3
homoeopathic remedies are very poisonous even in quite small allopathic doses the conventional toxicity test would tell us very little that is new. Also the effect of a substance in conventional allopathic doses is different from its effects in homceopathic potency. Indeed, the studies that have been carried out on the pharmacology and toxicology of a number of medicinal substances could well be the basis for' the development of new homceopathic remedies, but that is outside the scope of this discussion. As regards the future of homoeopathic remedies, it will be necessary to gather together as much evidence as possible of the effectiveness of the remedies and present it in a way that will stand up to scientific scrutiny. A search of the literature on the subject both from at home and abroad would in my view not be unrewarding. The next stage would be to devise some biological tests that could demonstrate an effect in vitro on cell cultures and unicellular organisms such as bacteria and protozoa. To this end the expertise of the cell biologist and molecular pharmacolo- gist would be of value, along with any other disciplines that may be relevant. Once such a corpus of knowledge has been assembled it can be used to back up clinical observations in both man and animals. It would then be possible to put forward positive suggestions to the DHSS and the Committee for the Safety of Medicines of ways in which homoeopathic remedies should be tested and be in a position to explain why the methods and protocols that are suitable for conventional medicinal substances will yield no useful results with homoeopathic remedies. Needless to say, such submissions would have to be supported by sound scientific evidence at every stage. To finish it is fitting to recall what Paracelsus, who is said to have had an influence on both hom~eopathy and modern toxicology, had to say in the sixteenth century. It was that there is no such thing as a non-poison, and it is the dose that makes the difference between a poison and a remedy. *The product licence number appears on the package of medicines offered for sale. The Medicines Act is administered by the Medicines Commission and the Department of Health and Social Security, The Animals (Scientific Procedures) Act is administered by the Secretary of State for the Home Department. Report from the working party on testing and licensing of medicines Our discussions were centred around the testing of the homoeopathic remedies, and the 1990 situation which is approaching fairly rapidly. The recommendations of the group were that we should invite the DHSS and the Committee for the Review of Medicines to consult the Faculty of Homeeopathy and the Research Council for Complementary Medicine in respect of suitable tests to be carried out in the review Volume 75, Number 4, October 1986 193

Report from the working party on testing and licensing of medicines

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homoeopathic remedies are very poisonous even in quite small allopathic doses the conventional toxicity test would tell us very little that is new. Also the effect of a substance in conventional allopathic doses is different from its effects in homceopathic potency. Indeed, the studies that have been carried out on the pharmacology and toxicology of a number of medicinal substances could well be the basis for' the development of new homceopathic remedies, but that is outside the scope of this discussion.

As regards the future of homoeopathic remedies, it will be necessary to gather together as much evidence as possible of the effectiveness of the remedies and present it in a way that will stand up to scientific scrutiny. A search of the literature on the subject both from at home and abroad would in my view not be unrewarding. The next stage would be to devise some biological tests that could demonstrate an effect in vitro on cell cultures and unicellular organisms such as bacteria and protozoa. To this end the expertise of the cell biologist and molecular pharmacolo- gist would be of value, along with any other disciplines that may be relevant. Once such a corpus of knowledge has been assembled it can be used to back up clinical observations in both man and animals. It would then be possible to put forward positive suggestions to the DHSS and the Committee for the Safety of Medicines of ways in which homoeopathic remedies should be tested and be in a position to explain why the methods and protocols that are suitable for conventional medicinal substances will yield no useful results with homoeopathic remedies. Needless to say, such submissions would have to be supported by sound scientific evidence at every stage. To finish it is fitting to recall what Paracelsus, who is said to have had an influence on both hom~eopathy and modern toxicology, had to say in the sixteenth century. It was that there is no such thing as a non-poison, and it is the dose that makes the difference between a poison and a remedy.

*The product licence number appears on the package of medicines offered for sale. The Medicines Act is administered by the Medicines Commission and the Department of Health and Social Security, The Animals (Scientific Procedures) Act is administered by the Secretary of State for the Home Department.

