Anil Potti
Anil Potti is a physician and former Duke University associate professor and cancer researcher, focusing on oncogenomics. He, along with Joseph Nevins, are at the center of a research fabrication scandal at Duke University. On 9 November 2015, the Office of Research Integrity found that Potti had engaged in research misconduct. According to Potti's voluntary settlement agreement with ORI, Potti can continue to perform research with the requirement of supervision until year 2020, while he "neither admits nor denies ORI's findings of research misconduct." As of 2024 Potti, who is employed at the Cancer Center of North Dakota, has had 11 of his research publications retracted, one publication has received an expression of concern, and two others have been corrected.
Biography
Anil Potti graduated from Christian Medical College, Vellore, India in 1995. He finished an internship in Internal Medicine at the University of North Dakota School of Medicine in 1999. In 2006 Potti completed training in hematology and oncology at Duke University.Potti resigned from Duke in 2010, following the discovery of flaws in the genomics research conducted at Duke and allegations of embellishments in his resume, assuming responsibility for the anomalies in the scientific research.
Following his resignation from Duke, Potti worked as an oncologist in South Carolina, but was let go in 2012.
Scientific misconduct
According to the Office of Research Integrity, Potti engaged in scientific misconduct while a cancer researcher at both Duke University's Medical Center and School of Medicine. 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.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, 2010 brought further and more widespread scrutiny when it was discovered by Paul Goldberg and reported in The Cancer Letter that Potti had claimed on his curriculum vitae that he had been a "Rhodes Scholar ". He said he was referring to the Association of Rhodes Scholars in Australia Scholarships, an award granted by an organisation of former Rhodes Scholars to bring Commonwealth citizens who attend overseas institutions in to Australia.
Potti's fraudulent research was funded by the US government through the National Institutes of Health; the National Heart, Lung, and Blood Institute; and the National Cancer Institute, in the form of six multi-year grants, and by the Howard Hughes Medical Institute.
60 Minutes described the case as "one of the biggest medical research frauds ever".
University response
Duke University became aware of the suspicions of research misconduct by 2008, when a medical student working with Potti and Nevins withdrew his name from the research and submitted a memorandum entitled "Research Concerns" to the administration. The administration denied any misconduct and convinced the student not to report his experiences to the funding agency, Howard Hughes Medical Institute. Duke later falsely claimed that there had not been a whistleblower involved in the issue.Investigation
The Potti scandal prompted the Institute of Medicine to conduct a study of the proper use of genomics in clinical trials. The Institute of Medicine's report, entitled "Evolution of Translational Omics: Lessons Learned and the Path Forward", was published on 23 March 2012 and made detailed specific recommendations for clinical trials that incorporate "omics". In February 2012, Joseph Nevins stated that it was "abundantly clear" that there was "manipulated data" that could not have occurred by chance. This was confirmed by the 2015 ORI report.Aftermath
Healthcare companies cut ties with Potti after evidence surfaced that Potti had fabricated awards on his resume. The American Cancer Society stopped payments of a five-year grant which totalled $729,000 as Potti had received the grant based on his credentials. Duke University later reimbursed the American Cancer Society for the full amount of the grant.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. The United States Food and Drug Administration reviewed one of the studies in 2009, several years after its initiation, and concluded that the study would require an Investigational New Drug application, which had not been submitted. 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. Potti's medical licence record with the North Carolina Medical Board shows eleven settlements, each of at least $75,000, for incidents that appear to be related to these trials.
In late 2011, the North Carolina Medical Board reprimanded Potti but he retains his medical licence. The board issued its disciplinary action against Potti but imposed no sanctions. In its consent order, the North Carolina Medical Board stated that the board has no evidence from which it could conclude that Potti received funding for medical research as a result of the inaccuracies that he would not have otherwise received, but concluded that "...Potti's conduct as described herein constitutes unprofessional conduct..." In separate action on Potti's medical licence, the North Carolina Medical Board reviewed 11 payments made to settle malpractice claims and posted on its website that "no public action was warranted". Potti was issued a medical licence in Missouri on 1 February 2011; on 6 March 2012, the Missouri medical board issued a reprimand on the basis of actions taken by the North Carolina Medical Board.
In January 2011 Potti applied for a medical licence in South Carolina, which was approved in April 2011. Potti was employed as a practising physician at the Coastal Cancer Center in Loris from March 2011 until 21 February 2012, when he was let go.
In addition to the settlements, two lawsuits also have been filed against Potti, as well as against Duke and other medical personnel there, charging medical negligence among other claims. In his response to the lawsuits, Potti stated that he was "not aware that false or improper data was included in the research."
Robert Califf of Duke testified that they had looked at 40 of Potti's publications and that two-thirds of them would be retracted in whole or in part. Science reported this as "The fallout from the Duke case includes 27 papers that Duke expects to be partially or completely retracted". As of February 2012, ten scientific papers authored by Potti and others have been retracted.
After leaving Duke, Potti hired Online Reputation Manager, a reputation management company, to improve search results for his name.
In February 2013, WordPress received DMCA takedown notices for Retraction Watch blog posts critical of Potti and the posts were removed. Retraction Watch alleges that these DMCA take-down notices were based on false claims. 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. This suit was later withdrawn because the defendant 'neither served an answer nor a motion for summary judgement, and indeed has not appeared'.
Research questions and Institute of Medicine report on 'Omics'
Following questions raised about genomics research that was led by Potti and Nevins at Duke between 2004 and 2010, the National Cancer Institute requested that the Institute of Medicine establish a committee to recommend ways to strengthen omics-based test development and evaluation. 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. The report identified best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. 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.The IOM report further added that "failure by many parties 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." The report specifically called for scientific investigators to make the data, computer codes and computational procedures used to develop their clinical tests "publicly accessible for independent review" and to ensure that their data and research steps are presented comprehensibly. 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. IOM committee chair Gilbert Omenn, a computational biologist at the University of Michigan, said the problems could have been avoided. But he noted, as well, that those kinds of problems were not unique to Duke. "There are a lot of lessons here that surely apply to other places," Omenn said.