Here they come – take cover

Apart from Rosuvastatin/Crestor, all the statins have lost patent protection, and so the world has changed. I probably need to explain a bit about Patent Protection. If a pharmaceutical company discovers a new, potentially beneficial chemical/drug, it can claim patent protection for twenty two years from the date of first registration of that new chemical compound. Then the clock starts ticking.

So you need to get going to do all sorts of testing on your new chemical to make sure that it actually does something considered useful e.g. kill bacteria, or attack cancer cells, or control progression of rheumatoid arthritis. You also need to ensure it doesn’t kill people, using the sort of doses you would give to achieve a clinical effect. You should ensure that it doesn’t react badly with other commonly used drugs, and on and on.

This all takes time, and costs a lot of money. Companies tell you it costs hundreds of millions to get a drug to market, perhaps even a billion, but their figures are always held tightly to their chest. It certainly costs a lot. How much exactly…no idea. As for the amount of time? Probably about eight to ten years from discovery to launch.

After launch, the companies then have around twelve to fifteen years to sell the drug as hard as they can, whilst they have an effective monopoly. During this window of opportunity they can fix the price wherever they like. This is usually bang on what medical systems think they can afford, or just a sneaky bit more. ‘Oh go on, you know you want it.’

However, once patent protection is gone, generic drug manufacturers that have been waiting in the wings like vultures, can make that exact same drug and sell it, in competition with the company that discovered the drug in the first place – or any other company that wants to make it.

Because generic companies have not had to go through the hugely expensive drug development process, their costs are much less, therefore they can afford to sell the drug far cheaper and still make money. At which point the big companies such as Glaxo, or Pfizer lose interest. Their business model requires enormous profits to support their equally enormous overheads. Selling drugs at a 5% margin is not what they do. They have a workforce of tens of thousands to support.

Getting back to the point in hand. Statins are now, effectively, out of patent. They were the most profitable drugs in the history of the pharmaceutical industry. Lipitor/atorvastatin made tens of billion dollars in profit each and every year it was in patent, and turned Pfizer into the biggest drug company in the world. But statins are now cheap as chips.

Various attempts have been made to combine statins with drugs such as ezetimibe and carry on the patents – you get extra protection for combinations. A few billion has been added here and there. However, the seam of gold has effectively been hollowed out.

So what to do? Shrug your shoulders and move on to a different therapeutic area. Or…? Over the years, billions upon billions have been spent making the statin market into something absolutely massive. This market could also be described as the ‘cholesterol lowering market.’ Everyone, or just about everyone, knows their cholesterol level. They have been trained to be terrified of having a high cholesterol level, and they want it brought down. Bell rings, dog salivates.

In parallel with successfully raising the spectre of having a high cholesterol, the level of cholesterol considered ‘high’ has also been inexorably driven down. Years ago a high level was something over 7.5mmol/l (~300mg/dl). In Europe anything about 5.0mmol/l is now consider high. In the US it is 5.2mmol/l, otherwise known as 200mg/dl (the US and the rest of the world use different units of measurement). However, even that has been further lowered. In those at ‘high risk’ the cholesterol level needs to be below 4.0mmol/l.

The average cholesterol level of human is about 5.5mmol/l (very broad brush stroke), which means that we find ourselves in the weird, yet unquestioned situation, where around 85% of the entire population of the world is now considered to have a high cholesterol. Boy that is some market. Almost every one alive, and with a pulse, should be taking a statin. And people almost demand them ‘I must get my cholesterol level down, now!’

As a pharmaceutical company you certainly do not want to walk away from that, the land of milk and honey…and money. A perfectly prepared market, desperate for anything that lowers cholesterol. Even gaining one percent of that market would mean about twelve million people worldwide… in counties rich enough to pay. If your drug costs a thousand pounds, dollars, or Euros a year, that is still twelve billion pounds dollars or Euros each and every year. Twelve billion profit a year. Be still my beating heart.

And to access that market, all you need to do is to find another way of getting cholesterol down. [Using new drugs that can be patented, and sold at a price that makes a whopping profit]. As a quick aside, the HDL ‘good’ cholesterol raising agents all crashed and burned before you ever knew they existed. They raised HDL and also raised the rate of death from heart disease at the same time. Ooops. So maybe HDL isn’t ‘good’ cholesterol after all. Shhhh, let that be our little secret.

So the industry looked around, and studied everything they could, and they have come up with Proprotein convertase subtilisin/kexin type 9 inhibitors. However, you must ensure that you don’t ever call them that, or everyone’s eyes will simply glaze over followed rapidly by sleep. So this moniker has been shortened to PCSK9 inhibitors. Very catchy.

How do they work? Put as simply as I can. Low Density Lipoprotein (LDL) a.k.a. ‘bad’ cholesterol I is removed from the circulation by binding to an LDL receptor, which is then pulled into the cell. The LDL is ‘unpacked’ and the receptor broken down by PSCK9. However, if you block PCSK9, the receptor lives to fight another day. It is sent back out to the surface of the cell, binds to LDL again and pulls it in. With more and more receptors waving about, the LDL is more rapidly removed from the circulation and the ‘cholesterol’ level drops.

It is true that if you give people a PSCK9-inhibor the LDL/cholesterol levels certainly drop very dramatically. Even more so than with statins. Hoorah! LDL levels can reach virtually zero. Hoorah! Drool! Kerching! As you might expect, a number of pharmaceutical companies have decided to develop their own, very slightly different versions, of PCSK9 inhibitors, and they will all be launching shortly. The one hitting Europe and the US first is likely to be Praluent. Made by Sanofi and Regeneron. It will be given a more catchy brand name when it launches. Cholestegon, or something of the sort.

Of course the hype is going to be monstrous. Newspaper front pages will hail these drugs are life savers, super-statins, Governments must fund them, blah, blah, blah. Billions upon billions will be spent marketing them. Well, you have to speculate to accumulate don’t you.

Experts a.k.a. rent-a-quote dancing bears will do their thing…. ‘Roll up, put money in the jar and the bear will sing and dance any tune you like…’ Yes, experts will dance the tune, and sing the songs required of them by the industry….kerching, kerching, kerching, ker-bloody-ching. ‘Why can’t I see my reflection in the mirror any more mummy?’

Papers will appear in journals that will be reproduced, and repackaged, to be presented to doctors; giving all the scientific reasons why PCSK9-inhibitors need to be used. There are, however, one or two little problems to be resolved.

  • Statin hype
  • Cost
  • Injectable
  • No outcome data

Statin hype

Having spent billions convincing everyone that statins are uniquely effective, have no side effects, and also cure cancer, bacterial infections, HIV, the Ebola virus, bad breath, poor conversational ability, and other things too numerous to mention, your main competitor is the ‘wonder’ drug you created in the first place. Which is also now very cheap.

