One of the famous examples of excess during California's 1849 Gold Rush was the price of eggs, something over a dollar each, according to legend.
Today the price of eggs is being set by the California stem cell agency – at least the price of human eggs from women.
That price appears to be zero.
No real surprise there because Prop. 71 banned payment for human eggs except for direct expenses. But some folks are not entirely happy.
Reporter Edie Lau of The Sacramento Bee wrote about the egg economics earlier this month. She said that Robert Klein, chairman of the stem cell agency, said "the payment ban was intended as a safeguard against women - especially poor women - feeling pressured or enticed to sell their eggs." He said employers should help out.
Lau reported on a meeting of the Scientific and Medical Accountability Standards Working Group of the stem cell agency, formally known as the California Institute for Regenerative Medicine.
She wrote that some witnesses were not pleased with CIRM's position.
"'I don't know why you put (yourselves) in a position to not compensate for time and effort,' said Jose Cibelli, a stem cell researcher at Michigan State University. 'It's something you will come to regret.'
"Ann Kiessling, a Harvard University biologist who runs an independent, nonprofit center that solicits egg donors specifically for stem cell research, predicted that some women who wish to provide eggs will be unable to if, for example, they aren't reimbursed for lost wages.
"'All normal, healthy subjects that undergo any research in this country are compensated for their time,' she said."
Lau continued:
"Klein, who also sits on the standards working group, did not respond to criticism of the rule during the meeting, but said in an interview that the prohibition cannot be changed, nor should it.
"'It is a more challenging provision, but it provides us with a higher ethical standard,'" Klein said.
"He said he hopes employers will support employees who wish to donate eggs, and continue to pay them as some employers do for jury duty. 'It's a public service to society,' Klein said."
You don't have to be Milton Friedman (the Nobel-winning free market economist who lives in San Francisco) to understand that if human eggs become sought after, their price will rise, regardless of Prop. 71. Another human product -- blood -- is purchased regularly at very low prices, but it is a common commodity. The market for human eggs and their price are yet to be determined. But there is no doubt that a statutory attempt (a la Prop. 71) to set a price (commonly known as price-fixing) will fail.
Wednesday, July 13, 2005
Coming Up
Later today we will have a report on Tuesday's meeting of the Oversight Committee, brought to you from a semi-remote anchorage in the Sea of Cortez in Mexico.
Correction
On July 8, we reported about a contract that Red Gate Communications had with CIRM. Red Gate resigned from the contract and was not terminated by CIRM.
Friday, July 08, 2005
CIRM's Million Dollar Outside Contracts
Legal and public relations advice, legislative lobbying and grant procedures – all are part of the $1.6 million mix of outside contracts that the California stem cell agency has quietly let since the beginning of the year.
It is not surprising that the agency has gone to the private sector, and it is likely to do more of it in the future. The fledgling bureaucracy is limited to only 50 employees by law.
Use of private consultants and service has some virtue. Properly done, it is a way to handle start-up and special costs without creating a large bureaucracy that is hard to change as needs change. At the same time, use of private consultants, some of whom have access to sensitive information, raises issues about potential conflicts. None of the consultants seem to be required to meet the same conflict-of-interest standards as CIRM's own employees.
That means CIRM must exercise careful oversight of the consultants, which requires a critical eye that may not fit with the startup team ethos of the new agency. The handling of the contracts also may provide some insight into how the agency is likely to proceed in the future as it hands out hundreds of millions of dollars in research grants.
The contracts have triggered some criticism from Oversight Committee members, who have complained about learning about them in the media(see "Murky Money" on June 14). And only one of the contracts (the executive search agreement) seems to have been let in what might be considered a normal competitive process.
Reporter Laura Mecoy of The Sacramento Bee was the first to disclose the total value of contracts. We have written about the $10,000-a-month lobbyist (May 5) and the now terminated contract with Red Gate Communications for public relations work("Hello to Edelman" April 22). Mecoy noted that her total did not include a figure for the Edelman PR contract, which the agency said was still under negotiation. One source indicated to us that it could be in the neighborhood of $700,000 annually, which would presumably include building a community education program from scratch.
Here is a look at some of the other contracts:
$350,000 one-year contract with the state controller's office for various support services for 2005, ranging from personnel to setting up computer networks.
$320,000 seven-month contract with the law firm of Remcho, Johansen and Purcell of San Leandro CA to act as general counsel with rates up to $300 an hour, plus expenses. The total on this contract was raised from an original $100,000.
$165,000 contract, plus expenses, for the Spencer Stuart search for a CIRM president and assistance with a search for a chief scientific officer. The contract was scheduled to end by May 31. The firm could be in for a substantial bonus if CIRM hires other persons turned up in the CEO search for non-CEO positions.
$70,000 six-month contract with Constance Atwell of Pinehurst NC to provide advice concerning development of policies and procedures for grant management. Atwell's contract has an interesting "trust me" provision regarding possible conflicts of interest. The contract states that Atwood "affirms that to the best of (her) knowledge there exists no actual or potential conflict between the consultant's family, business or financial interest and the services provided under this agreement...." Atwell is a retired grants manager from NIH.
It is not surprising that the agency has gone to the private sector, and it is likely to do more of it in the future. The fledgling bureaucracy is limited to only 50 employees by law.
Use of private consultants and service has some virtue. Properly done, it is a way to handle start-up and special costs without creating a large bureaucracy that is hard to change as needs change. At the same time, use of private consultants, some of whom have access to sensitive information, raises issues about potential conflicts. None of the consultants seem to be required to meet the same conflict-of-interest standards as CIRM's own employees.
That means CIRM must exercise careful oversight of the consultants, which requires a critical eye that may not fit with the startup team ethos of the new agency. The handling of the contracts also may provide some insight into how the agency is likely to proceed in the future as it hands out hundreds of millions of dollars in research grants.
The contracts have triggered some criticism from Oversight Committee members, who have complained about learning about them in the media(see "Murky Money" on June 14). And only one of the contracts (the executive search agreement) seems to have been let in what might be considered a normal competitive process.
Reporter Laura Mecoy of The Sacramento Bee was the first to disclose the total value of contracts. We have written about the $10,000-a-month lobbyist (May 5) and the now terminated contract with Red Gate Communications for public relations work("Hello to Edelman" April 22). Mecoy noted that her total did not include a figure for the Edelman PR contract, which the agency said was still under negotiation. One source indicated to us that it could be in the neighborhood of $700,000 annually, which would presumably include building a community education program from scratch.
