International journal of technology assessment in health care
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Int J Technol Assess Health Care · Jan 1992
ReviewProblems in assessing the technology of critical care medicine.
Technology assessment is becoming increasingly important in the area of critical care due both to the explosion of technology associated with this discipline and to the realization that future demand for these health care resources will undoubtedly exceed the ability to pay. Technology assessment remains both confusing and controversial to many physicians. ⋯ From there, problems and prospects for the evaluation of critical care as a program are presented, followed by the assessment of components within the area of critical care. Finally, recommendations are made on how technology assessment could proceed in the future to best achieve the efficient provision of this service.
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The 1983 Orphan Drug Act was designed in response to market and regulatory disincentives that limited industrial interest in developing drugs needed by people in the United States with rare diseases and conditions. These disincentives evolved from changes in the pharmaceutical industry and in regulatory testing requirements. In the eight years since the Act and subsequent amendments have been in effect, the law has been associated with the new development and approval of 40 marketed drugs and 12 biologicals to treat rare (orphan) diseases. ⋯ Finally, the law has mandated exploration of whether the incentives of the Act are necessary and appropriate for stimulating industrial development of orphan medical drugs and devices. Despite this progress, controversies have arisen over three profitable orphan products that have benefited from the law's provisions. This has created the need for continued assessment of the Act's benefits and costs.
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It is difficult to study the epidemiology of ICUs, as they lack a uniform nomenclature and/or classification. The organization and distribution of intensive care medicine depend on the size and function of the hospital. The patients in ICUs are predominantly men, with a high proportion of elderly patients (greater than or equal to 70 years) constituting 25-30% of the total. ⋯ Most survivors of intensive care seem to return to normal or near normal functional level within one year. Compared to Western Europe, the United States has more ICU beds and a nearly ten times higher admission rate to intensive care. These variations can be seen as a result of a fundamental difference in the attitudes toward withdrawing or withholding life support.
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Int J Technol Assess Health Care · Jan 1992
Evaluation of orphan products by the U.S. Food and Drug Administration.
Orphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. ⋯ Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U. S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.