How do statin proponents deal with debate? They stifle it.

Last month, one of my blog posts featured a letter written by a group of doctors, expressing their concerns about the mooted expansion of statin therapy. The letter detailed six major objections to the plan, including the mass-medicalization of millions of healthy individuals, the unreliability of the evidence regarding the adverse effects of statins, and the facts that almost all the evidence is industry-funded and that multiple conflicts of interest exist on the ‘expert committee’ that is adjudicating on the statin issue. The letter received widespread coverage in the press and other media, and I think it did much to stoke the flaming debate that some have described as the ‘statin wars’.

Those strongly supportive of the plans to widen statin prescriptions are hardly going to go away without a fight, though. And this week six professors convened a press briefing at the Science Media Centre to put forward their arguments. The briefing was reported in the British Medical Journal this week [1].

Two of the ‘usual suspects’ were Professor Sir Rory Collins (head of the Cholesterol Treatment Trialists collaboration) and Professor Peter Weissberg (medical director of the British Heart Foundation).

One of Professor Collins’ gripes was, apparently, that “misrepresenting the evidence” will have a negative impact on people who are at high risk of cardiac events. He is quoted as saying: “It’s perfectly reasonable to debate whether patients at lower risk should get statins or not, but it’s inappropriate to misrepresent the evidence.”

He redoubled his assertion that rates of ‘myopathy’ are much lower than some people state. However, he is referring to the incidence of muscle problems where the threshold of ‘abnormal’ is when levels of the enzyme used to assess muscle damage (creatinine kinase) is at least 10 times the upper limit of normal. Professor Sir Rory Collins is apparently disinterested unless muscles are in near-meltdown. We can, I suppose, just ignore those poor unfortunates with less biochemical aberrations even though their symptoms are real and often debilitating. I think it’s clearly business as usual for Rory Collins, who makes claims that some are misleading the public while I think he, ahem, continues to mislead the public.

Professor Weissberg tells us that the “…the critics are wrong. They’ve retracted, they’re wrong.” Except, that the only thing that has been retracted were the misleading representations of statin side-effects as reported in one piece of research. All the major objections detailed in the original letter stand until someone properly disputes them.

With regard to these, Professor Weissberg calms any concerns about industry involvement in the evidence base, because drug companies only paid people to do the studies, rather than the drug companies doing the studies themselves. So, nothing to concern ourselves with here.

He adds that: “The biggest threat to good medicine is prejudice and anecdote.” I have some sympathy for this view, but boy would I like to see Professor Weissberg stay away from prejudice and anecdote myself. It was not so long ago that he made claims to support statins using data that did not support the use of statins at all.

And perhaps the most telling thing of all are the comments that come from Fiona Fox, director of the Science Media Centre. Apparently, only pro-statin experts were invited to the briefing. In defence of this tactic, Ms Fox tells us that the “vast majority” of cardiac and statin experts believed that the evidence was overwhelming, and that it was not the centre’s job to provide a platform to a minority who did not and thereby project a false image that the debate was in equipoise (when it was not).

First of all, I wouldn’t be too sure that the evidence is overwhelming or that the pro-statin camp is in the great majority.  And even if there things were true, is that a reason to stifle debate and allow no right of reply?

Do these tactics suggest that Professors Collins and Weissberg and the rest of their merry band of men have true confidence in their position? I personally doubt it, and believe that their attempt to shut down debate suggests they may be desperate not to have the weakness of the data and their arguments revealed in front of their very own eyes.

References:

1. Hawkes N, et al. Six professors back NICE guidance on extending use of statins. BMJ 2014;349:g4380

 

21 Responses to How do statin proponents deal with debate? They stifle it.

  1. Mark John 4 July 2014 at 3:39 pm #

    Thirty years ago, all the experts knew stomach ulcers were caused by excess acid in the stomach and that no living organism could live in such an acidic environment. Only two doctors, Warren and Marshall challenged that idea by claiming it was bacteria and not acid.

    It turned out that the two doctors were right (with a Nobel Prize to prove it) and the rest of the medical establishment were wrong. And the H. pylori bacteria were far cleverer than the scientists at the time who proclaimed that bacteria couldn’t exist in stomach acid – the H Pylori simply produce ammonia to neutralize the area around them.

