The Intellectual Property Task Force of the California stem cell agency has met its self-imposed deadline for posting a proposed draft of its rules for sharing the swag.
Last month, Ed Penhoet, chair of the task force, swore that the draft, to be considered by the Oversight Committee this Friday, would be available online by Feb. 5. It was posted at least by Feb. 4. You can read it here.
However, the rest of the agenda for the Oversight Committee consists of little more than brief notations with no backup material, as is usually the case, with only three business days left before the meeting. The Oversight Committee will be very busy at its Stanford session. Not only is intellectual property up for discussion but also proposed rules for ethics and research. Either IP or ethics could easily take up a full day, if the committee had time.
We expect to see more background material on CIRM website, perhaps on Wednesday or Thursday. We will carry items on the material, as warranted.
If you are planning on attending the Stanford meeting, you may want to visit the Stanford web site to figure out parking arrangements, which can be difficult and expensive. We are also told the campus police vigilantly ticket offenders.
Monday, February 06, 2006
Thursday, February 02, 2006
'Unbalanced?' but 'Very Good'
It is something of an odd company.
Aphidwatch.com. DNA binding, the National Academies Web site on evolution...and the California Stem Cell Report. What do they all have in common? A write-up in a review of websites in the Genetic Engineering News, which says it is most widely read bionews publication in the world with a "market reach" of 199,143.
The Web site review, which the magazine calls one of it most popular features, is written by Kevin Ahern, who teaches in the biochemistry and biophysics department at Oregon State University.
His bottom line on the California Stem Cell Report:
His summary:
We should note that Ahern's snippet on the California Stem Cell Report was only one item removed from another on foot-and-mouth disease.
Aphidwatch.com. DNA binding, the National Academies Web site on evolution...and the California Stem Cell Report. What do they all have in common? A write-up in a review of websites in the Genetic Engineering News, which says it is most widely read bionews publication in the world with a "market reach" of 199,143.
The Web site review, which the magazine calls one of it most popular features, is written by Kevin Ahern, who teaches in the biochemistry and biophysics department at Oregon State University.
His bottom line on the California Stem Cell Report:
"The best way to keep informed on this topic may be to watch this site."
His summary:
"Strong Points: Topical ; Weak Points: Unbalanced? ; Rating: Very Good "
We should note that Ahern's snippet on the California Stem Cell Report was only one item removed from another on foot-and-mouth disease.
Disclosure of Researchers' Financial Interests to Subjects Recommended
A couple of UCLA law professors have published a research paper exploring stem cell research and the law, ranging from informed consent to the law of human tissue to patents.
Russell Korobkin and Stephen Munzer prepared the 112-page research paper published by the UCLA School of Law. Dated this month, it is a thorough and timely overview of the issues.
A couple of items caught our attention. One of their recommendations calls for full disclosure of the financial interests of researchers to their human subjects.
They also support some sort of compensation for donors, a position the California stem cell agency opposes. They wrote that it "should be possible for donors to receive non-cash compensation and for 'disease groups' to negotiate for royalties or treatment."
They continued:
Russell Korobkin and Stephen Munzer prepared the 112-page research paper published by the UCLA School of Law. Dated this month, it is a thorough and timely overview of the issues.
A couple of items caught our attention. One of their recommendations calls for full disclosure of the financial interests of researchers to their human subjects.
"Requiring such disclosure would not, despite what the court asserts, 'chill medical research.' Further, the autonomy principle suggests that disclosure of financial interests is even greater in non-therapeutic contexts where subjects lack the incentive to participate in research in order to obtain direct health benefits. The law should require the full disclosure of scientists’financial interests, if any, in the results of their research."
They also support some sort of compensation for donors, a position the California stem cell agency opposes. They wrote that it "should be possible for donors to receive non-cash compensation and for 'disease groups' to negotiate for royalties or treatment."
They continued:
"The greatest concerns with undermining human dignity arise in the context of the sale of embryos, for they have the potential to develop into human beings. Even in this context, however, we are wary of prohibitions. There is reason to believe that human dignity is better protected if the availability of compensation for unused embryos enables people , who otherwise could not afford IVF, to use that process to create a baby."
Wednesday, February 01, 2006
Light Coverage of Stem Cell Research Standards
Only two California newspapers seem to have covered this week's important developments on the ethics of state-funded stem cell research and initial approval of standards that are certain to set a new bar nationally.
We have already noted The Bee's coverage. Reporter Sandi Dolbee of the San Diego Union-Tribune also produced a piece this morning with some interesting details. Dolbee's article made it clear that reimbursement of egg donors for lost wages was okay. And she noted a dissent from a member of the public.
The Bee reported some disagreement among members of the CIRM working group concerning the compensation issue.
Other newspapers may have carried reports on the standards, but they did not appear in the usual Web searches. We checked the Los Angeles Times site specifically since the standards meeting was in Los Angeles. We also checked the San Francisco Chronicle site specifically since CIRM is a hometown agency. Neither appears to have covered the matter.
We have already noted The Bee's coverage. Reporter Sandi Dolbee of the San Diego Union-Tribune also produced a piece this morning with some interesting details. Dolbee's article made it clear that reimbursement of egg donors for lost wages was okay. And she noted a dissent from a member of the public.
"'I think this compliance section is pathetically thin,' said Susan Berke Fogel, founder of the Pro-Choice Alliance for Responsible Research, who wanted more specifics about enforcing the rules."
The Bee reported some disagreement among members of the CIRM working group concerning the compensation issue.
"Several working group members contended women should profit because egg extraction is onerous and potentially risky.
"Ann Kiessling, a Harvard University biologist who runs an independent nonprofit lab harvesting eggs for stem cell research, said donors spend up to 200 hours on travel, legal reviews and medical procedures to provide eggs for research.
"'That women shouldn't be compensated is the most unethical position,' said panel member Jonathan Shestack."
Other newspapers may have carried reports on the standards, but they did not appear in the usual Web searches. We checked the Los Angeles Times site specifically since the standards meeting was in Los Angeles. We also checked the San Francisco Chronicle site specifically since CIRM is a hometown agency. Neither appears to have covered the matter.
