Friday, April 27, 2007

Hoisting Anchor

The California Stem Cell Report will be on a hiatus beginning Saturday morning. As many of you know, this effort is produced primarily from a sailboat on the west coast of Mexico. We are putting out to sea and will not have access to the Internet – only clear water, hopefully reasonably calm seas and pleasant temperatures – for the next few weeks. Look for resumption of operations sometime after the middle of May. The break also means that comments submitted to the blog, which are moderated, will not be posted while we are wandering about the briny deep. Sphere: Related Content

More Fallout from CIRM's Facilities Meeting

The Friday the 13 meeting of the CIRM Facilities group generated additional coverage in the last few days. That was the meeting that precipitated the early departure of the president of the California stem cell agency. The chair of the Facilities group also resigned without explanation following the session.

On May 2, CIRM's Oversight Committee will meet to deal with the fallout.

Science
magazine described CIRM President Zach Hall as "rattled " by the Facilities session. The account was based on the transcript of the meeting. Our reading of the transcript, plus knowledge of the cast of characters involved, does not support that characterization. Some who were actually present also do not agree with the description. Today, by the way, was Hall's last day at CIRM.

The San Jose Business Journal wrote about how the lack of lab space is delaying the development of cures based on embryonic stem cell research. We have not seen the entire piece, but this is a message that will be delivered with some emphasis next week at the Oversight Committee meeting. You may recall that patient advocates are taking a go-slower tack on funding research labs. Sphere: Related Content

Fresh Link

We have added a link to a site operated by Ben Kaplan called Ben's Stem Cell News: All The Latest Stem Cell Research and Science News. Ben and his brother were featured in the "Twins" TV ad for Prop. 71, which can be seen on YouTube. Kaplan reports they recently shot another stem cell video for Current TV which is expected to be aired soon. Sphere: Related Content

Coverage on the Cha Retraction

The latest doings in the Cha affair were reported today in the Los Angeles Times and The Scientist magazine, following the report on this site yesterday that the article in question was being retracted by the journal that published it.

William Heisel of the Times began his story by saying:
"A U.S. medical journal will retract an article that set off an international plagiarism dispute but will take no action against the lead author, a prominent South Korean scientist whose Los Angeles institute is in line to receive state funds for stem cell research."
Alison McCook of The Scientist had a similar story but with less detail. Sphere: Related Content

Thursday, April 26, 2007

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. Sphere: Related Content

Tuesday, April 24, 2007

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.) Sphere: Related Content

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. Sphere: Related Content

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."
Sphere: Related Content

Monday, April 23, 2007

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. Sphere: Related Content

Sunday, April 22, 2007

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. Sphere: Related Content

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."
Sphere: Related Content

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."
Sphere: Related Content

Thursday, April 19, 2007

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. Sphere: Related Content

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. Sphere: Related Content

Wednesday, April 18, 2007

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.
Sphere: Related Content

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."
Sphere: Related Content

Tuesday, April 17, 2007

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.) Sphere: Related Content

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."
Sphere: Related Content

Sunday, April 15, 2007

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. Sphere: Related Content

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

Big Pharma and ESCDavid 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 PerceptionsGreg 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.

ChaWilliam 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. Sphere: Related Content

Thursday, April 12, 2007

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. Sphere: Related Content

Wednesday, April 11, 2007

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. Sphere: Related Content

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.

CHAThe 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.

PomeroyClaire 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." Sphere: Related Content

Tuesday, April 10, 2007

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. Sphere: Related Content

Minimal Stem Cell Coverage in Sacramento

News coverage of an appearance by California stem cell chairman Robert Klein in Sacramento was light today with perhaps the most interesting piece appearing on a local television station.

Reporter Kevin Riggs broke little new ground for readers of this blog, but he probably brought important information to viewers of television station KCRA, one of the major players in the Sacramento TV market.

TV stations rarely cover the stem cell agency in California. At the same time, most people get their news from the electronic media – not newspapers. So the perspective and images from the rare TV stories are significant in assessing how the public perceives CIRM.

In this case, Riggs' report was generally favorable with strong images of scientists doing work in labs at UC Davis. He had an interview with Klein, who deplored the legal efforts by opponents to stymie the agency. Riggs also had an interview with an opponent of the agency who complained about conflicts of interest. You can find a partial text of the story here, but to really understand what was said and see the visuals, click on the adjacent video.

Jim Downing of The Sacramento Bee also wrote about Klein's appearance in a story that focused on the stem cell debate in Washington, D.C.

As far as we can tell, those were the only two stories out of Klein's appearance Monday. Nothing appeared concerning the CIRM hearing on IP Monday afternoon, based on an Internet search. Sphere: Related Content

Sacramento Bee: Curb Klein's 'Political Adventures'

"Nagging problems" persist at the California stem cell agency, including "political adventures" by its chairman, Robert Klein, The Sacramento Bee said today.

