Showing posts with label sustainability. Show all posts
Showing posts with label sustainability. Show all posts

Tuesday, December 08, 2020

Vote Count on $5.5 Billion Stem Cell Measure Nearing its Official End

With no votes left uncounted, the ballot initiative that saved the financial life of California's now $12 billion stem cell program has topped out at 51.1 percent approval compared to 48.9 against. 

The count reflects the most recent state election figures from late Friday. None of California's 58 counties is reporting that it has ballots yet to count. 

The raw numbers are 8,588,156 for Proposition 14 and 8,221,692 against. The measure provides $5.5 billion that the state will borrow over the next decade to fund the operations of the California Institute for Regenerative Medicine (CIRM). 

Official certification of the election results is required by Friday.

CIRM was created by another ballot initiative in 2004 with $3 billion in state bonds. That money has nearly run out, and the agency was set to close its doors beginning this month. However, the passage of Proposition 14 saved CIRM. 

The measure provides no additional funding beyond the $5.5 billion. It will run out in 11 or so years, unless the agency slows its expected rate of spending. Because the money is borrowed, interest adds to the cost of the research and to the cost to taxpayers, bringing the estimated total expense to $12 billion. 

8,588,15651.1%8,221,69248.9%


Thursday, December 03, 2020

Save the Goose: California's Stem Cell Story and the 'Army of 900'

Is the stork bringing stem cell billions?



More post-election coverage is trickling out regarding the activities of the $12 billion California stem cell agency, including a lengthy and compelling piece in the Los Angeles Times, the state's largest circulation newspaper. 

The hitch is that the Times piece does not mention the stem cell agency until the 21st paragraph, a fact that carries more weight than the 40 words in the paragraph itself. 

The article in the Times, written by columnist Sandy Banks, was not really about CIRM per se. But it was a story that might not have been told without a $13 million check from CIRM. 

The piece dealt with sickle cell disease. Banks' entry point was a patient named Evie Junior, whose harrowing experiences are certain to resonate with nearly all the paper's readers. 

Banks wrote,
"As a child, (Junior) grew accustomed to frequent hospital stays. But the disease got progressively worse as he moved through his teens; the bone pain was so disabling, he often had to be sedated with heavy-duty opioids."
Banks continued,
"At one point, the bones in both his legs were so damaged by the disease, doctors thought he might not ever walk normally again. Junior battled back."
Banks wrote,
“'I want to be cured of this disease,' he said. 'And I wish the world was more understanding about the people who are struggling with it.'”
Junior is a patient in a UCLA clinical trial led by Donald Kohn, whose research has been supported by a total of $52 million from the stem cell agency -- a figure not noted in the story. 

The stem cell agency comes into the story ever so briefly at paragraph 21. "The trial is funded by the California Institute for Regenerative Medicine (CIRM), the stem cell agency created by voters in 2004 and infused with $5.5 billion in new research money by voters who narrowly approved Proposition 14 this fall," the Times reported.

That is the first and last mention of California's stem cell program in the Times' story. However, that is better treatment of CIRM than is found in most stories in the media over the last few years -- the ones that deal with accomplishments tied to the agency's cash. (See here and also here.) The articles rarely mention where the money comes from. It could be flown in by stork, for all the readers know. 

Why is this important? The answer has to do with CIRM's reliance on tenuous, ballot-box financing and the sustainability of the California stem cell program.  The situation should be of interest to a little known state entity, which is the only state panel that has a legal charge to review the stem cell program.  

The panel is the Citizens Financial Accountability and Oversight Committee (CFAOC). It was created by the same ballot initiative that established the stem cell agency 16 years ago. Last month, at the CFAOC's once-a-year meeting, its members urged the agency to make itself better known. 

Proposition 14 saved the agency from financial extinction. But the measure was a squeaker, and it set the stage for another life-or-death ballot initiative. The money from Proposition 14 runs out in about 11 years. No other source of funding is provided. If CIRM goes to the ballot again in less than a decade or so, it will need a strong base of support from California voters, 8.2 million of whom voted last month to cut off funding for CIRM.

Building a solid base takes years. It also requires something of a change involving the scientific community and science journalism, which is a big ask. The tradition in scientific journals regarding funding is to relegate mention of the sources of money to a tiny footnote as if it were not the lifeblood of research.

Science writers -- the few that now exist in the mainstream media -- follow that ancient and tired public tradition of ignoring what makes research happen. They focus on "exciting" results from the bench and clinic -- not the "filthy lucre" that pays scientists, their institutions, the post-docs who labor behind the microscopes, the equipment suppliers and keeps the lights on.

Recipient institutions write the news releases -- the starting point for most journalists -- without mentioning the many, many billions that taxpayers (state and federal) have provided. Even the stem cell agency itself does not mention dollar amounts in its blog items dealing with significant results from CIRM research. (For an example, see this item from the agency's blog on the UCLA/Kohn sickle cell trial, which CIRM is funding with $13.1 million. That figure is not directly revealed in the blog item.)

