Changing the definition of Familial Hypercholesterolaemia

I am grateful to Mike Sheldrick, a reader of this blog for spotting some news, that was not entirely expected by me. For reasons that I will explain later. As you may know two new cholesterol lowering drugs have now launched. Two PCSK9 inhibitors. I call them the ‘dreaded’ PSCK9 inhibitors. I have written about them a few times. There has been surprisingly little noise about them so far, at least in the UK. Not sure about the US or the rest of the world. They are called Repatha and Praluent. Catchy eh!

These drugs have two major problems at present, at least from a money making perspective. They have no outcome data, by which I mean that they have not been shown to reduce the risk of heart attacks, strokes… or anything else for that matter. (They have been launched purely on their ability to lower LDL to violently low levels). They are also extraordinarily expensive. In the UK Praluent will cost between four thousand to eight thousand pounds ($6 – $12K) per year, depending on the dose1.

Which means that the NHS can, if it so wishes, pay eight thousand pounds a year for a drug that does not actually do anything – other than lower a surrogate marker for heart disease. Now, this may not be seen as bargain of the year. I can imagine great battles are going on right now between the pharmaceutical companies and NICE. The organisation that decides if a drug is cost effective, or not.

At present I would think that the response of NICE would be ‘Are you out of your tiny little minds. Why the [[…] insert swear work of choice here], would we fund this?’ At least I would certainly hope this would be their response. Imagine if everyone on statins in the UK, around seven million, changed to PCSK9 inhibitors This would cost £56 billion pounds [$80Bn] a year. A tidy little sum. Half of the entire NHS budget.

So, what to do? You have this amazing cholesterol lowering super-drug that does nothing, and it is enormously, eye-wateringly expensive. Come on, come on. Think!

To be frank, I thought that the primary marketing tactic would be to claim that statins actually have many, many horrible side-effects – that no-one noticed until…. there were new drugs to be launched of course. Which would mean that all those people who were ‘statin intolerant’ would need to take PCSK9 inhibitors instead. To get that horrible, damaging LDL level down. There is no doubt that the attack on statins is currently happening, but there has been more resistance to this than expected.

So, what else can you do? Well, there is one population where cholesterol lowering is seen as absolutely essential. The population is those who have familial hypercholesterolemia (FH). This group has always been considered at such a high risk of dying from heart attacks and strokes, that no clinical trials have even been done. You just do anything, and everything, to get the cholesterol (LDL) levels down, no questions asked. [No evidence of benefit needed either]

At present about one in five hundred people have FH and, when I started thinking about, I realised that this is really a big enough market for PCSK9 inhibitors. Just to do some simple sums. There are sixty-five million people in the UK at present. If one in five hundred has FH, that represents an FH population of 130,000. If every single one of these people goes on the higher dose of one of these drugs, the total sales would be £1Bn/year. In the UK alone. That is a blockbuster in anyone’s eyes.

If we transpose these figures to the US. The total population in the US is three hundred and twenty million. Which means that 640,000 people will have FH. With Praluent selling at $14,000/year, that would be $9Bn/year in sales in the US alone. Worldwide we are talking tens of billions a year. Of course, there are two virtually identical drugs out there, Praluent and Repatha, so divide the market by at least two – and there are more PCSK9 inhibitors in the pipeline.

Reducing this market still further, not everyone will take an injectable medication every two weeks, no way. And so the total market, though still massive, shrinks down ever further. Realistically, you might get a maximum of a quarter of those with FH on your drug. Amgen, for example would have to cope with piddling sales of $10Bn/year worldwide. Which will not do, not at all. More money must be made.

Of course, the simplest thing to do, to get round the problems with market size is simple. Make the market bigger. And the easiest way to do this is to widen the criteria for Familial Hypercholesterolaemia (FH). And lo, it has come about. The American Heart Association has stated that the level of LDL at with FH can be diagnosed is to be lowered:

“More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron)….

The new criteria for heterozygous FH sets an LDL level of at least 190 mg/d L (4.9mmol/l) for adults who have a similarly affected first-degree relative, premature coronary artery disease, or a positive genetic test. According to Mann, 3% of the population has LDL levels over 190 mg/dL level, but, she points out, “less than 1% of the population has FH. You could have docs diagnosing people with HeFH or HoFH* solely so that their insurance will cover a medication, such as PCSK9 inhibitors. That could be very confusing for patients.”2

*HeFH = Heterozygous Familial Hypercholesterolaemia (affects 1:500 – high LDL levels)

*HoFH = Homozygous Familial Hypercholesterolaemia (affects 1:1,000,000 – super-high LDL levels)

In one simple stroke, the market for PCSK9 inhibitors in the US has been increased from 640,000 to 1,920,000. Or, in monetary terms, $9Bn to $27Bn. There, that’s more like it. In the UK the market goes up to 400,000, with max PCSK9 sales going from one billion to three billion pounds sterling. A clever little trick.

I must say that I, possibly the most cynical human on the entire planet, never thought they would do this. I discounted as just too brazen. It would just be likely to be laughed out of court. Silly me. No-one is laughing. Experts are rubbing their chins and nodding sagely at the wisdom of this move. New swimming pools all round, is what they are probably thinking.

Do you think that the American Heart Association’s (AHA) decision here may have been affected by commercial sponsorship? This, of course, would be impossible to say – without getting sued senseless for libel.

However, I had a little look around the AHA, and Amgen, also the ‘non-profit’ FH Foundation and Amgen, and suchlike. Here is one statement from the AHA site. ‘Amgen is a proud sponsor of the American Heart Association’s Heart360 Toolkit3. Ho hum Needless to say. Amgen are also ‘proud’ sponsors of various AHA meetings.

In addition, Amgen are also a foundation ‘corporate sponsor’ of the FH foundation4. They are probably very proud of that too. Finding these financial relationships can be a little tricky, as they are usually hidden in the depths of various websites. Perhaps other mike care to improve on this list…. Probably not that hard to do.

Money makes the world go around, the world go around, the world go around.’

1: http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5687

2: http://cardiobrief.org/2015/11/05/new-definition-of-familial-hypercholesterolemia-could-expand-patient-population-for-expensive-cholesterol-drugs/

3: golowcholesterol.com/tag/amgen/

4: https://thefhfoundation.org/about-us/sponsors/

215 thoughts on “Changing the definition of Familial Hypercholesterolaemia

  1. mikecawdery

    Dr Kendrick,
    Another winner and an exposure of the tricks that Big Pharma get up to to make a buck; sorry a billion bucks. And on the basis of NO EVIDENCE OF CLINICAL BENEFIT. I bet that you know who is designing a clinical trial that will produce the necessary “evidence” for a claim of evidence-based benefit.

    Thank you. I had thought that the shear price alone would lead to a ban.

    Do you think that the American Heart Association’s (AHA) decision here may have been affected by commercial sponsorship? This, of course, would be impossible to say – without getting sued senseless for libel

    Can an Association sue for libel? I thought not. Anyway as a US cardiologist told me, the AHA has well and truly sold out to Big Pharma $millions.
    Can an Association sue for libel? I believe not. Anyway as

    Reply
    1. mike_cawdery

      Interesting? one objector. Was it the “NO CLINICAL EVIDENCE” by a cholesterol supporter or the comment about the AHA having sld out to Big Pharma?

      Reply
  2. Dr. Göran Sjöberg

    Your post reminds me of a scene in a book I read many years ago, “The Tin Drum”, by the famous author and nobel prize winner Günter Grass. As far as I now remember (I might though misremember the details) that surrealistic scene it was about a number of people who regularly met for crying sessions at which they were chopping onions to help make the tears flow.

    Reading you post we don’t need any onions at such gatherings to be successful.

    Reply
  3. Tom Welsh

    “I must say that I, possibly the most cynical human on the entire planet, never thought they would do this. I discounted as just too brazen”.

    I’m afraid you forgot the basic principle of the Big Lie, Dr Kendrick. Namely, the bigger the better.

    “The great masses of the people in the very bottom of their hearts tend to be corrupted rather than consciously and purposely evil … therefore, in view of the primitive simplicity of their minds, they more easily fall a victim to a big lie than to a little one, since they themselves lie in little things, but would be ashamed of lies that were too big”.

    – Adolf Hitler, Mein Kampf (Houghton Mifflin Co., Boston, 1971; original version 1925), Vol. 1, chapter 10, p.231

    Reply
  4. celia

    What can I say? Yes, money does make the world go around, even to the extent of charities allowing the fox into the henhouse in exchange for sponsorship. We really do have to follow health matters carefully for our own protection.

    Reply
  5. Gay Corran

    Another corker, Dr Kendrick! Expanding the number of people with FH is very much on a par with lowering the cholesteral numbers to those which mean everyone on the planet “needs” to take statins. So Mother Nature built us to evolve into beings who will not survive unless we take mass medication from an early age? Isn’t evolution wonderful?

    Reply
  6. David Procter

    It’s not just money, though that is undoubtedly a huge part, but the fact that doctors on the whole by temperament, training and inclination want to medicate people. Few doctors in the modern world of medicine want to encourage their patients to take a more robust approach to their lives and their health so any opportunity to put someone on some kind of medication is grabbed with both hands.

    Reply
    1. Elliot

      I don’t believe doctors are really trained in a “healthy lifestyle” more than likely on purpose. They lack information on nutrition, exercise, stress relief, etc, plus they don’t put much time in studying the side effects of medications. It’s not that they won’t give their opinion on these subjects but don’t actually study much of this. After spending years and years of going to school and residency why would they start questioning medications. I think their main concern after school is getting out of debt and starting a practice.

      Reply
      1. David Procter

        I agree. A friend of mine once told me bluntly, “The doctor isn’t interested in you, to them you’re just a piece of meat that they have to keep within a certain range.” However, we all, including doctors, have to live in the real world and doctors are in a position of great power and responsibility which many of them abuse in the privacy of their surgeries each day by taking what is often the easiest way out which is most likely chemical medication based upon statistics rather than taking into account the views and feelings of the unique individual in front of them who is the world expert on him or herself.

      2. Jennifer

        In response to David Proctor I would say that your friend paints a rather dismal picture of doctors, but from what I am reading on this blog lately, it would seem to be a pretty accurate assessment.
        What a damned shame that such a wonderful profession is deteriorating in the eyes of the public so that we can no longer trust their judgement.
        Surely this cannot be so. Perhaps the concentration of bloggers on this site, obviously made up of individuals concerned about the cholesterol myth, is distorting my perception….I sincerely hope so.
        I also must point out that we ought to take account of the way medicine is practiced in different countries, namely the concept of private versus public management of health. Let us see which model cracks first in providing or dismissing these ultra expensive drugs as Dr Kendrick mentions, and what reasons they give for their stance, be it for or against their use.
        We are living and dying (perhaps prematurely) in interesting times.

      3. BobM

        I’m not sure it’s totally the doctor’s fault. I just had a conversation with someone who said their health insurance company had policies where “healthier” people paid less and “less healthy” people paid more, unless the latter followed the “rules”. There’s a similar aspect where the health insurance companies put pressure on the doctors to make people “healthy”. Thus, both the patients and the doctors could get pressure to use drugs, such as if cholesterol or blood pressure is “high”. The doctor (or the patient) might not want to do this, but it’s difficult to fight bureaucracy.

      4. Barry

        Elliot,
        Nutritional ignorance is not by accident. It may be linked back to the Flexner Report, funded by the Carnegie and Rockefeller foundations. They wanted nutritional science removed from the medical school curriculum and they succeeded. The result is that most doctors have been, and remain, nutritionally ignorant. The concept of preventing or treating health issues by diet is not in the interests of the drug cartels (the foundations of which may be found in the chemical industries supported by the Carnegie and Rockefeller foundations) or the processed food industry.
        Eat the rubbish produced by the food industry and your health deteriorates, you go to the doctor who most likely will prescribe a drug to “cure” the illness. The vested interests profit at your expense (wealth and health) whereas if you were to see a doctor knowledgeable in nutrition they, depending upon the degree of damage to your body, be able to counsel you as to where you have gone wrong and what you should consume to promote health.

    2. gillpurple

      Yes, David. The sooner doctors are expected to make use of all those years of training, think for themselves, problem solve with their patients in a co-operative way, stop following some of the mad guidelines and get paid to put the patient in front of them first the better. Ban those blinking computers. Will this happen anytime soon? I doubt it.

      Reply
      1. Dr Liz Stansbridge

        I was a doctor. I was a psychiatrist, deeply concerned.
        I was interested in my patients. I thought I could save the world. I thought I had all the info. necessary to make a difference.
        I was wrong. We are all duped by the pharmaceutical industry.
        It’s all about money.
        It’s all about money.
        Psychiatric training, trying to become more credible has gone all ‘scientific’!, pushing statistical analysis . How on earth has human behaviour managed to become a statistic?
        To pass college exams you need a ‘deep’ understanding of statistics to interpret papers. Hasn’t helped anyone I know to interpret ‘science’
        I rather think a superficial understanding of elementary concepts as ‘relative risk’ would have served us better.
        Us freethinkers can’t operate in the NHS. It won’t let us.
        Nurse assistants operating to ‘Guidelines’ are the way forward in the NHS. Much cheaper than doctors.
        All I can say is:
        Don’t get sick.

