1499
Reports, says the FDA should reopen its investigation of human food safety and stop the sale of milk from the experimental herd. A new report on BST commissioned by the institute says the "major human health concern is whether BST injections will lead to increased health problems in cattle, with consequent increased use of antibiotics". The author of the report, Michael Hansen, a biologist, wrote: "Widespread antibiotics use in foodConsumer
animals is of concern because it leads both to antibiotic residues in milk and to the development of antibiotic resistance in bacteria that can infect cows and
producing
more
people". Some scientists believe, on the basis of leaked documents, that the FDA is withholding adverse findings. They want the agency to make public all human and animal safety data used to justify its decision on BST. J. B. Sibbison
Conference Bioscience and society Dahlem, a suberb of west Berlin, has associations with Aldous Huxley’s Brave New World and with the "scientific" investigation of victims of Auschwitz. Since the war it has given its name more respectably to a series of multidisciplinary conferences on topics ranging from carbon dioxide emissions to bioethics. From Nov 26 to Nov 30 a 40-strong very mixed bag of scientists, environmentalists, ethicists, journalists, and clinicians met in Berlin in a Dahlem style workshop sponsored by Schering as part of its centenary celebrations. Bioscience Society covered just about everything that a not-so-brave world of the 21st century threatens us with, from ecological disaster to population collapse. Of the four workshop groups one was largely medical in its subject matter. Working from pre-circulated background papers, this group chose to tackle genetic counselling, the unravelling of the human genome, research on human embryos, and clinical uses of fetal tissue-and then, thinking that its self-inflicted remit was too oriented to "high tech" western medicine, the group added on the "demographic trap" controversy. In 1971 a 12-base bacteriophage DNA sequence took eight person-years to sort out: today laboratories can sequence 1000 base-pairs per person-day. Even so, the complete map of the genome is a long way off, for there is so much more to human DNA than its 4500 or so genes. The grand-sounding, even daunting Human Genome Project-HUGO, Big Brother is Watching You! was one of the background papers-is likely to yield details of only a few small chromosomes to start with, no 21 being a likely candidate. Those who dismiss fears that genetic knowledge would be abused forget that it was under a democracy that the Nazi genetic horrors of the 1930s were perpetrated and legitimised. Prof M. E. Pembrey, speaking from clinical experience and discussions with parents, argued convincingly that well-informed families make sensible choices without interference from the state. How nice it would be if the dissemination of genetic information could stay within the family. Some in the group thought that it should, but it is easy to envisage situations (some already with us) where further sharing would be tempting-screening before employment, health and life insurance, and the courts, for example. After all, phenotypic information is widely recorded, so why not the genotypic? Because of the detailed interpretation that must accompany it, was Pembrey’s reply; in some common gene disorders the other side of the genotypic coin, the as-yet-unknown population advantage, would have to be taken into account. Consensus was not an objective of the discussions, but the group did
agree that information
genetic risks was not enough. Society "a provide range of reproductive options from contraception, to selective termination of pregnancy, to support for families in caring for a handicapped child, regardless of the health-care system in place". As Prof E.-O. Backlund noted, the debate on fetal tissue could not be separated from the debate on abortion. The concerns were not just ethical but also scientific-for example, could potent fetal cells lead to problems of uncontrolled growth in the novel environment of the adult brain? Perhaps there were more hopeful prospects in techniques such as adrenal grafts with nerve growth factor or cell lines accompanied by gene manipulation. Fetal tissue grafts in Parkinson’s disease and diabetes were not living up to their early promise, ethical worries apart. In parts of the European Community there is a concern that couples are not having enough babies. That is not the focus of the demographic trap. In discussing Maurice King’s paper (Lancet, Sept 15) the group had a cultural hurdle to surmount. Even to put such an item on the agenda was seen by some to be tantamount to agreement with the case for depriving sick children of care. Previously the group had had some difficulty with "human integrity", the general topic it had been asked to explore, but here there was no doubt. In rejecting the planned withholding of health care from children the group was "as concerned about the survival of human integrity as it was about the survival of mankind". Birth control had to be pushed back to the top of the list of priorities in international aid for developing countries, and that meant the reversal, via public opinion, of the neglect and opposition that currently prevailed in some influential governments and churches. must
also try
on
to
The papers and summaries of the discussions will be published by Wiley in 1991, as Bioscience ± Society, edited by D. J. Roy, R. W. Old, and B. E. Wynne.
