Duplicate Publication: Journal Retracts Cha Article

The Fertility and Sterilityjournal has apparently retracted on grounds of "duplicate publication" a paper also involved in allegations of plagiarism by Korean scientist Kwang-Yul Cha.

The matter became of interest in California after the state's stem cell agency approved a $2.6 million research grant for a subsidiary of Cha's Korean organization.

Tony Knight, a spokesman for Cha, sent a copy of the press release announcing the journal's action to the California Stem Cell Report. The release, however, does not yet appear to be on the Fertility and Sterility journal web site. We have queried the journal concerning the information, which did not address the plagiarism allegations.

Here is the statement from Fertility and Sterility as relayed by Knight. A statement from Cha Health Systems follows along with a link to a piece in The Scientist magazine today on the matter.

"For immediate release: April 26, 2007

"The December 2005 issue of /Fertility and Sterility/ included an article entitled “Quantification of Mitochondrial DNA Using Real-time Polymerase Chain Reaction in Patients with Premature Ovarian Failure.” The article was originally published in the /Korean Journal of Obstetrics and Gynecology /(/KJOG/) in 2004, under a different title, with some authors different from those listed in the publication appearing in /Fertility and Sterility/.

"Based on the prior publication of the article, which is contrary to the standards of /Fertility and Sterility/ and medical and scientific publishing, /Fertility and Sterility /has decided to retract the article and will publish that fact in an upcoming issue of /Fertility and Sterility/. This decision was based only on the issue of duplicate publication and does not reflect on the scientific validity of the paper.

"Dr. Sook-Hwan Lee was listed as corresponding author of each version of the article. Dr. Lee has admitted responsibility for the duplicate publications of the article and states that none of the other persons listed as authors had knowledge that the article submitted to /Fertility and Sterility/ had been previously published in KJOG.

"After carefully considering the facts available to it, /Fertility and Sterility/ has determined that Dr. Lee will not be allowed to publish materials in /Fertility and Sterility/ for the period of three years. No action will be taken as to any of the other persons listed as authors of the /Fertility and Sterility/ article, Kwang-Yul Cha, MD, PhD; Hyung-Min Chung, PhD; Kwang-Hyun Baek, PhD; Sung-Won Cho, MS, and Kyu-Bum Kwack, PhD."

The Cha Health Systems statement said:

"The (journal) said its decision to retract the article was based only on the issue of duplicate publication. We were hopeful that the paper would not be retracted, but we are pleased that the board recognized its scientific merit. We have said from the beginning that Kwang-Yul Cha, MD, PhD; Hyung-Min Chung, PhD; Kwang-Hyun Baek, PhD; Sung-Won Cho, MS, and Kyu-Bum Kwack, PhD. knew nothing of the paper’s prior publication. We are gratified that the /F&S/ board reached the same
conclusion."

The Scientist magazine article on the matter did not contain information on the journal action, but said it had not made a decision on how to handle the plagiarism issue.

CIRM Legislation Advances in State Senate

The California State Senate Judiciary Committee today approved legislation aimed at ensuring that the state receives a return on its $3 billion stem cell research investment and that its citizens receive affordable treatments with any state-financed stem cell cures.

The measure, SB771, was sent to the Senate Finance Committee, its last stop before it reaches the Senate floor.

Sen. Sheila Kuehl, D-Santa Monica, told the committee that her bill merely "keeps the promises" of the Prop. 71 campaign. Sen. George Runner, R-Antelope Valley, co-author of the measure, said it ensures that the campaign was not a "bait-and-switch" effort. Runner also said it was "perplexing and disappointing" to hear opponents of the legislation complain that it would stand in the way of development of cures.

The measure was opposed by CIRM and the biotech industry as represented by the California Healthcare Institute. Their arguments were familiar to those who have read these pages and can be seen in much greater detail in items elsewhere on this Web site than time allowed in today's 15-20 minute hearing.

Kuehl said she was willing to work with CIRM but was not satisfied with its position that the legislation is premature. She the use of the "trust us" argument "is not attractive to me." She also noted that industry sounds as if it has a problem keeping the promises embodied in the Prop. 71 campaign.

Representing CIRM at the hearing was Francisco Prieto, a Sacramento physician and a member of CIRM's Oversight Committee. He reiterated CIRM's position that the legislation was premature and said the agency was making progress in meeting the promises of Prop. 71. Runner indicated that "premature" was not necessarily the appropriate term since the agency has been in place for nearly 2 ½ years.

