Duke has gotten one step closer to moving on from the Anil Potti scandal.
The University has settled a lawsuit involving the families of eight patients who were treated in clinical trials based on the discredited cancer researcher's work, Michael Schoenfeld, vice president for public affairs and government relations, confirmed via email Saturday. Potti falsified research that made it seem like he could use models to customize a patient's cancer treatment.
Schoenfeld wrote that the terms of the recently settled lawsuit are confidential and that he could not comment further.
He also noted that at this time there are no further claims pending related to Potti's research.
Thomas Henson, the lawyer for the plaintiffs, confirmed via email Sunday morning that the lawsuit has been resolved, and also noted that the terms of the settlement were confidential, by mutual agreement of the parties.
The news was first reported by Retraction Watch—a blog that covers scientific misconduct and retractions—Friday, Ivan Oransky, a co-founder of the site, confirmed Sunday morning.
Defendants in the case, which was originally filed in September 2011, included the University, Duke University Health System, Potti, Dr. Joseph Nevins—who co-authored many papers with Potti and served as his research mentor—and five others. The filing alleged that the defendants subjected the patients to fraudulent and dangerous clinical trials and improper and unnecessary chemotherapy, among other complaints.
At the time the case was filed, only two of the eight patients were still living.
The settlement marks the first major legal progress related to the Potti scandal since a judge requested more documents that could be relevant to the medical malpractice lawsuit in late January.
Potti's research was based on a finding that he claimed allowed him to link a patient's cancer to the most effective chemotherapy drug using gene-based models. After he introduced this new method of treatment in 2006, biostatisticians Keith Baggerly and Kevin Coombes at MD Anderson Cancer Center in Houston found several problems with Potti's work and were unable to replicate his results.
As Potti and Nevins continued to publish more papers about the research, Baggerly and Coombes were able to find evidence that pieces of the data involved were falsified to make Potti's results seem more impressive. In 2009, they published their concerns and Duke began investigating three clinical trials that were running based on the research of Potti and Nevins.
Suspicions about the validity of Potti's work grew in 2010 when The Cancer Letter—a national cancer research publication— reported that Potti had falsified information on his resume, leading to an investigation by the Institute of Medicine. Shortly after, Potti and Nevins retracted some of their work and the University canceled the three clinical trials, which involved approximately 100 patients.
Potti took responsibility for the problems and resigned from his positions at Duke’s Institute for Genome Sciences and Policy and the School of Medicine Nov. 19, 2010.
More of Potti's papers were retracted in the following years and an investigation by the Institute of Medicine noted several issues with Duke's handling of the case in a 2012 report.
The case resurfaced in January of this year when The Cancer Letter published a report alleging that Duke professors and deans tried to quiet a whistleblower—former medical student Bradford Perez—who worked in Potti's lab and raised concerns about possible misconduct and falsification of data in Potti's research in 2008.
Update: This article was updated at 9:15 a.m. Sunday to reflect the responses of Henson and Oransky. In an earlier version of the article, The Chronicle incorrectly stated that The News & Observer was the first media outlet to report the news and incorrectly stated that there were more claims still to be decided related to Potti's work. The Chronicle regrets the error.
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