Andrew Wakefield
What are you like, old chap?
"Callous Disregard" - The Book By Wakefield
Highly recommended in order to get Wakefield's take on things.
You should read it even - especially - if you are convinced of all the worst things his most extreme opponents say about him - it's always good to try and get the other point of view.
If you don't want to give him the royalties, you can always buy it second-hand.
Urabe
A crucial part of Wakefield's view on MMR is that its safety record, rather than being "exemplary" as the UK govt put it, is actually terrible. The story of use of the Urabe strain in UK measles vaccinations is a cornerstone here, so it is worth its own section: Mumps
"That Paper"
Here's the crucial point at issue around the paper: which of the following is true?
- Wakefield was carrying out clinical investigations using justified procedures, which he then perfectly properly wrote up as a case study
- Wakefield was carrying out an unauthorized research program aimed at establishing evidence behind a pre-conceived thesis, which he then misleadingly presented as case study arising from routine clinical investigations.
The main distinction between research and clinical investigation being:
- research medicine: prime purpose of testing an hypothesis
- clinical medical practice: undertaken with the intention of benefitting the individual patient
Ultimately this turns in large part upon trying to assess people's intentions - never easy. So which interpretation people find most convincing will depend on what they already think about Wakefield. It is worth noting that the judgement of Justice Mitting of 07Mar12 that exonerated Wakefield's colleague Walker-Smith states clearly that Mitting thinks Wakefield's purpose "was undoubtedly research".
There are other divergencies around funding, conflicts of interest, etc - but these are really just distractions, whose interpretation depends even more on what people already think of motives and morals. For me the central point is whether Wakefield's paper was research dressed up as clinical case studies. Wakefield himself clearly firmly believes the latter - the case study view.
Did The Paper Say MMR Caused Autism?
No.
It was careful to point out that no association was proved between MMR and (autistic) syndrome.
(Quite correctly: the number of children involved was too small to talk of proof of any such thing - Wakefield himself certainly accepts this).
The finding was: "We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers."
Eg a temporal correlation, the environmental trigger being MMR in 8 of the 12 children concerned.
But Wakefield gave 26Feb98 conference on back of it recommending mono rather than poly vaccine. Why?
A report of the press conference, Independent, 27 Feb 98
It would be interesting to know more about how Wakefield had come to form his view on the dangers of polyvalent vaccines. "Callous Disregard" does not go into detail here, other than referring to a 250-page doc of other evidence.
Summary of std view of whether vaccines cause autism: [1]
The Measles Vaccination Gap
Did Wakefield Criticse MMR When No Single Vaccine Alternative Was Available?
It depends on your viewpoint whether you say "yes" or "no" to that. Wakefield honestly does not believe that this is a fair statement of his position. The vaccine establishment honestly believe that it is a fair statement.
Single Vaccine was available in the UK from Pasteur Merieux at the time Wakefield gave the Feb 1998 presentation. There just wasn't very much of it.
The single-dose measles vaccine was available on a "named patient basis" - to allow vaccination against measles for specific patients with medical issues against other components of MMR. It was only available in relatively small amounts, and indeed stocks had run out less than a week after the Lancet paper was published - by 5th March Pasteur Merieux said they had run out and would have no more before June.
Then later (end-Aug 98) Pasteur Merieux withdrew the single dose vaccine from the UK entirely saying they could not engage with the UK demand and wanted not to be in the position of picking and choosing who in the UK got the single jab.
So while the single measles jab was available on a "named patient basis" it was not a viable alternative route for UK vaccination at the time Wakefield gave his presentation - and then shortly afterwards was not available at all.
But it was in existence and its production could have been scaled up if the DoH had backed doing so and if the vaccine manufacturer had agreed to supply it.
To summarise:
- At the time of Wakefield's Feb 1998 paper you could get single dose measles in the UK - it did exist
- But existing stocks of single dose measles vaccine were very small - in the hundreds
- 5 days later you could not get single dose measles in the UK - stocks had run out, that's how low they were
- Pasteur Meriuex could have ramped up production but this would have required government commitment to buy
- Whether you class this as "being available" depends on your view of Wakefield's paper and what people should have done in response to it
Who Is Responsible For The Measles Vaccination Gap?
