Report shows review of Potti research was based on flawed data

A report obtained under the U.S. Freedom of Information Act by the academic journal Nature provides new insight into a panel that reviewed the findings of Duke cancer researchers.

The document details a review completed in December 2009 of work by Drs. Anil Potti, William Barry and Joseph Nevins. The University had suspended trials based on their research and asked Duke’s Institutional Review Board to review the work after two biostatisticians challenged its ability to be reproduced. The IRB was able to replicate Potti’s results and Duke therefore resumed clinical trials, but the report released by Nature reveals that the review panel validated the doctors’ research using data provided by Potti that did not match original raw data.

Keith Baggerly, one of the biostatisticians from the University of Texas’ MD Anderson Cancer Center, sent a document to Duke administrators warning them that the data Potti had released online did not match raw data available in public databases. But the Duke officials never forwarded the information to the panel, therefore jeopardizing the quality of its review.

“We think the outside experts would have had a better chance of detecting the error if they’d been told that we’d already found it,” Baggerly told Nature.

In a joint statement to Nature, Vice Dean for Research Dr. Sally Kornbluth and Vice President for Medical Affairs Dr. Michael Cuffe said they received the document but decided not to pass the information on to the panel because they feared it might bias the review.

“It was determined that it would be best to let the data, publications, etc., speak for themselves and not bias the independent investigation for or against any party. In retrospect, we did not realize that the data provided by our investigators were flawed (as the public record now shows), rendering an outside review addressing the methodology flawed as well. In hindsight, we would have ensured that the IRB provided all communication with Dr. Baggerly, recognizing the risk of bias. We’ve learned considerably from this process and are introducing key changes in the way we deal with research that will be translated to the clinical arena as a result.”

Cuffe told Nature that if a similar situation were to ever occur again, he would forward “every shred” of evidence to the review panel.

“Our motivation was not to protect [Potti], it was to give him complete fairness,” Kornbluth said.

The University has decided to consider a stronger review process following the incident. Cuffe and Kornbluth noted Duke has set up a committee to determine what criteria should be required and checked before any clinical trials can begin.

The research concerned the potential for personalized chemotherapy treatments for specific patients based on biological markers and genomics. The three clinical trials have since been terminated and the research is being further reviewed by the Institutes of Medicine, which is expected to complete a report by 2012.

Potti, one of the researchers, resigned Nov. 19 months after The Cancer Letter revealed inconsistencies in his resume. Two papers he co-authored have also been retracted.


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