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Andrew Wakefield and Brian Hooker complain. Not honestly, but they complain

23 Oct

Andrew Wakefield and Brian Hooker have lately been trying to manage a “cdc whistleblower” story. The idea has been covered a lot recently, here and elsewhere. So, rather than go into more introduction, let’s take a look at the complaint they recently filed with the CDC office of research integrity. It’s long, so I’ll bring up a few glaring problems with the complaint letter. These problems have for the most part already been discussed here at Left Brain/Right Brain.

The basis of their arguments has been that allegedly the CDC found a statistically significant result suggesting that the MMR was associated with a higher odds ratio for autism in African American boys. They argue that the CDC then changed their protocol (analysis plan) to avoid reporting on this result. Mr. Wakefield and Mr. Hooker have since added a similar argument for “isolated autism”–autism without comorbid conditions like intellectual disability. They claim the CDC hid those results as well.

So, what does the complaint say in specific? It’s long, but here’s an interesting and key part and a good place to start. Under the section titled “The Georgia Birth Certificate Cohort (GBCC): what was its stated purpose?“, Hooker and Wakefield quote the

[Exhibit 2, page 7, emphasis added] The Analysis Plan, “Statistical Analyses” states that “race” data were available for the entire sample:

The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race.

[Exhibit 2, page 8, emphasis added]. Thus, “race” data came explicitly from the “school record” and not from the Georgia birth certificate/Georgia birth
records and was available for the “entire sample”.

The funny thing is that quote, “The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race” doesn’t match what’s in the screenshot of the analysis plan that Wakefield included in his recent YouTube video (click to enlarge).

Draft Plan 2

The plan actually states:

The only variable available to be assessed as a potential confounder using the entire sample is child’s race.

emphasis added.

See how “available to be assessed” in the actual plan has been changed into “that will be assessed” by Mr. Wakefield? Mr. Wakefield would like us to believe that the analysis plan called for a study to be reported broken down by race using all the kids in the study. He’s been arguing that since his first ugly “It’s like the Tuskegee experiment!” video. The thing is that the plan didn’t call for that. As I recently discussed, the sentence Mr. Wakefield misquotes was a statement of the limitations of the dataset they had (MADDSP) and explains why the CDC needed to get the birth certificate data to do a more thorough analysis.

As I also noted, the full paragraph references table included in the analysis plan made it clear that race was to be analyzed for the birth certificate sample, not the total sample as Mr. Wakefield is leading us to believe.  The title of the table shows us that they were planning to report detailed data on the birth certificate group, not the entire sample.

What I find interesting is that Wakefield and Hooker are not just misinterpreting the statement as I originally thought. In the complaint they clearly changed what the statement said. Besides being wrong all on it’s own, this change tells me they know that phrase they latched on to ( “The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race”) doesn’t come close to fitting in with his story. I don’t see this as an honest mistake.

The complaint also includes the “isolated autism” argument Mr. Wakefield recently put into another YouTube video. In this, Mr. Wakefield claims that all sorts of methods were used to hide an association observed for MMR and autism without other conditions like intellectual disability, cerebral palsy, etc.. In his complaint and video, Mr. Wakefield claims one of the methods used to hide this association was by limiting “other conditions” to only “MR” (mental retardation/intellectual disability). In the video Mr Wakefield gives us a fragment of an audio attributed to Mr. Thompson of the CDC saying, “the effect is where you would think it would happen. It is with the kids without other conditions, without the comorbid conditions.”

Mr. Wakefield even went on to say

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, they simply omitted the relevant findings from the paper altogether

Emphasis added.

As I said before, I found this odd in that the CDC did report an apparent association in the raw data. The total sample/unadjusted data. To repeat a quote by Mr. Thompson, “It’s all there!”

Destefano_table_4 highlighted

It’s numerically almost the exact same result as Mr. Wakefield says was concealed. So, if it’s the same, how is it concealed? How is it omitted? Answer: it isn’t.

Remember that quote attributed to William Thompson from the video? Here’s a more full quote that’s from the complaint:

You see that the strongest association is with those [autistic cases] without mental retardation. The non-isolated [sic], the non-MR [mental retardation]…the effect is where you would think it would happen. It is with the kids without other conditions, without the comorbid conditions.