  7. Gary

    Great! Malcolm, you’re always a great read. The oligarchs are firmly in charge here in the good ole’ U S of A, and I’m pretty sure that’s true in the UK as well. David Proctor is also correct that physicians are trained to spot disease and shove drugs in, though my own is one who listens to the patient. At 66 I take only an ACE inhibitor, but will be weaning off of it, at least until I can see the raw data from all the relevant clinical trials (though I’ll be six feet under by then).

    Reply
    1. Trish

      Hi Gary, interesting about Ace inhibitors, Firsly, just my story not suggesting you should do the same.
      I was prescribed Ramapril 2.5 years ago. My BP on the day I called in the docs to use the DIY BP machine was 200/120mmHG.
      Was told to go home immediately as big probability could drop dead & come back for urgent appointment the next day, that started the low dose Ramipril increasing to eventually 5mg.

      I don’t like taking meds unless essential (life saving, then gladly!), so was disappointed to say the least. I decided in Sept ’15 to stop taking them & made big lifestyle changes. More exercise, high fat, low carb diet & no grains. Oh & a daily glass of red wine.
      Whilst on Ramipril my BP hovered around 140/95mmHG, still apparently not ideal! So monitored BP carefully when I stopped taking it, as I’d prefer not to drop dead, with the premise that I’d go back on them if needed.
      Well guess what!! Without meds my BP is now 117/80mmHG ish on a regular basis.

      What did surprise me was that I hadn’t realised that I had side effects from taking them. My husband & I have always walked regularly, he said ” Have you noticed we don’t stop anymore so you can catch your breath going uphill.” Had insomnia over same period which is getting better & I have much more energy & more positive outlook. I don’t know what the half-life of Ramipril is, but things can only get better?

      Interestingly, noting Doc Kendrick’s book on cholesterol, & his ideas on stress, I wondered about its effect on BP? At the time I was diagnosed with “high” BP, I’d just come out of a school meeting where my son was about to be expelled, he’d left to go and live with his dad’s girlfriend. That changed finances & savings expired. Worked with a colleague in a new job who to say was a “bully” was an understatement. Plus my ex husband was being aggressive & difficult with the divorce settlement.
      Now I haven’t shared those details for a “woe is me, tack” but none of these things apply now, & guess what BP normal.

      Good luck with your future choice….

      Trish

      Reply
      1. Carol

        Hi how long did it take for your blood pressure take to return to normal. Was it a all over the place to start with when you stopped. I’ve stopped 2 weeks ago but today blood pressure went up to 170 over 90

      2. Kamaldeep Sidhu

        Hi Trish,
        I’m a Medical Herbalist here in the UK and was interested by your post. I’m interested in the gut microbiome and often use it as a basis for improving the health of my patients. Recent research is suggesting that hypertension may in fact be linked to gut health, specifically, gut dysbiosis. So, when you cut out grains and decided to eat a more high fat/low carb diet, you essentially changed your gut microbiota away from acetate- and butyrate-producing bacteria and thus had a direct, physiological impact on your blood pressure. I have seen consistent results in my practice to the same effect. Increasing the biodiversity of our gut microbiome has a huge beneficial impact on our health. Keep up the good work!
        Kam

      3. Carol

        Hi Kam, I am very interested in what you are saying to Trish. Do you have any more information on what you are saying. Are you also saying that potassium bicarbonate 2g will help the gut and lower blood pressure.

      4. carol

        Thanks was on two meds but stopped losartan a month ago. just taking vascalpha at the moment so I think that should be ok shouldnt it?

      5. Jennifer

        I am trusting that a sliced banana in greek yogurt, drizzled with dark chocolate will provide enough potassium for me.

      6. Kamaldeep Sidhu

        Hi Carol,
        Sorry for the delay! I think changing your diet will be more effective than introducing potassium bicarbonate. Dietary modifications when done well are the most effective strategies. Not sure if I can leave my website with more info…it might be classed as advertising! Trish seems to have made the right dietary changes already…a good protocol to start with is no grains/dairy/sugar/potatoes/legumes (See Dr Loren Cordain and Staffan Lindeberg for evidence based info on this). Hope this helps.

      1. Trish

        Hi Carol, it is possible the weaning process is different for everyone. However, I’m not sure about the reliability of reading & ranges of BP either. As Dr K says, a ‘normal’ BP range was higher years ago than now, which like this new FH issue, moving the goalposts makes more people in the target group. That said, I do have ‘White coat’ BP. So I started recording my BP & looked for patterns.
        1. If I took readings of both my R & L arms, my R arm was consistently higher. So which is the true reading?
        2. If I sat at a table & rested my arm on the table as per machine instructions it was a lower reading than when on my lap as often GP’s will take it.
        3. Readings were lower when I made sure the cuff was level with my heart, as per machine instructions.
        4. Taking a reading then another one two minutes later always resulted in a lower reading at any time of day.

        My readings fluctuated for the first month, but not stupid high, then I started potassium bicarbonate 2g per day which seems to help reduce my BP with no side effects & all ok at the moment.

        Plus a big thing, stopped getting hung up on what my BP was, pre the initial docs visit, I never thought about it.
        Just feel I’ve got control back. When you’ve got the true info you can make better choices.
        Trish

      2. carol

        Thanks Trish. Do you get potassium bicarbonate tablets or the powder form. Can I ask where you purchase this form. Thanks.

    2. Sarah

      Hi thinking of seeing a Nutritionist/functional medicine practitioner for high blood pressure. What do people think. any good. Ann Pemberton in Leeds has been recommend. Don’t want to waste my money. thanks.

      Reply
      1. Kamaldeep Sidhu

        Hi Sarah,
        Don’t waste your money. Start with cutting out grains/potatoes/dairy/legumes and sugar and go from there. See Dr Loren Cordain’s and Staffan Lindeberg’s websites/lectures for the evidence-based why’s and wherefore’s. It’s a start!

  8. Jennifer

    Mind-boggling statistics which are so incredible, that I suspect no one in authority will even venture to question them. It will be interesting to see what NICE make of these new toxins.
    But, count me out thanks, I wouldn’t want to be greedy for NHS resources, you understand, ha, ha.
    But this is far from a laughing matter.

    Reply
  9. Don MacG

    One would think that the USA insurance companies – data driven to the extreme – would catch on to this corruption and oppose it. After all, it is not in their interests for unnecessary treatments to be given, expensive drugs to be used for no good reason, or indeed for people to die before their time. Yet they seem to have no voice.

    Perhaps they don’t care, and are able to use realistic figures to calculate actual risk, while charging premiums based upon bogus data from the pharma industry.

    If I know your chance of dying in the next 10 years is, say, 3%, based on actuarial tables, but pharma/medical “research” data lets me post it at, say, 12%, then I can presumably charge 4x the premium to insure you, and pocket a hefty margin.

    Or would that be a cynical thought …

    Reply
    1. Dr. Malcolm Kendrick Post author

      I did question this, at one point and was told that they are not allowed? to look at the research in detail. They just do their calculations based on the guidelines. I have not idea how accurate this is. In general terms no-one will ever move into another area and question the ‘experts.’ It is considered bad form.

      Reply
      1. Lucy

        Okay this is just my opinion. I live in the US. It’s peer pressure. If you say anything, like I don’t think cholesterol causes heart disease, or maybe bypasses and angioplasties are in a large part useless, people ostracize you and your job might go away. People here worry alot about rationed care, but don’t understand that too much intervention is a very bad thing. The public might accuse the insurance company of rationing. There might be lawsuits. I hear little things now and then little noises that things are changing. Different people are starting to talk and talk and talk. One day, I believe the flood gates will open. It’s just like the Galileo incident. People were too afraid to take on the prevailing wisdom of the day, but eventually the truth came out. In a large part that Galileo incident wasn’t even about the church, it was politics. It’s just more of the same in modern clothes.

    2. tw

      An American can correct me, but I think the issue is the Insurer can force you to take drugs in order to “reduce” your risk of a more expensive event. So the question will be: is it cheaper to make the patient take these expensive drugs to reduce risk of a more expensive future event, or cheaper to leave them alone and raise premiums.

      Reply
      1. Jennifer

        tw.
        I feel we are in a dilemma here in UK when using the NHS, in regard to being prescribed the ‘in’ drugs, regardless of need or want.
        I have developed a minor condition over the last 2 weeks, which I would like to discuss with my GP. My husband, aware of my reluctance to visit the surgery, suggests I google the problem. Not wishing to do so, suspecting I know what is going on….instead, he googles….then reads to me what he has discovered ( which equates with what I suspected, having studied A & P for years). I will still refrain from making an appointment as whatever I have will be blamed on my decision to stop the meds I took for more than 10 years, and which had made me so poorly.( I know, because that is what happened on my previous visit, where the condition was a self-limiting, one-off, and unrelated to cholesterol, B/P, glucose).
        I do not wish to be lectured at by GP or Nurse Practitioner….I would like a grown-up discussion…..but that seems out of the question. Or do I have to go private? Or do I stay put, and get on with my busy life, and risk developing into an expensive problem.?
        I have lost faith in the NHS, for the very reasons that bloggers here are pointing out….that the medics are failing to look at the patient in front if them, but instead thinking about the drugs being suggested on the computer screen in front if them.
        The NHS is our insurance policy, just like the American private insurance business …but, do either systems have the right to force us to be re-medicated on what may well be a false premise, (cholesterol, B/P, glucose), conveniently distracting us from any current problem? The new condition may take a degree of “thinking through the problem”, so it is much easier to dish out pills by suggesting the condition is likely due to refusing to take said toxins.
        Heavens above, I get more cynical, and less trusting, by the month.

      2. Lucy

        As far as I know, the insurer cannot force you to take drugs. I live in U.S. They can make your life a living hell. I have been spammed with robo calls to get all these tests. I am considered non compliant because I won’t take a statin. I tried and it made me sick. My cholesterol, last time I checked was 280 and LDL was 200. My triglycerides were good. My solution was to stop checking cholesterol. There’s nothing I can do anyway. I won’t take the Statins and other drugs as they do more harm than good. So why should I even know my cholesterol level?

  10. gillpurple

    Another cracker, Dr K. Thank you.

    Shame on the American Heart Association for conveniently widening the definition of FH, just as Big Pharma are out for their next massive lot of bumper profits with the next wonder drugs. What an amazing coincidence – otherwise known as organised crime in action. Brazen trickery, managing to keep the statin market going and getting a very expensive medication launched which has no proven benefit.

    Is this possibly where things might backfire in a big way? Could things come unstuck on this one? Injections every two weeks – no chance then of just not popping that pill if patients notice serious side effects, they’re stuck with the stuff doing heaven knows what in their bodies for two weeks. Something big needs to happen with this dangerous thinking about cholesterol but I hope it’s not going to involve lots more misery and damage to patients – many of whom don’t know yet that they are ‘sick’ and ‘need’ treatment. Big Pharma’s are getting bolder and more brazen, and every time they seem to get away with it because the regulators and NICE are absolutely useless and toothless – and some might say they are actively colluding.

    Reply
    1. Stephen T

      Gill, I also wonder if this might not backfire on them. Not many people will want injections every two weeks. And if these new drugs are super efficient at reducing LDL cholesterol, then perhaps the side effects will hit home quickly and be associated with the injections. I think the evidence of problems might well be apparent a lot quicker than with statins. Suspicion about them exists before they even begin to be used.

      The drugs industry is clever, but it’s also greedy and they might just shoot themselves in the foot. Of course lots of harm will be done before any ‘mistake’ is acknowledged.

      Reply
      1. gillpurple

        Stephen. Yes, a possibility of serious side effects being more obvious quickly. Worrying that that even more healthy people risk getting caught up in this, especially as the Pharma’s seem to have neatly found a way of not affecting the statin market as well.

  11. David Bailey

    Malcolm,

    I am wondering what you actually do if an apparently healthy person turns up at your surgery and they turn out on testing their blood to have FH – at least of the heterozygous type (have you ever met a homozygous FH patient?).

    Do you offer them statins, or try to encourage them to ignore the ‘problem’?

    What about the homozygous patients – presumably their cholesterol is sky high – so do they live into old age?

    Reply
  12. Soul

    Just a hunch, and hope I’m wrong, but I could see adventurer Bear Grylls making TV pitches for this then. We have many pharmaceutical television commercials shown in America and he a popular personality here, one that has talked about having a genetic condition for high cholesterol, a condition he blames on causing the passing of his father and grandfather early due to heart disease, and is concerned about his sons having the condition.

    Interesting though about broadening the possible number of people that would be eligible for PCSK9 inhibitors. It wouldn’t surprise me additionally if the original theory turns out to be correct also, that being PCSK9 inhibitors moving into the traditional statin market since most statins are no longer under patent.

    Last year or so when it was announced that the market for statins would be broadened, I thought that was due to people being able to change their cholesterol numbers through diet. Before it was often said by health care officials that diet played little role in being able to change cholesterol numbers. Then lower carb dieting found that to be wrong. That is my theory on how that came about anyway.

