The serious trust deficiency afflicting medical advice and what to do about it

By Jerome Burne

Trust me I’m a doctor has become a knowing, cynical catch-phrase but the underlying truth is that we do need to trust our doctors, not only because trusted doctors exert a beneficial healing effect but also because we are entrusting them with something precious – our health.

Several recent events however suggest that we would do well to keep our cynical streak on high alert when visiting. Unquestioning trust can have dangerous consequences, as some patients taking statins have found along with those with ME/CFS.

A reasonable summary of a recent HIUK post about statins would be: ‘You can’t trust claims about statins because they are based on secret data’. While a summary of last week’s post might be: ‘You can’t trust claims about the benefits of psychological treatment for ME/CFS because they have been wildly exaggerated’. Not only that but the authorities involved fought hard and expensively to prevent the facts emerging.

I do think there may be a way out of this long-running conflict between patients and authorities which I will come to later but what happened initially in the wake of these two posts caused my trustometer to plunge even lower.

Impenetrable mathematical wizardry

First was a post on another blog which explained that a trial of the great and good Mediterranean diet had arrived at its impressive conclusion with the aid of the sort of impenetrable statistical workings that has given a shine to statins. I knew that a similar form of mathematical wizardry had created things called ‘collateralised debt obligations’ that set off the banking crash but I’d never actually seen one at work.

Now I have and this is what it looks like:

We calculated PAF [Population Attributable Fraction] based on the formula of rate difference: PAF = (I0 − Ii)/I0, equivalent to I0 − HR × dMDS/I0, where HR was estimated continuously with adjustment for potential confounders as aforementioned, I0 is observed incidence per 10,000 person-years, and Ii represents a hypothetical, ideal incidence if the population achieved high MDS (95th percentile) (dMDS=MDSideal – MDSobserved). The CI of the PAF was derived from bootstrapping to estimate HR and PAF iteratively (n resampling = 100, after confirming no difference in results between n = 100 and 1000).”

Remarkable isn’t it? This one was found in a large nutrition trial published last week extolling the benefits of the Mediterranean diet.  I’m prepared to bet that no more than a handful of BMJ or Lancet readers could assess whether the answer it produced was right or wrong or how the conclusion was arrived at. You just have to take it on trust.

It might be described as a “statistical McGuffin” (A McGuffin is a term used in movie circles to describe something that propels the plot without having any further function.) Its purpose in the trial was to produce a result that would generate the impressive headline: ‘Mediterranean Diet could prevent 20,000 heart disease deaths per year.’

What you need to know about McGufIins

I’m grateful to the indefatigable Dr Zoe Harcombe, a hugely well-informed nutritionist with a clear grip on bio-medical statistics, for this explanation. She cheerfully admitted she didn’t understand the workings of this particular McGuffin, but that didn’t matter. She knew what its underlying assumptions were and what it was designed to do.

Its purpose was to translate the key finding of the research –that following the diet closely made you less likely to die from a heart attack – into the number of lives that would save in the UK as a whole.

The problem isn’t with the mathematical processes but, as with the financial statistical McGuffins, with the assumptions it was set to work on. Firstly, that the result of a study of a 24,000 people with an average age of 59 would be directly applicable to people of the average age in the UK which is 40. Secondly that 12.5% of the total number of heart attack deaths could be prevented with the diet. As Dr Harcombe explains there are good reasons why both are unfounded.

Without independent and informed experts like her, national dietary policy and drug guidelines can presented as objective and scientific when they are actually based on questionable assumptions.

Patients take unusual steps

But there is no need to reach for a McGuffin to give statistics a highly misleading spin. A quick change to the criteria for success can also do it effectively. This move was central to last week’s blog about the remarkable events in the world of ME/CFS where the issue of how best to treat patients is bitterly contested.

For those starting here the story centred round a standard clinical trial that, five years ago, had found that the official treatment –psychotherapy and graded exercise – was effective in improving many patients’ lives and helping a significant number to recover.

