Cholesterol: I’ve never been wrong so fast or so right

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.

Dr Malcolm Kendrick

Dr Malcolm Kendrick

Dr Malcolm Kendrick – a GP in Lancashire – is the UK’s most determined and informed critic of statins – The Great Cholesterol Con - as well as other medical obsessions such as health checks and mammograms. He campaigns for a more balanced approach to health at drmalcolmkendrick.org

17 Comments

  • It’s OK, statins are not for lowering cholesterol. They are for stabilising Carotid plaque. At least that’s what my doctor told me when I asked to come off them because I didn’t want to lower my cholesterol. Four months later I was asked to go back on them because my cholesterol levels had gone up. Dear Medical profession, if you’re going to make stuff up, at least let it be consistent!

  • You’ve been proved correct (congratulations: very well done) on the cholesterol con. But the statin con continueth. As for the forthcoming (pesky-nein!) drugs, what can one say? Is it a case of intellectual confusion, bureaucratic blundering, or financial corruption?

  • I do hope that you don’t hold back from rubbing it in, Dr K.

    Here’s more ammo.
    http://www.nytimes.com/2013/11/18/health/risk-calculator-for-cholesterol-appears-flawed.html?_r=0

  • S tay
    T aking
    A torvastatin
    T o
    I njure
    N eedlessly

  • I reckon the cholesterol calculator malfunction is just a red hearing so to speak, designed to deflect the fact that the LDL number isn’t important any more despite previous insistent that it was, it’s also deflecting from Pharma next big win, PCSK9 inhibitors, which are the next blockbuster class of anti-cholesterol drugs. It’s quite possible the US FDA in its infinite wisdom will not require the makers of these products, to prove that they save lives, just that they lower LDL cholesterol, which will only further pollute the dialogue about risk reduction.
    Even more important, PCSK9s are injectable products, which means physician visits and, if the real world clinical conditions mimic trials, patients will need antihistamines, acetaminophen, and oral corticosteroids to manage side effects.

  • I think what the guidelines actually said was that, because the studies used as the basis for the guidelines used fixed doses of statins rather than targetting a LDL level, they couldn’t tell how much to recommend lowering LDL, but by lowering LDL with statins there was a benefit.

    There’s still ample vagueness there to claim they believe in lowering LDL, they just don’t know what is an optimal level, but reducing it is beneficial so take a statin. It’s not going to stop marketing PCSK9 inhibitors.

  • I am not on statins though my cholesterol is just under 300. I am wondering what is appropriate to be doing to avoid heart disease.

    I am 65 yrs old and as far as I know, don’t have any disease of any kind.

    Thank you.

  • Richard Belloff….Enjoy that Cholesterol, which is present in EVERY CELL in our body, it is so essential, our bodies MAKE CHOLESTEROL. By blocking Cholesterol production, you are also blocking Vitamin D, Testosterone, Dolichols, and dozens o other molecules our Body was designed to MAKE.

  • I told my GP that I refused to take statins again as I felt so ill the previous time. After trying to badger me because my TC was 9.3, and getting a firm no, she prescribed Ezetimibe which she said was not a statin, but did the same job. Anyone know whether this is worth taking, or just as bad as statins. Can’t find out much online apart from manufacturers hype. I’m 69 by the way.

    • Editorial

      This a bit late but I’d seriously recommend avoiding Ezetimibe as it is a classic example of ability of “evidence based medicine” advocates to ignore the evidence when it suits.It is also an embarrassing drug for those who believe that cholesterol is a factor in heart disease.

      Introduced in around 2002 with a big fanfare it certainly lowers cholesterol when added to a statin – via a different route. While statins cut cholesterol production in the liver, it cuts absorption in the gut. Ezetimibe was licensed on the basis that it lowered cholesterol on the assumption that bringing down bad cholesterol must cut your risk of heart disease.

      Problem was that all subsequent trials failed to show that it had any impact on heart disease at all. It is now off patent, and so cheap, but it it was still prescribed on the NHS at a cost of around 70 million a year. Not only was that a scandal but the implication of its failure – also blithely ignored – was that what benefits statins had on heart attack risk had nothing to do with cholesterol lowering but was due to the drugs’ ability to lower inflammation. The situation sounds ludicrous but I promise I am not making it up. For more details and references and all see: https://jeromeburne.com/2013/03/04/the-evidence-free-drug-that-costs-the-nhs-70-million-a-year/

  • At 69 years of age (and particularly being a woman), you should be absolutely delighted that you have a cholesterol level of 9.3. Ask your doctor to confirm that the higher your cholesterol, the longer you’re likely to live.

    Just do a search for “high, cholesterol, longevity” etc.

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