Flawed Cancer Trial at Duke Sparks Lawsuit

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BlankFlawed Cancer Trial at Duke Sparks Lawsuit

by Couzin-el on 9 September 2011, 3:38 PM

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 ph 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co-authored has been retracted over the past year.)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.

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.