Left Brain Right Brain

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.

For those who have followed the story of Andrew Wakefield, the fact that he had multiple conflicts of interest is not news. The subjects in his now retracted 1998 paper in The Lancet were far from a random sample of autistics. They were even far from a random sample of autistics with GI problems. Brian Deer has made this very clear. The GMC ruled that it is clear that Andrew Wakefield was fully aware of the biased nature of these children.

But, Brian Deer was not the first to catch on. A letter to the Lancet in May 1998, a few short months after the now retracted Wakefield paper was published, a letter to the editor was published. It was by a Mr. Rouse, a public heath professional:

“Sir – After reading Andrew Wakefield and colleagues’ article I did a simple internet search and quickly found the Society for the Autistically Handicapped. I downloaded a 48 page fact sheet produced for the Society by Dawbarns, a firm of solicitors in King’s Lynn.

It seems likely then that some of the children investigated by Wakefield et al came to attention because of the activities of this Society and information from parents referred in this way would suffer from recall bias. It is a pity that Wakefield et al do not identify the manner in which the 12 children investigated were referred (e.g. from local GPs, self-referral via parents, or secondary/tertiary or international referral). Furthermore, if some children were referred directly or indirectly because of the activities of the Society for the Autistically Handicapped, Wakefield should have declared his co-operation with that organisation.”

It was so close to exposing the truth, but there would be another 6 years before Brian Deer would reopen the question and show that Andrew Wakefield did indeed have serious conflicts of interests (as well as many ethical failings) in the Lancet paper.

Mr. Rouse stressed the “Society for the Autistically Handicapped”, which Mr. Wakefield was able to claim no association with. Here, read the Wakefield response for yourself. The first two paragraphs refer to other letters to the Lancet, I am only showing the response to the Rouse letter:

A Rouse suggests that litigation bias might exist by virtue of information that he has downloaded from the Internet, from the Society for the Autistically Handicapped. Only one author (AJW) has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board. These children have all been seen expressly on the basis that they were referred through the normal channels (eg, from general practitioner, child psychiatrist, or community paediatrician) on the merits of their symptoms. AJW had never heard of the Society for the Autistically Handicapped and no fact sheet has been provided for them to distribute to interested parties. The only fact sheet that we have produced is for general practitioners, which describes the background and protocol for investigation of children with autism and gastrointestinal symptoms. Finally all those children referred to us (including the 53 who have been investigated already and those on a waiting list that extends into 1999) have come through the formal channels described above. No conflict of interest exists.

Much discussion went into this exchange. There even appears to be two versions of the Rouse letter.

Mr. Wakefield argued that his response was factually correct. That he responded to some specific questions raised by the Rouse letter. I am reminded of the courtroom oath in the United States, that one must tell the truth, the whole truth and nothing but the truth. Mr. Wakefield seems to avoid “the whole truth” here and elsewhere.

Here is what the prosecution had to say about Mr. Wakefield’s response:

So even at that stage, we suggest that Dr Wakefield failed to set out in straightforward terms the nature of his involvement with the litigation and the receipt of funding, because he says he has never heard of the Society for the Autistically Handicapped – well, fair enough – but he does not state that he had heard of, and had been working for more than two years with, Dawbarns, who were the solicitors in the MMR litigation, as an expert for them. That is despite the fact that he is responding to an allegation which he himself understood to be alleging litigation bias.

Secondly, he says that he “has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board”, but he makes no reference to the fact that they had funded his research to the tune of £25,000 at that stage, with more anticipated to come.

Dr Wakefield’s explanation for that, you will not be surprised to hear, is that he was responding to specific points only. It is our submission that it is a hallmark of his evidence that he falls back on this kind of terminological or grammatical analysis of allegations or questions which have been put to him in an attempt to obscure his own failure to respond openly and honestly and then he places the burden on others to pin him down and to ask for what he actually describes as “further and better particulars”. So he says that is what should be done if people want straightforward answers, in effect.

It is worth seeing how Mr. Wakefield’s colleagues thought of the Rouse letter. In summarizing the defense for Prof. Walker-Smith (one of the Wakefield team who was also sanctioned by the GMC), his attorney noted

(a) At the time that the Lancet children were investigated at the Royal Free, Professor Walker-Smith had no knowledge of Dr Wakefield’s dealings with the Legal Aid Board.

(b) Some time around the beginning of 1997, Professor Walker-Smith became aware that Dr Wakefield was acting as an expert on behalf of a number of children in a group action concerning MMR. Professor Walker-Smith did not want to have any involvement in actual or potential litigation.

(c) Professor Walker-Smith was not aware of the litigation status of the Lancet children at the time that the Lancet paper was written.

(d) It was not until the Rouse correspondence in the Lancet in 1998 that Professor Walker-Smith became aware that Dr Wakefield had agreed to “evaluate a small number of these children on behalf of the Legal Aid Board”. This was after the Lancet paper had been published.

(e) It was not until Mr Deer contacted him many years later that he was informed about a sum of money that had allegedly been paid to Dr Wakefield by the Legal Aid Board.

(f) It was not until 2004 that Professor Walker-Smith learned the number of Lancet children that were part of the “class action” in which Dr Wakefield was involved.

There is a lot in that statement of interest, but for this discussion I will focus on the statement that Mr. Wakefield did not disclose to his colleagues that some of the children he was working were involved with the Legal Aid Board. They learned about it from the Rouse letter. Why wasn’t Mr. Wakefield transparent even with his own colleagues?

