President Obama signed an executive order (Executive Order 13505 - Removing Barriers to Responsible Scientific Research Involving Human Stem Cells) on March 9, 2009, to reverse former President Bush’s August 2001 order, which limits research to 21 stem cell lines (NIH Stem Cell Registry currently has 135 eligible lines) and a blanket ban federal funding for embryonic stem cell research. The new order, however, does not lift the ban on funding for research on developing new lines of stem cells. The executive order charges the National Institute of Health to formulate revised guidelines on federal funding for embryonic stem cell research within 120 days, which it subsequently issued on July 7, 2009.
Obama’s decision found unlikely support from Nancy Reagan, who released the following statement:
“I'm very grateful that President Obama has lifted the restrictions on federal funding for embryonic stem cell research. These new rules will now make it possible for scientists to move forward. I urge researchers to make use of the opportunities that are available to them, and to do all they can to fulfill the promise that stem cell research offers. Countless people, suffering from many different diseases, stand to benefit from the answers stem cell research can provide. We owe it to ourselves and to our children to do everything in our power to find cures for these diseases - and soon. As I've said before, time is short, and life is precious.”
However, the new NIH Guidelines was challenged by the Law of Life Project legal team (Dr. James L. Sherley, Dr. Theresa Deisher, Christian Medical Association, Alliance Defense Fund, Nightlight Christian Adoptions and Gibson, Dunn & Crutcher) and a complaint was subsequently filed in the Federal District Court for the District of Columbia stating that the guidelines violated the 1995 Dickey-Wicker Amendment which states,
(a) None of the funds made available in this Act may be used for--
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).
(b) For purposes of this section, the term `human embryo or embryos' includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
Federal District Chief Judge Royce C. Lamberth ruled in favor of the plaintiffs on August 23, 2010 and granted a preliminary injunction halting all federal funding for embryonic stem cell research while he deliberate on the matter. In his ruling, Judge Royce noted that,
“Despite defendants' attempt to separate the derivation of ESCs (embryonic stem cells) from research on the ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an integral step in conducting ESC research… 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.”
The decision effectively paints all federally sponsored research from 1996, amounting to approximately $546 million, as violating the Dicky-Wicker Amendment. However, a follow up suit by the plaintiffs in July 2010 that sought to permanently ban federal funding for embryonic stem cell therapy were thrown out by Chief Judge Lamberth. In September 2010, Chief Judge Lamberth refused a request by the government to lift the injunction for federal funding pending his ruling.
The Justice Department filed an emergency request with the Court of Appeals for the district to countermand Judge Lamberth’s decision, citing disruption to existing research, which began prior to the Chief Judge’s ruling. The request was granted on September 9, 2009.
The Court of Appeals ruled again in April 2011, this time in favor of the defendants. In a 2-1 decision, Judge Douglas Ginsburg and Judge Thomas Griffith wrote a stinging commentary on Judge Lamberth’s earlier decision to allow the preliminary injunction.
“We need not wade into this circuit split today because, as in Davis, as detailed below, in this case a preliminary injunction is not appropriate even under the less demanding sliding-scale analysis. We review the district court’s balancing of the four factors for abuse of discretion…
…The Amendment, reenacted annually as a rider to appropriations legislation, prohibits the expenditure of federal funds both for “the creation of a human embryo or embryos for research purposes” and for “research in which a human embryo or embryos are destroyed…
It is the latter ban that the plaintiffs' claim is violated by the 2009 Guidelines. Determining whether hESC research is “research in which a human embryo or embryos are destroyed” requires determining the meaning of “research.” The plaintiffs contend that all hESC research constitutes research in which human embryos are destroyed and that the Amendment accordingly prohibits federal funding thereof. The Government counters that the derivation of hESCs and the subsequent use of those cells, although both research, are not part of the same—and prohibited—research…
… the plain meaning of the Amendment is easily grasped. See id. (“If the [statute] has a plain and unambiguous meaning, our inquiry ends so long as the resulting statutory scheme is coherent and consistent.” (internal quotation marks omitted)). Accordingly, “that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-43.
Because the plaintiffs have not shown they are likely to succeed on the merits, we conclude they are not entitled to preliminary injunctive relief. We reach this conclusion under the sliding scale approach to the preliminary injunction factors; a fortiori we would reach the same conclusion if
likelihood of success on the merits is an independent requirement. Therefore, the preliminary injunction entered by the district court must be and is Vacated”
Chief Judge Lamberth also ruled in favor of the defendant shortly thereafter, citing the ruling of the Court of Appeals as the basis of his judgment. The matter remains far from settled, however, as the plaintiffs have indicated that they might bring the case to the Supreme Court.
“Today with the executive order I’m about to sign, we would bring the change that so many scientists, and researchers, doctors and innovators, patients and loved ones that hope for and fought for these past eight years. We will lift the ban on federal funding for promising embryonic stem cell research.
We also vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield. At this moment, the full promise of stem cell research remains unknown and it should not be overstate. But scientists believe these tiny cells may have the potential to help us understand and possibly cure some of our most devastating diseases and conditions. To regenerate a severed spinal cord and lift someone from a wheelchair. To spur insulin production and spare a child from a lifetime of needles. To treat Parkinson’s, cancer, heart disease and others that affect millions of Americans and the people who love them. But that potential would not reveal themselves on its own. Medical miracles do not happen simply by accident. They result from painstaking and costly research, from years of lonely trial and errors, much of which never bears fruit. And from a government willing to support that work. From live saving vaccines to pioneering cancer treatments to the sequencing of the human genome – that is the story of scientific progress in America.
When government fail to make these investments, opportunities are missed. Promising avenues goes unexplored. Some of our best scientists leave for other countries that will sponsor their work, and those countries may surge ahead of ours in the advances that transform our lives.
As a person of faith, I believe we are called to care for each other and work to ease human suffering. I believe we have been given the capacity and will to pursue this research and the humanity and conscience to do so responsibly. It’s a difficult and delicate balance and many thoughtful and decent people are conflicted about or strongly oppose this research. And I understand their concerns, and I believe we must respect their point of view. But after much discussion, debate and reflection, the proper course has become clear. The majority of Americans from across the political spectrum and from all background and beliefs have come to a consensus that we should pursue this research. That the potential it offers is great, and with proper guidelines and strict oversight, the perils can be avoided. That is a conclusion with which I agree. And that is why I am signing this executive order. And why I hope Congress will act on a bipartisan basis to provide further support for this research.”
March 9, 2011; President Obama announces the signing of Executive Order 13505 - Removing Barriers to Responsible Scientific Research Involving Human Stem Cells