суббота, 9 июня 2012 г.
GlaxoSmithKline Announces Swiss Approval Of Tyverb®, A New Oral Treatment For Advanced Breast Cancer
Lapatinib is a small molecule that is administered orally and works by getting inside the cancer cell and inhibiting two receptor proteins the tyrosine kinase components of ErbB1 and ErbB2 receptors, which are responsible for tumour growth. This innovative mechanism of action is a new way to treat breast cancer and is different from current targeted therapies for ErbB2 positive disease.
This approval was based on a pivotal Phase III trial (EGF100151) in women with advanced ormetastatic ErbB2 positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The data showed that the median time to progression was 27.1 weeks on the combination of lapatinib and capecitabine versus 18.6 weeks on capecitabine alone (hazard ratio 0.57 (CI 0.43, 0.77) p=0.0001). The response rate was 23.7% versus 13.9% (p=0.017).[1]
The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea and vomiting) or skin toxicities (hand and foot syndrome and rash). The majority of adverse events and laboratory abnormalities were mild to moderate in severity and were not significantly higher than those seen with capecitabine monotherapy.
"This is an extremely significant and exciting breakthrough for patients and physicians across Switzerland. Lapatinib offers patients an effective, well-tolerated treatment and as an oral therapy offers added convenience for patients. Lapatinib is now available in Switzerland and subject to regulatory approval we remain ontrack to launch lapatinib in the rest of Europe during the second half of 2007" said Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre at GSK. "The approval of lapatinib demonstrates our R&D organisation's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of lapatinib in a variety of settings including early breast cancer as well as in other types of cancer."
Brain Metastases as Relapse Site
Brain metastases develop in one third of women with ErbB2 (HER-2) positive metastatic breast cancer, and is an area of significant unmet medical need. Once the disease advances to this site, overall prognosis is poor with the average one-year survival estimated at about 20 percent.[2]
In the Phase III trial on which the Swiss approval is based, preliminary results suggest that lapatinib may play a role in decreasing the development of brain metastases as site of first relapse. CNS relapse were lower in the lapatinib plus capecitabine arm versus the capecitabine alone arm.i Additional studies are ongoing in an effort to confirm this preliminary finding.
Future for Lapatinib - Ongoing Clinical Trials
Further studies are ongoing and are investigating the use of lapatinib either alone or in combination with other therapies for the treatment of breast cancer in women that are ErbB2 positive, including first-line in previously untreated metastatic breast cancer, as well as an adjuvant therapy for primary or early breast cancer. Trials are also ongoing in a range of other solid tumours that overexpress ErbB1 and/or ErbB2, including head & neck and renal cell cancer.[3],,[4]
GSK in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary "bench to bedside" approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.
About GlaxoSmithKline
GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at gsk.
Tyverb® and Tykerb® are registered trade marks of the GlaxoSmithKline group of companies.
Tykerb® (lapatinib) is available in the United States and has received regulatory approval in Bahrain, Kuwait, and conditional approval in UAE.
Lapatinib has not received regulatory approval in the European Union. A registration dossier has been filed with the European Medicines Agency. Tyverb® is the proposed trade mark for lapatinib in the European Union, subject to regulatory approval.
Registration dossiers for lapatinib (under the trade mark Tykerb®) have been filed in Australia, Canada, New Zealand and a number of countries in Asia, Latin Americaand the Middle East.
References:
[1] Tyverb® Prescribing Information. GSK data on file.
[2] Weil R. et al. Breast Cancer Metastasis to the Central Nervous System. American Journal of Pathology. 2005;167:913-920.
[3] El-Hariry, I., Harrington K. et al. A phase I, open label study (EGF100262) of lapatinib plus chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Oral presentation, 1st International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain. 22nd - 24th February 2007.
[4] Ravaud A, Gardner, R. Hawkins H et al. Efficacy of lapatinib in patients with high Tumour EGFR expression: Results of a phase III trial in advanced renal cell carcinoma (RCC).Journal of Clinical Oncology, 2006 ASCO Annual Meeting ProceedingsPartI.Vol 24, No. 18S (June 20 Supplement) 2006:
View drug information on Tykerb.
суббота, 2 июня 2012 г.
Nepalese Maternal Mortality Rate Among Highest Worldwide, IFRC Report Says
"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, 26 мая 2012 г.
TAXUS WOMAN Study Reports Positive Clinical Outcomes For The TAXUS Drug-Eluting In Women
"This study of data from the TAXUS trials offers encouraging news for women with coronary artery disease," said Ghada Mikhail, M.D., Consultant Cardiologist, St Mary's Hospital Trust, London, UK. "Previous trials and registries have demonstrated a less favorable clinical outcome in women compared to men when undergoing coronary revascularization with bare-metal stents. That difference has been previously explained by the smaller vessels and higher risk profile seen in women. These data show, however, that the TAXUS paclitaxel-eluting coronary stent works equally well in women, maintaining its anti-restenotic efficacy advantages and positive safety profile relative to bare-metal stents."
"Heart disease is the number one cause of death among women in the United States, and more women than men die from cardiovascular disease each year," said Hank Kucheman, Senior Vice President and Group President, Interventional Cardiology. "The findings of the TAXUS WOMAN study show the clear and sustained benefit of the TAXUS stent in women with heart disease."
The TAXUS II, IV, V and VI trials evaluated the performance of the TAXUS paclitaxel-eluting stent (PES) compared to a bare-metal stent (BMS) control in patients with coronary artery disease. The TAXUS WOMAN study analysed pooled results of the women enrolled in these TAXUS trials and compared them with the corresponding endpoints in men.
Of the 3,445 patients enrolled in the TAXUS trials between June 2001 and March 2004, 955 (27.7%) were women. Of these women, 480 received PES and 475 received BMS. Of the 2,490 men enrolled, 1,238 received PES and 1,252 received BMS. As compared to men, women were older (mean age 65.4?±10.9 years versus 61.0?±10.4 years), had smaller body surface area (1.80?±0.19m2 versus 2.05?±0.20m2), had more diabetes (30.4% versus 21.0%), had more hypertension (78.0% versus 65.1%), had smaller vessels (pre-procedure reference vessel diameter 2.63?±0.46mm versus 2.78?±0.52mm), and had more history of coronary artery disease (62.2% versus 54.7%) (p for all
суббота, 19 мая 2012 г.
Advocacy Group Launches Ads Urging Massachusetts Gov. Patrick To Accept Federal Abstinence-Only Sex Education Grant
According to the Sexuality Information and Education Council of the United States, eight other states have rejected the funding, which requires that sex education curricula promote abstinence until marriage, and 12 additional states are considering not applying for the grant. In rejecting the funding, Patrick's administration cited a study commissioned by Congress and released in June that found students who participate in abstinence-only programs are as likely to have sex as students who do not participate in the programs.
Dorchester, Mass.-based Healthy Futures -- which teaches abstinence education to 7,000 middle school students annually -- has said it will lose about $500,000, or about 50% of its annual budget, without the federal grant. Rep. Brad Jones (R) in July said he will call on the Republican leadership in the Legislature to attempt to override Patrick's veto. However, Patrick could still decide not to apply for the grant if his veto is overridden (Kaiser Daily Women's Health Policy Report, 7/19).
According to the AP/Boston Globe, NAEA has spent $75,000 for the media campaign, which will issue ads in newspapers and on the radio. One of the ads says, "Deval Patrick Doesn't Want 11-Year-Olds Taught To Say 'No' to Sex." The group also has launched a Web site urging Patrick to accept the funds.
