Real Life vs. Pharma Company Studies

 

At what point, exactly, does credibility snap? When does the difference between what we are told, and what we observe, reach such a state of dissonance that it is no longer possible to believe both. Sometimes it seems the answer is ….never.

Here is one example. The clinical trials on statins found that they have virtually no adverse effects. Or, to be a little more accurate, that adverse events were virtually identical to placebo. Here, for example, is part of the press release from the Heart Protection Study (HPS).This was the last major placebo controlled statin study done in people with already diagnosed cardiovascular disease.

As the benefits of statins are now thought so wonderful it would be considered unethical to do a placebo controlled study anymore. You would be withholding statins from people who need them. Which means that you are not going to get any more evidence in this area – ever again. The HPS results were published around ten years ago, and the press release contained the following

‘Although muscle pain was reported by the participants, this happened about as commonly among those allocated the active simvastatin as among those allocated the placebo tablets. Despite 20,536 randomised patients having been followed for an average of five years, blood tests among people reporting muscle symptoms found only 11 simvastatin-allocated patients and 6 placebo-allocated patients with a rise in the muscle enzyme creatine kinase (CK) to more than 10 times the upper limit of normal Of these, 14 met the definition for “myopathy” (i.e. muscle symptoms associated with such CK elevations) of whom 10 were in the simvastatin group and 4 in the placebo group.’

http://www.ctsu.ox.ac.uk/~hps/June02QandA.shtml

Teasing these figures out a little more it seems that an extra six people taking simvastatin suffered muscle ‘problems’ than those taking the placebo. This is six people, out of more than ten thousand taking simvastatin. This represents in one thousand seven hundred and eight 1/1708 (over five years).

If this were true, then muscle problems should be exceedingly rare. The average GP with about two hundred of their fifteen hundred patients taking a statin should see a patient with muscle pains/problems about once every twenty five years. At this rate, you would not even know you had a problem.

Yet, wrapped around my copy of the BMJ last week was an advert for rosuvastatin [Crestor]. The strap line shouted out ‘Myalgia on his initial statin?’ [Myalgia is the medical word for muscle pain]. The main message the advert was… ‘If your patient was suffering muscle pains on their initial statin, they should switch to Crestor 5mg.’

Their ‘initial statin’ will almost certainly be Simvastatin 40mg. The drug, and the dose, used in the HPS study. The same drug, and the same dose recommended by the National Institute of Clinical Excellence (NICE).

Now, you do not run an expensive advertising campaign without doing a lot of market research first. What the market research must have told AstraZeneca – who make Crestor – is that a lot of people are suffering muscle pains on 40mg simvastatin.

Which means that simvastatin, which caused no discernible increase in muscle pains in the clinical study…… actually creates such a massive burden of muscle problems that a pharmaceutical campaign is running a major advertising campaign highlighting this, exact, adverse event.

What does this tell us, gentle reader? It tells us many things. Some of which would be considerable slanderous if I said them out loud. The most outstanding thing it tells me is that, although we have all been repeatedly informed that statins have no more side-effects than placebo, I now find that AstraZeneca encouraging doctors to switch statins due to the burden of side-effects.

F Scott Fitzgerald opined that …“The test of a first-rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function.’

I would suggest that there comes a point where you have to decide between which idea is right, and which is wrong. With regard to statins, I did this many years ago when I recognised that they cause a gigantic burden of adverse effects, with muscle pain the single most outstanding. I knew that the clinical trials had somehow or another managed to bury this fact.

Yet, when I speak to most doctors they continue to tell me that statins have very few side-effects, as do most opinion leaders. This belief, whilst AstraZeneca starts up an advertising campaign based on side-effects reported by doctors. F Scott Fitzgerland would be impressed by all these first class intellects. I just despair of them.

 

 

27 thoughts on “Real Life vs. Pharma Company Studies

  1. Charles Fairweather

    A little while ago I wrote to you about the effect Simvistatin had on me which was to rotate the room at 200 km per hour. I took the stuff back to my pharmacist who told me that a few years ago the drug company reps withdrew all the Simvistatin he had in stock as it was causing so many side effects. They have however reintroduced it again because it has now become very cheap. It now costs about 40 rands here in South Africa or less than 3 pounds of your currency. The cost of poison has gone down. What is more incredible is that my GP claims that her patients very seldom have side effects. makes you wonder.

    Reply
  2. dearieme

    A friend in his mid seventies tells me that far more of his friends have statin-induced problems than is compatible with the official claims on statins. Before he retired he was an epidemiologist.

