Vaccine science

Yet the science remains a problem. No researchers have been able to replicate the results produced by Wakefield’s team in the Lancet study. Some used statistics to see if autism took off in 1988, when MMR was introduced. It did not. Others used virology to see if MMR caused bowel disease, a core suggestion in the paper. It did not. Yet more replicated the exact Wakefield tests. They showed nothing like what he said. Wakefield himself, however, stands by his results, insisting that a link between MMR and autism merits inquiry. The 12 other doctors whose names were attached to the Lancet paper, which was written by Wakefield, were not involved in preparing the data used.

“This study created a sensation among the public that was impossible to counter, despite overwhelming evidence to the contrary,” says Professor Gary Freed, director of the child health research unit at the University of Michigan, who has watched the scare take off in America. “Overwhelming biologic and epidemiologic evidence has demonstrated conclusively that there is no association between the MMR vaccine and autism, and yet this thing goes on.”

Aspects of the project are now before the General Medical Council (GMC), the doctors’ disciplinary body. Wakefield and two professors, John Walk-er-Smith, 72, and Simon Murch, 52, are charged with carrying out unauthorised research on the 12 children. The charges, which they strongly deny, relate to the ethics of the treatment of the 12 children, not the results of the research.

In evidence presented to the GMC, however, there has emerged potential explanations of how Wakefield was able to obtain the results he did. This evidence, combined with unprecedented access to medical records, a mass of confidential documents and cooperation from parents during an investigation by this newspaper, has shown the selective reporting and changes to findings that allowed a link between MMR and autism to be asserted.

MR ELEVEN’S taxi dash was a small ride in his desperate quest to find an answer for his son’s condition. Today, Child Eleven is much improved: at 17, he is a terrific scholar, although too nervous to drive.

The extra tests on his biopsies produced striking results. His father asked the cancer institute to look for the measles virus, which lay at the heart of Wakefield’s concerns over the vaccine. According to a theory that underpinned the project, this virus in MMR was the cause of bowel disease, which then did damage to children’s brains.

“It took a big fight to get the information,” said Mr Eleven. “They told me there was no measles virus. I had the tests repeated three times at different labs in the US, and they all came back negative.” This struck a different note from what Wakefield suggested when describing his research to the world. “We would not have presented this paper to The Lancet had we not undertaken extensive virological studies already,” he told the 1998 press conference.

At face value, this is an anomaly. In science, however, these are endless and can sometimes eventually be explained. This is why studies are usually repeated. But at the heart of Wakefield’s findings The Sunday Times found more discrepancies, inconsistencies and changes.

WHEN the children first arrived at the Royal Free, in addition to autism, they were also reported with constipation, diarrhoea or other common bowel complaints. This was the reason given for them travelling between 60 and 5,000 miles to London to enter the care of Wakefield’s team.
Wakefield, now 52, a former gut surgeon, was at the time doing academic research in the Royal Free’s medical school on Crohn’s disease, an ulcerating inflammation. In 1995, he had developed a theory that this condition was caused by the measles virus, which is found live in MMR. The theory has since been discounted.

This work was the bedrock on which he based his new claims. Yet this too appears problematic. The children were supposed to have a new inflammatory bowel disease, written up in the Lancet paper as “consistent gastrointestinal findings” involving “nonspecific colitis”. Wakefield said that this inflammation of the colon caused the gut to become “leaky”, allowing food-derived poisons to pass into the blood-stream and the brain.

“The uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunc-tion in children with autistic-spectrum disorders, suggests that the connection is real and reflects a unique disease process, ” the Lancet Paper explained of the “syndrome”.
Yet pathology records of samples taken from the children show apparent problems with this evidence. The hospital’s consultants who took biopsies from the children’s colons concluded that they were not uniform but varied and unexceptional.

For Child Eight, the pathology report said: “No abnormality detected”, while the Lancet paper said: “Nonspecific colitis”. This pattern was repeated for two of the other children, Nine and Ten.
The most striking change of opinion came in the case of Child Three, a six-year-old from Huyton, Merseyside. He was reported in the journal to be suffering from regressive autism and bowel disease: specifically “acute and chronic nonspecific colitis”. The boy’s hospital discharge summary, however, said there was nothing untoward in his biopsy.

