Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems
By Dr. Matthew Watson
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.
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.”
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.
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.”
“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.'"
“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:
Stem Cell Therapy
Comments Off on Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems |
February 3rd, 2013
Stem Cell Agency Plan Falls Far Short of Solving IOM Concerns
By Dr. Matthew Watson
The governing board of the $3 billion
California stem cell agency last week fell far short of complying
with the recommendations of a blue-ribbon Institute of Medicine (IOM) study
that the agency itself commissioned to improve its performance.
with conflicts of interest at the eight-year-old agency, which board members
reluctantly recognized on Wednesday as a perception problem. Under the plan approved last week, 13 of the 29 members of the board would not be allowed to vote on any awards. They are members tied to institutions that benefit from funding. Three other board members linked to those beneficiary
institutions, however, would still be allowed to vote on grants other than
those to their institutions. .
structural issues involving conflicts of interest that are built into
the board as the result of Prop. 71, the ballot measure that created the research
effort in 2004. The 29-member board was constituted in such a way as
to give nearly all institutions that could benefit a seat at the
table where the money is handed out. It is as if the state's Public
Utility Commission, which sets utility rates, were dominated by
executives of the utility companies.
cell board are barred from voting on grants to their institutions. However, the board still determines the game and the rules. The board approves the
specific areas of research for funding, approves plans for individual
RFAS, sets the rules for the grants and loans and enforces compliance
through CIRM staff.
changes that it could enact on its own. Many of the IOM
recommendations, including a new majority of independent members,
would require legislative action, which opens the agency to a wider
range of changes than even the IOM recommended. That is not a prospect the agency relishes. Nonetheless,
how well the board complies with the IOM recommendations is likely to
be critical to its plans to raise funds to continue its operations
beyond 2017, when the taxpayer cash runs out for new grants.
More details may emerge between now the next CIRM board meeting in
the San Francisco Bay Area March 19, when the board is schedule to finalize its IOM plan.
of the Board and Working Groups.
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community....The chair and other
ICOC members should be prohibited from serving on the working groups.
During the reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.”
rejection of this recommendation. The CIRM board does not support
creation of a new majority of independent members, which would mean
some current members would lose their seats if the board were not
increased beyond 29 members. No members will be added from industry.
Board members will continue to serve on the grant review panel and
other groups, contrary to IOM recommendations. In the case of grant
reviews, however, they would no longer vote in the closed door
sessions. The board has no plans to add patient advocates who are not
board members to working groups, including the grant review panel.
The University of California will continue to have five guaranteed
seats on the board. No independent members currently sit on the
board.
Definitions and Policies.
of conflict of interest to recognize conflicts arising from
nonfinancial interests, such as the potential for conflict arising
from an individual’s interest in a specific disease, and should
reassess its policies for managing conflict of interest in light of
this broader definition.”
nonfinancial conflicts of interest. Several board members expressed
strong opposition to such an effort. Sixteen persons who sit on the
board have ties to institutions that receive CIRM funds. Currently
individual board members cannot vote on applications from their
institutions. To avoid the appearance of conflicts of interest, the
Thomas plan would have the 13 members directly appointed from
beneficiary institutions voluntarily abstain from voting on any grant
applications. Apparently not affected under the Thomas plan would be
three other board members who are appointed as patient advocates. Two
of them are employed by beneficiary institutions. The third is
chairwoman of the UC Board of Regents. All of the board members would
continue to vote on plans for all rounds of grants, including
determination of some of the specifics of the ensuing RFAs.
Funding Process.
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC (the agency's governing
board) should remain responsible for oversight and articulation of an
overall strategic plan. However, grant management, funding
recommendations, and grant administration should be the
responsibility of the CIRM scientific staff, reporting to the
president. This restructuring would help mitigate concerns related to
conflicts of interest and would also put the review and funding
process in the hands of those best equipped to make those decisions.”
serve on the grant review group would not vote on applications during
the grant review sessions. They would be limited to voting at public
board meetings. They would lead discussion of non-scientific
considerations for approval of applications during the public
sessions. Currently that occurs during the closed door review.
mechanism for public appeals of negative grant reviews.
behind closed doors. Currently extraordinary petitions are handled in
public board meetings, sometimes leading to lengthy, emotional
sessions with presentations by patient advocates. The public in
general, including grant applicants, continues to have the right
under state law to address the board on grant applications or any
other matter they wish.
