Here is the text of the initial
response from Robert Klein, chairman of the California stem
cell agency until July 2011, to questions from the California Stem Cell Report (CSCR)
concerning his $21,630 donation to the agency. The questions posed by
CSCR on precede the response by Klein. Here is a link to a story on
the matter.
CSCR to Klein:
“Why did you give the agency the
money?
“Did you place on conditions on its
use?
“Did anyone connected with the agency
indicate in advance that your donation would be desired? If so
who? Who did you deal with primarily on the donation -- Trounson,
Thomas or...?
“The donation came one month after
grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do
you think it was appropriate to make the donation and then ask the
board twice to override its reviewers?
“Do you think the donation and
subsequent action on StemCells, Inc.'s Alzheimer's application will
negatively color the perception of future efforts by CIRM at private
fundraising?”
Klein's response:
“In April or May of 2012 I committed
approximately $20,000 as a contribution to CIRM to cover the travel
expenses of staff to the International Stem Cell Society
meeting in Japan. My commitment to ensure scientific staff can
participate in international meetings dates back many years. In 2011
I wrote the following explanation of its importance in obtaining the
knowledge to accelerate the drive of scientific research to reach
patients with chronic disease.
approximately $20,000 as a contribution to CIRM to cover the travel
expenses of staff to the International Stem Cell Society
meeting in Japan. My commitment to ensure scientific staff can
participate in international meetings dates back many years. In 2011
I wrote the following explanation of its importance in obtaining the
knowledge to accelerate the drive of scientific research to reach
patients with chronic disease.
Leverage
Leading Edge Science
Leading Edge Science
“Travel by CIRM staff members and leadership permits CIRM to stay
in contact with, and understand, the leading edge advances of
scientists all over the world, and to leverage those advances by
creating a platform for collaborations between these leading
scientists and their peers in California. Currently, CIRM has
collaboration agreements with 15 foreign governments pursuant to
which these governments have pledged $134,380,000 in commitments to
fund the work of their scientists on join teams with California
scientists to develop therapy candidates and to advance therapies to
human trials. Although a significant amount of this commitment is
currently pending scientific peer review and not all of it will be
awarded as part of a successful application, every dollar in
funding by a foreign government magnifies the scientific impact of
California’s taxpayer dollars. If just $40 million is awarded each
year over ten years, it would provide California with $400 million of
scientific leverage.
- It
is critical to understand that there are unpublished scientific
discoveries in progress in each of these nations. Often, publication
may trail a scientific discovery by nine months or more. - The
travel requested by CIRM provides a critical link for the timely
transmission of valuable new information. California cannot afford to
lose the opportunity to harness discoveries in other countries to
advance the development of therapies in California and to capture the
opportunity to advance therapies for patients instead of using
California taxpayer dollars to duplicate discoveries already mastered
in other countries. - While
CIRM’s scientific staff works with scientists in other countries to
capture the scientific knowledge for the benefit of California’s
therapy development teams, the Chairman’s Office works with
international finance ministers, the premiers of international
states, and foreign funding agencies to ensure funding allocations
for these bilateral funding agreements. These discussions often
involve face-to-face negotiations in foreign nations and states, in
addition to meetings at international conferences, all of which are
supported by extensive staff work in California. - CIRM
issued its first co-funding awards early in 2009. Over the last two
years, these agreements have yielded $57 million in international
funds actually approved through peer review. This $57 million
represents participation by only the first five countries and one
international state with which CIRM established a collaboration. Now,
CIRM has agreements with nine countries and two international states
and an additional three countries will be added in the near future. - Even
if CIRM were only to obtain $30 million per year in international
matching funds, the ratio of return on CIRM’s $206,920 travel
expenditures would be approximately 145 to 1. - Proposition 71 specifically anticipated
and directs CIRM to develop leverage and global leadership to capture
the benefit for patients.
Keeping on the Cutting Edge of Stem
Cell Science
Cell Science
"CIRM’s over 20 MDs and/or PhDs
science officers on the grant review staff at CIRM reach out
nationally and internationally through conferences that may include
10-20 meetings per day and workshops of 8-12 hours per day to grasp
the leading edge of this pre-publication, dynamic
revolution in medical knowledge. In order to ensure that the
every research dollar is optimally deployed to advance therapies to
save lives or rescue the quality of life for patients, it is critical
that CIRM staff remain on the cutting edge of new discoveries.
International conferences and workshops provide a critical
opportunity for massive and decisive transfers of information, which
ensures that California is funding the right research.
science officers on the grant review staff at CIRM reach out
nationally and internationally through conferences that may include
10-20 meetings per day and workshops of 8-12 hours per day to grasp
the leading edge of this pre-publication, dynamic
revolution in medical knowledge. In order to ensure that the
every research dollar is optimally deployed to advance therapies to
save lives or rescue the quality of life for patients, it is critical
that CIRM staff remain on the cutting edge of new discoveries.