Patrick spokesperson Kyle Sullivan called the ad "a complete and utter distortion of the facts" (AP/Boston Globe, 9/6). JudyAnn Bigby, secretary of health and human services, said the Patrick administration will not change its mind, adding that although abstinence is part of comprehensive sex education, restrictions on the federal grant "require that we teach things that are either unfounded in fact or are very biased in terms of the values."
Valerie Huber, director of NAEA, said that Patrick's veto is "taking away the freedom of choice for Massachusetts schools to select abstinence education." She added that Massachusetts is the first state targeted in NAEA's ad campaign but that more could come (Boston Herald, 9/6).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
суббота, 12 мая 2012 г.
Healthcare Watchdog Renews Call For Robust Safety Checks In Maternity Units As Investigation Describes Deaths Of 10 Women, UK
The findings have prompted the inspectorate to renew its call for NHS trusts to check that they have robust systems for monitoring the safety of maternity units.
The report describes what happened to each of the ten women, all of whom died during pregnancy or within 42 days of giving birth between April 2002 and April 2005. This number of deaths was significantly higher than the national average for maternity.
In April last year, the Commission stepped in and recommended that the Government place North West London Hospitals NHS Trust under special measures, calling in an external team to safeguard women at Northwick Park Hospital's maternity unit.
This report, which aimed to identify if there were common factors between the deaths, paints a stark picture of what can happen when a maternity unit has inadequate systems to protect the women it cares for.
The Commission criticises the quality of care given by the Trust in nine out of the ten cases.
Common factors include:
-- insufficient input from a consultant or a senior midwife (in five cases), with difficult decisions often left to junior staff.
-- failure in a number of cases to recognise and respond quickly where a woman's condition changed unexpectedly
-- inadequate resources to deal with high-risk cases: too few consultant obstetricians and midwives; not enough dedicated theatre staff; a reliance on agency and locum staff without adequate managerial or professional support; and a lack of a dedicated high dependency unit
-- a working culture that led to poor working practices and resulted in poor quality of care
-- failure to learn lessons on the unit - the Trust took action following the deaths but the working environment was such that mistakes were repeated
-- failure by the Trust's board to appreciate the seriousness of the situation - the board was aware of the high number of deaths, and should have acted sooner to rectify problems.
The Commission does not criticise all aspects of the hospital's care. Anaesthetic staff and the haematology department, which provided blood for the patients, were praised for responding well under difficult circumstances.
The Trust remains under special measures, but the Commission says there have been significant improvements in the maternity services provided there. These have included the recruitment of three additional consultants and 20 more midwives.
The inspectorate also believes there is now better team working between consultants and the obstetric staff, and between the obstetric staff and midwives.
Marcia Fry, the Commission's Head of Operational Development, said: "This was a sad and tragic series of events. We hope this report at least gives some answers to the families involved.
"At the time of the deaths, the working practices at the Trust were unacceptable. However, under special measures the Trust has got its maternity services on the road to recovery. We will continue to work with them to ensure that they continue to progress and that everything possible is done to stop this happening again."
Mrs. Fry added: "We expect trusts across the country to read this report and learn the lessons. Most women in this country give birth safely. But there are risks and the NHS must ensure it does all it can to reduce them. There can be no excuse for failing to learn the lessons from tragedies of this kind."
This is the Commission's second report into Northwick Park Hospital's maternity services. The first, in July 2005, identified system failures including lack of leadership and weak risk management. This report outlines the impact on the ten women concerned.
Last year, Commission Chairman Sir Ian Kennedy called on NHS trusts to raise standards in their maternity services to those of the best. He drew on the similarities between Northwick Park and two other trusts where maternity services had been investigated.
Sir Ian said the overall root cause of poor performance is often weak managerial or clinical leadership which can leave problems unidentified or unresolved. He also highlighted:
-- weak risk management with poor incident reporting and complaints handling
-- poor working relationships and working in multi-disciplinary teams
-- inadequate training and supervision of clinical staff
-- poor environment with services isolated geographically or clinically
-- shortages of staff coupled with poor management of temporary employees.
The Commission is stepping up its assessments of maternity services, which will provide it with information on patient experience and clinical outcomes. It is planning a major survey of looking at women's experience of maternity care, as well as a national review of maternity units, which will include clinical indicators that enable NHS trusts to compare their performance.
-- Investigation into 10 maternal deaths at, or following delivery at, Northwick park Hospital, North West London Hospitals NHS Trust, between April 2002 and April 2005 (pdf 920kb)
-- More information about North West london Hospitals NHS Trust
About the Investigation
-- On 15 August 2006 the Commission conducted an unannounced visit at Northwick Park's maternity unit. The Commission looked at antenatal, post-natal and delivery services. The Commission was satisfied that progress has been made in these three areas and that there was improvement in working practices at the unit.
-- This second investigation was conducted between June 2005 and June 2006
-- Healthcare Commission staff worked with a team of clinical advisors with specialist knowledge of maternity services, anaesthetic services and the management of risk. Additional specialist advice was sought from a consultant haematologist, a consultant cardiologist and a consultant hepatobiliary liver transplant surgeon
-- The investigation team reviewed the clinical records of the ten women who died and the documentation from the trust's internal and external reviews of their deaths. This included previous statements made by staff, inquest transcripts and other external reports
-- The team also reviewed information from other trusts that were involved in events leading up to the deaths of the ten women. Interviews were conducted with 46 NHS staff (both past and present employees of the trust)
-- Each of the families of the ten women were invited to meet with the Commission's investigation team. Meetings were held with five of the families and one family responded in writing
-- The national average for maternal deaths as reported by CEMACH is one death per 8,775 maternities or 11.4 deaths per 100,000 maternities. The maternal death rate for Northwick Park maternity unit (in the period April 2002 to March 2004) was 74.2 deaths per 100,000 maternities
About the Healthcare Commission
---- The Healthcare Commission is the independent inspection body for both the NHS and the private and voluntary healthcare sectors. It exists to promote improvements in the quality of healthcare in England and Wales
---- The Healthcare Commission has a legal obligation under the Health and Social Care Act 2003 to report significant failings to the Secretary of State; this may also include recommendations for special measures. Special measures are designed to generate improvements where other methods have failed, or are considered likely to do so.
---- The Healthcare Commission has 15 commissioners and is chaired by Professor Sir Ian Kennedy who was chairman of the public inquiry into children's heart surgery at Bristol Royal Infirmary, published in 2001
---- Its roles in England include -
- assessment of performance of health service providers against Government standards
- investigation of serious failures in healthcare services
- independent review of complaints about the NHS which have not been resolved locally
- rating the performance of NHS hospitals and trusts
- publication of an annual report on healthcare performance
Further information on the Healthcare Commission is available on healthcarecommission
суббота, 5 мая 2012 г.
Separating Fact From Fiction: The Truth About Nutrition In Pregnancy
careful to eat healthfully and pregnancy is a great time to learn,
according to a leading nutrition expert.
Marion Nestle, Ph.D., M.P.H., a nationally-renowned nutritionist and
author, said women who are pregnant or thinking about getting pregnant
should use this time to learn the basics of good nutrition before, during
and after pregnancy. The basic principles of healthful diets apply even
more to pregnancy: eat enough (but not too much); stay active; eat plenty
of fruits, vegetables, and whole grains; don't eat too much junk food; and
enjoy!
Dr. Nestle spoke during a March of Dimes-sponsored National
Communications Advisory Council luncheon entitled "Mythbusters: Myths and
Misconceptions on Nutrition in Pregnancy." Dr. Nestle, who is the Paulette
Goddard Professor of Nutrition, Food Studies, and Public Health at the
Steinhardt School of Culture, Education, and Human Development at New York
University, said, "You have to be a savvy shopper about food just as you
would be with anything else you buy. If claims about a particular food or
product seem too good to be true, they undoubtedly are! Be a skeptic, do
some homework, ask questions. Rely on research, not opinion. And check any
major decision with your prenatal provider."
