If I am wrong I will be a bad person because I will have raised this spectre.
The martyrdom of brave maverick Saint Andy continues apace, it would appear.
As you recall, last week, after an interminable proceeding that stretched out over two and a half years, the General Medical Council in the U.K. finally ruled on the question of whether Andrew Wakefield, the man whose incompetently performed, trial lawyer-backed study published in the Lancet in 1998, acted unethically. The answer, not surprisingly, was a resounding yes, or, as Mark Slackmeyer would put it, “Guilty! Guilty! Guilty! Guilty!” True, not all the counts against Wakefield were ruled as proven, but most damning of them were, including misuse of public funds, performing invasive procedures on children for research purposes without proper ethics panel approval, and, worst of all from my perspective, acting not in the best interests of the children under the care of his research team. That last one, quite frankly, is unforgivable–every bit as unforgivable as wrong site surgery or mistakenly giving overdoses of radiation. Its manifestation was the performance of medically unnecessary invasive procedures, such as colonoscopies and lumbar punctures, on autistic children.
I won’t lie. When I heard of the ruling last week, it brought a smile to my face, even though it was announced on the very day before my grant deadline, the very day I was in the midst of pulling an all nighter to get the grant done, the very day I was in a pretty lousy mood–tired and even more cranky and cantankerous than usual. Hearing that the man whose bad science launched a thousand quackeries had finally been declared unethical and dishonest and was on the verge of having his U.K. medical license yanked (or, to use that wonderfully British turn of phrase, struck off) brought joy to my heart, the joy that comes with seeing justice done. True, it was justice delayed–by several years, given that evidence of Wakefield’s dishonesty and conflicts of interest had been published by Brian Deer back in 2004–but it was justice nonetheless.
Yesterday, there was a bit more justice laid down upon poor, poor, pitiful Saint Andy. Yesterday, what minuscule bit of seeming scientific credibility Wakefield had left was taken away from him. Yesterday, The Lancet decided to retract Wakefield’s 1998 paper, the paper that started the whole MMR scare nearly 12 years ago. For, yesterday, published online on The Lancet‘s website was this brief message from its editors:
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 al1 are incorrect, contrary to the findings of an earlier investigation.2 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.
Let me repeat that again:
We fully retract this paper from the published record.
Quite frankly, this is utterly astonishing. I can’t recall every having seen editors of a scientific or medical journal retract a paper in this manner before. Usually when papers are retracted, it’s the authors who do the retracting, most commonly as a result of either the reports by other groups that they cannot replicate the results in the paper or allegations of scientific fraud. True, authors may not do it quite so willingly. Usually they are in a position where they have little choice but to retract if they want to try to salvage some honor. One common example is when scientific fraud is alleged, particularly when it’s not the senior author but rather one of the trainee authors who committed the fraud and the senior author didn’t catch it. In that case, the senior author will usually ask that the relevant paper(s) be retracted. Rarely, however, do the editors decide to retract a paper that they have previously accepted. Even more rarely do editors retract a paper whose publication they defended so vociferously six years earlier, even as they admitted that it was a mistake to have published it.
That’s right. Six years ago, when Brian Deer’s allegations first came to light, so serious were they that The Lancet‘s editors addressed them in an editorial, basically refusing to retract the paper while admitting that most of the criticisms leveled against it were true. Indeed, this 2004 editorial was a masterpiece of weasel words and equivocation. For example, this is what Richard Horton, the editor of The Lancet, wrote:
In the light of the public controversy surrounding this work and the allegations made to us, one could argue that more explanation could and should have been provided in the original paper. Although, with hindsight, this seems a reasonable criticism, all research papers published by all journals are inevitably concise accounts of often complicated research protocols. We do not judge that there was any intention to conceal information or deceive editors, reviewers, or readers about the ethical justification for this work and the nature of patient referral. We are pleased to have had the opportunity to clarify the scientific record over the matters raised by these serious allegations.
