Andrew Wakefield – dishonest attempt at self-justification

The movie Vaxxed is an anti-vaccine polemic that claims, despite all of the high quality contradictory evidence, that there is a link between the MMR vaccine, for mumps, measles and rubella, and autism. Furthermore, it claims that the US government is engaging in a conspiracy to hide said link. Reviews of the film have appropriately emphasized the checkered past of its director, Andrew Wakefield, a discredited ex-scientist with a history of misrepresentations. Many of the reviews point out that Wakefield is not a credible source for information on vaccines.

In a recent video posted on the Vaxxed website, Andrew Wakefield took those claims head on, mounting a passionate defense of his reputation. If anything, however, this video further shows that Wakefield is not a good source of information.

The video’s claims range from unsupported (and implausible) to blatantly false. Unfortunately for Wakefield, Brian Deer meticulously documented each step in the events, making it relatively easy to identify the problems in these claims. Unfortunately for the rest of us, Wakefield’s adherents are unlikely to check his claims, and others may also accept his word without fact-checking. It’s therefore worth going through the claims.

To hear Wakefield, he was the victim of a conspiracy mounted because he dared raise safety concerns about vaccines. But as with his book, Callous Disregard (pdf), Wakefield’s claims are ill founded. In short, there are good reasons he lost his license and his reputation as a serious scientist.

A brief review of the history of this story – in 1998, Wakefield and co-authors published a paper suggesting that the measles component of the measles-mumps-rubella (MMR) vaccine caused changes in some children’s guts, and that those changes were associated with autism.

In 2007, after extensive investigation by Brian Deer published at The Sunday Times, Britain’s General Medical Council (GMC) opened an investigation of their own to answer the question: Did Wakefield engage in serious professional misconduct?  In May 2010, the GMC found that yes, he did, and removed Wakefield from the British medical register (pdf).

Wakefield’s claims in the Allegations video can be put into three categories:

  1. there were no serious ethical violations or fraud in relation to the article he published in the Lancet;
  2. he’d done nothing wrong otherwise, measles outbreaks are not his fault, the GMC decision was generally wrong, and Walker-Smith’s acquittal shows that; and
  3. Brian Deer’s articles are a fraud motivated by a conspiracy.

None of these claims hold water.

Lancet Paper – fraud and ethical violations

 

Point 1. Referral of Children

In the video, Wakefield tries to paint the paper as the natural result of the discovery of a pattern of a syndrome among patients, saying:

[infobox icon=”quote-left”]The way in which human disease syndromes are described, whether it’s autism or Crohn’s Dissease or Asperger’s, is you have a collection of a few, a handful of patients, sometimes no more than four, sometimes as many as fifteen, where the presentation is so similar, the findings in the clinic are so similar, that these merit publication in their own right. That’s called a case series.[/infobox]

In response to the point that several of the children were involved in a litigation effort against MMR, Wakefield suggested that the parents joined the litigation effort later, and were not initially involved. But as documented by Brian Deer, in February 19, 1996, before the first referral of Lancet children, Richard Barr, the lawyer representing the plaintiffs in litigation against MMR,  sent out a private newsletter to his clients.

Deer quotes the text of the newsletter:

[infobox icon=”quote-left”]“He has deeply depressing views about the effect of vaccines on the nation’s children,” Barr said. “He is also anxious to arrange for tests to be carried out on any children . . . who are showing symptoms of possible Crohn’s disease. The following are signs to look for. If your child has suffered from all or any of these symptoms could you please contact us, and it may be appropriate to put you in touch with Dr Wakefield.'[/infobox]

Referral of many of the children examined occurred after the letter.

Deer also documented the connections between the different Lancet children involved, including siblings and friends, most of them linked to the anti-vaccine group, JABS.

It’s probably clear to readers that there is a dramatic difference between discovering a pattern by seeing, to your surprise, a set of unconnected patients presenting similar symptoms and “discovering” a pattern because a set of patients with specific symptoms and parental beliefs was solicited. Given the way many of the children were referred, it would be surprising if the parents did not claim a perceived connection to MMR. After all, they were solicited from among plaintiffs against MMR.

