Christopher Thomas Scott, the executive director of the Program on Stem Cells in Society at Stanford, sent the following along. He wrote it in the form of a letter to the editor after reading an op-ed piece on embryonic stem cell research in the Wall Street Journal last week.
"Dear Editors:
"It was familiar a twist in the gut. Robert George and Thomas Berg's "Six Stem Cell Facts" (March 14 Wall Street Journal) provoked the usual response: Should I write 1) a trenchant rejoinder (Six Stem Cell Lies) 2) a carefully crafted counter argument, or 3) lie in wait and pounce in the pages of another newspaper?
"I was up Thursday before dawn. I poured myself a cold, frothy tumbler of bile, and sat down to write.
"Nothing happened.
"I was mystified--George and Berg's essay was an easy target, trotting out old moral and religious tropes.
"It took me a few days to figure it out, but now I understand this odd ennui. Supporters of embryonic stem cell research, including those of us who battle in journals and newspapers, have moved on. Embryonic stem cell research has left the barn, as the saying goes, and now we're getting on with the important stuff--the business of discovery, treatments and cures--what America does better than any other.
"This leaves commentators like George, Berg, and Krauthammer all alone, caterwauling and swinging roundhouses into thin air. The ringside seats are nearly empty. The images of dismemberment (as if an itoa of cells has arms and legs) or Krauthammer's lovely description in sanctioned government reports of "fetuses hanging on meathooks" has become a rhetorical sideshow, better suited for circus barkers. Will they join us at the edge of medicine's most promising frontier, where new, nuanced debates about stem cell therapies are taking shape? Or will they remain behind, shouting into the wind?"
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
Fresh Comment Update
Jonathan Eisen has added more commentary on the openness of the CIRM grant system. See "comments" on "Sunburn" below. Lawrence Ebert has more on the issue of "hidden economic interests" in New Jersey research. See "Fresh Comments" below.
As a point of information, we have started these comments advisories in an effort to bring more attention to the contributions of those who take the time to add to this dialogue. These manual comment updates are a bit clunky but we are looking for a sleek, hotsy-totsy way of providing them automatically in a separate space on this page. If you have any suggestions for finding a nifty HTML tool that will do that, send it along. Meanwhile, as general guidance, it would be better to post comments on the items dealing with the subject matter as opposed to posting them on these advisories on comments being posted.
Keep the stuff coming. Thanks to all.
As a point of information, we have started these comments advisories in an effort to bring more attention to the contributions of those who take the time to add to this dialogue. These manual comment updates are a bit clunky but we are looking for a sleek, hotsy-totsy way of providing them automatically in a separate space on this page. If you have any suggestions for finding a nifty HTML tool that will do that, send it along. Meanwhile, as general guidance, it would be better to post comments on the items dealing with the subject matter as opposed to posting them on these advisories on comments being posted.
Keep the stuff coming. Thanks to all.
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."
CGS: CIRM Grant Recipient Has 'Shadowed' History
The Center for Genetics and Society today said "troubling questions" have arisen in connection with California's $2.6 million stem cell research grant to CHA RMI, adding another voice to the call for an investigation.
Marcy Darnovsky, associate director of the Oakland-based center, said in a press release:
We have asked CHA for comment on these matters and will carry them when we receive them.
The center's press release was not posted on the Internet at the time of this writing. We will carry an advisory when it is posted.
Marcy Darnovsky, associate director of the Oakland-based center, said in a press release:
"The leadership of CHA Health Systems (a Korean firm) has a shadowed recent history, including a lawsuit that alleges the director of its fertility center lied in order to obtain a woman’s eggs, The CIRM needs to live up to its oft-stated commitments to transparency and responsibility by freezing this multi-million dollar award while a thorough investigation is undertaken. If questions cannot be satisfactorily answered, the grant should be rescinded.”Jesse Reynolds, a policy analyst at CGS and who has attended many CIRM meetings, said:
"Did CHA Health Systems establish this subsidiary in order to pursue California public funding, at a time when South Korea government funds were unavailable because of the Hwang Woo Suk cloning scandal? Given the recent record of unethical conduct in this field, the CIRM should have known to exercise greater scrutiny."The press release continued:
"The medical director of the CHA Fertility Center is the subject of a lawsuit filed by a woman who says that he lied about the number of eggs that had been collected from her, causing her to continue seeking treatment from him. The CHA Fertility Center and the CHA Regenerative Medicine Institute are located in the same Los Angeles office building.Asked for a comment, Dale Carlson, chief communications officer for CIRM, said CGS' comments were "another uninformed reaction." He used similar language concerning statements by the Foundation for Taxpayer and Consumers Rights.
"'The lawsuit suggests that CHA’s leadership placed a woman at unnecessary risk by misleading her into undergoing repeated cycles of egg retrieval,' Darnovsky said. 'Women’s health advocates have warned about the health risks of egg retrieval, as well as about likely conflicts of interest between fertility doctors conducting egg retrieval and researchers who want the eggs for their experiments.'"
We have asked CHA for comment on these matters and will carry them when we receive them.
The center's press release was not posted on the Internet at the time of this writing. We will carry an advisory when it is posted.
FTCR Calls for Investigation Into California Stem Cell Grant
A California watchdog group has asked the state's stem cell research agency to investigate a Korean-linked organization that the agency approved last week for a $2.6 million grant.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said in a press release that CIRM's "secretive awards process let a questionable $2.6 million grant slip by the Oversight Committee without adequate scrutiny."
His comment came today following a report Wednesday on the California Stem Cell Report concerning the recipient of the grant, CHA RMI, and Kwang-Yul Cha, chief executive of the parent company of CHA RMI.
In a letter to the CIRM, Simpson said:
Simpson said in the press release:
Simpson also said,
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said in a press release that CIRM's "secretive awards process let a questionable $2.6 million grant slip by the Oversight Committee without adequate scrutiny."
His comment came today following a report Wednesday on the California Stem Cell Report concerning the recipient of the grant, CHA RMI, and Kwang-Yul Cha, chief executive of the parent company of CHA RMI.
In a letter to the CIRM, Simpson said:
"It is not clear what (CHA RMI's) affiliation is with its corporate parents CHA Medical, CHA Biotech and other corporate for-profit entities. Kwang-Yul Cha is the chief executive of CHA Health Systems, chairman of Hollywood Presbyterian Medical Center and director of CHA Regenerative Medicine Institute. Is CHA RMI truly a non-profit institution eligible for funding in this round of grants?"Simpson also said "serious questions" have been raised about Cha in connection with plagiarism allegations along with a state inquiry into whether he was violating the law by using MD after his name when he is not licensed to practice medicine in California.
Simpson said in the press release:
"We’ve argued that the process should be open and the applicants identified as they do in Connecticut. The stem cell institute refused to let the sun shine in and they got burned as a result."In response to our query, Dale Carlson, chief communications officer for CIRM, said,
"Simpson appears to be uninformed about the grant review process, here and at other agencies."We have asked Cha for a comment and will carry it when we receive it.
Simpson also said,
"I'm grateful the California Stem Cell Report first linked the CHA Regenerative Medicine Institute to the problems in its affiliates. Without David Jensen's digging this would likely have slipped by us all."
More on Plagiarism, Prayer and Cha
Patent attorney Lawrence Ebert has posted details concerning Kwang-Yul Cha, whose subsidiary has won a $2.6 million California stem cell grant, and Cha's "anonymous prayer" paper in The Journal of Reproductive Medicine.
Writing on his Ipbiz site, Ebert said:
Writing on his Ipbiz site, Ebert said:
"One co-author is a convicted felon, one co-author has had his name removed, but JRM won't retract it."Ebert also had more details on the plagiarism issue from The Scientist magazine.
"Fertility and Sterility has censured the authors(including Cha) of a 2005 article after learning a Korean journal had published the identical paper one year earlier. The Fertility and Sterility authors also left off the name of Jeong-Hwan Kim, who was listed as the first author on the Korean paper and performed the bulk of the research reported in both papers."The Scientist piece continued:
"The journal will also issue a note in an upcoming issue describing the transgression, and has barred every author listed on the original Fertility and Sterility paper from contributing papers to the journal for three years, editor Alan DeCherney told The Scientist. 'This is a serious punishment.'"
