NEW BLOCKS FOR OLD CELL LINES: Although many human embryonic stem cell lines have been used in research for years without necessitating the destruction of additional embryos, a recent injunction stopped federal funding for future research. Those in the field are awaiting congressional and judicial decisions on the matter. Image: WIKIPEDIA COMMONS/NISSIM BENVENISTY
Human embryonic stem cells can live on indefinitely when carefully cultured under just the right conditions. The legal and legislative environments for these cell lines, however, has gotten a lot less hospitable in recent weeks.
After a federal judge placed an injunction on federal funding for all human embryonic stem cell (hESC) research in late August scientists and advocates faced rules that were far more stringent than those under the George W. Bush administration. A temporary lift of the injunction, issued September 9 by a federal appeals court, has done little to solidify the field's future.
The fate of many projects now hangs on language in a congressional budget amendment that was passed years before the first human embryonic stem cell was isolated.
The legislation in question, the 1996 Dickey–Wicker Amendment, prohibits federal funds from being used for any work that would harm or destroy a human embryo. Rather than being voted on annually, the amendment is attached to a slew of other National Institutes of Health (NIH) legislation and gets renewed as part of a batch.
Under Dickey–Wicker, President Bush allowed federal funding for research only on stem cell lines that had already been derived (but prevented the government from backing the further destruction of any embryos). And President Barack Obama pushed the amendment's limitations by asking the NIH in 2009 to allocate funds for still more lines of cells.
But in his interpretation of the amendment, Chief Judge Royce Lamberth of the U.S. District Court for the District of Columbia ruled on August 23 that embryonic stem cells belong in the same legal basket as embryos themselves because, he argued, creating a cell line requires destroying an embryo. In contrast the U.S. Department of Health and Human Services (HHS) has argued that, in part because the cell lines can be maintained indefinitely and do not require subsequent embryo destruction, those cell lines and embryos are distinct, thus allowing for federal funding.
Lamberth's ruling gives the amendment a different legal spin. "I'm sort of in the thick of this and this never ever occurred to me as a possibility," says Doug Melton, a professor at the Harvard Stem Cell Institute whose work uses human embryonic stem cells that fall under the injunction. Others called Lamberth's ruling "draconian" and "a serious setback."
The sticky Dickey–Wicker Amendment
Although the direction of federal policy had seemed to be clear under the Obama administration, the law underlying it has proved not to be.
Until last month, few officials saw much need to alter the amendment. A 1999 interpretation of Dickey-Wicker, written by then counsel for the HHS, Harriet Rabb, held that embryonic stem cells in themselves did not classify as embryos and thus were not subject to funding limitations under the legislation. "It seemed it was working," says Richard Hynes, a professor for cancer research at the Massachusetts Institute of Technology, of the accepted interpretation.
And over the years, Congress had tried to clarify the language from outside of the amendment, twice passing a bill, known as the Stem Cell Research Enhancement Act—introduced in 2005 and 2007 by Diana DeGette (D–Colo.) and Mike Castle (R–Del.). The bill would have allowed for federal backing of embryonic stem cell lines that were derived from unneeded embryos that would otherwise be discarded after fertility treatments. Congress passed the bill twice, but President Bush vetoed it both times.
As Congress returns from summer recess this week, Michael Werner, a partner at Washington D.C. law firm Holland & Knight and executive director for the Alliance for Regenerative Medicine says he expects to get a better sense of whether legislators will try to push through another clarifying bill. Given the surprise nature of the recent injunction, Hynes suggests that both a legislative and legal route will need to be taken in parallel to ensure federal funding in the future. DeGette's bill was reintroduced in Congress earlier this year, and has recently been pushed to the top of the lawmakers' agenda.