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Cochrane review: no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD

10 Sep

Chelation was never used by the majority of parents on their autistic kids. And that is a good thing. Chelation use is way down in the autism communities, but it hasn’t gone away. Many of those who use chelation are also vaccine antagonistic, and many of those rely upon the Chochrane reviews to support their vaccine-antagonistic arguments (generally by cherry picking and misrepresenting the Chochrane reviews). So, I was intrigued when I saw this abstract come up recently: Chelation for autism spectrum disorder (ASD).

A Chochrane team looked at the evidence for chelation and found that there is none.

A while back there was a plan for a chelation trial at the National Institutes of Health. It was cancelled when animal studies found a drop in cognitive scores when chelation was used without heavy metal intoxication. Which is to say, if you chelate someone needlessly, you could be shaving off IQ points. And since there is no evidence that autism is a form of heavy metal intoxication, chelation may actually have been harming already disabled kids.

I bring this up because the Chochrane review mentions a possible clinical trial in their last abstract sentence: “Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.”

Yeah, I know that teams of people with MBA’s and other non-related degrees will tell you that there is evidence. As will doctors who sell chelation. Or recommend it (Hello, Dr. Bob Sears, I’m talking to you and your community of non-autism docs). They are wrong. And potentially harming autistic children.

Here is the abstract

Abstract
BACKGROUND:
It has been suggested that the severity of autism spectrum disorder (ASD) symptoms is positively correlated with the level of circulating or stored toxic metals, and that excretion of these heavy metals, brought about by the use of pharmaceutical chelating agents, results in improved symptoms.
OBJECTIVES:
To assess the potential benefits and adverse effects of pharmaceutical chelating agents (referred to as chelation therapy throughout this review) for autism spectrum disorder (ASD) symptoms.
SEARCH METHODS:
We searched the following databases on 6 November 2014: CENTRAL, Ovid MEDLINE, Ovid MEDLINE In-Process, Embase,PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and 15 other databases, including three trials registers. In addition we checked references lists and contacted experts.
SELECTION CRITERIA:
All randomised controlled trials of pharmaceutical chelating agents compared with placebo in individuals with ASD.
DATA COLLECTION AND ANALYSIS:
Two review authors independently selected studies, assessed them for risk of bias and extracted relevant data. We did not conduct a meta-analysis, as only one study was included.
MAIN RESULTS:
We excluded nine studies because they were non-randomised trials or were withdrawn before enrolment.We included one study, which was conducted in two phases. During the first phase of the study, 77 children with ASD were randomly assigned to receive seven days of glutathione lotion or placebo lotion, followed by three days of oral dimercaptosuccinic acid (DMSA). Forty-nine children who were found to be high excreters of heavy metals during phase one continued on to phase two to receive three days of oral DMSA or placebo followed by 11 days off, with the cycle repeated up to six times. The second phase thus assessed the effectiveness of multiple doses of oral DMSA compared with placebo in children who were high excreters of heavy metals and who received a three-day course of oral DMSA. Overall, no evidence suggests that multiple rounds of oral DMSA had an effect on ASD symptoms.
AUTHORS’ CONCLUSIONS:
This review included data from only one study, which had methodological limitations. As such, no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD. Given prior reports of serious adverse events, such as hypocalcaemia, renal impairment and reported death, the risks of using chelation for ASD currently outweigh proven benefits. Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.


By Matt Carey

SafeMinds: why won’t you tell your membership about the vaccine safety study you funded? Perhaps because it says vaccines are safe?

28 Aug

Earlier this year a paper was published on vaccine safety: Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior. This was a followup study to earlier pilot studies that got a lot of attention in the “vaccines-cause-autism” groups (Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: influence of gestational age and birth weight and Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: a pilot study.)

It is worth noting that the pilot studies didn’t link vaccines to autism. They did make claims that some early reflexes were delayed in the monkeys given thimerosal containing vaccines. If you see someone talking about “root” or “snout” or “suck” reflexes in a vaccine discussion, they are referring to the studies above. These were pilot studies–small preliminary studies to see if it is worth launching a larger study. As such the results should have been taken with caution. But caution is not what groups like SafeMinds (or any of the groups that promote the failed vaccine-autism link) are known for. Inflating any scrap of evidence that can support their political point of view, that’s what they are known for.

SafeMinds made a big deal out of the early studies. Mark Blaxill (then of SafeMinds) called the study a “blockbuster” in a four thousand word analysis. That’s a lot of space to devote considering the full study was eight thousand words. And, as noted already, preliminary. But politics is politics.

Now, an intellectually honest person, or group, would watch for the followup study and report on it no matter the result. Because, let’s face it, if you are going to spend 4000 words overstating the importance of a study, scaring people and instilling them with guilt and pain over their child’s disability, you have a responsibility to do a follow up.

If you are intellectually honest.

So, as noted above, the follow up study was published. It was published in April. Four months ago. And I don’t see anything from Mr. Blaxill on the Age of Autism blog (where he posted his “blockbuster” article) or at the SafeMinds website on the followup study. SafeMinds has their own blog, and if you search it for, say “snout”, you get this article (Ground-Breaking Monkey Study: Mercury-Containing Hepatitis B Vaccine Causes Brain Damage) on the pilot study, calling it “groundbreaking” and claiming that it demonstrates that the thimerosal containing HepB vaccine causes brain damage.

Very strong words. Words which, if overblown, are very damaging. Imagine going through life as a parent thinking that you agreed to a vaccine and that caused brain damage to your child. Now imagine that the evidence you used to draw that conclusion was (a) not strong to begin with and (b) now refuted.

Wouldn’t you want to know the truth? Wouldn’t you expect the people and the organizations that convinced you of this falshood to seek you out and correct their mistake?

And this is why people don’t hold Mr. Blaxill or SafeMinds in high regard. They are quick to scare but don’t have the courage to admit they were wrong. Courage isn’t standing up and saying unpopular truths. Courage is standing up and admitting that your “unpopular truth” was, in fact, not the truth at all.

Now, why pick on SafeMinds in specific here? A lot of people and groups jumped on the pilot study and spread a lot of fear. Check out the footnotes of the study.

This work was supported by the Ted Lindsay Foundation, SafeMinds, National Autism Association, the Vernick family, and the Johnson family

SafeMinds helped fund the new study. The one they are ignoring. They were likely aware of the results before they were published. But no word.

