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:
Autism causation and the Hepatitis B vaccine: no link
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:
![Price-HepBGraphs1-copy[1]](https://lbrbblog.files.wordpress.com/2015/03/price-hepbgraphs1-copy1.png)
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:
![Price-HepBGraphs2[1]](https://lbrbblog.files.wordpress.com/2015/03/price-hepbgraphs21.png)
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:
![Price-HepBGraphs3[1]](https://lbrbblog.files.wordpress.com/2015/03/price-hepbgraphs31.png)
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.
Orange LanternSeptember 16, 2010 at 02:08 #
Nice analysis. I have thought for a while that if any vaccine in the future gets the MMR scrutiny treatment, it’s probably going to be hep B. It hit right during a notable period of rise in ASD diagnoses, and people associate it only with naughty behaviors.
Regarding the Gallagher 2007 study concerning hep B and special services:
I’ve seen this study creep out once or twice, most notably in JB Handley’s“Unmitigated Disaster” rant. If I understand it correctly, it’s culled from NHANES survey data and thus is parent-reported.
Interestingly, the findings section briefly mentions:
So, if we are to consider this data reliable (which we probably shouldn’t), we must urge girls to be vaccinated fully for hep B because it apparently makes them less disabled.
Funny how this aspect is completely neglected in the conclusions section. I get the sense that the authors just combed NHANES data until they finally found a vaccine with a bad association that was statistically significant (which, statistically speaking, is going to happen by chance once in a while).
a naive parentAugust 8, 2012 at 16:44 #
we do not know why boys develope AUTISM more than girls, but wait til one of your kids or grand kids get sick, realy sick after a vaccine and develope ASD, then come and write this.
ThomasAugust 8, 2012 at 19:32 #
“we do not know why boys develope AUTISM more than girls, but wait til one of your kids or grand kids get sick, realy sick after a vaccine and develope ASD, then come and write this.”
Dear naive “parent” – if you read this blog you’d know that virtually everyone who posts here has an autistic child or is autistic him or herself. That’s why we care when people tell lies about the causes of autism. Hope that helps.
DJEBFebruary 13, 2015 at 00:06 #
Appeal to pity fallacy.
NeuroskepticSeptember 16, 2010 at 17:08 #
“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 is one of those “too good to be true” results. If that were true, the # of kids needing special ed would have increased by a factor of 9 when the HepB vaccine was introduced. OK technically x7 because only 74% of kids got it according to that study. Given that this unprecedented epidemic of special needs obviously didn’t happen, we can conclude that this is wrong, even setting aside everything else…
NeuroskepticSeptember 16, 2010 at 17:10 #
Or in fact, as Orange Lantern points out, we would have had rates in boys going up by 7 and rates in girls slashed by more than half…
Billy CrespSeptember 16, 2010 at 21:04 #
I looked on page 81 of volume 2, and wonder why they included in the count of number of vaccines received, types of vaccines that ever contained thimerosal, while they counted each receipt of those types whether they contained thimerosal or not.
Science MomSeptember 16, 2010 at 22:20 #
@ Billy, We may (I’m just guessing really) see a future study that examines a potential dose-response and autism (i.e. ‘too many too soon’). Just as we did with the same dataset used for the previous VSD study of autism and neurodevelopmental outcomes. In any event, it is no easy task to mine the VSD so perhaps some kind of future study parameters were included.
Brant BeauharnoisMarch 13, 2013 at 17:27 #
Your liver helps your body digest food, store energy and remove poisons. Hepatitis is a swelling of the liver that makes it stop working well. It can lead to scarring, called cirrhosis, or to cancer.:
Remember to visit our own internet page
<,http://www.healthmedicinelab.com/incarcerated-hernia/
JenniferNovember 16, 2013 at 10:50 #
Helpful information. Lucky me I discovered your website accidentally,
and I’m shocked why this coincidence didn’t took place
earlier! I bookmarked it.
travail a domicilMarch 18, 2014 at 18:43 #
I always used to study paragraph in news papers but now as I
am a user of web therefore from now I am using net for content, thanks
to web.
jameslyonsweilerSeptember 3, 2015 at 19:13 #
And so that’s why the US FDA lists “AUTISM” as a possible side effect of the Hep-B vaccine. Got it.
