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Possible Harm to Patients Looked at

Possible harm to patients looked at [The Herald-Sun, Durham, N.C.]

From Herald-Sun (Durham, NC) (February 3, 2011)

Feb. 03--DURHAM -- A Raleigh-based personal injury law firm says it’s investigating whether potential legal action could be brought against Duke University for clinical trials based on the work of a now-discredited researcher.

"We have been receiving numerous calls from patients and family members who feel frightened, vulnerable and at a loss to know where else to turn for help," said Thomas Henson Jr., an attorney with the firm of HensonFuerst. "We are currently in the initial stages of our investigation which will allow us to determine what legal action can or should be taken on behalf of these patients."

More than 100 local residents were enrolled in three clinical trials that were based on work by Anil Potti, who resigned under fire from the Duke faculty in November.

The cancer researcher had been under investigation since last summer, when reports first arose that he had embellished his resume, including falsely claiming to be a Rhodes Scholar. Questions also had surfaced about the scientific integrity of Potti’s work, including criticism from two Texas-based researchers who claimed that the Duke scientist’s conclusions couldn’t be reproduced.

A university review confirmed that Potti had indeed inflated his credentials, at least two papers he had authored have been retracted, one of his most prominent collaborators has acknowledged that the results of the work could not be reproduced and Duke has had to return funding granted for his research.

The clinical trials based on the research -- which focused on how physicians can use information about a patient’s genetic makeup to decide the best tactics for treating cancer -- were first suspended and then terminated. Michael Cuffe, the Duke University Health System vice president for medical affairs, acknowledged last fall that "in retrospect, these trials should not have been done."

Henson said his firm, which represented more than 100 patients who had been exposed to waste hydraulic fluid during surgery at two Duke facilities in 2004, said the clinical trial participants "first and foremost" want answers.

Among many questions they have, he said, they want to know what is "the potential harm to patients as a result of their involvement in a clinical trial based on flawed science."

They are "questioning why patient protection and the integrity of human subjects was not the foremost concern as these trials were considered as an option and then progressed," Henson said.

The lawyer added that the participants also want to know why Duke may not be disclosing all it knows to the patients.

"The letters our clients have received have had no significant detail which would answer concerns you would expect patients to have," he said. "The letter basically says that Duke became aware that these studies were based on bad science, but don’t worry, there was no harm. This doesn’t serve to allay the fears of those who were funneled to these fraudulent trials."

Meanwhile, The Cancer Letter, the journal that first disclosed that Potti had fudged his credentials, reported last week that the U.S. Food and Drug Administration is auditing data related to the trials.

There are still two ongoing investigations of Potti’s work, a formal Duke inquiry into whether there had been any scientific misconduct and an outside review of his research by the national Institute of Medicine.

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Posted: February 2011