A few days ago a friend sent me this headline by e-mail.
‘Guideline Based on Discredited Research May Have Caused 800,000 Deaths In Europe Over The Last 5 Years.’
I would replace the word ‘May’ with these two words ‘almost certainly.’ You would think, would you not, that if any other event in the world, at any time, had killed eight hundred thousand people, this would be front page headlines around the world for weeks, probably months, maybe even years.
Governments would spring into action, those guilty dragged into court. Thousands would protest in the streets, petitions would be signed, laws passed.
The reality is, I am willing to bet, that you have never even heard of this gigantic scandal. It will not have appeared in any national television programme, or newspaper. The blogosphere is also, almost totally silent.
Eight hundred thousand people. Please let that figure sink in for a few moments. If you dropped a major thermonuclear device on Manchester (UK) and killed every single living person, this would be roughly equivalent. If you laid the corpses end to end, the line of dead people would stretch from John O Groats to Land’s End (the entire length of the UK). Walking briskly each day, it would take you two months to pass them.
Think on that.
To an extent the actual guidelines themselves are not the most important thing here. They are now in the process of being changed (although they have not yet been changed). Nobody can be brought back to life, those who could have died – are dead. The issue here is that the processes leading to the creation of guidelines, that have almost certainly killed 800,000 people, are still in place, with no prospect of any change.
Those who have read this blog may be aware of my distaste for medical guidelines, and my concerns about their impact. I wrote an earlier blog called ‘Who shall guard the guardians.’ This outlined some of the problems, but even I was overwhelmed by the sheer scale of deaths involved when guidelines go wrong. I could have worked it out, but never did.
Guidelines are based on evidence, and evidence is based on clinical trials. And major clinical trials are, almost without exception, paid for, run, and controlled by the pharmaceutical industry. The great and good of medicine, the ‘Key Opinion Leaders’ KOLs, who put together the guidelines will almost all have very close connections with the industry. In some cases they will have been paid millions by pharmaceutical companies.
Whether they think so, or not, these opinion leaders are biased. Biased in favour of pharmaceutical products that are promoted through biased research, and launched on an unsuspecting world. And there is no-one out there to check what these KOLs and guideline committees are doing. If, to pluck a name from the air, the European Society of Cardiology (ESC) decides to create a guideline committee, how do they do it?
They choose a chairman, who will be on one of their committees. A well regarded, sound chap, with expertise in the area. He, very rarely she, will then decide on which of his friends and colleagues would be most suitable to be committee members.
They will have a few meetings, gather the evidence together, decide on what best practice should be, and produce their guidelines. No other organisation checks on them, or their decision making, or their conflicts of interest. Or, indeed, the evidence itself.
Yet, when the guidelines come out, many countries will slavishly follow them. They will form the basis for instructions to their medical services. Doctors who fail to follow the guidelines can be censured, or lose their jobs. They virtually carry the force of law.
Something this powerful and important and critical to medical care is dealt with in an almost completely cavalier fashion. Which is, frankly, inexcusable.
I suppose you are wondering what these guidelines were? Well, they were on the use of beta-blockers to protect the heart during surgery. To see more on this story go to the Forbes website
I cannot send you to the article published in the European Heart Journal, because one hour after going up on their website, it was pulled. Here is the comment from the authors of this paper, Graham Cole and Darrel Francis, on the decision of the Editor to disappear the article.
‘Our article is a narrative of events with a timeline figure and a context figure. We had not considered it to contain scientific statements, but we admit that it does multiply together three published numbers.
It is not an analysis of individual trials considering design, molecule, dose and regimen. We published last year the formal meta-analysis under stringent peer review in Heart and addressed the questions, including dosing, in that paper and associated correspondence.
The first of our two EHJ articles merely says that our community, which races to take credit when research-led therapy improves survival, must be equally attentive to the possibility of harm. The leverage of leadership means the magnitude of either may be far from trivial.
Where our article relayed numbers, we made clear that alternative values were possible. The focus for readers was on how serious the consequences can be when clinical research goes wrong.
We thank Prof Lüscher for highlighting the scientifically important point that the pivotal trial, DECREASE I, has not been retracted by NEJM because the investigative committee did not recommend this. Unfortunately the committee could not have done so, because DECREASE I was outside its brief, displayed on the first text page of the first committee report. Can readers suggest why DECREASE I, from the same trial family, was exempted from inquiry?
We admire Prof Lüscher’s diligence in sending for peer review what we thought was merely multiplication. We await the review of the pair of articles. The first narrated one instance of a pervasive problem. The second suggests what each of us can do to reduce recurrences.
We respect the process Prof Lüscher has set in motion. We ask readers to join with us, and the journal, in maximizing the reliability of clinical science for the benefit of patients.’
Well, I am really glad that this article is being sent for peer review, because – as we know – peer review is a jolly good thing. To quote Richard Horton, Editor of the Lancet:
‘The mistake, of course, is to have thought that peer review was any more than a crude means of discovering the acceptability — not the validity — of a new finding. Editors and scientists alike insist on the pivotal importance of peer review. We portray peer review to the public as a quasi-sacred process that helps to make science our most objective truth teller. But we know that the system of peer review is biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong.’
Let me just repeat that last bit. Peer-review is:
….biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong.
Frankly, I wouldn’t hold my breath waiting for peer-review on this matter.
I suppose you may also be wondering how the problem with these guidelines came to light. Well, it turns out that the chairman of the guidelines committee was Prof Don Poldermans. A man who has now been booted out of his job at Erasmus Hospital in the Netherlands for making up his research. The very research that was used to create these guidelines.
