Neurocrine Biosciences,
Inc. (Nasdaq: NBIX) today announced positive results of its 'proof of
concept', safety, efficacy and dose-finding Phase II clinical trial using
its proprietary, orally-active small molecule Gonadotropin-Releasing
Hormone (GnRH) receptor antagonist (NBI-56418).
The 3-month data comes from a multi-center, randomized, double-blind,
placebo-controlled trial involving patients with a confirmed diagnosis of
endometriosis. The study followed a parallel-group design in which 76
subjects were randomized to one of three treatment groups: placebo, 75 mg
of NBI-56418, or 150 mg of NBI-56418 each administered once daily. Dosing
started on Day 2 to Day 7 of the menstrual cycle and continued over 12
weeks with assessments of symptoms and signs of disease conducted at 4-week
intervals using the Composite Pelvic Sign and Symptoms Score (CPSSS).
Assessment of pain intensity was measured daily by a Visual Analog Scale
(VAS) and collected by electronic diary. Full data regarding treatment
impact on menses, hormones and a variety of metabolic biomarkers will be
available at the completion of the ongoing 3-month safety follow-up period.
The primary endpoint of the study was reduction in the CPSSS, a
validated clinical endpoint assessing subjective and objective elements of
endometriosis. For the CPSSS, which has a maximum possible value of 15,
mean values at baseline were 9.1, 8.5 and 8.0 for the placebo, 75 mg and
150 mg groups respectively. After treatment, there were reductions of 3.7
(placebo), 3.9 (75 mg) and 5.0 (150 mg) points in the score at week 12.
A patient-completed VAS was used to record pain intensity on a daily
basis. Mean values for each 4-week interval were analyzed. This reveals
dose-related improvements of 5 (placebo), 14 (75 mg) and 21 (150 mg) from
baseline means of 31.2, 34.9 and 33.5 respectively. From a safety
perspective, preliminary information on the adverse event rates show that
there is little difference in the percentage of patients with an adverse
event across treatment groups. Treatment-related adverse events occurred in
39%; 36%; and 26% of the patients in the placebo, 75 mg and 150 mg groups
respectively. There was no increase in hot flashes in the NBI-56418 treated
groups compared with placebo.
"We are pleased with the results demonstrating a robust treatment
effect with NBI-56418 as shown by two clinical outcome measures. The
reductions in scores at the highest dose were at the levels expected for
peptide agonists such as Lupron Depot(R), which while efficacious, can lead
to numerous undesirable side effects and limit utility. While not fully
analyzed, preliminary results show that our GnRH antagonist demonstrated
reductions in pain scores at the earlier time points in the study," said
Chris O'Brien, M.D., Senior Vice President of Clinical Development for
Neurocrine Biosciences.
"We have met our 'proof of concept' criteria in the clinical setting
with our GnRH antagonist. Since the effects of estradiol reduction have
been previously well correlated with a reduction of pain and other symptoms
of endometriosis, we believe our oral GnRH antagonist will have significant
therapeutic application in endometriosis. These new data are encouraging
and suggest that sufficient estradiol suppression has been achieved for
pain reduction while potentially avoiding reduction in bone mineral density
and the other undesirable metabolic consequences of GnRH agonist
therapies," said Wendell Wierenga, Ph.D. Executive Vice President of
Research and Development for Neurocrine Biosciences.
"Based on these data, we are moving ahead to select the dosing regimen
for an expanded six-month study in patients with endometriosis. This Phase
IIb study will include several hundred patients and is expected to be
initiated in the 3rd Quarter of 2006," added Wierenga.
Additional Phase II Clinical Studies Underway with GnRH for
Endometriosis
Neurocrine is continuing to enroll patients in a second Phase II study
in patients with endometriosis that was initiated in December 2005 to
explore once vs. twice daily dosing. This study, a multi-dose,
double-blind, placebo-controlled trial, is enrolling 72 patients and is
designed to assess safety and efficacy over a three-month period. The
primary endpoint of reduction in endometriotic pain will be measured by the
CPSSS. Preliminary results are expected to be announced in the 4th Quarter
of 2006.
Neurocrine will be initiating a Phase IIb study in the 3rd quarter of
2006 in which patients with endometriosis will receive NBI-56418 for six
months. In addition to confirming the effect of NBI-56418 on endometriotic
pain, this study is designed to assess the impact of treatment on bone
mineral density. The six-month results, together with data from ongoing
Phase II studies will be the basis for securing agreement to a registration
plan acceptable to the FDA, estimated to occur next year. Finally, the
company recently started a Phase I study in male volunteers as part of the
Benign Prostate Hyperplasia development program. The Company expects to
provide more details on the six month trial together with ongoing results
from the Phase I trial in the 3rd Quarter of 2006.
