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Evidence-based Medicine - The Paradigm Split

by Dr Samanta-Laughton(more info)

listed in evidence, originally published in issue 131 - January 2007

We have come a long way from the ‘good old days’ of health care. In the past, doctors were able to make decisions about their patients according to their expertise, their knowledge of the patient and even their gut instincts. Whether right or wrong, the days of doctors providing care according to their individual knowledge are gone; we are now in the era of Evidence-Based Medicine.

Evidence-Based Medicine (EBM) is a medical movement which aims to banish the piecemeal approach of the past and replace it with patient care that is based on scientific evidence. Hence, when at the bedside of a patient, a doctor should now make a clinical decision based on knowledge of the latest scientific data.

It sounds like a positive move forward, replacing anachronistic methods which allowed for personal idiosyncrasies. As such, it has been widely embraced by the Medical Profession and has become standard in medical training. It has also been used as a yardstick with which to measure the burgeoning field of Complementary and Alternative Medicine (CAM). Some people claim there is no evidence for such therapies therefore they should not be included in NHS provision.

In this article we shall examine the influence of over ten years of EBM, whether it has been as effective on clinical practice as originally hoped, as well as the implications it has for CAM, before asking deeper questions such as: what is evidence anyway? If EBM is rooted in science, what happens when our scientific model of reality moves onto a new paradigm?

What is EBM?


EBM has been widespread in medical philosophy and practice for over ten years. It is now seen as the gold standard of medical practice; its principles are being applied to many medical disciplines such as physiotherapy.

It is difficult to find a definitive definition of EBM; there are a few versions with common themes.[1] One of the mainstays of EBM is that clinical practice should follow the conclusions obtained from Randomized Controlled Trials (RCTs) and the collation of numerous such studies called a meta-analysis. A properly conducted RCT will pitch an active agent against a placebo or another active agent. The study design involves allocating patients to either the placebo or drug group using recognized randomization techniques. Neither the health personal nor the patients know who is in which group until the end of the trial, hence it is known as ‘double blind’. The collation of such trials into meta-analyses to eliminate the bias of individual studies is an important factor of EBM.

The Verdict


So what is the verdict of over ten years of evidence based practice? The conclusions have rather interesting implications. Firstly, a surprising outcome is that Orthodox Medicine does not work very well. When properly tested in RCTs, it seems that many drugs don’t do all that much.[2] This is demonstrated by the Numbers Needed to Treat (NNT) figures.

The concept of Numbers Needed to Treat (NNT) indicates the number of people that it would take to treat with a particular drug or therapeutic intervention for just one person to benefit. Hence an NNT of 1 would mean that every patient would benefit and an NNT of 5 would mean 5 patients would have to be treated in order to benefit one person. These figures are  based on the scientific evidence from RCTs.

Unfortunately these figures have shown us that Orthodox Medicine is not as effective as originally hoped. The NNTs tend to be quite high, with many in the hundreds. That means hundreds of people have to take a pill to benefit just one person, but it is not possible to know for sure who that person is. So, many people take the medication with no benefit whatsoever.

Furthermore, studies into the actual implementation of evidence-based guidelines in clinical practice have revealed that they are not always followed. At least 30-40% of patients do not receive care according to scientific guidelines.[3] Some studies show that clinicians are more likely to make decisions according to the cultural environment they are in: what their colleagues are doing and saying, etc.[4]

There has also been a backlash against EBM, with people wanting a return to the good old days and away from what is seen as ‘cook book’ medicine. They want to revisit the doctor-led decisions of old, with proper communication with patients leading to informed shared management. In 2004, the British Medical Journal even asked ‘Does evidence based medicine do more good than harm?’[5]

Despite these protests, there is little doubt that EBM is a step forward for healthcare emphasizing the application of science in patient management. It has also been an important issue in the integration of CAM into the NHS. There is a comparative lack of trial data within CAM compared to the expensive industry-funded drug trials of orthodox health care. This lack of evidence is often cited as a major barrier to the inclusion of CAM into the NHS.[6]

However, are these barriers justified? Is there more to the universe than RCTs? Some CAM therapies use concepts such as Energy and Chi that are inexplicable in the medical paradigm. Over the last century, advances in physics have changed how we view the world. We now find ourselves entering a new scientific paradigm – what implications does this have for EBM?

Paradigm Split


We are currently in the midst of a paradigm split in science. The physics of quantum mechanics is transforming the way we see the world. It is forming a new scientific paradigm for humanity: one where the universe is a lot more surprising then we thought.

Trouble is, these ideas have not filtered through to medicine. Yet this new paradigm is at the very cutting edge of human thought. Science as a whole has moved on from the old paradigm view of our universe. If we take these changes into account, it forces us to review the whole philosophy of EBM as it belongs to the old paradigm of science. We shall examine a few of the areas which highlight the differences between the old and new paradigms. 

1.    The World is Solid and Certain


The world of EBM is firmly entrenched in the old paradigm of medicine. This is sometimes called Newtonian science. This is the scientific worldview prevalent before the early 20th century when Einstein’s theory of relativity and quantum physics changed our concepts of the universe.

The Newtonian paradigm says that the universe is made up of solid particles like billiard balls. It was believed that if you split the solid objects around you into small pieces you end up with smaller solid objects called particles. This was the mainstay of science until the early 20th century and this is where the medical paradigm remains to this day.

However, we can no longer ignore the advances of quantum theory: an area of physics that widely regarded as our most successful description of reality. Its resultant technology has given us familiar objects such as compact discs, personal computers and mobile phones. Yet the quantum description of reality, however successful, is also extremely bizarre.

