Pharmacogenetics, race and global injustice

Developing World Bioethics

Volumn 8, Issue 2, 2008, Pages 82-88

  Holm, Søren ^a  

^a CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

Global injustice; Pharmacogenetics; Race

Indexed keywords

HYDRALAZINE; ISOSORBIDE DINITRATE; ISOSORBIDE HYDRALAZINE COMBINATION; ISOSORBIDE-HYDRALAZINE COMBINATION;

AFRICAN AMERICAN; ARTICLE; DEVELOPING COUNTRY; DRUG COMBINATION; FOOD AND DRUG ADMINISTRATION; GENETICS; HEALTH CARE DELIVERY; HEART FAILURE; HUMAN; INTERNATIONAL COOPERATION; METABOLISM; PHARMACOGENETICS; RACE; SOCIAL JUSTICE; STANDARD; UNITED STATES;

AFRICAN AMERICANS; CONTINENTAL POPULATION GROUPS; DELIVERY OF HEALTH CARE; DEVELOPING COUNTRIES; DRUG COMBINATIONS; HEART FAILURE; HUMANS; HYDRALAZINE; INTERNATIONALITY; ISOSORBIDE DINITRATE; PHARMACOGENETICS; SOCIAL JUSTICE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 48249140667     PISSN: 14718731     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1471-8847.2006.00173.x     Document Type: Article

References (51)