Wakefield claimed in the video that:

[infobox icon=”quote-left”]The Lancet Study itself arose out of seeing many of these children with the same presentation. Normal development, regression, and autism spectrum diagnosis, gastrointestinal symptoms, and bowel inflammation. It was putting that story together in one package and saying, “Here are the first twelve children that we’ve seen. This is what we find. This is remarkable, it’s consistent. It suggests the emergence of a new human disease syndrome. The parents report the regression occurred after MMR vaccine in many cases. That is now up for testing as a hypothesis. Subsequent studies should be done to actually elucidate whether that is true or not.[/infobox]

Wakefield suggested that the syndrome was discovered spontaneously rather than as a result of setting up cases and is highly misleading. The Lancet article was a study that arose because clinicians discovered a syndrome. However, it arose because Wakefield went fishing for cases that fit a pre-conceived view about MMR, autism and bowel disease.

Even worse, Deer points out that the data in these cases was highly massaged to create the appearance of a close temporal connection to MMR where in many cases, it just did not exist – developmental problems and/or bowel problems existed either before the MMR or started long afterwards.

Point 2. Conflicts of Interests, Funding from Legal Aid:

In the video, Wakefield also denied that he hid conflicts of interests in relation to payment for his involvement in the litigation. He claimed:

[infobox icon=”quote-left”]One of the allegations against me is that I had acted on behalf of lawyers, I was being paid by lawyers to do the Lancet Study. In fact, I was being paid for by a government funded compensation program to act as a medical expert. It had nothing whatsoever to do with the Lancet Study, which was paid for by the National Health Service. They payment from the Legal Aid Board was not to me initially. It was to the medical school to conduct a study, to look for evidence of measles virus in the diseased intestine of these children. That is what it specifically did.[/infobox]

This, again, is disingenuous. The lawsuit was funded by the Legal Aid Board, that’s true. But it was Barr who was running it, and Barr submitting expenses and choosing to hire and pay Wakefield. A certain sum was given for the study (pdf), but additional money was paid directly to Wakefield through a company owned by his wife.

Deer points out a protocol submitted by Barr and Wakefield was identical to one submitted to the ethics committee as part of the study, making a case that money was asked for the study from the legal aid board, whether or not the Lancet study was actually funded that way.

Whether the Lancet study was done using funds from Legal Aid isn’t the point. Wakefield was paid as a research witness in the litigation from February 1996, long before the paper (pdf). The children in the study were part of the litigation. That is a clear and direct conflict of interests that should have been disclosed. Trying to deny it is misleading.

In the Allegations Video, Wakefield claims that the editor of the Lancet knew of the payment from the legal aid board. The only available documents I have seen on this – referred to by David Lewis, an engineer engaged in an attempt to exonerate Wakefield that I will discuss later – are an exchange between Attorney Barr and Richard Horton, the Lancet editor, which Lewis claimed showed to the editor that “he and Wakefield were working together.”

But looking at the letters only shows a request for permission to use certain materials from the Lancet article, a request that was denied. The only reference to Dr. Wakefield is “We have Dr. Wakefield’s specific permission to make references to it.” That’s very different from “We are working together, and we are paying him to find things that will help our clients.” The letters do not support the conclusion Lewis withdrew from them, or Wakefield’s statement – and Horton addressed them to the GMC:

[infobox icon=”quote-left”]To the best of my recollection, I did not read the Dawbarns fact sheet or fact sheets at any time prior to the publication of The Lancet paper by Dr Wakefield & others in 1998. I certainly was not aware as a result of the exchange with dawbarns about permission to reproduce material from The Lancet that Dr Wakefield was being paid by the Legal Aid Board to advise on litigation to be brought by the parents of the children alleged to have been damaged by the MMR vaccine.[/infobox]

Point 3. Patent for a Single Vaccine: 

Wakefield also denied that he had a patent for a single vaccine. Specifically, in the video he claimed that:

[infobox icon=”quote-left”]What we had at the time was a patent, the medical school owned the patent, not me. It was a patent on a thing called Transfer Factor. It’s a naturally occurring nutritional supplement that occurs in breast milk, for example, that boosts the immune response. Whether it worked or not is another question. That’s what we sought to try and find out. It boosts the immune response to an infection like measles. This could not prevent children from getting measles, so it didn’t act like MMR at all. What it did was to help them clear the virus once they became infected. It could never have competed with MMR vaccine. Never, because it did not work in the right way.[/infobox]

The problem is that the patents in questions refer to this as a measles vaccine. For example, in a 1997 patent, before the publication of the paper, it says, “what is needed now is a safer vaccine …. I have now discovered a combined vaccine/therapeutic agent which is not only most probably safer to administer…”

In another place, Wakefield said: “such a composition may be used as a measles virus vaccine.”

