Thursday, August 31, 2006
The Democrat from the Los Angeles area (Redondo Beach) defeated the author of the egg bill (SB1260), Sen. Deborah Ortiz, in the June primary in the race for the Democratic nomination for California secretary of state.
We asked Bowen's office for a statement on the negative vote. Here is the verbatim comment from Bowen:
“I am concerned that prohibiting women from being paid for their eggs or for participating in research singles them out from how other medical research subjects are treated. That, in turn, is likely to reduce the number of women who can or will take part in embryonic stem cell research.”
See the item below for more on the bill itself.
Ortiz was an early and influential figure in California stem cell issues. The Sacramento Democrat carried legislation in 2002 that made California the first state in the nation to authorize embryonic stem cell research. She is credited by some with originating the idea of taking a stem cell initiative to the ballot in California, which ultimately was the mechanism that created the California stem cell agency.
Her egg donor bill went to the governor today on a 34-1 vote in the California State Senate when it concurred in Assembly amendments to the measure – SB1260.
Ortiz' office issued a press release that quoted the legislator, who is being termed out, as saying:
“Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans. We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.”The bill also lays the groundwork for regulation of embryonic stem cell research in California – outside of that funded by the California stem cell agency, which operates under a unique initiative measure that does not permit the legislature or the governor to fiddle with its procedures or funding.
Ortiz' measure also was drafted to be consistent with the existing regulations of the stem cell agency. Implementation of the measure is through the Department of Health Services. Currently an advisory committee is in the process of drafting proposed regulations. Its next meeting is Sept. 20 in Berkeley.
Here is a link to the latest legislative staff analysis of the bill. Here is a link to the bill.
(For those of you unfamiliar with American political terminology, "termed out" means that she is leaving office as the result of a law that limits the number of terms that a person can serve in a particular position.)
However, the measure (SB1260) by Sen. Deborah Ortiz, D-Sacramento, has drawn fire from two UCLA law professors who argue that it "threatens the future of stem cell research" in California because it would bar payment for eggs.
Russell Korobkin and Judith Daar criticized the bill as "shortsighted" in an op-ed piece in the Los Angeles Times.
Here are some excerpts:
"The primary justification offered for banning compensation to egg donors is that financial incentives will unduly induce women, particularly those of lower socioeconomic status, to undergo egg extraction without fully considering the significant risks and inconveniences associated with the weeks-long process, which requires hormone injections and minor surgery. Money, it is argued, will enable overzealous scientists to coerce women to become egg providers.Whatever the strength of their argument, it comes much too late to have an impact on the measure. It is also not likely to be cited during debate on the Senate floor. Paying egg donors is not a political third rail, but few, if any legislators are likely to support such a move.
"This argument relies on an unusual and indefensible view of what constitutes coercion. In a free-market economy, financial inducements are ubiquitous, especially when socially valuable activities entail some degree of risk or inconvenience. Coal mining is dirty and dangerous work, but we don't claim that paying miners is coercive and expect altruists to do the job for free. Certainly there is no movement afoot to ban payments to soldiers or peace officers in the name of protecting them against placing themselves in harm's way for profit. In fact, just the opposite. We sometimes provide extra hazard pay to public servants who take on the greatest risks in recognition of their valuable contributions.
"If anything, ethics requires the affirmative compensation of individuals who sacrifice so that the rest of us can reap the benefits of biomedical research. Medical research subjects commonly are paid a fee for their participation. There is no justification for ushering women of reproductive age into a separate and wholly unequal category — ineligible for compensation solely because of the nature of their research participation."
Here is a link to the analysis of SB1260 prepared for use in the Senate floor debate on the bill.
Wednesday, August 30, 2006
California biomedical firms objected to the previous language. The latest version was hammered out a meeting of the Task Force following comments from its members and others.
The new language, which will be posted on the CIRM website as part of the administrative rules procedures, stipulates that grantees make CIRM-funded patented inventions "readily accessible on reasonable terms to other grantee organizations."
Some members of the Oversight Committee, in addition to the business groups, were concerned that the previous language (known as the Research Use Exemption - RUE) would remove incentives to market and distribute useful research tools.
Janet Lambert, director of government relations for Invitrogen of Carlsbad, Ca., flew out from Washington, D.C., to present her company's point of view. She and others, including John M. Simpson, stem cell director of the Foundation for Taxpayer and Consumer Rights, worked out the compromise language in the rear of the room as the Task Force dealt with other issues.
Part of the backdrop for discussion for the language was "The WARF Problem." Repeatedly speakers said they did not want to emulate the example of the Wisconsin Alumni Research Foundation, which holds key patents to embryonic stem cells. The foundation has been the subject of sharp criticism for failing to allow use of the patents more widely and less expensively.
CIRM President Zach Hall argued for wider distribution of CIRM-funded research. He said he did not want to see a situation where "we can't communicate with our (scientific) neighbors."
Members of the Task Force. Including Jeff Sheehy, also raised questions about how the previous language was arrived at and the process of involving "stakeholders" in discussions. Sheehy said he was "very uncomfortable" about a discussion process that would seem to favor some stakeholders over others.
Once the new language is officially published, that will trigger another 15-day comment period. You can see details of the administrative rules process here.
The item should have said that the multiple being considered was a multiple of total CIRM funding. For example, if the CIRM funding is $1 million, the return could be $3 million to $5 million.
Our thanks to the CIRM staff for pointing out the error.
Tuesday, August 29, 2006
Attention California stem cell businesses. Here's the deal. Or at least almost the deal.
But if you want cash from the California stem cell agency, you better listen up. And if you want to shape the rules for sharing the swag, now the time is to make your voice heard. It could be a done deal by this time next month.
On Tuesday afternoon, beneath replicas of a couple of twin-engine aircraft, the CIRM Task Force on Intellectual Property approved principles for handling IP generated as a result of CIRM grants to business. Hundreds of millions of dollars could be handed out to California stem cell businesses over the next few years, but oddly few were represented at the hearing at the aviation museum at San Francisco International Airport. A number have testified in the past, however.
Two key areas involved payments by grantee businesses to the state and creation of plans to help uninsured Californians and provide low cost access to CIRM-funded stem cell therapies.
The Task Force approved requiring a business that chooses to license a CIRM-funded invention to a third party to abide by the same requirements as for nonprofits except for the size of the share of any returns. Instead of the 25 percent sharing requirement (after $500,000) for nonprofits, the task force chose 17 percent. The Task Force initially called for the 17 percent to be shared out of "revenues" from the invention. However, questions were raised concerning the definition of revenues, and its meaning will be considered again later.
