Specialty clinics that provide family planning services in Texas have seen a significant decrease in state funding over the past four years because lawmakers have redirected millions of dollars to expand family planning at community health centers, the Dallas Morning News reports. The funding changes began in 2005, when lawmakers said they were shifting funding to community health centers because they offered more comprehensive health care to low-income patients. Advocates for the family planning clinics argue that the policy is an attempt by antiabortion-rights advocates to shut the clinics down. Although clinics that receive state funding are prohibited from offering abortion services, some conservative lawmakers believe that limiting the funding will hurt groups like Planned Parenthood, which offers abortion services at other locations, according to some family planning advocates. The Morning News reports that state lawmakers might return some of the funding to the specialty clinics during the current legislative session; however, the funding only would equal any money left unused by the 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, 28 апреля 2012 г.
суббота, 21 апреля 2012 г.
Mexico City Legislature Approves Bill That Legalizes Abortion During First Three Months' Gestation
The Mexico City Legislature on Tuesday voted 46-19 to approve a bill that would allow pregnant women to obtain a legal abortion during the first three months' gestation, the New York Times reports (McKinley, New York Times, 4/25). Mexico City Mayor Marcelo Ebrard of the Party of the Democratic Revolution has promised to sign the bill into law, the Los Angeles Times reports (Tobar, Los Angeles Times, 4/25). Under current Mexican law, abortion only is permitted if the life of the pregnant woman is endangered or if the woman has been raped. Lawmakers from the Democratic Revolutionary Party in March proposed the measure. Abortion-rights opponents in the city recently collected the 36,000 signatures necessary to ask the city Legislature for a referendum on abortion if the bill becomes law; however, a referendum is nonbinding on lawmakers (Kaiser Daily Women's Health Policy Report, 4/24). The antiabortion group Catholic Lawyers has said that the Legislature violated the constitution and city laws by ignoring the petition for a referendum on the issue, the New York Times reports (New York Times, 4/25). Mexican Sen. Santiago Creel of the National Action Party said the party will seek to overturn the measure on the grounds that the country's constitution guarantees the right to life (Kaiser Daily Women's Health Policy Report, 4/24). Cuba and Guyana are the only countries in the region that allow legal abortions for all women (Hawley, USA Today, 4/25).
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
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced additional positive safety and efficacy results from its Phase IIb clinical trial known as the Petal Study (603 study) using its proprietary, orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. The Petal Study enrolled 252 patients, with a confirmed diagnosis of endometriosis, into three treatment groups; elagolix 150 mg once daily, elagolix 75 mg twice daily, or depo-subQ provera 104(TM) (DMPA) for six months of treatment followed by six months of no treatment. Database lock and unblinding of the full 48 week data set has provided more insight on the clinical benefits and safety profile of elagolix for the treatment of pain associated with endometriosis.
"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.
"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
The San Francisco Chronicle on Sunday examined the differences between California and the Bush administration on sex education for middle and high school students (Weiss, San Francisco Chronicle, 2/11). The Title V abstinence education grant program, administered by HHS' Administration for Children and Families, distributes funds to states based on a formula favoring states with more low-income children. To receive Title V funds, states must adhere to requirements, including barring teachers from discussing contraception and requiring teachers to say that sex within marriage is "the expected standard of sexual activity." California, Maine, New Jersey and Pennsylvania have rejected the grants (Kaiser Daily Women's Health Policy Report, 10/31/06). A study conducted by Laura Duberstein Lindberg and colleagues at the Guttmacher Institute published in the December 2006 issue of Perspectives on Sexual and Reproductive Health found that because of changing trends in federal funding from 1995 to 2002 teenagers nationwide were "significantly more likely to have received instruction about how to say no to sex than ... birth control methods." California school districts are required to teach HIV/AIDS prevention, and state guidelines require that districts provide medically accurate information about contraception, while also "emphasizing that abstinence is the only sure method to avoid pregnancy," the Chronicle reports. Angela Griffiths, executive director of the Hayward, Calif.-based abstinence-only program Await and Find, said California is turning down $7 million annually that could be used to reach more young people, adding that she believes that the Guttmacher study's conclusions about the effectiveness of abstinence-only programs are "incorrect." Hilary McLean, press secretary for California schools chief Jack O'Connell, said the state has "made it clear where we stand," adding, "And yet the Bush administration and the state are still debating this." According to the Chronicle, more than $1 billion in federal funding has been provided for abstinence-only sex education programs in the past 10 years, and the Bush administration has budgeted $241.5 million for abstinence-only programs in 2007 (Weiss, San Francisco Chronicle, 2/11).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Подписаться на:
Комментарии (Atom)