Friday, October 30, 2020

Prop. 14 News Coverage: Los Angeles Times and Politico Take a Crack at the Stem Cell Measure

A $5.5 billion ballot measure to save the California stem cell agency from financial extinction popped up in coverage this week in the Los Angeles Times and Politico, a national political and government news service. 

Both pieces raised questions about the agency and its history, not to mention whether it fits with California's current government priorities.


In his piece, George Skelton, a longtime political columnist for the Times, the largest circulation newspaper in the state, noted that the agency was funded in 2004 with $3 billion, which is now running out. Skelton wrote, 
"That’s a ton of money for a little-noticed agency that provides a questionable state service. But many of the research projects have been very worthwhile." 
In the article, the Proposition 14 campaign, headed by Palo Alto developer Robert Klein, also continued its pattern of making exaggerated or misleading claims.  
"If we don’t continue the state funding, lots of facilities would have to close their doors,” says Kendall Klingler, the Proposition 14 spokeswoman....

"'We have more than 90 stem cell trials underway,' she says.

"The agency does have a record of some success: funding research that has led to treatments approved by the Food and Drug Administration (FDA) for blood and bone marrow cancers, for example."
Regarding the number of clinical trials funded by the research program, the agency itself only claims 64. The additional 30 or so trials are not funded by the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. They utilize a piece of CIRM-financed research, however tiny, someplace along the way. And not necessarily a significant piece. 

The FDA treatments mentioned are not stem cell treatments, which is what was promised by the 2004 campaign. The agency has not funded any research that has resulted in a stem cell therapy that is available to the general public. 

And it is simply not accurate to say that "lots" of stem cell facilities partially financed with CIRM cash will be closing. All of them are occupied and fully in use. The recipients of the facilities grants, such as Stanford and UC San Francisco, are exceedingly unlikely to close the buildings.

Skelton concluded that CIRM has "failed to live up to its original hype." He said, 

"It was aloof to Sacramento, and not subject to oversight by the Legislature and governor. There’s been a lack of transparency.

"There was also an odor of interest conflicts among agency board members who seemed to steer grants toward their own institutions, even though they recused themselves from voting."
(In the interest of full disclosure, I worked for Skelton in the Capitol bureau of United Press International in the 1970s when he was bureau chief there.)

Over at Politico, Victoria Colliver wrote,  
"It's not clear that the Yes on 14 campaign's $15 million, even with a campaign that features actor Seth Rogen as “Stemmy the Stem Cell," will get the job done.

"'We’re running against Covid-19. That’s our real opposition,” said Robert Klein, the wealthy real estate investor and attorney who authored both measures and is the main funder of Prop. 14, along with Dagmar Dolby, the widow of inventor and sound engineer Ray Dolby.

"The differences between 2004 and 2020 are stark.

"Back then, Klein and other proponents had a ready-made argument by pointing to President W. Bush's prohibition on federal funding for embryonic stem-cell research, a stance supported by the religious right. In the nation's biotech capital — with an electorate dominated by Democrats and independent voters that support abortion rights — stem-cell backers made the case that California needed to step in to keep research alive.

"Many of the promises made 16 years ago, including its projections in royalties and state revenues from new treatments, have not borne out. Funding from the agency has supported more than 60 clinical trials, but CIRM has yet to fund a single stem-cell therapy approved by the U.S. Food and Drug Administration for widespread use."

Thursday, October 29, 2020

Prop. 14 News Coverage: Campaign Chicken Feed and Editorials

The Biopolitical Times this week briefly explored campaign spending on Proposition 14, newspaper editorials and opposition to the $5.5 billion stem cell research measure on this fall's California ballot.

The piece by Pete Shanks, who has followed the state stem cell agency for a number of years and opposes the measure, called the $18 million spent on behalf of Proposition 14 "almost modest." It is actually chicken feed compared to the more than $700 million spent so far on California on all ballot propositions.

Indeed, the $18 million is smaller than many grants from California's stem cell agency, which would be refinanced and significantly expanded under Proposition 14. A substantial number of the agency's grants run about $20 million. 

Several years ago, Robert Klein, the Palo Alto real estate developer heading the campaign, told the California Stem Cell Report that the effort would cost $50 million. However, the more modest $18 million may be the product of a difficult fundraising environment this year rather than reflecting what is needed to win approval of the measure. Or it could be a lack of enthusiasm among potential major donors.  

Known officially as the California Institute for Regenerative Medicine (CIRM), the agency is scheduled to begin closing its doors this winter without a substantial infusion of cash.

Shanks also tallied up newspaper editorials on Proposition 14 and said, "Overall, the  'NO' publications seem far more impressive." Many of the major newspapers in the state oppose the measure, including the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle, which spent months in 2018 analyzing the operations of the stem cell agency, also opposed Proposition 14. 

Shanks noted that Zach Hall, the first president of the agency, says the agency has served its purpose and no longer is needed. The California Stem Cell Report on Monday first reported Hall's position. 

The Biopolitical Times is produced by the Center for Genetics and Society in Berkeley, Ca., which opposed creation of the stem cell agency in 2004.  
*****
Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Monday, October 26, 2020

Proposition 14: The Latest News and Opinion, STAT to Capitol Weekly

The national biomedical news service STAT today took a look at California's $5.5 billion stem cell measure, declaring it was backed by a "well-financed campaign that’s making heady promises about curing diabetes, paralysis, cancer, and Parkinson’s and Alzheimer’s diseases."

The headline on the story by Usha Lee McFarling said,
"With wildfires burning and Covid-19 spreading, can California afford stem cell research? Voters are set to decide"
McFarling's story was one of the more detailed that have appeared so far either nationally or within California.

