1. Stem Cell Therapy

Category Archives: Stem Cell Therapy

Meager California Biotech Representation in Governor's China Trip

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California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.
According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)
California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.
A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..
We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html

More about Funding for Personalized Medicine Research

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A post entitled Funding for Personalized Medicine Research, dated January 31, 2012, provided information about the participation of the Cancer Stem Cell Consortium (CSCC) in the Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR).

On March 26, 2013, it was announced that 17 projects will be supported. A list of these project is available (PDF). One of the 17 projects is entitled "Innovative chemogenomic tools to improve outcome in acute myeloid leukemia". The Project leader is Guy Sauvageau of the Institute for Research in Immunology and Cancer (IRIC) at the Université de Montréal. The Project co-leader is Josée Hébert of the Centre de Recherche Hôpital Maisonneuve-Rosemont, Montréal. One of the aims of this project is to develop new models for tracking cancer stem cells that are left behind after a patient is treated.

Source:
http://cancerstemcellnews.blogspot.com/2013/03/more-about-funding-for-personalized.html

StemCells, Inc., Rejects $20 Million from California Stem Cell Agency

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When does a financially struggling
biotech company turn down a $20 million “forgivable loan?”

When it is StemCells, Inc., of Newark,
Ca., and the cash is being offered by the $3 billion California stem
cell agency. The research program has handed out nearly 600 awards, and it is the first time that a recipient has rejected funding.
That's the latest development in a stem
cell saga that began publicly last July and that involved unusual personal lobbying by the former chairman of the Golden State's stem cell research agency. The high point of the saga may have come in
September when the agency's governing board finished awarding
StemCells, Inc., $40 million in two different awards. But there was a
catch. StemCells Inc., had to match that figure with $40 million of
its own.
Late last month, StemCells, Inc., threw
in the towel on the $20 million awarded on its cervical spinal cord
injury application. In comments to analysts March 21, Rodney Young,
chief financial officer of the publicly traded company, said:

“The funding would have been in the
form of a forgivable loan, however, we have elected not to borrow
these funds from CIRM(the stem cell agency).”

According to the Seeking Alpha transcript of the conference call with analysts, Young said,

“You may also recall that last
September, CIRM approved a separate application under the same
disease team program for Alzheimer's disease, which was also for up
to $20 million in the form of a loan. We remain in confidential
negotiations with CIRM regarding the terms and conditions that would
attach to this loan.”

The company provided no explanation for
rejecting the cash, either in the conference call transcript or in
its press release.
During the conference call, StemCells,
Inc., reported continuing losses. For 2012, net losses totaled $28.5
million compared to $21.3 million in 2011. Revenue for 2012 was $1.4
million compared to $1.2 million in the previous year.
The awards last year to StemCells,
Inc., founded by Stanford's eminent researcher Irv Weissman, stirred
up a bit of a ruckus. The spinal injury award was handed out
routinely in July. Scientific reviewers gave it a score of 79 and
recommended funding. It was another matter on the Alzheimer's
application. It was scored at 61. Reviewers said it did not merit
funding. But the company publicly appealed to the full board, which sent the
application back for more examination. It was rejected again.
Nonetheless, in September, the 29-member board approved the award on
a 7-5 vote, bypassing a rival Alzheimer's application scored at 63.
It was the first time in the eight-year-history of the agency that
its board approved an application that was rejected twice by
reviewers.
Approval came only after strong
lobbying by Robert Klein, former chairman of the board. Klein was
also chairman of the ballot campaign that created the agency, and
Weissman, who holds stock in StemCells, Inc., and sits on its board,
was a major fundraiser for the campaign. 
The Los Angeles Times' Pulitzer
Prize-winning columnist, Michael Hiltzik, wrote in October that
 the process was “redolent of cronyism.” He said a
“charmed relationship” existed among StemCells, Inc., its
“powerful friends” and the stem cell agency.
As for the remaining $20 million award,
Martin McGlynn, CEO of StemCells, Inc., expects “quick” action on
finally securing the cash.
Here is an exchange that came during
the March conference call between McGlynn and analyst Kaey Nakae of
Ascendiant Capital Markets.

Nakae: “Okay. Just 2 more questions.
I guess the first one, as it relates to CIRM.
In deciding to decline the funding for spinal cord yet continuing to
pursue the funding for Alzheimer's, is there a difference in what
you're getting from them in terms of potential terms and conditions
that allow you to proceed on one and not the other, or is it the fact
that you're already in human with -- in spine, and still very
preclinical with Alzheimer's?”

McGlynn: :”I think you're very
definitely -- you're getting at some important criteria when one
considers how to fund programs whether you use debt or equity,
etcetera. So I wouldn't disagree with anything that you've outlined
or surmised. But I just would pray your indulgence until we're
finished, the negotiations with CIRM, which are coming to a close and
we expect those to resolve pretty quickly with regards to the
Alzheimer's program. And then quite frankly, we can be way more
forthcoming and way more disclosive with regards not only to our
decisions, but to our thinking.”

