Stem Cell Trials – Should They Go Ahead? Why Harm to Patients Is Not a Reason to Stop Them

Professor Savulescu comments:

Professor Julian Savulescu is Uehiro Chair in Practical Ethics and Director of the Uehiro Centre for Practical Ethics at Oxford, Director of the Oxford Centre for Neuroethics, and Director of the Program on the Ethics of the New Biosciences. He was also recently awarded a major Arts and Humanities Research Council grant on Cognitive Science and Religious Conflict.


THE FDA has approved for the first time a clinical trial of embryonic stem cells to treat spinal injury patients. The trial will be conducted by Geron. A similar trial by Reneuron has been approved recently in the UK (The Scotsman, and the BBC). The research in the UK to treat stroke patients has already attracted stern criticism from “ethical campaigners.” The first wave predictably objected on the ground that it involved abortion "It involves cannibalising an unborn child.” But no child was aborted for the purposes of providing stem cells. These would have involved abortions that would anyway have occurred for a variety of reasons. Such opponents predictably object to anything involving destruction of embryos and fetuses – abortion, IVF, prenatal testing, contraception – so it is hardly surprising that they would object to this form of medical treatment.

The second wave of ethical campaigners, not clearly distinct from the first, claim now that the treatment is too risky. But is it too risky?

People do die in such clinical trials. Jesse Gelsinger was a young man who died in a similar experiment using gene therapy (Savulescu, J. (2001). "Harm, Ethics Committees and the Gene Therapy Death." Journal of Medical Ethics 27: 148 – 150.)

And a number of people were seriously harmed in a trial at Northwick Park in the UK a few years ago. It is possible, even if remotely possible, that people will die in this trial. Is that a reason to stop it?

Risk of death, sadly, is unavoidable. Every activity carries a risk of death. One famous Greek died eating grape. These patients could die going to see their doctor – in a car accident. Medical trials by their very nature entail some risk. The critical question is not whether there is a risk, but whether the risk is reasonable.

I have written on this topic  (Savulescu, J. (2001). "Harm, Ethics Committees and the Gene Therapy Death." Journal of Medical Ethics 27: 148 – 150.); Savulescu, J. (1998). "Safety of Participants of Non-Therapeutic Research Must be Ensured." British Medical Journal 16: 891 – 892.). In determining whether the risks of participation in research are reasonable, the following factors are relevant:

1.  Is there a known risk to participants prior to commencing the study and what is its magnitude, based on evidence available at the time?

2.  Should any non-human or epidemiological research, systematic overview or computer modelling have been performed prior to the study to better estimate the risk to participants or obviate the need for the use of human participants?

3.  Could the risk have been reduced in any other way? Is it as small as possible?

4.  Are the potential benefits (in terms of knowledge, improvement of welfare of trial participants or other people) of this study worth the risks?

5. Could this research generate knowledge which is likely to significantly harm either participants or others outside the research, now or in the future?

In addition to the risk being reasonable, these people be properly informed of the risks, including death, and the benefits, or likely lack thereof. We should not gloss over the risks inherent in novel therapies. But likewise we should not be paternalistic and deny people the opportunity to choose to take part in valuable research.

Provided people properly appreciated the benefits and risks, and those risks are reasonable, such trials must go ahead to advance knowledge and treatment. People will inevitably be harmed and perhaps even die. But people should be allowed to take on a reasonable chance of dying for a worthwhile goal.

 

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