(For more on the legislation, use the search function in the upper left hand corner of this blog or click on the labels below.)

Correction

The item below incorrectly stated that SB771 would go to the Senate floor after clearing the Judiciary Committee. The bill actually goes to the Finance Committee and then to the floor, if approved by the committee.

Kuehl Legislation Up for Hearing This Afternoon

Legislation aimed ensuring a return on California's $3 billion stem cell research effort and affordable access to state-financed cures is scheduled to be heard this afternoon in a state Senate committee hearing that can viewed live on the Internet.

The measure by Sen. Sheila Kuehl, D-Santa Monica, is on the agenda of the Judiciary Committtee, its last stop before it could move to the Senate floor. The session begins at 1 p.m. PDT today. It can be seen on Calchannel.com. We recommend that you check in earlier to be sure your computer is properly configured to see the action.

The Foundation for Consumer and Taxpayers Rights Monday said the legislation is laudatory but falls short in guaranteeing affordable access to stem cell therapies funded by CIRM research. The measure is opposed by CIRM and the biotech industry.

The foundation said in a letter to legislators written by John M. Simpson, its stem cell project director:

"Foremost among the positive aspects, the bill clearly establishes that the Legislature has an appropriate role in oversight of the state’s stem cell institute, the California Institute for Regenerative Medicine. It requires intellectual property regulations that provide for a fair and reasonable financial return to the state on any discoveries made as a result of state financing. It also requires price discounts for drugs, therapies and diagnostics purchased with public money and that organizations receiving licenses provide reasonable access to therapies, drugs and diagnostics for uninsured Californians.

"However, SB 771 contains no provision ensuring that all Californians will gain affordable access to the results of the research they have funded. No one begrudges a company a reasonable profit. What must be prevented is egregious profiteering when public funds have been used to develop a therapy, drug or diagnostic.

"I wish this were only a hypothetical issue; it is not. Genentech’s lifesaving cancer drug Avastin was launched with the benefit of $44.6 million in public funding. Nonetheless, the company originally priced the drug at $100,000 for a year’s supply. Only after months of outrage has Genentec capped Avastin’s price at $55,000 a year.

"SB 771 needs a provision that would prevent this sort of abuse when public funds help produce important drugs and therapies. The Attorney General must have the power to intervene and reduce prices in similar cases."

Fresh Links and More

We have made a couple of modest changes on this Web site to help readers. They include links to background information on the California Stem Cell Report as well as its financial disclosure. Also added is a link to a short item telling how to search the blog more effectively. A link to the Americans for Stem Cell Therapies and Cures is now included, and the link to the Genetics Policy Institute has been fixed. If you have suggestions for additional links, please send them to djensen@californiastemcellreport.com.

The $222 Million Question and CIRM's Direction

The directors of the California stem cell agency will come to grips on May 2 with the abrupt departure of its president and a related acrimonious flap involving its plans to give away – or not give away -- $222 million for research laboratories.

The public will have a unique opportunity to hear and comment on those matters during the first-ever conference call meeting of CIRM's Oversight Committee. Locations are available in many areas of California where persons can listen to the session or make comments. Three in San Francisco, two each in La Jolla and Irvine and and one each in Los Angeles, Sacramento, Carlsbad , Stanford and Duarte. You can find the specific locations on the agenda.

The 29-member committee is scheduled to consider the appointment of an interim CIRM president, probably somebody from within the existing staff. It will also have to find a new chair for the Facilities Working Group.

The May 2 meeting was called after CIRM President Zach Hall moved up his departure date from CIRM two months following a contentious meeting of the Facilities group April 13. The chairman of that group also quit, resigning with no explanation.

Also on the agenda is the go-slow motion from the Facilities group on grants for major labs. The motion was unanimously adopted on April 13 by the Facilities group, which is dominated by patient advocate members of the Oversight Committee. The motion seemed to fly in the face of opposite direction from the full Oversight Committee just three days earlier. The Oversight Committee basically approved the schedule for the grants last year as well the dollars when it approved its strategic plan. However, votes can change.

Nominally nine patient advocates sit on the Oversight Committee but two also have significant ties to institutions that could benefit from lab grants. Fourteen Oversight members, including two patient advocates, have significant ties to institutions that could stand to benefit from lab grants. Here is the list of members.

