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The European Experience: The Pluses And Minuses Of Government-Run Health Care
As President Barack Obama pushes to overhaul health care, many look to Europe for examples of government-run health care.
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Hyperion Therapeutics Receives Special Protocol Assessment Approval From FDA For Pivotal Phase III Trial In Urea Cycle Disorders
Hyperion Therapeutics announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the pivotal Phase III trial of investigational product HPN-100 (glycerol phenylbutyrate) in adults with urea cycle disorders (UCD). The SPA is a written agreement between the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase III trial to be used in support of a New Drug Application (NDA).
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Advocates Eager To Learn More About Supreme Court Nominee Sotomayor's Abortion-Rights Views
Abortion-rights groups on Wednesday offered their support for Supreme Court nominee Judge Sonia Sotomayor but said that they were eager to learn more about her views on abortion rights, an issue on which she has made few major rulings in her time as a judge, the New York Times reports. According to the Times, groups on both sides of the abortion-rights debate tend to believe that Sotomayor would uphold Roe v. Wade because she was nominated by President Obama, who supports abortion rights. However, when asked on Tuesday if Obama questioned Sotomayor about her views on abortion rights before the nomination, White House spokesperson Robert Gibbs said that the president "did not ask that specifically." In addition, none of her rulings has directly dealt with the underlying issues of constitutional privacy that are the foundation for the Roe decision, according to the Times. The abortion-related cases Sotomayor has handled in the past have "turned on other legal issues," rather than privacy, and they have resulted in rulings in favor of abortion-right opponents, the Times reports. For example, in 2002, she wrote an opinion upholding the Bush administration"s "global gag rule" policy banning federal funding of international groups that offer abortion information or services. "The Supreme Court has made clear that the government is free to favor the antiabortion position over the pro-choice position and can do so with public funds," Sotomayor wrote in the opinion. In 2004, she said that antiabortion-rights protesters were permitted to sue police who they claimed used excessive force in stopping a demonstration at a clinic. Sotomayor also has ruled on several immigration cases related to people fighting deportation orders to China over its family planning policies, the Times reports. Because of the limited information on Sotomayor"s abortion-rights views, advocates have stressed that senators ask questions about her views during her confirmation hearing. NARAL Pro-Choice America President Nancy Keenan in a letter to supporters urged them to press senators to ask Sotomayor about privacy rights. Keenan wrote, "Discussion about [Roe] will -- and must -- be part of this nomination process. As you know, choice hangs in the balance on the Supreme Court as the last two major choice-related cases were decided by a 5-to-4 margin" (Savage, New York Times, 5/28). Nancy Northup, president of the Center for Reproductive Rights, said that she would be surprised if an Obama nominee did not support abortion rights but added that "other presidents have been surprised before" when their nominees" views did not align with their assumptions. Northup said that "no one has been able to give us an assurance" of Sotomayor"s views on abortion rights, adding that she would be "very concerned if the question is not asked and answered during the Senate hearings." Feminist Majority Foundation President Eleanor Smeal said, "What we know about [Sotomayor] we like, but I don"t know that answer on abortion rights" (Savage/Nicholas, Los Angeles Times, 5/28). The New York Times reports that more about Sotomayor"s views on abortion rights could come to light if a past writing on the subject surfaces, as was the case during Justice Samuel Alito"s confirmation process. Steven Waldman, editor in chief of beliefnet.com, said, "Everyone is just assuming that because Obama appointed her, she must be a die-hard pro-choice activist, but it"s really quite amazing how little we know about her views on abortion" (Savage, New York Times, 5/28). Thomas Goldstein, a leading appellate attorney and founder of scotusblog.com, said that the "fact that she hasn"t gone off on these sorts of questions" on contentious topics like abortion rights and gay marriage, "I think shows that honestly she"s not a dyed in the wool liberal." He added that there are issues on which Sotomayor could prove to be more conservative than retiring Justice David Souter (Lerer, Politico, 5/27).According to the Washington Post, many antiabortion-rights supporters are critic
Cardiovascular

