CIRM Press Release on Grant Program

Here is the press release from CIRM on its new grant program.

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Contact: Kirk Kleinschmidt, (415) 396-9100, kkleinschmidt@cirm.ca.gov

OVERSIGHT BOARD APPROVES PROPOSAL FOR NEW HUMAN EMBRYONIC STEM CELL RESEARCH PROGRAM

Governor Schwarzenegger-Authorized Loan Allows Science to Move Forward

San Francisco, August 2, 2006—Twelve days after Governor Arnold Schwarzenegger’s announcement of a $150 million loan to the California Institute for Regenerative Medicine (CIRM), its oversight board responded with a new proposal funding human embryonic stem cell research at California’s non-profit research institutions.

The Independent Citizens’ Oversight Committee (ICOC) approved a proposal for three Requests for Application (RFAs):

Comprehensive Research Grants—four-year grants to investigators with a record of accomplishment in human embryonic stem cell research or closely-related field that relate to a long-term therapeutic goal;
Seed Grants—two-year grants to fund innovative ideas by scientific investigators who are new to the field;
CIRM Shared Research Laboratory Grants—grants for dedicated laboratories for culturing human embryonic stem cells including core equipment and trained personnel. Additional grants in this category will be made for a course to teach culturing methods.
All grants will be made on a competitive basis to ensure that the best scientific proposals are funded. The ICOC will approve all funding decisions following scientific peer review and recommendations by the Scientific and Medical Research Funding Working Group and the Facilities Working Group, as appropriate.

“The Governor’s commitment to this science has electrified the field and given hope to millions that the promise of stem cell research will move forward in California,” said ICOC Chairman Robert Klein. “The board’s decision to focus on human embryonic stem cell research will address the critical funding gap created by the paralysis of federal policy.”

Topics to be considered in the new RFA will include but are not limited to:

Self-renewal and differentiation of human embryonic stem cells;
Derivation of new human embryonic stem cell lines, including disease-specific lines;
Assessment of tumorigenicity of human embryonic stem cells and derived cells;
Reprogramming of adult human somatic nuclei;
Studies related to identification, storage, maintenance, stability and storage of human embryonic stem cells.
“The board’s decision will allow CIRM to jump-start human embryonic stem cell research in California,” said CIRM President Zach Hall. “We have the infrastructure and policies in place to manage this exciting program in a responsible way for the people of California. We can now advance the goal set by California voters—funding the best science that leads toward therapies.”

Human Embryonic Stem Cell Research Program
Preliminary Budget
Year 1
$69.5 million
Year 2
$37 million
Year 3
$25 million
Year 4
$20 million
Total
$151.5 million

The first two years of the Human Embryonic Stem Cell Research Program is intended to be funded from the loan from the State of California initiated by the Governor. The anticipated general obligation bonds will fund years three and four of the program. An additional RFA, also to be funded by the State loan, is expected later this year to address adult, cord blood and other critical stem cell research.

The ICOC wrote a mission statement, guiding values and strategic principles for the scientific strategic plan, which is scheduled to be presented for formal approval at the next board meeting in October. The board created a slogan for the program: “Turning stem cells into cures.”

The board also approved final regulations for Medical and Ethical Standards to guide CIRM-funded research and conflict of interest regulations for advisory working group members. They will have the force and effect of California law pending final review and publication by the California Office of Administrative Law.

From Dollar Signs to Stem Cells: Diverging Views on WARF Patents

The matter is no mere piffle in Wisconsin. Just something in the neighborhood of $200 million a year from California alone, according to a story in the Milwaukee Sentinel Journal.

But out in California the issue is even greater.

"What's ultimately at stake is control of a potential billion-dollar industry that could make therapies to treat some of the world's most devastating diseases," wrote reporter Terri Somers of the San Diego Union Tribune on July 30.

What she and reporter Kathleen Gallagher of the Milwaukee paper referred to was the patent rights of the Wisconsin Alumni Research Foundation on embryonic stem cells. The two reporters raised the level of public attention to the dispute over the WARF patents with their lengthy pieces on a subject that is rarely reported by the mainstream media. Both articles were triggered by challenges to WARF by the Foundation for Taxpayer and Consumers Rights in California and the Public Patent Foundation in New York.

The stories covered some familiar ground to the readers of this blog. But we found it interesting that the Milwaukee paper cited the example of the patenting of recombinant DNA to support the WARF position while the San Diego paper cited the same patents as supporting the anti-WARF position.

Gallagher wrote on July 23:

"Stanford University also required upfront licensing fees on its recombinant DNA patents granted in 1980. Those fees were detailed in a paper that Maryann Feldman of the University of Toronto and two others published in November."

Gallagher continued:

"Stanford's recombinant DNA patents are just as broad as WARF's.

"Stanford pulled in $254 million of revenue on the patents, which it licensed to 468 companies, including Amgen and Genentech, that developed therapeutic products such as human insulin, human growth hormone and interferons based on the technology, according to the Feldman paper."

Somers in San Diego wrote:

"The WARF patents are much more expensive to use than some of the pioneering patents that have come before it – including at least one that was essential in the creation of the world's biotechnology industry.

"In 1980, Stanford University and the University of California system patented recombinant DNA, the process of splicing genes from one cell into another. It was one of two pivotal patents that gave birth to biotech.

"The Cohen/Boyer patents were broad in their scope, but Stanford and the UC system made a decision to license widely and cheaply to early biotech companies and to make the technology available without charge to universities and nonprofit institutes.

"Biotechnology companies grumbled at the time about having to pay $10,000 for the science, but it was much cheaper to buy the license than to fight it in court, ong>(John) Wetherell (an intellectual property attorney with Pillsbury, Winthrop, Shaw and Pittman in San Diego) said.

"The result was that more than 350 companies took licenses, the universities made $255 million and the public got the benefit of the products that were developed, (Cathryn) Campbell (an intellectual property lawyer with Needle and Rosenberg in San Diego) said."

Another interesting divergence emerged concerning reach-through royalties.

Somers quoted Joydeep Goswami, Invitrogen vice president for stem cells and regenerative medicine, on the subject.

"WARF has what he called 'a reach-through royalty clause, where they say anything you've invented remotely by using human embryonic stem cells will now have a royalty obligation back to WARF.'

"For example, if Invitrogen uses embryonic stem cells early in the development of a tool for drug discovery but the production of the tool doesn't involve stem cells, WARF would still want royalties on the tool, he said.

"WARF also wants companies with licenses to pay royalties on products they sell in foreign markets that don't honor the patents, Goswami said. That would give an advantage to companies overseas, which can develop the same tools without owing money to WARF.

"(Elizabeth) Donley (WARF general counsel) denied that WARF charges the reach-through royalties, although many scientists, business executives and intellectual property experts cite them.

"The bottom line, Donley said, is that the incentive for receiving a WARF license is the ability to do business in the United States, the world's largest drug market.

"'They are building a program using our patent. You can't build a program on our patents and pay us nothing,' Donley said. 'Who has dollar signs in their eyes now?'"

Gallagher's story also noted the broader impact of the patent issue, declaring that it "signaled increasing awareness among scientists and companies that the Wisconsin Alumni Research Foundation's patents make this state the biggest interchange through which all stem cell commercialization must travel."

She reported that WARF says it has provided licenses and cells to 324 research groups at no charge" and "provided licenses and cells to 12 commercial users. Those users pay fees ranging from $75,000 to more than $250,000, plus annual royalties."

The estimate of $200 million potential revenues from California came from Gallagher's story. She attributed the figure to Peter Balbus, managing director at Pragmaxis LLC, a company in Glen Ellyn, Ill., that helps commercialize technology.

By the way, the Wisconsin State Journal in an editorial basically dismisses the WARF patent debate as a "load of bunk."

NY Times: Stem Cell Research Funding 'Fairly Robust'...Or Is It?

The blind men and the elephant are doing their dance again. One of the participants in the latest tango is the New York Times. Others include a venture capitalist and stem cell businessmen.

Here is what the Times carried in a July 25 piece by reporter Jodi Rudoren:

"Even with the limitations on federal financing, the overall financing available for stem cell research could be described as fairly robust, given that the research is still at a basic stage and that in addition to state money, philanthropies like the Howard Hughes Medical Institute have made contributions. Moreover, in the private sector, biotech companies like Geron, Advanced Cell Technology and Athersys conduct research on embryonic or adult stem cells."

No attribution was given for that statement.

