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Ethics and Drug Testing in Human Beings
Published online by Cambridge University Press: 08 January 2010
Extract
In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression.
- Type
- Papers
- Information
- Royal Institute of Philosophy Supplements , Volume 22: Moral Philosophy and Contemporary Problems , September 1987 , pp. 199 - 211
- Copyright
- Copyright © The Royal Institute of Philosophy and the contributors 1987
References
1 Irish Times 7/9/84.
2 It could be a remission of sentence, for instance, where the participants were prisoners.
3 Irish Times 7/9/84.
4 See Nowlan, D. in the Irish Times 6/9/84.Google Scholar
5 Irish Times 7/9/84.
6 Byrne, D. in the Irish Times 5/9/84.Google Scholar
7 Under the Irish parliamentary system, the Oireachtas comprises the Senate and the Dail, the latter of which corresponds to the British House of Commons. The Clinical Trials Bill (first promoted in December 1986) has been given a further reading by the current Fianna Fail government, and is highly likely to become law.
8 My own views on this legislation (which I welcome in principle) are published in the Irish Medical Times 23/5/86.
9 Fitzpatrick, M. in the Sunday Independent 23/6/85.Google Scholar
10 Fitzpatrick, M. in the Sunday Independent 23/6/85.Google Scholar
11 However, if a much higher remuneration were introduced, the middle classes might become so interested in volunteering for projects that they would begin to displace those who were economically more marginal. In that case a quota system would have to be introduced.
12 See Nowlan, D., the Irish Times 5/9/84.Google Scholar
13 I emphasize that my concern here is with the intellectual tradition deriving from Mill, and not with Mill's writings themselves. Obviously I would not wish to ascribe to Mill all the features of late twentieth-century liberalism.
14 Mill, (1962) 135.Google Scholar
15 Mill scholars now tend to hold that while Mill was opposed to strong paternalism, he favoured what Ten calls ‘a degree of paternalism’ ((1980) 110)Google Scholar. Weak paternalism is defined by Ten as ‘the doctrine that we are justified in interfering to prevent a person from harming himself only when there is a defect in his decision to engage in the self-harming activity’. Such a defect exists when, for example, the person lacks some relevant knowledge, lacks selfcontrol, or is the victim of undue influence. It is interesting to note that while Mill's favouring weak paternalism is said to be proven by analysis of Mill's arguments and examples, Ten himself does not provide this analysis. Second, if Ten's claim is true, then Mill's principle, in the end, has application only to the perfectly rational, fully informed and psychologically secure individual. But how many human beings fit into this category?
16 See Williams, (1979) 53–8.Google Scholar
17 I am indebted for this information, and for the insights derived from it, to Levy, (1979/1980).Google Scholar
18 But then it would very probably be too late. In Niall Rush's case, as reported at the inquest, the ‘emergency’ lasted one minute, after which he was dead.
19 In more recent interviews Dr Darragh has stressed the confidential nature of the doctor-patient relationship.
20 See the Irish Times 10/9/84.