If the grantee chooses to develop a product themselves, the state would receive some sort of multiple of CIRM funding after the "success" of the product. Discussion seemed to favor a multiple in the 3 to 5 percent range, leaning strongly to the lower end.
The Task Force also approved a requirement that some businesses develop plans to provide access to CIRM-funded therapies to the uninsured and to provide them to public agencies at the federal Medicaid price. The plan requirement would be triggered when CIRM funding represents more than a yet-to-be determined percent of the invention.
Other principles approved include:
Ownership of the IP by the grantee.
Onetime "blockbuster" payments by the grantee after revenues exceed a yet-to-be-determined level.
Sharing of "publication-related," CIRM-funded biomedical material as in the nonprofit policy.
IP Task Force member Duane Roth told the group that it needs to set clear rules on IP. Businesses need certainty, he said. They need a "real clear matrix, that this is the deal."
The "deal" will come up again, possibly in September, preceding CIRM's Oversight Committee meeting in October. CIRM staff will craft IP policy rules based on Tuesday's discussion and bring them back to the Task Force. Ed Penhoet, chair of the Task Force, said he wants to present an IP policy for businesses to the Oversight Committee for action next month.
We will have more on the IP meeting in the next few days. And, by the way, the Task Force held its meeting in the aviation museum because it was free space provided as a result of San Francisco's bid to obtain the CIRM headquarters.
(Correction on the above item: The 5th paragragh contains an incorrect figure. It should have said that the multiple being considered was a multiple of total CIRM funding. For example, if the CIRM funding is $1 million, the return could be $3 million to $5 million. We incorrectly reported that the multiple being considered was in the 3 to 5 percent range.
(Our thanks to the CIRM staff for pointing out the error.)
A research use exemption (RUE) allows researchers to use patented
inventions without obtaining licenses and paying license fees, royalties
and other payments to the inventor. Courts have recently concluded that
contrary to widely held belief, there is no automatic research use
exemption under U.S. patent law. Many universities and non-profit
institutions, however, frequently allow other academic researchers to
use patented inventions for non-commercial research without paying the
university or institution any fees. This has not been the case with
human embryonic stem cell (hESC) research. The holder of the very broad
patents over human embryonic stem cells and the core process for
creating them, the Wisconsin Alumni Research Foundation (WARF), insisted that all academic and non-profit researchers pay substantial license
fees for the right to experiment with hESC or to create new hESC lines.
CIRM initially adopted an RUE as one of its core Intellectual Property principles. CIRM stated that it sought to "ensure broad access for
California research institutions to patented inventions made under CIRM
funding for research purposes through a research exemption." CIRM
stated in its original discussion of its IP Rules that a research
exemption would "promote the advancement of research and medical
therapies through broad use of patented inventions developed under CIRM
funding . . . . This policy will allow researchers to experiment
with state-of-the-art technology generated as a consequence of CIRM
funding without constraints which might otherwise apply under patent
CIRM unexpectedly dropped the RUE after several industry representatives
objected to it. This move has surprised and concerned a number of
independent observers in light of the strong arguments CIRM advanced in
favor of the RUE up to the point of eliminating it. By not guaranteeing
that CIRM funded non-profit grantees will allow free use of CIRM funded
inventions for non-commercial research, CIRM opens the door for a repeat
of the problems WARF created in its licensing policies. Under CIRM's
latest proposal, scientists at a California university could receive a
large CIRM grant and make a path-breaking invention, such as
"reprogramming" adult cells to behave like stem cells (currently done
through cloning in animals), and then require that each academic or
non-profit researcher in California who wishes to make or use such
"reprogrammed" cells pay the university $10,000 (or more) annually for
the right to do so. This is why proponents of the RUE have complained
that CIRM's new position can require CIRM, and the California taxpayers,
to pay twice (or multiple times) for the research discoveries made under
CIRM grants. Of course, what is worse, is that under this scenario many
researchers would be unable or unwilling to pay the licensing fees and
stem cell scientific advances (and resulting therapies) would be further
A RUE that would address many of industry concerns, and in fact reflect
the "good citizen" practices of many universities today (practices
incidentally that industry readily accepts) would simply provide that
"CIRM Grantee organizations shall allow Non-Profit Organizations,
without payment, to practice CIRM-funded patented inventions in
California for any non-profit purpose."
Monday, August 28, 2006
Another remote location has been added for the meeting, this one in Elk Grove, Ca., south of Sacramento.
Will ACT save embryonic stem cell research? No way.
Advanced Cell Technology's announcement in Nature last week wound up the rhetoric—yet again—surrounding embryonic stem cell research. The Alameda, California, company claims an embryonic stem cell line can be made without harming a human embryo. The ACT technique is modeled after an in vitro fertilization (IVF) diagnostic test called PGD. The test plucks one cell out of a two day-old embryo containing eight cells or so. The cell’s DNA is screened for dozens of deadly diseases. If the test is positive, the embryo is discarded. If no disease genes are detected, the embryo—which quickly makes a new cell to replace the missing one—is implanted. The procedure seems safe: more than a thousand children have been born since the test was unveiled in the early 1990’s.
From a scientific perspective, the ACT paper is interesting, but not groundbreaking. The researchers repeated a method they perfected earlier in mice using human cells; that’s no mean feat. They claim the type of cell they used—called a blastomere—produced an embryonic stem cell line. If other labs can repeat the result and if the lines can make different, functional cell types, that's pretty cool.
But the thing that has tongues wagging is what happens to the embryo. Until now, embryos must be killed in order to make an embryonic stem cell line, a process opponents equate to murder. Here, finally, seems to be a way around the moral morass. Removing one cell to make a cell line causes no ill effects, embryo-wise. Robert Lanza, who led the ACT group, said, "This will make it far more difficult to oppose this research.”
Problem solved? Not by a long shot. Scientists are already picking apart the ACT results. It isn't clear what stage of embryo was used, and the embryos didn’t survive because Lanza’s method removed all the blastomeres, rather than just one. Most of the cells failed to do anything at all, hinting that some are better than others at generating a line. Finally, the embryos used represent a narrow genetic range: most couples who frequent IVF clinics are Caucasian and infertile.
The ethical ‘solution’ is pretty much a non-starter. Religious conservatives who believe that an eight-cell corpuscle is a human being with rights, object to anything that treads on those rights, especially a technique that sucks out one-eighth of its biological material. Hard-line Catholics argue that the blastomere itself is a person simply because it has the potential to become one. Imagine a cell kicking and screaming on the way to a Petri dish, and you get the idea.
