Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Spanish "common sense and self control policy" concerning Swine Flu
- Tiago Villanueva, Juan Gérvas (5 September 2009)
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60-90 Million already infected
- Ron Law (5 September 2009)
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Out of the mouths of babes...
- Mark McConnell (6 September 2009)
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Yes, but....
- John Stone (7 September 2009)
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In the information society, nobody thinks!
- BM Hegde (7 September 2009)
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Response to emerging infections already calibrated
- Stephen B Lambert (9 September 2009)
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Mass vaccination against swine flu; could it cause more harm than good?
- Peter J Collignon (11 September 2009)
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Out of the mouths of babes aka The Emperor's New Clothes revisited
- Dr Viera Scheibner (12 September 2009)
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Australian data.
- Peter J Flegg (13 September 2009)
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Because it is a new virus will no one have immunity to it?
- Dr.Nadaraja Bathirunathan (13 September 2009)
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Flu stats vs PR
- Victoria C Bingham (11 December 2009)
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Tiago Villanueva, GP trainee USF AlphaMouro, Algueirão-Rio de Mouro Health Centre Group, Código Postal 2635-367 RIO DE MOURO, Juan Gérvas
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Spain is the first country in the world where physicians have joined a "common sense and self-control" policy concerning swine flu. 40 Spanish blogs (and we're talking of well known blogs belonging to healthcare professionals, which promote Evidence Based Medicine) have joined forces to promote a "common sense" position regarding swine flu through a coordinated action that started at 00,00 hours (Spanish time), 2 September. This means that they all published the same post simultaneously, and many more have been joining the cause. You can learn more more (in Spanish) in www.equipocesca.org The Spanish Medical Association (representing all Spanish physicians, around 200,000) has also joined the "common sense" position http://www.elpais.com/articulo/sociedad/medicos/censuran/alarma/exagerada/creada/nueva/gripe/elpepusoc/20090901elpepusoc (in Spanish). This position has had great impact in the Spanish media (TV, newspapers, magazines, radio, social networks, etc...); you can find more information about this in: http://www.elpais.com/articulo/sociedad/Blogueros/sanitarios/unen/pedir/calma/gripe/elpeputec/20090903elpepusoc_9/Tes (in Spanish) Spanish Common Sense Position: What is swine flu/influenza A? Swine flu is a disease with a mild course in the great majority of cases. It is a virus disease. The virus is similar in swine flu and seasonal flu (the flu of normal winters). Swine flu can produce fever, headache, muscle pain, general malaise, nasal congestion, cough, and sometimes digestive symptoms. Swine flu has the same symptoms as seasonal flu. How do people get infected? Transmission is the same as seasonal flu, because it is transmitted through the droplets that we emit when speaking, coughing or sneezing. We name it as pandemic because there are many people affected in many different countries. It is a new virus A and we have no defence against it. But being very infectious does not means that it is more severe. About the diagnosis There is a quick laboratory test for the diagnosis, but in the case of the swine flu it has low sensibility, of about 35%. That means that even if the test is negative, if you have flu symptoms you may have swine flu (in more than half of the cases, 65%). And what is more important, the advice for caring yourself will be the same in all types of flu. So the test is not useful for mild cases. What can be the expected course of the flu? Data coming from the winter season in the South hemisphere show that most cases (around 95%) have mild or moderate symptoms. The course of the disease might be more complicated in chronic complicated patients (for example, inmunosuppressant diseases), children under 6 month, or patients with some risk factors. How to avoid infection? Basic recommendations are: 1.- Frequent hand-washing (for example, we know that washing hands ten times a day reduces the risk in 50%). 2.- Respiratory hygiene (for example, coughing or sneezing in disposable paper handkerchief and washing hands later; coughing or sneezing on your arm to avoid hand contact; avoiding physical contact when the symptoms are obvious). We do not know if the surgical mask avoids the spread of the epidemic. It is only recommended for sick patients when they are in contact with other people and for the persons who care for them. It is unclear if the anti-virus (oseltamivir-Tamiflu® or zanamivir- Relenza®) stop transmission. Some studies in institutions (as nursing homes) and in family contacts have proved very small benefits. Having in mind that it is a mild flu and these drugs have side effects, the routine use is not recommended. Seasonal flu vaccination is not effective for swine flu. New vaccinations are not yet in the market. We know nothing about its security and effectiveness. In the present moment there are no reasons for keeping calm in view of the number of people affected and number of deaths. What to do in case of symptoms? As stated before, the swine flu symptoms are