San Diego Newspaper Hails Stem Cell Agency and IOM Response
By Dr. Matthew Watson
The $3 billion California stem cell
agency hit it big in San Diego today, finally scoring an editorial
that said “arguably” the agency's largess has made the state “the
world leader in medical research.”
circulation newspaper in the area, said the big headline about the
eight-year-old agency is “the potential for transformative medical
breakthroughs.”
long been criticized in connection with conflicts of interest. About
90 percent of the $1.8 billion the agency has awarded has gone to
institutions linked to current and past members of its board of
directors.
criticism seriously,” the newspaper said. It cited proposals that
would, if approved later this month, have 13 members of the agency's
governing board voluntarily abstain from voting on any grants that come before
the board. Twenty-nine persons sit on the board. The thirteen are
connected to recipient institutions. Two other board members are
linked to recipient institutions.
matter in San Diego, which is one of California's hotbeds of biotech
and stem cell research. The stem cell agency has awarded about $338
million to San Diego area institutions and businesses. Four
executives from San Diego area institutions sit on the CIRM board.
“There
remains a residue of cynicism about CIRM. Critics say the agency
board did the minimum necessary to avoid an intervention by the
Legislature – and also acted to buff the agency’s image should it
seek more bond funding from California voters before its present
funding runs out in 2017, as is now projected.
“These views
may have some merit. But on balance, we think the California
Institute for Regenerative Medicine has – at long last –
responded properly to the fair criticism it faced. Instead of being
exasperated by CIRM, more people should be excited about the great
work it is doing.”
involving the editorial board of the newspaper, CIRM Chairman
Jonathan Thomas and Larry Godlstein, director of the UC San Diego stem
cell program. The meeting was part of a CIRM campaign to generate
newspaper support for the agency's response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. The San Diego editorial is the most effusive so far.
Bradley Fikes, sat in on the meeting and Saturday posted video excerpts from the discussion, including a brief written summary of the content of each clip.
Source:
Stem Cell Therapy
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March 17th, 2013
California Stem Cell Directors to Finalize IOM Response Next Week
By Dr. Matthew Watson
Directors of the California stem cell
agency will meet March 19 in Burlingame to complete action on
their response to blue-ribbon recommendations for sweeping changes at
the eight-year-old research enterprise.
told the San Diego U-T editorial board that he regarded approval as
“largely ministerial.”
editorial boards around the state, touting his plan, which was
initially approved by the board in January. The main focus has been
on its provisions dealing with conflicts of interest, which would
have 13 of the 29 governing board members voluntarily remove themselves from
voting on any grant applications. The 13 are linked to recipient
institutions. Two other board members linked to recipient
institutions also sit on the board.
that has been awarded by the CIRM board has gone to institutions
linked to past and present members of the board.
problems with conflicts at the stem cell agency. It recommended
creation of a new, independent majority on the board, which would
mean that some members would lose their seats. The IOM report also
recommended a host of additional changes that have become eclipsed by
the controversy about conflicts, which were built into the board by
Proposition 71, the ballot measure that created it in 2004.
California Stem Cell Report of the IOM report, which CIRM
commissioned at a cost of $700,000, showed that agency's response fell far short of what the IOM proposed to improve the agency's
performance.
approval of applications in a $30 million effort by the agency
involving reprogrammed adult stem cells. The agency said the goal of
the initiative is “to generate and ensure the availability of high
quality disease-specific hiPSC resources for disease modeling, target
discovery and drug discovery and development for prevalent,
genetically complex diseases.”
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FH7dzoNWS8c/california-stem-cell-directors-to.html
Stem Cell Therapy
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March 17th, 2013
Public Banned from ‘Best Stem Cell Meeting in the World’
By Dr. Matthew Watson
“The best stem cell meeting in the
world” is underway today in San Francisco – conducted at taxpayer
expense – but the public is barred from attending.
representatives of biotech firms. And the meeting is even being
written about on the internet by a blogger. But the $3 billion
California stem cell agency says the public is not allowed in because
some of the information is “proprietary.”
the meeting earlier this week and declared it was “the best stem
cell meeting in the world,” according to UC Davis researcher Paul
Knoepfler, who is reporting from the session on his blog.
of the recipients of taxpayer-funded grants given by the stem cell agency although a number of
businesses have been brought in.. CIRM, which is paying for the gathering, says of the annual sessions,
“The purpose of meeting is to bring together investigators funded
by CIRM, to highlight their research, and encourage scientific
exchange and collaboration.”
agency, today said the public was barred from the meeting, which ends tomorrow, because “so
many presentations/talks (are) using proprietary information.”
world of science. But there is no chance of maintaining secrecy about anything that is
truly proprietary when hundreds of people have access to it in
this sort of forum. No penalties exist for disclosure, plus the whole
point of the session is to share information.
it, the stem cell agency is a government operation. We doubt that
anything egregious is underway at the session, but closing it to the
public is a reminder about where the agency's priorities lie.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uiwodYaNIP8/public-banned-from-best-stem-cell.html
Stem Cell Therapy
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March 10th, 2013
Good News, Bad News and the California Stem Cell Agency
By Dr. Matthew Watson
A few weeks ago an anonymous reader
admonished the California Stem Cell Report to be more positive about
the $3 billion agency and its efforts to develop the cures that its
backers promised California voters more than eight years ago.
out that “almost all the time” the agency “has done the right
thing.” The reader made the remarks in the context of continuing
coverage of the Institute of Medicine (IOM) report that found there
were major flaws in CIRM's operations. (The reader's comment can be found here at the end of the post.)
good time to review the operating principles and biases of the
California Stem Cell Report.
come first in any government operation. They are
fundamental to the integrity of all government enterprises. Bias No.
