If There's No Benefit, Why Tolerate Any Risk?


It is true that cholesterol is a "risk factor" in people who do not have an extraordinary family history of youngsters dying of heart disease. But it is not that much of a risk factor. If you have a particularly high LDL cholesterol (the "bad" cholesterol), and a particularly low HDL cholesterol (the "good" stuff), you are harboring a 2-3 percent mortal hazard.

That means you are at risk for living a year less than others born when you were. Very few of us have even this degree of risk. For most it is a matter of months, if you believe such a tiny risk is measurable.

It is true that these statins can lower your bad cholesterol.

It is true that maybe they can spare you a heart attack, but that's a real MAYBE.

It is also true that no study has shown it can spare me death before others born when I was born. That's true for men of my generation. There are no compelling studies for people who are not men of my generation.

Now you know why I won't let anyone check my blood cholesterol. Why bother? You can lower it, but you can't do anything for me that I would consider meaningful. I'd rather not know if I have any special risk of earlier death, even the tiny risk imparted by high cholesterol.

Merck is faced with a class action law suit because its advertising allegedly suggests benefits from Lipitor for women when there is no supporting science. I don't think there are benefits for anyone in the general population.

I have never prescribed any drug of this class.

Caveat Emptor (Buyer Beware)

I have written commentaries for ABCNEWS.com relating to the lack of benefit from stents and mammography. I will not reiterate these since they are readily available in the archives.

The lesson is obvious. We, all of us, need to demand that no drug be licensed without a demonstration that it is meaningfully effective.

Today, the game is to generate evidence of any effect. We should demand much more than evidence for a surrogate effect such as lowering cholesterol or lowering blood sugar. We should demand more than evidence of an infrequent benefit that is not that crucial. We should demand robust evidence for a meaningful effect.

Then these tiny, remote harms would be countenanced.

Then all the hype, the "me too" drugs, and the profitable silliness would be dark history.

Then we would all be better off.

Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. He is the author of The Last Well Person.

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