The effort to place a $5.5 billion stem cell research initiative on the November ballot hit a key milestone this week, chalking up at least 25 percent of the signatures needed.
In an interview yesterday with the California Stem Cell Report, Robert Klein, chairman and founder of Americans for Cures, said that he expects to have about one million signatures in hand by the end of April.
To be be placed before voters, the initiative must have valid signatures from 623,212 voters. To achieve that number, many more signatures are gathered because a number of them are disqualified by elections officials. The deadline for signatures for the measure is June 15.
Klein sounded optimistic about the pace of the signature-gathering effort. He said it was running slightly ahead of 2004 when he led the effort for the ballot measure that created the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known.
"We're gaining momentum actually," Klein said in a phone interview.
CIRM needs a major cash infusion this year because it is running out of money. The agency was provided with $3 billion in bond funding by voters 15 years ago. It is now down to $27 million for research awards.
Klein sent a letter Feb. 1 to the California secretary of state, the state's top election official, declaring that the effort had acquired at least 25 percent of the signatures needed. The milestone triggers legislative hearings on the initiative.
The hearing or hearings must be held no later than 131 days before the Nov. 3 election. The legislature cannot alter the proposal, but it can offer its own version. Supporters of a proposed measure can also withdraw it.
"This means the legislature can offer alternative legislation as a compromise in an effort to convince petitioners to withdraw certified initiatives," according to Ballotpedia.
Klein declined to discuss specific costs of the signature gathering effort. However, it is largely done in California through firms that are paid by a measure's supporters. In 2018, the average cost of a signature was about $6.00 and ran as high as about $9.00, according to Ballotpedia. The average total cost in 2018 was $2.6 million for qualifying an initiative.
Klein is a real estate developer based in Palo Alto. He directed the writing of both the original initiative and the latest one and was the agency's first chairman. Americans for Cures is the stem cell advocacy group that he founded.
(The information on costs of signature gathering was not contained in an earlier version of this item.)
Wednesday, February 05, 2020
Tuesday, February 04, 2020
California's Stem Cell Agency Considers Mounting Major Public Forum During Upcoming Ballot Campaign for $5.5 Billion in Refinancing
California's stem cell agency has recovered $2.3 million from unsuccessful research awards and today proposed to split the amount between more research and a public forum later this year to discuss progress in the field.
The forum would be held after a proposed ballot initiative to refinance the agency with $5.5 billion is likely to have qualified for the November ballot. The proposal for the two-day event is the sort of conference that opponents of the agency are likely to raise questions about.
Legal restrictions exist in California exist concerning how public funds may be used during a ballot campaign. In response to a question, a spokeswoman for the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said this morning that the grantee conference would comply with state law and would not involve advocacy for the ballot initiative.
The proposal, if approved by voters, would save CIRM from financial extinction. The agency is running out of money and needs more billions to continue its work. CIRM was created in 2004 by voters who provided $3 billion in state bond funding. It is now down to $27 million for awards.
At its meeting on Thursday, the CIRM governing board is scheduled to be asked to allocate $1.8 million of the recovered funds for "progression" awards to help advance more basic level research into possible clinical use. A CIRM document said that two applications have already been received and another six appear to be in the pipeline.
Another $250,000 would be allocated for a public conference in the latter part of the year "to discuss advances and progress in the field of stem cell research in California."
The event would occur after the proposed initiative qualifies for the ballot. Efforts to gather more than 600,000 signatures of registered voters are already underway. The deadline for qualification falls in June.
State law bars agencies from spending public funds for activities that are strictly for ballot campaigns. However, the agencies are permitted to continue their regular public information practices.
James Harrison, former general counsel to the agency and a well-known expert on campaign law, briefed the CIRM governing board last fall on the complex restrictions and gray areas. He said,
In response to a query from the California Stem Cell Report, Maria Bonneville, a spokeswoman for the agency, said,
The forum would be held after a proposed ballot initiative to refinance the agency with $5.5 billion is likely to have qualified for the November ballot. The proposal for the two-day event is the sort of conference that opponents of the agency are likely to raise questions about.
