Because practitioners of complementary21 and traditional medicine are severely critical of modern
19 Royal Commission on Civil Liability and Compensation for Personal Injury 1978 HMSO, London: Cmnd. 7054. Although the Commission considered compensation for death and personal injury suffered by any person through manufacture, supply or use of products, i.e. all goods whether natural or manufactured, and included drugs and even human blood and organs, it made no mention of tobacco and alcohol.
• New unliccnccd drugs undergoing clinical trial in small numbers of subjects (healthy or patient volunteers): the developer should be strictly liable for all adverse effects.
• New unliccnccd drugs undergoing extensive extensive trials in patients who may reasonably expect benefit: the producer should be strictly liable for any serious effect
• New drugs after licencing by aft official body: liability for serious injury should be shared with the community, which is cxpccted to benefit from new drugs.
• Stondord drugs in day-to-day therapeutics:
1. there should be a no-fault scheme, operated by or with the assent of government, that has authority, through tribunals to decide cases quickly and to make awards.This body would have authority to reimburse itself from others — manufacturer, supplier, prescriber — wherever that was appropriate. (The basic funding of the scheme would be via a levy on all manufacturers of medicinal products.) An award must not have to wait on the determination of prolonged, vexatious, adversarial, expensive court proceedings.
2. Patients would be compensated where:
causation was proven on 'balance of probability'10 the injury was serious — the event was rare and remote and not reasonably taken into account in making the decision to treat.
drugs, and because they use drugs according to their own special beliefs, it is appropriate to discuss drug use in complementary medical systems here.
20 This is the criterion for (UK) civil law, rather than 'beyond reasonable doubt', which is the criterion of criminal law.
21 The term complementary seems to make a less ambitious claim than alternative medicine, and is preferred. The definition adopted by the Cochrane Collaboration is: 'Complementary and alternative medicine (CAM) is a broad domain of healing resources that accompanies all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.'
Public disappointment that scientific medicine can neither guarantee happiness nor wholly eliminate the disabilities of degenerative diseases in long-lived populations, as well as the fact that drugs used in modern medicine can cause serious harm, naturally lead to a revival of interest in alternatives that alluringly promise efficacy with complete safety. These range from revival of traditional medicine to adoption of the more modern cults.22
A proposition belongs to science if we can say what kind of event we would accept as refutation (and this is easy in therapeutics). A proposition (or theory) that cannot clash with any possible or even conceivable event (evidence) is outside science, and this in general applies to cults: everything is interpreted in terms of the theory of the cult; the possibility that the basis of the cult is false is not entertained. This appears to be the case with medical cults, which join Freudianism, and indeed religions, as outside science (after Karl Popper). Willingness to follow where the evidence leads is a distinctive feature of conventional scientific medicine.
22 A cult is a practice that follows a dogma, tenet or principle based on theories or beliefs of its promulgator to the exclusion of demonstrable scientific experience (definition of the American Medical Association). Scientific medicine changes in accord with evidence obtained by scientific enquiry applied with such intellectual rigour as is humanly possible. But this is not the case with cults, the claims for which are characterised by absence of rigorous intellectual evaluation and unchangeability of beliefs. The profusion of medical cults prompts the question why, if each cult has the efficacy claimed by its exponents, conventional medicine and indeed the other cults are not swept away. Some practitioners use conventional medicine and, where it fails, turn to cult practices. Where such complementary practices give comfort they are not to be despised, but their role and validity should be clearly defined. No community can afford to take these cults at their own valuation; they must be tested, and tested with at least the rigour required to justify a therapeutic claim for a new drug. It is sometimes urged in extenuation that traditional and cult practices do no harm to patients, unlike synthetic drugs. But even if that were true (which it is not), investment of scarce resources in delivering what may be ineffective, though sometimes pleasing, experiences, e.g. dance therapy, exaltation of flowers, and the admittedly inexpensive urine therapy, means that resources are not available for other desirable social objectives, e.g. housing, art subsidies, medicine. We do not apologise for this diversion to consider medical cults and practices, for the world cannot afford unreason, and the antidote to unreason is reason and the rigorous pursuit of knowledge, i.e. evidence-based medicine.
A scientific approach does not mean a patient must be treated as a mere biochemical machine. It does not mean the exclusion of spiritual, psychological and social dimensions of human beings. But it does mean treating these in a rational manner.
