Left Brain Right Brain

As Kev recently wrote here on LeftBrainRightBrain, the main defense of Andrew Wakefield is not a defense at all, but an attack on Brian Deer. Rather than look at the facts laid out in the BMJ article, people are claiming that Andrew Wakefield couldn’t possibly have “fixed” the data (lead authors can and have do this, see our recent post). Also, that Andrew Wakefield didn’t have access to the full records of the children, so that he couldn’t have known that there were contradictory data in those records.

It is an odd argument in that it concedes that yes, indeed, the “facts” in the Lancet article do not match the children’s medical records.

It is also an odd argument because it ignores the citations that Brian Deer makes in his article. Mr. Deer cites where he gets the information that contradicts Andrew Wakefield’s reports. Many of which are not hidden in the child’s records but were available to Mr. Wakefield at the time he wrote his article for the Lancet.

Mr. Wakefield has reported in his Lancet article (now retracted) that “We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers. ”

Emphasis added.

As Brian Deer has noted in his article in the BMJ, this is not the case. Many of the children reported upon were not “previously normal”. We here at LeftBrainRightBrain have the luxury of more space than did Mr. Deer, so let’s check a few of Mr. Deer’s statements, shall we? Let’s look at the children that Mr. Deer commented upon in his article.

Early on in his article, Mr. Deer refers to Child 8. Child 8 was noted as having facial dysmorphisms. Further, the doctors treating Child 8 “…had significant concerns about her development some months before she had her MMR Vaccination”.

Here is a letter sent to Andrew Wakefield on 3 October, 1996. The Lancet article wasn’t published until 1998:

“ Dear Dr Wakefield

[Child 8’s] mother has been into see me and said that you need a referral letter from me in order to accept Child 8 into your investigation programme. I gather this is a specific area of expertise relating to the possible effects of vaccine damage and her ongoing GI Tract symptoms. As far as I am concerned, if [Mrs 8] is happy to proceed with this and it gives her any further information and peace of mind, I am sure it would be beneficial for both her and for [Child 8]. I enclose photocopies of some recent correspondence which gives a fair idea of [Child 8’s] current state. I would simply reiterate Dr Houlsby’s recent comment that both the hospital and members of the Primary Care Team involved with [Child 8] had significant concerns about her development some months before she had her MMR Vaccination. I take Mum’s point that she has video evidence of [Child 8] saying a few words prior to this vaccination being given and her vocal abilities are now nil but I do not think we can be entirely convinced as yet that the vaccine is the central cause of her current difficulties. However, I am quite prepared to support [Mrs 8] in her quest for further information and I hope some useful results come from these tests.

Best wishes.”

emphasis added.

This was presented to the GMC on Day 29 of the hearing. Mr. Wakefield knew Child 8’s physicians questioned whether child 8 was “previously normal” when he wrote the article in the Lancet. It is unclear if Mr. Wakefield sought out those physicians, or if the “recent correspondence” also noted those early signs. But we do know that Andrew Wakefield had more than just the parent’s report on the child’s history and that the physicians disagreed with the parent’s impression. Given the contradiction between the two sources, at the very least, Mr. Wakefield should have sought out the child’s records.

As an aside here, Child 8 was already funded by legal aid at the time of referral. Mr. Wakefield has claimed that children were not already a part of litigation when they were seen by him at the Royal Free. This is also noted in an doctor’s note in the transcripts:

“Mum taking her to Dr Wakefield, Royal Free hospital for CT scan and gut biopsies.
? Crohn’s – will need a letter.
Dr Wakefield to phone me.
Funded through legal aid.”

Again, the child was “funded through legal aide” before referral to Mr. Wakefield.

Here is how Child 4 is reported in The Lancet paper:

One child (child four) had received monovalent measles vaccine at 15 months, after which his development slowed (confirmed by professional assessors). No association was made with the vaccine at this time. He received a dose of measles, mumps, and rubella vaccine at age 4·5 years, the day after which his mother described a striking deterioration in his behaviour that she did link with the immunisation.

“Confirmed by professional assessors”. I find this interesting. One of the defenses of Mr. Wakefield is that “he was just reporting what parents told him”. But, there it is, “confirmed by professional assessors”. Andrew Wakfield had “professional assessors” check the validity of the claims. Have Andrew Wakefield’s supporters actually read the paper?

Was there anything in this child’s records that a “professional assessor” might flag as possibly showing signs of delay before vaccination? Here is the letter from Child 4’s doctor to Mr. Wakefield dated 1 July 1996.

“Following our recent telephone conversation I would be grateful if you could arrange an appropriate ECR appointment for [4] to undergo assessment regarding his possible autism and his bowel problems.

[Child 4] has had long standing difficulties and shows severe learning difficulties and also bowel disturbance and his mother has always found it difficult to accept that there was no known cause for [Child 4]’s disorder. A few years ago she was chasing the idea that he might have a metabolic disorder and I enclose a copy of a letter I wrote to Dr Wraith in Manchester at that time although his reply was he did not see any value in further tests along these lines. I’m aware that you are looking at the possible links between measles vaccine and various difficulties and [Child 4] certainly had MMR in 1988. In general [Child 4]’s mother thinks that he developed normally initially and then subsequently his problems worsened and he lost some of the milestones he had achieved but that he has subsequently improved on something of a restrictive exclusion diet. The professionals who have known [Child 4] since birth do not entirely agree with this however and there is a suggestion that some of [Child 4]’s problems may have started before vaccination.

