SAFETY PROFILE FOR HOMOEOPATHY REFUTED
"A common fallacy" within homoeopathic advocacy is that "homoeopathy is both safe and effective". Director of the Office of Complementary Medicine, US National Institutes of Health, Dr Wayne Jonas, author of a popular treatise on homoeopathy (1), reluctantly increasingly a sceptic in the light of developing research, in an article titled "Safety in homoeopathy" explains that "The conventional reaction is that they are all placebo, can have no specific effects at all; that is, either therapeutic or toxic, and therefore are at least harmless. This attitude is reflected in the approach taken by the US Food and Drug Administration, that generally classifies homoeopathic preparations as over-the-counter drugs approved for sale without claims of effectiveness, and exempt from the standard toxicity and safety testing required of other medications". (2)
Jonas: "If recent evidence indicating that homoeopathic medications may not work in identical fashion to placebo, are substantiated, and they produce specific effects, then the possibility exists that they also may produce specific adverse effects and their evaluation will require the same assessment of risk benefit ratio as any other intervention". (2) My thesis is that homoeopathic treatment bears definite risk that a patient with a serious non self-limiting condition will actually be receiving no effective extraneous treatment, and is also at iatrogenic risk. Jonas, corroborates: "treatment with ineffective therapy, will result in unnecessary progression of disease and adverse effects. Some homoeopaths claim that there is a duration of action from certain potencies, even up to a year after a single dose. The author has seen cases in which individuals with chronic illness, such as gingivitis and gall bladder disease, have been told to wait for the full duration of action of the remedy, resulting in continued suffering". (2) Similar records exist involving children, eg treated for atopic dermatitis, pneumonia, cervical strep-lymphadenitis, and acute lymphatic leukaemia. (3)
Avogadro's law states that above a dilution of 12C/24D(X), there is unlikely to be a single molecule of the original substance. As a general rule, low potencies could, according to the "pharmaco-logical" or "immuno-logical" potential of the starting substance, produce a measurable effect, but with the exception of toxic agents, allergens and disease organisms or innoculants (nosodes/isopathy), higher potencies are unlikely to exert other than allergenic, let alone claimed beneficial effects. Loscher concurs: "Homoeopathic drugs may exert pharmacodynamic, including toxic effects at low dilutions of D0-D6. There is no scientific effect of higher dilution except for substances with high toxic potential". (4) Low potencies and especially the complexes with indications, respectively violate 1, 2 and 3 of Hahnemann’s Three Laws of Homoeopathy.
Definitive study of the adverse effects of homoeopathic remedies have not been conducted but even if they are merely placebos, adverse reactions (known as "nocebo effects") can clearly still ensue from their use. (5) Professor Edzard Ernst, Chair of Complementay Medicine at Exeter University (UK), believes that "The assumption that homoeopathy, even though ineffective, is free of risks, is questionable, since side-effects and complications associated with homoeopathy have been reported in the literature, and on the basis of which data the notion of totally risk-free homoeopathy is untenable". (6) Loscher and Richter, Institute of Pharmacology, Toxicology and Pharmacy in Hannover, Germany, conducting a critical evaluation of the most important homoeopathic drugs concluded:"Several of the marketed homoeopathic drugs for treatment of animals represent a risk for both the animals and the consumer of food produced from animals". (7)
Aulas conducted an extensive literature search, reported and recommended: "Little progress has been made in documenting the side-effects of homeopathic preparations. Serious adverse effects have been reported with low dilutions <4C/8D(X) given parenterally or orally. Homeopathic preparations should not be used to treat serious diseases when other drugs are known to be both effective and safe. Regardless of the condition treated, homoeopathic dilution below 5C/10D(X) and especially low decimal dilutions must not only be considered as having no proven efficacy but also as having potential dangers". (8) Products misbranded as homoeopathics may also work only because of adulteration with therapeutic levels of eg steroidal drugs. (9)
