Proposition 14, the fall ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion that it is seeking from the state’s voters.
Added to the agency’s charter would be research involving mental health, “therapy delivery,” personalized medicine and “aging as a pathology.“ That is not to mention a greater emphasis on supporting “vital research opportunities” that are not stem cell-related.
The measure would enlarge the board from 29 to 35 members. Even at 29, the board has been much criticized for its large size, which creates more possibilities for conflicts of interest, a long-standing issue for the agency.
The measure locks up $1.5 billion for “diseases and conditions of the brain and central nervous system,” such as autism and schizophrenia.
Proposition 14 would ban royalties generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers.
It creates a building program for treatment centers that could total about $82.5 million. They would be located in areas not now well-served. And the measure locks up $1.5 billion for “diseases and conditions of the brain and central nervous system,” such as autism and schizophrenia.
Approved by voters in 2004, the agency is already a prodigiously ambitious effort, seeking stem cell cures and treatment for afflictions that backers say burden half the families in California. However, the original $3 billion that voters provided is dribbling to an end. And unless voters provide $5.5 billion more, the agency — known officially as the California Institute for Regenerative Medicine (CIRM) — will begin shutting its doors this winter.
While Proposition 14 is the cure for what financially ails the agency, the measure also sends CIRM into arenas that some would argue muddle its focus and distract from its original goals.
The intent is to create and build support for financial models for health insurance companies. CIRM would also be charged with helping to implement them.
Details of the changes in CIRM’s mission are tucked away in the complex and murky, 10,000-word initiative sponsored by Robert Klein, a Palo Alto real estate developer and attorney. He oversaw the writing of the initiative as well as the 2004 stem cell measure that created the agency. Klein was the first chairman of the agency and is now leading the current campaign.
(Note, click here to see the Legislative Analyst’s description of the measure, which is going to nearly 21 million California voters )
The new playing field for CIRM encompasses particularly critical areas of costs to patients and profits for companies. Stem cell therapies are expected to be enormously expensive — $1 million or more in many cases. That’s a figure that makes health insurance companies balk and Medicare blanch.
Proposition 14 would launch a hefty effort to make stem cell therapies more affordable and accessible. The cash behind that drive could run as high as $155 million. And that’s not necessarily going for patients.
The intent is to create and build support for financial models for health insurance companies. CIRM would also be charged with helping to implement them. Such models would justify the cost of the theoretically one-time cures by demonstrating that they would actually save money — ending the need to treat patients in what currently seems to be an endless and expensive cycle.
Proposition 14 speaks of covering patients and, importantly, their caregivers for medical expenses, lodging, meals and travel. That would help provide access to clinical trials that are located in prohibitively expensive urban areas, which poses financial barriers for persons who live some distance away. The added coverage would additionally help researchers and companies recruit enough trial participants, which can be a problem in some disease areas.
The affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.
The extraordinary cost of stem cell treatments involves something called “reimbursement,” a biomedical industry euphemism for how companies cover the high costs of the research and still make a profit. If money is not to be made, businesses are not likely to be motivated to turn CIRM research into cures.
Proposition 14 creates a 17-member, CIRM affordability committee to drive all this. It would work with industry and the federal government to win their support. The committee would be backed with as many as 15 CIRM staffers. The ballot allows as much as $55 million for their compensation over 10 or so years.
But if 15 is not enough, more employees could be hired beyond the nominal cap on CIRM employees of 70 if they are compensated through the use of private cash.
The measure additionally allows the new affordability panel to hire consultants, capping that expense at about $105 million.
The affordability effort involves important public policy, industry and research issues that concern patient groups and industry. However, the affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.
Votes by the committee, however, would have to be taken in public.
Members of the panel would not be required to disclose publicly their economic or professional interests. The committee would be exempt from the state public records act except for material specifically submitted to the CIRM board.
Known as “vital research opportunities,” VROs are a loophole that allows CIRM to finance almost any kind of research if there are enough votes on the board to do so.
Beyond the affordability program, Proposition 14 gives CIRM new authority to finance research in several additional fields. The authorization is scattered throughout the initiative document. Mental health research first appears on page nine. Depression appears on page 26. Therapy delivery, which is not defined in the measure, crops up in 10 locations. Personalized medicine and “aging as a pathology” surface on page 34.
Proposition 14 locks up $1.5 billion for “diseases and conditions of the brain and central nervous system, such as Alzheimer’s disease, Parkinson’s disease, stroke, dementia, epilepsy, depression, brain cancer, schizophrenia (and) autism.” The $1.5 billion would not be available for research into the No. 1 killer in the United States, heart disease, or other excluded conditions.
On a much smaller scale, but important to researchers, the proposition includes up to $27.5 million for a shared labs program that was scrubbed a few years back when CIRM turned more towards clinical trials. And the initiative opens the door to even more programs that are not specifically mentioned. It gives a high priority to supporting pluripotent stem cell research that is unlikely to receive federal funding or where funding is “not timely or sufficient.”
