Friday, April 25, 2008

Fresh Links

We have added The Niche and Nature Reports Stem Cells to the links on this Web site, a long overdue addition. They are very much worth reading. We have also updated the link to Consumer Watchdog(formerly known as the Foundation for Taxpayer and Consumer Rights).

Please let us know if you know of Web sites that you would like to see added as links.

Thursday, April 24, 2008

Growing an Arm, a Leg and an Ear

Some of you may have wondered about the "Veterans for Cures" effort by Robert Klein's private advocacy group mentioned in the item below.

Here is what it is likely linked to – a $250 million military effort to grow body parts or at least the thinking behind it.

U.S. Army Surgeon General Lt. Gen. Eric Schoomaker (see Defense Department photo above) earlier this month told reporters about how researchers are growing a new ear for a Marine, using stem cells from his own body. Reporter Lisa Burgess of Stars and Stripes reported that the Schoomaker said,
"It's like baking a cake."
So far none of the military cash is slated to go to California, but that could change as researchers here see the potential for grant funding.

Here is another piece on the Defense Department program on a blog by a Belgium consulting firm, Pantopicon.

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society has left a new comment on the Flamm item below. Among other things, she says there were a number of concerns with the Cha grant that were not mentioned in the item about Flamm. She is absolutely correct. We also did not mention that CIRM's scientific reviewers had no idea of the controversy surrounding Cha when they approved the grant. The scientific reviewers knew the name of the applying organization at the time of the review but it was kept secret from CIRM directors when they later ratified the reviewers' decision in public session. That secrecy is part of the official CIRM process. One CIRM official told us later that the Cha grant would not have been approved by the scientific panel if they had been informed of the controversy.

Klein's Private Group Plans Expanded National Stem Cell Push

Americans for Cures, the private stem cell activist group tied to the chairman of California's governmental stem cell agency, is embarking on a new, 50-state strategy to beef up efforts to "pass pro-cures legislation and defeat anti-cures legislation."

The advocacy group, which says that it does not perform lobbying, says it is setting up affiliates in each state and wants to hear from persons who want to help out (write inform@americansforcures.org).

Complete details for the national effort are being worked out, but Americans for Cures plans to create a Web page for each state affiliate (here is a sample) along with a rundown on the status of research and that state's laws. The affiliate would be "a single point of contact in each state, and may be one person or a group. That point will be the ‘network hub' for stem cell advocacy, to keep us informed, and to organize in the affiliate state," the co-directors of the group, Amy Daly and Constance McKee, said in an email to their supporters.

The group is also planning a "Students for Cures" group and a "Veterans for Cures" group.

The chairman of CIRM, Robert Klein, is also president of Americans for Cures, which operates out of the offices of his real estate investment banking firm. It is unusual for a top state official to lead a group that solicits possibly tax-deductible contributions and attempts to influence government policy and legislation in the same area as his agency. More than one critic has called on him to resign from one of the posts.

(On a slightly different subject, Americans for Cures' new website has some videos involving persons with a variety of ailments. We watched the Alzheimers segment. It was quite powerful.)

San Diego UT: Down with Gliders, Up with ESC


"Lamentable in the extreme" – that's how the San Diego Union-Tribune characterizes the opposition of glider airplane fans to the $115 million stem cell research facility proposed in La Jolla.

The lab is being planned by the San Diego Consortium for Regenerative Medicine, which wants $50 million from the California stem cell agency to help build it.

An editorial in the San Diego paper this week cited the "enormous potential" for development of therapies at the laboratory and said,
"It would be a tragedy of enormous proportions if glider advocates succeeded in snuffing out this promising initiative."
It should be noted that embryonic stem cell research is a hot issue in the San Diego area, which has a strong, conservative element. The newspaper's editorial on behalf of the consortium did not contain the word "embryonic," which we assume is deliberate, although the newspaper has supported embryonic stem cell research in the past.

The editorial also contained more details on the opposition. It said:
"The Associated Glider Clubs of Southern California and the Torrey Pines Soaring Council are attempting to kill the project because it would be built on North Torrey Pines Road near the Torrey Pines Gliderport(see photos from the Associated Glider Clubs). The unpaved airstrip, on land owned by UCSD, is used intermittently by glider pilots, while a larger number of hang-gliders use the nearby cliffs to launch into flight over the Pacific.

