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.

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.

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."

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.)

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.

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.

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.

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."

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.

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

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

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

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."