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“Statement of William W. Thompson, Ph.D., Regarding the 2004 Article Examining the Possibility of a Relationship Between MMR Vaccine and Autism”

28 Aug

I will discuss this soon, but here is a press release from the attorney representing William Thompson, a CDC researcher involved who appears to have spoken with vaccine antagonistic activists Andrew Wakefield and Brian Hooker about work he had performed on autism.

FOR IMMEDIATE RELEASE-AUGUST 27,2014

STATEMENT OF WILLIAM W. THOMPSON, Ph.D., REGARDING THE 2004 ARTICLE EXAMINING THE POSSIBILITY OF A RELATIONSHIP BETWEEN MMR VACCINE AND AUTISM

My name is William Thompson. I am a Senior Scientist with the Centers for Disease Control and
Prevention, where I have worked since 1998.

I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.

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.

My concern has been the decision to omit relevant findings in a particular study for a particular sub­ group for a particular vaccine. There have always been recognized risks for vaccination and I believe it is the responsibility of the CDC to properly convey the risks associated with receipt of those vaccines.

I have had many discussions with Dr. Brian Hooker over the last 10 months regarding studies the CDC has carried out regarding vaccines and neurodevelopmental outcomes including autism spectrum disorders. I share his beliefthat CDC decision-making and analyses should be transparent. I was not, however, aware that he was recording any of our conversations, nor was I given any choice regarding whether my name would be made public or my voice would be put on the Internet.

I am grateful for the many supportive e-mails that I have received over the last several days.
I will not be answering further questions at this time. I am providing information to Congressman William Posey, and of course will continue to cooperate with Congress. I have also offered to assist with reanalysis of the study data or development of further studies. For the time being, however, I am focused on my job and my family.

Reasonable scientists can and do differ in their interpretation of information. I will do everything I can to assist any unbiased and objective scientists inside or outside the CDC to analyze data collected by the CDC or other public organizations for the purpose of understanding whether vaccines are associated with an increased risk of autism. There are still more questions than answers, and I appreciate that so many families are looking for answers from the scientific community.

My colleagues and supervisors at the CDC have been entirely professional since this matter became public. In fact, I received a performance-based award after this story came out. I have experienced no pressure or retaliation and certainly was not escorted from the building, as some have stated.

Dr. Thompson is represented by Frederick M. Morgan,Jr., Morgan Verkamp, LLC, Cincinnati, Ohio, http://www.morganverkamp.com.

Mr. Thompson has been called the “CDC Whistleblower” by the groups promoting the idea that vaccines cause autism.


By Matt Carey

The Brian Hooker article “…has been removed from the public domain because of serious concerns about the validity of its conclusions”

27 Aug

The paper recently published by Brian Hooker, Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data has been pulled. Currently the journal’s website has this in place of the article:

This article has been removed from the public domain because of serious concerns about the validity of its conclusions. The journal and publisher believe that its continued availability may not be in the public interest. Definitive editorial action will be pending further investigation.

I wish they had thought this through before publishing it. Be that as it may, my own view (as an author and one-time editor) is that the revelation that this is not an original work by Mr. Hooker should have warranted some action. Mr. Hooker has discussed how the idea to do this study came from someone else and the analysis is a recreation of a previous analysis. Minor point, I know. And I know my online friends did not agree with me on that.

I do appreciate the journal taking this step. While Mr. Hooker, Andrew Wakefield and their team try to make as much political hay out of this paper as they can.

More discussions of this paper

Autism, Atlanta, MMR: serious questions and also how Brian Hooker and Andrew Wakefield are causing damage to the autism communities

Here’s the press release for the recent reanalysis study

Here’s a discussion of that study by an epidemiology grad student:
Directed Acyclic Graphs and the MMR vaccine doesn’t cause autism

And another discussion of that study from The Poxes Blog:
Andrew Jeremy Wakefield plays video director while African-American Babies die, or something

And Surgeon/Scientist Orac takes on the study and more here:
Brian Hooker proves Andrew Wakefield wrong about vaccines and autism

Educator and Advocate Liz Ditz discusses the PR approach that has been taken by those promoting the study here:
L’affaire CDC-MMR: Hooker, Wakefield, and Focus Autism Accuse African-American Senior CDC Researcher of Being A Race Traitor

And the CDC have a simple statement here:
CDC Statement Regarding 2004 Pediatrics Article, “Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-matched Control Subjects: A Population-Based Study in Metropolitan Atlanta”


By Matt Carey

Autism, Atlanta, MMR: serious questions and also how Brian Hooker and Andrew Wakefield are causing damage to the autism communities

26 Aug

The groups promoting vaccines causing autism have been handed probably their biggest story in a decade. They are claiming, and it seams likely, that a senior CDC epidemiologist came to them with information that a statistically significant result of possible increased autism risk from the MMR in a specific subpopulation was not reported.