From Molecular Physiology To Therapeutic Applications Of Stem Cells

Stem cell research promises remedies to many devastating diseases that are currently incurable, ranging from diabetes and Parkinson"s disease to paralysis. Totipotent embryonic stem cells have great potential for generating a wide range of different human cells that can be used to restore malfunctioning or damaged cells and tissues in patients. Recent studies have shown that pluripotent stem cells derived from adult bone marrow, the umbilical cord and the placenta could also be induced to differentiate into a variety of different tissues. In this issue, we have invited several scientists in China to summarize their pioneering works in the stem cell research field. Since 2001, Dr. Alex Yu Zhang has been a professor at Capital Medical University in Beijing and is Director of Cell Therapy Center at Xuanwu Hospital. His current research interest focuses on the understanding of basic biological properties of stem cells and developing nonhuman primate models for stem cell-based therapy of degenerative diseases. He has developed a stem cell mediated expression system for treating Parkinson"s disease and his research using pancreatic progenitor cells for treating diabetes has demonstrated efficacy in monkey models. Professor Zhang has written an overview of cell replacement therapy of Parkinson"s disease, which has been studied in both animal models and human patients for more than 20 years. Recent progress in stem cell biology has indicated that it is possible to avoid immunorejection of either nuclear transfer embryonic stem cells or induced pluripotent stem cells. On the other hand, recent post mortem analysis of patients who received fetal brain cell transplantation revealed that implanted cells are prone to degeneration just like endogenous neurons. Thus it appears that future cell replacement studies will have to focus on ameliorating disease symptoms as well as on slowing the progression of the disease[1]. Professor Robert Chunhua Zhao from the Chinese Academy of Medical Sciences is Executive Director of the National Center for Stem Cell Research. His group has taken stem cell therapy into phase II clinical trials in China, and is the leading runner in stem cell therapeutics. They have identified a mesenchymal stem cell (MSC) population from human fetal bone marrow and found that these cells could differentiate not only into osteogenic, adipogenic and endothelial lineages, but also hepatocyte-like cells, and neural and erythroid cells. They remained in some tissues and organs during gestation and could give rise to different kinds of pluripotent stem cells and thus could potentially contribute to self-repair and self-renewal of tissues and organs. They generated cells not only for the damaged tissues in which they reside, but also for damaged tissues at other locations in the body via migration triggered by proinflammatory cytokines and growth factors. The potential use of MSCs in tissue regeneration has been shown in several models, including skin, muscle, lung, heart and the small intestine. MSCs have emerged as a promising therapeutic modality for tissue regeneration and autoimmune disease, although the mechanisms underlying the immune-modulatory effects of MSCs have not yet been clearly defined. In this review, Professor Robert Zhao summarizes the current literature on the complex mechanism of MSCs" immune modulation and clinical studies, and discusses future directions for utilizing MSCs for clinical treatments[2]. Professor Hongkui Deng from Peking University is working on the differentiation of human embryonic stem cells into pancreatic beta cells to treat diabetes. He is one of the two winners in China of the Bill and Melinda Gates Foundation"s "Grand Challenges in Global Health". He obtained $1.9 million for his proposal to use stem cells to create mouse models for testing HIV and hepatitis C vaccines. Professor Deng has written a summary of recent progress in human embryonic and inducible pluripotent stem cell differentiation into functional pancreatic islet cells and discusses the challenges for future work[3]. Professor Qi Zhou is assistant Director of the Institute of Zoology at the Chinese Academy of Sciences. He has been studying the mechanism of differentiation and de-differentiation, cellular plasticity and totipotency of pluripotent cells, as well as that of somatic cells. He intends to build various cellular and animal models for human diseases, to uncover mechanisms underlying these different cellular processes and to discover new ways to improve cloning efficiency, which will provide a powerful tool for the study of mammalian reprogramming and ultimately offer important opportunities for regenerative medicine. Professor Zhou has helped to build the National Stem Cell Bank in Beijing, where clinical grade stem cell lines and patient specific cell lines have been created for future drug target candidate screening and therapeutic applications. Professor Qi Zhou has written a summary on human parthenogenetic embryonic stem cells as one potential re for stem cell therapy[4]. Professor Lin Liu from Nankai University has been working on creating versatile patient-specific pluripotent stem cell lines that can be reliably used to fulfill the promise of stem cell therapy in regenerative medicine. Dr. Lin Liu"s group found that pES cells generated from immature oocytes in mice exhibit pluripotency resembling fES cells, as evidenced by similarly high chimera production and germline transmission. Thus, immature eggs may provide an efficient of autologous stem cells for regenerative medicine. This group also tested whether pESCs can be generated from older females. Drs. Lingyi Chen works on mechanisms of early embryonic differentiation. In their review of current special topics on stem cells, Drs. Lingyi Chen and Lin Liu analyze the current state of iPS research, particularly on limitations and advancements in this field, and propose possible future directions to meet the challenges of iPS cells for clinical applications[5]. Stem cell research has made significant progress in the past decade. Some therapeutic applications are coming closer to being on the market, but it is still hard to predict if and when stem cell therapy will replace largely traditional therapeutics. Given the early indications for success, we hope to see promising remedies for the many current uncurable diseases being made available in the clinic over the coming years. Notes: * Ren Z, Zhang Y. Cell therapy for Parkinson"s disease - So close and so far away. Sci China C-Life Sci, 2009, 52: 610-614 * Wang L, Zhao R C. Mesenchymal stem cells targeting the GVHD. Sci China C-Life Sci, 2009, 52: 603-609 * Zhang D, Jiang W, Shi Y, et al. Generation of Pancreatic islet cell from human embryonic stem cell. Sci China C-Life Sci, 2009, 52: 615-621 * Hao J, Zhu W, Sheng C, et al. Human parthenogenetic embryonic stem cells: One potential re for cell therapy. Sci China C-Life Sci, 2009, 52: 622-636 * Chen L, Liu L. Current progress and prospect of induced pluripotent stem cell. Sci China C-Life Sci, 2009, 52: 622-636 Li Jiyuan Science in China Press


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