Like most state agencies, CIRM is ignored by the media with only occasional exceptions. Its activities are not well known. That is not likely to change over the next decade despite the best efforts of CIRM's tiny staff. The exception would be a major or even minor scandal or development of a major breakthrough that would resonate with the people of California.

The folks in the media have a vast array of topics to cover, all of which CIRM competes with for attention. The news industry is, in fact, overwhelmed by matters that need public scrutiny: schooling for children, jobs for parents, affordability for housing, vaccines for Covid-19, homelessness, climate change, wildfires and much, much more. Meanwhile, the industry is
 struggling with its own sustainability issues, laying off thousands of reporters, closing outlets and desperately searching for new business models.

Breaking through this wall of issues to generate favorable, regular coverage of the stem cell agency's good works is a herculean task. And so far, the reality is that CIRM's good works are quite minor in terms of how they affect the lives of the vast majority of the people in California. 

The CIRM team, from top to bottom, has provided 
a prodigious amount of positive information that can resonate with the public. Building positive relationships with voters, however, is a long-term task that requires commitments that go well beyond CIRM's stalwart staffers, who currently weigh in at only 33 for a multibillion dollar program. 

CIRM has major budget and legal limitations, courtesy of Proposition 14. Its outreach team is small, again an outgrowth of ballot initiatives. Nonetheless, CIRM has a potential army of more than 900 available plus more in the future, given the agency's expansive, new responsibilities authorized by Proposition 14. And that doesn't count the patient advocates or their allied organizations.

The army of 900 consists of the researchers and institutions that have received cash from CIRM -- all potential missionaries who can carry the CIRM message from Yreka in the north to Calexico in the south. 

The institutions could highlight CIRM funding in their news releases, instead of burying or omitting it. Researchers could reach out regularly to the various affected communities to help keep the cash flowing. Grantees could pony up $2,000 each and send it off to a new, broad-based nonprofit that might be called something like "Friends of CIRM."

But more immediately, the army of 900 could -- one by one -- resolve to make six new contacts in 2021 with the public or media to tell the CIRM story. Doing so would serve science and CIRM not to mention themselves.

The next statewide election best suited for approval of another bond measure is fast approaching. It is only eight years away. That is much less time than it takes to complete the preclinical work and clinical trials needed for a federally approved stem cell treatment, which is, ultimately, the only thing that voters really want. 

If the army of 900 needs an inspirational motto, it could be something like "Save The Goose."  You know, the one that lays the Golden Eggs. It is better than relying on the stork. 

Monday, November 23, 2020

California's Stem Cell Research Program: How $3 Billion is Growing to $12 Billion

California's 16-year-old stem cell research program is a prodigious enterprise that is helping to finance 68 clinical trials and that has funded hundreds of California scientists for their work in an embryonic field, so to speak. 

The scope and importance of the program and its cost, however, are not necessarily apparent to most Californians. The program is not high on the radar of most people and certainly not the subject of breakfast table conversations in the overwhelming majority of the state's households. 

Over the past 16 years, the California Stem Cell Report has regularly described the stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM), as a $3 billion effort. But the use of that number did not make it clear that the cost ran significantly higher. 

When CIRM was created through a ballot initiative in 2004, the state Legislative Analyst estimated it could cost taxpayers $6 billion because of the interest on the money that the state borrowed to finance it. The figure has turned out to be closer to $4 billion because of unusually low-interest rates over the last decade or so. 

Under Proposition 14, the agency will receive an additional $5.5 billion from state bonds to spend on research and other new programs. The state legislative analyst has estimated the total cost will run about $7.8 billion because of -- once again -- interest costs. 

The Proposition 14 funding brings the total estimated cost of CIRM to nearly $12 billion.  And that is the figure that the California Stem Cell Report will use going forward to describe the program, unless someone can convince this writer otherwise. 

Referring to CIRM as a $12 billion enterprise immediately tells the reader that it is a significant effort. The number helps to draw readers into stories about CIRM. It is also more accurate than using a smaller figure, which would tend to minimize the cost and mislead taxpayers. Describing CIRM only as a $8.5 billion ($3 billion plus $5.5 billion) agency tends to conceal its true cost to the people of California. (In retrospect, this website should have used the 2004, $6 billion figure to describe CIRM over the last 16 years.)

CIRM is a rare bird among state agencies for a number of reasons. In this case, we know that its funding will cease at some point. Nearly all state departments do not live with that sort of financial guillotine.  

