January 14

Cloning Scam: Dr. Gerald Schatten’s Hand in Bogus Paper Detailed

“Whoever holds the patent for creating embryonic stem cells from cloned human embryos could earn a fortune if the technology works.”
"Fraudulent research is a particularly disturbing event, because it threatens an enterprise built on trust," said Science editor-in-chief Donald Kennedy. The stem-cell cloning research scam is a dramatic demonstration of the failure of the current journal peer-review system whose culture of elitism allows reports penned by prominent academics–many of who have never seen the original data—to defile the scientific literature.

In this era of commercially-driven medical research—whether conducted by industry or academia—it behooves journal editors—no matter how prestigious the authors submitting articles for publication—to at least follow Ronald Reagan’s dictum, “trust but verify.”
The Pittsburgh Tribune Review reports (below): “Until now, Schatten hadn’t been directly connected with the 2004 research.” However the 49-page report by a panel convened by the Seoul National University (SNU) reveals new details about Schatten’s role in publishing the falsified 2004 paper.”
"If you are a senior author, you have to do more than just accept the integrity of the scientific process that you believe is going on. You have to be part and parcel to it… University of Pittsburgh had to have given permission for [Dr. Gerald Schatten] to enter into that collaboration,"  said John Gearhart, a professor of medicine at The John Hopkins University’s McKusick-Nathans Institute of Genetic Medicine in Baltimore.
 
The thorough, expeditious way that the Seoul National University (SNU) has dealt  with scientific fraud by a prominent faculty member contrasts sharply with the evasive, “no comment” foot dragging technique used by US academic institutions when faced with allegations of research misconduct involving senior faculty members who bring in lucrative research grants and patent exclusivity to the institution.

Dr. Hwang Woo-Suk was not the only one involved in the stem-cell cloning research scam. The Pittsburgh Tribune Review reports (below):
 
"An academic panel investigating the work of South Korean researcher Hwang Woo-Suk revealed Tuesday the deep involvement of University of Pittsburgh reproductive biologist Gerald Schatten in preparing stem cell papers based on bogus data….Schatten was listed as senior author of the 2005 paper. Schatten also acted as a liaison between the editors of Science and Hwang while the 2004 paper was under review, although Schatten’s name did not appear on the article."  “The papers, now being retracted, falsely claimed that scientists had created embryonic stem cells from cloned human embryos.”

Both Dr. Hwang Woo-Suk and Dr. Gerald Schatten submitted numerous stem cell patent applications which are on file at the World Intellectual Property Organization and the U.S. Patent and Trademark Office. None were disclosed in the March 2004 and June 2005 Science articles.

The Center for Science in the Public Interest calls upon the editors of Science and Nature to strengthen their conflict-of interest disclosure policies. In light of the revelation of ghost written articles that have irrevocably tainted the entire scientific literature, the Alliance for Human Research Protection calls for more than mere financial disclosure statements. We call upon ALL scientific journals to require ALL authors to submit the original data with their manuscripts for independent review and analysis.

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
 

http://pittsburghlive.com/x/tribune-review/health/s_413111.html

Pittsburgh Tribune-Review
January 13, 2006
Cloning scandals prompt review
By Jennifer Bails

Spurred by the Korean cloning scandal, editors of Science said Thursday they will review financial reporting procedures for scientists submitting papers to the journal.
Science requires manuscript authors to disclose any "planned, pending, or awarded patent on this work by you or your institution." Science editors then determine whether the disclosure should be published as part of the article.

Two fraudulent papers published in Science by disgraced Korean veterinarian Hwang Woo-Suk in March 2004 and June 2005 did not include any conflict-of-interest disclosures. University of Pittsburgh biologist Gerald Schatten was listed as senior author of the 2005 paper.

Schatten also acted as a liaison between the editors of Science and Hwang while the 2004 paper was under review, although Schatten’s name did not appear on the article.

