A jab in the dark
BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e5313 (Published 08 August 2012) Cite this as: BMJ 2012;345:e5313All rapid responses
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Nigel Hawkes also ought to be interested in the apparently spurious figure of 20,000 annual influenza deaths which he quotes in good faith. Challenged in these columns by Tony Delamothe in December 2009 to give influenza mortality figures for the previous four years Liam Donaldson (at the time Chief Medical Officer) et al posted a Rapid Response one chilly Christmas Eve acknowledging only 131 registered deaths in the entire period (about 33 a year!) [1].
The official estimates of flu deaths on the other hand were projected purely on the basis of excess winter mortality. In other words in those years (roughly half) where mortality was above average the deaths were attributed entirely to flu, whereas in those years where it was below average deaths were projected as zero.
So, where does the 20,000 flu deaths come from? I am just guessing but according to Donaldson the worst recent winter was 1999-2000 with 21,497 deaths, but this was based on the above average winter mortality figures. In other words, if this was the basis of the figure, they were not flu deaths at all - just deaths and it was an exceptionally bad year.
Perhaps Prof Hall could elucidate?
[1] Liam J Donaldson et al, 'Author's response' BMJ Rapid Responses 24 December 2009, http://www.bmj.com/rapid-response/2011/11/02/authors-response-17
Competing interests: Autistic son
Nigel Hawkes raises some interesting questions in relation to both the proposed nasal spray influenza vaccination for school children as well as the lack of transparency and accountability of the Joint Committee on Vaccination and Immunisation. But there are some further issues he might like to look into.
For instance, the manufacturer's product information for Fluenz states [1]:
"FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
"Do not administer FLUENZ to infants and toddlers younger than 12 months. In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8).
"It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age. In a clinical study, an increased rate of wheezing was observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8).
"Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone
marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of
transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus."
So, in other words, the project will inevitably put at risk a great many people who cannot "benefit" directly from the vaccine including students with asthma or lowered immunity as well as infants and elderly and sick people at home, which is made doubly absurd by the poor history of anticipating the right virus strains [2] thus exposing the population en masse to an illness they most like would not otherwise have encountered. The wisdom and ethics of the committee in doing this is certainly open to question.
Secondly, the JCVI has a long and troubling history over safety issues over which it has yet to answer. In a presentation last year to the British Society of Ecological Medicine Dr Lucija Tomljenovic of British Columbia University drew shocking attention to the problem [3]:
"Here I present the documentation which appears to show that the JCVI made continuous efforts to withhold critical data on severe adverse reactions and contraindications to vaccinations to both parents and health practitioners in order to reach overall vaccination rates which they deemed were necessary for “herd immunity”, a concept which with regards to vaccination, and contrary toprevalent beliefs, does not rest on solid scientific evidence as will be explained. As a result of such vaccination policy promoted by the JCVI and the DH, many children have been vaccinated without their parents being disclosed the critical information about demonstrated risks of serious adverse reactions, one that the JCVI appeared to have been fully aware of. It would also appear that, by withholding this information, the JCVI/DH neglected the right of individuals to make an informed consent concerning vaccination. By doing so, the JCVI/DH may have violated not only InternationalGuidelines for Medical Ethics (i.e., Helsinki Declaration and the International Code of Medical Ethics) [2] but also, their own Code of Practice(http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf).
But perhaps most disturbingly of all, given the unconciliatory attitude of Professor Andrew Hall, the committee's chairman below [4], the JCVI - according to a remarkable government edict of 2009 - is no longer answerable to the government but vica versa, placing an "Obligation on the Secretary of State to ensure implementation of JCVI recommendations" [5]. While it remains constitutionally dubious whether parliament can abrogate its authority in such a way the continuing prostration of government before this body deserves public scrutiny and scepticism.
[1] http://ec.europa.eu/health/documents/community-register/2011/20110127931...
[2] Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E, 'Vaccines for preventing influenza in healthy adults.', Cochrane Database Syst Rev. 2010 Jul 7;(7):CD001269.
