Andy Wakefield exonerated because John Walker-Smith won his appeal? Not so fast there, pardner…

I sense a disturbance in the antivaccine crankosphere.

Actually, maybe “disturbance” is the wrong word. Unabashed whooping it up is closer to correct. High-fiving is perhaps a better term. Or maybe partying like it’s 2005. The question, of course, is what is the inciting event was that sparked such widespread rejoicing in the antivaccine world. I’ll give you a hint. It has to do with the hero of the antivaccine movement, the man who arguably more than anyone else is responsible for the MMR scare that drove down MMR vaccine uptake in the UK to the point where measles, once vanquished, came roaring back. Yes, we’re talking about Andrew Wakefield, whose incompetent and now retracted research launched a thousand biomedical quacks. (Actually, that’s probably an underestimate.) However, we’re not talking about Andrew Wakefield directly. Rather, we’re talking about Professor John Walker-Smith, one of the co-authors of Andrew Wakefield’s now rightly discredited 1998 Lancet paper. The anti-vaccine crank blog is going wild with the news that Professor Walker-Smith has succeeded in his appeal of the General Medical Council’s decision that he should be struck off the medical record along with Andy Wakefield:

A High Court judge quashed the finding of professional misconduct against Professor Walker-Smith, who had carried out some of the tests for the controversial paper that suggested a link between the MMR vaccine and autism.

Mr Justice Mitting also called for the reform of the General Medical Council’s disciplinary hearings after the lengthy battle by Professor Walker-Smith to clear his name.

The Wakefield paper prompted a nationwide scare over the safety of the jab after the study of 12 children was published in the medical journal The Lancet.

On AoA, we’ve been treated to some articles with titles like this:

The full ruling can be found here. Let’s dig in, shall we? As usual, what the antivaccine movement is promoting and what is in the ruling are not necessarily the same thing. If there’s one thing that’s obvious from the outpouring of verbiage from various antivaccine blogs, Twitter feeds, and press releases, it’s that the antivaccine movement somehow thinks that this decision exonerates Andrew Wakefield, too. Let’s disabuse them of that delusion right now, shall we? According to Mr. Justice Mitting:

At a press conference, which Professor Walker-Smith did not attend, convened to accompany publication, Dr. Wakefield stated publicly the view which he had previously expressed privately to Professor Walker-Smith that he could no longer support the giving of MMR vaccine. The joint view of Professor Walker-Smith and Dr. Murch, stated in a letter to Dr. Wakefield on 21st January 1998, was that it was inappropriate to emphasize the role of MMR vaccine in publicity about the paper and that they supported government policy concerning MMR until more firm evidence was available for them to see for themselves. They published a press release to coincide with publication stating their support for “present public health policy concerning MMR”. Dr. Wakefield’s statement and subsequent publicity had a predictable adverse effect upon the take up of MMR vaccine of great concern to those responsible for public health. There is now no respectable body of opinion which supports his hypothesis, that MMR vaccine and autism/enterocolitis are causally linked.

Correct. There is no respectable body of opinion supporting Wakefield’s hypothesis that the MMR is somehow linked to autism or the entity Wakefield made up called “autistic enterocolitis.” It’s rather annoying that Mitting would refer to it as a “body of opinion.” One can only speculate that it’s his legal background that leads him to use this particular phraseology. No scientist would. Scientists would (and do) point out that not only is there no good scientific evidence supporting Wakefield’s hypothesis, but there is a lot of evidence that falsifies his hypothesis. There’s a reason why Wakefield is viewed with such contempt in the scientific world. Actually, there are multiple reasons, not the least of which is that Wakefield is an incompetent scientist willing to commit research fraud to provide evidence for trial lawyers to use in lawsuits against vaccine manufacturers, a plot that Brian Deer uncovered and described in excruciating detail and with excruciatingly detailed documentation. This ruling says nothing about that; it’s primarily about methodology and Mitting’s legal ruling that the GMC didn’t adequately explain the rationale behind its findings that Walker-Smith committed professional misconduct. Mitting’s decision also relies a lot on his clearly poor understanding of medical research issues. (More on that below.)

