Balloting Begins on Stem Cell Person of the Year

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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

Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting

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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

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

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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

LA Times: On the California Stem Cell Agency and Wasting $700,000

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The headline on the Los Angeles
Times web site this afternoon read,

"Is California's stem cell program
preparing to waste $700,000?"

The question was raised by Pulitzer
Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency. 
Hiltzik wrote, 

"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."

Harold Shapiro, chairman of the IOM
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
Hiltzik's piece summarized the IOM
proposals, which echoed many criticisms that have been aired for
years in California.  Hiltzik wrote, 

"CIRM Chairman Jonathan
Thomas glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further." 

"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."

Hiltzik concluded, 

"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.' 

"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9CY8_m5Reqo/la-times-on-california-stem-cell-agency.html

Appeals at the California Stem Cell Agency: Worthwhile or Worthless?

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Jon Shestack, a patient advocate member
of the governing board of the California stem cell agency, weighed in
today on the virtues of the grant application appeal process at the
$3 billion research enterprise.

His remarks came in a “comment”
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
Shestack said that the handling of the
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
The utility of the petitions is one of
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
The Duchenne application is not the
only “case study.” An application by Karen Aboody of the City of
Hope is often cited as another case. There are undoubtedly others.
The petition process was adopted
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
Whether appeals can be put in a tidy,
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes --  when millions of dollars and their
careers are at stake.
Opinions and decisions of CIRM
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ROhqJSUEC28/appeals-at-california-stem-cell-agency.html

ViaCyte Wins Another $3 Million from California Stem Cell Agency

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The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.

The now failed ViaCyte-Glaxo-CIRM
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
Meeting in Los Angeles, the CIRM
governing board approved the additional funds on a 13-0 vote with two abstentions.  The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.

ViaCyte
has also told Biocentury that it is pursuing even more funding after
the alliance with Glaxo broke down. CIRM President Alan Trounson said ViaCyte is likely to receive another $3 million from the Juvenile Diabetes Research Foundation. Trounson also said that other sources are being examined as well. 

Patricia Olson, executive director of
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
The ViaCyte-Glaxo-CIRM deal was cause for
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,

 “This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/qtxtQt3nhU0/viacyte-wins-another-3-million-from.html

Winners From Today's Awards by the California Stem Cell Agency

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The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.

Here is the list of researchers who won awards today.

New Faculty Physician Scientist Translational Research Awards

RN3-06530Robert BalohCedars-Sinai Medical Center $3,031,737.00
RN3-06378Reza ArdehaliUniversity of California, Los Angeles $2,930,388.00
RN3-06504Jason PomerantzUniversity of California, San Francisco $3,084,000.00
RN3-06396Mana ParastUniversity of California, San Diego $3,013,252.00
RN3-06425Tracy GrikscheitChildren's Hospital of Los Angeles $3,408,000.00
RN3-06532Tippi MacKenzieUniversity of California, San Francisco $2,661,742.00
RN3-06479Ann Capela ZoveinUniversity of California, San Francisco $3,084,000.00
RN3-06529Alan ChengStanford University $3,091,595.00
RN3-06455Ali NsairUniversity of California, Los Angeles $3,004,315.00
RN3-06460Emanual MaverakisUniversity of California, Davis $2,964,000.00
RN3-06510Michelle MonjeStanford University $2,800,536.00
RN3-06525Ophir KleinUniversity of California, San Francisco $3,084,000.00
Total   $36,157,565.00

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html

Some California Stem Cell Board Members Bristle at IOM Recommendations

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Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.

Much  of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered  under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,

 "If you had some here, I would be more comfortable." 

He continued,

"We are not all powerful. We are a minority on the (29-member) board." 

Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,

"Advocates are here to advocate."

Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.

Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.

Director Robert Price of UC Berkeley said,

 "We have gone to great lengths to manage conflicts of interest."

The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.

 The IOM report said,

 “Far too many board mem­bers
represent organizations that receive CIRM funding or benefit from
that funding. These com­peting personal and professional
interests com­promise the perceived independence of the ICOC(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”

More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.

J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.

