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Ethical Dimensions of Disparities in Depression Research and Treatment in the Pharmacogenomic Era

Published online by Cambridge University Press:  01 January 2021

Extract

Personalized medicine with its promise of developing interventions tailored to an individual's health need and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. In addition, understanding depression not merely in biochemical terms but also in genetic terms might seem to counter cultural beliefs and stigma that attach to depression when conceived as a mood or behavioral problem under an individual's control. After all, if there is one thing for which a person is not responsible and cannot be blamed, it is her genes. Nevertheless, for multiple reasons, a personalized medical approach to depression treatment, and its attendant conceptualization of depression and treatment response as genetically influenced, present the risk of exacerbating well-documented disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults.

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Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

Dobransky-Fasiska, D. Brown, C., and Pincus, H. A. et al., “Developing Community-Academic Partnership to Improve Recognition and Treatment of Depression in Underserved African American and White Elders,” American Journal of Geriatric Psychiatry 17, no. 11 (2008): 953964; Simpson, S. M. Krishnan, L. L. Kunik, M. E., and Ruiz, P., “Racial Disparities in Diagnosis and Treatment of Depression: A Literature Review,” Psychiatric Quarterly 78, no. 11 (2007): 3–14.Google Scholar
Jones, C. P., “Levels of Racism: A Theoretic Framework and a Gardener's Tale,” American Journal of Public Health 90, no. 8 (2000): 12121215.Google Scholar
Riolo, S. A. Nguyen, T. A. Greden, J. F., and King, C. A., “Prevalence of Depression by Race/Ethnicity: Findings from the National Health and Nutrition Examination Survey III,” American Journal of Public Health 95, no. 6 (2005): 9981000; Williams, D. R. Gonzalez, H. M., and Heighbors, H. et al., “Prevalence and Distribution of Major Depressive Disorder in African Americans, Caribbean Blacks, and Non-Hispanic Whites,” Archives of General Psychiatry 64, no. 3 (2007): 305–315.CrossRefGoogle Scholar
In the balance of this paper, we shall adopt the convention of referring to “African Americans” in discussing these disparities and will use the term to refer to the diverse group of “Black” populations in the U.S. We will specify when data or claims refer to specific populations (e.g., Caribbean Blacks) or to older African Americans. Miranda, J. and Cooper, L. A., “Disparities in Care for Depression Among Primary Care Patients,” Journal of General Internal Medicine 19, no. 2 (2004): 120126; see Simpson, et al., supra note 1; Williams, et al., supra note 3.CrossRefGoogle Scholar
See Dobransky-Fasiska, et al., supra note 1; Das, A. K. Olfson, M. McCurtis, H. L., and Weissman, M. M., “Depression in African Americans: Breaking Barriers to Detection and Treatment: Community-Based Studies Tend to Ignore High-Risk Groups of African Americans,” Journal of Family Practice 55, no. 1 (2006): 3039.Google Scholar
Wittink, M. N. Joo, J. H. Lewis, L. M., and Barg, F. K., “Losing Faith and Using Faith: Older African Americans Discuss Spirituality, Religious Activities, and Depression,” Journal of General Internal Medicine 24, no. 3 (2009): 402407.CrossRefGoogle Scholar
Id.; see Das, et al., supra note 5.Google Scholar
Neighbors, H. W. Caldwell, C., and Williams, D. R. et al., “Race, Ethnicity, and the Use of Services for Mental Disorders,” Archives of General Psychiatry 64, no. 4 (2007): 485494.CrossRefGoogle Scholar
