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The Wannabee
Foundation
D R
MARK
DONOHOE
MB BS
Further to my letter to the MJA, and your response, I am
submitting the following for inclusion as an extended editorial or
opinion piece in the MJA.
I was not willing to comply with your request for a
letter restricted to the specific issue of reporting rates for
immunisation adverse reactions. The issue is complex, and I believe that
it is the author's prerogative as to the content of a submission, just
as it is the Journal's prerogative to accept or reject such submissions.
I believe these are important issues, and are not
helpful or useful if dealt with superficially, as would be required for
such a letter. Honesty in reporting of statistics, accuracy in data
collection, real versus perceived immunisation rates, and a means of
bringing the community together on this issue are major issues, brought
sharply into focus in this current debate. As doctors, we must face our
profession's shortcomings if we are to develop better systems and learn
from past errors.
If you are unwilling to use the article, I would
appreciate your earliest possible notice. I have another publication
outlet available, and would use this article as it stands while the
issue remains relevant and important to doctors.
Length of contribution - 3,200 words
Signed,
Dr Mark Donohoe MB BS
Immunisation - Lessons from the current debate
Dr Mark Donohoe MB BS
I. Introduction
The immunisation debate is a necessary and important
factor in Australia reaching an appropriate level of vaccination. It
has, however, become an emotional issue in recent months, leading some
authors to go so far as to promote tactics to enforce immunisation on
those who have made an informed choice not to vaccinate
1.
This debate, therefore, is important for reasons which
extend beyond the risks and benefits of immunisation. It is a debate
which tests our ability to discuss important and controversial issues
openly, which tests medicine's ability to maintain an objective and
scientifically supported stand, which tests doctors ability to fully
inform their patients of risks as well as benefits, and tests our
profession's honesty in reporting adverse outcomes from vaccine
preventable illness and immunisation adverse reactions.
It also tests our ability as a society to accept the
informed decisions of those who choose to hold a contrary viewpoint
without prejudice or vilification.
I wish to state my own position on the subject up front.
I am in no way 'anti-vaccination' or 'pro-vaccination'. These labels are
media constructs, and do a disservice to any thinking person in issues
as complex as this. My personal belief is that the informed decisions of
an educated public and profession lead to the best choices in medical
care. Whether a person so informed decides to vaccinate or not to
vaccinate, I am of the opinion that it is not my right to interfere. In
my own practice, I have tended to see more iatrogenic problems than are
seen in most medical practices. I see many people who believe their own
or their children's health has suffered as a result of vaccination, in
which adverse effects had not been reported by their own doctors.
The debate, if it continues to be conducted at the
extremes, will worsen matters, and may lead to a fall in vaccination
rates. It is already confusing parents, who cannot determine a sensible
path from the extreme views presented.
It also risks causing alienation and vilification of
those who decide not to vaccinate. Some, including a few of my medical
colleagues, believe that this is an acceptable tactic, in that it will
apply social pressure making it difficult or impossible for parents to
choose not to vaccinate. It is a tactic which I find reprehensible and
profoundly anti-scientific, especially when the alternative is improved
education, and gaining an understanding of the reasons people oppose
vaccination.
Enforcing one's opinion, no matter how passionately held
to be true, by accusing dissenters of negligence, by stifling free
speech, by inducing social outrage and indignation, and by manipulating
and distorting statistics, are anti-scientific practices which medicine
would do well to eschew.
II. Flawed methods of assessing adverse outcomes
Immunisations cause beneficial and adverse outcomes
2,3,4,5.
To pretend otherwise demonstrates ignorance or deceit. Most adverse
reactions are self-limiting and mild, while occasional reactions are
serious and may be fatal. That there are major benefits to be gained by
the community from immunisation is, to my mind, not in doubt.
There is a problem inherent to defining potential
adverse reactions to procedures such as immunisation. As doctors, we are
dependent upon the medical literature and adverse reactions registers to
identify cases where poor outcomes could be attributed to the procedure.