CIRM's Facilities Meeting: 'Not So Terrible'

The contentious Friday the 13th session of the Facilities Working Group of the California stem cell agency triggers different reactions from different folks. We queried John M. Simpson, stem cell project director of the California Foundation for Taxpayer and Consumers Rights, about his impressions. Here is his reply.

"I've finally read the transcript of the FWG meeting. I actually didn't think it was so terrible.

"Yes, there were 'full,fair,frank exchanges of views' as the diplomats would say, but I thought the meeting got to what is a fundamental split on the question of how to award facilities grants-- or indeed if any should be awarded.

"I think all too often the academics and research institution representatives on the ICOC have exhibited almost a sense of entitlement to CIRM money.

"I am delighted to see members of the Facilities Working Group voicing their sense of responsibility to California taxpayers to be good stewards of CIRM funds. They are taking their responsibility seriously and should be commended for that.

"I'd also add that on the issue of making facilities grants, the academics are clearly conflicted.

"Deliberate speed is appropriate, but the emphasis must be on deliberate – not on speed for speed's sake."

Fresh Comments and Ariff Bongso

Lawrence Ebert, David Hamilton and Karl Bergman have all filed comments on the "Snippets" and "WARF News" items below. Some of them involve a story by Terri Somers of the San Diego Union-Tribune that we should have mentioned earlier. She wrote about how Ariff Bongso of the National University of Singapore in 1994 became the first scientist to derive human stem cells from an embryo.

Her story said:

"In the process, he laid the foundation for a field that many people hope will lead to new therapies for diseases such as diabetes, Parkinson's and cancer – and that others oppose because it destroys embryos.

"'Bongso made the connection between his area of expertise, human embryology, and stem cells, and just went for it' said Jeanne Loring, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla. 'That's how great scientific discoveries are made, for the sake of curiosity.'

"But Bongso never patented his work.

"For almost a decade, the fame and financial benefit of being the first to derive human embryonic stem cells has been heaped upon James Thomson and the University of Wisconsin."

CIRM Facilities Rancor: Delay and Dollars

Contentious, personal, confrontational, sarcastic – all could accurately describe last Friday's session of a key group of the California stem cell agency.

But, based on the transcript, the descriptions miss what was fundamentally important about the meeting and also what was hardly said. And that is: The agency is not required to spend $300 million on bricks and mortar – the major labs so desired by California research institutions. It is merely authorized to do so. And delaying them could mean more money for other endeavors.

The meeting of the Facilities Working Group was cited by CIRM President Zach Hall in his letter announcing that he was stepping down early. (See "Edifice" below.) The nominal topic of the meeting involved the laying more of the groundwork for $222 million in grants for major research facilities at California universities and nonprofit institutions.

But by the end of the acrimonious session, the Facilities Group, dominated by patient advocates, had set the stage for a major debate within the CIRM Oversight Committee. Three days prior to the Facilities meeting, patient advocates had lost a straw vote within the 29-member Oversight Committee for a more modest proposal for a written survey instead of the public hearings approved by the Facilities group. A seeming routine matter that was freighted with major baggage, including who is in charge – the Oversight Committee or its advisory groups?

Other issues emerged as well. The Facilities meeting highlighted the difficulties that any organization faces when it tries to operate without a "permanent" CEO. Hall was already a lame duck at the time of the meeting, having announced his departure last December. The session also demonstrated persistent divergence about the role of the CIRM president. Oversight Committee Chairman Robert Klein insisted that Hall execute the wishes of the Facilities Group even though Hall believed they conflicted with the Oversight Committee.

Finally, there were questions of the balance between making grants with great speed and exercizing due diligence.

Prop. 71, which altered the California Constitution and created CIRM, provided for spending as much as $300 million on laboratory facilities. If the agency does not spend all of the sum, the remainder could go for more direct development of cures and therapies, a high priority for patient advocates who sit on the board. At the same time, top executives from California universities sit on the Oversight Committee. Their view is that they do not have enough room for existing researchers, much less the ones that are being recruited to come to the Golden State to perform embryonic stem cell research financed by CIRM. Construction costs are spiraling upward, and any grants will buy less in 12 months than they do today.

