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Re: The MMR story is not complete
 

I should like to ask Richard Smith [1] how it could be that Ben Goldacre's account of the MMR story is complete when it has been made virtually impossible, particularly in this country, for those on one side of the debate to present their case, not least because proponents of MMR safety blank all criticisms? Meanwhile, and for long time the media - so far from supporting or giving space to Andrew Wakefield - have been largely intimidated into silence.

As it is Goldacre has never answered the challenge of the fundamental flaws in the epidemiology of MMR and autism, as, for instance, I set out for him in my Rapid Response of 21 September 2007 [2], citing four studies he had used in his pivotal award winning polemic 'Never Mind the Facts', published in the Guardian in December 2003 [3]. Three of the studies, I pointed out, were found when reviewed by Cochrane to be seriously deficient. In fact none of the six autism studies reviewed by Cochrane was judged to be of low risk of bias (and these were supposed to be the best). Cochrane demonstrated its own bias by suggesting that the absence of evidence for safety should be balanced against the need to eradicate the diseases, [4] [5] stating in conclusion:

"The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunisation with MMR cannot be separated from its role in preventing the target diseases." [4]

Moreover, it is less than certain that even if the epidemiology had been better conducted than it has been whether it would have necessarily given a clear answer regarding Wakefield's hypothesis. Almost unreported in this country the former head of the National Institutes of Health, Bernardine Healy, told CBS news earlier this year that the Institute of Medicine Review of 2003/4 had been over-dependent on epidemiology, and that in order to properly research the autism/vaccine issue you would have to look at medical subgroups (as, indeed, Wakefield had been doing)[6].

Also, almost unreported in this country has been the publication of the Hornig study [7], the first study to even half heartedly replicate the Uhlmann study of 2002, which layed out Wakefield and O'Leary's initial laboratory findings [8]. While the rhetoric surrounding the publication of the Hornig study has trumpeted in the US the final eclipse of the Wakefield hypothesis the interior detail suggests anything but (perhaps why we have heard so little of it so far in this country).

In the first place the study confirms the consistency of O'Leary's results with two most higly rated labs in the US. Secondly, while the study only had five cases which of the Wakefield pheno-type it confirmed two positive results for measles virus RNA from ileal samples, across all three laboratories - one from the autistic group and one from the control group, all of which had gut pathology (and all cases having MMR). The study does not tell us whether symptoms in two cases developed pre or post vaccination, though it would certainly bolster their case for "lack of association" if it was pre. And so far from disputing the results Uhlmann in the discussion it states:

"Our results differ with reports noting MV RNA in ileal biopsies of 75% of ASD vs. 6% of control children [10], [41]. Discrepancies are unlikely to represent differences in experimental technique because similar primer and probe sequences, cycling conditions and instruments were employed in this and earlier reports; furthermore, one of the three laboratories participating in this study performed the assays described in earlier reports. Other factors to consider include differences in patient age, sex, origin (Europe vs. North America), GI disease, recency of MMR vaccine administration at time of biopsy, and methods for confirming neuropsychiatric status in cases and controls. Participation in the current study required confirmation in cases of the presence of an AUT diagnosis and exclusion in controls of AUT or other developmental disturbances."

Another reason why we might find this troubling in this country is that study confirms the appropriateness of the kind of investigation for which Drs Wakefield, Walker-Smith and Murch are presently on trial at the General Medical Council. Not only is this a terrible injustice to the doctors - irrespective of whether the hypothesis is correct or not - but it has effectively infringed the rights of autistic children in this country who are now widely being denied appropriate medical support, as the National Autistic Society has warned [9].

[1] Richard Smith, 'Becoming Ben', BMJ 1 October 2008, http://www.bmj.com/cgi/content/full/337/oct01_3/a1856

[2] John Stone 'Re: Restrictions on hospitality apply to doctors and journalists', BMJ Rapid Responses http://www.bmj.com/cgi/eletters/335/7618/480#176662 

[3] Ben Goldacre, 'Never mind the facts', Guardian 11 December 2003: http://www.guardian.co.uk/life/feature/story/0,,1103958,00.html 

[4] V Demicheli, T Jefferson, A Rivetti, D Price,[Review] 'Vaccines for measles, mumps and rubella in children', Cochrane (Wiley 2005), http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html 

[5] Clifford G Miller, 'Questions on the Independence and Reliability of Cochrane Reviews, with a Focus on Measles-Mumps-Rubella Vaccine', http://www.jpands.org/vol11no4/millerc.pdf 

[6] CBS News,'Leading doctor: vaccines-autism worth study', http://www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml 

[7] Mady Hornig, Thomas Briese, Timothy Buie, Margaret L. Bauman, Gregory Lauwers, Ulrike Siemetzki, Kimberly Hummel, Paul A. Rota, William J. Bellini, John J. O'Leary, Orla Sheils, Errol Alden, Larry Pickering, W. Ian Lipkin, 'Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study', published 4 September 2008, http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140#s3 

[8] V Uhlmann, C M Martin, O Sheils, L Pilkington, I Silva, A Killalea, S B Murch, J Walker-Smith, M Thomson, A J Wakefield, and J J O'Leary, 'Potential viral pathogenic mechanism for new variant inflammatory bowel disease', Molecular Pathology, Mol Pathol. 2002 April; 55(2): 84–90, http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=11950955 

[9] NAS, 'General Medical Council hearing against Dr Wakefield', http://www.nas.org.uk/nas/jsp/polopoly.jsp?d=459&a=13952 

"The National Autistic Society (NAS) is keenly aware of the concerns of parents surrounding suggested links between autism and the MMR vaccine. The charity is concerned that the GMC hearing, and surrounding media coverage, will create further confusion and make it even more difficult for parents to access appropriate medical advice for their children.

"It is particularly important that this case is not allowed to increase the lack of sympathy that some parents of children with autism have encountered from health professionals, particularly on suspected gut and bowel problems. Parents have reported to the NAS that in some cases their concerns have been dismissed as hysteria following previous publicity around the MMR vaccine. It is crucial that health professionals listen to parents' concerns and respect their views as the experts on their individual children.

"There is an urgent need for further, authoritative research into the causes of autism, to improve our understanding of the condition, to respond to parents' concerns and to enable us to ensure that there are appropriate services and support in place to meet people's needs."

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Re: Becoming Ben.
 

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Re: The Dawn of McScience
 

The sun has set on honest, independent science whose primary goal is the discovery of truth. I don’t know when the sun went down, but like Richard Horton, I do know that a new era has dawned.

Of course, Dr Horton, present esteemed editor of The Lancet, described the enlightenment of this new dawn in his book on the MMR crisis. [1] In the third chapter, Horton eloquently describes how, with the colonization of science, the traditional norms of disinterested inquiry and free expression of opinion have been given up to the harvest of huge revenues from the global wellness industry. He tells us that “subtle yet insidious changes to the rules of engagement between science and commerce are causing incalculable injury to society, as well as to science.” And in the description, Horton subtly implies that Andrew Wakefield, apparently burdened with enormous financial conflicts of interest in his researches into the possible causes of autism and childhood bowel disease, was an important marker of this malignant process.

We will all remember that Andrew Wakefield and paediatricians Professors Walker-Smith and Murch are currently being tried by the GMC, a trial that will last nearly two years at a cost to the ordinary doctor of millions of pounds.

Andrew Wakefield, who dared to question the rights of the vaccine- industrial-complex has recently said,

“It is not a question of not vaccinating. I’m not against vaccinations. I don’t know for sure vaccines cause autism but I suspect they do. The opposition just states categorically it does not. But they don’t know either.” [2]

By apparently invoking the good offices of the new corporate science, Ben Goldacre can sneer “unattractively” at the idea of a possible link between autism, bowel disease and vaccines, particularly the MMR.

[1] The Dawn of McScience. Richard Horton. 3rd Chapter, MMR Science &Fiction, Exploring the Vaccine Crisis. Granta Books 2004.

[2] Autism Doc claims government led witch hunt against him. Phil Doherty, Sunday Sun. Sep 28 2008. http://www.sundaysun.co.uk/news/north- east-news/2008/09/28/autism-doc-claims-government-led-witch-hunt-against- him-79310-21915131/

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Re: Re: The MMR story is not complete
 

Andrew Wakfield's conflicts of interest are now well-documented. That there never was any reason to suspect an MMR-autism link, and that, to date, there is still no valid reason to continue to believe in such a link (and belief is all there is going for it) is no reason for the faithful to give up their misdirected fight. No mountain of evidence, regardless of it's height, will suffice to convince them to pursue more fruitful endeavors. Nor, does it seem, do people like John Stone understand that science and the null-hypothesis will never be able to prove the MMR doesn't cause autism, or earthquakes, or hurricanes, or financial crises.

