Anil Potti's research was hailed as the "holy grail" in cancer treatment. Now, the federal government has affirmed what many say they already suspected—that Potti fabricated the data.
Potti claimed that he and his team at Duke University had found a way to predict, with up to 90% accuracy, which patients with early-stage lung cancer would benefit from chemotherapy. Potti also said he could analyze genes to predict what type of chemotherapy would best benefit patients.
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Colleagues praised Potti's work as the "new frontier" in lung cancer treatment, with one saying it could save at least 10,000 lives annually. The research was initially published in the prestigious journal Nature Medicine and was later included in eight other journals, including JAMA and the New England Journal of Medicine.
But while many in the medical sphere were excited over Potti's research, others had their doubts.
Researchers were unable to replicate his team's work, and Potti resigned from Duke in 2010 after the university determined data from his trials were flawed and he was found to have lied about being a Rhodes Scholar. Two medical boards reprimanded Potti, the university settled a lawsuit from subjects in clinical trials based on his work, and all nine journal articles on his findings were retracted.
The Office of Research Integrity (ORI) declared on Monday in the Federal Register that Potti "engaged in research misconduct" by including altered data in published papers and grant applications. The report represents the first official finding that Potti fabricated data, according to Retraction Watch.
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The ORI report found that, among other misconduct, Potti in a grant application said six out of 33 patients responded positively to treatment—when only four patients were actually enrolled in the study, none of whom responded positively to treatment. Potti also mislabeled CT scans and revised the responder status for dozens of subjects.
According to the report, Potti "neither admits nor denies ORI's findings of research misconduct" but has reached a "voluntary settlement" with ORI. Under the terms, any federally funded research conducted by Potti over the next five years must be supervised. In addition, any institution that supports him in conducting federally funded research must verify that the data are legitimately derived and accurately reported.
A Duke Medicine spokesperson told Retraction Watch in response to the report, "We are pleased with the finding of research misconduct by the federal Office of Research Integrity related to work done by Dr. Anil Potti. We trust this will serve to fully absolve the clinicians and researchers who were unwittingly associated with his actions, and bring closure to others who were affected" (Barbash, "Morning Mix," Washington Post, 11/9; ORI report, Federal Register, 11/9; Retraction Watch, 11/7; Mulcahy, Medscape, 11/9).
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