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Families sue Duke over bogus cancer research

Posted September 8, 2011

 Duke University

— Two patients and the families of six others have filed suit against Duke University, the Duke University Health System and several affiliated physicians over clinical trials linked to a discredited researcher.

The group is seeking compensatory and punitive damages in the case, alleging that Duke tried to cover up questions about the research and performed unnecessary chemotherapy on people in hopes of patenting and spinning off a cancer-screening test.

Duke halted work on the clinical trial last year after learning that Dr. Anil Potti exaggerated his credentials, including claiming that he was a Rhodes scholar. Potti, who resigned in November, was an associate professor of medicine at Duke's School of Medicine and the university's Institute for Genome Science & Policy.

Two published papers based on his research were retracted last fall after a collaborator said the results of Potti's work couldn't be reproduced.

The lawsuit, filed Wednesday in Durham County Superior Court, alleges that researchers raised questions about Potti's research as far back as 2006, noting that Potti misused data and produced flawed results.

Despite repeated warnings by outside researchers, the lawsuit states, Duke enrolled patients in three clinical trials. The university finally began an internal investigation in late 2009, but the panel assigned to review Potti's research and the clinical trials had numerous ties to Potti and collaborator Dr. Joseph Nevins, according to the lawsuit.

Once details of the faulty research became public last year and the American Cancer Society stopped paying Duke on a grant, the university sent form letters to patients in the clinical trials that "minimized and misstated the extent of and severity of the problem and the potential risks" to patients, the lawsuit states.

The university also "threatened staff with retribution, including legal action," to prevent questions about Potti's research from being raised, according to the lawsuit.

"The entire response by Duke University and/or (the Duke University Health System) to the accusation of invalid and fraudulent science was deceptive misleading and fraudulent conduct designed to protect its reputation and proprietary interests ... rather than protecting the safety of the patients involved in the clinical trials," the lawsuit states.

Six of the eight plaintiffs have since died, according to the lawsuit. All suffered from lung cancer and enrolled in the clinical trials under the belief that they would receive "better than the standard chemotherapy" and would have "a higher likelihood of a favorable response."

The other two plaintiffs are a Richmond County man with lung cancer and a Buncombe County woman with breast cancer.

"The fact is Duke conducted clinical trials on cancer patients that should have never been done. The trials themselves were based on invalid science," said attorney Thomas Henson Jr. who represents the eight plaintiffs. "Respected researching in the oncology world were warning Duke and telling them about the invalid science and ultimately Duke failed to give full and informed consent in terms of what was being done to them."

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  • silverblackman Sep 9, 12:51 p.m.

    Yes, it is me again. Believe it or not, Anil Potti is now licensed as a Physician in South Carolina (Coastal Cancer Center, Myrtle Beach). It is my understanding that he is still involved with Cancer trials. I have seen his application for a Medical License in South Carolina, and, it appears that he is still stretching the boundaries of the truth, and in my opinion, there are flat out lies stated therein. He was also able to get four letters of praise and referral from Duke Medical higher-ups to attach to this application. The letters mentioned such things as integrity, honesty and other high praise for this individual. I believe that Anil Potti is still on the Duke payroll. Apparently, they have recently decided not to represent him legally if litigation is initiated. One thing that Duke can not retract is the complicity of Potti, Nevins, Marcom and many others that participated in this fraud. More, much more to follow
    1. The following is a comment that I posted one year ago, it is st

  • FromClayton Sep 9, 11:12 a.m.

    tisk tisk, dark cloud on duke's good name in cancer research and treatment....shame on you duke. These are people! Not lab rats in a hospital gown!

  • happymom Sep 8, 7:42 p.m.

    "AS A HEALTHCARE WORKER, MY EXPERIENCES LEAD ME TO BELIEVE THAT THIS IS NORMAL. THE EXPRESSION, YOU CAN'T MAKE AN OMLETTE WITHOUT BREAKING A FEW EGGS COMES TO MIND HERE."

    This wasn't just healthcare. This was research, and there are considerable ethical obgligations beyond normal healthcare that were violated by this doctor and Duke University. It is jaw-dropping to me that either Duke's IRB wasn't made aware of the misreprentations or that it didn't immediately take action to halt the doctor's work and inform the patients in the study.

    Duke should have checked references. And the co-investigators on the study should have notified both the IRB, the study's funding organization, and the patient research participants once they were aware of the problem. The system failed here- all the way around.

  • dirkdiggler Sep 8, 7:40 p.m.

    How absolutely disgusting.

  • RB aka Spirit Warrior Woman Sep 8, 6:45 p.m.

    deeper - "WE ALL WISH TO BE TREATED AS A SPECIAL PERSON WHEN WE GO TO THE DOCTOR BUT SADLY 99% OF US ARE JUST ANOTHER DOLLAR SIGN IN A GOWN."

    Then hefty fines, legal fees and possibly legal charges might change that.

  • RB aka Spirit Warrior Woman Sep 8, 6:44 p.m.

    "Duke halted work on the clinical trial last year after learning that Dr. Anil Potti exaggerated his credentials, including claiming that he was a Rhodes scholar. Potti, who resigned in November, was an associate professor of medicine at Duke's School of Medicine and the university's Institute for Genome Science & Policy."

    It's unconscionable that Duke didn't check this man's background thoroughly before hiring.

    Might just as well have let a janitor do this work.

    So yes, Duke is responsible in my opinion, and they should pay and pay BIG.

  • look deeper Sep 8, 5:16 p.m.

    "The entire response by Duke University and/or (the Duke University Health System) to the accusation of invalid and fraudulent science was deceptive misleading and fraudulent conduct designed to protect its reputation and proprietary interests ... rather than protecting the safety of the patients involved in the clinical trials," the lawsuit states. AS A HEALTHCARE WORKER, MY EXPERIENCES LEAD ME TO BELIEVE THAT THIS IS NORMAL. THE EXPRESSION, YOU CAN'T MAKE AN OMLETTE WITHOUT BREAKING A FEW EGGS COMES TO MIND HERE. WE ALL WISH TO BE TREATED AS A SPECIAL PERSON WHEN WE GO TO THE DOCTOR BUT SADLY 99% OF US ARE JUST ANOTHER DOLLAR SIGN IN A GOWN.