Thursday, May 31, 2007

The Canadian-California Stem Cell Treaty

California Gov. Arnold Schwarzenegger did not exactly blow the dome off the Capitol -- newswise -- with his stem cell announcement in Canada yesterday.

Coverage was minimal. Perhaps the most details can be found on the governor's web site. California stem cell Chairman Robert Klein, who traveled to Canada as part of the governor's party, is also featured there with a video blog on stem cell matters.

Some excerpts from the governor's statement:
"(Ontario Premier)Premier McGuinty announced the formation of a new Cancer Stem Cell Consortium that will bring together the best minds and resources in California and Canada to fight cancer through stem cell research.

"This project was initiated by the stem cell and regenerative medicine working group of the Canada-California Strategic Innovation Partnership, a unique collaboration between California and Canada stakeholders from academia, the private sector and government."
"The Ontario Institute of Cancer Research will donate the first $30 million (Canadian) to fund the Consortium, benefiting both Canadian and Californian researchers."
"UC Berkeley's Stem Cell Center and Canada's International Regulome Consortium will coordinate research and take advantage of each institution's expertise."
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The CIRM Budget and Burger King

The California stem cell agency plans to nearly double its staff during the next 12 months or so.

That means it will grow from tiny to not-so-tiny. In other words, from 24 workers to 41.

The additions are much needed. Beleaguered might be too strong a term to apply to the staff, but it probably was appropriate on some days during the last two years.

The additions are part of the budget approved earlier this week by CIRM's Governance Committee. The spending plan totals about $8 million for administrative functions, up from about $7.3 million for the current fiscal year, which ends June 30. The full Oversight Committee is expected to approve the proposal next week in Los Angeles.

CIRM is already seeking applications for the following positions: president, associate legal counsel, grants management officer, grants management specialist, grants technical assistant and scientific program and scientific review officers.

The agency will also see a substantial decrease in costs related to the now finally finished litigation, but CIRM will add $200,000 for legal work related to intellectual property issues.

Lest you fear that CIRM is on a path of rampant bureaucratic growth, Prop. 71 capped the number of employees at 50 to administer the $3 billion research effort. We would have to check, but it is probably fewer than it takes to run a Burger King. Sphere: Related Content

Wednesday, May 30, 2007

CIRM Legislation: A Cash Cow or Bum Steer?

Legislation to ensure that California garners a decent return on its $6 billion investment in embryonic stem cell research has hit a roadblock and faces a critical hearing on Thursday.

The measure is SB771 by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley. Kuehl is chair of the Senate Health Committee and Runner is the No. 2 GOP leader in the Senate.

The bill has been shunted into a "suspense" file, along with many others, because the chair of the Senate Appropriations Committee, Tom Torlakson, D-Concord, is uncertain whether the measure would generate more revenue than would the regulations of the California stem cell agency itself.

If the measure is not removed from the suspense file, it will be placed on hold for this year and is not likely to be brought up again until January.

Discussions have been underway between Kuehl, Torlakson, Senate President Pro Tem Don Perata, D-Oakland , and Senate Majority Leader Gloria Romero, D- Los Angeles, about the fate of the bill. Kuehl and Runner are contending that it is impossible to make revenue comparisons between the bill and CIRM regulations because the regulations are not in final form. They also argue that arguments by the biotech industry concerning the adverse impact of the bill are highly speculative. Industry is also not fond of CIRM's rules.

Although the Kuehl bill is up for a nominal public vote, without a nod from the Senate leadership, the bill is not likely to be removed from the suspense file.

The staff of the Appropriations Committee has prepared an interesting analysis of SB771 that indicates that the measure would generate $56 million more for the state over a given period than would CIRM's regulations. Here are some excerpts:
"Based on a direct comparison of state revenues generated under SB 771 and under the CIRM regulations, SB 771 would produce more revenue than the CIRM regulations. In a ten year projection of a sample project modeled under three scenarios (a licensed invention, a low success royalty, and a high success royalty) with an $8 billion public investment, SB 771 would have produced $183.5 million compared to $127.7 million under the CIRM proposed regulations.

"The California Institute for Regenerative Medicine believes that the sample comparison above is misleading, that financial market forces, the interests of private research companies, and the unique nature of cellular therapies will produce disincentives which will substantially reduce the projected returns of 771."
The analysis said it reviewed economic studies of potential Prop. 71 returns although it did not cite them by name. It said the studies projected royalties to the state of between $160 million and $1.1 billion.

