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Andrew Wakefield’s many statements that MMR causes autism

8 May

One of the themes that has grown in the past couple of years that Andrew Wakefield never said MMR causes autism. Rather, the story goes, he was a cautious researcher who merely reported what parents told him and called for more research to be done.

Here is an example by Mr. Dan Olmsted of the Age of Autism blog:

That Early Report – which appeared in 1998 in the Lancet, Britain’s other leading medical journal – noted that in eight of the 12 children (including Thomas’s), parents linked the onset of symptoms to the MMR shot, and it called for more research to see if a link in fact existed. It said no link to the MMR was established by the simple case series report.

Despite that cautious approach, the report and its aftermath sparked a firestorm that, fueled by Deer, ultimately led to Wakefield losing his medical license and to the Lancet retracting the report. Yet thousands of parents continue to support Wakefield and describe the same sequence of shot and symptoms as parents in the original case series. Mainstream media, medical groups, public health officials and pharmaceutical companies say any link has been discredited.

For those who have actually followed the Wakefield/MMR story, the idea that Mr. Wakefield’s approach could be described as “cautious” is difficult to swallow. The idea that the “firestorm” was fueled by Mr. Deer is an odd assertion at the best. Mr. Wakefield’s now-retracted Lancet paper was published coincident with an anything-but-cautious press conference in February 1998. Mr. Deer started reporting in the story in February of 2004. But this is off topic. Mr. Wakefield is repeatedly cited as merely calling “for more research to see if a link existed”.

Mr. Olmsted is not the only one to use the “only called for more research” theme. Dr. Bob Sears, for example, stated:

1. Dr. Wakefield’s study never claimed there was a link between the MMR and autism – it only suggested a possible correlation between the MMR vaccine triggering intestinal inflammation which seems to occur in some children with autism. He basically called for MORE research to be done on this.

To be fair, the “only called for more research” theme goes back quite a way. Here is a news story from 2003.

The problem for Mr. Wakefield’s supporters is that Mr. Wakefield did not limit his discussion to the Lancet. As already noted, he held a press conference to announce his results and has made many more statements over the years. More to the point, Mr. Wakefield *did* say that the MMR causes autism.

Here is a collection of Mr. Wakefield’s statements which range from suggesting a possibility that the MMR causes autism to outright claiming that he “has shown” that the use of the MMR vaccine causes autism.

Mr. Wakefield’s patent application states clearly and unequivocally that the MMR vaccines has “been shown” to cause “pervasive developmental disorder”:

“It has now also been shown that use of the MMR vaccine (which is taken to include live attentuated measles vaccine virus, measles virus, mumps vaccine virus and rubella vaccine virus, and wild strains of the aforementioned viruses) results in ileal lymphoid nodular hyperplasia, chronic colitis and pervasive developmental disorder including autism (RBD), in some infants.”

And also

I have also found that regressive behavioral disorder (RBD) in children is associated with measles, mumps and rubella vaccination.

More examples include:

In the 1998 Lancet paper (now retracted), the MMR is referred to as one of the “the apparent precipitating events”

In sworn testimony in a congressional hearing Mr. Wakefield states that an “environmental insult” (previously discussed at length as vaccination) “in many children, clearly, the subset of autistics, it leads to gut infection and damage…”

So finally, in summary, we have an environmental insult in perhaps a genetically susceptible child. The problem is that if you go to Sweden now, autism affects over 1.2 percent of the pediatric population. So if there is a genetic background, it is clearly widely distributed within the population. We believe that in many children, clearly, the subset of autistics, it leads to gut infection and damage; that leads to an ingress, an impaired metabolism, degradation of these chemicals from the gut which then get through and impact upon the brain.

In the video for the press conference for his (now retracted) 1998 Lancet paper, Mr. Wakefield stated that the single (monovalent) vaccines are “safer than the polyvalent”. How can they be safer if there isn’t a proven link to autism?

My opinion, again, is that the monovalent, the single vaccines, measles, mumps and rubella, are likely in this context to be safer than the polyvalent vaccine.

and his feeling is that “the risk of this particular syndrome developing is related to the combined vaccine…”:

Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.

From the Power of One Idea” rally, Washington DC, April 21, 2002. Mr. Wakefield informs the public that public health officials have failed and “Among the reasons for this failure is the fact that they are faced with the prospect that they themselves may be responsible for the epidemic”:

We are in the midst of an international epidemic. Those responsible for investigating and dealing with this epidemic have failed. Among the reasons for this failure is the fact that they are faced with the prospect that they themselves may be responsible for the epidemic.

Therefore, in their efforts to exonerate themselves they are an impediment to progress. I believe that public health officials know there is a problem; they are, however, willing to deny the problem and accept the loss of an unknown number of children on the basis that the success of public health policy – mandatory vaccination – by necessity involves sacrifice.

Neither I, nor my colleagues subscribe to the belief that any child is expendable. History has encountered and dealt with such beliefs.

You, the parent’s and children, are the source of the inspiration and strength for our endeavours; our quest for truth through science – a science that is compassionate, uncompromising and uncompromised.

I do not mean to stir you to mutiny, but be assured that armed with this science it is in your power to force this issue, in your pediatricians office, in Congress, in the Law Courts.

Keep faith with your instincts. They have served you well.

From a news story (Shame on officials who say MMR is safe) in 2001, Mr. Wakefield is quoted discussing how there are “long-term adverse reactions that I believe we are now seeing”.

Our new paper is not anti-vaccine. It is about the safest way in which to deliver these vaccines to children in order to protect them against acute infectious disease and against the long-term adverse reactions that I believe we are now seeing

From a BBC news program in 2002. The regression following MMR is referred to as “not a coincidence”:

WAKEFIELD: .. these children received not one dose but three doses of the MMR vaccine, and what we see in many of these children is a double hit phenomenon. They regress after the first dose and then they regress further after the second dose. This child did not receive his first MMR vaccine until he was 4 years 3 months of age. He then deteriorated into autism, a disintegrative disorder. He then received his second dose at 9 years of age and disintegrated catastrophically. He became incontinent of faeces and urine and he lost all his residual skills. This is not coincidence.