Fresh Comments
Lawrence Ebert has posted a new comment on the CHA item below. "Faye" has posted a comment on "hidden economic interests" on the "Fresh Comment" post from 3/20/07.
Wednesday, March 21, 2007
CIRM Grant Recipient Tied to Korean Scientist Involved in Plagiarism Controversy
A Los Angeles organization that is scheduled to receive a $2.6 million research grant from the California stem cell agency is a subsidiary of a Korean enterprise headed by a scientist who is enmeshed in an international plagiarism dispute.
The scientist is Kwang-Yul Cha, who also "came under criticism a few years ago for his involvement in a study suggesting that anonymous prayers from strangers might double a woman's chances of fertility," according to the Los Angeles Times.
His firm, CHA Health Systems, is the parent company of CHA Regenerative Medicine Institute (CHA RMI) of Los Angeles, a non-profit organization that last week was awarded the research grant by the Oversight Committee of the California Institute for Regenerative Medicine. The funds were approved by the 29-member committee with no specific discussion of the CHA grant. The names of the organizations were not disclosed until hours after the vote.
The information about Cha's background was first published in the Los Angeles Times Feb. 18, nearly a month before the grant was approved. The story by Charles Ornstein said Cha, whose firm also owns Hollywood Presbyterian Medical Center,
We have queried both CIRM and CHA's organization in Korea for a comment and will carry them when we receive them.
Responding to a query from the California Stem Cell Report, John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights in Santa Monica, said:
The Los Angeles Times carried a brief story on the grants, mentioning CHA by name but with no further background. Both Los Angeles Mayor Antonio Villaraigosa and California State Assembly Speaker Fabian Nunez hailed the grants generally at a news conference, but did not mention CHA specifically.
The CIRM grants are subject to administrative review before the checks go out. That includes the legal standing of applicant institutions, the status of the principal research investigators, among other things.
The scientist is Kwang-Yul Cha, who also "came under criticism a few years ago for his involvement in a study suggesting that anonymous prayers from strangers might double a woman's chances of fertility," according to the Los Angeles Times.
His firm, CHA Health Systems, is the parent company of CHA Regenerative Medicine Institute (CHA RMI) of Los Angeles, a non-profit organization that last week was awarded the research grant by the Oversight Committee of the California Institute for Regenerative Medicine. The funds were approved by the 29-member committee with no specific discussion of the CHA grant. The names of the organizations were not disclosed until hours after the vote.
The information about Cha's background was first published in the Los Angeles Times Feb. 18, nearly a month before the grant was approved. The story by Charles Ornstein said Cha, whose firm also owns Hollywood Presbyterian Medical Center,
"...is listed as the primary author on a medical paper that appeared in December 2005 in the U.S. medical journal Fertility and Sterility.Ornstein continued:
"But that paper appears to be nearly a paragraph-for-paragraph, chart-for-chart copy of a junior researcher's doctoral thesis, which appeared in a Korean medical journal nearly two years earlier, according to a Times review of both papers and the findings of a Korean medical society.
"Cha has denied any wrongdoing."
"Cha also appears to be violating state law by using MD after his name on websites and in news releases in California. He is not licensed to practice in the state, records show. His resume says he received his medical training in South Korea.On Feb. 28, Ornstein also reported that Thomas Kim, the medical director of another CHA organization, the CHA Fertility Center in Los Angeles, was under investigation by the state Medical Board "over a patient's allegations that the doctor seduced her into a lengthy sexual relationship and then lied to her about her treatment." Kim's lawyer has denied he did anything wrong and said that it was a consensual personal relationship involving Kim and the woman.
"'We don't believe it's lawful for him to hold himself out in this manner,' said Candis Cohen, a spokeswoman for the Medical Board of California."
We have queried both CIRM and CHA's organization in Korea for a comment and will carry them when we receive them.
Responding to a query from the California Stem Cell Report, John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights in Santa Monica, said:
"It strikes me that there are enough doubts about the credibility of the leadership of the CHA Medical Group so as to warrant a serious investigation before any money is transferred to its researchers.The grant to CHA RMI was part of a package that was voted on last Thursday night as a block. They had been recommended for approval by a group of out-of-state scientists and some members of the Oversight Committee, who together privately reviewed the grants some time ago. But the names of the applicants and their institutions were withheld from other members of the Oversight Committee and the public when they came up for the final vote. The Oversight Committee includes the deans of both the UCLA andUSC medical schools as well as a member of the board of the Cedars-Sinai Medical Center in Los Angeles, where the committee's meeting took place. Other prominent California medical school deans also sit on the Oversight Committee.
"First, CIRM ought to determine the relationship between the for-profit corporate parent and the non-profit CHA Regenerative Medicine Institute. It's not at all clear that CHA Regenerative Medicine is truly a non-profit organization.
"Second, the CHA Biotech website says that the institute has received approval from the Western Institutional Review Board for stem cell research involving frozen human eggs. Under CIRM rules there needs also to be approval by a SCRO committee -- Stem Cell Review Oversight committee. It's not clear that has happened. It's also important to know the source of the frozen eggs."
"Given the track record of CHA's leadership, I'd say CIRM needs to ask some tough questions and not release funds until there is a satisfactory public explanation of what's going on."
The Los Angeles Times carried a brief story on the grants, mentioning CHA by name but with no further background. Both Los Angeles Mayor Antonio Villaraigosa and California State Assembly Speaker Fabian Nunez hailed the grants generally at a news conference, but did not mention CHA specifically.
The CIRM grants are subject to administrative review before the checks go out. That includes the legal standing of applicant institutions, the status of the principal research investigators, among other things.
Fresh Comment
Jonathan Eisen has just posted a comment on the "Sunburn" item below. Click on "comment" at the end of the Sunburn posting to view Eisen's remarks.
Nature Warns of Sunburn; UC Davis Scientist Warns of Hidden Agendas
Amidst the hoopla about the latest research giveaway by the California stem cell agency, a couple of news items popped up that dealt with openness and conflicts of interests.
Last week Nature magazine editorialized that CIRM was amply open. And on Sunday, the agency itself disputed a Sacramento Bee editorial that suggested CIRM is "on thin legal ice" because it does not require its grant reviewers to publicly disclose their financial interests. But first the Nature editorial, which ironically is not accessible to the general public. It says, among other things,
Stuart Leavenworth, an associate editor at The Sacramento Bee, noted in an email to the California Stem Cell Report that the magazine's position did not surprise him "given that Nature has steadfastly refused to disclose the conflicts of interest of its authors, unlike other journals." He pointed to statements by the Center in the Public Interest and more than 30 scientists that Nature does not "reliably" disclose its authors' financial ties to drug and biotechnology companies.
The Nature editorial also surfaced on the "egghead" blog at UC Davis.
Jonathan Eisen, a professor at the UC Davis Genome Center, said, in part:
With all due respect, we suggest that the key issue has not been fully litigated. At the time of the trial cited by Carlson, CIRM had only made a small number of grants. A track record simply did not exist on whether the grant reviewers were making de facto decisions. There is no doubt, however, that the Oversight Committee has final authority on making grants.
The fundamental question about public disclosure of the financial interests of the grant reviewers concerns good public policy and openness. Should the public should be allowed to know the financial interests of those who recommend that millions of public dollars be handed out to scientists? Along with that goes the question of whether the public should be allowed to know the names of persons and institutions seeking millions of dollars in research grants.
Our position is that the interests of the science community come after the interests of the public. Unwarranted secrecy in the grant-making process only feeds suspicion and creates the possibility of insider dealings, which are not likely to be healthy for science or stem cell cures. As Eisen notes above, hidden agendas can often come into play.
(Editor's note: If you are interested in the full text of the Nature editorial, please send us a note at djensen@californiastemcellreport.com.)
