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1.: CALIFORNIA STEM CELL PROGRAM STUDIED BY EFFICIENCY PROGRAM: First He From: Stephen Meyer

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1.: CALIFORNIA STEM CELL PROGRAM STUDIED BY EFFICIENCY PROGRAM: First He

Posted by: "Stephen Meyer" Stephen276@comcast.net stephen_meyer_stemcells

Sun Dec 7, 2008 12:30 pm (PST)

CALIFORNIA STEM CELL PROGRAM STUDIED BY EFFICIENCY PROGRAM: First
Hearing Report

"Be then as adversaries in law: strive mightily, but eat and drink
as friends." –William Shakespeare.

by Don C. Reed

November 20th was the first hearing in the Little Hoover Committee
process, beginning an in-depth study of California's stem cell
program.

How did I feel about it? Probably the way a survivor of the Titanic
shipwreck might feel, if he was out on the ocean again, and sees an
iceberg, just ahead.

First, by way of background, Senate Bill 1565 (Kuehl/ Runner) asked the
Little Hoover Commission (LHC, an efficiency organization) to study the
California stem cell program: to see (among other things) if the
governing board of experts was a conflict of interest. For instance,
there were representatives of colleges on the board; although they were
not allowed to vote on money which would go to their college, did their
presence on the voting board make it automatically corrupt?

The California court system had already spoken on that issue, saying:

"…by approving Proposition 71, the voters have determined that the
advantages of permitting particularly knowledgeable persons to decide
which research projects to fund outweighs any concerns that these
decisions may be influenced by the personal or professional interests of
those members, so long as those members did not participate in any
decision to award grants to themselves or to their employers."

SB 1565 had been vetoed by Governor Arnold Schwarzenegger, but the
Little Hoover Commission was going ahead anyway.

They have the power to do that, because, (like the California stem cell
program itself), the LHC is both part of the government, and also set up
in such a way as to shield it from changing political winds. To do its
job, each agency must maintain a high level of independence.

Thirteen commissioners now have the power to not only study and
criticize, but also to suggest changes in the greatest stem cell program
in the world—and offer laws to make those changes mandatory.

As I sat in the back of room 4203 of the Capitol building, I thought of
all the attacks California's program has had to weather, to get
where we are today.

Remember the endless assaults on stem cell research: from the Bush
Administration, the Republican party, the religious right, and anti-tax
forces. One law was actually passed in the GOP-controlled U.S. House of
Representatives to put advanced stem cell research scientists in jail
for ten years and fine them a million dollars-- a law President Bush
promised to sign if it reached his desk—and which was only blocked
after tremendous battles in the United States Senate. That law was
proposed four times.

California's stem cell program, voted into power four years ago, has
only been allowed to operate for about 20 months, delayed by a lawsuit
from ideological and anti-tax groups.

We were only able to go forward when Governor Arnold Schwarzenegger
authorized a state loan, funds to operate with until the lawsuits were
decided in our favor. At last, the California Institute for Regenerative
Medicine (CIRM) was allowed to begin to fund stem cell
research—accompanied by a seemingly endless stream of what I regard
as anti-CIRM legislation, so many different laws to limit our program it
was hard to keep track of them all, not to mention numerous audits,
reviews, and investigations.

Despite that ocean of icebergs, California's stem cell ship of state
had advanced—and now we faced what might be our greatest threat.

The first two speakers were Michael Klausner, Professor of Law, Stanford
Law School, and Ken Taymor, Executive Director, Berkeley Center for Law,
Business, and the Economy. I knew Ken Taymor; he comes to most of the
meetings: great big tall guy, looks like a basketball player.

Their testimony was primarily technical, and advisory.

Mr. Klausner said a large decision-making board (the ICOC has 29
members) is automatically less efficient because of its size.

I wondered how he felt about the United States Senate (100 members) or
the U.S. House of Representatives (435 members).

Ken Taymor stated that (with exceptions) the California Institute for
Regenerative Medicine had done an exemplary job on transparency: keeping
the public informed, and allowing involvement.

Both men were questioned exhaustively by the committee, given every
chance to say exactly what they wanted to say. For instance, after
Taymor made the "exemplary" statement, the question came:

What do you mean, the ICOC did an exemplary job of informing the public,
and then you immediately point out an instance where important
scientific deliberations are held in secret—is that not a
contradiction?

Taymore's answer: That tension describes the situation. On the one
hand the public is welcome to the overwhelming majority of meetings; on
the other, the scientific advisory board does hold portions of its
meetings "in camera" (private).