This causes something of a dilemma, as can be seen in the recent
Coroners Case.
A child died about three hours after being vaccinated
from sudden infant death syndrome.
The coroner looked to the medical literature to see if
such reactions were reported, and to see if evidence exists to support a
causal link. Finding no proven association, he determined that there was
unlikely to be any association in this case.
This particular case is then lost from the literature as
a potential
adverse reaction, and is not recorded in adverse reaction registers. If
the same problem was seen by a thousand coroners around the world in the
course of a year, and all went through the same rigorous process, they
would all come to the same conclusion. None of the cases would be likely
to enter the medical literature or adverse reactions registers,
perpetuating the view that such reactions do not occur.
The additional, more subtle problem is that the
community may hold a different view regarding these associations, so
that children identified at risk of a medical condition (such as infant
death syndrome) may remain unvaccinated because the parents fear an
adverse outcome. Thus, a pool of children 'at risk' for other illnesses
are removed from the vaccination pool, skewing the statistics regarding
any association. This type of confounding leads to a potentially serious
underestimation of the likelihood of a real association, and may even
lead to the paradoxical result that vaccination 'protects' against such
unrelated illness 6.
The problem here is that we have no method of holding
'possible but unlikely' adverse reactions in such a way that they are
available worldwide to the profession for further review. One fear is
that such information may be misused by anti-vaccination groups to
perpetuate their perceived goals, further reducing vaccination rates and
placing the community at an intolerable risk.
The view that each individual event must be decided on a
frequentist probabilistic basis, and then assigned to one of two
outcomes (ie 'adverse reaction' or 'not adverse reaction') is at odds
with current thinking on statistical approaches and inference. This 'all
or none' approach also contributes to an escalation of the bitter
disagreement between the profession and the so-called anti-vaccination
lobby, leading the latter to perceive such decisions as part of a
conspiracy to suppress information on adverse outcomes.
There is urgent need for Australia to adopt a mechanism
of reporting which captures 'possible' adverse reactions, and
accumulates them in an organised way which is reviewed regularly and
openly using Bayesian statistical methods
7,
which have been shown effective in incorporating data progressively over
time. These data would be 'out of bounds' for discussion until analyses
are completed (a process open to all interested parties), whereupon a
summarised report of findings to date would be prepared for publication
in the peer reviewed medical literature. This publication would be
regular, and independent of whether adverse reactions were found or not
(avoiding the bias of publishing positive results only).
The involvement of all interested parties, the
accumulation of experience and evidence over time, and the ability to
hold as 'undecided' information which does not fit the current
understanding of a process or illness, should all do much to improve the
quality of science, while reducing the bitterness and polarisation
surrounding the debate. Further, it would effectively separate those who
seek a better system in recording adverse outcomes from those whose
opposition to immunisation is irrational and vindictive.
III. The current epidemic
There has recently been claims in the media that
Australia is suffering a whooping cough 'epidemic'. Curiously, media
reports appear to be the only source of this information, and I could
find no data in peer reviewed medical literature to support such claims.
The Benenson definition of epidemic (kindly provided to
me by Dr Gavin Frost), appears reasonable, although it is almost
impossible to quantify.
Epidemic - the occurrence in a community or region of
cases of an illness (or an outbreak) with a frequency clearly in excess
of normal expectancy. The number of cases indicating presence of an
epidemic will vary according to the infectious agent, size and type of
population exposed, previous experience or lack of exposure to the
disease, and time or place of occurrence; epidemicity is thus relative
to usual frequency of the disease in the same area, among the specified
population, at the same season of the year.
Do the data support this definition? Are we currently
suffering an epidemic in vaccine preventable diseases?
The current national statistics on disease notification
suggest not 8.
Notifications for every vaccine preventable disease was lower in 1996
that in 1995, with the exception of diphtheria and polio (which were
zero in both years). Decreases ranged from over 60% for measles to 1%
for pertussis (whooping cough). Interestingly, only one case of
pertussis was reported in New South Wales in the December 1996 reporting
period, at the time when NSW Health was announcing the epidemic.