Here is a look at some of the other contracts:
$350,000 one-year contract with the state controller's office for various support services for 2005, ranging from personnel to setting up computer networks.
$320,000 seven-month contract with the law firm of Remcho, Johansen and Purcell of San Leandro CA to act as general counsel with rates up to $300 an hour, plus expenses. The total on this contract was raised from an original $100,000.
$165,000 contract, plus expenses, for the Spencer Stuart search for a CIRM president and assistance with a search for a chief scientific officer. The contract was scheduled to end by May 31. The firm could be in for a substantial bonus if CIRM hires other persons turned up in the CEO search for non-CEO positions.
$70,000 six-month contract with Constance Atwell of Pinehurst NC to provide advice concerning development of policies and procedures for grant management. Atwell's contract has an interesting "trust me" provision regarding possible conflicts of interest. The contract states that Atwood "affirms that to the best of (her) knowledge there exists no actual or potential conflict between the consultant's family, business or financial interest and the services provided under this agreement...." Atwell is a retired grants manager from NIH.
Wednesday, June 29, 2005
Intermittent Reports: Wandering the Sea of Cortez
As all sailors must from time to time, we have hoisted anchor. This time to venture out into the Sea of Cortez for a number of weeks. Our new anchorages will be in remote desert locations where few people live and even land-based electricity is not to be had. That means reports will be be more intermittent on the California Stem Cell Report.
For those of you interested in such matters, we have been following the affairs of the California stem cell agency and posting reports via WiFi access here in romantic Old Mexico. Our WiFi link was from the cockpit of our sailboat, which was in a marina, to a a commercially provided antenna about ½ mile away. Cost of the service: About $18 US a month. Prior to that we used free WiFi service available in cantinas and restaurants in our location near Guaymas.
We are departing Guaymas to sail to the Baja California peninsula. We expect to use cellular data service (GPRS) to browse the Web and file reports. If that does not serve well, we will use an Internet cafe, which is much more cumbersome and slow, primarily because one must download the information, cart it off to the HQ of the California Stem Cell Report (a 39-foot Freedom cat-rigged ketch), digest the brew, write, retrace our steps to the Internet cafe and post the nuggets.
Meanwhile, if you see of items of interest, please alert me at djensen@californiastemcellreport.com or just by filing a comment by clicking on the word "comment," which follows this item. Thank you.
For those of you interested in such matters, we have been following the affairs of the California stem cell agency and posting reports via WiFi access here in romantic Old Mexico. Our WiFi link was from the cockpit of our sailboat, which was in a marina, to a a commercially provided antenna about ½ mile away. Cost of the service: About $18 US a month. Prior to that we used free WiFi service available in cantinas and restaurants in our location near Guaymas.
We are departing Guaymas to sail to the Baja California peninsula. We expect to use cellular data service (GPRS) to browse the Web and file reports. If that does not serve well, we will use an Internet cafe, which is much more cumbersome and slow, primarily because one must download the information, cart it off to the HQ of the California Stem Cell Report (a 39-foot Freedom cat-rigged ketch), digest the brew, write, retrace our steps to the Internet cafe and post the nuggets.
Meanwhile, if you see of items of interest, please alert me at djensen@californiastemcellreport.com or just by filing a comment by clicking on the word "comment," which follows this item. Thank you.
Thursday, June 23, 2005
Rebel Stem Cell Directors Not Happy with Klein
Dissident directors of the California stem cell agency took a crack at chairman Robert Klein, who barely fended off their move earlier this week.
The rebellion occurred at a little-noticed meeting Monday night of the agency's new legislative subcommittee and was reported exclusively this morning in a column by Stuart Leavenworth, associate editor of The Sacramento Bee and the only journalist attending the session.
The issue that triggered the flap was the chairmanship of the committee, according to Leavenworth.
"Although Klein convened the subcommittee assuming he would chair it, he quickly confronted an internal coup," Leavenworth reported.
Stem cell Oversight Committee member Joan Samuelson "bluntly suggested that Klein is becoming a political liability."
"'Bob has become a lightning rod and it is a difficult thing to deal with,' she said."
Another Oversight Committee member Jeff Sheehy said, "We are getting killed by the press. We are getting killed by the Legislature. We are getting killed by people who support us."
Leavenworth continued:
"The subcommittee has good reason to be angry. In recent months, Klein has hired lobbyists and public relations firms without consulting his fellow board members. A millionaire developer from the Bay Area, he has picked some of his personal aides to be institute employees. At one point he proposed an organizational chart that gave him his own exclusive staff, including the institute's legal counsel.
"All the while, Klein and the institute have treated all critics as enemies. Although embryonic stem cell research faces opposition from conservative Christians, some of the institute's most vocal critics have been groups such as Common Cause and Californians Aware, who do not oppose stem cell research but want the agency to operate more openly.
"There are also critics such the Pro-Choice Alliance Against Proposition 71, whose leaders fear the biomedical industry holds too much sway over this public body.
"After more than an hour of heated debate, the subcommittee deadlocked 5-5 on a motion that would effectively demote Klein as the institute's political leader.
"That's when Edward Penhoet, founder of Chiron Corp. and vice chair of the institute's oversight board, stepped in to give Klein a one-vote margin. Penhoet's participation was somewhat surprising, given that the institute, in its prior press release, didn't even list him as a legislative subcommittee member.
"In the end, Klein was saved not by his fellow patient advocates, but by a Southern California contingent of industrialists and academics who serve on the institute's oversight board. These included Tina Nova, CEO of a San Diego biomedical firm; Dr. John Reed, president of the La Jolla-based Burnham Institute; Susan Bryant, dean of biological sciences at UC Irvine; and Richard Murphy, president of the Salk Institute. (Murphy is also a director of the California Healthcare Institute, a biomedical industry group that has lobbyied against tougher conflict-of-interest rules for the stem cell program.)"
Separately, The Bee editorialized on the agency's new disclosure requirements.