On finding a difference, see Poolsup, N. Li Wan Po, A., and Knight, T. L., “Pharmacogenetics and Psychopharmacotherapy,” Journal of Clinical Pharmacy and Therapeutics 25, no. 3 (2000): 197220; on finding a difference on some measures but not others, see Lesser, I. M. Castro, D. B., and Gaynes, B. N. et al., “Ethnicity/Race and Outcome in the Treatment of Depression: Results from STAR*D,” Medical Care 45, no. 1 (2007): 1043–1051.CrossRefGoogle Scholar
NIH Consensus Development Panel on Depression in Late Life, “Diagnosis and Treatment of Depression in Late Life,” JAMA 268, no. 8 (1992): 10181024.CrossRefGoogle Scholar
Townes, D. L. Chavez-Korell, S., and Cunningham, N. J. et al., “Reexamining the Relationships between Racial Identity, Cultural Mistrust, Help-Seeking Attitudes, and Preference for a Black Counselor,” Journal of Counseling Psychology 56, no. 2 (2009): 330336.CrossRefGoogle Scholar
Miranda, J. McGuire, T. G. Williams, D. R., and Wang, P., “Mental Health in the Context of Health Disparities,” American Journal of Psychiatry 165, no. 9 (2008): 11021108.Google Scholar
Jones, C., “Baring Their Souls: More Middle-Class Blacks Are Turning to Therapists,” Detroit Free Press, September 2, 1997, at Accent Section, available at <http://www.africanamerican-therapists.com/middle-class-blacks/>; Whaley, A. L., “Cultural Mistrust: An Important Psychological Construct for Diagnosis and Treatment of African Americans,” Professional Psychology: Research and Practice 32, no. 6 (2001): 555–562.Google Scholar
Hussain-Gambles, M. Atkin, K., and Leeseet, B., “Why Ethnic Minority Groups Are Under-Represented in Clinical Trials: A Review of the Literature,” Health & Social Care in the Community 12, no. 5 (2004): 382388; Rogers, W. A., “Evidence-Based Medicine and Justice: A Framework for Looking at the Impact of EBM on Vulnerable or Disadvantaged Groups,” Journal of Medical Ethics 20, no. 2 (2004): 141–145; Zulman, D. M. Sussman, J. B., and Chen, X. et al., “Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials,” Journal of General Internal Medicine 26, no. 7 (2011): 783–790.Google Scholar
Alvidrez, J. Arean, P. A., and Stewart, A. L., “Psychoeducation to Increase Psychotherapy Entry for Older African Americans,” American Journal of Geriatric Psychiatry 3, no. 7 (2005): 554561.CrossRefGoogle Scholar
Cooper, L. A. Gonzales, J. J., and Gallo, J. J. et al., “The Acceptability of Treatment for Depression Among African-American, Hispanic, and White Primary Care Patients,” Medical Care 41, no. 4 (2003): 479489; Kanter, J. W. Rusch, L. C., and Brondino, M. J., “Depression Self-Stigma: A New Measure and Preliminary Findings,” Journal of Nervous and Mental Disease 196, no. 9 (2008): 663–670; Rusch, L. C. Kanter, J. W. Manos, R. C., and Weeks, C. E., “Depression Stigma in a Predominantly Low Income African American Sample with Elevated Depressive Symptoms,” Journal of Nervous and Mental Disease 196, no. 12 (2008): 919–922.CrossRefGoogle Scholar
See Cooper, et al., supra note 16; Givens, J. L. Katz, I. R. Bellamy, S., and Holmes, W. C., “Stigma and the Acceptability of Depression Treatments among African Americans and Whites,” Journal of General Internal Medicine 22, no. 9 (2007): 12921297.Google Scholar
Gamble, V. N., “Under the Shadow of Tuskegee: African Americans and Health Care,” American Journal of Public Health 87, no. 11 (1997): 17731778; Boulware, L. E. Cooper, L. A., and Ratner, L. E. et al., “Race and Trust in the Health Care System,” Public Health Report 118, no. 4 (2003): 358–365.CrossRefGoogle Scholar
Roberts, D. E., “Reconstructing the Patient: Starting with Women of Color,” in Wolf, S. M., ed., Feminism and Bioethics: Beyond Reproduction (New York: Oxford University Press, 1996): At 116–143; Gamble (id.).Google Scholar