Can the Research Standards be Policed?
A lengthier version of The Sacramento Bee story on the stem cell research standards is now available on The Bee's website. Among other things, it says,
Lo said he believed CIRM would have sufficient staff to police the standards.
"Jesse Reynolds, Center for Genetics and Society program director, complained that potential grantees got a private meeting with the agency's staff to give their input on the guidelines in December. He also said the state's stem cell institute doesn't have enough staff to effectively police researchers' compliance with the standards."The article also said,
"'What we did is so far ahead of the rest of the United States that I think these will become the national standards,' said Bernard Lo, the working group's co-chair. 'We really want to be in the lead here in terms of ethical standards, as well as the research.'"
Lo said he believed CIRM would have sufficient staff to police the standards.
Tuesday, January 31, 2006
Bee Reports Tersely on CIRM Research Standards
The Sacramento Bee calls protection of women who donate eggs for stem cell research the "toughest ethical issue" facing the California stem cell agency.
Reporter Laura Mecoy wrote the story on Tuesday's approval of the proposed research standards by the agency's Standards Working Group. Her brief article also had this from Zach Hall, president of CIRM:
Reporter Laura Mecoy wrote the story on Tuesday's approval of the proposed research standards by the agency's Standards Working Group. Her brief article also had this from Zach Hall, president of CIRM:
"We are going beyond existing standards. It becomes a much bigger issue with the South Korean debacle . . . Now the big need in the research field is to try to figure how to make this technology work in humans, and egg donation will be the key."
CIRM Readying Egg Donor Protections
The California stem cell agency said today it is moving ahead with rules to ensure that state-funded research does not use eggs from women who were paid to donate them. It also said it is intends to ensure that research institutions cover any medical care needed by donors as a result of complications in the egg donation process.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said that the agency was making it clear there would be no loophole for eggs that may have been paid for and procured overseas, which he and the Center for Genetics and Society had raised concerns about.
“This loophole is just the latest example of why public oversight and control of Prop. 71 research is so important. This case is a good example that when the public speaks out, policymakers can listen," Simpson said in a press release.
CIRM issued a press release summarizing Monday's decisions by the Standards Working Group. The statement did not detail the mechanism to be used to ensure that payments were not being made for eggs.
Here are the key paragraphs from the release on the standards group recommendations to the Oversight Committee.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said that the agency was making it clear there would be no loophole for eggs that may have been paid for and procured overseas, which he and the Center for Genetics and Society had raised concerns about.
“This loophole is just the latest example of why public oversight and control of Prop. 71 research is so important. This case is a good example that when the public speaks out, policymakers can listen," Simpson said in a press release.
CIRM issued a press release summarizing Monday's decisions by the Standards Working Group. The statement did not detail the mechanism to be used to ensure that payments were not being made for eggs.
Here are the key paragraphs from the release on the standards group recommendations to the Oversight Committee.
Adopt "a broad definition of 'covered stem cell lines' to ensure that human stem cells derived from any source are subject to strict ethical standards. Guidelines for Human Embryonic Stem Cell Research, published by the National Academies, only covered embryonic stem cell lines."
Create "a single 'gold' standard intended to ensure that all cell lines used by CIRM-funded researchers are derived according to the highest ethical standards. This revised standard has the practical implication of guaranteeing that all cell lines used by CIRM-funded researchers are derived without payment to egg donors."
Require that "research institutions ensure that oocyte donors do not have to pay for any immediate and short-term complications for oocyte retrieval. The National Academies’ guidelines make no mention of this issue."
"Strengthen existing regulations to make clear that it is not acceptable to provide payments for eggs (beyond reimbursement for expenses) used in CIRM-funded research under any circumstances."
"Reaffirm that the Draft CIRM Regulations go above and beyond state regulations and federal guidelines for assuring that potential eggs donors are fully informed of their decision and the research. Institutional review committees are required to approve a process for determining whether prospective donors have understood the essential aspects of the research, including but not limited to how eggs will be used and the medical risks associated with participation."
Monday, January 30, 2006
Standards Meeting Report from the Alliance for Stem Cell Research
More on the ethics of stem cell research, informed consent and the issue of cash-for-eggs today at a meeting of the Standards Working Group in Los Angeles from folks who were there.
Unfortunately we were not able to attend, and the CIRM event was not available at offsite locations or on the Web. So we asked some of the regular observers -- critics and supporters of CIRM -- if they were interested in sending us a report from the trenches. CIRM was invited as well. We promised to publish the reports verbatim.
The following is from Susan DeLaurentis, president and CEO of the Alliance for Stem Cell Research. Like Don Reed, who reported in an earlier item, she is an unabashed supporter of CIRM. Here are her comments.
Last week, I left the IP Task Force meeting (from a remote location-UCLA) feeling hopeful that a spirit of collaboration had finally begun to be realized. The public's input was listened to, respected and incorporated into the draft regulations. The concerns of Senator Deborah Ortiz, reflected in her proposed constitutional amendment, SCA 13, had been principally addressed. And the entire process felt open and inclusive.
Today's meeting of the CIRM Standards Working Group continued that same inclusive and collaborative spirit. It was made clear that the input of the public was a necessary component to crafting the best possible standards for stem cell research. And, again, the concerns of Senator Ortiz, reflected in her legislation, SB18, were principally addressed. There was extensive discussion about the informed consent process and the protections for women who donate eggs for research.
Finally, there is a true synergy with the CIRM, the public, and the legislature.
Our hope is that this spirit of partnership and respect continues. The full ICOC meeting at Stanford next week will be a great opportunity for all of us representing the public to see if this is the case. This is what we expected from the CIRM and the promise of open meetings. And, finally, this is what we are getting.
Unfortunately we were not able to attend, and the CIRM event was not available at offsite locations or on the Web. So we asked some of the regular observers -- critics and supporters of CIRM -- if they were interested in sending us a report from the trenches. CIRM was invited as well. We promised to publish the reports verbatim.
