UC Officials Call for Open Access to Taxpayer Financed Stem Cell Research

Around the world, public health scientists are struggling to gain access to research that will help them stave off a catastrophic outbreak of bird flu.

University libraries are rebelling against annual subscriptions to scientific journals that run upwards of $3,000 annually.

Patient advocate groups complain that scientists are not sharing their research, delaying the development of cures that can save lives.

It is all part of the backdrop of the debate over the innocuous sounding topic of open access, which will come before the Intellectual Property Task Force of the California stem cell agency this Thursday.

The informational presentation is tied into decisions that CIRM is making concerning who will have access to the research it finances, how the research will be distributed and how much the public (including scientists) will have to pay for it.

The subject is of great interest to more than one member of CIRM's Oversight Committee. But Jeff Sheehy pushed hard to have open access placed on the IP agenda this week.

After representatives of the University of California plumped for the issue at an IP Task Force meeting last month, Sheehy was emphatic. He said,

"This is really important for patients....An activist list serve that I'm on, they're looking at purchasing subscriptions so that people can get access to the data.

"We give up our bodies so people can study us....The state of California is paying for this research. And from a patient perspective, the idea that a study would be published with CIRM funding, having used California residents potentially as subjects of experiments, and we could not read those studies, we cannot access them is just unconscionable."

Appearing before the Task Force were John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate.

We queried Ober later for more on the issue. He cited a May 2005 letter by UC President Robert Dynes to Robert Klein, chair of the CIRM Oversight Committee, seeking an open access policy. The information provided by Dynes said an open access policy would achieve several important goals, including the following:

"Accelerate research progress and provide California’s public access without cost to a collection of published results of taxpayer ...funded research.

"Create a stable and permanent California-based archive of peer-reviewed research publications and source data to ensure the permanent preservation of these vital research findings.

"Secure a searchable collection of peer-reviewed research publications that (CIRM) and the ICOC can use to manage its research portfolio and measure scientific productivity and progress."

Perhaps the foremost advocate of open access is the Public Library of Science. See its open access section for even more on why it says "everything we publish is freely
available online for you to read, download, copy, distribute and use (with attribution) any way you wish."

CIRM Working Group Member Wins a MacArthur

Born in Normal, Ill., one of six children, he is a mountain climber who was freaked out by medical school. So he became one of the most skillful mouse cloners in the country, according to those who know.

He is Kevin Eggan, also a member of the Standards Working Group of the California stem cell agency. And today he became one of the winners, at age 32, of the MacArthur Foundation grants given each year to the quite bright.

Eggan's official occupation is principal investigator at the Harvard Stem Cell Institute.

He recently said:

"Doing a nuclear transplant is like playing the most difficult video game in the world. Imagine building your own Xbox before you play, and the game hardly works. It's like in Super Mario Brothers, where you have to do it over and over again until you master it."

As a MacArthur fellow, he will receive $500,000 over the next five years.

For more on Eggan, see the following stories: Mouse cloner, mountain climber and French cook and medical school refugee.

News Briefing Tomorrow on Stem Cell Issues

The Center for Genetics and Society is putting together a briefing tomorrow on stem cell issues and politics for editors and reporters across the country.

The conference call session, set for 10 a.m., will deal with exaggerations, stem cell technology, existing and proposed policies as well as shifting political alignments. Top officials from the nonprofit watchdog group will take part in the conference call, whose topic is the "politics of stem cell research in an election year."

The center supports embryonic stem cell research but has been critical of the California stem cell agency. It describes itself as an advocate of "responsible societal governance of the new human biotechnologies." In addition to its activities regarding CIRM, the center has also spoken out on stem cell issues elsewhere around the nation.

Richard Hayes and Marcy Darnovksy, executive directors of the group, recently authored the book, "Stem Cells and Public Policy."

For more details on tomorrow's conference call, email pshah@genetics-and-society.org.

Hundreds of Millions at Stake? Draft CIRM IP Policy for Business Now Available

The 37-page "deal" for businesses seeking grants from the California stem cell agency – at least the preliminary version of it – is now ready for some flinty-eyed dissection.

CIRM has posted the draft on its web site ahead of Thursday's meeting of its Intellectual Property Task Force in San Francisco.

The document grew out of the Aug. 29 meeting of the Task Force, chaired by Ed Penhoet. He says he wants to bring recommendations to the Oversight Committee Oct. 11 for its approval.

No one knows how much money could be at stake in connection with CIRM's plans for sharing the wealth with businesses, but it could be rather large. The agency itself could eventually give hundreds of millions of dollars to businesses to stimulate the development of stem cell therapies.

