Senator Hillary Rodham Clinton (D-NY) on Tuesday said the House-approved fiscal year 2006 spending-cut package (S 1932) could increase the number of unplanned pregnancies because it would allow states to discontinue Medicaid coverage of contraception and family planning services, Long Island Newsday reports (Thrush, Long Island Newsday, 12/21). The House on Monday voted 212-206 to approve the $39.7 billion in spending cuts, including $6.4 billion in net savings from Medicare and about $4.8 billion in net savings from Medicaid over five years. States also would be permitted to scale back or eliminate services that currently are guaranteed under federal law (Kaiser Daily Health Policy Report, 12/20). Under current federal Medicaid rules, states are required to offer family planning services (Barrett, AP/Long Island Newsday, 12/20). However, states could "scuttle" those services under the new measure, according to Newsday. "I think this bill may very well increase the number of unintended pregnancies and abortions in our country," Rodham Clinton said (Long Island Newsday, 12/21). She added, "We obviously have very strong opinions and deeply held convictions about abortion, but are we also divided about contraception and family planning? Are we not in this body committed to reducing the number of abortions? Apparently we're not" (AP/Long Island Newsday, 12/20). Republican congressional leaders say the bill aims to give states more flexibility in administering their Medicaid programs, and some experts say states are unlikely to halt family planning and contraception coverage, in part because the federal government pays for 90% of the costs, Newsday reports (Long Island Newsday, 12/21). According to an unnamed staff member for a Senate Republican, state Medicaid plans under the measure would still have to remain equivalent to plans such as the Federal Employees Health Benefits Program or state employee insurance plans, most of which cover family planning services and contraception, CQ HealthBeat reports. The Senate is expected to vote on the bill on Wednesday (Carey, CQ HealthBeat, 12/20).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
воскресенье, 26 февраля 2012 г.
воскресенье, 19 февраля 2012 г.
Breastfeeding Study Of HIV-Infected Women In Low-Resource Settings: Early Cessation Or Continued Breastfeeding?
A new study by researchers from Columbia University's Mailman School of Public Health addresses one of the most challenging issues in infant health and preventing mother-to-child HIV transmission in poor countries. In these settings, HIV-infected mothers had been advised that for the best outcome for their infants, they should exclusively breast-feed, followed by a rapid weaning four to six months after birth. But according to the study conducted in Lusaka, Zambia by Mailman School researchers, which was published in the July 10 issue of the New England Journal of Medicine, abrupt cessation of breast-feeding by HIV+ mothers after the first four months of life did not result in any statistically significant benefit to infants in terms of HIV-free survival at 24 months, compared to those infants who were weaned at an average of 16 months of age (68.4% versus 64%). A further finding from the study indicated that infants who were HIV+ at four months of age had significantly higher death rates by 24 months if they were abruptly weaned than if breast-feeding were continued (74% versus 55%).
Among infants who were breast- fed and not infected with HIV at four months, there was no statistically significant difference in HIV-free survival at 24 months - 84 percent for those who stopped breast- feeding early compared to 81 percent who continued to breast- feed.
The study included 958 women with HIV and their infants. The proportion of new HIV infections between four and 24 months was not significantly different between the children whose mother abruptly stopped breast-feeding and those whose mothers continued to breast-feed indefinitely, and no significant differences were found in survival between them. Seventy-six percent of infants whose mothers stopped breast-feeding at four months survived to 24 months of age versus 75 percent of infants whose mothers continued breast- feeding for as long as the women chose. Four months was selected as the weaning time because this was the minimum duration of exclusive breast-feeding that was recommended at the time the study was designed.
"We certainly did not anticipate that children who were already infected with HIV before weaning would have significantly worse outcomes if they were to forego breast milk, especially since, theoretically, formula and weaning cereal are nutritionally replete," said Louise Kuhn, PhD, associate professor of Epidemiology at the Mailman School of Public Health and in the Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University. "Our observation of a clear benefit of breast- feeding for HIV-infected children highlights the importance of strengthening infant diagnostic services to triage infected children into HIV care and treatment and to provide encouragement for continued breast-feeding of infected children."
