By Frederick Grinnell
On August 23, 2010, the United States District Court for the District of Columbia granted a preliminary injunction blocking NIH-funded research on human embryonic stem cells (hESC). According to Judge Lamberth’s ruling, NIH-funded research on hESC violates the Dickey-Wicker Amendment, originally passed by Congress in 1996, which prohibits use of federal funds for research in which human embryos are destroyed. The judge rejected the federal government’s claim that hESC research comes in separate pieces, i.e., human embryo destruction in the private domain on one hand vs. investigation of hESC by NIH-funded investigators on the other. Instead, he cited the holistic language of the Dickey-Wicker Amendment and the Random House Dictionary to conclude that the common definition of research includes development, testing and evaluation. According to Judge Lamberth’s ruling, destruction of human embryos and research on stem cells derived from human embryos are part of the same piece.
Destruction of human embryos occurs in the context of diverse research purposes. Some researchers aim to develop hESC-based therapeutic applications. However, others propose to improve the outcome of in vitro fertilization (IVF) procedures or to learn about early embryo development and disease progression. Currently, funding for research in which destruction of human embryos occurs is provided by non-Federal sources ranging from IVF clinics to biotechnology companies to state-sponsored biotechnology initiatives. Some of the research involving human embryo destruction has resulted in production of hESC lines. Some of the hESC lines that have been produced have been authorized to be used in NIH‑funded research, at least until the recent court order. Therefore, while one cannot deny that NIH-sponsored hESC research would be impossible without destruction of human embryos, destruction of human embryos is a research activity whose scope is much broader than and independent from the NIH‑funded work. From the point of view of research practice, the relationship between embryo destruction and hESC research is indirect.
In response to the judge’s preliminary injunction, the federal government has filed an appeal. The appeal challenges the judge’s understanding of the Dickey-Wicker Amendment regarding what constitutes the meaning of “research.” The appeal also challenges the judge’s conclusion that his decision would not seriously harm hESC researchers. On the contrary, if left in place, the injunction will have a potentially catastrophic effect because of its total disruption of NIH intramural and extramural hESC research.
One implication of Judge Lamberth’s ruling that has not been discussed but is of potential concern is whether the injunction against NIH-funding of hESC research might also apply to the FDA. The Dickey-Wicker Amendment concerns all of HHS not just the NIH. FDA is another major HHS agency that plays a role in hESC research. FDA develops guidelines and provides oversight for human clinical trials, including those involving hESC. As mentioned in the government’s appeal of the preliminary injunction, the FDA recently approved the enrollment of spinal cord injury patients in the first ever U.S. clinical trial of a hESC-based therapy. User fees from industry cover about half the costs of FDA drug review, but the remainder comes from federal funding. If embryo destruction and hESC research are part of the same piece of research, then are clinical trials also included, i.e., embryo destruction = hESC research = hESC clinical trials? If so, then should we conclude that federally‑funded regulation and oversight of hESC clinical trials causes human embryo destruction and thereby violates the Dickey-Wicker Amendment similar to NIH-sponsored research. An injunction preventing FDA from providing oversight for clinical research involving hESC would apply to all clinical trials regardless of sponsor. As a result, human hESC therapies could never be tested or implemented in the United States. Taken to its extreme, Judge Lamberth’s injunction not only disrupts NIH intramural and extramural hESC research, but also has to potential to end all hESC research in the U.S.
Frederick Grinell, Ph.D. is Professor of Cell Biology at the University of Texas Southwestern Medical Center. He is the author of Everyday Practice of Science: Where Intution and Passion Meet Objectivity and Logic, which is a finalist for the 2010 Royal Society Prize for Science Books.