Last week Nature magazine editorialized that CIRM was amply open. And on Sunday, the agency itself disputed a Sacramento Bee editorial that suggested CIRM is "on thin legal ice" because it does not require its grant reviewers to publicly disclose their financial interests. But first the Nature editorial, which ironically is not accessible to the general public. It says, among other things,
"Calls for yet more openness may be well intentioned, but they threaten to override the element of confidentiality that is inherent to fair peer review, and to undercut the agency’s mission of supporting cutting-edge research from the best Californian scientists. There comes a point at which yet more sunshine leads to sunburn."Nature also said that requiring identification of those who do not receive grants
"...would be akin to the state of California publicly releasing information on all the job applications it receives, complete with adverse comments made during the hiring process. "We could not disagree more. Seeking millions of dollars in state funds with no promise of economic return, which is what the research grants are all about, is fundamentally different than applying for a position as a state park ranger.
Stuart Leavenworth, an associate editor at The Sacramento Bee, noted in an email to the California Stem Cell Report that the magazine's position did not surprise him "given that Nature has steadfastly refused to disclose the conflicts of interest of its authors, unlike other journals." He pointed to statements by the Center in the Public Interest and more than 30 scientists that Nature does not "reliably" disclose its authors' financial ties to drug and biotechnology companies.
The Nature editorial also surfaced on the "egghead" blog at UC Davis.
Jonathan Eisen, a professor at the UC Davis Genome Center, said, in part:
"While I can see (Nature's) points, I am not sure they are the most objective place to look for for ideas on this issue. The question to me is not whether too much sunshine MIGHT cause sunburn it is whether just the risk of sunburn is worth keeping things closed. I think in this case I probably agree that the review of these proposals might be changed if it were an open review system. But as someone who has served on many grant review panels, I know that there are ALL sorts of hidden agendas that play out in the review. If review were completely open, at least these hidden agendas would be exposed to the world. Yes, some reviewers might be too timid in their reviews, but this openness would eliminate so many other problems inherent in anonymous review. This is why there are a few journals out there that now have open review of papers — something I think is certainly worth testing out."Dale Carlson, chief communications officer for CIRM, wrote the op-ed piece that challenged The Bee's position. He said that grants are not in jeopardy and that two courts have upheld the legality of CIRM's actions. Carlson referred to lawsuits that that have unsuccessfully challenged the constitutionality of the agency.
With all due respect, we suggest that the key issue has not been fully litigated. At the time of the trial cited by Carlson, CIRM had only made a small number of grants. A track record simply did not exist on whether the grant reviewers were making de facto decisions. There is no doubt, however, that the Oversight Committee has final authority on making grants.
The fundamental question about public disclosure of the financial interests of the grant reviewers concerns good public policy and openness. Should the public should be allowed to know the financial interests of those who recommend that millions of public dollars be handed out to scientists? Along with that goes the question of whether the public should be allowed to know the names of persons and institutions seeking millions of dollars in research grants.
Our position is that the interests of the science community come after the interests of the public. Unwarranted secrecy in the grant-making process only feeds suspicion and creates the possibility of insider dealings, which are not likely to be healthy for science or stem cell cures. As Eisen notes above, hidden agendas can often come into play.
(Editor's note: If you are interested in the full text of the Nature editorial, please send us a note at djensen@californiastemcellreport.com.)
Monday, March 19, 2007
Zerhouni to Bush: Nation Better Served Without Research Restrictions
The head of the National Institutes of Health, an appointee of President Bush, today defied his boss and said the president's policy on embryonic stem cell research was ill-serving the nation.
The statement came from Elias Zerhouni and was reported by Angela Zimm and Neil Roland on Bloomberg.com. They covered a Senate hearing on funding for the NIH. They wrote that Zerhouni said:
The statement came from Elias Zerhouni and was reported by Angela Zimm and Neil Roland on Bloomberg.com. They covered a Senate hearing on funding for the NIH. They wrote that Zerhouni said:
"The current lines will not be sufficient. It's not possible for me to see how we can sustain the momentum of research."Zerhouni continued:
"It's clear that American science and the nation will be better served if we have access to more cell lines."According to Bloomberg, this is the context of the remarks.
"Senator Tom Harkin, an Iowa Democrat, asked Zerhouni, whether lifting the restrictions would have an effect on finding new cures.Zerhouni could have said the same thing several years ago. But Bush is now a clearly a lame duck and on the ropes with the American public. And Zerhouni has his own future to consider. Being a handmaiden to Bush's stem cell policy is not the best position for someone who may be casting about for a new line of work.
"'The answer is yes,' Zerhouni said. The exchange came at a hearing of the Senate Appropriations subcommittee on Labor, Health and Human Services and Education."
Sunday, March 18, 2007
Beyond $131 Million: Looking Ahead at CIRM
You could call it the pipeline and presidency issue. Even before the directors of California's stem cell agency approved an unprecedented $75 million in grants, some of them were worrying about what happens next.
Brian Henderson, dean of the USC medical school, told his fellow members on the CIRM Oversight Committee, "We do not want to congratulate ourselves too much."
CIRM, however, does have something to congratulate itself about, as Los Angeles Mayor Antonio Villaraigosa reminded them during a Friday morning news conference. "Put a smile on your face," he said.
CIRM has pumped out $131 million in grants so far this year, making it clearly the largest single source of embryonic stem cell research funding in the world. More millions will come later this year. And before the end of the year, with a little luck, they will see even bigger bucks flowing in through the sale of state bonds that have been delayed because of litigation.
However, the 22-member staff of the agency has been working extraordinarily long hours. "Heroic" was a word that came up often during last week's two-day meetings to describe the work of the staff. One example that was cited was the case of one staffer, who was up until 4 a.m. readying documents for the first day of the meetings. While that may be a tad exceptional, Oversight Committee members for some time have expressed concern about the workload of the agency.
As Michael Friedman, president of the City of Hope, put it last week, the agency has been sprinting, and "we are in for a marathon."
The "challenges" facing CIRM include the loss of President Zach Hall in June, the search for his successor, the void until the new president comes aboard and the need to fill the pipeline with more grants as well as administering the ones already approved.
Several board members said momentum needs to be maintained to provide opportunities for the new scientists that have been arriving in California to tap CIRM's $3 billion research effort. They urged Hall to fill staff positions as rapidly as possible to maintain the workflow. "Please don't scrimp," Friedman said.
CIRM is not likely to have a new president on board by the time Hall leaves, which will accentuate the normal uncertainty that arises with the arrival of new CEOs, especially in small, new organizations. However, something of a model exists for working through that period. Hall will take a vacation this month and has designated two persons to act in his stead, Arlene Chiu, scientific program director, on scientific matters and Lorraine Hoffman, chief financial officer, on other issues. How they fulfill their responsibilities will be a good test for June and later in the summer.
The 29 members of the Oversight Committee hold an important key to CIRM stability and momentum. They should curb their micro-management urges, some of which are possessed in abundance by some members of the board, and focus on filling the presidency as quickly as possible. Twenty-nine busy fingers in the CIRM pie are likely to leave a pretty mess.
Henderson and the others are right to worry about a letdown, which can easily happen during or following periods of intense effort, which has been the story since January 2005. Avoiding a letdown and leaving a healthy organization may be one of Hall's most important tasks in the next few months. But much of the burden will fall on senior CIRM management, the folks who will ride through the transition. After all, they are the ones who will be left to engineer the giveaway of a piddling $2.8 billion or so over the next 10 years.
Brian Henderson, dean of the USC medical school, told his fellow members on the CIRM Oversight Committee, "We do not want to congratulate ourselves too much."
CIRM, however, does have something to congratulate itself about, as Los Angeles Mayor Antonio Villaraigosa reminded them during a Friday morning news conference. "Put a smile on your face," he said.
CIRM has pumped out $131 million in grants so far this year, making it clearly the largest single source of embryonic stem cell research funding in the world. More millions will come later this year. And before the end of the year, with a little luck, they will see even bigger bucks flowing in through the sale of state bonds that have been delayed because of litigation.
However, the 22-member staff of the agency has been working extraordinarily long hours. "Heroic" was a word that came up often during last week's two-day meetings to describe the work of the staff. One example that was cited was the case of one staffer, who was up until 4 a.m. readying documents for the first day of the meetings. While that may be a tad exceptional, Oversight Committee members for some time have expressed concern about the workload of the agency.
As Michael Friedman, president of the City of Hope, put it last week, the agency has been sprinting, and "we are in for a marathon."
