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A new Autism Media Channel video. A chance to watch some sleight of hand

17 Oct

Andrew Wakefield has a new video with stunning new revelations of malfeasance by the CDC. Well, that’s what he wants you to think. Let’s take a look and see how well his story stands up to scrutiny, shall we? To do this I’ll highlight two of the problems with the video.  The first I’ve already discussed some: Mr. Wakefield claims the CDC hid a result but the CDC actually published it. For the second problem, let’s follow Mr. Wakefield as he creates a timeline showing us how the CDC’s research plan was supposedly revised in response to some analysis results.  Then let’s piece together the real timeline.

We will start with problem one. The basic idea of Mr. Wakefields argument in his new video is that the CDC hid an association in a group of kids allegedly susceptible to becoming autistic due to the MMR. This group are those with “isolated autism”: autism without intellectual disability, birth defects or other possible cause.

There’s a lot of smoke and mirrors in the video, but here’s the main result.  An increased odd ratio for “isolated autism” for kids vaccinated before 36 months.  Calculated odds ratio is 2.48.  With a confidence interval that doesn’t span 1 (1.16 to 5.31).

Wakefield smoke and mirrors

There’s much drama in the video about this.  For example, here’s what Brian Hooker had to say (about 3:25 into the video).

What CDC employees do, when they see an effect, then they will get in a room together and they will work until that association goes away

Followed by Mr Wakefield:

But that didn’t seem to happen. They deviated further from the analysis plan by limiting the isolated group to only those with no mental retardation. Even changing the age categories and composition of the isolated subgroup may not have achieved the desired effect. Since, in the end, the simply omitted the relevant findings from the paper altogether.

That’s an amazing claim, isn’t it? The CDC allegedly just buried the result.  “Omitted the findings altogether.”

Except that the CDC didn’t hide the result. They reported on autism without MR. Here’s table 4 from the paper in Pediatrics.

Destefano_table_4 highlighted

If you want to say, “well autism without MR isn’t the same thing as ‘isolated autism’, consider this: the answer is basically unchanged from what Mr. Wakefield claims was “omitted”.   Take a look at the table: in the total sample, the group without MR has basically the same result as was supposedly hidden.   Odds ratio 2.45 (compared to 2.48), with confidence interval from 1.20 to 5.00 (compared to 1.16 to 5.31).  Which is to say: the CDC published the result that Mr. Wakefield claims was hidden.

Smoke.  Mirrors.  Wakefield.  Hooker.

This result is 10 years old.  And no one, not Wakefield, Not Hooker, not anyone in the real advocacy community has made a big deal out of it until now. I do not profess to understand how Mr. Wakefield nor Mr. Hooker think, but here’s one reason why most people haven’t considered this “autism without MR” result a big deal:  this is a raw data result.  A result unadjusted for any possible confounders.  The adjusted result, also highlighted in the figure above, shows a confidence interval that spans 1.  In other words, there’s no suggestion of a real effect when one does a full analysis.

Which of course shows us why people do full analyses.  Sometimes associations change when one controls for other factors.  Sometimes associations get stronger.  Sometimes they go away.  Sometimes things that appear to not be associations are shown to be associations.

Now that we’ve seen that the conclusion from Mr. Wakefield’s video is wrong, let’s consider a second problem with this new video: the way in which Mr. Wakefield manipulates his audience.  He creates a timeline for the CDC’s actions that allows Mr. Wakefield to use his new favorite “f” word.  Fraud.  Let’s go through the timeline.

At about 2:20 in the video, Mr. Wakefield shows us a fraction of a page of the analysis plan. The protocol. Dated September 5, 2001.

draft analysis plan screenshot

We then get this ominous voiceover. Complete with the analysis plan page going up in flames. Very dramatic:

“Over the ensuing months, after the data after the data had been collected and analyzed, and strictly forbidden in the proper conduct of science, the group abandoned the approved analysis plan, introducing a revised analysis plan to help them deal with their problem.”

And to “prove” that months later the CDC introduced a new analysis plan we are shown notes supposedly documenting that the CDC team were creating that revised plan:

Scary Revised Analysis Plan Screenshot

You are supposed to say, “they revised the analysis plan!  That’s bad!” But do you see what I see? That these are notes from September 6, 2001 2011?  Not after the “ensuing months” but one day later after the plan was finalized. I guess we weren’t supposed to look at the date, just the scary words “revised analysis plan”.