Brandon, D. T. Isaac, L. A., and LaVeist, T. A., “The Legacy of Tuskegee and Trust in Medical Care: Is Tuskegee Responsible for Race Differences in Mistrust of Medical Care?” Journal of the National Medical Association 97, no. 7 (2005): 951956; Katz, R. V. Kegeles, S. S., and Kressin, N. R. et al., “Awareness of the Tuskegee Syphilis Study and the US Presidential Apology and Their Influence on Minority Participation in Biomedical Research,” American Journal of Public Health 98, no. 6 (2008): 1137–1142.Google Scholar
Sanders, C. J., “Religion and Ethical Decision Making in the African American Community: Bioterrorism and the Black Postal Workers,” in Prograis, L. Jr. and Pellegrino, E. D. eds., African American Bioethics (Washington, D.C.: Georgetown University Press, 2007): At 93–104.Google Scholar
Goldstein, A., “Many Postal Workers Stop Taking Cipro,” Washington Post, December 10, 2001, at B02.Google Scholar
See Sanders, , supra note 21.Google Scholar
See Whaley, , supra note 13.Google Scholar
Id.; In The Protest Psychosis, Jonathan Metzel details how schizophrenia became a different, socially constructed diagnosis for African-American and white patients, and specifically how its diagnosis in African Americans – both in individual doctor-patient interactions and at a cultural level – rEffects racial tensions, the white establishment's anxieties about racial difference, and fear of African-American rage in response to a racist culture. Metzl, J. M., The Protest Psychosis: How Schizophrenia Became a Black Disease (Boston: Beacon Press, 2009).Google Scholar
See Whaley, , supra note 13; Citizens Commission on Human Rights, Creating Racism: Psychiatry's Betrayal (Los Angeles: CCHR International, 2008).Google Scholar
Brunson, C. J., “African Americans and the Mental Health System,” Exodus News, July 27,1999, available at <http://www.exodusnews.com/health/1495-african-americans-and-the-mental-health-system.html> (last visited March 9, 2012).+(last+visited+March+9,+2012).>Google Scholar
Gelenberg, A. J. Freeman, M. P., and Markowitz, J. C. et al., “Practice Guideline for the Treatment of Patients with Major Depressive Disorder Third Edition,” American Journal of Psychiatry 167, no. 10 (2010): 1152.Google Scholar
See Alvidrez, et al., supra note 15.Google Scholar
U.S. Department of Health and Human Services, Mental Health: A Report of the Surgeon General (Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institutes of Health, National Institute of Mental Health, 1999).Google Scholar
See Das, et al., supra note 5.Google Scholar
West, H. C. Sabol, W. J., and Greenman, S. J., “Prisoners in 2009,” Bureau of Justice Statistics Bulletin, December 21, 2010, available at <http://bjs.ojp.usdoj.gov/content/pub/pdf/p09.pdf> (last visited December 5, 2012).+(last+visited+December+5,+2012).>Google Scholar
Indeed, among the arguments made for preservation of the institution of slavery was the need of the American Negro for the protection and structure afforded by being the property of Whites, who considered themselves a superior race.Google Scholar
Orfield, M., “Land Use and Housing Policies to Reduce Concentrated Poverty and Racial Segregation,” Fordham Urban Law Journal 33, no. 3 (2006): 877936.Google Scholar
Institute of Medicine (IOM), Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (Washington, D.C.: The National Academies Press, 2003).Google Scholar
Ahmed, A. T. Mohammed, S. A., and Williams, D. R., “Racial Discrimination & Health: Pathways & Evidence,” Indian Journal of Medical Research 126, no. 4 (2007): 318327; Schulz, A. J. Kannan, S., and Dvonch, J. T. et al., “Social and Physical Environments and Disparities in Risk for Cardiovascular Disease: The Healthy Environments Partnership Conceptual Model,” Environmental Health Perspectives 113, no. 12 (2005): 1817–1825.Google Scholar
