by Jake Meyer
Before the cells in your body become skin cells, muscle cells, or nerve cells, they are first stem cells. Human embryonic stem cells are pluripotent – they can become any of the approximately 200 types of cells in the human body – which makes them particularly valuable for treatment and research. Human embryonic stem cells could conceivably be used to treat patients, by transplanting them into damaged or diseased tissue. They can be used to study disease mechanisms that cannot be studied within the body and to develop non-stem cell based therapies for conditions. Among the many promising developments in stem cell research, researchers have created: dopamine-producing nerve cells that could be a promising treatment for Parkinson's disease, insulin-producing islet cells that control the insulin levels in mice with diabetes, and liver cells that could be used for treatment of liver diseases. But a recent case decision casts into doubt the legality of all federal funding of stem cell research.
Chief Judge Royce Lamberth of the District Court for the District of Columbia granted a preliminary injunction preventing the National Institutes of Health from implementing federal guidelines that allow for the federal funding of research on human embryonic stem cells. For researchers like Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, "[t]his ruling means an immediate disruption of dozens of labs doing this."
Judge Lamberth found that the NIH guidelines violate the Dickey-Wicker Amendment, a rider that has been attached to the annual appropriations bills for the Department of Health and Human Services since 1996. The Dickey-Wicker Amendment states that no federal funds shall be used for "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." Judge Lamberth found that stem cell research involves the destruction of embryos, with his analysis turning on the definition of "research."
The pivotal question was whether "research" as used in the Dickey-Wicker Amendment, in the context of stem cell research, would include both the derivation of human embryonic stem cells from an embryo and the subsequent research on the stem cells, or whether "research" would only pertain to the actual study and investigation of human embryonic stem cells. Human embryonic stem cells are derived from embryos. The process of deriving stem cells from embryos results in the destruction of the embryo, which is typically four or five days old. Once the stem cells are derived from an embryo, the stem cells can be maintained indefinitely.
The federally-funded researchers who undertook research once President Obama gave the go-ahead did not themselves destroy any embryos to create stem cell lines. Instead, they used stem cell lines that were created elsewhere, without federal funds. The NIH argued human embryonic stem cell research does not destroy embryos because the research is performed only on stem cells, the research does not involve embryos, and the research does not result in the destruction of embryos. The NIH argued that the derivation of stem cells from embryos is separate and distinct from stem cell research. Judge Lamberth didn’t agree with the NIH's argument. Lamberth considered the derivation of the stem cells from embryos and the research on stem cells to be considered "research," and not two separate types of research (or two steps: (1) derivation and (2) research). Lamberth reasoned that in order to conduct research stem cells must be derived from an embryo, and because the process of deriving stem cells results in the destruction of the embryo, human embryonic stem cell research "necessarily depends upon the destruction of a human embryo."
So what does this mean for stem cell research? Judge Lamberth maintains that the "injunction, however, would not seriously harm [human embryonic stem cell] researchers because the injunction would simply preserve the status quo and would not interfere with their ability to obtain private funding for their research." However, Lamberth’s decision does not maintain the status quo. This statement ignores the reality that many labs and researchers began stem cell research after President Obama's 2009 Executive Order, which opened up more stem cell lines for federally funded research as long as federal funds were not used for the derivation of the stem cells. Many of these labs will have to stop research unless they can secure private funding. Further, the reasoning of the decision also casts into question the legality of research on the 71 previously derived and existing stem cell lines that were approved for federally funded research under President Bush’s 2001 Executive Order. Although the stem cell lines approved by President Bush were derived many years ago, under Lamberth’s reasoning, these stem cells would also be considered research where the embryo is destroyed, because when the stem cells were originally derived, an embryo was destroyed. Therefore, according to this decision no research can be undertaken on stem cells with federal funds.
The executive orders of both Presidents Bush and Obama made the distinction between the federal funding of the derivation of human embryonic stem cells and the federal funding of research on human embryonic stem cells. Judge Lamberth's decision ends this distinction. So now researchers are forced to stop their research and we become once again one of the only countries in the developed world not pursuing human embryonic stem cell research – a promising area of research – with government funds because one district court judge read an extremely broad definition of "research" to vindicate moral objections to the destruction of an embryo. Under President Obama’s executive order, the embryos used to derive human embryonic stem cells were created for assisted reproduction, were no longer needed for assisted reproduction, and were donated with consent. In the case of existing human embryonic stem cells made available by President Bush, the embryos were destroyed many years ago. But under Lamberth's decision, none of these stem cell lines will be studied to find future cures and treatments with federal funds. The Department of Justice has announced that they will appeal the decision, and with any luck, this decision will be reversed and important stem cell research, with the support of federal funding, can quickly resume.