Human Embryonic Stem Cell Research Put on Hold

On Aug. 23, a federal judge issued a preliminary injunction halting federal funding for research on human embryonic stem cells.  Ruling on a case brought by adult stem cell researchers and pro-life advocates, Judge Royce Lamberth of the District of Columbia District Court found that use of National Institutes of Health funds for any and all work on human embryonic stem cells – known as hES cells – is illegal.

In granting the injunction, Lamberth wrote that hES cell “research necessarily depends on the destruction of a human embryo,” violating federal law under the Dickey-Wicker Amendment. Federal funding for “research in which a human embryo or embryos are destroyed” is prohibited by the amendment.

As the defendant, the federal government has maintained that federal funding of hES cell research does not violate the Dickey-Wicker Amendment, since federal funds are still prevented from being used for the derivation of hES cells. However, the plaintiffs, James Sherley of the Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnologies, claimed that these funds were still being illegally appropriated for use on hES cells, and that, as adult stem cell researchers, they were at a competitive disadvantage when applying for NIH funds, as federal funding for hES cell research “increase[d] competition for NIH’s limited resources.”

While the District Court originally rejected the lawsuit, finding that the plaintiffs lacked standing and had not suffered from “irreparable injury,” the District of Columbia Court of Appeals disagreed, reversing the decision and sending the case back to the District Court for further review.

In reconsidering the case, Lamberth found in favor of the plaintiffs, agreeing that their injury was “of such imminence that there is a ‘clear and present’ need for equitable relief to prevent irreparable harm”, and that the injury was “beyond remediation.”

Since 1996, the Dickey-Wicker Amendment has been included in the annual appropriations bill that funds the National Institutes of Health.  However, no defined guidelines for funding hES cell research existed until 2001, when President Bush issued Executive Order 13435, which permitted the use of federal funds for research on established hES cell lines, but prohibited federal funds from being used to study any lines created subsequent to his announcement.

In March 2009, President Obama expanded on this law by issuing Executive Order 13505, allowing for federal funds to be used for research on additional lines which had been derived and propagated since 2001 using private funding.  Currently, there are 75 hES cell lines approved for use by the NIH Human Embryonic Stem Cell Registry, with over 150 lines awaiting review.

Stem cell researchers are unclear as to the reach of the opinion.  In his ruling, Lamberth insisted that issuing the injunction would “preserve the status quo”, suggesting to some that the Bush-era restrictions were now back in place.  However, most scientists interpret the language as a complete ban on all federally-funded hES cell research.

No date has been set for the trial.  Lawyers at the Department of Justice are currently reviewing the decision before deciding on how to proceed.

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