644
which results in intracellular migration of water, is of limited value; and loading with hypertonic saline confers only transient benefit to patients with tumour secretion of A.D.H. But both lithium and demeclocycline enhance renal excretion of water, probably by inhibiting the renal tubular action of antidiuretic hormone." Both cause serum-sodium to rise in hyponatrsemic patients. Probably demeclocycline is preferable since it is less toxic and the effect is dose dependent in the range 600-1200 mg a day.12 When should hyponatraemia be treated? Attempts with demeclocycline at correction of hyponatraemia due to cirrhosis of the liver have adversely affected renal function.13 Here the matter of definition becomes critical. Hyponatraemia due to tumour secretion of antidiuretic hormone often causes symptoms and does require treatment with drugs.l3 But in other systemic illnesses such as cirrhosis and congestive cardiac failure the symptoms are less obviously due to low sodium: the primary disease may explain all the symptoms, and some water retention may even be beneficial. In such situations the temptation to give normal or hypertonic saline should be resisted. These differences in management add weight to the view that the term "inappropriate secretion of A.D.H." should be restricted to tumour secretion of A.D.H., where pathogenesis and treatment are distinct from the other more common causes of hyponatrsemia. COMPENSATION AND CLAPHAM MAN THE passenger on a Clapham omnibus, to whom lawyers traditionally turn when they seek common sense and reasonableness, would probably accept that the slingshots and arrows that occasionally fall upon him and his family can be propelled by man or by the gods. He may seek retribution for the one while accepting social security for the other. This is a recurrent theme in the report from Lord Pearson and his colleagues (vol. i of which will suffice for the hard-pressed).1 Time and again the Royal Commission toys with the idea of doing away with the need to go to law to prove duty of care, negligence, and cause and effect, if damages for personal injury are sought. Usually, though, they reject the idea, sometimes with dissenting opinions with which this massive report is liberally strewn. If the recommendations are acted on there will be a shift, in the way the British citizen seeks compensation for hardship and suffering brought on by an injury, from redress in the courts to social security. After reconstruction of the formulae on which damages are calculated, extension of the types of injury that social security can provide for, and removal of double compensation, the number of minor actions for damages should fall. More than three-quarters of actions for 11. Singer, I., Forrest, J. N. Kidney Int. 1976, 10, 82. 12. Forrest, J. N., Cox, M., Hong, L., Morrison, G.,
Bia, M., Singer, I. New Engl. J. Med. 1978, 298, 173. 13. Oster, J. R., Epstein, M., Ulano, H. B. Curr. Ther. Res. 1976, 20, 794. 1. Royal Commission on Civil Liability and Compensation for Personal Injury. Cmnd 7054. H.M. Stationery Office. Vol. I, pp. 545, £7.60; vol. II (statistics and costings), pp. 259, £3.60; vol. III (overseas systems of compensation), pp. 280, £3.60.
