WARF Patent Challenge Coverage: More Likely to Come

The California-based effort to overturn restrictive patents on embryonic stem cell research received a dab of national coverage Wednesday amidst the hoopla about the U.S. Senate vote on Bush's policy.

More coverage on the issue could easily develop. ScienceNow, the online arm of Science magazine, promised a deeper look at the subject on Friday.

The California stem cell agency is maintaining an arms-length relationship to the matter. The agency released a statement from Ed Penhoet, vice chairman of CIRM. Here is the full text, which is not currently available on the Web:

"The CIRM is in the business of providing the necessary funding and infrastructure to help others move the stem cell field forward. There are those who say they are speaking on behalf of California, but they
are not speaking for the CIRM. Currently, we have no opinion on the enforceability or scope of WARF's patents."

Aside from the basics that we reported yesterday, here are some snippets from various stories.

Eli Kintisch of ScienceNow noted that "Harvard pancreatic cell researcher Doug Melton calls WARF's licensing terms 'onerous, restrictive, and uncooperative.'"

Reporter Jim Downing of The Sacramento Bee wrote:

"Negotiating patents and licenses is an everyday part of biotech research and development. But, said Wendy Streitz, policy director for the University of California's office of technology transfer, the way that Wisconsin is choosing to exercise its patent rights is unusual.

"'It's not the cost of the license that's the issue. It's the very fact that we're being asked to take one' -- a requirement that breaks with academic tradition, she said. 'There is the concern that if this became common practice, university technology transfer offices would be spending all of their time issuing licenses to each other.'"

A lengthy story by Sandy Kleffman of the Contra Costa Times appeared in the Kansas City paper, where it has special relevance because of the stem cell ballot measure there.

In Wisconsin, reporter John Fauber of the Milwuakee Journal Sentinel wrote:

"WARF officials declined to be interviewed about the challenge. In a prepared statement, Carl Gulbrandsen, managing director of WARF, said he was confident that its patents were valid. He said the challenge was politically and financially motivated.

"'WARF stem cell patents do not inhibit research,' he said. 'They support and encourage it.'"

The story continued:

"Daniel Ravicher, executive director of the Public Patent Foundation, said the WARF patents have not been challenged before. He said the patent office should decide within three months whether a challenge to the patents is warranted. After that, a decision on the challenge could take 18 months to 10 years."

The issue was also touched on briefly in a piece in the New York Times by Andrew Pollack.

Here are links to the stories by Steve Johnson, San Jose Mercury News, and Lee Romney, Los Angeles Times.

Veto to Hinder California Stem Cell Research

What does the president's veto of the stem cell bill mean for California? Reporter Paul Jacobs of the San Jose Mercury News took a crack at the answer, writing that efforts in the Golden State would be "hindered."

Here is the salient language in his piece:

"...(T)here are ramifications for state-funded research in California -- both direct and indirect.

"The state will still be able to go ahead with plans to spend funds from a state bond measure authorized by Proposition 71 two years ago, but researchers worry that they will continue to waste valuable resources because funding restrictions will force them to create facilities to do work that might have been shared by existing labs.

"Robert Klein, chairman of the committee that is overseeing spending of the state funding, describes Bush's decision as 'tragic.'

"'We could get greater leverage out of our $3 billion if we were able to use federally funded facilities currently in place,' said Klein, who led the effort to pass a stem-cell funding initiative in 2004.

"Said Stanford Nobel laureate Paul Berg, a critic of the administration: 'What many people don't understand is it is not just the money.'' Equipment and laboratory space supported with federal dollars cannot be used for research with the newer stem-cell lines, he said. That's why money directed toward research from California and other states 'is not the whole answer.'

"Dr. Irving Weissman, a stem-cell researcher and director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine, agrees that the federal restrictions have impeded stem-cell work. He noted, for example, that analyzing the genes from new stem-cell lines cannot be done at federally funded facilities on the university campus.

"Another effect is more indirect. Science advances when researchers worldwide are able to pool their data and findings, but researchers in California using state funds who might have collaborated with scientists elsewhere doing federally funded research will not have that luxury.

"Klein said about 50 percent of the nation's biomedical research capacity is in California, and if the other half of the country is hindered, it has an effect everywhere."

Here is Klein's full statement.

The President’s failure today to sign HR 810 is tragic for stem cell science in America and for patients and their families. As a father of a child with juvenile diabetes and the son of a mother suffering from Alzheimer's, I am personally extremely disappointed by the President’s decision to issue his first veto. I am disappointed for every family in California and around the nation with a child, a parent, or any family member suffering from chronic disease and injury. The President’s decision represents a missed opportunity for the U.S. to serve the will of the people and regain leadership in this promising field.