A somewhat different view was expressed in California the same day the Times published its piece, according to reporter Steve Johnson of the San Jose Mercury News, who wrote about a hearing held by the California stem cell agency. Here are some excerpts:

"'This is a risky business,' said Martin McGlynn, chief executive officer of StemCells of Palo Alto, which hopes to soon begin testing fetal stem cells to help children with Batten disease, a fatal degenerative ailment.

"That risk also makes it harder for biotech companies to get funding from venture capital firms that are skittish, said Ann Hanham, managing director of Burrill & Company in San Francisco, which finances biotech companies. She said venture capitalists generally prefer to see a return on their investment in five to seven years, which is unrealistic for most stem-cell entrepreneurs.

"Bruce Cohen, chief executive of Cellerant Therapeutics of San Carlos, was one of several executives at the meeting who applauded Proposition 71.

"But given the enormous amount of work that needs to be done to turn stem cells into treatments for such ailments as diabetes and Parkinson's disease, he said, 'even with $3 billion, that's not enough.'

"Cohen urged the stem-cell institute's board to pair its taxpayer financing with money from private companies, adding, 'Prop. 71 can make a huge difference in the world if it's seen as a way to leverage private capital.'"

Of course, there are those who will never be satisfied by any amount of funding. And given the influence that the Times has, its "robust" statement could color the thinking of decision makers nationally about the adequacy of financial support for embryonic stem cell research.

Rebecca Vesely of the Oakland Tribune also covered the CIRM hearing. Here is a link to her story.

San Jose Merc: Full Disclosure Needed from CIRM

The stakes are large and the temptations are great. The evidence also shows that some scientists and physicians cannot resist – perhaps only a tiny handful, but nonetheless a significant number.

What we are talking about is the linkage between corporate interests and medical research. Reporter Paul Jacobs of the San Jose Mercury News is only one of the latest to report the bountiful ties binding the two in his recent look at Stanford University.

The newspaper editorialized on the subject and the California stem cell agency on Monday before today's meeting of its Oversight Committee.

Here is an excerpt:

"California's great stem-cell experiment faces a moment of truth this week.

"Wednesday, in San Francisco, the state's stem-cell institute must make a pivotal decision on whether members of its working groups should be required to publicly disclose any conflicts of interest before they review grant applications and make recommendations to the agency's governing board for final approval.

"The agency should make an investment in public oversight and public confidence and overturn its staff's recommendation opposing full public disclosure.

"The arguments opposing full disclosure have merit. There is concern about whether top-level scientists will be willing to participate in the process if they have to make complete financial disclosures of any potential conflicts. The working groups are strictly voluntary and will require a substantial time investment by out-of-state scientists who must be experts in their field. The disclosure provision could discourage some from participating. So the agency wants to settle for internal disclosure of potential conflicts that could then be reviewed, but not publicly disclosed, by the Legislature or an independent auditor.

"But as Mercury News Staff Writer Paul Jacobs pointed out in a recent series, the relationship between medical companies and premier research universities is growing increasingly cozy, and many professors now have second jobs working for medical firms.

"Public confidence in California's $3 billion investment outweighs the importance of attracting the highest level of scientists to review applications. The scrutiny over who receives the stem-cell research grants is certain to be intense over the course of the next decade. The last thing the state agency needs is a lawsuit or scandal over how it is spending taxpayer dollars. Anything less than full disclosure is bound to invite skepticism about the agency's integrity."

Stem Cell Snippets: Brits, Maryland and Defining the Debate

Links to interesting stories and other items connected to California stem cell issues.

Blair Hobnobs – The visit of Great Britain's PM to California highlighted linkages with the state's stem cell community. Participants in the meetings included Zach Hall, president of CIRM. Brits say they are spending $186 million for stem cell research in the next two years, substantially less than what California is supposed to be doing. It is not clear whether the British funding is for ESC research only or all stem cell research. The stories do not mention that the British consulate in SF has a man assigned to tracking developments at CIRM. You can find the San Francisco Chronicle story here and the San Jose Mercury News story here.

Chirping from Chesapeake – From Maryland comes word that it intends to outstrip California in giving grants for stem cell research, despite having only $15 million to play with. Linda Powers, biotech venture capitalist(Toucan Capital) and chair of the Maryland stem cell commission, stated that goal in a piece in the Washington Business Journal.

Classifying Stem Cell News – What type of news is a report about a stem cell matter – science, medicine, business, politics, governmental? Kaiser Permanente, the mammoth healthcare enterprise, says it is women's health news. That's where they put a summary of stem cell related opinion pieces. Not important, you say. Perhaps to some. But if stem cell research is, for example, considered mainly religious news, a reader might come to a different conclusion than if he or she thought it was a health subject. Defining the debate is still critical to building support for embryonic stem cell research. As for Kaiser's classification, it is entirely appropriate to describe stem cell news as a women's issue, but it is obviously more as well.

Busy Agenda for CIRM Oversight Committee in August

The California stem cell agency will wrestle with everything from intellectual property and open access to research findings to its $150 million bailout and conflicts of interest at meetings of its Oversight Committee Aug. 1-2 in San Francisco.

Background documents are not yet available on CIRM's Web site – only the barebones agendas. We expect to see them filled with links to additional information as the dates of the meetings near.

The public will have a fine opportunity to weigh in on CIRM's strategic plan for giving away $3 billion. A three-hour evening session is set to begin at 7 p.m.

Here are links to the agendas for each day's meeting: Aug. 1, Aug. 2.

Anchors Aweigh for the California Stem Cell Report

As most of you know, this report comes to you from a sailboat in Mexico, which moves about from time to time. When that happens we lose contact with the civilized world and the Internet. So over the next eight days or so, you are not likely to have fresh grist to savor – at least from this Web site. We expect to be back online about the time of the Aug. 2 meeting of the Oversight Committee.

For the sailors among you, the boat is called Hopalong. He/she is a 39-foot Freedom, cat-rigged ketch (1984 vintage) with freestanding, carbon fiber masts. Hopalong is our only home. We have given up the dirt life.

Look for more exciting news and commentary on California stem cell affairs on Aug. or thereabouts.

Ortiz Measure Stripped of Ban on Reimbursement of Lost Wages

Legislation aimed at protecting women who donate eggs for stem cell research has been amended to eliminate a prohibition against reimbursement of lost wages.

The measure, SB1260 by Sen. Deborah Ortiz, D-Sacramento, is now before the Assembly Appropriations Committee. It applies only to stem cell research not funded by the California stem cell agency.

At one point, Ortiz argued that reimbursement of wages should be barred because of the potential inequities involving women in lower paying positions and women in more highly paid occupations.

The bill continues to bar payments to donors except for "direct expenses incurred as a result of the procedure." The measure now appears to conform more closely to regulations approved by the California stem cell agency.

Hank Greely, chairman of the advisory committee on stem cell research with the California Department of Health Services, said the bill will be the starting point for his committee's recommended guidelines for stem cell research, expected later this year.

Greely, a Stanford law professor, said he interpreted the latest language of SB1260 as permitting reimbursement for lost wages although he said it could be argued "the other way."

Our thanks to Greely for pointing out the amendment in the measure.

Stem Cell Snippets: Hear Arnold and Jesse

News, press releases and other information on California stem cell issues.

The stem cell bailout – You can see and hear Gov. Schwarzenegger, California stem cell chairman Robert Klein and vice chair Ed Penhoet announcing the $150 million loan at this location. A transcript is available if you don't want to wade through the video.

Jesse Reynolds of the CGS on the loan – Marc Strassman of California Politics Today has an audio critique of the loan from Jesse Reynolds of the Center for Genetics and Society. No transcript is available.

CIRM Guide to Comments on IP Rules

In a useful and comprehensive document, the California stem cell agency has synthesized comments on its rules for sharing the wealth from inventions that result from CIRM-funded research by nonprofit institutions.

The report organizes and boils down lengthy criticism of the proposed regulations. Included are staff comments and annotations to specific locations in nearly 200 pages of comments and previous transcripts of CIRM hearings. The 10-page document also provides a guide to some of the thinking at CIRM that could well extend to rules for intellectual property involving grants to business.

The summary was prepared for a lightly covered hearing earlier this month during which the IP Task Force adopted some of the recommendations of biotech businesses. Those changes will go before the Oversight Committee on Aug. 2 in a hearing that is likely to refer once again to the analysis of the comments.

The summary is a bit unusual for CIRM. With some exceptions, it has not regularly or consistently produced background documents that organize and attempt to place policy issues in an accessible context. However, increasingly the agency seems to be heading in that direction, a move that well serves both the agency and its constituent publics – academia, business, California and national policymakers as well as the general public.

