‘Paradigm Shift’ — Researchers as Patient Advocates?

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It is not easy for a stem cell
scientist to break into “print” in that bastion of American
capitalism, Forbes magazine. Much less one from that perceived
antithesis of free enterprise, Reed College.
But researcher Paul Knoepfler of UC
Davis has done just that.
John Farrell of Forbes wrote about Knoepfler on
Friday in the wake of the announcement Knoepfler will be honored with
a “national advocacy” award by the Genetics Policy Institute.
Paul Knoepfler -- Advocate for a "new ethos"
UC Davis photo
Knoepfler, who received a degree in
English literature from Reed in 1989, is being recognized for his
activities as a stem cell blogger since 2009.
Farrell quoted Knoepfler as saying in
an email,

“With many stumbles, face plants,
land mines, and even a few threats of litigation and career
retaliation along the way for the last three and half a years, I
turned my crazy idea into a reality.”

Farrell continued,

“But it was only possible,
(Knoepfler) added, with guidance from many patient advocates and
bloggers in other fields who generously helped him learn the ropes of
blogging.

“'I see this award as a validation of
the notion that advocacy by scientists has become a valued part of
the stem cell field,' he said.

“'My hope is to catalyze a continuing
paradigm shift whereby stem cell scientists and biomedical scientists
more generally have a new ethos that not just accepts, but also
deeply values advocacy.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tuEB7SGOuMQ/paradigm-shift-researchers-as-patient.html

Coming Up: Live Coverage of Today’s California Stem Cell Meeting

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The California Stem Cell Report will
provide live, wall-to-wall coverage of today's meeting of the
governing board of the $3 billion California stem cell agency.
At the top of the agenda is a $70
million proposal aimed at creating a string of Alpha stem cell clinics in
California that would serve as a foundation for the state's stem cell
business. Also on tap are other proposed grant programs, including a
$23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into
cures.
Stories will be filed as warranted
throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in
on the meeting via the Internet. Instructions can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Vi8IGlL2TzY/coming-up-live-coverage-of-todays.html

CIRM’s Roth Dies Following Bike Accident

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Duane Roth, co-vice chairman of the
California stem cell agency, died yesterday from brain injuries
suffered in a bicycle accident two weeks ago.
Duane Roth, Connect photo

Roth, CEO of Connect, a San Diego
organization aimed at fostering technology entrepreneurship,
succumbed yesterday afternoon at the UC San Diego Medical Center, the
San Diego U-T reported. He was 63.
An avid bicyclist, Roth was injured
while biking in the mountains east of San Diego July 21. Roth hit an
outcropping and his helmet was broken in the accident.
Roth was a long-time member of the
29-person governing board of the $3 billion California stem cell
agency and was a strong advocate for industry. He chaired the
agency's loan task force, was vice chair of the Intellectual Property
and Industry Engagement Subcommittee and a member of the executive
committee.
J.T. Thomas, chairman of the stem cell
agency, released the following statement this morning.

“On behalf of all the CIRM family, we
mourn the loss of our colleague and dear friend Duane Roth. 
Throughout his tenure with us, he was one of the true stewards of the
mission, offering countless insights on the role of industry in the
world of regenerative medicine and how best and efficiently to drive
therapies through to patients.  He was unfailingly a voice of
reason and optimism and always sought to find ways to make things
happen, refusing to take 'no' for an answer.  Though one of 29
Board members, his extensive participation as co-Vice Chair of the
Board, co-chair of Intellectual Property and Industry Engagement
Subcommittee and a member of our Executive Committee gave Duane a
singularly important and resonant voice in our organization. 
His passing will be deeply felt by all of us as well as by the many
patients and other CIRM stakeholders whom he touched over the years. 
We send our deepest sympathies to Renee, Duane's brothers and the
rest of the Roth family.”

Roth recently was involved in raising
funds for cancer, and reporter Bradley Fikes wrote in the San Diego
U-T,

“Contributions in Roth’s name can
be made to Pedal
the Cause, a fund-raiser for cancer research that Roth supported.
More than $10,000 has been raised since Roth's accident."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/58gRzPR09kU/cirms-roth-dies-following-bike-accident.html

Riverside Newspaper: ‘Ethical Minefield’ Still Not Cleared at Stem Cell Agency

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The California stem cell agency's
attempts to deal with the conflict of interest problems at the $3
billion research program amount to a minor fix that is not a “serious solution,” the Riverside Press-Enterprise editorialized yesterday.

