Monday, November 24, 2008

In Brugge: The Cure

One of the most striking themes at the European Society of Gene and Cell Therapy was the extent to which continental European researchers conceptualize first-in-human gene transfer experiments as therapeutic interventions rather than research protocols.

Perhaps the most extreme and explicit expression of this was view was presented by Bonn internest Thomas Heinemann (he also studied philosophy and serves on several ethics committees in Germany). Heinemann advanced the notion of the "controlled individual therapeutic attempt," for which the primary objective is therapeutic gain; the scientific dimensions of such studies (e.g. collecting safety data) are necessarily secondary. As he put it, research is only justified "ex post facto."

I found this argument intriguing for several reasons. First, Heinemann justified this claim largely on grounds of autonomy and instrumentalization of desperately ill patients. In contrast, North American bioethicists typically use autonomy and instrumentalization to argue the opposite: that research is primarily intended to serve the ends of others, hence the paramount importance of obtaining consent from volunteers and their guardians, hence the need to be extremely cautious going into a desperately ill population, where autonomy might be compromised.

Second, I was impressed by the speaker's conviction that first-in-human trials have therapeutic warrant. After almost twenty years of painstaking and at times discouraging research, we seem to have learned two things:  first, that first-in-human trials rarely go as expected, and second, that such studies often yield important insights about new interventions. I might have expected a more cautious and seasoned view about the therapeutic merits of first-in-human attempts: does it really enhance the autonomy of volunteers to offer so little by means of therapy, but to foreseeably get so much in terms of social good? (photo credit: virtualais //www.77click.it, Brugge, 2008)

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