Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Tamiflu, the State and informed consent
- Andrew Rouse (20 June 2009)
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H1N1 Time for a rational public health response in the UK?
- Jacky Chambers (22 June 2009)
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Could Glastonbury 2009 be for swine flu what the Haj is for meningitis?
- Roly D Gosling (23 June 2009)
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Views expressed in letter, Tamiflu, the State and informed consent, may well not reflect those of Heart of Birmingham PCT
- Andrew Rouse (24 June 2009)
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Good medical practice?
- Charles Saunders (25 June 2009)
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Expiry dates is that the question
- Isaac otomewo (26 June 2009)
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Response to BMJ letter on antiviral prophylaxis
- Lindsey Davies, Mr Justin McCracken (10 July 2009)
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Re: Response to BMJ letter on antiviral prophylaxis
- Hilary G Pickles (12 July 2009)
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Swine flu vaccine, the state and informed consent
- John Stone (28 July 2009)
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Andrew Rouse, Consultant Heart of Birmingham PCT, birmingham B16 9PA
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Tamiflu, the State and informed consent In 2005 I wrote: “When public policy expects a citizen to take a medication on faith, (because it is impractical to obtain informed consent) it is axiomatic that the benefit-to-harm ratio must be much higher than in the normal “doctor-patient” situation”. Importantly, I do not believe that the circulation of the swine flu virus negates this view and that until the DOH or CMO can produce a credible benefit-to-harm risk analysis, the medical fraternity should not support mass prophylaxis of healthy people. The two licensed indications for the use of antiviral flu medications are: 1. Treatment of an obviously infected person 2. Prevention of infection in a patient who is a contact of a person with flu, but only if treatment can be started within 48 hours. The Health Protection Agency (HPA) has identified a further very novel use for antiviral drugs. In the hope that their use may “slow the spread of disease (swine flu)” [Dr Sue Ibbotson, Regional Director, HPA (West Midlands)] or “reduce the onward spread of virus” [Dr John Watson, Head of Respiratory Division, HPA], the HPA advocates mass prophylaxis of healthy people (school children and teachers). This is a novel policy as there is no suggestion that the myriads of healthy people taking the antiviral drugs will benefit; the intended beneficiaries are the public elsewhere in the UK/world. I am a public health consultant who is expected to prescribe antiviral medications for such mass prophylaxis. I am prepared to do so but only when I am satisfied that people have been truly informed and the likely benefits outweigh the likely risks. 1. Parents and teachers must be aware that they are being asked to take medication for an altruistic purpose and not for their own health gain. Comment: When pupils at Welford Road School, Birmingham were given HPA supervised mass prophylaxis (May 2009) it was very apparent that parents believed that they were getting a special “treatment” that would benefit the child. So great was this faith in Tamiflu that many requested Tamiflu for other asymptomatic family members. 2. The risks and inconveniences of taking medication need to be spelled out by the doctor prescribing the antiviral medication. Comment: I do not know but suspect that ~ 10% of recipients will get nausea, vomiting, diarrhoea, abdominal pain, and headache and ~1% hepatitis, rash, allergic reactions, anaphylaxis, and Stevens-Johnson syndrome. Clearly the HPA accepts that Tamiflu has side effects: “Today the HPA reiterated to me the importance of GPs reporting side- effects in those who have taken Tamiflu – as requested in Friday’s Update 13. GPs should use the MHRA’s YellowCard site to do this.” 3. Those people still inclined to take antiviral medication need to be informed of the benefit that others are likely to reap from their altruistic behaviour. Comment: I doubt any benefit can result, certainly the NNT is enormous – possibly millions. The HPA information sheet used at Welford School gave no hint of the very limited (possibly negative health gain) likely to arise from taking Tamiflu. Unfortunately, whilst developing and implementing their mass prophylaxis programme, the HPA appear not to have addressed these three issues. They certainly they have not produced a “Tamiflu, mass- prophylaxis information sheet”. Nor is local HPU staff able to enlighten me. In fact I suspect they also believe that the benefit-to-risk ratio is minimal or even possibly negative! Even if the HPA cannot clarify these three points someone, presumably someone senior like the Chief Medical Officer, can. In 2005 Carl Hengen wrote: “We have been surprised by the confidence shown in oseltamivir in the national guidance on pandemic influenza. Policymakers should be more transparent in their use of evidence in their decisions”. I surely hope that senior health policymakers have evidence to support their policy but, as Dr Hengen says, they could be more transparent in their decision making. However, until then I will not be prescribing antivirals for mass prophylaxis. http://www.bmj.com/cgi/content/full/331/7526/1203- a?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&author1=Rouse% 2C&andorexacttitle=and&andorexacttitleabs=and&fulltext=flu&a ndorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=date &fdate=1/1/1995&resourcetype=HWCIT,HWELTR http://www.bmj.com/cgi/eletters/331/7526/1203-b#122589 FEEDBACK ON OSELTAMVIR AND SIDE EFFECTS http://www.rcgp.org.uk/clinical_and_research/pandemic_ planning/membership_email_19th_may.aspx Competing interests: None declared |