Because it is not mandatory, yet is actionable, homoeopathic side-effects are rarely sought and/or reported. Homoeopathy employs numerous extremely toxic substances supposedly in infinitesmal amounts. However, commercial remedies have been found to contain toxic doses. By way of one example: "In order to test the widely held assumption that homeopathic medicines contain negligible quantities of their major ingredients, six such medicines labelled in Latin as containing arsenic were purchased over the counter and by mail order and their arsenic contents measured. Values determined were similar to those expected from label information in only two of six and were markedly at variance in the remaining four. Arsenic was present in notable quantities in two preparations. No warnings appeared on the labels". (10) "Acute pancreatitis following administration of a complex homoeopathic remedy" has been reliably reported. (11)
Montoya-Cabrera reported: "an infant with diaper dermatitis and mild respiratory and enteral infections, treated with a homeopathic mercurial medicine: Mercurius 6a (cinnabar dilute 1 x 10000000), thereafter became seriously ill with exacerbation and dissemination of the dermatitis as well as irritability and albuminuria. Mercury urine levels were 60 micrograms/L (reference less than 10 micrograms/L)". An antidote chelating agent was administered. The clinical conditions improved and urinary levels of mercury decreased to normal values. The researchers concluded that "homeopathic medicaments should be recognised as potentially harmful substances". (12) Stevens reported: "a case of human thallotoxicosis, confirmed by feces analysis, caused by the taking of a homoeopathic preparation". The patient rapidly developed symptoms of thallium poisoning. Antidote treatment with Prussian blue resulted in recovery. (13)
Prescrire International report that Austrian
authors (14) reported adverse reactions in three patients. "The first, recovering from a 'flu like' syndrome, took a homeopathy preparation containing compounds in 4 D(X). After three days he developed pruritis with palmar and plantar oedema followed by erythroderma. The second developed a measles-like skin rash after taking a complex botanical homeopathic mixture. The third developed anaphylactic shock requiring intensive care after taking homeopathic preparations of pollens. Rechallenge with the associated remedy was positive in all cases, and show that homeopathic preparations can induce immuno-allergic reactions without having to be injected". (8) This is confirmed by eg refs (15) & (16). Also Apis (crushed bee)(source Hanheman Homoeopathy Clinic), has resulted in worsening episodes of back-pain, spreading to other parts of the complainant’s body; and both Hepar sulph (source unstated) and Silicea, (source Dolisos), has resulted in anorexia, paresthesia, psychological and systemic symptoms. (17)
Homoeopathic philosophy raises interesting questions, eg "Tinctures possess a number of undesired side effects. Why would only the beneficial effects be amplified ("potentiated"), while all other side-effects would be attenuated?". (18) This logically leads us to the possibility that all high potency effects might be adverse effects. Ivons has warned: "Homoeopaths eagerly anticipate homoeopathic aggravations which are not always benign. Severe, even life threatening physical or emotional symptomology is possible in the guise of aggravation. We do a disservice to the public to tout homoeopathy as absolutely safe". (19) Dantas and Fisher, in a recent review of UK proving trials expressed surprise at finding that "most provings were done because of known properties of medicinal plants" and concluded :"on the negative side, some recent homoeopathic pathogenetic trials are unreliable and may be positively damaging to patients". (20)
Dr Fredric Motz, Chairman of the Homoeopathic Association of SA, in a 17 September 1997 submission to Parliament, clearly stated: "the public is unable to practice homoeopathy, and this goes for health shops and other health professionals. It is dangerous to practice homoeopathy without requisite knowledge and much harm can be done in this way. Arnica can cause fatal haemorrhage in certain individuals that take blood thinning agents (like Warfarin). Silica can open up old TB glands with deleterious effects. Phosphorus given to a bronchial carcinoma can easily lead to death. Caulophyllum may produce abortion at any stage of pregnancy etc. Much harm comes also from unqualified people treating or giving advice to sick people because due to lack of knowledge and diagnostic skill, this could lead to very dangerous consequences. It is wrong to assume a public right to self-medicate or buy via OTC, medicine used in homoeopathic practice".
