One of the members of the Citizens Financial Accountability Oversight Committee for the California stem cell agency, which meets today for the first time, is not qualified and was appointed as a "political payoff," a watchdog group said today.
The Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., said in a press release that the appointment of John Hein by Democratic Assembly Speaker Fabian Nunez "smacks of cronyism and the pay-to-play culture that dominates California politics."
John M. Simpson, stem cell project director for the foundation, noted that Prop. 71 requires members of the oversight committee to have "medical backgrounds and knowledge of relevant financial matters."
Hein was a longtime lobbyist for the California Teachers Association and now heads the political and policy consulting firm of HC&A of Sacramento, Ca. Hein was also a key negotiator in the education deal with Gov. Schwarzenegger that collapsed a few years back.
Calling on Hein to resign, Simpson said the CTA, a politically influential union in California, has been a longtime backer of the Nunez and contributed $12,800 to Nunez in election cycle preceding Hein's appointment.
Thursday, September 14, 2006
Wednesday, September 13, 2006
Wanted: Fresh Human Eggs
What is the going price for human eggs these days? It runs as much as $50,000. But there are still not enough eggs to fuel the stem cell research machine, according to two articles in the Los Angeles Times today.
Reporter Karen Kaplan wrote:
Romney discussed the issue of possible exploitation of women egg donors, particularly low income, minority women. She also quoted Radhika Rao, of UC Hastings College of the Law in San Francisco and a member of a state commission that crafted guidelines for stem cell research, as saying,
Reporter Karen Kaplan wrote:
"While the world debates the morality of stem cell research, scientists are grappling with a more basic issue — a shortage of eggs that they say is crippling their work."One example that Kaplan reported involved Advanced Cell Technology of Alameda, Ca. The company has used newspaper ads to recruit women, some of whom declined after learning they would not be compensated beyond expenses. Kaplan wrote:
"After 10 months, one woman has passed the physical and mental health exams. She was scheduled to begin the egg retrieval regimen last week and could have eight eggs ready to harvest in early October."Reporter Lee Romney examined the California scene including legislation (SB1260) by Sen. Deborah Ortiz, D-Sacramento, and the California stem cell agency.
Romney discussed the issue of possible exploitation of women egg donors, particularly low income, minority women. She also quoted Radhika Rao, of UC Hastings College of the Law in San Francisco and a member of a state commission that crafted guidelines for stem cell research, as saying,
"If you pay women a lot and they're white, it isn't exploitation?"
Tuesday, September 12, 2006
The Unexpectedly (to some) Long Life of CIRM
When is a 10-year embryonic stem cell research program not a 10-year embryonic stem cell research program?
Answer: When it is the California Institute for Regenerative Medicine.
Confused? We were too. We have been operating under the mistaken impression that the California stem cell agency has a 10-year life span that began when voters created it in 2004. In fact, CIRM has life in virtual perpetuity. And it can fund itself with the state's general obligation bonds apparently until it hits the $3 billion cap. All of which raise some interesting questions about life after $3 billion.
Two years ago when Prop. 71 was approved, news accounts repeatedly referred to a 10-year period in connection with the agency. Sometimes the time span was linked with the ability to issue bonds. Sometimes not. But regardless of context, 10 years kept popping up. Even the economic report by the Analysis Group, which was paid for by the Prop. 71 campaign, referred to funding over 10 years. And today the web site of the Alliance for Stem Cell Research, a spin off from the campaign organization, uses the 10-year term. The ballot measure itself says the intent of the measure was to authorize funding over a 10-year period. However, the analysis of the initiative by the state's legislative analyst is clearer. It says:
That prompted a response from Dale Carlson, chief communications officer for CIRM, who asked for a correction. He acknowledged that he too was once under the misapprehension that CIRM would pass on at age 10. He said,
Given the nature of organizations and bureaucracies, it is not likely that CIRM will want to close its doors after the $3 billion runs out. It will be an organism that will want to survive, and there may well be good reasons for its life to continue. The state could fund it through the budget process, but without the usual oversight it gives other state agencies, which do not have the constitutional independence that CIRM does. It could also turn to private fundraising, as it has done so already to the tune of $50 million. California's biotech industry may find it useful to provide hundreds of millions of dollars to CIRM to continue pursuing work that is basic to the well-being of the business. Of course, some folks might object to a state agency behaving in such a fashion. But CIRM is virtually immune to control by the governor or the legislature.
And then there is a provision within Prop. 71 that provides for use of "alternate financial plans" instead of state bonds if they would significantly lower borrowing costs.
Is there a lesson in all this? Just the usual. Never assume. Expect the unexpected. Re-read the rules and instructions. However, there may be some folks who will not be happy to find that CIRM has perpetual life.
Answer: When it is the California Institute for Regenerative Medicine.
Confused? We were too. We have been operating under the mistaken impression that the California stem cell agency has a 10-year life span that began when voters created it in 2004. In fact, CIRM has life in virtual perpetuity. And it can fund itself with the state's general obligation bonds apparently until it hits the $3 billion cap. All of which raise some interesting questions about life after $3 billion.
Two years ago when Prop. 71 was approved, news accounts repeatedly referred to a 10-year period in connection with the agency. Sometimes the time span was linked with the ability to issue bonds. Sometimes not. But regardless of context, 10 years kept popping up. Even the economic report by the Analysis Group, which was paid for by the Prop. 71 campaign, referred to funding over 10 years. And today the web site of the Alliance for Stem Cell Research, a spin off from the campaign organization, uses the 10-year term. The ballot measure itself says the intent of the measure was to authorize funding over a 10-year period. However, the analysis of the initiative by the state's legislative analyst is clearer. It says:
"The measure states its intent, but does not require in statute, that the bonds be sold during a ten-year period."The longevity of CIRM came up when we wrote an item that said only 60 percent of the agency's life span remained.
That prompted a response from Dale Carlson, chief communications officer for CIRM, who asked for a correction. He acknowledged that he too was once under the misapprehension that CIRM would pass on at age 10. He said,
"I seem to have inherited a common misconception that CIRM is authorized to exist for only 10 years. I assume that stems from language in Prop. 71 regarding the issuance of an average of $295 million in bonds over 10 years, or it may be a legacy from the campaign. Whatever the case, there is in fact no timeline or deadline or sunset provision in Prop. 71.As we remarked earlier, all of this raises interesting questions about life after $3 billion, a date that may not occur until about 2017 or perhaps several years later.
