Showing posts sorted by relevance for query george bush. Sort by date Show all posts
Showing posts sorted by relevance for query george bush. Sort by date Show all posts

Thursday, November 05, 2015

George Bush, the California Stem Cell Agency and the Daily Beast: A Story for 20 Million Readers

The Daily Beast this morning carried a story with the headline “George W., Father of the Stem Cell Revolution.”

If that gives you pause, consider the Daily Beast’s next two paragraphs.
“It wasn’t what President George W. Bush had in mind. In 2001, Bush restricted the use of federal funding for embryonic stem cell research, giving conservatives what looked like a major victory in the nation’s culture wars.
“Three years later California thumbed its nose at the ban by starting its own multi-billion dollar stem cell program, and several states followed suit. Even though the restrictions were lifted in 2009, the insurgent movement survived and grew.”
The article was authored by Guy Gugliotta, who writes on science and public policy. The piece appeared both on the Daily Beast, which claims more than 20 million readers a month, and Kaiser Healthline, which is also carried on the Daily Beast. The article offers a lesson in unintended consequences for those who thought the federal restrictions would crush research using human embryonic stem cells. Gugliotta said,
“Today at least seven states offer stem cell research funding or other incentives to local scientists and industry.” 
The article covered the scene in states across the country, but dealt in more detail with the $3 billion California stem cell agency. Quoted was Randy Mills, president of the agency, as well as yours truly. Gugliotta wrote,
“’Without George Bush, this agency would not exist,’ said David Jensen, publisher of California Stem Cell Report, a blog focused on the California institute.” 
Bush’s restrictions created the justification for California to march -- on its own -- into the wilderness of stem cell research 11 years ago this month. Absent Bush's actions, there would have been virtually no perceived need for the state to embark independently.  

Gugliotta recounted the history of the agency and summarized the issues that have come up since 2004. He wrote,
C. Randal Mills, chosen in 2014 as the institute’s new president and chief executive officer, said the organization is adjusting to ‘a world that has changed significantly’ since 2004 by moving away from simply funding good ideas in isolation to what he describes as a ‘system-based agency.’
“Last year the institute had 10 programs in clinical trials, but expects to have 20 by the end of this year.
“'We’re setting up continuous paths to move basic research to clinical trials,’ he added. ‘It’s like a train moving down a track, where each grant is the link to the next step down the line.’” 
Noting that President Obama has lifted the Bush restrictions, Gugliotta concluded,
“Despite the improved national (stem cell research) climate, states, both for economic and scientific reasons, have continued to fund their own programs. NIH lists initiatives in six states, not counting Minnesota, and other reports have suggested that as many as 15 states either have dedicated programs or fund stem cell research or did so in the past.
“Yet in a discipline that is just beginning to enter a translational phase, it is hard to evaluate the effectiveness of individual programs: ‘It’s a huge field, and it’s still early,’ said Heather Rooke, scientific director for the International Society for Stem Cell Research. “States will continue to do basic research, and California has certainly already had important influence driving the research to the clinic.’
“Results will take time, agreed Minnesota’s (Jakub) Tolar, but it is worth the trouble: ‘We started on drugs a hundred years ago. Then we went to monoclonal antibodies—biologicals,’ he said. ‘We are now getting ready to use cells as a third way of doing medicine. We are at a historical sweet spot.’”

Sunday, February 13, 2011

Has CIRM Funded Stem Cell Research that Bush Would Have Banned?

When California voters approved creation of an unprecedented, $3 billion stem cell research program more than six years ago, they were told the money would go to finance research that then-President George Bush had banned.

Has that actually happened? Yes, but mainly no, according to a research paper published in Nature Biotechnology in December 2010.

In the first-ever such analysis of CIRM grants, Aaron Levine, assistant professor in the School of Public Policy at Georgia Tech, reported that through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding.

Levine's finding has implications for another, multibillion-dollar bond ballot measure that CIRM Chairman Robert Klein has proposed. The campaign for such a measure would have to address the question of whether the promises of the 2004 ballot initiative that created CIRM have been fulfilled.

CIRM does not offer on its web site figures that can be compared to Levine's calculations. The agency does present some statistics about the amount of funding for embryonic stem cell research, but makes no effort to break out the percentage of grants that would not have received funding during the Bush years.

Levine's numbers on California were part of a broader look at state funding of stem cell research in recent years. He reported that by the end of 2009, six states had awarded nearly 750 grants totalling $1.25 billion. California accounted for $1 billion of the total. Per capita funding amounted to about $1 in Illinois and nearly $28 in California.

In all of the states, percentages were low for research that was clearly ineligible for federal cash under the Bush standards. Levine wrote,
"Most state hESC funding appears to have supported research also eligible for federal funding during the Bush Administration. This finding is surprising, given the explicit intent of several state programs to preferentially support science not eligible for federal funding, but likely reflects the nature of the grant proposals state agencies received, particularly given the number of grants states awarded to scientists relatively new to the field of hESC research.
Levine continued,
"Several factors could explain the relatively small share of grants that went toward clearly ineligible research. Some scientists who wished to pursue this research may have been unable to access the raw materials or acquire the intellectual property rights required to do so. Alternatively, these findings could simply reflect scientific interest. The discovery of induced pluripotent stem cells may, for instance, have reduced scientific interest in the derivation of new hESC lines. Finally, these findings may reflect a preference on the part of scientists to use well-established and well-studied hESC lines. This last explanation may be particularly relevant for new scientists entering the field of hESC research, as using recognized cell lines may give their initial research efforts greater credibility."
In California, another factor enters into funding for Bush-banned research, particularly given the 2004 campaign promises. CIRM makes overt decisions about what to fund. Its RFAs spell out what is acceptable and non-acceptable. The agency could have specified that it would not fund any research that would be eligible for federal funding. But whether that would have been "good science" is another question. CIRM also spent nearly $271 million on new labs at many of its directors' research institutions, diluting the percentage that would be construed as financing Bush-banned research.

We are querying CIRM concerning Levine's statistics.

Levine also reported that the state stem cell research efforts appear to have drawn new scientists into the field, with the largest impact occuring in California. He wrote that 42 percent of those funded in this state appeared to be fresh to the field.