So, dear pharmaceutical companies, you are going to have to attack statins to create some space in the cholesterol lowering world. We can already see this happening, with sad looking ‘experts’ confirming how terribly disappointing it is that some people just cannot tolerate statins…when I say some, I mean about 25%. ‘But I thought you said statins had no adverse effects.’

Expert: ‘I know, that is what I once thought, but it seems…sob…that many patients have difficulties…sob. Sorry, I am very emotional about all this.’

Pharmaceutical company executive whispers:It’s OK, you can have your money now. There there, don’t get so worked up. You can have your swimming pool.’

Cost

Statins now cost about thirty pounds a year. PCSK9 inhibitors will be in the region of five to ten thousand – so I have been told. If so, health authorities are going to be very, very, unhappy. They will see budgets spiralling out of control. This could kill these products stone dead in many countries. However, the companies will be very careful to ensure that they will only be looking for them to be used in a very small sub-set of high risk, statin intolerant patients. [And if you believe that, you will surely believe anything].

Injectable

These drugs impact on processes within the cell nucleus itself, so they are monoclonal antibodies. They cannot be taken orally, as they would be broken down in the stomach/gut, so they have to be injected. Every two weeks or so, you will need to have an injection. This can be painful and also inconvenient. This will limit uptake. Then again, some people believe that if you inject something, it must be more powerful.

No outcome data

Whilst PCSK9 inhibitors definitely lower LDL, there is no data on their effect on cardiovascular mortality, or any other form of mortality either. They are launching purely on their cholesterol lowering ability. A surrogate outcome. This, of course, saves the tiresome and costly requirement of demonstrating that they actually work. But it may make it rather tricky for them to gain full approval without any proof of efficacy. Or maybe not.

Despite the problems listed above these drugs are coming. Will they be a success? Well those working in pharmaceutical companies are not stupid. They would not be spending billions unless they were pretty certain of success.

What will success look like? Well, frankly, I am sure that they would be happy with one percent of the population taking PCSK9 inhibitors. That would be about three million in the US, four million in Europe, five million in the rest of the world – in countries that have enough money to pay. This is a total market of one hundred and twenty billion pounds/dollars a year. Not bad. Three drugs sharing one hundred and twenty billion is forty billion each, per year, for fifteen years. That is $600Bn lifetime drug earnings.

If they were to succeed in squeezing the market up to ten per cent, that would be a market of one thousand two hundred billion a year. Greater than the GNP of almost every country in the world, up to about Canada. My guess is that they will get to about two to three percent. This market will consist of those with very high cholesterol levels who are ‘statin intolerant’. Yes, be ready for the phrase ‘statin intolerant’, it is how those poor unfortunates who cannot take statins due to adverse effects will be described in future.

Speculating wildly, if they did manage to get everyone on a statin to convert to a PSCK9 inhibitor then the entire GNP of nations would be gone. In the UK, twelve million, or so, are ‘eligible’ for statins. Twelve million times ten thousand is one hundred and twenty billion pounds. That is slightly more than the entire budget of the NHS. Money well spent?

You have been warned.

126 thoughts on “Here they come – take cover

  1. nnmlly

    Thank you, Dr Kendrick. You are the ultimate bullshit-busting blogger. I love your work. I am doing my best to coerce everyone that I know into reading your Doctoring Data book. My Dad binned his statins based on my second-rate description of the tome.

    Reply
  2. lindaccd

    Pnightingale100@btinternet.com 

    Sent from Yahoo Mail on Android

    From:”Dr. Malcolm Kendrick” Date:Sun, 26 Jul, 2015 at 8:01 am Subject:[New post] Here they come – take cover

    Dr. Malcolm Kendrick posted: “Apart from Rosuvastatin/Crestor, all the statins have lost patent protection, and so the world has changed. I probably need to explain a bit about Patent Protection. If a pharmaceutical company discovers a new, potentially beneficial chemical/drug, it can”

    Reply
  3. Dr. Göran Sjöberg

    So well phrased about what is at the heart of the cholesterol matter.

    Logic of greed but not of physiological science.

    For a sunday morning I now appropriately happens to read what my favourite philosopher Schopenhauer is writing about ethics and I find him very convincing when he refutes Kant’s famous categorical imperative about ethics as nonsense. Schopenhauer’s standpoint is here that greed is the baseline norm in society but that it certainly exist individual exceptions who work not for their own interests but for the ‘good’ of the society.

    These exceptional guys are worth all our praise, especially on sunday mornings.

    So, Cheers to you Malcolm!

    Reply
  4. Sylvia Brooke.

    Interesting news Dr Kendrick. Thank you for the advance warning. I just wish I understood some of the ‘medical speak’ a little better.

    I stopped taking statins some time ago following discussions on this blog, and feel much better for it, but can see the subject being brought up yet again the next time my cholesterol level is mentioned (7.3 by the way). I know what my answer will be.

    By the way, I love your blog. It’s good to know that somebody cares.

    Reply
    1. David Bailey

      Sylvia,

      My doctor and I agreed that since I was not going to take a statin ever again, there was no point in the NHS wasting money measuring my cholesterol level! You might propose the same arrangement.

      Reply
      1. Sylvia Brooke

        Oh, that’s certainly a thought David. I never considered an official ‘opt out’. I have seen two Consultants at hospital since I stopped taking statins, and they both recorded that I could not tolerate them for various reasons, but neither made any further comment. I imagine that that may put me in line to be offered the new drugs as they become available, but if I did what you suggest it would certainly prevent any further aggro. We shall wait and see!

      2. celia

        My answer would/will be that I am not only ‘intolerant of statins’ I am intolerant of having my cholesterol levels lowered by any means. I would also add that my research indicates that old people with higher cholesterol levels live longer. As far as I’m concerned that’s a good enough reason to refuse cholesterol lowering agents of any sort.

  5. Jennifer

    My statinised TC pottered along at 3.4 and I probably had a nice gold star on my medical notes.
    Trouble was….I was an unhealthy wreck….but no one, except me and hubby noticed…..all were too busy looking at the computer screen, I recall.
    In anticipation of being targetted by my GP to take these new toxins, to replace the statins I stopped, [I came off statins due to their monstrously disabling side effects …..all in my head, you understand (!)], then my solution will be to steer clear of the medics as best I can.
    Dr K, thanks for the warning…I will be on my guard.

    Reply
  6. Tom Welsh

    Yes, it’s very unusual to find any single person with the intelligence to understand such complex matters fully, the creativity to think about them in new and unconventional ways, the courage to stand up and shout that the conventional wisdom is wrong (and perhaps incited by greed) – and, last but not least, the literary skill to turn business and biochemistry into gripping, amusing drama.