Of course, it’s understandable that the editors of the Lancet would be reluctant to admit their error in having accepted Wakefield’s publication. After all, there were multiple red flags in Wakefield’s study that should have set skeptical antennae a’ twitchin’ among both editors and reviewers, not the least of which was the small sample size of only 12 patients. For a finding as provocative as Wakefield’s, namely that MMR vaccination was associated with autistic regression and bowel complaints, 12 patients are nowhere near enough to conclude anything with confidence. The reason is simple. Small sample sizes are prone to spurious, seemingly “statistically significant” correlations. Small sample size wasn’t the only problem, though. The study stated that these children who experienced autistic regression had shown no signs of autism before being vaccinated. However, this claim was not based on clinical records in many cases; it was based on parents’ memories, which are particularly prone to confirmation bias. Indeed, approximately a year ago Brian Deer demonstrated that many of these children had actually showed signs of autism that had been documented in their general practitioner’s records before their having been vaccinated with the MMR vaccine. Granted, that revelation came a decade after Wakefield’s paper was published, but if you read the paper itself (courtesy of–heh–J.B. Handley and his execrable 14 Studies website), you can see that its methodological flaws are numerous. The Lancet is a high impact journal. It should have better standards. Even though the editors and reviewers couldn’t have known that the “consecutive patients” in the study were anything but consecutive, several having been cherry picked from patients whose parents believed that vaccines had caused their children’s autism and wanted to sue vaccine manufacturers, there were enough other red flags that should have led them to nix Wakefield’s manuscript.
Maybe the Lancet editors are embarrassed. They should be. After all, back in 2004, ten of the original thirteen authors retracted their support for the article and its findings. Andrew Wakefield and Peter Harvey refused to to retract. From my perspective, if the the editors had had any balls back then, they would have retracted the paper then. it would have been the right thing to do. After all, the editors all but admitted that Wakefield had violated The Lancet‘s rules on disclosure of conflicts of interest. Come to think of it, if Andrew Wakefield and Peter Harvey had had one iota of honor, they would have retracted the paper themselves, as honorable scientists do when such flaws are brought to light. Not surprisingly, Wakefield did no such thing, because he is not an honorable man.
Showing us once again what is the wrong thing to do is David Kirby, who has leapt to Wakefield’s defense. Yes, that’s exactly what Kirby does in–where else?–that repository of antivaccine pseudosience and quackery, The Huffington Post, in a post entitled The Lancet Retraction Changes Nothing. Kirby is actually correct about this, but not in the way that he thinks he is. The Lancet retraction doesn’t change the fact that Wakefield’s study was incompetently performed, riddled with undisclosed conflicts of interest, and missing critical information that would have cast doubt upon its findings. No, the retraction doesn’t change the fact that Wakefield’s work is a steaming, stinking load of fetid dingo’s kidneys. It wasn’t a case series; it was a fishing expedition to create “science” to support a legal case against MMR manufacturers, and Wakefield played it for all it was worth in the press.
But Kirby sure do write real pretty trying to convince you otherwise.
He starts with the usual complaint about our poor brave martyred St. Andy:
I believe that the public lynching and shaming of Dr. Wakefield is unwarranted and overwrought, and that history will ultimately judge who was right and who was wrong about proposing a possible association between vaccination and regressive autistic spectrum disorder (ASD).
Wakefield’s critics can condemn, retract, decry and de-license all they want, but that does nothing to stop or alter the march of science, which has come a long way over the past 12 years, and especially in the last year or two. The evidence that autism is increasing at alarming rates, and that some thing (or things) in our environment is wreaking havoc on a vulnerable one-percent of all US children is now so irrefutable that, finally, the federal government is climbing aboard the environmental research bandwagon – way late, but better than never.
Actually, I agree that history will ultimately judge who was right and who was wrong about proposing an association between vaccination and autism. In fact, it is already in the process of doing that, with study after study failing to find such an association. In any case, once again, there is almost no such thing the “autism epidemic.” The apparent increase in autism prevalence is almsot certainly a result of several factors, including widening of the diagnostic criteria back in the mid 1990s, increased awareness, and diagnostic substitution. I’ve discussed this time and time again on this blog; so I won’t belabor the point.