Prolonging the grant process could, however, mean that more funds would be ultimately available for patient advocate-backed research. Unwilling to wait, institutions will find other funding sources. Needs will change. Grant criteria could become more strict, ruling out some institution's plan. Some projects may become prohibitively expensive because of rising construction and equipment costs.

No one on the Oversight Committee is talking publicly about such a delaying strategy but it is clearly viable. And it is one that is not likely to be regarded kindly by institutions represented on the panel.

At last Friday's meeting, Hall said that the Oversight Committee had indicated a need for speed in moving grants forward and that he was receiving the opposite instructions from the Facilities Group. He said his first responsibility was to the full Oversight Committee. Hall said,

"I feel it is very important that it be worked out at the highest governance level for this whole organization, which is the board. I think that is the key. This is a really important issue here, and there's a, I would even say, a cultural difference between those involved in the scientific culture who see the need, who understand the urgency, and who are trying to move this forward in order to get the whole project going, and those here whose point of view I have heard(at this meeting)."

Oversight Committee member Marcy Feit, CEO of Valley Healthcare Systems, said she did not detect the same urgency as Hall. She said,

"This is a public agency with taxpayer dollars. And we are foolhardy if we don't pay attention to our responsibility. But nowhere on that (April 10) board meeting did I hear any board member not encourage us to do our job. So I would beg to differ with you that there is a cultural difference. There is not a cultural difference. I think if there were the rest of the board members here today, they would agree with us."

James Harrison, CIRM's private counsel, said,

"Zach is correct, that the ICOC expressed its intent that gathering information through a survey or through some prenoticed letter was not necessary or desirable in light of the sense of urgency that was expressed."

Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group and author of the public hearings motion, said it would not mean a delay in approving grants. In response to a query, he said in an email,

"Will undertaking a deliberative approach cause a delay? No, it will not. The Facilities Working Group can do its thing and meet the deadline, but it will need the support of the president to make it happen. That's where things got a little tense (see item below)."

To resolve the $222 million worth of edifice issues plus the question of who will be in charge of CIRM beginning in May, the institute is attempting to set up a special meeting of the Oversight Committee as soon as possible. The meeting is likely to be in the form of a conference call.

The committee will be operating in an atmosphere damaged by the rancor of last Friday's Facilities meeting. For a closer look at the acrimony, see the item below.

A Friday Filled with Acrimony

"Time out. Time out," said Rusty Doms, chairman of CIRM's Facilities Working Group, at one point as the discussion threatened to wheel out of control.

It was a conference call meeting last Friday that CIRM President Zach Hall later cited as one reason for his early departure as head of the $3 billion institute. Dom also resigned, submitting a terse letter with no explanation.

On the agenda was the topic of how to give away $222 million for embryonic stem research facilities.

The contentious discussion went on for some length. Questions of responsibility, due diligence, consideration of the public interest, loss of purchasing power, conflicts of interest and more surfaced.

At one point, Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group, repeatedly demanded that Hall answer a question with a yes or no. It related to a motion, authored by Serrano-Sewell, for public hearings on research lab needs. The motion had just been unanimously approved by the group.

Hall said that the vote contradicted the position of the Oversight Committee three days earlier. This exchange followed, according to the transcript of the meeting:

Hall: "Now, given the unanimous vote of this working group, there is no – I think there's no point in us doing that(preparing an outline for a major facilities RFA for the June Oversight Committee meeting). It's very clear, but it's also very clear to me that there are two different points of view represented on the ICOC(Oversight Committee)."

Serrano-Sewell: "Zach, it's a simple question. yes or no? Before the June meeting, will you aid this working group in a hearing?"

Hall: "I will."

Serrano-Sewell: "Yes or no? Will you assist this working group?"

Hall: "I want direction from the ICOC about how we should proceed on this."

Serrano-Sewell: "I'll take that as a no. If you're not helping us before the June meeting by committing resources, saying, yes, working group, I will commit resources, I will commit time in aiding you setting up these hearings which you unanimously passed."

Hall: "I'm sorry."

Serrano-Sewell: "It's either a yes or a no."

At this point, Hall said it was a matter that needed to be worked out by the full Oversight Committee and reflected a cultural difference within that group.

More sharp exchanges can be found in the transcript. But care should be taken in the reading. It was a conference call situation. Tone of voice, facial expressions (where the participants were together) are all missing. And there may transcribing errors, which can occur because of the difficulty in hearing all participants.

