Why can't the Daily Mail eat humble pie over MMR?
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7525.1148 (Published 10 November 2005) Cite this as: BMJ 2005;331:1148
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Mumps was not even notifiable as a disease until 1988 when the MMR
was introduced.
In 1985 in the British National Formularly it stated that there was no
justification to introduce a mumps vaccine in to the schedule as it is a
benign childhood illness, rarely any complications.
when there were 16 cases of mumps in Wales in recent months it turned
out that 15 had received two doses of MMR - the health officials admitted
that the mumps component was not effective.
While MMR may be safe many parents want to use single vaccines if for
no other reason than they are more effective vaccines than MMR conferring
a higher level of protection. What is really important is that children
ARE vaccinated; not that they are vaccinated by "brand x" MMR or by single
vaccines. If parents want to use single vaccines then they should be
supported. It's not as if they were refusing to vaccinate their children
merely that they wish to use a different route.
Department of Health should be encouraged to act responsibly and encourage
the current licence holder to restart production immediately or licence
its production to another company as a matter of urgency
http://petitions.number10.gov.uk/mumps-vaccs/
Competing interests:
None declared
Competing interests: No competing interests
The Cochrane Review of 2005 regretted:
“We were disappointed by our inability to identify effectiveness
studies with population or clinical outcomes. Given the existence of
documented elimination of targeted diseases in large population by means
of mass imunisation campaigns, however, we have no reason to doubt the
effectiveness of MMR." [1]
Remarkably the review came up with no scientific evidence that MMR
eliminated measles, so it remains a proper question whether it has? In its
report of a new study by Baird et [2] al last week the BBC carried the
following statement:
"The number of confirmed measles cases has risen from 56 in 1998 in
England and Wales to just under 1,000 in 2007, according to provisional
data.
"However, the impact of MMR on these figures is not clear." [3]
The most prominent instance of a measles outbreak last summer was
reported in Hackney by Michael Fitzpatrick himself in an article in on-
line Guardian "Right jabs: Before rejecting the MMR vaccination for their
children, middle-class parents should think of the risks measles can
present to the wider community" [4]. It was surprising that Fitzpatrick
focussed not on the vaccination status of the cases, but of another: "the
middle classes", omitting to mention that in many cases they would have
had single jabs. The likely conclusion was that this outbreak was occuring
in a vaccinated population. When quizzed about this Fitzpatrick offered
the following elucidation:
"Could I clarify a few points.
"There have been 150 cases of measles in Hackney (population >200, 000)
over the past three months.
"There have been 3 cases of measles in my practice (population >10,
000). These children had not received MMR.
"Though I do not have the data on the other cases, I understand that the
vast majority had not been fully protected against measles (with MMR at 12
-15 months and a pre-school booster).
"As this number of cases exceeds the number expected, this constitutes an
epidemic.
"The decline in middle class uptake of MMR has contributed to a population
coverage well below that required to protect against outbreaks of measles.
"When an outbreak of measles occurs it is more likely to spread rapidly
among socially disadvantaged children.
This is what we have seen in recent weeks." [5]
You cannot, of course, deduce anything from this unless you knew the
ages of those who had not been vaccinated or not received their "pre-
school booster". This was not, however, the original polemical slant of
the article.
I note as a parallel example the study by Harnden et al [6] on
whooping cough in which a one-time deadly disease is presumed eradicated
because of vaccination, but is simply commonly unrecognised.
It is regrettable if both the profession and the public are being
given less than transparent information about the effectiveness and
usefulness of vaccine.
[1]
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/fr...
[2] Baird et al, 'Measles vaccination and anti-body response in
autistic spectrum disorders',
http://adc.bmj.com/cgi/content/abstract/adc.2007.122937v1
[3]http://news.bbc.co.uk/1/hi/health/7226763.stm
[4]http://commentisfree.guardian.co.uk/michael_fitzpatrick/2007/08/right_ja...
[5]http://commentisfree.guardian.co.uk/michael_fitzpatrick/2007/08/right_ja...