Back to the Wakefield response, I think that it is a stretch to say that “no conflict of interest exists” or that the children came through formal channels. This ignores the fact that Mr. Wakefield played an active part in recruiting children into the study. This ignores the fact that Mr. Wakefield was aware that there indeed was a litigation bias involved in both himself and many of the study subjects.

As long as we are looking at the letters to the Lancet, here is one by Barbara Loe Fisher, of the self-named National Vaccine Information Center (in reference to a letter to the Lancet by members of the CDC):

“The pre-emptive strike by US vaccine policymakers on Andrew Wakefield and his colleagues’ investigation into the immunopathology of children with chronic enterocolitis and regressive developmental disorder brings into sharp relief the inappropriate intervention of politics into what should be an apolitical scientific examination.”

What is brought “into sharp relief” was that Mr. Wakefield’s study was not an “apolitical scientific examination”. Rather it was a litigation funded and driven project where crucial facts were hidden from the public. A true vaccine safety organization, which Ms. Fisher’s NVIC is not, would now be condemning Mr. Wakefield’s manipulation of the story. Instead, she gives him awards.

The Rouse letter shows that Mr. Wakefield failed in his duty to explain the details of his research to the public, and to his own colleagues. From where I sit, it also looks as though the Lancet failed to ask the direct questions that should have been raised at this point. They allowed Mr. Wakefield to avoid the sticky questions raised by the fact that Mr. Wakefield was involved in the MMR litigation.

Of course it is easy in hindsight to see the patterns. At the time, Mr. Wakefield was a highly respected researcher and much of what we now know was hidden. But it is very frustrating to think that the story could have been (should have been) exposed so quickly after the publication of the Lancet paper.

I’m reading through the transcripts from the General Medical Council Hearing on Andrew Wakefield and his colleagues at the Royal Free Hospital. It is long. Very long. Each day runs tens of pages (day 31 is 79 pages alone). Even beyond the bulk of the proceeding I find it difficult reading. I find it very difficult to read about the ethical lapses committed in the name of care of disabled children. Because of that, I quickly moved to a topic I have already written about and one that is less painful to discuss: the patent application Mr. Wakefield submitted on his “transfer factor”.

A thorough discussion of the patent history can be found on Brian Deer’s website. Brian Deer is the journalist who uncovered much of what the GMC was later to pronounce as ethical violations.

The patent is very clear in that it covers both the use of the transfer factor as a therapeutic agent and as a prophylaxis. In other words, Mr. Wakefield patented a treatment and a vaccine. Even though this is painfully clear, Mr. Wakefield has continually denied that the invention was a vaccine.

Day 31 of the hearing went into great detail about the patent. I was surprised to read (or had forgotten had I read before) that Mr. Wakefield applied for the patent without his hospital’s knowledge. This is very odd since the Royal Free was named as the applicant.

Below is a section from a memo, dated March 10, 1998 from Ruth Bishop to Cengiz Altan Tarhah, of University College, London (of which the Royal Free Hospital is a part).

Last summer, Andy Wakefield wrote to the School describing a patent application which he had personally filed along with Neuroimmuno Therapeutics Research Foundation (NIT). This was filed without the School’s knowledge, although in the name of the School. This application concerns the ‘transfer factor’ and Mr Wakefield asked if the School would be prepared to take on the prosecution and costs – he was (and is) meeting these himself.

Applying for a patent without approval from his institution is amazingly foolish. Aside from the obvious chutzpah, it basically invalidates the patent. For most people this would be a remarkable career mistake. While is is serious, it pales in comparison to the many other ethics violations that the GMC found Mr. Wakefield guilty of.

Let’s take a closer look at the question of whether it was Mr. Wakefield’s intent to use the invention, the “transfer factor”, as a vaccine. Mr. Wakefield submitted a business plan whereby he and the father of child 10 (the 10th child in the Lancet study) would develop the transfer factors.

In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.

Emphasis added.

Recally, Mr. Wakefield contended that the MMR was causing inflammatory bowel disease. He had plans to test his transfer factor to prevent IBD, not just to treat it.

It was a Vaccine.

Should that language be vague enough for some to still claim Mr. Wakefield didn’t intend on developing a vaccine. Here is a section from the “Strategy and Objectives” section of the business plan:

[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.

Emphasis added.

Again–a vaccine in addition to a therapy.

It was a vaccine.

A sub-heading of “Strategy and Objectives” reads: Establish the potential of the high specific active preparations as a potential measles vaccine. It just doesn’t get much clearer than that.

This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”

They planned to develop this with someone like Glaxo Wellcome’s Jenner Institute. That would be a vaccine research group (Jenner being the inventor of the first vaccine, for smallpox, in the 18th century).

Further, the business plan included objectives:

“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”

Emphasis added.

Vaccine replacements. Replacements. Not “we are using the name vaccine to mean a therapy”, but a replacement.

I know I’ve given the evidence a number of times in this post, but I just can’t understand why Mr. Wakefield even tries to deny his intent to develop a vaccine in the true sense of the word.

It was difficult to understand how people believed Mr. Wakefield’s story before. I will be amazed (but not surprised) that they continue to do so.

Just in case you missed it, here is one of the goals for Mr. Wakefield’s proposed company: “Establish the potential of the high specific active preparations as a potential measles vaccine”