The company Geron recently decided to stop its unique clinical trial concerning treatment of spinal cord injury with neural cells derived from human embryonic stem cells.
In a previous post on this blog, I used the company’s decision to illustrate a possible consequence of the European ban on stem cell patents requiring the destruction of human embryos. The same day I posted my consideration, Francoise Baylis published a wholly different perspective on Geron’s decision…
Geron claims that the decision to stop the trial was made for business reasons. They wanted to concentrate their limited resources to their oncology drugs. However, the decision left the four research participants that had been enrolled in the trial in a vacuum.
Geron says it will continue to study these participants and report findings. But the trial was originally meant to include ten participants. Will results with only four participants be scientifically valid, Baylis asks. If the results are valid, then using ten participants, as originally planned, would have meant using more patients than required for producing valid results. If results with four participants are not valid, four patients are exposed to risk without any prospects of countervailing new knowledge.
– Which conclusions can be drawn from this example? Should the practices of ethical review be changed for applications from the private sector? Should financial resources and business strategies be included in the issues to consider? That seems to be Baylis’ response to Geron’s decision to quit stem cell research.
For my own part, I think we need more than one example before we consider making ethical review practices even more complex. A more time-consuming process of ethical review has a cost that we need to acknowledge…
As Simon Whitney summarized his views on the expansion of ethical regulation of medical research, “since biomedical research saves lives, it is unsurprising that the regulation of research costs lives.” – It may be unethical to make the process of ethical review even more cumbersome. Patients die when life-saving research is delayed. That cost must be brought into the equation when we consider single examples of ethically problematic conduct that we may wish to regulate against.