Category Archives: Stem Cells
Riverside Newspaper: 'Ethical Minefield' Still Not Cleared at Stem Cell Agency
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.
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.
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:Stem Cell Agency Board Member Defends Independence of Many on Board
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,
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.
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.
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.”
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.
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:Sacramento Bee: Stem Cell Agency Falling Short on IOM Recommendations
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.
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.
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.
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.”
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.”
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.
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,
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:Hyping the Economic Impact of the California Stem Cell Agency
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.”
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.
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.
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,
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 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.
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.
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:CIRM's Thomas: Conflicts 'Put to Bed' at Stem Cell Agency
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.
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 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.
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.
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.”
“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,
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:Stem Cell Agency Plan Falls Far Short of Solving IOM Concerns
Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems
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.”
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.
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 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:Patient Advocate Reed Defends Patient Advocates on Stem Cell Board
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:Loring on Patient Advocates and Their Role at the California Stem Cell Agency
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.
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.
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.
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.
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.
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.
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.”
made me a better scientist. Advocacy makes CIRM-funded research
breathtakingly relevant and uniquely powerful to change the course of
medicine.”
Source:Stem Cell Agency Adds Fresh Details to IOM Response
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.
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:IOM's Shapiro Wants to See More Changes from California Stem Cell Agency
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.
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,
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,
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.
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,
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.
CIRM grantee carried a few brief items live from the meeting.
Source:Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations
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.
Diego medical school.
Anne Marie Duliege , vice president of
Affymax
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
Francisco medical school
Steve Juelsgaard, former executive
vice president of Genentech, appointed as executive officer of a
commercial life science entity
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
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
chancellor, research, UC Irvine, and alternate for Sue Bryant,
interim provost at UC Irvine
Bert Lubin, CEO of Childrens Hospital,
Oakland
Oakland
Robert Price, associate vice
chancellor for research, political science professor, alternate for
the UC Berkeley chancellor
chancellor for research, political science professor, alternate for
the UC Berkeley chancellor
Francisco Prieto, Sacramento physician
and patient advocate member of the board
and patient advocate member of the board
Robert Quint, San Jose physician and
patient advocate member
patient advocate member
Duane Roth, San Diego businessman,
appointed as executive officer of a commercial life science entity
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
head of the Reeve-Irvine Research Center at UC Irvine
Jonathan Thomas, chairman of the board
and Los Angeles bond financier
and Los Angeles bond financier
Art Torres, patient advocate member
Kristiina Vuori, interim CEO of
Sanford Burnham Research Institute
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
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
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:Nature on the IOM and the California Stem Cell Agency
The journal Nature today said on its
web site that the California stem cell agency plans to make a “few
changes” in response to a critical report from the Institute of
Medicine(IOM).
A short piece by Monya Baker on the agency's response yesterday summarized
some of the IOM recommendations and the CIRM response. Baker wrote,
some of the IOM recommendations and the CIRM response. Baker wrote,
She said,
"Other IOM recommendations were only
indirectly addressed by (CIRM Chairman J.T.) Thomas’ plan. The IOM report had stated
that the board should restrict itself to an 'oversight' role
rather than an 'operational' role. Thomas’s recommendations
instead described ways to avoid overlapping duties. His own role as
chair is to handle 'external affairs' whereas CIRM’s president
will be to handle scientific and internal affairs."
Baker also carried the favorable
comments from John M. Simpson of Consumer Watchdog.
comments from John M. Simpson of Consumer Watchdog.
Source:California Stem Cell Agency to Pitch Newspaper Editorial Boards
The California stem cell agency is
planning an editorial road show with major California newspapers to
explain its new plan to deal with the recommendations of the
Institute of Medicine(IOM) for major changes at the agency.
In what might be called the kickoff to the campaign, the agency this afternoon issued a press release hailing the plan as making “dramatic changes.”
The agency could have a tough audience.
The newspapers editorializing on the subject were unanimously in
favor of the IOM recommendations. One said the agency needs to clean
up its act. They warned of a loss of public trust along with losing the
possibility of continued financial support. (For a sample, see here
and here.)
