237
journalistic subterfuge, the story does underline the value of the EC’s guidelines for Good Clinical Practice, which would make it mandatory (as in Germany) for physicians to consult their regional ethics committees before agreeing to take part in any trial in human beings. Karl H. Kimbel
relevant time. Pain caused by movements in posture at work was acknowledged in the 19th century as "traumatic tenosynovitis" and "peritendinitis crepitans". Early this century these conditions were recognised among morse code operators, for example, and in 1948 "traumatic inflammation of the hand or forearm or of the associated tendon sheaths" was listed as a prescribed disease in the UK under the National Insurance Regulations. In 1958, so
Japanese punchcard perforators, typists, and keyboard operators had cervicobrachial disorders that the government introduced a work maximum of 5 hours per day and no more than 40 000 key strokes. However, this condition did not find its way into Hunter’s book Diseases of Occupations until 1987 though, in 1969, Hunter had recorded traumatic tenosynovitis among typists and comptometer workers. In the UK some people thought that the lightness of touch of new electrical keyboards would reduce RSI-indeed concerns about this emerging technology tended to focus on the dangers associated with the visual display itself. However, by 1981, RSI had emerged as a problem within the British Civil Service (notably the Worthing office of the Inland Revenue). An inquiry acepted that complaints, including tennis elbow and true tenosynovitis were work-related disorders. In 1980 a key conference on the ergonomic aspects of VDUs many
Medicine and the Law Keyboard operators’ repetitive strain injury On Dec 16, 1991, Judge Byrt in the High Court found that two British Telecom (BT) keyboard operators working with visual display units (VDU) had tenosynovitis in their legs, arms, and shoulders due to the negligence of their employer. The repetitive strain injury (RSI) had been induced by a combination of the nature of the work (at least 10 000 keyboard depressions an hour, with a bonus payment for higher totals), long hours seated on unsuitable and often defective chairs, and fixed screens on desks with modesty panels which did not allow the operator to stretch her legs forward. The judge awarded the two women c6000 damages each plus costs (estimated at about k 100 000). BT is likely to appeal. One plaintiff had worked for BT in Cardiff from 1979, keying with her middle fingers only at 11 500 per hour until RSI began to hamper her performance. In late 1983 pain started in her thumbs and though she continued working the condition of her hands deteriorated. Her thumbs began to curl across her palms causing severe pain. The pain moved into her wrists, arms, and then shoulders and neck. In September, 1984, she read a trade union circular about tenosynovitis and she went to see her general practitioner, who diagnosed tenosynovitis ("tennis elbow"). She did not return to work until Nov 16, when, at her request, she was transferred to clerical duties. It was accepted that her condition fell within the category of RSI or work-related upper-limb disorder. However, the medical witnesses disagreed about the significance of certain causative elements of RSI. The plaintiffs and the defendant’s consultants agreed that pressures, subjectively experienced by the individual as a response to her work or home environment, her posture, and the ergonomics of her workstation, all made the operator more vulnerable to RSI. If through her ignorance of the risks an operator soldiered on, the condition might become chronic. The engineers would not remove the modesty panels for fear of destabilising the desks and damaging wires and conduits. The plaintiff had opened a drawer and put her feet on it to give her legs more room, and most of the operators did something like that. All the operators called as witnesses said that they were given no training or warning that posture was important. It was alleged by the plaintiffs that BT failed to provide suitable adjustable chairs and footrests. "Management’s laissez-faire attitude towards bad posture" would, the judge said, have done nothing to alert operators about the dangers. The plaintiff had sometimes had to work on a chair which could not be adjusted properly, and this would have increased the risk of musculoskeletal injury. The judge made similar findings of causation for the RSIin the second plaintiff, who had worked for BT in Swindon. Posture and defective office furniture apart, the cases before Judge Byrt focused on what BT knew or might reasonably be expected to have known about RSI at the
