By Dan Olmsted
What, exactly, did Dr. Andrew Wakefield do wrong?
To most people who followed the drumbeat of news about the retraction of his 1998 Lancet paper – and especially to most of the mainstream media who did the “reporting” – that does not need to be put in the form of a question. Wakefield’s medical license is now in jeopardy because he did just about EVERYTHING wrong in an “Early Report", (HERE) a case series on 12 children with regressive autism and a novel bowel disorder their parents or doctor attributed, in most cases, to administration of the MMR vaccine. Given the egregiousness of these wrongs and the prestige-ousness of those who announced them, the “question” moved almost immediately from who, what, when and where to why – why had the Lancet let itself be so misused as to publish the claim that vaccines cause autism based on a bogus study; why had it taken so long to disavow such fraudulent nonsense?
And now we’ve sunk to the seventh circle of journalism hell – based on this slapdash and slipshod reporting, the media says the entire debate over vaccines and autism has been settled. Nothing to see here. Please move along.
Not so fast. The media’s first job is to report the facts correctly, and a corollary to that is to “rely on your own original reporting” whenever possible, according to “The Elements of Journalism” by the respected journalism elders Bill Kovach and Tom Rosenthal. At a minimum in the Wakefield case, this would mean that key reporters breaking the story nationally – on the TV news networks and major online news sites, in the big dailies and magazines – needed to be familiar with three things: Wakefield’s original paper; the General Medical Council ruling from the week before that found his ethical behavior “dishonest,” and The Lancet retraction of the paper itself that quickly followed.
“Being familiar with” in this circumstance, it seems to me, means reading the paper (with comprehension, as they used to say in grade school) and retaining its key elements. This story had been coming down the pike for months, so there was no reason to be unprepared. Even if, given the 24/7 Internet exigencies of today’s news cycle, a reporter was caught flat-footed, the same Internet provides instant access to primary materials. What’s more, the Wakefield report is only five pages long and the relevant passages are in unusually plain English for a scientific report. (Anyone who thinks this level of diligence is asking too much of reporters and editors doesn’t really understand the value or purpose of journalism, or why the Amendment by which it is protected is the First.) It wouldn’t have hurt to talk to Wakefield or the parents of the children involved in the study, either, but that appears to be asking way too much.
So setting a very low bar -- mere factual accuracy -- how did the media do? They got just about EVERYTHING wrong, and persisted in error even when it was being pointed out to them. The media were not helped by The Lancet’s own strangely worded (and, ultimately, inaccurate) retraction and failure to fully explain itself, but that’s not a good enough excuse.
As a way to focus the issue, it is fair to say that Wakefield’s presumed offenses can be broken out into two categories: acts of commission or omission that were morally wrong – unethical – on the one hand, and those that were scientifically wrong on the other. Because of the demonstrably inaccurate reporting of the science – the heart, after all, of a scientific work, we will discuss that here. (THIS report by Dr. Bill Long in The Autism File magazine does a good job of laying out the ethics charges and demonstrating what we strongly believe is their lack of merit.)
In this case it makes narrative sense to start in medeas res, in the middle of things, with the Lancet’s retraction. It is short, and here it is in full:
“Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”
One could watch news outlets grappling with this statement in real time. At Forbes.com, Senior Editor Michael Herper lampooned the Lancet’s language as “incomprehensible” and offered his own rewrite of what it was trying to say: “In particular, the patients were not ‘consecutively referred,’ raising the odds that the results were due to chance.”
HERE is CNN on the same day:
(CNN) -- The medical journal The Lancet on Tuesday retracted a controversial 1998 paper that linked the measles, mumps and rubella (MMR) vaccine to autism. The study subsequently had been discredited, and last week, the lead author, Dr. Andrew Wakefield, was found to have acted unethically in conducting the research. The General Medical Council, which oversees doctors in Britain, said that ‘there was a biased selection of patients in The Lancet paper’ and that his ‘conduct in this regard was dishonest and irresponsible.’”
That was online. On air, this is what senior medical correspondent Elizabeth Cohen told its worldwide audience: “What happened was there was this study by a guy named Andrew Wakefield back in 1998 and that sort of started off this whole movement of saying there was a link between autism and childhood vaccines, because that was what the study said. And people pointed to this study over and over again to show that there was a link. …
“The bottom line of why they need to retract it is because – they didn’t fully explain it and they wouldn’t answer our questions – but the editors basically said that the study wasn’t done in a fully randomized way. When you do a study, you’re supposed to randomly choose your study subjects and study them, and see what the cause and effect is of what you’re looking at. But basically they said that this wasn’t, the subjects of the Wakefield study were not randomly chosen. If you don’t choose your study subjects randomly, you don’t have a valid study.”
