With the defamation suit by Mr. Wakefield filed in Texas there is the strong possibility that the discussions will ensue again about what actually happened during Mr. Wakefield’s research at the Royal Free hospital. The one record of this is in the transcripts for the GMC hearings. These can be found online in a few places (casewatch and Sheldon 101’s blog Vaccines Work, for example). These are useful resources but somewhat cumbersome. Most people are not going to download a file to check a quote in context. And context can be very important, as we’ve seen here on Left Brain/ Right Brain where previous discussions by Mr. Wakefield’s supporters often involved pulling quotes out of context.
I don’t want to clutter this site with the transcripts, but I do want them in a place where internet search engines can find them and people can easily link and check quotes. So I am now uploading them to a new blog. It should take a few days to get the transcripts online in this format. About 30 days worth are up now.
In doing so I re-read some of the pages. One of the best examples of what happened is covered on Day 28. This is the day when the mother of Child 12 (last of the 12 children in the Lancet study) testified.
This one day’s testimony addresses many of the discussion topics which come up repeatedly in online discussions:
1) Parents of the Lancet Children were not prevented from testifying at the GMC.
2) She was the only one who did testify. She was the only one called by the GMC. The defense appears to have not called any of the parents.
3) Mr. Wakefield’s attorney declined the opportunity to even cross examine this parent.
4) The idea that Mr. Wakefield only reported what parents told him isn’t well supported by the evidence. Rather, there is a very circular route for the idea that the MMR causes autism. Mr. Wakefield and Mr. Barr (the attorney working on the litigation) were in contact with this parent multiple times before the child was seen at the Royal Free.
5) Some of the children in the Lancet study were registered with Legal Aid at the time of the study, and well before the Lancet paper was published.
6) The idea that the children were referred through normal channels is not accurate. While this child was referred through general practitioners, there was much contact between the mother, Mr. Wakefield and the attorney before that. One letter from the attorney makes it clear that they expressly told the parents to be sure to get the GP referral.
7) The idea that this work was not a research study isn’t really accurate. Mrs. 12 repeatedly gives her impression that they were involved in a research study.
Yes, this has all been covered before. Unfortunately, I fear this will all be covered repeatedly as this new case works its way through the court.
With that, here are some excerpts from the Day 28 testimony. Which you can check in context.
Q I think it is right that at around the same time, as well as that contact with Dr Wakefield, did you also have some contact with a firm of solicitors called Dawbarns?
A Yes, that is right.
Q Can you tell us how that came about. Why did you get in touch with them?
A The same mother told me about them as well.
Q What was your understanding of what they were doing?
A They were trying to really put a stop to the MMR vaccine being used and obviously to stop any damage that was being done to children.
Emphasis added. Mrs. 12 thought that Dawbarns “were trying to really put a stop to the MMR vaccine being used”.
After contacting the lawyers, she received a letter. This is dated 18 July 1996. Her son wasn’t seen at the Royal Free until 18 October, 1996, three months later:
“Dear [Mrs 12],
Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hunt Dickens of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the Government’s measles/rubella vaccination campaign in the autumn of 1994.
To give you an idea of our work I enclose an information pack which consists of a copy of a fact sheet which we have produced on the MMR vaccine and a fact sheet on ourselves.
We have built up a considerable volume of evidence that vaccines can cause injury to children, and we are hoping to take compensation claims to court. See the fact sheets for more information. Legal Aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects. In claims being brought on behalf of children the Legal Aid Office does not take into account the finances of the parents, but there are sometimes difficulties in obtaining legal aid …”
She was supplied with a “fact sheet” written by Mr. Wakefield. No contamination of the study there, right? In the Lancet he’s just reporting what the parents told him. No mention of the issue of the parents being supplied with a “fact sheet” to guide them.
Richard Barr (the attorney managing the litigation effort and teamed with Andrew Wakefield) wrote her on 14 August 1996
“We are also in touch with other experts and together they are hoping to establish a link between the vaccine, inflammatory bowel disease and autism. There is a clear cut biological mechanism for linking the two conditions. I suggest it might be worth your while to contact Dr Wakefield. If you would like me to do so I will be happy to make the introduction for you. May I have permission to send him a copy of the statement that I have prepared for [Child 12]?”