Next up are David Kirby’s favorite hobby horses:
There was the case of Hannah Poling, in federal vaccine court, in which the government conceded that Hannah’s autism was caused by vaccine-induced fever and overstimulation of the immune system that aggravated an asymptomatic and previously undetected dysfunction of her mitochondria. Hannah received nine vaccines in one day, including MMR.
Then there was the Bailey Banks case, in which the court ruled that Petitioners had proven that MMR had directly caused a brain inflammation illness called “acute disseminated encephalomyelitis” (ADEM) which, in turn, had caused PDD-NOS, an autism spectrum disorder, in Bailey.
Poor David. He never learns. As I’ve discussed extensively before, the way the anti-vaccine movement–and David Kirby in particular–jumped all over the Hannah Poling case was truly shameful. It is, as I have pointed out, nothing more than a rebranding of autism as a mitochondrial disease, and the Bailey Banks case does not prove that vaccines cause autism. Indeed, it’s hard not to note that somehow the anti-vaccine movement didn’t mention Banks for a long time; it only resurrected the case in the wake of the Autism Omnibus hearing that went against them. Truly, it was stupid cubed when David Kirby and his brother in antivaccine pseudoscience Robert F. Kennedy, Jr. teamed up with Generation Rescue to try to spin the Banks case to support the view that vaccines cause autism. My saying so resulted, predictably enough, in another broadside of ad hominem attacks and other invective against me by our old friend J.B. Handley.
Kirby also returns to deceptive rhetoric that he’s used many times before. Basically, he cherry picks studies in a desperate attempt to make you believe that the link between vaccines and autism is plausible. For example, he references this PLoS ONE study regarding mitochondrial disorders. It’s a series of 25 patients with autism and later determined to have mitochondrial defects. The point of the article is that there may be a subset of children with autism with mitochondrial disorders and that they have different clinical features. It’s a small study, and it does not provide evidence that vaccines cause autism. There was one child who regressed after vaccines, but, as we all know, correlation does not equal causation, and even the authors pointed out that fact.
Kirby also decides to try to spin yet another study:
And last September, a chart review of children with autism and mitochondrial disease, published in the Journal of Child Neurology, looked at 28 children with ASD and mitochondrial disease and found that 17 of them (60.7%) had gone through autistic regression, and 12 of the regressive cases had followed a fever. Among the 12 children who regressed after fever, a third (4) had fever associated with vaccination, just like Hannah Poling.
Kirby appears to be referring to this study. Again, this is a small study, and, if anything, it simply shows what we’ve known since the Hannah Poling case came to light, namely that fever can be associated with autistic regression in children diagnosed with autism and mitochondrial disorders. It says little or nothing about whether fever can cause autistic regression in a child with mitochondrial disorders and no evidence of neurological dysfunction or whether vaccines can induce autistic regression in such children. What it does say is that fever is a problem for children with mitochondrial disorders, and who is likely to get more fevers due to febrile illness, children who are vaccinated or children who are unvaccinated? In fact, the recommendation is that children with mitochondrial disorders should be vaccinated.
