Durham County

Duke University settles suit with cancer patients over clinical trials

Duke University has settled the lawsuit filed by the families of eight cancer patients treated in clinical trials based on bogus science, a Duke spokesman said Saturday.

The settlement ends another chapter in the long-running scandal over research conducted by Dr. Anil Potti, once a rising scientist who has retracted 11 research papers and left Duke in disgrace in 2011.

Duke spokesman Michael Schoenfeld declined to discuss the amount of settlement or any other questions about the lawsuit.

But the dollar amount of the settlement is likely to be substantial, given the depth of the research misconduct and damaging evidence discovered in the lawsuit, including a whistleblower who alerted Duke to the misconduct in 2008 but went ignored.

Duke officials shut down the trials in 2010 and flatly said they should never have been done.

The investigative TV news show “60 Minutes” said the case could go down in history as one of the biggest medical research frauds ever.

Ivan Oransky, a founder of Retraction Watch, a website devoted to retractions and scientific misconduct, said that although he was uncomfortable calling any case the biggest ever, the Potti case was extremely serious.

“This is a case that captures the public imagination, involving all the issues one is concerned about in scientific misconduct,” Oransky said. “There are millions of dollars in federal funding at a prestigious research university involving real people, not just mice or cell lines.”

Patient lawsuit

Eight patients – or their estates, since some have died from their illnesses – sued Duke, Potti, his mentor and research collaborator Dr. Joseph Nevins and Duke administrators. The settlement covered all the defendants, Schoenfeld said.

Nevins, now retired, had to retract the work in prestigious peer-reviewed scientific journals, including the Journal of Clinical Oncology and Nature Medicine. His lab at Duke reaped millions of dollars in federal and private research grants

The lawsuit alleged that the scientists engaged in a systematic plan to commercially develop cancer tests worth billions of dollars while using science that they knew or should have known to be fraudulent.

In 2006 Potti reported that he found genetic markers in tumors that could predict which cancer patients might respond well to certain forms of cancer therapy. The discovery, which one senior Duke administrator later said would have been a sort of Holy Grail of cancer research if it had been accurate, electrified other scientists.

Beginning in 2007, three clinical trials tested the approach by enrolling more than 100 lung and breast cancer patients, and were expected to enroll hundreds more.

But researchers elsewhere couldn’t reproduce their results and quickly began to raise questions. In particular, two biostatisticians at MD Anderson Cancer Center in Houston, Keith Baggerly and Kevin Coombes, brought problems to the attention of Duke officials and began questioning the research publicly.

In 2009 Duke suspended the enrollment of new patients and commissioned an outside review. But the reviewers reported that Potti’s work seemed fine, and Duke rebooted the trials. University leaders later said those reviewers hadn’t looked at the basic data Potti had used.

The case blew up after the Cancer Letter, a newsletter that had been following the case closely, reported in July 2010 that Potti had falsely claimed to be a Rhodes Scholar in grant applications and elsewhere. Duke ended the studies.

The lawsuit turned up documents showing that a medical student raised concerns about Potti’s misconduct in 2008, just after the clinical trials were getting off the ground and two years before the trials were stopped. Duke officials had previously said they received no whistleblower reports.

The whistleblower, Brad Perez, is now finishing up a medical residency at Duke. In a January email with The News & Observer, Perez said he quit working with Potti and notified higher-ups, even though that decision cost him an extra year in medical school.

“In the course of my work in the Potti lab, I discovered what I perceived to be problems in the predictor models that made it difficult for me to continue working in that environment,” he wrote. “I raised my concerns with my laboratory peers, laboratory supervisors and medical school administrators.”

Outside scientists who raised questions about the research said they were most worried about the prospect that patients were being put at risk by their participation in the clinical trials. They said the unproven genetic analysis could result in patients being prescribed an improper treatment.

Duke has maintained, though, that the patients received proper care.

Thomas Henson, lawyer for the plaintiffs, could not be reached to comment Saturday.

Potti is now working at a cancer center in North Dakota.

Neff: 919-829-4516