the same as the seasonal flu. As the old adage says: “the flu last 7 days with treatment and one week without it”. Those people who have severe symptoms should contact their doctor; for example, dyspnoea, breathlessness, chest pain, fainting, sudden worsening of symptoms, or symptoms during more than seven days. Children should contact their doctor if they are under 6 months, or have dyspnoea, breathlessness, or fever for more than three days (72 hours). Most people will have mild symptoms and they will obtain no benefit from the doctor. On the contrary, the wrong use of health services overwhelm them and difficult the correct care of severe flu patients or severe cases in general. So healthy people with mild flu symptoms can carry out their self-care in their own homes with good hygiene and keeping themselves well hydrated and nourished. When suffering from flu it is convenient to avoid crowded places during the first five days. And please remember the recommendations: do not cough without protection, and wash your hand frequently. If symptoms appear, is it necessary to take drugs? Fever by itself is not dangerous. Treat it when there is general malaise. Anti-virus drugs have not proven effective in infections by seasonal flu; at most they decrease symptoms in less than one day. And considering the swine flu we even lack any probe of efficiency. For these reasons anti-virus treatment must be apply only to patients suffering from complications or those who high risk of suffering them. In previously healthy people the risk of side effect can be bigger than the benefits. What about pregnancy? It is well known that pregnancy implies a small increase of the risk for complications in either type of flu (seasonal or swine). Being pregnant does not increase the risk of suffering from swine flu. In case of symptoms it is recommended to contact their doctor. Nevertheless the risk is still very low and a great majority of pregnancies will have a healthy outcome. Conclusions During the swine flu pandemic there will still be myocardial infarction, appendicitis, cardiac failure, diabetes, asthma attack, psychiatry diseases, hip fractures, accidents and thousands of other illness that require medical attention. It is important that patients suffering from swine flu do not panic and overwhelm the system, so hospitals and doctors can continue to treat all patients. For that, it is essential to keep calm and have common sense and self-control in all levels, patients, health professionals, decision makers, politicians and the media. To know more, some selected references: 1. Burch J, Corbett M, Stock C et al. Prescription of anti-influenza drugs for healthy adults: a systematic review and meta- analysis. Lancet Infec Dis. 2009;doi:10.1016/S1473- 3099(09)70199-9. 2. Ellis C, McEven R. Who should receive Tamiflu for swine flu?. BMJ. 2009;339:b2698. 3. Evans D, Cauchemez S, Hayden FG. “Prepandemic” immunization for novel influenza viruses, “swine flu” vaccine, Guillain-Barré syndrome and the detection of rare severe adverse affects. J Infect Dis. 2009;200:321-8. 4. Kitching A, Roche A, Balasegaran S et al. Oseltamivir adherence and side effects among children in three London schools affected by influenza A (H1N1), May 2009. An Internet based cross sectional survey. Eurosurvillance 2009;29:1-4. 5. Jefferson TO, Demicheli V, Di Pietrantonj C et al. Inhibidores de neuraminidasa para la prevención y el tratamiento de la influenza en adultos sanos. www.cochrane.es/gripe/revisiones/CD001265.pdf 6. Sheridan C. Flu vaccine makers upgrade technology and pray for it. Nature Biotechnolgy. 2009;27:489-91. 7. Shun-Shin M, Thompson M, Heneghan C et al. Neuraminidase inhibitors for treatment and prophylasis of influenza in children: systematic review and meta-analysis of randomized controlled trials. BMJ. 2009;339;b3172. 8. Simonsen L, Taylor RJ, Vibourd C et al. Mortality benefits of influenza vaccine in elderly people: an ongoing controversy. Lancet Infect Dis. 2007;7:658-66. 9. Smith S, Demicheli V, Di Pietrantonj C, Harden AR et al. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008;(2):CD004879. 10. White N, Webster R, Govorkovs E et al. What is the optimal therapy for patients with H5N1 infection? PLoS Med. 2009;6:e1000091. 11. CDC H1N1 Flu | Interim Guidance for the Detection of Novel Influenza A Virus Using Rapid Influenza Diagnostic Tests http://www.cdc.gov/h1n1flu/guidance/rapid_testing.htm 12. Amantadine, oseltamivir and zanamivir for the treatment of influenza Review of NICE technology appraisal guidance 5. http://www.nice.org.uk/Guidance/TA168 13. Facemasks and Hand Hygiene to Prevent Influenza Transmission in Households A Randomized Trial. Benjamin J. Cowling et al. Annals of Internal Medicine 2009; 151 Issue 7 14. Jefferson T, Foxlee R, Del Mar C, Dooley L, Ferroni E, Hewak B et al. Physical interventions to interrupt or reduce the spread of respiratory viruses: systematic review. BMJ 2008; 336: 77-80 List of blogs that have joined the common sense position: Amantea: http://amantea.blogia.com/ Aragón y Medicina: http://joseacuenca.espacioblog.com/ ATensión Primaria: http://atensionprimaria.wordpress.com/ Bloc d´un Metge de Familia: http://metgedefamilia.blogspot.com/ Blog de los farmacéuticos rurales: http://www.farmaceuticosrurales.blogspot.com/ Crónicas de Mil en Uno: http://milenuno.blogspot.com/ Docencia en Plasencia: http://docenciaenplasencia.blogspot.com/ El blog de saname: http://elblogdesaname.blogspot.com El consultorio : http://ccbaxter.wordpress.com/ El cuadernillo de enfermería: http://cuadernillosanitario.blogspot.com/ El cuaderno de Epidauro: http://elcuadernodepidauro.blogspot.com/ El Gerente de Mediado: http://gerentedemediado.blogspot.com/ El Supositorio: http://vicentebaos.blogspot.com/ Equipo CESCA: www.equipocesca.org El GIPI http://www.infodoctor.org/gipi/ Humana: http://medicablogs.diariomedico.com/humana/ JMF: vocación y realidad: http://medicablogs.diariomedico.com/medicosjovenes/ Inquietudes en Primaria: http://medicablogs.diariomedico.com/inquietudesap/ Medicina y Melodía: http://medymel.blogspot.com/ Médico Crítico: http://medicocritico.blogspot.com Mi Pediatra: http://mipediatra.tk Mi Pediatra 2.0:http://jomurgar.wordpress.com/ Miles de piedras pequeñas: http://megasalva.blogspot.com/ Mondo Medico: http://mondomedico.wordpress.com/ Museo de la Ciencia: http://museodelaciencia.blogspot.com Nemo Contra: http://nemocontra.blogspot.com/ Pediatra de cabecera: http://pediatradecabecera.com/ Pediatría basada en pruebas: http://www.pediatriabasadaenpruebas.com/ Pella de Gofio del Dr Bonis : http://pelladegofio.blogspot.com/ Pharmacoserías: http://pharmacoserias.blogspot.com/ Polimedicado: http://polimedicado.blogspot.com/ Primum non nocere: http://rafabravo.wordpress.com/ Quid pro quo: http://borinot-mseguid.blogspot.com/ rqgb’s point of view: http://rqgb.wordpress.com/ Salud Comunitaria: https://saludcomunitaria.wordpress.com/ Salud con cosas: http://saludconcosas.blogspot.com/ Saludyotrascosasdecomer: http://saludyotrascosasdecomer.blogspot.com/ Saludyotrascosasdevivir: www.proyectonets.org Sinestesia Digital: http://sinestesiadigital.blogspot.com Competing interests: None declared |
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Ron Law, Risk & Policy Consultant New Zealand
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Using information available from New Zealand and New York City it would appear that 20-30,000 people are infected with this pandemic construct for each death. Given that there have been approximately 3,000 confirmed deaths that would suggest that between 60 million and 90 million people have already been infected by the 2009 H1N1 pandemic influenza virus. Given the USA has 595 deaths that would equate to 12 million to 18 million infections in the USA alone. By any measure this is a very benign influenza virus. New Zealand, for example, normally has 400 influenza deaths each year... (according to official's statements). This year we had 17 deaths so it could be argued that the pandemic has resulted in 383 lives being saved which makes it more effective than any influenza vaccine. Competing interests: None declared |
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Mark McConnell, Staff Internist Tomah VAMC 54601
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On hearing the news of the "pandemic" this past spring, my medically naive daughter asked, "Dad, isn't this the same thing they said about SARS and bird flu?" Her question brought to mind thoughts so nicely articulated in Doshi's article. I am happy that he is such a fine writer as I can refer my dear daughter to this as well as sharing it with patients and staff who are wrestling with how to put well intended information about H1N1 into a useable context. I fully support the idea of categorizing pandemics so that the term has more meaning. I suspect government officials must assume a "worst-case scenario" but we all must, as Doshi reminds us, recognize the costs of our preparation and try to maintain balance. The content and tone of this piece offer me a resource I can share with patients (and my daughter!) to help promote the prudence of practical preparedness without the panic of pandemic. Competing interests: None declared |
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John Stone, Contributing editor: Age of Autism London N22
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I wonder whether Peter Doshi apreciates that employing a measured approach to such events could result in frustrating pharmaceutical industry growth targets? We might get a different view of all this if we looked at the financial models rather than the medical ones. For instance, a report from PriceWaterhouseCoopers last year envisaged a pharmaceutical industry in 2020 which is more than double the size of the present global industry, in which the primary shift of focus is from "treatment to prevention"[1]. This is a lot of prevention. Here are two other interesting financial reports: 'Kids' vaccine market set to quadruple'[2] from November 2007 which projects a quadrupling of the juvenile vaccine market over the period of a decade, and the more recent 'New report forecasts more than doubling of vaccine sales by 2014'[3]. Presently in the UK we already administer 25 vaccines by 13 months of age[4] so you might have thought that the room for expansion was limited. I believe there is an ethical imperative at this juncture to stand back and ask what is happening, and why? [1] PriceWaterhouseCooper, 'Pharma2020: Which path will you take?' [2] http://www.drugresearcher.com/Research-management/Kids-vaccine- market-set-to-quadruple [3] http://www.marketwatch.com/story/new-report-forecasts-more-than- doubling-of-vaccine-sales-by-2013 [4] http://www.immunisation.nhs.uk/Immunisation_schedule/Full_immunisation_schedule Competing interests: None declared |
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BM Hegde, Editor-in-Chief, Journal of the Science of Healing Outcomes Mangalore-575004, India
