In late September, at the Southern California BioMedical Council's 10th Investor Conference, biotech firm Capricor Inc. announced that clinical studies were underway in another miracle of modern medicine. Using a process called Cardiosphere-Derived Stem Cell (CDC) therapy, doctors will be able to repair damage to patients' hearts by using cultures of their own heart cells. This latest in a long series of stem cell breakthroughs gives one pause to consider the legal state of stem cell research, both now, and in the years to come.
Stem cells are cells that have not yet completely “differentiated” into heart, lung, brain or other body parts' cells. Our bodies contain “somatic stem cells” that are only partially differentiated, and that can fully differentiate to repair minor organ damage—heart stem cells become heart cells, bone stem cells become bone cells, etc. In human embryos, however, there is another kind of stem cell: the Human Embyronic Stem Cell (hESC). This type is especially interesting because it has no predetermined role; an hESC can become any kind of cell in the body. It was the 1998 discovery of the technique to harvest hESCs from human embryos and then grow them in a lab that kicked off the modern stem cell research controversy.
In order to harvest and develop lines of hESC cells, individual human embryos, having the potential to become viable persons, must be destroyed. From this fact flows nearly all of the debate over stem cell research. The continued legal prohibition on the use of public funds in most hESC research over the last several years belies a history of legislative activity and shifting support on this issue. The 1995 Dickey Amendment (§ 128) was the government's first statement on embryonic research. It prohibited public funding of projects that sought to create or destroy embryos for research purposes. When President Clinton sought to allow funding for hESC research where the embryos were already destined for destruction (such as unwanted in vitro fertilization embryos), he had the Department of Health and Human Services consider regulations allowing research. By the time HHS proposed such regulations, recently-elected President Bush was considering an alternative approach. The Bush Administration limited publicly funded hESC research to 60 existing cell lines, barring funding of research on any newly-created ones. Congress tried to override the Bush Administration's funding limits twice, both under Republican and Democratic leadership, and faced vetoes each time.
Given the trend of Congressional support for hESC research, and the support of both John McCain and Barack Obama, the next presidential term may well bring a change in stem cell research policy. But there will undoubtedly be people unhappy with such a shift. In light of somatic stem cell advances such as the Capricor CDC therapy, as well as the state interest in protecting fetal life that was acknowledged in Roe v. Wade and its progeny, might some states prohibit hESC research under state law? In fact, some have already put such prohibitions in place, thereby restricting even privately-funded hESC research. Others have taken the opposite approach, going so far as to provide state dollars for stem cell projects. It will be interesting to see whether states that are more closely divided along the pro-life/pro-choice line and that have anti-stem cell research laws in place will relax or repeal those laws in response to a lifting of the hESC funding ban. Such a shift in state laws would not be unexpected if a significant proportion of the pro-life vote adopts the position of Sen. Orrin Hatch (R-UT) that there is no potential life interest lost in using unwanted in vitro fertilization embryos to develop stem cell lines.
And what about the question of whether hESC research is that important anyway, given the progress made on somatic stem cells? Considering the legal constraints on hESC research and the consequent funding disparity between those projects and human somatic stem cell projects, it’s hard to compare the prospects of the already-promising latter with the theoretically-revolutionary former. But that is a debate of science and technology, not law and policy.
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