A reporter asked me what this means for California stem cell research. The moral hairsplitting and rickety nature of frontier science are just two of many reasons why the California Institute of Regenerative Medicine mustn’t lose focus on proven methods used to derive embryonic cell lines. The ACT result must stand the test of time and be compared to other technologies and new discoveries. Who knows which will work the best for therapies? We need hundreds of laboratories, thousands of lines, and millions of dollars to find out.
Sunday, August 27, 2006
So says patent lawyer Lawrence B. Ebert (sort of), who takes serious exception to a piece in the Sacramento newspaper about WARF and the ACT techniques widely reported last week.
In language that we will not repeat here, Ebert declared that The Bee and those it quoted are wrong about how the ACT technique might affect WARF patents.
The California Healthcare Institute, BIOCOM, five different California-linked biomed firms and a national group, BIO, all filed objections last week to various aspects of the proposed intellectual policy regulations, which are up for discussion on Tuesday.
Arrayed against them virtually alone was the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., which said:
"In essence, taxpayers ought not to pay for the same research twice, and research institutions that they fund should not be prevented from non-commercial access to publicly funded research."The foundation referred to the controversy over an IP provision that would allow California research institutions to use CIRM funded inventions at no cost. But the California Healthcare Institute, which represents the state's biomedical industry, also objected to attempts to provide CIRM-funded therapies at low cost and to provisions for the state to receive roughly 25 percent royalties on CIRM-funded inventions.
David Gollaher, president of the institute, said aspects of the proposed regulations "present unnecessary, improper or overly burdensome requirements likely to undermine the commericail collaboration necessary for the development of new products."
Lila Feisee, managing director of BIO, wrote that "damaging provisions" in the IP rules place CIRM in the position of "standing in the way of the goals it seeks to achieve."
A key item for the businesses is a change in language involving what is known as the research use exemption. In July, the businesses said, the CIRM IP Task Force removed language that would have would have required grant recipients to allow California research institutions use CIRM-financed inventions for research purposes at no cost."
The IP group deleted the provision after business groups objected that it would remove incentives to develop commercial research tools. Somehow similar language has crept back into the proposed rules, in a move that "appears to contradict the public record," according to a letter signed by Applied Biosystems, BIOCOM, Invitrogen Corp., Isis Pharmaceuticals, Sangamo Biosciences and Target Discovery.
Joydeep Goswami, vice president of stem cells and regenerative medicine for Invitrogen, warned that taxpayers should not have to pay "four times" for use of CIRM research.
"If licensing is made unattractive by overbroad...patent protection carve outs, taxpayers will pay four ways: First, they will fund the development of the invention; second, they will have to pay for the development and distribution of the IP; third, they will pay for the royalty revenues lost to the state because the IP has not been commercialized, and finally, they will suffer the costs of not getting research tools and therapeutics to researchers an patients as rapidly and effectively as possible."John M. Simpson, stem cell director of the taxpayer foundation, told the California Stem Cell Report:
"While we might like to think that universities are benevolent and act in the broad public interest, you just need to look at the way the Wisconsin Alumni Research Foundation is asserting its stem cell patents to understand this isn't so.Simpson also spoke to the issue of IP for businesses:
"I think administrators at California institutions are just as likely to be blinded by dollar signs in their eyes as those in Wisconsin.
"We need a research use exemption. It's possible to craft one that meets biotech's concerns and fulfills the vital public interest of keeping all publicly funded research available to other researchers."
"For-profit IP regulations are going to be much more difficult to craft because there is a greater possibility of abuse.On Tuesday, the IP Task Force is scheduled to meet in San Francisco, with remote sites in Los Angeles, Stanford and Irvine, to discuss both non-profit and for-profit regulations. Here is the Task Force Agenda.
"Funds will almost certainly be given for projects that are much closer to developing products for commercialization and clinical use than is the case with grants to universities and nonprofit institutions.
"That means it's imperative that provisions in the for-profit IP regulations guarantee access and affordability for all Californians to any drugs and cures that are developed as a result of Prop 71 funding to companies. There must be a provision that prevents unfair, egregious profiteering."
Reporter Steve Johnson of the San Jose Mercury News prepared a piece on the business of ACT late last week. He quoted on William Caldwell, CEO of ACT, as being "very optimistic" on his enterprise. Johnson wrote:
"Advanced Cell Technology disclosed that it expects to get $13.5 million in funding from investors. Moreover, the company next year plans to seek federal approval to begin studies in people of its proposed stem-cell treatment for macular degeneration, an eye disease."Johnson continued:
"The firm has consistently lost money since its inception and last year reported a net loss of $9.4 million. Its revenue from licensing fees and royalties totaled $395,007.(As for that island business in the first paragraph of this item, it is not widely known that the city of Alameda is on an island in San Francisco Bay. We report that as part of our effort to educate the public about important geographic issues. We are also fond of interesting minutia.)
"Consequently, it has resorted to unusual tactics to save
"When it public last year, for example, it didn't use the usual method of doing an initial public offering. Instead, it chose the cheaper route of taking over an existing public company, acquiring Two Moons Kachinas, which sold kachina dolls used in American Indian ceremonies. Advanced Cell Technology then changed Kachina's stock symbol and is traded on the over-the-counter bulletin board as ACTC.OB.
"Despite a huge jump in its stock price after Wednesday's announcement, the company's stock has fallen from a high of $2.95 a share on Oct. 17 last year to 96 cents at the close of trading Friday. Its future remains murky."
And that one time came on Saturday when Monsignor Elio Sgreccia, No. 1 in the Vatican on bioethical questions, gave a thumbs down to Advanced Cell Technology's latest development on extraction of embryonic stem cells.
ACT should capture the good monsignor's pronouncement and emblazon it on the walls of their headquarters in Alameda, Ca., which is a city on an island in San Francisco Bay.
Friday, August 25, 2006
Salary—Earlier, we indicated we would bring you the salary of the new chief communications officer at CIRM. The range for the position is $130,000 to $195,000. He is receiving $180,000.
Strategic Plan – Interviews conducted during the stem cell plan process now stand at 69 and appear to be nearly complete. Here is the list. Here is a rundown on the events and number of persons involved.
IP – The Wellcome Trust, a nearly $20 billion charity in Great Britain funding biomedical research, will be on the agenda next Tuesday at CIRM's latest IP meeting, including its revenue sharing and funding agreements. Also added to the agenda is consideration of "pertinent public comment" on nonprofit IP policy.
Conflicts – Jesse Reynolds of the Center for Genetics and Society criticizes the Connecticut stem cell effort for conflicts of interest, pointing to California as an example not to be emulated.
