Monday, December 05, 2011

The Back Story on Baylis and the Ethics of Geron's hESC Trial

Last week Canadian bioethicist Francoise Baylis raised ethical questions about Geron's abandonment of its hESC clinical trial in an article that, it turned out, has a bit of a history.

When we notified her that we had written about her piece and its implications for the California stem cell agency, Baylis replied with a thank you and said,
"As an aside, you might be interested to know that I sought to publish a version of this commentary as a letter to the editor in a peer reviewed stem cell science journal and received the following response: I and two experts 'found the overall tone and presentation of the letter inappropriately strong and confrontational. As a result, it does not seem appropriate for us to offer to consider it further.'

"In my view, this was an unfortunate editorial decision as I believe the stem cell science community needs to engage with this issue. Moreover, I know of responsible stem cell researchers who share my point of view. Beside which, I disagree with the characterization of the piece as confrontational ...

"Another posting of mine on The Mark News makes the same point, but in a more journalistic style."
In that piece, Baylis also wrote about Geron's position that the results with four clinical trial participants would "be a fair reflection of what would have happened if we had completed the study(with 10).” She said,
"I want to suggest, however, that this is an ethically problematic response to a situation that could have been anticipated, and thus avoided. Failure to name the problem in this way leaves future participants in safety studies of novel hESC interventions at risk of abandonment whenever a private biotech company decides to end a trial mid-stream for business reasons."
Our take? The California Stem Cell Report agrees that the decision by the unnamed journal was unfortunate, to put it mildly. Baylis' comments were neither inappropriate nor confrontational, but they did raise questions that could well make some persons uncomfortable. Nonetheless, the questions were the sort that the general public and patient advocates raise in one form or another in their dealings with the enterprises that develop therapies and drugs. Either the questions are addressed now or later -- when they may well have to be dealt with under much more difficult circumstances when things go awry. Sphere: Related Content

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