Who shall guard the guardians?

(Quis custodiet ipsos custodes?)

Mainstream medicine increasingly relies on Guidelines. Well, they are called guidelines, but increasingly they carry the force of law. In many countries if you try to practice outside the wise and infallible guidelines you may lose your license to practice medicine. In the US, you may well be dragged into court, and if you have not been following the guidelines, you will be sued. You can even be gaoled (or jailed, as we say in the UK).

In short, guidelines are very serious and important things indeed, and they now rule medicine with a rod of steel. In the UK up to 50% of general practice time is spend ensuring that all patients are constantly monitored to ensure that various guidelines are rigorously followed. Is the BP low enough, the cholesterol low enough, have you checked blood sugar levels etc.

But where do guidelines come from – exactly? Who gives people the right to sit on guideline committees? What are the entrance requirements? Who shall guard the guideliners?

The answer is, perhaps shockingly, that there are almost no rules to this. If a group, such as the National Institutes for Health in the US, decides to set up a committee to decide on, for example, what is the healthy level for cholesterol lowering, what happens? They ask a number of Key Opinion Leaders to join the committee. In this case the NCEP (National Cholesterol Education Programme – which is a committee, not a programme).

In 2004 this committee decided that cholesterol levels should be lowered far more aggressively than in the past. Based on, as far as I could see, very flimsy evidence.  Could it be that that committee was, in some way, biased in favour of cholesterol lowering companies?  A number of people, including me, demanded to see if any of the eight invited members of this hugely important committee had financial conflicts.

With much reluctance, the conflicts were revealed (I have highlighted, in bold, the companies who marketed cholesterol lowering agents at the time.) See below

ATP III Update 2004:  Financial Disclosure of NCEP members

Dr. Cleeman: (Chairman) has no financial relationships to disclose.

Dr. Grundy: has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.

Dr. Bairey Merz: has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

Dr. Brewer: has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.

Dr. Clark: has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.

Dr. Hunninghake: has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.

Dr. Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.

Dr. Smith: has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.

Dr. Stone: has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.

http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm

Of course, as people have stated to me, the mere fact that there were seventy two financial conflicts of interest does not mean that the guidelines themselves were biased. But you know what, I don’t believe it. Imagine if eight Supreme Court judges, ruling on any issue, had seventy two direct financial conflicts of interest to do with that issue…..Well, the outcry would never end.

Yet doctors, it seems, are beyond any suspicion – of any sort. There is not the slightest possibility that any doctor would ever do anything wrong….We are, after all, superior beings. ‘But, what’s that you say skippy…. hold on.’

‘Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will ever be known…..

The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths

In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.’ http://cardiobrief.org/2013/07/31/european-heart-guidelines-based-on-disgraced-research-may-have-caused-thousands-of-deaths/

Oh well, maybe not.

The fact is that, wherever you look, guidelines are being developed by doctors who have widespread conflicts of interest. And if you go a step further back to review the studies that the guidelines are based on, they are run by, and written up by, doctors who have enormous conflicts of interest. Although sometimes, these conflicts are just…well, forgotten about.

For example, a few opinion leader were ‘named and shamed’ by the Journal of the American Medical Association, when someone pointed out that a number of the authors of the original paper they wrote might just have slipped up in declaring their conflicts:

Unreported Financial Disclosures in: ‘Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis.’

….the following disclosures should have been reported: “Dr Mora reports receipt of travel accommodations/meeting expenses from Pfizer; Dr Durrington reports provision of consulting services to Hoffman-La Roche, delivering lectures or serving on the speakers bureau for Pfizer, and receipt of royalties from Hodder Arnold Health Press; Dr Hitman reports receipt of lecture fees and travel expenses from Pfizer, provision of consulting services on advisory panels to GlaxoSmithKline, Merck Sharp & Dohme, Eli Lilly, and Novo Nordisk, receipt of a grant from Eli Lilly, and delivering lectures or serving on the speakers bureau for GlaxoSmithKline, Takeda, and Merck Sharp & Dohme; Dr Welch reports receipt of a grant, consulting fees, travel support, payment for writing or manuscript review, and provision of writing assistance, medicines, equipment, or administrative support from Pfizer, and provision of consultancy services to Edwards, MAP, and NuPathe; Dr Demicco reports having stock/stock options with Pfizer; Dr Clearfield reports provision of consulting services on advisory committees to Merck Sharp & Dohme and AstraZeneca; Dr Tonkin reports provision of consulting services to Pfizer, delivering lectures or serving on the speakers bureau for Novartis and Roche, and having stock/stock options with CSL and Sonic Health Care; and Dr Ridker reports board membership with Merck Sharp & Dohme and receipt of a grant or pending grant to his institution from Amgen. http://jama.ama-assn.org/content/307/16/1694.3.full?etoc

Not a bad little list. As you can see, Dr Ridker had board membership with Merck Sharp and Dohme…… a company that has made billions from selling statins. Now, here is he is authoring a paper on the benefit of statins (which will be used to develop guidelines on cholesterol lowering), and he simply forgot about this conflict of interest. As for the others, well, they’re also busy people; things must have just slipped their minds, such as thirty three separate financial conflicts.

