A Patent War on iPS: One Researcher’s View
By Dr. Matthew Watson
As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,
“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.
“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results.
“A search for “cellular
reprogramming produced more than 1,000
results.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..
“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.
“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?
“I don’t think so.
“This could get really messy.”
Patient Advocate Reed Defends Klein Donation to Stem Cell Agency
By Dr. Matthew Watson
received the following email from Don Reed, a patient advocate, who
has long been involved in California stem cell agency affairs. Reed
is vice president of public policy for Americans for Cures
Foundation, a position he has held for some years. Americans for
Cures is the personal lobbying organization created by Robert Klein,
former chairman of the California stem cell agency. Reed said his
opinions below are his own and may or may not reflect those of the
foundation.
“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.
“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives. The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.
“Unfortunately,
your article appears to imply corrupt motivations.
“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?' The article
states that 'Klein wanted to meet with the six science officers…'
and to get their impressions on the conference.
“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.
“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.
“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability to recognize her own son.
I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration. Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.
“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?
“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.
“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.
“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”
WARF hESC Patent Update: Seven Years and Challenge Still Underway
By Dr. Matthew Watson
Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation) patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
“Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds.
“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents. Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.
“This is Dan's summary of the current
situation:
"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology."
“The 'narrowing' of the patents has
had an unexpected consequence. Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”
which also involved an interesting discussion of IPS research,
Loring said,
“Patents
on fundamental things --
genes, human embryonic stem cells, iPS cells --
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.
“Patents
are supposed to stimulate investment in development. Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?
“But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells. One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.
“There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs. I’m paying attention to the patent 'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves. It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”
SUNY Fredonia Lists 2013 Graduates – Jamestown Post Journal
By Dr. Matthew Watson
SUNY Fredonia Lists 2013 Graduates Jamestown Post Journal ... Bachelor of Science, Social Work; Megan E. Gardner, Bachelor of Science, Social Work; Diala I. Ghazal, Bachelor of Science, Molecular Genetics; Lisa D. Heintzelman, Master of Science, Speech-Language Pathology; Cory P. Hunter, Bachelor of Science, ... |
Dr. Tom Reh on Stem Cell Therapy – Video
By JoanneRUSSELL25
Dr. Tom Reh on Stem Cell Therapy
http://www.fightblindness.org | Thomas Reh, Ph.D, of the University of Washington, discusses how stem cell therapy, a term for using stem cells to treat and prevent...
By: FndFightingBlindness
View post:
Dr. Tom Reh on Stem Cell Therapy - Video
Dr. David Gamm on Stem Cell Therapy – Video
By daniellenierenberg
Dr. David Gamm on Stem Cell Therapy
http://www.fightblindness.org | David Gamm, M.D., Ph.D., of the University of Wisconsin Eye Research Institute, discusses how stem cell therapy, a term for using st...
By: FndFightingBlindness
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Dr. David Gamm on Stem Cell Therapy - Video
Stem cell therapy PRP lip rejuvenation – Video
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Stem cell therapy PRP lip rejuvenation
stem cell therapy.
By: dralansari2010
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Stem cell therapy PRP lip rejuvenation - Video
Two approaches to stem cell therapy for osteoarthritis – Video
By raymumme
Two approaches to stem cell therapy for osteoarthritis
http://www.stemcellsarthritistreatment.com There are two potential approaches of stem cell-based cartilage repair and regeneration. The first is ex vivo cart...
By: Nathan Wei
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By: Anupama Karthikeyane
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Kilian Before
By NEVAGiles23
Kilian Before After Stemlogix Stem Cell Therapy
By: Jim Cain
Here is the original post:
Kilian Before
Problems With Genetic Engineering & Genetically Modified Organisms (A Basic … – Infoshop News
By Dr. Matthew Watson
![]() FoodNavigator-USA.com | Problems With Genetic Engineering & Genetically Modified Organisms (A Basic ... Infoshop News Unfortunately, many people still do not understand the issues relating to genetic engineering and the products of that process. The ignorance surrounding this subject can largely be credited to the PR efforts of corporate agribusiness. These PR efforts ... Can eating chocolate be a political statement?Nashua Telegraph Letter of the Day: Labeling costsSanta Rosa Press Democrat GMO labeling advances; session winds downBrattleboro Reformer vtdigger.org -Vermont Public Radio -FoodNavigator-USA.com all 25 news articles » |
Cash and Favors: Robert Klein Gives $21,630 to the California Stem Cell Agency
By Dr. Matthew Watson
A seemingly innocuous $21,630 gift to
the California stem cell agency has kicked up new questions about a
controversial $20 million research award and generated a wave of
special favors for the donor that stretched out to include a gold
mining multimillionaire from Canada.