The "challenges" facing CIRM include the loss of President Zach Hall in June, the search for his successor, the void until the new president comes aboard and the need to fill the pipeline with more grants as well as administering the ones already approved.
Several board members said momentum needs to be maintained to provide opportunities for the new scientists that have been arriving in California to tap CIRM's $3 billion research effort. They urged Hall to fill staff positions as rapidly as possible to maintain the workflow. "Please don't scrimp," Friedman said.
CIRM is not likely to have a new president on board by the time Hall leaves, which will accentuate the normal uncertainty that arises with the arrival of new CEOs, especially in small, new organizations. However, something of a model exists for working through that period. Hall will take a vacation this month and has designated two persons to act in his stead, Arlene Chiu, scientific program director, on scientific matters and Lorraine Hoffman, chief financial officer, on other issues. How they fulfill their responsibilities will be a good test for June and later in the summer.
The 29 members of the Oversight Committee hold an important key to CIRM stability and momentum. They should curb their micro-management urges, some of which are possessed in abundance by some members of the board, and focus on filling the presidency as quickly as possible. Twenty-nine busy fingers in the CIRM pie are likely to leave a pretty mess.
Henderson and the others are right to worry about a letdown, which can easily happen during or following periods of intense effort, which has been the story since January 2005. Avoiding a letdown and leaving a healthy organization may be one of Hall's most important tasks in the next few months. But much of the burden will fall on senior CIRM management, the folks who will ride through the transition. After all, they are the ones who will be left to engineer the giveaway of a piddling $2.8 billion or so over the next 10 years.
Telling Tales and Salvation
It has not exactly been the tales of "1,001 Arabian Nights." But last week we did post our 1,001st item on the California Stem Cell Report.
Scheherezade, the narrator of "The Book of One Thousand and One Nights," spun her stories to avoid being executed by the evil Sultan. As she put it, "Is it possible that by telling these tales, one might indeed save one's self."
However, in the case of the 1,001 stories on the California Stem Cell Report, I am more reminded of the saying about the talking dog. So what if he talks, what does he have to say?
That is a matter for all of you -- our much-appreciated readers -- to determine. Cheers to you all.
Scheherezade, the narrator of "The Book of One Thousand and One Nights," spun her stories to avoid being executed by the evil Sultan. As she put it, "Is it possible that by telling these tales, one might indeed save one's self."
However, in the case of the 1,001 stories on the California Stem Cell Report, I am more reminded of the saying about the talking dog. So what if he talks, what does he have to say?
That is a matter for all of you -- our much-appreciated readers -- to determine. Cheers to you all.
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
Grant Press Release Now on CIRM Web Site
The news release on the CIRM grants is now available on its web site so you don't have fight your way through the formating issues in the item below. Here is the link.
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.
###
Two SEED Grants Approved
The California stem cell agency Friday approved two SEED grants left over from last month's session. They were were numbers 308 and 247, by Didier Stanier from UC San Francisco and from Frank LaFerla of UC Irvine.
CIRM has prepared a press release on the awards that should be posted shortly on its web site, www.cirm.ca.gov.
CIRM has prepared a press release on the awards that should be posted shortly on its web site, 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.)
Wednesday, March 14, 2007
Chiropractors, CIRM and Its Legislative Posture
The 120 men and women who sit in the California Legislature generally tend to think they have prime responsibility for writing the laws that govern the state. And they often get edgy when state agencies, even ones that have special constitutional status, seem to be straying from the governmental straight and narrow.
Such was the case recently with the California's chiropractic board, which is enshrined in the State Constitution. Gov. Arnold Schwarzenegger's appointees to the board became carried away in what a deputy attorney general described as a fit of "lawlessness." Now the board faces a serious legislative investigation that could include elimination of its $3 million budget.
While this is something of a minor tempest – although not for chiropractors -- the chiropractic board shares several things in common with California's much heftier, $3 billion stem cell agency. Both are written into the State Constitution. Both were created by initiative. Both have issues involving conflicts of interest. And both function in near obscurity except when they hand out buckets of money – in the case of the stem cell agency – or when a scandal erupts, as in the case of chiropractic board.
Obviously major differences exist between the two boards, including the quality of the appointees. But the case of the chiropractors illustrates how quickly matters can go awry in an insular agency and how quickly the legislature may move to step in. The case will also probably show how quickly the governor can put distance between himself and what The Sacramento Bee called a "laughingstock."
Last Sunday we discussed the sometimes acrimonious relationship between CIRM and the California legislature, particularly in the light of bipartisan legislation by the chair of the Senate Health Committee, Sen. Sheila Kuehl, D-Santa Monica. Her measure would inject the legislature into the difficult and touchy matter of how the stem cell agency decides to share the potentially enormous wealth from cures developed with state-funded research. After a shaky start with lawmakers, CIRM has moved to improve its legislative relations and keep lawmakers well informed.
Our piece, which appeared as an op-ed in The Sacramento Bee, was necessarily limited because of space. But we wanted to share more that we heard from CIRM and two longtime observers of the agency, who also have been critical of its performance from time to time and sometimes even more often. What follows are virtually verbatim comments.
First, from Dale Carlson, chief communications officer for the stem cell agency:
Carlson said it was a "detailed discussion of our IP policies, the drug/therapy development process and the extensive public process we've followed."
Jesse Reynolds, project director on biotechnology accountability for the Center for Genetics and Society in Oakland, has followed CIRM closely during the last two years as well as the Prop. 71 campaign.
Here is what he had to say in response to our query:
Such was the case recently with the California's chiropractic board, which is enshrined in the State Constitution. Gov. Arnold Schwarzenegger's appointees to the board became carried away in what a deputy attorney general described as a fit of "lawlessness." Now the board faces a serious legislative investigation that could include elimination of its $3 million budget.
While this is something of a minor tempest – although not for chiropractors -- the chiropractic board shares several things in common with California's much heftier, $3 billion stem cell agency. Both are written into the State Constitution. Both were created by initiative. Both have issues involving conflicts of interest. And both function in near obscurity except when they hand out buckets of money – in the case of the stem cell agency – or when a scandal erupts, as in the case of chiropractic board.
Obviously major differences exist between the two boards, including the quality of the appointees. But the case of the chiropractors illustrates how quickly matters can go awry in an insular agency and how quickly the legislature may move to step in. The case will also probably show how quickly the governor can put distance between himself and what The Sacramento Bee called a "laughingstock."
Last Sunday we discussed the sometimes acrimonious relationship between CIRM and the California legislature, particularly in the light of bipartisan legislation by the chair of the Senate Health Committee, Sen. Sheila Kuehl, D-Santa Monica. Her measure would inject the legislature into the difficult and touchy matter of how the stem cell agency decides to share the potentially enormous wealth from cures developed with state-funded research. After a shaky start with lawmakers, CIRM has moved to improve its legislative relations and keep lawmakers well informed.
Our piece, which appeared as an op-ed in The Sacramento Bee, was necessarily limited because of space. But we wanted to share more that we heard from CIRM and two longtime observers of the agency, who also have been critical of its performance from time to time and sometimes even more often. What follows are virtually verbatim comments.
First, from Dale Carlson, chief communications officer for the stem cell agency:
"We have an active government affairs program underway in Sacramento focused on legislators and statewide office holders, as well as their respective staff members. We want to keep them apprised of our efforts and progress, the status of key regulatory and funding initiatives, and the challenges we are confronting in pursuit of our mandate and obligations.Carlson also said that Klein, Penhoet, Kleinschmidt and Patricia Olson, who led development of the CIRM strategic plan, had a 90-minute meeting with Kuehl last Wednesday.
"The objective is to ensure that key decision-makers have current, accurate, and reliable information about CIRM's activities, the field of stem cell research, and related issues. We seem to receive reports of new scientific developments every week, and with more states committing funding to the field each year, it's likely that pace will accelerate. It's a challenge for us to stay abreast of the science, federal policy, and other states' emerging policies, all of which have an effect on our scientific project.
"We're very proud of the work we're doing, the processes we follow to engage the public in the development of policies and regulations that are required by the law, and the willingness we've demonstrated to adopt and apply good ideas from variety of sources. We want to be recognized as a credible source of information on all things stem cell, regardless of whether the question is directly related to CIRM's activities.
