'Tough Lesson' and Stem Cells: More Time, More Money Urged -- Indirectly -- for California's Research

BioInformant graphic

Time and money, hope and hard work -- not to mention death -- were the topics today on the blog of the $3 billion California stem cell agency. 

The blog item involved more than the demise of patients waiting for a stem cell therapy but also the possible demise of the nearly 15-year-old program, unique in California history. 

The research effort, formally known as the California Institute for Regenerative Medicine (CIRM), is running out of cash. By the end of this year, it expects to have no funds for new awards. 

That situation led to a piece this morning on CIRM's  blog, The Stem Cellar. It was a bit of indirect pitch for continued funding by California taxpayers.

"Time and money are always going to be challenging when it comes to advancing stem cell research and bringing treatments to patients. With greater knowledge and understanding of stem cells and how best to use them we can speed up the timeline. But without money none of that can happen."

The article by Kevin McCormack, senior director of communications for CIRM, recapped the history of the agency, created by voters in 2004 through a ballot initiative that set the state off on the largest scientific research effort of any state in the nation. Indeed, as McCormack pointed out, the funding surpassed research budgets of some nations. The catch in California was that no source of funding for the agency was provided beyond the initial $3 billion. 

CIRM noted the high hopes for quick therapies back in 2004. 

"In the early days there was a strong feeling that this was going to quite quickly produce new treatments and cures for diseases ranging from Parkinson’s and Alzheimer’s to heart disease and stroke. Although we have made tremendous strides we are still not where we hoped we’d be. 

"It’s a tough lesson to learn, but an important one: good scientific research moves at its own pace and pays little heed to our hopes or desires. It takes time, often a long time, and money, usually a lot of money, to develop new treatments for deadly diseases and disorders."

McCormack briefly catalogued some of CIRM's progress and the 56 clinical trials in which it has invested, some of which are in the final stage before federal approval of a treatment. 

But CIRM said, 

"The simple truth is that unless we, as a nation, invest much more in scientific research, we are not going to be able to develop cures and new, more effective, treatments for a wide range of diseases." 

The agency is hoping that voters will approve a ballot initiative in November 2020 that will provide $5.5 billion more for stem cell research. In the meantime, it has $71 million to hand out.

Japanese and California Stem Cell Affairs: An Opportunity to Make a Connection

This baby is a spin-off in Japan from CIRM-financed research.  Kazuhiro Kawamura 

of the St. Mariana School of Medicine delivered the child, which he is holding.

 (Kawamura photo)

Scientists and other stem cell fanciers in Japan will have their first chance this Thursday to take part in a meeting of the governing board of the $3 billion California stem cell agency.

Ken Burtis
UC Davis photo

That's because one of the board members, Ken Burtis of UC Davis, is in Nara, Japan, for a visit on the day of the meeting in Burlingame, Ca. He will be linked to the session via a telephone connection. It will be a two-way hookup that the public can use to participate, a requirement of California state law.

Stem cells are a hot scientific and commercial topic in Japan. According to an article last November in the Japan Times, the country's regenerative medicine market is expected to climb to $15.85 billion in 2030, up from $260 million in 2012. Japan is also the home of the induced pluripotent stem cell, which was first produced there.

Burtis is a professor of genetics and provost at UC Davis. It was not immediately known whether his visit to Japan involved UC Davis, the stem cell agency or was personal.

Burtis' access to the stem cell meeting, which includes a lengthy briefing on the agency's development portfolio, will be from the Hotel Nikko in Nara. Interested parties will be able to participate from the room in which Burtis is monitoring the meeting. However, the meeting agenda does not specify a room number. That will have to be obtained by emailing the stem cell agency at info@cirm.ca.gov. It is best to do that well in advance of the meeting.

This week's meeting has nothing specific on the agenda related to Japanese stem cell affairs, but stem cell research is a global matter. Researchers and others in Japan may well learn something new, particularly from the briefing on the agency's portfolio, and will have an opportunity to pose questions. Additionally, the board will be considering $72 million in "concept" proposals to speed commercialization of stem cell research, which could well be of interest to Japanese stem cell researchers and biotech firms even if they are not eligible for awards.

The California stem cell agency, which is known as CIRM, has also had a collaborative arrangement with Japan Science and Technology Agency since 2008.

Masaya Nakamura
Keio photo

Aileen Anderson
UCI photo

The agreement has resulted in one collaborative funding project involving Aileen Anderson of UC Irvine and Masaya Nakamura of Keio University. Anderson has received $1.3 million from CIRM, which did not announce the amount of funding that Japan provided to Nakamura.

Aaron Hsueh
AFP photo

Aaron Hsueh of Stanford received $2 million from CIRM for work that later led to a novel way of treating some forms of infertility and further work with Japanese researchers. One child has been born in Japan using the techninque. Kazuhiro Kawamura (pictured at the top of this item) and others at St. Mariana University School of Medicine were involved in that effort, which was not funded by CIRM. Another woman was pregnant as of October 2013. No information about the result of that pregnancy was immediately available. (See here and here.)

