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The NEW ENGLAND JOURNAL of MEDICINE

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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 Dick-ey–Wicker amendment, provides that no federal funds can be ex-pended by the National Insti-tutes of Health (NIH) for “(1) the creation of a human embryo or embryos for research purpos-es; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowing-ly 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 de-

ciding 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 po-litical and religious debates con-cerning 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 Hu-man 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 dis-solved the ethics board and ig-nored 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 recom-mended 7 as “acceptable for fed-eral funding” — but failed to produce a credible ethical justi-fication for its recommendations, which were widely ignored.2

Congress, however, responded to the report, and in 1996 Presi-dent Bill Clinton signed the first appropriations bill containing the Dickey–Wicker amendment, named for its sponsors, Repre-sentatives 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.

Resurrection of a Stem-Cell Funding Barrier — Dickey–Wicker in CourtGeorge 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 en-joining federal funding of stem-cell research —

The New England Journal of Medicine Downloaded from www.nejm.org on October 4, 2010. For personal use only. No other uses without permission.

From the NEJM Archive Copyright © 2010 Massachusetts Medical Society.

PERSPECTIVE

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The derivation of stem cells from embryos involves destroy-ing the embryo. In 2001, Presi-dent George W. Bush authorized federal funding for human em-bryonic stem-cell (ESC) research but limited it to cell lines that had been derived before his Au-gust 9 speech — and specifical-ly 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 po-litical f lashpoint, but he had promised to rescind the Bush policy, and there is wide support for expanded federal funding of ESC research. When Obama an-nounced his new policy author-izing funding for cell lines de-rived after August 2001 (if derived from surplus IVF embryos, with-out 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 re-search.”

Congress has not acted. In-stead, the debate has shifted to the courts, where the core ques-tion is whether the new Obama guidelines are consistent with Dickey–Wicker. Although he has not decided this question, Lam-berth 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,” be-cause “derivation of ESCs from an embryo is an integral step

in conducting ESC research.”1 Whether he will change his mind after briefing, argument, and per-haps testimony — or whether the Court of Appeals will rule other-wise — remains to be seen. The Obama administration’s new guidelines are based on the po-litical compromise of deriving ESCs only from surplus IVF em-bryos, and as part of this com-promise, the NIH seems to have conceded that derivation is an in-tegral part of stem-cell research, which is why it sets strict limits on the source of the embryos used and the quality of consent ob-tained. The political argument for permitting the use of surplus IVF embryos is that these embryos were created for a legitimate re-productive purpose, and when they’re no longer wanted for that purpose, their donation for re-search is ethically preferable to their destruction without any po-tential societal benefit.2 Of course, anyone who objects to the cre-ation of embryos for IVF would also object to this compromise. Does Dickey–Wicker permit this political compromise as a mat-ter 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 re-search. 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.”3 Their reasons were “the close connection in practi-cal 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 commis-

sion to examine the meaning of Dickey–Wicker concluded that the NIH’s distinction between deri-vation and use of human ESCs was a “reasonable” interpretation of the amendment — but that “there is no indication that ei-ther proponents or opponents [of ESC research] contemplated the situation . . . in which research that destroyed the embryo was separately conducted from re-search using the cells derived from the embryo.”4

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

Three paths are open to pro-ponents 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 interpre-

Stem-Cell funding and the Dickey–Wicker Amendment



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tation of Dickey–Wicker is cor-rect. But since victory is uncer-tain, the Obama administration should simultaneously aggressive-ly seek congressional authoriza-tion for its current regulations. The vehicle could be a bill pro-posed 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 proba-bly 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 pro-creation, including the deriva-tion of stem cells, when the cou-ple no longer wants to use them for procreation and has provid-

ed their informed authorization for them to be used in NIH-funded research.” Doing so would legislatively adopt the ethics po-sition of the Clinton bioethics commission. The third path is continued reliance on private and state funding until sufficient sci-entific 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 re-sponsibly, to learn how to trans-form 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.

Editor’s note: On September 28, the Court of Appeals decided not to reinstate Judge Lamberth’s injunction. The next step in the litigation is a hearing before Judge Lam-berth on the meaning of the Dickey–Wicker

amendment, and NIH funding will continue unless he or the Court of Appeals decides that such funding is prohibited by Dickey–Wicker.

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

From the Department of Health Law, Bio-ethics, and Human Rights, Boston Univer-sity School of Public Health, Boston.

This article (10.1056/NEJMp1010466) was published on September 15, 2010, and up-dated on September 30, 2010, at NEJM.org.

1. Sherley v. Sebelius, 2010 U.S. Dist. LEXIS 86441 (Aug. 23, 2010).2. Annas GJ, Caplan A, Elias S. The politics of human-embryo research — avoiding ethi-cal gridlock. N Engl J Med 1996;334:1329-32.3. Ethical issues in human stem cell re-search. Vol. 1. Report and recommendations of the National Bioethics Advisory Commis-sion. Rockville, MD: National Bioethics Advi-sory Commission, 1999.4. Flannery EJ, Javitt GH. Analysis of federal laws pertaining to funding of human pluripo-tent stem cell research. In: National Bioethics Advisory Commission. Ethical issues in hu-man stem cell research Vol. 2. Commissioned papers. Rockville, MD: National Bioethics Ad-visory Commission, 2000:D-1–D-13.5. Annas GJ, Elias S. Politics, moral and em-bryos: can bioethics in the United State rise above politics? Nature 2004;431:19-20.Copyright © 2010 Massachusetts Medical Society.

Stem-Cell funding and the Dickey–Wicker Amendment



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