San Jose Newspaper Lauds CIRM Chairman Thomas
February 17th, 2013 3:06 amThe 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,
|
Source:No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim
February 17th, 2013 3:06 amEarlier
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.
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.
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.
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
John
Reed
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.
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
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.
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
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.
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.
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
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.
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.
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
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.
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.
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.
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
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.
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
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”.
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
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.
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
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 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.
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.
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.
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.
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?
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.)
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.”
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,
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.
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.
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.
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:CIRM Board Member Prieto Critiques the IOM Stem Cell Report
February 17th, 2013 3:06 amFrancisco 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.
Source:Truncated dystrophins reduce muscle stiffness in the extensor digitorum longus muscle of mdx mice
February 17th, 2013 3:03 amMuscle stiffness is a major clinical feature in Duchenne muscular dystrophy (DMD). DMD is the most common lethal inherited muscle-wasting disease in boys, and it is caused by the lack of the dystrophin protein. We recently showed that the extensor digitorum longus (EDL) muscle of mdx mice (a DMD mouse model) exhibits disease-associated muscle stiffness. Truncated micro- and mini-dystrophins are the leading candidates for DMD gene therapy. Unfortunately, it has never been clear whether these truncated genes can mitigate muscle stiffness. To address this question, we examined the passive properties of the EDL muscle in transgenic mdx mice that expressed a representative mini- or micro-gene (H2-R15, R2-15/R18-23/C, or R4-23/C). The passive properties were measured at the ages of 6 and 20 mo a...
MedWorm Sponsor Message: Find the best Christmas presents and January Sales in the UK with this simple shopping directory.
Be Mine Forever: Oxytocin May Help Build Long-Lasting Love
February 17th, 2013 3:03 amIf cupid had studied neuroscience, he’d know to aim his arrows at the brain rather than the heart. Recent research suggests that for love to last, it’s best he dip those arrows in oxytocin. Although scientists have long known that this hormone is essential for monogamous rodents to stay true to their mates, and that it makes humans more trusting toward one another, they are now finding that it is also crucial to how we form and maintain romantic relationships.
http://rss.sciam.com/click.phdo?i=1e2c8b293a6e7840f25387be9dac539e
San Jose Newspaper Lauds CIRM Chairman Thomas
February 17th, 2013 3:03 amThe 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,
|
Source:No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim
February 17th, 2013 3:03 amEarlier
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.
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.
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.
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
John
Reed
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.
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
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.
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
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.
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.
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
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.
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.
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
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.
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.
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.
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
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.
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
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”.
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
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.
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
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 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.
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.
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.
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.
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?
