CDC whistleblower

Take It from an Anti-Vaxxer – There Is No CDC Whistleblower Scandal

The CDC whistleblower scandal which erupted in 2014 is about a supposed cover-up of data linking MMR vaccines to autism. However, leaked documents tell a different story. In this story, actions almost certainly done in good faith are misconstrued as fraud. This distorted interpretation then gets repeated, is never verified, and soon becomes taken as fact. Productive arguments as to why vaccines cause autism are then drowned out by cries of conspiracy. Instead of making progress, the anti-vaccine community then suffers backfire from rallying behind a poor argument.

The real reason the research community is wrong about MMR not causing autism has nothing to do with a conspiracy, but rather a systematic flaw called “healthy user bias” (HUB), which conceals the true harms of vaccines. It’s time for the anti-vaccine community to ditch harmful conspiracy theories and to take up discussion of actual methodological flaws.

Timeline of Events In the CDC Whistleblower Scandal

Before we analyze whether accusations of a cover-up are true, let’s review the timeline of events that led to this controversy.

The 2004 MMR-Autism Study

The story starts with a CDC researcher named William Thompson who was involved in a study published in 2004 (DeStefano et al.) that examined whether or not the age at which a child gets MMR vaccination has any association with autism.1 The authors did some unadjusted analyes on an overall sample, and then more adjusted analyses on a smaller sample of just children for whom they had more detailed birth certificate information. They found that autistic and nonautistic children were about equaly likely to be vaccinated before or around 18 months of age. However, in the unadjusted analyses autistic children (specifically boys) were more likely to be vaccinated before 36 months of age, especially among children who were 3 to 5 years old. The authors concluded this was likely due to immunization requirements that were enacted around that time. Autistic children in the study needed to be vaccinated in order to attend early intervention or special education programs.

DeStefano et al Table 3

DeStefano et al. 2004. A “statistically significant” association is one where the 95% confidence interval falls entirely above (or below) one. Note the two highlighted significant results in the unadjusted analyses. Note that they are no longer significant in the adjusted analysis.

Thompson Talks With Hooker

Thompson got in touch with a man named Brian Hooker in 2013 and 2014. He also got in touch with Congressman Posey. Andrew Wakefield also somehow got involved. Somehow or the other Hooker and Wakefield got the message that Thompson was accusing the CDC of fraud, and that they had buried a statistically significant result that should have been reported, according to the researchers’ predefined study protocol.

Hooker Publishes A Reanalysis

In 2014 Hooker went on to publish a reanalysis of the same dataset used in the original 2004 study.2 He found an autism risk only in African American males who were vaccinated not on schedule, but before the age of 3. The paper was soon retracted.

Hooker 2014

Hooker. 2014. Significant associations reported in African American males.

Hooker and Wakefield Make Accusations

Thompson kept documents relating to the 2004 study. Sharing some or all of them with Hooker and Wakefield, the latter two began to make public claims that the documents provided evidence of fraud. Pretty much all of their claims are outlined in two complaint letters they jointly sent to the CDC office of research integrity.3,4 Hooker also published his own statement much later in 2016.5 Though the two made many claims, it will suffice to review what we identify as seven of the most important ones:

  1. That the researchers’ explanation that the vaccine-autism association they reported is likely explained by immunization requirements is not founded.
  2. That the above explanation is so poor that it suggests deliberate misdirection.
  3. That the researchers planned to do analysis by race in the overall sample.
  4. That the above analysis found an assocation between MMR and autism in African Americans.
  5. That the researchers then chose to deviate from the protocol and omit this association from publication.
  6. That the researchers then changed the protocol to introduce a birth certificate requirement, which they knew would comprise a sample less likely turn up a race effect.
  7. That the researchers held a secret meeting to destroy documents relating to the study in order to cover their tracks.

Vaxxed Documentary Popularizes the Controversy

Wakefield directed a documentary called Vaxxed which presented the narrative of a cover-up at the CDC pertaining to the 2004 DeStefano et al. study.6 This resulted in widespread awareness of what has been dubbed the “CDC whistleblower” scandal.