StemCells, Inc., was trading at about $1.65 at the time of this writing, down slightly from the previous
day. Its 52-week high is $2.67 and its 52-week low $0.59.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zYvykN1XE6k/stemcells-inc-rejects-20-million-from.html

Modest Approval from Long-time Stem Cell Agency Critic

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Of all California's newspapers, The
Sacramento Bee, the only daily paper in the state capital, has long
been the most critical – editorially – of the Golden State's $3
billion stem cell research agency.

Today, however, the newspaper gave a
modest nod of approval to the agency's modest efforts to clean up its
built-in conflicts of interest, which have been cited as a major flaw
by the prestigious Institute of Medicine.
The headline on the Bee's editorial today said,

“Stem cell agency finally addresses
potential for conflicts”

The piece said that Jonathan Thomas,
chairman of the agency, “has taken important steps in
reducing the potential for conflicts within this agency.”
The editorial continued,

 “He hasn't
gone as far as we would like, or that independent outside reviewers
have recommended....But he's achieved what's possible, at least for
now, and the board may empower him to go further.”

The Bee referred to action last month
in which the agency's governing board decided, among other things,
that 13 of the 15 board members linked to recipient institutions
could not vote on any grants, although they could participate in
discussion of applications. Twenty-nine persons sit on the board. In
a $700,000 report commissioned by the agency, the Institute of
Medicine recommended a fully independent board.
The Sacramento newspaper said, 

“We
think Thomas and the oversight board should go further and adopt the
Institute of Medicine recommendations. But that is politically
unlikely. As is now obvious, it will be up to the Legislature to
fully remove representatives of funding-eligible institutions from
being involved in decisions about grants that could come back to
them.

“Thomas, to his credit, recognizes
that his compromise may not be the perfect solution. He wants to test
out the new policy for a year, and see how it works. There's a lot
riding on the outcome. CIRM is expected to run out of funds in 2017,
and while philanthropy and foundation money could extend that for a
few years, supporters of California stem cell research clearly want
to go back to the ballot to seek additional funding. To make that
case, CIRM supporters can't afford any more scandals about insider
dealing. The next year will reveal whether it is on the right track.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/NowG2d8N5CM/modest-approval-from-long-time-stem.html

California Stem Cell Directors to Finalize IOM Response Next Week

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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.

CIRM Chairman J.T. Thomas last week
told the San Diego U-T editorial board that he regarded approval as
“largely ministerial.”
Thomas has been visiting newspaper
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.
About 90 percent of the $1.8 billion
that has been awarded by the CIRM board has gone to institutions
linked to past and present members of the board.
In December, the Institute of Medicine cited major
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.
An analysis in January by the
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.
Also on the agenda for the March 19 is
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.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FH7dzoNWS8c/california-stem-cell-directors-to.html

Cyberspace Makeover at California Stem Cell Agency

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California's $3 billion stem cell
agency has performed a well-done makeover on its most important
public face – its web site, which is chock-a-block full of useful
information for researchers and the unwashed alike.

At cirm.ca.gov, one can find the very
words of its directors as they wrestle with everything from grant
approvals to conflicts of interest. Scientists can be seen telling
the story of their accomplishments. Money can be followed, and
summaries of reviews of grant applications read, both those approved
and those that did not pass muster.
The web site of the California
Institute of Regenerative Medicine (the formal name of the agency) is the place where the stem cell program
really meets the public. News stories are important, but infrequent.
Day to day, however, thousands of interested persons seek out
information that the folks at CIRM HQ, just a long throw from the San
Francisco Giants ballpark, bring to cyberspace.
Each month, said Amy Adams, major domo
of the web site, 15,000 to 17,000 “unique viewers”
visit online. She told the California Stem Cell
Report in an email,

“We're up about 25 percent year over
year in unique viewers to the site. A lot of that growth comes from
search, and the rest is from traffic driven through our blog and
Facebook.” 

The numbers are not huge compared to
those chalked up by major media sites. But they are significant
given that there are only a few thousand people worldwide who are
deeply and regularly interested in stem cell research. Many more,
however, are stimulated to look into the subject from time to time,
either because of news stories, personal, disease-related concerns or simple interest in cutting edge science. Engaging those
readers, who can spread the CIRM story, and winning their approval is
critical for the agency as it faces the need to raise more millions
as it money runs out in the next few years.
CIRM has mounted much information online over
its short life. So much that good tools are needed to navigate the
site. Decisions about what should go on the home page are critical.
With the makeover, the agency now has a long-needed, home-page link to its
meetings , especially those of its governing board, which are the
single most important events at the agency.
The redesign is crisp and clean. The
new, white background makes it easier to read and is comfortable for
readers long conditioned to the black-on-white print of the books,
newspapers and magazines. The video image on the home page is larger,
which helps attract viewers. The site has long had a carload of
videos, some of which contain powerful and emotional stories from
patients.
Adams used CIRM staffers to test the
new features. She reported,

“I've had people inside CIRM (who
have been beta testing this site) tell me that they are finding
content they'd never seen before because the site is so much easier
to navigate.”