"We are authorized to issue up to $350 million in bonds in a single year. Anything short of that can be rolled over to subsequent years. We don’t expect the funding to remain constant year over year. Instead, we expect to set each year’s amount based on the state of our strategic plans, the current research environment, scientific advances, newly recognized needs and opportunities, etc. It will be a dynamic process. Many (if not most) of the grants we award are likely to extend out over several years.
"The litigation has an effect, of course. It delays the issuance of authorized public general obligation bonds. It does not mean, however, that we’ll be issuing more than $350 million in a single year to 'catch up', nor that our effective half-life is shortened. The litigation is likely to extend the CIRM’s life and funding program, to make up for the delayed issuance of GO bonds."
Given the nature of organizations and bureaucracies, it is not likely that CIRM will want to close its doors after the $3 billion runs out. It will be an organism that will want to survive, and there may well be good reasons for its life to continue. The state could fund it through the budget process, but without the usual oversight it gives other state agencies, which do not have the constitutional independence that CIRM does. It could also turn to private fundraising, as it has done so already to the tune of $50 million. California's biotech industry may find it useful to provide hundreds of millions of dollars to CIRM to continue pursuing work that is basic to the well-being of the business. Of course, some folks might object to a state agency behaving in such a fashion. But CIRM is virtually immune to control by the governor or the legislature.
And then there is a provision within Prop. 71 that provides for use of "alternate financial plans" instead of state bonds if they would significantly lower borrowing costs.
Is there a lesson in all this? Just the usual. Never assume. Expect the unexpected. Re-read the rules and instructions. However, there may be some folks who will not be happy to find that CIRM has perpetual life.
Monday, September 11, 2006
Update on Legal Actions Against CIRM
Someone queried us the other day concerning the effort by the losers in California stem cell trial to overturn the verdict that favored CIRM. "What is going on?" was the question.
The answer: Not much.
As of Friday, the losers had failed to file their brief with the appellate court. Once that happens, presumably later this month, CIRM will file its response. Then the losers will get a chance to rebut.
In an interview today with the California Stem Cell Report, Tamar Pachter, the deputy attorney general handling the case for CIRM, noted, however, that the appeal is on an expedited calendar so the matter should move more quickly than normal appeals.
She also said that another action, originally filed in the Sacramento by the opponents of the agency, has been modified substantially. Originally the action sought to block CIRM training grants to the University of California on the grounds that they violated state law. That argument has been altered to contend that the grants violate only Prop. 71. Pachter said she expects that such arguments are likely to become commonplace as CIRM issues more grants.
The answer: Not much.
As of Friday, the losers had failed to file their brief with the appellate court. Once that happens, presumably later this month, CIRM will file its response. Then the losers will get a chance to rebut.
In an interview today with the California Stem Cell Report, Tamar Pachter, the deputy attorney general handling the case for CIRM, noted, however, that the appeal is on an expedited calendar so the matter should move more quickly than normal appeals.
She also said that another action, originally filed in the Sacramento by the opponents of the agency, has been modified substantially. Originally the action sought to block CIRM training grants to the University of California on the grounds that they violated state law. That argument has been altered to contend that the grants violate only Prop. 71. Pachter said she expects that such arguments are likely to become commonplace as CIRM issues more grants.
Another Reason for Public Disclosure by CIRM Grant Reviewers
The California stem cell agency says that the scientists who make "recommendations" regarding who receives hundreds of millions of dollars in grants do not need to disclose publicly their financial interests.
On Sunday, however, the Los Angeles Times carried a piece that demonstrates again why public disclosure is needed.
Reporter David Willman wrote.:
The Walsh story is not isolated. Conflicts of interests are widely reported in medical research and are probably impossible to avoid. All the more reason to bring the financial interests at play out into the sunshine.
As for the use of quotation marks around the word recommendation in the first paragraph of this item, the reviewers do make recommendations on the grants but those are virtually de facto decisions, a position that we acknowledge CIRM disagrees with.
On Sunday, however, the Los Angeles Times carried a piece that demonstrates again why public disclosure is needed.
Reporter David Willman wrote.:
In this case Walsh allegedly failed to disclose to NIH. One has to ask the question: Would public disclosure have prevented the alleged misconduct? That is impossible to tell, but it would have raised the importance of the issue to a higher level and added a deterrent component. It would have also led to critical oversight from various public watchdog groups that love to forage in public documents. With public disclosure presumably it would have taken less than five years for the alleged misdeeds to surface. (Five years, by the way, is about 60 percent of CIRM's remaining life.)"A senior researcher at the National Institutes of Health engaged in 'serious misconduct' by entering into dozens of unauthorized private arrangements with drug companies and failing to report annually the outside income, totaling more than $100,000, a confidential internal review by the agency has found.
"Officials at the NIH concluded late last year that the actions of Dr. Thomas J. Walsh, who has helped lead major clinical trials involving cancer patients, might result in dismissal from federal government service. No disciplinary action has been taken.
"The internal review, conducted by lawyers and other ethics specialists within the office of the NIH director, found that from 1999 to 2004, Walsh received fees totaling $100,970 from pharmaceutical and biotechnology companies. He accepted fees from 25 companies and has led government-sponsored research involving some of those companies' drugs."
The Walsh story is not isolated. Conflicts of interests are widely reported in medical research and are probably impossible to avoid. All the more reason to bring the financial interests at play out into the sunshine.
As for the use of quotation marks around the word recommendation in the first paragraph of this item, the reviewers do make recommendations on the grants but those are virtually de facto decisions, a position that we acknowledge CIRM disagrees with.
Stem Cell Snippets: Starters to Strategic Planning
Links to interesting pieces and announcements involving California stem cell issues.
Stem Cell 'Starter' – The tale of Jennifer Cash, a UC Davis grad student and a worker well down the stem cell food chain. She is trying to concoct a stem cell 'starter' medium, according to a writer Sam Whiting in the San Francisco Chronicle.
Cautionary Piece – An Australian web site has a summary of an article that is called a "cautionary tale" about the California stem cell agency. The original article, by Tamra Lysaght of the University of Sydney, was published in the Journal of Bioethical Inquiry but is not yet available online.
