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CIRM Director Prieto on Disclosure of Reviewer Financial Interests
Posted: March 3, 2013 at 3:07 am
A member of the governing board of the
$3 billion California stem cell agency is weighing in on an item on
the California Stem Cell Report that called for public disclosure of the financial interests of the scientific reviewers, who make 98
percent of the decisions on awards by the agency.
Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, said in an email:
physician and a patient advocate member of the board, said in an email:
“ It seems to me there's a bit
of 'damned if we do and damned if we don't' here. If the ICOC (the
agency governing board) decides to listen to some of the members of
the public who come to our meetings and overrule a recommendation of
the Grants Working Group(GWG), we're slammed for letting emotion trump
science, or bowing to special interests. If we just accept the
rankings of the GWG and approve all their recommendations, we're
criticized for not being truly independent. I think we don't do
it often (for good reason) but should and do retain the right to look
at other factors besides those our scientific reviewers do, and make
our own decisions about funding. We are ultimately responsible, not
the scientific reviewers.
“As for the issue of their
disclosure of personal conflicts of interest, from what I've read of
the NIH processes, ours are no less strict. The NIH requires that
reviewers disclose any conflicts to their institutions which I
believe must disclose them to the NIH, but I have not seen anything
requiring them to disclose all their personal financial & other
interests publicly, as we (ICOC members) have to. When we were
assembling our group of reviewers initially, the fear was that many
of the best scientists would turn us down if we required them to make
the kind of personal disclosures we have to. I don't know how many we
might actually lose if that were the case, but as you know we do
require them to disclose to CIRM, and they have to leave the room
when any application for which they have a conflict is discussed.”
Our take: Prieto is right about the
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
Proposition 71 placed the legal
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
Yet, if the board concedes the
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
The issues involving disclosure by
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
However, it makes little difference
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
The trend in the academic and
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
Our thanks to Prieto for his comments
on this important subject.
on this important subject.
Posted in Stem Cells, Stem Cell Therapy
Comments Off on CIRM Director Prieto on Disclosure of Reviewer Financial Interests
California Stem Cell Agency Bonds On Sale in March
Posted: March 3, 2013 at 3:07 am
Early next month, the state of
California will sell $2.7 billion in bonds, a tiny fraction of which will go
towards the California stem cell agency.
It is all part of an arrangement that
currently involves short-term borrowing as well to keep the cash
pipeline at CIRM properly filled.
currently involves short-term borrowing as well to keep the cash
pipeline at CIRM properly filled.
To refresh some of you, the agency
subsists off money that the state borrows (bonds) instead of going to
the legislature annually for financial support. While that avoids
competing against school children, the poor, the University of
California, state colleges, parks, highways and other interests
seeking state funding, it also means that the cost of a $20 million
grant is something closer to $40 million because of the interest
expense.
subsists off money that the state borrows (bonds) instead of going to
the legislature annually for financial support. While that avoids
competing against school children, the poor, the University of
California, state colleges, parks, highways and other interests
seeking state funding, it also means that the cost of a $20 million
grant is something closer to $40 million because of the interest
expense.
The California Stem Cell Report last
week asked the state treasurer's office about the bond sale March
12-13 and what it means for the stem cell agency. Here is what Tom
Dresslar, spokesman for the treasurer, replied in an email.
week asked the state treasurer's office about the bond sale March
12-13 and what it means for the stem cell agency. Here is what Tom
Dresslar, spokesman for the treasurer, replied in an email.
“CIRM’s funding needs now are met
via the issuance of commercial paper (CP). They’re authorized
a certain amount of CP periodically. Then we work with them on
a regular basis to issue the commercial paper on an as-needed basis.
Last fall, they were authorized $160 million of CP. We will
issue the first $27 million under that authorization (this) week.
This spring, CIRM is scheduled to receive another $100 million
authorization. The Department of Finance , consulting with CIRM
officials, determined the $100 million would be needed to meet CIRM’s
funding requirements through the end of 2013.“Now, here’s where it gets a little
complicated. The state pays down the CP with bond proceeds.
The March ....bond sale includes $60 million of stem
cell bonds. Those proceeds won’t provide new money for CIRM,
but will pay down the CP proceeds CIRM already has used.”
