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Here’s one part of Brian Hooker’s “reanalysis” that shows just how cynical the anti vaccine movement is

18 Dec

When my kid was diagnosed autistic I started reading research papers (I am a Ph.D. researcher by profession) and the raw data. One thing that struck me immediately was the fact that minority children are much less likely to get a diagnosis than white kids. And minority kids are diagnosed later.

This inequity really bothers me. Accurately identifying the needs of a disabled child can focus the appropriate therapies and supports on that child. The need to rectify this inequity is 100% accepted within the autism advocacy and research communities.

This inequity poses a problem to people who claim that autism is an “epidemic”. If we are not identifying all the autistics in any given group (we aren’t), autism prevalence numbers are inaccurate. Being inaccurate, how does one compare, say, one CDC prevalence number with one 2 years later and claim a “real” increase?

One can’t. Plain and simple.

So, for years, groups like those promoting the idea that autism is caused by vaccines have not only ignored this inequity, they have actively denied it. They are stuck between accepting that the data can’t show an epidemic, or accepting that minorities have some sort of protection from this supposed “autism as vaccine injury”.

When was the last time you read something from, say, the Age of Autism blog or Andrew Wakefield calling for efforts to end this inequity? You haven’t. They don’t do it. When have you heard from someone like Brian Hooker that we should study minority populations to see what “protects” them from “vaccine injury”? You haven’t.

Who is Brian Hooker? Brian Hooker is a parent of an autistic child. Brian Hooker strongly believes that vaccines cause autism. He can back this up with his observations of his child’s development. Observations which are contradicted by his child’s medical records. I discussed this before as Double checking Brian Hooker’s story in VAXXED. A Special Master (a judge in the vaccine court) put it very strongly:

After studying the extensive evidence in this case, I am convinced that the opinions provided by Petitioners’ experts in this case, advising the Hooker family that there is a causal connection between SRH’s vaccinations and either the initial causation or aggravation of SRH’s ASD, were quite wrong.

In the original, the Special Master emphasized “quite wrong“.

So, we have someone who believes vaccines cause autism to the point of ignoring the facts in front of him.

A few years ago Mr. Hooker “reanalyzed” some data from an old CDC study, suggesting that evidence showed that the MMR vaccine might increase risk in African American boys. That was discussed in great detail here and elsewhere. (for example: Brian Hooker proves Andrew Wakefield wrong about vaccines and autism and MMR, the CDC and Brian Hooker: A Guide for Parents and the Media).

Mr. Hooker’s study was retracted. In the research world thats a big deal. As in, embarrassingly bad.

Recently, as in 4 years after his original study, Mr. Hooker republished his “reanalysis”. In the Journal of American Physicians and Surgeons. I’d be completely embarrassed to have a paper in that journal, to be blunt. A lengthy discussion of this reappearance of the study can be found at Respectful Insolence as Brian Hooker’s antivaccine pseudoscience has risen from the dead to threaten children again.

Let me just focus on how Mr. Hooker, in my view cynically, abuses the African American community in order to attack vaccines. From the website of an organization Mr. Hooker belongs to (the ironically–to be polite–named “Children’s Health Defense”), we read this:

Main Points from Reanalysis:

The rate of autism diagnoses has increased alarmingly in the U.S., and is about 25 percent higher in black children. Boys are far more likely than girls to receive this diagnosis.

…

This is not only wrong, it’s wrong in a way that points to incredible dishonesty.

This first point is that autism is about 25% higher in black children. A “main point from the reanalysis”.

Tell me, when you read that did you think, “this study found that autism is more prevalent in African American children”? If so, you were misled. The 25% higher prevalence is from a different study than Hookers. And that other study says something completely different.

From the Hooker study:

However, one study showed that prevalence of autism in African-Americans was approximately 25% higher than that of whites when the data were adjusted for socioeconomic factors[7].

Reference [7] is Socioeconomic inequality in the prevalence of autism spectrum disorder: evidence from a U.S. cross-sectional study.

