Field of Science

Merck hiding negative results about drugs, again

You’d think that after the Vioxx fiasco, Merck might be a little more careful about pushing drugs that don’t offer much benefit. Well, if you did think that, you’d be wrong. A new study in the New England Journal of Medicine this week shows that two very, very profitable cholesterol drugs are pretty much useless. Merck has been at least partly aware of this for 3 years, but they still don't want to admit it – not surprising given that sales of these drugs by Merck last year totalled over $4.5 billion. That’s “billion” with a "b." Merck has also been advertising these drugs heavily since they were approved by the FDA in 2002, and it has paid off.

So what are these drugs? They’re called Vytorin and Zetia, and first of all, they’re not statins (which many of you may have heard of), which are indeed useful at lowering cholesterol. The newer drug is called ezetimibe; Zetia is the brand name, while Vytorin is a combination of ezetimibe and a statin drug. Merck makes statins too, and they have been enormously profitable, but with statins I’d say the drug makers have earned their profits (at least some of them).

What did the new study find? Well, to quote the article itself, “niacin is superior to ezetimibe”, and the NEJM editors wrote that, “the findings, obtained in a modest sample of 208 patients, followed for only 14 months, show a clear superiority of niacin over ezetimibe.” That’s right, the use of inexpensive, non-prescription niacin (vitamin B) was clearly better that Zetia. It’s worth noting that the study wasn’t measuring the rates of heart attack; instead, it measured the thickness of the common carotid artery as a surrogate, on the assumption that thickening of the arteries leads to heart attacks. But there were also more heart attacks, and more deaths, in the patients on Zetia – not enough to reach statistical significance, but perhaps that was only because of the small number of subjects. The trial was halted early when it became clear that niacin worked better, and it might be harmful to the subjects to continue giving them Zetia (ezetimibe) instead.

I found another NEJM article from April 2008 that showed that combining Zetia with statins was no better than statins alone.

So what did Merck have to say? Astonishingly (or not?), they are continuing to promote Zetia aggressively, and they issued this statement a few days ago: “"The results of the small ARBITER 6 study do not, in any way, change our view of Zetia and Vytorin as effective medicines for fighting high LDL cholesterol," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. “We encourage patients to continue taking their medication as prescribed by their physicians.” Really? The results don't change his view in any way?

This latest news comes just 3 months after Merck and Schering-Plough agreed to pay $41.5 million to settle a lawsuit that accused them of sitting on unfavorable results about Zetia and Vytorin for two years. That lawsuit was based on results released in January 2008, describing a study that ended two years earlier.

This is the kind of greedy, evidence-be-damned behavior that encourages conspiracy theorists to make wild accusations about drug companies. The problem is, sometimes their accusations are true, even if the drug companies do produce many beneficial products. One thing the U.S. should do is put a stop to direct-to-consumer marketing of drugs, ads like the one below, which claims that Vytorin is better than statins alone. Note how it doesn’t directly claim that Vytorin will reduce your risk of heart attacks, but it cleverly implies that it will:



Now that is insidious. We should never have allowed direct marketing of drugs, and we can still put a stop to it.

2 comments:

  1. Major cardiovascular events (myocardial infarction, myocardial revascularization, hospital admission for acute coronary syndrome, coronary heart disease death) occurred at a significantly lower incidence in the niacin (2/160 patients [1.2%]) vs. the ezetimibe group (9/165 patients [5.5%]). Chi-square p=0.04; log-rank p=0.047). Source: the investigators' slides, available on the AHA website.

    There were more all-cause deaths in the ezetimibe group, but I did not see a p value for that.

    I agree that these are very small numbers. But then, other cholesterol drugs are available, so why would you use ezetimibe?

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  2. The disclaimer says "you might be fucked" but the music says "everything is OK". I got to admit I love those adds! Middle aged couples, riding bicycles, while we hear disclaimers about oily discharge or four hour erections? I would miss those. But I guess the possilbe harm to patients outways the comedic value.

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