A tale of mice and men

(PCSK9 and diabetes)

I look into my crystal ball and I see…. I see another wave of diabetes. Yes, the great Nostrokendrickos has spoken. Why do I predict this? Well, I see those given PCSK 9 inhibitors developing diabetes. I see the pharmaceutical companies telling us that this was completely unexpected, a paradox, and not clinically relevant anyway. Hold on…. no the vision is fading….it is gone.

Being an old fashioned type of person I have this strange belief that the body does not produce complex enzymes for a laugh. It takes a lot of energy and resources to make enzymes, or any another form of highly structured protein. If there is no need for them, and what they do, the body sighs with relief and stops making them. Then, over the years, evolution gets rid of the enzyme altogether. It’s kind of how evolution works.

So when we do have an enzyme Proprotein convertase subtilisin/kexin type 9 (PCSK9) I think: What is its purpose? Can it simply be there by mistake? To be frank, I am not entirely sure what the purpose of this enzyme is, but I now know that if you do not have it, bad things can happen. Here is a study which looked at what happens to mice with no PCSK9:

‘Proprotein convertase subtilisin/kexin type 9 (PCSK9), a liver-secreted plasma enzyme, restricts hepatic uptake of low-density lipoprotein (LDL) cholesterol by promoting the degradation of LDL receptors (LDLR). PCSK9 and LDLR are also expressed in insulin-producing pancreatic islet b-cells, possibly affecting the function of these cells. Here we show that, compared to control mice, PCSK9-null male mice over 4 months of age carried more LDLR and less insulin in their pancreas; they were hypoinsulinemic, hyperglycemic and glucose-intolerant; their islets exhibited signs of malformation, apoptosis and inflammation. Collectively, these observations suggest that PCSK9 may be necessary for the normal function of pancreatic islets1.’

Sorry, I realise that the language is a bit technical, so here is a quick interpretation.

  • PCSK9 is an enzyme that degrades/destroys LDL receptors, so cells cannot absorb so much LDL (a.k.a. ‘bad’ cholesterol)
  • Without PCSK9, beta-cells in the pancreas (where insulin is made) absorb too much LDL
  • These LDL ‘overfilled’ beta cells were found to be malformed, dying (apoptosis) and inflamed
  • Mice without PCSK9 which had these ‘overfilled’ beta-cells were also glucose intolerant, did not produce enough insulin and were hyperglycaemic a.k.a. there were diabetic

That was mice, what of men? (And, of course women). Well, if we look at people with familial hypercholesterolemia (FH), they have a lack of LDL receptors, or the receptors don’t work so well due to malformations, or both. Therefore, you get less LDL inside cells, including beta-cells. Therefore:

‘In the cross-sectional analysis from the Netherlands, patients with familial hypercholesterolemia were found to have a 51% lower odds of having type 2 diabetes compared with relatives without the cholesterol disorder, and diabetes prevalence varied by gene mutation type…. Hovingh and colleagues hypothesized that this reduced risk occurs because pancreatic beta cells in people with the condition have decreased cholesterol uptake and improved function and survival2.’

Hovingh was almost certainly right.

Now some people will, no doubt, grab hold of this research to tell us that ‘As we told you all along LDL is dangerous and damaging, it even causes diabetes by harming beta-cells.’ I am sort of waiting for an ‘expert’ to tell us this. Maybe they already have. At which point I shall approach them from behind, then hit them repeatedly with a large wet kipper. I shall then announce, with great satisfaction…

‘No, you idiot, what this shows us is that excess LDL inside cells is damaging and dangerous, but that has absolutely nothing whatsoever to do with having a high LDL level in the bloodstream…..you idiot.’

Anyway, adding this information together with the study on mice, it seems that the basic function of PCSK9 may simply be to ensure that cells do not absorb too much LDL from the bloodstream, thus protecting them from: malformation, inflammation and death. It certainly seems to be true of beta-cells in the pancreas. Is it true for all other cells – who knows, but it is a bit worrying is it not?

What is certainly true is that PCSK9 inhibitors will almost certainly increase the risk of diabetes, to an even greater extent than statins. This seems entirely predictable; in fact I predict it now. I also predict that the increased risk of diabetes will take years to emerge. This will be for various reasons that I would like to go into, but fear libel suits.

However, when this adverse effect does eventually emerge I know that it will greeted with astonishment and surprise by the ‘experts’ and, at least in public, by the pharmaceutical companies marketing these drugs. Although I am perfectly certain that they know all about this research… they always do. They ain’t stupid.

The great Nostrokendrickos has spoken. Put this article in a time capsule, to be opened when PCSK9 inhibitors are found to cause diabetes.

References:

1: Majambu Mbikay, Francine Sirois, Janice Mayne, Gen-Sheng Wang, Andrew Chen, Thilina Dewpur, Annik Prat, Nabil G. Seidah, Michel Chretien  Fraser W. Scott: ‘PCSK9-deficient mice exhibit impaired glucose tolerance and pancreatic islet abnormalities.’ FEBS Letters 584 (2010) 701–706

2: http://www.medpagetoday.com/Cardiology/Diabetes/50429

P.S. I wonder what other research they are aware of? I think I might go and find out.

