The fallout continues from a decision to stop the controversial trials of cancer at Duke University last year: in an article today letter Cancer reports that the US Food and Drug administration (FDA) audit data on the tests. Duke genomics center headed by a researcher on the forefront of cancer, Joseph Nevins, was dissolved, though a Duke spokesman said the decision was already in the works and is unrelated to the audit of the FDA.
There is a long and winding history that goes back several years initial requests from both biostatistician at MD Anderson Cancer Center. They expressed concerns about the science behind genetic predictors of cancer developed by two researchers from Duke oncologist Anil Potti and Nevins. After biostatistician contacted the Duke scientists and newspapers that published their work, Duke began tests based on technology, the use to assign patients to different treatments. In summer 2010, The letter Cancer reported that Potti had padded his resume and claimed he was a Rhodes Scholar when it was not. He resigned, and the tests were discontinued. Several documents describing the technology have recently been retracted.
But the story is not over. Letter Cancer has published a series of documents, including some that reflect the uncertainty about the role of the FDA in regulating these technologies, which use patterns of genes in tumors predict how a patient will fare.
The Institute of Medicine, meanwhile, held a series of meetings to discuss how technologies such as these are used in clinical trials.
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