Bush's 'PR Wonders'

California supporters of embryonic stem cell research like to point to polls that seem to show that most Americans support the effort. This past week was a case study of how that translates into reality. Another take on who won the PR battle can be found on this interesting blog by Matthew C. Nisbet, a communications teacher at Ohio State.

Here is the headline:"ON STEM CELL BILLS, BUSH & CO. WIN THE BATTLE OF THE VISUAL: SC Proponents Worked PR Wonders to Get This Far, But the Power of the Bully Pulpit Is Hard to Beat; Embryo Research is Transformed Visually Into Research on 'Young Humans'"

We say that polls "seem" to show majority support for ESC research because polls can be easily manipulated. Some of these polls are funded by ESC organizations, which are not likely to pay for results that do not support their position. At some point in the future, we will discuss in more detail the reasoning behind our belief that support for ESC is probably weaker than supporters believe.

The $150 Million CIRM Bailout, Politics and Oversight

Call him Arnold the Adroit.

That's Arnold Schwarzenegger, the governor of California, who capitalized on this week's stem cell hoopla by announcing a loan of $150 million to the state's financially troubled stem cell agency. The timing was exquisite politically. It casts the Republican governor in a favorable light in his re-election bid, distancing him significantly from what may be the biggest piece of baggage he has in the race – the Republican president of the United States.

As for the agency itself, the money is undoubtedly a blessing, but one that has a dark side. CIRM Chairman Robert Klein has made much of his agency's independence from the usual ties that state agencies have to the Capitol and politics. This loan gives all in Sacramento an entry point – if they didn't have it already – for dabbling in one fashion or another in CIRM affairs. The loan by the state also provides another avenue for a legal challenge by foes of the agency, which reporter Lee Romney of the Los Angeles Times indicated they are already considering.

That said, it would have been foolish for the agency to have turned down the money on the basis of preserving its independence. But one always has to pay the piper, something CIRM must come to grips with.

Speaking of pipers, state Sen. Deborah Ortiz, D-Sacramento, who is carrying a bill to tighten oversight of CIRM, released a statement on the governor's action that received virtually no attention. It said,

"The governor is honoring the will of the California voters who overwhelmingly approved Proposition 71. Again, California is leading and our president should learn from our state.

"At the same time, the governor’s action underscores the need for stronger public accountability standards for stem cell research in California, as proposed by my Senate Bill 401. These standards will ensure public transparency, eliminate potential conflicts of interest, and ensure that the state receives a fair share on its investment over time, as promised by the initiative.”

CIRM, of course, was delighted by the money, which will allow it to devote its full resources to its prime mission instead of fundraising, which seemed to be the chief occupation of Chairman Robert Klein.

As quoted by Lynda Gledhill in the San Francisco Chronicle, CIRM President Zach Hall said, "With one stroke, the governor has energized stem cell research in California. This is the new frontier in biomedical research, and the United States needs to be working in it. California will become a surrogate for the nation's efforts."

Klein was equally effusive, heaping praise on the governor – praise that is certain to turn up in ads againsts his Democratic opponent, State Treasurer Phil Angelides.

Two of the CIRM watchdogs, the Center for Genetics and Society and the Foundation for Taxpaper and Consumer Rights, were not entirely happy with the governor's move.

The center said:

"Unfortunately, Gov. Schwarzenegger failed to take an important opportunity to implement real, enforceable oversight of the California Institute for Regenerative Medicine (CIRM). Like the majority of Californians and Americans, we support using public money for embryonic stem cell research. But along with public funding should come public oversight. Instead, the governor gave CIRM a blank check.

"Proposition 71, the initiative that created the CIRM in 2004, specifically exempted CIRM from oversight by California’s elected officials. Its governing board is riddled with conflicts of interest, and reports to no one. This lack of accountability is dangerous for the Institute and dangerous for the research."

John M. Simpson of the taxpayer foundation welcomed the funding but said:

"You wouldn't shoot a $150 million movie without a script. Before funding a major scientific project, you need a plan and regulations governing ownership of any discoveries. Otherwise we're truly talking about a blank check for biotech."

The funds are expected to be forthcoming in the next few months and be available for grants in 2007. The mechanism appears to be the bond anticipation notes that CIRM can issue. They will not be repaid if CIRM loses the lawsuit against it. None of the news reports we saw indicated where the governor was going to find $150 million in a supposedly lean state budget. However, the amount is small change in a budget the size of California's -- $131 billion.

A couple of tidbits from the news coverage: Reporter Lisa Krieger of the San Jose Mercury News noted that the governor's pro-stem cell, anti-Bush move came on the same day he attended two fundraisers headlined by the former President Bush. And The People's Daily in China carried an item, contrasting Schwarzennegger's stem cell decision to Bush's veto.

Here are links to other stories on the loan: Terri Somers, San Diego Union Tribune; David P. Hamilton, Wall Street Journal; Laura Kurtzman, The Associated Press; Kevin Yamamura, The Sacramento Bee; Sandy Kleffman, Contra Costa Times.

Hard Data: Stem Cell Researchers Looking to California and Abroad

Hyperbole fills the world of embryonic stem cell research. One shibboleth reiterated with regularity speaks of the "California gold rush." Another has every stem cell researcher in the U.S. booking flights to foreign stem cell sanctuaries.

Now comes some hard data from Princeton University in an article in the July issue of Nature Biotechnology, written by Aaron D. Levine. He surveyed stem cell scientists nationally and verified that some of the rhetoric is reality. Here are some excerpts.

"The data indicate that US stem cell scientists were significantly more likely than biomedical scientists working in less contentious fields to have received job offers to move to new positions in the 12 months preceding the survey. This difference was particularly pronounced for international positions, suggesting US stem cell scientists are disproportionately considering leaving the country. Job offers received by stem cell scientists were skewed toward countries and states with permissive stem cell research policies."

"The survey results indicated that among the subset of respondents who were principal investigators (PIs), mobility, as measured by job offers received, was substantially higher for stem cell scientists than it was for biomedical scientists in other fields. Indeed, stem cell PIs were 1.6 times more likely than PIs in the other biomedical fields to receive at least one job offer, 5.3 times more likely to receive at least one international offer and 7.5 times more likely to receive at least one international and one domestic offer. Members of this latter group, estimated at 12% of stem cell PIs in the US, are presumably weighing the pros and cons of leaving the country to pursue their research."

"In particular, nearly 34% of the job offers reported by stem cell scientists of all levels were for positions in California. In contrast, 11% of the offers reported by the other biomedical researchers were for positions in California."

Levine's article continued:

"Particularly when combined with recent reports suggesting the US is lagging in the production of hES cell publications, these results lend credence to the claim that federal funding restrictions are negatively affecting the field’s development in the United States.These results highlight the importance of public policy in shaping the field of stem cell research and hint at challenges facing policymakers."

"State policy appears to be a potent tool for recruiting scientists, and permissive policies in some states may help the US retain scientists who would otherwise move abroad. However, as the challenges faced by the California Institute for Regenerative Medicine illustrate, state policies pose difficulties of their own. They risk legal challenge and preemption by federal legislation, making stem cell legislation a risky gamble for individual states."

WARF Patent Challenge Coverage: More Likely to Come

The California-based effort to overturn restrictive patents on embryonic stem cell research received a dab of national coverage Wednesday amidst the hoopla about the U.S. Senate vote on Bush's policy.

More coverage on the issue could easily develop. ScienceNow, the online arm of Science magazine, promised a deeper look at the subject on Friday.

The California stem cell agency is maintaining an arms-length relationship to the matter. The agency released a statement from Ed Penhoet, vice chairman of CIRM. Here is the full text, which is not currently available on the Web:

"The CIRM is in the business of providing the necessary funding and infrastructure to help others move the stem cell field forward. There are those who say they are speaking on behalf of California, but they
are not speaking for the CIRM. Currently, we have no opinion on the enforceability or scope of WARF's patents."

Aside from the basics that we reported yesterday, here are some snippets from various stories.

Eli Kintisch of ScienceNow noted that "Harvard pancreatic cell researcher Doug Melton calls WARF's licensing terms 'onerous, restrictive, and uncooperative.'"

Reporter Jim Downing of The Sacramento Bee wrote:

"Negotiating patents and licenses is an everyday part of biotech research and development. But, said Wendy Streitz, policy director for the University of California's office of technology transfer, the way that Wisconsin is choosing to exercise its patent rights is unusual.

