Merck Knows More about Zetia than They’re Telling Us

(or How I Learned To Stop Worrying and Love the Pharmaceutical Industry)

I’d like to try to change the way you think about preventative medications.

The goal of prescribing blood pressure-lowering medications is not to lower blood pressure.  The goal of prescribing cholesterol-lowering medications is not to lower cholesterol.  The goal of prescribing medications for osteoporosis (low bone density) is not to raise bone density.  Let me explain.  The goal of medications that lower blood pressure and cholesterol is to prevent heart attacks and strokes.  The goal of medicines that treat osteoporosis is to prevent fractures.

The distinction may seem silly but is actually critical.  Strokes, heart attacks and fractures are what doctors and researches call clinical outcomes.  Clinical outcomes are things that directly affect patients, things that patients can notice for themselves.  Blood pressure, cholesterol and bone density, on the other hand, are intermediate (or non-clinical) outcomes, things that doctors can measure but that patients can’t feel directly.

The important lesson is that medicines that improve intermediate outcomes don’t always improve clinical outcomes.  There are medications that lower blood pressure without decreasing stroke or heart attack risk.  There are medications that lower cholesterol without decreasing stokes or heart attacks (like estrogen).  So the important question to ask is not “will this medicine improve my bone density?”  The important question is “will this medicine decrease my risk of fracture?”

Statins, a family of cholesterol-lowering medications which include Lipitor, Zocor, Crestor, and others, have been a boon for patients because of their proven benefit in preventing strokes and heart attacks.  Zetia, a cholesterol-lowering medicine that works differently than statins, has been proven to lower cholesterol but has never been studied to see if it improves clinical endpoints.

Last week’s NY Times had a disturbing article about Merck’s handling of data from a study about Zetia.  After completing a trial testing the effectiveness of Zetia, Merck has decided that they will only release data about some of the outcomes that were measured.  That’s definitely a reason for the rest of us to worry and for patients on Zetia to talk to their doctor.

Many of my colleagues and patients are very hostile to the pharmaceutical industry.  I’m not.  Without the pharmaceutical industry, after all, we’d never have statins.  I assume that, like all industries, they will try to sell us more than we need and will try to put the best spin on their products.  So the burden is on us, the consumers, to be educated and discriminating shoppers.

(Thanks to my colleague, Dr. Yaron Elad, for bringing the article to my attention.)

Tangential Miscellany:

A bright and happy Chanukah to all my Jewish readers!

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