- Email: [email protected]
Pertussis, nosodes and product licences
The British Hom~eopathic Journal April 1987. Vol. 76. pp. 57-58
Editorial Subsequently all the nosodes have had the Licences of Right under which they have hitherto been manufactured withdrawn on grounds of quality control. This means that the right to manufacture these products no longer exists. However, stocks are considerable and the nosodes can still be dispensed for named, individual patients. It appears that pharmacies will continue to be permitted to carrry limited stocks for this purpose (although there is some doubt on this point). It is vital that we learn from this unfortunate episode. What lessons are to be drawn? Quality control: The old nosodes, of dubious provenance, must be replaced by new, authenticated material and these must be potentized by known, standard methods. Many of the nosodes presently available are of obscure origin, some originated in the United States many years ago. The exact nature of the starting material is, in most cases, not known nor, in many cases, is the method of potentization, though it seems likely that many of them were prepared by various 'continuous fluxion' methods. There is no generally agreed definition of the starting material nor standard method of sterilization for the nosodes. Clearly the manufacturers will require the help of the profession in obtaining fresh, authenticated material for the preparation of nosodes. Close liasion on this matter is a high priority. Unsupported claims: The Pertussin crisis was precipitated by the claim that this nosode is a safe and effective prophylactic for whooping cough--a claim unsupported by empirical evidence, or, for that matter, by the homoeopathic materia medica. Such claims are unethical and damaging. It should also be remembered that the validation of such claims may require the deployment of very large resources: in this issue we publish the results of a survey by Dr John English on the effect of Pertussin 30 in whooping cough prophylaxis. Without in any way detracting from Dr English's most important and timely effort, it is unfortunately true that the only firm conclusion that can be drawn from his study is that the resources available to him were not sufficient to allow any definite judgement on the efficacy or
Pertussis, nosodes and product licences This number of the British Homoeopathic Journal takes as its themes two important current issues in homceopathy--pertussis and proving methodology. The question of pertussis and, in particular, the use of the nosode Pertussin as a prophylactic for whooping cough is particularly pertinent for, in the past eighteen months, the hom0eopathic movement in Great Britain has suffered a major reverse centered around this issue. It is far from clear whence the idea that Pertussin might be effective in the prophylaxis of whooping cough emanated; certainly no such claim is made in any of the main homoeopathic materia medicas. Wherever it originated, the idea that Pertussin was a safe and effective preventive measure became widespread and demand was fanned by parents' concern at reports of the brain damage rarely caused by the conventional vaccine. The department of Health and Social Security became concerned that Pertussin was causing a significant dent in the uptake of the conventional vaccine, and took action. In December 1985, the Committee on the Review of Medicines gave notice to the homoeopathic manufacturers of their intention to revoke the product licence of Pertussin on the grounds of: 1 Quality Control--the source and content of the Pertussin then being used was unknown, even to the manufacturers. 2 Efficacy--'There is concern over the lack of efficacy of the product and this lack of effic:-:y poses a safety hazard to the individual and the community as the product is indicated for use for the prevention of whooping cough.' These objections placed the hom0eopathic manufacturers in an embarassing and virtually indefensible position; Nelson's agreed to cease manufacturing Pertussin. Weleda appealed, and were able to overcome the first objection by obtaining an authenticated sputum sample as starting material for the preparation of a new Pertussin. But they were unable to overcome the second objection and Pertussin has had its product licence withdrawn. 57
58 otherwise of Pertussin in whooping cough prophylaxis. Yet, to further complicate matters, it is still unclear what sort of evidence of efficacy will be required by the DHSS and its Committee on the Review of Medicines. There are indications that, initially at least, the level of proof will be less rigorous than that demanded for orthodox medicines. But there are no grounds for complacency. We have seen only too clearly how vulnerable we are. We cannot rely on the understanding or benignity of the authorities who may, themselves, be pressurized by vested interests alarmed at the growth of complementary medicine. Urgent action is needed to strengthen our position in anticipation of the general review of product licences which is to start in 1990. But if attack is the best form of defence we should consider, in parallel with the question of how to deal with the unwelcome attentions of the DHSS, how to develop and extend the art and the science of homeeopathy. It is in this context that we p u b l i s h three papers on proving methodology. One, from the veteran French homceopath Dr Denis Demar-
The British Hornoeopathic Journal
que, here published in English for the first time, shows the remarkable development of proving methodology since the time of Hahnemann, demonstrating that the homeeopathic movement has been in the forefront of innovation in clinical experimental methodology, including such now standard methods as the double-blind and crossover designs. The need for such methods is revealed in the late Dr Frank Bodman's classic study of Hahnemann's own provers, which we are reprinting in tribute to Dr Bodman. Until his death in 1980, Bodman was for many years one of the leading figures in British homeeopathy and introduced, through his many contributions to the British Homoeopathic Journal, a valuable element of critique and intellectual rigour. These two papers reveal a remarkable international convergence of views on the problems of proving. The time is now ripe for international agreement on outline protocols for proving-this is a question which the International Homeeopathic Medical League should address. The paper by Dr Koppers of West Germany which appears in this number is a contribution to the development of consensus on this question. PETER
FISHER
Copy dates Late copy for the July 1987 issue (correspondence, regional programmes, stop press news, etc.) MUST reach the Faculty Office by 4 June. Copy for the October 1987 issue should reach the editors by 9 July.
