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Med Sci Monit, 2005; 11(12): SR27-31 The growth of a lie and the end of "conventional" Accepted: 2005.09.28Published: 2005.12.01 Domenico Mastrangelo1, Cosimo Loré2 1 Department of Ophthalmology, University of Siena, Italy2 Department of Forensic Medicine, University of Siena, Italy Source of support: Self fi nancing Throughout its over 200-year history, homeopathy has been proven effective in treating diseases for which conventional medicine has little to offer. However, given its low cost, homeopathy has always represented a serious challenge and a constant threat to the profi ts of drug companies. Moreover, since drug companies represent the most relevant source of funding for biomedical re-search worldwide, they are in a privileged position to fi nance detractive campaigns against home-opathy by manipulating the media as well as academic institutions and the medical establishment. The basic argument against homeopathy is that in some controlled clinical trials (CCTs), compari-son with conventional treatments shows that its effects are not superior to those of placebo. Against this thesis we argue that a) CCT methodology cannot be applied to homeopathy, b) misconduct and fraud are common in CCTs, c) adverse drug reactions and side effects show that CCT meth-odology is deeply fl awed, d) an accurate testing of homeopathic remedies requires more sophis-ticated techniques, e) the placebo effect is no more "plausible" than homeopathy, and its real na-ture is still unexplained, and f) the placebo effect is nevertheless a "cure" and, as such, worthy of further investigation and analysis. It is concluded that no arguments presently exist against home-opathy and that the recurrent campaigns against it represent the specifi c interests of the pharma-ceutical industry which, in this way, strives to protect its profi ts from the "threat" of a safer, more effective, and much less expensive treatment modality.
homeopathy • controlled clinical trials • placebo • homeopathic remedies • clinical research • pharmaceutical industries • law of similars • pharmacogenetics Author's address: Domenico Mastrangelo, M.D., Department of Ophthalmology, University of Siena, Italy, e-mail: mastrangelo@unisi.it Current Contents/Clinical Medicine • SCI Expanded • ISI Alerting System • Index Medicus/MEDLINE • EMBASE/Excerpta Medica • Chemical Abstracts • Index Copernicus Med Sci Monit, 2005; 11(12): SR27-31 medicine. On the other hand, this is the subject of the current dispute between homeopathy and conventional The August 2005 issue of "The Lancet" contains a coordi- nated attack of the medical establishment against homeopa- 4. nevertheless, conventional medicine looks at the placebo thy [1] based on a report according to which a meta-analysis effect as something "real". As a matter of fact, controlled of homeopathic clinical trials would show that homeopa- clinical trials are commonly planned to include a "con- thy is no more effective than placebo. On the force of this, trol" group of patients to be treated with "sugar pills" and two other short but triumphant reports emphatically de- therefore the placebo effect, although mysterious and un- clare the "end of homeopathy" [2] and the fi nal return of explainable, is still an integral part of the culture of con- the light of "truth" in medicine [3]. As professional physi- ventional medicine. It would be good to know why ho- cians and researchers, we would like to distance ourselves meopathy should not be treated in the same way; from the positions expressed in the above-mentioned pa- 5. in spite of all the above, the placebo still has a curative ef- pers and show that this new campaign against homeopathy fect since it refers to people cured by the administration is based on lies rather than truth and represents a step to- of a "sugar pill" instead of an active drug.
ward the end of "conventional" medicine rather than that of homeopathy.
Should we still consider the placebo as a sort of unwanted effect of treatment, or would it perhaps be wiser and more THE EVER-CHANGING "TRUTHS OF "CONVENTIONAL" advisable to try to better understand its nature and, even- tually, exploit it to reduce the incidence of adverse or fatal drug reactions [7]? In his "Lectures on Homeopathic Philosophy" [4], James Tayler Kent, one of the founders of homeopathy in the "CURE THE INDIVIDUAL, NOT THE DISEASE!" (S.F. United States, gives us an extraordinary picture of conven- HAHNEMANN) (AND RESPECT HIM AS MUCH AS YOU CAN!) tional medicine: ""…hence we may see, in this century, a medical convention of a thousand physicians who rely en- It is a well-known fact that the US Institutes of Health (NIH) tirely upon experience, at which one will arise and relate long since created the National Center for Complementary of his experience, and another will arise and tell his expe- and Alternative Medicine (NCCAM) dedicated to exploring rience, and the talkers of that convention continue to de- complementary and alternative healing practices in the con- bate, and no two talkers agree. When they have fi nished text of rigorous science, training complementary and alter- they compare their experiences and that which they set- native medicine (CAM) researchers, and disseminating au- tle upon they call science, no matter how far they may be thoritative information to the public and professionals [8]. from the truth. Next year they come back and they have Although this may not necessarily be an argument in favor different ideas and have had different experiences and of homeopathy, it would appear at least bizarre to the aver- they then vote out what they voted in before….This is the age US citizen that his/her income is being used to fi nance wrong direction. The science of medicine must be built on NCCAM research on placebo or other useless drugs. On true foundation….Old-fashioned medicine denies princi- the other hand, it is also very well known that the number ple and law, calls its system the "medicine of experience", of people resorting to homeopathy is around 500 million and hence its doctrines are kaleidoscopic, changing every year and worldwide [9], which is quite a fi gure to ponder and inves- never appearing twice alike"".