"Our legislative affairs program includes one-on-one meetings and group briefings. (Early in February), for example, ICOC Vice Chair Ed Penhoet and several CIRM staff held a session with staff from the Speaker's office and the Senate Health Committee and others, to review our IP policies for non-profits and for-profits. Both have been the subject of great interest and discussion in Sacramento (as well as throughout the state and in Washington, D.C.), with legislators offering many suggestions for how those policies might be crafted and strengthened. Our presentation described the progress we've made to date - emphasizing that the regulatory process is still moving forward and unlikely to be completed for several months - as well as a review of the issues we're struggling to address. "(Later in February), (CIRM President) Zach Hall, Arlene Chiu, and Mary Maxon (Chiu and Maxon are CIRM staff) conducted a broader briefing on the basics of stem cells, the progress we've made in our first two years, including on the IP policies, and the grants approved by the ICOC.
"Kirk Kleinschmidt, our Director of Legislation and Research Policy, has day-to-day responsibility for the effort. In addition to arranging these group sessions, he's regularly in the capital meeting with individual members. Gene Erbin from Nielsen Merksamer is on retainer to support the effort. Per the provisions of Proposition 71, (Stem Cell Chairman) Bob Klein oversees the legislative affairs program in consultation with the Legislative Subcommittee and the ICOC. He's in regular contact with federal and the statewide office holders as well as the legislative
leadership."
Carlson said it was a "detailed discussion of our IP policies, the drug/therapy development process and the extensive public process we've followed."
"This is the kind of relationship we want with the legislature. Respectful and substantive. We want them to be assured that we're going about our responsiblities thoughtfully and carefully, and that we welcome good ideas and the opportunity to discuss our efforts."Carlson said the CIRM board will meet in Sacramento April 10 and expects to finish its meeting in time for board members to visit with legislators in the afternoon.
Jesse Reynolds, project director on biotechnology accountability for the Center for Genetics and Society in Oakland, has followed CIRM closely during the last two years as well as the Prop. 71 campaign.
Here is what he had to say in response to our query:
"Prop. 71 is a deeply flawed set of laws, with numerous exemptions to the norms of transparency, oversight and accountability....John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights in Santa Monica, Ca., is another longtime follower of CIRM matters. He said,
"Hopefully, the leadership of the CIRM won't be as hostile to much-needed reform as it was during previous attempts. Then, the state's 'stem cell czar,' Robert Klein took the unprecedented step of hiring a lobbyist with taxpayer funds. What's more, while serving as chair of the CIRM's governing board, he simultaneously headed up a private lobbying organization, which advocates for more funding and less oversight of stem cell research. These actions are not appropriate for the head of a state agency.
"Klein's statements that 'the Legislature is not needed' and that then-Senator Ortiz was 'an ongoing threat' are not only wrong, but highlight his cavalier attitude in his role as a public servant. As the people's elected representatives, the Legislature certainly has a critical role in overseeing a multi-billion dollar program. As a senator, Ortiz did more for stem cell research and Proposition 71 than any other elected official."
"Key to any IP policy are provisions that ensure affordable access for all Californians to any cures or treatments resulting from stem cell research they funded. The ICOC originally envisioned meeting that goal by requiring treatments purchased with public funds to be sold at the federal Medicaid price and that there be a plan in place that would provide access to the treatments for uninsured people.
"In drawing up the actual regulatory language to implement those policies, the ICOC has softened those proposals.....
"I think Kuehl's bill would increase payback to the state, but doesn't do enough to ensure affordable access for all Californians. There should be a provision that if there are unreasonable prices the attorney general can intervene. I cite Genentech's Avastin as an example of what cannot be allowed. The drug was developed with $44.6 million in public funds from the National Cancer Institute yet Genentech charges $100,000 a year for it.
"I'd also like to see action on governance and accountability issues. I don't know what Sen. Kuehl's plans are in this regard. Members of the various working groups should be required to file public disclosures of their interests. All applicants and their institutions should be identified, not just recipients. Finally the ICOC is too large. It should be trimmed from the 29 members who now have seats.
"Another thought: ICOC members themselves have expressed concerns about some provisions of Prop 71. It might be useful for both CIRM and the legislature to attempt to identify such areas and agree on making those changes."
Tuesday, March 13, 2007
CIRM Lending Plan Resurfaces, State Pension Funds Eyed
California stem cell Chairman Robert Klein Tuesday said $3 billion for stem cell research is not enough and touted a loan plan to leverage the state's investment.
Klein proposed lending a portion of CIRM's funds, which, when they were paid back with interest, could either be loaned once more or used as grants. He also suggested that the mammoth California state employee and teachers pension funds could be tapped for additional investments in stem cell companies and research.
Declaring that CIRM's goal is to develop cures, Klein said, "Three billion dollars is not going to get us there."
Some time ago, a CIRM committee briefly addressed the issue of making loans but put off any additional discussion to deal with more pressing matters.
Klein addressed the loan issue in the context of providing financial assistance for clinical trials, which can be very expensive. He said loans allow money to be "recycled" and increased through collection of interest. He suggested that they would be issued in the form of subordinated debentures to make them more palatable to the businesses involved.
Klein appeared at the Burrill & Company stem cell conference on a panel discussion that was entitled "The CIRM Strategic Plan: Corporate Perspectives."
The panel was chaired by David Gollaher, president of the biomedical industry group, the California Healthcare Institute. The group has expressed displeasure with CIRM's efforts concerning intellectual property, declaring that they threaten commercialization of stem cell therapies.
Gollaher did not specifically cite the CIRM rules or related legislation (SB771 by Sen. Sheila Kuehl, D-Santa Monica) but he warned against placing barriers to development of products. Klein said it was important to provide economic incentives. He said that "preferential pricing has to be modulated and balanced against the primary mission" of the agency, which is to develop cures.
Bruce Cohen, president of Cellerant Technologies, said CIRM's royalty rules are "painful but we can live them." He described them as "measurable and capped." But he said rules dealing with pricing make businesses "very, very frightened." He said they could have a "chilling effect" on a decision whether to take CIRM funds. Cohen noted that many medical firms already have plans to provide access to their products by low income persons.
Klein proposed lending a portion of CIRM's funds, which, when they were paid back with interest, could either be loaned once more or used as grants. He also suggested that the mammoth California state employee and teachers pension funds could be tapped for additional investments in stem cell companies and research.
Declaring that CIRM's goal is to develop cures, Klein said, "Three billion dollars is not going to get us there."
Some time ago, a CIRM committee briefly addressed the issue of making loans but put off any additional discussion to deal with more pressing matters.
Klein addressed the loan issue in the context of providing financial assistance for clinical trials, which can be very expensive. He said loans allow money to be "recycled" and increased through collection of interest. He suggested that they would be issued in the form of subordinated debentures to make them more palatable to the businesses involved.
Klein appeared at the Burrill & Company stem cell conference on a panel discussion that was entitled "The CIRM Strategic Plan: Corporate Perspectives."
The panel was chaired by David Gollaher, president of the biomedical industry group, the California Healthcare Institute. The group has expressed displeasure with CIRM's efforts concerning intellectual property, declaring that they threaten commercialization of stem cell therapies.
Gollaher did not specifically cite the CIRM rules or related legislation (SB771 by Sen. Sheila Kuehl, D-Santa Monica) but he warned against placing barriers to development of products. Klein said it was important to provide economic incentives. He said that "preferential pricing has to be modulated and balanced against the primary mission" of the agency, which is to develop cures.
Bruce Cohen, president of Cellerant Technologies, said CIRM's royalty rules are "painful but we can live them." He described them as "measurable and capped." But he said rules dealing with pricing make businesses "very, very frightened." He said they could have a "chilling effect" on a decision whether to take CIRM funds. Cohen noted that many medical firms already have plans to provide access to their products by low income persons.
Uniform ESC Research Standards, More Federal Funding? Lower Your Expectations
The "bizarre patchwork" of embryonic stem cell regulation across the country is not going to disappear regardless of what happens in the presidential election in 2008, several speakers said today at a stem cell conference in San Francisco.