One such error seems to involve a quote for Serrano-Sewell. In the transript, he is quoted as saying, "I wanted to create a constitutional crisis." We queried him about the remark. He said he recalled saying that he did NOT want to create a crisis.

CIRM Presidential Search: Semi-finalists in June

CIRM's presidential search committee met Tuesday only a few hours after President Zach Hall announced he was leaving early. Filling his vacancy has now become a more urgent matter.

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, monitored the conference call meeting. We asked him for his impressions. Here is what he sent.

CIRM is on a fast track to name the next president.

Tuesday's public session of the search committee meeting was short.

Lisa Piper (of the SpencerStuart search firm) gave an overview of the search process and said that SpencerStuart had gathered 450 names "using a variety of media including e-mail, phone and letters." There were also about 80 nominations.

From that pool SpencerStuart culled a "long list" of a dozen or so candidates that were to be discussed by the committee in the closed session. Plans were to cut that list to a short list of four to six candidates.

SpencerStuart would then interview and prepare reports on all on the short list for two-days of interviews by the search committee on May 11 and 12.

The plan is to select semi-finalists from the short list for presentation to the board for consideration at the June ICOC meeting.

I asked if Zach Hall's departure would have any impact on the time line. Most of the committee members did not seem to be aware of his early resignation.

Bob Klein responded by saying that CIRM had been run by an acting president and acting chief scientific officer when Zach was recently on vacation. The best course would be determined, he said, "in consultation with CIRM's senior staff to see what the proper solution would be."

"I am sure they will carry on in the tradition of excellence established by Dr. Hall," Klein said.

Wright: 'Not The Best Day'

More details emerged today on the heated, Friday the 13th session concerning the California stem cell agency's plans to give away $220 million for major research labs and buildings.

The meeting involved CIRM's Facilities Working Group, which is laying the groundwork for dispensing the funds (see the item below). At issue seemed to be questions of how much time and information was needed by members of the group before the grant applications went out. CIRM President Zach Hall characterized the meeting as "exceedingly contentious and personal" in a letter announcing his early resignation.

The session was not covered by the media, and a transcript is not yet available. So reporters prepared stories that were published today based on what some of the participants recalled in the wake of the resignation letter by Hall. That reconstruction process is common in the news business but always carries a certain amount of risk.

Reporter Terri Somers of the San Diego Union Tribune wrote:

"Dr. Janet Wright, a cardiologist who is a member of the (CIRM) board, said she couldn't believe the tone of contention, sarcasm and aggression toward Hall at the meeting.

"'I still don't know the gist of the attitude or tone, or where it was coming from,' Wright said. "I was so surprised by the tone, I couldn't seem to recover enough to call attention to it and try to set things right."

"Working group members David Serrano-Sewell and Jeff Sheehy acknowledged that they 'passionately' disagreed with Hall's stance at the meeting, but did not mean to be contentious or disrespectful.

"'I have nothing but the utmost respect for him. We couldn't have done all we've done without him,' said Serrano-Sewell, the working group's vice-chairman.

Somers continued:

"(A)t a meeting three days earlier, the full institute board had rejected a request by working group members, including (CIRM Chairman Robert) Klein, to survey possible grant recipients and others about their facilities proposals.

"As a result, Hall on Friday tried to push the working group to skip the information gathering and move directly to details of the grant applications....

"But the working group members voted unanimously for more information gathering, similar to the public hearing process that was used in developing the institute's standards and ethics policies and its strategic plan."

Carl Hall of the San Francisco Chronicle quoted Sheehy as saying:

"Zach identified a cultural divide that existed between the scientist members and the patient advocates, and he didn't want to straddle it anymore."

The stories also included the resignation of the chairman of the Facilities Working Group in the wake of the session. Rusty Doms, a Southern California developer, turned in a brief letter that did not cite any reasons for his departure. The letter was dated Sunday April 15, just prior to the announcement of Hall's resignation.

Jim Downing of The Sacramento Bee wrote:

"Bob Klein, the chair of the governing board, said Doms told him he was resigning principally because he did not have time to attend the series of meetings that Wright and others proposed. Doms is also on the board overseeing the construction of a major new hospital in Los Angeles, Klein said."