    Reply
  13. Björn Hammarskjöld

    It’s interesting how many CVDs can be prevented for FH’s in Sweden?
    We have 10 M inhabitants, 0,5 % have FH i.e. 50 000.
    Below th age of 50 there were 200 deaths in CVD in the whole of Sweden during 2014.So the amount of people with FH saved would be approximately one person per year at a cost of 100 000SEK/person or the cost of 5 billion SEK.(0,6 b$)
    The benefit is not even measurable. so the cost is 0,6 b$ divided by Zero = infinity.

    Reply
  14. Eric Hirschorn

    I saw on the cardiobrief.org site an article on the guidelines for triglycerides about to change. A measurement of >100 mg/dl will be considered high, down from the current 150 mg/dl. Any new “miracle” pharmaceuticals for lowering triglycerides coming out soon ?

    Reply
  15. ellifeld

    I’m wondering about those with real FH, do they die much younger than others or suffer the consequences of having FH, like heart attacks, shortness of breath? or something associated with very high cholesterol.

    Reply
      1. Stan Calderwood

        It is the old adage…. “follow the money”….. what is the issue with killing the masses, when there is such vast profits at stake? I sense espceially in the USA on commercila matters, Joe public is just money fodder for big business… especialy in big food and big pharma. And if TTIP happens, we can assume big pharma will sue NICE if they try and stop them…

      2. Old fogey

        Meaning that the medical establishment had the results of a natural experiment showing that high cholesterol levels had no effect on mortality all along and yet insisted that people be so concerned about the issue that they changed their diets and took dangerous medication. Absolutely mind-boggling. The whole “preventive medicine” edifice should start imploding once people start thinking about the usefulness of recommendations made by “the experts” about diet, PSA testing, mammographies, etc.,

      3. Janusz Bieńkowski

        Do you have proof for that or just there is no data indicating that they will live shorter ?

      4. Björn Hammarskjöld

        It’s easy to find that people live longer with higher TC levels.
        Just look at the TC level in healthy persons above 65 years of age.
        >90 % have a level of TC above 5 (200). Those with a lower TC have died off before they became mature of age and TC.

      5. David Bailey

        GOOGLE turned up this remarkable document:

        http://www.bmj.com/rapid-response/2011/11/02/benefits-familial-hypercholesterolaemia

        “more surprising is that according to the The Simon Broome FH Register Group,
        the mean life expectancy in FH is as long as for other people; more die from
        CHD at a young age, but fewer die from cancer and other diseases later in life.”

        I imagine a lot of people are quite scared when told they have FH, so a blog devoted to exposing some of the myths here might be very useful.

      6. Dr. Malcolm Kendrick Post author

        it is only a remarkable document if you believe that a raised blood LDL cholesterol is, in any way, damaging to human health. I exclude homozygous FH from this. But if any substance in your blood ends up around ten standard deviations from ‘normal’ you will die.

      7. mikecawdery

        While I am sure that you already know the massive literature base that supports your view,
        David Evans has got together some 500 references in his new book. (kindle cost £1) This is well within the finances of those who want further information. “Statin Toxic Side Affects” Personally I hate “Side”. Side effects can be good or bad. The official EMA (Old EMEA) is “Adverse”

      8. Bob Tridgett

        Dr Kendrick could you provide a link to this data I would be most interested to read it. I’m not a medic so it would have to be outside of Pub Med. Thank you.

      9. mike_cawdery

        pubmed is open for anyone to search and read the Abstract and if OPEN ACCESS anyone can download the entire report.

      10. Dr. John

        Malcolm,
        Great article, thank you. What specific level (xxx mg/dL) of LDL is threatening? For those above this level, does medical treatment do any good?

      11. Dr. Malcolm Kendrick Post author

        I don’t know, for sure. My friend’s mother, aged 84 and completely fit and healthy has a total cholesterol of 13.4mmol/l. I know of many people about 10 who are above seventy. My own view is that you need to look at blood clotting factors in association with FH. LDL is a co-factor in platelet activation.

      12. Lorna

        Hi Dr Kendrick, you suggest that blood clotting factors could be a significant element of identifying CVD risk in FH. Could you advise what one would look for to ascertain this risk in a typical NHS full blood count report (if indeed it is included)? Thanks for all your commitment to truthfulness and for your integrity.

    1. David Bailey

      Malcolm,

      I am curious to know what homozygous FH does to people – where, in effect they get a double dose of FH. What sort of cholesterol levels do they reach, and what harm does it do them.

      Of course, anything – even water – is poisonous at high enough levels.

      Reply
      1. Dr. Malcolm Kendrick Post author

        They die of heart disease very young, generally. However, the ‘disease’ they get is nothing like general atherosclerosis. They also have major issues with blood clotting etc. People have used them to vilify cholesterol, but that would be like vilifying water because, if you drink too much, you die.

  16. Dr. Göran Sjöberg

    All this lucrative “nonsense” about “evil” cholesterol dates back to the time, about 60 years ago, when Ancel Keys was setting the scene by propelling the idea that it was the dietary fat and cholesterol that was THE culprit behind high blood cholesterol values which in turn was claimed to be the “actual cause” behind the increasing numbers of heart failures. The incredible cholesterol lowering medical business of today was just a logical outcome of this fundamental misconception. (By the way, this will be the main theme of the second hour of my December 10 talk about LCHF as a way to regain health when seriously stuck in the metabolic syndrome.)

    This 60 year myth has now boiled down to the one single statement (the last bastion?) about the dangers of saturated fats in our food. Basically, this “stupid stance” has today been blown to pieces by a number of people and one of the most recent is the science journalist Nina Teicholz who surprisingly had a paper published in the BMJ a while ago.

    http://www.bmj.com/content/351/bmj.h4962

    To my utter dismay i now read about the total corruption of the established ” nutritional science” when 180 “prominent” official advocates of thie official stupidity about the saturated fats have signed a letter requiring the “complete withdrawal” of Teicholz’ article.

    http://cspinet.org/bmj-retraction-letter.html

    Reply
      1. Barry

        Mike,
        The evidence of the dangers of cooking with vegetable oils has been around a long time – which I suspect you are aware of. These press articles annoy me when they present old knowledge as new. The press cherry pick to suit whatever is deemed to be suitable at any given time – and of course as directed by those that own them.
        There are many research papers and books that cover this one way or another but for a good overview that includes the oils that will be used to meet the new trans fats FDA ruling I recommend Nina Teicholz’s book The Big Fat Surprise ISBN 9781451624434. It’s an interesting read.

      2. mike_cawdery

        Barry

        Already have the Teicholz book. The newspaper article was based on the recent research of a Leicester professor

    1. Frederica Huxley

      If I recall, Ancel Keyes cherry picked the results from 7 out of 23 countries to ‘prove’ his hypothesis! The result was that this research, without corroboration, was used to completely change the path of nutrition with demonised saturated fats, and ‘healthy’ low fat processed foods. The pharmaceutical industry then developed the drugs to ‘cure’ high cholesterol – the rest is history, and an increasingly sick population.

      Reply
      1. celia

        John U, thank you for the link to Nina Teicholz’ web page. I do hope the BMJ will not fall into the trap of forcing her to retract her article.

    2. Dr. Göran Sjöberg

      Mike
      In principle I guess you are right but I guess the impact of a TV-broadcast is much more devastating on the general public than an article in the BMJ so the “establishment” is then using “all their power” to get a retraction.

      Frederica
      Yes, Keys started with the obvious “falisifaction” and was scientificallyand shamefully rebutted but he was more of a stern, ruthless fighter than a person scientifically inclined so he returned full force and won the game and entered into the “lime light” rather soon after getting the AHA on his boat. This is a fascinating story which I will dwell on in my talk.

      John
      Thank you for the link to Teicholz’ response. Reading that response and not to recognise her integrity as a journalist of science then you must probably belong to the same bunch of second rate “scientists” as those 180 who signed the letter and such people, per definition, do not own any integrity. Integrity is the actual hall mark of the very first class journalists or scientists. Gary Taubes is by the way, as a journalist of science of the same caliber, a true forerunner to Teicholz on this subject.

      Reply
      1. Dr. Göran Sjöberg

        Talking integrity, I should of course have mentioned medical doctors of integrity who are equally rare but worth the same esteem and that is why we all dwell here on Malcolm’s blog – aren’t we 🙂

      2. mikecawdery

        Goran

        TV-broadcast is much more devastating on the general public than an article in the BMJ

        How very, very true and all the scammers in Government, Big Pharma, Big Food and the media know it and use it to the full. The world is now a most untruthful place and getting worse. Today’s World Bank(WB) statement that 1% of the world population owns 50% of the wealth. No doubt that the members of the WB directorate are in the 1% – hypocrites all!

  17. Bryan Hemming

    Wihout wanting take any credit away from the doctors, who are responsible for prescribing the drugs, patients themselves must bear some of the blame for their belief in what is to often being revealed as quackery.

    Far too many, even well-educated people, believe any and all illnesses can be treated with pills. Told the best thing would to start exercising and eat more healthily they still expect a prescription. Without one, perhaps they feel doctors are not taking them seriously, and could even be accusing them of malingering. A lack of education on health matters, from a very early age, is as much responsible as anything. Added to that, an abundance of adverts on TV for unnecessary, non-prescription medicines, tonics and remedies only serve to increase our trust in boxes and plastic bottles. We are being prepped from the cradle for lives on medications, however healthy we might actually be. Brainwashed into thinking diet supplements packaged and sold like medicines will make us even healthier, no matter how healthy we may already may be, we obediently queue up at cash registers like lambs being led to slaughter,

    We have to realise that big pharma’s objective is not to kill the cash cow by curing illness, but to keep it at bay enough for the patient to be able to make regular trips to the surgery and chemist. In plain-speaking, it is big pharma’s job to find ill-health where none exists. Any side effects the medicines may cause serve as lovely bonuses as yet more pills can be prescribed to relieve them.

    Having said all that Dr. Malcolm Kendrick is doing an amazing job to make up for the lies and misinformation cynically being peddled by massive global corporations milking national economies at the same time as keeping many the ill and suffering away from the health they could just as easily achieve by altering their lives in a few simple ways.

    Reply
    1. David Bailey

      “Told the best thing would to start exercising and eat more healthily….”

      Ah but what is healthy food? Most people have resisted all the efforts to wean them off saturated fats and on to carbs, and now we know they did the right thing! Likewise, the demonisation of salt seems to have been misconceived:

      http://www.scientificamerican.com/article.cfm?id=its-time-to-end-the-war-on-salt&print=true

      I think the average man in the street has made a damn good job of eating healthily by ignoring medical advice!

      Reply
      1. Dr Liz Stansbridge

        The man in the street ignores. Yet what he ignores is the real way to health:
        Eat less carb, ignore exercise and all other dietary advice.
        Has done me a world of good.
        Believe me I have tried it all….low fat, low cal, fitness trainer, gym membership!
        All to no avail.
        Low carb has sorted my DM and my weight problem. I can’t put on weight if I try.
        I feel 20 years have been taken off me, at the age of 57.
        It’s not difficult, and yet…. it is so difficult.
        Get off carbs. All else falls into place.
        Can’t post my before and after pics here. It tells a tale!
        And the weight stays off without trying. That’s the incredible thing to me!

      2. Hugh Mannity

        Define “eating healthily”.
        Depending on who you ask, a healthy diet is vegan, low-fat Mediterranean (real Mediterranean is not low-fat and includes large quantities of processed meats — salami, mortadella, ham, other sausage, etc.), vegetarian, paleo, fruitarian, etc.

        The truth is, there’s no single perfect human diet. We’ve all got slightly different metabolisms and are in different stages of health. Dietary needs change with age,state of health, gender, and activity levels to name just some of the complicating factors.

        Exercise is also a variable. How much, how often, and to what intensity depends on all sorts of conditions. Blanket statements such as “everyone should walk for 20 minutes 3 times a week” are useless to both a marathon runner and a paraplegic.

        We can’t rely on the “experts” to define what’s best for us. We have to do the research ourselves.

        The bottom line: None of us are going to get out of this alive, we just have to make the best of it while we can.

  18. Jean Humphreys

    Ah the familiar melody sung by the moving goalposts! When I was ittle, doctors used their education, intelligence and experience to make (or, often, not) diagnosis. There was not a lot they could do though. If cutting, nuking or penicillin did no good, you were pretty much stuffed. Now there are so many tests, down to a molecular level, and so many drugs that are chucked out by people with tunnel vision, who don’t see the harm they do alongside the adjustments of the readings. Are we any better off? I don’t think so.

    Reply
  19. Bill

    Since a simple genetic test is available, why would doctors diagnose FH by LDL level alone, and why would insurers, whether NHS or US companies, pay to “treat” FH without requiring a positive genetic test?

    Also, if it’s true, as Uffe Ravnskov has argued, that those with FH suffer increased risk of premature CHD but decreased risk of later life cancer, why would doctors “treat” FH in older or even middle aged people, for whom FH appears to be protective?

    (I’m granting the assumption that the “treatment,” i.e.., lowering LDL, helps in the first place.)

