The staff of the California stem cell agency is continuing with its overview of what the agency has done with the $1.7 billion it has awarded in terms of science. Thirty-eight percent of the amount has gone for translational research, efforts at turning basic research into a product. Here are links to a document on the science program and the Power Point presentations.
With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Showing posts with label IOM. Show all posts
Showing posts with label IOM. Show all posts
Wednesday, January 23, 2013
California Stem Cell Agency Directors Begin IOM Meeting
The board of the California stem cell agency has begun its meeting today dealing with the recommendations of the Institute of Medicine. The first order of business is a staff report on the scientific portfolio of the agency. The nitty gritty of the IOM report is scheduled to taken up about 1:15 p.m. PST.
Inside the Grant Review Process at the California Stem Cell Agency
One of the major issues today involving
the California stem cell agency and the Institute of Medicine
revolves around the grant review process, appeals and conflicts of
interest.
The agency has prepared a presentation
of how it perceives the process. The Institute of Medicine has also
described the review process. Both descriptions offer different sorts
of insights into the procedures.
We are offering both characterizations.
Both have at least one error and other limits. The IOM, for instance,
says grant applicants who file extraordinary petitions are invited by
CIRM to make public presentations to the board. That is not the case.
CIRM's presentation refers to a second
tier category for applications, a category that has not been used for
some time by the agency. The agency also says that it provides to the
public in advance of board meetings statistics on the spread and
deviation of reviewer scores on applications. That is not the case.
The material, a key board tool for evaluating appeals, has generally
not been available to the public until the day of the meeting, if
then. Sometimes it has only been available via a Power Point
presentation on a screen at the meeting. The CIRM slide on executive
sessions says that board members do not discuss merits of an
application in executive session. That assertion is marginal at best.
Last September, statements by the chairman of the board clearly
indicated that such a discussion occurred during an executive session.
From our attendance at other meetings, it seems abundantly clear that
discussions do occur in executive session.
We have queried the agency
concerning the statements in the grant review presentation document.
Readers should also be aware that grant reviewers make the de facto decisions on grants, although the board has final legal authority. The board has almost never rejected a grant approved by reviewers. The board also goes along with reviewers on the vast majority of applications that are rejected. The board, however, does pick a few applications not favored by reviewers in each round and approves them.
Readers should also be aware that grant reviewers make the de facto decisions on grants, although the board has final legal authority. The board has almost never rejected a grant approved by reviewers. The board also goes along with reviewers on the vast majority of applications that are rejected. The board, however, does pick a few applications not favored by reviewers in each round and approves them.
That said, both of descriptions are
helpful in understanding the process. Here is a link to the text of the IOM description. The CIRM description is embedded in a document on its web site and can be found as exhibition B.
IOM Description of CIRM Grant Review Process
Here is the text of the Institute of
Medicine's description of how the grant review process works at
California stem cell agency. You can find CIRM's version as exhibit B in this document.
"The GWG is appointed by the ICOC and consists of 23 members, including the chair of the ICOC, 7 of the 10 ICOC patient advocates, and 15 non-California scientists known for their expertise in stem cell biology (CIRM, 2009f, 2012g). The 15 scientists are selected based on the particulars of the individual RFAs and are drawn from a pool of more than 150 individuals chosen by CIRM as highly qualified to review proposals. Participation of these experts, none of whom, as non-Californians, are eligible for CIRM funding and stand to gain directly from CIRM, is instrumental in providing the rigorous scientific review required for making funding decisions. The success CIRM has had in commissioning outstanding review committees for each of its RFAs is a testament both to the Institute’s stature in the eyes of the stem cell community and the willingness of stem cell scientists outside of California to contribute their time and effort to facilitate the work of their California colleagues.
"CIRM staff are available to potential
applicants to discuss ideas and to answer questions about published
RFAs and the conformity of a particular proposal to the goals of
announced programs. From responses to a questionnaire submitted by
the committee to the California stem cell scientific community, 4 it
appears that views on discussions of this type vary, with some
individuals being highly appreciative of these preliminary
discussions and others finding the CIRM staff less accessible (IOM,
2012d). The committee agrees that having a system for communicating
with potential applicants early in the process is important, in
particular to ensure that neither applicants nor CIRM staff are
spending large amounts of time writing or assessing proposals that
are not in keeping with the goals of any particular RFA. The
committee also suggests that CIRM continue making its scientific
staff available to potential applicants and working with this
constituency to maximize the effectiveness of this aspect of the
grant submission process.
"CIRM staff recognized that the number
of applications that would potentially be received for a given RFA
could overwhelm the Institute’s ability to review each rigorously
for scientific merit. Accordingly, during its early years, CIRM
restricted the number of applications that would be accepted from any
one institution in response to a particular RFA. The reasoning was
that doing so would limit the overall number of applications, making
the review process manageable while guaranteeing that applications
would represent the scientific communities at a wide range of
California institutions. This was especially important given that
CIRM’s enabling legislation limited administrative expenditures,
requiring that the process for grant-making decisions be streamlined.
However, there was considerable pushback from potential grantees, as
it was thought that some individuals, in particular junior
investigators or those new to stem cell biology, were at a
disadvantage in competing with colleagues at their home institutions
for the right to submit a proposal and hence had limited access to
possible CIRM support.
"To address this concern while keeping
the number of proposals sent for full review manageable, CIRM
established a pre-application procedure and eliminated the
restriction on the number of applications that could be submitted
from any single institution (CIRM, 2011d). The preapplication
procedure is similar to a process used by a number of private
foundations that provide support for biomedical research. Applicants
are asked to provide a shortened version of their proposal through
the CIRM website. CIRM staff evaluate these shortened proposals to
ensure that they are in keeping with the RFA. Those deemed responsive
to the RFA are then sent to three outside reviewers, who are also
provided the RFA. Each reviewer is asked to evaluate the
preapplication, indicating whether it should definitely, possibly, or
definitely not be invited as a full proposal. Additionally, each
reviewer is asked to identify proposals that are among the two to
three best in the group being evaluated by that reviewer (each
reviewer typically is given 10-25 pre-applications to consider). No
written critique is requested of the evaluators. Using these initial
external evaluations, CIRM staff determine which applicants will be
invited to submit full proposals. Once invited, proposals must be
based on the pre-application proposal that was submitted. There is no
appeal process for pre-applications that are not invited for a full
proposal submission (CIRM, 2011e).