"'It's not the cost of the license that's the issue. It's the very fact that we're being asked to take one' -- a requirement that breaks with academic tradition, she said. 'There is the concern that if this became common practice, university technology transfer offices would be spending all of their time issuing licenses to each other.'"

A lengthy story by Sandy Kleffman of the Contra Costa Times appeared in the Kansas City paper, where it has special relevance because of the stem cell ballot measure there.

In Wisconsin, reporter John Fauber of the Milwuakee Journal Sentinel wrote:

"WARF officials declined to be interviewed about the challenge. In a prepared statement, Carl Gulbrandsen, managing director of WARF, said he was confident that its patents were valid. He said the challenge was politically and financially motivated.

"'WARF stem cell patents do not inhibit research,' he said. 'They support and encourage it.'"

The story continued:

"Daniel Ravicher, executive director of the Public Patent Foundation, said the WARF patents have not been challenged before. He said the patent office should decide within three months whether a challenge to the patents is warranted. After that, a decision on the challenge could take 18 months to 10 years."

The issue was also touched on briefly in a piece in the New York Times by Andrew Pollack.

Here are links to the stories by Steve Johnson, San Jose Mercury News, and Lee Romney, Los Angeles Times.

Veto to Hinder California Stem Cell Research

What does the president's veto of the stem cell bill mean for California? Reporter Paul Jacobs of the San Jose Mercury News took a crack at the answer, writing that efforts in the Golden State would be "hindered."

Here is the salient language in his piece:

"...(T)here are ramifications for state-funded research in California -- both direct and indirect.

"The state will still be able to go ahead with plans to spend funds from a state bond measure authorized by Proposition 71 two years ago, but researchers worry that they will continue to waste valuable resources because funding restrictions will force them to create facilities to do work that might have been shared by existing labs.

"Robert Klein, chairman of the committee that is overseeing spending of the state funding, describes Bush's decision as 'tragic.'

"'We could get greater leverage out of our $3 billion if we were able to use federally funded facilities currently in place,' said Klein, who led the effort to pass a stem-cell funding initiative in 2004.

"Said Stanford Nobel laureate Paul Berg, a critic of the administration: 'What many people don't understand is it is not just the money.'' Equipment and laboratory space supported with federal dollars cannot be used for research with the newer stem-cell lines, he said. That's why money directed toward research from California and other states 'is not the whole answer.'

"Dr. Irving Weissman, a stem-cell researcher and director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine, agrees that the federal restrictions have impeded stem-cell work. He noted, for example, that analyzing the genes from new stem-cell lines cannot be done at federally funded facilities on the university campus.

"Another effect is more indirect. Science advances when researchers worldwide are able to pool their data and findings, but researchers in California using state funds who might have collaborated with scientists elsewhere doing federally funded research will not have that luxury.

"Klein said about 50 percent of the nation's biomedical research capacity is in California, and if the other half of the country is hindered, it has an effect everywhere."

Here is Klein's full statement.

The President’s failure today to sign HR 810 is tragic for stem cell science in America and for patients and their families. As a father of a child with juvenile diabetes and the son of a mother suffering from Alzheimer's, I am personally extremely disappointed by the President’s decision to issue his first veto. I am disappointed for every family in California and around the nation with a child, a parent, or any family member suffering from chronic disease and injury. The President’s decision represents a missed opportunity for the U.S. to serve the will of the people and regain leadership in this promising field.

"In order to serve patients, we still need to work together at the state and national levels to move stem cell science forward. In California, stem cell research enjoys broad support of the people and their leaders. Governor Arnold Schwarzenegger personally wrote the President a strong advocacy urging him to sign the bill. In addition, legislative leaders like Speaker Nunez and President Pro Temp Perata, as well as constitutional officers like Lt. Gov. Bustamante, Treasurer Angelides, Controller Westly, Attorney General Lockyer and others are united in support of stem cell research. We are grateful for this broad support

"We all know that the road to stable and adequate funding of this most promising area of science has proved more difficult than we could ever have imagined. Although time is precious, we look forward to the next opportunity to debate—and pass—meaningful stem cell policy at the federal level. But in the interim California moves forward with funding this science. California will continue to lead the nation."

R&D Stem Cell Session in San Francisco Tuesday

Coming up next Tuesday is a promising session with the California stem cell agency on the topic of fostering research and development in California.

It is another chapter in CIRM's effort to come up with a plan to give away $3 billion.

While the subject of WARF and its patents is not specifically listed on the agenda, it seems likely to come up, particularly in the wake of this week's formal challenges of the patents.

The afternoon session in San Francisco includes the following speakers:

E. Edward Baetge, chief scientific officer, Novocell, Inc.; Sumit K. Chanda, group leader, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation; Bruce Cohen, president and chief executive officer, Cellerant Therapeutics; Ann F. Hanham, managing director, Burrill & Company; Martin McGlynn, president and chief executive officer, StemCells, Inc.; Thomas B. Okarma, president and chief executive officer, Geron Corporation; Alan K. Smith, president and chief operating officer, Cognate BioServices, and Michael D. West, chairman of the board, president and chief scientific officer Advanced Cell Technology, Inc.
 

Industry-supported Changes in IP Rules Face August Action

The California stem cell industry has scored a preliminary victory in modifying state rules that it said would hamper private investment in embryonic stem cell research.

The Intellectual Property Task Force for CIRM last week approved the modifications in previously ratified regulations. The recommendation now goes to the CIRM Oversight Committee Aug. 2, where it is likely to receive positive action, although not without continued opposition from watchdog groups.

During consideration earlier this year of IP rules for nonprofit institutions, Oversight Committee members had indicated support for the widest possible dissemination of basic research.

Sandy Kleffman of the Contra Costa Times reported:

"To accomplish that goal, (CIRM) adopted a preliminary policy requiring that companies provide university scientists and others engaged in noncommercial research with access to state-funded inventions and research tools free of charge.

"The goal was to avoid having stem cell researchers subjected to lawsuits from companies complaining they were infringing on a patent.

"But a host of biotech leaders wrote to complain about this policy, arguing that it would cause venture capital firms to balk at getting involved.

"'Under those circumstances, we believe no private funding will be used to license the invention and none of the energy of the commercial market will be made available to enhance, manufacture, advertise, disseminate or support it,' wrote Greg Lucier, chairman and CEO of Invitrogen Corp.

"Task force Chairman Ed Penhoet said he agreed to eliminate the provision, even though he supports it, because many researchers and companies already share such discoveries with others. But the stem cell agency will revisit the issue if a problem develops, he added."

Jim Downing of The Sacramento Bee reported that biotech firms argued that the old rule

"would deprive them of revenue from their primary customers -- other California stem-cell researchers -- and remove the incentive for investment. Joydeep Goswami, vice president of Carlsbad-based Invitrogen Corp., said the rules of the market would keep innovations developed by the private sector at a fair price.

"'It's not in our interest to not make tools available,' he said."

Downing also quoted John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights.

"I'm disappointed that they haven't been able to understand the importance of maintaining a payback to all the Californians who are coming up with this money."

Simpson is likely renew his pitch at the Aug. 2 meeting, perhaps with the support of other organizations.

WARF Patents Under Renewed Assault

As the U.S. Senate wrestled today with embryonic stem cell research, a closely related brouhaha escalated sharply over who owns the rights to "nearly any use" of embryonic stem cells.

Until today, the "rights" debate seemed little more than dueling op-ed pieces. But the Foundation for Taxpayer and Consumer Rights in Santa Monica, Ca., and public service patent attorneys filed challenges to the stem cell patents held by WARF – the Wisconsin Alumni Research Organization.

The move was an extension of the foundation's activities related to the California stem cell agency. John M. Simpson, the foundation's stem cell project director, has been campaigning for months against WARF's position that California should pony up for research involving the patents.

The stem cell agency itself -- CIRM -- has held hearings during which experts have testified to the deleterious impact of the WARF patents on stem cell research.

This morning the discussion moved to the Wall Street Journal. A piece (available at no charge here) by writers Antonio Regalado and David P. Hamilton said,

"...(T)he strict limits imposed by the Bush administration are only part of what's hindering stem-cell research. Another problem: several broad patents held by a University of Wisconsin foundation.

"When executives at Carlsbad, Calif.-based Invitrogen Corp. chose to locate their stem-cell research in Asia recently, they blamed the patents. And today, a California watchdog group, the Foundation for Taxpayer and Consumer Rights of Santa Monica, says it will ask the U.S. Patent and Trademark Office to overturn three patents awarded to James A. Thomson, the Wisconsin researcher who first isolated stem cells from human embryos in 1998."

