1052
pranolol treated patients, when osteodystrophic repair would be expected to be most active. Follow-up of these patients from four months onwards showed normal S.A.P. levels, irrespective of preoperative preparation.
thyrocalcitonin release may indeed play some part in explaining transient falls in serum-calcium after thyroid operations, we feel that proponents of this idea should back it by using highly sensitive immunoassays of calcitonin now available. We cannot agree, however, that hypocalczmia lasting longer than a day can be so explained, and we believe that the avidity of thyrotoxic osteodystrophic bone for calcium is then the best explanation. Furthermore the thyroids of pigs pretreated with methylthiouracil had an impaired ability to secrete calcitonin.5 This might help to explain why the fall in While
serum-calcium in the series of Wilkin et al. was of greater statistical significance in the patients with functionally normal non-toxic goitre. W. MICHIE Departments of Surgery, Medicine, and J. M. STOWERS Chemical Pathology, S. C. FRAZER of Aberdeen University
mean
investigation which is not for their benefit where the studies are sound, promise important new knowledge and there is no discernible risk", adding the necessity for informed parental consent.
Campbe1l6 states "the only real protection for the individual scrupulousness, conscience and personal integrity of the investigator." But individual conscience varies too, and who then decides what is negligible risk, discomfort, and "inlies in the
formed" consent? Ethical committees are admirable in concept but "they vary in their membership, their influence and in There is no consistent their interpretation of their role ...
policy."6 Perhaps any further guidelines have to wait until, as Sir Cyril Clarkes suggests, someone makes a test case with the backing of a medical defence body: but, should such support be wanting, what individual doctor, acting against legal and protessional advice, is going to risk his head on the chopping block and rely on an ethical committee’s decision to stop it tumbling off. "Tar-baby, she ain’t saying nothing-and Brer Fox, he still lay low!"’ Town Farm, West Street,
RESEARCH ON INFANTS
SIR,-I am grateful to Dr Gairdner for the references in his letter (April 16, p. 852) concerning blood-sampling in infants but I cannot agree with his suggestion that I "need not have left the matter there". I did not. The Medical Defence Union confirmed the advice of the paediatrician on the local ethical research committee (i.e., that blood-sampling for research in infants was not legally permissible), and cautioned me against proceeding with this. I then referred, at the suggestion of the British Medical Association, to Professor Oppe, professor of paediatrics, London University, who, informed of the circumstances, supported this view. Both knew that my research programme (to determine whether the type of early feeding is related to the incidence of asthma in children) involved following up babies at home in preference to hospital outpatients, and that this included regular bloodsampling for assessment of immunoglobulins and milk antibodies. As Dr Dodge and Dr Evans point out in their letter (April 16, p. 852) there are risks in blood-sampling, however slight, and, in view of the advice I had been given, it did not seem justifiable to me (a mother, a doctor, and a magistrate) to proceed with this, when, although immunoglobulin studies are relevant, they are not essential to what I am trying to establish. This was a "value judgement",’ as it happens by a woman. (I note that all the writings I have seen in support of blood-
sampling are by men!) research blood-sampling in general which letter. prompted my The views of authoritative bodies vary from the Department of Health view expressed by Sir George Godber2 that it is not legitimate to do experiments in children which are not in the interests of that particular child, to the Royal College of Physicians recommendation3 that "clinical research investigation of children ... which is not of direct benefit to the patient should be conducted, but only when the procedures entail negligible risk or discomfort and subject to the provisions of any common and statute law prevailing at the time. The parent or guardian should be consulted and his agreement recorded." The Medical Research Council statement4 questions the legal competence of parents to give such consent. The 1973 editorial in the Archives of Diseases in Childhood concurs with Curran and Beecher5 that "children under 14 may participate in clinical But it
Marlow, Bucks SL7
HELENOR PRATT
2BP
WHOOPING-COUGH VACCINATION
SiR,-The heated debate in Britain for or against whooping-cough vaccination seems puzzling on this side of the Atlantic. In the United States the incidence of pertussis has fallen in the past thirty years from some 120 000 cases per year to 1000-2000. And, while serious adverse reactions are known, I have yet to see one, although, as a public-health physician, I have over the years given or been responsible for at least 100 000 of these inoculations. There is little of the anxiety here, so prevalent in Britain about the whooping-cough vaccine, and in American medical j< ’rnals opposition to this immunisation is virtually non-existent. Are we overlooking veiled adverse effects? Are we dealing with a different product? Our combined diphtheria-pertussis-tetanus vaccine is certainly effective. In New Haven, a city of 140 000, we have had an average of 1 case of whooping-cough per year reported in the past ten years, and well over 85% of all children have received the vaccine, apparently without injury. I assume that the mode of administration is similar in Britain-i.e., it is given mainly in infancy and only up to the age of five. New Haven Health Department, New Haven, Connecticut 06511, U.S.A.