As well, three infant deaths have recently been
attributed to pertussis (whooping cough) in media reports. Because the
information was not released through normal medical channels, it is
impossible to determine if these deaths were due to pertussis. The US
statistics 9
suggest that in such young infants, premature birth and sickness are the
major risk factors for contracting and dying from pertussis. There is no
evidence that exposure is from unvaccinated contacts, although there is
evidence that adult hospital staff can be asymptomatic carriers of
pertussis, and would therefore be the most likely source of infection.
The point should be made that these tragic deaths were
in no way related to poor vaccination rates. Such deaths occur even
where vaccination is compulsory and complete
9.
The babies themselves were too young to have been
immunised, the infection was most likely from an adult carrier
3,
and other factors in their medical history most likely predisposed them
to a poor outcome 9.
IV. ABS 1995 Study
The 1995 Australian Bureau of Statistics immunisation
report 10
has been widely quoted as demonstrating Australia's appallingly low
immunisation rate, suggested to be 52.1%. The report suffers severe
shortcomings, most admitted in disclaimers within the body of the
report, to the extent that it is virtually useless in assessing rates or
effectiveness of immunisation in Australia. One can only assume that it
has not been read by those quoting it, including the Health Minister.
The report shows apparent improvement in immunisation
rates since 1989-1990, rather than worsening. The report does warn,
however, that the two ABS reports (1989-90 and 1995) are not comparable
because of important differences in data collection methodologies.
The report was constructed from interviews of parents
and based on their recall of immunisation. Where possible, records were
consulted to verify the parents' recollection.
Most importantly, in the 60% of interviews in which
records were consulted, the actual immunisation rate was almost twice as
high as the recalled immunisation rate.
To suggest that Australia's immunisation record is worse
than third world countries is absurd. Australia's complex immunisation
schedule (15 separate immunisations in at least 6 episodes over 5 years)
is compared to schedules in countries where a single injection is
considered evidence of immunisation. In fact, the complexity, changes
and additions to the Australian Schedule makes the 52.1% fully immunised
rate remarkable. To quote the report,
'Only those children who have
received all the vaccinations appropriate to their age for all
conditions covered by the schedule are considered fully immunised'.
Given the strict criteria, and the underestimations
admitted in the report, the fully immunised rates for individual
vaccines were surprisingly good:
Diphtheria/tetanus .68.6%
Pertussis .................59.9%
Polio.........................82.6%
Measles ...................91.6%
Mumps.....................89.6%
Rubella .....................75.5%
Hib ...........................50.2%
This accords with the findings of
Skinner
et al 11
regarding children in the northern suburbs of Sydney that,
'The full immunisation rate was 86 per cent, 14 per cent were partially
immunised and only four children had received no immunisations.'
The Minister for Health has stated, in his new
immunisation policy 12,
that he intends to raise Australia's immunisation rate to 90%. This,
from these figures, smacks of political opportunism, and could most
probably be achieved today in a properly constructed study.
Changes in the schedule in 1993 and 1994 were the main
reasons for the apparent drops in some rates. The problem was not with
the parents, but with the doctors who failed to administer the correct
vaccine at the contact. In such a case, increased effort in education of
doctors, rather than coercion of parents, would seem to be appropriate.
When the reasons for not immunising were assessed, some
very interesting results emerged.
One point of note was that the failure of the doctor to
administer the correct vaccine was not provided as an option in
answering.
Between 50% and 70% (depending on the particular
vaccine) either had not heard of the vaccine, had not got around to it,
or mistakenly thought their child was too young to have the vaccine.
Around 15% to 20% either opposed immunisation or were concerned about
side effects, and about 13% had medical reasons for failing to immunise,
or the vaccine was unavailable.