"Sen. Deborah Ortiz, D-Sacramento, deserves credit for nudging California's institute in the right direction with her proposed constitutional amendment, SCA 13. Senate President Pro Tem Don Perata, bowing to pressure from Klein's allies, Sens. Joe Dunn and Jackie Speier, has now put that measure on hold. He shouldn't bury it, however," The Bee wrote.
"Within the stem cell institute, eminent doctors and patient advocates are staging a rebellion against Klein....If lawmakers keep the pressure on, the truly independent members of the institute's oversight committee may feel emboldened to go beyond Klein and his marginal policy enhancements. At that point, critics will no longer be tempted to describe the institute as a 'quasi-public agency.'"
Leavenworth's column demonstrated the value of diligent reporting (as in sitting through yet another tedious meeting). It will be interesting to see what other media do to play catch-up.
The rebellion occurred at a little-noticed meeting Monday night of the agency's new legislative subcommittee and was reported exclusively this morning in a column by Stuart Leavenworth, associate editor of The Sacramento Bee and the only journalist attending the session.
The issue that triggered the flap was the chairmanship of the committee, according to Leavenworth.
"Although Klein convened the subcommittee assuming he would chair it, he quickly confronted an internal coup," Leavenworth reported.
Stem cell Oversight Committee member Joan Samuelson "bluntly suggested that Klein is becoming a political liability."
"'Bob has become a lightning rod and it is a difficult thing to deal with,' she said."
Another Oversight Committee member Jeff Sheehy said, "We are getting killed by the press. We are getting killed by the Legislature. We are getting killed by people who support us."
Leavenworth continued:
"The subcommittee has good reason to be angry. In recent months, Klein has hired lobbyists and public relations firms without consulting his fellow board members. A millionaire developer from the Bay Area, he has picked some of his personal aides to be institute employees. At one point he proposed an organizational chart that gave him his own exclusive staff, including the institute's legal counsel.
"All the while, Klein and the institute have treated all critics as enemies. Although embryonic stem cell research faces opposition from conservative Christians, some of the institute's most vocal critics have been groups such as Common Cause and Californians Aware, who do not oppose stem cell research but want the agency to operate more openly.
"There are also critics such the Pro-Choice Alliance Against Proposition 71, whose leaders fear the biomedical industry holds too much sway over this public body.
"After more than an hour of heated debate, the subcommittee deadlocked 5-5 on a motion that would effectively demote Klein as the institute's political leader.
"That's when Edward Penhoet, founder of Chiron Corp. and vice chair of the institute's oversight board, stepped in to give Klein a one-vote margin. Penhoet's participation was somewhat surprising, given that the institute, in its prior press release, didn't even list him as a legislative subcommittee member.
"In the end, Klein was saved not by his fellow patient advocates, but by a Southern California contingent of industrialists and academics who serve on the institute's oversight board. These included Tina Nova, CEO of a San Diego biomedical firm; Dr. John Reed, president of the La Jolla-based Burnham Institute; Susan Bryant, dean of biological sciences at UC Irvine; and Richard Murphy, president of the Salk Institute. (Murphy is also a director of the California Healthcare Institute, a biomedical industry group that has lobbyied against tougher conflict-of-interest rules for the stem cell program.)"
Separately, The Bee editorialized on the agency's new disclosure requirements.
"Sen. Deborah Ortiz, D-Sacramento, deserves credit for nudging California's institute in the right direction with her proposed constitutional amendment, SCA 13. Senate President Pro Tem Don Perata, bowing to pressure from Klein's allies, Sens. Joe Dunn and Jackie Speier, has now put that measure on hold. He shouldn't bury it, however," The Bee wrote.
"Within the stem cell institute, eminent doctors and patient advocates are staging a rebellion against Klein....If lawmakers keep the pressure on, the truly independent members of the institute's oversight committee may feel emboldened to go beyond Klein and his marginal policy enhancements. At that point, critics will no longer be tempted to describe the institute as a 'quasi-public agency.'"
Leavenworth's column demonstrated the value of diligent reporting (as in sitting through yet another tedious meeting). It will be interesting to see what other media do to play catch-up.
Wednesday, June 22, 2005
Gurgling as Money and Brains Drain to the West
"The idea that if you throw money at it, people will come is true. Money talks." -- Zena Werb, a cell biologist at UCSF.
Just one quote from a fine overview of what California institutions are doing regarding the $3 billion stem cell bonanza in the Golden State.
Reporter Betsy Mason of the Contra Costa Times wrote:
"California's universities and research institutions are scrambling to position themselves for Prop. 71 funds. Nearly every institution in the state with its hands in the stem cell game or aspiring to join it is creating jobs for people experienced with the gifted little cells. Scientists are adamant that the healing potential of stem cells is real. But the stem cell field is itself in the embryonic stage and has very few senior scientists, perhaps just a couple of dozen, capable of heading a strong research group and training budding scientists. The draining sounds can already be heard gurgling through this small pool as California tries to satisfy its new appetite for the science.
"UCSF hopes to hire up to eight stem cell researchers in the next few years; Stanford is looking for five or six; UC Berkeley just hired one and is looking for at least one more; UCLA wants to fill its recently created stem cell institute with a dozen researchers; and UC San Diego hopes to bring on as many as 10.
"'Having a source of funds like this, which has suddenly come available to people only in the state of California, is a major benefit,' said Arnold Kriegstein, the director of UCSF's stem cell biology program. 'I get a lot of e-mail from people all over the world who are interested in coming to California.'
"The fierce competition within California for the top candidates will intensify as other states fight to keep their researchers. "The handful of people who are already doing this research can write their own ticket if they're good," said Randy Schekman, a stem cell researcher at UC Berkeley.
"Last month, Stanford managed to reel in two big catches, including Stefan Heller of Harvard. Heller was the first to identify adult stem cells in the inner ear of a mammal, and is at the top of his field."
Mason also quoted Mathew Lensch, an embryonic stem cell scientist at Harvard. "Now everybody asks if you're going to California. You want to talk about brain drain? The whole country's tilting to the west."
Just one quote from a fine overview of what California institutions are doing regarding the $3 billion stem cell bonanza in the Golden State.
