With Good Reason A Legal Bombshell Hits Stem Cell Science

Sep 8, 2010

On August 23, Chief federal Judge Royce C. Lamberth of U.S. District Court for the District of Columbia ruled that the Obama administration's guidelines for funding embryonic stem-cell research (which went into effect on July 7, 2009) violate federal law. He then placed a temporary injunction on any further funding.  On Tuesday August 31, the administration filed a motion to stay that decision while a case challenging the funding policy makes its way through the courts.

Lamberth took up the case after a court of appeals determined that plaintiffs James L. Sherley and Theresa Deisher, both adult stem-cell researchers, had standing to challenge the guidelines because these arguably discriminate against scientists seeking stem cell funding for projects that do not involve human embryonic stem cells. In a recent interview with the Wall Street Journal, Deisher explained that, "Any adult stem cell scientist is disadvantaged, and that's because there is a deliberate focus to fund embryonic stem cell research and a focus away from adult stem cell research."  And as Samuel Casey, counsel for the plaintiffs observed in a letter to the editors of the journal Nature, in so ruling:

The court faithfully applied a long line of cases, stretching back to the early 1970s. These consistently held that participants in regulated markets suffer injury when illegal changes in the regulatory scheme alter the competitive landscape  --  in this case, the increased competition for funding to support research on adult (as opposed to embryonic) stem cells.

At the heart of the matter in Lamberth's ruling is the Dickey-Wicker Amendment (DWA) which has been attached to the Health and Human Services appropriations bill every year since 1996. As written, it prohibits federal funding for "the creation of a human embryo or embryos for research purposes; or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under [current federal law]."

For 14 years, DWA has effectively prohibited the use of federal funds to support any research that would directly endanger or destroy human embryos. Beginning in 1999 under the Clinton administration, however, DWA has been interpreted as restricting federal funding only for the research in which human embryos are actually created and destroyed.

Lamberth noted that the defendants in the case were insisting that DWA presupposes this same putative conceptual distinction between: (a) research directly on embryos, and (b) research on hESCs as if the two were wholly distinct research endeavors.  Resting their defense, as did the decade-old legal loophole on a much narrower interpretation of the phrase "research in which," they argued that DWA prohibits funding of the former, but allows funding of the latter.

Lamberth for his part -- in a ruling that is breathtaking in its clarity, absent of any hint of judicial activism -- determined that, on an objective reading of the plain language of DWA, such a distinction is unsustainable:  

[T]he language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed. This prohibition encompasses all "research in which" an embryo is destroyed, not just the "piece of research" in which the embryo is destroyed. Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way. Congress, however, has not written the statute that way, and this Court is bound to apply the law as it is written.

And further:

If one step or "piece of research" of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment.

It comes as no surprise that Reps. Dickey and Wicker, who crafted and sponsored the amendment in the first place, have insisted repeatedly over the years that their amendment was always meant to be read in just this fashion.  Until now that intent had been ignored by the NIH. Those days, it seems, are over, at least until Congress takes steps to enact new legislative remedies to open the funding again -- a step they should consider with extreme caution since a majority of Americans ( 57% according to a new poll) oppose federal funding for hESC research. For over a decade, DWA faithfully reflected a nation's conscience on this issue, a conviction now shared by most. Let's see if Congress gets it.