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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: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Comment Problems | Main | DNA to Drug? »

October 3, 2004

More on Merck

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Posted by Derek

I see that some of the Merck/Vioxx coverage has been along the lines of "Company Finally Heeds Warnings of Unsafe Drug." Boy, the tort attorneys have to love that sort of thing. It's true that Merck had some signs that Vioxx could have cardiovascular problems, but there are a lot of drugs, unfortunately, that show rumblings of this sort. Some of them turn out to be false alarms, and some of them turn out to be real. This one turned out to be real with fangs.

If we immediately pulled every drug that showed any indication of trouble, it's for sure that no patients would come to harm. But we wouldn't have very many drugs, either. It's possible that Merck could have moved more aggressively to see if Vioxx had these problems or not - but if companies immediately ran fully-powered studies to address every red light that comes on, we'd have even more enormous costs to make up than we do already. Nothing's free.

Our job, on the discovery and development side, is naturally to try to find things with the largest positive footprint and the smallest negative one. The size of the latter one never goes to zero; it can't. We try to figure out how big it is, but you can never be really sure until after the drug goes onto the market. It's sad, it's unnerving, but it's absolutely true. The mission of the FDA, in an ideal world, would be to ensure that only drugs that can cause no harm make it to market. In the world we find ourselves in, though, the mission is to balance the potential harm a new drug could cause with the good it could do. That's an awfully tough assignment.

And the job of the injury lawyers is to swoop down after the worst happens, cawing about "defective products" and "willful negligence", and bearing away the biggest chunks their beaks can carry. The sky over Merck is getting dark with them right now.

Speaking of carrying away things in beaks, remember the University of Rochester? A group there made some of the early COX-2 discoveries, and on the strength of a patent, wanted a piece of all the earnings of COX-2 inhibitor drugs. The suit failed, after years of wrangling, on the grounds that the patent did not provide any such compounds, nor did it (or could it) describe what such a drug would look like or be composed of. But if they'd won, do you think they'd be willing to pick up some of the liability? Soak up a little of the lawsuit pain? Or were they only in it for the sunny days while the money was flowing? What do you think?

Comments (3) + TrackBacks (0) | Category: Cardiovascular Disease | Drug Development | Toxicology


COMMENTS

1. Maynard Handley on October 8, 2004 6:13 PM writes...

When an industry makes drugs that save people's lives, and YET is so universally loathed that very few people are weeping at the thought of their being sued, the industry might want to take a look at how it comports itself and ask just why it is so univerally loathed.

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2. Lawrence B. Ebert on October 10, 2004 10:29 AM writes...

The CBS show Sunday Morning on October 10, 2004 began with a story on VIOXX. This piece included more general drug company issues and included a poll showing a strong decline in the perception of the drug industry by the public between 1997 and 2004.

The possible links between COX-2 inhibitors and strokes were being discussed by 2000, and there was a paper in the Proceedings of the National Academy of Sciences (PNAS).

It's an interesting question about the University of Rochester, but one that won't be answered.

Lawrence B. Ebert

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3. John Lehmann PhD on October 28, 2004 9:01 AM writes...

Responding to the question whether the cardiac dangers of Vioxx are drug-specific or relate to the entire class of COX-2 inhibitors (Coxibs), scientific evidence based on gene knockout studies pointed out that it is an adverse reaction associated with the mechanism, hence the whole class of drugs. See DrugIntel for details, where these problems for Vioxx were predicted in spring 2003.
Clinical studies confirming this danger take longer and suffer from less precision, and are more difficult to conduct objectively for obvious reasons. The Cochrane Reviews (2004) commented "For individuals in whom cardio-prophylactic low dose aspirin is indicated, the evidence suggests that
celecoxib [Celebrex] offers no additional benefit in terms of GI safety."
On the social aspects, agreed that withdrawing every drug with side effects or dangers would leave us with no drugs. However, judging Vioxx on medical risk-benefit, it never was a winning proposition - omeprazole + ibuprofen was judged to be safer, not to mention cheaper, by the Oregon Health & Science University / Oregon Health Resources Commission cogent and objective review on the topic. Hopefully the constructive result will be that Merck returns to its tradition of research resulting in truly novel drugs addressing unmet medical needs, rather than overmarketed, overpriced drugs with selling points rather than medical superiority.

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