Proposition 71, which created the stem
cell agency in 2004, authorized bond sales for stem cell research for
only 10 years. CIRM's financial timekeepers say the clock started
running when the first bonds were sold. The upshot is that the agency
will run out of money for new grants in less than four years.
cell agency in 2004, authorized bond sales for stem cell research for
only 10 years. CIRM's financial timekeepers say the clock started
running when the first bonds were sold. The upshot is that the agency
will run out of money for new grants in less than four years.
Posted in Stem Cells, Stem Cell Therapy
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The Farrier's Role with Stem Cell Therapy – Video
Posted: March 1, 2013 at 9:46 pm
The Farrier #39;s Role with Stem Cell Therapy
At the 2013 International Hoof-Care Summit in Cincinnati, Ohio, Frank Reilly, DVM, talks about the farrier #39;s role in the use of stem cells.
By: AFJTV
Read the original:
The Farrier's Role with Stem Cell Therapy - Video
Posted in Stem Cell Therapy
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FRC's Dr. David Prentice Congratulates Kansas Senate for Passing Ethical Stem Cell Therapy Bill
Posted: March 1, 2013 at 9:46 pm
WASHINGTON, March 1, 2013 /PRNewswire-USNewswire/ --Family Research Council (FRC) Senior Fellow Dr. David Prentice, a native Kansan, congratulated the Kansas state senate for passing S.B. 199, a bill that would establish the Midwest Stem Cell Therapy Center, a regional hub to advance and deliver adult and cord blood stem cell therapies to patients and serving as a resource for adult and cord blood stem cells for therapies. The Center would also inform professionals and the public about such therapies.
(Logo: http://photos.prnewswire.com/prnh/20080930/FRCLOGO)
Dr. Prentice, a cell biologist who was selected by George W. Bush's Council on Bioethics to write a comprehensive review of adult stem cell research in 2004, testified before the Kansas Senate Committee on Public Health and Welfare in support of S.B. 199 on Feb. 25. Dr. Prentice additionally serves as adjunct professor of molecular genetics at the John Paul II Institute at the Catholic University of America, and formerly served as professor of life sciences at Indiana State University and adjunct professor of medical and molecular genetic at Indiana University School of Medicine.
The bill will now go to the Kansas House of Representatives for consideration.
In his testimony Dr. Prentice said:
"There are significant opportunities right now for Kansas to benefit from the establishment of a center of excellence specializing in the application of adult stem cell therapies for certain diseases, as well as educating physicians as well as the public about the advantages and availability of stem cell treatments.
"Kansas is moving forward as a potential leader in the area of adult and cord blood stem cell therapies. Estimates are that KU Med has done over 1,000 adult stem cell transplants, from bone marrow as well as a growing number from umbilical cord blood. These include stem cell transplants for various cancers and leukemias, but also initiating clinical trials to treat heart damage. Much more is possible.
"Kansas is well-positioned to become a leader in this area, and a global resource. The potential benefits for patients are incalculable. I urge you to support S.B. 199."
To read Dr. Prentice's testimony, click here: http://www.frc.org/testimony/testimony-of-dr-david-prentice-before-the-committee-on-public-health-and-welfare-kansas-senate
SOURCE Family Research Council
See the original post:
FRC's Dr. David Prentice Congratulates Kansas Senate for Passing Ethical Stem Cell Therapy Bill
Posted in Stem Cell Therapy
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LA Times: Stem Cell Agency Conflict-of-Interest Response Only a Bandage
Posted: February 28, 2013 at 2:02 pm
The Los Angeles Times yesterday modestly praised the $3 billion California stem cell agency for
taking some limited steps to deal with its longstanding conflict of
interest issues.
But the newspaper, which has the largest circulation in the state, said that was more was
needed if the agency plans to have a life after 2017, when funds for
new awards run out.
needed if the agency plans to have a life after 2017, when funds for
new awards run out.
The Times editorial said,
“After years of resisting all
criticisms of its operations, the California Institute for
Regenerative Medicine is finally listening — a little.“
The editorial continued,
“Yet the agency isn't exactly
embracing an ethical overhaul. It's doing just enough to address the
criticisms without triggering any oversight from the Legislature. The
modifications are more a bandage than a cure. Like a bandage, they
will probably do, but only for a limited time.”
