1
239 In drawing up its guidelines the Clothier Committee took account of the public’s concerns about "a procedure which could be used to change human characteristics" and irrational fears "which derive from misunderstandings of biology ... and popular creations of fiction, such as Frankenstein’s monster". The committee proposes that a non-statutory expert advisory board be set up to work in conjunction with local research ethics committees to assess proposals for gene therapy, including its supervision. Until substantive arrangements for assessment are in place proposals for gene therapy should be submitted to the local research ethics committee and to the Clothier Committee. 1. Report of the Committee on the Ethics of Gene Therapy. Cm 1788. London: HM Stationery Office. 1992. £6. Pp 90 ISBN 0-101178824. Trial by myth US criminal courts perpetuate stereotypes of patients with AIDS and frequently contradict current knowledge on the risk factors of HIV infection. So says the second report of the US AIDS Litigation Project, an ongoing investigation funded jointly by the National AIDS Program Office and the US Public Health Serviced The aim of this scheme is to promote wider knowledge among the legal profession and public about laws concerning the rights of AIDS patients. The latest report discusses 817 cases, most of which focus on alleged discrimination and criminal law litigation. Not only is HIV disease a major scientific and public health issue in both the developing and the developed world, but it is also, to quote Dr Jim Allen, Director of the National AIDS Program Office, "the most litigated disease in history". Prosecutions have been made against HIV-positive people on the basis of attempted murder and assault with a deadly weapon. Courts have shown little understanding of the relative risks of behaviours that might be associated with the transmission of HIV. Judges seem to have difficulty in deciding whether and, if so, how the outcome of an act (which may be inconsequential), the act itself (such as a bite), or the intention behind the act should be punished. Health insurance is a particular cause for concern. A company has already tried to bring an action to annul retrospectively a policy after the deceased was found to be HIV positive, even though that individual was unaware of his antibody status. The failure of the judiciary to defend the human rights of those with HIV infection is, the report notes, a reflection of the poor AIDS education policy of the current Bush administration. Combined with the recent debacle over entry of HIV-positive delegates to the US for an AIDS conference, the US Government and its instruments of state continue to give negative signals to a population in desperate need of an aggressive but fair public health education programme about HIV disease. 1 Gostin L, Porter L. The AIDS Litigation Project II: a national review of court and Human Rights Commission decisions. Washington DC: US Public Health Service, 1992. Pp 372 Copies available from National AIDS Program Office, Humphrey Building, 200 Independence Avenue SW, Washington DC, 20201, USA. Reassurance on safety of pertussis vaccines A report commissioned by the US Government provides reassurance that the risks of severe permanent adverse effects after pertussis vaccination are very low. The report was a review by the Institute of Medicine (IOM) at the National Academy of Sciences, Washington DC, of information on possible adverse consequences of pertussis and rubella vaccines. It was released in August, 1991, and has been summarised in the Jan 15 issue of the Journal of the American Medical Association.1 The IOM review examined 18 adverse effects in relation to DTP vaccine and 4 in relation to the currently used vaccine strain RA 27/B. Evidence for a causal relation with pertussis vaccine was found for four adverse effects, and that with rubella vaccine for two. For DTP, evidence "consistent with a causal relation" was found for acute encephalopathy (range of excess risks 00 to 10-5 per million immunisations). The IOM concludes that this degree of risk is consistent with that reported by the UK National Childhood Encephalopathy Study the only large case-control study of vaccine-related encephalopathy so far. The NCES had concluded that the data suggested but did not prove that DTP causes serious acute neurological disorders in the first 7 days after 1 in 310 000 vaccinations. The IOM also found evidence consistent with a causal relation and for shock and unusual shock-like state (data insufficient for calculation of excess risk but incidence rates 3-5 to 291 per 100 000 immunisations). Stronger evidence of a possible causal relation (ie, evidence that "indicates a causal relation") was found between DTP and anaphylaxis (incidence rates 2 cases per 100 000 injections DTP and 6 per 100 000 children given three doses of DTP) and between the pertussis component of DTP and protracted inconsolable crying (incidence rates 0’ 1 to 6% recipients of a DTP injection). There was insufficient evidence to indicate a causal relation with chronic neurological damage, learning disabilities, and attention deficit disorder. The IOM team was not asked to examine febrile seizures, afebrile seizures, or epilepsy, but did so because these are considered by some to be components of encephalopathy. The conclusion was that the evidence indicates a causal relation between DTP vaccine and febrile seizures but not between DTP vaccine and afebrile seizures. The evidence was insufficient for conclusions to be drawn about epilepsy. 1. Howson CP, Fineberg HV Adverse events following pertussis and rubella vaccine. Summary of a report of the Institute of Medicine. JAMA 1992; 267: 392-96. 2. Alderslade R, Bellman MH, Rawson NSB, Ross EM, Miller DL. The National Childhood Encephalopathy Study. In: Whooping cough: Reports from the Committee on Safety of Medicine and Joint Committee of Vaccination and Immunisation. London: HM Stationery Office. 1981: 79-169. Infections in intensive care Patients in intensive care, already severely ill, are at greatly increased risk ofnosocomial infections, the prevalence in intensive- care units (ICUs) ranging from 13 to 42% compared with 5-10% for hospital-acquired infections in general.1 The first step towards reducing this alarmingly high rate of infection is to improve knowledge of the patterns of infections. The European Prevalence of Infection in Intensive Care (EPIC) study, funded by Roussel Uclaf, has been set up to gather information on the prevalence of infections in ICUs, demographic profiles of infected patients, risk factors (eg, the use of immunosuppressive drugs and invasive procedures), pathogens, and antibiotics prescribed. EPIC is hoping to recruit at least 20% of ICUs in 17 European countries to take part in a one-day point prevalence study, on April 29. Many infections could probably be prevented with simple measures, such as the enforcement of basic handwashing techniques, but even more fundamental is the need to ensure that all members of the ICU team are aware of the extent of infection and have the necessary information to develop priorities for infection control. A report of three separate outbreaks of methicillin-resistant Staphylococcus aureus (MRSA) infection in a Dutch university hospitaP shows the extreme measures sometimes needed to eradicate a resistant organism. The Scutari strategy of isolating infected patients did not work, and SALT (Staph aureus limitation technique) was regarded as unacceptable because it applies less rigorous controls to colonised patients than infected ones. Vandenbroucke-Grauls et al chose instead a more vigorous "search and destroy" approach, which involved isolation of infected patients, search for symptom-free carriers, keeping track of known carriers through hospital records, and isolation and screening of patients coming from other hospitals with MRSA. Further information on the EPIC study is available from Medical Action Communications, Action International House, Crabtree Office Village, Eversley Way, Thorpe, Egham, Surrey TW20 8RY, UK (telephone 0784 434353, fax 0784 431323). 1. Daschner F Nosocomial infections in intensive care units. Intensive Care Med 1985; 11: 284-87. 2. Vandenbroucke-Grauls CM, Frenay HME, van Klingeren B, Savelkoul TF. Control of epidemic methicillin-resistant Staphylococcus aureus in a Dutch university hospital. Eur J Clin Microbiol Infect Dis 1990; 10: 6-11.

