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Tribeca Film Festival pulls Wakefield’s (faux) documentary

27 Mar

Below is a copy of statements posted to the Tribeca Film Festival (TFF) Facebook page. Responding to criticism about hosting a film promoting Wakefield’s failed views on vaccines and autism, Mr. De Niro first acknowledged that he had taken an active role in placing the film at TFF. Later, Mr. De Niro announced that the film was pulled from TFF and why.

I called the film a faux documentary, neither TFF nor Mr. De Niro has. My reasons are spelled out here.

I would like to thank Mr. De Niro for pulling TFF’s support from this film. While Mr. Wakefield will certainly find another venue to present this film, the stamp of legitimacy of having his film a “Tibeca Film Festival Official Selection” would have given Mr. Wakefield’s message a level of legitimacy it does not deserve.

vaxxed trailer screenshot

However, it must be said: this film should never have been a Tribeca Film Festival selection to begin with.

Here are the statements from Robert De Niro, from their Facebook page:

UPDATE: 3/26/2016 Statement from Robert De Niro, co-founder of the Tribeca Film Festival, regarding VAXXED at the Festival:

“My intent in screening this film was to provide an opportunity for conversation around an issue that is deeply personal to me and my family. But after reviewing it over the past few days with the Tribeca Film Festival team and others from the scientific community, we do not believe it contributes to or furthers the discussion I had hoped for.

The Festival doesn’t seek to avoid or shy away from controversy. However, we have concerns with certain things in this film that we feel prevent us from presenting it in the Festival program. We have decided to remove it from our schedule.”

3/25/2016 Statement from Robert De Niro, co-founder of the Tribeca Film Festival, regarding VAXXED at the Festival:

“Grace and I have a child with autism and we believe it is critical that all of the issues surrounding the causes of autism be openly discussed and examined. In the 15 years since the Tribeca Film Festival was founded, I have never asked for a film to be screened or gotten involved in the programming. However this is very personal to me and my family and I want there to be a discussion, which is why we will be screening VAXXED. I am not personally endorsing the film, nor am I anti-vaccination; I am only providing the opportunity for a conversation around the issue.”


By Matt Carey

Andrew Wakefield releases the trailer for his William Thompson video. Slick production and dishonesty

22 Mar

Remember the disasterous “Who Killed Alex Spourdalakis” movie? That’s the one where Andrew Wakefield was trying to create an autism reality TV show where he would swoop in with his “A”utism TEAM and solve problems for families and show that he was right all along. Except that after the “A”utism team filled a family with false hope, Alex’s mother and godmother brutally murdered Alex. Wakefield took on no blame. Instead he shifted blame from those who committed the act to mainstream medicine. Basically whitewashing a gruesome murder of a disabled young man.

I will note that in the trailer for “Who Killed Alex Spourdalakis”, Wakefield spliced video from a completely different story.

Or, remember when Brian Hooker published a paper claiming that CDC data shows that vaccines cause autism and Wakefield followed up with a YouTube video that was so over the top bad that he claimed that non only were the CDC (including a civil rights pioneer) were engaging in a new Tuskegee Experiment, but that they were worse than Hitler, Stalin and Pol Pot? Because, you see, those brutal dictators were at least sincere. No, I’m not making that up.

Wakefield has been working for some time to make a feature length film out of the Brian Hooker/CDC story. He has an early trailer for “Feast of Consequences” (as it was called then). Just as with the Alex Spourdalakis story, this trailer includes video unrelated to his actual story (the video of a police standoff and the pictures of the girl in the wheelchair appear to be from the Maryanne Godboldo story).

Well, not to be deterred from the film making business, Mr. Wakefield is at it again. This time with the full length movie, now called “Vaxxed”. Here’s the trailer:

The trailer starts with what appears to be a reenactment of a conversation between Brian Hooker (vocal advocate for the failed idea that vaccines cause autism) and William Thompson (CDC researcher):

Brian Hooker:

My phone rings and it’s Dr William Thompson

This is followed by recordings of a phone call with William Thompson:

“you and I don’t know each other very well. You have a son with autism, and I have great shame now.”

Then a narrator.

“There’s a whistleblower from the CDC who is going to come out and say that the CDC had committed fraud on the MMR study and that they knew that vaccines were actually causing autism”

Sit back for a moment and consider what your first impressions of this intro are. I know mine–they seem to be setting this up as the first or perhaps one of the early phone calls between Thompson and Hooker. Since the actual audio clips from Thompson weren’t that sensational, the narrator is quickly pulled in to tell us what really happened.

But this is Andrew Wakefield. And if we’ve learned anything about Andrew Wakefield over the years it’s that you have to check every single detail of what he’s saying. He does a lot of leading you to the conclusion he wants you to believe, whether the facts say something entirely different or not.

Let’s start with a small detail. I suspect many have already wondered why I referred to the clips from Thompson in the plural. It’s because that 10 seconds or so of audio is actually two different comments from Thompson spliced together. And taken out of context. We know this because a book was released with the transcripts of the calls that Brian Hooker secretly recorded.

“You and I don’t know each other very well” is from this part of a conversation. Well into the second call that Hooker secretly recorded. And Hooker didn’t start recording calls until later in their relationship, so this isn’t an introduction at all. We will get into the discussion of what Thompson meant later:

You and I don't know each other very well

“You have a son with autism, and I have great shame now.”

I have great shame

OK, the two clips are from completely different parts of a phone call that happened well into the Hooker/Thompson relationship. Wakefield spliced them together to create a story and, just in case we missed his point, brought in a narrator to tell us what the story “really” is.

So, documentary producer/director he is not. But we didn’t really expect that, did we?

Let’s take a look at those two exchanges in a bit more detail, shall we?

First, “we don’t know each other very well”, was Thompson saying that even after multiple previous exchanges, Hooker doesn’t understand Thompson’s motivations and fears. Hooker appears to be digging for dirt. Something about the behaviors of people at CDC. Likely to smear them later. This seems to be a bit of a trigger for Thompson as he has battled mental illness. He’s not comfortable because he can already see the day when people will say, “Well, he’s [Thompson] mentally ill and why would you believe anything he says, it’s just hearsay”. Hooker assures him that it’s none of their business, and that “I [Hooker] don’t want that to happen, period.”

That’s a heavily ironic thing to read now. Why? The only reason people know about Thompson’s personal medical history is that Brian Hooker and Andrew Wakefield made it public. Hooker and Wakefield filed a complaint with the Department of Health and Human Services and included this statement from William Thompson:

Ya know, I’m not proud of that and uh, it’s probably the lowest point in my career that I went along with that paper and I also paid a huge price for it because I became delusional.

And this exchange between Hooker and Thompson

Dr. Hooker: Did you raise that…did you raise that issue at the time?
Dr. Thompson: I will say I raised this issue…I will say I raised this issue, the uh…two days before I became delusional.

and

Dr. Thompson: It is one of the reasons I became delusional because I was so paranoid about this being published.

So, not only is “you and I don’t know each other very well” not a “Hi, you don’t know be very well, but I’m about to spill the beans” sort of statement, it’s basically Thompson saying that one of his big fears is, well, exactly what Hooker did to him: out his struggles with mental illness.

With friends like Brian Hooker…

So, the second part of the spliced statement that Wakefield included in his trailer, what is that in context? “You have a son with autism, and I have great shame now.” Is it, as the narrator leads us to think, a statement about fraud and that vaccines are proved to cause autism?

No. Or, in Thompson’s own words:

“No, no, no, no. Here’s what I shoulder. I shoulder that the CDC has put the research 10 years behind. Because the CDC has not been transparent, we’ve missed 10 years of research because the CDC is so paralyzed right now by anything related to autism.”

It’s a statement that in William Thompson’s view, the CDC hasn’t done enough vaccine/autism research. It’s a sentiment that I disagree with, given how much effort has been spent on researching the failed idea that vaccines are a primary cause of autism. But let’s move on.

Let’s instead move to the narrator. Recall his statement

“There’s a whistleblower from the CDC who is going to come who is going to come out and say that the CDC had committed fraud on the MMR study and that they knew that vaccines were actually causing autism”

So, what about Thompson saying the CDC committed fraud on the MMR study? Didn’t happen, that’s what. Yes, he had criticisms. He starts his one voluntary public statement with, “I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. ” But let’s stick to what we know Thompson said, rather than what Wakefield and Hooker claim he said in regards to fraud, shall we? What makes the decision to not report a finding “fraud” over a scientific decision? Well, Thompson never says in his statement that there was fraud or misconduct by the CDC team. He does say “Reasonable scientists can and do differ in their interpretation of information.”

Let’s back up a bit, what is the Hooker/Wakefield claim of fraud? In a nutshell, they claim that the CDC team found a result they didn’t want to make public and then changed the research plan/protocol so they wouldn’t have to report that. In this exchange from a phone call we can see Hooker apparently trying to get Thompson on tape saying this. Trying because Thompson refuses to say it:

Dr. Hooker: And then you basically deviated from that particular plan in order to reduce the statistical significance that you saw in the African American Cohort.

Dr. Thompson: Well, we, um, we didn’t report findings that, um…All I will say is we didn’t report those findings. I can tell you what the other coauthors will say.

As to the claim by the narrator that Thompson stepped forward and stated that …”that [The CDC] knew that vaccines were actually causing autism”. Nope.

Consider this part of the public statement by Thompson, a statement I doubt will be prominent in Wakefield’s movie

I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.

That is not the statement of a person who believes that vaccines have been shown to cause autism and that the studies to the contrary are “fraud”.

Also, Thompson provided a summary statement to Member of Congress Bill Posey. That was made public along with a great deal more documents when I released them here. What does Mr. Thompson have to say about the study in question showing that vaccines “actually cause autism”?

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.