"The new research lab, about 60 feet tall, would have no impact on the hang-gliders. But there is fierce disagreement over whether it would interfere with conventional glider operations, which are relatively few and scattered throughout the year.

"Opponents claim the new building would force closure of the gliderport, an assertion they also made unsuccessfully in their bid to prevent UCSD from building a 14-story dormitory on a nearby parcel. Supporters of the lab point out, however, that it would be no taller than the surrounding eucalyptus trees, which glider pilots have been negotiating for years. An environmental impact report compiled for UCSD concludes the lab would not prompt the end of glider operations, but that it could require pilots to alter their flight patterns. In the end, both the California Coasstal Commission and Caltrans' aeronautic division must issue permits for the lab's construction."
The newspaper also printed two letters concerning the project , including one from Rolf Schulze, president of the Associated Glider Clubs of Southern California. He commented on the meeting Monday night on the environmental impact report for the laboratory, which the newspaper did not cover. Schulze said:
"Some speakers in opposition to the location of the stem cell facility not only mentioned their vote for the stem cell initiative in 2004 but also their personal interest in the anticipated benefits of such research due to their own, or a relative's illness, which could perhaps be cured.

"UCSD owns many other nearby sections of land that would be even more suitable for the stem cell facility, while not resulting in the destruction of a world-renowned and historic aviation facility used by Charles Lindbergh and many other aviation pioneers."

Tuesday, April 22, 2008

Chippewa to San Francisco: The $758 Million Stem Cell Media Challenge

The Associated Press files stories every day to 1,700 newspapers and 5,000 radio and television outlets in the United States. So when it reports on California stem cell news, the stories have an impact – one that goes well beyond, shall we say, the surf-scrubbed sands of La Jolla.

The case in point is an article by reporter Terri Somers of the San Diego Union-Tribune, the most diligent biotech reporter in the state. She writes more often on biotech and stem cell research than any other newspaper reporter in the state.

But her stories usually are only seen – at least the print versions -- in San Diego, far from the key East Coast news axis of New York and Washington, D.C.

However, she wrote Sunday about a $115 million stem cell research complex proposed in La Jolla – a structure that could be funded with as much as $50 million from the California stem cell agency.

The AP decided to pick up the story – rewrite it in a much shorter version, but without crediting Somers or the San Diego paper – a standard and legal practice for the news service. The AP then sent the story out across a good portion of the globe. It appeared on websites of more than 100 news outlets ranging from Dallas to the UK. Time magazine carried it as did ABC, CBS, Forbes, the Washington Times, an Arizona TV station, a Florida newspaper, CTV in Canada, FoxNews, not to mention the Chippewa Herald in Wisconsin.

The AP missed the much larger story – that the California stem cell agency is about to set off a $758 million, stem-cell-lab-building spree, the likes of which have never been seen before in this country. But that is not to disrespect The AP, but to explain a little bit about how news works.

It takes a lot to push a story out into the national or international market. It also takes luck and receptive reporters and editors. The California stem cell agency, however, has a chance to make major headlines come May 6 when it approves a couple hundred millions of dollars to help build those nearly three-quarter-of-a-billion dollars in labs.

But CIRM can only do it by starting to prime the news pump now, alerting key reporters and editors and providing them in advance with the background needed to make sense out of a somewhat complex process: Photos, drawings, map and chart material, good quotes (not the gobbledygook that sometimes comes out of the mouths of some top CIRM officials) and referrals to knowledgeable and friendly third party experts who can explain the significance of the effort in language that readers can understand.

In California, the mainstream media has so far successfully largely ignored the lab grant program, with the notable exception of Somers. Ironically, the San Diego project, while quite substantial, is not the largest. Stanford has proposed a $200 million stem cell research center. The San Francisco Bay area altogether could see something like $400 million in stem cell lab construction if the visions dancing in the heads of the scientists materialize. But nary a peep about the magnitude of the program has been seen in the mainstream media in Northern California.