"In order to serve patients, we still need to work together at the state and national levels to move stem cell science forward. In California, stem cell research enjoys broad support of the people and their leaders. Governor Arnold Schwarzenegger personally wrote the President a strong advocacy urging him to sign the bill. In addition, legislative leaders like Speaker Nunez and President Pro Temp Perata, as well as constitutional officers like Lt. Gov. Bustamante, Treasurer Angelides, Controller Westly, Attorney General Lockyer and others are united in support of stem cell research. We are grateful for this broad support

"We all know that the road to stable and adequate funding of this most promising area of science has proved more difficult than we could ever have imagined. Although time is precious, we look forward to the next opportunity to debate—and pass—meaningful stem cell policy at the federal level. But in the interim California moves forward with funding this science. California will continue to lead the nation."

R&D Stem Cell Session in San Francisco Tuesday

Coming up next Tuesday is a promising session with the California stem cell agency on the topic of fostering research and development in California.

It is another chapter in CIRM's effort to come up with a plan to give away $3 billion.

While the subject of WARF and its patents is not specifically listed on the agenda, it seems likely to come up, particularly in the wake of this week's formal challenges of the patents.

The afternoon session in San Francisco includes the following speakers:

E. Edward Baetge, chief scientific officer, Novocell, Inc.; Sumit K. Chanda, group leader, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation; Bruce Cohen, president and chief executive officer, Cellerant Therapeutics; Ann F. Hanham, managing director, Burrill & Company; Martin McGlynn, president and chief executive officer, StemCells, Inc.; Thomas B. Okarma, president and chief executive officer, Geron Corporation; Alan K. Smith, president and chief operating officer, Cognate BioServices, and Michael D. West, chairman of the board, president and chief scientific officer Advanced Cell Technology, Inc.
 

Industry-supported Changes in IP Rules Face August Action

The California stem cell industry has scored a preliminary victory in modifying state rules that it said would hamper private investment in embryonic stem cell research.

The Intellectual Property Task Force for CIRM last week approved the modifications in previously ratified regulations. The recommendation now goes to the CIRM Oversight Committee Aug. 2, where it is likely to receive positive action, although not without continued opposition from watchdog groups.

During consideration earlier this year of IP rules for nonprofit institutions, Oversight Committee members had indicated support for the widest possible dissemination of basic research.

Sandy Kleffman of the Contra Costa Times reported:

"To accomplish that goal, (CIRM) adopted a preliminary policy requiring that companies provide university scientists and others engaged in noncommercial research with access to state-funded inventions and research tools free of charge.

"The goal was to avoid having stem cell researchers subjected to lawsuits from companies complaining they were infringing on a patent.

"But a host of biotech leaders wrote to complain about this policy, arguing that it would cause venture capital firms to balk at getting involved.

"'Under those circumstances, we believe no private funding will be used to license the invention and none of the energy of the commercial market will be made available to enhance, manufacture, advertise, disseminate or support it,' wrote Greg Lucier, chairman and CEO of Invitrogen Corp.

"Task force Chairman Ed Penhoet said he agreed to eliminate the provision, even though he supports it, because many researchers and companies already share such discoveries with others. But the stem cell agency will revisit the issue if a problem develops, he added."

Jim Downing of The Sacramento Bee reported that biotech firms argued that the old rule

"would deprive them of revenue from their primary customers -- other California stem-cell researchers -- and remove the incentive for investment. Joydeep Goswami, vice president of Carlsbad-based Invitrogen Corp., said the rules of the market would keep innovations developed by the private sector at a fair price.

"'It's not in our interest to not make tools available,' he said."

Downing also quoted John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights.

"I'm disappointed that they haven't been able to understand the importance of maintaining a payback to all the Californians who are coming up with this money."

Simpson is likely renew his pitch at the Aug. 2 meeting, perhaps with the support of other organizations.

WARF Patents Under Renewed Assault

As the U.S. Senate wrestled today with embryonic stem cell research, a closely related brouhaha escalated sharply over who owns the rights to "nearly any use" of embryonic stem cells.

Until today, the "rights" debate seemed little more than dueling op-ed pieces. But the Foundation for Taxpayer and Consumer Rights in Santa Monica, Ca., and public service patent attorneys filed challenges to the stem cell patents held by WARF – the Wisconsin Alumni Research Organization.

The move was an extension of the foundation's activities related to the California stem cell agency. John M. Simpson, the foundation's stem cell project director, has been campaigning for months against WARF's position that California should pony up for research involving the patents.