Prior to this latest research it was believed that in many poor countries, mothers with HIV face a stark choice - to nurse their infants, and risk passing on HIV through their breast milk - or to formula feed, and deprive their infants of much of the natural immunity needed to protect against fatal diseases of early infancy. "In the developed world, mothers with HIV forego breast-feeding and formula feed their infants," said Lynne Mofenson, MD, chief of NIH's National Institute of Child Health and Human Development's Pediatric, Adolescent and Maternal AIDS Branch (NICHD), which provided support for the study. "But in many poor countries, there are barriers to formula feeding. Sanitation is lacking, clean water to mix formula is often not available, and many families have difficulty affording infant formula." Formula fed infants also miss out on protective antibodies - passed on through breast milk - needed to ward off the deadly infant diseases prevalent in many parts of the world. Formula feeding, also, may carry a social stigma for mothers and is often seen as acknowledgement that a woman has HIV.
With these latest findings, the researchers theorize that the chances of transmitting the virus may actually increase as a result of the weaning process. The breast swelling and infection (mastitis) that occurs when breast-feeding is sharply reduced may increase the likelihood that the virus will be transmitted in the few feedings that remain. "These results suggest that early, abrupt cessation of breast-feeding for HIV-infected women in low-resource settings should be avoided," Dr. Kuhn noted.
The National Institutes of Health (NIH) provided support for the study with additional funding by the Centers for Disease Control and Prevention and the United States Agency for International Development. NIH is now sponsoring additional studies to determine the most effective treatments to prevent the spread of HIV through breast milk.
About the Mailman School of Public Health
The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 1000 graduate students in pursuit of masters and doctoral degrees. Its students and more than 300 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. mailmanlumbia.edu/
Source: Stephanie Berger
Columbia University's Mailman School of Public Health
Among infants who were breast- fed and not infected with HIV at four months, there was no statistically significant difference in HIV-free survival at 24 months - 84 percent for those who stopped breast- feeding early compared to 81 percent who continued to breast- feed.
The study included 958 women with HIV and their infants. The proportion of new HIV infections between four and 24 months was not significantly different between the children whose mother abruptly stopped breast-feeding and those whose mothers continued to breast-feed indefinitely, and no significant differences were found in survival between them. Seventy-six percent of infants whose mothers stopped breast-feeding at four months survived to 24 months of age versus 75 percent of infants whose mothers continued breast- feeding for as long as the women chose. Four months was selected as the weaning time because this was the minimum duration of exclusive breast-feeding that was recommended at the time the study was designed.
"We certainly did not anticipate that children who were already infected with HIV before weaning would have significantly worse outcomes if they were to forego breast milk, especially since, theoretically, formula and weaning cereal are nutritionally replete," said Louise Kuhn, PhD, associate professor of Epidemiology at the Mailman School of Public Health and in the Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University. "Our observation of a clear benefit of breast- feeding for HIV-infected children highlights the importance of strengthening infant diagnostic services to triage infected children into HIV care and treatment and to provide encouragement for continued breast-feeding of infected children."
Prior to this latest research it was believed that in many poor countries, mothers with HIV face a stark choice - to nurse their infants, and risk passing on HIV through their breast milk - or to formula feed, and deprive their infants of much of the natural immunity needed to protect against fatal diseases of early infancy. "In the developed world, mothers with HIV forego breast-feeding and formula feed their infants," said Lynne Mofenson, MD, chief of NIH's National Institute of Child Health and Human Development's Pediatric, Adolescent and Maternal AIDS Branch (NICHD), which provided support for the study. "But in many poor countries, there are barriers to formula feeding. Sanitation is lacking, clean water to mix formula is often not available, and many families have difficulty affording infant formula." Formula fed infants also miss out on protective antibodies - passed on through breast milk - needed to ward off the deadly infant diseases prevalent in many parts of the world. Formula feeding, also, may carry a social stigma for mothers and is often seen as acknowledgement that a woman has HIV.
With these latest findings, the researchers theorize that the chances of transmitting the virus may actually increase as a result of the weaning process. The breast swelling and infection (mastitis) that occurs when breast-feeding is sharply reduced may increase the likelihood that the virus will be transmitted in the few feedings that remain. "These results suggest that early, abrupt cessation of breast-feeding for HIV-infected women in low-resource settings should be avoided," Dr. Kuhn noted.