The IP proposals appear to be line with the principles offered on Aug. 29. The draft also attempts to clarify such terminology as the meaning of net revenue – important because the draft contains a 17 percent net revenue trigger on one revenue sharing feature.

The draft offered a little more detail on the "blockbuster" payments on successful commercial products. It proposed a payment equal to three times the original award(inflation adjusted) – paid back over five years – after revenues exceed $250 million.

Also clarified was the percentage of funding that would trigger a requirement that awardees provide a plan for access to CIRM-assisted therapies for uninsured Californians. The proposed figure is 25 percent of the funding of the invention or project. That would also kick in a requirement to provide the therapies to public agencies at the Medicaid price. However, some members of the Task Force say there is no such thing as the Medicaid price.

Oversight Committee member Duane Roth says California businesses need certainty in any proposal that requires financial commitments. They need to know "that this is the deal," he says.

Whether businesses on Thursday will make any counter offers on the deal is unknown. But only a handful were on board for the meeting last month.

A side note: Penhoet and the CIRM staff, especially Mary Maxon, well served the stem cell community, businesses and public by having the IP draft up on the web site last Friday. Also up was the transcript of Aug. 29 meeting. Early postings genuinely help all involved make intelligent and timely contributions to the discussion.

Love and Reed Mentioned in Massachusetts Political Coverage

The names of two members of the directors of the California stem cell agency have surfaced in coverage of the Massachusetts governor's race.

Ted Love and John Reed were mentioned in a story by reporter Dave Wedge of the Boston Herald that said that a company founded by the Democratic candidate, Chris Gabrieli, is "one of the world’s leading patent holders in stem cell research, raising questions about (his) denials that he stands to profit from his plan to fund the controversial science with tax dollars."

Wedge wrote:

"Isis Pharmaceuticals - a company in which Gabrieli owns $1.5 million in stock - ranks third in the country in stem cell patents. Gabrieli sat on the firm’s board of directors until February."


Wedge continued:
"The controversy came to a head (last week) when (Republican candidate Kerry) Healey launched an attack ad accusing Gabrieli of positioning himself to reap a financial windfall from his plan to invest $1 billion in taxpayer money in stem cell research.

 "The Herald also has learned that Gabrieli has ties to two biotech executives who have come under fire in California for sitting on an independent board that oversees that state’s $3 billion, taxpayer-funded stem cell research program. Gabrieli has called the California program a 'model' for his Bay State plan.

"Ten of the 29 executives on the California board have been criticized for their investments and interests in biotech companies, including Isis Pharmaceuticals director John Reed. The other with ties to Gabrieli is Ted Love, a board member of Predix Pharmaceuticals, a company that recently merged with Epix Pharmaceuticals, which is in Gabrieli’s investment portfolio."

'Desperate Companies, Delusional Researchers'

The Center for Genetics and Society, which is practically a next-door neighbor to Advanced Cell Technology, has published a critical assessment of the company in connection with the latest controversy involving ACT's new stem cell extraction method.

The piece also reviewed ACT's previous announcements of research that did not fully pan out, including details that we have not seen elsewhere.

The center wrote:

"What's been little remarked upon, however, is that this pattern of hyperbole has come to characterize both the field of stem cell research and the political debate about it. Miracle cures for myriad diseases are promised by proponents of work with embryonic stem cells. Early-stage research and even speculative applications of hypothetical research are promoted to garner public support and venture capital. Researchers in white lab coats pitching the potential of embryonic stem cells are identified only as research scientists, when in fact they are often also the financial beneficiaries of biotech corporations. Meanwhile, reasonable and minimal regulations are criticized as thwarting scientific progress.

"Given this climate of exaggerated expectations, it shouldn't be that surprising that desperate companies and delusional researchers regularly come along, and take advantage of the public's hopes and misperceptions in order to boost their stock prices or careers."

"In this case, the weak link was the media, on whom the public relies for accurate and critical reporting. Instead of reading the scientific paper closely—which would have revealed that the embryos were destroyed—most reporters took the press releases issued by ACT and Nature at face value. Given ACT's sketchy history of swindling, seasoned journalists should have known better."

As for the physical location of the center and ACT, CGS is in Oakland which is linked by an underwater tunnel and draw bridges to the island (Alameda) in San Francisco Bay that houses ACT.

CIRM's Financial Watchdogs Vote for Disclosure

Financial overseers of the California stem cell agency have decided not to seek an exemption from a state law that requires them to disclose their investments.