Somers said that one member of the public was uncomfortable with what occurred at the meeting, She wrote:

"'You can choose to agree or disagree, but the tone with which Zach Hall was treated was not the way you want to treat a president that accomplished so much for the (California Institute for Regenerative Medicine),' said Dan Oshiro, vice president of administrative affairs at the Gladstone Institute in San Francisco. The working group meeting was the first Oshiro had attended."

Downing of The Bee quoted Oversight Committee member Wright as saying,

"It was not our best day."

The $200 Million Edifice Issue

The resignation letter released earlier today by CIRM President Zach Hall referred to a more than $200 million edifice issue that now embroils California's stem cell agency.

What's at stake are huge grants for building projects at universities and nonprofit facilities throughout California. CIRM is currently involved in laying the groundwork for the grants, many of which will go to institutions whose leaders serve on the very board that will make the decisions about which receive money and which don't.

The key CIRM committee in preparing the criteria for the grants is its Facilities Working Group, which met last Friday. Hall's letter said the meeting was "exceedingly contentious and occasionally personal." He also said it was clear that there was a strong desire in the working group for a longer approach to the generating the grants than he was prepared to direct.

John M. Simpson, stem cell project director for the Foundation of Consumer and Taxpayer Rights, said in a press release that "Hall's health should be a primary concern, but clearly there are substantial disagreements at stake here. It's never a good sign when an agency's chief executive leaves after a policy dispute."

Hall declined to comment further on the remarks in his letter. The April 13 meeting was not covered by the media, and its transcript is not yet available. But based on responses from some Oversight Committee members at the meeting, it seemed to involve at least some of the issues that surfaced at a meeting of three days earlier at a meeting of the Oversight Committee.

The April 10 discussion was a bit unfocused and confusing. But it involved issues of whether additional information was needed before requests for grant applications could be prepared and what sort of building plans were underway at various institutions. Some Oversight Committee have pressed for continued speed in making grants. Others, in this case, said they needed more information.

Stem Cell Chairman Robert Klein called for a "straw vote" on whether CIRM staff should conduct a survey of California institutions about their stem cell related building plans. The transcript shows that the vote for a survey failed, but no actual vote was announced.

David Serrano-Sewell, an Oversight Committee member and vice chair of the Facilities Working Group, noted, however, that a majority of that group wanted the survey.

At about that point, Klein moved on to other issues before the Oversight Committee.

We queried some of the members of the Facilities group, which also includes persons who are not on the Oversight Committee, about Hall's remarks concerning the "exceedingly contentious" nature of the later Facilities meeting.

One said that Hall "got crosswise" with some of the patient advocate members at the Facilities group meeting.

Another member of the group said,

"There was some 'heated' adult conversation. Not contentious or personal, at most, it was passionate and spirited. I think the record, once published, will speak for itself. Zach did a lot of good and has alot to proud of."

The transcript will certainly help clarify what exactly transpired. But such documents also do not convey a complete picture of an event.

Hall clearly felt that what occurred was unusual and a cause for concern. It also comes at a time when much is at stake for medical school deans and others whose employers stand to benefit from the massive building grants. That is not to mention that the agency is in the midst of a search for a new president (Hall had already announced his intention to leave in June). Meanwhile the fledgling and tiny CIRM staff must continue to maintain a steady course without a permanent president and no indication when a new one might come aboard.

(On a personal note, Hall's health is the primary concern. We wish him a speedy recovery and all the best.)

Hall To Leave CIRM at End of This Month

In a surprise announcement, Zach Hall, president of the California stem cell agency, said he would leave his post at the end of this month instead of June. Among the reasons, he cited for his earlier departure is a recent diagnosis of prostate cancer.

Here is the full text of his resignation letter to the Oversight Committee:

"Dear Colleagues,

"I am writing to announce that I will be stepping down as President and Chief Scientific Officer of CIRM as of April 30. I had originally intended to stay through the June ICOC meeting, but several recent developments have caused me to change my plans.

"First, and most importantly, I have recently been diagnosed with prostate cancer and, in early May, will be undergoing surgery that will require several weeks convalescence.

"Secondly, I had hoped, in spite of the surgery, to stay long enough to complete the Shared Laboratories RFA review and to help launch the large facilities RFA in June. It is clear from the most recent Facilities Working Group meeting, however, that there is a strong and understandable desire by the working group to have a longer and more deliberative approach to developing the RFA than I will have time to lead. In addition, the exceedingly contentious and occasionally personal tone of the last FWG meeting suggests that it is in both my best interest and that of the Institute for me to step down at this time.

