Dec 14, 1985 - G Mathe, MD, and Sophie Dion ..... ..... 1720. Osteopathic ..... 10 Howell A, George WD, Crowther D. Controlled trial of adjuvant chemotherapy ...
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VOLUME 291
14 DECEMBER 1985
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CORRESPONDE Landmarks in medicine P B S Fowler, FRCP ......... ........... Treatment of severe falciparum malaria A Bryceson, FRCP ..................... Occupationless health T M Lang, PHD; V Roberts, MB ..... ..... Proposal for ethical standards in therapeutic trials G Mathe, MD, and Sophie Dion ..... ..... Osteopathic manipulation resulting in damage to the spinal cord J Davidson, MRCGP; A H Laxton, MB; R S MacDonald, MRCP, MRO; D M Smith, MRCGP, MRO .......
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Safety of cimetidine R Seidelin, FRCP; D G Colin-Jones, FRCP, and others; J Tapson, MRCP, and H Mansy, MRCP; K H Cansdale, FRACS ...... ....... Growth hormone 1985 T Fry ............................... Misleading guidelines on oxygen treatment in asthma A T Elder, MB, and G K Crompton, FRCPED; F Wells, MB ........ .................. Fibrinogen: a possible link between social class and coronary heart disease E Ernst, MD, and others ................
Antisecretory drugs and gastric cancer F I Lee, FRCP ........................ Patients with suspected Lassa fever in 1719 London during 1984 RT D Emond, FRCP .1723 1719 Parenteral nutrition S H Anderson, MRCP, and T J Charles, M RCP ............................... 1720 Use of electronic mail for patient record transmission 1719
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MRCP
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PN Gaunt, MRCPATH .................. Staphylococcus saprophyticus as a urinary pathogen P R Hunter, MRCPATH, and C D Ribeiro,
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MB .................................
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Phaeochromocytoma presenting as an acute abdomen R J Buist, FFARCS ...................... 1722 Banned drugs BHJ Briggs,MB, and others .1725 1722 Should nuses practise prevention? Constance M Martin, SRN .1725 Screening for Down's syndrome 1723 I White, LIBIOL, and D E Magnay, MB
Carbon monoxide poisoning in childhood Sarah Janes, MRCP, and Bridget Lock,
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Crohn's disease in the elderly MA Walker, FRCS, and others .1725 Telling the truth and medical ethics J Spencer Jones, MB .1726 Polaroid non-mydriatic retinal photography D N S Gleadhill, MRCP .1726 Malpractice: a New Zealand solution to an American crisis J N P Davies, FRCPATH .1726 Social workers and the Mental Health Act 1983 I G Bronks, FRCPSYCH .1726 Paying for others' mistakes I R Fletcher, FFARCS .1727 Spirit of Griffiths hijacked PV Scott, FARCS .1727 Practice information booklets R M Milne, MRCGP .1727 Choked by words BM Goldman, PHD .1727 Si momentum requiris, circum spice A Sakula, FRCP ....................... 1727
Because we receive many more letters than we have room to publish we may shorten those that we do publish to allow readers as wide a selection as possible. In particular, when we receive several letters on the same topic we reserve the right to abridge individual letters. Our usual policy is to reserve our correspondence columns for letters commenting on issues discussed recently (within six weeks) in the BMJ. Letters critical of a paper may be sent to the authors of the paper so that their reply may appear in the same issue. We may also forward letters that we decide not to publish to the authors of the paper on which they comment. Letters should not exceed 400 words and should be typed double spaced and signed by all authors, who should include their main degree.
