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Three clinical trials suspended while Duke investigates Potti

Three clinical trials have been shut down at Duke as the University investigates allegations that Anil Potti, an associate professor of medicine and cancer researcher, falsely claimed to be a Rhodes scholar on applications for federal funding.

As of July 18, researchers stopped admitting new patients into programs that rely on Potti’s work—genomic technology used to match specific chemotherapy treatments with patients. Individuals whose treatment already relies on Potti’s work are not at risk, however, as the treatment they receive follows standard medical practices, said Dr. Michael Cuffe, vice president for medical affairs, according to The (Raleigh) News and Observer.

“To be clear, Duke immediately began an internal process to investigate the allegations as soon as we became aware of them,” President Richard Brodhead wrote in an e-mail Tuesday. “That process is still underway, and until it is completed we need to respect both Duke policies and legal requirements for privacy. We take matters like this very seriously and are moving as quickly and thoroughly as possible to understand the facts.”

Duke has placed Potti on administrative leave. The American Cancer Society has suspended payments on the $729,000 grant that Potti received for his research, the application for which Potti is listed as a “Rhodes Scholar (Australia).” Potti did not respond to a July 21 e-mail requesting an interview.

“We are extremely concerned about these allegations as we take accuracy in the scientific process very seriously,” wrote David Ringer, vice president for extramural grants for the American Cancer Society in a letter to the dean of the School of Medicine obtained by The Chronicle. “We ask that you provide us with an official curriculum vitae for Dr. Potti and an explanation of any variance it may have from the one included in his grant application (copy attached). We are also interested in what action you are taking to assure that the funded work has been done to the highest standards of science, accuracy and integrity.”

The Rhodes Scholarship brings students from around the world to study at the University of Oxford in England—not Australia—according to the organization’s website. The Rhodes Trust has no record of Potti ever having received a Rhodes Scholarship, according to The Cancer Letter, the newsletter that reported the allegations that Potti had made false claims on his applications for funding.

The review of Potti’s work is not the University’s first since his arrival in 2003. Administrators previously investigated research connected to Potti after biostatisticians Keith Baggerly and Kevin Coombes of MD Anderson Cancer Center found errors in the researcher’s work, according to The Cancer Letter. Although clinical trials were briefly suspended, Duke officials eventually allowed the trials to be restarted after completing the investigation. But after reviewing the reports of the University’s review, Baggerly and Coombs said that the investigation’s documents do not adequately validate the study’s work, according to The Cancer Letter.

More recently, a July 19 letter signed by 33 biostatisticians addressed to Harold Varmus, director for the National Cancer Institute, urged the organization to suspend the trials until a more rigorous investigation of Potti’s work is completed.

“Recently, published and peer-reviewed re-analyses of the work done by Potti and Nevins revealed serious errors that questioned the validity of the prediction models upon which these ongoing clinical trials are based,” the letter said. “This led to a temporary suspension of the trials and a Duke-led review involving independent statistical experts. However, despite written statements from the external experts, who uniformly stated they were not given sufficient information to confirm the validity of the models, the trials have been reinitiated.”

The letter’s authors requested that more detailed information be released so that the findings can be validated. Only after a more rigorous investigation should the clinical trials be resumed, the letter added.

Paul Goldberg, Trinity ’81 and the author of the article in The Cancer Letter that first charged Potti with having falsified his resume, said the situation is now an institutional problem for Duke and no longer the matter of a single dishonest researcher.

"It could have been the problem of a rogue researcher based on silence—now it's the problem of the rogue researcher and the administrators that protected him,” Goldberg said. "This is a question of the administration. They are taking a problem that they could have solved, and turning it into a problem that is structural to the institution."

Dr. Victor Dzau, chancellor for health affairs and president and chief executive officer for the Duke University Health System, did not immediately respond to request for comment sent Monday night.


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