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Data fraud leads to multimillion-dollar settlement

Duke University agrees to pay US$112.5 million in case of researcher charged with systematic data fraud

Zansky

Duke University in the USA has reached an agreement with the courts to pay US$112.5 million to settle a lawsuit in which a researcher from the institution was accused of falsifying data in scientific articles and funding applications submitted to federal agencies, including the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA).

Erin Potts-Kant, a former clinical research coordinator at the pulmonary division of the university’s health system, which encompasses its member hospitals, school of medicine, and school of nursing, was responsible for certifying the validity of research results, but instead changed unfavorable data to help obtain or maintain funding. Studies on the lung function of mice, which were based on manipulated data, were awarded a total of US$200 million in federal funding between 2006 and 2018. Twelve scientific articles were also retracted for using manipulated data. The researcher was named as coauthor on dozens of scientific papers that are now being investigated. “Potts-Kant engaged in systematic research fraud,” stated a lawsuit filed by former Duke University laboratory analyst Joseph Thomas, who sued the institution in partnership with the United States Justice Department. According to Thomas, Potts-Kant went as far as inventing entire data sets.

The scandal drew attention not only because of the amount of money involved, but also due to the use of legislation rarely applied in cases of scientific integrity: the False Claims Act, which makes those who commit fraud involving federal funds liable for substantial damages, up to as much as three times the diverted or illegally obtained money. Most of the US$112.5 million will go to the agencies that funded projects as a result of falsified data. The law also allows whistleblowers to receive up to 30% of the amount paid in compensation. In this case, the suit was brought by Joseph Thomas, who will receive US$33.75 million. “This settlement sends a strong message that fraud and dishonesty will not be tolerated in the research funding process,” the Justice Department said in a statement.

We must accept responsibility and acknowledge that our processes did not work, said Dean Vincent E. Price

Potts-Kant, who also faced charges of diverting money from the institution, was dismissed by Duke in 2013 when the case first surfaced, but this was not enough to reverse the damage to the university’s reputation after a number of other scandals. Duke is one of the most prestigious universities in the USA—it has an annual research budget of US$1 billion and is associated with 13 Nobel laureates. But it has faced other allegations of misconduct in the past. In the mid-2000s, two Duke researchers, Anil Potti and Joseph Nevins, selected patients for clinical trials of methods potentially capable of predicting the progress of certain types of cancer and suggesting the most appropriate treatment. Participants were recruited despite the fact that errors had been identified in the scientific research behind the techniques. Undeterred by evidence of these problems, the university authorized the trials in February 2010, based on explanations from Potti that later turned out to be inconsistent. Both researchers were fired.

The institution’s handling of the case was cited as an example of poor oversight in a comprehensive report published by the National Academies of Science, Engineering, and Medicine in April 2017, which included recommendations on how to improve scientific integrity practices and policies in the US. “I don’t know if Duke has changed its practices, but it wouldn’t surprise me if it happened again,” said bioengineer Robert Nerem, chair of the committee that produced the report.

In the case of Potts-Kant, the university was accused of not monitoring the work of its researchers closely enough and being slow to take action when the case broke. As a result, the NIH has imposed additional restrictions on Duke researchers since 2018. Projects with funding of US$250,000 or more must provide more detailed budgets than those required from other institutions.

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The university issued an official statement defending its actions, claiming it only discovered the potential fraud in 2013, after Potts-Kant was fired. It also admitted that did it not initially understand the gravity and extent of the crime. The university’s president, political scientist Vincent E. Price, said the institution is reviewing its scientific integrity processes. “We expect Duke researchers to adhere always to the highest standards of integrity, and virtually all of them do that with great dedication,” he said. “When individuals fail to uphold those standards, and those who are aware of possible wrongdoing fail to report it, as happened in this case, we must accept responsibility, acknowledge that our processes for identifying and preventing misconduct did not work, and take steps to improve.”

Last year, the university appointed gynecologist Geeta Swamy to the newly created position of vice dean for scientific integrity. It also opened an Office of Scientific Integrity and began demanding detailed plans and accounts from all Duke Health units. Price also recently announced the formation of an Advisory Panel on Research Integrity and Excellence, which will recommend new policies by June 30, and an Executive Oversight Committee headed by A. Eugene Washington, chancellor for health affairs. “We continue to have great confidence in the high quality of Duke faculty and their research,” Price said.

“This settlement, which results primarily from willful misconduct that took place in one laboratory, but which affected the work of many more researchers, should not diminish the life-changing and life-saving work that takes place every day at Duke University.”

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