83 thoughts on “A tale of mice and men

  1. Fergus

    With your analysis of things, it is entirely possible that these PESKY 9 inhibitors will cause more diabetes than statins did. As you predict the response will be the same. “What’s a little diabetes between friends when you can have a cholestorol reading of 2.7?? “

    Reply
  2. Ellien

    Dr. Kendrick, you’ve done it again. You have the ability to ask the right question, at the right time, and the integrity and honesty to report it. No, it is not just the ability to ask that question, but to care enough to think the thought, and then publicise it. I think it is what good medicine, like good science, is made of, so it continues to astonish me that the medical elite, who dictate what the medical masses must do, are so beholden to the drug companies. I think this is a political issue, one which those who make the decisions at the top, about how taxpayers’ money is spent within the NHS, should be made aware of. The dangers, as you describe them, seem obvious, even to a layperson like me.

    Reply
  3. Lynne

    Isn’t it strange how nature through the human body makes all these wonderfully complicated substances to keep the body functioning on such a fine scale and then along we come and decide that nature has got it wrong. Goodness knows how the human race has survived thus far. At my last blood test my cholesterol was 7.4 (about 5 years ago, I am very healthy, how can that be?) and there it will stay if I have anything to do with it!

    Reply
    1. SJ

      Plus all these indigenous peoples around the world – if Big Pharma was to be believed, they should all be extinct now, especially the Inuit, and other Arctic tribes, their diet should’ve seen them all dead from atherosclerosis long ago!

      How DO these tribes manage without the ‘marvels’ of modern medicine, eh…?

      Reply
      1. Mark Waters

        SJ
        You ask How do indigenous people manage without Modern Medicine….see Western Price in his book ,”Nutrition and Physical Degeneration”,for an overview of what happens to traditional people when they encounter modern food.Unfortunately there is some research still to do in the Price Pottenger foundation archives as I understand that Western Price did measure the carbohydrate content of the food eaten but the details are not in the book .

  4. Jackie Kay

    I SO wish you were my Dr. You’re so ‘on the ball’ and so funny with it to. I love reading your posts.

    Thank you 😀

    Kind regards.

    Jackie Kay

    >

    Reply
    1. mikecawdery

      Thanks for the link. Interesting. I wonder How Dr Kendrick will interpret this. The final sentence of the abstract
      Together, these results show that PCSK9 expression is regulated by nutritional status and insulinemia.
      suggests that this new drug will disrupt normal metabolism with what unforseen consequences

      Reply
  5. Sue Richardson

    Wow, you’re on a roll here Dr K! Another informative article. How on earth do you find the time? I hope I’m around when the kipper-bashing happens – and I hope it makes the news….”Eminent Doctor from Scotland, Sir Malcolm Kendrick was applauded today by the Entire Medical Establishment when, with a large kipper he…..” No, I can’t see it somehow. Still it was hilarious reading, and I really would love to see it happen.

    Reply
  6. Flyinthesky

    I’m tending to think that so long as the link doesn’t become universal and incontrovertible it will be played as tenuous at best. What it does present however is further opportunity for lifetime medication.
    The government remains wedded to the hypothesis that the reduction in cholesterol levels at whatever cost reduces their overall liability. Make no bones the government motivation is cost not individual well being.
    Until the government takes its’ brief from untainted scientists, care of consensus science scarce as hens teeth, the situation will remain ongoing and expanding.

    Reply
  7. David Bailey

    Wow – you are certainly very active after your holiday!

    One slight puzzle is that in the case of people taking statins, where less cholesterol is made, so there is less in the blood stream, and presumably less to clog the beta cells, you might have thought this would operate against diabetes. Are you saying that statins work in another way to cause diabetes (I got high blood glucose while I was on statins, so it has to be true!) and the two effects don’t cancel each other out?

    At a more practical level, couldn’t you write a theoretical paper in the BMJ on this subject?

    Reply
    1. Kevin O'Connell

      I forget the precise details, but the gist is: statins block the mevalonate pathway, cells respond by increasing (a lot) LDL receptors, thus lots of LDL is received into the cells (that’s why there’s less in the serum). All seems to fit very well with the thrust of this post.

      Reply
      1. David Bailey

        Thanks Kevin,

        However, that explanation only seems to work if you assume that the increase of LDL receptors over-compensates for the drop in the amount of LDL available in the blood stream! A good feedback loop wouldn’t do that.

  8. Robin

    Thanks dr. K … I very much appreciate your writings and your book Doctoring Data. Keep up with the good work !

    Robin
    Netherlands

    Reply
  9. maryl@2015

    Dr. Kendrick, I was wondering when we were going to hear from a real expert…or a couple of them at that. Brilliant and oh so true. No wonder these are so much more expensive…they know that it will take a long time for the diabetes cases to develop…and by then, they will blame the diabetes on something besides the Sons of Statins. But, they will never, ever blame themselves.

    Reply
  10. dearieme

    But what then?

    (i) New anti-diabetes drugs launched?

    OR

    (ii) Diabetes redefined so that the problem is conjured away?

    Let’s see you predict that, oh wise one.

    Reply
  11. Kay

    The drug companies’ announcement:
    “Look, world, we’ve done this heroic research and created this slightly obscenely costly drug that REALLY lowers cholesterol.”

    What they hope you’ll hear:
    “There’s this new wonder drug that REALLY lowers my risks of dying of heart disease.”

    What they hope you’ll believe:
    “There’s this new wonder drug that REALLY lowers my risks of dying.”

    What they hope won’t occur to you:
    “Everybody’s got to die of something, and there are a lot of things that people die of that are a lot less fun than a heart attack.”

    Reply
  12. Joan Flack

    Ang – I’ve read this twice and I still don’t really understand it!

    See you tomorrow sweetie.