In an editorial, The Bee said that in addition to Klein's dabbling in politics, the problems include efforts by the biotech industry to weaken CIRM rules to generate revenue and affordable care and failure to disclose the economic interests of scientists who review applications for hundreds of millions of dollars in grants.

The Bee had some good things to say as well. CIRM is now "the nation's largest financier of embryonic stem cell research," which is what voters approved in 2004, newspaper said.

In its "memo" to CIRM, The Bee said:
"You've also hired a fine scientific staff to help administer grants and design a strategic plan. These employees will help your institute transition to new leadership, since President Zach Hall will be retiring in June and you are currently interviewing for his replacement."
But the newspaper said,
"Your board chairman, Robert Klein, continues to dabble in political adventures that don't comport with his responsibilities as a public official. Last year, he used a nonprofit organization to campaign against state Sen. Deborah Ortiz in her bid for secretary of state, after Ortiz had sought reforms in the stem cell institute. Klein's nonprofit also took sides in the lieutenant governor race. Rarely have we seen the head of a state agency create his own separate political apparatus to punish enemies and reward friends. These tactics have hurt the institute's standing and you need to put an end to them."
The editorial also said:
"So far, you've resisted public disclosure, claiming it could scare away qualified reviewers. Yet researchers make such disclosures all the time. As one of your reviewers, Rainer Storb, told The Scientist last year, such disclosures "are a bit of a nuisance. But I'm perfectly fine with things being made public."
Sphere: Related Content

Monday, April 09, 2007

Sacramento's Stem Cell Topic of The Week: Sharing the Swag

You could call it Stem Cell Week in the Big Tomato, as Sacramento is sometimes known. Today begins a round of events in the capital city linked closely to the California stem cell agency and the dreaded topic of intellectual property, which really is a simple question of who wins and who loses.

California stem cell Chairman Robert Klein speaks today at a luncheon meeting of Sacramento Press Club, followed by a CIRM hearing this afternoon on IP issues. Tomorrow the institute's Oversight Committee holds a meeting in Sacramento. And on Wednesday, the Senate Health Committee takes up SB771, legislation by Sen. Sheila Kuehl, D-Santa Monica, aimed at ensuring a return to the state on products developed as a result of the state-funded research. Her bill is also aimed at providing affordable access to stem cell therapies. (For more background see "White Knights.")

We have already seen opposition to the measure from California's biotech industry. But three other groups have announced support or at least partial support.

Donna Gerber, governmental relations director of the California Nurses Association, sent an endorsement letter to Kuehl, which said,
"Without the changes proposed by SB771, Prop. 71 has the potential to become a direct giveaway of three to six billion dollars in public funds to large biotech and pharmaceutical corporations that stand to make enormous sums of profits off the public through.

"Current regulations do not ensure that uninsured residents, who have few resources to pay for expensive stem cell treatments, will be able to access those therapies when they become available. They also restrict the ability of the publicly funded programs to get discounts on stem cell therapies the state has helped pay to develop. Similarly, the regulations propose to cap the state's share of revenues from products developed with Prop. 71 funds, instead of allowing the state to receive a return commensurate with its contribution to the research.

"SB771 will ensure that the state benefits from its $3 billion investment in stem cell research by requiring research grantees and licensees to share revenues from the stem cell therapies that the state has paid to help develop and provide discounts on stem cell drugs."
Marcy Darnovsky, associate executive director of the Center for Genetics and Society, wrote,
"This bill would ensure that the state receives a fair return from any profitable discoveries made with publicly-funded stem cell research while improving access by economically vulnerable Californians. But we are concerned that the bill as currently written does not go far enough to protect Californians from potentially unfair pricing practices.

"However, we are concerned that potentially unfair pricing practices could harm Californians. If faced with excessively high prices for drugs or treatments, insurers would likely either pass the costs on to patients or fail to cover them. No one wants to see medical treatments developed with public funds be inaccessible to middle-class Californians who have medical insurance. We would like to see SB 771 amended to provide a specific mechanism or procedure with which the state can act to prevent excessive pricing of inventions developed with public funding."
A third group, the California Alliance for Consumer Protection, endorsed the measure, declaring it will help ensure that there will be continuing funds for stem cell research, among other reasons.

