It has been just over a year since Duke University officials appeared before the Institute of Medicine’s Committee to Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials.
At the time, Robert Califf, MD, Vice Chancellor for Clinical Research at Duke, and other officials predicted that the misconduct investigation looking into the actions of Anil Potti, MD, (discussed here and here; summarized in the IOM report here) would be completed by the end of 2011. A few months later, we were told it would be early in 2012.
Here it is the end of August and we still haven’t heard.
When I asked Duke about the delay, I received two responses. First from an official spokesperson, who provided the following statement:
“Everything possible is being done to expedite this misconduct investigation despite the complexities involved and the federal requirements for such a process. According to the federal Office of Research Integrity [ORI], in 2010, the average misconduct investigation process by an institution (assessment, inquiry and investigation) was 19 months in duration with a range of 1 month to almost 4 years. ORI's portion, which follows the institutional process, averaged 7.2 months, with a range of 1 month to more than 4 years.”
Dr. Califf also responded via email to my queries. “…this is now in the hands of the misconduct committee and associated lawyers. ORI granted an extension to the committee till the end of September.”
Dr. Califf noted that ORI can accept, reject, or ask for revisions on the findings of the institutional investigation. And that it is the agency’s decision whether the results of the investigation will be made public.
Given the impact of the past events on patient care, I sincerely hope ORI will make the results known.
When asked directly, ORI said they cannot discuss the case at this time.
So here we are, waiting -- and hoping that the officials at each level do the right thing: Conduct a thorough investigation and provide answers to the many questions raised during the IOM discussions and by other researchers.
In the meantime, according to Dr. Califf, Duke is putting “resources into quality initiatives that have been very helpful.”
For Potti, the latest news, according to a report in the Grand Forks Herald, is that he is working as an oncologist at the Cancer Center of North Dakota. The Herald article quotes his new boss, William Noyes, MD, MBA, as saying that the problematic work at Duke “did not involve patient care, but clinical trials, which the Cancer Center does not do.”
Uhm, excuse me if I’m being dense, but since when did clinical trials and patient care become two exclusive domains?