In addition to the Nature Biotechnology piece, Levine has created an online database of state grants that he plans to update regularly. In an email to the California Stem Cell Report, he said,
"While CIRM already makes this information readily accessible, some of the other state programs do not and I hope this database will facilitate comparisons among the various programs and prove to be a useful tool for people interested in state stem cell programs. "

Sunday, November 27, 2011

The CIRM 'Debt' to George Bush and Disgraced Korean Researcher

It was brief but pointed comment on the differences in the stem cell world of 2004 compared to the stem cell world of 2011.

Larry Ebert, a patent attorney, made the remark on his blog, IPBiz. He was writing about an observation on this website that without George Bush and his restrictions on federal hESC research, there would have been no California stem cell agency.

Ebert said,
"IPBiz notes that when the California voters voted Prop. 71 in, scientists thought Huang Woo Suk's work on hESC was real. In 2011, the current state of the art is still not up to what Huang Woo Suk falsely reported in the journal Science. Californiastemcellreport should give Huang Woo Suk some credit for the passage of Prop. 71."

Consider Woo Suk duly credited.

Wednesday, November 09, 2016

Trump: Helpmate to the $3 Billion California Stem Cell Agency?

Donald Trump's victory last night, oddly enough, could be good news for the future of the California stem cell agency. 

It could be George Bush all over again.

How does that work, you may ask? Trump is a bit of a blank slate on stem cell issues. He has not addressed them directly. But he is pro-life, a fact being celebrated this morning in the usual pro-life venues.

Given that stance, he is likely to reverse the federal government's current funding of human embryonic stem cell research. It would be easy to do, basically nothing more repealing an executive order or issuing a new one.

Such a move would echo the Bush restrictions on human embryonic stem cell research that provided the justification for the 2004 ballot initiative that created California's $3 billion stem cell research effort. Bush's opposition energized the scientific and patient communities on behalf of the initiative.

His opposition also helped to raise the $34 million for the electoral campaign that spawned the California Institute for Regenerative Medicine (CIRM), the official name of the stem cell agency.

Bush provided a big target for supporters of stem cell research. (See here and here.) He embodied the essence of the "anti-science" crowd. And in politics it is good to have a "demon" that can easily be understood. It simplifies issues, sharpens the focus and stimulates voters.

The stem cell agency is now on track to run out of money in 2020 for new awards. CIRM relies on state bonds for its cash but its ability to issue them is coming to an end. No additional source of funding has been identified.

Assuming Trump bans federal research on human embryonic stem cell research, it would bring new life to the possibility of another multi-billion dollar bond issue in the next few years. A new "demon" would surface. All the agency needs to do now is to come up with a high-impact therapy that would resonate with California voters.

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."

Tuesday, February 24, 2009

What Bob Klein and CIRM Owe George Bush

Here is what Hank Campbell, the major domo of scientificblogging.com, says,
 "Whether you agreed with Bush or not, his restrictions on stem cell research were good for science - California alone threw $3 billion at human embryonic stem cell (hESC) research for no other reason than that Bush was against it, something that could never have occurred through the NIH, and scientists also found creative alternatives, also something that would probably not have happened."

Wednesday, August 15, 2007

Giving Bush The Treatment

Stanford's Chris Scott looks at how George Bush might encounter stem cell therapy some years down the road in a case involving the famed "Jenna" line of stem cells. You can read it here on Scott's blog, The Stem Cell Blog.

Wednesday, September 10, 2014

California Bets $55 Million on 'Teabag' Diabetes Treatment

BERKELEY, Ca. -- California today beefed up its investment in a “teabag” therapy for diabetes, bringing the total to $55 million in an effort to develop a “virtual cure” for an affliction that affects 347 million people worldwide.

It is believed to be the largest direct investment that the state has ever made in a company. The therapy also involves the most controversial of stem cell treatments, ones derived from human embryonic stem cells(hESC). 

The impact of the potential therapy could be far-reaching.  About 70,000 persons die each year in this country from diabetes. It is the 7th leading cause of death in the United States.

Forty-three-year-old Maria Torres, who lives in the Sacramento area, is hoping for a positive outcome on the therapy.
Maria Torres
CIRM photo
 “I have three kids, and I know they could have the same thing I have. If they find a cure, for me, that’s peace of mind.”
Torres was featured in a blog post yesterday by the California Institute of Regenerative Medicine(CIRM), the state’s nearly 10-year-old, $3 billion stem cell research program, which is providing the taxpayer funding.

Meeting here today, directors of the agency approved, on an 8-0-1 vote, $16.6 million in awards to Viacycte, Inc., of San Diego, Ca., to advance its work on the therapy.  Over the last six years, the agency has pumped $38.5 million into the company, which has received by far the greatest amount of cash from the agency of any business. A subsidiary of Johnson&Johnson as well recently invested $20 million in Viacyte.

The firm’s treatment is scheduled to begin clinical trials this year. UC San Diego has begun enrolling patients, Viacyte CEO Paul Laikind told CIRM directors this morning.

The therapy involves several, porous, teabag-like packages that are inserted beneath the skin. An individual device is about the length of a credit card but half the width. The firm plans to work on a larger device for single insertion. 

In the CIRM blog post yesterday, Anne Holden, Web content and social media manager for the agency, said the device contains cells that “sense blood sugar levels and produce insulin to reduce them.”  That “allows transfer of blood sugar, insulin, oxygen, and other molecules but keeps (other) cells out, thus avoiding the possible attack and rejection by the patient’s own immune system.”

Regular use of the treatment is years away because of the series of clinical trials that must be run. Additionally, only about one out 10 traditional drugs entering clinical trials reach the marketplace. No therapies involving human embryonic stem cells (hESC) have successfully run the clinical trial gauntlet in the U.S. and secured approval for widespread use.  

Viacyte’s therapy is derived from those controversial cells and is the first hESC trial backed by CIRM.   Some religious groups and others believe the use of the cells is tantamount to murder. Opposition to hESC research has subsided in recent years because of the focus on the possible use of reprogrammed adult stem cells. However, it flared up again in recent weeks because of a flap over the so-called Ice Bucket Challenge, which raised funds for ALS research, some of which involves hESC.

The California stem cell agency, ironically, owes its existence to the opposition to hESC research. Former President George Bush restricted federal funding for hESC research because of the religious concerns. The ballot campaign in 2004 to create the agency relied heavily on Bush’s action to demonstrate the need for continuing research into the promising field. 

