On again, off again, on again…Part 2

This two-part series, a response to the recent appeals court decision lifting an injunction on federal funding of human embryonic stem cell research, was co-authored by M. William Lensch, George Q. Daley, and Leonard Zon of the Stem Cell Research Program at Children’s Hospital Boston. (Read Part 1.)

While there is reason for optimism, the April 29 appeals court ruling lifting the injunction on federal funding for human embryonic stem cell (hESC) research will not be the last chapter in the story of such research in the United States. And there are moments in this story that hold cause for greater alarm.

The reinstatement of the Sherley-Deisher case (after its initial dismissal in 2009 for lack of standing) and the subsequent injunction sent shockwaves through academic laboratories nationwide, not only those conducting hESC research using federal funds (all of which were forced to stop immediately) but arguably every lab with NIH funding. This was due to a clause in the reinstatement ruling that as allowing funding for hESC research “…intensified the competition for a share in a fixed amount of money, the plaintiffs will have to invest more time and resources to craft a successful grant application. That is an actual, here-and-now injury.”

This reasoning, which paved the way for the injunction, would seem to apply to any new area of investigation seeking federal grant support. This view leads scientists to question the framework within which innovative science might be funded (or not) should this case ultimately prevail, and highlights just one way in which the overall suit could have implications far beyond hESC research.

The case is far from over and the future of hESC research funding remains unclear. The April 29 ruling pertains only to the injunction itself, not the underlying suit by Sherley and Deisher. In fact, to date no court has yet ruled on the full merits of the case. Though there are indications for its future: An important aspect of April 29 ruling states that Sherley and Deisher are “unlikely to prevail.” Regardless of the outcome once the case returns to District Court, it seems likely that the losing side will appeal.

In a New York Times article published the day the injunction was vacated, Congresswoman Diana DeGette of Colorado indicated she was “extremely pleased with this decision.” The article stated that Representative DeGette “promised to push for unambiguous legislation that would allow such research to continue.” This is an important statement considering that Representative DeGette and her former colleague Representative Mike Castle of Delaware twice passed legislation supporting hESC research through both houses of Congress, only to see it vetoed by President Bush.

The Dickey-Wicker amendment should be stricken altogether, or amended to permit continued funding of scientifically and ethically justified research according to the standards articulated by the NIH. The former is widely seen to be politically unfeasible, but what about the latter? It seems to us that given the NIH has articulated a clear framework for the ethical review and approval of lines of hESC for funding eligibility – a process requiring documentation of institutional review, unambiguous consent from couples donating embryos to research, and that no financial inducements were provided among other, equally well-reasoned requirements – that the same funding distinction between the embryo and hESC that has functioned under three presidents should be capable of supporting hESC research going forward. The majority opinion in the April 29 decision supports this position, going so far as to state that, “…the NIH has explained how funding an ESC project is consistent with the Dickey-Wicker Amendment.”

Given that until now the major policy statements have been presidential orders, not legislation, this “on again, off again” situation could continue until the nature of the federal law impacting hESC research funding is changed. Thus, we join Representative DeGette in applauding the April 29 ruling, and urge her and her colleagues to draft and pass legislation that ensures that hESC research will continue to be judged on its scientific merits.