Adegbembo, A. O. Tomar, S. L., and Logan, H. L., “Perception of Racism Explains the Difference Between Blacks’ and Whites’ Level of Healthcare Trust,” Ethnicity & Disease 16, no. 4 (2006): 792798.Google Scholar
See Roberts, , supra note 19.Google Scholar
For an example, see Williams, D. R. Mohammed, S. A. Leavell, J., and Collins, C., “Race, Socioeconomic Status, and Health: Complexities, Ongoing Challenges, and Research Opportunities,” Annals of the New York Academy of Sciences 1186 (2010): 69101.CrossRefGoogle Scholar
See Williams, et al., supra note 3.Google Scholar
Steffens, D. C. Artigues, D. L. Ornstein, K. A., and Krishnan, K. R., “A Review of Racial Differences in Geriatric Depression: Implications for Care and Clinical Research,” Journal of the National Medical Association 89, no. 11 (1997): 731736.Google Scholar
Id.; Hamilton, L. A. Aliyu, M. H., and Lyons, P. D. et al., “African-American Community Attitudes and Perceptions toward Schizophrenia and Medical Research: An Exploratory Study,” Journal of the National Medical Association 98, no. 1 (2006): 110.Google Scholar
Faith and spirituality as used by Wittink, et al. referred to faith in God and the power of spirituality and prayer to heal. The article does not name a specific god, nor does it refer to organized religion. Various Pentecostal traditions embrace the view of faith as potentially healing and of the ability to heal – by whatever means (i.e., traditional medical or not) – as a gift from God. See Wittink, et al., supra note 6.Google Scholar
See Wittink, et al., supra note 6; Zimmerman, R. K. Tabbarah, M., and Nowalk, M. P. et al., “Racial Differences in Beliefs About Genetic Screening among Patients at Inner-City Neighborhood Health Centers,” Journal of the National Medical Association 98, no. 3 (2006): 370377.Google Scholar
Brown, C. Conner, K. O., and Copeland, V. C. et al., “Depression Stigma, Race, and Treatment Seeking Behavior and Attitudes,” Journal of Community Psychology 38, no. 3 (2010): 350368; Corrigan, P. Markowitz, F. E. Watson, A. Rowan, D., and Kubiak, M. A., “An Attribution Model of Public Discrimination towards Persons with Mental Illness,” Journal of Health and Social Behaviour 44, no. 2 (2003): 162–179.CrossRefGoogle Scholar
See Brown, et al., supra note 45, at 352.Google Scholar
See Brown, et al., supra note 45; Pallinkas, L. A. Criado, V., and Fuentes, D. et al., “Unmet Needs for Services for Older Adults with Mental Illness: Comparison of Views of Different Stakeholder Groups,” American Journal of Geriatric Psychiatry 15, no. 6 (2007): 530540.Google Scholar
Corrigan, P. W., “How Clinical Diagnosis Might Exacerbate the Stigma of Mental Illness,” Social Work 52, no. 1 (2007): 3139.CrossRefGoogle Scholar
Bartky, S. L., “Unplanned Obsolescence: Some Refections on Aging,” in Walker, M. U., ed., Mother Time (Lanham: Rowman & Littlefield Publishers, Inc., 1999): At 61–74.Google Scholar
Wendell, S., “Old Women out of Control: Some Thoughts on Aging, Ethics, and Psychosomatic Medicine,” in Walker, M. U., ed., Mother Time (Lanham: Rowman & Littlefield Publishers, Inc., 1999): 133149; Silvers, A., “Aging Fairly: Feminist and Disability Perspectives on Intergenerational Justice,” in Walker, M. U., ed., Mother Time (Lanham: Rowman & Littlefield Publishers, Inc., 1999): At 203–226.Google Scholar
Black, H. K. White, T., and Hannum, S. M., “The Lived Experience of Depression in Elderly African American Women,” Journal of Gerontology 62B, no. 6 (2007): S392S398.CrossRefGoogle Scholar
See Hussain-Gambles, et al., supra note 14.Google Scholar
See Palinkas, et al., supra note 47.Google Scholar
