The CIRM Standards Working Group had a plateful last week, dealing with the question of whether it can finance human embryonic stem cell research involving cell lines that were derived prior to CIRM regulations.
The short answer is provided by John M. Simpson, stem cell project director of the Consumer Watchdog group, who attended the meeting. He wrote on his group's blog:
"A stem cell line may be deemed acceptably derived before November 2006 if the following criteria are met:
"Informed consent from woman or couple in IVF (and no indication that original donor would not consent for research).
"Approval of the donation protocol by an Institutional Review Board.
"Compliance with prevailing ethical and legal standards in place at the time of derivation in the jurisdiction where the derivation was carried out.
"The process to determine if the criteria had been met would begin with a request to CIRM. The staff would review the request and make a recommendation to the oversight board, the Independent Citizens Oversight Committee. The review would have to include consideration of the scientific significance of the stem cell line. The ICOC would consider the request in a public meeting after publicly posting it."
The Standards Working Group did not have a quorum so its "plan" will go to directors, presumably at their August meeting, as representing the "sense of the group" but without a formal recommendation. Such a practice is commonplace with CIRM since it has perennial problems with securing quorums at meetings.
If you see problems with the CIRM proposal or support it, now is the time to send something along to the agency.
Tuesday, July 29, 2008
Klein Confirms Resignation, Lobbying Connections Remain
The chairman of the California stem cell agency has personally confirmed that he has resigned as head of his personal stem cell lobbying group, Americans for Cures, which has been nearly silent on the subject since July 14.
Robert Klein's exit as president of the group came after it excoriated an influential California lawmaker on a widely read political blog, the Daily Kos.
Second-hand reports surfaced (the first on July 14) that he was resigning as president of the group, which shares the same address as his real estate investment firm as well as the same fax number.
Since then, Americans for Cures has not responded to repeated requests asking for confirmation of Klein's departure. Nor did Klein tell state Sen. Sheila Kuehl, object of the attack, that he was resigning, as he had said he would.
But Robert M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., encountered Klein last week at the meeting of the CIRM Standards Working Group. Simpson said,
On July 24, we wrote about Klein's failure to announce his resignation, commenting that the initial, second-hand reports may have amounted to some sort of trial balloon that Klein hoped would trigger calls for him to remain as head of Americans for Cures.
Don Gibbons, chief communications officer for CIRM, today volunteered the following reaction to our trial balloon comment,
Klein's resignation, however, is less than a half-measure and does not even well serve his own best interests. If it is an attempt to distance himself from the organization, it falls far short. If he continues to serve on the board of directors of the lobbying group, if the group continues to share Klein's office fax number and address, if he continues to control hiring and policy and generate financing for the group, Klein remains accountable for whatever the group does. Particularly for any actions that do not coincide with the best interests of the people of California or CIRM.
Klein volunteered for his role at CIRM and has not been paid for his work for nearly three years, which is all to his credit. Would that more California businessmen and women donate their time and energy to help solve some of society's difficult problems.
But when Klein accepted his job as a public servant, other activities became incompatible. One of those is directing a lobbying group that operates in the same area as CIRM.
As we reported earlier, Klein's dual roles represent an inherent conflict of interest. It is as if a high level executive with the California Medical Association also served on the state Medical Board. It is impossible to know whether their official actions represent their own views or the views of the special interest group.
Robert Klein's exit as president of the group came after it excoriated an influential California lawmaker on a widely read political blog, the Daily Kos.
Second-hand reports surfaced (the first on July 14) that he was resigning as president of the group, which shares the same address as his real estate investment firm as well as the same fax number.
Since then, Americans for Cures has not responded to repeated requests asking for confirmation of Klein's departure. Nor did Klein tell state Sen. Sheila Kuehl, object of the attack, that he was resigning, as he had said he would.
But Robert M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., encountered Klein last week at the meeting of the CIRM Standards Working Group. Simpson said,
"I asked Klein what his status with the group was when I saw him on Friday. He said that he had resigned the night he learned about the Kos article and came back from vacation.Since then, the reference to Klein as president has been removed from the website by Americans for Cures, along with a list of all its directors.
"I told him that his name was still on the website. He said he'd call them to have it removed."
On July 24, we wrote about Klein's failure to announce his resignation, commenting that the initial, second-hand reports may have amounted to some sort of trial balloon that Klein hoped would trigger calls for him to remain as head of Americans for Cures.
Don Gibbons, chief communications officer for CIRM, today volunteered the following reaction to our trial balloon comment,
"The Americans for Cures web site has been corrected regarding the president. That theory you put forth on the issue goes beyond speculative paranoia."With his resignation, Klein has recognized that his connections with Americans for Cures are not compatible with his role as a public servant and chairman of an agency that is giving away $3 billion of California taxpayer's money.
Klein's resignation, however, is less than a half-measure and does not even well serve his own best interests. If it is an attempt to distance himself from the organization, it falls far short. If he continues to serve on the board of directors of the lobbying group, if the group continues to share Klein's office fax number and address, if he continues to control hiring and policy and generate financing for the group, Klein remains accountable for whatever the group does. Particularly for any actions that do not coincide with the best interests of the people of California or CIRM.
Klein volunteered for his role at CIRM and has not been paid for his work for nearly three years, which is all to his credit. Would that more California businessmen and women donate their time and energy to help solve some of society's difficult problems.
But when Klein accepted his job as a public servant, other activities became incompatible. One of those is directing a lobbying group that operates in the same area as CIRM.
