Another backlash begins

Recently I was the author, and co-signee, of a letter sent to NICE (the National Institute for Care and Health Excellence) asking that their recommendations on primary prevention of cardiovascular disease should be withdrawn. Mainly the advice on the use of statins for those at low risk of a heart attack, or stroke. Those in the UK may have seen a bit a stir in the media.

Others who signed this letter included: Sir Richard Thompson, Chairman of the Royal College of Physicians, Dr. Clare Gerada, past president of the Royal College of General Practitioners and Dr. Kailash Chand – deputy chairman of the British Medical Association. [I have included this letter for you to read, if you wish]

So, we are not talking about a bunch of mavericks here – apart from me, of course. When people who are as much a part of the ‘establishment’ as this are willing to put their names to such a letter then you know that people are getting very concerned. Very concerned indeed.

NICE wrote back to me saying that their guidance was completely wonderful and that nothing should change [I paraphrase, but not by much]. This was pretty much as expected. However, in parallel with this letter, the organisation that represents all GPs in the UK (the General Practitioner’s Committee of the BMA) voted unanimously to reject the NICE guidelines. This happened in May.

Now, very recently, the Annual Representative Meeting (ARM) of the British Medical Association debated the NICE guidelines. The motion put to the meeting was,as follows:

‘This meeting believes that in any advisory committee of NICE, when guidance on any drug is issued it must be made clear that none of the members must have a financial interest in pharmaceutical companies which manufacture the drugs’.

Here is the speech made by Kailash Chand to the meeting:

‘Chairman, Representative Body (RB). This is a chosen motion for a purpose. Some of you will have been very concerned about the general direction of travel by NICE, others will have been concerned simply by the issue of conflict of interest.’

This motion calls for clarity in the role of the pharmaceutical companies and their relationship with those individuals who hold positions of considerable influence on the advisory committees of the NICE, which describes and defines what many consider to be best practice.

This motion is NOT seeking to discredit people who advise NICE or indeed to diminish the Institute itself, which has a vital role in interpreting complex modern clinical evidence.

In fact, it is precisely because we should value the Guidance provided by NICE, that it is absolutely essential for it to carry the TRUST and complete CONFIDENCE of the profession. Guidance which has the power to influence our everyday practice, and against which many of us are performance managed must be based on the highest principles of INTEGRITY and TRANSPARENCY.

It is possible that those involved in an advisory capacity to NICE believe that they are able to manage their conflicts of interest, but it is absolutely imperative that NICE should not only be free of even subliminal influence from the pharmaceutical industry, but perhaps even more importantly, be SEEN to be completely independent and not reliant on partial data disclosure of pharmaceutical industry trial data.

Today, we see a lack of confidence from the profession in NICE’s capacity to analyse data and provide reliable advice, when only selective trial information from drug trials is made available.

Recently, the conference of LMCs unanimously passed a motion calling upon NICE to defer a decision to recommend a reduction of the threshold for prescribing statins for primary prevention in the general population.

The BMJ, the Cochrane Institute and indeed this Conference last year called upon the pharmaceutical companies to release ALL data, as a means to increase transparency and to allow more independent verification of results. In fact NICE itself has joined this coalition to call for access to this data, yet continues to place itself in a position of advising with access to only limited information – the pharmaceutical industry have widely ignored these calls for transparent disclosure.

We know that pharma sponsored trials are twice as likely to produce positive results for a drug, and we also know that only half of trials are available in a published form for peer review. This excludes trials which may be stopped prematurely or have end points altered by the sponsors.

Earlier this year the Cochrane Review concluded that the early evidence which had shaped the advice from NICE before the Flu pandemic, had been flawed and had resulted in an exaggerated impression of the usefulness of these medications. The absence of transparency in the process by which data was released and then interpreted has been deeply regrettable. Some have called it a gross betrayal.

So, please support this motion. It is a call for NICE to review its methods where advisory boards may be populated by individuals with links to industry. NICE needs to recognise that those of us tasked to implement its guidance must have full confidence in the transparency and integrity of those individuals providing advice. NICE must be beyond reproach. It should not just be SEEN to be independent, it MUST be independent.

Otherwise its advice which most of us have to implement or adhere to, will continue to affect the lives of millions of patients.

I move.’

This motion was passed unanimously.

Once again, NICE is under fire. This time from the entire medical profession, and those who represent them. It seems that doctors are deeply concerned about the medical evidence. They feel it has been corrupted, and that those who sit on the guideline committees are, themselves, under the influence of the pharmaceutical industry.

Hoorah. Will anything change? I shall keep throwing rocks, or course. Now a few more powerful rock throwers are joining in. Perhaps the citadel will crumble.

Letter sent to NICE:

Professor David Haslam, Chairman
National Institute for Health and Care Excellence
10 Spring Gardens
London, SW1A 2BV

cc. The Right Honourable Jeremy Hunt, MP
Secretary of State for Health
Department of Health
Richmond House                                                                                                                                         79 Whitehall
London, SW1A 2NS

10th June. 2014

Concerns about the latest NICE draft guidance on statins

Introduction:

We are concerned about your draft guidance on CV risk for discussion and debate. We would ask for a delay until our concerns are addressed. Whilst we agree with much of the guidance, our concerns focus on six key areas: medicalization of healthy individuals, true levels of adverse events, hidden data, industry bias, loss of professional confidence, and conflicts of interest

The draft guidance recommends offering statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.

1. Medicalisation of five million healthy individuals.

Firstly, we believe that the benefits in a low risk population do not justify putting approximately five million more people on drugs that will then have to be taken lifelong.

