Following publication of the British Medical Journal item below, we queried one of those mentioned, Kwang-Soo Kim, whether he had anything further to say on the matter. He forwarded the following via Tony Knight of Sitrick and Company, a public relations firm.
"After learning about this incident, I was quite frustrated and concerned
with the situation and, thus, personally investigated the matter by carefully discussing the details with each of the authors of the paper. My conclusion is that this is a most unfortunate situation stemming from a disgruntled junior scientist's unprofessional conduct which appears to have been unnecessarily amplified by an all-too-eager reporter who was either misinformed or is not properly reporting all the facts of the case.
"However, we are hopeful that with the disclosure and consideration of all the facts involved, a fair outcome will result not only in the pending legal proceeding but also with Fertility and Sterility.
"As a fellow research scientist with more than 23 years of research experience in the U.S., as well as knowledge of the scientific community in Korea, I feel some background information may prove to be helpful and insightful regarding the dual- publication issue.
"I personally have very strong objections to this practice where the dual publication in a non-SCI Korean journal and an SCI journal were pursued. I do not know for certain how widespread this practice has been in recent years. But I am pleased that it was halted in 2006 with the publication of a new guideline by Korean scientific leaders.
"Given that the practice of publishing in both a non-SCI domestic journal and a SCI international journal was accepted by some in Korean, it is somewhat understandable that Dr. Lee followed this practice, although I think it was a terrible mistake. All the other authors were not even aware of the fact that this paper was previously published in a Korean journal and, thus, are innocent.
"We at Pochon CHA University believe the matter should be corrected, and Dr. Lee is planning to retract the first paper from the Korean journal. The paper's scientific integrity is without question and it should remain in F&S.
"Based on my conversations with all of the other authors, I believe that Dr. Kim's contribution was marginal compared to the research project in total. Authorship of a scientific paper is based less on who drafted the text than on who performed the scientific work and whose original idea and investigative thought went into the research. In particular, in this type of genetic studies, it is crucial how the samples are organized and collected, including both patient and control samples. Dr. Kim deserves authorship because of his partial but direct contribution, and Dr. Lee did credit him as an author in her submission of the manuscript to F&S.
"Needless to say, the data and results produced from a lab are attributable to the principal investigator and the rightful, proprietary property of the sponsoring institution. The fact of the matter is that Dr. Lee was the principal investigator and director of the lab and all of the resulting data was attributable to Dr. Lee and the rightful property of CHA Hospital. It is also a fact that Dr. Kim took this data without anyone's knowledge or proper permission which was a huge violation of trust with Dr. Lee, the other researchers and the entire organization, as well as a serious breach of company policy and that of the implicit rule regarding research data and intellectual property within every research lab. I believe this is why he did not leave any contact information and could not be reached."
Showing posts with label comprehensive grants. Show all posts
Showing posts with label comprehensive grants. Show all posts
Sunday, April 08, 2007
Friday, April 06, 2007
Text of CHA Response to a Variety of Issues
The three following items were provided today by a representative of CHA in response to queries by the California Stem Cell Report. One is a letter to the editor of the Los Angeles Times, which has not been published as of the date of this writing. The other was sent to The Scientist magazine and is posted on their web site. The final document is information prepared in connection with the grant by the California stem cell agency to CHA RMI.
All of the items are posted verbatim as received from Tony Knight of Sitrick and Company, a Los Angeles "strategic communications" firm.
All of the items are posted verbatim as received from Tony Knight of Sitrick and Company, a Los Angeles "strategic communications" firm.
Cha Letter to Los Angeles Times
Text of letter to Los Angeles Times
Letters to the Editor
Los Angeles Times
202 W 1st Street
Los Angeles, CA 90012
Fax- 213-237-7679
letters@latimes.com
Dear Editor:
Your stories, “Stem cell grant OKd for L.A. center linked to allegations” (March 26) and “Credit for U.S. journal article at issue” (February 18), inaccurately portrayed the controversy over an article in the journal Fertility & Sterility as a “plagiarism dispute.”
As the one who originated the idea for the project and provided guidance and oversight for the collection of the patient samples, I was entitled under the relevant rules to a “first author” credit.
Dr. Jeong-Hwan Kim says he should have been listed as an author. In fact, Dr. Sook-Hwan Lee’s Feb. 5, 2005 letter to F&S, enclosing the manuscript, credited Dr. Kim with “clinicopathological analysis and statistical analysis." Even so, the sample data collection work had begun well before Dr. Kim became involved.
Dr. Kim’s name was dropped when he left Korea and he could not be found to sign the paperwork required by F&S. When Dr. Kim was located in 2006, Dr. Lee wrote letters to F&S asking his inclusion as an author.
The research was done at the Human Genetics Laboratory of CHA Hospital, where Dr. Lee was the director. Lab documentation shows that Dr. Kim’s contribution to the actual research was marginal. He collected two of the 30 patient samples, and none of the control samples. Other CHA doctors and laboratory scientists collected the other specimens and accomplished all DNA extraction. Dr. Kim compiled the basic statistics
and wrote the thesis in Korean.
As Dr. Lee informed The Times, Dr. Kim submitted the paper in Korean to the Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without her knowledge or consent. She translated the article into English for F&S, and she was the only author who knew of the prior KSOG publication.
None of the other authors, including myself, were aware of the article’s prior publication. Dr. Lee was correctly listed as an author on both papers, so plagiarism is also out of the question with regard to Dr. Lee.
Finally, your article said I had improperly used M.D. after my name on web sites of U.S. clinics and laboratories that are part of the CHA family of institutions. The web sites that refer to me are aimed at an international audience. I am the Chancellor of the College of Medicine at Pochon CHA University, a trained physician, licensed to practice medicine in Korea. I do not practice medicine in California and have never held myself out as a physician practicing in California.
Regards,
Kwang Yul Cha, M.D.
Chancellor
Pochon CHA University College of Medicine
Letters to the Editor
Los Angeles Times
202 W 1st Street
Los Angeles, CA 90012
Fax- 213-237-7679
letters@latimes.com
Dear Editor:
Your stories, “Stem cell grant OKd for L.A. center linked to allegations” (March 26) and “Credit for U.S. journal article at issue” (February 18), inaccurately portrayed the controversy over an article in the journal Fertility & Sterility as a “plagiarism dispute.”
As the one who originated the idea for the project and provided guidance and oversight for the collection of the patient samples, I was entitled under the relevant rules to a “first author” credit.
Dr. Jeong-Hwan Kim says he should have been listed as an author. In fact, Dr. Sook-Hwan Lee’s Feb. 5, 2005 letter to F&S, enclosing the manuscript, credited Dr. Kim with “clinicopathological analysis and statistical analysis." Even so, the sample data collection work had begun well before Dr. Kim became involved.
Dr. Kim’s name was dropped when he left Korea and he could not be found to sign the paperwork required by F&S. When Dr. Kim was located in 2006, Dr. Lee wrote letters to F&S asking his inclusion as an author.
The research was done at the Human Genetics Laboratory of CHA Hospital, where Dr. Lee was the director. Lab documentation shows that Dr. Kim’s contribution to the actual research was marginal. He collected two of the 30 patient samples, and none of the control samples. Other CHA doctors and laboratory scientists collected the other specimens and accomplished all DNA extraction. Dr. Kim compiled the basic statistics
and wrote the thesis in Korean.
As Dr. Lee informed The Times, Dr. Kim submitted the paper in Korean to the Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without her knowledge or consent. She translated the article into English for F&S, and she was the only author who knew of the prior KSOG publication.
None of the other authors, including myself, were aware of the article’s prior publication. Dr. Lee was correctly listed as an author on both papers, so plagiarism is also out of the question with regard to Dr. Lee.
Finally, your article said I had improperly used M.D. after my name on web sites of U.S. clinics and laboratories that are part of the CHA family of institutions. The web sites that refer to me are aimed at an international audience. I am the Chancellor of the College of Medicine at Pochon CHA University, a trained physician, licensed to practice medicine in Korea. I do not practice medicine in California and have never held myself out as a physician practicing in California.
Regards,
Kwang Yul Cha, M.D.
Chancellor
Pochon CHA University College of Medicine
Lee Letter to The Scientist
Text of letter to The Scientist
March 22, 2007
Richard Gallagher
Editor
The Scientist
Dear Editor:
Your February 20 article “Fertility journal censures scientists” contained inaccuracies and omitted important facts regarding a paper by myself and my colleagues in the journal Fertility & Sterility titled The Quantitative Analysis of Mitochondrial DNA Copy Number in Premature Ovarian Failure Patients Using the Real-Time Polymerase Chain Reaction (2005).
It is not true that Dr. Jeong Hwan Kim “performed the bulk of the research,” nor is it true the paper was submitted to F&S without Dr. Kim listed as an author. As of this writing, F&S has not censured me or any other authors. And Dr. DeCherney’s comment that all of the authors of the paper “perjured themselves” is baseless, as I will explain below.
The concept for this research originated with Dr. Kwang-Yul Cha in 1998. Dr. Cha and I designed and wrote the research proposal in 2001. Korea’s Ministry of Health and Welfare funded the research. My intent from the beginning was to seek publication in an SCI journal.
Most of the research was accomplished by myself and other researchers in the Human Genetics Laboratory of CHA Hospital. Dr. Kim became involved in 2002 when he asked for my guidance on his doctorate thesis and joined us as a part-time researcher.
I am told that he claims to have collected all 30 of the POF patient samples. We have documented proof he collected only two patients’ samples, and he collected no control samples. Other CHA Hospital doctors collected most specimens, and other scientists at the Human Genetics Laboratory accomplished all DNA extraction, prerequisite for real-time PCR. Dr. Kim compiled the basic statistics and wrote the thesis in Korean.
I agreed to help Dr. Kim with his doctoral thesis and permit him to participate in the research on the condition that any resulting paper would be submitted to an SCI journal. Upon receiving his degree from another institution, however, Dr. Kim submitted the thesis in Korean to the non-SCI Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without my knowledge or consent.
He also took all of our data without authorization and moved out of Korea leaving no forwarding address. I subsequently filed a legal complaint against Dr. Kim that is being investigated by the Korean Public Prosecutors Office.
Unable to locate Dr. Kim, KSOG recognized my name among the authors listed and contacted me. This was the first I was aware the paper had been submitted to KSOG.
Perhaps I should not have done so for my student, but I agreed to be the corresponding author when KSOG could not find Dr. Kim. (I am told that Dr. Kim says locating him would have been easy, but KSOG was unable to find him. More recently, an official Korean Public Prosecutors Office document stated that his whereabouts were “unverifiable.”)
The loss of our original data deprived me of an ability to write a second paper, yet I remained committed to submitting the research to an SCI publication. I translated the KSOG paper into English and submitted it to F&S with myself as the corresponding author.
Dr. Cha was listed as the first author on the F&S article because he originated the idea for the project and provided guidance and oversight for the collection of the patient samples. He was entitled under the relevant rules to “first author” credit.
Dr. Kim was included as an author on the original submission to F&S. My Feb. 5, 2005 letter to the editor of F&S, enclosing the manuscript, credited him with "clinicopathologica1 analysis and statistical analysis."
But Dr. Kim could not be found to sign paperwork required by F&S. His name was dropped for this reason only. When Dr Kim surfaced in 2006, I wrote two letters to F&S requesting his inclusion as an author. F&S never replied.