The writers said the patents "cover nearly any use of human embryonic stem cells."

The WSJ reported this response from WARF:

"WARF officials say they are simply enforcing their legal rights by charging companies to license the patents. 'It's a red herring. People want free access,' says Elizabeth Donley, executive director of the WiCell Research Institute, a center created by WARF in Madison to study and distribute the cells. Ms. Donley says the fees are invested back into research being performed at the university."

Simpson's group issued a press release that said:

"The patent challenges filed today call on the United States Patent and Trademark Office to re-examine and revoke three patents that give the rights to all human embryonic stem cells used for research to the Wisconsin Alumni Research Foundation. The groups estimate that the patents could result in hundreds of millions of dollars of research money being sent overseas each year. Already, the Juvenile Diabetes Research Foundation has funded scientists in other countries and calls the WARF patents a “major inhibition to productive scientific research.”

"'It is absolutely absurd that one person or organization could own the rights to life itself. But that is exactly what has happened because of these over-reaching patents,' said John Simpson, Stem Cell Project Director for FTCR. 'The real debate in stem cell research is not about the science, but whether American scientists will be allowed to participate in the global laboratory.'"

The press release continued:

"'WARF has been allowed to profit at the expense of public health while many American scientists have been barred from conducting life-saving medical research. These over-reaching patents threaten our health, waste taxpayer money, and send valuable research overseas," said Dan Ravicher, Executive Director of (the Public Patent Foundation). 'We’re calling on the United States Patent Office to revoke these overreaching patents.'

"The groups said the patents' dubious validity is underscored by the fact that no other country in the world honors them. As a result, U.S. researchers have sent research monies abroad where they can avoid paying royalties to WARF."

Also participating in the patent challenge was Jeanne Loring of the Burnham Institute, who has long argued against WARF's position.

She said,

"'These patents should have never been issued in the first place. The real invention was made 25 years ago, when embryonic stem cells were first discovered – and the scientists who discovered them didn't expect a payoff. James Thomson just followed a recipe written by other scientists, and there's nothing patentable about that."

You can find Loring's declarations on the foundation's web site via the press release along with the official texts of the challenges.

CIRM Spawns 'New Life' -- Partly

The Journal of Neuroscience has published a piece that says U.S. stem cell research has "taken on new life, driven in part by the California experiment."

Written by Arlene Chiu, director of scientific program and review for CIRM, and Zach Hall, president of CIRM, the brief article is a straightforward account of CIRM's short life. Most of the history is quite familiar to readers of this blog.

But the pair did note an often overlooked fact that the agency has approved "the most comprehensive set of regulations on stem cell research in the country." While Chiu and Hall avoided touting the regulations, it is fair to say they are the benchmark for ESC research rules in the United States.

Chiu and Hall also wrote,

"Despite the lack of funding, Prop. 71 has provided an important stimulus for stem cell research in California and other states. In California, universities and other research institutions have hired new faculty, raised private capital and planned new buildings for stem cell research so that they will be read to compete for public funds once they are available. Faced with competition from California, other states have committed funds, and, in some cases, private foundations have been started to support local stem cell research. As new efforts are mounted in various states across the country, it will be important to ensure mechanisms for collaboration and for transparency, so that new stem cell lines that are derived can be widely shared."

Speaking of sharing, the article is not available online except to subscribers of the Neuroscience Journal. But you might be able to get a peek at if you make a request via the agency.

The article was printed in the June 21 edition of the journal, whose cover consisted of an interesting illustration/outline of California as a cluster of globules. The graphic was executed by Gil Sambrano, scientific review officer for CIRM.

WSJ Highlights Research Conflicts of Interest

Talk about prescience. Two days after reporter Paul Jacobs published his piece about the web of financial ties between Stanford medical researchers and the medical business, the Wall Street Journal pops up with a first rate example of the nexus of money and medicine.

In Tuesday's WSJ, reporter David Armstrong discussed a study in the February issue of the Journal of American Medical Association that said stopping antidepressant medication during pregnancy greatly increases the risk of relapsing into depression. Good news, Armstrong said, for makers of antidepressants who are facing questions about the safety of their products.

"But the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants. The lead author -- Lee S. Cohen, a Harvard Medical School professor and director of the perinatal and reproductive psychiatry research program at Massachusetts General Hospital -- is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers. None of his financial ties were reported in the study. In total, the authors failed to disclose more than 60 different financial relationships with drug companies," Armstrong wrote.

The California stem cell agency is resisting legislative efforts to require more disclosure about potential conflicts of interests involving its work. The Wall Street Journal story is another good example of why CIRM needs to open its doors more widely. Sunshine is the best prevention of misdeeds in public life.

Stanford's Rationale for Release of Conflict Info

Stanford University's decision to release information on the relationships between researchers and the corporate world is not one that all in academia would agree with. Nonetheless, it was a healthy response that undoubtedly staved off dribs and drabs of stories that would have reflected poorly on the school.

The San Jose Mercury News piece on the subject (see item below) did not discuss Stanford's reasoning behind the release of the information. We asked Paul Costello, executive director of the Office of Communication and Public Affairs at the Stanford School of Medicine, for comment on the decision to go public. Here is his response verbatim:

"The conflict-of-interest issue is an important topic that merits discussion and debate. Clearly from the highest levels at Stanford -- President Hennessy to Dean Pizzo -- transparency is viewed as essential if we are to help inform the public about the benefits of the biomedical community's involvement with industry.

"Much of the interaction between universities and industry is driven by the 1980 Bayh-Dole Act, which was enacted with the goal of speeding up the commercialization of federally funded university research and helping new industries develop more quickly.

"The Council on Government Relations estimates that there are now more than 1,000 products on the market based on university-licensed discoveries, including many that are used in diagnosing and treating diseases. Yet we also recognize that collaboration between university researchers and private companies carries the potential for conflicts of interest. Stanford has been, and will continue to be, vigilant in monitoring these interactions to ensure that the integrity of our scientists and of their research is not compromised.

"When we were contacted by the Mercury News reporter about the conflict-of-interest topic, we wanted to work with him so that this important story could be told as accurately as possible, and to demonstrate Stanford's considerable efforts to conduct its industry interactions with integrity."

Stanford University: Medical Research, Money and Conflicts of Interest

In a news story that has major implications for the California stem cell agency, the San Jose Mercury News has detailed a web of relationships that have enriched Stanford University and "fattened the personal bank accounts of many of its prestigious faculty members."

The article by reporter Paul Jacobs is a rare look inside the normally private Stanford documents designed to monitor the ties between faculty and medical companies.

The story said:

"Dozens of professors moonlight for medical firms or have founded companies based on their government-funded research.

"In the 2004-05 academic year alone, $38 million in royalties poured into the university from medical school discoveries -- roughly $10 million of which went directly to faculty researchers whose discoveries were patented.

"Critics worry that these complex financial and ethical relationships between companies and the nation's premier research universities are corrupting science and producing overly enthusiastic portraits of new treatments."

Friends and foes of the California stem cell agency have longed expressed reservations concerning the built-in and legal conflicts of interest that riddle CIRM. A measure –opposed by CIRM -- is now before the legislature to tighten oversight and force more disclosure of potential conflicts of interest.

Jacobs' thorough and even-handed story, based on six months of work, said:

"Financial conflicts can turn campus laboratories funded by taxpayer money into outposts of corporate research. They can divert researchers from work that might have a bigger impact on health toward research with bigger financial rewards. And in the worst cases, they can blind scientists to the dangers of treatments they are studying, resulting in injury or even death among volunteers."

The story noted that links between medical research and the corporate world exist at virtually every major unversity in the country.

Stanford voluntarily disclosed to the San Jose newspaper overall figures for a single year concerning its faculty's relationships. The article did not explain the university's reasoning behind the disclosure, but it was a bold decision – one that reflects well on the school but one probably opposed by significant segments within the university. The action was fundamentally good public relations. The choice is to release more information, as the school did, or suffer mightily as bits and pieces dribble out, each one making Stanford look worse and worse.

Philip Pizzo, dean of the medical school and a member of the Oversight Committee for the California stem cell agency, told Jacobs that conflicts are unavoidable but manageable. He said Stanford's "standards for dealing with conflicts are 'the most rigorous' in the country."