I expect more from decent advocacy organizations. But I am not surprised with SafeMinds, nor Mark Blaxill.

Yes, the National Autism Association did too and they need to step up as well (a point I hope to make in a later article).

How about the Johnson Family? Well, the Johnson Center stepped up and put out a press release New Research Finds No Evidence That Thimerosal-Containing Vaccines Affect Neurodevelopment and Behavior in Infant Primates. (all SafeMinds, the Age of Autism and the National Autism Association needs to do as a start is publish the press release).

Here’s the last sentence of the press release, quoting the lead researcher: “Despite these limitations, the data in this primate study overwhelmingly provides support for the safety of pediatric vaccines”

It would take a lot of courage for SafeMinds and Mark Blaxill to publicize such a statement. More than they have.


By Matt Carey

Jim Carrey, you are part of the problem for us in the Autism Community

15 Jul

Years back Jim Carrey was and autism were mentioned together regularly in the news.  This was at the height of the vaccine misinformation campaign of his then partner, Jenny McCarthy.  Mr. Carrey went so far as to be a speaker at the “Green Our Vaccines” rally in Washington.  That was 2008. Since then the Green Our Vaccines as a movement has died, Jenny McCarthy has tried to distance herself from her very vocal stance on vaccines, and given that Mr. Carrey and Ms. McCarthy split, it seemed like we had seen the last of Mr. Carrey.

Until recently.

You see Mr. Carrey took offense to new legislation in California.  A bill that will roll back vaccine exemptions to where personal belief exemptions will no longer be accepted in the schools here.  In other words, for the most part one will now need an actual medical reason to avoid vaccination in order to register for public school.

Mr. Carrey took to twitter with his complaints about the new law.  All well and good, free speech and all.  But Mr. Carrey went too far. He decided to take pictures of kids in distress and the implication that this is what happens when you vaccinate your kids. One tweet read ““A trillion dollars buys a lot of expert opinions. Will it buy you? TOXIN FREE VACCINES, A REASONABLE REQUEST!”” and included a picture of an autistic kid (the other pictures he used appear to have been stock images). The story is discussed by Emily Willingham as Jim Carrey Unwittingly Brings Attention To Something Actually Linked To Autism

And Time Magazine in Jim Carrey Apologizes for Using Photo of Autistic Boy in Anti-Vaccination Tweet.

Because, to give him credit, Mr. Carrey did apologize to that family. (Ironically, it turns out that the kid was unvaccinated when he was first diagnosed autistic).

I harken back to Mr. Carrey’s time with the autism community (remember when Generation Rescue was tagged as “Jenny McCarthy and Jim Carrey’s Autism Organization”?). At one speech, probably the Green Our Vaccines Rally, Mr. Carrey made the pseduo-profound statement, “We are not the problem. The problem is the problem.”

So while I do appreciate Mr. Carrey stepping up and apologizing to one family, I do want to point out: Mr. Carrey, you were one of the problems for the autism community. And you apparently still are.

Ms. McCarthy introduced you to a closed group of people, a small sampling of the autism community. You likely came away thinking that they *are* the autism community, because that’s how they think of themselves.

They aren’t.

Most of us autism parents don’t subscribe to the vaccine causation idea. I can provide the links to multiple studies if you like, but it’s just the way things are.

And autism parents are not the autism community. One thing that Generation Rescue and like organizations have done is act like autistics are some sort of second class citizens in the community. Who do you think the community primarily is, autistics or parents?

Here’s the thing: the vaccine-causation idea is probably the most damaging notion to have hit the autism community. Did you hear about the “refrigerator mother” theory during your time at Generation Rescue? It’s second to the vaccine causation theory. Telling generations of disabled kids that they are less than they are, that they should be someone else, is damaging. Mr. Carrey, did you attend any of those parent conventions, like AutismOne? Perhaps you look at alternative medicine favorably. Well, the vaccine causation idea is used to sell “therapies” that aren’t close to being “alternative”. They are just wrong. And, frankly, abusive. Chemical castration of disabled children? This was promoted multiple times at conventions where your former partner was a keynote speaker. Fake diagnoses of mercury poisoning, followed by chelation? Same. And even a major promoter of chelation has a new study showing it doesn’t work. Did anyone tell you why the NIH autism/chelation trial was stopped? Because if you chelate test animals who do not have mercury intoxication, they go down cognitively. If the same happens in humans, tens of thousands of autistic children lost some IQ due to chelation. Think that one over, since GR started out as primarily an org promoting chelation. Daily bleach drinks and bleach enemas? That one is probably new since you dropped out. But, yep, that gets sold as a cure for “vaccine injury”. Shall I go on? Because I can. The autism=vaccine injury idea sells junk medicine which is subjected upon disabled children.

And you added your voice to the vaccine-causation idea.

You’ve apologized to one family. That took guts. Now step up and start making amends to the rest of us. Parents and, especially, autistics.


By Matt Carey

Comment on: Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior.

21 Feb

There is a common myth one hears from one group of autism parents: there is no research on autism and vaccines being performed. Usually this is combined with the insinuation that the government is scared of vaccine/autism research. The claims are often made by people who should (and likely do) know better.

One of the few places one can find a discussion of the ongoing vaccine/autism work is here at Left Brain/Right Brain. In a post last year I address the question of Why won’t the government fund vaccine/autism research?, which was really a post about how there is work being funded. In case the title was unclear, I also wrote More of that vaccine/autism research that doesn’t exist. Other articles include What projects are being funded in autism research? Part 1: vaccines and GI issues.

In one of those articles I wrote:

There’s a study by Gene Sackett’s group, A PRIMATE MODEL OF GUT, IMMUNE, AND CNS RESPONSE TO CHILDHOOD VACCINES. This appears to be a follow on project to the Laura Hewitson studies that were discussed a great deal online a few years ago.

And, guess what? A study by Gene Sackett, together with Laura Hewitson and others, has just been published: Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior. It may not be the study referenced above as that study was government funded, but this new study addresses some of the concerns raised by previous studies published by Laura Hewitson’s team. If you wonder what I mean by “addressed”, here’s the last phrase of the abstract: the study “…provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.”

No evidence of harm.