Legal restrictions exist in California exist concerning how public funds may be used during a ballot campaign. In response to a question, a spokeswoman for the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said this morning that the grantee conference would comply with state law and would not involve advocacy for the ballot initiative.
The proposal, if approved by voters, would save CIRM from financial extinction. The agency is running out of money and needs more billions to continue its work. CIRM was created in 2004 by voters who provided $3 billion in state bond funding. It is now down to $27 million for awards.
At its meeting on Thursday, the CIRM governing board is scheduled to be asked to allocate $1.8 million of the recovered funds for "progression" awards to help advance more basic level research into possible clinical use. A CIRM document said that two applications have already been received and another six appear to be in the pipeline.
Another $250,000 would be allocated for a public conference in the latter part of the year "to discuss advances and progress in the field of stem cell research in California."
The event would occur after the proposed initiative qualifies for the ballot. Efforts to gather more than 600,000 signatures of registered voters are already underway. The deadline for qualification falls in June.
State law bars agencies from spending public funds for activities that are strictly for ballot campaigns. However, the agencies are permitted to continue their regular public information practices.
James Harrison, former general counsel to the agency and a well-known expert on campaign law, briefed the CIRM governing board last fall on the complex restrictions and gray areas. He said,
"Communications about a ballot measure should be delivered through CIRM’s ordinary communication methods, like its website, blog, newsletter, emails to interested persons, and public meetings, in the style CIRM normally uses to communicate other information. CIRM should avoid passionate or inflammatory language and modes of communication that it does not regularly employ, and should not encourage voters to vote in a particular manner."Harrison drafted portions of the 2004 initiative that created the agency. He was also heavily involved in drafting the current proposed initiative.
In response to a query from the California Stem Cell Report, Maria Bonneville, a spokeswoman for the agency, said,
"CIRM has conducted four grantee meetings since the agency’s inception. These meetings are opportunities for grantees to share information about their progress, discuss bottlenecks in the field, and identify potential partnership opportunities. This grantee meeting will be no different. The meeting will comply with state laws governing the use of public funds in connection with ballot measure campaigns and will not include any advocacy for or against the ballot measure."The CIRM conference proposal said that the public, CIRM grantees, interested funding organizations, patient advocates and stakeholders would be invited to the two-day session. An estimated 300-400 participants are expected. CIRM said the goals of the meeting are to:
- "Provide a public forum to learn about the most recent advances in stem cell research in California.
- "Encourage the sharing of information and data among CIRM grantees to foster collaboration and learning.
- "Timely presentations to address and overcome key bottlenecks and challenges in the field to help advance existing projects.
- "Showcase promising stem cell-based projects for partnership opportunities with investors, funders, or companies"
Monday, February 03, 2020
California's New Stem Cell Initiative and Its $7.8 Billion Cost, Including Interest
The price tag for refinancing California's unique and ambitious stem cell research program could run to close to $7.8 billion, give or take a few hundred million dollars or more.
So says the state's legislative analyst in a financial analysis of a proposed ballot initiative that is likely to be on next November's ballot. The measure would provide $5.5 billion more for research awards to California scientists by the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.
The increase in the price tag is caused by the fact that the $5.5 billion would be borrowed money -- bonds that would be issued by the state. The legislative analyst estimated that the interest costs could total $2.3 billion, bringing the actual expense to taxpayers to $7.8 billion.
Significant caveats exist, however. The legislative analyst, who prepares these sorts of analyses for all ballot measures, cautioned that the $7.8 billion estimate could rise or fall depending on how interest rates rise or fall. Another unknown involves the length of the payback period.
What the legislative analyst has to say is a significant matter for the proposed initiative, whose success will determine the financial survival of the agency. CIRM is running out of cash. It was funded by voters 15 years ago with $3 billion. If the proposed initiative fails, CIRM will wither away over the next two to three years.
Should the initiative qualify for the ballot, the seven-page financial overview of the measure would be delivered, via the state's official voter's guide, to about 20 million California voters prior to the election. The overview would also serve as the basis for news stories in virtually all of the media, which is always looking for bottom line figures.
