It is perhaps the biggest drug scandal of recent years. Before Merck withdrew Vioxx in 2004, the popular painkiller was linked to heart attacks in tens of thousands of people. Now researchers have alleged that Merck knew of the dangers years earlier, but tweaked statistics and hid data so that regulators remained in the dark.
Numbers don't lie, but apparently, numbers can be easily manipulated to justify death for profit:
But an analysis of documents released during the litigation process that led to that settlement, carried out by Richard Kronmal, a statistician at the University of Washington, Seattle, who acted as an expert witness in the Merck lawsuits, suggests that company scientists were aware of the problems well before 2004.
Kronmal's study, co-authored with colleague Bruce Psaty, focuses on a 2001 internal company report. In it, Merck staff describe two recently completed trials involving around 1000 patients on Vioxx and a roughly equal number taking a placebo. Thirty-four people taking the drug died, compared with just 12 on the placebo.
But when Merck submitted the results to the US Food and Drug Administration (FDA) the same year, the company analysed the data in a different way. Deaths that occurred after patients completed their course of Vioxx appear to have been removed from the results, even though the drug can cause problems after patients stop taking it. Removing the deaths reduced the risk attributed to Vioxx.The studies still prompted the FDA to ask whether the risk associated with the drug was enough to warrant stopping another ongoing trial, but Merck replied that it wasn't. According to documents cited by Psaty and Kronmal, the company described the increase in mortality – which its own report revealed to be threefold – as "small numeric differences… most consistent with chance fluctuations".
Chance fluctuations? Unbelievable. Let's end this post with a quote:
"It completely clouds your ethical responsibility," says Merrill Goozner, director of the Center for Science in the Public Interest in Washington, D.C.
You think?