In a 4-1 vote, the Citizens Financial Accountability Oversight Committee decided to go along with the state's economic disclosure act that applies to most high level public officials, according to Garin Casaleggio, a spokesman for the state controller's office.

The only negative vote came from Myrtle Potter, a former executive in the biotech industry.

Prior to the meeting, the committee appeared to meet the qualifications for becoming the fourth state agency to be exempted from the disclosure law. The exemption provision was enacted only this year, which allowed the Commission on the Fair Administration of Justice, the Medication Errors Panel and the Alliance to Combat Trafficking and Slavery Task Force to be excused from normal financial disclosure.

The financial oversight committee held its first meeting ever last Thursday in San Francisco and reviewed the audit of CIRM by its contracted auditor as well as the controller's review of the audit. According to Casaleggio, the panel endorsed the recommendations in those audits, which CIRM has already basically implemented.

Democratic state Controller Steve Westly, chair of the panel, requested that CIRM "explore a streamlined grant process that would spur collaboration and innovation by requiring scientists to share research results," according to a press release. The release also said:

"Westly recommended the Institute’s Intellectual Property Committee review and report on the policies of research organizations that earmark a portion of research funding for grants that require annual disclosure of results."

Casaleggio told the California Stem Cell Report that the financial committee will receive a report from the controller's staff on CIRM's IP policy at its next meeting.

The committee indicated that it would meet again as soon as the second financial audit is available, perhaps in December. By that time, the state's auditor general may have completed its performance audit of the agency as well.

Casaleggio said about 40 persons attended the meeting, presumably including staff from both the controller's office and CIRM as well as a news crew from San Francisco TV station KGO, which was the only other news outlet beside this website to publish a report on the session.

For more on the disclosure exemption question, see "no time to weaken." See the item below for more on the ongoing dispute on one member's qualifications as well as the Political Muscle blog by Robert Salladay on the Los Angeles Times website.

FTCR: Lockyer Should Dump CIRM Financial Overseer

California Attorney General Bill Lockyer should oust a former lobbyist for the California Teachers Association from the panel that oversees the financial dealings of the California stem cell agency, a watchdog group said today.

The Foundation for Taxpayer and Consumers Right called on Lockyer to disqualify John Hein from his position on the Citizens Financial Accountability Oversight Committee because Hein did not meet the legal requirement that he have a medical background.

John M. Simpson, stem cell project director for the Santa Monica group, said in a press release that CTA had contributed $526,200 since 2003 to campaign organizations linked to Democratic Assembly Speaker Fabian Nunez, who appointed Hein in December 2004. (We should note that it is unlikely that the money is a quid pro quo involving the appointment. Nonetheless, Nunez and the CTA are politically close.)

Simpson said,

"When you are appointed to an important position without the qualifications, it's a political payoff. It's clear Hein got this position because of the California Teachers Association's political clout."

According to a San Francisco TV station, Nunez stands by his appointment. Hein told the station, KGO, that he did not have a medical background, saying that he also told that to Nunez.

Nunez' office has not responded to inquiries for comment from the California Stem Cell Report.

Stem Cell IP for Business Coming Up on Thursday

The California stem cell agency is close to approving rules for dividing up the booty from therapies developed by businesses as a result of grants from CIRM.

That is the central issue next Thursday afternoon at a session of the agency's Intellectual Property Task Force. Next stop for the IP rules is the Oversight Committee meeting Oct. 11, which makes the final call.

So if you represent a business with a stake in this issue, now is the time to make your voice heard.

The specific agenda item involves a draft IP policy that is based on principles approved at an Aug. 29 meeting of the Task Force. As far as we know, the California Stem Cell Report is one of only two media to carry a report on that session, including some of the details of the principles. You can find our report here. Here is a link to the other, stemcellbattles.com.

CIRM has not yet posted the draft of its proposed policy on its web site. We will let you know if and when it becomes available.

Also on the Task Force's agenda is a presentation on open access policies for scholarly articles published by CIRM grantees. This is a far-reaching issue. We will carry a preview on the matter in the next few days.

Remote access to the San Francisco meeting next week is available in Chico, Irvine, Elk Grove and La Jolla.

Stem Cell Research Regulations Up Next Week -- But Not CIRM's

Regulations for California embryonic stem cell research that is not funded by CIRM are the topic at a meeting next Wednesday by advisory panel to the state Department of Health Services.

The group has been working since last winter on the proposals as the legislature debated and passed related legislation (SB1260) by Sen.Deborah Ortiz, D-Sacramento. That bill is now before governor for his signature or veto.