Don Polderman’s also had financial conflicts of interest with Merck, Pfizer, Novartis and Medtronic. To name but four. (One conflict of interest statement can been seen here).
Anyway, here is a summary of what has happened:
- Don Poldermans had financial conflicts of interest with several pharmaceutical companies
- Con Poldermans carried out corrupt research, supporting the use of pharmaceutical products
- Don Poldermans was the chairman of an ESC committee that recommended widespread use of drugs to protect the heart during surgery
- Widespread use of drugs to protect the heart during surgery has killed 800,000 people over 5 years in Europe (alone)
- The paper outlining the scale of deaths has been pulled by the ESC
I hope the hell there are no more Don Poldermans out there…..but you would have to be a brave man to think so. Personally, I believe there is an endemic problem with bias and corruption in medical research, and we should be very afraid indeed.
Dr. Malcolm Kendrick 
To press the like button is a real funny way of expressing my appreciation for the post. Just imagine if a Boeing 747 with 440 people on board would come down , killing all people inside.. every day…. for the next 5 years.
This is scary, it’s also Kim’s kind of story!
Rete
Sent from my iPhone
Rita Thompson Personal Trainer 0419 760 176
>
If a 747 jet falls out of the sky the whole worldwide fleet would possibly be grounded. But 800,000 deaths in five years is just covered up.
If you’re on beta blockers be afraid…be very afraid (although that might increase your heart rate….).
Thanks for shedding light on yet another cover up by the pharmaceutical mafia.
This incredible news was on the front page of one of the Dutch daily papers, De Volkskrant, of Jan. 14. Probably because Don Poldermans is Dutch. The article in De Volkskrant talks about ‘thousands’ of victims in Great Britain, and 750 (or 100, that’s not quite clear) a year in The Netherlands.
Dr Kendrick
Only today we read the so called ‘Sugar Tzar’ chairman Professor Ian Macdonald, one of the country’s leading nutritionists, works as a paid advisor for Coca-Cola and Mars. “His research at Nottingham University has now received more than £1million in the past three years from the food industry, including £300,000 from Mars. Funding also comes from Unilever – the world’s largest ice cream manufacturer.” The 800,000 deaths you speak of, is just the tip of the iceberg. All over the world millions of diabetics are suffering and being sent to an early grave because of ‘guidelines’ that have been based on false science, and bribery and corruption, on a monumental scale. Drug companies have been fined $billions, but no one goes to prison, very rarely are people disgraced and fired from their jobs.
Almost every organisation involved in healthcare advice, especially nutrition, has been usurped by big pharma and junk food companies. I believe many organisations are rotten to the core. It is thanks to people like you, we are becoming to know what goes on behind closed doors. I believe people are waking up and listening to those who have knowledge and courage to stand against the tidal wave of lies and greed. I call these organisations, that tell us they have our best interests at heart, Black OP’s outfits, this is the world we live in, and it is getting worse.
Thank you for another great post and helping us see further, but Jeez it can be very depressing at times. All we can do is keep spreading the word, keep hammering away at the mountain, one day it will be reduced to dust. I have to believe that, I don’t want to contemplate the alternative.
Kind regards Eddie Mitchell
Some organisations and the people behind the facade of respectability.
DUK The diabetes charity.
Abbott Bayer Boehringer Ingelheim Bristol Myers Squibb Bupa Bunzl Everyclick First Capital Connect Flora pro.activ Kodak Lilly Lloyds Pharmacy Menarini Merck Serono Morphy Richards Merck Sharp & Dohme Limited Novartis Novo Nordisk Nursing Times PAL Technologies Ltd Pfizer Rowlands Pharmacies Sanofi-aventis Splenda Takeda Tesco Diets
HEART UK -The Nation’s Cholesterol Charity
Abbott Healthcare Alpro UK AstraZeneca BHR Pharma Cambridge Weight Plan Cereal Partners UK (Sh Wheat) Food & Drink Federation Fresenius Medical Care (UK) Limited Genzyme Therapeutics Hovis Kellogg’s (Optivita) Kowa Pharmaceutical Europe Co Limited L.IN.C Medical Systems Limited Merck Sharpe & Dhome PlanMyFood Pfizer Premier Foods Progenika Biopharma s.a. Roche Products Limited Unilever (Flora) Welch’s (Purple Grape Juice)
The British Nutrition Foundation
However, the organisation’s 39 members, which contribute to its funding, include – beside the Government, the EU – Cadbury, Kellogg’s, Northern Foods, McDonald’s, PizzaExpress, the main supermarket chains except Tesco, and producer bodies such as the Potato Council. The chairman of its board of trustees, Paul Hebblethwaite, is also chairman of the Biscuit, Cake, Chocolate and Confectionery Trade Association.
The European Food Information Council
Current EUFIC members are: AB Sugar, Ajinomoto Sweeteners Europe, Bunge, Cargill, Cereal Partners, Coca-Cola, Danone, DSM Nutritional Products Europe Ltd., Ferrero, Kraft Foods, Mars, McDonald’s, Nestlé, PepsiCo, Pfizer Animal Health, Südzucker, and Unilever.
The British Heart Foundation
Unilever Flora margarine.
Stalin allegedly said that a single death is a tragedy, a million deaths are a statistic. I’m not sure where that leaves 800,000. But I do have a suggestion. Let the medical trades adopt a unit, the “Polderman” – plural Poldermen – as 100,000 iatrogenic deaths. Then you could say that Poldermans killed eight Poldermen in Europe alone.