The March of Dimes says consumers have lots of questions about good
nutrition in pregnancy including: "Does salt have anything to do with
hypertension?"; "Is it okay to eat artificial sweeteners?"; and "Are herbal
supplements safe because they're 'natural'?"
Also speaking at the luncheon was Kim Saul, a vegetarian and the mother
of 3-year-old Quinn. "I knew a lot about eating well for my own health, but
when I got pregnant I learned some important food tips from my
obstetrician. I didn't need more protein, but did have to add calcium and
keep my iron levels up. I limited fish that might have high mercury
content. I also ate eggs, but made sure they were cooked thoroughly. I
didn't overdue anything. For me, moderation was and is the key."
The March of Dimes works to improve the health of babies by preventing
birth defects, premature birth and infant mortality.
March of Dimes
marchofdimes
суббота, 28 апреля 2012 г.
Texas Lawmakers Divert Millions From Family Planning Clinics To Community Health Centers
The most significant funding change occurred in 2005, when almost 25% of the state's $45 million annual family planning budget was set aside for "federally qualified health centers" -- community health centers that offer services to uninsured and underserved people. Advocates for family planning clinics say that the number of patients receiving state-funded reproductive services declined by nearly 22%, from 326,000 patients in 2005 to 255,000 in the last fiscal year. They also note that the community health centers have an unused surplus of more than $11.5 million since 2005, which they say the family planning clinics could have used.
According to the Morning News, many public health experts believe that specialty clinics that have family planning services offer more efficient and effective reproductive care than community health centers. David Warner, a health care finance and policy expert at the University of Texas Lyndon B. Johnson School of Public Affairs, said the specialty clinics are "very targeted" and "don't have a lot of overhead," whereas the community clinics have "limited enrollment and can be a lot less accessible." He added, "Continuing to starve those clinics means that you're not going to be reaching the number of people you could be reaching with family planning services." Family planning clinics in Texas offer more than a dozen services ranging from birth control prescriptions to breast and cervical cancer screening and sexually transmitted infection testing. However, reproductive health advocates say many people often associate the clinics with abortion services, which gives antiabortion-rights lawmakers an incentive to shut down the clinics by withholding funding. Fran Hagerty, CEO of the Women's Health and Family Planning Association of Texas, said, "Some lawmakers believe if they can prevent Planned Parenthood from participating in the state's family planning program, then they've accomplished their goal."
Supporters of community health centers say that billing issues and other administrative problems have distorted their data on how many reproductive health patients they are treating. Many women receive care at the community centers for family planning services along with treatment of other health problems, so they often are not recorded as reproductive health patients, according to the centers (Ramshaw, Dallas Morning News, 5/22).
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, 21 апреля 2012 г.
Mexico City Legislature Approves Bill That Legalizes Abortion During First Three Months' Gestation
Reaction
The Legislature's vote "is a triumph for democracy," Maria Consuelo Mejia of the group Catholics for the Right to Choose said, adding, "It is a triumph for all women, and above all, for the poorest" women in the country. Lilian Sepulveda, an attorney with the Center for Reproductive Rights, said the passage of the bill is "going to make an enormous difference for women in Mexico City in their everyday lives" (Los Angeles Times, 4/25). Sepulveda added that "instead of back alleys, women will be able to go to the doctor's office to get the health services they need." Raffaela Schiavon, executive director of the reproductive rights group Ipas, said that the passage of the bill is "a huge victory." He added, "It could start a chain of similar initiatives in other Mexican states and be an example for other countries" (Ovalle, Miami Herald, 2/25). Marcelino Hernandez, auxiliary bishop of the Archdiocese of Mexico, earlier this month said that if the bill is signed into law, any lawmaker who voted in favor of the measure would be excommunicated from the Catholic Church when the first abortion is performed under the law (Kaiser Daily Women's Health Policy Report, 4/24). Felipe Aguirre Franco, archbishop of Acapulco, said lawmakers who voted to approve the measure "will get the penalty of excommunication," adding, "That is not revenge, it is just what happens in the case of serious sins" (Bremer, Reuters, 4/25). Mexican Federal Health Secretary Jose Angel Cordova Villalobos, an abortion-rights opponent, on Tuesday said there would be nothing to prevent residents of other Mexican states from coming to Mexico City to receive abortions at private and public clinics. He added that the new law likely would allow doctors to establish abortion clinics in the city (Los Angeles Times, 4/25).
"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, 14 апреля 2012 г.
Neurocrine Announces Full Year Results From 603 Study (Petal Study) Of Elagolix For Treatment Of Endometriosis Pain
"As expected, elagolix did not induce significant bone loss over the six-month follow up phase of the Petal Study," said Chris O'Brien, MD, Neurocrine's Chief Medical Officer. "Additionally, we are seeing for the first time an oral GnRH antagonist with a rapid and sustained symptom reduction during treatment that also provides a statistically and clinically significant improvement in symptoms which persists after discontinuation of therapy. These are intriguing results and raise the possibility that elagolix treatment may have a disease modifying effect."
Key findings include the following:
Bone Safety: As previously reported, the primary endpoint of the Petal Study, impact on bone mineral density (BMD), was met at Week 24. Neurocrine now has confirmation of a favorable bone safety profile at Week 48 with no cumulative reduction in BMD evident. Mean change from baseline for elagolix 150 mg qd remained at close to 0% at Week 48, with n-telopeptide values remained close to a mean of 10 nM BCE (normal range 6-19 nM BCE for this age group).
Pain reduction: Sustained improvement at Week 48 compared to baseline was demonstrated (p
Quality of Life: The Endometriosis Health Profile (EHP-5) assessed the impact of endometriosis symptoms on five core domains. At baseline, approximately 80% of subjects reported that they suffered difficulties across all domains "sometimes," "often" or "always." After treatment this shifted dramatically such that 60-80% of subjects said "never" or "rarely" to these same EHP-5 questions. Equally notable is the observation that much of this improvement was sustained post-treatment.
Estradiol and Ovulation: The previously reported pharmacodynamic effect of elagolix was confirmed. Median estradiol values were maintained in the low baseline range while on treatment and, most importantly, were not lowered to values that would be associated with hot flashes or clinically significant bone loss. As reported, Week 24 median estradiol was 47 pg/ml for elagolix once daily and 29 pg/ml for elagolix twice daily. At Week 48, the median values for the groups were normal at 80 pg/ml and 84 pg/ml, respectively. The mean time to ovulation post-treatment was 24 days for women who had been randomized to elagolix and >90% of subjects had evidence of ovulation within 4 weeks of stopping. Prolonged suppression of ovulation was documented, even out to Week 48 in the DMPA subjects who also reported frequent spotting and irregular vaginal bleeding.
Safety and Tolerability: Assessment of vital signs, physical examination, electrocardiogram, and clinical laboratory tests did not reveal any safety concerns. Adverse events that were reported were generally mild and transient in nature and not usually associated with study discontinuation. The most common adverse events in this trial were consistent with what we have observed in the other elagolix trials including headache (approximately 20% of subjects reported 1 or more headaches during the 6 months of treatment) and nausea (approximately 15% of subjects reported 1 or more episode of nausea). The most common reason for premature discontinuation from the study was withdrawal of consent (i.e., subject moved, work conflict, etc). Seven subjects withdrew from the study with excessive, prolonged or breakthrough bleeding attributed to DMPA. The reporting of adverse events decreased by 50% in the post treatment period; no pattern of specific safety concerns due to elagolix have been identified. Hot flashes were reported by approximately 40% of subjects during the screening period (mean 0.4 per day) and 40% during the treatment period (mean 0.7 per day). Approximately 25% of subjects reported hot flashes during the post-treatment period (mean 0.4 per day). No pattern of excessive estradiol suppression was detected.