The National Institutes of Health (NIH) provided support for the study with additional funding by the Centers for Disease Control and Prevention and the United States Agency for International Development. NIH is now sponsoring additional studies to determine the most effective treatments to prevent the spread of HIV through breast milk.
About the Mailman School of Public Health
The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 1000 graduate students in pursuit of masters and doctoral degrees. Its students and more than 300 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. mailmanlumbia.edu/
Source: Stephanie Berger
Columbia University's Mailman School of Public Health
воскресенье, 12 февраля 2012 г.
Raloxifene Reduces Breast Cancer Risk In Postmenopausal Women At All Risk Levels
Raloxifene protects postmenopausal women from developing invasive breast cancer whether they are at high or low risk of developing the disease, according to a new study.
The study, published in the September 1 issue of Clinical Cancer Research, also revealed that the drug appears to reduce risk in women with a family history of breast cancer down to a similar level to women without affected relatives.
Compared with a placebo drug, the study found that use of raloxifene was associated with a 58 percent reduction in breast cancer risk in women without a family history of the disease, and an 89 percent reduction in risk for women with a family history of breast cancer.
But the researchers say they cannot explain why protection seems greatest in women who may be genetically predisposed to develop the disease.
"We don't know what to make of this observation," said Marc E. Lippman, M.D., professor in the Department of Internal Medicine at the University of Michigan and the study's lead author. "It could be due to chance, or there may be other factors at work that we don't know about."
"But our bottom-line analysis as to why raloxifene universally reduces the risk of developing invasive cancer in women without a family history is that it interferes with the duration and concentration of estrogen, which acts as a tumor promoter in the majority of breast cancers," said Dr. Lippman.
The research team conducted a new analysis of the first large study of raloxifene, which tested the ability of the drug to prevent vertebral fractures in 7,705 postmenopausal women diagnosed with osteoporosis. The secondary endpoint of this multi-center, double-blind trial, known as MORE (Multiple Outcomes of Raloxifene Evaluation) was the drug's effect on breast cancer development; results, announced in 1999, demonstrated a 72 percent reduction in invasive breast cancer incidence after four years of raloxifene treatment, compared to use of a placebo.
The MORE trial was then extended four years to further evaluate the effect of raloxifene on breast cancer incidence in 4,011 of the original participants. Results of this trial, known as CORE (Continuing Outcomes Relevant to Evista), showed that eight years of raloxifene treatment was associated with a 66 percent decrease in invasive breast cancer incidence.
The current study was undertaken to assess the effect of raloxifene on level of breast cancer risk (higher versus lower) using data from both MORE and CORE.
Women at higher risk for breast cancer are generally older and have a greater lifetime exposure to estrogen, and the researchers found that this association held true in the reanalysis. But they also found that raloxifene reduced breast cancer risk in both women at lower and those at higher breast cancer risk, except for those women who had measurably low levels of estradiol, the major estrogen hormone in humans.
"In each variable commonly associated with a higher risk for developing breast cancer − age older than 65, age at menopause, a body mass index greater than 25, higher estradiol levels, prior use of estrogen replacement and a family history of breast cancer − use of raloxifene reduced incidence of breast cancer when compared to a placebo drug," Dr. Lippman said. "But it also reduced incidence in each of those variables that should have lowered risk, such as younger age, later menopause, etc., compared to use of a placebo drug."
"We don't define the lowest limit of risk, the point at which toxicity associated with use of raloxifene outweighs the benefits," he said.
Dr. Lippman stressed that he cannot comment on how raloxifene in this study measures up to tamoxifen use in general. He explains that although these findings come on the heels of the June publication of the 19,747-participant STAR trial, which evaluated tamoxifen against raloxifene in reducing breast cancer risk, no comparison can be made between the MORE, CORE and STAR clinical trials.
"These studies looked at two different groups of women," Dr. Lippman said. "Women enrolled in STAR were at high risk for developing breast cancer, so presumably, they had higher levels of estrogen in general. Women who participated in MORE and CORE were older and had osteoporoses and it is assumed that these women generally have lower levels of estrogen, because that is a risk factor for development of the disorder."
Raloxifene, also known by the trade name Evista, has not been approved by the federal Food and Drug Administration as an agent to prevent breast cancer development.