The important questions for clinicians and for patients include: (1) does treatment of elevated cholesterol levels with statins in otherwise healthy persons decrease mortality or prevent other serious outcomes? (2) What are the adverse effects associated with statin treatment in healthy persons? (3) Do the potential benefits outweigh the potential risks? Recent papers have suggested that statin therapy should not be recommended for men with elevated cholesterol who are otherwise healthy.2

Furthermore, Atorvastatin 20mg is also recommended as the first-line treatment. This appears counter intuitive, as Atorvastatin has never been demonstrated to reduce mortality for primary prevention any clinical study. (3b)

2. Conflicting levels of adverse events

In emphasising the cost per Quality Adjusted Life Year (QALY), NICE is clearly making a major assumption that the key issue is mortality reduction, and that statins lead to very few adverse effects. We would question this very strongly.

The levels of adverse events reported in the statin trials contain worrying anomalies. For example, in the West of Scotland Coronary Prevention Study (WOSCOPS, the first primary prevention study done), the cumulative incidence of myalgia was 0.06% in the statin arm, and 0.06% in the placebo arm3.

However, the METEOR study found an incidence of myalgia of 12.7% in the Rosuvastatin arm, and 12.1% in the placebo arm4. Whilst it can be understood that a different formulation of statin could cause a different rate of myalgia, it is difficult to see how the placebo could, in one study, cause a rate of myalgia of 0.06%, and 12.1% in another. This is a two hundred fold difference in a trial lasting less than half as long.

Furthermore, the rate of adverse effects in the statin and placebo arms of all the trials has been almost identical. Exact comparison between trials is not possible, due to lack of complete data, and various measures of adverse effects are used, in different ways. However, here is a short selection of major statins studies.

AFCAPS/TEXCAPS: Total adverse effects losartan 13.6%: Placebo 13.8%

4S: Total adverse effect simvastatin 6%: Placebo 6%

CARDS: Total adverse effects atorvastatin 25%: Placebo 24%

HPS: Discontinuation rates simvastatin 4.5%: Placebo 5.1%

METEOR: Total adverse effects rosuvastatin 83.3%: Placebo 80.4%

LIPID: Total adverse effects 3.2% Pravastatin: Placebo 2.7%

JUPITER: Discontinuation rate of drug 25% Rosuvastatin 25% placebo. Serious Adverse events 15.% Rosuvastatin 15.5% placebo

WOSCOPS: Total adverse effects. Pravastatin 7.8%: Placebo 7.0%

Curiously, the adverse effect rate of the statin, it is always very similar to that of placebo. However, placebo adverse effect rates range from 2.7% to 80.4%, a thirty fold difference.

3. Hidden data

Without access to the raw data, it is difficult to understand how statin related adverse events, and placebo related adverse events can mirror each other so precisely, whilst the absolute rates can vary thirtyfold (almost three thousand per cent). These data most certainly require analysis by a third party with appropriate expertise.

A further serious concern is that the data driving NICE guidance on statins comes almost entirely from pharmaceutical company funded studies. Furthermore, these data are not available for review by independent researchers, only those who work for the Oxford Cholesterol Treatment Trialists Collaboration (CTT).

The CTT has commercial agreements with pharmaceutical companies which apparently means that they cannot release data to any other researchers who request to see it. Which, in turn, means that the latest reviews of the data by NICE and also by the Cochrane group are totally reliant on the CTT 20121 meta-analysis analysis of this concealed data?

4. Industry bias

The overdependence on industry data raises concerns about possible biases. Extensive evidence shows that industry funded trials systematically produce more favourable outcomes than non- industry sponsored ones.5,6

Notably, only one major non-industry funded study on statins has been done. ALLHAT-LLP. The main findings were summarised: ‘Although pravastatin has been shown in multiple large clinical trials to reduce CHD morbidity and mortality, NO benefit was demonstrated in ALLHAT-LLT, the largest clinical event trial of pravastatin published to date.’ (6b)

True levels of adverse events

We are also concerned that the rate of adverse effects in post-marketing studies is, in most cases, far higher than that found in the pre-marketing studies. In part this is due to the fact that the clinical trial populations studied in premarketing trials are highly selected. Furthermore, industry sponsored trials include pre-randomisation run-in periods where those who fail to tolerate statins are excluded.RCT patientsmay therefore not represent the population that will actually take the drugs in the real world. RCTs may thus grossly underestimate adverse effects such as myopathy or cognitive impairment,7 and fail to detect drug interactions e.g. amlodipine and statins.

Important findings from some other non-industry sponsored studies

A double blind randomised controlled trial that compared 1016 low risk patients receiving simvastatin 20 mg or pravastatin 40 mg with placebo showed that both drugs had a significant adverse effect on energy/fatigue exercise score with 40% of women reporting reduced energy or fatigue with exertion.9 Reducing exercise capacity in a healthy group when physical inactivity is a major contributor to the development of cardiovascular disease is extremely counterproductive.

A large observational study involving 153,840 postmenopausal women aged between 50 and 80 years enrolled in the Women’s Health Initiative study found that statins were associated with a 48% increased risk of developing diabetes.8

Potential psychiatric symptoms including depression, memory loss, confusion, and aggressive reactions have also been associated with statin use.(10)

Erectile dysfunction, to take another significant adverse effect, is not mentioned in the statin trials. Yet, when it was specifically looked for, around 20% of men appeared to be affected.(11)

5. Loss of professional confidence

We are also concerned that GPs feel that this guidance is a ‘step too far. It is instructive to note that a survey of 511GPs carried out by Pulse magazine revealed that ‘….almost six out of ten (57%) oppose the plan to lower the current 10-year risk threshold for primary prevention, while only 25% support it. Furthermore, 55% would not personally take a statin or recommend a family member does so based on a 10% 10-year risk score.’ (11b)

More recently the General Practitioners Committee (GPC), which negotiates on behalf of GPs in the UK passed the following resolution: ‘In light of the Cochrane review of the effectiveness of antiviral influenza treatments, the GPC will request that NICE refrain from recommending a reduction to the current treatment threshold for primary prevention of cardiovascular disease with statin therapy unless this is supported by evidence derived from complete public disclosure of all clinical trials’ data’ (11c)

Asking GPs to meet targets that they feel uncomfortable with risks a damaging split within the profession, and a loss of confidence among the public, who are likely to recognise increasingly that GPs are being asked to prescribe statins despite feeling it is inappropriate.

