Law, ethics, religion, and clinical translation in the 21st century.

The intersection of values, attitudes, and potential collide uncomfortably when science and society grapple with the issues of personhood, medical developments of significance to the community, and politics responding to a variety of inputs from the legal and ethical perspectives. This has happened before, and I was personally immersed in the debates and traumas of establishing in vitro fertilization (IVF) as a medical therapy for infertility and inherited genetic disease, as a scientist responding to patients’ needs. In many respects, the debates and disagreements that surround embryonic stem cells (ESCs) are primarily similar to that of IVF, except the potential benefits may have life saving or quality of life opportunities that are even more profound and desired by patients and the community, in general. My own ethics were constructed around an Anglican upbringing, skepticism of many religious values as a consequence of education as a scientist, discussions with academic Catholic members of the Vatican University, the utilitarianism philosophy of Peter Singer of Princeton University (when he was a colleague at Monash University), and many friends and opponents from the legal, religious, and political communities. In the end, I am a supporter for providing medical benefit to the community in the most efficient and least risk manner and with as much consideration of competing values of others as is possible to allow the potential opportunity of medical benefit to be demonstrated. I cannot see the merit of disposing of excess human IVF (preimplantation) embryos when ESCs can be derived for research to potentially treat a very wide range of conditions that have no other option. Hence, I do not consider a ball of around a hundred human cells in a dish as equivalent in rights to a fully developed human fetus or born baby capable of independent survival. In fact, I recognize a gradient of value during development and this provides me with a personal ethic that can support among other matters; the ‘‘morning after’’ pill, intrauterine device, and a woman’s right to decide on abortion. Inevitably, these basic tenants will have to be considered by the participants in this series. The moral and ethical issues will have to be balanced with the potential benefits of stem cell research, made uncomfortable because the clinical benefits have still to be adequately demonstrated. The issue of adult stem cell therapies providing all the potential of embryonic stem cells is now really behind us as a non-issue, but still the extent to which ESCs can fill the great gaps left by deficiencies of adult cells is simply unknown. The new induced pluripotential stem (iPS) cells are carving a new frontier of opportunity to interrogate human disease (disease in a dish), demonstrate the heterogeneity of human diseases, and provide a platform for personalized medicine. They may also be useful in cell and gene therapy because of their likely compatibility for transplantation to the original somatic cell donor. The question that is continually asked is: is this the end of a need for ESCs? Scientists are firm in their belief that ESCs are the ‘‘gold standard’’ for pluirpotent stem cells and will remain necessary and clinically useful. Time will tell if this is correct, but given the knowledge at the present time and the clinical trials that are imminent, this view seems appropriate. Clinical trials are about to begin for spinal cord injury, dry macular degeneration, amyotrophic lateral sclerosis (ALS), stroke, and a raft of other indications (see www.cirm.ca.gov) using ESCs. The translational pipeline is filling up, and soon, we shall have further evidence of therapeutic potential. The participants will provide some interesting perspectives of this new and potentially powerful new medicine. Interestingly, it appears that frequently cell and gene therapy will be combined to hopefully achieve the remarkable outcomes that were difficult to obtain using viral vector approaches.