2: The California stem cell agency is generally doing a good job at
funding stem cell research. We generally favor all manner of stem cell research.
goal is report news and information about the agency along with
analysis and explanation. One key to understanding what this blog
does is to understand what news is. News by definition is almost
always “bad” as opposed to “good.” News deals with the
exceptional. It is not news that millions of drivers commute to work
safely each day on California freeways. It is news when one is killed
in a traffic accident.
tries to fill information voids. We understand that the stem cell
agency believes certain information is not in their best interests to
disclose. Such is always the case with both private and public
organizations. However, it is generally in the public interest to see
more information rather less, particularly information that an
organization would rather not see become public.
nationally or internationally. This blog focuses primarily on the
public policy aspects of the agency – not the science. The agency
is an unprecedented experiment that brings together big science, big
government, big academia, big business, religion, morality, ethics,
life and death in single enterprise – one that operates outside the
normal constraints of state agencies. No governor can cut CIRM's
budget. Nor can the legislature. Even tiny changes in Proposition 71,
which created CIRM, require either another vote of the people or the
super, super-majority vote of both houses of the legislature and the signature of the governor. All of
this is the result of the initiative process – a well-intended tool
that has been abused and that has also created enormous problems for the
state of California that go well beyond the stem cell agency.
agency, which basically lives off the state's credit card. All the
money that goes for grants is borrowed and roughly doubles the actual
expense to taxpayers.
3,452 items on the stem cell agency because we believe the California
Institute for Regenerative Medicine (CIRM) is an important enterprise
– one that deserves more attention that it receives in the
mainstream media. Our readership includes persons at the NIH, the
National Academy of Sciences, most of the major stem cell research
centers in California, academic institutions in the Great Britain,
Canada, Norway, Germany, Russia, China, Australia, Singapore and
Korea – not to mention the agency itself and scientific journals.
California stem cell agency itself does, which is to post online a
prodigious amount of positive stories and good news about the agency.
To do so would serve no useful public purpose and would simply be
repetitive. That said, there is room to acknowledge the work that the
agency does, particularly the staff, but also the board. We try to
point that out from time to time.
welcomes and encourages comments, anonymous and otherwise. Directors
and executives of the agency have a standing invitation to comment at
length and have their remarks published verbatim, something almost
never seen in the mainstream media.
the Institute of Medicine about disclosure of potential conflicts of
interests, the author of this blog and his immediate family have no
financial interests in any biotech or stem cell companies, other than
those that may be held by large mutual funds. We have no relatives
working in the field. We do have the potential personal conflicts,
cited generally by the IOM in connection with some CIRM board
members, involving relatives who have afflictions that could be
possibly be treated with stem cell therapies in the distant future.
Source:Stem Cell Therapy
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March 10th, 2013
LA Times: Stem Cell Agency Conflict-of-Interest Response Only a Bandage
By Dr. Matthew Watson
The Los Angeles Times yesterday modestly praised the $3 billion California stem cell agency for
taking some limited steps to deal with its longstanding conflict of
interest issues.
needed if the agency plans to have a life after 2017, when funds for
new awards run out.
“After years of resisting all
criticisms of its operations, the California Institute for
Regenerative Medicine is finally listening — a little.“
“Yet the agency isn't exactly
embracing an ethical overhaul. It's doing just enough to address the
criticisms without triggering any oversight from the Legislature. The
modifications are more a bandage than a cure. Like a bandage, they
will probably do, but only for a limited time.”
members with ties to recipient institutions voluntarily refrain from
voting on any grants that come before the board, not just the ones to
their institutions.
report from the Institute of Medicine identified the make-up of the
board as the “single biggest problem” at the agency. The
editorial cited figures prepared by the California Stem Cell Report
that show that about 90 percent of the $1.8 billion that the board
has awarded has gone to institutions linked to current or past
members of the board. Fifteen out of the 29 current board members
have ties to recipient institutions.
“If the stem cell institute is just a
temporary agency that will last until its public funding runs out —
it plans to give its last grants with existing funds in 2017 — its
planned reforms will probably be enough. But if the institute wants
to be a permanent part of the research landscape — and possibly ask
for more public funding — voluntary recusals are an inadequate
patch. The agency's leaders should admit that the original setup was
flawed and seek a true fix. “
Source:Stem Cell Therapy
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March 3rd, 2013
CIRM Director Prieto on Disclosure of Reviewer Financial Interests
By Dr. Matthew Watson
A member of the governing board of the
$3 billion California stem cell agency is weighing in on an item on
the California Stem Cell Report that called for public disclosure of the financial interests of the scientific reviewers, who make 98
percent of the decisions on awards by the agency.
physician and a patient advocate member of the board, said in an email:
“ It seems to me there's a bit
of 'damned if we do and damned if we don't' here. If the ICOC (the
agency governing board) decides to listen to some of the members of
the public who come to our meetings and overrule a recommendation of
the Grants Working Group(GWG), we're slammed for letting emotion trump
science, or bowing to special interests. If we just accept the
rankings of the GWG and approve all their recommendations, we're
criticized for not being truly independent. I think we don't do
it often (for good reason) but should and do retain the right to look
at other factors besides those our scientific reviewers do, and make
our own decisions about funding. We are ultimately responsible, not
the scientific reviewers.
“As for the issue of their
disclosure of personal conflicts of interest, from what I've read of
the NIH processes, ours are no less strict. The NIH requires that
reviewers disclose any conflicts to their institutions which I
believe must disclose them to the NIH, but I have not seen anything
requiring them to disclose all their personal financial & other
interests publicly, as we (ICOC members) have to. When we were
assembling our group of reviewers initially, the fear was that many
of the best scientists would turn us down if we required them to make
the kind of personal disclosures we have to. I don't know how many we
might actually lose if that were the case, but as you know we do
require them to disclose to CIRM, and they have to leave the room
when any application for which they have a conflict is discussed.”
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
on this important subject.