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Re: Re: Re: The MMR story is not complete
 

I am surprised that John Snyder [1] is allowed to attack me in the terms that he has. This is the essence of ad hominem:

"Nor, does it seem, do people like John Stone understand that science and the null-hypothesis will never be able to prove the MMR doesn't cause autism, or earthquakes, or hurricanes, or financial crises." [1]

This is instead of addressing any of the points I made [2]. It should be pointed out that MMR is a pharmaceutical product, and if the only resort to people who question its safety (like any other product) is to attack their character or intellectual competence, there is something wrong in the terms of the discussion. If witnesses to adverse drug events are treated like this by Snyder, what weight can be placed on his opinion? And what makes MMR different from other products, placing it forever beyond scientific investigation?

Snyder has no answer to the deficiencies in the epidemiology documented in my post, either from Cochrane [3] or former National Institute of Health chief Bernardine Healy [4]. And he has no answer for the fact that the passage in the Hornig study I quoted absolutely does support continuing scientific concern about this matter. Hornig [5] failed to test the Wakefield hypothesis adequately by fudging its data set, unlike Uhlmann [6], which it validates in the discussion. Healy has stated that to test the vaccine/autism hypothesis you would need to study sub- groups (as in fact Wakefield and colleagues were doing in the Uhlmann study). The only sense I can make of the passage in Hornig is that they are saying that if they had had a similar study group to Uhlmann they would likely have replicated its results. As it is we might look at the semantics of the paper's title: not "No Association between Measles Virus Vaccine and Autism with Enteropathy" but "Lack of Association" [5]. What it documents is precisely that Hornig et al have been over-eager to jettison the hypothesis.

[1] John Snyder, 'Re: The MMR story is not complete', BMJ Rapid Responses 14 October 2008, http://www.bmj.com/cgi/content/full/337/oct01_3/a1856 

[2] John Stone, 'The MMR story is not complete', BMJ Rapid Responses 8 October 2008, http://www.bmj.com/cgi/eletters/337/oct01_3/a1856 

[3] V Demicheli, T Jefferson, A Rivetti, D Price,[Review] 'Vaccines for measles, mumps and rubella in children', Cochrane (Wiley 2005), http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html 

[4] CBS News,'Leading doctor: vaccines-autism worth study', http://www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml 

[5] Mady Hornig, Thomas Briese, Timothy Buie, Margaret L. Bauman, Gregory Lauwers, Ulrike Siemetzki, Kimberly Hummel, Paul A. Rota, William J. Bellini, John J. O'Leary, Orla Sheils, Errol Alden, Larry Pickering, W. Ian Lipkin, 'Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study', published 4 September 2008, http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140#s3

 [6] V Uhlmann, C M Martin, O Sheils, L Pilkington, I Silva, A Killalea, S B Murch, J Walker-Smith, M Thomson, A J Wakefield, and J J O'Leary, 'Potential viral pathogenic mechanism for new variant inflammatory bowel disease', Molecular Pathology, Mol Pathol. 2002 April; 55(2): 84–90, http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=11950955 

Send response to journal:
Re: The MMR story is not complete.
 

The tone of John snyder’s response is unhelpful.The public health hierarchy has persisted over the years in promoting the MMR as safe by promulgating epidemiological studies that have variously proved to be irrelevant, inconclusive, or seriously methodologically flawed.

Approximately 35 such studies have been used in the UK to promote the MMR as safe and unconnected to the upsurge of bowel disease and autism worldwide. In referring to these studies, what is generally meant is that the authors have carried out large-scale population based studies, either by comparing cases (with autism) and controls (no autism) in terms of MMR exposure, or by comparing those exposed and unexposed to MMR in terms of autism or Autism Spectrum Disorder as an outcome. Whilst it is tempting to assume that studies of large populations are somehow ‘better’ by virtue simply of their size, this is by no means necessarily the case. Neither are they ‘safety’ studies, a fact of which John Snyder should be well aware, and if he is not, it is of serious concern.

The failure of the population based studies that are frequently cited as supporting the safety of MMR is in their total lack of reference to the original hypothesis formulated by Wakefield.(1) In a recent presentation at the International Meeting for Autism Research (IMFAR) (2) this year Dr Carol Stott produced evidence to indicate that of over 50 studies claiming to test what can be referred to as the Wakefield hypothesis, only five actually addressed it fully, and four of these supported it, at least in part. Of these four, two were clinical studies and two were ‘population’ based.

Another significant failing is that whilst population based evidence from case-control or cohort studies might indicate a possible association between two or more factors – and to some extent be used to indicate causality - it can obviously not be applied to prove that in any particular case X did not cause Y.

John Stone quite correctly quotes Dr Bernadine Healy ex head of the National Institute of Health and a member of the Institute of Medicine in the USA who has publicly stated on the issue of using epidemiology: “Populations do not test causality, they test associations. You have to go into the laboratory and you have to do designed research studies in animals”.

And on the vaccine/autism link: “Certain public health officials in the government, have been too quick to dismiss the concerns of these families without studying the population that got sick. I haven’t seen major studies that focus on 300 kids who got autistic symptoms within a period of a few weeks of the vaccine. I think that the public health officials have been too quick to dismiss the hypothesis as “irrational” without sufficient studies of causation. I think that they often have been too quick to dismiss studies in the animal laboratory, in mice, in primates, that do show some concerns with regard to certain vaccines”.

With regard to the Lipkin/Hornig study (3) it should be noted that only five children involved in this research met the criteria of the original hypothesis (normal development, MMR vaccination, bowel disease, leading to autism). Too small a sample, one would have thought, particularly in view of the criticism levelled at Dr Andrew Wakefield's team for publishing research in 1998 based on only 12 children. (In fact, an addendum to that original study revealed the assessment of a further 40 patients, 39 of whom had the novel form of bowel disease as described.) Interestingly one of the five children in the Lipkin/Hornig paper was found to have measles virus in the gut. But the simple fact is, this study does not really address whether MMR causes autism, let alone rule it out, as the authors erroneously claim. It does, however, confirm the presence of distressing and painful bowel disease in many autistic children. In fact the authors have credited Dr Andrew Wakefield with being the "first to recognize the importance of gastrointestinal disease in autism."

Some other interesting quotes from the authors may assist John Snyder in formulating a programme and protocol to assist autistic children, no matter the cause of their painful bowel disease:

“This study confirms that kids with autism often have "unrecognized and undertreated bowel complaints." Dr Ian Lipkin.

“These intestinal problems may well be linked to the developmental regression seen in about 25% of kids with autism”. Dr Mady Hornig

“Unless a treatment protocol is developed, many of these children will live with painful, undiagnosed medical conditions that will grow more serious as they become teenagers and adults.” “Many of the symptoms of autism such as self abusive behaviour including self-mutilation, head- banging, unexplained outbursts, atypical sleep patterns, disrupted sleep or night awakenings, are actually symptoms of pain that a child is not able to communicate”. Timothy Buie, (gastro-enterologist).

The evidence of parents re a link with MMR is overwhelming and compelling.I suspect this will become the most shameful episode in public health history.

Bill Welsh
President
Autism Treatment Trust, 29A Stafford Street, Edinburgh. EH3 7BJ

(1) Ileal Lymphoid Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children, Lancet, 28th February 1998

(2) A novel form of Inflammatory Bowel Disease (IBD) with Pervasive Developmental Disorder: A Systematic Review of the state of the evidence" Poster Presentation, IMFAR, London 2008 Stott CM.

(3) Hornig M, Briese T, Buie T, Bauman ML, Lauwers G, et al. 2008 Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. PLoS ONE 3(9): e3140 doi:10.1371/journal.pone.0003140

Send response to journal:
Re: Re: Re: Re: The MMR story is not complete
 

Dear Mr.Welsh

You wrote;

'The public health hierarchy has persisted over the years in promoting the MMR as safe by promulgating epidemiological studies that have variously proved to be irrelevant, inconclusive, or seriously methodologically flawed'

This, sadly, doesn't apply to ABA/Lovaas 'recovery from Autism is posible' does it? Define Autism? It's an 'Umbrella' term is't it? That is all I can conclude from having studied it for 14 years as a parent.

Studies of MMR (and any other concotion developed by pharma) will always remain 'inconclusive' due to the fact everyone is genetically unique. There will always be a small portion of the populace reacting poorly to a substance- see 'contains trace of nuts' on some food packaging.

