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Comment on an open letter to Professor Edzard Ernst from Dr Lionel Milgrom
- Leslie Rose (6 March 2007)
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Reply to Lettery by LR Milgrom
- Edzard Ernst, Les Rose (5 March 2007)
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Homeopathy and Randomised Eminent Professors (Emeritus or Otherwise)
- Lionel Milgrom (14 July 2006)
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Homeopathy and the Lancet... and worse
- Paul Lepine (22 February 2006)
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Leslie Rose, Clinical Science Consultant United Kingdom
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As a co-signatory to the letter to which Dr Lionel Milgrom refers, I have been shown his open letter to Professor Edzard Ernst. Despite its length, Milgrom's letter says nothing new about homeopathy. Rather than reply to a similar extent, I will confine these comments to the grosser misconceptions. It is no surprise that the debate centres on what constitutes evidence. Milgrom perpetuates the notion that there is more to the human body than 'intelligent bags of chemicals'. This of course harks back to the ancient concept of vitalism, but despite the labours of centuries there is still no objective evidence for it. The harder we look, the more we are reassured that biochemical and biophysical processes explain what goes on in the cell, comprising recognised phenomena that fall within the scope of what we know about science. There remains no evidence whatsoever for any kind of 'life force', however it is named. How curious that Milgrom still clings to the discredited work of Benveniste. By stating that homeopathy’s claimed effects "could well be (my italics) due to some kind of epitaxial 'formatting' of water's dynamic long-range molecular structure", Milgrom is admitting that he really does not know, and is speculating. Speculation in science is fine, but it has to be tested – and tests have been done and have failed. One has to ask what happens to this 'formatting' when the water evaporates from a dry tablet. By insisting on merging specific and contextual effects, Milgrom is tacitly agreeing that homeopathy has no effects of its own. Surely what we need to know is whether substances 'diluted out of existence' (his own words) have any intrinsic activity? Contextual effects are simply being used as a smokescreen for homeopathy's lack of efficacy per se. Milgrom completely misunderstands (or chooses to) that the RCT is just a specialised form of the controlled experiment, on which all that we know about the universe is built. He rejects it because of its ability to separate truth from fiction, yet at the same time relies on it for the few studies which apparently do support homeopathy. He fails to recognise the inverse relationship, reported in the peer-reviewed literature, between study quality and the strength of outcome in favour of homeopathy. He ignores the topmost level in the hierarchy of evidence, the meta-analysis, which confirms this. Overall, Milgrom denies the scientific method itself. How does he, with a clear conscience, maintain credentials based on real science? The remainder of his ad hominem attack hardly warrants close examination. It is a measure of his attention to detail to note that our letter was not addressed to The Times, but to chief executives of NHS trusts. We have only received supportive responses so far. Finally, I believe that the remit of the Chair in Complementary Medicine at the Peninsula Medical School is to find out the truth about such therapies, not necessarily to support them. One can understand Milgrom's confusion about this, when one reads his letter. Leslie Rose BSc CBiol MIBiol FICR MAPM Clinical Science Consultant Conflict of Interest:None declared |
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Edzard Ernst, Peninsula Medical School, Universities of Exeter & Plymouth United Kingdom, Les Rose
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Sir The letter is confusing, ill-informed, pompous and abusive. I showed it to several colleagues who advised me not to respond as it was "rude and not intended to begin an open discussionEand full of pretentious rubbish" I will nevertheless qualify my above statements. Milgrom explains at some length what he does "not intend to debate" with me. I find this confusing. When he finally starts "debating" he discloses an abundance of half-truths and prejudices. For instance, he confuses RCTs with placebo-controlled trials and claims that the RCT has to consider the effects of a treatment "Completely in isolation from the context in which that therapy is given" I would have to fail any first year medical student who puts this on paper -it is demonstrably wrong.(1) Milgrom continues claiming that the placebo effect is "excoriated by the medical orthodoxy." He supplies no evidence for this (or any other) assumption. The reason is that there is no such evidence. Milgrom surpasses himself when he advocates homeopathic arnica to "recover from the heart op more quickly" The most recent systematic review of arnica includes 68 comparisons from 49 clinical trials. It found no proof of arnica's effectiveness, thus confirming the results of several previous reviews.