This is the text of my third submission on behalf of Age of Autism to the House of Commons Science and Technology Committee Inquiry into Research Integrity last April, which has gained extra urgency because of the debate about compulsory vaccination. Though two earlier submissions could have been excluded because of submission criteria, there were no obvious grounds for excluding this one, except that like the others it tackled the core claims of their discussion document head on - that the 1998 Wakefield Lancet paper was an example of research fraud, or that it should be considered inherently reprehensible on the grounds that it subverted policy. The one thing that became apparent in my brief discussions with the secretary to the committee, Mr Fiander, was that the committee would stand by its claim of fraud simply because the claim had been made in a British Medical Journal editorial in January 2011 which had never been retracted (despite overwhelming evidence against it claims). The committee itself was dissolved without the inquiry proceeding at the time of the General Election and has not yet been re-formed.
This evidence has been shaped by statements made in the Committee’s prior publication POSTnote 544 singling out the Wakefield “Lancet paper” as an example of fraud, and particularly in relation to the defence of a public health programme and policy . It becomes particularly relevant in the light the latest campaign in February 2017, led by Times Newspapers, to further discredit Andrew Wakefield [2,3].
This submission is not motivated by indifference to the control of infectious disease. While the control of disease is important it is not a good enough reason to stand the rules of research integrity or public discussion on their head. This is not only about the Wakefield paper but the problematic nature of vaccine science, and also the general exclusion of the subject from contemporary mainstream public debate. Even the reasons for going to war at times of national peril are debated, but here it is as if everything has been conceded in advance to an industry and its public advocates. In these circumstances reasonable comment is driven to the margins with unreasonable, even to the extent of being buried by search engines such as google.
It is also problematic that virtually every public defence of the vaccine programme begins with an attack on the integrity of Dr Andrew Wakefield, as if the public humiliation of one man could provide scientific justification in perpetuity for an entire class of products. Wakefield has been globally transformed into the Emmanuel Goldstein of public health (to reference Orwell’s 1984) but we should not mistake that this is actually occurring at the level of propaganda and not of scientific (or historic) fact: indeed when people cite Wakefield as an example few have the remotest idea what body of facts they are citing, and this has reduced to zero the quality of informed public discussion.
Meanwhile Wakefield’s fate serves as a warning to anyone else who might professionally step out of line over vaccines. In this context it is necessary to pose the question in what other field of human activity would this means of controlling public discussion and opinion be considered politically tolerable or enlightened? Vaccines are just industrial products and it is short-circuiting safety systems if there is overwhelming hostility led from top down to reporting and investigating their adverse effects. Governments have too much invested in the reputation of program and presently they do not incorporate the appropriate checks and balances to investigate themselves. Whatever monitoring of programme takes place comes from the same agencies that license and promote the products.
Following the original set of allegations were launched against Wakefield in February 2004 politically charged prejudicial statements were made to the media by both Chief Medical Officer, Sir Liam Donaldson, and the Prime Minister, Tony Blair [4,5].
There is much evidence that the Wakefield paper should have been restored and the editorial by Godlee et al (along with the investigative reports by Brian Deer, which it accompanied it) should have likewise been retracted. It is troubling Postnote544 should revert to the situation in January 2011 when the position unravelled in the months that followed. Dr Godlee made concessions that the author of the BMJ report, journalist Brian Deer, was working from different data to that available to the study authors  and that the journal ought to have acknowledged it business association with MMR manufacturers Merck and GSK . Matters came to a head in November 2011 when Dr David Lewis – in a lengthy submission which the BMJ published in part - produced print outs of the biopsy slides confirming the paper’s findings, and serious concessions by Godlee and Deer were made in a news report in Nature [8, 9]. A letter was published in the BMJ from senior histopathologist from the paper, Dr Amar Dhillon , standing by the results making it clear that the biopsy results were determined independently of Dr Wakefield (and his colleague Dr Susan Davies  had already written to journal repudiating Deer’s account the preceding year). In the absence of further evidence supporting the BMJ account it was perhaps more than time their allegations were retracted. However, their case became even problematic in March 2012 when the High Court fully exonerated the senior author of the Wakefield paper (and senior clinician), Prof Walker-Smith. Since Prof Walker-Smith had as much responsibility for reporting in the paper as Wakefield, and was responsible for compiling the medical histories in 11 out of 12 cases there could be no question of Wakefield tampering with evidence . The final nail came later that year when University College London refused to conduct an inquiry into the affair for lack of evidence .