Background
Nearly 7 million women in the US have endometriosis, many with severe
or moderate symptoms. Many patients are believed to be misdiagnosed or
undiagnosed. The impact of endometriosis on the lives of sufferers can be
significant -- adversely affecting the ability of patients to maintain
relationships and employment.
Surgery and medical treatments are currently available for women with
endometriosis. Surgery is not acceptable to many patients. Although
indicated for endometriosis, medical therapies such as the injectable GnRH
agonists leuprolide or injectable progesterone are associated with a range
of potentially unacceptable side effects including bone loss. Consequently,
prescribing physicians often reserve these medical interventions for
patients with severe endometriosis. For the majority of endometriosis
patients suffering from moderate or mild symptoms, the remaining treatment
options, oral contraceptives and analgesics, are only partially effective.
Based on the large number of endometriosis sufferers and the
significant level of unmet need, we believe a highly attractive commercial
opportunity exists for a new product that is able to offer patients and
prescribers effective control of endometriosis symptoms with limited side
effects.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical
Company focused on neurological and endocrine diseases and disorders. Our
product candidates address some of the largest pharmaceutical markets in
the world including insomnia, anxiety, depression, diabetes, irritable
bowel syndrome, and autoimmunity. Neurocrine Biosciences, Inc. news
releases are available through the Company's website via the Internet at
neurocrine
In addition to historical facts, this press release may contain
forward-looking statements that involve a number of risks and
uncertainties. Among the factors that could cause actual results to differ
materially from those indicated in the forward looking statements are risks
and uncertainties associated with Neurocrine's business and finances in
general including the risks and uncertainties associated with, or arising
out of, drug discovery, pre-clinical and clinical development of
pharmaceutical products. Specifically, the Company faces risks and
uncertainties arising out of it GnRH clinical development program including
risk that its lead candidate, NBI-56418, will not proceed to later stage
clinical trials; risk that should NBI-56418 may prove unsuitable for
continued development, the Company will not be successful in identifying
alternative GnRH antagonist products that are safe and effective; risk
relating to the Company's dependence on contract manufacturers for GnRH
antagonist product clinical drug supply and compliance with regulatory
requirements for marketing approval; risks that the Company may be
dependent on corporate collaborators for commercial manufacturing and
marketing and sales activities for its GnRH antagonist products;
uncertainties relating to patent protection for the Company's GnRH
antagonist products and intellectual property rights of third parties;
risks and uncertainties relating to competitive products and technological
changes that may limit demand for the Company's GnRH antagonist products;
risk that the Company will be unable to raise additional funding required
to complete development of its GnRH antagonist product candidates; and the
other risks described in the Company's report on Form 10-K for the year
ended December 31, 2005. Neurocrine undertakes no obligation to update the
statements contained in this press release after the date hereof.
Neurocrine Biosciences, Inc.
neurocrine
View drug information on Estradiol Transdermal System; Lupron Depot.
суббота, 15 октября 2011 г.
суббота, 8 октября 2011 г.
Latest WHO Handbook Presents Family Planning Options For Women Around The World
The recently released Family Planning: A Global Handbook for Providers includes a chapter on fertility-awareness based methods of family planning highlighting the Standard Days Method and the TwoDay Method, two family-planning methods developed by Georgetown University Medical Center's Institute for Reproductive Health, as effective, easy-to-use and without the health risks of chemically based family planning methods such as birth control pills.
The publication, developed by the World Health Organization, Johns Hopkins University, and the United States Agency for International Development, is used by family planning providers worldwide, especially in developing countries.
"With the inclusion of the Standard Days and TwoDay Methods in the WHO family planning handbook for providers, we anticipate that many more providers around the world will offer fertility awareness methods, thereby increasing women's access to these effective, easy-to-use, low-cost options," said Victoria Jennings, Ph.D., co-developer of the methods and director of the Institute for Reproductive Health. She is also professor of obstetrics and gynecology at Georgetown University Medical Center.
Utilizing data from sophisticated computer modeling of reproductive physiology and field studies, the Georgetown researchers developed the Standard Days Method and CycleBeads™, the simple visual aid used by women who follow the Standard Days Method. They enable a woman to identify the 12-day "fertile window" of her menstrual cycle. These 12 days take into account the life span of the woman's egg (about 24 hours) and the viable life of sperm (about 5 days) as well as the variation in the actual timing of ovulation. In a clinical trial, the Standard Days Method proved to be more than 95 percent effective with correct use, similar to other user-directed methods such as the pill. Because this natural method identifies all of the fertile days, it also helps couples who want a pregnancy to achieve their goal.
