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01/29/2008

On gene therapy and informed consent

By Alan Milstein

Januarys issue of Human Gene Therapy offers some intriguing commentary on the issue of informed consent in gene transfer trials. I became aware of the articles when a writer for TheScientist Blog called for my reaction to the Editorial by James Wilson, because I had represented the Gelsinger family after the death of their son in the experiment sponsored by Dr. Wilson and because I currently represent the family of Jolie Mohr, whose recent death renewed the debate over the informed consent process in this field of research.

My initial reaction reported by the caller reflects my surprise that Dr. Wilson would thrust himself into the debate when the informed consent process he used during his trial was so deficient.

In the Editorial, Wilson writes:I encourage the professional gene therapy societies and various related foundations to work together in the new year to undertake a critical review of the conduct of our clinical trials… it behooves us to get ahead of this issue and put in place more effective ways to assure that research subjects who courageously give of themselves can do so with a full and unbiased understanding of the risks and benefits of their participation.

The Issue includes commentaries by Art Caplan and Jeffrey Kahn who both question whether subjects in such trials are ever able to understand the mechanism of gene transfer and the risks associated with this nascent technology. Both call for subject advocates to be included in the process so that the human subject has a representative who can understand the risks and benefits of participation and offer advice on whether participation is in his or her best interest. Kahn questions whether the name of the field itself, splattered through the pages of the informed consent documents, misrepresents gene transfer as a proven therapy when, of course, it is not. Caplan laments: very little has changed in the past decade in the way informed consent is obtained from perspective subjects.

Wilson makes no mention of the specific problems in the informed consent process in the Gelsinger experiment but some of the commentators imply they were primarily the inability of an 18 year old subject and his father to understand such complex research. While that certainly was the case, it ignores the failure of Wilson and his team to include in the document the monkey deaths that had occurred in the pre-clinical research, the prior adverse events involving other human subjects in the earlier cohorts, and the extent of the financial stake both Wilson and the University of Pennsylvania had in a successful outcome. These are issues the family could understand without a subject advocate.

What is most troubling is that Wilson has not written an explanation of what really went wrong in the Gelsinger research and what lessons should be learned. Such an article was supposed to be an express condition of the settlement of the claims brought by the government against Wilson and the University of Pennsylvania. At least this was the promise made by the United States Attorney to me and Mr. Gelsinger, a promise as yet still unfulfilled.

Alan C. Milstein is a nationally recognized litigator in the areas of insurance law, products liability, bioethics and clinical trials litigation.

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