tigate for a type of medicine which is no more effective than placebo. Overall, Dr. Shang and colleagues, having come to How true this last sentence is can be easily appreciated if the conclusion that homeopathy is not superior to placebo, we consider that in 1994 [5] and 1997 [6] "The Lancet" it- do not seem to give much thought to the fact that thousands self published two important papers in which, using argu- of medical professionals, hundreds of institutions, and, as al- ments and methods identical to those reported by Shang ready mentioned, hundreds of millions of individuals world- [1], the authors reached the conclusion that homeopathy wide believe in homeopathy, use it, and work on it. Should is more effective than placebo. Given the ever-changing nature we consider them all foolish, idiots, or visionaries? We pre- of truth in conventional medicine, would it not be wiser to fer to leave the burden of the answer to Dr. Shang and col- wait for the next Lancet report on this subject before pro- leagues [1]. It is a fact, however, that with this new paper, claiming the end of homeopathy [3]? conventional medicine attempts once again to confi rm its presumed supremacy not by demonstrating it with facts, but WHAT'S WRONG WITH THE PLACEBO? rather by dismissing anything else as false or useless.
Detractors of homeopathy worldwide compare it to place- Since its early days, homeopathy has dealt with sick individ- bo to implicate its uselessness. However, for a more accu- uals rather than diseases; the respect of the individual is, rate evaluation of the placebo effect and its signifi cance in therefore, the cornerstone of any homeopathic treatment. conventional medicine, a few signifi cant facts appear wor- Apparently, the same does not apply to conventional med- thy of consideration: icine, which continues to use its "congenital" arrogance 1. the real nature of the placebo effect is unknown; and lack of respect for anyone else's opinions and beliefs. 2. it has never been explained in terms of interactions be- No wonder, therefore, that an ever-increasing number of tween molecules and hence must be based on "immate- patients resort to homeopathy as the main treatment for rial" interactions, if any (something like the "vital force" their ailments, and this number continues to increase in spite of the violent campaigns, inspired and largely fi nanced 3. "immaterial", and hence non-measurable, interactions by multinational drug companies, against "complementa- are commonly discarded as unproven by conventional ry" medicines.
Med Sci Monit, 2005; 11(12): SR27-31 Mastrangelo D et al – The growth of a lie and the end of "conventional" medicine THE CONTROLLED CLINICAL TRIAL: THE APOCRYPHAL GOSPEL HOMEOPATHY AND CCT: INVESTIGATING GALAXIES WITH OF "CONVENTIONAL" MEDICINE MICROSCOPES (OR CELLS WITH TELESCOPES) The Lancet campaign against homeopathy was launched by It is known that pharmaceutical companies look at the CCT experts on controlled clinical trials and it is therefore based as the gold standard ("gold" in this circumstance having on the unproven assumption that the CCT methodology is re- apt symbolic value) for drug testing, although, as we have liable, repeatable, accurate, and infallible. This is simply not seen, this is an unrealistic and unscientifi c procedure, heav- true. In 1991, Dr. Harris L. Coulter [10], in his book "The ily compromised by economic interests, dishonesty, fraud, Controlled Clinical Trial: An Analysis", reported that "CCT negligence, and many other kinds of wrongdoing. But what cannot guarantee drug safety and effi cacy because the theo- is really wrong with CCT methodology and indicates that retical requirements of CCT are both unrealistic and unscien- no comparison can be made between conventional and ho- tifi c". This point of view was more recently confi rmed by sci- meopathic medicine based on it? A practical example will entists who reported that there is no evidence for large-scale clarify this crucial issue. Let us suppose that a pharmaceuti- CCTs other than the vested interests of the pharmaceutical cal company has to test the effi cacy (and safety) of the new industry to defy sound arguments which demonstrate that drug "ASA" (acetylsalicylic acid) in the treatment of fever. the methodology of these studies is deeply fl awed [11]. As According to CCT methodology, one would simply select a a matter of fact, CCT methodology is based on the unrealis- group of patients with fever, assign them, through the proc- tic and unscientifi c assumption that any given disease shows ess of "randomization", to either the active drug (ASA) or the same characteristic features in different individuals and, a placebo treatment, and look for differences in response. therefore, can be treated in the same way. In the real world, Hence: one disease (or symptom) – one treatment.