This is not to be considered an exhaustive list. I won’t be surprised if more quotes from Mr. Wakefield are in the media. But these should suffice: Mr. Wakefield has, repeatedly, stated that MMR causes autism.

Financials for Andrew Wakefield’s Strategic Autism Initiative

15 Mar

Non profit organizations in the United States have to file tax forms and those become part of the public record. After leaving Thoughtful House, Andrew Wakefield formed a non-profit called the “Strategic Autism Initiative” (SAI). That was in 2010. The tax forms (form 990) don’t become public right away, so the form for 2010 has been only recently made available, and is available here.

Since the SAI was formed in 2010, we don’t know how much of the year they were paying salaries (for example).

They pulled in $226,000. We know $100k was from Generation Rescue from their form 990.

Wakefield was paid $16,667. But we don’t know for how many months. SAI was formed in 2010, so it is a partial salary. He claims 30 hours/week.

Assume the $16,667 is one month’s salary. That works out to $200k/year at 30 hr/week. That’s the equivalent of nearly $270k for a full-time (40 hour per week) which was his salary at TH before he was let go.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota. They spent about $30k on this project, which is supposed to include prevalence studies in Somalia.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota working on this. They spent about $30k in each location on this project, which is supposed to include prevalence studies in Somalia.

As to the people involved with the SAI:

Andrew Wakefield is president
James Moody is VP
Terri Arranga is secretary
Mark Blaxill is treasurer
Polly Tommy is director
Phil Rawlins is director

Only Wakefield and Arranga are paid (Arranga was paid $2,400 in 2010, listed as putting in 15 hours/week)

They spent $5K in legal fees. $25k in advertising.

It will be interesting to read the 2011 form 990 when that is available. For one thing, this will give salary information for a full year. Also to see how well they do collecting donations. $250k is impressive for a first year. As already noted, $100k is from Generation Rescue. How much of the rest is really just a transfer from other vaccines-caused-an-autism-epidemic orgs is unknown.

What letter, Mr. Olmsted? Why this one, of course.

14 Mar

When Brian Deer wrote one of his 2009 article for the Sunday Times: Focus: Hidden records show MMR truth, he introduced the article with a discussion of the father of Child 11, the only American child in the Lancet 12:

ON a Monday morning in February 1997, a taxi left the Royal Free hospital, in Hampstead , northwest London. It turned out of the car park and headed to the renowned Institute of Cancer Research, six miles southwest in Fulham.

In the back of the cab sat a California businessman, whose commercial interests lay in electroplating, but whose personal crusade was autism. On his lap was a plastic pot, in which snips of human tissue floated in protective formalin.

The snips were biopsies taken from the gut of the man’s five-year-old son, then a patient on the hospital’s Malcolm ward. The boy, Child Eleven, as he is known to protect his privacy, had been enrolled in a programme to investigate alleged risks of the three-in-one measles, mumps and rubella (MMR) vaccine.

Mr. 11, as he is known, was the one parent who chose to confirm the results he was given by Mr. Wakefield’s team at the Royal Free. In particular, he wanted to confirm whether the tissue samples taken from his son really contained measles virus, as he was told. After taking samples to people outside Mr. Wakefield’s team at the Royal Free:

“It took a big fight to get the information,” said Mr Eleven. “They told me there was no measles virus. I had the tests repeated three times at different labs in the US, and they all came back negative.”

This comes as no surprise to readers today. Mr. Wakefield’s graduate student, Nicholas Chadwick, was telling him all along that the virology results were negative.

In a later report, How the case against the MMR vaccine was fixed, Mr. Deer also introduced the article with Mr. 11. He noted that Child 11 was listed in the Lancet article as having a first behavioral symptom of “Recurrent “viral pneumonia” for 8 weeks following MMR” as occurring 1 week after the administration of the MMR vaccine, a point critical to Mr. Wakefield’s claims. However, according to documents available to Mr. Wakefield, the child showed signs before the MMR. Per Mr. Deer:

But child 11’s case must have proved a disappointment. Records show his behavioural symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13-18 months he developed slow speech patterns and repetitive hand movements. Over this period his parents remarked on his slow gradual deterioration.”

Enter Dan Olmsted, proprietor of the Age of Autism blog. Mr. Olmsted sought out Child 11’s father to corroborate Mr. Deer’s story. Such is the importance of contradicting Mr. Deer that he was willing to contradict Mr. Wakefield’s claim in the Lancet as well. Mr. Olmsted claims that Mr. 11 wrote him that rather than 13 months, “The onset of his autistic-like behaviors began around 18 months.”

The one thing that Dan Olmsted, Brian Deer and Mr. 11 apparently agree upon: the report in The Lancet is incorrect. Somehow I expect there is some convoluted explanation Mr. Olmsted would offer to avoid this problem, but lets move on. Unfortunately to a rather odd back-and-forth where neither party (Deer and Olmsted) communicating directly. To start, Mr. Olmsted would have us believe that Mr. 11 is annoyed? angry? with Mr. Deer’s reporting and thinks they “misrepresented the facts”.

Mr. Olmsted wrote:
[edit to add: Mr. Olmsted is quoting Andrew Wakefield’s defamation complaint here. I.e. these are Andrew Wakefield’s words]

Indeed, the child’s father has since written Deer and the BMJ to explain that Deer was misrepresenting facts about child 11, yet Deer and BMJ have printed no retraction, correction, or mention of this fact.

Mr. Deer noted this claim by Mr. Olmsted in his declaration:

Neither I nor (to my knowledge) the BMJ have received any letter from this father accusing me of “misrepresenting facts.” Nor have we received any request from this father asking for any retraction, correction, or for us to take any action at all. On the contrary, the father confirms the terms of the medical record (which he gave me at a meeting in California in September 2007), but disagrees with the accuracy of that record. The matter is thus purely a (very common) situation where parental recall and medical records do not coincide, and naturally parents believe their recollection to be right.

In a recent article, Mr. Olmsted wrote:

But the father told me: “Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration,” a clear contradiction that called for a prompt correction.

See what Mr. Olmsted did there? He cut short Mr. 11’s sentence and added his own ending. Which made me wonder, what was the full sentence and what was the full context.