Reporter Betsy Mason of the Contra Costa Times wrote:
"California's universities and research institutions are scrambling to position themselves for Prop. 71 funds. Nearly every institution in the state with its hands in the stem cell game or aspiring to join it is creating jobs for people experienced with the gifted little cells. Scientists are adamant that the healing potential of stem cells is real. But the stem cell field is itself in the embryonic stage and has very few senior scientists, perhaps just a couple of dozen, capable of heading a strong research group and training budding scientists. The draining sounds can already be heard gurgling through this small pool as California tries to satisfy its new appetite for the science.
"UCSF hopes to hire up to eight stem cell researchers in the next few years; Stanford is looking for five or six; UC Berkeley just hired one and is looking for at least one more; UCLA wants to fill its recently created stem cell institute with a dozen researchers; and UC San Diego hopes to bring on as many as 10.
"'Having a source of funds like this, which has suddenly come available to people only in the state of California, is a major benefit,' said Arnold Kriegstein, the director of UCSF's stem cell biology program. 'I get a lot of e-mail from people all over the world who are interested in coming to California.'
"The fierce competition within California for the top candidates will intensify as other states fight to keep their researchers. "The handful of people who are already doing this research can write their own ticket if they're good," said Randy Schekman, a stem cell researcher at UC Berkeley.
"Last month, Stanford managed to reel in two big catches, including Stefan Heller of Harvard. Heller was the first to identify adult stem cells in the inner ear of a mammal, and is at the top of his field."
Mason also quoted Mathew Lensch, an embryonic stem cell scientist at Harvard. "Now everybody asks if you're going to California. You want to talk about brain drain? The whole country's tilting to the west."
Stronger CIRM Standards Attract Little Notice
The California stem cell agency is moving forward with stronger conflict of interest standards in the wake of legislation that would have forced a ballot fight over even tougher standards.
A new legislative committee of the agency approved the new rules Monday night. And in an unusual move, the agency issued a midnight-hour press release announcing the action. The full Oversight Committee will consider the rules July 12 and is likely to approve a version of them.
The legislative committee's action has attracted little media notice, probably because it appeared to be a foregone conclusion. But the timing also discouraged coverage: an evening meeting that ran up against newspaper deadlines.
The standards approved by the committee had an interesting twist. To be changed, they would require a supermajority vote – 70 percent – of the Oversight Committee. That is the same vote requirement for a change of Proposition 71 itself by the legislature three years after passage – an irritating issue for some legislators.
According to CIRM's press release, the proposed standards would:
Require "divestment by ICOC members of financial investments in any business entity with more than 5% of its annual budget in stem cell therapies and in any business organization receiving a grant"
Broaden "conflict of interest provisions for working group members"
Provide "earlier public availability of full disclosure of working group funding recommendations"
Require "comprehensive reports to the State Legislature summarizing grant awards and recipients"
Ensure "increased public access to meetings of the Grants Working Group, the Standards Working Group and the Facilities Working group"
Provide "increased access to working group records"
The agency's press release also contained the following:
"'We are always striving to enhance our policies, and remain grateful for the support of Senators Perata, Ortiz, Speier, and Dunn,' said ICOC Chair Robert Klein. 'It is critical to public confidence in the CIRM that there be a clear understanding: we are building the finest standards for medicine, ethics, and competitive peer review in every aspect of the stem cell program. Our hope is that our collaboration with the public and the Legislature will create a model to serve as the standard for stem cell research in the nation.'
"Zach Hall, Ph.D, the Interim President of the CIRM, said a number of the standards that the subcommittee will recommend to the ICOC on July 12th in Irvine surpass the stringency of the National Institutes of Health and University of California standards."
A new legislative committee of the agency approved the new rules Monday night. And in an unusual move, the agency issued a midnight-hour press release announcing the action. The full Oversight Committee will consider the rules July 12 and is likely to approve a version of them.
The legislative committee's action has attracted little media notice, probably because it appeared to be a foregone conclusion. But the timing also discouraged coverage: an evening meeting that ran up against newspaper deadlines.
The standards approved by the committee had an interesting twist. To be changed, they would require a supermajority vote – 70 percent – of the Oversight Committee. That is the same vote requirement for a change of Proposition 71 itself by the legislature three years after passage – an irritating issue for some legislators.
According to CIRM's press release, the proposed standards would:
Require "divestment by ICOC members of financial investments in any business entity with more than 5% of its annual budget in stem cell therapies and in any business organization receiving a grant"
Broaden "conflict of interest provisions for working group members"
Provide "earlier public availability of full disclosure of working group funding recommendations"
Require "comprehensive reports to the State Legislature summarizing grant awards and recipients"
Ensure "increased public access to meetings of the Grants Working Group, the Standards Working Group and the Facilities Working group"
Provide "increased access to working group records"
The agency's press release also contained the following:
"'We are always striving to enhance our policies, and remain grateful for the support of Senators Perata, Ortiz, Speier, and Dunn,' said ICOC Chair Robert Klein. 'It is critical to public confidence in the CIRM that there be a clear understanding: we are building the finest standards for medicine, ethics, and competitive peer review in every aspect of the stem cell program. Our hope is that our collaboration with the public and the Legislature will create a model to serve as the standard for stem cell research in the nation.'
"Zach Hall, Ph.D, the Interim President of the CIRM, said a number of the standards that the subcommittee will recommend to the ICOC on July 12th in Irvine surpass the stringency of the National Institutes of Health and University of California standards."
Monday, June 20, 2005
New Jersey Lessons for California
While California is just embarking on a $3 billion stem cell research effort, New Jersey has already poured hundreds of millions of dollars into the biotech biz in its state. And it is considering pumping another $380 million into stem cell research.
New Jersey's efforts and its difficulties have some obvious implications for California. Reporter Clint Riley of the Record in New Jersey provided some perspective on the situation in the Garden in a couple of articles.
He reported on Sunday: "New Jersey's partnership with biotech is already running into problems. It is cloaked in secrecy and riddled with the potential for conflicts. Its goals are at times nebulous."
On Monday Riley wrote, "Secrecy is important to the biotech industry, in both its business and research incarnations. After all, this is a world where the sole ownership of ideas is the basis of profits. The picture is more complicated on the public side of the biotechnology partnership.
In particular, a closed-door culture poses significant challenges for those concerned about conflicts of interest."
His reports detail examples of where New Jersey's public interests and those of the private sector do not necessarily coincide. He also noted that New Jersey ponied up $500,000 for promotion at the 18,000-attendee BIO 2005 conference mentioned in the item below.