She had this observation from a Los Angeles specialist on ballot initiatives, which is the direct democracy tool that Robert Klein, a Palo Alto real estate developer, used to place Proposition 14 on the ballot.
"John Matsusaka, an economist who heads the Initiative and Referendum Institute at the University of Southern California. He said federal funding restrictions that fueled support of Proposition 71 are no longer a major concern, proponents have not done a great job demonstrating that voters got their money’s worth from the first $3 billion, and the measure is coming to voters during tough fiscal times." 
In 2004, Proposition 71, also created by Klein, established the state stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM), and provided it with $3 billion. The money is nearly gone.  CIRM is set to begin closing its doors this winter unless Proposition 14 is approved. 

Mentioned or quoted in the STAT story were Alan Trounson, former CEO of CIRM, researchers Larry Goldstein of UC San Diego, Irv Weissman of Stanford, Jeanne Loring of Aspen Neurosciences, Inc., Andy McMahon of USC, and Jan Nolta of UC Davis. Others included CIRM governing board members Joe Panetta and Jeff Sheehy, and Melissa King, executive director of Americans for Cures and the head of field operations for the campaign group "Yes on 14." 

The STAT piece dealt with the range of pro and con arguments, including conflicts of interest. 
"'The people who decide who is going to get funded are the people who get funded. That’s a built-in conflict of interest they made no attempt to fix,' said John Simpson, who monitored CIRM for many years as stem cell project director for the group Consumer Watchdog. 'They need to go back to the drawing board and fix these structural flaws.'"

"Some of the conflicts have been so flagrant as to be almost comical. For example, former CIRM President Alan Trounson once asked prominent biochemist Leroy Hood to be a reviewer of a grant by Irv Weissman, the director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, after the three men spent time fly fishing together on a Montana ranch jointly owned by Weissman and Hood."
Also appearing today was an opinion piece on the Capitol Weekly online news service by Pete Shanks, who has written about CIRM for years on the blog, Biopolitical Times. 

He cited the much-discussed issues surrounding the stem cell agency and wrote 
"Proposition 14 could have addressed these defects. Instead, it made them worse: It enlarges the board to 35 members, still mostly drawn from representatives of the universities, companies, and research institutes that receive its grants."
Shanks also said, 
"The 2004 proposition campaign has been widely criticized for hype: over-promising the imminence and certainty of breakthroughs. The advocates called their operation 'Cures for California,' but these have been in short supply. They also said that stem cell research would enormously reduce California’s medical costs, but there’s no sign of that.

"The campaign for Proposition. 14 follows the same pattern. It claims that the new multibillion-dollar investment has 'massive savings potential' and a 'low impact' on the budget. Skepticism is definitely in order."

*****

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author. 

Proposition 14: First CEO of California Stem Cell Agency Says $5.5 Billion Stem Cell Measure Not Needed

Zach Hall, UCSD photo
The first president of the California stem cell agency, Zach Hall, says that he would vote against the $5.5 billion ballot measure to save the research enterprise from financial extinction if he still lived in California.

Hall, now retired and living in Wyoming, says a justification for agency existed in 2004 when it was created by voters via another ballot measure, the $3 billion Proposition 71. 

But, according to the new book, "California's Great Stem Cell Experiment," Hall says "that the rationale and need are not so evident today for a state-supported agency dedicated to stem cell research."  

The creation of induced pluripotent stem cells has largely supplanted the use of cells derived from embryos, Hall said. The Bush Administration restrictions on human embryonic stem cell research were major drivers for Proposition 71, but those have now been lifted.

Hall said that the National Institutes of Health could likely support most of the stem cell work that is now backed by CIRM.

Proposition 14, the $5.5 billion ballot initiative, would refill the stem cell agency's coffers. The program is running out of the $3 billion provided in 2004 and will begin  closing its doors this winter without major funding. 

Hall was president and CEO of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, from 2005 to 2007 and drew up the agency's first strategic plan. During his long career, Hall was also director of the National Institute of Neurological Disorders and Stroke in the 1990s, executive vice chancellor at UC San Francisco, CEO of En Vivo Pharmaceuticals and a director of the New York Stem Cell Foundation.

Interviewed for the book, which was authored by this writer, Hall said that he has no regrets about serving as its first president, a job he largely enjoyed. 

Hall said that Proposition 71 of 2004 served an important and useful purpose. It helped to re-energize the stem field at a time when it was “disheartened and demoralized” by the restrictions of the Bush Administration.

While the 2004 measure had significant flaws, he said it was very successful at a critical time in attracting stem cell researchers to California.

“The idea that California would make this sort of commitment, I think, had a huge impact on the field,” Hall said.

 “It's certainly true that because of Proposition 71 that California continues to play a stronger role in stem cell research than it otherwise would have. But, contrary to some expectations, it is not the center of the universe of stem cell research in the same way that Silicon Valley is for information technology.

“It is one of many global centers of excellence for stem cell research. One perhaps na├»ve expectation that has not been met is an explosion of profitable California biotech companies specializing in stem cell research.”

Hall said, however, that Proposition 14 “is searching for a rationale to continue CIRM.” Hall mentioned the “amorphous” research avenues provided for in the measure: mental health, personalized medicine, “aging as a pathology” and “vital research opportunities.”

“You can use the money for almost anything,” Hall said. “This takes off a lot of the brakes on how the money can be spent.”

Given what has been learned over the last 15 years, he said he would have thought a new initiative would have attempted to improve governance and try to make CIRM work better, be more efficient and more strategic. “There's just no sense of thoughtfulness of using the expertise of getting relevant people together to think about it and come up with a plan,” Hall said.