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Dear Editor, Nobody thinks in information society was the firm opinion of Michael Chrichton, a US trained physician! There is a novel way of testing new vaccines in an emergency pandemic, we are told, by bypassing the regular mandatory human testing. I wonder if the WHO has permitted this to be done by the drug companies! The new European procedure, which was established by the Commission and implemented by the EMEA, allows manufacturers to gain an authorisation for a ‘mock-up’ vaccine before a pandemic has occurred. EMEA explains, in a question answer document, thus: (http://www.emea.europa.eu/pdfs/gene) “A mock-up pandemic influenza vaccine is a vaccine that mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method. However, because the virus strain causing the pandemic is not known, the mock-up vaccine contains another flu strain instead. This is a strain that is not circulating in humans, and to which humans have not been exposed in the past. This enables the company to test its vaccine in preparation for any flu pandemic that may occur in the future, by carrying out studies with the mock-up vaccine that predict how people will react to the vaccine when the strain causing a pandemic is included.” I am a bit concerned, may be the wiser ones amongst us would allay my fears, about a couple of things here. The “mock-up” uses a new strain of ‘Flu vaccine. Does this mean that we have stockpiled many unknown but, potentially dangerous, ‘Flu strains in our laboratories? Is this a normal practice? If the virus has not been exposed to humans thus far, how are we sure that the few individuals that we expose to this new strain are not being made guinea pigs? Even assuming that all the above are fine, when the pandemic hits in future the virus strain would again be a new one like the mock up virus and its reactions could be as unpredictable as that of the mock up virus. Each virus would produce its own individual way of attacking humans. How then are we sure that the mock up bypass is of any guidance? Reminds me of bypassing the coronary epicardial arteries in chronic angina where the culprit is the reduced coronary reserve in the millions of perforating muscular vessels inside the myocardium. Are all bypasses in medicine basically money spinners? This bypassing will give permission to manufacturers to get new vaccines as and when they think fit using whichever strain they think is needed. To me it looks as if we have put the cart before the horse. Long before the pandemic has arrived efforts to make vaccines have begun; rather vaccine manufacturing seems to be our primary concern in a pandemic. I strongly feel the whole science of vaccination needs a re-look in view of the fact that only one viral disease, small-pox, has been successfully eradicated so far by human effort. Every other vaccine could be explained as only a partial success in so far as the virus has only to mutate to bounce back with greater vigour. The vaccine will, of course, be useless in that scenario. Edward Jenner used cow pox virus on James Phipps. Cow pox virus is genetically different from small pox virus. It was T. Z. Holwell, FRCP (London), FRS, who studied the protective power of the Indian Ayurvedic vaccination system prospectively for twenty years in "The Bengall" in the eighteenth century to suggest universal vaccination that has eradicated small pox for ever. (1) Hopefully, all laboratories will have destroyed their stock of that deadly small pox virus. Holwell in his paper to the President and Fellows of the London Royal College in 1767 AD did write that the Indian vaccination was not only effective but done with great care and sophistication. Holwell even noted that the vaccination system existed for “times out of mind” in India, and has been effective for hundreds of years, which he strongly recommended for universal use! I think that his original papers are preserved in the library archives in Regents Park. Recently Douglas C Wallace, a noted US geneticist, who has discovered some extra nuclear mitochondrial DNAs (mtDNA) that are more useful for drug testing and disease prevention in contrast to our conventional Mendalian genetics where only nuclear DNAs are taken into consideration. (2) Using his MITCHIP he has been able to find that Asian herbal medicines are not only effective against many diseases including some infections like malaria that he had tested, but has also shown that the western pharmacology of chemical compounds for a target might even damage the cell in the bargain. Could this be the bane of all our problems with the deadly adverse drug reactions? We might have to take a leaf out of Wallace’s work to think of a new science of vaccination. Another point that worries me is the possibility of multiple vaccinations confusing the human immune system. Children get nearly 20 vaccinations in infancy and many more after that. To cap it, now we have the “mock-up” vaccines also getting ready! Real immunity comes from real disease only. Vaccines create a mild form of the disease and we do not know how effective that mild (forme frustae) disease would be in producing anti-bodies. Lately frequent tetanus toxoid injections have been shown to be useless if not dangerous. One could easily understand the anxiety and enthusiasm to produce vaccines. The latter is the best business as the whole world becomes vaccine customers for the business. My worry is: could the recent spurt in auto-immune diseases have anything to do with this preventive strategy of modern medicine? I could be wrong but, just in case someone has an answer!! One lead here seems apt. African Americans have the highest incidence of autoimmune diseases compared the Caucasians, while Africans in Africa have very low incidence of autoimmunity. While there could be many imponderables, but one that might connect the two is that Africans have many kinds of germs that their immune system has to fight against for survival. Their nearly 150 odd genes that oversee the immune system are busily engaged. While African Americans live in a relatively germ free sterile environment in the US compared to Africa. May be the genes have no work to do. Could they become naughty and produce anti-bodies against their own body cells? (Horror auto-toxicus of Paul Ehrlich?) Yours ever, bmhedge References: 1) Hegde BM. Vaccination system in India. 1998; 46: 472-473. 2) Wallace DC. Mitochondrial Chi. Genetics 2008; 179: 727-735. Competing interests: None declared |