concluded that the constrained postures at VDUs can a small proportion of operators, injuries in muscle and tendons. In 1982, BT provided guidance on VDUs which noted that "special attention has to be given to those parts of the musculoskeletal system of the body which are likely to remain comparatively static". Unfortunately, the BT guidelines expressly excluded their application where VDUs were used on a "full-scale dedicated basis" -which is exactly the kind of unit where the two plaintiffs worked. Nevertheless, the judge was not satisfied that BT knew enough about the causal connection between RSI and keyboard work to warrant radical action in time to have spared the plaintiffs injury. Between 1980 and 1984, there had been "a gap in the literature". The issue of the Australian Health and Safety Bulletin of August, 1982, had only been received in the UK in January, 1985. It would not in any event have been sufficient to "fix BT with constructive knowledge", a lawyer’s way of saying "BT should have known". Even when BT’s medical team had convinced itself of the connection between RSI and keyboard work the remedy would have lain in a reconsideration of flexitime rules, proficiency allowances, or the monitoring procedures, and would have required workforce cooperation. On the other hand the judge was satisfied that BT knew or ought to have known that postures of the sort adopted by these operators were likely to cause serious musculoskeletal injury. BT was responsible for ensuring that bad postures were corrected. The problem was the posture, not the injury, and the workforce was engaged in a task which the occupational medicine team should have known was potentially stressful. Those doctors should have advised that managers must be fully informed that staff would be vulnerable to injury unless their posture conformed to well-defined guidelines. Had the 1982 instruction been circulated more widely the plaintiffs might have escaped the worst effects of RSI. The combination of intensive, repetitive keyboard work and poor posture was responsible, and poor posture was a substantial contributor. The judge also found that BT’s failure to provide suitable chairs
produce, in
238
amounted to a breach of their statutory duty. However, BT’s failure to warn of the risk that keyboard work might cause RSI to new recruits or to encourage workers to report any aches and pains at onset did not amount to a breach of
statutory duty. Diana Brahams
Conference AIDS in Africa 1 in 40 African adults is now infected with HIV. These 6 million women and men, and the three-quarters of a million infected children, are unevenly distributed over the continent. In East Africa the real burden of disease and death is only just beginning to be felt, but already AIDS cases make up to 80% of the case-load in some adult hospital wards. Practically everywhere the number of people with asymptomatic HIV infections is multiplying rapidly. 1 in 8 adults in Abidjan now carry HIV 1 or HIV 2. The burden of associated diseases is overwhelming: 40% of patients dying from AIDS have cerebral lesions, most commonly toxoplasmosis and tuberculosis. Already there are 50 000 AIDS orphans in just one region (Kagera) in Tanzania, and agricultural production in the same area has fallen by 3-20%. Yet only a small fraction of those infected with HIV in any part of Africa have died. From the point of view of cost to the community and health services the epidemic is
only just beginning. The Sixth International Conference
on
graciously opened by the President of Senegal, Monsieur Aboon Diouf, and even President Bush sent a message. Finally, such conferences disseminate information to the rest of the world. For example, studies in Nairobi suggest that the use of oral contraceptives and intrauterine devices is associated with any increased or reduced risk of seroconversion, and data from Cameroon give some preliminary evidence of a protective effect of spermicide use on the acquisition of HIV. More evidence is accumulating about the long incubation period of HIV-2. But despite much of interest, many of the outcomes of the meeting might have been achieved more cost-effectively. Perhaps the several, much smaller, satellite meetings by WHO/GPA, Family Health International, and Bristol Myers Squibb held in Dakar are a more appropriate model for the future. Certainly another world conference in Amsterdam in the middle of 1992 and a Seventh AIDS in Africa conference in Yaounde at the end of next year seems a bit like conference overload. One participant, who has known AIDS for longer and more closely than most, saw the Dakar meeting "as a rerun of the first AIDS in Africa conference in Brussels in 1985 but with the decimal point moved". In other words, HIV prevalences continue to rise and even experts do not always learn quickly enough.