But let’s for a moment accept Kirby’s argument as valid–for the sake of argument, nothing more. As I’ve pointed out time and time again, Kirby’s desperate argument is in effect an admission that the anti-vaccine movement has lost, that it’s utterly failed, and that it’s original claims have been soundly refuted by science. It is an admission of defeat. After all, remember what antivaxers originally claimed a few years ago. It wasn’t that vaccines might trigger autism in a small number of genetically predisposed children. Oh, no. That wasn’t nearly grandiose enough a claim. Rather what antivaxers used to claim was that vaccines are responsible for the “autism epidemic.” Not a few children, an epidemic of autism. Indeed, the whole premise of Kirby’s book Evidence of Harm was that the thimerosal additive in childhood vaccines was fueling an “epidemic of autism, ADD, speech delay and other disorders in America’s children,” not a rare reaction in the odd child or two with an rare mitochondrial disorder. An epidemic. The same is true of the MMR, vaccine, which, in the years following Wakefield’s study, has also been blamed for an epidemic of autism. Bernard Rimland, for instance, has written:
I was the first to announce the “autism epidemic”, in 1995, and I pointed out in that article that excessive vaccines were a plausible cause of the epidemic. As you know, an enormous amount of clinical laboratory research (as opposed to epidemiological research), has been accumulated since that time, supporting my position. (I did not know then that the vaccines contained mercury, although I had been collecting data since 1967 from the mothers of autistic children, on any dental work they may have had during their pregnancy.) The evidence is now overwhelming, despite the misinformation from the Centers for Disease Control and Prevention, the American Academy of Pediatrics and the Institute of Medicine.
Blaming vaccines for the surging numbers of autism diagnoses since the mid-1990s was, of course, a classic case of confusing correlation with causation. Time and time again, we’ve seen the antivaccine movement claiming that the increase in the vaccine schedule in the early 1990s is responsible for the skyrocketing autism prevalence that was (and sometimes still is) painted in near apocalyptic terms at times. Yet now Kirby and the anti-vaccine movement are in effect arguing that if a child with a rare genetic disorder (say, mitochondrial disorders leading to symptoms) gets a certain combination of vaccines at the right time (when the moon if full perhaps?), that child might have a reaction that might lead to regressive autism. Even if this were true, the end result would be a vanishingly small number of children who would be effected, and there’s no good evidence that it is true. All Kirby has is his uninformed extrapolation based on a few carefully selected studies.
So much for the vaccines causing an “autism epidemic.” Even David Kirby seemingly admits that it is impossible, given how he’s grasping at straws yet again. I must admit, though, he’s very clever at it. He might almost have you believing that the vaccine-autism hypothesis isn’t pining for the fjords, as he swears, like a mad scientist in a B movie that he’ll “show them all”:
Another fact that gets little attention in this never-ending debate is that more than 1,300 cases of vaccine injuries have been paid out in vaccine court, in which the court ruled that childhood immunizations caused encephalopathy (brain disease), encephalitis (brain swelling) and/or seizure disorders. Encephalopathy/encephalitis is found in most if not all ASD cases, and seizure disorders in about a third of them.
If we know that vaccines can cause these injuries, is it not reasonable to ask if they can cause similar injuries that lead to autism? (Stay tuned as those 1,300 cases come under closer scrutiny).
Of course, no reputable scientist denies that rare vaccine reactions result in encephalopathy. After all, if there weren’t rare adverse reactions to vaccines, the vaccine court wouldn’t exist. It wouldn’t need to. Implying that scientists believe that vaccines never cause harm is nothing more than a strawman so large that its like is rarely seen outside of the Burning Man Festival, and Kirby’s just the guy to set the torch to it, to the oohs and ahhs of the assembled crowd of his antivaccine fans. I’d also like to know where he got the idea that encephalopathy and encephalitis are associated with “most, if not all” ASD cases. That sounds like the classic misuse of a study, as so well described by Trine Tsouderos, to me. Sadly, Andrew Wakefield and his defender David Kirby remind me more and more of the Black Knight in Monty Python and The Holy Grail taking on science:
Yep, the GMC ruling and the Lancet retraction are just “flesh wounds.”
Ironically, though, as I pointed out earlier, Kirby is right about one thing. The Wakefield retraction doesn’t change anything at all in terms of the manufactroversy regarding vaccines and autism. It’s good that the GMC ruling gave the Lancet’s editors the opening they appeared to have been looking for to retract Wakefield’s paper and save some bit of face, but it is unforgivable that they waited six years longer than they should have. In that, they’ve been cowardly, weasely, and utterly failed in their responsibility as the stewards of a high impact journal and the medical science contained therein. I guess it’s better that they finally did the right thing late rather than never, but their delay has besmirched the reputation of the Lancet for a long time to come.