From these notes it appears to say that there will be a records review on September 12th and that in advance of that, whoever wrote these notes needs to get the revised analysis plan. Not, “hey, let’s fabricate a new analysis plan” but, “Hey, the plan was revised yesterday and I should get a copy”. Or, to put it another way: how sinister does the note read sound when the plan was just finalized the day before?

So, when did the CDC do the analysis that Mr. Wakefield shows in his video?  You know, the analysis that the “revised” plan was supposed to avoid?  November, 2001.  Two months later after the plan was finalized and, importantly, two months after those notes were taken. Here’s a screenshot from a talk Mr. Hooker recently gave about his work and the DeStefano paper.  He showed one of the same tables that Mr. Wakefield uses in his video (29:11 into the video).  Notice the date? November 7. In the audio he says “they did see a statistically significant result as early as November 7th, 2001″.  Mr. Wakefield’s first video (the ugly, race-baiting one) also references the November 7th meeting.  So it looks like this is the earliest evidence Mr. Wakefield and Mr. Hooker have  of the CDC obtaining results for this study.

Hooker_CDC

Now, let’s compare how Mr. Wakefield presented a chain of events and what actually happened.

The impression Mr. Wakefield gives in his video is that:

(a) first the plan for the research was finalized by the CDC team,

(b) then they found data which showed an effect they didn’t like and

(c) after “ensuing months” the CDC team then held a meeting in which notes were taken that they had to revise the plan.

Here’s what the actual events appear to be

(a) the research plan was finalized on Sept. 5,

(b) on Sept. 6, someone (likely Mr. Thompson) took notes that he had to get the revised plan and

(c) on November 7, what appears to be the first pass at data analysis were presented presented in an internal CDC meeting.

No evidence of revising the plan after the analysis.  The image of the meeting notes are being used as props to craft a story. Andrew Wakefield apparently doesn’t understand the first rule of documentaries.  And apparently whatever ability he had for reporting factually has long since faded since he left grad school.

And, Brian Hooker?  He’s not just a prop in these videos.  He’s an active participant.  His organization has paid Mr. Wakefield for at least the first video.  The race-baiting video.

The autism communities deserve better. Better than Andrew Wakefield.  Better than Brian Hooker.

By Matt Carey

A look at the analysis plan for DeStefano’s MMR study: no evidence of fraud

16 Oct

Andrew Wakefield and Brian Hooker have been making claims that the CDC are involved in misconduct in autism research. In case you haven’t followed the story, it basically goes like this:

1) the CDC planned on a study of MMR and autism using the MADDSP data.

2) That the CDC created a research plan.

3) That the CDC found results they didn’t want to report: an calculated odds ratio for African American boys. So the CDC team allegedly deviated from that plan and didn’t report that result.

4) That the CDC introduced a new analysis after the plan: that they would include birth certificate data.  While the CDC rationale for this new analysis was to provide more data (confounding variables) for the analysis, the allegedly real reason was to dilute the sample set and make statistically significant results disappear.

Here’s a paragraph from one of the press releases about the Hooker study:

According to Dr. Thompson’s statement, “Decisions were made regarding which findings to report after the data was collected.” Thompson’s conversations with Hooker confirmed that it was only after the CDC study coauthors observed results indicating a statistical association between MMR timing and autism among African-Americans boys, that they introduced the Georgia birth certificate criterion as a requirement for participation in the study. This had the effect of reducing the sample size by 41% and eliminating the statistical significance of the finding, which Hooker calls “a direct deviation from the agreed upon final study protocol – a serious violation.”

Or so goes the story. But as is often the case with Andrew Wakefield and Brian Hooker, the facts don’t match the claims.

In a recent video, Mr. Wakefield shows us the research plan the CDC had drafted.  One red flag with Mr. Wakefield’s approach so far has been how he tries to tightly manage the flow of information.  He has not shared the analysis plan in total and only now has he provided us with a couple screenshots.  Begs the question: what are they hiding?

Here’s one screenshot from that video. This one is where he gets the idea that the plan was to report race for the entire sample.

draft analysis plan screenshot 2

Here’s the full text, in case that’s difficult to read:

Statistical Analysis

We will use conditional logistic regression stratified by matched sets to estimate the odds ratios for association between age at MMR vaccination and autism. In the main analyses, we will include all autism cases.