Trial by myth

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239

In drawing up its guidelines the Clothier Committee tookaccount of the public’s concerns about "a procedure which could beused to change human characteristics" and irrational fears "whichderive from misunderstandings of biology ... and popular creationsof fiction, such as Frankenstein’s monster".The committee proposes that a non-statutory expert advisory

board be set up to work in conjunction with local research ethicscommittees to assess proposals for gene therapy, including its

supervision. Until substantive arrangements for assessment are inplace proposals for gene therapy should be submitted to the localresearch ethics committee and to the Clothier Committee.

1. Report of the Committee on the Ethics of Gene Therapy. Cm 1788. London: HMStationery Office. 1992. £6. Pp 90 ISBN 0-101178824.

Trial by mythUS criminal courts perpetuate stereotypes of patients with AIDS

and frequently contradict current knowledge on the risk factors ofHIV infection. So says the second report of the US AIDS

Litigation Project, an ongoing investigation funded jointly by theNational AIDS Program Office and the US Public Health ServicedThe aim of this scheme is to promote wider knowledge among thelegal profession and public about laws concerning the rights ofAIDS patients. The latest report discusses 817 cases, most of whichfocus on alleged discrimination and criminal law litigation. Not onlyis HIV disease a major scientific and public health issue in both thedeveloping and the developed world, but it is also, to quote Dr JimAllen, Director of the National AIDS Program Office, "the mostlitigated disease in history". Prosecutions have been made againstHIV-positive people on the basis of attempted murder and assaultwith a deadly weapon. Courts have shown little understanding ofthe relative risks of behaviours that might be associated with thetransmission of HIV. Judges seem to have difficulty in decidingwhether and, if so, how the outcome of an act (which may beinconsequential), the act itself (such as a bite), or the intentionbehind the act should be punished.Health insurance is a particular cause for concern. A company has

already tried to bring an action to annul retrospectively a policy afterthe deceased was found to be HIV positive, even though thatindividual was unaware of his antibody status. The failure of thejudiciary to defend the human rights of those with HIV infection is,the report notes, a reflection of the poor AIDS education policy ofthe current Bush administration. Combined with the recent debacleover entry of HIV-positive delegates to the US for an AIDSconference, the US Government and its instruments of state

continue to give negative signals to a population in desperate need ofan aggressive but fair public health education programme aboutHIV disease.

1 Gostin L, Porter L. The AIDS Litigation Project II: a national review of court andHuman Rights Commission decisions. Washington DC: US Public HealthService, 1992. Pp 372 Copies available from National AIDS Program Office,Humphrey Building, 200 Independence Avenue SW, Washington DC, 20201,USA.