There is a Vaccine Damage Payment Unit in the UK.

The 'flagging' system needs improvement and diagnosis of autism and all related disorders needs to revert to as it was; a multi-disciplinary team over a period of time with a 2nd impartial opinion is the only way autism should be diagnosed to prevent, what has become, a label-loving, blame culture of vast proportion.

I'd sincerely like to know how many people became disabled or died from measles as compared to [] from reaction to MMR?

Yours sincerely

E.C.Lucy Robillard

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Re: Financial conflicts - shock horror
 

Andrew Wakefield is continuously attacked on the basis that he had crippling financial conflicts of interest - with regard to his research in MMR - which he did not disclose.

At the time, the Lancet did not request authors to disclose conflicts of interest. So Dr Wakefield broke no rules. Perhaps more pertinent is the fact that a huge number of researchers, and those who write clinical guidelines, are far more 'conflicted' than Andrew Wakefield ever was - or is - or probably could ever be.

When the National Cholesterol Educational Program (NCEP) produced their last set of guidelines, no financial conflicts were initially identified. (The panel recommended far more intensive cholesterol lowering than previous guidelines, and would therefore encourage far greater prescribing of statins).

After several petitions to the National Institutes of Health (The parent organisation to NCEP), the conflict statement was - reluctantly - published. (See below). There were ten members of the panel. (These conflicts were publishes on the NIH website, and are in the public domain (Ref 1))

Dr. Grundy has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.

Dr. Cleeman has no financial relationships to disclose.

Dr. Bairey Merz has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

Dr. Brewer has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.

Dr. Clark has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.

Dr. Hunninghake has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.

Dr. Pasternak has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.

Dr. Smith has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.

Dr. Stone has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering- Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.

To castigate one doctor for his fatal conflicts of interest when writing a clinical paper seems to be humbug of the highest possible level when we allow other doctors to write treatment guidelines whilst having such major financial conflict of interest. Sauce for the Goose must also be sauce for the gander.

Ref 1: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm 

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Re: Re: Re: Re: Re: The MMR story is not complete
 

This is a good question, and one that focuses the issue squarely upon the balances of risk and benefit, which is where it should be. If MMR results in more benefit than harm, we should continue to use it. It does, and so we should.

If there is evidence that single measles, mumps and rubella vaccines cause less harm than MMR, I am unaware of it. To the contrary there is evidence that single vaccine schedules leave children vulnerable to the infections for longer periods of time and that the number of children fully completing the course of vaccination drops significantly as compared to combined MMR.

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Re: Re: Financial conflicts - shock horror
 

I note Malcolm Kendrick's interesting letter. However, I would also point out that Andrew Wakefield presented evidence earlier this year to the GMC that the Lancet and its editor, Richard Horton, were aware of his involvement in the MMR litigation at the time of the publication of the controversial article, whether or not it constituted a competing interest (which is debatable [1] - unlike the cases that Kendrick refers to). Some of this was reported in BMJ [2] although not in the media at large. Richard Horton disputed the detail of the claim to BMJ [2] but the matter is at the very least unresolved, and it would be unwise to jump to any conclusions.

A more troubling conflict might be that of Dr Surendra Kumar, who chairs the present fitness to practice hearing into the three Royal Free doctors [3]. Kumar sits on two committees of the medicine licensing authority (MHRA), the Independent Review Panel for Advertising and the Independent Review Panel for Borderline Products [4] and in the latest declarations of competing interests available ( both unsatisfactorily dating from 2004) Kumar discloses a shareholding in MMR defendents GlaxoSmithKline [5,6].

Given Kendrick's sympathetic view of this issue, I would also finally like to remark on the huge disproportion in the coverage of the 'MMR affair' between the reporting of the allegations against the doctors and the reporting of the defence.

[1] John Stone, '"MMR Science and Fiction" - the Richard Horton story, BMJ Rapid Responses 25 September 2004, http://www.bmj.com/cgi/eletters/328/7438/528#75516 

[2] Owen Dyer, 'Wakefield admits fabricating events when he took children's blood samples' 19 April 2008, http://www.bmj.com/cgi/content/full/336/7649/850

[3] Andrew Jack, 'MMR doctor denies abuse of trust' Financial Times, 16 July 2007, http://us.ft.com/ftgateway/superpage.ft?news_id=fto071620071825004908&page=2 

[4] Medicine Act 1968, Advisory Body Report 2007, p.84 and 89, http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2032766&RevisionSelectionMethod=Latest 

[5] INDEPENDENT REVIEW PANEL FOR ADVERTISING, http://www.mhra.gov.uk/home/groups/es- cb/documents/committeedocument/con003563.pdf  

[6] INDEPENDENT REVIEW PANEL FOR BORDERLINE PRODUCTS, http://www.mhra.gov.uk/home/groups/es- cb/documents/committeedocument/con003564.pdf 

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Re: Re: Re: Re: Re: Re: The MMR story is not complete
 

Peter Flegg makes a valid point about the importance of the risk/benefit ratio, however it is equally important to examine how we have arrived at a juncture where UK citizens are denied the choice of single vaccines.

We know from Department of Health records that single vaccines are more effective – it’s set out in two editions (1996 and 1988) of “Immunisation Against Infectious Disease”, published for professionals by HMSO. The contention that MMR is more effective cannot be sustained. Why if MMR is more effective would this same committee decide (in 1996) to introduce the second dose of MMR? MMR fails to protect around 10% of its recipients against measles, and 10% against mumps. These groups overlap: some are unprotected against both measles and mumps. Rubella in MMR works as well as when given singly. Given singly, both rubella and measles vaccines protect at least 95% of recipients for 15 or more years; mumps for around 10 years. There was never any call for second doses when single vaccines were the policy, and therefore there would be no need now to repeat doses of single vaccines. One successful dose provides immunity in the recipient for 15 years or more.

Peter Flegg maintains that the use of single vaccines introduces unacceptable delay; actually it seems perfectly adequate to separate rubella and measles by 6 weeks, measles and mumps by 3 months according to the World Health Organisation. The real delay is introduced by MMR. If the first dose fails to protect against mumps or measles, effective protection is delayed until the pre-school booster, 3 years later.

(The decision to include mumps in the vaccination schedule requires detailed examination. Mumps vaccination from one year old, as at present, prevents safe acquisition of life-long protection as a juvenile, only to wear off just at the age when protection is really needed. No booster immunisation is currently offered when it could be, at age 10. Even if it were, the entire mumps vaccination campaign has created a new generation most of whom will be susceptible to mumps as adults!).

Returning to the risk/benefit ratio, this would of course alter markedly if autism were accepted as an adverse reaction to MMR vaccination, however as that has not yet been acknowledged we must settle for the information currently provided by the government on one side, and the media, often using Freedom of Information, on the other. According to the Health Protection Agency two children under the age of ten have died from measles in the UK in the last 15 years (1). Both children were immune-compromised and had other serious medical conditions. My understanding is that laboratory proof can be provided for only one of the cases. During the same (or similar) period the number of deaths attributed to MMR and MR vaccination is approaching 30 (2) (3) (4).

I trust that answers Peter Flegg’s question satisfactorily. While it may, in some perverse sense, be understandable that public health officials are reluctant to concede that the MMR vaccination programme has damaged thousands of UK children, (they would after all be incriminating themselves); given the evidence, both scientific and anecdotal, it is surely high time that some brave soul in medicine had the courage to raise his head above the parapet and admit liability. Step forward Dr Peter J Flegg.

Bill Welsh President Autism Treatment Trust 29A Stafford Street, Edinburgh. EH3 7BJ

(1) Health Protection Agency: Measles Epidemiological Data Deaths by Age Group, 1980 – 2007. http://www.hpa.org.uk/webw/HPA  (2) Sunday Express, Focus by Lucy Johnston, Health Editor: “Were all of these children killed by the triple MMR jab?” 13/1/2002. (3) Sunday Express, “Two babies die days after the MMR jab”: By Lucy Johnston, Health Editor. 18/6/2006. (4) Telegraph, “Secret report reveals 18 child deaths following vaccinations”. Beezy Marsh, Health Correspondent, 11/2/2006.

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Re: The risk/benefit ratio for MMR vaccination
 

In response to Mr Welsh, I am afraid his response to my comments about risk/benefit of MMR did not "answer my question satisfactorily". The benefits of vaccination are overwhelming, and his idea that should autism be caused by vaccination, the risk/benefit ratio would "alter markedly" is somewhat off target. It is important to consider that as long as vaccination remains at a high level, herd immunity will protect many of the vulnerable, and this artificially skews the risk/benefit ratio to make it seem as though vaccination can incur significant risk. But should insufficient numbers of children be immunised to maintain herd immunity (as is becoming the case), the true risks of measles will become transparently obvious, and these are significant.

