- Email: [email protected]
HUMAN EXPERIMENTATION
252
of smoke and sulphur dioxide by a standard method. These daily measurements (made at nearly 1200 places in 1966) should give valuable clues to the types of pollution which can cause respiratory disease. Levels and types of pollution are changing. It is important to learn whether these changes affect the level and type of disease; and, for this, the many variables, such as cigarette smoking, infection, and change in social conditions, will have to be disentangled. The report contains a concise account of the differences in pattern of pollution and the decrease in smoke concentration between the 1952 and 1962 London smog episodes. The cautious comment that the reduction in the excess number of deaths to about 700 in 1962 (from 4000 in 1952) may not have been due solely to the change in smoke concentration is almost certainly correct. But it is sad to reflect that in this, as in much else concerning air pollution, there is no certainty.
measurements
HUMAN EXPERIMENTATION
FOR ages, the relationship between doctor and patient has been guided by a set of principles which, though consistent with the highest Christian ideals, was actually inherited from earlier civilisations. Advances in medical research, however, have now produced situations for which these principles give no clear guidance. In a University of London lecture on July 14 Prof. W. B. Bean remarked how new techniques of cardiac massage and resuscitation could maintain a life which was little more than vegetative. In the use of renal dialysis, a doctor or committee of doctors and laymen sat in judgment to decide who was to live or die. In organ transplantation, too, new patient-doctor relationships had been produced. In particular, the organ donor was either a normal healthy person or a cadaver and was not in a therapeutic relationship with the doctor at that time. The responsibilities involved had not yet been clearly defined. Professor Bean was especially concerned with the ethics of human experimentation. Although, in a real sense, every dose of a drug and every surgical procedure was an " experiment", medical research usually involved the introduction of controlled changes in some part of the patient’s physiological state and accurate observation of the results. Such research must involve risk, however small, and this means, in Bean’s view, firstly, that it was the doctor’s moral responsibility so to design his experiment that useless duplication or waste of material was eliminated; and, secondly, that informed consent should be obtained from patient or relative before the experiment began. There were obvious difficulties in defining informed consent, concerning both the patient’s ability to understand the situation and the doctor’s own limitations in communicating with the patient or foreseeing the outcome of the research project. Nevertheless the principle remained. Bean also suggested that a group of the doctor’s peers should scrutinise his project so that as many risks as possible were eliminated and the fullest information obtained. Such scrutiny would allow a feedback of ideas and constructive criticism. This idea has lately been discussed widely, and such local scrutinising committees will no doubt be established in many institutions. Should the research doctor be in direct therapeutic relationship with the patient, or should he be part of a separate academic research department ? Although Sir Thomas Lewis had favoured the second arrangement,1 1. Br. med.
J. 1920, ii, 459.
Bean believed that the best situation was that in which the patient regarded the research-worker as a member of the therapeutic team responsible for his care, and that the doctor had an overriding concern for the ultimate wellbeing of his patient which would always temper his research enthusiasm. Discussing the present attitude towards human experimentation, Professor Bean said research-workers seemed to be on the defensive in the face of widespread assumptions that there was something inherently wrong in their work. He suggested that this may be part of a general abhorrence of subjecting living creatures, including animals, to unnecessary pain, and it may also reflect continuing collective guilt feelings associated with the Nazi experiments during the 1939-45 war. Whatever the cause, the basic issue seems clear: a new interpetation of medical ethics must develop to guide a doctor into this revolutionary era of medical practice. Legislation, Bean insisted, was undesirable; it is unlikely, as we said2a few weeks ago, that any legal machinery can safeguard the patient more than the non-statutory scrutiny of a research
project by independent colleagues.
NON-DISEASE OF THE HEART
THE late Dr. Charles Camerson maintained, quite correctly, that health is an exclusion diagnosis, and only those with a profound knowledge of disease are in a position to diagnose health. There can be no doubt that this applies to diseases of the heart, and for many years large numbers of children had their activity quite unnecessarily restricted. Before the 1939-45 war, the L.C.C. had an extensive and expensive organisation for with rheumatic fever, and a cynic remarked that dealing " the only thing which seemed to justify the cost of the scheme was the excellent results obtained in the majority of the children who never had nor ever developed rheumatic fever ". Matters have improved greatly since then; but errors have not completely disappeared. Bergman and Stamm3 reviewed the records of 20,500 children in Seattle schools, and found that 110 of them were supposed to have something wrong with the heart ". They were able to examine and study 93 of these children, and they found that 18 had significant heart-disease, either congenital or rheumatic, while the other 75 were shown to have " no present evidence " of heart-disease. The second group " they refer to as cardiac non-disease ". They found that 6 of the children with cardiac disease and 30 with cardiac non-disease were quite unnecessarily restricted in their activity, and they went into the details of how this had come about. Unhappily, 53% of children were restricted on medical advice. Of the remainder the restriction was caused by the parents’ confusion about the advice they had been given, or because they thought their children "
entirely healthy. Bergman and Stamm point out that, in this survey, the disability from cardiac non-disease was greater than that from actual heart-disease; and this is a sharp reminder that very careful judgment is needed before a child’s activity is restricted because of possible heart-disease. Moreover, parents must be left in no doubt at all about what advice is being given and why. were not
2. 3.
Lancet, 1967, i, 1144. Bergman, A. B., Stamm, S. J.