    In a properly run world, Dr Kendrick would at least be offered a dukedom. (Although I suspect he might refuse it!)

    Reply
    1. Janet Beach

      Keka – I think there are a lot of us who feel the same way. I wonder if Dr. Malcolm Kendrick could be cloned……………

      Reply
  7. Elaine

    Once again you have hit the nail on the head, but how many of your colleagues will be brave enough to speak out against Big Pharma. The drug bill is already bankrupting the NHS – these drugs will be the final nail in the coffin!

    Reply
  8. Flyinthesky

    All the time I’m reading the post I’m thinking that in order to maximise the sales of the new wonder remedy the old one has to be discredited, and voila! at the paragraph heading statin hype, there it is.
    This is going to be a tightrope walk for them and very carefully managed.

    Reply
  9. Sean Coyne

    Brave man, I’d change my name and go into hiding after that burst of truth, but then I’d outdo ma wee dog in the lack of bravery stakes, Seriously, if what you say pans out, they will go after you. Go on man, do your worst, prescribe then statins. 😉

    6.5, eating a steak tonight, sipping a whisky, all the while keeping calm and carrying on.

    Cheerypips and have a dram yourself!

    Reply
  10. Chris harvey

    Dear Dr Kendrick,
    You are indeed a prophet. On Friday I see that the FDA approved Praluent, and in “Le Monde” today there is a headline about Sanofi’s access to the bonanza at 40$ a shot. Luckily it lowers the “bad” cholesterol!
    Question: Why did God endow us with bodies to fabricate something so bad for us?

    Reply
  11. Neil

    I was 6mnths on statins and they hurt like hell. I told my GP and she said “You want to stop taking them?”. I said “Yes”. “OK” says she. And that was that. No argument, nothing. Then I start reading articles about statins and found Malcolm’s site. It’s obvious ALL the doctors know they’re a lie otherwise they’d be pushing me to stay on them. Thank you Dr Malcolm!

    Reply
  12. Marjorie Daw

    Is it too late to buy stock? If you can’t lick ’em join ’em.

    Malcolm – great article but you have an unusual number of typos.

    Reply
  13. Brian Wadsworth

    I see a brilliant career ahead for you in a pharma company if you could only suppress your ethical and moral standards. You seem to have the game plan all worked out.

    Reply
  14. Ellien

    Ho ho ho – time to buy shares in those pharma companies. On second thoughts, maybe not, my conscience will not allow it. Thanks for yet another exposure of the treachery involved in the pharmaceutical world of business and profits. And think of all those who will complain because the local NHS board will not approve of the new meds except for those who are deemed “statin resistant”. Never mind the cost to the taxpayer – you and me and everyone. And think of the blackmarket in approvals for these new meds – oh, it will be a field day for unscrupulous doctors who pocket a few bribes in the process. Ho ho ho.

    Dr. Kendrick, could I trouble you to say a bit more about what appear to be dangers involved in having a high HDL. I’ve always been led to believe that it is the ratio between HDL and LDL that matters – Dr. Mercola says it needs to be 2.5 LDL to 1 HDL to be OK, not so much what the actual levels are. Do you have a take on this, please? My HDL is high at 75 – is that a problem?

    Reply
    1. Flyinthesky

      I find the best way to overcome the cholesterol problem, heresy I know, is not have it measured, worrying about it will probably do you more harm than having it.

      Reply
      1. Jennifer

        Flyinthesky. Exactly!
        We have been hard-wired over the years to think that we MUST know
        our cholesterol number…..but what the devil for?
        Unless we are thought to have familial hypercholesterolemia (1 in 500) there is no need to know! And, indeed, it remains contentious that even that condition is deleterious to health.
        Measuring cholesterol is based on the false premis that healthy folks need to change their level…. and be it high/low, and needing to go up/down, depending on the stance our medic takes, be assured that big pharma will find some way of making money from the information. Scandalous.

  15. Sylvia Foxcroft

    I live in Cheshire and oh how I wish you were my GP!

    Brilliant article and long may you continue writing them.

    Reply
  16. Janet Beach

    I believe it’s the HDL/triglycerides ratio that’s important. High HDL and low triglycerides means everything is hunky dory….I hope, anyway.

    Reply
  17. S Jones

    To anyone from the UK complaining that their GP will lecture them or tell them off or bully them if their cholesterol is “high”, why do you agree to get it measured in the first place? There is nothing that I know of that obliges you to have any medical test or treatment that you don’t agree with (unless you are sectioned I suppose, but in those situations your cholesterol would not be of interest, one hopes).

    My cholesterol level is high. Over the last few years it has varied from just over 6 to just over 8. I have refused statins twice, and since doing so my doctor has never given me another cholesterol test. Why should she? If I won’t take the treatment what is the point?

    Thank you so much for a brilliant article, Doctor Kendrick. I always enjoy your work and I recommend your website and your books to anyone who is prepared to listen. I just wish I could persuade my mother (aged 83) to come off statins. *Sigh*

    Reply
    1. Jo

      I think to start with most go along with it before they discover that statins aren’t the wonder drug it’s crack to be. We are led to believe that testing and screening for ‘disease’ leads to better treatment and health. Plus people find it hard to disagree with their doctor. They may go along with the whole thing and just not fill the prescription. I suspect there are quite a few people who do that.

      Reply
      1. Flyinthesky

        The problem with that is once the doctor says your level is too high the fear is set, it takes a lot of self will and self researched knowledge to discard it. Most people would just accept the treatment.
        I tend to think that most health screenings are a combination of aggrandising and empowering the health care profession and monetising the patient. I don’t think it has much effect on actual outcomes it just changes the tick boxes the outcomes are placed in.

    2. Sue Richardson

      I don’t know about others but the reason I had my cholesterol checked was becaus in our local practice we were all sent a letter offering us a ‘Well Woman/Man Checkup’ (I think it was called that) which basically meant you went along to the practice nurse and she checked you out – blood pressure, weight, blood tests etc. I thought ‘why not?’ The end result of mine was that I was recalled and told my cholesterol and blood sugar readings were a little high. I was given an appointment with the doctor, who suggested statins (I said not at the moment thanks, went home and immediately started looking up everything about high cholesterol – eventually finding this Dr Kendrick chap’s blog. Hurray! On the down side, I am also now back and forth to the Diabetes Clinic, because that worried me, and I am currently trying to get my blood sugar levels down with a low carb diet because the last time I went the nurse began murmuring about bringing my level of 7.5 down with medication. To be honest, I rather wish I’d never taken up the offer of a check up in the first place and carried on living relatively healthily in ignorance. Still, I wouldn’t have found this blog otherwise – and I have learnt a great deal more than I knew before!