Editorial Subsequently all the nosodes have had the Licences of Right under which they have hitherto been manufactured withdrawn on grounds of quality control. This means that the right to manufacture these products no longer exists. However, stocks are considerable and the nosodes can still be dispensed for named, individual patients. It appears that pharmacies will continue to be permitted to carrry limited stocks for this purpose (although there is some doubt on this point). It is vital that we learn from this unfortunate episode. What lessons are to be drawn? Quality control: The old nosodes, of dubious provenance, must be replaced by new, authenticated material and these must be potentized by known, standard methods. Many of the nosodes presently available are of obscure origin, some originated in the United States many years ago. The exact nature of the starting material is, in most cases, not known nor, in many cases, is the method of potentization, though it seems likely that many of them were prepared by various 'continuous fluxion' methods. There is no generally agreed definition of the starting material nor standard method of sterilization for the nosodes. Clearly the manufacturers will require the help of the profession in obtaining fresh, authenticated material for the preparation of nosodes. Close liasion on this matter is a high priority. Unsupported claims: The Pertussin crisis was precipitated by the claim that this nosode is a safe and effective prophylactic for whooping cough--a claim unsupported by empirical evidence, or, for that matter, by the homoeopathic materia medica. Such claims are unethical and damaging. It should also be remembered that the validation of such claims may require the deployment of very large resources: in this issue we publish the results of a survey by Dr John English on the effect of Pertussin 30 in whooping cough prophylaxis. Without in any way detracting from Dr English's most important and timely effort, it is unfortunately true that the only firm conclusion that can be drawn from his study is that the resources available to him were not sufficient to allow any definite judgement on the efficacy or
Pertussis, nosodes and product licences This number of the British Homoeopathic Journal takes as its themes two important current issues in homceopathy--pertussis and proving methodology. The question of pertussis and, in particular, the use of the nosode Pertussin as a prophylactic for whooping cough is particularly pertinent for, in the past eighteen months, the hom0eopathic movement in Great Britain has suffered a major reverse centered around this issue. It is far from clear whence the idea that Pertussin might be effective in the prophylaxis of whooping cough emanated; certainly no such claim is made in any of the main homoeopathic materia medicas. Wherever it originated, the idea that Pertussin was a safe and effective preventive measure became widespread and demand was fanned by parents' concern at reports of the brain damage rarely caused by the conventional vaccine. The department of Health and Social Security became concerned that Pertussin was causing a significant dent in the uptake of the conventional vaccine, and took action. In December 1985, the Committee on the Review of Medicines gave notice to the homoeopathic manufacturers of their intention to revoke the product licence of Pertussin on the grounds of: 1 Quality Control--the source and content of the Pertussin then being used was unknown, even to the manufacturers. 2 Efficacy--'There is concern over the lack of efficacy of the product and this lack of effic:-:y poses a safety hazard to the individual and the community as the product is indicated for use for the prevention of whooping cough.' These objections placed the hom0eopathic manufacturers in an embarassing and virtually indefensible position; Nelson's agreed to cease manufacturing Pertussin. Weleda appealed, and were able to overcome the first objection by obtaining an authenticated sputum sample as starting material for the preparation of a new Pertussin. But they were unable to overcome the second objection and Pertussin has had its product licence withdrawn. 57
58 otherwise of Pertussin in whooping cough prophylaxis. Yet, to further complicate matters, it is still unclear what sort of evidence of efficacy will be required by the DHSS and its Committee on the Review of Medicines. There are indications that, initially at least, the level of proof will be less rigorous than that demanded for orthodox medicines. But there are no grounds for complacency. We have seen only too clearly how vulnerable we are. We cannot rely on the understanding or benignity of the authorities who may, themselves, be pressurized by vested interests alarmed at the growth of complementary medicine. Urgent action is needed to strengthen our position in anticipation of the general review of product licences which is to start in 1990. But if attack is the best form of defence we should consider, in parallel with the question of how to deal with the unwelcome attentions of the DHSS, how to develop and extend the art and the science of homeeopathy. It is in this context that we p u b l i s h three papers on proving methodology. One, from the veteran French homceopath Dr Denis Demar-
The British Hornoeopathic Journal
que, here published in English for the first time, shows the remarkable development of proving methodology since the time of Hahnemann, demonstrating that the homeeopathic movement has been in the forefront of innovation in clinical experimental methodology, including such now standard methods as the double-blind and crossover designs. The need for such methods is revealed in the late Dr Frank Bodman's classic study of Hahnemann's own provers, which we are reprinting in tribute to Dr Bodman. Until his death in 1980, Bodman was for many years one of the leading figures in British homeeopathy and introduced, through his many contributions to the British Homoeopathic Journal, a valuable element of critique and intellectual rigour. These two papers reveal a remarkable international convergence of views on the problems of proving. The time is now ripe for international agreement on outline protocols for proving-this is a question which the International Homeeopathic Medical League should address. The paper by Dr Koppers of West Germany which appears in this number is a contribution to the development of consensus on this question. PETER
FISHER
Copy dates Late copy for the July 1987 issue (correspondence, regional programmes, stop press news, etc.) MUST reach the Faculty Office by 4 June. Copy for the October 1987 issue should reach the editors by 9 July.