not
International First Floor,
Family Health,
Margaret Pyke Centre, 15 Bateman’s Buildings, London W1V 5TW
Malcolm Potts
AIDS in Africa
(Dec 16-18, 1991) brought 1800 participants from 79 countries to Dakar, Senegal. Many conference presentations measured the spread of HIV or threw light on the
knowledge and attitudes of vulnerable groups such as prostitutes and their clients. Less than 10% of commercial sex workers in one Cameroon sample used condoms regularly and 60% of long-distance lorry drivers in Zimbabwe have sex with a prostitute at least once a month. Somewhat fewer papers dealt with preventive measures such as education, distribution of condoms, or treatment of other sexually transmitted diseases (STD). The poverty of the Sahel, political unrest in Zaire, debt burdens in Nigeria, and the legacy of previous bad government in Uganda are all factors mitigating against disease control. So is the low status of women. In many parts of Africa women handle much of the subsistence farming and petty commerce but receive the least reward. Even so, there have been successes in HIV prevention: prostitutes in Ghana have changed their behaviour, the social marketing of condoms in Zaire has been most successful, and the comprehensive control of STDs through government services has been initiated in Tanzania. The challenge is to develop the will and mobilise the resources (national and international) to turn pilot projects into epidemiologically significant programmes. At present, however, it is difficult to escape the conclusion that HIV is out of control. Among other things, it must also be asked whether large, expensive conferences are themselves an appropriate response? Conferences help forge needed partnerships between developing and developed countries and are certainly essential for recharging the skills and motivation for those fighting in the trenches in the battle against AIDS. Scientists from Belgium, France, and the USA played an important part in the Dakar meeting. Conferences also allow national leaders to express support: the sixth conference was
Noticeboard Safeguards for gene therapy Somatic gene
therapy
will be allowed in the UK if the
recommendations of the Committee on the Ethics of Gene Therapy are accepted by the Government. But the Department of Health will be seeking the views of many professional and lay organisations before the Government reaches its decision. The consultation period will end on May 18. Any proposed gene therapy must be ethically acceptable and shown to be safe, says the committee’s report, published last week.’ The committee, a non-statutory body set up by UK health ministers in 1989 under the chairmanship of Sir Cecil Clothier, QC, says that gene therapy raises no new ethical issues, but because the treatment is new it recommends that gene therapy should be subject to the ethical codes that apply to research involving patients. Familiar ethical considerations that are likely to assume greater prominence when gene therapy is being considered include safety (because of the possibility of unpredicted consequences of gene insertion), the need for long-term surveillance, consent (especially regarding uncertainties about outcome), the probability that children will be among the first candidates for gene therapy, and
confidentiality. Gene therapy, the committee recommends, should be restricted to the alleviation of disease in individual patients and should not be used to change normal human traits. The first candidates for gene therapy should be patients with a lifethreatening or seriously disabling genetic disease. Severe genetic disorders that show their effects in early childhood, or even before birth, should be treated correspondingly early. Germline gene therapy should not be attempted at present, says the report, because "there is insufficient knowledge to evaluate the risk to future generations". At a meeting of the Human Genome Organisation in London last August Dame Mary Warnock, chairman of the 1984 committee that approved in-vitro fertilisation and limited research on human embryos, said that unpredictable outcome was a more valid reason for rejecting germline therapy than was
fear of doctors’ powers.
journalistic subterfuge, the story does underline the value of the EC’s guidelines for Good Clinical Practice, which would make it mandatory (as in Germany) for physicians to consult their regional ethics committees before agreeing to take part in any trial in human beings. Karl H. Kimbel
relevant time. Pain caused by movements in posture at work was acknowledged in the 19th century as "traumatic tenosynovitis" and "peritendinitis crepitans". Early this century these conditions were recognised among morse code operators, for example, and in 1948 "traumatic inflammation of the hand or forearm or of the associated tendon sheaths" was listed as a prescribed disease in the UK under the National Insurance Regulations. In 1958, so
Japanese punchcard perforators, typists, and keyboard operators had cervicobrachial disorders that the government introduced a work maximum of 5 hours per day and no more than 40 000 key strokes. However, this condition did not find its way into Hunter’s book Diseases of Occupations until 1987 though, in 1969, Hunter had recorded traumatic tenosynovitis among typists and comptometer workers. In the UK some people thought that the lightness of touch of new electrical keyboards would reduce RSI-indeed concerns about this emerging technology tended to focus on the dangers associated with the visual display itself. However, by 1981, RSI had emerged as a problem within the British Civil Service (notably the Worthing office of the Inland Revenue). An inquiry acepted that complaints, including tennis elbow and true tenosynovitis were work-related disorders. In 1980 a key conference on the ergonomic aspects of VDUs many