Landmarks in medicine SIR,-All will admire Sir Christopher Booth's eloquent praise of scientific medicine in the United States over the past 100 years (23 November, p 1444). Some might disagree both with his suggestion that comparable work has not emanated from Great Britain and with his reason for this supposed failure-namely, the rarity of "active invasion of the teaching hospitals by the universities." An ignorant reader might gain the impression from Sir Christopher's article that penicillin treatment was an American success story. While penicillin was the fruit of university departments, it is often forgotten that virtually all subsequent antibiotic drugs have been discovered and developed by the frequently maligned pharmaceutical industry. It is also sad that the invention that revolutionised medical investigations failed to keep its original name of emiscan, which would have been a lasting reminder to the world of British industrial inventive genius. When Donald Hunter produced his great classic treatise 40 years ago on industrial medicine the London Hospital staff included giants such as Lord Brain, William Evans, and Lord Evans. These men exerted a profound influence on medicine, and no one since has taken their place in this respect. However, brilliant innovative doctors from this country, such as Denis Burkitt, Sir Cyril Clarke, and Deborah Doniach, combine energy, enthusiasm, and genius. Inevitably this happy mixture of attributes is rare but this should no longer invoke the old excuse that we lack "an
active invasion of the teaching hospitals by the them design a controlled study that would sort out universities." This invasion has been successfully these differences ofopinion in a defined category of completed; it has not been an unmixed blessing. patients and that Dr Hall should go to Thailand and carry out such a study with Dr Warrell. In the mean time, I suggest that neither your P B S FOWLER Charing Cross Hospital, good self nor other journals, including abstracting London W6 8RF journals, provide any more space for this acrimony. You have already turned down one article of mine on leprosy in England on account of lack of Treatment of severe falciparum malaria space; I don't want it to happen again.
SIR,-Enough is enough. The quarrel between Dr A P Hall and Dr D A Warrell (26 October, p 1146; 30 November, p 1573) is getting us nowhere. Dr Warrell's team are treating Thai villagers with severe falciparum malaria in rural conditions. In these patients they are carrying out carefully conducted clinical and pharmacological trials so that the care of patients with this potentially lethal condition may be sensibly advanced on the basis of objective evidence. Dr Hall is treating a heterogenous collection, mainly Europeans, with African malaria of varying severity in the highly sophisticated circumstances of a London teaching hospital. The results of this series have not been published in any detail. There is, therefore, little basis on which one can justifiably say that one is right and the other is wrong with regard to such matters as the loading dose of quinine. I would like to suggest that the two protagonists, who are both distinguished workers with the highest ethical standards, should put down their swords and have a fireside chat. I would like to see
ANTHONY BRYCESON Hospital for Tropical Diseases, London NW1 OPE
Occupationless health SIR,-After Dr Richard Smith's excellent focus on the relation between unemployment and diet in your journal may I add further comments on some differences between the impact of unemployment on diet in the 1930s and the 1980s? There are both similarities and differences between then and now, but they are not quite what many would expect in the post-Beveridge era of supposed welfare safety nets. Firstly, the rise of direct debiting-sums to meet bills such as those for gas and rent being removed at source-means that welfare recipients now may actually have less money to spend on food than the official DHSS estimate of £10-25 per adult per week. By giving priority to non-food budget
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items direct debiting can take away the unenviable task of juggling between household items. Household food intake often suffers as a result. Secondly, the restructuring of the UK grocery market, or, more exactly, the collapse of the number of retailing grocery outlets, which halved between 1974 and 1983, has meant the removal of credit for food for the poor. "Tick" at the local shop is a thing of the past. Thirdly, the availability of nutritious good quality food is now in some respects more problematic than in the 1930s because the past 30 years have seen the rise of high value added foods, which tend to have low nutritional value. Fourthly, in the 1930s food, or its lack, was an issue of the greatest public concern, whereas today the welcome return of interest in food policy has been based on the mistaken assumption that many mass food problems are those of an affluent society. In truth, the problems of food scarcity are still here today for millions of people in Britain at the same time as those problems mistakenly attributed to affluence. Finally, food overproduction, or overproductive capacity, there may have been in both the imperial 1930s and the European Community 1980s, but the existence of food surpluses bears little relation to the social distribution of food. Then, as now, cash mediates between need and access to food. T M LANG Director
London Food Commission. London N 5 I DU
SIR,- I have great esteem for the BM] as a journal of medical science with a provision for affairs of medicopolitical value. I am disgusted and ashamed to observe Dr J Munro's personal views printed in your pages (16 November, p 1427). I trust that you will not degenerate into a (fascist) political magazine.