    I suppose the answers to both questions are economic and political and not medical in nature.

    Reply
    1. Lorna

      Perhaps we ought to be thankful the NHS does not use a ‘simple genetic test’ for heterozygous FH: imagine then the pressure to take statins in all their evolving manifestations, the hand-wringing and the smiles as health/travel insurance go up and big pharma get the cash.

      Reply
  20. Anne

    But they don’t even measure LDL directly, at least not in the UK. They just use the Friedewald formula which gives an inaccurate LDL if a person has low triglycerides, might be inaccurate anyway even if it meant anything !

    Reply
    1. Bob Niland

      Anne: “But they don’t even measure LDL directly, at least not in the UK. They just use the Friedewald formula which gives an inaccurate LDL if a person has low triglycerides, might be inaccurate anyway even if it meant anything !”

      In the AHA’s paper
      http://circ.ahajournals.org/content/early/2015/10/28/CIR.0000000000000297.full.pdf+html
      on getting the PCSK9 money train rolling, their expanded definition of FH hinges on four measures, and every one of them leads off with:
      LDL-C ≥…
      The paper of course is also rife with worship of the failed Lipid Hypothesis:
      “…given that lifelong exposure to elevated LDL-C levels is the cause of ischemic heart disease…”

      There is no mention of simply testing LDL-P, Lp(a) or ApoE polymorphisms actually implicated in FH. We do not need to guess based on a 60-year-old approximation that is the cardiological equivalent of phrenology.

      For those unfamiliar with the dogma problems here, LDL-C and TC are the top two usually useless measures from the standard lipid panel, but the two that most MDs focus on. And yes, the coarse approximation that is LDL-C is extra useless when low carb (which routinely results in low TG).

      Reply
  21. mikecawdery

    J Clin Endocrinol Metab. 2015 Aug;100(8):3140-8. doi: 10.1210/jc.2015-1520. Epub 2015 Jun 1.
    Praluent Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial.
    http://www.ncbi.nlm.nih.gov/pubmed/?term=ODYSSEY+Journal+of+Clinical+Endocrinology+and+Metabolism

    Apparently Praluent is stated to be a natural human molecule. How come it is patentable? Have I got this molecule?

    OK so it lowers LDL-C. So what? Where are the actual clinical benefits such as all cause mortality? Nothing at all
    Incidentally, as far as I can judge from current research, LDL-C as such is old hat. Triglyceride/HDL ratio and VLDL are the important factors. Particularly as the “fluffy” fraction of LDL-C is important in the immune system. This may account for low LDL(±?)C being associated with poor recovery in infections.

    Furthermore in Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial (http://dx.doi.org/10.1093/eurheartj/ehv028 1186-1194 ) It is certainly effective in lowering LDL-C but surprise, surprise but Like Benecol there is NO EVIDENCE of CLINICAL BENEFIT. So far as I can judge from the EMA information no clinical evidence has been presented but then everything seems to be for “registered users only”

    I also found from the EMA that “Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

    – in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
    – alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

    It seems that it does not necessarily replace statins – just compliments them (same adverse reactions) plus increased polypharmacy with even more adverse reactions, at massively increased cost

    This introduction of a new drug (a natural human molecule??) at huge cost would seem to the final nail in the NHS financial collapse. With the general population convinced that cholesterol is the devil incarnate and beginning to realize that statins are dangerous, they will all demand this new “wonder” drug.

    I also found an article on the payment to GPs, under the QoF formula, was based on points achieved. As many as 20 points @ £156/point for each MI patient put on statins.. Trying to locate article in question.

    Reply
    1. Stipetic

      Hi Mike,

      The EPAR (European Public Assessment Report) for Praluent can be found here: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003882/WC500194524.pdf

      If you’re interested in how Praluent was reviewed by the EMA and what studies were submitted, it’s all there.

      Just went to the clinical section. Here’s a summary: The alirocumab clinical program consists of 11 clinical pharmacology studies (10 completed and 1 ongoing), 7 phase 2 studies (5 completed double-blind and 2 ongoing open-label) and 17 phase 3 studies (5 completed double-blind studies, 9 ongoing double-blind studies, and 3 ongoing open-label studies).

      Regarding endpoints, the assessors had this to say: In all phase 3 studies, the primary endpoint was the percent change in calculated LDL-C from baseline to week 24 in the intent-to-treat (ITT) population. The percent change from baseline for ApoB, non-HDL-C, Total-C, Lp(a), fasting TG, HDL-C, and ApoA-1 was incorporated as secondary efficacy endpoints.

      The assessors seem to know that hard endpoints are being avoided, but find the risk-benefit to be acceptable: Finally, an important limitation of the dossier is the lack of cardiovascular outcome data. Although reduction in LDL-C is considered to be a strong surrogate for CV risk reduction, this is mainly based on outcome data obtained with statins. Data from the recent “IMProved Reduction of Outcomes: Vytorin Efficacy International Trial” (IMPROVE-IT) indicates a moderate CV beneficial effect of ezetimibe, a different therapeutic class than statins, thus strengthening the value of LDL-C as a surrogate parameter, but this remains to be confirmed with alirocumab as a member of the new class of PCSK9 inhibitors. Although no signs of a detrimental effect were detected, the number of CV events and deaths were low and therefore no conclusions possible. A CV outcomes study in patients who have experienced an ACS is already ongoing.

      There you have it. Approval was entirely based on soft endpoints (“markers” of disease).

      Reply
      1. mikecawdery

        Stipetic

        Many thanks for the link.

        Your summary seems to give the real gist of the document so I will leave downloading it till I cool down.

        the primary endpoint was the percent change in calculated LDL-C from baseline to week 24 in the intent-to-treat (ITT) population. The percent change from baseline for ApoB, non-HDL-C, Total-C, Lp(a), fasting TG, HDL-C, and ApoA-1 was incorporated as secondary efficacy endpoints.
        And
        The assessors seem to know that hard endpoints are being avoided
        and
        Finally, an important limitation of the dossier is the lack of cardiovascular outcome data

        As regards the IMPROVE-IT study I made a detailed comment on a previous Dr Kendrick blog. I hope that he will give his expert assessment in a future blog.

        Needless to say, I found that the study added little other than extensive statistics to the efficacy of ezetimibe on its own.

        There are so many studies that show LDL-C, (particulary the “fluffy” fraction) is vital for an effective immune response to infections that I discount “statistically demonstrated” benefits.

        The problem lies in the fact that two totally independent but increasing “measurements” when regressed in a mathematical algorithm will be “mathematically associated” – maths does not distinguish between true metabolic associations and independent associations – just numbers.

      1. mikecawdery

        Barry

        BS baffles brain comes to (f) mind

        A well used quote which unfortunately can often be used w.r.t the medical establishment’s public statements. Thank goodness for those like the eminent Dr Kendrick and colleagues who so brilliantly demonstrate the BS of their “edicts”.

        I really despair of them!

    2. joanne mccormack

      Mike, the QOF paymant for post MI patients is the least of it. The swathes of patients on statins with no previous cardiovascular events is astounding, and the fear of patients and doctors of stopping them shows how brainwashed we have become as a society. I believe they do more harm than good, I am relieved that my husband and mother do not take them, even though they have been advised to do so, but my stance is rare. I am pretty certain that if I refused to prescribe a statin post MI that the patient would think I was mad and I would be likely reported to the GMC. I don’t do it for the money- I am salaried anyway now- but to protect my career. I tell patients the controversy over statins, I direct them to sensible resources on the internet and sometimes they see the light. It is an enormous task to tackle with 60% of over 70s being on them.
      Having re -read what I have written I have a new idea- I could refuse to prescribe as a conscientious objector and direct them to a doctor who does prescribe? Like the Catholic doctors who used to refuse to prescribe the pill.
      These new drugs leave me speechless. I have read the other posts and have nothing to add.

      Reply
      1. Paul Helman

        I do pretty much as you do in your practice. However your conscientious objector idea is quite intriguing. We do now have a young cardiologist who has an interest in “lipidology” and, in fact I did see him myself as I have a type of LDL uptake defect and can achieve total cholesterol levels of a bit over 400 off STATINs on my ketogenic diet. He is working on setting up a lab for more sophisticated lipid and genetic testing. I found him quite sympathetic to my ideas and open minded. He agreed as to the absurdity of our ” normal” cholesterol range and I generally have been forwarding your blogs to him. I have been reassuring patients that the human physiologic ” bell curve” 80% range is more like 150 to 250 and the nice association between longevity and higher levels although not cause and effect it does point to the physiologic need for cholesterol and the normal rise with age. Regards, Paul Helman ,MD Skokie,Il

        Sent from my iPad

        >

      2. Joanne McCormack

        Thanks Paul. I’m trying to open the minds of my colleagues and patients to independent thought. We used to do it before and many of us have temporarily lost the ability.
        I have another great challenge this week. A crazy official dietary guideline for parents I have been asked to comment on in my role as a children’s safeguarding doctor. I can say it is
        nonsensical and unsafe and will lead to obesity in many children not yet obese, and worsen pre existing obesity. I will blog about it and about the response I get.
        Joanne
        http://www.healthylivingsite.me

      3. paul helman

        I have been rereading Zoe Harcomb’s 2010 book and she was discussing similar retrograde and quite ignorent guidlines which have to a large measure been dictated to Dietary Associations by mega food companies to which they are finanancially dependant.Paul Helman,M.D.Skokie/Wilmette Illinois.

        From: Dr. Malcolm Kendrick To: helman_paul@yahoo.com Sent: Saturday, August 6, 2016 10:09 AM Subject: [New comment] Changing the definition of Familial Hypercholesterolaemia #yiv5605851297 a:hover {color:red;}#yiv5605851297 a {text-decoration:none;color:#0088cc;}#yiv5605851297 a.yiv5605851297primaryactionlink:link, #yiv5605851297 a.yiv5605851297primaryactionlink:visited {background-color:#2585B2;color:#fff;}#yiv5605851297 a.yiv5605851297primaryactionlink:hover, #yiv5605851297 a.yiv5605851297primaryactionlink:active {background-color:#11729E;color:#fff;}#yiv5605851297 WordPress.com Joanne McCormack commented: “Thanks Paul. I’m trying to open the minds of my colleagues and patients to independent thought. We used to do it before and many of us have temporarily lost the ability. I have another great challenge this week. A crazy official dietary guideline for pa” | |

      4. mikecawdery

        Joanne.

        but to protect my career.

        A common response I am afraid. Is it not disgraceful that doctors are threatened in such away when there is a huge database of studies that provide contrary evidence to the cholesterol hypothesis?

        The medical establishment (including the GMC) seems to have sold out to Big Pharma, or as Prof. Gotzsche put it “to Organized Crime”

  22. annielaurie98524

    After the Martin Shkreli fiasco, can anyone still believe that ANYTHING is too brazen for the Pharma slimeballs to do? I’ll make a prediction. No, two predictions. First, other Pharma folks are probably smacking their foreheads right now, saying, “Duh! Why didn’t we think of that with our (whatever) drug?”. So copycats will follow. Second, when the profits from Repatha and Praluent are still not enough to satisfy their owners, they will broaden the definition yet again.

    Reply
  23. Anna

    It seems that in the US we are moving slowly but inexorably to a state of medical fascism. More vaccines are being invented, there is hype and scare, and the logical end will be coerced vaccination for the entire population from cradle to grave.
    ***
    I find that most doctors are very nice people. But I am afraid they are cruising for a bruising. Science is being increasingly corrupted in a few fields, but medicine is the big one that really affects lots of people. Looking at the state of the world, it is hard not to think that matters may be coming to a head, and what will be the fallout? Will the pendulum swing away from science entirely? What if there is a social backlash? Doctors, nice though they are, are the frontmen and women for a huge scam, draining the wealth of society while promoting illness rather than health. In the end, they are supposed to advocate for the people, not be blackmailed sellouts for drug pushers, which is what they are.

    People are generally mentally fragile. They are helpless because it is only a minority trait to think for oneself, or even to let someone else do the thinking for them if it leads to holding lone opinions. Most people resist it, and that certainly includes doctors. What they want is the comfort zone of a group belief. Therefore, the population at large are sitting ducks and probably always have been.

    Reply
    1. Dr. Göran Sjöberg

      “It seems that in the US we are moving slowly but inexorably to a state of medical fascism. More vaccines are being invented, there is hype and scare, and the logical end will be coerced vaccination for the entire population from cradle to grave.”

      Anna,

      This is what I also read in the latest post of Dr. Mercola

      http://articles.mercola.com/sites/articles/archive/2015/11/08/vaccine-exemption-updates.aspx?e_cid=20151108Z2_DNL_art_1&utm_source=dnl&utm_medium=email&utm_content=art1&utm_campaign=20151108Z2&et_cid=DM90157&et_rid=1204486409

      He uses the following phrasing for a subhead

      “Militarization of Public Health Policy and Medical Fascism”

      Well, this seems to be going on all over the world!