The 17,000-word ballot initiative, crafted by Robert Klein, a Palo Alto real estate developer, limits CIRM's annual CIRM bond sales to $540 million. Based on the experience under the previous initiative -- Proposition 71 of 2004, which created CIRM -- the agency is not likely to hit the $540 million cap each year. That could extend CIRM's possible life for another 15 years or so unless it becomes unusually tight-fisted.

As for the $12 billion figure, this writer is open to arguments for using another number, but I will have to be convinced. I am prepared to air those arguments (their full text) on this website. So if a reader thinks another figure is more appropriate, please let me know the reasons why either by filing a comment using the comment function at the end of this item or by sending me an email at djensen@californiastemcellreport.com.

Thursday, April 17, 2014

NIH Action on Stem Cells: More Than 'Bureaucratic Bungling'

A national stem cell advocacy group this week ripped the National Institutes of Health (NIH) for “dismantling” its Center for Regenerative Medicine, describing the move as a "setback" for the entire field.

Bernard Siegel
GPI photo
The Genetics Policy Institute (GPI) said the action was a “huge disappointment” in an email sent out internationally by Bernard Siegel, executive director of the group, which stages the heavily attended World Stem Cell Summit.

The NIH move also has implications for the California Institute for Regenerative Medicine(CIRM), whose $3 billion program is down to its last $600 million.

The GPI was reacting to news in the journal Nature that the NIH said its center “will not continue in its present form.” The head of the NIH program, Mahendra Rao, took a job this month with the New York Stem Cell Foundation. James Anderson, director of the NIH’s Division of Program Coordination, Planning, and Strategic Initiatives, told Nature that the $52 million NIH effort was going to be rethought following a workshop in May.

Siegel said,
“The dismantling of the program appears to be a retreat by the United States from the translational imperative and a setback for the field at large. The patient community will be looking to Dr. Collins(head of the NIH) and others in NIH leadership to fulfill their commitment to stem cell development as a singular priority. Other countries are pouring in resources and moving full steam ahead. The NIH’s failure to continue the program represents more than just a case bureaucratic bungling. What we see here is a lack of vision and a public relations blunder. Years of valuable work and planning just tossed away. The scientific community and the public rightfully believes regenerative medicine will one day provide innovative treatments and cures to chronic diseases. The decision to tear down the Center for Regenerative Medicine, without first providing an alternative plan, undermines the credibility of NIH. A huge disappointment."

Asked for a response this week by the California Stem Cell Report, Amanda Fine, a public affairs specialist at the NIH, said in an email,
“The NIH Intramural Center for Regenerative Medicine has not closed.  This is a fast evolving area of science and NIH decided to step back and reassess what the field needs in 2014 and beyond and where NIH can have the greatest impact. NIH is holding a workshop tentatively scheduled for May 5 that will convene a group of experts in the field to address current obstacles to translation of cell therapies and will help prioritize a number of requirements that the larger community has articulated through white papers over the past two years.  NIH will consider the feedback from the workshop and establish a set of goals for the CRM.

Initially, Fine asked that the NIH statement not be attributed to a specific individual but later
said it could be attributed to James Anderson, who also made the statements to Nature.

Public details of the NIH program and its problems are murky. But the NIH action has implications for the California stem cell agency, which is scheduled to run out of cash for new awards in 2017. The agency is attempting to raise funds to continue beyond that point.

The agency could use the news to argue that now, more than ever, it is necessary to support stem cell research efforts in California because of weak federal support, which ebbs and flows depending on political vagaries. On the other hand, some might interpret the NIH rollback as a sign that those well-informed in the field have judged it to be less-than-ready for prime time, an argument that could be extended to California's efforts.

What the NIH action clearly does is create more uncertainty concerning progress in stem cell research. Uncertainty is an anathema to businesses that may be considering where to invest hundreds of millions of dollars.

Sunday, March 16, 2014

The Boom in Privatized Science and the California Stem Cell Agency

Billionaire science is booming, the New York Times said today, and it is raising serious concerns along with a hearty huzzah for the infusion of increasingly scarce cash for research.

The lengthy piece by William Broad was headlined, 
“Billionaires with big ideas are privatizing American science."

 Broad wrote,
“American science, long a source of national power and pride, is increasingly becoming a private enterprise. 
“In Washington, budget cuts have left the nation’s research complex reeling. Labs are closing. Scientists are being laid off. Projects are being put on the shelf, especially in the risky, freewheeling realm of basic research. Yet from Silicon Valley to Wall Street, science philanthropy is hot, as many of the richest Americans seek to reinvent themselves as patrons of social progress through science research. 
“The result is a new calculus of influence and priorities that the scientific community views with a mix of gratitude and trepidation.”

The trend has implications for California's $3 billion stem cell agency, which will run out of cash for new awards in 2017. It is currently engaged in what it calls a “sustainability” effort, which simply means it is searching for ways to raise more money. One possibility is another state bond measure, which would require voter approval and an expensive ballot campaign. Another more likely prospect is some sort of private funding arrangement, including creation of a nonprofit organization to accept donations from the very sort of billionaires, plus businesses, that the Times discussed.