For this terrible crime against the integrity of medical science, none of them can ever again do medical research, or author a medical paper, or sit on guideline committees. Cue, mad cackling laughter. As you may expect, absolutely nothing happened at all, apart from the publication of that statement you in the Journal in the American Medical Journal (JAMA).

I am sorry, but the system of developing guidelines is, frankly, bust. It has been for many years, but it is a very big and dangerous looking nettle to grasp, and no-one, currently has the will to do it.

Someone, somewhere, needs to ensure that guidelines, and the evidence they are based on, and the interpretation of that evidence, is of the highest quality – and free from potential bias, and financial conflicts of interest. We are about as far from this happy state of affairs as I am from being invited onto any guideline committee, ever, anywhere.

And that, my friend, is a very, very long way away indeed. You would need to Hubble telescope to see across distances as vast as that.

 

22 thoughts on “Who shall guard the guardians?

  1. Sue Richardson

    It’s all very simple really. What is is needed is a Medical Trojan Horse. Doctors and scientists who can pass themselves off as one of ‘them’ and when in influential positions they could suddenly show their true colours and sort them all out! Pigs, of course, might be seen any day flying by our windows with a bottle of statins in their mouths.

    Reply
      1. Sue Richardson

        Well, I didn’t like to say, but Yes. Isuspect be’s doing everything he possibly can already though. Are there any more at home like you Dr K?

  2. celia

    It’s much worse than I thought. What we really need is one of those Parliamentary Inquiries. But who would initiate it?

    Reply
  3. Eddie Mitchell

    Great work Dr. Kendrick

    What with your work, and Dr. Briffa, aka The Shredderator, junk science is getting a very hard time. People are waking up to the fact, so many apparently good guys, are no more than shills for large multi-national food outfits or big pharma. The medical professionals, sticking their heads above the parapet, of out of date and bent science is growing. Please keep shining the spotlight on stupidity, corruption and greed.

    Regards Eddie

    Reply
  4. TC

    Interesting article, as usual. A specific example I have of potential shenanigans is the RCP’s position statement on primary hypothyroidism. See
    http://www.rcplondon.ac.uk/resources/clinical-resources/diagnosis-and-management-primary-hypothyroidism
    While this is not officially a guideline, many GPs seem to regard it as such. The position statement purports to deal with primary hypothyroidism; however it ventures beyond that condition and makes statements that are seriously open to challenge with the result that GPs are misled and end up failing certain patients whose condition is related to the body’s conversion and processing of the thyroid hormones but is not primary hypothyroidism per se. I’ve attempted to find out from the RCP exactly who authored the position statement (and the inaccuracies it contains) but the RCP is adamant that it will not release this information. In other words, the RCP is denying anyone the opportunity to investigate whether the authors in question are conflicted.

    If you, Dr K, or anyone else reading this have any ideas on how the authorship details can be extracted from the RCP, I would very much appreciate hearing from you. I should add that the Freedom of Information Act is of no avail because the RCP is exempt. Interestingly though, the RCP publicly declared back in 2005 that it would do its best to comply with the spirit of the FOIA even though exempt. When I pointed this out to them the RCP reneged on that public declaration and continued to refuse me the information requested. One has to wonder why they are so keen to withhold information that is clearly in the public interest, even to the extent of reneging on a commitment to comply with the FOIA.

    Reply
    1. GG

      These hypothyroidism (non) guidelines are keeping so many patients ill and destroying their health, wellbeing and quality of life. Doctors have to be supported to see beyond the guidelines to see the patient in front of him or her who is suffering more and more. Hypothyroid patients must be about the only group of patients who are offered one form of medication whether it works (or is tolerated by them) or not. This one size fits all attitude (and guidelines) is totally flawed. We need to stop the pharmaceutical companies driving the treatment (and guidelines) and treat patients as human beings.