No one from the public commented during the roughly 90 minute discussion.  Eighteen out of 29 board members were present at the beginning of today's meeting.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/m0FfxPnJUes/some-stem-cell-board-members-bristle-at.html

A Singular Scientific Story: Duchenne's Disease, a Family and the California Stem Cell Agency

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Unusual and personal conditions,
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA. 
Their research involves Duchenne
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
Carrie Miceli
UCLA photo
The researchers, Stan Nelson and Carrie
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
Miceli and Nelson have an 11-year-old
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
Adding to all this, their appeal used a
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
Stan Nelson
UCLA photo
Even prior to the IOM recommendation,
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
As for the $6 million CIRM grant, it will carry the important burden of advancing the findings that were published in the
journal Science Translational Medicine. However, the money was not used in the study reported today.
The research showed that dantrolene, the FDA-approved drug, “provides a powerful boost to
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
The news release said,

“(The researchers) hope this one-two
punch used in combination will overcome the genetic mutations that
cause DMD, restore a missing protein needed for proper muscle
function and allow those affected by the disease to lead relatively
normal lives.”

“Their youngest son, Dylan, 11, was
diagnosed with DMD in 2004. While he’s still ambulatory – many
DMD patients require the use of wheelchairs by about age 10 – Dylan
can no longer run or climb stairs and he can’t shoot a basketball
over his head like other boys his age.  Despite these
challenges, Miceli said Dylan remains a happy, funny and engaged boy,
full of life and passion.

“'We entered into this field because
of the diagnosis of our son, but we hope our research can help many
others,' she said. 'There are drugs that can help manage the symptoms
of the disease, but nothing that changes its course dramatically.
We’re trying to correct the defect that causes DMD with highly
personalized genetic medicine.'” 

UCLA said the grant from CIRM will be
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”

Asked for comment, Kevin McCormack, a
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,

"Clearly there is still a long way
to go before we know if this approach will work in people but we're
delighted that funding from the stem cell agency is helping  the
researchers move their work forward....This is what voters set out to
do when they approved Proposition 71 to create the stem cell agency."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/aAacD9507GI/a-singular-scientific-story-duchennes.html

Constitutional Questions Raised on Sweeping Changes at the California Stem Cell Agency

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The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.

More than three years ago, the same issue was raised  and used by the agency to resist unwanted changes.

Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.

Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.

In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,

“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”

The California Stem Cell Report wrote at the time, 

"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."

The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .

Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.

The IOM report, which cost the stem
cell agency $700,000, recommended a host of changes that critics for
years have said are needed. But the 17-month study also went beyond
what the critics had proposed. The IOM said that the 29-member
governing board should be stripped of power to approve individual grants.
Instead, the board would be limited to voting for or against a slate
of applications.
The IOM also proposed far-reaching
changes to remove conflict of interest problems, clean up a troubling
dual-executive arrangement and fundamentally change the nature of the
governing board. The recommendations would greatly strengthen the
role of the agency's president, significantly alter the role of
patient advocates on the governing board and engage the biotech
industry more vigorously.
CIRM's governing board and its first chairman, Robert Klein, an attorney who directed the writing of the stem cell initiative and wrote parts of it, have mightily resisted related proposals. In 2009, Klein even warned of lawsuits if legislative action were initiated for reforms (see here and here). 
In an editorial today, The Sacramento Bee said changes are long overdue at the agency. The Bee said CIRM has "been consumed by a siege mentality that has prevented any real introspection.”  In another editorial earlier this week,
the San Francisco Chronicle said that prompt and major changes are
needed at the agency.
Many of the more significant
recommendations clearly require either a rare, super, supermajority vote of
the legislature (70 percent) and the signature of the governor or
another ballot initiative, which is very unlikely. Achieving the 70
percent vote is exceedingly difficult except on the most
noncontroversial matters before the legislature. The requirement
permits only 13 members of the 40-member Senate to block any CIRM
legislation, giving minority viewpoints extraordinary power over the
content of any CIRM legislation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6UqNIAVe5JY/constitutional-questions-raised-on.html

Stem Cell Agency Chairman Says IOM Report 'Quite Complimentary'

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Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
Thomas did acknowledge that the report
“highlighted some areas and made some recommendations about where
and how we might improve our performance.” 
Thomas concluded by saying the agency
takes the report seriously and will, over the next few months,
consider how best to respond.
Nearly needless to say, other observers
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html

IOM Report: Many Major Changes at Stem Cell Agency Require Legislation

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As the Institute of Medicine began its presentation today to the governing board of the $3 billion California stem cell agency, one of its key directors, Sherry Lansing, pointed out that some of the IOM recommendations require legislative action and perhaps a vote of the people.