CIRM Strategic Meeting – On Friday, CIRM will hold a meeting in San Francisco of its Strategic Planning Advisory Committee. The agenda includes a report on the Aug. 26 Diversity Focus Group Meeting and a progress report on the strategic plan.
Stem Cell 'Starter' – The tale of Jennifer Cash, a UC Davis grad student and a worker well down the stem cell food chain. She is trying to concoct a stem cell 'starter' medium, according to a writer Sam Whiting in the San Francisco Chronicle.
Cautionary Piece – An Australian web site has a summary of an article that is called a "cautionary tale" about the California stem cell agency. The original article, by Tamra Lysaght of the University of Sydney, was published in the Journal of Bioethical Inquiry but is not yet available online.
CIRM Strategic Meeting – On Friday, CIRM will hold a meeting in San Francisco of its Strategic Planning Advisory Committee. The agenda includes a report on the Aug. 26 Diversity Focus Group Meeting and a progress report on the strategic plan.
Thursday, September 07, 2006
No Time to Weaken 'Second Level of Oversight'
Should the public officials who monitor the financial practices of the $3 billion California stem cell agency have to disclose their financial interests as state law requires?
In a word, yes.
And it is surprising that consideration of seeking an exemption from financial disclosure is even on the board's agenda for its first meeting.
State regulations permit exemptions from disclosure only if the state entity is powerless (has no decision-making authority), has few funds (budget less than $150,000) and will own no real estate. Nominally the Citizens Financial Accountability Oversight Committee seems to meet that criteria. It can only review and make recommendations to CIRM.
That said, CIRM Chairman Robert Klein has cited the importance of the committee. He has called it "an extraordinary response" and "an unprecedented second level of oversight." Klein made his remarks at the March 1, 2005, meeting of the CIRM Oversight Committee.
State Controller Steve Westly, chair of the financial accountability group, was at the same meeting to caution the stem cell agency to mind its financial Ps and Qs. He said CIRM amounted to a kind of "public covenant" with the public making the investment and taking the risk. Westly said:
One watchdog group, the Foundation for Taxpaper and Consumers Rights, has written to state Controller Steve Westly objecting to any exemption.
John M. Simpson, stem cell project director for the foundation, said:
These are extraordinarily capable people who bring valuable experience and insight to CIRM's operations. They also bring a web of financial and business ties that may or may not constitute conflicts of interest as they critique CIRM's financial practices and performance. For example, it is not hard to imagine that an enterprise favored by one of the financial committeee members could find a more friendly reception at CIRM than your average proposal.
We understand the burden that disclosure places on folks such as Siegal and Potter. They may even resign from the committee rather than make a public disclosure. But openness and transparency concerning the public's multibillion dollar investment should come first.
In a word, yes.
And it is surprising that consideration of seeking an exemption from financial disclosure is even on the board's agenda for its first meeting.
State regulations permit exemptions from disclosure only if the state entity is powerless (has no decision-making authority), has few funds (budget less than $150,000) and will own no real estate. Nominally the Citizens Financial Accountability Oversight Committee seems to meet that criteria. It can only review and make recommendations to CIRM.
That said, CIRM Chairman Robert Klein has cited the importance of the committee. He has called it "an extraordinary response" and "an unprecedented second level of oversight." Klein made his remarks at the March 1, 2005, meeting of the CIRM Oversight Committee.
State Controller Steve Westly, chair of the financial accountability group, was at the same meeting to caution the stem cell agency to mind its financial Ps and Qs. He said CIRM amounted to a kind of "public covenant" with the public making the investment and taking the risk. Westly said:
"Bob's exactly right. These are large numbers. The public wants to know there's every level of scrutiny."As to the financial accountability committee, Westly said:
"It's a double blind check. We want to make sure we get it right for the public."The committee was also cited by the state Department of Justice in its so far successful legal defense of the agency against those who seek to kill it off. In legal filings, the Justice Department mentioned the committee as one of the methods by which the state "generally exercises management and control of state institutions and public officials." That's important because normal state oversight of CIRM does not exist. Neither the governor nor the legislature can alter CIRM's budgets or operations.
One watchdog group, the Foundation for Taxpaper and Consumers Rights, has written to state Controller Steve Westly objecting to any exemption.
John M. Simpson, stem cell project director for the foundation, said:
"Full disclosure of interests of committee members is imperative and they must be seen to be held to the highest ethical standards."It is not hard to conceive of genuine conflicts of interests arising involving the committee. At least two of its six members are very wealthy individuals with a wide array of financial interests. Mrytle Potter, for example, had 25 years of experience as a top executive in the biotech industry, including time with Genentech. Richard Siegal "built (an oil exploration) company that has raised, deployed and accounted for hundreds of millions of invested dollars." He also has donated large sums to various kinds of medical research.
These are extraordinarily capable people who bring valuable experience and insight to CIRM's operations. They also bring a web of financial and business ties that may or may not constitute conflicts of interest as they critique CIRM's financial practices and performance. For example, it is not hard to imagine that an enterprise favored by one of the financial committeee members could find a more friendly reception at CIRM than your average proposal.
We understand the burden that disclosure places on folks such as Siegal and Potter. They may even resign from the committee rather than make a public disclosure. But openness and transparency concerning the public's multibillion dollar investment should come first.
Disclosure Exemptions Are Few
The state has only granted three exemptions from its requirements for public disclosure of the financial interests of high level public officials.
According to the Fair Political Practices Commission, they are for the California Commission on the Fair Administration of Justice, the Medication Errors Panel and the California Alliance to Combat Trafficking and Slavery Task Force.
The regulation permitting exemptions is relatively new, adopted only on Jan. 28 of this year.
The California Stem Cell Report has attempted for several days to determine who was directly responsible for placing the exemption issue on the agenda of the Citizens Financial Accountability Oversight Committee. We have been shuttled between the state controller's office and the Department of Justice without receiving a forthright answer, which may attest to the sensitivity of the issue.
But presumably state Controller Steve Westly put the matter before the committee. He is chair of the committee in question and has control of the agenda.
According to the Fair Political Practices Commission, they are for the California Commission on the Fair Administration of Justice, the Medication Errors Panel and the California Alliance to Combat Trafficking and Slavery Task Force.
