26
COMPENSATING THE DRUG VICTIM IN a statement last week’ the Royal College of Physicians contributes to the discussion, opened by a Royal Commission in March,2 about how those who are injured by drugs should be compensated. The College joins the Association of the British Pharmaceutical Industry in opposing the idea that the basis of compensation, at least for prescribed drugs, should be strict liability. Under strict liability it is enough to prove cause and effect; negligence is not an issue. The College makes a good case: it stresses the potential harm to the relationship between a doctor and his patient, the special problems that arise with idiosyncratic reactions, and the trend to defensive medicine that would ensue. The College prefers a no-fault scheme with injuries due to drugs compensated out of a fund financed, perhaps, by a levy on drug sales. This would be not unlike the Pearson scheme2for reducing road-traffic accident litigation, in which motorists would pay into a compensation fund via a special tax on petrol. We seem very close here to the controversial payment of compensation to those injured by, say, whooping-cough vaccine :3 the person who takes a drug causing illness gets money denied the patient in whom the same symptoms are spontaneous. It is tempting to argue that those who profit from drug manufacture, negligent or not, should pay when their products cause harm, but there is money in vaccines too, and the case for immunisation rests partly on the need to protect the population at large, an argument that hardly ever applies to drugs. An administratively simple system has a lot to commend it, but the safety a patient can reasonably expect from the product must, since all effective drugs are poisons in some measure, depend on the seriousness of the condition for which the drug was given. Neither this question of cost/benefit nor the establishment of cause and effect is any easier under a nofault scheme. Perhaps there is something to be said for the status quo-manufacturers’ liability to compensate if tests are omitted or done incorrectly, if results are withheld, or if the drug is badly made, for example, backed by strict drug-registration programmes and after-sales monitoring. Whatever the method of funding, the patient with the strongest case for compensation is the one injured by a drug prescribed for a trivial ailment, whether the root cause was hyperbolic advertising or thoughtless prescribing, both surely negligent actions.
BREAST RECONSTRUCTION FOR CANCER
"Reconstruction of the breast at mastectomy for cancer endangers the quality and length of the patient’s life. Cancer may be implanted in the extensively dissected operation site and the subsequent growth of implanted cells would be concealed by the prothesis or by the pectoralis major under which it has been introduced. Thus the excision or irradiation of local recurrences will be delayed, a warning of the expansion of distant metastases will be lost as will be the possibility of instituting systemic treatment at a time of low cancer burden." 1.
Paper prepared by the Royal College of Physicians of London in response to the Pearson Commission’s proposal to apply the principle of strict liability to
drugs. Royal College of Physicians, London NW1.
2. See Lancet, 1978, i, 644. 3. Lancet, 1977, ii, 910; ibid. 1978, i, 1028.
These would be the arguments of those opposed to primary reconstruction. They feel that a carefully chosen external prosthesis satisfies the majority of mastectomy patients, who are usually over 55 years old, and that a compromise upon the management of the chest wall would serve patients poorly. Some opponents also feel that concentration upon local reconstruction might distract attention from systemic treatments designed to suppress widespread micrometastases. The general view is that a well-balanced team or a single suitably skilled cancer surgeon can provide the best combination of local and systemic managements for each patient. Reconstructors, however, maintain that a proportion of mastectomy patients suffer prolonged anxiety and depression. Maguire and others’ indicate that as many as 39% have such problems one year after mastectomy, and a small subpopulation of these seem to be directly concerned about breast loss. And reconstructors also point to a lack of evidence that increased and hidden recurrences on the chest wall follow reconstruction. The published work on primary postmastectomy reconstruction of the breast concentrates upon surgical technique. There are no studies to guide the surgeon upon selection of the type of patient most suited to reconstruction. Psychiatric morbidity may well be avoidable without breast reconstruction in those at risk-if they can be identified. Unfortunately predictive criteria have not yet been defined. Scientific study of reconstruction is much needed. Factors which probably influence outcome include the ratio of cancer bulk to breast bulk, the site of tumour within the breast or its proximity to the chest wall or skin, and the presence of metastases in axillary nodes; and in any controlled trial these must be allowed for. Participants at a recent symposium organised by the Yorkshire Breast Cancer Group were told that only 7 of a Birmingham series of 200 patients treated by reconstruction had died during a follow-up of between three and ten years. The meaning of this is not clear since details of the important prognostic factors were not recorded, although Watts2 previously stated that patients were "mostly stage I". This 96-3% three-year survivorship is a remarkable claim since in 1941-60 the corrected Birmingham five-year survivorships were 80.5% (not irradiated) and 71-2% (irradiated) for 2051 node-negative (also mostly stage I) patients.3 American results are similar: in 2039 patients4 the three-year survivorship of all node-negative subjects was 85%, and in a stratification by tumour size even the most favourable
presentations-impalpable (microscopic) cancers up to those with a largest diameter of 2 cm-had three-year survivorships of only 90-95%, the comparable range of survivorship at five years being 84-88%. It seems highly unlikely that primary mammary reconstruction might induce a subtle host response with improved survival. However, there may well be some patients who are best served by reconstruction, and, if so, carefully designed prospective trials will enable us to identify them.
Maguire, G. P., et al., Br. med. J 1978, i, 963. Watts, G. T. Br. J. Surg. 1976, 63, 823. 3. Bond, W. H. The Treatment of Carcinoma of the Breast (edited by Jarrett); p. 32. Amsterdam, 1967. 4. Cutler, S. J., Myers, M. H.J. natn. Cancer Inst. 1967, 39, 193. 1. 2.
A S.