Source:Stem Cell Therapy
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March 3rd, 2013
California Stem Cell Agency Bonds On Sale in March
By Dr. Matthew Watson
Early next month, the state of
California will sell $2.7 billion in bonds, a tiny fraction of which will go
towards the California stem cell agency.
currently involves short-term borrowing as well to keep the cash
pipeline at CIRM properly filled.
subsists off money that the state borrows (bonds) instead of going to
the legislature annually for financial support. While that avoids
competing against school children, the poor, the University of
California, state colleges, parks, highways and other interests
seeking state funding, it also means that the cost of a $20 million
grant is something closer to $40 million because of the interest
expense.
week asked the state treasurer's office about the bond sale March
12-13 and what it means for the stem cell agency. Here is what Tom
Dresslar, spokesman for the treasurer, replied in an email.
“CIRM’s funding needs now are met
via the issuance of commercial paper (CP). They’re authorized
a certain amount of CP periodically. Then we work with them on
a regular basis to issue the commercial paper on an as-needed basis.
Last fall, they were authorized $160 million of CP. We will
issue the first $27 million under that authorization (this) week.
This spring, CIRM is scheduled to receive another $100 million
authorization. The Department of Finance , consulting with CIRM
officials, determined the $100 million would be needed to meet CIRM’s
funding requirements through the end of 2013.“Now, here’s where it gets a little
complicated. The state pays down the CP with bond proceeds.
The March ....bond sale includes $60 million of stem
cell bonds. Those proceeds won’t provide new money for CIRM,
but will pay down the CP proceeds CIRM already has used.”
cell agency in 2004, authorized bond sales for stem cell research for
only 10 years. CIRM's financial timekeepers say the clock started
running when the first bonds were sold. The upshot is that the agency
will run out of money for new grants in less than four years.
Source:Stem Cell Therapy
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March 3rd, 2013
California Stem Cell Agency: Comparing the Critiques
By Dr. Matthew Watson
State Controller John Chiang has posted
a useful, side-by-side comparison of critiques of the $3 billion
California stem cell agency, including the Institute of Medicine(IOM)
study, along with the responses from the agency.
has additionally posted the initial remarks Jan. 23 by CIRM Chairman
Jonathan Thomas before the stem cell agency governing board on his
plan to deal with the sweeping recommendations of the IOM.
board's response to the IOM, Thomas adroitly handled the discussion
and vote, not a small accomplishment given the size of the board (29
members) and the legal restrictions involving public meetings. Under
state law, Thomas could not lobby significant numbers of the board in
advance of the meeting. He was restricted to engineering the approval
in a public session, which can easily take on a life of its own given
the unwieldy size of the board and the necessity for public comment.
he is chairman of the Citizens Financial Accountability and Oversight
Committee, the only state body specifically charged with oversight of
the agency and its board. The web site for the committee is the only
location on the Internet where Thomas' prepared remarks and the
comparison can be found.
only the IOM study, but last year's performance audit and the Little
Hoover Commission study in 2009. Missing, however, is the state
auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.
documents: Thomas' prepared comments, Power Point chart used by Thomas,
comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.
Source:Stem Cell Therapy
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March 3rd, 2013
City of Hope Exec Will Leave California Stem Cell Agency Board
By Dr. Matthew Watson
 |
| Michael Friedman City of Hope photo |
California stem cell agency will lose another one of its veteran
members this year – Michael Friedman, the CEO of the City of Hope
in the Los Angeles area.
the board. Pomeroy is resigning as vice chancellor of Human Health
Services at UC Davis this spring to become president of the Lasker Foundation in New York.. Friedman is retiring at the end of this year.
its first meeting in December 2004. Pomeroy was appointed by the UC
Davis chancellor. Friedman was appointed by the state treasurer.
likely successors. However, the UC Davis chancellor is required by
law to appoint an executive officer from the campus. The new dean at
the UCD medical school would seem to be the most likely candidate.
Lockyer must appoint an executive officer from a California research
institute. The tradition on the board has been for particular
institutes to hold particular seats on the board. The major exception
is the Salk Institute, which lost a seat on the board a few years
back.
benefited enormously from CIRM largess. UC Davis has received $131
million and the City of Hope $51 million. Although Friedman and
Pomeroy have not been allowed to vote on grants to their
institutions, their presence and the presence on the board of other executives
from beneficiary institutions has triggered calls for sweeping changes at the agency.
of Medicine said “far too many” board members are linked to
institutions that receive money from CIRM. The institute recommended
that a new majority of independent members be created on the board.
California Stem Cell Report, about 90 percent of the $1.8 billion the
board has awarded has gone to institutions with ties to past and
present board members. Fifteen of the 29 members of the board, which
has no independent members along the lines suggested by the IOM, are
linked to recipient institutions.
before money for new awards runs out in less than four years.
Source:Stem Cell Therapy
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February 24th, 2013
Monitoring the Cash and IP at the California Stem Cell Agency
By Dr. Matthew Watson
The $3 billion California stem cell
agency appears unlikely to make any changes in who gets the cash from
any commercial products that its research grants help finance despite
recommendations from the Institute of Medicine(IOM).
during a meeting of the intellectual property subcommittee of the
governing board of the stem cell agency. Intellectual property (IP) simply
determines ownership rights and the share of any revenue from
therapies that result from research.
teleconference locations in La Jolla, Los Angeles, two in Irvine
along with the main site in San Francisco.
recommendations in this fashion:
“Because CIRM is a new institution
without a track record to reassure stakeholders, and because its
finite funding timeline means as yet unknown agencies will be
enforcing these policies years down the road, CIRM should “propose
regulations that specify who will have the power and authority to
assert and enforce in the future rights retained by the state” in
CIRM IP, specifically referring to march-in rights, access plans and
revenue sharing....
“Second, as other sources of funding
become more prevalent, the agency should “reconsider whether its
goal of developing cures would be better served by harmonizing CIRM’s
IP policies wherever possible with the more familiar policies of the
BayhDole Act.”
recommendations.