The following is from Susan DeLaurentis, president and CEO of the Alliance for Stem Cell Research. Like Don Reed, who reported in an earlier item, she is an unabashed supporter of CIRM. Here are her comments.
Last week, I left the IP Task Force meeting (from a remote location-UCLA) feeling hopeful that a spirit of collaboration had finally begun to be realized. The public's input was listened to, respected and incorporated into the draft regulations. The concerns of Senator Deborah Ortiz, reflected in her proposed constitutional amendment, SCA 13, had been principally addressed. And the entire process felt open and inclusive.
Today's meeting of the CIRM Standards Working Group continued that same inclusive and collaborative spirit. It was made clear that the input of the public was a necessary component to crafting the best possible standards for stem cell research. And, again, the concerns of Senator Ortiz, reflected in her legislation, SB18, were principally addressed. There was extensive discussion about the informed consent process and the protections for women who donate eggs for research.
Finally, there is a true synergy with the CIRM, the public, and the legislature.
Our hope is that this spirit of partnership and respect continues. The full ICOC meeting at Stanford next week will be a great opportunity for all of us representing the public to see if this is the case. This is what we expected from the CIRM and the promise of open meetings. And, finally, this is what we are getting.
The Bee: Kudos to CIRM
The Sacramento Bee has been one of the toughest critics of the California stem cell agency, taking it to task for everything from salaries to ethics.
But this past weekend, the newspaper editorialized very favorably about the agency's proposed policy on how to divide up the booty from CIRM-financed inventions.
The Bee wrote:
But this past weekend, the newspaper editorialized very favorably about the agency's proposed policy on how to divide up the booty from CIRM-financed inventions.
The Bee wrote:
"Not long ago, certain biotech leaders and university officials were urging California's $3 billion stem cell institute to renege on a promise to return royalties to the state. An outcry erupted from watchdog groups, Democratic state Sen. Deborah Ortiz of Sacramento and others.The Bee continued:
Apparently, the institute listened."
"Some questions remain on how the state would enforce all of these policies. Even so, they represent a good-faith effort by the institute to listen and respond to public concerns. Kudos to Ed Penhoet, who led the task force and co-chairs the institute's oversight committee. Ortiz and others also deserve credit."
A Report from a Patient Advocate on Today's Ethics Meeting
The ethics of stem cell research, informed consent and the issue of cash-for-eggs were on the agenda today at a meeting of the Standards Working Group in Los Angeles – a session that will continue Tuesday.
Unfortunately we were not able to attend, and the CIRM event was not available at offsite locations or on the Web. So we asked some of the regular observers -- critics and supporters of CIRM -- if they were interested in sending us a report from the trenches. CIRM was invited as well. We promised to publish the reports verbatim.
The first comes from Don Reed, an unabashed fan of the stem cell agency. His account includes a report about discussion by the working group of the Korean scandal and an apparent decision to bar use of any eggs from either outside or inside California that were obtained through compensation. Reimbursement of expenses is apparently allowed. Here is Reed's account, including his headline.
CIRM BREAKS NEW GROUND IN SCIENTIFIC ACCOUNTABILITY
The California Institute for Regenerative Medicine wrestled with intellectual and ethical issues in an eight-hour meeting today, culminating in new standards for egg donor reimbursments and standards for stem cell lines.
It was pointed out that the scientists in the room had published more than one thousand peer-reviewed scientific papers. If brain power and heart were electricity, we could have powered a city!
“Are we talking eggs today?” one bystander questioned Dr. Ann Kiessling, director of the Bedford Stem Cell Research Foundation, and so it proved.
The meeting was called to order by Sherry Lansing, former President of Paramount Motion Pictures Studios.
“Seven months work by many people have been brought together today,” she said, “Today and tomorrow, we will make our recommendations, adding them to the many pages of written submissions and oral contributions by the public. This will be discussed and decided upon by the Independent Citizens’ Oversight Committee .”
An immediate controversy was raised by Ms. Lansing, referring to the voluntary leave of absence taken by Dr. Jose Cibelli. Dr. Cibelli was a writer on a paper by Hwang Wu Suk of South Korea, who has been involved in a major scandal. Dr. Cibelli has asked that his work be investigated by his home college, and that he be allowed a leave of absence until the matter is settled.
CIRM President Dr. Zach Hall stressed that the presumption of innocence applies here, as it does for every American.
One audience member asked how we could be sure fraud did not happen here in California?
Dr. Hall pointed out that Hwang’s misdeeds were pointed out by his fellow scientists.
False science will inevitably be brought to light when other scientists try to build on it. Truth stands; lies collapse. When another worker in the field attempts to replicate the experiment, and finds out it does not work, the falsity becomes clear.
Co-chair Bernie Lo, ethicist, pointed out the multiple layers of checks and counterchecks the California system is blessed with in the oversight area. In addition to groups like the Internal Review Boards (IRBs) and(Stem Cell Research Oversight committees (SCROs) which will keep track of the experiments, and the committee of out-of-state scientists who review the project’s feasibility before funding is even considered, the Independent Citizens’ Oversight Committee and the entire staff of CIRM have no more important assignment than maintaining the integrity of California’s stem cell research program.
Anyone who wonders how the California stem cell research program works should come to any of the many public meetings like today’s, one of 57 so far in the CIRM’s short existence.
For example, California has set a very high standard for the obtainment of stem cell lines, including no compensation for the egg donors who help in the making of the colonies of cells.
But can we expect poor women to donate eggs if they cannot afford time off from work?
Compensation no, reimbursement, yes; that was the answer which emerged after several hours of debate among scientists, ethicists, and the public.
Now, what about other countries which do pay donors? Can we use their stem cell lines, which do not follow our ethical guidelines?
I personally wanted the answer to be yes, because we need stem cell lines, and also because I think women should be paid handsomely for their gift to the world.
But the board decided that not only did we have to go by the highest standard, but also so did anyone whose stem cell lines we might want to use.
This slows us down.
But it is typical of the go-the-extra-mile attitude of everyone connected to the California stem cell program.
But don’t take my word for it.
