FRAUD HAPPENS EVERYWHERE

Last week, Anil Potti, MD, a former star cancer researcher at Duke University, was found by federal investigators to have "engaged in research misconduct" by including "false research data" in multiple published studies and other documents. He received a 5-year ban from federal grant funding as punishment.

However, the research in the published studies was undertaken by a team of investigators at Duke, including other clinicians, statisticians, and scientists. Various findings led, in turn, to large clinical trials that involved hundreds of patients and subsequent collaboration with other researchers. Is it fair that only one person should take all the blame?

And what is the institutional responsibility of Duke University, which had apparently been warned about research irregularities by a whistleblower in 2008?

These and other questions remain about the case, which is a scandal, say a pair of cancer research experts writing in a guest editorial published online November 13 in The Cancer Letter, a trade publication.

"A case with millions of taxpayer dollars misused, totally fabricated research, damage to hundreds of patients recruited for treatment with 'the holy grail' of cancer treatment, and a pathetic institutional response is being closed with a 5-year funding ban for one investigator, individually and alone," write editorialists Keith Baggerly, PhD, a biostatistician at the University of Texas M.D. Anderson Cancer Center in Houston, and C.K. Gunsalus, an expert in scientific misconduct at the University of Illinois at Urbana-Champaign.

The pair point out that, because of clinical trials associated with faked genomics data and flawed technical approaches, Dr Potti "put patients at risk" repeatedly from 2005 to 2010. Some patients subsequently filed lawsuits against Dr Potti and Duke, claiming that they had participated under false pretences in a "fraudulent clinical trial."

As previously reported by Medscape Medical News, the Duke research led to studies (later retracted) that reported advances in the use of genomics to predict cancer treatment responses, cancer recurrence, and other clinical events. The studies appeared from 2006 to 2009 in prestigious major medical journals, including the New England Journal of Medicine, JAMA, the Journal of Clinical Oncology, and the Lancet Oncology.

Some of the research led to clinical trials funded by the National Cancer Institute (NIH) that put patients at risk for harm and were eventually discontinued.

Dr Potti's Punishment Questioned

Notably, Dr Potti did not admit to having committed fraud to investigators from the US Office of Research Integrity (ORI).

Instead, he entered into a "voluntary settlement agreement" and "neither admits nor denies the ORI findings of research misconduct," according to an ORI report published online November 9 in the Federal Register. The report is the "final action" in the 5-year investigation.

Despite the grand scope of the faked research, no one else at Duke was reviewed or cited by federal investigators in last week's report.

Duke issued a statement last week that suggested that other Duke staff were duped by him.

"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," said Doug Stokke, vice president of marketing and communications for Duke Medicine.

However, the Cancer Letter editorialists have damning words for Duke about the handling of the protracted scandal.

"This case is about as serious as one can imagine at the individual level. At the institutional level, it is beyond disappointing at every turn: in handing an internal whistleblower; in responding to credible, serious, and repeated external scientific queries; in managing the multiple conflicts of interest in the situation; in limiting the information available to an interim scientific review; in how its leaders testified to an IOM review committee; in its legal responses," the pair write.

The whistleblower was a third-year medical student who warned university officials about Dr Potti's misconduct in 2008. However, that student, Bradford Perez, was effectively silenced by school officials and researchers, as detailed in a report in the Cancer Letter earlier this year.

The editorialists think that Dr Potti got off too lightly. "Potti's behavior was egregious and warrants more severe punishment than just a 5-year ban on NIH funding," they note.

As troubling as Dr Potti's actions were, Duke's were worse, they argue.

"Even more worrisome than the extensive and persistent behavior of one investigator is the institutional oversight of the research and patient treatment," they write.

Duke could have acted much more quickly — by 2 years, argue Dr Baggerly and Gunsalus. "There is extensive documentation that multiple Duke administrators received credible information about serious problems in the Nevins/Potti lab as much as 2 years before they finally acted in 2010," they write, referring to Joseph Nevins, PhD, the Duke researcher who was Dr Potti's mentor.

The fraud committed by Dr Potti was "blatant" and was detectable upon careful review, say the editorialists. And they add that Dr Potti unlikely acted alone, saying there is an "implausibility" about that.

The pair would like a full accounting of who else was involved. "It's hard to tell how those around Potti — cast here as a sole and only bad apple — have been 'absolved.' Who, exactly, is on that roster? Who were the witting?" they ask.

They also observe that Duke did not take any action against Dr Potti until 2013, right after the Cancer Letter exposed Dr Potti for padding his resume. Among other accomplishments, he claimed to be a Rhodes Scholar. He was not. He was then fired by Duke.

Dr Potti is now working at a cancer center in Grand Forks, North Dakota, according to a report in Retraction Watch.