“CIRM staff has engaged in
preliminary discussions several years ago with other agencies
regarding future enforcement of CIRM’s regulations and agreements.
Staff proposes to restart those discussions and return to the
Subcommittee (or the Board) with a formal proposal to address future
enforcement of CIRM’s IP regulations.”“In light of the IOM’s own
recognition that it may be premature to assess whether CIRM’s
regulations will act as a deterrence to future investment, the fact
that a number of CIRM’s regulations have been codified in statutes
and CIRM’s positive progress in its industry engagement efforts to
date, although quite early, CIRM staff proposes to continue to
monitor this area and not to pursue any changes at this time.”
to diverge significantly from the staff proposal, which was dated
Feb. 14 but not posted on the CIRM website until Feb. 20.
Source:Stem Cell Therapy
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February 24th, 2013
Half-full, Half-empty Editorial on California Stem Cell Agency
By Dr. Matthew Watson
The California stem cell agency's
editorial road show paid off a bit again this week with a mildly
approving editorial in the Oakland Tribune.
of Jonathan Thomas, a Los Angeles bond financier, as chairman of the
$3 billion agency has improved things, compared to the reign of Bob
Klein, who “built a protective shield” around the agency's
governing board and prevented action to deal with obvious
conflict-of-interest problems.
extent” the agency has brought “cutting edge” scientists to the
state and helped boost the stem cell field.
editorial. The half-empty side included the headline.
“California
must get its stem cell house in order”
“...{T)he agency must prove that it
understands how to properly handle the public's money. …. If
the stem cell agency can establish a record as a good steward of
public dollars to finance brilliant science, it can continue to play
a useful role in stimulating and guiding research to bring the
potential cures from stem cell research to fruition.
“If it cannot do that, it will be
just another expensive Tyrannosaurus rex.”
editorial doors around the state in hopes of building support for the
board's modest – some might say inadequate – response to
recommendations for sweeping changes at the agency.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tMt6gs55Yvs/half-full-half-empty-editorial-on.html
Stem Cell Therapy
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February 24th, 2013
Time For Public Disclosure of Financial Interests of Stem Cell Agency Reviewers
By Dr. Matthew Watson
Should the scientists who evaluate
and score the applications for $3 billion in taxpayer funds be
required to publicly disclose their financial interests?
agency, despite concerns by the state auditor and the state's Fair
Political Practices Commission (FPPC) that date back at least six
years. The agency says that its governing board makes the decisions
on the applications – not the grant reviewers – and that the
members of the board fully disclose their economic interests.
a document that sheds new light on the issue. The document confirms
that the board rubber-stamps virtually all the reviewers' decisions,
going along with their actions 98 percent of the time. The board
exercised independent judgment on 28 out of 1,355 applications.
“(T)he FPPC believes that, under
state regulations, working group members (including grant reviewers)
may act as decision makers if they make substantive recommendations
that are, over an extended period, regularly approved without
significant amendment or modification by the committee. Thus, as
decision makers, working group members would need to be subject to
the conflict-of-interest code. This would mean that working groups
would be subject not only to the (public) financial disclosure requirements of
the Political Reform Act but also to the prohibition against a member
participating in a government decision in which that member has a
disqualifying financial interest and may be subject to the penalties
that may be imposed on individuals who violate that act.”
cell agency seek an attorney general's opinion on the matter, a
recommendation the agency agency summarily dismissed seven months later..
President Richard Murphy, a former member of the agency's board and
former president of the Salk Institute, replied to the auditor:
"We have given careful
consideration to your recommendation and have decided it is not
appropriate to implement at this time. In almost three years of
operation and approval of four rounds of grants, the recommendations
of the CIRM working groups have never been routinely and/or regularly
adopted by the ICOC. Until the time that such a pattern is detected,
the question you suggest we raise with the attorney general is
entirely hypothetical, and is therefore not appropriate for
submission. We will, however, continue to monitor approvals for such
a pattern and will reconsider our decision if one emerges."
Murphy's response, 100 percent of reviewer decisions were
rubber-stamped by the board. In the other two rounds, the percentage
was 95 and 96 percent.
of interest in private to selected CIRM officials. (See policy here.)
From time to time, grant reviewers are excused from evaluating
specific applications.
requiring public disclosure of the interests of reviewers. The subject
has come up several times, but board members have been concerned
about losing reviewers who would not be pleased about disclosing
their financial interests. Nonetheless, disclosure of interests among researchers is becoming routine in scientific research articles. Many universities, including
Stanford, also require public disclosure of financial interests of
their researchers. Stanford says,
“No matter what the circumstances --
if an independent observer might reasonably question whether the
individual's professional actions or decisions are determined by
considerations of personal financial gain, the relationship should be
disclosed to the public during presentations, in publications,
teaching or other public venues.”
of interest rules are under review by the FPPC. They do not include
any changes in public disclosure for grant reviewers. In view of the
new information that confirms that reviewers are making 98 percent of
the decisions on who gets the taxpayers' dollars, it would seem that it is long past due for public disclosure of both financial and professional
interests of reviewers. Indeed, given the nature of scientific
research and the tiny size of the stem cell community, disclosure of
professional interests may be more important than financial
disclosures.
said concerning his organization's own strengthening of disclosure requirements,
"The public trust in what we do is
just essential, and we cannot afford to take any chances with the
integrity of the research process."
reviewers' decisions and governing board action. The table has not
been posted on the CIRM website, but it was prepared for last month's
meeting dealing with the Institute of Medicine's recommendations for
sweeping changes at the agency, especially related to conflicts of
interest.