however, there is no such thing as two identical individuals. Dr. Coulter therefore concludes: "The CCT can never tell a Homeopathy, in contrast, teaches us that fever may mani- doctor how a given patient will react to a given drug at any fest differently in different individuals and it may depend given time". The relevance of individual differences in drug on several diverse causes. Therefore, homeopathy will use treatment is highlighted by pharmacogenetics, a relatively new Aconitum to treat a fever with sudden onset, Arsenicum Album branch of conventional medicine, confi rming that this point for a feverish, anxious, and fi dgety child, Belladonna for a of view does not belong to homeopathy only [12,13]. On the feverish child who has chills and a fl ushed and heated face other hand, the unpredictability of the individual response and body, Bryonia for fever with strong thirst, Chamomilla to drugs is confi rmed by countless reports of deaths from ad- for fever associated with teething, Ferrum Phosphoricum for verse drug reactions, leading US magazines and newspapers moderate fever, Gelsemium for the child who sustains a fe- to claim that "the FDA approves deadly drugs, and delays life- ver and whose whole body feels achy and fl ushed, Mercurius saving therapies" [14], or prestigious scientifi c journals to de- solubilis for the feverish child with offensive-smelling breath, clare that it is time for the creation of a new black box warn- body, stool, and/or urine, etc. [22–25], continuing with a ing and withdrawals for prescription medications [15].
list of tens or maybe hundreds of different remedies, each with a single and extremely specifi c indication. It is easy to According to Dr. Coulter, the CCT has become popular see that limiting the homeopathic treatment to one rem- primarily for political reasons [16]. Given its costs, it is edy for a single indication, with no further specifi cation, used by pharmaceutical companies to limit competition would inevitably end up destroying the essence of home- and raise the costs of medications to the public. But mo- opathic treatment itself, thus resulting in ineffective treat- nopolistic objectives are not the only built-in fraud feature ment. It is also clear that the current CCT methodology of the CCT. Fraud in the safety testing of drugs is a strong is still largely imperfect and cannot be applied to an em- likelihood, since investigators may receive more than one inently non-speculative, empirical, and pragmatic science million dollars annually (in 1991!) from their testing pro- such as homeopathy.
grams. Among the most frightful examples of dishonesty, fraud, negligence, and other kinds of wrongdoing in clinical IS THERE ANY PLACEBO EFFECT IN VETERINARY trials, the author mentions the trials of a drug designed to prevent kidney transplant rejection which led to 85 deaths among the 650 patients participating, and not one of these Although controversial, homeopathy has gained large pop- deaths was reported to the Food and Drug Administration ularity in veterinary medicine [26] and, as has been recent- (FDA). This trend towards fraud in CCTs has not changed ly reported, its intrinsic effi cacy is sometimes so convincing very much, but rather increased in recent years: as report- that evidence against it, highly desired by the veterinary ed by Nature [17] the attorney-general of New York State medical establishment, is largely disregarded by its routine sued GlaxoSmithKline (GSK) for allegedly suppressing neg- users [27]. Clinical and laboratory evidence suggests that ative results of trials that tested the safety and effi cacy of homeopathy is effective beyond any reasonable doubt, as four different studies on Paxil. Fraud in clinical research recently demonstrated, for example, by controlled clinical and CCTs has been reported by some important scientifi c trials investigating the immunomodulating effect of water and medical journals, such as the British Medical Journal extracts of Calendula Offi cinalis in animals [28], but appar- [18], Science [19], the Journal of Internal Medicine [20], ently there is no convincing evidence for the supporters of and The Lancet itself [21]. With this picture in mind, the the placebo effect of homeopathic treatment.