Earlier this month, an item appeared on the Internet that bears on the biotech industry position that anything that promises to inhibit returns on stem cell products (such as SB771) will discourage research. In an item called "What Price Innovation?," Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, wrote about industry arguments that Democratic national health care reform plans would choke medical research. Goozner said:
"Is there any evidence to suggest that the pace of significant medical breakthroughs can be associated with higher drug industry sales, profits, profit margins or, perhaps most significantly, R&D expenditures? Or, put another way, given the past decade's very high rates of sales growth, profit growth and R&D expenditure growth, how does one explain the steady downward decline (trend line; there is, of course, year-to-year variation) in the number of significant new drugs emerging from industry labs?"
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Tuesday, May 29, 2007

Where's the Money?

Even today headlines talk about the stem cell "gold rush" in California. And it is years after the Prop. 71 campaign financed a study that seemed to promise as much as $1 billion to the state from state-backed stem cell research.

While the headlines may reflect a paucity of imagination on the part of headline writers, the dreams of buckets and buckets of stem cell cash still energize much of the dialogue concerning ESC research.

Jesse Reynolds, writing on the blog Biopolitical Times, recently revisited the subject of stem cell swag. The occasion for commentary was an article in Nature Biotechnology.

Reynolds, who works for the Center for Genetics and Society in Oakland, said what is remarkable about the piece is what's missing. He wrote:
"There’s no reference to the over-the-top -- yet widely-cited -- optimistic scenarios spun in an economic analysis that was widely touted, and funded, by the campaign to establish the (California) state program."
Reynolds noted that Stanford University professor of health research and policy Laurence Baker was a co-author of both the Prop. 71 campaign study and the Nature Biotechnology article, a fact that Reynolds said was not acknowledged in the magazine.

Reynolds said Baker furiously backpedaled from his campaign study. Reynolds quoted the Nature Biotechnology article as saying:
"[A]t this point predicting particular breakthroughs or economic benefits would amount to little more than speculation.... New stem cell therapies will not necessarily reduce [health care] spending; indeed they may drive spending up...Forecasting and even retrospectively assessing the success of Proposition 71's IP provisions will be extremely difficult."
The economic promises of stem cell research are as of much interest today as they were three years ago. Lawmakers are currently struggling to ensure that the state does, in fact, share in any profits. The biotech industry and CIRM are opposed to that legislation (SB771), authored by State Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee.

CIRM itself is in the midst of drawing up rules for revenue sharing involving future grants to California businesses. And elsewhere in the country, other states are launching stem cell research efforts, peddling the idea that it can funnel vast economic benefits into the state. Sphere: Related Content

$30 Million California-Canadian Stem Cell Effort

California Gov. Arnold Schwarzenegger is off on a Canadian junket – privately funded – to promote stem cell research and wine, among other things.

According to some reports, he is scheduled to announce, along with Canadian counterparts, a $30 million stem cell research effort involving the Ontario Institute for Cancer Research and a cancer stem cell consortium in Ontario and California.

According to Robert Benzie of the Toronto Star:
"Schwarzenegger will disclose a new project between the University of California at Berkeley and the International Regulome Consortium, led by Michael Rudnicki, scientific director of Canada's Stem Cell Network and director of Ottawa's Sprott Centre for Stem Cell Research."
Beyond that, little was known about the project, although it appears to be an effort worked out between the researchers with the politicians weighing in at announcement time. Schwarzenegger's own Web site did not mention it on its home page this morning, which emphasized the wine aspects of the trip.

The governor's Canadian foray attracted some controversy because it was privately funded with none of the donors disclosed.

Kevin Yamamura wrote in The Sacramento Bee about the private nature of the trip, although he did include a list of some of the top corporate executives accompanying the governor.

Yamamura quoted Bob Stern, president of the Institute for Governmental Studies in Los Angeles, as saying,
"Why can't the state pay for it? It just looks wrong. Basically, you're having special interests pay for the trip. If taxpayers were paying, we'd know it's all California-taxpayer related."
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Monday, May 28, 2007

We're Back!

The California Stem Cell Report will begin postings anew later today. We have spent much time in the Sea of Cortez and later on land in Mexico, preparing our salty home (a sailboat) for a bit of a rest during the next few months. It may not be much of a rest for us, however. Our major assignment will be to help care for some grandchildren for a bit. The sweet little things aside, you all can look forward to more exciting California stem cell tales beginning shortly. Sphere: Related Content