Adams and the CIRM communications team
also have pulled together important information on each grant on a
single page, including progress reports. You can find a sample here on a $1 million grant to Stanford's Helen Blau.
Adams said,

 “Now people can not only
read about what our grantees are hoping to accomplish, they can read
about what has actually been accomplished with our funding.”

Adams said another new feature is
downloadable spread sheets of information that can be manipulated by
readers offline. She said,

“Most places on the site where you
see tables, you can now download those tables to Excel. You'll notice
the small Excel icon at the lower left of the table. This feature has
long been available for the searchable grants table. Now you'll see
it on all the tables of review reports (see here for
example http://www.cirm.ca.gov/application-reviews/10877)
on the disease fact sheets (see
here http://www.cirm.ca.gov/about-stem-cells/alzheimers-disease-fact-sheet)
and other places throughout the site. This is part of an effort to
make our funding records more publicly available.”

CIRM's search engine for its web site
still needs work. A search using the term “CIRM budget 2012-2013”
did not produce a budget document on the first two pages of the
search results. A search on the term “Proposition 71,” the ballot
initiative that created CIRM, did not provide a direct link to its
text on the first two pages of search results.
Also missing from the web site, as far
as I can tell, is a list of the persons who appointed the past and
present board members as well as the dates of the board members'
terms of office. The biographies on some of the 29 governing board
members come up short. In the case of Susan Bryant, her bio does not
mention that she is interim executive vice chancellor and provost at
UC Irvine. Links also could be added to board members statements of economic interest. A list of CIRM staff members (only slightly more than 50
persons) and their titles could be added.
As for CIRM's count of visitors, CIRM
uses Google Analytics tools. Adams said,

“A unique visitor is Google's
definition (it's one of the metrics they provide). It's a visit from
a unique IP (internet protocol) address. So, if you visit our site
multiple times from one IP address during a day, you count as a
single unique visitor. (Editor's note: It is possible to have
more than one visitor from the same IP address.)

“We get ~23,000-25,000 visits per
month, or ~16,000-18,000 unique visitors. Page views are on the order
of 65,000 a month.”

Our take: The redesign of the web site
is a worthy effort and enhances CIRM's relationships with all those
who come looking for information. The agency is to be commended and
should continue its work to improve the site and its connections with
the public.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1OuvEMC2aTs/cyberspace-makeover-at-california-stem.html

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

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“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

San Diego Newspaper Hails Stem Cell Agency and IOM Response

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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.”

The San Diego U-T, the largest
circulation newspaper in the area, said the big headline about the
eight-year-old agency is “the potential for transformative medical
breakthroughs.”
The editorial noted that the agency has
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.
But the agency “is finally taking the
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.
The stem cell business is no small
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.
The newspaper's editorial said,

“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.”

The editorial followed a meeting
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.
The newspaper's biotech reporter,
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/WHLDfisWzQI/san-diego-newspaper-hails-stem-cell.html

Good News, Bad News and the California Stem Cell Agency

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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

CIRM Director Prieto on Disclosure of Reviewer Financial Interests

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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

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

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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

City of Hope Exec Will Leave California Stem Cell Agency Board

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Michael Friedman
City of Hope photo
The governing board of the $3 billion
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.
He will join Claire Pomeroy in leaving
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.
Both have been on the CIRM board since
its first meeting in December 2004. Pomeroy was appointed by the UC
Davis chancellor. Friedman was appointed by the state treasurer.
No names have surfaced concerning
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.
To fill Friedman's seat, Treasurer Bill
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.
Both UC Davis and the City of Hope have
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.
A blue-ribbon report by the Institute
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.
According to compilations by the
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.
The agency has $700 million remaining
before money for new awards runs out in less than four years.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DWx8xx07ZOY/city-of-hope-exec-will-leave-california.html

California Stem Cell Agency Bonds On Sale in March

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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

California Stem Cell Agency: Comparing the Critiques

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

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

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

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

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

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

“California
must get its stem cell house in order”

The editorial continued:

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

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

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

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

Monitoring the Cash and IP at the California Stem Cell Agency

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

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

“Because CIRM is a new institution
without a track record to reassure stakeholders, and because its
finite funding timeline means as yet unknown agencies will be
enforcing these policies years down the road, CIRM should “propose
regulations that specify who will have the power and authority to
assert and enforce in the future rights retained by the state” in
CIRM IP, specifically referring to march-in rights, access plans and
revenue sharing....

“Second, as other sources of funding
become more prevalent, the agency should “reconsider whether its
goal of developing cures would be better served by harmonizing CIRM’s
IP policies wherever possible with the more familiar policies of the
BayhDole Act.”

Here are the CIRM staff
recommendations.

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

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

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

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

San Jose Newspaper Lauds CIRM Chairman Thomas

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CIRM Board Member Prieto Critiques the IOM Stem Cell Report

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

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

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

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

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


  1. Stem Cell Therapy