Source:Stem Cell Therapy
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February 24th, 2013
San Jose Newspaper Lauds CIRM Chairman Thomas
By Dr. Matthew Watson
The California stem cell agency got some good
news this week. The San Jose Mercury News ran an editorial yesterday
that was headlined,
|
Source:Stem Cell Therapy
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February 17th, 2013
No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim
By Dr. Matthew Watson
Earlier
this month the California Stem Cell Report published an item that said:
“In
the wake of recent considerable criticism concerning conflicts of
interest at the $3 billion California stem cell agency, its leaders
have taken to saying 'no actual conflicts' have been found at the
agency.
“That
assertion is simply not true.”
asked the stem cell agency if it would like to respond and said that
its response would be carried verbatim. The agency's comments are below. Our
take on the response follows the CIRM comments, which were authored
by Kevin McCormack, the agency's senior director for public
communications and patient advocate outreach.
David Jensen’s recent blog about the stem cell agency he claims to
“debunk” claims that there have been no actual conflicts in
CIRM’s funding decisions saying “the agency has a long history of
problems involving conflicts of interest, 'actual' and otherwise.”
In fact, in the cases cited by Mr. Jensen, show 'otherwise' is the
appropriate word here because as we’ll show CIRM’s conflict
procedures worked and the funding decisions were not affected by any
improper influence.
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
Reed
2007, John Reed, a member of the stem cell agency’s Governing
Board, contacted staff in his capacity as the president of the
Burnham Institute after the Board approved a SEED grant award to a
Burnham investigator. Dr. Reed did not participate in the Board’s
decision to approve the award and played no role in that decision.
All he did was send a letter to CIRM staff after the Board meeting to
provide factual information in response to technical questions raised
by CIRM staff concerning the investigator’s eligibility for an
award. Those questions ultimately led staff to reject the grant.
Because the Board had already made the decision to award the grant,
it did not occur to Dr. Reed that the conflict rules would prevent
him from contacting staff to provide relevant information. And why
would it? The decision was made so there was nothing to influence.
After CIRM staff received Dr. Reed’s letter, they informed Dr. Reed
that he must refrain from participating in any way in CIRM's
consideration of the Burnham grant. In addition, CIRM staff did not
consider the letter in conducting their administrative review of the
Burnham grant and their determination that the investigator was not
eligible did not change. The FPPC determined that, although Dr.
Reed’s conduct raised ethical concerns, he had not violated
conflict of interest laws because he attempted to influence a
decision that had already been made. Furthermore, Dr. Reed’s
conduct did not affect a CIRM funding decision because the grant was
rejected by CIRM staff.
Faculty Awards
a candidate applies for a CIRM New Faculty Award it is standard
practice for them to include a letter of support from the institution
where they hope to be working. In December 2007, during a review of
applications for New Faculty Awards, CIRM staff discovered that ten
applications were accompanied by letters of institutional support
signed by members of the Board. This was due to a miscommunication by
staff, a poorly drafted memo to Board members leading them to think
it was OK to sign the letters of institutional support. The error was
discovered before the Board considered any of the applications. CIRM
staff determined that the letters could be perceived to create a
conflict of interest and so, to avoid even the appearance of a
conflict, CIRM staff disqualified the ten applications. As a result,
the applications were not presented to the Board for its
consideration, thereby avoiding any potential for a conflict of
interest in a funding decision.
Sladek
2011, while preparing the public summary for Basic Biology III
applications, CIRM staff discovered that Dr. John Sladek was one of
several co-authors on scientific publications with a researcher who
was listed as a consultant on a CIRM grant application. This is a
technical violation of the Grants Working Group (“GWG”) conflict
policy, which prohibits a member of the GWG from participating in the
review of an application if the member has co-authored papers with a
salaried investigator listed on a CIRM application within a three
year window. It should be noted, however, that Dr. Sladek’s
participation in the review of the application would not have
constituted a conflict of interest under state conflict of interest
laws because Dr. Sladek did not have a financial interest in the
application. In addition, the amount of funding involved –
approximately $3,000 of salary per year for three years, less than
one percent of the total award – was not material, and Dr. Sladek
did not stand to receive any financial benefit from the application.
Finally, Dr. Sladek’s participation in the review did not affect
the outcome because the application was not recommended, or approved,
for funding.
three instances cited by Mr. Jensen share two common features.
First, CIRM staff identified the potential for a conflict before any
funding decision was made. Second, CIRM’s funding decisions were
not affected by any improper influence.
Love
Jensen also cites the service of Dr. Ted Love, a member of the Board
who volunteered his time to assist CIRM in offering his scientific
and medical expertise, as evidence of a conflict of interest.
Although Mr. Jensen insinuates that Dr. Love’s service constituted
a conflict of interest, he does not cite any facts, except Dr. Love’s
“deep connections to the biomedical industry.” But the fact that
Dr. Love has experience in the biotech industry does not constitute a
conflict of interest, and as a member of the Board and as a volunteer
to CIRM, Dr. Love abided by CIRM’s conflict of interest policies.
the past Mr. Jensen has criticized the stem cell agency for its lack
of connections and engagement with industry. In this case he
criticizes us precisely because of our connection and engagement with
someone who has industry experience.
Capital Firm
Jensen also suggests that a conflict of interest arose from the fact
that “iPierian,Inc., whose major investors [a venture capital firm]
contributed nearly $6 million to the ballot measure that created the
stem cell agency, has received $7.1 million in awards from the
agency.” While it is true that Proposition 71 involved a
multi-million dollar campaign, the funding for the campaign came
primarily from individuals who had a family member who suffered from
a chronic disease or injury, including individuals associated with a
venture capital firm. The firm itself did not contribute to the
campaign, nor did the campaign accept contributions from
biotechnology or pharmaceutical companies. Furthermore, the venture
capital firm did not invest in a CIRM grantee; rather, it invested in
a different company which subsequently merged with yet another
company to form an entity that later applied for, and was awarded a
CIRM grant.
Cells, Inc.
