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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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September 30, 2004

A Day With All the Bark Left On It

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Posted by Derek

The talk at every pharmaceutical company today was Merck's sudden withdrawal of their COX-2 inhibitor Vioxx. Merck has been having an awful time for the last year or two, and this really throws a burning tire on top of the whole heap.

They were running a study to see if Vioxx would help prevent the formation of colon polyps - evidence has been accumulating that COX-2 inhibition would be helpful in colon cancer, and Merck was going to put the idea to a rigorous test. Halfway through the three-year trial, though, things have come to an ugly halt. Not only was there no colorectal effect (at least, none so far), but the treatment group showed roughly twice the rate of serious cardiovascular side effects such as heart attacks and stroke. These doubts had followed Vioxx for several years now, after a JAMA-published analysis which seemed to suggest cardiovascular complications. But Merck contended that this earlier study was controlled against a group taking a cardioprotective drug, and therefore not sufficient evidence. That's not the case any more.

So what's this mean? Well, in the near term, Pfizer is going to rake it in with Celebrex and its successor Bextra. And Novartis will have a more open field to introduce their coming COX-2 drug Prexige. But are these problems confined to Vioxx, or is it a COX-2 mechanism effect that's going to keep showing up? As far as I know, these problems haven't been noted with Celebrex, but it may be incumbent on Pfizer to generate new data to make sure. If the drug is clean, then Pfizer gets my vote as the luckiest drug company I have ever seen, between the unexpected benefits of Lipitor and the unintentional safety of Celebrex.

Meanwhile, Merck is going to face a horrible tsunami of lawsuits. It's 10:20 EST as I write this, and when I search Google for the word "Vioxx", the first two sponsored links on the right side of the page are from tort lawyers already trolling for clients. Lawsuit-centered web domains are already active, and I'm sure that the radio ads will be on the air tomorrow. I hate to say it, but I don't see how Merck makes it through this without firing people at some point. It's a damn shame - even Merck's fiercest competitors respect their research prowess, and I hate to see the company damaged.

And in the long term? Matthew Herper has it right over at Forbes:

"In some sense, every medicine is a ticking time bomb, and existing studies may not be enough to know what is safe and what isn't. The drug development business was already risky and expensive. But it just got even worse."

Just what we needed. Man, sometimes I think I should answered that ad back in the 1980s and learned to drive the big rigs for fun and profit.

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