The paperwork F&S required the authors to sign was related to “financial” conflict of interests, not prior publication. None of the other authors, except myself, knew that the article had been published in KSOG. Hence, Dr. DeCherney’s ‘perjury’ allegation against the authors is without merit.
I express my sincere regret for the controversy and assume full responsibility as the corresponding author of the paper. No one else is to blame. No harm, sanctions or reputational damage should be directed to my co-authors.
I ask that you publish this letter in full in order to set the record straight.
Sincerely,
Sook-Hwan Lee, M.D., Ph.D
March 22, 2007
Richard Gallagher
Editor
The Scientist
Dear Editor:
Your February 20 article “Fertility journal censures scientists” contained inaccuracies and omitted important facts regarding a paper by myself and my colleagues in the journal Fertility & Sterility titled The Quantitative Analysis of Mitochondrial DNA Copy Number in Premature Ovarian Failure Patients Using the Real-Time Polymerase Chain Reaction (2005).
It is not true that Dr. Jeong Hwan Kim “performed the bulk of the research,” nor is it true the paper was submitted to F&S without Dr. Kim listed as an author. As of this writing, F&S has not censured me or any other authors. And Dr. DeCherney’s comment that all of the authors of the paper “perjured themselves” is baseless, as I will explain below.
The concept for this research originated with Dr. Kwang-Yul Cha in 1998. Dr. Cha and I designed and wrote the research proposal in 2001. Korea’s Ministry of Health and Welfare funded the research. My intent from the beginning was to seek publication in an SCI journal.
Most of the research was accomplished by myself and other researchers in the Human Genetics Laboratory of CHA Hospital. Dr. Kim became involved in 2002 when he asked for my guidance on his doctorate thesis and joined us as a part-time researcher.
I am told that he claims to have collected all 30 of the POF patient samples. We have documented proof he collected only two patients’ samples, and he collected no control samples. Other CHA Hospital doctors collected most specimens, and other scientists at the Human Genetics Laboratory accomplished all DNA extraction, prerequisite for real-time PCR. Dr. Kim compiled the basic statistics and wrote the thesis in Korean.
I agreed to help Dr. Kim with his doctoral thesis and permit him to participate in the research on the condition that any resulting paper would be submitted to an SCI journal. Upon receiving his degree from another institution, however, Dr. Kim submitted the thesis in Korean to the non-SCI Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without my knowledge or consent.
He also took all of our data without authorization and moved out of Korea leaving no forwarding address. I subsequently filed a legal complaint against Dr. Kim that is being investigated by the Korean Public Prosecutors Office.
Unable to locate Dr. Kim, KSOG recognized my name among the authors listed and contacted me. This was the first I was aware the paper had been submitted to KSOG.
Perhaps I should not have done so for my student, but I agreed to be the corresponding author when KSOG could not find Dr. Kim. (I am told that Dr. Kim says locating him would have been easy, but KSOG was unable to find him. More recently, an official Korean Public Prosecutors Office document stated that his whereabouts were “unverifiable.”)
The loss of our original data deprived me of an ability to write a second paper, yet I remained committed to submitting the research to an SCI publication. I translated the KSOG paper into English and submitted it to F&S with myself as the corresponding author.
Dr. Cha was listed as the first author on the F&S article because he originated the idea for the project and provided guidance and oversight for the collection of the patient samples. He was entitled under the relevant rules to “first author” credit.
Dr. Kim was included as an author on the original submission to F&S. My Feb. 5, 2005 letter to the editor of F&S, enclosing the manuscript, credited him with "clinicopathologica1 analysis and statistical analysis."
But Dr. Kim could not be found to sign paperwork required by F&S. His name was dropped for this reason only. When Dr Kim surfaced in 2006, I wrote two letters to F&S requesting his inclusion as an author. F&S never replied.
The paperwork F&S required the authors to sign was related to “financial” conflict of interests, not prior publication. None of the other authors, except myself, knew that the article had been published in KSOG. Hence, Dr. DeCherney’s ‘perjury’ allegation against the authors is without merit.
I express my sincere regret for the controversy and assume full responsibility as the corresponding author of the paper. No one else is to blame. No harm, sanctions or reputational damage should be directed to my co-authors.
I ask that you publish this letter in full in order to set the record straight.
Sincerely,
Sook-Hwan Lee, M.D., Ph.D
CHA RMI Statement on CIRM Grant
Text of the CHA RMI Statement:
March 24, 2007
Statement CHA Regenerative Medicine Institute
CHA Regenerative Medicine Institute is a non-profit organization
incorporated in California on Dec. 21, 2005 and has been engaged in
adult and embryonic stem cell research at its Los Angeles laboratory.
CHA RMI's mission is to develop regenerative cell and gene therapies for
the treatment and cure of human diseases. CHA RMI focuses its research
on advancing therapeutic cloning technology to create patient-specific
stem cells using fresh and frozen human eggs.
CHA RMI is able to bring to California patented vitrification technology
first developed at CHA BIOTECH and other advanced proprietary stem cell
technologies, which would otherwise not be available in the state,
because of its association with CHA Stem Cell Institute. All of CHA
RMI's facilities and research staff are located in California and all of
its work will be done in the state.
CHA RMI's research scientists are presently focused on:
* Production of embryonic stem cell lines from somatic cell
nuclear transfer- embryos
* Establishment of embryonic stem cells from donated eggs
* Differentiation of embryonic stem cells into specific cell
types.
* Investigation of adult stem cells for diabetes
CHA RMI's articles of incorporation state that it is organized under the
Nonprofit Public Benefit Law for charitable purposes and is not
organized for the private gain of any person. The articles further state
that the property of this corporation is irrevocably dedicated to
charitable purposes and no part of the net income or assets of this
corporation shall every inure to the benefit of any director, officer or
member thereof or to the benefit of any private person.
CHA RMI is associated with CHA BIOTECH, a leading stem cell research
institute in Korea, established in September 2000 by Pochon CHA
University College of Medicine and CHA General Hospital Group in order
to create a central, multidisciplinary research facility where the
university's scientists and hospital physicians could come together and
focus their efforts on developing stem cell, gene therapy and
regenerative medicine technology.
CHA BIOTECH, however, does not have any ownership interest in CHA RMI
nor does it have any voting rights on the Board. None of the member
companies belonging to CHA Health Systems have any ownership interest in
CHA RMI and none of the companies have any voting rights on CHA RMI's
Board.
Dr. Kwang Yul Cha, Chancellor of Pochon CHA University College of
Medicine, was listed as the initial chief executive and a member of the
Board of CHA RMI during the time when the non-profit laboratory was
being established. He has since resigned from these positions according
to the reorganization plan that was intended from the inception of the
institute. Dr. Cha does not hold any administrative or managerial title
at CHA RMI.
Dr. Cha is an internationally known fertility specialist with more than
100 articles published in peer-reviewed scientific journals. He received
his medical degree from Yonsei University in Seoul, Korea, and performed
his postdoctoral fellowship in endocrinology and infertility at the
University of Southern California. He also served as a visiting
professor at Columbia University
Dr. Cha succeeded with Korea's first Gamete Intra Fallopian Transfer,
Asia's first pregnancy in a woman without ovaries and the world's first
pregnancy from in vitro culture of immature oocytes collected from
unstimulated ovaries.
His research has received awards from the American Society for
Reproductive Medicine and the International Federation of Fertility
Societies. His research accomplishments have been featured in stories by
Time magazine, The New York Times and The Wall Street Journal.
Since its establishment in December 2005, CHA RMI has received approval
from the Western Institutional Review Board (WIRB) to conduct embryonic
stem cell research using frozen human eggs. This approval makes CHA RMI
the first research institute in the world to receive permission to
conduct stem cell research using frozen human eggs.
On March 16th, 2007, CHA RMI was awarded a $2,556,066 grant from the
California Institute for Regenerative Medicine (CIRM) to conduct
research in the "Establishment Of Stem Cell Lines From Somatic Cell
Nuclear Transfer-Embryos in Humans." The purpose of the research is to
provide a novel resource to the biomedical research community to study
and understand how genes correlate with the development of diseases such
as Amyotrophic Lateral Scelerosis (ALS), also known as Lou Gehrig's
disease.
CIRM's President and Chief Scientific Officer Zach W. Hall, Ph.D.,
stated: "These grants provide substantial support to a pool of very
distinguished researchers in human embryonic stem cell research." He
added that because of the size of the grants, "Our reviewers had higher
expectations and more rigorous standards for judging this set of
applications."
In its review of the "impact and significance" of the proposed research,
CIRM wrote: "As no ALS embryonic stem cells are currently available, the
isolation and characterization of such a diseased line will not only
provide the beginning of a proof of concept for this technology, but
more importantly will establish a realistic platform to study the
molecular basis of ALS, a devastating disease which remains incurable.
The other main significance of this work is the use of frozen oocytes
instead of fresh oocytes, which alleviates a number of ethical issues
regarding payments for donations to patients. This should not be
underestimated, as this simple fact is one of the major limitations of
SCNT approaches."
The principal investigator of the CIRM sponsored research is Jang-Won
Lee, Ph.D., who received his doctoral degree in animal science from the
University of Connecticut. Dr. Lee had been a research fellow at Wake
Forest Institute Regenerative Medicine, Winston Salem, NC and at
Children's Hospital & Harvard Medical School, Boston, MA. Before
assuming his post at CHA RMI, Dr. Lee holds an assistant professor
position at Pochon CHA University College of Medicine.
A full copy of the CIRM review can be found at:
http://www.cirm.ca.gov/publicsummaries/RFA_06-02/summary/RC1-00123-1.htm
l
March 24, 2007
Statement CHA Regenerative Medicine Institute
CHA Regenerative Medicine Institute is a non-profit organization
incorporated in California on Dec. 21, 2005 and has been engaged in
adult and embryonic stem cell research at its Los Angeles laboratory.
CHA RMI's mission is to develop regenerative cell and gene therapies for
the treatment and cure of human diseases. CHA RMI focuses its research
on advancing therapeutic cloning technology to create patient-specific
stem cells using fresh and frozen human eggs.
CHA RMI is able to bring to California patented vitrification technology
first developed at CHA BIOTECH and other advanced proprietary stem cell
technologies, which would otherwise not be available in the state,
because of its association with CHA Stem Cell Institute. All of CHA
RMI's facilities and research staff are located in California and all of
its work will be done in the state.
CHA RMI's research scientists are presently focused on:
* Production of embryonic stem cell lines from somatic cell
nuclear transfer- embryos
* Establishment of embryonic stem cells from donated eggs
* Differentiation of embryonic stem cells into specific cell
types.
* Investigation of adult stem cells for diabetes
CHA RMI's articles of incorporation state that it is organized under the
Nonprofit Public Benefit Law for charitable purposes and is not
organized for the private gain of any person. The articles further state
that the property of this corporation is irrevocably dedicated to
charitable purposes and no part of the net income or assets of this
corporation shall every inure to the benefit of any director, officer or
member thereof or to the benefit of any private person.
CHA RMI is associated with CHA BIOTECH, a leading stem cell research
institute in Korea, established in September 2000 by Pochon CHA
University College of Medicine and CHA General Hospital Group in order
to create a central, multidisciplinary research facility where the
university's scientists and hospital physicians could come together and
focus their efforts on developing stem cell, gene therapy and
regenerative medicine technology.
