Key Vioxx Research Was Written by Merck, Documents Allege

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The researchers cited two Vioxx studies, one published in 2004 and one published in 2005, in which the company reported more patient deaths in the Vioxx groups but did not analyze the mortality data and simply said the drug was well-tolerated. However, the company's internal analysis in April 2001 had noted a threefold increase in death risk, although an updated safety report it submitted to the FDA in July 2001 used a method of analysis that "minimized the appearance of any mortality risk."

"It's really not appropriate that you only present the data the way that makes the drug look safe," Nissen said. "Taken together, [these papers] paint a very ugly picture of medicine really at its worst. My own hope is that the sunlight that has shone now on this process will cause people to take a closer look, and I hope people will really read those manuscripts and, when they're approached, do things that are ethical."

"This was amazing sleuthing," Nissen continued. "The thing that you can't lose in all of this, amid the corporate misconduct story, is that patients were harmed. We have a right to have all the information on the table, so we can make intelligent decisions. And, in this case, the information we had was not fair, balanced and scientifically appropriate. It was colored in the process of generating these ghost-written manuscripts and by hiding safety data."

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In the accompanying editorial, those at the helm of JAMA called for changes that would affect almost everyone involved in the pursuit of medical research, including tightening the requirements of study authorship, publishing all sources of funding for every study, requiring independent statistical analysis of trial data, creating punishments for anyone who fails to follow the rules, and establishing a complete financial separation between the medical profession and the drug industry.

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