There was a lot like that, complicated questions and difficult answers.

Then came the critics: John Simpson, Director, Stem Cell Oversight and
Accountability Project, Consumer Watchdog: and Jesse Reynolds, Director,
Project on Biotechnology in the Public Interest, Center for Genetics and
Society.

Both men called for major changes in our program. They asked for a
reduction in the leadership board, (the ICOC) that it should be reduced
from its present 29 members to 15, and that all representatives of a
university or research institute should be removed, or at least not
allowed to vote.

They asked that our stem cell program be put under the control of
another state agency, with hire and fire powers over the board, and the
authority to take our funds away.

Our hard-won stem cell research money could be spent somewhere else???

Mr. Reynolds said:

"…the special funds for the CIRM should no longer be allocated in
a manner isolated from the budget review process… the large,
untouchable set-aside for stem cell research is out of place during
these difficult times."

John Simpson said he had not yet made up his mind on that issue
(allowing our funds to be removed), but felt it should be considered.

Both men commented that as President Obama had pledged to remove the
Bush restrictions, and to double the NIH budget, there would now be
plenty of money. (Hold that thought, please).

But then I noticed something: small but important.

One member asked Mr. Simpson if one of the reforms he suggested was
practiced by the National Institutes of Health. There was a substantive
pause, after which Simpson answered honestly.

"No".

Something clicked in my worrying brain.

The Commission was not automatically buying the objectors' case.

One of the critics talked about putting the California stem cell program
under a separate agency-- but the Chair pointed out that would require a
Constitutional amendment. (Which did not mean it was impossible, but
more difficult than a simple legislative change.)

It felt like they were really trying to understand the situation.

I have testified at hearings when the members had their minds made up,
and were just going through the motions; this was different.

The next two speakers were Susan V. Bryant, Vice Chancellor for
Research, University of California, Irvine, and member of the
Independent Citizens Oversight Committee (ICOC), and Ralph O'Rear,
Vice President, Facilities and Planning, Buck Institute for Age
Research;

Remember that statement earlier about how there was going to be plenty
of money from the Federal Government for research, now that a more
understanding President was coming aboard?

Ms. Bryant pointed out, even if President-elect Obama doubled the NIH
funding, (which must be done—DR) that would only raise the money
available to embryonic stem cell research from $40 million to $80
million—no substitute for California's roughly $300 million a
year.

Ralph O'Rear talked about new companies opening up in California,
and young scientists were able to find funding in the Golden State. He
said that since Prop 71, scientists were no longer afraid of stem cell
research because of political worries, but were instead excited about
the new possibilities.

He contrasted that with the sad situation at the NIH where five years of
flat funding has meant more and more caution about giving grants, which
favors the older and established scientist-- the average age of a
scientist getting a major NIH grant is now about forty-three years old,
dashing the hopes of young researchers. This must change, and California
is part of the needed improvement.

Then it was the turn of Robert Klein, Chairperson, Independent Citizens
Oversight Committee and Alan Trounson, President of the California
Institute for Regenerative Medicine.

Why was there such a large board?

Many specialized viewpoints were needed.

What would he (Bob) do differently, if he had to re-write Prop 71 again?

Bob asked to confer with the ICOC on that one. It was such an important
question, he said. It was his style to lead by consultation.

I remembered all the meetings he chaired, and how nothing was decided
until everyone—public as well as board member—had ample
opportunity to say their say. This was why more decisions passed
unanimously, or close to it, because they worked carefully and
inclusively.

Chairman Daniel Hancock of the LHC asked Bob Klein if he had
"benefited personally in any way" from his work as Chair.

Bob said no.

Then, when Mr. Hancock indicated he wanted more information, the
chairman of the ICOC gave a more full answer:

If my memory serves, Bob said he had donated $6.5 million to the
campaign to pass Proposition 71. He held no stem cell or biomedical/life
science stocks, having voluntarily divested himself of anything like
that, when he took the job as chair. He worked without a salary for the
first four years, but that would have to change, in the economic times
at present.

But for me the most telling point was that Bob (a real estate man) had
written and helped implement the California Housing Finance Authority,
which provides loans for low income housing. Klein's own company
develops low income housing, which would seem to be an automatic
conflict of interest. He could have used his knowledge and position to
benefit his company and himself-- but in all the decades of that
program's existence, he had never taken a single grant or loan from
it.