If you are wondering that too, here is the full sentence from that email, in context:

Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication.

Is that an accusation of “misrepresenting facts” by Mr. Deer, as Mr. Olmsted asserts? Rather than call for a retraction or correction, as Mr. Olmsted claimed, Mr. 11 noted that “The Lancet article is a clear misrepresentation of my son’s history”, and that “the Lancet article is simply an outright fabrication.”

How do I know what is in the full email? Brian Deer entered it (redacted, of course) into the public record as an exhibit to his declaration. Given the way Mr. Olmsted was clearly cherry picking the email, I wanted to obtain the source for myself.

With apologies in advance for any transcription errors. But mostly with apologies to the young man who was Child 11 and to his father:

Daniel Olmstead
Brian Deer
Dear Mr. Olrnstead & Mr. Deer:
I have spoken with both of you regarding my son who may be one of the subjects in the Royal Free Hospital’s “research study” on autism summarized in the 1998 Lancet article.

The main reason I am contacting you now is to reiterate to Mr. Olmstead that we wish for our family to stay out of the public eye, and request that in any further discussions of this matter our privacy and the confidentiality of our son’s medical history be respected. We appreciate that in published work you, Mr. Deer, did that. My son has not consented to any disclosures regarding his medical history, and I hope that whatever information you disseminate will be shared in a manner that is not personally identifiable.

My second purpose in contacting both of you is to clear up some confusion, albeit generating additional questions which, as I explain below, I do not think are worth pursuing. Mr. Olmstead informed me that he believes that my son is Patient 1 I in the Lancet article, a conclusion he seems to have reached due to a violation of doctor patient confidentiality by Dr F. Given Dr. F’s distance, so far as I know, from these events, and his current state, it is hard to know what to make of this purported information. Mr. Deer’s article appears to assume that my son is Patient 11 as well, describing conversations with a father of “Patient 11 ” that appears to be me. However, we have no confirmation that Patient 11 is my son. When we got information during the Royal Free’s investigation, we were told he was Patient 13. Only 12 patients are reported in the Lancet article. I have no way of knowing how many subjects were excluded from the final report, or whether my son was one of them.

In any event, the description of Patient 11 in the Lancet article is not accurate if, in fact, it refers to my son. The Lancet article indicates that autistic symptoms started at 15 months, a week after the MMR, which is completely inaccurate; my son’s autistic behaviors started 2-1/2 to 3 months after the MMR, which was administered to him at 15 months. The Lancet article is a clear misrepresentation of my son’s history. Moreover, the Lancet article is not consistent with the Royal Free’s discharge summary regarding my son, and both the article and the discharge summary are inaccurate. One of the incorrect statements in my son’s discharge report was that autistic symptoms were seen from 13-18 months, while the vaccination was at 15 months. This is clearly inaccurate as his symptoms began several months after the MMR, as reflected in my initial correspondence to the Royal Free requesting my son be included in the research study. Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s
article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication. My son’s autistic behaviors did NOT begin a week after administration of the vaccine, in fact they began several months afterwards, with several medical complications occurring in between.

The bottom line is that, if my son is indeed Patient 11, then the Lancet article made a false assertion that his symptoms set in immediately after the MMR; in service of some attorneys’ efforts to prove “causation” that, unbeknownst to me, apparently drove this research. If the sloppy mishandling of patient information and inaccuracies in my own son’s records is any indication of how that research was done, then I am very thankful that the Lancet article has been withdrawn and the “research study” discredited. That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases. I have been involved in and have supported serious research into the causes of and effective treatments for this illness. We know now that the study reported in the Lancet article was a huge and very costly distraction. I hope that you will join me in looking, with an open mind, at real explanations of the current situation, as well as in advocating for adequate medical care and educational services for the many people affected, so that outcomes can be positive, as they are now proving for my son. While some autism may be a natural part of the human condition, what is happening now requires explanation. We will not get it if we spend time rehashing old debates.

As for the confidentiality issues, I appreciate and rely on your courtesy and discretion

Mr. 11 asked for courtesy and discretion on confidentiality issues. I would put to Mr. Olmsted that when he published the first name of Child 11, he may not have been heeding Mr. 11’s wishes.

The father has made a few more statements about these events:

First, about the Age of Autism series: “Olmsted’s logic is twisted and emotional”.

About the research at the Royal Free: “We all make daily human errors, but I guess some people ( Royal Free ) do it for a lifetime !”

and

“What a HUGE embarrassment, and scientific fiasco ! “.

Mr. 11 asked “That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases”

Whether one agrees with the “epidemic” or not, the idea of moving on from the “debacle” (which I read in context to refer to the story about Mr. Wakefield and the Lancet study) and focusing on research is a very wise suggestion. As Mr. Olmsted has shown, not only has Mr. Wakefield been a huge distraction, but his supporters have been as well.

A few details from Brian Deer’s declaration

13 Mar

Brian Deer’s declaration in the anti-SLAPP motion presents an interesting narrative of the history of the investigation into Andrew Wakefield’s MMR project. Of course much of it is not new for those who have followed the story, There’s the initial investigation for the Sunday Times. There’s the interaction with Richard Horton at The Lancet. There’s the slow unveiling of the “trickle truth” from Andrew Wakefield as he is faced with fact after inconvenient fact uncovered about his actions. There is Mr. Deer stating firmly and clearly that he is not in the pay of pharma interests. But there are also some points I don’t recall being made public.

Brian Deer got pulled in to the MMR story by the attention being drawn to a 2003 TV movie in the UK: “Hear the Silence“. This was a docu-drama about Andrew Wakefield. Sort of a small point in itself, but Mr. Deer also shared this detail:

For example, I interviewed John Walker-Smith, former professor of paediatric gastroenterology at the Royal Free, and the senior clinical author of the Lancet paper. Among other things, he told me that the TV docu-drama had been paid for by an American family involved in the research.

I don’t recall ever hearing or reading that “Hear the Silence” was financially backed by a family involved in the research.

