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Category Archives: Stem Cells

Boxing in the California Stem Cell Board

Robert Klein is much admired for his
prodigious efforts on behalf of stem cell research, including his
service as the first chairman of the $3 billion California stem cell
agency.

Klein was adept at many tasks, such as
directing the ballot campaign that resulted in passage of Proposition
71
in 2004 and creation of of the agency. One of Klein's less
publicly recognized skills was putting the governing board of the
agency in a box from time to time.
The 29 members of that board could well
be headed for another box – this time in connection with their
position on the Institute of Medicine's sweeping recommendations for major changes at the stem cell agency.
Here is how that could work based on a
similar situation in 2009 involving Klein and the Little Hoover
Commission
, the state's good government agency.
Klein did not welcome the inquiry by
the commission, which was requested by state lawmakers who had butted
heads with Klein. He knew that the commission would come up with
recommendations that he would find odious.
So even before the Hoover report was
released in its final form, Klein had the board's outside counsel,
James Harrison, prepare a legal memo on a draft version of the study.
Harrison's memo said many of the most far-reaching recommendations of
the commission would require a vote of the people – a more costly
and unlikely proposition than a vote of the legislature.
Harrison's memo was dated June 23,
2009. The commission report was released June 26, 2009. On June 30, 2009, Klein warned directors in an email that support of some of the
proposals would violate their oath of office. The first time a
subcommittee of directors had to a chance to react publicly came on
July 16, 2009. The full board did not have the Hoover report on its
agenda until Aug. 6, 2009. By that time, they were thoroughly boxed
in.
Their choices were minimal, even if
they disagreed with Klein. To do anything other than go along with
him would mean rejection of a 10-page legal opinion from Harrison,
which could be interpreted as no-confidence vote on Harrison and
possibly Klein. Board members were not interested in losing
Harrison, who has been valuable asset to the board since day one.
Overthrowing Klein was even less likely in 2009.
Harrison is currently revisiting his
2009 memo in the wake of the Institute of Medicine recommendations,
which echo some of the major Hoover proposals. The board has also
scheduled a workshop for Jan. 23 that will discuss the IOM proposals.
If Harrison produces another legal memo
that is as explicit as the 2009 document, CIRM directors will have
few choices.  The best procedure may well be for Harrison
to continue his work on the memo until after the Jan. 23 meeting.
Directors could then decide on initial steps in connection with the
IOM recommendations and ask Harrison how they can proceed legally, although the task is really more of a political challenge than a legal
one.
Directors paid $700,000 for the IOM's evaluation and advice. It is a prestigious body with virtually no critics in the scientific community. It would be odd, to say the least, for CIRM directors to now reject major recommendations from the blue-ribbon panel only because the proposals might require a statewide vote. The response is likely to be from some: Well, stem cell directors, let's have a statewide vote, and we expect you to support the IOM changes if you plan to seek additional state funding. 
Placing another stem cell measure on the ballot -- with or without related additional funding for the agency -- would bring into play a host of issues, including possible elimination of the agency. Not to mention disturbing existing stakeholder relationships and raising uncertainty in the scientific and biotech business communities. 
Directors believe the agency has made a major contribution both to California and to science. So does the IOM. The directors need to move forward on the IOM recommendations if they are to continue their research efforts beyond 2017, when cash for new grants runs out.  And putting the board in a box is not the best way to give them the room they need to maneuver. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Dh4v5HREt6Y/boxing-in-california-stem-cell-board.html

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California Editorial Unamity: Stem Cell Agency Needs Revamp

With the addition of another editorial
this week, reaction among California newspapers so far has been
unanimous that the $3 billion California stem cell agency should heed
the sweeping recommendations of the prestigious Institute of
Medicine.

The Riverside Press-Enterprise added its voice yesterday, declaring,

“Good intentions do not justify poor
practice.”

Like others, the newspaper said that
the agency “needs to revamp its governance structure to avoid
potential conflicts of interest and boost public confidence in the
agency.”
The Riverside paper focused on the conflicts of interest at the organization, which has seen about
90 percent of its funding go to institutions with ties to directors, but also supported other recommendations, including elimination of the dual executive arrangement at the research effort. 
The editorial said,

“An agency spending Californians’
money has no business being cavalier about good government practice
and ethical safeguards — no matter how promising the potential
therapies might be. The stem-cell institute is not a private fiefdom,
but a taxpayer-supported undertaking. Yet many on the stem-cell
institute’s board objected this month to the report’s
recommendations.

“The agency also said that Prop. 71’s
provisions mean that enacting many of the proposed fixes would
require either a supermajority vote of the Legislature or another
ballot measure. That prospect should warn Californians about the
dangers of voting for complex, costly, politically driven initiatives
that have little to do with fundamental state duties.