Sullivan (Matt Carey)September 3, 2015 at 19:40 #
You should look up the vaccine insert and check for your mistake.
“Reported” is not “possible”. As in, “among the side effects reported for this vaccine we include autism” is not the same thing as “among the side effects demonstrated as possible for this vaccine we include autism”. The exact wording on the insert is different as I recall, but this example shows the mistake you are making.
So “got it” is somewhat ironic when you clearly don’t “get it”. Now that you are aware of your mistake, will you stop spreading this particular bit of misinformation? I sincerely doubt it.
jameslyonsweilerSeptember 5, 2015 at 00:09 #
You should stop spreading your disinformation:
J Toxicol Environ Health A. 2010;73(24):1665-77. doi: 10.1080/15287394.2010.519317.
Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997-2002.
Gallagher CM1, Goodman MS.
Author information
Abstract
Universal hepatitis B vaccination was recommended for U.S. newborns in 1991; however, safety findings are mixed. The association between hepatitis B vaccination of male neonates and parental report of autism diagnosis was determined. This cross-sectional study used weighted probability samples obtained from National Health Interview Survey 1997-2002 data sets. Vaccination status was determined from the vaccination record. Logistic regression was used to estimate the odds for autism diagnosis associated with neonatal hepatitis B vaccination among boys age 3-17 years, born before 1999, adjusted for race, maternal education, and two-parent household. Boys vaccinated as neonates had threefold greater odds for autism diagnosis compared to boys never vaccinated or vaccinated after the first month of life. Non-Hispanic white boys were 64% less likely to have autism diagnosis relative to nonwhite boys. Findings suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 (from vaccination record) had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates during that same time period. Nonwhite boys bore a greater risk.
PMID: 21058170 [PubMed – indexed for ME
Sullivan (Matt Carey)September 5, 2015 at 02:12 #
So, you can find an abstract and copy and paste. Doesn’t show you understand the study or the huge limitations. That’s not discussion. That doesn’t show anything, except that you will accept whatever shred of evidence supports your belief.
So, what do you think about the fact that the study basically compares older kids to younger kids–i.e. they ignore a cohort effect?
jameslyonsweilerSeptember 5, 2015 at 03:05 #
That’s one way to interpret it. The other way to interpret it is to make note of the main effect that the authors of the study REPORTED. More to the point, you keep posting that “REPORTED” does not mean “POSSIBLE”, as if that is somehow profound. Actually, it is utter nonsense. In the logic of science, if something is NEVER SEEN, it is thought to be highly IMPROBABLE. Things or events that are seen are generally considered POSSIBLE. Events that are REPORTED are, in fact POSSIBLE. Now back to other question, I’ve done plenty of case/control and cohort studies. As you know, autism diagnosis rates have been increasing – meaning there will be an age effect. You ascribe it to cohort effect, but that is not the proper context of the study. The authors knew this. I knew this. And you know this. But you say what you say, anyway. And try to shame others for reading the warning from (who? some guy? no. THE FDA) that Hep-B may cause autism. 6 million autistic children are more important than your lame attempts to confuse with semantics. How many autistic children will it take to convince you that things that are reported are possible? Are 6 million not enough?
Now, as we were saying, the FDA does in fact consider autism to be a possible side effect from the Hep-B. And the vaccine court has in fact awarded 83 families funds due to the damage of autism due to vaccines.
By the way, I am 100% PRO-VACCINE. Always have been, always will be. It’s up to the CDC and Pharma to clean up their act in their approach to science, or step aside and let truly independent research scientists without profit motive conduct the research on safety & efficacy. With their fraudulent “science”, cooking the data, omitting results, repeated analyses until the observed associations of high risk of autism due to various vaccines dissappeared, the CDC has abdicated their responsibility as a protector of the public health.
GAME OVER.
Sullivan (Matt Carey)September 5, 2015 at 03:45 #
It’s not profound. It’s just pointing out the intellectual dishonesty of people who misrepresent what the vaccine insert actually says.
The man with integrity in your position would just admit that he made a mistake. Which leads me to the conclusion (a) you don’t have integrity and (b) you knew you were misrepresenting the facts.
