The agenda for the Oct. 10 and 11 meetings of the Oversight Committee for the California stem cell agency is now available on CIRM's web site with the draft of the strategic plan expected on Wednesday.
As usual, the sessions are fully packed. Much of the background material is not yet available, but the agency seems to be doing a better job of posting the material earlier.
We make that comment after being obliquely chastized on Monday by one CIRM staffer for failing to note when the agency improves its performance. Point taken.
Scheduled to be posted on the CIRM web site on Wednesday is a rather hefty document – the draft of the strategic plan for the agency. We are told it is in the range of 90 to 100 pages, so plan on curling up in the front of the fire for a good read.
If you want to influence CIRM's spending plans, now is the time to weigh in. The plan comes up for discussion at the meetings next week. It is scheduled to be approved at the Oversight Committee in December.
Tuesday, October 03, 2006
Sunday, October 01, 2006
Whittling Down the Researchers: The 'Unhappy' Result of Stem Cell Enthusiasm
The California stem cell agency faces a nearly overwhelming task in the wake of notices from about 350 scientists, saying they intend to apply for about $100 million in grants over the next few months.
The agency has already moved to whittle down the number of potential applicants by requiring the institutions involved to certify that the letters of intent were filed by principal investigators. One veteran stem cell scientist, who is not affected by the certification call, said the requirement has left "fair numbers of angry and anxious people."
The certification will elminate some, perhaps many applications from less senior scientists, despite CIRM's intention to encourage younger researchers.
The requirement for a letter of certification was not mentioned in the initial instructions for the letters of intent. The certification form that was posted on CIRM's web site was created on Sept. 19, four days after the deadline for the letters of intent.
In response to a series of questions from the California Stem Cell Report, Dale Carlson, chief communications officer for CIRM, said,
The scientist who discussed this issue with the California Stem Cell Report asked not to be named for a number of reasons. We understand that position. For us, it is enough to say that CIRM plays a vast role in the funding of research, and no prospective applicants are likely to want to appear to be grousing about its conduct. Anonymity of sources, however, always raises a flag. In this case, the individual we spoke with is well respected in the field and has had considerable experience with grant reviews, conducting them for the NIH.
Here is what we learned during our discussions, which dealt primarily with the SEED grants, which attracted 280 scientists. CIRM says the grants, which are scheduled to be voted on by the Oversight Committee in February, are aimed at bringing in "new ideas and new investigators."
Many of the scientists who filed letters of intent will be disappointed, we were told. Many aren't qualified under the terms of the certification. A good part of the problem is the classification of reseach scientists at many institutions as non-faculty. Instead they carry titles such as research professional or staff scientist. The letter of certification asks institutions to certify that an applicant holds a "faculty-level position," among other things.
The fundamental problem is the size of the potential applicant pool. The scientist compared it to an NIH experience in which the number of applications was far smaller but the number of reviewers much, much larger. Even if the number of CIRM grant applications is reduced by half, it is still too large for the 15 scientific grant reviewers.
We asked CIRM about the workload, assuming ultimately 200 applications with about two hours spent on each grant by each of CIRM's scientific reviewers. By law, as we understand it, each reviewer in the CIRM grants program must examine each application. That amounts to 400 hours or 10 "normal" work weeks for each scientist, who already has a full plate with his or her own work. Is that a reasonable estimate, we asked CIRM last Monday. If not what is? We have not yet had a response on that matter and others, such as whether it is fair to impose what appears to be a requirement that was not laid out in the original request for letters. We have indications that a response may be coming at some point. We will carry it when it arrives.
The scientist we talked to did not have a solution to the workload issue or how to fairly screen out some of those who filed letters of intent. But it is clear that fixing the number of reviewers in state law is a limiting factor, to put it mildly. It would be useful to be able to revise such minutia without going to a vote of the people, which is what is currently required for a change.
CIRM reviewers are all from out-of-state and cannot apply for CIRM grants. Although reviewers can learn from the reviewing process, our scientist said that it is a "great burden" to be a grant reviewer, either for CIRM or the NIH. Most do it out of an "irrational sense of altruism."
Let us know about what you think about this issue. Click on the word "comments" below to express your opinion. It can be done anonymously. Google, which hosts this blog, has set up anonymous comments in such a fashion that not even we can determine the names of those who use the "anonymous" feature.
Here is a link to the certification form and the application instructions.
The agency has already moved to whittle down the number of potential applicants by requiring the institutions involved to certify that the letters of intent were filed by principal investigators. One veteran stem cell scientist, who is not affected by the certification call, said the requirement has left "fair numbers of angry and anxious people."
The certification will elminate some, perhaps many applications from less senior scientists, despite CIRM's intention to encourage younger researchers.
The requirement for a letter of certification was not mentioned in the initial instructions for the letters of intent. The certification form that was posted on CIRM's web site was created on Sept. 19, four days after the deadline for the letters of intent.
In response to a series of questions from the California Stem Cell Report, Dale Carlson, chief communications officer for CIRM, said,
"The certification form was promulgated after the LOIs(letters of intent) came in, to clarify the qualifications necessary to apply for either grant (PI must be an independent investigator, full-time, on-site, etc.). It may eliminate some full applications from some who filed LOIs but aren't qualified for grants. It's common to require written confirmation of portions of a grant application. I haven't heard of any complaints."However, it is clear that some folks are disappointed and feel as if the rules were changed in the middle of the game.
The scientist who discussed this issue with the California Stem Cell Report asked not to be named for a number of reasons. We understand that position. For us, it is enough to say that CIRM plays a vast role in the funding of research, and no prospective applicants are likely to want to appear to be grousing about its conduct. Anonymity of sources, however, always raises a flag. In this case, the individual we spoke with is well respected in the field and has had considerable experience with grant reviews, conducting them for the NIH.
