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August 26, 2010

New law may be the only way out for researchers affected by US stem cell injunction

by Ubaka Ogbogu

On August 23, 2010, United States federal district judge Royce C. Lamberth issued a preliminary injunction that overturned President Obama's recent reform of US federal policy on human embryonic stem cell (hESC) research. The injunction -- which will remain in effect until a permanent order is issued upon final determination of the merits of the case -- temporarily shuts down federal funding for all research involving the destruction of human embryos (or more to the point, all research based on materials derived from destroyed embryos, or traceable to a process involving the destruction of embryos). This means that unless and until the injunction is overturned, federal funds can no longer be used to support stem cell derivation from human embryos, or the research use of stem cells derived from human embryos, and that labs currently undertaking hESC research with federal monies would either have to stop their experiments, seek and obtain private funding to continue their research, or move to jurisdictions that support hESC research. The ruling is thus potentially more restrictive than President George W. Bush's policy, which allowed funding for research using hESC lines already in existence by August 9, 2001.

Below, I provide a primer on US federal policy on hESC research for those readers who are not familiar with the subject, followed by a breakdown of the Lamberth decision.

U.S. Federal Policy on HESC Research

  • In the US, there are no federal laws directly regulating hESC research (as exists in Canada, for example). Instead, federal policy is based on the so-called Dickey-Wicker Amendment, a rider to federal spending legislation which prohibits the use of federal funds for creation of human embryos for research purposes or for research in which human embryos are "destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero." In effect, states can set their own policies, and researchers could seek and obtain private funds to conduct research affected by the policy.
  • Since 1999, successive US governments have interpreted the Dickey-Wicker Amendment as stating that federal funds cannot be used to support research on embryos, including derivation of hESC lines for research purposes, since this process involves the destruction of embryos. Beyond this clear rule, the application of the Amendment to research on hESC lines has been based on a clever but (in my opinion and Justice Lamberth's) erroneous interpretation, which holds that since hESC lines are not embryos, the Amendment does not apply, and as such, federal funds could be allocated for research on the lines.
  • In line with this interpretation, President Bush announced a funding policy that allowed the use of federal funds only for research on hESC lines created on or prior to the date his policy took effect. On March 9, 2009, President Obama issued an executive order that removed Bush's restrictions and paved the way for a new policy that broadened the provision of federal funding to include research on hESC lines derived from supernumerary IVF embryos created for reproductive purposes.
  • While a significant improvement on the Bush era policy, Obama's policy was modest at best. It failed to bring US policy in step with research policy in other jurisdictions such as the United Kingdom, Singapore, and the State of California, where various derivation methods are allowed, including the creation of embryos specifically for stem cell derivation purposes. More significantly, the policy was never put forward for or backed by legislative sanction, making it vulnerable to judicial challenge on the basis that it violates the higher-ranked Dickey-Wicker Amendment.

The Lamberth Decision

  • The case involves a motion for preliminary injunction brought by a group of plaintiffs led by two adult stem cell researchers who claimed that allowing federal funding for hESC research violates the Dickey-Wicker Amendment and places them at an irreversible disadvantage of facing increased competition for NIHís limited resources. As is typical of the symbolism often surrounding the debate over embryo research, "Embryos" are one of the named plaintiffs in the case.
  • On the violation issue, the judge agreed with the plaintiffs that the language of the Amendment clearly prohibits the use of federal funds for all research in which a human embryo is destroyed. The judge rejected the governmentís argument that the Amendment supported the interpretation that research hESC is not research on embryos but a separate and distinct "piece of research".
  • Having concluded that the government's interpretation is contrary to law, the judge agreed with the plaintiffs that it was necessary to grant them a preliminary injunction because (a) their case likely to succeed on the merits following a full hearing and final determination; (b) they would suffer irreparable harm from increased competition for limited NIH funding, especially since no compensation could redress that harm if NIH were to disburse limited research funds to hESC research on the basis of a policy that violates the law; (c) the hardship they would suffer if the injunction were denied (increased competition and potential threats to their means of livelihood) was greater than that facing hESC researchers (as the injunction would simply preserve the existing state of affairs) or individuals who could benefit from therapies resulting from the research (which were still speculative); and (d) it is in the public interest to grant the injunction that would implement the law as contained in the Dickey-Wicker Amendment.

From both a technical legal perspective and with respect to the existing US federal policy on hESC research, the judge's decision makes sense. Basing policy on clever but misguided legal interpretations is disingenuous at best. Also, if President Obama and the Democrat-controlled Congress are really serious about supporting, in the Presidentís words, "responsible, scientifically worthy human stem cell research, including human embryonic stem research, to the extent permitted by law," the courageous and proper thing to do would be to remove the Dickey-Wicker restrictions by enacting both the alternative interpretation and other scientifically informed and ethically responsible embryo research methods into law. While I am not completely persuaded that the plaintiffs' "increased competition" claim is real or imminent -- NIH typically put out distinct calls for both areas of research and there's nothing to suggest that the calls disproportionately prioritize or favour hESC research proposal -- the fact remains that US law currently prohibits federal funding for embryo research.   

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