It’s a simple fact, though, that Mitting’s decision regarding has nothing to do with whether Wakefield is a fraud or a pseudoscientist or not. Nor does it have anything to do with the question of whether vaccines, specifically the MMR vaccine, cause autism, as much as Wakefield’s many apologists would like to convince people otherwise. In fact, as I’ve pointed out before, Wakefield’s being struck off the British medical registry has nothing to do with the validity of the science. Even if Wakefield had prevailed and been allowed to keep his medical license, his claimed findings that vaccines cause autistic enterocolitis and/or autism would have been just as bogus. Legal rulings are not science. They can be based on science, but often they are not. It’s nice when they don’t go against science and nicer still when they resoundingly agree with science, but such is not always the case. To try to argue that a legal ruling such as the one regarding Professor Walker-Smith exonerates Wakefield is an even worse folly than arguing that his being struck off necessarily proves he is a quack. He’s an antivaccine quack based on science; it matters not what the courts say.

Admittedly, I haven’t paid much attention to Professor Walker-Smith. Back when I wrote about Andy Wakefield being struck off, I said very little, if anything about Walker-Smith. The reason, of course, is that I viewed the Walker-Smith decision as being at best peripheral. I didn’t know enough about him to decide for myself whether the GMC decision was justified or not. Still, it’s useful to look at the court’s decision to see why it concluded that Walker-Smith didn’t deserve to be struck off.

The first thing that needs to be considered is a dichotomy. John Walker-Smith appealed the GMC decision. Andrew Wakefield did not. Why not? It’s hard to say. Was it because he was too busy being the medical director of the quack clinic Thoughtful House in Texas? After all, at the time he was already making plenty of cash without a medical license. There was no need for him to appeal, which would cost a lot of money and effort. He had already left England anyway, his reputation trashed long ago. In contrast, Professor Walker-Smith appears to have had more reason to fight. He had stayed behind and, unlike Wakefield, who had never been particularly respected, Walker-Smith had been highly respected in his field. There was a lot more motivation for him to try to salvage his reputation.

In any case, here is the conclusion of the appeal decision:

For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel’s overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion. Miss Glynn submits that the materials which I have been invited to consider would support many of the panel’s critical findings; and that I can safely infer that, without saying so, it preferred the evidence of the GMC’s experts, principally Professor Booth, to that given by Professor Walker-Smith and Dr. Murch and by Dr. Miller and Dr. Thomas. Even if it were permissible to perform such an exercise, which I doubt, it would not permit me to rescue the panel’s findings. As I have explained, the medical records provide an equivocal answer to most of the questions which the panel had to decide. The panel had no alternative but to decide whether Professor Walker-Smith had told the truth to it and to his colleagues, contemporaneously. The GMC’s approach to the fundamental issues in the case led it to believe that that was not necessary – an error from which many of the subsequent weaknesses in the panel’s determination flowed. It had to decide what Professor Walker-Smith thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions fell outside the spectrum of that which would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question is an error which goes to the root of its determination.

As you can see, the decision all boils down to the question of research and whether Walker-Smith thought he was doing research or actually treating autistic children using interventions that were clinically indicated. If the interventions were clinically indicated, then it could be argued that he did not commit professional misconduct. If the interventions were done with the knowledge that they were being done for research purposes rather than to treat the children, then Walker-Smith is guilty of misconduct. The reasons, of course, are the lack of ethical committee approval yet, as is discussed in the decision:

At the heart of the GMC’s case against Professor Walker-Smith were two simple propositions: the investigations undertaken under his authority on eleven of the twelve Lancet children were done as part of a research project – Project 172-96 – which required, but did not have, Ethics Committee approval; and they were clinically inappropriate. Professor Walker-Smith’s case was that the investigations were clinically appropriate attempts at diagnosis of bowel and behavioural disorders in children with broadly similar symptoms and, where possible, treatment of the bowel disorders or alleviation of their symptoms. The GMC’s case was that he was conducting research which required Ethics Committee approval. His case was that he was conducting medical practice which did not. Accordingly, an unavoidable and fundamental question which the panel had to answer was: what is the distinction between medical practice and research?