Gene Sackett was a collaborator on one of those previous studies by Laura Hewitson: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: influence of gestational age and birth weight. This study was discussed a great deal by those promoting the vaccine/autism link (say here, here, here and elsewhere. It was called a “blockbuster” study by Mark Blaxill (then of SafeMinds, now of the Canary Party, both groups who promote the failed idea that the rise in autism diagnoses was caused by thimerosal in vaccines) on the Age of Autism blog. Dan Olmsted (of the same blog) called the results “explosive”. They both downplayed the preliminary nature of the study and the small sample size and way overplayed the importance of the results.

And as this new study clarifies, both were wrong. Both spread guilt and fear: one can still find parents talking online about how their child was delayed in one of the reflexes discussed in the study and, thus, was harmed by thimerosal in vaccines. Just an example of the harm the people pushing the idea that vaccines and autism are linked have caused.

As noted above, this new study clears up the concerns raised by the earlier studies. If history is any guide, Mr. Olmsted and Mr. Blaxill will not demonstrate the courage needed to admit their mistakes nor try to correct the damage they have caused. I would love to be wrong and have to write an apology to them.

Here is the abstract to Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior.

Abstract
BACKGROUND:
In the 1990s, the mercury-based preservative, thimerosal, was used in most pediatric vaccines. While there are currently only two thimerosal-containing vaccines (TCVs) recommended for pediatric use, parental perceptions that vaccines pose safety concerns are affecting vaccination rates, particularly in light of the much expanded and more complex schedule in place today.
OBJECTIVES:
The objective of this study was to examine the safety of pediatric vaccine schedules in a non-human primate model.
METHODS:
We administered vaccines to 6 groups of infant male rhesus macaques (n=12-16/group) using a standardized thimerosal dose where appropriate. Study groups included the recommended 1990s pediatric vaccine schedule, an accelerated 1990s primate schedule with or without the measles-mumps-rubella (MMR) vaccine, the MMR vaccine only, and the expanded 2008 schedule. We administered saline injections to age-matched control animals (n=16). Infant development was assessed from birth-12 months of age by examining the acquisition of neonatal reflexes, the development of object concept permanence (OCP), computerized tests of discrimination learning, and infant social behavior. Data were analyzed using ANOVAs, multi-level modeling, and survival analyses, where appropriate.
RESULTS:
There were no group differences in the acquisition of OCP. During discrimination learning animals receiving TCVs had improved performance on reversal testing, although some of these same animals performed poorer in subsequent learning set testing. Analysis of social and non-social behaviors identified few instances of negative behaviors across the entire infancy period. While some group differences in specific behaviors were reported at 2 months of age, by 12 months all infants, irrespective of vaccination status, had developed the typical repertoire of macaque behaviors.
CONCLUSIONS:
This comprehensive five-year, case-control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.

Let’s repeat that conclusion for emphasis: This comprehensive five-year, case-control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.

The full paper is available online. In it you can read this:

This data is in contrast to our previous pilot study in which a delay in the acquisition of the root, suck, and snout survival reflexes were reported for primate infants following exposure to the birth dose of the thimerosal containing Hep B vaccine (Hewitson et al. 2010a). This discrepancy is most likely due to the larger number of animals in the present study providing more accurate estimates. Furthermore, in the present study reflexes were examined from birth to 21 days of age, during which some animals received multiple TCVs (not just a single Hep B vaccine as was used in the previous 23 study), and yet no detrimental effects on the acquisition of survival reflexes were reported for these animals.

Hewitson 2010a is Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: Influence of gestational age and birth weight. This is the “blockbuster” study according to Mark Blaxill. Ironically, Mr. Blaxill’s article links to the first publication of the “blockbuster”, the version that was retracted.

The first thing that people who promote the vaccine/autism link would do with a study like this, one that doesn’t find a link between vaccines and harm, is claim that it isn’t “independent” and the authors and/or funding agencies are too biased. So, let’s look at the authors

Britni Curtis,1 Noelle Liberato,1 Megan Rulien,1 Kelly Morrisroe,1 Caroline Kenney,1 Vernon Yutuc,1 Clayton Ferrier,1 C. Nathan Marti,2 Dorothy Mandell,3 Thomas M. Burbacher,1,4 Gene P. Sackett,1,5 and Laura Hewitson1,6,7

1Infant Primate Research Laboratory (IPRL), Washington National Primate Research Center, and Center on Human Development and Disability (CHDD), Seattle, Washington, USA; 2Abacist Analytics, LLC, Austin, Texas, USA; 3Independent Consultant, Austin, Texas, USA; 4Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; 5Department of Psychology, University of Washington, Seattle, Washington, USA; 6The Johnson Center for Child Health and Development, Austin, Texas, USA; 7Department of Psychiatry, University of Texas Southwestern, Dallas, Texas, USA

Laura Hewitson was the lead researcher in the previous macaque studies, the ones often quoted as providing evidence of a link between thimerosal and autism. Her organization (The Johnson Center for Child Health and Development) was formerly referred to as Thoughtful House and was directed in that time by Andrew Wakefield. Thomas Burbacher and Gene Sackett have also been involved with previous animal studies on thimerosal, including this one often cited again as evidence of a link between vaccines and autism.

The funding?

This work was supported by The Ted Lindsay Foundation, SafeMinds, National Autism Association, the Vernick family, and the Johnson family. This work was also supported by WaNPRC Core Grant RR0166 and CHDD Core Grant HD02274.

Both SafeMinds and the National Autism Association are strong proponents of the idea that vaccines cause autism.

Under competing financial interests we read:

Competing financial interests: Drs. Marti and Mandell provided consulting services as independent contractors in regards to the data analyses. Neither person has provided services to pharmaceutical companies that manufacture vaccines or their representatives, nor have they been an expert witness in thimerosal, or similar suits. The other authors declare they have no actual or potential competing financial interests.