The twelve-month data from the Petal Study will be presented at various upcoming scientific meetings and in manuscript form. The bone data from the Petal Study are scheduled for presentation at the Endocrine Society Meeting in Washington, DC on June 12, 2009. The Petal Study safety and efficacy data have been submitted for the American Society for Reproductive Medicine (ASRM) meeting scheduled this fall in Atlanta. A subset of the Petal Study subjects will return for Week 72 DXA scans and clinical assessments to satisfy earlier arrangements made in consultation with the FDA.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine related diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, irritable bowel syndrome (IBS), anxiety, depression, pain, diabetes, benign prostatic hyperplasia (BPH) and other neurological and endocrine related diseases and disorders.
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, as well as risks and uncertainties associated with the Company's GnRH program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's GnRH program include, but are not limited to, risk that the Company's elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Company's dependence on corporate collaborators for development, commercial manufacturing and marketing and sales activities. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company's dependence on contract manufacturers for clinical drug supply; risks associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection 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 products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2008 and report on Form 10-Q for the quarter ended March 31, 2009. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
Source: Neurocrine Biosciences, Inc
View drug information on Estradiol Transdermal System.
суббота, 7 апреля 2012 г.
San Francisco Chronicle Examines Differences In Federal, California Sex Education Policy
"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, 31 марта 2012 г.
Blogs Comment On Health Reform, Maternal Mortality, Other Topics
~ "Q&A with Carole Joffe," Katha Pollitt, The Nation's "And Another Thing": Pollitt interviewed Carole Joffe -- a sociologist and author of "Dispatches from the Abortion Wars: The Costs of Fanaticism to Doctors, Patients and the Rest of Us" -- about the health reform law's potential effects on reproductive rights and health. According to Joffe, the consequences of health reform include the "good, the bad and the ugly." The "unequivocal good is that 30 million people" will gain insurance coverage, and "[r]egular access to primary care will mean healthier women overall," Joffe said. She continued, "The bad news is the Nelson abortion restrictions ... will prove so cumbersome that ultimately it will not be in [insurance] companies' interest to cover abortions. The ugly part is the marginalization of abortion all through the process." Joffe said the erosion of abortion coverage will have an especially strong impact on "women who require abortions late in their pregnancies because of lethal or serious fetal anomalies or a change in their own health," such as a cancer diagnosis that requires chemotherapy, because late abortion services can cost thousands of dollars. Going forward, the abortion-rights movement should continue to focus on "[k]eeping providers safe," Joffe said, adding that "[e]lecting more pro-choice Democrats" also "is a huge priority." She continued, "But the most important thing that needs to be done is the hardest: we need to destigmatize abortion. We need to create the conditions where it is not toxic for politicians who support us to actually say the 'a-word' and not rely on the euphemism 'right to choose'" (Pollitt, "And Another Thing," The Nation, 3/26).
~ "The Maternal Mortality Crisis Does Exist," Nan Strauss, Salon's "Broadsheet": In the post, Strauss -- a maternal health researcher at Amnesty International -- defends the group's recent report, "Deadly Delivery: The Maternal Health Care Crisis in the USA." Specifically, Straus addresses Amy Tuteur's recent blog post, "Is there really a 'maternal mortality crisis'?" Strauss writes, "To quibble over whether there is an increase in maternal deaths is to ignore the key and undisputed fact: Women in the United States face a greater risk of death from pregnancy-related causes than women in 40 other countries, despite the fact that we spend the most of any country on health care." She continues, "While changes in data reporting have contributed to the increase in reported maternal deaths, the most recent analysis indicates that improvements in data collection only account for a fraction of the increase in deaths." Although rising caesarean section rates "undoubtedly do not account for the entire increase in deaths, ... the World Health Organization has found that when the c-section rate exceeds 15%, unnecessary surgeries put women and babies at risk," Strauss writes, noting that the U.S. c-section rate is twice the level that WHO recommends. Strauss adds, "Regardless of whether the death toll is rising, or whether improved reporting is shining a new light on existing high rates of maternal deaths, these shocking figures reveal a health system in crisis." She concludes, "It is incumbent on President Obama and [HHS Secretary] Kathleen Sebelius to make improving maternal health a top priority" (Strauss, "Broadsheet," Salon, 3/26).
~ "Health Care Reform Extremists Take a Page From an Ugly Anti-Choice Playbook," Sarah Lipton-Lubet, The Hill's "Congress Blog": Lipton-Lubet, legislative policy counsel at the Center for Reproductive Rights, writes, "Many Americans are shocked that a debate over expanding health care access has spiraled into death threats and vandalism." She adds, "Unfortunately, the pro-choice community is all too familiar with these tactics as a response to the provision of basic health care." Lipton-Lubet continues that after the murder of abortion provider George Tiller in 2009, CRR released a report "documenting the harassment, intimidation, discrimination and violence perpetrated against the brave men and women who provide abortions, or counsel women about their options, or check them in at reception desks." She continues, "Not content with their victories in legislatures or at the voting booth, anti-choice extremists have long resorted to murder, bombings, arsons and assaults." According to Lipton-Lubet, "Whatever side you're on regarding either the debate over health care or abortion rights, enough is enough." She writes, "It is time for threats and harassment to end, and for responsible leaders to recognize that access to health care -- including reproductive health care -- is a fundamental right and not a cause for mayhem" (Lipton-Lubet, "Congress Blog," The Hill, 3/29).
~ "Conservative Cartoonist Uses Rape and Racism in Depicting Health Reform," Jodi Jacobson, RH Reality Check: Jacobson describes abortion-rights supporters' reaction to a "drawing by a conservative cartoonist using a blatantly racist rape meme to ramp up their hysteria over health reform." According to Jacobson, the cartoon depicts "President Obama as having raped the Statue of Liberty." Amanda Marcotte of Pandagon notes that the cartoon also depicts the president as "promis[ing] to come back to gang rape her with immigration reform, amongst other things." Marcotte writes, "The callousness to actual rape victims on display here is simply a more explicit version of a rhetorical trope that's been in play since Obama took office and has really escalated as the favorite metaphor used by conservatives to describe health care reform." Marcotte continues, "When it comes to actual rapes, the right-wing position is that the problem of rape is way overblown, and that most rapes -- most anything that gets called a date or acquaintance rape -- aren't a matter of men forcing themselves on women because they enjoy raping, but just bad sex that sluts regret later and therefore 'cry rape.'" Jacobson also provides links to posts by Jeff Fecke and Lawyers, Guns and Money about the cartoon (Jacobson, RH Reality Check, 3/27).
~ "No Health Care for Wanted Pregnancies, No Abortions for Unwanted Ones," Alex DiBranco, Change's "Women's Rights": "In Nebraska, if you don't want to be pregnant, anti-choice lawmakers will do their best to force you to act as an incubator," but "if you do want to give birth, then they couldn't care less if your newborn baby dies due to their laws," DiBranco writes. DiBranco criticizes Gov. Dave Heineman's (R) opposition to proposed legislation that "would have continued the state's longstanding practice of providing prenatal care for low-income women" because of his objections to allowing undocumented immigrants to receive state-funded services. Heineman's stance ultimately harms the "U.S. citizen baby who will eventually be born," according to DiBranco. DiBranco also discusses a bill (LB 594) that "would require proof that women seeking an abortion are physically and mentally sound enough to [receive] an abortion." According to DiBranco, "We don't go around requiring women to prove they're physically and mentally stable enough to bring a new life into this world, but we're going to impose unconstitutionally vague, impossible to comply with extra restrictions if they don't want that responsibility?" Taken together, the Nebraska issues "show again that, for the anti-choice camp, [the] only 'babies' that matter are the unborn," DiBranco says, adding, "Seems a lot more like controlling a woman's body than being 'pro-life'" (DiBranco, "Women's Rights," Change, 3/29).