The papers, now being retracted, falsely claimed that scientists had created embryonic stem cells from cloned human embryos.
Whoever holds the patent for creating embryonic stem cells from cloned human embryos could earn a fortune if the technology works. Anyone wanting to use the technology or the patented cells to find cures to disease or injury would have to pay the patent-holder to license it.
Hwang has at least seven patent applications related to cloning or stem cells with the World Intellectual Property Organization, all of which predated publication of the 2005 paper.
Schatten and Pitt scientists Calvin Simerly and Christopher Navara filed a U.S. patent application April 9, 2004, for methods that would make human cloning "a practical procedure." These methods also could be used to derive embryonic stem cells to treat disease, according to the application.
Neither Hwang nor Schatten list each other as co-inventors on their patent applications.

In the conflict-of-interest statement supplied to Science for the 2005 paper, Hwang replied on behalf of all authors and checked a box to designate that a patent was "anticipated, applied for, or held," according to Editor-in-Chief Donald Kennedy. He did not supply requested details about the patent, Kennedy said.

"At this point, we do not know whether the patent is awarded or expected, and whether it is Dr. Hwang’s or one of the other authors,’" Kennedy said in an e-mail response to questions. "Our retrospective review of our procedures that we will be conducting shortly will include an evaluation of our conflict-of-interest policies."
Pitt spokeswoman Michele Baum said no one from the university would comment about the patent situation until a closed-door panel completes its investigation to determine if Schatten engaged in scientific misconduct in connection with the Korean research. A ruling is expected next month.

Schatten could not be reached for comment.
Jennifer Bails can be reached at jbails@tribweb.com or (412) 320-7991
~~~~~~~~~~~

http://www.pittsburghlive.com/x/tribune-review/trib/regional/s_412326.html
Schatten’s hand in bogus paper detailed
By Jennifer Bails
TRIBUNE-REVIEW
Wednesday, January 11, 2006

An academic panel investigating the work of South Korean researcher Hwang Woo-Suk revealed Tuesday the deep involvement of University of Pittsburgh reproductive biologist Gerald Schatten in preparing stem cell papers based on bogus data.

Schatten acted as a liaison among Korean researchers, American scientists and journal editors overseeing publication of the falsified articles, and in one case, wrote multiple drafts of a paper and signed off on the accuracy of the final version, according to a report by the Seoul National University panel posted online in Korean yesterday.

Hwang — who rose to international fame after claiming to have extracted stem cells from a cloned human embryo — fabricated the evidence for that research, published in the journal Science in March 2004, the SNU panel announced yesterday.

Based on the university panel’s findings that data were fabricated, the editors of Science said yesterday they would retract the 2004 paper.

Until now, Schatten hadn’t been directly connected with the 2004 research. The panel’s full 49-page report, translated for the Tribune-Review by Sung Joon-Kim, a Washington, D.C., correspondent for Seoul Broadcasting Systems, reveals new details about Schatten’s role in publishing the falsified 2004 paper. The report does not say whether Schatten knew the data were fraudulent.

"Fraudulent research is a particularly disturbing event, because it threatens an enterprise built on trust," said Science editor-in-chief Donald Kennedy. "Fortunately, those cases are rare — but they damage all of us."

A second paper, published in June 2005, also in Science, claimed Hwang later had developed 11 embryonic stem cell lines tailored to specific patients — a landmark finding that many hoped would be the first step toward healing patients with incurable ailments like diabetes and Parkinson’s disease by using their own tissue.

Last month, the SNU panel said there was no evidence to support the 2005 paper, prompting Science to retract the article. Schatten was listed as a senior author on the fraudulent 2005 paper.

Yesterday’s SNU report on the 2004 paper states that:

= Schatten helped Hwang and SNU colleague Kang Sung-Keun respond to follow-up questions about the paper — which had been submitted to Science in December 2003 — from its peer reviewers. The paper had been submitted in May 2003 to the leading British journal Nature, but was rejected. Nature spokeswoman Ruth Francis couldn’t confirm this report yesterday.

= Schatten, who heads the Pittsburgh Development Center at Magee-Womens Research Institute, also helped arrange telephone conversations among the editors of Science, Hwang and Kang about the 2004 article.

= Hwang offered Schatten a position as co-author of the 2004 paper, but Schatten declined.

Pitt spokeswoman Jane Duffield said that she could not verify SNU’s findings and that Schatten was not available for comment.

A six-member panel at Pitt is investigating whether Schatten committed research misconduct in connection with Hwang’s 2005 paper and another article they co-wrote in Nature purporting to have created the first cloned dog.

The now-discredited 2004 Science paper is not part of the scope of the Pitt investigation, Duffield said.

Pitt launched its closed-door panel in early December. It is conducting interviews and might not issue its public findings until February, Duffield said. The Pitt report originally had been expected later this month.

With the financial support of the Magee-Womens Health Foundation, Schatten served as an adviser to help analyze, interpret and write up the results for the 2005 Science paper, but did no experiments.

Stem cell pioneer John Gearhart said Schatten’s decision to accept the responsibility as senior author of the Korean paper and promote the research without overseeing the lab work was the Pitt scientist’s biggest mistake.

"If you are a senior author, you have to do more than just accept the integrity of the scientific process that you believe is going on," said Gearhart, a professor of medicine at The John Hopkins University’s McKusick-Nathans Institute of Genetic Medicine in Baltimore. "You have to be part and parcel to it."

Schatten cooperated with Korean investigators, Duffield said. Their report provided a more detailed timeline of his involvement in the 2005 Science paper:

*    On Jan. 4, 2005, Schatten received the data from the Korean scientists needed to write the paper, and a week and a half later met with Kang at a seminar to discuss the draft.

*    On Jan. 21, 2005, Schatten sent Kang his first draft, which claimed four cloned stem cell lines and efforts to make four more.

*    On March 5, 2005, Schatten received additional data from Kang that accounted for 10 cloned stem cell lines. Schatten sent the Korean researcher questions about this information. Kang’s reply the next day added another cell line.

*    On March 7, 2005, all 25 co-authors on the paper signed a cover letter attesting that they had read the paper and agreed with its results.

*    On March 12, 2005, Schatten finished a second draft. Three days later, Schatten sent a final version claiming 11 cloned stem cell lines to Science.

Any fallout Schatten experiences from the Korean cloning scandal should serve as a lesson to scientists seeking to engage in long-distance collaborations, said Gearhart.

"If someone is trying to be duplicitous, it is really easy to be misled," said Sue O’Shea, a professor of cell and developmental biology at the University of Michigan in Ann Arbor, which houses one of the nation’s few centers to do research with government-limited lines of human embryonic stem cells.

Gearhart also questioned Pitt’s role in Schatten’s involvement with Hwang.

"University of Pittsburgh had to have given permission for Jerry to enter into that collaboration," Gearhart said. "The other issue is what information from Korea was revealed to the university for him to get the OK to work with those people."

The SNU panel announced yesterday that "Snuppy," Hwang’s cloned Afghan hound, appears to be the real thing, based on genetic tests.

The editors of Nature said yesterday that they tentatively accept these findings, but scientists at the National Human Genome Research Institute will continue independent testing of Snuppy.

Jennifer Bails can be reached at jbails@tribweb.com or (412) 320-7991.

