Federal Court Halts Expansion of Embryonic Stem Cell Research

The New York Times reported that United States District Court Chief Judge Royce C. Lamberth issued a preliminary injunction blocking the federal funding of human embryonic stem cell research. This ruling severely impairs the progress of human embryonic stem cell research in the United States.

 

STEM CELL RESEARCH - GENERALLY

 

Presently, there are three types of stem cells used for research purposes: (1) human embryonic stem cells (“ESCs”); (2) adult stem cells (“ASCs”); and (3) induced pluripotent stem cells (“IPSCs”). Each type has unique research capabilities.

 

ESCs are pluripotent, meaning can to give rise to any of the approximately 200 types of cells in the human body, and can be used to treat diseases in two different ways - researchers can transplant ESCs into patients, or researchers may use ESCs to study disease mechanisms that cannot be studied within the human body, and to develop of the non-stem cell based therapies for these conditions. Recent studies using both methods of treatment suggest that ESCs will contribute to the development of medical knowledge in the future.

 

ASCs are found in tissues that are normally discarded after birth, such as the umbilical cord, and in the body. However, ASCs are limited because they are not pluripotent like ESCs. As such, ASCs cannot differentiate into the 200 types of cells within the human body.

 

IPSC research, the newest form of stem cell research, includes adult stem cells that have been genetically reprogrammed such that they are virtually identical to embryonic stem cells.

 

REGULATORY HISTORY REGARDING STEM CELL RESEARCH

 

The availability of federal funding for ESC research has been an issue for some time. In 1996, Congress enacted the Balanced Budget Downpayment Act, which contained a rider known as the Dickey-Wicker Amendment (“Amendment”). The Amendment prohibited the use of federal funds 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 acceptable federal regulations. This amendment is passed annually by Congress in every appropriations bill for Health and Human Services since 1996.

 

Some stem cell researchers reasoned that the Amendment did not apply to ESC research because ESCs are not embryos, and research on ESCs does not result in the destruction of an embryo. Specifically, a distinction was drawn between work that leads to the destruction of embryos — which could not be financed by the federal government— and work using stem cells created through embryonic destruction, which could be funded.

 

In 2001, President Bush issued an Executive Order prohibiting federal funding for research on ESCs that were created after August 9, 2001. On March 9, 2009, President Obama issued an Executive Order removing President Bush’s limitations on ESC research. As a result, President Obama directed the National Institutes of Health (“NIH”) to review its existing stem cell research guidelines and issue new NIH guidance on research that is consistent with his Executive Order.

Accordingly, the Guidelines for Human Stem Cell Research (“Guidelines”) were drafted by the NIH to allow funding for research using human embryonic stem cells that were derived from human embryos created using in vitro fertilization for reproductive purposes and were no longer needed for that purpose.

 

SHERLEY V. SEBELIUS

 

In the present case, Chief Judge Lamberth granted the preliminary injunction effectively blocking the federal funding of ESC research. In his opinion, Chief Judge Lamberth reasoned that the NIH Guidelines violate the language of the Amendment, because the Amendment prohibits research in which a human embryo is destroyed. In order to perform ESC research, ESCs must be derived from an embryo, and the process of deriving ESCs from an embryo results in the destruction of the embryo. Specifically, he reasoned that “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.”

 

Next, Chief Judge Lamberth reasoned that Plaintiffs would be irreparably injured if ESC researchers were allowed to seek federal funding for ESC research. Specifically, Plaintiffs, researchers that specialize in ASC research, asserted that obtaining NIH funding is necessary for their continued research, and the Guidelines, by allowing federal funding of ESC research, increases the competition for NIH funding. According to this opinion, competition for federal funding is enough of an injury to make a preliminary injunction a potential remedy.

 

Furthermore, Chief Judge Lamberth reasoned that it is in the public’s best interest to carry out the “will of Congress” and adhere to the Amendment. As such, federal funding of human embryonic stem cell research is presently enjoined.

 

This case is particularly interesting because although stem cell research can be a polarizing topic in our society due to the moral implications, it is the fight for funding between researchers that successfully brought this issue before a judge, and may ultimately decide whether human embryonic stem cell research may receive federal funding. It leads one to believe that no matter how moral the implications, money makes the world go around!

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