"After the pre-application process was
piloted, applicants, reviewers, CIRM staff, and the ICOC board
members were surveyed regarding its acceptability (CIRM, 2011e). As
might be expected, applicants often expressed frustration that there
was no feedback on why their pre-application was not selected to move
forward. Additionally, in responses to the committee’s
questionnaire 5 , some principal investigators raised concern about
whether a short proposal contains sufficient detail for an informed
review (IOM, 2012d). On balance, however, there appeared to be
overwhelming support for the pre-application process, especially in
comparison with the previous model whereby there was a limit on the
number of applications that could be submitted from any single
institution (CIRM, 2011e). The committee agrees that, despite its
limitations, the current preapplication procedure opens up the
opportunity for CIRM funding to a broader cohort of investigators and
is, in principle, an appropriate process. The committee recognizes
the tension between providing applicants as much information as
possible and not overburdening reviewers, and suggests that CIRM
consider ways of offering applicants more information on the
shortcomings perceived in preapplications that were not selected for
further consideration.
"The Scientific and Medical Research
Funding Working Group, designated in most CIRM materials as the
Grants Working Group (GWG), is the entity charged with reviewing
scientific proposals and making recommendations to the ICOC (the CIRM
governing board) with respect to those that should be funded.
"The GWG is appointed by the ICOC and consists of 23 members, including the chair of the ICOC, 7 of the 10 ICOC patient advocates, and 15 non-California scientists known for their expertise in stem cell biology (CIRM, 2009f, 2012g). The 15 scientists are selected based on the particulars of the individual RFAs and are drawn from a pool of more than 150 individuals chosen by CIRM as highly qualified to review proposals. Participation of these experts, none of whom, as non-Californians, are eligible for CIRM funding and stand to gain directly from CIRM, is instrumental in providing the rigorous scientific review required for making funding decisions. The success CIRM has had in commissioning outstanding review committees for each of its RFAs is a testament both to the Institute’s stature in the eyes of the stem cell community and the willingness of stem cell scientists outside of California to contribute their time and effort to facilitate the work of their California colleagues.
"Full proposals received by CIRM by the
RFA deadline are entered into the CIRM database, and all GWG members
assigned to this review cycle declare any conflicts of interest with
any of the applications (CIRM, 2009g). Any GWG member in conflict for
a particular application is recused during discussions, scoring, and
final voting. The GWG members are then assigned applications for
which no conflict exists based on their unique expertise. Typically,
three external scientists review each application. The GWG can call
on additional specialist reviewers as needed if its own expertise is
insufficient to evaluate the science in any individual application
adequately. Prior to the GWG’s face-to-face meeting, each reviewer
and ad hoc specialist submits a scientific score (1-100, with 100
being best) and a written critique for each assigned application. A
meeting of the GWG is then announced on the CIRM website. This
meeting starts with a session open to the public, during which GWG
business is conducted. The GWG then meets in closed session for a
two-stage review of the applications (CIRM, 2011g).
"The first stage of the review is
scientific in nature, led by the chair of the GWG (an external
scientist member appointed to this role by the ICOC). The assigned
reviewers declare their scores for the application being discussed
and briefly summarize the basis for their recommendations. This is
followed by full discussion of the application by GWG members, ending
with the assigned reviewers suggesting revised scores based on the
discussion. Each scientific member of the GWG not in conflict with
that application then submits a final scientific score. Although ad
hoc specialist reviewers can suggest scores in their written
evaluations and, if present, during the discussion, only GWG members
can submit a final score. The final scientific score is the
arithmetic mean of the reviewers’ scores. If there is a wide
divergence in scores with a sizable proportion (greater than 35
percent) of the GWG being in disagreement with the majority view, a
minority report is forwarded to the ICOC along with the final score
(CIRM, 2011g).
"The next stage is the programmatic
review, chaired by one of the patient advocate members of the GWG
appointed to this position by the ICOC (CIRM, 2011g). The purpose of
this review is to evaluate all of the applications taking into
account not only their scientific scores but also the overall purpose
of the RFA, with the goal of segregating the applications into three
tiers— recommended, provisionally recommended, or not recommended
for funding. This process has two steps. First, a histogram of the
scores of all of the applications is generated. Of note, at this
stage the applications are deidentified, and only the scores are
revealed. The GWG examines this histogram and identifies natural
breaks to divide the applications into the three tiers based on their
scores. Next, the applications are identified so that the scientific
score (and tier) of each is made known. GWG members (except those
with conflicts, who leave the room) begin a discussion to determine
whether any of the applications should be moved from one tier to
another in an effort to achieve a balanced portfolio representing a
spectrum of priority disease areas, scientific approaches,
innovation, and so forth. For an application to be moved from one
tier to another, a majority vote of the GWG is required; all members
of the GWG not in conflict (scientists and patient advocates)
participate in this vote. Once the GWG is satisfied with the final
ranking of proposals, a final vote is taken, and the rank order is
proposed to the ICOC for approval. For each application, in addition
to its final ranking, the scientific score voted by the scientists on
the GWG is provided to the ICOC (CIRM, 2011g; IOM, 2012e).
"The ICOC makes funding decisions at a
meeting scheduled and publicized in advance. As with other ICOC
agenda items, deliberations on the funding of applications begin in a
session that is open to the public. ICOC board members in conflict
with any particular application are recused from both this public
discussion and any subsequent private deliberations. Prior to the
ICOC meeting, summary information about each application is available
on the CIRM website, including how that particular application ranked
relative to the others and its tier designation.
"Applications are redacted, however, to
remove information that would identify applicants or institutions.
