Friday, August 11, 2006
CIRM Oversight Legislation Set for Thursday Hearing
The legislation to tighten oversight of the California stem cell agency, mentioned in the item below, is now scheduled to be heard next Thursday by the Assembly Appropriations Committee. No time was given but the committee usually is scheduled to begin work about 9 a.m. Ortiz' amendments still have not caught up with the version of SB401 available on the Web.
Thursday, August 10, 2006
Proposal to Tighten CIRM Oversight Coming Up Next Week
Sweeping legislation to tighten oversight of the California stem cell agency is likely to come up before the state Assembly Appropriations Committee in the middle of next week, its last stop before it would reach the Assembly floor.
To be enacted, the bill (SB401) by Sen. Deborah Ortiz, D-Sacramento, must be approved by the committee, pass the Assembly and then the Senate, before going on to the governor for his action. If he signs the measure or allows it to become enacted without his signature, it would then be placed on a statewide ballot – not this fall – for voter approval.
Given the governor's $150 million bailout of CIRM, it seems more likely that he would veto Ortiz' legislation. But speculating on what may happen while he is running for re-election is fraught with pitfalls.
The bill is opposed by CIRM and some in the biotech business, although most of the opposition was registered prior to the latest amendments, one of which removed a provision to place the measure on the fall ballot. Other amendments basically conformed the measure's IP policy to what CIRM has already approved.
CIRM Chairman Robert Klein was not apparently satisfied with the position of his agency on the measure last spring. He wrote a harshly worded letter circulated nationally concerning the bill. Klein described Ortiz, a longtime supporter of stem cell research including Prop. 71, as an "ongoing threat" to that entire field of science. CIRM refused to comment on the letter, which Klein wrote as head of Americans for Stem Cell Therapies and Cures, a political advocacy group headquartered in his Palo Alto office.
Patient advocate Don Reed of Hayward, Ca., earlier this year began a letter-writing effort against the measure. However, at the moment it does not seem at the top of his agenda, based on a look at this web site, Stemcellbattles.com.
Ortiz' amendments have not yet caught up with the official version of the bill on the Web, but are likely to do so before it comes up either next Wednesday or Thursday.
Here are links to the Klein letter, a discussion of its "facts," and a background statement from Klein's group.
To be enacted, the bill (SB401) by Sen. Deborah Ortiz, D-Sacramento, must be approved by the committee, pass the Assembly and then the Senate, before going on to the governor for his action. If he signs the measure or allows it to become enacted without his signature, it would then be placed on a statewide ballot – not this fall – for voter approval.
Given the governor's $150 million bailout of CIRM, it seems more likely that he would veto Ortiz' legislation. But speculating on what may happen while he is running for re-election is fraught with pitfalls.
The bill is opposed by CIRM and some in the biotech business, although most of the opposition was registered prior to the latest amendments, one of which removed a provision to place the measure on the fall ballot. Other amendments basically conformed the measure's IP policy to what CIRM has already approved.
CIRM Chairman Robert Klein was not apparently satisfied with the position of his agency on the measure last spring. He wrote a harshly worded letter circulated nationally concerning the bill. Klein described Ortiz, a longtime supporter of stem cell research including Prop. 71, as an "ongoing threat" to that entire field of science. CIRM refused to comment on the letter, which Klein wrote as head of Americans for Stem Cell Therapies and Cures, a political advocacy group headquartered in his Palo Alto office.
Patient advocate Don Reed of Hayward, Ca., earlier this year began a letter-writing effort against the measure. However, at the moment it does not seem at the top of his agenda, based on a look at this web site, Stemcellbattles.com.
Ortiz' amendments have not yet caught up with the official version of the bill on the Web, but are likely to do so before it comes up either next Wednesday or Thursday.
Here are links to the Klein letter, a discussion of its "facts," and a background statement from Klein's group.
Wednesday, August 09, 2006
Stem Cell Alliance Shutting Down
The Alliance for Stem Cell Research, a spinoff of the successful campaign for Prop. 71 in California, is closing its doors.
The group said in a press release:
In response to a query about her plans, Susan DeLaurentis, president of the alliance, said, "I plan to work as a volunteer to get candidates elected who support stem cell research. I will personally stay involved in this issue - there is
much to be done!"
The group said in a press release:
The alliance grew out of Cures for California, the campaign organization for the 2004 stem cell initiative."Recent legislative efforts have demonstrated that perhaps the most effective way for us to achieve our goals is to play a larger role in ongoing efforts to change the political landscape. In particular, we must take action to end policies that currently impose significant restrictions on the progress of stem cell research.
"As a 501(c)3 public charity, the AFSCR is limited in its
ability to lobby and directly influence legislation and election outcomes. Therefore, the Board of Directors of AFSCR has made the difficult decision to dissolve AFSCR and realign its efforts to campaign for stronger support for stem cell research on both the federal and state level."
In response to a query about her plans, Susan DeLaurentis, president of the alliance, said, "I plan to work as a volunteer to get candidates elected who support stem cell research. I will personally stay involved in this issue - there is
much to be done!"
Tuesday, August 08, 2006
The Immune Feeling of Researchers to Conflicts of Interest
Critics of the California stem cell agency have fresh scientific evidence to bolster their contention that the institute should require additional financial disclosure from members of its working groups.
The latest support comes via an Aug. 4 article in the Wall Street Journal by reporter Shirley S. Wang. She asks the question: "Why do many researchers feel they're immune to conflicts of interest?"
Answer:
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The latest support comes via an Aug. 4 article in the Wall Street Journal by reporter Shirley S. Wang. She asks the question: "Why do many researchers feel they're immune to conflicts of interest?"