Mr Welsh tries to downplay the lethality of measles by saying that one of the two reported deaths from measles in under ten year olds was in someone who did not have "laboratory-confirmed measles". My understanding is that there have also been other recent measles deaths in children over this age. To have deaths from measles in the UK over a period of time when the disease was not endemic and when there have been only a few thousand cases of clinical disease is a clear demonstration of how serious this infection can be, and attempts to pretend this is not the case are absurd. What Mr Welsh seems to be forgetting is that without MMR vaccination, every child in the UK would get measles (around 600 000 each year), around 100 000 would need hospitalisation with infections such as pneumonia, between 80 and 120 would die each year, and many hundreds more would suffer permanent brain damage from encephalitis. And that's without even considering the burden from other problems like congenital rubella.

Mr Welsh's own claim that the number of "deaths attributed to MMR and MR vaccination is approaching 30" is wildly inaccurate, and relies on media sources rather than being based on cited scientific evidence and fact. The deaths he alludes to were reported to have followed all types of vaccination, and not just MMR as he categorically claims. Many of these deaths will be entirely unrelated to the vaccine, as was shown to be the case with some of the deaths following meningococcal vaccine. With respect to the few deaths reported following MMR vaccination, again there appears to be considerable disconnect, since as anyone might expect, deaths from background problems such as SIDS occur all the time and occasionally these will coincide with a post-vaccination period. Any reports of serious or fatal side effects must be considered in the light of the Joint Committee on Vaccination and Immunisation's reported rate of "serious" reactions to MMR of around 0.03 per thousand vaccine doses.

Even if it were to be shown that a small proportion of autism cases were to be triggered by MMR (something that fifteen years of intensive research has so far failed to do), the balance of benefit to risk would remain heavily in favour of vaccination.

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Re: Re: The risk/benefit ratio for MMR vaccination
 

I am in full agreement with Dr Flegg’s excellent arguments, and would like to add one further matter which should be taken into account. While there are no satisfactory studies showing a causal effect of MMR in relation to autism, there are at least 2 papers in the literature, one with an exceptionally large population, which hint at an actual protective effect of MMR against autism or autistic spectrum disorders.

The first was the huge Danish study of Madsen et al.(1) where there was a trend in this direction for autistic spectrum disorders, though not quite reaching significance at the 5% level (RR = 0·83; 95% CI: 0·65–1·07). Grove(2) suggested that this trend might be due to rubella causing some cases of autism.

The next was the large case-control study of Smeeth et al.(3) in which the odds ratio for autism and other pervasive developmental disorders with respect to MMR was below 1 and similarly almost at the 5% level of significance (OR = 0·86; 95% CI: 0·68–1·09).

It really is sad that some people avoid MMR vaccination in the mistaken belief that it causes autism, when some evidence actually shows a trend in the opposite direction.

Trevor Watts

1. Madsen KM, Hviid A, Vestergaard M, et al. A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism. N Engl J Med 2002; 347:1477-1482.

2. Grove ML. MMR reduces risk of autism shock! electronic BMJ 2003 June 11. http://bmj.bmjjournals.com/cgi/eletters/326/7401/1272#33193 

3. Smeeth L, Cook C, Fombonne E et al. MMR vaccination and pervasive developmental disorders: a case-control study. Lancet 2004; 364: 963-69.

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Re: Re: Re: The risk/benefit ratio for MMR vaccination
 

Trevor Watts might like to bear in mind my original observation in this correspondence that the Cochrane Review of MMR had not judged any of the six autism studies included as being of low risk of bias [1,2], and these included the Madsen and Smeeth studies.

Of Madsen Cochrane remarked:

“The interpretation of the study by Madsen was made difficult by the unequal length of follow up for younger cohort members as well as the use of the date of diagnosis rather than onset of symptoms of autism.” [2]

The significance of this was more than slightly obscured by the fact that Cochrane failed to explain that "the younger cohort members" were the vaccinated group.

Of Smeeth Cochrane remarked:

“In the GPRD - based studies (Black 2003; Smeeth 2004) the precise nature of controlled unexposed to MMR and their generalisability was impossible to determine…The study (Smeeth 2004) appeared carefully conducted and well reported, however, GPRD-based MMR studies had no unexposed (to MMR)representative controls. In this study the approximately 4% to 13% seemed to be unexposed controls regarded by the authors as representative. Such a small number may indicate some bias in the selection of controls.” [2]

I am not sure - in view of this shortcoming - how carefully conducted the study could be said to be. It should be noted as well that the authors could not distinguish regressive cases of autism from the database [3], and there was under-ascertainment of ASD cases by an order of magnitude (or two). For instance, in another study Andrews et al only found an incidence of just over one in a thousand [4] during a period in which National Statistics reported a figure of 1 in a hundred [5], while another GPRD based study by Jick and Kaye reported an incidence of autism of 1.6 boys in 10,000 in 1993 to 9.5 in 10,000 in 1999 [6]. It is surprising given the somewhat wobbly nature of this data source for autism diagnosis that researchers have returned to it so repeatedly.

Peter Flegg does not seem to be on top of the detail. The two reported deaths from measles in recent years were of two teenagers, not under-10s. The HPA's reporting of the recent tragic death of a 17 year-old is somewhat anomalous (as Bill Welsh suggested):

"The first death from acute measles infection since 2006 has been reported. A 17 year old with underlying congenital immunodeficiency was admitted to hospital with respiratory distress and pneumonia on 20 April following contact with a case of measles. The patient deteriorated and was transferred to ITU a week later with respiratory failure, but subsequently died (five weeks later). Serum samples and nasopharyngeal aspirates taken at various times have confirmed that the patient had infection with a strain identical to the measles strain (MVs/Enfield.GBR/14.07 genotype D4) that has now been circulating in the UK for over a year." [7]

They kept testing him to show viral serum reactions but make no mention of the typically occuring symptoms of the illness. Pharyngeal aspirates would confirm the presence of the virus but not that the patient had the disease. A positive serum test would only be significant if there was a 4-fold increase in titer [8], but if this was the case you might expect that the HPA would mention it, whereas they only record the presence of the virus. A Freedom of Information enquiry has provided no further information.

Flegg cannot expect his view of the balance of risks to be taken seriously while he disregards the cries of woe from so many parents: he only further demonstrates his bias. If he was really concerned for vaccine safety he would be listening, and so would the Department of Health.

[1] John Stone, 'The MMR story is not complete', BMJ Rapid Responses 8 October 2008, http://www.bmj.com/cgi/eletters/337/oct01_3/a1856 

[2] V Demicheli, T Jefferson, A Rivetti, D Price,[Review] 'Vaccines for measles, mumps and rubella in children', Cochrane (Wiley 2005), http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/frame.html 

[3] Smeeth L, Cook C, Fombonne E, Heavey L, Rodrigues LC, Smith PG, Hall AJ, 'MMR vaccination and pervasive developmental disorders: a case- control study', Lancet, 2004 Sep 11-17;364(9438):963-9.

[4] Nick Andrews, Elizabeth Miller, Andrew Grant, Julia Stowe, Velda Osborne, and Brent Taylor, 'Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association', Published online September 1, 2004 PEDIATRICS Vol. 114 No. 3 September 2004, pp. 584-591 (doi:10.1542/peds.2003-1177-L), http://pediatrics.aappublications.org/cgi/content/full/114/3/584 

[5] National Statistics, Snapshot of Prevalence of Children's Mental Disorders, http://www.statistics.gov.uk/cci/nugget.asp?id=1229 

[6]Jick H, Kaye L, Epidemiology and possible causes of autism,1: Pharmacotherapy. 2003 Dec;23(12):1524-30.

[7] Health Protection News Archives 20 June 2008 http://www.hpa.org.uk/hpr/archives/2008/news2508.htm#meas0508

[8] MEASLES SURVEILLANCE: GUIDELINES FOR LABORATORY SUPPORT

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98vol24/dr2405ea.html#a 

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Re: Risk/Benefit ratio.
 

