Merck, you got some 'splainin to do!

The BBQ Pit
1

So, as anyone who stalks me here on the SDMB knows (I doubt I’m famous enough for stalkers), I’m hardly one to jump on a, “sue the bastards!” bandwagon and have a very skeptical view of most lawsuits against pharmaceutical companies, but this article in the NY Times has given me some rather serious pause.

Back when Vioxx was originally pulled from the market, I bought what Merck had said. Basically, they conducted a long-term safety study on Vioxx. Although the drug was safe up to 18 months, suddenly at 18 months they noted a statistically significant jump in heart attack risk among Vioxx users. They jumped on the data and immediately pulled the drug from the market. I though that the company acted responsibly and reasonably, the best that could be hoped given that they aren’t psychics. I disagreed with lawsuits such as the $253 M judgement against them in Texas for someone that had been taking the drug half of that time and died of an apparent arrhythmia rather than the type of cardiac drug Vioxx was suspected of causing. Similarly, I was heartened to see them win a case against a Postal Worker that had suffered a heart attack in New Jersey after taking the drug for a short period of time.

Now, what the fuck is this? The New England Journal of Medicine published an editorial, “Expression of Concern,” and a tandem statement condemning Merck’s behavior related to the publishing of data over the 8,000 patient 2000 VIGOR study.

http://www.nytimes.com/reuters/news/news-vioxx-journal.html

Apparently, 20 patients on Vioxx suffered from cardiac events compared to 5 on naproxen. Vioxx claimed that this was due to the protective effects of naproxen, a view now generally discarded. Now, I don’t know enough about the study or statistics to know if this is a significant finding, but it doesn’t matter. Merck apparently pulled off plenty of adequate pit-worthy hijincks in the meantime. Somehow, 17 patients were reported to have had cardiac events rather than 20, but most galling of all, the paper was apparently subject to a chop-job by some bitches over at Merck.

From the NY Times, "The Journal said Merck had submitted its manuscript both on paper and on a computer diskette, but that the Journal’s pre-publication review and editing of the story were completely on the printed version of the manuscript.

The Journal said it did not review the diskette until October 2004, several days after Vioxx was withdrawn.

``In reviewing the diskette, we learned that data on cardiovascular events had been deleted from the manuscript before it was submitted,’’ the Journal said."

So, assuming that all of this is true, fuck you Merck. Fuck you for perverting science for your own interests. Fuck investigators like Dr. Alise Reicin for engaging in this shit and then lying about it under oath. Fuck you sideways with a 1,000 count bottle of naproxen, because when all is said and done, I have a feeling that you’ll be needing it.

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Oh yeah, and here’s another good one from The Lancet.

3

Nothing to add, other than agreement that there’s something wrong when the data gets fudged.

4

I’ve come on here defending drug companies in a few threads now. I’ll even go so far as to say that I truly believe that humanity would be better served if drug companies were able to put a drug on the market with immunity from later legal suits provided they can show that they honestly performed all appropriate testing and the data indicated safety of the product. Also, I don’t think a few deaths due to drug reactions should sink a drug, provided that the companies are out in the open about the risks. Making a drug is not like making a toy; biological systems are complicated and it is very possible that something that cures me will kill you.

In short, I’m a big supporter of drug companies.

That being said, Merck appears to have really screwed up and if these allegations are true deserves what it is likely to get.

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Is this what all the hype is about? 20 cardiac episodes? That’s barely statistically significant. And besides, I was under impression naproxen, like other NSAIDS, was an anticoagulant, as such would (like aspirin does) prevent or lessen effects of a cardiac event (making it potentially go undetected).

I just don’t understand why a perfectly good drug would get pulled in a situation such as this. Couldn’t they just add a disclaimer that it might increase the chances of heart attack? I mean, Prilosec, in some people, increases the chances of getting pneumonia (a major killer of the elderly), and that’s not even on the label and it’s OTC!

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The thing that pisses me off, isn’t the number of cardiac episodes. It’s the fact that, as reported in the OP, it appears that Merck artificially lowered the number of episodes in the paper they submitted to the NEJM.

I’m still not certain the hype about Vioxx’s dangers isn’t overblown. But that’s beside the point. I’m certainly not up on all the data involved in the case.

What’s far more important to my mind is the submission of a ‘doctored’ paper to the NEJM. Anytime any corporation, student, government, or newspaper falsifies data in a scientific study it’s a serious problem. For a newspaper, or journal, this could result in a libel suit. For a student, expulsion under cheating grounds. And it seems like Merck just set themselves up for an ass reaming. By a fireplug. Sans lube.

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Exactly. Vioxx, and cox2 inhibitors in general, are fantastic ideas for drugs and it should be on the market right now. As an aside, it pisses me off that people expect 100% effective, 100% safe drugs and wonder why cures for cancer aren’t coming. The side effects of Vioxx, while severe and include death, would be an acceptable risk for many people dealing with constant pain.

But, the choice has to be made with all the information. If they hid or altered data, nomatter how statitically insignicant, that is the biggest sin in science.

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It does appear that way. Unfortunately, the “it” is 7,000 layoffs so far - with many more likely next year.

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I agree, Vioxx has some bad cardiac side effects given enough time, but so do the alternatives, and the study which provided the definitive info on its cardiac risk didn’t show any additional problems until 18 months

Rofecoxib, poor little molecule, didn’t do anything. Merck is the sinning one here, but Vioxx should certainly be on the table for acute pain or any usage under one year with a moderate dose.