I hope you are really active out there with your misinformation campaign. When I started out in this, looking for the answers, I found people like you. And you (as a group) were instrumental in showing me that your arguments are false.
You dodge, you weave, but you don’t address the huge failing with the study (OK, ONE of the huge failings). Yes, I do think the authors knew that they had a cohort effect–as in they were comparing an older cohort from an era with low diagnosis rates to a younger cohort with better awareness and diagnosis rates. Instead of trying to control for this and instead of alerting their readers to the giant flaw in their study, they published junk. It’s politics, not science. It’s PR not science.
Don’t pull the passive aggressive “shame” thing. I don’t think you feel shame in being called out for your misinformation efforts. Again, cheap internet debate tactics only teach the people who read that you have no susbtance.
jameslyonsweilerSeptember 5, 2015 at 03:58 #
I’m sorry, I was not intending on being passive aggressive at all. I thought I was being rather uncharactertistically aggressive. But ad hominem attacks are really all you have left. This discussion is not about me. It’s about the insert, and the flaws in your callous attempts to minimize the intent of the FDA. So, like I said, GAME OVER. Hope you had fun. Everyone, please go ahead and interpret the insert as intended by the FDA, regardless of this person’s attempts to overrule the FDA’s warning.
By the way, many don’t know that your doctor has to, by law, give only one sheet on side effects per vaccine. Often there are often as many as 25 additional pages they must review with you if you request them. Ask them to show you the studies that shows no association. Ask them whether they believe that Dr. Thompson’s revelations cause them to doubt the validity of the studies conducted by the CDC showing “no association”. If they cannot answer that question, then suggest to them that they might want to sign this petition requesting immediate Congressional hearings so they can get back to actually knowing whether the adjuvants and preservatives they are being asked to put into their patients’ bodies are in fact safe:
http://www.petition2congress.com/18382/immediate-congressional-hearings-on-cdc-fraudulent-pediatric-vacc/
Sullivan (Matt Carey)September 5, 2015 at 03:57 #
“By the way, I am 100% PRO-VACCINE”
Frankly I don’t care what label you attach to yourself. I care about the fact that you are willfully spreading misinformation. And you don’t have the courage to admit your mistakes.
jameslyonsweilerSeptember 5, 2015 at 06:55 #
Really? What alleged “mistake” was that? Please be specific. And labeling? Well, you have called me an “arse”. Name calling always proves you right. Again, you have nothing other than ad hominem attacks.
ChrisSeptember 5, 2015 at 00:29 #
Yawn:
http://leftbrainrightbrain.co.uk/2009/09/17/another-weak-study-proves-vaccines-cause-autism/
and
http://lizditz.typepad.com/i_speak_of_dreams/2012/07/1-hepatitis-b-vaccination-of-male-neonates-and-autism-diagnosis-nhis-1997-2002-2010.html
Science MomSeptember 5, 2015 at 05:55 #
Matt, James Lyons-Weiler made a bit of an arse of himself along the same lines, i.e. doesn’t understand statistical analyses or study design over at RI recently:http://scienceblogs.com/insolence/2015/08/05/the-cdc-whistleblower-william-thompson-appears-to-have-gone-full-antivaccine/#comment-412878
He appears to be yet another once-respected scientist who is cosying up to the anti-vaxx ignorati for whatever reason.
Sullivan (Matt Carey)September 3, 2015 at 19:49 #
I assume you are referring to this
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101580.pdf
Did you not read the actual source before, or did you not understand it? Or did you not care that the facts are different from your claim?
douglasjebarnesSeptember 4, 2015 at 04:25 #
Ah, the hazards of copying and pasting what you read on an anti-vax site.
Try reading the rules behind what gets put in an insert, specifically, Part C from “Guidance for Industry Adverse Reactions: Section of Labeling for Human Prescription Drug and Biological Products — Content and Format”:
“Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075057.pdf
In other words, if someone says that there was a severe adverse reaction – no pathological report needed – then the drug company is legally obliged to put it on the label.