(Editor's note: Sacramento is known as the Big Tomato because of the thousands of acres of tomatoes that are grown in the vicinity. Decades ago, the Sacramento River used to run red with waste from tomato processors during the summer.) Sphere: Related Content

Fresh Comments, No. 1, April 9, 2007

JeongHwan Kim, the researcher whose work was allegedly plagiarized in the Cha matter, has responded in a comment on the "Harvard's Kim Responds" item below. Lawrence Ebert has also posted commentary on the same item. Sphere: Related Content

Sunday, April 08, 2007

Editor's Advisory on Recent Cha Items

If you haven't checked this blog since late Friday, a lot of fresh information has been posted on the Cha matter. We recommend that you begin with the "British Medical Journal" item. That will establish the framework for the additional material, which is largely original source stuff from some of the folks involved. Lawrence Ebert has commented widely on the material as well on his blog – Ipbiz. Sphere: Related Content

Fresh Comments

Lawrence Ebert has posted fresh comments on the "Lee Letter" and "Baristas" items below. Ebert has written at more length on what he calls "Cha-gate" on his blog – Ipbiz. See "CIRM grant" and "Fulminations." Ebert also links to the article in The Scientist on the plagiarism issue, which also has additional commentary from readers, including Sook-Hwan Lee's letter. Sphere: Related Content

Harvard's Kim Responds on the Cha Matter

Following publication of the British Medical Journal item below, we queried one of those mentioned, Kwang-Soo Kim, whether he had anything further to say on the matter. He forwarded the following via Tony Knight of Sitrick and Company, a public relations firm.

"After learning about this incident, I was quite frustrated and concerned
with the situation and, thus, personally investigated the matter by carefully discussing the details with each of the authors of the paper. My conclusion is that this is a most unfortunate situation stemming from a disgruntled junior scientist's unprofessional conduct which appears to have been unnecessarily amplified by an all-too-eager reporter who was either misinformed or is not properly reporting all the facts of the case.

"However, we are hopeful that with the disclosure and consideration of all the facts involved, a fair outcome will result not only in the pending legal proceeding but also with Fertility and Sterility.

"As a fellow research scientist with more than 23 years of research experience in the U.S., as well as knowledge of the scientific community in Korea, I feel some background information may prove to be helpful and insightful regarding the dual- publication issue.

"I personally have very strong objections to this practice where the dual publication in a non-SCI Korean journal and an SCI journal were pursued. I do not know for certain how widespread this practice has been in recent years. But I am pleased that it was halted in 2006 with the publication of a new guideline by Korean scientific leaders.

"Given that the practice of publishing in both a non-SCI domestic journal and a SCI international journal was accepted by some in Korean, it is somewhat understandable that Dr. Lee followed this practice, although I think it was a terrible mistake. All the other authors were not even aware of the fact that this paper was previously published in a Korean journal and, thus, are innocent.

"We at Pochon CHA University believe the matter should be corrected, and Dr. Lee is planning to retract the first paper from the Korean journal. The paper's scientific integrity is without question and it should remain in F&S.

"Based on my conversations with all of the other authors, I believe that Dr. Kim's contribution was marginal compared to the research project in total. Authorship of a scientific paper is based less on who drafted the text than on who performed the scientific work and whose original idea and investigative thought went into the research. In particular, in this type of genetic studies, it is crucial how the samples are organized and collected, including both patient and control samples. Dr. Kim deserves authorship because of his partial but direct contribution, and Dr. Lee did credit him as an author in her submission of the manuscript to F&S.

"Needless to say, the data and results produced from a lab are attributable to the principal investigator and the rightful, proprietary property of the sponsoring institution. The fact of the matter is that Dr. Lee was the principal investigator and director of the lab and all of the resulting data was attributable to Dr. Lee and the rightful property of CHA Hospital. It is also a fact that Dr. Kim took this data without anyone's knowledge or proper permission which was a huge violation of trust with Dr. Lee, the other researchers and the entire organization, as well as a serious breach of company policy and that of the implicit rule regarding research data and intellectual property within every research lab. I believe this is why he did not leave any contact information and could not be reached."
Sphere: Related Content

Friday, April 06, 2007

Text of CHA Response to a Variety of Issues

The three following items were provided today by a representative of CHA in response to queries by the California Stem Cell Report. One is a letter to the editor of the Los Angeles Times, which has not been published as of the date of this writing. The other was sent to The Scientist magazine and is posted on their web site. The final document is information prepared in connection with the grant by the California stem cell agency to CHA RMI.

All of the items are posted verbatim as received from Tony Knight of Sitrick and Company, a Los Angeles "strategic communications" firm. Sphere: Related Content

Cha Letter to Los Angeles Times

Text of letter to Los Angeles Times

Letters to the Editor

Los Angeles Times
202 W 1st Street
Los Angeles, CA 90012

Fax- 213-237-7679
letters@latimes.com

Dear Editor:

Your stories, “Stem cell grant OKd for L.A. center linked to allegations” (March 26) and “Credit for U.S. journal article at issue” (February 18), inaccurately portrayed the controversy over an article in the journal Fertility & Sterility as a “plagiarism dispute.”