As we reported earlier, Klein's dual roles represent an inherent conflict of interest. It is as if a high level executive with the California Medical Association also served on the state Medical Board. It is impossible to know whether their official actions represent their own views or the views of the special interest group.
Monday, July 28, 2008
CIRM Confirms Departure of General Counsel
The California stem cell agency today confirmed that Tamar Pachter is leaving her post (see item below) as general counsel of the $3 billion enterprise.
Her Aug. 15 departure pretty much finishes off the senior management team assembled by former President Zach Hall, who retired in the spring of 2007. The top senior executives now in place were brought in after Hall left and after Chairman Robert Klein recruited Alan Trounson as president.
Under Klein's leadership, CIRM has also been reorganized to shift more staff and responsibility to the chairman's office, undoing directors' changes in 2007 that stripped Klein's office of six positions.
Klein and Hall butted heads more than once, mostly in private, but in public put the best face on their relationship. Conflicts emerged partly because of the overlapping roles provided for president and chairman in Prop. 71. Under normal state and business practices those roles could be clarified by an organization's board of directors, but Prop. 71 locks them into state law, making them virtually impossible to change. The differences between the men, however, went beyond the CIRM structure, reflecting their divergent personalities, professional background and philosophies.
In response to a query from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, confirmed Pachter's resignation. He said she would return to the state Department of Justice, where she served as a deputy attorney general. It was in that position that she argued and won the case that threatened to put CIRM out of business.
Her Aug. 15 departure pretty much finishes off the senior management team assembled by former President Zach Hall, who retired in the spring of 2007. The top senior executives now in place were brought in after Hall left and after Chairman Robert Klein recruited Alan Trounson as president.
Under Klein's leadership, CIRM has also been reorganized to shift more staff and responsibility to the chairman's office, undoing directors' changes in 2007 that stripped Klein's office of six positions.
Klein and Hall butted heads more than once, mostly in private, but in public put the best face on their relationship. Conflicts emerged partly because of the overlapping roles provided for president and chairman in Prop. 71. Under normal state and business practices those roles could be clarified by an organization's board of directors, but Prop. 71 locks them into state law, making them virtually impossible to change. The differences between the men, however, went beyond the CIRM structure, reflecting their divergent personalities, professional background and philosophies.
In response to a query from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, confirmed Pachter's resignation. He said she would return to the state Department of Justice, where she served as a deputy attorney general. It was in that position that she argued and won the case that threatened to put CIRM out of business.
CIRM's Chief Counsel Quits
The attorney who successfully defended the California stem cell agency against challenges to its existence has resigned as CIRM general counsel after only 16 months on the job, according to a well-informed source. One longtime observer of CIRM affairs characterized the reported resignation of Tamar Pachter(pictured) as a "troubling development" that reflects poorly on CIRM Chairman Robert Klein.
Pachter could not be reached for comment on her decision to leave her $225,000-a-year post. CIRM has not responded to our queries on her resignation.
Pachter is at least the 17th employee to leave CIRM since it began work in 2005. The agency has only slightly more than 30 employees with plans to reach 39 by the end of this fiscal year.
Only last December Pachter received a 41 percent pay increase, up from the $160,000 that she was hired at in March 2007.
Rumblings have surfaced, however, that Pachter was not happy. One likely issue is the fragmented legal approach at CIRM. Typically a general counsel oversees all the legal operations of a state agency or business. However, that was clearly not the case at CIRM.
The agency has retained outside counsel, Remcho, Johansen & Purcell of San Leandro, Ca., since 2005 at a cost exceeding $1 million. CIRM has at least three other attorneys, not including Pachter and Chairman Klein, who wrote much of Prop. 71, the ballot measure that created the agency. None of those attorneys reported to Pachter, according to CIRM's organizational chart. Instead they come under Klein.
CIRM plans to hire two more attorneys this year. Neither of them is linked directly to the general counsel's office. CIRM also has received legal assistance from the state Department of Justice.
Frequently Pachter and James Harrison, Remcho's main CIRM representative, would attend the same CIRM public meetings. Often, Klein deferred to Harrison at those sessions. The Harrison/Remcho contract is due to be renewed on Wednesday for $450,000 for 2008-09 at rates up to $350 an hour.
We asked John M. Simpson, stem cell project director for the Consumer Watchdog group of Santa Monica, Ca., for his thoughts on Pachter's departure. Simpson recently commented on how CIRM's top management seems to be an "old boys' club."
Simpson said,
"If Tamar Pachter has resigned, it is a troubling development. CIRM has been plagued with high turnover and much of the blame for this rests with the management style of Chairman Bob Klein. The agency has lurched too frequently in different directions; what's needed is a steady hand at the helm that allows the routine to become routine."When Pachter was hired out of a pool of nearly 100 applicants, CIRM hailed her "impeccable legal credentials" and described her as a "superb litigator."
Thursday, July 24, 2008
Bee 'Flabbergasted' by Klein's Actions
The Sacramento Bee has not been pleased with Robert Klein virtually since he became chairman of the $3 billion California stem cell agency more than three years ago.
Earlier this week, the newspaper fired off another editorial lambasting Klein, this time accusing of him of misusing his office.
The case in point involves Klein's personal stem cell lobbying group, Americans for Cures, which recently publicly excoriated an offending state legislator in a posting on a widely read, national political blog.
The Bee wrote,
As far as Klein's reported resignation as president of Americans for Cures, so far no official announcement has been forthcoming. One report had it that the resignation would be announced after he told Sen. Sheila Kuehl, the object of his group's ire, about it. But her office said that Klein did not mention resigning in their conversation following the offending Internet post.