Thanks for reminding me of the word ‘iatrogenic’ ,
Your Polderman unit is a measure of iatrogenicide.
Dearime’s reference to Stalin. My geriatric eyes read it as Statin. Comment still made sense!
Stalin, statin. Easy mistake to make
Great article thank you. I particularly enjoyed your summarising ‘Con’ Polderman’s CV. I take it that was an ‘accidental’ typo!
It was, but I quite like it, and think I shall not change it.
From personal experience only on the use of beta-blockers, post quadruple by-pass operation, I was exceedingly ill for 5 years during which time I thought that each day was about to be my last. Five long years during which time I slept most days and slept at night. I was in a constant slumber and lacked energy. I also had severe neurological problems which the GP denied were post-operative. He was about to send me to see another specialist but after the experience of cardiac surgery I declined. I will not bore anyone with the list of post-operative symptoms that affected me. Initially I was prescribed propanolol but as this gave me migraine-like headaches I refused to take them. I was then prescribed antenolol which I took conscientiously and although they still caused a headache, they were tolerable.
Finding the energy to do anything was difficult. This was 1990 and I still believed in allopathic medicine and the GP was a nice guy and the Internet was not then on the scene. For some reason, which today I cannot recall, I decided to check the medication I was receiving and was astounded by the list of adverse side-effects. This led me to read more on pharmaceuticals which subsequently became a hobby for a number of years. Unlike medics I would purchase drugs (from other countries) and test them so became knowledgeable on many of them. I found a few which were beneficial and had some interesting off-label uses.
I read about the research and benefits of selegiline and obtained some which amazingly controlled my neurological symptoms. Co-Q10 had not been long on the market and the recommended dosage was 5-10 mgs but it had just risen to 30 mgs. I obtained some at 30 mgs and took it without any noticeable effect. Some information was suggesting that 100 mgs was the more appropriate dosage so tentatively I increased the dosage to this level when I experienced a eureka-effect; I was energised and felt normal and immediately abandoned my medication without any adverse effect. Around the same period I was to discover that serrapetase (generic name) taken on an empty stomach cleared arteries of plaque (Dr Hans Nieper).
Regularly, thereafter, I suffered from angina and was prescribed a small white pill (cannot recall its name today) which once more caused a headache. My pharmaceutical interest was expanding into the fields of dietetics and natural medicines when I discovered that taking folic acid at between 2-4mgs (not mcgs as is usually recommended) controlled the angina symptoms and without side effects. Later, around the year 2000, I was to discover serendipitously that polyunsaturated fatty acids and later monounsaturated fatty acids in my diet caused angina. On ramping down on those fats and increasing considerably saturated fats l have since, now age of 83, been in remarkably good health. Fortunately I am one of the survivors of this holocaust.
There is a lot more that I could relate on this subject but that will be for another occasion.
There’s no substitute for good feedback. Thank you Robert. It’s stories like yours that help me to understand just what it is we are dealing with.
Now reading your comment I feel very happy that I did refuse the quadruple by-pass operation offered to me 1999 after my serious heart attack and also turned down all the medicines prescribed after having tried them out for half a year. Instead I changed my eating habits and went for supplements.
Meeting recently with a cardiologist – after 15 years – he told me that he was not interested in what I had been up to during these years. He frankly told me that he considered my behaviour as almost “criminal”.
‘Almost criminal’. Well, I suppose cardiologists must be good judges of criminal behaviour – and ignoring it.
Could you tell me please which supplements you use(d)?
I take Prokardia (see disclaimer)
Dudo van Uden
About supplements.
As trained in natural science I’ll go for the cause and 1999 research led quickly to the main culprit in my case – the transfats which at that time, for all interested, was well known to cause heart problems. No margarine ever since. So no more cookies! And most of the sugar went out as well! In came butter and eggs!
The more I read the more was my distrust in “conventional medicine”. Basically I went for multi-vitamins at large doses as an evidently non-toxic approach contrary to the standard heart medicines. I also added moderate exercise as a “daily supplement” – taking my bike instead of my car to work (12 km).
Currently I now enjoy low carb high fat food (LCHF) and keeping away from vegetable oils (omega-6). LCHF is quite big i Sweden – many reporting strong health benefits – which keeps the medical establishment i constant anger.
And of course a whiskey now and then for my heart.
Thank you so much for your very informative feedback. My faith in the medical profession has been wiped out and although I am doing a lot of research myself I am afraid. Five months ago at age 58 I had an ischemic stroke with multiple lacunar infarcts??? I have made a good recovery thank God, but I am now considered High Risk for another stroke – despite the fact that I didn’t have any ‘triggers’. A month later I attended the Stroke Clinic and it was discovered that I had Paroxysmal Atrial Fibrillation.
I was discharged with numerous medications – and was NOT given any guidance about the side effects!!!! Simvastatin, Bisoprolol and Warfarin. I have taken these drugs as prescribed and have felt quite ill in many ways – but I never associated the statin with the symptoms I was experiencing.
First of all I ached all over and had pains in my joints and muscles. I found it very difficult to stand from a sitting position, to get out of bed and virtually impossible to get in / out of the car – I presumed I had arthritis and it was getting worse! I felt sleepy, listless and depressed – but put that down to the stroke.
I developed pain in the upper side of my right back, found it difficult to bend, felt sick and had difficulty keeping food down.Still I didn’t associate any of this with the statins.