Let’s give this finding the greatest benefit of the doubt. Let’s ignore that it is an incredibly weak and almost certainly spurious result. Even then, it doesn’t show causation. A study like this can’t. And anyone who has done scientific research (such as Brian Hooker and Andrew Wakefield) should know that.

But, hey, let’s just make this simple–if Thompson had said something clearly claiming fraud, clearly claiming that the CDC knew vaccines cause autism, Wakefield would have included that in his video. Instead he splices disparate conversations together and has his narrator tell us what we should think.

In other words, if Wakefield had the facts, he’d use them. Instead all I see is more smoke and mirrors.

And that’s just the beginning. The first 30 seconds. We could go on and on, dissecting the trailer frame by frame. It’s that bad. And this is just the trailer. He has a full film out now.


By Matt Carey

An Interview with Andrew Wakefield

16 Feb

Andrew Wakefield recently participated in a cruise/meeting called the ConspiraSea cruise.  Among the audience was Colin McRoberts, a skeptic.  He reported back during the cruise and, as you will see below, interviewed Dr. Wakefield.  Since much of the interview involves William Thompson, Mr. McRoberts asked for my input.

The interview is below.  Mr. McRobert’s words are in black, Mr. Wakefield’s in red and mine in green.  (If there are any mistakes in that formatting below, they are mine.)

The original interview can be found at  An Interview with Andrew Wakefield at


 

Andrew Wakefield and I were both on the ConspiraSea Cruise in January 2016. By the last full day of the cruise, we’d had a few encounters ranging from standing in the same line for coffee to a fairly tense exchange during one of his lectures. I asked Wakefield after that lecture if he would answer a few questions regarding the so-called “CDC Whistleblower.” He consented, and this is the interview that resulted. Wakefield was aware that I was recording and that I am a critic of his position on vaccines and autism; he did not refuse to answer any of my questions.

2016-01-29 15.13.13
Wakefield lecturing on the cruise

This transcript is my own work, and I welcome any corrections. I’ve edited it slightly to make it more readable and remove irrelevant dialog. I have also added parenthetical comments to note where a statement is inaudible on the recording, which is not of high quality, and provide my best guess at what was said in a few places. I have not changed the substance of any question or answer.

Wakefield answered several questions before I turned the recording on. According to my memory and my notes, I asked him questions about the Thompson documents such as what specific deviations there were from the approved study plan (as he had alleged such deviations in two lectures). He referred me generally to his letter of October 2014, written with Brian Hooker and attorney James Moody, and directed to the federal Office of Research Integrity. He indicated both that he had documents from Thompson at the time he wrote that letter, and that Congressman Posey subsequently received additional documents from Thompson. At that point I began the recording.

I am not an expert in the documents Wakefield discussed. So in order to provide context for these answers, we have asked Matt Carey of Left Brain Right Brain to provide commentary. Carey is a published scientist, a parent of an autistic child, and extremely familiar with the Thompson documents. He has written an in-depth analysis of the Thompson documents and was able to provide an important counterpoint to Wakefield’s claims. Please read that excellent analysis prior to this interview if you are not familiar with the affair. The questions and answers will make little sense without context.

My questions are in black, Wakefield’s answers are in red, and Carey’s comments are in green. We welcome your own comments as well.

So the Posey documents that were released are, as far as you know, the documents Posey was given? He hasn’t held anything back?

I think he has probably given Posey more documents than he’s given me. The reason for that is that I’ve just been given the Posey documents, and they’ve been released and they’re available to anyone—you can get them.

I’ve got them.

And I have not been through them as yet, so I do not know to what extent they overlap completely with the documents I’ve got. And the reason I say that is that there may be additional documents he provided to Posey on Thimerosal or other things, because he was involved in two other vaccine safety studies. I have (inaudible: “all the”?) documents relevant to the MMR studies.

The two thimerosal studies were much larger studies and are more significant than the DeStefano MMR study in the evidence against the idea that vaccines cause autism. Given that, it’s interesting that there isn’t much on the thimerosal studies in the Thompson documents. In Thompson’s personal statement he makes no indication that the results of those studies are anything but valid or that the CDC team acted in any way other than ethically in performing those studies.

 

And then do you know if there are documents you have from Thompson that Posey does not?

I have documents that Posey does not because Thompson and I were in private correspondence.

And when you say that, are they documents that were that correspondence, or were they documents from the DeStefano days?

They are correspondence between us.

So do you have documents from the research or from his work at the CDC that Posey doesn’t have, other than the correspondence?

I don’t know, because I haven’t been through Posey’s documents yet.

One has to ask why he has not yet been through those documents? They’ve been public for some time. I put them online January 4th, nearly 3 weeks before the cruise. A journalist announced he had received the documents from Representative Posey’s office. That was in November of last year. Dr. Wakefield could have submitted his own request then. If Dr. Wakefield felt there was a possibility of evidence of misconduct in these documents, wouldn’t he have read through them at his first opportunity? In his role as creating a documentary about these events, why isn’t he jumping at the chance to add to or confirm his story?

 

That will answer a lot of my questions, actually. So, Hooker’s study came out, and again, I’m not a scientist—I’m not qualified to review or really have intelligent commentary on a statistical research study. Do you support the conclusions Hooker drew? Do you endorse them?

Do I –

It would be interesting to know what conclusions Dr. Wakefield is thinking of when he responds. There are the conclusions in the paper and there are the conclusions Dr. Hooker has stated publicly since. The last sentence of Dr. Hooker’s retracted study is “Additional research is required to better understand the relationship between MMR exposure and autism in African American males.” That’s quite different from concluding that the study shows a causal link between the MMR vaccine and autism. I believe both Dr. Wakefield and Dr. Hooker have made the latter claim publicly. It is worth noting that an epidemiological study like Hooker’s cannot, on its own, show a causal connection even if the correlation found is strong. The African American males/autism correlation in the Hooker reanalysis is far from strong.

Do you endorse the conclusions Hooker drew in his study based on the DeStefano research?

Yes, I do. I know, and I know you’re going to say it was retracted. It was retracted on the basis that the did not disclose a conflict of interest. There was absolutely no – on the initial basis, the initial rationale for the retraction was nothing to do with the scientific analysis. Which was a very simple analysis, a very simple statistical manip- analysis, which replicated what Thompson found. It was withdrawn on the basis that there was an undisclosed conflict. And that’s why it was withdrawn. There was no undisclosed conflict, and I suspect that there was pressure on the journal to withdraw [inaudible].

First, as I noted above, we aren’t entirely sure what conclusions he stands behind.

As to the retraction, Dr. Wakefield only gives part of the reason why the Hooker study was retracted. Here is the full statement from the journal:

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

The editors were concerned about the validity of the methods and analysis and “no longer have confidence in the soundness of the findings.” That’s a pretty stinging rebuke of the study itself in a retraction and completely avoided by Dr. Wakefield.

But you don’t know that.

No I don’t.

I’ve heard, and again I’m not qualified to even understand the criticism, that Hooker misunderstood how to analyze case control studies. Are you familiar with that criticism?

No I’m not. The criteria for the, if you go to the criteria for the journal, Translational Neurodegeneration, it says papers will be published on the basis of expert peer review. And only when they pass that expert peer review will they be published. The paper went expert peer review which included a statistical analysis and whether he used appropriate methodology. So it passed muster on the basis of the journal’s own rigorous criteria. That gives me cause for concern, because there was nothing in Hooker’s analysis which substantiates or supports the contention that he did not know how to analyze a case control study.

Again, look to the retraction statement by the Journal: Furthermore, post-publication peer review raised concerns about the validity of the methods and statistical analysis, therefore the Editors no longer have confidence in the soundness of the findings. Peer review specifically looking at the statistical analysis found the paper lacking.

I’ve peer reviewed many papers, and even edited the proceedings of a large conference. Some peer reviewers are more rigorous than others. We don’t know what “statistical analysis” Dr. Wakefield is claiming that the reviewer(s) performed. A referee could not replicate Dr. Hooker’s analysis as the data are not in the paper. And datasets like these are not “public use”, they are intended only for those who have shown in their application to be “qualified researchers.” Dr. Hooker should not be sharing the dataset with referees or others.

Also, one question that has been in a lot of people’s minds was who did the first peer review of the paper. Often an author can suggest to a journal potential referees and can use that to get people involved who would be favorable to the authors and/or their conclusions. I can’t say for certain that this occurred in this paper, but it is a possibility.

And of course it’s possible that the peer review was just not very rigorous. A while back a peer reviewed paper included the parenthetical comment, “should we cite the crappy … paper here?” That inappropriate comment made it past referees, editors, type setting, and proofs.

 

Would it be fair to say that you’ve analyzed the statistical work Hooker did, or –

No I didn’t. I’m not a statistician, although I’ve been involved in a lot of statistical analyses, I would not consider myself an expert in statistics and I am not qualified, certainly over and above the expert who clearly was involved in peer review of the paper, to approve or disapprove of it.

Brian Hooker is also not a statistician. Like many of us in research, Dr. Hooker has some knowledge of statistics, but his own statements (for example, “I reanalyzed the datasets using what’s in a very, very simple statistical technique”) show that he is not an expert in the field.

First, in statistics simple is not always the most valid approach. In this case it certainly is not the most valid approach. Second, and more importantly, this isn’t a statistics study. It’s an epidemiological study. In epidemiology strong studies are those that correct for factors that can lead to false conclusions. Here’s a simple example: rich people can afford healthcare and, as a result, tend to see doctors more often. They are more likely to be diagnosed for many diseases because they seek out healthcare. If a study ignores such factors—takes a “simple statistical technique” it could erroneously conclude that rich people get some diseases more than poor people. Dr. Hooker’s analysis is not only too simplistic statistically, it is too simplistic from an epidemiology standpoint.