In 2008, Eli and Edythe Broad gave $25 million
to UC San Francisco to help build a stem cell
research center funded by the California stem
cell agency. Then Gov. Schwarzenegger (at left)
attended the groundbreaking. Broad stands with
 his wife. Former CIRM Chairman Robert Klein
is in the background with a gray tie.
UCSF photo
The list in the Times is relatively long and includes Bill Gates of Microsoft, Eric Schmidt of Google and Larry Ellison of Oracle. Also mentioned was Eli Broad, who has made large contributions to stem cell efforts in California. Not mentioned, oddly enough, was Denny Sanford, who last fall donated $100 million for stem cell research at UC San Diego.

The Times article said the “personal setting of priorities is precisely what troubles some in the science establishment.” Also raising concerns is the enrichment of elite universities at the expense of poorer ones.

Nonetheless, reporter Broad wrote that the influence of billionaire donors is likely to grow given their wealth and the national budget wars. One study cited in his piece shows that at the 50 leading science research universities, private donors already account for roughly 30 percent of the schools' research money.

One of the priorities of the private donors is translational research, the type currently being emphasized by California's stem cell agency, which some fear could lead to the neglect of basic research. The Times cited an effort begun in 2000 by the Cystic Fibrosis Foundation. The Broad story said,
“With great skill, it used the money to establish partnerships across industry and academia, smashing through the walls that typically form around research teams. By early 2012, the financial surge produced the first treatment for an underlying cause of cystic fibrosis.”

The timeline on that treatment is not too different than what might be considered the timeline set in Prop. 71, which created the California stem cell agency. The ballot measure provided for 10 years of funding via money borrowed by the state. Although the measure was passed in 2004, legal battles delayed issuance of the bonds, meaning that the agency's financial clock has not yet completely run out. As for commercial cures built on agency research, no one at the agency is publicly predicting their entry into the market place within the next three years.

Monday, February 11, 2013

No Improper Influence: CIRM Defends 'No Actual Conflicts' Claim

Earlier this month the California Stem Cell Report  published an item that said:
“In the wake of recent considerable criticism concerning conflicts of interest at the $3 billion California stem cell agency, its leaders have taken to saying 'no actual conflicts' have been found at the agency.
“That assertion is simply not true.”
We asked the stem cell agency if it would like to respond and said that its response would be carried verbatim. The agency's comments are below. Our take on the response follows the CIRM comments, which were authored by Kevin McCormack, the agency's senior director for public communications and patient advocate outreach.