Jonas: "Assessment of safety in homoeopathy is even worse. Even minimal approaches are usually not found. When done objectively, it has not indicated an innocuous nature, even with high dilutions. The author has seen a sudden severe aggravation of asthma necessitating hospitalisation. Homoeopathic literature teaches suppression or symptom shifting in which superficial treatment or symptom control results in deeper and more serious symptoms arising. Classical literature describes serious suppression arising from treatment in the hands of incompetent practitioners. Homoeopaths often see the return of old symptoms as a good sign rather than an adverse effect. Important issues arise about the interpretation of return of old pathological conditions, eg whether old pathologies might also return in serious conditions eg cancer, asthma or other diseases". (2) Benmeir et al report how "a patient with a melanoma, subsequent to exclusive postoperative treatment with homoeopathic remedies, developed a recurrent tumour weighing 1.8 kg." (21)
German researchers report: "Severe adverse reactions observed in association with homoeopathic remedies, including need for treatment in an intensive care unit. Hentschel et al recently analysed emergency room /intensive care unit admissions to the Medical Dept at the University of Erlangen to detect causal relationships between homoeopathic treatment and emergency hospitalisation. Homoeopathic treatment had been applied for an average of 18.6 days prior to admission. (In a 1-year period) 63 patients themselves attributed their complaints to the homoeopathic treatment they had received. With one exception, all were ‘above’ X 23." The shocking conclusion: "The rate of adverse reactions, 39.7 %, is (relatively) high." (22)
The public naively associate homoeopathy with wholesome herbs, but in addition to the above-mentioned serious safety considerations, common remedies often include highly objectionable, toxic and even disease-sourced causative organisms including cockroach, bedbug, snake, spider and insect and animal venoms, dog’s milk, rabid dog’s saliva, cancerous tissue, diphtheria virus, syphilitic virus, tubercular abscess pus with bacilli, and hundreds of other agents, including their inevitable combination with their vehicular milk-sugar tablets and alcohol drops, creating ethical problems for unsuspecting Jews, Muslims, Sikhs, Hindus and strict vegetarians and vegans. These products should accordingly carry mandatory explicit ingredient and warning labels, and in accordance with the lack of evidence of efficacy, bear no indications / false therapeutic claims
References
Stuart Thomson, Dir, Gaia Research Institute; National Co-ordinator, PHARMAPACT, May/Rev. June 1999.
P.H.A.R.M.A.P.A.C.T
Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny.
Ph/fax: 044-5327765; PO Box 2404, Knysna, 6570. E-mail: pharmapact@hotmail.com or gaia.research@pixie.co.za
Naomi Kulakow,
Center for Food Safety and Applied Nutrition (HFS-165), nkulakow@bangate.fda.gov
Food and Drug Administration.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
USA
20 May, 1999
Dear Naomi
HOMOEOPATHY / Dietary Supplements; CFSANS Public Meeting; FDA, HHS; Notice
[Federal Register: May 13, 1999 (Vol 64, No 92)][Notices][Page 25889-90][FDA][Docket No. 99N-1174]
With reference to the above
matter, would you kindly consider as our comments the attached
document titled "Safety Profile of Homoeopathy
Refuted". Very little objective research has been
conducted into adverse reactions arising from the use of
homoeopathic drugs, yet on recent occasion, when these have been
the focus of data collection and analysis, a surprising picture
of considerable risk, and an appalling risk-benefit ratio has
emerged and I would therefore appreciate your taking into account
the information provided, so that the FDA regulatory
double-standard, and clear bias against and prejudice of herbals
and nutritionals might cease.
Would you kindly acknowledge receipt hereof and if we are not
eligible to make this submission, timeously advise us of the
circumstances, so that one of our US members may do so on behalf
of our organisation. We have no intention to attend the meeting,
but require the submission to be entered as documentational
record.
Yours sincerely
Stuart Thomson
Director, Gaia Research Institute; National Co-ordinator, PHARMAPACT. South Africa
cc Chairperson, Director, Registrar, and Chief Medicines Control Officer:
South African Medicines and Medical Devices Regulatory Authority