California Stem Cell Agency: Comparing the Critiques

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State Controller John Chiang has posted
a useful, side-by-side comparison of critiques of the $3 billion
California stem cell agency, including the Institute of Medicine(IOM)
study, along with the responses from the agency.

Chiang, the state's top fiscal officer,
has additionally posted the initial remarks Jan. 23 by CIRM Chairman
Jonathan Thomas before the stem cell agency governing board on his
plan to deal with the sweeping recommendations of the IOM.
Regardless of one's opinion of the
board's response to the IOM, Thomas adroitly handled the discussion
and vote, not a small accomplishment given the size of the board (29
members) and the legal restrictions involving public meetings. Under
state law, Thomas could not lobby significant numbers of the board in
advance of the meeting. He was restricted to engineering the approval
in a public session, which can easily take on a life of its own given
the unwieldy size of the board and the necessity for public comment.
As for the documents posted by Chiang,
he is chairman of the Citizens Financial Accountability and Oversight
Committee, the only state body specifically charged with oversight of
the agency and its board. The web site for the committee is the only
location on the Internet where Thomas' prepared remarks and the
comparison can be found.
Chiang's comparison chart includes not
only the IOM study, but last year's performance audit and the Little
Hoover Commission study in 2009. Missing, however, is the state
auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.
Here are links to the various
documents: Thomas' prepared comments, Power Point chart used by Thomas,
comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Yb7Eb9xPMvo/california-stem-cell-agency-comparing.html

Half-full, Half-empty Editorial on California Stem Cell Agency

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The California stem cell agency's
editorial road show paid off a bit again this week with a mildly
approving editorial in the Oakland Tribune.

The Feb.18 piece said that the presence
of Jonathan Thomas, a Los Angeles bond financier, as chairman of the
$3 billion agency has improved things, compared to the reign of Bob
Klein, who “built a protective shield” around the agency's
governing board and prevented action to deal with obvious
conflict-of-interest problems.
The newspaper also said that “to some
extent” the agency has brought “cutting edge” scientists to the
state and helped boost the stem cell field.
That was the half-full side of the
editorial. The half-empty side included the headline.

“California
must get its stem cell house in order”

The editorial continued:

“...{T)he agency must prove that it
understands how to properly handle the public's money. …. If
the stem cell agency can establish a record as a good steward of
public dollars to finance brilliant science, it can continue to play
a useful role in stimulating and guiding research to bring the
potential cures from stem cell research to fruition.

“If it cannot do that, it will be
just another expensive Tyrannosaurus rex.”

Thomas and company are knocking on
editorial doors around the state in hopes of building support for the
board's modest – some might say inadequate – response to
recommendations for sweeping changes at the agency.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tMt6gs55Yvs/half-full-half-empty-editorial-on.html

Monitoring the Cash and IP at the California Stem Cell Agency

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The $3 billion California stem cell
agency appears unlikely to make any changes in who gets the cash from
any commercial products that its research grants help finance despite
recommendations from the Institute of Medicine(IOM).

The subject will come up next Wednesday
during a meeting of the intellectual property subcommittee of the
governing board of the stem cell agency. Intellectual property (IP) simply
determines ownership rights and the share of any revenue from
therapies that result from research.
CIRM staff has prepared a briefing paper with recommendations for next week's meeting, which has
teleconference locations in La Jolla, Los Angeles, two in Irvine
along with the main site in San Francisco.
The document summarized two key IOM
recommendations in this fashion:

“Because CIRM is a new institution
without a track record to reassure stakeholders, and because its
finite funding timeline means as yet unknown agencies will be
enforcing these policies years down the road, 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 IP, specifically referring to march-in rights, access plans and
revenue sharing....

“Second, as other sources of funding
become more prevalent, the agency 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
BayhDole Act.”

Here are the CIRM staff
recommendations.

“CIRM staff has engaged in
preliminary discussions several years ago with other agencies
regarding future enforcement of CIRM’s regulations and agreements.
Staff proposes to restart those discussions and return to the
Subcommittee (or the Board) with a formal proposal to address future
enforcement of CIRM’s IP regulations.”

“In light of the IOM’s own
recognition that it may be premature to assess whether CIRM’s
regulations will act as a deterrence to future investment, the fact
that a number of CIRM’s regulations have been codified in statutes
and CIRM’s positive progress in its industry engagement efforts to
date, although quite early, CIRM staff proposes to continue to
monitor this area and not to pursue any changes at this time.”