The board plans to have 13 board
members with ties to recipient institutions voluntarily refrain from
voting on any grants that come before the board, not just the ones to
their institutions.
members with ties to recipient institutions voluntarily refrain from
voting on any grants that come before the board, not just the ones to
their institutions.
The Times said December's blue-ribbon
report from the Institute of Medicine identified the make-up of the
board as the “single biggest problem” at the agency. The
editorial cited figures prepared by the California Stem Cell Report
that show that about 90 percent of the $1.8 billion that the board
has awarded has gone to institutions linked to current or past
members of the board. Fifteen out of the 29 current board members
have ties to recipient institutions.
report from the Institute of Medicine identified the make-up of the
board as the “single biggest problem” at the agency. The
editorial cited figures prepared by the California Stem Cell Report
that show that about 90 percent of the $1.8 billion that the board
has awarded has gone to institutions linked to current or past
members of the board. Fifteen out of the 29 current board members
have ties to recipient institutions.
The editorial concluded,
“If the stem cell institute is just a
temporary agency that will last until its public funding runs out —
it plans to give its last grants with existing funds in 2017 — its
planned reforms will probably be enough. But if the institute wants
to be a permanent part of the research landscape — and possibly ask
for more public funding — voluntary recusals are an inadequate
patch. The agency's leaders should admit that the original setup was
flawed and seek a true fix. “
Posted in Stem Cells, Stem Cell Therapy
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Duke doctor: Stem cell therapy might help heart disease patients
Posted: February 27, 2013 at 1:44 pm
Durham, N.C. People with heart disease have more treatment options than ever. However, sometimes nothing gets rid of continued chest pain known as angina. Researchers say they are looking at a special stem cell therapy to help those patients.
Danny Darden, 49, has heart disease and frequent chest pain despite two years worth of every treatment, surgery and medication available to stop it.
If I walk around the block, I give out and have chest pains, he said.
Duke cardiologist Dr. Tom Povsic included Darden in a phase 3 trial looking for benefits of a special stem cell therapy to stimulate the growth of new vessels feeding blood to the heart.
In certain patients, the arteries can no longer be fixed, or bypass surgery can't be used to fix the arteries. And in those patients, novel therapies are sorely needed, Povsic said. So, the stem cells in this particular case are obtained from the patient themselves.
The cells, originating in the bone marrow, are stimulated and released into the blood stream, extracted and then administered directly into the heart through a special catheter.
Last week, I was injected with the stem cells, Darden said. I'm excited to be in it, because I feel it's going to work, and even if it (doesnt) work for me, it's going to work for other people.
The study is blind, meaning Darden may have received a fake infusion. Participants are followed for two years. A smaller previous study showed promising results.
The benefit that was seen in the early study far exceeds what was seen with many medicines that are approved for angina relief, Povsic said.
Researchers say if the stem cell therapy benefits are confirmed in patients with angina, it could also be studied in patients dealing with stroke, heart attack or heart failure.
Follow this link:
Duke doctor: Stem cell therapy might help heart disease patients
Posted in Cell Therapy, Stem Cell Therapy
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CIRM Director Prieto on Disclosure of Reviewer Financial Interests
Posted: February 27, 2013 at 10:09 am
A member of the governing board of the
$3 billion California stem cell agency is weighing in on an item on
the California Stem Cell Report that called for public disclosure of the financial interests of the scientific reviewers, who make 98
percent of the decisions on awards by the agency.
Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, said in an email:
physician and a patient advocate member of the board, said in an email:
“ It seems to me there's a bit
of 'damned if we do and damned if we don't' here. If the ICOC (the
agency governing board) decides to listen to some of the members of
the public who come to our meetings and overrule a recommendation of
the Grants Working Group(GWG), we're slammed for letting emotion trump
science, or bowing to special interests. If we just accept the
rankings of the GWG and approve all their recommendations, we're
criticized for not being truly independent. I think we don't do
it often (for good reason) but should and do retain the right to look
at other factors besides those our scientific reviewers do, and make
our own decisions about funding. We are ultimately responsible, not
the scientific reviewers.