Medicine and the Law No-fault compensation Last week, the Chief Medical Officer at the Department of Health, Sir Donald Acheson, warned that the rising tide of litigation would make doctors reluctant to go into specialties such as obstetrics where litigation is most common. In the USA the litigation climate has already led to many doctors giving up obstetrics for fear of mammoth malpractice suits. A Royal College of Physicians’ working-party report, published on Dec 10/ recommends "a no-fault scheme, limited to compensating the adverse consequences of medical intervention". Such a scheme would impose ceilings on prospective loss of earnings on losses through pain and suffering. Claimants under the scheme would be disqualified from suing in the courts for the same injury. The working-party acknowledged that inequities would remain with a scheme limited to medical interventions but a comprehensive disability income scheme for all illness and injury related disability, irrespective of causation, did not seem a realistic option at present. The working-party stresses the need for accountability. One major criticism of no-fault schemes had been the removal of medical accountability. The report therefore recommends "a separate mechanism for the scrutiny of each claim in which doctors were involved to ensure that appropriate care had not been transgressed. If transgression is demonstrated, questions of professional discipline should be pursued". The working-party favours the strengthening of medical audit and peer review. Furthermore, a national database on cases involving adverse consequences of medical intervention should be made available for monitoring and for scientific analysis. District health authorities should coordinate their approaches to this problem, with the defence organisations (which do not now make their information available to outsiders) or through the Department of Health. In
October, 1988, at the annual Bar Conferencez and in October,
1500
1990, at the Law Society’s annual conference no-fault compensation for medical injuries was put to lawyers as a better alternative to lawsuits founded in claims for negligence. Lord Griffiths told Law Society delegates that medical negligence litigation "produces defensive medical techniques, it harms the doctor patient relationship and it produces trauma for both doctor and patient." He felt that litigants would be prepared to accept a reduction in damages if no-fault compensation could be introduced. Even if Britain were to adhere to the fault-based system the procedure needed review, he thought. "Medical negligence issues are very suitable for paper arbitration". The working-party takes a similar view: "a limited no-fault scheme ... would be a means by which reasonable levels of compensation could be provided promptly to the victims of medical intervention at relatively low administrative cost and with relative accessibility for those involved". The report’s recommendations are also consistent with those of the British Medical Association for a medical injury compensation scheme along Swedish lines. Last week Rosie Barnes MP drew third in the ballot for private members’ Bills. She has adopted Harriet Harman’s Medical Compensation Injury Bill. The NHS Compensation Bill has all-party sponsorship. The Harman Bill would be modified to provide compensation for adverse reactions to drugs prescribed under the National Health Service. The Bill as drafted is restricted to NHS treatment, while the Swedish and Finnish systems cover injuries related to private or to state medical care. A separate scheme for drug injuries per se (ie, those not caused by inappropriate prescribing) operates in these countries and injuries are funded by contributions from the pharmaceutical industry in Denmark and Norway. The Bill will provide for accountability. Mrs Barnes and her supporters hope to remove the development risks defence from the Consumer Protection Act 1987 (a defence already under challenge in the European Court as being unduly favourable to the manufacturer and not in accord with an EC directive). The aim of the Bill is to ensure that compensation for medical injuries which might reasonably have been avoided can be awarded promptly, fairly, without recourse to the courts and proof of negligence, and at a reasonable cost to the public purse. The NHS, as supplier of any drug which causes an adverse reaction which is compensatable, may choose to seek reimbursement from the manufacturer. It remains to be seen how the pharmaceutical industry and the Government respond; heavy industry lobbying during the passage of the Consumer Protection Act ensured that strict liability was heavily diluted, and in the Thatcher era the Government showed little enthusiasm for a no-fault scheme. The draft Bill excludes minor injuries. The Compensation for Medical Injury Scheme relates to injuries suffered during medical care (or any other aspect of it, including diet or transport or defects in equipment or materials) which causes death or necessitates inpatient treatment for 10 days or more or prevents the person engaging in his normal activities for 28 days or more and/or reduces life expectancy. Criteria for "medical mishap" exclude, for example, injury resulting partly or wholly from the underlying condition, unavoidable/reasonable error having regard to the state of medical knowledge and practice, unavoidable complication of a required procedure properly performed, and the use of a drug or other medication in accordance with the manufacturer’s instructions. The drug exception is under review since both Mrs Barnes and Dr David Owen (a sponsor, whose mother was an ’Opren’ victim) wish the scheme to cover injuries to contaminated factor VIII (or other blood products) or to drugs. The Medical Injury Compensation Board proposed in the Bill would have a legally qualified chairman and eight others, consisting of two lawyers, three doctors, and three laypersons. Each regional health authority would establish a compensation for medical injury office supervised by senior administrator (the compensation officer) and he or the board would have the discretion to award damages for pain and suffering and loss of earnings, in the form of a capital payment, periodic payments or a combination of both. The draft Bill does not preclude a person from bringing a tort action for any shortfall in damages. It remains to be seen whether, in its final form, the Barnes Bill will require claimant to elect one way or the other as recommended by the working-party’s report.’