The director's subcommittee is unlikely
to diverge significantly from the staff proposal, which was dated
Feb. 14 but not posted on the CIRM website until Feb. 20.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xvosTob7Zo0/monitoring-cash-and-ip-at-california.html

San Jose Newspaper Lauds CIRM Chairman Thomas

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The California stem cell agency got some good
news this week. The San Jose Mercury News ran an editorial yesterday
that was headlined,

“State stem cell agency is
taking Institutes of Medicine advice”
The 306-word editorial said CIRM
Chairman Jonathan Thomas is a refreshing change from Robert Klein,
the first chairman of the $3 billion enterprise. The brief editorial
said Thomas recognizes that the eight-year-old agency "has to mature." It said Thomas was trying to improve transparency and accountability.
The last paragraph declared,
 “If the stem cell agency can establish a record
as a good steward of public dollars to finance brilliant
science, it can continue to play a useful role in
stimulating and guiding research to bring the potential
cures from stem cell research to fruition.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZgT5-BiCODk/san-jose-newspaper-lauds-cirm-chairman.html

Time For Public Disclosure of Financial Interests of Stem Cell Agency Reviewers

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Should the scientists who evaluate
and score the applications for $3 billion in taxpayer funds be
required to publicly disclose their financial interests?

No, says the California stem cell
agency, despite concerns by the state auditor and the state's Fair
Political Practices Commission (FPPC) that date back at least six
years. The agency says that its governing board makes the decisions
on the applications – not the grant reviewers – and that the
members of the board fully disclose their economic interests.
However, last month the agency produced
a document that sheds new light on the issue. The document confirms
that the board rubber-stamps virtually all the reviewers' decisions,
going along with their actions 98 percent of the time. The board
exercised independent judgment on 28 out of 1,355 applications.
Why is this important? Here is what the state auditor said in 2007,

“(T)he FPPC believes that, under
state regulations, working group members (including grant reviewers)
may act as decision makers if they make substantive recommendations
that are, over an extended period, regularly approved without
significant amendment or modification by the committee. Thus, as
decision makers, working group members would need to be subject to
the conflict-of-interest code. This would mean that working groups
would be subject not only to the (public) financial disclosure requirements of
the Political Reform Act but also to the prohibition against a member
participating in a government decision in which that member has a
disqualifying financial interest and may be subject to the penalties
that may be imposed on individuals who violate that act.”

The auditor recommended that the stem
cell agency seek an attorney general's opinion on the matter, a
recommendation the agency agency summarily dismissed seven months later..
Then interim CIRM
President Richard Murphy, a former member of the agency's board and
former president of the Salk Institute, replied to the auditor:

"We have given careful
consideration to your recommendation and have decided it is not
appropriate to implement at this time. In almost three years of
operation and approval of four rounds of grants, the recommendations
of the CIRM working groups have never been routinely and/or regularly
adopted by the ICOC. Until the time that such a pattern is detected,
the question you suggest we raise with the attorney general is
entirely hypothetical, and is therefore not appropriate for
submission. We will, however, continue to monitor approvals for such
a pattern and will reconsider our decision if one emerges."

In the four rounds mentioned in
Murphy's response, 100 percent of reviewer decisions were
rubber-stamped by the board. In the other two rounds, the percentage
was 95 and 96 percent.
Currently, scientific grant reviewers at the stem cell agency, all of whom are from out-of-state, disclose financial and professional conflicts
of interest in private to selected CIRM officials. (See policy here.)
From time to time, grant reviewers are excused from evaluating
specific applications.
The CIRM governing board has resisted
requiring public disclosure of the interests of reviewers. The subject
has come up several times, but board members have been concerned
about losing reviewers who would not be pleased about disclosing
their financial interests.  Nonetheless, disclosure of interests among researchers is becoming routine in scientific research articles. Many universities, including
Stanford, also require public disclosure of financial interests of
their researchers. Stanford says,

“No matter what the circumstances --
if an independent observer might reasonably question whether the
individual's professional actions or decisions are determined by
considerations of personal financial gain, the relationship should be
disclosed to the public during presentations, in publications,
teaching or other public venues.”

The latest version of CIRM's conflict
of interest rules are under review by the FPPC. They do not include
any changes in public disclosure for grant reviewers. In view of the
new information that confirms that reviewers are making 98 percent of
the decisions on who gets the taxpayers' dollars, it would seem that it is long past due for public disclosure of both financial and professional
interests of reviewers. Indeed, given the nature of scientific
research and the tiny size of the stem cell community, disclosure of
professional interests may be more important than financial
disclosures.

"The public trust in what we do is
just essential, and we cannot afford to take any chances with the
integrity of the research process."

Here is the CIRM document concerning
reviewers' decisions and governing board action. The table has not
been posted on the CIRM website, but it was prepared for last month's
meeting dealing with the Institute of Medicine's recommendations for
sweeping changes at the agency, especially related to conflicts of
interest.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oma-MLcANoY/time-for-public-disclosure-of-financial.html

CIRM Board Member Prieto Critiques the IOM Stem Cell Report

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Francisco Prieto, a member of the
governing board of the $3 billion California stem cell agency, is
expressing some additional dissatisfaction with the blue-ribbon
Institute of Medicine (IOM) report for which the agency paid $700,000.