International conferences and workshops provide a critical
opportunity for massive and decisive transfers of information, which
ensures that California is funding the right research.
“I principally corresponded with Dr.
Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection
of scientific staff. In May and even in June when the conference
occurred I had no idea that there would be any disagreement on the
Alzheimer’s application of Stem Cells Inc. in August. At the Board
meeting I asked that there be consideration for the fact that three
other peer reviews had found the work leading up to this application
to be outstanding and they had ranked it highly. In addition, the
current peer review had not been briefed on the fact that they
downgraded the applicant for following the directions on material
points by the prior peer reviews. Finally, the standard deviation on
the 2012 peer review was extremely high and the re-review by the
three member committee resulted in a split decision. It is
particularly appropriate with a huge standard deviation,
demonstrating both strong support and opposition within the peer
review group, for the Board to make its own independent decision.
Please recall that the staff recommended against approval so that
they clearly were not influenced by my commitment to a contribution
to the Agency, months before, for the benefit of scientific staff to
be able to attend an international science conference. Additionally,
Dr. Trounson, I believe, recused himself from the review of the Stem
Cells Inc. application, for unrelated reasons, so he was not
involved. I personally had served on the three prior peer reviews,
including one in the prior year that recommended this application for
a Disease Team approval. I know how strongly the scientists on those
three prior peer reviews supported funding this scientific research,
with the 2011 review specifically recommending this Disease Team for
approval. I believe it was extremely important for me to provide a
voice to those three scientific panels who disagreed with a portion
of the scientists on the 2012 scientific panel. Supporting the
scientific movement to human trials for Alzheimer’s has to be
eventually approved by the FDA; but, this loan will move the science
and the potential for clinical trials forward significantly and
hopefully obtain FDA approval. I believe all three of the Board’s
overrides of the peer review recommendations on the Disease Team
round in 2008 are leading directly to human trials in the United
States and/or United Kingdom. 92% of the all of the funds awarded by
CIRM have followed the recommendations of the peer review committee;
but, in those significant cases where the Board has made an
independent decision, there has been an extremely high success rate
particularly when there has been a high level of disagreement within
the Peer Review Board that was overridden and prior peer reviews
recommended and/or approved the scientific approach and concepts of
the applicant.”
Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection
of scientific staff. In May and even in June when the conference
occurred I had no idea that there would be any disagreement on the
Alzheimer’s application of Stem Cells Inc. in August. At the Board
meeting I asked that there be consideration for the fact that three
other peer reviews had found the work leading up to this application
to be outstanding and they had ranked it highly. In addition, the
current peer review had not been briefed on the fact that they
downgraded the applicant for following the directions on material
points by the prior peer reviews. Finally, the standard deviation on
the 2012 peer review was extremely high and the re-review by the
three member committee resulted in a split decision. It is
particularly appropriate with a huge standard deviation,
demonstrating both strong support and opposition within the peer
review group, for the Board to make its own independent decision.
Please recall that the staff recommended against approval so that
they clearly were not influenced by my commitment to a contribution
to the Agency, months before, for the benefit of scientific staff to
be able to attend an international science conference. Additionally,
Dr. Trounson, I believe, recused himself from the review of the Stem
Cells Inc. application, for unrelated reasons, so he was not
involved. I personally had served on the three prior peer reviews,
including one in the prior year that recommended this application for
a Disease Team approval. I know how strongly the scientists on those
three prior peer reviews supported funding this scientific research,
with the 2011 review specifically recommending this Disease Team for
approval. I believe it was extremely important for me to provide a
voice to those three scientific panels who disagreed with a portion
of the scientists on the 2012 scientific panel. Supporting the
scientific movement to human trials for Alzheimer’s has to be
eventually approved by the FDA; but, this loan will move the science
and the potential for clinical trials forward significantly and
hopefully obtain FDA approval. I believe all three of the Board’s
overrides of the peer review recommendations on the Disease Team
round in 2008 are leading directly to human trials in the United
States and/or United Kingdom. 92% of the all of the funds awarded by
CIRM have followed the recommendations of the peer review committee;
but, in those significant cases where the Board has made an
independent decision, there has been an extremely high success rate
particularly when there has been a high level of disagreement within
the Peer Review Board that was overridden and prior peer reviews
recommended and/or approved the scientific approach and concepts of
the applicant.”
(Editor's note: The applications in this round were reviewed once in April 2012 by CIRM's full grant review group. StemCells, Inc.'s application was subject to a reevaluation after Klein's appeal in July 2012 and rejected again, but it was not a full review. Klein may be referring also an earlier round that provided grants for planning to apply for the full $20 million.)
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