Her essential point was that the agency is hamstrung by the very measure that created it in 2004. She did not elaborate on her comment, but here is a look at some of matters she was talking about. (Lansing is chairwoman of the UC board of regents and former CEO of a Hollywood film studio.)

The ballot measure locked in management minutia and more, and then slapped on tight restrictions that make it nearly politically impossible to alter even such matters as who is in charge of production of the annual report. (By order of law, the chairman, in case you are wondering.)

And if the 29-member governing board -- so sized and specified to every nit and nat by the ballot measure -- wants to make the sweeping changes recommended by the IOM, agency directors face a formidable task in California's Capitol.

Many of
the most important recommendations for the California stem cell
agency require a vote of the California legislature and
signature of the governor. The IOM's choice of words – that these proposals “may” need legislation – is conservative. There is little doubt that legislative action would be needed to fully implement the recommendations below.

The vote needed is no simple majority. It is a rare, super,
super-majority (70 percent) of each house. The requirement was also written into state law by Proposition 71, the 10,000-word ballot initiative
that created the stem cell agency. The 70 percent requirement gives extraordinary power to minority viewpoints that must be dealt with to win passage of legislation. In the state Senate, for example, it would take only  13 senators to block a bill.  
With that background, here are direct quotes from the IOM report on its legislative recommendations.
Separate Operations from Oversight
The board should focus on strategic
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board should delegate day-to-day
management responsibilities to the president. Each of the three
working groups should report to management rather than to the ICOC.
Change the Composition and Structure of
the Board and Working Groups
CIRM should put systems in place to
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community. The terms of board
members should be staggered to balance fresh perspectives with
continuity.
The chair and other ICOC members should
be prohibited from serving on the working groups. During the
reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.
Revise Conflict of Interest
Definitions and Policies
CIRM should revise its definitions of
conflict of interest to recognize conflicts arising from nonfinancial
interests, such as the potential for conflict arising from an
individual’s interest in a specific disease, and should reassess
its policies for managing conflict of interest in light of this
broader definition.
Restructure the Grant Review and
Funding Process
CIRM should restructure the grant
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC should remain
responsible for oversight and articulation of an overall strategic
plan. However, grant management, funding recommendations, and grant
administration should be the responsibility of the CIRM scientific
staff, reporting to the president. This restructuring would help
mitigate concerns related to conflicts of interest and would also put
the review and funding process in the hands of those best equipped to
make those decisions.
The committee recommends several
changes pertaining to the development and approval of RFAs,
composition of the Grants Working Group, reordering of rankings by
CIRM staff, notification of applicants, and process for making final
decisions.
Enhance Industry Representation in Key
Aspects of CIRM Organization
Industry representation on the ICOC,
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group should be enhanced to leverage industry’s
expertise and resources in product development, manufacturing, and
regulatory approval in support of the ultimate goal of bringing
therapies to patients.
Consider Harmonizing Intellectual
Property Policies with Policies of Bayh-Dole Act
 As
other sources of funding for stem cell research become available and
as the field of regenerative medicine advances from the laboratory to
the clinic, the ICOC should reconsider whether its goal of developing
cures would be better served by harmonizing CIRM’s IP policies
wherever possible with the more familiar policies of the Bayh-Dole
Act.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xcudV6_VtGE/iom-report-many-major-changes-at-stem.html

More IOM-CIRM Coverage: One Story Notes Major 2007 Conflict Flaps at Stem Cell Agency

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Additional coverage emerged this morning,
including stories in the Los Angeles Times, the Nature web site and
Businessweek. on a blue-ribbon report that recommended sweeping changes
at the the $3 billion California stem cell agency

In the Times, California's largest
circulation newspaper, Eryn Brown's story was headlined,

"Stem cell
agency board criticized for conflicts of interest."