I’ll go into a lot of background below, but if you wish to read up about these events:

Here’s the press release for the recent reanalysis study

Here’s a discussion of that study by an epidemiology grad student:
Directed Acyclic Graphs and the MMR vaccine doesn’t cause autism

And another discussion of that study from The Poxes Blog:
Andrew Jeremy Wakefield plays video director while African-American Babies die, or something

And Surgeon/Scientist Orac takes on the study and more here:
Brian Hooker proves Andrew Wakefield wrong about vaccines and autism

Educator and Advocate Liz Ditz discusses the PR approach that has been taken by those promoting the study here:
L’affaire CDC-MMR: Hooker, Wakefield, and Focus Autism Accuse African-American Senior CDC Researcher of Being A Race Traitor

And the CDC have a simple statement here:
CDC Statement Regarding 2004 Pediatrics Article, “Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-matched Control Subjects: A Population-Based Study in Metropolitan Atlanta”

Even with multiple press releases and no doubt other efforts to gain media attention, this story has yet to break out into a mainstream news story. Some alternative news sources and many parent supporters of the vaccine/autism idea have discussed this lack of media attention. And there’s a YouTube video by Andrew Wakefield that I’ll embed below. That video deserves and probably will get it’s own article here on Left Brain/Right Brain. It is remarkably bad.

It has often been said that the parents promoting the idea that autism is a vaccine-induced epidemic are their own worst enemies. As the parent of a multiply disabled autistic child I can say without reservation that these groups are no friends to the majority of the autism parent community either. Nor are they friends to the real majority of our community: autistics. The vaccines-caused-an-autism-epidemic parents have refused to support any research which goes against their idea that autism is a vaccine-induced epidemic. They don’t support research into the prevalence of autism in adults. Likely because they worry that this will show that their epidemic idea is false. In the process we lose the chance to learn from the previous generations of autistics about what has worked and what has not. Information which is critical to this autism parent. These groups have failed to accept that the lower prevalence of identified autism in racial and ethnic minorities indicates that the prevalence numbers we so often hear are not the a true count of the fraction of our population that is autistic. Because to admit that is to admit that they are misusing the numbers they rely upon to claim an epidemic. Their lack of support has hindered attempts to improve identification and get appropriate services for autistics in racial and ethnic minorities. This is a point that is incredibly ironic given the way these groups are framing their recent news as you will see (or have seen if you read Ms. Ditz’ article linked above). On top of this they have produced a way over-the-top PR campaign about their news, demonstrating their deep hatred for the CDC. If I were to tell you that Andrew Wakefield is claiming that the CDC are worse than Adolf Hitler, Josef Stalin and Pol Pot (because, you see, in Mr. Wakefield’s eyes at least those dictators were sincere), would you believe me? Would you think I was making this up? If I said that Mr. Wakefield has played the race card in a disgusting way, claiming that the U.S. vaccine program is a new Tuskegee experiment, would you believe me? You can skip down to the bottom if you want to see that discussion and video. I’ll start with the science.

About 10 years ago a team from the CDC published a study: Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta (full paper here). They took data from the CDC’s Metropolitan Atlanta Developmental Disabilities Surveillance Program (MADDSP). In order to control for potential confounding variables–like mother’s age, birth weight and more, the authors of the MMR follow-up study pulled birth certificate records. They only pulled them for kids born in Georgia. Could be there was a logistics issue (trying to track down records across the country) or if birth records were not consistent across the US. Also, they would have had to find control kids for those born outside Georgia, and that would have been a big logistics issue. In the end there were two analyses presented–one on the raw data with all the kids, and one with a more detailed analysis done with this smaller “birth certificate” cohort.

