Earlier
this month the California Stem Cell Report published an item that said:
“In
the wake of recent considerable criticism concerning conflicts of
interest at the $3 billion California stem cell agency, its leaders
have taken to saying 'no actual conflicts' have been found at the
agency.
“That
assertion is simply not true.”
We
asked the stem cell agency if it would like to respond and said that
its response would be carried verbatim. The agency's comments are below. Our
take on the response follows the CIRM comments, which were authored
by Kevin McCormack, the agency's senior director for public
communications and patient advocate outreach.
In
David Jensen’s recent blog about the stem cell agency he claims to
“debunk” claims that there have been no actual conflicts in
CIRM’s funding decisions saying “the agency has a long history of
problems involving conflicts of interest, 'actual' and otherwise.”
In fact, in the cases cited by Mr. Jensen, show 'otherwise' is the
appropriate word here because as we’ll show CIRM’s conflict
procedures worked and the funding decisions were not affected by any
improper influence.
Let’s
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
John
Reed
In
2007, John Reed, a member of the stem cell agency’s Governing
Board, contacted staff in his capacity as the president of the
Burnham Institute after the Board approved a SEED grant award to a
Burnham investigator. Dr. Reed did not participate in the Board’s
decision to approve the award and played no role in that decision.
All he did was send a letter to CIRM staff after the Board meeting to
provide factual information in response to technical questions raised
by CIRM staff concerning the investigator’s eligibility for an
award. Those questions ultimately led staff to reject the grant.
Because the Board had already made the decision to award the grant,
it did not occur to Dr. Reed that the conflict rules would prevent
him from contacting staff to provide relevant information. And why
would it? The decision was made so there was nothing to influence.
After CIRM staff received Dr. Reed’s letter, they informed Dr. Reed
that he must refrain from participating in any way in CIRM's
consideration of the Burnham grant. In addition, CIRM staff did not
consider the letter in conducting their administrative review of the
Burnham grant and their determination that the investigator was not
eligible did not change. The FPPC determined that, although Dr.
Reed’s conduct raised ethical concerns, he had not violated
conflict of interest laws because he attempted to influence a
decision that had already been made. Furthermore, Dr. Reed’s
conduct did not affect a CIRM funding decision because the grant was
rejected by CIRM staff.
New
Faculty Awards
When
a candidate applies for a CIRM New Faculty Award it is standard
practice for them to include a letter of support from the institution
where they hope to be working. In December 2007, during a review of
applications for New Faculty Awards, CIRM staff discovered that ten
applications were accompanied by letters of institutional support
signed by members of the Board. This was due to a miscommunication by
staff, a poorly drafted memo to Board members leading them to think
it was OK to sign the letters of institutional support. The error was
discovered before the Board considered any of the applications. CIRM
staff determined that the letters could be perceived to create a
conflict of interest and so, to avoid even the appearance of a
conflict, CIRM staff disqualified the ten applications. As a result,
the applications were not presented to the Board for its
consideration, thereby avoiding any potential for a conflict of
interest in a funding decision.
John
Sladek
In
2011, while preparing the public summary for Basic Biology III
applications, CIRM staff discovered that Dr. John Sladek was one of
several co-authors on scientific publications with a researcher who
was listed as a consultant on a CIRM grant application. This is a
technical violation of the Grants Working Group (“GWG”) conflict
policy, which prohibits a member of the GWG from participating in the
review of an application if the member has co-authored papers with a
salaried investigator listed on a CIRM application within a three
year window. It should be noted, however, that Dr. Sladek’s
participation in the review of the application would not have
constituted a conflict of interest under state conflict of interest
laws because Dr. Sladek did not have a financial interest in the
application. In addition, the amount of funding involved –
approximately $3,000 of salary per year for three years, less than
one percent of the total award – was not material, and Dr. Sladek
did not stand to receive any financial benefit from the application.
Finally, Dr. Sladek’s participation in the review did not affect
the outcome because the application was not recommended, or approved,
for funding.
The
three instances cited by Mr. Jensen share two common features.
First, CIRM staff identified the potential for a conflict before any
funding decision was made. Second, CIRM’s funding decisions were
not affected by any improper influence.
Ted
Love
Mr.
Jensen also cites the service of Dr. Ted Love, a member of the Board
who volunteered his time to assist CIRM in offering his scientific
and medical expertise, as evidence of a conflict of interest.
Although Mr. Jensen insinuates that Dr. Love’s service constituted
a conflict of interest, he does not cite any facts, except Dr. Love’s
“deep connections to the biomedical industry.” But the fact that
Dr. Love has experience in the biotech industry does not constitute a
conflict of interest, and as a member of the Board and as a volunteer
to CIRM, Dr. Love abided by CIRM’s conflict of interest policies.
In
the past Mr. Jensen has criticized the stem cell agency for its lack
of connections and engagement with industry. In this case he
criticizes us precisely because of our connection and engagement with
someone who has industry experience.
