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Resurrection of a Stem-Cell Funding Barrier — Dickey–Wicker in Court

http://healthpolicyandreform.nejm.org/?p=12660&query=TOC

NEJM | September 15, 2010 | Topics: Health Law
George J. Annas, J.D., M.P.H.

Embryo research was born political. Expressions of shock and surprise at the August 23 ruling of federal district court judge Royce Lamberth enjoining federal funding of stem-cell research — which was based largely on his reading of an amendment to an appropriations bill — are thus not terribly persuasive.1 The amendment, known as the Dickey–Wicker amendment, provides that no federal funds can be expended by the National Institutes of Health (NIH) 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 risks of injury or death.” The case is now, for the second time, before the Court of Appeals for the D.C. Circuit, which has temporarily lifted Lamberth’s injunction and is deciding whether to reinstate it while the courts determine the amendment’s legal meaning.

The creation and destruction of human embryos for research are deeply tied not only to political and religious debates concerning abortion, but also to in vitro fertilization (IVF). In 1979, during the Carter administration, the Ethics Advisory Board of the Department of Health, Education, and Welfare (forerunner of the Department of Health and Human Services) recommended that the government support research on embryos in order to study and improve IVF. Federal research funding was never authorized, and IVF was introduced to clinical medicine without a research phase. The Reagan administration dissolved the ethics board and ignored its recommendations. The issue was next taken up during the Clinton administration by an NIH Human Embryo Research Panel, which voted on 27 goals of embryo research and recommended 7 as “acceptable for federal funding” — but failed to produce a credible ethical justification for its recommendations, which were widely ignored.

Congress, however, responded to the report, and in 1996 President Bill Clinton signed the first appropriations bill containing the Dickey–Wicker amendment, named for its sponsors, Representatives Jay Dickey (R-AR) and Roger Wicker (R-MS). It has been added to NIH appropriations bills every subsequent year, just as the Hyde Amendment restricting abortion funding is added.

The derivation of stem cells from embryos involves destroying the embryo. In 2001, President George W. Bush authorized federal funding for human embryonic stem-cell (ESC) research but limited it to cell lines that had been derived before his August 9 speech — and specifically to cell lines from surplus IVF embryos used with the consent of the couple whose egg and sperm were used to create them. No one challenged this policy as a violation of Dickey–Wicker, perhaps because, as Bush said, the “life and death decision” for these embryos had already been made.

President Barack Obama was well aware that federal funding of ESC research represents a political flashpoint, but he had promised to rescind the Bush policy, and there is wide support for expanded federal funding of ESC research. When Obama announced his new policy authorizing funding for cell lines derived after August 2001 (if derived from surplus IVF embryos, without the use of federal funds), he knew he could be reawakening the funding debate. He expressed his hope that “Congress will act on a bipartisan basis to provide further support for this research.”

Congress has not acted. Instead, the debate has shifted to the courts, where the core question is whether the new Obama guidelines are consistent with Dickey–Wicker. Although he has not decided this question, Lamberth has said he believes Dickey–Wicker is “unambiguous” and does not permit the NIH “to separate the derivation of ESCs from research on the ESCs,” because “derivation of ESCs from an embryo is an integral step in conducting ESC research.” Whether he will change his mind after briefing, argument, and perhaps testimony — or whether the Court of Appeals will rule otherwise — remains to be seen. The Obama administration’s new guidelines are based on the political compromise of deriving ESCs only from surplus IVF embryos, and as part of this compromise, the NIH seems to have conceded that derivation is an integral part of stem-cell research, which is why it sets strict limits on the source of the embryos used and the quality of consent obtained. The political argument for permitting the use of surplus IVF embryos is that these embryos were created for a legitimate reproductive purpose, and when they’re no longer wanted for that purpose, their donation for research is ethically preferable to their destruction without any potential societal benefit.2 Of course, anyone who objects to the creation of embryos for IVF would also object to this compromise. Does Dickey–Wicker permit this political compromise as a matter of law?