VAUGHAN ROBERTS Ainwick. Northumberland NE66 2PS
*** Our correspondence columns exist to allow comment and discussion about the papers we publish. The fact that we print a letter does not necessarily imply that we agree with the sentiments it expresses. We think unemployment is an important issue and would welcome constructive debate. -ED, BM7.
Proposal for ethical standards in therapeutic trials SIR,-Dr Ian Lennox-Smith (2 November, p 1279) and your other correspondents (16 November, p 1422) defend trials in normal healthy volunteers, which the ethical committee of the Service des Maladies Sanguines et Tumorales has condemned'` on the grounds that any subject submitted to a trial should have something to hope for from the studied treatment and nothing to risk. A normal healthy subject has by definition nothing to hope for and takes the risk of a toxic effect when nobody can affirm that a given drug is not toxic: aspirin4 and non-steroidal anti-inflammatory drugs5 are examples of drugs which one would initially accept for study in normal subjects and which long term use has shown to be possibly toxic. As for phase I studies,' for the same reasons the committee considered it unacceptable to apply doses which are not efficient, as is done in the interpatient escalation models. We have therefore used, even for cytostatic agents, the intrapatient
escalation model with the advantage of finding more beneficial results, as all patients finally received an efficient dose-and without incident.6 So far as informed consent is concerned, I have only to quote the case of the patient who died from a trial which was not necessary for her, to which she did not consent, and to which her husband was totally opposed. On randomisation the committee considered our demonstration that in disease free survival and in survival exponential curves there are usually three subgroups with different slopes and that the last is often parallel to the normal life expectancy, which means that the patients represented are cured.8" It is not ethical to submit half of them to the toxicity of a treatment which may induce late severe complications, as shown by Howell et al in a trial of cyclophosphamide, methotrexate, and fluorouracil" which showed no benefit on survival but severe bone marrow lesions." Thus instead of applying a treatment to all patients, as in conventional randomised controlled trials, we conduct two trials, generally applying two different treatments, one on patients on the first rapid slope segment, another on those on the second moderate slope segment, and none on the cured
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general practitioner would have referred any of these particular cases to an osteopath or even to a consultant in osteopathic medicine for they are all cases which are obviously unsuitable for manipulation. The first reported case should not have been manipulated. Pain, paresis, or Lhermitte's sign in all four limbs is a contraindication to manipulation. In the second case manipulation of the lumbar spine at the age of 70 is quite acceptable, but to treat a cervical spine at that age with any treatment other than gentle traction is not acceptable. With regard to the third case, any patient who looks ill or has lost weight should be investigated before treatment. If these patients had been treated by a consultant in osteopathic medicine, or a member of the Register of Osteopaths, these accidents would have been avoided. Furthermore, to my knowledge, there are no published reports of any accidents caused by a consultant in osteopathic medicine. Members of my association treat many doctors, including neurosurgeons and orthopaedic surgeons. I find it hard to believe that ifosteopathic manipulation has no beneficial results, or is actually harmful, such patients would come to the members of my association for treatment. patients. The fact that the ethical and medical problems of JOHN DAVIDSON Chairman clinical trials have not yet been solved should encourage the study of new models6 12 and reflec- Osteopathic Medical Association, tions broader than those of pharmacological London Wl considerations. The best solution is that all citizens know the methods: for this reason, we are creating SIR,-Mr C Davis has quite rightly brought to our an international society of patients who refuse to be notice