Vaccine - Autism Link Doctor Guilty of Misleading Conduct

Some rather damning evidence has been brought forwards regarding Andrew Wakefeild, the Doctor that performed the studies that suggested a link between vaccination and childhood autism.

His research is what spurred on people like Jenny McCarthy and many others to join the anti-vaccination movement.

Ten of his co-authors have repudiated his work and there are apparently a number of ethics violations involved as well.

Strangely he also had a financial interest in a MMR Vaccine in development

More info over here

Vaccine-Autism Doctor Guilty of ?Dishonesty and Misleading Conduct? : Discovery News

http://www.telegraph.co.uk/health/70...d-callous.html

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Standing outside the General Medical Council yesterday, surrounded by crowds of supporters, Dr Andrew Wakefield appeared shell-shocked by the GMC’s damning findings that he had been “dishonest, irresponsibile and showed callous disregard for the distress and pain of children.” Rallying some of his usual bravado, he then declared himself “resolute and determined” in the face of disgrace.

“I still had a naive belief in justice, I didn’t believe it could be quite like this,” he told me when the hubbub had subsided. “I feel so sorry for the children and their parents, it’s desperate for them. But the struggle goes on. The chap who discovered Thalidomide said this always happens and fifty years later he received an apology.”

For two and a half years a panel has been listening to arguments about whether Wakefield, and two erstwhile colleagues from the Royal Free Hospital in London – Professor John Walker-Smith and Professor Simon Murch – were guilty of unethical behaviour in the way they conducted research. At the heart of the case lies a 1998 paper, published in the medical journal The Lancet: a study of 12 patients with autism and bowel disease which might have been linked to the MMR (measles/mumps/rubella vaccine. Its publication, and the views expressed by Wakefield, a gastroenterologist, at the press conference afterwards, led to widespread panic about the safety of MMR.

The conduct of the study – not its conclusions – has been the subject of the hearing, but the paper was a landmark in the debate surrounding the safety of vaccines. It created the panic that led to a drop in uptake of the MMR, which now stands at 78 per cent, and a subsequent rise in cases of those diseases. Last year in England and Wales there were 1,143 cases of measles, which can lead to brain damage and death.

Long before the GMC concluded that Wakefield had “failed in his duties”, he was a villain to many within the medical establishment – an arrogant doctor who published his findings too soon, a man whose reputation mattered more to him than public panic and herd immunity. In 2004, 10 of the 13 authors dissociated themselves from a paper which the editor of the Lancet, Richard Horton, described as “fatally flawed”.

But to the parents who wept outside the GMC today, Wakefield is a hero, a wronged man. Among them was Polly Tommey, founder and editor of The Austim File, a magazine whose readership of 40,000 consists of parents whose children have autism combined with bowel problems. They are looking for explanations and cures. Wakefield, to them, represents hope, and it is in Tommey’s west London home that Wakefield invited me a week ago, because he wanted to explain his case.

His mood then was considerably more bullish than yesterday. Far from feeling contrite, or admitting to nerves, he was on the attack. His targets were the Government, Public Health supremos (with capital letters he later emails to make clear), the press in general and Brian Deer in particular – the journalist whose three letters of complaint to the GMC had led to the longest, and most costly, trial in that organisation’s 148-year history.

For a man who has been under intense pressure since 1998, he appeared unlined for his 53 years. In 2001, he lost his job at the Royal Free, and moved to America while his wife Carmel, also a doctor, and their four children, currently aged from 21 to 12, stayed behind in England. They joined him three years later, once he had established Thoughtful House, a research and treatment centre, in Austin, Texas. “It has been pretty terrible,” he admits and his face briefly takes on a vulnerable look, but he does not wish to dwell on personal matters.

Wakefield is a man who says what he wants to say, not what others may wish to hear. His agenda is to vindicate himself. “The GMC might find fault,” he believed before the findings were handed down. “They might find misconduct, but they won’t find serious professional misconduct.”