H. H. NEUMANN
was
7. Duncan, T., Care, A. D. Br. J. Surg. 1967, 54, 196. 1. Archs. Dis. Childh. 1973, 48, 751. 2. Constraints on the Advance of Medicine. Proc. R. Soc. Med. 1974, 67, 1311. 3. Royal College of Physicians Report on Ethics; p. 2. See Proc. R. Soc. Med.
1974, 67, 1308. 4. M.R.C. Statement on Medical Ethics Br. med. J. 1964, ii, 178. 5. Curran, W. J., Beecher, H. K. J. Am. med. Ass. 1969, 210, 77.
SALMONELLA MENINGITIS IN INFANTS
SIR,-In response to the report by Professor Denis and his colleagues (April 23, p. 910) of their experience in Senegal we would like to describe our experience of Salmonella meningitis in African children admitted to King Edward VIII Hospital during the period 1960-75. Among 3395 patients infected with various Salmonella enteritidis serotypes, 51 (1.5%) had Salmonella meningitis, including 6 caused by S. typhi. The
S. enteritidis serotype isolated from was typhimurium (see table). In 90% of cases meningitis was encountered in children less than a year old (median age three months), and the mortality-rate in the whole series was high (59%); most patients had other debilitating conditions such as malnutrition and bronchopneumonia. Treatment was with chloramphenicol, alone or in combination with gentamicin and/or sulphonamide; all drugs were most common
cerebrospinal
fluid
(c.s.F.)
Campbell, A. G. M. Br. med. J. 1974, iii, 334. 7. Harris, J. C. (retold by Jane Shaw). Uncle Remus Stories: Brer Rabbit and
6.
the Tar Baby.
pranolol treated patients, when osteodystrophic repair would be expected to be most active. Follow-up of these patients from four months onwards showed normal S.A.P. levels, irrespective of preoperative preparation.
thyrocalcitonin release may indeed play some part in explaining transient falls in serum-calcium after thyroid operations, we feel that proponents of this idea should back it by using highly sensitive immunoassays of calcitonin now available. We cannot agree, however, that hypocalczmia lasting longer than a day can be so explained, and we believe that the avidity of thyrotoxic osteodystrophic bone for calcium is then the best explanation. Furthermore the thyroids of pigs pretreated with methylthiouracil had an impaired ability to secrete calcitonin.5 This might help to explain why the fall in While
serum-calcium in the series of Wilkin et al. was of greater statistical significance in the patients with functionally normal non-toxic goitre. W. MICHIE Departments of Surgery, Medicine, and J. M. STOWERS Chemical Pathology, S. C. FRAZER of Aberdeen University
mean
investigation which is not for their benefit where the studies are sound, promise important new knowledge and there is no discernible risk", adding the necessity for informed parental consent.
Campbe1l6 states "the only real protection for the individual scrupulousness, conscience and personal integrity of the investigator." But individual conscience varies too, and who then decides what is negligible risk, discomfort, and "inlies in the
formed" consent? Ethical committees are admirable in concept but "they vary in their membership, their influence and in There is no consistent their interpretation of their role ...