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
should delegate day-to-day management responsibilities to the
president. Each of the three working groups should report to
management rather than to the ICOC.”
differ significantly from current operations, which reflect the
troubling dual executive arrangement involving the chairman and
president that was created by Prop. 71, the ballot measure that
created CIRM. The existing arrangement is also a hangover from the
days of the agency's first chairman, Robert Klein, and has been an
obstacle in previous recruitment efforts for a president of the
agency. The Thomas plan does eliminate a dual reporting arrangement
for the chief financial officer, a position that has been vacant
since last summer. Thomas indicated last fall that the position would
not be filled. Both the chairman of the IOM study panel and the
California state controller's office both say more needs to be done
to separate operations from oversight.
Key Aspects of CIRM Organization.
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group should be enhanced to leverage industry’s
expertise and resources in product development, manufacturing, and
regulatory approval in support of the ultimate goal of bringing
therapies to patients.”
involvement “where appropriate.” However, industry has complained
for years about this problem, and some board members as well. But
little has been done to deal with the problem. Recently, the agency
has taken some steps to engage industry, but the IOM was aware of
those when it made its recommendation for closer cooperation.
Board.
Scientific Advisory Board comprising individuals with expertise in
the scientific, clinical, ethical, industry, and regulatory aspects
of stem cell biology and cell-based therapies.” Members of this
board would be from out of state and replace existing advisory
boards. They would be appointed by and report to president.
of the a new board is under discussion, but generally indicated it
would go along this proposal. Not specifically addressed was
abolition of other advisory groups.
in consultation with current and future partners, including sources
of funding.
in consultation with current and future partners, including sources
of funding.
working on details of a plan.
Intellectual Property Policies in the Sustainability Platform.
continued impact of CIRM’s many achievements..., CIRM should
propose regulations that specify who will have the power and
authority to assert and enforce in the future rights retained by the
state in CIRM-funded intellectual property.”
Property Policies with Policies of Bayh-Dole Act.
cell research become available and as the field of regenerative
medicine advances from the laboratory to the clinic, the ICOC should
reconsider whether its goal of developing cures would be better
served by harmonizing CIRM’s IP policies wherever possible with the
more familiar policies of the Bayh-Dole Act.”
will review the policies and make recommendations.
Source:Stem Cell Therapy
Comments Off on Stem Cell Agency Plan Falls Far Short of Solving IOM Concerns |
February 3rd, 2013
CIRM’s Thomas: Conflicts ‘Put to Bed’ at Stem Cell Agency
By Dr. Matthew Watson
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.
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.
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.
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.
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.
“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.”
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.”
“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.”
“This puts the economic conflicts
issue to bed once and for all.”
Source:Stem Cell Therapy
Comments Off on CIRM’s Thomas: Conflicts ‘Put to Bed’ at Stem Cell Agency |
February 3rd, 2013
Loring on Patient Advocates and Their Role at the California Stem Cell Agency
By Dr. Matthew Watson
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.
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.
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.
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.
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.
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.
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.
made me a better scientist. Advocacy makes CIRM-funded research
breathtakingly relevant and uniquely powerful to change the course of
medicine.”
Source:Stem Cell Therapy
Comments Off on Loring on Patient Advocates and Their Role at the California Stem Cell Agency |
February 3rd, 2013
Patient Advocate Reed Defends Patient Advocates on Stem Cell Board
By Dr. Matthew Watson
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:Stem Cell Therapy
Comments Off on Patient Advocate Reed Defends Patient Advocates on Stem Cell Board |
February 3rd, 2013
IOM’s Shapiro Wants to See More Changes from California Stem Cell Agency
By Dr. Matthew Watson
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.
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.
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.”
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.”
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.
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.”