(2) Since over a decade, I have been confronted with the never-ending argument that homeopathy, in some way, defies scientific testing. I have now arrived at the following conclusions. Homeopaths love RCTs as long as they generate the result they want and negate their value if that is not the case. This negation is based either on profound misunderstandings of science, or lack of knowledge, or deliberate obfuscation of the issues at hand. Homeopaths accuse science of being dogmatic while homeopathy frantically adheres to obsolete dogmas. When homeopaths criticise the RCT or other scientific tools, they either fail entirely to put forward any alternative solutions or propose methods which would make even the purest of placebos look like an efficacious intervention. Milgrom's last paragraph adds insult to injury by stating that "honour demands that as a matter of urgency [I] now seriously consider [my] position." This pompous abuse is based on his assumption that I have "Signally failed to support" CAM. Let me just tell you this, Dr Milgrom: my job is to rigorously research CAM(3), not to "support" it by violating the rules of science. E Ernst Complementary Medicine Peninsula Medical School, Universities of Exeter & Plymouth Reference List 1.Ernst E. Randomised clinical trials: unusual designs. Perfusion 2004;17:416-21. 2.LEtke R,.Hacke D. Zur Wirksamkeit des homöopathischen Arzneimittels Arnica montana. Wien Med Wochenschr 2005;155:482-90. 3.Appleton J. Evidence and the future of integrative medicine: an interview with Edzard Ernst, MD, PhD, FRCP, FRCPEd. Integrative Medicine 2003;2. Conflict of Interest:None declared |
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Lionel Milgrom, homeopathic doctor Department of Chemistry, Imperial College, London SW7 2AZ, UK
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Fisher's recent riposte in these pages (1) to the now infamous Lancet meta-analysis of clinical trials comparing homeopathy to allopathy (2), rightly lambastes not only its opaqueness and biased analysis, but the media rhetoric that accompanied it. He concludes his commentary with an entirely reasonable (but plaintive?) call for "open, transparent science" in the best of all possible worlds (i.e., one's dreams), perhaps. For the fact is, mention of the word "Homeopathy" seems to lead to anything but reason from some in the conventional medical/scientific community. Nine months after The Lancet meta-analysis, a remarkable letter appeared in the British newspaper The Times (3). Signed by twelve of the UK's top medical scientists (including oddly enough, the UK's first professor of CAM, Edzard Ernst of the Peninsular Medical School, Exeter University, UK: more of that later), not only did it call for the cessation of CAM funding by the NHS but these eminent professors also accused homeopathy of being "An implausible treatment." Interestingly, this letter appeared shortly after an MHRA interim report on the conduct of the Northwick Park hospital antibody trial that went so disastrously wrong for four of the test subjects, putting them in mortal danger (4). And The Lancet meta-analysis appeared after a sustained thread on negative reports of conventional drugs (e.g., the withdrawal of Vioxx) (5). Conspiracy theorists might be forgiven for thinking they can perceive a pattern developing here. For it could appear that no sooner do the press report some medical blunder or drug withdrawal, then it is followed by an attack on homeopathy/CAMs for being unproven, disproved, or just downright implausible. But then that is conspiracy theorists for you. This time, however, the media response to the eminent professorial letter in The Times was different. Instead of a media chorus condemning homeopathy/CAMs, many commentators seemed somewhat aggrieved that a dozen professors (some semi-retired) should pontificate about what type of healthcare they should or should not have provided by the NHS. Such is the fickleness of The Fourth Estate (6). Media whims aside, there is a serious scientific point to be made here that might help explain why the UK's first professor of CAM, Edzard Ernst put his name to The Times letter. It is true many homeopathic remedies are diluted out of existence and that this seems to violate the dominant biomedical paradigm. In its purest form, this asserts that all life processes and any therapeutic procedure designed to combat disease, are based solely on complex bio-molecular interactions. From the outset therefore, the biomedical paradigm necessarily considers homeopathy implausible. How, it is asked, can a substance diluted out of existence exert any effect, let alone a therapeutic one? Such a question is unanswerable within the straight-jacket of its own paradigm. However, by questioning the very basis of its assumptions, it may be possible to mount not only a defence of homeopathy/CAMs but to begin to see the outlines of a new paradigm that could ultimately lead to a real integration of CAM and conventional medicine (7). First of all, biomedicine takes no account of patient individuality: human beings are not just intelligent bags of chemicals. For another, those same journals that publish high-profile papers dismissing homeopathy as having no effects beyond placebo (2), have also published fully peer-reviewed papers showing that in fact it does (8). And this is not to mention all the many satisfied recipients of homeopathy's benefits world-wide. Perhaps it is merely enough to observe that claiming no substantive evidence base for homeopathy, however bizarre a dozen eminent professors think it to be, is at best disingenuous; at worst an unwarranted slur on the reputations of the many dedicated researchers who are just as committed to the search for truth as those who consider homeopathy implausible. On the other hand, it might well prove instructive to interrogate the status of the double-blind randomised controlled trial (DBRCT) as the only viable source of evidence for or against homeopathy/CAMs, thought worthy of presentation to the court of scientific enquiry. As is well known, the ideology of the DBRCT is embedded deeply in the philosophy of logical positivism (as is much - but by no means all - of science). An implicit assumption of DBRCT methodology is that the effects of a therapeutic intervention may be considered completely in isolation from the context in which that therapy is given. In homeopathy, for example, the remedy is thought of as providing the therapeutic effect, while the extended interview provides the context. Ultimately, this notional separation of therapy and context is the justification for testing a therapy against a (so-called) placebo. Of course, such an ideology fits neatly with the biomedical paradigm and its assertion of a purely molecular basis to disease. In reality, problems arise for the DBRCT when it is realised that this overly simplistic separation of therapy and context is completely artificial. For by admitting patient individuality (as well as simple disease similarity), therapy and context are seen as actually intimately correlated or entangled. Under these circumstances, too rigid adherence to the principles of the DBRCT turns it into a blunt instrument that most likely breaks the correlation between therapy and context (9, 10). This effectively destroys the very therapeutic effect that the DBRCT is trying to investigate. Is it any wonder therefore that DBRCTs deliver such equivocal results when used to test the efficacy of homeopathy and other CAMs? Perhaps the DBRCT could now be seen for what in truth it is. Not the much-vaunted gold-standard of research quality, but the scientific equivalent of Nelson putting a telescope to his blind eye, and far too coarse an experimental procedure with which to investigate homeopathy and CAMs (11). It can be similarly argued that perhaps the DBRCT isn't always appropriate for investigating conventional medicine either. For it is noteworthy that no therapeutic intervention Econventional medicine included - is ever practiced in real life circumstances, according to the positivist strictures of the DBRCT. What price then the edifice that is being erected upon it: so-called "Evidence-based" medicine (12)? Some might argue that all this demonstrates is that, compared to conventional medicine, homeopathy and CAMs are exquisitely 'sensitive' to such intimate therapy/context correlations (although it is well known that context is equally important in conventional medicine) (13). Does this mean that homeopathy is to be summarily dismissed as purely the workings of a "Placebo effect." Actually: no. Very recent advances in our understanding of subtle molecular interactions in water, suggest that the late Jacques Benveniste's 20-year-old assertion about the "Memory of water"(14) might well be right (15, 16). Thus, the therapeutic action of ultra-diluted substances used in homeopathy could well be due to some kind of epitaxial "Formatting" of water's dynamic long-range molecular structure with a remedy's properties. Clearly, this is very much frontier science and likely to be beyond the ken of most CAM or conventional health practitioners, however eminent, as the fundamental atomic and molecular basis of matter has always been taken uncritically for granted. A thorough reading of quantum theory (in particular, quantum field theory) however, could help explain why the primacy of atoms and molecules is actually only an approximation to the truth (17). But the (arguably) more esoteric side of science aside; what of the placebo effect? Why is it so excoriated by the medical orthodoxy when it quite clearly is another (by now, pejorative) name for what is in essence a powerful force for self-healing? If it could be understood and harnessed to help cure our patients, would that not also have substantially positive cost benefits for a cash-strapped NHS buckling under the crushing weight of huge drugs bills? And that is without mentioning the well-documented health and safety issues surrounding drug toxicity and its sometimes life-threatening side-effects (viz, the recent anti-body trials at Northwick Park Hospital). It is also worth reflecting on what the word 'complementary' in CAMs means: that they are supposed to work alongside conventional medicine