In David Jensen’s recent blog about the stem cell agency he claims to “debunk” claims that there have been no actual conflicts in CIRM’s funding decisions saying “the agency has a long history of problems involving conflicts of interest, 'actual' and otherwise.” In fact, in the cases cited by Mr. Jensen, show 'otherwise' is the appropriate word here because as we’ll show CIRM’s conflict procedures worked and the funding decisions were not affected by any improper influence.
Let’s take it case by case, looking at each instance of a “conflict” cited by Mr. Jensen.
John Reed
In 2007, John Reed, a member of the stem cell agency’s Governing Board, contacted staff in his capacity as the president of the Burnham Institute after the Board approved a SEED grant award to a Burnham investigator. Dr. Reed did not participate in the Board’s decision to approve the award and played no role in that decision. All he did was send a letter to CIRM staff after the Board meeting to provide factual information in response to technical questions raised by CIRM staff concerning the investigator’s eligibility for an award. Those questions ultimately led staff to reject the grant. Because the Board had already made the decision to award the grant, it did not occur to Dr. Reed that the conflict rules would prevent him from contacting staff to provide relevant information. And why would it? The decision was made so there was nothing to influence. After CIRM staff received Dr. Reed’s letter, they informed Dr. Reed that he must refrain from participating in any way in CIRM's consideration of the Burnham grant. In addition, CIRM staff did not consider the letter in conducting their administrative review of the Burnham grant and their determination that the investigator was not eligible did not change. The FPPC determined that, although Dr. Reed’s conduct raised ethical concerns, he had not violated conflict of interest laws because he attempted to influence a decision that had already been made. Furthermore, Dr. Reed’s conduct did not affect a CIRM funding decision because the grant was rejected by CIRM staff.
New Faculty Awards
When a candidate applies for a CIRM New Faculty Award it is standard practice for them to include a letter of support from the institution where they hope to be working. In December 2007, during a review of applications for New Faculty Awards, CIRM staff discovered that ten applications were accompanied by letters of institutional support signed by members of the Board. This was due to a miscommunication by staff, a poorly drafted memo to Board members leading them to think it was OK to sign the letters of institutional support. The error was discovered before the Board considered any of the applications. CIRM staff determined that the letters could be perceived to create a conflict of interest and so, to avoid even the appearance of a conflict, CIRM staff disqualified the ten applications. As a result, the applications were not presented to the Board for its consideration, thereby avoiding any potential for a conflict of interest in a funding decision.
John Sladek
In 2011, while preparing the public summary for Basic Biology III applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application. This is a technical violation of the Grants Working Group (“GWG”) conflict policy, which prohibits a member of the GWG from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window. It should be noted, however, that Dr. Sladek’s participation in the review of the application would not have constituted a conflict of interest under state conflict of interest laws because Dr. Sladek did not have a financial interest in the application. In addition, the amount of funding involved – approximately $3,000 of salary per year for three years, less than one percent of the total award – was not material, and Dr. Sladek did not stand to receive any financial benefit from the application. Finally, Dr. Sladek’s participation in the review did not affect the outcome because the application was not recommended, or approved, for funding.
The three instances cited by Mr. Jensen share two common features. First, CIRM staff identified the potential for a conflict before any funding decision was made. Second, CIRM’s funding decisions were not affected by any improper influence.
Ted Love
Mr. Jensen also cites the service of Dr. Ted Love, a member of the Board who volunteered his time to assist CIRM in offering his scientific and medical expertise, as evidence of a conflict of interest. Although Mr. Jensen insinuates that Dr. Love’s service constituted a conflict of interest, he does not cite any facts, except Dr. Love’s “deep connections to the biomedical industry.” But the fact that Dr. Love has experience in the biotech industry does not constitute a conflict of interest, and as a member of the Board and as a volunteer to CIRM, Dr. Love abided by CIRM’s conflict of interest policies.
In the past Mr. Jensen has criticized the stem cell agency for its lack of connections and engagement with industry. In this case he criticizes us precisely because of our connection and engagement with someone who has industry experience.
Venture Capital Firm
Mr. Jensen also suggests that a conflict of interest arose from the fact that “iPierian,Inc., whose major investors [a venture capital firm] contributed nearly $6 million to the ballot measure that created the stem cell agency, has received $7.1 million in awards from the agency.” While it is true that Proposition 71 involved a multi-million dollar campaign, the funding for the campaign came primarily from individuals who had a family member who suffered from a chronic disease or injury, including individuals associated with a venture capital firm. The firm itself did not contribute to the campaign, nor did the campaign accept contributions from biotechnology or pharmaceutical companies. Furthermore, the venture capital firm did not invest in a CIRM grantee; rather, it invested in a different company which subsequently merged with yet another company to form an entity that later applied for, and was awarded a CIRM grant.
Stem Cells, Inc.
Mr. Jensen cites CIRM’s award to Stem Cells, Inc. as another source of a conflict. In support of this claim, Mr. Jensen’s references Bob Klein’s support of the award, as well as the fact that Irv Weissman, PhD, appeared in an ad for Proposition 71 in 2004. However, neither Mr. Klein’s support for the award nor Dr. Weissman’s support for Proposition 71 constitutes a conflict of interest. First, Mr. Klein, like any member of the public, has the right to express his views to the Board. The state’s revolving door laws do not apply to a former member of the Board who, like Mr. Klein, is not compensated for making an appearance. As for Dr. Weissman’s support for Proposition 71, nothing in state law prohibits a member of the public from seeking CIRM funding even though he supported the measure during the campaign. In fact, it would be reasonable to expect that most stem cell scientists in California (and elsewhere) supported Proposition 71. Disqualifying individuals from receiving funding because they supported the law would leave few, if any, eligible applicants.
Allegation of Conflict at Board Meeting
As further evidence of an “actual conflict”, Mr. Jensen cites another instance in 2008 in which a representative of a for-profit applicant publicly complained at a Board meeting that a member of the GWG had a conflict of interest “from a business perspective.” As provided for by CIRM’s regulations, the applicant had filed an appeal, claiming that the reviewer had a conflict of interest because he had a financial relationship with another company that was not an applicant for CIRM funding. CIRM’s legal counsel reviewed the appeal and determined that there was no conflict of interest under CIRM’s policy.
Saira Ramasastry and Laurence Elias
Mr. Jensen cites two instances in which CIRM’s hired consultants in support of his claim that CIRM has “actual conflicts of interest.” In 2010, CIRM retained a partner at Life Sciences Advisory, LLC, Saira Ramasastry, to assist CIRM’s External Advisory Panel, which completed its work in December 2010. In 2012, Sangamo BioSciences, Inc., nominated Ms. Ramasastry to serve on its Board of Directors. Although Ms. Ramasastry continued to provide some consulting services to CIRM through fiscal year 2011-12, none of her work for CIRM involved Sangamo or any CIRM program in which it was involved. Ms. Ramasastry’s services on behalf of CIRM did not create any conflict of interest. The same is true of the second instance cited by Mr. Jensen. In 2010, CIRM hired Dr. Laurence Elias, a former Geron employee and an accomplished clinical development professional, to provide CIRM with technical and regulatory input to ensure that the clinical elements of an RFA were technically complete and accurate. The concept for RFA had already been approved and as such Dr. Elias was not in any position to influence the overall scope or structure, nor did he have any role in evaluating applications. CIRM staff and Dr. Elias complied with all conflict of interest requirements. Neither contract led to an “actual conflict of interest”.
Diane Winokur
Mr. Jensen’s laundry list of “conflicts” also includes a reference to the recent appointment of Diane Winokur to serve on CIRM’s Board. Mr. Jensen quotes a representative of the ALS Association who said that Ms. Winokur will be “a tremendous asset in moving the ALS research field forward through CIRM funding." Of all the insinuations made in his blog this is perhaps the cheapest shot, taking aim at a woman who has dedicated her life to fighting a deadly disease, one that claimed the lives of her two sons. Mr. Jensen knows very well that the ALS Association does not speak for Ms. Winokur or CIRM and while we expect that Ms. Winokur will bring her expertise as an advocate for people suffering from ALS to the Board, she, like all members of CIRM’s Board, represents all Californians, not just those suffering from a particular disease. Ms. Winokur’s appointment does not create a conflict of interest.
Press Releases
Finally, Mr. Jensen cites a Board debate from 2006 involving a requirement in CIRM’s intellectual property regulations regarding press releases. Under Health and Safety Code section 125290.30(g)(1)(C), the discussion of standards does not create a conflict of interest, and the Board’s debate was enriched by the participation of members who brought their expertise and experience to bear.
Mr. Jensen says that one of the reasons why the IOM did not report any instances of conflict of interest in its report is that it did not look for any conflicts of “inappropriate behavior,” But Mr. Jensen was present in the public hearing at UC Irvine in April of 2012 when the IOM panel asked Stuart Drown, Executive Director of the Little Hoover Commission that also looked into allegations of conflict of interest at CIRM, if he could cite any actual instances. Mr. Drown said he could not. Nor did Mr. Jensen offer any when it was his turn to talk.