It was not a message that the audience of 500 persons from throughout the world necessarily wanted to hear. Their preference would be for unified standards with ample predictability, ideally at the federal if not global level.
But Nancy Forbes, an attorney with Ropes & Gray of Boston and San Francisco, said "The genie is not going to go back in the bottle." She said she has never seen a governmental body roll back its jurisdiction.
It was a theme echoed by others on the panel discussing "The Un-United States: Cell Lines Border Lines and The Law" at The Stem Cell Meeting, sponsored by Burrill & Company.
Ken Taymor, an attorney with MBV Law of San Francisco and who has followed California stem cell issues closely, also noted that there is little likelihood of a flood of federal ESC research funding following the 2008 election.
He said the NIH, in fact, may look at all the state and private research efforts underway and decide that it does not need to spend its limited funds in the area, an ironic negative effect of state activity aimed at beefing up stem cell research funding.
Russell Korobkin, a UCLA law professor, tackled what he called the "most problematic" aspect of the the stem cell laws across the nation – the bar against compensating women who donate their eggs. He said that compensation is permitted for donation of eggs for in vitro fertilization, which is identical to the process for donating eggs for research.
Korobkin dissected the argument for the compensation ban. He said it does not prevent coercion of women; rather it is actually coercive by limiting what women may do. The argument also assumes that "women cannot make the best decision" concerning egg donation and need to be protected by the state. If the process is too risky, he said, it should be banned regardless of payment or lack of payment. And it is not clear that the ban protects society as a whole, Korobkin argued.
Underlying the argument for compensation prohibitions seems to be "a wish that there were no women so poor that they would be motivated by their eggs," the law professor said.
Korobkin, however, did not deal with the politically touchy nature of repealing the ban on compensation. The subject is freighted with emotions that are fueled by the nightmarish visions of some of egg factories in poverty-stricken corners of the country or the world. Few lawmakers are inclined to support the repeal of compensation lest they get tarred with a brush from that very same vision.
It was not a message that the audience of 500 persons from throughout the world necessarily wanted to hear. Their preference would be for unified standards with ample predictability, ideally at the federal if not global level.
But Nancy Forbes, an attorney with Ropes & Gray of Boston and San Francisco, said "The genie is not going to go back in the bottle." She said she has never seen a governmental body roll back its jurisdiction.
It was a theme echoed by others on the panel discussing "The Un-United States: Cell Lines Border Lines and The Law" at The Stem Cell Meeting, sponsored by Burrill & Company.
Ken Taymor, an attorney with MBV Law of San Francisco and who has followed California stem cell issues closely, also noted that there is little likelihood of a flood of federal ESC research funding following the 2008 election.
He said the NIH, in fact, may look at all the state and private research efforts underway and decide that it does not need to spend its limited funds in the area, an ironic negative effect of state activity aimed at beefing up stem cell research funding.
Russell Korobkin, a UCLA law professor, tackled what he called the "most problematic" aspect of the the stem cell laws across the nation – the bar against compensating women who donate their eggs. He said that compensation is permitted for donation of eggs for in vitro fertilization, which is identical to the process for donating eggs for research.
Korobkin dissected the argument for the compensation ban. He said it does not prevent coercion of women; rather it is actually coercive by limiting what women may do. The argument also assumes that "women cannot make the best decision" concerning egg donation and need to be protected by the state. If the process is too risky, he said, it should be banned regardless of payment or lack of payment. And it is not clear that the ban protects society as a whole, Korobkin argued.
Underlying the argument for compensation prohibitions seems to be "a wish that there were no women so poor that they would be motivated by their eggs," the law professor said.
Korobkin, however, did not deal with the politically touchy nature of repealing the ban on compensation. The subject is freighted with emotions that are fueled by the nightmarish visions of some of egg factories in poverty-stricken corners of the country or the world. Few lawmakers are inclined to support the repeal of compensation lest they get tarred with a brush from that very same vision.
Monday, March 12, 2007
Not Coming Up
Earlier I advised that more would be coming today on relations involving CIRM and the California legislature. However, other matters have intervened. Look for the stuff on Wednesday.
Do Stem Cells, Go to Jail
A Stanford law professor Monday told a group of stem cell scientists and businessmen and women in California that some of them would be subject to hard time in prison if they were sitting in South Dakota.
Henry Greely used the example to illustrate the "bizarre patchwork" of stem cell regulation in the United States, which varies widely from state to state. Greely said that some of the stem cell activities that some members of his audience are engaged in would be illegal in South Dakota.
Greely, who heads a California advisory panel on stem cell regulations, pointed out that regulations and patent law vary widely also from country to country, posing possibilities for confusion and "offshore production" of stem cell products.
Speaking to The Stem Cell Meeting in San Francisco sponsored by Burrill & Company, Greely indicated that a Stanford researcher collaborating with a British scientist could possibly be breaching Stanford research rules -- if the British scientist did not have the same set of research standards. Failure to abide by Stanford's rules could result in professional discipline at the university.
Hope for standardized regulations is dim in the short term, he indicated. Even if a new president in 2009 liberalizes federal stem cell research rules, variations will continue to exist from state to state unless Congress passes a strong new law regulating the science.
Greely said the best hope for something like universal acceptance of embryonic stem cell research would be a well-publicized cure. Then, he said, "political and moral objections will evaporate like the morning mist."
Meanwhile, Greely advised his audience to consult their attorneys, pay careful attention to details and pool information about stem cell research.
Henry Greely used the example to illustrate the "bizarre patchwork" of stem cell regulation in the United States, which varies widely from state to state. Greely said that some of the stem cell activities that some members of his audience are engaged in would be illegal in South Dakota.
Greely, who heads a California advisory panel on stem cell regulations, pointed out that regulations and patent law vary widely also from country to country, posing possibilities for confusion and "offshore production" of stem cell products.
Speaking to The Stem Cell Meeting in San Francisco sponsored by Burrill & Company, Greely indicated that a Stanford researcher collaborating with a British scientist could possibly be breaching Stanford research rules -- if the British scientist did not have the same set of research standards. Failure to abide by Stanford's rules could result in professional discipline at the university.
Hope for standardized regulations is dim in the short term, he indicated. Even if a new president in 2009 liberalizes federal stem cell research rules, variations will continue to exist from state to state unless Congress passes a strong new law regulating the science.
Greely said the best hope for something like universal acceptance of embryonic stem cell research would be a well-publicized cure. Then, he said, "political and moral objections will evaporate like the morning mist."
Meanwhile, Greely advised his audience to consult their attorneys, pay careful attention to details and pool information about stem cell research.
The Multibillion Dollar Stem Cell Market and Its Challenges
Today's market for stem cell therapies in the United States currently runs around $100 million but is expected shoot up to $710 million in three years, venture capitalist Steve Burrill said Monday.
By 2016, the market could hit $8.5 billion, he told about 500 persons attending The Stem Cell Meeting at the UC San Francisco Mission Bay complex.
The event, sponsored by Burrill & Company and which drew attendees from throughout the world, focused on both the science and business of stem cells.
Access to capital for fledgling stem firms was the topic of one panel Monday morning. Speakers from stem cell company indicated that funds are still tight, but that some loosening seemed to be occurring that was related to the more favorable political climate in Washington, D.C.
Burrill said a "reasonable amount of money" is available around the world, but different investors have different appetites, depending on the perspective from their countries.
He asked a panel of stem cell business executives about the biggest challenges for the stem cell business. One replied that predictable manufacturing processes were needed. Another said bigger companies with larger resources were necessary. William Caldwell, head of Advanced Cell Technology of Alameda, Ca., said the key was "curing the first patient."
Zach Hall, president of the California stem cell agency, echoed Caldwell during his overview of the status of the state's $3 billion research effort. To do that, Hall said CIRM expected ultimately to partner with the private sector.
Hall said the agency will have awarded about $190 million in grants to nonprofit agencies by sometime this summer with research being financed in about 100 labs throughout the state. Hall said CIRM hopes to build a "very strong pipeline" for research. That's because of the high disappointment rate involved in research. Hall noted that only one out of every eight to 10 clinical trials results in a viable product. And those trials occur at an advanced stage in the development of a therapy or cure.