Mr. Wakefield wanted us to believe that by switching to autism without MR instead of autism without MR and/or other disabilities, the CDC were covering up the result.  Not only did the CDC report on the result, this isn’t what Mr. Thompson was saying.  Thompson is not saying, “hey look, we only used MR as a way to conceal the result.” He’s saying, in effect: when we looked at autism without MR, we saw this effect. It looks to me like Thompson is drawing Mr. Hooker’s attention to a result in the paper. Not describing an omitted result hidden from the public.

So, what is it? Did the CDC “simply omit the relevant findings altogether” as Mr. Wakefield stated in his video? No, they didn’t. Don’t take my word for it, take the word of Andrew Wakefield and Brian Hooker. In their complaint they state

2.7. The Group further deviated from the Analysis Plan by limiting the “isolated” group to only those without mental retardation, as published in The Paper.

Emphasis added.

So, we in the autism communities get one story in the video (the result was omitted), but in a legal document he puts the truth (the result was published in the paper).

And, how did the CDC accomplish all this alleged cover up in the story told by Mr. Wakefield and Mr. Hooker? Well, in part the CDC supposedly did this by creating a “revised analysis plan”. From the complaint:

Over the ensuing months and in contravention of the CDC’s own policies,10 they deviated from the Analysis Plan and introduced a “revised analysis plan”11

Wakefield and Hooker can’t provide us with that revised analysis plan. Here is reference 11 noted in the quote above:

11 See original notes of Dr. William Thompson of 9.6.2001: “Get revised analysis plan from Tanya.” Tanya Bashin – a relatively junior member of The Group – was the second author named on the DeStefano 2004 paper. [Exhibit 8] The revised analysis plan itself is not available

I discussed this recently as well. It’s not after “ensuing months” that Mr. Thompson wrote about the “revised” plan. It’s not after the data were analyzed (which the earliest dates given by the complaint are in November).  The comment attributed to Mr. Thompson is dated September 6, 2001, the day after the plan was finalized.

Or, to put it another way: Mr. Wakefield and Mr. Hooker–the revised analysis plan is indeed available. It’s the one you are working from, dated Sept. 5, 2001.

In their complaint, Mr. Hooker and Mr. Wakefield disclose private details about Mr. Thompson which frankly have no real bearing on the complaint and should not have been disclosed.

The complaint is long, but it all hinges on the three major claims: (1) The CDC was supposed to do an analysis of the total group (not just the birth certificate group) by race, (2) that the CDC hid results on “isolated” autism and (3) that they deviated from their analysis plan, introducing a revised plan, to do this.

All three claims are false. And not false as in “I interpret them differently” but false as in “the very data Wakefield and Hooker depend on show them to be fabricated claims”.


By Matt Carey

note– I made significant changes for clarity after this was first put online.

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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

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

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

Harpocrates Speaks on: MMR, the CDC and Brian Hooker: A Guide for Parents and the Media

8 Sep

Todd W. over at Harpocrates Speaks has put together a FAQ like guide on the questions that come up with regards to recent research by Brian Hooker and the allegations Mr. Hooker has made about the CDC. That article is an excellent resource for people looking for some answers on this story. The article starts:

The anti-vaccine community has been in a tizzy lately over a supposed “CDC whistleblower”, Dr. William W. Thompson, who, according to them, revealed fraud at the United States Centers for Disease Control and Prevention (CDC). To bolster their claim, they point to a new study from one of their own, Brian S. Hooker, that purports to show evidence of an increased risk of autism among African American boys who receive their first MMR vaccine late. However, the claims appear to be hollow and unfounded, and so they have chosen to rely on emotional arguments that may sound convincing to those who are not familiar with the issues and people involved. In a truly egregious fashion, they have erroneously and cynically compared this whole thing to the Tuskegee syphilis study, and equated the CDC with Adolf Hitler, Josef Stalin and Pol Pot, combined.

With that in mind, here is a brief FAQ for parents, news media and others to help them understand what the claims are and what the evidence actually says. The questions below have been raised or implied by anti-vaccine activists. Hopefully, this will prevent inaccurate reporting and help parents feel reassured about the MMR vaccine.