Here are two technical critiques of the statistical analysis Dr. Hooker used:

Analysis and Reanalysis: The Controversy Behind MMR Vaccinations and Autism, part 2

Directed Acyclic Graphs and the MMR vaccine doesn’t cause autism

If you’re comfortable saying so, are you still in contact with Thompson?

No. When we – let me qualify that. I write to Thompson. Updating him on our progress. I do not anticipate a response. Because in getting him or encouraging him to get a whistleblower lawyer, his lawyer advised as any good lawyer should that he should make no further comment until a congressional hearing or the equivalent. And therefore I have not heard back from him.

If Dr. Thompson has whistleblower protection, why does he need to only comment in a congressional hearing? The vast majority of whistleblowers are not called before congressional committees.

More to the point, if Dr. Thompson felt that there was ongoing harm—that there was strong evidence of an actual connection between vaccines and autism–he would be ethically compelled to come forward and speak out. In fact, in his public statement Dr. Thompson made it very clear that parents should vaccinate:

“I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.”

And just to make sure I understand, is that what you understand what his lawyers have told him to do or what you expect his lawyers would tell him to do?

He has said something to that effect in a text. I can’t remember precisely what it is, but he said based upon my lawyer’s advice, I can now have no further contact. So it’s explicitly based on his lawyers.

I’m not surprised. You made a comment that I hadn’t heard before, that it was not true that the data Thompson released showed a protective effect for on-time MMR vaccinations in non-African American male children.

Sorry…

It’s an awkward question. So I had understood that the Thompson data showed a protective effect for on-time MMR vaccinations in non-male, non-African American children. And in your first –

Quite the opposite, quite the opposite. This is the greatest, one of the most misleading things of all, is when the head of science over Autism Speaks, Dr. Wang, was interviewed by Ronan Farrow, that was precisely what he said and what he took from the fraudulent paper. And that underlines just how deceitful the paper was, that the head of science for an organization which is the biggest autism charity in the world, gets it completely wrong when presenting in national media, that giving MMR vaccination on time appears to be protective against autism is the most egregious of all of the sins that they committed.

Dr. Wakefield appears to be misremembering the interview. The Paul Wang/Ronan Farrow interview can be found here. In discussing the DeStefano study, the one that Hooker reanalyzed, Paul Wang stated:

“If you look at children who got the vaccine on time, there is no increased risk.”

Not that there is a “protective effect” but that there is “no increased risk.”

Later in the interview, discussing a different study, Wang mentioned the “protective” effect found. A good discussion of this can be found at Forbes. Allow me to include a few paragraphs from that discussion because it makes an important point about why simplistic statistical analyses can lead to possibly false findings:

Even more surprising was the relative risk among children who had an older sibling with autism: in this smaller group, children with 2 doses of MMR were just 44% as likely to be diagnosed with autism as unvaccinated children. This statistically significant finding indicates, unexpectedly, that vaccines might actually protect children from autism.

The authors were quick to note that there are other good reasons for this apparent protective effect of vaccines: in particular, if parents of autistic children withheld vaccines from their younger children, this could explain the effect. Why? Because we know that autism has a genetic component, and that if one child has autism, his younger sibling is more likely (because they share many genes) to have autism as well. Jain and colleagues explained that if these parents withheld vaccines–because of fears spread by the anti-vaccine movement–then their children could contribute to the apparently lower rate of autism in children who were vaccinated. The authors couldn’t rule out a protective effect of vaccines, but scientifically it seems unlikely, and they wisely offered an alternative explanation.

The “protective” effect is likely an artifact of the study design and the authors acknowledged it. The first thing a good researcher does when she/he finds a result is to challenge it, test it. “If I do a more in-depth analysis, does this finding hold up?” “Is there an alternate explanation that could be causing this and make this result spurious?” Simple is not elegant, as Dr. Hooker asserts. Simple is the first step. And if you don’t take the next steps, your study is weak and your conclusions more likely to be wrong.

This may also be in the letter you told me to look up, but the destruction of documents—are you aware of specific documents that were destroyed, or types of documents that were destroyed? Or was it just an allegation that documents were destroyed?

Well, what I have are all of the serial outputs of the data covering that period during which the documents were destroyed, and what was quite clear was that the data tables showing highly significant association between autism and vaccination [inaudible: “on time”?] were there before the alleged destruction of documents and were gone afterwards. In other words, the documentary evidence provided by Thompson confirms exactly what he said, that data were destroyed.

This is the story made public in the “garbage can quote” read into the Congressional record by Representative Bill Posey. That can be found in the statement by William Thompson included with the document provided by the Representative to me (and made public by me). Here’s the end key paragraph quoted by Representative Posey. Note that the last line was not read into the record:

However, because I assumed this was illegal and would violate both FOIA laws and DOJ requests, I kept hard copies of all my documents in my office and I retained all the associated computer files. This included all the Word files (agendas and manuscript drafts), Excel files with analysis and results, and SAS files that I used to generate the statistical findings. I also kept all my written notes from meetings. All the associated MMR-Autism Study computer files have been retained on the Immunization Safety Office computer servers since the inception of the study and they continue to reside there today [emphasis added].

Emphasis added. All the files have been retained. If printouts were shredded but the files kept, what’s the controversy? Dr. Hooker and Dr. Wakefield appear to have been claiming that Hooker recreated the CDC team’s analysis solely using the dataset maintained by the CDC and provided upon request to qualified researchers. So, again, what data was deleted?

One might think, well personal notes were shredded and those could show actions that indicate wrongdoing on the part of the CDC team. We don’t know what notes the other researchers retained. But we do have William Thompson’s notes—notes by the person most likely to record wrong doing. We don’t have statements in his personal notes–taken while the study was ongoing–that suggest fraud. In fact one of the few notes that goes to the mindset of the research team states, “we all have good intentions.”

I don’t understand what that means in this context. You have a report of what’s on the servers? Or you have a report of what was in file cabinets? Or you have –

No, I have printouts, or well, sorry, I have email documents. These are documents generated in Word with a date of creation, so that you can confirm that those documents were created contemporaneously with when Thompson said they were created. And they reflect meetings that took place on a serial basis every month, or twice monthly, between the group, the coauthors for that paper. And in September 2002, when Thompson alleges these documents were destroyed, then the African American effect, for example, and the isolated autism effect, were there. And then afterwards, they were completely gone. So that would support Thompson’s contention that documents were destroyed.

The story is much more mundane than Dr. Wakefield is implying here. What is clear in these documents is that this timeframe–around Sept. 2002–is when the research phase of this project ended. Dr. Wakefield tells us, “And then afterwards, they were completely gone.” When you go through the documents you see that after September 2002 there are pretty much no more research group meetings. There were a handful of meetings after this, but the analysis was over and the figures basically finalized. A preliminary draft of the study manuscript is dated Oct. 2002. So the idea that the team met to discuss what to archive and what to shred, and that the figures were finalized about this time is not only not surprising, it’s expected.

And this is where it’s good to have the actual documents. Dr. Wakefield did not share the documents he had, only quotes and screenshots. Bits that supported the arguments he was making. When we see the actual documents we see a different story. When I put up my own analysis of the documents, I made the documents publicly available so people could form their own opinions. From what I can see Dr. Wakefield did not do this.

Speaking of mundane, yes the documents “reflect meeting that took place on a serial basis” as Dr. Wakefield states. In one folder there are about 500 pages of agendas, tables and graphs for those meetings. And when one goes through these documents one finds they are very redundant. The same talking points, the same graphs and tables meeting after meeting. We are asked to be shocked that the CDC team discarded documents. I’ve posed this question publicly–what in those documents needed to be kept? Do we really need multiple researchers archiving every meeting agenda? The answer is simple: no, we don’t. I not only expect them to discard much of this paperwork, I hope they aren’t hanging on to all this paperwork for every project they work on.

I still don’t understand quite what this means. So there was a word document, and in that document, it refers to the African American effect, the isolated autism effect –

It shows the data. It shows the data table.

And in later versions of that document, those tables are gone?

I’ll give you an example. All of the data are contained in a table called Table 5. That table is there in September and it’s gone in October. Never to be seen again.

The last one of these documents– that has “table 5” is, as Dr. Wakefield says, in September 2005. So is Table 8, which includes things like variables “M_AGEC11” and “B_MULTB.” Why is that important? Because those are variable names important to the researchers but were obviously not intended for the final study. The fact that Table 8 (or table 5 for that matter) got cut isn’t a smoking gun, just evidence that these were preliminary tables and that study hit the turning point of finalization.

Most of the attention in this discussion goes to the African American effect. Let’s consider the “isolated autism” effect. “Isolated” autism means autism without other disabilities. What happened to that? The CDC team published it. They narrowed it down to autism without MR, but it’s basically the same thing as “isolated.” They also showed that in the simple analysis (the sort that Dr. Hooker claims is “elegant”) there is an apparent association, but that association disappears when one does a more rigorous analysis. Aside from debunking the controversy over “isolated” autism, this serves as another example of why simple isn’t the best.

But the data that was used to create Table 5 – was that destroyed?

Very good question, was the data destroyed. No. No it was not. Because it was not – it was intended to be destroyed. All of the – it was Thompson’s claim that all of the hard copy documents, and all of the computer files, relevant to this paper were targeted for destruction. The original data tables or data files from which the tables were generated were preserved by Thompson and are available and can be reconstructed in order to generate the information. As an example, the data tables – the excel – sorry, they were SAS spreadsheets – provided to Hooker, by which he then did an analysis.

Personally, I want to check the source every time Dr. Wakefield or Dr. Hooker claim to be speaking for William Thompson. Thompson has made very few public comments, plus a few conversations secretly recorded by Brian Hooker and since released by Hooker. Given this, let’s ask ourselves: instead of Dr. Wakefield giving his interpretation of what Dr. Thompson said, why not just quote Thompson? For example, consider the very strong claim “it was Thompson’s claim that all of the hard copy documents, and all of the computer files, relevant to this paper were targeted for destruction.” Now Thompson’s statement, “All the associated MMR-Autism Study computer files have been retained on the Immunization Safety Office computer servers since the inception of the study and they continue to reside there today.”