1. I have previously discussed related issues in S. Holm. 2006. Pharmacogenetics and Global (In)justice. In The Power of Pills: Social, Ethical, and Legal Issues in Drug Development, Marketing, and Pricing, J.C. Cohen, P. Illingworth & U. Schüklenk, eds. London: Pluto Press. In that chapter, I primarily discuss the effects of pharmacogenetics on the development of new molecular entities and how the regulation of pharmacogenetics in resource rich countries will affect the eventual 'trickle down' of drugs that are out of patent. Parts of the introductory explanation of pharmacogenetics in the present paper have been adapted from this previous chapter.
2. US Food and Drug Administration (FDA). 2005. FDA Approves BiDil Heart Failure Drug for Black Patients. Rockville, MD: FDA. Press Release, 23 June. Available at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01190.html [Accessed 29 Aug 2006]. My emphasis.
3. Racially targeted treatment has occurred previously, such as the treatment for 'Drapetomania', the disease that makes slaves run away from their masters. H.T. Engelhardt. 1974. The Concepts of Health and Disease. In Evaluation and Explanation in the Biomedical Sciences. H.T. Engelhardt & S. Spicker, eds. Dordrecht: Reidel: 125-141.
4. Before hailing BiDil and pharmacogenetics as a success for racial equality we might, however, consider what the response should be when the FDA approves the first drug specifically targeting self-identified whites. An in-depth discussion of the scientific aspects of the BiDil case can be found in an exchange in the journal Circulation 2005; 112: 3654-3666. Although the approval of BiDil has been linked to pharmacogenetics in the media and by the FDA, no actual pharmacogenetic testing was involved in the BiDil trials.
5. It is, however, worth noting that BiDil has not been a commercial success because it is seen as a low-priority drug by many US health insurers.
6. It has never been shown conclusively that BiDil works better in African Americans than in other races, just that it works in self-identified African Americans. This was enough to gain market authorisation and market exclusivity.
7. A.S. Daar & P.A. Singer. Pharmacogenetics and Geographical Ancestry: Implications for Drug Development and Global Health. Nat Rev Genet 2004; 6: 241-246.
8. Ibid.
9. I have benefited enormously from reading: T. Duster. 2005. Medicine - Race and Reification in Science. Science 2005; 307: 1050-1051; A.
10. Fausto-Sterling. Refashioning Race: DNA and the Politics of Health Care. Differences 2004; 15(3): 1-37;
11. N. Krieger. Stormy Weather: Race, Gene Expression, and the Science of Health Disparities. Am J Public Health 2005; 95: 2155-2160;
12. S.S. Lee. Race, Distributive Justice and the Promise of Pharmacogenomics: Ethical Considerations. Am J Pharmacogenomics 2003; 3: 385-392;
13. E. Lillquist & C.A. Sullivan. The Law and Genetics of Racial Profiling in Medicine. Harv Civ Rights-Civil Lib Law Rev 2004; 39: 391-483;
14. A. Smart, P. Martin & M. Parker. Tailored Medicine: Whom will it Fit? The Ethics of Patient and Disease Stratification. Bioethics 2004; 18: 322-343;
15. S.K. Tate & D.B. Goldstein. Will Tomorrow's Medicines Work for Everyone? Nat Genet 2004; 36(11 Suppl): S34-42;
16. D.C. Wertz. Ethical, Social and Legal Issues in Pharmacogenomics. Pharmacogenomics J 2003; 3: 194-196.
17. M. Ingelman-Sundberg. Pharmacogenetics: An Opportunity for a Safer and More Efficient Pharmacotherapy. J Intern Med 2001; 250: 186-200: 186.
18. Ibid;
19. Nuffield Council on Bioethics. 2003. Pharmacogenetics: Ethical Issues. London: Nuffield Council on Bioethics.
20. Roche Diagnostics. 2005. Roche's Amplichip Cyp450 test receives FDA clearance. Basel: Roche. Press release, 12 January. The €400 does not include the capital investment in the machine needed to read and interpret the DNA chip, or the cost of preparing the blood sample for testing.
21. See, for instance, the price list at http://www.pgxlab.com/clinician/ price_list.php [Accessed 29 Aug 2006].
22. Nuffield Council on Bioethics, op. cit. note 11.
23. To dispel the idea that pharmacogenetics is something completely novel and exotic, it is worth noting that the universal matching of blood before blood transfusions is actually a pharmacogenetic test: testing a 100% genetically determined trait, and performed to prevent the catastrophic adverse effects of transfusing unmatched blood.
24. P.P. Rioux. Clinical Trials in Pharmacogenetics and Pharmacogenomics: Methods and Applications. Am J Health-Syst Pharm 2000; 57: 887-901;
25. C.R. Wolf, G. Smith & R.L. Smith. Pharmacogenetics. BMJ 2000; 320: 987-990.
26. C.G. Sullivan. How Personalized Medicine is Changing the Rules of Drug Life Exclusivity. Pharmacogenomics 2004; 5: 429-432.
27. US Food and Drug Administration (FDA). 2005. Guidance for Industry - Pharmacogenomic Data Submissions (with attachments). Rockville, MD: FDA.
28. World Trade Organization (WTO). 2001. Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC2), 20 November. Geneva: WTO.
29. On the more general problematic effects of the TRIPS Agreement on the supply of pharmaceutical products in low-income countries, see: S. Holm. Three Reasons why a Global Market in Pharmaceutical Products is Inherently Unjust. J Soc Philos 2000; 3: 391-400;
30. M.A. Oliveira et al. Has the Implementation of the TRIPS Agreement in Latin America and the Caribbean Produced Intellectual Property Legislation that Favours Public Health? Bull World Health Organ 2004; 82: 815-821;
31. S. Sterckx. Patents and Access to Drugs in Developing Countries: An Ethical Analysis. Developing World Bioeth 2004; 4: 58-75.
32. World Trade Organization, ibid, paragraph 4.
33. Ibid: paragraph 6.
34. P.C. Taylor. 2004. Race - A Philosophical Introduction. Cambridge: Polity Press.
35. I would, for instance, be classified as 'White-other', whereas I would want to be classified as 'Danish' or, at least, 'White-Danish'.
36. J.S. Barnholtz-Sloan et al. Examining Population Stratification via Individual Ancestry Estimates versus Self-reported Race. Cancer Epidemiol Biomarkers Prev 2005; 14: 1545-1551;
37. T.R. Rebbeck & P. Sankar. Ethnicity, Ancestry, and Race in Molecular Epidemiologic Research. Cancer Epidemiol Biomarkers Prev 2005; 14: 2467-2471;
38. J.F. Wilson et al. Population Genetic Structure of Variable Drug Response. Nat Genet 2001; 29: 265-269. Apart from the differences outlined in these papers, there are also some differences that have been known for decades: for example, differences in adult lactose tolerance (relevant here because lactose is often used as a 'filler' in tablets and pharmacogenetics covers all aspects of pharmacology, not only the active substance) and the previously mentioned differences in Codeine metabolism.
39. D.W. Nebert & A.G. Menon. Pharmacogenomics, Ethnicity, and Susceptibility Genes. Pharmacogenomics J 2001; 1: 19-22;
40. E.J. Parra et al. Estimating African American Admixture Proportions by Use of Population-specific Alleles. Am J Hum Genet 1998; 63: 1839-1851.
41. F.C. Parra et al. Color and Genomic Ancestry in Brazilians. Proc Natl Acad Sci U S A 2003; 100: 177-182.
42. Wilson et al., op. cit. note 23.
43. N.A. Rosenberg et al. Genetic Structure of Human Populations. Science 2002; 298: 2381-2385.
44. This could - problematically - be the case if the chances of getting redress for serious adverse effects are much less in low income countries.
45. In some cases it will be true that the average wealth in cities is not higher than in rural areas, but this will be, in most cases, because a large number of very poor people living in slums masks the presence of a considerable number of relatively wealthy people. Similarity of average wealth between rural and urban areas does, therefore, not necessarily contradict the argument put forward here.
46. Smart et al., op. cit. note 9. I am not implying that all small indigenous groups should count as racial groups, although some of them clearly do.
47. It is of course possible that new technological developments will make pharmacogenetic testing very inexpensive in the future, but, whereas we can at present predict that the price will fall, it is unlikely that pharmacogenetic testing will become very cheap anytime soon.
48. T.W. Pogge. Human Rights and Global Health: A Research Program. Metaphilosophy 2005; 36: 182-209;
49. P. Singer. Famine, Affluence and Morality. Philos Public Aff 1972; 1: 229-243;
50. P. Unger. 1996. Living High an Letting Die. Oxford: Oxford University Press.
51. Stating that these differences are accepted is not the same as stating that they are acceptable or justified. It is just a statement of fact about a given society.