CIRM Chairman J.T. Thomas said during
today's meeting that a public relations foray was in the works
following board action on his proposals yesterday. He said,
today's meeting that a public relations foray was in the works
following board action on his proposals yesterday. He said,
“The opportunity is ripe.”
His comments came after CIRM Director
Jeff Sheehy, a UCSF communications manager, urged engaging the
editorial boards.
Jeff Sheehy, a UCSF communications manager, urged engaging the
editorial boards.
Thomas' plan meets only a portion of
the IOM recommendations and sidestepped a call for
creating a new majority on the board of independent members. The IOM
said “far too many” board members – at least 13 – are tied to
institutions that receive money from CIRM. Thomas' plan would have
the 13 voluntarily restrain from voting on any grants for any
institution.
the IOM recommendations and sidestepped a call for
creating a new majority on the board of independent members. The IOM
said “far too many” board members – at least 13 – are tied to
institutions that receive money from CIRM. Thomas' plan would have
the 13 voluntarily restrain from voting on any grants for any
institution.
A compilation by the California Stem
Cell Report shows that roughly 90 percent of the $1.7 billion awarded
by directors has gone to institutions with links to the directors.
Cell Report shows that roughly 90 percent of the $1.7 billion awarded
by directors has gone to institutions with links to the directors.
Source:Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More
Directors of the $3 billion California
stem cell agency today approved a far-reaching plan aimed at resolving long-standing
conflict of interest issues involving the agency's governing board
and also at helping to maintain credibility with the public.
 |
| Jonathan Thomas CIRM photo |
The framework of the proposal by CIRM
Chairman J.T. Thomas moved forward on a 23-0 vote with one
abstention. He laid out the plan in response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. Details will be worked out and come back to the board in March.
Chairman J.T. Thomas moved forward on a 23-0 vote with one
abstention. He laid out the plan in response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. Details will be worked out and come back to the board in March.
Acknowledging that many board members
were not pleased with the IOM criticism of the agency, Thomas said,
were not pleased with the IOM criticism of the agency, Thomas said,
“This is one of those times that we must move forward and compromise.”
He
said issues such conflicts of interest have “stolen focus” from
the good scientific work that the agency has funded.
said issues such conflicts of interest have “stolen focus” from
the good scientific work that the agency has funded.
Thomas was reacting to the $700,000 IOM
study commissioned by CIRM governing board. The IOM recommendations
called for removing conflict
of interest problems, cleaning up a troubling dual-executive arrangement
and fundamentally changing the nature of the governing board. The IOM proposals would strip the board of its ability to approve individual grants,
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.
study commissioned by CIRM governing board. The IOM recommendations
called for removing conflict
of interest problems, cleaning up a troubling dual-executive arrangement
and fundamentally changing the nature of the governing board. The IOM proposals would strip the board of its ability to approve individual grants,
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.
Thomas' plan, which would be put in
place for up to a one-year trial period, would not do all that the
IOM wanted, but would move strongly in that direction.
place for up to a one-year trial period, would not do all that the
IOM wanted, but would move strongly in that direction.
State Controller John Chiang, chairman
of the only state entity with financial oversight over CIRM, endorsed
most of the proposal, said deputy controller Ruth Holton-Hodson. She
told CIRM directors that Thomas' plan was thoughtful and positive,
although Chiang did not support continued involvement of the chairman
in day-to-day operations.
of the only state entity with financial oversight over CIRM, endorsed
most of the proposal, said deputy controller Ruth Holton-Hodson. She
told CIRM directors that Thomas' plan was thoughtful and positive,
although Chiang did not support continued involvement of the chairman
in day-to-day operations.
The Thomas plan, which would not require legislative approval, would:
- Have 13 members of the 29-member board
refrain from voting on specific grant applications. The 13 would be from institutions that could benefit from CIRM grants. They would be
allowed to participate in discussions. Thomas said this would deal
with financial conflict of interest questions. - Increase industry participation of
industry in grant application review and step up business involvement
internally at CIRM, including development of RFAs. - Redirect all scientific appeals to
staff to evaluate for possible re-review before they go to the full
board. - Move “programmatic” review of
grants to public sessions of the full board instead of being held
behind closed doors during grant review sessions. Patient advocate
directors now sitting on the grant review group would no longer be
allowed to vote during the closed-door review sessions, but they
could participate in the discussion.