But, Jacobs reported, Pizzo "also says ties to industry are necessary if the university is to translate its research into practical treatments for patients."

Not everyone agrees with Pizzo on the "manageability" of conflicts. Jacobs wrote:

"'There is a focus on procedural solutions and this magical belief that disclosure is the answer as opposed to dealing with the fact that many of these things should not be allowed,' said Barbara A. Koenig, a bioethics researcher at the Mayo Clinic and former executive director of Stanford's Center for Biomedical Ethics.

"Tufts University Professor Sheldon Krimsky, author of 'Science in the Private Interest,' argues that fields such as law have stricter conflict policies than universities. A judge, for instance, isn't allowed to have any financial relationship with a party that might benefit from a ruling."

Jacobs' article also included the following segment on one of the brighter stars in stem cell research.

"...(N)o one is more up-front about his financial conflicts than Dr. Irving L. Weissman, one of the founding fathers of stem-cell biology. His lab at Stanford was the first to isolate blood-forming stem cells from animal bone marrow. Today, in addition to his own lab, he directs Stanford's Institute for Cancer/Stem Cell Biology and Medicine.

"Weissman's research has made him a multimillionaire entrepreneur.

"When he gives speeches, when he publishes papers, when he testifies before Congress, he lets everybody know what his outside financial interests are.
"After serving on the scientific advisory boards of Amgen and DNAX, he helped launch three companies, all based on his stem-cell expertise and, in varying degrees, on the research done in his medical school laboratory.

"Weissman recently recalled what led him to form the first of his companies, SyStemix.

"He describes a frustrating year trying to get the facilities he would need on campus to advance his work. He finally concluded in late 1988 that he would have to start a company. He went to (Donald) Kennedy, Stanford's president at the time.

"A biologist who is now editor in chief of Science magazine, Kennedy had reservations. 'I didn't want faculty wandering from their homes on campus into labs thinking about money in their next offshore venture,' he recalled.

"But Weissman convinced him that he could separate his work at the company from his work in the lab. A faculty committee would look at his NIH grants every year to see, Weissman said, 'if I was starting to slant my grants in favor of topics relevant to the company.' He and Kennedy agreed Stanford would not take shares in the company, avoiding a financial conflict for the university -- a policy later abandoned.

"Today, Weissman sits on the boards of directors and scientific advisory boards of two other companies he co-founded -- StemCells Inc. and Cellerant Therapeutics. His method of handling his conflicts, primarily through disclosure, has become the standard at Stanford and other medical schools.

"'The way I usually do it is, I say, `I have stock and I'm a director of this or that, so you might think I'm biased. I don't think I'm biased, but there could be unconscious bias, so you judge,' he said.

"'You ought to be able to do whatever experiment along this line with transparency so everybody knows at every step of the way what your involvements are, what your bias might be, so you can move it forward,' he said, referring to scientific progress. 'But I think it's morally reprehensible not to move it forward.'"

California AG Moving Against CIRM Foes

California Attorney General Bill Lockyer is expected today to attempt to kill off the latest effort to halt work by the California stem cell agency.

The likely action was reported by the California Politics Today web site. Basically the attorney general's reasoning is that the effort to halt funding of grants to the University of California has already been decided in Alameda County Superior Court.

The latest anti-CIRM effort has received virtually no attention in media. Marc Strassman, who runs the California Politics Today site, has been alone on the story, as far as we can tell. His site includes audio interviews with some of the principals.

Stem Cell Research and Bringing Camels into the Tent

"You’re at a point where you can change the world." -- Michael Amos of the Advanced Technology Program at the National Institute of Standards and Technology.

Just one of the comments emerging from the search by the California stem cell agency for a plan on how to give away $3 billion.

Amos' comment was contained in a freshly posted document on the CIRM's Strategic Planning Web site. The 31-page report is a concise summary of the May 25 scientific conference and is filled with provocative and wide-ranging ideas, including reflections on the political impact of research that produces negative results.

A presentation, however, by Jonathan Shestack, a CIRM Oversight Committee member and co-founder of Cure Autism Now, caught our eye. He discussed the importance of sharing and how his organization was surprised by the lack of communication in the autism field. He also discussed the need to become an informational resource that benefits all research in a particular field.

Here are some excerpts from Shestack's comments as summarized by CIRM:

"The most important thing anyone said to us was that we had to 'become the data.' At that point we couldn't rely on people sharing data or raw materials. It was sort of an education to us that people didn't routinely share data."

"We realized we couldn’t rely on making people share so we had to become the central resource and that's what we did, and it's been the best return on investment."

"We were really sort of bootstrapping the field, but we have to guard against becoming institutional and what we hate the most. And that's the biggest danger CIRM has."

"Nothing good ever came to CAN (Shestack's group) without us giving things away. The more CAN gave things away and didn't worry about ownership or getting credit or getting cited, the better it was for us, not as an institution, but to the field. I have this deep feeling that the more you give it away the better it will be."

"What is true and does pertain to CIRM is how to bring many people together. We have complicated problems with different issues and it's a constant struggle to keep people in the tent. We started with the assumption that we would never be able to close the flaps of the tent and say we've everything. We're constantly trying to bring more and more people into the tent."

CIRM President Zach Hall spoke to the issue of what some might call managing expectations.

"Someone today said if you don’t have lot of failures you not being adventurous enough. I have commented on the gap between the political and scientific cultures in California. People have to understand that not all science succeeds. If you are too successful you're not adventurous enough on setting those goals. That's a balance we'll have to strike. It is an education matter in the end. It is also a policy matter and we'll discuss at a later session how to balance innovation and results and how to get the singles and not just the home runs to push things forward."

It is hard to overemphasize Hall's point. The public and advocacy groups want and are conditioned to expect instant solutions and cures. Indeed, American society is oriented in that direction. Without laying the groundwork as soon as possible and educating the public, CIRM could become ensnared in a few years in an unpleasant trap when critics begin to demand: "Show us the beef." At the same time, CIRM must demonstrate that is fulfilling the promise of Prop. 71. Juggling those two goals is a difficult task but one that CIRM must master.

UC Irvine Looking for CIRM Grant

Leverage is everything. That is one $10 million lesson that a bond fund manager is delivering to the California stem cell agency.

Bill Gross, founder of PIMCO, agreed to donate that much to UC Irvine for its stem cell research program. Two million will go immediately for staff and equipment. But the remaining $8 million is conditioned on matching funds.

A UCI spokesman says the school is looking for a grant from CIRM to achieve that goal.

Here are links to stories on the grant: Los Angeles Times, The Associated Press, Orange County Register. Here is the press release from UC Irvine.

WARF Smacks Stem Cell Watchdog

WARF says California is trying overtake Wisconsin as the national leader in stem cell research by using its patents unfairly and illegally.

The organization took that position in an op-ed piece in the Wisconsin State Journal last week. It was written by Carl Gulbrandsen, managing director, and Elizabeth Donley, general counsel.

They wrote:

"In a guest column on (June 26)Monday, John (M.) Simpson of the California-based Foundation for Taxpayer and Consumer Rights argued that the Wisconsin Alumni Research Foundation is impeding life-saving research.

"Nothing could be further from the truth."

Among the evidence they cited for their position was an analysis of ESC research articles published worldwide between 2002 and 2005 that showed that 67 percent of those articles cited Wisconsin's stem cell lines. What that also shows is dominant market share – not as strong as Microsoft's but very strong. (Now there's an interesting question: How is WARF like Microsoft?)

They continued:

"In short, California wants to benefit from stem-cell science by using patents and licenses created using Wisconsin's patent rights to overtake Wisconsin as the national leader in stem-cell research. That is an understandable goal. California also want to do so without recognizing the contributions of Wisconsin's scientists, which may be understandable, but is not fair or legal."

Simpson authored another op-ed piece in The Sacramento Bee, which is nearly identical to his earlier piece in Wisconsin. However, it carried this additional paragraph.

"Earlier this spring, Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation, told a CIRM committee meeting that the patents are 'a major inhibition to productive scientific research.' Because of WARF's claims, Goldstein said, his foundation has funded scientists in other countries 'to create new and better stem cell lines, and that process … is currently flourishing.' U.S. companies interested in conducting stem cell research report they have had difficulty getting funding because of the WARF patent demands."

The Bee has a feature that allows its readers to comment online on op-ed pieces. Concerning Simpson's piece, one said,

"I hereby patent humanity! Anyone being born after today must send me 1 dollar, including any judges."

Obviously nobody should steal another's property, but in this case WARF may have difficulty in communicating its message to the public.