Beyond the interest costs, the analysis carried other financial bits of interest. It said that over an initial, five-year period the agency would use some the bond proceeds to pay the interest on the money it is borrowing. The analyst said,
The new initiative stipulates that the agency improve access to stem cell therapies, funding that effort with up to 1 percent of the $5.5 billion, a change from the current law involving CIRM. Other changes from the current situation: 1.5 percent for starting "community care centers" for new clinical trial sites, $1.5 billion for research into brain and nervous system diseases and up to 0.5 percent for a shared lab program.
Royalties from any therapies financed by CIRM research would go to the agency and not the state general fund, as currently is the case. So far, royalties have totaled only about $200,000. Larger amounts are likely to appear in the next decade as the therapies emerge from the research that was financed years ago.
Regarding possible savings as the result of more cost-effective therapies, the analysis said,
In 2004, the legislative analyst prepared an interest cost estimate of $3 billion on the original amount for awards, also $3 billion. However, the projections did not anticipate the recession of 2008, which resulted in a long-term drop in interest rates. Today, the interest on the original $3 billion is expected to be about $1 billion.
Here are links to more information on proposed initiative and related matters:
So says the state's legislative analyst in a financial analysis of a proposed ballot initiative that is likely to be on next November's ballot. The measure would provide $5.5 billion more for research awards to California scientists by the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.
The increase in the price tag is caused by the fact that the $5.5 billion would be borrowed money -- bonds that would be issued by the state. The legislative analyst estimated that the interest costs could total $2.3 billion, bringing the actual expense to taxpayers to $7.8 billion.
Significant caveats exist, however. The legislative analyst, who prepares these sorts of analyses for all ballot measures, cautioned that the $7.8 billion estimate could rise or fall depending on how interest rates rise or fall. Another unknown involves the length of the payback period.
What the legislative analyst has to say is a significant matter for the proposed initiative, whose success will determine the financial survival of the agency. CIRM is running out of cash. It was funded by voters 15 years ago with $3 billion. If the proposed initiative fails, CIRM will wither away over the next two to three years.
Should the initiative qualify for the ballot, the seven-page financial overview of the measure would be delivered, via the state's official voter's guide, to about 20 million California voters prior to the election. The overview would also serve as the basis for news stories in virtually all of the media, which is always looking for bottom line figures.
Beyond the interest costs, the analysis carried other financial bits of interest. It said that over an initial, five-year period the agency would use some the bond proceeds to pay the interest on the money it is borrowing. The analyst said,
"Were the state to begin issuing bonds shortly after approval of the measure, CIRM would likely make interest payments totaling in the low hundreds of millions of dollars from bond proceeds by the end of 2025."The proposed initiative also places a 6.5 percent cap on total funding for certain operational expenses including administration and grant oversight. Other changes would give more freedom to the agency, which originally had a 50-person cap on staff. That cap was later removed by state legislation. The new initiative would set the cap at 70 with a provision for more employees beyond that number, under certain conditions involving, among other things, compensating them with cash raised privately.
The new initiative stipulates that the agency improve access to stem cell therapies, funding that effort with up to 1 percent of the $5.5 billion, a change from the current law involving CIRM. Other changes from the current situation: 1.5 percent for starting "community care centers" for new clinical trial sites, $1.5 billion for research into brain and nervous system diseases and up to 0.5 percent for a shared lab program.
Royalties from any therapies financed by CIRM research would go to the agency and not the state general fund, as currently is the case. So far, royalties have totaled only about $200,000. Larger amounts are likely to appear in the next decade as the therapies emerge from the research that was financed years ago.
Regarding possible savings as the result of more cost-effective therapies, the analysis said,
"To the extent the measure results in new treatments that are more cost-effective than existing treatments, state and local governments could experience savings in some programs such as Medi-Cal, the state’s subsidized health care program for low-income people. The magnitude of these and other indirect effects is unknown."The stem cell agency, which was created by voters in 2004, has yet to finance research that has led to stem cell treatments that are approved for general public use.