They are hoping to establish a link and “there is a clear cut biological mechanism for linking the two conditions [bowel disease and autism]”. Two months before being seen at the Royal Free she is informed about the effort to link MMR with autism and bowel disease and the idea that autism and bowel disease are linked.
Clearly any study reporting “what the parents told us” is contaminated at this point.
If you think the study could be salvaged, even with this level of contamination, here is a discussion of the fact sheet supplied to the parents as mentioned above:
Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,
“Inflammatory Bowel Disease, measles virus and measles vaccination.
What is inflammatory Bowel Disease (IBD)?
IBD comprises 2 conditions that have many similarities. Crohn’s disease and ulcerative colitis. Crohn’s disease may affect any part of the bowel, from mouth to anus, whereas ulcerative colitis affects the large bowel only. Many people now believe that these two conditions are part of a single spectrum of intestinal disease. IBD is often difficult to diagnose in children, especially Crohn’s disease, and this may lead to a delay in diagnosis with frustration for parents, doctors and, in particular, the affected children.
What is the link with measles and measles vaccine?
Measles virus was put forward as a possible cause of Crohn’s disease in 1989. The dramatic rise in the incidence of inflammatory bowel disease in developed countries over the last 30 years, in the face of live measles vaccination, also suggested a link between the vaccine and the disease.
Several groups from around the world have now identified measles virus in tissues affected by Crohn’s disease and an immune response to measles virus in the blood of patients with Crohn’s disease and ulcerative colitis. Early exposure to measles virus appears to be a major risk factor for developing Crohn’s disease later in life, and one study recently linked live measles vaccine to both Crohn’s disease and ulcerative colitis. Several new studies are currently underway that are designed to clarify the association between measles vaccination and inflammatory bowel disease. Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.
Then the fact sheet sets out what you would look for (and what you should do: contact Andrew Wakefield):
Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,
“Crohn’s disease. The symptoms and signs of Crohn’s disease in childhood are often insidious and non-specific and may lead to a delay in diagnosis. Intestinal symptoms include mouth ulcers, cramping abdominal pains, loss of appetite, diarrhoea with or without blood and problems in the anal region, including skin tags, tears or abscess formation. However, children commonly present with weight loss and failure to thrive as the only indications that they may have Crohn’s disease. But be aware, unexplained joint paints, sore eyes and skin rashes can also be the presenting symptoms of Crohn’s disease.
Ulcerative colitis is often more clear-cut, with diarrhoea, urgency and blood and mucus mixed in with the stools. Again, growth failure and symptoms such as joint pain may precede the intestinal problems.
What should we do?
If you suspect that your child has inflammatory bowel disease, prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”,
A document by Wakefield, possibly from the Royal Free says that there is a link between Crohn’s disease and the measles vaccine. This given to prospective study subjects before being seen at the Royal Free. But no contamination of the study subjects again, right?
Child 12 was registered with Legal Aid before in August, two months before being seen by the Royal Free:
Q Also enclosed with that letter of 14 August 1996 were the legal aid forms. I think that is right. Did you fill in the legal aid forms in order for an application to be made for your child to be legally aided?
A Yes.
One issue that Mr. Wakefield has brought up in recent years is the concern over vaccines containing the Urabe strain of mumps. Mr. Wakefield has gone into detail about how he was informed by a “whistleblower” about how the government handled the licensure of those vaccines. Mr. Wakefield had those discussions with the whistleblower in 1999 but appears to have done little with the information until the past few years. Why? Perhaps this comment by his colleague Richard Barr will shed some light onto this: “Although Immravax and Pluservix were withdrawn on safety grounds, the particular problem they caused was fairly limited. ” It was the opinion of Mr. Barr at the time that the Urabe strain mumps concerns with some of the MMR vaccines was “fairly limited”. Mr. Barr and Mr. Wakefield, of course, had a different avenue to pursue: the measles/gut disease/autism hypothesis.
In Sept. 1996, Barr sent Mrs. 12 a newsletter:
Under the heading, “Pilot study”,
“If we can prove a clear link between the vaccines and autism/inflammatory bowel disease this will be exceedingly useful, not only for cases involving those conditions, but also for other types of damage such as epilepsy.
To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free Hospital in London. We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests to be carried out by a number of leading experts in their fields. We will of course be liaising closely with the families concerned and the doctors will be giving very full details of what will be involved”.