Come to the next meeting and see for yourself.
Just go to www.CIRM.CA.gov and click on Upcoming meetings.
You are welcome.
Unfortunately we were not able to attend, and the CIRM event was not available at offsite locations or on the Web. So we asked some of the regular observers -- critics and supporters of CIRM -- if they were interested in sending us a report from the trenches. CIRM was invited as well. We promised to publish the reports verbatim.
The first comes from Don Reed, an unabashed fan of the stem cell agency. His account includes a report about discussion by the working group of the Korean scandal and an apparent decision to bar use of any eggs from either outside or inside California that were obtained through compensation. Reimbursement of expenses is apparently allowed. Here is Reed's account, including his headline.
CIRM BREAKS NEW GROUND IN SCIENTIFIC ACCOUNTABILITY
The California Institute for Regenerative Medicine wrestled with intellectual and ethical issues in an eight-hour meeting today, culminating in new standards for egg donor reimbursments and standards for stem cell lines.
It was pointed out that the scientists in the room had published more than one thousand peer-reviewed scientific papers. If brain power and heart were electricity, we could have powered a city!
“Are we talking eggs today?” one bystander questioned Dr. Ann Kiessling, director of the Bedford Stem Cell Research Foundation, and so it proved.
The meeting was called to order by Sherry Lansing, former President of Paramount Motion Pictures Studios.
“Seven months work by many people have been brought together today,” she said, “Today and tomorrow, we will make our recommendations, adding them to the many pages of written submissions and oral contributions by the public. This will be discussed and decided upon by the Independent Citizens’ Oversight Committee .”
An immediate controversy was raised by Ms. Lansing, referring to the voluntary leave of absence taken by Dr. Jose Cibelli. Dr. Cibelli was a writer on a paper by Hwang Wu Suk of South Korea, who has been involved in a major scandal. Dr. Cibelli has asked that his work be investigated by his home college, and that he be allowed a leave of absence until the matter is settled.
CIRM President Dr. Zach Hall stressed that the presumption of innocence applies here, as it does for every American.
One audience member asked how we could be sure fraud did not happen here in California?
Dr. Hall pointed out that Hwang’s misdeeds were pointed out by his fellow scientists.
False science will inevitably be brought to light when other scientists try to build on it. Truth stands; lies collapse. When another worker in the field attempts to replicate the experiment, and finds out it does not work, the falsity becomes clear.
Co-chair Bernie Lo, ethicist, pointed out the multiple layers of checks and counterchecks the California system is blessed with in the oversight area. In addition to groups like the Internal Review Boards (IRBs) and(Stem Cell Research Oversight committees (SCROs) which will keep track of the experiments, and the committee of out-of-state scientists who review the project’s feasibility before funding is even considered, the Independent Citizens’ Oversight Committee and the entire staff of CIRM have no more important assignment than maintaining the integrity of California’s stem cell research program.
Anyone who wonders how the California stem cell research program works should come to any of the many public meetings like today’s, one of 57 so far in the CIRM’s short existence.
For example, California has set a very high standard for the obtainment of stem cell lines, including no compensation for the egg donors who help in the making of the colonies of cells.
But can we expect poor women to donate eggs if they cannot afford time off from work?
Compensation no, reimbursement, yes; that was the answer which emerged after several hours of debate among scientists, ethicists, and the public.
Now, what about other countries which do pay donors? Can we use their stem cell lines, which do not follow our ethical guidelines?
I personally wanted the answer to be yes, because we need stem cell lines, and also because I think women should be paid handsomely for their gift to the world.
But the board decided that not only did we have to go by the highest standard, but also so did anyone whose stem cell lines we might want to use.
This slows us down.
But it is typical of the go-the-extra-mile attitude of everyone connected to the California stem cell program.
But don’t take my word for it.
Come to the next meeting and see for yourself.
Just go to www.CIRM.CA.gov and click on Upcoming meetings.
You are welcome.
Ortiz Praises Proposed IP Policies -- With Caveats
A key California legislator and the California stem cell agency seem to be edging closer to an agreement on how the state should benefit from inventions funded by CIRM.
The latest indication came in identical letters Monday from Sen. Deborah Ortiz, D-Sacramento, to Robert Klein and Ed Penhoet, chair and vice chair respectively of the agency. She praised the draft intellectual property policies that are expected to come before the Oversight Committee on Feb. 10. She said they would help ensure that CIRM-funded inventions "are freely available to researchers, that California taxpayers see a return on their investment, and that all Californians have access to the stem cell therapies made possible through Proposition 71."
Ortiz is chair of the Senate Health Committee and author of a proposed constitutional amendment dealing with stem cell IP issues, among other matters. She has indicated that the concerns motivating the measure could be satisfied without actually placing the measure on the ballot.
However, she said that the proposed IP policies should be regarded as a floor for IP agreements and that the Oversight Committee "should negotiate higher economic benefits for the state when feasible without impeding important research."
She said they should not preclude the state from requiring a larger share of royalties if taxable bonds are used to fund the research. She also said that the proposed policy to require sale of CIRM-based therapies at the lowest cost to the state should be extended to county health programs and community clinics.
A copy of the Ortiz letter follows below since it is not available on the Web at the time of this writing.
The latest indication came in identical letters Monday from Sen. Deborah Ortiz, D-Sacramento, to Robert Klein and Ed Penhoet, chair and vice chair respectively of the agency. She praised the draft intellectual property policies that are expected to come before the Oversight Committee on Feb. 10. She said they would help ensure that CIRM-funded inventions "are freely available to researchers, that California taxpayers see a return on their investment, and that all Californians have access to the stem cell therapies made possible through Proposition 71."
Ortiz is chair of the Senate Health Committee and author of a proposed constitutional amendment dealing with stem cell IP issues, among other matters. She has indicated that the concerns motivating the measure could be satisfied without actually placing the measure on the ballot.
However, she said that the proposed IP policies should be regarded as a floor for IP agreements and that the Oversight Committee "should negotiate higher economic benefits for the state when feasible without impeding important research."