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  3. albert

    I stopped taking statin 6 weeks after being put on them following a heart attack. In that short time I experienced loss of mental accuity and myalgia – only to be told by my GP that it was unlikely to be the statin. I didn’t believe him and stopped taking it and felt much better a week later – in all about a month latter and I felt more or less back to my old self. This led to a lot of reading up on statins and cholesterol which opened my eyes to the whole cholesterol con that we’ve been fed for the last 60 years. The medical profession has been pimped by big pharma – GP’s are simply drug pushers and it’s all about money and nothing to do with health. Now that WAS a big pill for me to swallow…

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  4. Susan Richardson

    Despair is the right word DK. You should be able to trust your doctor, but sadly we can’t. Mine would have put me on statins at the drop of hat if I’d responded positively to his suggestion that I was ‘at risk’. When I queried actually how much I was at risk, he looked it up on his computer and then admitted that it probably wasn’t very much in fact. Yes, it does make you wonder! How many people are actually suffering because of the medical profession’s obsession with statins. It’s sad that we feel we have to query our doctors because we don’t trust them, and unfortunately most people don’t – they just accept what they say and believe implicitly in what they are told. Don’t keep quiet Dr K.

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    1. Lo Phat

      Yes but with homeopathy there is a very fine line between what doesn’t work and what is completely useless so its difficult to get the dose just right.

      Reply
  5. dearieme

    Just a thought, Dr K. When did mass medication with statins start? I’m wondering when we should keep an eye open for an “unexpected” rise in mortality.

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    1. Dr. Malcolm Kendrick Post author

      Statins were first prescribed in the early 1990s. It is now thought that, in the UK, around six million people are taking them. (I suspect many are being prescribed statins without taking them). Personally, I do not think that taking a statin will reduce life expectancy by any detectable amount. They will just make you feel terrible.

      Reply
      1. dearieme

        Is that (your expectation of a lack of extra mortality) because you can’t see a mechanism by which they could have that effect, or some other reason?

  6. dearieme

    It occurs to me that if statins do their good (when they do any good) by mechanisms distinct from their cholesterol-lowering effects, their ought to be mileage in developing a new drug that amplifies those good effects and avoids the cholesterol-lowering which (I’m going to assume) is the source of the nasty side-effects. Dr K, have you ever heard of any work in that direction?

    Reply
    1. Roseanne Lannigan

      statins are highly dangerous as research in america by dr Beatrice Golomb has shown when you react the damage doesnt stop and yet no one in Britain seems to know much about the severity andthe ruining of your health which when started keeps on even after stopping seven years on every health problem attributed to this drug arthritis osteo arthitis brain tumour memory loss sleep deprivation depression severe leg cramps pain constantly divertiverticulitis prolapse of bladder and womb feet pain like barbed wireand swallowing problems a nightmare even had a pulse up my spine need op on back dont take them as i did no checks made on boods even though i went to doc eight times as my doc had left no one checked and its now history

      Reply
  7. nancylebovitz

    I’d consider an advertising campaign to be a modest level of evidence– it’s not as though people who run companies are omniscient or reliably competent.

    I’ve heard enough from other sources (including a woman whose husband took permanent muscle damage from statins) to believe that muscle pain from statins is a real problem.

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  8. David Anderson

    Part of the problem with statins, from my own experience, apart from their mind, personality changing and cognitive suppressing effects (all of which amounts to a pretty wretched experience) is that they also suppress one’s ability to self-judge the things that are happening to oneself. This I feel could well be a major reason why so many of these adverse effects (even with small doses in some people) go unreported to their doctors and specialists – who, being all members of the western medical tradition, all basically speak from the same hymn sheet and hardly ever take seriously comments from mere patients which are contrary to the accepted dogma they are fed from healthcare professionals and drugs salespeople.

    Also, which does not help matters, all western medical practitioners seem ultimately guided by statistics. But it depends on what circumstances and on whom the statistics are based. Much of the time the statistics are based on people who in some way or other are already abusing their bodies. So, should we all be guided by statistics?

    Reply
  9. David Anderson

    This is more of an after-thought to that which I previously submitted.

    Apart from the problem I see Dr Kendrick will have in his medical practice in reconciling his perfectly legitimate and evidencially supported findings from many people including myself with that of his local hospital specialists who no-doubt advise him to prescribe statins, often at high dose, to his patients, some of whom have been referred to hospital evaluation following a TIA for example, I wonder what the efficacy of prescribed treatments was prior to the advent of the statins drugs? It might be interesting to compare the statistics for treatment efficacy or disease mortality in both the pre and post statins eras. In this regard, assuming the categories of people used to compile the statistics were the same in both cases, such a comparison might be both believable and illuminating.

    The bottom line is, does there exist any efficacious treatment for atherosclerotic disease, or is the real truth of the matter that we should give up the idea of everyone living to a ripe old age and basically accept that nature (or God according to one’s belief or disbelief) has decreed that not everyone is intended to live a long life, and that we should accept our our inevitable mortality which for some people is intended to be sooner than for some others. Something gets us all in the end, despite all our attempts to avoid it. But, think on this, if death was not a good thing, would it have been invented?

