Recruitment of Wakefield’s study subjects…part 1

20 Oct

It has already been well established that Andrew Wakefield was employed by Dawbarns, a lawfirm working with families bringing forward claims of vaccine damage from MMR. Brian Deer made this clear in his investigative reporting starting in 2004.

Even with that, I must say I was surprised and dismayed to read it again and in much greater detail in the GMC transcripts.

Mr. Wakefield has asserted over the years that the children for the Lancet study came through “formal channels”. He denied the possibility of litigation bias in a letter to the Lancet.

Amongst the myriad questions left open is why did a group of parents of disabled children seek out Mr. Wakefield’s team when that team had no particular expertise in autism. Why did families from all over the U.K. and beyond seek out the Royal Free Hospital?

There is evidence elsewhere in the transcripts of Mr. Wakefield’s direct involvement with recruiting some children for his study, but here we can see how the law firm was actively recruiting children, and that Mr. Wakefield was aware of this.

For example, here is a section from the transcripts from day 3 of the hearings. This is where Ms. Smith was laying out the case against Mr. Wakefield before testimony was started.

Let’s first put the following letter into perspective on time. The letter is from August 1996. 1996 was two years before the Lancet paper was published. Earlier that year (in February) Mr. Wakefield had agreed to work as an expert in the MMR litigation. The Fall of 1996 was when the Lancet 12 children were seen at the Royal Free. After this initial group of children, more (over 70 total) children were seen at the Royal Free for suspected Gi complaints and regression.

Ms. Smith’s comments are in bold. The letter from Mr. Barr are blockquoted.

If I can just read through it, this is a letter to Dr Wakefield from Mr Barr, the solicitor for the claimants:

Dear Andy

I refer to the telephone message left … and I am writing to confirm that at long last the Legal Aid Board has now given authorisation for the pilot study. The limit is £55,00 which does include the setting up costs.

I think we need to have a meeting about the mechanics of running the study because obviously we both have different roles to play and we also need to make sure that the investigation is as effective as possible both from your point of view and ours.

As I mentioned on the telephone the only slight cloud is that the Legal Aid Board rather hoped that within the £55,000 you would be able to include preparing us a written over-view in relation to vaccine damage. We have discussed this and I don’t know whether it is impertinent to suggest that you should do it within that funding bracket.

We also need to make sure that cases are properly selected for the pilot study. Obviously only legally aided children can be included (we have details of cases where legal aid has either not been granted or has not been applied for). Again a meeting might help to sort those out. For all the cases that we have obtained legal aid we have already put in hand obtaining records. In many cases we already have the complete set.

I assume that for the purposes of the pilot study you would like us to supply a full set of medical records and as much information about the cases as you can get hold of.

Then there is reference to two of the vaccine support groups who were concerned about a forthcoming MMR campaign, and:

“When we meet I would like to discuss with you and perhaps engage in further correspondence with Dr Salisbury/The Committee on Safety of Medicines”,

and it then goes into some details and requests information about the vaccine trials.

That letter is followed on in terms of tracing the story through. That is in August 1996 and in September 1996 Dr Wakefield is referred to in another of the newsletters that I have already gone to, again produced by the solicitors in the MMR litigation and again sent to Mrs 12. That is at page 189.

There is so much in this letter of interest, but I will pull out one fact: Mr. Barr was sending newsletters out informing people about the work starting at the Royal Free, including “Mrs 12″, the mother of child 12 of the Lancet study.

There was certainly an effort to recruit children to Mr. Wakefield’s team, and Mr. Wakefield was aware of this.

Mr. Wakefield has asserted that none of the children in the Lancet study were involved in litigation at the time of that research. I do not know what criteria Mr. Wakefield uses for “involved in litigation”, but it is clear that at least one (and from other evidence it appears more like 4 or five) of the Lancet 12 were working with Mr. Barr and his lawfirm at Dawbarns at the time of the study.

Ms. Smith also discussed a September 1996 newsletter from Dawbarns. This was at the same time that Mr. Wakefield was applying for ethical approval for his study at the Royal Free. Here is a section of that newsletter:

Autism and inflammatory bowel disease

A substantial number of children referred to us are suffering from chronic stomach problems and/or have developed autism-like symptoms. Our own researches indicate that these two conditions may well have been caused by the MMR/MR vaccines and that they may well be linked.

We are trying to put together as much information as possible about the apparent link between these two conditions and the vaccines. If you have any information, or know of other families with children who have one or other of these conditions (or both) following vaccination we would be very interested to hear from you. If your child has the condition(s) and you have not yet received the fact sheet produced by Dr Andrew Wakefield, do contact us.”