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.)
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.”
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,
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.
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.
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.
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:CIRM Board Member Prieto Critiques the IOM Stem Cell Report
February 17th, 2013 3:03 amFrancisco 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.
Source:Stem Cell Surgery Study by Dr. Ruth Roberts of SDCM – Kidney Disease – Video
February 16th, 2013 6:43 am
Stem Cell Surgery Study by Dr. Ruth Roberts of SDCM - Kidney Disease
STEM CELL TRANSPLANT STUDY IN CATS AND DOGS POINTS TO GROUNDBREAKING TREATMENT FOR KIDNEY DISEASE Sabrina is a fourteen-year-old cat, diagnosed with kidney disease. Yet, Sabrina #39;s luck has changed due to a groundbreaking study in cats and dogs for the treatment of kidney disease. The research study by Dr. Ruth Roberts with Sun Dog Cat Moon Veterinary Clinic (SDCM) is stem cell transplant surgery. Sabrina #39;s procedure was on January 21, 2013. During surgery, stem cells were harvested from a four-ounce sample of her own fat tissue. "Modified stem cells find their way to the appropriate locations of the damaged kidneys, engrafting themselves into key areas for renal function, resulting in reduced inflammation, allowing regeneration of tissue and improved function in the kidney. There is a need in veterinary medicine for a regenerative treatment in kidney failure," says Dr. Ruth Roberts. For more information on Dr. Ruth Roberts #39; study on stem cell therapy for chronic renal failure in cats and dogs, please contact SDCM at 843-437-0063 and info@SunDogCatMoon.com Visit http://www.SunDogCatMoon.com Dr. Ruth Roberts DVM / CVA / CVH 843-437-0063 Info@SunDogCatMoon.com For media: Penelope Jean Publicist 615-568-5948 Penelope@PenelopeJean.com
By: Ruth Roberts
Link:
Stem Cell Surgery Study by Dr. Ruth Roberts of SDCM - Kidney Disease - Video
Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India – Video
February 16th, 2013 6:42 am
Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India
He is a known case of MD with history of gradual onset of lower extremities muscle weakness noticed since age of 12 years with complaints of footwear slipping, frequent falling, difficulty in stairs climbing and getting up from floor. Gradually weakness progressed to upper extremities with difficulty in overhead activities. He even reports difficulty in pronunciation of "Ra", "La". He has no family history of MD. Functionally, he is modified independent in all ADL and mobility. On FIM he scores 79. After Stem Cell Treatment 1. Feels more energetic. Stamina has improved. 2. Sitting posture has improved. 3. Walking and standing posture is more erect. 4. Balance while walking has improved. 5. He can maintain kneeling position. 6. Bending and rotation from trunk is easier because of increase in back extensor strength. 7. Slow rate of speech achieved. 8. Lisping reduced. 9. Correct articulation for fricatives /s/, /sh/ and velar /ksha/ achieved in isolation. Stem Cell Therapy done at Dr Alok Shrama NeuroGen Brain and Spine Institute Surana Sethia Hospital Sion-Trombay Rd, Suman Ngr Opp Corporate Park, Chembur, Mumbai -- 71. Tel : 022 - 25283706, 022 - 25281610, Mob : +91 9920 200 400 http://www.neurogen.in http://www.stemcellsmumbai.com
By: neurogenbsi
The rest is here:
Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India - Video
Beckers Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India – Video
February 16th, 2013 6:42 am
Beckers Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India
He is a known case of BMD since 10 years (2003). The difficulty initially started as difficulty in walking and stair climbing. Slowly weakness progressed and he could not get up from the floor. He went to the local doctor, who advised him to get investigations done. Investigations in 2005 showed Becker #39;s specific gene deletion, however diagnosis was confirmed as BMD based on clinical symptoms, increased CPK values and EMG changes that were consistent with BMD. On examination, he is hypotonic and hyporeflexic. There is hypertrophy of calf muscles and wasting of quadriceps and trunk muscles. There is slight tongue hypertrophy and slight difficulty in speech. He has complete passive range of motion. His upper extremities strength is above functional grade and he does the overhead activities. Out of all the antigravity muscles of lower limbs only plantar flexors are above functional level. Hip flexors are functional level and all the other lower extremities muscles are below functional level. Abdominals have functional level strength. Bilateral extremities are profoundly weak. Functionally he is independent in all ADL, however has great difficulty in getting up from lower surfaces. He needs support to climb staircase. On FIM he scores 104. After Stem Cell Treatment 1. Bilateral calf firmness has become softer than before. 2. He can now do supine to sit independently with ease, earlier he used to take strain and get up. 3. He can do sit to supine with ease than before. 4 ...
By: neurogenbsi
See more here:
Beckers Muscular Dystrophy Improvement After Stem Cell Therapy in Mumbai India - Video
Dr. Max Gomez Reports on Pope Benedict XVI Support of Adult Stem Cells – Video
February 14th, 2013 10:42 pm
Dr. Max Gomez Reports on Pope Benedict XVI Support of Adult Stem Cells
Dr. Max Gomez, Stem for Life Foundation Trustee, looks back at memories of Pope Benedict XVI from the 2011 Vatican Adult Stem Cell Conference and his new book, The Healing Cell, co-written with Dr. Robin Smith, President and Trustee of the Stem for Life Foundation, and Msgr. Tomasz, Trafny, Head of the Science and Faith Department of the Vatican #39;s Pontifical Council for Culture. He discusses the Pope #39;s support of adult stem cells. Video first aired February 11, 2013.