      Today, e.g., I heard on the public radio i Sweden that two reporters had met clandestinely with whistleblowers from our FDA who told them about how they were actually forced by their managers to hide any warnings about the drugs to be approved. As one stated: “My work on the applications from Big Pharma would be much easier if I was just given one stamp with the word OK to be used by my managers.”

      Reply
  24. Barry

    Well, they almost got the names right. Repugnant and Fraudulent would be more fitting. What do they take to dream up these names?

    There seems to be nothing that Big Pharma will not do to extort money from medical intervention. Like Goldman Sachs in the financial world they are the vampire squid of the medical world. What is truly horrendous is that none of this could happen without the backing of the very organisations that are supposedly there to protect the public from misconceived and faulty dogma but instead actively support it.

    How do the elite, especially those with a medical background, of the FDA, ADA, AHA, NCEP, NHI, NHLBI and NIH plus similar bodies around the world manage to avoid recognising the obvious to when it comes to health? They are not only tripping over the truth but falling over it into the sea of denial and still pretending that it is not there. These are not stupid people, although their behaviour certainly suggests it. Questioning the conclusions of science is the bedrock of scientific advancement but these people dismiss logic and reason as if they are the ramblings of a drunk.

    PSCK9 inhibitors will destroy health (Interfering with gene expression involving such a vital substance as cholesterol is not going to end well.) and health care budgets if they are prescribed in anything like the quantities that Big Pharma desires. Health care budgets are already inadequate for the problems we face such as diabetes bought on, in no small part, by the idiotic diet advice which far from preventing CVD problems massively contributes to them.
    The impact on US health services will be a total disaster. Americans are already reeling from the imposition of the Affordable Care Act (Very Orwellian that, a double plus good from the Ministry of Truth.) which is anything but.

    Never has it been more important to question everything and educate yourself about health matters.

    As Dr Liz says “Don’t get sick”

    Reply
  25. Sue Holyoake

    For me, this was the final straw. I can no longer just sit here seething. It may not do any good, but the Daily Mail investigations unit is asking for suggestions for future ‘scandals’ so I have just emailed them with suggestions where to start their investigation into this terrifying truth. Might not do any good, but makes me feel slightly better. On a personal note, I have successfully stopped a family member from being damaged by statins, so at least have achieved something. Thanks Dr Kendrick for all that you are doing on our behalf.

    Reply
    1. mikecawdery

      Sue

      Congratulations. I don’t know whether the following link will work

      It shows one poor man’s devastated calf muscle from statins.

      Reply
      1. David Bailey

        I wish I knew why statin damage is sometimes reversible, and other times permanent. I recovered completely from mine – even though it was in a leg that was weakened from polio – while others seem to end up permanently disabled.

        Of course, there isn’t much real research into why this is, because the disease (statin poisoning) isn’t supposed to exist, or is supposed to incredibly rare.

        My only advice to people who find themselves in this position, is to do what I did – take painkillers so as to be able to exercise the affected muscles (progressively longer hill walks and bike rides in my case). Muscles do respond to exercise, and it might help some that are struggling after taking these wonder drugs.

        I guess the other piece of advice, is don’t take the wretched stuff to begin with, or at least stop at the first hint of problems.

  26. Peter Watson

    I have just read one of the blog links attached to your article – the going-lo-co blog,written by a US author who is trying to avoid statin therapy (statination). I was struck by how very different the approach of US residents (that is if she is representative) to health risks is to UK residents. She has carried out her CVD risk test based on the AHA risk assessment and her score was low risk, yet she refers to previous and forthcoming appointments with a cardiologist and wishes more information on whether PSCK9 inhibitors may be appropriate for her. No wonder pharmaceutical companies are doing so well! If you aren’t sick, stay away from doctors and hospitals, as you are just wasting everyone’s time!

    Reply
    1. David Bailey

      Never mind the waste of time, if you use the medical services when you are not sick, it is quite clear to me that you put your health in danger!

      You may end up taking a drug such as a statin (as I did), that is very likely to do you harm.

      You may accept lots of screening tests, which involve stress and the danger of false positives of various sorts.

      You may miss out on the joy of being out in the sun.

      Etc.

      Ultimately, you will die whatever you do!

      Reply
      1. Jennifer

        David, you are so correct.
        Either way, it is sensible to stay away from the health business….if you are well and get embroiled in the ubiquitous screening system, you will soon be ill….if you are ill, and seek help, it seems the medics are reluctant to steer away from the conventional approach of NHS, for fear of being admonished; imaginative thinking has no place in modern medicine.
        The screening system has been discussed on this blog, and there are downsides to it. Have you noticed that it is not just driven from within the NHS in UK? We are being bombarded with requests from the Big Pharmacies ( USA owned usually) enticing us to have this that and the other checked for free? a sprat to catch a mackerel ….
        Before you can consider what is happening, you are tripping off to the poor old GP with your slip of paper showing your ‘shocking’ results. GP must be compliant and prescribe drugs based on the new low thresholds….and while you are there….you will need the bits to operate the medical appliances you have been convinced are essential for your well being! The snazy B/P monitor, the glucose/cholesterol monitor etc. who can survive without them? Don’t worry where to source them….be sure ….. Big Brother Pharmacy has plenty on stock.
        And it gets worse! A 12 year old enjoyed showing off his new smart phone to me….how it monitors B/P, pulse, resps, ad infinitum……catch them young, and they will be worried into the clutches of Big Pharma for the rest of their lives. That child ought to be out in the fresh air, be it sunshine, blustery autumnal frosts, or a foot of crisp wintery snow……not monitoring his ‘health markers’.
        We are breeding hypochondriacs big time.

  27. Stephen T

    Liz, I’m glad you’re doing well, but advising people to ignore exercise isn’t helpful. It’s not significant for weight loss, but it’s good for us in lots of other ways. It may not suit you, but sensible exercise is good for us.

    Reply
    1. PeggySue

      I couldn’t agree with you more Stephen. I’ve been a regular gym goer for 20+ years – nothing too serious, just an hour or so of mid-range stuff – and there have been times when it has been my absolute saviour in recent years. I’m a rather “highly strung” individual and a session of mindless activity seems to clear my head and relax my soul – like being rebooted!

      However, I agree with Liz that it really isn’t for everyone and we do live in a world where “exercise” is held over us all as part of that healthy-lifestyle stick that includes low cholesterol, low salt, low fat etc. It can present such an impossible mountain to many people that they don’t bother with any of it.

      From what I have read of her posts, Liz is thrilled to absolute bits that she feels wonderful these days and has managed to reach this euphoric state without having to exercise (not to mention standing up to the NHS mantra). I took it as a message of encouragement to all those folk who absolutely dread the thought of “exercise”.

      Hope you don’t mind me saying something Liz – I think you are right to feel incredibly proud of yourself. Feeling healthy and happy is everything.

      Reply
      1. Stephen T

        PeggySue, I agree that many people struggle with exercise, particularly if it isn’t something they’ve done for a long while and in some cases haven’t ever done. I’ve always exercised, but in moderation, usually a thirty minute swim or cycle three or four times a week. I think little and often is more sustainable than trying to do lots once or twice a week.

        The problem, as exposed recently in The Times, is that Coca Cola, and its like, spend millions to convince us that we’re fat because we don’t exercise. Nothing to do with all those useless calories that tell us we’re hungry. I’ve always exercised but my weight only changes when my diet changes.

        A sad sight for me is people coming out of the gym or fitness class and then drinking a large bottle of cola, even if it’s ‘diet’. Even sadder when it’s a chubby child given the cola by a well meaning but misguided parent. When they avoid the cola, they go for fruit juice because that’s ‘healthy’ – and packed with sugar. The message is slowly getting out. Sales of fruit juice dropped slightly this year after years of steady increase.

  28. Anna

    Sorry, I appear to have been in a bad mood last night.

    I’m confused about how drug companies get away with such high prices, which, while twice higher in America are nonetheless too high in Europe as well. It is rumored that the Obamacare has a clause denying the govt the right to bargain for drug prices in its medicare and medicaid programs, but presumably the insurance companies can bargain and presumably European govt’s can bargain, so how do they get away with such high prices? Is it only the newly patented ones that are driving up the costs so much? If so, it would seem that we have a psychological problem on our hands. That is, everyone jumps the minute a new drug is available as if it were life and death, which it rarely is (and even then, such as new chemo, it is mostly hope and not reality). Instead, why don’t the insurance companies/Euro governments just sit on their hands a few months and when these new drugs have NO sales, perhaps they will be a bit more reasonable?

    Reply
    1. annielaurie98524

      Sadly, much of the healthcare legislation that gets passed in the US contains provisions like the “no negotiations on drug prices” clause, because legislators that are owned by the pharmaceutical companies insist on inserting such language in order to support the legislation. It is impossible in the adversarial Congresses of the last few decades to get a “clean” bill passed. In addition, we are only one of two countries that allow direct, pharma-to-consumer advertising, with commercials that make folks think they have to have the latest drug for whatever ails them. But much more than consumer demand, it is the FDA-Big Pharma-physician troika that’s responsible for the financial success of new prescription drugs. The Pharma companies sponsor much of the continuing education of doctors. Their reps outright bribe docs on a day-to-day basis. They sponsor much of the research. They “ghost write” articles for medical journals, and get well-known physicians and researchers to attach their names as “authors”. There is a revolving door between the FDA and the Pharma companies (we are currently signing petitions and trying actions to stop the appointment of yet another “Pharma Bro” to the FDA).

      These problems are well-known, long-term, and documented. There are any number of physician “whisteblowers” that have authored articles and books exposing it, some going back 25 years. Why doesn’t it stop? In a word, MONEY.

      Reply
    2. Barry

      Anna,
      They get away with it because the whole system is rigged against the general public by embedded corruption. From the government (government of the rich, by the rich, for the rich), through the revolving doors of the mega corporations and the agencies tasked with regulating them. We, the public, are fleeced from birth to death. We are fed a diet of propaganda via the controlled MSM so that most submit without protest to unjust laws and regulation designed to extract as much wealth as possible from us. Based on our fear of illness/death, there are few areas more ripe for extortion than the medical industry and especially so in the USA where, as Peter Watson noted, the conditioning is such that people belief that medication intervention is a normal part of life.

      The Affordable Care Act is a classic example of industry biased legislation forced through. It started with Obama’s
      “We will start by reducing premiums by as much as $2,500 per family.”
      “If you like the plan you have, you can keep it. If you like the doctor you have, you can keep your doctor, too. The only change you’ll see are falling costs as our reforms take hold.”

      Followed by Nancy Pelossi’s stupid statement of “we have to pass the bill to find out what’s in it”.

      The ACA was not written with the interests of the public in mind but as a means of getting even more money out of them. See who is actually behind it: http://www.thecommonsenseshow.com/2013/12/02/the-shocking-truth-about-who-wrote-obamacare/ .

      So how did it all work out? Not so well – according to the Kaiser Family Foundation:
      Single and family average premiums for employer-sponsored health insurance rose 4% this year over last. The average annual premium for single coverage is $6,251, of which workers pay an average of $1,071; the average family premium is $17,545, of which workers pay an average of $4,955. Deductibles have risen more sharply than premiums. That’s the amount that consumers must pay out of pocket before insurance pays for anything, except for certain preventive services that are covered at 100%. The average deductible for workers with employer-sponsored health insurance who face a deductible is $1,318 for single coverage this year, up 44% from $917 in 2010. By contrast, over that same period, single premiums are up 24% and wages have risen 10%, just outpacing general inflation at 9%.
      Plus http://www.huffingtonpost.com/2013/10/03/health-care-costs-_n_3998425.html

      Do not expect governments to do anything – they are just a front to the real power.

      Reply
    3. mikecawdery

      It is rumored that the Obamacare has a clause denying the govt the right to bargain for drug prices in its medicare and medicaid programs,

      As far as I know this has been the case for some years. It is also true that Big Pharma is totally absolved from responsibility of vaccine injuries. Govt has accepted responsibility and currently has paid out $100s of millions including for autism.

      Reply
      1. Hugh Mannity

        Obamacare is based on Romneycare — the “universal health insurance” program created by the Heritage Institute and forced on Massachusetts while Mitt Romney was governor.

        It made Massachusetts healthcare one of the most expensive in the country. Sure, people have insurance, but find it hard to get to see a doctor as there are is a shortage of primary care (GP) doctors — it’s not worth their while to be in private practice any more. The older ones retire, the younger ones work on salary in hospitals. Without access to primary care, people end up in the emergency room for things that wouldn’t be emergencies if they had primary care.

    4. Soul

      As others have mentioned, it splits both ways with politicians, and other groups that I guess it could be said are pets of the pharmaceutical companies. Maybe better put, many make good money with prescription drugs.

      Not that long ago I remember many complained of Donald Rumsfeld, the former President Bush military advisor for making giant profits off of Tamiflu. Rumsfeld’s story is when the H1N1 hyped scare happened, countries were convinced to rush out and purchase Tamiflu, only to later find out the drug didn’t work against the flu and that it had nasty side effects. Rumsfeld was on the board of Directors for Gilead, the company that manufactured Tamiflu before joining the Bush administration. When he entered government life again he still owned many shares in Gliead, and with the Tamiflu purchases became a very wealthy man. You can read a little about the Tamiflu fiasco here ~

      “Does Tamiflu actually work (and is it safe)?”

      http://www.drbriffa.com/2009/12/11/does-tamiflu-actually-work-and-is-it-safe/

      Of late, in January President Obama made a trip to the country of India with a main purpose of asking the Indian government to put an end to the practice of manufacturing inexpensive medications. Many top charity groups protested greatly over the lobbying by the President.