Medicine and the Law Keyboard operators’ repetitive strain injury On Dec 16, 1991, Judge Byrt in the High Court found that two British Telecom (BT) keyboard operators working with visual display units (VDU) had tenosynovitis in their legs, arms, and shoulders due to the negligence of their employer. The repetitive strain injury (RSI) had been induced by a combination of the nature of the work (at least 10 000 keyboard depressions an hour, with a bonus payment for higher totals), long hours seated on unsuitable and often defective chairs, and fixed screens on desks with modesty panels which did not allow the operator to stretch her legs forward. The judge awarded the two women c6000 damages each plus costs (estimated at about k 100 000). BT is likely to appeal. One plaintiff had worked for BT in Cardiff from 1979, keying with her middle fingers only at 11 500 per hour until RSI began to hamper her performance. In late 1983 pain started in her thumbs and though she continued working the condition of her hands deteriorated. Her thumbs began to curl across her palms causing severe pain. The pain moved into her wrists, arms, and then shoulders and neck. In September, 1984, she read a trade union circular about tenosynovitis and she went to see her general practitioner, who diagnosed tenosynovitis ("tennis elbow"). She did not return to work until Nov 16, when, at her request, she was transferred to clerical duties. It was accepted that her condition fell within the category of RSI or work-related upper-limb disorder. However, the medical witnesses disagreed about the significance of certain causative elements of RSI. The plaintiffs and the defendant’s consultants agreed that pressures, subjectively experienced by the individual as a response to her work or home environment, her posture, and the ergonomics of her workstation, all made the operator more vulnerable to RSI. If through her ignorance of the risks an operator soldiered on, the condition might become chronic. The engineers would not remove the modesty panels for fear of destabilising the desks and damaging wires and conduits. The plaintiff had opened a drawer and put her feet on it to give her legs more room, and most of the operators did something like that. All the operators called as witnesses said that they were given no training or warning that posture was important. It was alleged by the plaintiffs that BT failed to provide suitable adjustable chairs and footrests. "Management’s laissez-faire attitude towards bad posture" would, the judge said, have done nothing to alert operators about the dangers. The plaintiff had sometimes had to work on a chair which could not be adjusted properly, and this would have increased the risk of musculoskeletal injury. The judge made similar findings of causation for the RSIin the second plaintiff, who had worked for BT in Swindon. Posture and defective office furniture apart, the cases before Judge Byrt focused on what BT knew or might reasonably be expected to have known about RSI at the
concluded that the constrained postures at VDUs can a small proportion of operators, injuries in muscle and tendons. In 1982, BT provided guidance on VDUs which noted that "special attention has to be given to those parts of the musculoskeletal system of the body which are likely to remain comparatively static". Unfortunately, the BT guidelines expressly excluded their application where VDUs were used on a "full-scale dedicated basis" -which is exactly the kind of unit where the two plaintiffs worked. Nevertheless, the judge was not satisfied that BT knew enough about the causal connection between RSI and keyboard work to warrant radical action in time to have spared the plaintiffs injury. Between 1980 and 1984, there had been "a gap in the literature". The issue of the Australian Health and Safety Bulletin of August, 1982, had only been received in the UK in January, 1985. It would not in any event have been sufficient to "fix BT with constructive knowledge", a lawyer’s way of saying "BT should have known". Even when BT’s medical team had convinced itself of the connection between RSI and keyboard work the remedy would have lain in a reconsideration of flexitime rules, proficiency allowances, or the monitoring procedures, and would have required workforce cooperation. On the other hand the judge was satisfied that BT knew or ought to have known that postures of the sort adopted by these operators were likely to cause serious musculoskeletal injury. BT was responsible for ensuring that bad postures were corrected. The problem was the posture, not the injury, and the workforce was engaged in a task which the occupational medicine team should have known was potentially stressful. Those doctors should have advised that managers must be fully informed that staff would be vulnerable to injury unless their posture conformed to well-defined guidelines. Had the 1982 instruction been circulated more widely the plaintiffs might have escaped the worst effects of RSI. The combination of intensive, repetitive keyboard work and poor posture was responsible, and poor posture was a substantial contributor. The judge also found that BT’s failure to provide suitable chairs
produce, in
238
amounted to a breach of their statutory duty. However, BT’s failure to warn of the risk that keyboard work might cause RSI to new recruits or to encourage workers to report any aches and pains at onset did not amount to a breach of
statutory duty. Diana Brahams
Conference AIDS in Africa 1 in 40 African adults is now infected with HIV. These 6 million women and men, and the three-quarters of a million infected children, are unevenly distributed over the continent. In East Africa the real burden of disease and death is only just beginning to be felt, but already AIDS cases make up to 80% of the case-load in some adult hospital wards. Practically everywhere the number of people with asymptomatic HIV infections is multiplying rapidly. 1 in 8 adults in Abidjan now carry HIV 1 or HIV 2. The burden of associated diseases is overwhelming: 40% of patients dying from AIDS have cerebral lesions, most commonly toxoplasmosis and tuberculosis. Already there are 50 000 AIDS orphans in just one region (Kagera) in Tanzania, and agricultural production in the same area has fallen by 3-20%. Yet only a small fraction of those infected with HIV in any part of Africa have died. From the point of view of cost to the community and health services the epidemic is
only just beginning. The Sixth International Conference
on
graciously opened by the President of Senegal, Monsieur Aboon Diouf, and even President Bush sent a message. Finally, such conferences disseminate information to the rest of the world. For example, studies in Nairobi suggest that the use of oral contraceptives and intrauterine devices is associated with any increased or reduced risk of seroconversion, and data from Cameroon give some preliminary evidence of a protective effect of spermicide use on the acquisition of HIV. More evidence is accumulating about the long incubation period of HIV-2. But despite much of interest, many of the outcomes of the meeting might have been achieved more cost-effectively. Perhaps the several, much smaller, satellite meetings by WHO/GPA, Family Health International, and Bristol Myers Squibb held in Dakar are a more appropriate model for the future. Certainly another world conference in Amsterdam in the middle of 1992 and a Seventh AIDS in Africa conference in Yaounde at the end of next year seems a bit like conference overload. One participant, who has known AIDS for longer and more closely than most, saw the Dakar meeting "as a rerun of the first AIDS in Africa conference in Brussels in 1985 but with the decimal point moved". In other words, HIV prevalences continue to rise and even experts do not always learn quickly enough.