Here is a link to the CIRM press release on the awards. 

Wednesday, November 23, 2011

California Stem Cell Agency Takes Initiative in PR 'War'

Jonathan Thomas, chairman of the $3 billion California stem cell agency, took to the blogosphere today with an item promoting CIRM's progress, declaring that it is a record of which Californians can be proud.

In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,
"Given that it normally takes a decade or longer for a basic science discovery to reach clinical trials, 43 projects seemed to me like quite an achievement – an achievement that the people of California should take pride in supporting. Not only is CIRM driving stem cell science in our state, but through our national and international collaborations California has become a stem cell hub that accelerates stem cell progress worldwide."
Thomas, a Los Angeles bond financier, pointed to a new document from CIRM, titled "Funding therapies: Fueling Hope." It summarizes some of the agency's work and touts the "incredible potential" of stem cells.

The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,
"Altogether, carrying out the basic research, translational work and preclinical data leading up to a clinical trial can take a decade or longer, and that's just to start the clinical trial. CIRM’s funding approach speeds that timeline by providing stable funding that eliminates pauses in the research to raise new funds, by strategically funding areas thought to be barriers to the clinic and by forming teams of researchers who work in parallel rather than sequentially to reach clinical trials faster."
When Thomas was elected chairman of the agency last June, he told directors that the agency was in a "communications war" in which its record was not fully appreciated by the public. He made telling the CIRM story one of his top priorities.

Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.

The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency  since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.

Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.

Sunday, March 11, 2007

Two Days of Stem Cells: Founder Flight to Hyperventilation

Christopher Thomas Scott, executive director of Stanford's Program on Stem Cells in Society, is scheduled to set the scene Monday for a two-day international conference on stem cells in San Francisco.

"The business issues are profound," he says, "including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against 'founder flight' as entrepreneurs seek permissive jurisdictions to launch their businesses."

We asked Scott, who is co-chair of the conference sponsored by Burrill & Company, for a preview of his remarks. Here is what he supplied.

"No one can deny the promise of regenerative medicine. But the field has its shaky spots: an astonishingly young science, polarized politics, and fraught with ethical worry. Yet stem cell biology has been on a tear lately. In just a handful of years, the science has moved from hunting stem cells to the arcane secrets of signal transduction. The hyperventilation about which stem cells--embryonic or adult--will be clinically useful is largely lost on scientists. The questions facing them are more elemental: can stem cells be chemically reprogrammed to earlier, more powerful versions of themselves? On which branch of the family tree does a new stem cell rest? What gene signals cause a stem cell to make more stem cells, or change into the next cell type down the line? The last question is on every researcher’s mind, because signal pathways are critical to understand how a certain type of cell can be made from an embryonic stem cell line, or how millions of adult stem cells can be made from a just a few to treat disease.

"2006 was a watershed year in other ways. Most Americans support embryonic stem cell research, and so does Congress. Despite a vote in the House and Senate that would overturn a restrictive presidential mandate, it wasn't enough to override George Bush's first-ever veto. California pushed through a thicket of lawsuits to shake loose billions of dollars for regenerative medicine. Now, finally, there is light at the end of that tunnel. Legislation in other states is moving so quickly it's difficult to keep track: just last week, Illinois, Iowa, Minnesota signed laws to permit all types of stem cell research. As political winds fanned the flames stateside, stem cells went international, creating a different kind of global warming. In a mighty push, Australia overturned a ban on nuclear transfer. The world's researchers had a banner year, with Japan, Germany, Norway and others announcing major discoveries. Not all the offshore news was good, however. The heat created a conflagration with the biggest scientific fraud in memory, the South Korean scandal.

"One thing is certain--international politics and the legal landscape has altered the way we do biomedical research. Thomas Friedman's "global flattening" doesn't apply here. A mosaic of legislation and national policy means uneven terrain for funding, infrastructure and accessibility to embryos and lines. The business issues are profound, including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against "founder flight" as entrepreneurs seek permissive jurisdictions to launch their businesses. The vacuum in Washington has shattered the state legislative landscape. In one state, a scientist can go to jail for doing embryonic stem cell research. In another, embryos can't be used for research, but it is fine to ship them in across the border. And who would have predicted this in 2001, the year of Bush's pronouncement: once funding from California, Wisconsin, New Jersey, Connecticut, Illinois, Maryland, Massachusetts, and other states is fully unleashed, it will surpass by a wide margin any dedicated federal dollars, restricted or otherwise.

"With all the moving parts, it made sense to assemble a group of experts and scholars from many disciplines to address issues at the interface of science, business, economics, law, and policy. I was delighted when Burrill & Company asked me to develop an agenda that would explore these connections. As a rule, stem cell conferences tend to be monolithic, in part because the reach of regenerative medicine is too broad to be addressed in two or three days. But to my knowledge, no conference tackles these questions from an international perspective. I'm excited to learn what this stellar group has to say, and how the glimmering edge of biology's most promising frontier will look in 2007 and beyond."

We will attending the conference both days. Watch for continuing coverage of the event.

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.)

Thursday, February 05, 2009

Waiting for Obama -- The Stem Cell Delay

Wondering what Obama is wating for? When will he revoke George Bush's rules on human embryonic stem cell research?

It might be in a few weeks or perhaps even much longer, based on a story in the Philadelphia Inquirer.

Reporter Marie McCullough wrote earlier this week,
"Rep. Mike Castle (R., Del.), a congressional champion of the research, said that last week, he explicitly asked White House officials about it.

"'I believe there will be an executive order lifting the funding ban,' Castle said. 'My speculation is that it will happen in a few weeks. . . . They've had a lot of things to deal with. I see no bump in the road.'"
She continued,
"Not until four days before the inauguration, during a CNN interview, did Obama say he would 'prefer' that Congress pass legislation removing Bush's restrictions, 'because those are the people's representatives.'

"That comment prompted some patients' groups to gripe that Obama was backpedaling on his campaign promise.

"But leading scientists also believe that research policy is better set by a comprehensive law than by a revocable directive.