“Still, the stem-cell agency cannot
just sit on these recommendations without damaging its credibility.
The search for medical breakthroughs does not justify ignoring vital
safeguards for spending taxpayer dollars.”

For a look at other editorials, see here and here.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/70xi8-waM7k/california-editorial-unamity-stem-cell.html

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Balloting Begins on Stem Cell Person of the Year

The nominations are in. Voting has
begun, with about 1,000 ballots cast so far. But only one vote truly
counts. That belongs to Paul Knoepfler, who is running the The Stem
Cell Person of the Year
contest and will pony up $1,000 of his
hard-earned cash to honor the winner.
On Monday, Knoepfler announced 16 finalists out of 30 nominees. They range from scientists to patients
to advocates. Voting began instantly and will continue until Dec. 31
at 11:59 p.m. Votes will count for something, but Knoepfler makes it clear that they are only advisory. He makes the decision.
This is Knoepfler's first year at the
contest. The UC Davis stem cell researcher, patient advocate and
blogger wants to recognize someone who made a difference and took
some risks in doing so.
You can find the entire list of
candidates on Knoepfler's blog, but we wanted to note that they have
a father and son competing against each other – Don Reed and his
son, Roman. (Could be tense around the holiday tables in the
Reeds' households.) Also on the list is Jeanne Loring of Scripps,
whose nominator said engages the wider community with great
effectiveness. I once heard Loring say that every stem cell
researcher should have a spiel that could be delivered in five
minutes in a taxi and that would not only explain stem cell research,
but persuade the cab driver of its virtues.
All of the nominees have much to
recommend them. Knoepfler will be chewing his fingernails before this
is all over.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/_Zshc3lQops/balloting-begins-on-stem-cell-person-of.html

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Southern California Newspaper Tackles Stem Cell Agency and UC Irvine Grants

The Orange County Register today zeroed
in on the $3 billion California stem cell agency and its relationship
to the local University of California campus in the wake of sweeping
recommendations for changes at the eight-year-old agency.

The article by Melody Petersen was
headlined “Ties to stem cell board lucrative.”
Petersen began her article with story of the $20 million award to StemCells, Inc., earlier this year and
the firm's partnership with Frank LaFerla of UC Irvine, which is located in Orange County.
The award was rejected twice by
reviewers at the stem cell agency but the governing board of the
agency (CIRM) approved it on a 7-5 vote in September following
lobbying on behalf of the company by the board's former chairman,
Robert Klein, and others.
Petersen said the award was not the first time that questions have been raised about stem cell agency grants. She said that the 17-month study by the prestigious Institute of
Medicine (IOM)
and some of its findings, particularly those dealing
with conflicts of interest, echoed criticisms that have been raised for years.
She wrote,

“Repeated independent reviews of the
agency, including one by the (IOM) released this month, have found
that its board is rife with conflicts of interest. In fact, of the
$1.7 billion that the agency has awarded so far, about 90 percent has
gone to research institutions with ties to people sitting on the
board, according to an analysis by David Jensen at the California
Stem Cell Report
, which closely follows the agency's operations.

While the agency has yet to produce a
cure, Petersen said,

“What's clear already is that the
money has transformed stem cell research in California and poured
hundreds of millions of dollars into the state's universities,
including UC Irvine.”

She noted that the CIRM governing board
is dominated by members from the UC system, including two professors
at UC Irvine.
Peterson continued,

“Before Proposition 71 (the measure
that created the agency) passed, UC Irvine had less than ten stem
cell scientists, who received about $1.5 million in funding each
year. Now, after receiving $100 million in grants from the state
agency, the university has sixty scientists working to advance stem
cell research and teaching. It touts itself as one of the top stem
cell research centers in the world. In 2010, it opened an $80 million
four-story stem cell research center with the agency picking up $27
million of the cost.

“As UC Irvine has won increasing
amounts of taxpayer money, its two professors who sit on the agency's
board have risen in status on campus.

Susan Bryant
UC Irvine photo

“Professor Susan Bryant, an expert in
regenerative medicine, was dean of the School of Biological Sciences
when she was named to the agency's board in 2004. She was then
promoted to vice-chancellor of research. In July, she was named the
university's interim executive vice-chancellor and provost, its
second most powerful administrator.

“When Professor Oswald Steward, a
stem cell scientist, joined the agency's board in 2004, he was
director of UCI's Reeve-Irvine Research Center for Spinal Injury.
Since then, the scientists working in his center have received
millions of dollars in grants from the agency. In May, the university
rewarded Steward with an additional title: senior associate dean of
research for the School of Medicine.”

“The two professors are prohibited
from receiving any agency funds for their own scientific work. But so
much money has been funneled into the stem cell field in California
that it can be difficult to show their continued scientific efforts
are not somehow benefiting. For example, Bryant co-authored a
scientific article in 2009 with nine other scientists about the
genetics of salamanders, which can regenerate limbs. In the report,
the group recognized the state agency for partially funding their
work. Bryant said that the money was received by another scientist in
the group who was not employed by UC Irvine. She said the state
agency has never given a grant for research involving salamanders. 'I
have never-ever benefited from CIRM funding,' Bryant said using the
agency's acronym.