      Reply
  5. Malcolm Muitt

    Dear Dr Malcolm Kendrick,

    Your muse on the guidelines for cholesterol levels is most interesting. I have recently read an article on the eight doctors you mention, although they didn’t name them and if I recall correctly the full panel was only nine doctors anyway! However this is not just restricted to choloesterol levels and if you have time please read the email I have sent you, it highlights a similar position and possible major flaw in dementia guidelines that has been put to the British government since 2010. It is not just Big Pharma you are now fighting but also Big Business, I can think of one charity with a turnover of £60 million and has its hand in every government committee in its field, and its research is often quotes as fact.
    It really is time that the government took notice of these facts (about cholesterol and dementia) and appointed and supported financially, totally independent and unbiased specialists to oversee the appropriation of all guidelines, it is after all the Government and NHS that is footing the huge bill for medication, and a cure (whether natural or surgical) is far better and cheaper in the long run than a lifetime of pill popping. The Governments continued reliance on advice and guidance from Doctors who have ‘other interests’ is putting patients welfare and quality of life at increased risk of early mortality. The real irony is that these conditions or diseases are indiscriminant and do not just affect the general public, they are just as capable of inflicting a doctor, politician or evcen head of state (think Margaret Thatcher or Ronald Reagan).

    Regards Malcolm M

    Reply
  6. Jean Rochefort

    I am mad as hell of those white coat charlatans. Because of them, whistleblowing the cholesterol scam is considered as a conspiracy theory, on the same footing as the irrational scaremongering by the anti-vaccination movement.
    Anyone with a modicum of honnesty should be sad and scared by such thourough destruction of sound science.

    Reply
    1. Jeff C

      While I agree with the general sentiment, why are the guidelines regarding statins despicable but those regarding vaccination as pure as the driven snow? Both are determined by a small group of appointed individuals rife with financial conflicts to the pharmaceutical industry. In the US, current CDC recommendations are that a child receive 49 vaccine doses before kindergarten, the vast majority before the age of two, including HepB at birth. In 1983, it was 22 doses before kindergarten. In the 1960s, it was around ten doses. So with all these extra vaccines, are kids healthier than a generation ago? Why have infant mortality rates in the US (and other highly vaccinated countries) been stagnant for fifteen years when they continue to fall in other industrialized countries that vaccinate far less (e.g. Japan)?

      Vaccination is an invasive medical procedure that entails risk. As with any such procedure, an individual risk versus benefit evaluation is appropriate. Yet the medical establishment insists that all children must follow the “one size fits all schedule” regardless of health, family history, likelihood of exposure, current antibody titer levels, or past adverse reactions. How is this any different from these ridiculous statin guidelines?

      Those of us that selectively vaccinate our children aren’t “anti-vaccination” but do believe that the bloated and ever expanding vaccine schedule is primarily driven to protect the revenue steams at Merck, Pfizer, Novartis, etc. rather than our children. Note that these companies that have packed the vaccine schedule are identical to those wrapped up in the statin racket, but I’m sure that’s just a coincidence.

      Reply
  7. Dexter

    i recall Dr Mayhill in Wales having her license ripped from her because she was successfully treating patients with a high fat, low carb diet that was lowering blood sugar. This approach was not standard of care. She went to the NIH and appealed and won. She proved no one was harmed by her treatments.

    I wonder if this was the board that caused her so much grief.

    Reply
  8. Sue Richardson

    Did anyone see the article in one of Monday’s papers (Daily Express . Aug 12) saying ‘Millions are at risk because of widespread confusion over the prescribing of powerful heart pills’ (they were talking about statins.) Apparently evidence has been uncovered showing that there is ‘confusion among family doctors about which ‘risk assessment’ they should be using to determine who needs the drug’, which is resulting in some patients are being given statins unnecessarily and as a result ‘sufferirng debilitating side effects’ (unusual to see this being admitted to – are they seeing the light?), and others are not being given them who should be and risking attack and stroke. Apart from the statin question one wonders just how many different sets of ‘guidelines’ the various doctors have been following. They obviously haven’t been following the same ones. If I were taking statins (lol) I would be extremely wary of my doctor after reading this. The doctors deserve some sympathy too I think, because they are being hoodwinked too. What’s to be done?

    Reply
  9. Pingback: To Statinate? Part two – nearing a tipping point? | Dr Greg's Meanderings

  10. FrankG

    Not sure if your original link was slightly off, or if the article was moved for some reason but I had to go find the JAMA’s…

    “Unreported Financial Disclosures in: ‘Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis.’”…

    which is now here… http://jama.jamanetwork.com/article.aspx?articleid=1148176 — one article away from the link you posted above

    I wonder if the board membership with Merck Sharp & Dohme slipped Dr Ridker’s mind due to short-term memory loss and mental confusion..? Is he on a statin perhaps?

    Reply

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