Unsettled in wake of Potti settlement

It was announced early last month that the 2011 lawsuit regarding former University cancer researcher Anil Potti had been settled with undisclosed terms. Between 2006 and 2010, 127 cancer patients participated in Potti’s three clinical trials based on invalid medical research, some receiving inappropriate chemotherapy treatments. The Editorial Board called five years ago for greater transparency from Duke’s administration, and today even more questions remain unanswered, raised by news of a whistleblower quieted early in the case as well as the Institute of Medicine’s external review about how other challenges to Potti’s work were badly mishandled by School of Medicine professors and administrators.

The case began in 2006 when Potti introduced a novel approach to cancer treatment that claimed a patient’s chemotherapy could be personalized to genetic models of their specific tumor. In 2009, however, biostatisticians Keith Baggerly and Kevin Coombes from Houston published concerns that Potti’s findings could not be replicated. They also found that even if the research was valid, “sensitive/resistant” axis labels had been reversed and patients could be receiving the opposite of correct treatment. After an internal University investigation and a report from The Cancer Letter—a national cancer research publication—that Potti’s resume contained false credentials, the clinical trials were terminated in 2010. Potti also retracted more than 10 papers and resigned from positions in the School of Medicine and now disbanded Institute for Genome Sciences and Policy.

Though the lawsuit has been settled for the families of several patients, the 2012 Institute of Medicine’s investigation of the case badly indicts Duke’s handling of Potti’s research. Their report explains how several levels of oversight like the Institutional Review Board were ineffective or purposefully weakened and ignored by professors and administrators in processing concerns about Potti’s research. For example, former vice dean for research at the School of Medicine and current provost Sally Kornbluth was not made aware of the conflicts of interests of researchers with conspicuous patents and financial investments in the lab’s research. Additionally, Potti’s research mentor Joseph Nevins was allowed by University leadership to withhold the Baggerly and Coombes report that highlighted problems with the lab’s research from external reviewers in addition to other meddling.

But more alarming than these failures is the alleged cover-up where Duke administrators and professors quieted whistleblower Bradford Perez—a third-year medical student in Potti’s lab—who came forward in early 2008 with grave and quantified doubts about the lab’s work. Perez had prepared a document titled “Research Concerns” but was told by Nevins that moving forward could make future funding difficult and prompt a difficult internal investigation. Further, Kornbluth headed off exposure of Perez’s reservations in 2010 in since released emails and stated oddly that researchers from Potti’s lab came forward only after the University’s investigation, though Perez had come forward in 2008.

Though Duke made moves in 2011 towards a culture of “dissent and discussion” to increase faith in the whistleblowing system, that was before the Institute of Medicine’s 2012 report and well before this year’s news of Perez and his treatment. The move needed now is an explanation of how those party to these ethical breaches and cover-up were held accountable by the University, if at all, for allowing these oversight and integrity failures. Rather reasonably, scientific misconduct expert C.K. Gunsalus asserts that “Duke owes information and actions to its patients, the research community and to its medical professionals, students and faculty.”

The administration’s silence began in 2011 because it would not comment on pending litigation. Now, that silence continues for the terms of the suit settlement per those same terms and also unfortunately extends to silence on the whole issue, including Perez’s whistleblowing. We believe the reputation of Duke’s School of Medicine demands public statements from administration to clear the haze around their handling of Potti’s case, but commentary has yet to be given for students, professors and researchers to understand how the lessons from this case are being applied to prevent such individual and systemic oversight failures in the future.

Editor’s Note: This editorial was written by members of staff rather than The Chronicle’s independent editorial board.