Mrs Barnes and her Bill’s sponsors and other supporters of reform should heed Machiavelli’s warning that "a reformer has enemies in all those who profit by the old order, and only luke warm defenders in all those who would profit by the new". On Oct 30, 1990, in the US, a broad-based coalition of Maryland insurance, business, and civic organisations proposed lowering motor insurance rates by offering an optional no-frills, no-fault policy.4 Mr John Schochnor, president of the 1500 member Maryland Trial Lawyers Association, branded the proposal as "dumb" and the coalition as the propaganda machine of the insurance industry. Mr Gerard E. Evans, counsel to the Medical Chirurgical Faculty of Maryland, the state’s principal medical association with 8000 members, opposed the proposals because it limited doctors’ fees in no-fault accident cases to worker’s compensation levels. Diana Brahams 1.
Working Party on Compensation for Adverse Consequences of Medical Intervention, report. London. Royal College of Physicians of London,
1990. 2. Brahams D. Barristers debate medicolegal issues. Lancet 1988; i: 858 and 978. 3. Brahams D. The Swedish medical insurance schemes: the way ahead for the United Kingdom? Lancet 1988; i: 43-47; and No fault compensation Finnish style. Lancet 1988; ii: 733-36. 4. Valentine P. Maryland group seeks no-fault auto insurance trial lawyers, doctors oppose option Washington Post. Oct 31, 1990.
Noticeboard A year of
change at the MRC
The Medical Research Council annual report for 1989/90,1 published this week, looks decidedly more interesting than its predecessors. To give readers a feel for the wide range of work supported by the council, a few of the MRC’s senior scientists have been asked to review the progress of their chosen areas of research. Prof John Evans scans the human genetics scene from Cardiff (Huntington’s disease) via Oxford (Duchenne muscular dystrophy; synthesis of recombinant factor IX) to Edinburgh (embryological studies of the protein product of the Wilms’ tumour gene). Prof Colin Hopkins rounds off his review of cell biology and disease with a warning that within ten years all clinical and biochemical research workers will need a sound knowledge of molecular biological techniques. Readers who feel that much modem medical research is way beyond their grasp can escape into the comfort of past achievements in Prof C. N. Hales’ account of the MRC’s research on diabetes, beginning with its first account of the use of insulin in the 1922/23 report. The MRC has put much effort into research on autism, the subject of the final review. In Dr Uta Frith’s assessment, autism is now better understood than any other form of mental
handicap. The new format cannot conceal some less welcome changes at the MRC over the past year-namely, the closure of a number of units (three announced recently2 are to be added to those listed). A careful search through the report will also reveal the target date for the disbanding and dispersal of the Clinical Research Centre, part of the MRC’s grand new "clinical research initiative". The council’s "scaled down" plans for the Hammersmith site and its proposals for reinvesting "freed resources" (freed from where?) will do nothing to allay staff anxieties. Another change noted is the recent retirement of Lord Jellicoe, MRC chairman for the past eight years. His successor is Sir David Plastow. 1. Medical Research Council annual report 1989/90 Available from MRC Headquarters Office, 20 Park Crescent, London WIN 4AL, UK £8. 2. Anonymous MRC units to close Lancet 1990, 336: 500.