We don’t know what hard copy documents were kept by the other authors. Or what notes were in notebooks they kept. We hear that they discarded some, but we don’t know that they may have kept. Also, consider this: if “all the hard copy documents” were “targeted for destruction” why meet to decide which documents to shred if the decision is to shred them all? Is it so they can watch everyone discard documents? If so, consider this: we know from Thompson’s own statements that one of the MMR study leaders was missing from the “garbage can” meeting. The story just doesn’t make sense.

We should address the question of discarding research documents: is it unethical? I’ve been a researcher for 30 years. It is common practice to periodically decide what documents to keep in my office, which to archive to a warehouse and which to discard. When I would clear out documents my company would provide me large confidential bins. They look like “garbage cans” except the lid is locked and the only access is through a slot in the top so people can’t fish documents out. After these bins are collected they are sent to a confidential shredder. [Colin: Although I’m not a scientist, I’ve seen similar procedures in very many offices where confidential documents like legal or financial files are used.] I would expect the CDC to have a similar procedure. A researcher keeps the documents that are required to recreate the final analysis and, in my case, determine dates of invention.

http://www.lbmedwaste.com/products_confidential_document.html
Bins like these are used to dispose of confidential documents in many offices, to protect privacy when clearing out old hard copies containing things like social security numbers or health records.

As long as we are talking about the few public statements Dr. Thompson has made, allow me to repeat this one:

I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.

So that data exists, so far as you know, only in Thompson’s files and not in the CDC’s main files, wherever those may be?

According to Thompson, all of those – he was the only one who preserved all of those records. Beyond that, I do not know the infrastructure of the CDC’s filing system, so I don’t know – I think I’ve probably reached the limit of my knowledge about that. Is there some sort of backup system that retains the original SAS files, I don’t know [inaudible].

“I don’t know.” I believe he should. I see it as ironic that Dr. Wakefield claims to speak for Dr. Thompson (“According to Thompson”) while having not read all the documents Dr. Thompson released to Representative Posey. As I’ve already noted above, Dr. Thompson made it explicitly clear that all the associated MMR-Autism Study computer files have been retained on the Immunization Safety Office computer servers since the inception of the study and they continue to reside there today. At the very least, the raw data exist. Clearly, since Dr. Hooker used those data for his analysis. Also, I’d be curious how Dr. Wakefield knows that Thompson “was the only one who preserved all of those records”. We know that some documents were discarded, but we don’t know what was kept by the other team members.

And then are you referring to statements that Thompson made that have been released, or statements that are still confidential regarding his allegation that those files were deleted?

Both. Both. So his statement to Bill Posey and other documents that I have obtained that are in the documentary. Documents which are not publicly released.

If by the “statement to Bill Posey” Dr. Wakefield means the full statement that Representative Posey excerpted in his House speech, that is indeed publicly released. I released the documents Representative Posey’s office provided to me. I discussed the full statement here.

The full statement is much longer than the excerpts that Representative Posey read. It includes the statement:

“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.”

Emphasis added. I’ll be curious to see if this statement (and others that are problematic for Dr. Wakefield’s story) appear in the documentary.

You mentioned that you’ve analyzed the notes, and that you know who the coauthor was who made some handwritten annotations. Would you disclose who that coauthor is?

No.

Would you disclose how you did the analysis?

No.

Will that be in the documentary?

Yes.

Both the type of analysis and the name of the author?

As yet undecided. [Inaudible: “As yet”?] a matter of discussion.

I was talking to Nick Begich earlier as he dropped these off [pointing to DVDs], and he kind of referred to the breadth of opinions expressed at the conference. And some – I wouldn’t say alarm, but some surprise at some of the views that have been expressed here. And I know that you haven’t been at all the various panels that haven’t involved vaccines or autism, but I think you’ve heard some relatively wild statements. Would you be comfortable establishing a line at which you feel it’s irresponsible to speculate about the cause of autism, or about conspiracies related to medical care?

So sorry, is there a line –

At which you’d object to some of the speculation that’s gone on at the conference.

My reason for coming, or what persuaded me to come, was that Jeffrey Smith was presenting. And Sherri Tenpenny. The other people I don’t know. I’ve met one other person one time. So I know nothing about any of the other people. But I’ve been someone who’s followed Jeffrey Smith for a long time. And I think his approach to his subject is very thorough, is informed, and very valuable. And so every time I get an opportunity to listen to him then I’m very grateful. Sherri similarly. A great deal of knowledge and understanding of the subject. The others, as you say I haven’t been to the talks. I don’t know what their discussions were about.

I am less interested in his “reason for coming” as for why he didn’t consider association with many speakers a reason for not coming.

I’m thinking for example of Len Horowitz’s discussion of the 528 frequency –

Yeah, I didn’t hear that. [Inaudible: “I wasn’t there”?] I just don’t know. So no, I just don’t know. I wasn’t there. So it would be unfair of me to comment on [inaudible].

I heard you speak in Austin, when we were still living there, at an Autism Speaks conference. [I was mistaken; it was an Autism Trust event called the “Give Autism a Chance Summit.”] You were MCing, I think it was Autism Speaks, at the music center downtown in Austin. There were people on the stage like Dr. Kriegsman, and I can’t think of the other guy’s name, who was instructing parents to turn off their routers and their cell phones so the EM waves wouldn’t hurt their autistic children. And I was hoping at the time you would comment to the parents in the room as to whether you thought that was reasonable advice or not, and you haven’t made a statement on it as far as I know. Is that kind of advice something you think is reasonable?

I don’t – if I do not know the subject, I’m not going to give advice. I’m just not going to do it. It’s irresponsible. I’m not going to give advice that could even be potentially construed as medical if I have not done a thorough analysis of the data. Now that said, I keep my mind open to the possibility that there are co-factors that may influence autism risk [inaudible]. I don’t know what those co-factors are. But I’m never going to advise people on what to do based on something about which I know nothing. I’m going to confine myself to the things which I know and I’ve worked on and I’ve read and understood. And where I don’t know I’m going to say I don’t know. If someone has a competing theory of autism, OK, let them talk about it.

One of the reasons my wife and I came to this country is that has a constitution that includes the values we respect. And god forbid that people should be censored or excluded from expressing opinions. Just like the journalists on this trip feeling threatened, that they couldn’t be in discussions, that’s not right, that’s not the way I operate. I encourage dissent because in the end, it’s only through the presentation of competing arguments that truth is going to win. Just in the same way that I talked to you about how it was not our job to censor the parents’ story just because others found it inconvenient or didn’t believe it. It’s not my job to censor other people expressing opinions that may not concur with my own.

I find this highly ironic given the legal threats Dr. Wakefield has made to journalists. He’s even brought suit multiple times against a journalist. A judge in one case referred to Dr. Wakefield’s use of litigation “as a weapon in his attempts to close down discussion and debate over an important public issue.”

Do you feel that given your high profile, your presence might be an endorsement, or at least perceived that way by people who don’t have a chance to talk to you personally?

Well if that is the case, then I should shut myself in a cave on a high mountain, become a hermit. And that’s not going to happen because that’s not the way in which knowledge is going to spread. If people take it as that then it is because they want to take it as that. Because that’s the spin that’s placed on it.

I wanted to ask just one more question.

Go, one more question.

And feel free not to answer. What evidence would change your mind, about a link between autism and vaccines?

What evidence would change my mind… [long pause] What is my position, firstly let’s define what my position is. That’s very very important. Vaccination should operate from a position of an abundance of caution. What you’re doing is you’re taking healthy children and exposing them to a risk or a potential risk. And you’re doing it on the background of the available data on the safety and efficacy of that vaccine. It’s not like you’re taking patients with end-stage cancer, where you say, “Look, you’ve got a fifty percent chance of dying and a fifty percent chance of living, and there may be some benefit but we don’t know.” You’re taking entirely healthy children and you’re giving them an exposure, which incurs a risk. And the risks are all spelled out in the product insert.

So my position, and the position that medicine should be in, is that you operate from an abundance of caution. If there is even a possible risk of harm, then you do everything in your power to either exclude that risk or stop the vaccination policy. First do no harm.

So my position is not that it’s black and white. It is that you operate from an abundance of caution. You have to be very very clear that what you are doing has a minimal, an absolutely minimal risk, for the maximum benefit.

The interesting thing here is the for years the narrative that I recall from his supporters was that Dr. Wakefield didn’t say that vaccines cause autism. He was just posing questions.

That said, see what Dr. Wakefield has done here? He’s framed the question as though there is only one source of risk–vaccinating (and implies falsely that one of those risks is autism). He doesn’t even approach the question of the risk in not vaccinating and leaving one’s self vulnerable to disease. Ignoring that is hardly an “abundance of caution.” Quite the opposite, it’s an abundance of irresponsibility in my opinion.

The positions and the rhetoric that you’ve taken at this conference make it pretty clear you feel that there is extremely good reason to believe that the MMR vaccine in particular, and possibly vaccines in general, and possibly GMOs as well, have a causative link to autism.

Yes.

What would change your mind?