-789052
[6] Harnden et al, 'Whooping cough in school age children with
persistent cough: prospective cohort study in primary care'
http://www.bmj.com/cgi/content/full/333/7560/174
Competing interests:
Autistic son
Competing interests: No competing interests
Fiona Godlee's powerpoint presentation to a British National
Formulary on 18 May 2004 "The Next MMR - can we do better?" can still be
downloaded from the web [1]. But it begs the important question what do we
do about the present one?
Admittedly, the public relations behind the the present Cochrane
document have been rather a success. What is not a success is the yawning
gap of reality. Even the six papers included the review relating to autism
and bowel disease were found to be defective. The review did not look at
anything which might establish a link between MMR autism and bowel
disease, so its proclaimed negative finding is of no significance.
The substantial matters are the issue of total failure:
"The design and reporting of safety outcomes in MMR vacccine, both
pre and post-marketing,are largely inadequate."
"The safety record of MMR is posssibly best attested by its almost
universal use; it evaluation cannot be divorced from its effectiveness and
the importance of the targeted diseases."
This last statement - and I apologise for returning to it - is a
complete appeal to unreason, and a statement of research bias. What, then,
is the point of having a review?
So, yes the media control is a great success: you can tell
journalists anything and they do not want to contradict the scientists,
but the true picture is not one of success but of irrationality and
ignorance. When the PR is over the medical profession ought to ask itself
some serious questions about what it is doing, and why?
[1]http://bnf.org/bnf/extra/current/noframes/450050.htm
Competing interests:
Autistic son
Competing interests: No competing interests
I have had passed on to me an article of March 2004 by John Grimley
Evans, the retiring Coordinating Editor of the Cochrane Dementia and
Cognitive Improvement Group (CDIG): 'Morality and Respectability, The Face
and the Mask'. The article considers how the funding by the Department of
Health for the British Cochrane Groups might be replaced. And it places
the immediately preceding events of February 2004, in which Andrew
Wakefield was pilloried by government and in the media for alleged non-
disclosure of interest in a revealing light:
"CDIG has always taken the view that it is in their own interest that
employees of drug companies should not be authors of a Cochrane Review.
They would inevitably be at risk of accusations of either bias or
disloyalty, whatever the scientific quality of their work. As the witch-
hunt over MMR illustrates, the mob goes for the man not the ball. But we
also believe that a global ban on funding from pharmaceutical companies
would be neither just nor wise. It would not be just because there are
many other sources of potential conflict of interest in Cochrane reviews
that escape similar damnation. Charities have donors wih pre-conceived
notions who must be kept sweet. Government research money is now heavily
under political influence; it would be a brave academic hoping for future
grants who used govenment funds to conclude the latest Downing-Street-
trumpeted health sevice initiative was garbage..." [1]
This puts the contradictions and lacunae of the present Cochrane
Review and its rather patchwork effect in alarming context. As John
Grimley Evans points out Cochrane is heavily dependent for its future
survival in finding favour with the industry, and industry funded
institutions. It would also be naive to suppose that the charities he
refers to are also not dependent on government and pharmaceutical industry
backers: in reality it all goes back to exactly the same sources, and the
linkage is there irrespective of a lack of specific connections between
particular products and their reviews. The apparently easy going attitude
of Evans contrasts notably with the recent House of Common's Health
Committee report 'The Influence of the Pharmaceutical Industry'[2].
In the meantime it is revealing to read that a medically senior
observer regards the contemporaneous MMR episode as a "witch-hunt". And
though not in the same breath he talks about the influence of Downing
Street in determining the outcome of research:
"...it would be a brave academic hoping for future grants who used
govenment funds to conclude the latest Downing-Street-trumpeted health
sevice initiative was garbage...".