Here is what we learned during our discussions, which dealt primarily with the SEED grants, which attracted 280 scientists. CIRM says the grants, which are scheduled to be voted on by the Oversight Committee in February, are aimed at bringing in "new ideas and new investigators."
Many of the scientists who filed letters of intent will be disappointed, we were told. Many aren't qualified under the terms of the certification. A good part of the problem is the classification of reseach scientists at many institutions as non-faculty. Instead they carry titles such as research professional or staff scientist. The letter of certification asks institutions to certify that an applicant holds a "faculty-level position," among other things.
The fundamental problem is the size of the potential applicant pool. The scientist compared it to an NIH experience in which the number of applications was far smaller but the number of reviewers much, much larger. Even if the number of CIRM grant applications is reduced by half, it is still too large for the 15 scientific grant reviewers.
We asked CIRM about the workload, assuming ultimately 200 applications with about two hours spent on each grant by each of CIRM's scientific reviewers. By law, as we understand it, each reviewer in the CIRM grants program must examine each application. That amounts to 400 hours or 10 "normal" work weeks for each scientist, who already has a full plate with his or her own work. Is that a reasonable estimate, we asked CIRM last Monday. If not what is? We have not yet had a response on that matter and others, such as whether it is fair to impose what appears to be a requirement that was not laid out in the original request for letters. We have indications that a response may be coming at some point. We will carry it when it arrives.
The scientist we talked to did not have a solution to the workload issue or how to fairly screen out some of those who filed letters of intent. But it is clear that fixing the number of reviewers in state law is a limiting factor, to put it mildly. It would be useful to be able to revise such minutia without going to a vote of the people, which is what is currently required for a change.
CIRM reviewers are all from out-of-state and cannot apply for CIRM grants. Although reviewers can learn from the reviewing process, our scientist said that it is a "great burden" to be a grant reviewer, either for CIRM or the NIH. Most do it out of an "irrational sense of altruism."
Let us know about what you think about this issue. Click on the word "comments" below to express your opinion. It can be done anonymously. Google, which hosts this blog, has set up anonymous comments in such a fashion that not even we can determine the names of those who use the "anonymous" feature.
Here is a link to the certification form and the application instructions.
Wisconsin Rachets Up Its Stem Cell Pitch
Like Arnold Schwarzenegger, Wisconsin Gov. Jim Doyle is in a re-election campaign. And like Arnold, Jim is courting the stem cell vote.
Last week Doyle announced that Wisconsin is not going to take the Golden State's $3 billion stem cell research program lying down.
He announced that Wisconsin Alumni Research Foundation (WARF) "will offer free, non-exclusive licenses to conduct embryonic stem cell research to companies that are sponsoring such research at Wisconsin non-profit and academic institutions," according to a story by reporter Kathleen Gallagher of the Milwaukee Journal Sentinel.
Reporter Anita Weier wrote in the Wisconsin State Journal:
Reacting to Doyle's move, he said,
Last week Doyle announced that Wisconsin is not going to take the Golden State's $3 billion stem cell research program lying down.
He announced that Wisconsin Alumni Research Foundation (WARF) "will offer free, non-exclusive licenses to conduct embryonic stem cell research to companies that are sponsoring such research at Wisconsin non-profit and academic institutions," according to a story by reporter Kathleen Gallagher of the Milwaukee Journal Sentinel.
Reporter Anita Weier wrote in the Wisconsin State Journal:
"The agreement will give the state a significant competitive edge over California and other states that have been investing heavily in stem cell research. Doyle hopes to lure research companies to the state in order to capture 10 percent of the national stem cell market by 2015."On the topic of challenges to WARF's patents by two nonprofit groups, Gallagher quoted Beth Donley, WARF's attorney, as saying,
"I find it fairly hypocritical that California says things like 'They need to get the dollar signs out of their eyes' because we license our technology to raise money to fund our research.Jerry Flanagan is a health care advocate with the Foundation for Taxpayer and Consumers Rights, one of the nonprofit groups challenging the WARF patents.
"We're just doing it the Midwestern way: We made an invention, and we're licensing this technology to fund the research, rather than like in California, where they borrow $3 billion, then hope to make an invention and repay the money."
Reacting to Doyle's move, he said,
"The agreement between Gov. Doyle and WARF is an acknowledgment that the overly broad WARF patents stymie research and delay cures. It is absurd that WARF, or any organization, could own the rights to life itself. For the good of patients, these patents must be dissolved."
Friday, September 29, 2006
Two Days and Two Very Different Stem Cell Conversations
Biopolitics, biocapital and, yes, even biopiracy were all part of the rhetoric at a stem cell and ethics conference in San Francisco on Friday.
This one was offered up by UC Berkeley and UC San Francisco and was a tad different than the egg risk conference staged a day earlier by the Institute of Medicine and CIRM, also in the San Francisco area.
The expression "biopiracy" was never heard at the CIRM session. It would have shocked the room of physicians and scientists. Yet in many ways the concerns were the same both days. "Do no harm" was heard more than once at the CIRM conference, which explored some of the obligations of the medical and science commnity to egg donors.
"What do we owe each other," was a central theme of the UC conference, according to historian David Rothman of Columbia University, one of its final speakers.
He noted that it is a question that would not have been asked at the time of the creation of the National Institutes of Health.
Our read, albeit sketchy, on the group at UC San Francisco on Friday was that many in it were generally hostile concerning the stem cell efforts at CIRM and elsewhere around the world. More so than the usual critics who turn up at CIRM meetings. We were told that two scientists had refused to appear before the group when it was trying to arrange speakers.