6. Conflicts of Interest (real and perceived)

We are also seriously concerned that 8 members of NICE’s panel of 12 experts for its latest guidance have direct financial ties to the pharmaceutical companies that manufacture statins. Furthermore, some members of the guideline panel are also involved in next generation, more expensive, cholesterol lowering drugs, which are not yet on the market. If cholesterol lowering becomes established in low risk people, the indications for these new cholesterol lowering drugs such as the ApoB Antisence drugs and PCSK9 inhibitors will probably expand as well. We feel that parties with industry conflicts should not be participants in generating recommendations regarding drug use that will influence medical care across the population.

We fear that the CTSU could be perceived as having a major conflict of interest in the area of cardiovascular disease prevention/lipid modification, which has an impact on the Unit’s perceived objectivity. We strongly urge that other researchers, for example, the Cochrane Stroke Group and Cochrane Heart Group, should be able to scrutinize and assess all the data that the CTT has utilised over the years to produce their extremely influential studies.

CTT is a part of the Clinical Trials Service Unit (CTSU) in Oxford, which has carried out many very large studies on statins, and other lipid modification agents with pharmaceutical company support, and has received hundreds of millions in funding over the years. To consider just one such study (REVEAL). REVEAL is being funded by Merck Sharp & Dohme, which developed anacetrapib. A grant of £96 million towards the cost of this multi-million dollar study has been provided to the University of Oxford.

We are concerned that financial conflicts of interest and major commercial bias may have corrupted the database on statins, resulting in an underestimate of the incidence of statin side-effects. Unless all of the data are made available it is impossible to establish a cost per QALY, as there may be DALYs [disability adjusted life years] not accurately accounted for.

We call for all of the data from the clinical trials to be made available to credible researchers, for example, the Cochrane Stroke and Heart Groups. We believe that there is a need for a more robust post-marketing analysis of suspected adverse effects from statins prescribed in a community setting.

To conclude we urge you to withdraw the current guidance on statins for people at low risk of cardiovascular disease until all the data are made available. The potential consequences of not doing so are worrying: harm to many patients over many years, and the loss of public and professional faith in NICE as an independent assessor. Public interests need always to be put before other interests, particularly Pharma.

Yours Sincerely

Sir Richard Thompson, President of the Royal College of Physicians

Professor Clare Gerada, Past Chair of the Royal College of General Practitioners and Chair of NHS Clinical Transformation Board

Professor David Haslam, General Practitioner and Chair of the National Obesity Forum

Dr J S Bamrah, Consultant Psychiatrist and Medical Director of Manchester Mental Health and Social Care Trust

Dr Malcolm Kendrick, General Practitioner and Member of the British Medical Association’s General Practitioners sub- Committee

Dr Aseem Malhotra, London Cardiologist.

Dr Simon Poole, General Practitioner

David Newman, Assistant Professor of Emergency Medicine and Director of Clinical Research, Mount Sinai School of Medicine, New York

Professor Simon Capewell, Professor of Clinical Epidemiology, University of Liverpool

 

References (may require site registration or membership to access)

1: Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C: ‘The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials.’ Lancet. 2012 Aug 11;380(9841):581-90. May 17.

2: Redberg RF, Katz MH. Healthy Men Should Not Take Statins. JAMA. 2012;307(14):1491-1492. doi:10.1001/jama.2012.423.

3: http://www.nejm.org/doi/full/10.1056/NEJM199511163332001#t=articleDiscussion

(3b) http://www.health-heart.org/Pfizer’s49LipitorStudies.PDF

4: John R. Crouse, MD; Joel S. Raichlen, MD; Ward A. Riley, et al: ‘Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis’: The METEOR Trial JAMA. 2007;297(12):1344-1353. doi:10.1001/jama.297.12.1344

5: Smith R. Conflicts of interest: how money clouds objectivity. J R Soc Med 2006;99:292-7.

6: Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. Jama 2003;289:454-65.

(6b) http://www.lipidsonline.org/commentaries/cme_pdf/commentary_039.pdf:

7: Mansi I, Mortensen E. The controversy of a wider statin utilization: why? Expert Opin Drug Saf 2013:12:327-37.

8: Culver AL, Ockene IS, Balasubramanian R, Olenzki BC, Sepavich DM, Wactawski-Wende
J, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s
Health Initiative. Arch Intern Med 2012;172:144-52.

9: Tatley M, Savage R. Psychiatric adverse reactions with statins, fibrates and ezetimibe implications for the use of lipid-lowering agents. Drug Safety 2007;30:195-201.

10: Golomb BA, Evans MA, Dimsdale JE, White HL. Effects of Statins on Energy and Fatigue With Exertion: Results From a Randomized Controlled Trial. Arch Intern Med. 2012;172(15):1180-1182. doi:10.1001/archinternmed.2012.2171.

11: Solomon H1, Samarasinghe YP, Feher MD, et al: ‘Erectile dysfunction and statin treatment in high cardiovascular risk patients.’ Int J Clin Pract. 2006 Feb;60(2):141-

(11b) http://www.pulsetoday.co.uk/clinical/therapy-areas/cardiovascular/majority-of-gps-reject-nice-proposals-to-extend-statins-to-millions-more/20005985.article#.Ux3eGPmKVcY

(11c) http://webappmk.doctors.org.uk/Session/2779737-8NrQN5n75yPDD0RVnLZy-aoqmids/MIME/INBOX/125049-02-B/News%2014%20-%2022%20April%202014.pdf

63 thoughts on “Another backlash begins

  1. mikecawdery

    I too wrote to NICE complaining about their proposal to advise treatment and presented examples of where the current advice was based on flawed studies and subsequent extrapolation of results to those specifically excluded (HPS adverse reaction incidence) missing data (HPS), faulty interpretation of published results (European cardiovascular disease statistics 2005 and later) and hidden removed data on the claimed CHF epidemic by the US NHBLI and CDC.