CHA BIOTECH, however, does not have any ownership interest in CHA RMI
nor does it have any voting rights on the Board. None of the member
companies belonging to CHA Health Systems have any ownership interest in
CHA RMI and none of the companies have any voting rights on CHA RMI's
Board.
Dr. Kwang Yul Cha, Chancellor of Pochon CHA University College of
Medicine, was listed as the initial chief executive and a member of the
Board of CHA RMI during the time when the non-profit laboratory was
being established. He has since resigned from these positions according
to the reorganization plan that was intended from the inception of the
institute. Dr. Cha does not hold any administrative or managerial title
at CHA RMI.
Dr. Cha is an internationally known fertility specialist with more than
100 articles published in peer-reviewed scientific journals. He received
his medical degree from Yonsei University in Seoul, Korea, and performed
his postdoctoral fellowship in endocrinology and infertility at the
University of Southern California. He also served as a visiting
professor at Columbia University
Dr. Cha succeeded with Korea's first Gamete Intra Fallopian Transfer,
Asia's first pregnancy in a woman without ovaries and the world's first
pregnancy from in vitro culture of immature oocytes collected from
unstimulated ovaries.
His research has received awards from the American Society for
Reproductive Medicine and the International Federation of Fertility
Societies. His research accomplishments have been featured in stories by
Time magazine, The New York Times and The Wall Street Journal.
Since its establishment in December 2005, CHA RMI has received approval
from the Western Institutional Review Board (WIRB) to conduct embryonic
stem cell research using frozen human eggs. This approval makes CHA RMI
the first research institute in the world to receive permission to
conduct stem cell research using frozen human eggs.
On March 16th, 2007, CHA RMI was awarded a $2,556,066 grant from the
California Institute for Regenerative Medicine (CIRM) to conduct
research in the "Establishment Of Stem Cell Lines From Somatic Cell
Nuclear Transfer-Embryos in Humans." The purpose of the research is to
provide a novel resource to the biomedical research community to study
and understand how genes correlate with the development of diseases such
as Amyotrophic Lateral Scelerosis (ALS), also known as Lou Gehrig's
disease.
CIRM's President and Chief Scientific Officer Zach W. Hall, Ph.D.,
stated: "These grants provide substantial support to a pool of very
distinguished researchers in human embryonic stem cell research." He
added that because of the size of the grants, "Our reviewers had higher
expectations and more rigorous standards for judging this set of
applications."
In its review of the "impact and significance" of the proposed research,
CIRM wrote: "As no ALS embryonic stem cells are currently available, the
isolation and characterization of such a diseased line will not only
provide the beginning of a proof of concept for this technology, but
more importantly will establish a realistic platform to study the
molecular basis of ALS, a devastating disease which remains incurable.
The other main significance of this work is the use of frozen oocytes
instead of fresh oocytes, which alleviates a number of ethical issues
regarding payments for donations to patients. This should not be
underestimated, as this simple fact is one of the major limitations of
SCNT approaches."
The principal investigator of the CIRM sponsored research is Jang-Won
Lee, Ph.D., who received his doctoral degree in animal science from the
University of Connecticut. Dr. Lee had been a research fellow at Wake
Forest Institute Regenerative Medicine, Winston Salem, NC and at
Children's Hospital & Harvard Medical School, Boston, MA. Before
assuming his post at CHA RMI, Dr. Lee holds an assistant professor
position at Pochon CHA University College of Medicine.
A full copy of the CIRM review can be found at:
http://www.cirm.ca.gov/publicsummaries/RFA_06-02/summary/RC1-00123-1.htm
l
British Medical Journal Discloses More Details in Cha Matter
The British Medical Journal has taken up the matter of Kwang Yul Cha and allegations of plagiarism against him, an issue that has raised concerns from two stem cell watch dog groups in California.
The four-page article in the April 7 issue of BMJ begins like this:
The BMJ article was written by Jonathan Gornall, who added details and new information to what already has been reported concerning Cha. Gornall wrote:
For previous items on the the CHA story, see "Secrecy," "Example," "CGS" and "FTCR."
The four-page article in the April 7 issue of BMJ begins like this:
"A bitter dispute over the authorship of a twice published medical paper has pitted a 35 year-old Korean doctor against one of the most powerful players in the country’s struggle for biotech supremacy. The battle is threatening to disrupt Korea’s efforts to recover scientific credibility in the wake of the recent scandal over Woo-Sok Hwang’s stem cell research."Cha is of special interest in California because the state's stem cell agency last month approved a $2.6 million research grant to a non-profit subsidiary, CHA RMI, of the CHA Health Systems organization, which is headed by Cha. The Oversight Committee of the California stem cell agency approved the grant with little discussion and no public notice prior to approval that it was for CHI RMI. CIRM's standard practice is to withhold the names of grant applicants. Following public disclosure six days later of the linkage between CHA RMI and Cha, two watchdog groups raised questions about grant.
The BMJ article was written by Jonathan Gornall, who added details and new information to what already has been reported concerning Cha. Gornall wrote:
"Now, as the dispute escalates into a series of allegations and counter allegations, the editor in chief of Fertility and Sterility has been accused of defamation and threatened with legal action by Dr. Cha. However, the BMJ has also learnt that following an investigation by the public prosecutor’s office in Korea, Dr. Sook Hwan Lee, one of Dr. Cha’s coauthors on the disputed paper, has been charged with criminal copyright infringement. The dispute is a major embarrassment for the CHA organisation, which only recently hired Professor Kwang Soo Kim, a respected Harvard professor, to boost its credibility in stem cell research."Gornall continued:
"On 7 March, Dr.(Alan) DeCherney (editor of Fertility and Sterility) received a letter from lawyers acting on behalf of Dr. Cha. It quoted comments attributed to him in the LA Times on 18 February and in The Scientist on 20 February and accused him of having made 'false and defamatory statements' about Dr. Cha. It threatened legal action and demanded that Dr. DeCherney sign a statement of retraction. The letter, seen by the BMJ, calls for Dr. DeCherney to 'acknowledge that 1) Dr. Cha was entitled to be credited as an author of the F&S [Fertility and Sterility] article; 2) you have no reason to disbelieve Dr. Cha’s statement that he was unaware of the prior publication in the KSOG Journal; and 3) Dr. Cha did not plagiarise Dr. (Jeong Hwan) Kim’s work, in that Dr. Kim’s name was on the list of authors initially submitted to F&S by Dr. Lee, and was only omitted because he could not be located.'"Gornall continued:
"Professor Kwang Soo Kim, director of the molecular neurobiology laboratory at Harvard’s Mclean Hospital and the newly recruited codirector of the CHA Stem Cell Institute, now finds himself having to defend his new employer. No fewer than three of his new colleagues at the institute including his fellow codirector, Hyung Min Chung are among the disputed authors on the paper. In February he wrote to Dr. DeCherney of Fertility and Sterility on behalf of the CHA organisation as 'a fellow research scientist with more than 23 years of research experience in the US as well as first-hand knowledge of standard practices in the scientific community in Korea,' to express regret about the incident.We have queried DeCherney concerning his response to the letter from Cha's lawyers.
"In his letter, a copy of which the CHA organisation sent to the BMJ, he suggests that 'The main issue that appears to be at the center of this controversy is the multiple publication of the paper.' But he then makes a disturbing disclosure: 'In Korea, it has been a customary practice and an accepted procedure by the scientific community to submit top-quality research outcomes concurrently (or subsequently) to internationally-recognized journals in an effort to promote and advance the work of Korean scientists, which was also the case when Dr Lee submitted her paper to Fertility and Sterility.
"'I personally have very strong objections to this practice and have been trying to convince the scientific leaders in Korea to put a stop to this. It was only recently in 2006 that this guideline was in fact revised in Korea to prohibit this practice.'
"Professor Kim’s intervention leaves little doubt about how seriously the CHA group views the potential of the incident to damage its bid to inherit Hwang’s crown: 'The reputation and credibility of our university and that of its researchers and scientists are also at stake,' Professor Kim writes. 'This is an extremely critical issue in light of the fact that I believe our institution will serve a pivotal role in restoring the severely damaged reputation and credibility of stem cell and life science research in Korea after the Hwang scandal.'"
For previous items on the the CHA story, see "Secrecy," "Example," "CGS" and "FTCR."
Sunday, April 01, 2007
Secrecy and California's $100 Million in Stem Cell Grants
More than two years ago, a legal expert on California's "sunshine" laws said the state's $3 billion stem cell agency should open its doors wider and fulfill its then fledgling promise to meet the highest standards of openness and transparency.
Terry Francke, general counsel for Californians Aware, zeroed in on the manner in which CIRM decides which scientists are selected to receive millions of dollars in public funds. Francke said the task should be performed mostly in public, which would provide "vital insurance" that public needs are met and no mischief is afoot.
CIRM's Oversight Committee rejected that position, and today we are beginning to see the impact. It comes in the form of a lack of vital information about how the agency has handed out more than $100 million in research grants. It involves the failure of the agency to keep minutes or transcripts of key sessions of its grant review committee, compliance with the state's constitutional guarantee of the "people's right to access" governmental information and the role of the chair of the agency during one closed-door grant review.
The case in point is a $2.6 million grant to CHA RMI, a 15-month-old nonprofit subsidiary of CHA Health Systems of Korea. Like 28 other applications, the Los Angeles-based RMI went through review and approval earlier this year. But the grant has now risen to higher visibility because of what one watchdog group called "troubling questions" about plagiarism allegations concerning Kwang-Yul Cha, president of CHA RMI's parent company, and alleged ethical breaches involving the medical director of RMI's allied fertility clinic.
How did the CHA RMI application come to be in the top tier of grants approved for funding, setting it up for no-questions-asked approval by CIRM's 29-member Oversight Committee? What can the public learn about the process that does not involve the closely protected scientific details of the grants or proprietary information? For example, can the public learn what the key vote was on the CHA RMI application during the initial review? Can the public learn if other votes were taken that would have affected CHA RMI's possible approval? Can the public determine whether the organization's reputation was discussed by grant reviewers, much less what was said?
Using CHA RMI as an example, here is a look at the grant review process, what the public is allowed to know and what is kept secret by the California stem cell agency.
In January during a closed-door session, the CIRM grant review committee (14 out-of-state scientists and seven patient advocate members of the CIRM's Oversight Committee, including its chair) placed the CHA RMI grant in the top tier of those to be funded. The names of all applicants, however, were secret at the time. On Feb. 18, the Los Angeles Times carried its story about the plagiarism allegations and other issues involving Cha, the top executive of the parent company of CHA RMI. On Feb. 23, the Los Angeles Times carried another story about the CHA fertility clinic. Neither story specifically mentioned CHA RMI. On March 15, CIRM's Oversight Committee, approved the CHA RMI grant with little discussion as part of a block of other top-ranked grants. Under CIRM rules, Oversight Committee members (with the exception those who served on the grant review panel) did not know the name of any of the recipient organizations before they voted. So it was impossible for most Oversight Committee members to connect the CHA RMI application with either of the Times' stories. After the vote, the names of the winners were released by CIRM. The names of the other applicants remain secret. Public linkage of the Times reports and the CHA RMI grant came only on March 17 on the Bodyhack blog on Wired.com and on March 21 in the California Stem Cell Report. Other media followed the March 21 report.