The article began,

"The board of California's stem cell
funding agency is rife with conflicts of interest and should be
restructured to improve the integrity of its grant-making process,
according to a new report from independent experts convened by the
national Institute of Medicine."“

In the San Diego U-T, reporter Bradley
Fikes' article was the only piece in all the coverage to mention two major conflict-of-interest flaps at the agency in 2007.
One involved then CIRM board member
John Reed, head of Sanford-Burnham in La Jolla, who tried to influence CIRM staff
in connection with a grant to his organization, triggering
an investigation by the state's political ethics commission. (Reed's
actions were first disclosed by the California Stem Cell Report.) The
other case involved inappropriate actions by four members of the
29-member board in an $85 million round. Ten applications were dumped
from the round because of the directors' actions. The conflict
issues were so rampant that only eight of the directors present at a
December 2007 meeting could discuss the issues.
(See here, here and here.)
On the Nature news blog, Monya Baker
had a thorough piece that said the agency “received a mixture of
praise and hard-to-enact recommendations from an august scientific
body.” She also wrote,

“It’s unclear what effect the
report will have. Many of these recommendations run counter to
requirements enshrined in the legislation that created CIRM, and the
board of CIRM has heard similar recommendations before and failed to
act on them.”

On the web site of the journal Science,
Greg Miller wrote that IOM report "praises the California Institute for
Regenerative Medicine (CIRM) as a 'bold social innovation' that
provided a creative new source of funding that has turned the state
into an international hub of stem cell research. But the IOM panel
authoring the report also concluded that the funding agency’s
organization and governance is not optimal."
Businessweek carried the AP story by
Alicia Chang mentioned yesterday. The AP story also appeared on the San
Francisco Chronicle and Sacramento Bee web sites and was also carried internationally on other web sites.  The Chronicle also had a staff story by Erin Allday.  
(An earlier version of this item did not contain the last sentence regarding the Allday story.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yk8zuHF6IKA/more-iom-cirm-coverage-one-story-notes.html

Text of Comments Reacting to IOM Report on California Stem Cell Agency

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Here is the full text or the essential
elements of comments sought by the California Stem Cell Report on the
Institute of Medicine report that recommended sweeping changes at the
California stem cell agency. Consumer Watchdog and the Center for
Genetics and Society put their comments in the form of news releases,
which contained redundant material.

From Stuart Drown, executive director
of California's Little Hoover Commission:

“CIRM initiated the Institute of
Medicine review, which is to its credit.  The Institute of
Medicine took a scrupulous and rigorous approach to its review of the
California Institute of Regenerative Medicine and in its report,
notes CIRM’s many achievements and accomplishments.

“The Institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009. The
institute graciously acknowledged the commission’s work, which
clearly is as relevant now as it was in 2009.

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

From John M. Simpson, stem cell project
director at Consumer Watchdog of Santa Monica, Ca.(full press release here):

“Consumer Watchdog Thursday welcomed
a report from the prestigious Institute of Medicine (IOM) calling for
sweeping reforms in governance at California’s stem cell agency and
an end to the board’s built-in conflicts of interest. 

“The report said that 'far too many
board members represent organizations' that receive funding or
benefit from the stem cell agency. The IOM said that the board’s
oversight function should be separated from the day-to-day management
of the California Institute for Regenerative Medicine (CIRM). 

“'The IOM's critical report echoes
what every independent evaluator has said in the past,' said John
M. Simpson, Consumer Watchdog’s Stem Cell Project director.
'As we have repeated from the beginning, CIRM suffers from built-in
conflicts of interest and needs to separate the board's oversight
function from day-to-day management.'

“'It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,' Simpson said.”

From Marcy Darnovsky, associate
executive director of the Center for Genetics and Society in
Berkeley, Ca.(full press release here):

“The Center for Genetics and Society,
a nonprofit policy research and advocacy organization, welcomed the
report on the California stem cell agency released today by the
Institute of Medicine and called for stronger protections for  the interests of Californians as
the agency continues its disbursement of public funds.

“CIRM is nearing the end of the
billions of dollars of public funding allocated to it in
2004. The agency is currently considering how to extend
its operations after the money runs out. CGS Associate Executive
Director Marcy Darnovskysaid, “Given the agency’s
shortcomings and the state’s budgetary problems, it would be wrong
to ask Californians to give it more public money. If the agency
acquires new funds from industry sources or venture firms, it must
recognize that it has ongoing obligations to the people of
California.”

