THE LANCET, OCTOBER
25, 1975
of c1ioquinol became known in 1965 or earlier but that this knowledge was not acted upon by the defendants who did not restrict or modify the availability of c1ioquinol. The judges will have to determine at what point in time, if any, failure to do this should be considered to have been negligent. Any individual who developed 8.M.O.N. before this date (only 677 cases are known to have developed before 1964) would then presumably not be entitled to damages. The legal issue in this case seems to differ in an important way from that in the actions which followed the thalidomide disaster. The case of c1ioquinol is the first to involve the relationship between safety and efficacy. A strong argument advanced on behalf of the plaintiffs is that when new information about suspected harmful effects becomes available it is encumbent upon both the manufacturers and government drug regulatory agencies to re-evaluate the evidence for the drug's efficacy. If the evidence for its efficacy is weak then even a suspicion of harmful effects from the drug should lead to some restrictions of its use.
United States TREES AND MEN
Last weekend, as the tail rains of a hurricane passed over Vermont, we joined the leaf-peepers and saw perhaps the greatest glory of the fall foliage in its highest colours. We drove through what seemed endless woodland; some trees were still in their summer green, but others were in full array, their colours ranging from warm brown through all the yellows of gold and orange to the flaming flamboyance of crimson and scarlet. Like all visitors, we marvelled at the enormous extent of the woodlands, but, coincidentally, this week the organisation called World Watch, which keeps an eye up and down the world for coming problems, drew attention to the devastating rate of destruction of wood throughout the world as the fuel shortage mounts. It instanced one African city in which there are now no trees within 40 miles of the city, and in country after country in the underdeveloped world trees are disappearing at a simply shocking rate in order just to provide fuel for cooking-quite apart from anything used for warmth. Estimates vary, but it seems that in some tropical countries each person uses between 1· 5 and I· 8 tons of wood each year, and even this moderate amount is deforesting their countries and is not being replaced by planting. Where trees are planted in tropical countries they have to be tended, watered, and protected from animals, especially the goats, which makes reafforestation, even if the intention is there, a difficult and expensive matter. As trees get more and more scarce the procurement of wood becomes ever more laborious-the woodcutters are further away, and transport costs mount. In some areas people have resorted to using dried animal dung as fuel-an old custom in the desert, where the camel obliged. With loss of trees the desert areas will increase, and every scrap of manure will be needed for fertiliser, already very scarce and very expensive, especially in the countries that need it most. None of this will particularly surprise those who have been travelling in the tropics in recent years. In every directionvin South-East Asia, in Africa, in South America, and in the Caribbeaa-strees seem to be disappearing even to the casual visitor's eyes, and the effects of erosion have become more and more evident. What is to be done? With the news of the OPEC decision to raise prices came much talk of their aid to underdeveloped countries; perhaps a large part of it had better go into reafforestation. Meanwhile, here in the U.S. forestry has been the subject of a very active research programme and work has been carried out on new strains of quick-growing timber, on selection of trees for special features, on new ways of getting seedlings off to a good start, and on cutting losses in growth, propagation, disease resistance, and so on. The results of all this research are being applied here as quickly as possible; but what is being done in West Africa, in Pakistan, in India?
811
Letters to the Editor WHOOPING-COUGH IMMUNISAnON POLICY SIR,-You report (Sept. 20, p. 544) that the statement from the Joint Committee on Vaccination and Immunisation has been prompted by concern over an apparent falling-off in acceptance-rates for the triple vaccine. This falling-off is probably due to the opinions of those who, like myself, are not convinced that the risks of pertussis are less than that of immunisation. There is a considerable body of opinion supporting this latter view and maintaining that immunisation against pertussis should be restricted to those infants at particular risk. I suspect that the real matter concerning the authorities is the fall-off in the other immunisations-diphtheria and tetanus. Since these are obviously essential, why not separate pertussis from the triple vaccine and make its use optional for those who, like myself, would never permit their own children to receive pertussis immunisation, but who welcome the other immunisations? There are, of course, a number of published studies which imply that the views of the Joint Committee on Vaccination and Immunisation are not entirely justified, and we await with interest the "unpublished reports" on which they base their current views. Dudlev Road Hospital, Birmingham B18 7QH.
