Clinical Trials Raise New Ethical Concerns

January 11, 2012

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Four years ago, Chris Scott says, it was hard to find any scientists at the annual meeting of the International Society for Stem Cell Research who identified themselves as stem cell biologists. 'People would say, 'I'm a developmental biologist,' or, 'I'm a cell biologist,' but the field was still coalescing, trying to figure out what it was."

This year, sessions were overflowing with researchers eager to proselytize on behalf of stem cell biology. 'The reason is that it transcends so many areas of science—tissue engineering, transplant surgery, immunology, cell biology, genetics," Scott says. 'It touches every corner of biology."

A cell biologist by training, and author of Stem Cell Now (Penguin, 2006), Scott, MLA '05, directs the year-old program in stem cells and society that is part of Stanford's Center for Biomedical Ethics (SCBE). The program educates students, and the public, about stem cell research, hosts conferences and symposia, and consults with policy makers who want to know what's happening in the so-called ELSE issues—ethics, law, society and economics—surrounding that research.

Take medical tourism as an example. A desperate U.S. patient with a back injury travels to a Shanghai clinic, gets several injections of his own stem cells into his spinal cord, plus some physical therapy, and flies home. 'Trials may be carried out in unregulated environments, with no institutional oversight to ensure patient safety," Scott says. 'And some trials are simply 'one-offs.'"

Coming clinical trials in the United States are another 'area of concern" for Scott and his colleagues. 'Here in California, Geron will be the first penguin off the ice floe," he says. The pharmaceutical company plans to use stem cells derived from human embryos for patients who have spinal cord injuries, starting in early 2008. 'Much of the ethical debate has been centered on stem cell research, but now the ethics are turning to patients. The first human trials will be the kind of frontier medicine you can put in the same category as the first gene therapy trials."

The stem cell program coordinates several courses, including one that SCBE director David Magnus, PhD '93, teaches for all scientists receiving funding from the California Institute for Regenerative Medicine. 'He gives them a hard-core introduction to Immanuel Kant and John Stuart Mill, and arms them with philosophical arguments they can use in the public policy arena," Scott says. 'Then, when they are challenged, they can say, 'I do understand the radical Catholic position, but here's a rebuttal to that.'"

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