How seriously the GMC views yesterday findings of fact will be decided in a few months’ time, together with sanctions against the three doctors. They are likely to be struck off the medical register. Although Wakefield no longer works in England, he may find it hard to attract patients to Thoughtful House, although he believes the findings to be “unfounded and unjust” on all but one count – taking blood samples from children at one of his own children’s birthday parties.

It was a strange thing to do, without approval from the Royal Free’s ethics committee, but he wanted a control group to contrast with his sick patients. He continues to believe it was not unethical. “I had fully informed parent and child consent. The ethics committee is there to protect NHS patients, and these weren’t NHS patients.”

More seriously, he was charged with causing pain to sick children by painful, intrusive diagnostic treatments. But the researchers had ethical approval, he argues, producing a letter, dated 27 Februrary 1997, from Professor Walker-Smith, the head of the department of Paediatric Gastroenterology at the Royal Free, noting approval for biopsies and organising further approvals. Wakefield believes the letter is his smoking gun. “For some bizarre reason the GMC do not seem to have had this document. My barristers didn’t have a copy because their job is to respond to the documents presented to them.”

Other charges related to whether the research team was receiving money for the study as part of a legal action which sought to show a link with MMR. Although some of the children in the study subsequently become part of the legal action, he says they were not involved when he first examined their symptoms, and wrote the report. He saw no conflict. “The Lancet rules then were: ’What do you, the author, think determines conflict of interest?’ A year or two later the definition was changed to 'what others might perceive as conflict of interest’".

Behind his cool manner, and soft voice, lies rage. He believes he has been the victim of a media campaign. “Repeat after me: 'Wakefield discredited, Wakefield discredited,’ if you say it often enough it will stick.” But why? “There was a huge political will to prosecute. Don’t you dare challenge vaccination, was the message. The motive was not always financial. It was a belief system. I am, of course, deeply concerned with public health, but not with the structure of Public Health. I’m interested in the individual who comes in and sits down at the table and says: 'This is what happened to me or my child.’ That’s why I came into medicine.”

Between 1996 and 2000 more than 1,000 pateints were referred to the paediatric gastroenterology team at the Royal Free because Walker-Smith, now retired, was the leading light in the field. “Many of the letters from parents and doctors said the same story, that shortly after vaccination these children had suffered some kind of event that left them with autism and bowel problems. It seemed to be a new kind of autism.” As well as studying patients referred to him from all over the world, he trawled the literature on the safety of vaccines and wrote a 250-page report in which he expressed his horror at the inadequate research.

He regrets the downturn in vaccination that resulted form his work, because lack of compliance “creates a dangerous situation” but feels the Government is responsible. “We added this line to The Lancet paper: 'We do not prove an association between the MMR vaccine and the syndrome described.’ Any drug, especially one that involves three live viruses, must be considered dangerous until proven otherwise. At the press conference I said that I supported the use of single vaccines until any causal link with MMR had been investigated. But the single vaccines weren’t made available.”

Since then many studies have found no link. He remains unconvinced. “There are studies from six countries which show a link. In the US, there have been a number of court cases in which the link has been acknowledged.”

As for the epidemiological studies, he says that you can achieve any result you want by manipulating statistics. “We are not up against science, but interpretation.”

His hope now is that he can continue researching and treating children whose autism seems be at least partially alleviated through managing their gut problems, whatever the cause. “Thousands of children are presented with these problems every day. We can do a huge amount to help them. The more we can understand this disorder, the more impact we can make by practising straightforward simple medicine – and not treating these children as an anomaly or an inevitability. I’m a scientist. I ask questions, I don’t know the answers. The science will tell the story in the end.”
If so, one day, he may be vindicated. But for now he is no hero, only a maverick who put lives at risk because he did not conduct his research properly.

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Found some more on this

To make sure there is no ambiguity, this is from Brian Deer,an investigative journalist whose personal crusade has been to discredit Andrew Wakefeild and his research findings. He is openly biased against the Study and Wakefeild and is unlikely to offer information that supports the other side of this issue.