The Documents Are Released Publicly

Thompson also passed his documents onto Congressman Posey for some reason or the other, perhaps hoping to get a chance to testify before Congress. Posey’s office has shared the documents with at least a couple of other people or groups. One such group is Matt Carey and Dorit Reiss, who are both autism activists (who don’t believe vaccines cause autism). Carey is the present author of the website Left Brain Right Brain. He has the entire cache of documents available as a zip file on the site.7 The most salient screenshots from the documents are also worked into his articles. Wakefield has also provided a copy of the documents on the Vaxxed documentary website.8 In both cases, these websites seem to have made the documents available in early 2016.

Fact Checking the Accusations

That pretty much finishes the timeline of the most pertinent events. Now the question is whether or not any of Hooker and Wakefield’s claims are true? Answering these questions obviously requires knowing what Thompson’s documents contain. Unfortunately, the entire internet has been content to just assume they pointed to a conspiracy, without actually checking them.

If you were to look at any epidemiological study whatsoever with the kind of lens that Hooker and Wakefield are applying, it is likely you would be able to find actions that can be considered suspicious, or at least biased. This is why it’s important that people are given the benefit of the doubt. We should ask ourselves what kind of society we would like to live in if false accusations were made against us. While some actions taken by DeStefano et al. could be interpreted as being questionable, this does not automatically translate into intentional misconduct. Hence, in such instances, it is important we assume they acted in good faith. With this in mind, and with the help of the documents, let’s go through the accusations:

Claim #1: Immunization requirements do not explain the reported vaccine-autism association.

Hooker and Wakefield make various arguments as to why the reported significant result in the unadjusted analyses is not spurious, as DeStefano et al. suggest.4 Some of their arguments may be reasonable. For example, Hooker and Wakefield argue that if immunization requirements are the explanation of the reported association, why are boys and girls not affected equally? It’s a valid question. On the other hand, it would be hard to come up with a biological explanation as to why it is more dangerous for boys to receive MMR at a later age than at an earlier age (where no significant association was reported). So there may be valid arguments on both sides. In any case, the researchers only state in the abstract that the immunization requirements “likely” explain the association. That is not a definitive dismissal of other possible interpretations. So for this claim, we conclude that Hooker and Wakefield might actually have a point.

Claim #2: That the above immunization requirements explanation is so poor that it suggests deliberate misdirection.

Taking a leaning towards a “good faith” appraisal, the aforementioned criticisms made by Hooker and Wakefield can potentially be explained as an understandable disagreement in the interpretation of data. Hence, no scientific misconduct has yet been demonstrated.

Claim #3: Race analysis was planned for the overall sample.

The released documents contain drafts of the researchers analysis plans (a.k.a the study protocol). There is nothing in them that definitively indicates that any race analysis was ever intended in the overall sample. The closest thing that can be construed as such is a statement in the finalized plan (dated September 5, 2001) saying:

“The only variable available to be assessed as a potential confounder using the entire sample is child’s race.”9

Though that does arguably sound like a race analysis was planned, from the larger context of where that quotation appears, it is most sensible to interpret this statement as merely describing the fact that the data they have available to analyze is limited, and hence separate analysis of just those with birth certificate data (which provides more information) is needed. But Wakefield and Hooker have misquoted this line in the complaint they sent to the CDC office of research integrity, writing:

“The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race.”3 [Emphasis added]

It is possible that Hooker and Wakefield just made a mistake here, as opposed to intentionally misrepresenting what was stated in the analysis plan. Though it is also arguable that it was intentional…

Claim #4: An analysis in the overall sample found an association between MMR and autism in African Americans.

Thompson posted a statement on his lawyers’ website in 2014. It in part read:

“I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.”10

There is no need to doubt the truthfulness that such a statistically significant association was indeed found and not reported. But that does not mean the association was correct, or that it was misconduct to omit it. Thompson himself wrote in a statement to Congressman Posey:

“The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation.”11

Claim #5: The researchers deviated from the study protocol by not publishing this association.