To use CycleBeads to follow the Standard Days Method, a woman moves a black rubber ring over a series of color-coded beads that represent her fertile and low fertility days. The day a woman starts her period she puts the rubber ring on CycleBeads' red bead. Each day she moves the ring one bead, always in the direction of the arrow. When the ring is on the red bead or a dark bead, there is very low likelihood of pregnancy. When the ring is on a glow-in-the-dark white bead - Days 8 through 19 - there is a high likelihood of getting pregnant. CycleBeads also helps a woman know if her cycle length is in the range (26-32 days long) for using this method effectively.
The TwoDay Method employs a very different approach to identifying the fertile days of a woman's menstrual cycle. TwoDay Method users monitor the presence or absence of cervical secretions. Women then use a simple formula to determine whether they should consider themselves fertile on a specific day. Georgetown studies have found this method to be 96 percent effective.
Additional information on the Standard Days Method and the TwoDay Method, including details for on-line training for healthcare providers, is available from the Institute for Reproductive Health at irh. In addition to being available from a growing number of reproductive health providers worldwide, CycleBeads can be purchased at retail outlets or over the internet at cyclebeads.
The WHO Global Family Planning Handbook can be found online at fphandbook. The Fertility Awareness Chapter (17) is located on pages 239-254.
About The Institute for Reproductive Health
The Institute for Reproductive Health is dedicated to helping women and men make informed choices about family planning and providing them with simple and effective natural options. As part of Georgetown University's School of Medicine, the Institute conducts research to develop natural methods of family planning and test them in service delivery settings. irh
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO).
gumc.georgetown.edu
The publication, developed by the World Health Organization, Johns Hopkins University, and the United States Agency for International Development, is used by family planning providers worldwide, especially in developing countries.
"With the inclusion of the Standard Days and TwoDay Methods in the WHO family planning handbook for providers, we anticipate that many more providers around the world will offer fertility awareness methods, thereby increasing women's access to these effective, easy-to-use, low-cost options," said Victoria Jennings, Ph.D., co-developer of the methods and director of the Institute for Reproductive Health. She is also professor of obstetrics and gynecology at Georgetown University Medical Center.
Utilizing data from sophisticated computer modeling of reproductive physiology and field studies, the Georgetown researchers developed the Standard Days Method and CycleBeads™, the simple visual aid used by women who follow the Standard Days Method. They enable a woman to identify the 12-day "fertile window" of her menstrual cycle. These 12 days take into account the life span of the woman's egg (about 24 hours) and the viable life of sperm (about 5 days) as well as the variation in the actual timing of ovulation. In a clinical trial, the Standard Days Method proved to be more than 95 percent effective with correct use, similar to other user-directed methods such as the pill. Because this natural method identifies all of the fertile days, it also helps couples who want a pregnancy to achieve their goal.
To use CycleBeads to follow the Standard Days Method, a woman moves a black rubber ring over a series of color-coded beads that represent her fertile and low fertility days. The day a woman starts her period she puts the rubber ring on CycleBeads' red bead. Each day she moves the ring one bead, always in the direction of the arrow. When the ring is on the red bead or a dark bead, there is very low likelihood of pregnancy. When the ring is on a glow-in-the-dark white bead - Days 8 through 19 - there is a high likelihood of getting pregnant. CycleBeads also helps a woman know if her cycle length is in the range (26-32 days long) for using this method effectively.
The TwoDay Method employs a very different approach to identifying the fertile days of a woman's menstrual cycle. TwoDay Method users monitor the presence or absence of cervical secretions. Women then use a simple formula to determine whether they should consider themselves fertile on a specific day. Georgetown studies have found this method to be 96 percent effective.
Additional information on the Standard Days Method and the TwoDay Method, including details for on-line training for healthcare providers, is available from the Institute for Reproductive Health at irh. In addition to being available from a growing number of reproductive health providers worldwide, CycleBeads can be purchased at retail outlets or over the internet at cyclebeads.
The WHO Global Family Planning Handbook can be found online at fphandbook. The Fertility Awareness Chapter (17) is located on pages 239-254.
About The Institute for Reproductive Health
The Institute for Reproductive Health is dedicated to helping women and men make informed choices about family planning and providing them with simple and effective natural options. As part of Georgetown University's School of Medicine, the Institute conducts research to develop natural methods of family planning and test them in service delivery settings. irh
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO).
gumc.georgetown.edu
суббота, 1 октября 2011 г.