The editorial came as the agency
launches a road trip campaign to convince newspaper editorial boards around
the state that the agency is worthy of continued financial support.
The agency will run out of money for new grants in less than four
years.
The Riverside editorial pointed to the blue-ribbon Institute of Medicine report in December that called for creation of a
new, independent majority on the 29-member board. None of the current
members are independent. The ballot measure that created the
agency required board members to be appointed from various
constituencies.
The newspaper said,

“That arrangement is hardly a model
of objective decision making. The agency so far has distributed about
$1.7 billion in grants, with about 90 percent of that money going to
institutions represented on the governing board. 

“Voluntary abstentions are not a
serious solution to that ethical minefield. Nor would that approach
eliminate potential conflicts, because the agency would still allow
the abstaining members to take part in the discussions and debate
about who should get the grants. 

“The Institute of Medicine instead
recommended remaking the board with truly independent members who
have no stake in grant awards. The stem-cell agency rejected that
step because it would require changing Prop. 71, either through a
super-majority in the Legislature or another ballot measure. That
excuse should be a vivid warning to Californians about the dangers of
passing complex, costly and inflexible initiatives. 

“Agencies handling billions of
taxpayers’ dollars should not avoid good government practice or
basic fiscal safeguards. The stem-cell institute offers minor fixes
when it needs substantial changes — and legislators should not
accept that cavalier approach.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VQ9QZ0E814c/riverside-newspaper-ethical-minefield.html

No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim

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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.”

We
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.

In
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.
Let’s
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
John
Reed
In
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.
New
Faculty Awards
When
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.
John
Sladek
In
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.
The
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.
Ted
Love
Mr.
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.
In
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.
Venture
Capital Firm
Mr.
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.
Stem
Cells, Inc.
Mr.
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.
Allegation
of Conflict at Board Meeting
As
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.
Saira
Ramasastry and Laurence Elias
Mr.
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”.
Diane
Winokur
Mr.
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.
Press
Releases
Finally,
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.
Mr.
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:
Generally
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.
That
is like saying a burglar who was caught in the act before he escaped
with his booty committed no offense.
The
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.
As
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?
Regarding
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.)
CIRM's
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.”   
Reed's
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.”

The
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.
The
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.
As
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zwk3dz23Ewc/no-improper-influence-cirm-defends-no.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

CIRM’s Thomas: Conflicts ‘Put to Bed’ at Stem Cell Agency

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The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, today hailed board
action last week as putting “to bed once and for all” questions
about financial conflicts of interest by members of the agency's
governing board.

Writing on the agency's blog, Thomas
pointed to board approval of a new policy that would bar 13 of the 29
members of the governing board from voting on any grants whatsoever.
The 13 are the members who are “appointed from an institution that
is eligible to receive money.” Three other board members have ties
to institutions that receive money. Two are employees of the institutions and one is the
chair of the University of California board of regents, Sherry
Lansing. All three are appointed as patient advocate members of the
board. Currently all 16 are barred individually from voting on grants
to their institutions, but they can vote for awards to other
institutions.
Thomas proposed the plan last week to
the governing board, which approved it on a 23-0 vote with one
abstention. Thomas advanced the proposal in response to the
recommendations of a 17-month study by the Institute of Medicine(IOM).
CIRM paid $700,000 for the blue-ribbon report, hoping that it would
serve as the basis for continued financing of the agency beyond 2017,
when funds for new grants run out.
The IOM's far-reaching recommendations
included creation of a majority of independent members on the board,
which would mean some current members of the board would lose their
seats. No institutions would be guaranteed seats on the board.
Currently five members are appointed from the University of
California. The Thomas plan does not deal with those recommendations.
The IOM said “far too many” members
of the board have ties to institutions that receive funds from CIRM.
Compilations by the California Stem Cell Report show that about 90
percent of the $1.7 billion that the board has awarded has gone to
institutions linked to directors.
Thomas said that the board last week
“endorsed a framework of proposals that would dramatically change
the way the board works, and directly addresses the concerns and
recommendations of the IOM, in particular their feeling that the way
our Board works could create a perception of conflict of interest.”
Concerning the change in voting for the
13 board members, Thomas wrote,

“It was not an easy change to propose
and certainly not an easy one for our board members to approve. They
all care deeply about our mission and devote a great deal of thought,
time and energy to helping us do our work. So for 13 of them to agree
to abstain from a key aspect of their work was difficult to say the
least. And yet they did it because they felt it was important for the
overall goal of the agency.”