Given that environment, and to his credit, Arnold Kriegstein, director of the stem cell program at UC San Francisco, appeared as the final speaker. He acknowledged that one concern of stem cell researchers is fraud. "We seem to be blessed with more of it more than the rest of science," he said.
Kriegstein said his researchers are trying to perform their work in an ethical way, which he said requires vigilance in a fast-moving area such as stem cell research.
A video recording of the session was made on Friday along with what appeared to be a transcript. Hopefully, those will be available on the Web site of the Science, Technoloogy and Society Center at UC Berkeley, which sponsored the conference.
This one was offered up by UC Berkeley and UC San Francisco and was a tad different than the egg risk conference staged a day earlier by the Institute of Medicine and CIRM, also in the San Francisco area.
The expression "biopiracy" was never heard at the CIRM session. It would have shocked the room of physicians and scientists. Yet in many ways the concerns were the same both days. "Do no harm" was heard more than once at the CIRM conference, which explored some of the obligations of the medical and science commnity to egg donors.
"What do we owe each other," was a central theme of the UC conference, according to historian David Rothman of Columbia University, one of its final speakers.
He noted that it is a question that would not have been asked at the time of the creation of the National Institutes of Health.
Our read, albeit sketchy, on the group at UC San Francisco on Friday was that many in it were generally hostile concerning the stem cell efforts at CIRM and elsewhere around the world. More so than the usual critics who turn up at CIRM meetings. We were told that two scientists had refused to appear before the group when it was trying to arrange speakers.
Given that environment, and to his credit, Arnold Kriegstein, director of the stem cell program at UC San Francisco, appeared as the final speaker. He acknowledged that one concern of stem cell researchers is fraud. "We seem to be blessed with more of it more than the rest of science," he said.
Kriegstein said his researchers are trying to perform their work in an ethical way, which he said requires vigilance in a fast-moving area such as stem cell research.
A video recording of the session was made on Friday along with what appeared to be a transcript. Hopefully, those will be available on the Web site of the Science, Technoloogy and Society Center at UC Berkeley, which sponsored the conference.
Thursday, September 28, 2006
Kleffman's Coverage on Egg Risk is First Out of the Cyberspace Gate
Online news reports on today's egg risk conference came early. Reporter Sandy Kleffman of the Contra Costa Times wrote a piece that is now available on the Web, many hours before it will appear tomorrow in the recycled-tree version of the publication.
Here is her lead:
"The women who donate eggs to California's $3 billion stem cell research program may take great pride in serving as medical pioneers, but they could also face psychological and health risks that have not been fully explored by scientists, experts said Thursday.
"Many of the nation's top scholars in fertility and women's health gathered in Burlingame for an all-day hearing to assess how much is known about the risks egg donors face.
"Their conclusion: Many questions remain."
Here is her lead:
"The women who donate eggs to California's $3 billion stem cell research program may take great pride in serving as medical pioneers, but they could also face psychological and health risks that have not been fully explored by scientists, experts said Thursday.
"Many of the nation's top scholars in fertility and women's health gathered in Burlingame for an all-day hearing to assess how much is known about the risks egg donors face.
"Their conclusion: Many questions remain."
Scientists Call for More Study of Egg Donation Effects
The dome did not blow off the Capitol, so to speak, at today's much-heralded conference on the medical risks of egg donation.
Probably nobody really expected an explosion anyway. But the meeting did force attention on a difficult and controversial issue – one that needs considerable tending not only for the sake of the women donors but for the general cause of embryonic stem cell research.
The occasion was the Institute of Medicine's "Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research" – a title almost as heavy as the subject.
CIRM instigated the meeting, seeking more input for its efforts to craft solid standards for stem cell research. And CIRM was paying attention. Several staffers were there and at least one Oversight Committee member. CIRM President Zach Hall opened the session and was there for the entire day, taking copious notes during the end-of-the-session summary by Linda Giudice, chair of the session and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at UC San Francisco.
The bottom line on the meeting: The process of extracting eggs has risks, but they are minimal, as understood by medical science at this point. But weaknesses exist in the current data, which primarily involve women who sought IVF because of fertility problems. More study needs to be done on "healthy" individuals who undergo the process solely for the purposes of donating eggs.
Giudice noted that despite 20 years of IVF in this country, not much is known on the health outcomes of those treated. "Varied" and "limited" are how she described the studies.
Giudice outlined some "challenges" facing scientists. They include differences in the way ovaries are stimulated to produce large amounts of eggs, finding alternate sources (possibly cadavers) and organization of the donation process.
While the meeting was devoted to medical issues, lying in the weeds were policy questions. Minimizing risk to donors can translate to changes in CIRM's research standards. And creating a database on the health of donors could be the focus of a CIRM grant.
The meeting was Webcast by the Institute of Medicine and presumably will be available online for viewing at your convenience at some point. CIRM had a court stenographer making a transcript which may be accessible online in a couple of weeks. And the California Stem Cell Report will have more on the session in the next few days.
Meanwhile, for those of you who were there or even those who were not, your comments or questions are invited. Just click on the word "comments" below. They can even be posted anonymously with your identity concealed even from the otherwise all-knowing California Stem Cell Report.
Probably nobody really expected an explosion anyway. But the meeting did force attention on a difficult and controversial issue – one that needs considerable tending not only for the sake of the women donors but for the general cause of embryonic stem cell research.
The occasion was the Institute of Medicine's "Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research" – a title almost as heavy as the subject.
CIRM instigated the meeting, seeking more input for its efforts to craft solid standards for stem cell research. And CIRM was paying attention. Several staffers were there and at least one Oversight Committee member. CIRM President Zach Hall opened the session and was there for the entire day, taking copious notes during the end-of-the-session summary by Linda Giudice, chair of the session and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at UC San Francisco.