Answer:
"Just as we fool ourselves into thinking we're more ethical, kind and generous than we are, so scientists can be blind to the very real possibility that their work is inappropriately influenced by financial ties. These psychological processes usually operate so subtly that people aren't aware that such ties can bias their judgment.Wang continues:
"Receiving gifts and money creates the desire, often unconscious, to give something back, says Max Bazerman of Harvard Business School. Even small gifts can have an influence. Charities that send out free address labels, for example, get more in donations than those that don't. Customers who are given a 50-cent key chain at a pharmacy spend substantially more in the store.
"Conflicts can be hard to recognize, because 'cognitive bias' comes into play. 'The mind has an enormous ability to see the world as we want,' says Dr. Bazerman."
"Studies of psychiatric drugs by researchers with a financial conflict of interest -- receiving speaking fees, owning stock, or being employed by the manufacturer -- are nearly five times as likely to find benefits in taking the drugs as studies by researchers who don't receive money from the industry, according to a review of 162 studies published last year in the American Journal of Psychiatry. Studies that the industry funded, but in which the researchers had no other financial ties, didn't have significantly different results than nonindustry-funded studies.Wang's article attracted attention on the blog of the editors of the American Journal of Bioethics, which described it as "excellent." That site also linked to another related piece by Catherine DeAngelis, editor of the Journal of the American Medical Association, in which she discusses "the sometimes unethical influence of money on medical science, a very serious issue, which has become more evident over the past year or so." Would more CIRM disclosure from scientists and physicians eliminate conflicts of interest? Certainly not, but it would tell the public when potential conflicts exist. Public disclosure would also allow other interested parties and the public to understand the financial webs surrounding often highly vaunted research. And as we know, from time to time, the early raves for therapies do not stand up to scrutiny for a host of unsavory reasons.
"Studies can be designed in ways that boost the likelihood that results will come out a certain way, says Lisa Bero of the University of California, San Francisco. A new treatment can be compared with a placebo, instead of with a treatment already in use, making finding a significant statistical difference between the two more likely. Dosage and timing of medications, which make a big difference in their effectiveness and side effects, can also be manipulated, she says."
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Monday, August 07, 2006
Clinical Stem Cell Research: Financing and Academic Medical Centers
The California stem cell agency has identified some sticky issues involving clinical research for stem cell therapies, including a "dramatic" shift away from academic medical centers.
The 10-page overview of the clinical research process was prepared as a background document for CIRM's strategic planning process. The paper covers drug development timelines, clinical networks and difficulties in financing clinical research in addition to issues involving academic medical centers.
On the subject of the centers (AMCs), here are a few excerpts:
The background paper also reported:
The 10-page overview of the clinical research process was prepared as a background document for CIRM's strategic planning process. The paper covers drug development timelines, clinical networks and difficulties in financing clinical research in addition to issues involving academic medical centers.
On the subject of the centers (AMCs), here are a few excerpts:
"We have heard anecdotally of the increasing difficulty that academic researchers face in obtaining funding for investigator-initiated research, which is due to a number of reasons:
"a. Decreased clinical margins at AMCs resulting in less discretionary funding available for research.
"b. The shrinking of the NIH budget.
"c. The general unwillingness of the pharm/biotech industries and the venture capital community to fund research that does not have direct, obvious commercial applications.
"In addition, while academics may sometimes believe that clinical research depends on the AMC, non-academics believe that clinical research, to truly thrive, needs to be present in multiple venues of care. The pharmaceutical industry is seeking more non-academic providers to conduct clinical research, which is creating enormous opportunities for hospitals, physicians and outpatient providers such as the for-profit contract-research organizations (CROs) and site-management organizations (SROs) to fulfill some of the functions traditionally carried out by AMCs. For example, at the beginning of the decade of the 90's, 80% of industry-sponsored clinical trials were placed in AMCs; by 1999 the number was down to 40%. One reason given for this shift is the amount of time it takes to gain protocol approval in academic settings: the initial approval process prior to initiation can take from two to six months in an AMC, compared with one to two months in a private hospital or less than one month in a physician’s practice.
"In an industry where speed is paramount, and where for each day’s delay in gaining FDA approval of a drug the manufacturer loses and average of $1.3 million, such delays are problematic, at best. There has also been a trend in recent years for US pharmaceutical companies to conduct clinical trials outside the US. For example, the number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500, but with less research being done at U.S. sites."
The background paper also reported:
"Given the newness, uncertainties, and challenges associated with cell-based licensing by the pharmaceutical industry or investment by the venture capital community) is unlikely to be available for such therapies until there is proof of clinical concept; until methods to consistently produce cells are developed; and until the related business models becomes more accepted. This will likely limit the ability of smaller companies to move promising therapeutic approaches into clinical trials and eventually to patients without additional sources of funding."
Reflections on Stem Cells: Year Five
There are anniversaries and then there ARE anniversaries. In this case, Wednesday is the fifth year anniversary of George Bush's stem cell edict.
Stanford University is marking the occasion with reflections from its cadre of stem cell whizzes, including Irving Weissman, Philip Pizzo, Stefan Heller and David Magnus.
Here are some excerpts.
On the question of what would have been different if the president had remained silent:
On the most significant thing learned in the past five years:
Stanford University is marking the occasion with reflections from its cadre of stem cell whizzes, including Irving Weissman, Philip Pizzo, Stefan Heller and David Magnus.
Here are some excerpts.
On the question of what would have been different if the president had remained silent:
"David Magnus, PhD, director of the Stanford Center for Biomedical Ethics: We would have had national standards and guidelines much sooner, and we would not have been distracted by debates over the status of embryos and embryo-like constructs. We would have had to work much faster to figure out how to handle informed consent and other practical ethical challenges."