When it was published something unusual happened. Not only did a considerable number of patients not believe the results but they wrote letters and compiled reports setting out their reasons and demanding to see the original data. Last month five years of campaigning produced two totally unexpected results. The psychologists who ran the trial were forced to release the data and when it was analysed the patients concerns appeared justified.

What triggered a further drop in my trustometer was the response to this bombshell. Serious questions had been raised about the accuracy of the data underpinning a NICE approved treatment which affects around 200,000 patients. And nothing happened. No TV coverage, no headlines just an uneasy silence like a car crash in slow motion.

The curve ball here was that the re-analysis had been driven by the patients rather than the regulator. That’s unheard of, although there is no reason why the results shouldn’t be correct. In fact there is obviously a case for involving patients in any such re-assessment. They are certainly stakeholders in the business here and I describe a way it might happen below.

Nothing to do with me guv.

The BMJ covered this dramatic story in a misleadingly low-key way. It didn’t spell out the long campaign to get the data or convey how damning was the dismissal of the reasons given for not releasing the data. This was especially curious because the journal has been campaigning for the release of hidden statin data for at least two years. Surely a patient’s successful use of Freedom of Information could have been hailed as a significant victory and maybe a strategy to try?

The Guardian was the only national paper to cover it but it didn’t even attempt to set out the details or provide any context. Instead of dishing out the forensic treatment given to wealthy tax dodgers or regulation busting banks, it handed over half a page to the lead author of the disputed trial to explain how hard he worked to help patients – most likely true –but which he followed with a curious use of the passive tense:

‘There are claims of foul play,’ he wrote ‘with issues over freedom of information and sharing of trial data.’ The fact that he is one of the central figures in these issues doesn’t really come across. It would certainly leave the casual reader no wiser as to what had been happening.

What this limited and downbeat response highlighted was that once a treatment is out there approved and being used, it is virtually impossible to get any kind of reassessment until people start dying as with Vioxx. And that even evidence based critiques are unwelcome.

Cholesterol data fiddling goes back a long way

Resisting any kind of challenge and dismissing critics is also the way the current statin debate has been handled. What I hadn’t appreciated until I started reading a remarkable new book this week, was just how far back the fiddling of statin data and refusal to engage with critics goes.

It has one of those does-what-it-says-on-the-tin titles: ‘Fat And Cholesterol Don’t Cause Heart Attacks And Statins Are Not The Solution’ and contains contributions from 22 leading clinical and academic critics of the widespread use of these drugs.

It builds a detailed case for the way evidence has long been ignored or twisted, detailing, for example, the early shenanigans around the long running Framingham study investigating the links between diet and heart disease. One influential paper claimed that for every 1% reduction in cholesterol there was a 2% reduction in the risk of heart disease. This was seriously misleading. Years later when the study was re-examined it emerged that the study had actually found that for every 1% drop in cholesterol there was an 11% increase in coronary and other causes of death.

The book details other long, large scale trials such as MRFIT (Multiple Risk Factor Intervention Trial) and WHI (Women’s Health Initiative) both of which found that a drop in cholesterol had no effect on CHD. There’s a description of a randomised controlled trial of a cholesterol lowering drug called Cholestryramine, which claimed to have found the same 1% reduction leading to a 2% reduction in CHD events. Again, a subsequent review found no difference between the placebo and drug groups. 

Critics warned off having a meeting

But the failed trials were not enough to counter the major PR offensives against cholesterol and the facts about the unreliable ones came out later. Persistent and informed critics were ruthlessly treated. One of these was George Mann, a professor of Medicine and Biochemistry who had done research in 1960 which failed to find a link between lower cholesterol and heart disease rates, which was never published at the time.

When he attempted to organise a conference to discuss flaws in the cholesterol hypothesis only 12 delegates turned up. The rest had been either fooled by false announcements saying it had been cancelled or warned their funding would be cancelled if they attended.

A big difference between then and now is the internet, which makes it far harder to stifle criticism as both ‘Statins Are Not The Solution’ and the ME/CFS re-analysis shows. The opportunities it throws up are leading to more formal involvement by cancer patients, for example, in their treatment under the mantra: ‘Nothing about us without us’. This could be expanded to other diseases.