"'I would agree with that,' said John Gearhart, a stem-cell-research pioneer who was wooed last year from Johns Hopkins University to the University of Pennsylvania. 'As researchers, we need a stable base.'"
Legislation can require many months, if not longer, to work its way through Congress, depending on other competing priorities, of which there are many, in Washington.

Monday, August 07, 2006

Reflections on Stem Cells: Year Five

There are anniversaries and then there ARE anniversaries. In this case, Wednesday is the fifth year anniversary of George Bush's stem cell edict.

Stanford University is marking the occasion with reflections from its cadre of stem cell whizzes, including Irving Weissman, Philip Pizzo, Stefan Heller and David Magnus.

Here are some excerpts.

On the question of what would have been different if the president had remained silent:
"David Magnus, PhD, director of the Stanford Center for Biomedical Ethics: We would have had national standards and guidelines much sooner, and we would not have been distracted by debates over the status of embryos and embryo-like constructs. We would have had to work much faster to figure out how to handle informed consent and other practical ethical challenges."

On the most significant thing learned in the past five years:
"Stefan Heller, PhD, associate professor of otolaryngology, who is investigating the use of stem cells to repair hearing damage: The past five years were key in redefining possible new approaches to find a cure for hearing loss, and stem cells played a big role in this process. We experienced the advent of stem cell-based regenerative approaches for the inner ear."
"Philip Pizzo, MD, dean of the Stanford School of Medicine and a member of the Independent Citizens' Oversight Committee for the state's stem cell institute: One of the important transitions in the past five years has been the increasing proportion of Americans who have become supportive of embryonic stem cell research. Their voice reflects a gap between the Bush administration's tenacious fixation on religious ideology and America's common-sense perspective about the value of medical research in improving the lives of adults and children. This is coupled with an increasing number of American citizens who have stepped forward to support embryonic stem cell research through philanthropy along with a rising choir of bipartisan support from the Congress. In addition, a number of states have demonstrated their support for stem cell research through either state-funded research programs or legislative activities."
The most important thing to learn in the next five years:
Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine. "We will continue pushing forward on four stem cell fronts: 1) Learning how to regenerate diseased tissues using adult tissue stem cells; 2) Finding new and useful embryonic stem cell lines and the tissue stem cells they make, such as the heart and lung; 3) Finding safe, ethical ways of making stem cell lines from patients with genetic diseases that help us understand and treat those diseases; 4) Finding new therapies based on our cancer stem cell research and using our discoveries to treat Stanford cancer patients."

Tuesday, January 14, 2014

Nine Years on the California Stem Trail: A Look Behind the Curtain

Back in November 2004, the re-election of President George Bush dominated the news throughout the nation. But out in California, there was talk of a new gold rush, triggered by a measure buried deep on the ballot that month.

The latter-day argonauts were not expected, however, to be scratching out nuggets. Instead they would be fiddling with stem cells, particularly human embryonic stem cells. It all looked like big bucks for the biotech industry -- $3 billion from a new state agency.

That was when the idea for this blog began to percolate. A few weeks later -- nine years ago this month  -- the first item appeared on the California Stem Cell Report. It now seems a likely occasion to reflect on the scope and purpose of what appears here and to discuss readership and other matters.

David Jensen
Editor California Stem Cell Report
First, to answer an oft-heard question: Why am I am writing about this particular agency, formally known as the California Institute for Regenerative Medicine(CIRM)? The simple answer is that it is interesting, at least to some, and important. The agency – created by Proposition 71 of 2004 – is an exceptional and unprecedented state effort. Nothing like it has existed in
California history. It operates with unusual autonomy. The governor and the legislature cannot touch its funding or direct its research. It survives on $3 billion borrowed by the state, which will roughly double the cost of the research to $6 billion or so because of the interest on the borrowing. It also marks another first with its use of California state debt to pay for scientific research.

At one point, CIRM was the world's largest single source of funding for human embryonic stem cell research. The agency has lured top researchers from other states and countries. And it represents a unique mash-up of government, politics, big business, big science, big academia, morality, ethics, life and death and even sex.

Since 2005, the California Stem Cell Report has been read by researchers, policy makers and other interested parties around the world. They log in from Singapore and Great Britain, Canada and Korea as well as institutions ranging from the NIH and Harvard to Stanford, UC San Francisco, Scripps and Sanford Burnham and more.

I estimate that only a few thousand persons around the world are deeply interested on a regular basis in stem cell research, making the potential audience for this Web site rather small. But Google reports that as of today 729,841 page views have been registered during the life of the blog. (I have posted 3,608 items.) Last month, which was slow because of the holiday, the California Stem Cell Report chalked up 16,878 page views, which are the basic Internet standard for measuring readership.

The items that seem to grab the most attention involve individuals as opposed to the nuts and bolts of either science or policy. When CIRM directors considered election of a new chairman in 2011, readership jumped. Machinations involving selection of new presidents at the agency draw readers. Of course, reports about dubious activities or problems also are of significant interest. The lure of stories about people nonetheless is not much different than seen in the mainstream media, based on my 35 or so years in the news business.

Another matter that has drawn an extraordinary amount of interest involves money: specifically the expected cost of stem cell therapies. In 2010, I posted on Scribd a study financed by CIRM -- one that the agency was not trumpeting -- that examined the issue of costs. Since then, it has been read 14,096 times, the most of any document that I have posted on the Scribd service, which provides a way to mount documents and link to them via the blog.

In its initial years, the blog primarily surveyed California media reporting on the stem cell agency, providing links and commentary with some original reporting. But today the focus is mostly on original reporting with analysis and commentary. The agency and its doings have slipped off the radar of the mainstream media, where they probably will remain short of a major scandal or a massive PR effort by the agency.

One of my goals was to provide detailed information, news and analysis about California's unusual research effort – far more than could be done by print media. The idea was to exploit one of the unique characteristics of the Internet-- the capability of publishing nearly unlimited amounts of information. Newspapers constantly cut, squeeze and trim stories because of both cost and their desire to publish a large number of articles about many different subjects. With the Internet, there is virtually no limit on the amount of content, a feature that is both good and not-so-good. Another goal was to go beyond the official handouts and to provide a guide to where useful information can be found.

The California Stem Cell Report differs from the mainstream media in another regard. The blog carries the remarks of representatives of the agency and other interested parties VERBATIM, even when they sometimes involve harsh attacks on the conduct of the blog. Major media almost never allow such access.