On the most significant thing learned in the past five years:
"Stefan Heller, PhD, associate professor of otolaryngology, who is investigating the use of stem cells to repair hearing damage: The past five years were key in redefining possible new approaches to find a cure for hearing loss, and stem cells played a big role in this process. We experienced the advent of stem cell-based regenerative approaches for the inner ear."
"Philip Pizzo, MD, dean of the Stanford School of Medicine and a member of the Independent Citizens' Oversight Committee for the state's stem cell institute: One of the important transitions in the past five years has been the increasing proportion of Americans who have become supportive of embryonic stem cell research. Their voice reflects a gap between the Bush administration's tenacious fixation on religious ideology and America's common-sense perspective about the value of medical research in improving the lives of adults and children. This is coupled with an increasing number of American citizens who have stepped forward to support embryonic stem cell research through philanthropy along with a rising choir of bipartisan support from the Congress. In addition, a number of states have demonstrated their support for stem cell research through either state-funded research programs or legislative activities."The most important thing to learn in the next five years:
Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine. "We will continue pushing forward on four stem cell fronts: 1) Learning how to regenerate diseased tissues using adult tissue stem cells; 2) Finding new and useful embryonic stem cell lines and the tissue stem cells they make, such as the heart and lung; 3) Finding safe, ethical ways of making stem cell lines from patients with genetic diseases that help us understand and treat those diseases; 4) Finding new therapies based on our cancer stem cell research and using our discoveries to treat Stanford cancer patients."
Thursday, August 03, 2006
Anchors Aweigh Again
The California Stem Cell Report is hoisting anchor once more. We will be offline while we make a passage across the Sea of Cortez to the mainland of Mexico from Baja California. Look for fresh reports in a few days.
Heifer Blitzes Stem Cell Coverage
The day following approval of an unprecedented $152 million embryonic stem cell research program in California, the Los Angeles Times, the state's most prestigious and largest newspaper, carried not one word on the subject – at least in its online version.
But it did have room for a story with the following headline: "Heifer Escapes at Fair, Knocks Down Pursuer."
While there is no doubt there is plenty of room for lightness in today's ponderous press, it does seem there is something a bit askew in this case in the news priorities at the Times.
The Times, however, had some company. The Sacramento Bee and the San Francisco Chronicle also failed to publish stories on the grant program. Again, this is based on a look at their Web sites. There is a possibility that stories appeared in the print version of the paper but did not make it onto the Internet. The case of the Chronicle is particularly interesting since CIRM is basically a hometown story. Its headquarters are located in the city and yesterday's Oversight Committee meeting was held in San Francisco.
We found coverage of Wednesday's CIRM Oversight Committee meeting in the San Jose Mercury News, the Oakland Tribune and the San Diego Union Tribune. The stories contained few surprises, however. Such is the case on a story with a lot of meat and all of it coming from one source – in this case, CIRM.
Here are links to the stories: Steve Johnson, San Jose; Rebecca Vesely, Oakland, Terri Somers, San Diego.
Here are links to background documents from CIRM on the grants program: Purpose and structure, Power Point presentation by CIRM President Zach Hall.
(Late breaking development: Following posting of this item, sources confirmed that the LA Times, Chronicle and The Bee did not carry stories on the grant program in their print editions.)
But it did have room for a story with the following headline: "Heifer Escapes at Fair, Knocks Down Pursuer."
While there is no doubt there is plenty of room for lightness in today's ponderous press, it does seem there is something a bit askew in this case in the news priorities at the Times.
The Times, however, had some company. The Sacramento Bee and the San Francisco Chronicle also failed to publish stories on the grant program. Again, this is based on a look at their Web sites. There is a possibility that stories appeared in the print version of the paper but did not make it onto the Internet. The case of the Chronicle is particularly interesting since CIRM is basically a hometown story. Its headquarters are located in the city and yesterday's Oversight Committee meeting was held in San Francisco.
We found coverage of Wednesday's CIRM Oversight Committee meeting in the San Jose Mercury News, the Oakland Tribune and the San Diego Union Tribune. The stories contained few surprises, however. Such is the case on a story with a lot of meat and all of it coming from one source – in this case, CIRM.
Here are links to the stories: Steve Johnson, San Jose; Rebecca Vesely, Oakland, Terri Somers, San Diego.
Here are links to background documents from CIRM on the grants program: Purpose and structure, Power Point presentation by CIRM President Zach Hall.
(Late breaking development: Following posting of this item, sources confirmed that the LA Times, Chronicle and The Bee did not carry stories on the grant program in their print editions.)
Wednesday, August 02, 2006
CIRM Approves $150 Million Grant Program
Feeding off the $150 million promised by Gov. Arnold Schwarzenegger, the California stem cell agency today authorized an ambitious program of grants aimed at "turning stem cells into cures."
The grants will back innovative ideas as well as funding laboratory facilities and equipment.
Stem Cell Chairman Robert Klein said the four-year program will "address the critical funding gap created by the paralysis of federal policy." CIRM President Zach Hall said, "We can now advance the goal set by California voters—funding the best science that leads toward therapies."
The agency issued a press release that said the program approved today will cover the following areas:
The agency also wrestled with its strategic plan and mission statement. It approved a "slogan" for its program: "Turning stem cells into cures."
The board apparently rejected suggestions to require more disclosure from scientists who review the applications for grants and make what are likely to be de facto decisions on most of them. The agency's press release said the committee approved conflict of interest regulations and made no mention of any changes from the draft presented to the panel.