Since 1994 4 has continued to have intermittent problems with his bowels and diarrhoea that [Mrs 4] relates to food intake; he has had a negative test for celiac disease and has on at least 2 occasions had giardia but he has had no further investigations regarding the cause of these symptoms.

As I say, [Mrs 4] is convinced that both [Child 4]’s behaviour and his diarrhoea are triggered by his diet and she has him on something of a restrictive exclusion diet. He has not gained weight and we have been very concerned about this and [Mrs 4] feels that this is despite him being on a more normal diet. We have therefore not made any assessment as to whether his failure to gain weight might be due to an inadequate diet or to possible malabsorption.

I would be grateful if you could arrange an appropriate appointment and would be very interested if you feel [Child 4] fits into the sort of category of patient that you are interested in looking at further”.

From Day 6 of the GMC hearing. Note that the “…had MMR in 1988” is likely incorrect and that it was the monovalent measles vaccine in 1988.

Again, Mr. Wakefield was alerted to a child having possible problems before MMR administration, but reported the child as “previously normal”. We are left with a question, did Mr. Wakefield just fail to follow up on this possibility or did he know the details and misreport them?

Here is a statement in the child’s records. Whether this was available to Mr. Wakefield at the time of writing the article in The Lancet is unclear:

A delayed development was acknowledged by the health visitor at 1 year of age but at this stage [Mrs 4] did not accept that [Child 4] was slow.

Here is a letter written to Child 4’s physician after his time with the Royal Free team:

“I will write to Dr Wakefield to see if I have any better luck at getting a summary of their investigations and conclusions. [Child 4] had a course of (I think) sulphasalazine after his investigation at the Royal Free Hospital. He became acutely distressed, apparently with abdominal pain and his autism and behaviour did not improve. It was therefore discontinued after a fortnight”.

Apparently, the therapies Mr. Wakefield’s team supplied were not always beneficial.

Let’s move on to Child 1. Mr. Deer reports in the BMJ:

The remaining five children served Wakefield’s claims no better. There was still no convincing MMR syndrome. Child 1, aged 3 years when he was referred to London, lived 100 miles from the Royal Free, and had an older brother who was diagnosed as autistic.76 Child 1’s recorded story began when he was aged 9 months, with a “new patient” note by general practitioner Andrea Barrow. One of the mother’s concerns was that he could not hear properly—which might sound like a hallmark presentation of classical autism, the emergence of which is often insidious. Indeed, a Royal Free history, by neurologist and coauthor Peter Harvey, noted “normal milestones” until “18 months or so.”

Child 1 was vaccinated at 12 months of age, however. Thus neither 9 nor 18 months helped Wakefield’s case. But in the Lancet, the “first behavioural symptom” was reported “1 week” after the injection, holding the evidence for the lawsuit on track.

Here’s the “new patient” note:

“New patient – recently posted from XXXX. Mum worried re hearing/wax in ears/? Discharge left ear … Reassured.” Then “(NB – older brother … ? behaviour probs and ? family dynamics ?)”.

Here’s the statement by Dr. Harvey (of the Royal Free): “after normal milestones a deterioration from 18 months or so”. The referral letter for this child, sent to the Royal Free, states that the child was normal until age 15 months.

Here is a statement from the records at the Royal Free (day 24 of the transcripts):

“Child 1 was admitted for further investigation of his autism and specifically to look into a possible association between his neurological condition and any gastrointestinal disorders. The main problems are a “classical” autism diagnosed a year ago and of diarrhoea.”

On page 50:

“His diarrhoea started approximately 18 months ago. He passes five watery stools a day which contain no blood or mucous. They do contain some undigested food. He appears to have no control over his bowel movements and frequency is increasing. His appetite has always been poor and there has been no obvious change in this. He has only very occasional episodes of vomiting.

He is up-to-date with his immunisations, including his MMR at 12 months of age. There is obvious parental concern that this has some bearing on his subsequent condition.”

Perhaps not consistent, but Andrew Wakefield knew that the child’s records did not place concern until much time had passed since the MMR vaccination.

The “onset of behavioral symptoms” reported in The Lancet does derive from parental report. But not a very strong report. A letter to Andrew Wakefield about child 1 put it like this:

“I saw this interesting child with autism which began some weeks following MMR although there was 7-10 days after the MMR at the age of 1 a brief illness during which he was pale, possibly had fever and his mother said he may have been delirious. [Mrs 1] was keen that you would have a look at a document that she got concerning homeopathic remedies and I am passing this on to you.”

So, Mr. Wakefield reported Child 1 as having first symptom 1 week after MMR. If you include “fever/delirium”. Not exactly an autism symptom. But developmentally the child was noted as being normal until 15 or 18 months? Is that “fixing” data or just something less than accurate?

The Wakefield 1998 Lancet article did not give an accurate picture of these children, based on the records available to Mr. Wakefield at the time. And that is the important fact: Mr. Wakefield had access to information that put his reported findings into question.