Reporter Jim Downing of The Sacramento Bee quoted Stanford law professor Hank Greely as saying:
"The mere fact … of having a new way to make embryonic stem cells weakens the WARF patents, which I think is a good thing."Downing continued:
"Greely said that the main complaint with the Wisconsin patents is how the foundation has chosen to enforce them.Downing reported that WARF did not respond to two requests for comment. However, the Wisconsin Technology Network did have a general reaction from WARF in a piece by Joe Vanden Plas.
"'Stanford and UCSF have the seminal genetic engineering patent, and they … quite cleverly, had very lenient license terms for non-universities -- a relatively small cash amount and a small royalty,' Greely said. 'And the result was, the technology went everywhere and those two universities made a lot of money.'
"By contrast, he said, 'WARF is making enemies.'"
"Andrew Cohn, a spokesman for WARF, said the new method of deriving stem cells should not hurt Wisconsin's standing as a leader in stem-cell research. He also said WiCell, the nation's first stem-cell bank and a subsidiary of WARF, would be interested in helping distribute stem cell lines derived from this method.
"He also said it's too early to tell how the new method would impact WARF's stem cell patents. 'We don't even know what they claim in their patents, but that's the last thing we're concerned about,' Cohn said. 'We need time to dissect and digest its full impact.'"
Martin McGlynn, president of StemCells, Inc., of Palo Alto, gave this response:
"I would ask CIRM to clearly define success. Publish a road map to achieve those successes. I would offer two thoughts as to what you might deem success. I look to the notion of what happens when the party is over....:McGlynn was among a number of private sector folks who discussed strategic planning issues last month with CIRM. Their comments are summarized in a 40-page document now available on the Web. The summary adds considerable meat to the skimpy bones of their Power Point presentations.
"There would be Centers of Excellence in the state with a critical mass of world-class talent and a proven track record or diversity at each center in its chosen field of endeavor.
"You would have created a vibrant, sustainable for-profit sector that focuses on applied research and the translation of discoveries into use for the benefit of mankind. Those entities by then should be fundable by more traditional sources of funds.
"The cycle time for the work that needs to be done is twice what VCs wants to see, so get out of blocks quickly, leverage your dollars, and make sure you are the first money to accomplish your mission."
Here are a few more excerpts.
Bruce Cohen, president and chief executive officer, Cellerant Therapeutics of San Carlos, Ca., on CIRM's goals:
"The taxpayer needs to see a return on this investment. You need to find a way for them to see company and job creation, which will come sooner than cures for some of the debilitating disease we are trying to address. So we need to encourage capital to come in to accelerate new businesses and let existing businesses get bigger.Sumit K. Chanda, group leader,, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation, on core facilities:
"You also need to get therapies into the clinic so voters will see a potential change in their lives. You need to accelerate the process by which adult and embryonic stem cells therapies find their way to people. Even if it's an inconclusive Phase I trial, you'll be happy someone with state funding is trying to accelerate the process.
"It's those two things that will make people who voted for this appreciate what’s been done on their behalf."
"We have started to get into a little bit of stem cell screening. These are the major challenges and possibilities that we have seen using high-throughput screens using stem cells:Chanda continued on the subject of cultural roadblocks.
"One of the possible solutions that I am proposing is a core facility for screening where everyone in California who is interested in running high-throughput stem cell screens can go. This would be parallel to the NIH roadmap project where they had the MLSCN [Molecular Libraries Screening Centers Network] centers located in different areas in the States.
"The only exception I would make to this is that the NIH had the centers run by academic groups. It is really the private sector that has been making advances in screening in the last 20 years or so, so it might make more sense to have the private sector spearhead a screening facility."
"We have found that there are culture roadblocks between the academic and biotech sectors, even though we have pretty good relationships with various academic groups. We find that the collaborations are very fruitful, but most of our knowledge of what is going on from academic groups comes from publications, which usually do not give you enough information and often occur a couple of years later than the initial discovery."Ann F. Hanham, managing director, Burrill & Company of San Francisco on "concerns:"
"How much more basic research is going to need to be done? Many of the companies that pitch to our firm are not ready for VC funding yet. They have not worked up their business metrics or their technology or their idea or how much time/resources they need to get to a final product.Thomas B. Okarma, president and chief executive officer, Geron Corp. of Menlo Park, Ca.
"Patents are a huge issue for VCs. We need to protect our investment. If we are going to put capital in, we need to ensure protection of that asset. The University of Wisconsin patents have raised issues about whether we can invest in this field.
"We also need to see a commercialization strategy. Right now, stem cell science is much more on the research side than the development side of the R&D process.
"There are issues to be addressed around manufacturing and the scalability and reproducibility of manufacturing.
"There are questions to be answered such as: Can you pool stem cells? What is the right commercialization strategy? Wow do you become a company and earn back that money that was put in?"
"My message is going to be straight forward. Because of the depths of your pockets and lack of competition at the state and federal level, we have an opportunity to shape the way the field is developed.
"My take home message to you today is the 'D' word - development. My advice to you is to subordinate research to support development. Don't eliminate the research in R&D, but do the research as necessary to support the 'D.'"
Thursday, August 24, 2006
Here are his comments verbatim:
"On Tuesday, August 22, you wrote: 'Putting the public universities aside, we suspect that nearly all California agencies require public disclosure of financial interests as opposed to 'secret' disclosure, which is what CIRM does with its reviewers. We base on that on several decades of experience watching California public agencies, but we could be wrong.'Carlson raises a number of interesting issues, but he does not convince us that CIRM's disclosure rules for grant reviewers "go beyond the rules of other state agencies." Much more can and will be said concerning CIRM and disclosure, but CIRM and the California Stem Cell Report differ fundamentally on one central issue. We consider the grant reviewers de facto decision makers. Yes, legally they are advisors and make only "recommendations." But given the nature of such governmental agencies as CIRM, it is unlikely that reviewer recommendations will be overturned by the Oversight Committee in any significant number of cases. If only because the Oversight Committee will soon have no reviewers if it consistently rejects their recommendations.
"You are wrong. California public officials are indeed required to disclose their financial interests – only their financial interests – and to make those disclosures public, as specified by the Political Reform Act (PRA). CIRM staff and members of the ICOC are subject to and complying with those requirements.
"Members of CIRM’s working groups are not public officials. They are advisors, not decision-makers. The distinction is clear and well-defined by the PRA, by the Fair Political Practices Commission and by the courts. Like members of advisory bodies and committees at other state agencies, they are therefore not subject to the requirements of the Political Reform Act. Indeed, as a matter of law, advisors to state agencies – including CIRM – are not required to disclose any information about their personal, professional, or financial interests, to the agency or to the public.
"CIRM working group members are, however, subject to disclosure requirements adopted by the ICOC, pursuant to the mandate of Proposition 71.
