"An elaborate fraud"

In completely unsurprising news, discredited and disgraced former doctor Andrew Wakefield has been found, apparently more conclusively, to be a liar. For those who do not know who Wakefield is, he is the man who set off the vaccine scare by linking the MMR vaccine to causing autism. Back in May of last year, he was stripped of his medical credentials. To recall:

In making the verdict on the sanctions, Dr Surendra Kumar, the panel's chairman, said Dr Wakefield had "brought the medical profession into disrepute" and his behaviour constituted "multiple separate instances of serious professional misconduct".

In total, he was found guilty of more than 30 charges.

That was the result after the General Medical Council found that he had acted "dishonestly and irresponsibly" in his research and "with callous disregard" for the children he conducted research on.

Now, an investigative (not clinical) piece published in the British Medical Journal has elaborated on the Council's point by further exposing Wakefield:

An investigation published by the British medical journal BMJ concludes the study's author, Dr. Andrew Wakefield, misrepresented or altered the medical histories of all 12 of the patients whose cases formed the basis of the 1998 study -- and that there was "no doubt" Wakefield was responsible.

"It's one thing to have a bad study, a study full of error, and for the authors then to admit that they made errors," Fiona Godlee, BMJ's editor-in-chief, told CNN. "But in this case, we have a very different picture of what seems to be a deliberate attempt to create an impression that there was a link by falsifying the data."

[...]

"But perhaps as important as the scare's effect on infectious disease is the energy, emotion and money that have been diverted away from efforts to understand the real causes of autism and how to help children and families who live with it," the BMJ editorial states.

Wakefield has been unable to reproduce his results in the face of criticism, and other researchers have been unable to match them. Most of his co-authors withdrew their names from the study in 2004 after learning he had had been paid by a law firm that intended to sue vaccine manufacturers -- a serious conflict of interest he failed to disclose. After years on controversy, the Lancet, the prestigious journal that originally published the research, retracted Wakefield's paper last February.

The series of articles launched Wednesday are investigative journalism, not results of a clinical study. The writer, Brian Deer, said Wakefield "chiseled" the data before him, "falsifying medical histories of children and essentially concocting a picture, which was the picture he was contracted to find by lawyers hoping to sue vaccine manufacturers and to create a vaccine scare."

According to BMJ, Wakefield received more than 435,000 pounds ($674,000) from the lawyers. Godlee said the study shows that of the 12 cases Wakefield examined in his paper, five showed developmental problems before receiving the MMR vaccine and three never had autism.

"It's always hard to explain fraud and where it affects people to lie in science," Godlee said. "But it does seem a financial motive was underlying this, both in terms of payments by lawyers and through legal aid grants that he received but also through financial schemes that he hoped would benefit him through diagnostic and other tests for autism and MMR-related issues."

In 2005, Wakefield founded an autism clinic in Texas (where he earned a $270K/year salary). He resigned after the Medical Council found him guilty (but before they stripped him of his credentials). As per usual, Wakefield is insisting he's innocent and that all of this is a witch hunt designed to quell anyone who questions vaccine safety.

A witch hunt, eh? Once again, let's review.

In 1998 a British doctor named Andrew Wakefield published an article in the respected medical journal The Lancet. He did intestinal biopsies via colonoscopy on 12 children with intestinal symptoms and developmental disorders, 10 of whom were autistic, and found a pattern of intestinal inflammation. The parents of 8 of the autistic children thought they had developed their autistic symptoms right after they got the MMR vaccine. The published paper stated clearly: “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue.”

Despite this disclaimer, Wakefield immediately held a press conference to say the MMR vaccine probably caused autism and to recommend stopping MMR injections. Instead, he recommended giving the 3 individual components separately at intervals of a year or more.[...]

Wakefield’s data was later discredited (more about that later) but even if it had been right, it wouldn’t have been good science. To show that intestinal inflammation is linked to autism, you would have to compare the rate in autistic children to the rate in non-autistic children. Wakefield used no controls. To implicate the MMR vaccine, you would have to show that the rate of autism was greater in children who got the vaccine and verify that autism developed after the shot. Wakefield made no attempt to do that.

His thinking was fanciful and full of assumptions. He hypothesized that measles virus damaged the intestinal wall, that the bowel then leaked some unidentified protein, and that said protein went to the brain and somehow caused autism. There was no good rationale for separating and delaying the components, because if measles was the culprit, wouldn’t one expect it to cause the same harm when given individually? As one of his critics pointed out: “Single vaccines, spaced a year apart, clearly expose children to greater risk of infection, as well as additional distress and expense, and no evidence had been produced upon which to adopt such a policy.”