Thomas continued,

“So why did we take this approach?
It's simple. We want people to focus on the great work we do, on the
groundbreaking research we fund, and the impact we are having on the
field of regenerative medicine not just in California but throughout
the U.S. and around the world. As long as there are perceptions of
conflict of interest hanging over the Board, this will continue to be
difficult.”

Thomas said,

“This puts the economic conflicts
issue to bed once and for all.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GHXrGjkYixw/cirms-thomas-conflicts-put-to-bed-at.html

Debunking California Stem Cell Agency Claims of ‘No Actual Conflicts’

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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.
Nonetheless, the statement has been
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.
The reason? Conflicts of interest were
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.
The facts are that the agency has a
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.
In 2009, board member John Reed, then
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.
In 2007, other violations involving five board members resulted in voiding applications from 10
researchers seeking $31 million. And then the agency shamefully scapegoated employees for the problem.
In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another
violation, which the agency felt necessary to report to the
California legislature.
In 2009, then board member Ted Love,
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.
Since 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, has received $7.1
million in awards from the agency. The contributions were 25 percent
of the total in the campaign, which was headed by Klein.
Another firm, StemCells, Inc., last
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. 
In 2008, public complaints by one
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. 
The agency has hired at least two
industry consultants in positions that raise conflict of interest
problems, in 2010 and again in 2012.
Sometimes groups expect to see
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."
The conflict issue even surfaces in picayune ways. In 2006, board members from various institutions spent
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.
All this, and yet on Jan. 24, 2013,
CIRM Chairman Jonathan Thomas was quoted in a CIRM press release as
saying “no one has found any actual conflicts” at the
agency.
In the media, some of the recent news
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."

Nonetheless, the IOM report said “far
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 fundamental conflict problem with
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.
Conflict problems are not unique to
CIRM and government agencies. They are also a matter of concern at
nonprofit, grant-making foundations, which in some ways CIRM
resembles.
The Council on Foundations, a
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.”

In the case of the stem cell agency,
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.
Perhaps it would be wise for the board
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lRsZniTbXbU/debunking-stem-cell-agency-claims-of-no.html

UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency

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The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.

None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.
“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient,  used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”
He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”
He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,

“Far too many board mem­bers
represent organizations that receive CIRM funding or benefit from
that funding. These com­peting personal and professional
interests com­promise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board."

Knoepfler said,

“(The) IOM itself admits there is no
evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”

Knoepfler also wrote,

“Interestingly, highlighting the
extremely sensitive nature of this issue, while I’ve been talking
with many bigwigs about this, at this point no one is wiling to go on
the record with an opinion about it except one courageous soul, Don
Reed (see
his piece here).”

There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.
California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pW_1A2nkyrM/uc-davis-stem-cell-researcher-ivory.html

Meager, Meager Coverage of Yesterday’s IOM-Stem Cell Meeting

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The $3 billion California stem cell
agency seemed all but invisible this morning in terms of mainstream
media coverage.

Only one major outlet reported on
the watershed events yesterday at the CIRM governing board meeting at
the Claremont Hotel in Oakland – at least from what our Internet
searches show.
The piece was written by Bradley Fikes
in the San Diego U-T, the dominant daily newspaper in that area,
which is a major biotech center. The major media in the San Francisco
Bay area, home to the stem cell agency and also a biotech center, were absent from the coverage.
Fikes wrote a straight forward account
of the meeting, saying that the governing board voted “ to
accept in concept proposed
changes to reduce conflicts of interest on the agency's
governing committee.”
Fikes wrote the story based on the audiocast of the meeting. He probably would not have written his daily piece without the availability of the audiocast. 
Some of those connected with the stem
cell agency often wonder about the lack of mainstream coverage of its doings,
particularly the lack of favorable coverage.
Much of it has to do with the shriveled
state of the media business, which is understaffed and overworked
compared to 15 years ago. Specialized science reporters are all but
an extinct species. Also, the mainstream media has traditionally
ignored the affairs of most state agencies.
Speaking as a former editor at a major
Northern California newspaper, I would not have sent a reporter to
cover this week's two-day CIRM board meetings. It would have consumed
too much valuable time with little likelihood of a major story,
especially when weighed against other story possibilities. There was
no guarantee that the board would have even acted. The events and
their significance could be better handled in a roundup story later
with more perspective, perhaps keying on the board's meeting in
March, where details of yesterday's action will be fleshed out. The
fact is that many, very important events occur within state
government every day that never receive media attention. Some don't
even see the light of day until a catastrophe occurs.
All of this may be deplorable in the
eyes in stem cell agency backers and others, but it is the reality of
today's news business.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8q4FDQb-BUk/meager-meager-coverage-of-yesterdays.html