Meanwhile, Somers, who like most reporters is undoubtedly underpaid and under-appreciated, will have to be satisfied with the psychic reward of seeing her work spread, albeit anonymously, throughout the world.

Fresh Comment

A statement from Kwang-Yul Cha's attorney has been posted as a "comment" on the Flamm item below.

Monday, April 21, 2008

Stem Cell Watchdog Begins Third Year

The Consumer Watchdog group and its stem cell project director, John M. Simpson, have won another $100,000 grant to continue monitoring the California stem cell agency and to expand their efforts into other states.

The Nathan Cummings Foundation is providing the funding for the Consumer Watchdog effort for the third consecutive year, Simpson said.

The latest grant, however, calls for Simpson (see photo) to move beyond California and take a crack at stem cell research efforts in other states as well as publicly funded medical research on a national level.

The grant application said Consumer Watchdog combines "policy research and focused legal and media advocacy to ensure transparency standards, conflict of interest prohibitions, public benefit requirements and other safeguards are in place to protect consumer interests and to maximize consumer access to medical advances resulting from public funding."

Simpson, a former top level newspaper editor, ranks among the most regular attendees at CIRM meetings and has a wide range of contacts in the California stem cell community.

At the January meeting of the CIRM Oversight Committee, one member of that panel, Joan Samuelson, spoke up after Simpson disclosed his group's stem cell funding sources and plans for 2008. She told Simpson,
"I'm glad you're here.... I thank him for his hard work and contribution to what we're doing toward the mission. I think you're an important element. We need the oversight."

Flamm Wins Latest Round Against Korean Stem Cell Researcher

Remember the case of Korean stem cell scientist Kwang Yul Cha versus a California physician?

Cha sued Bruce Flamm, a Kaiser physician and faculty member at UC Irvine, for libel, contending that Flamm was engaged in a personal vendetta. The lawsuit involved published criticism by Flamm of a 2001 article by Cha and two others in the Journal of Reproductive Medicine concerning "distant" prayer and IVF success rates.

Today a Los Angeles superior court judge dismissed Cha's lawsuit. Flamm said in a news release:
"Today's ruling is a victory for science and freedom of speech. Scientists must be allowed to question bizarre claims and correct errors.

"Cha's mysterious study was designed and allegedly conducted by a man who turned out to be a criminal with a 20-year history of fraud. A criminal who steals the identities of dead children to obtain bank loans and passports is not a trustworthy source of research data. Cha could have simply admitted this obvious fact but instead he hired Beverly Hills lawyers to punish me for voicing my opinions."
Cha also surfaced in connection with the California stem cell agency when a nonprofit subsidiary of his organization won a research grant from CIRM. After the grant was approved, the media reported its links to Cha along with news about the controversy surrounding some of Cha's research. Last October, Cha's group withdrew its application for the CIRM grant.

It was not known whether Cha plans to appeal the latest ruling.

Correction

The item below incorrectly described tonight's meeting concerning the San Diego consortium's plans as a "protest" meeting. It is actually a meeting called by the consortium as part of the environmental impact process. Protesters are expected to be there.

Sunday, April 20, 2008

San Diego Consortium's Stem Cell Lab Plans and How They Came About

The folks in San Diego call it a "collaboratory" – a $115 million structure to be built under the auspices of four of the world's stem cell research powerhouses.

They are the Scripps, Burnham and Salk institutes and the University of California campus at San Diego – all united under the banner of the San Diego Consortium for Regenerative Medicine.

Reporter Terri Somers of the San Diego Union-Tribune Sunday took a front-page look at the project (see drawing), which is seeking $50 million in construction funding from the California stem cell agency. It is scheduled to make decisions in early May on grant applications from throughout California that would led to $758 million in stem cell lab construction.

Somers story was chockablock with interesting stuff. She wrote:
"It took three men the scientists fondly refer to as 'the town elders' – real estate mogul Malin Burnham, Padres owner John Moores and Qualcomm founder Irwin Jacobs – to help it become a reality.

"'Without their pressure, encouragement and support, (the consortium) wouldn't have happened,' said Fred Gage, a stem cell researcher at Salk."
(Moores was a key financial supporter of CIRM, purchasing $2 million in bond anticipation notes from CIRM when its finances were tied up in litigation.)

