In hindsight, the issuance of a temporary injunction barring the NIH from funding human embryonic stem cell (hESC) research (by DC District Chief Judge Royce C. Lamberth) should hardly have come as a surprise. After all, many of the same plaintiffs and much of the same legal team have filed a very similar lawsuit a decade earlier. Giving up was not an option. Making good on the premise of "if at first you don't succeed, try, try again," Nightlight Christian Adoptions and like-minded organizations stood at the ready to use legal means to oppose hESC research. As such, this story is about ideological perseverance, an exposed legal flank, congressional inaction, and lackluster advocacy.
Let's start at the beginning. On August 25, 2000, at the tail end of President Clinton's Administration, the NIH issued final guidelines for the funding of research using human pluripotent stem cells. In opposition, plaintiffs led by Nightlight Christian Adoptions (a not-for-profit committed to "advocating to the personhood of pre-born children") commenced a suit in the DC District Court to stop NIH from funding hESC research. Filed on March 8, 2001, Nightlight Christian Adoptions, et al. v. Thompson maintained that public funding of hESC research was unlawful, increased grantee competition for federal funds, and reduced the availability of human embryos for adoption. Co-plaintiffs consisted of the Christian Medical Association (a not-for-profit association of physicians opposed to hESC research), prospective (embryo) "adoptive" parents, and David A. Prentice, PhD (an adult stem cell researcher opposed to hESC research). On May 4, 2001, Judge Lamberth issued a stipulated motion to stay the case while then-President George W. Bush conducted a review of the relevant NIH guidelines. On August 8, 2001, Judge Lamberth proceeded to stay an opposing suit - Thomson v. Thompson - led by stem cell pioneer James A. Thomson, PhD and three patients, including the late actor Christopher D. Reeve. Sounds familiar so far?
Fast forward. On March 9, 2009, President Obama signed an executive order intent on expanding hESC research. Final NIH guidelines to this end followed suit by July 7, 2009. In opposition, yet again, the Nightlight Christian Adoptions team swung into action reinforced by hESC objectors Drs. Sherley and Deisher. On August 19, 2009, Sherley v. Sebelius was filed with the very same DC Court previously entrusted with Nightlight Christian Adoptions, et al. v. Thompson. A few legal two-steps later take us full circle. Having found the plaintiffs to have shown a "likelihood of success on the merits" and a likely "irreparable harm" if a preliminary injunction were not to be granted, Judge Lamberth proceeded to grant the requested preliminary injunction. hESC research has not been the same since. The injunction having been stayed, the case will now meander its way through the courts. We are not likely to see the end of this for some time to come. Déjà vu all over again? Absolutely. You did see this movie before.
Of course, we would be having a very different discussion nary an exposed legal flank, Congressional inaction, and lackluster advocacy. Given the dichotomous interpretation of the Dickey-Wicker Amendment - an annual rider prohibiting NIH from funding "research in which human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death" - a legal challenge was just a matter of time. This was hardly lost on Congressional supporters of hESC research led by Representative Diana DeGette (D-Col) and Senator Tom Harkin (D-IA). In retrospect, they and their allies wish Congress had devoted more energy to moving H.R.4808 and S.487 (Stem Cell Research Enhancement Act of 2009). If passed, these bills would have provided statutory relief by requiring the Secretary of HHS to "conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo." And yes, while last minute advocacy by the Association of American Medical Colleges and by the Coalition for the Advancement of Medical Research were welcome, they were likely too little too late.
Like it or not, the matter of hESC research is not going away any time soon. Sherley v. Sebelius will not be decided for some time, possibly not before early 2011. With an uncertain outcome and so much at stake, one can only hope that hESC advocates will emulate some of the unerring focus displayed by their adversaries while mastering the lessons imparted by a nimble legal insurgency.
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