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Advocates Express Concern About Embryonic Stem Cell Research Guidelines As Comment Period Closes
Supporters of embryonic stem cell research have expressed concern about the impact on existing research efforts under the Obama administration"s draft guidelines outlining criteria for federal funding of stem cell research, the Washington Post reports. The public comment period for the guidelines ends Tuesday and has generated more than 20,000 comments addressing nearly every element of the proposal. The guidelines, which NIH issued in April, propose limiting federal funding for the research to stem cells derived from unused embryos created for fertility treatments and willingly donated by patients who have given written consent. Former President George W. Bush in August 2001 enacted restrictions limiting federal funding for the research to the 21 stem cell lines existing at the time. Although President Obama in March signed an executive order lifting Bush"s restrictions, some proponents of embryonic stem cell research have suggested that Obama"s plan could actually jeopardize many existing research efforts. The Obama administration is expected to issue its final version of the guidelines by July 7, the Post reports.After Bush restricted federal funding to the embryonic stem cell lines already in existence, many researchers turned to private donors and state governments for the financial support to create hundreds of new lines. Although supporters of the research initially were pleased that the Obama administration"s guidelines would allow federal funding for research on these new existing lines, some are now concerned that certain stipulations in the new guidelines could actually disqualify these research efforts from receiving federal funding. For example, NIH"s proposal requires that couples who wish to donate unused embryos for research sign a consent form indicating that they were fully informed of their alternatives. Although many fertility clinics provide information for couples about their other options, few clinics note these details in written consent forms, according to the Post. Therefore, existing stem cell lines derived from embryos donated by couples who did not sign the required consent forms could be ineligible under NIH"s draft proposal, the Post reports. In addition, many stem cell research supporters also expressed disappointment that only unused embryos created for fertility treatments would be eligible for federal funding.George Daley of the Harvard Stem Cell Institute said that the Obama administration"s guidelines "take 2009 standards and attempt to apply them retroactively, which isn"t really a standard that would allow most of the pre-existing lines to be acceptable for NIH funding." Lawrence Goldstein, director of the University of California-San Diego"s stem cell program, said, "It"s not that past practices were shoddy. But they don"t necessarily meet every letter of the new guidelines moving forward." Goldstein added that researchers would "have to throw everything out and start all over again" under the new proposed guidelines. Amy Comstock Rick, CEO of the Coalition for the Advancement of Medical Research, said that her group is "very concerned" about the funding prospects for existing research efforts, adding that if NIH officials do not modify the guidelines, "very little current research would be eligible" to receive federal funds. However, Raynard Kington, acting NIH director, said the agency is aware of the concerns and "will take them into consideration." He added that "it"s unambiguous that the intent of the president was to expand opportunities and research in this area," as long as such research is "scientifically worthy" and "ethically responsible" (Stein, Washington Post, 5/25).

Arizona, North Carolina Legislatures Take Action On Abortion, Sex Education Measures
The following summarizes news coverage on women"s health-related legislation in Arizona and North Carolina. ~ Arizona: The Arizona Senate Public Safety and Human Services Committee on Wednesday voted 4-3 to approve a bill (S.B. 1206) that would place several restrictions on abortion rights and allow pharmacists or other health care providers to refuse to distribute emergency contraception based on religious or moral objections, the AP/Arizona Daily Star reports. The state House passed an identical bill in March. The measure would impose a 24-hour waiting period for women seeking abortion procedures and mandate that doctors inform women about risks and alternatives. It also would toughen an exisiting parental consent requirement for minors seeking abortion. The bill requires an in-person consultation before the 24-hour waiting period, which would increase costs for women who are forced to travel to a clinic twice, according to Planned Parenthood of Arizona President Bryan Howard. The Legislature approved bills with similar restrictions in recent years, but the measures were vetoed by then-Gov. Janet Napolitano (D). Current Gov. Jan Brewer (R) has said she supports mandatory disclosures and a 24-hour waiting period (Billeaud, AP/Arizona Daily Star, 6/10).~ North Carolina: The North Carolina Senate Mental Health and Youth Services Committee this week approved a bill (S. 221) that would require all public school systems to offer information on the use of contraceptives to students in grades seven through nine, the AP/Raleigh News & Observer reports. The information would be presented as part of a larger reproductive health education program that would maintain the abstinence-only education curricula currently taught at nearly all of the state"s 115 school districts. Parents would be permitted to prevent children from participating in the classes with contraceptive information. The measure is a revised version of state House-approved legislation (H.B. 88) that would have required schools to teach two separate abstinence-only and comprehensive sex education tracks. If the full state Senate passes the new bill, the two chambers will meet to negotiate a compromise (Robertson, AP/Raleigh News & Observer, 6/11).
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MDRNA, Inc. Receives Full FDA Approval Of Generic Calcitonin-Salmon Nasal Spray For Osteoporosis
MDRNA, Inc. (NASDAQ: MRNA) announced that it has obtained full U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis and that Par Pharmaceutical Companies, Inc. (NYSE: PAR) has launched the product.
Oncology

ASH And EHA Jointly Announce Translational Research Training In Hematology Program

In an effort to foster global biomedical research that will ultimately lead to new and improved treatments for patients with blood diseases, the American Society of Hematology (ASH) and the European Hematology Association (EHA) have collaborated to create the Translational Research Training in Hematology (TRTH) program. This program will provide promising translational investigators an opportunity to undertake intensive training in the causes, diagnosis, and experimental treatment of hematologic disorders from some of the most recognized names in the field. "The next generation of translational researchers will need to understand how to direct research in both the European and U.S. systems," said TRTH co-director and past ASH president Kenneth Kaushansky, MD. "This unique cross-cultural program provides participants with ongoing mentoring, a supportive peer network, and a depth of knowledge and experience that will help position them as global leaders in the field of translational research." The inaugural TRTH will bring 20 early-career scientists to Marbella, Spain, during the week of March 20-26, 2010. Practical sessions will focus on career development, featuring career retrospectives from leaders in the field of hematology and panel discussions on grant preparation and funding s; while instructional sessions will prepare participants to conduct hypothesis-driven research, design phase I and II clinical trials, and utilize animal models, diagnostics, and biomarkers in translational research. "This rigorous one-week training course will allow participants to work with faculty in small groups to review and refine their individual research proposals," said program co-director and EHA president Willem Fibbe, MD. "The goal is for each of them to leave here with a competitive proposal so that they are ready to take the next step in applying for funding. We look forward to hearing about their progress when the group reconvenes at the ASH and EHA annual meetings." Medical trainees, biomedical trainees, and pharmaceutical doctorate trainees generally within 12 years of MD graduation or with less than eight years of post-doctoral experience are encouraged to apply; trainees must be an EHA or ASH member. Applications will be available on the ASH and EHA Web sites starting June 15, 2009. The American Society of Hematology is the world"s largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. In September, ASH launched Blood: The Vital Connection , a credible online re addressing bleeding and clotting disorders, anemia, and cancer. It provides hematologist-approved information about these common blood conditions including risk factors, preventive measures, and treatment options. The European Hematology Association aims to promote excellence in clinical practice, research, and education in European hematology. Today, EHA - with over 3,000 active members from 95 countries - is a consolidated organization that pursues a large and growing number of projects and programs. European Hematology Association


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