Potential confounding variables will be evaluated individually for their association with the autism case definition. Those with an odds ratio p-value < 0.20 will be included as covariates in a conditional logistic regression model to estimate adjusted odds ratios for the association between age at vaccination and autism. The only variable available to be assessed as a potential confounder using the entire sample is child’s race. For the children born in Georgia for whom we have birth certificate data, several sub-analyses will be carried out similar to the main analyses to assess the effect of several other potential confounding variables. A recent case control study (CDC, 2001) carried out with a subset of the autism cases from this study found that age matched cases and controls differed on several important background factors including maternal age, maternal education, birth type, and parity. The variables that will be assessed as potential confounders in this study will be birth weight, APGAR scores, gestational age, birth type, parity, maternal age, maternal race/ethnicity, and maternal education. (See Table 2 for how variables will be categorized.)

There are two interesting points in the above.  First, the sentence Mr. Wakefield highlights doesn’t say what he claims.  The only variable available to be assessed as a potential confounder using the entire sample is child’s race. The plan doesn’t say that they will test and report race.  Consider the context: this is a section of the plan called “statistical analysis”. Put in context with the entire paragraph, this sentence is clear: the full dataset is limited because it only has one variable available.

The CDC didn’t deviate from the plan when they didn’t report on race for the total sample because that was never in the plan.  If you want more evidence of this, the end of the paragraph says “See Table 2 for how variables will be categorized”.  Table 2 is titled “Descriptive Statistics for Children Born in Georgia with Birth Certificate Records”.  The variables will be categorized in the birth certificate sample.

The second interesting point from the paragraph Mr. Wakefield has shown us is this: the CDC plan included a birth certificate sample.

Here’s a screenshot of the analysis plan from that new video, showing the front page of the analysis plan:

draft analysis plan screenshot

Shown with this voice over by Mr. Wakefield (while the screenshot above is shown going up in flames…very dramatic)

“Over the ensuing months, after the data after the data had been collected and analyzed, and strictly forbidden in the proper conduct of science, the group abandoned the approved analysis plan, introducing a revised analysis plan to help them deal with their problem.”

So, in case you were thinking, “that’s an analysis plan, how do we know it’s the analysis plan”, well, you have Mr. Wakefield’s word on it.  This is the “approved analysis plan” that the CDC allegedly had to revise.

What interests me about this as that’s the same plan that I have and was preparing to write about.  It’s nice now to be able to be able to say that this is, indeed, the same document that Mr. Wakefield and Mr. Hooker are working with.

We’ve already seen two big mistakes by the Wakefield/Hooker team: first that the analysis plan doesn’t include a call to report on race separately in the total sample (the group without the birth certificates), second that the CDC “approved analysis plan” included analysis of a subset with birth certificate data.

So, what were the objectives of the study as in the plan?

Objectives:
We did not have information regarding onset of symptoms for most cases in this study and this limited our ability to do certain types of analyses such as case series analyses. In addition, a totally unexposed group (i.e., never received the MMR vaccine or other measles containing vaccine) was not available since measles, mumps, and rubella vaccination are required for school attendance in Georgia. The following objectives are considered the primary objectives for this study.
1) To determine if case children were more likely than their matched controls to have been vaccinated with MMR before 36 months of age. DSM-IV criteria for autism require that onset of symptoms occur before 36 months of age. Therefore, the 36-month cut-off is one that by definition can be used to classify a definitely “unexposed” group.
2) To determine whether there was a difference between cases and controls in the proportion of children exposed to their first dose of MMR vaccine before 18 months of age. This objective is based on the research that suggests the timing of first parental concern for the development of autism appears around 18 months of age (Taylor et al, 1999). In addition, Cathy Lord has reported that the range of first parental concern for regression was between 12 and 23 months of age with a mode of 19-21 months.
3) To determine whether the age distribution for receipt of the MMR vaccine differs between cases and controls.

They showed the data for the 36 and 18 month cutoffs.  Age distribution was covered in Table 2.

Analysis of Autism subgroups

The IOM (2001) specifically recommended additional research regarding autism subgroups and MMR. We will examine several subtypes of autism in this study. Data from the Metropolitan Atlanta Congenital Defects Program will be included in the sub-analyses to identify particular sub-groups. The following sub-group analyses will be conducted:

1) Analyses excluding cases with an established cause for autism or a co-occurring condition suggesting an early prenatal etiology (e.g., tuberous sclerosis, fragile X, or other congenital/chromosomal anomalies.)

