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Insight & Intelligence : Jul 27, 2011
Prospect of Court Appeals and Congressional Bill Hold the Cards for hESC Research
Case seeks to prevent the use of federal dollars, while Washington’s conservative bent is cause for concern.!--h2>
What a difference a year makes. The biotech community was jolted in August 2010 when Chief Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia temporarily blocked federal funding of research on human embryonic stem cells (hESCs) through a preliminary injunction.
He reasoned at the time that the co-plaintiffs in the Sherley et al. v. Sebelius et al. court case stood more than a chance of overturning 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.
Since then the preliminary injunction has been overturned and remanded back to Judge Lamberth. Both sides submitted supplemental briefs on June 24, and earlier today the judge issued a 38-page decision siding with co-defendants HHS, HHS Secretary Kathleen Sebelius, NIH, and NIH Director Francis S. Collins, M.D., Ph.D.
Also on June 24, a longtime supporter of hESC research reintroduced a bill directing Sebelius to maintain guidelines for conducting or supporting research on human stem cells including hESCs, review them every three years, and update them as scientifically warranted.
Rep. Diana DeGette (D-CO) has won support for her bill from a Republican co-sponsor, Rep. Charles W. Dent from Pennsylvania. While that is supposed to enhance the bill’s chances since GOP leadership now controls the House, no other co-sponsors from either major party have surfaced; the bill sits in the House Committee on Energy and Commerce.
“Scores of researchers across the country have the stability and continuity to conduct their critical research,” DeGette said in a statement applauding Judge Lamberth’s decision.
Even if other co-sponsors join Reps. DeGette and Dent, it’s hard to see their Stem Cell Research Advancement Act (HR 2376) going anywhere given the political division in Congress and the fact that the federal courts are now achieving the same objective. The next stop for opponents of hESC research is the same appeals court that upended Judge Lamberth’s preliminary injunction in April.
The bill, like the court case, pits proponents of hESC research who call it medically necessary against opponents who call it morally and ethically wrong given the destruction of embryos involved.
Garnering Support for DeGette Bill
Commenting on the potential of DeGette’s bill, Don C. Reed, vp for public policy for the Americans for Cures Foundation, told GEN, “It’s going to be harder with the increased conservative domination. I personally do not feel that the Tea Party people are any less conservative theologically. There are one or two maybe that are more libertarian, but I think most of them are pretty much the same as the typical ultraconservative Republican.”
Rep. DeGette, whose spokeswoman did not respond to queries from GEN, introduced hESC research bills that passed both chambers of Congress in 2006 and 2007, only to be vetoed by Bush. This year, given the Republican majority in the House, “this bill is such a waste of time,” Samuel B. Casey, managing director and general counsel for The Law of Life Project, told GEN. The Law of Life is a public interest legal organization “dedicated to legally defending the right to life and dignity of humans from biological conception until natural death.”
hESC research opponents including many within the House’s conservative majority are not swayed by language in Rep. DeGette’s bill directing that Sebelius “shall not use any funds for the conduct or support of human cloning.” That’s because the bill defines human cloning as “the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus.”
Casey noted, “We stop short of what people think of as human cloning, but at the same time we create an embryo that we then kill. What we don’t do is allow the clone to grow. DeGette’s bill is trying to have her cake and eat it too.”
Distinguishing between Derivation and Use
Casey is among lawyers representing 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. In their supplemental brief, Drs. Sherley and Deisher contended: “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.”
Drs. Sherley and Deisher remarked that “each time grant-awarding officials and federally funded scientists support or engage in hESC research, they ‘knowingly subject’ human embryos ‘to risk of injury or death,’ in violation of Dickey-Wicker.”
The co-defendants countered in their supplemental brief that NIH’s guidelines interpret Dickey-Wicker to allow the funding of hESC research but to forbid funding for their derivation. “Plaintiffs’ theory that the guidelines ‘incentivize’ the donation of future embryos casts no doubt on whether NIH had reasonably interpreted Dickey-Wicker, both because future donors would not be engaging in ‘research in which’ an embryo is subject to a risk of injury and because it is not plausible to claim that NIH funded researchers ‘knowingly’ create the incentive for future donation,” HHS and NIH contended.
The court of appeals that disagreed with and reversed Judge Lamberth’s injunction pointed out that it does not unambiguously bar funding for hESC research, “because Dickey-Wicker is written in the present tense, addressing research ‘in which’ embryos ‘are’ destroyed, not research ‘for which’ embryos ‘were destroyed.’”