2.5 Million Child Lives A Year Could Be Saved By Prioritizing Low-Cost, Simple Health Measures
Almost a third of the children under age five who die each year could be saved if governments rebalance health spending to ensure low-cost, simple interventions such as safe water and hygiene, bed nets and basic maternal and newborn care, leading aid agency World Vision said today. Currently, 8.8 million children a year die before age five, most of preventable causes.
A new report by the Christian humanitarian agency calls for scaling up simple preventive health measures for mothers and children, particularly at the community level. This must be a priority to make rapid progress against the top child killers of pneumonia, diarrhea and malaria, the international analysis shows. Citing interventions that can cost pennies, the study concludes that more strategic use of funding and resources would keep millions of children from dying before they reach their fifth birthdays.
"Our world is in the grip of a chronic humanitarian crisis with more than 24,000 children dying each day," said World Vision International's President Kevin Jenkins. "Yet we know that even in the poorest countries, most child deaths are not inevitable."
"The truth is politics, not poverty, is what is killing these children. For many politicians, saving infants and children from illness and death is simply not a priority. Our campaign will mobilize and equip people worldwide to hold their leaders to account for ensuring child health now," said Jenkins.
The report comes as World Vision launches Child Health Now, its first global advocacy campaign, for the 100 countries in which it works. The five-year initiative aims to help reduce child mortality by two-thirds by 2015 through ensuring government leaders deliver on their commitments to help meet this goal.*
"At least 2.5 million children's lives could be saved each year by implementing low-cost, simple interventions such as water and hygiene, bed nets, and basic maternal and newborn care," said World Vision's Jenkins. "As many as six million children could be saved yearly by combining these approaches with more strategic allocation of resources to meet needs at the community level, and by fulfilled global donor commitments."
In the U.S., government leaders have the opportunity to build on the country's global health funding leadership by appropriating the resources promised in last year's Global AIDS, TB and Malaria bill, and moving on to pass the newly introduced Global Child Survival Act of 2009, which calls for a clear, coordinated strategy to save the lives of newborns, infants and children in developing countries.
Recent history shows substantial progress is achievable: child deaths have been cut by more than half since 1960, when 20 million children died from preventable causes. Child mortality has decreased in all regions of the world because of increased access to interventions such as oral rehydration therapy and immunizations - and further progress can be made by expanding those approaches, emphasizing hand washing with soap and providing needed vitamins, among other basic steps
Report author Regina Keith, World Vision's senior health campaign adviser, said much health funding - both from donor nations and developing countries' budgets - is spent in ways that fail to have the greatest impact.
"Prevention is better, and cheaper, than treating children once they get ill," said Keith. "Yet an estimated 270 million children live in what amounts to a health care desert, lacking access to even the most basic provision, while millions more face patchy, low-quality systems they can't afford. If countries want to ensure the survival of their next generation, they must focus on providing low-cost, simple interventions to keep these young children healthy."
Source: Geraldine Ryerson-Cruz
World Vision
A new report by the Christian humanitarian agency calls for scaling up simple preventive health measures for mothers and children, particularly at the community level. This must be a priority to make rapid progress against the top child killers of pneumonia, diarrhea and malaria, the international analysis shows. Citing interventions that can cost pennies, the study concludes that more strategic use of funding and resources would keep millions of children from dying before they reach their fifth birthdays.
"Our world is in the grip of a chronic humanitarian crisis with more than 24,000 children dying each day," said World Vision International's President Kevin Jenkins. "Yet we know that even in the poorest countries, most child deaths are not inevitable."
"The truth is politics, not poverty, is what is killing these children. For many politicians, saving infants and children from illness and death is simply not a priority. Our campaign will mobilize and equip people worldwide to hold their leaders to account for ensuring child health now," said Jenkins.
The report comes as World Vision launches Child Health Now, its first global advocacy campaign, for the 100 countries in which it works. The five-year initiative aims to help reduce child mortality by two-thirds by 2015 through ensuring government leaders deliver on their commitments to help meet this goal.*
"At least 2.5 million children's lives could be saved each year by implementing low-cost, simple interventions such as water and hygiene, bed nets, and basic maternal and newborn care," said World Vision's Jenkins. "As many as six million children could be saved yearly by combining these approaches with more strategic allocation of resources to meet needs at the community level, and by fulfilled global donor commitments."
In the U.S., government leaders have the opportunity to build on the country's global health funding leadership by appropriating the resources promised in last year's Global AIDS, TB and Malaria bill, and moving on to pass the newly introduced Global Child Survival Act of 2009, which calls for a clear, coordinated strategy to save the lives of newborns, infants and children in developing countries.