This can lead to a scenario like the following: even though a multi-year international study with over 1.4 million children looking into a causal connection between autism and vaccines has turned up no connection, manufacturers are still legally obligated to print it as an adverse reaction on the label.
http://www.sciencedirect.com/science/article/pii/S0264410X14006367
jameslyonsweilerSeptember 5, 2015 at 07:25 #
Science mom, claiming that I don’t understand study design or statistical analysis is amusing. That should play extremely well with those who know who I am and what I do. “Once-respected?” Since when does a party of one define and industry’s consensus? “COZYing up”, eh? Again trying those ad hominem attacks. Arse? Science Mom, Matt, every time you try these attacks, you are merely proving the futility of your position.
I used to teach a course in study design – to graduate students – and included a good amount of ethics in the course. And for the last 20 or so years I have analyzed -omic data from cohort studies, case/control, outcomes predictions. I helped set the standard for phase biomarker development studies in cancer, and have designed entire paradigms to conduct data analysis so the analysts don’t end up fooling themselves.
The vaccine safety “science” whistleblower at the CDC – and now another one at Merck re: MMR and autism – are the ones you should argue with, not me. I merely show others what they have said. Kill the messenger, kill the message? There are 6 million people with autism with parents who will never go away who now know that the CDC fudged the data, in spite of the media’s silence on the real story. The CDC went off-protocol and changed in the inclusion criteria, reported some but not all subgroup analyses, excluded individuals to reduce statistical power, peeked at the data first, then changed who was included. Too many people know this to have it go away by name-calling.
See, vaccine safety research is a bit like baby car seat safety research. If millions of people said that the car seats being used were causing permanent brain damage to, say, 2% of the babies whose parents use those seats, well, there would be a recall. There would not be retrospective epidemiological studies, and certainly not conducted by the car seat manufacturer! Now if the National Transportation Board had put a warning out that those seats were dangerous, recommended that they be banned, but the seats continued to be sold, and babies continued to get brain damage, well, there would criminal prosecutions. If a whistleblower came out and said that the manufacturer knew that the car seats caused brain damage, but covered it up by falsifying safety testing results, well, there would be additional charges and fines and lawsuits.
Science is for asking questions, and being ready to throw out old knowledge in light of new data. The revelations of Dr. Thompson especially (which, by the way, are now entered in the US Congressional Record) reveal outright fraud admitted by himself, and alleged by his supervisors. To any objective scientist, that means that we do not know which vaccines are safe, and which are not. For which other studies did they cook the data?
Thank you for sharing my link, by the way, there is a good deal of information there about emails from and to the CDC by analysts pleading that they CDC scientists accept the association results in the name of objective science.
Science MomSeptember 5, 2015 at 17:42 #
It is amusing because you should know better but have turned your back on scepticism to embrace pseudo-science. What do you do? You no longer have a post anywhere and you’re writing for the likes of Greenmedinfo and Age of Autism. Not very impressive.
Where are those ethics and knowledge in study design now as you are defending Hooker’s execrable “re-analysis” and accepting Thompson’s (completely unsupported) statements as fact and invoking Goodman and Gallagher’s demonstrably false study? And using those to propagate the same tired refuted claim that vaccines cause autism. You are really off the rails.
Sullivan (Matt Carey)September 5, 2015 at 19:56 #
“See, vaccine safety research is a bit like baby car seat safety research. If millions of people said that the car seats being used were causing permanent brain damage to, say, 2% of the babies whose parents use those seats, well, there would be a recall.”
No, if there were *data* showing that there was a risk. Parents raising an alert would put people into high gear to see what, if any, problem there was.
Ironic that you make such ignorant statements like this when you claim such a strong background, isn’t it?
Sullivan (Matt Carey)September 5, 2015 at 19:57 #
No one argues with you. We are pointing out your mistakes. Too bad you can’t see that as you could correct them.
Sullivan (Matt Carey)September 5, 2015 at 20:19 #
“Science mom, claiming that I don’t understand study design or statistical analysis is amusing. ”
It’s an observation based on your comments here. Your resume doesn’t trump your comments here.
No one is attacking you. You can stop trying that as a defense. Pointing out your flawed logic isn’t an “attack”.
jameslyonsweilerSeptember 8, 2015 at 03:08 #
No, actually it (my resume) does trump any excluded comment that someone thinks I should have made but did not because it was not my point. Merely because a planetary scientist discussing Mars does not also mention Neptune does not mean they know nothing about Neptune……..
