Cancer patients were enrolled in “fraudulent” research, US lawsuit allegesBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5986 (Published 21 September 2011) Cite this as: BMJ 2011;343:d5986
Duke University, in North Carolina, is facing two lawsuits alleging that patients with cancer were exposed to unnecessary and harmful chemotherapy after being enrolled in “fraudulent” clinical trials that were based on flawed research.
The trials, which have been discontinued, were based on research by the oncologist Anil Potti into a technique that uses gene expression to predict which chemotherapy would be best for an individual patient with lung or breast cancer.
Dr Potti has resigned and six of his research articles—in the New England Journal of Medicine, Nature Medicine, Lancet Oncology, the Journal of Clinical Oncology, Blood, and PLoS One—have been retracted in recent months.
Robert Califf, Duke University’s vice chancellor for clinical research, told a public meeting of the US Institute of Medicine on 22 August that the university had nearly completed a review of Dr Potti’s research there. Of 40 papers, he said, about a third were expected to be retracted in full and another third in part.
“In those retractions and partial retractions there is a clear correlation between the need to withdraw the data and the extent to which the data originated from Dr Potti,” he added.
Duke and Dr Potti had stakes in a company, CancerGuide Diagnostics, which is being sued along with the university. The lawsuits, filed on behalf of seven participants in a lung cancer trial and one patient with breast cancer—accuse the defendants of knowingly engaging in “a plan to generate billions of dollars in revenue” and “falsely claiming that the delivery of chemotherapy agents to human subjects was based on valid science when they knew it was not.”
Questions about the data were first raised by Keith Baggerly and Kevin Coombes, biostatisticians at the University of Texas M D Anderson Cancer Center in Houston. Despite these concerns Dr Potti and his mentor, the cancer geneticist Joseph Nevins, launched three clinical trials that were based on the work.
Plans to launch another trial of lung cancer treatment using the same principles, funded by the National Cancer Institute, prompted a biostatistician of the institute, Lisa McShane, to try to replicate the work. When she was unable to do so she contacted administrators at Duke.
Duke suspended the trials and set up an external review in October 2009. But the reviewers did not have access to the full extent of the concerns of the National Cancer Institute or the Anderson Cancer Center and recommended that the trials should resume. Duke began enrolling patients again in February 2010.
In July 2010 the Cancer Letter, a weekly subscription newsletter that reports on “current and controversial topics in oncology,” reported that Dr Potti had lied in grant applications and other documents, including falsely claiming to be a Rhodes scholar. Duke halted the trials and began the investigation leading to the retractions.
Together with the National Cancer Institute, Duke has asked a committee of the Institute of Medicine to look at why the university took so long to realise that the data were flawed and to suggest what lessons should be learnt for the future. Duke administrators have told the committee that at the time they set up the external review they regarded the issue as involving a scientific dispute and patient safety rather than possible research misconduct.
Cite this as: BMJ 2011;343:d5986