Margaret McCartney: What use is mass flu vaccination?
BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6182 (Published 20 October 2014) Cite this as: BMJ 2014;349:g6182All rapid responses
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I have just retired after 26 very happy years as a full time GP. While working, I guess we tolerate some of the nonsense as a survival mechanism. Margaret McCartneys piece this week on the bizarre annual ritual of flu jabs is a case in point. What is even more bizarre is to ignore the massive evidence base for activity as a solution to our crumbling NHS. At a population level, it is an independent risk factor separate from and having much greater impact than obesity (1).
27 million adults (63%) in this country are not taking enough exercise to affect their morbidity and mortality (2) which in blunt terms means they are shortening their lives by 4.5 years (3). This lack of activity is one of the factors adding to the precious commodity of disease-free life, which the richest in our society have 17 years more of than our poorest (4).
We need to reverse our thinking and allow people to make positive choices by creating the infrastructure that gives people the ability, particularly our most deprived, to cycle and walk easily. £10 per head of the population would be a good start and has been endorsed in principle by the Undersecretary of State for Transport (5) . His goal is for 2020 but that is a lot of morbidity and misery, not to mention unnecessary expense for the NHS, in the meantime. Holland has been doing this for 40 years. Their figure for those not taking sufficient activity to benefit health is 18%.
This money should come largely from CCGs and Acute Trusts as they will reap the benefit. We should stop pouring money into conditions such as Type 2 Diabetes (medicalised obesity), which is merely a licence for pharma to print money. The benefits for improvement in morbidity exist right across the board (6).
Dr Ewan Hamnett
Lead for Physical Activity and Wellbeing, Birmingham City Council
1. Steven N. Blair, Physical Inactivity: The Biggest Public Health Problem of the 21st Century, Br J Sports Med, 2009;43:1-2
2. Active People Survey, Public Health Outcomes Framework Indicator, Department of Health and Sport England, 2013;2.13i & 2.13 ii
3. Steven C. Moore, Leisure Time Physical Activity of Moderate to Vigorous Intensity and Mortality: A Large Pooled Cohort Analysis, PLOS Medicine, November 2012;Volume 9 Issue 11
4. Making the Case for Public Health Interventions, Kings fund and Local Government Association, September 2014
5. Richard Goodwill, Undersecretary of State for Transport, Parliamentary debate on cycling, 16/10/14
6. Lets Get Moving-Commissioning Guide, 2012, www.dh.gov.uk/publications
Competing interests: No competing interests
Oh dear - more column inches granted to those who appear to want to dismiss the benefits of vaccination without considering all the information available. Trivialising the severity of influenza as a disease (transmitted by aerosol - for the benefit of an earlier contributor who does not believe it is a disease) which kills people every year in the UK and asserting that vaccination is useless is perhaps an indicator that last year's data from CDC has not been read by Margaret McCartney. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6307a1.htm
If she took the trouble to investigate this, then the 62% (CI 52-68%) protection afforded by last year's vaccine would be evidence that perhaps it is worth being vaccinated after all. Although not every vaccine has the same protective ability, they are produced with what are thought to be the most likely circulating starins for the coming season.
For those who wish to obtain more information about flu vaccination and its benefits there are other good resources on the CDC webpage of which the following links are two:
http://www.cdc.gov/flu/pdf/freeresources/general/flu-vaccine-benefits.pdf
http://www.cdc.gov/flu/about/qa/vaccineeffect.htm
Thanks,
Chris Settle
Competing interests: No competing interests
It has for a long time concerned me that we are not routinely giving full information to assist patients in giving informed consent for flu vaccine.
This should in my opinion include a statement about the doubts about efficacy as in Margaret McCartney's review but also should highlight the potential for side effects - flu like illness and feeling unwell - common, but also rare but serious side effects Guillain Barrie Syndrome to name just one. There should also be a conflicting interests statement that highlights the pressures financial and otherwise that Doctors are under to hit targets of flu vaccine coverage and that therefore the advice to have flu vaccination may be subject to bias.
Do the incentives in the Flu Fighter campaign accord with the notion of "freely given consent without duress"? I doubt it
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I dont even consider flu as an infectious disease and so if this is so then a vaccine is totally useless. The theory that flu is infectious is seriously flawed because there is no mode of transmission. I have just put together a small article on Rochdale Online on the badger cull and it is called 'TB Not Infectious' and so we can easily make a comparisons to that article because TB isn't infectious either. There is no mode of transmission either in animals or humans. What we do is translate a test result into infectious disease or we assume infection based on the theory of infectious germ but this is all theory and hearsay.
John Wantling, Rochdale, UK Badger Cull - TB not Infectious
http://www.rochdaleonline.co.uk/news-features/129/letters-to-the-editor/...