Individual applicants are aware of how their proposal scored and how
likely it is to be funded, and have the opportunity to make an
“extraordinary petition” to the ICOC. Any ICOC board member may
request that the petition be heard. In such cases, petitioners are
invited to the ICOC meeting to explain why they believe the assigned
score and priority ranking are not appropriate.(California Stem Cell
Report note: The preceding sentence is in error. Petitioners are not
invited to appear. In fact, some have not understood their right to
appear. Others do not even understand that they can file a petition.)
"The ICOC takes this information (the
petitions) into consideration as it deliberates about the final
ranking of applications. If it is necessary to discuss proprietary
information, the ICOC may meet in closed session before a final vote
is taken on which applications will be funded. As a result of its
private and public deliberations, the ICOC may move applications from
one tier to another before taking a final vote, after which
applicants are notified about funding decisions. Examination of ICOC
records indicates that the shifting of applications from one tier to
another does occur. For example, as of October 22, 2012, 62
extraordinary petitions were heard by the ICOC, of which 20 (32
percent) were successfully funded (CIRM, 2012h). While most of this
shifting is between adjacent tiers, there have been cases in which
applications have been moved from tier 3 to tier 1 (CIRM, 2011g; IOM,
2012e); this has occurred with applications for major programs with
large budgets. As discussed in greater detail below, the committee is
troubled by the extraordinary petition mechanism and suggests that
this practice be eliminated. The committee recognizes that CIRM has
recently initiated a self-study regarding all aspects of
extraordinary petitions."
Texas and California: Conflicts, Research Funding and Controversy
As directors of the $3 billion
California stem cell agency begin a critical meeting today that
involves both its future and conflicts of interest, a move is afoot
in Texas to cut off funding for a similar research organization
embroiled in controversy over its grant review process and
favoritism.
The Texas Tribune in Austin yesterday
reported that a Republican legislator has introduced a measure that
could ending funding for the $3 billion Cancer Prevention and Research Institute in that state. Both the Texas organization and
the California agency rely on money (bonds) that is borrowed by their
state governments. Other separate kmoves are also underway in the Texas
legislature to make major changes in the research funding.
The Texas agency has been involved in
controversy over its grant review procedures for months. The issues
have led to mass resignations of its reviewers and persistent public
turmoil. In California last fall, CIRM President Alan Trounson warned about the implications of the Texas flap for his agency. Later in December, the blue-ribbon report by the Institute of
Medicine about CIRM said the Texas situation “illustrates the
importance of rigorous scientific review free from inherent or
perceived conflict and the consequences when these boundaries appear
to be breached.”
The IOM study of CIRM said “far too
many” of the agency's directors are linked to organizations that have
received CIRM grants. A compilation by the California Stem Cell
Report shows that about 90 percent of the $1.7 billion awarded by the governing board have gone to institutions with ties to directors.
The IOM inquiry, commissioned by CIRM
at a cost of $700,000, recommended that a majority on the 29-member
CIRM governing board consist of "independent" members. Currently the
board has no “independent” members. They come from legal
classifications that range from patient advocate to five “executive
officers” from five different University of California campuses.
Industry is only marginally directly represented on the board. The
specific classifications can be found in this CIRM document.
Today's meeting begins at 10:30 a.m. PST in Berkeley. The California Stem Cell Report will provide live coverage of the sessions today and tomorrow via the audiocast that is available to the public. Directions for listening to the audiocast can be found on the meeting agenda.
Tuesday, January 22, 2013
California Stem Cell Agency: IP and Sustainability Off the Table Tomorrow
The California stem cell agency says
that tomorrow's meeting regarding the sweeping changes recommended by the Institute of Medicine (IOM) will not include discussion of
intellectual property issues or proposals for the “sustainability”
of the $3 billion enterprise.
In a memo to the governing board of the
agency posted on its web site today, James Harrison,
outside counsel to the board, said,
“The chairman (Jonathan Thomas) has conveyed his view that CIRM should maintain its existing policies regarding revenue sharing, pricing, and access. In addition, chairman Thomas is working on proposals to address the IOM committee’s recommendations regarding a sustainability platform, but it would be premature to discuss these proposals at this time. Therefore, we do not intend to devote significant time to either the intellectual property or sustainability platform recommendations. Instead, we hope to focus the discussion on governance issues and the application review process.”
The CIRM board begins a critical, two-day session tomorrow in Berkeley to consider the IOM's recommendations, which met
initial resistance last month from a number of the agency's 29 board
members. The recommendations would make major changes in the board
and would mean some members would lose their seats, if the proposals
were adopted without change.
The IOM also said that the board needs
to overhaul its conflict of interest standards, declaring that “far
too many” board members are tied to organizations that benefit from
CIRM's largess. The agency has long been a target of criticism that it
has conflicts of interests that were built in by Prop. 71, the ballot
measure that created the program. Roughly 90 percent of the $1.7 billion that the board has awarded has gone to institutions that are
linked to members of the agency's governing board, according to
compilations by the California Stem Cell Report.
Arthur Caplan, a prominent medical
ethicist at New York University, says that the IOM has concluded that
CIRM's grant award process is “insular and somewhat incestuous.”
Harrison's document was long on the
positive aspects of the blue-ribbon IOM study, which CIRM is paying
for at a cost of $700,000. It was commissioned by the board in 2010
with the intent that it would be a springboard to another
multi-billion dollar state bond measure, which requires voter
approval. CIRM operates on money that the state borrows (bonds). The
interest on the bonds will bring the total cost to taxpayers to
roughly $6 billion. The financial arrangement is unusual for research
funding and differs from federal funding, which is not based on
borrowed cash. The CIRM bond money, however, will run out in less than four years.
Harrison cited 10 points in which the
IOM had praise for CIRM, points that few would differ with in any major
way, even prior to the IOM study. Some might quibble, however, with a
few of Harrison's effusive adjectives.
Significantly, Harrison did not present a fresh legal analysis that might have raised the possibility of constitutional objections to the IOM proposals. A memo from Harrison in 2009 was used by then CIRM Chairman Robert Klein to box in the board in connection with other, similar suggestions for changes at the agency.
