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Category Archives: Stem Cells

Monitoring the Cash and IP at the California Stem Cell Agency

The $3 billion California stem cell
agency appears unlikely to make any changes in who gets the cash from
any commercial products that its research grants help finance despite
recommendations from the Institute of Medicine(IOM).

The subject will come up next Wednesday
during a meeting of the intellectual property subcommittee of the
governing board of the stem cell agency. Intellectual property (IP) simply
determines ownership rights and the share of any revenue from
therapies that result from research.
CIRM staff has prepared a briefing paper with recommendations for next week's meeting, which has
teleconference locations in La Jolla, Los Angeles, two in Irvine
along with the main site in San Francisco.
The document summarized two key IOM
recommendations in this fashion:

“Because CIRM is a new institution
without a track record to reassure stakeholders, and because its
finite funding timeline means as yet unknown agencies will be
enforcing these policies years down the road, CIRM should “propose
regulations that specify who will have the power and authority to
assert and enforce in the future rights retained by the state” in
CIRM IP, specifically referring to march-in rights, access plans and
revenue sharing....

“Second, as other sources of funding
become more prevalent, the agency should “reconsider whether its
goal of developing cures would be better served by harmonizing CIRM’s
IP policies wherever possible with the more familiar policies of the
BayhDole Act.”

Here are the CIRM staff
recommendations.

“CIRM staff has engaged in
preliminary discussions several years ago with other agencies
regarding future enforcement of CIRM’s regulations and agreements.
Staff proposes to restart those discussions and return to the
Subcommittee (or the Board) with a formal proposal to address future
enforcement of CIRM’s IP regulations.”

“In light of the IOM’s own
recognition that it may be premature to assess whether CIRM’s
regulations will act as a deterrence to future investment, the fact
that a number of CIRM’s regulations have been codified in statutes
and CIRM’s positive progress in its industry engagement efforts to
date, although quite early, CIRM staff proposes to continue to
monitor this area and not to pursue any changes at this time.”

The director's subcommittee is unlikely
to diverge significantly from the staff proposal, which was dated
Feb. 14 but not posted on the CIRM website until Feb. 20.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xvosTob7Zo0/monitoring-cash-and-ip-at-california.html

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City of Hope Exec Will Leave California Stem Cell Agency Board

Michael Friedman
City of Hope photo
The governing board of the $3 billion
California stem cell agency will lose another one of its veteran
members this year – Michael Friedman, the CEO of the City of Hope
in the Los Angeles area.
He will join Claire Pomeroy in leaving
the board. Pomeroy is resigning as vice chancellor of Human Health
Services at UC Davis this spring to become president of the Lasker Foundation in New York.. Friedman is retiring at the end of this year.
Both have been on the CIRM board since
its first meeting in December 2004. Pomeroy was appointed by the UC
Davis chancellor. Friedman was appointed by the state treasurer.
No names have surfaced concerning
likely successors. However, the UC Davis chancellor is required by
law to appoint an executive officer from the campus. The new dean at
the UCD medical school would seem to be the most likely candidate.
To fill Friedman's seat, Treasurer Bill
Lockyer must appoint an executive officer from a California research
institute. The tradition on the board has been for particular
institutes to hold particular seats on the board. The major exception
is the Salk Institute, which lost a seat on the board a few years
back.
Both UC Davis and the City of Hope have
benefited enormously from CIRM largess. UC Davis has received $131
million and the City of Hope $51 million. Although Friedman and
Pomeroy have not been allowed to vote on grants to their
institutions, their presence and the presence on the board of other executives
from beneficiary institutions has triggered calls for sweeping changes at the agency.
A blue-ribbon report by the Institute
of Medicine said “far too many” board members are linked to
institutions that receive money from CIRM. The institute recommended
that a new majority of independent members be created on the board.
According to compilations by the
California Stem Cell Report, about 90 percent of the $1.8 billion the
board has awarded has gone to institutions with ties to past and
present board members. Fifteen of the 29 members of the board, which
has no independent members along the lines suggested by the IOM, are
linked to recipient institutions.
The agency has $700 million remaining
before money for new awards runs out in less than four years.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DWx8xx07ZOY/city-of-hope-exec-will-leave-california.html

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Half-full, Half-empty Editorial on California Stem Cell Agency

The California stem cell agency's
editorial road show paid off a bit again this week with a mildly
approving editorial in the Oakland Tribune.

The Feb.18 piece said that the presence
of Jonathan Thomas, a Los Angeles bond financier, as chairman of the
$3 billion agency has improved things, compared to the reign of Bob
Klein, who “built a protective shield” around the agency's
governing board and prevented action to deal with obvious
conflict-of-interest problems.
The newspaper also said that “to some
extent” the agency has brought “cutting edge” scientists to the
state and helped boost the stem cell field.
That was the half-full side of the
editorial. The half-empty side included the headline.

“California
must get its stem cell house in order”

The editorial continued:

“...{T)he agency must prove that it
understands how to properly handle the public's money. …. If
the stem cell agency can establish a record as a good steward of
public dollars to finance brilliant science, it can continue to play
a useful role in stimulating and guiding research to bring the
potential cures from stem cell research to fruition.