The view from the California Stem Cell Report:
Generally speaking, CIRM's response about “actual” conflicts of interests is a reiteration of what the California Stem Cell Report carried at the time of each incident and does not add much new to the discussion of the issues. All of the agency's earlier responses could be found in the links in the “debunking” piece. Additionally the agency confuses what are clearly actual conflicts with other instances that could involve either actual or perceived conflicts, which the IOM noted can be as deadly as the real thing. However, in the most egregious cases involving Reed and later the five medical school deans, the agency would like the public to believe that these were not serious matters because the staff detected and caught the conflicts before the grants were made.
That is like saying a burglar who was caught in the act before he escaped with his booty committed no offense.
The acts were committed by members of the CIRM board, and they were violations of conflict of interest standards. In the case of the five deans, that is why the agency voided 10 applications totaling $31 million from their five institutions. If there had been no actual conflict of interest, that would not have been necessary.
As for blaming the staff for “miscommunications,” the applications that the five deans signed were quite clear and offered them the option of having another person at their institution sign the grant proposal. Other deans on the board did not sign applications in the same round. Those applications were then handled in the normal fashion. One might ask how in the world could the head of a medical school who was also serving on the CIRM board NOT recognize a conflict of interest when asked to sign a request for cash from the board on which he served?
Regarding John Reed and his conflict of interest violation, both he and then CIRM Chairman Robert Klein have acknowledged Reed's actions were wrong. Klein, an attorney who directed the writing of the 10,000-word measure that created CIRM, advised Reed to contact CIRM staff to lobby on behalf of a grant that was approved by the board but was about to be denied by staff.(See here, here and here.)
CIRM's response contends that Reed's 6 ½ page letter was nothing more than “factual” information dealing with technical matters. That is hardly the case. In fact, Reed explicitly “emphasized” (Reed's word) that failing to comply with his letter would damage the future of the stem cell agency. Denial of the grant, he said, “will surely discourage clinical researchers from participating in the CIRM mission to advance stem cell therapies.”   
Reed's action was inappropriate, and the California Fair Political Practices Commission warned Reed about his actions. The journal Nature reported,
“California’s Fair Political Practices Commission (FPCC) decided that Burnham Institute President violated conflict-of-interest rules by writing a letter to the California Institute of Regenerative Medicine appealing a decision that an affiliate of his institute was ineligible for funding.”
The California Stem Cell Report's “debunking” piece went beyond "actual" conflicts to describe other instances where conflicts emerged. Readers can go back to the original links for all the details, but the cases of StemCells, Inc., and iPierian, Inc., are worth reviewing again. Both cases involve fund-raising efforts that ran into millions of dollars for the ballot measure campaign that created CIRM. The campaign was run by Bob Klein who later became the agency's first chairman, serving for six years and becoming something of a hallowed figure in stem cell circles. One of the principal jobs of a campaign manager is to raise the millions needed to run a successful statewide election campaign in California. It is common for members of the public to believe that major campaign contributors are rewarded later for their contributions. Whether that was the case in these instances, the reader must decide for himself or herself. But the appearance is less than salubrious for an agency that claims to have never seen an actual conflict of interest as it has handed out $32,000 an hour, 24 hours a day, seven days a week during the last six years.
The facts are that about 90 percent of the $1.7 billion awarded by the CIRM board has gone to institutions tied to present and past members of its governing board. The agency, however, does work hard to be sure legal conflicts do not arise during board action on grant applications, using a voting procedure that is so convoluted that the actual vote on nearly all applications is not even announced at board meetings. Sometimes the procedure means that only a handful of governing board members can participate in debate or vote. In the case of the five medical school deans, as the board struggled to deal with the fallout in 2007, only eight of the 29 members of the board could participate in the discussion because the rest had conflicts.
As for CIRM's comments about “insinuations” and “cheap shots” by the California Stem Cell Report, we naturally differ with that characterization. The case in point involved what the chief scientist for a patient advocate group said she expected as the result of a recent appointment to the board. The scientist's remarks were offered as example of the type of expectation and entitlement that can arise when governing board members must be picked from specific constituencies, as is the case with all 29 CIRM board members.