    Response ignored everything and suggested that I joined a stakeholder, most of which were Big Pharma or charities (?dependent on grants?)

    As a more recent example try

    http://eurheartj.oxfordjournals.org/content/35/3/131.full.pdf+html

    The last two relevant pages are “blocked/removed”. MORE HIDDEN DATA!! when report concludes 800,000 deaths in five years!

    http://mesell.biz/myblog/?p=1227

    This gives Mercola’s view with the following comment extracted:

    Paper Removed for Peer Review
    Interestingly, the paper that summarized the action taken to stop using the drug that was killing hundreds of thousands was quickly removed from the European Heart Journal’s website, without explanation. Husten followed up with the journal, and was told that, due to an oversight, the paper had not been peer-reviewed prior to publication.
    Yeh! any excuse to remove it. In the US the death rate from iatrogenic causes is estimated at 200,000 per year or even greater and is third after CVD and cancer in the importance rankings!

    No wonder the medical working profession is jaded with NICE. The patient public too is rapidly becoming jaded with the apparent HERD method of diagnosis and the “Emperor’s New Clothes” type of drug promotion.

    Reply
  2. Angela Clubley

    Read this about statins situation. It’s by eminent doctors ie chairman of royal college of physicians. Note, read right to end.

    Sent from my iPhone

    >

    Reply
  3. Flyinthesky

    A great start with some top level influence on board but one has to be mindful that until someone is able to mortally wound the cholesterolosaurus it will remain a high stakes ping pong game.
    It isn’t just the expansion intent that has to be addressed it’s the fundamental concept. That is the most difficult aspect, conceding to the reality would lead to some very important people getting very red faces. To save face the tapering down, 5mg here 5mg there, won’t be reported and could take a decade, during this period a new gravy train will be found and the monstrosity forgotten.
    Let’s not forget now, no more than 5g of salt a day and no more than five teaspoons of sugar.

    Reply
  4. Clutter

    The thought that some GPs will prescribe statins (or anything) despite misgivings of the appropriateness of such interventions in order to comply with imposed guidelines from bodies who may have conflicts of interest is very disturbing. Perhaps provision of raw data and the publication of ALL trials being conditional on granting of drug licenses would convince big pharma? Keep chucking rocks Dr. Kendrick. Transparency is vital to ensure professional and public trust.

    Reply
  5. robert

    Hmmm. Incidence of side effects on statin arm = incidence side effects on placebo arm…

    You know, I’m pretty sure if you asked normal people what they thought about that, most of them would tell you it looked like both arms had been given the exact same stuff. And that is very convenient if you define the harmfulness of a drug by the amount it raises incidence of side effects above the placebo arm.

    A fish rots from the head down.

    Reply
    1. David Bailey

      I have another theory about the “statin arm = incidence side effects on placebo arm” issue!

      I think the fact that statins cause serious muscle problems is so well known by now that if you give someone a placebo and tell them it is a statin, they react out of fear of the real thing.

      I talked to a woman just today, who told me her husband was having real problems taking his statins because of the horrible effects on his muscles.

      In my experience, almost EVERYONE above a certain age has heard about the side effects of statins except the learned medical boffins!

      I am sure that if you gave people a placebo potassium cyanide capsule, some would collapse, and maybe even die! That would not make potassium cyanide safe!

      Even so, I wouldn’t discount Robert’s theory – maybe an ethics committee somewhere decided (in secret) that statins are so good that none of the patients should be deprived of their benefits!

      Reply
      1. thetinfoilhatsociety

        That is true and the placebo effect may indeed be in play. But. How many people get brushed off by their physicians/medical providers when they complain about aches and pains? Significant numbers, I would guess, especially because I work in the medical field and see disastrous outcomes of patients every time I go to work. Many of these, I suspect, are related to statin use – dementia, diabetes, profound weakness. I even see muscle wasting in patients who weren’t on statins before they came into the facility but now are on one. No one except me questions the connection.

        And this past week at work, I was required to sit through a “lecture” by a cardiologist that was basically a commercial for statins (and did I mention he used to work for a certain very large pharmaceutical company?) in which he said that your cholesterol numbers don’t matter, you should just take the drug, it helps lower your risk even though it might not help your numbers at all. How’s that for double speak??

      2. thetinfoilhatsociety

        No one except me questions that THERE MIGHT BE a connection. I hate when my fingers outspeed my brain.

      3. Suzanne Looms

        In my experience many people have NOT heard about statin side effects and feel intimidated by doctors, who dissuade them from stopping the medication.

    2. Stephen Rhodes

      Good spot.

      When you are only looking for positive results why do you need to run a separate ‘real’ control group when you can run ‘virtual’ groups.

      Far easier to give everyone the drug, then put all those subsequently showing a benefit in the ‘statin’ group and all the rest in the ‘control’ group.

      It is joke science, except the only ones in on the joke are those running the trials – double-blind my arse, this shows that those running the trials were manipulating the results to suit their financial ambitions! Lamp posts anyone?

      This explanation should be widely suggested in blogs on the web, particularly in the UK and US.

      Reply
      1. robert

        Yes, that is an option too. There is only one sensible way out. We need all of the raw data released. Any study involving a substance that is intended to be sold as a drug, prescribed by doctors, handed out by pharmacists… must be released to the public, pre-market, after-market, whatever. We need to know everything. Full disclosure. Fail to comply, no license / license revoked, no approval, no money. It is quite simple.

        If I had to speculate, I’d say this is not going to happen without significant motivation / incentive from the patients. We may have to wait until enough people just say NO to all of this.

