Blogs Comment On Health Care Reform, Protests To Afghan 'Rape Law,' Obama Nominees, Other Topics

The following summarizes selected women's health-related blog entries.

~ "What's At Stake for Women in Health Care Reform," Marcia Greenberger, Huffington Post blogs: All women in the U.S. "should have a guarantee of high quality, affordable" health care coverage, Greenberger, co-president of the National Women's Law Center, writes. "Health care reform that results in accessible care for women means making sure that everyone has access to affordable coverage and health care, and ending unfair insurance practices," she writes. "To meet the needs of women, health care reform must result in coverage that is affordable -- meaning that it must include income-based subsidies for health care premiums and all out-of-pocket expenses; elimination of annual or lifetime caps on services and prescriptions; and a strengthened and expanded Medicaid program," Greenberger continues, adding that reform must also "provide comprehensive health and prescription drug benefits with coverage for a full range of health services, including wellness, prevention and reproductive health services." Greenberger concludes that "millions of Americans simply can't afford to wait for meaningful reform that will bring a guarantee of quality, affordable comprehensive health care for us all" (Greenberger, Huffington Post blogs, 4/16).

~"Three Cheers for Afghan Women," Nicholas Kristof, New York Times' "On the Ground": Kristof writes that he is "awed by the courage of those 300 Afghan women who endured stones, jeers and threats" in the country's capital, Kabul, to protest a new law that applies only to Shiites and "obliges women to sleep with their husbands on demand." Kristof adds that he "can't imagine the guts it would take to be a [minority] woman walking with a banner demanding equal rights through an enraged mob of stone-throwing, spitting fundamentalists." Although Kristof writes that he is "enormously impressed by the courage of these women," he adds that he "do[es] worry about a backlash," as Afghans are "very nationalistic" and the protesters "were denounced as pawns of Christians and foreigners." He concludes that Afghanistan "can't develop economically and achieve stability so long as girls are kept home and women are mostly barred from the work force" (Kristof, "On the Ground," New York Times, 4/15).

~ "Don't Give the Right Wing a Win on Obama's Nominees," Nancy Keenan, Huffington Post blogs: "The blogosphere is abuzz with stories of GOP obstructionism of some of President Obama's nominees to crucial posts," Keenan writes, adding, "Random and ridiculous reasons have been given for various nominees," particularly judicial nominee David Hamilton; assistant attorney general for the Office of Legal Council nominee Dawn Johnsen; and HHS secretary nominee Kansas Gov. Kathleen Sebelius (D). Keenan continues that antiabortion-rights advocates are "attacking" these three nominees "simply because they've taken pro-choice positions," adding that the antiabortion-rights advocates are "engag[ing] in an all out effort to use anti-choice rhetoric and the threat of a filibuster." She writes, "If they succeed, they will be emboldened to shred the credibility of future nominees simply to appease their right-wing base." Keenan asks, "[C]ould it be that anti-choice activists are opposing someone solely based on pro-choice positions?" She concludes, "The right wing has made these nominees their test case on how to derail President Obama's efforts to put qualified persons in key posts," adding that groups like NARAL Pro-Choice America aim to "make sure they fail this test" (Keenan, Huffington Post blogs, 4/16).














~ "Zero Tolerance for Maternal Mortality," Abdelhadi Eltahir, RH Reality Check: "Maternal and newborn care is one of the biggest challenges in international health," and it is "unacceptable -- and in many ways shameful -- for the international health and development community" to allow preventable illnesses to cause maternal deaths, Eltahir -- senior maternal and newborn care adviser at Pathfinder International -- writes in a blog entry. According to Eltahir, the "availability of emergency blood is not commonly practiced in the developing world -- and sub-Saharan Africa in particular -- due to cultural, physical and/or resource barriers." He continues, "But with the right systems and training, many of these barriers are addressed and emergency blood made available." Eltahir writes that it is "imperative that we rededicate ourselves to ending maternal mortality." He notes that "ensuring maternal and newborn survival" calls for "broad ranging and innovative approaches," including increasing access to family planning, "managing emergency obstetric care and involving communities in identifying and addressing their own community health needs." He writes that along with more attention and funding directed toward "quality health services," increased pressure on leaders is needed "to highlight this as a major issue going forward." He concludes, "I look forward to a new time of zero tolerance and more women being saved through such simple, yet vital, acts as accessible blood" (Eltahir, RH Reality Check, 4/16).