The bottom line on the meeting: The process of extracting eggs has risks, but they are minimal, as understood by medical science at this point. But weaknesses exist in the current data, which primarily involve women who sought IVF because of fertility problems. More study needs to be done on "healthy" individuals who undergo the process solely for the purposes of donating eggs.
Giudice noted that despite 20 years of IVF in this country, not much is known on the health outcomes of those treated. "Varied" and "limited" are how she described the studies.
Giudice outlined some "challenges" facing scientists. They include differences in the way ovaries are stimulated to produce large amounts of eggs, finding alternate sources (possibly cadavers) and organization of the donation process.
While the meeting was devoted to medical issues, lying in the weeds were policy questions. Minimizing risk to donors can translate to changes in CIRM's research standards. And creating a database on the health of donors could be the focus of a CIRM grant.
The meeting was Webcast by the Institute of Medicine and presumably will be available online for viewing at your convenience at some point. CIRM had a court stenographer making a transcript which may be accessible online in a couple of weeks. And the California Stem Cell Report will have more on the session in the next few days.
Meanwhile, for those of you who were there or even those who were not, your comments or questions are invited. Just click on the word "comments" below. They can even be posted anonymously with your identity concealed even from the otherwise all-knowing California Stem Cell Report.
Wednesday, September 27, 2006
Multimillion Dollar Stem Cell Lab Building Program: The First Step
Building tens of millions of dollars in biomedical research facilities is the topic for next Monday's meeting of a working group of the California stem cell agency.
The Scientific and Medical Facilities Working Group will consider criteria for its initial grants which are likely to be approved early next year – upwards of $2 million per institution has been discussed at possibly 15 different locations. Funds would go for lab renovations and equipment.
Also on the agenda for the San Francisco meeting (no remote locations available) is a panel discussion on construction of biomedical research facilities. James Kovach, president of the Buck Institute on Aging; Rebekah Gladson, campus architect at UC Irvine, and Curtis Williams, vice president for capital construction, USC, are scheduled to take part.
The working group has 11 members. Six are patient advocates from the Oversight Committee. Four are real estate specialists, and the 11th is the chair of the Oversight Committee, Robert Klein, whose career has been in real estate development.
The Scientific and Medical Facilities Working Group will consider criteria for its initial grants which are likely to be approved early next year – upwards of $2 million per institution has been discussed at possibly 15 different locations. Funds would go for lab renovations and equipment.
Also on the agenda for the San Francisco meeting (no remote locations available) is a panel discussion on construction of biomedical research facilities. James Kovach, president of the Buck Institute on Aging; Rebekah Gladson, campus architect at UC Irvine, and Curtis Williams, vice president for capital construction, USC, are scheduled to take part.
The working group has 11 members. Six are patient advocates from the Oversight Committee. Four are real estate specialists, and the 11th is the chair of the Oversight Committee, Robert Klein, whose career has been in real estate development.
Egg Donation: 'People Think You Just Go In and Grab Some'
A day in the life of an egg donor:
Another excerpt:
"Somehow overcoming her fear of needles, (Julia) Thurman reported for a checkup midway through her regimen of ovary-stimulating shots. She felt fine, but her arms were tender from repeated blood draws -- four that week alone.That's an excerpt from an exceptional story by reporter Edie Lau of The Sacramento Bee on the experiences of one egg donor at the University of California at Davis. She followed a woman through the process, laying out the details in a vivid but restrained account. The name of the woman was changed in the article for privacy reasons.
"A circle of red dots ringed her bellybutton, a calendar of shots past. Just below her bikini line was a greenish bruise.
"Four days later, the hormone surge was impossible to ignore. Thurman shuffled into the clinic, pale and slumping.
"'I don't feel very good today. My stomach hurts.' Her voice was flat. On the ride over, she thought she might throw up.
"'Is it your ovaries?' asked the doctor, Stephen Boyers, head of the division of reproductive endocrinology at UC Davis Medical Center.
"'It's my stomach.' She patted the spot.
"'That's your ovaries,'" Boyers replied.
"Thurman lay back for an ultrasound exam. Follicles showed on the computer screen as dark blobs like plums. 'These are ready,' the doctor pronounced."
Another excerpt:
"Thurman herself knew nothing at first of the arduous process called superovulation that drives the ovaries to produce up to dozens of eggs at one time. She did not know about the daily hormone shots in the stomach, how ovaries swell from the size of walnuts to the size of oranges or grapefruits, or of the 12-inch needle used to extract the eggs.The article was the result of cooperation between UC Davis and the woman involved. Lau wrote:
"Nor did she know about the hundreds of personal questions she'd have to answer during the screening, or the dozens of clinic visits required for invasive and uncomfortable tests and probes.
"More important, she did not know about the risks involved. Data about complications are scattered, inconsistent and incomplete, leaving even scientists without a full understanding of potential dangers.
"The lack of reliable information has spurred the state stem cell agency, the California Institute for Regenerative Medicine, to sponsor the first workshop on the subject. The meeting takes place Thursday in San Francisco."
"Revealing a world usually hidden by medical confidentiality policies, the UC Davis Medical Center fertility clinic allowed The Bee to follow a donor through the process if she were not identified.UC Davis and Thurman are to be commended for allowing Lau to pursue her story. Lau's perceptive reporting and restrained writing have added significantly to the discussion of women, eggs and stem cells.
"Thurman agreed to share her experience so others could glimpse the complex procedure required to donate eggs. 'I think people think you just go in and grab some,' she said."