As the one who originated the idea for the project and provided guidance and oversight for the collection of the patient samples, I was entitled under the relevant rules to a “first author” credit.

Dr. Jeong-Hwan Kim says he should have been listed as an author. In fact, Dr. Sook-Hwan Lee’s Feb. 5, 2005 letter to F&S, enclosing the manuscript, credited Dr. Kim with “clinicopathological analysis and statistical analysis." Even so, the sample data collection work had begun well before Dr. Kim became involved.

Dr. Kim’s name was dropped when he left Korea and he could not be found to sign the paperwork required by F&S. When Dr. Kim was located in 2006, Dr. Lee wrote letters to F&S asking his inclusion as an author.

The research was done at the Human Genetics Laboratory of CHA Hospital, where Dr. Lee was the director. Lab documentation shows that Dr. Kim’s contribution to the actual research was marginal. He collected two of the 30 patient samples, and none of the control samples. Other CHA doctors and laboratory scientists collected the other specimens and accomplished all DNA extraction. Dr. Kim compiled the basic statistics
and wrote the thesis in Korean.

As Dr. Lee informed The Times, Dr. Kim submitted the paper in Korean to the Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without her knowledge or consent. She translated the article into English for F&S, and she was the only author who knew of the prior KSOG publication.

None of the other authors, including myself, were aware of the article’s prior publication. Dr. Lee was correctly listed as an author on both papers, so plagiarism is also out of the question with regard to Dr. Lee.

Finally, your article said I had improperly used M.D. after my name on web sites of U.S. clinics and laboratories that are part of the CHA family of institutions. The web sites that refer to me are aimed at an international audience. I am the Chancellor of the College of Medicine at Pochon CHA University, a trained physician, licensed to practice medicine in Korea. I do not practice medicine in California and have never held myself out as a physician practicing in California.

Regards,

Kwang Yul Cha, M.D.
Chancellor
Pochon CHA University College of Medicine
Sphere: Related Content

Lee Letter to The Scientist

Text of letter to The Scientist

March 22, 2007

Richard Gallagher
Editor
The Scientist

Dear Editor:

Your February 20 article “Fertility journal censures scientists” contained inaccuracies and omitted important facts regarding a paper by myself and my colleagues in the journal Fertility & Sterility titled The Quantitative Analysis of Mitochondrial DNA Copy Number in Premature Ovarian Failure Patients Using the Real-Time Polymerase Chain Reaction (2005).

It is not true that Dr. Jeong Hwan Kim “performed the bulk of the research,” nor is it true the paper was submitted to F&S without Dr. Kim listed as an author. As of this writing, F&S has not censured me or any other authors. And Dr. DeCherney’s comment that all of the authors of the paper “perjured themselves” is baseless, as I will explain below.

The concept for this research originated with Dr. Kwang-Yul Cha in 1998. Dr. Cha and I designed and wrote the research proposal in 2001. Korea’s Ministry of Health and Welfare funded the research. My intent from the beginning was to seek publication in an SCI journal.

Most of the research was accomplished by myself and other researchers in the Human Genetics Laboratory of CHA Hospital. Dr. Kim became involved in 2002 when he asked for my guidance on his doctorate thesis and joined us as a part-time researcher.

I am told that he claims to have collected all 30 of the POF patient samples. We have documented proof he collected only two patients’ samples, and he collected no control samples. Other CHA Hospital doctors collected most specimens, and other scientists at the Human Genetics Laboratory accomplished all DNA extraction, prerequisite for real-time PCR. Dr. Kim compiled the basic statistics and wrote the thesis in Korean.

I agreed to help Dr. Kim with his doctoral thesis and permit him to participate in the research on the condition that any resulting paper would be submitted to an SCI journal. Upon receiving his degree from another institution, however, Dr. Kim submitted the thesis in Korean to the non-SCI Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without my knowledge or consent.

He also took all of our data without authorization and moved out of Korea leaving no forwarding address. I subsequently filed a legal complaint against Dr. Kim that is being investigated by the Korean Public Prosecutors Office.

Unable to locate Dr. Kim, KSOG recognized my name among the authors listed and contacted me. This was the first I was aware the paper had been submitted to KSOG.

Perhaps I should not have done so for my student, but I agreed to be the corresponding author when KSOG could not find Dr. Kim. (I am told that Dr. Kim says locating him would have been easy, but KSOG was unable to find him. More recently, an official Korean Public Prosecutors Office document stated that his whereabouts were “unverifiable.”)

The loss of our original data deprived me of an ability to write a second paper, yet I remained committed to submitting the research to an SCI publication. I translated the KSOG paper into English and submitted it to F&S with myself as the corresponding author.

Dr. Cha was listed as the first author on the F&S article because he originated the idea for the project and provided guidance and oversight for the collection of the patient samples. He was entitled under the relevant rules to “first author” credit.