As the physicists of the early 20th century probed deeper into the atom, they expected to find more solid particles. Instead they found a lot of empty space, plus subatomic particles contained within them such as electrons and protons. Again, these were expected to be solid particles, but reality behaves very
differently to expectations.

It was found that a particle is not actually solid at all; it exists as a wave or a particle depending on which way you look at it. If measurements are taken in a certain way, it behaves like a wave of information; if taken as another, it is more like a particle. Furthermore, according to Heisenberg’s Uncertainty Principle, you can never be sure of both its position and momentum at the same time. The more you know about one, the less you know about the other.

This era of uncertainty, wave-particle duality and particles of information has a very different flavour to the old paradigm of a solid measurable universe. This has huge implications for the concept of EBM. If the universe is not solid and is uncertain, how can you measure it with any accuracy? Some argue that this quantum description only applies to very tiny objects and has nothing to do with the real world. However the quantum world is a description of the objects that we see around us. At a microscopic level these objects exist as whiffs of possibilities. Fundamentally, objects are simply information and not really any ‘thing’ at all.
If this is the case, what does that mean for EBM? In a new paradigm world, what exactly is evidence anyway?

2.    The End of Objective Reality


An important aspect of quantum physics is that the actual act of observation has a influence on the subject being observed. It is the act of measuring that collapses the wavefunction into a particle. For the first time in science, it was realized that we, as human observers, have an influence on reality. Until then, we believed that we were passive observers watching a mechanical, soulless universe.

Crucially we believed that we had no effect on reality. Medicine was born out of this paradigm and this is where its philosophy remains. However, in the post-quantum era, we can no longer hold this view of reality as accurate. We now know that we are participators in our universe and that our own observations affect our reality.

This is at odds to the concepts of EBM which relies on an objective reality. Just imagine, if the mind of the experimenter really has an effect on the outcome of a study, how do we view the fact that the pharmaceutical industry sponsors most clinical trials with an eventual profit in mind? It is in their financial interest for the drug to work so the people conducting the trials may possibly influence the outcome of a trial with their intentions. But surely, the influence of the mind of the experimenter is only seen at the tiny quantum level; at the macroscopic level of a clinical trial these effects do not exist.  Not so – the ‘experimenter effect’ as it is known has actually been tested and demonstrated.[7] It is known that even if the experimenter does not directly perform an experiment (and other people do), the outcome varies according to their personal intent.

The end of objective reality, combined with the idea that the universe is not filled with solid dependable objects, rather puts paid to the concept of evidence. In a world of uncertainties, can we really obtain objective evidence? Or, as some people are suggesting, quantum physics has also got it wrong and the universe is absolutely certain. This scenario would also cause trouble for EBM as it has implications for RCTs.

3.    Random Reality


RCTs depend on the concept of randomness. During a clinical trial, it is essential to place patients into different groups on a random basis in order to eliminate bias in the results. There are recognized standards of randomization. However, how do we truly know that something is random? There is no experiment possible that can truly test the random nature of reality.

An article in New Scientist published in 2004 discusses this concept.[8] It even goes as far as to say that randomness is purely human superstition. It argues that our ideas of randomness, even at the quantum level, could simply be a reflection of our ignorance of a deeply ordered reality.  With this sort of scientific
philosophy emerging, how can we be certain of the concept of a randomized controlled trial? If randomness is an unscientific concept, so is an RCT.

Conclusions


As science advances, our concepts of the universe are changing. The physics of the 20th century and onwards show us that our reality is very different from the worldview that was prevalent when medical science was first conceived; there is no solid objective reality. We are even questioning the concept of randomness.

These discoveries have huge implications for the concepts in EBM as they are key to its philosophy. If EBM is scientifically questionable, then how can it be used as a barrier for the integration of CAM into the NHS?

At present, we have a paradigm split with many doctors and health professionals, oblivious to the implications of the new physics on healthcare. However, there is growing public awareness of the concepts of modern physics and its new paradigm. Eventually, these ideas will enter medical science, moving us towards a healing of the paradigm split.

References


1.    Definitions of Evidence Based Practice. University of Sheffield. www.shef.ac.uk/scharr/ir/def.html [cited September 2006].
2.    Hammond P. Evidence-based heroes. PharmaTimes. p32. March 2003.
3.    Grol R and Grimshaw J. From best evidence to best practice: effective implementation of change. Lancet. 362: 1225-1230. 2003.
4.    Gabbay J and Le May A. Evidence based guidelines or collectively constructed “mindlines?” Ethnographic study of knowledge management in primary care. BMJ. 329: 1013-1016. 2004.
5.    Hunink MGM. Does evidence based medicine do more good than harm? BMJ. 329: 1051. 2004.
6.    Baum M, et al.  Doctors’ campaign against alternative therapies. Times Online. 23 May 2006. www.timesonline.co.uk/article/0,,8122-2191985,00.html [cited September 2006].
7.    Rosenthal R and Fode KL. The effect of experimenter bias on the performance of the albino rat. Behavioral Science. 8:183-189. 1963. www.journals.apa.org/prevention/volume5/pre0050038c.html
8.    Stewart I. In the Lap of the Gods. New Scientist. p29- 33. 25 September 2004.

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About Dr Samanta-Laughton

After qualifying as a Medical GP, a Holistic Therapist and working in the Bristol Cancer Help Centre, Dr Samanta-Laughton MBBS Dip Bio-Energy  began a quest to highlight the links between science and spiritual ideas. This has culminated in the publication of Punk Science: Inside the Mind of God by O-books in which she highlights the emergence of a new scientific vision. She is a popular lecturer and has participated in various television documentaries including for the BBC, C4 and Sky and been interviewed by The Guardian, the Sunday Express and others. She lives in Buxton, England and may be contacted via info@punkscience.com; www.punkscience.com

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