Competing interests: No competing interests
Serious doubt about the safety and effectiveness of flu vaccine has a long history: Sir Macfarlane Burnet, 1960 Nobel laureate, made seminal contributions to our knowledge of influenza viruses; he once observed, "A vaccine is available but reduces the risk of catching flu only by half. This hardly measures up to our expectations for a modern vaccine. Furthermore,the remarkable propensity of influenza to undergo antigenic drift ensures that in any major new pandemic the virus will be one step ahead of the manufacturers." (1972, 'Natural History of Infectious Disease')
Anthony Morris was chief vaccine officer for the U.S. Bureau of Biologic Standards and the FDA. His unit's research yielded evidence that flu shots were ineffective, and he criticized the government for basing mass vaccination programs on claims made by the manufacturers. In 1980, after over 30 years of service and as part of the fallout from the "swine flu fiasco," he was forced into early retirement. ('Washington Post' obituary, 7/3/14)
Kenneth McIntosh counselled against routine flu vaccination of children because we lacked information about long-term risks and benefits; his advice was ignored in the U.S. (NEJM 342: 275, 2000)
Lone Simonsen found that from 1968 to 2001 U.S. flu deaths in the elderly increased in concert with their increasing use of flu vaccine. (Arch Int Med 165:265, 2005. Science 307:1026, 2005) She and other experts suggested that the evidence of protection from observational studies resulted from "healthy-user bias" and that widely publicized claims for large numbers of deaths prevented by vaccine were completely implausible.
Tom Jefferson, Peter Doshi and their colleagues at the Cochrane Collaboration published several reviews spotlighting the absence of high-quality evidence for flu vaccine's safety or effectiveness. (BMJ, Lancet, Cochrane Reviews, 2004-2014)
Rogier Bodewes has referred to the "double-edged sword" of annual vaccination because it subverts broad and lasting natural immunity. (Lancet Inf Dis 9:784, 2009. J Virol 85:11995, 2011)
Michael Osterholm and his CIDRAP colleagues completed a massive review of flu vaccines. Like Jefferson and colleagues they also found that the quality of the evidence was poor and that the vaccines are not very effective. (CIDRAP News 10/25/11. Lancet Inf Dis 12:36, 2012) Their public statements, however, have not been nearly as blunt as Jefferson's.
A few clinician-scientists cherish pious hopes for a broad, unbiased trial that will settle where, in the long run, the balance truly lies between the harms and benefits of annual vaccination. This will never happen; our best hope is for the development of a safe and effective universal vaccine that can be given once or twice or three times in the course of our lives. Not long ago I asked a Canadian flu expert about the feasibility for such a vaccine. She thought it was scientifically feasible, but she doubted that the manufacturers would willingly give up the guaranteed annual income of seasonal vaccines. Meanwhile the Massachusetts Nurses Association is suing Brigham and Woman's Hospital to block a mandate requiring annual flu shots as a condition for employment, citing state law, limited vaccine effectiveness and adverse effects. ('Boston Globe' 9/25 & 9/29/14)
Competing interests: No competing interests
Mass flu vaccination is not only useless, as Margaret McCartney suggests; it may do real harm, opportunity cost aside.
Flu vaccine can actually increase the risk of illness from influenza viruses. (Skowronski, PLoS Med 7(4):e1000258, 2010. Emborg, BMJ 344:d7901,2012. Cowling, CID 51:1370, 2010. Skowronski, CID 52:831, 2011. Crum-Cianfone, CID 49:1801, 2009. Iuliano, CID 49:1811, 2009. King, NEJM 355:2523, 2006. Thomas, Ped IDJ 22:201, 2003). There are at least three plausible mechanisms that explain why vaccination can increase risk: 1. It blocks the development of robust, complex and cross-protective immunity from active infection; 2. It commits the immune system to the vaccine strain and prevents an optimal response to a wild virus that may be only slightly different antigenically ("original antigenic sin").; 3. OAS is related to "antibody-dependent enhancement" whereby vaccine-induced antibody attaches to a wild virus but fails to neutralize it; instead the antibody actually fosters virus entry into cells and viral replication.
Flu vaccine also increases the risk of illness from other respiratory viruses. (Cowling, CID 54:1778, 2012. Kelly, PedIDJ 30:107, 2011). This may result from non-specific immune suppression or by aborting the "virus Interference" whereby cytokines evoked by one active infection repel subsequent invasion by other viruses.
One or more of the foregoing immune mechanisms may relate to recent observations that repeated vaccination progressively attenuates the modest protection sometimes afforded by seasonal flu vaccine. (Ohmit, CID 56:1363, 2013. Ohmit, CID 58:319, 2014. McLean CID online 9/29/14).
Competing interests: No competing interests
Cost Effective Mass Flu Vaccination is Useful in Children
Flu vaccination may not be useful in elders but it is useful in children. Flu vaccination may reduce the incidence of flu more than 80% with near total prevention of death due to flu in children. So cost effective mass flu vaccination is very useful in children.