“She continued, 'CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2008 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.' 

“'Today’s report from the IOM
reaffirms the significance of the conflicts of interest and
structural flaws that were built into the stem cell program from the
beginning, and that continue to threaten its credibility and
effectiveness. These are serious problems that the Center for
Genetics and Society and other public interest voices pointed out
even before the agency was approved by the 2004 ballot measure on
which backers spent some $35 million. 

“'Many aspects of these early
concerns remain directly relevant,' Darnovsky said. 'There is
still no way for elected officials to provide oversight because the
measure that created CIRM requires a 70% vote by both houses – more
than a supermajority. The agency’s governing board is still tainted
by its built-in conflicts of interest, and still includes no
representation of the public beyond disease advocates. Members of the
agency’s powerful Working Groups, including the one that reviews
grant applications, are still not required to publicly disclose their
individual financial interests.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iu4DrhoewYo/text-of-comments-reacting-to-iom-report.html

IOM Proposals for Overhaul at CIRM Win High Marks

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The Institute of Medicine's
recommendations for major changes at the California stem cell agency
today received generally high marks from independent observers and
critics.

Many of the proposals echoed
suggestions from California's Little Hoover Commission, the
state's good government agency. Asked for comment, Stuart Drown, the
commission's executive director, said,

“The institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009."

He continued,

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

The California Stem Cell Report also
asked the agency's first president, Zach Hall, for his thoughts. Here
is the full text of what Hall, who was one of the peer reviewers on
the IOM study, had to say,

“The IOM Committee and its staff have
done an impressive job.  The report recognizes the scientific
value and achievements of the CIRM and, at the same time, makes
cogent recommendations that, if taken seriously, will further improve
the quality and the public credibility of the Institute. The
committee and staff deserve the thanks of the scientific community
and all California citizens for their careful and thoughtful work.” 

John M. Simpson, stem cell project
director for Consumer Watchdog of Santa Monica, Ca., said,

“It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,” 

Marcy Darnovsky, associate executive
director of the Center for Genetics and Society of Berkeley, Ca.,
welcomed the recommendations. But she said,

“Given the agency’s shortcomings
and the state’s budgetary problems, it would be wrong to ask
Californians to give it more public money. If the agency acquires new
funds from industry sources or venture firms, it must recognize that
it has ongoing obligations to the people of California.” 

She continued,

 “CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2009 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.” 

The California Stem Cell Report also
queried most of the 10 patient advocates on the agency's governing
board for comment. Their roles could be altered in a major way by the
IOM recommendations. None of the advocates have yet responded.
(The full text or nearly
full text of all the above comments is available here.)  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yyZ0TAisMZQ/iom-proposals-for-overhaul-at-cirm-win.html

Coverage of the IOM Report: Light but a Column with a Cutting Edge

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News coverage has been light so far
today of the Institute of Medicine's recommendations for an overhaul
at the $3 billion California stem cell agency. But a Pulitzer Prize-winning columnist from the Los Angeles Times took a sharp knife to the agency's press release on the IOM report.

Michael Hiltzik, who is a regular critic of the agency, asked,

 "So how did CIRM react to the report? Even before the review panel's conference call with the press was completed, the agency issued a news release stating that the panel had 'praised' the agency 'for its ground breaking work in helping advance the science of stem cell research.'"If you wanted to know about the committee's criticisms, the first mention of those was in paragraph 9 of the news release. It quoted board Chairman Jonathan Thomas as promising to 'work on establishing a process to enable us to consider how best to proceed with reviewing the recommendations.' 

"By my count, that's seven steps it will take before actually acting on the recommendations. 

"As it happens, the panel's recommendations, which include creating a majority of independent board members without any potential conflicts of interest, track very closely to recommendations made by several previous outside reviews of CIRM, especially a 2009 study by the state's Little Hoover Commission.

"CIRM rejected almost every one, and it looks to be preparing to circle the wagons again against sensible improvements in the way it does business."

The Associated Press story by Alicia
Chang popped up in two different forms on the Washington
Post web site and in Ottowa and Spokane, among other places. Chang
was on board for the IOM news conference and had this to say about
CIRM from one of the IOM study group members.

“'They’re not broken but they’re
bent,' said Sharon Terry, president of the nonprofit Genetic Alliance
who was part of the panel. 'They need some correction.'”