I have a couple of biases that underpin what I do. One is the assumption that it is beneficial generally for the government to fund scientific research. The other and more important principle is that government agencies should operate with maximum openness and transparency and that their first obligation is to the people – not the researchers that they fund or the institutions that have something at stake.

While readers can judge for themselves the success of the blog, the scope of the readership from the NIH to California's biotech hot spots suggests it is well-received. Mainstream media reporters as well as science writers often use the California Stem Cell Report as a reference and starting point. The blog has also served as a springboard for acceptance of my own occasional freelance articles in such places as The Sacramento Bee and Wired News. And in 2012, I testified before the Institute of Medicine, at its invitation, during preparation of its $700,000 report on the stem cell agency.

As for how the work is done, the writing and reporting are performed largely from a sailboat in Mexico and Central America, on which my wife and I live full-time. Sometimes that has presented difficulties, but as cellphone and Internet service has improved over the years, the task has become easier. We make visits back to California regularly during which I meet with agency officials and others and attend CIRM's public meetings.

I have focused largely on the policy and business aspects of the agency because that is where my knowledge and background lies. During my career, I have covered and edited stories from the state Capitol for United Press International and spent 10 years as the business editor of The Sacramento Bee along with editing prize-winning investigative projects, including the 1992 Pulitzer Prize-winning series, “The Monkey Wars,” by Deborah Blum, who now teaches at the University of Wisconsin. I also served two years and one week with Jerry Brown during his 1974 campaign for governor and into his first term.

As for my financial interests, my wife and I have never had any investments in any enterprise that could benefit financially from the activities of the stem cell agency except for possibly through index-based mutual funds over which I have no control. But like most of world, my family has suffered from conditions that theoretically could benefit from development of stem cell therapies. 

I am always interested in thoughts and comments from readers, critical or otherwise. My skin is reasonably thick. I have always told reporters who have worked for me that if you perform your act in a public place you should be prepared for any sort of reaction. I welcome suggestions for stories and improvements.

Feel free to contact me at djensen@californiastemcell.com. Or if you prefer to withhold your identity, you can leave a comment anonymously via the “comment” function at the end of each item.  

Thursday, February 28, 2008

California Set for $758 Million Stem Cell Lab Construction Program

California's young stem cell agency has extracted promises of nearly $500 million in matching funds to help build what it calls one of the most ambitious medical science lab construction programs in the nation's history.

The agency announced today that the 12 competitors for $262 million in CIRM lab construction grants said they had raised the matching dollars in an effort to win the grants in May. The agency will give higher priority to institutions with larger matching funds.

The largest single "matching and leverage" amount -- $150 million -- came from Stanford, which is seeking a $50 million grant from CIRM. The San Diego Consortium for Regenerative Medicine, which consists of UC San Diego, Scripps, Salk and Burnham, offered $65 million for its $50 million grant request. UC San Francisco logged in with $54 million for a $40 million grant for its building(See photo. Larger version here).

Interestingly, UCLA came up with only $12 million matching for a $30 million request. UC Irvine offered only $23 million for a $37 million grant. (A table with the complete list of the grant requests and size of matching is available here.)

In a news release, CIRM Chairman Robert Klein said the total of about $758 million (including leverage and grants) can mean "a research infrastructure building program that historically exceeds any prior state government research facilities program for a new field of medical science anywhere in the U.S."

CIRM President Alan Trounson said,
"The research facilities established by the CIRM Major Facility Grants will provide a safe haven from federal government restrictions for stem cell scientists to conduct research that will lead to therapies and cures for millions of patients who suffer from chronic disease and injury. These grants are an important part of the CIRM’s goal of making California an ideal environment for all avenues of stem cell science to flourish."
However, none of the labs are likely to be built before a new US president changes George Bush's restrictions on stem cell funding. We understand there are other concerns about federal restrictions and have queried CIRM concerning those.

While the sums for lab construction appear vast, some of the applicants may be disappointed. The total amount of grants requested is $336 million, exceeding CIRM's budgeted $262 million by $74 million.

Earlier this year, Klein said he might ask some of the institutions to reduce the size of their requests in order to fund all of the building programs.

CIRM's Facilities Working Group is scheduled to review the applications April 4 and 5 with its decisions going to the CIRM directors for ratification May 6-7. CIRM directors have already ratified the decisions of the scientific reviewers on the grant requests.

You can find the scientific reviews here. However, that document does not list the applicants by name. You will need to pick up the number of the application from today's news release and find the same number on the scientific review document to correlate the two.

The latest applications are scheduled to be posted on the CIRM website sometime in the future. We have queried CIRM concerning that date.

(Our figures on the totals in the grant program differ slightly from those in CIRM's press release. We have based ours on the cumulative totals of the raw figures and then rounded.)

Monday, January 19, 2009

A California Stem Cell Question: Millions for Science vs. Cuts in Medical Help for the Poor

As California's public universities are turning away students and state cash is being cut for projects ranging from research labs to affordable housing, the California stem cell agency is on track to give away $66 million later this month.

The awards will come following CIRM's handout of more than $19 million last month.

No one – except for those congenitally opposed to hESC work -- is contending that all these millions are going to unworthy scientists or to dubious research. But the CIRM giveaways stand in marked contrast to what is happening to the rest of the state in the light of its $40 billion budget crisis.

If CIRM were, say, part of the state Department of Health, chances are good that it would not be able to spend taxpayer money so freely.

The disparity raises major public policy issues about the use of ballot initiatives to promote and protect various causes. Should the elderly and poor see their much-needed assistance and medical care cut while cash flows unimpeded, in this case, to researchers, some of whom are already exceedingly well funded?

A ballot initiative, Prop. 71, is just what created the $3 billion stem cell effort in 2004 – not carefully crafted legislation hammered out over months with all parties having their say in public. The measure was drafted in secret by CIRM Chairman Robert Klein (with the help of a couple of others he rarely acknowledges) and placed on the ballot with a signature-gathering effort that probably cost $1 to $2 million. (That is the most common way of placing an initiative on the ballot in California – hiring firms that specialize in such efforts and paying them on a per signature basis.)

Voters did speak, approving Prop. 71 with a 59 percent vote. However, the measure faced only the most feeble opposition. The groups concerned about ethical issues involving hESC were largely focused instead on re-electing George Bush as president.