Recent history shows substantial progress is achievable: child deaths have been cut by more than half since 1960, when 20 million children died from preventable causes. Child mortality has decreased in all regions of the world because of increased access to interventions such as oral rehydration therapy and immunizations - and further progress can be made by expanding those approaches, emphasizing hand washing with soap and providing needed vitamins, among other basic steps
Report author Regina Keith, World Vision's senior health campaign adviser, said much health funding - both from donor nations and developing countries' budgets - is spent in ways that fail to have the greatest impact.
"Prevention is better, and cheaper, than treating children once they get ill," said Keith. "Yet an estimated 270 million children live in what amounts to a health care desert, lacking access to even the most basic provision, while millions more face patchy, low-quality systems they can't afford. If countries want to ensure the survival of their next generation, they must focus on providing low-cost, simple interventions to keep these young children healthy."
Source: Geraldine Ryerson-Cruz
World Vision
суббота, 24 сентября 2011 г.
Obama To Re-Nominate Johnsen To Head DOJ Office Of Legal Counsel
President Obama plans to re-nominate Dawn Johnsen as his choice for the head of the Department of Justice's Office of Legal Counsel after the Senate failed to take action on her nomination last year, according to a White House official, CQ Today reports (Perine, CQ Today, 1/7). Some Senate Republicans have argued that Johnsen is too controversial for the post given her criticism of legal memorandums OLC issued during the Bush administration. She also has drawn fire for her earlier work in support of abortion rights (CQ Today, 1/7).
Johnsen, an Indiana University law professor who served as acting head of OLC during the Clinton administration, was approved by the Senate Judiciary Committee in March 2009. However, the full Senate never voted on her nomination, in part because of criticism from the GOP (Savage, New York Times, 1/8).
In the past, Democratic Sen. Ben Nelson (Neb.) and then-Republican Arlen Specter (Pa.) had expressed reservations, although they have not declared how they would vote (CQ Today). Republican Sen. Richard Lugar (Ind.) has said he will support Johnsen (New York Times, 1/8).
Democratic advocates praised the resubmission. Marge Baker, executive vice president of People for the American Way, said, "President Obama made an excellent choice in Professor Johnsen to lead OLC, and today he's shown his willingness to stand on principle and call the Republicans on their attack and delay tactics."
Obama also re-nominated Louis Butler and Edward Chen, two choices for U.S. district court judgeships (CQ Today, 1/7).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2009 The Advisory Board Company. All rights reserved.
суббота, 17 сентября 2011 г.
Philadelphia Inquirer Examines Developments, Ethics In Microbicide Research
The Philadelphia Inquirer on Monday examined issues surrounding microbicide research, including recent developments and ethical issues. The Inquirer reports that the use of microbicides to prevent the spread of HIV "seemed so simple" 15 years ago, when researchers thought they could provide a vaginal gel that would be applied prior to sex. The gel would be "cheap and nonprescription, provide contraception and prevent many sexually transmitted infections, not just HIV," the Inquirer reports, adding that women also would be able to control its use, making microbicides "popular in places where men did not like wearing condoms -- that is, everywhere."
However, "the field's record is so disappointing that anything short of failure is cause for cheers," the Inquirer reports. More than $1 billion has been spent on research and development goals worldwide, with tens of thousands of women participating in clinical trials for potential microbicides that include things like lime juice, a seaweed extract and grain alcohol. The most recent development occurred in February when the International Partnership for Microbicides announced that an experimental gel -- PRO 2000 -- for the first time "had shown a hint more protection" against the virus than a placebo, according to the Inquirer. The trial -- which was conducted by researchers in Africa and Philadelphia -- was called "an important milestone," and Lisa Maslankowski, a researcher at the University of Pittsburgh who participated in the study, said that the PRO 2000 study was "the first time we've seen any signal of effectiveness, so this is very exciting for the field."
However, the results were statistically insignificant and indicated the gel's success "could have been a fluke," according to the Inquirer. The results from an ongoing trial of low-dose PRO 2000 are expected in late 2009. It would be considered statistically significant if the results showed a 33% decrease in HIV incidence, "a smidgen more than in the Philadelphia-Africa study," which could "pose another quandary," the Inquirer reports. Rowena Johnston, vice president of research at amFAR, said, "If we put out a marginally effective product, we know people would reduce their condom use. Then HIV infection would increase instead of decrease."
Advocates for microbicides are "undaunted," and there is a "new hope" that antiretroviral drugs could be used to prevent transmission of the virus. Still, "no one believes it will be simple," and many experts say the "science behind many studies was weak, the ethical quandaries were underestimated, and the basic rule of product development -- find out what the consumer wants -- was ignored," the Inquirer reports. In addition, microbicide research is "full of ethical and real-world dilemmas," including the fact that "developers cannot knowingly increase HIV risk while seeking a way to reduce it," the Inquirer reports. Women therefore are provided with condoms and "strenuously counseled to persuade their partners to wear them," but for some women in low-income countries their "only leverage may be the nominal payment" they are given for participating in the study. Anna Forbes, deputy director of the Global Campaign for Microbicides, said that women "can sometimes get their partners to use condoms during the trial because they are making money" but that condom use ends after the trial is over. Forbes said it is a "gray area ethically."