As an aside, in reading up on “hear the silence” I found this news article which included this letter from a co-author of the 1998 Lancet paper:

Wakefield was not treated as a pariah by the hospital and the medical school. Indeed, it is interesting that the research team received lots of offers from distinguished researchers, who were willing to assist in the further development of the project along solid scientific lines. Although many members of the team welcomed those approaches, Dr Wakefield did not. Indeed he became increasingly insistent on meeting only those who were clearly ‘of the faith’. By so doing he made himself a pariah, since no self-respecting scientist would want to dispense with scientific rigour and objectivity.

That was in 2003. Just as Brian Deer was starting on the MMR project.

Back to Mr. Deer’s declaration. Another point I found interesting involves Mr. Wakefield’s credentials. Inflated credentials have been found all too often amongst those who promote the idea that vaccines cause autism. Consider Mr. Wakefield, now, as an example. In the past, Andrew Wakefield used his credentials: Dr Andrew Wakefield, MB, BS, FRCS, FRCPath.

MB, BS is for his degree: Bachelor of Medicine, Bachelor of Surgery.

FCRS stands for “Fellow of the Royal College of Surgeons”

FRCPath stands for “Fellow of the Royal College of Pathologists“.

When Mr. Wakefield filed his defamation case against the BMJ, Brian Deer and Fiona Godlee, he had already dropped the FRCPath. According to Mr. Deer’s declaration, Mr. Wakefield had been “expelled from the Royal College of Pathologists” in 2010.

This begs the question why the Royal College of Surgeons did not expel Mr Wakefield. Mr. Deer clarifies that: “the college has informed me that he was not in fact affiliated with the Royal College of Surgeons at any time in the last 15 years. Therefore, he
could not be expelled.”

Yes, Mr. Wakefield has apparently been using FRCS after his name without having the right to do so for 15 years. This includes in the documents he filed in the Texas courts for the defamation case.

What can one say: the top of page one of his petition includes an affiliation Mr. Wakefield apparently has no right to use. Perhaps a small point which will come as part of the many unwelcome surprises for his attorney.

Another odd fact was that Mr. Wakefield used a publicist as far back as 2003, when Mr. Deer first approached him. By Mr. Deer’s account, Mr. Wakefield is the only doctor he’s encountered with a publicist. Mr. Deer asked numerous times for interviews, but Mr. Wakefield has always declined. In one case, Mr. Wakefield allowed the Sunday Times to interview him, but only if Mr. Deer, the man doing the story, was not present.

Perhaps Mr. Deer has stated this somewhere, but he was attending the GMC hearings as a representative of Channel 4 (where he had done a documentary on Mr. Wakefield years earlier).

It is interesting to see just how many times Andrew Wakefield has sued or threatened suit against journalists.

Here is a quote from Mr. Wakefield’s business plan. This was drafted before the Lancet article was published and only obtained via a freedom of information act request. (Note that before the FOIA was enacted in the UK Mr. Wakefield’s hospital stonewalled attempts to obtain such documents). This isn’t really new information (it came out in the GMC hearing), but does have impact on the defamation claim:

It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA. It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.

It is very hard to argue that claims that Mr. Wakefield had clear financial conflicts of interest in light of such documents. Or that he had interests above and beyond his part as a paid expert in keeping the MMR litigation going. Or that these conflicts were hidden from the public, as they only came to light through FOIA long after the Lancet paper was published.

Here is an example of the defamation Mr. Wakefield alleges stems from comments by Fiona Godlee:

For example, in an additional allegation of fraud against Dr. Wakefield, Dr. Godlee referred, in her lecture, to a comparison of the interval between MMR vaccine exposure and “symptoms” in children reported by Dr. Wakefield and his colleagues in two different versions of the Lancet Article, a draft prepared in August 1997 and the final published paper, the Lancet Paper. Dr. Godlee went on to use this allegation as her basis to conclude that Dr. Wakefield fraudulently manipulated the reduction of the time interval in order to create “a legally compelling case which would be a maximum of 14 days and in this case an average of 6.3 days.” She not only falsely suggested that Dr. Wakefield fraudulently misreported this medical data, but she imputed to him a malignant intent that he knowingly altered this data in an effort to influence vaccine injury litigation. Both allegations are false and defamatory.

A key finding of the Lancet article was that 8 of 12 families blamed the MMR as the “apparent precipitating event” in causing their child’s autism. The time between MMR and onset of symptoms was 14 days. However, Mr. Deer has pointed out that more than the 8 reported families blamed the MMR. When those children were removed from the pool, the average time from MMR to onset of autism symptoms narrowed considerably (a point Mr. Deer has made repeatedly). What I hadn’t absorbed before was that Mr. Wakefield had admitted at one point that some of the parents’ recollections were omitted from his claim. From Mr. Wakefield’s press complaints commission submission:

Parents of 8 of the 12 children made the link between MMR vaccination and onset of symptoms contemporaneously. Other parents made the link retrospectively, that is, some years later. We reported on those 8 who made the link at the time of their child’s deterioration and excluded those who made the link later in order to remove any bias associated with recall that may have been prompted by, for example, media coverage.

If true, this would have been an important point to have made in the paper–or anytime in the 10 years after it’s publication. Not in a PCC complaint. That said, Mr. Deer points out where even Mr. Wakefield’s late admission is apparently false:

But this story cannot be reconciled with the children’s records as a whole. There were numerous notes of parents making the association later, whose testimonies he not only included in the paper, but adopted them as fact in his temporal calculations. For example, in the case of child 1, the GP writing to the Royal Free more than two years after the boy was vaccinated, described the parents’ association with MMR as their “most recent concern” as to the possible cause of his autism.

While on the subject of the PCC. What happened to Mr. Wakefield’s complaint? Turns out the PCC put it on hold until after the GMC hearings concluded. Mr. Wakefield never re-activated the complaint. He does refer to it (here’s an example from early 2011). Mr. Deer makes the case that the PCC complaint is an example of Mr. Wakefield using the complaints process (lawsuits, PCC, etc.) as debate tools. A point which if made would go to the argument that the defamation suit was filed frivolously.

As a related point– Mr. Wakefield *did* initiate an appeal of the GMC decision. He dropped it.