He also said that Proposition 14 does not provide a good or transparent mechanism for making decisions about how the money is going to be spent.

“My guess is that all the board positions will be filled by constituents, people who depend on CIRM money in some way and who will be very pliable about what is to be done. Exactly the wrong way to do it.”

The California Stem Cell Report asked Hall last week if he would like to add anything to his earlier comments for the book. "One thought I might add," he replied, "concerns the idea that Proposition 14 will address the issue of the 'Valley of Death', i.e. the gap between discovering a possible therapeutic and being able to 'de-risk it' enough to attract the interest of big pharma.  What is being proposed, it seems, is that CIRM wants to act as a kind of VC (venture capitalist) with the state's money.  

"In my view, a much better approach to this problem is to find ways to encourage academic and industry scientists (both biotech and big pharma) to work together starting from an early stage of the work. This has been done effectively (and much more cheaply!) by several private philanthropic organizations.  The Michael J. Fox Foundation and Target ALS are two examples that I know of." 

Sunday, October 25, 2020

Looking for the $700,000, IOM Evaluation of the California Stem Cell Agency? Here is a Good Link

 


In 2012, the prestigious Institute of Medicine published a report on California's stem cell agency after months of studying the research program at a cost of $700,000 to the agency itself.

Directors of the agency had expected that the "gold standard" study would give the agency a seal of approval that would lead voters in California to approve additional billions for the California Institute for Regenerative Medicine (CIRM), as the agency is officially known.

The report by the IOM (now called the National Academy of Medicine) has a number of bad links to it on the Internet, and some persons have reported difficulty in finding it. Here is a link that will take you directly to the study where you can read it free online.

Here is the beginning of an article about the study when it was released on Dec. 6, 2012.

IOM Recommends Sweeping Changes at California Stem Cell Agency

A blue-ribbon study of the $3 billion California stem cell agency today said the program has “achieved many notable results,” but recommended sweeping changes to remove conflict of interest problems, clean up a troubling dual-executive arrangement and fundamentally change the nature of the governing board.

The recommendations from the 17-month study by the Institute of Medicine (IOM) would strip the board of its ability to approve individual grants, greatly strengthen the role of the agency's president, significantly alter the role of patient advocates on the governing board and engage the biotech industry more vigorously.

For more on the IOM report and CIRM's actions on its recommendations, see the new book, "California's Great Stem Cell Experiment: An Inside Look at a $3 Billion Search for Stem Cell Cures."

Proposition 14: The Scientist Magazine Digs into California's Stem Cell Agency and the Ballot Measure

The Scientist magazine yesterday published a more detailed look at the state of California's stem cell agency and a $5.5 billion ballot measure that would send it into arenas that it has previously not explored. 

The article by Katarina Zimmer said the California Institute for Regenerative Medicine (CIRM) has "helped transform its state into an innovation hub of stem cell science."  The article was more complete and detailed than many of the news pieces prepared by California media.

Quoted by Zimmer were stem cell scientists Jeanne Loring, co-founder of Aspen Neurosciences, Inc. of La Jolla; Larry Goldstein of UC San Diego, and Jeff Sheehy, who has served on the CIRM board since its inception in 2004. 

Zimmer also cited the 2012 Institute of Medicine (IOM) study that was commissioned by CIRM at a cost of $700,000. Directors of the agency expected a "gold standard" endorsement of the agency, but the IOM cited significant problems with conflicts of interest on the board. The study also recommended major restructuring of the board and the agency. 

An analysis last month by the California Stem Cell Report showed that 79 percent of CIRM awards -- $2.1 billion -- has gone to institutions that have links to past or present board members. 

Robert Klein, the sponsor of the $5.5 billion Proposition 14, did not include any of the more significant recommendations from the IOM in his 17,000-word, proposed revision of CIRM's legal charter. Klein was a strong advocate for commissioning the study by the prestigious IOM.  Klein was not quoted by The Scientist. 

Zimmer's piece covered many of the arguments pro and con on Proposition 14 that are familiar to readers of this web site. However, her piece is not likely to find significant numbers of readers among California's 20 million voters. Only a tiny fraction of them read The Scientist magazine. 

However, The Scientist does reach a significant number of persons globally that are interested in such things as stem cell research.

For more on the IOM report and CIRM's actions on its recommendations, see the new book, "California's Great Stem Cell Experiment: An Inside Look at a $3 Billion Search for Stem Cell Cures."

Friday, October 23, 2020

Proposition 14: Stem Cell Balderdash at Sacramento Bee

Has California's stem cell program "relieved the suffering of millions?” The Sacramento Bee thinks so, but the assertion is totally false. 

It was contained in an editorial today that endorsed Proposition 14, which would save the state stem cell program from financial extinction along with broadly expanding the scope of the agency, known formally as the California Institute for Regenerative Medicine (CIRM)

The agency was created in 2004 and was given $3 billion that the state borrowed. The cash is now running out. And the agency will begin closing its doors this winter without a massive infusion of money. Proposition 14 provides $5.5 billion. 

During its nearly 16 years, the agency CIRM has not yet funded research that has led to a stem cell treatment widely available to the public and approved by the federal government. 

It has helped to fund 64 clinical trials, which are a necessary prelude to commercializing a therapy. Some 30,000 patients would have to be enrolled in each of those trials to bring the "relieved-suffering" figure to two million.

The “suffering of millions” rhetoric was not the only case where the editorial echoed campaign hype. The Bee also said that the measure would cost only “$5 per person per year for 30 years,”  repeating an unsubstantiated assertion by the campaign. It may or may not be accurate, but it would involve a series of calculations and assumptions that the campaign is unwilling to share with the public. 