We propose to conduct a case-control sub-analysis looking at cases without an established or presumptive cause for autism, such as tuberous sclerosis, fragile X, and other congenital/chromosomal anomalies. The purpose of doing this analysis is to create a more homogeneous case group that may be more likely to be impacted by the timing of the MMR vaccine. The objectives from the primary analyses will be replicated in this sub-analysis.

2) Analyses of Isolated versus Non-isolated Autism.

Isolated autism cases are cases with no other co-morbid developmental disability while non-isolated cases do have a co-morbid developmental disability. Previous research suggests that the majority of non-isolated cases have a co-existing developmental disability of mental retardation (CDC, 2001). Both isolated and non-isolated cases will be compared separately to controls. The objectives from the primary analyses will be replicated in this sub-analysis.

3) Analyses examining Gender Effects

Males are at substantially higher risk for autism and may be more vulnerable to the exposure associated with the MMR vaccine. We will analyze males and females separately and replicate the main objectives of the primary analyses as well as examine the potential confounders available from Georgia birth certificates.

4) Analyses excluding autism cases with known onset prior to 1 year of age.

For a subset of autism cases, we were able to identify the timing of parental concern. This sub-analysis will exclude all cases excluded with an established or presumptive cause for autism (e.g., tuberous sclerosis, fragile X, and other congenital/chromosomal anomalies.) and children for whom we have been able to identify first parental concern prior to 12 months of age.

Just in case anyone reading this is one of the few that has been following Mr. Wakefield’s video releases: in a new video Mr. Wakefield is trying to claim that the isolated autism subanalysis was not done.  Except that it was.  They made a minor change to autism without MR, which gave essentially the same result that Mr. Wakefield claims was hidden.

Destefano_table_4 highlighted

Autism without MR has an odds ratio of 2.45 with a 95% confidence interval of 1.20 to 5.00.  I’ll write about this new video soon as there’s much sleight of hand going on, but Mr. Wakefield is claiming that a result of odd ratio = 2.48 with confidence interval of 1.16 to 5.31 was not reported.  Besides ignoring the fact that the data were reported by the CDC, Mr. Wakefield ignores the fact that these are raw-data results.  Total sample, unadjusted analysis.  In the adjusted analysis the result does not suggest an association.

But, getting back to the main point: the claims of fraud are just not founded on fact.  The two main claims of “fraud” are just wrong.  The analysis plan did not state that they would do a subanalysis by race for the total sample.  The addition of the birth certificate data is in the plan, not in some sort of revision.  And Mr. Wakefield and Mr. Hooker knew this.

I am reminded of a quote from an ABC News article recently

“There are always going to be those people at the edges of science who want to shout because they don’t want to believe what the data are showing,” said Dr. Margaret Moon, a pediatrician and bioethicist at Johns Hopkins Berman Institute of Bioethics. She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

“It’s not good. It’s not fair. It’s not honest. But it’s savvy,” Moon said.

By Matt Carey

The Quacks behind the Warrior Moms

13 Oct

I accept Dr Carpenter’s opinion that there is no evidence that any of these treatments were individually beneficial for M and that collectively they were intrusive and contrary to his best interests.  M’s life was increasingly dominated by the programme of treatment to the exclusion of other activities.  I find that E has implemented a programme of diet, supplements and treatments and therapies indiscriminately, with no analysis as to whether they are for M’s benefit, and on a scale that has been oppressive and contrary to his interests.  She has exercised total control of this aspect of M’s life.’

Mr Honourable Justice Baker, In the Court of Protection, Judgment, In the matter of the Mental Capacity Act 2005 and in the matter of M, 11 August 2014

Brian Deer has once again done a service to the autism community, by putting in the public domain the judgment of Mr Justice Baker in the case arising from a dispute between a local authority and the mother (E) and father (A) of a young man (M) with autism.

http://briandeer.com/solved/mother-lied-protection-news.htm

Deer’s report, published in the Sunday Times on 12 October, focuses on the judge’s scathing judgment on E, a prominent supporter of the claim by the discredited Royal Free researcher Andrew Wakefield of a link between the MMR vaccine and autism. Mr Justice Baker concluded that E had fabricated evidence of an adverse reaction to MMR in her son, invented a range of associated diagnoses, subjected her son to unnecessary tests and treatments, neglected a dental abscess and indulged in fantasy conspiracy theories.