    Love Jxxx

    >

    Reply
  13. Dr. Göran Sjöberg

    Thank you for bringing some logic into this medical mess.

    I now just wonder about the poisoning of the beta-cells with fat, lipopathology, as I learnt from professor Unger’s lecture about diabetes, causing the death of these cells. As far as I understand (or misunderstand) all the lipoproteins in the blood stream ferry fat as triglycerides together with some cholesterol back and forth from the liver, starting as VLDL and then docking to cells and dump some fat and cholesterol where such molecules may be needed in our bodies and these VLDL ferries finally ending up as ’empty’ LDL as ‘scrap’ (like beer cans) to be cleansed out by the liver.

    This is not easy for an ‘outsider’ like me to grasp in its complexity.

    Still, as a natural science researcher, I believe there must always be some basic logic bringing the overall map out and where we then can place the minor details in a consistent way, as you now have done for me.

    Reply
    1. Dr. Malcolm Kendrick Post author

      Dont think of diabetes as a simple insulin/sugar issues. There is far more going on, and the impact of fatty acids, visceral fat, glucagaon and many other factors has to be considered. My own view (having looked at this for many years) is that we have been mesmerized by blood sugar levels and the impact of insulin on blood sugar. This has blocked thinking.

      Reply
      1. Sue Richardson

        Could you explain what you mean about being mesmerised by blood sugar levels? These measurements are the B-All and End-All as far as whether or not you are diagnosed as pre diabetic or insulin resistant – at least as far as GPs and Diabetic Nurses are concerned. How do ordinary mortals sort it all out? We could all be worrying about nothing, or else not worrying when we should be.

      2. George Henderson

        The blood sugar is an immediate phenomenon, but unless you have DKA it won’t kill you quickly. HbA1c is longer-term but hemoglobin is relatively quickly replaced. The ceramides that pile up in the beta-cells because they are taking in too much fat in a high-sugar environment are what kills them off. The sugar or fat in your blood is a very poor indicator of the sugar and fat in your cells; with regard to cholesterol, for example, there are two pools, the cellular cholesterol and the cholesterol floating in the blood in lipoprotein particles, and the relation between them varies depending on what factor is creating the gradient. For example, high expression of LDL receptors means more cholesterol in cells expressing these (such as liver), less in the blood, and maybe less in other cells such as those in the brain. So serum cholesterol is simply not an accurate guide to the whole-body cholesterol level and a poor clue to the availability of cholesterol to any cell requiring it or disease process affected by it..

      3. Pat

        I consider myself to be severely medically challenged but find all of this fascinating. It helps to understand what is going on inside the body so that we can appreciate the result of an intervention like say, a change of diet. I have had adverse side effects from prescribed drugs in the past and have reported them, been pooh poohed and humiliated. Every one of the adverse side effects I have experienced now appear on medical web sites as “approved” acknowledged side effects today. My hackles rise when I am told adverse side effects are very rare. As a result I am very wary of drugs. I prefer to understand what is going on inside me and manage things myself if I possibly can.

        At a guess everyone has concentrated on (or been mesmerized by) insulin and blood sugar because it is the easiest thing to do and and the blood sugar changes (which only say something is going wrong inside but not what ) can be measured approximately. Maybe other interactions are not understood and or cannot be measured easily? Probably more complicated than that – money for example may come first.

        I would like to be able to find out exactly what is going wrong inside me (well it would be useful).

        I have no right to ask this Dr K but I would be very grateful if you could some time in future give us more on the other things going on like the interaction between insulin and glucagon, cortisol, visceral fats, fatty acids etc. Obviously we respect you have your own constraints. Maybe there is a good source somewhere? If so it wont be in plain English! You are very good at explaining things to us, being extremely patient when you are exasperated and not patronizing us. I hope you get something from us in return.

        Incidentally for those with diabetes Appendix C of Dr Bernstein’s book Diabetes Solution gives a 9 page list of drugs which can affect blood sugar levels. Dr B says this may be incomplete and is only intended as an educational aid and talk to your doctor!

  14. imnoclue

    What we really need is for everyone to be on a statin PCKS9 inhibitor cocktail. Think of how much of the new diabetes drugs they could sell.

    Reply
  15. António Heitor Reis

    Brilliant!
    Yes, I bet that in the near future we will see that the prophecy of the great Nostrokendrickos is fully verified!! Dr Kendrick has put forward an idea that is reasonable for any intelligent person who reasons in the context of the results of biomedical research, but without the thought blocked by old paradigms that are currently unsustainable.

    Reply
    1. mikecawdery

      Thanks – a useful addition to my collection on PCSK-9 inhibitors. though a $1,000 a treatment???????

      Reply
  16. med41

    Great post! M

    Marshall E. Deutsch 41 Concord Road Sudbury, MA 01776-2328 USA Tel: 1-978-443-5837 Fax: 1-978-443-8689

    Reply
  17. LeonRover

    A careless placing of a capital by a prestidigitator would turn NostroKendrickos into NostrokeNdrickos.

    Reply
    1. Dr. Malcolm Kendrick Post author

      Indeed. As a general comment, apologies to people who think their comments have been dismissed. I am trying to keep an eye on, at times, hundreds a day. Some get missed. I try to ensure not, but it is tricky.