That is because I’ve sat in this field now for twenty years, and nothing has persuaded me that the science is wrong. And what now convinces me that there is a real cause for concern is William Thompson coming forward and saying that a hypothesis that I put forward in the year 2000 is proven to be correct by the year 2001 and was kept concealed for 13 years. How would you feel in that position? Would you feel that it reaffirmed your concern that the parents’ story was right? Or would you think, well, we can dismiss that because – no. It is quite clear that there is a problem they have covered up. So it makes me feel more strongly than ever that we need good, independent science—and I mean independent, independent of the CDC, independent of influence by government or the pharmaceutical industry—that gives us the answers. Will we ever get that? No. We will not get that. Why? Because the system is so distorted, and that’s very very sad. And I’m a scientist, I’ve published 140 papers and I’ve never committed fraud in my life. And I’ve published papers which suggest my hypotheses is wrong. Very few people do that. I publish them. I publish papers – and you can look them up, in the Journal of Medical Virology, saying “we do not find this virus in these tissues.” Despite that being our hypothesis [inaudible]. So I’m perfectly open to the counter-argument. But nothing so far has persuaded me that there isn’t a link, and Thompson’s revelations have reaffirmed to me that there is a link. There is no question, there is a link, they’ve found it. [inaudible] So there we are.

Let’s take on the most important statement here first:

“But nothing so far has persuaded me that there isn’t a link, and Thompson’s revelations have reaffirmed to me that there is a link. There is no question, there is a link, they’ve found it. [inaudible] So there we are.”

But that is not what Thompson says. Again, I’ll quote him directly:

“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.”

 Thompson doesn’t say there is a link. He doesn’t say “without question.” So, there we are.

Also, it’s worth noting that the above response is worthy of a politician. Ask yourself, did Dr. Wakefield ever answer the question (what would change your mind)? If so, I don’t see it.

If I may, let me discuss the general question of vaccines and autism. I’ve taken this very seriously from the start. This is personal to me in a way that it will never be to Andrew Wakefield as I have an autistic child. I am also a researcher, a Ph.D. I’ve immersed myself in the literature—especially that which claims to show a link between vaccines and autism.

Actually it is Dr. Wakefield’s science, and that of many others who purport to show a link, that showed me that there is no substance to the claim of vaccines being linked to autism. And from that I can say this: it isn’t a question of refuting that claim, it’s a matter of the fact that the claim just isn’t strong at all to begin with.

For example, look at Dr. Wakefield’s conclusion here “Thompson’s revelations have reaffirmed to me that there is a link.” He ignores the bulk of even Hooker’s analysis (most groups show no increased risk of autism) and clings to one small subgroup. OK, that’s a weak stance on his part, but it gets worse. He claims that subgroup result shows not only a correlation, but causation. Even though such a study as this cannot show causation. Even though Thompson himself says this finding “…does not mean that there was a true association.”

There is a large body of evidence, epidemiological and biological, that says that the Wakefield MMR/Autism hypothesis is wrong. But the fact is that the Wakefield MMR/autism hypothesis was never very strong. It’s built on arguments such as “Thompson’s revelations have reaffirmed to me that there is a link.” And, ironically, Wakefield’s work is some of the strongest in the “vaccines cause autism” portfolio.

This post has been edited to restore formatting to the links in Carey’s comments.

A look at the “Garbage Can Quote” in full context

6 Jan

Last summer Representative Bill Posey read a statement in the House regarding William Thompson of the CDC. In it was a quote from a statement that quickly became known as the “garbage can quote”. The statement basically said that the CDC got rid of a number of documents related to one of their MMR studies, that William Thompson thought this was inappropriate, and that he had retained copies of the documents.

I obtained copies of the documents provided to Representative Posey’s office, posted them online and discussed them here at Left Brain/Right Brain.

Here is the “garbage can quote” as discussed at Emily Willingham’s column at Forbes.com last summer.

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

The statement in its entirety is in the package provided by Representative Posey’s office, so I was able to read it in context. Let’s take a quick look, shall we?

12. On June 28, 2002, all coauthors met and examined subgroup analyses by RACE for Whites and Blacks. (See page 17 in the Agendas Attachment and handout that includes Table 5).

13. In the Excel File named “describe_results_2002_0702.xls”, Table 7 shows the RACE analyses that I had run using ONLY the BIRTH CERTIFICATE Sample — the unadjusted RACE effect was statistically significant. (OR=1.51, [95%CI 1.02 – 2.24]). At the bottom of Table 7, it also shows that for the NON-BIRTH Certificate Sample, the adjusted RACE effect statistically significance was HUGE. (OR=2.94 [95%CI 1.48 – 5.81). That is the main reason why we decided to report the RACE effects for ONLY the BIRTH Certificate Sample.

14. In the Excel File named “describe_results_2002_0801.xls”, I split Table 7 into three different Tables (Table 7a, Table 7b, and Table 7c) to further investigate the RACE subgroup analyses.

15. All the coauthors met and decided sometime between August 2002 and September 2002 not to report any RACE effects for the paper.

16. Sometime soon after the meeting where we decided to exclude reporting any RACE effects, also between August 2002 and September 2002, the coauthors scheduled a meeting to destroy documents related to the study. Dr. Coleen Boyle was not present at the meeting even though she was involved in scheduling that meeting. The remaining 4 coauthors all met and brought a big garbage can into the meeting room and reviewed and went through all our hard copy documents that we thought we should discard and put them in the large garbage can. However, because I assumed this was illegal and would violate both FOIA laws and DOJ requests, I kept hard copies of all my documents in my office and I retained all the associated computer files. This included all the Word files (agendas and manuscript drafts), Excel files with analysis and results, and SAS files that I used to generate the statistical findings. I also kept all my written notes from meetings. All the associated MMR-Autism Study computer files have been retained on the Immunization Safety Office computer servers since the inception of the
study and they continue to reside there today.

Emphasis added to highlight text that appears to have been left out in the speech by Representative Posey.

Note that the last line in what was quoted by Representative Posey, “I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper”, was in the conclusion. Which was about 14 paragraphs after the rest of the text he quoted. I don’t think that is significant, but it’s worth noting.

I find a few things interesting in this. First, the omission of the sentence about Coleen Boyle (Dr. Coleen Boyle was not present at the meeting even though she was involved in scheduling that meeting.) Without that the paragraph reads as though Thompson was not present for the meeting. Instead, we now see that he was one of the “four remaining authors”. As such, why doesn’t he comment on the criteria for shredding documents? Second, it is very interesting that Coleen Boyle wasn’t there. Wakefield and Hooker have specifically targeted her in their attacks, and the fact that she wasn’t participating in this meeting goes against their narrative. If for no other reason that we don’t have any idea now what Ms. Boyle kept or didn’t keep.

A more important ommission, dare I say a significant omission: “All the associated MMR-Autism Study computer files have been retained on the Immunization Safety Office computer servers since the inception of the study and they continue to reside there today.”

Many people have claimed that the “garbage can” quote means that the data were deleted. Well, that’s not what Thompson said. It’s also a clearly false claim as Brian Hooker was able to obtain the data for his own version of the analysis. Here’s what Dan Olmsted of the Age of Autism blog had to say just a few days ago (he’s listing his “true” conspiracies) “The conspiracy by William Thompson and his colleagues dumping raw data into a wastebasket after they had twisted it into obscuring a link between the MMR and autism.”

It’s hard to dump raw computer data into a wastebasket, Dan. Delete, sure. Well, unless you are at a government lab that mandates backups of important raw data. Leaving that aside, data weren’t dumped. It appears that they discarded a huge amount of redundant paper based on what Thompson held on to. Most if not all of which could clearly be sent to a confidential shredder without any question of ethical lapse.

Another line of that statement also is of importance to note. Specifically because a lot of people are claiming that Thompson has said that the CDC team found that the MMR vaccine causes autism. He doesn’t:

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.

Emphasis added.

As to those who think I am skipping over the really important statements like “the adjusted race effect statistical significance was huge”. Let’s consider that a moment. One does adjustments, say with data from birth certificates, specifically in order to make sure that one doesn’t announce a possible association that is spurious. Beyond that, what Thompson doesn’t do is say, “here’s the scientific arguments that were given to not report this result and here is why I disagree.” Instead we are left to assume that the reason was to hide the result. If so, back it up. Where in his contemporary notes does he say, “they are doing this and it is wrong”. He says he’s not comfortable not presenting it, but he also says they all have “good intentions”.

But let’s get back to what the statement does say, rather than what it doesn’t.

Data were not deleted.

Even if the race effect isn’t considered spurious, it does not mean that there is a true association between the MMR and autism.

And some people are telling you that Thompson said the opposite.

Edit to add:

I am in no way suggesting that Representative Posey edited this statement to be manipulative. He may not have even been the one who wrote his statement in the House. But I do think that there is something to learn from the ommitted parts.


By Matt Carey

The William Thompson Documents. There’s no whistle to blow.

4 Jan

For those unfamiliar with the story of William Thompson, here’s a brief introduction. William Thompson is a CDC researcher who has worked on vaccine/autism studies. About 2 years ago he approached Brian Hooker (an autism parent and very vocal advocate for the idea that vaccines cause autism) stating that a statistically significant result was not only left out of an old study but that this represented not a scientific decision, but misconduct on the part of the CDC. It is worth noting that “statistically significant” is not the same as “proof of a connection”. Brian Hooker published his own analysis (incorrectly claimed as being the same as the CDC analysis method) in a now retracted paper. The result he presented was that there was an apparent increased risk of autism for one small subset of the study population: African American males, who were vaccinated not on schedule but before age 3.

There are some questions, of course, that this raises. Is this result very strong? Does the lack of inclusion in the paper represent scientific fraud or a legitimate scientific decision?

A few epidemiologists and other scientists have chimed in (for example here, here and here) and stated that the result was very likely spurious and that Hooker’s approach is somewhat flawed and definitely overplayed.

In fact, Brian Hooker’s paper was more of a publicity event than a scientific inquiry. When the paper was published, Brian Hooker and Andrew Wakefield released a video. It is difficult to describe just how bad this video was but here are a two examples. Wakefield tried to put forth the inflammatory claim that the CDC’s vaccine program was a new Tuskegee experiment. Which is to say that the CDC are intentionally allowing African Americans to become autistic due to vaccines as part of some sort of study. Second, according to Andrew Wakefield, the CDC team is so evil that they are worse than Hitler, Pol Pot and Stalin. =Mr Wakefield’s logic being that those dictators were sincere and the CDC team were not. No, really, Hitler was sincere per Wakefield.