What the public knew about all the grants prior to its approval can be seen on the CIRM web site, which carried, in advance of the Oversight Committee meeting, a summary of each application and reviewers' assessment of its strengths and weaknesses – minus names of the applicant. That summary and assessment surpasses the information disclosed about grant applications by the National Institutes of Health, the federal agency for making most scientific research grants, and other grant-making organizations with the exception of Connecticut's stem cell research effort, according to CIRM.
What is not known publicly is also significant. Here are questions that remain unanswered.
-- Did California stem cell Chairman Robert Klein, who met Cha in October 2005 in Korea on trip financed by a Korean trade organization, take part in the discussion of the CHA RMI application during its review by the grant committee?
-- What was the vote by the grant review committee on the CHA RMI application, a vote that is required by the grant review committee's bylaws?
-- Were other votes taken that would affect the placement of CHA RMI grant in the top tier? Such as a vote on the cutoff score for placing applications in the top tier? The CHA RMI application received a scientific score of 77, nine points above cutoff line and 18 below the top score.
-- Did any grant reviewers raise questions about CHA RMI's reputation or that of its allied organizations?
CIRM would not disclose the vote on the CHA RMI application. The agency declined to disclose whether the CHA RMI grant was considered separately or together with other grants. CIRM declined to disclose whether there was a vote on the cutoff score for tier one grants. No transcripts, minutes or audio tapes exist from the meeting, although notes were taken by CIRM staff to prepare the public summaries of the grants.
Dale Carlson, chief communications officer for CIRM, said at one point said via email, "We think the public summaries of the discussion speak for themselves." He later added, "From the ranked list of Comprehensive Grant applications...anyone can see that it's clear the CHA application made it into Tier I on the strength of its scientific score."
Responding to a general question about the review process, Stuart Orkin, Harvard medical professor and chair of the grant review committee, said, "I think it is a very fair and transparent process for selection of the best and most promising grants for the CIRM."
Regarding the lack of transcript and minutes, Carlson said, "We keep very careful records on the (grant reviewers) who vote and have conflicts. They are retained and available for review by auditors."
CIRM declined to disclose whether Klein took part in the discussion of the CHA RMI application, but noted that he sits ex officio on the committee and does not have a vote.
Klein was in Korea in October 2005. Carlson said that he met with Cha at that time but offered no further details. In economic disclosure statements filed with the state, Klein, a multimillionaire who takes no salary for his post with CIRM, listed a gift from CHA Health Systems on Oct. 16, 2005, valued at $100. It was described as a "stone stamp/seal." Klein also received a decorative box valued at $175 from the Korean International Trade Association during the trip, which was paid for by the same association. The flight was valued at $4,170 and his one-night hotel stay at $509, according to Klein's filings. He reported that he spoke at a symposium and three research hospitals. Klein received no honorarium or other fee for his speeches, according to state filings. His trip was made to join in the announcement of an international stem cell consortium being organized by then stem-cell superstar Woo Suk Hwang, according to published reports. The consortium later collapsed when Hwang confessed to stem cell research fraud and was indicted on embezzlement and bioethics law violations.
Carlson said,
During the same election in which Prop. 71 was passed, California voters also adopted Prop. 59, amending the state Constitution to guarantee the public's right to government records. The constitutional amendment states: "A statute, court rule, or other authority, including those in effect on the effective date of this subdivision, shall be broadly construed if it furthers the people's right of access, and narrowly construed if it limits the right of access." The measure was approved by 89 percent of voters, far exceeding the 59 percent for Prop. 71. That is significant because courts have used approval rates in some cases to determine precedence in case of conflicting measures.
Does the voter-approved Constitutional provision mean that CIRM must open its processes? That question is not likely to be completely answered short of litigation that would probably proceed to the State Supreme Court. Other possibilities include a legislative change in Prop. 71, which requires an overwhelming 70 percent vote in both houses, or an attorney general opinion. Those can be requested by legislators or state agencies and carry considerable legal weight. CIRM can also change its policies on its own volition.
Terry Francke, general counsel for Californians Aware, zeroed in on the manner in which CIRM decides which scientists are selected to receive millions of dollars in public funds. Francke said the task should be performed mostly in public, which would provide "vital insurance" that public needs are met and no mischief is afoot.
CIRM's Oversight Committee rejected that position, and today we are beginning to see the impact. It comes in the form of a lack of vital information about how the agency has handed out more than $100 million in research grants. It involves the failure of the agency to keep minutes or transcripts of key sessions of its grant review committee, compliance with the state's constitutional guarantee of the "people's right to access" governmental information and the role of the chair of the agency during one closed-door grant review.
The case in point is a $2.6 million grant to CHA RMI, a 15-month-old nonprofit subsidiary of CHA Health Systems of Korea. Like 28 other applications, the Los Angeles-based RMI went through review and approval earlier this year. But the grant has now risen to higher visibility because of what one watchdog group called "troubling questions" about plagiarism allegations concerning Kwang-Yul Cha, president of CHA RMI's parent company, and alleged ethical breaches involving the medical director of RMI's allied fertility clinic.
How did the CHA RMI application come to be in the top tier of grants approved for funding, setting it up for no-questions-asked approval by CIRM's 29-member Oversight Committee? What can the public learn about the process that does not involve the closely protected scientific details of the grants or proprietary information? For example, can the public learn what the key vote was on the CHA RMI application during the initial review? Can the public learn if other votes were taken that would have affected CHA RMI's possible approval? Can the public determine whether the organization's reputation was discussed by grant reviewers, much less what was said?
Using CHA RMI as an example, here is a look at the grant review process, what the public is allowed to know and what is kept secret by the California stem cell agency.
In January during a closed-door session, the CIRM grant review committee (14 out-of-state scientists and seven patient advocate members of the CIRM's Oversight Committee, including its chair) placed the CHA RMI grant in the top tier of those to be funded. The names of all applicants, however, were secret at the time. On Feb. 18, the Los Angeles Times carried its story about the plagiarism allegations and other issues involving Cha, the top executive of the parent company of CHA RMI. On Feb. 23, the Los Angeles Times carried another story about the CHA fertility clinic. Neither story specifically mentioned CHA RMI. On March 15, CIRM's Oversight Committee, approved the CHA RMI grant with little discussion as part of a block of other top-ranked grants. Under CIRM rules, Oversight Committee members (with the exception those who served on the grant review panel) did not know the name of any of the recipient organizations before they voted. So it was impossible for most Oversight Committee members to connect the CHA RMI application with either of the Times' stories. After the vote, the names of the winners were released by CIRM. The names of the other applicants remain secret. Public linkage of the Times reports and the CHA RMI grant came only on March 17 on the Bodyhack blog on Wired.com and on March 21 in the California Stem Cell Report. Other media followed the March 21 report.
What the public knew about all the grants prior to its approval can be seen on the CIRM web site, which carried, in advance of the Oversight Committee meeting, a summary of each application and reviewers' assessment of its strengths and weaknesses – minus names of the applicant. That summary and assessment surpasses the information disclosed about grant applications by the National Institutes of Health, the federal agency for making most scientific research grants, and other grant-making organizations with the exception of Connecticut's stem cell research effort, according to CIRM.
What is not known publicly is also significant. Here are questions that remain unanswered.
-- Did California stem cell Chairman Robert Klein, who met Cha in October 2005 in Korea on trip financed by a Korean trade organization, take part in the discussion of the CHA RMI application during its review by the grant committee?
-- What was the vote by the grant review committee on the CHA RMI application, a vote that is required by the grant review committee's bylaws?
-- Were other votes taken that would affect the placement of CHA RMI grant in the top tier? Such as a vote on the cutoff score for placing applications in the top tier? The CHA RMI application received a scientific score of 77, nine points above cutoff line and 18 below the top score.
-- Did any grant reviewers raise questions about CHA RMI's reputation or that of its allied organizations?
CIRM would not disclose the vote on the CHA RMI application. The agency declined to disclose whether the CHA RMI grant was considered separately or together with other grants. CIRM declined to disclose whether there was a vote on the cutoff score for tier one grants. No transcripts, minutes or audio tapes exist from the meeting, although notes were taken by CIRM staff to prepare the public summaries of the grants.
Dale Carlson, chief communications officer for CIRM, said at one point said via email, "We think the public summaries of the discussion speak for themselves." He later added, "From the ranked list of Comprehensive Grant applications...anyone can see that it's clear the CHA application made it into Tier I on the strength of its scientific score."
Responding to a general question about the review process, Stuart Orkin, Harvard medical professor and chair of the grant review committee, said, "I think it is a very fair and transparent process for selection of the best and most promising grants for the CIRM."
Regarding the lack of transcript and minutes, Carlson said, "We keep very careful records on the (grant reviewers) who vote and have conflicts. They are retained and available for review by auditors."
CIRM declined to disclose whether Klein took part in the discussion of the CHA RMI application, but noted that he sits ex officio on the committee and does not have a vote.
Klein was in Korea in October 2005. Carlson said that he met with Cha at that time but offered no further details. In economic disclosure statements filed with the state, Klein, a multimillionaire who takes no salary for his post with CIRM, listed a gift from CHA Health Systems on Oct. 16, 2005, valued at $100. It was described as a "stone stamp/seal." Klein also received a decorative box valued at $175 from the Korean International Trade Association during the trip, which was paid for by the same association. The flight was valued at $4,170 and his one-night hotel stay at $509, according to Klein's filings. He reported that he spoke at a symposium and three research hospitals. Klein received no honorarium or other fee for his speeches, according to state filings. His trip was made to join in the announcement of an international stem cell consortium being organized by then stem-cell superstar Woo Suk Hwang, according to published reports. The consortium later collapsed when Hwang confessed to stem cell research fraud and was indicted on embezzlement and bioethics law violations.
Carlson said,
"Klein's probably met hundreds of scientists in California and elsewhere in the past couple of years, including many with applications considered by the ICOC. That's probably true for most, if not all, members of theWe asked Carlson whether CIRM, prior to the working group review of grants, gathered any information on grant applicants and their institutions? His response:
ICOC. They are, after all, a pretty high-profile group with a lot of public interaction. What's your point? Meeting someone does not constitute a conflict of interest."
"In the interest of effectively managing our scarce resources, the rigorous due diligence conducted on each applicant investigator and/or institution is undertaken after the ICOC votes to approve grants for funding. The administrative review is an intensive process, as I'm sure you can imagine. With 300 applications for SEED and Comp grants, for example, and an expectation that the ICOC would approve just 55, it wouldn't be prudent to examine all 300 to see if they met the requirements of the RFAs. Better to focus our limited time on those that actually have a chance of a grant award."We also asked Carlson whether, during the grant review process, there was any discussion of CHA's reputation or that of its parent or allied organizations? Or of the reputations of the CHA scientists or management or scientists and other personnel associated with CHA's allied organizations? He replied,
"The public summary indicates that there was discussion of the capabilities of the principal investigator and his collaborators. The focus is on scientific merit. Exclusively, scientific merit.As for the agency's position on withholding information on votes and other non-scientific information involved in the grant reviews, Prop. 71 states: "All records of the working groups SUBMITTED (our capitalization) as part of the working groups’ recommendations to the ICOC for approval shall be subject to the Public Records Act." That phrasing apparently serves as the legal foundation for the institute's position that it may withhold any information that is not submitted as part of the grant review's formal recommendations. The language is part of state law as opposed to the State Constitution.
