The Precarious Legal Situation of Embryonic Stem Cell Research Funding

Late last summer, United States District Court Judge Royce Lamberth halted National Institute of Health (NIH) funding flowing to human embryonic stem cell (hESC) research. Judge Lamberth issued his injunction on the grounds that a newly relaxed executive policy toward hESC research funding violated the Dickey-Wicker Amendment, an appropriations bill rider that prohibits federal funding for research in which human embryos are destroyed.

Under Obama, the NIH had opted to interpret the amendment’s restrictions narrowly. The logic was as follows: federal funds may not support the initial phase of research during which hESCs are derived through the destruction of an embryo, but can reasonably be used to fund research utilizing the cell lines that are propagated thereafter. Lamberth rejected the NIH’s interpretation. Stating that the Dickey-Wicker Amendment is unambiguous in its wording, Lamberth ruled that the funding ban must apply to the research as a whole, and not just to the phase of the research during which the embryo itself is destroyed.

Under Bush, a tenuous balance had existed in which the NIH funded a select list of previously derived stem cell lines. In his effort to expand funding, Obama drew the ire of religious groups and anti-hESC researchers, thus prompting the lawsuit that has now thrown the entire field into tumult.

While the courts continue to wrangle with the case, research has slowed. Unsure of the political and financial future of their work, hESC researchers have entered a holding pattern. A new study in the journal Cell: Stem Cellhas found that even researchers who work with non-embryonic stem cells have been negatively impacted by the injunction. This is surprising to those who expected an hESC funding ban to be a boon to stem cell researchers who do not work with hESCs. In fact, oddly, after rejection of many of the original plaintiffs involved with the lawsuit, only the current case involving two non-embryonic stem cell researchers was deemed worthy of moving forward, and was so-judged on the grounds that the two scientists would likely suffer if the federal purse became open to hESC researchers.

In a profile of Dr. Theresa Deisher, one of the plaintiffs, Nature magazine similarly pointed out that funding for non-embryonic stem cell research far outpaces that allotted for embryonic stem cell research. Funding for the former, furthermore, has continuously grown in recent years even as hESC research has increased in profile. Thus, while the research community struggles to move forward, the assumption that gave the legal challenge its original merit has now been shown faulty.

Regardless, the case goes on, and all at a time when a host of advances have begun to give hope of finally translating stem cell research into clinical practice. As The Economist reports, at the time when the court case was beginning, clinical trials were underway to determine the efficacy and safety of hESC therapies in individuals suffering from spinal cord damage and Stargardt’s macular dystrophy.

In a major scientific achievement, researchers have discovered a method for walking normal cells back down the biological pathways of specification, resulting in induced pluripotent stem cells (iPSC) with all the same potential for regeneration and broad differentiation as an embryonic stem cell. iPSCs hold great promise, and it would be quite the twist were they to be found capable of functionally replacing hESCs and thus rendering the current controversy moot.

The science, however, is far from settled. Nature guards its answers as researchers labor painstakingly. In order for the process of discovery to move as quickly as possible, the present and future stability of research must be ensured. Forming questions, determining investigative methods, gathering resources and conducting experiments requires time and foresight. Viable research cannot be started and stopped on a judicial whim.

The human embryo and the research stemming therefrom continue to stand as eminent bioethical issues of our day. For now, it’s asking too much to think that our society could come to consensus. We can only hope for a speedy resolution to this most recent judicial dispute so that the wheels of discovery may continue to turn. Moving forward, the U.S. must strive to achieve a stable stem cell policy so as to avoid future instances of limbo. When science’s cutting edge presents society with ethical dilemmas we must recognize that in failing to accommodate the delicate process we risk losing the most valuable of rewards.

Photo Credit: BWJones