three cases in which osteopathic manipularandomised for any treatment. tion is assumed to have resulted in acute spinal GEORGES MATHI: cord injury requiring surgery. It is good to know SOPHIE DION that in two of these cases appropriate skilled Institut de Cancerologie et surgical intervention was effective in minimising d'lmmunogene'tique, subsequent morbidity, and that only in the third Group Hospitalier Paul-Brousse, case, where there was underlying carcinomatosis, 94800 Villejuif, France was the progress poor. 1 Durrv G, Dion S. Considerations sur l'&hique des etudes phase In case 1 the symptoms of spinal cord injury I. Blomed Pharmacother 1984;38:423-4. 2 Dion S. Considerations sur l'ethique des etudes phase II. were present before the manipulation. In this and Blamed Pharmacot/her 1984;38:425. in the two other cases the decision to manipulate 3 Arpaillange P, Dion S. Considerations sur l'ethique de la may have been ill advised, but it is not possible to randomisation. Biomed Pharmacother 1984;38:426-9. 4 Assouline SR. Prudence avec l'aspirine. Pratique AfMdicale conclude, simply on the basis of the observed sequelae, that there was a clear and absolute Quotidzenne 1985;156:6. 5 Mattison N. Unexpected side effects: the regulatorv implica- contraindication to manipulate in these cases. tions of the Oraflex and Zomax withdrawals in the USA. Most of us would agree that the very real dangers Pharnaceut Med 1984;1:13-6. 6 Mathe G, Triana K. Intrapatient escalation in phase I trial of L- in using non-steroidal anti-inflammatory drugs OHP. Cltn Pharmacol Res (in press). does not mean that they should never be pre7 Brahams D. Death of patient participating in trial of oral scribed. Neither does the occurrence of morbidity morphine for relief of postoperative pain. Lancet 1984;i: and even death after anaesthesia and surgery 1083-4. 8 Eriguchi, Mathe G. Analysis of survival and DFS curves: for preclude their expert use for the relief of pain and understanding the effect of adjuvant therapy of malignant the treatment of disease. The three cases reported disease. Oncologia 1985;12: 146-8. need to be seen in relation to the many thousands of 9 Mathe G, Gouveia J, Eriguchi M, Reizenstein P. Passive, adoptive and active immunotherapy: a review of clinical trials effective manipulative treatments given. In the in cancer. Med Oncol Tumor Pharmacother (in press). region served and over 12 months a reasonable 10 Howell A, George WD, Crowther D. Controlled trial of estimate would give an incidence of 3 per 1 000 000 methoadjuvant chemotherapy with cyclophosphamide, trexate and fluorouracil for breast cancer. Lancet 1984;ii: treatments. It is clearly important that manipulation should 307-11. 11 Howart JMT, Howell A, Testa NG. Paterson laboratorv and be carried out by people who are trained medical oncologv annual report. Manchester: Trafford, 1983: and skilled. It is also highly desirable that all 101. 12 Mathe G, Eriguchi M. A new model for comparative trials based such treatment should be in the context of good on the multisegment slope of disease-free survival and interprofessional understanding and respect, thus survival curve. Blomed Pharmacother (in press). facilitating consultation with other specialists at any stage in the care of a patient. No one individual, be he GP, osteopath, or surgeon, can claim supreme competence and authority. We are indiOsteopathic manipulation resulting in viduals in a team. damage to the spinal cord Those of us who work in manual medicine often SIR,- Dr C Davis writes about the British Society see patients who have for months or years been of Osteopathy (30 November, p 1540). As there is subjected to the full battery of invasive investino such society one does not know what kind of gations, yet have not received effective treatment. osteopath manipulated his second patient, and, In many of these cases-though not all-careful indeed, all three patients may have been treated by examination and the subsequent application of unregistered and untrained osteopaths. appropriate, precise, gentle manipulation will give Furthermore, he states that the medicolegal almost immediate relief and set the patient on the implications of doctor to osteopath referrals are self path to full recovery. evident. I find it impossible to believe that any Our rheumatologist colleagues constantly decry