In this context it ought not to be forgotten that one of the first
voices to be heard in the "witch-hunt" was that of the Prime Minister:
"There's absolutely no evidence to support this link between MMR and
autism...I hope now that people see that the situation is somewhat
different to what they were led to believe, they will have the triple jab
because it is important to do it." [3]
The catastrophe, I suggest, is that government has given up more than
the pretence at seeking objective science in determining policy. The
present study actually gives no basis at all for confidence in the safety
of the MMR. All we have is the empty mantra:
"The safety record of MMR is possibly best attested by its almost
universal use; it evaluation cannot be divorced from its effectivenes and
the importance of the targeted diseases"
and the admission that the real work has never been done. What a
terrible dereliction after 17 years. The public, however, have been told
something different.
[1] CDIG Newlsetter 10, p.8:
http://www.cochrane.org/newslett/CDCIG_Mar_2004.pdf
[2]http://www.parliament.the-stationery-
office.co.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
[3] BBC News, 'Top doctor wades in to MMR
debate':http://news.bbc.co.uk/1/hi/health/3512195.stm
Competing interests:
Autistic son
Competing interests: No competing interests
Dear Sir,
If vaccine trials were done properly in the first place, we wouldn't
be in this position today. When you study the Cochrane Review you can see
very clearly part of the shortcomings that lead to this situation. But
there is something else as well.
Not one vaccine that has been used today, has been trialled
correctly. Not the DPT, not the meningitis ones... not the MMR ... not
the influenza vaccine.
A vaccine to be tested, needs to take two large groups representative
of society, diseases, immunodeficiencies, cancers, the lot, and without
reference to their medical histories, split them into two groups. One
group get the vaccine, the other gets absolutely nothing. No placebo, and
certainly not the recently mockery of a placebo, which is a comparable
vaccine with an assumed safe profile.
Both groups are then compared.
And the scientists are set to repeat their mistakes yet again.
Here are the protocols for a new smallpox vaccine:
http://www.clinicaltrials.gov/ct/gui/show/NCT00079820
They asked for participants and here was the criteria.
>>>adult males or females who provided informed consent for
the study.
>>>adults 18 and 31 years (inclusive).
>>>good general health,
>>>female subjects must not be pregnant or lactating and be
on appropriate contraception or be a female unable to bear children.
>>>subjects be available for participation during the entire
study.
~~~~~~~~~~~~~~~~~~~~~
OKAY?
BUT>>>>
They didn't want you in the study if -----
~~~~~~~~~~~~~~~~~~~~~
>>>>>military service prior to 1989 or after December
13th, 2002.
>>>>>history of previous smallpox vaccination
>>>>>known/suspected history of immunodeficiency, or
with current radiation treatment or use of immunosuppressive or anti-
neoplastic drugs.
>>>>>subjects with a household member or intimate
contact with the same conditions listed above.
>>>>>known or suspected impairment of other
immunologic function.
>>>>>malignancy, including squamous cell or basal cell
skin cancer at vaccination site
>>>>>active autoimmune disease.
>>>>>subjects with known eye diseases or other
conditions that require the use of corticosteroid eye drops.
>>>>>known/history of cardiac disease.
>>>>>subjects who have been diagnosed with 3 or more
of the following risk factors for ischemic coronary disease:
a) high blood pressure
b) elevated blood cholesterol levels
c) diabetes or high blood sugar
d) first degree relative (for example, mother, father, brother, or
sister) who had a heart condition before the age of 50
e) smoke cigarettes
>>>>>subjects with a history of palpitations or
abnormalities of cardiac rhythm.
>>>>>subjects with odd ECG patterns
>>>>>subjects with a ten percent or greater risk of
developing a myocardial infarction or coronary death within the next 10
years.
>>>>>positive or elevated creatinine kinase, CK-MB, or
Troponin I laboratory test levels.
>>>>>abnormalities of clinical laboratory assessments.
past history or current diagnosis of chronic renal disease, adverse
reactions to drugs characterized by renal impairment, a serum creatinine
> 1.5 mg/dL, or presence of 1+ protein in urinalysis at screening and a
calculated creatinine clearance of not less than 80 mL/min.