I would have thought that reading and understanding earlier contributions on a particular subject in Rapid Responses would be a pre- requisite to making comment. Peter Flegg and Trevor Watts appear to have skipped this imperative. My response of 16th October more than adequately covered the issue of the use of ‘epidemiological’ studies in relation to MMR safety. The two studies mentioned by Trevor Watts were far from conclusive as he would have learned if he had been genuinely interested in finding out. Peter Flegg on the other hand totally ignores my argument for a single measles vaccine and goes into a diatribe about the dangers of measles. No one wishes the return of measles, however that is exactly what is happening, not because of Wakefield, not because of the media, not because parents are unintelligent, but as a direct result of the spectacular mismanagement of the vaccination programme. Uptake of the MMR in parts of London is now below 50%, in Birmingham it is below 30%. This, after the Department of Health injected over £10 million on promotion and the Health Protection Agency re-invented itself as a propaganda machine appearing more intent in controlling public opinion on the MMR safety issue than in providing the contextual information on which people can make an informed judgement.

To resort to fear-mongering as a tool in a quest for MMR’s universal approval only weakens the stance of public health officials. “Fear is the parent of cruelty” and in a civilised and pluralist society fear is an unacceptable weapon to use to influence your own citizenry.

Even a cursory examination of the history of MMR’s introduction reveals a series of incredible mis-calculations and mistakes. Vaccination should never raise challenges greater than, or even similar to, those already found in natural home life. Vaccination should be easier, safer and more convenient, or there is no point to it. Live, acute, systemic viruses do not allow each other to co-habit the same person – they express themselves one at a time. MMR should have been rejected on elementary, precautionary principles – it is not a matter of science. We should have stuck to single vaccines (mumps and rubella pre-secondary school), or at the latest reverted to them in 1996.

The early history of the removal after four years of two brands of MMR (Pluserix and Immravax)due to severe adverse reactions clearly illustrates that the vaccine had not been tested properly, and over a long enough period to identify long term adverse reactions, and in fact had been licensed prematurely. The launch of a booster MMR vaccine eight years after the original’s introduction should have alerted all and sundry to the knowledge that the world’s children had been and were being subjected to a crude experiment.

There has been a serious intellectual deficit in the MMR safety debate caused primarily by health officials unwilling to question a deeply flawed vaccination programme that contains a vaccine that I strongly contend is damaging a sub-set of our precious children.

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Re: The risk/benefit ratio for MMR vaccination
 

I would take issue with Dr Flegg with regard to his comment: "the benefits of vaccination are overwhelming", he should know because it has been referred to by the Health Protection Agency that the passive surveillance system only collects a small proportion (about 10%) of adverse vaccine reactions. If you have an ineffective system of collecting vaccine adverse events you have inaccurate safety data. The Department of Health is therefore conducting a national immunisation service without full knowledge of the terrible risks involved for some children.

Dr Flegg claims that "as long as vaccination remains at a high level, herd immunity will protect many of the vulnerable". What about those children vulnerable to adverse vaccine reactions? Do they not count?....based on the current adverse event reporting system it seems not.

In trying to shore up the MMR programme the Department of Health and its allies have turned their faces against clinically investigating all suspected MMR vaccine damaged children. By publicly attributing deaths to SIDS and coincidence there will be no justice for the vaccine damaged child and no improvements in vaccine policy or procedures to protect vulnerable children.

I also think it is a bit hypocritical to accuse Bill Welsh of downplaying the lethality of measles when the government and medical profession downplay the real risks of vaccine reactions to support the MMR OR NOTHING policy which clearly undermines Dr Flegg's herd immunity theory. One has to ask the question: where does the Department of Health's interests lie? Is it to protect the nation's health, or to protect officials, and the pharmaceutical industries' lucrative patents for new combination jabs?

Dr Flegg is making assumptions about the 30 deaths following MMR and MR vaccines. He is doing what many health professionals seem to do; he has no personal knowledge of the individual cases but immediately jumps to the conclusion that they are all coincidences, easily explained by background prevalences. Where is his evidence for these assumptions?

JABS has received reports from the parents of these 30 children. Four of these children have been assessed by the Government's Vaccine Damage Payment Unit and tribunals have awarded payments. Some of these children died from vaccine induced SSPE after being given a number of measles containing vaccines. Twelve of the children died under the age of two years and were therefore ineligible for assessment by the VDPU. There is an absurd clause which does not allow claims to be investigated until the child passes its second birthday. Just remind me Dr Flegg, when are most baby vaccines given?

The same families could not pursue investigation through the courts because parents cannot access legal aid if the child has died. The Legal Aid Board has its own strict criteria in that there is a cost/benefit rule. As the child has died and obviously does not have any dependents and does not need a long-term care package the value of the child's life if a claim was successful would be rated at about £7,000, it would cost more than this to take the case to court therefore the family would not be allowed to pursue a claim. What price justice?

Why should any parent put their trust in a system that is so one sided? No policy-maker or medical professional (including you, Dr Flegg) takes any risk whatsoever, that burden is solely carried by the child and the family. What makes the situation worse is that the family are not aware that they are taking any risk and if the worst does happen they are on their own.

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Re: Re: The MMR story is not complete
 

“The MMR story is not complete” and will not be complete until the cause of regressive autism is identified and appropriate prevention and treatment strategies are developed.

I am not a doctor, therefore the following should not be construed as medical advice. The conclusion of an investigation into the physical disorders associated with regressive autism are: The primary cause of regressive autism is bottle feeding followed by vaccination.

Using ‘colitis’ to explain the relation between vaccines and colitis: From the Internet: “The cause is of ulcerative colitis is unknown. … Attacks may be provoked by many factors, including respiratory infections.” [1] Pertussis, mumps and measles, in addition to being respiratory infections are components of vaccines. Thus, both MMR and DpT vaccines can cause colitis, a physical ailment common in regressive autistic children.

Bottle feeding followed by a respiratory infection can cause regressive autism. (Again, pertussis. mumps and measles are respiratory infections.)

Bottle feeding is a risk for all the physical ailments because it predisposes the child to obstructive sleep apnea (OSA) [2]. (A marginal respiratory system can also dispose the child to OSA, which directly underlies all the physical ailments. The intestines, the pancreas and the kidneys will be used as examples. During an apnea the diaphragm makes multiple attempts at efforts 10 to 15 times normal effort in the attempt to overcome the airway obstruction. The intestines, pancreas and kidneys are ‘pounded’ hundreds of times a night resulting in colitis, diabetes and gout. Although reflux and ear infections are also secondary to OSA, different mechanisms are involved. [3,4]

References

1. http://www.nlm.nih.gov/MEDLINEPLUS/ency/article/000250.htm 

2. Google: “palmer apnea snort”

3. Herr J. Chronic cough, sleep apnea, and gastroesophageal reflux disease. Chest. 2001 Sep;120(3):1036-7.

4. Herr JR. Re: Autism--ear infections--glue ear--sleep disorders. J Autism Dev Disord. 2003 Oct;33(5):557.

(For more details google: three sources of autism)

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Re: Response to Welsh /Fletcher
 

I totally agree with Mr Welsh that reading through the rapid responses is a pre-requisite to making comment. I am therefore sure he will agree with me when I take Mr Stone to task for neglecting to do this.

It was Mr Welsh who originally stated that (24th October) that "two children under the age of ten have died from measles in the UK in the last 15 years". On the 28th October I replied: "My understanding is that there have also been other recent measles deaths in children over this age". On 31st October, Mr Stone said: "Peter Flegg does not seem to be on top of the detail. The two reported deaths from measles in recent years were of two teenagers, not under-10s."

Someone may well "not be on top of the detail", but it is obviously not me, and nor is it me who has failed to read the responses before making comment. But perhaps we can move on, and leave Mr Stone and Mr Welsh to resolve their own differences of opinion about the exact age of these dead children between themselves. Personally I am not concerned so much about the precise age of the children, just deeply saddened that these totally unnecessary deaths have occurred in the first place.

I am pleased to hear that Mr Welsh is of the opinion that "no-one wishes the return of measles". But as he says, that is exactly what is happening. Since the summer there have been nearly 100 cases of measles in unvaccinated children in Blackpool, and this has resulted in numerous hospital admissions and at least one near-death. There are many reasons why we find ourselves in the situation where large swathes of the UK's population are still susceptible to measles because they are unvaccinated. Mr Welsh is correct that mismanagement of the vaccination programme may well be one of them, but let us not forget that prior to the adverse publicity following the Wakefield debacle vaccination rates were quite acceptable. The bulk of the blame, as Dr Goldacre pointed out, lies with the media for spreading sensational and patently untrue scare stories about MMR vaccine, and with the persisting eagerness of certain individuals and groups to foster the idea that the benefits of vaccine are outweighed by the harm. Both of these factors have resulted in a very confused perception in the mind of the general public about the (small) risks involved with MMR vaccination.

