Pelley: Is it a close call? Or is it abundantly clear that the data were fabricated?
Nevins: Abundantly clear.
Pelley: When you switch the data, the theory is proved. If you put the data back the way it's supposed to be, the theory fails.
Dr. Rob Califf: The theory's a dud if you put the data back to where-- the way it was supposed to be.
Pelley: How could that switch happen?
Dr. Rob Califf: If it happened by chance, it would be roughly equivalent to an asteroid hitting the earth.
Duke University agreed to tell us this story as a cautionary tale for other institutions. Vice Chancellor Rob Califf is implementing new procedures for Duke and also overseeing the retraction of Dr. Potti's papers from the medical journals, one of the most significant retractions in medical history. He's examining how both a prestigious university and outside investigators missed all the warning signs.
Pelley: How could they have found nothing wrong, nothing suspicious about the work at that point?
Califf: They were analyzing a data set that had been prepared by Dr. Potti. So, the data set they got was one that produced the same results that had been seen in our own analyses.
Pelley: You know there are people watching this interview who are thinking to themselves, "Look, they stood to be wealthy. The university stood to make a lot of money. No one wanted to believe that this research was corrupt." To what extent was that the reason that the warning signs were overlooked?
Califf: In my view, it was not the money that was the primary driver, it was this great opportunity to help people that was driving people to say, you know, we've got to make this work because it looks so good.
Pelley: The patients were told that there was an 80 percent chance that precisely the right drug for their tumor would be found. That wasn't true. Do you bear any responsibility for that?
Nevins: I regret that some of the issues that were raised along the way I didn't recognize earlier, and that this could have been brought to a halt at an earlier time.
Juliet Jacobs died three months after she entered the clinical trial. Walter Jacobs and eight others have filed suit. In his answer to the Jacobs lawsuit, Dr. Potti says he was "not aware that false or 'improper' information had been included in the research." Duke has apologized for the trials. And even though the patients hoped that they were getting an innovation that could save their lives, Duke says no one was really harmed because all of them received the standard of care in chemotherapy.
Jacobs: They did not advertise this as a standard of care program, they advertised this as an advanced clinical trial with great results. For what happened to my wife, I have to blame Potti and anyone else associated with him who knowingly promoted a false counterfeit clinical trial exploiting human beings.
Dr. Potti resigned from Duke. He faces an investigation into research misconduct. He told us, in an email, that it would be inappropriate for him to comment. He wrote, "My primary concern at all times is and will be the care of patients and seeking new ways to treat cancer." These days, he's working as a cancer doctor in South Carolina. And if you look online, you will see that he is celebrated for "his significant contribution to the arena of lung cancer research." The websites were created with the help of an online reputation consultant, perhaps to put the best face on the available data.