Need I point it out again? Before even arriving at the Royal Free, Mrs. 12 was informed about the need to provide a clear link between vaccines and autism/bowel disease.
Q We have heard from the Dawbarns newsletter that I read to you previously that as far as the solicitors were concerned there was a pilot study being arranged. Did you have any understanding or awareness whether your little boy was a part of that pilot study at all?
A He was referred to Dr Wakefield by my GP for investigations, which I understood to be research investigations, but that was the route he was referred.
She felt that her child was being referred for “research investigations”
Mr. Wakefield is keen to tell everyone that the referrals came through the GP’s. He doesn’t mention that he and Mr. Barr made sure ahead of time that they went through the GP’s:
“Dear Mrs [12]
Many thanks for your letter of 10 September 1996. I will contact some other parents in your area and if they agree then you can all swap names and addresses. It is interesting how isolated people feel (and sometimes are!).
I would like to see the records. These may well be helpful if we have any difficulties over legal aid. At the moment I am still waiting to hear from them.”
So that was the end of the correspondence, and I now want to ask you about the actual referral, which you have explained to us was through your GP to the Royal Free Hospital in respect of your boy. We have been through this already, but just to remind you, if you go back to the GP records, please, page 126, this is a letter that I asked you about when I first began to question you, Mrs 12, the letter from Dr Wakefield, and we see in that the suggestion that you in fact you should go to your GP for a referral. Did you do that?
Emphasis added.
On admission to the Royal Free:
Q “Soils – not had diarrhoea. Has variable abdominal pain”, and then I cannot read the rest of that sentence. Mr Miller is trying to assist me – “occurring every week”. Thank you. “Mother had not associated vaccination with his problems until met a parents support group”. Does that set out the problem as far as his gastrointestinal symptoms were concerned, I mean obviously in brief terms?
A Yes.
“Mother had not associated vaccination with his problems until met a parents support group”. Earlier in the transcript it is noted that this parent group included the mother of Child 6 and 7 and this is where Mrs. 12 was put in touch with Mr. Barr and Mr. Wakefield.
After her son was seen at the Royal Free, here’s the letter Mrs. 12 wrote. Note that she read the proposed “clinical and scientific study notes”. But this was just a routine referral, right?
“Dear Professor Walker-Smith,
I am writing following [Child 12’s] visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also re-read Dr Wakefield’s proposed clinical and scientific study notes.
We do feel that [Child 12] does have a problem in that most children of his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose, which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.
Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [Child 12] is not growing or putting on weight like my other two children.
I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [Child 12] but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.
I do hope to hear from you in due course.”
In a letter to Mr. Wakefield she notes:
“Finally, I would like to say how nice it was to meet you at the JABS open meeting on 4 October in London. I found your short discourse both informative and interesting. I wish you all the best with your research.”
Yes, Wakefield was lecturing at JABS (an organization focused on vaccine injury) meetings. Mrs. 12 attended. This is Oct. 4, two weeks before her child was seen at the Royal Free.
Once again, we are in the merry-go-round. Mr. Wakefield only reported what the parents told him, except that here we have a clear example of a parent hearing from Mr. Wakefield on more than one occasion about what he was investigating.
The first visit to the Royal Free was not with Mr. Wakefield (Mr. Wakefield did not have clinical duties). Child 12 wasn’t even going to be referred to Mr. Wakefield at first:
Q So that was from your point of view, but you say in your letter to Dr Wakefield, Professor Walker-Smith’s main reasons for not referring [Child 12] on to Dr Wakefield was the absence of blood in the faeces and the lack of diarrhoea, you were saying that is what Professor Walker-Smith’s view was, is that correct?
A Yes.
But a blood test was “slightly abnormal” so they did make the referral.
“Dear [Mrs 12],
I do apologise for the delay in replying to your letter of 28 November. The slight abnormality that you referred to in your letter was that one of the markers of inflammation was just slightly above the normal range, it just means that we should go ahead. I understand that [Child 12] is coming in in the New Year to have a colonoscopy.”
A “slight abnormality” was enough to warrant a colonoscopy. Oddly enough, a later letter states that the blood tests were not abnormal.