We will have continuing coverage of the Burrill stem cell conference today and Tuesday.
By 2016, the market could hit $8.5 billion, he told about 500 persons attending The Stem Cell Meeting at the UC San Francisco Mission Bay complex.
The event, sponsored by Burrill & Company and which drew attendees from throughout the world, focused on both the science and business of stem cells.
Access to capital for fledgling stem firms was the topic of one panel Monday morning. Speakers from stem cell company indicated that funds are still tight, but that some loosening seemed to be occurring that was related to the more favorable political climate in Washington, D.C.
Burrill said a "reasonable amount of money" is available around the world, but different investors have different appetites, depending on the perspective from their countries.
He asked a panel of stem cell business executives about the biggest challenges for the stem cell business. One replied that predictable manufacturing processes were needed. Another said bigger companies with larger resources were necessary. William Caldwell, head of Advanced Cell Technology of Alameda, Ca., said the key was "curing the first patient."
Zach Hall, president of the California stem cell agency, echoed Caldwell during his overview of the status of the state's $3 billion research effort. To do that, Hall said CIRM expected ultimately to partner with the private sector.
Hall said the agency will have awarded about $190 million in grants to nonprofit agencies by sometime this summer with research being financed in about 100 labs throughout the state. Hall said CIRM hopes to build a "very strong pipeline" for research. That's because of the high disappointment rate involved in research. Hall noted that only one out of every eight to 10 clinical trials results in a viable product. And those trials occur at an advanced stage in the development of a therapy or cure.
We will have continuing coverage of the Burrill stem cell conference today and Tuesday.
Sunday, March 11, 2007
Two Days of Stem Cells: Founder Flight to Hyperventilation
Christopher Thomas Scott, executive director of Stanford's Program on Stem Cells in Society, is scheduled to set the scene Monday for a two-day international conference on stem cells in San Francisco.
"The business issues are profound," he says, "including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against 'founder flight' as entrepreneurs seek permissive jurisdictions to launch their businesses."
We asked Scott, who is co-chair of the conference sponsored by Burrill & Company, for a preview of his remarks. Here is what he supplied.
"No one can deny the promise of regenerative medicine. But the field has its shaky spots: an astonishingly young science, polarized politics, and fraught with ethical worry. Yet stem cell biology has been on a tear lately. In just a handful of years, the science has moved from hunting stem cells to the arcane secrets of signal transduction. The hyperventilation about which stem cells--embryonic or adult--will be clinically useful is largely lost on scientists. The questions facing them are more elemental: can stem cells be chemically reprogrammed to earlier, more powerful versions of themselves? On which branch of the family tree does a new stem cell rest? What gene signals cause a stem cell to make more stem cells, or change into the next cell type down the line? The last question is on every researcher’s mind, because signal pathways are critical to understand how a certain type of cell can be made from an embryonic stem cell line, or how millions of adult stem cells can be made from a just a few to treat disease.
"2006 was a watershed year in other ways. Most Americans support embryonic stem cell research, and so does Congress. Despite a vote in the House and Senate that would overturn a restrictive presidential mandate, it wasn't enough to override George Bush's first-ever veto. California pushed through a thicket of lawsuits to shake loose billions of dollars for regenerative medicine. Now, finally, there is light at the end of that tunnel. Legislation in other states is moving so quickly it's difficult to keep track: just last week, Illinois, Iowa, Minnesota signed laws to permit all types of stem cell research. As political winds fanned the flames stateside, stem cells went international, creating a different kind of global warming. In a mighty push, Australia overturned a ban on nuclear transfer. The world's researchers had a banner year, with Japan, Germany, Norway and others announcing major discoveries. Not all the offshore news was good, however. The heat created a conflagration with the biggest scientific fraud in memory, the South Korean scandal.
"One thing is certain--international politics and the legal landscape has altered the way we do biomedical research. Thomas Friedman's "global flattening" doesn't apply here. A mosaic of legislation and national policy means uneven terrain for funding, infrastructure and accessibility to embryos and lines. The business issues are profound, including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against "founder flight" as entrepreneurs seek permissive jurisdictions to launch their businesses. The vacuum in Washington has shattered the state legislative landscape. In one state, a scientist can go to jail for doing embryonic stem cell research. In another, embryos can't be used for research, but it is fine to ship them in across the border. And who would have predicted this in 2001, the year of Bush's pronouncement: once funding from California, Wisconsin, New Jersey, Connecticut, Illinois, Maryland, Massachusetts, and other states is fully unleashed, it will surpass by a wide margin any dedicated federal dollars, restricted or otherwise.
"With all the moving parts, it made sense to assemble a group of experts and scholars from many disciplines to address issues at the interface of science, business, economics, law, and policy. I was delighted when Burrill & Company asked me to develop an agenda that would explore these connections. As a rule, stem cell conferences tend to be monolithic, in part because the reach of regenerative medicine is too broad to be addressed in two or three days. But to my knowledge, no conference tackles these questions from an international perspective. I'm excited to learn what this stellar group has to say, and how the glimmering edge of biology's most promising frontier will look in 2007 and beyond."
We will attending the conference both days. Watch for continuing coverage of the event.
"The business issues are profound," he says, "including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against 'founder flight' as entrepreneurs seek permissive jurisdictions to launch their businesses."
We asked Scott, who is co-chair of the conference sponsored by Burrill & Company, for a preview of his remarks. Here is what he supplied.
"No one can deny the promise of regenerative medicine. But the field has its shaky spots: an astonishingly young science, polarized politics, and fraught with ethical worry. Yet stem cell biology has been on a tear lately. In just a handful of years, the science has moved from hunting stem cells to the arcane secrets of signal transduction. The hyperventilation about which stem cells--embryonic or adult--will be clinically useful is largely lost on scientists. The questions facing them are more elemental: can stem cells be chemically reprogrammed to earlier, more powerful versions of themselves? On which branch of the family tree does a new stem cell rest? What gene signals cause a stem cell to make more stem cells, or change into the next cell type down the line? The last question is on every researcher’s mind, because signal pathways are critical to understand how a certain type of cell can be made from an embryonic stem cell line, or how millions of adult stem cells can be made from a just a few to treat disease.
"2006 was a watershed year in other ways. Most Americans support embryonic stem cell research, and so does Congress. Despite a vote in the House and Senate that would overturn a restrictive presidential mandate, it wasn't enough to override George Bush's first-ever veto. California pushed through a thicket of lawsuits to shake loose billions of dollars for regenerative medicine. Now, finally, there is light at the end of that tunnel. Legislation in other states is moving so quickly it's difficult to keep track: just last week, Illinois, Iowa, Minnesota signed laws to permit all types of stem cell research. As political winds fanned the flames stateside, stem cells went international, creating a different kind of global warming. In a mighty push, Australia overturned a ban on nuclear transfer. The world's researchers had a banner year, with Japan, Germany, Norway and others announcing major discoveries. Not all the offshore news was good, however. The heat created a conflagration with the biggest scientific fraud in memory, the South Korean scandal.
"One thing is certain--international politics and the legal landscape has altered the way we do biomedical research. Thomas Friedman's "global flattening" doesn't apply here. A mosaic of legislation and national policy means uneven terrain for funding, infrastructure and accessibility to embryos and lines. The business issues are profound, including access to patients, fragmented intellectual property and a new calculus of investment risk that includes whether the research is illegal and how to mitigate against "founder flight" as entrepreneurs seek permissive jurisdictions to launch their businesses. The vacuum in Washington has shattered the state legislative landscape. In one state, a scientist can go to jail for doing embryonic stem cell research. In another, embryos can't be used for research, but it is fine to ship them in across the border. And who would have predicted this in 2001, the year of Bush's pronouncement: once funding from California, Wisconsin, New Jersey, Connecticut, Illinois, Maryland, Massachusetts, and other states is fully unleashed, it will surpass by a wide margin any dedicated federal dollars, restricted or otherwise.
"With all the moving parts, it made sense to assemble a group of experts and scholars from many disciplines to address issues at the interface of science, business, economics, law, and policy. I was delighted when Burrill & Company asked me to develop an agenda that would explore these connections. As a rule, stem cell conferences tend to be monolithic, in part because the reach of regenerative medicine is too broad to be addressed in two or three days. But to my knowledge, no conference tackles these questions from an international perspective. I'm excited to learn what this stellar group has to say, and how the glimmering edge of biology's most promising frontier will look in 2007 and beyond."
