer to defend a Missouri law against a challenge by Planned Parenthood. Scott Holste, a spokesperson for Nixon, said the case is "about law, not politics."
Schowengerdt said he and Theriot "have every intention to work with the attorney general and defend this law together" (St. Louis Post-Dispatch, 8/23). Pritchett on Thursday said Nixon believes his office should lead the prosecution of the case. The attorneys for Drummond appeared at the hearing Thursday and presented testimony from Elizabeth Shadigian, an ob-gyn at the University of Michigan, about the risks of medical abortion drugs, the Star reports. According to the Star, PPKM's Kansas City clinic only provides drugs for medical abortions, while the Columbia clinic also provides first-trimester surgical abortions (Kansas City Star, 8/23).
"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.
четверг, 8 марта 2012 г.
Women Live Longer But In A Worse Condition
Catalan researchers have studied the socioeconomic and health inequalities experienced by people over the age of 64. The results of the study show that women live longer, but experience more limitations to daily activity (53%) and a lower quality of life than men of the same age (30%).
Although women have a longer life expectancy, they experience a much greater prevalence of disability in old age than men do. This is the main conclusion of the study published in the latest issue of the Journal of Women's Health.
"We focused on a socioeconomic position factor such as educational level and health factors such as limitations to daily activity. By studying this relationship we were able to see the social inequalities in dependency", Albert Espelt, lead author of the study and a researcher at the Public Health Agency of Barcelona, tells SINC.
The study is based on the health surveys that have been carried out in Barcelona by the Public Health Agency since 1982. "These are representative of the non-institutionalised population living in Barcelona", explains the expert. In total, the team interviewed 4,244 people aged above 64 (893 in 1992, 2,140 in 2000 and 1,211 in 2006).
"We saw differences in limitations according to socioeconomic position, which remained steady over the course of time", the expert points out.
The prevalence of disability in people aged over 64 increased among women in Catalonia between 1992 and 2006, but not among men, due to the increase in female life expectancy. The prevalence of disability in 2006 was 30% among men and 53% in women. In other words, it increases among the most elderly women.
"The double burden of work that women experience throughout their lives (domestic work and work outside the home) is a key factor in explaining this difference in different studies", says Espelt. Domestic work is less rewarding than working outside the home, and leads to a greater prevalence of non-fatal diseases such as musculoskeletal problems and depression.
Fewer inequalities with the Law of Dependency?
The Law to Promote Personal Autonomy and Care for Dependent People governs the basic conditions for ensuring equality in personal autonomy and care for dependent people.
"In this sense, the law approved in 2006 has represented a step forward in recognising a new universal right for citizens. Now it is to be hoped that this law will help to reduce the social inequalities that we found in our study", points out the researcher.
"It is still too soon to demonstrate the impact of the 2006 law", says Espelt. The Public Health Agency of Barcelona is already designing a new health survey for 2011, which will include the same questions as the previous one.
Source: Plataforma SINC
Although women have a longer life expectancy, they experience a much greater prevalence of disability in old age than men do. This is the main conclusion of the study published in the latest issue of the Journal of Women's Health.
"We focused on a socioeconomic position factor such as educational level and health factors such as limitations to daily activity. By studying this relationship we were able to see the social inequalities in dependency", Albert Espelt, lead author of the study and a researcher at the Public Health Agency of Barcelona, tells SINC.
The study is based on the health surveys that have been carried out in Barcelona by the Public Health Agency since 1982. "These are representative of the non-institutionalised population living in Barcelona", explains the expert. In total, the team interviewed 4,244 people aged above 64 (893 in 1992, 2,140 in 2000 and 1,211 in 2006).
"We saw differences in limitations according to socioeconomic position, which remained steady over the course of time", the expert points out.
The prevalence of disability in people aged over 64 increased among women in Catalonia between 1992 and 2006, but not among men, due to the increase in female life expectancy. The prevalence of disability in 2006 was 30% among men and 53% in women. In other words, it increases among the most elderly women.
"The double burden of work that women experience throughout their lives (domestic work and work outside the home) is a key factor in explaining this difference in different studies", says Espelt. Domestic work is less rewarding than working outside the home, and leads to a greater prevalence of non-fatal diseases such as musculoskeletal problems and depression.
Fewer inequalities with the Law of Dependency?
The Law to Promote Personal Autonomy and Care for Dependent People governs the basic conditions for ensuring equality in personal autonomy and care for dependent people.
"In this sense, the law approved in 2006 has represented a step forward in recognising a new universal right for citizens. Now it is to be hoped that this law will help to reduce the social inequalities that we found in our study", points out the researcher.
"It is still too soon to demonstrate the impact of the 2006 law", says Espelt. The Public Health Agency of Barcelona is already designing a new health survey for 2011, which will include the same questions as the previous one.
Source: Plataforma SINC
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