My point is deeper than name-calling… look at the actual modeling out of variation from highly collinear variables gestational age and birthweight – both redundant variables – a component very likely related to ill effects of any neurotoxin – treated as a “Control” variable instead of covariate?? Only leading residuals to be explained?? Their studies do not pass muster, and should really be looked at very, very closely. Thompson’s allegations are very detailed and any honest academic would shudder to think that senior CDC scientists pushed others to desired result on something this important.
Sullivan (Matt Carey)September 8, 2015 at 04:01 #
We have a phrase for people who interview and say “my resume trumps my actions”. Not hired.
jameslyonsweilerSeptember 8, 2015 at 04:03 #
Sorry, not on the market.
Sullivan (Matt Carey)September 8, 2015 at 04:25 #
Let’s make this more clear then, eh?
Your attempt to use your resume to win an argument is sad. Use facts and logic. Not your claimed reputation.
jameslyonsweilerSeptember 8, 2015 at 04:37 #
I am content to conclude that you do not understand why we are even discussing my resume. I did not bring it up. If my resume is challenged, am I not to defend it?
One of your colleagues thought they would point out that I did not know something, merely because I did not bring it up.
Your community cannot handle an objectivist. I’ve been called a creationist, my resume questioned, an anti-vaxxer… sorry, none of these have stuck because they are non-sequitur. I am using logic. I merely chose to be thorough in my responses, and now you find it “Sad” that I think my resume trumps some guy on the internet’s opinion of what I should have said. Think what you may. You make yourself VERY clear, Matt. No doubt about where you are coming from.
Sullivan (Matt Carey)September 8, 2015 at 04:48 #
“I am content to conclude that you do not understand why we are even discussing my resume. ”
Wow. More silly internet debate tricks. I understand what you are tryingto do. Don’t try to put words into my mouth. I’m telling you that you are failing.
“Your community cannot handle an objectivist. I’ve been called a creationist, my resume questioned, an anti-vaxxer”
Show me where I’ve done this? I haven’t. So this is just more chaff. More noise.
You aren’t using logic. I keep pointing that out. I invite and invite you to actually participate in a discussion. But you can’t.
One thing I learned in grad school–a lot of fools get Ph.D.’s. And, yes, I include you in that company. I do this an an experimentalist. I’ve observed, I’ve presented my observations, and you are clearly a fool.
Did I read that you write for the Age of Autism blog? Makes sense. They just don’t care about logical arguments or facts.
Sullivan (Matt Carey)September 8, 2015 at 04:55 #
How many comments did you make in this thread? And you can’t actually present a cogent argument. You rely upon your resume. You rely upon hearsay about what Thompson said. You refuse to even address the discussion where I clearly demonstrate that the hearsay is wrong. You started by throwing out an abstract with no discussion. Many comments later, you still haven’t actually discussed the facts of that paper and the clear criticisms of that study.
Nice troll. Well done.
I hope you are trolling, because if you aren’t you really don’t understand what you are talking about, but you think you do.
And that is truly sad.
Good day to you. And good bye.
Sullivan (Matt Carey)September 5, 2015 at 20:20 #
” I merely show others what they have said. ”
Ironic that. My recent articles are all about what he said.
Science MomSeptember 8, 2015 at 16:02 #
Several have read DeStefano et al. 2004 very closely and I’m left wondering if you have at all. You tried to pull this stunt over at Respectful Insolence and they weren’t “modelled out” at all.
I’m sorry but in what world do mere details qualify for accuracy and fact? Where is evidence Mr. Lyons-Weiler?
Science MomSeptember 8, 2015 at 16:07 #
Creationist? Try reading again, this time for comprehension:http://scienceblogs.com/insolence/2015/08/05/the-cdc-whistleblower-william-thompson-appears-to-have-gone-full-antivaccine/#comment-412928 Of course your resume is questioned as you are the one using it as an appeal to your own authority rather than provide any evidence to support your claims and those of Thompson and Hooker. You talk like an anti-vaxxer so…
Sullivan (Matt Carey)September 5, 2015 at 20:34 #
” The CDC went off-protocol and changed in the inclusion criteria, reported some but not all subgroup analyses, excluded individuals to reduce statistical power, peeked at the data first, then changed who was included. ”
No, they didn’t. Did you read the protocol? I did. Posted it here. Showed that they didn’t go off protocol. I’ve discussed how they did report on the subgroups. And we know that the birth certificate sample was planned before they saw the race data, from the information Brian Hooker released (and you can also read it in his conversations with Thompson–makes you wonder why he said something different when he released his paper, doesn’t it?)