damages that succeed end in payments of less than £1000. Given the massive social-security bill the taxpayer now foots, the extra amount should not be politically controversial; nor anyway are these proposals as dramatic as they sound, for half the money paid out for injury compensation comes from the State already, compared with a quarter through the courts. The proposal that has attracted most attention is the "no fault" compensation scheme for injury in road-traffic accidents, paid for by a levy of lp on every gallon of petrol which would be passed on to the Department of Social Security who would run the scheme, benefits being paid out along the lines of those for industrial injuries. The industrial injuries scheme itself would be made more generous and extended to cover travel to and from work, the self-employed, and additional cases of occupational disease. The freedom to sue for damages over and above these provisions would be retained. This strategy of shifting the burden to the Welfare State has already been criticised; but the critics, says the Royal Commission, have not grasped the extent of current payments under statutory provisions. The recommendations that more directly affect the health professions are significant in number but not in weight when set beside the massive problems of work and traffic injury. When the Government seemed to be agreeing to special compensation for vaccine-damaged children The Lancet2 argued that this would be wrong: no differentiation should be made between one type of physical or mental handicap and another. Lord Pearson and his colleagues get out of this difficulty by, on their own admission, straying beyond their remit and recommending a further allowance of 4 a week to be paid to the parents of any child with severe handicap. But parents who think that handicap has been caused by a vaccination given on the recommendation of the State would have a further remedy. At present they can obtain redress in the courts only by proving negligence: Lord Pearson and his colleagues recommend that such parents be allowed to proceed against the health authorities on the basis of strict liability (the sort of liability now laid upon those who run nuclear installations or keep tigers in their gardens); it would be enough to prove cause and effect, and negligence need not be demonstrated. The cause-and-effect provision is going to make for a lot of disappointment, perhaps for a majority of those who get into the files of the Association of Parents of Vaccine Damaged Children, and the tiny minority that might succeed would be set apart from the vast majority of handicapped children for whom no cause, let alone blame, can be allocated. There is a wider issue too. Immunisation programmes are just part of an approach to health based on preventing rather than curing. Up to now Government and its agents have not been specific, but is it too fanciful to ask how Lord Pearson would answer the widow whose middle-aged husband died while jogging, on the recommendation of the Health Education Council? The drug thalidomide was one of the reasons for setting up this inquiry. Drugs are products, and the Royal Commission follows the European line by urging that strict liability should prevail in the U.K. and that drugs should be no exception; the Association of the British 2. Lancet,
1977, ii, 910.
645
Pharmaceutical Industry opposes. The fact that
a drug might be in a state of development would be no defence, nor would approval by the Medicines Commission; there would be no limit on the amount that might be awarded; and if a drug was prescribed after the manufacturers had tried to withdraw it they would still be liable. The test would be that a drug could be held defective "when it does not provide the safety which a person is entitled to expect, having regard to all the circumstances including the presentation of the product". When the product is a ladder with a badly made rung this seems clear enough, but there was nothing wrong with the molecular bonds in 4’-(2-hydroxy-3-isopropylaminopropoxy) acetanilide (’Eraldin’, practolol) or with the manufacturers’ development of it. At the Press conference Lord Pearson implied that practolol victims would have had a case, had his suggestions been in force, but that those experiencing an unusual though recognised reaction to an established drug would not. And what of the wellmade oral contraceptive that cannot yet be said to be either "known" or "unknown" to cause circulatory troubles in a minority of women who take it? Every inroad into the pharmaceutical industry’s domain brings
the protest that innovation will be slowed; unless the of how the industry can get insurance against incalculable catastrophe can be resolved they may, this time, be right. Malpraxis insurance, an aspect discussed in detail by our Parliamentary correspondent (p. 674), would remain intact. The only change here relates to medical research: if something goes wrong a volunteer would have the right of action, under strict liability, against the authority responsible for the research. Another area of concern to doctors covered by the Pearson Commission is antenatal injury. The commissioners were unhappy about the Congenital Disabilities (Civil Liability) Bill, and Lord Pearson wrote to The Times about it. It implied far greater knowledge of the causes of such disabilities than anyone could claim. No major change is proposed, however, except that the father should be excluded from the provisions (the mother already is), a proposal that will be welcomed by all concerned with the integrity of the family. A thorough report this, and one needing much thought. The impact on public expenditure, insurance companies’ profits, and lawyers’ incomes is likely to be trivial. It would be a pity if such considerations were to dominate the debate on the Pearson proposals.