That FAQ can be found at MMR, the CDC and Brian Hooker: A Guide for Parents and the Media


By Matt Carey

Online discussions discussing the recent CDC data “reanalysis” story

1 Sep

Educator/writer Liz Ditz often keeps a running summary of online discussions of trending topics. Below are some of her links. They are a few days old, but this gives you a starting place in case you wish to read multiple sources.

Posts discussing Hooker’s allegations, excluding anti-vaccine sources .

Timeline

August 8, 2014: Hooker paper published online

August 18, 2014: Focus Autism Press Release published online

August 18, 2014: Andrew Wakefield’s Autism Media Channel Video Alleging a CDC Whistleblower published online

August 22, 2014: Andrew Wakefield’s Autism Media Channel Video Naming William W. Thompson as “The CDC Whistleblower ” published online

  1. August 22, 2014,  Orac Knows at Respectful Insolence:  Brian Hooker proves Andrew Wakefield wrong about vaccines and autism

    Of course, the key finding in Brian Hooker’s paper is that Wakefield was wrong. Indeed, in this video, Wakefield even admits that he was mostly wrong about MMR and autism. Let that sink in again. He admits that he was mostly wrong about MMR and autism. OK, he says we were “partially right,” but the flip side of that is that he must have been mostly wrong.

  2. August 22, 2014, Reuben Gaines at The Poxes Blog: Andrew Jeremy Wakefield plays video director while African-American Babies die, or something

    Hooker is wrong in his assertions because the DeStefano paper did not leave out African-American children on purpose. Children were excluded from the analysis because of very legitimate and scientific reasons. They either were not the right age, did not have autism but some other neurodevelopment disorder, or were born outside of Georgia. Even if they were tossed into the analysis, DeStefano et al used a statistical analysis that took into account things like birth weight and mother’s age when analysing the data. They wanted to make sure that what they were seeing was most likely because of the MMR vaccine and not because of some other factor associated with autism.

  3. August 23, 2014,  Ren at Epidemiological: Directed Acyclic Graphs and the MMR vaccine doesn’t cause autism.

    I’m very skeptical that Dr. Hooker’s simplified statistical approach can be better than DeStefano et al’s approach of conditional logistic regression. Conditional logistic regression has the advantage of being able to control for a multitude of confounders and effect modifiers.

  4. August 24, 2014, Liz Ditz at I Speak of Dreams: L’affaire CDC-MMR: Hooker, Wakefield, and Focus Autism Accuse African-American Senior CDC Researcher of Being A Race Traitor

    According to Hooker, Wakefield, and Focus Autism, a respected senior African-American physician-researcher is a race traitor and a mass murderer.

  5. August 25, 2014, Orac Knows at Respectful Insolence: The central conspiracy theory of the antivaccine movement 

    I can imagine three main possibilities for what happened. The first possibility from what I know is that Thompson had some sort of disagreement with his co-investigators, made the incredibly stupid—yes, stupid—decision to unburden himself to Brian Hooker, who, he must have known or should have known, is an antivaccine crank associated with Andrew Wakefield, and is now paying the price for that decision… The second possibility is that Thompson wanted to correct something Hooker was doing with the data and somehow let himself be drawn into saying things that could easily be taken out of context. The third, and (I hope) much less likely, possibility is that Thompson’s gone off the deep end and gone antivaccine.

  6. August 25,2014, David Gorski MD at Science Based Medicine: Did a high ranking whistleblower really reveal that the CDC covered up proof that vaccines cause autism in African-American boys?

    “What [Hooker] has done, apparently, is found grist for a perfect conspiracy theory to demonize the CDC, play the race card in a truly despicable fashion, and cast fear, uncertainty, and doubt about the CDC vaccination program, knowing that most of the white antivaccine activists who support hate the CDC so much that they won’t notice that even Hooker’s reanalysis doesn’t support their belief that vaccines caused the autism in their children. Meanwhile, there is no evidence, at least none, submitted by the antivaccine propagandists flogging this conspiracy theory, that there really was a CDC conspiracy to hide anything.

