Defendants failed in their argument that ESC research is distinct from embryo destruction.

A federal district judge has put a temporary block on federal funding for human embryonic stem cell (ESC) research, which was okayed by the Obama administration last year. The judge agreed with plaintiffs in a lawsuit contending that such research is illegal because it destroys embryos.

In August 2009, a number of Christian groups filed a lawsuit against the HHS and the NIH, charging that the Obama administration’s ESC policy violated the Dickey-Wicker Amendment. The law, passed annually by Congress, bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” The suit was dismissed because the court felt that the plaintiffs had no real chance of winning.

The case was appealed by James Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology. To justify their standing as plaintiffs, they argued that Congress’ policy to support ESC research caused increased competition for adult stem cell researchers.

In June the Court of Appeals reversed the previous decision, holding that plaintiffs Drs. Sherley and Deisher have standing under the competitor standing doctrine. The matter was remanded to the Federal District Court for the District of Columbia for consideration of the plaintiffs’ motion for a preliminary injunction. Yesterday chief judge Royce C. Lamberth went on to issue a temporary halt on federal funding of ESC research.

Since 1999, defendants determined that the Dickey-Wicker Amendment was not applicable to ESC research because ESCs are not embryos. They also made the distinction that derivation of ESCs from embryos results in destruction of embryos but research on ESCs did not. This argument was once again leveraged by the NIH and HHS. They also argued that the term “research” in the Dickey-Wicker Amendment is ambiguous.

Judge Lamberth, however, found that the distinction between ESC research and embryo destruction could not be made. “ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo,” judge Lamberth noted.

He also ruled that there was nothing ambiguous about the word “research” in the Dickey-Wicker Amendment. “Contrary to defendants’ argument, the term ‘research’ as used in the Dickey-Wicker Amendment has only one meaning, i.e., a systematic investigation including research, development, testing, and evaluation designed to develop or contribute to generalizable knowledge.”

After an initial review of judge Lamberth’s decision, Lisa A. Haile, co-chair of the global life sciences practice at international law firm DLA Piper, wonders whether the Dickey-Wicker Amendment should be overturned or clarified given that much ESC research uses excess embryos from in vitro fertilization clinics that would likely get destroyed anyway.

Previous articleFDA Sanctions Alexion’s RI Production Plant for Commercial Supply of Soliris
Next articleRoche to Pay Aileron $25M to Tap Into Stapled Peptide Expertise