Os Steward
UC Irvine photo

“Steward said he stopped his stem
cell research when he joined the board in 2004. His board position,
he said, 'has prevented me from taking on lines of research I
otherwise would do.'

Tom Vasich, a campus spokesperson,
said Bryant and Stewart's positions on the agency's board played no
part in their promotions and success at the school.”

Petersen additionally reported that
Steward and Bryant are not allowed to vote on grants to UC Irvine.
Petersen pointed out that the
University of California has 16 members on the 29-member board. One
of those is the chairwoman of the UC Regents, Sherry Lansing.
Petersen also noted that three of the UC officials, including
Steward, hold seats on the board as patient advocates.

Petersen is a recent addition to the
Register's staff, joining it in November as an investigative
reporter. She worked as a business reporter for the New York Times and authored  "Our Daily Meds," a book about the pharmaceutical industry. She shared in the top award in newspaper financial journalism when she was at the San Jose Mercury News.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/41IPNEUfHpo/southern-california-newspaper-tackles.html

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Two More Editorials: The California Stem Cell Agency Should Heed IOM Recommendations for Reform

Two other major California newspapers
today said the $3 billion California stem cell agency needs to “clean
up its act” if it wants to be successful in continuing its efforts
at turning stem cells into cures.

The editorials appeared in the Los Angeles
Times
, the state's largest circulation newspaper at more than
700,000, and the San Jose Mercury News in California's Silicon Valley.
The Mercury News has a reported circulation of nearly 600,000,
although that figure includes other Bay Area newspaper owned by the
same chain.
Both editorials focused on the 17-month evaluation of the agency by the prestigious Institute of Medicine (IOM) as did earlier editorials in The Sacramento Bee and the San Francisco Chronicle. The IOM recommended sweeping reforms at the agency that would alter its structure and target conflicts of interest. 

“The $700,000 spent on the
study...will be wasted if the institute's oversight board fails to
heed the (IOM) committee's
criticisms,
 which echo the findings of the Little Hoover
Commission
and other groups over the years.”

The editorial continued,

“The 29-member board is made up
almost entirely of representatives of advocacy groups and research
institutions that have a direct interest in how the money is spent.”

The Times cited the California Stem
Cell Report'
s calculations that about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions linked to current and former members of its governing board. 
The Times noted an award to a Northern California firm that has stirred some criticism. The editorial said,

“The board also overrode the advice
of its scientific advisors — twice on a single application when it
considered a grant for a well-connected company, StemCells Inc. based
in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71,
which created and funded the agency in 2004, and its former head,
lobbied so intensively for the company that one board member
described it as 'arm-twisting.'"

The Times concluded,

“The agency has used more than half
of its funding and one day will almost certainly want to ask
taxpayers for more. It should remember that voters will look for
evidence of public accountability as well as respected research.”

The San Jose paper sounded a similar
note about the agency. Its editorial said,

“(I)f it wants to survive...it
should heed the Institute of Medicine's advice to eliminate conflicts
of interest on its board -- and do it before awarding the remaining
$1.2 billion of the $3 billion voters approved for stem cell
research.”

But the paper said the stem cell agency
should not be provided any more state funding.

“Long-term funding was never the
intent when Proposition 71 passed in 2004. It was supposed to
kick-start research at a time when federal funding was blocked and to
establish California as a major player in the rapidly advancing
medical field. 

“The agency could continue to bring
value to the state as an advocate and funder of research, but only if
it can attract private donors, partners and investors. For that to
happen, it will need a board that passes the ethics test, with more
independent experts and industry executives free of conflicts. 

“At the outset, stem cell advocates
took immense pride in structuring the agency to keep it relatively
free of legislative interference despite the use of public money.
Politicians kept their hands off, which was good. But the agency
created its own inappropriate influences in the way it constituted
its board. Now it needs to clean up its act.“

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hjDmQPb6wDs/two-more-editorials-california-stem.html

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Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting

Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).

Only two pieces appeared, one in the
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes
of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
One of the recommendations of the IOM
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
Fikes wrote,

"'I'm a
colon cancer survivor,' said Art Torres, vice chairman of the
oversight committee, and a patient advocate designate. 'Does having
colon cancer make me biased?'
Jeff
Sheehy
, another patient advocate designate, protested what he called
a 'defenestration' of patient advocates, whose interests often span
multiple diseases.”

Ron Leuty of the San Francisco Business
Times
skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Fikes also had a piece on ViaCyte,
which is in his area, receiving another $3 million from CIRM.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sTuRbsA7d_w/meager-coverage-of-yesterdays-bristling.html

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