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Duke lands in court over flawed clinical trials

West_campus32.jpgTwo cancer patients and six families of deceased patients who had enrolled in clinical trials based on geneticist Anil Potti’s allegedly flawed data are suing the beleaguered researcher, one of his collaborators, Duke University (his former employer) and several Duke officials.=

Potti had claimed a link between gene expression profiles and responsiveness to particular drugs, which was used to set up trials in which patients were allocated to treatments depending on their expression profiles. Five of his papers have been retracted and an investigation into flaws in his data is ongoing.

Patient attorney Thomas Henson of HensonFuerst in Raleigh, North Carolina, told Nature in July that the firm was still working to understand how around 100 patients enrolled by Duke might have suffered harm as a result of Potti’s actions — and actions by Duke in continuing the trials after concerns were first raised about his research, before later halting them.

Now, the firm is making its case. A complaint filed on 7 September in Durham County Superior Court in North Carolina alleges that patients enrolled in the trials as a result of misrepresentations by Potti did not give proper informed consent, were subjected to unnecessary biopsies to assess their suitability for the trials, and were allocated treatments different from the standard as a result of their enrollment.

Duke has claimed that all the treatments received by patients were standard and that the flawed gene expression formula was used only to allocate them to one arm or another. The University has said it will not comment on the litigation.

Image: West Campus / Duke Photography


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