Upcoming CIRM Events

Monday July 10 -- Meeting of the Strategic Planning Advisory Committee in San Francisco at CIRM headquarters. A progress report is planned as well as discussion of technologies for stem cell research. Plans for the July 13 scientific conference and the July 25 commercial sector meeting are also on the agenda. No remote access is available.


Thursday July 13 – "The Scientific Challenge: From Basic Science to Clinic," daylong strategic planning conference in San Francisco. Five speakers scheduled on the agenda. No remote access is available.


Friday July 14 -- Intellectual Property Task Force meeting in Sacramento. Only one topic is on the agenda: consideration of public comments on the IP policy for nonprofits. That policy was approved last February by the Oversight Committee but is now going through the formal state adoption process. Remote access to the meeting is available at UC Irvine.

Stem Cell Legal: Fishing for Another Judgment

The folks who have failed in their legal attempts to exterminate the California stem cell agency are trying another tack.

This time they want to halt funding of CIRM grants to the University of California on the grounds that such funding amounts to an illegal conflict of interest because nine members of the 29-member body approving the grants had ties to UC.

The action in Sacramento County Superior Court is just a retread of the CIRM foes' earlier attempt in Alameda County Superior Court, a move that was rejected by a judge in a very brief trial and is now on appeal.

While providing lip service to legal arguments, the CIRM foes have made it clear that their primary motivation for their action is their religious opposition to embryonic stem cell research. They have also made it clear that if they cannot prevail legally, the next best thing is to force the agency and now the University of California and the state Controller to waste time and money on frivolous lawsuits.

We would have more tolerance for their legal positions if we had not witnessed their performance in last February's trial. They were unprepared and appeared to have failed to do basic research that could have bolstered their position.

We should note that litigation in America serves a variety of purposes aside from settling legal disputes. One is to stimulate media and public attention. Another is to stimulate the constituencies of the organizations involved in the legal action. Those are important objectives for the CIRM foes.

The Web site California Politics Today, run by Marc Strassman, was the first to report the latest lawsuit. Here are links to his two stories on the subject (the first one and the follow the next day). Here is a link to the legal filing.

Other than Strassman's piece, we have not seen any other coverage of the latest lawsuit.

Business To CIRM: We Need More Money

The California stem cell agency's plans for sharing the swag from research by nonprofits is drawing fire from the for-profit sector.

The national Biotech Industry Organization has complained in a letter to CIRM

:"These provisions substantially reduce or eliminate the incentives to commercialize patented stem cell-related technologies and products even in spite of the generous funding provided by Proposition 71."

Reporter Steve Johnson of the San Jose Mercury News reported the complaints from private sector, which were obtained from CIRM after the Mercury News filed a request under the public records act. Also registering complaints were the California Healthcare Institute, a biomedical industry group, and several biotech firms including Applied Biosystems of Foster City, Ca.

On the other hand, the California Council of Churches complained that the nonprofits would receive too great of a share of income from inventions from state-financed research.

Johnson's story also makes it clear once again that CIRM's initial approval of regulations is far from the final action. After the Oversight Committee approves them, they must go through the official state administrative proceedings allowing for additional comments and changes. That is the current stage for the nonprofit research rules, which were approved by the Oversight Committee last February.

Stanford Bioethicist Says More Monitoring Needed on California Stem Cell Research

Stanford bioethicist David Magnus says that the research rules of the California stem cell agency "lack adequate monitoring mechanisms."

His views were reported briefly in a recent piece in the Technology Review by writer Emily Singer in an article entitled "Lack of Human Eggs Could Hamper US Cloning Efforts."

Singer wrote:

"Unlike other types of human research, there are no U.S. federal guidelines governing how these experiments should be carried out. President Bush severely limited federal funding for embryonic stem cell research in 2001, including all research involving the creation of new stem cell lines. This has meant that the National Institutes of Health, the nation's largest source of biomedical funding, has not played its normal regulatory role, and individual states and research institutions have had to pick up the slack. "If there were agreed-upon national standards, it would probably speed up much of this protocol approval process," says Arnold Kriegstein, director of UCSF's stem cell program.

"Both Massachusetts and California, the latter via the California Institute of Regenerative Medicine, have recently enacted rules governing embryonic stem cell research. Both sets of guidelines prohibit paying egg donors, but do allow compensation for direct expenses, such as childcare and transportation. California takes it one step further, allowing women to be paid for time off work. It's unclear if Massachusetts law permits this practice.

"David Magnus, a bioethicist at Stanford University, says these regulatory systems lack adequate monitoring mechanisms, though. 'I think it would be an advantage to think about ways to make sure researchers are doing what they say they are going to do,' says Magnus. 'I would guess that we won't see problem with the first few institutions, which have been very careful. Problems would more likely occur down the road, when [nuclear transfer research] starts to become routine.'"

We asked Magnus for further comment on his statement. He responded:

"I made a general point and said that the CIRM rules are similar to most of our research participant protection system, which focuses on informed consent documents, protocols, etc. and very little on monitoring. We could, for example, do quality control activities that other industries have, such as taping some informed consent sessions to determine if that actual consent process does what it is supposed to do (the studies of this sort that have been done have found some problems that could be eliminated). We could also build in studies of the informed consent process into a lot of the research that gets conducted. At this point the CIRM guidelines are actually completely silent on issues that will arise in clinical trials."

Magnus also has more to say about informed consent procedures in the transcript of the June meeting of the ESC advisory committee for the California Department of Health. The group is formulating rules for ESC research in California that is not funded by CIRM.

Magnus cited informed consent procedures involving gene transfer research. He said,

"If you think of gene transfer research as a comparable, cutting-edge research, that’s a good analog to what we are talking about. There’s a lot of empirical studies about how that’s done, and the IRB’s are clearly not doing a good job. Because if you look at informed consent forms that went through IRBs, they’re full of misleading language.....There are maybe two or three studies published in the past year or two about informed consent forms and how awful they are. And that does not even count how - what actually happened in the actual consent process verbally where there’s not as much data, but what has been collected was terrible."

.

Protection of Egg Donors Heading for Governor's Desk

Legislation aimed at protecting women who donate eggs for stem cell research in California – except for research financed by CIRM – cleared a state legislative committee and appears headed for the governor's desk.

The measure – SB1260 by Sen. Deborah Ortiz, D-Sacramento – was approved on a 12-0 vote earlier this week. It now goes to the Assembly Appropriations Committee, where it is likely to be sent on to the Assembly floor.

Ortiz' office issued the following statement:

"'Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans,' Ortiz said. 'We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.'

"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of potential risks and provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production (AOP) procedures. The bill limits, in accordance with the National Academy of Sciences, compensation to only allow reimbursement for direct expenses. It also provides payment for expenses associated with any necessary pre and post-procedure medical care.

"The bill will provide a streamlined set of standards for egg donations and continue state oversight that began in 2003 with SB 322 by Ortiz. Under SB 1260, an advisory committee created by SB 322 will finish making recommendations to the Department of Health Services (DHS) so that DHS may develop stem cell research guidelines for reviewing stem cell research projects."

The Health Services advisory committee has said it "is concerned with the designation of the IRBs (institutional review boards)as regulatory bodies of stem cell research, the breadth of the requirement for provision of medical care for adverse medical consequences of donating oocytes for research purposes, and the broad and ambiguous restrictions on who may be a research oocyte donor," according to the latest legislative analysis of the bill.

China No. 1 on ESC Spending, except for California?

Earlier this spring, some members of the California stem cell agency's task force on intellectual property wondered about the size of funding worldwide for embryonic stem cell research, excluding the United States.

The answer seems to be something in the neighborhood of $600 million annually, but that figure could well be low. The total is derived from a report on the CIRM Strategic Planning Site, which reviewed research activities in a number of countries. The report seems to confirm the conventional wisdom that CIRM, at $300 million-plus a year, would be the world's single largest source of funding for embryonic stem cell research.

The CIRM document is called "Overview on the Current State of the Development of New Human Embryonic Stem Cell Lines." The document is heavily qualified and "is not intended to be comprehensive or exhaustive." For example, some of the funding reported is current only as of 2004. And it is not entirely clear whether some of the numbers include funding for non-embryonic stem cell research.

Squishy as the numbers may be, they do provide a window on the size of programs in various countries. The CIRM staff report did not attempt to come up with a total or a ranking, a task attempted by the California Stem Cell Report. Our results are filled with caveats to numerous to mention.