The report recommended sweeping changes
at the agency, including creation of a new majority of independent
members on the board. The IOM cited problems arising from the
built-in conflicts of interest on the board that were created by
Proposition 71, which created in the agency in 2004. Prieto's email refers to Bob Klein, who is a real estate investor and attorney. Klein
oversaw the drafting of the 10,000-word ballot measure(writing much
of it himself), ran its $35 million ballot campaign and became the
first chairman of the agency. The qualifications for chairman were written into the proposition and seemed to uniquely apply to Klein.  Prieto is a Sacramento physician who
was appointed to the board as patient advocate.
.Here is the text of Prieto's comments.
His earlier comments can be found here.

“A few more words on independence,
and the IOM.  I think Bob Klein drafted the proposition (and
remember, all of this was spelled out there – readily available to
the voters and whatever news sources they were depending on for
information) deliberately to engage patient advocates. I think  he
knew that those of us who have been active in disease advocacy have a
passion around the issue of advancing research that someone without
that background would be unlikely to have. I’m not sure exactly
what the IOM had in mind when they called for more 'independent'
members of the board, since they very unfortunately did not bother to
interview the patient advocates on the ICOC(the governing board). I
don’t know what their reason for this was, if there was one, but
they only circulated a (in my view) frankly inadequate questionnaire,
and interviewed a small handful of people. I think this was a major
flaw in their process and gave them a very limited view of our role.
It is hard for me to imagine who they might have in mind, if not
people who had been involved with some existing advocacy
organization. I think there are very few if any patient advocates who
aren’t working with some group – the only ones I might imagine
would be some independently wealthy person able to start a foundation
or research institute on their own.  With all due respect to
Bill Gates and the great work his foundation is doing with malaria
and HIV, I have written before that I think it would be absolutely
wrong and anti-democratic to create any public board or commission
that only millionaires could sit on.”

An anonymous comment was also posted
concerning the IOM report and conflicts of interest. It dealt briefly
with the issue and difficulty of managing conflicts. The comment can be found at the end of this item.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Y_gHaql_zgg/cirm-board-member-prieto-critiques-iom.html

Riverside Newspaper: 'Ethical Minefield' Still Not Cleared at Stem Cell Agency

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The California stem cell agency's
attempts to deal with the conflict of interest problems at the $3
billion research program amount to a minor fix that is not a “serious solution,” the Riverside Press-Enterprise editorialized yesterday.

The editorial came as the agency
launches a road trip campaign to convince newspaper editorial boards around
the state that the agency is worthy of continued financial support.
The agency will run out of money for new grants in less than four
years.
The Riverside editorial pointed to the blue-ribbon Institute of Medicine report in December that called for creation of a
new, independent majority on the 29-member board. None of the current
members are independent. The ballot measure that created the
agency required board members to be appointed from various
constituencies.
The newspaper said,

“That arrangement is hardly a model
of objective decision making. The agency so far has distributed about
$1.7 billion in grants, with about 90 percent of that money going to
institutions represented on the governing board. 

“Voluntary abstentions are not a
serious solution to that ethical minefield. Nor would that approach
eliminate potential conflicts, because the agency would still allow
the abstaining members to take part in the discussions and debate
about who should get the grants. 

“The Institute of Medicine instead
recommended remaking the board with truly independent members who
have no stake in grant awards. The stem-cell agency rejected that
step because it would require changing Prop. 71, either through a
super-majority in the Legislature or another ballot measure. That
excuse should be a vivid warning to Californians about the dangers of
passing complex, costly and inflexible initiatives. 

“Agencies handling billions of
taxpayers’ dollars should not avoid good government practice or
basic fiscal safeguards. The stem-cell institute offers minor fixes
when it needs substantial changes — and legislators should not
accept that cavalier approach.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VQ9QZ0E814c/riverside-newspaper-ethical-minefield.html

Stem Cell Agency Board Member Defends Independence of Many on Board

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A member of the governing board of the
California stem cell agency is taking exception to a statement on the
California Stem Cell Report that no independent members sit on that
body.

Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, referred to the
“ethical minefield” item Feb. 5, 2013. Here is the text of what
Prieto wrote,

“I have to object to this line: 'None
of the current members are independent. The ballot measure that
created the agency required board members to be appointed from
various constituencies.' 

“I think I am absolutely independent,
and I think the same applies at the very least to most if not all of
my fellow patient advocates, and probably to the biotech
representatives as well – remember that they all must come from
companies that are not involved in stem cell research.  Although
I supported the proposition, I was not involved directly in the
campaign in any way, and I did not meet Bob Klein (the first chairman of the stem cell board) or any of my fellow
board members until the day I was sworn in at our first meeting.

