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FDA Accepts SNDA For Alternative Dosing Regimen For Dacogen(R) (decitabine For Injection) To Treat Patients With Myelodysplastic Syndromes (MDS)
Eisai Corporation of North America announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company"s supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen(R) (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells.
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New Ovarian Transplant Technique Could Expand Use Of Procedure To Preserve Fertility
Two recent advancements in ovarian transplant techniques could potentially expand the availability of the procedure for women seeking to avoid fertility problems as they age, researchers reported Monday at a meeting of the European Society of Human Reproduction and Embryology, the AP/Yahoo! News reports. According to the AP/Yahoo! News, ovary transplants traditionally have been performed on women with cancer as a method of preserving fertility after chemotherapy or other treatments that can affect the reproductive system. The procedure involves removing the ovaries before treatment and re-implanting them after treatment is complete. Because only a handful of these procedures have been successful, ovarian transplants have been an option only for women with serious diseases. However, as more women delay having children until their 30s or 40s, researchers say the new techniques, in theory, could make it simpler for healthy younger women to have an ovary removed, frozen and then re-implanted later in life when they are ready to have children.The first study examined how many eggs were lost or preserved in fresh and frozen ovarian tissue of 15 young women prior to the start of cancer treatment. According to the study, there was no difference in the quantity of eggs in the fresh tissue and in the ovaries frozen using a new ultra-fast technique. The study found that about 50% of a woman"s eggs were lost using the traditional, slow-freezing methods of preserving the ovaries.The second study reported on a new surgical technique to restore an ovary"s function after transplantation. For the study, Pascal Piver of Limoges University Hospital and colleagues divided the transplant process into two separate procedures in an attempt to more quickly re-establish blood and hormone supplies to the ovary. In the first procedure, the researchers performed a graft of small pieces of ovarian tissue to prompt blood vessels to grow. They performed the ovary transplant three days later. The technique was successful in a woman who lost fertility because of treatment for sickle cell anemia.Sherman Silber, director of the St. Louis Infertility Center in Missouri and a researcher for the first study, said the new techniques "could dramatically expand our reproductive life span." He added, "This is not an experimental procedure for cancer patients anymore. The question is whether more women should be able to have this option" (Cheng, AP/Yahoo! News, 6/29).
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Micrus Endovascular Announces Positive DeltaPaq Microcoil Study Results
Micrus Endovascular Corporation (NASDAQ:MEND) announced that study results presented recently at the 10th Congress of the World Federation of Interventional and Therapeutic Neuroradiology (WFITN) demonstrated that the DeltaPaq™ microcoil"s proprietary design appears to improve the uniformity of coil distribution within a cerebral aneurysm and the degree of microcoil packing in the aneurysm dome and neck, which may reduce the risk of aneurysm recurrence. Bernard R. Bendok, M.D., Assistant Professor of Neurological Surgery and Radiology, Department of Neurological Surgery of Northwestern University Feinberg School of Medicine, and Matthew Gounis, Ph.D., Director of the New England Center for Stroke Research at the University of Massachusetts, served as principal investigators for the Micrus-sponsored in vitro study.