“As for the issue of their
disclosure of personal conflicts of interest, from what I've read of
the NIH processes, ours are no less strict. The NIH requires that
reviewers disclose any conflicts to their institutions which I
believe must disclose them to the NIH, but I have not seen anything
requiring them to disclose all their personal financial & other
interests publicly, as we (ICOC members) have to. When we were
assembling our group of reviewers initially, the fear was that many
of the best scientists would turn us down if we required them to make
the kind of personal disclosures we have to. I don't know how many we
might actually lose if that were the case, but as you know we do
require them to disclose to CIRM, and they have to leave the room
when any application for which they have a conflict is discussed.”
Our take: Prieto is right about the
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
Proposition 71 placed the legal
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
Yet, if the board concedes the
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
The issues involving disclosure by
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
However, it makes little difference
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
The trend in the academic and
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
Our thanks to Prieto for his comments
on this important subject.
on this important subject.
Posted in Stem Cells, Stem Cell Therapy
Comments Off on CIRM Director Prieto on Disclosure of Reviewer Financial Interests
California Stem Cell Agency: Comparing the Critiques
Posted: February 27, 2013 at 8:22 am
State Controller John Chiang has posted
a useful, side-by-side comparison of critiques of the $3 billion
California stem cell agency, including the Institute of Medicine(IOM)
study, along with the responses from the agency.
Chiang, the state's top fiscal officer,
has additionally posted the initial remarks Jan. 23 by CIRM Chairman
Jonathan Thomas before the stem cell agency governing board on his
plan to deal with the sweeping recommendations of the IOM.
has additionally posted the initial remarks Jan. 23 by CIRM Chairman
Jonathan Thomas before the stem cell agency governing board on his
plan to deal with the sweeping recommendations of the IOM.
Regardless of one's opinion of the
board's response to the IOM, Thomas adroitly handled the discussion
and vote, not a small accomplishment given the size of the board (29
members) and the legal restrictions involving public meetings. Under
state law, Thomas could not lobby significant numbers of the board in
advance of the meeting. He was restricted to engineering the approval
in a public session, which can easily take on a life of its own given
the unwieldy size of the board and the necessity for public comment.
board's response to the IOM, Thomas adroitly handled the discussion
and vote, not a small accomplishment given the size of the board (29
members) and the legal restrictions involving public meetings. Under
state law, Thomas could not lobby significant numbers of the board in
advance of the meeting. He was restricted to engineering the approval
in a public session, which can easily take on a life of its own given
the unwieldy size of the board and the necessity for public comment.
As for the documents posted by Chiang,
he is chairman of the Citizens Financial Accountability and Oversight
Committee, the only state body specifically charged with oversight of
the agency and its board. The web site for the committee is the only
location on the Internet where Thomas' prepared remarks and the
comparison can be found.
he is chairman of the Citizens Financial Accountability and Oversight
Committee, the only state body specifically charged with oversight of
the agency and its board. The web site for the committee is the only
location on the Internet where Thomas' prepared remarks and the
comparison can be found.
Chiang's comparison chart includes not
only the IOM study, but last year's performance audit and the Little
Hoover Commission study in 2009. Missing, however, is the state
auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.
only the IOM study, but last year's performance audit and the Little
Hoover Commission study in 2009. Missing, however, is the state
auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.
Here are links to the various
documents: Thomas' prepared comments, Power Point chart used by Thomas,
comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.
documents: Thomas' prepared comments, Power Point chart used by Thomas,
comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.
Posted in Stem Cells, Stem Cell Therapy
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Group 52AM- Stem Cell Therapy – Video
Posted: February 26, 2013 at 7:46 am
Group 52AM- Stem Cell Therapy
Group 52 (BIOL1103/11:00AM) clearly illustrates the topic of Stem Cell Therapy through a class project based on a member of their own group who is considering Stem Cell Therapy.
By: Savannah Kelley
Read more:
Group 52AM- Stem Cell Therapy - Video
Posted in Cell Therapy, Stem Cell Therapy
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Group 62AM Alzheimer’s Stem Cell Therapy – Video
Posted: February 25, 2013 at 6:42 am
Group 62AM Alzheimer #39;s Stem Cell Therapy
Group 62AM #39;s video for Biology 1103 at UGA
By: Brooke Dillard
The rest is here:
Group 62AM Alzheimer's Stem Cell Therapy - Video
Posted in Cell Therapy, Stem Cell Therapy
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