I am also sorry to see Jackie Fletcher fall into the same trap as John Stone by failing to read my responses properly. She should note that I pointed out that Bill Welsh categorically stated that the number of deaths following MMR or MR vaccination was “approaching 30”, but his references for this information revealed to me that these numbers came from miscellaneous reports of deaths following any vaccine, and not just MMR. I did not “immediately jump to the conclusion that they were all coincidence”. What I did was point out that in many cases the association with vaccination was shown to be entirely coincidental (for example, one of the deaths reported following meningococcal group C vaccination was due to subsequent infection with a different strain of bacterium). Perhaps to clarify any confusion there may be in the minds of Mr Welsh and myself about the number of deaths, Jackie Fletcher could say exactly:

1) How many deaths have been reported following MMR and not other vaccines?

2) What was the time lag between vaccination and death?

3) What is the medical evidence to show MMR was the direct cause of death in these cases? Some valid references would be nice, rather than alarmist reports from the Sunday Express masquerading as evidence.

Whilst I agree with Ms Fletcher that it seems perverse that claims for vaccine damage can only be made for someone over the age of 2 years, she implies that the Vaccine Damage Payment Unit (VDPU) has assessed as many as 18 deaths over this age (since she says 12 of the “30” deaths have been unable to be assessed because they occurred under 2 years of age). Can she tell us exactly how many of these 18 other deaths have been directly attributed to MMR by the VDPU?

Without this information, I am afraid that wild claims about there being “30” deaths from MMR vaccine must remain purely speculative, and that when deciding on the risk/benefits of MMR vaccine this information should be viewed with a very jaundiced eye until it is properly confirmed.

Send response to journal:
Re: Response to Peter Flegg.
 

Dear Sir,

Peter Flegg suggests that to further accurate understanding of the issues, that Jackie Fletcher come up with definitive data and references to back up her comments that deaths can follow MMR vaccine.

Peter Flegg also said, "On the 28th October I replied: "My understanding is that there have also been other recent measles deaths in children over this age".

In order to assist the readers of rapid responses in understanding all issues involved, could Peter Flegg please put aside his "understanding" on measles deaths, and provide readers with the following definitive information and references for them:

1) The number of all deaths from measles since 1998.

2) The ages and sex of all those deaths.

3) Whether or not the people who died had absolute proof that measles was the direct cause of their deaths, as opposed to, "it was the doctor's understanding..."

4) How many of the people who died had immunodeficiencies, cancer, or any other underlying condition which would have contributed to their deaths.

5) Whether or not the anecdotal near-death/s mentioned by Peter Flegg also had an immunodeficiency, chronic illness or any other underlying condition which contributed to their near-death/s.

History, and the evidence of today, proves that the majority of children who contract measles have neither complications nor die.

It would be useful to use this unique opportunity to spell out the immunological/biological basis for measles complications and deaths. With that information, sensible, factually based discussion on the topic can resume, rather than the current fear mongering, which insinuates that every child on the face of the earth could die of measles.

Hilary Butler.

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Re: Response to Dr Flegg
 

In response to Dr Flegg's statement: "Since the summer there have been nearly 100 cases of measles in unvaccinated children in Blackpool, and this has resulted in numerous hospital admissions and at least one near-death". Just to make it clear Dr Flegg I too do not wish to see a return of measles epidemics in the UK. However, vaccine adverse reactions with long term damage and death are not acceptable either and must be prevented. That is why JABS advocates screening and choice when it comes to vaccinating children - not the MMR or nothing policy of the government/DoH and its supporters.

Dr Flegg wrote: '..prior to the adverse publicity following the Wakefield debacle vaccination rates were quite acceptable..'

Dr Flegg appears to be out of touch with the history of the MMR debacle. Neurological problems were known to be associated with MMR as reported in the minutes of the Joint Committee on Vaccination and Immunisation meeting dated 8 March 1988 prior to the introduction of three brands of MMR. The UK pre-introduction trials of the MMR vaccine were wholly inadequate lasting just three weeks. The evidence that the trials were inadequate and the JCVI's decision to support MMR was flawed is quite clear when it's noted that two of the three brands had to be withdrawn as they contained Urabe vaccine found to be causing a high level of mumps meningitis in children. In September 1992 the then Chief Medical Officer, Sir Kenneth Calman, announced the withdrawal at a press conference. Many of the severely disabled children and some of the children who had died, known to JABS, had had these brands of MMR. Parents whose children had suffered severe neurological problems started to raise the issue and MMR uptake began to fall slowly but surely from 1994. If Dr Flegg would like to confirm this he could contact the Health Protection Agency.

The Japanese health authority used a similar strain of mumps in its MMR. The vaccine was banned in 1993 and a Japanese court determined that 1,065 children were eligible for compensation following severe neurological damage.

Dr Flegg wrote: '..The bulk of the blame, as Dr Goldacre pointed out, lies with the media for spreading sensational and patently untrue scare stories about MMR vaccine, and with the persisting eagerness of certain individuals and groups to foster the idea that the benefits of vaccine are outweighed by the harm........Both of these factors have resulted in a very confused perception in the mind of the general public about the (small) risks involved with MMR vaccination...'

Quite clearly the Government and the medical profession are closed to any open discussion about vaccine side effects and tactically are of one mind when looking for someone to blame for the fall in uptake of MMR. Remove choice, blame the parents, blame Dr Wakefield, blame the media, blame anyone rather than be held accountable for vaccine damaged children. Please tell me who else is going to raise this issue if not the parents of vaccine damaged children?

Families are well aware that the Department of Health has a different agenda from a parent. The DoH is trying to get the 'herd' vaccinated in the most cost effective and quickest way. If some children are damaged by the process then that appears to be acceptable to the DoH as long as adverse media publicity can be kept under control. The DoH is playing a numbers game with our children. As long as fewer children suffer the rare consequences of measles then all seems to be well: except accurate statistics on the rate of serious adverse reactions are not being gathered. Without this no one can determine if acute conditions like measles are being replaced by chronic conditions such as epilepsy, neurological damage, acquired autism, juvenile arthritis, juvenile diabetes etc.

Very few suspected vaccine adverse reactions are put forward to the Government monitoring body by medical professionals. Unless every suspected serious reaction is reported and investigated thoroughly the medical authorities do not and cannot have accurate safety data on vaccines. Therefore, I repeat, parents have a right to know, from whatever source, that the DoH is conducting a national immunisation programme without full knowledge of the terrible risks involved for some children.

In response to Dr Flegg's questions: the information JABS and its legal team had collected with regard to some 1200 suspected serious adverse reactions and deaths following MMR and MR vaccines was presented to the Health Minister and her most senior DoH officials at the meeting in 1997. I suggest Dr Flegg contacts Prof David Salisbury, one of the officials present at that meeting, and ask how the data was handled and why. From where we stand the issue was raised at the top level with the Health Minister and DoH officials - they simply chose to dismiss the evidence out of hand without any credible clinical follow up to determine either causation or 'wild' claims. One has to wonder why?

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Re: More on the risk/benefit for MMR
 

I am quite happy to respond to Hilary Butler. It is quite appropriate to weigh the risks from measles as well as the risks from MMR when considering the risk/benefit equation of vaccination, and I am glad she raised the topic.

If we take data from the last 10 years, we will have to factor into the risk/benefit equation the information that around a 15 million doses of MMR have been dispensed in this period (assuming 85% vaccine uptake) and around 4000 cases of measles have been notified.

I have been asked for replies to these questions:

1) The number of all deaths from measles since 1998

On a global basis, WHO/Unicef estimate that in 1999 there were estimated to be 873 thousand deaths from measles, reducing to 530 thousand in 2003 as a direct result of vaccination initiatives (1). Assuming this relative reduction has continued, then since 1999 there have been 5.3 million deaths, nearly as many as died in the holocaust. Almost all of these deaths would be preventible through vaccination.

However, I guess you mean UK statistics. I can only report what has been officially recorded by the relevant agencies, and have no personal knowledge of the cases involved. According to the HPA, from 1998 to 2007 there have been 12 cases of “deaths” (2). One of these is provisional, and one has subsequently been revised as “known not to be measles” (implying the remaining cases were known to be measles). However, as I am sure you already know, with the exception of one case, these deaths represent delayed deaths from the neurological complications of measles contracted during the time before vaccination, when measles outbreaks were unfortunately very common, and are probably cases of subacute sclerosing panencephalitis, or SSPE (something we will no doubt see the return of if the current escalation in measles continues). People worry about the BSE time bomb – they should realise that measles carries a similar risk.