reader may now evaluate more objectively the clinical and scientifi c relevance of the methodology behind CCTs and However, the presumed or understood existence of a place- fi nally understand why large collections of such investiga- bo effect in animals still deserves a few words of comment. tions, as performed in meta-analyses, would only lead to con- The placebo effect is considered a psychobiological phe- fusing, uncertain, and misleading conclusions.
nomenon that can be due to different mechanisms, which Med Sci Monit, 2005; 11(12): SR27-31 include, among others, the expectation of clinical benefi ts. a. under the sponsorship of pharmaceutical companies As recently reported, placebo research underscores the in- and because of it conceal year after year the hecatomb stability of the human mind and its somewhat dangerous of deaths, adverse drugs reactions, and similar disasters tendency to be manipulated not only in a positive (place- from the public view by referring and publishing only the bo), but also in a negative sense (nocebo), depending on positive results of their controlled clinical trials; the individual psychological traits and concerns and the on- b. by using CCT methodology contribute to the FDA ap- going psychosocial context [29]. Have animals the power to proval of prescription drugs such as Rezulin, Lotronex, reason whether a given treatment is going to work or not? Propulsid, Redux, Pondimin, Duract, Seldane, Hismanal, Can any animal be aware of the treatment to be adminis- Posicor, Raxar [34], just to mention a few examples, that tered to it? Can any animal be skeptical about an alterna- have had to be withdrawn from the market since 1997 be- tive medical approach, as a person might? It is evident to cause of harmful and potentially lethal side effects; us that homeopathy's effi cacy in successfully treating ani- c. in spite of all this information continue (or pretend) to mals goes a long way to debunking the claims of those who ignore that adverse drug reactions are between the fourth believe that its effects are "only placebo" [30].
and sixth leading cause of death in the USA [35] and that the real fi gure is largely underestimated [32], thus imply- …MORE ABOUT THE "TRUTH" IN MEDICINE ing that the true amount of human lives annually sacri-
fi ced for the sake of the business of drug companies must
In the article entitled: "Homeopathy: the growth of truth" be kept concealed from the public.
[3], Dr. Vandenbrouke reminds us that "the ultimate proof" of the effi cacy of conventional medicine "is that it makes CONCLUDING REMARKS: "CUI PRODEST" (WHO'S AFRAID progresses in preventing, alleviating and curing disease ever more effi ciently". It is very diffi cult to share such enthusiasm and trust in conventional medicine if we look, for example, Any open-minded physician should reasonably welcome at the yearly tribute paid in human lives to the use (and often new treatments such as homeopathy which show effective- misuse) of toxic drugs approved for use in man after fraudu- ness and lack of toxicity. The same should apply to patients lent or misconducted "controlled" clinical trials. Estimates re- who, with "unconventional" medicine, can fi nally fulfi l their port a death toll from adverse drug reaction of 108,000 in the need for less toxic drugs, individualized treatments, and a United States during the year 1996 alone [31], but it is clear closer relationship with their doctors. But what about the that this fi gure must be much higher [32]. Moreover, since drug companies? The growing popularity of homeopathy medical research worldwide is in the hands of drug compa- and complementary medicine represents the most serious nies, it is very hard to fi gure out how and why they should be- challenge and is a constant threat to their multi-billion-dol- come involved in any kind of disease prevention campaign, lar business. No wonder, therefore, that they would invest their business being, as it is, strictly dependent on the perpet- considerable amounts of money in detractive campaigns uation of human sickness [33]. Finally, while it is clear that against homeopathy, even if with poor results.
conventional medicine can and does alleviate symptoms, it is also evident that very often it cannot go any further than Given all the above, we believe that no bold and honest per- that. Lifelong treatments with corticosteroids, pain killers, son, whether physician, scientist, or researcher, should con- antidepressants, antihypertensive, anti-diabetics, antibiotics, tinue to support the drug industry and its businesses, at least and chemotherapeutic agents offered to patients by conven- not until it becomes clear to all that medicine is one, and tional medicine do not exactly correspond to the idea behind that its only and higher scope is curing of the sick.
the concept of the curative power of medicines.