Jensen cites CIRM’s award to Stem Cells, Inc. as another source of
a conflict. In support of this claim, Mr. Jensen’s references Bob
Klein’s support of the award, as well as the fact that Irv
Weissman, PhD, appeared in an ad for Proposition 71 in 2004.
However, neither Mr. Klein’s support for the award nor Dr.
Weissman’s support for Proposition 71 constitutes a conflict of
interest. First, Mr. Klein, like any member of the public, has the
right to express his views to the Board. The state’s revolving
door laws do not apply to a former member of the Board who, like Mr.
Klein, is not compensated for making an appearance. As for Dr.
Weissman’s support for Proposition 71, nothing in state law
prohibits a member of the public from seeking CIRM funding even
though he supported the measure during the campaign. In fact, it
would be reasonable to expect that most stem cell scientists in
California (and elsewhere) supported Proposition 71. Disqualifying
individuals from receiving funding because they supported the law
would leave few, if any, eligible applicants.
of Conflict at Board Meeting
further evidence of an “actual conflict”, Mr. Jensen cites
another instance in 2008 in which a representative of a for-profit
applicant publicly complained at a Board meeting that a member of the
GWG had a conflict of interest “from a business perspective.” As
provided for by CIRM’s regulations, the applicant had filed an
appeal, claiming that the reviewer had a conflict of interest because
he had a financial relationship with another company that was not an
applicant for CIRM funding. CIRM’s legal counsel reviewed the
appeal and determined that there was no conflict of interest under
CIRM’s policy.
Ramasastry and Laurence Elias
Jensen cites two instances in which CIRM’s hired consultants in
support of his claim that CIRM has “actual conflicts of interest.”
In 2010, CIRM retained a partner at Life Sciences Advisory, LLC,
Saira Ramasastry, to assist CIRM’s External Advisory Panel, which
completed its work in December 2010. In 2012, Sangamo BioSciences,
Inc., nominated Ms. Ramasastry to serve on its Board of Directors.
Although Ms. Ramasastry continued to provide some consulting services
to CIRM through fiscal year 2011-12, none of her work for CIRM
involved Sangamo or any CIRM program in which it was involved. Ms.
Ramasastry’s services on behalf of CIRM did not create any conflict
of interest. The same is true of the second instance cited by Mr.
Jensen. In 2010, CIRM hired Dr. Laurence Elias, a former Geron
employee and an accomplished clinical development professional, to
provide CIRM with technical and regulatory input to ensure that the
clinical elements of an RFA were technically complete and accurate.
The concept for RFA had already been approved and as such Dr. Elias
was not in any position to influence the overall scope or structure,
nor did he have any role in evaluating applications. CIRM staff and
Dr. Elias complied with all conflict of interest requirements.
Neither contract led to an “actual conflict of interest”.
Winokur
Jensen’s laundry list of “conflicts” also includes a reference
to the recent appointment of Diane Winokur to serve on CIRM’s
Board. Mr. Jensen quotes a representative of the ALS Association who
said that Ms. Winokur will be “a tremendous asset in moving the ALS
research field forward through CIRM funding." Of all the
insinuations made in his blog this is perhaps the cheapest shot,
taking aim at a woman who has dedicated her life to fighting a deadly
disease, one that claimed the lives of her two sons. Mr. Jensen knows
very well that the ALS Association does not speak for Ms. Winokur or
CIRM and while we expect that Ms. Winokur will bring her expertise as
an advocate for people suffering from ALS to the Board, she, like all
members of CIRM’s Board, represents all Californians, not just
those suffering from a particular disease. Ms. Winokur’s
appointment does not create a conflict of interest.
Releases
Mr. Jensen cites a Board debate from 2006 involving a requirement in
CIRM’s intellectual property regulations regarding press releases.
Under Health and Safety Code section 125290.30(g)(1)(C), the
discussion of standards does not create a conflict of interest, and
the Board’s debate was enriched by the participation of members who
brought their expertise and experience to bear.
Jensen says that one of the reasons why the IOM did not report any
instances of conflict of interest in its report is that it did not
look for any conflicts of “inappropriate behavior,” But Mr.
Jensen was present in the public hearing at UC Irvine in April of
2012 when the IOM panel asked Stuart Drown, Executive Director of the
Little Hoover Commission that also looked into allegations of
conflict of interest at CIRM, if he could cite any actual instances.
Mr. Drown said he could not. Nor did Mr. Jensen offer any when it was
his turn to talk.
The view from the California Stem Cell Report:
speaking, CIRM's response about “actual” conflicts of interests
is a reiteration of what the California Stem Cell Report carried at
the time of each incident and does not add much new to the discussion
of the issues. All of the agency's earlier responses could be found in
the links in the “debunking” piece. Additionally the agency
confuses what are clearly actual conflicts with other instances that
could involve either actual or perceived conflicts, which the IOM
noted can be as deadly as the real thing. However,
in the most egregious cases involving Reed and later the five medical
school deans, the agency would like the public to believe that these
were not serious matters because the staff detected and caught the
conflicts before the grants were made.
is like saying a burglar who was caught in the act before he escaped
with his booty committed no offense.
acts were committed by members of the CIRM board, and they were
violations of conflict of interest standards. In the case of
the five deans, that is why the agency voided 10 applications
totaling $31 million from their five institutions. If there had been
no actual conflict of interest, that would not have been necessary.
for blaming the staff for “miscommunications,” the applications
that the five deans signed were quite clear and offered them the
option of having another person at their institution sign the grant
proposal. Other deans on the board did not sign applications in the
same round. Those applications were then handled in the normal
fashion. One might ask how in the world could the head of a medical
school who was also serving on the CIRM board NOT recognize a
conflict of interest when asked to sign a request for cash from the
board on which he served?
