42 C.F.R. § 93.103: “Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. . . . (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results that the research is not accurately represented in the research record.”
Over the last few days, I have attempted to reason with a few people who, like me, are Pro-Vaccine, but who, unlike me, appear unwilling to accept CDC scientist Dr. William Thompson’s own representation of misdeeds conducted by himself and other senior scientists at the CDC during the early- to mid- 2000’s in their conduct of Vaccine Safety Research studies. The studies conducted and under question by Dr. Thompson’s revelations form the basis of the public’s consensus understanding that “vaccines do not cause autism”. The full text of the transcripts of the conversations between Dr. Thompson and Dr. Brian Hooker are available in the book “Vaccine Whistleblower” by Kevin Barry (Skyhorse Publishing).
For those who do not know yet, I am, will remain, steadfastly in support of vaccines as a proven way to protect the public from the scourges of infectious diseases. That is, I am 100% Pro-Vaccine. However, the evidence that Dr. Brian Hooker managed to obtain from the CDC from the Freedom of Information Act, and from Dr. Thompson during four recorded phone conversations, is, to a person with decades of experience in multivariate statistics and the conduct of complex data analysis in biomedical studies, stunning.
Dr. Thompson made it clear that he and others at the CDC omitted results from a study (DeStefano et al., 2004) showing a positive association between the MMR vaccine and autism in African American male babies. He confirmed these allegations in a message via his lawyer. You can read the statement here. In his recorded conversations with Hooker, Thompson speaks of repeated instances of alleged data cooking, results shopping, repeated analysis, going “off protocol” – a big No-No in biomedical studies – the lack of any external review board over these studies.
He also made it clear in his conversations with Dr. Brian Hooker that the team omitted results showing strong association of autism with vaccination in so-called “Isolated autism”: instance of autism that had no other complicating factor such as comorbid medical conditions or mental disabilities.
During the course of this “internet debates”, the resistance to appeals to logic and reason was incredible – every trick in the book used to attempt to undermine my message, which is simple, and rational:
Given Dr. Thompson’s allegations, there is reason to be concerned that our fundamental understanding of the safety of certain vaccines may no longer be considered secured by those published studies from CDC scientists under question. (Said the Pro-Vaccine scientist/parent). The credibility of the allegations are intensified in that Dr. Thompson is actually admitting that he committed scientific misconduct.
If a whistleblower from any other organization came forward and alleged fraudulent research practices, especially to the extent made public in Thompson’s revelations, heads would roll.
During the internet debate, I clearly identified myself as Pro-vaccine – I pointed out that both of my sons are fully vaccinated, and that, as an expert in bioinformatics and biostatistics, I have grave concerns due to Thompson’s allegations.
I pointed out that I was pro-vaccine, I just want the vaccine safety research to be scrutinized, and, if necessary, redone. If the CDC vaccine safety research team committed scientific misconduct on vaccine safety trials, the pressing question is :
How many, and which vaccines on the pediatric schedule are, in fact, safe?
The tactics used to minimize and dismiss my position by this particular contingent of perhaps well-meaning Pro-Vaccination people are particular ad-hominem, have thus far included:
- Stating that, in spite of what I say, I am against vaccines (again, 100% Pro-Vaccine here, sorry.)
- Claiming that I must be some sort of Creationist (Evolutionary Biologist here).
- That I don’t know the difference between a control variable and a co-factor (I do, I just also happen to know that the use of multicollinear variables in adjusting for variables that are likely have an effect on the main effect while ignoring interaction terms would not pass muster in any serious peer-review. The specific example is the use of age of mother, income of mother, birthweight of baby and gestational age – all very likely highly correlated – and some of which may function to add risk to any toxin. Thus, using statistical control for these variables in vaccine safety studies is a bad idea. The fact that they were used to make a preliminary finding of association of a vaccine with autism disappear – as revealed by an email from one frustrated scientist, Verstraeten, entitled “It Just Won’t Go Away”, well, that just stinks to high heaven. Especially if he pleads with colleagues to please consider the result in the name of objective science, and states that he does not wish to appear to belong the anti-vaccination camp.
- That I had not read the book from which I pulled direct quotes (I had).
- After questioning my credentials, I wrote about my expertise and was told that putting my resume before my “deeds” was pathetic (note how they attack, and then criticize the defense?).
- Calling me a “troll”.
- Claiming I think autism is a game.
- After continued attacks on my character, I offered them a more salient slam: why not just claim that I drown puppies? Because my character has so much more to do with Dr. Thompson’s revelations than Dr. Thompson’s revelations.
- That I had no position discussing the cost of autism to families and society unless I personally had a child with autism (I do not). I’m sure that if I had such a child, however, the criticism would have been belittled for having one, that I clearly have muddied thinking and cannot possible use rationale thought as I would be considered love-sick for the child I lost to regressive autism. I reminded the moderator that I would never tell anyone that they could not discuss the cost of cancer unless they, like me, had lost their mother when they were five years ago to breast cancer.