Perhaps the biggest, but not entirely new opportunity for CIRM to expand beyond stem cell research involves “vital research opportunities.” CIRM calls them VROs. And they are a loophole that allows CIRM to finance almost any kind of research if there are enough votes on the board to do so.
In both the original and current initiative, a VRO is defined as “scientific and medical research and technologies” that provide “a substantially superior research opportunity, vital to advance medical science.”
In the 2004 initiative, the phrase “vital research opportunities” appeared only seven times. In this year’s initiative, it appears 17 times…
Proposition 14 specifically added the fields of “qenetics, personalized medicine, and aging as a patholoqy” to VROs. In the 2004 initiative, the phrase “vital research opportunities” appeared only seven times. In this year’s initiative, it appears 17 times as the possibility of its use has expanded. Significantly, experience involving vital research opportunities is now listed as part of the qualifications for the chair, two board members and 15 members of the group that reviews grant applications.
Proposition 14 makes it easier for the CIRM board to declare a VRO. Currently, it takes a two-thirds vote of a quorum of the group that reviews applications. Under this year’s ballot measure, CIRM does not need to meet those criteria. The governing board could invoke a VRO on its own. In some cases, it could require only 12 votes or less of the 35-member board, depending on the quorum and the number of board members present.
CIRM has invoked the original VRO clause only twice. A third attempt was rejected last May after directors expressed concern about mission creep. However, Klein’s new emphasis on it points to the likelihood of increased use, especially if he once again becomes chairman of CIRM.
Under Proposition 14, the royalties would still go into the general fund, but they would be locked up for use in dealing with affordability.
In 2004, the stem cell campaign financed studies that envisioned royalties of as much as $1.1 billion. To date, they have totaled only $462,433. However, it can take years for a scientific discovery to work its way into an actual product. And a particular discovery may well amount to only a tiny contribution to a product, which would reduce the likelihood of major royalties.
Under existing law, CIRM’s royalties go into the state’s general fund, the source of state expenditures for prisons, schools and health services. Under Proposition 14, the royalties would still go into the general fund, but they would be locked up for use in dealing with affordability.
In another major move, Proposition 14 would benefit some of the less-than-urban areas of the state in a new “geographic diversity” program. Rural or semi-rural areas suffer from a lack of physicians as well as the high tech facilities needed to make stem cell treatments available for participation in clinical trials. The measure earmarks as much as $82.5 million for new “community centers of excellence.” They would “support clinical trials and…serve as the foundation for the delivery of future treatments,” the proposition states, giving priority to “geographic distribution.”
One of them could well be in Fresno where the University of California, San Francisco (UCSF), has established an outpost. One of the new members on the CIRM board would be from the UCSF operation in Fresno. Another new member of the board would be from UC Riverside, whose medical school is only seven years old. UC Riverside also serves a community that incorporates large rural and semi-rural areas.
Proposition 14 is something of a “Christmas Tree” measure — a term used to describe legislation that has something for everyone.
The increase in the size of the board to 35 flies in the face of recommendations by the prestigious Institute of Medicine (IOM). Among other things, it said in 2012 that the current 29 board members are more than sufficient for the agency. CIRM paid $700,000 for the IOM study, which it hoped would help generate voter support for more funding.
If Proposition 14 passes, the measure creates a relatively quick way to begin to overhaul the board. Under Proposition 14, some current members of the board could lose their seats if they have served at least half of their terms. Proposition 14 also contains holdover language from the 2004 proposition that would seem to require the selection of a new CIRM board chairman within 45 days after official passage of the measure. However, the general counsel for the agency says that the holdover language was effectively nullified by the technical way state law works and by a 2019 state Supreme Court decision.
It is not clear whether the CIRM governing board understood the removal provisions when they endorsed Proposition 14 June 26 on a 21-1 vote. The discussion lasted only 30 minutes. “It’s a no-brainer,” said George Blumenthal, chancellor of the UC Santa Cruz campus and a member of the CIRM board..
Proposition 14 is something of a “Christmas Tree” measure — a term used to describe legislation that has something for everyone. Many ballot initiatives are like that. They must run the gauntlet of a ballot campaign, luring millions of voters into voting for them. Backers of initiatives need to satisfy potential donors and potential beneficiaries, all the while not alienating anybody enough to generate well-funded, powerful opposition.
The 2004 measure fulfilled those needs nicely. Nearly every institution that stood to benefit from CIRM funding gained a seat at the table where the decisions were made — for better or worse. Proposition 14 carries on in that tradition and expands it. Plus the initiative attempts to deal with the tough challenges of costs and profits in what many expect to be a revolution in medicine. Voters will begin casting their ballots in early October. Backers of the initiative have only five weeks to catch the early birds in that particular flock.
Editor’s Note: CORRECTS and CLARIFIES initiative’s potential impact on CIRM’s governing board, 35th graf. David Jensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published more than 5,000 items on California stem cell matters. His upcoming book, “California’s Great Stem Cell Experiment: Inside a $3 billion Search for Cures,” is available for pre-order on Amazon.