The upshot is that the Golden State can do little now to enact even the most minor needed changes in the Prop. 71. It locked into state law and the state Constitution true minutia, such as specifying that CIRM Chairman Klein is in charge of putting out the annual report. Prop. 71 enacted super-majority quorum requirements that hamper the agency in conducting its official business and capped its staff size at a ludicrously low 50 persons to run a $3 billion program. And it created a board of directors dominated by the very enterprises that benefit the most from CIRM largess.

Klein, in order to insure that he and the agency would not have to heed the wishes of the governor or other elected officials, wrote into Prop. 71 an unprecedented, constitutional requirement for a 70 percent vote of the legislature to change the law, plus the signature of the governor. That makes it virtually politically impossible to make alterations in the measure. By contrast, even passing a budget for the state of California or raising taxes requires only a two-thirds vote. While less than that for changes in CIRM, the two-thirds requirement is now barring a solution to the state's disastrous financial problems.

All of that is a backdrop to the upcoming CIRM directors meeting Jan. 29 in Burlingame, Ca. In addition to giving away the big bucks, an overdue review of its financial condition is on the agenda. So far, however, no financial documents are posted on the CIRM web site. The subject came up last month repeatedly at the directors meeting in Irvine. Klein, however, shied away from discussing specifics.

But here are the basics: CIRM depends on state bonds for cash. The money flows directly to the agency. The governor and the legislature cannot touch it. But the state has stopped issuing bonds because of its precarious condition. CIRM says that so far it has plenty of cash. But it has awarded more than $600 million in multi-year grants, which need regular payments. One contingency Klein promises to discuss is the private placement of bonds. One would think those would have limited appeal when not even the state of California can find a market for its bonds.

Private placements, moreover, are not likely to be necessary. If California cannot get its financial act together in the next month or two, it will face problems of a magnitude that will dwarf such concerns as stem cell research. That pressure seems certain to force the state's public servants to cobble together a solution before CIRM runs aground financially. Nonetheless contingency plans are always good.

The grants scheduled to be awarded include $18 million to support up to 10 awards for three years "to augment the ranks of laboratory personnel trained in the state-of-the-art techniques required by stem cell research labs." Certainly a worthy endeavor while the state's educational institutions are being whipsawed financially.

The second round involves $48 million in training grants for young scientists, including stipends of up to $77,000 for three years, including research and travel, tuition and health insurance in some cases. Another worthy endeavor, an investment in the future. It is a remake of the first-ever grants awarded by CIRM in September 2005. The agency didn't have the money then to fund the grants immediately, but the cash ultimately came through and helped make the state attractive to new, young talent.

If you have thoughts on any of these issues, you can comment below by clicking on the word "comment" or you can write CIRM directly via its web site and ask to have your comments made part of the public comment allowed at each CIRM board meeting.

Wednesday, April 11, 2007

Stem Cell Snippets: Labs, Cha and Pomeroy

Wasteful Lab Duplication – Reporter Nicole Gaouette of the Los Angeles Times wrote about how George Bush's stem cell funding edict has resulted in wasteful efforts in stem cell research. The article indirectly raises a question about how much money NIH spends chasing down possible violations of the ambiguous and dubious directive. Gaouette uses examples from UC San Francisco and Advanced Cell Technology in Alameda, Ca.

Cash for Large Stem Cell Facilities – Reporter Terri Somers of the San Diego Union-Tribune reported that CIRM hopes to have $225 million available for large stem cell research labs. Applications could be ready this summer. Recipients would have match at least 20 percent of the grant, according to the initial proposal.

CHAThe Scientist magazine has the latest on the Cha affair with a statement from Alan DeCherney that the publications committee of the American Society for Reproductive Medicine will meet Friday to discuss the matter. Also now available onine is the full text of the British Medical Journal article concerning the case.

PomeroyClaire Pomeroy, a member of the CIRM Oversight Committee and dean of the UC Davis School of Medicine, discusses stem cell issues in the Sacramento News and Review. Among other things, she worries about stem cell tourism – the practice of folks seeking stem cell therapies abroad. In many cases, inadequate oversight exists. She also reviews the status of stem cell research at the UC Davis campus. The Cal Aggie campus newspaper also carried a piece on a presentation to the Oversight Committee Tuesday on vascular disease research.

CIRM Litigation – The folks seeking to put CIRM out of business have filed with the State Supreme Court their request to overturn two earlier decisions against them. The court has until June 5 to make its decision.

State of Affairs – Reporter David Louie broadcast a piece on San Francisco TV station KGO on April 10 that reviewed the stem state of affairs in California. He said that thanks to CIRM, the state is
"is already well on the way to making its own breakthroughs in stem cell research."

Tuesday, February 11, 2014

California Stem Cell Agency Shies Away from a $200 Million Possibility

The California stem cell agency has backed far, far away from a tobacco tax initiative that would provide it with more than $200 million a year – funds that could save it from an untimely demise in a few short years.

The leadership of the $3 billion enterprise fears that the tobacco industry would tar the entire stem cell research field in a no-holds-barred ballot campaign financed with $50 million or more.

CIRM Chairman Jonathan Thomas said that the tobacco industry would paint “a very negative, and unnecessarily so, picture of stem cell research and would very likely result in a measure that would go down and create a chilling effect on the view of all the good we've done.”

In a reference to the tobacco industry, he said,
“These guys, they play for keeps, and they say things in their ads...that are misleading or inaccurate, but there's nothing you can do about it.”
Thomas said that initially the ballot proposal sounded “great” but after agency officials talked to political consultants and pollsters, their perspective changed.

He said that he understood that the agency is being written out of the proposed initiative which is aimed at funding a wide range of brain research.

Thomas made his comments at a meeting of the only state body charged with overseeing the finances of the stem cell agency – the Citizens Financial Accountability and Oversight Committee, which is chaired by State Controller John Chiang. Thomas was commenting in connection with the fact that the agency will run out of funds for new grants in the latter part of 2017.

Our take: Thomas is correct that it would be a bloody campaign. Stem cell research is a big target. However, the tobacco industry is even bigger. It needed to spend $50 million to very narrowly defeat a similar tax measure in 2012 by only 30,000 votes out of 5 million cast.

