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Category Archives: Stem Cells

Public Banned from 'Best Stem Cell Meeting in the World'

“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.

More than 500 persons are at the meeting at an undisclosed location, including some
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.”
CIRM President Alan Trounson addressed
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.
The attendees consist almost entirely
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.”

Kevin McCormack, spokesman for the
agency, today said the public was barred from the meeting, which ends tomorrow, because “so
many presentations/talks (are) using proprietary information.”
That rationale is nothing new in the
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.
Yesterday we wrote briefly about the importance of transparency and openness in government, and make no mistake about
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.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uiwodYaNIP8/public-banned-from-best-stem-cell.html

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Good News, Bad News and the California Stem Cell Agency

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.

The comment was thoughtful and pointed
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.)
Given the reader's remarks, it seems a
good time to review the operating principles and biases of the
California Stem Cell Report.
Bias No. 1: Openness and transparency
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. 
Regarding our operating principles, the
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.
The California Stem Cell Report also
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.
Analysis and explanation of what the stem cell agency does is rare in the California media and even less seen
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.
Then there is the funding of the
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.
Since January 2005, we have posted
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.
We do not attempt to replicate what the
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.
The California Stem Cell Report also
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.
Finally, given the questions raised by
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GRJeamu0RXw/good-news-bad-news-and-california-stem.html

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LA Times: Stem Cell Agency Conflict-of-Interest Response Only a Bandage

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.

But the newspaper, which has the largest circulation in the state, said that was more was
needed if the agency plans to have a life after 2017, when funds for
new awards run out.
The Times editorial said,

“After years of resisting all
criticisms of its operations, the California Institute for
Regenerative Medicine is finally listening — a little.“

The editorial continued,

“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.”

The board plans to have 13 board
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.
The Times said December's blue-ribbon
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.
The editorial concluded,

“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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4TPMCEI6hDg/la-times-stem-cell-agency-conflict-of.html

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CIRM Director Prieto on Disclosure of Reviewer Financial Interests

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.

Francisco Prieto, a Sacramento
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.”

Our take: Prieto is right about the
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.
Proposition 71 placed the legal
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.
Yet, if the board concedes the
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.
The issues involving disclosure by
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
However, it makes little difference
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.
The trend in the academic and
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.
Our thanks to Prieto for his comments
on this important subject.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/OlA8vhJTIsA/cirm-director-prieto-on-disclosure-of.html

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California Stem Cell Agency: Comparing the Critiques

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

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

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

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California Stem Cell Agency Bonds On Sale in March

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.

It is all part of an arrangement that
currently involves short-term borrowing as well to keep the cash
pipeline at CIRM properly filled.
To refresh some of you, the agency
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.
The California Stem Cell Report last
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.”

Proposition 71, which created the stem
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GGDUJVY45VQ/california-stem-cell-agency-bonds-on.html

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