Billions wasted on cholesterol myth

by Alan Cassels

The alleged benefits of lowering our cholesterol have never materialized and we have wasted tens of billions of dollars over the last two decades, deluded by a myth. It’s time to drop that myth.

Though it may appear to my readers that I have cried wolf far too often on cholesterol-lowering drugs, I’m prepared to howl at the moon at least one more time. If you’ve read my columns over the last decade, you’ve seen me rant about the futility and absolute waste involved in our society’s collective obsession with cholesterol and our foolishness in swallowing a paradigm promoted by the pharmaceutical industry and the specialists in their employ. The alleged benefits of lowering our cholesterol have never materialized and we have wasted tens of billions of dollars over the last two decades, deluded by a myth. It’s time to drop that myth.

Ever since the early 1990s when the first cholesterol lowering drugs were being introduced to the market, no one had really ever heard of “high cholesterol” and certainly no one was going to their doctor just to get something checked that they never knew existed, that they couldn’t feel and which was responsible for zero symptoms. Then along came the blockbuster statins and physicians followed guidelines that told them a patient’s cholesterol level was an important risk factor for death by coronary heart disease (CHD). The hypothesis said that if you measured and lowered the cholesterol of patients deemed “high risk,” those patients would live longer and avoid dying from heart attacks. So how’s that working out?

Not so well, according to a study published in March of this year that probably delivered some of the boldest evidence yet and which should absolutely trash our enthusiasm for lowering our cholesterol. A European research team led by Dr. Federico Vancheri of Italy looked at statin consumption across 12 countries in western Europe between the years 2000 and 2012. During that time, the use of statins increased dramatically all across Europe – as well as in North America – yet his team wanted to know how this increase was reflected in the numbers of people who died of heart attacks. After all, with statins being used by tens of millions of patients, how many fewer heart attack deaths were there?

Here’s the good news: in all countries over that 12 year period, there was lower CHD mortality in 2012 compared to 2000; that is to say, fewer deaths by heart attack. The drop in those numbers is thought to be attributed to a range of things: healthier diets, more exercise, lower rates of smoking, better treatment once you had established heart disease, and so on.

However, things didn’t look so good when you looked at individual countries. The researchers found that “when the different countries were compared, there was no evidence that higher statin utilization was associated with lower CHD mortality, nor was there evidence that a high increase in statin utilization between 2000 and 2012 was related to a larger reduction in CHD mortality.” In other words, despite all the statin prescribing, it had no effect on the one thing we expected to see: lower rates of heart attacks. This kind of research is not exactly new. There was an earlier Swedish study that showed the differences in a large sample of municipalities where the amount of statin prescribing had zero effect on the rate of heart attacks or CHD death.

Despite this kind of bad news for the statin manufacturers, the world is not exactly mourning the loss of a very costly – and now proven wastefully ineffective – pill. Just last month, many of us watched in horror as we witnessed a high-quality source of health information – the US Preventive Services Task Force (USPSTF) – come out with the astonishing recommendation that statins should be used by even more of us.

In their analysis, the USPSTF amassed a massive amount of data from over 70,000 patients from 19 different trials. They wrote that low-to-moderate-dose statins should be given to “adults aged 40 to 75 years without a history of cardiovascular disease (CVD), who have one or more CVD risk factors and a calculated 10-year CVD event risk of 10% or greater.” Practically speaking, this means tens of millions more Americans were offered statins.

Sounds good, right? Not so fast. Remember, the people they are recommending take statins are basically healthy, middle-aged people, folks with no established heart disease, 90% of whom will live perfectly happily without a heart attack or stroke over the next 10 years. These are NOT sick people perched on death’s doorstep.

So, what’s up? It always surprises me when an otherwise reputable and trustworthy source gives absurd advice, especially given all the statin scandals and shenanigans we’ve seen over the last two decades.

In case you don’t believe me, here are some key reasons we should ignore the advice to give more statins to more people, as the task force recommended. I must acknowledge Drs. Rita Redberg and Mitchell Katz who wrote a scintillating editorial on this USPSTF recommendation and whose arguments I am partially summarizing here.

The first thing to know is that the body of studies examined by the USPSTF is tainted, as it included many people taking statins for ‘secondary’ prevention – for example, people with established heart disease and hence considered at much higher risk. You cannot extrapolate how they fared on statins to healthier people without established heart disease.

The second thing is that the evidence they looked at didn’t contain the kind of detail we need. The USPSTF didn’t examine what we call primary data, which are the actual reports from the subjects in the statin trials. Without actual patient reports, we’re only getting the results of what someone has chosen to summarize for us. Sorry, that isn’t good enough. Also, if you only examined the published reports of statins, you are being naive because we know that most of the trials on statins were done by the manufacturers and they have a tendency to bury negative data. The result? An overly rosy picture of the effects of statins.

Thirdly, there was a major bit of missing information in those data, specifically what we call “all-cause mortality.” Only half of the trials they looked at reported how many patients died from cardiovascular causes, heart attacks and strokes. The problem with missing data is you are only getting half the picture so you end up concluding the drugs are safer than they actually are. You wouldn’t conclude how rich you are by only looking at your assets, would you? No, of course not. You need to know your liabilities and debts as well. Same with statins. Without both sides of the equation, you are at risk of being misled.

We need to remind ourselves of one key thing: people of ‘low risk’ may have very little chance of benefiting from a statin, but will have an equal chance of harm. In this group of healthy, low-risk people recommended to take statins, the benefit/harm math shifts and they are more likely to be hurt than helped.

Overall, the danger of recommendations like these is that more people will be convinced they are at high risk when they aren’t and take a drug that is unlikely to help because it is only proven to help those with established heart disease. We have known for a long time that statins can cause muscle aches, weakness, fatigue, cognitive dysfunction and an increased risk of diabetes. Why would you want to take your chances?

Maybe all the statin denialism is just part of the post-truth world and people tend to believe what they want to believe despite the overwhelming evidence in the other direction. Are you a ‘low-risk’ person who still wants to take a statin? Then you should have to pay for your denialism.

Statins are currently the fourth most costly drug to BC’s Pharmacare budget, and with over 400,000 British Columbians consuming statins every day, costing taxpayers and patients about $100 million per year, couldn’t we just admit the experiment is over, it was a failure and it’s time to move on?

Alan Cassels is a drug policy researcher and writer. In each of his past four books, the latest which is called The Cochrane Collaboration: Medicine’s Best Kept Secret, he has written about statins. Follow him on twitter @AkeCassels