Tuesday, September 26, 2006
Ortiz Legislation to Protect Egg Donors Signed Into Law
In a week when egg donations and stem cell ethics are the subject of some considerable attention, Gov. Schwarzenegger has signed the nation's first legislation aimed at protecting women who donate eggs for embryonic stem cell research.
The measure – SB1260 – was authored by Sen. Deborah Ortiz, who is one of the leading and early California advocates of stem cell research.
Marcy Darnovsky of the Center for Genetics and Society of Oakland, Ca., called the signing a "victory for women's health." She said,
Ortiz' office summarized the measure, which deals with non-CIRM research, in a press release:
The Republican governor, who is in a campaign for re-election, buried the signing of the measure in a generic press release about a number of bills he signed related to women's health.
Here are links on the signing and the legislation: Ortiz press release, governor's press release, statement by Darnovsky, a text of the legislation and the last legislative analysis of the bill.
The measure – SB1260 – was authored by Sen. Deborah Ortiz, who is one of the leading and early California advocates of stem cell research.
Marcy Darnovsky of the Center for Genetics and Society of Oakland, Ca., called the signing a "victory for women's health." She said,
"Similar provisions have been adopted as law in other countries and recommended as voluntary guidelines elsewhere in the United States, but the new California law is the first of its kind in the country."Darnovsky continued:
"The passage of SB 1260 has taken on added importance because several biotechnology companies and research teams in California have begun experimenting with cloning techniques (known as somatic cell nuclear transfer or SCNT), which require large numbers of women’s eggs. An increasing number of scientists believe that if it is ever perfected, SCNT will be useful as an indirect research tool, not as the basis of medical treatments. But following revelations late last year of fabricated data and fraudulent claims of success by cloning researcher Woo Suk Hwang, what many have called a 'cloning race' has resumed.The bill signing comes two days before the CIRM conference on medical risks of egg donation and a UC Berkeley/UC San Francisco conference on stem cell ethics. (See separate items below.)
"We hope that the Reproductive Health and Research bill is a step towards the consistent and comprehensive national regulation of stem cell research that the United States so urgently needs."
Ortiz' office summarized the measure, which deals with non-CIRM research, in a press release:
"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of the potential risks. The donors must provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production procedures. In accordance with the National Academy of Sciences, SB 1260 limits compensation to only allow reimbursement for direct expenses. This will ensure consistency between the procurement of eggs in California and other countries that have similar embryonic stem cell research programs and streamline international collaborations and the sharing of stem cell lines. It also ensures consistency with the limitations enacted in Proposition 71, the 2004 initiative that created the California Institute for Regenerative Medicine."Ortiz said,
“Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans. We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.”Ortiz, a Sacramento Democrat, authored legislation in 2002 that made California the first state to authorize embryonic stem cell research. She is leaving the legislature this year because of a law that limits the number of terms an individual can hold office.
The Republican governor, who is in a campaign for re-election, buried the signing of the measure in a generic press release about a number of bills he signed related to women's health.
Here are links on the signing and the legislation: Ortiz press release, governor's press release, statement by Darnovsky, a text of the legislation and the last legislative analysis of the bill.
Coming Up
California legislation aimed at protecting women who donate eggs for stem cell research has been signed by the governor. We will have an item on it within the hour.
Live Webcast Set for CIRM Egg Donation Conference Thursday
For those of you who can't make the Institute of Medicine/CIRM daylong conference on the latest information on the medical risks of egg donation, you can catch all of it on a live Webcast.
The Thursday event is being held in San Francisco to "to assess and explore the nature and magnitude of risks, evaluating areas where more data are required, and assessing what is known about the potential for reducing risks through changes in procedures." Ethical and policy issues will not be a prime topic.
Advance registration is required for the conference, and the deadline is past, but you might be able to slip in. Here is the link to the registration site.
If not, the Webcast links will be active beginning at 7:30 a.m. PDT on Thursday. The institute advises that it is important to test your links in advance, which can be done at any time. See this site for details.
The Thursday event is being held in San Francisco to "to assess and explore the nature and magnitude of risks, evaluating areas where more data are required, and assessing what is known about the potential for reducing risks through changes in procedures." Ethical and policy issues will not be a prime topic.
Advance registration is required for the conference, and the deadline is past, but you might be able to slip in. Here is the link to the registration site.
If not, the Webcast links will be active beginning at 7:30 a.m. PDT on Thursday. The institute advises that it is important to test your links in advance, which can be done at any time. See this site for details.
More Attention Needed to Public Needs in Stem Cell Research
More attention should be focused on the public obligations of embryonic stem cell research, says a UC Berkeley faculty member in an article in "Trends in Biotechnology."
David Winickoff, who is a discussant at a two-day stem cell and ethics conference later this week in the San Francisco Bay area, wrote:
David Winickoff, who is a discussant at a two-day stem cell and ethics conference later this week in the San Francisco Bay area, wrote:
"In the USA the selection of funding priorities, IP policies, a regime of egg donation in California, and other public initiatives will help set the national and international trajectory for hESC research. Considering the high stakes of these policies, more attention should focus on the public obligations of government-funded hESC research and its commitment to an equitable distribution of risks and benefits as policies are implemented. Taking a cue from the UK, centralized stem cell banking in California would bring general gains in efficiency and create a pragmatic opportunity to construct an ethical and legal architecture for long-term public return. This vision of stem cell banks as social infrastructure would provide useful flexibility in the face of a fast-evolving ethical frontier and help build trust between scientific institutions and society."Winickoff, an assistant professor of bioethics and society, will appear on the panel on Friday at UC San Francisco on academy-industry alliances. Here is a link to the full schedule and other details.
Monday, September 25, 2006
Governor's Press Release on Azziz
Here is the link to the governor's press release on Ricardo Azziz.
