End of the road for hESC opponents

WASHINGTON, D.C.—Federal funding for scientific and medicalresearch involving the use of human embryonic stem cells (hESCs) will continueunimpeded after the U.S. Supreme Court on Jan. 7 declined to review thecontroversial case of Sherley v.Sebelius.

It's been a long road for the plaintiffs in the case—adultstem cell researchers James Sherley and Theresa Deisher—who filed their lawsuitin 2009. Although their case reignited a national debate over hESC research—andeven, at one point, temporarily brought federal funding for such researchefforts to a halt—their legal effort has been grounded by the high court'sdecision.

"We were of course disappointed that the court declined tohear 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-lifelaw firm representing the plaintiffs—tells ddn."The court grants a hearing in about one of every 4,000 cases. But we are stilldisappointed that the court didn't take this opportunity to solve two bigproblems that we have across the country, which are that courts are issuingpreliminary injunctions, but then changing their minds; and that the presidentis using executive orders to trump federal statutes."

Casey's clients filed their lawsuit shortly after PresidentBarack Obama, as one of the first acts of his first term, issued an executiveorder that lifted restrictions placed on federal funding of hESC research byhis predecessor, President George W. Bush. The order was quickly followed bynew U.S. National Institutes of Health (NIH) guidelines for hESC research and apublic comment period.

Sherley and Deisher sued the government, alleging thegovernment failed to review and respond appropriately to public comments on theguidelines, challenging the NIH's interpretation of the Dickey-Wickeramendment—a rider attached to a 1995 appropriations bill that prohibited the NIHand the U.S. Department of Health and Human Services from using appropriatedfunds for the creation of human embryos for research purposes, or for researchin which human embryos are destroyed—and finally, arguing that Obama's order intensifiedcompetition for limited government dollars, making it more difficult for themto 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 thegovernment's motion to dismiss the suit on the ground that the plaintiffslacked standing. However, in June 2010, the D.C. circuit court reversed thisdecision, finding that the plaintiffs had alleged sufficient competitiveinjury, and granted a preliminary injunction against federal hESC funding. TheNIH appealed this injunction, and just a few weeks later, the Court of Appealsissued a stay while the appeal was pending. Although the appeals courtrecognized that Dickey-Wicker was "ambiguous," it ultimately deferred to theNIH's interpretation that it could fund research using stem cells from embryosthat were not actually destroyed in the course of that research.

The plaintiffs then filed a petition for writ of certiorari with the SupremeCourt, arguing that the government failed to respond in any way to the 30,000comments 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 foraccepting a case for review include the need to resolve disagreements amonglower courts about specific legal questions, or to consider issues that seem tobe of importance to the public. That wasn't the case here, says Hank Greely, aStanford University Law School professor who has closely followed the case onhis 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 amnot sure the court feels like it needs to go out of its way to look for anotherone."

Antoinette Konski, a partner with Foley & Lardner LLP,where her practice focuses on intellectual property, agrees that the SupremeCourt may "have so much on its plate already, with what is happening with gunlegislation, the implementation of the new healthcare law, the budget and othermatters, and I don't see that the court has the appetite for this issue." Butshe does express a bit of surprise that the court didn't want to consider thecase, "in light of its decision to take the Myriadcase."

That case, Association for Molecular Pathology v. Myriad Genetics, concerns Myriad's patentson two genes associated with an increased risk for breast cancer. The SupremeCourt agreed to hear the case in November.

"The two cases can be seen as related as far as the legalquestions presented," says Konski. "The question presented to the court in the Myriad case is, 'are human genespatentable?' I think a similar question might be, 'are stem cell therapiespatentable if they are derived from the human body?' There could be someunintended consequences of the Myriadcase if the Supreme Court is not judicious with its language."

With this case put to bed, the plaintiffs say they are notconsidering any other legal action at this time.

"This has been a very long, hard journey," admits Sherley, ascientist at the Boston Biomedical Research Institute. "Being a scientist andnot an attorney or judge, the legal process is quite frustrating, because inour case, our complaint was very real. The issue was whether or not any of ushad standing in court, that we were effectively injured by an act of ourpresident to extort the NIH to fund hESC research.

"Forget about Dickey-Wicker for a moment," Sherleycontinues. "This is about ethics. As an NIH investigator, I have been involvedin human experimental research before, and I know the NIH already has policieson what it should and should not fund. The problem is that the NIH is notacknowledging that embryos are living human beings. If they recognize them ashumans, this research can't be funded by the NIH's preexisting policies."

According to Sherley's co-plaintiff, Deisher—who is thefounder, managing member and research and development director of AVMBiotechnology in Seattle—"one of the barriers here is that adult stem cells havebeen deliberately and very effectively kept out of the public eye. If thepublic is unaware of the alternatives to hESC research, and if someone has aloved one suffering from a debilitating disease and they are told that hESCresearch may hold the potential for a cure, it is very easy not to addressethical or moral issues. This debate really belongs in the public forum, and ifthe public is made more aware of the alternatives to hESC research, we canstart having some of these conversations."

Ultimately, Sherley says he believes adult stem cells willemerge as the cell line of choice for medical researchers, as maintaining andgrowing hESC lines remains problematic, and safety and efficacy issues arestill unresolved.

"I've seen reports about folks who are promoters of hESCresearch celebrating when they heard the news. One thing those people can bevery sure of is that hESCs or their derivatives are not going to be put intopeople's bodies with any success," he asserts.One such celebrator is Dr. Curt Civin, director of theCenter for Stem Cell Biology & Regenerative Medicine and a research dean atthe University of Maryland School of Medicine, who called the Supreme Court'sdecision not to review the case "a great relief to stem cell scientists."

"This threat to the progress of research towardtranslational 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 theopinions of most Americans). Hopefully, this controversy is over."