policy."6 Perhaps any further guidelines have to wait until, as Sir Cyril Clarkes suggests, someone makes a test case with the backing of a medical defence body: but, should such support be wanting, what individual doctor, acting against legal and protessional advice, is going to risk his head on the chopping block and rely on an ethical committee’s decision to stop it tumbling off. "Tar-baby, she ain’t saying nothing-and Brer Fox, he still lay low!"’ Town Farm, West Street,
RESEARCH ON INFANTS
SIR,-I am grateful to Dr Gairdner for the references in his letter (April 16, p. 852) concerning blood-sampling in infants but I cannot agree with his suggestion that I "need not have left the matter there". I did not. The Medical Defence Union confirmed the advice of the paediatrician on the local ethical research committee (i.e., that blood-sampling for research in infants was not legally permissible), and cautioned me against proceeding with this. I then referred, at the suggestion of the British Medical Association, to Professor Oppe, professor of paediatrics, London University, who, informed of the circumstances, supported this view. Both knew that my research programme (to determine whether the type of early feeding is related to the incidence of asthma in children) involved following up babies at home in preference to hospital outpatients, and that this included regular bloodsampling for assessment of immunoglobulins and milk antibodies. As Dr Dodge and Dr Evans point out in their letter (April 16, p. 852) there are risks in blood-sampling, however slight, and, in view of the advice I had been given, it did not seem justifiable to me (a mother, a doctor, and a magistrate) to proceed with this, when, although immunoglobulin studies are relevant, they are not essential to what I am trying to establish. This was a "value judgement",’ as it happens by a woman. (I note that all the writings I have seen in support of blood-
sampling are by men!) research blood-sampling in general which letter. prompted my The views of authoritative bodies vary from the Department of Health view expressed by Sir George Godber2 that it is not legitimate to do experiments in children which are not in the interests of that particular child, to the Royal College of Physicians recommendation3 that "clinical research investigation of children ... which is not of direct benefit to the patient should be conducted, but only when the procedures entail negligible risk or discomfort and subject to the provisions of any common and statute law prevailing at the time. The parent or guardian should be consulted and his agreement recorded." The Medical Research Council statement4 questions the legal competence of parents to give such consent. The 1973 editorial in the Archives of Diseases in Childhood concurs with Curran and Beecher5 that "children under 14 may participate in clinical But it
Marlow, Bucks SL7
HELENOR PRATT
2BP
WHOOPING-COUGH VACCINATION
SiR,-The heated debate in Britain for or against whooping-cough vaccination seems puzzling on this side of the Atlantic. In the United States the incidence of pertussis has fallen in the past thirty years from some 120 000 cases per year to 1000-2000. And, while serious adverse reactions are known, I have yet to see one, although, as a public-health physician, I have over the years given or been responsible for at least 100 000 of these inoculations. There is little of the anxiety here, so prevalent in Britain about the whooping-cough vaccine, and in American medical j< ’rnals opposition to this immunisation is virtually non-existent. Are we overlooking veiled adverse effects? Are we dealing with a different product? Our combined diphtheria-pertussis-tetanus vaccine is certainly effective. In New Haven, a city of 140 000, we have had an average of 1 case of whooping-cough per year reported in the past ten years, and well over 85% of all children have received the vaccine, apparently without injury. I assume that the mode of administration is similar in Britain-i.e., it is given mainly in infancy and only up to the age of five. New Haven Health Department, New Haven, Connecticut 06511, U.S.A.
H. H. NEUMANN
was
7. Duncan, T., Care, A. D. Br. J. Surg. 1967, 54, 196. 1. Archs. Dis. Childh. 1973, 48, 751. 2. Constraints on the Advance of Medicine. Proc. R. Soc. Med. 1974, 67, 1311. 3. Royal College of Physicians Report on Ethics; p. 2. See Proc. R. Soc. Med.
1974, 67, 1308. 4. M.R.C. Statement on Medical Ethics Br. med. J. 1964, ii, 178. 5. Curran, W. J., Beecher, H. K. J. Am. med. Ass. 1969, 210, 77.
SALMONELLA MENINGITIS IN INFANTS
SIR,-In response to the report by Professor Denis and his colleagues (April 23, p. 910) of their experience in Senegal we would like to describe our experience of Salmonella meningitis in African children admitted to King Edward VIII Hospital during the period 1960-75. Among 3395 patients infected with various Salmonella enteritidis serotypes, 51 (1.5%) had Salmonella meningitis, including 6 caused by S. typhi. The
S. enteritidis serotype isolated from was typhimurium (see table). In 90% of cases meningitis was encountered in children less than a year old (median age three months), and the mortality-rate in the whole series was high (59%); most patients had other debilitating conditions such as malnutrition and bronchopneumonia. Treatment was with chloramphenicol, alone or in combination with gentamicin and/or sulphonamide; all drugs were most common
cerebrospinal
fluid
(c.s.F.)
Campbell, A. G. M. Br. med. J. 1974, iii, 334. 7. Harris, J. C. (retold by Jane Shaw). Uncle Remus Stories: Brer Rabbit and
6.
the Tar Baby.
