California Stem Cell Agency and Geron: Ethical Issues with Sale of hESC Trial

A Canadian bioethicist is raising ethical questions about Geron's hESC trial that have implications for the attempt by the California stem cell agency to salvage the once-vaunted effort.

Writing yesterday on the Hastings Center Bioethics Forum, Francoise Baylis of Dalhousie University said,

"It is one thing to close a trial to further enrollment for scientific reasons, such as a problem with trial design, or for ethical reasons, such as an unanticipated serious risk of harm to participants. It is quite another matter to close a trial for business reasons, such as to improve profit margins."

Geron last month said it was ending the trial because of financial reasons and to pursue development of its cancer treatments. CIRM awarded Geron a $25 million loan just last May and was surprised by the Geron move. The $3 billion state research program is now attempting to find a buyer/partner for Geron's hESC business.

Baylis noted that Stephen Kelsey, chief medical officer of the Menlo Park, Ca., firm, has been quoted as saying that the results of Geron trial – now with five patients instead of the projected 10 – "will be a fair reflection of what would have happened if we had completed the study."

Baylis wrote,

"This statement is deeply problematic, however."

Baylis, a professor and the Canada Research Chair in the departments of philosophy and of obstetrics and gynecology at Dalhousie, continued,

"No clinical trial should involve too few or too many participants. It is important that the trial not be underpowered and thus unable to generate scientific knowledge. It is equally important than no more research participants than necessary be exposed to potential research risks. If only five participants were needed to generate the scientific knowledge, then why would Geron and the F.D.A. have agreed to expose additional persons to the potential harms of trial participation?

"On the other hand, if Kelsey’s statement is false, and the findings from five research participants will be underpowered, then they may have been exposed to the potential harms of trial participation without the potential for benefit in the form of scientific knowledge."

She concluded,

"In either case, the scenario forces us to consider what measures should be taken with respect to future trials funded in the private sector so that participants are not left stranded. Perhaps regulators and institutional review boards should critically examine whether a company has both the financial (and other) resources and the will to complete a trial under review before granting regulatory or ethics approval.  If there are doubts about this, then either the trial should not be approved, or there should be stringent disclosure requirements so that prospective research participants are aware of the possibility that research may stop mid-trial for financial reasons."