IOM’s Shapiro Wants to See More Changes from California Stem Cell Agency

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Additional mainstream media news
coverage surfaced last Friday involving the California stem cell
agency's response to the blue-ribbon report from the Institute of
Medicine(IOM), whose concerns about the agency ranged from conflicts of interest to grant
appeals by rejected researchers.

One of the more interesting pieces was
done by Stephanie O'Neill of Los Angeles radio station KPCC. To her
credit, she contacted the chairman of the IOM panel, Harold Shapiro,
for his fresh take on what the stem cell agency's board did on
Wednesday.
His comments were somewhat different
than those read Wednesday at the CIRM board meeting. On Friday, Shapiro was quoted as
saying the board action was “an important first step forward,”
but he added a caveat. O'Neill wrote,

“'I’m encouraged by this,' Shapiro
told KPCC. 'Presumably in the future they’ll take other steps. But
these are steps they could take without any legislative approval and
…I think it does respond in a pretty significant way to the spirit
of the report.'
“But Shapiro expressed concern that
the agency is making only 'small moves' to address a recommendation
that CIRM separate operations from oversight. Currently, the ICOC
functions 'both as an executor and as an overseer—competing duties
that compromise the ICOC’s critical role of providing independent
oversight and strategic direction,' according to the December IOM
report.
“'But  I do understand… that
would be a move that they would have to take over time so we’ll
have to wait and see,' Shapiro said.
“Thomas agreed and said that while
CIRMs recommendations more clearly define the roles of chairman and
president, more refinements will be likely over time.”

From the Los Angeles Times, came a
piece from Eryn Brown. Her article was brief and she referred her
readers to the California Stem Cell Report for details. Her first
paragraph said,

“Changes may be on the way at
California’s stem cell funding agency.”

In coverage outside the mainstream media,
the Burrill Report carried an article by Daniel Levine. The Burrill
Report is produced by Burrill & Co., a San Francisco life
sciences financial firm. Levine's straight-forward account was
largely based on the CIRM press release and the IOM report.
Two bloggers surfaced with some
coverage. UC Davis stem cell researcher Paul Knoepfler, who is a CIRM
grantee, called the Thomas plan a “bold one-year experiment” and
“biggest development for CIRM in many years.” Knoepfler said,

“I’m still not sure I’m a fan of
all of the proposed changes, but I would say the plan is bold and
creative.”

On livingbiology.com, an unidentified
CIRM grantee carried a few brief items live from the meeting.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A2ayEbm2Se0/ioms-shapiro-wants-to-see-more-changes.html

Live Audiocast Available for Next Week’s CIRM-IOM Meetings

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The California stem cell agency will
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.
Instructions for hooking into the
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.
The audiocast will only provide the
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.
The meeting is scheduled for the
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XiZzHp3Zp_s/live-audiocast-available-for-next-weeks.html

Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency

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California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.

Reed says the recommendations by the
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.
Reed and CIRM's Amy Adams
World Stem Cell Summit photo
Reed is a fixture in stem cell circles
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency,  formally known as the California Institute for Regenerative
Medicine(CIRM).
Reed has written twice about the IOM
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,

“If its recommendations were enacted,
they would silence stem cell patient advocate involvement, eliminate
public debate on funding proposals, and delegate the real decisions
to secret proceedings by an out-of-state-controlled board.”

Reed described the stem cell agency as
“fantastic” and wrote,

“So why mess with it, in such a
brutal and insulting manner?”

This writer has known Reed since the
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.
While Bob Klein has not been heard from
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.
In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.
In 2010, he was the prime
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.
To keep the money rolling in, Klein
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.
According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,

“(We will) never convince the people
that are adamant against us. But for the public and for the
constituent groups that are reasoned and prepared to look at
evidence, this is a very important validation that they can look to
to separate out what is a false claim from real performance.”

Also writing yesterday about the IOM
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.
He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes
plans to file his own story within the next few days.
Feel free to file your own comments by
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/wX7BEi46lc8/patient-advocate-says-iom.html

Meager Coverage of Yesterday’s Bristling IOM-CIRM Meeting

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Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).