Wakefield had been involved in questionable research before. He published a study in 1993 where he allegedly found measles RNA in intestinal biopsies from patients with Crohn’s disease (an inflammatory bowel disease). He claimed that natural measles infections and measles vaccines were the cause of that disease. Others tried to replicate his findings and couldn’t. No one else could find measles RNA in Crohn’s patients; they determined that Crohn’s patients were no more likely to have had measles than other patients, and people who had had MMR vaccines were no more likely to develop Crohn’s. Wakefield had to admit he was wrong, and in 1998 he published another paper entitled “Measles RNA Is Not Detected in Inflammatory Bowel Disease.” In a related incident, at a national meeting he stated that Crohn’s patients had higher levels of measles antibody in their blood. An audience member said that was not true — he knew because he was the one who had personally done the blood tests Wakefield was referring to. Wakefield was forced to back down.

In 2002, Wakefield published another paper showing that measles RNA had been detected in intestinal biopsies of patients with bowel disease and developmental disorders. The tests were done at Unigenetics lab. Actually, Wakefield’s own lab had looked for measles RNA in the patients in the 1998 study. His research assistant, Nicholas Chadwick, later testified that he had been present in the operating room when intestinal biopsies and spinal fluid samples were obtained and had personally tested all the samples for RNA with a polymerase chain reaction (PCR) test. The results were all negative, and he testified that Wakefield knew the results were negative when he submitted his paper to The Lancet. Chadwick had asked that his name be taken off the paper. So the statement in the paper that “virologic studies were underway” was misleading. Virologic studies had already been done in Wakefield’s own lab and were negative. Wakefield was dissatisfied with those results and went to Unigenetics hoping for a different answer.

Soon Wakefield’s credibility started to dissolve. The Lancet retracted his paper. Richard Horton, editor of The Lancet, described the original paper as “fatally flawed” and apologized for publishing it. [...]

Attempts to replicate Wakefield’s study all failed. Other studies showed that the detection of measles virus was no greater in autistics, that the rate of intestinal disease was no greater in autistics, that there was no correlation between MMR and autism onset, and that there was no correlation between MMR and autism, period.
In 2001 the Royal Free Hospital asked Wakefield to resign. In 2003, Brian Deer began an extensive investigation6 leading to an exposé in the The Sunday Times and on British television. In 2005 the General Medical Council (the British equivalent of state medical licensing boards in the U.S.) charged Wakefield with several counts of professional misconduct.

One disturbing revelation followed another. They discovered that two years before his study was published, Wakefield had been approached by a lawyer representing several families with autistic children. The lawyer specifically hired Wakefield to do research to find justification for a class action suit against MMR manufacturers. The children of the lawyer’s clients were referred to Wakefield for the study, and 11 of his 12 subjects were eventually litigants. Wakefield failed to disclose this conflict of interest. He also failed to disclose how the subjects were recruited for his study.

Wakefield was paid a total of nearly half a million pounds plus expenses by the lawyer. The payments were billed through a company of Wakefield’s wife. He never declared his source of funding until it was revealed by Brian Deer. Originally he had denied being paid at all. Even after he admitted it, he lied about the amount he was paid. Before the study was published, Wakefield had filed patents for his own separate measles vaccine, as well as other autism-related products. He failed to disclose this significant conflict of interest. Human research must be approved by the hospital’s ethics committee. Wakefield’s study was not approved. When confronted, Wakefield first claimed that it was approved, then claimed he didn’t need approval. Wakefield bought blood samples for his research from children (as young as 4) attending his son’s birthday party. He callously joked in public about them crying, fainting and vomiting. He paid the kids £5 each.

The General Medical Council accused him of ordering invasive and potentially harmful studies (colonoscopies and spinal taps) without proper approval and contrary to the children’s clinical interests, when these diagnostic tests were not indicated by the children’s symptoms or medical history. One child suffered multiple bowel perforations during the colonoscopy. Several had problems with the anesthetic. Children were subjected to sedation for other non-indicated tests like MRIs. Brian Deer was able to access the medical records of Wakefield’s subjects. He found that several of them had evidence of autistic symptoms documented in their medical records before they got the MMR vaccine. The intestinal biopsies were originally reported as normal by hospital pathologists. They were reviewed, re-interpreted, and reported as abnormal in Wakefield’s paper.

Witch hunt. Sure. He'll be on Anderson Cooper tonight, vainly attempting to cover his ass.



[While the post is about Andrew Wakefield, it's inevitable that the conversation in comments will also include the topic of vaccinations in-general. Thus, we have some commenting guidelines on this one: We realize there are varying views on vaccines among Shakers, and no opinion is off-limits in the discussion, but we request that people make sure they are using "I" language to express those opinions and not making sweeping generalizations. Let's keep this a civil conversation, please.]