Traditional or indigenous medicinal therapeutics has developed since before history in all societies. It comprises a mass of practices varying from the worthless to highly effective remedies, e.g. digitalis (England), quinine (South America), reserpine (India), atropine (various countries). It is the task of science to find the gems and to discard the dross,23 and at the same time to leave intact socially valuable supportive aspects of traditional medicine.
Features common to complementary medicine cults are absence of scientific thinking, naive acceptance of hypotheses, uncritical acceptance of causation, e.g. reliance on anecdote, assumption that if recovery follows treatment it is due to the treatment, and close attention to the patient's personal feelings. Lack of understanding of how therapeutic effects may be measured is also a prominent feature. It is useful to list some common false beliefs of its practitioners:
• That synthetic modern drugs are toxic, but products obtained in nature are not.24
• That traditional (prescientific) medicines have special virtue.
• That scientific medicine will accept evidence that remedies are effective only where the mechanism is also understood.
• That scientific medicine recognises no form of evaluation other than the strict randomised controlled trial.
• That collection and formal analysis of data on
23 Traditional medicine is being fostered particularly in countries where scientific medicine is not accessible to large populations for economic reasons, and destruction of traditional medicine would leave unhappy and sick people with nothing. For this reason governments are supporting traditional medicine and at the same time initiating scientific clinical evaluations of the numerous plants and other items employed, many of which contain biologically active substances. The World Health Organization is supportive to these programmes.
therapeutic outcomes, failures as well as successes, is inessential.
• That scientific medicine rests on acceptance of rigid and unalterable dogmas.
• That, if a patient gets better when treated in accordance with certain beliefs, this provides evidence for the truth of these beliefs (the post hoc ergo propter hoc25 fallacy).
Exponents often state that comparative controlled trials of their medicines versus conventional medicines are impracticable because the classic double-blind randomised controlled designs are inappropriate and in particular do not allow for the individual approach characteristic of complementary medicine. But modern therapeutic trial designs can cope with this. There remain extremists who contend that they understand scientific method, and reject it as invalid for what they do and believe, i.e. their beliefs are not, in principle, refutable. This is the position taken up by magic and religion where subordination of reason to faith is considered a virtue.
Complementary medicine particularly charges that conventional medicine seriously neglects patients as whole integrated human beings (body, mind, spirit) and treats them too much as machines. Conventional practitioners may well feel uneasily
24 Herbal teas containing pyrrolidizine alkaloids (Senecio, Crotalaria, Heliotropium cause serious hepatic veno-occlusive disease. Comfrey (Symphitum) is similar but also causes hepatocellular tumours and haemangiomas. Sassafras (carminative, antirheumatic) is hepatotoxic. Mistletoe (Viscum) contains cytotoxic alkaloids. Ginseng contains oestrogenic substances which have caused gynaecomastia: long-term users may show 'ginseng abuse syndrome' comprising CNS excitation; arterial hypotension can occur. Liquorice (Glycyrrhiza) has mineralocorticoid action. An amateur 'health food enthusiast' made himself a tea from 'an unfamiliar [to him] plant' in his garden: unfortunately this was the familiar foxglove (Digitalis purpurea): he became very ill but happily he recovered. Other toxic natural remedies include lily of the valley (Convallaria) and horse chestnut (Aesculus). 'The medical herbalist is at fault for clinging to outworn historical authority and for not assessing his drugs in terms of today's knowledge, and the orthodox physician is at fault for a cynical scepticism with regard to any healing discipline other than his own' (Penn R G 1983 Adverse Drug Reaction Bulletin: no 102).
25 Latin: after this, therefore on account of this.
that there has been and still is truth in this, that with the development of specialisation some doctors have been seduced by the enormous successes of medical science and technology and have become liable to look too narrowly at their patients where a much broader (holistic) approach is required. It is evident that such an approach is likely to give particular satisfaction in psychological and psychosomatic conditions for which conventional doctors in a hurry have been all too ready to think that a prescription meets all the patients' needs.
Complementary medicine does not compete with the successful mainstream of scientific medicine. Users of complementary medicine commonly have chronic conditions and have tried conventional medicine but found that it has not offered a satisfactory solution, or has caused adverse effects. A survey estimated that about 20% of the UK population had consulted a complementary practitioner in the previous year (in Germany the figure exceeds 60%).26 Usage rises sharply among those with chronic, relapsing conditions such as cancer, multiple sclerosis, HIV infection, psoriasis and rheumatological diseases. The following will suffice to give the flavour of homoeopathy, the principal complementary medicine cult involving medicines, and the kind of criticism with which it has to contend.