Here is a friendly suggestion to Andrew Wakefield. If you want to claim your patent was not for a single measles virus vaccine, it should not say that it can be used as a single measles virus vaccine.

Andrew Wakefield had a patent for a substance that he claimed could serve as a single measles virus vaccine before the publication of the Lancet paper and before he went to the media and claimed the MMR was unsafe. He did not disclose it. When he says otherwise, it’s a blatant misrepresentation of the facts.

Point 4. Ethics Committee Approval: 

Another claim Wakefield made about the Lancet paper was related to ethics committee approval. He said:

[infobox icon=”quote-left”]The other reason is that it was claimed by Brian Deer, and subsequently the GMC, that there was no ethical approval, in America, investigational or institutional review board approval for the study itself. It was a clinical study. It didn’t need ethical approval, but the analysis of the biopsies from the intestine did. There was ethical approval. That was in Deer’s hands when he made the allegation, and he deliberately withheld that information from the General Medical Council. It was an obstruction of justice.[/infobox]

This statement is simply implausible on its face. The GMC clearly concluded that the paper did require ethics committee approval (though some of the authors, in their defense, claimed they thought differently). But in terms of the Lancet paper, that was not the only issue. The problem is that the paper did claim ethics committee approval – falsely.

In a High Court decision by Justice Mitting that Wakefield speaks positively on (more on that, later), the Judge said (paragraph 153):

[infobox icon=”quote-left”]The wording in the published paper which neither Dr. Murch nor Professor Walker-Smith saw before publication was,

“Ethical approval and consent. Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.”

This statement was untrue and should not have been included in the paper.[/infobox]

In short, the judge made it clear that the paper did, in fact, lie about having ethics committee approval.

I’ll add that if there was an ethics committee approval for any part, there was nothing stopping Wakefield, Murch, and Walker-Smith from submitting it to the GMC. It was their defense.  Blaming Deer on this point is strange.

Point 5. David Lewis did not Prove Wakefield Committed No Fraud

In the Alleged video, Wakefield stated that David L. Lewis performed a reanalysis of the of the data and found no fraud. He refers, apparently, to Lewis examining reports summarizing the results of intestinal biopsies of the Lancet children.

Brian Deer actually responded to Lewis’ claims, pointing out that the claims of fraud did not rely on the biopsy records Lewis examined, but on the way the children were admitted and the ways their histories were doctored to allege autistic regression in the 14 days period after MMR – something the data did not support.

Another problem – testified to later by Nicholas Chadwick, Wakefield’s former research assistant who tested samples from the Lancet children – was that although Wakefield was claiming that the measles virus specific to the MMR vaccine persisted in the gut and caused autism, Chadwick’s tests on the gut biopsy samples of the Lancet children found no measles virus at all. And Wakefield knew that.

In short, Lewis’ analysis had nothing to do with the basis for the fraud allegations against Wakefield, which stand unchallenged.

That said, since Wakefield graciously submitted the data and Lewis made it available, Deer had the data both analyzed by experts and made public (pdf).

The results did not support Wakefield and Lewis’ claims. The experts the reports were shown to found them overwhelmingly normal. In other words, these report too suggest the results in the Lancet paper were very, very problematic.

Other issues for Andrew Wakefield

 

Drawing blood at a birthday party:

One of the allegations against Wakefield was that he drew blood samples from children at a birthday party for his son, and paid the children five pounds (about US$10.00) each for the samples.

In the video, Wakefield said on that:

[infobox icon=”quote-left”]It was done with fully informed child and parental consent. Fully informed. It was entirely ethical. It was no worse, for example, than going to CVS and having a shot. In fact, probably substantially better. It was done by a highly experienced general practitioner, not by me. There were no problems at all.

The only problem was that it did not have an approval from the Hospital Ethics Committee. That does not make it unethical. It was done, as I say, with fully informed child and parental consent. That’s the story. Do I regret it? Yes. Not because it was unethical, it wasn’t, but because it gave the General Medical Council a concrete reason for them taking away my license. It was a mistake, and if I did it again, I would do so with the appropriate ethical approval, and so therefore, it’s something I regret.

Was it at any stage unethical? No.[/infobox]

This reads as “I’m not sorry I did it, I did nothing wrong, I am sorry I got caught.”