question
BLOOD-PRESSURE CONTROL AT HOME AND IN HOSPITAL
severity of vascular complications in untreated hypertension correlates with the level of the blood-pressure.’-4 Antihypertensive therapy reduces the incidence of stroke and congestive heart-failure5,6 and may reduce THE
the incidence of myocardial infarction.7 Electrocardiographic evidence of left ventricular hypertrophy (E.C.G.-L.v.H.) based on voltage criteria correlates with cardiac weight in hearts with L.V.H.8 Changes in the ST segment and T wave may reflect associated myocardial ischaemia or be secondary to the increasing magnitude of the QRS vector.9 Evidence of left ventricular hypertrophy on the electrocardiogram, even in the absence of other overt heart-disease, carries an adverse prognosis. 10 George et al.11 found that E.C.G.-L.V.H., as measured by max SVI + max RV5/6 greater than 45 mm, correlated with systolic pressure in severe hypertensives, and that with treatment the two regressed together. They concluded that this index of systolic-pressure control was a useful guide to the effectiveness of treatment. But other workers have reported discrepancies between pressure control and signs of E.C.G.-L.V.H. 12 For example, in some patients, clinic blood-pressures are high and resistant to therapy, yet E.C.G.-L.V.H. is absent. In a small group of such patients comparison of clinic readings with continuous intra-arterial pressure recordings showed that the clinic levels were considerably higher than the 24-hour pressures.13 Now Ibrahim and others 14 have tried another approach-retrospective comparison of clinic recordings with average weekly pressures as measured by the patient with a mercury sphygmomanometer at home. Fifty subjects were selected from the hypertension clinic. Forty-two had essential hypertension, six had renal-artery disease, and one each had Conn’s syndrome and chronic renal disease. Their mean age was 50-7 years and they were chosen from patients who had had an E.C.G. before and at least 2 years (mean 9 years) after the start of therapy. Blood-pressure control was graded as excellent (< 149/89 mm Hg), fair (150/90-169/99 mm Hg), or mm Hg). Changes in E.c.G.-L.v.H. (max poor (< 170/100 + max RV5/) were classified as complete or partial S, if more than 5 mm. Changes below 5 mm were ignored as possibly reflecting altered chest-wall thickness. Before therapy both systolic and diastolic pressures were higher in the clinic (193/118 ± 4/2 mm Hg) than at home (161/102 ± 3.4/2.2 mm Hg). During follow-up on treatment, the difference persisted for diastolic levels alone. However, both clinic (148/97 ± 41/2-2 mm Hg) and home (140/87 ± 3.3/1.5 mm Hg) readings had dropped significantly on treatment. Thirty patients initially had E.C.G.-L.v.H. and twelve reverted to normal. The voltage decreased or remained unchanged in fifteen and increased in one; two acquired a left anterior hemiblock. Of the twenty patients who did not have L.v.H., sixteen showed no change or a decline in voltage, one showed an increase, and three progressed to L.V.H. The E.C.G. improvement was more striking in those with a recent onset of hypertension and a lower pretreatment heart rate. When control had been excellent or fair at 7.
Berglund, G., Sannerstedt, R., Anderson, O., Wedel, H., Wilhelmsen, L., Hansson, L., Silvertsson, R., Wikstrand, J. Lancet, 1978, i, 1.
1. Pickering, G. W., Cranston, W. I., Pears, M. A. The Treatment of Hypertension. Springfield, Illinois, 1961. 2. Kannel, W. B. Prog. cardiovasc. Dis. 1974, 17, 5. 3. Smirk, F. H.N.Z. med. J. 1964, 63, 413. 4. Sokolow, M., Werdegar, D., Kain, H. K., Hinman, A. T. Circulation, 1966, on
Antihypertensive
8. Carter, W. A., Estes, E. H. Am. Heart J. 1964, 68, 173. 9. Cosby, R. S., Herman, L. M. ibid. 1961, 63, 180. 10. Kannel, W. B., Gordon, T., Offutt, D. Ann. intern. Med. 1969, 71, 89. 11. George, C. F., Breckenridge, A. M., Dollery, C. T. Br. Heart J. 1972, 34, 618. 12. Poblete, P. F., Kyle, M. C., Pipberger, H. V. Circulation, 1973, 48, 481. 13. Littler, W. A., Honour, A. J., Pageley, D. J., Sleight, P. Postgrad. med. J.
on
Antihypertensive
14.
34, 279. 5. Veterans Administration
Cooperative Study Group Agents. J.Am. med. Ass. 1967, 202, 1028. 6. Veterans Administration Cooperative Study Group Agents, ibid. 1970, 213, 1143.
1976, 52, suppl. 7, p. 119. Ibrahim, M. M., Teraji, R. C., Dustan, H. P., Gifford, R. Med. 1977, 137, 1125.