China appears to have the largest annual program with a total as high as $249 million with the United Kingdom following at about $193 million, although it is not clear that all of the UK funding is available. Likewise, China's spending may be less.

Australia comes in at about $47 million, Singapore at $25 million, Korea at $18 million, Canada at $17 million, Israel at $7 million, Sweden at $2.2 million and India at $1.9 million. You may think some of these numbers seem strange. So do we, for a variety of reasons.

For example, Singapore has created a $600 million fund to invest in cutting-edge life science projects, including stem cells. But it is not clear from the document whether any of that money is included in the $25 million total for stem cell research expenditures.

Singapore is also involved with Australia in an endeavor called ES Cell International Pte Ltd. (ESI). It is not clear how the funding for that group is split between the two countries.

Other examples could be cited. But this is a rough cut. Many other interesting bits of grist can be found in the document.

Correction

In a June 20 item, we incorrectly described the Wisconsin State Journal as the Madison State Journal.

Is WARF Patenting Chickens?

Advice to Wisconsin from a Santa Monica group: Get the dollar signs out of your eyes.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, wrote an op-ed piece in the Wisconsin State Journal concerning the state's stem cell patents. In it he chastizes the Wisconsin Alumni Research Association.

He wrote:

"Patenting embryonic stem cells because you have a method to isolate them is like patenting chickens because you have a new method to provide chickenfeed. Or, like patenting food because you can cook. Nonetheless, WARF claims and has, at least for now, been granted the rights to all human embryonic stem cells in the United States. The patents' dubious validity is underscored by the fact that no other country in the world recognizes these claims."

Correction on CIRM Firing Policy

David Serrano-Sewell, CIRM Oversight Committee member, corrected us on the "Two-Boss Brew" item June 20.

Here is what Serrano-Sewell said,

"The ICOC approved (13-5 vote) the 'internal goverance policy.' As you note, the amended policy granted to the Chair the authority to concur with the hiring of certain CIRM staff, Senior Officers. The proposed policy was amended to limit the Chair's concurrence authority to two Senior Officers in legal and communications. Please note, the adopted policy does not grant to the Chair the authority to fire or concur in the firing of those Senior Officers.

"Arguably, the policy is confusing. The President could hire a Senior Officer with the Chair's concurrence and then fire that same Senior Officer without the (Chair's) concurrence."

We thank Serrano-Sewell for the heads up. We appreciate all such messages and try to correct mistakes promptly.

"Good" Audit, Poor Cooperation at CIRM

Should an auditor hired by a state agency refuse to provide copies of information about that agency to the one of the key fiscal watchdogs for the state of California?

One would think not. After all, aren't all state agencies supposed to be working together?

That situation involved the California stem cell agency and the auditing firm, Gilbert Associates, that it hired to conduct an audit as required by law. The state Controller's office is the agency that attempted to secure copies of the information. But Gilbert refused to provide the copies, arguing that the information was proprietary. Based on statements from CIRM and the controller's office, the situation has been cleared up.

But it does not augur well for CIRM's responsiveness to continuing concerns about its openness and transparency.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., said,

"CIRM would have us believe that the audit demonstrates the institute operates within the common practices of state agencies. Other state agencies don't hire auditors who stiff the controller's office when it's operating on behalf of the people of California."

"The bottom line is simple. CIRM is a state agency; they must act like one. I guess CIRM management needs to engrave that motto on their foreheads."

We should not have to remind readers that audits vary widely. And some auditors feel unwilling to bring bad news to the enterprises that hire them. The headlines were full of news a few years ago about collapsing companies with beautiful audit findings.

Here is a link to the San Francisco Chronicle story by Carl Hall on the audit findings. Here is the CIRM press release, the controller's report and the audit itself, which covers only the 2004-2005 fiscal year.

Black Leaves Oversight Committee

Gov. Schwarzenegger has the opportunity to make another appointment to the Oversight Committee of the California stem cell agency with the departure of Keith Black, director of neurosurgery at the Cedars-Sinai Medical Center in Los Angeles.

Black resigned quietly earlier this year. No announcement was made of his departure.

A spokeswoman for the agency said Black resigned because of "time constraints."

Looking Inside CIRM's Planning

Embedded in the California stem cell agency site are significant documents that provide insight and information dealing with how the agency will give away $3 billion.

For example, one summary from a May 25 meeting discusses funding mechanisms involving business and nonprofits as well as whether new embryonic stem cell lines should be the focus of early funding.

The document is intended to be comprehensive concerning discussion at the meeting but does not imply any commitment by CIRM. However, if you are interested in where the $3 billion will go or want some of it, you should watch the strategic planning process carefully. And make your voice heard as well. The agency is moving rapidly.

Here is a sample of interesting themes emerging from the May planning conference on funding structures:

Partnering with other agencies, much as does the Juvenile Diabetes Research Foundation, to extend the reach and impact of funding.

Emphasizing early phase discovery research with a strong focus on "world-class science."

Shaping the nature of grant applications prior to receiving them as do other funding organizations.

And there was this interesting caveat:

"CIRM must be aware that it will be difficult to put out large numbers of grants without potentially exhausting their review committee. For example, JDRF funds about $120M in research per year to about 500 investigators, has about 15 different types of grants, and used 150 scientific reviewers last year. That is far more reviewers than CIRM has."

At another point, the question of renewed federal support for ESC emerged, although questions were raised about the impact.

"Given the flat state of NIH funding, funding will still be tight even if the bill passes. It is not necessarily innovative to derive new ESC lines so funding may be difficult to come by," the document said.

The item below outlines several other documents as well. In the coming months, we will continue to alert you to planning documents as they are posted on the CIRM Web site.

CIRM's Strategic Plan: A Guide (v1.0) to Planning Documents

Here are links to interesting and fresh documents related to strategic planning by the California stem cell agency. During the months ahead, we will continue this regular alert to significant planning documents as they are posted on the Web.

Cord blood -- "Overview of Current Umbilical Cord Blood Banking, Clinical, and Research Activities" – Document reports a suggestion that a "donor-sibling cord blood banking service" be created for California families and that NIH cord blood funding has declined from $21 million in 2002 to $18.6 million in 2006.

ESC Databanks -- "Overview of Current ESC Databanks" – Covers many efforts worldwide. Topics for CIRM include whether there is "a need for CIRM to provide an information resource on human embryonic stem cell lines" and whether CIRM should "create its own ESC characterization database using a best practices approach."

CIRM mission statement proposals – This 18-page document includes proposals presented to the Oversight Committee as well as ones suggested by committee members. Sample from one committee member: "Set the highest standards for scientific integrity, openness, collaboration and technology transfer."

Previous postings on the California Stem Cell Report related to CIRM planning include: questions being asked, Interviewees and their answers, Hall's discussion questions, planning Web page , report from last fall's scientific conference, formal kickoff/overview , clashing interests.

CIRM Strategic Planning: The Questions Being Asked

Here are the questions that are being asked by CIRM as it interviews scores of persons around the country during its planning process. We are posting it verbatim because it does not seem to be available on the CIRM Web site.

The text follows:

Thank you again for your willingness to participate in our interview process for the CIRM scientific strategic planning initiative. We are asking all interviewees to answer questions 1 through 3, as well as 13, but would greatly appreciate your input on the remaining questions on which you would like to comment.

This template is intended for your use only; there is no need to return it to us.

1.In ten years, what will success for the Institute look like?

2.What specific objectives should the Institute pursue in order to realize that vision of success? What are concrete measures of progress along the way to those objectives?

3.What are the most pressing needs that the Institute must address immediately to achieve its goals?

4.Is there "low hanging fruit", that is, opportunities for quick, visible, low-risk successes?

5.What is the best way to foster stem cell research that achieves treatments and diagnostics? Should we target specific diseases for funding or sponsor more broadly based initiatives within which a variety of diseases can be accommodated? If we decide to fund specific diseases, how do we decide how and when to fund to fund that research?

6.Are there specific funding structures (particularly novel ones) that will best help us achieve our objectives?

7.How do we balance funding for targeted research versus funding for discovery?

8.How far along the basic / translational / clinical research continuum should the CIRM aspire to move?

9.When and how should we involve the private sector?

10.How will we know when and how to advance findings into the clinic?

11.How can we encourage collaboration particularly between basic and clinical scientists to advance the science into the clinic?

12.CIRM is allowed to spend up to 10% of its allocated funding for facilities. How important do you consider this as a focus for spending? How can this money best be used?

13.Is there anything else you would like to add or any questions you would like us to address going forward?