        As a patient, once you have realized how powerful nutrition actually is, you will find it hard to just pop another pill ‘just in case’ or to get slightly better lab values or to pacify your Dr.’s lipophobia, paid for by feeling like shit, taking a 2nd pill to fight the side-effects of the first one, which you might not really need, if you just ate right for your body / genes. You won’t accept being told that you just imagine things, that nutrition doesn’t have anything to do with “it”. This kind of awakening cannot be taken away and if the current medical profession doesn’t watch out, they will run into serious trouble. I have yet to find a Dr. that does not write a drug prescription as the first choice of attack against a health problem – dentists excluded. They just drill it out.

        End of rant.

  6. V

    I, for one, would look at it the other way around.

    How are the statins working and what exactly do they do? The answer: they cut a VERY long chain of extremely useful enzymes, co-enzymes and other stuff in order to… what? Lower cholesterol. Which is damaging in itself to heart patients, who stand for very little benefit – but a tremendous amount of pain. I should know, I’ve been there.

    Now, what bothers me most is the language some you guys use. I know all about semantics and synonyms, but trust me it’s there. A religious adverse effect – linguistic or not; it’s there. Nowadays it seems like nobody ‘thinks’ anymore – everyone ‘believes’. Well, forgive me, but I’d very much prefer one who THINKS, ASSUMES, ASSERTS, CONSIDERS, PONDERS something crucial for my life (and that of others) instead of one who BELIEVES. Any day.

    And believe it or not, ALL of our major health problems are actually dietary problems that can be solved by dietary means. The rest is B.S.

    Other than that, one more encouraging sign, Dr. K – thanks a million for it! :)

    Reply
  7. Wendy Drane

    While I accept that NICE is an essential organisation I, as a non medical person, am grateful that guidance is not always accepted without due consideration by medical professionals. One of the things in the letter which leaps out at me is the fact that in the pre-randomisation run in trials those who cannot tolerate statins are excluded. How can this give an accurate picture of what will happen later when prescribed for the in general population? Clearly it can’t. I have been following the debate with interest since my brother, a “healthy” person developed a severe myopathy after taking precautionary statins for two weeks. They were withdrawn when the adverse effects became obvious but it was too late. Four years later his continued decline, with progressive muscular wastage , leaves him largely dependant on a wheelchair use. He is unable to stand straight and has an uncertain future as his heart and lungs become affected . If only, if only he had never taken statins.

    Reply
    1. Dr. Malcolm Kendrick Post author

      Wendy. This is why I am so anti-statin. If they caused muscle pain which simply went away when you stopped taking them, so what. If the NHS wants to waste several billion pounds on a drug with benefits so vanishingly small that you need thirty thousand people in a clinical trials lasting five years to demonstrate marginal statistical significance – so be it. My problem is that the adverse effects can be permanent.

      Reply
      1. Helen

        The pool of statinated persons in the UK is expanding at a time when Legal Aid has been withdrawn for cases of medical negligence (among other things). So, if you become so unwell or disabled by the side effects that you can no longer work, you won’t even have access to funds to sue for redress. Large sums awarded to patients in publicised civil cases would probably be the only thing that could switch the current trend into swift reverse. Persuasion can take decades – you have to wait for all that eminent opinion to die off.

    2. Stephen Rhodes

      Your gratefulness is likely misplaced.

      The reality is that the beancounters who have taken over the NHS are using the ‘guidance’ and QOF to control what doctors do. If they chose to ‘disobey’ the guidance the can be deemed to be underperforming and bullied into compliance.

      I now have no confidence in the medical establishment to act in my best interests and will now always check and double-check any advice or treatment offered. This is something that I have to thank my GP practice for since their pressing me to take a statin and my subsequent reactions to it (followed by the offer of a different statin and calcium channel blockers) prompted to me to investigate for myself.

      As a result I have now also stopped taking Ace Inhibitors, preferring instead to re-awaken my love affair with my Bob Jackson (bicycle since you are probably wondering) lose over 2 stone in weight and cycle over the Beacons. I have no idea what my cholesterol is, nor my blood pressure, and frankly I don’t care – I can cycle with my heart rate well over twice resting for hours on end and if I drop dead it will be while doing something I enjoy, rather than sucking oxygen in an old folks home trying to remember who I am.

      Reply
      1. mikecawdery

        I have been trying to get this recognized for some time. Also the fact that diagnosis by epidemiological “risk” is simply HERD diagnosis and if an individual falls in to a HERD (in this case cholesterol) the whole herd is treated. Dr Kendrick has pointed out the potential benefit is trivial. Recently Prof. Sir Rory Collins emphasized this when he claimed “if 3 million treated, 10,000 lives saved per year”. This is, in reality, saying that 3 lives per 1000 treated will be saved per year but in less promotional terms and is the figure which I found based on the original study publication (HPS 2004-5?).

        What is totally ignored is the 997 that do not benefit but may well be exposed to as high a rate of adverse reactions of 1 in 4-5.

        All the medical establishment is doing is to try and emphasize the trivial and divert attention from the disadvantages all for the financial benefit of Big Pharma and its “KOLs”.

      2. mikecawdery

        Control of docs by guidelines. Absolutely true. If they do not follow the guidelines they could be sued, charged with negligence and no doubt “struck off”

        In contrast, the authors of the guidelines are protected because they are “only guidelines”. In short a whitewash even though the guidelines are grossly flawed.

      3. Stephen Rhodes

        “In contrast, the authors of the guidelines are protected because they are “only guidelines”. In short a whitewash even though the guidelines are grossly flawed.”

        To which, if you add the current TTIP (Transatlantic Trade and Investment Partnership) being negotiated between the USA and EU, the drug companies will not be subject to any litigation for any damage you receive if you ‘agree’ to take their potions.

        Not sure where this leaves doctors though – the Nuremberg Defense didn’t work so well in 1946.