~ "Anti-Choice Lawmakers Post-Health Care Reform Track," Nancy Keenan, Huffington Post blogs: While the House debated health care reform legislation, several antiabortion-rights members "suddenly claimed the belief that Americans' health care decisions should be private -- despite their own long, stubborn history of attempts to deny women the very same right," NARAL Pro-Choice America President Keenan writes. Keenan's entry includes several quotes from a "comprehensive list" of lawmakers who cited privacy concerns in statements opposing the health reform legislation and notes the number of times they have previously voted against protecting privacy in opposing abortion-related legislation. For example, Rep. Ileana Ros-Lehtinen (R-Fla.) said the health reform law "places control in the hands of government bureaucrats, rather than letting Americans decide for themselves what is best for their families." Keenan notes that Ros-Lehtinen "has cast 148 votes opposing reproductive freedom and privacy during her congressional career." Keenan says that "[p]erhaps in the future they will bring these newfound views to debates about reproductive health ... but I won't hold my breath" (Keenan, Huffington Post blogs, 3/29).
~ "The New Health Reform Law: Pros and Cons for Reproductive Health," Adam Sonfield, RH Reality Check: "For the nation's consumers and providers of reproductive health care, and for advocates of reproductive health and rights, the health care reform legislation just enacted is something of a mixed bag," Sonfield writes. The bill's abortion provisions are "onerous" and "restrictive," and they "militate heavily against the likelihood that many such plans will be purchased -- or even offered," according to Sonfield. The legislation contains $75 million annually for five years to fund a new "personal responsibility education program" to educate teens about both abstinence and contraception, but the law also includes funding for abstinence-until-marriage programs. By expanding Medicaid eligibility, more U.S. residents will gain access to "the program's guarantee of family planning services without cost sharing, along with coverage for its comprehensive package of reproductive health services beyond family planning," Sonfield writes. Plans included in the new insurance exchanges will be required to offer certain services, including maternity care and potentially "coverage of a broad package of reproductive health services, including contraceptive services and supplies," Sonfield adds. In addition, the law includes "$1.5 billion over five years to support maternal, infant and early childhood home visiting programs, with a focus on high-risk families," Sonfield writes (Sonfield, RH Reality Check, 3/30).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
суббота, 24 марта 2012 г.
Kansas Judge Assigns Abortion Provider Tiller's Case To New Judge Because Of Alleged Conflicts Of Interest
The antiabortion group Operation Rescue on Thursday said Waller could have conflicts of interest related to the case and cited support he had received in past campaigns from attorneys linked to Tiller, the AP/Topeka Capital-Journal reports. Don Monnat, one of Tiller's attorneys, contributed $500 in August 1998, the maximum allowed. Lee Thompson, who also serves as one of Tiller's attorneys, and Monnat were listed in an October 1998 newspaper as endorsing Waller's re-election. Monnat's law firm also contributed $275 to Waller's 2006 campaign (Hanna, AP/Topeka Capital Journal, 8/10).
According to the AP/Globe,Powell voted regularly for restrictions on abortion laws, including a 1998 law restricting late-term abortions. Powell in 1998 said Tiller was "defying legal and moral authority" by performing late-term abortions. Waller said that he did not know about Powell's past legislative activities, adding that he selected him because he was "the most available" for a hearing. Powell on Friday during a hearing for the case said his judgment would not be affected. He also asked attorneys if they objected to his appointment. Thompson said, "We trust the court's judgment in that regard" (AP/Joplin Globe, 8/10).
Case History
Former state Attorney General Phill Kline (R) in 2004 subpoenaed the records of 90 women and girls who in 2003 underwent late-term abortions at Comprehensive Health in Overland Park, Kan., and Women's Health Care Services in Wichita, Kan., which is owned by Tiller. Kline charged Tiller with 30 misdemeanors for allegedly performing 15 illegal late-term abortions in 2003 on women and girls ages 10 to 22 without properly reporting the details to the state. Kline hired attorney Don McKinney as special prosecutor in the case. State Attorney General Paul Morrison (D) -- who defeated Kline in the November 2006 election -- fired McKinney in January, and Morrison spokesperson Ashley Anstaett earlier this year said that 15 of the 30 charges Kline filed against Tiller were based on incomplete and substandard information.
However, Morrison in June filed charges alleging that before performing 19 late-term abortions in 2003, Tiller received a second opinion from physician Ann Kristin Neuhaus, who Morrison said had financial ties with Tiller. The 1998 Kansas law says that before an abortion of a fetus of 21 weeks' gestation or more, two physicians must determine if continuation of a pregnancy will lead to death or "substantial and irreversible" harm to a "major bodily function." The consulting physician agreeing on the necessity of a late-term abortion cannot have legal or financial ties to the abortion provider.
If convicted, Tiller could face up to one year in jail and a $2,500 fine for each of the 19 misdemeanor charges. The Kansas State Board of Healing Arts also could consider revoking Tiller's physician license if he is convicted.
Tillers' attorneys have entered a not guilty plea to the misdemeanor charges and filed a motion to dismiss the charges. In the motion, his attorneys argued that the provision requiring two or more doctors to sign off on late-term abortions is unconstitutional because it is vague, it violates a woman's right to obtain an abortion as outlined in previous court decisions, and it places an undue burden on a physician's right to practice medicine (Kaiser Daily Women's Health Policy Report, 8/7).
Court Hearing
During Friday's court hearing, the attorney general's office said the two-doctor requirement is a reasonable restriction, the AP/Globe reports (AP/Joplin Globe, 8/10). "You want a second opinion completely away from the doctor performing the abortion," Jared Maag, the attorney general's deputy solicitor general, said, adding, "It's not hard to see where the Legislature is coming from."
Morrison's office on Friday also alleged Neuhaus worked out of Tiller's clinic and that consultations were a majority of her practice, the AP/nbcactionnews reports. Attorneys for both Tiller and Neuhaus said there were not financial affiliations between the two physicians because patients paid Neuhaus, and the two doctors had separate bank accounts, according to the AP/nbcactionnews. Neuhaus' attorney Jack Focht said that just because a doctor voluntarily limits his or her practice, "That doesn't make one dependent" (Hanna, AP/nbcactionnews, 8/10).
Powell said that he would give the groups until Aug. 31 to file "friend of the court" arguments and that he likely would hold a second hearing before ruling on the law's constitutionality. Depending on Powell's ruling on the dismissal motion, a trial could proceed or be delayed until appeals of such a ruling are resolved, the AP/Globe reports (AP/Joplin Globe, 8/10).
Comments
Peter Brownlie -- CEO of Planned Parenthood of Kansas and Mid-Missouri, which operates Comprehensive Health -- said, "Somebody who was a sponsor or major backer of a law being challenged shouldn't be hearing the challenge." Troy Newman, Operation Rescue's president, said, "It's about time things start leaning toward the side of life" (AP/Joplin Globe [1], 8/10). However, Newman added that he is "not certain that the attorney general is doing everything within his power to prosecute the case. I think these are the weakest charges that could have been brought." Morrison spokesperson Frances Gorman said, "We take every case we handle very seriously," adding, "The findings of our investigation represent the full enforcement of the law" (Hanna, AP/Joplin Globe, 8/13).
"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, 17 марта 2012 г.