As already discussed, the analysis plan never clearly stated that a race analysis was planned in the overall sample. Yet based on Thompson’s statement, it seems he believes that it was. A likely explanation here is that Thompson is simply mistaken about what was agreed upon by the team of researchers. Sometimes gaps in communications happen when you are working in teams. We have to give the benefit of the doubt to the researchers here, as the written analysis plan does not definitively support Thompson’s claim that the study protocol was not followed. It is likely that the researchers found the race association in the overall sample and decided it made the most sense not to report it. And there are valid reasons why epidemiologists would do such a thing in a variety of contexts if they believe the data is unreliable, and if no predefined protocol called for it to be reported. It is common in epidemiological studies to perform both unadjusted and adjusted analyses. And of these two, you really only tend to believe the results of the adjusted analyses.

In retrospect, it would have been wiser had the researchers reported the significant finding, as that would have given the public the opportunity to scrutinize the association, and determine for themselves that it was not reliable. Having failed to do this, room for doubt was created, which has allowed a conspiracy theory to develop. So it is likely that the researchers decision to omit this statistically significant finding was on one hand foolish, but on the other hand innocent.

Claim #6: The researchers introduced a birth certificate requirement in order to conceal the race effect.

Screenshots of even the earliest draft of the analysis plan (dated April 3, 2001) show that the plan stated:

“For the children born in Georgia for whom we have a birth certificate, we will perform several sub-analyses similar to the main analyses, and will include several additional potentially confounding variables.”7

Seeing as the birth certificate analysis was always planned from the beginning, this accusation is certainly false. So Hooker and Wakefield were wrong. Hopefully this error was not intentional, though it does look suspect…

Claim # 7: The researchers held a meeting to destroy documents relating to the study in order to cover their tracks.

Thompson says that the researchers scheduled a meeting in 2002 and got together to destroy documents relating to the study. He stated:

“At the bottom of Table 7 it also shows that for the non-birth certificate sample, the adjusted race effect statistical significance was huge. All the authors and I met and decided sometime between August and September ’02 not to report any race effects for the paper. Sometime soon after the meeting, we decided to exclude reporting any race effects, the co-authors scheduled a meeting to destroy documents related to the study. The remaining four co-authors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can. However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hard copies of all documents in my office and I retained all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.”12

There are some problems with the claim that trashing documents was part of a cover-up.12  Firstly, the year is 2002. The CDC has digital copies of everything. And secondly, it is only a requirement to keep enough records so that the study can be recreated from scratch. And we know the CDC met these requirements because Hooker himself performed his reanalysis based on data he got from the CDC directly. The data is potentially available to any researcher who requests it from the CDC.13 In other words, throwing out unneeded documents could have easily just been housekeeping. Carey points out that most of the 1,000 pages provided to him by Congressman Posey are uninteresting and could easily stand to be discarded.11

So in short, none of Hooker and Wakefield’s claims are convincing.

Everyone’s Missing the Bigger Picture

There are several other angles to this controversy. For example, why was Hooker’s reanalysis retracted? The journal’s official retraction notice states undisclosed conflicts of interest and concerns over the validity of the methodology.2 Whether or not those concerns are correct, and whether or not a subsequent retraction was in keeping with the journal’s stated retraction policies have been debated.14,15 Endless detail could go into discussing this and a number of other issues.

But the thing is, it doesn’t really matter. Everyone is missing the bigger picture. Something like 1 in 59 children in the USA may have autism.16 However much one may debate the accuracy of that estimate, the true number is still going to be a lot. And you can bet most of them are not black. Even in the worst case scenario that some kind of cover-up did happen (which is extremely unlikely), this would not be able to explain why numerous studies done all around the world have not found an association between MMR and autism. Yes, some MMR-autism studies have concerning reported conflicts of interest17, but some do not. Smeeth et al. for example report no conflicts of interest, and yet they did not find an association between MMR and autism.18 An isolated alleged cover-up simply cannot explain results like this.

Conspiracy Theories Versus Systematic Bias

So the anti-vaccine community needs to ask itself: Are vaccines a primary culprit in the autism epidemic? Or are they not? If they are, then positing a cover-up of an autism risk in just blacks would in no way explain why vaccines are causing autism in everyone else. That leaves a person with three choices:

  1. Accept the many MMR-autism studies as being correct, and abandon the MMR-autism hypothesis.
  2. Posit that corruption is pervasive and that every single MMR-autism study is tainted.
  3. Posit that there is a systematic bias that similarly affects all MMR-autism studies, causing them to give wrong results.