Your opinion on this will depend who you think is right over whether Wakefield's Feb 1998 should have changed government policy over MMR.
Argument for "Wakefield is responsible"
- Wakefield recommended UK-wide replacement of MMR by annually spaced single vaccines that were only supplied in very small volumes, eg a few hundred shots for the whole of the UK (for people with a genuine reason not to take MMR).
- Less than a week after Wakefield's Feb 1998 conference, panic meant that single-shot stocks ran out and more were not available until June.
- Even if the DoH had made a strong committment to buy single vaccine in bulk, the company would have been very reluctant to comply, since its own policy was that MMR was a better way to distribute a measles vaccine.
- Wakefield must have known that the company would not in practice make the single vaccine available without a complete volte-face from the DoH, and that this was hardly likely.
- The vaccine manufacturer eventually withdrew the single vaccine entirely from the UK since the UK demand was not possible for it to fulfill while still acting in what it considered an ethical fashion.
- Wakefield is therefore responsible for the vaccination gap.
Argument for "The UK Government is responsible"
- Wakefield recommended single-shot vaccines that could easily have been supplied in sufficient volumes if the UK government had correctly acknowledged the risk of combining vaccinations, and had worked with the vaccine manufacturer to make single shots available.
- But instead the manufacturer withdrew the single shots from the UK entirely, despite the hugely increased demand for single shots.
- Why would it do so? Because the UK governemnt actively pressured the company to stop making the single vaccine available in the UK - Wakefield certainly has this interpretation, saying "the British government withdrew the importation licence for the single vaccines" (statement in "The Independent", 12Apr13)
- The UK government is therefore responsible for the vaccination gap.
Timeline And Press Reports
27 Feb 1998: Press conference reported
Doctors warn of a new child vaccine danger
- The Independent
- Jeremy Laurance, Health Editor
- Friday 27 February 1998
DOCTORS have discovered a new childhood disease which could be linked with a vaccine given to 600,000 children a year. The disease, marked by an unusual inflammation of the gut, is associated with autism and could provide a clue to the origins of the devastating disorder which results in social withdrawal and difficulties in communication.
Researchers at the Royal Free Hospital in north-west London, who have studied 12 children with the syndrome, say that in eight the symptoms appeared soon after vaccination with MMR which is given at age 12 to 15 months to protect against measles, mumps and rubella. They claim to be the first in the world to identify the syndrome which they say has emerged since the start of the vaccination programme in 1988.
However, at a press conference called by the hospital yesterday to publicise the findings, published in the Lancet, doctors were divided about the implications. Most of those involved in the study say MMR vaccination should continue, but Dr Andrew Wakefield, leader of the team, said that it should be divided into its three component parts and given separately.
The hypothesis is that the combined vaccine delivers a jolt to the child's developing immune system which could be reduced if it were divided. Dr Wakefield said: "Vaccination should continue, but it will put children at no further risk if it is dissociated into three."
A commentary in the journal, which is sceptical about the study, says the link with MMR has not been proved and warns of a "social tragedy" if the public shuns immunisation. The first symptoms of autism commonly appear in the second year of life, about the time MMR is given, leading to the possibility of a false association. Before immunisation against measles was introduced, the disease killed around 90 children a year.
Dr Simon Murch, paediatrician and co-author of the paper said there was insufficient evidence to justify a switch to single vaccines. "The link is unproven and measles is a killing infection. If this precipitates a scare and immunisation rates go down then, as night follows day, measles will return and children will die."
5 Mar 1998: Stocks run out
Child-vaccine setback for worried parents
- The Independent
- Jeremy Laurance, Health Editor
- Thursday 05 March 1998
PARENTS demanding single vaccines for their children because of fears about the safety of the combined MMR jab against measles mumps and rubella are being told that stocks are exhausted and there are no plans to provide more.
A study last week which suggested a possible link between MMR vaccination and bowel disease and autism has triggered hundreds of calls to vaccine- damage support groups. Dr Andrew Wakefield, the chief author of the study, published in the Lancet last week, advised parents to administer the three vaccines one at a time - with at least a year's gap between each - to reduce the impact on the immune system, although other members of the research team said use of the combined vaccine should continue.