The meeting is in Oakland but the committee has created a toll-free conference line that is available to members of the public who wish to participate wherever their geographic location, a move to be commended.

For those of you who think it is odd that there are two sets of rules for stem cell research in California, that is a function of the initiative process that created the stem cell agency. It is governed by the provisions of Prop. 71, which did not undergo the normal legislative process and which is virtually untouchable by the legislature or the governor. ESC research not funded by CIRM is governed by a state law that was passed by the legislature and signed by the governor.

Transcripts and minutes of previous meetings can be found here.

Latest on Legal Qualifications of CIRM Financial Overseer

State Controller Steve Westly plans to seek a legal opinion about whether one of the appointees to the board that oversees the finances of the California stem cell agency is legally qualified.

The man in question is John Hein, a former lobbyist for the California Teachers Association. He was appointed to the Citizens Financial Accountability Oversight Committee by Assembly Speaker Fabian Nunez nearly two years ago..

The Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., challenged the appointment and called on Hein to resign because he does not have the medical background as required by Prop. 71.


David Louie, reporting for San Francisco television station KGO, said,

"Hein turned down an on-camera interview. However, he acknowledged he has no medical background. And he said he pointed that out to Assembly Speaker Nunez.

"A spokesman for Nunez says he stands by the appointment and believes Hein's experience in health care issues and managing health care contracts qualifies him.

"State Controller Steve Westly will seek a legal opinion of Hein's appointment.

"Steve Westly, (D) State Controller: 'Mr. Hein certainly has a deep financial background, and we welcome him on the committee. We will ask him to talk with the attorney general's representative to make sure his being part of this is in compliance with the law.'"

As for other matters on the agenda of the committee, we have an inquiry into the state controller's office.

Text from ACT's Ethics Chair to U.S. Senate Subcommittee

Last week officials of Advanced Cell Technology of Alameda, Ca., appeared before a U.S. Senate subcommittee and were scolded by two U.S. Senators in connection with ACT's extraction announcement last month. Here is the complete prepared text of Ronald M. Green, director of Dartmouth's Ethics Institute and chair of Ethics Advisory Board to ACT, to the Senate Labor, Health & Human Services and Education Appropriations Subcommittee. The statement of Robert Lanza follows this item. Both statements were supplied by ACT at the request of the California Stem Cell Report.

(September 6, 2006) Good morning, Mr. Chairman and distinguished members of the committee. My name is Ronald M. Green. I am a professor at Dartmouth College and Director of Dartmouth’s Ethics Institute. I also serve as the chairman of Advanced Cell Technology’s Ethics Advisory Board. I would like to emphasize that I am a university-based bioethicist and that I have no financial interest whatsoever in ACT’s technology.

I believe that the method of stem cell derivation announced by ACT researchers in their August 24 report in the journal Nature represents a real opportunity to move human embryonic stem cell research forward in this country in a way that respects the ethical sensitivities of the vast majority of our citizens.

Dr. Lanza has already touched on some of the key ethical issues. He has stressed how this research could be conducted in the context of preimplantation genetic diagnosis(PGD) without adding any additional risk of harm to the embryos involved in this procedure.

Dr. Lanza has also shown that the extracted individual cells cannot reasonably be regarded as individual or independent human beings. No cells extracted at this stage of embryonic growth could go on to full term development.

There are two remaining ethical concerns that I would like to address. First, there is the connection between this new method and both IVF and preimplantation genetic diagnosis (PGD). Some people object to both these technologies because they involve the manipulation of embryos and because parents using these procedures can elect not to implant some of the embryos produced in this way. But this objection is made by only a small minority. The overwhelming majority of Americans support both procedures. IVF helps infertile couples have children and PGD allows those who carry dread genetic diseases to have healthy children. Both procedures help people have children that otherwise would never have been conceived or born. In this respect, both are profoundly “pro-life.”

Second, there is the concern that the embryos used in this research did not survive the experiment. Since the publication of the Nature report some critics have emphasized this fact even though it remains true that the method developed by ACT scientists requires no further destruction of any embryos. I would like to point out that because this research was privately funded, this experiment was legal. It was also approved by ACT’s Ethics Advisory Board and by an additional institutional review board that was mandated under Massachusetts law. The embryos used were donated by people who had fully consented to the research and understood, and even required, that the embryos would not be allowed to go on to further development.
It is not unique that the initial research needed to develop morally acceptable methods or materials do not meet everyone’s approval, but this does not impugn the methods or materials produced as a result of that research. One example is the polio vaccines we use today. Some of the initial research on these vaccines was conducted with a technique that required the use of tissues from aborted fetuses. Later, this approach was replaced by other methods.