The delay in announcing his resignation may indicate that the earlier resignation reports amounted to something of a trial balloon effort by Klein in which Klein expected supporters to rally around him. Meanwhile, he is still listed as president on the Americans for Cures website.
Earlier this week, the newspaper fired off another editorial lambasting Klein, this time accusing of him of misusing his office.
The case in point involves Klein's personal stem cell lobbying group, Americans for Cures, which recently publicly excoriated an offending state legislator in a posting on a widely read, national political blog.
The Bee wrote,
"Through his connections with the governor and other state leaders, Klein effectively directs who is appointed to the institute's 29-member oversight board, which includes university deans dependent on research funds that Klein controls.The Bee continued:
"That should be enough power for any one public official. But not for Klein.
"Up until last week, Klein also served as president of Americans for Cures, an advocacy group that works out of offices he owns in Palo Alto. That linkage provides Klein with a nongovernmental agent with which to go after his opponents and further his institutional power."
"Government officials shouldn't be affiliated with special interest groups that lobby on issues that affect their agencies. After three years, it remains flabbergasting that Klein doesn't recognize that conflict and the injury it causes to the state's stem cell program. Even more curious is why the institute's 'oversight' board continues to condone it."The Bee's editorial was written before the disclosure that Klein plans to spend 88 days traveling out of state this fiscal year at taxpayer expense. We are certain that the newspaper would have been even more exercised if that had been known at the time the editorial was written.
As far as Klein's reported resignation as president of Americans for Cures, so far no official announcement has been forthcoming. One report had it that the resignation would be announced after he told Sen. Sheila Kuehl, the object of his group's ire, about it. But her office said that Klein did not mention resigning in their conversation following the offending Internet post.
The delay in announcing his resignation may indicate that the earlier resignation reports amounted to something of a trial balloon effort by Klein in which Klein expected supporters to rally around him. Meanwhile, he is still listed as president on the Americans for Cures website.
Lockyer Names Quint to CIRM Directorate
The California stem cell agency has a new member on its board of directors, a cardiologist from San Jose who once treated former state lawmaker John Vasconcellos.
The new member of the CIRM Oversight Committee is Robert Quint, who was appointed to the post by state Treasurer Bill Lockyer.
A spokesman for Lockyer said Vasconcellos had recommended Quint. "We were highly impressed with Quint's resume, and the man himself, and Lockyer decided he was the person for the job." the spokesman said. Lockyer and Vasconcellos, both Democrats, served in the state legislature together.
Quint replaces Janet Wright, also a cardiologist, on the 29-member board. Wright left earlier this year to take a job in Washington, D.C., with the American College of Cardiology.
Quint has operated his own cardiology practice in San Jose since 1980. Lockyer's office said,
The new member of the CIRM Oversight Committee is Robert Quint, who was appointed to the post by state Treasurer Bill Lockyer.
A spokesman for Lockyer said Vasconcellos had recommended Quint. "We were highly impressed with Quint's resume, and the man himself, and Lockyer decided he was the person for the job." the spokesman said. Lockyer and Vasconcellos, both Democrats, served in the state legislature together.
Quint replaces Janet Wright, also a cardiologist, on the 29-member board. Wright left earlier this year to take a job in Washington, D.C., with the American College of Cardiology.
Quint has operated his own cardiology practice in San Jose since 1980. Lockyer's office said,
"He has helped develop pioneering diagnostic and treatment techniques for arteriosclerotic heart disease, including coronary angiography and angioplasty."We asked Lockyer's office whether Quint had been recommended by CIRM Chairman Robert Klein. Spokesman Tom Dresslar replied,
"Former state legislator John Vasconcellos did. He and Lockyer go way back."One vacancy remains on the CIRM board of directors.
Wednesday, July 23, 2008
CIRM Mulls Kuehl Legislation Once Again, Supplier Proposal Also on Table
A directors subcommittee of the California stem cell agency will discuss on Thursday their opposition to legislation aimed at ensuring affordable access to state-financed stem cell therapies.
The bill is only two steps away from being sent to the governor's desk. No lawmaker has voted against the measure, SB 1565 by state Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It is now on the the Assembly floor. If it wins approval as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.
CIRM has officially opposed the measure, and it is not clear what its Legislative Subcommittee might do at the Thursday afternoon meeting, short of renewing the agency's opposition. Interested parties can participate or listen in on the meeting at public teleconference locations throughout the state, including San Francisco, Elk Grove, Irvine, Healdsburg, Sacramento and Palo Alto.
The meeting comes as BioRegion News is carrying a lengthy look at the bill, its support and opposition. Written by Alex Philippidis, the piece quotes Kuehl as saying regarding CIRM,
Currently the bill is in the Senate Appropriations Committee and is scheduled for a hearing Aug. 4. CIRM is also proceeding with its own regulatory definition of California supplier. The legislation has been the subject of considerable negotiation. Movement by CIRM may well come at the Thursday meeting. Here is a link to the latest amended version of the bill, although it may not reflect more current drafts that are not available on the Internet.
The bill is only two steps away from being sent to the governor's desk. No lawmaker has voted against the measure, SB 1565 by state Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It is now on the the Assembly floor. If it wins approval as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.
CIRM has officially opposed the measure, and it is not clear what its Legislative Subcommittee might do at the Thursday afternoon meeting, short of renewing the agency's opposition. Interested parties can participate or listen in on the meeting at public teleconference locations throughout the state, including San Francisco, Elk Grove, Irvine, Healdsburg, Sacramento and Palo Alto.