Competing interests: No competing interests
In her article for BMJ titled “What use is mass flu vaccination?”, Dr. Margaret McCartney asks “why are we vaccinating so many people in whom we have no proof that it works?” Systematic reviews of influenza vaccine clinical trials have highlighted that few randomized controlled clinical studies with currently available vaccines have been conducted in adults, however estimates of vaccine efficacy in adults by these systematic reviews have differed (1-4). Some have included as negative studies those that were underpowered. Others have not included more recent trials that have been carried out for the purpose of licensure (5, 6).
In the article, McCartney conflates limited randomized clinical trial data with lack of data. It also assumes that valuable data can only come from clinical trials, which require considerable resources to conduct. With the current positive data on vaccine efficacy in younger individuals (1, 3, 7), many feel that a placebo-controlled trial in the elderly would be unethical. Well-designed, observational studies confirm influenza vaccine effectiveness in adults against influenza virus infection in the community as well as against more severe influenza disease (8, 9), however vaccine effectiveness depends on many factors including the population understudy, the degree of match between vaccine and circulating viruses, and the study endpoint chosen.
Fewer influenza vaccine clinical trials have been conducted in the elderly, and available data indicate that vaccine effectiveness is likely lower in this group than among healthy adults. More effective vaccines for elderly populations are clearly needed, and it is encouraging that research is ongoing (5). However, the high rates of influenza-associated hospitalizations and mortality in adults and elderly populations justifies the use of influenza vaccines (even if only moderately effective) to reduce this large burden of disease (10, 11).
References
1. Breteler JK, Tam JS, Jit M, Ket JC, De Boer MR. Efficacy and effectiveness of seasonal and pandemic A (H1N1) 2009 influenza vaccines in low and middle income countries: a systematic review and meta-analysis. Vaccine. 2013;31(45):5168-77.
2. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. The Cochrane database of systematic reviews. 2014;3:CD001269.
3. Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. The Lancet Infectious diseases. 2012;12(1):36-44.
4. Darvishian M, Gefenaite G, Turner RM, Pechlivanoglou P, Van der Hoek W, Van den Heuvel ER, et al. After adjusting for bias in meta-analysis seasonal influenza vaccine remains effective in community-dwelling elderly. Journal of clinical epidemiology. 2014;67(7):734-44.
5. DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. The New England journal of medicine. 2014;371(7):635-45.
6. Jain VK, Rivera L, Zaman K, Espos RA, Jr., Sirivichayakul C, Quiambao BP, et al. Vaccine for prevention of mild and moderate-to-severe influenza in children. The New England journal of medicine. 2013;369(26):2481-91.
7. Jefferson T, Rivetti A, Di Pietrantonj C, Demicheli V, Ferroni E. Vaccines for preventing influenza in healthy children. The Cochrane database of systematic reviews. 2012;8:CD004879.
8. McNeil S, Shinde V, Andrew M, Hatchette T, Leblanc J, Ambrose A, et al. Interim estimates of 2013/14 influenza clinical severity and vaccine effectiveness in the prevention of laboratory-confirmed influenza-related hospitalisation, Canada, February 2014. Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin. 2014;19(9).
9. Thompson MG, Sokolow LZ, Almendares O, Openo K, Farley MM, Meek J, et al. Effectiveness of nonadjuvanted monovalent influenza A(H1N1)pdm09 vaccines for preventing reverse transcription polymerase chain reaction-confirmed pandemic influenza hospitalizations: case-control study of children and adults at 10 US influenza surveillance network sites. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2013;57(11):1587-92.
10. Zhou H, Thompson WW, Viboud CG, Ringholz CM, Cheng P-Y, Steiner C, et al. Hospitalizations Associated With Influenza and Respiratory Syncytial Virus in the United States, 1993–2008. Clinical Infectious Diseases. 2012;54(10):1427-36.
11. Centers for Disease Control and Prevention. Estimates of deaths associated with seasonal influenza --- United States, 1976-2007. MMWR Morbidity and mortality weekly report. 2010;59(33):1057-62.
Competing interests: No competing interests
This is more of a "mass" movement rather than evidence based medicine. It does not hold promise on practical bases either due to a whole lot of "ifs" in it.
Competing interests: No competing interests
Re: Margaret McCartney: What use is mass flu vaccination?
Thank goodness for common sense. For over thirty years I was a reluctant participant in this cruel unnecessary ineffective campaign. I was made to feel ignorant for refusing to be personally vaccinated and for advising my mother, now 92, to refuse vaccination.
I believed and am pleased Margaret McCartney agrees that only people with chronic diseases such as diabetes and COPD were likely to benefit. I hope this article receives nationwide media attention and the pointless waste of time and money is discontinued.
Competing interests: No competing interests