PHARMA: The statin backlash (or WSJ later than THCB by 5 years!)

Yesterday the THCB hit meter went off the charts. not sadly because of some new genius posting on THCB, but because the WSJ has this article about Lipitor causing memory loss and Google searches are bring up an article from 5 years ago on THCB that I wrote—after reading a piece in Smart Money about the same topic. Here was the key paragraph form that article

Unfortunately the Smart Money article doesn’t give any denominators, so there’s no real evidence other than these anecdotal stories about whether significant numbers of people have had these reactions to Lipitor.  So despite the heart-rending stories, you can’t draw any conclusions. Also don’t forget that in the grander scheme of things (if you believe the conventional wisdom that lower cholesterol reduces heart disease), Lipitor is saving thousands of lives for each one it hurts–if it does hurt.

The problem is that increasingly it’s become evident that the statin story is similar to other heart intervention stories—the endpoint which it helps (lower cholesterol in the case of statins, less heart blockage in the case of CABG and stents) doesn’t necessarily reduce overall mortality all that much on an absolute risk basis—and may have other damaging side-effects. Of course the most under-reported side effect from CABGs is also neurological deficiency. In fact there are serious clinicians who believe that use of statins or revascularization prior to a heart attack is clinically wrong.

So it appears that we know far too little about what’s going on before we really should be putting statins “in the water” as the cardiologists use to joke.

Then of course there’s the business interests involved. Pfizer has been roundly criticized for its Lipitor off-label marketing (even if going after Robert Jarvik for his lack of rowing skills is a little silly). But the pressures around a $12 billion franchise are likely to create this kind of behavior.

And worse. Peter Rost (not exactly Pfizer’s best buddy) has been pillorying Schering Plough for the stock trading behavior of its senior execs before recent belated release of data on the failed Zetia trial. And now Congress is joining in there too.

All of which gives me  pause to think about whether the whole statin era may be on its way out. It’s looked so obvious for so many years that more people should be on them, but maybe the pendulum of the perception of the evidence is starting to swing the other way.

And when you read a message board like this one at DailyStrength, it certainly gives this 44 year old with borderline high cholesterol pause before wanting to go down the statin path. Still I guess Feb 14 is an appropriate day to be confused about affairs of the heart!

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2 replies »

  1. This statin conundrum reminds me of the old days when AIDS was first identified as a clinical syndrome but its cause was unknown. At the time, the American Red Cross stated positively that there was no evidence it could be transmitted by blood transfusion and therefore “directed donor” transfusions were to be discouraged. (I was a community hospital pathologist trying to deal with panicked patients; that’s why I remember this.) Their viewpoint was shared by most medical authorities, but there was a “radical” group at San Francisco hospitals which dissented – in retrospect, probably due to their higher caseload and therefore greater clinical experience.
    Well, guess who was eventually proven right??
    I think this just illustrates that sometimes only the tincture of time and additional research tell us what helps and what harms. In the meantime, we all struggle – patients and doctors alike.

  2. I’ve always found it humorous that statins became multi-billion dollar drugs even though no one knew how they worked. Oops..it isn’t the cholesterol-lowering effects of statins that make them miracle drugs, it’s the totally unforseen anti-inflammatory effect.
    I was the TV medical reporter for CBS in Chicago for many years. (Now I run a large physician marketing company)I interview many cardiologists laughing about “putting statins in the drinking water.”
    I was skeptical of the financial incentives then…and I’m even more skeptical now.