She said they should not preclude the state from requiring a larger share of royalties if taxable bonds are used to fund the research. She also said that the proposed policy to require sale of CIRM-based therapies at the lowest cost to the state should be extended to county health programs and community clinics.
A copy of the Ortiz letter follows below since it is not available on the Web at the time of this writing.
Text of Ortiz Letter to Klein, Penhoet
Here is a copy of the Jan. 30, 2006, letter from Ortiz to Klein and Penhoet.
I want to commend the Independent Citizen’s Oversight Committee (ICOC) working group on intellectual property for the progress it has made in developing a proposed policy for handling intellectual property for grants to nonprofit organizations from the California Institute for Regenerative Medicine (CIRM). The proposed policy will help ensure that findings and discoveries developed with Proposition 71 funds In particular, I support and urge the ICOC to adopt the proposed policies requiring grantees to negotiate nonexclusive licenses of CIRM-funded inventions wherever possible, make licensed inventions reasonably accessible for research purposes, and make CIRM-funded patented inventions available at no cost for further research. These policies will ensure that research findings and inventions developed with Proposition 71 funds are freely and openly disseminated among researchers.
I similarly support the proposed requirements that grantees share 25 percent of net royalties received with the state and that they license inventions to organizations that 1) agree to provide resulting therapies to Medi-Cal and other state health care programs at the lowest cost they provide them to other purchasers and 2) have plans for access to the therapies for uninsured patients.
Finally, I agree that CIRM must retain march-in rights in cases where grantees or licensees have not made reasonable efforts to achieve practical application of a CIRM-funded patented invention.
However, I believe it is important that the proposed policies be regarded as a floor for negotiation of intellectual property agreements. I believe the ICOC. I believe this is required by the balancing language of Proposition 71, which clearly states the “ICOC shall establish standards that require that all grants and loan awards be subject to intellectual property agreements that balance the opportunity of the State of California to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials with the need to assure that essential medical research is not unreasonably hindered by the intellectual property agreements.”
The policy also should not preclude the ICOC from requiring a larger share of royalties when necessary to offset the higher cost to the state of using taxable bonds and ensure a net return to the state, as suggested by Treasurer Phil Angelides in his letter to Dr. Hall, dated October 26, 2005.
Finally, I believe the provisions requiring licensees to sell resulting therapies to Medi-Cal and other state health care programs at the lowest cost should also apply to county health programs and community clinics since they operate health care safety net programs that serve low-income uninsured patients.
The intellectual property policy the ICOC is on the verge of adopting is very important and will set a precedent that will affect the state for years to come. I look forward to working with the ICOC to advance stem cell research while ensuring that California receives a fair return on its investment in stem cell research, consistent with the intent of Proposition 71 and the promises made during the campaign.
I want to commend the Independent Citizen’s Oversight Committee (ICOC) working group on intellectual property for the progress it has made in developing a proposed policy for handling intellectual property for grants to nonprofit organizations from the California Institute for Regenerative Medicine (CIRM). The proposed policy will help ensure that findings and discoveries developed with Proposition 71 funds In particular, I support and urge the ICOC to adopt the proposed policies requiring grantees to negotiate nonexclusive licenses of CIRM-funded inventions wherever possible, make licensed inventions reasonably accessible for research purposes, and make CIRM-funded patented inventions available at no cost for further research. These policies will ensure that research findings and inventions developed with Proposition 71 funds are freely and openly disseminated among researchers.
I similarly support the proposed requirements that grantees share 25 percent of net royalties received with the state and that they license inventions to organizations that 1) agree to provide resulting therapies to Medi-Cal and other state health care programs at the lowest cost they provide them to other purchasers and 2) have plans for access to the therapies for uninsured patients.
Finally, I agree that CIRM must retain march-in rights in cases where grantees or licensees have not made reasonable efforts to achieve practical application of a CIRM-funded patented invention.
However, I believe it is important that the proposed policies be regarded as a floor for negotiation of intellectual property agreements. I believe the ICOC. I believe this is required by the balancing language of Proposition 71, which clearly states the “ICOC shall establish standards that require that all grants and loan awards be subject to intellectual property agreements that balance the opportunity of the State of California to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials with the need to assure that essential medical research is not unreasonably hindered by the intellectual property agreements.”
The policy also should not preclude the ICOC from requiring a larger share of royalties when necessary to offset the higher cost to the state of using taxable bonds and ensure a net return to the state, as suggested by Treasurer Phil Angelides in his letter to Dr. Hall, dated October 26, 2005.
Finally, I believe the provisions requiring licensees to sell resulting therapies to Medi-Cal and other state health care programs at the lowest cost should also apply to county health programs and community clinics since they operate health care safety net programs that serve low-income uninsured patients.
The intellectual property policy the ICOC is on the verge of adopting is very important and will set a precedent that will affect the state for years to come. I look forward to working with the ICOC to advance stem cell research while ensuring that California receives a fair return on its investment in stem cell research, consistent with the intent of Proposition 71 and the promises made during the campaign.
Sunday, January 29, 2006
CIRM: Moon Shot or Cautionary Tale or Both?
California's stem cell agency took a whack on the opinion page of one newspaper last Friday, but received a mild endorsement from another.
The San Jose Mercury News editorial urged patience, declaring that finding stem cell cures is an even bigger job than sending a man to the moon. It also rejected calls for the resignation of stem cell chairman Robert Klein, although it said he has "been less adept" at running the agency than selling Prop. 71 to voters. The newspaper said, "Californians should expect more bumps along the stem-cell research road in the months and years to come."
Writing on the op-ed page of the San Diego Union-Tribune, Jesse Reynolds of the Center for Genetics and Society had a harsher view. He warned that something akin to the Korean scandal could occur in California, a situation he said the agency has not come to grips with.
Reynolds wrote:
The San Jose Mercury News editorial urged patience, declaring that finding stem cell cures is an even bigger job than sending a man to the moon. It also rejected calls for the resignation of stem cell chairman Robert Klein, although it said he has "been less adept" at running the agency than selling Prop. 71 to voters. The newspaper said, "Californians should expect more bumps along the stem-cell research road in the months and years to come."