In a series of phone calls between Thompson and Hooker (secretly taped by Hooker and released without Thompson’s permission), we find that Thompson was very interested in testifying before congress. It turns out that William Thompson kept much (if not all) of the paperwork involved in this study and, probably at least in part motivated by the hope for a hearing, passed these along to a member of Congress: Bill Posey. It has been claimed that this cache of documents numbers as many as 100,000 pages. Many have hoped that these documents will expose fraud by the CDC. (They don’t)

Congressman Posey released the documents to a journalist recently and, given that they are now in the public domain, Dorit Reiss and I requested that they be made available to us as well. Mr. Posey’s office graciously granted our request and I have spent some time going through them.

For those hoping for an exciting look into CDC malfeasance, sorry to disappoint you. Not only is it not present here, but these documents are very mundane and repetitive. Many people seem to think there will be evidence that the CDC are covering up. No “Vaccines cause autism! How do we cover this up”. Nothing like it. Wakefield and Hooker have already cherry picked–and misrepresented–whatever they could to “best” make their case.

For more introduction, I point you to these articles as a start:

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

Did a high ranking whistleblower really reveal that the CDC covered up proof that vaccines cause autism in African-American boys?
The “CDC whistleblower saga”: Updates, backlash, and (I hope) a wrap-up
Brian Hooker and Andrew Wakefield accuse the CDC of scientific fraud. Irony meters everywhere explode.

Given that long introduction, what is in the documents? Well, there’s about 1000 pages, not the claimed 100,000. Documents provided by Mr. Thompson and, also, documents that submitted as part of the complaint that Wakefield and Hooker filed with HHS were included in the zip file. Which is convenient as I had submitted a FOIA request for those.

There are multiple drafts of the analysis plan. Analysis Plan is the same thing as the “protocol” that Wakefield and Hooker claim was changed after the first race data were analyzed. And the fact that we have the revisions gives us the chance to check two of the fundamental claims behind the Wakefield/Hooker “fraud” charge against CDC. (1) Did the CDC plan to look at race as an exposure variable? Wakefield and Hooker are claiming (although they use different words) this is what the CDC was doing. This is different from using race as a control variable. (2) Did CDC add the birth certificate analysis after the first race analysis was done, in order to dilute the effect?

No. Very clearly no. I’ve covered (2) already based on information Wakefield and Hooker made available. The final analysis plan was dated Sept.5, the first race analysis wasn’t until late October or early November. And we see the same in these documents.

But now we have new information that answers (1). Here is what appears to be the first draft of the analysis plan. And here is a capture of a very important part:

First Draft Analysis plan segment 1

Note that this draft analysis plan is from April 3, 2001. Well before the final version, the “protocol”, which was September 5. More importantly, this is a long time before a race analysis was started. But even more, notice how there’s an annotation “I would include race as a covariate, not as an exposure variable.” That’s critical–they decided against using race as an exposure variable from the start. Before they did a race analysis. Another point: they were already planning on using birth certificate data right from the start.

William Thompson certainly should have known this, it’s very probable that he did know this. Wakefield and Hooker likely knew this. They showed documents from this collection in their video and elsewhere. But they told us the opposite.

Whether they knew or not, they were wrong. Wildly irresponsibly wrong.

Ever wonder why they didn’t make documents public? We can’t tell if Hooker and Wakefield had all the Thompson documents, but we know they had some. While they cry out for transparency, they were carefully guarding information in order to craft the story they wanted told. The full documents tell a different story.

Let me put this more simply: if Wakefield and Hooker worked for me they would be fired for just their handling of the Thompson story (of course, they would have been fired years ago for many other causes, but promoting this sort of misinformation is simply wrong.)

Also in that same directory appears to be the first draft of the paper (A000071.PDF), with William Thompson as first author. I find it interesting that Thompson is first author there as later it would be Frank DeStefano who would be first author of the published study.

There are also meeting notes. Lots of meeting notes. Here’s the first batch, as near as I can tell. Meetings were held every month or two.

Now is a good time to address the “garbage can” quote. Congressman Posey read a statement from William Thompson into the congressional record. Emily Willingham discussed this in A Congressman, A CDC Whisteblower And An Autism Tempest In A Trashcan. On the other side, here’s an article by Jon Rappoport Bombshell: CDC destroyed vaccine documents, Congressman reveals Bombshell: CDC destroyed vaccine documents, Congressman reveals; CDC whistleblower case is back.

Here’s the thing–there’s zero “bombshell” involved in putting these documents into a confidential bin for shredding/recycling. There’s no reason to keep all these revisions of the analysis plan, all these meeting notes, all this redundant material. I hope people at CDC are not keeping all this paper. Beyond that, the rules are that they have to keep enough information to recreate the study. Aside from the fact that all these meeting notes are not required for that, Brian Hooker proved that requirement was met when he claimed to have done exactly that–recreated the study.

Mr. Thompson also provided a file with ALL Agendas for mmr autism meetings with written interpretation. Which is to say Thompson added his own annotations (purple pen) to the agendas.

Here’s an example of his annotations. And a great example of trying to make data fit a story. Thompson appears to be trying to support the idea that the CDC team changed the protocol to include the birth certificate analysis in response to analyzing the race data:

Race examined before final protocol

The implication that the race analysis and had somehow influenced the final protocol (as Wakefield and Hooker have claimed and this comment appears to support) is just plain wrong. First, as we have already seen, the birth certificate analysis was included from first draft of the analysis plan, in April 2001. That’s four months before this meeting note. Second, the so-called “race effect” isn’t seen in this meeting note. In fact, we see the opposite: “not statistically associated with case/control variable”.

From the phone conversations between Brian Hooker and William Thompson (secretly taped by Hooker), we have found that Thompson was very interested in participating in a congressional hearing. Hooker and his colleagues had been involved in arranging a previous congressional hearing on autism. Frankly it appears to me as though Thompson was involved in a bit of a quid pro quo: Thompson coaching Hooker in ways to spread fear about vaccines in exchange for a chance to be involved in a hearing. Which begs the question: why no hearing based on all that Thompson has laid out?

In case it isn’t already abundantly clear: there’s no hearing because there is no reason for a hearing. There’s no evidence of fraud. Many of the reasons given by Wakefield and Hooker to call this fraud are, well, just flat out wrong. Contradicted by the evidence. For those hoping that Thompson’s personal notes would show some evidence of a cover up, here they are mmr autism study 2001-2002 hand written notes.

Ah, one will say, what about the finding of an association between the MMR and autism for African American boys vaccinated late (between 18 months and 36 months)? Why wasn’t that included in the published paper or public presentations? The reasons given by Thompson/Hooker/Wakefield don’t hold water as I’ve shown. So, what was the scientific reason for not including this result in the paper? Many online writers have discussed how weak this result is; how it is a spurious result. But I’d like to know the reasoning at the time behind the CDC decision to leave this out. As a community member–an autism parent–I’d like to see all the results and understand the reasons why certain results are spurious. Of course it is easy to say now, but leaving this out of the public’s eye was a mistake. It gave Thompson, Hooker and Wakefield the chance to cherry pick, hide information and craft a story that has been very damaging to the autism communities and to public health.

The first thing I did when I heard about this story was email a few epidemiologists I know and point this story out and ask them if they had the data to address the question raised. I no longer feel this way. Why should the autism communities spend precious funds and researcher time every time Andrew Wakefield (Time Magazine’s #1 on their list of great science frauds) comes up with a new story? Especially now that we know the story was built on lies. But consider this: Wakefield and Hooker have not been calling for more research. Instead they are calling for a congressional hearing. If you watched any part of the previous hearings you know they are political theater and have done nothing (NOTHING) to help make a better life for autistics. They have done nothing except provide video and blog fodder for those promoting the failed idea that vaccines cause autism.

Also, consider this: before Thompson Wakefield and Hooker didn’t talk about the issues of racial/ethnic minorities. For the most part, the entire “autism is caused by vaccines” community have ignored minority communities. Why? Because they are a clear example that the vaccine hypothesis is a failure. Prevalence estimates for racial/ethnic minority groups have been typically much lower than for Caucasians (Hispanics are diagnosed at a rate of 1/3 that of Caucasians in California. And this has been consistent for over 10 years.) This presents a huge problem for the likes of Hooker and Wakefield. If vaccines are a major cause of autism, why do minority groups have such low prevalences? If they were honest about their own beliefs, they would be calling for a study into the “protective” effect for minorities. But they don’t. More importantly, if they were real autism advocates they would be calling for better diagnosis, better awareness, better services for these under served communities. Instead they have just ignored these minority communities. That is, until they could use them as part of their campaign against vaccines.

And they still aren’t calling for better services better diagnosis in these underserved groups. Instead they are just trying to recruit as many parents as they into the vaccines-cause-autism camp. Imagine being convinced, wrongly, that you participated in injuring your own child. The charlatans who prey on our community with fake–and sometimes abusive–therapies rely on the vaccine/autism idea for the majority of their business.

The vaccines-cause-autism story is built on lies and it is very damaging. There has been nothing since the Kanner/Bettleheim “refrigerator parent” idea that has caused so much damage to our community. And that is the real story here. A group of people perpetuating a failed idea by carefully crafting a story.

The Zip file provided to me by Representative Posey’s office is at this DropBox link
https://www.dropbox.com/sh/jxtr06s5ddc82s7/AADaZvp7yu_daBhbuZwMfQy4a?dl=0

Again, I am grateful to Representative Posey and his staff for providing these files to me.


