Legal Prognostication: Challenge to NIH Stem Cell Funding to End in 2013

A Stanford law professor is predicting that the legal fulminations about federal funding of human embryonic stem cell research will be resolved in 2013 in favor of the NIH.

That "best guess" comes from Hank Greely, who has been pondering stem cell legal issues for a number of years.

Writing on the Law and Biosciences Blog on the Stanford Law School web site, Greely issued the usual legal caveats and then said,

"But my best guess is that, sometime in 2013, the Supreme Court denies cert in this case and this question mark over human embryonic stem cell research funding is ended – though there may certainly be other questions raised between now and then.

"It is tempting to say 'all’s well that ends well.'  The judiciary seems to be headed to making a decision in this matter that is both (in my view) clearly legally correct and good policy.  But those who have suffered from the last 11 months of scrambling, uncertainty, and expense might have a different view.  It is one of the costs of our system of government – happily, in this case, so far, not a terribly high cost."

Minimal Media Attention to CIRM Reaction to Lawsuit Dismissal

The California stem cell agency drew little notice in mainstream media coverage this morning of yesterday's court decision dismissing a challenge to federal funding of hESC research.

That was pretty much to be expected given the lateness of the CIRM reaction to the news and was not an auspicious beginning for the "communications war" discussed last month by new CIRM Chairman Jonathan Thomas.

CIRM posted a news release with its reaction around midafternoon West Coast time. The first news stories about the decision appeared about six hours earlier.

The only mention we could find this morning of CIRM's official reaction was in a story by Eryn Brown of the Los Angeles Times. Her last paragraph read:

"'We clearly think it's the right decision,'" said Dr. Jonathan Thomas, chairman of the California Institute for Regenerative Medicine, the state's stem cell funding agency. 'It will now lift the cloud that's been hanging over researchers around the country.'"

The Associated Press story, most likely the most widely used and read article across the country, contained no mention of CIRM. It appeared on the San Francisco Chronicle, San Jose Mercury News and San Diego Union-Tribune web sites.

At The Sacramento Bee, which also carried the AP story, readers searching on the term "stem cell lawsuit" would have additionally seen a press release on PR Newswire from the Family Research Council, which is no friend of hESC research or CIRM. The public relations news service delivers press releases to many news sites around the country.

(Editor's note: An earlier version of this item carried a reference to an article in the San Diego Union Tribune. That article, however, was published prior to the decision referred to in this story. )

NIH Lawsuit Reaction: CIRM Chair Thomas Touts Research 'Stability' in California

The California stem cell agency this afternoon weighed in with a reaction to dismissal of the lawsuit against federal funding of hESC research, using the opportunity to promote the different situation in California.

It was the first foray by new CIRM Chairman Jonathan Thomas, outside of his election last month, in an official CIRM press release. Thomas said in the release,

"The field of stem cell research depends on a stable source of funding, such as CIRM provides in California. Young scientists uncertain about future funding might opt to work in areas other than stem cell science, which could slow progress toward new cures. This ruling is a positive step, but with the possibility that the case might be appealed, a predictable source of state and private funding continues to be essential."

CIRM President Alan Trounson was quoted as saying,

"California scientists have been able to carry on with research toward therapies for HIV/AIDS, diabetes, sickle cell disease and spinal cord injury, among others, without worrying about disruptions in their funding. With federal dollars available these scientists can leverage results from CIRM grants to get additional federal capital and can tap into potential collaborators in other states who bring expertise that could speed progress toward stem cell-based therapies."

Stability and potential leveraging are the two themes Trounson and Thomas hit – something that CIRM has tried to sell for some time.

The news release was a bit late for East Coast daily newspaper deadlines and much too late to be included in the initial news reports, but it could pick up some traffic on the Internet. Whether it makes any stories in California news outlets will have to be determined later.

When Thomas was elected, he said the agency is in a "communications war." However, CIRM is handicapped because it is in the midst of a reorganization of its PR efforts including the hiring of a director of communications to work out of Thomas' office.

NIH Wins Dismissal of Stem Cell Lawsuit

A lawsuit aimed at stifling federal funding for human embryonic stem cell research was dismissed today, but it was not immediately clear whether the decision would be appealed.

The dismissal by Judge Royce Lambreth received widespread attention from the mainstream meda and was heralded by researchers and stem cell advocates. One opponent, the Family Research Council noted, however, in a blog item by David Prentice that the debate on the legal question and issue is far from over.

From Washington, D.C., also came word that Reps. Diana DeGette, D-Col., and Charlie Dent, R-Pa., will continue to push their federal legislation to ensure that federal funding of hESC research would continue to be permitted.  Julian Pecquet wrote on thehill.com that DeGette said her legislation is "vital as ever."

Today's decision follows an earlier appellate decision in favor of the NIH. Meredith Waldman of Nature wrote,

"The appeals court in April said that, given the ambiguity of the word "research" in the text of the amendment, which prohibits government funding for "research in which a human embryo or embryos are destroyed", the NIH was "reasonable" in concluding that it could fund research using cell lines derived from embryos (which are destroyed in the process) as long as it does not fund the derivation itself.