Writing on the op-ed page of the San Diego Union-Tribune, Jesse Reynolds of the Center for Genetics and Society had a harsher view. He warned that something akin to the Korean scandal could occur in California, a situation he said the agency has not come to grips with.
Reynolds wrote:
"…California could be in a position to adopt standards, policies and regulatory mechanisms that could serve as a model for the rest of the country – rather than the situation we're in now, in which California's stem cell research is best understood as a cautionary tale.
"On issue after issue, the leadership of California's stem cell research program argue that strong polices standards might sound good, but they will slow the research. But the result is that the program has put moving rapidly over moving responsibly."
New Link Added: Stemcellbattles.com
We are adding another link to this site – this time to a CIRM-related blog by a patient advocate who has monitored the California stem cell agency from the start. The blog is called stemcellbattles.com. The publisher is Don C. Reed, father of Roman Reed, who was paralyzed in a college football accident. Don is a strong supporter of CIRM and vigorously pushed for enactment in 2000 of what came to be known as the Roman Reed Spinal Cord Injury Research Act, which provides California funding for paralysis research. We learned on Friday that the elder Reed used to literally swim with sharks and other lively sea life and has the scars to prove it. He authored or co-authored several youth-oriented books based on his experiences as a diver at Marine World in Northern California. You can still buy them for about a buck each, he noted, on Amazon.com. The titles include "Sevengill: The Shark and Me," "The Dolphins and Me," "Wild Lion of the Sea" and "Notes from an Underwater Zoo."
If you know of other sites dealing with California stem cell issues, please send a note to djensen@californiastemcellreport.com.
If you know of other sites dealing with California stem cell issues, please send a note to djensen@californiastemcellreport.com.
Correction
In two items concerning stem cell researcher Jose Cibelli and his role on CIRM's Standards Working Group, we incorrectly reported that he had resigned from the group. CIRM's website states, in a footnote, that he has "voluntarily withdrawn from active membership" with the group.
Friday, January 27, 2006
Policy for Removal of Stem Cell Advisers Advances
The California stem cell agency is moving forward with development of a policy on removal of members of its working groups – the panels that make key recommendations on facilities, grants and ethical and research standards.
Ordinarily consideration of such a policy would merit little notice, but it came up shortly after one working group member, stem cell researcher Jose Cibelli, became embroiled in the Korean stem cell scandal. Cibelli has resigned from his post at CIRM and has asked Michigan State University, where he is employed, to investigate his involvement in the Korean affair.
California stem cell chairman Robert Klein said today that the development of the removal policy was underway prior to the Cibelli matter.
According to the policy considered by the Governance Subcommittee, members of working groups may be removed for the following
The full text of the policy can be found here. The Governance Subcommittee did not have a quorum and so could not vote on the policy. It will go to the full Oversight Committee for final consideration.
Ordinarily consideration of such a policy would merit little notice, but it came up shortly after one working group member, stem cell researcher Jose Cibelli, became embroiled in the Korean stem cell scandal. Cibelli has resigned from his post at CIRM and has asked Michigan State University, where he is employed, to investigate his involvement in the Korean affair.
California stem cell chairman Robert Klein said today that the development of the removal policy was underway prior to the Cibelli matter.
According to the policy considered by the Governance Subcommittee, members of working groups may be removed for the following
"1. An intentional violation or violations of the Working Group conflict of interest policy applicable to the member;
"2. Two or more grossly negligent violations of the Working Group conflict of interest policy applicable to the member;
"3. Consistent failure to perform the assigned duties of the Working Group member or unexcused absence from three consecutive Working Group meetings;
"4. Violation of medical or ethical standards by the member in his or her professional capacity as determined by the appropriate research institution or the appropriate professional group;
"5. In the case of a member of the Medical Research Funding Working Group, employment by an institution located in the State of California;
"6. In the case of a member of the Medical Facilities Working Group, acceptance of a contract in his or her professional capacity that would create a conflict of interest under Proposition 71 and that cannot be avoided through the procedures and policies preventing actual conflict of interest at the Working Group;
"7. The conviction of a felony or act involving serious moral turpitude."
The full text of the policy can be found here. The Governance Subcommittee did not have a quorum and so could not vote on the policy. It will go to the full Oversight Committee for final consideration.
CIRM Hires Sacramento Lobbyist for Another Three Months
The California stem cell agency has re-engaged a top Sacramento lobbyist to watch over its interests in the Capitol, where legislation is being considered that would have a major impact on its operations.
The contract with Nielsen, Merksamer, Parrinello, Mueller & Naylor was reported to the agency's Governance Subcommittee at a meeting this morning. The firm will be paid $7,500 a month for three months – with a one month extension – beginning Jan. 23.
Last year's contract (first reported by this blog) with the same firm stirred something of a flap, partly for the way it was handled and partly because it is unusual for a state agency to hire a private lobbyist. Virtually all major state agencies have internal lobbyists, which are euphemistically called "legislative units" or some other term.
While one can argue about the cost of the private lobbyist, CIRM needs to have an effective voice in the Capitol, both to communicate with legislators but also to advise the agency about navigating the legislative corridors. If CIRM had an effective lobbyist in place 12 months ago, it would have saved itself a lot of anguish. And it probably would have led to better policy from the beginning.
CIRM would be better served, however, if it could handle its legislative relations without a private lobbyist, but that is not likely to happen until its financial situation improves.
During today's meeting, Oversight Committee member Claire Pomeroy, dean of the UC Davis Medical School, said that communication between CIRM and the legislature "needs to be a high priority." But she also asked, "How are we going to monitor what we are getting for our money."
Stem cell chairman Robert Klein said he would ask Nielsen Merksamer for regular reports on its activities.
CIRM staff also reported that it has requested proposals from five accounting firms for an audit of the agency, as required by law. The audit is budgeted for $50,000. The agency is paying another $45,000 to the State Department of Justice in connection with the litigation against CIRM. And more is expected to be needed.