In the United Kingdom there is overwhelming institutional bias against recognising vaccine damage. In 2007, after the tragic death of Sally Clark (wrongfully found guilty of the murder of her children 1999) Neville Hodgkinson reported in the Spectator :
An examination of related legal and other correspondence has now made clear the reason for this extraordinary omission. It is that child health experts, following public loss of confidence in vaccination when the risks of brain damage were first publicised, were trying to maintain a united front in preventing further debate. Even paediatricians who gave testimony on Mrs Clark's behalf told defence lawyers that if vaccination were mentioned as a possible cause of Harry's death, they would dispute it. Not wanting to confuse the jury, and with judges having a history of bowing to dominant medical opinion, the defence decided to stay silent on the issue.
Yet the reality is that product inserts and data sheets acknowledge the possibility of serious injury. On the other hand any doctor giving testimony about such a matter (which would be perfectly acceptable, for example, in a United States court) would likely face retribution at the General Medical Council. The Wakefield paper poses an existential question about the way the vaccine programme is run in the United Kingdom which is, what would happen if doctors started, or in practice were allowed, to even consider the possibility of vaccine damage? This is also implicit in POSTnote 544: the fact that the Wakefield paper had challenged policy.
The result is that we have a system which is not entirely honest about risk and which places the control of infectious disease way above the potential for harm (for instance neurological) from an expanding vaccine schedule. A serious problem with this is that the better the system becomes at suppressing the harms of vaccines the harder it is to actually know what is going on. Spontaneous reporting is not a good way of assessing levels of damage, and even less so if any attempt to do so is likely to be met with extreme institutional and social hostility. But quite apart from the atrocious injustice to those that are hurt there may be an ever increasing burden to society.
In this regard the Department of Health have neglected to collect autism figures for children since the middle of the last decade while the figures for schools – available from the Department of Education – continue to rise year on year (the rate being easy to calculate from published data by dividing the number of children in school by the number with an ASD diagnosis). These figures only give a rough idea and are an underestimate of the rise because (a) they are based on a 15 year cohort – which with a continuously rising trend means that autism is likely to be much more prevalent at the younger end of the group – and (b) not all cases will have yet been diagnosed (the Baron-Cohen paper having indicated this might happen on a 2:3 basis). Bearing this in mind we may not be far off population catastrophe. In England, as of January 2016 there was a figure of 1 in 71, while in Scotland in September 2016 it was 1 in 51, but with younger children we may easily be dealing with double that rate or beyond, and again for boys the rate is far higher. If, conservatively, the rate among younger children was 1 in 30 in Scotland, this would mean as many as 1 in 19 boys.
In 2009 a DH/National Statistics survey conducted by Prof Brugha and colleagues declared that there was an adult autism rate in line with that discovered in children c.2004 . However, the methodology was flawed: a non-standard and untested diagnostic method was used (adapted from ADOS 4) and even then the 19 cases diagnosed required an unexplained weighting method multiplying the figure by 3.8 to arrive at the 1% (i.e. they projected that they had missed 74% of the cases in the original survey, but no evidence was presented for this). The 1% figure was then used at an NHS press conference to the media as evidence that MMR was safe. For example, a report by Guardian science correspondent Sarah Boseley was entitled “Autism just as common in adults, so MMR is off the hook” . Whatever their case the 1% has now been left miles behind by what is now happening in schools.
Presently, in reports from Scotland  and Northern Ireland , we are hearing about the insufficiency and breakdown in services, but we are not being told that the likely reason is unprecedented demand . Patently, it is also not the services creating demands they cannot cope with, and nor is it only autism – ADHD seems much on the rise as well. While we have a lot of policy emphasis on threats from infectious disease the rise in neurological impairment is barely being reported on at all and its causes are not being investigated. Troublingly, the Department of Health has not repeated the Childhood Mental Health Surveys of 1999 and 2004 [19, 20] which would expose this desperate and unexplained situation, effectively freezing the childhood figure at the 1% figure it was last recorded at 13 years ago. Indeed, the two published surveys of 1999 and 2004 had already indicated a five-fold recorded increase in autism in children born between the two periods 1984-8 and 1994-9. MMR was introduced just at the end of the first period, an accelerated DPT schedule in 1990 and HiB in 1992 in between. If the rate of autism is possibly three times higher among younger children now than in 2004 we should perhaps also at least consider how far the vaccine schedule has expanded in the intervening years for a child entering school:
8 weeks: 5-in-1 vaccine: diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b, 13 Strain Pneumococcal, Rotavirus, Men B
12 weeks: 5-in-1 vaccine, Rotavirus vaccine
16 weeks: 5-in-1 vaccine, 13 Strain Pneumococcal, Men B
One year: Hib/Men C vaccine, MMR, 13 Strain Pneumococcal, Men B
2-7 years (including children in school years 1, 2 and 3)
Children's flu vaccine (annual)
3 years and 4 months: MMR, 4-in-1 pre-school booster: diphtheria, tetanus, pertussis, and polio
Irrespective of the reasons for not updating the survey this represents a distortion of policy and institutional negligence.