      Reply
      1. celia

        Good luck Sue. My husband got his blood sugar levels down with the low carb high fat diet I read about on this wonderful blog. No more medications for us…

      2. BobM

        Hi Sue, I wouldn’t be concerned about cholesterol, but high blood sugar might actually be concerning. A low carb diet will help, see:

        http://www.diabetes-book.com/

        However, I think insulin resistance (which you likely have) may be more important. Low carb helps with this, but might not correct things fast enough. I recommend going here and viewing the lectures, particularly the lectures on Type 2 diabetes:

        https://intensivedietarymanagement.com/blog/

        Dr Fung (of the blog listed immediately above) uses intermittent fasting on his Type 2 diabetes patients.

        As always, determine what you think is right and whether either of these is suitable for your particular situation.

        As for me, I started with a low carb diet, which helped. I then realized I was insulin resistant. I now combine low carb (and high fat) and intermittent fasting. For me, intermittent fasting affected my insulin resistance much more quickly than low carb alone.

    3. Anne

      I went to the doctor some years ago with a back problem which was preventing me moving properly. Doctor wanted to test for certain conditions so sent me for blood tests. On returning to his surgery I was informed that my cholesterol was not something I needed to worry about because it was 4.9… I didn’t ask for it to be tested and given I am Scottish, living in Scotland with free prescriptions etc, and under 40 at the time, I certainly didn’t expect he was intending to put me on statins, nor that he was testing for cholesterol anyway. This appears to be done in many cases as a matter of course!

      Reply
    4. Helen

      Just two weeks after I turned 50, the phone calls from a nurse, on behalf of the GPs at my local surgery, started coming…come in for a health check…cholesterol…blood pressure…you’re due for this-that-and-the-other screening programme – here’s an appointment already made for you… On and on it has gone over the past few months. Each time, I have politely declined the offer, but on the surgery’s side the tone has become very testy indeed. I have explained that I’ve been doing some reading and have decided that test/screen X is not for me. This has been followed immediately with a demand that I “must” come in to the surgery to “sign something”. I continue to decline to do so.

      This is a GP practice that will not treat me correctly for hypothyroidism (Hashimoto’s in origin), hypocortisolism (I’m almost down to Addisonian levels), pernicious anaemia, and several other chronic, disabling conditions. I fund nearly all my current care. If I ask for the appropriate treatments on the NHS, i.e. treatments which actually work for me, I find myself subject to threats: perhaps I “would feel happier at another practice”, 20 miles away. This is the reality of NHS GP care: no proper care for established, life-altering conditions; too much ‘help’ offered for non-problems, because they earn the practice a fat fee. Woe betide the patient who gets in the way of this process.

      Reply
      1. Jennifer

        Helen, I blogged the very same problems a couple of years ago, thinking it was just happening to me. Since then, more and more people are telling the same sorry story as yourself…..in my case I went so far as to change my landline and mobile numbers….but didn’t manage to stop the letters coming in the post. ( the familiar envelope used to send shudders down my spine, and stress me out). It has taken until about 3 months ago to get the message across to the receptionists( poor souls, they only have a job to do)…. don’t ring me, I will ring you if I need help.
        Now, this month I would like some help….Unfortunately I am needing to fund my own preferred treatment, because what I have found helpful is not available from my local NHS. So much for ‘free at the point of need’ theory.
        It seems we can have anything we don’t particularly want, but little of what we need. And in this case the GP’s hands are well and truly tied.
        I am able to pay for my needs…but, what about those who can’t afford things?
        “Get what you’re given, and be grateful” so the saying goes, regardless of its effectiveness for the individual.
        Where has the concept of individualised care gone?

      2. Flyinthesky

        In most other areas of expertise this would be described as prohibitive (with menaces) practice.
        The cardinal sin is to understand what’s wrong with you and it’s absolute heresy to want to treat it in your own way. You can’t even purchase at your own expense most of your requirements, they’re prescription only. They do hold all the cards and are not prepared to relinquish any control. It would appear that the consensus would be we’re not smart enough to understand.

        As Malcolm explained some while ago it is illegal to eject a patient from a practice for not submitting to screenings, however being aggressively coerced into submission seems to be acceptable. I think most screenings are paid for on a percentage uptake threshold, the nearer they get to that threshold the more aggressive they become. In fairness it’s the practice manager that instigates hostilities but the doctors are complicit in the main.

        Good luck with joining a practice 20 miles away, with your history I would think they would consider you out of their area citing the logistics of having to visit you. In reality you’d probably need an ambulance before you got one to visit, yes I’ve had that experience with my wife.
        My practice, of some 50 years, ejected me, as a cancer patient, for moving less than a mile out of their preferred area. One can only assume the effort/reward equation wasn’t in balance.

    5. sylvia2036

      The trouble is that for us oldies it always used to be that a doctor’s word was law – old fashioned I know but that’s how it was. Thankfully, more people are beginning to realise that some GPs are absolute fools and so they are ignoring their diktats.

      Reply
  18. David Bailey

    I will certainly not be taking any more drugs to lower my cholesterol – which I no longer have measured!

    This is slightly off topic but in this blog you will find an interesting summary of a paper that studied the self-reported statin side-effects of 351 patients.

    http://vernerwheelock.com/?p=830

    Apart from the usual list of statin side effects, an unusual number of patients were found to have developed serious neurological disorders while taking statins.

    The paper itself is available on the internet as a PDF (reference 1)

    Reply
  19. Sue Richardson

    On the BBC programme ‘Trust Me I’m a Doctor’ last week, ‘leading heart specilist’ Naveed Sattar from Glasgow said “We know absolutely and categorically that lowering cholesterol reduces heart disease risk”. he was talking about statins. A lot of people will have watched that programme and been affected by what such an eminent cardiologist says. Was he preparing the way I wonder.

    Reply
    1. Nigella Pressland

      Agree Sue. I watched him and heard what he had to say with horror. He actually said at one point that statins were safer than asprin.

      Reply
      1. Janet Beach

        Yes, I saw the programme too and was DEEPLY disappointed. No proper explanations just the usual meaningless overall cholesterol level number and all apparently dished up for a group of older women who shouldn’t take the beastly things anyway. I’m surprised that Michael Mosely rolled over and surrendered so readily without a single question asked.

      2. Jennifer

        We could all move to Royal Tunbridge Wells, and write en-mass to the BBC telling them that we are suitably “DISGUSTED” with the lack of impartiality that their medical correspondents are putting across these days.
        (Apols to those outside UK….”Disgusted from Tunbridge Wells” was used on BBC feedback programmes years ago).