And as for my testimony at the IOM hearing last April, here is a link to my statement, which includes a discussion of conflicts of interest.  

Wednesday, January 23, 2013

Thomas' Plan to Meet the the Recommendations of the IOM

Jonathan Thomas, chairman of the California stem cell agency, presented the following plan today to the governing board of the agency to deal with recommendations of the Institute of Medicine. 

Tuesday, January 22, 2013

California Stem Cell Agency: IP and Sustainability Off the Table Tomorrow

The California stem cell agency says that tomorrow's meeting regarding the sweeping changes recommended by the Institute of Medicine (IOM) will not include discussion of intellectual property issues or proposals for the “sustainability” of the $3 billion enterprise.

In a memo to the governing board of the agency posted on its web site today, James Harrison, outside counsel to the board, said,
“The chairman (Jonathan Thomas) has conveyed his view that CIRM should maintain its existing policies regarding revenue sharing, pricing, and access. In addition, chairman Thomas is working on proposals to address the IOM committee’s recommendations regarding a sustainability platform, but it would be premature to discuss these proposals at this time. Therefore, we do not intend to devote significant time to either the intellectual property or sustainability platform recommendations. Instead, we hope to focus the discussion on governance issues and the application review process.”
The CIRM board begins a critical, two-day session tomorrow in Berkeley to consider the IOM's recommendations, which met initial resistance last month from a number of the agency's 29 board members. The recommendations would make major changes in the board and would mean some members would lose their seats, if the proposals were adopted without change.

The IOM also said that the board needs to overhaul its conflict of interest standards, declaring that “far too many” board members are tied to organizations that benefit from CIRM's largess. The agency has long been a target of criticism that it has conflicts of interests that were built in by Prop. 71, the ballot measure that created the program. Roughly 90 percent of the $1.7 billion that the board has awarded has gone to institutions that are linked to members of the agency's governing board, according to compilations by the California Stem Cell Report.

Arthur Caplan, a prominent medical ethicist at New York University, says that the IOM has concluded that CIRM's grant award process is “insular and somewhat incestuous.”

Harrison's document was long on the positive aspects of the blue-ribbon IOM study, which CIRM is paying for at a cost of $700,000. It was commissioned by the board in 2010 with the intent that it would be a springboard to another multi-billion dollar state bond measure, which requires voter approval. CIRM operates on money that the state borrows (bonds). The interest on the bonds will bring the total cost to taxpayers to roughly $6 billion. The financial arrangement is unusual for research funding and differs from federal funding, which is not based on borrowed cash. The CIRM bond money, however, will run out in less than four years. 

Harrison cited 10 points in which the IOM had praise for CIRM, points that few would differ with in any major way, even prior to the IOM study. Some might quibble, however, with a few of Harrison's effusive adjectives.

Significantly, Harrison did not present a fresh legal analysis that might have raised the possibility of constitutional objections to the IOM proposals. A memo from Harrison in 2009 was used by then CIRM Chairman Robert Klein to box in the board in connection with other, similar suggestions for changes at the agency. 

Harrison also disclosed that board's intellectual property (IP)subcommittee will examine the IOM's proposals on IP later and make recommendations. The IOM suggested, among other things, that CIRM modify its policies to bring them in line with federal law, which is not without its own controversies.