One of us has gone to the sources to find information. The other–you–is repeating the stories told by Brian Hooker and Andrew Wakefield.
And you wonder why people question your reasoning.
jameslyonsweilerSeptember 8, 2015 at 03:00 #
According to Thompson, They knew about the positive association in African Americans first – and then they decided to remove “valid birth certificate” from the inclusion criteria for that subgroup. The effect was to reduce the sample size, cutting power-to-detect, and then the association was lost. According to Thompson ( and to most objectivist scientists), peeking at the data first, and then changing the criteria for inclusion is cheating.
They did not report the initial finding of the association, but did report negative associations in the other subgroups.
I am restricting my consideration of what I say Thompson said to what I’ve read from the transcripts first-hand. He also discusses at length how, when writing up the results of any positive finding, he would put extra effort into making the sections describing the positive associations lengthy, on purpose, due to his past experience in the culture in which any positive association was actively squelched, only to find that conclusion watered down or deleted entirely. He discusses how a peer reviewer was confused in one study because the data clearly supported a causal link, but the text did not match the reported results.
I encourage a full read of the transcripts, they are bone-chilling.
To me, Hooker and Wakefield are not central to what Thompson has revealed.
Sullivan (Matt Carey)September 8, 2015 at 04:02 #
“They knew about the positive association in African Americans first – and then they decided to remove “valid birth certificate” from the inclusion criteria for that subgroup. ”
Really (actually I know the answer–it’s no)?
I quoted the book with the pertinent exchange. Thompson declined when asked to say that. But you still want to use him as your sock puppet.
I did read the transcripts. Either you have not or you didn’t understand them. As the above example clearly shows.
Sullivan (Matt Carey)September 8, 2015 at 04:05 #
So, did you notice where Thompson and Hooker discussed when the race effect was first observed? Hooker noted the date (November). Thompson was surprised that it was that early. He felt it was found later.
Important point–the protocol was written in September. Including the call for a birth certificate sample.
So, the birth certificate sample decision came months before the first race data were analyzed.
“To me, Hooker and Wakefield are not central to what Thompson has revealed.”
That’s very strange because you repeat the story given my Wakefield and NOT the information by Thompson.
Sullivan (Matt Carey)September 6, 2015 at 04:28 #
“The revelations of Dr. Thompson especially (which, by the way, are now entered in the US Congressional Record) reveal outright fraud admitted by himself, and alleged by his supervisors. To any objective scientist, that means that we do not know which vaccines are safe, and which are not. For which other studies did they cook the data?”
First–“and alleged by his supervisors”. Where did you get that–or did you make it up. Provide the quote that says the supervisors alleged this. I pose this as a request, but that’s just wrong on your part.
Now, where in the statement read into the record is the word “fraud” stated by Thompson? Answer–it isn’t. What phrase are you misrepresenting as “fraud”. Here’s where Brian Hooker tried to get Thompson on tape saying what you seem to think he said
http://leftbrainrightbrain.co.uk/2015/09/03/heres-a-statement-by-william-thompson-that-they-wont-be-quoting/
“For which other studies did they cook the data?”
Well, did you read the transcripts of the Hooker/Thompson calls? Thompson says that the other studies he worked on were good. And he worked on some of the big thimerosal studies.
He didn’t say it.
jameslyonsweilerSeptember 8, 2015 at 02:50 #
Sadly, I don’t make things up, Matt.
You can read the entirety of the transcripts of Dr. Thompson’s reveals in the book “Vaccine Whistleblower”.
http://www.amazon.com/Vaccine-Whistleblower-Exposing-Autism-Research/dp/1634509951
I would be happy to pay for a copy of the book and have it sent to you. Just need your postal address – you can send it to me at jim [at] ipaknowledge.org
Sullivan (Matt Carey)September 8, 2015 at 02:56 #
You might notice with minimal effort that I’ve been quoting that book for some time now. I got an advance copy and blogged the book the day it came out.