There is the (somewhat obvious, but I didn’t connect the dots as to the importance for the defamation case) fact that many of the details put forth in Mr. Wakefield’s “Secrets” series with the BMJ were first put forth in the lay press as MMR Doctor Fixed Data on Autism and Focus: Hidden records show MMR truth. Why is this important? Because Mr. Wakefield had 1 year from the data of first publication of statements to claim defamation, and these newspaper articles are from 2009, three years before the defamation claim. One wonders if this fact was made clear to Mr. Wakefield’s attorney in advance of filing the claim.

The following is more an observation of my own that something from the Brian Deer declaration. But, since Mr. Deer makes passing note of the recent “Health Freedom Expo” in Long Beach, California, I was reminded of this. Mr. Wakefield, together with a number of other members of the “vaccine epidemic” community. One thing I noticed when their talks were announced was the fact that speakers paid to give their talks. Under “register to speak” on the Health Freedom Expo website is listed “speaker fees”: $250 per 45-minute time slot. What I didn’t see before was this statement: You MUST be an Expo exhibitor to be a speaker. How much does it cost to be an exhibitor? Well, for the upcoming expo in Chicago, a standard booth costs $995. Did Mr. Wakefield (and his colleagues who spoke) pay $1245, plus travel expenses to attend? Plus the cost for a ballroom to host a fundraiser?

All these are tiny oddities in a long saga filled with much greater stories.

BMJ, Brian Deer file anti-SLAPP motion against Andrew Wakefield

11 Mar

About 2 months ago Andrew Wakefield filed a defamation lawsuit against the British Medical Journal, Brian Deer and Fiona Godlee for the series of three articles “The Secrets of the MMR Scare” and public comments made since. In particular, Mr. Wakefield took issue with statements about his research being fraudulent (and variations on that term like “fraudster”, “bullshit” etc.). Mr. Wakefield claimed that the facts presented by the BMJ articles were incorrect and based on information not available to him at the time he wrote his Lancet article.

Mr. Wakefield chose to file his defamation suit in Texas (his home state). This presented him immediately with two hurdles. First he has to show that the court has jurisdiction over primarily UK entities. Second he faced the possibility of an anti-SLAPP motion. SLAPP stands for “Strategic lawsuit against public participation“. Per Wikipedia:

A strategic lawsuit against public participation (SLAPP) is a lawsuit that is intended to censor, intimidate, and silence critics by burdening them with the cost of a legal defense until they abandon their criticism or opposition.

The typical SLAPP plaintiff does not normally expect to win the lawsuit. The plaintiff’s goals are accomplished if the defendant succumbs to fear, intimidation, mounting legal costs or simple exhaustion and abandons the criticism. A SLAPP may also intimidate others from participating in the debate. A SLAPP is often preceded by a legal threat. The difficulty, of course, is that plaintiffs do not present themselves to the Court admitting that their intent is to censor, intimidate or silence their critics. Hence, the difficulty in drafting SLAPP legislation, and in applying it, is to craft an approach which affords an early termination to invalid abusive suits, without denying a legitimate day in court to valid good faith claims.

Many states in the U.S. have enacted anti-SLAPP legislation. Texas enacted a law fairly recently and this motion could be the first major test of that law. I say “could” because of the first hurdle: jurisdiction. As Popehat has already noted, the plaintiffs in the anti-SLAPP motion “specially appear”. I.e. they keep the right to fight on jurisdictional grounds.

The motion and Mr. Deer’s supporting declaration can be found on Mr. Deer’s website. Mr. Deer’s declaration goes through the full history of his involvement with Mr. Wakefield’s research.

As Popehat notes, the motion appears quite strong. As is the case with legal motions, it covers multiple arguments. For example, they not only argue that the statements on their own are permissible speech, but they argue that the statements themselves are accurate.

Here is a section of the table-of-contents for the motion:

V. TEXAS’S NEW ANTI-SLAPP STATUTE APPLIES TO DR. WAKEFIELD’S CLAIMS.

VI. DR. WAKEFIELD’S CLAIMS FAIL BECAUSE HE CANNOT SHOW THAT THE CHALLENGED STATEMENTS ARE FALSE

A. Dr. Wakefield Must Prove that Defendants’ Statements Are Not Substantially True.
B. Dr. Wakefield Is Precluded from Re-litigating the GMC’s Findings, Which Establish the Substantial Truth of the Challenged Statements.
C. The Undisputed Evidence Also Establishes the Substantial Truth of the Challenged Statements.

1. Dr. Wakefield’s Misreporting and Falsification Permeated His Research.

2. Dr. Wakefield’s Undisclosed Conflicts of Interest.
3. Dr. Wakefield’s Review of the GP Records

VII DEFENDANTS’ STATEMENTS OF OPINION AND RHETORICAL HYPERBOLE ARE NOT ACTIONABLE.
A. Several of Defendants’ Statements, Including that Dr. Wakefield’s Research Must Have Been “Fraud,” Are Nonactionable Expressions of Opinion.
B. Defendants’ Expressions of Rhetorical Hyperbole and Colorful Language Are Not Actionable.

VIII DR. WAKEFIELD’S CLAIMS BASED ON BRIAN DEER’S WEBSITE PUBLICATIONS ARE BARRED BY THE STATUTE OF LIMITATIONS.
DR. WAKEFIELD IS A PUBLIC FIGURE, AND HE CANNOT SHOW ACTUAL MALICE.
A. Dr. Wakefield Is a Public Figure.
1. The “MMR Scare” Is a Public Controversy.
2. Dr. Wakefield Had More than a Trivial or Tangential Role in the
Scare.
3. Dr. Wakefield’s Claims Are Germane to His Participation in the
Controversy.
B. Defendants Did Not Act with Actual Malice.

1. Actual Malice Is an Exceedingly Difficult Standard to Satisfy.
2. The Evidence Here Precludes a Finding of Actual Malice.

Mr. Wakefield faces a number of burdens to overcome this motion. He must show that the statements made were more damaging that the truth. He must show that the statements are false–not just minor wording differences but that the “gist” of the truth is missing from the statements made. He must show that either he is not a public figure (very difficult for a doctor who has had a publicist for at least 10 years and has certainly put himself into the public sphere). He must show that Brian Deer, Fiona Godlee and the BMJ acted with actual malice.

