Friday, January 19, 2007

Clinical Trials (Useful Info)

Those who have been following my blog over the past few months know that I have been predominately preoccupied with the issue of genetics and justice.

In order to develop a useful normative framework for addressing the myriad of concerns which arise out of the genetic revolution, normative theorists must have an appreciation of the empirical realities that face the aspiration to directly mitigate genetic disadvantage. So normative theorists must have an *informed* view concerning where the science actually is, where it might take us in the next few decades, and the kinds of obstacles and challenges facing the aspiration to develop safe and effective treatments for genetic disadvantage.

Suppose, for example, a report comes out (as frequently occurs and I sometimes link to such stories) that a novel gene therapy has proved successful in treating mice for a particular disease. How do we go from treating mice to treating human beings for these same diseases? Not only are human beings biologically different than mice (though we are much more similar than one might have thought, hence the importance of the mouse genome) but there are a range of ethical concerns that arise in the context of conducting experimental therapies on human beings that do not arise in the case of testing on mice. These kinds of concerns are important if one wishes to develop, as I hope to, an informed theory of genetic justice. Concerns about safety and informed consent, etc. complicate the story of how stringent the duty to directly mitigate different kinds of genetic disadvantage is.

To help illustrate the complexity of these kinds of concerns I thought it would be useful to note this informative website which I happened to come across while looking up information on gene therapies for cancer. It is the website of the M. D. Anderson Cancer Center at the University of Texas. And it contains a wealth of useful information about clinical trials for cancer, why they are important, and how these trials progress through different phases to test the safety and efficacy of novel treatments for cancer.

More details concerning clinical trials more generally are available from the Clinicaltrialsgov web site here.

Appreciating the diverse concerns that arise with respect to clinical trials for gene therapies is essential if one wishes to develop a normative theory that takes the duty to prevent harm seriously. The empirical realities of our biology, and limited knowledge, scarcity, indeterminacy, etc. must inform the normative principles and theories we champion.