"The ICOC requires CIRM advisors to disclose financial interests as well as personal and professional ties to grant applicants. We have a more complete picture of the potential conflicts of interests facing our advisors than the public has of any California official subject to the PRA.
"Our advisors’ disclosure statements are available to state auditors. If we find violations of our policies, the discovery will be reported to the legislature, along with corrective actions to ensure they are not repeated.
"Our conflict of interest policies, including our disclosure requirements for advisors, go beyond the requirements of the law, and beyond the practices of other state agencies, including the universities. If there are stronger policies in force, they’ve yet to be identified.
"The success of the CIRM research program and its ability to maintain the confidence of the people of California depends critically upon the agency’s ability to fund the highest quality research proposals, chosen without bias. We want to attract the best people we can find to help evaluate research proposals, and to ensure that the ICOC has sufficient information to make the best decisions possible.
"Our conflict of interest policies strike an appropriate balance, between the public’s confidence in the integrity of our decision-making and the public value of having the country’s best experts involved in the review of grant proposals."
We do believe that CIRM's disclosure rules go beyond the usual requirements elsewhere in the nation, as do a number of its other policies. Indeed, CIRM has become a benchmark for other states as well as other nations on stem cell policies.
On the day Advanced Cell Technology of Alameda, Ca., announced its new method of extracting stem cells from embryos, its stock more than quadrupled. Of course, it did not have far to go. The stock climbed from 42 cents to 1.83. Today the stock closed at $1.60.
The Wall Street Journal reported this afternoon that the ACT news also "pushed up shares of the four largest publicly-traded stem-cell researchers. StemCells advanced six cents, or 2.7%, to 2.31; Aastrom Biosciences added one cent to 1.20; Geron rose 31 cents, or 4.9%, to 6.67; and ViaCell jumped 19 cents, or 5%, to 4."
The 52-week low for ACT's stock price is 26 cents and its 52-week high is $2.95.
Earlier today, reporter David Hamilton wrote in the WSJ:
"Larger pharmaceutical and biotechnology companies have mostly steered clear of the field, in part because of the ethical controversy and the lack of federal research support. Advanced Cell Chief Executive William Caldwell, however, said he believes an embryo-safe method of deriving stem cells may help spark large-company interest in the area.At mid-afternoon Thursday, the story on ACT in the WSJ did not make the paper's top 10 lists in either the most viewed or most e-mailed categories. But among Web readers of the New York Times, the story was the No. 5 most blogged and No. 6 most e-mailed. At the Los Angeles Times, it was the No. 8 most e-mailed stories but not in the top 10 of most viewed. At the Washington Post, it was the No. 12 most e-mailed story.
"'I think this is going to help address the problem and the issues they have' with stem-cell derivation, Mr. Caldwell said. Advanced Cell, which is currently raising new funds in a private offering to bolster its meager cash reserves, hopes to sign a development partnership with a larger company by the end of the year."
Wednesday, August 23, 2006
The California stem cell agency has posted detailed information on how to snag a chunk of more than $100 million for research involving embryonic stem cells. The deadlines are coming up quickly.
For those of you who do not work in the Golden State, you are mostly out of luck unless you can finesse the rules that limit the grants to academic and non-profit research institutions in California.
While this round does not include grants to businesses, it would behoove them to examine the current process, which is likely to set a pattern for future grants. CIRM said grants for businesses will not be awarded until intellectual property policies are developed (a hearing on that is scheduled for next Tuesday).
The agency is looking for innovation. One two-year, 30-grant program is called SEED, short for Scientific Excellence through Exploration and Development, and is funded at $24 million. The other program contains more cash -- $80 million over four years –for "comprehensive research grants." That 25-grant program will support "mature, ongoing studies" by scientists with a "record of accomplishment."
The deadline for letters of intent to apply for both programs is Sept. 15 with applications due Oct. 13 for SEED and Nov. 13 for the other grants. In addition to the usual scientific information, applicants are asked to provide a "public abstract" intended to explain the research to the lay public. A statement concerning how the research will benefit California is also required. The letters of intent for both SEED and comprehensive grants ask about sources of stem cells and the names of researchers, collaborators and subcontractors.
The application for comprehensive grants seeks "strong preliminary data." "Particular emphasis will be placed on impact and significance and quality of the research plan," the application says.
The lucky winners are expected to be determined at the CIRM Oversight Committee meetings either in February (SEED) or April (comprehensive grants).
Here are links on the grant program: CIRM press release, SEED letter of intent, SEED application information, comprehensive letter of intent, comprehensive application, discussion of the grant program by the Oversight Committee earlier this month (starts on page 149 of the transcript).
Tuesday, August 22, 2006
Writer Andrew Holtz reported on the hooha out here in California – although hooha is probably too strong a word, given that the issue is nearly totally ignored by the mainstream media.
Holtz quoted Zach Hall, president of CIRM, as saying its disclosure rules for grant reviewers "go beyond the rules of other state agencies in California and in fact they go beyond the national standards." While we don't like to quibble with the good doctor, we are not sure he is really on target concerning California disclosure rules. Putting the public universities aside, we suspect that nearly all California agencies require public disclosure of financial interests as opposed to "secret" disclosure, which is what CIRM does with its reviewers. We base on that on several decades of experience watching California public agencies, but we could be wrong.
In the case of CIRM, it requires grant reviewers to disclose basically only to the agency itself.
The article quoted John M. Simpson of the Foundation for Taxpayer and Consumer Rights as calling for more disclosure because of the multimillion dollar impact of actions by the reviewers.
Holtz also interviewed some of the reviewers concerning their sentiments on public disclosure of their financial information.
"One reviewer, Rainer Storb, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, told The Scientist he isn't bothered by the idea of public disclosure of his financial statements. 'The burden is that you have to fill out these forms all the time. That's a bit of a nuisance. But I'm perfectly fine with things being made public,' Storb said.For more on this subject, see "immune feelings" and "second tier."
"Other members of the Grants Review Working Group were either unavailable or said they didn't know enough about the debate to comment. Arlene Chiu,director of scientific activities at CIRM, said many reviewers she had spoken with oppose public disclosure.
"The Director of the Oregon Stem Cell Center, Markus Grompe, who said he was contacted about becoming a reviewer, said his financial ties are already public. 'If they bar you from being involved with biotech to be a reviewer, then that will scare off a majority actually; but if it's just about disclosing it, we disclose all the time,' Grompe said.
"Lisa A. Bero, from the Institute for Health Policy Studies at University of California San Francisco, who has studied conflict of interest issues in medical research, said people have difficulty judging their conflicts of interest. She said the specific CIRM disclosure rules improve upon policies that ask general questions about 'relevant' financial ties, but public
disclosure would still help detect cases where disclosure is less than complete."