    History just repeats itself…

  2. robert 4 July 2014 at 5:08 pm #

    A whole nation held hostage by a few obsessed grumpy old men, chasing after their pot of gold at the end of the rainbow. Those in power don’t seem to mind at all. Very telling.

  3. Stephen Rhodes 4 July 2014 at 5:30 pm #

    From the Comment is Free section of the Guardian Newspaper’s website today.
    The comment is in response to a piece that again highlights the lack of funding for necessary transformative changes in the NHS.

    “There appears to be a consensus that the NHS is in need of additional resources to transform the service provided to the public.

    May I make a plea to all concerned to take a long hard look at the use of statin drugs and the costs the NHS bears from their continued use, and the sums that would be liberated for use elsewhere in the NHS from stopping their use.

    Without going into long arguments over whether the basis for prescribing this drug – to reduce cholesterol levels – is valid or not, those trials that are available for public scrutiny amply demonstrate that taking statins has no effect on ‘all cause’ mortality.

    What this means is that the money spent on statins by the NHS gives no benefit to the cohort of patients taking them, they die at the same rate, just from a different set of causes, and crucially, the ‘number needed to treat’ (NNT) to achieve this re-arranging of the deckchairs is very large and takes very significant resources from other areas of the NHS where far greater patient benefits would accrue.

    As patients taking statins are dying at the same rate, and since CVD and stroke are less common causes of death as a result, then it is clear that statins are causing increased numbers of deaths from the ‘side effects’ denied by Rory Collins.

    Since a number of these side effects are conditions like diabetes that already cost the NHS billions, stopping mass medication with statins will save even more very large sums that can then be spent on the necessary transformation of NHS care.”

    • Jennifer 5 July 2014 at 11:37 am #

      Reply to Stephen Rhodes.
      So true!
      I must have saved the NHS £1000s by stopping all repeat prescriptions, by not having interminable tests, and ceasing to take up surgery time, because I am utterly healthy now.
      Imagine these savings million-fold across the nation. Little wonder there is not enough in the coffers for those in real need. But real conditions take serious time and expertise to manage….it is so much easier to deal with the worried well who are terrified at not complying. The really ill are hardly in a position to shout very loud, and the wonderful NHS staff are too busy and tired to make much impact with the powers that be, who appear to mindlessly adhere to those with the loudest voices.
      Who said “he who shouts loudest, takes his brother’s share”?
      And it goes without saying, “those with the biggest pockets, have the loudest voices!” Ref: Jennifer 2014.

  4. Hedley Paul 4 July 2014 at 5:55 pm #

    My mother and three step mothers (yes three) were ALL advised while pregnant to ‘”smoke cigarettes – it will make for an easier birth”. That was the received wisdom – unbelieveable now, but actually totally true… Starve the embryo of oxygen, stunt its growth, ergo an easier birth. Now regarded as lunacy – THIS WAS THE ADVICE OF ESTABLISHMENT DOCTORS!
    Weed out the sheep from the NHS, then train (and allow) doctors to actually THINK for themselves instead of following the ‘BIG PHARMA’ diktat and so very many modern ailments would disappear.

    • Janet B 5 July 2014 at 1:49 am #

      And my grandmother, insulin dependent, was advised to smoke cigarettes to ease hunger pangs. As I remember she tried hard with Du Maurrier and couldn’t bear them ( but I, as a small child, was charmed by the pretty red box they came in)

  5. Brian 4 July 2014 at 6:35 pm #

    John

    Have just read the book

    How Statin Drugs Really Lower Cholesterol: And Kill You One Cell at a Time
    By James B. and Hannah Yoseph

    The EVIDENCE is overwhelming that statins should be banned and those responsible for foisting them on the world prosecuted for mass murder and GBH.

    How come you are not going after them (using the FACTS from the records) like an attack dog.

    • Moy Peralta 5 July 2014 at 3:18 pm #

      Dr Briffa’s recent polemics are – as always – timely, sane, and most welcome to see in print. Whilst we are all being medically ‘treated’ for a wave of diabetes… a wave of Altheimer’s… and sudden mysteriously-escalating epidemics of everything else…. where will it all end!

      If not too tangential, I would like to pick up here on Brian’s comments, which are refreshingly more direct than usually seen.

