Updated: Anil Potti, Duke Cancer Researcher Accused of Misconduct, Resigns

Updated 6:30 p.m. with comments from Dr. Anil Potti, IGSP Director Huntington Willard and Dr. Michael Cuffe, DUHS vice president for medical affairs.

The Duke cancer researcher who has been under investigation for research misconduct since this summer has resigned.

Anil Potti

Dr. Anil Potti stepped down from his positions at Duke’s Institute for Genome Sciences and Policy and the School of Medicine Friday and took sole responsibility for the problems in his research, IGSP Director Huntington Willard said. Potti had been on paid administrative leave since this summer.

“This is obviously a very regrettable series of events at all kinds of levels,” Willard said in an interview Friday.

Potti’s resignation comes after the termination of clinical trials based on his research and the retraction of a key paper he authored. The terminations and retractions occurred because Duke no longer had confidence in the research underlying them. In resigning, Potti took responsibility for the problems that undermined this research.

In an e-mail, Potti did not discuss details of his resignation.

“It has been a difficult time, as you might imagine,” he wrote.

He said Willard’s message to IGSP staff “summarized things well.”

“[Potti] accepted full responsibility for a series of anomalies in data handling, analysis and management that have come under scrutiny in the past months,” Willard wrote in an e-mail to IGSP staff.

Moving forward

Potti chose to resign, Willard said, so that other researchers at IGSP could move forward with their work.

“He came to a realization that he wasn’t going to be a part of that future,” Willard said. “Once he reached that conclusion, then resigning was the obvious thing to do.”

Willard noted that Potti’s resignation was not an admission of research misconduct. Both Duke University Health System and Institute of Medicine investigations into Potti’s research are ongoing, officials at the institutions said.

“We still have a lot of work to do as a university and as a medical center to bring this investigation around research misconduct and the other elements forward, whether he’s here or not,” said Dr. Michael Cuffe, DUHS vice president for medical affairs. “Our focus is on the patients, it’s on the review of this foundational science and any retractions that are necessary.”

“These trials should not have been done”

Three clinical trials based on Potti’s research were terminated earlier this month due to questions about the underlying research. The cancer treatment trials had been suspended this summer after allegations that Potti falsified portions of his resume led to scrutiny of his research.

“In retrospect, these trials should not have been done,” Cuffe said.

He said he does not think patients were harmed in the trials, because all were provided with standard of care cancer treatments. Still, he said he will ask the researchers responsible for running the trials whether they have any concerns about patient safety.

Duke also informed the patients, their families and their doctors about the clinical trial problems, he said. He told the physicians to discuss any other cancer treatments that the patients might want to pursue.

Cuffe said he does not yet know whether Duke will need to repay any of the funding it received to run these trials.

“Investigators set up the trials in partnership with the sponsors with the best of intentions,” he said. “I would hope that that would be noted.”

Examining the research

Willard said IGSP researchers have been examining Potti’s work to determine whether his papers need to be withdrawn.

Dr. Joseph Nevins, Potti’s mentor and collaborator, has asked Nature Medicine to retract a paper Potti coauthored in that journal, Willard said.

A paper authored by Potti and others was retracted from the Journal of Clinical Oncology this week, after Nevins requested that it be withdrawn.

The two papers were important contributions to the study of using genetic information to target cancer treatments, and Willard said it is too soon to be sure how the field at large will be affected by the retractions.

“My hope is that this will, in the fullness of time, be seen as a very modest setback, that the field will continue to thrive and move forward,” Willard said. “The concept behind the science is completely solid.”

Cuffe said some of the funding for Potti’s research may need to be returned to the organizations that provided it.

“In terms of work that Potti did with foundations, with federal grants and the rest, we will work with those sponsors to understand their views,” he said. “Of course, some funds may need to be repaid.”

Dr. Otis Brawley, chief medical officer of the American Cancer Society, said ACS is still investigating whether Potti fraudulently obtained a $729,000 grant from the society. But he said the resignation and retractions have “no effect whatsoever” on how the organization will conduct its review.

He noted that ACS needs further information about why Potti resigned and why the papers were retracted.

Brawley said the University will not be prevented from receiving future funding from ACS assuming that it adequately resolves the issue.

“If Duke behaves the way I expect Duke to behave it will not affect our relationship,” he said. “But as I said before, it is really up to Duke to look into this and really make it right.”

Investigations continue

Potti’s resignation comes four months after Duke began reviews of the doctor’s work and credentials and placed him on paid administrative leave. Those investigations started after The Cancer Letter reported that Potti had falsified portions of his resume.

At the end of August, Duke announced that an investigation into Potti’s credentials found “issues of substantial concern.” The research misconduct investigation is ongoing as is a separate Institute of Medicine examination of Potti’s work and some related issues.

The IOM review focuses on the “scientific underpinnings” of the trials and Potti’s resignation will not affect it, said Christine Stencel, media relations officer for the IOM. The IOM is expected to complete its study and produce a report by 2012.

Sonia Havele contributed reporting.

Click here to read the e-mail Willard sent to IGSP staff Friday.

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