Influenza vaccination: policy versus evidence
BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38995.531701.80 (Published 26 October 2006) Cite this as: BMJ 2006;333:912
All rapid responses
In his 28 October review of the available literature, Tom Jefferson
finds that there is a "large gap between [influenza vaccination]
policy and what the data tell us."[1] What the
data tell us, he writes, is that the inactivated vaccines have
"little or no effect on the effects measured" and the comparative
evidence is insufficient to demonstrate the vaccines are safe.
Jefferson's results are consistent with previous epidemiological
reviews of the effects of influenza vaccination. A 2005 National
Institutes of Health review of over 30 influenza seasons "could not
correlate increasing vaccination coverage after 1980 with declining
mortality rates in any age group" and concluded "observational
studies substantially overestimate vaccination benefit." [2]
Annually, public health agencies in the US and UK launch massive
campaigns aimed at convincing doctors of the importance of influenza
vaccination. Is this necessary? Safe and effective interventions
for diseases that truly pose a threat to morbidity and/or mortality
are unlikely to be controversial. It is interesting to note here
that not only is the evidence supporting the safety and effectiveness
of influenza vaccination lacking, but there are also reasons to
doubt conventional estimates of the mortality burden of influenza.
As I have documented previously, [3] the mortality
data is a mess--over the period in which CDC statistical modeling
of flu-associated mortality has estimated an 80% rise in deaths,
officially recorded flu deaths have dropped 30%. Complicating this
is the fact that influenza-like illness is not only indistinguishable
from influenza, but far more common, leading to unrealistic
expectations of influenza vaccination.
The policy questions raised by these reviews are crucial to answer.
While it is often said that influenza poses a serious burden to
health, influenza vaccines impose their own particular burden--to
the tune of billions of dollars annually. If policy is going to
be driven by evidence, this requires us, first of all, to consider
the evidence.
References:
- Jefferson T. Influenza vaccination: policy versus evidence. BMJ 2006;333:912-915. (also online)
- Simonsen L, Reichert TA, Viboud C, Blackwelder WC, Taylor RJ, Miller MA. Impact of Influenza Vaccination on Seasonal Mortality in the US Elderly Population. Arch Intern Med 2005;165(3):265-272. (also online)
- Doshi P. Are US flu death figures more PR than science? BMJ 2005;331:1412. (also online)
Competing interests:
None declared
Competing interests: No competing interests
5 years ago I asked my GP what the facts were about the pros and cons
of ‘flu vaccination, and I was referred to the propaganda hand outs from
the Department of Health. These were long on assertion and short on facts.
Perhaps unwisely I embarked on a literature search and running
correspondence with various civil service mandarins (including Sir Liam
Donaldson) with the limited ambition of getting data on what actual tests-
of efficacy and safety- were done on current vaccines and with what
results. After much evasive action and stalling I was informed that such
information was confidential.
The Lancet (2001:357:2141) published my scepticism about the extra
ordinary claims being made for the ability of ‘flu vaccine to prevent not
only the ‘flu but death as well, whatever the cause. Since then there have
been a few papers expressing concern about the inconclusive nature of the
evidence for its efficacy (1,2). On the other hand, there have been
repeated exhortations to the public to “protect themselves.” The enormous
expense of this futile exercise doesn’t seem to register- partly, I fear,
because of payment inducements offered to GPs. They, perhaps, may claim
they believed the recommendations of the DH and carried out the
vaccination programs in good faith. This “only carrying out orders” excuse
is of doubtful validity. There can be no excuse for the harmful public
health decisions and refusal to come clean about what precisely were the
reasons for their them.
It is too much to hope for repentance and reversal, however. The Faustean
contract exemplified in the structure of the Medicines and healthcare
products regulatory agency will see to that.
1.van der Wouden et al, Respiratory Medicine (2005) 99,1341-1349.
2. Simonsen L et al, Arch Int Med (2005) 165, 265-272
Competing interests:
None declared
Competing interests: No competing interests
Over the past few decades the practice of Medicine has moved from a
basis of personal experience and understanding of the disease process and
its treatment, towards the application of authorized protocols and
guidelines. The body of Medical knowledge is now so great that this has
many advantages. Nevertheless, we do recognize the importance of in-depth
understanding, both in applying guidelines sensibly, and managing uncommon
conditions for which rigorous evidence-based recommendations are not
available.
Tom Jefferson's article raises concern about the situation in which
an inadequate evidence base has become canonised into established
guidelines, Government policy and incentivised practice. It takes a bold
man indeed to challenge this set of Emperor's clothes.
Perhaps we need a forum within which such nagging concerns can be
raised by lesser mortals in order to build up a sufficient groundswell of
opinion to challenge the court tailors.
Competing interests:
None declared
Competing interests: No competing interests
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Influenza vaccination: what evidence can we rely on?
Dear Editor,
I concur largely with the sentiments in this paper. However, I have a
question regarding why we are still in the position of needing such a
paper and three minor points on the paper itself. Fundamentally,the author
questions the value of a number of studies in terms of the quality of
their study design. At least two of these were published in the last two
years in reputable journals. Is it reasonable to ask why are poor quality
studies still being funded and published, despite the efforts of this
journal and others to improve standards. I agree the cost effectiveness of
the influenza vaccination campaign is of vital importance but so is the
cost effectivenss of basic research. At the very least, we should be able
to rely on studies to do "what they say on the tin" - even varnish does
that!
Three more minor points. Is this article a personal interpretation of the
evidence or does it have the weight of the Cochrane Collaboration behind
it? Secondly, on the point of bias in cohort studies it would have been
helpful to state whether in fact the cohorts were different (either from
studying the papers or by questioning the authors directly) rather than a
statement that seems like speculation - "In this case, the vaccinated hemi
-cohort MAY have been nore mobile, healthy etc..." I do not have the time
to look at original papers and rely on reviews such as this to provide me
with the appropriate information. As the author indicates, such
information is key to interpreting the reliabiltiy of the study
conclusions. Clearly the question of whether the cohorts were comparable
is key. Thirdly, there doesn't appear to be any specific reference to the
work of the General Practice Research Unit in Birmingham which collects
lots of data on flu from general practice. If this data does not provide a
useful contribuiton to this issue is it worth collecting?
Competing interests:
None declared
Competing interests: No competing interests