He resigned in November 2010 after Duke put him on administrative leave, terminated the clinical trials based on his research and retracted his published data.
[9][11][12] Potti and his team were accused of falsifying data regarding the use of microarray genetic analysis for personalised cancer treatment, which was published in various prestigious scientific journals.
While there were questions concerning Potti's work beginning in 2007, notably from two bioinformatic statisticians, Keith Baggerly and Kevin Coombes at MD Anderson Cancer Center,[13][14] 2010 brought further and more widespread scrutiny when it was discovered by Paul Goldberg and reported in The Cancer Letter[15][16] that Potti had claimed on his curriculum vitae that he had been a "Rhodes Scholar (Australian Board)".
The administration denied any misconduct and convinced the student not to report his experiences to the funding agency, Howard Hughes Medical Institute.
[30] Three clinical trials at Duke University Medical Center based on Potti's research came under scrutiny in 2009 and were temporarily suspended, then were permanently stopped in 2010.
[33] An FDA audit in 2011 further showed that an Investigational Device Exemption application had not been filed, but otherwise found "no significant deficiencies" in Duke's IRB conduct.
[54] In November 2013, Automattic, provider of the WordPress webhost service that hosts Retraction Watch, filed suit against the filer of the takedown notice, saying that he had made those false claims in violation of the DMCA.
The IOM's recommendations released in March 2012 spoke to the many parties responsible for discovery and development of omics-based tests, including investigators, their institutions, sponsors of research, the FDA, and journals.
[27][57] The IOM's recommendations aimed to ensure that progress in omics test development is grounded in sound scientific practice and is reproducible, resulting not only in improved health care but also in continued public trust.
[27][57] The IOM report further added that "failure by many parties [at Duke] to detect or act on problems with key data and computational methods … led to the inappropriate enrollment of patients in clinical trials, premature launch of companies and retraction of dozens of research papers.
[27][57] The report also found that so-called "omics" tests – such as genomics and proteomics, which are diagnostic tools based on molecular patterns – are in general highly prone to errors.