The regulation permitting exemptions is relatively new, adopted only on Jan. 28 of this year.
The California Stem Cell Report has attempted for several days to determine who was directly responsible for placing the exemption issue on the agenda of the Citizens Financial Accountability Oversight Committee. We have been shuttled between the state controller's office and the Department of Justice without receiving a forthright answer, which may attest to the sensitivity of the issue.
But presumably state Controller Steve Westly put the matter before the committee. He is chair of the committee in question and has control of the agenda.
Coming Up
Later today we will examine in more detail the proposal to exempt from financial disclosure laws the members of the group charged with overseeing the financial practices of the California stem cell agency.
Senators Scold Visibily Shaken Lanza
The flogging of ACT continues.
Two U.S. senators "lashed out" yesterday and "scolded" Robert Lanza of Advanced Cell Technology of Alameda, Ca., concerning the company's recent announcement of a new method of obtaining embryonic stem cells.
"You're on the ropes!" a combative Arlen Specter, R-Pa., told Lanza, according to an account in the Washington Post written by Rick Weiss, who reported that Lanza was visibily shaken. Sen. Tom Harken, D-Iowa, also scolded Lanza.
Both Harken and Specter support ESC research. They told Lanza at a Senate subcommittee hearing that he and his company have, according to Weiss, "harmed the struggling field by overstating their results."
It is not often that a scientist is blessed with such attention from such august public servants.
Also excoriating ACT, but in a different forum, was Glenn McGee, director of the Alden March Bioethics Institute.
He wrote on his blog:
Two U.S. senators "lashed out" yesterday and "scolded" Robert Lanza of Advanced Cell Technology of Alameda, Ca., concerning the company's recent announcement of a new method of obtaining embryonic stem cells.
"You're on the ropes!" a combative Arlen Specter, R-Pa., told Lanza, according to an account in the Washington Post written by Rick Weiss, who reported that Lanza was visibily shaken. Sen. Tom Harken, D-Iowa, also scolded Lanza.
Both Harken and Specter support ESC research. They told Lanza at a Senate subcommittee hearing that he and his company have, according to Weiss, "harmed the struggling field by overstating their results."
It is not often that a scientist is blessed with such attention from such august public servants.
Also excoriating ACT, but in a different forum, was Glenn McGee, director of the Alden March Bioethics Institute.
He wrote on his blog:
"If there is a school to teach scientists how to screw up the pursuit of PR, ACT has the professors on retainer."McGee continued:
"I continue to be amazed at the degree to which this company manages to do more harm to the battle to get embryonic stem cell research funded than could any concerted right wing campaign against the research. ACT is the Kevorkian of stem cell research."Weighing in from Nature magazine was Alison Abbot. She wrote about the ongoing flap and the magazine's actions, declaring:
"No one is suggesting that Lanza's paper is in any way scientifically incorrect, but many in the field have objected...to its overall packaging. 'Perhaps 'word-smithy' is the right term,' comments George Daley of the Harvard Stem Cell Institute."The Wall Street Journal also carried a piece on Tuesday by David Hamilton and Antonio Regalado, who wrote:
"Advanced Cell has capitalized on the research. Two days after the research was published, the company announced that it had raised $13.5 million from its existing investors, with the first part of the transaction set to close Sept. 7. The company's share price has since fallen considerably since it reached the agreement, closing on Friday, Sept. 1, at 71 cents a share, down more than 70% from the post-announcement high although still above where it was before the announcement."In terms of coverage, it seems interesting that California papers did not pick up on yesterday's Washington hearing, except for a brief report in the Oakland Tribune.
Wednesday, September 06, 2006
New CIRM Auditor Sought in Wake of Copying Flap
The California stem cell agency and its auditor have gone their separate ways, and CIRM is looking for a new, private auditor.
Gilbert Associates, a Sacramento company, conducted an audit for CIRM for the 2004-2005 year, but it generated some complaints when it declined to let the state controller's office copy some documents.
The California Stem Cell Report was told that CIRM and Gilbert severed their relationship by mutual agreement. The issue was the copying of some of Gilbert's working papers on CIRM, a non-negotiable matter for CIRM. Gilbert said at the time the material was proprietary and would not allow copying.
Asked for comment by the California Stem Cell Report, Thomas M. Gilbert, managing shareholder of the accounting firm, referred us to the controller's review of the audit, page 8, which says that his firm would not allow the controller's office to copy working papers it considered proprietary unless the controller's office signed a confidentiality agreement. The controller's office recommended that CIRM "address" the issue.
The bid proposal stipulates that the new auditor "agrees that the state controller’s office shall have the right to review and copy any records and supporting documentation pertaining to the performance of this agreement including, but not limited to, all documents, records and workpapers whether obtained or copied from the institute or developed by the contractor."
It also says the successful bidder must have completed three audits of state agencies in the last five years, preferably ones engaged in bond financing.
Gilbert was slated to work for CIRM through June 30, 2007, under a negotiated, $45,000 contract that was not put out to public bid. The latest contract is being let through the Department of General Services, one of the few occasions that CIRM has used the state's formal public bidding process for its roughly $5 million in outside contracts.
The CIRM contract timeline calls for submission of bids by Sept. 18 with the contract awarded by Sept. 22.
Gilbert Associates, a Sacramento company, conducted an audit for CIRM for the 2004-2005 year, but it generated some complaints when it declined to let the state controller's office copy some documents.
The California Stem Cell Report was told that CIRM and Gilbert severed their relationship by mutual agreement. The issue was the copying of some of Gilbert's working papers on CIRM, a non-negotiable matter for CIRM. Gilbert said at the time the material was proprietary and would not allow copying.
Asked for comment by the California Stem Cell Report, Thomas M. Gilbert, managing shareholder of the accounting firm, referred us to the controller's review of the audit, page 8, which says that his firm would not allow the controller's office to copy working papers it considered proprietary unless the controller's office signed a confidentiality agreement. The controller's office recommended that CIRM "address" the issue.
The bid proposal stipulates that the new auditor "agrees that the state controller’s office shall have the right to review and copy any records and supporting documentation pertaining to the performance of this agreement including, but not limited to, all documents, records and workpapers whether obtained or copied from the institute or developed by the contractor."
It also says the successful bidder must have completed three audits of state agencies in the last five years, preferably ones engaged in bond financing.