      3. Sue Richardson

        Janet and Nigella, yes I was very disappointed too. I thought Michael Mosley would have questioned it more, but he’s obviously sold on statins. Perhaps he’s got shares in something. I have up until now found the programme very interesting, and thought that Michael Mosley was open minded enough have his views changed if the evidence is there to show that cholesterol is not a killer and you don’t need to lower it, by either diet or statins. He has apparently not come across this in his research. What sort of medical journalism is that? ‘Trust me I’m a Doctor?’ Mmmm, not sure now, Michael.😕

  20. maryl@2015

    Another fascinating and alarming post. I cannot believe with all the “statin intolerant” people out there now, who would be so foolish as to try another one? Dr. Kendrick, you outdid yourself in the sarcasm/chuckle division. You really do have to laugh to keep from crying! I am glad some good can come of this crazy but it just is not enough to compensate for more pain and death to come.

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  21. Dr. Göran Sjöberg

    The cholesterol lie has now been repeated for more than 50 years and I guess that this is enough time to make the lie about the benefits of the cholesterol ‘blood letting’ procedure to become true. Though, ‘real’ blood letting was another ‘healing’ practice for thousands of years so probably there is ample time to continue the lie about how fine it is to get rid of ‘high’ cholesterol.

    And we will never know how many that succumbed due to the true blood letting practice – the American president George Washington was evidently one and he was let about 4 litre shortly before his death. For sure we will never know how many who met or will meet an early and unpleasant passing away due to the cholesterol lowering practice.

    It is to me almost unbelievable how peoples mind now have been twisted to demonise a physiologically extremely beneficial substance as the cholesterol. Some years ago a friend of mine brought me to a lecture about cholesterol to be given by a professor from the Sahlgrenska University Hospital in Gothenburg and they actually had to change the meeting room two times when they realised the large number of people approaching and we ended up in the biggest aula of the Gothenburg University being just completely crowded and there to be fed by the conventional nonsense.

    I could not resist disturbing the ‘show’ by bringing my own ‘case story’ up as a refutation, when there were time for questions, although realising that I would be easily dismissed as an anecdote.

    Reply
  22. Tanja

    Have laughed out loud several times. Love your style of writing – truely fitting the topic. The information was very interesting and yes, we’re warned. Having been told to never take any statin or alike again after having suffered diversely and severely, I surely won;t use any stuff even stronger. I’m worried about the patients being dragged into those new drugs, those who’ll get adverse effects.

    Thanks a lot for sharing dr Kendrick! I just from the Neds read your article out loud via skype so my partner in UK was able to take notice of it, too.

    My dad took Inegy, simvastatin plus Q10… what I wonder is… the muscle tissue, as a cardiologist!! told me immediately changes as soon as you take a statin and it never changes back to normal. When you would have muscle pain with merely taking simvastatin you might not feel anything when Q10 is added or feel much less pain/stiffness/weakness etc… I have the idea the Q10 is only camouflaging it. This way, I guess, side effects are less clear to be felt/realized. I’d be interested in how you thnink about it.

    Reply
      1. Kay

        Yes, Judy B., that was only half tongue-in-cheek. I had read something some time ago that “they” were starting to look at the cholesterol levels of pets. When I did a quick check before making my little post above, I came across things like “pets don’t respond to high cholesterol like humans do.” I thought to myself, “Yeh. They respond normally as humans would if left alone.”

  23. Stephen Rhodes

    As I read it http://circ.ahajournals.org/content/116/15/1714.full , the reduction in LDLc is due to a defect in PCSK9 that prevents cells from ‘turning off’ the receptors for LDLc .
    My worry is, “what happens to cells that just keep ‘accepting’ passing LDLc”
    It may well be that the defect is useful in those who do not produce enough LDLc, but damaging in those who do.
    Comments?

    Reply
    1. Dr. Malcolm Kendrick Post author

      I am terribly old fashioned in my thinking. If the body bothers to produce a complex system of limiting LDL production/breakdown, there must be a reason for it. Its the old evolution thing. Get rid of that thing and who knows what will happen. The main problem emerging is the viruses use the LDL receptor system to enter cells. We are probably going to destroy a protection system against viruses (maybe other bugs too). There is growing evidence for this. Watch for a surprising and ‘completely unexpected’ explosion in the rate of heptitis C infections. You read it here first.

      Reply
      1. annielaurie98524

        Somehow, medial researchers don’t seem to understand that complex, resource-intensive processes must have an evolutionary advantage or those with that trait would have died off. Didn’t Big Pharma find they had a Big Problem with biphosphonates killing the osteoclasts to “preserve bone”, right after they spent millions telling all of us middle-aged and older women how we needed to take their “bone-saving” drugs — until some patients found out the hard way why Nature destroys old bone and builds new.

      2. Dr. Göran Sjöberg

        Again, as I like this homeostatic view on the subject of health and sickness.

        This scientific view of bringing in the complexity of our physiology is, in my mind, exactly what the drug companies keep away from at all cost. They like their ‘one-liners’ – fix the ‘problem’ through one specific target attack. To me that is not a scientific attitude.

      3. robert

        George Henderson recently posted a link to this paper on twitter. Free to read.

        “Hepatitis C Virus, Cholesterol and Lipoproteins — Impact for the Viral Life Cycle and Pathogenesis of Liver Disease”

        http://www.mdpi.com/1999-4915/5/5/1292

        I don’t pretend that I understood even a iota of it, but it is obviously way too complex to mess with it by forcefully jamming LDL receptors wide open. An increase of HCV will probably not be the only long-term issue with this.

    2. Pauline

      I was wondering that exact same thing. Do the cells then become stuffed to the gills with lipoprotein and explode?

      The mystifying thing is why the pharmaceutical companies don’t seek to answer this question. They’ve spent gazillions developing the drugs, the last thing they want is for them to be pulled off the market because people are dying.

      Reply
      1. Dr. Malcolm Kendrick Post author

        LDL is mainly pulled back into the liver. Once there it will be unpacked, the cholesterol will be used to make up VLDL and sent back out into the bloodstream. So, then entire cholesterol turnover will probably be increased going round and round ever faster. Quite what this will achieve is up for grabs. There are many such questions.

      2. Flyinthesky

        The only considered question is what are the projected sales figures. The only chance of any realignment of these phenomena is harm on a very large and irrefutable level. The harm thus far with statins and other pharmaceuticals has been carefully concealed.

      3. Kevin O'Connell

        Malcolm’s reply makes me think that there should be (maybe already is) an oozelumab (I see there is actually an oxelumab).