Freimuth, V. S. Quinn, S. C., and Thomas, S. B. et al., “African Americans' Views on Research and the Tuskegee Syphilis Study,” Social Science & Medicine 52, no. 5 (2001): 797808; see Hamilton, et al., supra note 42; Corbie-Smith, G. Thomas, S. B. Williams, M. V., and Moody-Ayers, S., “Attitudes and Beliefs of African Americans toward Participation in Medical Research,” Journal of General Internal Medicine 14, no. 9 (1999): 537–546; Farmer, D. F. Jackson, S. A. Camacho, F., and Hall, M. A., “Attitudes of African American and Low Socioeconomic Status White Women toward Medical Research,” Journal of Health Care for the Poor and Underserved 18, no. 1 (2007): 85–99.CrossRefGoogle Scholar
See Zimmerman, et al., supra note 44.Google Scholar
Frazier, L. Calvin, A. O. Mudd, G. T., and Cohen, M. Z., “Understanding of Genetics among Older Adults,” Journal of Nursing Scholarship 38, no. 2 (2006): 126132, at 130.Google Scholar
Buchanan, A. Califano, A., and Kahn, J. et al., “Pharmacogenetics: Ethical Issues and Policy Options,” Kennedy Institute of Ethics Journal 12, no. 1 (2002): 115.CrossRefGoogle Scholar
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.” Burchard, E. G. Ziv, E. Coyle, N., and Gomez, S. L., “The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice,” New England Journal of Medicine 348, no. 12 (2003): 11701175, at 1173.CrossRefGoogle Scholar
Slightly different definitions abound with some commentators abandoning, and others maintaining, a distinction between pharmacogenetics and pharmacogenomics. P-genetics investigates the relationship between individuals’ drug metabolism and genetic polymorphisms, while p-genomics uses genome-wide studies to develop new drugs using information about genetic polymorphisms and gene expression (Morley, K. I. and Hall, W. D., “Using Pharmacogenetics and Pharmacogenomics in the Treatment of Psychiatric Disorders: Some Ethical and Economic Considerations,” Journal of Molecular Medicine 82, no. 1 (2004): 2130). In relation to drug response, p-genetics focuses on genotypic variations that are not tissue-specific, while p-genomics focuses on gene expression in cells of particular tissues (see Buchanan, et al., supra note 57). Because our concerns about research participation apply to both domains, however they are defined, and because our focus is on the eventual clinical use of all such research to reduce health disparities, we employ the term “pharmacogenomics” to refer to the generation and clinical translation of information about genetic variation and treatment response. Rothstein and Epps (Rothstein, M. A. and Epps, P. G., “Pharmacogenomics and the (Ir)relevance of Race,” Pharmacogenomics Journal 1, no. 2 (2001): 104–108) define pharmacogenetics as the study of inherited genetic Influences on drug response, a conception that may resonate negatively with older adults whom Frazier et al. identified as reluctant to participate in genetic research for fear of learning they have passed on a condition to offspring (see supra note 56).CrossRefGoogle Scholar
Some include a fourth phenotype: intermediate metabolism (between slow and rapid). See Poolsup, et al., supra note 9.Google Scholar
Foster, M. W. and Sharp, R. R., “Beyond Race: Towards a Whole-Genome Perspective on Human Populations and Genetic Variation,” Nature Reviews Genetics 5 (2004): 790796, at 792.CrossRefGoogle Scholar
For example, see Tang, H. Quertermous, T., and Rodriguez, B. et al., “Genetic Structure, Self-Identified Race/Ethnicity, and Confounding in Case-Control Association Studies,” American Journal of Human Genetics 76, no. 2 (2005): 268275.CrossRefGoogle Scholar
Bamshad, M., “Genetic Influences on Health: Does Race Matter?” JAMA 294, no. 8 (2005): 937946.CrossRefGoogle Scholar
See Poolsup, et al., supra note 9.Google Scholar