I will leave you with the final paragraph of the new study

In summary, we did not find evidence of an adverse impact of vaccination status on early neurodevelopmental measures, including the acquisition of neonatal reflexes and the development of object permanence. This was true for animals receiving TCVs, as well as animals in the 2008 group, which received the expanded pediatric vaccine schedule that remains very similar to the currently recommended schedule. Although some animals receiving TCVs performed better in the reversal phase of discrimination learning compared to controls, this association was not consistent across all study groups with thimerosal exposure. Furthermore, learning set performance appeared to be poorest for animals in the TCV group but this observation was not mirrored in the 1990s Primate group. Finally, all infants, irrespective of vaccine status, developed the typical social behaviors for this age of animal, with very few instances of negative behaviors reported. While the data as a whole does not support a consistent adverse effect of TCVs on primate development, factors that may modulate the toxicokinetics and toxicodynamics of thimerosal, such as genetics, gender, birth weight, gestational age, maternal health, and chemical co-exposures, should be thoroughly investigated.


By Matt Carey

Andrew Wakefield’s CDC Whistleblower documentary trailer. Words can not do this justice.

20 Nov

Andrew Wakefield, the British former academic surgeon who fueled the MMR scare, has turned to film making as his career.  Someone chose Mr. Wakefield to manage the publicity for what they termed the “CDC Whistleblower” incident. to recap that: a William Thompson from the CDC had the extreme bad judgment to approach Brian Hooker with concerns about an old MMR/autism study.  Mr. Hooker is well known for his antagonistic stance on vaccines and his bad science attempting to link vaccines and autism.  Mr. Hooker published a (now retracted) study based on the information given to him by Mr. Thompson at CDC.  To publicize this “CDC Whistleblower” incident, Mr. Wakefield came out with probably the most over-the-top bad video I’ve ever seen.   It’s basically the Plan 9 From Outer Space of mini documentaries, complete with Mr. Wakefield’s voice over claiming that the CDC are worse that Hitler, Pol Pot and Stalin.  Those dictators, you see, were at least sincere in Mr. Wakefield’s view.

Well it seems Mr. Wakefield wants to expand the “CDC Whistleblower” story to a full documentary.  He has an indigogo campaign to raise funds. As of now, it has collected $2,213 of his $230,000 goal.

And now he has a trailer.  It is seriously worth a look.  And before you read my own commentary on this one.  Here, go ahead:

Thankfully it is not as long at the Hitler/Pol Pot/Stalin video so I could manage to watch it again.  Because on one view I just had to say–really? Is this for real?

We start out with a shadowy figure. Presumably an actor playing the role of the whistleblower (although, physically he looks more like Poul Thorsen than Mr. Thompson).

Feast-shadow figure

Interspersed with video of autistic kids in severe distress, we get images of police in riot gear.  Because, that’s what one does in a documentary, splice in footage that has nothing to do with the story, right?feast-riot gear

And, lest we forget, a helicopter.  Black.  Has to be black.  OK, it looks like only the bottom is black, but as that quick clip went by all I could think was “really?  A black helicopter? ”

feast black helicopter

And in case we had any remaining thoughts that this was a documentary, enter the image of a house as seen through a sniper scope.  As the sniper scope zooms in we see that the target is an African American in a wheel chair.

feast sniper

Perhaps this is some sort of allusion to Mr. Wakefield’s first video, the Hitler/Pol Pot/Stalin video where he claimed that the CDC was engaging in a new Tuskegee experiment.   If so, why is the image of an African American female? I ask because the alleged controversy Mr. Wakefield is trying to highlight was about African American males.

The video ends with footage of parents telling us that vaccines cause autism and an actor (presumably representing the “whistleblower”) walking up some stairs.  Finally, Congressman Darrell Issa is shown banging a gavel at a congressional hearing.  From the start of these events, Mr. Wakefield and Mr. Hooker and their team have been calling for a congressional hearing.  I do hope they sent this video (and the Hitler/Pol Pot/Stalin video) to Mr. Issa’s office.  I have a feeling that since the time that Mr. Issa accepted $40,000 in donations from people seeking a congressional hearing, he’s learned a great deal and this video will further his education.

The sad part of this is the exploitative use of autistic children seen under severe distress.  This exploitation does nothing to serve the very real needs of our community.  Also seen towards the end are images of Avonte Oquendo, who went missing from his school and was found dead months later.  Again, exploitation which does nothing to serve our communities.  Mr. Wakefield is grabbing whatever film clips he can whether they are related or not to his purported story.  This is the same trick he used with a previous trailer he produced, where he spliced video from the Judge Rotenberg Center into a completely different story.

If Mr. Wakefield weren’t doing so much damage to my community, his videos would be laughably bad.  I’m not laughing.

By Matt Carey

Andrew Wakefield and Brian Hooker complain. Not honestly, but they complain

23 Oct

Andrew Wakefield and Brian Hooker have lately been trying to manage a “cdc whistleblower” story. The idea has been covered a lot recently, here and elsewhere. So, rather than go into more introduction, let’s take a look at the complaint they recently filed with the CDC office of research integrity. It’s long, so I’ll bring up a few glaring problems with the complaint letter. These problems have for the most part already been discussed here at Left Brain/Right Brain.

The basis of their arguments has been that allegedly the CDC found a statistically significant result suggesting that the MMR was associated with a higher odds ratio for autism in African American boys. They argue that the CDC then changed their protocol (analysis plan) to avoid reporting on this result. Mr. Wakefield and Mr. Hooker have since added a similar argument for “isolated autism”–autism without comorbid conditions like intellectual disability. They claim the CDC hid those results as well.

So, what does the complaint say in specific? It’s long, but here’s an interesting and key part and a good place to start. Under the section titled “The Georgia Birth Certificate Cohort (GBCC): what was its stated purpose?“, Hooker and Wakefield quote the

[Exhibit 2, page 7, emphasis added] The Analysis Plan, “Statistical Analyses” states that “race” data were available for the entire sample:

The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race.

[Exhibit 2, page 8, emphasis added]. Thus, “race” data came explicitly from the “school record” and not from the Georgia birth certificate/Georgia birth
records and was available for the “entire sample”.

The funny thing is that quote, “The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race” doesn’t match what’s in the screenshot of the analysis plan that Wakefield included in his recent YouTube video (click to enlarge).

Draft Plan 2

The plan actually states:

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

emphasis added.

See how “available to be assessed” in the actual plan has been changed into “that will be assessed” by Mr. Wakefield? Mr. Wakefield would like us to believe that the analysis plan called for a study to be reported broken down by race using all the kids in the study. He’s been arguing that since his first ugly “It’s like the Tuskegee experiment!” video. The thing is that the plan didn’t call for that. As I recently discussed, the sentence Mr. Wakefield misquotes was a statement of the limitations of the dataset they had (MADDSP) and explains why the CDC needed to get the birth certificate data to do a more thorough analysis.