The meeting comes as BioRegion News is carrying a lengthy look at the bill, its support and opposition. Written by Alex Philippidis, the piece quotes Kuehl as saying regarding CIRM,
"They don’t intend to remove their opposition. They simply want more, and more, and more amendments, because they want the bill to go away. But the bill is not going away."Also up for discussion at the Thursday meeting is the California supplier bill, AB 2381 by Assemblyman Gene Mullin, D-San Mateo. That bill would define California supplier for the purposes of providing a preference to such businesses as required by Prop. 71.
Currently the bill is in the Senate Appropriations Committee and is scheduled for a hearing Aug. 4. CIRM is also proceeding with its own regulatory definition of California supplier. The legislation has been the subject of considerable negotiation. Movement by CIRM may well come at the Thursday meeting. Here is a link to the latest amended version of the bill, although it may not reflect more current drafts that are not available on the Internet.
Fresh Comments
Larry Ebert has posted a comment on the "group-think" item. "Anonymous" has filed a comment on the "WARF whacked" item.
Tuesday, July 22, 2008
The Perils of Group-Think at CIRM
Is the California stem cell agency dominated by an Old Boys Club that is shy on experience in running a grant program totalling a half-billion dollars?
John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., thinks so.
Simpson, who describes himself as a "fat, old white guy," says he doesn't have anything against such persons. But he warns about the perils of group-think when the top execs are cut from the same general mold.
Only one woman and no minorities hold top management positions at CIRM, which Simpson lists as chairman, vice chairman, president, vice president, chief scientific officer and chief communications officer.
Writing on his organization's blog, Simpson sees the hiring of John A. Robson of McGill as part of the influence of CIRM's old boys. Simpson cites the role of Richard Murphy, former CIRM director, former interim president and ongoing consultant, in recruiting Robson. Murphy also once worked at McGill.
Simpson also notes that former CIRM acting president Lori Hoffman had a falling out with Chairman Robert Klein last year and was "pushed out."
Simpson writes that with Zach Hall as president and Arlene Chiu as chief scientific officer, CIRM "had extensive experience on the grant-making and management side of the equation by virtue of their time at the National Institutes of Health. They knew something about holding grantees accountable."
Simpson continues,
John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., thinks so.
Simpson, who describes himself as a "fat, old white guy," says he doesn't have anything against such persons. But he warns about the perils of group-think when the top execs are cut from the same general mold.
Only one woman and no minorities hold top management positions at CIRM, which Simpson lists as chairman, vice chairman, president, vice president, chief scientific officer and chief communications officer.
Writing on his organization's blog, Simpson sees the hiring of John A. Robson of McGill as part of the influence of CIRM's old boys. Simpson cites the role of Richard Murphy, former CIRM director, former interim president and ongoing consultant, in recruiting Robson. Murphy also once worked at McGill.
Simpson also notes that former CIRM acting president Lori Hoffman had a falling out with Chairman Robert Klein last year and was "pushed out."
Simpson writes that with Zach Hall as president and Arlene Chiu as chief scientific officer, CIRM "had extensive experience on the grant-making and management side of the equation by virtue of their time at the National Institutes of Health. They knew something about holding grantees accountable."
Simpson continues,
"The Old Boys Club members' experience has been on the grant-receiving side -- and most of that in academia. Certainly some of the top executives at an agency charged with handing out $3 billion in scientific grants should have experience on the grant-making side. It's almost as if the henhouse is being taken over by the foxes."Simpson concludes:
"I fear the Old Boys Club is letting visions of playing on the international stage distract them from what is really CIRM's charge: Funding vital research and finding cures in California. The real danger of a having a management team that looks alike is that team members will think alike. Nobody will stand up and say, 'Wait a minute; just what are we doing here and why?'"
Fresh Comment
Marcy Darnovsky of the Center for Genetics and Society in Oakland, Ca., has filed a comment on the "no egg shortage" item.
Monday, July 21, 2008
Fresh Comments
Larry Ebert has posted a comment on "WARF Whacked Again."
Angsuman Chakraborty has posted a comment on "Stem Cell Globe-Trotting."
Angsuman Chakraborty has posted a comment on "Stem Cell Globe-Trotting."
A Re-Look at Friday's Egg Meeting
The California stem cell agency has taken issue with the way we have framed this coming Friday's meeting dealing with human eggs.
It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.
Geoff Lomax, senior officer for the Standards Working Group, said,
When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.
But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.
He wrote:
It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.
Geoff Lomax, senior officer for the Standards Working Group, said,
"You have got this one completely wrong and framed the meeting in a sensational and inflammatory way which does a disservice to thoughtful policy deliberations."Lomax prepared the briefing paper – called "Use of Embryos Created for Reproductive Purposes with Paid Gametes" – for use at the Standards meeting later this week.
When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.
But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.
He wrote:
"Nationally, the CIRM policy deviates from other jurisdictions that have developed policies to advance stem cell research. This deviation has raised concerns over the ability of CIRM researchers to utilize materials derived under other jurisdictional policies or the National Academies Guidelines."The issue of the use of human eggs is freighted with emotional and political baggage, plenty of which will surface eventually. But meantime, Lomax is trying to lay the groundwork for a straightforward consideration of practical issues that need attention sooner rather than later.
San Diego Researchers Say No Shortage of Human Eggs
Jeff Sheehy, a member of the board of directors of the California stem cell agency, has brought to the human egg debate a new entry that appears to fly in the face of assertions that scientists cannot get enough eggs for their human embryonic stem cell research.