Almost no one today refuses polio vaccination for their children on the grounds that they object to the methods used in the first experiments. I would point out that even President Bush has been willing to use the harmless downstream results of research to which he objects. All of the stem cell lines being used in federally funded research today were produced by embryos that were destroyed for this purpose before the President’s August 2001 directive. The President could have said that none of these lines should be used because they were created in a way he regards as morally objectionable. But he did not. He concluded that so long as no future harm is done, this valuable resource could be used.

Thanks to this research breakthrough, we are in exactly the same position today. If Congress were to approve legislation that funded research on lines generated by this new method, and if President Bush were to permit such legislation to pass into law, both the members of Congress and the President could honestly turn to the American people and say that no human embryo ever again needs to be harmed or destroyed to produce the stem cell lines we need for federally funded research.

Many scientists believe that we need several hundred new federally funded stem cell lines in order to have the genetic diversity needed for research. Well over 2,000 PGD procedures are conducted in this country each year. If just one out of three of the couples using this procedure authorized the harmless derivation of a cell line from the extracted cell of each of the embryos they chose to implant, we could produce at least fifty new cell lines every year from now on. The derivation of these cell lines would cause no harm to any of the donor embryos, a fact of critical importance for both the ethical and legal authorization of this research.

Let me conclude by stating that I am not a scientist. Although I have been impressed by the quality and the integrity of ACT scientists, their work will have to be replicated by other researchers before we can say that it is ready for wide use. But if Congress begins the legislative initiatives to test this method and fund research based on it, we can begin to move toward the kinds of cures and therapies that stem cell research promises.

Text From Lanza's U.S. Senate Appearance

Last week, Robert Lanza of Advanced Cell Technology of Alameda, Ca., appeared before a subcommittee of the U.S. Senate. Two U.S. senators excoriated him in connection with ACT's announcement of a new method of extracting ESC. Here is the complete text of what Lanza prepared for the Senate Labor, Health & Human Services, and Education Appropriations Subcommittee. The text was supplied by ACT at the request of the California Stem Cell Report.


(September 6, 2006) Good morning, Mr. Chairman and distinguished members of the committee. My name is Robert Lanza and I am Vice-President of Research & Scientific Development at Advanced Cell Technology, a biotechnology company in the field of regenerative medicine. I am also an Adjunct Professor at the Institute of Regenerative Medicine at Wake Forest University School of Medicine.

I would like to thank you for the opportunity to testify today on our technique for obtaining human embryonic stem (hES) cells from single blastomeres. As you know, hES cell lines are conventionally isolated from leftover embryos created for couples seeking in vitro fertilization (IVF). I join with the sponsors of Senate Bill HR 810 in my belief that scientists funded by the NIH should have access to stem cells derived from the hundreds of thousands of such surplus embryos that will otherwise be discarded. I know that you share my frustration that this important legislation was vetoed by the President.

Therefore, at the outset, I would like to make it absolutely clear that the single-cell derivation technique we’ve developed is not a replacement for existing methods of generating embryonic stem cell lines. In fact, our intention is quite to the contrary. We think it would be tragic not to pursue all the options and methods currently available to us to get this technology to the bedside as soon as possible. That being said, our hope is that the new method we describe in Nature can be used to increase the number of stem cell lines that qualify for Federal funding within the framework of existing US laws and regulations – and thus give the field a very much needed jump-start.

Current US law prohibits the use of federal funds for research in which human embryos are harmed or destroyed. As a result of this policy, the field of stem cell research has been crippled by the lack of quality stem cell lines. At present, there are only a handful of NIH-approved lines, all of which are potentially contaminated with animal pathogens that could lead to serious health risks; whereas others are difficult to grow and have started to display genetic abnormalities. Nor do they reflect the genetic diversity of the population, both in terms of their clinical potential and their value to those of us trying to understand the cause of various human diseases.

The approach we have developed does not involve the destruction of embryos, nor do the biopsied cells ever develop into an embryo at any point. The procedure is commonly known as PGD (preimplantatation genetic diagnosis) and is a well-established technique that has been used for a decade by IVF clinicians to generate thousands of healthy babies worldwide. In PGD, a single cell – known as a blastomere – is removed from an 8-cell-stage embryo for genetic testing. By growing the cell overnight, the resulting cells could be used for both PGD and the generation of stem-cells without affecting the clinical outcome of the procedure or the subsequent chances of the couple having a child. Numerous reports show that the survival rate is unaffected by the biopsy procedure, and that the subsequent development and chances of implantation are the same for both normal and biopsied embryos In our study, multiple individual cells where removed from embryos in the same way as would be employed in the clinical setting with PGD. Although those particular embryos were not allowed to develop further, we also carried out studies which confirmed that the biopsy procedure we used could be used without destroying the embryo. I want to be entirely clear on this point. The embryos used to create stem cell lines in our study were destroyed; however, in control experiments, single-cell biopsied embryos were allowed to continue development, and they did indeed develop to a more advanced (blastocyst) stage – they were all frozen and remain alive.