Here’s an example of one of those analyses (click to enlarge):

DeStefano table 3

This is a good table to review this study. What did they find? The general result is that time of MMR vaccine receipt was similar between autistic kids and non autistic kids, but was statistically more common among autistic kids. In the table above we see that for the most part, the sub groups reported had generally no increased risk of autism with MMR. I.e. in most examples the 95% confidence intervals encompass 1. The unadjusted sample “all cases” and “boys” do not encompass 1. If those were all the data we had, we’d say “let’s look more closely at these”. We’d start with exactly what the authors do–check for confounding variables and see if the effect gets bigger or smaller. In the adjusted data, all the odds ratios encompass one. Some are high enough to warrant a closer look: kids aged 3-5 and boys. Combining these two I’d probably ask, “what about boys aged 3-5”, but the authors take on the age 3-5 question in general in the discussion citing that the 3-5 age group autistics were mostly in special ed preschool and were thus required to have MMR.

If you look at Table 5 (click to enlarge) you see an interesting and very strange trend. It was in the other data but it’s really clear here. The odds ratio is much larger for kids who got MMR before 36 months than for kids who got it before 24 months. The odds ratios still encompass 1, but there is something going on in the data for the kids who got vaccines between 24 and 36 months. And by “something going on” we always have to consider social factors. But take a look:

DeStefano table 5

Take, for example, maternal education. Kids with mothers who had more than 15 years of education had an odds ratio of only 0.61 if their kids got the MMR before 24 months, but that odds ratio jumps up to 2.76 if their kids got the vaccine before 36 months. In both the confidence intervals encompass 1, so we can’t say “MMR before 24 months is protective but MMR before 36 months increases risk”. But that difference is striking. Even if these results were statistically significant, it doesn’t make sense to say, “the MMR vaccine causes autism in kids when it is given between 24 and 26 months if their mothers are well educated. And, by the way, it’s protective if given before 36 months.”

While not as striking, the differences between the unadjusted and adjusted analyses in table 3 are notable. Odds ratios change when you take into account other factors. I’m no epidemiologist, but if this isn’t covered in epidemiology 101 I’ll be stunned. In physics (the field of my Ph.D.) we talk about “hidden variables”. You see one thing correlated with another but in reality a third, “hidden”, variable is actually causing the association.

That said, the CDC MMR paper is not a study without limitations (no study is). One major limitation was the need discussed above–to argue why the 3-5 age group kids had a higher prevalence.

At this point researchers (both the study authors and those reading this paper) and advocates can take a number of approaches. Here are 4:

1) They can say, “yep, that’s plausible enough. We’ve worked this dataset enough. This tells us that MMR doesn’t cause autism. Let’s move on from MMR.”

That didn’t happen and rightfully so. This isn’t a particularly strong study. It’s not the final word and I don’t think it was intended to be. It was a relatively quick study using an existing population. In the end there were more studies on autism and MMR.

2) Advocates and researchers could take the approach: “There’s an association there, but these data are too limited to really answer the question of causation. Can we do a study to nail down if there’s something about those kids born in those specific years (the 3-5 year olds) who got the MMR between 24 and 36 months? Maybe look at further subsets?” And, while it’s easy to say with hindsight, this is the approach that should have been taken in my opinion. I am unaware of work by this team of researchers or external researchers which addressed this question. I am also unaware of calls by the autism community to do such a follow up, by the way.

3) Advocates and/or researchers could say, “I think we can tease more out of these data. Hey, CDC, can I have that dataset to review myself?” Because the CDC did make these data available for serious researchers to review. CDC researchers moved on to other topics in autism and vaccines, but other researchers or qualified advocates could have taken this up.

4) Advocates (not so much researchers I suspect) could say, “I don’t trust the CDC to add 1 and 1. Give me those data and I’ll do the analysis myself. Even those areas where you show a lack of association are probably wrong.” And, yes, there are advocates like that. Well, except that no one asked for the data back then. More recently, though someone did. Which leads us to:

An autism parent and strong proponent of the failed mercury hypothesis, Brian Hooker, recently published a study re-analyzing that old CDC dataset on MMR and autism. His financial backers put out a press release claiming that not only does this study show that vaccines cause autism in a specific subgroup, but that this study was prompted by a CDC “whistleblower”. I.e. someone who was inside CDC and knew about the details of the CDC study was in contact with Mr. Hooker.

That’s a pretty dramatic press release. Let’s take some time on it.

Focus Autism Releases Findings on 2003 CDC Autism Study – Higher Autism Rate Among African-American Boys Receiving MMR Shot Earlier than 36 Months
Focus Autism releases their findings of a possible reduction in the sample size of a major 2003 study conducted by the Centers for Disease Control and Prevention. This sample size reduction negates statistically significant findings from the study.

This title is why I jumped to the press release before talking about Mr. Hooker’s paper. With this title we know (a) that Mr. Hooker is claiming an association among a specific subgroup only (African American boys) and (b) he’s claiming that there was some sort of sleight of hand by the CDC where they reduced the sample size.