Only two pieces appeared, one in the
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
One of the recommendations of the IOM
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
Fikes wrote,

"'I'm a
colon cancer survivor,' said Art Torres, vice chairman of the
oversight committee, and a patient advocate designate. 'Does having
colon cancer make me biased?'
“Jeff
Sheehy, another patient advocate designate, protested what he called
a 'defenestration' of patient advocates, whose interests often span
multiple diseases.”

Ron Leuty of the San Francisco Business
Times skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Fikes also had a piece on ViaCyte,
which is in his area, receiving another $3 million from CIRM.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sTuRbsA7d_w/meager-coverage-of-yesterdays-bristling.html

BioTime Buys Geron’s Stem Cell Assets, Including hESC Clinical Trial

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Geron Corp., which pioneered the first
clinical trial of an hESC therapy, today sold its stem cell
business to another San Francisco Bay Area firm whose two top
executives were once CEOs at Geron.

Michael West
BioTime photo
The total value of the complex deal was
not clear from the public statements released by Geron and the
acquiring firm, BioTime, Inc., of Alameda, but an unidentified
outside investor is adding $10 million to transaction.
In a telephone interview this evening,
Michael West, CEO of BioTime, said that as a result of the deal his
firm will hold 600 patents and patent applications involving stem
cells. He said the aggregation should help in attracting financial
interest in the firm and its efforts.
West founded Geron in 1990. BioTime
Acquistion Corp., the BioTime subsidiary that is picking up the Geron
assets, is headed by Tom Okarma, who was Geron's CEO from 1999 to
2011.
After Okarma left the firm in 2011,
Geron abruptly jettisoned its stem cell business along with the
clinical trial. Geron has been looking since then for a buyer for the
assets.
Tom Okarma
Geron photo
Only a few months prior to the Geron
decision in 2011, the California stem cell agency had signed a $25
million loan agreement with Geron to support the clinical trial. The
company paid back with interest the amount of the loan that it had
received.
Information from the two companies did
not specify whether BioTime will begin seeking additional
participants in the clinical trial. Nor did BioTime indicate whether
it would seek additional funding from the state stem cell agency.
However, West said during the telephone
interview that he has an “open mind” about working with CIRM.
Last year, agency officials indicated an interest in continuing to
support the clinical trial. West said BioTime had already hired some
employees that were laid off by Geron, including its patent attorney.
He said that he hoped to reassemble at least part of Geron's now
scattered stem cell team.
According to the Geron press release,
when the deal is officially concluded in September, “it is
anticipated that Geron stockholders would own approximately 21% of
BAC, BioTime would own approximately 72%, and a private investor
would own approximately 7% after an additional $5 million investment
in BAC.”
For its new operations, BioTime has
leased space in Menlo Park that Geron once used for its stem cell
business.
Both firms are publicy traded.
BioTime's stock price closed at $3.45 today and had a 52-week high of
$6.35 and a low of $2.67. Geron closed at $1.60 and had a 52-week
high of $2.99 and a low of 91 cents.

Here is a link to an article in the San
Francisco Business Times about the deal. Here are links to the
BioTime press release, a BioTime FAQ and the Geron press release.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/TBbR-z7OPWc/biotime-buys-gerons-stem-cell-assets.html

Nature Biotechnology: California Stem Cell Agency Receives ‘Stinging Rebuke’

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The headline this week in Nature
Biotechnology read: “IOM smacks down California Institute of
Regenerative Medicine.”
The story by Senior Editor Laura
DeFrancesco said that the $3 billion California stem cell agency
“received a stinging rebuke of much of the way it has been carrying
out its business by a group of independent reviewers.”
At the same time, DeFranesco wrote that
the blue-ribbon, Institute of Medicine panel “praised the courage
and vision of the individuals who spearheaded the program as well as
those toiling in the CIRM office in San Francisco.”
The Nature Biotechnology piece covered
familiar ground for many readers, summarizing the IOM's sweepingrecommendations last month, including those dealing with the built-in
conflicts of interest on the agency's 29-member governing board.
DeFrancesco wrote that is unclear
whether the agency will move to adopt any of the recommendations from
the panel, many of which have been rejected in the past.
Some members of the CIRM governing
board last month bristled at some of the recommendations. The board is scheduled to discuss the IOM report, for
which it paid $700,000, at a public meeting Jan. 23 in Berkeley.
Patient advocates are already organizing a turn-out to lobby against
some recommendations.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bJIhSwMvwx8/nature-biotechnology-california-stem.html

