Marilyn Mann Points Us To New, Detailed Post-Hoc Vioxx® Data Analysis


An abiding and constant friend of this blog has pointed us to yet another Merck-related story we missed, when it originally came out. So, we are belatedly highlighting it here, with sincere thanks to Marilyn Mann.

A blogger who studies math has spent some time corroborating one of the Vioxx® case plaintiffs’ expert data-analysis — assembled largely from the trial work on the US Vioxx cases. Do go read it all, but here is a bit:

. . . .Yesterday I caught a lecture at Columbia given by statistics professor David Madigan, who explained to us the story of Vioxx and Merck. It’s fascinating and I was lucky to get permission to retell it here.

Disclosure

Madigan has been a paid consultant to work on litigation against Merck. He doesn’t consider Merck to be an evil company by any means, and says it does lots of good by producing medicines for people. According to him, the following Vioxx story is “a line of work where they went astray”.

Yet Madigan’s own data strongly suggests that Merck was well aware of the fatalities resulting from Vioxx, a blockbuster drug that earned them $2.4b in 2003, the year before it “voluntarily” pulled it from the market in September 2004. What you will read below shows that the company set up standard data protection and analysis plans which they later either revoked or didn’t follow through with, they gave the FDA misleading statistics to trick them into thinking the drug was safe, and set up a biased filter on an Alzheimer’s patient study to make the results look better. They hoodwinked the FDA and the New England Journal of Medicine and took advantage of the public trust which ultimately caused the deaths of thousands of people.

The data for this talk came from published papers, internal Merck documents that he saw through the litigation process, FDA documents, and SAS files with primary data coming from Merck’s clinical trials. So not all of the numbers I will state below can be corroborated, unfortunately, due to the fact that this data is not all publicly available. This is particularly outrageous considering the repercussions that this data represents to the public. . . .

As I say, it is well worth the 15 minutes or so it will take to digest it all. For those interested, here is a similar, September 2011 post on the L’Affair Vioxx, also courtesy of the same friend of the blog.

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