In light of this introduction, what follows is profoundly contradictory in that the judge acknowledges that what Walker-Smith did could be reasonably viewed as research, but exonerates him because it could also be viewed as therapeutic:

The panel made no express finding on this issue and cannot have appreciated the need to do so. It was not helped by the premise upon which the GMC’s case was founded. There was a good deal of evidence, to which I refer in greater detail below, that Professor Walker-Smith and his team were undertaking what any reasonable body of medical practitioners would categorize as research – but also that he intended and genuinely believed that what he was doing was solely or primarily for the clinical benefit of the children. When such an issue arises, a panel will almost always have to determine the honesty or otherwise of the practitioner.

Justice Mitting then lists facts supporting and negating the proposition that what Walker-Smith was doing was research. I must admit, I find some of the “facts negating’ to be questionable. Particularly bizarre was Mitting’s listing of a fact that no parent other than one was required to sign the consent form in the proposals submitted to the Ethics Committee or in the revised form approved by it. Well, duh! That was part of the problem, now, wasn’t it? You know? Doing research without having obtained adequate informed consent from the parents?

Also rather odd was Mitting’s other reasoning that “none of the five clinicians involved in the investigation of the Lancet children who gave evidence to the panel considered that they were following Project 172-96.” So what? The children’s information and clinical histories ended up being used in Wakefield’s Lancet paper. I suppose one could argue that Walker-Smith was an unwitting dupe of Andy Wakefield an therefore was not guilty of research professional misconduct, but, if that’s the case, it’s hardly flattering to Walker-Smith. it’s also hard to imagine what clinical indications existed to subject these children to lumbar punctures. As a clinician, I always had a hard time figuring out how Wakefield, Walker-Smith, and the rest justified doing lumbar punctures on these children.

The implications of Mitting’s ruling are frightening in their potential. Think about it. Basically, if his ruling stands, it’s hard not to wonder whether it’s open season on human research subjects in the UK. As long as the physician can construct a quasi-legitimate-sounding rationale that he can point to aside from a research protocol for doing research-related tests on human subjects, he apparently doesn’t need to get ethical approval anymore. He can cite Mitting’s ruling that, as long as he doesn’t think he’s doing research–even if that is incorrect–then he’s not, and the GMC can’t do anything about it. So much for the Helsinki declaration! Similarly, his “any reasonable physician” test fails spectacularly as well, at least in the way he applied it. “Any reasonable physician” would not subject autistic children to a battery of invasive tests including lumbar punctures for dubious clinical reasons. Those tests were quite correctly judged by the GMC to have been ordered for research purposes rather than for routine clinical care. Autism quacks in the UK have good reason to rejoice. As it stands, one has to wonder whether they can now get away with essentially anything.

Of course, none of this stops the antivaccine movement from lapsing into full mental jacket conspiracy mode. For instance, our old friend Ginger Taylor, speaking for the Canary Party, issued a press release:

“It is quite obvious to me that James Murdoch, Brian Deer and GlaxoSmithKline orchestrated the smear attack on Dr. Andrew Wakefield,” said Ginger Taylor, executive director of the Canary Party. “A judge has now ruled that the GMC hearings were a farce. Parents are waiting for journalists to find their spine and start some honest reporting on the character assassination of doctors that is blocking medical treatments for vaccine injured children, and the role that GSK and Merck may be playing to protect their profits on the MMR vaccine. The Canary Party honors and stands by doctors of integrity like Prof. Walker-Smith, who continue to fight and defend their hard-won reputations for going the extra mile to investigate and improve the chronic, difficult-to-treat cases that now permeate our society.”

Uh, no.

I do love the conspiracy mongering, though. From my perspective, Judge Mitting’s decision strongly implies that, rather than being involved in Wakefield’s professional research misconduct, Walker-Smith was an unwitting dupe. Neither conclusion speaks particularly well of Walker-Smith, but I suppose it’s better to be an honest dupe than a dishonest research cheat. Personally, I’d rather be neither. No matter how hard the antivaccine movement tries to spin this as some sort of exoneration of its hero Andy Wakefield, it’s not.