The recent political announcements (withholding of part
of the Maternity Allowance and Childcare Cash rebates)
12
do not address these problems. They
will
defer government payments,
increase popularity of a Health Minister, and cause distress and
financial hardship for all Australians, especially the poor who most
need the Maternity Allowance at the time of the birth. They also divert
attention from the current crisis in Australia's health system with a
proposal which can only further stress that system.
V. Use of the media on medical issues
In fact, this 'science-by-media-release' seems to be the
current fashion in medicine. In this case, the release of misinformation
seems to have been for 'motivational' purposes, in support of a more
general campaign to increase vaccination rates.
It would appear to be part of a deliberate process,
foreshadowed by Levy and Bridges- Webb in the Medical Journal of
Australia in 1990 (9), when they wrote,
'In order to maximize the
impact of immunisation programmes, the social and cultural contexts
within which immunisation occurs should receive greater consideration'.
The current actions would seem to be an attempt to counter what was
perceived to be successful media manipulation by the anti-immunisation
radicals. The goal of higher immunisation rates was set, and a strategy
was created to achieve the goal, irrespective of the facts. The 1995 ABS
survey was coopted into the issue, apparently without anyone actually
reading it.
The result is that trusted professors, doctors and
scientists have now descended to the level of their perceived opponents.
Truth is the victim, and unimmunised children and their parents are
being portrayed as perpetrators, a modern resurrection of a type of
'typhoid Mary'.
One would think we would have learned from our past
experience with HIV. Labelled the 'gay plague', misinformation led to
the vilification of the perceived perpetrators, namely the male
homosexual community. Now, a decade later, bashings and hatred remain a
legacy of that ignorance, and the homosexual community is still regarded
as pariahs by a significant minority of Australians.
What is going on? Many parents do not immunise because
of passionate religious beliefs. Many parents do not immunise because
they have too little information, and too little community support.
These people need access to information, resources and education.
Many parents, however, do not immunise because they have
looked carefully at the pros and cons, and have decided against. They
have taken more
care than parents who accept immunisation without thinking, and have
made their informed choice on behalf of their child.
Railing against these parents does far more harm than
good. It drives a wedge through communities, creates an atmosphere of
fear and mistrust, and paradoxically strengthens the influence of those
who oppose immunisation. Jack-booted enforcement, even when the cause is
good, inevitably leads to the entrenchment of opposition, and over time
can lead to community resentment. When lies or exaggeration are the
currency of both sides of a debate, the average parent is left more
confused, not less.
VI. Doctors and reporting
There is another, more subtle consequence of such an
emotional and polarised debate, one which should concern all doctors.
This may cause a knee-jerk reaction of denial and outrage on the part of
my colleagues, but it is my experience gained from those patients who
have sought my care in the past.
Doctors are responsible for reporting both cases of
vaccine-preventable disease, and adverse reactions to immunisations.
Both of these actions are subject to the biases and beliefs of those
doctors. I would predict, for example, a significant increase in
reporting of
vaccine preventable
disease given the current media focus. I would predict also a fall in
the reporting of adverse reactions for the same reason.
In the current climate, when adverse reactions do occur,
doctors seem less likely to attribute them to immunisation, and less
likely to report them. Why is this? Because doctors are human. Nearly
all have been forced to 'take a side' in the debate, and have
consequently had to become proselytes for vaccination. They have
cajoled, advised and persuaded vacillating parents about the benefits of
immunisation. There has been a tendency to play down the likelihood of
common adverse reactions and not provide information on rare but
important risks. Immunisations are thus commonly given without the
informed consent of the parents.
When problems arise after vaccination, these doctors
tend to play down the severity of the complaints, and will often deny a
connection with the vaccination. The reasons for this are unclear, but
may be a misplaced fear that such an admission may lead to the parents
avoiding future vaccinations. There are other possible reasons. The
adverse reaction reporting rate in Canada
2
is just under one in four thousand doses, while an active surveillance
system 4
for serious adverse reactions picked up five times as many reactions as
did the passive reporting system, such as that employed in Australia.
