Positive Health Online

I stand at the quayside looking upwards at the huge ship. I can’t remember her ever not being there; and people tell me that she has been part of the harbour skyline since the beginning of Man’s time on earth. She has sat silent, safe and lawful over millennia, but some years ago, work started on her in preparation for possible departure. No one really believed it would come to this but over recent years the pace of the work has increased, until now She is the centre of feverish activity.

The crew is almost all on board, volunteers to a man (and woman) they have elected to take her to sea rather than have her scuttled where she lies. I, with a few of my peers, have come early to witness the preparations. Although the passenger list has not yet been announced, we know that our names will appear on it. Not a pleasure-trip, this but an opportunity for survival, the only one, leaving behind those souls who will not appreciate our loss until we are out of sight.

Behind me I hear the murmuring voices of the Academics and Politicians who are already putting the finishing touches to the expulsion order, “For its inability to meet the criteria set by Evidence Based Medicine, The SS Holistic Medicine is hereby banished from these shores,” it says.

Please forgive the poetic licence, but the increasing dependence on the scientific proof of efficacy, once limited to Conventional/Orthodox Medical practice is now descending upon Complementary and Alternative medicine, including those practices that are rooted deep in history and dependent upon anecdotal evidence and subjective evaluation. If the trend continues, and we are required to submit to validation solely by scientific means before being permitted to practice, the whole future of holistic medicine will be in doubt.

What is EBM (Evidence Based Medicine)?

“Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patient’s predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens.”…” Evidence based medicine is not restricted to randomized trials and meta-analysis.” So wrote Professor David Sackett et al in his definitive article in 1996.[1] It continued:

“Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient.” This is a well-balanced and considered view, and one that Complementary and Alternative Medicine (CAM) would share. It was then followed by the observation

“Some fear that evidence based medicine will be hijacked by purchasers and managers to cut the costs of healthcare. This would not only be a misuse of evidence based medicine but suggests a fundamental misunderstanding of its financial consequences.” And a well-founded fear because now, ten years after publication, this is exactly what is happening.

John Garrow, chairman of HealthWatch asked, “Who really provides the evidence; Very Senior Clinicians or Omniscient Meta-analysts?”[2]

The answer today is, the ‘Omniscient Meta-analysts’ who are locked into systematic reviews of numerous and diverse random controlled trials, the results of which are held and published by specialist libraries. This Cochrane technique employs people who are experts at extrapolating from data and presenting conclusions. They are not clinicians and may have little or no experience of treating conditions. Neither are they scientists, in that they can be expected to differentiate between a well-managed and meaningful trial and one that is flawed. By failing to acknowledge experience and anecdotal evidence in their conclusions, the ‘science’ is reduced to no more than simple statistics.

Mr Garrow goes on to say, “Evidence based medicine that is based on bad evidence is bad medicine”.

Are We Bovvered?

Well, we should be, because what is now the clarion call for orthodox healthcare could soon to be unleashed on CAM.

“As complementary therapy becomes an accepted and integrated part of healthcare, the need for effective regulation becomes paramount.”[3] This part of Professor Stone’s conclusion in her report for the Foundation for Integrated Health summarizes the future of CAM as seen by government.

Her statement makes two assumptions, one, that CAM is to become accepted and integrated into our national healthcare portfolio, and two, that it can and will be effectively regulated.[4] Both well-founded.

The Government has made it quite clear that they wish to see the whole of healthcare regulated in the UK, and that regulation of health professions should be coordinated with existing health service provisions using the NHS model as a basic framework within which to build an integrated structure that can be objectively applied across all professions.[5]

The Princes Foundation for Integrated Health was, at the time of preparing this article, considering the results from its consultation document into the formation of a Federal Council for the Voluntary Regulation of Complementary Medicine which, if accepted as a proposal, is another step towards the government’s eventual goal of defining operational standards against which to regulate with appropriate standards of proof.[6]

What standards is the government likely to adopt? We should be bovverred.

Hijacked

Those who promote EBM as the only safe method of evaluating efficacy of a treatment have determined that only scientific sources of evidence should be considered. The weight of evidence is supplied, not through rigorous experimentation, but from randomized clinical trials and Cochrane library material. The problem is not just that these sources may not be scientific, but that their conclusions are often accepted without reference to the quality of the trials they report, which in many cases are badly flawed. This is a risk to best patient care when applied to conventional/orthodox medicine. However, these trials are, in the main, based on allopathic principals of cause and effect, specific disease resolution / prevention or chemical change, most of which are largely irrelevant to the evaluation of much CAM practice, so not only is the protocol risky but as far as we are concerned, it is also inappropriate.