      Reply
  18. marilynmann

    I was at the FDA advisory committee meetings on alirocumab and evolocumab in June and this potential diabetes issue was discussed by the committee and is also discussed extensively by the FDA reviewers. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM449865.pdf
    I also discussed it on my blog. https://marilynmann.wordpress.com/2015/05/31/do-pcsk9-inhibitors-affect-diabetes-risk/

    Reply
    1. David Bailey

      Marilyn,

      I notice that at the end of your blog you write:
      “I should note that even if PCSK9 inhibitors do increase blood glucose and the risk of developing diabetes, they would still be very worthwhile for patients who are at significant risk of heart attack and stroke, if they are shown to be effective and have acceptable safety.”

      I wonder how you can defend that. I mean statins do a pretty good job of lowering cholesterol/LDL, but as I understand it, the NHS itself accepts that their NNT is 77 even in those at serious risk of a heart attack! I.e. drastic lowering of cholesterol/LDL doesn’t make much practical difference.

      As I am sure you realise, this is exactly what Dr Kendrick is arguing, and it would be interesting to see a debate on this subject. Is it suggested that statins do not lower cholesterol enough to be very useful?

      Reply
      1. marilynmann

        David,

        When I wrote that I was thinking more of high risk people such as patients who have acute coronary syndrome, who (as you know) are at high risk of recurrent cardiovascular events and mortality. Also, with the outcomes trials not completed yet, we really do not know what the benefits and risks of the PCSK9 inhibitors will be, so it is not possible to say in detail in which groups the benefits will outweigh the risks.
        Since you mention primary prevention I will just say that there is no right answer and people have different preferences as to whether they want to take a pill every day to prevent a possible stroke or heart attacks, and people have different baseline risks as well. I am a strong believer in shared decision making and I believe everyone should make their own decision.
        W/r/t the PCSK9 inhibitors, they will be quite expensive so the insurance companies (in the U.S) or NHS (in the UK) will be putting limits on who can take them. They will not be as extensively prescribed as statins.
        Marilyn

      2. David Bailey

        Marylyn,

        Isn’t the NNT=77 the number for high risk patients?

        I mean what I am trying to get at, is that we surely already have data on the effect of a fairly substantial reduction in cholesterol/LDL (as supplied by statins), and it doesn’t look very impressive even for high risk patients – so is it likely that PCSK9 inhibitors will fare much better.

        Put another way, Dr Kendrick’s point is that there isn’t much evidence that blood cholesterol is dangerous in the first place. Here for example is a summary of various studies of overall mortality as a function of blood cholesterol level:

        http://vernerwheelock.com/?p=838

        Based on that data, why would anyone want to reduce their cholesterol level?

      3. Dr. Malcolm Kendrick Post author

        The wheelock blog is very good. I knew all the studies he mentions, but he brings them all together very nicely. I recommend it – for anyone still labouring under the delusion that a raised cholesterol level is harmful. The reality is that it is beneficial.

      4. David Bailey

        Marilyn,

        You are on the FDA advisory committee – and so presumably have the whole subject of the relationship between cholesterol and mortality at your fingertips. Since you took time to participate in this debate, wouldn’t it make sense to explain exactly why it is appropriate to ignore that long list of evidence from actual studies that high cholesterol does not shorten life (I will repeat my link):

        http://vernerwheelock.com/?p=838

        I am not a medical doctor – just someone who got burned by statins – and what really amazes me is that those supporting the orthodox view regarding saturated fats/cholesterol/statins seem hugely reluctant to debate the facts – even though (I assume) few if any of those studies results are in contention.

      5. marilynmann

        David
        First, I am on vacation at a location with a lousy internet connection. Second, I have debated members and sympathizers of THINCS many times before, and I’m just tired of it, I don’t think it’s a good use of my time. In any case, I’ve already put my time in with that type of debate. As you may have read on my blog, members of my family have FH; my husband’s grandfather had a fatal heart attack at age 35 due to FH; his uncle had a fatal heart attack at age 40; his mother had her first heart attack at age 58. I would like my hus band and daughter to avoid early morbidity and mortality due to FH. Notice I am not advocating that everyone take a statin — neither am I telling people not to take one — each person can make their own choice on that. Statins can have side effects, I certainly agree with that. Good luck. I wish you good health.

        Marilyn

      6. marilynmann

        Forgot to say — I was not on the FDA advisory committee — I was just there as a member of the audience. FDA advisory committee meetings are open to the public. Marilyn

      7. David Bailey

        Marilyn,

        Thanks for that clarification – sorry I had thought you were actually on the advisory committee!

        More generally, I do wish SOMEONE responsible for the orthodox position on these issues would debate with those who disagree – like Dr. Kendrick – based on the results of the actual studies of health outcomes – such as those I linked to.

        I myself tried to write to Sir Rory Collins about his claim that statins had few side effects! I never got a reply of any sort, even after Dr Kendrick kindly copied my email into one of his posts on this blog!

        I realise that the time of such men is limited, but I have never seen any ‘conventional’ answer to the evidence from a whole range of studies that raised levels cholesterol (not those with FH) do not increase overall mortality – which is surely what is important.

        I was treated with statins as a precaution, and you can read one account of my experience here:

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

        Because the symptoms took 3 years to emerge, I consider myself lucky that my doctor and I realised the cause of my problem before it was too late (as you can read, I checked by starting and stopping the statin several times). Here are many more accounts of the misery this drug has caused:

        http://www.askapatient.com/viewrating.asp?drug=19766&name=ZOCOR

        When we are told that statin side effects are rare, I do see red, because I came across a number of people who had suffered similar symptoms just by chatting with people my age! Statistically that can’t happen with a genuinely rare side effect. Tragically, there are also people who never fully recover from this treatment.