  7. August 25, 2014, ToddW at Harpocrates Speaks, Andrew Wakefield Tortures History

    I want to focus on some statements made by one Andrew Wakefield, the British doctor who committed scientific fraud, resulting in the full retraction of his 1998 case series study on MMR and the stripping of his medical license. Wakefield boldly added himself to the list of not only torturing science, but now adds to his accomplishments torturing history and ethics (granted, we already knew he was ethically challenged). You see, in his videos (here and here) about the alleged “whistleblower”, William Thompson,Wakefield compared the purported “cover-up” to the Tuskegee syphilis debacle. It’s a false comparison used simply to inflame people and claim the race card.

  8. August 25, 2014, Michael Simpson at Skeptical Raptor, Great CDC Coverup–suppressing evidence that MMR vaccines cause autism? cross-posted at at Daily Kos

    It’s clear what’s happening here. Thompson, through sheer ignorance or total incompetence may have had a conversation with Hooker. Given the fact that the antivaccination gang lacks any serious scientific evidence supporting their dogma that vaccines cause autism, they jump on anything, however tenuous, that makes it appear that all of the evidence that refutes their dogma should be thrown in the garbage.

  9. August 26, 2014, Orac Knows at Respectful Insolence: Hey, where is everybody? The “CDC whistleblower” manufactroversy continues apace

    Here it is, Tuesday already, and the antivaccine underground is still on full mental jacket alert over the biggest story the antivaccine movement has seen in a while. Fortunately, it’s a story that’s been largely ignored by the mainstream media, which tells me that maybe, just maybe, the mainstream media has figured out that it shouldn’t give undue credence to cranks.

  10. August 26 2014, Sullivan (Matt Carey) at LeftBrainRightBrain Autism, Atlanta, MMR: serious questions and also how Brian Hooker and Andrew Wakefield are causing damage to the autism communties

    A study relying largely on a small group of subjects (about 20) with the conclusion that more work is needed. Sounds vaguely familiar. And, as we will see, Mr. Hooker has teamed up with Andrew Wakefield to put out a video where they jump past the whole this indicates more research is needed through this is absolute evidence of MMR causing autism directly to the CDC are engaging in a racist experiment sacrificing children to autism. It’s like the events around Mr. Wakefield’s 1997 Lancet paper cranked up to 11.

  11. August 26 2014,Lisa Lightner at Grounded Parents: the CDC vaccines/autism/coverup theory {spoiler alert-it’s not true!}

    a friend, a friend that I consider to be intelligent and reasonable….first posted a link to a CNN article. Correction–it’s iCNN…which is VERY different. ANYONE can post ANYTHING there. You can, really. It’s a crowdsourcing platform. Shame on you CNN for whoring out your name for page views. Because this is what happens–people will post just about anything…..

    I wish we knew the causes of autism, I really do. But vaccines ain’t it.

    Fear sells, don’t buy it.

  12. August 26, 2014, Reuben Gaines at The Poxes Blog: How to end a scientist’s career with some fancy editing

    As much as the anti-vaccine activists have been demanding that Dr. Thompson come out into the open and make some sort of a statement, no one seems to demand that Andrew Jeremy Wakefield and his team publish the entire recorded conversation between Brian Hooker and Dr. Thompson. All we get are lies and innuendo. We have operatives like Ginger Taylor writing on Twitter that CDC deliberately didn’t look at birth certificates for African-American babies in the DeStefano study.

    August 26, 2014: Anti-Vaccine Group The Thinking Mom’s Revolution Hosts a #CDCWhistleblower Twitter Party

  13. August 27, 2014 Karoli Kuns at Crooks and Liars: Rob Schneider’s Anti-Vax Crusade Now Enters Alex Jones Territory

    There’s nothing like a good conspiracy theory to get the creative juices flowing. For actor Rob Schneider, that means getting your dander up over your incorrect belief that the CDC altered data to bury the “fact” that MMR causes autism.

  14. August 27 2014, Sullivan (Matt Carey) at LeftBrainRightBrain Autism: Discussions of the recent MMR/autism paper (and why the study isn’t what the author wants you to believe it is)

    Below are a selected list of discussions about Brian Hooker’s recent paper and the highly irresponsible way he and his team are promoting it. Let me know if you spot one I should add to the list.