President Clinton’s National Bioethics Advisory Commission argued in 1999 that it was not ethically reasonable to separate the derivation of stem cells for research from their use in research. The commission believed that the federal government should fund both, for at least as long as the embryos used were those “remaining after infertility treatments.” Their reasons were “the close connection in practical and ethical terms between derivation and use of the cells” and the hope that permitting funding for cell derivation could advance science in this area.3 Lawyers asked by the commission to examine the meaning of Dickey–Wicker concluded that the NIH’s distinction between derivation and use of human ESCs was a “reasonable” interpretation of the amendment — but that “there is no indication that either proponents or opponents [of ESC research] contemplated the situation . . . in which research that destroyed the embryo was separately conducted from research using the cells derived from the embryo.”

The Clinton panel’s report got less attention than it deserved because at that time the national debate was focused on creating research embryos through cloning (somatic-cell nuclear transfer). Bush’s Council on Bioethics concentrated on cloning, but it was also the only national ethics panel ever to discuss federal funding as an ethical (rather than political) issue. It concluded that “the decision to fund an activity is . . . a declaration of official national support and endorsement, a positive assertion that the activity in question is deemed by the nation as a whole . . . to be good and worthy.” Such rhetoric seems disconnected from special-interest legislation5; a more honest statement regarding federal funding is that since Roe v. Wade, funding for anything remotely related to abortion (and since no one is pregnant, embryo research is only remotely related) has become a potent political liability in Congress. Obama’s own ethics panel has sensibly stayed out of this political funding debate.

Three paths are open to proponents of federal funding for human ESC research. The first is to mount a vigorous defense in the ongoing lawsuit, aiming to persuade the courts that the Obama administration’s interpretation of Dickey–Wicker is correct. But since victory is uncertain, the Obama administration should simultaneously aggressively seek congressional authorization for its current regulations. The vehicle could be a bill proposed by Representative Diana DeGette (D-CO), which authorizes research on stem cells derived from surplus IVF embryos; it has been passed twice (and vetoed by Bush) and would certainly be signed by Obama. Because this approach would retain Dickey–Wicker, however, and could thus lead to more legal challenges, it would be preferable (and probably more politically feasible) to amend Dickey–Wicker by adding language such as the following: “Nothing in part (2) prohibits the NIH from funding research using embryos created for procreation, including the derivation of stem cells, when the couple no longer wants to use them for procreation and has provided their informed authorization for them to be used in NIH-funded research.” Doing so would legislatively adopt the ethics position of the Clinton bioethics commission. The third path is continued reliance on private and state funding until sufficient scientific progress is made that the public demands federal funding for this research.

NIH Director Francis Collins has said that this issue “goes beyond politics . . . to patients and their families who are counting on us to do everything in our power, ethically and responsibly, to learn how to transform these cells into entirely new therapies.” This argument, of course, is itself political, and if Collins is right, the only place to resolve the funding issue is in Congress.

This article (10.1056/NEJMp1010466) was published on September 15, 2010, at NEJM.org.

Disclosure forms provided by the author are available with the full text of this article at NEJM.org.

Source Information
From the Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, Boston.

References

Sherley v. Sebelius, 2010 U.S. Dist. LEXIS 86441 (Aug. 23, 2010).
Annas GJ, Caplan A, Elias S. The politics of human-embryo research — avoiding ethical gridlock. N Engl J Med 1996;334:1329-1332
Full Text | Web of Science | Medline


Ethical issues in human stem cell research. Vol. 1. Report and recommendations of the National Bioethics Advisory Commission. Rockville, MD: National Bioethics Advisory Commission, 1999.
Flannery EJ, Javitt GH. Analysis of federal laws pertaining to funding of human pluripotent stem cell research. In: National Bioethics Advisory Commission. Ethical issues in human stem cell research Vol. 2. Commissioned papers. Rockville, MD: National Bioethics Advisory Commission, 2000:D-1–D-13.
Annas GJ, Elias S. Politics, moral and embryos: can bioethics in the United State rise above politics? Nature 2004;431:19-20
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