        However, my original challenge to you remains (after your holiday is over!), because as I understand it, the number of high risk patients that need to be treated with a statin for one to have an improved outcome (the NNT) is officially estimated as 77! On the basis of that evidence, is it ever reasonable to treat someone with these drugs?

    2. mikecawdery

      What is the actual number of deaths saved per year per 1000 treated. In the case of the HPS (supposedly post-MI or serious risk) it was 3/1000 p.a. In other words 997 were treated pa without benefit – a probability of 0.997, or, rounded to two decimal places 1.00 ; in short near certainty of no benefit.

      Reply
  19. Robert

    Hey, Dr. Kendrick, we have metformin, so it doesn’t matter if PCSK9 inhibitors cause diabetes! No problemo, we’ve covered all the bases.

    It’ll reach a point where newborns come with a leaflet with recommended medications for each decade, from 0 to 80, which is the optimal human life span for the drug business.
    Every week of a person’s life they will receive a shot with their medications to “extend” their life until the next week. I’m sure some people will not get five minutes late to the doctor because of a car jam, and they will start to get anxious and some even die because of fear.
    Eighty years times fifty two weeks, yields 4160 shots. Such a great business idea. Then people will say “Hey, we have to help those poor Tuareg guys, they don’t get shots every monday. For science’s sake, they’re so poor they don’t even have a Monday!”

    Reply
    1. Dr. Malcolm Kendrick Post author

      I am not sure, hepatocytes are pretty good at dealing with excess stuff. They will probably just recycle it and send out more VLDL, to become LDL to be re-absorbed into the liver. PCSK9 inhbitors could, therefore, reduce the risk of fatty liver? Although I find it hard to believe that drugs can make a healthy body work better.

      Reply
  20. Ari

    Diabetes (T2) medication is targeting only symptoms and even worsens health, such as the functioning of endothelium, stiffening of the arteries and retaining salt in kidneys, thus increasing blood pressure and distorting lipid metabolism (raising triglyserides, lowering HDL), increasing atherosclerosis – excess insulin does all this. And what causes excess insulin – blood pressure- and statin medication and excess carbohydrates and proteins – not fat. Read all about it in this article and don’t miss the lengthy article (16 pages) of Dr. Stout in Diabetes Care from 1990. The only reason this information has not affected dietary recommendations and diabetes care, I believe, is the appearance of statin medication in those days. The information, that Drs Kraft and Stout shared, wouldn’t have brought any money in the coffers of Big Pharma. Quite the opposite.
    http://www.thefatemperor.com/blog/2015/7/26/insulin-diabetes-rootcause-dr-kraft-excerpt-and-dr-stouts-ouevre-

    Reply
  21. mikecawdery

    Prog Cardiovasc Dis. 2015 May 1. pii: S0033-0620(15)00029-8. doi: 10.1016/j.pcad.2015.04.004. [Epub ahead of print]

    Excerpts
    In clinical trials proprotein convertase subtilisin/kexin type 9,( PCSK9) inhibition using monoclonal antibodies has demonstrated robust LDL-C lowering efficacy of 50% to 65% and a favourable safety profile.

    Some comments:

    If you look at the numbers that really count, it gets even worse for these drugs.

    The meds are supposed to save lives specifically by cutting the risk of heart problems and death from heart problems. But the study finds NO significant difference in the risk of death from heart problems.

    But patents are expiring, so Big Pharma is scrambling to cook up an expensive new replacement — a $1,000-a-month injectable drug that’s racing toward approval right now.

    Reply
  22. Joan

    There is a post on Facebook, a health care site, where the person’s doctor wanted them to apply for injectables for lowering cholesterol. Turned out to be Praluent. This, despite this person’s cholesterol being within normal limits on statins. Involved a “no cost” appointment to fill out paperwork, income statement, and discounted pricing for a certain period of time. So it starts! Only for very high risk people, really. Think it was going to be about $1200 a month. Someone estimated $2 an hour for this medication! Are people going to bankrupt themselves for this, like they are doing with chemo drugs here in U.S.? Or, are our health insurance premiums going to go even higher so everyone on statins can now be on these agents? With the diabetes risk being so well explained by Dr. Kendrick and no evidence for decreased mortality from heart attacks and strokes, the madness begins. It seems people will grasp at any straw, however misguided, that may make them live longer, no matter the cost.

    Reply
    1. Kay

      “. . . the madness begins.” There’s no other way to express this. I didn’t know this stuff was even available yet.

      Reply
    2. Stephen

      Well said, Joan.

      I wonder if making this drug expensive won’t make people think it’s somehow special and exclusive therefore adding to its appeal.

      Reply
  23. maryl@2015

    I guess it is a little off topic, but then again…not so. My mother died Saturday morning probably very early. She was given statins in her early 70’s. She had no heart or vascular disease. Her angiograms were “clean” meaning she had nothing that a 70 something year old woman in excellent health would probably have. She was first placed on Baycol. I recall distinctly how much she changed cognitively. She was moody, forgetful, combative beyond normal and the list goes on. She suffered so many health problems after statins, that I could not believe how much she aged in such a short period. She was on Simvastatin for 12 years. She was diagnosed with dementia, Alzheimers, and Parkinson’s. Hell they don’t even know what she had. She could not walk long distances anymore, had to have a pacemaker, and from there went downhill. When she was finally recommended for hospice care, she was delusional, hallucinating and was on so many medications, she was in a terrible state of withdrawal from the 23 medications they sent her home with. What was supposed to be a brief stay in a skilled nursing unit following a hip fracture and surgery, turned into a three month decline into oblivion. Seeing a person die like this is torture for the victim and his or her family. Since she could hardly swallow any longer, they took her off all these “poisons” and only gave her palliative care for pain and relentless episodes of what appeared to me to be seizures. She looked like she was in detox from heroine. It was heartbreaking. No one would tell me anything. Oh, they did not know…it could be anything, they said. Yes, but I know and I just hope that anyone here who has a parent on statins will read this and realize that this is no way to treat a lady. I will miss her so much. I miss the fun loving, affectionate, determined person who raised me. She died in a sense a long time ago. Her poor little body just could not take any more abuse. I hate those statins…I really do.