      I ask just how many patients is a doctor permitted to kill, maim or otherwise seriously harm before investigation takes place? If levels of harm result from what is currently considered “good professional practice”, i.e. government guidelines, NO investigation into avoidable deaths is ever deemed necessary, least of all by the GMC.

      Adverse, sometimes fatal, drug effects (‘Drug Traffic Accidents’, as RxISK terms them) are seldom if ever reported, as a GP’s response to feedback is generally denial – denial that such consequences can stem from their prescribed drug. How unprofessional, wilful, stubborn, or unbelievably ignorant are these denials. As carer for my husband, who believed he had to take his indoctrinated doctor’s advice, I, like thousands of others, live with the daily consequence of, not blunders, but a wilful, stubbornness from my adamant, fixed-thinking GP.

      To pick up on Brian’s 4th July comment that those responsible for foisting poisons on us be prosecuted…

      There is a time limit after which no action can be taken.

      There is a tripwire, after which you will not succeed.

      And no doctor will ever be suspended or prosecuted for following current medical ideology.

      Nice stitch-ups for those of us coping with bereavement from death-by-doctor. (In the current profitable drug climate, victims are merely written off. My mother was one, and my husband has all but become another.)

      Perhaps we should start our own Register of Avoidable Deaths.

      For those who may be interested, I wd recommend chapter 38 of Gerard Kielty’s book Why Doctors Don’t Make You Healthy, which walks us grimly through the rigmarole – he calls it pantomime – of attempting to sue a doctor. I have no reason to believe that Mr Kielty’s presentation of this thwarted endeavour is not accurate.

  6. robert 4 July 2014 at 6:41 pm #

    “…and so very many modern ailments would disappear.”

    And herein lies part of the problem. Good for us, bad for them.

  7. Lorna 4 July 2014 at 10:00 pm #

    Dare I suggest that here in the UK the continued growth of vested interest and bias in medical issues is a consequence of de-regulation and privatisation of our health system? Where is the neutral expert to be found in the medical marketplace where everyone has something to sell?

  8. Vince 4 July 2014 at 10:03 pm #

    And don’t forget the collateral damage of cholesterol and statin fixation. i.e eyes averted from the main game in vascular disease.To wit, Metabolic dysregulation with the continuum of carbohydrate intolerance/insulin resistance/pre diabetes and then overt T2DM. I have lost count of the number of my patients with these important and quite readily reversible dilemmas fresh from their CABG and Stents and all I get back from the cardiologists are the usual pleas that I keep a close eye on cholesterol levels.
    One in three UK folks pre diabetic. Ditto for the USA with a recent numerical figure of 86 million there. No figures for us downunder as yet, but I know where my money would be. Widening statin use will certainly aggravate these figures, and yet again contribute to even more distraction from THE main cause of vascular disease. Remember those strange “doctors” out there advocating having a statin along with your high carb fast food ? Do whatever you like and take this and you will be right. This doctoring game is getting curiouser and curiouser.

    • Christopher Palmer 5 July 2014 at 6:02 am #

      Mass-hysteric-lipophobia (everybody is afraid to eat fat – based upon presumption and not fact(s)) has been hugely detrimental to public health.

    • M. Cawdery 5 July 2014 at 5:29 pm #

      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 incompetece 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. The results are shown below in the table. 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

      PMID: 16866914 [PubMed - indexed for MEDLINE]

      Table Showing 2 x 2 analysis (CSS) for combined AD and VaD and assuming TC values above 239 mg/dl as treated with statins. Given guidelines this is almost certain.
      Cholesterol categories No dementia %age AD & VaD %age TOTAL %age
      NO TREAT (239 mg/dl) 2932 50.31 215 3.69 3147 54.00

      Totals 5477 93.98 351 6.02 5828 100

      CHI2 = 7.92 p= 0.0049
      V2 = 7.91 p= 0.0049
      Phi2 = p = 0.0014

      This is highly significant and the fact that the actual therapies used were “unavailable” suggests doubtful, if not corrupt, practice and bias. The Relative Rate (RR – much loved by medical statisticians) is a 58% INCREASE associated with the recommended prescription for statins. (The therapy recommendations for high cholesterol are based on US guidelines http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3xsum.pdf)

      No wonder this paper is very rarely cited by those claiming that statins ameliorate, moderate or reduce signs and symptoms of AD.

