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The proposed new "shuttle listings system", driven principally by the "big three" natural pharmaceutical companies dominating the Health Products Association, is a monopolistic GMP-based regulatory initiative, strategically favouring financial might rather than any proof of efficacy whatsoever.

The Dukes Review Report, essentially entrenching the listing system instituted by disgraced former MCC chaiman Folb, in line with a developing WHO pharmaceuticalisation / harmonisation policy, will seriously set back nutrition and herbalism via a self-favouring homoeopathy-driven compromise, whereby the least scientific modality benefits disproportionately by the Report's retrogressive policy position that "the criteria of demonstrated efficacy will be replaced by evidence that the medicine is used within a particular philosophy or tradition for particular purposes". This makes a telling mockery of the entire principle of medicines regulation.

Over-the-counter indication products, and especially the hard-sell combination formulae, do not meet the proposed new criteria. A further compromise is the clear position that "the criteria for reliable information will be modified so that claims can be accepted which do not transcend certain specified limits", and "no reference should be made to resistant conditions, major infectious diseases, asthma, cancer and epilepsy".

Whilst it is our position (based on the scientific studies to be presented) that these latter limitations are entirely appropriate for over-the-counter single and especially non-classical combination homoeopathic products, they are inappropriate, indeed devastatingly prejudicial to both nutritional and herbal products. Whereas considerable scientific validation exists for nutritional and herbal substances, and expands chrono-exponentially, the opposite pertains to homoeopathy, which is still struggling with hypothetical therapeutic rationale, and has yet to convincingly establish significant therapeutic efficacy for even a single remedy.

During the apartheid era, homeopathic remedies enjoyed a unique status in the health market-place, being largely unregulated until the mid-80's, and for the next decade illegally enjoying pseudo-registration status whereby product application numbers were allocated, but registrations never processed further, since no efficacy data existed, and yet these applications were never cancelled, in spite of constant MCC "need to prove efficacy" rhetoric, and these fraudulently remain on the market with unsubstantiated serious indication claims.

Subsequent to the democratic elections, the post-sanctions era heralded a flood of first-rate nutritional and herbal products onto the local market, in major competition with the local homoeopathic companies, who reluctant to relinquish their apartheid-gained monopolies, increased their familiarities with the now disgraced MCC hierarchy and via the HPA executive, despite financial vested interests, negotiated the terms of reference for the listing system to preferentially suit their local circumstances and pharmaceutical company status.

In South Africa today, only homoeopathy enjoys the benefits of taxpayer's money by means of grants to it's training faculties, in spite of it being the least scientific of all the complementary modalities. Two decades ago, the Board closed all courses teaching self-reliant homeopathy, naturopathy, and herbalism. A decade later two Technikons opened faculties teaching non-classical pseudo-homeopathy, with syllabi essentially teaching students biomedical homoeopathy, including dispensing of allopathic drugs to schedule 4, including antibiotics.

Recent graduates, no longer making their own remedies, now resort to purchasing commercial stock. Naturopathy and herbalism nearly became extinct, since with the exception of personal favours, issue of fraudulent certificates and occasionally admission of previously disadvantaged unqualified students for political expedience, not even internationally qualified graduates were granted registration by the new Interim Council, openly operating out of ideological bias in favour of homoeopathy, against naturopathy and herbalism.

Homeopathy dates back to the late 1700s when Samuel Hahnemann began formulating its basic principles, based on provings which have been in use for about 175 years without substantial revision. Its doctrine is not, and can never be, a theory of physiology or of the effects of drugs on the organism and pathological processes. Homoeopathy's elaborate symptomatic descriptions, require an extreme degree of individualised case-taking. The homoeopath has little leeway in the remedy selection and must at all times be guided by the symptoms (1).

Whatever is not compatible with Hahnemann's three rules is excluded from homoeopathy, which advocates the single remedy. The provings are never of mixtures. (1) Indication OTC's do not qualify as homoeopathy. The authors attribute the success of good homoeopathic doctors primarily to the healing power of the a compassionate and reassuring consultation (1-3 hours), plus the power of placebo (belief), which latter is estimated to contribute some 30% in randomised control trials of even orthodox medicines. One of us (ST) believes that the practitioner's confidence and desire to relieve suffering has a synergistic effect, according to the maxim--"energy follows thought". Both believe the homoeopathic remedy itself has no intrinsic effect.

The author's positions on the mere ritualistic value of homoeopathic remedies are borne out by the results of meta-analysis of randomised trials of homoeopathy, which actually show that placebo works better than the remedy. We believe that this homoeopathetic performance of the remedy results from the cold clinical style of non-classical and especially combination formula homoeopathy, and (ST) an explanatory commercial "greed factor" that actually diminishes the healer's / manufacturer's potential "energy follows thought" contribution.

A 1990 review of forty published European randomised trials covering a wide range of pathologies did not provide acceptable evidence that homoeopathic treatments are effective (2). A 1991 meta-analysis of 81 trials concluded that the evidence was not sufficient to draw definite conclusions, and indicated that publication bias (tendency to publish only positive studies) may have contributed to positive results (3). The most recent and comprehensive 1997 meta-analysis of 89 strict-criteria randomised placebo control trials by a German university Centre for Complementary Medicine Research concluded that there was insufficient evidence that homoeopathy is clearly efficacious for any single clinical condition (4).

Overall, placebo (nothing) beat homoeopathy in 6 out of 10 (58%) of the trials. Where homoeopathy narrowly beat placebo (allergy, neurology, rheumatology and miscellaneous), the ratio was 4 to 3, but where placebo beat homoeopathy, the ratios significantly favoured placebo: dermatology 6/3, gastroenterology 6/3, muscoskeletal 4/2, chest infection, asthma, ENT 11/4, and surgery and anaesthesia, 8/4, all in favour of placebo, with 100% superiority over homoeopathy (4). Some products sold as homeopathic medicines have herbal mother tinctures in their formulae, which are pharmacologically active and render them mildly effective.

The laws of chemistry state that there is a limit to the dilution that can be made without losing the original substance altogether, (Avogadro's number), which corresponds to homeopathic potencies of 12C or 24X. A 30X dilution means that the original substance has been diluted 1,000,000,000,000,000,000,000,000,000,000 times. To get even one molecule of the substance in common-place 30X pills, it would be necessary to take two billion of them, about a thousand tons of lactose tablets or one hundred plus tons of liquid drops.

If the mother tinctures are inconsistent, which locally they nearly always are, this must affect the potency millions of times. Even under the most scrupulously clean conditions, airborne dust in the manufacturing facility carry thousands of different molecules of terrestrial and even extraterrestrial origin. Similarly, the "inert" diluents used in the process have their own library of micro-contaminants. How is the emerging preparation supposed to know which of the countless substances in the container is intended to be potentised?