Below is the full press release since it is not yet up on the CIRM web site.
The grants will back innovative ideas as well as funding laboratory facilities and equipment.
Stem Cell Chairman Robert Klein said the four-year program will "address the critical funding gap created by the paralysis of federal policy." CIRM President Zach Hall said, "We can now advance the goal set by California voters—funding the best science that leads toward therapies."
The agency issued a press release that said the program approved today will cover the following areas:
"Comprehensive Research Grants—four-year grants to investigators with a record of accomplishment in human embryonic stem cell research or closely-related field that relate to a long-term therapeutic goal;The agency said topics to be considered in the new requests for grant applications include:
"Seed Grants—two-year grants to fund innovative ideas by scientific investigators who are new to the field;
"CIRM Shared Research Laboratory Grants—grants for dedicated laboratories for culturing human embryonic stem cells including core equipment and trained personnel. Additional grants in this category will be made for a course to teach culturing methods."
"Self-renewal and differentiation of human embryonic stem cells;The preliminary grant budget approved by the agency calls for $69.5 million in the first year of the effort, declining to $20 million in the fourth year. The governor's loan is expected to cover the first two years with general obligation bonds the next two, assuming the agency prevails in court.
"Derivation of new human embryonic stem cell lines, including disease-specific lines;
"Assessment of tumorigenicity of human embryonic stem cells and derived cells;
"Reprogramming of adult human somatic nuclei;
"Studies related to identification, storage, maintenance, stability and storage of human embryonic stem cells."
The agency also wrestled with its strategic plan and mission statement. It approved a "slogan" for its program: "Turning stem cells into cures."
The board apparently rejected suggestions to require more disclosure from scientists who review the applications for grants and make what are likely to be de facto decisions on most of them. The agency's press release said the committee approved conflict of interest regulations and made no mention of any changes from the draft presented to the panel.
Below is the full press release since it is not yet up on the CIRM web site.
CIRM Press Release on Grant Program
Here is the press release from CIRM on its new grant program.
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Contact: Kirk Kleinschmidt, (415) 396-9100, kkleinschmidt@cirm.ca.gov
OVERSIGHT BOARD APPROVES PROPOSAL FOR NEW HUMAN EMBRYONIC STEM CELL RESEARCH PROGRAM
Governor Schwarzenegger-Authorized Loan Allows Science to Move Forward
San Francisco, August 2, 2006—Twelve days after Governor Arnold Schwarzenegger’s announcement of a $150 million loan to the California Institute for Regenerative Medicine (CIRM), its oversight board responded with a new proposal funding human embryonic stem cell research at California’s non-profit research institutions.
The Independent Citizens’ Oversight Committee (ICOC) approved a proposal for three Requests for Application (RFAs):
Comprehensive Research Grants—four-year grants to investigators with a record of accomplishment in human embryonic stem cell research or closely-related field that relate to a long-term therapeutic goal;
Seed Grants—two-year grants to fund innovative ideas by scientific investigators who are new to the field;
CIRM Shared Research Laboratory Grants—grants for dedicated laboratories for culturing human embryonic stem cells including core equipment and trained personnel. Additional grants in this category will be made for a course to teach culturing methods.
All grants will be made on a competitive basis to ensure that the best scientific proposals are funded. The ICOC will approve all funding decisions following scientific peer review and recommendations by the Scientific and Medical Research Funding Working Group and the Facilities Working Group, as appropriate.
“The Governor’s commitment to this science has electrified the field and given hope to millions that the promise of stem cell research will move forward in California,” said ICOC Chairman Robert Klein. “The board’s decision to focus on human embryonic stem cell research will address the critical funding gap created by the paralysis of federal policy.”
Topics to be considered in the new RFA will include but are not limited to:
Self-renewal and differentiation of human embryonic stem cells;
Derivation of new human embryonic stem cell lines, including disease-specific lines;
Assessment of tumorigenicity of human embryonic stem cells and derived cells;
Reprogramming of adult human somatic nuclei;
Studies related to identification, storage, maintenance, stability and storage of human embryonic stem cells.
“The board’s decision will allow CIRM to jump-start human embryonic stem cell research in California,” said CIRM President Zach Hall. “We have the infrastructure and policies in place to manage this exciting program in a responsible way for the people of California. We can now advance the goal set by California voters—funding the best science that leads toward therapies.”
Human Embryonic Stem Cell Research Program
Preliminary Budget
Year 1
$69.5 million
Year 2
$37 million
Year 3
$25 million
Year 4
$20 million
Total
$151.5 million
The first two years of the Human Embryonic Stem Cell Research Program is intended to be funded from the loan from the State of California initiated by the Governor. The anticipated general obligation bonds will fund years three and four of the program. An additional RFA, also to be funded by the State loan, is expected later this year to address adult, cord blood and other critical stem cell research.
The ICOC wrote a mission statement, guiding values and strategic principles for the scientific strategic plan, which is scheduled to be presented for formal approval at the next board meeting in October. The board created a slogan for the program: “Turning stem cells into cures.”
The board also approved final regulations for Medical and Ethical Standards to guide CIRM-funded research and conflict of interest regulations for advisory working group members. They will have the force and effect of California law pending final review and publication by the California Office of Administrative Law.
From Dollar Signs to Stem Cells: Diverging Views on WARF Patents
The matter is no mere piffle in Wisconsin. Just something in the neighborhood of $200 million a year from California alone, according to a story in the Milwaukee Sentinel Journal.
But out in California the issue is even greater.
"What's ultimately at stake is control of a potential billion-dollar industry that could make therapies to treat some of the world's most devastating diseases," wrote reporter Terri Somers of the San Diego Union Tribune on July 30.