The articles make interesting reading for those following the affairs in California.
New Jersey's efforts and its difficulties have some obvious implications for California. Reporter Clint Riley of the Record in New Jersey provided some perspective on the situation in the Garden in a couple of articles.
He reported on Sunday: "New Jersey's partnership with biotech is already running into problems. It is cloaked in secrecy and riddled with the potential for conflicts. Its goals are at times nebulous."
On Monday Riley wrote, "Secrecy is important to the biotech industry, in both its business and research incarnations. After all, this is a world where the sole ownership of ideas is the basis of profits. The picture is more complicated on the public side of the biotechnology partnership.
In particular, a closed-door culture poses significant challenges for those concerned about conflicts of interest."
His reports detail examples of where New Jersey's public interests and those of the private sector do not necessarily coincide. He also noted that New Jersey ponied up $500,000 for promotion at the 18,000-attendee BIO 2005 conference mentioned in the item below.
The articles make interesting reading for those following the affairs in California.
California "Gold Rush" Discussions at Stem Cell Conferences
This a busy week for biotech conferences around the county, including two that will pay some special attention to California.
In San Francisco on Thursday, California stem cell chairman Robert Klein is scheduled to be the keynote speaker at the meeting of the International Society for Stem Cell Research at the Marriott Hotel.
The society reports that San Francisco, CIRM and various universities are "rolling out the red carpet" for 2,000 delegates. Cost for registration at the conference is $720 at this late date. Sponsorship of the session at which Klein is speaking cost $15,000.
Back east, a huge biotech industry conference, BIO 2005, is expected to attract 18,000 persons in Philadelphia. The program is much larger and California is relegated to lesser prominence.
A panel on Tuesday will discuss CIRM, including an appearance by a member of the stem cell agency's Oversight Committee, Edward Holmes, vice chancellor of Health Sciences and dean of the UC San Diego School of Medicine. Title of the panel is "The New Gold Rush?"
He will share the platform with Tom Okarma, Ph.D., M.D., President, CEO & Director, Geron Corp. and Bob Hariri, Ph.D., President, Celgene Cellular Therapeutics. Chairing the panel will be Alan Lewis, Ph.D., President, Celgene San Diego and Joe Panetta, President & CEO, BIOCOM.
Registration for the conference is now $1,995.
It is not likely that a member of the public can just drop by to take in one of these sessions involving California public employees. This is not unusual. Gubernatorial appearances as well as those involving other public officials generally have limits on who may attend. Nonetheless, such policies have always struck me as a bit of a departure from the idea that government should be close to the people.
In San Francisco on Thursday, California stem cell chairman Robert Klein is scheduled to be the keynote speaker at the meeting of the International Society for Stem Cell Research at the Marriott Hotel.
The society reports that San Francisco, CIRM and various universities are "rolling out the red carpet" for 2,000 delegates. Cost for registration at the conference is $720 at this late date. Sponsorship of the session at which Klein is speaking cost $15,000.
Back east, a huge biotech industry conference, BIO 2005, is expected to attract 18,000 persons in Philadelphia. The program is much larger and California is relegated to lesser prominence.
A panel on Tuesday will discuss CIRM, including an appearance by a member of the stem cell agency's Oversight Committee, Edward Holmes, vice chancellor of Health Sciences and dean of the UC San Diego School of Medicine. Title of the panel is "The New Gold Rush?"
He will share the platform with Tom Okarma, Ph.D., M.D., President, CEO & Director, Geron Corp. and Bob Hariri, Ph.D., President, Celgene Cellular Therapeutics. Chairing the panel will be Alan Lewis, Ph.D., President, Celgene San Diego and Joe Panetta, President & CEO, BIOCOM.
Registration for the conference is now $1,995.
It is not likely that a member of the public can just drop by to take in one of these sessions involving California public employees. This is not unusual. Gubernatorial appearances as well as those involving other public officials generally have limits on who may attend. Nonetheless, such policies have always struck me as a bit of a departure from the idea that government should be close to the people.
Friday, June 17, 2005
No Nasty Fall Election on Stem Cell Agency
Californians are not likely to get another chance this fall to vote on the California stem cell agency, which is a probably a good thing.
It would have been a nasty tussle, although there is a very slim chance that a ballot measure might emerge. As we noted in an item earlier this year, it would not have been in the best interests of the agency to have what basically amounts to a vote of confidence on CIRM.
This fall's election is likely to draw high participation from the right and far right, which would mean strong opposition to stem cell research. A ballot measure would have created a bully pulpit for foes of the program, and, regardless of the election outcome, the agency would have been savaged.
For now, the issues behind SCA13 will move forward in the form of a forthcoming letter to the agency expressing concerns of Democrats in the legislature.
News that the measure by Sen. Deborah Ortiz, D-Sacramento, has been put aside was broken by reporter Kevin Yamamura of The Sacramento Bee. The Associated Press did a brief version of the piece which then appeared on other newspaper web sites. But it appears that no other major California newspapers have matched Yamamura's story.
Instead of bringing SCA13 to a floor vote, he reported, "Democrats in the upper house...agreed to send a letter to the oversight committee insisting that the panel take action on its own by its July 12 meeting.
"Ortiz said lawmakers have agreed to pursue SCA13 if the oversight committee does not take action that resolves the Legislature's concerns. The letter being drafted would note that the Legislature could pursue SCA13 for the June 2006 ballot, though Ortiz still wants to leave open the possibility of putting the proposal before voters in November. She said she believes the Legislature has until August to put SCA 13 on the November ballot, if necessary.
"Ortiz had lined up support for SCA13 from the 15-member Senate Republican Caucus, but she needed at least 12 Democrats to sign on to the proposal to meet a two-thirds vote requirement.
"'There were a handful of (Democratic) members ready to support me on moving this off the floor," Ortiz said. 'But many others requested that we hold it, position it for June '06 and in the meantime send a fairly comprehensive letter outlining the policy concerns and acknowledging a desire by the Democratic caucus to move this forward in the future.'
"Senate President Pro Tem Don Perata, D-Oakland, said last week after a lengthy caucus meeting that Senate Democrats were in support of SCA 13, but he said there were strategic concerns about placing it on the November ballot.