The stem cell agency itself -- CIRM -- has held hearings during which experts have testified to the deleterious impact of the WARF patents on stem cell research.

This morning the discussion moved to the Wall Street Journal. A piece (available at no charge here) by writers Antonio Regalado and David P. Hamilton said,

"...(T)he strict limits imposed by the Bush administration are only part of what's hindering stem-cell research. Another problem: several broad patents held by a University of Wisconsin foundation.

"When executives at Carlsbad, Calif.-based Invitrogen Corp. chose to locate their stem-cell research in Asia recently, they blamed the patents. And today, a California watchdog group, the Foundation for Taxpayer and Consumer Rights of Santa Monica, says it will ask the U.S. Patent and Trademark Office to overturn three patents awarded to James A. Thomson, the Wisconsin researcher who first isolated stem cells from human embryos in 1998."

The writers said the patents "cover nearly any use of human embryonic stem cells."

The WSJ reported this response from WARF:

"WARF officials say they are simply enforcing their legal rights by charging companies to license the patents. 'It's a red herring. People want free access,' says Elizabeth Donley, executive director of the WiCell Research Institute, a center created by WARF in Madison to study and distribute the cells. Ms. Donley says the fees are invested back into research being performed at the university."

Simpson's group issued a press release that said:

"The patent challenges filed today call on the United States Patent and Trademark Office to re-examine and revoke three patents that give the rights to all human embryonic stem cells used for research to the Wisconsin Alumni Research Foundation. The groups estimate that the patents could result in hundreds of millions of dollars of research money being sent overseas each year. Already, the Juvenile Diabetes Research Foundation has funded scientists in other countries and calls the WARF patents a “major inhibition to productive scientific research.”

"'It is absolutely absurd that one person or organization could own the rights to life itself. But that is exactly what has happened because of these over-reaching patents,' said John Simpson, Stem Cell Project Director for FTCR. 'The real debate in stem cell research is not about the science, but whether American scientists will be allowed to participate in the global laboratory.'"

The press release continued:

"'WARF has been allowed to profit at the expense of public health while many American scientists have been barred from conducting life-saving medical research. These over-reaching patents threaten our health, waste taxpayer money, and send valuable research overseas," said Dan Ravicher, Executive Director of (the Public Patent Foundation). 'We’re calling on the United States Patent Office to revoke these overreaching patents.'

"The groups said the patents' dubious validity is underscored by the fact that no other country in the world honors them. As a result, U.S. researchers have sent research monies abroad where they can avoid paying royalties to WARF."

Also participating in the patent challenge was Jeanne Loring of the Burnham Institute, who has long argued against WARF's position.

She said,

"'These patents should have never been issued in the first place. The real invention was made 25 years ago, when embryonic stem cells were first discovered – and the scientists who discovered them didn't expect a payoff. James Thomson just followed a recipe written by other scientists, and there's nothing patentable about that."

You can find Loring's declarations on the foundation's web site via the press release along with the official texts of the challenges.

CIRM Spawns 'New Life' -- Partly

The Journal of Neuroscience has published a piece that says U.S. stem cell research has "taken on new life, driven in part by the California experiment."

Written by Arlene Chiu, director of scientific program and review for CIRM, and Zach Hall, president of CIRM, the brief article is a straightforward account of CIRM's short life. Most of the history is quite familiar to readers of this blog.

But the pair did note an often overlooked fact that the agency has approved "the most comprehensive set of regulations on stem cell research in the country." While Chiu and Hall avoided touting the regulations, it is fair to say they are the benchmark for ESC research rules in the United States.

Chiu and Hall also wrote,

"Despite the lack of funding, Prop. 71 has provided an important stimulus for stem cell research in California and other states. In California, universities and other research institutions have hired new faculty, raised private capital and planned new buildings for stem cell research so that they will be read to compete for public funds once they are available. Faced with competition from California, other states have committed funds, and, in some cases, private foundations have been started to support local stem cell research. As new efforts are mounted in various states across the country, it will be important to ensure mechanisms for collaboration and for transparency, so that new stem cell lines that are derived can be widely shared."

Speaking of sharing, the article is not available online except to subscribers of the Neuroscience Journal. But you might be able to get a peek at if you make a request via the agency.

The article was printed in the June 21 edition of the journal, whose cover consisted of an interesting illustration/outline of California as a cluster of globules. The graphic was executed by Gil Sambrano, scientific review officer for CIRM.