The California Stem Cell Report asked the campaign 53 days ago how it came up with the figure. The campaign still has not responded, which is a reasonable indication that the campaign lacks confidence in the number, to put it mildly.   

The editorial is behind a paywall. If you would like to see a copy, please email djensen@californiastemcellreport.com.

Thursday, October 22, 2020

Prop. 14 Media Coverage from Capitol Weekly and California Healthline

The campaign on behalf of a $5.5 billion stem cell ballot measure this week placed an opinion piece on Capitol Weekly, and California Healthline separately offered up a news overview of the proposal, Proposition 14. 

The measure would save the California stem cell agency from financial extinction and broadly expand its scope into new areas ranging from mental health to "aging as a pathology." The agency is running out of the $3 billion that voters provided nearly 16 years ago and will begin closing its doors this winter without a major cash infusion. 

The piece on Healthline referenced the 2004 ballot initiative that created the agency. The article by Rachel Bluth said,
"During that first campaign, voters were told research funded by the measure could lead to cures for cancer, Alzheimer’s and other devastating diseases, and that the state could reap millions in royalties from new treatments.

"Yet most of those ambitions remain unfulfilled."
The article continued,
"The campaigns for both bond measures may be giving people unrealistic expectations and false hope, said Marcy Darnovsky, executive director of the Center for Genetics and Society. 'It undermines people’s trust in science,' Darnovsky said. 'No one can promise cures, and nobody should.'

"Robert Klein, a real estate developer who wrote both ballot measures, disagrees.... He said some of (the agency's) breakthroughs are helping patients right now.'

"'What are you going to do if this doesn’t pass? Tell those people we’re sorry, but we’re not going to do this?' Klein said. 'The thought of other children needlessly dying is unbearable.'"
California Healthline is independently published by Kaiser Health News for the California Health Care Foundation.

The Capitol Weekly piece was written by Tracy Grikscheit, chief of pediatric surgery at Children’s Hospital Los Angeles, who has received nearly $15 million from the stem cell agency. Children's has received more than $32 million from the agency. It has a longstanding relationship with the University of Southern California, which has received more than $114 million from the agency and which has also had a representative on the agency's board for a number of years in the past.

The Capitol Weekly article largely consisted of well-worn information from the campaign for Proposition 14.  Capitol Weekly is an online news service covering state politics and government.

Monday, October 19, 2020

Prop. 14: Online Forum Scheduled for Wednesday on $5.5 Billion Stem Cell Ballot Measure

An online forum dealing with the $5.5 billion stem cell measure to save California's stem cell research program is scheduled for this Wednesday with a panel that includes scientists and patient advocates. 

The event is free and open to the public. It is sponsored by Summit for Stem Cell Foundation, a San Diego-based, stem cell advocacy group. The session will include a live Q&A segment. Questions may also be submitted in advance. 

On tap for the discussion about Proposition 14 are Jeanne Loring, co-founder of Aspen Neurosciences and formerly with Scripps Research Institute; patient advocates Kristin MacDonald and Katie Jackson; Melissa King, executive director of Americans for Cures, and the publisher of this blog for the last 15 years, David Jensen. Moderating will be Bernie Siegel, executive director of the nonprofit Regenerative Medicine Foundation. Siegel created and co-chaired 17 annual World Stem Cell Summits.

Registration is limited. You can register here. The event begins at 5 p.m. PDT and is scheduled to conclude at 6:15 p.m. 

(Editor's note: An earlier version of this item listed Paul Knoepfler of UC Davis as a participant on the panel. However, he has had to drop out.)

Sunday, October 18, 2020

Ballot Campaign Hype and Erosion of Trust in Science

The matter of trust came up last week in an item on the California Stem Cell Report that dealt with the Proposition 14 campaign and how hype can erode the people's faith in science.

The following comment was sent via email by a person very well-versed in science, research and human behavior who, however, must remain anonymous.

"What would be the rationale behind trusting science any more than trusting Google, a cable news network, or politician? 

"Science is the work product of scientists, who are human beings the last time I looked. Inherently interested and incentivized human beings, as we all are. 

"Sure, they often tout themselves as 'independent' or 'neutral and disinterested' parties in this business. But rest assured that is just marketing. For there is lots and lots of money at stake. Money that directly benefits and influences these neutral arbiters of truth in exactly the same way as it benefits and influences the executives at Facebook.

"I'm not criticizing, only pointing out the reality that economic forces, like gravity, apply to everyone. No profession is exempt. In that sense, science is trustworthy. Having been paid for, the outcome is both predictable and assured."

****

​A new book about the stem cell agency includes a discussion of trust and the California stem cell agency based on comments from the Institute of Medicine, which performed a $700,000 evaluation of the enterprise. Authored by David Jensen, you can buy the book on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Friday, October 16, 2020

Prop. 14 News Coverage: The 'Nuanced Track Record' of the California Stem Cell Agency



California's $3 billion stem cell agency, which is facing a life-and-death test on this fall's ballot, was described this week as chalking up a "nuanced track record" in an article carried by the online news service CalMatters. 

The article recounted the history of the agency since 2004, when it was created by a ballot initiative, Proposition 71. Today, the agency is running out of money and hopes voters will approve Proposition 14, a $5.5 billion ballot measure that also makes extensive changes in the scope of the agency. Without substantial funding, it will begin closing its doors this winter. 

CalMatters is a nonpartisan and nonprofit online news site devoted to state government and politics. The piece by Barbara Feder Ostrov said,

"This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

"Voters will want to consider what California’s previous investment in stem cell research has accomplished. It’s a nuanced track record.

