Shocking Stem Cell Decision

Yesterday’s opinion by District Court Judge Royce Lamberth enjoining federal funding of human embryonic stem cell (hESC) research sent shockwaves throughout the medical research community. As usual in this area, the implications of the decision, rather than the legal analysis, is getting all the air time. I’ll discuss the statutory interpretation issue on which the case turns.

The legal issue is the proper interpretation of the Dickey-Wicker Amendment, an obscure provision attached by Congress to omnibus appropriation bills every year since 1996. The amendment prohibits the use of federal money for scientific “research in which … embryos are destroyed, discarded, or knowingly subject to risk of injury or death….” The Clinton, Bush, and Obama administrations have all interpreted this language to mean that the NIH may not fund the creation of embryonic stem cell lines, a procedure that destroys a 5-day old donor embryo (known as a blastocyst) by removing its inner cell mass. The conventional wisdom has always been that Dickey-Wicker does not speak to the question of federal funding of research on hESC lines themselves. These hESC lines, once created, replicate themselves, and the cells are shipped by the institutions that manage them to researchers around the world. The distinction matters a lot, because creating hESC lines isn’t all that hard or all that expensive, relatively speaking, and researchers don’t need a huge number of cell lines to work with. It is not much a problem to rely solely on private funding to create these research materials. What costs hundreds of millions of dollars, and requires substantial federal support, is funding the thousands of scientists who use hESC lines to study human development and search for cures for a range of disabling illnesses and conditions. The Bush Administration largely refused to provide this funding, but it did not believe it was so constrained by Dickey-Wicker. By Executive Order, Obama allowed NIH funding of hESC research, with the qualification that the hESC lines funded must come from excess IVF embryos that would have been destroyed even if not used to create cell lines.

Judge Lamberth surprisingly interpreted Dickey-Wicker to prevent the use of tax dollars to support researchers who do any work using hESC lines as an input. One might at least plausibly argue for this result based on the principle that underlies Dickey-Wicker: that is, if Congress’ goal is to avoid dirtying the federal government’s hands with complicity in the destruction of embryos, perhaps research that relies on embryo destruction somewhere upstream should be ineligible for funding. But Lamberth claims that his result is supported by the unambiguous language of the Amendment. I find this argument utterly unconvincing.

Lamberth’s focus is on the word “research.” First, he relies on regulatory and dictionary definitions to establish that research is a “systematic investigation.” So far, so good. But from this he concludes that any research that relies on upstream embryo destruction is part of the same “project” as the destructive activity itself and therefore ineligible for federal funding. The conclusion simply doesn’t follow from the premise.

The key language here is not the word “research,” but rather the phrase “in which.” That is, Dickey-Wicker does not prohibit federal funding of research that is “related to,” “associated with” or “has a connection to,” or “builds upon the fruits of” embryo destruction. It only prohibits funding of research “in which” embryos are destroyed. It is important to remember that Dickey-Wicker is an appropriations rule, so the reasonable interpretation of the scope of the “research” in question is to follow the money in the grant request. If the grant application seeks money for an acitivity that directly results in embryo destruction, this proposal constitutes research “in which” the embryo is destroyed. If an applicant seeks money to study an existing hESC line, the research in question is not research “in which” the embryo is destroyed.