      A month or two ago, the former head of the new American health care system, the ACA or other wise known as Obama Care, Kathleen Sebilious, a lawyer and career politician, joined the board of Directors for the pharmaceutical company Humacyte Inc. I’m sure she will make good money with this appointment.

      “The Revolving Door: Former US Secretary of Health and Human Services Joins Humacyte Board”

      http://www.nakedcapitalism.com/2015/09/revolving-door-former-us-secretary-of-health-and-human-services-joins-humacyte-board.html

      Reply
    1. mikecawdery

      Soul

      Given that the paradigm (framingham data) on which the current directives are based are simply statistically and significantly WRONG it is incredible that this belief continues.
      Lancet. 2000 Jan 15;355(9199):175-80.
      Port S, Flawed Systolic blood pressure and mortality based on Framingham data..
      and
      INTERPRETATION:
      The Framingham data contradict the concept that lower pressures imply lower risk and the idea that 140 mm Hg is a useful cut-off value for hypertension for all adults. There is an age-dependent and sex-dependent threshold for hypertension. A substantial proportion of the population who would currently be thought to be at increased risk are, therefore, at no increased risk.

      But then the Gods know best!

      Reply
    2. Stephen T

      So, the blood pressure target gets dropped even further. Ring any bells with cholesterol? What do you think of the ‘Sprint’ trial, Dr Kendrick?

      Reply
  29. JR62

    “How do the elite, especially those with a medical background, of the FDA, ADA, AHA, NCEP, NHI, NHLBI and NIH plus similar bodies around the world manage to avoid recognising the obvious to when it comes to health?”

    Because those organisations are founded or early infiltrated by big food and pharma. It’s not wise to expect other from those. Follow the money.

    Reply
  30. Ray Davies

    ““It is difficult to get a man to understand something, when his salary depends upon his not understanding it!” Upton Sinclair.”

    He also said: “Fascism is capitalism plus murder”.

    Ray

    Reply
    1. annielaurie98524

      So maybe our Pharma industry is bordering on fascism? His quote on money vs. one’s ability to understand applies to so many areas of science, but especially to the corrupt Pharma industry. Any “inconvenient truths” cam be ignored if they might interfere with the industry’s profits, including whether their products can kill.

      Reply
    2. mikecawdery

      Albert Einstein summed it up perfectly when he said ”Only two things are infinite; the Universe and human stupidity……and I’m not sure about the former”

      Reply
  31. Linda

    Re: Exercise

    Exercise is vital for us post menopausal women to keep our bones strong!

    Exercise is also good for keeping joints flexible and developing good balance to help prevent those slips, trips and falls when older.

    Reply
    1. Old fogey

      The ideal exercise, I believe, is the simplest – walking to the store, washing windows, cleaning floors, polishing silver, playing with children, running for the bus, washing the car, gardening, etc. You don’t need to spend money to exercise, in fact you save money by concentrating on your daily chores. I bet smiling, too, is a good exercise for your facial muscles!

      Reply
  32. Barry

    Elliot,
    “Sorry to disappoint the Obama haters but this was actually done under the Bush administration”.

    It matters not which party is nominally in power as Dr Kendrick says. They are purely a distraction to give the illusion of choice. There is no choice – or none that matters – be it Bush, Obama and whichever puppet comes next the result is the same.

    Obama has done nothing to improve the lot of the average working American. Obama, who is so keen on executive power to push through whatever is deemed important, has done nothing to reduce health care costs or put any form of control over the excesses of Big Pharma.

    Americans are now forced to have numerous vaccinations, which are causing serious problems, and the responsible drug companies are absolved of any responsibility. They win both ways and the public loses both ways as they risk illness, pay the bill for the vaccinations and pay the compensation when it goes wrong. What a crazy system.

    Reply
    1. Flyinthesky

      It’s the illusion of democracy, we change the colour of the bus, we change the operator of the service, we may give the driver a different uniform, but he remains, as does the destination.
      New improved shop front and repackaging of the same products.

      Reply
  33. Anna

    Well, I understand the corruption in the US pretty well, but isn’t the NHS beginning to have financial troubles? How do the various countries in Europe negotiate pharmacy prices? Canada certainly has lower ones than the US.

    Reply
    1. Barry

      Anna,
      Browser crashed during posting of comment. Resending – apologies if it double posts.

      NHS is effectively bankrupt – it has struggled for years to contain costs. It is very top heavy in administration with quite ludicrous salaries and perks for senior management. Many see the current state of affairs as quite deliberate as a means to push the NHS into private hands – but that is another story. Additions of such overpriced drugs as PSCK9 will, of course, do nothing to help and are just another nail in the coffin of what was, and to some extent still is, a good health service. Decades of flawed dietary advice, flawed beliefs as to the causes of CVD etc. have resulted in the unnecessary medication of millions and caused the tsunami of diabetes and obesity which will overwhelm the NHS.
      Regulation of pharmaceutical with the EU varies; here are a couple of links which will provide information:
      https://www.nber.org/papers/w12676
      http://www.hoganlovells.com/files/Publication/41a7b0f3-b653-45b9-a2c8-6a8ee504274c/Presentation/PublicationAttachment/9300f058-5514-40b4-a8dd-057cc1756059/EU%20Pricing%20%20Reimbursement%20Newsletter%20-%20November%202014.pdf

      Reply
    1. mikecawdery

      Thanks for the link.

      A very interesting and thoughtful document. I think that is very much what this and other blogs are about. With so many “new” chronic conditions in health, one wonders if many derive from “shifting baselines” and their adverse results .

      Reply
  34. Jean Humphreys

    BS alert. In today’s Telegraph a small front page piece, with followup inside.saying grand news of a vaccine for cholesterol, for the poor unfortunates who can’t hack statins. Pesky Canines are referred to but it was not clear to me whether they are referring to the new drugs. The research was said to come from Switzerland and was said to involve an injection every three months.

    Reply
  35. Stephen T

    The publicity campaign for PSCK9 Inhibitors is underway. In this morning’s Daily Telegraph they were described as a vaccine for cholesterol. Importantly, it was suggested that an injection could last three months, which will make them much more acceptable than a fortnightly injection. Interestingly, the side effects for some of statins were openly acknowledged, although muscle pain was the only one mentioned. There are probably plenty of people on here who’ve had their concerns about side effects dismissed. It was suggested that some people would take the new drugs and statins! Heaven help those people.

    The report did acknowledge that we need cholesterol, but not too much, and our bodies obviously don’t know how much to make or we get too much from our diet, which even Ancel Keys accepted wasn’t the case.

    Human trials are soon to begin. What will the definition of success be? Mortality, heart attacks and strokes? No, I’m betting it will be reduction of that wicked ‘bad’ cholesterol. It’s kicking a ball into an open goal. I think the Russian doping agency has been put in charge of the tests, so we can rest easy.

    Reply
    1. mikecawdery

      Stephen T.

      Human trial s have already started – see above. The EMA EPARs are already on line (See Stipectic contribution) and they are doing precisely as you suggest.

      As Einstein suggest “human stupidity is infinite” and our “experts” continue to prove him right!

      Reply
  36. mikecawdery

    News but probably not good news!

    A cholesterol-lowering VLP vaccine that targets PCSK9

    http://www.sciencedirect.com/science/article/pii/S0264410X15013201
    Paper can be downloaded.
    http://www.telegraph.co.uk/news/science/science-news/11986981/Cholesterol-vaccine-could-end-need-for-daily-statins.html

    Highlights
    PCSK9 is a molecule that controls the metabolism of low-density lipoprotein cholesterol (LDL-C).

    We have generated virus-like particles based vaccines that induce high-titer antibodies against PCSK9.

    Vaccination of mice with PCSK9-VLPs resulted in reduced lipid levels.

    Macaques vaccinated with PCSK9-VLPs and coadministered statins had significant reduction in LDL-C levels.

    Vaccination against PCSK9 may be an alternative to monoclonal antibody-based therapies

    Comment: And presumably once vaccinated one’s cholesterol level is forever minimzed denying the individual of the long term benefits of high cholesterol but confirming the disadvantages of low cholesterol

    Reply
    1. mikecawdery

      This work on this PCSK9 vaccine is obviously an excellent piece of research.

      My gripe is that this type of research should be directed at a target that is infinitely more useful than lowering cholesterol.

      One gets the impression that “money” is more important than improved health

      Reply
      1. Barry

        Mike,
        Agree completely. Unfortunately useful means different things to us and Pharma. We look for useful medication to treat illness and they look for anything they can get away with to increase profits regardless of benefit or potential harm.
        They obviously see a lot more life in the cholesterol game and will, no doubt, brazenly push it to the bitter end. I fear that the disruption to biochemistry that PCSK9 inhibitors will create may well result in another Vioxx type situation with potentially many premature deaths and, at the very least, significant adverse effects. I hope I’m wrong.

    2. Stephen Rhodes

      Having struggled through parts of http://www.nature.com/nrcardio/journal/v4/n4/full/ncpcardio0836.html it looks like the new drugs solve the ‘problem’ of LDL in the blood by stashing it away in cells that – except in those with the genetic defect on which the drug is based – almost certainly do not need it as they do not have any defects in their intracellular cholesterol homeostasis mechanisms.

      So, a bit like those hoarders of unwanted ‘rubbish’ who occasionally feature on TV when council workers have to empty houses full of rotting tat in black bags, recipients of this drug will be the next experiment to see what happens when all the cells that the drug impacts are given an overdose of LDLs.

      Reply
      1. mikecawdery

        Many Thanks for the link. It seems to be an interesting paper but my gripe is “why waste time and money on a subject that contributes little to health” Indeed on the basis of thhe 700 papers reviewed by David Evans in his three books, the reverse would seem to be the case. My own clutch of papers confirm his findings.

  37. mikecawdery

    Off Topic but may be of interest Not yet in Pubmed
    Effect of PCI (stenting?) on Long-Term Survival in Patients with Stable Ischemic Heart Disease Sedlis,p. M.D., NEJM

    N Engl J Med 2015;373:1937-46.
    DOI: 10.1056/NEJMoa1505532

    CONCLUSIONS
    During an extended-follow-up of up to 15 years, we did not find a difference in
    survival between an initial strategy of PCI plus medical therapy and medical
    therapy alone in patients with stable ischemic heart disease. (Funded by the VA
    Cooperative Studies Program and others; COURAGE ClinicalTrials.gov number,

    Whatever next?
    NCT00007657.)

    Reply
  38. Colombo

    If a doctor tries to warn me of some illness risk I’m in after I consult with him, everyone would say that is the right thing to do.
    If a doctor tries to warn me of some illness risk I’m in after I consult with him, but that risk is completely false and he is lying, everyone would say that is a very bad thing to do.
    If a doctor tries to warn me of some illness risk I’m in after I consult with him, and that risk is completely false but he believes it is true, then we are in a gray area, because some would say he is not lying and others would say he is responsible for misleading.
    The question is, how am I supposed to tell when I’m being told the truth and when I’m being lied to and when my doctor is the victim of a cult?

    Also, what happens when a false belief is married to political power?

    Reply
      1. goransjoberg2015

        I have just finished a very scary book from 1932, “Brave New World” by Aldous Huxley about a future fiction world in which people are “scientifically” and genetically engineered and actually manufactured in test tubes and then systematically nursed and trained by repetition so they will think just the right things and not to disturb the perfect social “harmony”.

        If someone by chance still happens to have some disturbing thoughts they are immediately given a pill with “Soma” which makes them happy again. Most are, by the way, eager to take their Soma pills voluntarily since that “carries them away” on a “happy holiday” for a day or so.

        Although very scary, it is quite a visionary book to my option.

      2. Frederica Huxley

        Yes, my uncle’s Brave New World books certainly deserve to be read again – horribly prescient. Since I first read them in early 60’s, I have watched as many of his concepts have become reality. Orwell’s book was centered on the rise of Fascism in the 30’s, while Aldous was writing entirely about the future.

      3. Dr. Göran Sjöberg

        Frederica,

        What an amazing coincidence that a relative to the famous author appears here at Dr. Kendrick’s blog to comment my most recent reading about scary “worlds” a reading which also happened to be by coincidence.

        What strikes me is though that it doesn’t matter very much what any prominent representative from an intellectual “elite” in our society may see and put on paper if it does not materialise among, down to earth, common people.

        This struck me yesterday evening when I listen to a rather informal talk on GMO hold by a farmer in our local community. He had himself been rather successful in his mission against GMO among his fellow farmers. He pointed out that farmers hardly listen to any intellectual outsider. On the contrary such people tend to make them rather suspicious.