The Socioeconomic Equality study states:

Also notable is that, although the overall ASD prevalence was higher among non-Hispanic White and Asian children than among non-Hispanic Black or African-America and Hispanic children, when the results were stratified by SES, we saw that the racial/ethnic differences in prevalence varied by SES (Table 3). The lower prevalence among non-Hispanic Black or African-American and Hispanic children was seen only in the low SES category, and the fact that more non-Hispanic Black or African-American and Hispanic children live in poverty contributed to the lower overall prevalence among these groups.

Emphasis mine. Overall ASD prevalence was lower for African American children. Not 25% higher. This lower prevalence was due to lower socioeconomic status. I.e. poverty.

Want to see this a different way? Here’s a figure from the paper (click to enlarge):

The overall prevalence in White non-Hispanic kids was 6.9/1000. For black non-Hispanic kids it was 5.7/1000. About 20% lower. Not 25% higher as Mr. Hooker claims.

Fewer African American kids are getting autism services. Not because they aren’t autistic, but because their poverty keeps them from getting a diagnosis.

This is something we should be working towards fixing. No question. But don’t look to the anti-vaccine community to care or act. It’s an inconvenient fact for their epidemic story.

I guess he has such a low level of respect for the people in his own community (those who believe vaccines cause autism), that he thought no one would check this.

By the way, this paper isn’t the only one that shows a lower autism prevalence among African Americans. You know those CDC autism prevalence reports that come out every two years? Every single one has reported a lower prevalence among African Americans. Every one.

Here’s a line from the latest report:

Previous reports from the ADDM Network estimated ASD prevalence among white children to exceed that among black children by approximately 30% in 2002, 2006, and 2010, and by approximately 20% in 2008 and 2012.

When I saw the claim on Hooker’s organization’s website I figured he must have cherry picked a study that shows what he needed to make his story work. It’s just such common knowledge in the autism community that African Americans get diagnosed less frequently. It’s in every CDC report. I didn’t know he wasn’t cherry picking, he was just misrepresenting the study entirely.

I discuss this as a scientist. He “misrepresented the study”. My father had a word for that sort of behavior: lying.

OK, Brian. You’ve read the studies and decided to do nothing about the fact that many autistic African American kids aren’t getting identified and getting appropriate services. I get that, you have your own cause. But, really, is that community so much of a nothing to you that you can just use them like this? I ask rhetorically. You and your community have always acted with callous disregard.

I once had hope that as it because completely obvious that you and your community were wrong (and that was many years ago), you’d join the actual autism community and put your advocacy to use. I now know that will never happen. And, frankly, we don’t need dishonest people.

—
By Matt Carey

Court Clarifies: Hannah Poling case “does not afford any support to the notion that vaccinations can contribute to the causation of autism”

8 Jul

One of the most common arguments in the “vaccines-cause-autism” discussion involves the case of Hannah Poling. Miss Poling is autistic and was compensated by the government through the vaccine-court system. Online discussions usually end up going around in circles with people explaining why the concession doesn’t mean the government has stated that vaccines cause autism, and the other side saying “but it does”.

Well, the Court has clarified the situation. Here is a footnote from the decision in Brian Hooker’s case.

I am well aware, of course, that during the years since the “test cases” were decided, in two cases involving vaccinees suffering from ASDs, Vaccine Act compensation was granted.
But in neither of those cases did the Respondent concede, nor did a special master find, that there was any “causation-in-fact” connection between a vaccination and the vaccinee’s ASD. Instead, in both cases it was conceded or found that the vaccinee displayed the symptoms of a Table Injury within the Table time frame after vaccination. (See Section I above).

In Poling v. HHS, the presiding special master clarified that the family was compensated because the Respondent conceded that the Poling child had suffered a Table Injury–not because the Respondent or the special master had concluded that any vaccination had contributed to causing or aggravating the child’s ASD. See Poling v. HHS, No. 02-1466V, 2011 WL 678559, at *1 (Fed. Cir Spec. Mstr. Jan. 28, 2011) (a fees decision, but noting specifically that the case was compensated as a Table Injury).

Second, in Wright v. HHS, No. 12-423, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a
“Table Injury” after a vaccination. However, she stressed that she was not finding that the vaccinee’s ASD in that case was “caused-in-fact” by the vaccination–to the contrary, she
specifically found that the evidence in that case did not support a “causation-in-fact” claim, going so far as to remark that the petitioners’ “causation-in-fact” theory in that case was “absurd.” Wright v. HHS, No. 12-423, 2015 WL 6665600, at *2 (Fed. Cl. Spec. Mstr. Sept. 21, 2015).