In 2004, the legislative analyst prepared an interest cost estimate of $3 billion on the original amount for awards, also $3 billion. However, the projections did not anticipate the recession of 2008, which resulted in a long-term drop in interest rates. Today, the interest on the original $3 billion is expected to be about $1 billion.
Here are links to more information on proposed initiative and related matters:
SUNDAY, DECEMBER 08, 2019
LA Times: $5.5 Billion Measure for California Stem Cell Agency Could Actually Be a 'Downfall'
FRIDAY, NOVEMBER 15, 2019
$5.5 Billion Stem Cell Ballot Measure: Questions in California but Apparently No Foot-Dragging
MONDAY, NOVEMBER 04, 2019
California Stem Cell Agency Chalks Up its 60th Clinical Trial as Funds Dwindle
Thursday, January 30, 2020
Federal Stem Cell Regulation Setback in California; Case Involves Treatments with Fat Cells
Dubious stem cell clinics in California were in the news again this week with a piece in the Los Angeles Times declaring that a federal judge had dealt a blow to regulators trying to crack down on the much-criticized enterprises.
The column by Michael Hiltzik said,
The column by Michael Hiltzik said,
"A Los Angeles federal judge has rejected a government motion that could have shut down a network of clinics offering customers allegedly unauthorized stem cell treatments.
"The ruling by Judge Jesus G. Bernal potentially deals a setback for the Food and Drug Administration’s campaign against treatments using stem cell preparations that the FDA has not approved.
"In the ruling published late Monday, Bernal denied the government’s motion for summary judgment in its lawsuit against the Rancho Mirage-based California Stem Cell Treatment Center, the Cell Surgical Network, and the latter’s founders, Mark Berman and Elliott Lander. Bernal ruled that the case was suitable for trial."UC Davis stem cell researcher Paul Knoepfler also wrote about the case on his blog.
"The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of the medical science here as a stem cell biologist.
"Unfortunately, this all leaves the door potentially still open for hundreds of clinics to sell the unproven fat stem cell product at the heart of this case called 'stromal vascular fraction' or (SVF)."
This lawsuit was first filed in May 2018 and is likely to continue for some time, possibly involving lengthy appeals.
The controversy over unregulated clinics is of concern to those who support refinancing California's stem cell agency with $5.5 billion via a hoped-for voter approval of a ballot measure in November. The fear is that the flap could create voter confusion and besmirch the entire field.
The agency was created in 2004 by voters who provided it with $3 billion. It is now down to its last $27 million for research grants. That figure is likely to increase next week as agency directors hear a report on the amount of cash recovered from awards that did not meet benchmarks.
Monday, January 27, 2020
Calfornia's Stem Cell Pie for 2020: State Agency to Slice Up Nearly Final Millions Next Week
It ain't over yet -- at least that's the word from what could be deemed the financial center of stem cell research in California.
The governing board of the California stem cell agency is scheduled to meet Feb. 6 to allocate unspecified additional millions for stem cell research and peer down the road that awaits it beginning Nov. 4 of this year.
That is the day after California voters are expected to deliver their judgment on whether the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, should continue and receive an additional $5.5 billion.
The agency is running out of money. Its initial $3 billion is now down to $27 million for awards. A ballot initiative to give the agency the additional billions is expected to be on the ballot this fall, Nov. 3 to be precise.
But in just 10 days, the CIRM board will reveal the amount of cash that has been recovered from research awards that failed to meet milestones during 2019. The board is scheduled to make decisions on how that money, which is likely to run into tens of millions, is to be allocated during the remainder of this year.
Also on the agenda is a three-word topic: "strategic plan themes." This is likely to involve possible directions of the agency should it receive additional funding from the ballot initiative. That proposed measure substantially expands the scope of the agency and specifies it move into in certain new areas, including attempting to assure the affordability of agency-financed therapies whose costs could run upwards of $2 million.
The agenda includes an update on most major programs involving CIRM, information that will come widely into play as the next fall's election receives more attention.
The meeting will be based at CIRM's headquarters in Oakland. But it will also be available electronically at a number of other public locations throughout California and via the Internet. Members of the public will be able to comment and ask questions through the Internet. Details are available on the agenda.
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