>>>>>current diagnosis or past history of eczema.
>>>>>subjects with a household member or intimate
contact with the same conditions listed above.
>>>>>presence of acute, chronic, or exfoliative skin
conditions, open wounds, or burns.
>>>>>history of keloid formation.
>>>>>known allergies to MVA or to any known components
(Neomycin, Gentamycin) of the vaccine.
>>>>>known allergy to eggs or egg products.
>>>>>known allergies to any component of the Dryvax®
vaccine.
>>>>>Antibiotics in Dryvax® include neomycin,
streptomycin, chlortetracycline, and polymixin B.
>>>>>known allergies to any known component of the
Dryvax® diluent (i.e., glycerin and phenol).
>>>>>known allergies to any known component of VIG,
(i.e., thimerosal or previous allergic reaction to immunoglobulins).
>>>>>known allergies to cidofovir or sulphur
containing drugs, including probenecid, trimethoprim, and sulfonamide
antibiotics.
>>>>>transfusion of blood or treatment with any blood
product, including intramuscular or intravenous serum globulin within 6
months of the screening visit.
>>>>>positive serology result for HIV, hepatitis B
surface antigen, or hepatitis C.
>>>>>current diagnosis or history within six months of
the screening visit of drug or alcohol abuse disorders.
>>>>>significant acute or chronic psychiatric illness.
>>>>>female subjects with a positive serum pregnancy
test result
>>>>>subjects with a household member or direct
contact with someone who is pregnant or lactating.
>>>>>temperature or acute illness within 3 days prior
to vaccination
>>>>>inoculation with an inactivated vaccine with 14
days of Day 0 or with a live attenuated vaccine within 30 days of Day 0.
>>>>>subjects who have participated in another
investigational drug or vaccine trial within 30 days of Day 0.
>>>>>subjects who are planning on donating blood or
organs within 30 days of vaccination.
~~~~~~~~~~~~~~~~~~~~~~~~~~~
If the vaccine proves satisfactory in this trial, it will not show
that it is suitable for the whole population at large. It will only show
that in that very restricted population it did not appear to cause too
many problems.
If the FDA, or anyone else, then releases it to the general public,
then as Thomas Pynchon says in “Gravity’s Rainbow” .... “If they can get
you asking the wrong questions, the answers don’t matter.”
That is the problem with the MMR issue, which must be seen in the
context of all the vaccines that went before as well.
Vaccine trials have always asked the wrong questions.
Therefore, the protestations of those who say any vaccine is "safe"
have to be analysed, because if the questions the safety studes asked were
wrong in the first place, all other "answers" and jury-rig explanations
are largely irrelevant.
Hilary Butler.
Competing interests:
None declared
Competing interests: No competing interests
Sir/Madam
I am grateful to Michael Fitzpatrick for alerting us to the Cochrane
review of Demicheli, Jefferson et al into MMR and autism in his BMJ
article “Why can't the Daily Mail eat humble pie over MMR?”; I say that
tongue in cheek as I note that Dr. Fitzpatrick uses the Cochrane review to
attack Melanie Phillips for writing an article he terms a “symbol of the
woe-ful role of the media in the course of the MMR controversy”, and to
claim that “The recent publication of a Cochrane systematic review
concluding that there is "no credible evidence" of a link between the
measles, mumps, and rubella (MMR) vaccine and either inflammatory bowel
disease or autism provoked demands that the British tabloid newspaper the
Daily Mail apologise for its role in promoting the MMR-autism scare“ as it
is not clear whether Dr Fitzpatrick actually read the Cochrane review
since it does not appear to evidence his claims nor to have “provoked
demands” Fitzpatrick speaks of.
