Wednesday, April 15, 2009

The California Stem Cell Story: Safety, Waste and Promises

The story was about CIRM, and the headline said,
"Stem-cell stalemate: The push for cures may produce only disappointment - or worse."
Written by Peter Jamison for the San Francisco Weekly, the lengthy and thorough-going article explored the promise of California's $3 billion stem cell research effort and how it measures up. Jamison focused on CIRM's move towards pushing therapies into the clinic and away from basic stem cell research.

The article appeared in a free newspaper that reports 100,000 weekly circulation with 500,000 monthly readers and 1.5 million page views (presumably weekly) on its Web site.

Jamison said that when Prop. 71 was passed in 2004, it was fueled "by promises of cures and therapies that appeared, to the layperson, little short of miracles." He wrote,
"Many in the medical community, while paying lip service to the optimism of 2004, acknowledge the very real possibility that people suffering from the incurable conditions typically associated with stem cells — not just Parkinson's or diabetes but Huntington's disease, multiple sclerosis, and HIV/AIDS, among others — will not see a therapy or cure from the state's $3 billion investment."
Jamison continued,
"In short, the question is whether CIRM should become an agency that pays tens of millions of dollars to alleviate arthritis while research languishes on Huntington's disease or multiple sclerosis. This approach could go a long way toward addressing the more serious safety concerns voiced by some scientists. It is also a remarkable detour, by any standard, from the ambitious medical goals that drove Prop. 71. It is difficult to overlook the irony of a situation in which state officials, seeking to deliver on the promises of a ballot initiative intended to overcome the Bush administration's supposed limits on the advance of science, turn for their salvation to research Bush never restricted in the first place. Will California voters accept such a momentous policy shift?"
Jamison interviewed a wide range of scientists including those at CIRM. He quoted Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UC San Francisco, on the risks of CIRM's turn towards the clinic.
"The likelihood of something going wrong is pretty high. Something like tumors are probably going to happen. This is an area where the risks are great. The public has to be prepared."
Marie Csete, chief scientific officer at CIRM, took another view. Jamison wrote that "she was quick to counter suggestions that the agency's new funding priorities would put patients in danger."

Csete said,
"'It's just a ridiculous idea that we're not putting safety first....This field is moving very quickly toward clinical application. There's no question in my mind, and it would be silly for us to say that we have to solve every single problem before we proceed to transplantation' of cells into humans."
Hans Keirstad of UC Irvine was quoted as saying,
"'You will always garner respect by saying, 'Slow down. More science is necessary....Somewhere out there there's got to be compassion for those patients who are dying. I would go so far as to say that inaction is killing people. The views of ultraconservative scientists are killing people.'"
Waste was another topic. Jamison quoted Bruce Conklin, a senior researcher in the Gladstone Institute's cardiovascular disease division, as saying,
"'We all want the same thing — we want to see regenerative medicine work....Although there's $2 billion [of CIRM money] left to give out, that's actually a very small amount of money. Now, if that's all spent on clinical trials that don't tell us anything because they don't work, that's a missed opportunity.'"
Warner Greene, director of the Gladstone Institute of Virology and Immunology, said,
"There's no way to hop over this basic biology."
Jamison additionally interviewed Jeff Sheehy, one of the 29 persons on the CIRM board of directors, who talked about an "identity issue" at CIRM. Jamison wrote,
"'If we are going to say that we're going to work with adult stem cells, we can be in the translational phase and the clinic now,' says Sheehy, who is communications director for UCSF's AIDS Research Institute and represents the interests of HIV patients to the board. 'While they're going to be of benefit to a great many people in California, these adult-stem-cell approaches are probably not going to have a big impact on these severe degenerative diseases that really motivated a great number of people to support Prop. 71, like Alzheimer's, Parkinson's, spinal-cord injuries.'"
Many of the issues addressed by Jamison are part of the current review of the CIRM strategic plan. The agency last month conducted two public hearings on plan and its proposed changes. You can find the transcripts here under the topic "interested persons meetings." The latest version of the plan may well surface at the CIRM directors meeting April 28-29 in Los Angeles.

But for many, Jamison wrote, CIRM's activities are more than a debate about strategy and basic research vs. translational research. He said,
"Whatever the voters who supported Prop. 71 think of the use of their money to support adult stem-cell cures for relatively pedestrian ailments, they would almost surely be angered if the ballot initiative's billions of dollars have bought, after a decade, only a sheaf of much-lauded studies in the journal Cell.

"Even angrier, no doubt, would be the people who suffer from the diseases stem cells might one day cure. Their voices, more than any others, persuaded a majority of the state electorate to support Prop. 71."
We asked Don Gibbons, chief communications officer for CIRM, if the agency had a comment on the article for this item. He replied,
"I just hope you encourage your readers to read the entire article and not just the negative snippets you choose to use."
We certainly hope that you all take a look at Jamison's piece, which airs, in a very public way, some important scientific and policy questions that have not yet been widely examined in California.

Your comments are invited on this and any other topics. Click on the word "comments" below to send them in unmoderated. Anonymous comments are permitted.

(Editor's note: An earlier version of this item incorrectly attributed the "hop-over" quotation to Bruce Conklin, not Warner Greene.)


  1. Here is a link to the SF Weekly story:

  2. Thanks for pointing out the missing link.

  3. Anonymous4:04 PM

    Jeez, can Gibbons say anything nice? Who pays his salary? Oh, yeah, we do...what a waste. I felt your synopsis of the story was fair and the story itself was reasonably good. THERE IS AN IDENTITY CRISIS AT CIRM. What is the agency's role? It was set up specifically to fund what the feds refused to fund. Now, as Jamison's article notes, CIRM is aimless. Maybe Gibbons should spend some time figuring out that question. And don't give me tired BS about the shoddy strategic plan he cooked up with Alan, frequent-flier-freak, Trounson. They didn't even consider that the federal ban would be lifted even though the first plop of that steaming cow patty of a plan hit the ground after both nominees had pledged to overturn Bush's executive order.

  4. Dave,

    Peter Jamison's SF Weekly piece was a thorough look at the tensions CIRM now faces between those who favor basic research and those favoring more translational research.

    I believe more translational efforts make sense, particularly now that NIH is expected to resume funding. Traditionally the NIH has tended to emphasize basic research.

    Two things are essential:

    1. There should be a thorough public debate on the appropriate policy course.

    2. CIRM should seek a closely collaborative relationship with NIH to avoid duplication.

    CIRM has had two public hearings on its proposed strategic plan revision and some of these issues were aired at both sessions.

    It will be interesting to see how CIRM staff takes that input into account as it tweaks the plan for presentation to the ICOC.

    Best regards,
    John M. Simpson
    Stem Cell Project Director
    Consumer Watchdog


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