It appears, however, that the Thomas
plan would do little to deal with the dual-executive problems identified
by the IOM.
Consumer Watchdog's John M. Simpson, a
long observer of the stem cell agency, welcomed the response by
CIRM. Writing on his blog, Simpson said,
long observer of the stem cell agency, welcomed the response by
CIRM. Writing on his blog, Simpson said,
"It looks like
the message is finally getting through to California's stem cell
agency board....
Part of what is driving the new
approach is the realization that CIRM will need to find a new source
of funding -- possibly going back to the voters -- if it is to
continue. As Thomas told the board today, 'If we don't
have credibility, we won't have a chance of sustaining the agency.'"
During the lengthy debate this
afternoon, one director after another said they did not agree with
all that the IOM had to say, but said maintaining credibility and
trust was the key to the sustainability of the organization.
afternoon, one director after another said they did not agree with
all that the IOM had to say, but said maintaining credibility and
trust was the key to the sustainability of the organization.
CIRM will run out of money for new
grants in less than four years. Thomas said he is working on a plan
to continue the agency's effort into the future. Details of that will
be disclosed later, he said.
grants in less than four years. Thomas said he is working on a plan
to continue the agency's effort into the future. Details of that will
be disclosed later, he said.
(Editor's note: An earlier version of this item, based on incorrect information from CIRM, said the vote was 21-0. The correct figure is 23-0.)
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Phybdqb0SV0/iom-california-stem-cell-directors.html
Meager, Meager Coverage of Yesterday's IOM-Stem Cell Meeting
The $3 billion California stem cell
agency seemed all but invisible this morning in terms of mainstream
media coverage.
Only one major outlet reported on
the watershed events yesterday at the CIRM governing board meeting at
the Claremont Hotel in Oakland – at least from what our Internet
searches show.
the watershed events yesterday at the CIRM governing board meeting at
the Claremont Hotel in Oakland – at least from what our Internet
searches show.
The piece was written by Bradley Fikes
in the San Diego U-T, the dominant daily newspaper in that area,
which is a major biotech center. The major media in the San Francisco
Bay area, home to the stem cell agency and also a biotech center, were absent from the coverage.
in the San Diego U-T, the dominant daily newspaper in that area,
which is a major biotech center. The major media in the San Francisco
Bay area, home to the stem cell agency and also a biotech center, were absent from the coverage.
Fikes wrote a straight forward account
of the meeting, saying that the governing board voted “ to
accept in concept proposed
changes to reduce conflicts of interest on the agency's
governing committee.”
of the meeting, saying that the governing board voted “ to
accept in concept proposed
changes to reduce conflicts of interest on the agency's
governing committee.”
Fikes wrote the story based on the audiocast of the meeting. He probably would not have written his daily piece without the availability of the audiocast.
Some of those connected with the stem
cell agency often wonder about the lack of mainstream coverage of its doings,
particularly the lack of favorable coverage.
cell agency often wonder about the lack of mainstream coverage of its doings,
particularly the lack of favorable coverage.
Much of it has to do with the shriveled
state of the media business, which is understaffed and overworked
compared to 15 years ago. Specialized science reporters are all but
an extinct species. Also, the mainstream media has traditionally
ignored the affairs of most state agencies.
state of the media business, which is understaffed and overworked
compared to 15 years ago. Specialized science reporters are all but
an extinct species. Also, the mainstream media has traditionally
ignored the affairs of most state agencies.
Speaking as a former editor at a major
Northern California newspaper, I would not have sent a reporter to
cover this week's two-day CIRM board meetings. It would have consumed
too much valuable time with little likelihood of a major story,
especially when weighed against other story possibilities. There was
no guarantee that the board would have even acted. The events and
their significance could be better handled in a roundup story later
with more perspective, perhaps keying on the board's meeting in
March, where details of yesterday's action will be fleshed out. The
fact is that many, very important events occur within state
government every day that never receive media attention. Some don't
even see the light of day until a catastrophe occurs.