W. Archs intern.
which results in intracellular migration of water, is of limited value; and loading with hypertonic saline confers only transient benefit to patients with tumour secretion of A.D.H. But both lithium and demeclocycline enhance renal excretion of water, probably by inhibiting the renal tubular action of antidiuretic hormone." Both cause serum-sodium to rise in hyponatrsemic patients. Probably demeclocycline is preferable since it is less toxic and the effect is dose dependent in the range 600-1200 mg a day.12 When should hyponatraemia be treated? Attempts with demeclocycline at correction of hyponatraemia due to cirrhosis of the liver have adversely affected renal function.13 Here the matter of definition becomes critical. Hyponatraemia due to tumour secretion of antidiuretic hormone often causes symptoms and does require treatment with drugs.l3 But in other systemic illnesses such as cirrhosis and congestive cardiac failure the symptoms are less obviously due to low sodium: the primary disease may explain all the symptoms, and some water retention may even be beneficial. In such situations the temptation to give normal or hypertonic saline should be resisted. These differences in management add weight to the view that the term "inappropriate secretion of A.D.H." should be restricted to tumour secretion of A.D.H., where pathogenesis and treatment are distinct from the other more common causes of hyponatrsemia. COMPENSATION AND CLAPHAM MAN THE passenger on a Clapham omnibus, to whom lawyers traditionally turn when they seek common sense and reasonableness, would probably accept that the slingshots and arrows that occasionally fall upon him and his family can be propelled by man or by the gods. He may seek retribution for the one while accepting social security for the other. This is a recurrent theme in the report from Lord Pearson and his colleagues (vol. i of which will suffice for the hard-pressed).1 Time and again the Royal Commission toys with the idea of doing away with the need to go to law to prove duty of care, negligence, and cause and effect, if damages for personal injury are sought. Usually, though, they reject the idea, sometimes with dissenting opinions with which this massive report is liberally strewn. If the recommendations are acted on there will be a shift, in the way the British citizen seeks compensation for hardship and suffering brought on by an injury, from redress in the courts to social security. After reconstruction of the formulae on which damages are calculated, extension of the types of injury that social security can provide for, and removal of double compensation, the number of minor actions for damages should fall. More than three-quarters of actions for 11. Singer, I., Forrest, J. N. Kidney Int. 1976, 10, 82. 12. Forrest, J. N., Cox, M., Hong, L., Morrison, G.,
Bia, M., Singer, I. New Engl. J. Med. 1978, 298, 173. 13. Oster, J. R., Epstein, M., Ulano, H. B. Curr. Ther. Res. 1976, 20, 794. 1. Royal Commission on Civil Liability and Compensation for Personal Injury. Cmnd 7054. H.M. Stationery Office. Vol. I, pp. 545, £7.60; vol. II (statistics and costings), pp. 259, £3.60; vol. III (overseas systems of compensation), pp. 280, £3.60.