"Ortiz described those concerns as 'mainly, how we can anticipate the messages that will be conveyed in the election and whether our resources, time and messaging should be prioritized to defeat initiatives problematic to Democrats.'"
Yamamura quoted stem cell chairman Robert Klein as saying, "We look forward to reviewing the letter and have benefitted greatly from the input of Sens. Perata, Ortiz, Dunn, Speier and their staffs, among others."
David Serrano Sewell, a member of the Oversight Committee and of the agency's legislative subcommittee, said he expects the stem cell panel to take some action on regulations by its July meeting. The legislative panel meets Monday to discuss changes in regulations.
Serrano Sewell said of Ortiz, "She has had a profound influence on the committee. We were going to make these changes, but if we have this (Ortiz proposal) out there, we're more motivated to do it. The issues she has raised are important."
However, the agency has record of strong opposition to Ortiz' issues, dating back to shortly after last fall's election. Technically it is possible later this summer for Ortiz to place a measure on the ballot should the agency be recalcitrant. But the position of the Democratic caucus is that they have more important political fish to fry in this fall's electoral battle with the governor.
It would have been a nasty tussle, although there is a very slim chance that a ballot measure might emerge. As we noted in an item earlier this year, it would not have been in the best interests of the agency to have what basically amounts to a vote of confidence on CIRM.
This fall's election is likely to draw high participation from the right and far right, which would mean strong opposition to stem cell research. A ballot measure would have created a bully pulpit for foes of the program, and, regardless of the election outcome, the agency would have been savaged.
For now, the issues behind SCA13 will move forward in the form of a forthcoming letter to the agency expressing concerns of Democrats in the legislature.
News that the measure by Sen. Deborah Ortiz, D-Sacramento, has been put aside was broken by reporter Kevin Yamamura of The Sacramento Bee. The Associated Press did a brief version of the piece which then appeared on other newspaper web sites. But it appears that no other major California newspapers have matched Yamamura's story.
Instead of bringing SCA13 to a floor vote, he reported, "Democrats in the upper house...agreed to send a letter to the oversight committee insisting that the panel take action on its own by its July 12 meeting.
"Ortiz said lawmakers have agreed to pursue SCA13 if the oversight committee does not take action that resolves the Legislature's concerns. The letter being drafted would note that the Legislature could pursue SCA13 for the June 2006 ballot, though Ortiz still wants to leave open the possibility of putting the proposal before voters in November. She said she believes the Legislature has until August to put SCA 13 on the November ballot, if necessary.
"Ortiz had lined up support for SCA13 from the 15-member Senate Republican Caucus, but she needed at least 12 Democrats to sign on to the proposal to meet a two-thirds vote requirement.
"'There were a handful of (Democratic) members ready to support me on moving this off the floor," Ortiz said. 'But many others requested that we hold it, position it for June '06 and in the meantime send a fairly comprehensive letter outlining the policy concerns and acknowledging a desire by the Democratic caucus to move this forward in the future.'
"Senate President Pro Tem Don Perata, D-Oakland, said last week after a lengthy caucus meeting that Senate Democrats were in support of SCA 13, but he said there were strategic concerns about placing it on the November ballot.
"Ortiz described those concerns as 'mainly, how we can anticipate the messages that will be conveyed in the election and whether our resources, time and messaging should be prioritized to defeat initiatives problematic to Democrats.'"
Yamamura quoted stem cell chairman Robert Klein as saying, "We look forward to reviewing the letter and have benefitted greatly from the input of Sens. Perata, Ortiz, Dunn, Speier and their staffs, among others."
David Serrano Sewell, a member of the Oversight Committee and of the agency's legislative subcommittee, said he expects the stem cell panel to take some action on regulations by its July meeting. The legislative panel meets Monday to discuss changes in regulations.
Serrano Sewell said of Ortiz, "She has had a profound influence on the committee. We were going to make these changes, but if we have this (Ortiz proposal) out there, we're more motivated to do it. The issues she has raised are important."
However, the agency has record of strong opposition to Ortiz' issues, dating back to shortly after last fall's election. Technically it is possible later this summer for Ortiz to place a measure on the ballot should the agency be recalcitrant. But the position of the Democratic caucus is that they have more important political fish to fry in this fall's electoral battle with the governor.
Thursday, June 16, 2005
Correction on Pomeroy Position
Based on incorrect information on the CIRM website, we erroneously described Claire Pomeroy's position at the UC Davis medical school in the item below. She is currently vice chancellor for human health sciences and dean of the UC Davis School of Medicine -- not executive associate dean.
Tuesday, June 14, 2005
Murky Money Matters, Disgruntled Directors
The burn rate at the California stem cell agency is about $300,000 a month and likely more. The agency already owes private businesses or other state agencies more than $300,000 after its first five months of life.
The spending is picayune compared to the $100s of millions the agency plans to lavish on stem cell research in California. But how the agency is handling information about its spending is triggering a bit of flap that touches on the credibility of a bureaucracy whose retort to critics is often "trust us."
Even directors of the agency are in the dark about how the agency spends its money, a fact that surfaced at the Oversight Committee earlier this month.
The exchange was not reported by the mainstream media which nearly always focuses on the current highest profile controversy.
According to a transcript of the meeting, the issue came up following discussion of the $5 million Dolby donation. Dr. Claire Pomeroy, executive associate dean of the UC Davis School of Medicine, then raised questions about the agency's budget as well as the $1 million in contracts it has authorized.
"If I was giving a donation of $5 million, I would probably want to see the budget of the organization to which I was donating. and I wonder what was told to them (the Dolbys) about our budget, and I wonder when we might as a board be seeing a budget," said Pomeroy, who has both an MBA and MD.
In response, Chairman Robert Klein referred to a "cash flow" budget that purportedly had given useful financial information. The only significant financial information in that document, however, was that the agency had a $3 million loan from the state that would be gone by November. It contained no breakdown on spending even in major categories.
Pomeroy then brought up the contracting issue. "It was somewhat disconcerting to have to learn from the newspaper(an article by reporter Laura Mecoy of The Sacramento Bee) that we have, in fact, given out over a million dollars in consulting contracts that I personally wasn't aware of and don't feel like I'd been informed about. Hopefully we'll be able to know about those."
