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End of the road for hESC opponents
WASHINGTON, D.C.—Federal funding for scientific and medical research involving the use of human embryonic stem cells (hESCs) will continue unimpeded after the U.S. Supreme Court on Jan. 7 declined to review the controversial case of Sherley v. Sebelius.
It's been a long road for the plaintiffs in the case—adult stem cell researchers James Sherley and Theresa Deisher—who filed their lawsuit in 2009. Although their case reignited a national debate over hESC research—and even, at one point, temporarily brought federal funding for such research efforts to a halt—their legal effort has been grounded by the high court's decision.
"We were of course disappointed that the court declined to hear the case, but of course, we were also not surprised," Samuel Casey, managing director and general counsel for the Law of Life Project —a pro-life law firm representing the plaintiffs—tells ddn. "The court grants a hearing in about one of every 4,000 cases. But we are still disappointed that the court didn't take this opportunity to solve two big problems that we have across the country, which are that courts are issuing preliminary injunctions, but then changing their minds; and that the president is using executive orders to trump federal statutes."
Casey's clients filed their lawsuit shortly after President Barack Obama, as one of the first acts of his first term, issued an executive order that lifted restrictions placed on federal funding of hESC research by his predecessor, President George W. Bush. The order was quickly followed by new U.S. National Institutes of Health (NIH) guidelines for hESC research and a public comment period.
Sherley and Deisher sued the government, alleging the government failed to review and respond appropriately to public comments on the guidelines, challenging the NIH's interpretation of the Dickey-Wicker amendment—a rider attached to a 1995 appropriations bill that prohibited the NIH and the U.S. Department of Health and Human Services from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed—and finally, arguing that Obama's order intensified competition for limited government dollars, making it more difficult for them to get funding for their own research, which uses only adult stem cells.
A long court volley ensued. In October 2009, Judge Royce C. Lamberth of the U.S.
District Court for the District of Columbia granted the government's motion to dismiss the suit on the ground that the plaintiffs lacked standing. However, in June 2010, the D.C. circuit court reversed this decision, finding that the plaintiffs had alleged sufficient competitive injury, and granted a preliminary injunction against federal hESC funding. The NIH appealed this injunction, and just a few weeks later, the Court of Appeals issued a stay while the appeal was pending. Although the appeals court recognized that Dickey-Wicker was "ambiguous," it ultimately deferred to the NIH's interpretation that it could fund research using stem cells from embryos that were not actually destroyed in the course of that research.
The plaintiffs then filed a petition for writ of certiorari with the Supreme Court, arguing that the government failed to respond in any way to the 30,000 comments made on the NIH's new guidelines.
The Supreme Court made no comment in denying the petition, which is not an unusual move for the court. Important considerations for accepting a case for review include the need to resolve disagreements among lower courts about specific legal questions, or to consider issues that seem to be of importance to the public. That wasn't the case here, says Hank Greely, a Stanford University Law School professor who has closely followed the case on his Center for Law and the Biosciences blog.
"Even is the Supreme Court thinks a lower court has it wrong, if there is not disagreement in the lower courts, they let it go," Greely says. "As for the second instance, although this is a politically charged issue, I am not sure the court feels like it needs to go out of its way to look for another one."
Antoinette Konski, a partner with Foley & Lardner LLP, where her practice focuses on intellectual property, agrees that the Supreme Court may "have so much on its plate already, with what is happening with gun legislation, the implementation of the new healthcare law, the budget and other matters, and I don't see that the court has the appetite for this issue." But she does express a bit of surprise that the court didn't want to consider the case, "in light of its decision to take the Myriad case."
That case, Association for Molecular Pathology v. Myriad Genetics, concerns Myriad's patents on two genes associated with an increased risk for breast cancer. The Supreme Court agreed to hear the case in November.
"The two cases can be seen as related as far as the legal questions presented," says Konski. "The question presented to the court in the Myriad case is, 'are human genes patentable?' I think a similar question might be, 'are stem cell therapies patentable if they are derived from the human body?' There could be some unintended consequences of the Myriad case if the Supreme Court is not judicious with its language."
With this case put to bed, the plaintiffs say they are not considering any other legal action at this time.
"This has been a very long, hard journey," admits Sherley, a scientist at the Boston Biomedical Research Institute. "Being a scientist and not an attorney or judge, the legal process is quite frustrating, because in our case, our complaint was very real. The issue was whether or not any of us had standing in court, that we were effectively injured by an act of our president to extort the NIH to fund hESC research.
"Forget about Dickey-Wicker for a moment," Sherley continues. "This is about ethics. As an NIH investigator, I have been involved in human experimental research before, and I know the NIH already has policies on what it should and should not fund. The problem is that the NIH is not acknowledging that embryos are living human beings. If they recognize them as humans, this research can't be funded by the NIH's preexisting policies."
According to Sherley's co-plaintiff, Deisher—who is the founder, managing member and research and development director of AVM Biotechnology in Seattle—"one of the barriers here is that adult stem cells have been deliberately and very effectively kept out of the public eye. If the public is unaware of the alternatives to hESC research, and if someone has a loved one suffering from a debilitating disease and they are told that hESC research may hold the potential for a cure, it is very easy not to address ethical or moral issues. This debate really belongs in the public forum, and if the public is made more aware of the alternatives to hESC research, we can start having some of these conversations."
Ultimately, Sherley says he believes adult stem cells will emerge as the cell line of choice for medical researchers, as maintaining and growing hESC lines remains problematic, and safety and efficacy issues are still unresolved.
"I've seen reports about folks who are promoters of hESC research celebrating when they heard the news. One thing those people can be very sure of is that hESCs or their derivatives are not going to be put into people's bodies with any success," he asserts.
One such celebrator is Dr. Curt Civin, director of the Center for Stem Cell Biology & Regenerative Medicine and a research dean at the University of Maryland School of Medicine, who called the Supreme Court's decision not to review the case "a great relief to stem cell scientists."
"This threat to the progress of research toward translational research discoveries, including regenerative medical therapies, is now removed," Civin says. "The Obama policies are affirmed by this decision, and the resulting NIH policies offer a reasonable way to proceed (in the opinions of most Americans). Hopefully, this controversy is over."