  9. Soul 5 July 2014 at 1:27 am #

    When reading about the history of heart disease and cholesterol management, it’s amazing at how the cholesterol theory took hold of the western health care industry and the general pubic overall. Of course now statin promoters are wanting to move beyond the original base of lipid control, to simply promote their product for broader use, sadly.

    There are many different theories on what cause heart disease. There are numerous other ideas that can be employed for preventing a cardiac outside of statins and cholesterol testing, ideas that are likely to be more helpful it seems to me. Yet, all to often there seems to be little interest in promoting these ideas further, by many.

    It will be interesting to see who comes out on top in the statin wars. The internet can be a game changer with these kinds of things. I wonder if something else concerning heart disease prevention can and will take hold of the publics imagination.

    The other week I read snippets of historian Nialls Furguson article about networks and hierachies. It reminded me a bit of your and others writings Dr Briffa about how the current statin debate is in part being handled.

    “Networks Vs. Hierarchies: Which Will Win?”

    http://www.zerohedge.com/news/2014-06-27/networks-vs-hierarchies-which-will-win

  10. M. Cawdery 5 July 2014 at 10:17 am #

    One of Professor Collins’ gripes was, apparently, that “misrepresenting the evidence”

    Wow! And this is the man who used a highly selected tolerant statin group (excluding intolerents, potential intolerants, non-compliants (undefined – ? Statin adverse reaction sufferers) to claim a very low incidence of adverse reactions..0
    He is also the lead author of the HPS study which included the words “heart protection” and “cholesterol lowering” in the title but nowhere in the report was cholesterol lowering per se (rather than the several pleiotropic actions of statins) demonstrated to be responsible.

    Indeed, there were two main treatments groups in the study with three sub-groups in each group, namely

    1. The no event group
    2. The non-fatal group and
    3. The fatal group

    These three groups are identifiable and, assuming the cholesterol hypothesis is correct then it can be assumed that the mean cholesterol levels would be in the following order:

    The no event group < The non-fatal group < The fatal group respectively in both treatment groups.

    Having the data, this is a relatively simple two way ANOVAR.

    Personally I cannot conceive that a competent researcher would ignore this, given the title. I did email the CTU requesting many years ago but was ignored.

    I conclude that the analysis was done but the results did not support the cholesterol hypothesis so were dumped; something that regularly happens in Phase 3 infomercial studies of this type.

    Of course, given the results (and data) of this analysis I am more than willing to retract if the data itself is made available! (Which it won’t be)

    • O 11 July 2014 at 4:03 pm #

      Every time I meet a research scientist they say this:

      “Doctors are not scientists”

      And research like this explains why.

  11. Soul 10 July 2014 at 2:06 am #

    You likely have already heard of this, but if not – in America we’re one of the few countries where drugs are advertise on TV. We also see a good many TV commercials with attorneys trying to build cases, often to bring class action law suites on all kinds of topics, with health being a top item discussed.

    One newer TV commercial, at least new to me, concerns a law firm looking to bring suite against the makers of Lipitor. The commercial warns that Lipitor can sometimes bring about type 2 diabetes in women. The law firms web sight can be seen at:

    http://www.parilmanlaw.com/dangerous-drugs/lipitor-side-effects/

  12. Lorna 11 July 2014 at 2:06 pm #

    Good to see statin damage being taken up legally in the US. It’s interesting that the legal firm accept the ‘need’ for medication to lower cholesterol though. Would be even better if there was concerted efforts by legal firms to challenge the market use of faulty claims in the original hypothesis which deceitfully sell damaging drugs in the first place.

    • Christopher Palmer 11 July 2014 at 7:00 pm #

      Well said Lorna, certain oxides of cholesterol have been proven to be so much more atherogenic than has cholesterol itself, and within much the same body of work pure cholesterol, free from cholesterol oxide impurities, has been exonerated from having any atherogenic or carcinogenic properties whatsoever.

  13. tal 11 July 2014 at 9:49 pm #

    Here’s an interesting article from The Oxford Journal (no longer available at their site):

    The great cholesterol myth; unfortunate consequences of Brown and Goldstein’s mistake

    https://web.archive.org/web/20131207062903/http://qjmed.oxfordjournals.org/content/104/10/867.full

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