  15. August 27, 2014,  Orac Knows at Respectful Insolence: The CDC “whistleblower” manufactroversy: Twitter parties and another “bombshell” e-mail

    … just how desperate the antivaccine movement is to have Brian Hooker’s incompetent “reanalysis” of a ten year old vaccine safety study and Andrew Wakefield’s despicable race-baiting video gain traction in the mainstream media. The failure of this conspiracy theory to do so is driving antivaccine activists into ever-greater fits of lunacy online.

  16. August 27, 2014, Phil Plait at Bad Astronomy, Slate: No, There Still Is No Connection Between Vaccines and Autism

    There’s a conspiracy theory going around that the CDC covered up a link between autism and vaccines. From what I can tell, this conspiracy theory is on the same level as the one that NASA faked the Moon landings. And you know how I feel about that.

  17. August 27, 2014, ToddW at Harpocrates Speaks, Anti-vaccine Activists Throw Twitter Tantrum

    … the hashtag #CDCwhistleblower to do what really amounted to the social media equivalent of a temper tantrum, whining about how the mainstream media is not reporting on the study. It was really a sad display, as they simply all copied and pasted from the same list of talking points, not even adding their own interpretation.

    August 27, 2014, in the morning: The Journal Translational Neurodegeneration removes Hooker’s paper from the public domain

  18. August 27 2014, Sullivan (Matt Carey) at LeftBrainRightBrain Autism:The Brian Hooker article “…has been removed from the public domain because of serious concerns about the validity of its conclusions”
  19. August 27, 2014, Adam Marcus at Retraction Watch: Journal takes down autism-vaccine paper pending investigation

    An article purporting to find that black children are at substantially increased risk for autism after early exposure to the measles-mumps-rubella vaccine has been shelved, amid claims that a CDC whistleblower has accused health officials of suppressing information about the link.

  20. August 27, 2014, Reuben Gaines at The Poxes Blog: Even the bottom-feeding journals seem to have some sense

    ’m still left wondering how this paper got through peer review, or who did the peer review. They seem to not have bothered with checking the biostatistics or with looking back at the DeStefano paper.

    August 27, 2014, at approximately 2:30 pm, PDT, attorneys for William W. Thompson, the CDC employee, publish Thompson’s statement

  21. August 27, 2014: Ren at Epidemiological Dr. Brian S. Hooker gets the Andrew Wakefield treatment.

    My problem with Dr. Thompson’s statement is that the data were not omitted willy-nilly. There was a protocol that was established, and it excluded from the analysis children of different ethnicities, not just African Americans. In that exclusion, a vaccine-autism signal that was confounded by different factors was lost. It wasn’t lost out of bias but out of properly adjusting for different factors.

  22. August 28, 2014, Sullivan at LeftbrainRightBrain Andrew Wakefield betrays another “whistleblower” with Brian Hooker helping

    Apparently Mr. Hooker is unaware that the secrecy of confession is absolute. Priests, real ones, not self appointed ones like Mr. Hooker, have been known to go to jail rather than divulge what they’ve been told in confession. Real priests don’t record confessions so they can betray another.

  23. August 28, 2014, Debra Goldschmidt, CNN, Journal questions validity of autism and vaccine study

    Dr. Frank DeStefano, lead author of the 2004 study, said he and his colleagues stand by their findings. DeStefano said all the study authors, including Thompson, agreed on the analysis and interpretation before the study was submitted for publication 10 years ago. However, he said he plans to review his notes and will decide whether to run another analysis on the data.

  24. August 28, 2014, Reuben Gaines at The Poxes Blog, Autism is not death, unless you want it to be

    While the black ribbon can mean different things to different people, it’s main use is for grieving or remembering the fallen, the dead. The way that these people have used it is to try to bring attention to their cause by equating autism with a death or a loss.

  25. August 28, 2014, Orac at Respectful Insolence A bad day for antivaccinationists: A possible retraction, and the “CDC whistleblower” issues a statement

    Betrayals within betrayals. This can’t all be laid on Wakefield. Thompson was played. Big time.

Posts discussing Hooker’s allegations from anti-vaccine sources and those believing Hooker’s allegations  .