Northern California newspaper, I would not have sent a reporter to
cover this week's two-day CIRM board meetings. It would have consumed
too much valuable time with little likelihood of a major story,
especially when weighed against other story possibilities. There was
no guarantee that the board would have even acted. The events and
their significance could be better handled in a roundup story later
with more perspective, perhaps keying on the board's meeting in
March, where details of yesterday's action will be fleshed out. The
fact is that many, very important events occur within state
government every day that never receive media attention. Some don't
even see the light of day until a catastrophe occurs.
All of this may be deplorable in the
eyes in stem cell agency backers and others, but it is the reality of
today's news business.
eyes in stem cell agency backers and others, but it is the reality of
today's news business.
Source:UC Davis Stem Cell Researcher: 'Ivory Tower' IOM Recommendations Harmful to California Stem Cell Agency
The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.
None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.
“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient, used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”
actually make CIRM less effective and less responsive to patients and
California citizens.”
He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”
He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM 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,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board."
Knoepfler said,
“(The) IOM itself admits there is no
evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”
Knoepfler also wrote,
“Interestingly, highlighting the
extremely sensitive nature of this issue, while I’ve been talking
with many bigwigs about this, at this point no one is wiling to go on
the record with an opinion about it except one courageous soul, Don
Reed (see
his piece here).”
There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.
California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.
Source:Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations
The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, yesterday outlined how
he intends to proceed next week when the agency's governing board
considers the far-reaching recommendations of a blue-ribbon Institute
of Medicine panel.
Writing on the agency's blog, Thomas
said,
said,
“While some of the IOM’s
recommendations are administrative in nature and can be implemented,
others are much more complex and would require changes in (governing)
board policy or legislative changes.”
 |
| Jonathan Thomas, chairman of CIRM governing board at far right. Art Torres (center), co-vice chair and former state Democratic party chairman, who would play key role in dealing with lawmakers. Robert Klein is at the left in this 2011 meeting, Klein's last as chairman of the agency and the one in which Thomas was elected chairman. |
He continued,
“My goal is to strive to reach
consensus on a course of action on the 23rd. However, if the board
isn’t able to choose a course of action at this time we will
continue the conversation and bring it up at future board meetings
until we reach agreement.”
It is worth noting that Thomas did not
mention the possibility of having to ask the people of California to
amend the state constitution, which would require a statewide election. Opponents to change at the agency have
used that possibility to discourage action. (See here and here.) An
election would be costly, politically difficult and could open the
door to additional unwelcome changes at the eight-year-old research
enterprise.
mention the possibility of having to ask the people of California to
amend the state constitution, which would require a statewide election. Opponents to change at the agency have
used that possibility to discourage action. (See here and here.) An
election would be costly, politically difficult and could open the
door to additional unwelcome changes at the eight-year-old research
enterprise.
Thomas' desire for a consensus among
the 29 board members – instead of a simple majority – could be a
stumbling block as the board becomes snarled internally, perhaps for
months or more. The board normally meets only about once a month and
has a full slate of regular business on those occasions. The agency
will run out of money for new grants in less than four years, and
action on the IOM recommendations seems a necessary prelude to
winning continued financial support.
the 29 board members – instead of a simple majority – could be a
stumbling block as the board becomes snarled internally, perhaps for
months or more. The board normally meets only about once a month and
has a full slate of regular business on those occasions. The agency
will run out of money for new grants in less than four years, and
action on the IOM recommendations seems a necessary prelude to
winning continued financial support.
While four years would appear to an ample
period of time, making the sort of changes the IOM recommends would
require legislative action, which probably would take a minimum of a
year. Timing is important as well. The current leaders in the state
Senate and Assembly will be termed out in 2014. Starting all over
with novice leadership, changes in key committee chairmanships and so
forth would make the task even more difficult. Then there is the need
to address strategies for continued financial support. Should the
agency seek a new statewide bond measure (the current funding
mechanism)? If so campaign committees need to be formed, electoral
strategies planned and tested and tens of millions of dollars raised
for campaign expenses. If private funds instead are to be raised to
the tune of hundreds of millions of dollars(the agency spends about
$300 million a year), such an effort would also require considerable time.