Miss. Lawmakers Debate Sex Education In Response To Reports Finding High Teen Birth, STI Rates
State Sen. David Jordan (D) is sponsoring a bill (S 2291) to create a pilot sex education program that would allow the state Board of Education and the state Department of Health to decide which grades would be included and how the program would be implemented. The program also would allow parents to decide whether to their children would participate. He said that abstinence "has its place but you need to talk about the consequences." According to the Department of Health, there were 432 new cases of chlamydia in young people ages 10 to 14 and 8,444 cases among youth ages 15 to 19 in 2007. There were 2,641 new cases of gonorrhea among young people ages 15 to 19 in 2007.
Comprehensive sex education opponent Rep. Philip Gunn (R) said any information beyond simple education about the reproductive process should be given by parents. He added, "By teaching kids how to have sex and telling them these techniques, they are endorsing the practice. Abstinence is the way to go" (Byrd, AP/Biloxi Sun Herald, 1/25).
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, 10 марта 2012 г.
Senate Confirms Alito As 110th Supreme Court Justice With 58-42 Vote, USA
Reaction
Sen. Dianne Feinstein (D-Calif.), who sits on the judiciary committee and supports abortion rights, said, "I am very concerned about the impact Judge Alito could have on women's rights," adding, "It is my belief that this nominee's legal philosophy and views will essentially swing the court far out of the mainstream" (Reynolds, Los Angeles Times, 2/1). Senate Judiciary Committee Chair Arlen Specter (R-Pa.), who supports abortion rights, said that Alito's nomination has prompted "a lot of anxiety" about abortion rights because the court has been closely divided on the issue, adding, "I share that anxiety." However, he said that justices sometimes change their earlier views when ruling in Supreme Court cases (USA Today, 2/1). Specter previously has said that O'Connor was "very much opposed to abortion rights before she came to the court, and she has been one of the foremost proponents of a woman's right to choose" (Kaiser Daily Women's Health Policy Report, 1/26). Bush said in a statement, "Alito is a brilliant and fair-minded judge who strictly interprets the Constitution and law and does not legislate from the bench," adding, "He is a man of deep character and integrity" (Babington, Washington Post, 2/1).
NPR's "All Things Considered" on Tuesday reported on how Alito's confirmation could shift the composition of the court and affect future cases that could come before the court, including those involving abortion rights (Totenberg, "All Things Considered," NPR, 1/31). The complete segment is available online in RealPlayer.
In addition, NPR's "All Things Considered" on Tuesday reported on senators' reactions to the confirmation, including their thoughts on how he might rule in cases involving abortion rights. The segment includes comments from Senate Minority Whip Dick Durbin (D-Ill.), Senate Majority Leader Bill Frist (R-Tenn.), and Sens. Sam Brownback (R-Kan.), Barack Obama (D-Ill.), Harry Reid (D-Nev.), Jeff Sessions (R-Ala.) and Ted Stevens (R-Alaska) (Welna, "All Things Considered," NPR, 1/31). The complete segment is available online in RealPlayer.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
суббота, 3 марта 2012 г.
FDA Approves Oral Contraceptive YAZ For Treatment Of Premenstrual Dysphoric Disorder
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Estradiol Transdermal System.
суббота, 25 февраля 2012 г.
Stimulus Bill Includes STI Prevention Funding; Removal Of Family Planning Provision Criticized
The Times reports that both chambers of Congress are "engaging in a bidding war" over who can spend more on STI prevention in the stimulus bill, and the Senate is "not to be outdone" by the House. Wesley Denton, an aide to Sen. Jim DeMint (R-SC), said, "Senate big spenders will never be underbid in wasting tax dollars," and added that he "[did not] want to know" how STI research would create jobs. The $400 million allotted in the Senate version would go to CDC "for the screening and prevention of [STIs], including HIV," according to the Times. Floor debate of the Senate bill is expected to begin next week.
Sen. Tom Harkin (D-Iowa), chair of the Senate Appropriations Subcommittee on Health, said the provision is one of the significant achievements of the bill, which also includes $870 million to prepare for a pandemic influenza outbreak and $75 million for smoking cessation. According to the Times, lawmakers from both parties have criticized these inclusions in the stimulus bill, arguing that too many of the items will not provide enough short-term relief to boost the economy. Republicans in particular have said congressional Democrats are using the bill as a medium to get approval for projects that were stalled during the Bush administration and the period when Republicans held majority in Congress (Dinan, Washington Times, 1/29).
Advocates Criticize Removal of Family Planning Funds From Stimulus
Leaders of reproductive rights groups are "upset" by President Obama's push to have lawmakers remove a provision to allow states to expand eligibility for Medicaid family planning services from the House stimulus bill, with several organizations issuing statements to criticize the move, Politico reports. The provision, which was dropped from the bill, would have allowed states to bypass the federal waiver requirement normally needed to extend Medicaid family planning benefits to women who otherwise do not qualify for Medicaid. Cecile Richards, president of the Planned Parenthood Federation of America, sent an e-mail to supporters on Wednesday calling Obama's action a "betrayal of millions of low-income women" that will "place an even greater burden on state budgets that are already strained to the breaking point." Kim Gandy, president of the National Organization for Women, said Obama "should have kept it in there, but in their political calculus they felt this was something that would pass Congress rather easily as a stand-alone measure and didn't think it was worth fighting for in the stimulus." Obama spokesperson Robert Gibbs said the president "believed that the policy of increased funding for family planning was the right one" but did not "believe that this bill was the vehicle to make that happen." Politico reports that the "political reality" is that Republicans opposed to the stimulus bill were using the family planning provision as a "too-perfect talking point ... to rally conservative opposition" to Obama's plan.
The reproductive rights leaders "stopped well short of blasting" Obama's administration over the funding removal, Politico reports. According to Politico, the groups "appear[ed] not to want to split" with Obama so early into his presidency, and leaders are "confident" that Obama will support the issues they care most about in the "long run." Gandy said, "We were definitely told that the Obama administration has a strong commitment to women's reproductive rights and family planning. This should not be seen as a lessening of that commitment, only as a change of the vehicle" (Gerstein/Lerer, Politico, 1/29).
Q&A on Family Planning Provision
Time on Thursday published a list of questions and answers about the family planning provision. The Q&A addresses what the provision would have done, whether it would have affected emergency contraception or abortion and how the provision would have saved money in the long run, among other topics (Sullivan, Time, 1/29).
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, 18 февраля 2012 г.
March Of Dimes Announces Prematurity Campaign Expansion At Surgeon General's Conference
"The March of Dimes Prematurity Campaign has stimulated attention and action around the problem of premature birth, and this Surgeon General's Conference puts preterm birth on the national health care agenda," said Jennifer L. Howse, president of the March of Dimes. "As we refine our strategies and renew our commitment through our expanded campaign, we are confident we will continue to find solutions and improve the health of babies at home and globally."
A key element of the expanded campaign will be an annual report card that will grade the nation and each state on its preterm birth rate. The grade will be determined by comparing the preterm birth rate of the state and the nation to the Healthy People 2010 goal. The report card also will focus on key contributing factors to preterm birth, including federal and state policies related to improving access to health coverage for women of childbearing age and children. The first report card will be issued November 12, 2008, as part of March of Dimes Prematurity Awareness Day events.
More information about the campaign can be found at marchofdimes/prematurity.
The goal of the March of Dimes Prematurity Campaign, launched in 2003, is to reduce the U.S. preterm birth rate by 15 percent. The expanded campaign is expected to address three critical areas:
1. Accelerated funding for basic research in the United States and globally and to translate the findings into practices that will benefit women of childbearing age.
2. Expansion of direct services to NICU families to provide them with information - in English and Spanish - about what to expect in the NICU, a glossary of common medical terminology and conditions, and tested suggestions about how to parent in a NICU.