P. M.
JEAVONS
WHOOPING-COUGH VACCINATION SIR,-There has been a continuing debate in your columns concerning the efficacy and dangers of whoopingcough vaccination. l - ' . However, few new data have been presented. We would like to report the vaccination status of 119 patients with a history, signs, and symptoms compatible with a diagnosis of pertussis. In 39 patients the diagnosis was also bacteriologically confirmed. The patients were admitted to hospital during the years 1972-75. The material is presented in three groups according to the vaccination schedule used in Finland. Pertussis vaccination is given in our country as pertussis/diphtheria/tetanus vaccine at the age of 3, 4, and 5 months. The booster vaccination is given at the age of 2 years. The immunisation status for age in the children at the time of infection is shown in the accompanying table. 66% (59/90) of the patients over 3 months of age had incomplete immunisation for age against whooping-cough, 41 % had no immunisation. Complete immunisation for age was thus recorded in 34% of the patients, and 26 of them (41 % of the group) had received the primary schedule with three vaccinations. During the years 1972-74 in Finland 95-99% of the infants received complete primary immunisation against whooping-cough. These observations are in agreement with previous studies which showed that about 75% of pertussis patients have received incomplete or no immunisation.",12 The efficacy of whooping-cough vaccination is in our opinion definitely proven, although the vaccine does not provide complete protection. There are no reliable data concerning I. Miller, C. L., Pollock, T. M., Clewer, A. D. E. Lancet, 1974, ii, 510. Gosding,}. V. T., Payne, D. J. H. ibid. p. 773. Miller, C. L., Pollock, T. M., Clewer, A. D. E. ibid. p. 773. Aicardi, J., Chevrie, J. J. ibid. p. 894. Preston, N. W. ibid. p. 1138. Gostling, J. V. T., Payne, D. J. H. ibid. 1975, i, 569. Dolby, J. M. ibid. p, 804. Fox, R. ibid. p. 916.
2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.
Preston, N. W., Stanbridge, T. N. ibid. p. 1089. Csizer, Z. ibid. p. 1089. Preston, N. W., Stanbridge, T. N. Br. med. J. 1972, iii, 448. lslur, J., Anglin, C. S., Middleton, P. J. Glin. Pediat. 1975,14,171.
812
THE LANCET, OCTOBER
IMMUNISATION STATUS OF us CHILDREN AT THE TIME OF PERTUSSIS INFECTION Culture Total
Status Positive Patients aged over 5 ma.: Complete immunisation .. Incomplete immunisation ., No immunisation .. Patients aged 3-5 mo.: Complete immunisation .. Imcomplete immunisation No immunisation .. .. Patients aged under 3 mo.: No immunisation ..
..
..
Negative
-------
7 6 5
19 5 21
26 11 26
2
..
3 7 0
4
5 11
11
11
..
11
18
29
39
80
119
.,
.. .. .,
the serious adverse effects of the pertussis vaccine, but the present advantages of the vaccine well outweigh the disadvantages. Department of Psediatrics, University of Turku, SF-20520 Turku 52, Finland.
TOIvo T. SALMI OLLI RUUSKANEN
Aurora Hospital and Department of Psediatrics, University of Helsinki.
RUTTA HUOVILA
Tampere Communal Hospital, Department of Psediatrics, Tampere Central Hospital.
ARJA OUTINEN RAIMO ANTTILA
Department of Infectious Diseases, University of Turku.
PENTTI HANNINEN
Department of Peediatrics, University of Oulu.
