Sunday, April 23, 2006

Pittsburgh Tribune-Review comes down hard on Schatten, UPitt

According to Jennifer Bails: The University of Pittsburgh's lax policies and disregard for federal guidelines allowed biologist Gerald Schatten to participate in one of the biggest scientific frauds in history.

The Tribune-Review reported:

--> Pitt allows its scientists to determine if their work constitutes human-subject research, a policy that disregards federal recommendations designed to safeguard people.

--> A Pitt oversight board skipped a full review of Schatten's research after he assured them it did not involve identifiable people. Documents show the opposite is true. One of those people, an egg donor, later worked in Schatten's Oakland lab.

--> Pitt's inaction permitted Schatten to proceed with publishing his research. He sought the university's clearance only after his work was completed.

--> Pitt opts to withhold privately funded research, such as Schatten's, from federal oversight, a choice that makes the university unaccountable when it comes to protecting human volunteers in studies.

--> Newly proposed stem cell rules at Pitt likely would have prompted the university to take a closer look at Schatten's research. A closer look might have uncovered irregularities before the work was published.

"A stem cell trial like this without full review should just never, ever happen," said Glenn McGee, editor-in-chief of the American Journal of Bioethics and founder of the nation's largest research program on the ethical implications of stem cell science. "The University of Pittsburgh should take the lead in the nation to ensure that this option is never provided, since they are the ones that did it wrong."

Although the Tribune-Review reported: Six months later (after June 05), a Korean investigation revealed that Hwang and possibly others deliberately fabricated data for the paper, which Science later retracted. the Tribune-Review did not focus on the investigation by Korea's PD Notebook, which stated in May 2005.

The Tribune-Review continued:

In many ways, Schatten was the brains behind the research. He reviewed figures and tables, analyzed and interpreted data generated in Korea, drafted versions of the manuscript and communicated with journal editors. As senior author of the Science paper, he was responsible for its integrity. [IPBiz note: both Hwang and Schatten were listed as contact authors on the 2005 paper in Science.]

Scientists are supposed to seek formal written clearance from an IRB before beginning their research when there is any question about whether a project might involve human subjects, Caplan said.

"Basically, you shouldn't be sending out anything until you have that letter in hand," Caplan said.

Duffield said Schatten first approached Pitt's IRB about his collaboration with the Korean scientists in February 2005, at least a month after the project had begun.

He informed the board that his collaboration with Hwang did not involve identifiable people, she said. This declaration prompted the board to determine it had no jurisdiction over the work, she said.

"Based on the information provided to the IRB, this project includes no involvement of human subjects, according to federal regulations," states a letter sent to Schatten on March 16, 2005, signed by Christopher M. Ryan, a Pitt neuropsychologist who is vice chair for the board's exempt and expedited reviews.

The day before, Schatten and Hwang submitted a first draft of their paper to Science.

Ethical obligations

Ryan, who did not return phone calls or e-mails, wrote to Schatten that the review board made its decision because "the investigator conducting research ... will not obtain identifiable private information."

The board used as a reference federal guidelines issued in March 2002 that say the study of human cell lines, where the donors cannot be identified by the investigator, is not human-subject research, Ryan's letter said.

But an online supplement that Schatten and his Korean co-authors published with their Science 2005 paper indicates otherwise.

The supplement says that when patients donated their cells for the research, their identities were "encoded by the responsible clinician and donor identity was unknown to the investigators and others."

Under Korean law, as explained in that supplement, the families of these donors must receive priority for any future treatments that result from the research to which they contributed.

The Tribune-Review provided a timeline:

A chronology of events surrounding University of Pittsburgh scientist Gerald Schatten's role in fraudulent Korean human embryonic stem cell research.

March 15, 2005: Schatten and Korean researcher Dr. Hwang Woo-Suk submit a paper to the journal Science, claiming creation of patient-matched stem cells by cloning of human embryos.

March 16, 2005: Pitt's Institutional Review Board overseeing human subjects research sends Schatten a letter saying his project does not involve human subjects, which means it will not review his work further.

June 17, 2005: Paper is published in Science. [IPBiz note: this is the paper copy. The electronic version came out in May.]

Nov. 11, 2005: The authors of the paper submit corrections to Science, saying they created fewer cloned cell lines than they originally reported. [?]

Nov. 14, 2005: Schatten publicly severs ties with Hwang over ethical concerns about human egg procurement.

Dec. 4, 2005: Hwang contacts Science to report some cell images submitted as part of the paper unintentionally showed the same thing.

Dec. 6, 2005: Pitt's research integrity officer, Jerome L. Rosenberg, learns of a Korean news report questioning the validity of the research.

Dec. 14, 2005: Pitt notifies Schatten that it has opened an investigation two days after he asks Science to remove his name from the paper.

Dec. 15, 2005: Seoul National University (SNU) opens an investigation.

Dec. 23 and 30, 2005; Jan. 10, 2006: SNU announces in three stages that the supposed cloned cell lines did not exist.

Jan. 12, 2006: Science editors retract paper.

Feb. 8, 2006: Pitt panel appointed by Dr. Arthur Levine finds Schatten did not commit research misconduct, but said he shirked his responsibilities as co-author of the paper. It recommends the university take corrective or disciplinary action.


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