    Reply
    1. Dr. Göran Sjöberg

      So heartbreaking to read about how the medical ‘care’ system mistreated your mother. Myself, my wife and many others I know have experienced the same thing with their beloved ones although here in Sweden so I guess the ‘system’ is international.

      I just wonder how the physicians involved are thinking when they are prescribing all this medical madness. Do they think at all? I don’t think they are inhuman. Or what is it all about? Or is there an actual intention from the medical staff to turn elderly people into zombies?

      Funny society we are living in!

      Reply
      1. robert

        Maybe not on purpose, but it happens.

        One medication is prescribed and comes with side effects, which needs yet another pill. As people get older this goes on and on. One prescription turns into 2, then 3, 4, 5… It might even happen that prescription #1 is not needed anymore (e.g. through change of diet), but the cascade of side effects & pills is self-sustaining. And once you get to 10s or more different medications per day, nobody really knows about possible interactions. People just “get old”…

        When that happens, there is the choice of adding yet another potion to “fix” the n-th side effect – or to go the other way: test if removing one or another substance results in an improvement of overall well-being.

        Unfortunately I haven’t yet met a medical doctor that goes that way. Neither have I met one that is proactively pushing the diet / nutrition route. One Endocrinologist even told me that “diet has nothing to do with anything” – he was distinctly very not-slim and quite lacking in social skills.

        The problem runs very deep.

      2. maryl@2015

        Oh, the statinators have not heard the last from me. I guarantee you that I will hold up her story and the horrid condition she was in at the time of death as the real face of statin “intolerance.” We have spent an incredible amount of hard earned money to assassinate my mom. They threw in the torture just for sport. Where is the mafia when you really need them? Ah, that was a kinder, more genteel era now wasn’t it?

    2. Kay

      Mary, your story of your mother’s destruction at the hands of “medicine” is tragic and terrifying. As I was reading it, I was thinking that there really needs to be a place online where such stories can be collected, and somehow positioned so that they’ll come up at the head of the line when someone does a search for “statins.” I’m sure such a thing would never happen, but it SHOULD.

      Reply
      1. thelastfurlong

        There IS a site called spacedoc.com I just found it the other day. I’m trying to get my husband to taper off the statins. The site has MASSES of stuff on side effects and hubby is reading it. He recognises lots of stuff. – numb hands in the night and cramps. He cut his pills in half last night! So look at spacedoc .com

    3. Marie - Sweden

      Mary, thank you very much for telling the story of your mother.
      It`s a very sad story, but not an unusual one.
      I had a very close friend who went through something similar and died at the age of 74, prematurely aged. He had a heart attack when he was around 60 and from then on it was medication after medication. In those days we had no Internet and just trusted what was said and done.
      I will definitely print out some copies of your comment and give to people around me.
      I have noticed that people “wake up” when they read real-life stories and start to remember things they have forgotten.
      I will also give them an article by Canadian researcher/writer Alan Cassels who writes about medications, pharmaceutical industry etc. in a monthly column (Drugbust) at http://www.commonground.ca. In the latest issue, he has written about these new medications – “New cholesterol-lowering drugs coming”.
      I shall also recommend Dr. Kendrick`s book – Doctoring Data, but I wish it could be translated into other languages – for instance Swedish.

      Reply
      1. maryl@2015

        Marie, excellent information. I so appreciate your sentiments. You know, I had tapered her off many of the medications. She was on Aricept and Remeron for appetite. I also had her on a high potent vitamin D and Ubiquinol. She seemed to be doing better. When she broke her hip, she no doubt had dementia. But, she knew me and her close friends and family. I assumed they would just keep her on the same medications for the three week inpatient stay. Not so, I was to discover. Even her doctor was floored that they had her on so many medications as I took her to her doctor within a week of her coming home. She went down fast and hard. Thanks again for this information. It will no doubt help.

    4. Pat

      Mary, very sorry indeed to hear your news. Try to remember the good times with your Mother. Laughter helped me when my Mother died even though I was gritting my teeth.

      In time, when you recover from this please tell her story again quietly, with dignity (like you have done) to those who will listen. Prepare this first including a list of the medications. When an appropriate opportunity arises go public again. I really think this will help other people and might make some medics think again.

      Reply
    5. Nigella Pressland

      Sincere condolences Maryl. I lost my father not so long ago, it is tough. At least your mother is at peace now, no longer suffering. I hope this is of some comfort – it isn’t much but it helped me a little.

      Reply
    6. mikecawdery

      Baycol after a short spell was taken of the market because it killed. Left Bayer in financial crisis.
      The adverse reactions you describe are well known; Dementia (Alzheimer’s et al) is I believe is one of the worst of all adverse reactions but NO ONE is prepared to research the association of statins with dementias. It is the worst thing that can happen to someone to have the their mind and personality stolen. I commiserate sincerely with you and I too hate statins. They are the most dangerous poisons currently promoted by the medical establishment! Where has “Fiirst do no harm” gone.