Klein replied, "Doctor, we have not given out a million dollars in consulting contracts. The question is if we, as I believe, what the figures are, is if all of the legal fees with litigation were spent and all of the going through the end of the year, they extended out contracts through the end of the year that are not in existence yet, and are going to be brought to this board, for example, on the media public education contract is under review right now, is on a month-to-month basis, and will come to this board actually for review. So I learned from the article that there were some projections that, in fact, assume expenditures that, in fact, are not fully committed expenditures."
"That's good to hear," Pomeroy said. "And then when we get the data, we'll be able to respond when those kind of statements are made. It would be good to have that."
Klein said, "Yes. And I will hope that our governance committee will undertake that as one of their first objectives."
At least one other director indicated some unhappiness with budgetary information. And it is fair to say that they likely reflected unexpressed sentiments of some others on the 29-member board.
The spending is picayune compared to the $100s of millions the agency plans to lavish on stem cell research in California. But how the agency is handling information about its spending is triggering a bit of flap that touches on the credibility of a bureaucracy whose retort to critics is often "trust us."
Even directors of the agency are in the dark about how the agency spends its money, a fact that surfaced at the Oversight Committee earlier this month.
The exchange was not reported by the mainstream media which nearly always focuses on the current highest profile controversy.
According to a transcript of the meeting, the issue came up following discussion of the $5 million Dolby donation. Dr. Claire Pomeroy, executive associate dean of the UC Davis School of Medicine, then raised questions about the agency's budget as well as the $1 million in contracts it has authorized.
"If I was giving a donation of $5 million, I would probably want to see the budget of the organization to which I was donating. and I wonder what was told to them (the Dolbys) about our budget, and I wonder when we might as a board be seeing a budget," said Pomeroy, who has both an MBA and MD.
In response, Chairman Robert Klein referred to a "cash flow" budget that purportedly had given useful financial information. The only significant financial information in that document, however, was that the agency had a $3 million loan from the state that would be gone by November. It contained no breakdown on spending even in major categories.
Pomeroy then brought up the contracting issue. "It was somewhat disconcerting to have to learn from the newspaper(an article by reporter Laura Mecoy of The Sacramento Bee) that we have, in fact, given out over a million dollars in consulting contracts that I personally wasn't aware of and don't feel like I'd been informed about. Hopefully we'll be able to know about those."
Klein replied, "Doctor, we have not given out a million dollars in consulting contracts. The question is if we, as I believe, what the figures are, is if all of the legal fees with litigation were spent and all of the going through the end of the year, they extended out contracts through the end of the year that are not in existence yet, and are going to be brought to this board, for example, on the media public education contract is under review right now, is on a month-to-month basis, and will come to this board actually for review. So I learned from the article that there were some projections that, in fact, assume expenditures that, in fact, are not fully committed expenditures."
"That's good to hear," Pomeroy said. "And then when we get the data, we'll be able to respond when those kind of statements are made. It would be good to have that."
Klein said, "Yes. And I will hope that our governance committee will undertake that as one of their first objectives."
At least one other director indicated some unhappiness with budgetary information. And it is fair to say that they likely reflected unexpressed sentiments of some others on the 29-member board.
Upcoming: More on the Stem Cell Agency's Budget
We expect to have more information on the California stem cell agency's recondite budget dealings in a posting Wednesday.
Stem Cell Stakeholders Need the Financial Skinny
Californians know little about the budget or the spending of the California stem cell agency.
Officials have reported that money will run out in November unless more money is forthcoming. That was before the $5 million Dolby donation, which is presumably on its way.
Some details of spending by the agency have been published on this blog, including information about public relations programs and lobbying. Today reporter Laura Mecoy reported that "records requested by The (Sacramento) Bee that show (the agency) has contracted to spend up to $561,000 more than the $1.1 million previously reported for outside consultants and lawyers.
"The newly released records also show that the institute has $302,227 in debts or payments it has delayed to other state agencies, its law firm and others until it could get additional financing."
None of this is surprising. But given the public responsibilities of the agency and its pledge of openness and accountability, it is surprising that we have not seen a budget or least some sort of recap of spending from the agency. We understand that at least one Oversight Committee member is irritated at that failure.
It is also simply good government and good business to give the stakeholders the financial facts.
Officials have reported that money will run out in November unless more money is forthcoming. That was before the $5 million Dolby donation, which is presumably on its way.
Some details of spending by the agency have been published on this blog, including information about public relations programs and lobbying. Today reporter Laura Mecoy reported that "records requested by The (Sacramento) Bee that show (the agency) has contracted to spend up to $561,000 more than the $1.1 million previously reported for outside consultants and lawyers.
"The newly released records also show that the institute has $302,227 in debts or payments it has delayed to other state agencies, its law firm and others until it could get additional financing."
None of this is surprising. But given the public responsibilities of the agency and its pledge of openness and accountability, it is surprising that we have not seen a budget or least some sort of recap of spending from the agency. We understand that at least one Oversight Committee member is irritated at that failure.
It is also simply good government and good business to give the stakeholders the financial facts.
Monday, June 13, 2005
Bustamante Opposes SCA13
The Sacramento Bee carried a brief item on the lieutenant governor and SCA13. Here is the full text:
"In a last-minute lobbying effort, Lt. Gov. Cruz Bustamante sent a letter last week to senators urging them to block Sen. Deborah Ortiz's plan to impose new restrictions on the state's stem cell agency.
Bustamante has long backed the agency and had a close relationship with stem cell committee Chairman Robert Klein II, who adamantly opposes Ortiz's proposal. Klein gave $52,400 to Bustamante's campaign account in 2003.
"'Klein didn't ask him to write the letter," said Bustamante spokesman Stephen Green. "It's an issue (Bustamante) feels very strongly about.'"
Currently there is one vacancy on the stem cell agency's Oversight Committee, which Bustamante is due to fill soon with an appointee.
"In a last-minute lobbying effort, Lt. Gov. Cruz Bustamante sent a letter last week to senators urging them to block Sen. Deborah Ortiz's plan to impose new restrictions on the state's stem cell agency.
Bustamante has long backed the agency and had a close relationship with stem cell committee Chairman Robert Klein II, who adamantly opposes Ortiz's proposal. Klein gave $52,400 to Bustamante's campaign account in 2003.
"'Klein didn't ask him to write the letter," said Bustamante spokesman Stephen Green. "It's an issue (Bustamante) feels very strongly about.'"