A successful campaign for the stem cell agency would be about life (stem cells) versus death (tobacco). Indeed, a truly vicious campaign by the tobacco industry could well backfire on the industry, creating even more antipathy and animosity than now exists. A winning ballot measure also needs a good villain to help rally support. In 2004, when the stem cell agency was created, the campaign had that villain -- former President George Bush and his restrictions on human embryonic stem cell research. 

A ballot proposal could win but it would take a united front, an early start and a willingness to take some fire.

Important policy issues, however, would arise involving dedication of tax revenues for a specific purpose, one of the reasons the state of California has had financial difficulties.

All of which is moot since the agency has made it clear that it is not game for the battle.

Tuesday, January 17, 2017

The $22,000-an-Hour California Stem Cell Story: Rosy Expectations, Fuzzy Future

Evangelina Padilla Vaccaro
CIRM photo
Highlights
Trump and state bond issue?
More than 60 clinical trials projected
No therapies yet for general public
Siren appeal for reseachers
$2.2 billion out the door


Evangelina Padilla Vaccaro – a pink bow in her hair – was likely the first four-year-old ever to address the leaders of California’s $3 billion stem cell research program.

“Thank you,” she whispered. Her mother said more: 
"Thank you for keeping my family complete." 

Alysia PadillaVaccaro’s voice cracked, and tears flowed on that cool December morning at the meeting at an Oakland hotel.

Evangelina had much to be thankful for. She was born with “bubble baby” syndrome, which meant that she had no functioning immune system. Scientist Donald Kohn of UCLA cured her of the rare affliction by using her own blood stem cells to alter a troublesome gene. It was an experimental treatment not readily available to the public at large. Kohn’s research has been heavily supported with nearly $52 million by the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM) .

Evangelina’s story is just what Californians hoped for when they created the Oakland-based agency in 2004 via Proposition 71. Voters were told that stem cell therapies would ease afflictions found in nearly 50 percent of California families. The agency would create the “cures for tomorrow,” said then Gov. Arnold Schwarzenegger.

Since its first awards in 2005, the agency has given away money at a rate of $22,000 an hour, seven days a week, 24 hours a day. But it has yet to come up with a therapy that reaches the general public despite rosy expectations raised by the ballot campaign.

Today, the future of the program is unclear. The agency calculates that it will run out of cash in just three years. Whether it lives on could depend on the likelihood of another multibillion-dollar bond issue, not to mention the success – or the lack of success – of as many as 60 or more clinical trials and even the policies of the newly elected president of the United States, Donald Trump.

Stem cell therapies, it turns out, are expensive and difficult to bring to market, and their use may be
Shinya Yamanaka, UCSF photo
limited to a handful of diseases. On Monday, Nobel Prize winning stem cell scientist Shinya

Yamanaka said as much in an interview with Wallace Ravven of The New York Times. Because of a wide variety of constraints, he said, 
“We can help just a small portion of patients with stem cell therapy.”
In this context, heartwarming stories of patients such as Evangelina could be some of the strongest selling points for CIRM’s continued existence. They could fire the enthusiasm of voters and embolden businesses to partner with CIRM to bring therapies into the marketplace. The number of these emotional stories is increasing.

Evangelina was not alone at the CIRM meeting last month. Three more patients stepped up during a look at the agency’s performance. They included a 22-year-old man, also with a rare, immune-deficiency disease, a paralyzed 19-year-old man and a 70-year-old cancer patient -- all of whom had experienced major improvements during clinical trials. All told, the agency has pumped $113 million into the research that has benefited the four patients.

Evangelina’s story had special significance for Jan Nolta, head of the UC Davis stem cell program.
Jan Nolta, UCD photo
Nolta began her career working with Donald Kohn at Childrens Hospital in Los Angeles in early research involving the “bubble baby” affliction.

“CIRM has funded Don’s continued work in this area, and he has now functionally cured over 20 children with this disease,” she said in an email. “These kids now need no expensive medicine and treatments to keep them alive. They are functionally cured.” 
In Evangelina’s case, she was able to join her fraternal twin sister, Annabella, in living a normal childhood.

CIRM funding has also fueled the growth of the UC Davis stem cell program, which barely existed prior to creation of the stem cell agency. Today Davis has chalked up $129 million from the agency. “We have 16 stem cell or regenerative medicine clinical trials ongoing or recently completed, with more than 20 in the pipeline,” Nolta said.

Davis ranks as the No. 5 recipient of funds from the agency, trailing only such institutions as Stanford, $314 million; UCLA, $269 million; UC San Diego, $170 million, and UC San Francisco, $139 million.

Nolta is one of a number of researchers attracted by CIRM, lured by the cash and research environment created by the stem cell agency. program. She returned to California from Washington University in St. Louis. 
(See the full text of Nolta's remarks here.)

The appeal of the California largess was highlighted last week by George Daley, dean of the Harvard Medical School.  He was quoted in a lengthy piece about San Francisco Bay Area biotech written by STAT news service editor Charles Piller.
"'I’ve been looking at this from the outside, and franly have been very envious as a scientist based in Massachusetts,' Daley said. CIRM funds have turned many research centers in California, including UCSF, into world leaders in stem cell science, he said, adding: 'I heard the siren song of CIRM early. I considered making a move,' as did more than two dozen of his Harvard stem cell colleagues."
Since CIRM’s inception, it has awarded $2.2 billion to 853 California researchers and institutions. It estimates that it will award another $692 million before money runs out. This year it plans to give away $328 million.  (The awards are separate from the agency’s operational budget, which is capped by the ballot initiative and is about $19 million for the current fiscal year.)

Like most other recipient institutions, UC Davis has representation on the CIRM governing board. The California Stem Cell Report, which has monitored the agency since 2005, has calculated that about 90 percent of the agency’s cash has gone to institutions with links to past or present board members. Those members are barred from voting on awards to their institutions, but they do vote on the nature of the award rounds and approve the rules.

Concerns about conflicts of interest have long been a bugaboo for the agency. Last September,The Sacramento Bee reported that its former president, Alan Trounson, received $443,500 in total compensation after being named in 2014 to the board of directors of StemCells, Inc., of Newark, Ca. Trounson’s appointment to the company’s board came only seven days after he left the agency at the end of June 2014.