This is a problem. If there is a systematic error in the
under-reporting of adverse reactions, leading politicians, professors
and doctors to deny the existence of adverse outcomes, then suffering is
increased. The victims of immunisations become an embarrassment, and are
denied recognition and compensation. Essential research needed to make
immunisation safer and more effective is forgotten. We make do with
second rate vaccines, putting the health of all who choose to immunise
at unnecessary risk.
If we stifle debate and vilify those who choose not to
immunise, then we divide the community. Those who choose not to immunise
become pariahs, and are incorrectly blamed for almost any illness which
does occur. When parents see their child suffer from an unexpected
adverse effect, and are told that what they experienced is just not
true, they seek information. If the issue is not open for discussion,
then they may seek that information from less reputable sources.
Litigation increases when people believe they have been lied to by their
doctor and by health authorities, and the increased costs of medical
insurance will be passed back to the public in increased fees for their
medical care.
These are paths I, for one, do not wish to pass down.
They are complex issues, requiring openness, debate, information and
honesty on the part of all. They are not issues which are resolved by
inflammatory proclamations or complex, punitive schemes.
We have wasted millions of dollars already in futile
attempts to increase vaccination rates by media campaigns, threats, and
name-calling. We now face a complex system of withholding of
entitlements, which will most hurt the uneducated, the poor and those
who speak little English. No one can be proud of the gutter tactics
which are being employed by either side, because the real victims are
the ordinary Australians who simply want to do what is best for their
children.
It is now time to end the battle. A neutral forum is
needed, where such language and tactics are discarded, and where there
is an honest desire to reach consensus. All share a common goal, to
ensure the best possible health and outcomes for all Australian
children. They simply interpret the facts differently. Those differences
can and must be resolved, before they divide the Australian community
any further.
Signed
Dr Mark Donohoe
MB BS
VII. References
1. Arndt B, Sydney Morning Herald, 19/2/97.
2. Duclos P Pless R Koch J Hardy M Adverse events
temporally associated with immunizing agents.
Can Fam Physician
(1993 Sep) 39:1907-13
3. Magdzik W [Acellular pertussis vaccine (Pa)]
Przegl Epidemiol
(1995) 49(3):325-9
4. Farrington P Pugh S Colville A Flower A Nash J
Morgan-Capner P Rush M Miller E A new method for active surveillance of
adverse events from diphtheria/tetanus/pertussis and
measles/mumps/rubella vaccines
Lancet
(1995 Mar 4) 345(8949):567-9
5. Stratton KR Howe CJ Johnston RB Jr Adverse events
associated with childhood vaccines other than pertussis and rubella.
Summary of a report from the Institute of Medicine.
JAMA (1994 May 25)
271(20):1602-5
6. Fine PE Chen RT Confounding in studies of adverse
reactions to vaccines
Am J Epidemiol (1992
Jul 15) 136(2):121-35
7. Lilford RJ, Braunholz D, The statistical basis of
public policy: a paradigm shift is overdue.
BMJ 313: 7057, 603-7
8.
Communicable Diseases Intelligence,
Vol. 21 No. 2, 23 Jan 1997
9. Wortis N Strebel PM Wharton M Bardenheier B Hardy IR
Pertussis deaths: report of 23 cases in the United States, 1992 and
1993. Pediatrics
(1996 May) 97(5):607-12
10. Children's Immunisation Australia - April 1995.
Australian Bureau of
Statistics. ABS
Catalogue No. 43520
11. Skinner J March L Simpson JM A retrospective cohort
study of childhood immunisation status in northern Sydney.
Aust J Public Health
(1995 Feb) 19(1):58-63
12. Sydney Morning Herald, 27/2/97. Pages 1 and 6.
13. Levy MH Bridges-Webb C 'Just one shot' is not
enough--measles control and eradication
Med J Aust
(1990 May 7) 152(9):489-91
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