"I think it's worth noting that none of the stories referenced by (watchdog groups and others) had surfaced at the time the application was submitted or reviewed."
During the same election in which Prop. 71 was passed, California voters also adopted Prop. 59, amending the state Constitution to guarantee the public's right to government records. The constitutional amendment states: "A statute, court rule, or other authority, including those in effect on the effective date of this subdivision, shall be broadly construed if it furthers the people's right of access, and narrowly construed if it limits the right of access." The measure was approved by 89 percent of voters, far exceeding the 59 percent for Prop. 71. That is significant because courts have used approval rates in some cases to determine precedence in case of conflicting measures.
Does the voter-approved Constitutional provision mean that CIRM must open its processes? That question is not likely to be completely answered short of litigation that would probably proceed to the State Supreme Court. Other possibilities include a legislative change in Prop. 71, which requires an overwhelming 70 percent vote in both houses, or an attorney general opinion. Those can be requested by legislators or state agencies and carry considerable legal weight. CIRM can also change its policies on its own volition.
Friday, March 23, 2007
RHA RMI Issues Receive Little Notice in Media
The flap over the $2.6 million California stem cell grant to a Los Angeles enterprise linked to ethical lapses involving a Korean scientist received scant attention today in California newspapers.
Only one story appeared in a newspaper, and one online. Neither contained much new information. Reporter Carl Hall of the San Francisco Chronicle did carry a comment from CHA Health Systems, the parent company for CHA Regenerative Medicine Institute, which was approved for the grant last week by the CIRM Oversight Committee. Hall wrote:
The Californa stem cell agency said it was in the process of conducting a routine review of all the grants approved last week, which will include an examination of whether each recipient is eligible for the award. Waters quoted the agency as saying that the review could take six weeks.
The Bodyhack blog on Wired.com was the first (on March 17) to pull together the plagiarism allegations involving the head of CHA Health Systems along with other ethical concerns involving CHA and point out that a CHA subsidiary had been approved for the $2.6 million state grant. The California Stem Cell Report on the matter appeared Wednesday night and led to the calls for the investigation.
We have emailed CHA several times seeking a comment on the matter, including a promise to run their comments verbatim. We will do so when we receive a response.
(Editor's note: An earlier version of this story incorrectly said that the California Stem Cell Report was the first to link the CIRM grant and the ethical concerns involving CHA.)
Only one story appeared in a newspaper, and one online. Neither contained much new information. Reporter Carl Hall of the San Francisco Chronicle did carry a comment from CHA Health Systems, the parent company for CHA Regenerative Medicine Institute, which was approved for the grant last week by the CIRM Oversight Committee. Hall wrote:
"Jason Booth, a spokesman in Los Angeles for CHA Health Systems, said the research unit is a bona fide California nonprofit whose status was not at issue, and that its 'grant was based on a thorough scientific review that speaks for itself.'"Rob Waters of Bloomberg.com, who was the first to point out the connection between CHA Health Systems and CHA RMI, also reported on the calls for an investigation. He said a representative of CHA in Korea said the company would respond later.
The Californa stem cell agency said it was in the process of conducting a routine review of all the grants approved last week, which will include an examination of whether each recipient is eligible for the award. Waters quoted the agency as saying that the review could take six weeks.
The Bodyhack blog on Wired.com was the first (on March 17) to pull together the plagiarism allegations involving the head of CHA Health Systems along with other ethical concerns involving CHA and point out that a CHA subsidiary had been approved for the $2.6 million state grant. The California Stem Cell Report on the matter appeared Wednesday night and led to the calls for the investigation.
We have emailed CHA several times seeking a comment on the matter, including a promise to run their comments verbatim. We will do so when we receive a response.
(Editor's note: An earlier version of this story incorrectly said that the California Stem Cell Report was the first to link the CIRM grant and the ethical concerns involving CHA.)
Thursday, March 22, 2007
Advisory
The press release by the Center for Genetics and Society concerning the CHA grant has now been posted on its web site. Here is the location.
The CHA Example: How CIRM Decides Who Gets the Big Bucks
The $2.6 million California stem cell grant involving the CHA Regenerative Medicine Institute received a score of 77 from a panel of grant reviewers, although they commented that it "can be easily qualified as overly ambitious."
Approval of the application last week by the Oversight Committee of the California Institute for Regenerative Medicine has resulted in calls for an investigation into CHA RMI's nonprofit status and its links to a Korean scientist involved in an international plagiarism case, among other things.
The CHA application first came up for a review last January by a CIRM working group, chaired by Stuart Orkin of the Dana Farber Cancer Institute. Fourteen other scientists held seats on the group. Seven members of the Oversight Committee sat on the panel. Only one is from Los Angeles, where CHA RMI has its office. It is not known whether she was in attendance when the CHA application was discussed. All of the scientists are from out-of-state.
Meeting privately, the reviewers recommended the CHA application and others for funding. The CHA application was placed in the first tier of grants that were sent on to the Oversight Committee. The scores of the first tier grants ranged from 95 to 66. The reviewers received detailed information on the proposal, including the names of the principal researcher as well as its methodology. Only one reviewer was recused from considering the grant. He was Jeffrey Rothstein of John Hopkins, who works in ALS research, a field that was also targeted by the grant.
Prior to action by the Oversight Committee, the names of all CIRM grant applicants and their institutions are secret except during the private meetings of reviewers, according to CIRM policies. The Oversight Committee is also not told their names during the votes on the reviewers' recommendations. The names of the winning applicants are only disclosed after the vote. The names of the losers will never be disclosed by CIRM.
CIRM says its secrecy is justified for a number of reasons. The agency says it is the traditional way grant applications are handled in the scientific community. It is professionally damaging, CIRM also says, for scientists to be publicly identified as not being able to win grants. It is also damaging to be criticized in public. Maintaining secrecy means that scientists are more likely to propose more ambitious and riskier research than would otherwise be the case. The results of science will be better in the aggregate, thus benefitting the public more than would identifying the applicants and their institutions, CIRM says.
During last week's Oversight Committee meetings when the grants were approved, the 29 members of that panel were not told the names of the applicants or the institutions. They were given a summary that is also available to the public. Individual members were given a list of the grants by number on which they could not vote or participate in the debate. Those lists were withheld from the public at the meeting. Just prior to voting on or discussing an individual grant, a list was read of the committee members who could not participate in the debate. At that point, well-informed members of the audience and probably many members of the committee could identify the actual institutions involved and often the individual researchers. The persons who could not are ones who are not as well informed on stem cell research.
The Oversight Committee voted on the first tier of grants as a block. At that point, no list of recused members was read to the public. Rather each member announced that they were voting in favor of the block with exception of grants where they had a conflict. CIRM's outside counsel recommended the procedure.
Following the vote, CIRM posted a list on the Internet of Oversight Committee members recused from voting on the CHA grant. They are Ricardo Azziz, chair of Department of Obstetrics and Gynecology at Cedars-Sinai in Los Angeles, Jeanne Fontana, a surrogate for John Reed, head of the Burnham Institute in La Jolla, and Richard Murphy, president of the Salk Institute, also in the La Jolla area. Reasons for their recusal were not posted.
(The California Stem Cell Report has argued often against much of the secrecy in the grant-making process for a variety of reasons. We will write more about the issue later.)
In response to a query, Dale Carlson, chief communications officer for CIRM, supplied the following:
Below is the text of the strengths and weaknesses of his application based on the CIRM reviewers assessment. More information on the grant can be found at this location.
Approval of the application last week by the Oversight Committee of the California Institute for Regenerative Medicine has resulted in calls for an investigation into CHA RMI's nonprofit status and its links to a Korean scientist involved in an international plagiarism case, among other things.
The CHA application first came up for a review last January by a CIRM working group, chaired by Stuart Orkin of the Dana Farber Cancer Institute. Fourteen other scientists held seats on the group. Seven members of the Oversight Committee sat on the panel. Only one is from Los Angeles, where CHA RMI has its office. It is not known whether she was in attendance when the CHA application was discussed. All of the scientists are from out-of-state.
Meeting privately, the reviewers recommended the CHA application and others for funding. The CHA application was placed in the first tier of grants that were sent on to the Oversight Committee. The scores of the first tier grants ranged from 95 to 66. The reviewers received detailed information on the proposal, including the names of the principal researcher as well as its methodology. Only one reviewer was recused from considering the grant. He was Jeffrey Rothstein of John Hopkins, who works in ALS research, a field that was also targeted by the grant.
Prior to action by the Oversight Committee, the names of all CIRM grant applicants and their institutions are secret except during the private meetings of reviewers, according to CIRM policies. The Oversight Committee is also not told their names during the votes on the reviewers' recommendations. The names of the winning applicants are only disclosed after the vote. The names of the losers will never be disclosed by CIRM.
CIRM says its secrecy is justified for a number of reasons. The agency says it is the traditional way grant applications are handled in the scientific community. It is professionally damaging, CIRM also says, for scientists to be publicly identified as not being able to win grants. It is also damaging to be criticized in public. Maintaining secrecy means that scientists are more likely to propose more ambitious and riskier research than would otherwise be the case. The results of science will be better in the aggregate, thus benefitting the public more than would identifying the applicants and their institutions, CIRM says.
During last week's Oversight Committee meetings when the grants were approved, the 29 members of that panel were not told the names of the applicants or the institutions. They were given a summary that is also available to the public. Individual members were given a list of the grants by number on which they could not vote or participate in the debate. Those lists were withheld from the public at the meeting. Just prior to voting on or discussing an individual grant, a list was read of the committee members who could not participate in the debate. At that point, well-informed members of the audience and probably many members of the committee could identify the actual institutions involved and often the individual researchers. The persons who could not are ones who are not as well informed on stem cell research.
The Oversight Committee voted on the first tier of grants as a block. At that point, no list of recused members was read to the public. Rather each member announced that they were voting in favor of the block with exception of grants where they had a conflict. CIRM's outside counsel recommended the procedure.
Following the vote, CIRM posted a list on the Internet of Oversight Committee members recused from voting on the CHA grant. They are Ricardo Azziz, chair of Department of Obstetrics and Gynecology at Cedars-Sinai in Los Angeles, Jeanne Fontana, a surrogate for John Reed, head of the Burnham Institute in La Jolla, and Richard Murphy, president of the Salk Institute, also in the La Jolla area. Reasons for their recusal were not posted.
(The California Stem Cell Report has argued often against much of the secrecy in the grant-making process for a variety of reasons. We will write more about the issue later.)
In response to a query, Dale Carlson, chief communications officer for CIRM, supplied the following:
"The CIRM grant review and administration process does not end with the ICOC's vote on deciding which applications to approve or not approve for funding. To that point, the review process by the Grants Working Group is focused on scientific merit. After that, there is an internal administrative review by Institute staff to ensure that each approved application is from an institution and principal investigator that meet the eligibility requirements of the specific Request for Applications (RFA); of the requested budget and proposed facilities for the proposed project; and of the institution's mechanisms for complying with our grants administration policy and medical and ethical standards.The principal investigator on the CHI RMI grant is Jang-Won Lee. Little information is available about him on the CIRM web site. Carlson said the score of 77 on his grant is an average of each score by each reviewer. Here are the rankings of the grants.