Nanda, R. Schumm, L. P., and Cummings, S. et al., “Genetic Testing in an Ethnically Diverse Cohort of High-Risk Women: A Comparative Analysis of BRCA1 and BRCA2 Mutations in American Families of European and African Ancestry,” JAMA 294, no. 15 (2005): 19251933, at 1925.CrossRefGoogle Scholar
Id., at 1930.Google Scholar
Olopade, O. I. Fackenthal, J. D., and Dunston, G. et al., “Breast Cancer Genetics in African Americans,” Cancer 97, no. 1, Supp. (2003): 236245.CrossRefGoogle Scholar
Tate, S. K. and Goldstein, D. B., “Will Tomorrow's Medicines Work for Everyone?” Nature Genetics 36, no. 11 supplement (2004): S3442.CrossRefGoogle Scholar
This finding has been disputed by other studies and also has been attributed to Differences in clinicians' attitudes and prescribing practices, rather than to African Americans' response to anti-psychotic medications. See Poolsup, et al., supra note 9.Google Scholar
Frackiewicz, E. J. Sramek, J. J. Herrara, J. M. Kurtz, N. M., and Cutler, N. R., “Ethnicity and Antipsychotic Response,” Annals of Pharmacotherapy 31, no. 11 (1997): 13601369.CrossRefGoogle Scholar
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 non-disparate care.Google Scholar
See Williams, et al., supra note 39, at 91.Google Scholar
Griffith, D. M. Mason, M., and Yonas, M. et al., “Dismantling Institutional Racism: Theory and Action,” American Journal of Community Psychology 39, nos. 3–4 (2007): 381392.CrossRefGoogle Scholar
See Williams, et al., supra note 39.Google Scholar
This recommendation is made by Brody with regard to other types of research that affect health disparities. Parker, L. S. and Brody, H., “Comparative Effectiveness Research and Health Reform: Ethical Issues,” Health Progress 92, no. 5 (2011): 6471.Google Scholar
Department of Health and Human Services, HHS Action Plan to Reduce Racial and Ethnic Health Disparities, 2011, at 12, available at <http://minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete.pdf> (last visited December 5, 2012).+(last+visited+December+5,+2012).>Google Scholar
Forrow, L. Arnold, R., and Parker, L. S., “Preventive Ethics: Expanding the Horizons of Clinical Ethics,” Journal of Clinical Ethics 4, no. 4 (1993): 287294.Google Scholar
Wolf, S. M. Lawrenz, F. P., and Nelson, C. A. et al., “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219248.CrossRefGoogle Scholar
Office of Human Research Protections, IRB Guidebook, 1993, available at <http://www.hhs.gov/ohrp/archive/irb/irb_guide-book.htm> (last visited December 5, 2012).+(last+visited+December+5,+2012).>Google Scholar
See Buchanan, et al., supra note 57.Google Scholar
Brody, H. and Hunt, L. M., “BiDil: Assessing a Race-Based Pharmaceutical,” Annals of Family Medicine 4, no. 6 (2006): 556560.CrossRefGoogle Scholar
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. Ellison, G. T. H. Kaufman, J. S. Head, R. F. Martin, P. A., and Kahn, J. D., “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): 449457.Google Scholar
See Ellison, et al., supra note 84.Google Scholar
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, Obasogie, Osagie K., available at <http://www.biopoliticaltimes.org/article.php?id=2018> (last visited December 5, 2012).+(last+visited+December+5,+2012).>Google Scholar
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 of-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.Google Scholar
U.S. Department of Health and Human Services, Pharmacogenomics Knowledge Base, PharmGKB, available at <http://www.pharmgkb.org/resources/forGeneralUsers/pharmacogenetics_pharmacogenomics_anpersonalized_medicine.jsp> (last visited March 9, 2012); also quoted, for example, in Khoon, C. C., Genomics and Population Health: A Social Epidemiology Approach, in Genomics and Bioethics: An Interdisciplinary Perspectives, Technologies, and Advancements, ed. Hongladarom, Soraj (Hershey, PA: Medical Information Science Reference, 2011.)Google Scholar