Andrew Wakefield research exposed: the MMR investigation

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But the investigation discovered that, while Wakefield held himself out to be a dispassionate scientist, two years before the Lancet paper was published - and before any of the 12 children were even referred to the hospital - he had been hired by a lawyer, Richard Barr: a jobbing solicitor in the small eastern English town of King's Lynn, who hoped to raise a speculative class action lawsuit against drug companies which manufactured MMR.

Unlike expert witnesses, who give professional advice and opinions, Wakefield had negotiated a lucrative contract with Barr, then 48, to conduct clinical and scientific research. The goal was to find evidence of what the two men called "a new syndrome", intended to be the centrepiece of (later failed) litigation on behalf of an eventual 1,600 families, mostly recruited through media stories. This, publicly undisclosed, role for Wakefield created the grossest conflict of interest, and the exposure of it by Deer, in February 2004, led to public uproar in Britain, the retraction of the Lancet report's conclusions, and, from July 2007, the longest-ever professional misconduct hearing by the UK's General Medical Council.

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In the Lancet, the 12 children (11 boys and one girl) were held out to be merely a routine series of kids with developmental disorders and digestive symptoms, needing care from the London hospital. That so many of their parents blamed problems on one common vaccine struck an understandable chord of concern. But Deer discovered that the children (aged between 2½ and 9½) had been recruited through MMR campaign groups, and that, at the time of their admission, most of their parents were clients and contacts of the lawyer, Barr. None of the 12 lived in London. Two were brothers. Two attended the same doctor's office, 280 miles from the Royal Free. Three were patients at another hospital clinic. One was flown in from the United States.

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Penetrating veils of medical confidentiality, he discovered that the hospital's clinicians and pathology service had found nothing to implicate MMR, but that Wakefield had repeatedly changed and misreported diagnoses, histories and descriptions of the children, which made it appear that the syndrome had been discovered.

As revealed in The Sunday Times in February 2009, the effect was to give the impression of a link between MMR, bowel disease and the sudden onset of regressive autism, when otherwise none was evident. The hospital's pathology service had repeatedly declared bowel biopsies from the children to be normal, and not one of the 12 cases was free of critical mismatches between the paper which launched the vaccine crisis and the kids' contemporaneous clinical records. Some children showed signs of autism before vaccination. Some were deemed normal months afterwards. Some did not have autism at all.

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Andrew Wakefield found 'irresponsible' by GMC over MMR vaccine scare
Doctor's research triggered a furore and was direct cause of slump in take-up of MMR, which has led to outbreaks of measles in some parts of the country

• Sarah Boseley, health editor
• guardian.co.uk, Thursday 28 January 2010 20.34 GMT