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Jacky Chambers, Director of Public Health Birmingham B16 9PA
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H1N1 Time for a rational public health response in the UK? Mass prophylaxis of healthy people with antiviral drugs is an irrational, indefensible and ineffective response to the current H1N1 pandemic. A public health policy, which appears to be politically driven, rather than evidence based, deserves to be challenged, especially when its application by the HPA is so inconsistent and confused. In Birmingham, decisions about which healthy children should receive prophylaxis have varied between whole school, no school, single classes, pupils sitting within 1 metre of an index case, and pupils listed on the school register as having medical conditions (which include those who wear glasses). There is no evidence to support mass Tamiflu prophylaxis of this kind when community infection is widespread. Indeed our experience suggests that such policies may promote bad hygiene practices. For instance it would appear that healthy children who received Tamiflu later became symptomatic, presumably through community spread disease, and returned to school whilst unwell (presumably in the belief that this could not be flu). The time has surely come for the public health community to return to some basic principles for managing this pandemic and minimizing its potential harm: - Basic Clinical Principles Provide early, rapid treatment of clinically diagnosed high-risk patients Work with professional autonomy and have the freedom to act swiftly Basic Epidemiological Principles Only swab new cases arising outside epidemic areas Ensure that good, timely epidemiological data drives the operational response Core Public Health Principles Educate the families and communities most at risk about flu and how to prevent spread Retain a public health perspective on the opportunity costs Competing interests: None declared |
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Roly D Gosling, SPR Microbiology North Middlesex University Hospital, N18 1QX
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Gatherings of large susceptible groups with poor levels of hygiene drive epidemics. Last week saw the number of virologically confirmed cases of swine flu double in London (1). Whether this is due to increases in incidence or a reflection of the a broader case definition introduced by the HPA earlier this month (2) the fact remains that swine flu has spread substantially within the UK population. Outbreaks appear small but frequent and few severe infections have been reported. However, next weekend sees the go-ahead of the largest music festival in Europe, where approximately 250,000 (3), mostly under 40 year olds will gather for 3 days in poor sanitary conditions. Could this provide a mechanism to spread the virus from one end of the country to the other? What could be done at this stage? Obviously the festival could be cancelled, but is this necessary when the disease appears so mild? Perhaps allowing much of the population to get exposed and become immune will protect us from worse outbreaks in the winter. At any rate, after next weekend GPs should add in whether cases of flu went to Glastonbury as part of their contact history and we can find out. References: 1.http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1245581501610?p=1231252394302 Accessed 22nd June 2009 2. http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1244023934872 Accessed 22nd June 2009 3. http://www.glastonburyfestivals.co.uk/ Accessed 22nd June 2009 Competing interests: None declared |
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Andrew Rouse, Consultant in Public Health B16 9PA
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I have been asked by the Chief Executive and Director of Communications at Heart of Birmingham PCT to make clear that the views expressed in my letter, Tamiflu, the State and informed consent, are mine and may well not reflect those of Heart of Birmingham Primary Care Trust Competing interests: None declared |
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Charles Saunders, Consultant in Public Health Medicine NHS Fife KY8 5RG
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We’re currently doing a number of things with H1N1 that seem to conflict with good medical practice. These include: encouraging GPs and others to take blood samples for research without seeking informed consent or REC approval; encouraging prescription of tamiflu to people who do not necessarily need it (asymptomatic contacts and possible cases) for a strain of flu that is less severe than seasonal flu and the potential risks to the individual of taking tamiflu outweigh the potential benefits; colluding in the diversion of resources away from everyday health protection and health improvement activities to dealing with what is currently a pandemic of a milder than usual strain of flu. For the avoidance of doubt, these views are my own and not necessarily those of my employer. Competing interests: None declared |
