Dr. Anil Potti, the former Duke University researcher whose work once offered hope for cancer patients, engaged in research misconduct involving six grants, the federal government said Monday, concluding its review of the case.
A notice published in the Federal Register said the government’s Office of Research Integrity had taken final action in the case against Potti, the disgraced doctor who left Duke a few years ago. The government said Potti had “engaged in research misconduct by including false research data” in a number of papers, manuscripts, grant applications and research records.
Potti’s falsified results were published in at least nine of the world’s most prestigious scientific journals, including the New England Journal of Medicine, Nature Medicine, the Journal of the American Medical Association and Lancet Oncology. Those papers were retracted in the fallout from a scandal that brought Duke international attention.
As part of a voluntary settlement with the government, Potti agreed that he would not conduct research without government-approved supervision for the next five years. But he has not engaged in any federal research since 2010, and told the government he had no intention of doing so, according to the notice.
The agreement was struck, the notice said, “to conclude this matter without further expenditure of time, finances, or other resources.” As part of the deal, Potti neither admitted nor denied the office’s finding of research misconduct, and the settlement “is not an admission of liability” by Potti, the notice said.
In May, Duke settled lawsuits with the families of eight cancer patients who participated in clinical trials based on Potti’s phony science.
“Good God,” one of the patients, Joyce Shoffner of Raleigh, said Monday, when learning of the government’s action against Potti. “If you steal a TV you’re going to be a whole lot worse off. ... I think this is pretty dreadful. Five years, what is five years? I’m absolutely disgusted.”
Shoffner, who had Stage 3 breast cancer, said she still has side effects from the wrong chemotherapy given to her in the Duke trial. Her joints were damaged, she said, and she suffered blood clots that prevent her from having knee surgery now. Of the eight patients who sued, Shoffner said, she is one of two survivors.
Potti now works at a cancer center in North Dakota. He did not return a phone call Monday.
Doug Stokke, vice president of marketing and communications at Duke, issued a statement saying the university was pleased with the finding of research misconduct against Potti.
“We trust this will serve to fully absolve the clinicians and researchers who were unwittingly associated with his actions,” the statement said, “and bring closure to others who were affected.”
Ivan Oransky, co-founder of Retraction Watch, an online publication that tracks scientific misconduct, said criminal sanctions are very rare in these kinds of cases. Monday’s notice amounted to a plea bargain in which Potti admitted no wrongdoing, he said.
But, Oransky added, “Realistically his career as a high-profile scientific researcher is over.”
The government’s action may not have much teeth, but the notice does put the misconduct on record. “Certainly a lot of us were thinking this had to be misconduct – it wasn’t just carelessness – but until now, until this official finding, there hasn’t been anyone officially saying fraud,” Oransky said.
Potti’s work was once referred to as the “Holy Grail” of future cancer treatment. In 2006, Potti claimed he had identified genetic markers that would allow customized treatment for patients based on the kinds of tumors they had. It led to clinical trials for patients with lung cancer and breast cancer.
The research garnered positive attention until other scientists couldn’t replicate his results and began to raise questions. The work was halted for a time after Duke hired outside reviewers, who didn’t turn up misconduct.
Then, in 2010, suspicion of Potti intensified when a newsletter called Cancer Letter reported that he had falsely claimed he was a Rhodes Scholar on applications.
Duke’s handling of the entire saga was later called into question when documents in the patients’ lawsuit showed that a medical student had warned Duke administrators about Potti’s research in 2008. The student’s concerns were swept aside.
Shoffner, whose treatment at Duke began in 2008, said she’s disappointed that Potti still treats cancer patients in other states.
“He toyed with our lives,” she said, “and he has gotten by with it. This is nothing – it’s barely a tap on the wrist. I just cannot imagine that this man is allowed to have a medical license.”