Here is a link to the agenda item involving the contracts and a summary of all contracts.
The contract with Nielsen, Merksamer, Parrinello, Mueller & Naylor was reported to the agency's Governance Subcommittee at a meeting this morning. The firm will be paid $7,500 a month for three months – with a one month extension – beginning Jan. 23.
Last year's contract (first reported by this blog) with the same firm stirred something of a flap, partly for the way it was handled and partly because it is unusual for a state agency to hire a private lobbyist. Virtually all major state agencies have internal lobbyists, which are euphemistically called "legislative units" or some other term.
While one can argue about the cost of the private lobbyist, CIRM needs to have an effective voice in the Capitol, both to communicate with legislators but also to advise the agency about navigating the legislative corridors. If CIRM had an effective lobbyist in place 12 months ago, it would have saved itself a lot of anguish. And it probably would have led to better policy from the beginning.
CIRM would be better served, however, if it could handle its legislative relations without a private lobbyist, but that is not likely to happen until its financial situation improves.
During today's meeting, Oversight Committee member Claire Pomeroy, dean of the UC Davis Medical School, said that communication between CIRM and the legislature "needs to be a high priority." But she also asked, "How are we going to monitor what we are getting for our money."
Stem cell chairman Robert Klein said he would ask Nielsen Merksamer for regular reports on its activities.
CIRM staff also reported that it has requested proposals from five accounting firms for an audit of the agency, as required by law. The audit is budgeted for $50,000. The agency is paying another $45,000 to the State Department of Justice in connection with the litigation against CIRM. And more is expected to be needed.
Here is a link to the agenda item involving the contracts and a summary of all contracts.
Thursday, January 26, 2006
CIRM Nearing Final Action on Ethics and Research Standards
The California stem cell agency next week will move forward on research and ethical standards that it says will lead the nation in several areas.
According to a press release from CIRM, it will be the first in the nation to:
"legally mandate specialized review by a Stem Cell Research Oversight(SCRO) committee;
"enhance state and federal policies in the areas of voluntary-informed consent;
"and ensure that women's reproductive needs are protected and
prioritized before the research."
The complex, 10-page draft of regulations is due to be considered at a Los Angeles meeting of the Standards Working Group on Monday and Tuesday. Its recommendations will go to the full Oversight Committee Feb. 10, a meeting that is already scheduled to take up another complex subject, intellectual property.
Whether the draft will satisfy its critics is yet to be determined. One, the Center for Genetics and Society, has raised concerns that the agency is considering a loophole that would allow use of eggs from other countries that have lower standards than California.
The draft rules contain language stating that CIRM-funded research is limited to cells obtained "under the oversight of an IRB (or, in the case of foreign sources, an IRB-equivalent)." It goes on to state that CIRM-funded research requires that "the donation of gametes, blastocysts, somatic cells or tissue occurred without payment beyond reasonable compensation for participation. A determination of reasonable compensation shall be performed in accordance with the policies governing the institution involved in derivation activities."
Prop. 71 forbids payments to egg donors in California, but it allows for reimbursement of expenses. Just how those expenses are defined has been debated extensively by the working group. The working draft contains the following definition: "necessary and reasonable costs directly incurred or expended as a result of donation or participation in research activities." A footnote on page 6 adds that expenses "is not used here to allow for differences…that may exist in outside (non-CIRM funded) institutions."
It was not clear from the draft whether the "necessary and reasonable expenses" rule would entitle a woman to be reimbursed for the hiring of a $500-an-hour lawyer/consultant to help her during many hours of wading through the complex informed consent documents and procedures. That hourly figure may sound high to some, but many lawyers, including those who work for CIRM, regularly charge such fees.
The draft does require development of procedures to ascertain whether a donor fully understands "the essential aspects of the research."
The standards group has held eight meetings around California to develop the documents scheduled to be discussed Monday. You can find links to all the proceedings here. Monday's agenda with several background documents is posted here.
The meeting cannot be heard at any offsite locations, but only at the Luxe Hotel in Los Angeles. That is unfortunate, given the important nature of its deliberations. It is the policy of CIRM not to make meetings of the Oversight Committee and its Working Groups, the most important entities within the agency, available to the public beyond their physical locations. Cost was cited as a reason by one official.
According to a press release from CIRM, it will be the first in the nation to:
"legally mandate specialized review by a Stem Cell Research Oversight(SCRO) committee;
"enhance state and federal policies in the areas of voluntary-informed consent;
"and ensure that women's reproductive needs are protected and
prioritized before the research."
The complex, 10-page draft of regulations is due to be considered at a Los Angeles meeting of the Standards Working Group on Monday and Tuesday. Its recommendations will go to the full Oversight Committee Feb. 10, a meeting that is already scheduled to take up another complex subject, intellectual property.
Whether the draft will satisfy its critics is yet to be determined. One, the Center for Genetics and Society, has raised concerns that the agency is considering a loophole that would allow use of eggs from other countries that have lower standards than California.
The draft rules contain language stating that CIRM-funded research is limited to cells obtained "under the oversight of an IRB (or, in the case of foreign sources, an IRB-equivalent)." It goes on to state that CIRM-funded research requires that "the donation of gametes, blastocysts, somatic cells or tissue occurred without payment beyond reasonable compensation for participation. A determination of reasonable compensation shall be performed in accordance with the policies governing the institution involved in derivation activities."
Prop. 71 forbids payments to egg donors in California, but it allows for reimbursement of expenses. Just how those expenses are defined has been debated extensively by the working group. The working draft contains the following definition: "necessary and reasonable costs directly incurred or expended as a result of donation or participation in research activities." A footnote on page 6 adds that expenses "is not used here to allow for differences…that may exist in outside (non-CIRM funded) institutions."
It was not clear from the draft whether the "necessary and reasonable expenses" rule would entitle a woman to be reimbursed for the hiring of a $500-an-hour lawyer/consultant to help her during many hours of wading through the complex informed consent documents and procedures. That hourly figure may sound high to some, but many lawyers, including those who work for CIRM, regularly charge such fees.