The Foundation for Taxpayer and Consumer Rights said today that it is "concerned that the pressure to show results from a program that was approved by voters in 2004 and stalled by legal challenges could lead to hastily made and poorly considered grants that waste public money."
The news release continued:
"FTCR also said that the stem cell institute must have policies in place that ensure any treatments and cures developed with taxpayer money are accessible and affordable for all Californians."The trigger for the foundation's comments is posting of the timelines for application for the research grants. The foundation said that "the letters of intent to apply for CIRM SEED Grants and CIRM Comprehensive Grants will be due Sept. 15. Full applications are due Oct. 13 and Nov. 13 respectively. CIRM envisions awarding the SEED grants in March 2007. The Comprehensive Grants would be awarded in March or April."
Here is a link to the foundation's full statement.
No details have been posted yet for the session, which will also consider comments from the Oversight Committee on IP for non-profits.
The actual meeting will take place at the San Francisco International Airport, but remote sites are available at UC Irvine, Los Angeles and Stanford. Here is a link to the full agenda.
The California stem cell agency skated past the latest attempt to bring more stringent oversight to its unique, $6 billion effort to turn stem cells into cures. That means that critics of the agency are not likely to be successful at bringing CIRM under more state direction for the foreseeable future.
A hefty scandal is about all that would create a climate conducive to major changes at the agency. At the same time, the door has opened for a state politician or two to seize the stem cell issue.
The quiet demise of the stem cell oversight bill by state Sen. Deborah Ortiz, D-Sacramento, signalled the new arrangements. Ortiz is chair of the Senate Health Committee and a pioneer on California stem cell issues. But term limits are forcing her from office at the end of the year and have reduced her legislative clout.
Assemblywoman Judy Chu, D-Monterey Park, chair of the Assembly Appropriations Committee, Thursday dispatched Ortiz' measure (SB401) to legislative oblivion. No vote was taken as Chu ordered the bill held in committee. Chu indicated, among other reasons, that she did not want to move forward with another stem cell ballot measure, which Ortiz' bill would have been.
Ortiz had a different view. She said the bill would have improved the performance of the agency and ensured access to affordable cures.
"The measure was extensively debated and refined during two years of public informational and legislative committee hearings. It had bipartisan support in both houses of the Legislature, and was supported by public interest groups.Normally state departments, of which CIRM is one, are subject to regulation by the state legislature, which approves their budgets and can change their scope or eliminate them entirely. CIRM is radically different. It is a creature of the ballot. Voters altered the state constitution and state law to create the agency. Changes in the agency can only be made by another ballot initiative or by approval of 70 percent both houses of the state legislature and the governor. And that legislative action can only happen three full years after adoption of Prop. 71, which would be in November 2007. The extraordinary, "super-super" vote requirement makes it virtually impossible to tinker with CIRM. It would only 13 state senators to block any changes affecting the agency.
"The bill was steadfastly opposed by the CIRM and the ICOC, the two entities the bill would have opened to increased public scrutiny. This is nothing but an example of a special interest group killing legislation to avoid being held accountable to those it serves."
Nonetheless, political hay can be made involving embryonic stem cell research – on all sides of the issue. Gov. Schwarzenegger, who is facing a re-election challenge, made that clear a few weeks ago when he ponied up $150 million to ease the financial strains at CIRM. The impending departure of Ortiz leaves a void in the legislature on stem cell issues. Just who may fill it is unclear. Assemblyman Dave Jones, D-Sacramento, has been mentioned as one possibility. Ortiz was a friendly critic of the agency, although some at the agency did not regard her in that fashion. An unfriendly legislative critic can create considerable mischief, even if he or she cannot effectively make changes legislatively.
If the concept of political hay mixing with stem cell research is troubling, consider the host of continuing public policy issues involving CIRM and the nature of the research, ranging from treatment of egg donors to conflicts of interest. The fact is that politics and stem cell research are inextricably linked. It behooves the agency to keep a close eye on the state Capitol.
California newspapers paid scant attention to the demise of Ortiz bill. Most, if they carried any article at all, relied on a brief from The Associated Press. Reporter Judy Lin of The Sacramento Bee had a somewhat longer piece.
Wednesday, August 16, 2006
From Loreto, we will leap into a 1986 VW Vanagon and forge north into the deadly heat of the Vizcaino Plain, average annual rainfall less than two inches a year. With luck, we will arrive in the Old Country (the U.S.) in a few days and resume postings as we re-enter the dirt life(life on land) for a short while.
Dale Carlson officially begins work next Monday. As communications director, his responsibilities will include developing a "clear and consistent message about the new frontier of stem cell research in California" and promoting "a deeper and more sophisticated public awareness of stem cell research and therapy." His duties go beyond dealing with the ink-stained wretches of the fourth estate and include developing communications programs with the public, the patient advocacy community, the legislature and the scientific community.
Carlson was vice president for corporate affairs with the Pacific (stock) Exchange in San Francisco from 1987 to 2005. He dealt with the media, business, public and handled a wide range of responsibilities, including dealing with Web content. Carlson also served in a variety of volunteer positions with civic and nonprofit agencies in the Bay Area, including tours of duty as chair of the San Francisco library foundation and the Treasure Island Development Authority.
Carlson, who has a masters degree in health services administration from the University of Michigan, surfaced in February of this year as an "interim senior communications officer" at CIRM, working on a parttime, volunteer basis.
CIRM has had difficulties since its inception with its communications/PR programs, resorting to hiring Edelman PR for $378,000 for a 16-month contract that expires at the end of this month. One problem was the lack of a senior CIRM official with specific PR responsibilities, which Carlson's appointment seems to solve.
In the interests of full transparency, we must disclose that Carlson is a sailor, as are we. He describes himself as a "competitive" sailor. We are just your average sea dog.
The salary range for Carlson's position is from $130,000 to $195,000. We expect to have the specific figure soon.
Details of the outline are not yet available and may not be available by the time of the meeting, given the way the agency works. Nonetheless the San Francisco meeting is open to the public. See the agenda here but don't expect illumination.
The article wrapped up the private giving and help that has come CIRM's way. It also quoted the critics on the propriety of CIRM's ties to private benefactors.
However, Hamilton did not cite an earlier WSJ piece about how even small financial favors can create a feeling of indebtedness that is not fully comprehended by the recipients of the largesse.
Most of the details of Hamilton's piece are familiar to our readers. But we should note that because of the prestige and wide national readership of the WSJ, his article is likely to have more impact than if it had appeared in a smaller, regional paper. Play prominence -- meaning the front page display -- also counts.
