Vytorin Study Raises Ethical Questions
September 3rd, 2008 laurie
Forbes reports that cardiologists and statisticians are arguing about whether the cholesterol drug Vytorin might increase the rate of cancer deaths. But experts on both sides of the argument agree on one thing: They don’t like the way the results were made public. Instead of appearing first in a medical journal where results are carefully vetted by anonymous outside experts, as is the tradition for scientific papers, the researchers involved organized a press conference that was funded by the company.
Key data being used to argue that Vytorin does not cause cancer come from two ongoing studies whose results would normally be known only by a top-secret committee charged with guarding the safety of patients in the trial. Instead, those results have been released to the entire world.
Terje Pedersen, the lead investigator of the study, called SEAS, says he had no choice but to release the results early. Pedersen, of Ulleveal University Hospital in Oslo, Norway, says he “wanted to do this in peace and quiet” and present the full results at the annual meeting of the American Heart Association in New Orleans in November.
Merck and Schering have come under heavy criticism for another Vytorin study, called ENHANCE. The lead investigator of that trial has said that the results might have been out a year earlier had the companies left the decision to analyze the data up to him.
Vytorin was withdrawn from the market after it was shown to cause heart attacks.
