120
Genetics, ethics, and audit SIR,—In response to my article in the issue of May 12 (p 1145), Dr Bundey (June 9, p 1406) voices her disagreement over the crucial question of how clinical genetics should justify its existence. Bundey would have us indicate the fall in birth incidence of handicapping disorders "achieved" by our activities. This is implicitly an appeal to cost-benefit analysis as the final arbiter of clinical worth. It lays us open to administrative pressure to maximise return on investment in our work, through increasing the rate of terminations of pregnancy for costly disorders. I prefer a different defence. We offer information and support to patients and families in need of explanation and compassion: this is
in itself an adequate end. We help people who are facing difficult decisions about reproduction. I would like the audit to assess how well we carry out these functions, not how much money we save. Much of my clinical workload has no immediate relevance to an established or a planned pregnancy: is it then a waste of time? I know that Bundey does not mean to imply any of this, but her views may lead others to such conclusions. I should add that monitoring of the birth incidence of congenital malformations and inherited disease is a perfectly respectable, in fact necessary, activity. I would be opposed to the use of such data as an audit of my work, not to the collection of the data for other purposes. The letter from Davis in the same issue articulates some deep-felt emotions. Like her, I am concerned that society may become less and less accepting of the handicapped, particularly if their problems are seen as preventable. The parents of handicapped children may then be censured for their irresponsibility in failing to screen their pregnancy or terminate the affected fetus. Clinical geneticists must take positive steps to clarify their position on such matters, and to argue for the proper provision of medical and social facilities for the handicapped. Our failure to do this will otherwise be misconstrued as support for modern "eugenics by accountancy", and can only contribute to the shoddy deal now offered to the disabled by society at
the misery inflicted upon the unfortunate woman, described in her article, by two full, defended, expensive trials. Special Hospitals Service Authority, 375 Kensington High Street,
J. TAYLOR
Litigation and criticisms about drugs SIR,-Klinge Pharma (June 16, p 1467) has a record of going to law against critics of its product ’Venostasin’ (horse-chestnut seed extract). In 1969 this company tried to prevent publication of a critical report in Tdgliche Praxis, but failed in court.! In 1989, the company threatened litigation against a group which had found no effect of venostasin on transcapillary filtration,2 to suppress this negative finding. Incidentally, the 22% reduction in transcapillary filtration rate cited by Mr Beck represents only a 0.23 % reduction in leg volume, a therapeutically insignificant effect.3 In 1990, Klinge threatened litigation against the authors of ArzneiverordnungsReport ’89, a review of prescription drug use, to force the editors to withdraw negative statements about the product’s efficacy.4 It also sued the publisher of Transparenz-Telegramm (1990/91),5 a guide on rational prescribing which included similar statements-even though standard textbooks on drug therapy describe this product as lacking substantial evidence of efficacy.6,7This case is still proceeding. When a manufacturer has failed to provide convincing evidence of efficacy for its product, attempts to silence scientific criticism through the courts are an abuse of the law. Unfortunately, authors often appear to yield to legal threats because of the financial implications. Institute of Clinical Pharmacology, ZKH St-Jurgen-Str, D-2800 Bremen, West Germany
PETER S. SCHÖNHÖFER
1 Editorial. Unsere Umfrage uber Roßkastanienpraparate. Tagl Praxis 1969; 10: 717. 2. Jansen W, Wienert V. Beeinflussung der kapillaren Filtration durch Aescin. Phlebol Proktol 1989; 18: 101. 3. Schonhofer PS. Roßkastaniensamenextrakt (Venostasin retard). Was bedeutet eine 22 %ige Hemmung der transkapillaren Filtration? KV Journal (Hamburg) 1990; 20: 18. 4. Schwabe U, Paffrath D. Arzneiverordnungs-Report ’89. Stuttgart: Fischer, 1989:10,
large.
Institute of Medical Genetics, University Hospital of Wales, Cardiff CF4 4XN, UK
PAMELA
London W14 8QH, UK
12, 408, 410. 5. Transparenz-Telegramm 1990/91. Berlin. A.V.I. Arzneimittel-Verlag, 1990: 504. 6. Arzneimittelkommission der Deutschen Ärzteschaft: Arzneiverordnungen. 16th ed. Köln: Deutscher Ärzte-Verlag, 1988: 345. 7. Fulgraff G, Palm D. Pharmakotherapie—Klinische Pharmakologie. 7th ed. Stuttgart. Fischer, 1989: 125.