Harrison also disclosed that board's
intellectual property (IP)subcommittee will examine the IOM's
proposals on IP later and make recommendations. The IOM suggested,
among other things, that CIRM modify its policies to bring them in
line with federal law, which is not without its own controversies.
Tomorrow's session will be covered live
by the California Stem Cell Report via CIRM's audiocast, which is
available to the public, and we will file stories as warranted. The
meeting begins at 10:30 a.m. PST. Directions for dialing into the
audiocast can be found on the agenda for the meeting.
Saturday, January 19, 2013
StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency
Remember StemCells, Inc., and the $40
million it was awarded by the California stem cell agency.
The Newark, Ca., firm, founded by
eminent Stanford researcher Irv Weissman, received an award of $20
million last July and then again in September. Nearly five months
later, however, the stem cell agency has yet to cut a check for the
company, a spokesman for the agency told the California Stem Cell
Report in response to a query.
The hang-up is the $40 million in
matching funds that the company promised the agency. The stem cell
agency has yet to be satisfied that StemCells, Inc., can actually
produce the match, although the spokesman did not offer details.
The StemCells, Inc., awards were
unusual in a number of ways. It was the first time that former CIRM
Chairman Robert Klein lobbied the CIRM governing board on behalf of a
company(see here and here). It was the first time that the governing
board approved an application that had been rejected twice by grant
reviewers. It was the first time that the board said explicitly in a
public session that it wanted proof of the matching funds as a
condition of the award.
It was the first time that a CIRM award
to a company received a careful and critical scrutiny from a major
California newspaper. Michael Hiltzik, a Pulitzer Prize-winning
business columnist and author, wrote in October in the Los Angeles
Times that the award was “redolent of cronyism.” He referred
particularly to longstanding ties between Klein and Weissman.
The CIRM board vote on the StemCells,
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.
In December, a blue-ribbon panel of the
Institute of Medicine (IOM) recommended that the agency tighten its
conflict of interest standards to avoid such perceptions as have been
generated by the StemCells, Inc., awards. The IOM said,
“(C)ompeting personal and professional interests compromise the perceived independence of the (governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.”Concerns about conflicts of interest have long been of concern to observers of the stem cell agency for years. Indeed, the prestigious journal Nature in 2008 warned of "cronyism" at the $3 billion research enterprise.
Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations
The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, yesterday outlined how
he intends to proceed next week when the agency's governing board
considers the far-reaching recommendations of a blue-ribbon Institute
of Medicine panel.
Writing on the agency's blog, Thomas
said,
“While some of the IOM’s recommendations are administrative in nature and can be implemented, others are much more complex and would require changes in (governing) board policy or legislative changes.”
He continued,
“My goal is to strive to reach consensus on a course of action on the 23rd. However, if the board isn’t able to choose a course of action at this time we will continue the conversation and bring it up at future board meetings until we reach agreement.”
It is worth noting that Thomas did not
mention the possibility of having to ask the people of California to
amend the state constitution, which would require a statewide election. Opponents to change at the agency have
used that possibility to discourage action. (See here and here.) An
election would be costly, politically difficult and could open the
door to additional unwelcome changes at the eight-year-old research
enterprise.
Thomas' desire for a consensus among
the 29 board members – instead of a simple majority – could be a
stumbling block as the board becomes snarled internally, perhaps for
months or more. The board normally meets only about once a month and
has a full slate of regular business on those occasions. The agency
will run out of money for new grants in less than four years, and
action on the IOM recommendations seems a necessary prelude to
winning continued financial support.
While four years would appear to an ample
period of time, making the sort of changes the IOM recommends would
require legislative action, which probably would take a minimum of a
year. Timing is important as well. The current leaders in the state
Senate and Assembly will be termed out in 2014. Starting all over
with novice leadership, changes in key committee chairmanships and so
forth would make the task even more difficult. Then there is the need
to address strategies for continued financial support. Should the
agency seek a new statewide bond measure (the current funding
mechanism)? If so campaign committees need to be formed, electoral
strategies planned and tested and tens of millions of dollars raised
for campaign expenses. If private funds instead are to be raised to
the tune of hundreds of millions of dollars(the agency spends about
$300 million a year), such an effort would also require considerable time.
To keep the funding pipeline full, all of this should be completed
well before the money runs out in 2017.
Dilly-dallying this year in drawn-out, fruitless debate over
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.
In his blog item, Thomas sounded this
final note.
“It’s likely the debate will be passionate – everyone involved in this work cares deeply about it – and there will undoubtedly be disagreements, but ultimately we all share the same goal, a desire to make sure that whatever we decide helps make the stem cell agency even stronger and more effective, and is in the best interests of the people of California.”
Labels:
bond election,
cirm financing,
cirm future,
cirm legislation,
cirm managment,
IOM
Friday, January 18, 2013
UC Davis Stem Cell Researcher: 'Ivory Tower' IOM Recommendations Harmful to California Stem Cell Agency
The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.
None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.
“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient, used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”
He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”
He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,
“Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC, introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board."
Knoepfler said,
“(The) IOM itself admits there is no evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”
Knoepfler also wrote,
“Interestingly, highlighting the extremely sensitive nature of this issue, while I’ve been talking with many bigwigs about this, at this point no one is wiling to go on the record with an opinion about it except one courageous soul, Don Reed (see his piece here).”
There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.
California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.
Patient Advocate Says IOM Recommendations Would 'Destroy' California Stem Cell Agency
California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.
Reed says the recommendations by the
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.
Reed and CIRM's Amy Adams World Stem Cell Summit photo |
Reed is a fixture in stem cell circles
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency, formally known as the California Institute for Regenerative
Medicine(CIRM).
Reed has written twice about the IOM
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,
“If its recommendations were enacted, they would silence stem cell patient advocate involvement, eliminate public debate on funding proposals, and delegate the real decisions to secret proceedings by an out-of-state-controlled board.”
Reed described the stem cell agency as
“fantastic” and wrote,
“So why mess with it, in such a brutal and insulting manner?”
This writer has known Reed since the
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.