        In reading the very interesting book “The Soil Will Save Us” by Kristin Ohlson I found that she constantly return to this mistrust among farmers. In a case of my own I must tell that it took me about twenty years to have a farmer friend of mine to come and listen to my public talks about the corruption in medicine. When I now and then go and see him at his farm and at the same time meet farmers there he is always making a big fuss and laugh among his farmer friends of me being a “Professor” although today I am “just” a doctor.

        I guess farmers historically have had some very bad experiences of being fooled by our “kind” of people.

        This is perhaps why I believe that any profound change towards a less scary world must come from grass root movements but where “intellectuals” my help if we for whatever reason have such an inclination. With Schopenhauer I believe that there may be some exceptions from the general rule of pure selfishness even if such exceptions are rare and thus constantly give rise to suspicions about hidden agendas.

        If I didn’t believe in such exceptions I wouldn’t dwell here on Kendrick’s blog.

    1. David Bailey

      Colombo,

      My answer would be to use the internet, but only look at sites run by British doctors! Then take the answer that requires least medication/investigation – hopefully none!

      Remember that everyone dies eventually, so as you get older you should worry less and less – whatever happens can’t destroy the years you have already had!

      Reply
    2. Flyinthesky

      He’s not lying, he believes, this is in itself a dire situation but then they, TPTB, compound the problem by introducing financial incentives.
      We are led to believe that the doctor “knows” best. In the main they don’t “know” they accept.
      This is all well and good if it was presented as I think, it isn’t. The power is in the declaration of knowing.
      If your doctor expresses the thinking meme as opposed to the knowing meme he is disempowered by a factor of 10. It rarely happens, it’s a human nature thing. I have this power and I’m keeping it.
      There are some doctors, the M.K.s of this world, that consult, though it in my experience most like to direct.

      Reply
  39. Jennifer

    It certainly is scary, especially for us females….the message is hopefully getting through that women stand to gain nothing but problems by taking statins…..and along comes the HRT brigade once more.
    My GP wanted me to commence HRT well into my 60s, having never used such therapy in the past…..if they can’t get you one way….Big Pharma will get you another.
    So you women out there…….steer clear of the surgery……do your research if the menopause is proving troublesome, ( and it certainly can be unpleasant), but remember it is not an illness….competent health providers ought to advise you about safe and natural ways to cope with it, and I believe that that rarely includes the need for toxic medications.

    Reply
    1. PeggySue

      Oh Jennifer, it really is.

      Last year I went to the doctors feeling completely fine in myself but with a minor skin complaint. To cut an extremely long story short I’ve now got high blood pressure, and am taking minimum doses of two drugs. I still have the minor skin complaint but who cares – I’m scarred for life in other ways less superficial.

      Now, thanks to the menopause, I find myself not feeling very fine at all but the last thing I want to do is go near the surgery!

      Reply
      1. Jennifer

        PeggySue, I really feel for you.
        I, too, refrain from visiting the GP these days, which is a worry in itself, because some day there may be a justifiable reason to seek help.
        But as Columbo states above, what/who are we to believe?
        I posted my concern about HRT after listening to Woman’s Hour on BBC this morning….both my husband and I were disgusted at the responses given to Jennie Murray when she tried to get a decent reason for the change of direction( a reversal) that NICE has now taken.
        Where do we seek impartial advice? Who will treat us as individuals with complex needs? I thought the days of “the appendix in bed 38” had long gone….but apparently not. We are just all lumped together as “pre-menopausal” or “post- menopausal” or whatever category springs to mind for easy-peasy mass medication.
        P.s. And I am not having my flu jab for the 3rd year running….purely a personal statement….and already sick to the oxters of the repetitive texts and letters reminding me to pop along!

      2. David Bailey

        BP medicine is the only one I take (and have taken for about 15 years). Whether you decide to continue, or to stop is up to you, but I wouldn’t really worry about that too much.

        If you do decide to continue the BP treatment, I would opt to measure your BP at home. You will probably find it is lower than in the surgery because you won’t be tensed up.

        As many have said, it is probably best to stay out of the surgery unless you have a troublesome symptom.

        One of the biggest criticism of the current system is the constant nagging to get this or that checked – which can generate intense stress. I don’t accept any of the offers of tests, and I don’t have my cholesterol measured, since I stopped taking statins (a long story with a happy ending).

      3. Barry

        PeggySue & Jennifer,
        Off topic but since you are suffering.
        You may find What Your Doctor May Not Tell You about Menopause by John Lee M.D. of interest (ISBN 9780446691420). It’s a relatively old book (last reprint 2005) but full of useful information.
        Dr Lee covers HRT and the risks posed by using synthetic hormones versus natural and the problems associated with estrogen dominance, which may be aggravated by estrogen mimicking chemicals in the modern environment.
        Jennifer – congratulations on refusing the flu jab – another ineffective money spinner.

      4. PeggySue

        Thank you Barry. I’ll bear that one in mind. What I need to do is thoroughly understand what I really think about the whole thing, rather like I have done with my asthma and blood pressure.

        Unsurprisingly, with hrt in the headlines, there are a lot of very passionate arguments out there at the moment which go from one extreme to the other.

        Somewhere in the middle lies the right solution for me but now is probably not the best time to come to any rational conclusions.

        What I won’t be doing is discussing it with my GP any time soon!

      1. Jennie

        Off subject here but related to what Jennifer said about the flu jab.
        Husband age 82 fit as a flea, no medication at all walks miles everyday, eats well.
        Does he need his flu jab??

    2. mikecawdery

      Down load the NHS guideline on HRT (all 283 pages). Think of the questions you could ask your poor GP. But there is a quite useful summary.

      The old story – as Jennifer says – know yourself and the risks and benefits, both of which can be very rare.

      Reply
      1. PeggySue

        I did Mike, and to be honest, I wasn’t very impressed with any of it.

        There was one table that doctors are supposed to “discuss” with patients re. Stroke risk. An unbelievable 10 out of 16 boxes (including two complete columns) had “No data available”. Fat lot of good that is!
        I became slightly disenchanted at that point.

        I then made the mistake of reading the comments section in a certain paper – for a start there are a lot of horrid women out there who apparently sailed through the whole thing like a dream and think us sufferers must be obese, whining fuss-pots (I’m not obese).

        OR it’s a plot by the government to keep women working for longer in line with the ever increasing retirement age.

        So I posted here instead!

      2. mikecawdery

        PeggySue

        Yes and if you checked the NICE advice, NG23 as I remember – the 283 page effort was even more confusing. But then the NICE advice – if GPs read them all they would not have time to see any patients and would probably be so confused they would need serious medical attention.

      3. celia

        I’ve been on HRT for 20 years. Both the menopausal and post-menopausal types. My symptoms were absolutely unbearable, and though I’ve tried to come off several times I couldn’t function without. My solution now has been to cut the pills in half, and after some time in half again, so I am now taking a very minimal dose – and getting some hot flushes, but less often and less severe. I’ve stopped worrying about risks, and do not have a family history to give me concern. I suspect it’s a case of asking yourself “can I function without HRT?”

  40. Barry

    Göran,
    I recommend you follow up with Brave New World Revisited ISBN 9780099458234.
    In many ways we are already beyond the future that Orwell and Huxley envisioned.

    Reply
  41. Stephen T

    Jennifer, last year’s flu jab helped 3% of people. Of course we’re promised this year’s will be better. If you’re sick of texts and letters, I’d suggest telling your surgery not to contact you short of an emergency. They should only use your details with permission. That’s my plan when I get my annual request for a blood-pressure test.

    Reply
    1. Flyinthesky

      That would be my response to any “invitation” with menaces. Don’t call me, I’ll call you. There we are, NHS crisis resolved. All the surgeries are stuffed with people induced to think they may not be well. While the unwell can’t get an appointment.

      Reply
  42. Paul helman

    As the premis leading to the developement of this drug is flawed we can anticipate that absolute risk benefit will approach nil. The cost benefit ratio will be staggering and the drug will prove another monument in the over simplified but tempting model of atherogenesis that trails back to Virchow

    Reply
    1. Barry

      Paul,
      My bet is on negative benefit/cost ratio. I can’t think of a single positive effect (patient’s health perspective) from the prescribing of PCSK9 drugs but many adverse effects which will require treatment at additional cost. Will the adverse effects be dismissed as “It’s all in your head” by some doctors?

      PCSK9’s earlier research tab was NARC-1 (neural apoptosis-regulated convertase 1) which isn’t a name that inspires confidence. See also http://www.ncbi.nlm.nih.gov/pubmed/16893422.

      It’s reached the stage, as may be witnessed by the comments on this site, that many people now fear going to a doctor. In many ways that is a good thing as the fewer drugs one takes the better but there is also the risk that serious issues may remain undetected/treated until it is too late.
      This is all a direct result of the parasitic greed of drug companies, the lust for power, status and money by the bought academics/researchers plus their supporters in the political world. Those that form the current status quo refuse to see the elephant in the room.

      Reply
      1. mikecawdery

        Barry

        I loved the following from the abstract:

        Specific knockdown of zebrafish NARC-1/PCSK9 mRNA resulted in a general disorganization of cerebellar neurons and loss of hindbrain–midbrain boundaries, leading to embryonic death at 96 h after fertilization

        I have no intention of taking a drug that generally disorganizes cerebellar neurons with loss of hindbrain–midbrain boundaries. Someone will have explain that away.

    1. Jean Humphreys

      Sort of wish you hadn’t mentioned that! Took the stuff for a year or so and it sorted the flushes, but made me feel bad so gave up and endured them. Only after I stopped did find out how it is made. I find it hard to shake off the guilt even now.

      Reply
  43. Stephen T

    Jennie, if you see my last posting on the flu jab, you’ll see how ineffective it was last year. I think the benefits of a drug should be clear before we inflict them on our bodies. I said that to my chemist about statins and other drugs and he replied, “On that basis hardly anyone would take anything.” Exactly.

    I wouldn’t take the flu jab. When someone’s fit and well, why mess with success?

    Reply
  44. Spokey

    That does sound brazen. Isn’t FH diagnosed via genetics? Surely just lowering a threshold on blood lipoproteins for diagnostic purposes here is extremely unscientific?

    Reply
  45. Soul

    In America there has been a good amount of news recently concerning retail sales and how poorly retail stores are doing. It seems to be across the line with poor sales, from Walmart and JC Penny’s to more upscale stores such as Macy’s reporting dismal sales. It sounds like the much anticipated holiday season where many stores make most of their moneys will be slow this year.

    I can imagine much of the poor sales is coming from the much higher health insurance costs coming in for the new health care system we have. I know for me my health insurance costs have doubled in the last couple of years. I’ve seen many others with similar complaints. Despite low gas prices, which was predicted to improve retail sales with people having more discretionary money to spend, the opposite has turned out to be the case.

    Should be interesting to see how the PCSK9 inhibitors work into the system. If they are a big success with sales, and the costs are as prohibited as reported, should make for many more headaches for retailers.

    Reply
  46. Anna

    Regarding menopause, I’ve had a pretty tough time with it. The first year wasn’t so bad but I went through 2 years with hot flashes every 30 minutes around the clock. I finally went and got a compounding pharmacy and wholistic doctor to prescribe bioidentical hormones. They didn’t help, but it may be that the dose needed to be higher. The saliva test costed 100 dollars and was not covered by insurance, and the doctor was 90 minutes away. I don’t like coming more than every 6 months. So I didn’t have good followup. I have tried a number of over-the-counter remedies, with varying success. Unfortunately, I am prone to headaches. Amberen may or may not have helped, was expensive. Estroven seemed to be helping, but after taking it 2 or 3 weeks it started to give me headaches. It has black cohosh as an ingredient, and that sometimes gives headaches. Problems falling asleep are worse to me than the hot flashes. St. John’s Wort works like magic, but after taking it a month, it gave me headaches. Now after 6 years the hot flashes are down to maybe 2 at night and 3-5 during the day. I can live with that. Sleeping varies, but I seem to be doing better. But there are other things one can try than HRT, and most people probably don’t have tendency toward headache that I do. Also natural progesterone helps some women. Didn’t help me, but I think it is a good thing to do as per Dr. Lee’s books, to combat estrogen dominance and may help with sleep as well.

    Reply
    1. Barry

      Mike,
      Nowhere near it. It costs way too much and under delivers.
      Cost.
      Plenty here http://www.zerohedge.com/news/2015-11-15/meet-family-just-spent-half-its-annual-income-paying-obamacare to show how expensive it is and how it fails the lower income households in particular. Rampant profiteering by all involved.

      And what do you get (to add to the information you provided)?
      http://www.commonwealthfund.org/publications/fund-reports/2014/jun/mirror-mirror

      http://www.businessinsider.com/us-health-lags-the-developed-world-2013-1?IR=T

      Without a total collapse of the healthcare system it is difficult to see how this situation will ever be resolved so as to provide good healthcare at an affordable cost. Corruption is too embedded in American business and politics.