      4. Jennifer

        Stephen…ditto….ditto…ditto!
        I am buzzing around Kew Gardens all this week on my hols….even the bees are having trouble keeping up with me…..and I have so far managed to dodge incessant GP phone call endearments, (yes….they even get me on my mobile when I am away from home), to be tested for this, that and the other…..but no doubt I will return home to a little white envelope with the request in writing. When will the message get through?…..I am too busy living my life to the full, to make time to have my health scrutinised to the nth degree, and I am really not wanting to justify to ANYONE my non-compliance to ingesting endless medications, any more than I intend telling my mobile supplier the reason for switching to another company. Please….just leave me alone, both of you, you are using the same irritating tactics of trying to bully me into submission..( for your own financial reasons, ‘cos neither of you are the least bit interested in my actual needs), and it is just not acceptable.
        It will take a lot more of us to wake up and smell the coffee, absorb the wonderful things around us, and simply enjoy life outside the clutches of the NHS, before things change for the better. I just wish I were a trend-setter…..but alas….I am just an awkward old wrinkly.

      5. Felonious Grammar

        Ask your doctor about Ennui.* It’s better than placebo in a statistically significant way!

        Are you treatment resistant? Do you believe that your medications aren’t working? Do you think you feel worse now than ever before? That’s a symptom of mental illness— a condition called “agnosia” — but don’t worry, there’s a safe and effective treatment now.

        Ennui. It’s an adjunct to any cocktail of neuroleptics, benzos, antidepressants, meth-amphetamines, “mood stabilizers”, sleep aids, and off-label prescriptions at the same time. In the same body. There’s room for one more honey. Always. Ennui.

    3. David Bailey

      Wendy,

      I don’t know if this observation is of the slightest use to you, but I was given diclofenac for the pain – initially before I realised the problem was statins, and then afterwards to cope with the lingering effects. With diclofenac, I could exercise and over a period of about 9 months I reduced the dose (using the 25 mg pills rather than the 50 mg ones, then taking one every other day) until I was back to normal.

      I am not quite sure what might have happened without the diclofenac, since I could not have really exercised. Maybe Dr Kendrick can comment.

      Reply
      1. mikecawdery

        Diclofenac? This NSAID is, I understand, under suspicion for causing serious adverse reactions. I also notice that in the UK, there is a trend to prescribe paracetamol (aka acetaminophen) + codeine rather than traditional? NSAIDS. Acetaminophen in the US is apparently the drug which causes most iatrogenic deaths – but not to worry.

      2. David Bailey

        Mike,

        Diclofenac is indeed under something of a cloud, but if you feel your mobility is at risk, that is a small risk you are probably prepared to pay! The point is that for me, it seemed to ease the cramps and joint pains that otherwise made exercise almost impossible. Then the exercise seemed to help a lot. Remember, I was responding to Wendy, whose brother has sadly become almost wheelchair bound as a result of statins.

        The problem is that because statin damage is hardly recognised by the medical profession, I guess there are no guidelines as to how to treat it – so personal experience is relevant.

      3. mikecawdery

        David,

        First, your second para is absolutely correct – totally agree.

        Second, re diclofenac. I was just raising the adverse reaction issue because NSAIDs have a reputation for them. Of course if one is tolerant to a drug AND it benefits, that is a good reason to use it. However, the current practice of herd diagnosis (aka epidemiological diagnosis) which only identifies the herd, not the individual, is frankly wrong; shotgun therapy in mathematical clothing.

        Personally, I stick with aspirin, tolerant to it for 80 years. Intolerant to several of the new drugs.

      4. David Bailey

        Mike,

        I guess the point here is that if someone has a bad reaction to statins, they aren’t well people who are probably best advised to avoid medicines, they are sick ones, and from what I read here, that sickness doesn’t always clear up when the statin is stopped.

        Someone needs to figure out the best way to treat such people – otherwise they just get fobbed off in various ways, and some deteriorate badly as in the case of Wendy’s brother.

        I get the impression you are a doctor, so what would you do with such patients? I somehow doubt that aspirin would have been powerful enough – though I didn’t try it!

      5. mikecawdery

        David,

        Not a doc (medicine) but a research vet of some 60 years. Epidemiology main area but involved with drugs as a consultant and QP-pharmacovigilance (ie post-authorization which relies on docs/vets reporting adverse reactions to the MHRA/VMD). Unfortunately, the degree of reporting is very poor!

        I have suffered adverse reactions to statins and having read books and research papers on the subject I am frankly horrified at the way negative studies are ignored, how data is selected to promote statin use while contrary data is hidden/not published. Having trained at the LSH&TM when research integrity was paramount, I find the present situation where it is nothing and has been replaced by money and status as paramount to be totally unacceptable. Books by Marcia Angell (ex-chief editor, NEJM), Ben Goldacre and James LeFanu all point to the same problem – lack of research integrity. Huge fines (US) on drug companies further support my contention of lost integrity.

        Rant over

    4. Mark John

      I had no idea that a statin’s adverse effects could be so rapid and so irreversible.

      Thank you Wendy for posting your brother’s extremely sad and upsetting experiences. I and many others are I’m sure, much the wiser for it.

      Reply
  8. gilbert78

    Wendy; It is generally known that muscle can be affected by Statins in very few people,( as the advice sheet states) but so quickly, with your Brother only taking them for two weeks, that is frightening. Also the advice blurb advises that if it does occur then muscle will quickly recover if action taken. Not so in all cases clearly. Discussing this today with a friend ,he had a colleague prescribed statins and as his cholesterol did not change the GP doubled the dose!! , he too never recovered from muscle wastage.
    How many such cases are there that go unreported and how do these GP’s live with their conscience?
    Hopefully every one reading this blog will copy it to all in their Contact list in an attempt to spread the word. I also wrote to my MP listing two anti -statin books asking him to pass them to the Health minister and request that his researcher read them on his behalf and give him a synopsis. I did at least get a reply form both parties but no action promised ;… but The above letter to NICE may just stop this ball rolling.

