Ethics versus evidence in influenza vaccination

Ethics versus evidence in influenza vaccination

Comment suprapubic pressure on the anterior shoulder. Should these fail, the attendant must be prepared to do internal manoeuvres, and these are done...

70KB Sizes 1 Downloads 49 Views

Comment

suprapubic pressure on the anterior shoulder. Should these fail, the attendant must be prepared to do internal manoeuvres, and these are done with most ease and speed when a generous mediolateral episiotomy is done without delay. Reluctance to do an episiotomy might hamper internal manoeuvres, thus contributing to harm and perhaps even increasing the risk of brachial plexus injury to the baby.

1 2 3 4

5

Andrew C G Breeze, *Christoph C Lees Division of Maternal-Fetal Medicine, Addenbrooke’s Hospital, Cambridge, CB2 2QQ, UK [email protected] We declare that we have no conflict of interest.

6 7 8

James, DK, High risk pregnancy : management options, 2nd edn. London: Saunders, 1999. Baskett TF, Allen AC. Perinatal implications of shoulder dystocia. Obstet Gynecol 1995; 86: 14–17. Confidential Enquiry into Stillbirths and Deaths in Infancy, 6th annual report, London: Maternal and Child Health Research Consortium, 1999. Gurewitsch ED, Donithan M, Stallings SP, et al, Episiotomy versus fetal manipulation in managing severe shoulder dystocia: a comparison of outcomes. Am J Obstet Gynecol 2004; 191: 911–16. Bodner-Adler B, Bodner K, Kaider A, et al. Risk factors for third-degree perineal tears in vaginal delivery, with an analysis of episiotomy types. J Reprod Med 2001; 46: 752–56. Sleep J, Grant A, Garcia J, Elbourne D, Spencer J, Chalmers I. West Berkshire perineal management trial. BMJ Clin Res Ed 1984; 289: 587–90. Argentine Episiotomy Trial Collaborative Group. Routine vs selective episiotomy: a randomised controlled trial. Lancet 1993; 342: 1517–18. Lurie S, Ben-Arie A, Hagay Z. The ABC of shoulder dystocia management. Asia Oceania J Obstet Gynaecol 1994; 20: 195–97.

Ethics versus evidence in influenza vaccination

www.thelancet.com Vol 364 December 18/25, 2004

pre-existing cardiac, respiratory, or other coexisting morbidity, which puts them at greater risk of severe influenza. Although the USA has one of the highest per-capita uses of influenza vaccine in the world,4 it is still a long way short of universal vaccination, and the recommendations for vaccination are also clearly targeted at the population groups most at risk of the severe disease caused by influenza infection.5

Science Photo Library

Being alive is a risky business. How many hours of sitting in a smoky environment increases the risk of lung cancer? How much sunlight on skin will promote melanoma? What will be the outcome of a casual sexual encounter? Are we candidates for a myocardial infarct after decades of western diet? The “prime characteristic of modern industrial civilisation is a society that sees the future as territory to be conquered or colonised”, said Gibbens in a Reith Lecture.1 Our concept of risk has evolved from primitive star-gazing to spot omens of bad fortune, to the active management of hazards that might occur in the future. Where health care is concerned, we mostly agree that risks of death, dying, and disease are to be minimised. And so we legislate to reduce smoking in public places, distribute condoms, wear suncream, eat low-cholesterol diets, and vaccinate various age groups—just a few of many measures designed to reduce the hazard of disease in our society. The objective of influenza vaccination is to reduce disease and dying from infection with a virus that will circulate somewhere on the planet during the course of a year. Each influenza season is different from the last; experienced hands avoid the trap of trying to predict the future. Indeed the recent withdrawal of Fluvirin influenza vaccine from the market, following manufacturing problems at the Chiron production plant in Liverpool, UK,2 was totally unpredictable, as are so many events in the world of influenza. Vaccine supply and distribution is a global operation and is subject to various supply-chain problems. Market forces prevail. The knock-on effects of loss of one manufacturer’s biological product in 2004 in the UK means that about half of the vaccine supply destined for another country, the USA, has disappeared, despite relatively little effect on the vaccine supply in the UK. The risk of hospital admission for influenza increases above the age of 50 years,3 as does the risk of dying from influenza. In Europe, vaccination is mainly targeted at people over 65 years of age and younger adults at risk with

Although the duration and magnitude of influenza virus epidemics might vary, we are unlikely to interrupt transmission of infection with this approach to mass vaccination. The 2003–04 winter season in the USA and the UK was a stark reminder of the potential lethality of influenza infection in children, with 143 deaths attributed to influenza in the USA and 17 in the UK,6,7 mostly in unvaccinated children. Aside from the desirable goal of reducing 2161