"The administrative review process can take several weeks (we are still working on the SEED grants approved in mid-February, for example) and only after it's completed to our satisfaction do Notice of Grant Awards (NGAs) go out to recipient institutions and researchers. Checks follow NGAs.
"The NIH grants review process is similar."
Below is the text of the strengths and weaknesses of his application based on the CIRM reviewers assessment. More information on the grant can be found at this location.
"STRENGTHS: The proposal is well-written and includes preliminary data in pigs and novel methods. The research plan is nicely developed and the PI has the appropriate expertise, at least in animal cloning (less with hESCs), to be successful in this endeavor. Success of the PI in the porcine model adds strength to the plan. A large collection of letters of support provides evidence of enthusiastic collaboration with the PI that will add critically needed expertise to the project. The plan to differentiate and transplant hESC-derived neural cells in a well-established mouse model with experts in the field strengthens the lack of experience with hESC culture (but not derivation) by the rest of the group.
"WEAKNESSES: This is a proposal that can be easily qualified as overly ambitious. The author provides a shopping list of all the experiments that will happen after the ALS SCNT embryos have successfully been established and characterized. This seems premature. The proposal would be successful if the derivation is first done accurately and convincingly to generate a handful of lines that will be available for the community. Preliminary data on enucleation, SCNT and hESC derivation in an animal model should be done before proposing these studies. Specifically, SCNT on frozen oocytes in an animal model should be done before using completely viable, clinically useful human oocytes. The use of frozen oocytes for SCNT has not been established, and is likely to be a significant technical problem for enucleation and whole cell injection. There is no indication of a plan to enucleate the oocytes in the proposal and a clear rationale for using one or both of the methods used previously by the collaborator who developed the method is required. A plan for the derivation of hESCs is also needed along with a rationale for the use of ALS cells for tranplantation studies, rather than normal cells. It also appears that no one on this project has experience with this hESC derivation, or the derivation of any ESC lines.
"The section on clinical grade ESCs is not necessary for the proposal and should be removed. These ESCs are not stable lines that have been shown to be maintained in vitro. In fact, they appear by the literature and preliminary data to be a mixture of hESCs and hESC-derived differentiated populations. The plans to differentiate hESCs for transplantation do not require this intermediate step. It is unfortunate, because the application of novel SCNT techniques is a reasonable way to move the field of SCNT and hESC biology forward. If the rest of the proposal was as well-designed as the pig studies, the score would be very high."
Saturday, March 17, 2007
Grant Coverage Light, Bloomberg Highlights Korean-linked Award
The announcement of nearly $76 million in embryonic stem cell research grants in California generated modest media attention today – less than last month's giveaway that involved much less money. The presence of Gov. Arnold Schwarzenegger, however, helped push the coverage of February's awards to an exceptional level. Plus they were the first awarded by CIRM.
Few surprises popped up in the papers today. But reporter Rob Waters of Bloomberg.com highlighted the Korean connections of one Los Angeles-based recipient. Waters wrote:
Most reporters focused on the dollars in the grants. But Jim Downing of The Sacramento Bee zeroed in on the researchers and their goals. The first two paragraphs of his story read:
Steve Johnson, San Jose Mercury News
Carl Hall, San Francisco Chronicle
Reporter Terri Somers, San Diego Union-Tribune
Mary Engel, Los Angeles Times
Gary Robbins, Orange Country Register
People's Daily Online
UCLA
UC San Diego
UC San Francisco
Burnham Institute
Stanford
Few surprises popped up in the papers today. But reporter Rob Waters of Bloomberg.com highlighted the Korean connections of one Los Angeles-based recipient. Waters wrote:
"CHA RMI was awarded a grant of $2.6 million. Along with its sister organization, CHA Stem Cell Institute in Seoul, it's a non-profit unit of CHA Biotech(of Seoul). The Los Angeles unit proposes to use its grant to create stem cell lines using a process known as therapeutic cloning, or somatic cell nuclear transfer.Prop. 71 limits grants to institutions located in California, which CHA RMI appears to be. We are attempting to track down a more detailed definition of the limitation and will post it when it becomes available.
"The CHA RMI researchers will attempt to create cloned human embryos with the cellular attributes of Lou Gehrig's disease, an incurable neurological disorder. They will try to do this by combining human egg cells whose nucleus has been removed with DNA provided by adults with the disease. The scientists will then isolate and extract stem cells from the embryos.
"'We feel a great responsibility for this project and we will pursue our research with utmost efforts,' Chung Hyung Min, a professor and the director of the project at CHA Stem Cell Institute, said in a telephone interview from Seoul. "It won't be an easy project, but we're striving so that our efforts can contribute to curing Lou Gehrig's disease and many other diseases such as Parkinson's disease."
"CHA Biotech is a for-profit entity set up to coordinate the work of academic researchers and hospital physicians centered on stem cell, gene therapy and regenerative medicine technology, according to its Web site. It's part of CHA Health Systems, also called the CHA Medical Group, which owns or is affiliated with several universities, hospitals and research institutes in Korea and the U.S."
Most reporters focused on the dollars in the grants. But Jim Downing of The Sacramento Bee zeroed in on the researchers and their goals. The first two paragraphs of his story read:
"Mark Zern is trying to figure out how to grow adult human livers, more or less from scratch.Here are links to other stories and press releases issued by recipient institutions. We will carry links to other news releases from recipients as they come to our attention.
"Alice Tarantal hopes to find a way to regenerate failed kidneys."
Steve Johnson, San Jose Mercury News
Carl Hall, San Francisco Chronicle
Reporter Terri Somers, San Diego Union-Tribune
Mary Engel, Los Angeles Times
Gary Robbins, Orange Country Register
People's Daily Online
UCLA
UC San Diego
UC San Francisco
Burnham Institute
Stanford
Friday, March 16, 2007
CIRM Press Release on the Latest Grants
The following is the complete press release on the latest grants from CIRM. It should be posted shortly on the CIRM. We are posting it here because of a delay in the posting.
----------
For release: IMMEDIATE Contact: Dale A. Carlson
415/396-9117
$75 MLLION BOOST FOR CALIFORNIA STEM CELL SCIENTISTS
Assembly Speaker says California on the path to cures
State now largest source of funding for embryonic stem cell research
LOS ANGELES, March 16, 2007 – Just a month after approving nearly $45 million for embryonic stem cell research, California’s stem cell agency authorized another $75.7 million in additional funds for established scientists at 12 non-profit and academic institutions.
The 29-member Independent Citizens Oversight Committee (ICOC), governing board of the California Institute for Regenerative Medicine (CIRM), today approved 29 Comprehensive Research Grants for approximately $74.6 million over four years, to accomplished stem cell investigators at academic and non-profit research centers throughout the state. The grants were selected from 70 applications from researchers at 23 institutions, who sought more than $175 million in CIRM funding.
“This time of the year new life and new hope seem to be everywhere you look,” said Fabian Núñez, Speaker of the California State Assembly. “With these new grants, California is continuing on the path of turning the hope and promise of stem cell research into the reality of therapies and cures for millions of Californians and people across the globe. The California spirit – the perseverance, creativity and resourcefulness that has made us a leader on everything from gold mining in the 19th Century to fighting global warming in this one -- is fully present in our stem cell research teams. With today’s grants California shows we are again blazing the trail.”
Speaker Núñez joined Los Angeles Mayor Antonio Villaraigosa and Robert N. Klein, chairman of the ICOC, at a press conference to review the latest research grants.
“As of today, California is the largest and most stable source of funding for human embryonic stem cell research in the world,” Klein said. “The scientific projects proposed for our third set of grants are very strong, and it’s clear that there is an abundance of scientific opportunities for the state’s investments. We are off to an extraordinary start towards fulfilling the mandate of 7 million California voters, and the hopes of patients and families worldwide.”
The Comprehensive Grants approved today will support mature, ongoing studies on human embryonic stem cells (hESCs) by scientists with a record of accomplishment in the field. They were designed for investigators with well-developed expertise in hESC research or in a closely-related field to pursue new directions in hESCs based on their current research.
“These grants provide substantial support to a pool of very distinguished researchers in human embryonic stem cell research,” declared Zach W. Hall, Ph.D., CIRM’s President and Chief Scientific Officer. “These grants are larger than the Leon J. Thal SEED grants approved in February and extend over four years rather than two. Accordingly, our reviewers had higher expectations and more rigorous standards for judging this set of applications.
“The ICOC has approved a very well-balanced portfolio of research proposals, including those aimed at understanding stem cell differentiation and identifying new ways of obtaining hESCs, and many that target specific diseases,” Hall said. “Combined with our training and SEED grants, the CIRM is now funding embryonic stem cell research in more than 100 California laboratories.”
“We focused our initial grants on human embryonic stem cells specifically,” Klein said, “because human embryonic stem cell research receives minimal funding from the federal government, and even those funds are restricted to lines of questionable value. Going forward, we will support a diverse range of stem cell research projects. There are a number of California institutions that have strong programs in adult and other stem cells, for example, that are just beginning to build embryonic stem cell capabilities. Many of these institutions may be prominent names in future grant awards. We need them to be fully engaged in this project, if we’re going to achieve our objectives. Fortunately, we have 10 years and $3 billion to build a strong program encompassing all of California’s research institutions.”
Like the Leon J. Thal SEED grants, the Comprehensive Grants will fund a broad range of projects, including:
* A study of how chemical modification of DNA in hESCs impacts nerve formation and the ability of stem cells to repair brain damage caused by stroke (UCLA)
* Development of new ways of deriving hESCs and investigating the special capabilities of newly-derived human cell lines. (UCSF)
* A proposal to develop neural cellular models of Parkinson’s disease and Lou Gehrig’s disease (ALS) that could be used to screen chemical libraries for novel drugs and to develop preclinical models of human disease (Salk Institute)
* Building tools to better isolate heart and blood cells from differentiated populations of hESCs (Stanford)
* A proposal to optimize the creation of liver cells for transplantation, and be able to monitor their in-vivo fate non-invasively (UC Davis)
* A study of molecular mechanisms regulating hESC survival, focused on a very specific and promising class of growth factors (UC Irvine)
The ICOC approved Comprehensive Research Grants to the following researchers (Note: the dollar amounts shown are the four-year budgets requested by each applicant and are subject to review and revision by CIRM, prior to the issuance of grant awards):
Application #
Principal Investigator
Institution
Title
Amount
RC1-00100-1
Baker, Dr. Julie C
Stanford University
Functional Genomic Analysis of Chemically Defined Human Embryonic Stem Cells
$2,628,635
RC1-00104-1
Bernstein, Dr. Harold S
University of California, San Francisco
Modeling Myocardial Therapy with Human Embryonic Stem Cells
$2,229,140
RC1-00108-1
Crooks, Dr. Gay Miriam
Children's Hospital of Los Angeles
Regulated Expansion of Lympho-hematopoietic Stem and Progenitor Cells from Human Embryonic Stem Cells (hESC)
$2,551,088
RC1-00110-1
Donovan, Professor Peter
University of California, Irvine
Improved hES Cell Growth and Differentiation
$2,509,438
RC1-00111-1
Fan, Dr. Guoping
University of California, Los Angeles
Epigenetic gene regulation during the differentiation of human embryonic stem cells: Impact on neural repair
$2,516,613
RC1-00113-1
Fisher, Dr. Susan J.