He must present substantive evidence for each of these before he can go to trial. If he fails, he faces not only payment of reasonable legal fees and costs, but also the possibility of a penalty to deter future frivolous lawsuits. In that regard, the motion puts forth the history of Mr. Wakefield’s previous legal threats and lawsuits.

The most famous instance of Mr. Wakefield’s litigious history is his lawsuit against Brian Deer in 2004. Justice Eady made very clear statements on that:

[Dr. Wakefield] wished to use the existence of libel proceedings for public relations purposes, and to deter critics, while at the same time isolating himself from the ‘downside’ of such litigation, in having to answer a substantial defence of justification.

To put this in perspective–such a statement by the judge in Texas would almost certainly be followed by not only a dismissal of the case, but a financial judgement in favor of Mr. Deer, Ms. Godlee and the BMJ.

The motion makes it clear that Mr. Wakefield has faced negative commentary on his work and his character from many quarters in the past few years. From their introduction:

Two months ago, Dr. Andrew Wakefield was named by Time magazine as one of the “Great Science Frauds” of modern history. Last April, the New York Times described him as “one of the most reviled doctors of his generation.” In 2009, a Special Master presiding over vaccine litigation in the United States Court of Federal Claims recognized that Wakefield’s 1998 paper in The Lancet medical journal, which suggested a possible link between the lifesaving Measles, Mumps, and Rubella (“MMR”) vaccine and the development of autism in children, was considered a “scientific fraud.”

The Lancet has now fully retracted Wakefield’s paper, and its editor has state publicly that the paper was “utterly false” and that Wakefield “deceived the journal.” Wakefield’s home country’s medical board, the United Kingdom’s General Medical Council (“GMC”), convicted him in 2010 of multiple charges of “serious professional misconduct,” including “dishonesty” and “unethical conduct.” It further held that his misconduct had been so severe and extensive that the only punishment that would adequately protect the public from him was the permanent revocation of his medical license. As the New York Daily News put it, “Hippocrates would puke.”

As to specific instances of calling Mr. Wakefield’s work fraudulent, they quote multiple instances of the term being used. As noted above, one of the Special Masters in the Omnibus Autism Proceeding (vaccine court) called the work “scientific fraud”. Probably the most damaging instance for Mr. Wakefield are quotes from his own attorney in the General Medical Council (GMC) hearings who stated that some of the charges, if found proved, would amount to charges of fraud. Those charges were found proved.

There is definitely a movement amongst Mr. Wakefield’s supporters to recast his defamation suit as a retrial of not only his Fitness to Practice hearing before the GMC, but as a legal test of the validity of his MMR/autism hypothesis. Even just within the past couple of days Jenny McCarthy re-emerged in her role as a vocal Wakefield supporter with this (and other) erroneous arguments.

Courts are well aware of attempts for people to use defamation cases as a proxy for fighting other arguments. For example, readers might recall a recent defamation case where Barbara Loe Fisher (of the self-named National Vaccine Information Center) sued Dr. Paul Offit, writer Amy Wallace and Conde Nast publications for two words in an article: “she lies”. In the decision dismissing the defamation suit the judge noted:

Not only does Plaintiff’s claim of the statement’s falsity invite an open ended inquiry into Plaintiff’s veracity, it also threatens to ensnare the Court in the thorny and extremely contentious debate over the perceived risks of certain vaccines….and, at the bottom, which side has the truth on its side. This is hardly the sort of issue which would be subject to verification based on a core of “objective evidence”

and

Courts have a justifiable reticence about venturing into a thicket of scientific debate, especially in the defamation context

However, one must note that Mr. Wakefield’s defamation suit does *not* involve the issues of his research conclusions/findings (or non-findings as they have been retracted from the public sphere). The question put forth by Mr. Wakefield was whether statements such as “fraud”, “fraudster”, “determined cheat” are actionable defamation and whether these are based on allegedly misrepresented details from the research–such as diagnoses of the children and when symptoms appeared. Mr. Deer shows in his declaration that the facts presented in the BMJ studies are accurate.

On the “weight of evidence” front, consider this: Mr. Wakefield submitted a 17 page defamation claim. The defendants have responded with a 53 page anti-SLAPP motion and 5 declarations. The declarations include one from Mr. Deer with 101 pages and 104 exhibits. Where Mr. Wakefield is using a neighbor as his attorney, one who is not a specialist in health, media or defamation cases, the BMJ team are using a top Texas law firm and a total of seven attorneys. The lead attorney is listed as having experience with healthcare and publishers:

Tom has a wide range of experience in state and federal appeals and trials. His experience includes commercial, intellectual property, and healthcare litigation, and class actions. He has represented publishers and broadcasters in all aspects of media litigation throughout his career.

the second attorney listed has direct experience on defamation:

Marc’s practice focuses on media and privacy law, class actions, and general commercial litigation. His media law experience includes representing publishers in litigation involving claims for defamation, invasion of privacy, misappropriation, copyright, and related causes of action. In addition, he has defended companies in consumer class actions across the country relating to advertising and digital privacy. He regularly provides advice regarding website terms of service, arbitration agreements, and privacy law.

According to the BMJ’s motion, ” To avoid dismissal, the plaintiff [Mr. Wakefield] must submit “clear and specific evidence” to support each essential element of his claims.”

I suspect that Mr. Wakefield will have a meeting with his attorney very soon to discuss strategy. They are outclassed on the facts of the case, on the manpower and expertise of the attorneys and the credibility of the witnesses. They will discuss “each essential element of his claims” and how they stack up against the evidence presented. One might suspect that Mr. Wakefield’s attorney was unaware of how shaky their position was at the start, getting his facts from Mr. Wakefield. They now know, through hundreds of pages of arguments and evidence, how the defense can answer the “essential claims”.

If they can dismiss before the jurisdiction question is addressed and avoid the anti-SLAPP motion, they might be well advised to do so. The “reasonable costs” the BMJ are incurring are sure to be sizable. And the litigious history of Mr. Wakefield will surely play into a determination of whether to impose penalties on top of those.