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  10. Mike Henning

    After a nasty bout of leg pain a couple of years ago which left me more or less immobile, I stopped taking statins, and had a marked improvement after a couple of weeks; things were complicated by what turned out to be the need for a hip replacement. However, out of interest I carried out an informal survey of the experience of my friends who were on statins. About half of this small sample of around a dozen had muscle troubles, and most of them had just stopped taking the statins without bothering to tell their GP. At my next visit to the GP, I told him I would not be taking them again, and opined that the rate of muscular side effects was probably about 50%. Instead of laughing me out of court,he startled me by saying that in his opinion the rate was nearer 15-20%! How does this “hearsay” data square with the reported relatively miniscule rates?

    Reply
    1. Dr. Malcolm Kendrick Post author

      Adverse drug reporting is almost non-existent, especially when it is considered ‘non-serious’ e.g. muscle pains. There are a whole series of reasons for this. The clinical trials on statins report adverse event rates from 0.6% (Woscops), all the way up to 95% (Ideal). Always, the rate of adverse events in the placebo arm is that same as that in the drug treatment arm. Always – no matter what the absolute rate. So, one could opine that something looks very stange…..does it not.

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  11. Sue Lewis

    I.m a healthy, active 61 year old woman with normal weight and no history of CHD but as my cholesterol level is now 9.6 I have been prescribed simvistatin. After reading Dr Kendrick’s book I am extremely worried about the side effects v benefits and am convinced that in no time I will be diagnosed with Type 2 diabetes as a result of taking them. In my position would anyone else take them please?

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  12. mike cawdery

    An an ex-QP-pharmacovigilance for a veterinary company and having a particular interest in this subject, I was discussing statin adverse reactions with my GP as I personally have had several ARs w.r.t. to them. I asked him whether he routinely reported SARs to the MHRA. His answer shook me. To paraphrase “If I reported all the adverse reactions reported to me by patients, I would not have time to see any patients n the first place.” I suspect that may reflect the problem with many hard working GPs and indeed consultants.

    This leaves the MHRA DAP database with virtually no indication of the incidence of adverse reactions to any drug. The DAPs themselves provide very little useful information on ARs other than they actually exist. The incidence of ARs are of little concern to anyone in authority – only to those patients who suffer with little sympathy from their GPs et al.

    You mentioned the HPS study. The simple reason for the limited incidence of ARs in this study is that their exclusion/inclusion criteria successfully excluded potential intolerants and “non-compliants” from the study, the results of which therefore only apply to one third of the initial selection, ie., those who finally made it into the study proper. I raised these issues with the DoH to be told that it was “unethical” to treat intolerants but which is happening on a daily basis. The numbers of those not continuing treatment beyond one or two years confirms this view.

    The phrases “heart protection” and “cholesterol-lowering” were included in the title but no where in the report were the basic data on cholesterol levels w.r.t. to the main outcomes (death due to CVD, non-fatal CVD, survival) in the two treatment groups. Thus while the study showed that simvastatin did “save” lives, there is no evidence at all to show that this was due to the “cholesterol-lowering” claimed in the title. I did email the authors to try and get the data but never received a reply. But then I am only a vet.

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  13. The Healthy Epicurean

    I was on statins for almost two years; possibly the worst two years of my life. Ten years on, I am just beginning to ‘manage’ the damage (although I still have a damaged mitral valve) and have no qualms whatsoever about sharing my experience so other people might avoid this poison. When I think about it, I’m still raging at the doctors/cardiologists that wouldn’t listen or laughed in my face when I said that I was in pain and that my quality of life had taken a nosedive. One cardiologist told me that I would ‘definitely’ suffer a heart attack unless I took statins (I’m a slim, healthy, athletic female in her 40s with fairly high cholesterol – so what? – but no risk factors). Bastard; I should have sued him for moral harassment.

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  14. Margaret V

    After reading your book, I immediately ceased taking Crestor and I’m incredibly angry that I have been taking statins for 15 years for no reason. I respect my GP but next time I visit I will be telling him I have ceased taking this poison. He has quoted the JUPITER study for rosuvastatin as all the evidence required to prescribe this drug. What is your opinion of this study?

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  15. Pharmacynic

    I work in pharma, though not in the cardiovascular field and so this scandal has, somehow, and to my great embarrassment, passed me by.

    Dr K – I think there needs to be a Panorama programme about this. There are probably too many vested interests to get a commercial station interested.

    Reply
    1. Dr. Malcolm Kendrick Post author

      I think that the potential for corruption in this area is, indeed, a great scandal. However, it takes a lot of time and effort to get people to be bothered about it. A massive scandal is required.

      Reply

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