Comment

morbidity due to influenza in children, there is renewed interest in vaccination of children to interrupt transmission of influenza in the population, thereby potentially reducing the number of hospital admissions and deaths in the adult and elderly in an indirect way. Mass vaccination of children would not only reduce disease, admission, and death due to influenza in childhood, but might also have added societal value. Recent randomised trial vaccination studies in communities in the USA, show reduced morbidity in adults over 35 years of age when young children were vaccinated.8 These data are also supported by analysis of morbidity in all age groups in Japan where, for many years, influenza vaccination of children was compulsory.9 In the USA, vaccination recommendations for winter 2004–05 also extend to children over 6 months of age, those over 50 years of age, and pregnant women.5 Vaccine recommendations and distribution figures cannot be assumed to equal verified uptake of vaccine in different sectors of the population. When there are data about who gets influenza vaccine, mass vaccination is predictably more efficient when age is a criterion for vaccination than when clinical risk groups are used.10 The corollary of this is we do not target the vulnerable for vaccination as efficiently as we desire. Why should this be? Perception of risk (or lack of) must play a part in an individual’s decision not to get vaccinated. Have we therefore communicated risk adequately? Less than optimum targeting of interventions might also be an inherent problem in health-care systems that require integrated information to identify and communicate with individuals at risk. Initiatives, such as those launched this winter in England, to introduce web-based national reporting of vaccine uptake in every general practice will eventually provide an efficient system for tracking vaccine delivery.11 For winter 2004–05 in the USA, it is estimated that there will be sufficient vaccine,12 with additional supplies from other manufacturers to ensure that all the groups at highest risk can receive vaccine, albeit with delays in supply. Overall, high rates of national vaccination help buffer vaccine shortfalls because they provide the baseline requirement for planning a future supply of vaccine. This point is important when there is a relatively long lead time for vaccine production, as there is for influenza vaccine, which has an annual cycle requiring 6 months or so between strain selection and the availability of clinical vaccine. The difference between the vaccine supply required for the highest risk population (those over 65 years old) and how much is normally distributed suggests that the greatest clinical effect of influenza in the unvaccinated population in winter 2004 should fall on adults between ages 18 and 65.12 It remains a thorny issue though; would it be better to use limited supplies of vaccine to immunise children, which might have an added benefit of reducing transmission to adults, or to immunise adults older than 50, with the 2162

benefit of reducing hospital admission and severe complications of influenza? In 1941, Sainsbury’s, a major UK supermarket, introduced the Fair Share scheme. The objective was to ensure foodstuffs in short supply were distributed evenly. Successful sales staff had “the knack of keeping happy those customers who are waiting”.13 The parallels between limitations in vaccine supply in 2004 in the USA and with war-time rationing are uncomfortably clear. Given current evidence about the use of influenza vaccine in the western world, in a surprising but creative approach to the prioritisation problem, Julie Gerberding, Director of the US Centers for Disease Control and Prevention (CDC), recently appointed an ethics committee to help decide who gets vaccine in this particular shortfall crisis.14 The appointment of the ethics committee also shows that the CDC recognises that shortfalls in vaccine supply have occurred before15,16 and might do so again. The creation of such an ethics panel might also signify that it is finally accepted that risk communication is not maximally effective when done by panels of technical experts. Public-health personnel selling the message about medicines in short supply to frustrated customers need all the help they can get. Deliberations by an ethics committee are almost certainly going to involve more eloquence than an average expert panel. Can we predict that an ethics committee will come to the same conclusion as a panel of experts about how to use vaccine? Will they use scientific evidence to do so? The evidence supporting vaccination in adults and the increased risk of severe influenza in those with pre-existing morbidity is well accepted; the benefits of influenza vaccination in childhood are less well defined, with evidence in shorter supply. Decisions about mass vaccination must be made wisely and well; eloquence is not a substitute for evidence, but if appropriately harnessed with evidence, the eloquence of ethics committees might prove to be an inspired tool for public-health campaigns seeking to inform people about vaccine use. Would we benefit from such a committee in the UK, where increasing numbers of parents fail to understand the risks to their children of falling herd immunity for measles,17 and most health-care workers are not persuaded that influenza vaccination is worthwhile?18 We have many lessons to learn from this winter’s influenza season, and as is often true, these issues reflect fundamental uncertainties. We cannot say when the next pandemic of influenza will occur, but we do know that vaccine will be in short supply then too.19 National vaccine supplies will probably be affected by events and decisions outside national borders. The more we use vaccine in the period between pandemics, the more probable it is we can obtain sufficient vaccine for high-risk populations in a future pandemic. Making sure that national vaccine supplies are not critically dependent on single manufacturers of vaccine, deciding www.thelancet.com Vol 364 December 18/25, 2004

Comment

how to distribute vaccine in a shortage, and learning how to make difficult choices and communicate those choices well to ensure public confidence, will all help us prepare for the next pandemic. Influenza infection is a risky business, it kills 4000–10 000 people in the UK every winter,20 and a pandemic influenza might kill many millions. Making sure that vaccine gets to the right people is tricky, with or without ethics committees.