Questions flew, and at last came one I was waiting for:

"Did I hear correctly, that the ICOC leveraged $272 million of
taxpayer money-- into $1.15 billion in purchasing power?" said
Little Hoover Chairman Daniel W. Hancock.

Bob said yes: by requiring matching funds from institutions wanting
facilities grants (buildings and equipment) an additional $880 million
had been brought to the table.

And then—did my ears deceive me? The chair said something like:

"That's A+ work on leveraging. It will be good to study this
public/ private partnership. It might be a good test case for how the
state might work."

He asked Bob to write more about leveraging and how it worked.

There was a lot more—Bob said how even a small improvement in the
costs of treatment for a few incurable diseases would pay for the whole
program. Trounson added that the main payment is cures for our loved
ones.

What about the international cooperation with Japan that was just
announced? President Trounson answered, talking about the growing number
of countries—countries!—that are entering into research
agreements with California, bringing hundreds of millions of more
research dollars to add strength to our efforts.

Regulations? The California system has an unprecedented level of
oversight, exceeding National Institutes of Health standards in many
cases, and our standards are held up as examples to imitate.

Was the board "hamstrung" by absences, and an inability to find
a quorum, as the critics implied?

Bob mentioned that one ICOC member's child has autism, and that it
is sometimes very difficult to get to meetings; also, some of our
patient advocates for disease have that condition themselves, and health
issues get in the way. But a new policy was being worked out where a
small number of members could be allowed to telephone in to meetings.
(That policy, consideration for which was begun in August, has since
been approved.) Even so, there had been a quorum at all 30 of the major
ICOC meetings.

To me, the real answer is the action accomplished, that decisions were
made and funds were awarded, so the researchers could to do the most
important work of their lives-- that is a decidedly un-hamstrung ICOC.

Both men spoke about the continuing need for cooperation with Assembly
and Senate in Sacramento: pointing out that our legislators' input
has helped shape California's stem cell research policies, every
step of the way.

He mentioned the hoped-for human trials on embryonic stem cell therapy
for spinal cord injury—I wanted to raise my hand and say,
"Originally funded by the Roman Reed Act, named after my
son!"—but restrained myself, with some difficulty.

Speaking on behalf of the patient advocates were Judy Roberson, Herb
Meyer, Susan Rocci and Raymond Barglow—each brought a different
perspective to the issue at hand. Each was an effective speaker for our
cause.

Karen Miner did not come because her wheelchair broke.

Bill Remak was ready to come, but in our conversation about travel
arrangements, he mentioned that last week he had broken both collarbones
in a car crash. I said no, Bill, even for you, there has to be limits.

But he sent a letter of public testimony anyway, saying, in part:

" …We feel that the intent and language of proposition 71
clearly defined the purpose of the program and created a transparent
system where the consumers of successful outcomes from the investments
in research would have a voice, thus keeping separate any political
influence from having an impact on the decision making of the
committee…

We do not wish to see this changed in any way.

…As a member of consumer and disease organizations that represent a
constituency of over 16 million Californians, I respectfully ask the
Commission to reject any recommendation that will suggest a change in
the mandate and governance that already exists.

Sincerely,

Bill Remak, B.Sc. MT, B. Public Health, SGNA

Chairman, California Hepatitis C Task Force

Chair, National Association of Hepatitis Task Forces

Executive Committee, California Chronic Care Coalition

Board Member, FAIR Foundation

My overall impression of the meeting? A huge sigh of relief.

The Little Hoover Commission's investigation will be lengthy and
thorough; I will be involved as much as I can. Naturally, I volunteered
to serve on any committees for which I might be eligible. Anything which
concerns our stem cell program is of tremendous interest to me, and I
want to help, making sure our side is fully considered.

There will be several small meetings up and down the state in the next
few months. I will let you know when they happen, (or look up Little
Hoover Commission on the web, and click on CIRM meetings—you can
also sign up to receive email notification) and you can attend, and be
part of this important work.

But I think the LHC will work to make it fair. Our state has a right to
be sure every dollar is carefully and wisely spent.

Besides, the California stem cell program should be studied, to be
learned from. If I had my way, every state would have something
similar.

If they find areas to improve, experience shows what will happen. The
ICOC will wrestle with the criticism, agonize and argue over it, and
then figure a way to make change where change is needed.

And as the LHC takes an in-depth look at the California stem cell
program,

I have a pretty good idea what they will find:

Something shining: which benefits California, our nation, and the
world—and that is worth defending.

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