Last Friday, an appellate court upheld an earlier judgment allowing government to fund embryonic stem cell research for the development of new therapies. Biotechs and advocacy groups cheered the decision but uncertainty remains, in large part due to the possibility of a Romney administration in the White House.
In the American version of the Australian TV series Wilfred, the show’s title character declares that for him, human life begins at 10 years old. When his companion accuses him of being flagrantly immoral, Wilfred takes umbrage at the assertion and offers the following riposte: “If you kill an 11 year old, you’re going straight to hell.” For now, the question of precisely when a life begins, and what that means for scientific research, is determined more by culture and politics than hard science.
Australia and America have similar policies governing stem cell research, but many countries disagree on the details of when and how a human embryo can be destroyed in order to create a stem cell line for research, a process called derivation. Italy and Germany, for example, don’t allow derivation of hESC from excess in vitro fertilization embryos, a primary source in other countries, and a method Mitt Romney supports (or used to support). In South Dakota, hESC research is a crime, and residents of the state are forbidden from receiving any treatments based on embryonic stem cells approved by FDA.
South Dakota notwithstanding, the national mood in America has evolved on the issue of embryonic stem cell research. After the 2008 presidential election, President Obama didn’t waste much time eradicating former President George W. Bush’s executive order that halted NIH funding for any hESC research on stem cell lines not already in existence. Researchers were free to solicit private funds for their programs, but if a scientist wanted to conduct basic research on the government dime, it would have to be on a done on a very limited supply of stem cell lines derived prior to 9pm eastern time on August 9, 2001. In 2009, Obama repealed that executive order with one of his own, and asked NIH to issue guidelines on research, including the establishment of “appropriate safeguards.” The NIH then issued guidelines based on its interpretation of Dickey-Wicker, an amendment prohibiting the public funding of research involving “the creation of a human embryo for research purposes, or research in which a human embryo…is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero” under the Public Health Service Act.
In its guidelines, the NIH interpretation defines “research” narrowly, and allows for hESC research funding, so long as the hESC lines already exist, and thus don’t need to be created or destroyed as part of the specific research program being funded. These guidelines provoked a lawsuit which, after a series of appeals, remands, and a preliminary injunction (which was vacated), the United States Court of Appeals for the District of Columbia issued a summary judgment in favor of HHS and the NIH last Friday.
Will the decision, combined with the “world’s first approved stem cell drug” last May bring an influx of investor capital and industry partnership with academic institutions focused on hESC research? Not likely, according to Hank Greely, a professor of law and genetics and director of Stanford University’s Center for Law and the Biosciences. “I think what has largely kept private money out of this field is that it’s not, for the most part, mature enough for private money.” Given that there isn’t a lot of private activity in the stem cell area, public funding for basic research is critical, says Greely. “If stem cells are ever going to make a significant medical contribution…there has to be some source of funding for the kinds of basic research that are going on now,” he says. “The field needs to advance to a certain level before companies see the opportunities and are willing to invest their own money in the more development-oriented kinds of research.”
Despite the ruling, uncertainty around future research capabilities remains. Jennifer Geetter, partner at McDermott Will & Emery, says that if “Obama is reelected, it stands to reason that the next secretary of HHS would likely continue” the NIH interpretation of Dickey-Wicker, and fund hESC research within the framework of its guidance. “If Mitt Romney were elected, it’s harder to know,” says Geetter. “Would changing NIH’s definition of research as it relates to hESC funding be a priority in his first 100 days? I don’t know.” Greely, for his part, suggests that Romney “would be highly likely to reinstate the Bush era restrictions on federal funding, or be even more restrictive.”
For a collection of Romney statements on the record regarding stem cell research, click here.