      Reply
  24. merrilie2015

    Thank you Dr. Kendrick for all your research and straight forward explanations. It is really very frightening the number of intelligent people who I know who just insist that their Doctor must be right and I am unable to persuade them even to read up about it all, particularly the dreaded statins. I won’t put anything in my body that I haven’t researched thoroughly myself! Why can’t more people take some responsibilty for their own wellbeing??

    Reply
  25. Maureen H

    I don’t know why many people are reluctant to take responsibility for their own health. An unquestioning faith in the medical establishment? A reluctance to “deprive” themselves of things they love to eat? An attitude that nothing is wrong with the way they eat because they don’t have anything wrong with them (yet)? My own two sisters are very obese, one has severe knee problems due to TB of the bone as a child, so activity is difficult now but losing 50 pounds would sure help, she has told me she doesn’t want to hear anything about dieting. The other is around 250 lbs, very active; cycles, swim, walks, in fact a very ‘fit but fat’ person. But her doctor has warned her she is prediabetic and her blood pressure is up. She has been advised to take statins. She is 55. I think she is going to take them. My cautious attempts to steer her in the way of helpful information re cholesterol and statins, diet, especially the effect of grains, was met with hurt feelings and indignation, and “you’re not a doctor”. I don’t know what else to do, she very much resents my “interference”. Is it only when we are faced with a serious illness that the medical establishment can’t help with, that we finally take our health seriously and do our own research? From many accounts from people of this blog, it seems to be the case.

    Reply
    1. Marie - Sweden

      Maureen,

      I quote:: “She has been advised to take statins. She is 55. I think she is going to take them.”.

      Maybe you could suggest that she read the stories at:
      http://www.askapatient.com (search for all statins, they have similar side effects)
      http://www.spacedoc.net (lots of information)
      http://www.peoplespharmacy.com (search for statins)

      Earlier this year EMA/PRAC, a division working with drug safety in the EU decided that the pharmaceutical industry should add texts in package inserts etc. I enclose part of the text below.
      —————————————————————————————————————

      Pharmacovigilance Risk Assessment Committee PRAC recommendations on signals for update of the product information Adopted at the 6-9 January 2015 PRAC

      1. Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin – Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140) Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined):

      Summary of Product Characteristics (SmPC): Section 4.4 – Special warnings and precautions for use:

      There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.

      Section 4.8 – Undesirable effects: Musculoskeletal disorders: Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4)

      Package Leaflet: Section 2: Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

      Section 4: Side effects of unknown frequency: Muscle weakness that is constant.

      30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
      An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525

      Send a question via our website http://www.ema.europa.eu/contact © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
      ————————————————————————————————————–

      It has been known for years that people on statins can suffer from muscle weakness (my mother did) but it has taken many years before they admitted that it can persist even if you stop your medication.

      Reply
      1. Maureen H

        Marie,
        Thank you for those links, very very interesting. I would love to suggest to my sister that she take a look at them, especially Space Doc. But she has made it quite clear that she doesn’t want my advice, preferring to trust her physician 100%, who continues to encourage her to reduce calories, avoid fats, eat “healthy whole grains” and all that nonsense, and now to take statins.
        And Kay, I didn’t intend to sound as though I think it’s irresponsible of my sisters not to do what ‘I’ think they should do, but at least to look at some information that they may not be aware of then they can at least make an informed decision. Right now my younger sister’s decision to take statins isn’t an informed one. I’m very fond of both my sisters and to see their health declining when they could maybe do something about it, is very sad.

      2. mikecawdery

        As you know The SPC (summary of product characteristics) of all drugs is “Open Access” and can be downloaded from the EMA or MHRA websites. Also the MHRA has a database of the adverse reactions (ARs)of all drugs. Google “MHRA DAPS” choose drug and download. Incidentally the DAP of simvastatin runs to 55 pages. The last time I checked it reported 110+ deaths, which given a) the poor reporting rate of ARS and b) the “belief” that statins “save lives means that the real figure is probably in excess of 11,000. Add in the neurological adverse reactions (usually ignored you are getting old) and the damage to patients is totally unacceptable.

      3. Kay

        I went looking at Ask-a-Patient. Among the top ten reasons for taking Lipitor, I found:

        “2 Product used for unknown indication 28972”

        “6 Ill-defined disorder 5545”

        “10 Hypertension 1324”

        Good grief!

    2. Nigella Pressland

      It is a tough call to be your own health care advisor Maureen. I’ve recently done this for treatment for being hypothyroid. Before I decided to self-medicate, I did a tonne of research, really spent hours & hours looking through all sorts of published medical research, weighed up risks, looked at various pros & cons. In order to satisfy myself, I wasn’t being whimsical or bloody-minded, I had to learn the ins & outs of how the thyroid gland & hypothalamus function & their effects on the body – before I was prepared to take the step of self-medicating.

      I am not brain of Britain & it was a really tough slog, I found that wading my way through medical papers is like reading the bible, you can find a study to justify almost any stance! So I can really understand why so many people prefer to stick to the guidance of someone who spent 5 years at medical school!

      Reply
      1. S Jones

        Nigella, both the hypothalamus and the pituitary are part of the feedback system for TSH and thyroid hormone production. The hypothalamus monitors the levels of T3 and T4 in the blood/brain and releases TRH (Thyrotropin Releasing Hormone) in response. Thyrotropin is another name for TSH. So TRH levels determine how much TSH is released from the pituitary. And of course the thyroid releases T4 and some T3 in response to TSH. So both the hypothalamus and the pituitary are vitally important in the process.