WSJ Highlights Research Conflicts of Interest

Talk about prescience. Two days after reporter Paul Jacobs published his piece about the web of financial ties between Stanford medical researchers and the medical business, the Wall Street Journal pops up with a first rate example of the nexus of money and medicine.

In Tuesday's WSJ, reporter David Armstrong discussed a study in the February issue of the Journal of American Medical Association that said stopping antidepressant medication during pregnancy greatly increases the risk of relapsing into depression. Good news, Armstrong said, for makers of antidepressants who are facing questions about the safety of their products.

"But the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants. The lead author -- Lee S. Cohen, a Harvard Medical School professor and director of the perinatal and reproductive psychiatry research program at Massachusetts General Hospital -- is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers. None of his financial ties were reported in the study. In total, the authors failed to disclose more than 60 different financial relationships with drug companies," Armstrong wrote.

The California stem cell agency is resisting legislative efforts to require more disclosure about potential conflicts of interests involving its work. The Wall Street Journal story is another good example of why CIRM needs to open its doors more widely. Sunshine is the best prevention of misdeeds in public life.

Stanford's Rationale for Release of Conflict Info

Stanford University's decision to release information on the relationships between researchers and the corporate world is not one that all in academia would agree with. Nonetheless, it was a healthy response that undoubtedly staved off dribs and drabs of stories that would have reflected poorly on the school.

The San Jose Mercury News piece on the subject (see item below) did not discuss Stanford's reasoning behind the release of the information. We asked Paul Costello, executive director of the Office of Communication and Public Affairs at the Stanford School of Medicine, for comment on the decision to go public. Here is his response verbatim:

"The conflict-of-interest issue is an important topic that merits discussion and debate. Clearly from the highest levels at Stanford -- President Hennessy to Dean Pizzo -- transparency is viewed as essential if we are to help inform the public about the benefits of the biomedical community's involvement with industry.

"Much of the interaction between universities and industry is driven by the 1980 Bayh-Dole Act, which was enacted with the goal of speeding up the commercialization of federally funded university research and helping new industries develop more quickly.

"The Council on Government Relations estimates that there are now more than 1,000 products on the market based on university-licensed discoveries, including many that are used in diagnosing and treating diseases. Yet we also recognize that collaboration between university researchers and private companies carries the potential for conflicts of interest. Stanford has been, and will continue to be, vigilant in monitoring these interactions to ensure that the integrity of our scientists and of their research is not compromised.

"When we were contacted by the Mercury News reporter about the conflict-of-interest topic, we wanted to work with him so that this important story could be told as accurately as possible, and to demonstrate Stanford's considerable efforts to conduct its industry interactions with integrity."

Stanford University: Medical Research, Money and Conflicts of Interest

In a news story that has major implications for the California stem cell agency, the San Jose Mercury News has detailed a web of relationships that have enriched Stanford University and "fattened the personal bank accounts of many of its prestigious faculty members."

The article by reporter Paul Jacobs is a rare look inside the normally private Stanford documents designed to monitor the ties between faculty and medical companies.

The story said:

"Dozens of professors moonlight for medical firms or have founded companies based on their government-funded research.

"In the 2004-05 academic year alone, $38 million in royalties poured into the university from medical school discoveries -- roughly $10 million of which went directly to faculty researchers whose discoveries were patented.

"Critics worry that these complex financial and ethical relationships between companies and the nation's premier research universities are corrupting science and producing overly enthusiastic portraits of new treatments."

Friends and foes of the California stem cell agency have longed expressed reservations concerning the built-in and legal conflicts of interest that riddle CIRM. A measure –opposed by CIRM -- is now before the legislature to tighten oversight and force more disclosure of potential conflicts of interest.

Jacobs' thorough and even-handed story, based on six months of work, said:

"Financial conflicts can turn campus laboratories funded by taxpayer money into outposts of corporate research. They can divert researchers from work that might have a bigger impact on health toward research with bigger financial rewards. And in the worst cases, they can blind scientists to the dangers of treatments they are studying, resulting in injury or even death among volunteers."

The story noted that links between medical research and the corporate world exist at virtually every major unversity in the country.

Stanford voluntarily disclosed to the San Jose newspaper overall figures for a single year concerning its faculty's relationships. The article did not explain the university's reasoning behind the disclosure, but it was a bold decision – one that reflects well on the school but one probably opposed by significant segments within the university. The action was fundamentally good public relations. The choice is to release more information, as the school did, or suffer mightily as bits and pieces dribble out, each one making Stanford look worse and worse.