This Court of Protection case offered a rare opportunity to ventilate in public some of the controversies that have raged in the world of autism over the past decade. In the USA, the Omnibus Autism proceedings in 2008-9 provided a public forum in which claims regarding vaccine-autism links and associated alternative treatments were exposed as scientifically baseless and clinically irresponsible.

http://www.spiked-online.com/newsite/article/6283#.VDqLgWd0yUk

Though Mr Justice Baker did not address the MMR link or alternative treatments in general, his 92 page report provides a devastating indictment of the role of a range of therapists in relation to M, some of whom appeared as witnesses. In addition to exclusion diets and supplements, M received homeopathy, cranial osteopathy, reflexology, naturopathy, light and sound therapy, auditory integration training and hyperbaric oxygen therapy. It is clear that E’s descent into irrationality and paranoia was supported and encouraged by a number of dubious authorities and therapists, with damaging consequences for her son and her family.

Three therapists gave evidence in support of E’s treatment of her son. Shelley Birkett-Eyles, an occupational therapist working in a private clinic, was accepted by Mr Justice Baker as a ‘responsible practitioner’, though he noted that her reliability was challenged by Dr Peter Carpenter, a consultant psychiatrist with a special interest in learning disability, the expert witness called by the local authority.

Dr Peter Julu describes himself as ‘autonomic neurophysiologist’ (based at the private Breakspear Clinic), though Mr Justice Baker questioned whether this was a legitimate speciality and noted that his diagnosis of ‘neurodevelopmental dysautonomia’ was disputed by Dr Carpenter, who also challenged the reliability of his assessments and treatments, particularly his recommendation of hyperbaric oxygen therapy.

Ms Juliet Hayward, a nutritional therapist, was censured for giving ‘advice well beyond her expertise’, in endorsing a diagnosis of Lyme Disease and in prescribing a dietary protocol without taking an adequate medical history. Mr Justice Baker concluded that he ‘was left with a profound anxiety about Ms Haywood’s influence on E and her role in the treatment that M has received.’

Mr Justice Baker was particularly concerned that none of these three had received training in issues of ‘mental capacity’ as codified in the 2005 Mental Capacity Act. He observed that ‘it was clear from their evidence that none of them had given proper consideration to the question whether M had capacity to consent to their assessments or the treatment they were prescribing’.

In addition to these therapists, E called as expert witnesses two veterans of the Wakefield anti-MMR campaign: Dr Ken Aitken, a clinical psychologist formerly associated with the (now defunct) Autism Treatment Trust providing alternative treatments in Edinburgh; and Mr Paul Shattock, a retired pharmacy lecturer from Sunderland, a long-standing promoter of exclusion diets and unorthodox biomedical therapies.

http://www.spiked-online.com/newsite/article/5992#.VDqNsWd0yUk

By contrast with other expert witnesses (including Dr Peter Carpenter, Dr Alison Beck, Professor Robin Williamson, Dr Gwyn Adshead, Mr Keith McKinstrie), whom Mr Justice  Baker found to be ‘wholly reliable and professional’, he expressed considerable reservations about Aitken and Shattock:

‘I was concerned at times as to their qualifications to opine on some of the matters about which they gave evidence.’

In his conclusion, Mr Justice Baker categorically rejected the approach advocated by Aitken and Shattock in relation to M:

‘I stress, again, that I am not making any definitive findings on the efficacy of alternative treatments generally.  That is not the subject of these proceedings, which are about M.  I do, however, find that: (1) there is no reliable evidence that the alternative treatments given to M have had any positive impact on people with autism generally or M in particular and (2) the approach to prescribing alternative treatments to and assessing the impact of such treatments on people with autism in general and M in particular has lacked the rigor and responsibility usually associated with conventional medicine.’

Mr Justice Baker repudiated ‘the fallacy’ of E’s belief that there are two parallel approaches to the diagnosis and treatment of autism, each of which is equally valid:

‘The evidence in this hearing has demonstrated clearly that there is one approach – the clinical approach advocated by Dr Carpenter – that is methodical, rigorous and valid, and other approaches advocated by a number of other practitioners, for which there is no evidence of any positive impact and which (in this case at least) have been followed with insufficient rigor.  Whilst each treatment may be harmless, they may, if imposed collectively and indiscriminately, be unduly restrictive and contrary to the patient’s interests.  These disadvantages are compounded when, as in several instances in this case, insufficient consideration is given by the practitioners to the question of whether a mentally-incapacitated patient has consented to or wishes to have the treatment.’