Gilbert was slated to work for CIRM through June 30, 2007, under a negotiated, $45,000 contract that was not put out to public bid. The latest contract is being let through the Department of General Services, one of the few occasions that CIRM has used the state's formal public bidding process for its roughly $5 million in outside contracts.
The CIRM contract timeline calls for submission of bids by Sept. 18 with the contract awarded by Sept. 22.
Stem Cell Snippets: Cibelli, IP and Davey
Here are links to some interesting items and press releases related to the California stem cell agency:
Cibelli Update – Not much has changed since about eight months ago when stem cell researcher Jose Cibelli "voluntarily withdrew" from the Standards Working Group of the California stem cell agency in connection with his co-authorship of a fraudulent paper involved in the Korean stem cell scandal. He also asked his employer, Michigan State University, to conduct an investigation. In response to a query from the California Stem Cell Report, an MSU spokeswoman says the investigation is still underway.
WARF – Elizabeth Donley has been named executive director of the WiCell Research Institute, which hosts the National Stem Cell Bank controlling all 21 federally funded stem cell lines. Donley will continue to serve as general counsel to WARF.
IP Policy – Here is a link to the exact language for the proposed regulations on the sharing of patented material by CIRM grantees. The Foundation for Taxpayer and Consumer Rights says it is a "compromise that, while not perfect, will ensure scientists get access to taxpayer-funded discoveries for further research and development."
New CIRM Hire – CIRM has hired Marcia Davey, chief of financial management for the State Department of Insurance, as its interim financial officer for one year. The agency said it is continuing to look for a permanent replacement for retiring Walter Barnes. We are inquiring about Davey's salary.
Cibelli Update – Not much has changed since about eight months ago when stem cell researcher Jose Cibelli "voluntarily withdrew" from the Standards Working Group of the California stem cell agency in connection with his co-authorship of a fraudulent paper involved in the Korean stem cell scandal. He also asked his employer, Michigan State University, to conduct an investigation. In response to a query from the California Stem Cell Report, an MSU spokeswoman says the investigation is still underway.
WARF – Elizabeth Donley has been named executive director of the WiCell Research Institute, which hosts the National Stem Cell Bank controlling all 21 federally funded stem cell lines. Donley will continue to serve as general counsel to WARF.
IP Policy – Here is a link to the exact language for the proposed regulations on the sharing of patented material by CIRM grantees. The Foundation for Taxpayer and Consumer Rights says it is a "compromise that, while not perfect, will ensure scientists get access to taxpayer-funded discoveries for further research and development."
New CIRM Hire – CIRM has hired Marcia Davey, chief of financial management for the State Department of Insurance, as its interim financial officer for one year. The agency said it is continuing to look for a permanent replacement for retiring Walter Barnes. We are inquiring about Davey's salary.
Monday, September 04, 2006
CIRM's Financial Practices to be Reviewed Next Week
A new creature spawned by Prop. 71 will pop onto the public scene for the first time next week in San Francisco.
It is the Citizens Financial Accountability Oversight Committee. The six-member panel is charged with reviewing and making recommendations on CIRM's "financial practices and performance."
Prop. 71, approved nearly two years ago, indicated the committee should prepare an annual report. So far, none has been forthcoming.
At its San Francisco meeting Sept. 14, the first major order of business is a proposal to avoid disclosing the financial interests of its members. It is not clear how the exemption disclosure request came to be on the committee's agenda. The proposal would excuse committee members from filing financial disclosure statements on the grounds that the group has no decision-making authority and has a budget of less than $150,000. State regulations provide for possible exemptions in such cases.
It is apparent from Prop. 71 that the committee can only make suggestions to CIRM and has no power over it, other than public pressure. Presumably its budget is less than $150,000.
The next item calls for consideration of "recommendations" by the committee, none of which have been prepared for public consumption at this point. On the table is the audit paid for by CIRM and the controller's review of that document. Nothing truly scandalous emerged from those reviews, although there was a flap when CIRM's auditor refused to provide copies of information to the controller's office. The accountability panel will not be considering the audit by the California auditor general, which has not yet been released.
State Controller Steve Westly, who is friendly to the stem cell agency, chairs the committee. The proposition calls for appointment of other members who have "medical backgrounds and knowledge of relevant financial matters."
They are:
Richard Siegal, a Westly appointee, philanthropist and patient advocate for Graves Diseases and glaucoma. He also heads what the controller's office only describes as a "private multimillion dollar national energy firm." The firm is Palace Exploration Co. which bizneworleans.com, describes as "a privately held (New York) company engaged in the exploration and production of oil and gas in the continental United States, the Gulf of Mexico, Western Canada and the North Sea. It has been owned and operated by the chairman and his family since its acquisition in 1983, and owns interests in more than 1,400 producing oil or gas wells." Siegal and his wife, Gail, gave $44,600 to Westly's campaign for the Democratic gubernatorial nomination this year, according to Common Cause.
Myrtle Potter, an appointee of CIRM Chair Robert Klein. Potter is a former vice president of Genentech. More recently she was a cofounder of the Chapman Development Group, which operates large-scale residential and commercial development, among other things. In 2003 and 2004, she was named to Fortune magazine's list of the "Top 50 Most Powerful Women in Business."
Daniel S. Brunner, an appointee of treasurer Phil Angelides. The controller's office lists Brunner as "general counsel, (Governor's) Office of Special Health Care Negotiations." However, that appears to be an old occupation. Through January of 2005, he was executive vice president of First Health of Sacramento, Ca., which manages health care services for businesses. Common Cause does not show major contributions from Brunner to Angelides, who defeated Westly in the race for the Democratic gubernatorial nomination.
John Hein of Fair Oaks, Ca., an appointee of Assembly Speaker Fabian Nunez. Hein was executive director of Communities for Quality Education at the time of his appointment. He also served as the chief lobbyist for the California Teachers Association in Sacramento. We are inquiring concerning his current employment.
Jim Lott, an appointee of Senate President Pro Tem Don Perata. Lott is executive vice president of the Hospital Association of Southern California and has an "extensive and productive history in influencing health policy in California." Lott was a former legislative staffer and is chair of the LA Care Health Plan.
Here is a link to the controller's bios on the committee members. Here is a link to the state regulations providing for an exemption on the disclosures (see sec. 18751 C 3).