“The Prop. 71 language I believe
specifies that advocates must have a record of advocating for people
with the disease or diseases they represent, and not that they belong
to or work for any specific organization.  Checking my binder,
it refers to 'groups' but does not specify those – for example, it
refers to 'representative of a California regional, state or national
HIV/AIDS disease advocacy group.' I’m not sure how you would
define 'independent' but I certainly don’t think it means
'disinterested.'”

Our take: The Institute of Medicine(IOM) called for a new majority of what it described as independent
members, obviously not finding sufficient, if any, independent
members on the agency board. The IOM, the most prestigious organization of
its kind in the country, said changes were needed because of damaging
conflict of interest issues at the stem cell agency.
Prop. 71, which created the stem cell
agency in 2004, was carefully crafted to avoid the use of the word
“independent” when describing the necessary qualifications for a
board member.
 Instead the measure required that, in some cases, they
must come from very specific education institutions. (You can find the CIRM summary of all qualifications within this document.) In other cases, the speaker of the
state Assembly appoints “one representative of a California
regional, state, or national mental health disease advocacy group.”
The leader of the state Senate appoints “one representative of a
California regional, state, or national HIV/AIDS disease advocacy
group. “ Four other statewide elected officials appoint an
executive from a “California life science commercial entity.”
Prieto is correct when he says he
believes he is “absolutely independent.” But he fills a category
that represents a special constituency. What is missing from the
board is anyone who does not come from one special constituency or
another. The board was constructed in that manner to make sure it
would win the broadest measure of support from all the various major
constituencies by guaranteeing them a seat at the table where the
money is handed out.  Ironically, the full formal name of the CIRM governing board is the "Independent Citizens Oversight Committee," a piece of political legerdemain to mask the actual nature of who would sit on the board. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1YDDznoTw4E/stem-cell-agency-board-member-defends.html

Hyping the Economic Impact of the California Stem Cell Agency

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The $3 billion California stem cell agency today served up a warmed-over version of a study that would have the
public believe that the research program has had a major economic
impact on the state.

The latest study was prepared last
August by a firm that was hired under an RFP in 2010 that said it must execute "a vibrant and aggressive strategy to support the goals and initiatives of CIRM.” 
The agency paid $300,000 for the
original study but contends the report is “independent” of CIRM.
According to the CIRM press release
today, the latest version of the study by Jose Alberro of the
Berkeley Research Group claims creation of 38,000 “job years” and
$286 million in “new tax revenue” from the award of $1.5 billion. Those awards actually cost something in the neighborhood of $3 billion, given that state taxpayers must pay interest the borrowed funds that finance the agency. 
The Institute of Medicine's recent
blue-ribbon report on the stem cell agency carried remarkably different
information than the economic figures reported today. The institute's study was also financed by CIRM but at a cost of
$700,000. The report said,

“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."

Here is what the California Stem Cell Report wrote in 2011 when the first study was released:

“No doubt exists that the stem cell
spending has had a beneficial economic impact. But whether it has had
a 'significant' impact on the California economy is in the eye of the
beholder. The state's economy runs to something like $1.7 trillion a
year. If California were a nation, it would rank among one of the
larger economies in the world. The workforce totals around 18
million, making 25,000 jobs statistically less than a hiccup. Keep in
mind as well that CIRM, until 2009,  paid the interest on its
borrowing with more borrowed funds, all of which adds to the total
cost of the borrowing, which is about $3 billion on top of the $3
billion CIRM is handing out.”

By ballyhooing economic impact reports
the stem cell agency would seem to be inviting assessment of its
efforts as an industrial development enterprise, which involve
criteria significantly different than that of a research enterprise.
A few years ago, we asked the agency's then Chairman Robert Klein
whether he wanted to have CIRM assessed as industrial development
effort. His quick response was a very emphatic no. Klein nonetheless
frequently touted the figures produced under the contract with the
agency.
The latest figures are undoubtedly
likely to be cited as the agency begins a road trip around the state
to meet with newspaper editorial boards to trumpet CIRM's reponse to
the Institute of Medicine study.
See below for a full copy of the
report. We have asked CIRM for a copy of the contract with the group
that prepared it. We will carry it when we receive it.
   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/l9y8li36Cn8/hyping-economic-impact-of-california.html

Sacramento Bee: Stem Cell Agency Falling Short on IOM Recommendations

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It's exceedingly rare when the
California stem cell agency makes the front page of any newspaper.

So it is worthy of note that The
Sacramento Bee this morning carried a lengthy piece on its page one
about the agency and its response to the blue-ribbon Institute of
Medicine (IOM) report.
The headline said,

 “Analyst: Stem
cell agency reforms fall short.”