By Matt Carey

Comment on study: Early exposure to the combined measles-mumps-rubella vaccine and thimerosal-containing vaccines and risk of autism spectrum disorder

23 Nov

Missed this one from earlier this year. A study that looked at both MMR uptake and thimerosal exposure from infant vaccines. Guess what? “No convincing evidence was found in this study that MMR vaccination and increasing thimerosal dose were associated with an increased risk of ASD onset”

Again.

The abstract is below.

Why do I suspect that this is not included on “vaccine information” websites like the so-called “National Vaccine Information Center”, or “Dr. Bob’s” new site? Oh, because it doesn’t scare parents about vaccines, that’s why. And they can’t even blame the CDC or drug manufacturers for putting out a biased study (well, they can, they will, because they always do).

This study was done by Japanese academics. I’m sure some connection to Big Pharma will be produced to discount the fact that this study tells us what every other actual study on MMR and thimerosal and autism has said.

Early exposure to the combined measles-mumps-rubella vaccine and thimerosal-containing vaccines and risk of autism spectrum disorder.
Uno Y1, Uchiyama T2, Kurosawa M3, Aleksic B4, Ozaki N5.
Author information
Abstract
OBJECTIVE:
This case-control study investigated the relationship between the risk of Autism Spectrum Disorder (ASD) onset, and early exposure to the combined Measles-Mumps-Rubella (MMR) vaccine and thimerosal consumption measured from vaccinations in the highly genetically homogenous Japanese population.

METHODS:
Vaccination histories at 1, 3, 6, 12, 18, 24, and 36 months from birth were investigated in ASD cases (189 samples), and controls (224 samples) matching age and sex in each case. Crude odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated to determine relationship between MMR vaccination and ASD. The differences in mean values of the thimerosal dosage between cases and controls were analyzed using an unpaired t-test. MMR vaccination and thimerosal dosage were also investigated using a conditional multiple-regression model.

RESULTS:
There were no significant differences in MMR vaccination and thimerosal dosage between cases and controls at any age. Furthermore, the ORs (95% CIs) of MMR vaccination and thimerosal dosage associated with ASD in the conditional multiple regression model were, respectively, 0.875 (0.345-2.222) and 1.205 (0.862-1.683) at age 18 months, 0.724 (0.421-1.243) and 1.343 (0.997-1.808) at 24 months, and 1.040 (0.648-1.668) and 0.844 (0.632-1.128) at 36 months. Thus, there were no significant differences.

CONCLUSIONS:
No convincing evidence was found in this study that MMR vaccination and increasing thimerosal dose were associated with an increased risk of ASD onset.

Copyright © 2014 Elsevier Ltd. All rights reserved.

KEYWORDS:
Autism Spectrum Disorder; Case–control study; Environmental factors; Measles–Mumps–Rubella vaccine; Risk factor; Thimerosal


By Matt Carey

Mr. Kennedy, if you know the science, why did you claim that the MMR vaccine contains mercury?

16 Nov

Robert Kennedy (son of Robert F. Kennedy) has been focused on reducing mercury exposure for some time. His advocacy against mercury led him to focus on vaccines (infant vaccines used to contain a mercury compound as a preservative). And, the main argument against mercury in vaccines is the (now totally failed) idea that mercury in vaccines causes autism.

It’s important to keep that autism is not his priority. It’s his tool to allege dangers of vaccines. He’s not out to help us out, but instead to use us to help him.

Add to this that he’s a lawyer, not a scientist and he’s from a very political family. Three are lawyers and politicians actually understand science. Mr Kennedy claims he is in that number (he’s “rabidly pro-science”), but in reality he either doesn’t understand the science or the facts are just be a political tool for him.

That Mr. Kennedy feels the need to instill in us the message that he understands science may stem from the fact that his first attempt at discussing autism and vaccines met with disaster. He published an article “deadly immunity” (because, you know, very pro-vaccine people use terms like “deadly immunity” to discuss vaccines, right?). This article was published both in Rolling Stone and Salon.com. In Salon’s Correcting our record, We’ve removed an explosive 2005 report by Robert F. Kennedy Jr. about autism and vaccines. Here’s why we read:

In 2005, Salon published online an exclusive story by Robert F. Kennedy Jr. that offered an explosive premise: that the mercury-based thimerosal compound present in vaccines until 2001 was dangerous, and that he was “convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real.”

The piece was co-published with Rolling Stone magazine — they fact-checked it and published it in print; we posted it online. In the days after running “Deadly Immunity,” we amended the story with five corrections (which can still be found logged here) that went far in undermining Kennedy’s exposé. At the time, we felt that correcting the piece — and keeping it on the site, in the spirit of transparency — was the best way to operate. But subsequent critics, including most recently, Seth Mnookin in his book “The Panic Virus,” further eroded any faith we had in the story’s value. We’ve grown to believe the best reader service is to delete the piece entirely.

“I regret we didn’t move on this more quickly, as evidence continued to emerge debunking the vaccines and autism link,” says former Salon editor in chief Joan Walsh, now editor at large. “But continued revelations of the flaws and even fraud tainting the science behind the connection make taking down the story the right thing to do.” The story’s original URL now links to our autism topics page, which we believe now offers a strong record of clear thinking and skeptical coverage we’re proud of — including the critical pursuit of others who continue to propagate the debunked, and dangerous, autism-vaccine link.

“…critical pursuit of others who continue to propagate the debunked, and dangerous, autism-vaccine link”. Not exactly a ringing endorsement of Mr. Kennedy’s approach nor the “science” he still promotes.

One take a moment here to discuss Mr. Kennedy’s strong record of advocating for real changes that would benefit autistics. Or we could if there were such a record. Again, we aren’t his focus. We are his tool.

So, given this long introduction, what about the claim that that the MMR vaccine contains mercury? It is in this video Mr. Kennedy produced recently. And while it may seem like a small thing, it is a clear example of misunderstanding or ignoring simple facts in order to support his argument that mercury in vaccines cause autism. Mr. Kennedy is jumping on the controversy that Brian Hooker and Andrew Wakefield tried to make last year about the MMR vaccine.

Now for those who have a basic understanding of the science, one will immediately wonder, “why is Kennedy latching on to this MMR story when there is no mercury in the MMR vaccine?” Not only does the MMR vaccine not contain mercury, it can’t contain mercury. The MMR vaccine is a live virus vaccine. Mercury is a preservative; it’s specific purpose is to kill bacteria (mostly) and viruses.

Let’s leave out the other huge warning flags here–such as the current MMR controversy Wakefield and Hooker tried to create is based on a huge amount of misrepresentations. Let’s ignore that and ask, surely Mr. Kennedy wouldn’t claim that the MMR vaccine contains mercury, right? Because that would mean either he doesn’t care about the facts or doesn’t understand the facts. It would suggest that sticking to very simple facts is taking back seat to political advocacy.

Why care, one might ask? Politicians have been ignoring facts for millennia. I care beause of the harm Mr. Kennedy brings to my community. I care because he is be scaring parents, especially African American parents, needlessly and convincing them to avoid a vaccine which prevents three very serious diseases. But more, he’s instilling in a new community the guilt and shame that comes with belief in the vaccines-cause-autism idea.

Given that long intro, here’s the video where Mr. Kennedy sends out his message to the African American community:

You can jump right to the point I’m discussing (6:45 into the video).

“…it proved that these vaccines, these mercury containing vaccines particularly, were causing autism”

When he’s talking about the William Thompson story, he’s talking about this study, Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta. He’s talking about the MMR vaccine.

Again, the MMR doesn’t contain mercury. Never has. In fact, it can’t. And there’s no good reason why after all these years why Mr. Kennedy would not know this. In his book “Thimerosal, let the science speak”, Mr. Kennedy on two occasions (Kennedy MMR-not thimerosal 1 and Kennedy MMR-not thimerosal 1) notes that the MMR vaccine does not contain mercury.

Again, this may seem like a small thing–he got this fact wrong. So what?

There was a time when I thought that the leaders of the movements that promote the idea that vaccines cause autism were just misguided. Probably good, decent people who somehow got themselves to believe wrong ideas. It’s not that hard to believe in something false, and just because you are wrong doesn’t mean you are lying.

Well, in my opinion, that doesn’t describe Mr. Kennedy. And as I’ve noted, the consequences for my community are huge. And I don’t appreciate Mr. Kennedy what appears to be Mr. Kennedy using us as his tool.


By Matt Carey

Press Release: New Research Finds No Evidence That Thimerosal-Containing Vaccines Affect Behavior or Neuroanatomy in Infant Primates

30 Sep

Below is a press release from the Johnson Center for Child Health and Development (formerly Thoughtful House). The press release discusses a recent study which investigated the safety of vaccine schedules (present and past) using monkeys as test subjects.

The study is a follow on study to a previous series of pilot studies involving some of the same authors. The pilot studies were considered by many to be an indication of evidence that vaccines cause autism and other neurological conditions. This larger study shows no evidence of adverse effects from vaccines.

Here is the press release:

New Research Finds No Evidence That Thimerosal-Containing Vaccines Affect Behavior or Neuroanatomy in Infant Primates

(Austin, Texas) – September 28, 2015 – New research finds no evidence that thimerosal- containing vaccines cause negative behaviors or result in neuropathology in infant primates, according to a study that will be published today in the Proceedings of the National Academy of Sciences. In this study, conducted by Dr. Dwight German of the University of Texas Southwestern School of Medicine, and colleagues, infant rhesus macaques received several pediatric vaccines containing thimerosal (a mercury-based preservative) in a schedule similar to that given to infants in the 1990s. Other animals received just the measles-mumps- rubella (MMR) vaccine, which does not contain thimerosal, or an expanded vaccine schedule similar to that recommended for US infants today. Control animals received a saline injection.

Regardless of vaccination status, all animals developed normal social behaviors. Cellular analysis of three brain regions, the cerebellum, amygdala and hippocampus (all known to be altered in autism), was similar in vaccinated and unvaccinated animals.