    Reply
    1. mikecawdery

      “It is generally known that muscle can be affected by Statins in very few people,( as the advice sheet states) ”

      When up to 20% (even 9% admitted by Collins) of those taking statins have adverse reactions, the “advice sheets” are clearly not correct – more bamboozling by the medical establishment.

      Reply
    1. celia

      Dr Kendrick, thank you for sharing all this in full. I do so hope it will have the required and necessary response, for the sake of both the doctors and us patients. This controlling madness has to stop.

      Reply
  9. Gary

    I only wish Americans had not become such total sheep. Skepticism in the U.S. has gone the way of the gooney bird. Bless you brave doctors in the U.K. for standing up for what is right, standing up to money.

    Reply
    1. Vic

      Sadly, here in the U.S. most people are in awe of “Doctor.” My Dad was dying of congestive heart failure, on hospice with just a few months to live. He was horribly weak, had skin lesions and dementia. He was seeing 2 Drs and the hospice nurses/PAs. I asked each and every one of them if we could take him off the statins. Every single one looked at me like I had two heads and they all replied that he needed them. I asked why. The reply was always “We need to keep those numbers down.” I asked that since he didn’t have any blockage, even presuming that high number would result in blockage, just how long would it take for that blockage to occur? The response? “Why take the chance?” Since my Mom is still very much alert and capable, I had to let her decide. Dad took them til the day he died. Would he have lived without them, no, but I will bet he would have been more able to enjoy the time he had left.

      Reply
      1. mikecawdery

        Dement Geriatr Cogn Disord 2009;28:75–80
        DOI: 10.1159/000231980 Can be downloaded in full.
        Midlife Serum Cholesterol and Increased Risk of Alzheimer’s and Vascular Dementia Three Decades Later
        Alina Solomon et al.

        I came across this paper first on the WebMD site in 2009. Not properly referenced therein and I enquired from both WebMD and WebMD-BOOTS (UK version) about this use of statins and my comments Both declined to answer.

        From the full paper, the following extracts are very pertinent:

        Extract from Introduction:

        Thus, the best approach implies not only early diagnosis and treatment, but also emphasizes prevention. However, chronic diseases with a long preclinical phase (such as AD) pose inherent difficulties in the identification of their risk factors. Since disease onset cannot be pinpointed, the chances are that true risk relationships (factors increasing the probability of getting the disease) and reverse causality (the effects of the disease itself on various factors) get confused.

        Comment: Indeed and three decades use of drugs, with an acknowledged adverse reaction of polyneuropathy and other neurological adverse reactions is ignored as a factor in the development of Alzheimer’s. Now that takes some bias.

        Extract from Strengths and Limitations of the Study

        Information on lipid lowering treatments, which have been suggested to decrease dementia risk , was not available for this study.

        Comment: The patient records were available for many possible factors such as age, sex, race, education and other medical conditions (Table 1) but not the therapeutic records. This is unbelievable; patient records without treatment details implies either gross incompetence or negligence or that the records were withheld DELIBERATELY for the purpose of obfuscation and protection of Big Pharma profits.

        I therefore did a quick 2×2 Chi-square test using Table 2 of the paper using both the combined and separately the AD and VaD numbers using guidelines on therapy, i.e. cholesterol blood levels over 200 and over 239 mg/dl should be treated with statins while cholesterol levels less than 200 mg/dl would not usually be treated. As the results were significant it is quite clear why the data on therapy was NOT available; Big Pharma would certainly not approve of results that implicated statins as a possible cause of Alzheimer’s and VaD

        Download the paper and then replace cholesterol levels in the Tables (2-4) row titles with guideline treatment. This does not change numbers or stats but certainly provides an alternative interpretation.

      2. mikecawdery

        The comment was very abbreviated – difficult to send tables in wordpress which would clarify.

        I can send you the paper and my detailed comments as a pdf file(s) should you want them but it would have to be an email address.

  10. amieres

    Is the data on those pre-trial run-in periods kept & reported? It seems to me that is the most important data for determining who should never be prescribed statins in the first place. If adverse effects can be found so early in a study that group should be of primary importance for further study. Do we even know what percentage this group represents?

    Reply
    1. mikecawdery

      I suggested to NICE that they should use the HPS inclusion/exclusion criteria if they seriously wanted to reduce the number of adverse reactions. Totally ignored but such measures would reduce statin sales and that WOULD NOT PLEASE Big Pharma or its KOLs

      Reply
    2. celia

      I’m afraid I suspect I already know the answer to that one. Goodness, if they kept that someone might find it, and then how could the drug companies market their lovely profit making drugs?

      Reply
  11. Susan

    Interesting question, that. In Prof Rory Collins own Heart Protection Study of 2002, they started with about 32,000 possible subjects. They then weeded out more than a third of them (12,000) who couldn’t tolerate the statins. Does “couldn’t tolerate” = “adverse effects”? That right there sounds like a pretty high percentage (37.5%) of adverse effects to me.

    Reply
  12. Felonious Grammar

    Two of my main complaints about the Veteran’s Administration is that they prescribe drugs that their own studies have shown to have no benefit for PTSD, and its dedication to “preventive” medicine based only on lab numbers. As everyone here knows, many of those numbers have no more scientific validity than a recipe for fried ice cream; and the “preventive” treatments can be much more harmful than eating fried ice cream.

    The V.A. always recognizes a patient’s right to refuse medication, even in the psyche ward; but I adore my primary care physician, knows she’s pressured to use the guidelines, and know that she really does care about my health. So, I took a statin until the blood tests were done, while doing my own research. (Which is how I found Dr, Kendrick.) And now I’m working on a report to break it to her medically and personally, with far fewer words than this comment.

    I am at risk for heart attack and stroke, but I don’t have a heart condition right now, and I am not willing to take the risks of permanent muscle cramp and joint pain that could mistakenly be identified as worsening of MS. To risk that in order to possibly be 1 of the 500 NNT with statins to gain substantial benefit? That’s just nuts. I concede that it has taken a hell of a lot of time and study for me to discover these things myself, learn their significance, and to design and carry out a plan— I only have two persons’ health to be concerned about.