I take it you aren’t even reading my responses in this very discussion. For example
http://leftbrainrightbrain.co.uk/2010/09/16/autism-causation-and-the-hepatitis-b-vaccine-no-link/comment-page-1/#comment-215594
In which I ask you if you read the book and then give a quote from the book.
Perhaps you could donate the cost of the book to a legitimate autism organization instead.
jameslyonsweilerSeptember 8, 2015 at 03:50 #
Matt, I will honor my offer, and I will be happy to donate the cost of the book to any autism not-for-profit that you think is legit. Just send me the info to my email.
If you read the book, then why, one wonders, did you not report the claims by Thompson of pressure from supervisors – the fact that Thompson saw this kind of pressure applied to others – that it was routine, the peer-reviewer confused due to the mismatch of the text and the reported results in figures and tables, the fact that Thompson tried to make it difficult for them to excise the positive associations when found… I could go on, but I’ll save it for the chapter in my next book in which I celebrate the successes of vaccines and report on Thompson’s reveals. I report the Wakefield incident as well (in case you were going to ask, I don’t want to be found guilty of not mentioning that…)
One wonders if you were only interested in finding bits and pieces of what you thought could be used as exculpatory evidence?
Your resistance to these additional parts of Thompson’s revelations is puzzling at best.
The cost of autism to families is staggering – and to society immense. The scientific community needs to take Thompson seriously, and apply the level of scrutiny to the CDC’s vaccine studies from that time they deserve due to Thompson’s claims, such as
“And if anything, people that have been my immediate supervisors have broken laws.”
and
“So anyways, we did the whole thing; we wrote the manuscript; we initially had pretty strong
wording, like what you’re saying about the association. And then it sat in clearance for a year, and people just hammered away at the paper and watered in down more and more and more. So, you got the manuscript you ended up with, which is the published manuscript – not the published; you ended up with the final, cleared manuscript with just the most, you know, whitewashed discussion ever”
And then on the peer reviewers:
“Three people who had no vested interest in the outcome of it and to say “Why aren’t you
talking about significant results in the paper?”
And all of this to bury a positive finding of an association between thimerosal and TICS.
Anyone who has not read the full transcript, do yourself a favor, read it for yourself, and do not rely on cherry-picked excerpts from Matt, or, for that matter, from me.
Sullivan (Matt Carey)September 8, 2015 at 04:07 #
Do you have an autistic child?
If not–do not presume to lecture me about the cost. You have no standing to do so. Since you phrase this as an outsider to our communities, I assume you are, indeed, an outsider.
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Sullivan (Matt Carey)September 8, 2015 at 02:59 #
You keep doing silly “trump card” arguments.
“have you read this book”, “here’s an abstract to a study I don’t understand and didn’t read but I think it shows you are wrong” and the like.
You lack substance. A lot of smoke. Perhaps some mirrors. But no substance.
I read the book. I analyzed it. And all you do is pretend like it is some sort of trump card in an internet debate. This is real life to me–not some foolish game like it is for you. I don’t care that I point out what a fool you are making of yourself. I would much rather do something other than waste my time countering the misinformation you spread. But your misinformation causes harm in my community. So counter it I will.
jameslyonsweilerSeptember 8, 2015 at 04:00 #
Matt – you can examine your own style of argumentation. You use the same tactics, over and over, with different people. It is disingenuous of you to try to call me out for using what you call “Trump card” tactics, when all I’m doing is providing sufficient evidence, as reported, that (1) The FDA insert should be taken seriously, (2) The CDC vaccine safety “science” on questions of autism & vaccines was anything but, (3) People with profit motives should not be in charge of public health decisions that effect, well, all of us.
The only discussion left I think is the one in which you say “Ok, so there are side effects. But they occur to so few people, the benefit to society vastly outweigh the costs”.
The answer to the “common good” is the following: The use of thimerosal and aluminum and other adjuvant ingredients was a choice made by man, not by nature or any deity – we don’t have to live with risks that lead to harm to thousands or millions.
So I’ll ask you, Matt, do ANY vaccines have any side effects that anyone should be concerned about under any circumstances?