Reassurance on safety of pertussis vaccinesA report commissioned by the US Government provides

reassurance that the risks of severe permanent adverse effects afterpertussis vaccination are very low. The report was a review by theInstitute of Medicine (IOM) at the National Academy of Sciences,Washington DC, of information on possible adverse consequencesof pertussis and rubella vaccines. It was released in August, 1991,and has been summarised in the Jan 15 issue of the Journal of theAmerican Medical Association.1The IOM review examined 18 adverse effects in relation to DTP

vaccine and 4 in relation to the currently used vaccine strain RA27/B. Evidence for a causal relation with pertussis vaccine wasfound for four adverse effects, and that with rubella vaccine for two.For DTP, evidence "consistent with a causal relation" was foundfor acute encephalopathy (range of excess risks 00 to 10-5 permillion immunisations). The IOM concludes that this degree of risk

is consistent with that reported by the UK National ChildhoodEncephalopathy Study the only large case-control study ofvaccine-related encephalopathy so far. The NCES had concludedthat the data suggested but did not prove that DTP causes seriousacute neurological disorders in the first 7 days after 1 in 310 000vaccinations. The IOM also found evidence consistent with a causalrelation and for shock and unusual shock-like state (data insufficientfor calculation of excess risk but incidence rates 3-5 to 291 per100 000 immunisations). Stronger evidence of a possible causalrelation (ie, evidence that "indicates a causal relation") was foundbetween DTP and anaphylaxis (incidence rates 2 cases per 100 000injections DTP and 6 per 100 000 children given three doses ofDTP) and between the pertussis component of DTP and

protracted inconsolable crying (incidence rates 0’ 1 to 6% recipientsof a DTP injection). There was insufficient evidence to indicate acausal relation with chronic neurological damage, learningdisabilities, and attention deficit disorder. The IOM team was notasked to examine febrile seizures, afebrile seizures, or epilepsy, butdid so because these are considered by some to be components ofencephalopathy. The conclusion was that the evidence indicates acausal relation between DTP vaccine and febrile seizures but notbetween DTP vaccine and afebrile seizures. The evidence wasinsufficient for conclusions to be drawn about epilepsy.

1. Howson CP, Fineberg HV Adverse events following pertussis and rubella vaccine.Summary of a report of the Institute of Medicine. JAMA 1992; 267: 392-96.

2. Alderslade R, Bellman MH, Rawson NSB, Ross EM, Miller DL. The NationalChildhood Encephalopathy Study. In: Whooping cough: Reports from theCommittee on Safety of Medicine and Joint Committee of Vaccination andImmunisation. London: HM Stationery Office. 1981: 79-169.

Infections in intensive care

Patients in intensive care, already severely ill, are at greatlyincreased risk ofnosocomial infections, the prevalence in intensive-care units (ICUs) ranging from 13 to 42% compared with 5-10%for hospital-acquired infections in general.1 The first step towardsreducing this alarmingly high rate of infection is to improveknowledge of the patterns of infections. The European Prevalenceof Infection in Intensive Care (EPIC) study, funded by RousselUclaf, has been set up to gather information on the prevalence ofinfections in ICUs, demographic profiles of infected patients, riskfactors (eg, the use of immunosuppressive drugs and invasiveprocedures), pathogens, and antibiotics prescribed. EPIC is hopingto recruit at least 20% of ICUs in 17 European countries to take partin a one-day point prevalence study, on April 29. Many infectionscould probably be prevented with simple measures, such as theenforcement of basic handwashing techniques, but even morefundamental is the need to ensure that all members of the ICU teamare aware of the extent of infection and have the necessaryinformation to develop priorities for infection control.A report of three separate outbreaks of methicillin-resistant

Staphylococcus aureus (MRSA) infection in a Dutch universityhospitaP shows the extreme measures sometimes needed to

eradicate a resistant organism. The Scutari strategy of isolatinginfected patients did not work, and SALT (Staph aureus limitationtechnique) was regarded as unacceptable because it applies lessrigorous controls to colonised patients than infected ones.

Vandenbroucke-Grauls et al chose instead a more vigorous "searchand destroy" approach, which involved isolation of infected

patients, search for symptom-free carriers, keeping track of knowncarriers through hospital records, and isolation and screening ofpatients coming from other hospitals with MRSA.

Further information on the EPIC study is available from Medical ActionCommunications, Action International House, Crabtree Office Village,Eversley Way, Thorpe, Egham, Surrey TW20 8RY, UK (telephone 0784434353, fax 0784 431323).

1. Daschner F Nosocomial infections in intensive care units. Intensive Care Med 1985;11: 284-87.

2. Vandenbroucke-Grauls CM, Frenay HME, van Klingeren B, Savelkoul TF. Controlof epidemic methicillin-resistant Staphylococcus aureus in a Dutch universityhospital. Eur J Clin Microbiol Infect Dis 1990; 10: 6-11.