The straw that broke the camel’s back was my increasing memory problems. I was distraught when people referred to situations I had no recollection of – and have since realised that this is some sort of amnesia. I couldn’t remember what I was talking about , what I wanted to say or finish a sentence. In addition to that I could not remember BIG words – like locality/ vicinity etc. I would go out and leave the front door open, leave the freezer open, leave my cash card in the machine, was unable to remember longtime passwords and unable to retain peoples’ names. After being introduced to someone I asked their name 5 times in 10 minutes – and couldn’t retain it, so gave up for fear of looking foolish. I couldn’t make sense of what people were saying / follow instructions and felt utterly confused.
I could go on – I was terrified, and realised that I needed to discuss Care Packages with my children while i was still compus. However, my sister ( whose GP wants to put her on statins – due to the family history of stroke ie ME ) rang and asked me if I was on them because she has done a lot of research on the internet and she WON’T be taking them! I began to put 2 + 2 together, couldn’t get an appt with my GP ( to discuss ) – so took myself off them, preferring the side effects of my condition to those of the statin. That was over a week ago.and although I am not out of the woods yet I feel so much better. In fact other people have commented on the difference they have noticed. I certainly could NOT have composed this feedback whilst on the statins.
.Sorry this is so longwinded but I hope it wil be useful to others. I feel I need to say that I do have another longterm chronic condition ( Epilepsy ) – which has been controlled by drugs for the past 46 years. Taking multiple medications.concerns me,after all –
Who is responsible for monitoring the interaction of the drugs?
Also for those who don’t know, the KETOGENIC DIET ( HIGH FAT ) is recommended as an alternative to drugs for uncontrolled epilepsy – at least in children. I personally have always craved dairy products and have somehow felt that my body was telling me I NEEDED fat ( probably cholesterol )
I am now lost in a sea of confusion! I couldn’t possibly take statins again having had firsthand experience of being poisoned by them.
It is necessary for me to take 15mg of Warfarin DAILY to keep my INR within the therapeutic range.
As for the BISOPROLOL ( 2.5mg daily) can anyone advise on the suitability of this drug for someone with Paroxysmal Atrial Fibrillation?
Many Thanks,
Medicated and Confused
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My mother in law was prescribed a beta blocker, metoprolol, for her high blood pressure when she was 94. It was very high, over 220 systolic, and around 140 diastolic. Her physician also advised her to avoid saturated fats. She was on no other medications, and in fact never went to the doctor as a rule as she said “I don’t trust them, they just give you pills”. But this time for some reason she listened. Within a few days she was listless, her limbs felt heavy, and she was not enjoying her food which usually included eggs, bacon, cheese, french fries bread and butter etc. She did her own cooking. One day a few weeks after the pills and diet change, we noticed that she was back to her old self. She had run out of the pills and decided not to take them any more. We thought that was a good idea, her doctor didn’t, and warned us that she could have a stroke or heart attack at any time. Well, she was 95 after all! And here she is, nearly 102 years old, frail but still gets around, no longer cooks for herself, although we make her whatever she wants for her meals, which is usually high in saturated fats. Her blood pressure these days is around 180/130, but we rarely measure it. Looking back, I now wonder if that high B.P. could have been because of the recent death of her husband, and her having move in with us, she was very sad at having to leave her long-time home.
She must take anti-hypertensives to avoid dying prematurely of cardiovascular disease…..this of course is tricky when you are 94, as you are no longer capable of dying prematurely of anything. The medical profession has gone mad.
I was floored by the 800,000 deaths from one jerks bogus research. I did a Google search of Don Poldermans and found an article that appeared in the prestigious Cleveland Clinic Journal of Medicine from Nov. 2009, titled, The Experts Debate: Perioperative beta-blockade for non cardiac surgery -proven safe or not? It’s Don Poldermans vs P.J. Devereuax. Both are MD PHDs. PJD is from Canada. It’s a long article chockablock with medical jargon but here is PJ’s conclusion.
“It has been 10 years since the recommendation to use perioperative beta-blockers was incorporated into perioperative practice guidelines. Assuming only 10% of physicians acted on this recommendation, 100 million patients have received a perioperative beta-blocker. If POISE results are applicable a full 800,000 of these patients died and another 500,000 suffered perioperative strokes as a result of being given a beta-blocker This issue is not to be taken lightly given the evidence to suggest harm.”
The article appeared in 2009 so why is it breaking news or not such breaking news now? You would think that the Cleveland Clinic would have wanted to look into this matter. Just an aside, but isn’t the Cleveland Clinic the home of your old pal Steven Nissen?
This all makes me quite concerned. My mother has been prescribed two different B/P meds for a number of years. She became quite weak one afternoon while visiting and fainted. We rushed her to hospital. Before I knew it, they recommended a pacemaker. I was told that if she did not get the pacemaker, the next episode would kill her. I am a layperson so I agreed wanting to keep my mother here for as long as possible. Now, I am wondering if she was over medicated with B/P meds. Would doctors actually do that in order to keep patients coming back and to make extra money off these quite costly devices? Recall mother has to have her pacemaker checked quite frequently, which is, again, I imagine another cost associated with the device. Actually one of the leads had dislodged and had remained so for a number of months with no incident save for a bothersome rumbling in her chest. It required her to undergo another surgery to insert the dislodged leed with another. Since scar tissue forms around the leed, it is still there. None of this makes sense to me.