KAUKO KOUVALAINEN
THE M.R.C.P. AND ENTRY TO WGHER SPECIALIST TRAINING IN PlEDIATRICS SIR,-The Colleges have been reviewing the common part-n examination for the M.R.C.P.(U.K.) diploma, which was introduced in October, 1972. On the whole we are pleased with the examination and are satisfied that it is performing its function as an entry examination to higher specialist training. There is one point which is receiving special attention. The Joint Committee on Higher Medical Training recommends that those intending to specialise in medicine should enter higher specialist training four years after graduation and should usually achieve their membership during general professional training. Our experience suggests that the entry of psediatricians into higher specialist training is delayed because of the difficulties they encounter at present in the common part-rr written examination. Candidates may now opt to be examined in the orals and c1inicals in either general medicine or pediatrics. The written sections of the part-n examination require a fair degree of experience in adult medicine and analysis shows that candidates opting for peediatrics are at a disadvantage in the current written examination, particularly in the data interpretation and projected material sections (even though some pediatric questions are included). The Colleges have therefore agreed that a padiatric written section will be introduced as soon as possible in 1977. The standard of the examination will remain the same and some questions will be common to both the peediatric and generalmedicine options. Those candidates who have succeeded in the membership examination through the psediatric option should not in any way be considered to be "specialists" without undergoing higher specialist training as laid down by the Joint Committee on Higher Medical Training. Central M.R.C.I'. (U.K.) Office, c/o Royal College of Physicians, 11 51. Andrew's Place, l.ondon NWI 4LE
SCLEROSING PERITONITIS AND PRACTOLOL SIR,-You have published several reports of sclerosing peritonitis as a complication of praetolol therapy. We describe here a further case. A 50-year-old farmer's wife had a hysterectomy for myomas in 1971. She had postoperative pulmonary embolism but recovered well. From 1971 she had recurrent angina, and practolol (' Eraldin '), 1 tablet 2-3 times a day, was prescribed in September, 1972. This drug was given regularly until August, 1974. As supplementary therapy long-acting glyceryl trinitrate was prescribed, I tablet 2-3 times a day. From September, 1974, she had sporadic pain in the upper abdomen, vomiting, and meteorism. Her diet was found not to have any effect on these disorders. During the last days of March, 1975, heavy vomiting occurred. The patient was admitted to hospital, and a pleural" chafing" sound was discovered in the lungs. On palpation the abdomen was soft, but a large cystoid tumour, about 30 em in diameter, was palpable in the right umbilical region. X-ray revealed a partial intestinal obstruction. Contrast X-ray located it in the distal jejunum. On admission, the results of laboratory tests were normal. At laparatomy on April 8 a sheath 2-3 mm thick was found to be covering the organs in the abdominal cavity. The tumour proved to be a bundle of intestine covered by this sheath. The intestine was freed from adhesions and plicated. Postoperative recovery was normal. The specimen taken from the sheath corresponded fully with that described by Brown and his colleagues.' No oculocutaneous symptoms were found in our patient. Riihimiiki Regional Hospital, Riihimiiki, Finland.
S. SOIMAKALLIO K. VALLINMAKI H. LEHMUS.
1. Brown, P., Baddeley, H., Read, A. E., Davies, J. D., McGarry, J. Lancet, 1974, ii, 1477.
25,1975
JOHN CROFTON President, Royal College of Physicians of Edinburgh
FERGUSON ANDERSON President, Royal College of Physicians and Surgeons of Glasgow
CYRIl. A. CLARKE President, Royal College of Physicians of London
SURGICAL TRAINING SIR,-The letter from Professor B1andy and others (Oct. 4, p. 656) is important, for, as they point out, the British surgical Fellowships are now unique in being examinations taken at the beginning of training whereas those of the other Fellowships and the American Boards are at the end of higher surgical training. Higher surgical training in Britain has been revolutionised in the past few years with all the changes inherent in the now required inspection and approval of centres for higher training in each surgical specialty. In basic or pre-F.R.C.S. training I believe the British have shown great wisdom in retaining a prolonged training in surgery in general. In Edinburgh, for example, in a 3-year rotation in basic surgical training, the young surgeon may meet five specialties of surgery, giving him a width of education that is unsurpassed. In North America, in contrast, training outside the chosen final specialty has almost been eliminated. I hope we will never follow this pattern. It is tempting to do SO, for the surgeon in some of these countries graduates to full practice at the age of 31 or 32 whilst in this country on our old, disorganised pattern of training our surgeons were only obtaining consultant posts at the age of 37 or 38. Our new pattern of training, longer though it is than in some countries, is likely to shorten training very considerably and eventually men will be completing their surgical training at the age of 32 or 33-an average saving of 5 years over the present system.