Randy Mills, FDA photo
Trounson was replaced by C. Randal Mills, who had been president of Osiris Therapeutics, Inc., of Maryland. Under Mills’ leadership, Osiris was the first company in the world to commercialize a stem cell drug, qualifying it for use in Canada.

Mills and the CIRM team – currently comprised of 48 people – re-crafted the agency’s objectives and established measurable benchmarks for success, winning board approval for what Mills called radical change. The results were summarized at last month’s board meeting and in the 2016 annual report. They included:


  • Over the last two years, the agency has helped to finance 27 clinical trials and is looking for another 40 by 2020. (Clinical trials are the last stage before a therapy is approved by the Food and Drug Administration (FDA) for widespread use. Only one out of 10 conventional drug products emerge successfully from the trials.)

  • More than 250 projects are currently being managed by the CIRM team.

  • Twelve "world-class" research facilities have been created over the last 12 years.

  • Three Alpha Clinics, intended to be one-stop stem cell centers, are in operation. A fourth is scheduled for this year.

  • A $30 million stem cell "pitching machine" to speed clinical trials and help guide development through federal regulations began operations in 2016.

Nonetheless, development of stem cell therapies -- much less cures -- is a risky business and could be stymied by a number of issues. The agency itself acknowledges risk factors that include reluctance by businesses to invest in stem cell therapies and safety concerns, including the possible death of a patient in a clinical trial.

Mills makes a practice of presenting risk, an innovation at the agency, as he offers up new programs to its governing board. In the annual report, he quoted the poet T.S. Eliot as saying,

“Only those who will risk going too far can possibly find out how far one can go.”


The agency has experienced a few hiccups since Mills arrived. He acknowledges he is still working hard on attracting businesses to partner with scientists to turn their research into cures. 

An ambitious effort to create a unique, public-private, $150 million enterprise to develop stem cell therapies and cures stumbled late last year when no qualified applicants surfaced from the private sector. The agency hopes to recast the proposal in such a manner that it will find a partner.

One of those watching the agency since its beginning is Hank Greely, director of the Center for Law
Hank Greely, Stanford Law photo
and the Biosciences at Stanford.


He said in an email,

“CIRM has been spending money from Proposition. 71 for about 10 years. Once initial hopes of finding low-hanging fruit disappeared, this kind of slog toward treatments became inevitable.  (Although, in biomedicine, 10 years is not (Greely's boldface) a long time - see the 35 plus years it has taken gene therapy to get to the edge of an FDA-approved product.)


“The next few years should determine just how good California's investment has been. It is encouraging to see CIRM supporting so many clinical trials; it will be much more exciting when – and I do expect ‘when’ and not ‘if’ – one of those trials leads to an approved treatment.”
 

John M. Simpson of Consumer Watchdog of Santa Monica, Ca., has also observed the agency for years. He said in an email,

“CIRM’s fundamental problem is that supporters of Proposition 71 wildly oversold what passage of the measure would deliver. Voters were led to believe that miraculous cures were just around the corner if only the proposition passed.

“CIRM-funded research has made important contributions to science, but has yet to deliver what voters were promised,” Simpson said. He added that agency management has improved under the regime of CIRM Chairman Jonathan Thomas and Mills “and the most blatant conflicts of interest were mitigated after the scathing Institute of Medicine report.”

In 2012, the highly respected Institute of Medicine, in a $700,000 report commissioned by the agency, recommended sweeping changes at CIRM to deal with conflicts of interest, its dual executive arrangement and the composition of its governing board. The CIRM board initially greeted the report coldly but made some changes to deal with the critical findings.



California patient advocate Don C. Reed, who campaigned for stem cell research long before CIRM surfaced, however, hailed the agency's work as already saving lives and creating hope for millions. He said in an email it was a "quiet triumph" that can be built on. (See here for full text.)

Simpson, who was heavily involved in development of the agency’s intellectual property policy,
John M. Simpson
 Consumer Watchdog photo
raised questions about the failure of the agency to generate the $1.1 billion in royalties for the state promised by its backers. Simpson said,


“The CIRM annual report cites the number of ‘inventions’ CIRM has funded — more than 180.  What share of royalties have taxpayers received as a result? Anticipated revenue from CIRM-funded inventions was a big selling point for Proposition 71.”

(See here for the full text of Simpson's comments.)

 Ironically, another selling point for the ballot measure came inadvertently from former President George Bush, who had restricted federal funding for human embryonic stem cell research. Backers of the ballot measure said it was needed to compensate for Bush’s action. His restrictions were lifted by President Obama. But many researchers are worried that the Trump administration will once again limit federal support for stem cell research.

Stanford’s Greely said,

“The election of Donald Trump and the continuation of a Republican-controlled Congress could create an increased need for extending CIRM.  If the federal government pulls out of some research on basically religious grounds, California may want to step in again.  It depends both on exactly how restrictive the federal government becomes and, more subtly, on how promising the stem cell trials appear.

“I suspect some federal funding restrictions are inevitable but their scope is unpredictable. As to the trials, if they are tremendously exciting, private funds might take over; if they flop, state funds may not be appropriate.  But if the results are very promising but not spectacular, more state funding might be invaluable.” 

(For more on a possible bond election and Trump's position, see here, here, here and here.)

Simpson has another view. He said,

“No doubt CIRM-funded research has made some important contributions to scientific knowledge. The results, however, in no way justify another bond issue to fund the agency.  If CIRM continues after the current funds run out, it should be financed like any other state agency— out of the state’s operating budget approved by the Legislature on annual basis. CIRM’s operating budget could also be augmented by private contributions.”

Mills avoids public discussion of such things as bond measures. But at a meeting last fall, he likened the research program to a “giant flywheel.”
“It takes a long time to get started, and you move it imperceptibly. Once that thing gets turning, it's almost impossible to stop.”

(Editor's note: A shorter version of this story can be found in the print edition of The Sacramento Bee for Jan. 17, 2017, and also on The Bee's website. The full text of various comments follows this story, which also has links to them. Greely's complete comments were included in the article above.)

(On Jan. 19, STAT news carried a lengthy piece on the agency that said it was slow in financing clinical trials, a major factor that has hampered development of a therapy.)

(An earlier version of this item also incorrectly stated Evangelina's age.)

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