While Bob Klein has not been heard from
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.
In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.
In 2010, he was the prime
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.
To keep the money rolling in, Klein
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.
According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,
“(We will) never convince the people that are adamant against us. But for the public and for the constituent groups that are reasoned and prepared to look at evidence, this is a very important validation that they can look to to separate out what is a false claim from real performance.”
Also writing yesterday about the IOM
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.
He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes
plans to file his own story within the next few days.
Feel free to file your own comments by
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.
Labels:
IOM,
iom reaction,
klein,
Klein lobbying group
Thursday, January 17, 2013
Live Audiocast Available for Next Week's CIRM-IOM Meetings
The California stem cell agency will
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.
Instructions for hooking into the
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.
The audiocast will only provide the
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.
The meeting is scheduled for the
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.
Wednesday, January 16, 2013
California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations
Two days next week at the posh
Claremont Hotel in the Berkeley hills could settle the fate of
California's $3 billion stem cell agency.
The IOM report places a special burden
on the agency governing board. The board paid the IOM to evaluate its
performance. In 2010, then CIRM Chairman Robert Klein trumpeted the
value of an IOM study, saying it would serve as a springboard for a
new, multibillion-dollar state bond measure for the agency(see here and here). Given the
state's difficult financial condition – not to mention the position
of potential private sector investors – winning approval of that
kind of investment will be more than difficult.
At 9 a.m. next Wednesday, the governing
board of the state research effort will begin a critical, two-day
public session. On the table will be the $700,000, blue-ribbon
report from the prestigious Institute of Medicine (IOM). The study
recommends sweeping changes in the structure and operations of the
California Institute of Regenerative Medicine (CIRM), as the stem
cell agency is formally known.
The IOM report alone poses major
challenges for the agency. But the recommendations are freighted with
even more significance. Below the surface lies the hard fact of
CIRM's dwindling resources and possible demise. In less than four
years – without either renewed public support or private
contributions – the research effort will begin a shriveling,
downward spiral.
Claremont Hotel |
California's major newspapers already have editorially backed the IOM proposals. Indeed, if the
directors choose to ignore the major IOM recommendations, they will
hand opponents a devastating weapon, one that could be used to convince voters to reject
any proposal for continued funding. The board
would also give private investors more major reasons to say no to
CIRM pitches for cash.
Under Klein's leadership, the 29-member
board has rejected similar proposals for changes in the past. When
the IOM presented the study to the board just last month, the
reception was not much different. Several board members bristled. One
influential board member, Sherry Lansing, chair of the University of
California board of regents, said the directors' “hands are tied”
because some of the recommendations might require a vote of the people. Her comments echoed similar statements from Klein in 2009,
when he said board members would violate their oath of office if they
supported recommendations for changes that he opposed.
The IOM discussion in December,
however, was relatively brief and less than definitive. Klein has
been off the board since June 2011, replaced by Los Angeles bond
financier Jonathan Thomas, who is regarded as a welcome change by a
number of board members.
Nonetheless, the recommendations of the IOM could mean that some members of the board would lose their seats; others would lose important roles in the grant-award process or
within the agency itself. Conflict of interest rules would be
tightened. In some ways, the board would lose power, which would be
shifted to the president. The board would no longer vote on
individual applications – only a slate recommended by reviewers.
Applicants for CIRM awards would be directly affected, being barred
from making the sort of direct and public appeals that clogged the
CIRM board meetings last year. And that would be just the beginning.
Thomas, the CIRM chairman, is expected
to make his recommendations for action on the report, although they
have not yet been posted on the CIRM web site. Under what might be considered “normal” leadership, Thomas would be testing sentiment
among board members via personal conversations and phone calls.
However, in California that would be illegal – a violation of open
meeting laws that bar what are called “serial meetings” at nearly
all public agencies.
Thomas' task is not easy. Rounding up a
majority vote for anything significant among 29 strong-minded
individuals is not simple. But it is even more difficult when facing
a board that has a tradition of consensus management and
oversight.
The site of next week's meetings is
interesting. The nearly 100-year-old, iconic Claremont hotel has a
troubled financial history. It was up for sale for $80 million last
spring but there were no takers. In the early 20th century, the
property on which it is located was lost and won in a checkers game
in Oakland, or so the story goes.
The stakes are also high for the
California stem cell agency. Moves next week by directors could
easily determine whether CIRM becomes nothing more than an
interesting scientific footnote or establishes a path that will lead
it to long-lasting leadership in regenerative medicine.
Labels:
bond election,
cirm financing,
cirm future,
IOM
Friday, January 11, 2013
Nature Biotechnology: California Stem Cell Agency Receives 'Stinging Rebuke'
The headline this week in Nature
Biotechnology read: “IOM smacks down California Institute of
Regenerative Medicine.”
The story by Senior Editor Laura
DeFrancesco said that the $3 billion California stem cell agency
“received a stinging rebuke of much of the way it has been carrying
out its business by a group of independent reviewers.”
At the same time, DeFranesco wrote that
the blue-ribbon, Institute of Medicine panel “praised the courage
and vision of the individuals who spearheaded the program as well as
those toiling in the CIRM office in San Francisco.”
The Nature Biotechnology piece covered
familiar ground for many readers, summarizing the IOM's sweepingrecommendations last month, including those dealing with the built-in
conflicts of interest on the agency's 29-member governing board.
DeFrancesco wrote that is unclear
whether the agency will move to adopt any of the recommendations from
the panel, many of which have been rejected in the past.
Some members of the CIRM governing
board last month bristled at some of the recommendations. The board is scheduled to discuss the IOM report, for
which it paid $700,000, at a public meeting Jan. 23 in Berkeley.
Patient advocates are already organizing a turn-out to lobby against
some recommendations.
Friday, December 21, 2012
San Diego Newspaper Calls for Major Changes at California Stem Cell Agency
The San Diego U-T today ran an
editorial that was headlined “Stem cell research institute must fix itself.”
The editorial was written in response
to findings by the Institute of Medicine that the $3 billion
California stem cell should make sweeping changes to deal with issues
ranging from conflicts of interest to management structure.