Timeline

August 8, 2014: Hooker paper published online

August 18, 2014: Focus Autism Press Release published online

August 18, 2014: Andrew Wakefield’s Autism Media Channel Video Alleging a CDC Whistleblower published online

  1. August 18, 2014, Jake Crosby at Autism Investigated: CDC Whistleblower Reveals Yet More Research Fraud
  2. August 19, 2014 Age of Autism at Age of Autism: Whistleblower Says CDC Knew in 2003 of Higher Autism Rate Among African-American Boys Receiving MMR Shot Earlier Than 36 Months
  3. August 20, 2014, Mike Adams at Natural News: Vaccine bombshell: CDC whistleblower reveals cover-up linking MMR vaccines to autism in African-Americans
  4. August 20, 2014, Age of Autism at Age of Autism: Senior Government Scientist Breaks 13 Years’ Silence on CDC’s Vaccine-autism Fraud
  5. August 20, 2014 Jon Rappoport at Jon Rappoport’s Blog Breaking: Breaking: MMR vaccine, autism, CDC coverup 
  6. August 21, 2014 Jon Rappoport at Jon Rappoport’s Blog: Vaccine-autism connection: US Congressman stonewalled by the CDC
  7. August 21, 2014 Jon Rappoport at Jon Rappoport’s Blog: Advice for the secret CDC vaccine whistleblower
  8. August 21, 2014: Mike Adams at Natural News:  CDC refuses to turn over documents to Congress: Evidence linking MMR vaccines to autism intentionally withheld from investigators
  9. August 22, 2014, Ethan Huff at Natural News, CDC whistleblower confesses to publishing fraudulent data to obfuscate link between vaccines and autism
  10. August 22, 2014, metamars at My Firedog Lake: CDC refuses to turn over documents to Congress showing MMR vaccines caused autism in black children (note: metamars’ blog post, not an official Firedoglake post)

    August 22, 2014: Andrew Wakefield’s Autism Media Channel Video Naming William W. Thompson as “The CDC Whistleblower ” published online

  11. August 22, 2014 Jon Rappoport at Jon Rappoport’s Blog: CDC whistleblower revealed: William Thompson
  12. August 22, 2014 Jon Rappoport at Jon Rappoport’s Blog: What CDC whistleblower William Thompson needs to do now
  13. August 22, 2014 Jon Rappaport at Jon Rappaport’s Blog Breaking: CDC whistleblower Thompson in grave danger now
  14. August 22, 2014, at TMR at Thinking Moms’ Revolution: CDC Whistleblower William Thompson Blows the Lid on Malfeasance and Fraud at the CDC
  15. August 22, 2014, Jake Crosby at Autism Investigated, Andrew Wakefield Betrays CDC Whistleblower
  16. August 23, 2014, Inquisitr CDC Whistleblower’s Claims Cause Uproar In Autism Community
  17. August 24, 2014 Jon Rappoport at Jon Rappoport’s Blog CNN iReport on CDC whistleblower spreads like wildfire, then censored
  18. August 24, 2014, Jon Rappaport at Jon Rappaport’s Blog Rob Schneider says he has smoking gun on CDC vaccine-autism fraud  (For beginners: Rob Schneider is an actor who has in the last few years become an anti-vaccine activist. Why he would have access to sensitive information is an open question.)
  19. August 24, 2014, Sally Colletti, Examiner:  Autism and The CDC: Now What?
  20. August 25, 2014, Kent Heckenlively, Age of Autism: A Break in the Wall – William W. Thompson
  21. August 25, 2014, Ethan Huff at Natural News: CDC whistleblower exposes massive autism cover-up perpetrated by government agency
  22. August 25, 2014, Mike Adams at Natural News: CDC whistleblower’s secret letter to Gerberding released by Natural News as mainstream media desperately censors explosive story
  23. August 25, 2014, Mike Adams at Natural News CNN caught red handed covering up CDC medical genocide of African-American babies (much handwaving over open-source reports at iCNN being changed or deleted.)
  24. August 25, 2014, Zorro at Thinking Moms’ Revolution: Stop Calling Us Crazy: Autism, MMR, and Institutional Gaslighting
  25. August 25, 2014, Megan Heimer at Living Whole CDC Whistleblower Comes Out and They All Play Dead
  26. August 25, 2014, Age of Autism at Age of Autism: Rob Schneider Demands Answers on CDC MMR Fraud
  27. August 25, 2014, Jon Rappoport at Jon Rappoport’s Blog CDC vaccine-autism fraud: what victory looks like
  28. August 25, 2014, Jon Rappoport at Activist Post: CDC whistleblower, watch out; here come the mothers
  29. August 25, 2014, Kelly Brogan at Kelly Brogan MD CDC: You’re Fired. Autism Coverup Exposed.
  30. August 25, 2014, Patrick “Tim” Bolen at the Bolen Report The CDC Whistleblower… The Story Mainstream Media Doesn’t Want To Run…
  31. August 26, 2014, JB Handley at Age of Autism: Knock-out Blow Needed: Dr. Thompson Must Speak Out on MMR African American Autism Connection.
  32. August 26, 2014, John Stone at Age of Autism:CDC Frauds: Connections Between the DeStefano Paper and the Thorsen Affair.
  33. August 26, 2014, Celia Farber, Epoch Times:  Whistleblower Reveals CDC Knowingly Put Children at Risk of Autism, Media Remains Silent (Video)
  34. August 26, 2014, Jon Rappoport at Jon Rappoport’s Blog CDC whistleblower is just the tip of the iceberg
  35. August 26, 2014 Mike Adams at Natural News EXCLUSIVE: Bombshell email from CDC whistleblower reveals criminality of vaccine cover-up as far back as 2002
  36. August 26, 2014, Age of Autism at Age of Autism: CDC Whistleblower on Thimerosal in Pregnant Women (note: video interview with Brian Hooker, not William W. Thompson)

