Statins for everybody?

Statins like Zocor, Lipitor and Crestor have been around for decades. They lower your cholesterol level.

They have been around long enough that they are in the process of going generic. Zocor is simvastatin. I use it. Lipitor is atorvastatin. It will be a generic next year.

The generic name for Crestor is rosuvastatin. It is under patent through 2016, although a coalition of generic makers are now in court trying to bring that date up.

Until now you have been told to take statins only if your cholesterol level is high, roughly 200 milligrams per deciliter of blood. It is a simple test patients take every six months. (I get my next one next week.)

Now, thanks to a study called JUPITER, the FDA is approving use of Crestor even in normal middle-aged people, to prevent heart attacks and stroke.

JUPITER was a company-sponsored study -- it stands for Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin. (Drug companies like snappy acronyms the way computer companies like words with Xs and Zs and Qs without Us in them.)

The fact this was a company-sponsored study, and the authors had many, many conflicts of interest, are troubling to critics, but the result was clear.

Eat all you want, we'll make more.

JUPITER claimed heart attacks dropped 54%, strokes 48% and the need for operations opening up arteries by 46% among statin-eating old-timers, compared with those who didn't take the meds. (By old-timers I mean men over 50 and women over 60.) Those are big numbers.

The FDA has been on the road to this decision for 14 months, since the results were published in the New England Journal of Medicine.

This is a big deal. The last major event in statin marketing came decades ago, when the makers of Lipitor got the bright idea of testing their drug at higher dosages. When they found it well-tolerated Lipitor zoomed past Zocor and became the number-one statin in the market.

But in a follow-up study Lipitor was also found to reduce heart attack risks, which led Astra-Zeneca to pony up for JUPITER.

There remain some big questions:

1. When a study shows one statin has a specific effect, does that mean all statins might have it? The drugs are similar.
2. Is the purpose of these studies to save lives or to just extend patent protection and profits? Funny how these studies come out when sales need a boost, when patent end dates are approaching.
3. What about side effects? There are side effects from statins, usually (not always) minor, but if everyone is taking them won't we soon find people with really bad side effects?
4. What about the cost? Patients saved billions when Zocor became simvastatin. They are due to save more when Lipitor goes generic. Crestor is presently patented through 2016. Will vast new patient populations now be pushed toward a name brand drug?

Just as the statin industry has grown, so has the anti-statin industry. There have been studies that came out negative for statins. Some call the whole issue a con.

Personally I don't think so. My dad had his first heart attack at 47, before statins were developed. When I got checked at age 45, I had a cholesterol count of 373. One of my neighbors died of a heart attack recently at 44, before he could get his cholesterol checked.

The danger is real.

But does everyone face it? The JUPITER study says yes. The FDA says yes. Which means your doctor will soon be told to say yes, too.

Are you going to say no?

This post was originally published on Smartplanet.com