"While many scientific experts agree that Prop. 71 (of 2004) was a 'bold social innovation' that successfully bolstered emerging stem cell research, some critics argue that the institute’s grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71’s supporters made years ago. Although the agency is funded with state money, it’s overseen by its own board and not by the California governor or lawmakers."

The "social innovation" comment was contained in a 2012 blue-ribbon study of the agency, commissioned by the agency itself for $700,000. The study also said that the agency has substantial built-in conflicts of interest on the governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. 

The California Stem Cell Report last month performed an analysis of CIRM awards that showed that 79 percent of the $2.7 billion in grants has gone to institutions that are linked to members of its governing board. 

Ostrov's article additionally said, 

"A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers’ initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the state’s economy."

The stem cell agency commissioned the report at a cost of $206,000.

Ostrov noted substantial opposition in editorials in California newspapers. 

"The editorial boards of some of California’s biggest newspapers...have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno BeeModesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop. 14." 

******

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Wednesday, October 14, 2020

California's Five-Buck Stem Cell Mystery and Prop. 14 Campaign Hype

The campaign to save California's stem cell agency with a $5.5 billion cash infusion is peddling a variety of claims that stretch the facts or that the campaign is unwilling to support publicly.  

Leading the pack is the assertion that the multibillion-dollar proposition will cost no more than a bottle of aspirin per person, per year. Unspecified by the campaign, however, is the number of persons and the number of years. The five-buck claim is clearly an attempt to minimize the cost of the proposal, which actually totals an estimated $7.8 billion, according to the state's legislative analyst. 

Robert Klein, leader of the Proposition 14 campaign, made the five-buck claim back in July. It has also appeared on the campaign web site. And Klein brought up the figure again this month in a radio broadcast.

"Proposition 14 will cost the state an average of less than $5 per person, per year – about the cost of a bottle of aspirin" is the way Klein put it last summer.

The California Stem Cell Report has asked the campaign several times to explain how it arrived at that figure. The first request was made 44 days ago (Sept. 1). The campaign has not responded. 

On Oct. 5, Klein brought up another number during a KQED broadcast. He said $4.1 billion was put into CIRM research in 2019 via matching funds. The state stem cell agency declined to verify that figure. A query to the campaign has not been answered. 

The campaign additionally uses a figure of 90 to describe the number of clinical trials in which the stem cell agency is involved. The agency, which is known officially as the California Institute for Regenerative Medicine (CIRM), says that it is  involved in 64.  That is a more than respectable number, more than Klein would have predicted back in 2005 when he was the first chairman of CIRM.

The campaign's justification for using the larger figure seems to be that somehow, someway, that some piece of CIRM-funded research, however tiny, has played a role in some sort of trial. By that criteria, John J. Loud could be also credited with contributing to a CIRM-backed clinical trial. He invented the ballpoint pen in 1888.  

Over the past several years, the agency, during public meetings, has been careful to limit its focus on clinical trials to those that involve meaningful financial participation, for which it deserves ample credit. (It should be noted that the number has grown as CIRM has helped to fund more trials.) 

Pushing the envelope is normal practice for ballot campaigns. It may be unrealistic to expect the stem cell campaign to behave any differently.  Winning is everything in an election campaign. As I have remarked in the past, a ballot campaign is like a war with a deadline. The losers are like so much charnel on the electoral battlefield.

That said, Proposition 14 involves the credibility of science, a matter much in the news nowadays. And backers of the stem cell initiative continue to suffer from the ill effects of the hype of the 2004 campaign, which was also led by Klein. 

The excessive and unrealized voter expectations raised by 2004 campaign are popping up this year in news stories and editorials about Proposition 14 in a way that does not improve its chances of approval, at least for some people. Of course, constant repetition of misleading or bogus information can have an impact on some voters as the country has seen on a national level. 

Art Caplan, a nationally prominent bioethicist, said in 2014

“Stem cell research seems, again and again, to go off the rails when it comes to the ethics of research.”

Caplan was speaking mainly about hyped claims involving stem cell research that could not be replicated. The general concern, however, remains alive.

In 2016, five researchers highlighted ongoing issues involving stem cell hype in a piece in the journal Science, They wrote,

"This (trend) raises the risk of harmful consequences, including misleading the public, creating unrealistic expectations, misinforming policy debates, devaluing methodical approaches to research, and driving premature or unwarranted clinical use. This is particularly important in light of mounting concern about the marketing of unproven stem cell treatments. This trend may have led to a gap between public expectations and the actual state of stem cell science and clinical development."

More recently in California, Hank Greely, director of Stanford's  Center for Law and the Biosciencesthis week was quoted in an article about Proposition 14.  He said, 

“Politics has a corrupting influence on everything — it pushes toward exaggeration." 

As for what that means for voters evaluating Proposition 14 and the claims of its backers and opponents, the ancient admonition of caveat emptor would seem to be the order of the day -- buyer beware.  That is a deeply unfortunate position for those who believe that the nation should trust science.  

(Editor's note: This is an updated and lightly edited version of an earlier version of this item.) 

****

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.



Tuesday, October 13, 2020

Deletion and Explanation

An erroneous item involving the removal of a CIRM board member appeared very briefly this afternoon on the California Stem Cell Report. It was premised on inaccurate information contained in a CIRM news release from 2012. The item was deleted minutes after we were alerted by CIRM regarding the incorrect information in its press release. 

'Hobby Horse' to 'Stunning Progress:' Two Newspapers Look at California Stem Cell Program and the $5.5 Billion Prop. 14

Does California's stem cell research program, now facing a $5.5 billion referendum, represent one person's "personal hobby horse" or does it represent "stunning progress" in developing therapies and cures?

