August 24, 2010 FEDERAL DISTRICT COURT ENJOINS THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) AND ITS NATIONAL INSTITUTE

Advocates International (AI), part of the public interest legal team along with the Alliance Defense Fund (ADF) and Gibson, Dunn & Crutcher (GD&C) who brought the case before the court more than a year ago, is pleased with the decision of the United States District Court of the District of Columbia yesterday enjoining HHS and NIH from unlawfully expending taxpayer funds on research involving the destruction of living human embryos. The district court’s opinion followed the decision by the United States Court of Appeals earlier this summer finding that doctors doing adult stem cell research have ‘competitive standing’ to sue. Therefore, the court reinstated the doctors’ federal lawsuit, filed last summer that seeks to preliminarily enjoin and ultimately overturn the controversial guidelines for public funding of embryonic stem cell research that the National Institutes of Health issued on July 7, 2009. The preliminary injunction issued yesterday for the time being brings to an end the unlawful use of taxpayer dollars to fund research that will result in the destruction of human embryos. Since 1994, in what has been popularly known as its Dickey-Wicker Amendment to each HHS Appropriations Bill, Congress has expressly banned NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.”

According to AI’s General Counsel, Samuel B. Casey, United States District Court Judge Lambreth’s ruling, quoted below, “could not be clearer”:

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. Despite defendants' attempt to separate the derivation of ESCs from research on the ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an integral step in conducting ESC research. Indeed, it is just one of many steps in the "systematic investigation" of stem cell research. 45 C.F.R. § 46.102(d). Simply because ESC research involves multiple steps does not mean that each step is a separate "piece of research" that may be federally funded, provided the step does not result in the destruction of an embryo. If one step or "piece of research" of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment. Because ESC research requires the derivation of ESCs, ESC research is research in which an embryo is destroyed. Accordingly, the Court concludes that, by allowing federal funding of ESC research, the Guidelines are in violation of the Dickey-Wicker Amendment.

According to GD&C’s Thomas G. Hungar, lead trial counsel for the plaintiffs who argued the case before the Court of Appeals and before Judge Lambreth: "We are gratified that the Court agreed with our plain-language reading of the Dickey-Wicker statute. Congress has forbidden federal funding of research that entails the destruction of human embryos, and NIH needs to start complying with the law."

The plaintiffs contend that the NIH guidelines violate the congressional ban because they “necessarily condition funding on the destruction of human embryos.” In addition, the plaintiffs also allege that the NIH guidelines were invalidly implemented, because the decision to fund human embryonic stem cell research was made without the proper procedures required by law and without properly considering the more effective and less ethically problematic forms of adult and induced pluripotent stem cell research.

President Obama, in his March 11, 2009 Executive Order announcing his Administration’s policy stated he was determined to fund ethically “responsible, scientifically worthy human stem cell research…to the extent permitted by law”. Sadly, said AI’s Casey, “these guidelines while claiming to ‘implement’ the President’s directions, failed his own test because they are not only unlawful, they are based upon an ethically irresponsible misunderstanding of available scientific evidence. One of the expert stem cell researcher plaintiffs, Dr. James L. Sherley, explained that “the great irony of the guidelines is that research involving stem cells safely derived from human adults and other sources presents the same if not greater potential for medical breakthroughs, without any of the troubling legal and ethical issues related to embryonic stem-cell research.” Clinical trials using adult stem cells have successfully reversed the effects of diseases such as lupus, multiple sclerosis, and rheumatoid arthritis. The plaintiffs argue that because NIH promulgated its guidelines with a preconceived determination to fund human embryonic stem cell research and without considering these scientifically and ethically superior alternatives, the guidelines are invalid regulations and should be struck down.

Dr. David Stevens, Executive Director of Christian Medical Association, an organization of more than 16,000 doctors who are also plaintiffs in the case, said “we are opposed to this proposed illegal and unethical federal funding of destructive embryonic research that would compel every American to cooperate with such unlawful human experimentation and the violation of our fundamental medical research ethic never to lethally experiment on one human being simply to benefit the interests of other human beings.”

Sam Casey, co-counsel for the plaintiffs and General Counsel of Advocates International’s Law of Life Project, a public interest legal project specializing in cutting-edge bio-ethical issues, added: “The majority of the almost 50,000 comments that the NIH received were opposed to funding this research, and by its own admission, NIH totally ignored these comments. The so-called spare human embryos being stored in IVF clinics around the United States are not ‘in excess of need,’ as the NIH in its guidelines callously assert. They are human beings in need of biological or adoptive parents.”

The lawsuit is brought by a broad coalition of plaintiffs, including Dr. James L. Sherley, a former member of the MIT faculty, currently working as a senior scientist at the Boston Biomedical Research Institute; Dr. Theresa Deisher, the founder, managing member, and research and development director of AVM Biotechnology; Nightlight Christian Adoptions, a non-profit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization; all individual human embryos whose lives are now at risk under NIH’s guidelines; parents seeking to adopt human embryos; and the Christian Medical Association, a non-profit association of doctors dedicated to improving ethical standards of health care in the United States and abroad. The Alliance Defense Fund, a legal alliance of Christian attorneys and like-minded organizations defending religious freedom and the sanctity of human life, is also serving as co-counsel on the case and providing financial support.

A copy of the Court of Appeals and District Court decisions, the Complaint in the lawsuit, the President’s Executive Order, and the challenged NIH Guidelines and the comments thereon can be obtained by clicking the hyperlinks in the first or fourth paragraphs above.