25, 1975
of c1ioquinol became known in 1965 or earlier but that this knowledge was not acted upon by the defendants who did not restrict or modify the availability of c1ioquinol. The judges will have to determine at what point in time, if any, failure to do this should be considered to have been negligent. Any individual who developed 8.M.O.N. before this date (only 677 cases are known to have developed before 1964) would then presumably not be entitled to damages. The legal issue in this case seems to differ in an important way from that in the actions which followed the thalidomide disaster. The case of c1ioquinol is the first to involve the relationship between safety and efficacy. A strong argument advanced on behalf of the plaintiffs is that when new information about suspected harmful effects becomes available it is encumbent upon both the manufacturers and government drug regulatory agencies to re-evaluate the evidence for the drug's efficacy. If the evidence for its efficacy is weak then even a suspicion of harmful effects from the drug should lead to some restrictions of its use.
United States TREES AND MEN
Last weekend, as the tail rains of a hurricane passed over Vermont, we joined the leaf-peepers and saw perhaps the greatest glory of the fall foliage in its highest colours. We drove through what seemed endless woodland; some trees were still in their summer green, but others were in full array, their colours ranging from warm brown through all the yellows of gold and orange to the flaming flamboyance of crimson and scarlet. Like all visitors, we marvelled at the enormous extent of the woodlands, but, coincidentally, this week the organisation called World Watch, which keeps an eye up and down the world for coming problems, drew attention to the devastating rate of destruction of wood throughout the world as the fuel shortage mounts. It instanced one African city in which there are now no trees within 40 miles of the city, and in country after country in the underdeveloped world trees are disappearing at a simply shocking rate in order just to provide fuel for cooking-quite apart from anything used for warmth. Estimates vary, but it seems that in some tropical countries each person uses between 1· 5 and I· 8 tons of wood each year, and even this moderate amount is deforesting their countries and is not being replaced by planting. Where trees are planted in tropical countries they have to be tended, watered, and protected from animals, especially the goats, which makes reafforestation, even if the intention is there, a difficult and expensive matter. As trees get more and more scarce the procurement of wood becomes ever more laborious-the woodcutters are further away, and transport costs mount. In some areas people have resorted to using dried animal dung as fuel-an old custom in the desert, where the camel obliged. With loss of trees the desert areas will increase, and every scrap of manure will be needed for fertiliser, already very scarce and very expensive, especially in the countries that need it most. None of this will particularly surprise those who have been travelling in the tropics in recent years. In every directionvin South-East Asia, in Africa, in South America, and in the Caribbeaa-strees seem to be disappearing even to the casual visitor's eyes, and the effects of erosion have become more and more evident. What is to be done? With the news of the OPEC decision to raise prices came much talk of their aid to underdeveloped countries; perhaps a large part of it had better go into reafforestation. Meanwhile, here in the U.S. forestry has been the subject of a very active research programme and work has been carried out on new strains of quick-growing timber, on selection of trees for special features, on new ways of getting seedlings off to a good start, and on cutting losses in growth, propagation, disease resistance, and so on. The results of all this research are being applied here as quickly as possible; but what is being done in West Africa, in Pakistan, in India?
811
Letters to the Editor WHOOPING-COUGH IMMUNISAnON POLICY SIR,-You report (Sept. 20, p. 544) that the statement from the Joint Committee on Vaccination and Immunisation has been prompted by concern over an apparent falling-off in acceptance-rates for the triple vaccine. This falling-off is probably due to the opinions of those who, like myself, are not convinced that the risks of pertussis are less than that of immunisation. There is a considerable body of opinion supporting this latter view and maintaining that immunisation against pertussis should be restricted to those infants at particular risk. I suspect that the real matter concerning the authorities is the fall-off in the other immunisations-diphtheria and tetanus. Since these are obviously essential, why not separate pertussis from the triple vaccine and make its use optional for those who, like myself, would never permit their own children to receive pertussis immunisation, but who welcome the other immunisations? There are, of course, a number of published studies which imply that the views of the Joint Committee on Vaccination and Immunisation are not entirely justified, and we await with interest the "unpublished reports" on which they base their current views. Dudlev Road Hospital, Birmingham B18 7QH.