The San Diego U-T editorial came as part of
a unanimous reaction so far from California newspapers.
The San Diego paper said,
“We hope we are wrong in thinking that, given the number of times the same criticisms of CIRM have come up over the past seven years, the agency doesn’t really take them seriously.
“If that is the agency’s attitude, it could well be a fatal error. CIRM has enough money remaining from the original $3 billion to continue awarding research grants for another four years. But it will either have to go back to California voters in 2014 or 2016 for another bond issue to continue its operations or find a different source of funding.
“Whichever CIRM decides, whoever is asked to foot the bill, either taxpayers or the private sector will demand transparency and accountability. We hope CIRM can demonstrate it.”
Boxing in the California Stem Cell Board
Robert Klein is much admired for his
prodigious efforts on behalf of stem cell research, including his
service as the first chairman of the $3 billion California stem cell
agency.
Klein was adept at many tasks, such as
directing the ballot campaign that resulted in passage of Proposition
71 in 2004 and creation of of the agency. One of Klein's less
publicly recognized skills was putting the governing board of the
agency in a box from time to time.
The 29 members of that board could well
be headed for another box – this time in connection with their
position on the Institute of Medicine's sweeping recommendations for major changes at the stem cell agency.
Here is how that could work based on a
similar situation in 2009 involving Klein and the Little Hoover
Commission, the state's good government agency.
Klein did not welcome the inquiry by
the commission, which was requested by state lawmakers who had butted
heads with Klein. He knew that the commission would come up with
recommendations that he would find odious.
So even before the Hoover report was
released in its final form, Klein had the board's outside counsel,
James Harrison, prepare a legal memo on a draft version of the study.
Harrison's memo said many of the most far-reaching recommendations of
the commission would require a vote of the people – a more costly
and unlikely proposition than a vote of the legislature.
Harrison's memo was dated June 23,
2009. The commission report was released June 26, 2009. On June 30, 2009, Klein warned directors in an email that support of some of the
proposals would violate their oath of office. The first time a
subcommittee of directors had to a chance to react publicly came on
July 16, 2009. The full board did not have the Hoover report on its
agenda until Aug. 6, 2009. By that time, they were thoroughly boxed
in.
Their choices were minimal, even if
they disagreed with Klein. To do anything other than go along with
him would mean rejection of a 10-page legal opinion from Harrison,
which could be interpreted as no-confidence vote on Harrison and
possibly Klein. Board members were not interested in losing
Harrison, who has been valuable asset to the board since day one.
Overthrowing Klein was even less likely in 2009.
Harrison is currently revisiting his
2009 memo in the wake of the Institute of Medicine recommendations,
which echo some of the major Hoover proposals. The board has also
scheduled a workshop for Jan. 23 that will discuss the IOM proposals.
If Harrison produces another legal memo
that is as explicit as the 2009 document, CIRM directors will have
few choices. The best procedure may well be for Harrison
to continue his work on the memo until after the Jan. 23 meeting.
Directors could then decide on initial steps in connection with the
IOM recommendations and ask Harrison how they can proceed legally, although the task is really more of a political challenge than a legal
one.
Directors paid $700,000 for the IOM's evaluation and advice. It is a prestigious body with virtually no critics in the scientific community. It would be odd, to say the least, for CIRM directors to now reject major recommendations from the blue-ribbon panel only because the proposals might require a statewide vote. The response is likely to be from some: Well, stem cell directors, let's have a statewide vote, and we expect you to support the IOM changes if you plan to seek additional state funding.
Placing another stem cell measure on the ballot -- with or without related additional funding for the agency -- would bring into play a host of issues, including possible elimination of the agency. Not to mention disturbing existing stakeholder relationships and raising uncertainty in the scientific and biotech business communities.
Directors believe the agency has made a major contribution both to California and to science. So does the IOM. The directors need to move forward on the IOM recommendations if they are to continue their research efforts beyond 2017, when cash for new grants runs out. And putting the board in a box is not the best way to give them the room they need to maneuver.
Labels:
cirm finances,
hoover,
IOM,
iom reaction,
klein
Wednesday, December 19, 2012
Exploring the Straw Man Argument Against IOM Reforms at California Stem Cell Agency
Constitutional objections to some of
the Institute of Medicine's sweeping recommendations for changes at
the $3 billion California stem cell agency amount to little more than
a straw man, at least based on a legal memo produced earlier by the
agency.
The legal objections to structural reforms at the
agency were initially advanced in 2009 when the stem cell agency was
fighting an unwelcome analysis of its activities by the state's good
government agency, the Little Hoover Commission. The objections were
voiced again at a meeting earlier this month by some governing board
members, particularly Sherry Lansing, who is also chairwoman of the
University of California regents. Her comments came within minutes of
the start of the Institute of Medicine's (IOM) presentation to the
board.
She said directors' hands “are tied”
because of requirements in Proposition 71, the ballot initiative that
created the stem cell agency, which is formally known as the
California Institute for Regenerative Medicine(CIRM). While Lansing
did not elaborate, some of the initiative is written into the state
constitution, which can only be amended by a vote of the people.
However, Proposition 71 can also be amended by a 70 percent vote of
each house of the Legislature and the signature of the governor,
which is no small task to achieve.
The 2009 legal memo (see the full text
below) dealt with the recommendations of the Little Hoover
Commission, some of which were cited and echoed by the IOM. The legal
memo contended that the legislature was barred from making major
changes in the structure of the stem cell agency governing board
because the changes supposedly would not “enhance the ability of
the (agency) to further the purposes of the grant and loan programs.”
The argument was that only the people could make “non-enhancing”
changes. The vague “enhancement” requirement was written into
Proposition 71 by its authors, one of whom is James Harrison, the
outside counsel to the board, who was also the lead author on the
2009 memo. Harrison is revisiting the supposed constitutional issues in the wake of the IOM study.