8

9

10

11

Maria C Zambon Virus Reference Laboratory, Health Protection Agency Centre for Infection, London NW9 5HT, UK [email protected] I have received honoraria for speaking on vaccine-related matters at scientific conferences. The Health Protection Agency receives funding from several manufacturers of influenza vaccine for contract research. 1 2

3 4

5

6 7

Gibbens A, Reith lecture no.2: risk. Runaway World ISBN 0 415 92719 6, Routledge, 1999. Medicines and Healthcare products Regulatory Agency. Oct 6, 2004: http://www.mhra.gov.uk/news/2004/chironfluvaccine.htm (accessed Dec 13, 2004). Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004; 292: 1333–40. van Essen GA, Palache AM, Farleo E, Fedson DS. Influenza vaccination in 2000: recommendations and vaccine use in 50 developed and rapidly developing countries. Vaccine 2003; 21: 1780–85. Harper SA, Fukuda K, Uyeki TM, and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the advisory committee on immunisation practices (ACIP). MMWR Morbid Mortal Wkly Rep 2004; 53: 1–40. Mitka M. Health officials brace for flu season. JAMA 2004; 292: 1670–71. Wilson LE, Zambon MC, McMenamin J. Influenza associated deaths in children from England and Scotland over the winter 2003/2004. European Virology Conference, Madrid, September, 2004: poster.

12 13 14 15

16

17

18

19 20

Piedra PA, Gaglani MJ, Kozinetz CA, et al. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine Nov 2, 2004 [epub ahead of print). Reichert TA, Sugaya N, Fedson DS, Glezen WP, Simonsen L, Tashiro M. The Japanese experience with vaccinating schoolchildren against influenza. N Engl J Med 2001; 344: 889–96. Irish C, Alli M, Gilham C, Jospeh CA, Watson JM. Influenza vaccine uptake and distribution in England and Wales July 1989–June 1997 Health Trends 1998; 30: 51–55. Donaldson L, Mullally S, Smith J. Update on the influenza and pneumococcal immunisation programmes. London: Department of Health, Aug 9, 2004: http://www.dh.gov.uk/assetRoot/04/08/73/40/ 04087340.pdf (accessed Dec 10, 2004). Treanor J. Weathering the influenza vaccine crisis (2004). N Engl J Med 2004; 351: 2037–40. J Sainsbury plc archives. Fare shares. 2001: http://www.j-sainsbury.co.uk/ museum/ration.htm (accessed Dec 10, 2004). Harris G. US creates ethics panel on priority for flu shots. New York Times Oct 28, 2004: 18. Notice to readers: delayed influenza vaccine availability for 2001–02 season and supplemental recommendations of the advisory committee on immunisation practices. MMWR Morbid Mortal Wkly Rep 2001; 50: 582–85. Interim estimates of populations targeted for influenza vaccination from 2002 national health interview survey data and estimates for 2004 based on influenza shortage priority groups. Atlanta: Centers for Disease Control and Prevention, Oct 11, 2004: http:/www.cdc.gov/flu/professionals/ vaccination/pdf/targetpopchart.pdf (accessed Nov 28, 2004). Jansen VA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ. Measles outbreaks in a population with declining vaccine uptake. Science 2003; 301: 804. Stephenson I, Roper JP, Nicholson KG. Healthcare workers and their attitudes to influenza vaccination. Commun Dis Public Health 2002; 5: 247–52. Fedson DS. Pandemic influenza and the global vaccine supply. Clin Infect Dis 2003; 36: 1552–61. Fleming DM. The contribution of influenza to combined acute respiratory infections, hospital admissions, and deaths in winter. Commun Dis Public Health 2000; 3: 32–38.

How to improve the functions of people with schizophrenia, a leading cause of disability throughout the world,1 is a crucial question in mental health. Cognitive impairment is a core characteristic of schizophrenia and is not caused by chronic illness, treatment, or institutionalisation.2 Relations between neurocognitive deficits and functional outcome in people with schizophrenia have stimulated various approaches to neurocognitive rehabilitation.3,4 Given the limitations of previous studies, such as small sample sizes, study of severely impaired inpatients, and limited periods of study (usually less than a year),3,4 a large longitudinal follow-up study of neurocognitive therapies based on an outpatient sample should be informative. Gerard Hogarty and colleagues5 recently reported on the differential effects of cognitive enhancement therapy on cognition and behaviour compared with enriched supportive therapy. This is the first 2-year randomised trial of the two approaches, and with more than 120 patients. Contrary to many previous naturalistic longitudinal studies,6 Hogarty shows that many cognitive disabilities can be www.thelancet.com Vol 364 December 18/25, 2004

Science Photo Library

Cognitive enhancement therapy for schizophrenia

2163