P. M.
JEAVONS
WHOOPING-COUGH VACCINATION SIR,-There has been a continuing debate in your columns concerning the efficacy and dangers of whoopingcough vaccination. l - ' . However, few new data have been presented. We would like to report the vaccination status of 119 patients with a history, signs, and symptoms compatible with a diagnosis of pertussis. In 39 patients the diagnosis was also bacteriologically confirmed. The patients were admitted to hospital during the years 1972-75. The material is presented in three groups according to the vaccination schedule used in Finland. Pertussis vaccination is given in our country as pertussis/diphtheria/tetanus vaccine at the age of 3, 4, and 5 months. The booster vaccination is given at the age of 2 years. The immunisation status for age in the children at the time of infection is shown in the accompanying table. 66% (59/90) of the patients over 3 months of age had incomplete immunisation for age against whooping-cough, 41 % had no immunisation. Complete immunisation for age was thus recorded in 34% of the patients, and 26 of them (41 % of the group) had received the primary schedule with three vaccinations. During the years 1972-74 in Finland 95-99% of the infants received complete primary immunisation against whooping-cough. These observations are in agreement with previous studies which showed that about 75% of pertussis patients have received incomplete or no immunisation.",12 The efficacy of whooping-cough vaccination is in our opinion definitely proven, although the vaccine does not provide complete protection. There are no reliable data concerning I. Miller, C. L., Pollock, T. M., Clewer, A. D. E. Lancet, 1974, ii, 510. Gosding,}. V. T., Payne, D. J. H. ibid. p. 773. Miller, C. L., Pollock, T. M., Clewer, A. D. E. ibid. p. 773. Aicardi, J., Chevrie, J. J. ibid. p. 894. Preston, N. W. ibid. p. 1138. Gostling, J. V. T., Payne, D. J. H. ibid. 1975, i, 569. Dolby, J. M. ibid. p, 804. Fox, R. ibid. p. 916.
2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.
Preston, N. W., Stanbridge, T. N. ibid. p. 1089. Csizer, Z. ibid. p. 1089. Preston, N. W., Stanbridge, T. N. Br. med. J. 1972, iii, 448. lslur, J., Anglin, C. S., Middleton, P. J. Glin. Pediat. 1975,14,171.
812
THE LANCET, OCTOBER
IMMUNISATION STATUS OF us CHILDREN AT THE TIME OF PERTUSSIS INFECTION Culture Total
Status Positive Patients aged over 5 ma.: Complete immunisation .. Incomplete immunisation ., No immunisation .. Patients aged 3-5 mo.: Complete immunisation .. Imcomplete immunisation No immunisation .. .. Patients aged under 3 mo.: No immunisation ..
..
..
Negative
-------
7 6 5
19 5 21
26 11 26
2
..
3 7 0
4
5 11
11
11
..
11
18
29
39
80
119
.,
.. .. .,
the serious adverse effects of the pertussis vaccine, but the present advantages of the vaccine well outweigh the disadvantages. Department of Psediatrics, University of Turku, SF-20520 Turku 52, Finland.
TOIvo T. SALMI OLLI RUUSKANEN
Aurora Hospital and Department of Psediatrics, University of Helsinki.
RUTTA HUOVILA
Tampere Communal Hospital, Department of Psediatrics, Tampere Central Hospital.
ARJA OUTINEN RAIMO ANTTILA
Department of Infectious Diseases, University of Turku.
PENTTI HANNINEN
Department of Peediatrics, University of Oulu.