However, the objections cited in his earlier memo are dubious and easily overcome. The meaning of “enhance” is
so vague as to permit wide interpretations. Certainly, removing
public suspicion about conflicts of interest would seem to help move
the agency forward. Straightening out the muddled management
structure of the agency, with its overlapping responsibilities for
the chairman and president, would certainly seem to enhance the
functioning of the agency. Assuring that the governing board has the
full ability to exercise strong oversight over the conduct of the
agency would certainly seem to be an enhancement and long overdue.
At least that is what the most
prestigious body of its sort says. The Institute of Medicine studied
the agency for 17 months under a $700,000 contract with CIRM. The
IOM's charge was to evaluate the performance of the agency and make
recommendations for improvements. The IOM recommendations echoed
findings not only of the Little Hoover Commission, but some in two
earlier studies also funded by the agency.
For CIRM directors now to reject the
IOM findings and turn away would be to indicate that their earlier
admiration and respect for the IOM was something of a sham or, more
likely, now inconvenient.
As for removing ambiguity about what
does or does not enhance the agency's mission, the 29-member board
could simply adopt a resolution declaring that all the IOM
recommendations would enhance the CIRM mission.
One of major obstacles to acting on the
earlier recommendations for changes was Robert Klein, the first
chairman of the agency board. Klein, an attorney and real estate investment
banker, also directed the writing of Proposition 71 and wrote
portions of it himself. He would often make numerical code citations
to the initiative during agency board meetings.
Klein is now gone from the board,
leaving in 2011 at the end of his term. He was replaced by Jonathan
Thomas, a Los Angeles bond financier, who has ushered in a new and
different era at the stem cell agency. Some might say a more
reasonable era. He says he and governing board
take the IOM study seriously.
The report is scheduled for discussion
Jan. 23 at a public workshop at the Claremont Hotel in Berkeley, Ca.,
the day before the regular board meeting. .
The IOM's recommendations have won theeditorial endorsement of all the California newspapers that have so
far written about them. The newspapers believe that the proposals
would indeed enhance the agency's mission and are, in fact, necessary
if the agency is to survive beyond 2017, when the money for new
grants runs out.
Directors of the stem cell agency are
currently mulling the future of their efforts. If they are to be
successful in raising additional hundreds of millions of dollars –
be they private or public – the directors must confront the
findings of the IOM in a forthright manner. And they must move to
dispel the cloud that now hangs over the stem cell agency.
(Editor's note: The full text of the
2009 legal memo can be found below. Also below is another related
legal memo from Americans for Cures, a stem cell lobbying group
sponsored by Robert Klein at the same time he was chairman of the
stem cell agency. Despite the language on the Americans for Cures
memo, it is a public record. It became a public document when Klein
submitted it to the Little Hoover Commission.)
Labels:
IOM,
iom editorials,
littlehoover,
Prop. 71 difficulties
Tuesday, December 18, 2012
California Editorial Unamity: Stem Cell Agency Needs Revamp
With the addition of another editorial
this week, reaction among California newspapers so far has been
unanimous that the $3 billion California stem cell agency should heed
the sweeping recommendations of the prestigious Institute of
Medicine.
The Riverside Press-Enterprise added its voice yesterday, declaring,
“Good intentions do not justify poor practice.”
Like others, the newspaper said that
the agency “needs to revamp its governance structure to avoid
potential conflicts of interest and boost public confidence in the
agency.”
The Riverside paper focused on the conflicts of interest at the organization, which has seen about
90 percent of its funding go to institutions with ties to directors, but also supported other recommendations, including elimination of the dual executive arrangement at the research effort.
The editorial said,
“An agency spending Californians’ money has no business being cavalier about good government practice and ethical safeguards — no matter how promising the potential therapies might be. The stem-cell institute is not a private fiefdom, but a taxpayer-supported undertaking. Yet many on the stem-cell institute’s board objected this month to the report’s recommendations.
“The agency also said that Prop. 71’s provisions mean that enacting many of the proposed fixes would require either a supermajority vote of the Legislature or another ballot measure. That prospect should warn Californians about the dangers of voting for complex, costly, politically driven initiatives that have little to do with fundamental state duties.
“Still, the stem-cell agency cannot just sit on these recommendations without damaging its credibility. The search for medical breakthroughs does not justify ignoring vital safeguards for spending taxpayer dollars.”For a look at other editorials, see here and here.
Labels:
conflicts,
IOM,
iom editorials,
iom reaction,
Prop. 71 difficulties
Sunday, December 16, 2012
Southern California Newspaper Tackles Stem Cell Agency and UC Irvine Grants
The Orange County Register today zeroed
in on the $3 billion California stem cell agency and its relationship
to the local University of California campus in the wake of sweeping
recommendations for changes at the eight-year-old agency.
The article by Melody Petersen was
headlined “Ties to stem cell board lucrative.”
Petersen began her article with story of the $20 million award to StemCells, Inc., earlier this year and
the firm's partnership with Frank LaFerla of UC Irvine, which is located in Orange County.
The award was rejected twice by
reviewers at the stem cell agency but the governing board of the
agency (CIRM) approved it on a 7-5 vote in September following
lobbying on behalf of the company by the board's former chairman,
Robert Klein, and others.
Petersen said the award was not the first time that questions have been raised about stem cell agency grants. She said that the 17-month study by the prestigious Institute of
Medicine (IOM) and some of its findings, particularly those dealing
with conflicts of interest, echoed criticisms that have been raised for years.
She wrote,
“Repeated independent reviews of the agency, including one by the (IOM) released this month, have found that its board is rife with conflicts of interest. In fact, of the $1.7 billion that the agency has awarded so far, about 90 percent has gone to research institutions with ties to people sitting on the board, according to an analysis by David Jensen at the California Stem Cell Report, which closely follows the agency's operations.
While the agency has yet to produce a
cure, Petersen said,
“What's clear already is that the money has transformed stem cell research in California and poured hundreds of millions of dollars into the state's universities, including UC Irvine.”
She noted that the CIRM governing board
is dominated by members from the UC system, including two professors
at UC Irvine.
