WHO report on the safety issues in the preparation of homeopathic medicines

In February 2010, the World Health Organization (WHO) published a report on the ‘Safety issues in the preparation of homeopathic medicines’. Since then I have received many messages about parts of it being against homeopathic fundamentals. I decided to give it a thorough reading and explore the philosophical and scientific problems in the document.

The first thing I realized, was that this is an excellent step towards standardization of homeopathic remedies globally. The document underlines the differences in different homeopathic pharmacopeias and the need for standardization so that the potencies prepared in different countries do not vary much. I feel that international homeopathic bodies should come together to create a new and updated pharmacopoeia, which gets accepted by all participating countries gradually.

Another good thing is that this document is very thorough and covers different aspects of quality control of homeopathic medicines in detail. It gives a good structure that homeopathic pharmaceutical companies should follow for better quality control.

One criticism that I had come across was that this report has been prepared by non-homeopaths. Contrary to this belief, I found that the report has been examined by many leading homeopathic bodies and their advice and suggestions have been incorporated in this report. The full list of people instrumental in creating this report can be seen in Annexure 1 of this report.

Now let us come to the problem areas. If you read the report alone, there is very little negative to point to. It is the annexure, where the little details that matter are hidden.

The first thing that struck me was the way homeopathic remedies were defined. Section 2.1 gives an introduction about homeopathic medicines as:

Homeopathic medicines are based on the principle that high dilutions of potentially active molecules retain a memory of the original substance.

This is not true! Homeopathic medicines are based on the principle of symptom-similarity. They ‘memory’ concept is just one of the many hypotheses put forward to explain the action of homeopathic remedies. It should not be described as a definite principle.

Apart from this, there are three potential areas of concern:

1. Comments about the safety of Nosodes, Sarcodes and Remedies derived from toxic substances.
2. First safe preparation.
3. Recommended source of animal remedies.

Potential Safety Hazard

The bias about the potential harmfulness of homeopathic remedies sourced from biological materials is stated in the preface of the report itself. Dr. Xiaorui Zhang, Coordinator, Traditional medicines, W.H.O., writes in the preface:

Sometimes, a homeopathic medicine made from source material, such as a mother tincture, is administered in the most concentrated form. Secondly, homeopathic medicines are made from a wide range of natural or synthetic sources: minerals and chemicals, but also plant materials, including roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae; microorganisms, including fungi, bacteria, viruses and plant parasites; animal organs, tissues, secretions and cell lines. Human materials may include tissues, secretions, hormones, and cell lines. Some of these source materials constitute potential safety hazards, even at high dilutions.

I absolutely agree that some of these substances do constitute a safety hazard in material doses and very low attenuations, but where is the proof that they are a potential toxic hazard even at high dilutions? This is merely an assumption. There has never been a recorded case, where homeopathy remedies prepared according to the authorized pharmacopeias and practiced by qualified homeopaths have resulted in any serious injury to the patient or spread of any infection. If the W.H.O. is concerned about safety of high dilutions, they should test homeopathic remedies in high potencies for potential carriers of biological diseases, or conduct some long-term research trials for the same. Without a single known case of harmfulness of high dilutions and no research to deduce the same, the statement that homeopathic remedies can be hazardous in high dilutions, is frivolous at best!

First Safe Preparation

To minimize the possible safety hazards of homeopathic remedies, the report proposes to identify the first safe preparation of each homeopathic remedy and only the potencies above that first safe preparation should be available in the market.

This sounds like a decent idea but has many hidden implications to it. Mercury, Arsenic, Stramonium, Lachesis, Vipera etc are all toxic in crude form. The document does not specify how the first-safe preparation should be ascertained. Are the remedies deemed safe once there is not even a trace of the original substance detectable? If that be the case, we will lose most of our remedies in lower potencies (below 12C)!

One should remember that the toxicity not only depends upon the level of dilution but also upon the amount/volume of the substance consumed. So, while Lachesis or Arsenic-album 3C might have some traces of the original toxin, their toxicity actually depends upon the dose consumed.

One should also remember that most conventional drugs are ‘toxic’ in large doses. So it is not the toxicity of the original substance but the ‘dose’ that ultimately matters. Homeopathic remedies are usually given in very small quantities and as such do not have any potential toxic effect. Still, if control is required by health authorities, then two things can be done:

1. Low potencies of highly toxic substances can be made available only on prescription of a qualified and registered homeopath.
2. The packaging volume of such potencies can be restricted to a relatively safe level, say 10 ml to 30ml.

Section 3.2 deals with the animal or human derived source material. It states:

Adequate and validated procedures such as filtering, pasteurization, sterilization or precipitation have to be used depending on the individual raw material, contamination or pathogenic load, especially to establish the first safe preparation. The dilution process alone is not sufficient to establish microbial, viral or TSE safety.

This again looks reasonable but ignores the spirit of homeopathic provings. Will the Lac humanum, Lac def, Lac can be the same if prepared from pasteurized milk? Will your Bacillinum, Medorrhinum, Syphilinum, Tuberculinum etc. be the same if prepared after sterilizing the tissue or using deactivated microorganisms cultured in laboratories? (see section 4.1.5 and 5.3 of annexure 3)

I think instead of sterilizing and pasteurizing the source material, the right thing would be to test samples of the recommended first-safe preparations for any active pathogens.

Recommended source of animal remedies

Section 4.1.1 of Annexure 3 gives guidelines about the source of homeopathic remedies of animal origin. It states:

Healthy animals should be used for the production of homeopathic medicinal products unless properly justified. Whenever possible, donor animals should be held in closed breeding and production herds. Wild animals should be avoided as far as possible.

If all remedies prepared from animal source are derived from captive animals, the remedy picture of the medicine thus derived is unlikely to match the remedy picture that came up during the original proving. The diet, life-style, experiences and behavior of animals kept in captivity vary significantly from their wild counterparts. Most homeopaths believe that it is not merely the material substance, the quantifiable tissue that matters. The totality of the source also reflects in the remedy picture. If the totality of the source varies considerably from the one used in our initial provings, how can the remedy picture remain the same?

The same applies to the plant remedies too. The mineral content and the quantity and quality of the biologically active substances in a cultured plant may vary a lot from the one taken from the wild.

I think it is necessary that homeopathic bodies reflect further on these suggestions and work together to modify such recommendations coming from W.H.O.

In general there is a lot of good information in this report and every homeopath should go through it once. You can get a copy of this report here:

http://www.who.int/medicines/areas/traditional/Homeopathy.pdf

or

http://www.who.int/medicines/areas/traditional/prephomeopathic/en/index.html

It is a good initiative towards standardization and acceptance of homeopathic remedies. Some points do need further clarification, deliberation and modification, to conform to homeopathic principles and practices.

If you find the issues raised above a valid concern, please take out five minutes from your busy schedule and write to your national homeopathy organizations to take up these issues with W.H.O.

Do send us your comments and feedback at editor@hpathy.com

Manish Bhatia

Editor,

Homeopathy 4 Everyone