The analyst is the Institute of
Medicine, more specifically Harold Shapiro, chairman of the panel that
studied California's $3 billion research effort for 17 months at
a cost of $700,000 to the agency.
Bee reporter Cynthia Craft wrote that
Shapiro said the stem cell agency is “falling short” in its
response to the IOM recommendation.
Craft wrote,

"'There certainly is a gap between
what we recommended and what they responded with,' said Shapiro,
president emeritus at Princeton
University. ' I wish they had moved closer to our
recommendations.'"

Craft said the IOM made sweeping recommendations “emphasizing the need for new blood on a governing
board that has been plagued by the appearance of conflicts of
interest, cronyism and sluggishness in getting stem-cell products to
market.”
Craft also interviewed Jonathan
Thomas, chairman of the stem cell agency, who said some of the IOM
recommendations would take legislative action. But Thomas said that
was “out of the question.”
Craft wrote,

“The process would take years, he
said. The first opportunity to get on the ballot, for instance, would
be in the fall of 2014.”

The agency will run out of cash for new
grants in less than four years.
Craft's story was the first major news
article in years about the agency in the Bee, the only daily
newspaper in the state's capital. She reviewed a bit of the history
of the agency and concerns about conflicts of interest. She
concluded,

“Shapiro said he stands firmly behind
his committee's report. 

"'I think our recommendations sit
together and interrelate to each other well – and should have been
moved along as quickly as possible,' Shapiro said. 

"'It might have been helpful if
they indicated to us what they were willing to do and what they
weren't,' he said."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tEEJz8_Jcds/sacramento-bee-stem-cell-agency-falling.html

CIRM's Thomas: Conflicts 'Put to Bed' at Stem Cell Agency

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The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, today hailed board
action last week as putting “to bed once and for all” questions
about financial conflicts of interest by members of the agency's
governing board.

Writing on the agency's blog, Thomas
pointed to board approval of a new policy that would bar 13 of the 29
members of the governing board from voting on any grants whatsoever.
The 13 are the members who are “appointed from an institution that
is eligible to receive money.” Three other board members have ties
to institutions that receive money. Two are employees of the institutions and one is the
chair of the University of California board of regents, Sherry
Lansing. All three are appointed as patient advocate members of the
board. Currently all 16 are barred individually from voting on grants
to their institutions, but they can vote for awards to other
institutions.
Thomas proposed the plan last week to
the governing board, which approved it on a 23-0 vote with one
abstention. Thomas advanced the proposal in response to the
recommendations of a 17-month study by the Institute of Medicine(IOM).
CIRM paid $700,000 for the blue-ribbon report, hoping that it would
serve as the basis for continued financing of the agency beyond 2017,
when funds for new grants run out.
The IOM's far-reaching recommendations
included creation of a majority of independent members on the board,
which would mean some current members of the board would lose their
seats. No institutions would be guaranteed seats on the board.
Currently five members are appointed from the University of
California. The Thomas plan does not deal with those recommendations.
The IOM said “far too many” members
of the board have ties to institutions that receive funds from CIRM.
Compilations by the California Stem Cell Report show that about 90
percent of the $1.7 billion that the board has awarded has gone to
institutions linked to directors.
Thomas said that the board last week
“endorsed a framework of proposals that would dramatically change
the way the board works, and directly addresses the concerns and
recommendations of the IOM, in particular their feeling that the way
our Board works could create a perception of conflict of interest.”
Concerning the change in voting for the
13 board members, Thomas wrote,

“It was not an easy change to propose
and certainly not an easy one for our board members to approve. They
all care deeply about our mission and devote a great deal of thought,
time and energy to helping us do our work. So for 13 of them to agree
to abstain from a key aspect of their work was difficult to say the
least. And yet they did it because they felt it was important for the
overall goal of the agency.”

Thomas continued,

“So why did we take this approach?
It's simple. We want people to focus on the great work we do, on the
groundbreaking research we fund, and the impact we are having on the
field of regenerative medicine not just in California but throughout
the U.S. and around the world. As long as there are perceptions of
conflict of interest hanging over the Board, this will continue to be
difficult.”

Thomas said,

“This puts the economic conflicts
issue to bed once and for all.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GHXrGjkYixw/cirms-thomas-conflicts-put-to-bed-at.html

Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems

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The governing board of the $3 billion
California stem cell agency will remain dominated by “special
interests” even with the adoption of a plan last week responding to
the far-reaching recommendations of a blue-ribbon Institute of
Medicine (IOM) study, a columnist for the Los Angeles Times said today.

