Here is the text of the press release by CIRM on Friday's meeting. It was not available on the Web at the time of this posting.
ICOC RATIFIES KEY POLICIES FOR CIRM-FUNDED RESEARCH
Members Unanimously Approve CIRM Regulations and Intellectual Property Policy
STANFORD, Calif.—The Independent Citizens’ Oversight Committee (ICOC) today ratified two key policies for research funded by the California Institute for Regenerative Medicine (CIRM): the CIRM Regulations for ethical, medical and scientific accountability and the Intellectual Property (IP) Policy for Non-Profit Organizations. These policies were recommended by the Standards Working Group and IP Task Force after months of deliberations.
Developed with input from the California public and state legislature, the policies include provisions that enhance and surpass federal and state guidelines for scientific standards and intellectual property.
“These policies are representative of the ICOC’s commitment to ensuring that CIRM-funded research is conducted under the highest levels of public oversight and transparency,” ICOC Chairman Robert Klein said. “The working group and task force members went above and beyond the gold standards recommended by the National Academies to enhance those standards and policies, reflecting the leadership of California in protecting patients and advancing scientific research.”
“The CIRM Regulations and IP Policy provide CIRM with a strong foundation to carry out its mission of funding stem cell research in California,” CIRM President Zach Hall, PhD, said. “With the approval of these policies, CIRM has the most stringent ethical, medical and scientific standards in the country.”
CIRM is now the first agency in the United States to require specialized review by a Stem Cell Research Oversight (SCRO) committee and to provide for medical costs resulting from any immediate complications of egg retrieval. It also enhances state and federal policies in the areas of voluntary-informed consent and guarantees that all cell lines used by CIRM-funded researchers are derived without compensation to egg donors. The regulations were developed under the guidance of the Standards Working Group, which is comprised of nine nationally recognized scientists, four ethicists and five ICOC patient advocates. To view the full text of the regulations online, please visit: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_9.pdf.
The IP Policy for Non-Profit Organizations also sets a high bar for CIRM, surpassing the federal statute on the sharing of data and biomedical materials and allowing California research institutions to freely use all CIRM-funded patented inventions. Written by the 11-member IP Task Force, this subcommittee held four public meetings and twice reported to the ICOC with their findings. The full text of the IP Policy is available at: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_8.pdf.
In developing the CIRM Regulations and IP Policy for Non-Profit Organizations, multiple public hearings and meetings were held throughout California to gather input and incorporate public feedback into the final recommendations. Members of the California State Legislature personally contributed recommendations that included in the final policies.
With the ICOC’s approval, these policies will now enter into the formal rule-making process governed by the Administrative Procedures Act and have the force of California law.
Friday, February 10, 2006
Thursday, February 09, 2006
Cryptic Agenda Not Good Enough
On Wednesday, we discussed the failure of CIRM to meet its commitment to the highest and best standards of transparency and openness. This item will offer more specifics on matters on which CIRM apparently does not want the public to be fully informed.
CIRM will deny that it is trying to keep important issues under wraps, citing staff shortages and other difficulties. But the fact is that if the agency had the will, it could make the information available. It has hired a nationally known PR agency, but none of those considerable resources seem to have been applied in the most fundamental of all PR efforts. And that is to provide the basic information about what CIRM is doing and why.
We have acknowledged CIRM has done a better job concerning the IP and research standards policies, although given their far-reaching implications, it would have been better to have seen the latest drafts posted a week earlier. They are the heart of the Oversight Committee's agenda on Friday.
Those two draft policy postings on the Web, however, are exceptions to the general obliviousness of CIRM to the need to inform the public well in advance about the issues it is considering. That means explanation and context online, not just cryptic one-line agenda items.
For the record, here are the cryptic agenda items. They are from the CIRM website less than 12 hours before the meeting at which they are going to be considered. If you would like to comment before the Oversight Committee, good luck.
Failure in Public Responsibility: Feb. 9th's Roll Call
(Items – quoted verbatim – from the Oversight Committee agenda on Friday that offer no explanation, justification or details.)