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Stephen B Lambert, Medical Epidemiologist Queensland Paediatric Infectious Diseases Laboratory, Royal Children's Hospital, Herston QLD 4029
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Peter Doshi presents some interesting thoughts on the current H1N1 outbreak and its wider ramifications for future outbreaks of newly emerged human pathogens (1).Distilled, the central themes of the paper are: 1. That the response to the pandemic may have been unnecessarily aggressive; 2. That early response was driven by concern generated by inappropriate diagnostic laboratory testing producing potentially biased prevalence estimates; and 3. Response to future outbreaks of novel and emerging infections may be better targeted by use of a two-dimensional framework, which classifies such events on disease severity and numbers infected. Starting with the last of these first, whilst the framework is interesting as a piece of reflection, as a construct for planning an urgent response to a newly emerged agent it is, I would argue, impractical. Firstly, values that would allow one to place an outbreak correctly in any four of the described planes are not available at the time a response is required. For disease severity, even Doshi acknowledges that decisions on the initial response were being made at a time when such information was incomplete. In the US a nationwide public health emergency was declared on April 26 with 20 cases and no deaths, but evidence of severe disease from Mexico. With the information available at that time, when response measures were required and public health officials would have been derelict not to act, where on the x-axis does this pandemic go? Clinical severity is even more troublesome. There are two qualities that make the y-axis variable different to the x-axis: the number of cases is both outbreak duration dependent and reliant on the success of control efforts. Placement on this axis too early in an outbreak, when cases are few, may result in an insufficient response resulting in continued disease transmission and human suffering that may have been stopped with early, aggressive intervention. At what time-point during the 2003 global SARS outbreak did it become clear that cases would not exceed 10,000? I would argue it was many months after the time when action was required and taken, and that said action greatly limited the spread of the outbreak. These are features we can only be certain of in the comfort of hindsight. Doshi implies that the response to the H1N1 pandemic may have been unnecessarily aggressive. But even now he appears unprepared to place H1N1 pandemic on his framework for guiding action. H1N1 may prove (my emphasis) to be type 3: if we can’t definitively characterise H1N1 some four months after the first cases were identified, in what time frame will this construct allow us to calibrate response? Finally, Doshi suggests that the increase in diagnostic laboratory testing may have led to misperceptions about the outbreak and may even have biased our understanding. Laboratory testing has greatly assisted our understanding of influenza epidemiology. No distinction could be made between seasonal and pandemic influenza in 1918 as the viral cause of influenza was first reported in 1931 (2). The advent of highly sensitive and specific nucleic acid tests has, in recent years, revolutionised virology, and real-time RT-PCR assays were available for pandemic (H1N1) 2009 virus within weeks of the discovery of this new variant (3). Laboratory testing played an important role in informing national response in Australia during our winter season, including the declaration of phases and planned responses, in line with the National Pandemic Plan (4). Doshi suggests that results of laboratory testing drove concern and anxiety about the H1N1 outbreak and that this, rather than the pandemic itself, forced potentially unnecessary action. Even a pandemic influenza virus that causes typical influenza disease will have substantial impact: in Australia over our flu season we have had 162 identified deaths, and despite being at the end of our outbreak, 334 people remain in hospital (5). Indigenous Australians and pregnant women were disproportionately affected. Laboratory testing reflects what is happening in the community; it doesn’t generate but merely confirms cases, and given deaths and hospitalisations occur, it would be unreasonable not to provide this information to the public, particularly those at increased risk. At the height of our H1N1 outbreak in Australia influenza was detected in 67% of specimens submitted, and 91% of typed influenza viruses were the pandemic strain (6). There was little influenza B around removing a role for point- of-care testing in artificially increasing the proportion of specimens positive (1). The worried well effect described would increase the number of negative specimens collected thereby reducing the proportion of all specimens positive for the agent of interest. The Swedish data Doshi cites