Somers also reported,
"An out-of-state philanthropist, whom the consortium declined to identify, has pledged to donate $30 million, with $10 million paid upfront. The remainder would be in $2 million annual increments."
Somers said that Moores gave the consortium $250,000 in seed money and requested the institutes come up with $50,000 each. The 7.5 acres for the building comes from UCSD and is valued at $15 million,

She reported that collaborative efforts sometimes have had difficulty in the past, including one involving UC San Francisco and Stanford. Somers wrote,
"The difficulties arise from every institution having its own culture. Smaller institutes relish their autonomy and operating freedom in contrast to larger, more bureaucratic institutions, such as UCSD.

"Issues ranging from who will be the boss to fear of losing donations, or disputes over who will own scientific discoveries, often kill such partnerships before they start, said Zach Hall, founding president of the California Institute for Regenerative Medicine.

"'It's a testament to the vitality and sense of community that is in San Diego that this has happened,' said Hall, who is now retired. Three years ago, when putting together the strategic plan for the state stem cell institute, Hall listed fostering collaboration as a top goal.

"'For these San Diego institutes to overcome all the obstacles is a real payoff for the long-term vision that San Diego had years ago in setting aside some space for the development of scientific activities,' he said."
CIRM scientific reviewers ranked the project at the top of the 12 lab grant applications. Facilities reviewers ranked it No. 4.

However, that does not matter much to some folks who are not pleased about the project. They say it would mean the end to the Torrey Pines Gliderport, which is in the National Register of Historic Places. A meeting is scheduled for Monday night at which some of the concerns of the glider folks are expected to be aired. In Napa, some 600 miles to the north, on Wednesday night, the state Historical Resources Commission will consider whether to expand the borders of the Gliderport.

Somers story picked up some reader reaction on the Internet, which can be found at the end of her story or here. One reader complained about "greedy scientists fighting over patents." Another decried "welfare for professionals in these lean financial times." One reader suggested the lab be located inland in El Cajon to save money. Responded another reader, "All the Right Wing Christian Coalition fanatics in that town would chase them out. EL Cajon is only known for strip bars, meth dens and a nut case mayor."

(An earlier version of this item described the Monday meeting involving the gliderport as a protest meeting. The meeting is actually part of the EIR process.)

Saturday, April 19, 2008

Fresh Comments

John M. Simpson, stem cell project director for Consumer Watchdog, has posted a comment on the item below. We have also posted a note concerning his item.

Klein Group Says It Does Not Lobby

The American for Cures Foundation, whose president, Robert Klein, is chairman of the $3 billion California stem cell agency, has taken issue with our description of it as a lobbying group.

Amy Daly, executive director of the group, says that it does not lobby and that the California Stem Cell Report is reporting inaccurately.

She sent along the following from co-executive director Constance McKee:
"At your(Daly's) request, I have carried out additional research on Mr. Jensen’s 'definition' that would include our work as a lobbying firm. We do not make representations directly to Congress or its committees, nor do we ask for or accept any fees on behalf of others to do so. We educate individuals as to science and issues, and suggest how they themselves can advocate for stem cell research..... I could find no legal or tax definition under which our activities could be accurately described as 'lobbying.'

"You might be interested in the Supreme Court’s narrow definition of lobbying. Clearly that is not what we do.

"'The U.S. Supreme Court has rejected congressional efforts to regulate grassroots communications as a form of 'lobbying,' on constitutional grounds. In 1953, in a suit involving a congressional resolution authorizing a committee to investigate 'all lobbying activities intended to influence, encourage, promote, or retard legislation,' the Supreme Court narrowly construed 'lobbying activities' to mean only 'direct' lobbying (which the Court described as 'representations made directly to the Congress, its members, or its committees'), and rejected a broader interpretation of 'lobbying' out of First Amendment concerns. [United States v. Rumely, 345 U.S. 41 (1953).]"
Americans for Cures is obviously relying on a narrow legal definition of the word lobbying. However, lobbying has broader meaning. Merriam Webster's Third Unabridged Dictionary notes that lobbying includes conducting "activities (as engaging in personal contacts or the dissemination of information) with the objective of influencing public officials."

