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LAW AND BIOETHICS

U.S. Stem Cell Research Policies in Need of an Update

The United States Court of Appeals for the District of Columbia Circuit recently offered what might be the final word on the most significant court case for stem cell research to date, Sherley v. Sebelius.

Sherley began in 2009 in the wake of new, more relaxed human embryonic stem cell, or hESC, research guidelines, issued by the Obama Administration, which differed significantly from those issued under the Bush Administration. In Sherley, two adult stem cell, or ASC, research scientists sued the federal government to invalidate these new hESC guidelines alleging, among other things, that they would suffer irreparable harm because the guidelines increased competition for already limited federal research funds. At issue were differing interpretations of prohibitions in the Dickey-Wicker Amendment, a “rider” amendment attached to the Balanced Budget Down payment Act of 1996 with little debate or consensus.

The Dickey-Wicker Amendment, or Dickey-Wicker, bans federal funding for both the creation of human embryos for research purposes and research in which human embryos are knowingly destroyed. Some might remember that Sherley’s protracted march through the federal courts included a moratorium on federal funding for hESC research for over two weeks in 2010.

The DC Circuit’s ruling in August of this year, however, had little in fact to do with Dickey-Wicker itself. The three issues on appeal addressed distinctly legal questions, such as whether the DC Circuit was bound by the 2011 decision, in favor of the NIH, by a different panel of judges of the same court. Those who had hoped for a substantial policy discussion were likely disappointed. However, Judge Janice Rogers Brown’s concurrence in the case proffers an apt reflection on the state of stem cell research policy that crystallizes the fundamental problem with Dickey-Wicker:

“Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate.”

Although Judge Brown does not further flesh out this comment—in fact, it is the final sentence of her concurrence—her point is well taken. Rider amendments do not undergo the same congressional review process as regular pieces of legislation and, as the scant few lines that Dickey-Wicker takes up in the Balanced Budget Downpayment Act demonstrate, they are usually very brief. Hence, they are inherently poor indicators of congressional intent.

It seems to me more prudent, as Judge Brown intimates and others have directly argued, to regulate such a complex and divisive issue as hESC funding through the product of the systematic and deliberate congressional committee review process. Comprehensive stem cell legislation has been proposed multiple times in recent years, but has never garnered enough momentum.

Judge Brown also stresses that Dickey-Wicker is outdated. While the science has changed markedly since its enactment, the more critical issue with Dickey-Wicker turns on the state of the science at the time of its enactment. Curiously, Dickey-Wicker dates to 1995, approximately three years before the derivation of the first stable hESC line. This chronological note could not be more critical.

Dickey-Wicker regulates a body of issues that could not have been foreseen at the time it was drafted. In fact, at the time, the bioethics community was captivated by the successful cloning of the first mammal, a sheep named Dolly, at the University of Edinburgh, and the resultant concerns over the prospect of human cloning that followed in its wake, not with the manifold issues that we would now consider common in stem cell research.

Judge Brown’s comment, ultimately, does not go far enough. The ultimate flaw of Dickey-Wicker is not that it is poor legislation—though it is—but that it is poorly matched to the current state of the science. In 2007, researchers reported the new discoveries in the use of human induced pluripotent stem cells, or iPSCs, developed by genetically reprogramming ASCs—a relatively abundant and ethically uncomplicated type of stem cell—to behave like embryonic stem cells.

Some argue that, while iPSC science has not yet been perfected, it might one day make embryonic stem cells obsolete. Research with iPSCs avoids the thorny ethical issues regarding personhood that have plagued hESCs. Even former presidential candidate Mitt Romney has supported iPSC research, echoing the common belief that, because no human embryos need to be destroyed in iPSC research, it circumvents the moral discord over the status of the human embryo.

This argument may not be wrong, but it jumps to conclusions that have not yet been borne out by the evidence, and it moves too fast. It is true that iPSC research does not require the destruction of human embryonic cells. In this sense, it might be said to be morally preferable to hESC research. However, scientists also say that not enough is known about iPSCs yet to determine whether they could ever fully replace hESCs. Moreover, the research required to answer that question itself requires—you guessed it—hESCs.

Further, iPSC research is not without its own ethical worries. For instance, some have called for revision to consent requirements for donors of adult somatic cells that can be used to make iPSCs. As the argument goes, because donated ASCs will be reprogrammed into iPSCs which, in turn, can be used for research in ethically complicated areas like large-scale genome sequencing, donors should be made aware of how their cells will ultimately be used.

In short, future policies will need to address the change in perspective necessitated by iPSC research—where the thorny ethical issues reside not in the origins of cells, but in their downstream uses. Because Dickey-Wicker is limited to hESC research, it cannot possibly take into account any future policy issues related to iPSC research.

I can think of few areas of biotechnology today that are immune from significant moral discord. But at the same time, stem cell research has, and continues to hold, almost infinite promise for therapeutic application. Most recently, a study suggests that stem cells can help to repair damage resulting from a heart attack, regardless of whether the cells originate with the patient or a donor.

Importantly, we have the foresight now to anticipate many of the ethical worries surrounding iPSC research that stand to complicate future policy development. I will not comment here on the dense issue of just how tightly science policies should be intertwined with, as a philosopher would say, a particular conception of the good. But as Judge Brown’s concurring opinion in Sherley vs. Sibelius makes clear: our current stem cell research policies are in need of an update.

Nicholas J. Diamond, a lawyer by training, works in health policy in Washington, DC, and has published on a variety of issues in health law, bioethics, and public health. He is also a LL.M. candidate at the Georgetown University Law Center.

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