In fact, they continued development at the same rate as nonbiopsied embryos. We also showed that individual biopsied cells had the capacity to generate stem cells. Nineteen ES-cell like outgrowths and two stable embryonic stem cell lines were derived from 91 blastomeres. These stem cell lines have been growing for more than 8 months, and are genetically normal and able to generate cells from all the germ layers of body, including nerve cells, blood cells, and even retinal cells that could be used to prevent blindness.

Of course, hES cells derived this way could be of great potential benefit, not only for the medical research community, but also for the children and siblings born from transferred PGD embryos as well. The cells would be genetically identical to the child, and could be frozen down and used throughout the lifetime of the person – for instance, if they develop diabetes or heart disease.

I would now like to address several objections to the use of this procedure. First is that the technique may not be entirely without risk to the embryo, however minimal. We agree, and until remaining doubts about safety are resolved, we do not recommend the procedure be applied to healthy embryos outside the context of PGD. However, in PGD a cell is already removed and could be used to create stem cells without any added risk to the embryo. Second, concerns have been raised as to whether individual cells, such as those used in our study, are totipotent and could potentially generate a human being. It is our opinion that this is not the case.

Recent reports show that cell fate is already being determined at the 2 to 4 cell stage. Importantly, individual cells from an 8-cell-stage embryo, such as those used in our study, have never been shown to have the intrinsic capacity to generate a complete organism in any mammalian species – not even in a mouse or rat. And finally, questions have been raised whether the technique is completely applicable in the clinical setting. We believe it is and are working on procedures that can be utilized by clinicians in the IVF clinic environment. And thus, we believe it is now possible to create new stem cell lines without destroying human embryos. With the support of Federal funding, the single-cell derivation technique could provide new robust (and animal-product-free) stem cell lines for medical research and human clinical trials.

Since I testified here a year ago, we’ve managed to move the singlecell derivation technique from the mouse to the human. But in the meantime another million people have died of diseases that could potentially be treated – and possibly cured—using future stem cell therapies. How long are we going to allow this intolerable situation to continue? Stem cell scientists sorely need more lines that qualify for Federal funding. Make no mistake about it, there are many promising alternatives out there, but the conventional and singlecell derivation techniques are a reality – here and now. There are those who would want to set this research back, but there is a very real human tragedy out there, and it would be a shame not to use this opportunity to try to lessen the misery of so many Americans with disorders and disabilities. This is my hope, and it could start here with this Committee. Now is the time to move, while the United States is still in the forefront of this research, and while there is still time enough to develop therapies that could be used to help alleviate the suffering of those we know and love.

Thank you for the opportunity to address your Committee. I hope you find these comments helpful to your work.

Feds Could Take Up WARF Stem Cell Patent Dispute Next Month

The U.S. Patent Office could announce some time next month its decision on whether to step into the multimillion dollar WARF stem cell patent controversy.

Writer Joe Vanden Plas of the Wisconsin Technology Network indicated that was the likely timetable in an article that also quoted WARF as saying it expects the Patent Office to review the challenge to the patents by the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca. However, the issue is not likely to settled for several years.

WARF's hold on stem cell patents has troubled some in the business for years. The California foundation filed its challenge after WARF said it wanted to charge the California stem cell agency for use of its patents because the state expected to generate royalties. At stake are potentially millions of dollars in royalties not only in California but throughout the nation.

Vanden Plas said that the Public Patent Foundation (which represents the California foundation) challenged the WARF patent on the basis of "what it said was unseen 'art' or evidence that the previous work of other scientists made the derivation of human embryonic stem cells obvious and therefore unpatentable."

Vanden Plas' article also briefly discussed the agreement reached between WiCell, an arm of WARF, and Advanced Cell Technology of Alameda, Ca., to disribute new stem cell lines involving ACT's new technique.

FTCR: Hein Should Resign from Stem Cell Panel

One of the members of the Citizens Financial Accountability Oversight Committee for the California stem cell agency, which meets today for the first time, is not qualified and was appointed as a "political payoff," a watchdog group said today.

The Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., said in a press release that the appointment of John Hein by Democratic Assembly Speaker Fabian Nunez "smacks of cronyism and the pay-to-play culture that dominates California politics."

John M. Simpson, stem cell project director for the foundation, noted that Prop. 71 requires members of the oversight committee to have "medical backgrounds and knowledge of relevant financial matters."

Hein was a longtime lobbyist for the California Teachers Association and now heads the political and policy consulting firm of HC&A of Sacramento, Ca. Hein was also a key negotiator in the education deal with Gov. Schwarzenegger that collapsed a few years back.

Calling on Hein to resign, Simpson said the CTA, a politically influential union in California, has been a longtime backer of the Nunez and contributed $12,800 to Nunez in election cycle preceding Hein's appointment.

Wanted: Fresh Human Eggs

What is the going price for human eggs these days? It runs as much as $50,000. But there are still not enough eggs to fuel the stem cell research machine, according to two articles in the Los Angeles Times today.

Reporter Karen Kaplan wrote:

"While the world debates the morality of stem cell research, scientists are grappling with a more basic issue — a shortage of eggs that they say is crippling their work."

One example that Kaplan reported involved Advanced Cell Technology of Alameda, Ca. The company has used newspaper ads to recruit women, some of whom declined after learning they would not be compensated beyond expenses. Kaplan wrote:

"After 10 months, one woman has passed the physical and mental health exams. She was scheduled to begin the egg retrieval regimen last week and could have eight eggs ready to harvest in early October."

Reporter Lee Romney examined the California scene including legislation (SB1260) by Sen. Deborah Ortiz, D-Sacramento, and the California stem cell agency.

Romney discussed the issue of possible exploitation of women egg donors, particularly low income, minority women. She also quoted Radhika Rao, of UC Hastings College of the Law in San Francisco and a member of a state commission that crafted guidelines for stem cell research, as saying,

"If you pay women a lot and they're white, it isn't exploitation?"

The Unexpectedly (to some) Long Life of CIRM

When is a 10-year embryonic stem cell research program not a 10-year embryonic stem cell research program?

Answer: When it is the California Institute for Regenerative Medicine.

Confused? We were too. We have been operating under the mistaken impression that the California stem cell agency has a 10-year life span that began when voters created it in 2004. In fact, CIRM has life in virtual perpetuity. And it can fund itself with the state's general obligation bonds apparently until it hits the $3 billion cap. All of which raise some interesting questions about life after $3 billion.

Two years ago when Prop. 71 was approved, news accounts repeatedly referred to a 10-year period in connection with the agency. Sometimes the time span was linked with the ability to issue bonds. Sometimes not. But regardless of context, 10 years kept popping up. Even the economic report by the Analysis Group, which was paid for by the Prop. 71 campaign, referred to funding over 10 years. And today the web site of the Alliance for Stem Cell Research, a spin off from the campaign organization, uses the 10-year term. The ballot measure itself says the intent of the measure was to authorize funding over a 10-year period. However, the analysis of the initiative by the state's legislative analyst is clearer. It says:

"The measure states its intent, but does not require in statute, that the bonds be sold during a ten-year period."

The longevity of CIRM came up when we wrote an item that said only 60 percent of the agency's life span remained.

That prompted a response from Dale Carlson, chief communications officer for CIRM, who asked for a correction. He acknowledged that he too was once under the misapprehension that CIRM would pass on at age 10. He said,

"I seem to have inherited a common misconception that CIRM is authorized to exist for only 10 years. I assume that stems from language in Prop. 71 regarding the issuance of an average of $295 million in bonds over 10 years, or it may be a legacy from the campaign. Whatever the case, there is in fact no timeline or deadline or sunset provision in Prop. 71.

"We are authorized to issue up to $350 million in bonds in a single year. Anything short of that can be rolled over to subsequent years. We don’t expect the funding to remain constant year over year. Instead, we expect to set each year’s amount based on the state of our strategic plans, the current research environment, scientific advances, newly recognized needs and opportunities, etc. It will be a dynamic process. Many (if not most) of the grants we award are likely to extend out over several years.

"The litigation has an effect, of course. It delays the issuance of authorized public general obligation bonds. It does not mean, however, that we’ll be issuing more than $350 million in a single year to 'catch up', nor that our effective half-life is shortened. The litigation is likely to extend the CIRM’s life and funding program, to make up for the delayed issuance of GO bonds."

As we remarked earlier, all of this raises interesting questions about life after $3 billion, a date that may not occur until about 2017 or perhaps several years later.