His comments and information come as the CIRM Standards Working Group plans to dig into the topic again this Friday during a public hearing in Los Angeles. The issue of egg availability, however, goes well beyond California, reaching out to such places as the United Kingdom, where discounted IVF services are being offered to generate eggs for research.
Sheehy, also a member of the Standards Working Group, pointed to work being done by Cascade LifeSciences in San Diego and others to show that the egg shortage concerns of CIRM President Alan Trounson and Harvard's Kevin Eggan may be overstated.
Sheehy's starting point is a letter for reconsideration of Cascade's rejected application for a CIRM grant. Cascade's letter, which can be found here on the California Stem Cell Report, stated that the firm was collaborating with David Smotrich of the La Jolla IVF clinic to obtain eggs. Cascade said that the clinic had a "list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to homornal stimulation."
Last week Sheehy queried Ken Woolcott, who wrote the reconsideration request, about the availability of eggs, which Sheehy recalled as being 100 a year. Sheehy also asked whether they were obtained under circumstances that would make them available for use by CIRM grantees i.e. proper consent, no payment outside of CIRM policy, etc.
In response, Woolcott, Cascade's chief business officer, emailed Sheehy that he checked with Cascade's primary investigator, Dr. Sophia Khaldoyanidi, as well as Smotrich, head of the collaborating La Jolla IVF clinic. Woolcott replied,
But the devil may well be in the details. In this case, does the La Jolla clinic's definition of reimbursement for "time and medical care expenses" match that of CIRM's?
His comments and information come as the CIRM Standards Working Group plans to dig into the topic again this Friday during a public hearing in Los Angeles. The issue of egg availability, however, goes well beyond California, reaching out to such places as the United Kingdom, where discounted IVF services are being offered to generate eggs for research.
Sheehy, also a member of the Standards Working Group, pointed to work being done by Cascade LifeSciences in San Diego and others to show that the egg shortage concerns of CIRM President Alan Trounson and Harvard's Kevin Eggan may be overstated.
Sheehy's starting point is a letter for reconsideration of Cascade's rejected application for a CIRM grant. Cascade's letter, which can be found here on the California Stem Cell Report, stated that the firm was collaborating with David Smotrich of the La Jolla IVF clinic to obtain eggs. Cascade said that the clinic had a "list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to homornal stimulation."
Last week Sheehy queried Ken Woolcott, who wrote the reconsideration request, about the availability of eggs, which Sheehy recalled as being 100 a year. Sheehy also asked whether they were obtained under circumstances that would make them available for use by CIRM grantees i.e. proper consent, no payment outside of CIRM policy, etc.
In response, Woolcott, Cascade's chief business officer, emailed Sheehy that he checked with Cascade's primary investigator, Dr. Sophia Khaldoyanidi, as well as Smotrich, head of the collaborating La Jolla IVF clinic. Woolcott replied,
"Dr. Smotrich confirmed that the oocyte donors are only reimbursed for their time and medical care expenses. These donors are not IVF patients that receive discounts or are paid for their eggs. They tend to be donors that desire to enhance medical research in the Stem Cell area, are younger and have a track record of high oocyte quality and productivity.Sheehy said that Woolcott's information is "very important" if it "confirms that at least one investigator in California is able to obtain sufficient oocytes to conduct research within the confines of CIRM's ethical standards and the provisions of Prop. 71 and SB 1260(the law that deals with non-CIRM funded hESC research)."
"I believe that this is consistent with the draft guidelines prepared by CIRM and is consistent with the law in California. More importantly, any work in this area would be subject to IRB approval."
But the devil may well be in the details. In this case, does the La Jolla clinic's definition of reimbursement for "time and medical care expenses" match that of CIRM's?
Friday, July 18, 2008
A Critical Look at CIRM's Stem Cell Globe-Trotting
The Consumer Watchdog group is taking a dim view of the travel plans of the top executives of the California stem cell agency, describing as "bafflegab" the justification for spending much of the $558,000 in what CIRM describes as its "other travel" budget.John M. Simpson, stem cell project director for the non-profit advocacy group, made his comments on his organization's blog. They were based on previously undisclosed documents that he requested from CIRM.
Among other things, the CIRM documents showed that its chairman, Bob Klein(pictured), is scheduled to be outside of California for 88 days at state expense in 2008-09. That does not include his travel within California, such as his trip today to Santa Barbara.
Chief Science Office Marie Csete will be out of California 75 days, CIRM President Alan Trounson 68 days, Chief Communications Officer Don Gibbons 32 days. All of which amounts to a 287 percent increase (in terms of dollars) in "other travel" by CIRM officials.
China, Japan, the United Arab Emirates, Israel, the United Kingdom, Sweden, The Netherlands, France, Korea, Australia, Italy, South Africa and Canada are among the destinations.
To a CIRM travel justification that said in part that some of the trips were necessary "in order to have an integrated picture of state of the art and forward-looking research agendas," Simpson retorted, "bafflegab."
He continued,
"After crunching the numbers I checked with some scientists. All agreed there is a need for the hard-working science staff to attend some conferences to stay abreast of the latest developments. Perhaps one or two a year, suggested one.Still undisclosed, as far as we can tell, are travel expenses that are not classified as "other travel."
"Another scientist reported traveling 4-5 days a month to to give seminars, attend meetings and review grants and then said about CIRM's travel plans:
"'Is the travel necessary? No. Useful for CIRM? Probably not very much. Good for Bob and Alan? Absolutely.'
"Voters passed Proposition 71 because they wanted to pay for vital stem cell research in California that the federal government would not fund. They did not intend to send Bob Klein around the world as a stem cell research advocate."