The Cochrane review is extraordinary in that there are certainly
statements in that paper which, as Fitzpatrick argues, might lead readers
to believe that the “MMR causes autism” debate can finally be laid to rest
and that MMR is basically a safe intervention; I refer to the authors’ “No
credible evidence of an involvement of MMR with either autism or Crohn’s
disease was found”….”but the impact of mass immunisation on the
elimination of the diseases has been demonstrated worldwide”…”the safety
record of MMR is possibly best attested by its almost universal
use”…”given the existence of documented elimination of targeted diseases
in large population by means of mass immunisation campaigns however we
have no reason to doubt the effectiveness of MMR” yet the review does not
appear to identify any concrete scientific proof for those statements.
The objectives of the review are clearly stated to be “To review the
existing evidence on the absolute effectiveness of the MMR vaccine in
children (by the effect of the vaccine on the incidence of clinical cases
of measles, mumps and rubella). To assess in children worldwide occurrence
of adverse events including those that are common, rare, short and long
term, following exposure to MMR”. The team searched 5000 articles and
pared them down according to their own criteria until there were only 31
studies that met the criteria for complete analysis – included in the
‘rejected’ 4969 studies were all those attributed to Wakefield et al –
therefore his evidence of alleged MMR-induced IBDs and papers of Vijendra
Singh et al with powerful evidence of alleged measles virus (and later
measles vaccine virus) induced autism. Rejection from the final 31 had
4969 articles discarded by the team’s specific criteria; of course one
cannot claim that the 4696 studies were invalidated by rejection,
therefore the team cannot claim for example that evidence for IBD/Crohn’s-
induced colitis does not exist as they ignored specific studies making
that claim.
The findings of the Cochrane review are therefore founded on careful
analysis of the 31 studies that met criteria for study; only they provide
evidence for conclusions drawn by the team about their objectives on
“absolute effectiveness” and “worldwide occurrence of adverse events” for
MMR.
I was therefore surprised, on analysing this paper for some
considerable time, that it appears to almost exclusively project the
inadequacies of the 31 studies and not their inherent ability to prove or
evidence the objectives set by the authors! In fact the authors make it
perfectly clear that none of the 31 studies can be safely relied upon to
evidence their objectives. Perhaps I can show this most readily by
referring readers to a simple statistical representation derived from the
authors’ critical comments on the value of the 31 studies from which they
attempt to attain their objectives: -
1. NO study reported complete vaccine identification e.g. lot
numbers, adjuvants etc.
2. 39% failed to report ANY vaccine strains
3. 10% reported the strain for only one component of MMR
4. 84% failed to give complete information on schedule, doses, route
of administration
5. 58% failed to report definitions for all possible outcomes; 23%
were single event specific
6. 19% had NO definitions for safety outcome measurements beyond a
description of temperature range measurements; only 13% had ONE outcome
with description, and 16% more than one outcome with description
7. 48% of those monitoring temperature gave NO further description of
either numerical range or base reading
8. 19% reported NO participants missing for ADR monitoring; for 3% it
was NOT POSSIBLE to determine if participants were missing; 55% had
‘clearly missing unintended event data’ of which 18% had under 10% missing
from all areas, 24% had between 11 and 20% missing, 47% had between 20 to
60% missing from all areas and 12% the number of child subjects missing
from all areas COULD NOT BE DETERMINED.
9. 26% of the studies had inadequate explanation for missing data and
for 12% no explanations were offered
10. 6% had discrepancies in reporting denominators
11. 3% excluded more than 33% of cases
12. 32% had insufficient information on study population and
enrolment
13. 23% had population descriptions that raised doubts as to the
generalisability of their conclusions to other settings
14. 3% had uncertainty about power and generalisability of findings
from single case only design study
15. For 2 GPRD-based studies the precise nature of controlled
unexposed subjects to MMR their generalisability was IMPOSSIBLE to
determine.
When one applies the above error-inducing factors to their respective
studies it is difficult to find one study devoid of sufficient error
likely to invalidate its findings. Is it any wonder the authors of the
Cochrane review also concluded “external validity of included studies was
low”, that ”descriptions of the study populations, response rates
(particularly in non randomised studies), vaccine content and exposure
(all important indicators of generalisability) were poor and
inconsistently reported”, and that there was in addition “inadequate and
inconsistent descriptions of reported outcomes, limited observations
periods (maximum 42 days) and selective reporting of results”?