Tomorrow's session will be covered live by the California Stem Cell Report via CIRM's audiocast, which is available to the public, and we will file stories as warranted. The meeting begins at 10:30 a.m. PST. Directions for dialing into the audiocast can be found on the agenda for the meeting.


Monday, June 08, 2009

CIRM Responds to Report on Future Industry Funding

The California stem cell agency today commented on the item we posted concerning a statement by its president that it is considering funding its future with cash from the biotech industry.

Responding to a request for comment from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, said,

“I tried to post this comment twice and your system sent back error messages.

“Two things. We heard the concerns regarding an industry advisory group and that recommendation was removed from the latest draft of the strategic plan update that has been circulating internally the past few weeks. Second, regarding President (Alan) Trounson's musings with the Bloomberg reporter, how does 'in the long run' and 'may try' become 'is.'"

Regarding problems with posting comments, if any readers experience such difficulties, please let me know at djensen@californiastemcellreport.com. The blog is hosted by Google, which provides the templates and mechanism for posting comments. I am more than glad to take up problems with Google on behalf of our readers.

CIRM Eyeing Major Reliance on Industry Cash

The president of the California stem cell agency, Alan Trounson, says it is considering funding its future with money from the biotech industry.

The possibility of a state government agency relying on industry dollars raises significant and new conflict of interest questions concerning the $3 billion effort. CIRM's governing board is already filled with representatives from institutions that have received the bulk of its funding.

Trounson made his comment June 4 in an interview with Bloomberg News. He also told the financial news service that it “wants to get 10 to 12 new therapies into human testing within four years.”

Both the comment about industry funding and human clinical trials appear to be the first public remarks along those lines by CIRM officials. However, we presume that Trounson may have misspoken on the human clinical trials, although Bloomberg has not run a correction as of today (June 8). The Bloomberg article is being circulated nationwide via email by a variety of persons interested in stem cell research.

The stem cell agency, now the largest funding source in the world for human embryonic stem cell research, is unusual financially in California. CIRM relies on state bond funds for its operations and grants. That source of cash is not subject to cuts by the governor or the legislature, only the ability of the state to sell bonds.

CIRM was sold to voters in 2004 as a 10-year program. However, no sunset provision is in place for the agency. It does have a 10-year limit on its bond funding. We have been told that clock started running with the first issuance of its state bonds in 2007.

Here is how Rob Waters of Bloomberg wrote about Trounson's comments on biotech funding for CIRM,
“In the long run, the agency may try to use industry funding to continue operating once its $3 billion in state bond revenue is exhausted by the end of the next decade, he said.”
As far as we know, no California state department relies on donations from private industry for its funding. But CIRM has the unusual capability of creating a nonprofit agency, rare among state departments. A nonprofit could serve as a vehicle for channeling industry funds to CIRM.

CIRM has been edging closer to industry over the last year with the staff's proposed revision of its strategic plan calling for much tighter ties.

Trounson's comments about future reliance on industry funds casts a new and different light on all of the agency's current actions. Is a decision on a grant being made because it will enhance or harm future funding from industry? Will CIRM's standards for its research grants be altered because of the need to be friendly to an important biotech company or a top researcher tied to a biotech firm? Will CIRM create, as is proposed, a special “biotech advisory group” to help evaluate CIRM interaction with industry?

The advisory group is recommended in the revisions to the CIRM strategic plan and has already generated controversy, along with CIRM's direction away from basic research and towards efforts favored by industry.

(You can find CIRM's plans on industry linkages in the draft of the strategic plan, beginning on page 28.)

CIRM already has several representatives from industry on its 29-member governing board. One wonders what would be gained by creation of this new panel, except that it presumably could meet privately and discuss matters that might be deemed inappropriate for airing at board meetings, which are required by law to be public.

The question of the long-term outlook for CIRM came up last month a meeting of the Little Hoover Commission, the state good government agency which has drafted major recommendations for changes in CIRM's structure. The draft proposals suggested CIRM explicitly lay out its plans for sustainability or shutdown. Representatives from CIRM at that meeting did not respond to the comment.

The question of future funding is already on the agenda of the CIRM directors' Finance Subcommittee this Thursday. It would certainly seem that Trounson's comments are suitable for some discussion in that context. The public can take part in the meeting at a number of teleconference locations throughout the state. Their specific addresses can be found on the agenda.

As for Trounson's remarks on human clinical trials, we assume that Trounson was referring to the $210 million disease team grant round, the second largest in CIRM's history. The RFA calls for up to 12 grants with the objective that grantees file an investigational new drug application within four years of the start of the award. Those applications are one step along the way to human clinical trials.

We have asked Don Gibbons, CIRM's chief communications officer, if CIRM has any comment on Trounson's remarks to Bloomberg. We will carry any remarks if Gibbons responds.

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