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Mayo Clinic Proceedings: A Comprehensive Review Of Addiction To Prescription Painkillers Among Patients And Physicians

Chemical dependency and recovery in patients and physicians are closely examined in a series of articles and editorials in the July 2009 issue of Mayo Clinic Proceedings. The subject is especially timely. As the immense challenges, including potential tragedies, of prescription chemical addiction and abuse are being discussed, these articles offer crucial overview, direction and optimism. Addiction to and abuse of prescription opioid drugs are prevalent, and they exact an immense toll on patients, physicians and society, according to Steven Passik, Ph.D., Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, in "Issues in Long-Term Opioid Therapy: Unmet Needs, Risks, and Solutions." Opioid drugs have been used by humans for thousands of years and are the longest continuously used class of medications, explains William Lanier, M.D., editor-in-chief of Mayo Clinic Proceedings. Dr. Lanier and Evan Kharasch, M.D., Ph.D., Department of Anesthesiology, Washington University in St. Louis, authored the editorial "Contemporary Clinical Opioid Use: Opportunities and Challenges." It summarizes the recent increased interest in this drug category. Opioid medications are chemicals that work by binding to specific receptors, particularly in the nervous system and gastrointestinal tract; decrease perception of pain and reaction to pain; and increase pain tolerance. Side effects include sedation, respiratory depression and constipation. When opioid consumption is ongoing, physical dependence can and will develop. This, in turn, can lead to problematic withdrawal upon abrupt discontinuation of medication. Dependence, coupled with the feeling of euphoria these drugs can produce, leads to abuse. According to Dr. Lanier, the recent growing interest in opioids stems from five s: advances in the design of these drugs; expansion and innovation in methods of drug delivery; increased public awareness of pain management options and the appropriateness of aggressively treating pain as the "fifth vital sign" and pain relief as a fundamental human right; growing recognition of the serious consequences of opioid misuse, misadventure and addiction; and medicolegal aspects of practitioners" prescribing practices and legal consequences for under- or overprescribing. In addition to individuals who have chronic pain, both cancer and non-cancer related, anesthesiologists have the greatest risk of opioid dependence and abuse among health care providers. Also in the high-risk group for health care providers are nurse anesthetists and sedation nurses. Challenges specific to these groups are discussed by Michael Oreskovich, M.D., Washington Physicians Health Program in Seattle, and Ryan Caldeiro, M.D., Department of Psychiatry and Behavioral Sciences at the University of Washington, Seattle, in "Anesthesiologists Recovering From Chemical Dependency: Can They Safely Return to the Operating Room?" Severe chronic pain includes that produced by cancer and such non-cancer conditions as back injury and surgery. Opioids are a cornerstone of pain management for individuals in these categories, according to Howard Smith, M.D., Department of Anesthesiology, Albany Medical College, N.Y. In "Opioid Metabolism," he writes that approximately 10 percent to 20 percent of physicians will develop a substance abuse problem during their career, a rate similar to or exceeding the general population. For anesthesiologists, according to Drs. Oreskovich and Caldeiro, the increased risk is cited as an occupational hazard because of the highly addictive medications they administer to patients daily. Health care professionals helping patients with chronic pain must balance aggressive treatment with the need to minimize the risks of misuse and abuse, according to Dr. Passik. In "A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain," Charles Argoff, M.D., and Daniel Silvershein, M.D., both from the Department of Neurology, Albany Medical College, N.Y., write that management of chronic non-cancer pain, for example, requires comprehensive assessment of each patient; the establishment of a structured treatment regimen or program; ongoing reassessment of the pain condition and the response to therapy; and a continual appraisal of the patient"s adherence to the treatment. Their colleague, Dr. Smith, stresses the importance of understanding the metabolism of opioids in individual patients. Keen awareness by family and friends of potential addiction is crucial for physicians and other health care providers, not to mention the general public, who might be at risk, according to "Chemical Dependency and the Physician" by Keith Berge, M.D., Department of Anesthesiology, Mayo Clinic; Marvin Seppala, M.D., Hazelden Foundation, Center City, Minn.; and Agnes Schipper, J.D., Mayo Clinic Legal Department. Especially important is that family, friends and co-workers of health care providers confront any suspected addiction and abuse because of the potential harm that might befall the individual and his or her patients. Health care facilities should have written policies and procedures in place to assist when these highly emotionally charged situations involving health care providers occur, Dr. Berge and his colleagues write. Long-term recovery and sobriety can be achieved with appropriate treatment, aftercare and monitoring, they add. New opioid formulas designed to minimize abuse are now in late-stage development and could help, Dr. Passik says. These drugs are chemically designed to diminish euphoric effects, thus possibly reducing problematic use. For now, responsibility coupled with expertise, insight, diligence and compassion are among the components that can meet the challenges of opioid use in pain management, the authors agree. A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. About Mayo Clinic Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy that "the needs of the patient come first." More than 3,300 physicians, scientists and researchers and 46,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Collectively, the three locations treat more than half a million people each year. Mayo Clinic


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