Given his characterisation of E’s performance in court as controlling, manipulative, duplicitous and obstructive it was perhaps not surprising that Mr Justice Baker expressed some sympathy for the long-suffering family GP, Dr W. This ‘older-style family GP’ had been ‘tolerant and sympathetic’ and had maintained a good relationship with the family ‘until he went into the witness box’, when it became clear to E and her husband that, though Dr W had been attentive to the family needs and had responded to her requests to arrange investigations that he did not consider clinically indicated, he did not endorse her wilder theories and diagnoses. Though the parents later expressed ‘disillusionment’ with Dr W, Mr Justice Baker found his evidence ‘responsible, truthful and humane’.

Michael Fitzpatrick

13 October 2014

Michael Fitzpatrick has an autistic son close in age to M; he is a doctor, former GP and the author of MMR and Autism: What Parents Need to Know (2004) and Defeating Autism: A Damaging Delusion (2009)

Brian Deer: Wakefield ‘MMR mother’ fabricated injury story

12 Oct

Brian Deer, the reporter who broke the story on Andrew Wakefield’s conflicts of interests, has a new story on his website:

Wakefield ‘MMR mother’ fabricated injury story
In a newly-released judgment from England’s Court of Protection, a prominent anti-vaccine campaigner is branded a manipulative liar. Brian Deer reports

The story is quite sad. And while it presents an extreme case, there are themes here which have been seen elsewhere.

A British “mother warrior”, who claimed that the combined measles, mumps and rubella vaccine is responsible for autism, fabricated accounts of injury to her son and persistently lied about his health, a London court has ruled.

The mother, “E”, who cannot be named so as to protect her son’s identity, concocted a story about how he reacted to an MMR shot in January 1991. She said that he became distressed with fever and then lost speech, eye contact and play immediately following his three-in-one at the age of 18 months.

She claimed that he screamed after immunization, and that this was followed by six hours of convulsions and vomiting, and then six months in a “persistent vegetative state”.

But in a landmark 45,000-word judgment, which entered the public domain last week from the Court of Protection, the mother was dismissed as a manipulative liar. It was found that she had made up the story so as to bring attention to herself and had plied her developmentally delayed son with a mass of sometimes bizarre “biomedical” interventions so as to gain “total control” over his life.

Mr. Deer’s story goes on (Wakefield ‘MMR mother’ fabricated injury story) with more details. Many more details are in the court’s judgment which is linked to at the end of Mr. Deer’s article. I won’t copy it all here, I encourage you to read it there.

Here’s a paragraph from the judgment that goes to the evolution of the story surrounding the day in which the child received the MMR vaccine. The fact that the allegation of a vaccine reaction was not made until is important as this was 10 years after the event. Also worth noting is that this individual showed developmental issues well before the MMR vaccine.

After the allegation of an adverse reaction to MMR was eventually recorded in 2001, it became more dramatic in subsequent accounts. Thus, in 2001 the description was: “Distressed after injection. Had fever. Eyes glazed, dilated and fixed.” E’s account became more florid over time, with references to screaming, jolting, spasming and a persistent vegetative state. In her final statement she said that: “M died within six hours of the MMR.” In the witness box she gave a full account of the events on the day on which the MMR was administered and M’s reaction to it. E acknowledges in her final statement that she uses certain words and phrases in her own particular way. For example, for her the phrase “vegetative state” means “slipping in and out of consciousness, not responding and appearing lifeless.” And her use of the word “died” to describe what happened to M means “stopped breathing and lost consciousness”

I’d be very interested when “died” became part of the story. Reading the above I was very much reminded of Jenny McCarthy’s statement that her son died from vaccine injury. Ms. McCarthy was referring to her son’s very serious seizures. The timeline has never been made clear, but those seizures appear to have began a year or more after her son’s vaccinations. But her vague choice of words led many to claim that her son “died” shortly after vaccination.

As to “E”‘s experience taking her son to the Royal Free Hospital:

Throughout the hearing, E insisted that M had been given the diagnosis of autistic enterocolitis or leaky gut syndrome and alleged that some of the Royal Free medical records must be missing. I reject that assertion. I find that not even the Royal Free team, who at that time were leading the way and postulating the link between autism and a form of colitis, found any evidence in 2001 of significant gut disorder in M. In his case no diagnosis of autistic enterocolitis or leaky gut syndrome was ever made.