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Isaac otomewo, Prescribng advisor Heart of Birmingham teaching PCT 142 Hagley rd Birmingham B16 9PA
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Once the government had spent millions of pounds stockpiling Tamiflu; I guess maybe they felt they had to use it. The drug’s five-year expiration period has apparently already been all ready been extended. The science tells us that it takes only a ‘point mutation’ for Swine flu to become resistant to Tamiflu. That being the case It seems a little strange that we seem to be handing it out with such gusto Competing interests: None declared |
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Lindsey Davies, National Director of Pandemic Influenza Preparedness Department of Health, Mr Justin McCracken
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Letter to the editor Dear Sir We are writing in response to Andrew Rouse’s letter of 20 June entitled Tamiflu, the State and informed consent, and Jacky Chambers’ subsequent letter of 22 June, and would like to take the opportunity to reply to the points raised and firmly address their criticisms of us. Our policy in responding to this new influenza pandemic is based on sound principles – the public health one of seeking to limit the impact on a population, the scientific one of developing and using evidence to inform decisions, and the management one of thorough planning and preparedness. The Department of Health and the HPA have been consistently clear and open, both in writing and in media broadcasts, that the primary aim of antiviral prophylaxis in the early stages of an epidemic is to attempt to limit the spread of the disease. This approach is set out in both the Department of Health and HPA pandemic plans, is supported by scientific evidence and has been the subject of wide consultation over a number of years. Prophylactic oseltamivir reduces the risk of contacts becoming symptomatic, shedding the virus and infecting others. There is also scientific evidence that treating symptomatic people with oseltamivir can reduce infectiousness. The Department of Health and the HPA have also been open about possible side-effects of oseltamivir. We are conscious that there are limited data available, hence the importance of encouraging reporting of side-effects through the MHRA yellow card mechanism. Finally, it is important to note that the HPA, as an independent body, advises Government on swine flu and medical aspects of disease control but it is Government, and not the HPA, that determines overall policy. It is wholly inappropriate to identify and name individual HPA staff members, when such individuals are reflecting the evidence based position of both the corporate HPA, and the Government. Yours faithfully Professor Lindsey Davies
Mr Justin McCracken
Competing interests: None declared |
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Hilary G Pickles, independent public health consultant 3 Ducks Walk, Twickenham, TW1 2DD
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There may well have appeared to have been good scientific evidence for antiviral prophylaxis, but has it worked? It appears the pandemic may have spread in the UK faster than in countries not using antivirals so freely. We need a full and frank review of the scientific case for containment in theory, and then evaluation as seen in practice, with debate on any discrepancies found. Those who worked so hard to deliver the antiviral strategy to date need to be reassured that the policy-makers will remain well informed and real-evidence-based, and prepared to challenge some sacred cows, like use of the costly antiviral stockpile. Competing interests: None declared |
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John Stone, Contributing editor: Age of Autism London N22
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I am grateful to Andrew Rouse. While I do not necessarily believe everything I read in the Sunday Times I was disconcerted to read that a vaccine for the H1N1 swine flu virus manufactured by Baxter Healthcare is to be made available to the public following a five day trial [1] and that the vaccine is to be offered to the entire population [2] either manufacured by Baxter or GSK. I wonder on this basis what advice doctors such as Rouse will be able to give to members of the public. In the case of Baxter it is particularly troubling since there is still no clear explanation of the mysterious incident earlier this year in which Baxter distributed flu vaccines contaminated by H5N1 avian flu virus [3] as confirmed in a written answer by Lord Darzi to Earl Howe [4], and despite which the World Health Organization handed over the franchise for the manufacture of the new vaccine without demur. [1] Jon Ungoed-Thomas, 'Swine flu vaccine to be cleared after 5 day trial', Sunday Times 12 July 2009, http://www.timesonline.co.uk/tol/news/uk/health/article6690010.ece [2] John Ungoed-Thomas, 'Everyone will get vaccine against swine flu', Sunday Times 12 July 2009, http://www.timesonline.co.uk/tol/news/uk/health/article6689955.ece [3] Helen Branwell, 'Baxter: Product contained live bird flu virus' Toronto Sun 27 February 2009, http://www.torontosun.com/news/canada/2009/02/27/8560781.html [4] House of Lords, Hansard 1 June 2009, http://www.publications.parliament.uk/pa/ld200809/ldhansrd/text/90601w0006.htm Competing interests: Autistic son |
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