~ "Teens and Sex Education at the Doctor's Office," Deborah Kotz, U.S. News & World Report's On Women: Some parents whose children receive abstinence-only sex education at schools are beginning to "rely on a gynecologist to answer the kinds of questions about sex that their daughters may not feel comfortable asking or that they themselves may not know the answers to," Kotz writes, citing a recent Houston Chronicle article about Texas parents who are using gynecologists to help educate their teenage daughters. Kotz writes that "[u]sing a trusted gynecologist, preferably one who specializes in adolescent medicine, as a resource for health information is probably a wise choice, given the other sex-education options teens are turning to." She continues that teens' friends "can be a wealth of misinformation," as can many Web sites. Kotz discusses the findings of a study from Lucile Packard Children's Hospital that found that many popular sexual health Web sites for teens include information "often fraught with errors and omissions," including insufficient or inaccurate information about purchasing emergency contraception, side effects from birth control pills, safety of intrauterine devices and when to begin Pap smears (Kotz, U .S. News & World Report's On Women, 4/15).

~ "Rape Law in Afghanistan Goes Down," Taylor Marsh, Huffington Post blogs: "The Shiite feminists in Afghanistan won this one for themselves" when they "took to the streets" and "stood up amidst a mob of men ... to stand up for their rights," Marsh, political analyst and commentator, writes in a blog entry about reports on CNN that Afghan President Hamid Karzai plans to change a recent law that critics say legalizes rape within Shiite marriages. According to Marsh, the law spurred an "outcry raucous from across the globe," including a statement from President Obama that legalized rape is "abhorrent" and similar concerns from Secretary of State Hillary Rodham Clinton. However, Marsh writes, "nothing could have made a bigger difference than the women standing up for themselves, 300 to 500, taking to the streets protesting their life as property." She continues that the women's protests, "manifested in President Karzai changing the law, makes their actions the stuff of heroes" (Marsh, Huffington Post blogs, 4/16).


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.

Ortho Biotech Announces NDA Submission For Trabectedin For The Treatment Of Relapsed Ovarian Cancer

Ortho Biotech Products, L.P. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection)for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL will provide a new, non-platinum treatment option for these patients in the United States.


The application follows the completion of a multicenter, randomized Phase III study, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination of trabectedin and DOXIL to DOXIL alone in 672 patients. The study showed that patients treated with the combination treatment had a statistically significant improvement in the primary endpoint of progression-free survival (PFS, or the length of time during and after treatment in which the disease does not progress) compared to patients treated with DOXIL alone.


"This is a significant milestone in the development of trabectedin, an agent with a novel mechanism of action that holds promise for patients with relapsed ovarian cancer," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. "We are confident in the strength of the data supporting the application and look forward to working with the FDA throughout the regulatory review process."


Relapsed ovarian cancer refers to epithelial carcinoma of the ovary that recurs after treatment. According to the National Cancer Institute (NCI), it is estimated that 21,650 women will be diagnosed with, and 15,520 women will die from ovarian cancer in the U.S. in 2008.


Trabectedin is being developed under a license from PharmaMar, and DOXIL is marketed by Ortho Biotech Products, L.P. in the U.S.


About the ET743-OVA-301 Study


Patients were enrolled at 124 centers in 21 countries. Per the study protocol, the data were evaluated by a blinded, independent radiology review and a blinded, independent oncology review. The trabectedin/DOXIL combination demonstrated a statistically significant improvement in PFS compared to DOXIL alone (median PFS 7.3 versus 5.8 months, respectively) and a statistically significant reduction of 21% in the risk of progression or death during the observation period in the independent review of patients with radiologically measurable disease (HR=0.79, 95% CI (0.65;0.96), p=0.0190). This result is consistent with the results of the independent oncology review that takes into account clinical as well as imaging data in the assessment of progression. In this review, there was a 28% risk reduction for disease progression or death with the trabectedin/DOXIL combination (HR=0.72, 95% CI (0.60; 0.88), p=0.0008).















Secondary endpoints included response rate, overall survival, and safety. A statistically significant increase in response rate was seen with the trabectedin and DOXIL combination (28%) compared to DOXIL alone (19%), as measured by the independent radiology review. A final protocol-specified survival analysis is planned after the occurrence of 520 events. The safety profile in the study was consistent with previous experience with trabectedin and DOXIL.


The most common adverse reactions (greater than or equal to 20%) for the trabectedin/DOXIL combination compared to DOXIL alone, respectively, were:



-- Hematological reactions including neutropenia (77% versus 38%, with febrile neutropenia occurring in 8% of the cases and sepsis in 1% of the cases), leucopenia (48% versus 26%), anemia (48% versus 25%) and thrombocytopenia (36% versus 8%);



-- Gastrointestinal reactions including nausea (74% versus 42%), vomiting (56% versus 30%) and diarrhea (26% versus 19%);



-- Liver enzyme (transaminase) elevations were more common in the combination arm, but were generally reversible and not associated with evidence of chronic liver damage or other clinical consequences. These included increased alanine aminotransferase (55% versus 9%) and increased aspartate aminotransferase (40% versus 10%); and



-- Fatigue (46% versus 36%).


Additionally, commonly associated DOXIL adverse events, such as hand-foot syndrome (HFS) and stomatitis, occurred in fewer patients receiving the combination compared to DOXIL alone (24% versus 54% and 20% versus 33%, respectively).