Venture
Capital Firm
Mr.
Jensen also suggests that a conflict of interest arose from the fact
that “iPierian,Inc., whose major investors [a venture capital firm]
contributed nearly $6 million to the ballot measure that created the
stem cell agency, has received $7.1 million in awards from the
agency.” While it is true that Proposition 71 involved a
multi-million dollar campaign, the funding for the campaign came
primarily from individuals who had a family member who suffered from
a chronic disease or injury, including individuals associated with a
venture capital firm. The firm itself did not contribute to the
campaign, nor did the campaign accept contributions from
biotechnology or pharmaceutical companies. Furthermore, the venture
capital firm did not invest in a CIRM grantee; rather, it invested in
a different company which subsequently merged with yet another
company to form an entity that later applied for, and was awarded a
CIRM grant.
Stem
Cells, Inc.
Mr.
Jensen cites CIRM’s award to Stem Cells, Inc. as another source of
a conflict. In support of this claim, Mr. Jensen’s references Bob
Klein’s support of the award, as well as the fact that Irv
Weissman, PhD, appeared in an ad for Proposition 71 in 2004.
However, neither Mr. Klein’s support for the award nor Dr.
Weissman’s support for Proposition 71 constitutes a conflict of
interest. First, Mr. Klein, like any member of the public, has the
right to express his views to the Board. The state’s revolving
door laws do not apply to a former member of the Board who, like Mr.
Klein, is not compensated for making an appearance. As for Dr.
Weissman’s support for Proposition 71, nothing in state law
prohibits a member of the public from seeking CIRM funding even
though he supported the measure during the campaign. In fact, it
would be reasonable to expect that most stem cell scientists in
California (and elsewhere) supported Proposition 71. Disqualifying
individuals from receiving funding because they supported the law
would leave few, if any, eligible applicants.
Allegation
of Conflict at Board Meeting
As
further evidence of an “actual conflict”, Mr. Jensen cites
another instance in 2008 in which a representative of a for-profit
applicant publicly complained at a Board meeting that a member of the
GWG had a conflict of interest “from a business perspective.” As
provided for by CIRM’s regulations, the applicant had filed an
appeal, claiming that the reviewer had a conflict of interest because
he had a financial relationship with another company that was not an
applicant for CIRM funding. CIRM’s legal counsel reviewed the
appeal and determined that there was no conflict of interest under
CIRM’s policy.
Saira
Ramasastry and Laurence Elias
Mr.
Jensen cites two instances in which CIRM’s hired consultants in
support of his claim that CIRM has “actual conflicts of interest.”
In 2010, CIRM retained a partner at Life Sciences Advisory, LLC,
Saira Ramasastry, to assist CIRM’s External Advisory Panel, which
completed its work in December 2010. In 2012, Sangamo BioSciences,
Inc., nominated Ms. Ramasastry to serve on its Board of Directors.
Although Ms. Ramasastry continued to provide some consulting services
to CIRM through fiscal year 2011-12, none of her work for CIRM
involved Sangamo or any CIRM program in which it was involved. Ms.
Ramasastry’s services on behalf of CIRM did not create any conflict
of interest. The same is true of the second instance cited by Mr.
Jensen. In 2010, CIRM hired Dr. Laurence Elias, a former Geron
employee and an accomplished clinical development professional, to
provide CIRM with technical and regulatory input to ensure that the
clinical elements of an RFA were technically complete and accurate.
The concept for RFA had already been approved and as such Dr. Elias
was not in any position to influence the overall scope or structure,
nor did he have any role in evaluating applications. CIRM staff and
Dr. Elias complied with all conflict of interest requirements.
Neither contract led to an “actual conflict of interest”.
Diane
Winokur
Mr.
Jensen’s laundry list of “conflicts” also includes a reference
to the recent appointment of Diane Winokur to serve on CIRM’s
Board. Mr. Jensen quotes a representative of the ALS Association who
said that Ms. Winokur will be “a tremendous asset in moving the ALS
research field forward through CIRM funding." Of all the
insinuations made in his blog this is perhaps the cheapest shot,
taking aim at a woman who has dedicated her life to fighting a deadly
disease, one that claimed the lives of her two sons. Mr. Jensen knows
very well that the ALS Association does not speak for Ms. Winokur or
CIRM and while we expect that Ms. Winokur will bring her expertise as
an advocate for people suffering from ALS to the Board, she, like all
members of CIRM’s Board, represents all Californians, not just
those suffering from a particular disease. Ms. Winokur’s
appointment does not create a conflict of interest.
Press
Releases
Finally,
Mr. Jensen cites a Board debate from 2006 involving a requirement in
CIRM’s intellectual property regulations regarding press releases.
Under Health and Safety Code section 125290.30(g)(1)(C), the
discussion of standards does not create a conflict of interest, and
the Board’s debate was enriched by the participation of members who
brought their expertise and experience to bear.
Mr.
