Why the Data Diverge on the Dangers of Vioxx

The New York Times May 22, 2006 Why the Data Diverge on the Dangers of Vioxx By ANDREW POLLACK and REED ABELSON Eighteen months. Ever since Merck pulled its arthritis painkiller Vioxx off the market in September 2004 on evidence that it could cause strokes or heart attacks, the company and its lawyers have stood by the premise that it was dangerous only to patients who took it for at least 18 months. So it was news last week when prominent medical experts said that new data from Merck indicated that Vioxx's risks started to emerge after only four months of use. The controversy is the latest illustration of how widely open to interpretation and potential corporate pressure the results of clinical trials can be even when reported in a leading medical journal. While he acknowledged that Merck was involved in reviewing the manuscript, he said the paper's authors responded to all the comments raised by the editor and the reviewers and that the final draft reflected changes made to address their concerns. "The end product was a good final product," he said. "If The New England Journal didn't think this was an appropriate and satisfactory product, they didn't have to publish it," Dr. Bresalier said. While Dr. Bresalier and the other outside authors reached insisted that they felt comfortable with how the risks were eventually portrayed, he said the 18-month finding was not seen as critical by the researchers, even if it had been "up-played" by Merck and its lawyers. "Of course they want to minimize their liability," he said.