JCO acts on request for retraction

Three weeks after Dr. Joseph Nevins e-mailed co-authors of a paper acknowledging it needed to be retracted, The Journal of Clinical Oncology has formally granted the request.

JCO formally retracted the paper titled “Pharmacogenomic Strategies Provide a Rational Approach to the Treatment of Cisplatin-Resistant Patients With Advanced Cancer” Tuesday. The article described a gene-based method of predicting patient response to cancer treatments and served as the basis of two cancer clinical trials being conducted at Duke that were recently terminated.

The lead author of the paper was Dr. Anil Potti, who has been accused of making false claims on his resume and producing flawed research. Although Potti has not spoken to the media since allegations against him surfaced, the retraction indicates that he signed a statement approving the retraction and its wording, because it is JCO’s policy not to retract an article without permission from all of a paper’s authors.

A statement released by JCO noted that the authors wished to retract the article because they were unable to replicate experimental results that were “fundamental to the conclusions of the paper.”

“We deeply regret the impact of this action on the work of other investigators,” JCO noted.

In an Oct. 22 e-mail to the 13 co-authors of the paper, Nevins, Barbara Levine professor of breast cancer genomics and director of the Center for Applied Genomics and Technology, wrote that the research published in 2007, “cannot show a capacity to distinguish responders and non-responders when the correct clinical information was used, contrary to what was reported in the paper.”

Two biostatisticians from M.D. Anderson Cancer Center, Keith Baggerly and Kevin Coombes, first raised concerns about the paper about a year ago. In light of their questions, the three trials were suspended in October 2009, but the University restarted them in January after an internal review did not find concerns warranting their termination.

“I wonder if we should have caught it earlier, or if [Nevins and Potti] should have caught it earlier,” Dr. Victor Dzau, chancellor for health affairs and president and CEO of the Duke University Health System, told The Chronicle in late October. “I think [it took] a deep dive, particularly by Dr. Nevins and new statisticians, to go through point by point and line by line to look at this issue.”

It remains unclear whether or not the patients who were enrolled in the trials were harmed as a result of their participation. Dr. Otis Brawley, chief medical officer of the American Cancer Society, said in an interview with The Chronicle in October that he was “starting to worry” that the trials caused harm, though he added that he was waiting for the results of a review being conducted by the Institute of Medicine.

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