From where I sit, Mr. Wakefield just doesn’t have the facts on his side. Nor does he have the law on his side. The jurisdiction question may be a blessing in disguise for Mr. Wakefield: giving him the opportunity to bow out before the anti-SLAPP motion goes into effect.

Walker-Smith wins appeal

7 Mar

Prof. John Walker-Smith was one of Andrew Wakefield’s colleagues at the Royal Free and participated in the research there. Prof. Walker-Smith was struck off the medical register along with Andrew Wakefield by the General Medical Council. Prof. Walker-Smith appealed and the GMC’s decision has been quashed.

Here is the conclusion of the appeal decision:

For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel’s overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion. Miss Glynn submits that the materials which I have been invited to consider would support many of the panel’s critical findings; and that I can safely infer that, without saying so, it preferred the evidence of the GMC’s experts, principally Professor Booth, to that given by Professor Walker-Smith and Dr. Murch and by Dr. Miller and Dr. Thomas. Even if it were permissible to perform such an exercise, which I doubt, it would not permit me to rescue the panel’s findings. As I have explained, the medical records provide an equivocal answer to most of the questions which the panel had to decide. The panel had no alternative but to decide whether Professor Walker-Smith had told the truth to it and to his colleagues, contemporaneously. The GMC’s approach to the fundamental issues in the case led it to believe that that was not necessary – an error from which many of the subsequent weaknesses in the panel’s determination flowed. It had to decide what Professor Walker-Smith thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions fell outside the spectrum of that which would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question is an error which goes to the root of its determination.

The panel’s determination cannot stand. I therefore quash it. Miss Glynn, on the basis of sensible instructions, does not invite me to remit it to a fresh Fitness to Practice panel for redetermination. The end result is that the finding of serious professional misconduct and the sanction of erasure are both quashed.

From The Telegraph’s MMR doctor wins battle against being struck off:

A doctor found guilty of serious professional misconduct over the MMR controversy has won his High Court appeal against being struck off.

And:

Chief executive Niall Dickson added: “Today’s ruling does not however reopen the debate about the MMR vaccine and autism.

“As Mr Justice Mitting observed in his judgement, ‘There is now no respectable body of opinion which supports (Dr Wakefield’s) hypothesis, that MMR vaccine and autism/enterocolitis are causally linked’.

Cochrane Reports: Vaccines for measles, mumps and rubella in children (Review)

22 Feb

The Cochrane collaboration has put out an updated report on the MMR vaccine.

Online discussions (for example, here) are (a) focused on the abstract only so far and (b) centered on two lines from the abstract:

Exposure to the MMR vaccine was unlikely to be associated with autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn’s disease, demyelinating diseases, bacterial or viral infections

and

The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate

Here is the full abstract from the paper:

Background
Mumps, measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness, disability and death. However, public
debate over the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists, despite its almost universal use and accepted effectiveness.

Objectives
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age.

Search methods
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2),
which includes the Cochrane Acute Respiratory Infections Group’s Specialised Register, PubMed (July 2004 to May week 2, 2011)
and Embase.com (July 2004 to May 2011).

Selection criteria
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo, do nothing or a combination of measles, mumps and rubella antigens on healthy individuals up to 15 years of age.

Data collection and analysis
Two review authors independently extracted data and assessed methodological quality of the included studies. One review author
arbitrated in case of disagreement.

Main results
We included five randomised controlled trials (RCTs), one controlled clinical trial (CCT), 27 cohort studies, 17 case-control studies, five time-series trials, one case cross-over trial, two ecological studies, six self controlled case series studies involving in all about 14,700,000 children and assessing effectiveness and safety of MMR vaccine. Based on the available evidence, one MMR vaccine dose is at least 95% effective in preventing clinical measles and 92% effective in preventing secondary cases among household contacts.
Effectiveness of at least one dose of MMR in preventing clinical mumps in children is estimated to be between 69% and 81% for the
vaccine prepared with Jeryl Lynn mumps strain and between 70% and 75% for the vaccine containing the Urabe strain. Vaccination
with MMR containing the Urabe strain has demonstrated to be 73% effective in preventing secondary mumps cases. Effectiveness of
Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children and adolescents was estimated to be between
64% to 66% for one dose and 83% to 88% for two vaccine doses. We did not identify any studies assessing the effectiveness of MMR in preventing rubella.

The highest risk of association with aseptic meningitis was observed within the third week after immunisation with Urabe-containing
MMR (risk ratio (RR) 14.28; 95% confidence interval (CI) from 7.93 to 25.71) and within the third (RR 22.5; 95% CI 11.8 to
42.9) or fifth (RR 15.6; 95% CI 10.3 to 24.2) weeks after immunisation with the vaccine prepared with the Leningrad-Zagreb strain.
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 1.10; 95% CI 1.05 to
1.15) was assessed in one large person-time cohort study involving 537,171 children aged between three months and five year of age. Increased risk of febrile seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 4.09; 95% CI 3.1 to 5.33) and children aged 12 to 35 months (RI 5.68; 95% CI 2.31 to 13.97) within six to 11 days after exposure to MMR vaccine. An increased risk of thrombocytopenic purpura within six weeks after MMR immunisation in children aged 12 to 23 months was assessed in one case-control study (RR 6.3; 95% CI 1.3 to 30.1) and in one small self controlled case series (incidence rate ratio (IRR) 5.38; 95% CI 2.72 to 10.62). Increased risk of thrombocytopenic purpura within six weeks after MMR exposure was also assessed in one other case-control study involving 2311 children and adolescents between one month and 18 years (odds ratio (OR) 2.4; 95% CI 1.2 to 4.7). Exposure to the MMR vaccine was unlikely to be associated with autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn’s disease, demyelinating diseases, bacterial or viral infections.

Authors’ conclusions
The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The
evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target
diseases.

The body of the paper summarizes the accepted papers and judges papers on criteria such as potential for bias and generalizability.

While much discussion online is given to the short abstract available in pubmed, consider the last three sections of the paper.