It was no coincidence that the children reported in the 1998 Lancet paper claimed regression, GI complaints and many blamed the MMR vaccine.

Was there “litigation bias” and a strong measure of self-selection in the Lancet 12? Absolutely. Was Mr. Wakefield aware of this? Yes. Did he make this clear to the public, or even his own colleagues? No.

And we have yet to discuss what active role Andrew Wakefield himself took in recruiting study subjects to the Royal Free.

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10 Responses to “Recruitment of Wakefield’s study subjects…part 1”

  1. Liz Ditz October 20, 2010 at 04:47 #

    1. Sully dear I think you need to take a break — several incomplete sentences

    Here is a section from the transcripts from

    First: this confirms that Mr. Wakefield was in the employ of Dawbarns at the time he was

    2. Perhaps you could clarify what the bold text signifies?

    3. And are the last three quotes from something? It’s not clear.

  2. daedalus2u October 20, 2010 at 15:16 #

    The point of this letter is that contrary to what Wakefield said about the children in the Lancet study, this funding is only for children referred to Wakefield by Legal Aid.

  3. Sullivan October 20, 2010 at 18:32 #

    Liz Ditz,

    all I can say is “oops”. I hit publish rather than save draft. I hope it is a bit better laid out now.

    daedalus2u,

    Much of Mr. Wakefield’s defense involves the idea that the children in the Lancet study were not part of the LAB funded project. He got NHS to fund the research activities on the Lancet 12.

    Mr. Wakefield’s argument did not stand up to scrutiny at all. The fact that he diverted funds to another project doesn’t exactly put him in a good light, for one thing. It is amazing how closely the Lancet study fits the description of the planned LAB study, and how it doesn’t fit at all the study which had ethical approval.

  4. Brian Deer October 21, 2010 at 13:43 #

    There’s absolutely no question whatsoever: the Legal Aid Board commissioned the “clinical and scientific study”, to use their contract words, which was submitted by Wakefield to the Lancet in two papers, one of which was rejected.

    I see in another LB/RB article that the Olmsted/Blaxill book hitches its wagon to Wakefield. I would say that the few drug industry observers who I imagine follow such things must be hooting and backslapping with delight.

    Wakefield betrayed some 1,500 families in the UK, and some 5,000 in the USA. Last week, I saw his “book” in the US. Not a shred of material truth to be found within it.

    • Sullivan October 21, 2010 at 19:32 #

      Brian Deer,

      Mr. Wakefield caused damage to far more than 5,000 families in the U.S..

      It is very clear that Mr. Wakefield’s defenses against the charges were, well, creative.

  5. buck October 21, 2010 at 20:47 #

    6 other comments, very impressive.

  6. Kev October 21, 2010 at 21:04 #

    Quality not quantity Buck. Thats the charm ;)

  7. Dawn October 22, 2010 at 12:20 #

    @buck: so the number of comments rates the quality of a post? I didn’t know that. Guess I need to comment more, then. I often don’t comment because the posts are generally excellent and I have nothing to add.

    SOOOOO…Sullivan: great post. Nicely worded (especially after the corrections from draft…grins). Wakefield is STILL a liar. Surprise, surprise.

    (need more comments, buck? I can break each paragraph into a comment and that’ll make the count higher if that’s important).

  8. stanley seigler October 22, 2010 at 17:30 #

    [ref say] The emperor is not only naked — his subjects have hidden his clothes in order to further their own careers.

    not sure just where to post this ref…guess under this thread as good as any…

    full disclosure: i do not believe VAXes cause autism…OTOH do not believe Big Pharma either…

    stanley seigler

    ref xxxxxxxxxxxxxxxxxxxxx

    What Research Can You Believe? By John M Grohol PsyD

    [CLIPS]

    http://psychcentral.com/blog/archives/2010/10/19/what-research-can-you-believe/

    There’s a fascinating article in the Nov. 2010 issue of The Atlantic by David H. Freedman that examines the world of medical research and that suggests much of our empirical, research-based knowledge may be flawed.

    …this article suggests that the problems with peer-reviewed research go far deeper than simple for-profit bias. Scientists are biased in many, many ways (not just for monetary gain). And this bias inevitably shows up in the work they perform — scientific research.

    However, here’s the real troubling aspect…We think of “respectability” of a journal as some sort of sign of a gatekeeping role…that studies appearing in the most prestigious journals must be fundamentally sound.

    But that’s simply not true. The emperor is not only naked — his subjects have hidden his clothes in order to further their own careers.

    The full article is worth your time: Lies, Damned Lies, and Medical Science

    http://www.theatlantic.com/magazine/print/2010/11/lies-damned-lies-and-medical-science/8269

    [END CLIPS]

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