By refusing to hear an appeal in the federal court case that once threatened to halt federal funding of human embryonic stem cell (hESC) research, the U.S. Supreme Court signaled its intent to move Washington past the four-year legal wrangle over the issue.
Without comment, the high court yesterday turned back a certiorari plea by the co-plaintiffs in Sherley v. Sebelius—James L. Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology.
“This marks the end of an era,” Bernard Siegel, executive director of the nonprofit Genetics Policy Institute, told GEN. “This has been a roiling battle that has gone on for more than 10 years. [The Supreme Court’s action] puts an end to it to the extent that we don’t see any further efforts at legislative restrictions. We have now stabilized funding for four years from NIH, which is great.”
Drs. Sherley and Deisher filed suit in 2009 against HHS, HHS Secretary Kathleen Sebelius, NIH, and NIH Director Francis S. Collins, M.D., Ph.D., seeking to overturn NIH’s 2009 Guidelines on Human Stem Cell Research. The guidelines were intended to codify President Barack Obama’s Executive Order that lifted restrictions on hESC research enacted by his predecessor, President George W. Bush.
The resulting federal case produced one major surprise alarming to the biopharma industry in 2010, when Chief Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a preliminary injunction temporarily blocking federal funding of hESC research. He reasoned at the time that the co-plaintiffs stood more than a chance of overturning the NIH guidelines. However, the preliminary injunction was overturned and remanded back to Judge Lamberth, who issued a 38-page decision siding with HHS, Sebelius, and Dr. Collins. It was that decision that the Supreme Court upheld.
In so doing, the justices brushed off the co-plaintiffs’ contention, expressed by Drs. Sherley and Deisher in a court filing, that “the federally sponsored hESC research that the guidelines support inevitably creates a substantial risk—indeed, a virtual certainty—that more human embryos will be destroyed in order to derive more hESCs for research purposes.”
That risk, they continued, violates the Dickey-Wicker Amendment of 1996, which says it is illegal to use federal funds for research “in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.”
“Congress designed a law to ensure that Americans don’t pay any more precious taxpayer dollars for needless research made irrelevant by adult stem cell and other research. That law is clear, and we had hoped the U.S. Supreme Court would uphold its clear intent,” Steven H. Aden, senior counsel for the Alliance Defending Freedom, which co-litigated the case for Drs. Sherley and Deisher. “Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law—especially in burdened fiscal times like these.”
Siegel said policy and funding disputes over hESC are still likely to emerge in some state legislatures.
“All these brush fires in different states—bills have been filed in almost every state almost every year, seeking restrictions on human embryonic stem cell funding in some way, shape or form, and these battles I think are still going to continue,” Siegel said. “The advocacy community will still have work to do.”