First, “Agreements and disagreements with other studies or reviews”

Agreements and disagreements with other studies or reviews
Currently, this is the only review covering both effectiveness and safety issues ofMMR vaccines. In agreement with results from other studies and reviews a significant association between autism and MMR exposurewas not found.The study of Wakefield (Wakefield 1998), linking MMR vaccination with autism, has been recently fully retracted (The Editors of The Lancet 2010) as Dr.Wakefield has been found guilty of ethical,medical and scientific misconduct in the publication of the paper; many other authors have moreover demonstrated that his data were fraudulent (Flaherty 2011). A formal retraction of the interpretation that there was a causal link between MMR vaccine and autism has already been issued in year 2004 by 10 out of the 12 original co-authors (Murch 2004). At that time (1998) an excessive and unjustified media coverage of this small study had disastrous consequences (Flaherty 2011; Hilton 2007; Offit 2003; Smith 2008), such as distrust of public health vaccination programmes, suspicion about vaccine safety, with a consequential significant decrease in MMR-vaccine coverage and re-emergence of measles in the UK.

Let’s look at the “Authors Conclusions” section at the end the paper:

AUTHORS’ CONCLUSIONS

This is in two sections:

first:

Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication and in order to reduce morbidity and mortality associated with mumps and rubella.

Repeat for emphasis: Existing evidence supports the current policies of mass immunisation.

This is followed by “implications for research”:

Implications for research
The design and reporting of safety outcomes in MMR vaccine studies, both pre and post-marketing, need to be improved and standardised definitions of adverse events should be adopted. More evidence assessing whether the protective effect of MMR could wane with the time since immunisation should be addressed.

At this point I’ll point out what I see as a false dichotomy. The discussion is not between “should vaccination continue” and “are the studies adequate” as some have framed it. Clearly Cochrane has called for both continued immunization *and* more research. This includes research into “assessing whether the protective effect of MMR could wane with the time since immunisation”, something which could point to the need for booster shots.

How about the MMR/autism question?

First off, let’s note that four of Mr. Wakefield’s papers were considered for the review. All four were rejected.

Wakefield 1998 {published data only}
Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al.Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998;351(9103):637–41.

Wakefield 1999a {published data only}
Wakefield AJ, Montgomery SM. Autism, viral infection and measles-mumps-rubella vaccination. Israel Medical
Association Journal 1999;1(3):183–7.

Wakefield 1999b {published data only}
Wakefield AJ. MMR vaccination and autism. Lancet 1999; 354(9182):949–50.

Wakefield 2000 {published data only}
Wakefield AJ, Montgomery SM. Measles, mumps, rubella vaccine: through a glass, darkly. Adverse Drug Reactions and
Toxicological Reviews 2000;19(4):265-83; discussion 284- 92.

Oddly, while the body of the Cochrane review notes that Wakefield 1998 has been retracted, the citation does not. The paper should either not be cited (as it has been effectively erased from the public record) or the citation should include the term “retracted”. The retraction is not the given reason for rejecting the study from the review. It was rejected due to being a case series. Wakefield 1999a and was rejected for lack of comparative data while Wakefield 1999b because it has no data.

As already quoted above, the authors of the Cochrane review *do* take notice of the GMC hearing and the Lancet retraction:

“The study of Wakefield (Wakefield 1998), linking MMR vaccination with autism, has been recently fully retracted (The Editors of The Lancet 2010) as Dr. Wakefield has been found guilty of ethical,medical and scientific misconduct in the publication of the paper; many other authors have moreover demonstrated that his data were fraudulent (Flaherty 2011).”

I note the statement that “many other authors have moreover demonstrated that his data were fraudulent ” First, the Cochrane Report is reporting that the data have been “demonstrated” to be fraudelent. Further, not “The BMJ” have claimed that the data were fraudulent, but “many other authors”.

In what I see as a strange move, the Hornig study (Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.) was not considered by Cochrane with the given reason “Subjects affected by gastrointestinal disturbance”. Hornig et al. was the most on-target attempt to reproduce multiple critical aspects of Mr. Wakefield’s work.

What studies *were* included? Here’s the list, together with how Cochrane rated them for “risk of bias” and “generalisability”
Madsen 2002 moderate/high
Fombonne 2001 high/low
Uchiyama 2007 high/low
Smeeth 2004 moderate/medium
DeStefano 2004 moderate/medium
Mrozek-Budzyn 2010 moderate/medium
Fombonne 2006 moderate/medium
Honda 2005 moderate/medium
Makela 2002 moderate/medium
Taylor 1999 moderate/medium

To close, I’ll repeat the “implications for practice”:

Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication and in order to reduce morbidity and mortality associated with mumps and rubella.

Attorney for Prof. Walker-Smith: alleged link between MMR and autism utterly disproved

14 Feb

Prof. John Walker-Smith was a colleague of Andrew Wakefield, a co-author on the no-retracted 1998 Lancet paper and shared the same fate as Mr. Wakefield after the General Medical Council Hearings: he was struck off the medical register. Prof. Walker-Smith has appealed (Mr. Wakefield did not). A few news stories have come up about this appeal. In Doctor struck off over MMR controversy appeals against ruling, the Guardian notes:

Prof John Walker-Smith tells high court he was denied a fair hearing before he was struck off by the General Medical Council

Many are looking to this appeal for vindication of Mr. Wakefield and his theories on MMR being linked to and causal in autism. Prof. Walker-Smith’s attorney appears to have made a rather clear statement to the contrary:

Miller said it had been important that the disciplinary panel “separate out research from the clinical medicine – but that was a task that appeared to be beyond them”.

The judge asked Miller whether the alleged link between MMR and the vaccine “has now been utterly disproved” in the opinion of “respectable medical opinion”.

Miller said that was “exactly” the position.

edit to add:

I took the statement “The judge asked Miller whether the alleged link between MMR and the vaccine “has now been utterly disproved” ” to be a mistaken report by the Guardian because, as written, it does not make sense. My own interpretation was that the actual question was whether the MMR and *autism* was the point. However, I should have made that assumption very clear in the above piece and I apologize for that. I have written the paper as well as some other people who might be able to clarify the statement.

Transcripts from the GMC hearings

2 Feb

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.

Time Magazine: Great Science Frauds

14 Jan

Add Time magazine to the list of those calling out Andrew Wakefield a fraud. Not just any fraud, a “great science fraud”:

Great Science Frauds

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