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Category Archives: Stem Cell Therapy
San Jose Newspaper Lauds CIRM Chairman Thomas
Posted: February 13, 2013 at 6:39 pm
The California stem cell agency got some good
news this week. The San Jose Mercury News ran an editorial yesterday
that was headlined,
The last paragraph declared,
|
Posted in Stem Cells, Stem Cell Therapy
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No Improper Influence: CIRM Defends 'No Actual Conflicts' Claim
Posted: February 11, 2013 at 6:12 pm
Posted in Stem Cells, Stem Cell Therapy
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CIRM Board Member Prieto Critiques the IOM Stem Cell Report
Posted: February 10, 2013 at 4:13 pm
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.
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.
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.
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.
Posted in Stem Cells, Stem Cell Therapy
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Stem Cell Agency Board Member Defends Independence of Many on Board
Posted: February 10, 2013 at 3:06 am
A member of the governing board of the
California stem cell agency is taking exception to a statement on the
California Stem Cell Report that no independent members sit on that
body.
Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, referred to the
“ethical minefield” item Feb. 5, 2013. Here is the text of what
Prieto wrote,
physician and a patient advocate member of the board, referred to the
“ethical minefield” item Feb. 5, 2013. Here is the text of what
Prieto wrote,
“I have to object to this line: 'None
of the current members are independent. The ballot measure that
created the agency required board members to be appointed from
various constituencies.'
“I think I am absolutely independent,
and I think the same applies at the very least to most if not all of
my fellow patient advocates, and probably to the biotech
representatives as well – remember that they all must come from
companies that are not involved in stem cell research. Although
I supported the proposition, I was not involved directly in the
campaign in any way, and I did not meet Bob Klein (the first chairman of the stem cell board) or any of my fellow
board members until the day I was sworn in at our first meeting.
“The Prop. 71 language I believe
specifies that advocates must have a record of advocating for people
with the disease or diseases they represent, and not that they belong
to or work for any specific organization. Checking my binder,
it refers to 'groups' but does not specify those – for example, it
refers to 'representative of a California regional, state or national
HIV/AIDS disease advocacy group.' I’m not sure how you would
define 'independent' but I certainly don’t think it means
'disinterested.'”
Our take: The Institute of Medicine(IOM) called for a new majority of what it described as independent
members, obviously not finding sufficient, if any, independent
members on the agency board. The IOM, the most prestigious organization of
its kind in the country, said changes were needed because of damaging
conflict of interest issues at the stem cell agency.
members, obviously not finding sufficient, if any, independent
members on the agency board. The IOM, the most prestigious organization of
its kind in the country, said changes were needed because of damaging
conflict of interest issues at the stem cell agency.
Prop. 71, which created the stem cell
agency in 2004, was carefully crafted to avoid the use of the word
“independent” when describing the necessary qualifications for a
board member.
agency in 2004, was carefully crafted to avoid the use of the word
“independent” when describing the necessary qualifications for a
board member.
Instead the measure required that, in some cases, they
must come from very specific education institutions. (You can find the CIRM summary of all qualifications within this document.) In other cases, the speaker of the
state Assembly appoints “one representative of a California
regional, state, or national mental health disease advocacy group.”
The leader of the state Senate appoints “one representative of a
California regional, state, or national HIV/AIDS disease advocacy
group. “ Four other statewide elected officials appoint an
executive from a “California life science commercial entity.”
must come from very specific education institutions. (You can find the CIRM summary of all qualifications within this document.) In other cases, the speaker of the
state Assembly appoints “one representative of a California
regional, state, or national mental health disease advocacy group.”
The leader of the state Senate appoints “one representative of a
California regional, state, or national HIV/AIDS disease advocacy
group. “ Four other statewide elected officials appoint an
executive from a “California life science commercial entity.”
Prieto is correct when he says he
believes he is “absolutely independent.” But he fills a category
that represents a special constituency. What is missing from the
board is anyone who does not come from one special constituency or
another. The board was constructed in that manner to make sure it
would win the broadest measure of support from all the various major
constituencies by guaranteeing them a seat at the table where the
money is handed out. Ironically, the full formal name of the CIRM governing board is the "Independent Citizens Oversight Committee," a piece of political legerdemain to mask the actual nature of who would sit on the board.
believes he is “absolutely independent.” But he fills a category
that represents a special constituency. What is missing from the
board is anyone who does not come from one special constituency or
another. The board was constructed in that manner to make sure it
would win the broadest measure of support from all the various major
constituencies by guaranteeing them a seat at the table where the
money is handed out. Ironically, the full formal name of the CIRM governing board is the "Independent Citizens Oversight Committee," a piece of political legerdemain to mask the actual nature of who would sit on the board.
Posted in Stem Cells, Stem Cell Therapy
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Riverside Newspaper: ‘Ethical Minefield’ Still Not Cleared at Stem Cell Agency
Posted: February 10, 2013 at 3:06 am
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.
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.
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.”
Posted in Stem Cells, Stem Cell Therapy
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Debunking California Stem Cell Agency Claims of ‘No Actual Conflicts’
Posted: February 10, 2013 at 3:06 am
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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."
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.
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.
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,
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.
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.
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.
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,
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.
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.”
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.”
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Stem Cell Therapy Testimonial – Arthritis Treatment (full version) – Video
Posted: February 8, 2013 at 3:43 pm
Stem Cell Therapy Testimonial - Arthritis Treatment (full version)
Stem Cell Therapy Testimonial - Arthritis Treatment (full version) 1-888-545-4333
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Stem Cell Therapy Testimonial - Arthritis Treatment (full version) - Video
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Stem Cell Therapy Testimonial – Arthritis Treatment (Short Version) – Video
Posted: February 8, 2013 at 3:43 pm
Stem Cell Therapy Testimonial - Arthritis Treatment (Short Version)
Stem Cell Therapy Testimonial - Arthritis Treatment (Short Version) 1-888-545-4333
By: Bofitmiami
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Stem Cell Therapy Testimonial - Arthritis Treatment (Short Version) - Video
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Stem Cell Therapy Testimonial – Arthritis 1-888-545-4333 – Video
Posted: February 8, 2013 at 3:43 pm
Stem Cell Therapy Testimonial - Arthritis 1-888-545-4333
Stem Cell Therapy Testimonial - Arthritis 1-888-545-4333
By: Bofitmiami
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Stem Cell Therapy Testimonial - Arthritis 1-888-545-4333 - Video
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Stem Cell Therapy Webinar with Dr. Kamau Kokayi at Patients Medical – Video
Posted: February 8, 2013 at 3:43 pm
Stem Cell Therapy Webinar with Dr. Kamau Kokayi at Patients Medical
Join us as Dr. Kamau Kokayi, Director of Cell Technologies at the New York Stem Cell Treatment Center at Patients Medical in NYC explains what Adipose Derived Stem Cell Therapy is and what types of medical conditions Dr. Kokayi and his team of researchers are enrolling for the clinical trial.
By: PatientsMedicalNYC1
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Stem Cell Therapy Webinar with Dr. Kamau Kokayi at Patients Medical - Video
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