COMPENSATING THE DRUG VICTIM IN a statement last week’ the Royal College of Physicians contributes to the discussion, opened by a Royal Commission in March,2 about how those who are injured by drugs should be compensated. The College joins the Association of the British Pharmaceutical Industry in opposing the idea that the basis of compensation, at least for prescribed drugs, should be strict liability. Under strict liability it is enough to prove cause and effect; negligence is not an issue. The College makes a good case: it stresses the potential harm to the relationship between a doctor and his patient, the special problems that arise with idiosyncratic reactions, and the trend to defensive medicine that would ensue. The College prefers a no-fault scheme with injuries due to drugs compensated out of a fund financed, perhaps, by a levy on drug sales. This would be not unlike the Pearson scheme2for reducing road-traffic accident litigation, in which motorists would pay into a compensation fund via a special tax on petrol. We seem very close here to the controversial payment of compensation to those injured by, say, whooping-cough vaccine :3 the person who takes a drug causing illness gets money denied the patient in whom the same symptoms are spontaneous. It is tempting to argue that those who profit from drug manufacture, negligent or not, should pay when their products cause harm, but there is money in vaccines too, and the case for immunisation rests partly on the need to protect the population at large, an argument that hardly ever applies to drugs. An administratively simple system has a lot to commend it, but the safety a patient can reasonably expect from the product must, since all effective drugs are poisons in some measure, depend on the seriousness of the condition for which the drug was given. Neither this question of cost/benefit nor the establishment of cause and effect is any easier under a nofault scheme. Perhaps there is something to be said for the status quo-manufacturers’ liability to compensate if tests are omitted or done incorrectly, if results are withheld, or if the drug is badly made, for example, backed by strict drug-registration programmes and after-sales monitoring. Whatever the method of funding, the patient with the strongest case for compensation is the one injured by a drug prescribed for a trivial ailment, whether the root cause was hyperbolic advertising or thoughtless prescribing, both surely negligent actions.
BREAST RECONSTRUCTION FOR CANCER
"Reconstruction of the breast at mastectomy for cancer endangers the quality and length of the patient’s life. Cancer may be implanted in the extensively dissected operation site and the subsequent growth of implanted cells would be concealed by the prothesis or by the pectoralis major under which it has been introduced. Thus the excision or irradiation of local recurrences will be delayed, a warning of the expansion of distant metastases will be lost as will be the possibility of instituting systemic treatment at a time of low cancer burden." 1.
Paper prepared by the Royal College of Physicians of London in response to the Pearson Commission’s proposal to apply the principle of strict liability to
drugs. Royal College of Physicians, London NW1.
2. See Lancet, 1978, i, 644. 3. Lancet, 1977, ii, 910; ibid. 1978, i, 1028.
These would be the arguments of those opposed to primary reconstruction. They feel that a carefully chosen external prosthesis satisfies the majority of mastectomy patients, who are usually over 55 years old, and that a compromise upon the management of the chest wall would serve patients poorly. Some opponents also feel that concentration upon local reconstruction might distract attention from systemic treatments designed to suppress widespread micrometastases. The general view is that a well-balanced team or a single suitably skilled cancer surgeon can provide the best combination of local and systemic managements for each patient. Reconstructors, however, maintain that a proportion of mastectomy patients suffer prolonged anxiety and depression. Maguire and others’ indicate that as many as 39% have such problems one year after mastectomy, and a small subpopulation of these seem to be directly concerned about breast loss. And reconstructors also point to a lack of evidence that increased and hidden recurrences on the chest wall follow reconstruction. The published work on primary postmastectomy reconstruction of the breast concentrates upon surgical technique. There are no studies to guide the surgeon upon selection of the type of patient most suited to reconstruction. Psychiatric morbidity may well be avoidable without breast reconstruction in those at risk-if they can be identified. Unfortunately predictive criteria have not yet been defined. Scientific study of reconstruction is much needed. Factors which probably influence outcome include the ratio of cancer bulk to breast bulk, the site of tumour within the breast or its proximity to the chest wall or skin, and the presence of metastases in axillary nodes; and in any controlled trial these must be allowed for. Participants at a recent symposium organised by the Yorkshire Breast Cancer Group were told that only 7 of a Birmingham series of 200 patients treated by reconstruction had died during a follow-up of between three and ten years. The meaning of this is not clear since details of the important prognostic factors were not recorded, although Watts2 previously stated that patients were "mostly stage I". This 96-3% three-year survivorship is a remarkable claim since in 1941-60 the corrected Birmingham five-year survivorships were 80.5% (not irradiated) and 71-2% (irradiated) for 2051 node-negative (also mostly stage I) patients.3 American results are similar: in 2039 patients4 the three-year survivorship of all node-negative subjects was 85%, and in a stratification by tumour size even the most favourable
presentations-impalpable (microscopic) cancers up to those with a largest diameter of 2 cm-had three-year survivorships of only 90-95%, the comparable range of survivorship at five years being 84-88%. It seems highly unlikely that primary mammary reconstruction might induce a subtle host response with improved survival. However, there may well be some patients who are best served by reconstruction, and, if so, carefully designed prospective trials will enable us to identify them.
Maguire, G. P., et al., Br. med. J 1978, i, 963. Watts, G. T. Br. J. Surg. 1976, 63, 823. 3. Bond, W. H. The Treatment of Carcinoma of the Breast (edited by Jarrett); p. 32. Amsterdam, 1967. 4. Cutler, S. J., Myers, M. H.J. natn. Cancer Inst. 1967, 39, 193. 1. 2.
A S.