Philip Pizzo, dean of the medical school and a member of the Oversight Committee for the California stem cell agency, told Jacobs that conflicts are unavoidable but manageable. He said Stanford's "standards for dealing with conflicts are 'the most rigorous' in the country."

But, Jacobs reported, Pizzo "also says ties to industry are necessary if the university is to translate its research into practical treatments for patients."

Not everyone agrees with Pizzo on the "manageability" of conflicts. Jacobs wrote:

"'There is a focus on procedural solutions and this magical belief that disclosure is the answer as opposed to dealing with the fact that many of these things should not be allowed,' said Barbara A. Koenig, a bioethics researcher at the Mayo Clinic and former executive director of Stanford's Center for Biomedical Ethics.

"Tufts University Professor Sheldon Krimsky, author of 'Science in the Private Interest,' argues that fields such as law have stricter conflict policies than universities. A judge, for instance, isn't allowed to have any financial relationship with a party that might benefit from a ruling."

Jacobs' article also included the following segment on one of the brighter stars in stem cell research.

"...(N)o one is more up-front about his financial conflicts than Dr. Irving L. Weissman, one of the founding fathers of stem-cell biology. His lab at Stanford was the first to isolate blood-forming stem cells from animal bone marrow. Today, in addition to his own lab, he directs Stanford's Institute for Cancer/Stem Cell Biology and Medicine.

"Weissman's research has made him a multimillionaire entrepreneur.

"When he gives speeches, when he publishes papers, when he testifies before Congress, he lets everybody know what his outside financial interests are.
"After serving on the scientific advisory boards of Amgen and DNAX, he helped launch three companies, all based on his stem-cell expertise and, in varying degrees, on the research done in his medical school laboratory.

"Weissman recently recalled what led him to form the first of his companies, SyStemix.

"He describes a frustrating year trying to get the facilities he would need on campus to advance his work. He finally concluded in late 1988 that he would have to start a company. He went to (Donald) Kennedy, Stanford's president at the time.

"A biologist who is now editor in chief of Science magazine, Kennedy had reservations. 'I didn't want faculty wandering from their homes on campus into labs thinking about money in their next offshore venture,' he recalled.

"But Weissman convinced him that he could separate his work at the company from his work in the lab. A faculty committee would look at his NIH grants every year to see, Weissman said, 'if I was starting to slant my grants in favor of topics relevant to the company.' He and Kennedy agreed Stanford would not take shares in the company, avoiding a financial conflict for the university -- a policy later abandoned.

"Today, Weissman sits on the boards of directors and scientific advisory boards of two other companies he co-founded -- StemCells Inc. and Cellerant Therapeutics. His method of handling his conflicts, primarily through disclosure, has become the standard at Stanford and other medical schools.

"'The way I usually do it is, I say, `I have stock and I'm a director of this or that, so you might think I'm biased. I don't think I'm biased, but there could be unconscious bias, so you judge,' he said.

"'You ought to be able to do whatever experiment along this line with transparency so everybody knows at every step of the way what your involvements are, what your bias might be, so you can move it forward,' he said, referring to scientific progress. 'But I think it's morally reprehensible not to move it forward.'"

California AG Moving Against CIRM Foes

California Attorney General Bill Lockyer is expected today to attempt to kill off the latest effort to halt work by the California stem cell agency.

The likely action was reported by the California Politics Today web site. Basically the attorney general's reasoning is that the effort to halt funding of grants to the University of California has already been decided in Alameda County Superior Court.

The latest anti-CIRM effort has received virtually no attention in media. Marc Strassman, who runs the California Politics Today site, has been alone on the story, as far as we can tell. His site includes audio interviews with some of the principals.

Stem Cell Research and Bringing Camels into the Tent

"You’re at a point where you can change the world." -- Michael Amos of the Advanced Technology Program at the National Institute of Standards and Technology.

Just one of the comments emerging from the search by the California stem cell agency for a plan on how to give away $3 billion.

Amos' comment was contained in a freshly posted document on the CIRM's Strategic Planning Web site. The 31-page report is a concise summary of the May 25 scientific conference and is filled with provocative and wide-ranging ideas, including reflections on the political impact of research that produces negative results.

A presentation, however, by Jonathan Shestack, a CIRM Oversight Committee member and co-founder of Cure Autism Now, caught our eye. He discussed the importance of sharing and how his organization was surprised by the lack of communication in the autism field. He also discussed the need to become an informational resource that benefits all research in a particular field.

Here are some excerpts from Shestack's comments as summarized by CIRM:

"The most important thing anyone said to us was that we had to 'become the data.' At that point we couldn't rely on people sharing data or raw materials. It was sort of an education to us that people didn't routinely share data."