      Reply
  47. Lucy

    I guess you know Dr. Kendrick you are listed as a quack on some websites. Of course, I have been censored from a nutrition website because I told them there was no evidence that butter in moderation was bad for them. I also said that whole lipoprotein A theory is not proven. Nobody really knows what causes heart disease. I went to my doctor because I had a terrible ear infection. Believe me I tried not to go. The minute I got in the office, I was nagged and nageed: you need cholesterol test, you should be taking statins, you need to check your blood sugar (fasting blood sugar was one point above 100) you need a colonoscopy and a mammogram also a pap smear. I now have two non diseases Pre diabetes and hypercholesterolemia. I am normal weight with no family history of diabetes. I will not consent to most of these tests. There’s no proof that mammograms and early diagnosis extend life. I won’t take statins, I tried and they made me sick. My brother got liver damage form Statin and the doctor told me, well he probably had liver disease before he took drug. AS far as I know, there wasn’t anything wrong with him before he went in for a routine physical and received Lipitor. That’s when the liver problem started. His enzymes are off sometimes and sometimes normal. He quit the drug. BTW the American Heart Association is on radio here preaching about “bad” fats and it’s all being sponsored by the Canola Industry. There’s no proof that any fat(butter or lard) is bad, except Transfats are not good. I think Canola oil and vegetable oils are bad because they are not really food items and don’t exist in nature.

    Reply
    1. David Bailey

      Lucy,

      I arrived on this blog because of a very nasty reaction to Simvastatin, that started 3 years in – so I was luck to identify what the problem really was. I usually suggest newcomers read Malcolm’s book, “Doctoring Data” – but you seem to have already realised how corrupted medical science has become!

      You didn’t mention salt – but yes, that scare seems to be bogus too:

      http://www.scientificamerican.com/article.cfm?id=its-time-to-end-the-war-on-salt&print=true

      While I was on Simvastatin, I got a diagnosis of hypercholesterolemia, so I cut back sharply on sugary foods, which seemed to solve the problem. Statins also often raise blood sugar (how crazy is that!), so you might want to check if it was while you were taking statins that you got your bad reading.

      I have talked to so many people (in real life) who have had nasty side effects from statins, so I will never take these drugs whatever happens to me.

      Reply
    2. BobM

      If there are tests that are useful, I think they might be blood sugar and insulin (even better, a glucose tolerance test with insulin, but I haven’t been able to find a place that gives that). To the extent there is “high” “cholesterol” or “low” “good” “cholesterol”, these are probably markers for something else. (Although much evidence indicates “high” TC or LDL is actually good.) My opinion is, these are markers for insulin resistance or other insulin/glucagon errors. Those are more important than cholesterol by a long shot.

      Reply
    3. Sarah

      Hi Lucy, do you not rate nutritionists. I was thinking of going to one to see if they could offer something alternative to meds for blood pressure.

      Reply
  48. Barry

    Mike,
    “Someone will have explain that away.”

    Yes, and hopefully in a court, although not before a lot of people have suffered illness or been killed by PCSK9 inhibitors.

    Reply
  49. Stephen T

    I would appreciate people’s views on a new form of screening.

    I have just received a letter from the NHS with a leaflet entitled ‘Bowel scope screening’. Eveyone over the age of fifty-five will get this invitation some time after that birthday. The letter claims that the screening saves lives. What is good is that there is an explanation of the benefits and downsides. For every 300 tests 2 bowel cancers are detected and one life is ‘saved’ over ten years.

    A thin flexible tube with a tiny camera is inserted into the bowel in search of small growths called polyps. Carbon dioxide is pumped into the bowel to open it up to allow the nurse or doctor to see the polyps. These polyps do not usually cause problems but some might turn cancerous. If they’re found during the test, they’re removed and tested.

    Out of 300 people who have a test 285 will have a normal test. Because of abnormal polyps, another 14 will be offered a further test called a colonoscopy. 1 cancer will be found.

    A list of factors said to reduce the risk of bowel cancer are shown and are mostly sensible such as not smoking and being a healthy weight. However, it also includes, “eat less red meat”. I wonder how robust the science behind that statement?

    What I do like is the use of NNT to list the benefit and risks. This should be done with statins and other drugs. The leaflet admits that 1 in 5 potentially cancerous polyps won’t be detected. One person in 3,000 may have serious bleeding or, more rarely, the bowel can be torn. 20% of people said the procedure was at least partly painful and 3% described the pain as ‘severe’.

    Perhaps unwisely, I recently questioned the benefits of breast screening to a woman friend, mentioning the false positives, harmless cysts found and anxiety caused. The slightly frosty response I received was that if it saved one life it was worth it. Where do we draw the line with this? How much needless worry and anxiety equals one cancer prevented? I used to think this sort of screening was a good thing, but I’m now sceptical and I don’t think I’ll accept the invitation. I’d appreciate people’s thoughts.

    Reply
  50. MaryD

    Amazing co-incidence. I just heard on the car radio this very morning about a new injection to take LDL levels to new lows. I intended to email you to weigh in on the subject, then found your most recent blog is ahead of the game. Wow. I cannot believe these companies! Well, I can. Keep telling people the truth, Dr. Kendrick.

    Reply
  51. Susan J

    Dr K, this isn’t strictly relevant to your current blog post, so you might not want to publish it, but I thought people might be interested.

    “Statin Nation II: What Really Causes Heart Disease?”

    http://articles.mercola.com/sites/articles/archive/2015/11/21/statin-nation-2.aspx

    The above link gives access to the film for free up to 27th November 2015. And of course you are in it, so I’m surprised you haven’t drawn attention to it yourself! There may be better. more direct links that I didn’t find. 🙂
    —–
    Another article you may find interesting is this one :

    “The connection between the junior doctors’ contract and the American corporate takeover of the NHS”

    http://koshh.org/the-connection-between-the-junior-doctors-contract-and-the-american-corporate-takeover-of-the-nhs

    The article is written by a doctor from the Channel Islands.

    Reply
  52. Maureen Berry

    Well, Dr Kendrick, are you watching with interest the hearing of Prof / Dr Tim Noakes, accused by South African Dieticians of mal-practice? Another of my heroes, I do hope the hearing comes to the right conclusion.
    You Mavericks and Quacks need to be very careful!!
    Did you know that the patient forum of the NHS has published a warning about Familial Hypercholesterolaemia and how it is under diagnosed? It is sponsored, I presume by a drug company. I thought we didn’t allow direct to patient advertising in the UK!

    Reply
  53. Brian Wadsworth

    I have a question Malcolm.

    How many new drugs, in general, have emerged in the reasonably immediate past that have a positive benefit/adverse effects profile in your view? Is pharmaceutical industry research actually being productive in your view?

    I just wonder whether the development of new drugs has run its course as a technological wave so that all the fruit has been picked?

    Reply
    1. Stephen T

      Brian, if you review very recent blogs you’ll see that question answered. From memory, only about 5% of new drugs were regarded as a real advance and only 2% were a breakthrough. All that effort, intelligence and money wasted on so little. In the meantime we desperately need new antibiotics, but they’re not seen as big earners because we only take them occasionally and then for only five days.

      Reply
      1. annielaurie98524

        Don’t bet on it. You are better off not to depend on the pharmaceutical industry. Keep your immune system at its best, and keep abreast of updates in integrative medicine.

  54. Janet B.

    I have never posted here before.
    I am having the hardest time wrapping my head around the money factor. Not as far as Big Pharma is concerned but in connection with the Doctors and even more so the researchers involved . I received an email from FHfoundation.org today (not sure how they found me??). The publication was all about the study you have cited above. One of the researchers was as follows “It was a tremendous honor to welcome the godfather of the discovery of FH to our 2015 Summit. At 90 years young, Dr. Avedis Khachadurian remains the leader in our field and continues to engage students, educators, clinicians, and patients from his post as Professor Emeritus at Rutgers University.” and two others (Brown and Goldstein) used his work re: fibroblasts which culminated in a Nobel Prize. These people have dedicated their lives to this research. That being said how does it get there from these seemingly dedicated researchers work to the overt drug pushing for billions. Is the research tainted ? Does it get so twisted and manipulated by Big Pharma for their own corporate AND personal gain. I am a “borderline” FH patient, have had an MI and a DE stent in the LAD. I have researched and read until my head spins . I am scared about my future BECAUSE I am confused about statins and these new drugs which I can’t afford anyway. But, I am Grandma to a 4 yr old precious girl and I am determined to try to make sense of all this to watch her grow a little longer.

    Even with inability to understand the money trail I have a gut feeling to believe in what you write about. Your dedication to this is above and beyond and in no way self serving. When it is your one life it is difficult to question your Doctor and say basically I don’t agree because after all I am just a Grandma …

    Perhaps the deadlock between true medicine and profitable medicine will merge for the common good when our US Congress does so :). Thank You for all you do !!

    Reply
  55. Frederica Huxley

    Inconsequential (?) little news item in The Times this morning; “A genetic condition that causes dangerously high cholesterol could be putting 250,000 people at risk of an early heart attack. The British Heart Foundation said that twice as many people may be living with the gene for familial hypercholesterolemia than previously thought. Only 20,000 people are being treated in specialist clinics. The charity said that if all those with the gene were identified, up to 25,000 early deaths could be avoided.”

    Reply
    1. annielaurie98524

      Ah, and where is their citation for that figure? And what of all the heart attack victims that have cholesterol in the “normal” range? I am sure we could (increase Big Pharma’s profits) “save” those folks, too, if we just lowered the “normal” range yet again.

      Reply
  56. smartersig

    This is really interesting because I was at the HeartUK conference around September 2015 where an attempt was made to shout me down for suggesting that Lp(a) could be effected by diet and in particular Vit C. I am digressing however as the point I wanted to make, and I got this impression before I knew anything about this new drug or this blog entry, was that the vibe at the conference was a push to redefine the limits that signal Hypocholestolemia (spelling ?). I feel rather vindicated because at the conference it was not said as such but I certainly said to people and maybe on one or two blogs, that the next step to widen the net will be to lower the definition levels. I thought this was just to get more people on Statins and a response to the anti statin push but now I can see what was coming over the horizon. As you say you could not make this up. By the way if you want a good laugh at the blind leading the blind then attend the HeartUK conference.

    Reply
  57. SmilinSteve

    The association between LDL levels and premature CAD is strong and using this “surrogate marker” is justifiable. Outcome data for PCSK9 Inhibitors would be nice, but people will die prematurely waiting for the data.

    Studies questioning the use of a surrogate marker (LDL level, CIMT, etc) were done on populations with already low LDL numbers (70 mg/dl or so), where second drugs like Zetia or Niacin did not show additional benefit over a statin alone.

    The FH population is a much different case. these patients can not achieve LDL levels below 100 or even 130 using statin therapy and would most definitely benefit from PCSK9 inhibitors which are the only known way to get these people to what is considered a normal healthy lipid profile.

    In short, the need for lower LDL levels in the FH population is clear, and outcome data, when it arrives, will certainly show a benefit of these new drugs.

    The cost is another matter, but if you were part of the FH population, like I am, and doing everything possible to control lipids, only to see that year after year your cardiovascular health declines as the disease progresses, then you would see as clearly as I do that not approving these drugs would be a crime.

    Reply
    1. Dr. Malcolm Kendrick Post author

      Outcome data for any medication is not ‘nice’ it is essential. Recent trials have shown dramatic decrease in LDL levels with no effect on CVD.

      ‘Cleveland Clinic researchers studying evacetrapib have shown that despite reducing levels of low-density lipoprotein (LDL, or “bad” cholesterol) by 37 percent and raising levels of high-density lipoprotein (HDL, or “good” cholesterol) by 130 percent, the drug failed to reduce rates of major cardiovascular events, including heart attack, stroke, angina or cardiovascular death.
      The phase 3, multi-center clinical trial was discontinued in October 2015, on the recommendation of the independent Data Monitoring Committee after preliminary data suggested the study would not meet its primary endpoint of a reduction in major cardiovascular events. The research is being presented at the American College of Cardiology’s 65th Annual Scientific Session
      “Here we have a paradox. The drug more than doubled HDL and lowered LDL levels by as much as many statins, but had no effect on cardiac events,” said Steve Nissen, M.D., chairman of Cardiovascular Medicine at Cleveland Clinic. “These findings illustrate the importance of performing large, high-quality outcome trials. Just looking at the effects a therapy has on cholesterol levels doesn’t always translate into clinical benefits.”

      Reply
      1. smilinsteve

        You make a good point about evacetrapib, but I will point out that the drug, although showing no cardiovascular benefit in the Accelerate study, also did no harm and had borderline significant benefit for all cause mortality (.06). For people who have the death sentence of FH, approving a drug that has a “good chance” of working, and a “small chance” of doing harm, based on initial studies, makes sense, and people should have the option to take that chance rather than resign themselves to their current rate of disease progression.

    2. smartersig

      Meanwhile I can guarantee that all bodies attached to Pharma (insert medical profession) will be doing there best in the next few years to lower thresholds for FH. I saw evidence of this at the HeartUK conference last year.

      Reply
      1. smilinsteve

        Money will be the driving factor. Although the manufacturers of PCSK9 inhibitors will want to increase the market, insurance companies want just the opposite, due to the high cost. No matter where you set the threshold for FH, the real question will be whether or not you can adequately manage lipid levels with statins or other established means.

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