NBC-17 Investigates FDA findings in Duke audit

NBC-17 Investigates has uncovered the findings of the FDA’s year-long audit of Duke University Health System.

The U.S. Food and Drug Administration began inspecting Duke’s Institutional Review Board after a former Duke researcher and oncologist, Dr. Anil Potti, was forced to resign.

Before his resignation, Potti admitted he embellished his resume to obtain a grant from the American Cancer Society to help fund clinical trials.

The trials were first made public in 2006, when Duke Medicine’s News and Communications Office released a public statement saying the model developed by Duke researchers, including Potti, have “promising results” and have “initiated a landmark multi-center clinical trial.”

The trials, conducted at Duke between 2007 and 2010, assigned patients with early-stage non-small cell lung cancer to treatments based on now-discredited gene expression patterns that Potti and his mentor, Dr. Joseph Nevins, claimed they had identified in tumor cells.

Nearly a dozen cancer patients and the families of those patients who are no longer living have filed a lawsuit against Duke University, Duke University Health System, administrators, researchers and physicians alleging that they knew or should have known about Potti’s questionable research.

In the 73-page complaint filed in Durham Superior Court, the plaintiffs allege that the defendants allowed the cancer trials to continue while ignoring public warnings from outsiders. Those warnings first came from two biostatisticians at M.D. Anderson Cancer Center in Houston who discovered the underlying research of the trials was faulty and could put patients at risk by exposing them to ineffective or dangerous treatments.  

In addition, the complaint alleges that in 2006, an investigator from the National Cancer Institute alerted Duke, Nevins and Potti to flawed science published in the 2006 article.

In 2010, Duke canceled the trials and informed participants that the treatments they received may have done little or nothing to stop tumor growth.

In January 2011 the FDA began inspecting the Institutional Review Board (IRB) at Duke University Health System. According to the audit, Duke’s IRB has the authority to approve, disapprove or require modification to research studies as well as suspend or discontinue research if the IRB believes the study is not being conducted according to requirements or if “human subjects are questioned or protocol compliance is an issue.”

And FDA representative, Erica Jefferson, told NBC-17 that models like the one being used in the clinical trials require FDA approval of an Investigational Device Exemption (IDE) prior to beginning a clinical trial.

“In general, clinical trials of in vitro diagnostics that direct patient treatment for serious disease as part of the trial, such as the one at issue here, are significant risk studies that require FDA approval of an IDE,” said Jefferson.

Duke did not obtain an IDE nor submit pre-clinical data in an investigational application before beginning the trials, as required by the FDA.

The audit found “no significant deficiencies” in IRB conduct.

“However, it was not possible for FDA to assess the allegations made by MD Anderson about the algorithm supporting Dr. Potti’s genetic profiling test. If the required IDE had been submitted, FDA could have requested and reviewed this data before the study began,” Jefferson told NBC-17.

During the on-site audit, FDA investigators interviewed Dr. John Falletta, Senior Chair for Duke IRB.

According to the audit, Falletta told the FDA “the IRB now realizes that it was probably wrong to assume everything was OK to proceed.”

In regards to the model that was central to the clinical trials, Falletta told the FDA “The IRB realizes now that the device does pose significant risk and that an IDE should have been filed.”

Currently, all three clinical studies have been closed.

Duke declined NBC-17 requests for an on-camera interview and did not answer the specific questions submitted via email but sent NBC-17 a statement saying that Duke has fully cooperated with the FDA and “…we have identified this as an area in which we will make significant improvements moving forward.”