![]() |
Robert Klein Elie Dolgin/Nature photo |
The gift was made last May by Robert
Klein, chairman of the stem cell agency from 2004 to July 2011, but has never
been publicly reported to the agency's governing board as required by
its own regulations.
reviewers of a $20 million application by StemCells, Inc., of Newark, Ca. The board subsequently asked for a reevaluation of the proposal, which was again rejected by reviewers. Klein persisted at a September meeting, and the 29-member board decided, on a 7-5 vote, to go along with him. It was the
first time in its eight-year history that the board has approved an
application that was rejected twice by its scientific reviewers, who scored the proposal at 61 out of 100.
Klein's donation triggered a number of
special favors from the agency, according to documents provided by CIRM to the California Stem Cell Report under a state Public Records Act request. Klein wanted to meet with the six science officers, who have a wide range of responsibilities, including managing and developing grant and loan programs, participating in reviews of applications and evaluating research progress. CIRM President Alan Trounson obliged. At the meeting in Japan, the six science officers received a memo approved by Trounson instructing them to meet
privately “one-on-one” with their benefactor and to give him special access to their activities. The meetings were
actually scheduled to also include a third person, Rob McEwen, who is one of the 100 richest persons in Canada, a $20 million donor to a stem
cell center in Toronto and CEO of the gold mining company bearing his name.
The memo indicated
that the science officers – all California state employees –
should be helpful by identifying areas of “special importance” to
Klein and “other donors.” The CIRM documents show no objection
from the agency to instructions from another member of the public --
Klein aide Melissa King -- to provide her and Klein with written
summaries about the science officers' activities at the convention
along with “details” about their work at CIRM. Email addresses of
the six were also provided to Klein, who may have additionally
received their cell phone numbers although that is not entirely
clear.
invited McEwen to a closed-door session in Japan involving the
agency's international partners, a session at which presumably
valuable, little known scientific information might be mentioned and
future directions charted. Trounson specifically told McEwen in an
email that it was Klein who asked that the executive be invited to the
session.
wrongdoing in connection with the donation, which was the only
private contribution to CIRM in the 2011-12 fiscal year. Both say
there was no connection between the donation last May 16 and the
StemCells, Inc., application, which was rejected by reviewers one
month earlier during closed-door meetings April 18-20, 2012.
from persons who have applied for funding or who intend to apply for
funding, but the rules do not speak to gifts from persons who lobby
on behalf of funding for others. The rules require that the governing
board of the agency be informed at a public meeting of gifts accepted
by Trounson on behalf of CIRM. Trounson is required to identify the
donor and conditions imposed by acceptance of the gift. Trounson did
neither prior to Klein's appearance last July on behalf of StemCells,
Inc.
recused himself from public discussions of the StemCells, Inc.,
application, although he did not offer an explanation. However, his
action was connected to his relationship with stem cell scientist Irv Weissman of
Stanford University, who founded the publicly traded company, currently sits on its board
and holds 124,608 shares of the firm. Trounson was a guest once at
Weissman's ranch for four days in July 2011, CIRM said in response to
a question this week.
for public communications, said last week that the agency plans to
report the donation to the governing board at its meeting in
the San Francisco Bay Area later this month.
the donation prior to the board's consideration of StemCells, Inc.'s,
application was “due to the lack of additional donations, a
transition in CIRM’s finance office and an oversight."(See thefull text of McCormack's statement here.)
the agency is concerned about the appearance of Klein's donation and
the subsequent board action, McCormack replied,
“No, the two items are entirely
separate with no connection. Item 1 involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research. The science officers had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend. Item 2 is an ICOC (board) decision to fund
a research project that they felt had promise and was important for
the people of California.”
in the wake of his donation, the agency did not respond to inquiries
asking for an explanation.
an email that his donation was not connected to StemCells, Inc. He said that as late as June he had “no idea”
that the its application had been rejected by reviewers. Klein said that he committed to the donation
in “April or May.” (The full text of Klein's comments re the application can be found here and here.)