A Couple of Examples

In the BBC2 Open University series Alternative Medicine (earlier this year), Kathy Sykes reported on herbs as containing much more than a single – or even two or three – active ingredients. They are enormously complex chemical cocktails that have medicinal properties modern pharmaceuticals simply can’t reproduce. Speaking of one particular plant, Echinacea, she commented that there is no science in existence that can come close to evaluating the multiplicity of complicated synergistic effects, and therefore, is not in a position to examine claims that it enhances the immune system. So there is no scientific biochemical test available for Echinacea.

So EBM has to rely solely on random controlled trials.

The herb Echinacea was trialed seven times between 1999 and 2004 for its ability to prevent or cure colds. A Cochrane search in 2006 relied upon these trials to conclude that there was no evidence to support the efficacy of treatment with Echinacea on upper respiratory disease in children.[7]

The trials themselves were variously criticized as “Effects on duration of cold not examined”, “Small sample size”, “Authors’ interpretation of the results controversial”, “Drug Company sponsored”, “Only relief/decrease of symptoms examined”.

The actual conclusion may or may not be a true representation of the effects of Echinacea on juvenile rhinovirus infection… but although worded correctly, by the time the message is broadcast, Chinese whisper syndrome takes effect and it becomes “There is no evidence to support the therapeutic value of Echinacea”, and therefore, by default, public and medical opinion becomes “Echinacea doesn’t have any therapeutic value”. The end result is that it becomes unavailable for medical prescription, the public stop self prescribing it and Nutritional Therapists and Herbalists are labelled quacks.

When looking at these trials the first thing that I see is that a treatment is being tested for its ability to cure or prevent a specific, differentially diagnosed disease. CAM Practitioners don’t, in the main, treat for the purpose of curing disease. We are in the business of promoting health, so the whole basis for these trials was, in CAM terms, fundamentally flawed at the outset.

Double Whammy I

The conclusion on the value of Echinacea was reached on how it affected one specific disease on the result of the systematic review of seven trials, five of which were acknowledged as flawed and only one included the specified group.

a) The trials were flawed; and b) only one medical condition was tested.

And

A recent determination by Professor Edzard Ernst’s department at the Peninsular Medical School at Exeter University concluded that there was no evidence to support Homeopathy as an effective treatment.[8]

This is the same man who had his first post in a Homeopathic hospital in Munich, where he was greatly impressed, and said in an interview: “If you study Medicine and Pharmacology, you know [Homeopathy] can’t work. The active substances in homeopathic medicines are so diluted that Pharmacology says they cannot have an effect. Then you start working in a Homeopathic Hospital and people get better. Is that a miracle? It certainly is very impressive for a young doctor.”[9]

A scientist will tell you that there is no such thing as negative evidence. You can’t prove that something doesn’t work. All you can say is that science has been unable to prove that it does work. The conclusion that found popularity in the press and media that Professor Ernst had proved that Homeopathy did not work was, therefore, scientifically terminally flawed. However, they don’t call it ‘the popular press’ for nothing, and no matter how flawed the conclusion, people believe it, and those with self interests to promote can capitalize on that belief.

That this particular piece of ‘research’, which relied heavily upon Cochrane library material and small trials, is accepted as Evidence Based Medicine is a form of expediency that brings science into disrepute. The truth of the matter is that at this time science has no objective means of definitively testing the effects of Homeopathy, and is willing to let the Cochrane technique stand alone as arbiter and ignore clinical experience and anecdotal evidence.

If the same test of validation were applied to parachutes or life preservers they would be taken out of service, because no randomized double blind placebo controlled trials have been performed on them, and therefore, no systematic review possible. Thank goodness for old fashioned scientific experimentation.
As with many other forms of CAM, the benefits of Homeopathy are perceived subjectively, and therefore, objective scientific testing of benefit is doomed to failure. You just cannot measure temperature with ruler no matter how well-intentioned.

Double Whammy II

How can we accept the bastardized version of EBM as being science-based. Bio-chemists and Bio-physicists have not yet developed a scientific basis for testing effects of holistically applied treatments, so it isn’t possible to subject many of our treatments to true scientific scrutiny.