Report from the working party on testing and licensing of medicines

Our discussions were centred around the testing of the homoeopathic remedies, and the 1990 situation which is approaching fairly rapidly. The recommendations of the group were that we should invite the DHSS and the Committee for the Review of Medicines to consult the Faculty of Homeeopathy and the Research Council for Complementary Medicine in respect of suitable tests to be carried out in the review

Volume 75, Number 4, October 1986 193

of the licences for homceopathic remedies. We thought to be able to do this, three things were really needed. Firstly, we need a definition of 'a homoeopathic remedy' Which is acceptable both to the establishment and to homceopathy itself. Secondly, we thought it would be a good idea to know what was a valid test for homeeopathy in general, and whether one could be devised. Thirdly, we wanted to know about the testing of individual remedies: whether all the individual remedies should be tested and in all the potencies, which would of course be a tremendous task, or whether 20 or so remedies could be taken out at certain potencies and be tested, and whether this would be acceptable.

We felt that one ought to be able to go to any chemist's shop and buy a homoeopathic remedy and know it was exactly the same as the homGeopathic remedy in the chemist's shop down the road, so there had to be some standardiza- tion. We also considered that perhaps in non-homeeopathic minds there was a confusion at times between isopathy and homceopathy, and we ought to make that quite clear. Overall the community should attempt to seek the mode of action of homeeopathic remedies, which of course is all very simple!

BARRY R O S E

Discussion

DAVID REILLY: YOU say you are going to write to the DHSS, and the Committee for the Safety of Medicines--who is going to write?

BARRY R O S E : The Faculty.

DAVID REILLY: The Research Council for Complementary Medicine lags behind the British Hom0~opathy Research Group and the Blackie Foundation in develop- ing an awareness of the issues at stake. Can I propose that these bodies are involved?

BARRY ROSE: That is an excellent idea.

ALAN WARREN: The Bi~itish Hom~eopathy Research Group is closely connected with the Faculty. I suggest that you do not make any of these recommendations too unwieldly.

JULIAN KENYON: What about the education of the non-homeopathic groups involved?

BARRY ROSE" We had a homeopathic pharmacist in our group and he told us that he had to wait a considerable time before being granted a special manufacturing licence in 1980. He was turned down at first and subsequently he engaged a QC who had to distinguish, to the people who were offering this licence, what constituted a medicine, a hom~eopathic remedy and a herbal remedy. However, I think since then other people have obtained this special manufacturing licence.

DAVID REIELY: Taking up Julian's point about education, I throw up my hands in horror at the idea that every remedy and every potency has to be tested. What must be emphasized in very simple and short sentences is that there are claimed

194 The British Homoeopathic Journal

principles by which any toxic substance can be used homeeopathically, and these principles need to be examined. I understand that when testing a new vaccine, because the principle of vaccination has been established, it is dealt with in a different way compared with a new drug appearing on the market. It is the principles which need to be addressed.

PETER FISUER: Did you take into consideration how the DHSS might be persuaded (to put it politely) to include representation from hom~eopathy on its Reviewing Committee?

BARRY ROSE: We agreed on the need to put pressure on them, but at that stage we did not have enough time to take it any further, just the general principle.

DAVID REILLY: So it is perhaps appropriate that talks are set up between the bodies whom you are about to recommend that the DHSS consult with, in order that a concerted message can be evolved before approaching the DHSS.

MALCOLM CUILO: Could that last point perhaps be carried by the members of the Faculty today, and forwarded to the next Council Meeting?

DAVID REILLV: Proposed and seconded.

DAVID LEWIS: Taking up this point again about demonstrating the efficacy of homceopathic medication. Surely the whole argument about the homceopathic remedies is that 'preparations containing no molecules cannot work'. Surely all we have got to do is to demonstrate in principle that it does work. You only need to do it once, in an absolutely cast iron clinical trial which has a clear advantage in favour of the active treatment, and one could then earn a stay of execution as regards the 1990 deadline. Secondly, perhaps if one is going to do that, one should do two things: one should do the test at the threshold between material and non-material dose, and at an extremely high potency, because I think this jump from con- ventional medicine to hom~eopathy is too great for the scientist. I think we ought to make it easier for them.

DAVtt) REILLV: This point emphasizes that the separation between the political and the research element is artificial, and was really created for the purpose of this discussion today.

Volume 75, Number 4, October 1986 195