The failures of previous studies have led researchers to "now realize they need to come up with products that are not just good for women, but that women feel good using," the Inquirer reports, adding that once-daily formulations and slow-release vaginal rings are "in the works." Sharon Hillier, head of the federal Microbicide Trials Network and a researcher at the University of Pittsburgh, said the past decade "showed us there's no magic bullet." She also said that successes in preventing mother-to-child transmission through antiretrovirals have led researchers to explore pre-exposure prophylaxis. The Inquirer reports that this is a "radical shift," as the drugs are "neither cheap nor nonprescription" and come with "the danger of unintended consequences." Forbes said, "In poor countries, what are the odds that prevention pills would be taken from a woman and given to a family member with HIV?" In addition, there is a concern that expanded use of antiretrovirals could lead to drug resistance, "undermining treatment as well as prevention," the Inquirer reports (McCullough, Philadelphia Inquirer, 3/23).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
However, "the field's record is so disappointing that anything short of failure is cause for cheers," the Inquirer reports. More than $1 billion has been spent on research and development goals worldwide, with tens of thousands of women participating in clinical trials for potential microbicides that include things like lime juice, a seaweed extract and grain alcohol. The most recent development occurred in February when the International Partnership for Microbicides announced that an experimental gel -- PRO 2000 -- for the first time "had shown a hint more protection" against the virus than a placebo, according to the Inquirer. The trial -- which was conducted by researchers in Africa and Philadelphia -- was called "an important milestone," and Lisa Maslankowski, a researcher at the University of Pittsburgh who participated in the study, said that the PRO 2000 study was "the first time we've seen any signal of effectiveness, so this is very exciting for the field."
However, the results were statistically insignificant and indicated the gel's success "could have been a fluke," according to the Inquirer. The results from an ongoing trial of low-dose PRO 2000 are expected in late 2009. It would be considered statistically significant if the results showed a 33% decrease in HIV incidence, "a smidgen more than in the Philadelphia-Africa study," which could "pose another quandary," the Inquirer reports. Rowena Johnston, vice president of research at amFAR, said, "If we put out a marginally effective product, we know people would reduce their condom use. Then HIV infection would increase instead of decrease."
Advocates for microbicides are "undaunted," and there is a "new hope" that antiretroviral drugs could be used to prevent transmission of the virus. Still, "no one believes it will be simple," and many experts say the "science behind many studies was weak, the ethical quandaries were underestimated, and the basic rule of product development -- find out what the consumer wants -- was ignored," the Inquirer reports. In addition, microbicide research is "full of ethical and real-world dilemmas," including the fact that "developers cannot knowingly increase HIV risk while seeking a way to reduce it," the Inquirer reports. Women therefore are provided with condoms and "strenuously counseled to persuade their partners to wear them," but for some women in low-income countries their "only leverage may be the nominal payment" they are given for participating in the study. Anna Forbes, deputy director of the Global Campaign for Microbicides, said that women "can sometimes get their partners to use condoms during the trial because they are making money" but that condom use ends after the trial is over. Forbes said it is a "gray area ethically."
The failures of previous studies have led researchers to "now realize they need to come up with products that are not just good for women, but that women feel good using," the Inquirer reports, adding that once-daily formulations and slow-release vaginal rings are "in the works." Sharon Hillier, head of the federal Microbicide Trials Network and a researcher at the University of Pittsburgh, said the past decade "showed us there's no magic bullet." She also said that successes in preventing mother-to-child transmission through antiretrovirals have led researchers to explore pre-exposure prophylaxis. The Inquirer reports that this is a "radical shift," as the drugs are "neither cheap nor nonprescription" and come with "the danger of unintended consequences." Forbes said, "In poor countries, what are the odds that prevention pills would be taken from a woman and given to a family member with HIV?" In addition, there is a concern that expanded use of antiretrovirals could lead to drug resistance, "undermining treatment as well as prevention," the Inquirer reports (McCullough, Philadelphia Inquirer, 3/23).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
суббота, 10 сентября 2011 г.