"We realized we couldn’t rely on making people share so we had to become the central resource and that's what we did, and it's been the best return on investment."

"We were really sort of bootstrapping the field, but we have to guard against becoming institutional and what we hate the most. And that's the biggest danger CIRM has."

"Nothing good ever came to CAN (Shestack's group) without us giving things away. The more CAN gave things away and didn't worry about ownership or getting credit or getting cited, the better it was for us, not as an institution, but to the field. I have this deep feeling that the more you give it away the better it will be."

"What is true and does pertain to CIRM is how to bring many people together. We have complicated problems with different issues and it's a constant struggle to keep people in the tent. We started with the assumption that we would never be able to close the flaps of the tent and say we've everything. We're constantly trying to bring more and more people into the tent."

CIRM President Zach Hall spoke to the issue of what some might call managing expectations.

"Someone today said if you don’t have lot of failures you not being adventurous enough. I have commented on the gap between the political and scientific cultures in California. People have to understand that not all science succeeds. If you are too successful you're not adventurous enough on setting those goals. That's a balance we'll have to strike. It is an education matter in the end. It is also a policy matter and we'll discuss at a later session how to balance innovation and results and how to get the singles and not just the home runs to push things forward."

It is hard to overemphasize Hall's point. The public and advocacy groups want and are conditioned to expect instant solutions and cures. Indeed, American society is oriented in that direction. Without laying the groundwork as soon as possible and educating the public, CIRM could become ensnared in a few years in an unpleasant trap when critics begin to demand: "Show us the beef." At the same time, CIRM must demonstrate that is fulfilling the promise of Prop. 71. Juggling those two goals is a difficult task but one that CIRM must master.

UC Irvine Looking for CIRM Grant

Leverage is everything. That is one $10 million lesson that a bond fund manager is delivering to the California stem cell agency.

Bill Gross, founder of PIMCO, agreed to donate that much to UC Irvine for its stem cell research program. Two million will go immediately for staff and equipment. But the remaining $8 million is conditioned on matching funds.

A UCI spokesman says the school is looking for a grant from CIRM to achieve that goal.

Here are links to stories on the grant: Los Angeles Times, The Associated Press, Orange County Register. Here is the press release from UC Irvine.

WARF Smacks Stem Cell Watchdog

WARF says California is trying overtake Wisconsin as the national leader in stem cell research by using its patents unfairly and illegally.

The organization took that position in an op-ed piece in the Wisconsin State Journal last week. It was written by Carl Gulbrandsen, managing director, and Elizabeth Donley, general counsel.

They wrote:

"In a guest column on (June 26)Monday, John (M.) Simpson of the California-based Foundation for Taxpayer and Consumer Rights argued that the Wisconsin Alumni Research Foundation is impeding life-saving research.

"Nothing could be further from the truth."

Among the evidence they cited for their position was an analysis of ESC research articles published worldwide between 2002 and 2005 that showed that 67 percent of those articles cited Wisconsin's stem cell lines. What that also shows is dominant market share – not as strong as Microsoft's but very strong. (Now there's an interesting question: How is WARF like Microsoft?)

They continued:

"In short, California wants to benefit from stem-cell science by using patents and licenses created using Wisconsin's patent rights to overtake Wisconsin as the national leader in stem-cell research. That is an understandable goal. California also want to do so without recognizing the contributions of Wisconsin's scientists, which may be understandable, but is not fair or legal."

Simpson authored another op-ed piece in The Sacramento Bee, which is nearly identical to his earlier piece in Wisconsin. However, it carried this additional paragraph.

"Earlier this spring, Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation, told a CIRM committee meeting that the patents are 'a major inhibition to productive scientific research.' Because of WARF's claims, Goldstein said, his foundation has funded scientists in other countries 'to create new and better stem cell lines, and that process … is currently flourishing.' U.S. companies interested in conducting stem cell research report they have had difficulty getting funding because of the WARF patent demands."

The Bee has a feature that allows its readers to comment online on op-ed pieces. Concerning Simpson's piece, one said,

"I hereby patent humanity! Anyone being born after today must send me 1 dollar, including any judges."

Obviously nobody should steal another's property, but in this case WARF may have difficulty in communicating its message to the public.

Upcoming CIRM Events

Monday July 10 -- Meeting of the Strategic Planning Advisory Committee in San Francisco at CIRM headquarters. A progress report is planned as well as discussion of technologies for stem cell research. Plans for the July 13 scientific conference and the July 25 commercial sector meeting are also on the agenda. No remote access is available.