Michael Hiltzik, Pulitzer Prize winning
writer and author, wrote that IOM study showed the agency “the path
to cleansing itself of its aura of connivance and influence trading.
That the board can't even bring itself to place the proposals before
the voters or their elected representatives only shows how much money
it's willing to waste to keep living in its own little world.”
Hiltzik's column in California'slargest circulation newspaper included fresh comments from both
Harold Shapiro, who chaired 17-month IOM study, which was
commissioned by CIRM, and Jonathan Thomas, the chairman of CIRM and
who drew up the response.
Hiltzik wrote that the study “concluded
that the CIRM board members were saddled with 'almost unavoidable
conflicts of interest, whether actual or perceived.'” He continued,

“That's because by law, 23 of the 29
members must be representatives of California institutions eligible
for CIRM grants or of disease advocacy groups with their own interest
in steering money toward their particular concerns. 

“As a remedy, the panel proposed
eliminating some board slots reserved for grant-receiving
institutions by Proposition
71, the 2004 initiative that created the agency. The idea
was to fill those slots with truly independent members free of any
stake in CIRM funding, even indirectly.”

 Hiltzik wrote,

 "Thomas told me his proposal dealt
with even perceived conflicts of interest on the board in such
"definitive fashion" that it won't be necessary to bother
the Legislature, much less the voters, with such big changes as
remaking the board with a majority of independent members. He pointed
out, not without some pride, that one board member called his
proposed changes 'draconian.'"

Hiltzik had some praise for Thomas.

“Let's stipulate that Thomas has, in
CIRM terms, moved a mountain by jostling the board even this far.
Since its inception, the board has set records for arrogance. That's
a direct legacy from Proposition 71, which exempted the stem cell
program, uniquely among California government bodies, from any
practical oversight by the Legislature or elected officials.”

The Times columnist continued,

“Shapiro told me from his Princeton
office that Thomas' proposals were 'a significant step in the right
direction, which at least indicates that they haven't ignored the
report.' But he doesn't share Thomas' view that voluntary recusals
solve the conflict of interest problem. That can be done, Shapiro
said, only by replacing stake-holding board members with
independents.

"'The more you can reduce the
inherent conflicts, the better off everyone is going to be,' he said.
The board will 'have to go further over time, in my view.'"

Hiltzik wrote,

“The Shapiro panel said it didn't
find any instances of inappropriate behavior by board members or
specific conflicts, but there are two reasons for that: It didn't
search for any, and Proposition 71 defined certain conflicts out of
existence. The measure states that it's no conflict for a board
member to also be an officer of an academic institution or private
corporation that might be applying for grants.

“One of the CIRM board's enduring
self-delusions is that its conflicts of interest are purely a matter
of 'perception.' But there have been documented instances
of favoritism shown to well-connected grant or loan applicants, and
at least one overt attempt by a board member to overturn a rejection
of his institution's project. So much of the board's discussion takes
place behind closed doors or informally that the opportunities for
mutual back scratching are incalculable.

“Thomas' 'draconian' proposals won't
change this state of affairs. Special interests will still dominate
the board. Will barring 13 members from voting on grants while giving
them full rein to participate in discussions really eradicate even
the perception of conflicts? You'd have to be terminally naive to
think so.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/I_jSJSpM3nU/los-angeles-times-columnist-stem-cell.html

Patient Advocate Reed Defends Patient Advocates on Stem Cell Board

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Patient advocate Don Reed, declaring that the Institute of Medicine's (IOM) 17-month study of the $3 billion California stem cell agency is "grossly misguided," this weekend nonetheless said the agency took "the high road" in its response to the study's recommendation.

Reed, of Fremont, Ca., was particularly incensed about the IOM's recommendations concerning patient advocates on the board. The IOM said that none of the board members, including patient advocates, should vote on grant applications secretly in grant review groups. The IOM said their votes should be recorded in public at full board meetings. Other patient advocates would still have seats on the grant review group, under the IOM recommendations. But they would not also be members of the governing board.

The IOM also said that CIRM should also revise its conflict of interest standards to regulate personal conflicts of interest, such as those involving particular diseases and patient advocates. Some members of the CIRM governing board bristled at the recommendation, and the board did not act on it last week.

Last Wednesday, the CIRM board acted to permit board members who are patient advocates to continue to participate in the closed door grant review sessions, but not vote on the grants at that stage. Previously patient advocates had two cuts at applications, one in the grant review group and one at the public board meeting.

Writing on the Daily Kos blog, Reed also said that no real conflicts of interest currently exist on the board, although 90 percent of the $1.7 billion that has awarded has gone to institutions tied to board members.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SmmFtyc1zXo/patient-advocate-reed-defends-patient.html

Loring on Patient Advocates and Their Role at the California Stem Cell Agency

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The following statement by stem cell researcher Jeanne
Loring was read at the January 23, 2013, meeting of the governing board of the California stem cell agency. Loring is director
of the Center for Regenerative Medicine at the Scripps Research
Institute in La Jolla, CA.