Dr. Kim was included as an author on the original submission to F&S. My Feb. 5, 2005 letter to the editor of F&S, enclosing the manuscript, credited him with "clinicopathologica1 analysis and statistical analysis."

But Dr. Kim could not be found to sign paperwork required by F&S. His name was dropped for this reason only. When Dr Kim surfaced in 2006, I wrote two letters to F&S requesting his inclusion as an author. F&S never replied.

The paperwork F&S required the authors to sign was related to “financial” conflict of interests, not prior publication. None of the other authors, except myself, knew that the article had been published in KSOG. Hence, Dr. DeCherney’s ‘perjury’ allegation against the authors is without merit.

I express my sincere regret for the controversy and assume full responsibility as the corresponding author of the paper. No one else is to blame. No harm, sanctions or reputational damage should be directed to my co-authors.

I ask that you publish this letter in full in order to set the record straight.

Sincerely,

Sook-Hwan Lee, M.D., Ph.D
Sphere: Related Content

CHA RMI Statement on CIRM Grant

Text of the CHA RMI Statement:

March 24, 2007

Statement CHA Regenerative Medicine Institute

CHA Regenerative Medicine Institute is a non-profit organization
incorporated in California on Dec. 21, 2005 and has been engaged in
adult and embryonic stem cell research at its Los Angeles laboratory.

CHA RMI's mission is to develop regenerative cell and gene therapies for
the treatment and cure of human diseases. CHA RMI focuses its research
on advancing therapeutic cloning technology to create patient-specific
stem cells using fresh and frozen human eggs.

CHA RMI is able to bring to California patented vitrification technology
first developed at CHA BIOTECH and other advanced proprietary stem cell
technologies, which would otherwise not be available in the state,
because of its association with CHA Stem Cell Institute. All of CHA
RMI's facilities and research staff are located in California and all of
its work will be done in the state.

CHA RMI's research scientists are presently focused on:
* Production of embryonic stem cell lines from somatic cell
nuclear transfer- embryos
* Establishment of embryonic stem cells from donated eggs
* Differentiation of embryonic stem cells into specific cell
types.
* Investigation of adult stem cells for diabetes

CHA RMI's articles of incorporation state that it is organized under the
Nonprofit Public Benefit Law for charitable purposes and is not
organized for the private gain of any person. The articles further state
that the property of this corporation is irrevocably dedicated to
charitable purposes and no part of the net income or assets of this
corporation shall every inure to the benefit of any director, officer or
member thereof or to the benefit of any private person.

CHA RMI is associated with CHA BIOTECH, a leading stem cell research
institute in Korea, established in September 2000 by Pochon CHA
University College of Medicine and CHA General Hospital Group in order
to create a central, multidisciplinary research facility where the
university's scientists and hospital physicians could come together and
focus their efforts on developing stem cell, gene therapy and
regenerative medicine technology.

CHA BIOTECH, however, does not have any ownership interest in CHA RMI
nor does it have any voting rights on the Board. None of the member
companies belonging to CHA Health Systems have any ownership interest in
CHA RMI and none of the companies have any voting rights on CHA RMI's
Board.

Dr. Kwang Yul Cha, Chancellor of Pochon CHA University College of
Medicine, was listed as the initial chief executive and a member of the
Board of CHA RMI during the time when the non-profit laboratory was
being established. He has since resigned from these positions according
to the reorganization plan that was intended from the inception of the
institute. Dr. Cha does not hold any administrative or managerial title
at CHA RMI.

Dr. Cha is an internationally known fertility specialist with more than
100 articles published in peer-reviewed scientific journals. He received
his medical degree from Yonsei University in Seoul, Korea, and performed
his postdoctoral fellowship in endocrinology and infertility at the
University of Southern California. He also served as a visiting
professor at Columbia University

Dr. Cha succeeded with Korea's first Gamete Intra Fallopian Transfer,
Asia's first pregnancy in a woman without ovaries and the world's first
pregnancy from in vitro culture of immature oocytes collected from
unstimulated ovaries.

His research has received awards from the American Society for
Reproductive Medicine and the International Federation of Fertility
Societies. His research accomplishments have been featured in stories by
Time magazine, The New York Times and The Wall Street Journal.

Since its establishment in December 2005, CHA RMI has received approval
from the Western Institutional Review Board (WIRB) to conduct embryonic
stem cell research using frozen human eggs. This approval makes CHA RMI
the first research institute in the world to receive permission to
conduct stem cell research using frozen human eggs.

On March 16th, 2007, CHA RMI was awarded a $2,556,066 grant from the
California Institute for Regenerative Medicine (CIRM) to conduct
research in the "Establishment Of Stem Cell Lines From Somatic Cell
Nuclear Transfer-Embryos in Humans." The purpose of the research is to
provide a novel resource to the biomedical research community to study
and understand how genes correlate with the development of diseases such
as Amyotrophic Lateral Scelerosis (ALS), also known as Lou Gehrig's
disease.