Simpson has posted the documents in question on his website. Links to them are contained in his blog.
CIRM Reviews the Business of Human Eggs
One week from today, the California stem cell agency is going to dig into the hot topic of human eggs – how many can scientists can get and their cost. To its credit, the agency has posted background material on the subject well in advance of the July 25 meeting of its Standards Working Group in Los Angeles. Providing the material early is a refreshing change from CIRM's recent dilatory practices. The agency is to be commended.
The egg meeting comes in the wake of complaints earlier this year by researchers and CIRM President Alan Trounson that human eggs were not to be had in sufficient quantities for research. Kevin Eggan(pictured) of Harvard, a member of the Standards group, said that he and his colleagues had spent $100,000 advertising for human egg donors with little success.
The problem is that California and other states bar compensation for eggs for research. But handsome payments -- $15,000 and even more -- are made by IVF clinics for the same egg donation process. So most women take the cash.
Eggan made his comments last February. The ensuing discussion set in motion a review of CIRM policies dealing with compensation of donors. The issue also came up briefly last month at the meeting of the CIRM board of directors.
Trounson said scientists are having a "terrible time" securing eggs. He declared,
"It's all because there's no partnershipping arrangements or because they're using very few oocyte material. They're now trying to use cattle eggs, other species. They're floundering."CIRM has prepared a draft briefing paper dealing with the egg issue. The agency has not completed all of its work on the subject, but it is surveying funding institutions, interviewing scientists and others and determining whether specific cell lines are not being used by CIRM grantees.
The briefing paper lists the following policy questions.
"Should CIRM funded researchers be able to use 'outside' hESC lines if they are derived from IVF-embryos created with paid gametes?Also prepared for next week's meeting is a briefing paper on uses of cell lines derived prior to CIRM regulations.
"Should CIRM funded researchers be able to utilize hESC lines derived from IVF-embryos created with paid gametes under an 'authorized authority'?
"Should CIRM funded researchers be be able to utilize IVF-embryos created with
paid gametes to derive new lines?"
WARF Whacked Again
The latest chapter in the WARF stem cell patent saga opened today with the filing of an appeal by two consumer groups and a statement from California researcher Jeanne Loring of the Scripps Institute. She said,
Simpson said,
"It's not just scientists that are affected by the patents. Patients and their families know that WARF’s iron-fisted control of stem cells is slowing life-saving research."Consumer Watchdog of Santa Monica, Ca., and the Public Patent Foundation in New York City announced the filing of the appeal. The issue is not likely to be resolved for years, although John M. Simpson of Consumer Watchdog said WARF has already relaxed its licensing requirements in the wake of the patent challenge.
Simpson said,
"WARF executives were acting like arrogant bullies blinded by dollar signs. Our challenge has engendered a more co-operative stance towards the stem cell research community on their part."
Thursday, July 17, 2008
Kindling the Flame in Goleta: Thomson, Klein Part of Gaucho Show
California's Robert Klein will share the stage with Wisconsin's Jamie Thomson Friday at the University of California, Santa Barbara, which has lured the renown researcher to its seaside campus with a $1 million package, including a new lab.Klein, of course, is both the chairman of California's $3 billion stem cell agency and still officially president of his own private stem cell lobbying group, Americans for Cures. (No announcement has been forthcoming from the group confirming his reported resignation in the wake of its vitriolic attack on an influential state legislator.)
Klein and Thomson (pictured) will appear as part of a town hall event to discuss the state of stem cell research. The roundtable will also feature Congresswoman Lois Capps, a former nursing instructor, Gaucho (as UCSB denizens are known) alum and Wisconsin native.
CIRM has had a huge impact in California stem cell circles in the last 3 ½ years, but UC Santa Barbara might well be a poster child for what the agency has achieved.
Human embryonic stem cell research hardly existed on the campus (pictured) prior to 2005, the first full year for the California's research effort. But with a strong push from professor Dennis Clegg, now co-director of the UCSB Center for Stem Cell Biology and Engineering, the school scored in the first round of grants approved by CIRM. Today it has $6.7 million in stem cell research and lab construction funds from the California stem cell agency and another $3 million from one of the founders of Amgen. And it succeeded in drawing Thomson into the state on a part-time basis.
Thomson, whose lab is located in the UCSB California NanoSystems Institute, says,
"I am attracted by UCSB's strengths in materials science, instrumentation, and by the availability of marine model organisms for comparative studies."Of course, UCSB's $6.7 million in CIRM funding is eclipsed by the $91 million given by CIRM to Stanford and the $69 million to UC San Francisco. But those campuses can generate buckets of money even without the state cash.
The Santa Barbara university has this to say about its fledgling stem cell effort:
"UCSB is well positioned to make unique, significant contributions in stem cell research, with extraordinary enabling technologies in biomaterials, systems biology, nanotechnology, micro-processing and bioengineering, all of which are synergistic with fundamental biomedical research efforts. Our approaches are uniquely distinct from those at California medical schools, with our emphasis on basic biological questions and engineering challenges related to stem cell research."What CIRM has done is kindle a flame in Goleta (the actual location of UCSB). The hope is that the UCSB effort will grow and prosper, bringing new initiatives and insights into development of possible stem therapies.
Wednesday, July 16, 2008
Stem Cell Affordability Bill Marches Towards Schwarzenegger
Legislation aimed at ensuring affordable access to any therapies developed as the result of California's $3 billion stem cell research program today easily cleared its final committee hurdle and appears likely to wind up on the desk of Gov. Arnold Schwarzenegger.