The correct choice is number three. It doesn’t require widespread corruption for the research community to be chronically wrong. It merely requires just one mistake made repeatedly. Suppose ten people are looking through a glass window that is tinted green. They see the white wall of a building across the street and are asked to report what color the wall is. Every one of them may say that it is green. There would be a consensus and so they would likely conclude that the wall is green. Of course, they are all wrong because none of them realize that the window is tinted, distorting their perceptions.

Healthy User Bias (HUB) – The Real Reason All MMR-Autism Studies Are Wrong

Healthy user bias (HUB) is the systematic bias that explains it all. We’ve gone into this in great detail. If you truly want to understand the issue of HUB in depth, then read that article. But here is the abridged version:

  1. Parents notice signs of autism in their children.
  2. Such parents are particularly afraid that vaccines are unsafe for their children.
  3. Such parents are therefore likely to not allow their autistic children to receive the MMR vaccine.
  4. Autistic children are therefore concentrated in the control groups of MMR-autism studies.

This is not an unsubstantiated theory. It is a documented fact that autistic children avoid MMR vaccination far more frequently than nonautistic children. In other words, the reason MMR is not positively associated with autism in any study is not because MMR doesn’t cause autism, but because autism causes avoidance of MMR! Researchers have the whole thing backwards. The below picture summarizes this bias:

The reason MMR is not associated with autism is because autistic children are highly likely to not get MMR in the first place.

So what kind of results would MMR-autism studies have if HUB was properly accounted for? We go through some rough calculations that answer this question in another article.
[ARTICLE IN PROGRESS…CHECK BACK LATER]
The answer is not pretty, and suggests that MMR does in fact cause autism. The research community has been wrong all along. And it has nothing to do with a cover-up.

Calling People Shills Makes the Rest of Us Look Stupid

True, vaccine promoters can be cruel and ignorant. But so can vaccine skeptics. The fact of the matter is, there is no convincing evidence of a cover-up. Yet unfortunately, anywhere this CDC whistleblower scandal is doubted, the comments are sure to be flooded with accusations of people being shills for Big Pharma. Aside from being obnoxious, it makes the rest of us look stupid. The result is that important issues like healthy user bias get drowned out by the noise. Just ask yourself, how many people have even heard about healthy user bias in MMR-autism studies? The answer is very few.

Anti-vaccine community, I am definitely on your side. But it’s time to wake up. Constantly playing the corruption card doesn’t help move things forward. It’s time to let go of Hooker, Wakefield, Thompson, and the alleged CDC scandal, and start talking about healthy user bias. That actually has the potential to turn the tide. Bad arguments can never be effective in changing vaccine policy or the direction of research. Only good arguments can.

Conclusion – We’ve Been Duped… By Ourselves

Hooker and Wakefield have construed the 2004 DeStefano et al. study in ways that are demonstrably false. How this happened is debatable. Did they just not read the documents well? Did they intentionally misrepresent them? Have their own personal histories of being painfully marginalized affected their judgement? Whatever the case may be, it doesn’t really matter. The bigger issue is that we all allowed ourselves to believe a story without scrutiny, and without realizing that – even if true – it would not at all change the bigger picture. On the other hand, healthy user bias does change the bigger picture.

