Tag Archives: EBM

Is medical research now beyond redemption?

55 Replies

Below, I have copied an entire article from the BMJ, written by Dr Des Spence, who is a fellow Scottish GP. We communicate from time to time, and share a general view that medicine is heading in a very unfortunate direction with overdiagnosis and over-treatment/polypharmacy becoming a massive problem.

This is driven, in the main part, by the pharmaceutical industry. An industry that would like to see the entire population of the world taking medication every day….. forever. To achieve this they have, effectively, grabbed hold of medical research and twisted it to their own ends.

Anyway, please read this article. It encapsulates much of what I feel, and I believe it needs a wider audience [I have added a few comments into the text to ensure that I am not breaching copyright]

Evidence based medicine (EBM) wrong footed the drug industry for a while in the 1990s. We could fend off the army of pharmaceutical representatives because often their promotional material was devoid of evidence. But the drug industry came to realise that EBM was an opportunity rather than a threat. Research, especially when published in a prestigious journal, was worth more than thousands of sales representatives. Today EBM is a loaded gun at clinicians’ heads. “You better do as the evidence says,” it hisses, leaving no room for discretion or judgment. EBM is now the problem, fuelling overdiagnosis and overtreatment.

[This is now a major problem for GPs who are increasingly measured and monitored, and funded, according to how accurately we follow guidelines mk comment]

You see, without so called “evidence” there is no seat at the guideline table. This is the fundamental “commissioning bias,” the elephant in the room, because the drug industry controls and funds most research. So the drug industry and EBM have set about legitimising illegitimate diagnoses and then widening drug indications, and now doctors can prescribe a pill for every ill.

[As you can imagine, this makes it difficult not to prescribe statins mk comment]

The billion prescriptions a year in England in 2012, up 66% in one decade, do not reflect a true increased burden of illness nor an ageing population, just polypharmacy supposedly based on evidence. The drug industry’s corporate mission is to make us all sick however well we feel. [Absolutely true mk comment] As for EBM screening programmes, these are the combine harvester of wellbeing, producing bails of overdiagnosis and misery.

Corruption in clinical research is sponsored by billion dollar marketing razzmatazz and promotion passed off as postgraduate education. By contrast, the disorganised protesters have but placards and a couple of felt tip pens to promote their message, and no one wants to listen to tiresome naysayers anyway.

[Speaking as a tiresome naysayer I could not agree more mk comment]

How many people care that the research pond is polluted, with fraud, sham diagnosis, short term data, poor regulation, surrogate ends, questionnaires that can’t be validated, and statistically significant but clinically irrelevant outcomes? Medical experts who should be providing oversight are on the take. Even the National Institute for Health and Care Excellence and the Cochrane Collaboration do not exclude authors with conflicts of interest, who therefore have predetermined agendas. The current incarnation of EBM is corrupted, let down by academics and regulators alike. [If anyone has any suggestion how to improve regulation, please let me know mk comment]

What do we do? We must first recognise that we have a problem. Research should focus on what we don’t know. We should study the natural history of disease, research non-drug based interventions, question diagnostic criteria, tighten the definition of competing interests, and research the actual long term benefits of drugs while promoting intellectual scepticism. If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen.

[There have already been many disasters, but nobody has yet listened mk comment]

Original article can be found here

Sorry about the intrusive comments, but I don’t want the BMJ jumping up and down on me – especially as they are the only major journal that seems keen to criticize the industry.

What Des Spence is saying, is what I have been saying for some time now. Evidence Based Medicine (EBM) could have been a great thing – so long as it was not enforced too rigidly. But the evidence has been manipulated and corrupted all the way along the line. EBM is now almost completely broken as a tool to help treat patients.

Some years ago I stated that I no longer believe in many research papers that I read. All I tend to do is look at the authors, look at the conflicts of interest, look at the companies who sponsored the study, and I know exactly what the research is going to say – before I have even read the paper.

I have also virtually given up on references. What is the point, when you can find a reference to support any point of view that you want to promote? Frankly, I do not know where the truth resides any more. I wish to use evidence, and the results of clinical studies, but I always fear that I am standing on quicksand when I do so.

We are at a crisis point. Medical research today (in areas where there is money to be made) is almost beyond redemption. If I had my way I would close down pubmed, burn all the journals, and start again, building up a solid database of facts that we can actually rely on – free from commercial bias. But this is never, ever, going to happen.

Happy New Year.

 

Bias, bias everywhere

23 Replies

For hundreds of years, medicine was driven by anecdote and personal beliefs, without the slightest supportive evidence. In the nineteen twenties the most common operation done was ‘removal of toxic colon.’ Toxic colons were believed to be responsible for almost any symptom you could think of.

  • Headache…..toxic colon
  • Anxiety…toxic colon
  • Stomach pain…toxic colon… obviously
  • Cramps…toxic colon, etc. etc.

Surgeons became blindingly wealthy cutting out significant lengths of the large bowel in those who could afford it. This operation, and the greed and stupidity that drove it, is outlined in the book ‘Doctors Dilemmas’, by George Bernard Shaw.  He went on to say that: ‘If you pay people to cut things out of you, then that it exactly what they are going to do.’