LA Doc Named to CIRM Oversight Committee
The California stem cell agency has added a new member to its Oversight Committee – Ricardo Azziz, a physician who is chair of the Department of Obstetrics and Gynecology at Cedars-Sinai Medical Center in Los Angeles.
Gov. Arnold Schwazenegger appointed Azzis to the 29-member panel, replacing Keith Black, who resigned earlier this year.
Azziz is also a professor at the UCLA school of medicine and vice chair of the obstetrics department there. Previously he was with the University of Alabama.
Here is a link to the CIRM press release and the Cedars press release. Here is his bio page at Cedars. As far as we can tell, the governor's press office has not yet issued a release on Azziz.
Gov. Arnold Schwazenegger appointed Azzis to the 29-member panel, replacing Keith Black, who resigned earlier this year.
Azziz is also a professor at the UCLA school of medicine and vice chair of the obstetrics department there. Previously he was with the University of Alabama.
Here is a link to the CIRM press release and the Cedars press release. Here is his bio page at Cedars. As far as we can tell, the governor's press office has not yet issued a release on Azziz.
Watchdog Group Praises CIRM IP Task Force
The California stem cell agency is sort of like the weather – as they say, everybody complains about it, or so it seems sometimes.
Now comes a note from one of the folks who has done some pretty consistent complaining, but also seems to be able to work with CIRM.
He is John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca.. He said in a letter to Ed Penhoet, chair of the CIRM Intellectual Property Task Force:
He referred to a Sept. 15 letter.from the California Healthcare Institute concerning IP policies for businesses. Written by David Gollaher, president of the biomedical industry group, the letter said that the organization "remains concerned" particularly about the process through which the Oversight Committee and the Task Force have "addressed or failed to address substantial concerns" of the CHI.
Gollaher said he was "especially dismayed by the apparent disregard" of some CHI comments concerning access to CIRM-financed therapies by the uninsured and public agencies. He also expressed concern about the process involving "right to practice" language.
Now comes a note from one of the folks who has done some pretty consistent complaining, but also seems to be able to work with CIRM.
He is John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca.. He said in a letter to Ed Penhoet, chair of the CIRM Intellectual Property Task Force:
"The IP Task Force, under your chairmanship and with the stellar staff support of Mary Maxon and Scott Tocher, has so far exemplified a perfect model of soliciting and considering input from all stakeholders."The impetus for Simpson's remark was what he called a "disturbing suggestion from some biotech industry representatives that the Task Force's process was other than transparent, orderly and consistent."
He referred to a Sept. 15 letter.from the California Healthcare Institute concerning IP policies for businesses. Written by David Gollaher, president of the biomedical industry group, the letter said that the organization "remains concerned" particularly about the process through which the Oversight Committee and the Task Force have "addressed or failed to address substantial concerns" of the CHI.
Gollaher said he was "especially dismayed by the apparent disregard" of some CHI comments concerning access to CIRM-financed therapies by the uninsured and public agencies. He also expressed concern about the process involving "right to practice" language.
"We would have expected any decision-making process...to have included input from all interested stakeholders. This, unfortunately, was not the case. In the future, CHI urges the ICOC to ensure its processes are transparent, orderly and consistent."
Stem Cell Snippets: Sherry Lansing to Stanford Freebies
Here are some links to interesting news, information or press releases related to California stem cell issues.
Sherry Lansing – CIRM Oversight Committee member Sherry Lansing, once a bigtime Hollywood executive, discusses her what makes her tick now. "I loved my job, but at a certain point it became repetitive. The highs weren't as high, and the lows weren't as low. So I asked myself: What is it that really gives me pleasure? The answer is giving back."
CIRM Overseer Flap – More from the Foundation for Taxpayer and Consumers Rights which is dogging the California attorney general concerning what is says is the illegal appointment of John Hein to the panel that reviews the financial operations of the California stem cell agency.
Stem Cell Bank –Joe Vanden Plas of the Wisconsin Technology Network reports: "The Madison-based National Stem Cell Bank has announced it will receive human embryonic stem cells from the University of California-San Francisco, giving it 13 of the 21 stem cell lines available on the federal registry."
Medical Freebies – In case you missed this, here is a link to the Los Angeles Times, which wrote: "They are common fixtures in many medical practices: free pens, mugs, stationery, stethoscopes and doctors' bags, all emblazoned with the logo of a new drug or a pharmaceutical firm. And those catered lunches staffers flock to? It may be courtesy of a major drug supplier. No more — at least for all staff and students at Stanford University's medical school, hospitals and clinics. Under a policy announced Tuesday, even free sticky notes violate ethics rules."
Sherry Lansing – CIRM Oversight Committee member Sherry Lansing, once a bigtime Hollywood executive, discusses her what makes her tick now. "I loved my job, but at a certain point it became repetitive. The highs weren't as high, and the lows weren't as low. So I asked myself: What is it that really gives me pleasure? The answer is giving back."
CIRM Overseer Flap – More from the Foundation for Taxpayer and Consumers Rights which is dogging the California attorney general concerning what is says is the illegal appointment of John Hein to the panel that reviews the financial operations of the California stem cell agency.
Stem Cell Bank –Joe Vanden Plas of the Wisconsin Technology Network reports: "The Madison-based National Stem Cell Bank has announced it will receive human embryonic stem cells from the University of California-San Francisco, giving it 13 of the 21 stem cell lines available on the federal registry."
Medical Freebies – In case you missed this, here is a link to the Los Angeles Times, which wrote: "They are common fixtures in many medical practices: free pens, mugs, stationery, stethoscopes and doctors' bags, all emblazoned with the logo of a new drug or a pharmaceutical firm. And those catered lunches staffers flock to? It may be courtesy of a major drug supplier. No more — at least for all staff and students at Stanford University's medical school, hospitals and clinics. Under a policy announced Tuesday, even free sticky notes violate ethics rules."