Patient representatives have long had a place on committees run by companies and organisations but the latest idea, dubbed ‘evidence based advocacy’, is that they should be more involved, informed and proactive. The sorts of things being suggested include ‘conducting online surveys though software such as Survey Monkey, gathering opinions at conferences and conducting Facebook polls.’ Might some such formal feedback system have made action on the demands of ME/CFS patient less of a frustrating battle for both sides?

One organisation called Europa Donna, which involves breast cancer patients, is now being asked to serve on the committees that run clinical trials. Since these can involve highly technical decisions, Europa Donna is providing training, particularly in the research field. ‘The result,’ a spokesperson is quoted as saying ‘is they can do an effective job and not just rubber-stamp what is handed to them by the scientific investigators.’

Is it wildly optimistic to imagine patients sitting across a table from researchers discussing the release of the full data on statins- maybe some had been in the original trials – or making informed critiques of the trial of a new treatment for ME/CFS. Certainly something needs to change.

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

26 Comments

  • “One influential paper claimed that for every 1% reduction in cholesterol there was a 2% reduction in the risk of heart disease. This was seriously misleading. Years later when the study was re-examined it emerged that the study had actually found that for every 1% drop in cholesterol there was an 11% increase in coronary and other causes of death”.

    Stunning and appalling. Thank you very much indeed for this excellent and very useful post.

  • Dr Kendrick and others often complain of the criticism they receive, along the lines of, “By opposing statins you are killing X thousand people”.

    Yet it is in fact doctors and scientists like the authors of the paper you cite who do that. Seriously, the courts hand out life sentences to someone who deliberately or knowingly kills a single fellow human being. Shouldn’t there be some legal sanction against giving advice that reduces the life expectancy of thousands (or even millions) in exchange for money or power?

    • Well said, tom.

      Manipulating and withholding data should be a criminal offence. NICE should have a presumption of refusal unless they can see alll data and make it available to respectable outside bodies. They’ll never stop being greedy, but we can make them wary by providing a good chance of dishonesty being exposed. Penalties should then be eye-watering. Transparency is a big part of the answer.

  • yes there is: depraved indifference

  • Jerome, thank you for being one of the few who pays any attention to ME.

    You may be interested in looking at the proposed MEGA (M.E./CFS Epidemiology and Genomics Alliance) study. They recently released a petition to gather patient support (https://www.change.org/p/support-this-huge-biomedical-m-e-cfs-study-and-its-application-to-major-uk-research-funders), something that, on face value, should have been guaranteed as the patient population are desperate for biomedical research.

    Sadly it has hit a wave of patient criticism, not least for including the lead author of the PACE study, Peter White, as well as a number of other researchers who share his psychosocial belief of ME, and who are there as the so-called “ME experts”. Peter White has now moved back to ‘merely’ being an advisor but for a lot of patients, the distrust that has built up over the years due to the ‘irregularities’ with the PACE trial means their presence in the study is a huge obstacle in the way of patients supporting the study.

    You say “Is it wildly optimistic to imagine patients sitting across a table from researchers discussing the release of the full data on statins- maybe some had been in the original trials – or making informed critiques of the trial of a new treatment for ME/CFS. Certainly something needs to change.”. Sadly, MEGA is proving this point again, as the MEGA group seemed to be shocked by the overall patient response, something which, if they had engaged with us prior to the petition, they potentially could have avoided.

    • Editorial

      I confess to having no real knowledge of the practicalities of patient advocacy – there is obviously a considerable number of ME/CFS patients who are very well-informed about their condition so has there ever been any attempt to involve them in setting research priorities, developing guidelines etc? I can imagine all sorts of pitfalls but it is remarkable the the researchers feel the need to run a consultation to find out what patients want from research. It took me a couple of days over a decade ago to become aware of how desperately they wanted serious acknowledgement that they had a biomedical disorder, its pretty clear that today nothing has changed.