I thought that with regard to peer reviewed studies, those researchers chosen to “review” could not have ANY CONFLICTS OF INTEREST whatsoever. It is my understanding they (at least in the U.S) can only confer with the Editors of these peer reviewed studies, not the authors or pharmaceutical companies themselves and that conflicts of interest had to be checked out thoroughly long before the “review process” is carried out. Aren’t your “peer reviewers” anonymous to the authors or drug companies? It seems clear to me that if the information is correct, Dr. Ponderman should find himself in jail, not enjoying a life only dreamed of in an episode of the Lives of the Rich and Famous. It is, in fact, a criminal act if he “made up” a study which “might have” or probably led to the deaths of nearly 800,000. victims. If found to be true, I have less mercy for Ponderman than I would for the likes of more notable sociopaths such as Hitler and Bernie Madoff. He took an oath to do no harm. More importantly, where is the disconnect here????? Who is “minding the store” as my late father used to say? Where is the oversight or does it exist at all?
This is quite unsettling. I will be watching this one. Am I that naïve? Is the general public that naïve?
Mary, you hoped that someone, somewhere, would make sure that things like this don’t happen….
I think we are naive, and too trusting, and also very lazy in that we don’t want to do research for ourselves, prefering to get our information from the media or the mainstream medical establishment.
My own journey into total skepticism of mainstream medicine started when I was diagnosed with Ideopathic Pulmonary Fibrosis three years ago. I was a critical care RN for many years, I was a total believer in the medical establishment. I was told that this disease carries a 100% mortality within 2 to 3 years of diagnosis, or five years of onset of symptoms. I was told there is no treatment or cure, it just progresses. Coincidentally I also had been experiencing gastric reflux. My Respirologist mentioned it was a common problem with IPF, but didn’t explain why. He offered a prescription for a PPI which I declined. I started reading about reflux, and stopped eating wheat products because they made it worse. The reflux went away and hasn’t returned. I started looking for information which could explain the connection between reflux and IPF, and discovered this:
http://www.canadianpulmonaryfibrosis.ca/research/
It is over two years since I had any symptoms of reflux. The IPF symptoms have not progressed according to CT scan and pulmonary function tests, also by the way I feel, which is pretty good. My theory is that wheat caused Small Bowel Bacterial Overgrowth,which caused reflux, which caused IPF. I had to find out this for myself. Of course I can’t be sure that I have solved the problem, or that it won’t get worse at some point. But I’ve helped myself way more than my doctors did. So, I want to thank, from the bottom of my heart, those doctors and scientists like yourself, Dr. Kendrick, also the Drs. Eades, and Dr. Norm Robillard for your/their generous, unstinting and (I’m sure) exhausting mission to make such important information available to those of us who need and want to know.
New cause of death: D.O.G. Died of Guidelines.
Dr Kendrick,
I wonder if you can give us a little more background on this?
1) What was Con Poldermans (sic) research supposed to be about – was it just a statistical study, or actual research?
2) I thought hospitals kept an eye on death rates for various operations – didn’t the introduction of these beta blockers show up as a downturn in their mortality data? Indeed – if they make a change of this sort, aren’t they looking for some beneficial effect?
There are a number of cases of people faking research in all areas of science. One of the most famous was a solid state physicist, Jan Hendrik Schön. He was caught because he used the same graph – with identical experimental noise – as output from two supposedly distinct experiments!
Something similar has happened in connection with the Western Blot technique – where an image of the electrophoresis gel is typically included in the paper. Again, two identical images were used to represent quite different experiments!
This is scary because any researcher with an ounce of computer programming skill could manufacture unique data (with its own experimental noise) that fitted some sort of template quite easily. In other words, a window may be closing in which such fraud can be easily detected unless the miscreant is REALLY careless.
It seems to me that a fraudulent experiment is exactly that – fraud – i.e. cheating in the work place, and should be a criminal offense, and if lives have been put at risk, the penalty should reflect that also. The problem at the moment is that, like bankers, the system lets even those who are caught get off very lightly.
It was actual controlled research studies. As for hospital mortality data. Lots of noise, lots of variablity, difficult to spot 0.8% signal amongst the maelstrom. Of course you should be worried. Increasingly pharma companies run the studies, input the data, contol everything, and will not release data as it is ‘commerically sensitive.’ The opportunity for research fraud is almost limitless. The only factor contolling it is the morality of those involved.
The think I find scary is the fact that the media is utterly uninsterested. One child is murdered in some horrible fahsion, and we have front page headlines for weeks. 800,000 are killed and there is a collective shrug of disinsterest. How many have to die before most people give any sort of a damn. 8,000,000. 800,000,000. Maybe the figures are just too big, and people avert their gaze.
Dr Kendrick said
“The thing I find scary is the fact that the media is utterly uninterested.”
I believe the media are all part of the giant ponzi scheme. Worldwide the media earns $billions every year in advertising revenue from big pharma and junk food. Think on this, not so long ago James Murdock (he of the News of the World) sat on the GlaxoSmithKline board and was responsible for corporate responsibility. You could not make it up.
Eddie
It really is no surpise that the media is uninterested. Just look at their advertisers….
Most people do not assimilate abstractions very well. A single murder can be reported with all the concrete details, which is what horrify and fascinate people. 800,000 deaths are not susceptible to such reporting. One would have to take out individual cases and go over the concrete details, and then say something like, “now imagine that your entire city is suffering these symptoms–everyone, right now, all at once.” That might register. The hard fact is that the average intelligence is just that–average; and the average imaginative capacity is also just that, average.
