Cholesterol Guidelines and the Bachelor with Platform Shoes

(My very first blog post in 2008 on my WordPress blog "A Country Doctor Writes")

I have read that tall bachelors have more dates than short ones, and until recently it seemed obvious that men with low LDL cholesterol would have fewer heart attacks than men with higher levels. So what happens when a vertically challenged young man dons a pair of ABBA style platform shoes? And what does this really have to do with cholesterol?

Let me start from the beginning.

In medicine today, there are two mantras, even buzzwords: Evidence Based Medicine and Clinical Guidelines.

To practice Evidence Based Medicine is to do precisely those things that are proven by rigorous research to help the patient. Examples include giving heart attack survivors certain medications (Beta Blockers) or to give aspirin to patients with TIA’s (often called “Ministrokes”).

Clinical Guidelines often involve reaching numerical targets, and this is the first tip-off that we’re on much shakier ground. Keeping a diabetic’s blood pressure under 130/80 may be a good thing to do, but not if the person has a history of fainting from low blood pressure when standing up too quickly.

A dramatic example of failed guidelines came with the recent publication of the ENHANCE study (New England Journal of Medicine, April 3, 2008). The National Cholesterol Education Program has long recommended keeping the bad LDL Cholesterol under 70 in high risk patients, like those who have had a heart attack or a bypass procedure. The problem with this guideline was that it created a situation where doctors faced with an LDL slightly above “target” would abandon high doses of, for example the proven drug Lipitor, and switch patients to moderate doses of Vytorin, which contains a less powerful “statin” drug and an until now unproven new drug, called ezetimibe (Zetia).

The new drug, introduced in 2002, lowers cholesterol by blocking intestinal recycling of old cholesterol from the body’s different cholesterol-based hormones etc. In the beginning, there was no proof that ezetimibe lowered heart attack rates or limited cholesterol buildup in our arteries, but there was something very promising about the drug; it not only helped lower cholesterol, but it also reduced levels of CRP, or C-reactive protein, an inflammation marker that closely follows heart attack risk.

So the number crunchers started to put pressure on doctors to reach numerical targets, and television ads promoted the dual action of Vytorin.

Fast forward to a couple of months ago when, after a billion dollars in sales, the new drug looks no better than platform shoes; better measurements, but same number of dates (in this case meeting our maker…), so to speak. The ENHANCE study didn’t count deaths or heart attacks, but it did measure thickness of cholesterol buildup in arteries, and there was no difference between plain Zocor (simvastatin) and the combination drug (Vytorin). Factor in that you can buy simvastatin for $4/month at some supermarket pharmacies, while Vytorin costs 2,500% more (yes, do the math; $100 divided by $4 times 100%!).

The lesson here is that the guideline writers failed to think about what evidence we had about how patients achieved their goal numbers, just like the guy in the ridiculous shoes only thought he was closer to eye level with the girl he was trying to impress.