"Consideration of naming opportunity for CIRM training grant program." (Our comment: This may involve the sale of the naming rights to the program, as the naming of sports arenas are sold to such companies as Staples.)
"Informational report on plan/process for development of Scientific Strategic Plan."(Our comment: This involves important issues concerning priorities of the patient advocates vs. the pure research folks on the Oversight Committee.)
"Consideration of scientific meeting: Assessing the Medical Risks of Human Oocyte Donation" (Our comment: This is likely to involve significant expenditures, not to mention the important nature of the topic.)
"Consideration of joint venture with Public Library of Science and New York City Stem Cell Research Foundation."(Our comment: This may be some sort of open access arrangement, which could have national implications.)
"Chairman’s Report" and "President’s Report" (Our comment: These usually contain significant information, including Power Point presentations prepared in advance. But on at least one occasion the president of CIRM was surprised by a significant proposal in the chairman's report.)
CIRM will deny that it is trying to keep important issues under wraps, citing staff shortages and other difficulties. But the fact is that if the agency had the will, it could make the information available. It has hired a nationally known PR agency, but none of those considerable resources seem to have been applied in the most fundamental of all PR efforts. And that is to provide the basic information about what CIRM is doing and why.
We have acknowledged CIRM has done a better job concerning the IP and research standards policies, although given their far-reaching implications, it would have been better to have seen the latest drafts posted a week earlier. They are the heart of the Oversight Committee's agenda on Friday.
Those two draft policy postings on the Web, however, are exceptions to the general obliviousness of CIRM to the need to inform the public well in advance about the issues it is considering. That means explanation and context online, not just cryptic one-line agenda items.
For the record, here are the cryptic agenda items. They are from the CIRM website less than 12 hours before the meeting at which they are going to be considered. If you would like to comment before the Oversight Committee, good luck.
Failure in Public Responsibility: Feb. 9th's Roll Call
(Items – quoted verbatim – from the Oversight Committee agenda on Friday that offer no explanation, justification or details.)
"Consideration of naming opportunity for CIRM training grant program." (Our comment: This may involve the sale of the naming rights to the program, as the naming of sports arenas are sold to such companies as Staples.)
"Informational report on plan/process for development of Scientific Strategic Plan."(Our comment: This involves important issues concerning priorities of the patient advocates vs. the pure research folks on the Oversight Committee.)
"Consideration of scientific meeting: Assessing the Medical Risks of Human Oocyte Donation" (Our comment: This is likely to involve significant expenditures, not to mention the important nature of the topic.)
"Consideration of joint venture with Public Library of Science and New York City Stem Cell Research Foundation."(Our comment: This may be some sort of open access arrangement, which could have national implications.)
"Chairman’s Report" and "President’s Report" (Our comment: These usually contain significant information, including Power Point presentations prepared in advance. But on at least one occasion the president of CIRM was surprised by a significant proposal in the chairman's report.)
Wednesday, February 08, 2006
Does CIRM Have a "Secret" Proposal on Openness?
We are sad to report, once again, the failure of the California stem cell agency to comply with its own promise of the highest standards of openness and transparency.
We have written repeatedly about the failure of CIRM to provide adequate background material in a timely fashion on the important matters on its agenda. Even some of its own directors have complained publicly.
The most recent example is Friday's meeting of the Oversight Committee. For example if you care about open access to CIRM-funded findings, you would be hard pressed to determine whether that is a subject to be considered at the session -- aside from the IP draft rules.
But apparently it is. There is a brief mention on the agenda of a proposed venture with the Public Library of Science. If you dig into that enterprise, it is all about making scientific findings widely available. Why isn't there additional information available from CIRM about the venture? There is a bit of irony in all this – an apparent openness proposal that is basically being advanced in secret.