“I am sorry that I
cannot attend this important meeting of the ICOC. I'm in Toronto
reviewing stem cell grants for Japan and Canada. I've asked (patient advocate) Don Reed
to read my statement.
“I am a California
stem cell scientist whose research is funded by the NIH, private
foundations, and CIRM. I am the director of one of CIRM's shared
laboratories, which has provided formal training in research and
ethics to hundreds of young stem cell scientists. My CIRM funding
supports the stem cell genomics research that is the main focus of
the lab. We have also been funded by CIRM to investigate stem cell
therapies for Alzheimer disease and multiple sclerosis. I have
leveraged CIRM grant support to obtain funding for studies of autism
through the NIH, and for Parkinson's disease from a private
foundation.
“The IOM report
recommended a number of changes in CIRM's policies. One of these
recommendations is of especially great concern to me: the suggestion
that patient advocates should have much less influence in CIRM's
decisions about what research should be funded.
“Patient advocates
are extremely valuable to us researchers. Most of us stem cell
researchers had never met a patient advocate- and perhaps not even a
patient- before CIRM was founded. In my 20 years of being funded by
the NIH, the funding agency never once suggested that I should talk
to people who have the disease, or have relatives with a disease that
I was receiving funding to study.
“With my first CIRM
grant, I started meeting patient advocates, and now I can't imagine
pursuing a disease-related research project without them. I've
learned a great deal from the advocates on the ICOC, and I greatly
enjoy talking with them. They are wonderful sources of knowledge:
Jeff Sheehy taught me about HIV/AIDS and patient activism, I learned
about Parkinson's disease from Joan Samuelson, autism from John
Shestack, and David Serrano-Sewell, Diane Winoker have educated me
about MS and ALS.
“Professional
research scientists are competitive by nature- a conversation between
scientists is often constrained by our secrecy- we need to publish,
or perish. But advocates have no such constraints, which makes ICOC
meetings more enjoyable and informative than many scientific
meetings.
“Patient advocacy has
made me a better scientist. Advocacy makes CIRM-funded research
breathtakingly relevant and uniquely powerful to change the course of
medicine.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/l-jQiD3JTec/loring-on-patient-advocates-and-their.html

Stem Cell Agency Adds Fresh Details to IOM Response

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The California stem cell agency today
issued a press release touting “dramatic changes” at the agency in response to critical recommendations by the Institute of Medicine.

The press release contained a few more
details about the changes than were released in the Power Point
presentation yesterday. Here is the text of those details.
  • “The 13 Board members appointed from
    institutions eligible for funding from the stem cell agency, such as
    those in the University of California system, would no longer vote on
    any grants brought before the Board but would instead abstain
  • “All members of the Board would
    be able to participate in discussions on applications but only
    patient advocates and independent members of the Board would be able
    to vote on funding issues (members would continue to refrain from
    any discussion of specific applications from their institutions)
  • “Patient Advocates would
    continue to be members of the Grants Working Groups but would not
    vote on individual applications
  • “Programmatic review, aimed at
    balancing the agency’s portfolio, would take place at public Board
    meetings where members have a chance to make changes to
    recommendations from the Grants Working Group
  • “Industry involvement would
    increase, where appropriate, on the Grants Working Group, and also
    feature in a newly constituted Scientific Advisory Board; the
    structure and membership of this group is still under discussion
  • “Appeals on applications not
    recommended for funding will be handled by science staff who will
    evaluate them, determine if they merit further review by the Grants
    Working Group, and ultimately make recommendations to the Board.
    Staff will also be allowed to advocate for additional grants not
    recommended for funding by the Grants Working Group that they
    believe should be considered in programmatic review
  • “The Chair and President would
    share a division of responsibilities with the President supervising
    all scientific operations and internal operational responsibilities.
    In addition the Chief Financial Officer would report to the
    President. The Chair would handle the ‘external affairs’ aspect
    of the agency, things such as financial sustainability to raise
    additional funds, state legislative relations, bond financing,
    public communications etc.
  • “IOM recommendation on the
    creation of a Scientific Advisory Board to provide counsel on such
    issues as funding priorities and portfolio strategy will be
    implemented by staff
  • “IOM recommendations on
    Intellectual Property will be referred to the agency’s IP
    subcommittee which will review and report back to the full board
    with options and recommendations
  • “IOM recommendations on
    Sustainability: Chair, working with the President, will develop a
    plan to address this and present to the Board when ready

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MHSytXHG-zU/stem-cell-agency-adds-fresh-details-to.html

IOM's Shapiro Wants to See More Changes from California Stem Cell Agency

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Additional mainstream media news
coverage surfaced last Friday involving the California stem cell
agency's response to the blue-ribbon report from the Institute of
Medicine(IOM), whose concerns about the agency ranged from conflicts of interest to grant
appeals by rejected researchers.

