It was a weekend that Michael Cuffe, vice-president for medical affairs at Duke University in Durham, North Carolina, says he will never forget. It began on 16 July 2010, when Cuffe learned of a damning revelation in The Cancer Letter, a Washington DC-based publication with a reputation for probing controversial topics in cancer research. A story in that day's issue alleged that Anil Potti, a cancer geneticist whose data had been used to design three clinical trials then under way at Duke, had lied on multiple federal grant applications, falsely claiming, among other things, to have been a Rhodes scholar.
That was bad news, but for Cuffe and for Sally Kornbluth, Duke's vice-president for research, that was not the worst of it. Months earlier, the same trials had been suspended after critics raised questions about the underlying science. Yet Cuffe and Kornbluth had decided to restart them when a review panel seemed to validate Potti's method. The allegations that Potti, who worked at Duke's Institute for Genome Sciences and Policy (ISGP), had padded his CV changed everything. "When it comes to light that someone may have been less than honest in one aspect of their professional life, one begins to wonder whether they have been less than honest in another aspect," says Kornbluth. That weekend, she and Cuffe suspended the trials once again, and initiated a misconduct investigation that is still ongoing. Potti, who could not be reached for comment, resigned from the ISGP in November and took full responsibility for irregularities in his data.
Now, in response to information obtained by Nature under the US Freedom of Information Act, Kornbluth and Cuffe have offered their account of the mistakes that led the trials to be restarted even after they learned of potential flaws in the underlying data. The affair will have an impact beyond Duke, as the Institute of Medicine, part of the US National Academies in Washington DC, begins to examine research on genome-based patient testing. Originally commissioned to investigate Duke's controversial trials, the institute's US$687,000 study is now expected to focus on providing broader recommendations for the design of clinical trials that similarly use genomic data from individual patients to tailor therapy.
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