~~~~~~~~~
http://cspinet.org/new/200601121.html
CSPI NewsRoom
January 12, 2006

CSPI Calls on Journals to Strengthen Disclosure of Conflicts
 
The Center for Science in the Public Interest (CSPI) is calling on the editors of Science and Nature, the world’s two most prestigious science publications, to strengthen their conflict-of-interest disclosure policies. Both Drs. Hwang Woo-Suk of Seoul National University and Gerald Schatten of the University of Pittsburgh have numerous stem cell patent applications on file at the World Intellectual Property Organization and the U.S. Patent and Trademark Office. None were disclosed in the March 2004 and June 2005 Science articles describing somatic cell nuclear transfer or the August 2005 Nature article describing the cloning of Snuppy the Afghan hound.

CSPI Integrity in Science director Merrill Goozner called on the editors to strengthen their conflict of interest disclosure policies by requiring authors to declare all financial conflicts of interest, including patents and patent applications, whose value may be affected by publication; to tell authors they will publish those conflicts; and to impose a three-year ban on authors who fail to disclose any financial conflicts from publishing in the journals for three years. The government-sponsored journal Environmental Health Perspectives has such a ban.

"Science and Nature should take the lead in the wake of this scandal," said Goozner. "In a world where financial incentives can warp the scientific enterprise just as much as the lust for scientific prestige, it is incumbent that journal editors have strict conflict-of-interest disclosure policies. And, given the voluntary nature of disclosure, they should have teeth like a three-year ban on publishing for failing to disclose."

 
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