Systematic review is little more than a statistical analysis of allopathically-based clinical trials. Mark Twain is accredited with saying “there are lies, damned lies and statistics”. Statistics are not generally well understood, and they are easily used to mislead the public and professionals alike. It is very easy. A statement like “the chances of two people having the same fingerprint are billions to one”, is pretty robust until it is put into the context of a second statistic that the rate of error in fingerprint identification is a hundred to one.[10]

EBM Removes Choice

I recently attended my GP for a medical examination (MI) to get a PCV (Passenger Carrying Vehicle) driving licence. He assured me that they only wanted to know that I wasn’t likely to drop dead at the wheel… something that I would also quite like to be assured of myself. I had an MI about 20 years ago, and once my life had been saved by scientific-based conventional medicine I didn’t go back to have it jeopardized by long-term evidence based medication. My GP advised me that he could not endorse my continuing to take a magnesium supplement, but that he had to recommend that, take Aspirin and Statins because these were the industry prescription guidelines.

Our own Prime Minister stated, “…we had started patient choice”, and that this was “being exercised by hundreds of thousands of patients every year”.

As if answering my question “What Choice”, he concluded by saying “patients are being given a choice of NHS provider” and that “this choice is already available in the private sector”, which, taken in context means that he sees a system where patients can choose where and when to be treated, but not how and with what.[10]
 
Echoes of Henry Ford’s famous saying of his Model T ring out: “You can buy it in any colour you like as long as it’s black”. He may have gone on to say “but you do have a choice…you can by it from any dealer you like”.[11]

Science or Expediency?

EBM is definable, repeatable, controllable and cost-effective. It is, therefore, suited to institutionalized objective medicine and bureaucratic regulation.

EBM is not subjective, adaptable, intuitive and holistic, and is, therefore, not suited to CAM practice or clinical regulation.

Our inexorable journey into Voluntary Self Regulation (VSR) will inevitably lead to more regulation. Although regulation and subjective treatment are mutually exclusive terms, much effort is being put into the protection of holistic practice by a multiplicity of organizations including my own, the Fellowship of Holistic Integrated Therapists (FHIT) and the over-arching authorities like the British Complementary Medicine Association (BCMA) in their representations to the Prince’s Foundation for Integrated Health (FIH) and Government.

However, the Government already has a mandate under the Health Professions Order of 2001 to compulsory and statutorily regulate health professions, and it is the Author’s opinion that once VSR has been achieved, those who wish to replace clinical regulation with bureaucratic regulation will redouble their efforts to convert VSR to statutory regulation, under a group regulatory scheme similar to that currently being operated by the Health Professions Council (HPC), or the one described as a ‘Federal Council’ and proposed by the FIH.

This would, if the present trend continues, lead to validation of treatments by EBM only and split CAM into two; those who will abandon holistic practice and stay and work under the system, and those who will join me on board the SS Holistic Medicine which would, by this point, be ready to set sail.

If I wait by the quayside how many of you will join me for embarkation and how long will you wait?

References

1.    Sackett DL, Rosenberg WMC, Muir G JA, Haynes RB and Richardson WS. Evidence Based Medicine: what it is and what it isn’t. BMJ. 312:71-72. January 13 1996.
2.    Garrow J. Who Examines Evidence? Student BMJ. 11: 1-42. ISSN 0966-6494. February 2003.
3.    Stone J Prof. Development of Proposals for a Future Voluntary Regulatory Structure for Complementary Health Care Professions. The Prince of Wales Foundation for Integrated Health. September 2005.
4.    Faculty of Public Health. The Royal College of Physicians of the United Kingdom. Policy and communications. 2006.
5.    Review by the Department of Health. The regulation of the non-medical healthcare professions. July 14 2006.
6.    Regulation update. FIH. August 2006.
7.    Koenig K and Roehr CC-tbc. Does treatment with Echinacea purpurea effectively shorten the course of upper respiratory tract infections in children? Children’s Hospital. Charite Universitatsmedizin Berlin. Germany. May 26 2006.
8.    FACT. Volume 11. Issue 1. March 2006.
9.    Boseley S. Interview. The Alternative Professor. The Guardian. September 25 2003.
10.    Rt Hon Tony Blair MP PM. Speech. To a meeting of The New Health Network Clinician Forum. April 18 2006.
11.    Atlantic_Cable. The Guide to Life, the Universe and Everything. How to Understand Statistics. BBC2 h2g2. July 28 2003

Further Information

For more on Brian and his work visit www.medicsense.uk.com and/or www.thehealthteam.uk.com.