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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 Dr-Wakefield-Solina-and-Lee[1]

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

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