Durham, NC -  

I felt it important to provide you with an update on our actions in response to allegations regarding Dr. Potti and to a letter that we, and others, received from a group of nationally respected statisticians concerning the status of the clinical trials based on the science conducted by Drs. Potti and Nevins.

I would note that the actions we have taken to address this situation have been guided foremost by concern for the well-being of our patients, as well as an institutional commitment to integrity, accountability and simply doing the right things. Upon learning of the CV and research allegations against Dr. Potti, we moved quickly to take appropriate actions.

* Due to the allegations, a formal institutional investigation related to Dr. Potti's biographical claims was initiated on Friday, July 16, the date the allegations became public.

* Given the investigations that were initiated, Dr. Potti was placed on administrative leave at the end of the day Friday, July 16.

* With renewed questions about the integrity of the science that was the basis for three clinical trials, the investigators of those trials suspended further enrollment indefinitely pending a full, external scientific review of the science. Those holds on enrollment were implemented on Sunday, July 18.

 

In addition to these immediate actions, we have been working to engage major, nationally distinguished scientific organizations to conduct a far-reaching independent evaluation of the science that has been questioned, as well as to comment on this field of research. We have committed that this review will be independent of any Duke involvement. Duke will provide unfettered access to all data and materials, including the results of the previous review, in an open and transparent fashion. Such an independent review should provide a necessary and definitive answer regarding the questions that have been raised, as well as potentially providing guidance related to the kinds of reviews that are needed in this field as laboratory research moves into human investigation.

In order to remove any possible appearance of conflict of interest, Duke has decided to permanently divest all equity and potential royalties associated with this science that had been licensed to an outside company. Although there are appropriate and comprehensive conflict of interest management plans in place for inventors, Duke's decision is to completely relieve itself of any perceived conflict or pressure.

Some you may ask why we are now initiating a comprehensive scientific review when an independent review in regard to this work was commissioned by the Duke IRB, and completed, back in January. That review, conducted by independent biostatisticians, was designed to specifically answer two questions that we believed to be at the heart of the questions about patient safety raised by the outside critics. Given the continued concerns and the demand by external scientists for a comprehensive review that goes well beyond the scope of the previous review, we are convinced that there is the need for a broader review, conducted by a major independent research agency.

Despite the issues we are currently addressing in this case, there is well deserved pride in our cancer research and treatment programs, and in our faculty who have created Duke's reputation for excellence in this field. In our recent work of creating a Duke Cancer Institute, I have continually been impressed and humbled by the quality of the faculty and their commitment to research, teaching, training and clinical care. This is an important time for Duke's cancer program and I'm truly thankful for the excellent work being done by all.

I will continue to update you in regard to this situation as developments warrant.