Sunday, September 24, 2006
Open Access: Suber Rebuts
Open access advocate Peter Suber has challenged statements by Duane Roth and the fears of the UC Berkeley researchers concerning the move towards open access at CIRM. You can find his full comments here.
Open Access: Time to Catch the Wave
The drive for open access at the California stem cell agency moved forward last week with a presentation by University of California officials to the agency's Intellectual Property Task Force.
Following the Thursday session, Ed Penhoet, chair of the Task Force, said the group had heard "strong sentiment" for open access as described by the UC officials. But he noted that UC itself has not implemented open access policies even after three years of discussion. One UC official said he expected they may be approved next spring. Penhoet said CIRM will continue to work on the issue.
Open access means faster dissemination of research, more use of the information by other scholars and a reduction in cost to readers, according to the open access advocates.
Ben Crow, chair of the UC Academic Senate's committee on libraries, likened the impact of the Web and the Internet to the invention of printing, indicating that it was a force impossible to resist.
Francisco Prieto, a CIRM Oversight Committee member, said that sharing of research and transparency is a "bedrock principle" at CIRM. He said that open access is becoming "the standard" and that "perhaps we should push it."
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said, "We're paying for it. We ought to be able to see it."
But Oversight Committee member Duane Roth said the marketplace seemed to be dealing with the issue of open access. He said he was "not sure CIRM should be doing something NIH isn't."
Because of the impact of open access, Roth also raised the specter of scientific journals changing from a subscription-based business model to the advertiser-based model that newspapers follow.
One faculty member from UC Berkeley noted that young researchers in his lab opposed open access policies because of the likelihood that they would limit their ability to have their research published in the top scientific journals. Publication in such journals is the key to securing good faculty positions, they said.
Coincidentally, a group of senior academic officials from around the country, including Barbara Horwitz, vice provost-academic personnel, at UC Davis, released a letter on Friday opposing federal open access legislation. Their letter contained a link to a Web site supporting the position of scientific journals.
Our comment: Fighting the Web is like trying to fight the tide. No information enterprise can resist it successfully. Newspapers, to their financial pain, have discovered that the hard way with significant loss of revenue. (However, their current sad state of economic affairs has more complex origins and was well underway prior to the widespread use of the Web.)
The choice before the scientific journals is whether to ride the wave of Web or to be smashed into the financial rocks trying to fight it. CIRM too really has no choice. It can only fiddle with the details.
As for the hiring practices at places like UC, changing realities will force some adjustments. Cheap sorting mechanisms such as counting the number of articles a scholar has published in a handful of journals are probably somewhat inappropriate any way. It is time to build a better model for finding good minds.
In addition to Crow, John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate appeared before IP Task Force.. The UC Berkeley faculty member that we mentioned got away before we could get his correct name. For more on open access and CIRM, see "fading print" and "call for open access."
Following the Thursday session, Ed Penhoet, chair of the Task Force, said the group had heard "strong sentiment" for open access as described by the UC officials. But he noted that UC itself has not implemented open access policies even after three years of discussion. One UC official said he expected they may be approved next spring. Penhoet said CIRM will continue to work on the issue.
Open access means faster dissemination of research, more use of the information by other scholars and a reduction in cost to readers, according to the open access advocates.
Ben Crow, chair of the UC Academic Senate's committee on libraries, likened the impact of the Web and the Internet to the invention of printing, indicating that it was a force impossible to resist.
Francisco Prieto, a CIRM Oversight Committee member, said that sharing of research and transparency is a "bedrock principle" at CIRM. He said that open access is becoming "the standard" and that "perhaps we should push it."
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said, "We're paying for it. We ought to be able to see it."
But Oversight Committee member Duane Roth said the marketplace seemed to be dealing with the issue of open access. He said he was "not sure CIRM should be doing something NIH isn't."
Because of the impact of open access, Roth also raised the specter of scientific journals changing from a subscription-based business model to the advertiser-based model that newspapers follow.
One faculty member from UC Berkeley noted that young researchers in his lab opposed open access policies because of the likelihood that they would limit their ability to have their research published in the top scientific journals. Publication in such journals is the key to securing good faculty positions, they said.
Coincidentally, a group of senior academic officials from around the country, including Barbara Horwitz, vice provost-academic personnel, at UC Davis, released a letter on Friday opposing federal open access legislation. Their letter contained a link to a Web site supporting the position of scientific journals.
Our comment: Fighting the Web is like trying to fight the tide. No information enterprise can resist it successfully. Newspapers, to their financial pain, have discovered that the hard way with significant loss of revenue. (However, their current sad state of economic affairs has more complex origins and was well underway prior to the widespread use of the Web.)
The choice before the scientific journals is whether to ride the wave of Web or to be smashed into the financial rocks trying to fight it. CIRM too really has no choice. It can only fiddle with the details.
As for the hiring practices at places like UC, changing realities will force some adjustments. Cheap sorting mechanisms such as counting the number of articles a scholar has published in a handful of journals are probably somewhat inappropriate any way. It is time to build a better model for finding good minds.
In addition to Crow, John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate appeared before IP Task Force.. The UC Berkeley faculty member that we mentioned got away before we could get his correct name. For more on open access and CIRM, see "fading print" and "call for open access."
Friday, September 22, 2006
Not Coming Up
We are holding off on our item on the open access discussions at CIRM despite our earlier promise to have something today. But here is the bottom line, IP Task Force Chairman Ed Penhoet said there was "strong support" for open access. More consideration of matter will come up in the future. The full item will be up by sometime tomorrow.