What she and reporter Kathleen Gallagher of the Milwaukee paper referred to was the patent rights of the Wisconsin Alumni Research Foundation on embryonic stem cells. The two reporters raised the level of public attention to the dispute over the WARF patents with their lengthy pieces on a subject that is rarely reported by the mainstream media. Both articles were triggered by challenges to WARF by the Foundation for Taxpayer and Consumers Rights in California and the Public Patent Foundation in New York.
The stories covered some familiar ground to the readers of this blog. But we found it interesting that the Milwaukee paper cited the example of the patenting of recombinant DNA to support the WARF position while the San Diego paper cited the same patents as supporting the anti-WARF position.
Gallagher wrote on July 23:
Somers quoted Joydeep Goswami, Invitrogen vice president for stem cells and regenerative medicine, on the subject.
She reported that WARF says it has provided licenses and cells to 324 research groups at no charge" and "provided licenses and cells to 12 commercial users. Those users pay fees ranging from $75,000 to more than $250,000, plus annual royalties."
The estimate of $200 million potential revenues from California came from Gallagher's story. She attributed the figure to Peter Balbus, managing director at Pragmaxis LLC, a company in Glen Ellyn, Ill., that helps commercialize technology.
By the way, the Wisconsin State Journal in an editorial basically dismisses the WARF patent debate as a "load of bunk."
But out in California the issue is even greater.
"What's ultimately at stake is control of a potential billion-dollar industry that could make therapies to treat some of the world's most devastating diseases," wrote reporter Terri Somers of the San Diego Union Tribune on July 30.
What she and reporter Kathleen Gallagher of the Milwaukee paper referred to was the patent rights of the Wisconsin Alumni Research Foundation on embryonic stem cells. The two reporters raised the level of public attention to the dispute over the WARF patents with their lengthy pieces on a subject that is rarely reported by the mainstream media. Both articles were triggered by challenges to WARF by the Foundation for Taxpayer and Consumers Rights in California and the Public Patent Foundation in New York.
The stories covered some familiar ground to the readers of this blog. But we found it interesting that the Milwaukee paper cited the example of the patenting of recombinant DNA to support the WARF position while the San Diego paper cited the same patents as supporting the anti-WARF position.
Gallagher wrote on July 23:
"Stanford University also required upfront licensing fees on its recombinant DNA patents granted in 1980. Those fees were detailed in a paper that Maryann Feldman of the University of Toronto and two others published in November."Gallagher continued:
"Stanford's recombinant DNA patents are just as broad as WARF's.Somers in San Diego wrote:
"Stanford pulled in $254 million of revenue on the patents, which it licensed to 468 companies, including Amgen and Genentech, that developed therapeutic products such as human insulin, human growth hormone and interferons based on the technology, according to the Feldman paper."
"The WARF patents are much more expensive to use than some of the pioneering patents that have come before it – including at least one that was essential in the creation of the world's biotechnology industry.Another interesting divergence emerged concerning reach-through royalties.
"In 1980, Stanford University and the University of California system patented recombinant DNA, the process of splicing genes from one cell into another. It was one of two pivotal patents that gave birth to biotech.
"The Cohen/Boyer patents were broad in their scope, but Stanford and the UC system made a decision to license widely and cheaply to early biotech companies and to make the technology available without charge to universities and nonprofit institutes.
"Biotechnology companies grumbled at the time about having to pay $10,000 for the science, but it was much cheaper to buy the license than to fight it in court, ong>(John) Wetherell (an intellectual property attorney with Pillsbury, Winthrop, Shaw and Pittman in San Diego) said.
"The result was that more than 350 companies took licenses, the universities made $255 million and the public got the benefit of the products that were developed, (Cathryn) Campbell (an intellectual property lawyer with Needle and Rosenberg in San Diego) said."
Somers quoted Joydeep Goswami, Invitrogen vice president for stem cells and regenerative medicine, on the subject.
"WARF has what he called 'a reach-through royalty clause, where they say anything you've invented remotely by using human embryonic stem cells will now have a royalty obligation back to WARF.'Gallagher's story also noted the broader impact of the patent issue, declaring that it "signaled increasing awareness among scientists and companies that the Wisconsin Alumni Research Foundation's patents make this state the biggest interchange through which all stem cell commercialization must travel."
"For example, if Invitrogen uses embryonic stem cells early in the development of a tool for drug discovery but the production of the tool doesn't involve stem cells, WARF would still want royalties on the tool, he said.
"WARF also wants companies with licenses to pay royalties on products they sell in foreign markets that don't honor the patents, Goswami said. That would give an advantage to companies overseas, which can develop the same tools without owing money to WARF.
"(Elizabeth) Donley (WARF general counsel) denied that WARF charges the reach-through royalties, although many scientists, business executives and intellectual property experts cite them.
"The bottom line, Donley said, is that the incentive for receiving a WARF license is the ability to do business in the United States, the world's largest drug market.
"'They are building a program using our patent. You can't build a program on our patents and pay us nothing,' Donley said. 'Who has dollar signs in their eyes now?'"
She reported that WARF says it has provided licenses and cells to 324 research groups at no charge" and "provided licenses and cells to 12 commercial users. Those users pay fees ranging from $75,000 to more than $250,000, plus annual royalties."
The estimate of $200 million potential revenues from California came from Gallagher's story. She attributed the figure to Peter Balbus, managing director at Pragmaxis LLC, a company in Glen Ellyn, Ill., that helps commercialize technology.
By the way, the Wisconsin State Journal in an editorial basically dismisses the WARF patent debate as a "load of bunk."
