In our previous episode, we saw that statins – in addition to a number of other horrors – may be triggering ALS (commonly known as Lou Gehrig’s disease) in a small percentage of people taking them. Yes, the data came from an observational study, but the risk ratios are as high as those that tied lung cancer to smoking. We’re talking about people on some statins being more than 20 times as likely to develop ALS than people not on statins.
But what if risking ALS, cognitive decline, liver damage, diabetes, joint pains and permanent muscle damage just doesn’t provide that Russian-roulette adrenaline rush you want? Or what if your darned LDL just refuses to drop to an insanely low level even though you’re chugging high-dose Lipitor every day?
Modern pharmacology to the rescue!
You’ve probably heard of PCSK9 inhibitors, the newest (ahem) wonder drug in the never-ending war against your body’s stupid tendency to produce cholesterol. Here’s how WebMD describes them:
PCSK9 inhibitors are proteins made in a laboratory. They target other proteins in your body, specifically your liver.
Your liver cells have receptors that sweep away excess cholesterol. But another protein called PCSK9 destroys them. That’s where inhibitors come in. They latch onto PCSK9 proteins and block them from acting. The result: More receptors are able to do their job. This lowers the amount of LDL cholesterol in your blood.
And here’s how the makers of Repatha, one of the PCSK9 inhibitors on the market, explain why you may need the drug:
Different types of treatments are used to lower high LDL bad cholesterol. Statins are the most commonly prescribed treatment, but sometimes your LDL is still too high.
Meaning you still have some LDL in your bloodstream.
You may need additional help or a different treatment option to lower your LDL.
Oh yes indeedy, you need that additional help. Because as we all know, beating your LDL cholesterol down to almost non-existent levels will save your life.
Additional is the key word here. The clinical studies have tested statins plus PCSK9 inhibitors vs. statins plus placebo. The subjects typically have familial hypercholesterolemia, which is why statins alone haven’t reduced their LDL cholesterol scores to a level that makes doctors smile.
And what do those studies show? Here’s the money quote from a meta-analysis of several studies published in the Journal of the American Heart Association (that would be the organization that wants us all to get our LDL cholesterol levels as low as possible:
Compared with no PCSK9 inhibitor therapy, treatment with a PCSK9 inhibitor was associated with a lower rate of myocardial infarction (2.3% versus 3.6), stroke (1.0% versus 1.4), and coronary revascularization (4.2% versus 5.8). Overall, no significant change was observed in all‐cause mortality or cardiovascular mortality.
Very much like studies of statins. A slight reduction in heart attacks and other cardiovascular events, but no reduction in deaths from heart attacks or any other cause.
A reader sent me a PDF describing the results of a study on Repatha specifically. The study, named FOURIER, included nearly 28,000 subjects. Half took their statins plus evolocumab (brand name Repatha), and the other half took their statins plus a placebo.
The drug did what it’s designed to do: beat down LDL. Whereas most of these people couldn’t get their LDL much below 100 (the supposed magic number) on a statin alone, adding Repatha into the mix drove LDL levels down to an average of 30. Wow! Almost no LDL left in the bloodstream at all! Boy, that must have really saved some lives, eh?
I’ll quote from the PDF:
Myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization occurred significantly less frequently in those taking evolocumab than in those taking placebo.
Well, okay then. Sign me up. But wait … I checked the numbers and ran some calculations in Excel. I’ll skip the detailed math and cut to the chase: we’re talking about possibly preventing one heart attack in every 100 people who took the drug. For strokes, it works out to possibly preventing four strokes for every 1,000 people taking the drug.
But here’s the result that really matters:
The two groups did not differ significantly in rates of cardiovascular mortality or all-cause mortality.
No lives saved. Actually, the mortality rates were slightly lower in the placebo group – just not enough to be statistically significant.
If you’ve already heard of PCSK9 inhibitors, you’ve probably also heard they’re expensive. The PDF included a cost-to-benefit section:
The authors estimate that 74 patients similar to those in the trial would need to be treated with evolocumab for two years in order to prevent one cardiovascular death, myocardial infarction or stroke.
Um … let’s correct that. According to both this study the AHA journal’s meta-analysis, the drug might prevent a heart attack or stroke once in a great while, but doesn’t prevent any deaths. Zero. None. Again, the death rate was actually slightly lower in the placebo group. So suggesting the drug would prevent any cardiovascular deaths at all is speculative at best and dishonest at worst. Anyway, to continue:
The estimated cost of treating 74 patients with Repatha for two years is $2,149,400.
So there you have it. For the low, low cost of just over two million dollars, modern pharmacology allows doctors to treat 74 people with a drug that beats their LDL down to unnatural levels — and save zero lives as a result.
Ain’t it wonderful?