A Singular Scientific Story: Duchenne’s Disease, a Family and the California Stem Cell Agency

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Unusual and personal conditions,
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA. 
Their research involves Duchenne
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
Carrie Miceli
UCLA photo
The researchers, Stan Nelson and Carrie
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
Miceli and Nelson have an 11-year-old
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
Adding to all this, their appeal used a
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
Stan Nelson
UCLA photo
Even prior to the IOM recommendation,
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
As for the $6 million CIRM grant, it will carry the important burden of advancing the findings that were published in the
journal Science Translational Medicine. However, the money was not used in the study reported today.
The research showed that dantrolene, the FDA-approved drug, “provides a powerful boost to
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
The news release said,

“(The researchers) hope this one-two
punch used in combination will overcome the genetic mutations that
cause DMD, restore a missing protein needed for proper muscle
function and allow those affected by the disease to lead relatively
normal lives.”

“Their youngest son, Dylan, 11, was
diagnosed with DMD in 2004. While he’s still ambulatory – many
DMD patients require the use of wheelchairs by about age 10 – Dylan
can no longer run or climb stairs and he can’t shoot a basketball
over his head like other boys his age.  Despite these
challenges, Miceli said Dylan remains a happy, funny and engaged boy,
full of life and passion.

“'We entered into this field because
of the diagnosis of our son, but we hope our research can help many
others,' she said. 'There are drugs that can help manage the symptoms
of the disease, but nothing that changes its course dramatically.
We’re trying to correct the defect that causes DMD with highly
personalized genetic medicine.'” 

UCLA said the grant from CIRM will be
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”

Asked for comment, Kevin McCormack, a
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,

"Clearly there is still a long way
to go before we know if this approach will work in people but we're
delighted that funding from the stem cell agency is helping  the
researchers move their work forward....This is what voters set out to
do when they approved Proposition 71 to create the stem cell agency."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/aAacD9507GI/a-singular-scientific-story-duchennes.html

Winners From Today’s Awards by the California Stem Cell Agency

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The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.

Here is the list of researchers who won awards today.

New Faculty Physician Scientist Translational Research Awards

RN3-06530Robert BalohCedars-Sinai Medical Center $3,031,737.00
RN3-06378Reza ArdehaliUniversity of California, Los Angeles $2,930,388.00
RN3-06504Jason PomerantzUniversity of California, San Francisco $3,084,000.00
RN3-06396Mana ParastUniversity of California, San Diego $3,013,252.00
RN3-06425Tracy GrikscheitChildren's Hospital of Los Angeles $3,408,000.00
RN3-06532Tippi MacKenzieUniversity of California, San Francisco $2,661,742.00
RN3-06479Ann Capela ZoveinUniversity of California, San Francisco $3,084,000.00
RN3-06529Alan ChengStanford University $3,091,595.00
RN3-06455Ali NsairUniversity of California, Los Angeles $3,004,315.00
RN3-06460Emanual MaverakisUniversity of California, Davis $2,964,000.00
RN3-06510Michelle MonjeStanford University $2,800,536.00
RN3-06525Ophir KleinUniversity of California, San Francisco $3,084,000.00
Total   $36,157,565.00

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html

Text of CIRM Chairman’s Comments on the IOM Report

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Here is the text of comments on the IOM study of CIRM from J.T. Thomas, chairman of the agency. 

"We deeply appreciate all the hard work of the IOM committee in compiling  long and detailed report and the IOM clearly put considerable thought into compiling it. This has just been released so our Board and our staff has not had a chance to look at it yet, let alone digest its findings and recommendations, so it’s premature for us to offer any opinions. We are looking forward to the IOM presentation at the next meeting of our board, the Independent Citizens Oversight Committee (ICOC) where we’ll have a chance to talk with the IOM directly about the report. After that we’ll put together a process on how best to proceed so that we can respond in as thoughtful a manner to the recommendations as the IOM did in making them."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YkRTcgnXNqU/text-of-cirm-comments-on-iom-report.html

Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’

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Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
Thomas did acknowledge that the report
“highlighted some areas and made some recommendations about where
and how we might improve our performance.” 
Thomas concluded by saying the agency
takes the report seriously and will, over the next few months,
consider how best to respond.
Nearly needless to say, other observers
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html