1.
DeStefano F, Bhasin T, Thompson W, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta. Pediatrics. 2004;113(2):259-266. [PubMed]
2.
Hooker BS. Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data. T. 2014;3(1):16. doi:10.1186/2047-9158-3-16
3.
Hooker B, Wakefield A, Moody J. Official Complaint Letter to the CDC 10/14/2014 Re: Alleged Research Misconduct – falsification by omission of material results in the publication of: “Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-Matched Control Subjects: A PopulationBased Study in Metropolitan Atlanta. Pediatrics, 2004;113:259-266 [The Paper; Exhibit 1]. VAXXED. http://vaxxedthemovie.com/official-complaint-letter-to-the-CDC-10-14-2014.pdf. Published October 14, 2014. Accessed June 1, 2018.
4.
Hooker B, Wakefield A. Official Complaint Letter to the CDC 2/02/2015 Re: Alleged Research Misconduct – falsification by omission of material results in the publication of: “Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-Matched Control Subjects: A PopulationBased Study in Metropolitan Atlanta. 2004;113:259-266 [The Paper; Exhibit 1]. Vaxxed. http://vaxxedthemovie.com/official-complaint-letter-to-the-CDC-2-2-2015.pdf. Published February 2, 2015. Accessed June 1, 2018.
5.
Hooker B. Dr. Brian Hooker’s official statement regarding William Thompson. Focus for Health. https://www.focusforhealth.org/dr-brian-hooker-statement-william-thompson/. Published April 26, 2016. Accessed June 1, 2018.
6.
Vaxxed: From Cover-Up to Catastrophe Official Website. Vaxxed. http://vaxxedthemovie.com/. Published April 1, 2016. Accessed June 1, 2018.
7.
The William Thompson Documents. There’s no whistle to blow. Left Brain Right Brain. https://leftbrainrightbrain.co.uk/2016/01/04/the-william-thompson-documents-theres-no-whistle-to-blow/. Published January 4, 2016. Accessed June 1, 2018.
8.
Download The CDC Autism/MMR Files Released By Dr. William Thompson – Vaxxed. Vaxxed. http://vaxxedthemovie.com/download-the-cdc-autism-mmr-files-released-by-dr-william-thompson/. Published August 26, 2016. Accessed June 1, 2018.
9.
Andrew Wakefield and Brian Hooker complain.  Not honestly, but they complain. Left Brain Right Brain. https://leftbrainrightbrain.co.uk/2014/10/23/andrew-wakefield-and-brian-hooker-complain-not-honestly-but-they-complain/. Published October 23, 2014. Accessed June 1, 2018.
10.
Statement of William W. Thompson, Ph.D., Regarding the 2004 Article Examining the Possibility of a Relationship Between MMR Vaccine and Autism – Vaxxed. Vaxxed. http://vaxxedthemovie.com/statement-william-w-thompson-ph-d-regarding-2004-article-examining-possibility-relationship-mmr-vaccine-autism/. Published May 10, 2016. Accessed June 1, 2018.
11.
A look back at the so called “CDC Whistleblower” story and how Vaxxed is misleading. Left Brain Right Brain. https://leftbrainrightbrain.co.uk/2017/02/10/a-look-back-at-the-so-called-cdc-whistleblower-story-and-how-vaxxed-is-misleading/. Published February 10, 2017. Accessed June 1, 2018.
12.
Willingham E. A Congressman, A CDC Whisteblower And An Autism Tempest In A Trashcan. Forbes. https://www.forbes.com/sites/emilywillingham/2015/08/06/a-congressman-a-cdc-whisteblower-and-an-autism-tempest-in-a-trashcan/#533e04c85396. Published August 6, 2015. Accessed June 1, 2018.
13.
CDC Statement Regarding 2004 Pediatrics Article, “Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-matched Control Subjects: A Population-Based Study in Metropolitan Atlanta.” Centers for Disease Control and Prevention. https://www.cdc.gov/vaccinesafety/concerns/autism/cdc2004pediatrics.html. Published December 7, 2015. Accessed June 1, 2018.
14.
Crosby J. Brian Hooker’s Findings Are Confirmed By CDC’s Results. Autism Investigated. http://www.autisminvestigated.com/brian-hooker-confirmed-by-cdc/. Published October 10, 2014. Accessed June 1, 2018.
15.
Directed Acyclic Graphs and the MMR vaccine doesn’t cause autism. Epidemiological. https://epidemiological.net/2014/08/24/directed-acyclic-graphs-and-the-mmr-vaccine-doesnt-cause-autism/. Published August 24, 2014. Accessed June 1, 2018.
16.
Baio J. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years … Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/67/ss/ss6706a1.htm?s_cid=ss6706a1_w. Published May 17, 2018. Accessed June 1, 2018.
17.
Hooker B. Vaccine Science is Not Settled: A Critical Review of the Literature. The Alliance for Natural Health. http://www.anh-usa.org/vaccine-science-is-not-settled-a-critical-review-of-the-literature/. Published December 2, 2016. Accessed June 1, 2018.
18.
Smeeth L, Cook C, Fombonne E, et al. MMR vaccination and pervasive developmental disorders: a case-control study. Lancet. 2004;364(9438):963-969. [PubMed]
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