We will attending the conference both days. Watch for continuing coverage of the event.
Klein on Clinical Trial Problems with ESC Research
California stem cell Chairman Robert Klein is concerned about "tragedies" during clinical trials of cures developed with funding by the state of California.
He made the comment in a question-and-answer interview with reporter Steve Johnson of the San Jose Mercury News.
Klein was asked about his main concerning clinical trials funded by CIRM.
He replied:
He made the comment in a question-and-answer interview with reporter Steve Johnson of the San Jose Mercury News.
Klein was asked about his main concerning clinical trials funded by CIRM.
He replied:
"We need to work with the patient advocacy groups and the public so they understand that as we start trials there will be great victories, there also will be tragedies. They need to understand this is part of the process we need to go through. Because if the public is not broadly informed, there could be a reaction that could shut down the trial."However, any clinical trials are years away. CIRM also may not be involved in their direct funding, although the cures may be based on state-funded research.
CIRM IP Legislation Faces Tall Hurdle
The following – written by yours truly -- appeared today in The Sacramento Bee as an op-ed piece. We will bring you more details of CIRM's current legislative efforts on Monday.
-------
Nearly three years ago, California voters created a unique and nearly autonomous agency that set the state on a $3 billion foray into embryonic stem cell research. Under the terms of Proposition 71, voters told the new California Institute for Regenerative Medicine to hand out $300 million annually in hopes that the grants would lead to cures for everything from diabetes to cancer.
Voters also told legislators not to mess with the institute at least for three years. Now that time is nearly up. And two powerful legislators are mounting the first effort -- under the terms of Proposition 71 -- to intervene in the institute's affairs.
The stakes are enormous and involve potentially billions of dollars of profits from stem cell therapies and cures.
The legislation was introduced last month by the chair of the Senate Health Committee, Sheila Kuehl, D-Santa Monica, and the Republican caucus leader in the Senate, George Runner of Antelope Valley. Their Senate Bill 771 is aimed at ensuring that California receives a healthy return on its investment and that state-funded cures are affordable and accessible.
But the senators face an extraordinary obstacle. Under Proposition 71, their legislation requires not just a majority vote to pass -- not just a supermajority vote (two-thirds) -- but a super, supermajority vote of 70 percent. That means 13 senators can kill the bill.
California's biotech industry and the institute are probably already compiling a list of their 13 best friends in the Senate. The state's leading biomedical organization, the California Healthcare Institute, is unhappy with the stem cell institute's intellectual property rules for sharing the wealth, declaring that they provide "a substantial disincentive" for creating commercial cures.
The rules determine who owns the results of the state-funded research, in other words, the intellectual property. They also determine how the intellectual property may be used and who, including the state, will receive royalties and under what conditions.
The California Healthcare Institute has not taken a position on Kuehl's bill but has indicated that it does not want to be hamstrung.
Runner and Kuehl, however, have an unlikely source of support. That's the legacy of the less-than-adroit legislative maneuvers by California stem cell Chairman Robert Klein. Much as President Bush's decision to limit funding for stem cell research spawned Proposition 71, Klein's actions ironically have fostered an environment conducive to the Kuehl bill's success.
Klein not only irritated some lawmakers, but some members of the stem cell institute's Oversight Committee as well. They were not pleased by his broadsides, such as denouncing the former chair of the Senate Health Committee, Deborah Ortiz, D-Sacramento, as an "ongoing threat." That message was delivered last year in a widely disseminated e-mail to patient groups via Klein's nonprofit advocacy group, Americans for Stem Cell Therapies and Cures.
The stem cell institute has attempted to strengthen its legislative ties. It took the unusual step, for a state agency, of hiring a private lobbyist, the well-connected Nielsen, Merksamer, Parrinello, Mueller & Naylor for $4,100 a month. More recently, the institute reached out to lawmakers and legislative staff, sending delegations to Sacramento twice last month, including Zach Hall, the institute's president, and Ed Penhoet, vice chair of the Oversight Committee and head of its intellectual property task force.
Kuehl has a tall hurdle to clear -- the 70 percent vote, not to mention the governor. She is stepping into a complex arena -- intellectual property -- where little unanimity exists, as the institute has discovered. But even if the bill fails, it will help to provide broader input on policies about intellectual property, developed during sparsely attended hearings. The measure additionally will serve as an important test of the institute's openness and political savvy.
While the agency is uniquely independent, California lawmakers are capable of creating much mischief when they feel their constituencies have been slighted. And that is mischief that the institute should avoid, so it can focus on its primary mission, as the institute proclaims, "turning stem cells into cures."
-------
Nearly three years ago, California voters created a unique and nearly autonomous agency that set the state on a $3 billion foray into embryonic stem cell research. Under the terms of Proposition 71, voters told the new California Institute for Regenerative Medicine to hand out $300 million annually in hopes that the grants would lead to cures for everything from diabetes to cancer.
Voters also told legislators not to mess with the institute at least for three years. Now that time is nearly up. And two powerful legislators are mounting the first effort -- under the terms of Proposition 71 -- to intervene in the institute's affairs.
The stakes are enormous and involve potentially billions of dollars of profits from stem cell therapies and cures.
The legislation was introduced last month by the chair of the Senate Health Committee, Sheila Kuehl, D-Santa Monica, and the Republican caucus leader in the Senate, George Runner of Antelope Valley. Their Senate Bill 771 is aimed at ensuring that California receives a healthy return on its investment and that state-funded cures are affordable and accessible.
But the senators face an extraordinary obstacle. Under Proposition 71, their legislation requires not just a majority vote to pass -- not just a supermajority vote (two-thirds) -- but a super, supermajority vote of 70 percent. That means 13 senators can kill the bill.
California's biotech industry and the institute are probably already compiling a list of their 13 best friends in the Senate. The state's leading biomedical organization, the California Healthcare Institute, is unhappy with the stem cell institute's intellectual property rules for sharing the wealth, declaring that they provide "a substantial disincentive" for creating commercial cures.
The rules determine who owns the results of the state-funded research, in other words, the intellectual property. They also determine how the intellectual property may be used and who, including the state, will receive royalties and under what conditions.
The California Healthcare Institute has not taken a position on Kuehl's bill but has indicated that it does not want to be hamstrung.
Runner and Kuehl, however, have an unlikely source of support. That's the legacy of the less-than-adroit legislative maneuvers by California stem cell Chairman Robert Klein. Much as President Bush's decision to limit funding for stem cell research spawned Proposition 71, Klein's actions ironically have fostered an environment conducive to the Kuehl bill's success.
Klein not only irritated some lawmakers, but some members of the stem cell institute's Oversight Committee as well. They were not pleased by his broadsides, such as denouncing the former chair of the Senate Health Committee, Deborah Ortiz, D-Sacramento, as an "ongoing threat." That message was delivered last year in a widely disseminated e-mail to patient groups via Klein's nonprofit advocacy group, Americans for Stem Cell Therapies and Cures.
The stem cell institute has attempted to strengthen its legislative ties. It took the unusual step, for a state agency, of hiring a private lobbyist, the well-connected Nielsen, Merksamer, Parrinello, Mueller & Naylor for $4,100 a month. More recently, the institute reached out to lawmakers and legislative staff, sending delegations to Sacramento twice last month, including Zach Hall, the institute's president, and Ed Penhoet, vice chair of the Oversight Committee and head of its intellectual property task force.
Kuehl has a tall hurdle to clear -- the 70 percent vote, not to mention the governor. She is stepping into a complex arena -- intellectual property -- where little unanimity exists, as the institute has discovered. But even if the bill fails, it will help to provide broader input on policies about intellectual property, developed during sparsely attended hearings. The measure additionally will serve as an important test of the institute's openness and political savvy.
While the agency is uniquely independent, California lawmakers are capable of creating much mischief when they feel their constituencies have been slighted. And that is mischief that the institute should avoid, so it can focus on its primary mission, as the institute proclaims, "turning stem cells into cures."
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