damages that succeed end in payments of less than £1000. Given the massive social-security bill the taxpayer now foots, the extra amount should not be politically controversial; nor anyway are these proposals as dramatic as they sound, for half the money paid out for injury compensation comes from the State already, compared with a quarter through the courts. The proposal that has attracted most attention is the "no fault" compensation scheme for injury in road-traffic accidents, paid for by a levy of lp on every gallon of petrol which would be passed on to the Department of Social Security who would run the scheme, benefits being paid out along the lines of those for industrial injuries. The industrial injuries scheme itself would be made more generous and extended to cover travel to and from work, the self-employed, and additional cases of occupational disease. The freedom to sue for damages over and above these provisions would be retained. This strategy of shifting the burden to the Welfare State has already been criticised; but the critics, says the Royal Commission, have not grasped the extent of current payments under statutory provisions. The recommendations that more directly affect the health professions are significant in number but not in weight when set beside the massive problems of work and traffic injury. When the Government seemed to be agreeing to special compensation for vaccine-damaged children The Lancet2 argued that this would be wrong: no differentiation should be made between one type of physical or mental handicap and another. Lord Pearson and his colleagues get out of this difficulty by, on their own admission, straying beyond their remit and recommending a further allowance of 4 a week to be paid to the parents of any child with severe handicap. But parents who think that handicap has been caused by a vaccination given on the recommendation of the State would have a further remedy. At present they can obtain redress in the courts only by proving negligence: Lord Pearson and his colleagues recommend that such parents be allowed to proceed against the health authorities on the basis of strict liability (the sort of liability now laid upon those who run nuclear installations or keep tigers in their gardens); it would be enough to prove cause and effect, and negligence need not be demonstrated. The cause-and-effect provision is going to make for a lot of disappointment, perhaps for a majority of those who get into the files of the Association of Parents of Vaccine Damaged Children, and the tiny minority that might succeed would be set apart from the vast majority of handicapped children for whom no cause, let alone blame, can be allocated. There is a wider issue too. Immunisation programmes are just part of an approach to health based on preventing rather than curing. Up to now Government and its agents have not been specific, but is it too fanciful to ask how Lord Pearson would answer the widow whose middle-aged husband died while jogging, on the recommendation of the Health Education Council? The drug thalidomide was one of the reasons for setting up this inquiry. Drugs are products, and the Royal Commission follows the European line by urging that strict liability should prevail in the U.K. and that drugs should be no exception; the Association of the British 2. Lancet,
1977, ii, 910.
645
Pharmaceutical Industry opposes. The fact that
a drug might be in a state of development would be no defence, nor would approval by the Medicines Commission; there would be no limit on the amount that might be awarded; and if a drug was prescribed after the manufacturers had tried to withdraw it they would still be liable. The test would be that a drug could be held defective "when it does not provide the safety which a person is entitled to expect, having regard to all the circumstances including the presentation of the product". When the product is a ladder with a badly made rung this seems clear enough, but there was nothing wrong with the molecular bonds in 4’-(2-hydroxy-3-isopropylaminopropoxy) acetanilide (’Eraldin’, practolol) or with the manufacturers’ development of it. At the Press conference Lord Pearson implied that practolol victims would have had a case, had his suggestions been in force, but that those experiencing an unusual though recognised reaction to an established drug would not. And what of the wellmade oral contraceptive that cannot yet be said to be either "known" or "unknown" to cause circulatory troubles in a minority of women who take it? Every inroad into the pharmaceutical industry’s domain brings
the protest that innovation will be slowed; unless the of how the industry can get insurance against incalculable catastrophe can be resolved they may, this time, be right. Malpraxis insurance, an aspect discussed in detail by our Parliamentary correspondent (p. 674), would remain intact. The only change here relates to medical research: if something goes wrong a volunteer would have the right of action, under strict liability, against the authority responsible for the research. Another area of concern to doctors covered by the Pearson Commission is antenatal injury. The commissioners were unhappy about the Congenital Disabilities (Civil Liability) Bill, and Lord Pearson wrote to The Times about it. It implied far greater knowledge of the causes of such disabilities than anyone could claim. No major change is proposed, however, except that the father should be excluded from the provisions (the mother already is), a proposal that will be welcomed by all concerned with the integrity of the family. A thorough report this, and one needing much thought. The impact on public expenditure, insurance companies’ profits, and lawyers’ incomes is likely to be trivial. It would be a pity if such considerations were to dominate the debate on the Pearson proposals.