Yesterday, Pasteur Merieux, makers of MMR, said most of their measles vaccine was used to make the combined MMR to satisfy the worldwide demand and they only kept "a few hundred doses" of the single vaccine. It was currently out of stock and new supplies would not be available until June.
A spokesman said over 250 million doses of MMR had been given worldwide over 26 years. "If there was a problem with MMR I think we would be aware of it by now."
End-Aug 1998: Withdrawn by makers
Measles jab withdrawn due to 'high demand'
- The Independent
- Andrew Buncombe
- Tuesday 01 September 1998
Last night Pasteur Merieux MSD, the Paris-based company that makes both the triple and single vaccines, said the single vaccine had been available in Britain on a named-patient basis only.
"That meant it was only available to a very small number of people," said Dr Veronique Maguin, the company's marketing director.
"As demand grew we had to make an ethical decision about who the drug should be available to. It was a problem for the company because we could not satisfy everybody. Our main concern is one of public health and we felt we could not satisfy everybody."
Note: On the same day The Independent also had a leading article (editorial) asking for the DoH to work with the manufacturers and get a single vaccine to be made available. Obviously this was not the way things turned out.
Striking Off
GMC
The crux: was Wakefield carrying out research or treating patients? Everything hangs on this in the GMC judgement. Both the GMC and the judge who later exonerated Wakefield's partner (Walker-Smith) state very firmly that Wakefield was carrying out research. Wakefield is equally firm that he was treating patients and writing up a case study.
In September 1996 Dr Wakefield made an application to the Ethical Practices Sub-Committee of the Royal Free Hospital (Ethics Committee) seeking approval for a research project involving 25 children. This was approved by the sub-Committee as Project 172-96. He named himself as one of the three Responsible Consultants, thereby taking on the shared responsibility for the information given in support of his application; for ensuring that only children meeting the inclusion criteria would be admitted to the study; that conditions attached to the Ethics Committee approval would be complied with; and that children would be treated in accordance with the terms of the approval given.
In respect of Research and Ethics Committee approval, the Panel had regard to the particular ethical guiding principles with regard to conducting research on children. It rejected Dr Wakefield’s overall contention that Project 172-96 was never undertaken; that all the investigations carried out on the children were clinically indicated and that the research elements of the project were covered by another Ethics Committee approval.
The Panel concluded that the programme of investigations that these children were subjected to was part of Project 172-96. It further determined that the conditions for approval and the inclusion criteria for that project were not complied with. The Ethics Committee’s reliance on the probity of Dr Wakefield as a Responsible Consultant was not met.
With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.
The results of the research project were written up as an early report in the Lancet in February 1998. Dr Wakefield as a senior author undertook the drafting of the Lancet paper and wrote its final version. The reporting in that paper of a temporal link between gastrointestinal disease, developmental regression and the MMR vaccination had major public health implications and Dr Wakefield admitted that he knew it would attract intense public and media interest. The potential implications were therefore clear to him, as demonstrated in his correspondence with the Chief Medical Officer of Health and reports which had already appeared in the medical press. In the circumstances, Dr Wakefield had a clear and compelling duty to ensure that the factual information contained in the paper was true and accurate and he failed in this duty.
The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96 and the purpose of the project was to investigate the postulated new syndrome following vaccination. In the paper, Dr Wakefield failed to state that this was the case and the Panel concluded that this was dishonest, in that his failure was intentional and that it was irresponsible. His conduct resulted in a misleading description of the patient population. This was a matter which was fundamental to the understanding of the study and the terms under which it was conducted.
In addition to the failure to state that the children were part of a project to investigate the new syndrome, the Lancet paper also stated that the children had been consecutively referred to the Department of Paediatric Gastroenterology with a history of a pervasive developmental disorder and intestinal symptoms. This description implied that the children had been referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral process. In fact, the Panel has found that some of the children were not routine referrals to the gastroenterology department in that either they lacked a reported history of gastrointestinal symptoms and/or that Dr Wakefield had been actively involved in the process of referral. In those circumstances the Panel concluded that the description of the referral process was irresponsible, misleading and in breach of Dr Wakefield’s duty as a senior author.
The statement in the Lancet paper that investigations reported in it were approved by the Royal Free Hospital Ethics Committee when they were not, was irresponsible.
Subsequent to the paper’s publication, Dr Wakefield had two occasions on which he could have corrected the content of the Lancet paper yet both times he compounded his misconduct.