Well we already know from the CDC study that autism rates were higher in kids who got the MMR before 36 months. It’s right there in the conclusion statement of the abstract. But not so much before 24 months. And we know autism rates were higher in boys. We didn’t see the analysis narrowed down to African American boys.

The press release states:

“However, CDC researchers did not include any children that did not have a valid State of Georgia birth certificate – reducing the study’s sample size by 41% . Dr. Hooker explains that by introducing this discretionary criteria into the analysis, the cohort size was sharply reduced, eliminating what would have been a higher statistical finding. ”

This is a rather odd statement. And by odd, I mean so obviously false that I wonder why it was written. See for yourself above, the study includes *both* the group with the birth certificate data and the raw data. Mr. Hooker’s explanation is, well, lacking. Sure, it is “discretionary” to try to account for confounding variables. It’s the sort of discretion I expect from epidemiologists. It’s like saying, “the engineers designing the Tacoma Narrows bridge decided against including the discretionary criteria of wind”. Also, consider that a result can be both statistically significant and wrong as is often the case when one finds something “statistically significant” without looking for or correcting for hidden variables.

In another press release Mr. Hooker calls the birth certificate data “irrelevant and unnecessary”. Again, why put out statements that anyone familiar with epidemiology would know to be false?

Elsewhere Mr. Hooker has even challenged the fact that one can obtain the stated data from birth certificates. He is in effect stating that not only is there no point in controlling for such factors, but that the CDC just lied and didn’t even have those data from the birth certificates.

Despite your assertions and the assertions of Destefano, Birth Certificates do not contain the information on the covariates you cite: birth weight, maternal age, maternal education, parity, etc. If you had read my paper, you would see that I repeated the analyses of the CDC and obtained the same results that they obtained in both what was published originally and what was withheld. Also, the birth certificate restriction was NOT applied to other race categories outside of African Americans.

Readers interested in whether Mr. Hooker is correct can take a look at the U.S. Standard Certificate of Live Birth. While this is the revised version, states standardized on birth certificates back in the 1990’s.

Epidemiologists are aware that the piece of paper a parent takes home isn’t necessarily the same birth certificate data that is in the full record.

And “Also, the birth certificate restriction was NOT applied to other race categories outside of African Americans”. Here we see the race card being played. A card that we will soon see was played with a very heavy hand. But to address the assertion made by Mr. Hooker, I wonder how he explains that there are 333 white autistic kids in the “total sample” and 199 in the “birth certificate sample”. Which is to say, his statement is false.

In one of the press releases, Mr. Hooker states

When asked if there could be any scientific basis for excluding children born outside of Georgia, Hooker responded, “I know of none, and none has been provided by the authors of the DeStefano study.”

Again, children born outside of Georgia were not excluded as Mr. Hooker asserts. Analyses were presented on both those born within Georgia (including adjustments for vital statistics found on the birth certificates) and a total sample including those born outside Georgia (the unadjusted analysis). If Mr. Hooker is “unaware” why people would do such an elementary epimiological task as adjusting data with covariates, I suggest he was a poor choice to perform Focus Autism’s study. Another thought would be that Mr. Hooker could read his own paper where he states:

It should be noted that a recent publication has shown that the prevalence of autism in African Americans is nearly 25% higher than that of whites. This value was obtained when CDC data were appropriately analyzed based on socioeconomic status

Mr. Hooker notes that when one does an analysis “appropriately” one includes socioeconomic status (such as with data found in the full birth certificates).

If Mr. Hooker would like to ask why the CDC team didn’t look for birth certificate data on kids born outside of Georgia, that’s would be a better place to start. Then we can discuss whether the CDC would then need 3 controls for each non-Georgia born kid, controls from the same place of birth as the study team did with Georgia born kids. And we could discuss how difficult that would be. And whether that would introduce more problems than it might solve. That’s a reasonable discussion. Claiming there’s no reason to gather important data is not.

Enough of the inconsistencies in Mr. Hooker’s recent statements. What was Mr. Hooker’s method and what did Mr. Hooker find in his analysis? The Poxes Blog and
epidemiologcal.net discuss this with more expertise than I can. Mr. Hooker does not recreate the CDC’s case-control study. That would require that match autistic kids and non autistic kids on the parameters he says aren’t available, and adjust for those same parameters. Instead he does a cohort study without adjustments. As discussed elsewhere, this is a much weaker approach. His main result is as the press release states “Higher Autism Rate Among African-American Boys Receiving MMR Shot Earlier than 36 Months”. He does not note in his press release “no risk for MMR and autism in everyone else”. Here is table 2 from his paper showing that.

hooker table 2

He states a relative risk that is statistically significant for African American boys who get the vaccine before 24 months (RR=1.73) and before 36 months (RR=3.36). No increased risk for African American girls. And, as Table 3 shows, no increased risk for non African Americans.