3. The creation of Community Intervention Programs, such as March of Dimes Healthy Babies are Worth the Wait®, which focuses attention on the challenges posed by late preterm deliveries.
The campaign's global strategy will include the first report on the scope and toll of premature birth worldwide as well as increased collaboration with scientists worldwide to accelerate progress.
Preterm birth (defined as birth before 37 completed weeks gestation) is a serious and costly health problem and is the leading cause of death in the first month of life. More than half a million babies - one out of every eight - are born too soon each year in the United States, a 20 percent increase since 1990. And, unfortunately, new statistics released last week by the National Center for Health Statistics showed only a slight decline in the nation's overall infant mortality rate or in the proportion of infants who died as a result of an early birth.
Babies who survive an early birth face serious lifelong health problems, including learning disabilities, cerebral palsy, blindness, hearing loss and other chronic conditions, including asthma. Even infants born just a few weeks too soon - known as late preterm birth - have a greater risk for respiratory distress syndrome (RDS), feeding difficulties, temperature instability (hypothermia), jaundice, delayed brain development and death.
The conference, convened by Acting Surgeon General Steven K. Galson, MD, MPH, RADM, USPHS, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is being held June 16 and 17 in Rockville, Md.. Experts at the conference will generate an action agenda that will be used to guide the March of Dimes in advocating for expanded federal support for research, education and pilot testing of strategies to prevent preterm birth.
The March of Dimes is the leading nonprofit organization for pregnancy and baby health. With chapters nationwide and its premier event, March for Babies, the March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For the latest resources and information, visit marchofdimes/ or nacersano/.
Source: Michele Kling
March of Dimes Foundation
суббота, 11 февраля 2012 г.
Cognitive Function Is Superior In Breast Cancer Patients Treated With Letrozole Versus Tamoxifen
The trial, which enrolled postmenopausal women surgically treated for early-stage, hormone-responsive breast cancer, found that letrozole was more effective at preventing recurrent disease (especially distant metastases) than tamoxifen.
Karen E. Ribi, PhD, with the International Breast Cancer Study Group in Bern, Switzerland, and her colleagues had theorized that because of the estrogen deprivation associated with aromatase inhibitors, patients who have received letrozole will have worse cognitive function than tamoxifen-treated patients.
"While cognitive function is recognized as a potential long-term side effect of adjuvant chemotherapy for breast cancer treatment, few studies have looked at the effect of adjuvant endocrine therapy on cognition," Dr. Ribi noted in her presentation. "What's more, those studies that have examined the effect of adjuvant endocrine therapy on cognition have produced conflicting results."
The primary endpoint of the sub-study was the composite score calculated from seven cognitive tasks. These included detection, identification, learning, memory, monitoring, shopping list, and shopping list delayed recall.
The analysis included 120 women enrolled in an institution with at least ten patients recruited to the parent protocol. All women had been in the trial for fewer than five years and were still taking their assigned endocrine treatment. None had developed recurrent breast cancer or a second malignancy.
Results showed that that while both groups had scores below age-standardized standardized norms of the CogState tasks, patients taking letrozole during the last three of five years of treatment had better cognitive function than those taking tamoxifen.
Dr. Ribi cautioned that potential study limitations include the lack of a true baseline assessment prior to the start of endocrine therapy and the lack of a longitudinal design to evaluate changes during treatment. Also, the sub-study's low accrual resulted in a revised analysis plan.
Finally, she said that future trials will evaluate the change in cognitive function from five years on endocrine treatment to one year after the completion of treatment. Plans are also underway to examine the impact of endocrine treatment on cognitive function in premenopausal women from baseline to one year on treatment.
Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail
суббота, 4 февраля 2012 г.
Calcium may protect women from cancer
A University of Minnesota Cancer Center study found that women consuming more than 800 milligrams of calcium each day reduced
their risk of colorectal cancer by as much as 26 to 46 percent. A 26 percent reduction in risk of colorectal cancer occurred
regardless of whether the calcium intake was from diet or supplement. Among women who consumed high levels of calcium from
both diet and supplements, the risk reduction was almost double that observed for calcium from either source by itself.
The results of the study appear in this month's Cancer Epidemiology, Biomarkers and Prevention journal. Andrew Flood, Ph.D.,
epidemiologist with the University of Minnesota Cancer Center and School of Public Health, led the study in collaboration
with the National Cancer Institute (NCI).
The study involved 45,354 women in the United States who did not have a history of colorectal cancer. The women were
categorized into groups according to information they provided about their diets and lifestyles. The women averaged 61.9
years of age upon entering the study and they were followed in the study for an average of 8.5 years. This study began in
1987 and closed in 1997. During that time, 482 women in the study developed colorectal cancer.
"It is especially notable that the risk reduction was present regardless of the source of the calcium, and that
simultaneously consuming high levels of calcium from both diet and supplements further reduced risk," Flood said. "These
observations suggest that it was the calcium per se, and not merely dairy products or some other variable that accounted for
the reduction in risk."
The findings provide further evidence in a growing body of research that indicates a link between calcium and prevention of
colorectal cancer. This study is good news for women because they comprise about half of the approximately 150,000 people in
the United States diagnosed annually with colorectal cancer. The cancer ranks as the second leading cause of cancer death,
and the risk of contracting it increases with age.
Flood notes that more research needs to be done to understand why and how calcium provides protection against colorectal
cancer in some women.
"We really don't know at this point," Flood said. "There are currently two main theories. One is that calcium has the ability
to neutralize secondary bile acids that are produced during the digestion of fat and are highly irritating to the cells in
the lining of the colon. The evidence in support of this theory is not very strong.
"An alternate theory is that calcium has a direct impact on a whole series of biochemical pathways within the cells that line
the colon and rectum. These pathways play important roles in regulating how these cells grow and mature and thus, can be
important components of the cancer process."
To put the study results in perspective, Flood says consuming a diet rich in calcium - one that provides at least 800 mg per
day, which is actually lower than the current recommended daily allowance of 1,200 mg per day--is a safe and effective way
for women to help guard themselves against colorectal cancer.
As for the benefit of calcium for men, he said, "The results of this study are consistent with other studies that show
calcium reduces risk of colorectal cancer in both women and men. A note of caution for men, however, is that dairy foods, the
primary source of calcium in the U.S. diet, have been linked in some studies to increased risk of prostate cancer."
More about the study
The 45,354 women in this study were selected from the Breast Cancer Detection Demonstration Project (BCDDP), which was a
breast cancer screening program conducted jointly by NCI and the American Cancer Society between 1973-1980.
The women initially completed a 62-item questionnaire that assessed their usual daily diet, lifestyle habits and patterns,
and use of over-the-counter nonsteroidal anti-inflammatory medicines. A separate series of questions asked about their intake
of calcium from supplements, whether multivitamins or calcium-specific.
The information received was used to categorize the women into five equally sized groups. The groups were ranked in order of
increasing calcium intake, based on the dietary practices the women reported at the start of the study.
-- Women in the lowest group consumed less than 412.3 mg of calcium from diet each day.
-- Compared to the low-consuming group, women in the four higher groups (412.4-528.9 mg/d; 529.0-656.2 mg/d; 656.3-830.9
mg/d; and greater than 830.9 mg/d) all showed reduced risk of developing colorectal cancer over the course of the study.
-- Women in the highest group of dietary calcium intake - greater than 830 mg/d - had a 26 percent lower risk of developing
colorectal cancer compared to women in the lowest group.