NY Times: Stem Cell Research Funding 'Fairly Robust'...Or Is It?
The blind men and the elephant are doing their dance again. One of the participants in the latest tango is the New York Times. Others include a venture capitalist and stem cell businessmen.
Here is what the Times carried in a July 25 piece by reporter Jodi Rudoren:
A somewhat different view was expressed in California the same day the Times published its piece, according to reporter Steve Johnson of the San Jose Mercury News, who wrote about a hearing held by the California stem cell agency. Here are some excerpts:
"'This is a risky business,' said Martin McGlynn, chief executive officer of StemCells of Palo Alto, which hopes to soon begin testing fetal stem cells to help children with Batten disease, a fatal degenerative ailment.
"That risk also makes it harder for biotech companies to get funding from venture capital firms that are skittish, said Ann Hanham, managing director of Burrill & Company in San Francisco, which finances biotech companies. She said venture capitalists generally prefer to see a return on their investment in five to seven years, which is unrealistic for most stem-cell entrepreneurs.
"Bruce Cohen, chief executive of Cellerant Therapeutics of San Carlos, was one of several executives at the meeting who applauded Proposition 71.
"But given the enormous amount of work that needs to be done to turn stem cells into treatments for such ailments as diabetes and Parkinson's disease, he said, 'even with $3 billion, that's not enough.'
"Cohen urged the stem-cell institute's board to pair its taxpayer financing with money from private companies, adding, 'Prop. 71 can make a huge difference in the world if it's seen as a way to leverage private capital.'"
Of course, there are those who will never be satisfied by any amount of funding. And given the influence that the Times has, its "robust" statement could color the thinking of decision makers nationally about the adequacy of financial support for embryonic stem cell research.
Rebecca Vesely of the Oakland Tribune also covered the CIRM hearing. Here is a link to her story.
Here is what the Times carried in a July 25 piece by reporter Jodi Rudoren:
"Even with the limitations on federal financing, the overall financing available for stem cell research could be described as fairly robust, given that the research is still at a basic stage and that in addition to state money, philanthropies like the Howard Hughes Medical Institute have made contributions. Moreover, in the private sector, biotech companies like Geron, Advanced Cell Technology and Athersys conduct research on embryonic or adult stem cells."No attribution was given for that statement.
A somewhat different view was expressed in California the same day the Times published its piece, according to reporter Steve Johnson of the San Jose Mercury News, who wrote about a hearing held by the California stem cell agency. Here are some excerpts:
"'This is a risky business,' said Martin McGlynn, chief executive officer of StemCells of Palo Alto, which hopes to soon begin testing fetal stem cells to help children with Batten disease, a fatal degenerative ailment.
"That risk also makes it harder for biotech companies to get funding from venture capital firms that are skittish, said Ann Hanham, managing director of Burrill & Company in San Francisco, which finances biotech companies. She said venture capitalists generally prefer to see a return on their investment in five to seven years, which is unrealistic for most stem-cell entrepreneurs.
"Bruce Cohen, chief executive of Cellerant Therapeutics of San Carlos, was one of several executives at the meeting who applauded Proposition 71.
"But given the enormous amount of work that needs to be done to turn stem cells into treatments for such ailments as diabetes and Parkinson's disease, he said, 'even with $3 billion, that's not enough.'
"Cohen urged the stem-cell institute's board to pair its taxpayer financing with money from private companies, adding, 'Prop. 71 can make a huge difference in the world if it's seen as a way to leverage private capital.'"
Of course, there are those who will never be satisfied by any amount of funding. And given the influence that the Times has, its "robust" statement could color the thinking of decision makers nationally about the adequacy of financial support for embryonic stem cell research.
Rebecca Vesely of the Oakland Tribune also covered the CIRM hearing. Here is a link to her story.
San Jose Merc: Full Disclosure Needed from CIRM
The stakes are large and the temptations are great. The evidence also shows that some scientists and physicians cannot resist – perhaps only a tiny handful, but nonetheless a significant number.
What we are talking about is the linkage between corporate interests and medical research. Reporter Paul Jacobs of the San Jose Mercury News is only one of the latest to report the bountiful ties binding the two in his recent look at Stanford University.
The newspaper editorialized on the subject and the California stem cell agency on Monday before today's meeting of its Oversight Committee.
Here is an excerpt:
What we are talking about is the linkage between corporate interests and medical research. Reporter Paul Jacobs of the San Jose Mercury News is only one of the latest to report the bountiful ties binding the two in his recent look at Stanford University.
The newspaper editorialized on the subject and the California stem cell agency on Monday before today's meeting of its Oversight Committee.
Here is an excerpt:
"California's great stem-cell experiment faces a moment of truth this week.
"Wednesday, in San Francisco, the state's stem-cell institute must make a pivotal decision on whether members of its working groups should be required to publicly disclose any conflicts of interest before they review grant applications and make recommendations to the agency's governing board for final approval.
"The agency should make an investment in public oversight and public confidence and overturn its staff's recommendation opposing full public disclosure.
"The arguments opposing full disclosure have merit. There is concern about whether top-level scientists will be willing to participate in the process if they have to make complete financial disclosures of any potential conflicts. The working groups are strictly voluntary and will require a substantial time investment by out-of-state scientists who must be experts in their field. The disclosure provision could discourage some from participating. So the agency wants to settle for internal disclosure of potential conflicts that could then be reviewed, but not publicly disclosed, by the Legislature or an independent auditor.
"But as Mercury News Staff Writer Paul Jacobs pointed out in a recent series, the relationship between medical companies and premier research universities is growing increasingly cozy, and many professors now have second jobs working for medical firms.