  24. Lynn

    Thanks for this well written post! I have already heard on mainstream US TV about this new class of cholesterol lowering drugs. They are careful not to say anything about all cause mortality being lessened or any possible negative side effects from their use. Isn’t lowering cholesterol enough to get the masses excited and standing in line for this latest whiz-bang therapy? I said to myself, “Well, here we go again.” The masses are asses and I’ll bet even with all the news coming out that saturated fat does not cause heart disease and all the cholesterol skeptics out and about beating our drum there’ll still be many clamoring for this new drug.

    Reply
    1. Stephen

      Lynn, is it fair to blame people for believing their GPs, who are paid to help and advise them on health matters? My brother is a busy, intelligent man who takes statins and blood pressure medication. I wouldn’t take either. I’ve referred my brother to this site and to various Ted talks by Dr Sarah Hallberg and Professor Wendy Pogozelski, but he hasn’t shown the slightest interest. I think his reaction is wrong but entirely rational. Why would his brother know better than his doctor? How could NICE be getting it so wrong?

      I’ve seen how wrong Government can be and I prefer to make enquiries. Most busy people assume doctors know best and follow their advice. We probably all did that until side effects or a more questioning mind made us look into things. Sadly, we’re the minority, although perhaps growing in numbers.

      I find it quite hard to explain how the medical profession can be getting it so wrong. The example I find useful to illustrate how wrong the NHS can be concerns the dietary advice to diabetics. You can’t tolerate carbohydrates? Well, eat 50% carbohydrates and take insulin to reduce your blood sugar. You’ll get steadily worse, but that’s just how it is because diabetes is a progressive disease. Hang on a minute! A century ago the advice was to eat a very low carbohydrate diet and it produced very successful results. Many patients lost most or all of their symptoms.

      We don’t tell people with a nut allergy to eat nuts and take a drug. But we tell carbohydrate intolerant people to eat carbohydrates and take insulin. Most people can understand how dumb that is.

      Reply
      1. Jennifer

        I would love to know the various professions of the 2,500 readers of this blog……seems there must be precious few GPs. I wonder, WHY?

      2. David Bailey

        I find it really hard to advise people about statins. I am not a medical doctor, and I know one woman who is taking statins after a slight heart attack. I point them at this forum and Dr Kendrick’s book, but it is extremely hard to know what else to do.

        Would your brother read “The Great Cholesterol Con” if you bought it for him?

        Maybe you should insists that at least he listens to the main side effects – then if he gets any of them, he may realise you were talking sense. Muscle/joint pains, memory problems and raised blood sugar. Perhaps he is one of the lucky ones who can take this poison and not be damaged.

      3. Carol

        But what do you when your blood pressure is high. Tried all the supplements l-arginine, cq10, magnesium etc. went to see Dr Kendall a years last March about blood pressure and cholesterol. His nurse advised low carbs and loose weight. I’ve done that and lost over a stone and cut down on alcohol. Blood pressure is still high when I try to stop meds. Meds seem to be the only thing to keep it down. I know they are bad for me.

      4. Dr. Malcolm Kendrick Post author

        As a general comment, and not replying specifically to your question in any way. With resistant raised BP you should always check for subclinical Conn’s syndrome. Then some might say, try an aldosterone antagonist. This comment cannot be taken as medical advice.

      5. Kay

        Carol, regarding the blood pressure thing: Would it be useful to have a home monitoring device? Sometimes what shows up at the doctor’s office is not at all the blood pressures one has at home from day to day.

      6. OldTraveller

        I know quite a few academics and they tend to think that if someone has the same level of qualification as them, e.g. professor, then they must be experts, so they follow them unquestioningly. In fact, it’s sometimes the ones we consider not that bright that question things. That’s not always the case of course, but it explains why some otherwise smart people follow doctors with something near to blind obedience.

      7. Carol

        Kay, I do test it at home. Everything is ok if I take the meds. If I come off the meds then it goes high at home as well. Trying to come off the meds.

      8. Flyinthesky

        Stephen, ” is it fair to blame people for believing their GPs, who are paid to help and advise them on health matters?”
        Not at all, that’s the illusion. They are in actuality well remunerated over empowered agents of the state. They get to espouse the ultimate emotive, be mindful of our opinion or die.
        There is no greater empowerment than that.

      9. David

        “How could NICE be getting it so wrong?”

        I don’t think they are getting it wrong. It is not their job to evaluate drug safety but to determine value for money given what is “known”.

        Statins are so cheap they would hardly have to demonstrate a miracle cure in order to be considered value for money. The “side effects” are, unfortunately, hearsay. There are stories of reactions from patients, there are suspicions about some (or most) of the trials being ended early, about participants being screened before taking part and results being kept confidential but they are cheap and appear to show some benefits (almost).

        So there might be some small pros but few cons accepted by the medical industry.

  25. Eric Thurston

    Dr. Kendrick,
    Another much needed analysis and warning of what is to come from Big Pharma. They are looking for the next huge profit making drug.

    I think the typo in this sentence “However, once patient protection is gone, …” was somewhat of a ‘Freudian slip”. It seems that ‘patient protection’ is gone once we start taking their pernicious concoctions.

    Reply
  26. Kay

    It remains to be seen, I suppose, whether cheaper generic statins will mean that doctors prescribe them even more freely. Unfortunately, there are hordes of people who have problems with statins who will now be “statin intolerant” and fair game for the new drug. One can only hope that some will be spared because they find the injection thing too inconvenient.

    Reply
    1. David Bailey

      My experience of just chatting with people I know, is that of those given statins at least half – maybe more – suffered side effects, and nobody described them as trivial.

      Most just stopped taking them, so they were probably never recorded in the statistics!

      Mine took 3 years to come on, so even some of those who said they were happy with their statins were possibly due for an unpleasant surprise! I had been taking them so long, I was lucky to make the association between my symptoms and the statins.

      Reply
  27. annielaurie98524

    Oh,
    Dr. Kendrick, your post was far funnier than the joke of the day! I laughed so hard, my diaphragm hurts, even though I was sad to learn that more gullible folks are going to be fleeced into taking drugs of dubious effectiveness with (at this point, unknown) side effects, while the hired guns and Big Pharma execs bank their ill-gotten gains. You have a talent for letting folks know what scam artists the Big Pharma companies are, how they literally get away with murder, how they finance their hired guns, and how they generate fear in the public, but you do it with such good humor that people can learn far more from your post than from some dry news article.

    Reply
  28. Jean Humphreys

    Damn. I wondered if it was wise when I made them put “intolerant: statins” on all my notes.

    Reply
  29. Anne

    Are these drugs more or less likely to be offered first to patients who have had a very recent “scare” and therefore they simply won’t refuse because this is so fresh in their minds and worrying enough that they will take all doctors advice because “they know best” and these patients simply don’t want to die?