One death from acute measles occurred in 2006 in a “13 year old male who had an underlying lung condition and was taking immunosuppressive drugs”. However, earlier this year the HPA reported there has been another acute death, this time a 17 year old male, who was reported to have had some hereditary immunodeficiency.

2) The ages and sex of all those deaths

I have insufficient information on this, bar that concerning the 2 deaths from acute measles.

3) Whether or not the people who died had absolute proof that measles was the direct cause of their deaths, as opposed to, "it was the doctor's understanding..."

I don’t know if the people who died had time to be aware of what was killing them, but the clinicians caring for these cases would have had no doubt. Acute measles is a relatively easy clinical and laboratory diagnosis.

4) How many of the people who died had immunodeficiencies, cancer, or any other underlying condition which would have contributed to their deaths.

Both the deaths from acute measles had underlying immunodeficiency. To pre-empt your next question (which would be to say that “normal” children do not die from measles in the UK), let me say that these deaths demonstrate quite irrefutably the case for universal measles vaccination. These two children would never have been allowed to receive live MMR vaccine; so they depended upon herd immunity to keep them safe from catching measles. In a world where there was no measles vaccine, these two children would have been exposed to measles in infancy, with no doubt the same outcome. Poor vaccination rates lead to lowered herd immunity, and can directly be linked to these unfortunate deaths. It is precisely because some children are more vulnerable (yet cannot be protected through vaccine) that herd immunity is so vital.

5) Whether or not the anecdotal near-death/s mentioned by Peter Flegg also had an immunodeficiency, chronic illness or any other underlying condition that contributed to their near-death/s.

I gave reference to one case of near death from the Blackpool 2008 outbreak. This young, unvaccinated child did not have an underlying immune deficiency or other disorder, and has fortunately returned to full health.

To address Ms Butler’s other comments, I agree with her that it is not at all likely that every child on the face of the earth could die from measles (although 5 million have done exactly that in the last 10 years). The only reason more children do not die of measles in the UK is that herd immunity is still sufficiently high to protect those who cannot or have not been fully immunised. This is changing, as measles outbreaks spread throughout the UK. I have no doubt that another vulnerable group (infants too young to be vaccinated) will see deaths within its ranks before too long. That is not fear mongering, but the simple reality of measles infection.

To return to the risk/benefit equation for MMR versus measles infection, during the last 10 years the case fatality for acute measles in the UK has been in the order of 1 in 2000. To entail a similar degree of risk from MMR, we would need to have seen 7500 deaths from MMR vaccination.

1. http://www.unicef.org/progressforchildren/2005n3/measles.php

2. http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733835814 

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Re: Re: Response to Dr Flegg
 

I can reassure Ms Fletcher that I am not out of touch with the issue of MMR and possible neurological reactions to the vaccine. I have worked in clinical paediatric and adult infectious diseases since 1985, and have personally seen cases of encephalitis due to the Urabe strain of mumps virus in MMR. I have also seen many more cases of encephalitis following natural mumps infection. Even with the Urabe strain virus, vaccine-linked encephalitis was four times less likely to occur than after natural mumps infection (1), and since it was replaced in MMR by the Jeryl Lynn strain in 1992, no cases of post-vaccination encephalitis have been recorded.

Ms Fletcher feels that those in authority are not open to the possibility of vaccine side effects or reactions, or are unwilling to act to improve vaccine safety, and that serious reactions are not investigated. However, reactions are taken seriously, the example raised by Ms Fletcher of encephalitis following Urabe strain MMR being an excellent case in point. This problem was initially raised and reported by astute clinicians. It was then appropriately investigated both clinically and epidemiologically, with the result that the offending vaccine product was removed from further use in MMR. I agree that there will always room for improvement regarding monitoring of vaccine reactions, and I would support any efforts in this regard.

It appears that some respondents here subscribe to what is termed the "Nirvana fallacy", where if a course of action does not lead to perfection, it is preferable to do nothing (2). This strategy is totally inappropriate with regard to vaccine-preventable childhood infections, because doing nothing will ultimately lead to greater harm than if vaccines are universally used.

I am afraid Ms Fletcher has failed to adequately reply to my questions about deaths following MMR. She previously stated she had personal insight as National Co-ordinator of JABS into the details of all vaccine-related deaths. I merely asked for information on exactly how many deaths had been attributed to MMR, and what type of verification or evidence there was to show MMR was the cause of death. I still await her reply.

As I stated in my last response, in order for the risk/benefit equation to be tipped in favour of leaving children unvaccinated against MMR, there would need to have been more than 7500 deaths from MMR in the last 10 years.

(1). Miller E, et al. Lancet 1993; 341, 979-82. Risk of aseptic meningitis after measles, mumps, and rubella vaccine in UK children.

(2) http://en.wikipedia.org/wiki/Nirvana_fallacy 

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Re: In response to Peter Flegg's use of data.
 

Dear Sir,

Peter Flegg says that there would have to be an average of 750 MMR deaths a year, to tip the balance in favour of not vaccinating with MMR.

During the rationing of the second world war, in 1943, measles death rate in UK was 773 (1), and it never approached that rate again.

In the fifteen years before the measles vaccine was licensed in the UK death rates never went above 200; in the ten years before the vaccine was introduced, the death rate never went above 150. After 1953, deaths rates were never of the order of 1 per 2,000.

The measles vaccine was licensed 24 years later in 1967, and did not reach significant levels of uptake for quite some years after that. In fact in 1980, there were 139,487 cases of measles with 26 deaths. Even that isn't 1 per 2,000 cases. And presumably those deaths also included late-onset deaths as well.

Therefore, Peter Flegg’s basis for 750 deaths per year would indicate that this analysis came from Thomas Kuhn’s Sabre Toothed Tiger syllabus.

The reality of the years between 1952 to 1970, and afterwards, prove that Dr Flegg’s mathematical equations are about as relevant as saying that the measles death rate in Africa, is comparable to the Measles death rate in UK.

In reply to Peter Flegg’s expansion of my question to him: no, it did not occur to me that Peter Flegg would decide to include the third world when the BMJ was discussing a topic based in UK.

But since Peter Flegg wishes to compare apples with army jeeps, let's discuss his concept of that as well. Flegg states that, "in 1999 there were estimated to be 873 thousand deaths from measles, reducing to 530 thousand in 2003."

Last year, WHO (2) stated that measles mortality in Africa had slashed the death rate from measles by 91% since 2000. This 91% is an artifact figure, because before 2000, measles in Africa was "estimated", while after 2000, notifications were only accepted after being laboratory proven. In 2000, WHO implemented a system of laboratories (3) specifically to diagnose measles, and provide the laboratory confirmed cases which are now the basis of WHO data.

Look at pages 2, and 14. On page 14, 14,185 cases were reported in 2006, but after blood testing, 9,764 were "discarded". That's an immediate 69% drop in cases, because they are no longer relying on doctor's eyes.

On page 2, of 14,185 cases, 3,257 were accepted, leaving a balance of 10,928 discarded measles cases which equals 77% which were NOT measles after being blood tested, but which would have been accepted on the pre- 2000 measles notification system. Comparing data from laboratory-confirmed blood tests after 2000, with pre-2000 guessing, and then claiming a 91% decline, is not a valid scientific comparison.

Which raises an obvious issue. Peter Flegg says that clinicians caring for measles cases " would have had no doubt. Acute measles is a relatively easy clinical and laboratory diagnosis." Did (and can) UK doctors do any better than those who guessed measles in Africa before 2000, or even New Zealand for that matter? That depends on who you listen to.

An old UK newspaper article, unfortunately undated, received on 17th April 1997, reads: London (Europe Today). – "97.5% of the times that British doctors diagnose measles they are wrong", says a publication of the Public Health Laboratory service. The mistake being made by National health GP's was found when the services tested the saliva of more than 12,000 children who had been diagnosed as having measles. Roger Buttery, an adviser on transmissible diseases at the Cambridge and Huntingdon Health Department, said that the majority of doctors "say they can recognize measles a mile off, but we now know that this illness occurs only in 2.5% of the cases." Buttery says that doctors classify as measles, many other viruses that also cause spots. He found eight different viruses during the survey in East Anglia. One of them, parvovirus, gives symptoms similar to German measles. The reason for the high rate of error puzzled Buttery. "Doctors are neither vague nor careless," he said. The solution is to defer the diagnosis until more detailed information can be got. There are 5,000 to 6,000 cases of measles registered each year in the United Kingdom, but these findings now call most of them into doubt."