About Trabectedin


Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the Caribbean tunicate, Ecteinascidia turbinate ("sea squirt"). The compound is now produced synthetically. Trabectedin binds to the minor groove of DNA, interfering with cell division and genetic transcription processes and DNA repair machinery. Trabectedin is currently in Phase III development in ovarian cancer and to expand its uses in sarcoma.


According to the licensing agreement, PharmaMar has rights to market the compound in Europe and Japan, while Ortho Biotech Products, L.P. has marketing rights for the product in the rest of the world.


About Ortho Biotech Products, L.P.


Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit orthobiotech.


Ortho Biotech Products, L.P. is a member of the Johnson & Johnson Family of Companies.


Forward-Looking Statement


This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at sec, jnj or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.


Ortho Biotech Products, L.P.

orthobiotech



View drug information on Doxil.

Women Over 50 Live In Fear Of Violence, Study Finds

Forget fearing old age, it seems as women grow older those on lower incomes are more likely to fear the threat of violence, a Queensland University of Technology nationwide study has found.



The Australian Active Ageing (Triple A) Study has shown women need and want to protect themselves against violence as they get older.



QUT Associate Professor Jan Lovie-Kitchin, from the Faculty of Health, said the study looked at older women's perceptions of vulnerability and their expressed need to learn to protect themselves against violence.



"It is clear that as women grow into the older years, they experience increased feelings of vulnerability," Professor Lovie-Kitchin said. "They need information and want opportunities to learn about ways to protect themselves against violence."



Professor Lovie-Kitchin said being able to live free of fear and with the confidence to participate in social life beyond the home was an important part of improving the quality of life for older women.



"Fear of violence needs to be recognised as a barrier to older people's social connectedness and the health and wellbeing of older women specifically."



Professor Lovie-Kitchin said women on lower incomes reported feeling vulnerable when managing their money, accessing transport, and ensuring their homes were safe and secure.



"Older women might experience feelings of exposure to danger because of their smaller size and lesser strength," she said. "But they could also feel vulnerable because of their limited finances and lack of knowledge which might force them to depend on people they don't necessarily trust.



She said some ideas to alleviate women's perceptions of risk and fears of violence included providing education and information about money management, access to safe transport, and assistance with home security and safety."



"There also needs to be recognition of the influence of media in generating feelings of exposure to danger due to age," she said.



"Sensationalised crimes in the media are often the only form of contact with the outside environment for many older and isolated people, and can heighten their sense of defencelessness.



"While the media may negatively impact on older women's perceptions of violence, it also has the capacity to educate and inform about protective measures for older women."






The Triple A Study, which is being undertaken in collaboration with the National Seniors, involved 2620 adults aged 50 years and over, and looked at how different elements of a person's life contribute to active ageing.



Contact: Sandra Hutchinson


Queensland University of Technology

Microbicide Films For HIV Prevention To Be Developed By Pitt

With the support of an $11.8 million, five-year federal grant, researchers at the University of Pittsburgh and their collaborators are developing a quick-dissolving vaginal film containing a powerful drug that reduces the risk of HIV infection, and they plan to begin testing it locally within a year.



A small film, like those used to deliver breath fresheners, could have several advantages over vaginal microbicide gels that are already being tested overseas, said Sharon Hillier, Ph.D., professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine, senior investigator at Magee-Womens Research Institute (MWRI), and co-principal investigator of the new project, which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.



"Multiple films could be packaged in discrete cartridges without the need for refrigeration, making them portable and easier to store and distribute, and therefore probably cheaper than a gel," she noted. "And, because they aren't likely to be as messy as a gel, women might be willing to use them routinely, perhaps on a daily basis."



Led by co-principal investigator Lisa Cencia Rohan, Ph.D., associate professor, University of Pittsburgh School of Pharmacy, and MWRI associate investigator, the researchers will first develop a film version of the anti-retroviral drug tenofovir and establish the necessary processes to make it on a large scale for human use. Tenofovir in its pill form is used as an HIV treatment, and South African researchers recently showed that a gel formulation of the drug cut the risk of HIV infection by more than half among women who were most conscientious about applying it before and after intercourse; the gel reduced the infection risk by 39 percent among women who were less vigilant.



The film would provide an alternative dosage form that preclinical testing suggests can release the drug faster and more efficiently than the gel version.



"An effective microbicide strategy should include different forms of the product," Dr. Rohan said. "Women will have preferences, and having options to meet those needs will lead to greater use and therefore better protection from infection."



In addition to tenofovir, the researchers will develop and test a second film containing another anti-HIV agent that has yet to be determined.



Project collaborators include Bernard J. Moncla, Ph.D., and Charlene Dezzutti, Ph.D., both of Pitt and MWRI; researchers from the University of Washington; the New York State Institute for Basic Research; Johns Hopkins University; and CONRAD.



Source:

Anita Srikameswaran

University of Pittsburgh Schools of the Health Sciences