Distinguishing between Derivation and Use
Casey is among lawyers representing the co-plaintiffs in Sherley v. Sebelius—James L. Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology. In their supplemental brief, Drs. Sherley and Deisher contended: “The federally sponsored hESC research that the guidelines support inevitably creates a substantial risk—indeed, a virtual certainty—that more human embryos will be destroyed in order to derive more hESCs for research purposes.”
That risk, they continued, violates the Dickey-Wicker Amendment of 1996, which says it is illegal to use federal funds for 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.”
Drs. Sherley and Deisher remarked that “each time grant-awarding officials and federally funded scientists support or engage in hESC research, they ‘knowingly subject’ human embryos ‘to risk of injury or death,’ in violation of Dickey-Wicker.”
The co-defendants countered in their supplemental brief that NIH’s guidelines interpret Dickey-Wicker to allow the funding of hESC research but to forbid funding for their derivation. “Plaintiffs’ theory that the guidelines ‘incentivize’ the donation of future embryos casts no doubt on whether NIH had reasonably interpreted Dickey-Wicker, both because future donors would not be engaging in ‘research in which’ an embryo is subject to a risk of injury and because it is not plausible to claim that NIH funded researchers ‘knowingly’ create the incentive for future donation,” HHS and NIH contended.
The court of appeals that disagreed with and reversed Judge Lamberth’s injunction pointed out that it does not unambiguously bar funding for hESC research, “because Dickey-Wicker is written in the present tense, addressing research ‘in which’ embryos ‘are’ destroyed, not research ‘for which’ embryos ‘were destroyed.’”
By that reading, the appeals court continued, NIH must reject a grant application to support research that includes the derivation of stem cells. NIH would not be required, however, to consider the research for which the funds were sought to include “acts or processes such as deriving hESCs that predated the federally funded research.”
Drs. Sherley and Deisher also argued that the NIH guidelines violated both Dickey-Wicker and the Administrative Procedure Act (APA). The co-plaintiffs contended that NIH violated APA when it disregarded and deemed irrelevant roughly 30,000 comments challenging the ethical and scientific merits of hESC research, contending the basic issue of funding hESC research was outside the scope of the rulemaking.
But in his most recent decision, Judge Lamberth ruled that “NIH reasonably interpreted Executive Order 13,505, and operated consistently with both it and the APA’s requirements when it disregarded tens of thousands of public comments,” since the policy question of whether to provide federal funds for hESC research wasn’t at issue.
Judge Lamberth said he was bound by the appeals court decision that Dickey-Wicker could be interpreted to permit funding of hESC research but forbid funding for derivation. “While it may be true that by following the Court of Appeals’ conclusion as to the ambiguity of 'research,' this Court has become a grudging partner in a bout of 'linguistic jujitsu'…such is life for an antepenultimate court,” Judge Lamberth said in his decision.
But as could be expected, the loser in the District Court is expected to appeal to higher courts, all the way to the Supreme Court. Casey and other lawyers representing Drs. Sherley and Deisher said July 27 they were weighing the options for an appeal.
“Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law,” said Steven H. Aden, senior counsel with the Alliance Defense Fund (ADF).