Brownback Reiterates Pledge That He Will Try To Overturn Roe If Elected President
Sen. Sam Brownback (Kan.), who is running for the Republican presidential nomination, on Saturday at a campaign event in West Des Moines, Iowa, reiterated his pledge that, if elected, he will try to overturn Roe v. Wade, the 1973 Supreme Court ruling that effectively barred state abortion bans, through appointing a Supreme Court justice, the Des Moines Register reports. Speaking at the Crossroads Fellowship, Brownback said the court is just one justice away from enough votes to overturn Roe, adding, "I want to be the president that appoints that justice" (Kauffman, Des Moines Register, 7/15).
Brownback attended seven campaign events throughout Iowa from July 13 to July 15 as part of his "Pro-Life, Whole-Life Tour," according to the Daily Iowan (Patton, Daily Iowan, 7/16). At another campaign event Saturday in Odebolt, Iowa, Brownback called on Rep. Tom Tancredo (Colo.), who also is running for the Republican nomination, to return campaign contributions from a longtime supporter who gave donations to a Planned Parenthood affiliate in Michigan, the Denver Rocky Mountain News reports (Sprengelmeyer, Denver Rocky Mountain News, 7/16).
Brownback on Saturday in an interview following the event said, "I've had people who've given funds to my campaign (but) when I saw where they were on the issues, I said, 'I don't want to associate with those individuals.'" Tancredo, who also attended the event, in an interview said, "Sen. Brownback knows better," adding, "He knows how I feel on the position of life (opposing abortion). It's disappointing. It's not a mark of a campaign with great integrity" (Rocky Mountain News, 7/16).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Brownback attended seven campaign events throughout Iowa from July 13 to July 15 as part of his "Pro-Life, Whole-Life Tour," according to the Daily Iowan (Patton, Daily Iowan, 7/16). At another campaign event Saturday in Odebolt, Iowa, Brownback called on Rep. Tom Tancredo (Colo.), who also is running for the Republican nomination, to return campaign contributions from a longtime supporter who gave donations to a Planned Parenthood affiliate in Michigan, the Denver Rocky Mountain News reports (Sprengelmeyer, Denver Rocky Mountain News, 7/16).
Brownback on Saturday in an interview following the event said, "I've had people who've given funds to my campaign (but) when I saw where they were on the issues, I said, 'I don't want to associate with those individuals.'" Tancredo, who also attended the event, in an interview said, "Sen. Brownback knows better," adding, "He knows how I feel on the position of life (opposing abortion). It's disappointing. It's not a mark of a campaign with great integrity" (Rocky Mountain News, 7/16).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
суббота, 3 сентября 2011 г.
Mother's Day And National Women's Health Week To Raise Awareness Of Gestational Diabetes
Most women with gestational diabetes know that taking steps to manage the disease during pregnancy is critical for the health of both mother and child. What many women don't realize is that those steps need to continue even after the baby is born.
Women who have had gestational diabetes are at increased risk for developing diabetes in the future, and their child is also at increased risk for obesity and type 2 diabetes. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Women's Health (ORWH) at the National Institutes of Health are teaming up this May to raise awareness of these risks as part of the National Diabetes Education Program's (NDEP's) "It's Never Too Early...to Prevent Diabetes" campaign.
"As we celebrate Mother's Day and National Women's Health Week May 9 through 15, we want all mothers with a history of gestational diabetes to be aware of their long-term health risks, the health risks faced by their children, and steps they can take to keep themselves and their families healthy," said Griffin P. Rodgers, M.D., director of the NIDDK.
Gestational diabetes occurs during pregnancy and affects about 7 percent of all U.S. pregnancies, or about 200,000 pregnancies each year. Women who have had gestational diabetes should be re-tested for diabetes six to 12 weeks after the baby is born, and at least every three years after that.
"Many women think that if the follow-up test after the baby is born shows no signs of diabetes, they are in the clear, but that's not the case," said Vivian Pinn, M.D., director of the ORWH. "What many of these moms don't know is that they have a 40 percent to 60 percent chance of developing diabetes as early as five to 10 years after their baby is born. These women need to know this information and they need to take steps to lower their risk for developing diabetes."
Women with a history of gestational diabetes can do a lot to prevent or delay the risk of developing diabetes. In addition to screening for diabetes, it is important for women to reach and maintain a healthy weight by making healthy food choices and being active for at least 30 minutes, 5 days a week. These action steps are good for the entire family and help mom and baby manage their risks for developing diabetes. Breastfeeding also helps protect against childhood obesity, which is a risk factor for type 2 diabetes. For mom, breastfeeding can also promote an earlier return to pre-pregnancy weight.
Gestational diabetes occurs more frequently among women with a family history of diabetes; overweight and obese women; and Hispanic/Latina, African-American, American Indian, Asian, Pacific Islander and Alaska Native women. Women who have had gestational diabetes should be screened regularly for diabetes and pre-diabetes, a condition where blood glucose levels are higher than normal, but not high enough to be diagnosed as diabetes. Follow-up screening usually consists of a simple blood test.