By that reading, the appeals court continued, NIH must reject a grant application to support research that includes the derivation of stem cells. NIH would not be required, however, to consider the research for which the funds were sought to include “acts or processes such as deriving hESCs that predated the federally funded research.”
Drs. Sherley and Deisher also argued that the NIH guidelines violated both Dickey-Wicker and the Administrative Procedure Act (APA). The co-plaintiffs contended that NIH violated APA when it disregarded and deemed irrelevant roughly 30,000 comments challenging the ethical and scientific merits of hESC research, contending the basic issue of funding hESC research was outside the scope of the rulemaking.
But in his most recent decision, Judge Lamberth ruled that “NIH reasonably interpreted Executive Order 13,505, and operated consistently with both it and the APA’s requirements when it disregarded tens of thousands of public comments,” since the policy question of whether to provide federal funds for hESC research wasn’t at issue.
Judge Lamberth said he was bound by the appeals court decision that Dickey-Wicker could be interpreted to permit funding of hESC research but forbid funding for derivation. “While it may be true that by following the Court of Appeals’ conclusion as to the ambiguity of 'research,' this Court has become a grudging partner in a bout of 'linguistic jujitsu'…such is life for an antepenultimate court,” Judge Lamberth said in his decision.
But as could be expected, the loser in the District Court is expected to appeal to higher courts, all the way to the Supreme Court. Casey and other lawyers representing Drs. Sherley and Deisher said July 27 they were weighing the options for an appeal.
“Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law,” said Steven H. Aden, senior counsel with the Alliance Defense Fund (ADF).
Potential in the High Court
A Supreme Court decision worries supporters of unrestricted federal hESC research funding given the conservative leanings of several of the justices. If the worst happens, and they declare that NIH’s guidelines violate Dickey-Wicker, then those in favor of hESC studies will have to fight Dickey-Wicker or pass a law like DeGette bill, said Reed.
Neither option appears to offer a clear-cut path to success. For one thing, Congress has approved Dickey-Wicker each fiscal year from 1996 through 2010. Reed disputes the argument that Dickey-Wicker expresses the unambiguous intent of Congress, though. He pointed to the fact that it was originally attached to a continuing resolution for FY 1996 programs, then again to FY 1997 appropriations, rather than debated and passed as its own bill.
Even when they had control of the House, Democrats didn’t scrap Dickey-Wicker. “The Democrats have tried to change Dickey-Wicker, and all those times they have failed because Congress knew there was no important distinction between derivation versus use, and Congress simply didn’t want to spend taxpayer dollars to anything that came close to doing research on human subjects,” Casey said.
“If you’re an average citizen, and you’re an average politician, you know why. Because there is no way the average citizen could make a distinction between derivation and use. It’s politically a nonstarter.”
Reed also pointed to the 2006 and 2007 DeGette bills that were vetoed by then-President Bush. Republicans controlled both chambers of Congress in ’06; likewise Democrats in ’07. While control of Congress is now split, today’s Republicans are more conservative than those of 2006 or ’07, which doesn’t help the odds that Rep. DeGette’s bill will pass this year. Rep. DeGette’s bill didn’t pass last year’s lame-duck session, which was when Democrats still controlled the House.
Success Hinges on Washington and Court Case
While the court case is expected to continue into appeals and Rep. DeGette’s bill awaits action in Congress, NIH has been busy adding hESC lines that are eligible for agency funding. In June alone, 37 such lines were approved, raising the total number of government-allowed hESC lines to 128. So far this year, NIH has endorsed 42 hESC lines, compared with 46 in all of 2010 and 40 in 2009. That activity is expected to continue while litigation is winding its way through the courts.
Some other NIH numbers tell a no less important tale. During FY 2010, NIH funded $415 million in human adult stem cell research, compared with just $166 million on hESC studies. A year earlier in FY 2009, the agency funded $397 million in human adult and $143 million in human embryonic stem cell work.
Figures for both years were boosted by the availability of extra NIH funds through the $814 American Recovery and Reinvestment Act. This fiscal year, the numbers should dip to $341 million for human adult stem cell and $125 million for hESC studies.
Adult stem cell research doesn’t seem to have been slowed by controversies. Progress in this space resulted in, last year, adult cells being used by Italian researchers to restore sight in 69% of chemically blinded patients undergoing a transplant (77% with two transplants).
Work on embryonic stem cells may see its research dollars grow in time if there is more encouragement in Washington. “Human embryonic stem cells are thought to have much greater developmental potential than adult stem cells,” according to NIH. Over time the agency’s budget for hESC research will reflect that thinking if the Supreme Court decision favors the defendants. If not hESC scientists will have to pursue private funds more or shift their studies overseas altogether.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.
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