Those are two questions embodied in two articles in major Californa newspapers this week about Proposition 14. The ballot initiative would provide the billions for the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is officially known. 

CIRM is running out of money and will begin closing its doors this winter unless Proposition 14 is approved. In addition to the $5.5 billion, the measure sets a new and expanded course for the agency, which has yet to help finance a stem cell therapy that is widely available to the public after working on the matter for nearly 16 years. 

Lisa Krieger, writing in what the San Jose Mercury News called an "analysis," related a number of  CIRM achievements, ranging from providing more than $200 million in "elegant buildings" to familiar anecdotes about patients who have been helped in clinical trials at least partially supported by CIRM. 

She said, 

“'CIRM has supported some really superb research and researchers and built a powerful infrastructure,' said Robert Cook-Deegan of the School for the Future of Innovation in Society at Arizona State University. 'In a field where there aren’t as many other sources of funding, that’s almost certainly, in the long run, a good thing.'"

"This is stunning progress..." Krieger wrote. "Still, it falls far short of Proposition 71’s breathless rhetoric from the 2004 campaign."

In the Los Angeles Times, Michael Hiltzik, a business columnist and author of "Big Science," said Proposition 14 "is a perfect example of the drawbacks of allowing a public program to turn into one individual’s personal hobby horse."

Hiltzik said, 

"In this case, the individual is Robert Klein II, a Northern California real estate developer who drafted and promoted Proposition 71 of 2004, the $3-billion initiative that created the program formally known as the California Institute of Regenerative Medicine, or CIRM, and who led the program as chairman during its formative years. Klein has contributed more than $6.6 million to the initiative campaign.

"CIRM has funded much worthy scientific research. But it has struggled since its creation with the outsized expectations that Klein’s advertising campaign for Proposition 71 engendered — namely, that the program would yield 'cures' for conditions including Parkinson’s, Alzheimer’s and diabetes."

Hiltzik's comments were part of a longer roundup of his thoughts on the ballot propositions that face California voters this month. He said he would vote with "regret" against the measure and referenced a longer piece that he wrote last December dissecting Klein's ballot measure and the issues have troubled CIRM.

In it, he said that Proposition 14 "perpetuates many of the original measure’s flaws and makes some of them worse. 

"That’s dangerous, because although the measure could fuel the stem cell program for years to come, it might also prompt a repudiation by voters sensitive to its many imperfections. Such an outcome would be tragic for California and the advanced science already supported by CIRM." 

The Los Angeles Times claims about 1.3 million readers daily. The San Jose Mercury is part of a newspaper chain that circulates its articles widely in the San Francisco Bay area.

Krieger and Hiltzik both were around for the 2004 ballot campaign that created CIRM in 2004 through Proposition 71, another ballot measure crafted by Klein. It ran only 10,000 words. Proposition 14 contains about 17,000 words.

I should note that Proposition 14 is technically not a ballot referendum but a ballot initiative. However, the measure effectively serves as a referendum on CIRM's past and likely future performance.

*****

To read more on CIRM, its performance and Proposition 14, see David Jensen's news book: California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Monday, October 12, 2020

Stem Cell Scientist Jeanne Loring on hESC Research, Proposition 14 and California Stem Cell Agency

(Editor's Note: The following commentary concerning the California Institute for Regenerative Medicine (CIRM) and Proposition 14 was submitted to the California Stem Cell Report by Jeanne Loring, professor emeritus from the Scripps Research Institute and co-founder of Aspen Neuroscience, Inc., of San Diego.)

By Jeanne Loring

"Long ago, when Bob (Klein) and Jeff (Sheehy) were both CIRM’s oversight board members, their arguments were legend. I was at the meetings for most of them.

"After listening to the broadcast (KQED’s Forum), I want to make 3 points:

"I want to once more correct the idea that George Bush banned embryonic stem cell research; he did not, and I was disappointed that KQED perpetuated that misconception.

"In 2004 when Prop. 71 was on the ballot, I was already receiving funding from the NIH for human embryonic stem cell research. Bush’s decision was NOT to ban hESC research, but was in fact the opposite. He decreed that hESC research could receive NIH funding for the first time. In effect, he REVERSED A BAN. On the 9th of August 2001, a group of us who had already made hESC lines with private funding became eligible, for the first time, to receive NIH funding. Article: Stem cell research gets federal OK, Aug. 9, 2001.

"In 2004 when voters were approving Proposition 71, there were NIH grants funded for Jamie Thomson in Wisconsin, for Bresagen in Georgia, for several groups in other countries, and for Roger Pederson (UCSF) and me in California. Here’s an announcement from UCSF on September 17, 2002: UCSF begins distributing the first of its two embryonic stem cell lines.

"I supported Prop 71 not because it was necessary, but because it would make California an embryonic stem cell research juggernaut. I believed in the potential of embryonic stem cells and CIRM gave me the opportunity to prove it.

"Bob Klein and I used to talk often, and I admire him for his persistence in getting CIRM established. But as time passed, he seemed to tire of my opinions. Last year I published an opinion piece in Nature that pointed out the unanticipated parallel growth of legitimate stem cell research and charlatan “stem cell” clinics: World View Nature. I immediately received this message from Americans for Cures (Bob Klein’s organization).
'Dear Jeanne,

'On behalf of the organization, I must let you know the following. 
'Unfortunately, Americans for Cures must remove you from its Scientific Advisory Board, effective immediately. Your views in the recent article in Nature are not consistent with the views of Americans for Cures as to CIRM and the importance of CIRM’s accomplishments.'
""I have mixed feelings about Prop. 14. I have benefited greatly from CIRM funding, and after many years of CIRM funding, I was able to attract private venture funding to launch a company developing a cell replacement therapy for Parkinson’s disease.