Andrew Wakefield, the doctor who claimed to have discovered a link between measles virus, bowel diseases and autism and thereby sparked widespread fear of the combined MMR jab, conducted unnecessary, invasive tests on children, the General Medical Council found today.
Branding him a dishonest, irresponsible doctor, the GMC disciplinary panel, which has sat and heard evidence for 148 days over two and a half years, finally found a long array of charges against him proven. But there were shouts of protest and dismay from the doctor's supporters.
Wakefield and two other doctors at the Royal Free hospital in London were brought before the GMC over the paper they published in February 1998 in the Lancet medical journal.
On the basis of case studies of just eight children, it suggested that measles virus might be linked to inflammatory bowel disease, which in turn might play a role in autistic spectrum disorder.
The paper conceded that the doctors had not found a definite link, but Wakefield, in a press conference, told the world he believed the measles, mumps and rubella vaccines in the MMR jab should not be given in one combined shot, but in single doses, preferably a year apart. It triggered a furore and was the direct cause of the major slump in take-up of MMR which has led to outbreaks of measles in some parts of the country.
The GMC found that Wakefield had flouted the rules in pursuit of his theory – and profit. At the centre of the case against him is the ethical conduct of the trial which resulted in the Lancet paper. The panel found he had subjected 11 children to invasive tests such as lumbar punctures and colonoscopies that they did not need, without ethical approval.
But investigations revealed more. In June 1997, before the paper was published, he filed a patent as one of the inventors of a vaccine for the elimination of measles virus and for the treatment of inflammatory bowel disease.
In February 1998, the same month as the Lancet paper, he applied for ethical permission to run a trial of a new potential measles vaccine and set up a company called Immunospecifics Biotechnologies Ltd which would produce and sell it. The father of one of the children he had seen with developmental problems and bowel disease would be the managing director. Wakefield tried out the new vaccine on the child, without mentioning it in the medical notes or telling the child's GP. He was also found to have unethically arranged for his son's friends to have blood samples taken from them during his birthday party – for which he paid them £5 each.
Wakefield hit on his theory after seeing children with bowel disease who also had developmental problems. The crucial third step in the hypothesis was the timing of the MMR vaccine: the first shot is given at around 18 months, which is also when autistic spectrum disorders start to be noticed.
In front of the GMC with him were two doctors who were at the time colleagues in the department of paediatric gastroenterology at the Royal Free, Prof John Walker-Smith and Dr (now Prof) Simon Murch. The GMC decided they shared responsibility for the ethical conduct of the trial, although neither one was said to have acted dishonestly.
The trial that Wakefield proposed troubled the ethics committee of the Royal Free. It is a fundamental principle in paediatrics that no child should be subjected to more than a blood test unless it is necessary for their treatment. But Wakefield proposed a barrage of invasive procedures. Dr Evan Harris, the Liberal Democrat spokesman who complained to the GMC, believes the committee should have sought advice from an independent paediatrician. Instead, it asked a gastroenterologist colleague of Wakefield.
The committee gave its conditional approval. The GMC panel decided that those conditions had been flouted – and that the trial had been unethical.
The GMC looked into the cases of eleven children who were entered into the trial. Many rules had been broken. Wakefield's contract was for "experimental gastroenterology" and he was not allowed to treat children, but he ordered tests and procedures that were not necessary for their health. In the interests of proving Wakefield's theory, children were given lumbar punctures in the spine, colonoscopies and barium meals – all significant procedures. Children were enrolled who did not fit the strict criteria for entry to the trial and they had not come from a GP who was referring them because they needed treatment.
Wakefield, now based in the US, has also been found not to have been open with the Lancet. He did not tell them that £55,000 funding for the study came from the legal aid board. Wakefield was advising Richard Barr, a solicitor who wanted evidence to sue the vaccine manufacturers on behalf of the parents of children with autism. It was a clear conflict of interest and should have been declared.
All three doctors will now come back before the panel in April, where the GMC will decide if they are guilty of serious professional misconduct, which could end in one or more of them being stripped of their licence to practise medicine.
Harris said Wakefield's reputation and that of his campaign was "in tatters and it is sad that it has taken so long for this to be demonstrated.
"That the GMC has found Wakefield guilty of unapproved and unnecessary invasive tests, including spinal taps, on young children, is the most damning indictment possible. The findings of failure to declare financial interest are a secondary consideration."
Dr Shona Hilton, of the Medical Research Council, said the scare had a huge impact on parents, undermining their trust in MMR vaccination. "Thankfully confidence is returning and the uptake of MMR vaccine is increasing," she said. "We need to continue rebuilding trust with parents that MMR vaccination is safe and ensure that those parents caring for children with autism do not blame themselves."
Wakefield, who was not at the hearing but spoke outside the GMC offices minutes after the ruling, said he was "extremely disappointed" by the outcome. He said: "The allegations against me and against my colleagues are both unfounded and unjust … and I invite anyone to examine the contents of these proceedings and come to their own conclusion."
He went on: "It remains for me to thank the parents whose commitment and loyalty has been extraordinary.
Thousands of people, mainly parents of autistic children, have continued to support Wakefield. Panel chairman Dr Surendra Kumar was heckled by parents as he delivered the verdicts in central London this afternoon. One woman shouted: "These doctors have not failed our children. You are outrageous."