The question must be; why were supportive statements made by the
authors regarding safety and effectiveness of MMR which their detailed
dismantling of the validity of the 31 studies so obviously invalidate? One
detects almost ‘bipolar’ outpourings when comparing, for example, a
statement like “Existing evidence on safety and effectiveness of MMR
vaccine supports current policies of mass immunisation” with “the design
and reporting of safety outcomes in MMR vaccine studies, both pre- and
post-marketing, need to be improved and standardised definitions of
adverse events should be adopted”.
Perhaps the most damning statement for MMR vaccination the team makes
appears in their ‘Background’. They state “ despite its worldwide use, no
systematic reviews of the effectiveness and safety of MMR are available”.
Clearly, and despite the Cochrane review, the worlds’ children continue to
be afflicted by lack of a review which provides essential evidence of
effectiveness and safety of MMR vaccination..
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
Onisillos Sekkides states: "(measles) which is still among the
top 10 global killer diseases." One cannot compare the situation in
Africa with the situation in the UK or US (apples to apples and all that);
what the children in Africa really need is not vaccinated for measles as
much as help with the AIDs crisis, better malaria control, an end to the
constant flare-ups of civil war, and most importantly reliable sources for
potable water and nutritious food.
In the US, according to statistics kept by the US Government, deaths
attributable to measles had declined by nearly 85% a full 20 years before
the introduction of the monovalent measles vaccine and 30 years+ before
the introduction of the MMR.
I do not suggest that the MMR vaccine is impotent in reducing the
frequency of occurance of measles. I do question the frequent parroting
of disingenuous "facts" to "prove" the position of no connection between
the MMR and autism (ends do not justify the means), more so when it is so
easy in our cyber-society to show the flaws, misconsceptions and
falsehoods is said arguments.
The bottom line is the MMR-autism controversy remains unresolved, and
stonewalling and misrepresentation of the limited facts by government
personnel and public health authorities does a disservice to society at
large. It may well be that there is indeed no link between the MMR and
autism. The preliminary clinical studies however seem to support a link
in some cases. What our public health officials should be doing is
exploring that link so we can determine how to screen out the vulnerable
infants, properly compensate the "allowable loss" should it be deemed a
good risk/benefit trade-off from society's perspective, and eliminating
those products which cause more damage to society than the disease they
are developed o prevent.
Competing interests:
father of an autistic child (non-regressive)
Competing interests: No competing interests
Simple:
Look at the biological and cognitive profiles of the children who
parents consider have been damaged by this or any other vaccine, instead
of: ignoring them or blaming them; doing everything possible to prevent
this happening; year in year out re-hashing irrelevant epidemiology and
trashing those professionals who dare to also consider some children have
suffered adverse reactions to vaccines.
Competing interests:
Specialist Psychologist in Autism and the spectrum of disorders associated with it
Competing interests: No competing interests
Where are the passages in Cochrane that prove that MMR does not cause
autism or bowel disease?
Competing interests:
Middle-class (autistic son)
Competing interests: No competing interests
Re: mmr the choices
Mr Fleming is incorrect in his assumption that single vaccines "are
more effective vaccines than MMR conferring a higher level of protection."
History proves him wrong.
Before the introduction of MMR, children received monovalent measles
vaccine, and (girls) monovalent rubella vaccine.
The year MMR was introduced, there were 86,000 cases of measles and
16 deaths (despite the widespread use of single measles vaccine). In the
17 years between introduction of single rubella vaccine and the
introduction of MMR there were over 730 cases of congenital rubella
syndrome and thousands of terminations performed.
I don't wish to see a return to the level of illness and mortality we
experienced 20 years ago. Combined MMR is more effective and as safe (and
possibly even safer) than the individual vaccines. The vaccination
schedule is also more likely to be completed with combination vaccines
meaning better protection for vulnerable children.
Competing interests:
None declared
Competing interests: No competing interests