"I am very, very proud of what we have accomplished together. I have enjoyed working with such a distinguished and talented group, both on the ICOC and at CIRM. It has been a privilege to participate in this great project, and I wish you every possible success as you continue to pursue it."

WARF News and a California, Scientific Perspective

The WARF stem cell fracas has received more attention in the past few days – primarily in Wisconsin where the University of Wisconsin could miss out on millions if its benefactor – WARF – loses its patent fight.

Reporter David Wahlberg of the Wisconsin State Journal reviewed the history of WARF and the stakes involved in a piece that noted Vitamin D is the big revenue producer for WARF. Stem cells come in eighth, less than one percent of WARF revenue. Currently WARF, which sprang to life 82 years ago to promote a method of increasing the vitamin D content of food, pumps $60 million annually into UW.

The patent battle had its roots in California, with John M. Simpson of the Foundation for Taxpayer and Consumers Rights and Jeanne Loring of the Burnham Institute collaborating with the Public Patent Foundation to challenge WARF's stem cell patents.

Simpson and Loring both had op-ed pieces in Wisconsin newspapers during the past week. Simpson wrote on April 11 in the Milwaukee Journal Sentinel. Simpson said that Wisconsin would not lose its stem cell luster even if WARF loses the patent fight.

"Wisconsin will remain a leader in the field because of (James) Thomson and his colleagues' work, and research firms will continue to locate near UW because of the proximity to its vibrant scientific community.

"But officials from a self-serving foundation with its own narrow agenda cannot be allowed to elbow their way to the table by waving undeserved patents that are ultimately detrimental to researchers everywhere."

In a similar piece in the Wisconsin State Journal, Loring wrote:

"Wisconsin’s leadership in stem cell research has nothing to do with these patents. It has everything to do with the admirable talent and dedication of Wisconsin scientists who devote their lives to this work.

"WARF’s executives are understandably unhappy about the patent office’s decision because they think they will lose money. But they could save an enormous amount of money, and gain a great deal of good will, by quietly dropping their claims to human embryonic stem cells and allowing the judgment of the patent office to stand. If they did this, they could be seen as a supporter, not an exploiter, of scientific research."

Finally on the Wisconsin Technology Network, Grady Frenchik and Michael J. Cronin, two Wisconsin attorneys, authored a Q&A on the patent challenge process and possible outcomes.

Stem Cell Snippets: J&J, Novocell, Geron and Cha

Big Pharma and ESC – David Hamilton has pulled together some little noticed information on Johnson & Johnson's investment in Novocell of San Diego, Ca.. "For what appears to the first time, a major drug company has plunked down a significant equity investment in embryonic stem cells," he wrote on VentureBeat. He continued, "If J&J’s investment is a sign that regenerative medicine is quickening pulses in at the big drug companies, things could get interesting. Unfortunately, that’s mostly just speculation at this point."

Stem Cell Perceptions – Greg Pesto, writing on Market Watch, reflected on public and investor perceptions in the wake of the stem cell debate in Washington. He quoted Tom Okarma, CEO of Geron, as saying, "We have given up on actively trying to change the politics. We have our heads down trying to the science." The California firm hopes to begin a clinical trial using embryonic stem cells later this year.

Cha – William Heisel of the Los Angeles Times has the latest on the manuvering in the Cha plagiarism case, including the Korean researcher's legal and public relations campaign. The Times also reported that the publications committee of the American Society of Reproductive Medicine met on Friday without coming to a public decision in the case.

Kuehl's CIRM Bill Advances on 9-0 Vote

Despite opposition from the California stem cell agency, a state Senate committee Wednesday approved legislation aimed at ensuring that the state receives both an economic and health-related return on its $3 billion stem cell research effort.

CIRM opposed the measure – SB771 – on the grounds that it was premature. However, the Health Committee sent the legislation to the Senate Judiciary Committee on 9-0 vote. If it wins approval there, it will move on to the Senate floor, where it requires a whopping 70 percent vote for approval. That extraordinary requirement was dictated by Prop. 71. It was written into the initiative so that CIRM could operate virtually untouched by normal legislative and gubernatorial controls.

