Flawed Cancer Trial at Duke Sparks Lawsuit

A dozen plaintiffs have filed a lawsuit against Duke University and administrators, researchers, and physicians there, alleging that they engaged in fraudulent and negligent behavior when they enrolled cancer patients in a clinical trial compromised by faulty data. The lawsuit, filed Wednesday in a North Carolina court, comes 14 months after a scandal erupted at Duke that finally exposed the extent of the trial's problems: in July 2010, Duke oncologist Anil Potti, whose work was central to the trial, admitted that he had embellished his resume and later resigned.

The plaintiffs -- cancer patients who were in the trials and the families of trial participants who are no longer alive -- say that Duke officials long knew that the work of Potti and Joseph Nevins, a cancer geneticist who was director of Duke's Center for Applied Genomics & Technology, was "highly suspect" but launched clinical trials based on it anyway. (A raft of papers the pair co-authored has been retracted over the past year.) "In May 2007, after being placed on notice of the flawed science underlying its cancer studies as referenced above, Duke University and/or DUHS [Duke University Health System] nevertheless began their first clinical trial," the lawsuit asserts. That trial assigned patients with lung cancer to certain treatments based on now-discredited gene expression patterns that Potti and Nevins said they had identified in tumor cells.

The lawsuit is scathing in its assessment of how Duke handled the mounting concerns voiced by outsiders, in particular two biostatisticians at M.D. Anderson Cancer Center in Houston, Texas.

The plaintiffs claim that Duke's response "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 continues: This "reduced the Plaintiffs' likelihood of surviving his/her cancer or the likelihood of experiencing a positive response to the chemotherapy regimen."

The plaintiffs want at least $30,000 each in damages, and a trial by jury. Duke University has said it cannot comment on active litigation. Meanwhile, the Institute of Medicine is studying how gene expression profiles are used in medicine and expects to wrap up the project next year.