Chang's story originally began,

“California has transformed into a
powerhouse player in stem cell research, but the taxpayer-funded
institute responsible for that needs an overhaul, a report released
Thursday found.”

Another version, that appeared in
Ottowa and Spokane and beyond, started this way,
“A report says California’s stem
cell agency needs more independent oversight and recommends a
restructuring to avoid the appearance of conflict of interest.”
Ron Leuty of the San Francisco
Business, who is one of perhaps two reporters who regularly cover
the stem cell agency, wrote,

“A review of California's stem cell
research funding agency proposed changes to the agency's governing
structure and commercial goals while praising its results so far. The
124-page report from the Institute
of Medicine recycles many conflict of interest and
intellectual property concerns that have dogged the San
Francisco-based” agency.

Stephanie O'Neill at KPCC radio in Los
Angeles also had a story.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XpN8S2N2-iw/coverage-of-iom-report-light-but-column.html

Collapse of Big Pharma Deal Involving California Stem Cell Agency

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A ballyhooed deal has blown apart that
would have hooked up – for the first time – Big Pharma and the $3
billion California stem cell agency.

The breakdown of the arrangement was
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
The deal was first announced Oct. 25
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.
The CIRM background memo said this week, however,

“We have recently been informed that
GSK was not able to obtain the final approval required due to
business reasons in the context of GSK's overall research and
development portfolio and investment needs and not as a result of any
scientific or technical assessment of ViaCyte's program.”

The memo gave no further details about
the Glaxo decision.
CIRM staff proposed that Viacyte, which
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
The arrangement involving Glaxo,
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.
It was the second significant
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.
CIRM staff said that advisors to the
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/p-E0ivzGfr0/collapse-of-big-pharma-deal-involving.html

Excerpts from the IOM Report on the California Stem Cell agency

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Here are excerpts from the $700,000 Institute of Medicine (IOM) report on the $3 billion California stem cell
agency -- the California Institute of Regenerative Medicine (CIRM).

