April 28, 2012

Legal Challenge to NIH Funding of Stem Cell Research Continues

The ongoing litigation that challenges the Obama administration policy on the funding of human embryonic stem cell (hESC) research continues this week, as the Court of Appeals for the D.C. Circuit heard arguments in the case. The debate over such funding occurs against the backdrop of the long-existing Dickey Wicker amendment which prohibits the use of federal funds for any research in which an embryo is destroyed. The lawsuit against NIH, brought by several adult stem cell researchers, allege that the federal funding sponsored by the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) violates this existing funding prohibition. This funding followed the 2009 Obama Executive Order, which ended the Bush-era hESC funding ban. The current NIH Stem Cell Guidelines make note of the Dickey-Wicker funding restrictions, but reach the conclusion that its funding of hESC research does not violate them: "These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which federal funding is permitted." The guidelines dictate the proper sources for hESC: “hESCs derived from embryos created using in vitro fertilization (IVF) for reproductive purposes and no longer needed for these purposes, assuming the research has scientific merit and the embryos were donated after proper informed consent was obtained from the donor(s).” Thus, NIH is not endorsing the creation of embryos for the purpose of deriving embryonic stem cells, noting that “additional sources of human pluripotent stem cells proposed by the respondents involve complex ethical and scientific issues on which a similar consensus has not emerged.” An amicus brief filed by Coalition for the Advancement of Medical Research (composed of hospitals, universities, and patient advocates) and the Genetics Policy Institute, Inc., urged the court to rule for the legality of the NIH policy. No doubt, more uncertainty over the legal status of hESC research continues the climate of instability in which this research has been conducted, at least since the 2001 Bush administration policy that halted the use of federal funds for the creation of any new hESC stem cell lines. This policy was reversed in 2009 by President Obama, but the current litigation poses a direct challenge to its legality. Nonetheless, in the torturous route this litigation has taken, the fact that, in 2011, the D.C. Circuit had earlier declined to uphold a 2010 preliminary injunction against NIH (partly because of its view of the weakness of the plaintiffs’ case against NIH) would seem to indicate that the court will uphold the legality of the NIH funding policy. Nonetheless, hESC research is a political issue that will be affected by the outcome of the 2012 presidential race; the NIH funding policy is politically dependent on which political party controls the executive branch.

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