But this was NOT a randomized clinical trial; rather, it was a report on a series of children picked for what they had IN COMMON, which was developmental regression and a bowel disorder. Here’s how the National Cancer Institute identifies a consecutive case series: “A clinical study that includes all eligible patients identified by the researchers during the study registration period. The patients are treated in the order in which they are identified. This type of study usually does not have a control group.”
The day after Dr. Cohen’s incoherent explanation, Age of Autism's Kim Stagliano appeared with her in a segment (Watch HERE). “I’d like to point out to Elizabeth, please, that Dr. Wakefield did not produce a study. It was a case series with a dozen children.” What did it really say? Kim actually quoted it – a rarity in any of the coverage. “We have not shown an association between the syndrome” – meaning autism – and MMR.”
Responded Cohen: “I think people would differ with what she has to say. I think this study gave a strong suggestion that there was a link between childhood vaccines and autism.”
CNN quoted Dr. Marcia Angell, a former editor of The New England Journal of Medicine. "It sounds like there was a misleading design of the study ... patients not randomly chosen.”
Yes, it sounds like that from the reports like CNN’s – even to someone like Marcia Angell, a fierce critic of drug company influence in the medical journal business and author such works as, “How the Drug Industry Distorts Medicine and Politics: America’s Other Medical Problems.”
The Lancet’s retraction and the media’s reporting thus convinced everyone that, entirely aside from the alleged ethical wrongs, the science underlying the report was fatally flawed. If only the report had been a book, we could burn it.
But before consigning it to the flames, let’s pause for a moment on the original report itself. (“In times of tumult and discord,” wrote Publius Corneilius Tacitus, “bad men have the most power; mental and moral excellence require peace and quietness.”) Let’s quit foaming at the mouth and take the time to ask, what did it claim to be doing, and what did it actually do? We are going to let it speak for itself in these few short excerpts:
“We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder. … We saw several children who, after a period of apparent normality, lost acquired skills, including communication. They all had gastrointestinal symptoms, including abdominal pain, diarrhoea, and bloating and, in some cases, food intolerance. We describe the clinical findings, and gastrointestinal features of these children….
“12 children, consecutively referred to the department of paediatric gastroenterology with a history of a pervasive developmental disorder with loss of acquired skills and intestinal symptoms (diarrhoea, abdominal pain, bloating and food intolerance), were investigated. All children were admitted to the ward for 1 week, accompanied by their parents. …
“We describe a pattern of colitis and ileal-lymphoid-nodular hyperplasia in children with developmental disorders. Intestinal and behavioural pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group; however, the uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunction in children with autistic-spectrum disorders, suggests that the connection is real and reflects a unique disease process.”
Thus Wakefield et al. were explicit about methodology: The paper was about a series of patients with autism spectrum disorders whose parents brought them to the clinic’s pediatric gut disease practice. It is consecutive because all of the first 12 children referred in that way comprised the series. Given this, there was a chance the pattern was random. But given the novelty and seriousness of the GI disturbance, it probably was not.
How did the MMR feature in this? NOT in the way it has been reported. “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. … In eight children [the total later rose to nine], the onset of behavioural problems had been linked, either by the parents or by the child’s physician, with measles, mumps, and rubella vaccination. Five had had an early adverse reaction to immunisation (rash, fever, delirium; and, in three cases, convulsions). In these eight children the average interval from exposure to first behavioural symptoms was 6.3 days (range 1–14). Parents were less clear about the timing of onset of abdominal symptoms because children were not toilet trained at the time or because behavioural features made children unable to communicate symptoms. … Further investigations are needed to examine this syndrome and its possible relation to this vaccine.” When asked at a subsequent press conference (arranged by the hospital, not Wakefield), he responded that getting separate shots would be prudent until stronger evidence emerged one way or the other. And good for him.
Much has been made of the fact that some of the children later became parties to planned litigation against the MMR manufacturer. Conflating these two separate tracks to make Wakefield look like a villain has worked remarkably well in distracting journalists who, as we’re seeing, can’t get even the basic story straight. The simple fact, Wakefield told me, is that none of the children referred to his clinic were involved in litigation when the referrals were made, and only one MAY have held a Legal Aid Board certificate at the time of examination. What really happened to set the Lancet study in motion was that a woman named Rose Kessick called Wakefield’s office – he answered the phone himself – in 1995 to tell him she thought her son, William, had developed autism and a bowel disorder as a result of his MMR shot. Wakefield referred her to his colleague, John Walker-Smith, thus making William the "sentinel child" in the consecutive case series. Rose was in touch with a few other parents who believed the same thing, and through a perfectly ordinary process of self-referral, the 12 cases made their way to Wakefield et al.
