March 1, 2009 (Vol. 29, No. 5)

Bernard Siegel

Dickey Amendment Is an Antiquated Obstacle that Impedes Valuable Research

When President Bush assumed office, the human embryonic stem cell revolution was primed to launch. The outgoing Clinton administration directed the NIH to prepare comprehensive rules to govern the nascent field of discovery, with funding to follow. Eight years later, we have no comprehensive federal guidelines. Each funding authority has its own set of rules and funding has been relatively minimal, especially when compared to the annual $28 billion NIH budget.

President Bush ordered a hold on the NIH guidelines and purportedly studied the situation. On August 9, 2001, in a surprise Crawford announcement, President Bush actually narrowed the Clinton plan, permitting federal funding only to those stem cell lines created on or before that arbitrary date (August 9, 2001) and time (9:00 PM). Rather than making the pronouncement of this important public health policy by formal order, it was delivered by television address and a media advisory.

Twisting logic like a pretzel, President Bush premised his views that in vitro blastocysts were “human life” and to continue funding on stem cell lines created after his August 9 pronouncement would somehow induce derivation of new lines, thereby making the federal government complicit in the destruction of embryos. In the case of the few existing lines available for funding, by Bushian logic, the terrible deed had already been done and limited funding could proceed on those lines only.

Before considering President Obama’s plans, it serves us well to examine the legislative foundation that produced such an unsatisfactory policy. The actual rate-limiting statute is the Dickey Amendment, a largely overlooked legislative funding roadblock that is a perennial appropriations rider to the NIH budget. It is what Harvard philosopher Louis Guenin aptly describes as the “elephant in the room.”

Named after its sponsor, former Arkansas Congressman Jay Dickey, the Dickey Amendment was enacted in 1995. It precludes using federal money for the creation, destruction, or endangerment of human embryos for research purposes. It is a blockade for funding research on embryos discarded from in vitro fertilization procedures to derive new cell lines or somatic cell nuclear transfer. It essentially codifies the viewpoint that embryo research is a moral transgression.

Each time the Dickey rider comes before Congress, it is enacted without debate. It was the law before the discovery of human embryonic stem cells in 1998 and is a throwback to the roiling abortion debate in America. In the Bush years, there was no appetite to directly challenge Dickey.

If the Dickey Amendment prohibits NIH funding endangering embryos, how can NIH fund any of this research? By literal reading of the Dickey Amendment, there is a loophole that would allow funding in narrow circumstances. Where the actual derivation of a stem cell line is accomplished without NIH monies, the resulting cell line could be eligible for federal funding. To date, every policy-maker seemingly worships at the Dickey altar and every funding scheme is designed to thread this narrow hole in the needle.

The absurdity of the rule is evidenced in the frustrations of research institutions to comply with current federal policy, or risk losing all of their NIH grants. Those institutions deriving new cell lines or undertaking research on “nonpresidential” lines are compelled to construct separate laboratories and manage complex bookkeeping systems to keep the NIH grant money separate. It’s a real mess.

President Obama will most certainly deliver the long-promised executive order lifting the Bush restrictions and Congress will subsequently deliver a bill making the new funding permanent. The likely statutory vehicle will be the bipartisan-supported Stem Cell Research Enhancement Act, also called the Castle-DeGette bill, a piece of legislation twice vetoed by President Bush, which would allow NIH funding on more recently derived stem cell lines.

However, that bill, as presently drawn, does not repeal Dickey, which seemingly remains sacrosanct. It will take courage and farsightedness by Congressional stem cell proponents to do away with this pernicious restriction on potentially lifesaving research.

Reframing the Policy

Lawmakers should seize this momentous time of change to completely reframe the underlying policy and enact laws to fully promote ethically sound embryonic stem cell research. As a point of engagement, they would be well served to read Louis Guenin’s seminal analysis of ethics and law, The Morality of Embryo Use, which suggests correct public policy should be underpinned by a couple’s decision to donate embryos for research, under the proviso that such embryos be barred from transfer to a womb. The very conditions of donation confer moral permissibility.

The unreasonable and arbitrary restrictions of the Bush administration resulted in an eight-year battle between social conservatives and the pro-cures movement, a broad coalition of patients, researchers, and industry.

If there is a silver lining to this contentious wedge issue in American politics, it is the increased public awareness about the potential of embryonic stem cell research and support for the entire field of regenerative medicine. Citizens became frustrated at the paucity of funding and angered by the extremist, draconian proposals directed against somatic cell nuclear transfer research, threatening researchers and even patients with lengthy imprisonment and massive fines. Stem cell research confers hope to understanding, treatment, and eventual cures of a host of medical conditions. Opposing research funding is akin to crushing hope.

At its core, the pro-cures movement is not an advocacy or political movement. It is a consumer movement, where citizens see embryonic stem cell research as a personal health issue. Consumer demand drives the entire field forward at every level. A key goal is to create a legal framework where scientific research targeting cures will thrive.

Eight years of unreasonable restrictions is enough. Imagine a new era where science policy is predicated on scientific merit rather than ideology. It is time for Congress to fully recognize the consequences of the Dickey Amendment and take immediate action. It is time for all stem cell advocates and their allies to call for the repeal of the Dickey Amendment.

Bernard Siegel, J.D. ([email protected]), is the founder and executive director of the Genetics Policy Institute, which presents the annual “World Stem Cell Summit.” Web: www.genpol.org.

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