ANGUS CLARKE
Insane automatism
Consensus conferences
SIR,-Mrs Brahams (June 2, p 1333) is mistaken when she writes that in the UK a successful defence of "insane automatism" automatically results in detention in a special hospital. In the decision about placement the court, unusually, directs the patient to a specific hospital, but not necessarily one that provides maximum security. Although the insanity defence is very rare it is possible to show that the courts have been substantially less likely to direct to a special hospital in these circumstances than to other NHS
psychiatric services (6 of 29 cases since 1980). Your medicolegal correspondent also fosters perpetuation of the concept of the "stigma of insanity". Insanity is not a medical diagnosis, but a legal term with a well-defined meaning. If there is a lay tendency to construe the legal term as anything but respectable, then the pressure should be to abandon its use for all, not just for those with epilepsy or post-traumatic stress disorder. The crucial point is that the problem faced by people who might successfully run the defence of insane automatism, and those who would provide for their care and safety, is but the tip of an outmoded legal iceberg of response-namely, the mandatory consequence of certain convictions or fmdings in court. People with psychotic illnesses, who might more understandably be found legally insane, and the unfit to plead are in the same position. In relation to a conviction for murder the judge finds himself in the same plight; he cannot exercise his discretion in the interests of the safest disposal of the convicted person. Pressure should be for the abolition of mandatory sentencing or disposal. This would not only serve the interests of the tiny group of people addressed by Diana Brahams, but also render the legal process generally more rational. In turn this might stem the grotesque misuse of public money of the kind which compounded
SIR,- It would be unfortunate if Lancet readers were to assume that all
consensus
conferences
are
open to Dr Skrabanek’s criticisms
(June 16, p 1446). Skrabanek correctly states that the need for consensus stems from lack of consensus. But he is wrong to infer that such a lack arises because consensus is unnecessary. The King’s Fund has now run seven major consensus conferences addressing clinical issues. In all of these we have sought, and obtained, a consensus from a panel about what clinical and other actions the data support. We have assembled a range of members (both medical and non-medical) who, although reputed for their ability to analyse data critically, are not established experts in the subject under discussion. Experts of course do have a role in our conferences-to present their data to the panel, with differing views being assessed only through the evaluation of those data. Furthermore, this assessment takes place at a
open meeting. Perhaps because of this approach the King’s Fund conference on blood cholesterol measurement in the prevention of coronary heart disease concluded that routine assessment of blood cholesterol, in the absence of other risk factors, was inappropriate. That this an
conclusion differed from that of another consensus conference demonstrates that not all panels behave as Skrabanek believes. Skrabanek is rightly critical of medical fashions and technologies that are not evaluated. Such evaluation and dissemination is important and complex, and we believe that properly conceived consensus conferences have much to contribute here. King’s Fund Centre for Health Services Development, London NW1 7NF, UK
DAVID COSTAIN
Genetics, ethics, and audit SIR,—In response to my article in the issue of May 12 (p 1145), Dr Bundey (June 9, p 1406) voices her disagreement over the crucial question of how clinical genetics should justify its existence. Bundey would have us indicate the fall in birth incidence of handicapping disorders "achieved" by our activities. This is implicitly an appeal to cost-benefit analysis as the final arbiter of clinical worth. It lays us open to administrative pressure to maximise return on investment in our work, through increasing the rate of terminations of pregnancy for costly disorders. I prefer a different defence. We offer information and support to patients and families in need of explanation and compassion: this is
in itself an adequate end. We help people who are facing difficult decisions about reproduction. I would like the audit to assess how well we carry out these functions, not how much money we save. Much of my clinical workload has no immediate relevance to an established or a planned pregnancy: is it then a waste of time? I know that Bundey does not mean to imply any of this, but her views may lead others to such conclusions. I should add that monitoring of the birth incidence of congenital malformations and inherited disease is a perfectly respectable, in fact necessary, activity. I would be opposed to the use of such data as an audit of my work, not to the collection of the data for other purposes. The letter from Davis in the same issue articulates some deep-felt emotions. Like her, I am concerned that society may become less and less accepting of the handicapped, particularly if their problems are seen as preventable. The parents of handicapped children may then be censured for their irresponsibility in failing to screen their pregnancy or terminate the affected fetus. Clinical geneticists must take positive steps to clarify their position on such matters, and to argue for the proper provision of medical and social facilities for the handicapped. Our failure to do this will otherwise be misconstrued as support for modern "eugenics by accountancy", and can only contribute to the shoddy deal now offered to the disabled by society at
the misery inflicted upon the unfortunate woman, described in her article, by two full, defended, expensive trials. Special Hospitals Service Authority, 375 Kensington High Street,
J. TAYLOR
Litigation and criticisms about drugs SIR,-Klinge Pharma (June 16, p 1467) has a record of going to law against critics of its product ’Venostasin’ (horse-chestnut seed extract). In 1969 this company tried to prevent publication of a critical report in Tdgliche Praxis, but failed in court.! In 1989, the company threatened litigation against a group which had found no effect of venostasin on transcapillary filtration,2 to suppress this negative finding. Incidentally, the 22% reduction in transcapillary filtration rate cited by Mr Beck represents only a 0.23 % reduction in leg volume, a therapeutically insignificant effect.3 In 1990, Klinge threatened litigation against the authors of ArzneiverordnungsReport ’89, a review of prescription drug use, to force the editors to withdraw negative statements about the product’s efficacy.4 It also sued the publisher of Transparenz-Telegramm (1990/91),5 a guide on rational prescribing which included similar statements-even though standard textbooks on drug therapy describe this product as lacking substantial evidence of efficacy.6,7This case is still proceeding. When a manufacturer has failed to provide convincing evidence of efficacy for its product, attempts to silence scientific criticism through the courts are an abuse of the law. Unfortunately, authors often appear to yield to legal threats because of the financial implications. Institute of Clinical Pharmacology, ZKH St-Jurgen-Str, D-2800 Bremen, West Germany
PETER S. SCHÖNHÖFER
1 Editorial. Unsere Umfrage uber Roßkastanienpraparate. Tagl Praxis 1969; 10: 717. 2. Jansen W, Wienert V. Beeinflussung der kapillaren Filtration durch Aescin. Phlebol Proktol 1989; 18: 101. 3. Schonhofer PS. Roßkastaniensamenextrakt (Venostasin retard). Was bedeutet eine 22 %ige Hemmung der transkapillaren Filtration? KV Journal (Hamburg) 1990; 20: 18. 4. Schwabe U, Paffrath D. Arzneiverordnungs-Report ’89. Stuttgart: Fischer, 1989:10,
large.
