Cancer researcher at The Ohio State University resigns following multiple misconduct findings | Science

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Cancer researcher at The Ohio State University resigns following multiple misconduct findings | Science

The Ohio State University’s campus in Columbus

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A cancer researcher has resigned from The Ohio State University (OSU) in Columbus after the institution determined he had committed misconduct in eight papers. His work in designing anticancer compounds had led to millions of dollars in funding and multiple patents, as well as two compounds in clinical trials.

According to a 75-page report released today by OSU, a committee determined that cancer scientist Ching-Shih Chen was guilty of “deviating from the accepted practices of image handling and figure generation and intentionally falsifying data” in 14 instances in eight papers. The report recommends that Chen work with co-authors and journals to produce an “immediate retraction” of those eight papers, published between 2006 and 2014.

The investigation also prompted OSU to temporarily shut down research involving a compound developed by Chen; a phase Ib trial was suspended in June 2017. “Patient safety was never compromised,” according to the university.

Chen joined OSU in 2001; prior to that, he held faculty positions at the University of Kentucky in Lexington and the University of Rhode Island in South Kingstown. While at OSU, where he earned more than $200,000 per year, Chen did not keep a low profile: He held the position of Lucius A. Wing chair of cancer research and therapy, and in 2010 received the “Innovator of the Year award” from OSU. He has obtained more than $8 million in funding from the U.S. National Institutes of Health over the course of his career and published nearly 200 papers.

Chen holds multiple patents, the last one granted in March 2017. The company that was granted exclusive rights to the anticancer agents developed by Chen, Arno Therapeutics in Flemington, New Jersey, declared it was dissolving late last year.

According to a spokesperson for Arno Therapeutics, the problems with Chen’s papers had “zero impact” on the company’s drug development efforts. “We did separate clinical studies ourselves,” the spokesperson said, adding that the company decided to dissolve because of a “product failure in another therapeutic area. … Our decision had nothing to do with any internal activities at OSU.”

The university “hired an external consultant who validated that Chen’s research misconduct did not affect the Arno licensed compounds developed in his lab,” according to a statement from OSU released today.

Misconduct allegations in 2016

Chen resigned from OSU in September 2017. One month earlier, he stepped down as director of the Institute of Biological Chemistry in Taiwan; the institute still maintains a website for him, listing him as a “distinguished research fellow.” His attorney, David Ball of Rosenberg & Ball in Granville, Ohio, did not immediately return requests for comment.

According to the report, the investigation was prompted by allegations of misconduct in early 2016, involving six papers. The more the university investigated, the more potential issues it uncovered. The report notes: “In some cases, Dr. Chen indicated that there were no laboratory notebooks kept by members of the lab, rather individuals only had weekly progress reports and no daily records of the experiments they conducted.”

The university says it has “disclosed Chen’s investigation to appropriate federal authorities,” including the U.S. Office of Research Integrity (ORI) at the Department of Health and Human Services. If the ORI agrees that misconduct has occurred, it will issue its own findings, and a potential sanction, against Chen. Often, ORI findings are the first time a case of misconduct is revealed. OSU—which has been involved in a number of high-profile cases in the past few years, and hired a law firm to review its handling of such cases—says it wanted to alert the community once its report was finalized.

“On this case, with the strength of the evidence, the clear admission of misconduct by the researcher, and with the federal ORI’s understanding and awareness, the university was able to proactively share the investigation and results with the community,” Jennifer Yucel, OSU’s associate vice president for research compliance and the research integrity officer, told Retraction Watch and Science.

The documents released by OSU include an evaluation from The Weinberg Group—which consults on drug regulation—of the validity of multiple potential drugs related to a compound described in Chen’s papers, AR-42. Some of the evidence used to support AR-42—which works by inhibiting an enzyme that modifies histones (histone deacetylase)—includes four papers that contain “irregularities” in some of the data supporting AR-42. The outside experts concluded that the investigational new drugs remain “scientifically valid” even without the four papers, and the suspended trial “may be resumed without any risk to patients associated with the removed publications.”

For three papers, published between 2004 and 2014, the university recommended Chen contact the journals to issue corrections. “In the event that figures cannot be corrected with verified original research records, then retractions will be required.” The eight papers slated for retraction have been collectively cited more than 300 times, according to Clarivate Analytics.

This story is a product of a collaboration between Science and Retraction Watch.

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