More Bad News on Ezetimibe--So Why Do We Still Take It?

In the past I did several posts on the ENHANCE trial (like, http://brodyhooked.blogspot.com/2008/01/now-that-weve-been-enhanced-whats.html) that showed that ezetimibe (Zetia, Vytorin) was a flop at reducing cholesterol containing plaque within arteries.

The news this week is the New England Journal study--http://content.nejm.org/cgi/content/full/NEJMoa0907569
--in which ironically ezetimibe (Zetia) was stabbed in the back by a competing drug company, Abbott, promoting its own drug, extended-release niacin. A head-to-head trial indicated not only that niacin was better at reducing arterial plaque, but that ezetimibe actually caused plaque to increase at the same time as it was making your cholesterol lab values look better (the same as in the ENHANCE study).

The popular media is full of dire warnings from docs saying, "Just because this trial ended up badly, patients should never stop taking the medicines their physicians prescribed for them." This is despite the fact that no harm has ever been shown to come from abruptly stopping a statin or ezetimibe (which are, after all, designed to prevent fututre events and not to treat an existing disease) that I am aware of; and also despite the overriding fact that ezetimibe was approved for sale in the US despite a complete lack of evidence that it prevented any cardiac events, and based solely on the fact that it lowered cholesterol (LDL) levels by a different mechanism than the statins.

So the various lists are humming with people asking--when ezetimibe was never shown to be useful in the first place, and now has been shown in at least two studies perhaps even to be harmful as well as useless, why are people still taking it and prescribing it?

My own vote for this is the Tyranny of the Numbers.

Over the past couple of decades, Americans (physicians and the public alike) have fallen in love with the idea that you can do a blood test and get a number and it tells you how healthy you are--your cholesterol level, or now the refined version, your LDL. I served on two search committees during my previous academic job for Dean of the medical school, and we asked candidates to tell us how their general health was, and they replied, in a number of cases, without us having asked for that number, by telling us what their cholesterol levels were. As if they could reduce their entire health status to a single number. And these people wanted to be Dean of a medical school for Chrissake.

If you are totally in love with the idea that you can measure a magic number and it tells you that you are healthy, then you are equally in love with any medicine that will make that number better--regardless of what that medicine actually does inside your body. Hence Zetia and Vytorin.

I mention that hunch, in the context of this blog, simply to make the point that drug companies are smart when they market. They know that as powerful a juggernaut as their marketing machine is, they generally cannot make the proverbial silk purse out of the sow's ear (which is what we used to try to do before we decided to put lipstick on the pig). Cliches aside, you cannot make people take a drug when your message arrives completely out of left field and people have no conceptual hook on which to hang it. But if you can tie your message to something people already believe in and cherish, then you can put lipstick on the ezetimibe pig and everyone will invite it to the prom. Almost all effective drug company marketing consists of this clever hitching of the drug company message with some strain of U.S. popular culture that pre-existed the message (even if in an earlier life, drug company marketing may have helped to birth that popular culture phenomenon).