Researcher implicated in manipulation of cancer data leaves Coastal Cancer Center

A doctor accused of manipulating cancer research data while he worked at Duke University is no longer employed with Coastal Cancer Center.

The cancer care facility announced Wednesday Dr. Anil Potti, a former Duke researcher and oncologist, "is no longer associated with Coastal Cancer Center of Myrtle Beach" after it became "obvious that this issue is going to take precious focus away from patient care."

"Coastal Cancer Center is staffed by incredibly caring people who want and need to concentrate on providing outstanding patient care," the facility explained in a press release.

Despite the on-going scandal involving flawed cancer clinical trials at Duke, Coastal Cancer Center says it conducted a “deep and thorough investigation" of the Potti's credentials before hiring him in March 2011.

"We received glowing references about Dr. Potti's character and skills from the highest ranks of the Duke University School of Medicine and Duke University Medical Center," said Coastal Cancer Center President Lawrence B. Holt.

The Coastal Cancer Center said such letters of recommendation from Duke were “key factors” in the center’s decision to hire Potti.

“During his tenure at Duke, Anil developed an impressive research program…," read one letter of recommendation from Duke University’s Chief of Medical Oncology, Dr. Jeffrey Crawford, MD.

“I personally would be delighted to have Dr. Potti as a faculty member in our physician practice, or as an oncologist taking care of one of my family members."

Crawford’s letter is dated Jan. 7, 2011, months after Potti resigned and admitted he embellished his resume to obtain a grant from the American Cancer Society to help fund clinical trials.

Wednesday, Duke declined to comment on Coastal Cancer Center’s announcement but directed NBC-17 to a previous statement from Crawford who explained that he wrote the letter of recommendation prematurely.

Medical industry watchdog, Dr. Gene Nelson expressed concern that the South Carolina Medical Board was unaware of the issue.

Nelson said he called the medical board after the scandal broke and, “They were genuinely surprised that somebody they had given the green light to was the subject of a “60 Minutes” exposé. And I know (NBC-17) was on the story more than a year before the "60 Minutes" story came out.”

Nelson says another issue of concern is that Potti has paid a company to improve his online reputation. NBC-17 investigates found Anil Potti is listed as the registered owner of a domain that hosts a glowing online biography and resume for Potti.

The trials in question 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 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, said models like the one being used in the clinical trials require FDA approval of an Investigational Device Exemption 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," Jefferson said.

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 said.

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 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."