IP Osgoode

Stem Cell Divides

Ivy Tsui is a JD Candidate at Osgoode Hall Law School

On August 23rd, 2010, American human embryonic stem cell (hESC) researchers suddenly found themselves banished from their labs, due to District Court Judge Royce Lamberth‘s issuance of an injunction halting their National Institutes of Health (NIH) funding. The injunction, which led to the suspension of many millions of dollars in funding, was based on the premise that hESC research violates the 1996 Dickey-Wicker Amendment. When considering both sides of the argument, we must bear in mind that the Amendment was passed before hESCs were even isolated (this first happened in 1998), and the therapeutic potential of hESCs had thus yet to be actualized.

ESCs are derived from early embryos that have the capability to differentiate into multiple cell types, holding promises for potentially curing diseases that currently have no treatment options. The first clinical trial of hESC therapy has been approved, for instance, by the Food and Drug Administration (FDA) to treat spinal cord injuries. Under current policy, ESCs must be obtained from leftover embryos that would otherwise be discarded with the donor’s consent. Yet the two plaintiffs that instigated this injunction were actually adult stem cell researchers who claimed hESC research had created unfair competition for researchers working on adult stem cells, which did not involve destroying embryos.

HESC research has always been a controversial political issue. While President Clinton signed the Dickey-Wicker Amendment, President Obama signed an executive order in 2009 which seemingly uncompromisingly encouraged hESC research. Yet Obama left the Amendment on the books, a move some blame for the disorder surrounding the injunction. The injunction, for instance, left it unclear whether scientists are legally allowed to analyze data that had already been generated by hESC cell lines. Researchers in the field have complained that such restrictions place an unbearable emotional and financial burden on them, and caution that younger researchers will be dissuaded from pursuing their interests in the field.

Legal manoeuvrings have come from all quarters: the Coalition for the Advancement of Medical Research (CAMR) submitted a brief challenging the legality of the injunction; on September 7th, Judge Lamberth rejected an appeal filed by the Obama administration asking him to lift the injunction; and finally, on September 10th , an appeals court lifted the ban for an undetermined period, temporarily allowing for the resumption of hESC research. The fact that the legal struggle is taking place in an election year ensures that the issue is unlikely to be neatly resolved.

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