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<H1>Lancet retracts 'utterly false' MMR paper

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After medical council ruling last week that MMR doctor Andrew Wakefield was dishonest, journal finally quashes paper

• Sarah Boseley, health editor
• guardian.co.uk, Tuesday 2 February 2010 16.29 GMT

Andrew Wakefield 'deceived the journal' says Lancet's editor. Photograph: Steve Parsons/PA Wire/PA

The Lancet today finally retracted the paper that sparked a crisis in MMR vaccination across the UK, following the General Medical Council's decision that its lead author, Andrew Wakefield, had been dishonest.
The medical journal's editor, Richard Horton, told the Guardian today that he realised as soon as he read the GMC findings that the paper, published in February 1998, had to be retracted. "It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false," he said. "I feel I was deceived."
Many in the scientific and medical community have been pressing for the paper, linking the MMR (measles, mumps and rubella) jab to bowel disease and autism, to be quashed. But Horton said he did not have the evidence to do so before the end of the GMC investigation last Thursday.
In 2004, when concerns were first raised about the conduct of the study, the Lancet asked the Royal Free hospital, where Wakefield and his fellow authors worked, to investigate. But Professor Humphrey Hodgson, then vice-dean of the Royal Free and University College school of medicine, wrote to the journal to say it had found no problems. "We are entirely satisfied that the investigations performed on children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny," he said at that time.
The GMC last week disagreed. Children had been subjected to invasive procedures that were not warranted, a disciplinary panel ruled. They had undergone lumbar punctures and other tests solely for research purposes and without valid ethical approval.
Wakefield "was dishonest", said Horton. "He deceived the journal." The Lancet had done what it could to establish that the research was valid, by having it peer-reviewed. But there is a limit, he said, to what peer-review can ascertain.
"Peer review is the best system we have got for checking accuracy and acceptability of work, but unless we went into the lab or examined every case record, we can't ever finally rule out some element of misconduct. The entire system depends upon trust. Most of the time we think it works well, but there will be a few instances – and when they happen they are huge instances – where the whole thing falls apart."
When journals have suspicions of fraud or misconduct, they have to refer them to the institution employing the scientists. "We rely on the processes within institutions to investigate allegations of fraud, and if they are found to be wanting, that is extremely disappointing," he said.
Dr Michael Fitzpatrick, author of books on the MMR scare, said the retraction was "good news – only 10 years too late".

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one little thing in this whole thing sparks a serious bad chord with me (apart from the part where he contributed to a historical rise in Measles in the UK).

The guy performed un-neccesary colonoscopies on children.

These hurt, quite a bit, and I could not imagine how they would be added on top of a bowel disease.

Seriously, if it was my kid in the study, I would have punched this guy in the throat...

(yes, i do think the worlds problems can be solved with violence, you should have seen how I built a garden edge using only my jab.)

This all makes me so mad. So mad for those poor children. So mad at this quack of a "doctor" who published such a flawed study. So mad that I fell for it. The years of chinese whispers about MMR and autism that this study sparked were in my head and made me feel very unsure about giving our son this vaccine when really, I can't find a single piece of good science to indicate a causation. Craziness.

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This all makes me so mad. So mad for those poor children. So mad at this quack of a "doctor" who published such a flawed study. So mad that I fell for it. The years of chinese whispers about MMR and autism that this study sparked were in my head and made me feel very unsure about giving our son this vaccine when really, I can't find a single piece of good science to indicate a causation. Craziness.

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you have to keep in mind that its not the conclusions of the study that has been on trial....its the doctors conduct that they are putting on trial.

in my opionion, if they can discredit him personally, they can indirectly discredit his findings. I can see from your comment that they have achieved this with yourself and a few others here...imagine how many people have read these same articles and decided that MMR must be safe to use because "this Dr is unethical and therefore who can trust anything he says"

I'm not buying it. Ok the doctor may have overstepped some boundaries, but perhaps in an industry so controlled by big business ie billion dollar pharmaceutical companies who get paid a lot of money to make vaccines, the only way to conduct such research is to bend the rules a little.

its not like the manufacturers are going to open the doors and let you in.