    Reply
  30. Catherine Reynolds

    My husband was diagnosed with male breast cancer in April, and has had surgery to remove the tumour and some lymph glands. It was very successful, and he declined chemo, choosing to take Tamoxifen and have a course of radiotherapy. In the meantime, our GP has prescribed him Atorvastatin. I recall reading somewhere that statins can allegedly have the effect of reducing the chances of breast cancer returning – is this the case, or is it another pup we’ve been sold because we’re all so terrified of cancer? Four years ago, following a minor heart attack, he was prescribed Simvastatin (despite showing a cholesterol level of below 4), and suffered horrendous side effects. It took me showing him your blog, Dr K, before he would consider stopping the Simvastatin. He is now very wary of the Atorvastatin, but, again because of the cancer diagnosis, he feels he should take it. I’m not sure he’s actually been told why he should take it, or even whether he has asked why he should take it. When I asked him why he was taking it, he shrugged his shoulders! Any comments/observations on this gratefully received!

    Reply
    1. David Bailey

      My feeling is that there comes a point when you just have to say “No!”. I mean, we none of us live forever, and if your husband messes up his time with statin side effects – which don’t always reverse if you stop the statin – he is going to be pretty miserable.

      I will always refuse statins or other cholesterol lowering medicine regardless of what I am told – once bitten, twice shy!

      Unfortunately the medical profession is clearly in a mess, and just doing what the doctor recommends isn’t really an option any more.

      Reply
      1. celia

        David, I think your comment that statin side effects don’t always reverse is very important. While my memory and tendon side effects went, my loss of muscle seems permanent and is causing other problems. My body now feels 15 years older than previously. Anyone thinking of taking statins – please note.

      2. Catherine Reynolds

        Indeed, David – he has a follow up appointment soon, and I’ve asked him to put this specific question to the doctor. I just can’t see why you would want to potentially lower someone’s cholesterol level when they are recovering from any operation, let alone from one to remove a cancerous tumour. I also feel that there is always the “polypharmacy” question, too. Tamoxifen is obviously a serious medication, also with potential side effects, and to mix this with a statin seems a little worrying to me.

    2. celia

      Catherine, your husband might do just as well, if not better, taking vitamin D. (See Dr Mercola 28th July). Contrary to some pharma suggestions, I have also read that statins might actually cause cancer. I do sympathize. It’s very hard to know what choices to make in a situation like his.

      Reply
      1. Catherine Reynolds

        Thanks for that, Celia! Vitamin D would be fairly simple to get in to him, too. He’s an “outside” type in any case, so let’s hope for some good sunshine to boost it!

  31. Leigh

    Proprotein Convertase Subtilisin Kexin Type 9. Catchy little title that. Understandable it should be initialised PCSK9. Personally, I prefer Pharma Companies Serial Killer No 9 (presumably the previous 8 efforts weren’t as profitable or as harmful as statins)….. Come to think of it, wasn’t there a song ‘Love Potion Number 9’? Now that really WOULD make serious money for Big Pharma.

    Reply
  32. plumeriopipichas

    There have been several drugs (aside from statins) that do lower cholesterol, but have failed miserably when tested in random trials for cardiovascular conditions. Isn’t that the case? If so, whatever hype surrounding the PCSK9 inhibitors seems ridiculous, at least before the trials go through… but anyway we’re all been warned, haven’t we?

    Reply
  33. Chris Harvey

    Hello
    About side effects, does anyone have an idea how long after stopping statins, the muscle pains take to disappear?

    Reply
    1. lindsey

      The damage caused a cholesterol lowering drug, can be reversed, sometimes, by a natural curative substance called… cholesterol!
      Isn’t that neat?
      Cells will restore themselves to health, if they are given enough nutrients by the blood. How do nutrients reach the blood? Most nutrients are eaten, and have to be properly digested. Good food plus bad digestion equals malnutrition.
      How to have a good digestion? Interestingly enough, there are foods which help with digestion, and foods that wreak havoc in the stomach and in the gut. Good cooking helps digestion, too. Some vegetables need longer cooking times than what we usually think. The more you eat the right foods, correctly cooked, the better the digestion. It’s like playing a musical instrument.
      In particular, water and salt seem to be helpful with digestion.

      Reply
  34. Sue Richardson

    BobM. Thanks for those two links. I already follow Dr Bernstein and have his book, which contains everything you need to know about diabetes and more! I found Dr Junk’s site very very interesting. I followed the 5/2 day diet for a while (after watching ‘Trust Me I’m a Doctor’ ironically) but at the time I wasn’t aware of my possible insulin resistance – it just sounded healthy, and I have no idea what effect it had on my sugar levels at the time. I have searched Dr Jung’s IDM site but can’t find how to actually start intermittent fasting. Maybe it’s just common sense. I can’t ‘join’ because I live in the UK, so whatever advice I glean will have to be over the Internet. Many thanks for the link. I’ll certainly give it a go.

    Reply
    1. Pauline Card

      There are some interesting interviews with Dr Jung on the dietdoctor.com website (an LCHF information site). They are in the membership section but there is a one-month free membership offer. They may answer many of your questions in a briefer, more accessible format than the IDM website.

      Reply
      1. Sue Richardson

        Thanks for this Pauline. One of the things love about this blog is that people are so helpful and pass on what they know so that others can benefit.

  35. Odette Hélie

    Hello,
    What about the model proposed by professor Unger : impairement of insulin secretion leaves all the place to glucacon which translates by high blood sugar and high neoglycogenesis ?
    Does it fit just before the “insulin resistance” stage in your model or do you consider it as another model ?

    Reply
  36. Mich

    The problem with FH is that it is an exceedingly small market, about 5000 worldwide. These inhibitors might be beneficial to them (and them alone) as they are effectively “cholesterol resistant”. Allowing their cells to use the item they need most would make them function as they were designed to.

    My parents are both on statins, but they believe their doctor is god, and he won’t say a bad thing about statins, and willy nilly prescribes unethical treatments to anyone. On the site ratemds he has 2 entries (due to a hyphenated last name) and most of the negative ones are quite specific in his incompetence. I’ve reported on there, and to the provincial health system, but to no avail. I reported him abusing my mother, asking if there are any resources of how to cope with a family member taking statins like they have programs of how to live with a family member with Alzheimer’s, but the jist of their response was “we know it’s hard, but suck it up”.

    I have considered going to a lawyer, but we are very poor and I’m sure we wouldn’t be able to afford it. Also the medical lawyer I was examining (when I contacted him) is actually a defense attorney for the docs, and he has a 100% rate, so if he’s protecting their doc, we’re sure to lose. My next step would be to go to the media and expose the rampant unethicalness of his office, and the liver specialists who have also failed to catch it.