not
International First Floor,
Family Health,
Margaret Pyke Centre, 15 Bateman’s Buildings, London W1V 5TW
Malcolm Potts
AIDS in Africa
(Dec 16-18, 1991) brought 1800 participants from 79 countries to Dakar, Senegal. Many conference presentations measured the spread of HIV or threw light on the
knowledge and attitudes of vulnerable groups such as prostitutes and their clients. Less than 10% of commercial sex workers in one Cameroon sample used condoms regularly and 60% of long-distance lorry drivers in Zimbabwe have sex with a prostitute at least once a month. Somewhat fewer papers dealt with preventive measures such as education, distribution of condoms, or treatment of other sexually transmitted diseases (STD). The poverty of the Sahel, political unrest in Zaire, debt burdens in Nigeria, and the legacy of previous bad government in Uganda are all factors mitigating against disease control. So is the low status of women. In many parts of Africa women handle much of the subsistence farming and petty commerce but receive the least reward. Even so, there have been successes in HIV prevention: prostitutes in Ghana have changed their behaviour, the social marketing of condoms in Zaire has been most successful, and the comprehensive control of STDs through government services has been initiated in Tanzania. The challenge is to develop the will and mobilise the resources (national and international) to turn pilot projects into epidemiologically significant programmes. At present, however, it is difficult to escape the conclusion that HIV is out of control. Among other things, it must also be asked whether large, expensive conferences are themselves an appropriate response? Conferences help forge needed partnerships between developing and developed countries and are certainly essential for recharging the skills and motivation for those fighting in the trenches in the battle against AIDS. Scientists from Belgium, France, and the USA played an important part in the Dakar meeting. Conferences also allow national leaders to express support: the sixth conference was
Noticeboard Safeguards for gene therapy Somatic gene
therapy
will be allowed in the UK if the
recommendations of the Committee on the Ethics of Gene Therapy are accepted by the Government. But the Department of Health will be seeking the views of many professional and lay organisations before the Government reaches its decision. The consultation period will end on May 18. Any proposed gene therapy must be ethically acceptable and shown to be safe, says the committee’s report, published last week.’ The committee, a non-statutory body set up by UK health ministers in 1989 under the chairmanship of Sir Cecil Clothier, QC, says that gene therapy raises no new ethical issues, but because the treatment is new it recommends that gene therapy should be subject to the ethical codes that apply to research involving patients. Familiar ethical considerations that are likely to assume greater prominence when gene therapy is being considered include safety (because of the possibility of unpredicted consequences of gene insertion), the need for long-term surveillance, consent (especially regarding uncertainties about outcome), the probability that children will be among the first candidates for gene therapy, and
confidentiality. Gene therapy, the committee recommends, should be restricted to the alleviation of disease in individual patients and should not be used to change normal human traits. The first candidates for gene therapy should be patients with a lifethreatening or seriously disabling genetic disease. Severe genetic disorders that show their effects in early childhood, or even before birth, should be treated correspondingly early. Germline gene therapy should not be attempted at present, says the report, because "there is insufficient knowledge to evaluate the risk to future generations". At a meeting of the Human Genome Organisation in London last August Dame Mary Warnock, chairman of the 1984 committee that approved in-vitro fertilisation and limited research on human embryos, said that unpredictable outcome was a more valid reason for rejecting germline therapy than was
fear of doctors’ powers.
