Embryonic stem cell research has been fraught with legal uncertainties since its inception. Embryonic stem cells are pluripotent cells obtained from embryonic tissue in a process that usually results in the destruction of the embryo. Once an embryonic stem cell line is established, however, it can be expanded and used by multiple labs for multiple research projects.
In response to ethical concerns about the destruction of human embryos, the Bush White house established restrictions on the use of embryonic stem cells. Research on a handful of cell lines created before August 9, 2001 was allowed, but federal funding for research on cell lines created after that date was prohibited. A few months after taking office in 2009, President Obama signed an Executive Order removing the restrictions, and asked the National Institutes of Health (NIH) to update their guidelines for the responsible use of embryonic stem cells (originally drafted in 2000).
Shortly after the restrictions were lifted, a lawsuit was brought against the NIH by Dr. James Sherley and Dr. Theresa Deisher, scientists opposed to embryonic stem cell research. The scientists asked that the court find the NIH guidelines invalid, citing a 1996 federal law called the Dickey-Wicker Amendment that prohibits funding for “research in which a human embryo or embryos are destroyed.” The NIH, in turn, took the position that an embryonic stem cell is not an embryo. The NIH states that the Guidelines “recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which Federal funding is prohibited, and research involving [human embryonic stem cells] that does not involve an embryo nor result in an embryo’s destruction, for which Federal funding is permitted” (Fed. Reg. 74 (128), 22107, 2009). The scientists bringing the suit also claimed that funding embryonic stem cell research hurt their ability to receive federal funding for their own research using adult stem cells. The court granted an injunction against funding for embryonic stem cell research in August 2010, which was lifted by a federal appeals court in April, 2011.
Yesterday, the U.S. District Court for the District of Columbia Chief Judge Royce Lamberth dismissed the suit. The judge issued a 38 page opinion (available, here, through Science Insider), in which he agreed with the appeals court’s finding that NIH can interpret Dickey-Wicker to allow funding for research on human embryonic stem cells but not on their derivation because the definition of “research” in the law is ambiguous. The judge also dismissed the plaintiff’s claims that NIH failed to respond to relevant and significant public comments. When NIH posted their updated guidelines for comment in 2009, many comments were returned that requested that no funding be allowed for embryonic stem cell research. NIH chose not to act on those comments, reasoning that their mandate, as provided in the Executive Order, was to provide guidance on the conduct of embryonic stem cell research, and eliminating such research was beyond their purview.The judge agreed with them on this matter.
Stem cell researchers, their supporters in and out of the science community, and patient advocacy groups are all letting out a sigh of relief. Stephanie Sutter, Assistant to the President and Deputy Senior Advisor, posted yesterday in her blog “For too long, patients and families have suffered from debilitating, incurable diseases and we know that stem cell research offers hope to millions of Americans across the country. President Obama is committed to supporting responsible stem cell research and today’s ruling was another step in the right direction.” But, be warned, the drama is not yet over. The plaintiffs are likely to appeal.