Institute of Medical Genetics, University Hospital of Wales, Cardiff CF4 4XN, UK
PAMELA
London W14 8QH, UK
12, 408, 410. 5. Transparenz-Telegramm 1990/91. Berlin. A.V.I. Arzneimittel-Verlag, 1990: 504. 6. Arzneimittelkommission der Deutschen Ärzteschaft: Arzneiverordnungen. 16th ed. Köln: Deutscher Ärzte-Verlag, 1988: 345. 7. Fulgraff G, Palm D. Pharmakotherapie—Klinische Pharmakologie. 7th ed. Stuttgart. Fischer, 1989: 125.
ANGUS CLARKE
Insane automatism
Consensus conferences
SIR,-Mrs Brahams (June 2, p 1333) is mistaken when she writes that in the UK a successful defence of "insane automatism" automatically results in detention in a special hospital. In the decision about placement the court, unusually, directs the patient to a specific hospital, but not necessarily one that provides maximum security. Although the insanity defence is very rare it is possible to show that the courts have been substantially less likely to direct to a special hospital in these circumstances than to other NHS
psychiatric services (6 of 29 cases since 1980). Your medicolegal correspondent also fosters perpetuation of the concept of the "stigma of insanity". Insanity is not a medical diagnosis, but a legal term with a well-defined meaning. If there is a lay tendency to construe the legal term as anything but respectable, then the pressure should be to abandon its use for all, not just for those with epilepsy or post-traumatic stress disorder. The crucial point is that the problem faced by people who might successfully run the defence of insane automatism, and those who would provide for their care and safety, is but the tip of an outmoded legal iceberg of response-namely, the mandatory consequence of certain convictions or fmdings in court. People with psychotic illnesses, who might more understandably be found legally insane, and the unfit to plead are in the same position. In relation to a conviction for murder the judge finds himself in the same plight; he cannot exercise his discretion in the interests of the safest disposal of the convicted person. Pressure should be for the abolition of mandatory sentencing or disposal. This would not only serve the interests of the tiny group of people addressed by Diana Brahams, but also render the legal process generally more rational. In turn this might stem the grotesque misuse of public money of the kind which compounded
SIR,- It would be unfortunate if Lancet readers were to assume that all
consensus
conferences
are
open to Dr Skrabanek’s criticisms
(June 16, p 1446). Skrabanek correctly states that the need for consensus stems from lack of consensus. But he is wrong to infer that such a lack arises because consensus is unnecessary. The King’s Fund has now run seven major consensus conferences addressing clinical issues. In all of these we have sought, and obtained, a consensus from a panel about what clinical and other actions the data support. We have assembled a range of members (both medical and non-medical) who, although reputed for their ability to analyse data critically, are not established experts in the subject under discussion. Experts of course do have a role in our conferences-to present their data to the panel, with differing views being assessed only through the evaluation of those data. Furthermore, this assessment takes place at a
open meeting. Perhaps because of this approach the King’s Fund conference on blood cholesterol measurement in the prevention of coronary heart disease concluded that routine assessment of blood cholesterol, in the absence of other risk factors, was inappropriate. That this an
conclusion differed from that of another consensus conference demonstrates that not all panels behave as Skrabanek believes. Skrabanek is rightly critical of medical fashions and technologies that are not evaluated. Such evaluation and dissemination is important and complex, and we believe that properly conceived consensus conferences have much to contribute here. King’s Fund Centre for Health Services Development, London NW1 7NF, UK
DAVID COSTAIN
