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CSCR Statement to IOM-CIRM Performance Inquiry

CSCR Statement to IOM-CIRM Performance Inquiry

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Published by DavidJensen
This document was uploaded by the California Stem Cell Report. californiastemcellreport.blogspot.com
This document was uploaded by the California Stem Cell Report. californiastemcellreport.blogspot.com

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Published by: DavidJensen on Jan 25, 2012
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01/26/2012

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California Stem Cell Report
Publisher/Editor, David Jensencaliforniastemcellreport.blogspot.comdjensen@californiastemcellreport.comStatement to IOM-CIRM review panel Jan. 24, 2010Ladies and gentlemen:My name is David Jensen, and I would like to offer some thoughts on the California Institute for Regenerative Medicine, including some of the issues that may be appropriate for your distinguished panel to address. But first let me give you some background about myself.I have been writing about the stem cell agency since January 2005 and have posted more than 3,100items on the California Stem Cell Report. I have also authored articles on the agency that haveappeared in BioWorld, Wired.com, Fiercebiotech, Healthycal.org and The Sacramento Bee, the leadingnewspaper in the state capital.I am a retired journalist, having spent decades in the business. As a reporter, I covered state politics andgovernment, among other areas. I later spent two years and one week working as a press aide for thegovernor of California, Jerry Brown, in his first term in office including his election campaign. I wasexecutive business editor of The Sacramento Bee for 10 years, during which time I directedinvestigations that won awards in California and nationally. Later, as special projects editor, I handledmajor investigative pieces, including the 1994 Pulitzer Prize-winning series, the Monkey Wars, whichdealt with issues connected to primate research and the assaults by so-called animal rights advocates.I come to you from a public policy perspective, which has been the focus of the California Stem CellReport, along with sidetrips into the biotech business and economics.The California stem cell agency is unprecedented in the history of the nation and California. It is thefirst state agency to fund scientific research with billions of dollars – all of it borrowed. CIRMoperates with autonomy that is unique in California government. Cash continues to flow to it regardlessof the financial condition of the state. By law, the governor and the legislature cannot touch CIRMfinances. The agency was created by a ballot initiative – not lawmakers – in 2004 in a move to sidestepthe NIH, which was entangled in a presidential order that prevented it from funding human embryonicstem cell research. Some say that the solution offered up by the Proposition 71 ballot initiative – andCIRM – might well be the answer to solving other intractable problems that continue to stymielawmakers. Beyond that, CIRM represents a unique confluence of big science, big business, bigacademia, big politics -- not to mention religion, morality, ethics and life and death. All this whileCalifornia is mired in a lingering financial crisis that has given the Golden State the worst credit ratingof any state in the nation.While it is not in your charge to answer the question of whether the stem cell research program is the best way right now to spend $6 billion (including interest) in California, it is a question that goes to theheart of the organization. It is also a question that is likely to be addressed in one form or another asCIRM faces the prospect of raising more billions if it wants to continue its efforts. CIRM must have theconfidence and support of the state's elected leaders and voters if it is to succeed and prosper in thefuture.
 
While Prop. 71 was aimed at taking politics out of stem cell research, CIRM is very much a creature of the political process. It was created through a $30 million election campaign. Roughly one-quarter of the campaign funds were raised from one venture capital firm, which has invested heavily in a businessthat is now the recipient of $7 million in CIRM cash. .(http://californiastemcellreport.blogspot.com/2010/06/campaign-contributions-kleiner-perkins.html)Another election campaign for additional bond funding will require tens of millions of dollars. Backersof the effort will have to tap the industry that is likely to benefit, which, of course, raises some perception problems, at the very least. The agency, as well, will be under heavy pressure todemonstrate concrete results that can be presented to the California people as a benefit with the promiseof much more to come.In 2004, Proposition 71 was sold as hope – not science. That is not likely to change much in a couple of years. That's because people are not really interested in experiments with odd things that they cannottouch or see unless they believe the research will relieve suffering – or make money.The stem cell agency, which has been widely and justifiably criticized for its failure to engage the biotech industry, is now rushing to embrace it. CIRM can and should work closely with industry. But itis a delicate dance. CIRM is not only what some might call a partner with industry, it is a regulator andsomething of a venture capitalist. Its primary responsibility is to generate value for the people oCalifornia. CIRM's interests are not necessarily the same as the interests of a for-profit enterprise thatmay be funded by CIRM.CIRM's desire to help industry and generate results could lead to situations where both the appearanceand reality of its dealings are less than salubrious. Something along those lines occurred just last year with the approval of a $25 million loan to assist in Geron's now-abandoned clinical trial. Geron'sapplication was handled last May in a unique and unusual manner that deviated sharply from other grant rounds. At the time the CIRM board approved the Geron loan, the agency failed to provide ascientific score on Geron's application, which has been standard practice on more than 1,000 other applications, including other businesses. CIRM failed to provide the usual summary of grant reviewer comments that were also provided on all previous business and academic applicants. The three other applicants in the $50 million round all withdrew prior to presentation to the CIRM board – another firstin CIRM's grant program. And no public explanation was provided at the time for the departures fromlong-established procedures used for more than 400 other approved grants and loans.(See http://californiastemcellreport.blogspot.com/2011/08/californias-25-million-loan-to-geron.html)The stem cell agency has an impressive array of built-in conflicts of interests, which the agency workscarefully to manage with respect to both the law and their appearance. However, nothing can changethe appearance of some of the problems. As far back as 2008, the journal Nature warned of cronyismat CIRM. Today, $1.1 billion of the $1.2 billion in CIRM funding so far has gone to institutions tied tomembers of the CIRM governing board. It is fair to say that if California voters had foreseen thatsituation, they would not have approved creation of the stem cell agency.One recommendation for your panel to consider is a restructuring of the board, which would requirevoter approval, to both shrink its unwieldy size and to remove a healthy chunk of the conflicts.Another matter to consider is public disclosure of at least the statements of the economic interests of grant reviewers. Currently those statements(along with their professional conflicts) are hidden from

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