Reports, says the FDA should reopen its investigation of human food safety and stop the sale of milk from the experimental herd. A new report on BST commissioned by the institute says the "major human health concern is whether BST injections will lead to increased health problems in cattle, with consequent increased use of antibiotics". The author of the report, Michael Hansen, a biologist, wrote: "Widespread antibiotics use in foodConsumer
animals is of concern because it leads both to antibiotic residues in milk and to the development of antibiotic resistance in bacteria that can infect cows and
producing
more
people". Some scientists believe, on the basis of leaked documents, that the FDA is withholding adverse findings. They want the agency to make public all human and animal safety data used to justify its decision on BST. J. B. Sibbison
Conference Bioscience and society Dahlem, a suberb of west Berlin, has associations with Aldous Huxley’s Brave New World and with the "scientific" investigation of victims of Auschwitz. Since the war it has given its name more respectably to a series of multidisciplinary conferences on topics ranging from carbon dioxide emissions to bioethics. From Nov 26 to Nov 30 a 40-strong very mixed bag of scientists, environmentalists, ethicists, journalists, and clinicians met in Berlin in a Dahlem style workshop sponsored by Schering as part of its centenary celebrations. Bioscience Society covered just about everything that a not-so-brave world of the 21st century threatens us with, from ecological disaster to population collapse. Of the four workshop groups one was largely medical in its subject matter. Working from pre-circulated background papers, this group chose to tackle genetic counselling, the unravelling of the human genome, research on human embryos, and clinical uses of fetal tissue-and then, thinking that its self-inflicted remit was too oriented to "high tech" western medicine, the group added on the "demographic trap" controversy. In 1971 a 12-base bacteriophage DNA sequence took eight person-years to sort out: today laboratories can sequence 1000 base-pairs per person-day. Even so, the complete map of the genome is a long way off, for there is so much more to human DNA than its 4500 or so genes. The grand-sounding, even daunting Human Genome Project-HUGO, Big Brother is Watching You! was one of the background papers-is likely to yield details of only a few small chromosomes to start with, no 21 being a likely candidate. Those who dismiss fears that genetic knowledge would be abused forget that it was under a democracy that the Nazi genetic horrors of the 1930s were perpetrated and legitimised. Prof M. E. Pembrey, speaking from clinical experience and discussions with parents, argued convincingly that well-informed families make sensible choices without interference from the state. How nice it would be if the dissemination of genetic information could stay within the family. Some in the group thought that it should, but it is easy to envisage situations (some already with us) where further sharing would be tempting-screening before employment, health and life insurance, and the courts, for example. After all, phenotypic information is widely recorded, so why not the genotypic? Because of the detailed interpretation that must accompany it, was Pembrey’s reply; in some common gene disorders the other side of the genotypic coin, the as-yet-unknown population advantage, would have to be taken into account. Consensus was not an objective of the discussions, but the group did
agree that information
genetic risks was not enough. Society "a provide range of reproductive options from contraception, to selective termination of pregnancy, to support for families in caring for a handicapped child, regardless of the health-care system in place". As Prof E.-O. Backlund noted, the debate on fetal tissue could not be separated from the debate on abortion. The concerns were not just ethical but also scientific-for example, could potent fetal cells lead to problems of uncontrolled growth in the novel environment of the adult brain? Perhaps there were more hopeful prospects in techniques such as adrenal grafts with nerve growth factor or cell lines accompanied by gene manipulation. Fetal tissue grafts in Parkinson’s disease and diabetes were not living up to their early promise, ethical worries apart. In parts of the European Community there is a concern that couples are not having enough babies. That is not the focus of the demographic trap. In discussing Maurice King’s paper (Lancet, Sept 15) the group had a cultural hurdle to surmount. Even to put such an item on the agenda was seen by some to be tantamount to agreement with the case for depriving sick children of care. Previously the group had had some difficulty with "human integrity", the general topic it had been asked to explore, but here there was no doubt. In rejecting the planned withholding of health care from children the group was "as concerned about the survival of human integrity as it was about the survival of mankind". Birth control had to be pushed back to the top of the list of priorities in international aid for developing countries, and that meant the reversal, via public opinion, of the neglect and opposition that currently prevailed in some influential governments and churches. must
also try
on
to
The papers and summaries of the discussions will be published by Wiley in 1991, as Bioscience ± Society, edited by D. J. Roy, R. W. Old, and B. E. Wynne.