KAUKO KOUVALAINEN
THE M.R.C.P. AND ENTRY TO WGHER SPECIALIST TRAINING IN PlEDIATRICS SIR,-The Colleges have been reviewing the common part-n examination for the M.R.C.P.(U.K.) diploma, which was introduced in October, 1972. On the whole we are pleased with the examination and are satisfied that it is performing its function as an entry examination to higher specialist training. There is one point which is receiving special attention. The Joint Committee on Higher Medical Training recommends that those intending to specialise in medicine should enter higher specialist training four years after graduation and should usually achieve their membership during general professional training. Our experience suggests that the entry of psediatricians into higher specialist training is delayed because of the difficulties they encounter at present in the common part-rr written examination. Candidates may now opt to be examined in the orals and c1inicals in either general medicine or pediatrics. The written sections of the part-n examination require a fair degree of experience in adult medicine and analysis shows that candidates opting for peediatrics are at a disadvantage in the current written examination, particularly in the data interpretation and projected material sections (even though some pediatric questions are included). The Colleges have therefore agreed that a padiatric written section will be introduced as soon as possible in 1977. The standard of the examination will remain the same and some questions will be common to both the peediatric and generalmedicine options. Those candidates who have succeeded in the membership examination through the psediatric option should not in any way be considered to be "specialists" without undergoing higher specialist training as laid down by the Joint Committee on Higher Medical Training. Central M.R.C.I'. (U.K.) Office, c/o Royal College of Physicians, 11 51. Andrew's Place, l.ondon NWI 4LE
SCLEROSING PERITONITIS AND PRACTOLOL SIR,-You have published several reports of sclerosing peritonitis as a complication of praetolol therapy. We describe here a further case. A 50-year-old farmer's wife had a hysterectomy for myomas in 1971. She had postoperative pulmonary embolism but recovered well. From 1971 she had recurrent angina, and practolol (' Eraldin '), 1 tablet 2-3 times a day, was prescribed in September, 1972. This drug was given regularly until August, 1974. As supplementary therapy long-acting glyceryl trinitrate was prescribed, I tablet 2-3 times a day. From September, 1974, she had sporadic pain in the upper abdomen, vomiting, and meteorism. Her diet was found not to have any effect on these disorders. During the last days of March, 1975, heavy vomiting occurred. The patient was admitted to hospital, and a pleural" chafing" sound was discovered in the lungs. On palpation the abdomen was soft, but a large cystoid tumour, about 30 em in diameter, was palpable in the right umbilical region. X-ray revealed a partial intestinal obstruction. Contrast X-ray located it in the distal jejunum. On admission, the results of laboratory tests were normal. At laparatomy on April 8 a sheath 2-3 mm thick was found to be covering the organs in the abdominal cavity. The tumour proved to be a bundle of intestine covered by this sheath. The intestine was freed from adhesions and plicated. Postoperative recovery was normal. The specimen taken from the sheath corresponded fully with that described by Brown and his colleagues.' No oculocutaneous symptoms were found in our patient. Riihimiiki Regional Hospital, Riihimiiki, Finland.
S. SOIMAKALLIO K. VALLINMAKI H. LEHMUS.
1. Brown, P., Baddeley, H., Read, A. E., Davies, J. D., McGarry, J. Lancet, 1974, ii, 1477.
25,1975
JOHN CROFTON President, Royal College of Physicians of Edinburgh
FERGUSON ANDERSON President, Royal College of Physicians and Surgeons of Glasgow
CYRIl. A. CLARKE President, Royal College of Physicians of London
SURGICAL TRAINING SIR,-The letter from Professor B1andy and others (Oct. 4, p. 656) is important, for, as they point out, the British surgical Fellowships are now unique in being examinations taken at the beginning of training whereas those of the other Fellowships and the American Boards are at the end of higher surgical training. Higher surgical training in Britain has been revolutionised in the past few years with all the changes inherent in the now required inspection and approval of centres for higher training in each surgical specialty. In basic or pre-F.R.C.S. training I believe the British have shown great wisdom in retaining a prolonged training in surgery in general. In Edinburgh, for example, in a 3-year rotation in basic surgical training, the young surgeon may meet five specialties of surgery, giving him a width of education that is unsurpassed. In North America, in contrast, training outside the chosen final specialty has almost been eliminated. I hope we will never follow this pattern. It is tempting to do SO, for the surgeon in some of these countries graduates to full practice at the age of 31 or 32 whilst in this country on our old, disorganised pattern of training our surgeons were only obtaining consultant posts at the age of 37 or 38. Our new pattern of training, longer though it is than in some countries, is likely to shorten training very considerably and eventually men will be completing their surgical training at the age of 32 or 33-an average saving of 5 years over the present system.