      • Short answer, no, they haven’t. Especially since the PACE ‘results’ first came out the authorities in this country have tried their best to keep the main patient opinion as quiet as possible, in particularly through the use of the story line of militant patients making threats towards researchers which is still being put about today (despite this argument being thrown out by the recent FOI tribunal – the best evidence that the PACE authors gave was that somebody once was heckled at a conference..).

        The MEGA group are making noises about involving patients but we haven’t seen any evidence of that so far. The petition they have raised isn’t even an attempt to consult about what patients want from the research, they merely want names on a bit of paper to be able to add to their study application so as to show how much patient support they have. The problem for many informed patients is that we are determined not to have a PACE-like situation on our hands again, where ME research in this country is set back another 10-15 years – we can see flaws in what is being proposed but so far we aren’t being listened to, yet again we are getting “doctor knows best”.

        • A blog you may find interesting https://jcoynester.wordpress.com/2016/10/10/what-should-be-done-about-the-mega-mecfs-epidemiology-and-genetics-alliance-project-concerns-and-response/

          “At the outset, I should note that Professor George Davey Smith has key responsibility for the genomics section of this complex project. I have the greatest respect for his intellect and intellectual integrity. I have learned immensely from him.

          However, I have serious concerns about other personnel involved in this project in terms of their recent conduct as physicians and scientists. Among other issues, the nature of their role in the project needs to be clarified. Conditions need to be in place that they will not use their role to inflict further abuse and bad science on the patient and scientific communities. Other personnel must step in and demonstrate that patients have an appropriate role in the design, implementation, and interpretation of the data published in peer-reviewed journals in a timely fashion. Patients should be heard, welcomed to high-level participation in research, and not just used.”

          As you can see, there are a few non-patient voices out there, we are just in desperate need of more.

      • “….there is obviously a considerable number of ME/CFS patients who are very well-informed about their condition so has there ever been any attempt to involve them in setting research priorities, developing guidelines etc? I can imagine all sorts of pitfalls but it is remarkable the the researchers feel the need to run a consultation to find out what patients want from research.”

        so has there ever been any attempt to involve them in setting research priorities, developing guidelines etc?

        The answer is YES!!!YES!!!!

        Suffolk and Norfolk folk are leading the way with both issues outlined being addressed through the Suffolk and Norfolk NHS Service Development Working Group – led now by Suffolk Commissioning & the independent charity work of Invest in ME.- We have Healthwatch involved and Local Elected Members -Health Overview and Scrutiny-even tried local MPs one who is on the APPG……
        It is hoped to draw together these two threads into a seamless patient powered initiative to move things in the right direction.

        I hope we will fully answer your question on this next week on the 15th December!

        • Editorial

          Thanks very much for commenting here about this initiative. It certainly seems a step in the right direction but i can hear a cynical voice that wonders if it will be hedged about with so many qualifications that it will end like the latests government initiative to end massive overpayment of CEOs and directors by having workers on the board while at the same time – I think, bit hazy on the details – ensuring there was no chance of unions getting their hands on any levers of power.

          From my experience of the ME/CFS saga I would predict that matters won’t get off the ground if you don’t involve some of those involved in the recent re-analysis of the PACE trial and if you do attempt to involve any of the psychologically orientated researchers who have dominated research to date. It is a tricky area so I wish you luck.

          • The proof of this pudding will be in the eating!It is Christmas after all but I confess there will be few silver sixpences to be found I fear, more of a Scrounge type zervicehe present NHS climate. Never the less, we hope it will be a pointer in the right direction…..

  • I’m a survivor of the original CFS outbreak.
    The entire medical profession, including CFS researchers, have not only lost my trust, they betrayed science.

    Not a single one of them EVER looked into the direct phenomenon that started this syndrome.