The measure (SB 1565) by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, was sent to the Assembly floor by the Assembly Appropriations Committee. Presuming it wins Assembly approval, it will go back to the Senate for concurrence in Assembly amendments. No lawmaker has voted against the bill, nor did any today although the final official vote is not yet available.
The bill has faced sometimes vitriolic opposition, particularly from the private lobbying group of the chairman of the state's stem cell research effort, Robert Klein. Americans for Cures lambasted Kuehl as "ignorant" and "craven" in a posting on the Daily Kos, a political blog with about 1 million page views a day.
Americans for Cures, which operates out of the same address as Klein's real estate investment banking firm, later apologized and asked that the offending item be removed. Klein said he did not know about the item. He is reportedly resigning as president of Americans for Cures, but it is not clear whether he will sever all ties or whether the organization will move from his offices.
Klein's connection to the lobbying group, which is an offshoot of the Prop. 71 campaign organization, has long triggered criticism because of concerns about conflicting interests.
One commentator, who must remain anonymous, told the California Stem Cell Report today:
The next lobbying target for CIRM and the stem cell activists is the governor, who can veto the legislation and who has been more than receptive towards the stem cell agency's efforts.
Here is a link to the latest legislative staff analysis of the bill.
The measure (SB 1565) by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, was sent to the Assembly floor by the Assembly Appropriations Committee. Presuming it wins Assembly approval, it will go back to the Senate for concurrence in Assembly amendments. No lawmaker has voted against the bill, nor did any today although the final official vote is not yet available.
The bill has faced sometimes vitriolic opposition, particularly from the private lobbying group of the chairman of the state's stem cell research effort, Robert Klein. Americans for Cures lambasted Kuehl as "ignorant" and "craven" in a posting on the Daily Kos, a political blog with about 1 million page views a day.
Americans for Cures, which operates out of the same address as Klein's real estate investment banking firm, later apologized and asked that the offending item be removed. Klein said he did not know about the item. He is reportedly resigning as president of Americans for Cures, but it is not clear whether he will sever all ties or whether the organization will move from his offices.
Klein's connection to the lobbying group, which is an offshoot of the Prop. 71 campaign organization, has long triggered criticism because of concerns about conflicting interests.
One commentator, who must remain anonymous, told the California Stem Cell Report today:
"I would say it's an inherent conflict to be an officer of any kind of 'Cures,' while being on the ICOC (the board of directors of the stem cell agency). It would be like a physician who is a high level officer in the California Medical Association being on the (state) Medical Board. One would never know whether their official actions represented their own views or the views of the CMA."Americans for Cures has not yet confirmed that Klein is resigning. (Shortly after this item was posted, we saw a report on the Niche stem cell blog of Nature magazine saying that Americans said Klein has resigned but will remain on the lobbying group's board, which probably means that it will continue to be housed at Klein's offices.)
The next lobbying target for CIRM and the stem cell activists is the governor, who can veto the legislation and who has been more than receptive towards the stem cell agency's efforts.
Here is a link to the latest legislative staff analysis of the bill.
CGS Says CIRM Legislation is 'Gentle'
The Center for Genetics and Society says the stem cell measure now before the California legislature would only "gently alter" affairs at the state's $3 billion stem cell research effort.
The group's comments came as as more activity surfaced concerning the measure, SB 1565, which comes before the Assembly Appropriations Committee today. It has sailed through the legislature without a dissenting vote despite fierce – sometimes scathing – opposition from stem cell advocates.
Commenting on the center's blog, Biopolitical Times, Jesse Reynolds said that CIRM's board of directors is engaging in "histrionics" and opposes the measure even though it would give them more flexibility.
Reynolds, who wrote presciently nearly four years ago about some of the problems that have surfaced at CIRM, commented Tuesday that the agency
Reynolds' postings came as patient advocate Don Reed, vice president of Americans for Cures (the private lobbying group of CIRM Chairman Robert Klein), wrote on the influential Daily Kos political blog about the measure. He urged readers to lobby against the bill and send "hard copy" letters to the governor, asking him to veto the proposal.
Also, James Kovach, president of the Buck Institute in Novato, Ca., sent a letter to a member of the Assembly Appropriations Committee, declaring the organization's opposition to the Kuehl bill. He said it would disrupt embryonic stem cell research. The full text of the letter follows in a separate item below.
The group's comments came as as more activity surfaced concerning the measure, SB 1565, which comes before the Assembly Appropriations Committee today. It has sailed through the legislature without a dissenting vote despite fierce – sometimes scathing – opposition from stem cell advocates.
Commenting on the center's blog, Biopolitical Times, Jesse Reynolds said that CIRM's board of directors is engaging in "histrionics" and opposes the measure even though it would give them more flexibility.
Reynolds, who wrote presciently nearly four years ago about some of the problems that have surfaced at CIRM, commented Tuesday that the agency
"... can fund any biomedical research if a two-thirds supermajority of its grants review working group approves. The current Senate bill would lower that bar to a simple majority.Reynolds' "gently alter" remark appeared in a related posting that said that Klein's apparent resignation as president of his lobbying group, Americans for Cures, was long overdue. A CIRM spokesman said on Monday that Klein had resigned, but deferred any further comment to Americans for Cures. That group has not responded to repeated requests for confirmation of the Klein resignation.
"This would not restrict the CIRM in any way. If anything, the bill simply gives the CIRM more flexibility. Considering that the grants working group generally operates by consensus, that the governing board must approve all grants, and that the CIRM currently generously supports non-embryonic stem cell research, the amendment would have zero practical impact.
