MGH editor threatens retraction after lung study consent problems

The NYTimes reports that the doctors who conducted the 50,000 patient lung cancer screening trials “were unable to locate 90 percent of the consent forms.”

The finding casts further doubt on a clinical trial that made headlines in 2006 when it concluded that fully 80 percent of lung cancer deaths could be prevented through wide use of CT scans.

That trial, led by Dr. Claudia I. Henschke at Weill Cornell Medical College in New York City, drew sharp criticism from skeptics of cancer screening; the criticism intensified when The Times reported in March 2008 that the research was being financed in part by $3.6 million in grants from the parent company of the Liggett Group, a cigarette maker.

The confidential report on patient consent, dated Oct. 7, 2008, recommended that the trial be stopped. But it continues to this day, although not at Weill Cornell.

The Cancer Letter also reports extensively on the case.

The story further reports:

Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chief of The Oncologist journal, said he would ask Weill Cornell for an explanation of the problems outlined in the 2008 scientific review, as well as a follow-up to the report. His journal has published research by Dr. Henschke, and “if we find there was no informed consent for those patients, the paper would have to retracted,” he said.

Finally, the story also quotes Dr. P. Pearl O’Rourke, director of human research affairs at Partners HealthCare.

Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chi

The responsible conduct of a study requires that informed consent documents be kept on file,” said Dr. P. Pearl O’Rourke, director of human research affairs at Partners HealthCare, part of Harvard University. “There should be a system so that every consent form can be found no matter if individuals were enrolled at a single site or multiple sites.”

John D. Rodgers, a spokesman for Weill Cornell, wrote in an e-mail that the medical school followed federal research regulations “and there were no issues regarding the safety of the research subjects.”

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