Sullivan (Matt Carey)September 8, 2015 at 17:58 #
“So I’ll ask you, Matt, do ANY vaccines have any side effects that anyone should be concerned about under any circumstances?”
Why ask when you could find my opinion on this website?
Because you want to paint me as an extremist who doesn’t believe that there are any adverse reactions, that’s the most likely answer. Of course there are side effects and rare adverse reactions. Autism is not an adverse reaction to thimerosal nor is it an adverse reaction to the MMR vaccine. I would ask you if you accept that but it’s not fair because (a) you never respond directly to such questions and (b) you’ve used up your time on this blog by wasting everyone else’s time.
“You use the same tactics, over and over, with different people”
Yep. I present them with facts and logical arguments and I expect them to do the same. Which is where you failed.
” (1) The FDA insert should be taken seriously”
I do. You don’t. You misrepresent it. You play the common game of “the insert shows that the vaccine causes autism” when the insert specifically does not make that claim.
” (2) The CDC vaccine safety “science” on questions of autism & vaccines was anything but,”
Funny, you’ve never presented any actual data or facts to back that up. Just a lot of hearsay (misrepresenting what William Thompson actually said, for example) and nonsense arguments (as discussed in (1) above).
“(3) People with profit motives should not be in charge of public health decisions that effect, well, all of us.”
Andrew Wakefield. Profit motive. For 20 years. And a record of aversion to the truth. But you parrot him rather than look for facts.
The choice to prevent disease was a choice made by man. It’s a good decision. Why you suddenly rush to the “made by man” defense is beyond me. And, I suspect, beyond you.
Nature, and a deity if that’s your belief, created diseases which kill and maim. Presenting us with risks that lead to harm to millions or even billions. Your appeal to nature/God fails.
douglasjebarnesSeptember 8, 2015 at 17:05 #
“It is disingenuous of you…”
Looking through your post history here, if Matt were disingenuous, you’d be able to sue him for copyright infringement as you seem to have ownership over it.
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Brian DeerSeptember 8, 2015 at 07:38 #
You’d have to wonder if James has ever worked in an enterprise of any kind. He doesn’t seem to understand that Thompson’s unparticularised whining about his managers is what some employees do on an hourly basis.
That, in fact, is what emerges: including him volunteering that he had some kind of breakdown. He thinks the CDC is politicised, agenda-driven, full of people who do what’s expected of them rather than stand up for truth, freedom and the American way, cut corners, act unethically, and all the other things that employees often say about their management.
Fair enough. Might be right. But what you are seeing is someone who vented his frustrations over stuff you will find almost anywhere.
And yet: when he’s offered the opportunity to make the allegation that the charlatan Wakefield has disseminated, he baulks. He hears the question, plainly understands it, and declines to make an allegation of dishonesty. Indeed, he made a formal statement through his lawyer to the effect that reasonable people can disagree over the way the data was presented.
Given Matt’s quoting of the passages, plus Thompson’s written statement, plus the fact that Posey cited process not substance, plus the fact that no journalist has scored the front of the Washington Post, NY Times of Atlanta J-C, with revelations of fraud at CDC, I think the whole thing is bullshit. And Hooker and Wakefield know it’s bullshit.
LawrenceSeptember 8, 2015 at 11:07 #
If there was an actual story here, at minimum, FoxNews would be all over it – given their penchant to go after any government agency that even has a whiff of a problem, much less some kind of cover-up (VA, IRS, EPA, etc, etc.).
Of course, the anti-vaxers will continue to claim its all part of the conspiracy…..
Science MomSeptember 8, 2015 at 17:19 #
I’ve read it and am also reviewing it in parts. You are a credulous fool to believe what amounts to a petty, disgruntled, nasty employee griping and back-stabbing his colleagues and superiors.
Sullivan (Matt Carey)September 8, 2015 at 18:02 #
I haven’t seen any evidence that he actually read it.
A single damning quote from the book would suffice. One not already online. Funny how he claims that I cherry pick but (a) doesn’t put my quotes in context to show that I cherry pick and (b) relies on cherry picked quotes and misrepresentations made by others for his arguments.
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To be fair–he’s not responding because not coming back. He can’t. I’m not even moderating his comments any more.