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Monday March 20th

Duke University Health System subject of suit from former clinical trial patients

Clinical trials might be a cancer patient’s last chance to get better.

But some former patients of Duke University Health System claim trials administered to them were flawed, and maybe even harmful.

Twelve plaintiffs sued Duke and its health system, naming five doctors in the suit. The patients had been enrolled in a trial that used genetic tests to predict the best chemotherapy treatments for lung cancer.

Former oncology professor Anil Potti, who helped develop the science behind the genetic testing, was named in the suit.

Potti resigned in November from Duke’s Institute for Genome Science and Policy and the School of Medicine after allegations were made that he falsified some of his academic credentials.

“Duke conducted clinical trials on cancer patients that should never have occurred,” said Thomas Henson Jr., the plaintiffs’ attorney, in an email.

UNC School of Law professor Richard Saver said there’s been an uptick in cases involving clinical trials in recent years, but not necessarily an uptick in wins for plaintiffs.

“Many of the patients are so ill that even if there had been credible issues of claim, it’d be hard to show that patients suffered any additional harm (because of the clinical trials),” Saver said. “The law here does not generously award damages for physical or emotional pain.”

Mary Jane Gore, spokeswoman for Duke Medicine, said the university and health system could not comment on active litigation.

Henson said the patients involved in the clinical trials were informed of potential problems in letters from December 2010 to February 2011.

“The letters did not specify the problems that existed nor any of the details surrounding the scandal, so our clients knew very little about the background of the clinical trials and the potential consequences,” he said.

Saver said the case is straightforward because it involves claims of negligence. But the question of Duke University’s level of responsibility — since both the university and its health system were named as defendants — is at the forefront of the case, he said.

“The other issue is not who wins, but the publicity about this suit is probably bringing regulatory attention to clinical trials at Duke,” he said. “They can take a hard look at what’s going on at Duke and that could bring them hard regulatory attention.”

Saver said clinical trials are regulated by some state laws and the U.S. Department of Health and Human Services and the Food and Drug Administration at the federal level. Institutional review boards also exist within health systems to regulate the trials, he said.

Dr. John Harrelson, vice chairman of Duke School of Medicine’s Institutional Review Board, is currently named in the suit.

“One of the primary reasons our clients are pursuing this litigation is to uncover the whole truth behind what happened, so that future patients will be better informed and know the true dynamics behind clinical trials such as these,” Henson said.

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