“If it cannot do that, it will be
just another expensive Tyrannosaurus rex.”

Thomas and company are knocking on
editorial doors around the state in hopes of building support for the
board's modest – some might say inadequate – response to
recommendations for sweeping changes at the agency.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tMt6gs55Yvs/half-full-half-empty-editorial-on.html

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Time For Public Disclosure of Financial Interests of Stem Cell Agency Reviewers

Should the scientists who evaluate
and score the applications for $3 billion in taxpayer funds be
required to publicly disclose their financial interests?

No, says the California stem cell
agency, despite concerns by the state auditor and the state's Fair
Political Practices Commission (FPPC) that date back at least six
years. The agency says that its governing board makes the decisions
on the applications – not the grant reviewers – and that the
members of the board fully disclose their economic interests.
However, last month the agency produced
a document that sheds new light on the issue. The document confirms
that the board rubber-stamps virtually all the reviewers' decisions,
going along with their actions 98 percent of the time. The board
exercised independent judgment on 28 out of 1,355 applications.
Why is this important? Here is what the state auditor said in 2007,

“(T)he FPPC believes that, under
state regulations, working group members (including grant reviewers)
may act as decision makers if they make substantive recommendations
that are, over an extended period, regularly approved without
significant amendment or modification by the committee. Thus, as
decision makers, working group members would need to be subject to
the conflict-of-interest code. This would mean that working groups
would be subject not only to the (public) financial disclosure requirements of
the Political Reform Act but also to the prohibition against a member
participating in a government decision in which that member has a
disqualifying financial interest and may be subject to the penalties
that may be imposed on individuals who violate that act.”

The auditor recommended that the stem
cell agency seek an attorney general's opinion on the matter, a
recommendation the agency agency summarily dismissed seven months later..
Then interim CIRM
President Richard Murphy, a former member of the agency's board and
former president of the Salk Institute, replied to the auditor:

"We have given careful
consideration to your recommendation and have decided it is not
appropriate to implement at this time. In almost three years of
operation and approval of four rounds of grants, the recommendations
of the CIRM working groups have never been routinely and/or regularly
adopted by the ICOC. Until the time that such a pattern is detected,
the question you suggest we raise with the attorney general is
entirely hypothetical, and is therefore not appropriate for
submission. We will, however, continue to monitor approvals for such
a pattern and will reconsider our decision if one emerges."

In the four rounds mentioned in
Murphy's response, 100 percent of reviewer decisions were
rubber-stamped by the board. In the other two rounds, the percentage
was 95 and 96 percent.
Currently, scientific grant reviewers at the stem cell agency, all of whom are from out-of-state, disclose financial and professional conflicts
of interest in private to selected CIRM officials. (See policy here.)
From time to time, grant reviewers are excused from evaluating
specific applications.
The CIRM governing board has resisted
requiring public disclosure of the interests of reviewers. The subject
has come up several times, but board members have been concerned
about losing reviewers who would not be pleased about disclosing
their financial interests.  Nonetheless, disclosure of interests among researchers is becoming routine in scientific research articles. Many universities, including
Stanford, also require public disclosure of financial interests of
their researchers. Stanford says,

“No matter what the circumstances --
if an independent observer might reasonably question whether the
individual's professional actions or decisions are determined by
considerations of personal financial gain, the relationship should be
disclosed to the public during presentations, in publications,
teaching or other public venues.”

The latest version of CIRM's conflict
of interest rules are under review by the FPPC. They do not include
any changes in public disclosure for grant reviewers. In view of the
new information that confirms that reviewers are making 98 percent of
the decisions on who gets the taxpayers' dollars, it would seem that it is long past due for public disclosure of both financial and professional
interests of reviewers. Indeed, given the nature of scientific
research and the tiny size of the stem cell community, disclosure of
professional interests may be more important than financial
disclosures.

"The public trust in what we do is
just essential, and we cannot afford to take any chances with the
integrity of the research process."

Here is the CIRM document concerning
reviewers' decisions and governing board action. The table has not
been posted on the CIRM website, but it was prepared for last month's
meeting dealing with the Institute of Medicine's recommendations for
sweeping changes at the agency, especially related to conflicts of
interest.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oma-MLcANoY/time-for-public-disclosure-of-financial.html

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San Jose Newspaper Lauds CIRM Chairman Thomas

The California stem cell agency got some good
news this week. The San Jose Mercury News ran an editorial yesterday
that was headlined,

“State stem cell agency is
taking Institutes of Medicine advice”
The 306-word editorial said CIRM
Chairman Jonathan Thomas is a refreshing change from Robert Klein,
the first chairman of the $3 billion enterprise. The brief editorial
said Thomas recognizes that the eight-year-old agency "has to mature." It said Thomas was trying to improve transparency and accountability.
The last paragraph declared,
 “If the stem cell agency can establish a record
as a good steward of public dollars to finance brilliant
science, it can continue to play a useful role in
stimulating and guiding research to bring the potential
cures from stem cell research to fruition.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZgT5-BiCODk/san-jose-newspaper-lauds-cirm-chairman.html

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No Improper Influence: CIRM Defends 'No Actual Conflicts' Claim

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