Stem cells still alive

Courts support legality of research

Human embryonic stem cell researchers — at MIT and elsewhere — can rest easy … at least for now.

After five months of waiting for two different courts, the U.S. legal system has taken one small step toward permitting that research to continue. But it will be months before the case is fully resolved. Friday morning, the United States Court of Appeals for the District of Columbia voted 2-1 to dismiss a preliminary injunction barring the National Institutes of Health from funding human embryonic stem cell research.

That injunction had been on hold (stayed) while the court heard an appeal in the case, Sherley v. Sebelius, so researchers have been able to continue their work during these past months. The case was argued before the three-judge panel on Dec. 6, 2010.

In the case, former MIT professor and adult stem cell researcher James L. Sherley sued the U.S. government to prevent the NIH from funding human embryonic stem cell research, on the grounds that it violates a Congressional appropriations rider barring federal funding of research that destroys human embryos.

Sherley, who is black, was denied tenure by MIT in 2006. This led to a hunger strike by Sherley and an acrimonious dispute over the tenure process; Sherley claimed his tenure decision was a result of racism. He is now a researcher at the Boston Biomedical Research Institution, which does not support Sherley in this case. Sherley, like all BBRI investigators, is expected to fund his own research, including his salary.

In a 21-page decision, Judge Douglas Ginsburg wrote:

“Two scientists brought this suit to enjoin the National Institutes of Health from funding research using human embryonic stem cells (ESCs) pursuant to the NIH’s 2009 Guidelines. The district court granted their motion for a preliminary injunction, concluding they were likely to succeed in showing the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that bars federal funding for research in which a human embryo is destroyed. We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used. We therefore vacate the preliminary injunction.”

Ginsburg was joined by Judge Thomas Griffith. Both judges had seemed to favor the government’s side at oral argument, so their votes did not come as a surprise. Much of the decision was spent on the definition of the word “research,” a subject that consumed scores of pages in the briefs submitted to the court.

One of the central questions of the case is whether current stem cell research that uses stem cell lines that were derived from embryos years ago qualifies as the same “research” as the original derivation. If it does, then the research is barred by Dickey-Wicker; if not, the research is legal.

The dissent by Judge Karen L. Henderson was “unusually strong,” said Samuel B. Casey, part of the legal team for Sherley and his co-plaintiff, Theresa A. Deisher. Sherley and Deisher are adult stem-cell researchers who maintain that their grant prospects are harmed by the NIH’s ability to fund human ESC research.

Henderson wrote that by “breaking the simple noun ‘research’ into ‘temporal bits’ [and] narrowing the verb phrase ‘are destroyed’ to an unintended scope … my colleagues perform linguistic jujitsu.”

She wrote that Sherley and Deisher are likely to succeed on the merits of their lower court case, and thus the lower court did not abuse its discretion in granting the preliminary injunction.

Casey said that the on the basis of Henderson’s dissenting opinion, Sherley and Deisher are seriously considering appealing the three-judge panel’s decision to an en banc panel of the entire circuit court. Such appeals are quite uncommon, and are usually lost, Casey said, but he feels they could prevail.

Casey said that overall, he was “sightly disappointed but not surprised” with the appeals court decision, noting that one cannot expect to hit a home run every time one is at bat.

On Friday, the White House said that “today’s ruling is a victory for our scientists and patients around the world who stand to benefit from the groundbreaking medical research they’re pursuing.” The Department of Justice said that they were pleased.

Francis S. Collins, director of the NIH, said in a statement that he was “delighted and relieved” by the decision. “This is a momentous day — not only for science, but for the hopes of thousands of patients and their families who are relying on NIH-funded scientists to pursue life-saving discoveries and therapies that could come from stem cell research.”

As has been true throughout this case, MIT did not comment on the decision.

Next steps

Now that the preliminary injunction has been dismissed, eyes are on the United States District Court for the District of Columbia, where the case is being argued on its merits. That court issued the preliminary injunction barring the research on Aug. 23, 2010.

Both sides have motions for summary judgement before Chief Judge Royce C. Lamberth of that court. Summary judgement is a request for the court to decide the case on the basis of agreed-upon facts that are already before it.

Casey said that the district court was likely to ask both sides to submit briefs outlining how the circuit court decision changes the case.

Because the majority of the appeals court panel concluded that the funding statute is ambiguous, Lamberth will have to consider that as he moves forward.

Of course, if Sherley and Deisher appeal the case to the circuit court en banc, then the lower court proceedings will likely pause again.

Case could reach Supreme Court

Either way, all involved are in this case for the long haul. Casey said that it was likely to reach the Supreme Court, noting that Sherley and Deisher would appeal there if they lost at the district and appellate levels, and that he thought the Department of Justice would do the same.