"'But I agree with Jeff Sheehy that the current measure does not fix the flaws in Prop 71. Having watched the process of approving grants by the oversight board (ICOC) for 13 years, I came to the conclusion that because the Board was made up largely of members representing institutions that were competing for grants, bias was unavoidable, and the large size of the Board, 29 members, was a detriment. The current proposition, Prop. 14, makes the situation worse by increasing the number of board members to 35 and not fixing the conflicts.

"There is a moment at which one’s trust in an organization is dashed. For me this it was this event: the president of CIRM was hosted by a professor at Stanford for at least 2 luxurious fishing trips in Montana and Alaska. This president then argued strongly in favor of large grants to Stanford, and also grants to a company that that same Stanford professor had founded. Finally, when the president stepped down from CIRM he waited less than a week before taking a paid position on the board of the company that he supported for CIRM funding. It was then that the full impact of the intrinsic bias became real to me."

(Editor's note: The reference to the president of CIRM is to its former president Alan Trounson. The reference to the Stanford University professor is to Irv Weissman.)

Sunday, October 11, 2020

Proposition 14 Campaign Coverage: George Bush, 'Blatant Giveaway' and $5.5 Billion More

Northern California's respected KQED news site has aired an overview of Proposition 14, the far-reaching, $5.5 billion measure to continue funding of stem cell research by the state of California.

The piece by Danielle Venton covers a bit of the history of the state stem cell agency, the "debt" it owes to former President George Bush and the progress of the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Venton wrote,
"The pace of innovation has been slower than many hoped. As it turned out, grand discoveries were not around the corner, and to date there is no widespread stem cell treatment approved for the public. To date, CIRM has funded more than 64 trials directly and aided in 31 more. Not all have or will result in treatments.

"But despite the lack of a marquee cure like one for Alzheimer’s or Parkinson’s, the agency has seen some notable triumphs."
Quoted by Venton were Jeff Sheehy, a member of the CIRM governing board; Melissa King, field operations manager for the campaign and executive director of the nonprofit Americans for Cures, and David Jensen, author of "California's Great Stem Cell Experiment" and publisher of this blog.

Proposition 14 would save CIRM from financial extinction. It is slated to begin closing its doors this winter as its original $3 billion in funding is running out. The agency was created by Proposition 71 of 2004, which raised high expectations of cures.  Venton wrote,
"Right now the state still owes about $1 billion toward the debt created by Proposition 71. If Proposition 14 passes, the yearly price tag to pay off the new bond would be about $260 million per year for about 30 years.

"Funding needs for stem cell research also are not as acute as they were back in 2004. The federal National Institutes of Health now funds some basic stem cell research, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research. And private ventures, like nonprofits started by tech billionaires, are pouring more money into biotech."
Venton wrote,
"Proposition 14 makes it impossible for the state to use profits from its investment on, say, schools or other funding priorities. Instead, any royalties earned must be fed back into programs to make CIRM-funded treatments more affordable. 
"'What it does is it basically takes all of our returns that we get from this and gives it back to the pharmaceutical and biotech companies,' said Sheehy. 'It becomes just a blatant giveaway to these companies when we should be requiring access and requiring fair pricing.'"
King said that "CIRM fills a neglected funding need," Venton wrote.

"'The NIH (federal funding agency) does not fund clinical trials at nearly the rate that CIRM can and has been,' King said.

"She says that's important because of what she calls the 'Valley of Death,' where promising early-stage research frequently fails to translate into promising treatments that can be tested in clinical-stage research. (What works well in a test tube often does not work well in an organism.) This weeding-out process is costly but necessary. And it’s where CIRM focused a lot of its effort."

Saturday, October 10, 2020

LA Times Runs Down the Middle in News Report on $5.5 Billion Stem Cell Ballot Initiative

California's largest circulation newspaper, the Los Angeles Times, this week published an overview of the state's $5.5 billion stem cell ballot measure that was headlined:

"With Prop. 14, California voters will be asked for more borrowing to keep stem cell research going"

The article by Melody Gutierrez played the issues pretty much down the middle. However, backers of the measure, Proposition 14, likely are not happy with the headline. They would have preferred one that focused on how they think the measure would save lives. 

The ballot initiative is aimed at refinancing the state stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM) and which will be closing its doors this winter because it is running out of money. The measure would also substantially widen CIRM's scope

The Times piece article carries more weight than most news pieces on the proposal because of the Times' reach and reputation. The newspaper claims a daily readership of 1.3 million and a combined print and online local weekly audience of 4.6 million.

The article said,
"Proposition 14 has no organized opposition and, so far, no one willing to put their money into fighting it — but the measure does have critics. Newspaper editorial boards, including those at the Los Angeles Times and San Francisco Chronicle, have opposed it. Opponents include CIRM board member Jeff Sheehy, who says the state shouldn’t take on new debt while facing a pandemic-induced deficit and that medical advances attributed to the previous stem cell bond have been overstated."
The Times piece captured a bit of stem cell history:
"The campaign to pass the 2004 ballot measure told voters that the bond would save millions of lives and cut healthcare costs by billions. Critics say that’s not been the case to date, although supporters of this year’s measure note that they never intended those results within 16 years."
It should be noted that the "never intended" remark from Klein's campaign reflects a rewrite of history. The 2004 campaign was much criticized for its hype and raising voter expectations that stem cell cures were right around the corner.

Gutierrez also touched on the problem of finding financing at risky stages of research, writing,
"Alzheimer’s disease researcher Dr. Larry Goldstein, who works at UC San Diego, said the state’s stem cell agency fills a void in critical grant funding. He said industry, venture capital and federal funding is available, but often goes toward research showing promising results in late-stage trials. He said money is needed, however, to move a scientific discovery to that point. That gap, which he said is referred to as the “valley of death” in research, has been filled by CIRM grants.