The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism. In setting up the Vaccine Act
compensation system, Congress forthrightly acknowledged that the Table Injury presumptions would result in compensation for some injuries that were not, in fact, truly vaccine-caused. H.R. Rept. No. 99-908, 18, 1986 U.S.C.C.A.N. 6344, 6359. (“The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally occur within a short time of
vaccination. The Committee further recognizes that the deeming of a vaccine-relatedness adopted here may provide compensation to some children whose illness is not, in fact, vaccine related.”

While the arguments may still not convince those who wish to believe, the conclusion is clear: The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.

The Special Masters (basically the judges in this special court) are not only the experts in the decisions (they work every day in the court and write the decisions), they are legally bound by the decisions. If a case sets a precedent, they must follow it. Or they will be overturned by higher courts.

I agree that following the logic takes time and effort, but, again, if you don’t have the time to go through that, the conclusion is very clear. And repeated again for emphasis

The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.

—
By Matt Carey

Double checking Brian Hooker’s story in VAXXED

7 Jul

One of the arguments so often given for “vaccines cause autism” is that of “then why do so many parents tell exactly the same story?”

Well, they don’t. As we saw with JB Handley (Which is it, Mr. Handley?) even a single parent can shift and change stories over time. And he’s just one example. But we have also seen many times that once the stories we are told are compared to the facts, like say the medical records or videos in vaccine court, parent recollection is shown to be wrong.

Well, now we have Brian Hooker’s two stories. We have what he says in Vaxxed, and we have his recent vaccine court case. An in-depth legal analysis is provided by Prof. Dorit Reiss as BRIAN HOOKER’S VACCINE INJURY CLAIM DENIED BY NVICP.

From the video from Vaxxed, we hear Brian Hooker describe his son’s story starting at 3:26.

My son [SRH] was born in [month] of [year].

(home video with Brian Hooker saying: “[SRH] what does the cow say?”).

(second home video: Brian Hooker: “tweet tweet”, SRH vocalizes which parents interpret as “doggie”).

“Two weeks after his 15 month vaccines, then he lost all language. He lost all eye contact. You would pick him up and he would just hang limp.”

That’s pretty dramatic. And the sort of story that convinces many that, yes, indeed, vaccines might cause autism.

But ask this question, if this happened, why doesn’t Brian Hooker’s son’s medical record say anything like that?

From the Court’s decision, we see that the medical records show that Brian Hooker’s son was already delayed at 15 months. In fact, he was already showing signs of delays at 4 months. First, to be clear: Brian Hooker’s argument before the Court changed with time, and this can lead to some confusion. He first argued that one set of vaccines caused his child’s autism. When the Court informed Mr. Hooker that his cases was filed after the statute of limitations (filed more than 3 years from when the alleged vaccine injury occurred), Mr Hooker amended his complaint to add the claim that the 15 month vaccines (the ones he appears to be referring to in Vaxxed) “aggravated” the ASD as well. Since this event was later, it was not “untimely filed”.

In the end the court found that Mr. Hooker’s claims failed on their merits, so timely or untimely filed didn’t matter.

That all said, here’s an excerpt from the Court’s decision that discusses the 15 month vaccinations:

SRH received his 15-month well child examination on [DATE], and was found to be “healthy.” (Ex. 35, p. 13.) However, at this visit his developmental progress chart indicates that SRH had not achieved most of the expected milestones. (Id., p. 24.) His Denver II developmental progress chart indicates that he could not speak six words, could not run or climb stairs, could not remove garments or use a spoon, and could not stack two cubes, — indeed, he failed all but one of the developmental milestones for 15 months. (Id.) Following a physical examination of SRH, Dr. Heller-Bair administered the usually recommended vaccinations — i.e., DTaP #4, Hib #4, and OPV. (Id., pp. 13, 26.) (These vaccinations of [DATE], were the vaccinations that Petitioners now allege to have “significantly aggravated” SRH’s autism.)

