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?