CIRM grantee carried a few brief items live from the meeting.
Source:Stem Cell Therapy
Comments Off on IOM’s Shapiro Wants to See More Changes from California Stem Cell Agency |
February 3rd, 2013
Stem Cell Agency Adds Fresh Details to IOM Response
By Dr. Matthew Watson
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.
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:Stem Cell Therapy
Comments Off on Stem Cell Agency Adds Fresh Details to IOM Response |
January 27th, 2013
Nature on the IOM and the California Stem Cell Agency
By Dr. Matthew Watson
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).
some of the IOM recommendations and the CIRM response. Baker wrote,
"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."
comments from John M. Simpson of Consumer Watchdog.
Source:Stem Cell Therapy
Comments Off on Nature on the IOM and the California Stem Cell Agency |
January 27th, 2013
California Stem Cell Agency to Pitch Newspaper Editorial Boards
By Dr. Matthew Watson
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.
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.)
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.”
Jeff Sheehy, a UCSF communications manager, urged engaging the
editorial boards.
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.
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:Stem Cell Therapy
Comments Off on California Stem Cell Agency to Pitch Newspaper Editorial Boards |
January 27th, 2013
Meager, Meager Coverage of Yesterday’s IOM-Stem Cell Meeting
By Dr. Matthew Watson
The $3 billion California stem cell
agency seemed all but invisible this morning in terms of mainstream
media coverage.
the watershed events yesterday at the CIRM governing board meeting at
the Claremont Hotel in Oakland – at least from what our Internet
searches show.
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.
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.”
cell agency often wonder about the lack of mainstream coverage of its doings,
particularly the lack of favorable coverage.
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.
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.
eyes in stem cell agency backers and others, but it is the reality of
today's news business.
Source:Stem Cell Therapy
Comments Off on Meager, Meager Coverage of Yesterday’s IOM-Stem Cell Meeting |
January 27th, 2013
Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations
By Dr. Matthew Watson
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.
Diego medical school.
Affymax
Francisco medical school
vice president of Genentech, appointed as executive officer of a
commercial life science entity
board of regents, appointed as patient advocate
chancellor, research, UC Irvine, and alternate for Sue Bryant,
interim provost at UC Irvine
Oakland
chancellor for research, political science professor, alternate for
the UC Berkeley chancellor
and patient advocate member of the board
patient advocate member
appointed as executive officer of a commercial life science entity
head of the Reeve-Irvine Research Center at UC Irvine
and Los Angeles bond financier
Sanford Burnham Research Institute
Claire Pomeroy, dean of the UC Davis medical school
Shlomo Melmed, senior vice president for academic affairs, Cedars Sinai
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:Stem Cell Therapy
Comments Off on Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations |
January 27th, 2013
Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More
By Dr. Matthew Watson
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 |
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.
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.”
said issues such conflicts of interest have “stolen focus” from
the good scientific work that the agency has funded.
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.
place for up to a one-year trial period, would not do all that the
IOM wanted, but would move strongly in that direction.
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.
- 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.
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.'"
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.
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
Stem Cell Therapy
Comments Off on Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More |
January 27th, 2013
Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations
By Dr. Matthew Watson
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.
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. |
“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.”
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.
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.
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.
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.
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:Stem Cell Therapy
Comments Off on Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations |
January 20th, 2013
StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency
By Dr. Matthew Watson
million it was awarded by the California stem cell agency.
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.
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.
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.
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.
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.
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.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5BdZ8FguJp8/stemcells-inc-still-looking-for-40.html
Stem Cell Therapy
Comments Off on StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency |
January 20th, 2013
UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency
By Dr. Matthew Watson
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.
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
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.
actually make CIRM less effective and less responsive to patients and
California citizens.”
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.”
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."
“(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.”
“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).”
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.
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 Therapy
Comments Off on UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency |
January 20th, 2013
Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency
By Dr. Matthew Watson
California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.
 |
| Reed and CIRM's Amy Adams World Stem Cell Summit photo |
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency, formally known as the California Institute for Regenerative
Medicine(CIRM).