(Editor's note: This item has been altered slightly from the original version to make it clearer what is on the agenda this Thursday and its relationship to Japan. The headline has been reworded. No information has been dropped.) 

California Stem Cell News: A Not-So-Good Story Line

If one is to believe Google, the top of the news today about the California stem cell agency is a story that relates how its $3 billion effort has failed to deliver on the emotion-ladened campaign promises of 2004.

The piece in the Los Angeles Times, the state's largest circulation newspaper, was ranked No. 2 in a Google news search this morning on the term “California Institute for Regenerative Medicine.” Ranked at No. 1 was a summary of the article. Yahoo news placed the Times article a tad higher than Google, declaring it was No. 1.

The story yesterday by Jack Dolan of the Times' Capitol bureau follows one earlier this month in the New York Times that warned that California voters are not likely to see a good return on their unprecedented investment in stem cell research.

Both stories highlight one of the major challenges facing the state stem cell agency, especially if CIRM seeks another $3 billion to $5 billion from voters in a couple of years.

To win approval of such a bond measure in a statewide election, it will take more than a few hundred research papers, one of the measures of success that CIRM uses. The papers may contribute to the development of the science, but voters expect more tangible results. They want to see paralyzed people walk, blindness cured and memories recovered – all of which are not likely between now and time for an election for more funding for CIRM.,

That is not to say that another bond measure is doomed, but it will take some great science and top-notch marketing – not to mention luck – to win approval of more cash for research.

The story that CIRM wants to see should be much different than Dolan's piece, which does not give the agency much to celebrate, at least in terms of PR.

Dolan wrote,

"Under (CIRM Chairman Robert Klein's) stewardship, the agency has funded research leading to hundreds of scientific papers, but scientists say marketable therapies for maladies such as cancer, Alzheimer's and spinal cord damage promised during the campaign remain years, if not decades, away."

Dolan cited the built-in conflicts of interest at CIRM. He wrote,

"'When you're talking about spending $1.1 billion dollars, there's absolutely no excuse for people making the decision to give themselves the money,' said Robert Fellmeth, executive director of the Center for Public Interest Law at the University of San Diego.

"While board members recuse themselves from voting on grants where they have a direct conflict, the mere presence of so many conflicted members is a concern, Fellmeth said. 'There is a quid pro quo atmosphere that develops, because you defer to each other.'"

Dolan additionally hammered at the high salaries at the upper levels of CIRM, a matter that resonates roundly and negatively with voters.

Little of what he wrote is new to the readers of this blog, but a piece in the Los Angeles Times reaches a new and far wider audience than that of the California Stem Cell Report. A story in the Times also stimulates additional links to the article, sometimes in a manner that does not cast CIRM in the best light.

The Scientist magazine linked to the story in a three-paragraph item that began like this:
“The California Institute for Regenerative Medicine has been plagued with criticisms and doubts during its first six years in operation, yet the chairman of the institute plans to ask state voters for another $3 billion in bonds in 2014 to keep the institute up and running.”

Then there was this headline from blogger Wesley Smith: “CIRM to Try and Sucker Californians Into Letting It Borrow Even More Money." Smith wrote,

"Who cares that California is falling into the ocean fiscally?  Who cares that our taxpayers are groaning under high taxes and an astonishing level of bond debt?  Not the California Institute of Regenerative Medicine.  Like the man-eating plant in (the play) 'Little Shop of Horrors,' its appetite is insatiable.  It wants more!"

Rankings of news stories on Internet search engines, of course, change over time, sometimes in a matter of hours. But pieces such as those in the New York and Los Angeles Times will still be part of the news background for CIRM come election time. Reporters from around the state and nation will find them as part of their coverage of the bond measure. More questions will be asked. And CIRM will need to find some good answers.

CIRM Grantees Get More Than Cash

Earlier this month, CIRM grantees assembled for a two-day session to talk about their work and hear some of the leading folks in the field air their own views about stem cell research.

Those of you who did not get to attend can share a bit of the experience via a 146-page report coming out of the conference. Of particular interest are one page summaries of 129 research projects involving CIRM grantees.

There was also this from Alan Trounson, president of CIRM,

"The experiment of Proposition 71 is a critical model for funding innovation that is being closely examined worldwide as a new investment by the community in improving human social values and health....

"Investment in quality of life through the support of stem cells and regenerative medicine needs to be demonstrated to have been a wise choice. Our grantees are the vanguard of this investment in science, and we need to be able to clearly demonstrate the benefits this investment will make in the general community. In the end this will have to be shown as treatments in the clinic in the form of new drugs, cell therapies, gene therapies, tissue engineering etc., for some of the most debilitating diseases and injuries presently costing the society and individuals dearly."