Hamilton's piece additionally looked at the impact of private funding outside of CIRM. He wrote:
"USC has a new building that could become the state's largest stem-cell research center on the drawing board. It also recently hired Martin Pera, a prominent researcher from Australia, to run its new stem-cell research program. That step is notable in part because the federal restrictions sparked fears that U.S. scientists would leave the country to pursue their work.
"UCSF is using private money to renovate an entire floor of a building so that its stem-cell researchers will be able to work in a central location. One team deriving new stem-cell lines currently works in a laboratory at Menlo Park, Calif.-based biotechnology company Geron Corp., while another labors at an off-site leased facility in San Francisco.
"The university also is proposing an entirely new research building at the cost of as much as $100 million. Much of that must be raised privately, although Arnold Kriegstein, director of the university's stem-cell program, hopes CIRM might also be able to kick in some funding. 'Fund-raising is one of the bottlenecks to getting moving as quickly as possible,' says Dr. Kriegstein."
Tuesday, August 15, 2006
The agency has nearly completed its interviews for the planning process. As of late last month, 59 persons were interviewed with a target of perhaps 70. The list ranges from Bruce Alberts, former president of the National Academy of Sciences, to Leonard Zon of the Harvard Medical School. Also included were a number of the agency's staunch critics.
Last month, the agency held a conference on "Industry and Stem Sells in California: Fostering Research and Development." The presenters came from a blue ribbon array of stem cell-connected companies ranging from Geron to Burrill. Here are links to their Power Point presentations.
Sumit K. Chanda, Ph.D., Group Leader, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation
Bruce Cohen, President and CEO, Cellerant Therapeutics
Ann F. Hanham, Ph.D., Managing Director, Burrill & Company
Martin McGlynn, President and CEO, StemCells, Inc.
Thomas B. Okarma, Ph.D., M.D., President and CEO, Geron Corporation
Alan K. Smith, Ph.D., President and Chief Operating Officer, Cognate BioServices
Michael D. West, Ph.D., Chairman of the Board, President and Chief Scientific Officer , Advanced Cell Technology, Inc
E. Edward Baetge, Ph.D., Chief Scientific Officer, Novocell, Inc.
Another conference last month dealt with “The Scientific Challenge: From Basic Research to the Clinic.” The speakers and their Power Point presentations:
Stuart Orkin, M.D., Harvard Medical School, Chair, CIRM Scientific and Medical Research Funding Working Group, “Stem Cells: Looking Back and Ahead”
Jill Heemskerk, Ph.D., National Institute of Neurological Disorders and Stroke, “The SMA Project: A New Approach to Therapy Development at NIH”
Allen M. Spiegel, M.D., Albert Einstein College of Medicine, “Delivering on the Promise of Stem Cell Research: What Will it Take?”
Stephen A. Sherwin, M.D., Cell Genesys, Inc., “The Development of Novel Cellular Therapeutics: Some Lessons from the Private Sector”
Monday, August 14, 2006
In Monday's edition, reporter Nicholas Wade discussed the split between those who want to see development of stem cell therapies versus those who see embryonic stem cells as a research tool to study mechanisms of disease.
That discussion has rumbled through CIRM for most of its existence, with patient advocates making impassioned pleas for quick results, declaring the longer it takes the more people die – an argument Wade does not explore. Since patient advocates hold 10 seats on the 29-member CIRM panel that ultimately decides who gets the cash, their views are not to be sniffed at. The issue is also near the center of the strategic planning process, which is scheduled to end in December. (See "clashing interests" for a look at the splinter within CIRM.)
"Many (scientists) no longer see cell therapy as the first goal of the research, parting company with those whose near-term expectations for cell therapy remain high.Wade said there is a "gap between scientists’ views and those of the public and of people for whom the overriding purpose of research with human embryonic stem cells is to generate cells that can restore damaged tissues."
"Instead, these researchers envisage a longer-term program in which human embryonic cells would be a research tool to study the mechanisms of disease. From this, they say, many therapeutic benefits may emerge, like new drugs, which would probably be available at least as soon as any cell therapy treatment."
"Thomas M. Jessell, a neurobiologist at Columbia University Medical Center in New York, said that he hoped to see the research generate new drugs for neurodegenerative diseases within the next five years but that it could be a long time before rational cell-based therapies are effective.Wade said:
"'Many of us feel that for the next few years the most rational way forward is not to try to push cell therapies,' Dr. Jessell said. Scientists have spent the last five years mostly in learning how to grow human embryonic stem cells in the laboratory and how to make them differentiate, meaning to turn into the body’s various types of mature cells.'"
"Researchers have not, however, abandoned cell therapy, in which cells themselves would be used to regenerate tissue. In Parkinson’s disease, for example, dopamine-producing cells from aborted fetuses, when injected into the brains of Parkinson’s patients, do have an effect, suggesting that a better source of cell could have therapeutic value. 'So it’s the perfect place to go in,' said Dr. Asa Abeliovich of Columbia University Medical Center. Dr. Abeliovich said that with Alzheimer’s disease, in contrast, 'We don’t know how or what to replace.'"While scientists have preferences on the direction of stem cell research, no research is done without funding. Given the amount of money that CIRM can bring to bear on the subject (10 times the annual spending of the NIH on ESC research), the views of scientists oriented towards use of ESCs as research tools may not be the key factor in determining the main direction of new stem cell research in the United States.
Bruce Alberts, professor of biochemistry at UC San Francisco as well as president of the NAS from 1993 to 2005, said that scientists who make de facto decisions on requests for millions of dollars should not be required to disclose their financial holdings.
Writing in the San Jose Mercury News, he said CIRM has taken "strong measures" to avoid conflicts of interest. Alberts declared:
"Scientists view serving on (grant) review committees as a public service, and many of the best will decline to participate in institute reviews if their private financial information is to be made available for everyone in the world to see. California then runs the risk of wasting critical resources by not making the very best decisions on how to make these important investments for the public good."Alberts does not address the issue of whether there is a significant conflict of interest problem involving medical researchers generally. But we all know of the continuing string of stories about researchers whose ethics are suspect. More recently, the Wall Street Journal wrote about just how favoritism creeps in and how researchers seem "immune" to feelings of conflicts of interest. The Journal said,
"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."We acknowledge that some scientists may beg off service on the CIRM grant review committees simply for privacy or philosophical reasons. But does that mean only the second tier will serve? Perhaps that is a question to be asked of the 29 persons who oversee the $3 billion California stem cell agency, all of whom must publicly disclose their financial information. One of those persons is the vice chancellor for medical affairs at UC San Francisco. He is also Alberts' boss.