To keep the funding pipeline full, all of this should be completed
well before the money runs out in 2017.
period of time, making the sort of changes the IOM recommends would
require legislative action, which probably would take a minimum of a
year. Timing is important as well. The current leaders in the state
Senate and Assembly will be termed out in 2014. Starting all over
with novice leadership, changes in key committee chairmanships and so
forth would make the task even more difficult. Then there is the need
to address strategies for continued financial support. Should the
agency seek a new statewide bond measure (the current funding
mechanism)? If so campaign committees need to be formed, electoral
strategies planned and tested and tens of millions of dollars raised
for campaign expenses. If private funds instead are to be raised to
the tune of hundreds of millions of dollars(the agency spends about
$300 million a year), such an effort would also require considerable time.
To keep the funding pipeline full, all of this should be completed
well before the money runs out in 2017.
Dilly-dallying this year in drawn-out, fruitless debate over
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.
In his blog item, Thomas sounded this
final note.
final note.
“It’s likely the debate will be
passionate – everyone involved in this work cares deeply about it –
and there will undoubtedly be disagreements, but ultimately we all
share the same goal, a desire to make sure that whatever we decide
helps make the stem cell agency even stronger and more effective, and
is in the best interests of the people of California.”
Source:StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency
Remember StemCells, Inc., and the $40
million it was awarded by the California stem cell agency.
million it was awarded by the California stem cell agency.
The Newark, Ca., firm, founded by
eminent Stanford researcher Irv Weissman, received an award of $20
million last July and then again in September. Nearly five months
later, however, the stem cell agency has yet to cut a check for the
company, a spokesman for the agency told the California Stem Cell
Report in response to a query.
eminent Stanford researcher Irv Weissman, received an award of $20
million last July and then again in September. Nearly five months
later, however, the stem cell agency has yet to cut a check for the
company, a spokesman for the agency told the California Stem Cell
Report in response to a query.
The hang-up is the $40 million in
matching funds that the company promised the agency. The stem cell
agency has yet to be satisfied that StemCells, Inc., can actually
produce the match, although the spokesman did not offer details.
matching funds that the company promised the agency. The stem cell
agency has yet to be satisfied that StemCells, Inc., can actually
produce the match, although the spokesman did not offer details.
The StemCells, Inc., awards were
unusual in a number of ways. It was the first time that former CIRM
Chairman Robert Klein lobbied the CIRM governing board on behalf of a
company(see here and here). It was the first time that the governing
board approved an application that had been rejected twice by grant
reviewers. It was the first time that the board said explicitly in a
public session that it wanted proof of the matching funds as a
condition of the award.
unusual in a number of ways. It was the first time that former CIRM
Chairman Robert Klein lobbied the CIRM governing board on behalf of a
company(see here and here). It was the first time that the governing
board approved an application that had been rejected twice by grant
reviewers. It was the first time that the board said explicitly in a
public session that it wanted proof of the matching funds as a
condition of the award.
It was the first time that a CIRM award
to a company received a careful and critical scrutiny from a major
California newspaper. Michael Hiltzik, a Pulitzer Prize-winning
business columnist and author, wrote in October in the Los Angeles
Times that the award was “redolent of cronyism.” He referred
particularly to longstanding ties between Klein and Weissman.
to a company received a careful and critical scrutiny from a major
California newspaper. Michael Hiltzik, a Pulitzer Prize-winning
business columnist and author, wrote in October in the Los Angeles
Times that the award was “redolent of cronyism.” He referred
particularly to longstanding ties between Klein and Weissman.
The CIRM board vote on the StemCells,
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.
In December, a blue-ribbon panel of the
Institute of Medicine (IOM) recommended that the agency tighten its
conflict of interest standards to avoid such perceptions as have been
generated by the StemCells, Inc., awards. The IOM said,
Institute of Medicine (IOM) recommended that the agency tighten its
conflict of interest standards to avoid such perceptions as have been
generated by the StemCells, Inc., awards. The IOM said,
“(C)ompeting personal and
professional interests compromise the perceived independence of
the (governing board), introduce potential bias into the board’s decision
making, and threaten to undermine confidence in the board.”
Concerns about conflicts of interest have long been of concern to observers of the stem cell agency for years. Indeed, the prestigious journal Nature in 2008 warned of "cronyism" at the $3 billion research enterprise.
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