Currently there is one vacancy on the stem cell agency's Oversight Committee, which Bustamante is due to fill soon with an appointee.
World Map Link Repaired
Thanks to the alert reader who told us about the bad link on the world stem cell map. It has been fixed.
Sunday, June 12, 2005
More on Reality: Summoning Up the Troops
The blog.bioethics.net is warning of the peril posed by "over-eager salesmen" of stem cell cures, citing an article by a California researcher as opening the door for critics.
Written by the editors of the American Journal of Bioethics, the blog said:
"Today, dozens of children and others who argue - like us - for stem cell research are held up as potential recipients of embryonic stem cell-derived therapy, as though the big worry is that they will not receive their embryo pills next year and will suffer as a result. You don't have to have a long memory to see how dangerous these views can be. Just think back to gene therapy, and the clamor of folks to enroll in early, non-therapeutic trials because of the perceived magic of anything genetic. The very idea of 'gene therapy research' is an oxymoron, if you think about it, as was argued by Nancy King and others.
"Well, in California the arguments in favor of stem cell research are often a big more, um, dramatic than other places, and as a consequence the infractions of the 'do not promise therapies to subjects who will not be getting them yet' rule are more problematic. And it doesn't get worse than this one, by A Scientist In Irvine (Peter J. Bryant), who writes the San Francisco Chronicle to let us know that among the victims of unenlightened stem cell research are the soldiers in Iraq, who won't get their stem cell therapies and will die as a result. It isn't that the argument is wrong, and it certainly isn't that the argument isn't creative, it's that the argument is premature - and in some ways the point to make about stem cell research is that it will transform medicine entirely, including producing therapies that one day will not require the use of embryos, therapies that could never have been produced without the use of this research. Yes that will one day help soldiers. But the promulgation of this 'get it now or else' thing just makes it easier for the opponents of stem cell research to paint stem cell researchers as over-eager salesmen of therapeutic misconception."
For more on this subject, see the "reality check" item below.
Written by the editors of the American Journal of Bioethics, the blog said:
"Today, dozens of children and others who argue - like us - for stem cell research are held up as potential recipients of embryonic stem cell-derived therapy, as though the big worry is that they will not receive their embryo pills next year and will suffer as a result. You don't have to have a long memory to see how dangerous these views can be. Just think back to gene therapy, and the clamor of folks to enroll in early, non-therapeutic trials because of the perceived magic of anything genetic. The very idea of 'gene therapy research' is an oxymoron, if you think about it, as was argued by Nancy King and others.
"Well, in California the arguments in favor of stem cell research are often a big more, um, dramatic than other places, and as a consequence the infractions of the 'do not promise therapies to subjects who will not be getting them yet' rule are more problematic. And it doesn't get worse than this one, by A Scientist In Irvine (Peter J. Bryant), who writes the San Francisco Chronicle to let us know that among the victims of unenlightened stem cell research are the soldiers in Iraq, who won't get their stem cell therapies and will die as a result. It isn't that the argument is wrong, and it certainly isn't that the argument isn't creative, it's that the argument is premature - and in some ways the point to make about stem cell research is that it will transform medicine entirely, including producing therapies that one day will not require the use of embryos, therapies that could never have been produced without the use of this research. Yes that will one day help soldiers. But the promulgation of this 'get it now or else' thing just makes it easier for the opponents of stem cell research to paint stem cell researchers as over-eager salesmen of therapeutic misconception."
For more on this subject, see the "reality check" item below.
Check Out World Stem Cell Map
We have added some new links to this blog and restored some of the old ones that were lost when we reformatted. The links are annotated as well. A couple of nifty ones are the maps of stem cell research and the world stem cell map. If you have suggestions for additional links, please send them djensen@californiastemcellreport.com or just click on "comment" below.
Saturday, June 11, 2005
Reality Check on a "Recipe for Trouble"
A Harvard stem cell researcher has weighed in with a reminder about the tedious nature of scientific research, especially regarding stem cells.
It stands in contrast to the contentions of officials from the California stem cell agency that their enterprise is a life-and-death matter. Certainly it is important to get on with stem cell research. But the time line on development of stem cell therapies is years, perhaps decades. And then there is the old saw about slowing down so you can go faster.
This is not to demean or diminish the needs of those living with diseases that may be alleviated with stem cell therapy.
David A. Shaywitz, an endocrinologist and stem-cell researcher at Harvard University, wrote in an article that appeared in the Washington Post and the San Francisco Chronicle:
"Advocacy groups must ...level with their stakeholders and explain why treatments based on stem cells will take such a long time to materialize."
He added, "At the same time, these organizations must continue to push scientists to work harder and achieve results faster, encouraging investigators to keep in mind the patients in whose name the research is being conducted (and funded)."
Shaywitz addressed California specifically:
"The explicit expectation of rapid clinical progress -- a key component of California's stem-cell initiative, for example -- is a recipe for trouble. If embryonic stem cells are rushed into clinical trials before the solid science has been done, the resulting fiasco could easily doom the entire future of the field."
"The truth is that science -- good science -- can be maddeningly slow," the stem cell researcher said.
It stands in contrast to the contentions of officials from the California stem cell agency that their enterprise is a life-and-death matter. Certainly it is important to get on with stem cell research. But the time line on development of stem cell therapies is years, perhaps decades. And then there is the old saw about slowing down so you can go faster.
This is not to demean or diminish the needs of those living with diseases that may be alleviated with stem cell therapy.
David A. Shaywitz, an endocrinologist and stem-cell researcher at Harvard University, wrote in an article that appeared in the Washington Post and the San Francisco Chronicle:
"Advocacy groups must ...level with their stakeholders and explain why treatments based on stem cells will take such a long time to materialize."
He added, "At the same time, these organizations must continue to push scientists to work harder and achieve results faster, encouraging investigators to keep in mind the patients in whose name the research is being conducted (and funded)."
Shaywitz addressed California specifically:
"The explicit expectation of rapid clinical progress -- a key component of California's stem-cell initiative, for example -- is a recipe for trouble. If embryonic stem cells are rushed into clinical trials before the solid science has been done, the resulting fiasco could easily doom the entire future of the field."
"The truth is that science -- good science -- can be maddeningly slow," the stem cell researcher said.
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