    August 26, 2014, in the evening: Anti-vaccine Activists at The Thinking Moms’ Revolution Host a #CDCWhistleblower Twitter Party

  37. August 27, 2014, “Bobby Dee” at Gianelloni Family: Erased by a Birth Certificate
  38. August 27, 2014, John Stone, Age of Autism: The CDC: the Detective Agency Which Could Never Find Anything<
  39. August 27, 2014, Anne Dachel, Age of Autism: CDC Whistleblower Story: Danke to Franchi
  40. August 27, 2014, Marcella Piper-Terry, CDC Whistleblower and Probability of Post-MMR Autism Diagnosis
  41. August 27, 2014, Marcella Piper-Terry at Thinking Mom’s Revolution How Many African-American Boys Have Autism as a Result of the CDC’s Lies?
  42. August 27, 2014, Ethan Huff at Natural News: Congressman Posey discusses autism, vaccines and lack of CDC transparency in interview with Dr. Brian Hooker
  43. August 27, 2014 Mike Adams at Natural News: Media conspiracy to bury CDC whistleblower story protects vaccine makers at the expense of human life
  44. August 27, 2014, Jon Rappoport at Jon Rappoport’s Blog Update: CDC whistleblower in touch with members of Congress

    August 27, 2014, in the morning: The Journal Translational Neurodegeneration removes Hooker’s paper from the public domain

  45. August 27, 2014 Mike Adams at Natural News: Scientific journal censors Brian Hooker’s analysis of CDC vaccine data; the Church of Science orders ‘burning of books’
  46. August 27, 2014, Age of Autism at Age of Autism: Translational Neurodegeneration Removes Vaccination Timing Article

    August 27, 2014, at approximately 2:30 pm, PDT, attorneys for William W. Thompson, the CDC employee, publish Thompson’s statement

  47. August 27, 2014, Age of Autism at Age of Autism: Statement from William Thompson, RE Pediatrics MMR African American Males Data
  48. August 27, 2014 Mike Adams at Natural News: BREAKING: CDC whistleblower confesses to MMR vaccine research fraud in historic public statement
  49. August 27, 2014, The Event Chronicle at The Event Chronicle: CDC whistleblower confesses to MMR vaccine research fraud in historic public statement
  50. August 28, 2014 Celia Farber, Epoch Times Vaccinegate: CDC Whistleblower Admits Claims of Data Fixing Were True, Complains at Being Recorded and Outed

Other links