Unnecessary procedures go on all the time in studies and even unstudied medicine but no-one seems to care so much about that, I wonder why? My mum was friends with a woman who volunteered her daughter for a study which involved her fasting for quite a lengthy time... mum was horrified at the time, I was too young to understand much... what about the use of unstudied stuff in obstetric medicine like Thalidomide? One of the biggest medical tragedies of all time Devastating.

Thalidomide - Wikipedia, the free encyclopedia

Why does this guy have MASSES of followers and believers who saw their children disintegrate after their vaccines? What does it take to get this out when everyone is trying to shut alternate views to the money making views? Why can't he be given a fair research opportunity now to prove his points?

Once I read his study I was in utter disbelief that his findings had become so wide spread. The flaws are visable a mile off- such a small sample size, a retrospective study that linked MMR and autism based on parental say-so rather than studied fact etc etc. I couldn't beleive that I had been concerned about a possible link between MMR and autisim when THIS was the study to base that on. There have been other much better researched studies that have not found a link and given how poorly this study was executed I'm appalled it's effect has been so far reaching. Then his misconduct and the treatment the children received in his study came out. I think I went beyond appalled but sickened then.

Yeah, the big thing is that almost nobody read the report. It was basically a big old chineese whispers of fear.

Japan even split the vaccines completely without any effect to the numbers of children with autism.

Peg, The conclusions of this study are a big big part of what was on trial. When your method is flawed then so is your conclusion.

Almost all the doctors involved retracted their support upon reading the findings as they did not agree.

To understand how this study was performed.... Dr Whatshisname develops a hypothesis.... "All Grey things are Elephants" and then to test his theory he went and found 12 grey elephants and then studied them to support the hypothesis.

We as rational people understand that Elephants are grey but all grey things are not Elephants but the study says otherwise....

Have a read of the linked stuff. This "doctor" had a tiny sample that was hand picked/recruited he also had shares in a new MMR vaccine in development. He was also being paid by a litigation lawyer to investigate this same hypothetical link so that he could sue the drug companies...

The more you read about this guy the more it stinks... like child abuse and fearmongering

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Unnecessary procedures go on all the time in studies and even unstudied medicine but no-one seems to care so much about that, I wonder why? My mum was friends with a woman who volunteered her daughter for a study which involved her fasting for quite a lengthy time... mum was horrified at the time, I was too young to understand much... what about the use of unstudied stuff in obstetric medicine like Thalidomide? One of the biggest medical tragedies of all time Devastating.

Thalidomide - Wikipedia, the free encyclopedia

Why does this guy have MASSES of followers and believers who saw their children disintegrate after their vaccines? What does it take to get this out when everyone is trying to shut alternate views to the money making views? Why can't he be given a fair research opportunity now to prove his points?

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Why? Because fear is a powerful weapon. Especially when our children or loved ones are concerned. Just as scaring people into vaccination can be powerful marketing and or social service, so too anti vaccine beliefs can use the same tactics. Create enough doubt with 'viral' internet techniques and 'loud' posting website and blogging techniques, any opinion can become "believable". No different to a cult.

Clearly those that rely on the net to publish their opinions need to look at the way they operate if the alternatives aren't listening. If that means better, legitamate research, then that is what has to be done.

Unofrtunately this blocke went about things the wrong way. In medicine that make you mud.

Adrian had his jabs the other day and I can honestly say that despite knowing all this stuff I still had the tiniest speck of "what if" and I remembered this thread

I found some more really good stuff to read for anyone whe is still diong the research

This is a document referencing all MMR-Autism studies (25 say no link and 3 say there is but one of them is the now retracted Lancet and another is in dispute due to inability to replicate findings)
http://www.immunize.org/catg.d/p4026.pdf

This is a very good decision helping tool that discusses the facts about Measels, Mumps and Rubella and the Vaccine.
MMR Decision Aid - NCIRS - National Centre for Immunisation Research and Surveillance