Category Archives: Stem Cell Therapy

The headline on the Los Angeles
Times web site this afternoon read,

"Is California's stem cell program
preparing to waste $700,000?"

"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."

"CIRM Chairman Jonathan
Thomas glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further." 

"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."

"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.' 

"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9CY8_m5Reqo/la-times-on-california-stem-cell-agency.html

The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.

 “This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/qtxtQt3nhU0/viacyte-wins-another-3-million-from.html

The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.

More than three years ago, the same issue was raised  and used by the agency to resist unwanted changes.

Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.

Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.

In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,

“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”

The California Stem Cell Report wrote at the time, 

"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."

The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .

Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6UqNIAVe5JY/constitutional-questions-raised-on.html

Carrie Miceli UCLA photo

Stan Nelson UCLA photo

“(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.'” 

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

As the Institute of Medicine began its presentation today to the governing board of the $3 billion California stem cell agency, one of its key directors, Sherry Lansing, pointed out that some of the IOM recommendations require legislative action and perhaps a vote of the people.

Her essential point was that the agency is hamstrung by the very measure that created it in 2004. She did not elaborate on her comment, but here is a look at some of matters she was talking about. (Lansing is chairwoman of the UC board of regents and former CEO of a Hollywood film studio.)

The ballot measure locked in management minutia and more, and then slapped on tight restrictions that make it nearly politically impossible to alter even such matters as who is in charge of production of the annual report. (By order of law, the chairman, in case you are wondering.)

And if the 29-member governing board -- so sized and specified to every nit and nat by the ballot measure -- wants to make the sweeping changes recommended by the IOM, agency directors face a formidable task in California's Capitol.

Many of
the most important recommendations for the California stem cell
agency require a vote of the California legislature and
signature of the governor. The IOM's choice of words – that these proposals “may” need legislation – is conservative. There is little doubt that legislative action would be needed to fully implement the recommendations below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xcudV6_VtGE/iom-report-many-major-changes-at-stem.html

Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.

Much  of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered  under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,

 "If you had some here, I would be more comfortable." 

He continued,

"We are not all powerful. We are a minority on the (29-member) board." 

Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,

"Advocates are here to advocate."

Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.

Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.

Director Robert Price of UC Berkeley said,

 "We have gone to great lengths to manage conflicts of interest."

The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.

 The IOM report 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(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”

More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.

J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.

No one from the public commented during the roughly 90 minute discussion.  Eighteen out of 29 board members were present at the beginning of today's meeting.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/m0FfxPnJUes/some-stem-cell-board-members-bristle-at.html

Two other major California newspapers
today said the $3 billion California stem cell agency needs to “clean
up its act” if it wants to be successful in continuing its efforts
at turning stem cells into cures.

“The $700,000 spent on the
study...will be wasted if the institute's oversight board fails to
heed the (IOM) committee's
criticisms, which echo the findings of the Little Hoover
Commission and other groups over the years.”

“The 29-member board is made up
almost entirely of representatives of advocacy groups and research
institutions that have a direct interest in how the money is spent.”

“The board also overrode the advice
of its scientific advisors — twice on a single application when it
considered a grant for a well-connected company, StemCells Inc. based
in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71,
which created and funded the agency in 2004, and its former head,
lobbied so intensively for the company that one board member
described it as 'arm-twisting.'"

“The agency has used more than half
of its funding and one day will almost certainly want to ask
taxpayers for more. It should remember that voters will look for
evidence of public accountability as well as respected research.”

“(I)f it wants to survive...it
should heed the Institute of Medicine's advice to eliminate conflicts
of interest on its board -- and do it before awarding the remaining
$1.2 billion of the $3 billion voters approved for stem cell
research.”

“Long-term funding was never the
intent when Proposition 71 passed in 2004. It was supposed to
kick-start research at a time when federal funding was blocked and to
establish California as a major player in the rapidly advancing
medical field. 

“The agency could continue to bring
value to the state as an advocate and funder of research, but only if
it can attract private donors, partners and investors. For that to
happen, it will need a board that passes the ethics test, with more
independent experts and industry executives free of conflicts. 

“At the outset, stem cell advocates
took immense pride in structuring the agency to keep it relatively
free of legislative interference despite the use of public money.
Politicians kept their hands off, which was good. But the agency
created its own inappropriate influences in the way it constituted
its board. Now it needs to clean up its act.“

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hjDmQPb6wDs/two-more-editorials-california-stem.html