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Cancer survivor on bogus Duke study: 'I was nothing but a laboratory rat'

Joyce Shoffner survived a battle with breast cancer perhaps, she said, to share the story of the patients who took part in a clinical trial at Duke University that has been called one of the largest cases of medical fraud in history.

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RALEIGH, N.C. — Joyce Shoffner survived a battle with breast cancer perhaps, she said, to share the story of the patients who took part in a clinical trial at Duke University that has been called one of the largest cases of medical fraud in history.

"I don’t know why I’m still alive. It’s not because of Duke, but by the grace of God I’m still here," Shoffner said Tuesday.

Dr. Anil Potti said he had discovered a way to match a patient's tumor to the best chemotherapy drug, and Duke enrolled patients in three clinical trials related to his research.

Shoffner, now 68 and living in Raleigh, said she was enrolled in a trial within a month of her June 2008 cancer diagnosis.

"It was presented to me in such a way there was no way I could lose," she said. "I went into it with a false sense of confidence that I would most certainly come out of this with no tumor."

Chemotherapy left her hospitalized with blood clots, however, and her tumor continued to grow. After four months, her doctor told her the trial had ended because of "some problems with the data."

"I started immediately going through this trauma and devastation of finding that this was not going to save me and all that I had gone through was for naught," she said.

Duke halted work on the trials in 2010 after learning that Potti had exaggerated his credentials, including claiming that he was a Rhodes scholar.

Two published papers based on Potti's research were retracted after a collaborator said the results of his work couldn't be reproduced, and the American Cancer Society withdrew its funding for his research.

"They never stopped after red flags went up. The flags went up before I ever went into the trial," Shoffner said.

Eight families of trial participants that later sued Duke, Duke University Health System and affiliated physicians, alleging that researchers raised questions about Potti's research as early as 2006. The lawsuit, which was settled last month, alleged that Duke officials tried to cover up questions about the research and performed unnecessary chemotherapy on people in hopes of patenting and spinning off a cancer-screening test.

"It’s enough to be diagnosed with cancer. That’s all you should have to worry about when you have cancer, but on top of it, I’ve had to feel I was betrayed by an institution I revered," said Shoffner, who worked at Duke for decades.

"I feel like, at this point, I was nothing but a laboratory rat," she said. "We were all victims of human experimentation that you don’t expect to be happening in this day and age."

Duke officials declined to comment on the case, and terms of the legal settlement haven't been disclosed. Potti resigned from Duke in late 2010.

Shoffner, one of only two of the eight plaintiffs still alive, blames "fame and money" for the pursuit of the clinical trials in the face of concerns about the underlying research.

"They had the end results set up. They just needed to make everything fit in with it," she said. "Just think about a person’s life. Don’t think about the money you’ll make."

Although she is in remission, her doctors continue to monitor her for any cancer recurrence. She now undergoes treatment at UNC Hospitals.

She said she also has been diagnosed with post-traumatic stress disorder, which she attributes to her experience in the Duke clinical trial, which she now calls "the Potti mess."

"It just affects my everyday life," she said. "It’s always sitting up there on your shoulder."

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