Trial in Medical Research Scandal Postponed
By Jay Price
DURHAM, N.C. — A judge in Durham County Superior Court has postponed the first civil trial against Duke University by the estate of a patient who had enrolled in one of a trio of clinical cancer studies that were based on bogus science.
The case is part of what the investigative TV news show “60 Minutes” said could go down in history as one of the biggest medical research frauds ever.
The trial had been scheduled to start Monday, but several attorneys involved contracted flu. Judge Robert C. Ervin hasn’t settled on a new start date, but after a conference call with him Monday night, attorneys in the case said it could be as late as this fall.
Flu? Don’t these lawyers get flu shots? Wasn’t Duke working on a flu vaccine? Delaying til Fall 2015?
The postponement delayed resolution in the long-running case for the two patients still alive among the eight who filed suit. It also prolonged a lengthy public relations headache for Duke Medicine that has included retraction of research papers in major scientific journals, the embarrassing segment on “60 Minutes” and the revelation that the lead scientist had falsely claimed to be a Rhodes Scholar in grant applications and credentials.
Because it’s not considered a class action, the eight cases may be tried individually. The one designated to come first was brought by Walter Jacobs, whose wife, Julie, had enrolled in an advanced stage lung cancer study based on the bad research. She died in 2010.
“We regret that our trial couldn’t go forward on the scheduled date,” said Raleigh attorney Thomas Henson, who is representing Jacobs. “As our filed complaint shows, this case goes straight to the basic rights of human research subjects in clinical trials, and we look forward to having those issues at the forefront of the discussion when we are able to have our trial rescheduled.”
It all began in 2006 with research led by a young Duke researcher named Anil Potti. He claimed to have found genetic markers in tumors that could predict which cancer patients might respond well to what form of cancer therapy. The discovery, which one senior Duke administrator later said would have been a sort of Holy Grail of cancer research if it had been accurate, electrified other scientists in the field.
Then, starting in 2007, came the three clinical trials aimed at testing the approach. These enrolled more than 100 lung and breast cancer patients, and were eventually expected to enroll hundreds more.
Duke shut them down permanently in 2010 after finding serious problems with Potti’s science.
Now some of the patients – or their estates, since many have died from their illnesses – are suing Duke, Potti, his mentor and research collaborator Dr. Joseph Nevins, and various Duke administrators. The suit alleges, among other things, that they had engaged in a systematic plan to commercially develop cancer tests worth billions of dollars while using science that they knew or should have known to be fraudulent.
The latest revelation in the case, based on documents that emerged from the lawsuit and first reported in the Cancer Letter, a newsletter that covers cancer research issues, is that a young researcher working with Potti had alerted university officials to problems with the research data two years before the experiments on the cancer patients were stopped. Continue reading