The psychiatrist was not very clear on autism diagnosis:
Q If you to go page 18 in the medical records, we have a note dated 10 January, and in fact we have heard some evidence from Dr Berelowitz and he has given evidence in relation to all the children, including your son, and it was his evidence that this was his note, and we see at the bottom a diagnosis of “language delay ? [attention deficit disorder]” and then “? Asperger’s”: do you have any recollection of that?
The Royal Free didn’t think child 12 should have an MRI or a lumbar puncture.
Q If we go back to the Royal Free records – you can put FTP7 away, you will not need it again – at page 21 – it is on 6 January, so the day after the admission – at the bottom of the page it says, “[Ward round] Professor Walker-Smith” and it is a note signed by presumably a junior doctor, “colonoscopy” and then it gives, “prominent lymphoid follicles …” and “? some minor inflammatory changes” and then it says, “not to have MRI or L.P.” In other words, not to have an MRI scan and not to have a lumbar puncture. Then, Wednesday to have a barium meal. Were you aware at all of that note, Mrs 12? Were you aware at the time that that instruction had been given?
A No.
Emphasis added. But a colonoscopy and lumbar puncture were performed:
Q You say that you recall your son having a lumbar puncture and an MR scan; were you there for those?
A Yes.
Q You have obviously given consent for the MR but were you actually there when they were carried out?
A Yes.
Q Both of them?
A Yes.
Again, Mrs. 12 felt this was a research project:
Q You have told us that you thought that your son was part of a research investigation. Did you have any understanding as to which of those investigations, all of them or any of them, were part of the research investigations?
A As far as I understood, it was all part of the research into this possible link between the problems that [Child 12] had and the vaccine.
The tests apparently showed some immune activation
“Dear [Mr and Mrs 12],
I am writing to confirm the results from [Child 12]’s visit in the New Year. All were normal, including test for Fragile X, except the immune test. This shows evidence of persistent viral infection; i.e. [Child 12]’s immune system is activated in such a way that indicates it is trying to deal with some sort of ongoing viral infection. If you need to discuss these further please contact Dr Wakefield. I have passed on your query about gluten free diets to Dr Wakefield. I hope that [Child 12] is well and that his aching knees are settling”.
Then she gives some results at the bottom of the page. It shows,
“Full blood count and inflammatory markers – normal (i.e. no evidence of anaemia or inflammation”,
and various other negative tests.
Emphasis added. But above we read that the reason why Child 12 was referred for a colonoscopy was because a blood test indicated possible inflammation.
In June 1997, after the work at the Royal Free was finished, the attorney, Richard Barr, wrote to Mrs. 12:
“Thank you for your letters of 3 and 10 May 1997. I am sorry about the delay in coming back to you. I inevitably seem to be behind with my correspondence.
I haven’t heard anything more from the Vaccine damage Tribunal”.
Then he says,
“I haven’t had a copy of the Meridian TV item”,
so obviously you had made some reference to it, because he says,
“I would be very interested to see a copy if you can organise it some time.
We are all waiting for Andy Wakefield to deliver the goods and I really think that if he can provide the proof he thinks he can it is going to be much easier to win the cases.
I am interested in your comments about the rise in the incidence of mumps. What you say, of course, is absolutely correct.
I don’t think you have been updated on our fact sheet recently and in case it is of interest I enclose a further updated version. You will see that once again the section on autism has been extended. Don’t be deceived by the fact that it may not look quite as long as before. We have reduced the print size”.
Emphasis added.
After an extensive examination by the GMC’s attorneys, the defense was given an opportunity to cross exam:
THE CHAIRMAN: Mrs 12, as I indicated earlier, this is now the opportunity for representative counsel of the three doctors to cross-question you if they feel it appropriate. Are you happy to continue?
A Yes, that is fine.
THE CHAIRMAN: At any stage if you think that you need a little break, just give me a little hint and I am sure that the Panel will be quite sympathetic. Mr Coonan.
MR COONAN: Sir, I have no questions, thank you.
Mr. Coonan would be Mr. Wakefield’s attorney. He declined the opportunity to examine the one parent from the Lancet 12 who appeared at the GMC.
Mrs 12 was cross examined by Mr. Miller, attorney for Professor Walker-Smith.
Even as a summary this is long. But at least now people can easily check quotes in context.
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