This malignant syndrome in society is not exclusive to the cartel of pharmaceutical profiteers. I recall an event in the north of England during the 1960s when a brewery added a substance to its beer to provide it with greater foam so that, at the top of a pint of beer, there was about an inch of foam which appealed to its customers. It was reported at the time that there were almost 200 deaths caused by this additive (presumably a conservative estimate) so it was withdrawn. When one reads today that vegetable oils, which are touted as being nutritious (which they probably are) and are readily available in all grocery stores and used in the manufacture of most foods, but, which are also known, in medical circles, as being ‘potent’ suppressors of the immune system, is there any wonder why the profiteers rub their hands with glee through being economical with the truth?
Some of you who have a little time to spare might find this video by G Edward Griffin interesting: http://www.youtube.com/watch?v=JGsSEqsGLWM
It’s so hard for us as lay people to take the right decisions about our health. There are so many vested interests and conflicting advice. I’ve taken a low dose of Beta Blockers for 3 years to control paroxysmal atrial fibrillation; the palpitations were exhausting and frightening, and I’m very glad to be spared them. Should one take statins or not? The Medical Establishment (and my GP) say yes, but there’s clearly a huge body of evidence challenging that orthodoxy. Then again other studies seem to show that statins can play a useful role: BMJ 2005; 330 doi: http://dx.doi.org/10.1136/bmj.38398.408032.8F (Published 7 April 2005). Trying to sort out the evidence is in itself stressful – and clearly that’s not a good thing!
It’s so hard for us as lay people to take the right decisions about our health. There are so many vested interests and conflicting advice. I’ve taken a low dose of Beta Blockers for 3 years to control paroxysmal atrial fibrillation; the palpitations were exhausting and frightening, and I’m very glad to be spared them. Should one take statins or not? The Medical Establishment (and my GP) say yes, but there’s clearly a huge body of evidence challenging that orthodoxy. Then again other studies seem to show that statins can play a useful role: BMJ 2005; 330 doi: http://dx.doi.org/10.1136/bmj.38398.408032.8F (Published 7 April 2005). Trying to sort out the evidence is in itself stressful – and clearly that’s not a good thing!
Much of the evidence base in medicine is corrupted beyond repair. Especially the evidence base on ‘preventative’ medicine. Too much money, too many vested interests.
An apparently benign invitation just flashed onto my computer screen asking if I was taking statins. This was couched in very safe sounding language, and was seeking volunteers to take part in the Fournier trial, otherwise known as PCSK9 inhibitors. I wonder how many gullible souls they will recruit…
Amen, Dr. K!
Hmmm – not very encouraging! And GPs follow the guidelines because that’s what they’re paid to do, and awkward patients who won’t do as they’re told become a problem…and on the receiving end of doctorly comments like “I have been trained in this you know and there’s only one way to do it…”
I’m horrified by the NHS – the rules, the “guidelines”, the protocols and the complete “jobsworth” mentality. The whole system seems to be based on everyone covering their own backsides, rather than concentrating on “healing the sick” !!!
Apologies to Peter, Paul and Mary- and Bob Dylan
“Blowin’ in the Wind” revisited:
How many people have to take a bad drug
Before so many people must die?
The answer my friend, lies in a vile trend
The answer is quite clear, my dear friend
How many people must lay down their lives
When each one just asks to survive?
Big Pharma has seen, the great golden gleam
Of profits that once were a wild dream
How many men must go to the grave
Before we all see the light?
The answer is clear, it is not even near
That truth and good faith’s lost the fight.
Medical boards, misanthropic Lords
Have taken up a cause that’s unjust
For we mortal men, offer nothing to them
We’re simply a molecular gem
How can it be, that no sense can they see
That each human being’s divine?
They don’t want to know, it’d be a huge blow
To admit that we all are sublime
How many people must die before we can say
Please stop this incredible fraud?
You give us results, based on despicable faults,
And hope that you’ll reap a big reward
Soon you will see, as the public breaks free
Of your virulent hold on the truth
That no more will we, bow down before thee
No longer distant, aloof
Take it from me, you’re no longer free
To rule over humanity
The shackles are snapped, we’re no longer trapped
We’re fixing this disparity.
Very good
Can’t find the study that this headline claim is based on. Do you know where I can find it? My first question when I read a headline like this is – where are the bodies? Are these theoretical extrapolated dead or real cases? Not trying to defend the guidelines – just don’t want to tout some equally lousy counter argument. From what I could find it sounds like there’s much controversy over how to medically manage perioperative patients that already have cardiac issues and the use of beta blockers may do more harm than good and this was confounded by the Decrease trials that are now in question? Is this correct?
Where are the bodies? In the ground. They are extrapolated cases, as they must be. You can’t find the study because it was pulled by the European Heart Journal, one hour after putting it up on line.
I ask because extrapolations require assumptions and I like to examine the assumptions made to see if they are plausible. Since we can’t access the study, I did find this in the comments in one of your reader’s links. From Darrell Francis:
First, the annual number of surgeries in Europe which, according to the same authors [Ref 2] (http://eurheartjsupp.oxfordjournals.org/content/11/suppl_A/A9.full) who are also authors of the current ESC guideline, is 40 million.
Second, from the same expert group of authors [Ref 1] using “stable” data in their own European country, the mortality rate for patients undergoing surgery is 15,200/800,000, which is 1.9%.
Third, if the hazard ratio for initiating a therapy in high risk surgery is 1.27 [Ref 3](http://heart.bmj.com/content/early/2013/07/30/heartjnl-2013-304262.full), the proportion of deaths which would not have occurred if beta blockers had not been given is 0.27/1.27 = 0.21.