not replace it (probably a good argument for dropping the word "Alternative" from CAMs) Why? Because CAMs provide versatility and a greater range of tools with which to help treat disease, even if their scientific basis isn't fully comprehended. And such understanding will never even begin to happen while the dead hand of orthodoxy rejects anything out of hand that doesn't fit its current fashionable paradigm, or its flawed testing procedures and the biased way in which they are sometimes deployed (2). In addition, the public need to be credited with some common-sense. They are not going to visit a homeopath if a broken leg needs fixing or triple by-pass surgery is required. But they might have the good sense to try symphytum (in low homeopathic potency; to help accelerate the bone-healing process) and arnica (to aid recovery from the heart op more quickly), regardless of whether narrowly focussed DBRCTs show homeopathy is no better than placebo. And that should be any patient's choice within a properly funded NHS. Which ever way you cut it, there are sound reasons why the NHS should not only continue its current rather paltry funding of homeopathy and CAMs, but should even increase their provision to those patients who clearly want and benefit from them. It is interesting that what the dozen eminent professors overlooked in their letter to The Times is that around 70% of working GPs refer their patients to some kind of CAM therapy. Finally, trusting exclusively in the results of DBRCTs, by its very nature, blinds one to other equally valid research possibilities (18). Under these circumstances, perhaps the UK’s first professor of CAM might well be forgiven for feeling some remorse at being seen to support those who would have the NHS rid itself of the very therapies he was engaged to research. Surely honour demands that as a matter of urgency, he now seriously consider his position? References 1. Fisher P. Homeopathy and The Lancet. Evid Based Complement Alt Med 2006;3(1):145-7. 2. Shang A, Huwiler-MEtener K, Nartey L, Juni P, Dorig S, Sterne LA, et al. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 2005;366:726-732. 3. Baum M, Ashcroft F, Berry C, Born G, Black J, Colquhoun D, Dawson P, Ernst E, Garrow J, Peters K, Rose L, Tallis R. Use of ‘AlternativeEMedicineEin the NHS. The Times, 19/05/07. 4. MHRA Final Report. Investigation into adverse incidents during clinical trials of TGN 1412. 25th May 2006. 5. See BBC News On-line; http://news.bbc.co.uk/1/hi/business/4165836.stm 6. See, for example, Boseley S (Health Editor), Bottom line is that is works, says homeopathic chief. The Guardian, Saturday, 27/05/06, p13. 7. Murcott T. The Whole Story: Alternative Medicine on Trial? Macmillan (New York) 2005. 8. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-843. 9. Weatherley-Jones E, Thompson EA, Thomas KJ, et al. The placebo-controlled trial as a test of complementary and alternative medicine: Observations from research experience of individualised homeopathic treatment. Homeopathy 2004;93:186E. 10. Milgrom LR. Are randomised controlled trials (RCTs) redundant for testing the efficacy of homeopathy? A critique of RCT methodology from the theoretical standpoint of patient- practitioner-remedy (PPR) entanglement. J Altern Complement Med 2005;11:831E38. 11. Milgrom LR. Entanglement, knowledge, and their possible effects on the outcomes of blinded trials of homeopathic provings. J Altern Complement Med 2006;12:271-9. 12. Goodman NW. Who will challenge evidence-based medicine? J R Physicians 1999;33:249-251. 13. University of Minnesota Libraries, Biomedical Library. Understanding research study designs. http://www.biomed.lib.umn.edu/inst/research.pdf 14. Davenas E, Beauvais F, Amara J, Oberbaum M, Robinson B, Miadonna A et al. Human basophil degranulation triggered by very dilute antiserum against IgE. Nature 1988;333:816-818. 15. Belon P, Cumps J, Ennis M. Histamine dilutions modulate basophil activity. Inflamm Res 2004;53:181-183. 16. Roy R, Tiller WA, Bell I, Hoover R. The structure of liquid water; novel insights from materials research; relevance for homeopathy. Mat Res Innovat 2005;9(4):557-608. On line; www.matrix- technology.com 17. Auyung S: How is Quantum Field Theory Possible? New York, Oxford University Press, 1995. 18. See Clinical Research in Complementary Therapies: Principles, Problems, and Solutions, eds Lewith G, Jonas WB, and Walach H. Churchill-Livingston, London, 2003 |
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Paul Lepine, general practitionner Quebec G1K 3B9
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I confirm that both the Lancet and the authors refused to give acces to their raw data, even against the policy of this journal! Worse, the cruded result, even with their flawed methodology is that homeopathy is slightly better than placebo. But, because the number of studies included is so low, the margin of error is great, and encompass the null hypothesis. So, their result is that homeopathy is slightly better than placebo, maybe no better, maybe be moderately better. Far from a sentence of death!! Conflict of Interest:None declared |
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