Insufficient attention has been paid to the viability of the expanding schedule. A 2015 publication by United Kingdom vaccine programme veteran, Prof Elizabeth Miller referred in defence of the expanding schedule to “strong arguments against the immune overload hypothesis” . The “immune overload hypothesis” may itself be a straw man but the reference as far as one can tell is to a 2002 paper by Offit et al repeatedly cited by British health officials since its publication[22,23,24,25], justifying multivalent vaccines and the expanding schedule. Offit argued a hypothesis of spare capacity, notoriously suggesting that an infant could tolerate at least 10,000 vaccines in one go based on the number of antigens. But apart from anything else the number of antigens is only a single element in what would make a vaccine effective. In most cases, for example – MMR is an exception – vaccines include adjuvants which amplify the effects of the antigens. This problem is currently highlighted in a complaint by Nordic Cochrane about HPV vaccines: it is noted that the vaccines were not trialled against genuine placebo, but vaccines containing aluminium adjuvants, the effects of which have not been sufficiently studied .
Clearly vaccines insofar as they work do so by creating inflammation, are most often delivered by injection in a single instant and this again is different from Offit’s point of comparison which is casual daily exposure to antigens through food or dust . It is evident that most/all vaccine package inserts acknowledge the potential for serious harm in rare instances, but we may have relatively little idea of how often without active long term monitoring. Again vaccines may have routinely unpleasant immediate effects: 6 in 100 toddlers receiving MMR according to one study had a temperature of 39.5C or above but there was no follow up after a month . According to the FDA information sheet for for Bexsero Men B vaccine, now given to UK infants, 10-25 year-olds had “serious adverse events” in above 1 in 50 cases . These are anything but the subliminal effects which would seem to be implied by the Offit model. There does not seem to be any core, substantial science to the belief that the schedule can go on expanding without significant harm – Age of Autism has not seen any cited. Over such a serious matter for our children we need much more than the “strong arguments” suggested by Prof Miller: in fact “strong arguments” falls well short of being evidence at all.
In the case of autism US health officials have occasionally obliquely acknowledged causation by vaccine. In 2008, Julie Gerberding, Director of the Centers of Disease Control told CNN :
Now, we all know that vaccines can occasionally cause fevers in kids. So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism…
And health officials disclosed on separate occasions to journalists Sharyl Attkisson and David Kirby [31,32]:
The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines. We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.
Amid the Wakefield furore in 2005 the main text (in contradistinction to “the plain language summary”) of the Cochrane report on MMR safety was anything but reassuring: the “design and reporting” in MMR safety studies was “largely inadequate”. None of the six autism related studies was rated as being at “low risk of bias”, and there were serious design faults in all. Pertinent questions might be “why?” and “why is this acceptable?” In the case of the DeStefano (2004) study which was later to become the subject of Wakefield’s film VaXxed Cochrane presciently warned [33, 34]:
The conclusion, however, implied bias in the enrollment of cases which may not be representative of the rest of the autistic population of the city of Atlanta, USA where the study was set.
Indeed, one of the main authors, Dr William Thompson, attempted to blow the whistle on the paper in 2014 in a statement through lawyers :
I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.
Vaccines are a very tempting answer to the problem of infectious disease but it may be even easier than with many policies for politicians to ignore the downside of policy and leave it to the professionals. The book Don’t Tell the Patient by a former senior Department of Health official and founder of the yellow card scheme, Dr Bill Inman, reported how very few of the severe injuries from the old DPT vaccine ever got recorded. He states that from his data analysis it was at least ten times higher than the 1 in 300,000 that the Department of Health “was clinging to”. He noted :
Children who had developed a temperature or had screamed repeatedly or had muscular spasms or convulsions after the first injection, had sometimes been given further doses of the vaccine with catastrophic results.
Another former Department of Health official told me that he had been to consult Sir Richard Doll who told him that the only way to assess the real level of damage in the population would be to actively monitor all the vaccinated for adverse events and sequelae, and this was not done. A study published this year showed that introduction of the vaccine in Guinea-Bissau in 1981 was associated with 5 times higher mortality rate in infants . It has proved terribly easy to sweep such things under the rug.
In 2009 the government slipped on to the statute book a law requiring the Secretary of State for Health to follow the advice of the JCVI . In 2014 the JCVI under the chairmanship of Prof Andrew Pollard recommended to the infant schedule the Men B vaccine Bexsero , a controversial vaccine [29,40,41,42] of which he himself was the lead developer . The Cochrane complaint about the EMA also names Prof Pollard :
There were no restrictions for the chair of the meeting, Andrew Pollard, although he had declared several conflicts of interest in relation to the HPV vaccine manufacturers GlaxoSmithKline and Sanofi Pasteur MSD until 2014 and 2013, respectively.
Whether or not Prof Pollard’s name appears on contracts he remains Director of Oxford Vaccine Group  which develops vaccines. It may be time for politicians to take an interest in such matters again.
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