First, in a published letter in response to correspondents who had suggested that there had been biased selection of the Lancet children, Dr Wakefield stated that the children had been referred through the normal channels, a response which was dishonest and irresponsible. He provided an inaccurate statement which omitted relevant information when he knew that the description of the population in the study was being questioned by the scientific community.
Second, at a meeting of the Medical Research Council, the Chair, Professor Sir John Pattison referred to the seriousness and importance of the implications of Dr Wakefield’s research and its major public health implications. At that meeting and on the issue of bias in generating the series of cases, Dr Wakefield stated that the children had come by “the standard route”, a response which was dishonest and irresponsible.
Does Professor Walker-Smith's Exoneration Help Wakefield?
Mitting judgement quashing Walker-Smith's striking off of 27Mar12
No.
See quote below where Justice Mitting clearly states that he thinks Wakefield is the wrong side of the line - the relevant part is in emphasis.
16. Given that conclusion, it is neither necessary nor desirable that I should express a dogmatic view about the meaning of the guidance. I understand the GMC’s concern that a purely subjective test would significantly water down the obvious requirement for medical research to be approved and monitored by Ethics Committees: if the intention of the practitioner is the sole or even principal determinant, that undesirable result may occur. The control mechanism is to be found in the second requirement in paragraph 2.2 for medical practice – there must be a reasonable chance of success. That test is objective, even if qualified by the Bolam v. Friern Hospital Management Committee [1957] 1WLR 582 principle, but it cannot resolve all difficulties. When the person undertaking the activity has two purposes or when different people participating in the same series of activities have different purposes, it may be very difficult to say into which category the activities fall. This difficulty is particularly likely to arise in activities undertaken by an academic clinician and/or in a teaching hospital with a research department. These difficulties arose in this case: Dr. Wakefield’s purpose was undoubtedly research; Professor Walker-Smith’s may have lain anywhere on the spectrum. It was for the panel to determine where it did; but first, it had to determine what his intention in fact was.
Offit's View
From "Paul Offit on the Dangers of the Anti-Vaccine Movement", 27Apr2011
Dr. Offit: He's an interesting guy, Andrew Wakefield. What he did was he published a paper in 1998 in a general medical journal called The Lancet, which is a very well-respected journal. It was really a case report. It was a case series of 8 children who had recently received the combination measles, mumps, rubella vaccine or MMR vaccine. They all, according to the parents, had developed symptoms and signs of autism within a month of receiving that vaccine. He also believed that when he looked by endoscopy at their intestines that they had something called ileal lymphoid nodular hyperplasia, which is to say, a swelling of groups of lymphoid tissue like the Peyer's patch or mesenteric node.
He believed he had found something. He believed he identified an important syndrome. Get the MMR vaccine, develop intestinal symptoms, and then get autism. Now, that was wrong --
Dr. Adashi: Based on 8 cases.
Dr. Offit: Based on 8 cases. Obviously, to his credit, in the discussion section of that paper he actually said, I cannot say that this vaccine caused autism because this is not a controlled study; I haven't looked at large groups of children who did or didn't receive the vaccine. He did say that in the discussion section, but that was the last time he said it. I mean, the next day with the lights shining and the cameras rolling, he said exactly that -- that he feared the MMR vaccine caused autism.
Now what is interesting about Dr. Wakefield is a few things. One is that since that study or that case series was reported there have been many, many studies -- about 14 -- that looked at large groups of children who either did or didn't receive MMR to see whether the risk for autism was greater in the vaccinated group. Clearly, it wasn't -- again and again and again. What makes Dr. Wakefield interesting is that he simply holds onto this belief. It's like a religious belief, which is remarkable for a scientist, and that's why he can do so much damage. He's convincing because he's convinced. I've never seen anything like him.
In many ways, though, he has actually helped the cause of getting good information to the public. What has since been found out is that much of what he had published was fraudulent -- that he had misrepresented those cases and that he'd misrepresented the so-called PCR data looking at measles virus genome in the intestines. That, in fact, 5 of the children in that paper (actually their parents) were in the midst of suing pharmaceutical companies. He received hundreds of thousands of pounds from a personal injury lawyer to arguably make their claims more valid by publishing it in a paper.