- In extremely poor taste, Brian Deer dared to call into question Dr. Thompson’s reliability as a witness to wrongdoings that Thompson himself took part in – due to Thompson self reporting what Deer called “some sort of break-down”, which Thompson did reveal during his conversations with Hooker. Deer also attempted to minimize Thompson’s revelations as standard work-place griping. Get and read the book. It’s much, much more than that. Thompson provides highly detailed accounts of wrongdoing. He calls his doings “The lowest point of his career”. He says his supervisor told him to lie. I reminded Deer, an award-winning journalist of the bad judgement in his attempt to use of Thompson’s mental health information as if to minimize Thompson’s revelations. To me, anyone with an ethical core would have had to come to an emotional loggerhead due to the conflict between the knowledge that he was participating in fake science, and the ill effects the vaccines would eventually have on millions of children. I said as much, but the moderator left that comment out. Have some empathy, Deer, and moderator.
- The contingent in question tried repeatedly (but failed) to tie me to Age of Autism, Andrew Wakefield, Brian Hooker, as if any association with them would prove that somehow I was no longer capable of rational, logical thought. No disrespect meant (on my part) to any of the people at Age of Autism, or to Andrew Wakefield, or to Dr. Hooker., or to anyone for that matter.
- Calling me a liar.
What started all of this? I merely shared a published study that reported association between Hep-B vaccine and autism. The moderator claimed in admonishments to discussants that “reported” instances of autism were not the same of “caused by” Hep-B, as if science does not begin with observations. My sharing of the research study as another way that scientists “report” possible causes brushed him the wrong way, and it was off to the races.
I have researched the allegations by Thompson, and as a rational skeptic, I find them deeply disturbing. More disturbing than the omission of the finding of increased risk of autism in vaccinated African American males and in the “isolated” cases of autism were the other studies Thompson mentioned – and the types of data analysis tricks used to make positive results, in the words of one analyst, “go away”. These references were backed up by emails obtained by Dr. Brian Thompson under the FOIA – and while the author of the email claims he did not mean to imply that they were analyzing to result, it is clear in the email that they were do exactly that. If the CDC analyzed to desired result, one must ask: which vaccines on the schedule are safe? DeStefano, Thompson’s boss, and senior author on one of the studies in question, has also admitted the omission of the positive result, and has admitted that it is possibility that some vaccines have triggered autism (but rarely). If these allegations are true, a new approach to vaccine safety research will be needed that guarantees the objectivity of the researchers involved. No one involved in vaccine safety research, and no one on the Vaccine Board should be allowed to have personal financial stake in the vaccines being developed or under consideration for addition the the pediatric schedule, and Thompson’s revelations draw into serious question the validity of the conclusions of numerous studies conducted by the CDC on vaccine safety.
The moderator of the site “stopped moderating my comments”, I presume as a way to shut my position down.
I am reproducing the text of the original post – and the comments that were allowed – from the blog post at “Left Brain, Right Brain”, that suggested that individuals could ignore the FDA warnings in the Hepatitis-B vaccine that it has been observed to cause autism. For the author of the original post, not enough kids in a study got autism – because not all kids did. I am reproducing the discussion verbatim as of Sept 8, 8:10 PM. I show where my replies were allowed in, however clearly the site owner decided that allowing further open discussion was not to be tolerated.
Before we get started, I want to say that the moderator and author of the original post claims to report that the CDC data analysis plan included consideration of birth certificate variables before the data were looked at. However, the question is not whether they planned to get data from birth certificates or not – clearly that was the plan. The question is whether they are allowed, under their own data analysis plan to change the inclusion criteria to whether patients had what they considered “valid” birth certificates, or was the plan to use covariates obtained from the birth certificates to control for what the CDC has called “confounders”. Either way – and this is important – while the data analysis plan does include consideration of birth certificates, sometimes as inclusion criteria, sometimes as a source of information on so-called “confounders”- it does not say that results for any particular subgroup will be omitted from the final, published paper. DeStefano seemed stumped to find that the Georgia birth certificates do not contain the data that the study alleges were needed from those certificates – and clearly the data on race were available from other sources, so there was never any reason to require the birth certificate (all patients were Georgia citizens, and “race” was available from school records).
Also, it has been claimed that because the subgroup analyses omitted were never in the original data analysis plan, that there is no problem. Yes, there is still a problem, an even bigger one, in my view. For the team to conduct a bunch of subgroup analyses not in the data analysis plan, and them cherry-pick only the negative associations to publish, is, to me, a double whammy. Data analysis plans in such studies are necessary to prevent arbitrary changes that lead to arbitrary desired results. There should have been a review board to which proposed changes to the plan were submitted. According to Thomspon, there was no such board.
And Thompson revealed as well that there was a conscious, concerted decision to exclude results showing positive association (Congressional Record):
“‘My primary job duties while working in the immunization safety branch from 2000 to 2006, were to later co-lead three major vaccine safety studies. The MADDSP, MMR autism cases control study was being carried out in response to the Wakefield-Lancet study that suggested an association between the MMR vaccine and an autism-like health outcome. There were several major concerns among scientists and consumer advocates outside the CDC in the fall of 2000, regarding the execution of the Verstraeten Study. One of the important goals that was determined up front, in the spring of 2001, before any of these studies started, was to have all three protocols vetted outside the CDC prior to the start of the analyses so consumer advocates could not claim that we were presenting analyses that suited our own goals and biases. We hypothesized that if we found statistically significant effects at either 18 or 36 month thresholds, we would conclude that vaccinating children early with MMR vaccine could lead to autism-like characteristics or features. We all met and finalized the study protocol and analysis plan. The goal was to not deviate from the analysis plan to avoid the debacle that occurred with the Verstraeten thimerosal study published in Pediatrics in 2003.