New
Engl. J. Med. 1967, 276,
1008.
of smoke and sulphur dioxide by a standard method. These daily measurements (made at nearly 1200 places in 1966) should give valuable clues to the types of pollution which can cause respiratory disease. Levels and types of pollution are changing. It is important to learn whether these changes affect the level and type of disease; and, for this, the many variables, such as cigarette smoking, infection, and change in social conditions, will have to be disentangled. The report contains a concise account of the differences in pattern of pollution and the decrease in smoke concentration between the 1952 and 1962 London smog episodes. The cautious comment that the reduction in the excess number of deaths to about 700 in 1962 (from 4000 in 1952) may not have been due solely to the change in smoke concentration is almost certainly correct. But it is sad to reflect that in this, as in much else concerning air pollution, there is no certainty.
measurements
HUMAN EXPERIMENTATION
FOR ages, the relationship between doctor and patient has been guided by a set of principles which, though consistent with the highest Christian ideals, was actually inherited from earlier civilisations. Advances in medical research, however, have now produced situations for which these principles give no clear guidance. In a University of London lecture on July 14 Prof. W. B. Bean remarked how new techniques of cardiac massage and resuscitation could maintain a life which was little more than vegetative. In the use of renal dialysis, a doctor or committee of doctors and laymen sat in judgment to decide who was to live or die. In organ transplantation, too, new patient-doctor relationships had been produced. In particular, the organ donor was either a normal healthy person or a cadaver and was not in a therapeutic relationship with the doctor at that time. The responsibilities involved had not yet been clearly defined. Professor Bean was especially concerned with the ethics of human experimentation. Although, in a real sense, every dose of a drug and every surgical procedure was an " experiment", medical research usually involved the introduction of controlled changes in some part of the patient’s physiological state and accurate observation of the results. Such research must involve risk, however small, and this means, in Bean’s view, firstly, that it was the doctor’s moral responsibility so to design his experiment that useless duplication or waste of material was eliminated; and, secondly, that informed consent should be obtained from patient or relative before the experiment began. There were obvious difficulties in defining informed consent, concerning both the patient’s ability to understand the situation and the doctor’s own limitations in communicating with the patient or foreseeing the outcome of the research project. Nevertheless the principle remained. Bean also suggested that a group of the doctor’s peers should scrutinise his project so that as many risks as possible were eliminated and the fullest information obtained. Such scrutiny would allow a feedback of ideas and constructive criticism. This idea has lately been discussed widely, and such local scrutinising committees will no doubt be established in many institutions. Should the research doctor be in direct therapeutic relationship with the patient, or should he be part of a separate academic research department ? Although Sir Thomas Lewis had favoured the second arrangement,1 1. Br. med.
J. 1920, ii, 459.
Bean believed that the best situation was that in which the patient regarded the research-worker as a member of the therapeutic team responsible for his care, and that the doctor had an overriding concern for the ultimate wellbeing of his patient which would always temper his research enthusiasm. Discussing the present attitude towards human experimentation, Professor Bean said research-workers seemed to be on the defensive in the face of widespread assumptions that there was something inherently wrong in their work. He suggested that this may be part of a general abhorrence of subjecting living creatures, including animals, to unnecessary pain, and it may also reflect continuing collective guilt feelings associated with the Nazi experiments during the 1939-45 war. Whatever the cause, the basic issue seems clear: a new interpetation of medical ethics must develop to guide a doctor into this revolutionary era of medical practice. Legislation, Bean insisted, was undesirable; it is unlikely, as we said2a few weeks ago, that any legal machinery can safeguard the patient more than the non-statutory scrutiny of a research
project by independent colleagues.
NON-DISEASE OF THE HEART
THE late Dr. Charles Camerson maintained, quite correctly, that health is an exclusion diagnosis, and only those with a profound knowledge of disease are in a position to diagnose health. There can be no doubt that this applies to diseases of the heart, and for many years large numbers of children had their activity quite unnecessarily restricted. Before the 1939-45 war, the L.C.C. had an extensive and expensive organisation for with rheumatic fever, and a cynic remarked that dealing " the only thing which seemed to justify the cost of the scheme was the excellent results obtained in the majority of the children who never had nor ever developed rheumatic fever ". Matters have improved greatly since then; but errors have not completely disappeared. Bergman and Stamm3 reviewed the records of 20,500 children in Seattle schools, and found that 110 of them were supposed to have something wrong with the heart ". They were able to examine and study 93 of these children, and they found that 18 had significant heart-disease, either congenital or rheumatic, while the other 75 were shown to have " no present evidence " of heart-disease. The second group " they refer to as cardiac non-disease ". They found that 6 of the children with cardiac disease and 30 with cardiac non-disease were quite unnecessarily restricted in their activity, and they went into the details of how this had come about. Unhappily, 53% of children were restricted on medical advice. Of the remainder the restriction was caused by the parents’ confusion about the advice they had been given, or because they thought their children "
entirely healthy. Bergman and Stamm point out that, in this survey, the disability from cardiac non-disease was greater than that from actual heart-disease; and this is a sharp reminder that very careful judgment is needed before a child’s activity is restricted because of possible heart-disease. Moreover, parents must be left in no doubt at all about what advice is being given and why. were not
2. 3.
Lancet, 1967, i, 1144. Bergman, A. B., Stamm, S. J.
New
Engl. J. Med. 1967, 276,
1008.