More Trouble for Duke as FDA Audits Center, The Cancer Letter Reports
The fallout continues from a decision to halt controversial cancer trials at Duke University last year: In an article today, The Cancer Letter is reporting that the U.S. Food and Drug Administration (FDA) is auditing data related to the trials. The Duke genomics center run by a prominent cancer researcher, Joseph Nevins, has been disbanded, although a Duke spokesperson says that decision was already in the works and is unrelated to the FDA audit.
It's a long and winding story that dates back several years to initial queries from two biostatisticians at MD Anderson Cancer Center. They expressed concerns about the science behind genetic cancer predictors developed by two Duke researchers, oncologist Anil Potti and Nevins. After the biostatisticians contacted the Duke scientists and the journals that published their work, Duke launched trials based on the technology, using it to assign patients to different treatments. In the summer of 2010, The Cancer Letter reported that Potti had padded his resumé and claimed he was a Rhodes scholar when he wasn't. He resigned, and the trials were halted. Several papers describing the technology have recently been retracted.
But the story isn't over. The Cancer Letter has released a raft of documents, including some that reflect uncertainty over FDA's role in regulating these technologies, which use gene patterns in tumors to predict how a patient will fare.
The Institute of Medicine, meanwhile, is holding a series of meetings to discuss how technologies like these are used in clinical trials.