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.

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."

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.)

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."

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.

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.

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.

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.

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."

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.

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."

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.)

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.

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.

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."

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.

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

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