“This comprehensive analysis of social behavior and neuropathology in 12-18 month old rhesus macaques indicated that vaccinated primates were not negatively affected by thimerosal; the same was true for animals receiving an expanded 2008 vaccine schedule, which is similar to that recommended for US infants today” explained Dr. Laura Hewitson of The Johnson Center for Child Health and Development, one of the principle investigators working on the study. Hewitson was part of a team of researchers from The Johnson Center; the University of Texas Southwestern; the Center on Human Development and Disability Infant Primate Research Laboratory; the Washington National Primate Research Center (WaNPRC) at the University of Washington, Seattle WA; and Texas A&M Health Science Center & Central Texas Veterans Health Care System.

According to Hewitson, the study was designed to compare the safety of different vaccination schedules, including the schedule from the 1990s, when thimerosal was used as a preservative in multi-dose vaccine preparations. The data from this study indicate that administration of TCVs and/or the MMR vaccine to rhesus macaques did not result in neuropathological abnormalities,or aberrant behaviors, like those often observed in autism.


Citation
Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology. Bharathi S. Gadad, Wenhao Li, Umar Yazdani, Stephen Grady, Trevor Johnson, Jacob Hammond, Howard Gunn, Britni Curtis, Chris English, Vernon Yutuc, Clayton Ferrier, Gene P. Sackett, C. Nathan Marti, Keith Young, Laura Hewitson and Dwight C. German. PNAS

This article can be downloaded for free here.

This study was supported by The Ted Lindsay Foundation, SafeMinds, National Autism Association, and the Johnson and Vernick families. This work was also supported by WaNPRC Core Grant RR00166 and CHDD Core Grant HD02274.

About The Johnson Center
The mission of The Johnson Center for Child Health and Development is to advance the understanding of childhood development through clinical care, research, and education.

Previous Press Releases
For Immediate Release
Contact: media@johnson-center.org
512-732-8400


By Matt Carey

Another large study shows no link between autism and the MMR vaccine (or, a comment on “Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism”

22 Apr

Autism is not associated with the MMR vaccine. The MMR vaccine does not increase autism risk. To put it in plain language: the MMR vaccine does not cause autism.

Just in case the message gets lost in this discussion, I figured I’d put it plainly at the start.

A study out today compares autism rates and the use of the MMR vaccine. In specific, the researchers looked at children with an older sibling. In this way they could look at kids in a high risk group, those who had an older sibling who is autistic. The authors also looked at kids who had older siblings who are not autistic. In the end the authors found “receipt of the MMR vaccine was not associated with increased risk of ASD, regardless of whether older siblings had ASD”.

To put it simply, kids who got the MMR vaccine were not more likely to be autistic. It doesn’t matter if their older siblings were autistic or not. So, “high risk” or not, the MMR vaccine doesn’t increase autism risk.

Another way to say it, parents who skipped the MMR vaccine did nothing to prevent autism in their younger kids. Nothing. They did leave their younger kids vulnerable to measles infection.

Here’s the abstract.

Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism.

IMPORTANCE:
Despite research showing no link between the measles-mumps-rubella (MMR) vaccine and autism spectrum disorders (ASD), beliefs that the vaccine causes autism persist, leading to lower vaccination levels. Parents who already have a child with ASD may be especially wary of vaccinations.

OBJECTIVE:
To report ASD occurrence by MMR vaccine status in a large sample of US children who have older siblings with and without ASD.

DESIGN, SETTING, AND PARTICIPANTS:
A retrospective cohort study using an administrative claims database associated with a large commercial health plan. Participants included children continuously enrolled in the health plan from birth to at least 5 years of age during 2001-2012 who also had an older sibling continuously enrolled for at least 6 months between 1997 and 2012.

EXPOSURES:
MMR vaccine receipt (0, 1, 2 doses) between birth and 5 years of age.

MAIN OUTCOMES AND MEASURES:
ASD status defined as 2 claims with a diagnosis code in any position for autistic disorder or other specified pervasive developmental disorder (PDD) including Asperger syndrome, or unspecified PDD (International Classification of Diseases, Ninth Revision, Clinical Modification 299.0x, 299.8x, 299.9x).

RESULTS:
Of 95 727 children with older siblings, 994 (1.04%) were diagnosed with ASD and 1929 (2.01%) had an older sibling with ASD. Of those with older siblings with ASD, 134 (6.9%) had ASD, vs 860 (0.9%) children with unaffected siblings (P < .001). MMR vaccination rates (≥1 dose) were 84% (n = 78 564) at age 2 years and 92% (n = 86 063) at age 5 years for children with unaffected older siblings, vs 73% (n = 1409) at age 2 years and 86% (n = 1660) at age 5 years for children with affected siblings. MMR vaccine receipt was not associated with an increased risk of ASD at any age. For children with older siblings with ASD, at age 2, the adjusted relative risk (RR) of ASD for 1 dose of MMR vaccine vs no vaccine was 0.76 (95% CI, 0.49-1.18; P = .22), and at age 5, the RR of ASD for 2 doses compared with no vaccine was 0.56 (95% CI, 0.31-1.01; P = .052). For children whose older siblings did not have ASD, at age 2, the adjusted RR of ASD for 1 dose was 0.91 (95% CI, 0.67-1.20; P = .50) and at age 5, the RR of ASD for 2 doses was 1.12 (95% CI, 0.78-1.59; P = .55).

CONCLUSIONS AND RELEVANCE:
In this large sample of privately insured children with older siblings, receipt of the MMR vaccine was not associated with increased risk of ASD, regardless of whether older siblings had ASD. These findings indicate no harmful association between MMR vaccine receipt and ASD even among children already at higher risk for ASD.


By Matt Carey

D.A.I.R. Foundation 2013 tax form, about $100k in revenue, $20k in program expenses

5 Mar

A few years back Andrew Wakefield decided to sue the BMJ and Brian Deer.  This followed a series of articles and public statements that Mr. Wakefield’s work was an “elaborate fraud” and Mr. Wakefield himself was a fraud.   Lawsuits involve attorneys and attorneys cost money, so a few efforts arose to help Mr. Wakefield pay for these costs.  I believe the first was the “Dr. Wakefield Justice Fund”.  This didn’t come across as a major effort, the twitter account made three tweets, the website appears to be down (here’s an archived version), and it doesn’t appear to have made charity status.  Another effort that came out was the Academic Integrity fund.  Again, the website seems to be down, but again there’s the archive.  In many ways it’s too bad that site didn’t continue as it because a place for Mr. Wakefield to place essays.  And his writing, while tedious, produced interesting insights into his thoughts. For example:

Obama must meet the autism tragedy head on and deal with the proximate cause of the epidemic – unsafe and untested vaccination practices.

This from a man whose supporters claim never says that vaccines cause autism.

And we can also read the approach that would later prove fatal for Alex Spourdalakis: autism must be considered a medical, especially gastrointestinal, condition and that psychiatric medications to be avoided and that are behind mass murderers.

Tragically, predictably, there will be more events like at Sandy Hook Elementary. The vast number of individuals with developmental disorders presages such events. This is not because of their diagnosis, per se, but rather I would suggest, because they may be at increased risk for adverse reactions (due to pre-existing conditions) and are being inappropriately medicated with drugs for which violence is a recognized adverse reaction. These drugs are being prescribed by a “mainstream”

Not all the fundraising efforts failed.  We also saw the rise of a group calling itself the “Defending Academic Integrity and Research” or D.A.I.R. Foundation.  D.A.I.R. states under “what we do”:

Justice is accessible only to those who can afford it. D.A.I.R. Foundation provides legal aid, coordinated public relations support, and educational materials that support the work of our sponsored applicants.

Reading their site, one applies for support and D.A.I.R. provides financial support, PR and other help.

D.A.I.R. Foundation has an open request for proposals from researchers, physicians, scientists, and academic policy drivers who have come under attack and are interested in applying for legal aid. Please Contact Us and note in the subject line “Applicant Inquiry”. Applicants follow an approval review process. Applicants who are accepted will be expected to agree to terms and conditions of the legal aid process to include partnership in strategy that assures success and can be leveraged in future cases, proceeds to D.A.I.R. Foundation following legal compensation, and development of educational and public relations materials. We also assist in reputation management

I emailed them asking for a copy of their “terms and conditions” but they did not reply.  I find it interesting that people are expected to work with D.A.I.R in developing educational an public relations materials, and apparently provide a share of the proceeds of any legal settlements they achieve.

They hold fundraisers, and it appears that Andrew Wakefield is a featured speaker at these events.  The event linked on their website was not inexpensive, but also appears to have left a large number of seats unsold. (click to enlarge)

DAIR fundraiser

Of course this leaves us wondering, how much money did D.A.I.R. bring in and how did they use it?  Well, here’s the D.A.I.R. Foundation 2013 form 990.

From this we learn that they brought in $104,488.  Of that $20,859 was spent on a grant (I assume to Andrew Wakefield).  But that is less than 1/3 of their expenses. (click to enlarge)

DAIR 1

They spent $14,889 on salary for Dawn Loughborough (the executive director). They spent $15,256 on catering and $7,383 on travel, plus other expenses. (click to enlarge)

DAIR 2

Or, to put it simply: they took in about $100k.  Of this about $20k went to actual program expenses, over $45k went to salary and other expenses and about $37k was left in the bank.

If you dontated, about $0.20 of each dollar went to program expenses (presumably Mr. Wakefield’s expenses) about $0.45 went to overhead and about $0.35 may be used for program expenses at a later time.

Should this grant have gone to Mr. Wakefield, I don’t see that covering a large fraction of his expenses for his failed lawsuit.  Perhaps I’m wrong, but the effort involved multiple lawyers and many, many pages of documents.

By Matt Carey