The Cholesterol Controversy, or Are We Getting Fleeced by Statins?

5 billion a year, according to this wellness site that I found with a Google search, is how much the big drug companies are fleecing the public for. A lot of this flap came from the 'failed' Vytorin study, which is unpublished but findable in the Medical Letter here, and in a statement from the American College of Cardiology here.

The study was a randomized trial of people with Familial Hypercholesterolemia and showed no difference--actually, Vytorin was less effective than simvastatin--in slowing the growth of plaque. Forbes said their stock tanked. The wellness site above points to it as evidence that lowering cholesterol is a farce (and, of course, we should buy his book).

The Health Beat blog, which I like but which appears to have a bias against pharma, takes on the topic here. For a bit, I felt betrayed. Here I had been talking to people about lowering their LDL and treating cholesterol for weeks, and the dogma is that statins as a class are being used more and more, not less.

We've been looking at pictures like those at right for years of medical school, learning how to treat it with drugs. Don't they work? Well, actually, yes. Let's talk about endpoints. There is a big study in the Lancet in 2008 (PubMed ID 18191683 at pubmed.gov) that was a meta-analysis of 18,686 diabetics which supported a reduction of 1/3 in major vascular events.

A 2006 study in the Archives of Internal Medicine (PubMed ID 17130382) showed a reduction in major vascular events with NO reduction in all-cause mortality. There was, of note, a 14% reduction in the incidence of stroke.

Critics, including Health Beat, argue that lowering LDL numbers do not affect all-cause mortality and therefore are not useful as there is no quantifiable evidence that quality of life goes up, and there are side effects to statins. True. Also, the Lancet article in particular is a meta-analysis of industry-funded studies, which it admits.

Still, large meta-analyses are about as trustworthy as evidence-based medicine gets, and many drug studies are industry funded.

Are statins a fraud? Just money? A plot by Big Pharma to fleece us of billions?

Of course Big Pharma wants to make money, and tons of it. It is the fundamental mission of private companies to make lots of money and they should. No one should have any illusions about that. This perhaps goes towards why we should have a public health care system. But I digress. The question is if people were fleeced, should ask for their money back, were betrayed, and so on. The wellness sites and others point out that lowering cholesterol naturally with diet and exercise is a better way to do it and statins are a rip-off.

Guess what? We tell our patients that. We say, you should lose weight, eat right, and exercise. A lot. Now. And how many do? In six weeks of primary care, I saw TWO people who had done that. They were healthy, happy, had great numbers and a very high quality of life. We encouraged them, held them up as examples. TWO of them.

So should we avoid treating with statins? If I have a person who, for whatever reason (perhaps because they're a tad lazy) can't lose weight, watch their saturated fat intake, or exercise, should I tell them to just go away? Umm...no. Should I avoid giving an elderly, male, smoking, diabetic a drug that might reduce his chances of having a stroke because he SHOULD quit, eat greens, and run a marathon? No. I'll tell him that every visit. But guess what? He just might not listen.

We should accurately represent what statins do: they make a noticeable difference in the risk of a cardiovascular event, but it is mild. It's not a miracle cure. You should stop if you get muscle aches and so on.

But call them a con and a fleece? Western medicine has said all along that patients should eat right, exercise a lot, not smoke, lower their stress level, and so on. It's easy to jump on the statin 'push' and say doctors and the medical establishment are just in it for the cash, because it absolves all those sedentary junk-food eating patients of any responsibility for their terrible disease burden. As an added side bonus, it often helps sell diet books and alternative medicine, which as far as I know, doesn't come with a money-back guarantee, either. Far from it.

OF COURSE Big Pharma wants to make money. Most doctors (I admit, not all) want to help patients. And we figure that even those people who choose not to modify their lifestyle deserve some recourse to try and prevent badness. Crazy us.

To close the circle, let's go back to the Vytorin study. The drug failed to beat simvastatin with regards to thickness of plaque in people with FH, a rare genetic disorder. So, the endpoint doesn't matter (mortality, heart attacks, and strokes matter) and the population is not applicable to every patient. Is it disappointing? Sure. Does it mean statins don't do anything? No. Patients and doctors shouldn't rely on them to get them out of the work of modifying behavior.

There is no quick fix.