It is important that women talk to their doctors about their history of gestational diabetes. Women with a history of gestational diabetes should also talk to their obstetricians about earlier screening for gestational diabetes in future pregnancies. Because the children of women who had gestational diabetes are also at increased risk for obesity and type 2 diabetes, it's a good idea for mothers who had gestational diabetes to tell their child's pediatrician.
For a free tip sheet on gestational diabetes, including steps to reduce the risk of developing diabetes, call the National Diabetes Education Program at 1-888-693-NDEP (6337) or visit here. In addition, Women's Health Resources, a Web Portal developed by the National Library of Medicine and ORWH, will highlight NDEP materials and NIH research on gestational diabetes during National Women's Health Week, May 9 through 15.
The NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit here.
The NIH's Office of Research on Women's Health serves as the focal point for women's health research at the NIH. For more information about NIH's Office of Research on Women's Health, visit orwh.od.nih.
The National Diabetes Education Program, jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations, provides diabetes education to improve the treatment and outcomes for people with diabetes, promote early diagnosis, and prevent or delay the onset of diabetes. For more information, visit here.
Source
National Institutes of Health (NIH)
Women who have had gestational diabetes are at increased risk for developing diabetes in the future, and their child is also at increased risk for obesity and type 2 diabetes. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Women's Health (ORWH) at the National Institutes of Health are teaming up this May to raise awareness of these risks as part of the National Diabetes Education Program's (NDEP's) "It's Never Too Early...to Prevent Diabetes" campaign.
"As we celebrate Mother's Day and National Women's Health Week May 9 through 15, we want all mothers with a history of gestational diabetes to be aware of their long-term health risks, the health risks faced by their children, and steps they can take to keep themselves and their families healthy," said Griffin P. Rodgers, M.D., director of the NIDDK.
Gestational diabetes occurs during pregnancy and affects about 7 percent of all U.S. pregnancies, or about 200,000 pregnancies each year. Women who have had gestational diabetes should be re-tested for diabetes six to 12 weeks after the baby is born, and at least every three years after that.
"Many women think that if the follow-up test after the baby is born shows no signs of diabetes, they are in the clear, but that's not the case," said Vivian Pinn, M.D., director of the ORWH. "What many of these moms don't know is that they have a 40 percent to 60 percent chance of developing diabetes as early as five to 10 years after their baby is born. These women need to know this information and they need to take steps to lower their risk for developing diabetes."
Women with a history of gestational diabetes can do a lot to prevent or delay the risk of developing diabetes. In addition to screening for diabetes, it is important for women to reach and maintain a healthy weight by making healthy food choices and being active for at least 30 minutes, 5 days a week. These action steps are good for the entire family and help mom and baby manage their risks for developing diabetes. Breastfeeding also helps protect against childhood obesity, which is a risk factor for type 2 diabetes. For mom, breastfeeding can also promote an earlier return to pre-pregnancy weight.
Gestational diabetes occurs more frequently among women with a family history of diabetes; overweight and obese women; and Hispanic/Latina, African-American, American Indian, Asian, Pacific Islander and Alaska Native women. Women who have had gestational diabetes should be screened regularly for diabetes and pre-diabetes, a condition where blood glucose levels are higher than normal, but not high enough to be diagnosed as diabetes. Follow-up screening usually consists of a simple blood test.
It is important that women talk to their doctors about their history of gestational diabetes. Women with a history of gestational diabetes should also talk to their obstetricians about earlier screening for gestational diabetes in future pregnancies. Because the children of women who had gestational diabetes are also at increased risk for obesity and type 2 diabetes, it's a good idea for mothers who had gestational diabetes to tell their child's pediatrician.
For a free tip sheet on gestational diabetes, including steps to reduce the risk of developing diabetes, call the National Diabetes Education Program at 1-888-693-NDEP (6337) or visit here. In addition, Women's Health Resources, a Web Portal developed by the National Library of Medicine and ORWH, will highlight NDEP materials and NIH research on gestational diabetes during National Women's Health Week, May 9 through 15.
The NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit here.
The NIH's Office of Research on Women's Health serves as the focal point for women's health research at the NIH. For more information about NIH's Office of Research on Women's Health, visit orwh.od.nih.
The National Diabetes Education Program, jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations, provides diabetes education to improve the treatment and outcomes for people with diabetes, promote early diagnosis, and prevent or delay the onset of diabetes. For more information, visit here.
Source
National Institutes of Health (NIH)
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