account for only 79 people coming from endemic countries – this compares with tens of thousands of specimens collected and tested in such countries. Whilst interesting, their importance should not be overstated. Without further detail it is difficult to understand how the suggested “ongoing randomised sampling” should be performed: is the sampling frame the entire population or just symptomatic people? If the later, how is this group to be identified and sampled without feeding into the concern bias Doshi is attempting to prevent? Most things are clearer on reflection. Public health authorities attempting to deal with emerging infections that may have catastrophic effects on human health and safety need to act promptly with available information to hand, including laboratory testing data. In such emergencies, the calibrated response is assessed and adjusted daily. Doshi’s framework is interesting, but can only be accurately completed in hindsight, it is not a tool to guide immediate response. References 1. Doshi P. Calibrated response to emerging infections. BMJ 2009;339:b3471. 2. Shope RE. Swine influenza I: Experimental transmission and pathology. J Exp Med 1931;54:349-359. 3. Whiley DM, Bialasiewicz S, Bletchly C, et al. Detection of novel influenza A(H1N1) virus by real-time RT-PCR. J Clin Virol 2009;45:203-204. 4. Commonwealth of Australia. National Action Plan for Human Influenza Pandemic. 2009. The Department of the Prime Minister and Cabinet, One National Circuit, Barton ACT 2600 Australia. http://www.dpmc.gov.au/publications/pandemic/docs/NAP.pdf 5. Commonwealth Department of Health and Ageing. Pandemic (H1N1) 2009 update bulletin. 09 September 2009. http://www.healthemergency.gov.au/internet/healthemergency/publishing.nsf/Content/updates 6. Kelly H, Grant K. Interim analysis of pandemic influenza (H1N1) 2009 in Australia: surveillance trends, age of infection and effectiveness of seasonal vaccination. Eurosurv 2009;14:1-5. Competing interests: SBL is a co-investigator in a CSL sponsored paediatric swine flu vaccine study and was the WHO team leader in Singapore during the 2003 SARS outbreak. |
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Peter J Collignon, ID Physician and Microbiologist Canberra 2607
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Dear Editors Mass vaccination against swine flu; could it cause more harm than good? Dear Sir, Doshi (1) appropriately highlights the need for public health responses to take into account the severity of any new infection as well as its ability to spread. US Department of Health and Human Services, too, in 2005 called for a graduated response in its pandemic preparedness plan (2). It introduced a five-step "pandemic severity index" stratified by the case fatality ratio (category 1 is for a pandemic with case fatality ratio <0.1%). This “swine flu” pandemic, while it spread readily, appears to have a very low mortality rate (less than 1 per 10,000 infected) (3,4). It thus seems inappropriate that we should rush into what must be the world’s largest ever mass vaccination program but with vaccines that have had potentially less than optimal safety and efficacy studies performed. Rolling it out in multi-dose vials also has the inherent increased risk of cross infections with bacteria and blood borne virus infections (5,6). We need to be sure with any vaccination program that the benefits will substantially outweigh the risks. That is not at all clear with this pandemic. Inappropriate levels of fear have already pushed us into inappropriate responses. One example is the gross overuse of oseltamivir. Fear has caused many people who should have stayed home and recovered uneventfully with a mild illness, to seek medical help and treatment. These actions likely spread infection in the facilities they visited and while travelling. In addition such behaviour limits access to medical care to those who had risk factors and did need to be seen promptly for either therapy of prophylaxis. The Northern hemisphere is about to enter the autumn and winter seasons. There are now good data available from New Zealand (7) and Australia (3,4) on what might be expected in winter when unvaccinated populations are exposed to this new variant strain of influenza. The best up to date data that is age stratified is from NSW Health (3). It and the other Australian data (4) show now that this flu episode is close to ending (it peaked early and unexpectedly in mid July). The data show that this flu season has not been much worse overall than 2007 (although certain subgroups e.g. pregnant women have been overrepresented in hospital and ICU admissions). The death rate in the population was low, about 0.6 per 100,000 people (3,4). Overall admission rates were not high either compared to seasonal influenza (usually around 15 per 100,000 per). ICU admissions were 2.7 per 100,000 population. There are about 200,000 pregnant women at any one time in Australia. My estimate for death was about 2 per 100,000 pregnant women. While hospital admission rates are available broken down by age group, similar data is not available for deaths. My calculations of deaths by age group are based on the data in these reports (Table 1). Worldwide we are about to rollout one of the biggest and most rapid vaccine campaigns ever undertaken. Reported inactivated vaccine efficacy is between 50 to 80% (8). Thus for every 1 million people vaccinated we will decrease the number of deaths from 6 to 2 or 3 people. We will also prevent between 75 to 120 hospital admissions and 13 to 22 ICU admissions. Given the relative lack of infections we are seeing in the elderly, it appears