Vaccine disputes
BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2435 (Published 22 June 2009) Cite this as: BMJ 2009;338:b2435
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Peter Flegg is in error. Routinely, adverse reactions to vaccine are not recorded, monitored or investigated. There is only a passive recording system. Official NHS advice is to ignore even severe reactions and come back for further doses. Five years ago (almost to the day) I posted on MMR the Facts advice to this effect in BMJ Rapid Responses [1] which remains unaltered on-line with one or two temporary adventures[2]:
"Q:My son had a sever [sic] reaction to the first MMR jab. Does this mean that he is well protected from these diseases, or is a second dose still necessary?
"A: If a child has responded to all the components of the vaccine the first time, he will not have a problem being exposed to the viruses again. It’s like any one of us who is already immune meeting someone with the disease – the infection can’t get established. If he hasn’t made protection to all three diseases after the first time, then he would still be susceptible to those natural infections, and still needs the 2nd dose. Reactions after the 2nd dose are essentially the same as after the 1st dose, but if they do occur they are even rarer. There are no new side effects after the 2nd dose that do not occur after the 1st dose. The advice is therefore that it is safe for your child to have the 2nd dose in order that he is properly protected."
The advice was taken down for a brief period of months in late 2004 early 2005, and then early last year a line was added that you might want to consult your doctor in the event of a severe adverse reaction, but it was changed back again shortly afterwards. If you had rung your doctor you would probably (in my experience) have been given the bad tempered suggestion that you might want to give your child some Calpol but to stop making a fuss.
The advice is unambiguous evidence that recording of such events is pre-empted as a matter of policy and the data simply never collected: and almost certainly this goes for the entire schedule, not just MMR. The absence of data is then cited as evidence of safety. The DH and the NHS have had every opportunity to amend this folly but they simply persist and demonstrate their arrogance and recklessness.
[1] http://www.bmj.com/cgi/eletters/329/7456/0-g#65971
[2] http://tiny.cc/7vA7g
Competing interests: Autistic Son
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Lisa Blakemore-Brown asks "Have there ever been any adverse reactions to vaccines?", and says my failure to answer "speaks volumes".
Of course vaccines have side effects. These are extensively researched and well documented. I don't know of a single medically trained person who says any different. I ignored the question because (a) the answer has never been in doubt, and (b) I felt it was merely an irrelevant fishing expedition to lead us away from the focus of the review under discussion.
Competing interests: None declared
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David L Sackett, a retired Oxford University epidemiologist, is one of the very big cheeses of ‘evidence based medicine’ and a man of obvious independent thought and integrity. Of course, David Sackett is well aware that epidemiology is a very inexact science when it comes to nailing the causes of disease and the real truth behind preventing ill-health and extending life.
Epidemiological studies can only provide hypothesis generating evidence. Andrew Wakefield’s small case series published in the Lancet in 1998 only generated a hypothesis that MMR might be linked to bowel disease and regressive autism in a subset of genetically vulnerable children - a link that science is yet to disprove. However large or well designed, observational studies have a fundamental limitation – they prove absolutely nothing - they simply cannot determine the cause - or provide proof that one event is the cause of another.
In August 2002, David Sackett referred to the preventionists as ‘presumptuous’, aggressively assertive’ and ‘overbearing’ in the way these medical “experts” arrogantly attacked those who questioned the value of their recommendations. [1]
So who are the villains, asks Sackett. Who is to blame for the widespread application of “preventive” interventions that cause “disability and untimely death?” Sackett blames the medical “experts” “who, to gain private profit (from their industry affiliations), to satisfy a narcissistic need for public acclaim or in a misguided attempt to do good, advocate "preventive" manoeuvres that have never been validated in rigorous randomized trials.”
And Dr Sackett finishes his article by saying that,
“Experts refuse to learn from history until they make it themselves, and the price for their arrogance is paid by the innocent. Preventive medicine is too important to be led by them.”
[1] The arrogance of preventive medicine. David L. Sackett. CMAJ • August 20, 2002; 167 (4) http://www.cmaj.ca/cgi/reprint/167/4/363.pdf
Competing interests: None declared
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Such a lengthy reply - yet no answer to my simple question directed at Dr Flegg
Have there ever been any adverse reactions to vaccines?
His silence speaks volumes.
Competing interests: None declared
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How accurate are papers data even when totally “honest”?
Two studies or countries studies used to support the hypothesis that vaccines and autism are definitely not related are Denmark and Finland.
One Finnish study talks of 5 serious adverse effects per 100 000 while a Denmark paper shows nearly 20 000 episodes of convulsions alone from less than 500 000 children vaccinated.
Does this mean that a “convulsion” after a vaccine is not a serious event?
Denmark admits to 1 autism in 2 200 which of course changes with time.
The Finnish study proclaims no autism after vaccines and some take this as no autism at all in this country.
The national statistics for Finland separately shows autism here at 1 in 719 children again subject to change with time.
Diabetes also is noted to have exploded in Finland.
Along of course with increases in vaccinations.
As we learn from the death of Harry Clark six hours after a vaccine it proves nothing.
But how do you expect to find adverse events if you write them out of a study?
