Having brought in roughly one billion dollars in new money for the state, (more on that later) the California stem cell program is already a spectacular success.
But there are other and more personal ways to judge the California Institute for Regenerative Medicine (CIRM).
In 1966, my sister Patty Reed found out she had leukemia, and there was no hope. She told her boyfriend Nye Morton they should break up: her passing would be hard, and she did not want him to see her in pain. To Nye's everlasting credit, he said no, he felt just the opposite: if they only had a little time left, they should get married, and spend it every minute they had together. They did get married; and Patty was such a beautiful bride.
Eleven months later, she was taken from us at the age of 23.
Just a few years ago, a scientist named Catriona Jamieson of UC San Diego, was working on blood cancer stem cells, something called myeloproliferative disorders--which can lead to leukemia.
Politics got in her way. Dr. Jamieson needed a grant from CIRM--but the funding for California's new stem cell program had been delayed by lawsuits.
Fortunately, Governor Arnold Schwarzenegger was in office. It would have been easy for him to just sit by, take a wait and see attitude. Instead, with foresight and courage, he took a stand for stem cell research, authorizing an advance (since paid back) of $150 million against the initiative's bond authority.
Catriona Jamieson's research went ahead.
And today? Defying the usual slow pace of science, which often takes decades or centuries to solve problems, her CIRM-funded project has succeeded in preliminary human trials.
There is a long way to go, but leukemia is being chased down, and fought.
People like Patty Reed and Catriona Jamieson are why seven million California voters said yes to Proposition 71.
Unfortunately, another political obstacle has arisen.
Senate Bill 1064.
Carried by Senator Elaine Alquist, (D-San Jose) SB 1064 would rewrite the California stem cell program.
Her press release announcing SB 1064 began with a statement of support for the overwhelmingly popular state program:
"I was an early supporter of California's groundbreaking stem cell initiative, and know that our public investment on behalf of the State of California will lead to new frontiers of treatment to heal people with chronic diseases", said Alquist.
So far, so good.
But then it came -- she threw down her claim of justification: for a law which might delay or obstruct the medical advances California wants.
"... CIRM is essentially accountable to no one... By accepting public bond dollars, CIRM also accepted public accountability, public transparency, and a public return on their investment."
Accountable to no one?
"CIM has been audited by the Bureau of State Audits...(was) found to have met all accountability standards by the State Controller...(and) has had five years of clean financial audits by independent public accounting firms."--CIRM letter.
Add in the continuing oversight of the Governing Board, (the Independent Citizens Oversight Committee, or ICOC), the new external review just beginning, other independent studies, not to mention the massive documentation required by the two year lawsuit, and it becomes clear that CIRM has been audited so many times, it is difficult to keep track of it all. There are literally auditors auditing the work of the other auditors. Adding more would be like installing seventeen anti-virus programs into your computer, so many the computer gets confused and distracted and cannot do its job.
"...public transparency"?
By law, the California stem cell program makes all its decisions in public. Everyone is welcome, and may participate. (go to www.cirm.ca.gov, and click on "meetings".) About the only thing the CIRM insists on keeping private is the names of people and companies whose applications for grants are rejected. Why is this done? To protect their reputations. Publishing those whose projects fail to gain funding may damage their chances somewhere else.
And as for "public return"?
For starters, how many government programs bring in new money?
CIRM's construction budget was $270 million. However: the leadership negotiated with every institution wanting a grant. If a company or a college wanted California dollars to help build a stem cell laboratory, they had to compete for the opportunity by bringing other money to the table, which they did -- an additional $885 million -- every dime of which is being spent in California.
Who got that extra money for California?
The Chair of the Governing Board, Bob Klein, and the 28 other patient advocates, scientists, and doctors who oversee the program.
Under the terms of SB 1064, those negotiations would not have been allowed.
The new law would shift all such duties to one person, the President of CIRM, who would also be responsible for enforcing those policies.
SB 1064 would re-write the job descriptions of the President of CIRM and the Chair of the Governing Board, overburdening one and making a figurehead of the other. Their terms would be reduced to only four years, overlapping--so they would only have two years in which to work together, discouraging teamwork.
This is not what we asked for.
Seven million Californians voted for a carefully developed structure; the Governing Board and the Chairperson are to set policy and negotiate contracts: the CIRM President and staff propose the scientific vision and implement that vision under the oversight of the board.
This division of labor is clear, simple, straightforward; it works.
SB 1064 offers a long list of changes.
Let's look at two:
SB 1064 would require the Citizens Financial Accountability Oversight Committee, a political board, to do performance audits on the science.
Does that make sense, for politicians to evaluate the scientific goals and progress of the stem cell program?
Regenerative research science is complicated. That is why California law insists that every CIRM grant proposal be judged twice: first by scientists from out of state (to prevent conflicts of interest) on the Grants Review Board with its patient advocates, and then by the Governing Board in public meetings.
Should we trade that careful structure, for the guidance of non-experts?
Perhaps most damagingly, SB 1064 would impose a complicated system of price controls and licensing requirements, for products resulting (in whole or in part) from CIRM-funded research-- and demand that all revenues go into the General Fund.
There is a world of hurt in that sentence.
The goals are good: to provide access to therapy for everyone, and to give money to the California government.
But the method is flawed. If SB 1064 goes forward, both goals--access and revenues--are threatened.
One fact is crystal clear. We need the corporations to develop the products that will heal sick people. Without the involvement of private enterprise, neither therapies nor products will be developed. No patients will be helped; no new revenues will flow into the public coffers, and the greatest research in the world will be nothing more than empty talk.
To develop and test new medical therapies and products requires an investment of potentially hundreds of millions of dollars.
Is a company likely to accept such risk, if it is not assured of ownership of the product?
The Governing Board has been working on these issues since the beginning, and have come up with decent and caring approaches: ways to answer the need for financial return to the state without crushing out the progress of the research.
In addition to a graduated system of payments from companies that develop products, CIRM has also established a policy for access to new drugs, including provisions for public programs getting these drugs cheap.
As always, these policies resulted from state-wide conferences, public input, and consultations from every interested source.
"CIRM has already adopted extensive regulations to balance the opportunity for Californians to benefit from their investment in stem cell research while ensuring that the research is not impeded. These regulations include revenue sharing, access plans, and pricing preferences for public entities. (The) governing board adopted the regulation after extensive public hearings, a process that John Simpson of Consumer Watchdog has referred to as a model for making policy."--CIRM letter.
One question occurs to me, and it comes back to my family.
Before the leukemia struck, Patty was studying computers. She used to carry around stiff pieces of paper with holes punched in them, and she tried to explain to me about binary codes and things I did not understand--and that electronics was the wave of the future.
Of course, she was right. We all know what happened next. The computer revolutionized our lives, and San Jose, Senator's Alquist's home district, became Silicon Valley.
Think how many jobs were brought to San Jose, how many companies were founded, how many families were fed, how many tax dollars were generated.
Would that unparalleled success have happened if the fledgling new enterprise had been inundated by complicated new tax laws and hyper-regulations?
In all the world, California's carefully-structured stem cell program is unique. It exists to ease suffering, and save lives, through regenerative medicine. It should be allowed to fulfill the will of the voters, and to do its useful work, living by its motto:
"Turning stem cells into cures."
That motto, by the way, was chosen in a public meeting. It was written by my paralyzed son, Roman Reed.