…AND MORE ABOUT THE "END" OF HOMEOPATHY 1. Shang A, Huwiler-Muntener K, Nartey L et al: Are the clinical The anonymous author of the article "The End of effects of homoeopathy placebo effects? Comparative study of place- Homeopathy" recommends: "Now doctors need to be bo-controlled trials of homoeopathy and allopathy. Lancet, 2005; 366: 726–32 bold and honest about homeopathy's lack of benefi t, and 2. No Authors: The end of homeopathy. Lancet, 2005; 366: 691–92 with themselves about the failing of modern medicine to 3. Vandenbroucke JP: Homeoapthy and the growth of truth. Lancet, address patients' needs for personalised care". As we have 2005; 366: 691–92 shown above, the "failing of modern medicine to address 4. Kent JT: Lectures on Homeopathic Philosophy. B. Jain Publishers patients' needs for personalised care" largely depends on Ltd, 1999; 41–46 ignorance, arrogance, and disrespect for others' opinions 5. Reilly D, Taylor MA, Beattie NGM et al: Is evidence for homoe- and beliefs, so typical of conventional medicine and exem- opathy reproducible? Lancet, 1994; 344: 1601–6 plarily represented in the last Lancet paper on homeop- 6. Klaus L, Clausius N, Ramirez G et al: Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled athy. As for the "boldness" and "honesty" doctors should trials. 1997; 350: 834–43 adopt in reporting homeopathy's presumed lack of bene- 7. Di Blasi Z, Reilly D: Placebos in medicine: medical paradoxes fi t, we would like to remind the reader that the effective- need disentangling. BMJ, 2005; 330(7481):45 ness (and safety) of homeopathy is demonstrated beyond any reasonable doubt by the number of patients resorting 9. Trivieri L, Amderson JW eds: Alternative Medicine: The Defi nitive to it and the countless cures reported worldwide for about Guide. Celestial Arts-Berkeley, 2002; 270 two hundred years, with no side effects. The same, obvious- ly, does not apply to conventional medicine, and this is the 11. Penston J: Large-scale randomised trials – a misguided approach to clin- reason why we would rather like to recommend boldness ical research. Med Hypotheses, 2005; 64(3): 651–57 and honesty to all those physicians who: Med Sci Monit, 2005; 11(12): SR27-31 Mastrangelo D et al – The growth of a lie and the end of "conventional" medicine 12. Shah RR: Pharmacogenetics in drug regulation: promise, potential and pitfalls. Philos Trans R Soc Lond B Biol Sci. 2005; 360(1460): 25. Kent JT: Repertory of the Homeopathic Materia Medica. B. Jain Publishers LTD. Reprint edition – 2003 13. Hiratsuka M, Sasaki T, Mizugaki M: Genetic testing for pharmacogenet- 26. Hektoen L: Review of the current involvement of homeopathy in vet- ics and its clinical application in drug therapy. Clin Chim Acta. 2005; erinary practice and research. Vet Rec, 2005; 157(8): 224–29 [Epub ahead of print] 27. Hektoen L: Investigations of the motivation underlying Norwegian dairy farmers' use of homoeopathy. Vet Rec. 2004; 155(22): 701–7 15. Lasser KE, Allen PD, Woolhandler SJ et al: Timing of new black box 28. Barbour EK, Sagherian V, Talhouk S et al: Evaluation of homeopa- warnings and withdrawals for prescription medications. JAMA. 2002; thy in broiler chickens exposed to live viral vaccines and admin- 287(17): 2215–20 istered Calendula offi cinalis extract. Med Sci Monit, 2004; 10(8): 16. Trivieri L, Anderson JW eds: Alternative Medicine: The Defi nitive Guide. Celestial Arts, 2002; 44–59 29. Coiloca L, Benedetti F: Placebos and painkillers: is mind as real as mat- 17. Nature. 2004; 429(6992): 589 ter? Nature Reviews Neurosciences, 2005; 6: 545–52 18. White C: Suspected research fraud: diffi culties of getting at the truth. 30. Trivieri L, Anderson JW eds: Alternative Medicine: The Defi nitive Guide. BMJ, 2005; 331(7511): 281–88 Celestial Arts, 2002; 274 19. Hangmann N: Scientifi c misconduct: cancer researchers sacked for al- leged fraud. Science, 2000; 287(5460): 1901–2 32. Chyka PA: How many deaths occur annually from adverse drug reac- 20. Sleight P: Where are clinical trials going? Society and clinical trials. J tions in the United States? Am J Med, 2000; 109(2): 122–30 Intern Med, 2004; 255(2): 151–58 21. Hoeksema HL, Troost J, Grobbee DE et al: Fraud in a pharmaceutical trial. Lancet, 2000; 356(9243): 1773 35. Lazarou J, Pomeranz BH, Corey PN: Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies. JAMA, 1998; 279: 1200–5

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