September 13, 2011 — The saga of former Duke University cancer researcher Anil Potti, MD, continues. Eight patients (or their estates) who participated in the clinical trials conducted by Dr. Potti and colleagues are now suing him and the university.
A lawsuit was filed in Durham Superior Court in North Carolina. The suit names as defendants Duke University, Duke University Heath System, 5 researchers (including Dr. Potti and his collaborator Joseph Nevins, PhD), and CancerGuide Diagnostics (in which both Dr. Potti and Dr. Nevins had an interest). In the lawsuit, filed on September 7, the plaintiffs assert that they participated under false pretence in a "fraudulent clinical trial" and were exposed to improper and unnecessary chemotherapy and treatment. In addition, the treatment regimens were based on falsified medical research.
As previously reported by Medscape Medical News, the story of Dr. Potti has been complicated and tumultuous, involving not only concerns about the validity of his research, but also allegations of misconduct.
Misconduct and Errors
Dr. Potti, an oncologist and genomics researcher, was forced to retract 5 papers from prestigious peer-reviewed journals because of results that could not be reproduced.
In July 2010, Duke began investigating Dr. Potti's work and credentials and placed him on paid administrative leave after the publication of an article in The Cancer Letter, which reported that he overstated his academic achievements by claiming to be a Rhodes Scholar. He resigned from his positions at the Duke University School of Medicine and the Duke Institute for Genome Science and Policy in November 2010.
The research conducted by Dr. Potti and colleagues was directed at developing gene-expression signatures that predict responses to various cytotoxic chemotherapeutic drugs. The goal of this research was to identify characteristics of individual patients that could be matched with specific therapeutic agents. His published papers reported that the signatures identified in his lab had the capacity to predict therapeutic response; when first reported, his work was enthusiastically welcomed by the oncology community.
This research led to the initiation of several large clinical trials sponsored by the National Cancer Institute, which were halted when questions about the reproducibility of the results were raised.
Keith Baggerley, PhD, and Kevin Coombes, PhD, biostatisticians at the University of Texas M.D. Anderson Cancer Center in Houston, attempted to verify the results but found a series of errors, including the mislabeling and mismatching of the gene probe identifiers. Their findings were published in November 2009 in the Annals of Applied Statistics (2009;3:1309-1334), and they concluded that, "unfortunately, poor documentation can shift from an inconvenience to an active danger when it obscures not just methods but errors."
The 2 biostatisticians also suggested that the errors they found in the technology were being replicated in ongoing clinical trials to allocate patients to treatment groups, and might be putting the patients at risk.
Questionable Scientific Research
The lawsuit notes that Dr. Baggerley and Dr. Coombes had been publicly raising concerns over errors in the research since 2006, but that Duke University chose to continue the trials. Throughout 2009 and 2010, the 2 biostatisticians had issued a warning to both Dr. Potti and Dr. Nevins and to Duke, either directly or in their published work, that the clinical trials were based on "questionable scientific research."
It also points out that Duke University "breached their ethical, moral, and 'responsible party' duties" when they failed to properly examine Dr. Potti's credentials, failed to exercise basic oversight, failed to put patient's needs and medical care issues above financial incentives, failed to perform computational calculations that would have revealed that their researchers' data had serious errors and issues prior to the initiation of clinical trials, and failed to timely terminate — rather than suspend — the clinical trials once the gross errors and problems underlying the research came to light.
Duke conducted clinical trials on cancer patients that should never have occurred.
In an interview with a Raleigh–Durham television station, the plaintiff's attorney, Thomas Henson, said that "Duke conducted clinical trials on cancer patients that should never have occurred. The trials were based on bad science. Researchers across the country had been telling Duke and warning Duke about the bad science."
According to the report, Duke was contacted for a comment but the university said they were unable to comment on active litigation. However, a Duke spokesperson stated that the university was actively investigating Dr. Potti's research and possible misconduct.
Of the 8 plaintiffs named in the lawsuit, only 2 are still alive.
Dr. Potti is currently employed by the Coastal Cancer Center, a facility that conducts clinical trials.
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Cite this: Dr. Potti and Duke University Sued Over Faulty Research - Medscape - Sep 13, 2011.