Co-authors of the study include investigators from the University of Pittsburgh, the Angeles Clinic and Research Institute, California Pacific Medical Center Research Institute, and Eli Lilly & Company, which manufactures raloxifene.
American Association for Cancer Research
aacr
View drug information on Estradiol Transdermal System; Evista.
The study, published in the September 1 issue of Clinical Cancer Research, also revealed that the drug appears to reduce risk in women with a family history of breast cancer down to a similar level to women without affected relatives.
Compared with a placebo drug, the study found that use of raloxifene was associated with a 58 percent reduction in breast cancer risk in women without a family history of the disease, and an 89 percent reduction in risk for women with a family history of breast cancer.
But the researchers say they cannot explain why protection seems greatest in women who may be genetically predisposed to develop the disease.
"We don't know what to make of this observation," said Marc E. Lippman, M.D., professor in the Department of Internal Medicine at the University of Michigan and the study's lead author. "It could be due to chance, or there may be other factors at work that we don't know about."
"But our bottom-line analysis as to why raloxifene universally reduces the risk of developing invasive cancer in women without a family history is that it interferes with the duration and concentration of estrogen, which acts as a tumor promoter in the majority of breast cancers," said Dr. Lippman.
The research team conducted a new analysis of the first large study of raloxifene, which tested the ability of the drug to prevent vertebral fractures in 7,705 postmenopausal women diagnosed with osteoporosis. The secondary endpoint of this multi-center, double-blind trial, known as MORE (Multiple Outcomes of Raloxifene Evaluation) was the drug's effect on breast cancer development; results, announced in 1999, demonstrated a 72 percent reduction in invasive breast cancer incidence after four years of raloxifene treatment, compared to use of a placebo.
The MORE trial was then extended four years to further evaluate the effect of raloxifene on breast cancer incidence in 4,011 of the original participants. Results of this trial, known as CORE (Continuing Outcomes Relevant to Evista), showed that eight years of raloxifene treatment was associated with a 66 percent decrease in invasive breast cancer incidence.
The current study was undertaken to assess the effect of raloxifene on level of breast cancer risk (higher versus lower) using data from both MORE and CORE.
Women at higher risk for breast cancer are generally older and have a greater lifetime exposure to estrogen, and the researchers found that this association held true in the reanalysis. But they also found that raloxifene reduced breast cancer risk in both women at lower and those at higher breast cancer risk, except for those women who had measurably low levels of estradiol, the major estrogen hormone in humans.
"In each variable commonly associated with a higher risk for developing breast cancer − age older than 65, age at menopause, a body mass index greater than 25, higher estradiol levels, prior use of estrogen replacement and a family history of breast cancer − use of raloxifene reduced incidence of breast cancer when compared to a placebo drug," Dr. Lippman said. "But it also reduced incidence in each of those variables that should have lowered risk, such as younger age, later menopause, etc., compared to use of a placebo drug."
"We don't define the lowest limit of risk, the point at which toxicity associated with use of raloxifene outweighs the benefits," he said.
Dr. Lippman stressed that he cannot comment on how raloxifene in this study measures up to tamoxifen use in general. He explains that although these findings come on the heels of the June publication of the 19,747-participant STAR trial, which evaluated tamoxifen against raloxifene in reducing breast cancer risk, no comparison can be made between the MORE, CORE and STAR clinical trials.
"These studies looked at two different groups of women," Dr. Lippman said. "Women enrolled in STAR were at high risk for developing breast cancer, so presumably, they had higher levels of estrogen in general. Women who participated in MORE and CORE were older and had osteoporoses and it is assumed that these women generally have lower levels of estrogen, because that is a risk factor for development of the disorder."
Raloxifene, also known by the trade name Evista, has not been approved by the federal Food and Drug Administration as an agent to prevent breast cancer development.
Co-authors of the study include investigators from the University of Pittsburgh, the Angeles Clinic and Research Institute, California Pacific Medical Center Research Institute, and Eli Lilly & Company, which manufactures raloxifene.
American Association for Cancer Research
aacr
View drug information on Estradiol Transdermal System; Evista.
воскресенье, 5 февраля 2012 г.
Antares Pharma And Population Council Announce Positive Phase 2 Trial Results
Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.