As I also noted, the full paragraph references table included in the analysis plan made it clear that race was to be analyzed for the birth certificate sample, not the total sample as Mr. Wakefield is leading us to believe.  The title of the table shows us that they were planning to report detailed data on the birth certificate group, not the entire sample.

What I find interesting is that Wakefield and Hooker are not just misinterpreting the statement as I originally thought. In the complaint they clearly changed what the statement said. Besides being wrong all on it’s own, this change tells me they know that phrase they latched on to ( “The only variable that will be assessed as a potential confounder using the entire sample will be the child’s race”) doesn’t come close to fitting in with his story. I don’t see this as an honest mistake.

The complaint also includes the “isolated autism” argument Mr. Wakefield recently put into another YouTube video. In this, Mr. Wakefield claims that all sorts of methods were used to hide an association observed for MMR and autism without other conditions like intellectual disability, cerebral palsy, etc.. In his complaint and video, Mr. Wakefield claims one of the methods used to hide this association was by limiting “other conditions” to only “MR” (mental retardation/intellectual disability). In the video Mr Wakefield gives us a fragment of an audio attributed to Mr. Thompson of the CDC saying, “the effect is where you would think it would happen. It is with the kids without other conditions, without the comorbid conditions.”

Mr. Wakefield even went on to say

But that didn’t seem to happen. They deviated further from the analysis plan by limiting the isolated group to only those with no mental retardation. Even changing the age categories and composition of the isolated subgroup may not have achieved the desired effect. Since, in the end, they simply omitted the relevant findings from the paper altogether

Emphasis added.

As I said before, I found this odd in that the CDC did report an apparent association in the raw data. The total sample/unadjusted data. To repeat a quote by Mr. Thompson, “It’s all there!”

Destefano_table_4 highlighted

It’s numerically almost the exact same result as Mr. Wakefield says was concealed. So, if it’s the same, how is it concealed? How is it omitted? Answer: it isn’t.

Remember that quote attributed to William Thompson from the video? Here’s a more full quote that’s from the complaint:

You see that the strongest association is with those [autistic cases] without mental retardation. The non-isolated [sic], the non-MR [mental retardation]…the effect is where you would think it would happen. It is with the kids without other conditions, without the comorbid conditions.

Mr. Wakefield wanted us to believe that by switching to autism without MR instead of autism without MR and/or other disabilities, the CDC were covering up the result.  Not only did the CDC report on the result, this isn’t what Mr. Thompson was saying.  Thompson is not saying, “hey look, we only used MR as a way to conceal the result.” He’s saying, in effect: when we looked at autism without MR, we saw this effect. It looks to me like Thompson is drawing Mr. Hooker’s attention to a result in the paper. Not describing an omitted result hidden from the public.

So, what is it? Did the CDC “simply omit the relevant findings altogether” as Mr. Wakefield stated in his video? No, they didn’t. Don’t take my word for it, take the word of Andrew Wakefield and Brian Hooker. In their complaint they state

2.7. The Group further deviated from the Analysis Plan by limiting the “isolated” group to only those without mental retardation, as published in The Paper.

Emphasis added.

So, we in the autism communities get one story in the video (the result was omitted), but in a legal document he puts the truth (the result was published in the paper).

And, how did the CDC accomplish all this alleged cover up in the story told by Mr. Wakefield and Mr. Hooker? Well, in part the CDC supposedly did this by creating a “revised analysis plan”. From the complaint:

Over the ensuing months and in contravention of the CDC’s own policies,10 they deviated from the Analysis Plan and introduced a “revised analysis plan”11

Wakefield and Hooker can’t provide us with that revised analysis plan. Here is reference 11 noted in the quote above:

11 See original notes of Dr. William Thompson of 9.6.2001: “Get revised analysis plan from Tanya.” Tanya Bashin – a relatively junior member of The Group – was the second author named on the DeStefano 2004 paper. [Exhibit 8] The revised analysis plan itself is not available

I discussed this recently as well. It’s not after “ensuing months” that Mr. Thompson wrote about the “revised” plan. It’s not after the data were analyzed (which the earliest dates given by the complaint are in November).  The comment attributed to Mr. Thompson is dated September 6, 2001, the day after the plan was finalized.

Or, to put it another way: Mr. Wakefield and Mr. Hooker–the revised analysis plan is indeed available. It’s the one you are working from, dated Sept. 5, 2001.

In their complaint, Mr. Hooker and Mr. Wakefield disclose private details about Mr. Thompson which frankly have no real bearing on the complaint and should not have been disclosed.

The complaint is long, but it all hinges on the three major claims: (1) The CDC was supposed to do an analysis of the total group (not just the birth certificate group) by race, (2) that the CDC hid results on “isolated” autism and (3) that they deviated from their analysis plan, introducing a revised plan, to do this.

All three claims are false. And not false as in “I interpret them differently” but false as in “the very data Wakefield and Hooker depend on show them to be fabricated claims”.


By Matt Carey

note– I made significant changes for clarity after this was first put online.

A new Autism Media Channel video. A chance to watch some sleight of hand

17 Oct

Andrew Wakefield has a new video with stunning new revelations of malfeasance by the CDC. Well, that’s what he wants you to think. Let’s take a look and see how well his story stands up to scrutiny, shall we? To do this I’ll highlight two of the problems with the video.  The first I’ve already discussed some: Mr. Wakefield claims the CDC hid a result but the CDC actually published it. For the second problem, let’s follow Mr. Wakefield as he creates a timeline showing us how the CDC’s research plan was supposedly revised in response to some analysis results.  Then let’s piece together the real timeline.

We will start with problem one. The basic idea of Mr. Wakefields argument in his new video is that the CDC hid an association in a group of kids allegedly susceptible to becoming autistic due to the MMR. This group are those with “isolated autism”: autism without intellectual disability, birth defects or other possible cause.

There’s a lot of smoke and mirrors in the video, but here’s the main result.  An increased odd ratio for “isolated autism” for kids vaccinated before 36 months.  Calculated odds ratio is 2.48.  With a confidence interval that doesn’t span 1 (1.16 to 5.31).

