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Pharma & Bio Ingredients
The correction supports the contention of many doctors and lawyers that risks showed up with as little as four months of use.
"If I was a plaintiff's lawyer, I would say, 'This is like manna from heaven,'" said David Logan, dean of Roger Williams University School of Law. "It makes it very difficult for Merck to say with a straight face ... in front of juries that they proceeded in a cautious way with concern for the public."
Heart attacks and strokes occurred more frequently after people had been on the drug for at least 18 months, but the actual harm might have occurred much earlier, said Dr. Jeffrey Drazen, editor-in-chief of the journal. He worked with the authors to correct their original findings of the APPROVe trial, published in March 2005.
"It's a subtle but very critical point," Drazen said, comparing the situation to health problems being detected months after exposure to excessive radiation.
Cleveland Clinic cardiologist Dr. Steven Nissen, who has challenged the study's conclusions in the past and did so again in a separate letter also published online by the medical journal on Monday, agreed.
"A key legal defense in the liability cases has been the suggestion that there was no risk until patients had taken the drug for 18 months," he said. Now, with the correction, "the authors have removed any claim that there was a delay in risk."
