Stem-cell battles: Stem-cell research in the USA is facing …

Disputes over stem-cell research have been standard operating procedure since James Thompson and John Gearhart created the first human embryonic cell (hESC) lines. Their work triggered an intense and ongoing debate about the morality, legality and politics of using hESCs for biomedical research. Stem-cell policy has caused craziness all over the world. It is a never-ending, irresolvable battle about the moral status [of embryos], commented Timothy Caulfield, research director of the Health Law Institute at the University of Alberta in Edmonton, Canada. We're getting to an interesting time in history where science is playing a bigger and bigger part in our lives, and it's becoming more controversial because it's becoming more powerful. We need to make some interesting choices about how we decide what kind of scientific inquiry can go forward and what can't go forward.

Stem-cell policy has caused craziness all over the world[i]t is a never-ending, irresolvable battle about the moral status [of embryos]

The most contested battleground for stem-cell research has been the USA, since President George W. Bush banned federal funding for research that uses hESCs. His successor, Barack Obama, eventually reversed the ban, but a pending lawsuit and the November congressional elections have once again thrown the field into jeopardy.

Three days after the election, the deans of US medical schools, chiefs of US hospitals and heads of leading scientific organizations sent letters to both the House of Representatives and the Senate urging them to pass the Stem Cell Research Advancement Act when they come back into session. The implication was to pass legislation now, while the Democrats were still the majority. Republicans, boosted in the election by the emerging fiscally conservative Tea Party movement, will be the majority in the House from January, changing the political climate. The Republicans also cut into the Democratic majority in the Senate.

Policies and laws to regulate stem-cell research vary between countries. Italy, for example, does not allow the destruction of an embryo to generate stem-cell lines, but it does allow research on such cells if they are imported. Nevertheless, the Italian government deliberately excluded funding for projects using hESCs from its 2009 call for proposals for stem-cell research. In the face of legislative vacuums, this October, Science Foundation Ireland and the Health Research Board in Ireland decided to not consider grant applications for projects involving hESC lines. The UK is at the other end of the scale; it has legalized both research with and the generation of stem-cell lines, albeit under the strict regulation by the independent Human Fertility and Embryology Authority. As Caulfield commented, the UK is ironically viewed as one of the most permissive [on stem-cell policy], but is perceived as one of the most bureaucratic.

Somewhere in the middle is Germany, where scientists are allowed to use several approved cell lines, but any research that leads to the destruction of an embryo is illegal. Josephine Johnston, director of research operations at the Hastings Center in Garrison, NY, USAa bioethics centresaid: In Germany you can do research on embryonic stem-cells, but you can't take the cells out of the embryo. So, they import their cells from outside of Germany and to me, that's basically outsourcing the bit that you find difficult as a nation. It doesn't make a lot of sense ethically.

Despite the public debates and lack of federal support, Johnson noted that the USA continues to lead the world in the field. [Opposition] hasn't killed stem-cell research in the United States, but it definitely is a headache, she said. In October, physicians at the Shepherd Center, a spinal cord and brain injury rehabilitation hospital and clinical research centre in Atlanta, GA, USA, began to treat the first patient with hESCs. This is part of a clinical trial to test a stem-cell-based therapy for spinal cord injury, which was developed by the US biotechnology company Geron from surplus embryos from in vitro fertilization.

Nevertheless, the debate in the USA, where various branches of governmentexecutive, legislative and legalweigh in on the legal system, is becoming confusing. We're never going to have consensus [on the moral status of fetuses] and any time that stem-cell research becomes tied to that debate, there's going to be policy uncertainty, Caulfield said. That's what's happened again in the United States.

Johnson commented that what makes the USA different is the rules about federally funded and non-federally funded research. It isn't much discussed within the United States, but it's a really dramatic difference to an outsider, she said. She pointed out that, by contrast, in other countries the rules for stem-cell research apply across the board.

The election of Barack Obama as US President triggered the latest bout of uncertainty. The science community welcomed him with open arms; after all, he supports doubling the budget of the National Institutes of Health (NIH) over the next ten years and dismantled the policies of his predecessor that barred it from funding projects beyond the 60 extant hESC linesonly 21 of which were viable. Obama also called on Congress to provide legal backing and funding for the research.

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Stem-cell battles: Stem-cell research in the USA is facing ...