Wakefield smoke and mirrors

There’s much drama in the video about this.  For example, here’s what Brian Hooker had to say (about 3:25 into the video).

What CDC employees do, when they see an effect, then they will get in a room together and they will work until that association goes away

Followed by Mr Wakefield:

But that didn’t seem to happen. They deviated further from the analysis plan by limiting the isolated group to only those with no mental retardation. Even changing the age categories and composition of the isolated subgroup may not have achieved the desired effect. Since, in the end, the simply omitted the relevant findings from the paper altogether.

That’s an amazing claim, isn’t it? The CDC allegedly just buried the result.  “Omitted the findings altogether.”

Except that the CDC didn’t hide the result. They reported on autism without MR. Here’s table 4 from the paper in Pediatrics.

Destefano_table_4 highlighted

If you want to say, “well autism without MR isn’t the same thing as ‘isolated autism’, consider this: the answer is basically unchanged from what Mr. Wakefield claims was “omitted”.   Take a look at the table: in the total sample, the group without MR has basically the same result as was supposedly hidden.   Odds ratio 2.45 (compared to 2.48), with confidence interval from 1.20 to 5.00 (compared to 1.16 to 5.31).  Which is to say: the CDC published the result that Mr. Wakefield claims was hidden.

Smoke.  Mirrors.  Wakefield.  Hooker.

This result is 10 years old.  And no one, not Wakefield, Not Hooker, not anyone in the real advocacy community has made a big deal out of it until now. I do not profess to understand how Mr. Wakefield nor Mr. Hooker think, but here’s one reason why most people haven’t considered this “autism without MR” result a big deal:  this is a raw data result.  A result unadjusted for any possible confounders.  The adjusted result, also highlighted in the figure above, shows a confidence interval that spans 1.  In other words, there’s no suggestion of a real effect when one does a full analysis.

Which of course shows us why people do full analyses.  Sometimes associations change when one controls for other factors.  Sometimes associations get stronger.  Sometimes they go away.  Sometimes things that appear to not be associations are shown to be associations.

Now that we’ve seen that the conclusion from Mr. Wakefield’s video is wrong, let’s consider a second problem with this new video: the way in which Mr. Wakefield manipulates his audience.  He creates a timeline for the CDC’s actions that allows Mr. Wakefield to use his new favorite “f” word.  Fraud.  Let’s go through the timeline.

At about 2:20 in the video, Mr. Wakefield shows us a fraction of a page of the analysis plan. The protocol. Dated September 5, 2001.

draft analysis plan screenshot

We then get this ominous voiceover. Complete with the analysis plan page going up in flames. Very dramatic:

“Over the ensuing months, after the data after the data had been collected and analyzed, and strictly forbidden in the proper conduct of science, the group abandoned the approved analysis plan, introducing a revised analysis plan to help them deal with their problem.”

And to “prove” that months later the CDC introduced a new analysis plan we are shown notes supposedly documenting that the CDC team were creating that revised plan:

Scary Revised Analysis Plan Screenshot

You are supposed to say, “they revised the analysis plan!  That’s bad!” But do you see what I see? That these are notes from September 6, 2001 2011?  Not after the “ensuing months” but one day later after the plan was finalized. I guess we weren’t supposed to look at the date, just the scary words “revised analysis plan”.

From these notes it appears to say that there will be a records review on September 12th and that in advance of that, whoever wrote these notes needs to get the revised analysis plan. Not, “hey, let’s fabricate a new analysis plan” but, “Hey, the plan was revised yesterday and I should get a copy”. Or, to put it another way: how sinister does the note read sound when the plan was just finalized the day before?

So, when did the CDC do the analysis that Mr. Wakefield shows in his video?  You know, the analysis that the “revised” plan was supposed to avoid?  November, 2001.  Two months later after the plan was finalized and, importantly, two months after those notes were taken. Here’s a screenshot from a talk Mr. Hooker recently gave about his work and the DeStefano paper.  He showed one of the same tables that Mr. Wakefield uses in his video (29:11 into the video).  Notice the date? November 7. In the audio he says “they did see a statistically significant result as early as November 7th, 2001”.  Mr. Wakefield’s first video (the ugly, race-baiting one) also references the November 7th meeting.  So it looks like this is the earliest evidence Mr. Wakefield and Mr. Hooker have  of the CDC obtaining results for this study.

Hooker_CDC

Now, let’s compare how Mr. Wakefield presented a chain of events and what actually happened.

The impression Mr. Wakefield gives in his video is that:

(a) first the plan for the research was finalized by the CDC team,

(b) then they found data which showed an effect they didn’t like and

(c) after “ensuing months” the CDC team then held a meeting in which notes were taken that they had to revise the plan.

Here’s what the actual events appear to be

(a) the research plan was finalized on Sept. 5,

(b) on Sept. 6, someone (likely Mr. Thompson) took notes that he had to get the revised plan and

(c) on November 7, what appears to be the first pass at data analysis were presented presented in an internal CDC meeting.

No evidence of revising the plan after the analysis.  The image of the meeting notes are being used as props to craft a story. Andrew Wakefield apparently doesn’t understand the first rule of documentaries.  And apparently whatever ability he had for reporting factually has long since faded since he left grad school.

And, Brian Hooker?  He’s not just a prop in these videos.  He’s an active participant.  His organization has paid Mr. Wakefield for at least the first video.  The race-baiting video.

The autism communities deserve better. Better than Andrew Wakefield.  Better than Brian Hooker.

By Matt Carey

A look at the analysis plan for DeStefano’s MMR study: no evidence of fraud

16 Oct

Andrew Wakefield and Brian Hooker have been making claims that the CDC are involved in misconduct in autism research. In case you haven’t followed the story, it basically goes like this:

1) the CDC planned on a study of MMR and autism using the MADDSP data.

2) That the CDC created a research plan.

3) That the CDC found results they didn’t want to report: an calculated odds ratio for African American boys. So the CDC team allegedly deviated from that plan and didn’t report that result.

4) That the CDC introduced a new analysis after the plan: that they would include birth certificate data.  While the CDC rationale for this new analysis was to provide more data (confounding variables) for the analysis, the allegedly real reason was to dilute the sample set and make statistically significant results disappear.