The legal definition of lobbying is of great importance to Americans for Cures. Too much lobbying could lead to a loss of its nonprofit status, according to the Nonprofitexpert.com web site.

Nonetheless Americans for Cures makes it clear on its web site that its goals include influencing public policy, declaring that it seeks to help "encourage" decision-makers to fund stem cell research. Indeed, Daly appeared briefly before the CIRM Oversight Committee in January and addressed the question of how the committee should proceed in handling an attempt to overturn a negative decision on a grant application. The group's recent conference in San Francisco promised attendees that they would be taught how "key federal and state programs are funded, and what they can do to make their voices heard," including "specific actions" that advocates "can take to accelerate research and cures."

Some people thing that lobbying is pernicious. We do not. The problems with lobbying result from poor ethical practices, abuses related to power and money and the failure to consider all points of view. Citizens, businesses, nonprofit organizations and other groups can and should be deeply involved in the governmental process. The voices of all are needed in order to formulate the best laws, regulations and policies.

Friday, April 18, 2008

Fresh Comment

"Anonymous" has posted a new comment on the "not so trivial" item below.

Fresh Comment

Jeff Sheehy, a member of the CIRM Oversight Committee, has posted comment on the item below. We have posted a response to his comment. "Anonymous" has also posted a comment on the "political manipulation" item.

Thursday, April 17, 2008

CIRM Says: Not So Trivial

The California stem cell agency is defending its statement last week concerning clinical trials stemming from agency-funded research and denies that it put out a press release on the subject.

The comment came from Don Gibbons, chief communications officer for CIRM, in a comment on the Consumer Watchdog web site. Gibbons' comment was directed at the Consumer Watchdog news release that said CIRM funding for the research was trivial (see item below).

Gibbons said,
"Anyone who truly understands how research labs function would not call the CIRM training grant a trivial contribution."
Gibbons continued,
"Also, it should be noted that CIRM did not write a press release or send anything to reporters."
The document put out by CIRM can be found on the "press room" section of the agency's website under 2008 "press releases."

Gibbons' entire comment can be found on the Consumer Watchdog blog under the comments section following the news release by John M. Simpson, the group's stem cell project director.

Wednesday, April 16, 2008

CIRM Charged with Political Manipulation

The California stem cell agency is "too eager to claim immediate results" from the hundreds of millions of dollars in research that it is funding, the Consumer Watchdog group said today.

John M. Simpson, stem cell project director for the group, said,
"CIRM is jumping on the bandwagon claiming credit for contributions that were at best rather trivial."
Simpson was commenting on the report below – "CIRM Exaggerates Role..."

He said,
"CIRM is too eager to claim immediate results. Certainly we’ll see great benefit as the result of stem cell research, but this political manipulation and hype does a tremendous disservice to all who believe in the value of this research."
Simpson's news release continued:
"Stem cell agency officials repeatedly say, ‘It’s all about the science. If only that were true. More often than not — as in this case — it’s all about appearances, hype and claiming credit."

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society has posted a comment on the item below.

You can read it by clicking on the word "comments" at the end of the item. You can also make a comment by the same method.

Tuesday, April 15, 2008

CIRM Exaggerates Role in San Diego Clinical Trials Research, Scientist Says

The headline last week from the California stem cell agency read: "First Clinical Trial Begins for a Therapy Enabled By CIRM Funding."

The news was big enough that California Gov. Arnold Schwarzenegger issued a statement on April 7, hailing the research as a world-leading effort. The governor said,
"Stem cell research, funded by the California Institute for Regenerative Medicine (CIRM), led to the discovery of this new treatment."
CIRM Chairman Robert Klein touted "the CIRM model designed to accelerate the quest for cures." The news also received attention in some newspapers, including the San Diego Union-Tribune.

But at least one well-regarded, California stem cell researcher thinks the agency engaged in exaggeration – perhaps even "fraud" – in making the claims about the role of its funding.

