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Moreover, because of pleiotropy, a genetic variation associated with drug response may be found also to be associated with an increased disease risk. The NAT2 enzyme, involved in detoxification of many carcinogens and the metabolism of many common drugs, is an example. Genetic variation in NAT2 may predict toxic effects of drugs and "may contribute to racial and ethnic variation in the incidence of environmentally induced cancers." E. G. Burchard, E. Ziv, N. Coyle, and S. L. Gomez, "The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice,"New England Journal of Medicine
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Moreover, because of pleiotropy, a genetic variation associated with drug response may be found also to be associated with an increased disease risk. The NAT2 enzyme, involved in detoxification of many carcinogens and the metabolism of many common drugs, is an example. Genetic variation in NAT2 may predict toxic effects of drugs and "may contribute to racial and ethnic variation in the incidence of environmentally induced cancers." E. G. Burchard, E. Ziv, N. Coyle, and S. L. Gomez, "The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice,"New England Journal of Medicine 348, no. 12 (2003): 1170-1175
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An additional burden for the elder African-American population is the fact that depression is associated with these conditions or treatment for them, and African Americans experience these conditions at disproportionate rates. Establishing the efficacy of antidepressants in African Americans, especially those middle-aged and older, is thus a necessary feature of adequately addressing multiple health problems facing an aging African-American population and providing them nondisparate care.
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An additional burden for the elder African-American population is the fact that depression is associated with these conditions or treatment for them, and African Americans experience these conditions at disproportionate rates. Establishing the efficacy of antidepressants in African Americans, especially those middle-aged and older, is thus a necessary feature of adequately addressing multiple health problems facing an aging African-American population and providing them nondisparate care.
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This recommendation is made by Brody with regard to other types of research that affect health disparities. L. S. Parker and H. Brody, "Comparative Effectiveness Research and Health Reform: Ethical Issues,"Health Progress 92, no. 5 (2011): 64-71.
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In the 1980s two trials of BiDil (a combination of isosorbide and hydralazine) failed to establish that its effect was comparable or superior to that of an ACE inhibitor, enalapril, for the treatment of heart failure. Most of those enrolled in the 2001 African-American Heart Failure Trial (A-HeFT) were also using ACE inhibitors or betablockers, or both, so that A-HeFT studied and established the effectiveness of BiDil as an addition to standard therapies, which is not the same question the 1980s trials had examined. Whether adding a combination of isosorbide and hydralazine to the current treatment regimens of non-African-American heart failure patients would be beneficial has not been studied in an all-race trial. Evidence that BiDil works well in African-Americans, but not in Whites, is at best ambiguous. G. T. H. Ellison, J. S. Kaufman, R. F. Head, P. A. Martin, and J. D. Kahn, "Flaws in the U.S. Food and Drug Administration's Rationale for Supporting the Development and Approval of BiDil as a Treatment for Heart Failure Only in Black Patients,"Journal of Law, Medicine & Ethics 36, no. 3 (2008): 449-457.
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Such sentiments were expressed, for example, at the April 7, 2006 conference, Race, Pharmaceuticals, and Medical Technology, sponsored by the Center for the Study of Diversity in Science, Technology, and Medicine of the Massachusetts Institute of Technology, as reported by University of California Hastings College of Law professor, Osagie K. Obasogie, available
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Such sentiments were expressed, for example, at the April 7, 2006 conference, Race, Pharmaceuticals, and Medical Technology, sponsored by the Center for the Study of Diversity in Science, Technology, and Medicine of the Massachusetts Institute of Technology, as reported by University of California Hastings College of Law professor, Osagie K. Obasogie, availablehttp://www.biopoliticaltimes.org/article.php?id=20182012
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There are apparent incentives not to conduct such a study: BiDil is currently approved for marketing to African-American patients, and other patients may be prescribed BiDil on an off-label basis, thereby expanding its market. The generation of evidence that the combination is beneficial in other populations would actually undermine the rationale for FDA approval of BiDil, its patented status, and its marketing strategy. Ironically, showing that BiDil is suitable for the majority of genotypes - or that genotype is largely irrelevant to its effectiveness - would reduce its profitability.
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There are apparent incentives not to conduct such a study: BiDil is currently approved for marketing to African-American patients, and other patients may be prescribed BiDil on an off-label basis, thereby expanding its market. The generation of evidence that the combination is beneficial in other populations would actually undermine the rationale for FDA approval of BiDil, its patented status, and its marketing strategy. Ironically, showing that BiDil is suitable for the majority of genotypes - or that genotype is largely irrelevant to its effectiveness - would reduce its profitability.
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U.S. Department of Health and Human Services, Pharmacogenomics Knowledge Base, PharmGKB, available at last visited March 9, 2012); also quoted, for example, in C. C. Khoon, Genomics and Population Health: A Social Epidemiology Approach, in Genomics and Bioethics: An Interdisciplinary Perspectives, Technologies, and Advancements, ed. Soraj Hongladarom (Hershey, PA: Medical Information Science Reference, .)
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U.S. Department of Health and Human Services, Pharmacogenomics Knowledge Base, PharmGKB, available at last visited March 9, 2012); also quoted, for example, in C. C. Khoon, Genomics and Population Health: A Social Epidemiology Approach, in Genomics and Bioethics: An Interdisciplinary Perspectives, Technologies, and Advancements, ed. Soraj Hongladarom (Hershey, PA: Medical Information Science Reference, .)http://www.pharmgkb.org/resources/forGeneralUsers/pharmacogenetics_pharmacogenomics_anpersonalized_medicine.jsp2011
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