question
BLOOD-PRESSURE CONTROL AT HOME AND IN HOSPITAL
severity of vascular complications in untreated hypertension correlates with the level of the blood-pressure.’-4 Antihypertensive therapy reduces the incidence of stroke and congestive heart-failure5,6 and may reduce THE
the incidence of myocardial infarction.7 Electrocardiographic evidence of left ventricular hypertrophy (E.C.G.-L.v.H.) based on voltage criteria correlates with cardiac weight in hearts with L.V.H.8 Changes in the ST segment and T wave may reflect associated myocardial ischaemia or be secondary to the increasing magnitude of the QRS vector.9 Evidence of left ventricular hypertrophy on the electrocardiogram, even in the absence of other overt heart-disease, carries an adverse prognosis. 10 George et al.11 found that E.C.G.-L.V.H., as measured by max SVI + max RV5/6 greater than 45 mm, correlated with systolic pressure in severe hypertensives, and that with treatment the two regressed together. They concluded that this index of systolic-pressure control was a useful guide to the effectiveness of treatment. But other workers have reported discrepancies between pressure control and signs of E.C.G.-L.V.H. 12 For example, in some patients, clinic blood-pressures are high and resistant to therapy, yet E.C.G.-L.V.H. is absent. In a small group of such patients comparison of clinic readings with continuous intra-arterial pressure recordings showed that the clinic levels were considerably higher than the 24-hour pressures.13 Now Ibrahim and others 14 have tried another approach-retrospective comparison of clinic recordings with average weekly pressures as measured by the patient with a mercury sphygmomanometer at home. Fifty subjects were selected from the hypertension clinic. Forty-two had essential hypertension, six had renal-artery disease, and one each had Conn’s syndrome and chronic renal disease. Their mean age was 50-7 years and they were chosen from patients who had had an E.C.G. before and at least 2 years (mean 9 years) after the start of therapy. Blood-pressure control was graded as excellent (< 149/89 mm Hg), fair (150/90-169/99 mm Hg), or mm Hg). Changes in E.c.G.-L.v.H. (max poor (< 170/100 + max RV5/) were classified as complete or partial S, if more than 5 mm. Changes below 5 mm were ignored as possibly reflecting altered chest-wall thickness. Before therapy both systolic and diastolic pressures were higher in the clinic (193/118 ± 4/2 mm Hg) than at home (161/102 ± 3.4/2.2 mm Hg). During follow-up on treatment, the difference persisted for diastolic levels alone. However, both clinic (148/97 ± 41/2-2 mm Hg) and home (140/87 ± 3.3/1.5 mm Hg) readings had dropped significantly on treatment. Thirty patients initially had E.C.G.-L.v.H. and twelve reverted to normal. The voltage decreased or remained unchanged in fifteen and increased in one; two acquired a left anterior hemiblock. Of the twenty patients who did not have L.v.H., sixteen showed no change or a decline in voltage, one showed an increase, and three progressed to L.V.H. The E.C.G. improvement was more striking in those with a recent onset of hypertension and a lower pretreatment heart rate. When control had been excellent or fair at 7.
Berglund, G., Sannerstedt, R., Anderson, O., Wedel, H., Wilhelmsen, L., Hansson, L., Silvertsson, R., Wikstrand, J. Lancet, 1978, i, 1.
1. Pickering, G. W., Cranston, W. I., Pears, M. A. The Treatment of Hypertension. Springfield, Illinois, 1961. 2. Kannel, W. B. Prog. cardiovasc. Dis. 1974, 17, 5. 3. Smirk, F. H.N.Z. med. J. 1964, 63, 413. 4. Sokolow, M., Werdegar, D., Kain, H. K., Hinman, A. T. Circulation, 1966, on
Antihypertensive
8. Carter, W. A., Estes, E. H. Am. Heart J. 1964, 68, 173. 9. Cosby, R. S., Herman, L. M. ibid. 1961, 63, 180. 10. Kannel, W. B., Gordon, T., Offutt, D. Ann. intern. Med. 1969, 71, 89. 11. George, C. F., Breckenridge, A. M., Dollery, C. T. Br. Heart J. 1972, 34, 618. 12. Poblete, P. F., Kyle, M. C., Pipberger, H. V. Circulation, 1973, 48, 481. 13. Littler, W. A., Honour, A. J., Pageley, D. J., Sleight, P. Postgrad. med. J.
on
Antihypertensive
14.
34, 279. 5. Veterans Administration
Cooperative Study Group Agents. J.Am. med. Ass. 1967, 202, 1028. 6. Veterans Administration Cooperative Study Group Agents, ibid. 1970, 213, 1143.
1976, 52, suppl. 7, p. 119. Ibrahim, M. M., Teraji, R. C., Dustan, H. P., Gifford, R. Med. 1977, 137, 1125.
W. Archs intern.