In Britain, paying individuals for blood samples or blood draws is unheard of.  Paying the children violated this norm.

Further, ethics committees exist to protect human subjects from unjustified experiments, experiments without a benefit to justify the risk. Andrew Wakefield needed ethical approval before collecting blood for a research purpose.

It’s not his call whether it was ethical or not; boards exist exactly because the researcher’s point of view on this is compromised. Wakefield doesn’t seem to understand why this form of accountability is needed. He still doesn’t. There’s nothing indicating that if he thought he could get away with it, he wouldn’t perform procedures of children without ethical approval again, at his own judgment. Quite the opposite.

That makes me, at least, grateful that he can no longer work as a researcher – and worry whether, in spite of not having a license, he is in any way involved in care of any children, autistic or otherwise.

And his claim here that there were no problems is Contradicted by the story Wakefield told at a meeting of parents of autistic children in 1999, where Wakefield ridiculed the birthday-party children for fainting and vomiting. That was a large part of the GMC’s criticism.

The Walker-Smith Decision does not Exonerate Wakefield:

Wakefield claimed that the High Court decision in the case of Walker-Smith exonerates him. He said:

[infobox icon=”quote-left”]Professor Walker Smith did appeal, and at that appeal, the first time this case had ever come before a proper judiciary, a proper judge. Then, the judge destroyed the General Medical Council’s decision. He said effectively they were incompetent.

They were not in a position to judge the evidence, that they made mistakes, they got the facts wrong, they misrepresented the evidence, and worse of all, they were biased. They had made up their minds from the outset that we were guilty. He completely overturned their decision, and said in effect this must never happen again.[/infobox]

I have closely read the Mitting decision. It did not in any way exonerate Andrew Wakefield. I previously enumerated the reasons why in this article. The decision is critical of the GMC’s analysis –mostly because it found it did not well explain its conclusions. It nowhere suggests the GMC panel was biased, or misrepresented evidence, though it agrees with some of the GMC’s factual findings.

As I outline in the article, the reason the decision does not exonerate Wakefield is that many of the allegations were specific to Wakefield. For example, there was no allegation Walker-Smith hid conflicts of interests, nor that he withdrew blood.

And even on the heart of the allegations – the finding that Walker-Smith did research without ethics committee approval – the Judge found that it was unclear whether Walker-Smith’s intent was to engage in medical practice or to do research (only research would require ethics committee approval). But in relation to Wakefield it repeatedly highlights that Wakefield’s goal was research (see, for example, paragraphs 19, 42 and 98). In short, Wakefield was acting as a researcher – and as such required ethics committee approval which he did not have.

Further, Judge Mittings acquitted Walker-Smith from the allegation that a false statement on ethics committee approval was included in the paper because of Walker-Smith and Murch’s argument that they asked Wakefield to fix it and trusted him to – paragraph 159 says:

[infobox icon=”quote-left”]…it was not misconduct for him, Dr. Murch or Dr. Thomson to invite a research colleague, Dr. Wakefield, to correct a misleading statement in the draft and leave it to him to do so. Because the panel made no finding on that issue, its reasoning is inadequate.[/infobox]

In other words, Walker-Smith was acquitted because the GMC did not clearly reject his claim that he trusted Wakefield and Wakefield proved untrustworthy. That’s not an exoneration of Wakefield.

Yes, Wakefield is Responsible for Measles Outbreaks in the British Isles

The last point, and a very troubling one, is that Wakefield in the Allegations video and elsewhere tried to absolve himself from responsibility for the measles outbreak by claiming the fault was the British Government’s for withdrawing the single measles vaccines and Merck for stopping production of singles measles vaccines in favor of MMR. This is not a new claim for Wakefield. He made it in April 2013, at the height of the measles outbreak in the UK.

Wakefield says:

[infobox icon=”quote-left”]That deprived parents of the choice. They were still concerned about MMR, so they didn’t vaccinate, measles then came back. It was entirely [the government and Merck’s] fault.[/infobox]

Really. No, really. You make unsupported claims that MMR is dangerous. You write a problematic paper claiming it and say it in the press. You present yourself in the press as having scientific basis for saying it.  Even though your own paper did not show it, not even after you massaged its facts, and you had to know that the timeline, at least, was problematic.