Is CIRM going to sell naming rights to its stem cell scholar program? In other words, are we going to have something known as the World Savings Stem Cell Scholar Program. The quid pro quo may be purchase of CIRM bond anticipation notes. Maybe that is on the agenda(item 13) as well. It is impossible to tell from the document online. But we heard stem cell chairman Robert Klein broach the idea in September at a meeting of the Oversight Committee.
More details may be posted on these matters as the day progresses on Thursday. But most interested parties, if they wish to make their views known, cannot simply abandon all other plans on a one-day or less notice to appear at Friday's Oversight Committee meeting.
That said, we should give credit to CIRM for posting the IP policy and research standards earlier this week. In the case of IP, it was on Saturday. An excellent example to be emulated for all agenda items.
We have written repeatedly about the failure of CIRM to provide adequate background material in a timely fashion on the important matters on its agenda. Even some of its own directors have complained publicly.
The most recent example is Friday's meeting of the Oversight Committee. For example if you care about open access to CIRM-funded findings, you would be hard pressed to determine whether that is a subject to be considered at the session -- aside from the IP draft rules.
But apparently it is. There is a brief mention on the agenda of a proposed venture with the Public Library of Science. If you dig into that enterprise, it is all about making scientific findings widely available. Why isn't there additional information available from CIRM about the venture? There is a bit of irony in all this – an apparent openness proposal that is basically being advanced in secret.
Is CIRM going to sell naming rights to its stem cell scholar program? In other words, are we going to have something known as the World Savings Stem Cell Scholar Program. The quid pro quo may be purchase of CIRM bond anticipation notes. Maybe that is on the agenda(item 13) as well. It is impossible to tell from the document online. But we heard stem cell chairman Robert Klein broach the idea in September at a meeting of the Oversight Committee.
More details may be posted on these matters as the day progresses on Thursday. But most interested parties, if they wish to make their views known, cannot simply abandon all other plans on a one-day or less notice to appear at Friday's Oversight Committee meeting.
That said, we should give credit to CIRM for posting the IP policy and research standards earlier this week. In the case of IP, it was on Saturday. An excellent example to be emulated for all agenda items.
Disclosure From the California Stem Cell Report
As many of you have noticed, the information about how this blog is produced states that it is written from a sailboat on the west coast of Mexico. For the record, we do make occasional trips back to the Old Country. Most recently, we have been in California since the beginning of December for a variety of reasons, including the birth of a grandson in Santa Barbara on the Winter Solstice (also the date of the biggest surf of year) and the remodel of our daughter's home in San Mateo. She is an active taskmaster. We have worked as a day laborer, electrician, child care provider, cook, personal shopper, project consultant and handholder under her direction. The same can be said for our son, the surfer, who was tending to birthing matters instead of breaking waves on the day of his child's arrival. We have had the opportunity to demonstrate plumbing, carpentry, gardening and solar power skills at his home, in addition to dealing with the usual conundrums of newborns and parents with their first child. These are not novel experiences, we might add, as any grandparent can attest. We salute them all.
What that means for this blog is that we have attended some CIRM meetings, toured the headquarters and discussed matters with both the agency staff and the regular observers, critics and supporters of CIRM. A visit late last summer also permitted such indulgences. On the other hand, that does mean we snatched precious time away from grandchildren, not to mention their parents, who are nearing the dreaded age of 40.
But on the issue of disclosure, we want to let our readers know that we have no investments in biotech firms or any other organizations that could benefit from stem cell research, except through mutual funds, which, of course, we have no control over. We do not hold any mutual funds that are industry specific to biotech.
Beyond that, we are not employed nor do we receive funds from any organization involved in biotech or stem cell activities. Nor is any member of our immediate family (meaning wife and children) involved in such a fashion. As far as we know, no distant relations are involved in biotech or have investments in that area.
We also have no financial connections with organizations critical or opposed to CIRM.
One would hope that reporters, observers or anybody trying to influence CIRM (which is not the same as reporters) would be willing to make the same sort of economic disclosure as above. By that we mean specific dollar amounts, from $1 (one dollar) and up – not those wimpy disclosures required under state law or by CIRM.