Not many people have their toxic colons removed nowadays, in fact no-one does, as the condition no longer even exists. But many people still have coronary artery bypass grafts done. Although there is not the slightest evidence that this does any good either. For more on this read Bernard Lown’s essay

Anyway, over time doctors began to recognise that if you were going to cut things out of people, or prescribe drugs, it would be nice to know if any of this activity actually did any good. And so began the dawning of the age of evidence based medicine (EBM). (Evidence based medicine is a far more recent movement than you might think, not really getting under way until the 1980s).

The individuals who really drove this forward e.g. Sackett, Cochrane, Muir-Gray were extremely hard working idealists. They were highly ethical and had the patient’s interest at heart. They taught EBM on wards with students, and looked for evidence wherever they could find it.

This was a much more difficult thing to do before the advent of the world wide web. I remember searching around for papers in medical libraries, taking literally hours to find the papers I was looking for. Something I can now do in seconds on the Internet.

In theory, of course, EBM should be a very good thing, and in some ways it has been. However, EBM relies entirely on the belief that the evidence you are using is accurate, or true, or believable, or unbiased, or whatever form of words you are most comfortable with. This may have been true once upon a time, but things have most certainly changed.

In the early days a great deal of research was carried out in major teaching Universities. Doctors and researchers would set up the trials, run them, and analyse the results. However, the turn of the millennium less than a third of drug related studies were being done in academic units.

To quote from the New York Times:

‘The removal of research from academic centres also gives pharmaceutical companies greater control over the design of studies, analysis of data, and publication of results.

The end result: among even the highest quality clinical research the odds are 5.3 times greater that commercially funded studies will support their sponsor’s products than non-commercially funded studies. The authors conclude, “Readers should carefully evaluate whether conclusions in randomized trials are supported by data.” Careful readers with enough time can sometimes spot discrepancies between data and conclusions in published studies. However, the drug companies typically retain control over the data from their sponsored trials so the majority of the researchers don’t have open access to the results from their own studies.’ Petersen M. ‘Madison Ave. has growing role in the business of drug research.’ New York Times, November, 2002.

In a similar, if less emotive vein, the most downloaded paper within recent medical scientific literature was written by John Lonnadis. It was entitled ‘Why most published research findings are false.’

The vast majority of people have never heard of this paper. The vast majority of those who have heard of it have never read it, and the vast majority of those who have read it, have clearly not understood the implications of what they have just read. Or, if they have…they are too frightened to do anything about it.

The shortest summary of his research is, as follows:

‘Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.’ J Lonnadis.

These words sound relatively mild, but the implications are explosive. Basically, many researchers are claiming that they have proved something to be true, but all they have actually done is to manipulate their research in order to confirm what they already ‘knew’ to be true.

In essence, medical research has become horribly biased, to the point where David Sackett (a hero of mine) has virtually withdrawn from the arena

‘According to the founder of Evidence Based Medicine experts are hindering the healthy advancement of science.

Writing in this week’s British Medical Journal (BMJ), Canadian-based researcher, David Sackett, said that he would “never again lecture, write, or referee anything to do with evidence based clinical practice”. Sackett is not doing this because he has ceased to believe in evidence based clinical practice but, as the BMJ comments, because he is worried about the power of experts in stifling new ideas and wants the retirement of experts to be made compulsory.

Sackett claims that the prestige of experts (including himself) gives their opinions far greater persuasive power than they deserve on scientific grounds alone.”Whether through deference, fear, or respect, others tend not to challenge them, and progress towards the truth is impaired in the presence of an expert,” he writes.

He also argues that expert bias against new ideas operates during the review of grant applications and manuscripts. “Reviewers face the unavoidable temptation to accept or reject new evidence and ideas, not on the basis of scientific merit, but on the extent to which they agree or disagree with the public positions taken by experts on these matters.” http://www.abc.net.au/science/news/health/HealthRepublish_124166.htm

When the man who virtually invented evidence based medicine states that research has become institutionally biased, where can we look? I am not sure. I will leave you with a thought from Professor Bruce Charlton

The decline of honesty in science

Anyone who has been a scientist for more than 20 years will realize that there has been a progressive decline in the honesty of communications between scientists, between scientists and their institutions, and between scientists and their institutions and the outside world.

Yet real science must be an arena where truth is the rule; or else the activity simply stops being science and becomes something else: Zombie science. Zombie science is a science that is dead, but is artificially kept moving by a continual infusion of funding. From a distance Zombie science look like the real thing, the surface features of a science are in place – white coats, laboratories, computer programming, PhDs, papers, conference, prizes, etc. But the Zombie is not interested in the pursuit of truth – its citations are externally-controlled and directed at non-scientific goals, and inside the Zombie everything is rotten…..

Scientists are usually too careful and clever to risk telling outright lies, but instead they push the envelope of exaggeration, selectivity and distortion as far as possible. And tolerance for this kind of untruthfulness has greatly increased over recent years. So it is now routine for scientists deliberately to ‘hype’ the significance of their status and performance and ‘spin’ the importance of their research.

Bruce Charlton: Professor of Theoretical Medicine

So, what can be done?