Below is the text of the section of Prop. 71 creating the committee.
It is the Citizens Financial Accountability Oversight Committee. The six-member panel is charged with reviewing and making recommendations on CIRM's "financial practices and performance."
Prop. 71, approved nearly two years ago, indicated the committee should prepare an annual report. So far, none has been forthcoming.
At its San Francisco meeting Sept. 14, the first major order of business is a proposal to avoid disclosing the financial interests of its members. It is not clear how the exemption disclosure request came to be on the committee's agenda. The proposal would excuse committee members from filing financial disclosure statements on the grounds that the group has no decision-making authority and has a budget of less than $150,000. State regulations provide for possible exemptions in such cases.
It is apparent from Prop. 71 that the committee can only make suggestions to CIRM and has no power over it, other than public pressure. Presumably its budget is less than $150,000.
The next item calls for consideration of "recommendations" by the committee, none of which have been prepared for public consumption at this point. On the table is the audit paid for by CIRM and the controller's review of that document. Nothing truly scandalous emerged from those reviews, although there was a flap when CIRM's auditor refused to provide copies of information to the controller's office. The accountability panel will not be considering the audit by the California auditor general, which has not yet been released.
State Controller Steve Westly, who is friendly to the stem cell agency, chairs the committee. The proposition calls for appointment of other members who have "medical backgrounds and knowledge of relevant financial matters."
They are:
Richard Siegal, a Westly appointee, philanthropist and patient advocate for Graves Diseases and glaucoma. He also heads what the controller's office only describes as a "private multimillion dollar national energy firm." The firm is Palace Exploration Co. which bizneworleans.com, describes as "a privately held (New York) company engaged in the exploration and production of oil and gas in the continental United States, the Gulf of Mexico, Western Canada and the North Sea. It has been owned and operated by the chairman and his family since its acquisition in 1983, and owns interests in more than 1,400 producing oil or gas wells." Siegal and his wife, Gail, gave $44,600 to Westly's campaign for the Democratic gubernatorial nomination this year, according to Common Cause.
Myrtle Potter, an appointee of CIRM Chair Robert Klein. Potter is a former vice president of Genentech. More recently she was a cofounder of the Chapman Development Group, which operates large-scale residential and commercial development, among other things. In 2003 and 2004, she was named to Fortune magazine's list of the "Top 50 Most Powerful Women in Business."
Daniel S. Brunner, an appointee of treasurer Phil Angelides. The controller's office lists Brunner as "general counsel, (Governor's) Office of Special Health Care Negotiations." However, that appears to be an old occupation. Through January of 2005, he was executive vice president of First Health of Sacramento, Ca., which manages health care services for businesses. Common Cause does not show major contributions from Brunner to Angelides, who defeated Westly in the race for the Democratic gubernatorial nomination.
John Hein of Fair Oaks, Ca., an appointee of Assembly Speaker Fabian Nunez. Hein was executive director of Communities for Quality Education at the time of his appointment. He also served as the chief lobbyist for the California Teachers Association in Sacramento. We are inquiring concerning his current employment.
Jim Lott, an appointee of Senate President Pro Tem Don Perata. Lott is executive vice president of the Hospital Association of Southern California and has an "extensive and productive history in influencing health policy in California." Lott was a former legislative staffer and is chair of the LA Care Health Plan.
Here is a link to the controller's bios on the committee members. Here is a link to the state regulations providing for an exemption on the disclosures (see sec. 18751 C 3).
Below is the text of the section of Prop. 71 creating the committee.
Prop. 71 Text on the CFAOC
Here is entire text of what Prop. 71 has to say about the the Citizens Financial Accountability Oversight Committee:
"There shall be a Citizen’s Financial Accountability Oversight Committee chaired by the State Controller. This committee shall review the annual financial audit, the State Controller’s report and evaluation of that audit, and the financial practices of the institute. The State Controller, the State Treasurer, the President pro Tempore of the Senate, the Speaker of the Assembly, and the Chairperson of the ICOC shall each appoint a public member of the committee. Committee members shall have medical backgrounds and knowledge of relevant financial matters. The committee shall provide recommendations on the institute’s financial practices and performance. The State Controller shall provide staff support. The committee shall hold a public meeting, with appropriate notice, and with a formal public comment period. The committee shall evaluate public comments and include appropriate summaries in its annual report. The ICOC shall provide funds for the per diem expenses of the committee members and for publication of the annual report."
"There shall be a Citizen’s Financial Accountability Oversight Committee chaired by the State Controller. This committee shall review the annual financial audit, the State Controller’s report and evaluation of that audit, and the financial practices of the institute. The State Controller, the State Treasurer, the President pro Tempore of the Senate, the Speaker of the Assembly, and the Chairperson of the ICOC shall each appoint a public member of the committee. Committee members shall have medical backgrounds and knowledge of relevant financial matters. The committee shall provide recommendations on the institute’s financial practices and performance. The State Controller shall provide staff support. The committee shall hold a public meeting, with appropriate notice, and with a formal public comment period. The committee shall evaluate public comments and include appropriate summaries in its annual report. The ICOC shall provide funds for the per diem expenses of the committee members and for publication of the annual report."
Friday, September 01, 2006
The Hooha Over ACT: A Case Study in Stem Cell PR
Whatever the scientific merits of Advanced Cell Technology's embryonic stem cell procedure announced last week, critics around the world are flaying the California company.
At the same time, the field of ESC research is taking a hit as opponents use ACT as an example of why science can't be trusted. Parsing the ACT announcement, several press releases, the conduct of Nature magazine and mainstream media reports is a bit convoluted. It is clear, however, that some of the critics do not understand what ACT has done with its experiment.
The episode is a good of example what can happen when the ravening media sees a weakness. The ACT case is not quite a blood feast, but it does have some of the early earmarks. And it is a fine case study for those involved in stem cell public relations, which is just about everybody in the field.
Lesson No. 1 – Idiot proof your press releases. If it can be misinterpreted, it will be. Run those media handouts by several persons who can serve as surrogate reporters. If they can't figure it out, neither can your average ink-stained wretch.
Lesson No. 2 – Clearly delineate the "facts." Separate them from the implications and assume that reporters will have difficulty distinguishing the two.