Sunday, August 13, 2006
Their sentiments were voiced at a focus group called by CIRM last month as part of its strategic planning process. Their mostly anonymous comments can be read in a 17-page summary available on the CIRM web site.
The questions posed to the focus group ranged from how does CIRM measure success 10 years out to balancing high-risk research with the go-safe-but-slow approach.
In terms of 10-year goals, one sentiment jumped out, at least to us. That was the need for more collaboration, sharing and transparency. A variation of that feeling also surfaced during a segment involving public education.
Sometimes one is given the impression that collaboration and sharing go without saying in today's world of instantaneous communications. But apparently not, in the view of a number of patient advocates.
Some of the proposed 10-year measurements of success were more specific, such as this one:
"Success would be that stem cells or their derivatives would have cured many of the diseases that plague society."Another patient advocate suggested a 10-year goal of one approved therapeutic intervention and three advanced clinical trials.
On the subject of risk, participants endorsed using portions of CIRM's $3 billion for riskier projects, although the proposed percentage varied.
CIRM President Zach Hall commented:
"At the time of the Human Genome Project, there were two proposed approaches to sequencing the genome. Someone who advocated the approach that ultimately wasn't chosen left the NIH to set up a competing project. That was Craig Ventner. The competitive pressure he exerted caused the NIH to change its strategy and accomplish things much faster. Some say they wouldn't have done that without competition from Craig Ventner. It's true the NIH study sections put a big priority on feasibility and likelihood of return. I don't know that we look to you for an answer but we do listen for whether it's more important to have tangible progress or are we willing to risk some of the money on a gamble that may fail."Hall also indicated that a focus group will also address the question of public education.
On Sept. 28, at the request of CIRM, the Institute of Medicine and the National Research Council will hold a conference near the San Francisco airport on the medical risks of egg donation. This is the conference that CIRM has talked about for months. A high-powered group from throughout the country is scheduled to speak.
On Sept. 28-29, "Ethical Worlds of Stem Cell Medicine" is the topic at UC Berkeley. "Academic Industry Alliances" and "Procurement and the Integrity of the Human Subject" are among the topics. The conference overview notes that today's stem cell medical environment has generated a "surfeit of promissory biocapital." The session is sponsored by the Science, Technology and Society Center at UC Berkeley.
On Oct. 14, "Toward Fair Cures: Integrating the Benefits of Diversity in California's Stem Cell Research Program" will be held at the Children's Hospital in Oakland. The conference is sponsored by the hospital, the Greenlining Coalition and the UC Berkeley Project on Stem Cells. CIRM President Zach Hall is scheduled to appear along with Evelynn Hammonds of Harvard. We do not have a Web site for this yet, but you can contact Joe Tayag of Greenlining at firstname.lastname@example.org.
Friday, August 11, 2006
The East Coast effort is modest and not exactly ballyhooed. But nonetheless it is on the home page of its stem cell program. Right there with a big dollar sign, it commands: "Make a Donation."
Given the perceived widespread support for stem cell research in the Golden State, it would seem appropriate to make it easy for anybody to make a donation whenever the whim struck. Connecticut can only take checks and is looking into credit cards, but that is hardly an obstacle.
In California, it should be able to be done with a minimum of effort without waiting for the redesign of the CIRM website. At least one state agency, the Department of Motor Vehicles, already takes credit cards, so little would seem to be in the way.
Let the money roll in!
As in California, money is an issue. Some in Connecticut seem particularly impressed with CIRM's prodigious fundraising efforts in the private sector. Connecticut's stem cell research advisory committee wanted to know more about it, according to the transcript from a July 18 meeting. All the persons mentioned below are members of that committee, including Ann Keissling, who serves on a CIRM working group.
Myron Genel, professor emeritus Yale School of Medicine:
"I think that Bob, you’re right, that it’s difficult to raise those funds, but I think that Ann earlier and that you Charles were indicating that it’s happening someplace. It’s happening in California. So that -- and I think it was Bob, you talked about you need to have the right strategy. To me a first step would be to confer with California. See what’s making -- allowing them to be successful."Ann Kiessling, member of the CIRM Standards Working Group and faculty member at Harvard Medical School:
"One of the most straight forward things that they did I think as their overall working group is they sort of looked at the income of people in California and asked most of those people to sit on one of their boards. So they went to the very top income producing people."
Commissioner Robert Galvin, Connecticut state commissioner of public health:
"The wealthiest individuals in California and they asked them if they would like to, you know, sit on one of the committees. So a lot of those -- "Galvin:
"And to contribute?"Kiessling:
" -- well, not necessarily contribute, but you know, that’s a group of people that talk to each other and for instance the co-chair of the Standards WorkingGalvin:
Group in California, which is a group similar to this, it’s an advisory group as to how you’re supposed to go about what kind of ethical issues and how the money should be disbursed. The co-chair of that is Sherry Lansing (phonetic), who was CEO of Paramount Pictures for many years. You know, Sherry knows probably almost everybody in California. And the other person who was a very prominent member of that committee was Bob (Klein), who is the one who almost single handedly got the tax, you know, bond measure passed in California. So they really involved the people who could actually contact a lot of people in their committee work."
"That’s a very good point Ann because you’ve got to get to the decision makers."Given the nature of Keissling's comments, we asked her if she had more to say. Here is her response verbatim:
"One of the most noteworthy aspects of the CIRM committees is enthusiasm and dedication to the task at hand. It has been a monumental task, moved forward with incredible determination and regard for public opinion.The exchange involving the committee begins on p. 85 of the transcript.
"I think it is a good example of how opening the doors to the public generally has more positive than negative impact on new biomedical technologies, in contrast to the views of some that public involvement may impeed progress.
"My comments about who to involve on committees was meant to reference fund-raising ability -- individuals who both know who might be able to contribute and also have the enthusiasm and dedication to seek the funds. I did NOT mean to imply that especially wealthy individuals were specifically selected for committee assignments, as the quote below seems to suggest, that is not my impression.
"But having one third of the committees be 'lay persons' advocating for a specific disease provided a sense of urgency and dedication that truly supported the enthusiasm of scientists for getting the work done as quickly as doing a good job would allow. One disease advocate that comes to mind is Jonathan Shestack, a movie producer-advocate for autism ('Cure Autism Now') -- a member of the Standards Working Group -- thoughtful, erudite, energetic and driven -- a huge asset to getting the work done timely and as perfectly as possible.
"I've always been a supporter of public involvement in high tech issues, and my California committee experience has strengthened this view."
Thursday, August 10, 2006
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
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 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?"
"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."
Monday, August 07, 2006
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."