One of the more interesting pieces was
done by Stephanie O'Neill of Los Angeles radio station KPCC. To her
credit, she contacted the chairman of the IOM panel, Harold Shapiro,
for his fresh take on what the stem cell agency's board did on
Wednesday.
His comments were somewhat different
than those read Wednesday at the CIRM board meeting. On Friday, Shapiro was quoted as
saying the board action was “an important first step forward,”
but he added a caveat. O'Neill wrote,

“'I’m encouraged by this,' Shapiro
told KPCC. 'Presumably in the future they’ll take other steps. But
these are steps they could take without any legislative approval and
…I think it does respond in a pretty significant way to the spirit
of the report.'
“But Shapiro expressed concern that
the agency is making only 'small moves' to address a recommendation
that CIRM separate operations from oversight. Currently, the ICOC
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,' according to the December IOM
report.
“'But  I do understand… that
would be a move that they would have to take over time so we’ll
have to wait and see,' Shapiro said.
“Thomas agreed and said that while
CIRMs recommendations more clearly define the roles of chairman and
president, more refinements will be likely over time.”

From the Los Angeles Times, came a
piece from Eryn Brown. Her article was brief and she referred her
readers to the California Stem Cell Report for details. Her first
paragraph said,

“Changes may be on the way at
California’s stem cell funding agency.”

In coverage outside the mainstream media,
the Burrill Report carried an article by Daniel Levine. The Burrill
Report is produced by Burrill & Co., a San Francisco life
sciences financial firm. Levine's straight-forward account was
largely based on the CIRM press release and the IOM report.
Two bloggers surfaced with some
coverage. UC Davis stem cell researcher Paul Knoepfler, who is a CIRM
grantee, called the Thomas plan a “bold one-year experiment” and
“biggest development for CIRM in many years.” Knoepfler said,

“I’m still not sure I’m a fan of
all of the proposed changes, but I would say the plan is bold and
creative.”

On livingbiology.com, an unidentified
CIRM grantee carried a few brief items live from the meeting.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A2ayEbm2Se0/ioms-shapiro-wants-to-see-more-changes.html

Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations

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Here is the roll call vote yesterday on the plan to deal with the findings of the Institute of Medicine
concerning the California stem cell agency. The vote was 23-0 with
one abstention. The board has 29 seats. Not all board members were in attendance,
and it is not entirely clear whether all the board members in attendance
voted. Among other things, the plan calls for members with links to
institutions that could benefit from CIRM awards to voluntarily refrain from
voting on any applications for funding – not just those to their
institutions. The roll call was provided by a spokesman for the
agency.

Yes votes
David Brenner, dean of the UC San
Diego medical school.
Anne Marie Duliege , vice president of
Affymax
Michael Freidman, CEO City of Hope
Michael Goldberg, executive chairman of Nodality, Inc., and DNAnexus, appointed as executive officer of a commercial life science entity
Sam Hawgood, dean of the UC San
Francisco medical school
Steve Juelsgaard, former executive
vice president of Genentech, appointed as executive officer of a
commercial life science entity
Sherry Lansing, chairwoman of the UC
board of regents, appointed as patient advocate
Jacob Levin, assistant vice
chancellor, research, UC Irvine, and alternate for Sue Bryant,
interim provost at UC Irvine
Bert Lubin, CEO of Childrens Hospital,
Oakland
Robert Price, associate vice
chancellor for research, political science professor, alternate for
the UC Berkeley chancellor
Francisco Prieto, Sacramento physician
and patient advocate member of the board
Robert Quint, San Jose physician and
patient advocate member
Duane Roth, San Diego businessman,
appointed as executive officer of a commercial life science entity
Joan Samuelson, patient advocate member
Jeff Sheehy, patient advocate member
Jon Shestack, patient advocate member
Os Steward, patient advocate member and
head of the Reeve-Irvine Research Center at UC Irvine
Jonathan Thomas, chairman of the board
and Los Angeles bond financier
Art Torres, patient advocate member
Kristiina Vuori, interim CEO of
Sanford Burnham Research Institute
Diane Winokur, patient advocate member

Claire Pomeroy, dean of the UC Davis medical school
Shlomo Melmed, senior vice president for academic affairs, Cedars Sinai
Abstaining
Michael Marletta, CEO of Scripps
Research

(Editor's note: Based on information provided by CIRM, an earlier version of this item incorrectly reported that the vote was 21-0. It also contained errors on three names. All have been corrected. Thanks for the heads up on the misspellings from a board member who will remain unnamed.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DYyBzk0Er5g/roll-call-vote-on-thomas-plan-dealing.html