IP Policy for Business Moves on to Final Step
Call it the 25 percent conundrum. Or the payback puzzle.
That was one key issue facing the Intellectual Property Task Force of the California stem cell agency during its meeting Thursday on IP policy for grants to businesses.
Specifically, when do businesses have to come up with plans for access to CIRM-financed therapies, making them available to the uninsured and public agencies in California? (You folks out of state are out of luck.)
As originally proposed, businesses would have to come up with access plans when the agency's funding exceeded 25 percent of the invention. At that threshold, they would also have to provide therapies at the "federal Medicaid price" when the therapies were purchased with public funds.
The committee expressed concern about definitions of such terms as the Medicaid price and public funds, which are expected to be clarified in time for the Oct. 11 Oversight Committee meeting.
Task Force Chair Ed Penhoet introduced the topic of the 25 percent trigger by noting that some companies would find it onerous. Francisco Prieto of Sacramento, another Task Force member, said he "pulled the number out of my hat" when he originally suggested it.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said a percentage might be the wrong approach. He suggested tieing access plans to when a CIRM grant was made -- a "decisive point." After discussion about concepts other than a flat percentage including the idea of an "enabling amount" from San Francisco attorney Ken Taymor of MBV Law LLP, Penhoet indicated the staff would work on a percentage figure that varied, depending on when it was made in the process of the development of the therapy. Generally, the percentage would be larger at an earlier stage and grow smaller as the development cycle matured. What ultimately will be proposed will have to wait until closer to the Oversight Committee meeting.
Todd Gillenwater, vice president for public policy for the California Healthcare Institute, a biomedical industry association, said he was reserving a position on the percentage, pending completion of informal survey of some of the group's members.
Also up for clarification prior to the October meeting is language requiring the sharing of biomedical materials. Members of the Task Force were concerned about creating a burden on companies but also wanted to ensure the free flow of research. A representative of Applied Biosystems of Foster City, Ca., said he would like a provision that would allow companies to make a profit on research tools.
Most of the rest of the draft IP policy remained relatively unchanged.
Speaking to audience of 15 to 20 persons, Penhoet noted the difficulty in devising a commercial IP policy even after months of work and detailed testimony from a number of businesses. He indicated that the Task Force had plowed much new ground. Penhoet said there was a dearth of organized material on the questions before CIRM, declaring that his deputy, Mary Maxon, who performed virtually all of the research, had become the "world authority" on the subject.
The Task Force did not have a quorum for the discussion, and no vote was taken. But Penhoet was given an affirmative response when he asked the other members whether he had their permission to take the IP draft to the Oversight Committee. The meeting took place in CIRM's San Francisco headquarters. Four members of the 12-member group participated through a conference call connection. No media were present with the exception of the California Stem Cell Report.
(Editor's note: A slightly earlier version of this item contained an error in the 7th paragraph. It incorrectly stated that the variable percentage would be smaller initially instead of larger.)
That was one key issue facing the Intellectual Property Task Force of the California stem cell agency during its meeting Thursday on IP policy for grants to businesses.
Specifically, when do businesses have to come up with plans for access to CIRM-financed therapies, making them available to the uninsured and public agencies in California? (You folks out of state are out of luck.)
As originally proposed, businesses would have to come up with access plans when the agency's funding exceeded 25 percent of the invention. At that threshold, they would also have to provide therapies at the "federal Medicaid price" when the therapies were purchased with public funds.
The committee expressed concern about definitions of such terms as the Medicaid price and public funds, which are expected to be clarified in time for the Oct. 11 Oversight Committee meeting.
Task Force Chair Ed Penhoet introduced the topic of the 25 percent trigger by noting that some companies would find it onerous. Francisco Prieto of Sacramento, another Task Force member, said he "pulled the number out of my hat" when he originally suggested it.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said a percentage might be the wrong approach. He suggested tieing access plans to when a CIRM grant was made -- a "decisive point." After discussion about concepts other than a flat percentage including the idea of an "enabling amount" from San Francisco attorney Ken Taymor of MBV Law LLP, Penhoet indicated the staff would work on a percentage figure that varied, depending on when it was made in the process of the development of the therapy. Generally, the percentage would be larger at an earlier stage and grow smaller as the development cycle matured. What ultimately will be proposed will have to wait until closer to the Oversight Committee meeting.
Todd Gillenwater, vice president for public policy for the California Healthcare Institute, a biomedical industry association, said he was reserving a position on the percentage, pending completion of informal survey of some of the group's members.
Also up for clarification prior to the October meeting is language requiring the sharing of biomedical materials. Members of the Task Force were concerned about creating a burden on companies but also wanted to ensure the free flow of research. A representative of Applied Biosystems of Foster City, Ca., said he would like a provision that would allow companies to make a profit on research tools.
Most of the rest of the draft IP policy remained relatively unchanged.
Speaking to audience of 15 to 20 persons, Penhoet noted the difficulty in devising a commercial IP policy even after months of work and detailed testimony from a number of businesses. He indicated that the Task Force had plowed much new ground. Penhoet said there was a dearth of organized material on the questions before CIRM, declaring that his deputy, Mary Maxon, who performed virtually all of the research, had become the "world authority" on the subject.
The Task Force did not have a quorum for the discussion, and no vote was taken. But Penhoet was given an affirmative response when he asked the other members whether he had their permission to take the IP draft to the Oversight Committee. The meeting took place in CIRM's San Francisco headquarters. Four members of the 12-member group participated through a conference call connection. No media were present with the exception of the California Stem Cell Report.
(Editor's note: A slightly earlier version of this item contained an error in the 7th paragraph. It incorrectly stated that the variable percentage would be smaller initially instead of larger.)
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