A later report by the same laboratory (4) showed that the most common viruses causing "morbilliform rash" in the UK are "parvovirus B19; group A streptococcus; human herpesvirus type 6; enterovirus; adenovirus, and group C streptococcus."

An editorial in an Australian medical journal (5) pointed out that:

• In Sydney, in 1990-1995 only 49% of 58 notified cases were serologically confirmed.

• In Victoria, in 1997-1998 only 8% of 248 notified cases were serologically confirmed, and for the whole of Australia in 1997 – 1998, only 45% were serologically confirmed.

• In 1994 in UK and Finland, only 1% of notified cases were serologically confirmed.

So now, doctors check for BOTH IgM (immediate antibody) IgG (evidence of past infection). If there is both IgM and IgG an enzyme immunoassay or a reverse transcriptase polymerase chain reaction is required to type the virus to figure out whether it's wild, vaccine, or whatever (6). In my files is an MMR information sheet to parents which states that neither rubella nor measles can be correctly diagnosed without a blood test. (In UK they use a saliva test.)

Therefore, according to medical literature, and information provided to parents, I would dispute Flegg’s assertion about the ability of all doctors to easily or accurately diagnose measles or rubella, without the assistance of technology. For the same reason, I also dispute the validity of comparing any historical data from 1850 with any data after laboratory data conformation was required.

However, since Flegg is presumably calculating his risk benefit analysis on potentially invalid data, I have no choice but to do the same. If the UK historical data for measles deaths is inaccurate because it too contains more “viruses” than just measles, that makes Peter Flegg’s calculations in the first paragraph, even more extravagant.

In countries like UK the decades of pre-vaccine death decline is obviously due to factors unconnected with the use of any vaccine. For the same reason, the WHO media release claiming that the measles vaccine has reduced the measles death rates in Africa by 91% between 2000 – 2007, defies logic, analysis and reason for anyone who knows the facts. I note that Peter Flegg has stopped short of repeating that spectacular assertion. Perhaps it's because even he can see the ludicrousness of such a claim.

If that is the case, the Peter Flegg fails to mention that comparative data in the UK, uses the same "mistake". Total numbers without any laboratory confirmation before 1994, cannot be validly compared with laboratory-confirmed cases only. To do so is not legitimate "science".

Peter Flegg states that, "during the last 10 years the case fatality for acute measles in the UK has been in the order of 1 in 2000".

In UK, from 1998 to 2007 (as of 24th November), there were 28,364 cases of measles.

Out of the 12 deaths from 1998 - 2007, one is known not to be measles, one is provisional, 2 were immunodeficient children within the age where vaccines are administered, and the other 8 were older deaths resulting from infections contracted prior to 1967. From the years of 1998 – 2007, the risk of any unimmunized child dying from ACUTE measles was as follows:

immunodeficient children = one per 14,182 cases of measles; healthy normal children = 0 out of 28,364.

Any suggestion that in 2008, the risk of any child dying of acute measles is 1 in 2,000 is another fictional statistical manipulation, in the same vein as: “in order for the risk/benefit equation to be tipped in favour of leaving children unvaccinated against MMR, there would need to have been more than 7500 deaths from MMR in the last 10 years.”

Peter Flegg says, "The only reason more children do not die of measles in the UK is that herd immunity is still sufficiently high to protect those who cannot or have not been fully immunised."

That is not entirely correct in my opinion.

A site called Measles Initiative says that (7), "Measles is a leading killer of children in many developing countries for several reasons. Children are already compromised with poor living conditions, they are infected at very young ages when their immune systems are not strong, malnutrition is rampant in many homes, and many families do not have access to medical care to treat measles and its complications. Measles, itself, does not kill children. Instead, complications from measles attack the child's already weak immune system. Measles attacks the body, inside and out. It is similar to HIV in the sense that when it knocks down the immune system, the child becomes susceptible to the myriad of diseases that fester in poor living conditions."

Do children in the United Kingdom have the same living conditions as children in Africa?

Peter Flegg also says, "I have no doubt that another vulnerable group (infants too young to be vaccinated) will see deaths within its ranks before too long."

Before the measles vaccine was used, it was exceedingly rare for any infant younger than 18 months to acquire measles because of the strong maternally transferred immunity and, if a mother breastfed, through the many immunological components within breast milk.

Those women in UK who now have naturally acquired measles in the last decade, will transfer solid immunity to their babies, and their babies will be unlikely to experience measles before 18 months. On the other hand, those vaccinated mothers who have not had natural measles, will not transfer that sort of immunity to their babies, and their babies might be at risk. That being the case, to blame unvaccinated children for a relatively new problem created by the use of a vaccine in the first place, is more fact juggling.

A better initiative to reduce all risks to any child from any cause whatsoever, would be to employ a certain young British chef to help start nationwide "Vitamin D, Victory gardens, exercise and cooking course" initiatives for parents and the unemployed, as well as someone else to teach "breastfeeding, home nursing and nutrition during infection". More than any vaccine, parents who provide their children with correct nutrition, enough vitamin D, sleep, exercise, and decent home nursing, can vastly decrease the annual expenditure of NHS with regard to a long list of conditions, (including potential complications and deaths from any infections).

These are conditions African parents would give their eye teeth for. If they were able to achieve even half of what the UK achieved after World War II, even without a measles vaccine, African children would have far less to fear from measles infections.

Hilary Butler. (1) http://www.hpa.org.uk/infections/topics_az/measles/nots_and_deaths.htm 

(2) Measles deaths in Africa plunge by 91% http://www.who.int/mediacentre/news/releases/2007/pr62/en/index.html 

(3) WHO, 2006 "Afro Measles Surveillance Feedback Bulletin" January 2006.

http://www.afro.who.int/measles/reports/surveillance_feedback_bulletin%20_jan_2006.pdf 

(4) Ramsay, M. et al. 2002. "Causes of morbilliform rash in a highly immunised English population." Arch Dis Child. Sep;87(3):202-6. PMID 12193426.

(5) McIntyre, P.B. et al. 2000. "Measles in an era of measles control." Med J Aust. Feb 7;172(3):103-4. PMID: 10735018. http://www.mja.com.au/public/issues/172_03_070200/mcintyre/mcintyre.html 

(6) Durrheim, D. M. et al. 2007. "Remaining measles challenges in Australia." Med J Aust. Aug 6;187(3):181-4. Review. PMID: 17680748. http://www.mja.com.au/public/issues/187_03_060807/dur10061_fm.html 

(7) Measles Initiative – The Problem http://www.measlesinitiative.org/problem2.asp

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Re: Re: In response to Peter Flegg's use of data.
 

We are trying to establish if death is more likely following acute measles infection, or following MMR vaccination. This information will help determine the risk-benefit analysis for MMR vaccination.

Hilary Butler has called my data concerning measles death rates over the last 10 years into question, so let me be more exact. Data from the Health Protection Agency reveals that from 1999 to date there have been 4027 laboratory-confirmed cases of measles (1,2). I am aware that there have been more measles "notifications" than this, but as Ms Butler says, overdiagnosis can occur and she herself seems very insistent on only counting cases of measles as valid if there is laboratory confirmation.

Over the same period there have been 2 deaths from laboratory-confirmed acute measles, ignoring the 7 deaths reported from the delayed effects of measles such as SSPE (2). This gives a case fatality from acute measles of 1 in 2014 (my original estimate was 1 in 2000).

Next we must determine the number of MMR doses given over this period, and how many have resulted in death. About 600 thousand children are born each year in the UK. Around 85% received the first dose of MMR vaccine during the last 10 years (3), and most of these will have received a second dose. This means around a million doses are given each year.

So how many deaths have occurred from MMR vaccination in the last 10 years? We await Jackie Fletcher’s information on this, but unless there are at least 5 thousand deaths minimum (equivalent to a “vaccine fatality” rate of 1 in 2000, which would be comparable to the case fatality rate from acute measles), then we can reliably conclude it is safer to get MMR vaccine than it is to get measles.

Ms Butler can talk about Vitamin D, cooking courses and “Victory gardens” until the cows come home, but the simple facts speak for themselves. It is clearly far better to have MMR than to go without.

(1) http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733833790 

(2) http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1227774028888 

(3) http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733819251 

Send response to journal:
Re: Incorrect URL.
 

Dear Sir,

In my previous response, the URL for the measles cases and deaths data has changed since I printed it out last year.

The correct URL is now:

http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1195733835814?p=1191942172799 

Hilary Butler.