CIRM's President and Chief Scientific Officer Zach W. Hall, Ph.D.,
stated: "These grants provide substantial support to a pool of very
distinguished researchers in human embryonic stem cell research." He
added that because of the size of the grants, "Our reviewers had higher
expectations and more rigorous standards for judging this set of
applications."

In its review of the "impact and significance" of the proposed research,
CIRM wrote: "As no ALS embryonic stem cells are currently available, the
isolation and characterization of such a diseased line will not only
provide the beginning of a proof of concept for this technology, but
more importantly will establish a realistic platform to study the
molecular basis of ALS, a devastating disease which remains incurable.
The other main significance of this work is the use of frozen oocytes
instead of fresh oocytes, which alleviates a number of ethical issues
regarding payments for donations to patients. This should not be
underestimated, as this simple fact is one of the major limitations of
SCNT approaches."

The principal investigator of the CIRM sponsored research is Jang-Won
Lee, Ph.D., who received his doctoral degree in animal science from the
University of Connecticut. Dr. Lee had been a research fellow at Wake
Forest Institute Regenerative Medicine, Winston Salem, NC and at
Children's Hospital & Harvard Medical School, Boston, MA. Before
assuming his post at CHA RMI, Dr. Lee holds an assistant professor
position at Pochon CHA University College of Medicine.

A full copy of the CIRM review can be found at:
http://www.cirm.ca.gov/publicsummaries/RFA_06-02/summary/RC1-00123-1.htm
l
Sphere: Related Content

British Medical Journal Discloses More Details in Cha Matter

The British Medical Journal has taken up the matter of Kwang Yul Cha and allegations of plagiarism against him, an issue that has raised concerns from two stem cell watch dog groups in California.

The four-page article in the April 7 issue of BMJ begins like this:
"A bitter dispute over the authorship of a twice published medical paper has pitted a 35 year-old Korean doctor against one of the most powerful players in the country’s struggle for biotech supremacy. The battle is threatening to disrupt Korea’s efforts to recover scientific credibility in the wake of the recent scandal over Woo-Sok Hwang’s stem cell research."
Cha is of special interest in California because the state's stem cell agency last month approved a $2.6 million research grant to a non-profit subsidiary, CHA RMI, of the CHA Health Systems organization, which is headed by Cha. The Oversight Committee of the California stem cell agency approved the grant with little discussion and no public notice prior to approval that it was for CHI RMI. CIRM's standard practice is to withhold the names of grant applicants. Following public disclosure six days later of the linkage between CHA RMI and Cha, two watchdog groups raised questions about grant.

The BMJ article was written by Jonathan Gornall, who added details and new information to what already has been reported concerning Cha. Gornall wrote:
"Now, as the dispute escalates into a series of allegations and counter allegations, the editor in chief of Fertility and Sterility has been accused of defamation and threatened with legal action by Dr. Cha. However, the BMJ has also learnt that following an investigation by the public prosecutor’s office in Korea, Dr. Sook Hwan Lee, one of Dr. Cha’s coauthors on the disputed paper, has been charged with criminal copyright infringement. The dispute is a major embarrassment for the CHA organisation, which only recently hired Professor Kwang Soo Kim, a respected Harvard professor, to boost its credibility in stem cell research."
Gornall continued:

"On 7 March, Dr.(Alan) DeCherney (editor of Fertility and Sterility) received a letter from lawyers acting on behalf of Dr. Cha. It quoted comments attributed to him in the LA Times on 18 February and in The Scientist on 20 February and accused him of having made 'false and defamatory statements' about Dr. Cha. It threatened legal action and demanded that Dr. DeCherney sign a statement of retraction. The letter, seen by the BMJ, calls for Dr. DeCherney to 'acknowledge that 1) Dr. Cha was entitled to be credited as an author of the F&S [Fertility and Sterility] article; 2) you have no reason to disbelieve Dr. Cha’s statement that he was unaware of the prior publication in the KSOG Journal; and 3) Dr. Cha did not plagiarise Dr. (Jeong Hwan) Kim’s work, in that Dr. Kim’s name was on the list of authors initially submitted to F&S by Dr. Lee, and was only omitted because he could not be located.'"
Gornall continued:
"Professor Kwang Soo Kim, director of the molecular neurobiology laboratory at Harvard’s Mclean Hospital and the newly recruited codirector of the CHA Stem Cell Institute, now finds himself having to defend his new employer. No fewer than three of his new colleagues at the institute including his fellow codirector, Hyung Min Chung are among the disputed authors on the paper. In February he wrote to Dr. DeCherney of Fertility and Sterility on behalf of the CHA organisation as 'a fellow research scientist with more than 23 years of research experience in the US as well as first-hand knowledge of standard practices in the scientific community in Korea,' to express regret about the incident.