Overall Comments
“Improvements to CIRM’s governance
structure, scientific program, and policies are critical to bet­ter
serving California taxpayers who elected to devote funding to promote
stem cell research in the state. The necessary changes outlined by
the IOM committee, if enacted by the state and/or the institute,
would help to instill confidence among the scientific community and
California residents in the vital work that CIRM is accomplishing.”
“It is the committee’s judgment
that overall, CIRM has done a very good job of initially establishing
and then updating the strategic plans that have set priorities for
and guided its programs, and of taking advantage of its guaranteed
flow of $300 million a year for 10 years to establish a sustainable
position in regenerative medicine for California. The challenge of
moving its research programs closer to the clinic and California’s
large biotechnology sector is certainly on CIRM’s agenda, but
substantial achievements in this arena remain to be made.
“Despite its demonstrable
achievements to date, as well as the largely positive independent
reports covering various aspects of its operations, no one would
claim that CIRM is a perfect organization or that it should adhere
slavishly to its initial form of organization, set of regulations, or
pattern of priorities. The field of regenerative medicine has
advanced rapidly since November 2004, and CIRM itself has seen the
need to alter its activities and approaches in some areas. The
committee believes the same should be true of its governance
structure, some of its administrative practices, and its use of
external perspectives on strategic scientific priorities and on the
evaluation of other key policies, such as intellectual property, to
ensure that they continue to encourage the development and deployment
of new treatments.”
“While the restrictions on amending
the administrative structure of CIRM established in Proposition 71
had the advantage of protecting the institute’s ongoing operations
from outside interference in an ethically controversial arena, they
also made it difficult to modify the organization’s structure in
response to experience and/or changing circumstances. Moreover, these
protections, whatever their benefits, appear to some to shield CIRM
from the normal accountability mechanisms in place for state
agencies.”
Conflicts of Interest
“Far too many board mem­bers
represent organizations that receive CIRM funding or benefit from
that funding. These com­peting personal and professional
interests com­promise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board. Neither the board
chair nor board members should serve on any working group. The board
itself should include representatives of the diverse constituencies
that have an interest in stem cell research, but no institution or
organiza­tion should be guaranteed a seat.”
“The problematic perception of
conflicts of interest has persisted for as long as CIRM has existed.
The IOM committee would be less concerned about individual board
members with actual or perceived conflicts of interest if the board
membership included more truly independent members. The majority of
board members should be independent, with no competing or conflicting
personal or professional interest. Broader representation from a
wider variety of stakeholders will inject new perspectives into the
panel and will help to dispel the perception of conflicts of
interest.
“CIRM also should revise its conflict
of interest definitions to include non-financial interests, such as
the potential for personal conflicts of interest to arise from one’s
own affliction with a disease or personal advocacy on behalf of that
disease. CIRM policies for managing conflicts of interest should
apply to that broader definition.”
Structure and Governance
“Currently, the ICOC (the agency's
governing board) functions both as an executor and as an
overseer—competing duties that compromise the ICOC’s critical
role of pro­viding independent oversight and strategic
direc­tion. The IOM committee recommends that CIRM’s operations
be separated from its over­sight. The board should delegate more
author­ity and responsibility for day-to-day affairs to the
president and senior management, and the ICOC’s three working
groups should report to senior management within CIRM, rather than to
the ICOC. The moves would permit the board to better focus its energy
and collective talent on strategic planning, overseeing financial
perfor­mance, ensuring legal compliance, assessing the
president’s performance, and devising a plan for preserving and
expanding its considerable assets to permit the institute to continue
its important work after the bond measures end.”
Unrealistic Goals
“While the latest round of awards
challenge teams to have filed a request to begin clinical trials or
to have completed early-stage trials in patients within four years,
the committee feels these ambi­tious goals are unrealistic. New
therapies take more time to progress to federal approval, and
early-stage clinical trials are beset by a stagger­ingly high
failure rate. Rather than judging suc­cess by simply tallying the
number of active clini­cal trials, the IOM committee suggests
that CIRM also continue its focus on underlying biological mechanisms
that drive the success or failure of a promising therapy and on
careful design of clini­cal trials. Advances in these areas will
help the entire field progress, even if a specific drug candi­date
is not approved." 
Economic Impact
“In the short term, CIRM’s
expenditures are supporting approximately 3,400 jobs and their
innovative efforts have also attracted substantial additional private
and institutional resources to this research arena in California
CIRM’s long-term impact on such critical aspects of the California
economy as state tax revenues and health care costs beyond the
shorter-term and temporary impact of its direct expenditures cannot
be reliably estimated at this point in CIRM’s history.... (T)he
estimate of the Analysis Group (2008) that the CIRM program alone
would support about 3,400 jobs as long as it was allocating about
$300 million per year in research and development grants appears
quite reasonable to the committee. To put this estimate in context,
however, total employment in California is roughly 16 million, and
NIH alone provides more than $3.5 billion per year to California
research institutions.”
Intellectual Property
“CIRM should propose regulations that
specify who will have the power and authority to assert and enforce
in the future rights retained by the state in CIRM-funded
intellectual property. CIRM should seek to clarify which state
agencies and actors will be responsible for the exercise of
discretion currently allocated to CIRM and the ICOC (the CIRM
governing board) over future determinations on issues regarding
march-in rights, access plans, and revenue-sharing rights that might
arise years after CIRM's initial funding period has passed.... (T)he
ICOC should reconsider whether its goal of developing cures would be
better served by harmonizing CIRM’s IP policies wherever possible
with the more familiar policies of the Bayh-Dole Act(federal IP law).

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Td6TGOVGYNo/excerpts-from-iom-report-on-california.html

Text of CIRM Chairman's Comments on the IOM Report

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Here is the text of comments on the IOM study of CIRM from J.T. Thomas, chairman of the agency. 

"We deeply appreciate all the hard work of the IOM committee in compiling  long and detailed report and the IOM clearly put considerable thought into compiling it. This has just been released so our Board and our staff has not had a chance to look at it yet, let alone digest its findings and recommendations, so it’s premature for us to offer any opinions. We are looking forward to the IOM presentation at the next meeting of our board, the Independent Citizens Oversight Committee (ICOC) where we’ll have a chance to talk with the IOM directly about the report. After that we’ll put together a process on how best to proceed so that we can respond in as thoughtful a manner to the recommendations as the IOM did in making them."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YkRTcgnXNqU/text-of-cirm-comments-on-iom-report.html