"Public confidence in California's $3 billion investment outweighs the importance of attracting the highest level of scientists to review applications. The scrutiny over who receives the stem-cell research grants is certain to be intense over the course of the next decade. The last thing the state agency needs is a lawsuit or scandal over how it is spending taxpayer dollars. Anything less than full disclosure is bound to invite skepticism about the agency's integrity."
Stem Cell Snippets: Brits, Maryland and Defining the Debate
Links to interesting stories and other items connected to California stem cell issues.
Blair Hobnobs – The visit of Great Britain's PM to California highlighted linkages with the state's stem cell community. Participants in the meetings included Zach Hall, president of CIRM. Brits say they are spending $186 million for stem cell research in the next two years, substantially less than what California is supposed to be doing. It is not clear whether the British funding is for ESC research only or all stem cell research. The stories do not mention that the British consulate in SF has a man assigned to tracking developments at CIRM. You can find the San Francisco Chronicle story here and the San Jose Mercury News story here.
Chirping from Chesapeake – From Maryland comes word that it intends to outstrip California in giving grants for stem cell research, despite having only $15 million to play with. Linda Powers, biotech venture capitalist(Toucan Capital) and chair of the Maryland stem cell commission, stated that goal in a piece in the Washington Business Journal.
Classifying Stem Cell News – What type of news is a report about a stem cell matter – science, medicine, business, politics, governmental? Kaiser Permanente, the mammoth healthcare enterprise, says it is women's health news. That's where they put a summary of stem cell related opinion pieces. Not important, you say. Perhaps to some. But if stem cell research is, for example, considered mainly religious news, a reader might come to a different conclusion than if he or she thought it was a health subject. Defining the debate is still critical to building support for embryonic stem cell research. As for Kaiser's classification, it is entirely appropriate to describe stem cell news as a women's issue, but it is obviously more as well.
Blair Hobnobs – The visit of Great Britain's PM to California highlighted linkages with the state's stem cell community. Participants in the meetings included Zach Hall, president of CIRM. Brits say they are spending $186 million for stem cell research in the next two years, substantially less than what California is supposed to be doing. It is not clear whether the British funding is for ESC research only or all stem cell research. The stories do not mention that the British consulate in SF has a man assigned to tracking developments at CIRM. You can find the San Francisco Chronicle story here and the San Jose Mercury News story here.
Chirping from Chesapeake – From Maryland comes word that it intends to outstrip California in giving grants for stem cell research, despite having only $15 million to play with. Linda Powers, biotech venture capitalist(Toucan Capital) and chair of the Maryland stem cell commission, stated that goal in a piece in the Washington Business Journal.
Classifying Stem Cell News – What type of news is a report about a stem cell matter – science, medicine, business, politics, governmental? Kaiser Permanente, the mammoth healthcare enterprise, says it is women's health news. That's where they put a summary of stem cell related opinion pieces. Not important, you say. Perhaps to some. But if stem cell research is, for example, considered mainly religious news, a reader might come to a different conclusion than if he or she thought it was a health subject. Defining the debate is still critical to building support for embryonic stem cell research. As for Kaiser's classification, it is entirely appropriate to describe stem cell news as a women's issue, but it is obviously more as well.
Saturday, July 22, 2006
Busy Agenda for CIRM Oversight Committee in August
The California stem cell agency will wrestle with everything from intellectual property and open access to research findings to its $150 million bailout and conflicts of interest at meetings of its Oversight Committee Aug. 1-2 in San Francisco.
Background documents are not yet available on CIRM's Web site – only the barebones agendas. We expect to see them filled with links to additional information as the dates of the meetings near.
The public will have a fine opportunity to weigh in on CIRM's strategic plan for giving away $3 billion. A three-hour evening session is set to begin at 7 p.m.
Here are links to the agendas for each day's meeting: Aug. 1, Aug. 2.
Background documents are not yet available on CIRM's Web site – only the barebones agendas. We expect to see them filled with links to additional information as the dates of the meetings near.
The public will have a fine opportunity to weigh in on CIRM's strategic plan for giving away $3 billion. A three-hour evening session is set to begin at 7 p.m.
Here are links to the agendas for each day's meeting: Aug. 1, Aug. 2.
Anchors Aweigh for the California Stem Cell Report
As most of you know, this report comes to you from a sailboat in Mexico, which moves about from time to time. When that happens we lose contact with the civilized world and the Internet. So over the next eight days or so, you are not likely to have fresh grist to savor – at least from this Web site. We expect to be back online about the time of the Aug. 2 meeting of the Oversight Committee.
For the sailors among you, the boat is called Hopalong. He/she is a 39-foot Freedom, cat-rigged ketch (1984 vintage) with freestanding, carbon fiber masts. Hopalong is our only home. We have given up the dirt life.
Look for more exciting news and commentary on California stem cell affairs on Aug. or thereabouts.
For the sailors among you, the boat is called Hopalong. He/she is a 39-foot Freedom, cat-rigged ketch (1984 vintage) with freestanding, carbon fiber masts. Hopalong is our only home. We have given up the dirt life.
Look for more exciting news and commentary on California stem cell affairs on Aug. or thereabouts.
Ortiz Measure Stripped of Ban on Reimbursement of Lost Wages
Legislation aimed at protecting women who donate eggs for stem cell research has been amended to eliminate a prohibition against reimbursement of lost wages.
The measure, SB1260 by Sen. Deborah Ortiz, D-Sacramento, is now before the Assembly Appropriations Committee. It applies only to stem cell research not funded by the California stem cell agency.
At one point, Ortiz argued that reimbursement of wages should be barred because of the potential inequities involving women in lower paying positions and women in more highly paid occupations.
