The Mount Sinai journal of medicine, New York
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New-drug approvals have remained roughly constant since 1950, while the cost of drug development has soared. It seems likely that a more modular approach to drug discovery and development will evolve, deriving some features from the not-for-profit sector. ⋯ These developments, likely prompted by the perception of crisis rather than opportunity, will require linked initiatives among academia, the pharmaceutical industry, the US National Institutes of Health, and the US Food and Drug Administration, along with a more adventurous role for venture capital. A failure to respond threatens the United States' lead in biomedical science and in the development and regulation of novel therapeutics.
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The drug discovery and development enterprise, traditionally an industrial juggernaut, has spanned into the academic arena that is partially motivated by the National Institutes of Health Roadmap highlighting translational science and medicine. Because drug discovery and development represents a pipeline of basic to clinical investigations, it meshes well with the "bench to the bedside" prime directive of translational medicine. ⋯ One area that has received limited attention concerns the use of pharmacokinetic and pharmacodynamic studies in the drug-development process. Using anticancer drug development as a focus, this review will address past and current deficencies in how pharmacokinetic/pharmacodynamic studies are conducted and offer new strategies that might bridge the gap between preclinical and clinical trials.
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Family members used as patients' interpreters are a common occurrence in the medical environments of multicultural societies. It is recognized that the use of the family-member interpreter may have some benefits. ⋯ While numerous studies have been done on the challenges in the doctor-interpreter-patient medical encounter, these studies tend to focus on the experiences of the physicians or the patients, and the perspective of the interpreter is often sidelined. After discussing the various interpreting options, we suggest that the perspective of the family-member interpreter strengthens assertions that professional interpretation is the best option for multilingual medical environments.
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The treatment of thoracic aortic disease has changed radically with the advances made in endovascular therapy since the concept of thoracic endovascular aortic repair was first described 15 years ago. Currently, there is a diverse array of endografts that are commercially available to treat the thoracic aorta. Multiple studies, including industry-sponsored and single-institution reports, have demonstrated excellent outcomes of thoracic endovascular aortic repair for the treatment of thoracic aortic aneurysms, with less reported perioperative morbidity and mortality in comparison with conventional open repair. ⋯ However, the technology remains relatively novel, and larger studies with longer term outcomes are necessary to more fully evaluate the role of endovascular therapy for the treatment of thoracic aortic disease. This review examines the currently available thoracic endografts, preoperative planning for thoracic endovascular aortic repair, and outcomes of thoracic endovascular aortic repair for the treatment of both thoracic aortic aneurysms and type B aortic dissections. Mt Sinai J Med 77:256-269, 2010. (c) 2010 Mount Sinai School of Medicine.
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The incidence of subarachnoid hemorrhage is estimated at 5 to 10 per 100,000 per year. In patients who survive the initial hemorrhage, the repeat hemorrhage rate is 15% to 20% in the first 2 weeks after presentation and is associated with devastating clinical outcomes even graver than the initial rupture. The current options for aneurysm treatment are surgical clipping and, since the mid-1990s, neuroendovascular coil embolization. ⋯ Although there is still controversy as to its long-term durability and safety, it is now the preferred procedure. This article describes the procedure's antecedents, rationale, and essential components. Mt Sinai J Med 77:279-285, 2010. (c) 2010 Mount Sinai School of Medicine.