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,
“If its recommendations were enacted,
they would silence stem cell patient advocate involvement, eliminate
public debate on funding proposals, and delegate the real decisions
to secret proceedings by an out-of-state-controlled board.”
“fantastic” and wrote,
“So why mess with it, in such a
brutal and insulting manner?”
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.
“(We will) never convince the people
that are adamant against us. But for the public and for the
constituent groups that are reasoned and prepared to look at
evidence, this is a very important validation that they can look to
to separate out what is a false claim from real performance.”
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.
plans to file his own story within the next few days.
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/wX7BEi46lc8/patient-advocate-says-iom.html
Stem Cell Therapy
Comments Off on Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency |
January 20th, 2013
California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations
By Dr. Matthew Watson
Two days next week at the posh
Claremont Hotel in the Berkeley hills could settle the fate of
California's $3 billion stem cell agency.
board of the state research effort will begin a critical, two-day
public session. On the table will be the $700,000, blue-ribbon
report from the prestigious Institute of Medicine (IOM). The study
recommends sweeping changes in the structure and operations of the
California Institute of Regenerative Medicine (CIRM), as the stem
cell agency is formally known.
challenges for the agency. But the recommendations are freighted with
even more significance. Below the surface lies the hard fact of
CIRM's dwindling resources and possible demise. In less than four
years – without either renewed public support or private
contributions – the research effort will begin a shriveling,
downward spiral.
 |
| Claremont Hotel |
The IOM report places a special burden
on the agency governing board. The board paid the IOM to evaluate its
performance. In 2010, then CIRM Chairman Robert Klein trumpeted the
value of an IOM study, saying it would serve as a springboard for a
new, multibillion-dollar state bond measure for the agency(see here and here). Given the
state's difficult financial condition – not to mention the position
of potential private sector investors – winning approval of that
kind of investment will be more than difficult.
directors choose to ignore the major IOM recommendations, they will
hand opponents a devastating weapon, one that could be used to convince voters to reject
any proposal for continued funding. The board
would also give private investors more major reasons to say no to
CIRM pitches for cash.
board has rejected similar proposals for changes in the past. When
the IOM presented the study to the board just last month, the
reception was not much different. Several board members bristled. One
influential board member, Sherry Lansing, chair of the University of
California board of regents, said the directors' “hands are tied”
because some of the recommendations might require a vote of the people. Her comments echoed similar statements from Klein in 2009,
when he said board members would violate their oath of office if they
supported recommendations for changes that he opposed.
however, was relatively brief and less than definitive. Klein has
been off the board since June 2011, replaced by Los Angeles bond
financier Jonathan Thomas, who is regarded as a welcome change by a
number of board members.
within the agency itself. Conflict of interest rules would be
tightened. In some ways, the board would lose power, which would be
shifted to the president. The board would no longer vote on
individual applications – only a slate recommended by reviewers.
Applicants for CIRM awards would be directly affected, being barred
from making the sort of direct and public appeals that clogged the
CIRM board meetings last year. And that would be just the beginning.
to make his recommendations for action on the report, although they
have not yet been posted on the CIRM web site. Under what might be considered “normal” leadership, Thomas would be testing sentiment
among board members via personal conversations and phone calls.
However, in California that would be illegal – a violation of open
meeting laws that bar what are called “serial meetings” at nearly
all public agencies.
majority vote for anything significant among 29 strong-minded
individuals is not simple. But it is even more difficult when facing
a board that has a tradition of consensus management and
oversight.
interesting. The nearly 100-year-old, iconic Claremont hotel has a
troubled financial history. It was up for sale for $80 million last
spring but there were no takers. In the early 20th century, the
property on which it is located was lost and won in a checkers game
in Oakland, or so the story goes.
California stem cell agency. Moves next week by directors could
easily determine whether CIRM becomes nothing more than an
interesting scientific footnote or establishes a path that will lead
it to long-lasting leadership in regenerative medicine.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SS09uwQmVDQ/california-stem-cell-face-off-cirm.html
Stem Cell Therapy
Comments Off on California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations |
January 20th, 2013
Live Audiocast Available for Next Week’s CIRM-IOM Meetings
By Dr. Matthew Watson
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.