There’s a great deal more, in both Mr. Deer’s story and the 92 page judgment.


By Matt Carey

ABC News covers Brian Hooker’s study: Hooker “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

10 Oct

A recent ABC story (How a Now-Retracted Autism Study Went Viral — Again) discussed Brian Hooker’s flawed and retracted study.  Here are the first few paragraphs:

An autism study that was slammed by experts and retracted this week by its publisher is still alive and well on the Internet, thanks to what critics are calling a perfect storm of lax publishing standards.

Experts say the lone study author played fast and loose with statistics to show a link between autism and the MMR vaccine for measles, mumps and rubella, some experts going as far as saying that the author deliberately did this, but the dubious results took off online anyway, quickly going viral.

“There are always going to be those people at the edges of science who want to shout because they don’t want to believe what the data are showing,” said Dr. Margaret Moon, a pediatrician and bioethicist at Johns Hopkins Berman Institute of Bioethics. She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

“It’s not good. It’s not fair. It’s not honest. But it’s savvy,” Moon said.

Good to see this coming from outside the blogOsphere. Let’s pull one sentence out for emphasis, shall we?

She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

When people ask about data manipulation and the MMR/Autism story, there it is.

The story continues at ABC: How a Now-Retracted Autism Study Went Viral — Again. Included in the story is a CDC statement that I’ve seen before but warrants quoting here.

Centers for Disease Control and Prevention statement regarding Brian Hooker’s reanalysis of its 2004 study Aug. 27, 2014

There was no cover up. The study did not find any statistically significant associations between age at MMR vaccination and autism. In the CDC paper, similar proportions of case (children with autism) and control children (no autism) had been vaccinated before 18 months or before 24 months. While slightly more children with autism (93.4%) than children without autism (90.6%) were vaccinated between 24 and 36 months, this was most likely a result of immunization requirements for preschool special education program attendance in children with autism.

As this topic was so sensitive and complex, the CDC study published in Pediatrics in February 2004 underwent clearance at CDC, the usual process of internal review for scientific accuracy that all CDC papers undergo. In addition, before submission to the journal, the manuscript was reviewed by five experts outside of CDC and an independent CDC statistician (see acknowledgements section of the paper for specific names). Finally, all reputable journals undergo peer-review of all submitted papers before final publication.

The 2004 CDC study was designed as a case-control study. This means, children with autism (cases) were specifically identified, and children without autism (controls) were identified to be similar to the children with autism in other respects. When data are collected in a specific way for a specific type of statistical analysis (a case-control study in this instance), using those data in a different type of analysis can produce confusing results. Because the methods in Dr. Hooker’s reanalysis were not described in detail, it is hard to speculate why his results differed from CDC’s.

Since the 2004 Pediatrics paper, CDC has conducted additional studies of vaccines and autism. In 2004 the Institute of Medicine reviewed published and unpublished findings from the US and other countries and concluded that there was no association between MMR vaccination and autism. In 2011, another IOM committee reviewed additional research, and once again found that evidence favored rejection of this association.


By Matt Carey

Retracted: Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data

5 Oct BadStudyRetracted

About two months ago an autism parent published a study: a “reanalysis” of a CDC dataset. That study: Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data.

Here’s a screenshot of how the article looks online today (click to enlarge):

BadStudyRetracted

The retraction reads:

The Editor and Publisher regretfully retract the article [1] as there were undeclared competing interests on the part of the author which compromised the peer review process. Furthermore, post-publication peer review raised concerns about the validity of the methods and statistical analysis, therefore the Editors no longer have confidence in the soundness of the findings. We apologise to all affected parties for the inconvenience caused.

Previously, the editors had an “expression of concern” about the article:

The Publisher of this article [1] has serious concerns about the validity of its conclusions because of possible undeclared competing interests of the author and peer reviewers. The matter is undergoing investigation. In the meantime, readers are advised to treat the reported conclusions of this study with caution.

Further action will be taken, if appropriate, once our investigation is complete.

Comment on

Brian Hooker. Measles-mumps-rubella vaccination timing and autism among young African American boys: a reanalysis of CDC data. Translational Neurodegeneration 2014, 3:16.