Medicine and the Law No-fault compensation Last week, the Chief Medical Officer at the Department of Health, Sir Donald Acheson, warned that the rising tide of litigation would make doctors reluctant to go into specialties such as obstetrics where litigation is most common. In the USA the litigation climate has already led to many doctors giving up obstetrics for fear of mammoth malpractice suits. A Royal College of Physicians’ working-party report, published on Dec 10/ recommends "a no-fault scheme, limited to compensating the adverse consequences of medical intervention". Such a scheme would impose ceilings on prospective loss of earnings on losses through pain and suffering. Claimants under the scheme would be disqualified from suing in the courts for the same injury. The working-party acknowledged that inequities would remain with a scheme limited to medical interventions but a comprehensive disability income scheme for all illness and injury related disability, irrespective of causation, did not seem a realistic option at present. The working-party stresses the need for accountability. One major criticism of no-fault schemes had been the removal of medical accountability. The report therefore recommends "a separate mechanism for the scrutiny of each claim in which doctors were involved to ensure that appropriate care had not been transgressed. If transgression is demonstrated, questions of professional discipline should be pursued". The working-party favours the strengthening of medical audit and peer review. Furthermore, a national database on cases involving adverse consequences of medical intervention should be made available for monitoring and for scientific analysis. District health authorities should coordinate their approaches to this problem, with the defence organisations (which do not now make their information available to outsiders) or through the Department of Health. In
October, 1988, at the annual Bar Conferencez and in October,
1500
1990, at the Law Society’s annual conference no-fault compensation for medical injuries was put to lawyers as a better alternative to lawsuits founded in claims for negligence. Lord Griffiths told Law Society delegates that medical negligence litigation "produces defensive medical techniques, it harms the doctor patient relationship and it produces trauma for both doctor and patient." He felt that litigants would be prepared to accept a reduction in damages if no-fault compensation could be introduced. Even if Britain were to adhere to the fault-based system the procedure needed review, he thought. "Medical negligence issues are very suitable for paper arbitration". The working-party takes a similar view: "a limited no-fault scheme ... would be a means by which reasonable levels of compensation could be provided promptly to the victims of medical intervention at relatively low administrative cost and with relative accessibility for those involved". The report’s recommendations are also consistent with those of the British Medical Association for a medical injury compensation scheme along Swedish lines. Last week Rosie Barnes MP drew third in the ballot for private members’ Bills. She has adopted Harriet Harman’s Medical Compensation Injury Bill. The NHS Compensation Bill has all-party sponsorship. The Harman Bill would be modified to provide compensation for adverse reactions to drugs prescribed under the National Health Service. The Bill as drafted is restricted to NHS treatment, while the Swedish and Finnish systems cover injuries related to private or to state medical care. A separate scheme for drug injuries per se (ie, those not caused by inappropriate prescribing) operates in these countries and injuries are funded by contributions from the pharmaceutical industry in Denmark and Norway. The Bill will provide for accountability. Mrs Barnes and her supporters hope to remove the development risks defence from the Consumer Protection Act 1987 (a defence already under challenge in the European Court as being unduly favourable to the manufacturer and not in accord with an EC directive). The aim of the Bill is to ensure that compensation for medical injuries which might reasonably have been avoided can be awarded promptly, fairly, without recourse to the courts and proof of negligence, and at a reasonable cost to the public purse. The NHS, as supplier of any drug which causes an adverse reaction which is compensatable, may choose to seek reimbursement from the manufacturer. It remains to be seen how the pharmaceutical industry and the Government respond; heavy industry lobbying during the passage of the Consumer Protection Act ensured that strict liability was heavily diluted, and in the Thatcher era the Government showed little enthusiasm for a no-fault scheme. The draft Bill excludes minor injuries. The Compensation for Medical Injury Scheme relates to injuries suffered during medical care (or any other aspect of it, including diet or transport or defects in equipment or materials) which causes death or necessitates inpatient treatment for 10 days or more or prevents the person engaging in his normal activities for 28 days or more and/or reduces life expectancy. Criteria for "medical mishap" exclude, for example, injury resulting partly or wholly from the underlying condition, unavoidable/reasonable error having regard to the state of medical knowledge and practice, unavoidable complication of a required procedure properly performed, and the use of a drug or other medication in accordance with the manufacturer’s instructions. The drug exception is under review since both Mrs Barnes and Dr David Owen (a sponsor, whose mother was an ’Opren’ victim) wish the scheme to cover injuries to contaminated factor VIII (or other blood products) or to drugs. The Medical Injury Compensation Board proposed in the Bill would have a legally qualified chairman and eight others, consisting of two lawyers, three doctors, and three laypersons. Each regional health authority would establish a compensation for medical injury office supervised by senior administrator (the compensation officer) and he or the board would have the discretion to award damages for pain and suffering and loss of earnings, in the form of a capital payment, periodic payments or a combination of both. The draft Bill does not preclude a person from bringing a tort action for any shortfall in damages. It remains to be seen whether, in its final form, the Barnes Bill will require claimant to elect one way or the other as recommended by the working-party’s report.’