"'It was getting more and more difficult to fund novel, risky and creative scientific projects,' Goldstein said. 'CIRM has done a good job of funding parts of my research that were particularly risky that have led to a particular payoff.'"

 The Times also reported,

"Sheehy said he’s been dismayed by claims now being made by proponents of Proposition 14 that he said mischaracterize some achievements as being the direct result of CIRM funding when the agency’s role was limited. If a major drug was developed with CIRM’s funding, the state would receive a royalty, patent or licensing revenue. To date, the agency has received $462,433, a fraction of what voters were told the state would take in."

Gutierrez concluded, 

'"The state can’t just keep giving money to this forever,' Sheehy said. 'It was never meant to be a permanent thing. It was for a specific unmet need that doesn’t exist anymore.'"

********

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Friday, October 09, 2020

Head of Prop. 14 Stem Cell Campaign Schedules Internet Appearance for Tomorrow

The leader of the campaign to approve $5.5 billion for stem cell research in California is scheduled to appear on an Internet broadcast tomorrow during which he will deliver what the campaign calls an "important" and "special" message. 

The announcement of the appearance of Robert Klein came on short notice this afternoon. Klein, a Palo Alto real estate developer, not only heads the campaign but sponsored Proposition 14, the 17,000-word initiative that would greatly expand the scope of the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is officially known. 

The agency was created in 2004 through another ballot initiative, also sponsored by Klein, who became its first chairman under the terms of that stem cell initiative.  The $3 billion provided by the 2004 measure is all but gone, and the stem cell agency will begin closing its doors this winter without more cash. 

The announcement of the campaign event, which involves the campaign's student ambassadors, was made this afternoon by Melissa King, director of field operations for the campaign. King is also executive director of the nonprofit Americans for Cures, a stem cell advocacy group founded by Klein. 

King made the announcement in an email message to campaign supporters. She said  Klein would appear during the last half hour of a one-hour webinar at 12:30 p.m. tomorrow (Oct. 10) at 12:30 p.m. PDT.  Here is the Zoom link to join: https://us02web.zoom.us/j/89031672494

Thursday, October 08, 2020

Tangling Over $5.5 Billion Stem Cell Measure: CIRM Board Member vs. its Former Chairman

Robert Klein is on the left, Jeff Sheehy on right at CIRM
directors meeting. Art Torres, vice chair of the board is in
the middle. CSCR photo

The two men once worked together over the last 16 years to spend $3 billion in state funds on stem cell research in California. This week, however, they were very publicly on opposite sides of a ballot initiative to spend $5.5 billion more. 

The initiative is Proposition 14, which would require the state to borrow the additional billions. The measure would also substantially expand the scope of the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM).  

Both men, Robert Klein and Jeff Sheehy, served on the CIRM board, regularly approving hundreds of millions of dollars in research awards annually. Klein is a Palo Alto real estate developer and was the first chairman of the agency. He directed the writing of Proposition 14 and now heads the campaign.  He left his post as chairman in 2011.

Sheehy continues to serve on the CIRM board and has since 2004. He is a patient advocate member of the board, its former Science Subcommittee chair and a nationally recognized HIV/AIDs advocate. Sheehy was the lone dissenting vote when the CIRM board endorsed Proposition 14 in June, although he says the agency has done "tremendous" work.

They came together "remotely" when they participated Oct. 5 in a public radio show, KQED's Forum with Michael Krasny, that is heard throughout California on public radio stations. 

Klein and Sheehy bristled at times during the 38-minute broadcast. Klein said figures presented by Sheehy were "completely false." Sheehy said Klein's financing mechanism in Proposition 14 was "very dodgy" and "ridiculous." 

In the initial years of financing, Sheehy said, "It's like getting a credit card and then getting another credit card to carry the interest (from the first credit card)."

Longstanding issues were also raised concerning conflicts of interest on the CIRM board and other deficiencies identified in an evaluation of CIRM by the prestigious Institute of Medicine (IOM). The 2012 study was commissioned by CIRM itself at a cost of $700,000. Both Klein and Sheehy supported funding the study as a way to secure what they thought would be a gold standard endorsement of the agency. 

Klein's initiative does little to deal with the issues raised by the study, which said "inherent conflicts of interest" exist on the board. The report also recommended that the 29-member board be overhauled completely and not expanded.  Proposition 14 would increase the board size to 35, however, increasing conflicts of interest. The measure also does not address the management and governance problems cited by the study.

An analysis last month by the California Stem Cell Report showed that 79 percent of the awards approved by the CIRM board went to institutions that had links to board members even though the "institutional" members are not permitted to vote on awards to their institutions. Conflicts of interest have been so pervasive at times that only six or seven members were allowed to vote on awards. 

Sheehy and Klein also talked briefly about state spending priorities in the Covid year and the state's ongoing affordable housing, education and homeless problems. Overall, the KQED program provided only a tiny peek at the issues involved in Proposition 14. 

Klein's position can be fully explored on his campaign's web site. Over the last 12 months, Sheehy has aired his position at CIRM board meetings and in submissions to the California Stem Cell Report. Here is what Sheehy wrote regarding his no vote on endorsement of the ballot measure.

A detailed look at the findings of the IOM report and the current status of CIRM's response is contained in the new book "California's Great Stem Cell Experiment: An Inside Look at a $3 Billion Search for Cures."  The book was written by the publisher of this blog and grew out of more than 15 years of close observation of the stem cell agency. 

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