"Nevertheless, the board worked itself into histrionics over any concession to the development of alternatives."
Reynolds' postings came as patient advocate Don Reed, vice president of Americans for Cures (the private lobbying group of CIRM Chairman Robert Klein), wrote on the influential Daily Kos political blog about the measure. He urged readers to lobby against the bill and send "hard copy" letters to the governor, asking him to veto the proposal.
Also, James Kovach, president of the Buck Institute in Novato, Ca., sent a letter to a member of the Assembly Appropriations Committee, declaring the organization's opposition to the Kuehl bill. He said it would disrupt embryonic stem cell research. The full text of the letter follows in a separate item below.
Text of Buck Institute Letter on SB 1565
Here is the text of a July 15 letter to Assemblyman Jared Huffman, a member of the Assembly Appropriations Committee, from the Buck Institute, opposing legislation aimed at ensuring affordable access to state-financed stem cell therapies.
Dear Assemblyman Huffman,
Thank you for the opportunity to comment on SB 1565. We understand that SB 1565 will be heard before the Appropriations Committee on Wednesday, July 16th, at the Sacramento Capitol. As this will be the last full committee hearing on SB 1565, before it goes to the Assembly floor, on behalf of the Buck Institute I would like to provide you with our view of this proposed bill.
We strongly oppose SB 1565. Our reading of the proposed changes led us to conclude that the changes are unnecessary and, if adopted, would likely have several negative consequences. Our primary objections are set forth below:
The scientific review committees are represented by specialists in stem cell research. They are already tasked with reviewing many excellent applications for funding of research in the stem cell arena. It is important work done on often grueling schedules and any requests to evaluate “vitally important research” not associated with stem cell and/or stem cell related work will distract their attention from the work they were specifically chosen to perform. We believe the purpose of Proposition 71 will be altered by the amendment and moreover, alter the mission of the scientific review committees.
We believe the proposed amendment will disrupt the conduct of human embryonic stem cell research as set forth in Proposition 71, the Constitution of the State of California and the will of a majority of the voters in California. If passed, the proposed amendment would alter the will of the people without their consent.
The potential change in the direction of stem cell research funding would come at a crucial juncture in the development of the CIRM. The development of the CIRM has been guided by the principles embodied in Proposition 71 and is just beginning to apply its full attention to stem cell research funding rather than the startup activities and infrastructure development of the largest and singularly unique enterprise of its kind.
The CIRM has been under virtually constant scrutiny from its inception. Our experiences with the CIRM and its staff have not always turned out as we had hoped but we have never had reason to question the CIRM’s dedication to fulfillment of the intentions of Proposition 71. We see no benefit in adding more layers of scrutiny to an already transparent organization.
The fair pricing sections proposed by SB 1565 are redundant to administrative procedures that we have seen first hand to be working to ensure that all Californians benefit from therapies developed by Proposition 71.
With the above in our thoughts, we ask that you oppose the passage of SB 1565.
For the sake of completeness, I have attached a cogent editorial written by a colleague, Don Reed. http://www.dailykos.com/story/2008/7/15/111757/794?new=true
Please feel free to contact me with any questions or desire any clarification of our position on SB1565.
Jim
Jim Kovach, M.D., J.D.
President & COO
Buck Institute for Age Research
Dear Assemblyman Huffman,
Thank you for the opportunity to comment on SB 1565. We understand that SB 1565 will be heard before the Appropriations Committee on Wednesday, July 16th, at the Sacramento Capitol. As this will be the last full committee hearing on SB 1565, before it goes to the Assembly floor, on behalf of the Buck Institute I would like to provide you with our view of this proposed bill.
We strongly oppose SB 1565. Our reading of the proposed changes led us to conclude that the changes are unnecessary and, if adopted, would likely have several negative consequences. Our primary objections are set forth below:
The scientific review committees are represented by specialists in stem cell research. They are already tasked with reviewing many excellent applications for funding of research in the stem cell arena. It is important work done on often grueling schedules and any requests to evaluate “vitally important research” not associated with stem cell and/or stem cell related work will distract their attention from the work they were specifically chosen to perform. We believe the purpose of Proposition 71 will be altered by the amendment and moreover, alter the mission of the scientific review committees.
We believe the proposed amendment will disrupt the conduct of human embryonic stem cell research as set forth in Proposition 71, the Constitution of the State of California and the will of a majority of the voters in California. If passed, the proposed amendment would alter the will of the people without their consent.
The potential change in the direction of stem cell research funding would come at a crucial juncture in the development of the CIRM. The development of the CIRM has been guided by the principles embodied in Proposition 71 and is just beginning to apply its full attention to stem cell research funding rather than the startup activities and infrastructure development of the largest and singularly unique enterprise of its kind.
The CIRM has been under virtually constant scrutiny from its inception. Our experiences with the CIRM and its staff have not always turned out as we had hoped but we have never had reason to question the CIRM’s dedication to fulfillment of the intentions of Proposition 71. We see no benefit in adding more layers of scrutiny to an already transparent organization.
The fair pricing sections proposed by SB 1565 are redundant to administrative procedures that we have seen first hand to be working to ensure that all Californians benefit from therapies developed by Proposition 71.
With the above in our thoughts, we ask that you oppose the passage of SB 1565.
For the sake of completeness, I have attached a cogent editorial written by a colleague, Don Reed. http://www.dailykos.com/story/2008/7/15/111757/794?new=true
Please feel free to contact me with any questions or desire any clarification of our position on SB1565.
Jim
Jim Kovach, M.D., J.D.
President & COO
Buck Institute for Age Research
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