The draft does require development of procedures to ascertain whether a donor fully understands "the essential aspects of the research."
The standards group has held eight meetings around California to develop the documents scheduled to be discussed Monday. You can find links to all the proceedings here. Monday's agenda with several background documents is posted here.
The meeting cannot be heard at any offsite locations, but only at the Luxe Hotel in Los Angeles. That is unfortunate, given the important nature of its deliberations. It is the policy of CIRM not to make meetings of the Oversight Committee and its Working Groups, the most important entities within the agency, available to the public beyond their physical locations. Cost was cited as a reason by one official.
Wednesday, January 25, 2006
The Stem Cell Agenda of a State Senator
What does Deborah want? It is a question that floats around in the minds of some folks at California's stem cell agency.
Deborah is Sen. Deborah Ortiz, D-Sacramento, chair of the state Senate Health Committee and the legislative mover-and-shaker on stem cell issues. She is carrying a proposed constitutional amendment that would tighten oversight of CIRM and guarantee benefits to California from CIRM-funded research. She also plans to re-introduce a bill designed to protect women who donate their eggs for stem cell research.
She laid out her agenda clearly in a speech Monday that received no media attention. But her comments go to the heart of stem cell work in California. The principles behind them – accountability, transparency and disclosure -- additionally go to the heart of stem cell work anywhere in the world. Here in California, it is important to note that she says it is not necessary to make constitutional changes in CIRM; "binding regulations" would suffice.
In her speech she said Prop. 71 is "light" in the following areas:
Ortiz said she believed the problems were "fixable" and hopes to engage in further dialogue with CIRM on solutions.
Deborah is Sen. Deborah Ortiz, D-Sacramento, chair of the state Senate Health Committee and the legislative mover-and-shaker on stem cell issues. She is carrying a proposed constitutional amendment that would tighten oversight of CIRM and guarantee benefits to California from CIRM-funded research. She also plans to re-introduce a bill designed to protect women who donate their eggs for stem cell research.
She laid out her agenda clearly in a speech Monday that received no media attention. But her comments go to the heart of stem cell work in California. The principles behind them – accountability, transparency and disclosure -- additionally go to the heart of stem cell work anywhere in the world. Here in California, it is important to note that she says it is not necessary to make constitutional changes in CIRM; "binding regulations" would suffice.
In her speech she said Prop. 71 is "light" in the following areas:
"--meaningful conflict of interest standards for the appointees who review and make recommendations for funding,Her legislation would:
"--open meeting and public records requirements to ensure that the public has information about projects that are recommended and not recommended for funding;
"--workable provisions to ensure that taxpayers get a return on their investment in stem cell research, consistent with the promises made to voters.
"--stringent standards to protect women who may consider donating eggs for stem cell research."
"--require members of the Prop. 71 working groups, without exceptions, to disclose their interests in research institutions, biotechnology, and pharmaceutical companies involved with stem cell research;
"--require meetings and deliberations of the Prop. 71 governing body and working groups to be conducted in public, with narrow exceptions for scientific peer review discussions, medical privacy, discussion of proprietary or scientific prepublication information, and personnel matters.
"--require Prop. 71 grantees to agree to share royalties on successful inventions with the state and to require licensees to sell any resulting products or treatments to the state at the best price they provide it to any purchaser.
"--require women considering donating their eggs for research to provide written informed consent and prohibit compensation of egg donors beyond the direct expenses entailed in undergoing egg extraction."
Ortiz said she believed the problems were "fixable" and hopes to engage in further dialogue with CIRM on solutions.
Tuesday, January 24, 2006
Light Coverage of Stem Cell IP Decisions
Three California newspapers carried stories this morning on key decisions involving who benefits economically from the state's $6 billion stem cell research program.
Two of the papers – The Sacramento Bee (reporter Jim Wasserman) and the San Diego Union Tribune (reporter Terri Somers) – led with the news about efforts to provide relatively lost cost therapies to low income and uninsured persons.
The Contra Costa Times (reporter Sandi Kleffman) began with the stem cell agency's plan to share something less than 25 percent of revenues from therapies with the state.
You will find minor differences in some of the details of what the stories reported. That is primarily caused by the loose language of the changes made during yesterday's meeting. Also two of the papers – The Bee and the Union Tribune – covered the session at Stanford remotely through a conference call, which makes it difficult to hear at times.
Speaking of conference calls and apropos of our earlier items on the Carlyle hotel, Sherry Lansing, a member of the CIRM IP task force, checked in from the swank and privacy-oriented Carlyle in New York City. But we don't know whether any members of the public were there. Lansing made a few comments during the meeting that began at 1 p.m. and checked out of the call by about 3 p.m.
No stories were seen on the Web from the San Francisco Chronicle, the hometown newspaper of the stem cell agency, and the Los Angeles Times, California's largest newspaper.
Here are links to The Bee story, Contra Costa Times and the San Diego Union Tribune.
Two of the papers – The Sacramento Bee (reporter Jim Wasserman) and the San Diego Union Tribune (reporter Terri Somers) – led with the news about efforts to provide relatively lost cost therapies to low income and uninsured persons.
The Contra Costa Times (reporter Sandi Kleffman) began with the stem cell agency's plan to share something less than 25 percent of revenues from therapies with the state.
You will find minor differences in some of the details of what the stories reported. That is primarily caused by the loose language of the changes made during yesterday's meeting. Also two of the papers – The Bee and the Union Tribune – covered the session at Stanford remotely through a conference call, which makes it difficult to hear at times.
Speaking of conference calls and apropos of our earlier items on the Carlyle hotel, Sherry Lansing, a member of the CIRM IP task force, checked in from the swank and privacy-oriented Carlyle in New York City. But we don't know whether any members of the public were there. Lansing made a few comments during the meeting that began at 1 p.m. and checked out of the call by about 3 p.m.
No stories were seen on the Web from the San Francisco Chronicle, the hometown newspaper of the stem cell agency, and the Los Angeles Times, California's largest newspaper.
Here are links to The Bee story, Contra Costa Times and the San Diego Union Tribune.
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