For at least the last decade, uncertainty and controversyhas swirled around human embryonic stem cell (hESC) research—how it isperformed and funded, specifically—in the United States. The American publicmay have been first made aware of hESC research concerns in the mid-1990s, whenPresident Bill Clinton signed into law a measure that prohibited the U.S.Department of Health and Human Services and the National Institutes of Health(NIH) from using appropriated funds for the creation of human embryos forresearch purposes, or for research in which human embryos are destroyed. Calledthe Dickey-Wicker Amendment, the legislation was actually a rider attached to anunrelated appropriations bill passed by Congress.
During the next administration, President George W. Bush passedan executive order that restricted federal funding of research in which celllines were "derived without creating a human embryo for research purposes ordestroying, discarding or subjecting to harm a human embryo or fetus." Manyresearchers will tell you that these actions, which cut off much-neededgovernment grants, effectively shut off work in this area.
It took a third presidency to change that, as in March 2009,President Barack Obama—as one of his first acts as the nation's newly electedleader—issued an executive order intended to reverse Bush's policy. The orderwas quickly followed by new NIH guidelines for hESC research and its December2009 approval of 13 human stem cell lines for research.
It didn't take long, however, for this order to bechallenged in several court cases—the most-watched of them taking Dickey-Wickerto task. Sherley, et. al., v. Sebelius,et al., a case filed in the U.S. District Court for the District ofColumbia, argued that Obama's order violates Dickey-Wicker. Last August,federal district judge Royce Lamberth, finding enough merit in the plaintiffs'arguments, issued a preliminary injunction that brought federal funding forembryo-destructive research to a halt.
About a month later, the U.S. Court ofAppeals temporarily suspended the injunction while the case was still pending.
In May, the court completely reversed Lamberth's ruling,saying it would impose a substantial hardship on stem cell researchers who havemulti-year projects already underway. The court's 2-1 decision also found thatthe funding of hESC research is permissible under Dickey-Wicker, as Congresshas renewed the amendment every year with the knowledge that it funds suchresearch.
And as we went to press with this issue, the court poundedits final nails into the case's coffin when it dismissed the lawsuitaltogether.
"This court, following the D.C. Circuit's reasoning andconclusions, must find that defendants reasonably interpreted the Dickey-WickerAmendment to permit funding for human embryonic stem cell research because suchresearch is not 'research in which a human embryo or embryos are destroyed,"Lamberth wrote in his ruling.
The jury is still out, of course, on whether the plaintiffswill appeal this ruling.
But while grant applications are once again flowing, it'sclear that concerns about hESC research are not pacified. In fact, hESCs havebecome so controversial, the field of stem cell research as a whole is shroudedin uncertainty—at least according to the court of public opinion and some roguelawmakers who are under the impression that something more insidious is afoot,like "the creation of animal-human hybrids," as one Ohio legislator hassuggested.
The question of whether the government should fund hESCresearch is also being asked at the state level, as many states have enactedlaws that encourage it, restrict it or even ban it altogether. Many of thosebattles are still being waged, commonly in the name of Dickey-Wicker.
With allof this uncertainty, I can't help but wonder: Isn't it about time Congressrevisited what is essentially an afterthought on a 15-year-old appropriationsbill, clearly articulated the facts and concerns about hESC research and putforth a specific policy on the matter?
Meanwhile, in our ongoing summer series on stem cellresearch, we've got an interesting discussion with three scientists currentlyworking in the field—one of whom was one of the named plaintiffs in the Sherley case. We hope you will enjoyreading their views on the subject in our editorial roundtable, which you cansee here.
We'll wrap up our series next month with a look at the stem cellindustry's major players, so until then, have a Dickey-Wicker of a summer.