In a phone conversation with me and Mark Blaxill, Rose Kessick expressed continued amazement at the media’s inability to grasp the simple fact that a new cluster of children with regressive autism stood out at a clinic devoted to treating pediatric gut disease. “Clearly, if anybody’s doing a case series, they have to understand that the original clinic was not a clinic for autistic children,” she told us. “This was a clinic where all sorts of children would come in with the common factor of bowel disease.”
We read her the “12 children consecutively referred” sentence from the paper. “What argument are they using to say the children are not consecutively referred?” she said. As Wakefield reiterated to me, the case series comprised “the first 12 children referred to Walker-Smith with these symptoms of regression and abdominal problems. That is so unambiguous and straightforward, what could possibly be the problem? Of course they were consecutively referred.”
Now the editorialists are weighing in after reading their own newspapers’ garbled accounts, creating an echo chamber of bad journalism and mistaken judgment. “For a decade, many parents have worried that vaccines might somehow be causing autism in children,” wrote The New York Times, unofficial scribe of the American Academy of Pediatrics. “Repeated assurances from respected experts that there is no link have failed to quiet those fears. Now The Lancet, a prestigious British medical journal that published the paper that first gave wide credence to those fears, has retracted it, saying that the paper’s authors had made false claims about how the study was conducted.” That’s a clear reference to the “consecutive series” statement.
The Times’ rowdy neighbor, The New York Daily News, in an editorial titled “Hippocrates would puke: Doctor hoaxed parents into denying kids vaccine,” opined: “Now, though, the United Kingdom's General Medical Council, which licenses doctors, has concluded that Wakefield cherry-picked the children who became his study subjects, including paying kids at his son's birthday party to give blood.” (Wrong again: That incident was unrelated to the Lancet study, and far too much has been made of it when weighed against infants getting half a dozen and more shots on one “well-baby visit” and developing regressive autism and a novel bowel disorder. But that’s another story – this one!)
So, again, what exactly did Wakefield do wrong? We fail to see a problem here. The paper as published meets every test of transparency we can imagine – including the comment that the self-referrals by the parents raised the risk of a chance pattern. To reel in horror 12 years later over a non-randomized, cherry-picked, biased report that might have been due to chance – well, it makes you want to puke.
The fact remains that Wakefield’s paper, tentative and preliminary though it was, has been amply borne out by subsequent research and the experience of thousands of parents. It is among the handful of landmark papers, studies or books in the history of autism research – and, fittingly, an echo of the original report on the disorder written in 1943 by Johns Hopkins child psychiatrist Leo Kanner, “Autistic Disturbances of Affective Contact.” Kanner wrote about 11 children – one fewer than Wakefield – who were seen at his psychiatric clinic between 1938 and 1943. They were consecutively referred – Kanner wrote about every single child who fit his definition of the novel behavioral syndrome. Did he “cherry pick” them from among the thousands who no doubt arrived at his world-famous clinic during eight years? Of course not; he isolated them based on their striking behavior. Here is how he begins:
“Since 1938, there have come to our attention a number of children whose condition differs so markedly and uniquely from anything reported so far, that each case merits - and, I hope, will eventually receive - a detailed consideration of its fascinating peculiarities.”
Let’s rewrite Wakefield et al. into that language: “Since 1995 there have come to our attention a number of children with regressive autism spectrum disorders and a novel bowel syndrome, a combination that differs so markedly and uniquely from anything reported so far that each case merits a detailed consideration of its fascinating peculiarities. Follow-up studies looking into a possible environmental trigger – in most of these cases, parents or doctors reported onset of the ASD in association with MMR vaccination – will eventually establish whether there is any correlation.”
To casual observers – and, sadly, that means the media as well -- the Wakefield case is a vivid tapestry of lies, outrageous moral behavior and bad science. But up close, under the microscope the media should be using, this damning picture is made up of many frayed and badly dyed threads woven together. We’ve pulled on just one of those threads in this article, because of its centrality to the paper’s validity and its implication for the broader issue of whether the mainstream media can be trusted to unravel the most important story of our time -- the fate of the next generation. Obviously, it can’t, and that is scary as hell.
Dan Olmsted is Editor of Age of Autism.