    I’m taking a break from preparing my report for my neurologist right now. He will put it in my records for future reference. My neurologists have been convinced that my GP is supposed to take care of the pain medication, and my GP has been convinced that my neurologists are, but I got this.

    I’ve also been discontinuing medications (very carefully) that are unnecessary now that I’ve discovered that all the MS pain above my ankles was caused by night sweats and night flashes. Hormone replacement has provided the best drug benefits I’ve ever experienced.

    So, I’m down to the quick cutting down on baclofen— an antispasmodic that can cause psychosis if stopped abruptly— and that has now proven itself to be the CAUSE of most of the spasm, muscle rigidity, and pain in my feet and ankles the last three years. Icy Hot works better and more immediately than baclofen, oxy, and ibuprofen combined. Am also discontinuing oxycodone and cutting down on the ibuprofen. I’m also looking forward to the experience of pooping naturally. Even the laxatives are causing constipation.

    Finding out that I’m just not really as sick, riddled with chronic pain, or degenerating into a near stupor so stuporous that it makes it difficult for me to read is about the sweetest thing I’ve ever stumbled onto. I learned the same lessons from psychiatrists and their drugs— a decade of toxic rotating cocktails for my “treatment resistant” reaction to an antidepressant— for what was initially an iron deficiency and the effects of the drugs. Now I know. I guess being struck by a scientifically valid disease threw me off.

    Carry on, please— it’s a difficult battle and the other side may have bigger pockets than armaments industries, but the amount of benefit and relief that could be had just by not taking some medication(s) and the harm that could be prevented would be more huge for the whole human race than anything could measure accurately— it’s invaluable. Priceless.

    And sometimes, some medications do work like nothing else will for some conditions for some people, and that’s priceless, too. There’s no reasonable reason for us not to have the best of both worlds when we can, while accepting reasonable and unknown risks. I’ve made it a policy not to take anything that is still under patent for a long time, but surely drugs can be better tested under better conditions that they have been, and longitudinal studies should be the rule.

    Thank you, Dr, Kendrick for talking back statins, and such.

    Reply
  13. Professor Göran Sjöberg

    Malcolm,

    Thank you for continuously fighting!

    First, you get interested in the subject of statins and most probably because you have got a problem with the subject and as for me through a seriously damaged heart since 15 years. Then I did my reasonable homework, as a researcher within the natural sciences, and arrived at doing exactly the opposite to what the medical professionals recommended me to do.

    No medicines, no by-pass but out with the transfats harbouring in the margarines, all sweets causing low grade inflammation and adding some natural supplements and – Eureka! – with time regaining my health.

    Where do you then arrive?

    It’s simple!

    At a complete mistrust in medicine as being a part of what I, as a metallurgist, would call the natural sciences.

    Medicine is to me, today, a scam religion!

    The only way they would get me to take a statin would be by force feeding.

    Reply
    1. mikecawdery

      Einstein said that an elegant theory could be completely refuted by one inconvenient contradictory fact. In the case of cholesterol and atherosclerosis, there is a cornucopia of such facts.

      Dr. Ernest N. Curtis, M.D.

      HOW VERY TRUE BUT IT DOES NOT SEEM TO APPLY WITH THE MEDICAL ESTABLISHMENT!

      Reply
  14. Sue Richardson

    It is an absolute disgrace to hear that the people who allegedly care for our health (NICE) could side line the concerns expressed in your letter to them. It takes any confidence in them away altogether, if ever one had any that is. On the other hand I was pleased to read in your blog that GPs are at last beginning to question the use of statins and the pharma industry. I hope they chat amongst themselves until this questioning gets louder and NICE is forced to listen.

    Reply
      1. Gary

        I believe signer is correct. Signee doesn’t appear to be a word. But we love you anyway!

      2. dearieme

        I dislike being told I’m an attendee at a conference; where, I demand, are the people attending to me?

  15. GG

    Medicalisation of healthy people is not in the interest of the people concerned nor is it in the interest of the NHS but it is in the interest of Big Pharma. Birth and death have been medicalised and now they want ‘life’ medicalised. We are not allowed to just die when we get to the end of our life. We have to die of some medical condition. Now they want our life medicalised too. For those silly enough to follow such advice will probably see their future life as one long round of regular trips to see their doctor for conditions that only exist as adverse effects because their life has been medicalised. How could anyone argue in favour of this crazy plan (Big Pharma excepted)? Where will it all stop?

    Reply
    1. Jennifer

      Absolutely SPOT ON. (Oh dear, there is bound to be a chemical concoction for the spots.) I couldn’t agree more with GG.

      Reply
      1. Wendy Drane

        I am writing to amend a statement I made in a previous reply. I said my brother developed a permanent myopathy after 2 weeks on statins. I have just spoken to him and he said it was in fact 5 or 6 weeks. Still a very short period but not quite as short as I stated . I would not wish to mislead. It doesn’t change the facts that the statins had a devastating effect that changed his life forever.

  16. Ash Simmonds

    I enjoyed this circular logic from Kresser a while back:

    “Some have expressed concern that introducing [LDL particle number] into clinical practice will result in confusion to both physicians and patients, and that the public may lose confidence in the healthcare system if cholesterol, which has been emphasized for decades, is challenged as the primary means of risk assessment.”

    “So essentially they’re saying that some doctors are worried that if we tell you the truth, you’re not going to trust the medical system because we’ve been telling you something that’s not true for decades as a kind of justification for not telling the truth, which is just mindboggling to me. It’s absolutely crazy. I mean, I think they’re right.”

    –> http://chriskresser.com/thoughts-on-paleofantasy-bpa-toxicity-research-and-book-updates

    I guess it’s better to be wrong and trusted than right and suss.

    Reply

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