John Reed and his conflict of interest violation, both he and then
CIRM Chairman Robert Klein have acknowledged Reed's actions
were wrong. Klein, an attorney who directed the writing of the
10,000-word measure that created CIRM, advised Reed to contact CIRM
staff to lobby on behalf of a grant that was approved by the board
but was about to be denied by staff.(See here, here and here.)
response contends that Reed's 6 ½ page letter was nothing more than
“factual” information dealing with technical matters. That is
hardly the case. In fact, Reed explicitly “emphasized” (Reed's word) that failing to comply with his letter would damage the future
of the stem cell agency. Denial of the grant, he said, “will surely
discourage clinical researchers from participating in the CIRM
mission to advance stem cell therapies.”
action was inappropriate, and the California Fair Political
Practices Commission warned Reed about his actions. The journal Nature reported,
“California’s
Fair Political Practices Commission (FPCC) decided that Burnham
Institute President violated conflict-of-interest rules by writing a
letter to the California Institute of Regenerative Medicine appealing
a decision that an affiliate of his institute was ineligible for
funding.”
California Stem Cell Report's “debunking” piece went beyond "actual" conflicts to describe other instances where conflicts emerged.
Readers can go back to the original links for all the details, but
the cases of StemCells, Inc., and iPierian, Inc., are worth reviewing
again. Both cases involve fund-raising efforts that ran into
millions of dollars for the ballot measure campaign that created
CIRM. The campaign was run by Bob Klein who later became the agency's
first chairman, serving for six years and becoming something of a
hallowed figure in stem cell circles. One of the principal jobs of a
campaign manager is to raise the millions needed to run a successful
statewide election campaign in California. It is common for members
of the public to believe that major campaign contributors are
rewarded later for their contributions. Whether that was the case in
these instances, the reader must decide for himself or herself. But
the appearance is less than salubrious for an agency that claims to
have never seen an actual conflict of interest as it has handed out
$32,000 an hour, 24 hours a day, seven days a week during the last six
years.
facts are that about 90 percent of the $1.7 billion awarded by the
CIRM board has gone to institutions tied to present and past members
of its governing board. The agency, however, does work hard to be
sure legal conflicts do not arise during board action on grant
applications, using a voting procedure that is so convoluted that the
actual vote on nearly all applications is not even announced at board
meetings. Sometimes the procedure means that only a handful of
governing board members can participate in debate or vote. In the
case of the five medical school deans, as the board struggled to deal
with the fallout in 2007, only eight of the 29 members of the board could participate in the discussion because the rest had conflicts.
for CIRM's comments about “insinuations” and “cheap shots” by
the California Stem Cell Report, we naturally differ with that
characterization. The case in point involved what the chief scientist
for a patient advocate group said she expected as the result of a
recent appointment to the board. The scientist's remarks were offered
as example of the type of expectation and entitlement that can arise when governing
board members must be picked from specific constituencies, as is the
case with all 29 CIRM board members.
And as for my testimony at the IOM hearing last April, here is a link to my statement, which includes a discussion of conflicts of interest.
Source:Stem Cell Therapy
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February 17th, 2013
CIRM Board Member Prieto Critiques the IOM Stem Cell Report
By Dr. Matthew Watson
Francisco Prieto, a member of the
governing board of the $3 billion California stem cell agency, is
expressing some additional dissatisfaction with the blue-ribbon
Institute of Medicine (IOM) report for which the agency paid $700,000.
at the agency, including creation of a new majority of independent
members on the board. The IOM cited problems arising from the
built-in conflicts of interest on the board that were created by
Proposition 71, which created in the agency in 2004. Prieto's email refers to Bob Klein, who is a real estate investor and attorney. Klein
oversaw the drafting of the 10,000-word ballot measure(writing much
of it himself), ran its $35 million ballot campaign and became the
first chairman of the agency. The qualifications for chairman were written into the proposition and seemed to uniquely apply to Klein. Prieto is a Sacramento physician who
was appointed to the board as patient advocate.
His earlier comments can be found here.
“A few more words on independence,
and the IOM. I think Bob Klein drafted the proposition (and
remember, all of this was spelled out there – readily available to
the voters and whatever news sources they were depending on for
information) deliberately to engage patient advocates. I think he
knew that those of us who have been active in disease advocacy have a
passion around the issue of advancing research that someone without
that background would be unlikely to have. I’m not sure exactly
what the IOM had in mind when they called for more 'independent'
members of the board, since they very unfortunately did not bother to
interview the patient advocates on the ICOC(the governing board). I
don’t know what their reason for this was, if there was one, but
they only circulated a (in my view) frankly inadequate questionnaire,
and interviewed a small handful of people. I think this was a major
flaw in their process and gave them a very limited view of our role.
It is hard for me to imagine who they might have in mind, if not
people who had been involved with some existing advocacy
organization. I think there are very few if any patient advocates who
aren’t working with some group – the only ones I might imagine
would be some independently wealthy person able to start a foundation
or research institute on their own. With all due respect to
Bill Gates and the great work his foundation is doing with malaria
and HIV, I have written before that I think it would be absolutely
wrong and anti-democratic to create any public board or commission
that only millionaires could sit on.”
concerning the IOM report and conflicts of interest. It dealt briefly
with the issue and difficulty of managing conflicts. The comment can be found at the end of this item.
Source:Stem Cell Therapy
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February 17th, 2013
Riverside Newspaper: ‘Ethical Minefield’ Still Not Cleared at Stem Cell Agency
By Dr. Matthew Watson
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.
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.
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.
“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 Therapy
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February 10th, 2013
Stem Cell Agency Board Member Defends Independence of Many on Board
By Dr. Matthew Watson
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.
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.'”
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.
agency in 2004, was carefully crafted to avoid the use of the word
“independent” when describing the necessary qualifications for a
board member.
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.”