Peterson continued,
“Before Proposition 71 (the measure that created the agency) passed, UC Irvine had less than ten stem cell scientists, who received about $1.5 million in funding each year. Now, after receiving $100 million in grants from the state agency, the university has sixty scientists working to advance stem cell research and teaching. It touts itself as one of the top stem cell research centers in the world. In 2010, it opened an $80 million four-story stem cell research center with the agency picking up $27 million of the cost.
“As UC Irvine has won increasing amounts of taxpayer money, its two professors who sit on the agency's board have risen in status on campus.
Susan Bryant
UC Irvine photo
“Professor Susan Bryant, an expert in regenerative medicine, was dean of the School of Biological Sciences when she was named to the agency's board in 2004. She was then promoted to vice-chancellor of research. In July, she was named the university's interim executive vice-chancellor and provost, its second most powerful administrator.
“When Professor Oswald Steward, a stem cell scientist, joined the agency's board in 2004, he was director of UCI's Reeve-Irvine Research Center for Spinal Injury. Since then, the scientists working in his center have received millions of dollars in grants from the agency. In May, the university rewarded Steward with an additional title: senior associate dean of research for the School of Medicine.”
“The two professors are prohibited from receiving any agency funds for their own scientific work. But so much money has been funneled into the stem cell field in California that it can be difficult to show their continued scientific efforts are not somehow benefiting. For example, Bryant co-authored a scientific article in 2009 with nine other scientists about the genetics of salamanders, which can regenerate limbs. In the report, the group recognized the state agency for partially funding their work. Bryant said that the money was received by another scientist in the group who was not employed by UC Irvine. She said the state agency has never given a grant for research involving salamanders. 'I have never-ever benefited from CIRM funding,' Bryant said using the agency's acronym.
Os Steward
UC Irvine photo
“Steward said he stopped his stem cell research when he joined the board in 2004. His board position, he said, 'has prevented me from taking on lines of research I otherwise would do.'
“Tom Vasich, a campus spokesperson, said Bryant and Stewart's positions on the agency's board played no part in their promotions and success at the school.”
Petersen additionally reported that
Steward and Bryant are not allowed to vote on grants to UC Irvine.
Petersen pointed out that the
University of California has 16 members on the 29-member board. One
of those is the chairwoman of the UC Regents, Sherry Lansing.
Petersen also noted that three of the UC officials, including
Steward, hold seats on the board as patient advocates.
Petersen is a recent addition to the
Register's staff, joining it in November as an investigative
reporter. She worked as a business reporter for the New York Times and authored "Our Daily Meds," a book about the pharmaceutical industry. She shared in the top award in newspaper financial journalism when she was at the San Jose Mercury News.
Labels:
conflicts,
Grant-making,
ICOC,
IOM,
iom reaction,
media coverage
Friday, December 14, 2012
Two More Editorials: The California Stem Cell Agency Should Heed IOM Recommendations for Reform
Two other major California newspapers
today said the $3 billion California stem cell agency needs to “clean
up its act” if it wants to be successful in continuing its efforts
at turning stem cells into cures.
The editorials appeared in the Los Angeles
Times, the state's largest circulation newspaper at more than
700,000, and the San Jose Mercury News in California's Silicon Valley.
The Mercury News has a reported circulation of nearly 600,000,
although that figure includes other Bay Area newspaper owned by the
same chain.
Both editorials focused on the 17-month evaluation of the agency by the prestigious Institute of Medicine (IOM) as did earlier editorials in The Sacramento Bee and the San Francisco Chronicle. The IOM recommended sweeping reforms at the agency that would alter its structure and target conflicts of interest.
“The $700,000 spent on the study...will be wasted if the institute's oversight board fails to heed the (IOM) committee's criticisms, which echo the findings of the Little Hoover Commission and other groups over the years.”
The editorial continued,
“The 29-member board is made up almost entirely of representatives of advocacy groups and research institutions that have a direct interest in how the money is spent.”
The Times cited the California Stem
Cell Report's calculations that about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions linked to current and former members of its governing board.
The Times noted an award to a Northern California firm that has stirred some criticism. The editorial said,
“The board also overrode the advice of its scientific advisors — twice on a single application when it considered a grant for a well-connected company, StemCells Inc. based in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71, which created and funded the agency in 2004, and its former head, lobbied so intensively for the company that one board member described it as 'arm-twisting.'"
The Times concluded,
“The agency has used more than half of its funding and one day will almost certainly want to ask taxpayers for more. It should remember that voters will look for evidence of public accountability as well as respected research.”
The San Jose paper sounded a similar
note about the agency. Its editorial said,
“(I)f it wants to survive...it should heed the Institute of Medicine's advice to eliminate conflicts of interest on its board -- and do it before awarding the remaining $1.2 billion of the $3 billion voters approved for stem cell research.”
But the paper said the stem cell agency
should not be provided any more state funding.
“Long-term funding was never the intent when Proposition 71 passed in 2004. It was supposed to kick-start research at a time when federal funding was blocked and to establish California as a major player in the rapidly advancing medical field.
“The agency could continue to bring value to the state as an advocate and funder of research, but only if it can attract private donors, partners and investors. For that to happen, it will need a board that passes the ethics test, with more independent experts and industry executives free of conflicts.
“At the outset, stem cell advocates took immense pride in structuring the agency to keep it relatively free of legislative interference despite the use of public money. Politicians kept their hands off, which was good. But the agency created its own inappropriate influences in the way it constituted its board. Now it needs to clean up its act.“
Thursday, December 13, 2012
Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting
Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).
Only two pieces appeared, one in the
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
One of the recommendations of the IOM
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
Fikes wrote,
"'I'm a colon cancer survivor,' said Art Torres, vice chairman of the oversight committee, and a patient advocate designate. 'Does having colon cancer make me biased?'
“Jeff Sheehy, another patient advocate designate, protested what he called a 'defenestration' of patient advocates, whose interests often span multiple diseases.”
Ron Leuty of the San Francisco Business
Times skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Fikes also had a piece on ViaCyte,
which is in his area, receiving another $3 million from CIRM.
Subscribe to:
Posts (Atom)