that most people over 60 years are already immune (presumable from previous H1N1 infection). Now also probably at least 20% of under-60 year old Australians have already been infected. Thus potentially only about 60% of the Australian population may benefit from mass vaccination if H1N1 returns next winter. We need to weigh this against the risks of vaccination. There will probably be between 1 to 2 additional episodes of Guillain-Barré syndrome per million vaccine recipients (5,8). If we have a repeat of the 1976 US swine flu vaccination roll-out then there may be 10 cases per million vaccine recipients. We also need to estimate how many bacterial and blood borne virus infections we might expect from the use of multi-use vials (5,6). Australia is approaching its spring. There is no need here to rush into a mass vaccination programme particularly using multi-dose vials. In the Northern hemisphere, rapid assessment of different age groups and at- risk groups is needed re their risk and rates of death or severe infection. This is to ensure that vaccination policy is appropriately targeted to the threat of H1N1 and based on the extensive data now available from winter in the Southern Hemisphere and the previous summer in the Northern hemisphere. Mass vaccination will not be appropriate unless likely benefits substantially outweigh likely risk in many of the age groups. Table 1 Number of admissions Deaths admissions rate deathrate Under 40 724 5 17.9 0.12 40-49 132 8 13.3 0.81 50-59 186 15 20.9 1.69 60-69 78 7 11.9 1.07 70+ 70 11 10.5 1.64 Total 1190 46 17.1 0.66 Rate per 100,000 population (NSW) (3) References 1. Doshi P. Calibrated response to emerging infections. BMJ. 2009 Sep 3;339:b3471. doi: 10.1136/bmj.b3471. http://www.bmj.com/cgi/content/full/bmj.b3471?ijkey=tKcb8W6KUoHXzPC&keytype=ref. [accessed September 11, 2009]. 2. Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States. February 2007. CDC Atlanta. http://www.flu.gov/professional/community/mitigation.html [accessed September 11, 2009]. 3. Weekly Influenza Epidemiology Report, NSW. Including H1N1 influenza 09 Prepared by the Population Health Division, 2 September 2009. NSW Health. http://www.emergency.health.nsw.gov.au/swineflu/resources/pdf/case_statistics_270809.pdf [accessed September 11, 2009]. 4. AUSTRALIAN INFLUENZA SURVEILLANCE SUMMARY REPORT No.16, 2009, REPORTING PERIOD: 22 August 2009 – 28 August 2009. http://www.healthemergency.gov.au/internet/healthemergency/publishing.nsf/Content/ozflucurrent.htm 5. Sweet M and Collignon P. Why can’t we have a rational discussion about the merits of pandemic flu vaccination? August 31, 2009. Croakey. http://blogs.crikey.com.au/croakey/2009/08/31/why-cant-we-have-a-rational- discussion-about-the-merits-of-pandemic-flu-vaccination/?source=cmailer [accessed September 11, 2009]. 6. Drain PK, Nelson CM, Lloyd JS. Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries. Bull World Health Organ. 2003;81(10):726-31. 7. Baker MG, Wilson N, Huang QS, Paine S, et al. Pandemic influenza A(H1N1)v in New Zealand: the experience from April to August 2009. EuroSurveill. 2009 Aug 27;14(34). http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19319 [accessed September 11, 2009]. 8. Demicheli V, Di Pietrantonj C, Jefferson T, Rivetti A, Rivetti D. Vaccines for preventing influenza in healthy adults (Review). Cochrane collaboration. The Cochrane Library, Issue 2. Available online at: http://www.cochrane.org/reviews/en/ab001269.html [accessed September 11, 2009]. Competing interests: None declared |
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Dr Viera Scheibner, Scientist (Retired)/Author Blackheath NSW Australia
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Mark McConnell’s wise young daughter recognises that there is no swine flu pandemic just as there was no, and was not going to be, any SARS or bird flu epidemic. The wise only see an attempt (doomed right from the onset) to CREATE an epidemic. Once again, the babe recognised that the emperor is naked. Para-phrasing a past US presidential campaign: “there is no emerging swine flu pandemic, it’s the $$$economy stupid”, and what would Shakespeare say? Much ado about nothing. Competing interests: None declared |
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Peter J Flegg, Consultant Physician Blackpool, UK FY3 8NR
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I thank Peter Collignon for providing links to the data regarding the Australian wave of the pandemic H1N1 flu. The arguments for mass vaccination may well be different for Australia where they are emerging from the usual seasonal risk period, but in the Northern hemisphere it is prudent to plan for a second wave in winter and it is sensible to ensure that all vulnerable groups are offered the potential protection of a vaccine when this is available and has completed its safety and efficacy checks. The recent BMJ article on lessons learned from Australia was instructive; apart from the opinion voiced by Dr Collignon criticising the overall response as being excessive there were other senior clinicians who "believe the risks [of H1N1] are understated" and who indicate the demands for critical care services in the Northern hemisphere are likely to be overwhelming. It must be remembered that in this scenario it is not just the deaths from influenza that may be "due to flu", but the deaths of all those without flu who will be unable to access level 2/3 critical care can also be indirectly attributed as deaths "due to flu". With H1N1 certain groups are more at risk of death and complications than others, and these groups should be prioritised for vaccination