Prior to leaving CIRM in 2011, Klein was a non-voting member of the CIRM grant review committee, which consists of out-of-state scientists and seven CIRM board members. His service on the committee included the period when it approved a planning grant for StemCells, Inc., to prepare its application for the $20 million.
Klein noted that he did not pick the six science officers for the Japan trip. One of them was the lead science officer on the award round involving StemCells, Inc. A second was also heavily involved, according to the transcript of the July 2012 board meeting. Science officers, however, do not vote on or score applications. Klein characterized the CIRM staff as recommending against approval of the grant so “they were clearly not influenced” by his donation.
science officers were aimed at determining whether they believed the
cost of attending the stem cell convention justified what they
learned at the meeting. He said a second goal was to aid universities
and other researchers, mainly in Canada, “in advancing their
contributions from an existing donor or donors.” Canada is one of
CIRM's research partners.
Klein defended the involvement of
McEwen, who Klein said has contributed to the stem cell group conducting the meeting. Klein said McEwen does not engage in technical
discussions and added,
“On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual.”
employees has stirred up controversy over the years in California.
The most recent example was Gov. Jerry Brown's much-reported trip to
China this spring, which was financed by private donations. Articles
in the Los Angeles Times and The Sacramento Bee both noted that
private funding arrangements have plenty of critics.
wrote,
“It just looks unseemly — a pack of lobbyists and other
favor-seekers paying big bucks to traipse after the governor,
schmoozing and gaining invaluable access.”
from Jock
O'Connell, international trade adviser for the economics
consulting firm Beacon Economics, who said,
“They're donating because they want
to curry favor with the incumbent administration."
donations for trips in the future, McCormack replied that the agency
is “always open to donations from generous supporters” provided
they meet the state's legal requirements.
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FefPhO0IEiY/cash-and-favors-robert-klein-gives.html
The Klein Donation: Text of Stem Cell Agency’s Key Responses
By Dr. Matthew Watson
Here is the text of the key comments
from the California stem cell agency in response to questions from
the California Stem Cell Report (CSCR) concerning the $21,630
contribution by Robert Klein. Here is a link to the full story on the matter.
“Is CIRM concerned about the
appearance created by the donation from Bob Klein to enable scientific
staff to attend the ISSCR meeting in Yokohoma, coming one
month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application
and one month before the July Board meeting that led to the approval
of the award?”(Editor's note: It was actually two months before the board meeting.)
“No, the two items are entirely
separate with no connection. Item 1 involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research. The science officers
had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend. Item 2 is an ICOC decision to fund a
research project that they felt had promise and was important for the
people of California.”
could not finance the trip itself ."
Governor's Office issued an Executive Order requiring state agencies,
under the Governor's direct authority, to reduce out-of-state travel.
Although CIRM was not required to participate, we nevertheless
imposed restrictions on out-of-state travel to meet the intent/spirit
of the Governor's request. Accordingly, we made a decision to
reduce the number of our science staff who would be attending the
conference. Bob Klein's donation made it possible
for those staff to go."
failure to report the Klein donation to the board as required by
agency rules.
“Under the Gift Policy, the President
had the authority to accept Mr. Klein’s generous offer as a 'Direct
payment or reimbursement by third parties for the costs of general
operation or grant management administrative activities.' (Gift
Policy, Sec. III(A)(2).) Because CIRM receives gifts only
infrequently, CIRM staff determined that it would be more efficient
to report gifts to the Board on a semi-annual basis. Mr.
Klein’s donation was the first gift CIRM had received in some
years. Due to the lack of additional donations, a transition in
CIRM’s finance office, and an oversight, CIRM staff has not yet
presented a report including Mr. Klein’s gift. Staff plans to
report Mr. Klein’s gift as part of the finance report at the May
Board meeting. Because the President had the authority to
accept the gift pursuant to section III(A)(2) of the Gift Policy, it
did not require a commitment letter. (See Gift Policy, Sec.
III(C)(1) ['A Commitment Letter is not required for gifts described
under III.A.2., 3. and 4.'].) However, consistent with the
policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy
of which we have already provided you.”
The Klein Donation: Text of Robert Klein’s Response re StemCells, Inc.
By Dr. Matthew Watson
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.
“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?”
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.
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.
Cell Science
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.
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.)