Thursday July 13 – "The Scientific Challenge: From Basic Science to Clinic," daylong strategic planning conference in San Francisco. Five speakers scheduled on the agenda. No remote access is available.


Friday July 14 -- Intellectual Property Task Force meeting in Sacramento. Only one topic is on the agenda: consideration of public comments on the IP policy for nonprofits. That policy was approved last February by the Oversight Committee but is now going through the formal state adoption process. Remote access to the meeting is available at UC Irvine.

Stem Cell Legal: Fishing for Another Judgment

The folks who have failed in their legal attempts to exterminate the California stem cell agency are trying another tack.

This time they want to halt funding of CIRM grants to the University of California on the grounds that such funding amounts to an illegal conflict of interest because nine members of the 29-member body approving the grants had ties to UC.

The action in Sacramento County Superior Court is just a retread of the CIRM foes' earlier attempt in Alameda County Superior Court, a move that was rejected by a judge in a very brief trial and is now on appeal.

While providing lip service to legal arguments, the CIRM foes have made it clear that their primary motivation for their action is their religious opposition to embryonic stem cell research. They have also made it clear that if they cannot prevail legally, the next best thing is to force the agency and now the University of California and the state Controller to waste time and money on frivolous lawsuits.

We would have more tolerance for their legal positions if we had not witnessed their performance in last February's trial. They were unprepared and appeared to have failed to do basic research that could have bolstered their position.

We should note that litigation in America serves a variety of purposes aside from settling legal disputes. One is to stimulate media and public attention. Another is to stimulate the constituencies of the organizations involved in the legal action. Those are important objectives for the CIRM foes.

The Web site California Politics Today, run by Marc Strassman, was the first to report the latest lawsuit. Here are links to his two stories on the subject (the first one and the follow the next day). Here is a link to the legal filing.

Other than Strassman's piece, we have not seen any other coverage of the latest lawsuit.

Business To CIRM: We Need More Money

The California stem cell agency's plans for sharing the swag from research by nonprofits is drawing fire from the for-profit sector.

The national Biotech Industry Organization has complained in a letter to CIRM

:"These provisions substantially reduce or eliminate the incentives to commercialize patented stem cell-related technologies and products even in spite of the generous funding provided by Proposition 71."

Reporter Steve Johnson of the San Jose Mercury News reported the complaints from private sector, which were obtained from CIRM after the Mercury News filed a request under the public records act. Also registering complaints were the California Healthcare Institute, a biomedical industry group, and several biotech firms including Applied Biosystems of Foster City, Ca.

On the other hand, the California Council of Churches complained that the nonprofits would receive too great of a share of income from inventions from state-financed research.

Johnson's story also makes it clear once again that CIRM's initial approval of regulations is far from the final action. After the Oversight Committee approves them, they must go through the official state administrative proceedings allowing for additional comments and changes. That is the current stage for the nonprofit research rules, which were approved by the Oversight Committee last February.

Stanford Bioethicist Says More Monitoring Needed on California Stem Cell Research

Stanford bioethicist David Magnus says that the research rules of the California stem cell agency "lack adequate monitoring mechanisms."

His views were reported briefly in a recent piece in the Technology Review by writer Emily Singer in an article entitled "Lack of Human Eggs Could Hamper US Cloning Efforts."

Singer wrote:

"Unlike other types of human research, there are no U.S. federal guidelines governing how these experiments should be carried out. President Bush severely limited federal funding for embryonic stem cell research in 2001, including all research involving the creation of new stem cell lines. This has meant that the National Institutes of Health, the nation's largest source of biomedical funding, has not played its normal regulatory role, and individual states and research institutions have had to pick up the slack. "If there were agreed-upon national standards, it would probably speed up much of this protocol approval process," says Arnold Kriegstein, director of UCSF's stem cell program.

"Both Massachusetts and California, the latter via the California Institute of Regenerative Medicine, have recently enacted rules governing embryonic stem cell research. Both sets of guidelines prohibit paying egg donors, but do allow compensation for direct expenses, such as childcare and transportation. California takes it one step further, allowing women to be paid for time off work. It's unclear if Massachusetts law permits this practice.

"David Magnus, a bioethicist at Stanford University, says these regulatory systems lack adequate monitoring mechanisms, though. 'I think it would be an advantage to think about ways to make sure researchers are doing what they say they are going to do,' says Magnus. 'I would guess that we won't see problem with the first few institutions, which have been very careful. Problems would more likely occur down the road, when [nuclear transfer research] starts to become routine.'"