Here’s a paragraph from one of the press releases about the Hooker study:

According to Dr. Thompson’s statement, “Decisions were made regarding which findings to report after the data was collected.” Thompson’s conversations with Hooker confirmed that it was only after the CDC study coauthors observed results indicating a statistical association between MMR timing and autism among African-Americans boys, that they introduced the Georgia birth certificate criterion as a requirement for participation in the study. This had the effect of reducing the sample size by 41% and eliminating the statistical significance of the finding, which Hooker calls “a direct deviation from the agreed upon final study protocol – a serious violation.”

Or so goes the story. But as is often the case with Andrew Wakefield and Brian Hooker, the facts don’t match the claims.

In a recent video, Mr. Wakefield shows us the research plan the CDC had drafted.  One red flag with Mr. Wakefield’s approach so far has been how he tries to tightly manage the flow of information.  He has not shared the analysis plan in total and only now has he provided us with a couple screenshots.  Begs the question: what are they hiding?

Here’s one screenshot from that video. This one is where he gets the idea that the plan was to report race for the entire sample.

draft analysis plan screenshot 2

Here’s the full text, in case that’s difficult to read:

Statistical Analysis

We will use conditional logistic regression stratified by matched sets to estimate the odds ratios for association between age at MMR vaccination and autism. In the main analyses, we will include all autism cases.

Potential confounding variables will be evaluated individually for their association with the autism case definition. Those with an odds ratio p-value < 0.20 will be included as covariates in a conditional logistic regression model to estimate adjusted odds ratios for the association between age at vaccination and autism. The only variable available to be assessed as a potential confounder using the entire sample is child’s race. For the children born in Georgia for whom we have birth certificate data, several sub-analyses will be carried out similar to the main analyses to assess the effect of several other potential confounding variables. A recent case control study (CDC, 2001) carried out with a subset of the autism cases from this study found that age matched cases and controls differed on several important background factors including maternal age, maternal education, birth type, and parity. The variables that will be assessed as potential confounders in this study will be birth weight, APGAR scores, gestational age, birth type, parity, maternal age, maternal race/ethnicity, and maternal education. (See Table 2 for how variables will be categorized.)

There are two interesting points in the above.  First, the sentence Mr. Wakefield highlights doesn’t say what he claims.  The only variable available to be assessed as a potential confounder using the entire sample is child’s race. The plan doesn’t say that they will test and report race.  Consider the context: this is a section of the plan called “statistical analysis”. Put in context with the entire paragraph, this sentence is clear: the full dataset is limited because it only has one variable available.

The CDC didn’t deviate from the plan when they didn’t report on race for the total sample because that was never in the plan.  If you want more evidence of this, the end of the paragraph says “See Table 2 for how variables will be categorized”.  Table 2 is titled “Descriptive Statistics for Children Born in Georgia with Birth Certificate Records”.  The variables will be categorized in the birth certificate sample.

The second interesting point from the paragraph Mr. Wakefield has shown us is this: the CDC plan included a birth certificate sample.

Here’s a screenshot of the analysis plan from that new video, showing the front page of the analysis plan:

draft analysis plan screenshot

Shown with this voice over by Mr. Wakefield (while the screenshot above is shown going up in flames…very dramatic)

“Over the ensuing months, after the data after the data had been collected and analyzed, and strictly forbidden in the proper conduct of science, the group abandoned the approved analysis plan, introducing a revised analysis plan to help them deal with their problem.”

So, in case you were thinking, “that’s an analysis plan, how do we know it’s the analysis plan”, well, you have Mr. Wakefield’s word on it.  This is the “approved analysis plan” that the CDC allegedly had to revise.

What interests me about this as that’s the same plan that I have and was preparing to write about.  It’s nice now to be able to be able to say that this is, indeed, the same document that Mr. Wakefield and Mr. Hooker are working with.

We’ve already seen two big mistakes by the Wakefield/Hooker team: first that the analysis plan doesn’t include a call to report on race separately in the total sample (the group without the birth certificates), second that the CDC “approved analysis plan” included analysis of a subset with birth certificate data.

So, what were the objectives of the study as in the plan?

Objectives:
We did not have information regarding onset of symptoms for most cases in this study and this limited our ability to do certain types of analyses such as case series analyses. In addition, a totally unexposed group (i.e., never received the MMR vaccine or other measles containing vaccine) was not available since measles, mumps, and rubella vaccination are required for school attendance in Georgia. The following objectives are considered the primary objectives for this study.
1) To determine if case children were more likely than their matched controls to have been vaccinated with MMR before 36 months of age. DSM-IV criteria for autism require that onset of symptoms occur before 36 months of age. Therefore, the 36-month cut-off is one that by definition can be used to classify a definitely “unexposed” group.
2) To determine whether there was a difference between cases and controls in the proportion of children exposed to their first dose of MMR vaccine before 18 months of age. This objective is based on the research that suggests the timing of first parental concern for the development of autism appears around 18 months of age (Taylor et al, 1999). In addition, Cathy Lord has reported that the range of first parental concern for regression was between 12 and 23 months of age with a mode of 19-21 months.
3) To determine whether the age distribution for receipt of the MMR vaccine differs between cases and controls.

They showed the data for the 36 and 18 month cutoffs.  Age distribution was covered in Table 2.

Analysis of Autism subgroups

The IOM (2001) specifically recommended additional research regarding autism subgroups and MMR. We will examine several subtypes of autism in this study. Data from the Metropolitan Atlanta Congenital Defects Program will be included in the sub-analyses to identify particular sub-groups. The following sub-group analyses will be conducted:

1) Analyses excluding cases with an established cause for autism or a co-occurring condition suggesting an early prenatal etiology (e.g., tuberous sclerosis, fragile X, or other congenital/chromosomal anomalies.)

We propose to conduct a case-control sub-analysis looking at cases without an established or presumptive cause for autism, such as tuberous sclerosis, fragile X, and other congenital/chromosomal anomalies. The purpose of doing this analysis is to create a more homogeneous case group that may be more likely to be impacted by the timing of the MMR vaccine. The objectives from the primary analyses will be replicated in this sub-analysis.

2) Analyses of Isolated versus Non-isolated Autism.