The potential number of patients harmed annually is
– the number of annual surgeries,
– multiplied by the mortality rate,
– multiplied by the proportion of deaths that would not have occurred if the treatment had not been given</i?
From a reply in the comments:
Dr. Francis,
If there are 40 million surgeries in Europe annually, 1.9% all-cause mortality, and 21% excess mortality due to beta blockers, that would be 159,600 excess deaths per year or 800,000 excess deaths over 5 years.
However, your simple equations assume that all surgeries performed in Europe have the same risk of adverse cardiac outcome as the surgeries in the beta blocker trials. The trials were conducted in people “at high risk,” “at intermediate risk,” or “having major surgery.” What proportion of those 40 million surgeries are “major” and performed in “high risk” patients? (If, for example, 20% of surgeries are major and 50% of patients are high risk, your number drops 10-fold.)</I
Second, the confidence interval of your meta analysis is barely significant (1.01 to 1.60). So conceivably, the true percentage of excess deaths could as low as 0.9% (or as high as 37%). (If 40 million surgeries are performed annually, the the total sample size of the meta analysis is 5264, or 0.01% of the annual total, is that enough for a valid sample?)
Third, while I respect your meta analysis and understand the need for meta analyses, it’s worth pointing out that of the 9 secure studies you included, 8 had confidence intervals that spanned the 1.0 line.
It seems to me that this figure may be open to some valid scrutiny.
So, if it was 500,000 it would be OK?
If poly (in particular) and mono unsaturated fats suppress the immune system, and sugars have a similar impact, and microwaving food, which apparently alters the structure of protein allowing it to pass from the stomach into the blood stream undigested (causing autoimmune diseases) is there any surprise that our bodies succumb to this unrelenting attack? This is not to mention how today’s food is grown and the poisons to which it is subjected and the additives that are put into public water supplies and the spraying of the skies daily with the chemicals thorium, barium, mercury, aluminium oxide, and strontium, which must, logically, fall to earth affecting the soil and water supply. It truly is amazing that our bodies are able to cope and, yet, this is just to mention a few of the many substances that attack the body. It may be noticed that the honey bee has disappeared but what has caused this to occur and could we humans on the list? Anyone who believes that the breakdown of governments in the middle east, euphemistically termed, The Arab Spring, occurred accidentally or coincidentally, then as Dr Kendrick will be aware, there is also a rusty old iron bridge for sale that crosses the river Forth and it is going cheap to anyone interested.
As users of medicine, we like to think that we are in the hands f exerts who will look after us, but the experts themselves are seemingly being misled. This interview with Peter Gotzsche is one of the most depressing things I’ve read. http://www.anh-europe.org/ANH-Intl+Exclusive+Interview+with+Dr+Peter+Gotzsche+author+of+Deadly+Medicines+and+Organised+Crime
and Cole & Francis’ response to the withdrawal of their article: http://retractionwatch.com/2014/01/20/quickest-withdrawal-ever-journal-yanks-paper-alleging-800k-deaths-from-poldermans-affair/
Here is a light-hearted extract on the same theme as above but from the viewpoint of the recipient at the receiving end of medicine. It is from a Scottish show, spoken in the local vernacular which Dr Kendrick undoubtedly will appreciate but, those like myself will need to hear it more than once to appreciate its subtlety; nonetheless, it is enjoyable and brings a little cheer into life.
Well I had cardiac surgery three weeks ago to replace my aortic valve as I as born with a bicuspid one. I am on a beta blocker, 25mg Atenolol per day. I wish I could read this research. Find out how these people died, why the beta blocker killed them. Very worrying for me to read this as it is impossible for me to judge whether this beta blocker is bad for me or not.
I just read an interesting article in January’s Mayo Clinic Proceedings that evaluated interventional guidelines. The concluded “Most of the interventional guidelines failed to grade the evidence. When present, most guidelines used lower-quality evidence. Furthermore, most guidelines failed to disclose COIs. When commented on, numerous COIs were present. Future guidelines should clearly state the quality of evidence, use a standard grading system, be transparent regarding potential biases, and provide frequent updates.”” Sounds like they’re on the right track, but will it have any real effect?
Dr Kendrick
There is undoubtedly deceit,subterfuge,corruption and laziness in the world of medical research.
I am specialist anaesthetist with a sub speciality interest in vascular anaesthesia at a large tertiary medical centre. I am a clinical anaesthetist with no research activities, not beholden to any pharmaceutical company nor ever in receipt of gifts from such companies.
I am very familiar with all the studies in question
I was appalled,like the majority of practitioners, at the events surrounding Dr Poldermans research and the extent of his deceit and malpractice.
However you “blog” is irresponsible,dangerous and scaremongering. It will cause many who read it unnecessary anxiety and stress.
It is devoid of fact and evidence and will do nothing to further the debate.
There is so much worthy of discussion regarding the whole affair and so many lessons to be learnt. You do not attempt to do that, rather you choose reckless hyperbole and sensationalist superficial headlines.
It is absurd to suggest that you can say with any certainty the potential harm done by his fraudulent research. To casually go on record as saying that you can almost certainly say that 800,000 people have died is ridiculous.
In doing so you confirm your real agenda, which is self promotion and notoriety.
People need doctors and they have a right to expect highly skilled ones. When doctors fail to behave professionally, apologies,debate, education and improvement are what is required.