The researcher, who asked not to be identified, told the California Stem Cell Report:
"It appears as though the CIRM has wrongly taken credit for supporting work published by one of its funded grantees and/or the funded grantee has wrongly given credit to CIRM for supporting their research. In either case, the CIRM’s press release on the subject is self-serving and misleading, at best. The press and hESC stem cell research supporters have already latched on to this false claim by CIRM and, as a result, are mistakenly touting CIRM’s effectiveness in the field."
CIRM has defended its statement, which said,
"Researchers at the University of California, San Diego, used a (CIRM) SEED grant from the California Institute for Regenerative Medicine to conduct stem-cell research that verified a suspect gene mutation was by itself necessary and sufficient to cause a class of severe blood diseases called myeloproliferative disorders."
The CIRM statement, which is carried under the press release section of its web site, was modified following queries by the California Stem Cell Report. The release now says that a CIRM training grant was also involved. The current version of the news release, however, does not mention that it was altered from the original.

The initial version of the CIRM statement reportedly triggered concerns among some stem cell scientists and led to one contacting the California Stem Cell Report.

The researcher said in an email:
"The press release 'First Clinical Trial Begins for a Therapy Enabled By CIRM Funding' states that 'Researchers at the University of California, San Diego, used a SEED grant from the California Institute for Regenerative Medicine to conduct stem-cell research …'. The quoted UCSD press release describes the work as involving 'human cord blood stem cells … to find whether over-expression of a single gene could drive, or initiate, the disease … that looked like PV' and says that the '…work [was] supported in part by grants from the California Institute for Regenerative Medicine…'. Both items in the UCSD press release are corroborated by inspection of the Cancer Stem article cited.

"However, the SEED grant mentioned - RS1-00228-1: Derivation and Characterization of Cancer Stem Cells from Human ES Cells – has nothing to do with cord blood stem cells or PV. The SEED grant involves hESCs and another disease altogether, CML: 'To provide a robust model system for screening novel anti-CSC therapies, we propose to generate and characterize CSC from hESC (10-18). We will investigate the role of genes that are essential for initiation of CML such as BCR-ABL and additional mutations such as b-catenin implicated in CSC propagation (19-30).'

"Thus, any claim that the SEED grant monies were used to support the published research is either in error, an over-exaggeration, or, worse, fraud.

"CIRM needs to investigate which of these possibilities is the correct one, issue a retraction of its claim, and ensure that erroneous claims are no longer proffered by CIRM or its grantees."
The research in question was conducted at the University of California, San Diego, by a team led by Catriona Jamieson. Her article in Cancer Cell said in the acknowledgments section that:
"This work was supported in part by grants from the California Institute for Regenerative Medicine and the Mizrahi Family Foundation to E.K., C.B., and C.H.M.J., the National Institutes of Health (K23HL04409) to J.G., and an unrestricted gift from Targe-Gen Inc."
When queried, Don Gibbons, chief communications officer for CIRM, said,
"Jamieson has had a post doc funded by a CIRM training grant since July 2006, so our funds helped every stage of this work through his salary. The SEED grant to Jamieson was approved in February (2007) and the Notice of Grant Award went to the institution in July. It is typical for institutions to forward fund after an NGA pending arrival of the first check, which happened in September. The journal asked for additional experiments after the initial submission of the paper, and the Seed grant helped complete those added experiments that resulted in final publication.

"The SEED grant does require that Jamieson use embryonic stem cells at some point during the two year grant cycle, but it also funds many other aspects of the science. Our scientific strategic plan does not call for just funding stem cell work directly; it calls for accelerating the field as a whole."
Gibbons later said that UCSD provided no advance funding for the CIRM grant, which was not signed off by UCSD until Aug. 31, 2007, according to another source. Jamieson's article was first submitted for publication Sept. 19, 2007, according to the source.

We asked Jamieson if she had any comment on the CIRM news release issue. She simply referred us to the statement contained in the acknowledgment section of her Cancer Cell article.

The stem cell researcher who is critical of CIRM said that "...because (the agency) perceives a need to produce results rapidly (it) has, perhaps inadvertently and perhaps not, latched on without checking the facts (although in my mind the facts are quite obvious and need little checking)."

Monday, April 14, 2008

Fresh Comment

"Vanessa" has posted a new comment on the "egg donation" comment item.

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