Source:Stem Cell Therapy
Comments Off on Live Audiocast Available for Next Week’s CIRM-IOM Meetings |
January 20th, 2013
Nature Biotechnology: California Stem Cell Agency Receives ‘Stinging Rebuke’
By Dr. Matthew Watson
Biotechnology read: “IOM smacks down California Institute of
Regenerative Medicine.”
DeFrancesco said that the $3 billion California stem cell agency
“received a stinging rebuke of much of the way it has been carrying
out its business by a group of independent reviewers.”
the blue-ribbon, Institute of Medicine panel “praised the courage
and vision of the individuals who spearheaded the program as well as
those toiling in the CIRM office in San Francisco.”
familiar ground for many readers, summarizing the IOM's sweepingrecommendations last month, including those dealing with the built-in
conflicts of interest on the agency's 29-member governing board.
whether the agency will move to adopt any of the recommendations from
the panel, many of which have been rejected in the past.
board last month bristled at some of the recommendations. The board is scheduled to discuss the IOM report, for
which it paid $700,000, at a public meeting Jan. 23 in Berkeley.
Patient advocates are already organizing a turn-out to lobby against
some recommendations.
Source:Stem Cell Therapy
Comments Off on Nature Biotechnology: California Stem Cell Agency Receives ‘Stinging Rebuke’ |
January 13th, 2013
Roman Reed is Stem Cell Person of 2012; Leigh Turner Runner-up
By Dr. Matthew Watson
Roman Reed, a Fremont, Ca., patient advocate, this week was named Stem
Cell Person of 2012 by the Knoepfler Stem Cell Lab at UC Davis, which
cited Reed for energizing a new generation of
advocacy.
 |
| Roman Reed (left) and Paul Knoepfler Knoepfler Lab photo |
Knoepfler awarded Reed $1,000 from his personal funds. The ceremonial
check appears to be close to four-feet long in a photo taken in
Knoepfler's lab.
made a “tremendous difference” in 2012. The researcher said,
“One of the most notable was
catalyzing the TJ Atchison Spinal Cord Injury Research Act in
Alabama, which provides $400,000/year in funding for research. Of
course, TJ and many others who helped make this possible also deserve
great credit and have my admiration, but Roman provided key
leadership. Here in California, Roman’s Law supported its 11th
year of grants all eligible for all forms of stem cell research.
Roman informs me that it funded $749,00 overall and approximately
$200,000 in stem cell funding.
“In addition, Roman in 2012 mentored
and energized a whole new generation of advocacy from young,
energetic leaders: TJ Atchison, Katie Sharify, Richard Lajara
and Tory Minus.”
but also conducted an advisory poll that Reed won. Knoepfler wrote,
 |
| Leigh Turner U of Minn photo |
“Only 6% behind Roman was the amazing
activist Ted Harada followed by Roman’s dad the remarkable Don
Reed, the wonderful Judy Roberson, and the super Katie Sharify nearly
all tied for third. Next after them was the relative new kid in stem
cell town, Leigh Turner.”
professor at the Center for Bioethics at the University of Minnesota,
as the official runner-up in the contest, No. 2 behind Reed.
Knoepfler wrote,
“Leigh took the courageous,
outside-the-box step in 2012 of contacting the FDA to investigate
Celltex when he perceived patients could be at risk. As “thanks”
for his action, he was put under enormous pressure and there was talk
of possible litigation against him. Pressure was applied to his
employer, the University of Minnesota. We’ll never know for sure,
but from everything that I know I believe that Leigh’s actions
directly led to prompt FDA action, which otherwise might not have
happened at all or until much later. In my opinion, Leigh’s act of
courage, helped make hundreds of patients safer in a direct way and
indirectly may have set a higher standard for the field of stem cell
treatments.”
Source:Stem Cell Therapy
Comments Off on Roman Reed is Stem Cell Person of 2012; Leigh Turner Runner-up |
January 13th, 2013