The bill continues to bar payments to donors except for "direct expenses incurred as a result of the procedure." The measure now appears to conform more closely to regulations approved by the California stem cell agency.
Hank Greely, chairman of the advisory committee on stem cell research with the California Department of Health Services, said the bill will be the starting point for his committee's recommended guidelines for stem cell research, expected later this year.
Greely, a Stanford law professor, said he interpreted the latest language of SB1260 as permitting reimbursement for lost wages although he said it could be argued "the other way."
Our thanks to Greely for pointing out the amendment in the measure.
The measure, SB1260 by Sen. Deborah Ortiz, D-Sacramento, is now before the Assembly Appropriations Committee. It applies only to stem cell research not funded by the California stem cell agency.
At one point, Ortiz argued that reimbursement of wages should be barred because of the potential inequities involving women in lower paying positions and women in more highly paid occupations.
The bill continues to bar payments to donors except for "direct expenses incurred as a result of the procedure." The measure now appears to conform more closely to regulations approved by the California stem cell agency.
Hank Greely, chairman of the advisory committee on stem cell research with the California Department of Health Services, said the bill will be the starting point for his committee's recommended guidelines for stem cell research, expected later this year.
Greely, a Stanford law professor, said he interpreted the latest language of SB1260 as permitting reimbursement for lost wages although he said it could be argued "the other way."
Our thanks to Greely for pointing out the amendment in the measure.
Stem Cell Snippets: Hear Arnold and Jesse
News, press releases and other information on California stem cell issues.
The stem cell bailout – You can see and hear Gov. Schwarzenegger, California stem cell chairman Robert Klein and vice chair Ed Penhoet announcing the $150 million loan at this location. A transcript is available if you don't want to wade through the video.
Jesse Reynolds of the CGS on the loan – Marc Strassman of California Politics Today has an audio critique of the loan from Jesse Reynolds of the Center for Genetics and Society. No transcript is available.
The stem cell bailout – You can see and hear Gov. Schwarzenegger, California stem cell chairman Robert Klein and vice chair Ed Penhoet announcing the $150 million loan at this location. A transcript is available if you don't want to wade through the video.
Jesse Reynolds of the CGS on the loan – Marc Strassman of California Politics Today has an audio critique of the loan from Jesse Reynolds of the Center for Genetics and Society. No transcript is available.
CIRM Guide to Comments on IP Rules
In a useful and comprehensive document, the California stem cell agency has synthesized comments on its rules for sharing the wealth from inventions that result from CIRM-funded research by nonprofit institutions.
The report organizes and boils down lengthy criticism of the proposed regulations. Included are staff comments and annotations to specific locations in nearly 200 pages of comments and previous transcripts of CIRM hearings. The 10-page document also provides a guide to some of the thinking at CIRM that could well extend to rules for intellectual property involving grants to business.
The summary was prepared for a lightly covered hearing earlier this month during which the IP Task Force adopted some of the recommendations of biotech businesses. Those changes will go before the Oversight Committee on Aug. 2 in a hearing that is likely to refer once again to the analysis of the comments.
The summary is a bit unusual for CIRM. With some exceptions, it has not regularly or consistently produced background documents that organize and attempt to place policy issues in an accessible context. However, increasingly the agency seems to be heading in that direction, a move that well serves both the agency and its constituent publics – academia, business, California and national policymakers as well as the general public.
The report organizes and boils down lengthy criticism of the proposed regulations. Included are staff comments and annotations to specific locations in nearly 200 pages of comments and previous transcripts of CIRM hearings. The 10-page document also provides a guide to some of the thinking at CIRM that could well extend to rules for intellectual property involving grants to business.
The summary was prepared for a lightly covered hearing earlier this month during which the IP Task Force adopted some of the recommendations of biotech businesses. Those changes will go before the Oversight Committee on Aug. 2 in a hearing that is likely to refer once again to the analysis of the comments.
The summary is a bit unusual for CIRM. With some exceptions, it has not regularly or consistently produced background documents that organize and attempt to place policy issues in an accessible context. However, increasingly the agency seems to be heading in that direction, a move that well serves both the agency and its constituent publics – academia, business, California and national policymakers as well as the general public.
Bush's 'PR Wonders'
California supporters of embryonic stem cell research like to point to polls that seem to show that most Americans support the effort. This past week was a case study of how that translates into reality. Another take on who won the PR battle can be found on this interesting blog by Matthew C. Nisbet, a communications teacher at Ohio State.
Here is the headline:"ON STEM CELL BILLS, BUSH & CO. WIN THE BATTLE OF THE VISUAL: SC Proponents Worked PR Wonders to Get This Far, But the Power of the Bully Pulpit Is Hard to Beat; Embryo Research is Transformed Visually Into Research on 'Young Humans'"
We say that polls "seem" to show majority support for ESC research because polls can be easily manipulated. Some of these polls are funded by ESC organizations, which are not likely to pay for results that do not support their position. At some point in the future, we will discuss in more detail the reasoning behind our belief that support for ESC is probably weaker than supporters believe.
Here is the headline:"ON STEM CELL BILLS, BUSH & CO. WIN THE BATTLE OF THE VISUAL: SC Proponents Worked PR Wonders to Get This Far, But the Power of the Bully Pulpit Is Hard to Beat; Embryo Research is Transformed Visually Into Research on 'Young Humans'"
We say that polls "seem" to show majority support for ESC research because polls can be easily manipulated. Some of these polls are funded by ESC organizations, which are not likely to pay for results that do not support their position. At some point in the future, we will discuss in more detail the reasoning behind our belief that support for ESC is probably weaker than supporters believe.
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