Mr. Hooker says his results are statistically significant. Others have questioned whether his analysis is really appropriate to say this, but for now let’s just benchmark this by checking how large his sample group for that large relative risk is anyway. Just so we know. The high risk group are kids vaccinated before 36 months. Here’s a figure from Table 2 of DeStefano et al.:

DeStefano table 2

There are 45 autistic kids vaccinated between 24 and 36 months. African Americans account for 40% of the total population, but let’s say about 1/2 of this 24-36 age group are African American. Or about 22 kids. 22 kids and Mr. Hooker is doing no adjustments for factors such as those found on birth certificates. The sort of socioeconomic parameters that he notes are important to get an accurate prevalence in the African American population.

Which is to say: this is not a strong finding by any stretch of the imagination.

Mr. Hooker took a subgroup–African American males–and found that there was in the unadjusted data a statistically significant relative risk. An increased relative risk is not the same thing as showing causation, especially when you are working with unadjusted data and many other limitations in this. This is enough to raise the question of whether we should do more studies to show if this increased risk holds up to further scrutiny. This is how Mr. Hooker concludes his paper:

Routine childhood vaccination is considered an important public health tool in reducing the morbidity and mortality associated with infectious diseases. However, consideration should be made in the current United States vaccination schedule for genetic subpopulations that may be associated with vaccine adverse events. Additional research is required to better understand the relationship between MMR exposure and autism in African American males.

A study relying largely on a small group of subjects (about 20) with the conclusion that more work is needed. Sounds vaguely familiar. And, as we will see, Mr. Hooker has teamed up with Andrew Wakefield to put out a video where they jump past the whole this indicates more research is needed through this is absolute evidence of MMR causing autism directly to the CDC are engaging in a racist experiment sacrificing children to autism. It’s like the events around Mr. Wakefield’s 1997 Lancet paper cranked up to 11.

Even though Mr. Hooker’s analysis is quite limited, as in it would be (and you will see is) incredibly irresponsible to jump from this to say “MMR Causes Autism in African American Males”, I’d like to see either more data or a good explanation why someone shouldn’t do it. If for nothing else, precisely to head off the sort of irresponsible and damaging PR campaign that Mr. Hooker and Mr. Wakefield have engaged in. There are a lot of data on MMR and autism since DeStefano first published (especially Hornig et al.) showing that MMR doesn’t increase autism risk. And Mr. Hooker himself has shown that autism risk is not raised in everyone other than African American boys. One can easily argue (and should) that the MMR/Autism/African American Boys result is spurious. But I’d like to see more evidence to support that. I don’t see evidence so far that this is fraud, but I don’t agree with the scientific decisions made.

All this said, can reasonable people really raise a concern about autism risk given how inflammatory that discussion can be? Yes. Here’s an example of how a study found a possible risk factor and follow up studies answered the question. The Price study was one of the largest studies on thimerosal exposure and autism risk. As part of that study they considered folic acid intake in mothers as one confounding variable for thimerosal exposure. They reported that there could be an increased autism risk from taking folic acid. The calculated risk for mothers who reported taking folic acid was about double that of those who didn’t. Keep in mind that folic acid supplementation for pregnant women is a major public health program as it reduces the risk of some developmental disabilities, so the possibility that it was increasing autism risk has major public health implications. This is a good parallel to the question of vaccines (public health program) and autism.

After the Price study, multiple studies were performed looking folic acid intake and autism risk (I can’t say that these were prompted by Price et al., but it seems reasonable to think they might):

Maternal periconceptional folic acid intake and risk of autism spectrum disorders and developmental delay in the CHARGE (CHildhood Autism Risks from Genetics and Environment) case-control study.

Association between maternal use of folic acid supplements and risk of autism spectrum disorders in children.

How can we summarize the folic acid history? A possible risk factor was found. It wasn’t plausible since folic acid seems to be protective for birth defects. But people did a second check (and even a third) and found that not only is folic acid not a risk factor, it may even reduce autism risk. Which even though this is what people would have said was biologically the most probable outcome at the start, this was a needed exercise.

