Duke sued over clinical trials

September 8, 2011 2:37:41 PM PDT
A lawsuit filed in Durham Superior Court names Duke University, Duke University Heath System, and five doctors. It accuses them of participation in a fraudulent clinical trial and exposing patients to unnecessary treatment - including chemotherapy.

Click here to read the lawsuit (.pdf)

One of the eight plaintiffs is the estate of Juliet Jacobs of Orange County. She was diagnosed with stage IV lung cancer in 2009, and in early 2010, lawyers say she was recruited by Duke to participate in the clinical trial. As a result, the lawsuit claims she suffered mental and physical harm.

The lawsuit alleges the clinical trial relied on the work of former Duke cancer researcher Anil Potti. In 2006, he and colleagues published an article that claimed they had developed a test that could predict which lung cancer patients would benefit from chemotherapy.

But two doctors in Texas reported they could not replicate the results of the study, and the lawsuit filed Wednesday alleges they warned Potti and Duke on multiple occasions about their concerns. Lawyers claim Duke failed to respond.

Clinical trials began in 2007 and 2008. They were suspended briefly in 2009 while an internal review board looked at certain questions. The lawsuit also alleges Duke withheld information from that board.

The clinical trials resumed.

Then in 2010, it came to light that Potti had padded his resume, falsely claiming he was a Rhodes Scholar, and that he made the same claim on grant application. He resigned from Duke and several of his articles have been retracted by medical journals. The clinical trials were also stopped.

"Duke conducted clinical trials on cancer patients that should never have occurred. The trials were based on bad science. Researchers across the country had been telling Duke and warning Duke about the bad science," said plaintiff's attorney Thomas Henson.

Of the eight plaintiffs names in the lawsuit, only two are still living,

Contacted by ABC 11 Thursday, Duke said it couldn't comment on active litigation, but spokesperson Sarah Avery said the university is actively investigating Potti's research and possible misconduct.

The ABC11 I-Team discovered this week that Potti is still practicing medicine. He's working at The Coastal Cancer Center in Myrtle Beach, South Carolina. It's a facility that conducts clinical trials.

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