Lesson No. 3 – Watch the hyperbole.
Lesson No. 4 – Simplify but do not ignore the nuances. Do not assume knowledge. Some science reporters may be able to describe IVF without a crib sheet, but many cannot. As for non-specialized reporters and editors, they need even more help. Give it to them.
Interestingly, the New York Times, the Los Angeles Times, the San Francisco Chronicle and The Sacramento Bee apparently have not yet carried stories on the hooha about the handling of the ACT experiment. Here are some links to other reports: NBC, Wall Street Journal, Washington Post, Philadelphia Inquirer/San Jose Mercury News, BizzyBlog, Bioedge, the Australian, Wired, The Scientist, New Scientist, Ace of Spades and TCSDaily.
At the same time, the field of ESC research is taking a hit as opponents use ACT as an example of why science can't be trusted. Parsing the ACT announcement, several press releases, the conduct of Nature magazine and mainstream media reports is a bit convoluted. It is clear, however, that some of the critics do not understand what ACT has done with its experiment.
The episode is a good of example what can happen when the ravening media sees a weakness. The ACT case is not quite a blood feast, but it does have some of the early earmarks. And it is a fine case study for those involved in stem cell public relations, which is just about everybody in the field.
Lesson No. 1 – Idiot proof your press releases. If it can be misinterpreted, it will be. Run those media handouts by several persons who can serve as surrogate reporters. If they can't figure it out, neither can your average ink-stained wretch.
Lesson No. 2 – Clearly delineate the "facts." Separate them from the implications and assume that reporters will have difficulty distinguishing the two.
Lesson No. 3 – Watch the hyperbole.
Lesson No. 4 – Simplify but do not ignore the nuances. Do not assume knowledge. Some science reporters may be able to describe IVF without a crib sheet, but many cannot. As for non-specialized reporters and editors, they need even more help. Give it to them.
Interestingly, the New York Times, the Los Angeles Times, the San Francisco Chronicle and The Sacramento Bee apparently have not yet carried stories on the hooha about the handling of the ACT experiment. Here are some links to other reports: NBC, Wall Street Journal, Washington Post, Philadelphia Inquirer/San Jose Mercury News, BizzyBlog, Bioedge, the Australian, Wired, The Scientist, New Scientist, Ace of Spades and TCSDaily.
Thursday, August 31, 2006
The Thinking on the Sole Negative Vote on the Egg Donor Bill
California State Sen. Debra Bowen was the only senator to vote "no" today on legislation to protect women egg donors.
The Democrat from the Los Angeles area (Redondo Beach) defeated the author of the egg bill (SB1260), Sen. Deborah Ortiz, in the June primary in the race for the Democratic nomination for California secretary of state.
We asked Bowen's office for a statement on the negative vote. Here is the verbatim comment from Bowen:
“I am concerned that prohibiting women from being paid for their eggs or for participating in research singles them out from how other medical research subjects are treated. That, in turn, is likely to reduce the number of women who can or will take part in embryonic stem cell research.”
See the item below for more on the bill itself.
The Democrat from the Los Angeles area (Redondo Beach) defeated the author of the egg bill (SB1260), Sen. Deborah Ortiz, in the June primary in the race for the Democratic nomination for California secretary of state.
We asked Bowen's office for a statement on the negative vote. Here is the verbatim comment from Bowen:
“I am concerned that prohibiting women from being paid for their eggs or for participating in research singles them out from how other medical research subjects are treated. That, in turn, is likely to reduce the number of women who can or will take part in embryonic stem cell research.”
See the item below for more on the bill itself.
Ortiz' Legislation to Protect Egg Donors Goes to Governor
Only a few months are left in the legislative career of state Sen. Deborah Ortiz, and she is wrapping it up with successful passage of legislation to protect women who donate eggs for stem cell research.
Ortiz was an early and influential figure in California stem cell issues. The Sacramento Democrat carried legislation in 2002 that made California the first state in the nation to authorize embryonic stem cell research. She is credited by some with originating the idea of taking a stem cell initiative to the ballot in California, which ultimately was the mechanism that created the California stem cell agency.
Her egg donor bill went to the governor today on a 34-1 vote in the California State Senate when it concurred in Assembly amendments to the measure – SB1260.
Ortiz' office issued a press release that quoted the legislator, who is being termed out, as saying:
Ortiz' measure also was drafted to be consistent with the existing regulations of the stem cell agency. Implementation of the measure is through the Department of Health Services. Currently an advisory committee is in the process of drafting proposed regulations. Its next meeting is Sept. 20 in Berkeley.
Here is a link to the latest legislative staff analysis of the bill. Here is a link to the bill.
(For those of you unfamiliar with American political terminology, "termed out" means that she is leaving office as the result of a law that limits the number of terms that a person can serve in a particular position.)
Ortiz was an early and influential figure in California stem cell issues. The Sacramento Democrat carried legislation in 2002 that made California the first state in the nation to authorize embryonic stem cell research. She is credited by some with originating the idea of taking a stem cell initiative to the ballot in California, which ultimately was the mechanism that created the California stem cell agency.
Her egg donor bill went to the governor today on a 34-1 vote in the California State Senate when it concurred in Assembly amendments to the measure – SB1260.
Ortiz' office issued a press release that quoted the legislator, who is being termed out, as saying:
“Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans. We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.”The bill also lays the groundwork for regulation of embryonic stem cell research in California – outside of that funded by the California stem cell agency, which operates under a unique initiative measure that does not permit the legislature or the governor to fiddle with its procedures or funding.
Ortiz' measure also was drafted to be consistent with the existing regulations of the stem cell agency. Implementation of the measure is through the Department of Health Services. Currently an advisory committee is in the process of drafting proposed regulations. Its next meeting is Sept. 20 in Berkeley.
Here is a link to the latest legislative staff analysis of the bill. Here is a link to the bill.
(For those of you unfamiliar with American political terminology, "termed out" means that she is leaving office as the result of a law that limits the number of terms that a person can serve in a particular position.)
"Pay the Ladies, Please," Say Two From Academe
Legislation to protect egg donors and regulate embryonic stem cell research in California – outside of CIRM-funded efforts -- is now on the state Senate floor where it appears certain to be approved and go to the governor's desk.