University of California, San Francisco
Constructing a fate map of the human embryo
$2,532,388
RC1-00115-1
Gage, Professor Fred H.
The Salk Institute for Biological Studies
Molecular and Cellular Transitions from ES Cells to Mature Functioning Human Neurons
$2,879,210
RC1-00116-1
Goldstein, Professor Lawrence S. B.
University of California, San Diego
USING HUMAN EMBRYONIC STEM CELLS TO UNDERSTAND AND TO DEVELOP NEW THERAPIES FOR ALZHEIMER'S DISEASE
$2,512,664
RC1-00119-1
Heller, Professor Stefan
Stanford University
Generation of inner ear sensory cells from human ES cells toward a cure for deafness
$2,469,373
RC1-00123-1
Lee, Dr. Jang-Won
CHA Regenerative Medicine Institute
Establishment Of Stem Cell Lines From Somatic Cell Nuclear Transfer-Embryos in Humans
$2,556,066
RC1-00124-1
Lee, Dr. Randall James
University of California, San Francisco
Embryonic Stem Cell-Derived Therapies Targeting Cardiac Ischemic Disease
$2,524,617
RC1-00125-1
Lipton, Dr. Stuart A.
Burnham Institute for Medical Research
MEF2C-Directed Neurogenesis From Human Embryonic Stem Cells
$3,035,996
RC1-00131-1
Marsala, Dr. Martin
University of California, San Diego
Spinal ischemic paraplegia: modulation by human embryonic stem cell implant.
$2,445,716
RC1-00132-1
Mercola, Dr. Mark
Burnham Institute for Medical Research
Chemical Genetic Approach to Production of hESC-derived Cardiomyocytes
$3,036,002
RC1-00133-1
Nusse, Dr. Roel
Stanford University
Guiding the developmental program of human embryonic stem cells by isolated Wnt factors
$2,354,820
RC1-00134-1
Palmer, Professor Theo D
Stanford University
Immunology of neural stem cell fate and function
$2,501,125
RC1-00135-1
Pleasure, Dr. Samuel J.
University of California, San Francisco
Human stem cell derived oligodendrocytes for treatment of stroke and MS
$2,566,701
RC1-00137-1
Reijo Pera, Dr. Renee A.
University of California, San Francisco
Human oocyte development for genetic, pharmacological and reprogramming applications
$2,469,104
RC1-00142-1
Srivastava, Dr. Deepak
The J. David Gladstone Institutes
microRNA Regulation of Cardiomyocyte Differentiation from Human Embryonic Stem Cells
$3,164,000
RC1-00144-1
Tarantal, Professor Alice F.
University of California, Davis
Preclinical Model for Labeling, Transplant, and In Vivo Imaging of Differentiated Human Embryonic Stem Cells
$2,257,040
RC1-00148-1
Xu, Yang
University of California, San Diego
Mechanisms to maintain the self-renewal and genetic stability of human embryonic stem cells
$2,570,000
RC1-00149-1
Zack, Dr. Jerome A
University of California, Los Angeles
Human Embryonic Stem Cell Therapeutic Strategies to Target HIV Disease
$2,516,831
RC1-00151-1
Zarins, Dr. Christopher K.
Stanford University
Engineering a Cardiovascular Tissue Graft from Human Embryonic Stem Cells
$2,618,704
RC1-00345-1
Keirstead, Dr. Hans S.
University of California, Irvine
hESC-Derived Motor Neurons For the Treatment of Cervical Spinal Cord Injury
$2,396,932
RC1-00346-1
Kriegstein, Dr. Arnold R.
University of California, San Francisco
Derivation of Inhibitory Nerve Cells from Human Embryonic Stem Cells
$2,507,223
RC1-00347-1
Leavitt, Dr. Andrew D.
University of California, San Francisco
Understanding hESC-based Hematopoiesis for Therapeutic Benefit
$2,566,702
RC1-00353-1
Wallace, Professor Douglas C.
University of California, Irvine
The Dangers of Mitochondrial DNA Heteroplasmy in Stem Cells Created by Therapeutic Cloning
$2,530,000
RC1-00354-1
Weissman, Dr. Irving L
Stanford University
Prospective isolation of hESC-derived hematopoietic and cardiomyocyte stem cells
$2,636,900
RC1-00359-1
Zern, Professor Mark Allen
University of California, Davis
An in vitro and in vivo comparison among three different human hepatic stem cell populations.
$2,504,614
Total $74,587,642
Totals for each institution are listed below:
Institution
Comp Grants
Amount
UC San Francisco
7
$17,395,875
Stanford University
6
$15,209,557
UC San Diego
3
$7,528,380
UC Irvine
3
$7,436,370
Burnham Institute for Medical Research
2
$6,071,998
UCLA
2
$5,033,444
UC Davis
2
$4,761,654
The J. David Gladstone Institutes
1
$3,164,000
Salk Institute for Biological Studies
1
$2,879,210
CHA Regenerative Medicine Institute
1
$2,556,066
Children’s Hospital of Los Angeles
1
$2,551,088
Total
29
$74,587,642
The ICOC also completed its review of the Leon J. Thal SEED Grant applications. Nearly $45 million was approved in February, to 72 scientists at 20 institutions. Today the ICOC approved two additional grants to the following researchers (Note: the dollar amounts shown are the two-year budgets requested by each applicant and are subject to review and revision by CIRM, prior to the issuance of grant awards):
Application #
Principal Investigator
Institution
Title
Amount
RS1-00308-1
Stainier, Dr. Didier Y.R.
University of California, San Francisco
Endodermal differentiation of human ES cells
$635,242
RS1-00247-1
LaFerla, Dr. Frank M.
University of California, Irvine
Development of human ES cell lines as a model system for Alzheimer disease drug discovery
$492,750
Total $1,127,992
The first scientific grants approved under the Stem Cell Research and Cures Act totaled $37.5 million, and were awarded in April 2006, to train 169 pre-doctoral, post-doctoral, and clinical fellows at 16 non-profit and academic research institutions. With today’s decision, the ICOC has now approved more than $158 million for research grants at 23 California institutions:
Institution
Training Grants
SEED Grants
Comp Grants
Grants
Funds (Requested & Awarded)
Stanford University
1
12
6
19
$26,519,988
UC San Francisco
1
9
7
17
$25,796,219
UC San Diego
1
6
3
10
$14,821,287
Burnham Institute
for Medical Research
1
8
2
11
$13,381,881
UC Irvine
1
7
3
11
$13,581,435
UC Los Angeles
1
7
2
10
$12,907,906
UC Davis
1
2
2
5
$8,286,877
The J. Gladstone Institutes
1
3
1
5
$7,920,705
The Salk Institute
for Biological Studies
1
3
1
5
$6,605,126
Children's Hospital of Los Angeles
1
1
1
3
$5,578,107
University of Southern California
1
4
5
$5,405,461
UC Berkeley
1
2
3
$3,446,378
CHA Institute of Regenerative Medicine
1
1
$2,556,066
UC Santa Cruz
1
2
3
$2,132,200
California Institute of Technology
1
1
$2,071,823
The Scripps Research Institute
1
1
2
$1,836,280
UC Santa Barbara
1
1
$1,218,242
UC Riverside
2
2
$1,139,456
Buck Institute for Age Research
1
1
$734,202
Human BioMolecular Research Institute
1
1
$714,654
Ludwig Institute for Cancer Research
1
1
$691,489
UC Merced
1
1
$363,707
City of Hope, National Medical Center
1
1
$357,978
Totals
16
74
29
119
$158,067,467
About CIRM
Governed by the ICOC, CIRM was established in 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Initiative. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was approved by California voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. For more information, please visit www.cirm.ca.gov.
###
----------
For release: IMMEDIATE Contact: Dale A. Carlson
415/396-9117
$75 MLLION BOOST FOR CALIFORNIA STEM CELL SCIENTISTS
Assembly Speaker says California on the path to cures
State now largest source of funding for embryonic stem cell research
LOS ANGELES, March 16, 2007 – Just a month after approving nearly $45 million for embryonic stem cell research, California’s stem cell agency authorized another $75.7 million in additional funds for established scientists at 12 non-profit and academic institutions.
The 29-member Independent Citizens Oversight Committee (ICOC), governing board of the California Institute for Regenerative Medicine (CIRM), today approved 29 Comprehensive Research Grants for approximately $74.6 million over four years, to accomplished stem cell investigators at academic and non-profit research centers throughout the state. The grants were selected from 70 applications from researchers at 23 institutions, who sought more than $175 million in CIRM funding.
“This time of the year new life and new hope seem to be everywhere you look,” said Fabian Núñez, Speaker of the California State Assembly. “With these new grants, California is continuing on the path of turning the hope and promise of stem cell research into the reality of therapies and cures for millions of Californians and people across the globe. The California spirit – the perseverance, creativity and resourcefulness that has made us a leader on everything from gold mining in the 19th Century to fighting global warming in this one -- is fully present in our stem cell research teams. With today’s grants California shows we are again blazing the trail.”
Speaker Núñez joined Los Angeles Mayor Antonio Villaraigosa and Robert N. Klein, chairman of the ICOC, at a press conference to review the latest research grants.
“As of today, California is the largest and most stable source of funding for human embryonic stem cell research in the world,” Klein said. “The scientific projects proposed for our third set of grants are very strong, and it’s clear that there is an abundance of scientific opportunities for the state’s investments. We are off to an extraordinary start towards fulfilling the mandate of 7 million California voters, and the hopes of patients and families worldwide.”
The Comprehensive Grants approved today will support mature, ongoing studies on human embryonic stem cells (hESCs) by scientists with a record of accomplishment in the field. They were designed for investigators with well-developed expertise in hESC research or in a closely-related field to pursue new directions in hESCs based on their current research.
“These grants provide substantial support to a pool of very distinguished researchers in human embryonic stem cell research,” declared Zach W. Hall, Ph.D., CIRM’s President and Chief Scientific Officer. “These grants are larger than the Leon J. Thal SEED grants approved in February and extend over four years rather than two. Accordingly, our reviewers had higher expectations and more rigorous standards for judging this set of applications.
“The ICOC has approved a very well-balanced portfolio of research proposals, including those aimed at understanding stem cell differentiation and identifying new ways of obtaining hESCs, and many that target specific diseases,” Hall said. “Combined with our training and SEED grants, the CIRM is now funding embryonic stem cell research in more than 100 California laboratories.”
“We focused our initial grants on human embryonic stem cells specifically,” Klein said, “because human embryonic stem cell research receives minimal funding from the federal government, and even those funds are restricted to lines of questionable value. Going forward, we will support a diverse range of stem cell research projects. There are a number of California institutions that have strong programs in adult and other stem cells, for example, that are just beginning to build embryonic stem cell capabilities. Many of these institutions may be prominent names in future grant awards. We need them to be fully engaged in this project, if we’re going to achieve our objectives. Fortunately, we have 10 years and $3 billion to build a strong program encompassing all of California’s research institutions.”