Homoeopathy27 is a system of medicine founded by Samuel Hahnemann (German physician: 1755-1843) and expounded by him in the Organon of the rational art of healing.28 Hahnemann described his position:
After I had discovered the weakness and errors of my teachers and books I sank into a state of sorrowful indignation, which had nearly disgusted me with the study of medicine. I was on the point of concluding that the whole art was vain and incapable of improvement. I gave myself up to solitary reflection, and resolved not to terminate
26 Ernst E 2000 The role of complementary and alternative medicine. British Medical Journal 32:1133-1135.
27 Greek: homos: same; patheia: suffering.
281810: trans. Wheeler C E 1913: Dent, London.
my train of thought until I had arrived at a definite conclusion on the subject.29
By understandable revulsion at the medicine of his time, by experimentation on himself (a large dose of quinine made him feel as though he had a malarial attack) and by search of records he 'discovered' a 'law' that is central to homoeopathy (and from which the name is derived):30
Similar symptoms in the remedy remove similar symptoms in the disease. The eternal, universal law of Nature, that every disease is destroyed and cured through the similar artificial disease which the appropriate remedy has the tendency to excite, rests on the following proposition: that only one disease can exist in the body at any one time.
In addition to the above, he 'discovered' that the effect of drugs but not of trace impurities is potentiated by dilution (provided the dilution is shaken correctly, i.e. by 'succussion', even to the extent that an effective dose may not contain a single molecule of the drug. It has been pointed out29 that the 'thirtieth potency' (1 in 1060), recommended by Hahnemann, provided a solution in which there would be one molecule of drug in a volume of a sphere of literally astronomical circumference. That a dose in which no drug is present (including sodium chloride prepared in this way) can be therapeutically effective is explained by the belief that there is a spiritual energy diffused throughout the medicine by the particular way in which the dilutions are shaken (succussion) during preparation, or that the active molecules leave behind some sort of 'imprint' on solvent or excipient.31 The absence of potentiation of the inevitable contaminating impurities is attributed to the fact that they are not incorporated by serial dilution. It also seems that solid formulations may be inactivated during dispensing, by machine or hand counting carried out incorrectly. Thus, writes a critic:
2" Hahnemann S1805 Aesculapius in the balance. Leipsic.
30 Clark AJ 1937 General Pharmacology Hefter's Handbuch. Springer, Berlin.
31 Homoeopathic practitioners repeatedly express their irritation that critics give so much attention to dilution. They should not be surprised considering the enormous implications of their claim.
We are asked to put aside the whole edifice of evidence concerning the physical nature of materials and the normal concentration-response relationships of biologically active substances in order to accommodate homoeopathic potency.32
But no hard evidence that tests the hypothesis is supplied to justify this, and we are invited, for instance, to accept that sodium chloride merely diluted is no remedy, but that 'it raises itself to the most wonderful power through a well-prepared dynamisation process' and stimulates the defensive powers of the body against the disease.
Thus pharmacologists have felt that in the absence of conclusive evidence from empirical studies that homoeopathic medicines can reproducibly be shown to differ from placebo, there is no point in discussing its hypotheses. But empirical studies can be made without accepting any particular theory of causation; nor should the results of good studies be disregarded just because the proposed theory of action seems incredible or is unknown. A meta-analysis of 186 double-blind and/or randomised placebo-controlled trials of homoeopathic remedies found 89 had adequate data for analysis. The authors concluded that their results 'were not compatible with the hypothesis that the clinical effects are completely due to placebo' but also found 'insufficient evidence from these studies that homoeopathy is clearly efficacious for any single clinical condition'.33
Conclusion. There is a single fundamental issue between conventional scientific medicine and traditional and complementary medicine (though it is often obscured by detailed debates on individual practices); the issue is: what constitutes acceptable evidence, i.e. what is the nature, quality and interpretation of evidence that can justify general adoption of modes of treatment and acceptance of hypotheses? In the meantime, we depend on the accumulation of evidence from empirical studies to justify the allocation of resources for future research.
32 Cuthbert A W1982 Pharmaceutical Journal 15 May: 547.
33 Linde K et al, 1997 Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 350: 834-843.
PRESCRIBING, CONSUMPTION AND ECONOMICS
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