This problem is bigger than I thought...

One of the more surprising developments of the past 2 weeks has been the sheer number of people who have come by to tell us or written to us about the problems they’ve encountered with statins. That WCCO piece really hit a nerve.

And I’m getting the sense that the issue is more widespread than even I would have predicted. 

How could we in the medical community have missed something that affects so many people?

It probably goes back to the beginning.

When the large, long-term studies about these drugs first came out, side effects were reported as being very uncommon. It’s no wonder that when people started to complain about aches and pains or forgetfulness, physicians attributed those symptoms to the general ravages of aging.

But in retrospect, the studies that everyone was relying upon to evaluate for potential side effects were not actually designed to pick them up.  After all, the point of the long-term studies was to get people to take the drugs for years, so that researchers could evaluate the effects of taking the drugs on long-term outcomes as measured in rates of heart attack and stroke.

Here’s where it gets interesting.  Those studies had what’s called a “run-in period”.  That’s a fancy way of saying there was a time at the beginning of the trial when patients were being weeded out from participating further ---- because they were experiencing symptoms that might limit their ability to take the drugs on an ongoing basis.

So the people with the side effects were systematically excluded from the studies!

No wonder real-world experience didn’t match the published data.

This does NOT mean statins are all bad and that everyone is going to have problems. I need to be very clear.  At Step One Foods, we are not anti-drug. As a preventive cardiologist, I prescribe them all the time. And there are individuals who absolutely DO benefit from being on statins.  And most people taking these drugs seem to do just fine on them. Our only point is that we shouldn’t rely on a drug to fix what food can fix. Because food has no side effects. And our experience with food is vast and obviously very long term. 

The statin saga should teach us something. Doctors need to be more open to their patients’ complaints as emanating from a treatment. And pharmaceutical companies should be more forthcoming regarding what happened during a drug’s run-in period. 

Elizabeth Klodas MD, FACC