Major Rewriting of the Statin Narrative

Lipitor boxSix years ago I gave a talk at a UBCmedical school conference and I tried to do a little fortune telling.

I told the assembled medical students that by the time they graduated from medical school they wouldn’t be prescribing cholesterol-lowering (statin) drugs. I warned them that — given what we know about the very marginal effects of these drugs on lowering the rate of heart attacks or strokes, combined with their growing list of dangers — doctors would soon stop prescribing statins to their patients.

I was wrong.

Those kids have graduated and are now practising medicine, and, undoubtedly, prescribing statins. In fact in the last six years, proving my prediction dead wrong, statins have continued to sell and sell mightily. The biggest seller in the class, Pfizer’s Lipitor (atorvastatin), at its height sold more than $14 billion worth a year, the biggest revenue-generating drug in the history of the world. At one point about 10% of Canada’s prescription drug bill, roughly $2 billion a year, went to cover statins.

February was a turning point in a major reconsideration about the need to treat high cholesterol. The US Food and Drug Administration admitted in a full-scale alert to doctors and patients that statins — drugs like Crestor, Lipitor or Zocor — come with risks of diabetes, muscle weakness as well as confusion and memory loss.

We have known of these dangers for years, so why are they hitting the headlines now? That’s a good question, but suffice to say our statin love affair has been souring for some time now, largely due to the growing recognition that an astonishingly high number of people who take statins won’t see any benefit.

Last summer a high quality study, an overview of five major statin trials, showed that over a thousand people would have to take statins every day for a whole year to prevent one person from dying. Sound good? But how many were harmed in the process?

Precise rates of harm are more slippery, but some estimates say that as many as 20% of patients have the kind of muscle weakness that prevents statin-takers from doing the one thing they need to stave off heart disease: exercise.

As I pointed out to those students six years ago, high cholesterol is not the evil the pharmaceutical industry has portrayed it as, and for people without established heart disease your level of blood cholesterol is nearly irrelevant in terms of whether you’re a candidate for a heart attack or stroke.

People take statins because they are told by their doctors that their “high” cholesterol increases their risk of cardiovascular disease. Statins do “work” to the extent that they will lower peoples’ cholesterol but if those lower levels don’t translate into avoiding an early death — and actually may be contributing to other types of disability and death — what’s the point?

These drugs have been under a dark cloud for many years, and this is another sign they are in for a major rethink. As I told those students, I feel that in the future we will all look back on the prescribing of statins as barbaric and silly, similar to how we now view bloodletting, a symbol of our archaic notions of benefit and harm around medical treatments.

I wasn’t right back then, but the world is turning and with this FDA announcement, we are perhaps closer to realizing that when you give drugs to otherwise healthy people you better have very good evidence that you’re helping them.

As we continue to learn the hard way, drugs capable of doing good, are also very capable of causing great harm.

About the Contributor

Alan Cassels is a pharmaceutical policy researcher and author at the University of Victoria. He discusses cholesterol screening, among other topics, in his latest book, Seeking Sickness: Medical Screening and the Misguided Hunt for Disease (to be released in May, 2012).