Lawsuit against Duke Researchers over cancer clinical trials

DURHAM – Duke University and the Duke University Health System have been charged with negligence and other wrong doings by two cancer patients and the estates of six others. The allegations arose from the science and work of the disgraced researcher Anil Potti.

In a lawsuit filed in the state court on Thursday, two spinoff companies, Potti, and four other researchers or administrators have been sued apart from Duke.
Patients and their attorney, Thomas Henson Jr., have alleged against Duke and the health system in a 90-page document accusing them of their utter disregard to several indications regarding Potti’s flawed research that was invalid and later covered up for deficiencies.

The lawsuit argues that the defendants “engaged in a systematic plan to develop for-profit cancer tests for the primary purpose of generating billions of dollars in revenue,” at the expense of “actively protecting the safety and rights of patients in proper clinical trials.”

The suit further states, “they chose a path of conduct that was evasive, deceptive, misleading and fraudulent by falsely representing that the delivery of chemotherapy agents to human subjects was based on valid science, when in fact they either knew or should have known that it was not.”

Actual and disciplinary damages are being sought by patients and estates. The amount specified is uncertain, apart from the standard comment in state liability cases wherein the defendant is charged with at least $10,000.

Several of their claims included challenges to the constitutionality of state decrees that govern the handling of medical-malpractice cases and limit punitive-damages awards.

Until last year, Potti was a supposed rising star of Duke for research that treatment for various cancer forms could be perfected by doctors through genetics-based testing.

The papers published by Potti and co-author Joseph Nevins, another Duke Professor who is also one of the named defendants in the lawsuit, led to the conduct of three clinical trials wherein genetic tests were used to design treatment strategies for lung- and breast-cancer patients. The trials have witnessed participation from over 100 patients.

However, right from the beginning in 2006, the community outside Duke found Potti’s and Nevins’ claims to be a matter of grave controversy.

At several instances, analysts from the University of Texas, the University of Michigan, the federal FDA, the National Cancer Institute, and the U.S. Patent and Trademark Office voiced their concerns and queried various points. They either demanded information about Potti’s data or raised concerns about whether it was assembled in a proper fashion, utilized, and deduced.

The eventual outcome was that critics were not able to reproduce the research findings of the Duke team: this was a problem in itself identified and acknowledged by Nevins last year when he had requested a medical journal to revoke one of the papers co-authored by him.

The lawsuit further asserts that the problem was covered up by administrators by ordering a review of the research, which was fatally compromised in the first place owing to conflicts of interest.

In addition, the suit alleges that Duke Health Vice President Michael Cuffe, Vice Dean for Research Sally Kornbluth, and Institutional Review Board Chair John Harrelson- the three other defendants-did not provide reviewers with information regarding the concerns raised by critics at the University of Texas.

This approach undermined the review and established that administrators were “more committed to protecting the reputation, research, wealth and proprietary interests of Nevin, Potti” and Duke “than in protecting the safety of the patients involved in the clinical trials.”

Potti’s false claims on grant applications about being a Rhodes Scholar, as evidenced by a Washington, D.C., publication The Cancer Letter, led to the termination of trials.

The investigating University confirmed that there were “issues of substantial concern” regarding Potti’s credentials, which resulted in his departure from Duke.

Amongst other things, the lawsuit places Duke Officials at fault for not authenticating Potti’s credentials prior to the public release of The Cancer Letter in the summer of 2010.

It is typical of Duke Officials to avoid discussions on lawsuits; hence, they refrained from responding to a request for comment on Friday.

However, as early as this month, there have been acknowledgements from various officials regarding the school’s error in handling of the issue. For instance, professor and head of Duke Institute for Genome Sciences & Policy, Hunt Willard, was the latest admission. Nevins and Potti work or worked for a branch of the institute.