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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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Consumer Alert: Minimally Invasive Cosmetic Procedures Should Not Be Taken Lightly
Today, there are more ways than ever before to "get a little work done." From skin fillers to fat-reduction procedures, the options are endless for those looking to improve their appearance and boost their self-esteem. But with so many physicians and options from which to choose, consumers can be confused about where to start and who to trust to perform a cosmetic procedure.
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Kaiser Daily Health Policy Report Feature Highlights Recent Blog Entries
"Blog Watch" offers readers a roundup of health policy-related blog posts.Bloggers are tentatively reacting to a report and blog post released by the Congressional Budget Office that summarizes the agency"s approach to estimating the cost of any health overhaul bills. At issue is how CBO will count different stipulations of legislation -- like an individual mandate or a public plan -- and whether their conclusions will result in a heftier price tag. Douglas Elmendorf explained on the Director"s Blog: "In CBO"s view, the key consideration is whether a proposal would be making health insurance an essentially governmental program, tightly controlled by the federal government with little choice available to those who offer and buy health insurance -- or whether the system would provide significant flexibility in terms of the types, prices, and number of private-sector sellers of insurance available to people. The former -- a governmental program -- belongs in the federal budget (including all premiums paid by individuals and firms to private insurers), but the latter -- a largely private-sector system -- does not." Janet Adamy of the Wall Street Journal"s Washington Wire notes that the report doesn"t address the cost estimates of the scenarios. Alan Katz on his Health Care Reform Blog concludes, "the message is clear: the looser government"s hand grips the new health care system the smaller its budgetary impact." Liberal bloggers had a variety of reactions -- some found the report too vague, while others saw it as good news. The New Republic"s Jonathan Cohn says, "you may need a Talmudic scholar to figure out what those implications are." Cohn continues, "Other passages in the briefing are [similarly] vexing and, for what it"s worth, the reactions I"ve gotten from insiders familiar with the report have ranged from sighs of relief to statements not suitable for a family blog." Ezra Klein agrees the report lacks specificity, but says, "Even so, I"m cheered by the simple existence of this ruling. The fact that CBO is explaining its thinking before legislation arrives [is] yet more evidence that CBO appears, insofar as it can, to be trying to help out on health reform. ... That"s an important change from past years." Interesting Elsewhere:
Oncology

International Stem Cell Collaboration Results In Discovery Of Promising New Stem Cell Type

DaVinci Biosciences LLC in collaboration with University of Utah, Southern California Center for Regenerative Medicine and Omni Hospital in Ecuador, announce the discovery of a previously unidentified stem cell population from adult human testis in Biochemical and Biophysical Research Communications (BBRC), an international peer-reviewed journal focused on the rapid dissemination of timely and significant experimental results in diverse fields of biological research. Termed gonadal stem cells (GSCs) these adult derived stem cells, unlike previous reported population of stem cells found within the testis, have been found to demonstrate adult stem cell properties. Published in the current journal of Biochemical and Biophysical Research Communications, the data from this collaborative study describes a multipotent adult stem cell population that has the capacity to readily differentiate into multiple cell types. The study evolved from an international collaboration aimed at identifying novel cell populations at different geographical laboratory locations and for different HLA types. "We began this study purely as an approach to study and identify novel cell types and mechanisms regulating the role of infertility," said Francisco Silva, President of DaVinci Biosciences. "We were surprised and delighted to find a cell population that demonstrated these stem cell properties." Dr. Amit Patel, Director of Cardiovascular and Regenerative Medicine for the University of Utah School of Medicine and senior author of the study is currently collaborating with DaVinci Biosciences to study the genetic diversity of different cell populations and their role in personalized medicine. "We are establishing a database of genomic and cell characteristics that can eventually be correlated and placed into clinically translational therapeutic models that would ultimately help patients seeking to be treated with new pharmaceutical and cell-based therapies," said Dr. Patel. "In our attempt to expand cells from this tissue and study the genetics of the cell we found a population of cells that behaved like stem cells which could have therapeutic significance." The BBRC publication describes the cell population as having a high propensity to differentiate into chondrogenic and osteogenic cell types or cartilage and bone like cells, potentially leading to their use for orthopedic indications. Adult stem cells have been identified and described in various adult tissues to date and this published report is the first to identify an adult stem cell population from human testis with significant promise for new clinical applications. About DaVinci Biosciences DaVinci Biosciences LLC is a privately held company dedicated to advancing therapies that improve the quality of life for individuals suffering from trauma, disease and degenerative disorders. Through independent research and partnerships with universities, medical research institutions, and hospitals, DaVinci Biosciences continues to discover biological breakthroughs relating to and further improving the treatment of degenerative disorders and injury. DaVinci Biosciences is headquartered in Costa Mesa, California. For more information please visit www.dvbiosciences.com. About BBRC Biochemical and Biophysical Research Communications is the premier international journal devoted to the very rapid dissemination of timely and significant experimental results in diverse fields of biological research. The development of the "Breakthroughs and Views" section brings the minireview format to the journal, and issues often contain collections of special interest manuscripts. BBRC is published weekly (52 issues/year). Biochemical and Biophysical Research Communications


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