‘At the Sept 5th meeting we discussed in detail how to code race for both the sample and the birth certificate sample. 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 2002, not to report any race effects from 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 hardcopy documents that we had thought we should discard, and put them into a huge garbage can. However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hardcopies of all documents in my office, and I retain all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.’
Whether fraud was intended or not, calling a variables like birthweight a confounder and (as in another study) treating as a variable to control variable instead of a co-factor, when toxicity likely interacts with body weight draws the legitimacy of the VSR ‘science’ done by this team into serious question. They were so bent on trying to prove no association for the main effect, they did not realize that their studies could be used to shed light on causes of autism in general. What a wasted opportunity.
I reproduce the entirety of the first internet “debate” on my character (oops) I mean on Dr. Thompson’s allegations between Pro-Vaccination people. A second, nearly simultaneous debate (slay?) also devolved into an interrogation of my credibility for calling for vaccine safety research, and well, that internet debate, like the first one, destroyed my career. Again. After the first one did. The day before. Twice in 24 hours!.
Well, good thing my career is not up for consideration. Thompson’s statements include omission of link in the African American male subset, and, perhaps more damning, omission of a result that showed high risk of autism due to vaccine in children who had no other predictor variables indicating high risk of autism from causes other than vaccine – so-called ‘isolated autism’. This result would have confirmed the observations of thousands of parents who have reported watching their children regress into autism after vaccination.
I welcome any and all discussions and discussants from Pro-Vaccine People, Anti-Vaccine People, and, well, just People who are interested in truly understanding why Thompson’s revelations show clearly that the CDC let the American people down in a terrible manner by conducting “Science” that had a specific agenda to demonstrate. Character attacks are evidently welcome at Left Brain, Right Brain and that other site, Respectful Insolence.
-James Lyons-Weiler, PhD
President & CEO
Institute for Pure and Applied Knowledge
BEGIN COPIED RIGHT BRAIN, LEFT BRAIN PAGE:
One of the primary subjects for those promoting vaccines as a primary cause of autism is the Hepatitis B vaccine. This vaccine is given at birth and represents a child’s first exposure outside the womb to a vaccine and, in the old days, to thimerosal. David Kirby attempted to link the rise in autism prevalence to the introduction of the HepB vaccine. Others have claimed that the rates of special education placements are 9 times higher amongst children given the HepB vaccine at birth. Here is the abstract for (Hepatitis B triple series vaccine and developmental disability in US children aged 1–9 years rel=”nofollow”)
This study investigated the association between vaccination with the Hepatitis B triple series vaccine prior to 2000 and developmental disability in children aged 1– 9 years (n¼1824), proxied by parental report that their child receives early intervention or special education services (EIS). National Health and Nutrition Examination Survey 1999–2000 data were analyzed and adjusted for survey design by Taylor Linearization using SAS version 9.1 software, with SAS callable SUDAAN version 9.0.1. The odds of receiving EIS were approximately nine times as great for vaccinated boys (n¼46) as for unvaccinated boys (n¼7), after adjustment for confounders. This study found statistically significant evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B vaccine, during the time period in which vaccines were manufactured with thimerosal, were more susceptible to developmental disability than were unvaccinated boys.
The recent study on thimerosal and autism gives us a look at how the Hepatitis B vaccine might (or might not) be linked to autism. Exhibit 16.1 on page 82 of volume 2 of the technical report is a graph of HepB vaccine uptake among autistic children (AD) and non-autistic children (controls)
Here is that exhibit, showing the total number of vaccines (count) and amount of thimerosal (amt) for all vaccines and for HepB alone:
The top right graph shows the number of HepB vaccines for autistic kids (solid line) and non-autistic kids (dotted line). They are, to all intents and purposes, the same.
Take a look at the birth dose. Not every kid got it. Maybe about 1/2 got the birth dose at birth, and about 2/3 got it within the first few days.
If the birth dose of HepB caused autism to any significant degree, I would expect to see a higher percentage of autistic kids than non-autistic kids getting that shot. It just didn’t happen. Take a closer look at that graph:
The same percentage of got the HepB shots–all 3 of them– as non-autistic kids.
Still wondering about that birth dose? Let’s zoom in on the graph:
Those lines are right on top of each other.
The HepB hypothesis won’t go away. Just like the thimerosal hypothesis or the MMR hypothesis. Just today, Mark Blaxill and Dan Olmsted put out a very long post at the Age of Autism blog pushing the idea. They use the bad and worsestudies from Thoughtful House on infant macaques to bolster their arguments.
The funny thing about evidence is, some people never accept it.