Have the flaws in troubled geneticist Anil Potti’s research resulted in a lawsuit against Duke University brought by cancer patients enrolled in clinical trials? The New York Times suggested yesterday that this was the case, which if true would signal the latest adverse turn of events for the North Carolina school, which has been criticized for its handling of the controversy over Potti’s science. However, both Duke and the law firm representing the family of the patient discussed in the Times story denied today to Nature that they are parties to litigation – yet.
The ambiguity over the status of Duke’s legal troubles illustrates the issues that can arise when universities or companies are found to have translated flawed research into the clinic. What constitutes harm to patients, and what legal recourse do they and their families have? Potti, who resigned Duke in 2010 after The Cancer Letter reported that he had fluffed his resume and officials launched a misconduct investigation that critics said was overdue, claimed to develop genomics tests that could predict which of several frontline cancer therapies patients would respond to best. Duke officials have in the past suggested that the more than 100 people enrolled in clinical trials based on the idea were not harmed, since although Potti’s predictive test was flawed, the enrollees were still receiving therapies as good as they would have done otherwise.
But Walter Jacobs, the husband of the patient discussed in the Times story, who died from her cancer after entering the Duke trials, makes clear in a statement to Nature forwarded by his attorney that he does feel harm was done. “When we found out that these clinical trials were based on fraudulent science, and worse that Duke had been repeatedly warned of this by other major cancer researchers but still failed to protect their patients, we were livid. To experiment on patients like this, and in the process to dash their chances of having the best possible outcome, is unforgiveable. ”
Notwithstanding the clear outrage, Jacobs’ attorney Thomas Henson of Henson Fuerst in Raleigh, North Carolina, sounds a cautious note about the prospects for a lawsuit. He says his firm is still investigating the chronology of the case and what Duke’s motivation may have been for continuing trials after outside researchers had issued warnings about them. “In addition, we are analyzing the various potential ways these lung and breast cancer patients may have been harmed, so that once suit is filed we will have done complete due diligence before moving forward in litigation involving such important medical, clinical, and research issues,” he says.
Henson Fuerst is a personal injury firm that has an interesting history with Duke. In 2004 it pursued Duke University Medical Center over tainted surgical instruments allegedly used on thousands of patients. Since January 2011 it has been conducting a campaign to try to recruit patients or families of patients enrolled in the Duke trials and build a case.
Beyond confirming that there is no lawsuit, a spokesman for Duke, Doug Stokke, noted that the university would not comment on litigation matters.
Image: West Campus/ Duke Photography