We asked Magnus for further comment on his statement. He responded:

"I made a general point and said that the CIRM rules are similar to most of our research participant protection system, which focuses on informed consent documents, protocols, etc. and very little on monitoring. We could, for example, do quality control activities that other industries have, such as taping some informed consent sessions to determine if that actual consent process does what it is supposed to do (the studies of this sort that have been done have found some problems that could be eliminated). We could also build in studies of the informed consent process into a lot of the research that gets conducted. At this point the CIRM guidelines are actually completely silent on issues that will arise in clinical trials."

Magnus also has more to say about informed consent procedures in the transcript of the June meeting of the ESC advisory committee for the California Department of Health. The group is formulating rules for ESC research in California that is not funded by CIRM.

Magnus cited informed consent procedures involving gene transfer research. He said,

"If you think of gene transfer research as a comparable, cutting-edge research, that’s a good analog to what we are talking about. There’s a lot of empirical studies about how that’s done, and the IRB’s are clearly not doing a good job. Because if you look at informed consent forms that went through IRBs, they’re full of misleading language.....There are maybe two or three studies published in the past year or two about informed consent forms and how awful they are. And that does not even count how - what actually happened in the actual consent process verbally where there’s not as much data, but what has been collected was terrible."

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Protection of Egg Donors Heading for Governor's Desk

Legislation aimed at protecting women who donate eggs for stem cell research in California – except for research financed by CIRM – cleared a state legislative committee and appears headed for the governor's desk.

The measure – SB1260 by Sen. Deborah Ortiz, D-Sacramento – was approved on a 12-0 vote earlier this week. It now goes to the Assembly Appropriations Committee, where it is likely to be sent on to the Assembly floor.

Ortiz' office issued the following statement:

"'Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans,' Ortiz said. '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.'

"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of potential risks and provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production (AOP) procedures. The bill limits, in accordance with the National Academy of Sciences, compensation to only allow reimbursement for direct expenses. It also provides payment for expenses associated with any necessary pre and post-procedure medical care.

"The bill will provide a streamlined set of standards for egg donations and continue state oversight that began in 2003 with SB 322 by Ortiz. Under SB 1260, an advisory committee created by SB 322 will finish making recommendations to the Department of Health Services (DHS) so that DHS may develop stem cell research guidelines for reviewing stem cell research projects."

The Health Services advisory committee has said it "is concerned with the designation of the IRBs (institutional review boards)as regulatory bodies of stem cell research, the breadth of the requirement for provision of medical care for adverse medical consequences of donating oocytes for research purposes, and the broad and ambiguous restrictions on who may be a research oocyte donor," according to the latest legislative analysis of the bill.

China No. 1 on ESC Spending, except for California?

Earlier this spring, some members of the California stem cell agency's task force on intellectual property wondered about the size of funding worldwide for embryonic stem cell research, excluding the United States.

The answer seems to be something in the neighborhood of $600 million annually, but that figure could well be low. The total is derived from a report on the CIRM Strategic Planning Site, which reviewed research activities in a number of countries. The report seems to confirm the conventional wisdom that CIRM, at $300 million-plus a year, would be the world's single largest source of funding for embryonic stem cell research.

The CIRM document is called "Overview on the Current State of the Development of New Human Embryonic Stem Cell Lines." The document is heavily qualified and "is not intended to be comprehensive or exhaustive." For example, some of the funding reported is current only as of 2004. And it is not entirely clear whether some of the numbers include funding for non-embryonic stem cell research.

Squishy as the numbers may be, they do provide a window on the size of programs in various countries. The CIRM staff report did not attempt to come up with a total or a ranking, a task attempted by the California Stem Cell Report. Our results are filled with caveats to numerous to mention.

China appears to have the largest annual program with a total as high as $249 million with the United Kingdom following at about $193 million, although it is not clear that all of the UK funding is available. Likewise, China's spending may be less.

Australia comes in at about $47 million, Singapore at $25 million, Korea at $18 million, Canada at $17 million, Israel at $7 million, Sweden at $2.2 million and India at $1.9 million. You may think some of these numbers seem strange. So do we, for a variety of reasons.

For example, Singapore has created a $600 million fund to invest in cutting-edge life science projects, including stem cells. But it is not clear from the document whether any of that money is included in the $25 million total for stem cell research expenditures.

Singapore is also involved with Australia in an endeavor called ES Cell International Pte Ltd. (ESI). It is not clear how the funding for that group is split between the two countries.

Other examples could be cited. But this is a rough cut. Many other interesting bits of grist can be found in the document.

Correction

In a June 20 item, we incorrectly described the Wisconsin State Journal as the Madison State Journal.