Exploitation and placebo controls

Exploitation and Developing Countries: The Ethics of Clinical Research

Volumn , Issue , 2008, Pages 246-285

  Hawkins, Jennifer S ^a  

^a NONE

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EID: 78649363530     PISSN: None     EISSN: None     Source Type: Book    
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References (36)

1. AZT is the brand name for the antiretroviral drug zidovudine. A more detailed description of the case appears in the introduction to this volume.
2. H. French, "AIDS Research in Africa: Juggling Risks and Hopes," New York Times, October 9, 1997.
3. Marcia Angell, "The Ethics of Clinical Research in the Third World," New England Journal of Medicine 337 (1997): 847-49;
4. Peter Lurie and Sidney Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries," New England Journal of Medicine 337 (1997): 853-55. These two pieces sparked the debate over the AZT trials.While many other articles have been critical of these trials, they are too numerous to list here.
5. The asterisk is there to remind the reader that "placebo case," as I am using it, only refers to a subset of trials that employ placebo controls. There is a huge general literature on the ethics of placebo-controlled trials, but I am not aiming to engage that entire debate.
6. For detailed descriptions of AZT and Surfaxin, see chapter 2 of this volume.
7. See chapter 1 of this volume for a more in-depth explanation of these trial designs and their typical uses.
8. It is important to emphasize that the first question-whether PCTs are really necessary in a given case-is not a simple one. The question opens up a bitter, on-going methodological dispute that has an important normative component, since in clinical research the degree of methodological rigor we insist upon has real human effects. In real life, many people find it difficult to separate the two questions I outline here.Nonetheless, it is conceptually possible to separate them and morally beneficial to do so.
9. See the discussion of the case by Lurie and Wolfe in Ethical Issues in International Biomedical Research: A Casebook, ed. James V. Lavery, Christine Grady,Elizabeth R.Wahl, and Ezekiel J. Emanuel (New York:Oxford University Press, 2007), 159-70.
10. Alan Wertheimer, Exploitation (Princeton, NJ: Princeton University Press, 1996), 10.
11. All further references to Wertheimer are to this book unless stated otherwise. See also Richard Arneson, "Exploitation," in The Encyclopedia of Ethics, ed. L. C. Becker (New York: Garland Press, 1992), 350.
12. For a theorist who does not accept even this rather general account of exploitation, see Allen Wood, "Exploitation," Social Philosophy and Policy 12 (1995): 135-58.
13. For example, some of the subjects in Nicole's trial very likely did not give fully informed consent (revealing that fact appears to have been the primary journalistic motive for the article in note 1). However, I shall set aside those concerns here.
14. Though see note 29 below about coercion.
15. Wertheimer has also used this case as an example of coercion where the baseline against which threats are distinguished from offers is moralized. Exploitation, at 53. On the relationship between my analysis and coercion, see note 29.
16. See, e.g., Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, "Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits,'" Hastings Center Report 34, no. 3 (2004): 17-27.
17. The relationship need not always be formed by explicit agreement, or by some prior personal engagement between doctor and patient, as long as there are institutional norms that make it clear when one person becomes another's patient.
18. See, e.g., Alison McIntyre, "Guilty Bystanders? On the Legitimacy of Duty to Rescue Statutes," Philosophy and Public Affairs 23 (1994): 157-91;
19. T. M. Scanlon, What We Owe to Each Other (Cambridge, MA: Harvard University Press, 1998), 224 -28;
20. and Joel Feinberg, Harm to Others (Oxford:Oxford University Press, 1984), 126-86.
21. Feinberg notes that although many European countries have instituted laws that penalize people who fail to carry out easy rescues, Anglo-American law has generally not done so. But Anglo-American law does penalize someone in a fiduciary relationship who allows the other party to suffer an easily preventable injury. Hence, Anglo-American law reflects the same distinction I make in the text between two types of positive obligations to help.
22. In this chapter I use "obligation" in the wide sense that carries no implication that if A is morally obligated to do X for B, B has a right against A that A do X.
23. As I use it here, "role overlap" does not refer to the general idea of one person occupying both roles (which remains common), but the more specific idea of occupying both roles in relation to the same person. This is certainly less common than it used to be.
24. I follow Hardimon and Daniels in seeing the role obligations of physicians as contractual: the obligated individual consents to adopt the entire role, even though the specific obligations she acquires form a cluster or group among which she is not free to pick and choose. See M. Hardimon, "Role Obligations," Journal of Philosophy 91 (1994): 333-63;
25. Norman Daniels, "Duty to Treat or Right to Refuse?" Hastings Center Report 21, no. 2 (1991): 36-47.
26. This ought to be qualified a bit.There is room to disagree about whether, even in resource-rich environments, a researcher's obligations are the same as a physician's or simply similar to them (and constrained by them). But I will not pursue the point here.
27. There is much disagreement about when appeals to personal sacrifice can defeat Good Samaritan obligations. A much stronger view than the one I advocate for here is Peter Singer, "Famine,Affluence, and Morality," Philosophy and Public Affairs 1 (1972): 229-43, at 231.
28. Henry Richardson and Leah Belsky also defend the idea that researchers have Good Samaritan obligations-what they call "duties to rescue."
29. H. Richardson and L. Belsky, "The Ancillary Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care That Researchers Owe Their Subjects,"Hastings Center Report 34, no. 1 (2004): 25-33. However, their primary concern is to defend additional positive duties over and above duties to rescue. They neither elaborate on Good Samaritan obligations nor relate them explicitly to placebo-controlled trials.
30. I thank Dan Brock and Dan Wikler for pressing me on this.
31. J. Thomson, "A Defense of Abortion," Philosophy and Public Affairs 1 (1971): 63.
32. See, e.g., C. Snowden, D. Elbourne, and J. Garcia, "Zelen Randomization:Attitudes of Parents Participating in a Neonatal Clinical Trial," Controlled Clinical Trials 20 (1998): 149-71.
33. For more on ancillary care, see Richardson and Belsky, "Ancillary Care Responsibilities." 44. Though see note 38 for a possible second requirement.
34. This is precisely what happened in Surfaxin. After receiving negative publicity about its plans from Ralph Nader's Public Citizen's Health Research Group, the manufacturer abandoned the project and conducted active controlled trials in the United States and Europe instead.
35. This is not mere speculation. Robert Temple of the Food and Drug Administration was quoted as saying, "If they did the trial, half of the people would get surfactant and better perinatal care, and the other half would get better perinatal care. It seems to me that all the people in the trial would have been better off." S. Shah, "Globalizing Clinical Research," Nation, July 1, 2002, 28.
36. "'Bizarre as it may seem to most people,' declared the lead editorial in the New York Times on May 6, 1992, 'many black Americans believe that AIDS and the health measures used against it are part of a conspiracy to wipe out the black race.' . . .The consequences of mistrust were nothing short of tragic. As the Times explained, 'At its most destructive, the paranoia causes many blacks to avoid medical treatment.'" J. Jones, Bad Blood: The Tuskeegee Syphilis Experiment, new and expanded edition (New York: Free Press, 1993), 221.