"Today, Lamberth wrote: '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 a [lower] court.'"

Tom Schoenberg of Bloomberg News provided this background,

"In fiscal 2010, NIH spent about $200 million to fund more than 200 human-embryo research grants, the Justice Department and the institutes’ director, Francis Collins, said in court papers....The U.S. allowed 37 embryonic stem-cell lines for taxpayer- funded research in June, the most of any month this year, according to the NIH. The total number of U.S.-endorsed lines now stands at 128."

The California stem cell agency had no immediate reaction to the decision, but Amy Adams, CIRM communications manager, posted a short notice of the decision on the CIRM research blog with links to earlier items concerning the lawsuit.

National Stem Cell Doings: Rat Brains and Legal Wrangling

How is it going to go in the federal case involving hESC stem cell research?

A UC Davis scientist opines – that's one of those media words you see in print but rarely hear anyone utter – that the matter could go 2-1 for funding of research but possibly 2-1 against, given that two of the judges are appointees of young Bush.

You can read more from Paul Knoepfler here on his analysis of today's proceedings along with comments from his readers.

Also on the national stem cell front – sort of – is a column by the Maureen Dowd of the New York Times. On Sunday, she quoted Stanford's Irv Weissman on some monkey business in the US Senate race in Delaware.

He made his comments to Dowd in response to a 2007 statement by the Republican candidate in Delaware, who shall remain nameless. The candidate declared,

“American scientific companies are crossbreeding humans and animals and coming up with mice with fully functioning human brains.”

Weissman, who knows something about rodents, performed the first experiments injecting human brain-forming stem cells into the brains of immune-deficient mice 10 years ago.

Dowd wrote,

“(Weissman) assured me that the mice did not suddenly start acting human. 'There were no requests for coffee from Minnie,' he said. 'The total number of human brain cells in the mouse brain was less than one in a thousand. I don’t think we would get a mouse with a full human brain. And even if the mouse made it to a human mouse it would still have a mouse-brain offspring.'”

Legal Wheels Turn: Ban on hESC Funding Temporarily Removed

The nation's stem cell scientists received a reprieve today, courtesy of a federal appellate court that put a hold on an earlier order to halt federal funding of hESC research.

Gardiner Harris of the New York Times wrote:

"The appeals court ruling could save research mice from being euthanized, cells in petri dishes from starving and scores of scientists from facing a suspension of paychecks, according to arguments the Obama administration made in the case. It could also allow the National Institutes of Health to provide $78 million to 44 scientists whose research the agency had previously agreed to finance."

Rob Stein and Spencer S. Hsu of the Washington Post wrote:

"(T)he appeals court made it clear it was not making a final decision about the case, which means the reprieve could be short-lived and the fate of the funding could continue to be whiplashed by seesawing court rulings."

The next court action is not expected to come until sometime after Sept. 20, the deadline for filing additional arguments in the case.

The legal brouhaha makes clear several facts concerning research funding. If you are a scientist, your research is not secure unless you are paying for it yourself. NIH funding is subject to the vagaries of the courts and Congress. Private funding comes with its own set of strings, which generally are not revealed to the public, but they are there. And despite the assurances of the California stem cell agency, its funding can be threatened under some circumstances, as we saw in 2009. CIRM's resources are clearly subject to the state's ability or desire to borrow money and issue the state bonds that are the agency's only real source of cash.

Media Coverage: Political and Research Implications of hESC Ruling

Here are some excerpts and links to interesting coverage of yesterday's federal court ruling on stem cell research.

Text of the judge's ruling from the Washington Post.

Wall Street Journal, reporters Laura Meckler, Gautam Naik and Brent Kendall on election year politics and more.

"It also could inject the divisive issue into election-year politics and spark discussion in Congress whether to try to nullify the decision by writing new legislation.... 

"The government is spending about $137 million on human embryonic stem cell research this year and is projected to spend about $126 million next year. It's unclear whether the judge's decision would affect currently funded projects. Stem-cell advocates were calling on the government to appeal the decision and seek to have the preliminary injunction nullified....

"A significant amount of stem-cell research will go forward thanks to private funding and the state of California's ambitious stem-cell initiative, which isn't affected by Judge Lamberth's ruling. The California group (CIRM) spends $250 million annually on stem-cell research, with some 30%-40% of the money directed to embryonic stem-cell research."

Los Angeles Times, reporters Karen Kaplan and Naom Levy, on legal view of ruling.

"UCLA law professor Russell Korobkin, an expert on stem cell legal issues, said the ruling was "a terrible decision."

“By considering all research part of an unbreakable continuum, the decision implies that the Dickey-Wicker Amendment has no limits, which is an unconvincing interpretation, Korobkin said. 'It suggests that by conducting research on an acorn a scientist would also be conducting research on an oak tree, because acorns come from oak trees,' he said.”

New York Times, reporter Gardiner Harris, on feeding stem cells and politics of the decision.

"'I have had to tell everyone in my lab that when they feed their cells tomorrow morning, they better use media that has not been funded by the federal government,' said Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, referring to food given cells. 'This ruling means an immediate disruption of dozens of labs doing this work since the Obama Administration made its order.'

