by Dr Malcolm Kendrick[I started writing this blog yesterday, following the latest guidelines on cardiovascular disease prevention launched in the US the day before… as I was writing it I found that I had to change what I was saying… read on…]
14 Nov 2013:
Rarely have I been proven wrong quite so fast. After confidently informing the world that the post-statin cholesterol lowering drugs PCSK9 inhibitors would be launched upon an unsuspecting public in the near future, with billion dollar marketing budgets, it seems that I was wrong. Although who knows, I may be wrong about being wrong.
As some of you may be aware, the latest guidelines (issued by the American Heart Association and the American College of Cardiology) on preventing cardiovascular disease were launched in the US earlier this week, with a great blare of publicity. The key message was that targets for lowering cholesterol levels are now gone.
Don’t worry about the numbers
This is how the New York Times put it:
…”First, the guidelines have moved away from achieving target cholesterol levels.
Americans have long been urged to focus on their laboratory numbers. Many people are obsessive about checking their cholesterol levels and pursuing even better numbers. Doctors have been told to focus on these numbers and, in some cases, the quality of their care was assessed by the percentage of their patients with low cholesterol levels.
Those days are over. The new guidelines recognize that for patients who have exhausted lifestyle efforts and are considering drug therapy, the question is not whether a drug makes your lab tests better, but whether it lowers your risk of heart disease and stroke. Studies over the past several years have shown that improving your lab profile with drugs is not equivalent to lowering your heart risks.”…
Don’t worry about cholesterol levels! This is a remarkable U-turn and not only that. For years I’ve been saying that the targets were a nonsense and now this is what one of the most influential cardiologists in the world, Steven Nissen, has to say about them: “The evidence was never there” for the LDL targets, he said. Past committees “made them up out of thin air,” he added.
Even more to get the drugs
What they are saying, in effect, is that lowering LDL is of no use at all. So you might think that the logical next step is that fewer people should be taking statins. Yet weirdly the guidelines row recommend that far more people start to take statins. Perhaps another forty million in the US alone. Yes, the statin meme has infected almost everyone.
You thought that statins worked by lowering cholesterol levels. Well, apparently, not any more. I have been saying for many years that the benefits of statins (small though they are), had nothing to do with cholesterol lowering – that was just an unfortunate side-effect. Now, it seems, all the American experts have come to the same conclusion. So it seems that at least I was right about that… all along.
What this means, of course, is that the new generation of cholesterol lowering drugs PCSK9 inhibitors, that I wrote about here which lower cholesterol far more than statins will have to prove that they can do more than just lower cholesterol. They will have to show some benefit on real, clinical, end-points. To put this another way… they will have to show that they prevent strokes and heart attacks…
[Sorry, hold on…]
No need to show drugs cut heart attack risk
15 November 2013… [then I read this on Yahoo news]… “Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower “bad” cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday.”
Related News headlines:
- U.S. heart guidelines threaten hot new cholesterol drugs (Reuters).
- New U.S. heart guidelines back stronger therapies for high-risk patients. (Reuters)
- US doctors urge wider use of cholesterol drugs. (Associated Press)
- Panel Unveils Shake-up in Strategy to Cut Heart Risk (The Wall Street Journal)
- New guidelines for preventing heart attack, stroke (Associated Press)
- “The statement eased industry concerns that the agency would require more onerous “outcome” studies before approving the drugs, known as PCSK9 inhibitors.”
Those concerns emerged earlier this week when two leading U.S. medical organizations recommended that doctors drop their emphasis on specific targets for lowering “bad” LDL cholesterol levels. They also recommended only statin drugs for patients at high risk of heart attack or stroke. (Link).
And so my Mea Culpa is wiped out. Although, as I did say….
‘Rarely have I been proven wrong quite so fast. After confidently informing the world that PCSK9 inhibitors would be launched upon an unsuspecting public in the near future, with billion dollar marketing budgets, it seems that I was wrong. Although who knows, I may be wrong about being wrong.’
So, I was wrong about being wrong. Which means I was right. As I knew all along.
Of course, what this means is that the latest US guidelines on cholesterol lowering state that cholesterol lowering is irrelevant. Yet the FDA is going to approve a whole new class of drugs, purely on their ability to lower cholesterol.
(Thud) Head hits desk.