Polarising debate with nonsense hinders progress and intelligent discussion
The figures of 800,000 were not mine, they were published in the EHJ (on-line) before being pulled. Are you saying that these figures were wrong? These exact same figures were published six years ago. Here I am quoting from the Daily Telegraph in the UK. “Dr PJ Devereaux, a cardiologist and epidemiologist at McMaster University in Hamilton, Canada, who led the research, which was published in the Lancet, said the drugs had cost more lives than they had saved and their use in surgery patients was based on inadequate research. Guidelines established in 1996 by the American College of Cardiology recommend that beta blockers be used in all operations, except those on the heart. The advice was adopted worldwide but Dr Devereaux claimed that the guidelines were based on the findings of two small studies. He said: “On a conservative estimate, if 10 per cent of physicians acted on the guidelines in the last decade, it would suggest that 800,000 people died unnecessarily and half a million had major strokes.” http://www.telegraph.co.uk/news/worldnews/1952818/Betablockers-have-caused-800000-deaths.html
Is Dr P J Devereaux, a cardiologist and epidemiologist – publishing in the Lancet – also guilty of reckless hyperbole, creating sensationalist superficial headlines? Is the lancet a journal of reckless hyperbole and sensationalist, superficial headlines?
As with anyone, I welcome debate, but please do not think that I do not check my facts before writing. By its nature my blog is (from a scientific perspective) superficial. However, the part that I find somewhat annoying is you suggesting that it is I who should apologise (Not Don Poldermans?). Sorry, that seems utterly ridiculous.
I allowed you comment to be published, but in future please avoid personal attacks and insults. You say that my real agenda is self promotion and notoriety. I would say ‘fact, or opinion?’
Have you read Death by Medicine Null, G et al; orthomolecular.org/library/jom/2005/pdf/2005-v20n01-p021.pdf
and the 2012 Annual Report of the American Association of Poison Control Centers “ National Poison Data System (NPDS)” (Clinical Toxicology (2013), 51, 949–1229 -281 pages) outlines the deaths caused by many products in many categories, one of which is pharmaceutical drugs properly prescribed and properly used.
Worth reading. Please note the phrase “properly prescribed and properly used” as applied to the summary of 100,000 deaths. Other reports (JAMA. 2003 Oct 8;290(14):1868-74; West J Med. 2000 Jun 172( 6) 390-3; JAMA. 1998;279: 1200-1205; JAMA. 1998 Apr 15;279(15):1200-5; Journal of Orthomolecular Medicine Vol. 20, No. 1, 2005) re-iterate this failing.
Iatrogenic Deaths Overall
In respect of iatrogenic deaths, in the US, the 2012 Annual Report of the American Association of Poison Control Centers “ National Poison Data System (NPDS)” (Clinical Toxicology (2013), 51, 949–1229 -281 pages) outlines the deaths caused by many products in many categories, one of which is pharmaceutical drugs properly prescribed and properly used.
Incidentally, the 2010 report (and no doubt other years as well) of this organization is essentially similar. In this 2012 report circa 100,000 deaths per annum are found to be due to pharmaceuticals properly prescribed and properly used. Other reports (JAMA. 2003 Oct 8;290(14):1868-74; West J Med. 2000 Jun 172( 6) 390-3; JAMA. 1998;279: 1200-1205; JAMA. 1998 Apr 15;279(15):1200-5; Journal of Orthomolecular Medicine Vol. 20, No. 1, 2005) re-iterate this failing.
This poses the question: Is there anything in the practice of medicine (proper prescription and compliant use) in the UK that precludes the assumption that a similar and proportionate death rates exist here? The present rash of NHS hospitals failings would suggest that they do!
The example examined above are a mere drop in the ocean of those flawed (biased and data selective studies) that abound. BUT NOTHING IS DONE TO RESOLVE THE PROBLEM.
Malcolm, you comment that guidelines are based on evidence, but the question is which evidence? This article of mine discusses the construction of the Australian Immunisation Handbook (and also touches on the case of Dr Gaary Fettke, an orthopedic surgeon in Australia who has had trouble for giving dietary information (LCHF).
Now there are deveral problems with evidence selection- firstly the process of selection and exclusion of evidence is opaque– we are told what the process is, but I think it would be a very tough job to get hold of the actual papers that were reviewed, or how much time was spent reviewing them.
Secondly the papers were naturally 2 years out of date by the time the handbook is published.
Thirdly the following exclusions apply:
• Language – searches were limited to items in English.
• Human – items discussing only animals were removed.
• In vitro – items discussing only in vitro studies were removed
• Abstracts – search results restricted to items containing abstracts.
So, by the time of publication, the research base was already 2 years out of date. In some areas it may be much more. For instance the Cochrane Collaboration was mentioned. The most recent Cochrane review of aluminium adjuvants appears to be 2004, based on 21 papers, all published between 1968 and 2003. By way of comparison a quick check on Pubmed using the terms “aluminium” and “neurotoxicity” revealed 417 papers, and many of them were recent.
Now the problem is that there is no doubt that aluminium is neurotoxic (the only doubt is “at what dose”?- and that is an open issue due to the never ending additions to the vaccine schedule, and the never ending lifetime dose of injected aluminium) so it is probably impossible to do human studies on aluminium without breaching ethics committee guidelines.
So the exclusion on in vitro and animal studies is preventing important information from coming to light.
No doubt similar issues will be found with other sets of guidelines.
Statins made me very ill. Off them now. Been put on Resolor but after 2 weeks terrible pain. Dr taking me off.