Isolated autism cases are cases with no other co-morbid developmental disability while non-isolated cases do have a co-morbid developmental disability. Previous research suggests that the majority of non-isolated cases have a co-existing developmental disability of mental retardation (CDC, 2001). Both isolated and non-isolated cases will be compared separately to controls. The objectives from the primary analyses will be replicated in this sub-analysis.

3) Analyses examining Gender Effects

Males are at substantially higher risk for autism and may be more vulnerable to the exposure associated with the MMR vaccine. We will analyze males and females separately and replicate the main objectives of the primary analyses as well as examine the potential confounders available from Georgia birth certificates.

4) Analyses excluding autism cases with known onset prior to 1 year of age.

For a subset of autism cases, we were able to identify the timing of parental concern. This sub-analysis will exclude all cases excluded with an established or presumptive cause for autism (e.g., tuberous sclerosis, fragile X, and other congenital/chromosomal anomalies.) and children for whom we have been able to identify first parental concern prior to 12 months of age.

Just in case anyone reading this is one of the few that has been following Mr. Wakefield’s video releases: in a new video Mr. Wakefield is trying to claim that the isolated autism subanalysis was not done.  Except that it was.  They made a minor change to autism without MR, which gave essentially the same result that Mr. Wakefield claims was hidden.

Destefano_table_4 highlighted

Autism without MR has an odds ratio of 2.45 with a 95% confidence interval of 1.20 to 5.00.  I’ll write about this new video soon as there’s much sleight of hand going on, but Mr. Wakefield is claiming that a result of odd ratio = 2.48 with confidence interval of 1.16 to 5.31 was not reported.  Besides ignoring the fact that the data were reported by the CDC, Mr. Wakefield ignores the fact that these are raw-data results.  Total sample, unadjusted analysis.  In the adjusted analysis the result does not suggest an association.

But, getting back to the main point: the claims of fraud are just not founded on fact.  The two main claims of “fraud” are just wrong.  The analysis plan did not state that they would do a subanalysis by race for the total sample.  The addition of the birth certificate data is in the plan, not in some sort of revision.  And Mr. Wakefield and Mr. Hooker knew this.

I am reminded of a quote from an ABC News article recently

“There are always going to be those people at the edges of science who want to shout because they don’t want to believe what the data are showing,” said Dr. Margaret Moon, a pediatrician and bioethicist at Johns Hopkins Berman Institute of Bioethics. She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

“It’s not good. It’s not fair. It’s not honest. But it’s savvy,” Moon said.

By Matt Carey

ABC News covers Brian Hooker’s study: Hooker “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

10 Oct

A recent ABC story (How a Now-Retracted Autism Study Went Viral — Again) discussed Brian Hooker’s flawed and retracted study.  Here are the first few paragraphs:

An autism study that was slammed by experts and retracted this week by its publisher is still alive and well on the Internet, thanks to what critics are calling a perfect storm of lax publishing standards.

Experts say the lone study author played fast and loose with statistics to show a link between autism and the MMR vaccine for measles, mumps and rubella, some experts going as far as saying that the author deliberately did this, but the dubious results took off online anyway, quickly going viral.

“There are always going to be those people at the edges of science who want to shout because they don’t want to believe what the data are showing,” said Dr. Margaret Moon, a pediatrician and bioethicist at Johns Hopkins Berman Institute of Bioethics. She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

“It’s not good. It’s not fair. It’s not honest. But it’s savvy,” Moon said.

Good to see this coming from outside the blogOsphere. Let’s pull one sentence out for emphasis, shall we?

She said she thought the study author “manipulated the data and manipulated the media in a very savvy and sophisticated way.”

When people ask about data manipulation and the MMR/Autism story, there it is.

The story continues at ABC: How a Now-Retracted Autism Study Went Viral — Again. Included in the story is a CDC statement that I’ve seen before but warrants quoting here.

Centers for Disease Control and Prevention statement regarding Brian Hooker’s reanalysis of its 2004 study Aug. 27, 2014

There was no cover up. The study did not find any statistically significant associations between age at MMR vaccination and autism. In the CDC paper, similar proportions of case (children with autism) and control children (no autism) had been vaccinated before 18 months or before 24 months. While slightly more children with autism (93.4%) than children without autism (90.6%) were vaccinated between 24 and 36 months, this was most likely a result of immunization requirements for preschool special education program attendance in children with autism.

As this topic was so sensitive and complex, the CDC study published in Pediatrics in February 2004 underwent clearance at CDC, the usual process of internal review for scientific accuracy that all CDC papers undergo. In addition, before submission to the journal, the manuscript was reviewed by five experts outside of CDC and an independent CDC statistician (see acknowledgements section of the paper for specific names). Finally, all reputable journals undergo peer-review of all submitted papers before final publication.

The 2004 CDC study was designed as a case-control study. This means, children with autism (cases) were specifically identified, and children without autism (controls) were identified to be similar to the children with autism in other respects. When data are collected in a specific way for a specific type of statistical analysis (a case-control study in this instance), using those data in a different type of analysis can produce confusing results. Because the methods in Dr. Hooker’s reanalysis were not described in detail, it is hard to speculate why his results differed from CDC’s.

Since the 2004 Pediatrics paper, CDC has conducted additional studies of vaccines and autism. In 2004 the Institute of Medicine reviewed published and unpublished findings from the US and other countries and concluded that there was no association between MMR vaccination and autism. In 2011, another IOM committee reviewed additional research, and once again found that evidence favored rejection of this association.


By Matt Carey

Retracted: Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data

5 Oct

About two months ago an autism parent published a study: a “reanalysis” of a CDC dataset. That study: Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data.

Here’s a screenshot of how the article looks online today (click to enlarge):

BadStudyRetracted

The retraction reads:

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.

Previously, the editors had an “expression of concern” about the article:

The Publisher of this article [1] has serious concerns about the validity of its conclusions because of possible undeclared competing interests of the author and peer reviewers. The matter is undergoing investigation. In the meantime, readers are advised to treat the reported conclusions of this study with caution.

Further action will be taken, if appropriate, once our investigation is complete.

Comment on

Brian Hooker. Measles-mumps-rubella vaccination timing and autism among young African American boys: a reanalysis of CDC data. Translational Neurodegeneration 2014, 3:16.

An excellent discussion of this study and the questions raised by it can be found at MMR, the CDC and Brian Hooker: A Guide for Parents and the Media


By Matt Carey