A Royal Free consultant pathologist questioned a draft text of the paper. “I was somewhat concerned with the use of the word ‘colitis’,” Susan Davies, a co-author, told the ongoing GMC inquiry into the ethics of how the children were treated, in September 2007.
“I was concerned that what we had seen in these children was relatively minor.”

However, after her challenge, it was explained, Wakefield’s team met for a “research review” of the biopsies. It was not an unusual move for a group of specialists to reconsider the evidence upon which their research was relying. It was nevertheless striking that their conclusion was that 11 of the children’s bowels were in fact diseased when their colleagues had found no abnormalities in at least seven of the cases.

Further questions arise about the motivations of Wakefield. Five years ago this month, The Sunday Times reported that he worked for lawyers, and that many of the families were either litigants or were part of networks through which they would sue. Far from routine referrals, as they appeared, many of them had made contact with one another.

Child Six and Child Seven were brothers from East Sussex; Child Four, a 9½-year-old from North Shields, Tyneside, was registered with the same GP as Child Eight. In short, the 12, none of whom came from London, fetched up far-from-routinely at the hospital.

The mothers of Child Two and Child Three told me what others said in medical records: they had heard of Wakefield through the MMR vaccine campaign, Jabs. Thus, when they arrived on Malcolm ward, and produced the “finding” about MMR, it was by no means a random sample of cases.
What parents did not know was that, two years before, Wakefield had been hired by Jabs’s lawyer, Richard Barr, a high-street solicitor in King’s Lynn, Norfolk. Barr had obtained legal aid to probe MMR for any evidence that could be used against the manufacturers. He is adamant that at all times he acted professionally, and diligently represented his clients.

A string of Sunday Times reports have exposed how Wakefield earned £435,643 through his work with Barr, plus funding to support his research. There is no suggestion the other doctors knew of Wakefield’s involvement with Barr. What has not been reported is that the nature of the project had been visualised before any of the children were even admitted to the Royal Free.

In June 1996 – the month before Child One’s arrival at the hospital – Wakefield and Barr filed a confidential document with the government’s Legal Aid Board, appearing already to know of a “new syndrome”. Referring to inflammatory bowel disease, and then bowel problems with autism, Wakefield and Barr wrote to the board, successfully seeking money.

“The objective,” they wrote, “is to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported with considerable frequency by families who are seeking compensation.”

Twenty months later, the Royal Free team delivered with the paper that had found a “new syndrome”. TODAY, the 12 children are mostly teenagers. At least three are bloggers, two in support of Wakefield, while others have limited skills. The wrongful stigma of disability hangs heavy on most, and heaviest on the families with the misguided burden of guilt that the vaccine scare has visited on them.

Wakefield has left Britain to live in Austin, Texas, where he runs a clinic offering colono-scopies to American children. He tours the country, giving lectures and speeches against the vaccine, and attracting a loyal following of young mothers. In Wakefield’s view, the Lancet paper was accurate, including reasonable reassessment of findings. Other doctors, including an experienced pathologist concurred with his judgment on the revised reports of nonspecific colitis, he has said.
Behavioural diagnoses, meanwhile, involved a confusing array of technical names, and he trusted what the parents told him. The fact that they said the problems followed MMR implied that regression was involved.

When our allegations were put to him last week, he did not respond, but his lawyers replied on his behalf. They said the GMC hearings were nearing conclusion and our revelations risked prejudicing these proceedings. “You also know that, at this juncture in the GMC process, it would be inappropriate for Dr Wakefield to give a detailed response to you,” they said. “He has denied the allegations and gave a detailed response over many days to the GMC panel.”

Many of the parents of the original 12 children continue to support him and campaign vigorously on his behalf. But others whose children took part in the Lancet project are too burdened and traumatised for campaigning. One mother told me that, before her son’s MMR jab, he could say “night, night mummy”, but all language slipped away “some time” after the injection. To this day, she remains convinced it was the vaccine that did it. She believes it was the rubella component.

When asked why his parents took him to the Royal Free, his father answered: “We were just vulnerable. We were looking for answers.”