When the fraudulent nature of that paper came out, it did a lot of harm to the anti-vaccine movement because people saw it as fraudulent.
Dr. Adashi: As we speak about it today, where do Dr. Wakefield's claims stand?
Dr. Offit: They're on the fringe. They're gone. There is no mainstream reporter who carries this as fact anymore or even a controversy. I think because he was found to be fraudulent he's been dismissed, which is a little upsetting in some ways, because it doesn't matter whether he was wrong or whether he was wrong and fraudulent. It really only matters that he was wrong. I think people more easily dismiss him because he was also fraudulent, but the fact that he was wrong, and studies have shown that he was wrong, should have been enough. It seemed that the fraud made it easier to dismiss him.
Dr. Adashi: Has Dr. Wakefield ever gone beyond those 8 cases? Has he published follow-up papers, a larger number of cases, controlled studies of any kind?
Dr. Offit: Controlled studies, no. I mean, he has published a larger number of cases in what he believes to be a syndrome, but his syndrome has not been supported by large, excellent, controlled epidemiologic studies. He was wrong. MMR doesn't cause autism. It never made sense that it did, and now we know that it doesn't. Yet he still holds on to this fact. Now he's in Minnesota trying to talk to these Somalis who are in the midst of a measles epidemic. It's all just so horribly unconscionable and hard to watch.
Wakefield's View
statement in "The Independent", 12Apr13
In the wake of further media distortion, misrepresentation, and ignorance in relation to the measles outbreak in Wales, it is important to clarify some key facts.In 1998, following an analysis of all published pre-licensing studies of MMR vaccine safety I recommended the use of single measles vaccine in preference to MMR. This remains my position.
At that time, in contrast with the false assertions of many commentators, including Richard Horton, Editor of The Lancet, and vaccine millionaire Paul Offit, the single vaccines were licensed in the UK and freely available to the British public.
While MMR vaccination uptake fell from February 1998, there was a reciprocal increase in the uptake of the single vaccines – a fact that is never acknowledged in the press. Vaccination clinics administered many thousands of doses of measles vaccine and children were “protected”.
Six months later, in September 1998, the British government withdrew the importation licence for the single vaccines, effectively blocking this option for parents.
Measles cases in the UK rose when the government withdrew the importation licence for the single measles vaccine leaving concerned parents with no choice. When I demanded to know why, if the government’s principal concern was to protect children from measles, it would prevent parents with genuine safety concerns over MMR from protecting their children, Elizabeth Miller of the Health Protection Agency responded, “…if we allowed parents the choice of single measles vaccines it would destroy our MMR programme.” The government’s concern appeared to be to protect the MMR programme over and above the protection of children.
Despite the claim of David Salisbury, head of the UK’s Immunisation Division, that MMR has, “an exemplary safety record”, two of the three brands introduced in 1988 had to be withdrawn for safety reasons – they caused meningitis.
Government officials had approved these dangerous vaccines – Pluserix and Immravax – giving them the great majority of the UK market despite knowing that they were high risk and despite having been warned explicitly of their dangers. These government officials put price before children’s health and have been seeking to cover up this shameful fact ever since.
The US government has paid out millions of dollars to children whose autism followed vaccine-induced brain damage. A recent government concession in the US Vaccine Court confirms that the parents’ claims were valid all along. In a recently published December 13, 2012 vaccine court ruling, hundreds of thousands of dollars were awarded to Ryan Mojabi, whose parents described how “MMR vaccinations”, caused a “severe and debilitating injury to his brain, diagnosed as Autism Spectrum Disorder [‘ASD’]”.
Later the same month, the government suffered a second major defeat when young Emily Moller from Houston won compensation following vaccine-related brain injury that, once again, involved MMR and resulted in autism.
The cases follows similar successful petitions in the Italian and US courts (including Hannah Poling, Bailey Banks, Misty Hyatt, Kienan Freeman, Valentio Bocca, and Julia Grimes) in which the governments conceded or the court ruled that vaccines had caused brain injury. In turn, this injury led to an ASD diagnosis. MMR vaccine was the common denominator in these cases.
The more light that shone on this subject by way of informed, balanced debate, the better. I am offering to debate any serious challenger on MMR vaccine safety and the role of MMR in autism, live, in public, and televised