OK, that’s the 15 month vaccination visit. But as to “two weeks after his 15 month vaccines” that Mr. Hooker describes in Vaxxed? What does the record show happened? The Court transcript reads:

Nineteen days later, on [DATE], both parents accompanied SRH to the pediatrician’s office, where she recorded that his temperature was 101.8°, and that both tympanic membranes appeared normal. (Ex. 35, p. 14.) She included the following description.

One-year-old with 1-day history of low-grade fever, irritability, decreased appetite, nasal congestion. Child has a history of recurrent ear infections. Is scheduled for typanostomy tube placement by Dr. Fong in about 4 days’ time. Mom is concerned that he may have an ongoing ear infection prior to surgery.

(Id.) No other recent symptoms were noted. Dr. Heller-Bair determined that SRH had a viral upper respiratory infection — in other words, “a cold” — and reassured the parents that he did not have an ear infection. (Id.)

Emphasis added. And now repeated: no other recent symptoms were noted. Not “he lost all language”. Not “he lost eye contact”. Not “he was hanging limp”.

As to signs of autism before the vaccines in question, we read this (Dr. Leventhal was an expert witness for the government):

Also included in Dr. Leventhal’s list of early symptoms of developmental disorders was another symptom particularly indicative of ASD — “evidence of language delay and reports of social interaction problems” at age 12 months. (Ex. C, p. 30, para. g.) Language delay and social interaction problems, are classic symptoms of autism.

Of course, many will discount this as coming from the government’s expert (even though he’s reporting the medical record).

So, what did the parents have to say?

Third, several representations by the Petitioners themselves indicate that SRH was suffering from developmental problems, likely early symptoms of his ASD, well prior to [DATE–about 15 months]. For example, SRH’s parents reported that at one year of age (about [DATE]), he seemed “delayed in interactive skills.” (Ex. 2, p. 46.) On [DATE], SRH’s parents reported that they had been worried about developmental delays “for about 6 months,” which would put the onset around [DATE–about 13 months]. (Ex. 6, p. 19.) And on occasions, SRH’s parents identified the onset of SRH’s developmental problems as occurring about the time of his MMR vaccination, which took place on [DATE–about 12 months]. (See Ex. 5, p. 30 (SRH lost eye contact “after his MMR shot”); Ex. 14, p. 38 (“delays, deterioration of verbal skills coincidental [with] MMR”)).

Emphasis in the original.

Parents reported loss of eye contact at about 12 months. But in Vaxxed Brian Hooker says his child lost eye contact two weeks after the 15 month vaccinations. So again we see that the stories don’t match up. And recall that Brian Hooker apparently didn’t mention this loss of eye contact to the doctor nor did the doctor notice 19 days after those 15 month vaccines.

Finally, it’s worth noting that pretty much the time that Vaxxed has been touring, Brian Hooker and the rest of those doing personal appearances have known that the Hooker case failed. And let’s not downplay this, the case was not even close. The Court decision includes in the conclusion:

After studying the extensive evidence in this case, I am convinced that the opinions provided by Petitioners’ experts in this case, advising the Hooker family that there is a causal connection between SRH’s vaccinations and either the initial causation or aggravation of SRH’s ASD, were quite wrong.

emphasis in the original.

The experts were quite wrong. The science was the same as was extensively argued in the Omnibus Autism Proceeding, and which failed to come close to being convincing then. The case history showed no sign of vaccine injury or developmental regression. On every count, Brian Hooker’s case failed. But we don’t hear that in the public talks. Why would Brian Hooker, Andrew Wakefield and the rest want to tell the public that not only are the “facts” in Vaxxed wrong, but the science had also been tested yet again and failed yet again? I mean, it’s not like they are calling this a “documentary” or anything. Except that’s precisely what they claim.

—
By Matt Carey

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

22 Mar

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

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

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

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

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

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

Brian Hooker:

My phone rings and it’s Dr William Thompson

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

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

Then a narrator.

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

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

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

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

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

You and I don't know each other very well

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

I have great shame

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

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

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

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

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

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

And this exchange between Hooker and Thompson

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

and

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

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

With friends like Brian Hooker…

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

No. Or, in Thompson’s own words:

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

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

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

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

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

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

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

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

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

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

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

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

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

The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation.

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

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

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

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

—
By Matt Carey

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

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

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

Tags: , , , ,

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

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