An excellent discussion of this study and the questions raised by it can be found at MMR, the CDC and Brian Hooker: A Guide for Parents and the Media


By Matt Carey

Brian Deer’s original 2004 Channel 4 report on Andrew Wakefield: MMR: What they didn’t tell you

5 Oct Result_of_Wakefields_Scare

When Andrew Wakefield presented his hypothesis linking autism to the MMR vaccine in 2014 1998, he fueled a vaccine scare that is still alive today. It wasn’t until 6 years later that specifics about Mr. Wakefield’s actions were to surface. First in a newspaper story by Brian Deer (Revealed: MMR research scandal). Later that year in a BBC Channel 4 investigation: “MMR What they didn’t tell you.” I’ve never seen that Channel 4 program. Until today. Mr. Deer has placed it on YouTube. In three parts.

Part 1 introduces the topic. The MMR scare, the Wakefield 1998 Lancet paper and the press conference and the Royal Free’s video given out to the press. A discussion with an epidemiologist about the fact that there was nothing in Mr. Wakefield’s own work to support the triple MMR vaccine. Which leads us to the Wakefield patent for a substance that could be used as a vaccine–a vaccine which could only reasonably be expected to make a profit if the existing measles vaccine were considered unsafe–and as an autism “cure”.

Mr. Deer speaks with Ian Bruce, a researcher who worked with Andrew Wakefield on the patent. “The interpretation of that is quite clear to me..and that is that they have a vaccine for measles. Which presumably is an alternative to the existing vaccine.”

The thing is, the public was not told that Mr. Wakefield and the Royal Free had these commercial interests prior to Mr. Deer’s show.

Part 2 discusses the patent–the cure and vaccine aspects. The idea was that measles virus would be injected into a mouse. Those would be extracted, frozen, thawed, mixed with human cells, and injected into pregnant goats. The colostrum (part of the goat’s milk) would then form the basis of this vaccine/cure substance.

Sound like a strange idea to you? Well, Mr. Deer interviews medical experts who also think so. “the whole technique doesn’t make sense”. “It’s not credible”. “It’s strange”.

Mr. Deer tries to interview Dr. Roy Pounder, Mr. Wakefield’s former supervisor at the Royal Free. Mr. Pounder at first agrees then refuses to be interviewed.

Mr. Deer then goes to American and interviews Hugh Fudenberg, collaborator with Mr. Wakefield and co-inventor on the patent. Mr. Fudenberg at the time was charging up to $750 an hour to see and treat autistic children. He too considers Mr. Wakefield’s treatment to be unfounded. However, Mr. Fudenberg had a cure of his own, made from his own bone marrow.

Mr. Deer discusses some of the criticism of Mr. Wakefield’s work, including a statement from someone who worked in the Royal Free Hospital, including a comment that the work amounted to abuse.

Part 3 includes a discussion with Nick Chadwick, a student in Mr. Wakefield’s laboratory during the MMR/Autism research. Mr. Chadwick tested the tissues for measles virus, and found there was none in the autistic children being seen by Mr. Wakefield’s team. Also interviewed was Ian Bruce, a colleague of Mr. Wakefield’s, and also a supervisor for Nick Chadwick. Both Chadwick and Bruce are highly confident that if there were measles virus in the tissues, they would have detected it.

Mr. Deer discusses the 2000 measles outbreak in Ireland. He interviews the parents of one of the children who died in that outbreak. For those who keep saying that measles is mild, that in first world countries no one dies or is injured, here’s what a child dying of measles looks like in the first world. She took 11 months to die.

Result_of_Wakefields_Scare

Mr. Deer then goes to America to find and try to speak with Mr. Wakefield. Mr. Wakefield was listed as “research director” for Jeff Bradstreet’s clinic in Florida, but wasn’t there. The Bradstreet clinic had a host of supplements that one could purchase to “treat” autism. Mr. Deer eventually finds Mr. Wakefield at an Autism Society of America convention. Whereupon Mr. Wakefield runs away.

By the way–Thank you ASA for no longer inviting Andrew Wakefield to speak.

This investigative report together with the Sunday Times articles earlier in 2004 made a huge impact at the time. I know as I lived through it. The retraction of interpretation published by most of Mr. Wakefield’s co-authors on the 1998 Lancet paper (since fully retracted by the journal), was a big statement that this work was not solid. Of course, Brian Deer would eventually go on to win a U.K. Press Award for his MMR journalism and Mr. Wakefield would eventually be found to have been unethical in his research and struck off the register (lose his medical license).

The embedded version below should go through all three parts in sequence.

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