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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.