Beyond the economics, the California Stem Cell Report supports embryonic stem cell research. And we believe that CIRM is pursuing a worthwhile endeavor, albeit in a somewhat imperfect manner. We also believe that openness, transparency and disclosure are fundamental to good government. That means providing background agenda material well ahead of meeting dates, among other things. Otherwise, meetings can amount to nothing more than sneak-through business, plenty of which can be seen in Congress and the California Legislature.
We also believe in maximum disclosure; when it doubt lay it out. Specifically all significant persons within CIRM, including members of CIRM working groups, should publicly disclose their economic interests in more detail than required by state law.
If you have any further questions about our basic assumptions or potential conflicts, please send an email to djensen@californiastemcellreport.com or use the "comment" function at the end of this item.
What that means for this blog is that we have attended some CIRM meetings, toured the headquarters and discussed matters with both the agency staff and the regular observers, critics and supporters of CIRM. A visit late last summer also permitted such indulgences. On the other hand, that does mean we snatched precious time away from grandchildren, not to mention their parents, who are nearing the dreaded age of 40.
But on the issue of disclosure, we want to let our readers know that we have no investments in biotech firms or any other organizations that could benefit from stem cell research, except through mutual funds, which, of course, we have no control over. We do not hold any mutual funds that are industry specific to biotech.
Beyond that, we are not employed nor do we receive funds from any organization involved in biotech or stem cell activities. Nor is any member of our immediate family (meaning wife and children) involved in such a fashion. As far as we know, no distant relations are involved in biotech or have investments in that area.
We also have no financial connections with organizations critical or opposed to CIRM.
One would hope that reporters, observers or anybody trying to influence CIRM (which is not the same as reporters) would be willing to make the same sort of economic disclosure as above. By that we mean specific dollar amounts, from $1 (one dollar) and up – not those wimpy disclosures required under state law or by CIRM.
Beyond the economics, the California Stem Cell Report supports embryonic stem cell research. And we believe that CIRM is pursuing a worthwhile endeavor, albeit in a somewhat imperfect manner. We also believe that openness, transparency and disclosure are fundamental to good government. That means providing background agenda material well ahead of meeting dates, among other things. Otherwise, meetings can amount to nothing more than sneak-through business, plenty of which can be seen in Congress and the California Legislature.
We also believe in maximum disclosure; when it doubt lay it out. Specifically all significant persons within CIRM, including members of CIRM working groups, should publicly disclose their economic interests in more detail than required by state law.
If you have any further questions about our basic assumptions or potential conflicts, please send an email to djensen@californiastemcellreport.com or use the "comment" function at the end of this item.
Tuesday, February 07, 2006
Are Women Ready to Donate Their Eggs for 'Nothing?'
Ready to dig into the question of whether women should be allowed to sell their eggs or, put another way, how much should they be allowed to receive?
The latest version of proposed CIRM rules dealing with such questions is now available online for your reading pleasure. Basically CIRM is ready to answer that if women want to sell their eggs, none of its researchers are buying. And it wants to put limits on what the women can receive – no more than expenses, including lost wages. Of course, women who want to sell their eggs can go elsewhere, where CIRM standards are not applicable.
But what CIRM decides at the meeting of its Oversight Committee on Friday is likely to establish a national model for stem cell research standards. As CIRM points out in a press release, the rules would make CIRM the first agency in the country to:
The latest version of proposed CIRM rules dealing with such questions is now available online for your reading pleasure. Basically CIRM is ready to answer that if women want to sell their eggs, none of its researchers are buying. And it wants to put limits on what the women can receive – no more than expenses, including lost wages. Of course, women who want to sell their eggs can go elsewhere, where CIRM standards are not applicable.
But what CIRM decides at the meeting of its Oversight Committee on Friday is likely to establish a national model for stem cell research standards. As CIRM points out in a press release, the rules would make CIRM the first agency in the country 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;
"protect health of women donating eggs for research;
"guarantee that all cell lines used by CIRM-funded researchers are
derived without compensation to egg donors."