[3] Dr Lucija Tomljenovic, 'The vaccination policy and code of ethics of the Joint Committee on Vaccination and Immunisation: are they at odds?' BSEM March 2011 http://www.ecomed.org.uk/wp-content/uploads/2011/09/3-tomljenovic.pdf
[4] Andrew J Hall 'Re: A Jab in the Dark', BMJ Rapid Responses 22 August 2012 http://www.bmj.com/content/345/bmj.e5313/rr/599198
[5] The Health Protection (Vaccination) Regulations 2009, http://www.legislation.gov.uk/uksi/2009/38/contents/made
Competing interests: Autistic son
The JCVI states that a key reason for not making public all the evidence it uses in making its decisions is that making evidence public would lead to scientists refusing to send their work to the committee before it was published in a peer-reviewed journal and this might then lead to adverse outcomes.[1] Can the JCVI give some examples of where the use of unpublished evidence by the JCVI has resulted in decisions that have led to improved health outcomes or reduced mortality? Can they also supply evidence that academics would refuse to submit unpublished evidence if they knew this would be made public?
The JCVI also states that the processes the committee uses are "at least as robust as those of scientific journals”. However, the peer-review processes used by journals are flawed, errors in journal articles are common, and many factual errors and methodological problems are often not detected until after publication of an article.[2] Can the JCVI expand on how it aims to address these issues in the unpublished evidence it receives?
I would expect the JCVI to have substantially more rigorous procedures for peer review than scientific journals because the decisions the committee reaches have major implications for public health, health outcomes, and health care spending. There is a degree of subjectivity in how decisions on immunisation policy are reached. For example, chickenpox (Varicella) vaccination in children is part of the immunisation schedule in the USA but not in the UK.[3] Hence, immunisation committees in different countries can look at the same evidence but sometimes reach very different conclusions about immunisation policy. Public policy making is not an exact science but should as far as possible be based on robust, publicly available evidence that can be fully assessed by external stakeholders.
1.http://www.bmj.com/content/345/bmj.e5313?tab=responses
2. Majeed A. How should medical journals deal with errors? JRSM 2012;105:51-52.
3. Centers for Disease Control and Prevention. Child, Adolescent & "Catch-up" Immunization Schedules. http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html
Conflict of interest: As an academic primary care physician, I am strongly supportive of evidence-based immunisation programmes.
Competing interests: No competing interests
Response to Nigel Hawkes “A jab in the dark”
Mr Hawkes proposes that the evidence on which JCVI bases its decisions should be simultaneously placed on a website. He also suggests that not to do so can only be due to academic vanity. However academics are now judged and rewarded on the basis of their publications in peer reviewed journals with high impact. So this goes beyond vanity. If JCVI were to do as is suggested then we would rapidly have few scientists willing to subject their evidence to the committee pre-publication. The alternatives of waiting for publication before making a decision or not considering unpublished evidence either make for bad decisions or cost lives through delays in implementing cost effective vaccinations.
The crucial pieces of unpublished evidence that influence JCVI decisions are all subject to peer review and response prior to coming to the committee. In addition the committee requires full declarations of conflict of interest from the scientists involved. Processes that are at least as robust as those of scientific journals.
Mr Hawkes also makes assumptions based on the evidence that he has not seen that the JCVI decision was based solely on herd immunity resulting from vaccination of the children and adolescents. This is incorrect. The evidence showed that direct protection was cost effective.
It is notable that inaccurate, irresponsible journalism has been the major cause of under-performing vaccination in the UK over the last 50 years (measles and autism, DPT and encephalopathy) with resultant deaths.
Andrew J Hall
Chairman, JCVI
Competing interests: I chair the committee that the comment critics
Re: A jab in the dark
[Corrected version of my Rapid Response dated 26 August 2012]
Nigel Hawkes also ought to be interested in the apparently spurious figure regarding annual influenza deaths which he quotes in good faith. If two thousand fewer flu deaths represents a 40% reduction, then the JCVI seem to be projecting an annual death rate of 5,000. Challenged in these columns by Tony Delamothe in December 2009 to give influenza mortality figures for the previous four years Liam Donaldson (at the time Chief Medical Officer) et al posted a Rapid Response one chilly Christmas Eve acknowledging only 131 registered deaths in the entire period (about 33 a year!) [1].
The official estimates of flu deaths (Health Protection Agency) on the other hand were projected purely on the basis of excess winter mortality. In other words in those years (roughly half) where mortality was above average the deaths were attributed entirely to flu, whereas in those years where it was below average deaths were projected as zero.
As an observation if you took the years when deaths were above average and the years when they were below average and averaged them out (instead of ignoring the low years) the result would be actually zero.
So where does the 5,000 deaths come from? Perhaps Prof Hall can elucidate.
[1] Liam J Donaldson et al, 'Author's response' BMJ Rapid Responses 24 December 2009, http://www.bmj.com/rapid-response/2011/11/02/authors-response-17
Competing interests: No competing interests