Mrs Barnes and her Bill’s sponsors and other supporters of reform should heed Machiavelli’s warning that "a reformer has enemies in all those who profit by the old order, and only luke warm defenders in all those who would profit by the new". On Oct 30, 1990, in the US, a broad-based coalition of Maryland insurance, business, and civic organisations proposed lowering motor insurance rates by offering an optional no-frills, no-fault policy.4 Mr John Schochnor, president of the 1500 member Maryland Trial Lawyers Association, branded the proposal as "dumb" and the coalition as the propaganda machine of the insurance industry. Mr Gerard E. Evans, counsel to the Medical Chirurgical Faculty of Maryland, the state’s principal medical association with 8000 members, opposed the proposals because it limited doctors’ fees in no-fault accident cases to worker’s compensation levels. Diana Brahams 1.
Working Party on Compensation for Adverse Consequences of Medical Intervention, report. London. Royal College of Physicians of London,
1990. 2. Brahams D. Barristers debate medicolegal issues. Lancet 1988; i: 858 and 978. 3. Brahams D. The Swedish medical insurance schemes: the way ahead for the United Kingdom? Lancet 1988; i: 43-47; and No fault compensation Finnish style. Lancet 1988; ii: 733-36. 4. Valentine P. Maryland group seeks no-fault auto insurance trial lawyers, doctors oppose option Washington Post. Oct 31, 1990.
Noticeboard A year of
change at the MRC
The Medical Research Council annual report for 1989/90,1 published this week, looks decidedly more interesting than its predecessors. To give readers a feel for the wide range of work supported by the council, a few of the MRC’s senior scientists have been asked to review the progress of their chosen areas of research. Prof John Evans scans the human genetics scene from Cardiff (Huntington’s disease) via Oxford (Duchenne muscular dystrophy; synthesis of recombinant factor IX) to Edinburgh (embryological studies of the protein product of the Wilms’ tumour gene). Prof Colin Hopkins rounds off his review of cell biology and disease with a warning that within ten years all clinical and biochemical research workers will need a sound knowledge of molecular biological techniques. Readers who feel that much modem medical research is way beyond their grasp can escape into the comfort of past achievements in Prof C. N. Hales’ account of the MRC’s research on diabetes, beginning with its first account of the use of insulin in the 1922/23 report. The MRC has put much effort into research on autism, the subject of the final review. In Dr Uta Frith’s assessment, autism is now better understood than any other form of mental
handicap. The new format cannot conceal some less welcome changes at the MRC over the past year-namely, the closure of a number of units (three announced recently2 are to be added to those listed). A careful search through the report will also reveal the target date for the disbanding and dispersal of the Clinical Research Centre, part of the MRC’s grand new "clinical research initiative". The council’s "scaled down" plans for the Hammersmith site and its proposals for reinvesting "freed resources" (freed from where?) will do nothing to allay staff anxieties. Another change noted is the recent retirement of Lord Jellicoe, MRC chairman for the past eight years. His successor is Sir David Plastow. 1. Medical Research Council annual report 1989/90 Available from MRC Headquarters Office, 20 Park Crescent, London WIN 4AL, UK £8. 2. Anonymous MRC units to close Lancet 1990, 336: 500.