It is impossible to cover all eventualities when drafting such ethical standards. It is also impossible to stop all persons determined to violate ethical codes or the law, but some questions appear to remain in the draft.
One involves the use of eggs from distant sources. It is relatively easy to check out procedures used by egg providers in the United States. This country has a relatively uniform ethical approach in science, although there are always a few rogues. But distant locations such as Thailand, which already is notorious for its sex industry, are harder to assess. To what lengths are California researchers going to go to ascertain whether an egg supplier in Thailand has similar informed consent procedures to those here? How will payments to foreign donors be evaluated? "Necessary and reasonable costs directly incurred" could mean something far different in another culture than in California.
The proposed rules put much of the burden of answering these questions on the recipients of the grants, both the individual and institutions. How well the standards will be applied will depend, in many ways, on the rigor of the recipients. CIRM proposes penalties for failure to comply. Of course, if problems arise, the ethical standards can be strengthened.
The proposed rules additionally require that unspecified "steps shall be taken to enhance the informed consent process. " They require the researcher to ascertain that the donor understands the "essential aspects of the research." Couple that with reimbursement of donor expenses, it could lead to the hiring of expensive consultants for donors or creation of costly donor education conferences, both of which could be deemed a reimbursable expense. Such activities may well be appropriate but they do open the door to potential abuse. Again the recipients and their institutions will play a critical role in regulating activities. They are likely to want to play it safe in terms of ensuring informed consent, both to comply with CIRM rules and ward off potential lawsuits. That comes at a price. Not to mention the possibility of kickbacks by unprincipled consultants to donors who hire them.
Again, these are difficult issues to address, and any set of rules can be circumvented or abused. Oversight of the ethics standards should be a top priority for the CIRM.
While we are on the subject of standards, reporter Dan Levine of the San Francisco Business Times put together a good overview of many of the issues involved.
Levine quotes David Magnus, director of the Stanford Center for Biomedical Ethics, as saying, "If Massachusetts decides they are going to allow payment of egg donors, and California decides they aren't, then we won't be able to share cell lines derived from one state to another. Whatever policies wind up getting put in place for this kind of an issue, it's really important that everybody be on the same page and have the same policies."
Levine also quotes Ronald Green, director of the Ethics Institute at Dartmouth College and chair of the ethics advisory board of Advanced Cell Technology, as saying, Our experience is that they (women) are not willing to step forward and donate eggs for nothing. It is not enjoyable to be injected with powerful drugs that alter your mood and hurt you, and the whole process and potential for organ failure, all culminating in a transvaginal needle harvest through the back wall of the vagina. How many women are going to do that to assist research to understand diabetes?"
Free Parking for Friday CIRM Meeting
Free parking is available for Friday's meeting of the Oversight Committee at Stanford University. The parking area is located in Galvez Field Parking & Frances C. Arrillaga Alumni Center, according to CIRM. For directions, see: http://forum.stanford.edu/visit/directions/arrillaga.
Bad Link on IP Policy
A reader reports there was a bad link to the IP draft to be considered at Friday's meeting. Thanks to the reader for pointing it out. It has been fixed. Here it is for those who need it right now: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_8.pdf
Monday, February 06, 2006
CIRM and the $40 Million Matter
God and the Main Stream Media – they both move in mysterious ways.
The case in point is whether the California stem cell agency is broke. Lawsuits have prevented it from issuing the bonds that were designed to fund it. So the agency has been living on the dole with loans and handouts, although that is a less than a positive way to describe the $5 million the Dolby Foundation gave to CIRM.
Last month reporter Marisa Lagos of the San Francisco Examiner reported that the agency had raised $40 million, basically solving its financial crisis. That is a big story. On a slow day, it might even be front page news for many California newspapers -- properly told.