In Finland, convulsions mean "nothing" after vaccines, so 19 975 are effectively put down as “trouble makers” if they report their child for having a convulsive fit after a vaccine?
Or are the figures from this study totally useless to decide anything?
One lady who went to Dr Wakefield complained of a convulsion after an MMR vaccine. Unfortunately the child died before anything could be done.
The amount of work to show that particular vaccines were given to this child even before trying to link, associate or prove causality is enough to put off most people from doing more than grieving for a lost child not harmed by their trusted doctors.
The Finnish studies are nearly always supported by Merck and after counter papers put out by Dr Wakefield but again that's just association, temporal and proves absolutely nothing.
Competing interests: None declared
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Isabella Thomas is quite correct, I don't have first hand experience of the "hell" an autistic child or their family goes through. But that fact hardly disqualifies me from having an opinion on an alleged autism/vaccine link anymore than not seeing a child die from measles disqualifies her from having opinions on vaccination.
However if she would like to know the opinion of a doctor who has walked in her shoes, might I suggest she looks at what Dr Michael Fitzpatrick (author of the book "MMR and autism; What parent's need to know" and the father of an autistic child) has to say on the matter (1). Apart from his incisive comments about vaccines and autism, she might like to know that as long as 5 years ago he also pointed out the abuse doctors have had to suffer at the hands of those who campaign against MMR and who support Dr Andrew Wakefield(2):
"It seems that the vociferous and well-organised group of parents supporting the Wakefield campaign have effectively intimidated many of the prominent authorities in the field. The consequence of appeasing these parents have been serious. ...While Dr Wakefield has been lionised in the press and on television, these doctors have been subjected to scurrilous personal abuse, particularly through the internet. They include community paediatricians Brent Taylor, David Elliman and Helen Bedford, vaccine specialists Elizabeth Miller and David Salisbury, and, from the world of autism, Christopher Gillberg and Eric Fombonne."
Regarding the "discrediting" of the Wakefield Lancet paper, I really don't want to open up that particular can of worms in any depth as it's not really the subject of this particular debate. Suffice to say there are issues about significant conflicts of interest, allegations of serious professional misconduct relating to the study (currently under GMC review), allegations about data manipulation, questions about misrepresentation of bowel biopsy results that formed the cornerstone of the paper's claims, the revelation that Wakefield knew the bowel samples did not contain any measles virus RNA, the retraction of the interpretation of the paper by 10 of Wakefield's co-authors, and a statement from the then editor of the Lancet that the paper was "fatally flawed" and should never have been published. But that aside, the paper itself when judged entirely on its own scientific merits fails to make the grade, as Professor Trish Greenhalgh explains (3):
"In conclusion, the Wakefield study was scientifically flawed on numerous counts. I am surprised that neither the editor nor the reviewers spotted these flaws when the paper was submitted. Had they done so, the public would have been saved the confusion and anxiety caused by false credibility conveyed by publication of the study in this prestigious journal."
Finally, it would seem that Dr David Salisbury is fully justified in complaining about veiled threats that capital punishment would be appropriate for him, when one can read Dr Struthers implying vaccination proponents are “guilty of vaccine war crimes”. Is it any wonder that some activists overreact when they read such inflammatory comments?
If Dr Struthers uses such language in relation to the administration of vaccines, I must imagine he wrestles mightily with his conscience as a GP whose job it is to recommend children get MMR. Then again, perhaps he doesn’t advise it. Maybe he could enlighten us.
(1) http://www.spiked-online.com/index.php?/site/issues/C30/
(2) http://www.spiked-online.com/index.php/site/article/1855/
(3) http://briandeer.com/mmr/lancet-greenhalgh.htm
Competing interests: None declared
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Like the author of Spirit on the beehive, Victor Erice I believe a man's name should appear in print on only two occasions in his life - on his birth and death notices - hence I write to you with a degree of trepidation. The “Feature" by Ms Coombes however provokes.
I have been giving now single measles, mumps and rubella immunisations to my patients whose parents request it for over 12 years.
Indeed it is the only ethical course that I can follow - if I have at my means the ability to protect children safely and effectively from dangerous disease who would not otherwise be protected ( their parents will not give them MMR) then to deny them this protection - as many doctors do is clearly unethical.
I issue the usual caveats that their child will remain at risk from mumps and rubella until these vaccinations are given (I give measles first because this is the most serious.)
I used to say that there was no evidence that the vaccines were safer in terms of side effects when given singly ( the books - which are wrong, say that there is a 1/1000 risk of a febrile convulsion following single measles or MMR immunisation ) - nor was there evidence to suggest that the vaccines were more effective when given singly.
I now counsel parents that the vaccines are safer when given singly - my own results over a 12 year period _ no hospital admissions within 3 weeks in any child being immunised - despite immunising an "at risk" group _ those with other medical conditions, a personal or FH of febrile convulsions, adverse reaction to previous vaccines or multiple allergy.
They are also a little more effective in terms of inducing antibody response.
Both these observations have been presented in front of my peers and abstracts published. They are also available on my website www.healthychild.co.uk.