Like the Leon J. Thal SEED grants, the Comprehensive Grants will fund a broad range of projects, including:
* A study of how chemical modification of DNA in hESCs impacts nerve formation and the ability of stem cells to repair brain damage caused by stroke (UCLA)
* Development of new ways of deriving hESCs and investigating the special capabilities of newly-derived human cell lines. (UCSF)
* A proposal to develop neural cellular models of Parkinson’s disease and Lou Gehrig’s disease (ALS) that could be used to screen chemical libraries for novel drugs and to develop preclinical models of human disease (Salk Institute)
* Building tools to better isolate heart and blood cells from differentiated populations of hESCs (Stanford)
* A proposal to optimize the creation of liver cells for transplantation, and be able to monitor their in-vivo fate non-invasively (UC Davis)
* A study of molecular mechanisms regulating hESC survival, focused on a very specific and promising class of growth factors (UC Irvine)
The ICOC approved Comprehensive Research Grants to the following researchers (Note: the dollar amounts shown are the four-year budgets requested by each applicant and are subject to review and revision by CIRM, prior to the issuance of grant awards):
Application #
Principal Investigator
Institution
Title
Amount
RC1-00100-1
Baker, Dr. Julie C
Stanford University
Functional Genomic Analysis of Chemically Defined Human Embryonic Stem Cells
$2,628,635
RC1-00104-1
Bernstein, Dr. Harold S
University of California, San Francisco
Modeling Myocardial Therapy with Human Embryonic Stem Cells
$2,229,140
RC1-00108-1
Crooks, Dr. Gay Miriam
Children's Hospital of Los Angeles
Regulated Expansion of Lympho-hematopoietic Stem and Progenitor Cells from Human Embryonic Stem Cells (hESC)
$2,551,088
RC1-00110-1
Donovan, Professor Peter
University of California, Irvine
Improved hES Cell Growth and Differentiation
$2,509,438
RC1-00111-1
Fan, Dr. Guoping
University of California, Los Angeles
Epigenetic gene regulation during the differentiation of human embryonic stem cells: Impact on neural repair
$2,516,613
RC1-00113-1
Fisher, Dr. Susan J.
University of California, San Francisco
Constructing a fate map of the human embryo
$2,532,388
RC1-00115-1
Gage, Professor Fred H.
The Salk Institute for Biological Studies
Molecular and Cellular Transitions from ES Cells to Mature Functioning Human Neurons
$2,879,210
RC1-00116-1
Goldstein, Professor Lawrence S. B.
University of California, San Diego
USING HUMAN EMBRYONIC STEM CELLS TO UNDERSTAND AND TO DEVELOP NEW THERAPIES FOR ALZHEIMER'S DISEASE
$2,512,664
RC1-00119-1
Heller, Professor Stefan
Stanford University
Generation of inner ear sensory cells from human ES cells toward a cure for deafness
$2,469,373
RC1-00123-1
Lee, Dr. Jang-Won
CHA Regenerative Medicine Institute
Establishment Of Stem Cell Lines From Somatic Cell Nuclear Transfer-Embryos in Humans
$2,556,066
RC1-00124-1
Lee, Dr. Randall James
University of California, San Francisco
Embryonic Stem Cell-Derived Therapies Targeting Cardiac Ischemic Disease
$2,524,617
RC1-00125-1
Lipton, Dr. Stuart A.
Burnham Institute for Medical Research
MEF2C-Directed Neurogenesis From Human Embryonic Stem Cells
$3,035,996
RC1-00131-1
Marsala, Dr. Martin
University of California, San Diego
Spinal ischemic paraplegia: modulation by human embryonic stem cell implant.
$2,445,716
RC1-00132-1
Mercola, Dr. Mark
Burnham Institute for Medical Research
Chemical Genetic Approach to Production of hESC-derived Cardiomyocytes
$3,036,002
RC1-00133-1
Nusse, Dr. Roel
Stanford University
Guiding the developmental program of human embryonic stem cells by isolated Wnt factors
$2,354,820
RC1-00134-1
Palmer, Professor Theo D
Stanford University
Immunology of neural stem cell fate and function
$2,501,125
RC1-00135-1
Pleasure, Dr. Samuel J.
University of California, San Francisco
Human stem cell derived oligodendrocytes for treatment of stroke and MS
$2,566,701
RC1-00137-1
Reijo Pera, Dr. Renee A.
University of California, San Francisco
Human oocyte development for genetic, pharmacological and reprogramming applications
$2,469,104
RC1-00142-1
Srivastava, Dr. Deepak
The J. David Gladstone Institutes
microRNA Regulation of Cardiomyocyte Differentiation from Human Embryonic Stem Cells
$3,164,000
RC1-00144-1
Tarantal, Professor Alice F.
University of California, Davis
Preclinical Model for Labeling, Transplant, and In Vivo Imaging of Differentiated Human Embryonic Stem Cells
$2,257,040
RC1-00148-1
Xu, Yang
University of California, San Diego
Mechanisms to maintain the self-renewal and genetic stability of human embryonic stem cells
$2,570,000
RC1-00149-1
Zack, Dr. Jerome A
University of California, Los Angeles
Human Embryonic Stem Cell Therapeutic Strategies to Target HIV Disease
$2,516,831
RC1-00151-1
Zarins, Dr. Christopher K.
Stanford University
Engineering a Cardiovascular Tissue Graft from Human Embryonic Stem Cells
$2,618,704
RC1-00345-1
Keirstead, Dr. Hans S.
University of California, Irvine
hESC-Derived Motor Neurons For the Treatment of Cervical Spinal Cord Injury
$2,396,932
RC1-00346-1
Kriegstein, Dr. Arnold R.
University of California, San Francisco
Derivation of Inhibitory Nerve Cells from Human Embryonic Stem Cells
$2,507,223
RC1-00347-1
Leavitt, Dr. Andrew D.
University of California, San Francisco
Understanding hESC-based Hematopoiesis for Therapeutic Benefit
$2,566,702
RC1-00353-1
Wallace, Professor Douglas C.
University of California, Irvine
The Dangers of Mitochondrial DNA Heteroplasmy in Stem Cells Created by Therapeutic Cloning
$2,530,000
RC1-00354-1
Weissman, Dr. Irving L
Stanford University
Prospective isolation of hESC-derived hematopoietic and cardiomyocyte stem cells
$2,636,900
RC1-00359-1
Zern, Professor Mark Allen
University of California, Davis
An in vitro and in vivo comparison among three different human hepatic stem cell populations.
$2,504,614
Total $74,587,642
Totals for each institution are listed below:
Institution
Comp Grants
Amount
UC San Francisco
7
$17,395,875
Stanford University
6
$15,209,557
UC San Diego
3
$7,528,380
UC Irvine
3
$7,436,370
Burnham Institute for Medical Research
2
$6,071,998
UCLA
2
$5,033,444
UC Davis
2
$4,761,654
The J. David Gladstone Institutes
1
$3,164,000
Salk Institute for Biological Studies
1
$2,879,210
CHA Regenerative Medicine Institute
1
$2,556,066
Children’s Hospital of Los Angeles
1
$2,551,088
Total
29
$74,587,642
The ICOC also completed its review of the Leon J. Thal SEED Grant applications. Nearly $45 million was approved in February, to 72 scientists at 20 institutions. Today the ICOC approved two additional grants to the following researchers (Note: the dollar amounts shown are the two-year budgets requested by each applicant and are subject to review and revision by CIRM, prior to the issuance of grant awards):
Application #
Principal Investigator
Institution
Title
Amount
RS1-00308-1
Stainier, Dr. Didier Y.R.
University of California, San Francisco
Endodermal differentiation of human ES cells
$635,242
RS1-00247-1
LaFerla, Dr. Frank M.
University of California, Irvine
Development of human ES cell lines as a model system for Alzheimer disease drug discovery
$492,750
Total $1,127,992
The first scientific grants approved under the Stem Cell Research and Cures Act totaled $37.5 million, and were awarded in April 2006, to train 169 pre-doctoral, post-doctoral, and clinical fellows at 16 non-profit and academic research institutions. With today’s decision, the ICOC has now approved more than $158 million for research grants at 23 California institutions:
Institution
Training Grants
SEED Grants
Comp Grants
Grants
Funds (Requested & Awarded)
Stanford University
1
12
6
19
$26,519,988
UC San Francisco
1
9
7
17
$25,796,219
UC San Diego
1
6
3
10
$14,821,287
Burnham Institute
for Medical Research
1
8
2
11
$13,381,881
UC Irvine
1
7
3
11
$13,581,435
UC Los Angeles
1
7
2
10
$12,907,906
UC Davis
1
2
2
5
$8,286,877
The J. Gladstone Institutes
1
3
1
5
$7,920,705
The Salk Institute
for Biological Studies
1
3
1
5
$6,605,126
Children's Hospital of Los Angeles
1
1
1
3
$5,578,107
University of Southern California
1
4
5
$5,405,461
UC Berkeley
1
2
3
$3,446,378
CHA Institute of Regenerative Medicine
1
1
$2,556,066
UC Santa Cruz
1
2
3
$2,132,200
California Institute of Technology
1
1
$2,071,823
The Scripps Research Institute
1
1
2
$1,836,280
UC Santa Barbara
1
1
$1,218,242
UC Riverside
2
2
$1,139,456
Buck Institute for Age Research
1
1
$734,202
Human BioMolecular Research Institute
1
1
$714,654
Ludwig Institute for Cancer Research
1
1
$691,489
UC Merced
1
1
$363,707
City of Hope, National Medical Center
1
1
$357,978
Totals
16
74
29
119
$158,067,467
About CIRM
Governed by the ICOC, CIRM was established in 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Initiative. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was approved by California voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. For more information, please visit www.cirm.ca.gov.
###
Correction
In the item below, we incorrectly reported that 24 grants were approved. In fact, the number is 29.
Thursday, March 15, 2007
CIRM Hands Out Nearly $75 Million in Stem Cell Grants
The California stem cell agency Thursday night approved $74.6 million in embryonic stem cell research grants that could have an impact on medical problems ranging from Alzheimer's to deafness.
The 29 grants that were approved were contained in the first tier of those recommended by CIRM's review committee. The funding requests were approved by the Oversight Committee in a single block on a single vote.
Robert Klein, chair of the institute, said that the funding, combined with other grants, ranks California at the top of sources for embryonic stem cell research funding in the world. By the middle of this year, the institute expects to have given away something on the order of $200 million or more to beef up ESC research.
CIRM has called a news conference for Friday morning to announce the grants, bolstered by the presence of the mayor of Los Angeles and the state's top legislative leader.
(Editor's note: An earlier version of this item said 24 grants were approved. The correct number is 29.)
The 29 grants that were approved were contained in the first tier of those recommended by CIRM's review committee. The funding requests were approved by the Oversight Committee in a single block on a single vote.
Robert Klein, chair of the institute, said that the funding, combined with other grants, ranks California at the top of sources for embryonic stem cell research funding in the world. By the middle of this year, the institute expects to have given away something on the order of $200 million or more to beef up ESC research.
CIRM has called a news conference for Friday morning to announce the grants, bolstered by the presence of the mayor of Los Angeles and the state's top legislative leader.
(Editor's note: An earlier version of this item said 24 grants were approved. The correct number is 29.)
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