Jensen says that one of the reasons why the IOM did not report any
instances of conflict of interest in its report is that it did not
look for any conflicts of “inappropriate behavior,” But Mr.
Jensen was present in the public hearing at UC Irvine in April of
2012 when the IOM panel asked Stuart Drown, Executive Director of the
Little Hoover Commission that also looked into allegations of
conflict of interest at CIRM, if he could cite any actual instances.
Mr. Drown said he could not. Nor did Mr. Jensen offer any when it was
his turn to talk.
The view from the California Stem Cell Report:
Generally
speaking, CIRM's response about “actual” conflicts of interests
is a reiteration of what the California Stem Cell Report carried at
the time of each incident and does not add much new to the discussion
of the issues. All of the agency's earlier responses could be found in
the links in the “debunking” piece. Additionally the agency
confuses what are clearly actual conflicts with other instances that
could involve either actual or perceived conflicts, which the IOM
noted can be as deadly as the real thing. However,
in the most egregious cases involving Reed and later the five medical
school deans, the agency would like the public to believe that these
were not serious matters because the staff detected and caught the
conflicts before the grants were made.
That
is like saying a burglar who was caught in the act before he escaped
with his booty committed no offense.
The
acts were committed by members of the CIRM board, and they were
violations of conflict of interest standards. In the case of
the five deans, that is why the agency voided 10 applications
totaling $31 million from their five institutions. If there had been
no actual conflict of interest, that would not have been necessary.
As
for blaming the staff for “miscommunications,” the applications
that the five deans signed were quite clear and offered them the
option of having another person at their institution sign the grant
proposal. Other deans on the board did not sign applications in the
same round. Those applications were then handled in the normal
fashion. One might ask how in the world could the head of a medical
school who was also serving on the CIRM board NOT recognize a
conflict of interest when asked to sign a request for cash from the
board on which he served?
Regarding
John Reed and his conflict of interest violation, both he and then
CIRM Chairman Robert Klein have acknowledged Reed's actions
were wrong. Klein, an attorney who directed the writing of the
10,000-word measure that created CIRM, advised Reed to contact CIRM
staff to lobby on behalf of a grant that was approved by the board
but was about to be denied by staff.(See here, here and here.)
CIRM's
response contends that Reed's 6 ½ page letter was nothing more than
“factual” information dealing with technical matters. That is
hardly the case. In fact, Reed explicitly “emphasized” (Reed's word) that failing to comply with his letter would damage the future
of the stem cell agency. Denial of the grant, he said, “will surely
discourage clinical researchers from participating in the CIRM
mission to advance stem cell therapies.”
Reed's
action was inappropriate, and the California Fair Political
Practices Commission warned Reed about his actions. The journal Nature reported,
“California’s
Fair Political Practices Commission (FPCC) decided that Burnham
Institute President violated conflict-of-interest rules by writing a
letter to the California Institute of Regenerative Medicine appealing
a decision that an affiliate of his institute was ineligible for
funding.”
The
California Stem Cell Report's “debunking” piece went beyond "actual" conflicts to describe other instances where conflicts emerged.
Readers can go back to the original links for all the details, but
the cases of StemCells, Inc., and iPierian, Inc., are worth reviewing
again. Both cases involve fund-raising efforts that ran into
millions of dollars for the ballot measure campaign that created
CIRM. The campaign was run by Bob Klein who later became the agency's
first chairman, serving for six years and becoming something of a
hallowed figure in stem cell circles. One of the principal jobs of a
campaign manager is to raise the millions needed to run a successful
statewide election campaign in California. It is common for members
of the public to believe that major campaign contributors are
rewarded later for their contributions. Whether that was the case in
these instances, the reader must decide for himself or herself. But
the appearance is less than salubrious for an agency that claims to
have never seen an actual conflict of interest as it has handed out
$32,000 an hour, 24 hours a day, seven days a week during the last six
years.
The
facts are that about 90 percent of the $1.7 billion awarded by the
CIRM board has gone to institutions tied to present and past members
of its governing board. The agency, however, does work hard to be
sure legal conflicts do not arise during board action on grant
applications, using a voting procedure that is so convoluted that the
actual vote on nearly all applications is not even announced at board
meetings. Sometimes the procedure means that only a handful of
governing board members can participate in debate or vote. In the
case of the five medical school deans, as the board struggled to deal
with the fallout in 2007, only eight of the 29 members of the board could participate in the discussion because the rest had conflicts.
As
for CIRM's comments about “insinuations” and “cheap shots” by
the California Stem Cell Report, we naturally differ with that
characterization. The case in point involved what the chief scientist
for a patient advocate group said she expected as the result of a
recent appointment to the board. The scientist's remarks were offered
as example of the type of expectation and entitlement that can arise when governing
board members must be picked from specific constituencies, as is the
case with all 29 CIRM board members.
And as for my testimony at the IOM hearing last April, here is a link to my statement, which includes a discussion of conflicts of interest.