This first of its kind contraceptive gel may offer an attractive option for women. The combination of Nestorone, a highly potent and versatile synthetic progestin, and the natural estrogen estradiol, was chosen due to the potential for superior safety profiles when compared to other commonly used hormones in contraceptives. The ATD system is currently utilized in Elestrin® a marketed product for hormone replacement therapy (HRT) in postmenopausal women. The gel is easy to apply, crystal clear, fast drying and cosmetically appealing.
The trial was a dose-finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel on ovulation suppression in normal women of fertile age. Eighteen women participated in the trial, which took place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile. Each woman completing the study received each of the three separate doses of the gel for 21 days, separated by a washout month in which no products were administered when they recovered normal ovulation. The primary objective of the study was to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives included determining the plasma profile of estradiol and the evaluation of bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, was also assessed.
Active treatment concluded in October 2009. Safety and efficacy objectives were met and no serious adverse events or instances of skin irritation were recorded.
R?©gine Sitruk-Ware, executive director for research and development in the Reproductive Health program of the Population Council, said, "We have demonstrated that the transdermal gel combining Nestorone and estradiol is able to suppress ovulation at all doses tested and we determined the dose that gave the most stable levels of hormones to the subjects. Most women who participated in the study found the gel very easy to use and convenient. We believe this new formulation is likely to be a safe and effective contraceptive that offers a new option for women who may be unable to use alternative forms of contraception."
"The advantage of using transdermal delivery has been seen with HRT products where recent studies have shown a reduced side effects profile when compared to orally administered products. The ATD system offers a patient friendly, fast drying and cosmetically appealing gel product which can be easily applied daily. This product may offer an excellent opportunity to provide the most safe and effective contraception through an innovative drug delivery system in a large and growing global market segment," said Dario N. Carrara Ph.D., Antares Senior Vice President and Managing Director and the inventor of the ATD system.
The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. According to Business Insights (2007) the contraceptive market is projected to reach $7.5 billion by 2011.
Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council's patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management.
Source
Antares Pharma
Population Council
View drug information on Elestrin; Estradiol Transdermal System.
This first of its kind contraceptive gel may offer an attractive option for women. The combination of Nestorone, a highly potent and versatile synthetic progestin, and the natural estrogen estradiol, was chosen due to the potential for superior safety profiles when compared to other commonly used hormones in contraceptives. The ATD system is currently utilized in Elestrin® a marketed product for hormone replacement therapy (HRT) in postmenopausal women. The gel is easy to apply, crystal clear, fast drying and cosmetically appealing.
The trial was a dose-finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel on ovulation suppression in normal women of fertile age. Eighteen women participated in the trial, which took place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile. Each woman completing the study received each of the three separate doses of the gel for 21 days, separated by a washout month in which no products were administered when they recovered normal ovulation. The primary objective of the study was to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives included determining the plasma profile of estradiol and the evaluation of bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, was also assessed.
Active treatment concluded in October 2009. Safety and efficacy objectives were met and no serious adverse events or instances of skin irritation were recorded.
R?©gine Sitruk-Ware, executive director for research and development in the Reproductive Health program of the Population Council, said, "We have demonstrated that the transdermal gel combining Nestorone and estradiol is able to suppress ovulation at all doses tested and we determined the dose that gave the most stable levels of hormones to the subjects. Most women who participated in the study found the gel very easy to use and convenient. We believe this new formulation is likely to be a safe and effective contraceptive that offers a new option for women who may be unable to use alternative forms of contraception."
"The advantage of using transdermal delivery has been seen with HRT products where recent studies have shown a reduced side effects profile when compared to orally administered products. The ATD system offers a patient friendly, fast drying and cosmetically appealing gel product which can be easily applied daily. This product may offer an excellent opportunity to provide the most safe and effective contraception through an innovative drug delivery system in a large and growing global market segment," said Dario N. Carrara Ph.D., Antares Senior Vice President and Managing Director and the inventor of the ATD system.
The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. According to Business Insights (2007) the contraceptive market is projected to reach $7.5 billion by 2011.
Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council's patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management.
Source
Antares Pharma
Population Council
View drug information on Elestrin; Estradiol Transdermal System.
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