"In his letter, a copy of which the CHA organisation sent to the BMJ, he suggests that 'The main issue that appears to be at the center of this controversy is the multiple publication of the paper.' But he then makes a disturbing disclosure: 'In Korea, it has been a customary practice and an accepted procedure by the scientific community to submit top-quality research outcomes concurrently (or subsequently) to internationally-recognized journals in an effort to promote and advance the work of Korean scientists, which was also the case when Dr Lee submitted her paper to Fertility and Sterility.

"'I personally have very strong objections to this practice and have been trying to convince the scientific leaders in Korea to put a stop to this. It was only recently in 2006 that this guideline was in fact revised in Korea to prohibit this practice.'

"Professor Kim’s intervention leaves little doubt about how seriously the CHA group views the potential of the incident to damage its bid to inherit Hwang’s crown: 'The reputation and credibility of our university and that of its researchers and scientists are also at stake,' Professor Kim writes. 'This is an extremely critical issue in light of the fact that I believe our institution will serve a pivotal role in restoring the severely damaged reputation and credibility of stem cell and life science research in Korea after the Hwang scandal.'"
We have queried DeCherney concerning his response to the letter from Cha's lawyers.

For previous items on the the CHA story, see "Secrecy," "Example," "CGS" and "FTCR." Sphere: Related Content

Thursday, April 05, 2007

Time to Give Fax Machines a Decent Burial

Fascimile transmission seems akin to the Linotype. At least to this writer, who is boggled by several recent communications that could only be received via antiquated technology. (This item, by the way, is not really about CIRM or stem cells.) Why anyone would want to use fax instead of email or other electronic transfer methods is hard to understand. It seems a waste of time and particularly a waste of physical storage space, which is undoubtedly more expensive than digital storage. Perhaps we are missing something concerning the use of fax. If so, hopefully someone can enlighten us. Sphere: Related Content

Criticism: The Price for a CIRM Grant

The California stem cell agency is breaking into some of the cloistered halls of science with criticism that publicly labels one scientist "naïve" and calls another scientist's proposal potentially irrelevant.

Of course, the sting of the criticism is soothed with the balm of multimillion dollar research grants.

Reporter Carl Hall of the San Francisco Chronicle recently sliced a bit deeper than other reporters into the public summaries of the grants won by California scientists, noting that they "offer a rare glimpse into the traditionally cloistered world of scientific peer review. He quoted Arlene Chiu, director of scientific programs at CIRM, as saying,
"The NIH doesn't show any of this kind of thing going on, This is the first time you can see how people criticize one another."
Arnold Kriegstein, chief of the UC San Francisco stem cell program, was the target of a comment that he was "naïve" on some technical matters. He told Hall he was a victim of his own brevity and may have been misunderstood "in certain technical aspects." His bruises were nicely tended with a $2.5 million grant.

Alice Tarantal, a pediatrics professor at UC Davis, described the review as a "very fair process" although some reviewers questioned how relevant her model was from a clinical perspective. She received a $2.3 million grant.

The names of those criticized are only publicly released after the grants are approved, although some persons very familiar with stem cell research could identify at least some of the scientists in advance based on the nature of their work. The names of those who fail to win grants are not released.

We have written often about unwarranted secrecy in the grant process. But the public summaries are an excellent step in the right direction and CIRM should receive ample credit for providing them.

Hall should also receive credit for bringing them to a higher level of public visibility.

In another grant-related story, reporter Terri Somers of the San Diego Union-Tribune looked more closely at some of the recipients of CIRM grants, including those relatively new to the field. She described how their research is cutting across specialities with the hope of transforming the field.

One example is a $638,000 grant to UC San Diego professor Shu Chien, a medical doctor and pioneer in bioengineering. Somers wrote:"'His team will use a testing system he helped to develop so they can simultaneously look at thousands of proteins and their effects on different cells.

"'So instead of doing these tests one by one in a test tube, which could take years, we can do them all at once,' Chien said." Sphere: Related Content

Wednesday, April 04, 2007

Salon.com Looks at Industry Opposition to SB771

The headline on Salon.com read: "Biomedical industry to California legislators: 'Don't you dare tell us what to do with your money!'"

Andrew Leonard, a California author and regular on Salon.com, continued:
"The horror! To CHI (California Healthcare Institute), SB 771 is unwarranted state intervention in their profit-making potential, an act of robbery that must be resisted with extreme prejudice."
Leonard referred to the excerpts of a CHI letter seen on the California Stem Cell Report in the "Biomedical Industry" item below.