Lagos' Jan. 17 report was based on a speech by stem cell chairman Robert Klein that none of the Main Stream Media covered. In covering that speech, she was following some of the basic rules for good reporting – be on the scene, cover the principal, don't assume. She deserves considerable credit for even knowing about the speech. It was not publicized by CIRM and did not surface in advance with any of the usual Web search engines. So why has her report been widely ignored?
For those of you who do not keep up with the twists of the newspaper business, the Examiner is a shell of its former self. It has found itself in a situation where it cannot charge for circulation and is distributed free, including home delivery, in some San Francisco area communities.
That means that other newspapers with paid circulation do not pay much attention to it. They sniff at a story in a free newspaper, weekly or daily as is the Examiner. So the Main Steam Media do not try to match stories in these ragtag rags even when they enjoy greater economic success than the conventional dailies, which many of them do.
The California Stem Cell Report (this thing that you are reading) did confirm that CIRM has raised $40 million. But what may be more interesting is that the figure has now been reported in the Main Stream Media. Say what you will, having information published in a newspaper is still more important than having it published on the Web. It probably has to do with the smell of the ink, but if you want to know more, send me an email and I will explain.
Reporter Terri Somers of the San Diego Union-Tribune, which is very definitely Main Stream Media, reported the $40 million figure once more in a story during the weekend. She said that Klein, at an appearance Friday at the Stem Cell Research Center at the Burnham Institute for Medical Research in La Jolla, basically confirmed the amount. Somers deserves kudos for pursuing the $40 million matter, which all of the other major newspapers in California have ignored.
The mysteries of the Main Stream Media are deep and complex. In discussing coverage of the $40 million matter, we have touched on only a sidelight of the media's arcane and byzantine world. Next week we tackle God.
The case in point is whether the California stem cell agency is broke. Lawsuits have prevented it from issuing the bonds that were designed to fund it. So the agency has been living on the dole with loans and handouts, although that is a less than a positive way to describe the $5 million the Dolby Foundation gave to CIRM.
Last month reporter Marisa Lagos of the San Francisco Examiner reported that the agency had raised $40 million, basically solving its financial crisis. That is a big story. On a slow day, it might even be front page news for many California newspapers -- properly told.
Lagos' Jan. 17 report was based on a speech by stem cell chairman Robert Klein that none of the Main Stream Media covered. In covering that speech, she was following some of the basic rules for good reporting – be on the scene, cover the principal, don't assume. She deserves considerable credit for even knowing about the speech. It was not publicized by CIRM and did not surface in advance with any of the usual Web search engines. So why has her report been widely ignored?
For those of you who do not keep up with the twists of the newspaper business, the Examiner is a shell of its former self. It has found itself in a situation where it cannot charge for circulation and is distributed free, including home delivery, in some San Francisco area communities.
That means that other newspapers with paid circulation do not pay much attention to it. They sniff at a story in a free newspaper, weekly or daily as is the Examiner. So the Main Steam Media do not try to match stories in these ragtag rags even when they enjoy greater economic success than the conventional dailies, which many of them do.
The California Stem Cell Report (this thing that you are reading) did confirm that CIRM has raised $40 million. But what may be more interesting is that the figure has now been reported in the Main Stream Media. Say what you will, having information published in a newspaper is still more important than having it published on the Web. It probably has to do with the smell of the ink, but if you want to know more, send me an email and I will explain.
Reporter Terri Somers of the San Diego Union-Tribune, which is very definitely Main Stream Media, reported the $40 million figure once more in a story during the weekend. She said that Klein, at an appearance Friday at the Stem Cell Research Center at the Burnham Institute for Medical Research in La Jolla, basically confirmed the amount. Somers deserves kudos for pursuing the $40 million matter, which all of the other major newspapers in California have ignored.
The mysteries of the Main Stream Media are deep and complex. In discussing coverage of the $40 million matter, we have touched on only a sidelight of the media's arcane and byzantine world. Next week we tackle God.
Latest Version of Stem Cell IP Policy Ready
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.
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.
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.
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