“In his ruling, Chief Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia wrote that his temporary injunction returns federal policy to the “status quo,” but few officials, scientists or lawyers in the case were sure Monday night what that meant. Dr. Daley was among those who said they believed that it meant that work funded under the new rules had to stop immediately; others said that it meant that the health institutes had to use Bush Administration rules to fund future grants....

“The ruling could prove politically tricky, since it returns to public attention the politically divisive issue of abortion and research politics. President Obama made support for the research a signature part of his campaign, and he over-turned the Bush Administration’s more restrictive policy in the first two months of his administration.

“Polls show that the public generally supports embryonic stem cell research, and Judge Lamberth’s ruling — while a surprising legal setback for one of the administration’s signature scientific policies — could prove politically beneficial for the administration by reminding votes of a popular decision.”

CIRM still open for business -- Ron Leuty, San Francisco Business Times, The Associated Press(AP story appeared in The Sacramento Bee, San Diego Union-Tribune and other papers)

Washington Post story, reporters Rob Stein and Spencer Hsu

"'This is devastating, absolutely devastating,' said Amy Comstock Rick, immediate past president of the Coalition for the Advancement of Medical Research, a group of patient organizations that has been lobbying for more federal funding.

"'We were really looking forward to research finally moving forward with the full backing of the NIH. We were really looking forward to the next chapter when human embryonic stem cells could really be explored for their full potential. This really sets us back,' Rick said. 'Every day we lose is another day lost for patients waiting for cures.'"

CBS News on ruling and “snowflake adoptions”

California Stem Cell Agency Deplores Ruling Nixing Fed hESC Research

A federal judge today put a temporary halt to federal funding of research involving human embryonic stem cells in a move that makes clear the importance of alternative funding sources such as the California stem cell agency.

Some had questioned the relevancy of the state's $3 billion research effort after the Obama administration restored cash for hESC grants. Critics said California was no longer needed because the feds were back in the game. But despite the ruling today, the state can proceed with its research because it is not constrained by the federal law cited in the court action.

Today's ruling is not a final decision in the case and is likely to be appealed. But it could mean that NIH funding in this controversial area will be stymied for some time, depending on the legal skills of its attorneys. Meanwhile, California will remain the largest source of hESC funding in the nation, although it has been moving into other areas as well. In fact, some have criticized the agency for not continuing to focus intensely on hESC research, which was the justification for spending $3 billion that was presented to voters in 2004.

In a statement, CIRM said it “deplored” the ruling, declaring that it was “immoral.” CIRM said its research would continue unabated, but noted that today's ruling will have a major negative impact elsewhere.

CIRM President Alan Trounson said,

“The decision is a deplorable brake on all stem cell research. Many discoveries with other cell types, notably the so-called reprogrammed iPS cells, would not happen without ongoing research in human embryonic stem cells. This decision leaves CIRM as the most significant source of funding for human embryonic stem cells in the U.S.”

CIRM Chairman Robert Klein said,

“It would be immoral to unnecessarily delay the critical medical research that is vital for human embryonic stem cell therapies to reach patients suffering from chronic disease and injury. We must remember that the microscopic cells used for this research would otherwise be thrown away by in vitro fertilization clinics, by couples that had finished their family planning.”

CIRM's statement said,

“Under this decision, even research using on the hESC lines approved by President George W. Bush will be halted.

“However, CIRM will continue to fund research on all hESC lines recognized by the Bush administration as well as newer lines approved by the National Institutes of Health during the past eight months. This points to the importance of CIRM’s California model of sustained funding in this field that promises to create thousands of jobs in California as well as improved therapies for patients in Californian and around the world.

“With federal funding uncertain, CIRM will continue providing a stable source of funding for those researchers who have committed their labs to pursuing new therapies based on work with human embryonic stem cells. Through this ongoing funding, CIRM expects to be able to continue to leverage California’s investment through its Collaborative Funding Partners, grant-making agencies in seven countries and Maryland and New York.”

The statement continued,

“CIRM will also continue to fund research with other types of stem cells, particularly progenitor cells that can create many cell types and other pluripotent cells such as induced Pluripotent Stem cells (iPS cells). However, it is important to note that work in all these cells types requires insights gained through work with hESCs to proceed with maximum efficiency. hESC research informs the entire field.”

Oral Appellate Arguments Set for February in California Stem Cell Lawsuit

Don't expect a stem cell love feast on Valentine's Day in the Court of Appeals in California.

That is when foes of the California stem cell agency will go toe-to-toe with state attorneys during oral arguments as the opponents seek to put CIRM out of business. The foes lost during a superior court trial last year and are now appealing that verdict.

An appellate decision could come in a matter of a few weeks following the Feb. 14 hearing, but given the nature of the legal beast, it probably will be later. Then there is likely to be an appeal to the State Supreme Court, where the case is almost certain to terminate, probably before the end of the year.

Oral arguments will begin at 9 a.m. in the First Appellate Court at 350 McAllister St. in San Francisco.