    Reply
  37. Colin Weeks

    Hi Dr Kendrick

    I am always interested in your detailed posts. I expect that you have answered similar questions many times but here goes

    1) Can the effects of statins occur after using the drugs for many years? Friends are having serious leg and foot pains.

    2) I have several friends that have had stents implanted. All of them are immediately put on statins. Is this necessary??

    Both groups continue to be given statin prescriptions.

    Colin Weeks

    Reply
    1. David Bailey

      Colin,

      I got a nasty reaction (not dissimilar to your friends) to Simvastatin after 3 years of use – so the answer to your first question is definitely yes!

      I know it was a reaction to the drug, because I stopped the statin ‘just as a precaution’, and the symptoms started to get less … so I started again, and they got worse – in all I repeated that cycle 3 times, not quite believing that the statin was doing what it did! In my case the improvement was noticeable after about a week.

      After I stopped for good the symptoms took about 9 months to vanish completely (but unfortunately not everyone does recover completely).

      Reply
  38. Lysander

    This racket would be much more difficult to pull if Governments were not nurturing it.
    Patents must die.
    People see Governments as the “protectors”. They suffer intense pain when they realise that the “protectors” are in cahoots with the wolfs. It is a very subtle form of Fascism, laced with lots of psychological manipulation. By the way, the supposed “opposite” of Fascism is not a better option.

    Reply
  39. Nate

    Well, I’d like to share a more pleasant thought about these new PESKY drugs or whatever they are called. The Dietary Guidelines Advisory Committee (DGAC) 2015 report advises the USDA that cholesterol should be considered a substance of NO CONCERN and that no limits should be put on saturated fats. Now, the USDA has not yet said that they agree with their experts and so it is not official USDA policy yet.

    OMG, those PESKY pharmaceutical companies must be hiring lobbyists like crazy in Washington these days. They will inform the USDA that money is more important than whatever those quacks, er experts, say. (Can I call the DGAC experts now even though they were implicit in getting statins rolling down our throats?) The lobbyists will really want to slow that decision making process down, let alone, try to reverse the experts opinion. Makes me smile…Oh, wish I was invested in a Washington DC restaurant.

    Reply
    1. Jean Humphreys

      It’s not as great as it seems – they refer to cholesterol as not a nutrient of concern – i.e. eat as much of it as you like, but you can bet your sweet life they are going to be waiting with the proverbial ton of bricks if we dare to produce more than they deem correct in our own metabolisms.

      Reply
      1. Nate

        Sad, isn’t it? But I’d rather spend a moment or two concentrating on the 10% full glass rather than always on the 90% empty part. I think and feel that is good for my heart.

  40. Sarah C

    Just out of interest (and leaving aside the the question of whether statins should ever be prescribed) how much money would the NHS have saved if the threshold for these prescriptions was raised by (say) a whole point – ie from 5.0 to 6.0? And how much would be saved if BP meds were prescribed at 150/95 instead of 140/90? And how many more deaths would be ascribed to raising those thresholds?

    I suspect that the answer would be sufficient to fund at least some extra staff and procedures such as hip replacements, and maybe even some of the more expensive cancer therapies.

    If the elderly weren’t victims to polypharmacy, would the saving be sufficient to offer them proper personal care and a little more time (all some of them really need)?

    The pharmaceutical companies aren’t just making huge (obscene) profits, and driving those profits higher by bringing down these thresholds – they are actually depriving thousands of people of their quality of life!

    There’s my rant for the day!!

    Reply
  41. Steve Morrissey

    Dr Kendrick,
    I don’t know if you have seen this article on the Reuters web site, it seems to be looking at some of the points you have raised from the viewpoint of the health insurers and I thought you might find it interesting.

    http://www.reuters.com/article/2015/08/10/us-health-cholesterol-cvs-idUSKCN0QF1RY20150810

    To quote from it:-

    ‘CVS and other pharmacy benefit managers are concerned about the cost of the PCSK9s compared with older cholesterol fighters such as statins, which are available as generics for less than $50 a month. Praluent, given by injection, has a list price of almost $15,000 a year.
    Both Praluent and Repatha, in combination with statins, have been shown to lower cholesterol by around 60 percent compared with statins alone.
    “The current cholesterol management guidelines do not provide clarity as to how these expensive new medications could fit in the treatment paradigm, potentially resulting in some scenarios where a prescriber could consider a PCSK9 inhibitor for a low-risk patient,” Dr. William Shrank, chief scientific officer at CVS, said in a statement.’

    The article then goes on to discuss LDL cholesterol guidelines (or lack of them). And there is an interesting quote from the president of the American College of Cardiology (ACC).

    ‘Some prominent cardiologists have questioned the 2013 guidelines, but the ACC and AHA have shown little appetite to return to LDL targets. “LDL may or may not correlate to cardiovascular outcomes,” Dr. Kim Allan Williams, president of the ACC, told Reuters last week.
    Williams said on Monday, “The potential of this new class of drugs is exciting, and we look forward to data from the clinical trials in progress that could demonstrate whether these new cholesterol-lowering drugs will benefit a wider group of patients. In the meantime, … any changes to them (guidelines) must be supported by evidence.”

    The AHA said in response to a request for comments, “We continually weigh our recommendations against current science and update our guidance accordingly.”’

    So LDL may or may not correlate to cardiovascular outcomes according to the president of the ACC.
    Whether the results from trials on people with familial hypercholesterolemia (FH) can then be applied to other people is a question. PCSK9 inhibitors can cause serious side effects [1] and using LDL as a surrogate target might not be valid since ‘LDL may or may not correlate to cardiovascular outcomes’.

    Reference

    (1) Press Release
    http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-fda-approval-of-praluent-alirocumab-injection-the-first-pcsk9-inhibitor-in-the-us-for-the-treatment-of-high-ldl-cholesterol-in-adult-patients-300118572.html

    Reply
  42. Marie

    Even more incredibly….

    http://www.marketwatch.com/story/positive-clinical-data-from-lpa-lowering-drug-isis-apoa-rx-published-in-the-lancet-2015-07-22

    “The Lancet has published clinical data evaluating ISIS-APO(a)Rx in healthy volunteers with elevated lipoprotein(a) or Lp(a). An accompanying editorial was also published. ISIS-APO(a)Rx is a Generation 2.0+ antisense drug that is part of Isis’ lipid franchise, which is being developed and commercialized by Akcea Therapeutics, Isis’ wholly owned subsidiary. ”

    An “antisense” drug called ISIS? Did they name it before recent events in Syria and Iraq? It seems a bit of a marketing minus, but what do I know?

    Reply

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