  26. Kay

    Merrille and Maureen, I think many people *are* taking responsibility for their own health in the best way they know how — by being under a doctor’s care. For many, this seems to be working. When it doesn’t work, some turn to the internet and research. Some don’t. For those who do turn to the internet, as I’m sure you know, there is a vast amount of conflicting stuff out there. There’s plenty of party line propaganda that could cause some to worry that they’re doing the wrong thing by turning away from the established way. There’s a lot of very flimsy un-nresearched stuff that must be sorted through and evaluated. There are a variety of respectable approaches that will work for some and not for others. And so on. I feel I’ve found the best way to look after my own health. I believe the way I’ve found would be best for lots of others. But I don’t feel that others are being irresponsible for not doing things my way.

    Reply
    1. David Bailey

      I do agree that advising others what to do is always very difficult, and the internet is a law unto itself!. Nevertheless, I think the most basic evidence – such as the studies that are done to prove high cholesterol is bad, which end up proving somewhat the opposite – is always worth pointing out! I can’t see how this evidence can be tainted, even though it comes from the internet, since it comes with references to the actual research.

      Also, I think it is always worth suggesting that someone who is being offered statins, should ask a few friends of the same age about their experiences with these drugs. I only tried this after my love affair with statins turned bad (I used to think of them as my live-longer pills), but had I known the real frequency of side effects, I would never have started.

      Reply
      1. Maureen H

        Good suggestions David, a suggestion to ask others on statins their experience may be more acceptable than me suggesting a book to read (Dr. K’s would be perfect), or info on the net. I’ll give it a go!

  27. Dr. Göran Sjöberg

    Mary L, Robert, Kay, Merri and Maureen,

    I think your comments taken together just summarise my own thoughts pretty well about the complexity involved.

    It is possible to make individual changes but it seems to always be a fight involved wherever you try, medicine and probably hardest with the diet. When my own mother,e.g., was in a home for elderly she came to that home with the ‘typical’ long medicine list but I went through it together with a nurse and we both realised that nobody had given the list any serious thoughts before. The medicines had just hung on but we took a number of them away together, ‘to test’ and my mother turned much more communicable and it was much more pleasant to pay her our visits.

    Though, as Robert appropriately puts it, it runs very deep.

    How do you change a social system in which people are stuck?

    Still, I personally believe in a grass-root ‘revolution’ into healthy life having noticed the overwhelming benefits for many around me including myself and my wife, mainly by cutting the carbs/sweets, as a life style, even if this is a very though deal for most of us and a thought which takes time to arrive at, not least in an existing, ‘food drugged’, social system context. The driving force is here the effect of ‘the good examples’ and that people not possibly want to suffer from all kind of ailments and take associated medicines of all kinds where perhaps the statins are at the top of the list.

    Perhaps the ‘system’ has to crash completely, as always (?), before a revolution possibly can take off.

    Reply
    1. maryl@2015

      I think the system probably needs to crash but oh the price so many will pay. I feel badly mostly for the victims who suffer physically. I also consider all the working people who make a living off the industry all over the world really. And, can you imagine how many have investments in pharmaceutical companies in 401K’s etc or other savings programs like annuities for instance? Most don’t even bother to check to see how their funds are managed if they work for any large or small company or other institution. They just trust those in charge to make wise investment decisions. The tentacles run so far and wide, it is mind boggling. It would no doubt hurt many in more ways than one. I just don’t know the answer, but something’s got to give!

      Reply
  28. Kay

    Earlier, I commented that it would be good if a collection of stories like the one by Mariel@2015 could somehow show up at the top of the line when someone searched for “statins.” I did just that — googled “statins” — and at the top of the line of offerings was an ad for PESKY9, and endless other statin ads. HOWEVER, if a person thought to search: “statin” + “kill”, or “statins” + “harm”, some useful information comes up fairly well near the top of the list.

    Reply
  29. Marie

    I have just returned from seeing my umpteenth lipid consultant (it’s a bad habit I’m trying to give up) and apparently the new big thing in the world of heart disease prediction is Lp(a). Cholesterol is so last week. He insisted on checking mine, even though I said I’d rather he didn’t.

    Guess what lowers Lp(a). PCSK 9 inhibitors of course!

    How handy is that. Unfortunately there seems to be zero evidence that lowering Lp(a) actually lowers risk of heart disease.

    I sometimes think it’s a conspiracy to drive us all mad, and I’d get more sense reading my horoscope in the Daily Mail.

    Reply
  30. S Merlaud

    “NNT of 77” (for statins)
    That is , if you accept up front the studies this is based upon as flawless, non treacherous, honest, unbiased.
    Well no .

    Cholesterol and statins: Sham science and bad medicine [Kindle Edition]
    Michel de Lorgeril (Author) http://www.amazon.co.uk/Cholesterol-statins-Sham-science-medicine-ebook/dp/B00IU0SZUO/ref=sr_1_2?s=books&ie=UTF8&qid=1443274889&sr=1-2&keywords=de+lorgeril

    And (new PCSK9 sorcellery is also adressed) , in http://www.amazon.co.uk/Lhorrible-v%C3%A9rit%C3%A9-sur-m%C3%A9dicaments-anticholest%C3%A9rol/dp/2365491561/ref=asap_bc?ie=UTF8French

    Reply

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