From our perch here in Mexico, we could not connect with the live Webcast of the proceedings. But we have been told that several senators pointed out to CIRM officials that they (the legislators) represent the public interest.

Lawmakers also did not see any barriers to advancing the legislation while CIRM, which is nearly three years old, continues to wrestle with its intellectual property rules, which the bill addresses. They asked CIRM to identify specific problems with the bill instead of arguing that it is premature.

Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee and author of the bill, said she would work with CIRM to develop IP policies that make sense and protect the public interest.

She also pledged to develop methods to handle unique situations such as orphan drugs, for which there may not be as much room to demand revenues and pricing concessions.

As far as we can tell, no other news outlets have published stories on the Health Committee action.

CIRM Firm Against Kuehl Legislation

The Oversight Committee of the California stem cell agency Tuesday voted unanimously to oppose legislation aimed at ensuring that California shares the benefits of any therapies developed with $3 billion in state-funded research.

Reporter Terri Somers of the San Diego Union-Tribune wrote that the board considered the legislation "premature."

She quoted Dale Carlson, chief communications officer for CIRM, as saying the agency, which has been in existence for more than two years, should be given time to complete its policy-making process.

According to Somers, Carlson said,

"The board members appreciate that Senator Kuehl has an interest in fair prices, fair access and fair returns to the state. Those are our objectives as well. We'd like the opportunity to continue to work with her and other members of the Legislature to come up with a mechanism that best achieves those objectives."

Sheila Kuehl, D-Santa Monica, and state Senate Republican leader George Runner of Antelope Valley are co-authors of the bill, SB771, which comes before Kuehl's Health Committee this afternoon. The session will be broadcast live on the CalChannel.

Also now available online is the Health Committee staff analysis of the measure, which explains the bill in straightforward terms.

Somers, by the way, appears to be the only reporter in California who wrote a story based on Tuesday's Oversight Committee meeting.

Stem Cell Snippets: Labs, Cha and Pomeroy

Wasteful Lab Duplication – Reporter Nicole Gaouette of the Los Angeles Times wrote about how George Bush's stem cell funding edict has resulted in wasteful efforts in stem cell research. The article indirectly raises a question about how much money NIH spends chasing down possible violations of the ambiguous and dubious directive. Gaouette uses examples from UC San Francisco and Advanced Cell Technology in Alameda, Ca.

Cash for Large Stem Cell Facilities – Reporter Terri Somers of the San Diego Union-Tribune reported that CIRM hopes to have $225 million available for large stem cell research labs. Applications could be ready this summer. Recipients would have match at least 20 percent of the grant, according to the initial proposal.

CHA – The Scientist magazine has the latest on the Cha affair with a statement from Alan DeCherney that the publications committee of the American Society for Reproductive Medicine will meet Friday to discuss the matter. Also now available onine is the full text of the British Medical Journal article concerning the case.

Pomeroy – Claire Pomeroy, a member of the CIRM Oversight Committee and dean of the UC Davis School of Medicine, discusses stem cell issues in the Sacramento News and Review. Among other things, she worries about stem cell tourism – the practice of folks seeking stem cell therapies abroad. In many cases, inadequate oversight exists. She also reviews the status of stem cell research at the UC Davis campus. The Cal Aggie campus newspaper also carried a piece on a presentation to the Oversight Committee Tuesday on vascular disease research.

CIRM Litigation – The folks seeking to put CIRM out of business have filed with the State Supreme Court their request to overturn two earlier decisions against them. The court has until June 5 to make its decision.

State of Affairs – Reporter David Louie broadcast a piece on San Francisco TV station KGO on April 10 that reviewed the stem state of affairs in California. He said that thanks to CIRM, the state is
"is already well on the way to making its own breakthroughs in stem cell research."

Live Internet Broadcast of CIRM IP Legislation

One advantage that the Big Tomato, as Sacramento is sometimes known, has over other cities in California is that seems a little better wired in terms of bringing state government information to users of the Internet.

For example, you can hear remarks by California stem cell Chairman Robert Klein to the Sacramento Press Club on Monday on the Press Club's web site. A video is promised as well on the CalChannel website.

For your planning purposes, Wednesday's hearing of the Senate Health Committee on SB771 will be broadcast live on CalChannel. If you want to view it, you might tune in early to one of the other broadcasts to be sure your computer is properly configured for playing the live video.