He wrote:
"As a citizen of California who voted for the state's landmark stem cell initiative, and whose tax dollars will go toward paying off the bonds issued to pay for it, I fully support legislative efforts to ensure that some of the revenue generated by the commercialization of research paid for with my money return to the state....

"If the biomedical companies don't like it, they can just go find someone else's money to play with."
Leonard also said,
"Whatever happens, I look forward to following the twists and turns of California's ambitious attempt to bootstrap stem cell research via the reporting at the California Stem Cell Report blog. I have a particular weakness for blogs that obsessively cover every iota of news about a single, highly circumscribed topic -- they seem to regularly expose me to information that is not easily found elsewhere."
Sphere: Related Content

Baristas to Bioworld: More on WARF Ruling Impact

More coverage and commentary on the WARF patent ruling is filtering in today.

From Randall Osborne, west coast editor of Bioworld, comes this:
"'It's a big thing,' said Paul Lesko, patent attorney with SimmonsCooper in East Alton, Ill. 'Most times there will be at least an amendment, if the patent survives,' although the process could take years.

"'When it comes to a [final PTO action], I'd say a wholesale rejection is more common than anything else,' Lesko said, especially with patents that contain claims that are fewer in number, like WARF's.
From the Patent Baristas blog, Stephen Albainy-Jenei writes:
"I don’t think anyone should go out and throw a party just yet. The patent office grants over 90 percent of the requests for reexamination and many of those patents are issued with substantially the same claim(s) as before reexamination. WARF, a nonprofit group that acts as UW’s tech transfer office, will have a chance to prove the cells are novel. And, if the claims are ultimately rejected, it can still appeal or narrow the claims. This could take years to resolve."
Joff Wild, editor of Intellectual Asset Management magazine, says WARF is now on the "defensive" and adds:
"Although WARF changed its licensing policy earlier this year, 20 years worth of income from its stem cell portfolio still potentially represents a colossal amount of money."
Sphere: Related Content

Tuesday, April 03, 2007

California's Biomedical Industry Lays Out Opposition to SB771

The chief lobbying group for the California biomedical industry Tuesday detailed its strong opposition to legislation that seeks to guarantee that California reaps an economic and health-related return on its $3 billion stem cell research investment.

David Gollaher, president of the 250-member organization, said the bill, SB771, will "create significant disincentives for firms to commercialize inventions funded with CIRM money. And without company participation, basic stem cell science cannot be developed into treatments for patients."

CHI's opposition was laid out in a five-page letter to Sen. Sheila Kuehl, D-Santa Monica, co-author of the bill and chair of the Senate Health Committee. It was also sent to Senate Republican leader George Runner of Antelope Valley, co-author of the measure, and all Republican members of the California Senate.

CHI is also unhappy with CIRM's own provisions for sharing the wealth on any inventions that stem from CIRM-funded research.

CHI's letter said:
"Because commercialization is essential for the development and production of new medicines that can be used by Californians and others, CHI believes that the basic goal of intellectual property policies should be to minimize barriers to transfer technologies from basic research laboratories to the private sector for commercialization into products. Moreover, while we strongly support policies to improve patients’ access to advanced medicine, we maintain that IP policies and regulations are not the way to improve access and cost.

"Investment in biotechnology is inherently very risky. Any aspect of a technology transfer contract that increases risk, particularly by adding an element of uncertainty, makes it less attractive to potential partners and investors and thus reduces the prospects for successful commercial collaboration.

"We believe the intellectual property policies in your measure would reverse the improvements thoughtfully considered and accepted by the ICOC (CIRM's Oversight Committee) during several public meetings. SB 771 would impose more stringent revenue sharing and pricing and access provisions than those finally adopted by the ICOC.

"Additionally, we believe that codifying IP provisions in statute will deny the ICOC the flexibility it may need to amend its IP policies in the event they prove to be unworkable. As you know, the CIRM has just begun to issue research grants and it will likely be a number of years before any discoveries from this research moves to the commercialization stage. Thus, the ICOC may not know for some time if the IP policies it has adopted are effective and will need flexibility to change its IP policies if the situation warrants."
The letter concluded by saying that CHI questions
"...the appropriateness of commercial companies being forced to pay royalties, beyond what they negotiate with basic research institutions. If additional payments like this are required, along with the revenue sharing, pricing and access clauses mentioned above, they will only serve as an additional disincentive to commercial participation in CIRM-funded research."
The CIRM Oversight Committee is scheduled to discuss SB771 on April 10. Three members of that group are also directors of CHI. They are Ted Love, CEO of Nuvelo; Richard Murphy, head of the Salk Institute, and Philip Pizzo, dean of the Stanford School of Medicine.

The Senate Health Committee takes up the legislation on April 11. We have asked Kuehl's office if it would like to comment on the CHI letter. Sphere: Related Content