California's 'Incredible' Stem Cell Invention

C. Randal Mills - CIRM 2.0. Building a better stem cell agency (Part 2) from MCC Industry Relations on Vimeo.

Randy Mills, the president of the $3 billion California stem cell agency, was selling hard a couple of months ago in San Diego.

Animated and gesticulating, Mills said,

"There's nothing like CIRM.  It's an incredible invention that probably only could have taken place in California."

But he said the agency was on its way to being better and faster, delivering cash to researchers in 120 days instead of the previous average of 22 months.

"We are an accelerating agency. We are in the time business. So we can't be slow...Urgency matters."

Mills' comments were made to a symposium at the Moores Cancer Center in San Diego Feb. 19. But his full remarks surfaced recently in a video posted on Vimeo(see above).

Mills took only a little more five minutes in his presentation about CIRM 2.0, his radical overhaul of the agency's grant-making process. He is seeking higher quality applications, higher success ratios and stronger partnerships with researchers and patient advocates.

CIRM  2.0 is still in the process of being fully implemented in all of the agency's award efforts. Mills said there will be bumps.
"Buckle up. It's going to be a wild ride."

'Born in Hype:' The California Experiment and Stem Cell Research

A California newspaper with a daily readership of 1.5 million this week thrashed the field of stem cell science, declaring that it “is slathered with so much money that immoderate predictions of success are common.”

“Infected with hype” is the way the headline put it on the March 31 piece in the Los Angeles Times. The paper has the largest circulation in the state and is an agenda-setter for much of the state’s mainstream media.

The comments came in an article by Pulitzer Prize-winning columnist and author Michael Hiltzik, who holds the California stem cell agency in low regard.

Kalina Kamenova
 U. of Alberta photo

Timothy Caulfield
U. of Alberta photo

His starting point was a study in Science Translational Medicine by Timothy Caulfield and Kalina Kamenova of the University of Alberta law school.  Their content analysis research focused primarily on newspaper coverage of timelines for stem cell therapies before and after Geron bailed out of the first clinical trial for a human embryonic therapy in the United States. They did not have warm words for scientists as public communicators.

Neither did Hiltzik, but he also faulted the media. He wrote, 

“The authors mostly blame the scientists, who need to be more aware of ‘the importance of conveying realistic ... timelines to the popular press.’ We wouldn't give journalists this much of a pass; writers on scientific topics should understand that the development of drugs and therapies can take years and involve myriad dry holes and dead ends. They should be vigilant against gaudy promises.”

Hiltzik then took on the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is known.  He wrote about the cash that was "slathered" about. He said,

“The best illustration of that comes from California's stem cell program -- CIRM, or the California Institute for Regenerative Medicine -- a $6-billion public investment (including interest) that was born in hype. 

“The promoters of Proposition 71, the 2004 ballot initiative that created CIRM, filled the airwaves with ads implying that the only thing standing between Michael J. Fox being cured of Parkinson's or Christopher Reeve walking again was Prop. 71's money. They commissioned a study asserting that California might reap a windfall in taxes, royalties and healthcare savings up to seven times the size of its $6-billion investment. One wouldn't build a storage shed on foundations this soft, much less a $6-billion mansion.”

 He wrote about how CIRM played a dubious role in funding the Geron clinical trial only a couple of months before the company pulled the plug for financial reasons, something that the California Stem Cell Report has dealt with as well.  The $26 million loan to Geron involved a major departure from the agency’s normal procedures.  Abandonment of the trial also raised ethical questions that should be of continuing concern to the agency and its ethical advisors who are meeting today and tomorrow in Los Angeles.  

Caulfield’s views on stem cell hype are well-known in the small stem cell research community. But rarely does his sort of perspective, which is shared by others in the field, reach a mass audience such as the 1.5 million readers of the Los Angeles Times.

All of which poses a challenge for the California stem cell agency whose finite amount of cash is now expected to run out in 2020. As Hiltzik noted, the overblown expectations led voters to believe that miraculous cures were just around the corner.

Today, more than a decade after creation of the agency, the promised cures have not materialized and none are likely for some years. The agency has undoubtedly made a major contribution to stem cell science. But the unfulfilled promises of the campaign hype gave its foes the kind of tools they need to battle any efforts to provide more state funding for the agency.  How CIRM deals with that scientific and PR challenge will be one of the major tests for it over the next several years.

Moratorium on Possible Genetic Alteration of Human Race on Agenda Tomorrow at California Stem Cell Agency

The select panel that helps the $3 billion California stem cell agency set  research standards meets tomorrow and Friday in Los Angeles, its first session since 2013.

The agenda appears modest but it does include a discussion involving possible genetic modifications to the human race and the germ line letter signed by Nobel prize winner David Baltimore, among many others.

The starting point for the discussion is a statement by the International Society for Stem Cell Research that said,

“The International Society for Stem Cell Research calls for a moratorium on attempts at clinical application of nuclear genome editing of the human germ line to enable more extensive scientific analysis of the potential risks of genome editing and broader public discussion of the societal and ethical implications.” 

Scientist Paul Knoepfer of UC Davis has an ongoing look at the issues on his blog, ipscell.com. The latest is a March 29 piece headlined “Genetically Modified Humans Now Inevitable?” Knoepfler wrote, 

“Rumors are swirling that upwards of four papers reporting production of GM(genetically modified) human embryos are in various stages of review at high-profile journals, sparking a sense of urgency for some kind of steps to deal with this new reality. Could these papers report germ line correction of the CTFR mutation in cystic fibrosis or of a BRCA1 mutation? Were these GM human embryos used to make embryonic stem cell lines or are they cryopreserved?

“The prime concern now is that GM human embryos could in principle be rather simply turned into GM humans at any one of thousands of IVF clinics around the world with a surrogate mother. That simple technological step of going from GM human embryo to GM human being of course invokes incredibly complicated, thorny legal, bioethical and societal issues.”

Although Baltimore once served on the stem cell agency’s governing board and the agency has been active with the international stem cell research group, it is not clear that it will do anything in regard to a moratorium.

The agency board has shied away from such matters since 2011, when Robert Klein left as its chairman. He often pressed for the agency to take on legislative and other policy matters during his tenure.

The moratorium is not scheduled to be officially voted on so legally it would difficult for the standards panel to do anything significant. But the group could make an expression of sentiment and ask that the full board consider the matter.

The standards group’s last meeting was Oct. 1, 2013, according to the CIRM Web site. However, it was quite active in the early days of the agency when it was formulating the first comprehensive stem cell research regulations in the country. 

The public can attend tomorrow’s session, which beings at noon PDT in Century City in Los Angeles, and speak to the committee on any matter. 

Here is a link to a list of its members. Its chairman is Bernie Lo of UC San Francisco.