Given the nature of organizations and bureaucracies, it is not likely that CIRM will want to close its doors after the $3 billion runs out. It will be an organism that will want to survive, and there may well be good reasons for its life to continue. The state could fund it through the budget process, but without the usual oversight it gives other state agencies, which do not have the constitutional independence that CIRM does. It could also turn to private fundraising, as it has done so already to the tune of $50 million. California's biotech industry may find it useful to provide hundreds of millions of dollars to CIRM to continue pursuing work that is basic to the well-being of the business. Of course, some folks might object to a state agency behaving in such a fashion. But CIRM is virtually immune to control by the governor or the legislature.

And then there is a provision within Prop. 71 that provides for use of "alternate financial plans" instead of state bonds if they would significantly lower borrowing costs.

Is there a lesson in all this? Just the usual. Never assume. Expect the unexpected. Re-read the rules and instructions. However, there may be some folks who will not be happy to find that CIRM has perpetual life.

Update on Legal Actions Against CIRM

Someone queried us the other day concerning the effort by the losers in California stem cell trial to overturn the verdict that favored CIRM. "What is going on?" was the question.

The answer: Not much.

As of Friday, the losers had failed to file their brief with the appellate court. Once that happens, presumably later this month, CIRM will file its response. Then the losers will get a chance to rebut.

In an interview today with the California Stem Cell Report, Tamar Pachter, the deputy attorney general handling the case for CIRM, noted, however, that the appeal is on an expedited calendar so the matter should move more quickly than normal appeals.

She also said that another action, originally filed in the Sacramento by the opponents of the agency, has been modified substantially. Originally the action sought to block CIRM training grants to the University of California on the grounds that they violated state law. That argument has been altered to contend that the grants violate only Prop. 71. Pachter said she expects that such arguments are likely to become commonplace as CIRM issues more grants.

Another Reason for Public Disclosure by CIRM Grant Reviewers

The California stem cell agency says that the scientists who make "recommendations" regarding who receives hundreds of millions of dollars in grants do not need to disclose publicly their financial interests.

On Sunday, however, the Los Angeles Times carried a piece that demonstrates again why public disclosure is needed.

Reporter David Willman wrote.:

"A senior researcher at the National Institutes of Health engaged in 'serious misconduct' by entering into dozens of unauthorized private arrangements with drug companies and failing to report annually the outside income, totaling more than $100,000, a confidential internal review by the agency has found.

"Officials at the NIH concluded late last year that the actions of Dr. Thomas J. Walsh, who has helped lead major clinical trials involving cancer patients, might result in dismissal from federal government service. No disciplinary action has been taken.

"The internal review, conducted by lawyers and other ethics specialists within the office of the NIH director, found that from 1999 to 2004, Walsh received fees totaling $100,970 from pharmaceutical and biotechnology companies. He accepted fees from 25 companies and has led government-sponsored research involving some of those companies' drugs."

In this case Walsh allegedly failed to disclose to NIH. One has to ask the question: Would public disclosure have prevented the alleged misconduct? That is impossible to tell, but it would have raised the importance of the issue to a higher level and added a deterrent component. It would have also led to critical oversight from various public watchdog groups that love to forage in public documents. With public disclosure presumably it would have taken less than five years for the alleged misdeeds to surface. (Five years, by the way, is about 60 percent of CIRM's remaining life.)

The Walsh story is not isolated. Conflicts of interests are widely reported in medical research and are probably impossible to avoid. All the more reason to bring the financial interests at play out into the sunshine.

As for the use of quotation marks around the word recommendation in the first paragraph of this item, the reviewers do make recommendations on the grants but those are virtually de facto decisions, a position that we acknowledge CIRM disagrees with.

Stem Cell Snippets: Starters to Strategic Planning

Links to interesting pieces and announcements involving California stem cell issues.

Stem Cell 'Starter' – The tale of Jennifer Cash, a UC Davis grad student and a worker well down the stem cell food chain. She is trying to concoct a stem cell 'starter' medium, according to a writer Sam Whiting in the San Francisco Chronicle.

Cautionary Piece – An Australian web site has a summary of an article that is called a "cautionary tale" about the California stem cell agency. The original article, by Tamra Lysaght of the University of Sydney, was published in the Journal of Bioethical Inquiry but is not yet available online.

CIRM Strategic Meeting – On Friday, CIRM will hold a meeting in San Francisco of its Strategic Planning Advisory Committee. The agenda includes a report on the Aug. 26 Diversity Focus Group Meeting and a progress report on the strategic plan.