to minimise the chance that they get infected and require admission/critical care. I must question some of Dr Collignon's own figures, however. He tells us H1N1 has "a very low mortality rate (less than 1 per 10,000 infected)" but the references he cites as evidence for this for this clearly indicate there have been 150 deaths out of 34,172 cases. That makes a mortality rate of 1 per 228 infected by my calculations. The reference cited also states the number of notified flu deaths is an underestimate. Even accounting for some underdiagnosis of mild disease increasing the denominator, it is hard to know how he derives his estimate. If true it would suggest that nearly one in ten Australians have already had H1N1 without realising it. Dr Collignon is correct that fear pushes us to do things which may not be appropriate, such as the overuse of oseltamivir. Yet there seems to have been little in the way of clinical harm as a result of its use (side effects, though frequent, were mostly mild/tolerable and less severe than the flu) and fears of widespread resistance have proved to be unfounded (only 18 cases have been reported worldwide). Yet concerns about use/misuse of antivirals should not be used as a reason to deny protection from H1N1 to those who need it the most. Competing interests: None declared |
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Dr.Nadaraja Bathirunathan, Retired Lecturer Clinical Sciences, MRI,M14 9PL
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There cannot be any doubt that the new H1N1 virus is highly contagious but only produces mild disease, probably is even less virulent than seasonal flu. Dr.Scheibner has put it very succinctly 'Much ado about nothing'. I have recently returned from India and what struck me was the valuable resources diverted by the officials into the anti-flu campaign, which at that time had reported only a single case of H1N1 flu in an Airline passenger who had mild fever lasting for a day. Thousands of casualties to preventable diseases like diarrhoea, malaria an tuberculosis are a daily occurrence there. Peter Collignon referred to the inappropriate fear which has pushed us to inappropriate responses. May I refer to inappropriate information which has been used to create unnecessary fear both by the WHO and the UK swine flu information leaflet: because it is a new virus no one will have immunity to it (1,2). H1N1 has been around since 1918. This is a new variant, a fact that I don't argue. But is it true that no one will have immunity to it? Millions have been infected. Most patients had only mild symptoms. The death rate and overall admission rate were the same or even lower than for seasonal flu. How could this have happened if the infected population did not have any immunity? In fact they had good immunity. Two distinct immune systems operate in our body:innate immunity and acquired immunity. Innate immunity is a primitive but powerful immune system that comes into operation immediately after infection and does not require previous exposure to the invading microbe. Pattern recognition receptors in the host cell recognise pathogen associated molecular patterns in a general manner and signal the immune system to destroy the parasite. There are also thousands of antimicrobial peptides which keep the pathogen in check. Acquired immunity operates by lymphocytes which specifically recognise antigenic epitopes in the pathogen. Quite a large percentage of these epitopes will be shared by the different flu viruses and the vaccines already in use. In fact most of us have good immunity to the new H1N1 virus as demonstrated by the epidemiology of the present Pandemic. 1.World Health Organization. Ten things you need to know about pandemic influenza. 2005. 2.Important Information about Swine Flu. www.direct.gov.uk/swineflu Competing interests: None declared. |
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Victoria C Bingham, Writer Researcher Alexandria VA 22312
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Dear Mr. Doshi, This is the second of your articles that I have had the happy opportunity to read, the first being - ‘Are Flu Death Figuress More PR than Science?”. For 10 years now I have read (and practiced what I've learned, i.e. eschewing vaccinations altogether) - voraciously on the subject of vaccines. I found yours - in the above referenced article - to be a long overdue common sense voice, in contrast to the CDC’s unfathomable style of reporting flu deaths, and the hysteria that is clearly (to some of us) tacked on to the subject and racheted up systematically every few years or so. Lately I have been searching the CDC web site to get their figures on just how many people they are alleging to have died this year from H1N1 in the US (I say 'alleging' since actual testing for this specific ailment stopped late summer) and how it compares to their mantra of ’36.000 flu deaths annually' for ‘seasonal flu’. It would appear to me that if you 'do the math', that providing the reported figures for H1N1 deaths is accurate, that no one has had the regular flu at all. Getting an actual tally from the CDC web site though I discovered, is as easy as finding Osama Bin Laden since 1997. I do have a question that I would like to ask you. Are there any reliable statistics for the number of flu deaths (in any age group or any nation) relative to the percentage of these victims having been innoculated, or not? Any feedback is welcome. I’m obliged in advance. Victoria Christine Bingham Alexandria VA EMAIL: artistry@bfresco.com Competing interests: None declared |
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