    As in “100% EPIC FAIL”

    https://cfsuntied.net/2016/09/13/how-to-make-sure-an-invisible-disease-stays-that-way/

  • Thanks a bunch Jerome for revisiting the ME and CFS saga again It is much appreciated.
    After speaking with you at an Invest in ME conference and alerting you recently via the blog to the PACE tragedy, I am delighted at your response.

    https://www.theguardian.com/society/2002/mar/30/health.lifeandhealth

    http://www.meactionuk.org.uk/Corporate_Collusion_2.htm

    • Editorial

      Thanks for locating that old Guardian piece. You guys have so much stamina! Would be great if the situation did move on. What is it about fatigue that makes the establishment respond in such a punishing way. ME/CSF a subgroup of people with hypothyroid symptoms but blood levels of a thyroid hormone marker within the normal range and people with a serious B12 deficiencies all have a venn diagram like set of overlapping symptoms. In all cases patients report a reluctance to run tests and in the case of B12 and low thyroid sub-group to forbid treatment based on symptoms, so many report gratuitous and damaging under treatment.

      • PS I still have the copy filed!)

        Add to the list above, as well as those with thyroid deficiency or poor conversion, secondary (pituitary driven) secondary adrenal difficulty
        (non Addison) or those with related (Hypothalamus,Pituitary Axis )HPA deficiencies so characteristic and common in ME and CFS.

        Endocrinologists in the NHS are totally constrained in their thinking and practice through fear- and that’s not from fear of patients! Even when the Medicines and Health Authority recognise and license treatment options and medication, consultants are unwilling to respond appropriately.

        Thank goodness for organisations like Thyroid UK (thanks Lyn M!), the qualified “independents”, DR SM, Dr BDP and a few enlightened GPs like our local one, patients are being put at risk-unless they “go it alone” or on line to secure appropriate treatment. The situation is unacceptable.

        • Editorial

          Thanks for those other ones – HPA axis deficiencies is a new one to me – wouldn’t have thought could function at all. But it is still a mystery why endocrinologists have got stuck in this authoritarian treatment denying rut. They behave like the dragon matron in 1950′s medicine – knowing best and expecting patients to follow the rules however damaging and illogical.

          Surely some must have noticed that ignoring the rules can be very beneficial for patients. The GMC got into a dreadful tangle with the sainted Dr Skinner who was allowed to keep treating thyroid patients, contrary to the rules because they so obviously benefited. Remarkably, the people who reported him to the GMC – which happened often – were nearly all other doctors. In at least one case I know of it was a doctor whose patient had been treated by Skinner and benefited hugely. I phoned her to ask why but she didn’t have the time to reply.

          • HPA axis deficiencies, (secondary) adrenal “insufficiency” were even acknowledged by Wessley and co psychiatrists in the 1990′s!
            Published Oxford: Oxford University Press, 1998
            http://capitadiscovery.co.uk/brighton-ac/items/711905

            Viruses, especially glandular fever, are claimed to adversely effect the hypothalamus in the brain.

            “It has now become clear that M.E. is actually a disease process involving many factors, each contributing, but none the main cause. It is now clear that M.E. starts with damage occurring, usually viral, to the hypothalamus. The hypothalamus, deep in the center of the brain, is part gland, and part brain, and controls the whole of the glandular system, through the pituitary gland, just below it. As a result of this damage, the thyroid and adrenal glands, and to a variable extent the ovaries or testes, become deficient. “The loss of proper function of the thyroid and adrenals is responsible for the majority of the symptoms. Much of what follows is based on the work of two celebrated American physicians, who devoted their entire working lives to the unraveling of two inadequately understood and often little recognized illnesses.
            The first was Broda Barnes, who died in 1989, who founded the foundation, which bears his name and carries on his work of the study and treatment of low thyroid function, or hypothyroidism. The other is William Jeffries, who made vast strides in the understanding of adrenal function, especially in deficiency.”
            I have the Jeffries book and am aware of Broda Barnes via Dr. Peatfield.

          • When Dr Rangan Chatterjee performed a near miracle on a badly diabetic patient, by his low-carb approach, nutritionists complained. This was seen in an episode of the ‘Doctor in the House’ series.