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:Stem Cell Therapy
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February 10th, 2013
Debunking California Stem Cell Agency Claims of ‘No Actual Conflicts’
By Dr. Matthew Watson
In the wake of recent considerable
criticism concerning conflicts of interest at the $3 billion California stem
cell agency, its leaders have taken to saying “no actual conflicts”
have been found at the agency.
repeated in some news stories, published in at least one agency press
release and peddled by stem cell advocates and some members of the
governing board of the California Institute for Regenerative Medicine
(CIRM), as the agency is formally known.
cited prominently as a major problem at CIRM by the blue-ribbon
Institute of Medicine (IOM) report. In December, the IOM recommended that a new majority of independent members be created on the stem
cell agency's governing board. The existing stem cell board has
ignored that recommendation and wants to settle for something considerably less as it tries to find a way to build support for
continued financing of its efforts.
long history of problems involving conflicts of interest, “actual”
and otherwise. Here is a rundown on what has been reported on the
California Stem Cell Report.
CEO of the Sanford-Burnham Institute, was warned by the state's Fair Political Practices Commission about his violation of conflict of interest rules. Reed's intervention on behalf of a grant was made at the suggestion of then CIRM Chairman Robert Klein, an attorney who
led the drafting of Proposition 71, the ballot initiative that created the stem cell
agency in 2004.
researchers seeking $31 million. And then the agency shamefully scapegoated employees for the problem.
violation, which the agency felt necessary to report to the
California legislature.
who has deep connections to the biomedical industry, served as the
agency's interim chief scientific officer and helped to develop the agency's first, signature $225 million disease team round while also
serving on the CIRM board. As chief scientific officer, Love
presumably would have had access to proprietary information and trade
secrets contained in grant applications. In 2009, in response to
questions from the California Stem Cell Report, the agency said that Love would only serve as a part-time adviser to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board
passed a resolution with high praise for Love and his performance as the chief scientific officer.
million in awards from the agency. The contributions were 25 percent
of the total in the campaign, which was headed by Klein.
fall was awarded $40 million by the CIRM board despite having one of
its $20 million applications rejected twice by grant reviewers. The
action came after the board was vigorously lobbied by former Chairman
Klein. Researcher Irv Weissman of Stanford, who founded StemCells, Inc., and
is on its board, was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the ballot campaign.
applicant from industry about conflicts of interest on the part of a
reviewer were brushed off by Klein. He told the applicant the board needed to discuss naming CIRM-funded labs and then go to lunch.
industry consultants in positions that raise conflict of interest
problems, in 2010 and again in 2012.
increased funding as the result of the appointment of sympathetic
individuals to the board. That occurred last fall when Diane Winokur
was appointed. The chief scientist for The ALS Association, said
Winokur will be “a tremendous asset in moving the ALS research field forward through CIRM funding."
considerable time debating a minor requirement involving press
releases. They were concerned that the proposal would make their
institutions subordinate to the interests of CIRM. At the end of the
discussion, the institutional directors prevailed and kept their PR
departments from having to notify CIRM about press releases dealing
with the hundreds of millions of dollars in state grants that they
receive.
CIRM Chairman Jonathan Thomas was quoted in a CIRM press release as
saying “no one has found any actual conflicts” at the
agency.
stories have reported that the IOM did not find any “actual”
conflicts at the agency. The explanation for that is simple, but
mainly omitted from the articles. The IOM did not look for any
conflicts of “inappropriate behavior,” as its report clearly
states. The California Stem Cell Report last weekend asked the
chairman of the IOM panel, Harold Shapiro, why it did not look for
conflicts. He replied,
“Our committee was given a set of
defined tasks from the IOM(which was under a $700,000 contract with
CIRM), and we followed them."
too many” board members are linked to institutions that receive
funds from CIRM. A compilation by the California Stem Cell Report
shows that about 90 percent of the $1.7 billion that the board has
awarded has gone to institutions linked to past and present board
members.
the CIRM board is that nearly all the California institutions that stood to
benefit from the agency's largess were given seats at the table where the
money is handed out, under the terms of Proposition 71.
CIRM and government agencies. They are also a matter of concern at
nonprofit, grant-making foundations, which in some ways CIRM
resembles.
national nonprofit association of more than 1,700 grant-making
organizations, takes pains on its web site to explain the
importance of managing and avoiding conflicts of interests. In its advice to its members, the group makes it clear that the issue goes
well beyond simple financial conflicts. It says,
“(Board) members must represent
unconflicted loyalty to the interest of the foundation. This
accountability supersedes any conflicting loyalty such as that to
advocacy or interest groups, business interests, personal interests or paid or volunteer service
to other organizations.”
the “unconflicted loyalty” is to the people of California. Perhaps the California stem cell agency
can convince state leaders, both public and private, and its voters
that no conflicts exist at the state agency. But it is a big bet and
probably carries with it the entire future of what the board and many
believe is an exceedingly promising scientific effort.
to step back and say, “Yes, there are serious conflict problems at
CIRM. We recognize that and are working on additional measures to
create an independent board as recommended by the IOM.”
Source:Stem Cell Therapy
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February 10th, 2013
Hyping the Economic Impact of the California Stem Cell Agency
By Dr. Matthew Watson
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.
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.”
original study but contends the report is “independent” of CIRM.
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.
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."
“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.”
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.
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.
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:Stem Cell Therapy
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February 3rd, 2013
Sacramento Bee: Stem Cell Agency Falling Short on IOM Recommendations
By Dr. Matthew Watson
It's exceedingly rare when the
California stem cell agency makes the front page of any newspaper.
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.
“Analyst: Stem
cell agency reforms fall short.”
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.
Shapiro said the stem cell agency is “falling short” in its
response to the IOM recommendation.
"'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.'"
board that has been plagued by the appearance of conflicts of
interest, cronyism and sluggishness in getting stem-cell products to
market.”
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.”
“The process would take years, he
said. The first opportunity to get on the ballot, for instance, would
be in the fall of 2014.”
grants in less than four years.
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:Stem Cell Therapy
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February 3rd, 2013