Rebecca Coombes' article makes much of the outlandish claims of the anti vaccine lobby but also -inadvertently quotes the now notorious Finland Study which was once championed by the pro immunisation lobby because it was a country wide study involving 4 m children who had MMR and no cases of autism were discovered .This was very impressive until you learnt that there were no cases of autism in Finland before MMR was introduced. It is now nolonger championed.
What parents need is an honest opinion and I know they feel that find that increasing difficult listening as they do to two groups who are either fervently behind (and profit from - immunisation) or those who, very often because of ghastly personal experience, rightly or wrongly attributed to vaccine administration, are feverently against.
What we need to say to parents is that giving the MMR is not without its dangers but is safer than not immunising. These dangers can be to a great extent be eliminated by giving the vaccines singly.
There was not a problem when the single vaccines were available on the NHS - and indeed vaccines when given are invariably more effective than when not.
The old adage that parents will "forget or pick and chose" has not been my experience. Indeed I have given many of my patients BCG and chickenpox immunisation neither of which are generally available on the NHS.
And yes I am one of those few unspeakables (and probably inedibles) who have relinquished my NHS responsibilities to follow a self enriching career in private practice.
Yours sincerely
Richard Primavesi FRCP FRCP(CH).
Competing interests: None declared
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It is now forty five years since I fought off measles as a young child. I barely remember the event and my mother vehemently denies having any anxiety over my ultimate survival. Mumps and German measles were innocuous childhood episodes and I survived all three maladies with my faculties relatively intact.
But my, how things have changed!
Over the years, the anger of the provaccine groups has vastly increased the virulence of the measles virus - through a mechanism of forced antigenic drift amongst others.
The diagnosis of measles is now tantamount to a death sentence, or worse.
However, to decline the MMR for one’s own child (because science has conferred MMR safety on most, but not all children) is now tantamount to handing down a death sentence on all those other innocents whose parents ‘responsibly’ allowed the vaccine.
Competing interests: My rapid response record is testament to the fact that I am vehemently against capital punishment, even for those guilty of vaccine war crimes. My children were lucky survivors of the MMR, with primary doses given in 1988 and 1992 respectively.
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Thomas Kuhn, in his book The Structure of Scientific Revolutions, argued that when the scientific effort expended on a problem increases—yet productivity declines—then the difficulty may lie with the assumptions (paradigms) on which the research is based.” The fight in the name of “science” of vaccination has reached this point with both the sides sticking to their points of view and not willing to understand the opposite point of view. It is time now to question the very hypothesis that vaccinations help always! Measles, a mild disease, is known to give protection against a whole range of allergic diseases including asthma. What will measles vaccine do other than the supposed protection against measles based on statistics? The latter is not pure science, anyway. One could dispassionately compare the disability and death statistics on either side of the fence-measles and the vaccine-primum non nocere.
The whole science of immunology is still in its infancy. Let both sides sit across a table and argue without malice to sort this controversy in the best interest of the future generation. If the recipients, the infants, had a say in the matter after getting all the facts from both sides, I feel they would not be too enthusiastic to have the jab! Vaccine protection against a disease hypothesis has many loopholes in it. True protection could come only from a disease. This might have to do with the cell function in individual cells. Our idea of Mendelian inheritance alone might not work as there are significant functional elements out with the nuclear nDNA. They have a significant role in disease and its management. They are the mitochondrial mtDNA. Has the time come to reexamine our ideas of aetiopathogenesis, pharmcodynamics and pharmacokinetics with this backdrop? Blame game should stop and should be replaced by understanding as propounded by the Danish philosopher, Spinoza.
Further reading: Douglas C. Wallace. Mitochondria as Chi. Genetics 2008; 179: 727-735.
Competing interests: None declared
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Vaccine expertise: the good, the bad, and the downright ugly
“But I do not regret publishing the original Wakefield paper.”
So said Richard Horton, esteemed editor of the Lancet in his book ‘Second Opinion, published by Granta Books in 2003. [1]
In this excerpt, Dr Horton went on to say,
“Creating the conditions for a resurgence of measles is bad medicine. Or is it? Good medicine, by this definition, means forcing families to immunize their children with the MMR vaccine. Fortunately, we do not yet live in a police state where public health doctors dictate what we can do (exercise and eat fruit) and what we cannot (smoke and eat burgers), even if their advice is wise and reasonable. If one of the results of freedom of choice is an adverse outcome for the public’s health, that is a regrettable but necessary consequence of our democracy. The responsibility rests with public health experts to educate and to persuade with understanding and compassion - not to berate with anger and frustration.”
And then Dr Richard Horton finished by saying,
“The MMR vaccine paper was published not because peer review indicated that the findings were true - peer review can never prove truth, only indicate acceptability to a few experts, as was indeed the case with Wakefield’s findings - but because the issue raised was so important for public health and so in need of urgent verification that not to publish with appropriate caveats would, in my view, have been an outrageous act of censorship.”
[1] MMR: The Lancet Fiasco. Richard Horton glorifies Wakefield, with "no regrets" over discredited MMR paper. http://briandeer.com/mmr/horton- wakefield.htm
Competing interests: None declared
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