            A nutrionist complained about Jennifer Elliot’s successful low-carb approach to diabetics. Elliot was de-registered. After a huge fuss the dietitians organisation said it wasn’t her low-carb advice that was the problem, but a problem with her paperwork!

            Dr Gary Fettke is a Tasmanian surgeon and fierce critic of the low-fat nonsense. He amputates the limbs of diabetic patients and is trying to do something about it. He’s now been barred from speaking on nutrition because of an anonymous complaint. The entire process has been conducted in an appalingly unfair way.

            The Australian Diabetes Association are truly dreadful. They are still promoting the low-fat and high carb approach. Take a look at their spokesman struggle to justify this at minute 34.50.

  • Thank you for your coverage of ME.
    In fact, ‘The Times’ did cover the story. Its science editor, Tom Whipple, has written a couple of articles on PACE.
    One is here (£):
    http://www.thetimes.co.uk/article/exercise-and-therapy-cure-for-me-is-seriously-flawed-cm66p7kc2

    • Editorial

      Thanks for pointing that out. One of the drawbacks of being behind a paywall is that your articles may not form part of a debate that relies on more accessible data.

    • The full article can be accessed on the ME association website.

  • IT must be repeated again the hope of humanity lies in the prevention of degenerative and mental diseases ,not in the care of their symptonms .I did MANAGE to low my cholesterol. Do not dismissed the idea until you try for yourself seek a nutritional expert .There is now too much solid evidence of sustained benefit from therapy to justify this concept.

  • Interesting information on statins and how big pharma are determined to keep us in the dark about the real effects. I took them for almost three years but gave up some weeks ago because of the muscle discomfort. The interesting side effect now is that I feel so much better and seem to have more energy. I have mild Copd and now don’t get so breathless on exertion.
    These improvements are surely not psychological.

    • Julie, I had a somewhat similar experience – getting muscle cramps after three years of use. However, what really upsets me is that while you and I managed to recover fully after abandoning our statins, a fair few people seem to report that they never do recover fully – and some are unable to walk.

      Furthermore, because I had taken statins for 3 years, I had to take the initiative regarding stopping them when I hit problems. There must be numbers of people who never realise that their statins are creating their problems, and just carry on deteriorating.

  • Well done sharing accurate educational information is important My passion is provention i do my best you don’t have to be perfict to provent anything .All you have to do is love yourself enought to do the right thing for you.Everything is proventable it must be repeated again arthritis is purely nutritional state and its treatment is a nutritional one. Unfortunately arthritis research foundations have been issuing statements for many years that nutritional therapy is totally without merit ,thus discouraging most doctors from paying attention to their patients diet Any cure or improvement resulting from nutritional nutritional has therefore dismissed as a spotaneous remission .There is too much evidence of sustained benefit from such therapy to justify this concept .The Arthritis Associatioon has had much success in promoting diet bases on the work of Charles de Coti Marsh ,which is very much with ideas of Dr Hay.We have to change ,Obesity is more serious condition than most people realize,it is closely linked with diabetes ,cholesterol coronary artery disease high blood pressure and stroke. If we have a purpose in our life we don’t become obese you don’t have to be perfect keep trying is good enough .

  • Everything is proventable it must be repeated again arthritis is purely nutritional state and its treatment is a nutritional one. Unfortunately arthritis research foundations have been issuing statements for many years that nutritional therapy is totally without merit ,thus discouraging most doctors from paying attention to their patients diet Any cure or improvement resulting from nutritional nutritional has therefore dismissed as a spotaneous remission .There is too much evidence of sustained benefit from such therapy to justify this concept .The Arthritis Associatioon has had much success in promoting diet bases on the work of Charles de Coti Marsh ,which is very much with ideas of Dr Hay.We have to change ,Obesity is more serious condition than most people realize,it is closely linked with diabetes ,cholesterol coronary artery disease high blood pressure and stroke. If we have a purpose in our life we don’t become obese you don’t have to be perfect keep trying is good enough .

Leave a Reply to Barbara R


WP-Backgrounds by InoPlugs Web Design and Juwelier Schönmann