By: StemForLife
Excerpt from:
Dr. Max Gomez Reports on Pope Benedict XVI Support of Adult Stem Cells - Video
Silicon Beach: Howard Leonardt discusses innovations with Stem Cells – Video
February 14th, 2013 10:42 pm
Silicon Beach: Howard Leonardt discusses innovations with Stem Cells
Silicon Beach interviews Howard Leonhardt. Appointed by Startup America Partnership as spokesperson for the Jobs Act and Crowd Funding in their Startup California region.
By: M Jude Belanger
Read more:
Silicon Beach: Howard Leonardt discusses innovations with Stem Cells - Video
They laughed when I said I could print stem cells in 3-D but when I did… – Video
February 14th, 2013 10:42 pm
They laughed when I said I could print stem cells in 3-D but when I did...
http://www.stemcellsarthritistreatment.com Mesenchymal stem cell arthritis treatment is now a reality. Shoulder arthritis, hip arthritis, knee arthritis, and ankle arthritis are those areas that seem most amenable to treatment. The concern is how to obtain stem cells for arthritis treatment and how many to use. 3-D printing of stem cells is a new technology that appears to offer an alternative method for producing stem cells for arthritis treatment. http
By: Nathan Wei
Excerpt from:
They laughed when I said I could print stem cells in 3-D but when I did... - Video
Introduction to the Stanford Institute for Stem Cell Biology and Regenerative Medicine – Video
February 14th, 2013 10:42 pm
Introduction to the Stanford Institute for Stem Cell Biology and Regenerative Medicine
Institute stem cell researchers Michael Longaker, Ravi Majeti, Renee Reijo Pera, Michael Clarke and Maximilian Diehn talk about research on regenerative medicine, cancer therapies and reproduction, and how clinical experiences motivate them to work even harder to find new therapies for disease.
By: institutesofmedicine
See the original post:
Introduction to the Stanford Institute for Stem Cell Biology and Regenerative Medicine - Video
Stemlogix Stem Cell therapy at Central Animal Hospital St Petersburg Florida – Video
February 14th, 2013 10:41 pm
Stemlogix Stem Cell therapy at Central Animal Hospital St Petersburg Florida
Central Animal Hospital of St Petersburg, FL now offers in house Stemlogix Stem Cell Therapy for osteoarthritis for dogs! More info: http://www.centralanimal.net or http://www.tbk9rehab.com
By: StemLogixLLC
See original here:
Stemlogix Stem Cell therapy at Central Animal Hospital St Petersburg Florida - Video
What is the buzz about stem cells and synthetic scaffolds? – Video
February 13th, 2013 10:44 am
What is the buzz about stem cells and synthetic scaffolds?
http://www.stemcellsarthritistreatment.com Synthetics have the advantage of known rates of degradation, ability to keep shape, and reproducibility. The down side is that the adhesiveness of stem cells may not be as good as natural materials. Examples of these synthetic materials include various polymers such as poly lactic-co-glycolic acid and poly ethylene glycol. Initial studies using these materials as scaffolds has looked very promising. http
By: Nathan Wei
Read more:
What is the buzz about stem cells and synthetic scaffolds? - Video
Leggos for stem cells… you’ve got to be kidding! – Video
February 13th, 2013 10:44 am
Leggos for stem cells... you #39;ve got to be kidding!
http://www.stemcellsarthritistreatment.com Peptides are amino acids which are the building blocks of proteins. They can be assembled into scaffolds and have the advantages of being both reproducible as well as functional. Sort of like Leggos. http
By: Nathan Wei
Here is the original post:
Leggos for stem cells... you've got to be kidding! - Video
Stem cells technology for you – Video
February 13th, 2013 10:44 am
Stem cells technology for you
see how you can benefit from scientific breakthroughs and apply it for your health and beauty.
By: myjeunesse
See the original post here:
Stem cells technology for you - Video
Julia Greenstein Regenerative Medicine and Stem Cell Biology – Video
February 13th, 2013 10:44 am
Julia Greenstein Regenerative Medicine and Stem Cell Biology
This clip is part of the Career Girls ongoing series of career guidance/inspiration videos. See more at http://www.careergirls.org
By: careergirls
Excerpt from:
Julia Greenstein Regenerative Medicine and Stem Cell Biology - Video