The Klein Donation: Text of Robert Klein’s Comments on Special Treatment by CIRM
By Dr. Matthew Watson
Here is the text of comments from
Robert Klein, former chairman of the California stem cell agency,
concerning his $21,630 donation to the agency and subsequent actions
by the agency. Klein's comments May 1 came in response to questions
from the California Stem Cell Report(CSCR) on April 30. The text of
the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.
"I have sent the following to CIRM
asking for their response and am offering the same opportunity to
you. Here is what I sent the agency:
'The documents that I have received so
far show that after Klein gave CIRM $21,000 the agency instructed six
of its science officers to give him special access to their
activities and apparently did not object to additional instructions
from another member of the public, Melissa King, to provide Klein and
her with written summaries about their activities at the ISSCR
convention and “details” about their work at CIRM. Email
addresses of the six were also provided to Klein, who may have
additionally received their cell phone numbers although that is not
entirely clear. The CIRM documents show that the six were told to
engage in one-on-one sessions with Klein, which actually included a
third person, a wealthy Canadian mining company executive. One
document indicates that the science officers should assist in
fundraising for CIRM by identifying areas of “special importance”
to Klein and 'other donors.'
"'Additionally, Alan Trounson, at
Klein's request, invited the mining executive to a closed door
session involving the agency's international partners, a session at
which presumably valuable, little known scientific information would
be discussed and future directions charted. Trounson specifically
told the executive that it was Klein who asked that executive be
invited to the session, adding to Klein's clout in any business or
other dealings that Klein might have with the executive.'
My questions to CIRM deal with the
special treatment that was provided in connection with your donation.
I would ask you if you think that state agencies should provide this
sort of extraordinary treatment for individuals who donate to the
agency. At the very least, doesn't this raise questions about the
integrity of the agency and doubts in the public mind about whether
it can be fair and even-handed in its activities?
"In April or May of 2012 I committed
to contribute a charitable donation to CIRM to cover the travel costs
for 5-7 additional science officers to attend the International Stem
Cell Conference in Japan. It is important to CIRM that their
science officers understand the cutting edge research being developed
around the world so that CIRM does not fund redundant research; but,
to the contrary, the science officers understand how to create
networks between California scientists and scientists in other
foreign countries who are doing complementary research that can
potentially accelerate the advancements of therapies for patients. I
do not hold any financial interest in biotech companies. I have
historically been involved in encouraging international collaboration
to advance medical therapies; for patients, every day of delay in the
development of a therapy is a delay they cannot afford. To
conceptually document the value of additional scientists traveling to
these meetings, it was discussed that there should be conceptual,
bullet point summaries about the value for CIRM obtained through the
scientists discussions at the international conference. The
idea was to create bullet points of information about a few of the
most meaningful scientific concepts and contacts the science officers
benefitted from each day of attendance at the conference. I did not
participate in the selection of the science officers who attended and
I did not play any part in determining what activities they
participated in. There were two fundamental goals to the very short
one-on-one sessions that were arranged at "down time" that
would not conflict with their other activities. The first goal was to
conceptually understand if each of the science officers believed that
the benefit to the agency was sufficient to justify the cost of their
attending, when considering the learning and contacts they had gained
which might accelerate research and therapies for patients. The
second goal was to assist universities and non-profits, principally
in Canada - a research partner of CIRM - in advancing their
contributions from an existing donor or donors."The Canadian mining executive had an
important history in contributing to the International Stem Cell
Society and to Canadian non-profit research institutions. This
individual has an expert background in mining and a passionate
personal commitment to medical research; but, he does not engage in
technical discussions of research. On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual grants. The value of international
collaboration and the benefits of collaborating with new
international partners is discussed. Scientific theories and
individual grants are not discussed and new scientific information is
not presented. I attended this session of international partners to
support international collaboration; again, I do not hold any
financial interest in any biotech organizations. Additionally, I do
not have any business or financial relationship with the Canadian
mining executive. The Canadian executive, based upon family and
friends who have had chronic disease, is a significant donor to
non-profit research institutions in Canada. All of my activities, the
donation and the encouragement to develop information to validate the
future benefits of science officers traveling to international stem
cell conferences were focused on benefitting California patients with
chronic illness or injury and the agency formed through Proposition
71."
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SBGFem2qPWo/the-klein-donation-text-of-robert.html
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