In other words, you create a baseless scare about MMR, and push people towards single vaccines. And it’s someone else’s fault that people reject MMR when single vaccines are not available?

Single vaccines were no longer available. In his book on the MMR scare, Michael Fitzpatrick, a UK physician in general practice,  explains Britain’s decision to reject single vaccines as motivated by public health. As to Merck, Wakefield seems to think making the combined vaccines means making the single vaccines individually and then pouring them into a big vat and mixing. I asked Dr. Paul Offit, an actual vaccine expert, if there’s more involved. He said:

[infobox icon=”quote-left”]Much more. That’s why it’s so hard to make combination vaccines. You have to make sure that there is no interference between the buffering and stabilizing agents used to make each vaccine. Which is why you have to prove that the antibody response is not more than 10% lower with the combination vaccine as compared with the individual components. This is the so-called non-inferiority rule of the FDA.[/infobox]

In other words, Merck does not have a stash of individual measles, mumps, and rubella vaccines ready to deploy as single vaccines.

Single vaccines were no longer easily available in the 1990s. Wakefield contributed to unjustified fears about MMR, the combined vaccine. He cannot blame others for the measles outbreak when people stopped taking advantage of the safe, effective combination vaccine available. He scared them off it. He is responsible, at least in part (the media and others share the blame), for measles coming back to the British Isles, for its harms and deaths.

Conspiracy theories against Brian Deer

 

Wakefield, understandably, is hostile toward Deer, who exposed his misdeeds. In this video it is expressed as a series of unsubstantiated allegations and complex conspiracy theories about Deer.

The first claim that Wakefield makes is that Deer’s investigation was instigated not by Deer himself, but some shadowy others. If I understand correctly, he suggests a combination of factors: Deer worked for Rupert Murdoch, and Deer was also involved with GSK (who supplied one version of MMR used in the U.K.), and Rupert Murdoch’s son was on the board of GSK. A somewhat complex web of interactions, that is not actually supported and appears to exist only in Wakefield’s mind.

He claims a general conspiracy theory: “How could a single journalist achieve what Brian Deer achieved so effectively? It was the will of the government, and it was the will of the pharmaceutical industry, and it was the will of the media.”

Given the rest of the claims and the problems in them, more than Wakefield’s opinion or word is required here.

Wakefield provided no evidence that Rupert Murdoch had any control over Deer, and in his response to Wakefield’s unjustified lawsuit against him, Deer claimed otherwise (pdf).

Wakefield provided no evidence for a link between Brian Deer and GSK, and Deer says there isn’t one:

[infobox icon=”quote-left”]To the best of my knowledge, I’ve had no contact at all with GlaxoSmithKline in 30 years, apart from a phone call to a press officer about 10 or 11 years ago.” (personal communication, May 16, 2016). [/infobox]

James Murdoch did not join the board of GSK until 2009. In other words, five years after Brian Deer started investigating Wakefield. So that claim, too, doesn’t hold water. (Murdoch left GSK in 2012.). Brian Deer said he had never met, or spoken to, James Murdoch.

Wakefield did not show Murdoch cared one way or another about the way publicity on MMR would work. Or that it was the will of the media to discredit him, In fact, in the first years after the 1998 press conference many articles appeared supportive of Wakefield’s claims, in contrast to the appearance his claims in this video suggest of an orchestrated, universal attack from early on (see here, here and here).

The criticism of Wakefield seemed to start after Deer uncovered his misdeeds. It doesn’t look like it was the will of the media. It looks like the result of Wakefield’s actions.

Finally, Wakefield claimed that government also wanted this, to protect the vaccine program. That claim is a little strange. It’s unclear why the British Government – with a single-payer national health insurance, paid for by them – would not care about rising rates of autism and the costs they may impose, even though, if Wakefield’s claims were true, they had a way to both prevent autism and prevent infectious disease. If Wakefield wants to claim this, again, he should provide some evidence. On its own, as it stands now, this is an unsupported conspiracy theory.

So, what have we?

 

We have a set of claims that range from unsupported to blatantly false by a discredited scientist with a history of serious ethical violations and misrepresentations. Andrew Wakefield is clearly – and understandably – attempting to clear his name. But doing so in this dishonest manner only reinforces the starting point.

Andrew Wakefield is not a credible source on vaccines. Or on his past.

Frankly, I don’t think I’d want to buy a car from him, either.

Dorit Rubinstein Reiss

This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law. 


Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.