The women also were divided into groups based on their intake of calcium from supplements. Women who reported consuming 800
mg/d of calcium from supplements had a 24 percent lower risk of developing colorectal cancer than women who took no calcium
from supplements. The researchers further found that high intake of calcium from both diet and supplements reduced risk even
more than calcium from either source alone. Women who consumed more than 412.4 mg/d of calcium from diet and also consumed
more than 800 mg/d from supplements had a 46 percent lower risk of colorectal cancer than women who consumed less than 412
mg/d from diet and less than 800 mg/d from supplements.
This study was funded by NCI. In addition to Andrew Flood, researchers on the study were Ulrike Peters, Fred Hutchinson
Cancer Center, Seattle; and Nilanjan Chatterjee, James Lacy, Jr., Catherine Schairer and Arthur Schatzkin, all with NCI in
Bethesda, MD
The Cancer Center at the University of Minnesota is a National Cancer Institute-designated Comprehensive Cancer Center.
Awarded more than $80 million in peer-reviewed grants during fiscal year 2003, the Cancer Center conducts cancer research
that advances knowledge and enhances care. The center also engages community outreach and public education efforts addressing
cancer. To learn more about cancer, visit the University of Minnesota Cancer Center Web site at cancer.umn.edu. For cancer questions, call the Cancer Center
information line at 1-888-CANCER MN (1-888-226-2376) or 612-624-2620 in the metro area.
Mary Lawson - mlawsonumn.edu
University of Minnesota
суббота, 28 января 2012 г.
Very Common Condition In Women That Often Goes Undiagnosed Now Identifiable By Medical Imaging Technique
Pelvic organ prolapse is relatively common and occurs when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs. If left untreated, living with prolapse can be a challenge, both physically and emotionally, as the symptoms can disrupt day-to-day life. Dynamic MRI is performed while the patient performs a straining maneuver, such as bearing down. Static MRI is performed while the patient is at rest.
The study, performed at NYU Langone Medical Center in New York, included 84 women with lower urinary tract symptoms who underwent dynamic and static MRI scans for a suspected urethra abnormality. Ten of the 84 patients were found to have an abnormality of the urethra. "However 33 patients were diagnosed with pelvic organ prolapse, of whom 29 were diagnosed exclusively on dynamic imaging," said Genevieve L. Bennett, M.D., assistant professor of radiology at NYU Langone Medical Center and lead author of the study.
"Dynamic imaging allows for the detection of pelvic organ prolapse, which may not be evident at rest but only detected when the woman strains," said Bennett.
"The results of our study show that in women with lower urinary tract symptoms who undergo MRI for evaluation of a suspected urethra abnormality, the addition of dynamic MRI permits detection of pelvic organ prolapse that may not be evident on static at rest images and that may also go undetected at physical examination," she said.
Source: Heather Curry
American College of Radiology / American Roentgen Ray Society
суббота, 21 января 2012 г.
Pennsylvania Legislator Seeks 'Middle Ground' On Emergency Contraception Bill
"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, 14 января 2012 г.
Opinion Pieces Examine Conservative 'Feminism'
~ Nancy Cohen, Los Angeles Times: Palin said in her speech that recent polls show "more Americans proudly proclaiming themselves as pro-life." According to historian and author Cohen, although Palin is "not entirely wrong, ... that doesn't mean she's right." Cohen writes that "this new conventional wisdom ... stems from misleading media reporting abetted by partisan hype." She adds that "the three polls on which the so-called trend in public opinion is based include one outlier and two with inconclusive results," making the "complete picture ... nuanced." According to Cohen, "A majority of Americans do not want to see abortion criminalized, but the nation is evenly divided between those who call themselves pro-life and those who call themselves pro-choice." However, the antiabortion-rights movement "seems to be winning the framing war with its 'pro-life' label," as "'pro-choice' has turned into a tone-deaf rallying cry," she continues. The phrase "pro-choice" is "inadequate to our actual policy preferences and to the philosophical values Americans hold on the subject of abortion," Cohen writes. She adds, "It essentially cedes the moral high ground to the antiabortion movement" and "doesn't do enough to communicate ... the belief that, in a free and democratic nation, the decision to have a child should rest with the individual woman and those with whom she freely consults." Cohen continues, "Perhaps 'pro-choice' was once good enough shorthand for liberty, human dignity, individualism, pluralism, self-government and women's equality," but "anyone who thinks it is still self-sufficient ... hasn't been paying attention" (Cohen, Los Angeles Times, 5/29).
~ Jessica Valenti, Washington Post: Palin's recent adoption of the term "feminist" is "not a realization of the importance of women's rights" but "part of a larger conservative move to woo women," Valenti, an author and founder of the blog Feministing, writes. "Just as consumer culture tries to sell 'Girls Gone Wild'-style sexism as 'empowerment,' conservatives are trying to sell anti-women policies shrouded in pro-women rhetoric," Valenti continues. She adds, "But, of course, Palin isn't a feminist -- not in the slightest." Valenti writes that what Palin calls "the emerging conservative feminist identity" is actually "an empty rallying call to women who are disdainful of or apathetic to women's rights, who want to make abortion and emergency contraception illegal, who would cut funding to the Violence Against Women Act and who fight same-sex marriage rights." Palin's "'feminism' isn't just co-opting the language of the feminist movement, it's deliberately misrepresenting real feminism to distract from the fact that she supports policies that limit women's rights," Valenti writes. Palin's brand of feminism is "a manipulated buzzword being used to garner support for a party that time and time again votes against women's rights," she continues, adding that "feminists -- or anyone who cares about women's progress -- need to stop Palin from turning feminism into yet another empty slogan" (Valenti, Washington Post, 5/30).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
суббота, 7 января 2012 г.
Puberty Timing And Body Fat In Women Linked By Genes
Menarche, the onset of first menstruation in girls, indicates the attainment of reproductive capacity and is a widely used marker of pubertal timing. Age of menarche varies widely and is highly dependent on nutritional status. Early menarche is associated with many adverse health outcomes later in life, including breast cancer, endometrial cancer, obesity, type 2 diabetes and cardiovascular disease, as well as shorter adult stature.
To identify loci for age at menarche, the researchers performed a meta-analysis of 32 genome-wide association studies on more than 87,000 women from the U.S., Europe and Australia and performed replication studies in nearly 15,000 additional women. In addition to the known loci at LIN28B and 9q31.2, the researchers identified 30 new menarche loci and found suggestive evidence for a further 10 loci. According to the researchers, the new loci included four previously associated with body mass index, three in or near other genes implicated in energy homeostasis and three in or near genes implicated in hormonal regulation. Ingenuity and gene-set enrichment pathway analyses identified coenzyme A and fatty acid biosynthesis as biological processes related to timing of menarche.
"Our study found genes involved in hormone regulation, cell development and other biological pathways associated with mechanisms age at menarche, which shows that the timing of puberty is controlled by a complex range of biological processes," said senior author Joanne Murabito, MD ScM, an associate professor of medicine at BUSM and Clinic Director and Investigator of the Framingham Heart Study.
"Several of the genes for menarche have been associated with body weight and obesity in other studies suggesting some women may have a genetic susceptibility to weight gain and early puberty. It is important to understand that these 'genetic factors' can be modified by changes in lifestyle. Efforts to reduce or prevent childhood obesity should in turn help reduce the early onset of puberty in girls," added Murabito.
The next steps according to the researchers are to examine the findings in women of other race/ethnic groups, as well as to examine whether these genetic loci influence growth and to determine whether the associations are driven by measures of body fatness. This future work will help to unravel the biologic mechanism underlying the associations.
The researchers are extremely grateful to all study participants including women participating in the Framingham Heart Study for making this research possible. The investigators would also like to acknowledge the support provided by the National Institute on Aging and the National Heart, Lung and Blood Institute.
Source:
Gina DiGravio
Boston University Medical Center