However, the measure (SB1260) by Sen. Deborah Ortiz, D-Sacramento, has drawn fire from two UCLA law professors who argue that it "threatens the future of stem cell research" in California because it would bar payment for eggs.
Russell Korobkin and Judith Daar criticized the bill as "shortsighted" in an op-ed piece in the Los Angeles Times.
Here are some excerpts:
Here is a link to the analysis of SB1260 prepared for use in the Senate floor debate on the bill.
However, the measure (SB1260) by Sen. Deborah Ortiz, D-Sacramento, has drawn fire from two UCLA law professors who argue that it "threatens the future of stem cell research" in California because it would bar payment for eggs.
Russell Korobkin and Judith Daar criticized the bill as "shortsighted" in an op-ed piece in the Los Angeles Times.
Here are some excerpts:
"The primary justification offered for banning compensation to egg donors is that financial incentives will unduly induce women, particularly those of lower socioeconomic status, to undergo egg extraction without fully considering the significant risks and inconveniences associated with the weeks-long process, which requires hormone injections and minor surgery. Money, it is argued, will enable overzealous scientists to coerce women to become egg providers.Whatever the strength of their argument, it comes much too late to have an impact on the measure. It is also not likely to be cited during debate on the Senate floor. Paying egg donors is not a political third rail, but few, if any legislators are likely to support such a move.
"This argument relies on an unusual and indefensible view of what constitutes coercion. In a free-market economy, financial inducements are ubiquitous, especially when socially valuable activities entail some degree of risk or inconvenience. Coal mining is dirty and dangerous work, but we don't claim that paying miners is coercive and expect altruists to do the job for free. Certainly there is no movement afoot to ban payments to soldiers or peace officers in the name of protecting them against placing themselves in harm's way for profit. In fact, just the opposite. We sometimes provide extra hazard pay to public servants who take on the greatest risks in recognition of their valuable contributions.
"If anything, ethics requires the affirmative compensation of individuals who sacrifice so that the rest of us can reap the benefits of biomedical research. Medical research subjects commonly are paid a fee for their participation. There is no justification for ushering women of reproductive age into a separate and wholly unequal category — ineligible for compensation solely because of the nature of their research participation."
Here is a link to the analysis of SB1260 prepared for use in the Senate floor debate on the bill.
Wednesday, August 30, 2006
CIRM IP Group Changes Research Usage Exemption
The California stem cell agency's Task Force on Intellectual Property has revised requirements for sharing inventions developed as the result of grants to nonprofit research organizations.
California biomedical firms objected to the previous language. The latest version was hammered out a meeting of the Task Force following comments from its members and others.
The new language, which will be posted on the CIRM website as part of the administrative rules procedures, stipulates that grantees make CIRM-funded patented inventions "readily accessible on reasonable terms to other grantee organizations."
Some members of the Oversight Committee, in addition to the business groups, were concerned that the previous language (known as the Research Use Exemption - RUE) would remove incentives to market and distribute useful research tools.
Janet Lambert, director of government relations for Invitrogen of Carlsbad, Ca., flew out from Washington, D.C., to present her company's point of view. She and others, including John M. Simpson, stem cell director of the Foundation for Taxpayer and Consumer Rights, worked out the compromise language in the rear of the room as the Task Force dealt with other issues.
Part of the backdrop for discussion for the language was "The WARF Problem." Repeatedly speakers said they did not want to emulate the example of the Wisconsin Alumni Research Foundation, which holds key patents to embryonic stem cells. The foundation has been the subject of sharp criticism for failing to allow use of the patents more widely and less expensively.
CIRM President Zach Hall argued for wider distribution of CIRM-funded research. He said he did not want to see a situation where "we can't communicate with our (scientific) neighbors."
Members of the Task Force. Including Jeff Sheehy, also raised questions about how the previous language was arrived at and the process of involving "stakeholders" in discussions. Sheehy said he was "very uncomfortable" about a discussion process that would seem to favor some stakeholders over others.
Once the new language is officially published, that will trigger another 15-day comment period. You can see details of the administrative rules process here.
California biomedical firms objected to the previous language. The latest version was hammered out a meeting of the Task Force following comments from its members and others.
The new language, which will be posted on the CIRM website as part of the administrative rules procedures, stipulates that grantees make CIRM-funded patented inventions "readily accessible on reasonable terms to other grantee organizations."
Some members of the Oversight Committee, in addition to the business groups, were concerned that the previous language (known as the Research Use Exemption - RUE) would remove incentives to market and distribute useful research tools.
Janet Lambert, director of government relations for Invitrogen of Carlsbad, Ca., flew out from Washington, D.C., to present her company's point of view. She and others, including John M. Simpson, stem cell director of the Foundation for Taxpayer and Consumer Rights, worked out the compromise language in the rear of the room as the Task Force dealt with other issues.
Part of the backdrop for discussion for the language was "The WARF Problem." Repeatedly speakers said they did not want to emulate the example of the Wisconsin Alumni Research Foundation, which holds key patents to embryonic stem cells. The foundation has been the subject of sharp criticism for failing to allow use of the patents more widely and less expensively.
CIRM President Zach Hall argued for wider distribution of CIRM-funded research. He said he did not want to see a situation where "we can't communicate with our (scientific) neighbors."
Members of the Task Force. Including Jeff Sheehy, also raised questions about how the previous language was arrived at and the process of involving "stakeholders" in discussions. Sheehy said he was "very uncomfortable" about a discussion process that would seem to favor some stakeholders over others.
Once the new language is officially published, that will trigger another 15-day comment period. You can see details of the administrative rules process here.
Correction
On Aug. 29, we carried an item (see below) on CIRM principles for grants to businesses that incorrectly said, “If the grantee chooses to develop a product themselves, the state would receive some sort of multiple of CIRM funding after the 'success' of the product. Discussion seemed to favor a multiple in the 3 to 5 percent range, leaning strongly to the lower end.”
The item should have said that the multiple being considered was a multiple of total CIRM funding. For example, if the CIRM funding is $1 million, the return could be $3 million to $5 million.
Our thanks to the CIRM staff for pointing out the error.
The item should have said that the multiple being considered was a multiple of total CIRM funding. For example, if the CIRM funding is $1 million, the return could be $3 million to $5 million.
Our thanks to the CIRM staff for pointing out the error.
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