Can we draw a parallel? Well, DeStefano et al. and later Hooker found a possible risk for MMR and boys (with Hooker citing African American Boys) getting the MMR vaccine late but before 36 months. It doesn’t seem plausible or even self consistent with the other results of the study dataset as has already been discussed. Reasonable people could move forward on this and see if existing data could answer this or if a new study is warranted.

Reasonable people could. As I’ve alluded to, we aren’t really dealing with a “and reasonable people” scenario. And here’s where we get into the “these people are their own worst enemies” part of the discussion. We’ve already seen how Mr. Hooker has made incorrect statements about the birth certificates of the DeStefano study. Let’s look another of Mr. Hooker’s statements and ask, “is this the statement of a reasonable person”?

He added, “The exclusion is reminiscent of tactics historically used to deprive African-Americans of the vote by requiring valid birth certificates.”

And here we see Mr. Hooker and Focus Autism playing the race card for sensational effect. One can’t even say this is a stretch. It’s just ridiculous. There was no exclusion and certainly people didn’t say, “let’s exclude African Americans and deny them their rights.” Maybe some will say this still within the realm of what a reasonable person might say. I would then ask you to watch this video produced to promote this study and the events surrounding it. The really inflammatory statements are made by Andrew Wakefield, but this looks to be a joint effort between Mr. Wakefield and Mr. Hooker. If Mr. Hooker would like to explain that he disagrees with the approach Mr. Wakefield took, I’ll be quick to rewrite this. But for now, here’s what team Wakefield/Hooker has prepared for you:

As promised above here are Andrew Wakefield and Brian Hooker claiming that the CDC are running a Tuskegee like experiment, where in Mr. Wakefield’s view African American boys are allowed become autistic by MMR for some nefarious and unexplained reason (because there are so few autistics that we need to create some for study?). I suspect Mr. Hooker will take offense at me stating that he is claiming this as it’s Mr. Wakefield who says the words. OK. Go ahead and put out a statement distancing yourself from this irresponsible attack Mr. Hooker. And, yes, I wasn’t exaggerating when I said that Mr. Wakefield thinks that the CDC are even worse than Hitler, Stalin and Pol Pot. The dictators, you see, were sincere. (8:40 into the video).

No one has yet responded in the mainstream media to the press releases and the Hooker study. And many of Mr. Wakefield’s supporters online are noticing this and asking why. Here are some possibilities:

1) The press has been burned by 17 years of bad science and unethical behavior by those promoting the vaccine/autism link.

2) perhaps the most famous person in that bad science and unethical behavior is your spokesperson on this new media campaign: Andrew Wakefield.

3) members of the press are not generally attracted to stories where people who have devoted their lives to preventing infectious diseases and to understanding developmental disability are called worse than Hitler.

4) after years of a campaign to instill fear about vaccines, we are in the midst of outbreaks of multiple vaccine preventable diseases. The founder of the blog where Mr. Hooker chose to release and discuss his new results famously once bragged that his groups was going to bring the “U.S. vaccine program to its knees

Mr. Wakefield and Mr. Hooker probably (and some of their followers certainly) have been wondering why their news of a CDC “informant” hasn’t garnered media attention. If you read the press releases and have followed the online discussions, you know that the idea for this reanalysis of the DeStefano data came from documents obtained by Congressman Issa and from phone conversations Mr. Hooker had with a CDC epidemiologist.

In their first press release, Mr. Hooker’s team noted that

According to Dr. Hooker, the CDC whistleblower informant — who wishes to remain anonymous — guided him to evidence that a statistically significant relationship between the age the MMR vaccine was first given and autism incidence in African-American boys was hidden by CDC researchers.

That was released on a Tuesday. The video came out the Monday previous, but was censored and the voice of the “informant” was obscured. On that same Monday, Mr. Wakefield noted on his Facebook page “He will be identified very soon” (referring to the “informant”). In other words, they had no intention of keeping this man’s identity secret. And a few days late, on Thursday night, the video was changed so that the censoring was gone and the voice was not obscured.

So, we have an informant who was obviously working with the Hooker/Wakefield team for months who wanted to remain anonymous. The Wakefield/Hooker team left clues about who this person was: they noted that he works for the CDC and has for some number of years and Mr. Hooker spoke of the informant as “him”. There are only two males who worked on that paper: W.W. Anderson Thompson (who has been named as the informant) and a statistician in the acknowledgments. Which of those two are on record within CDC as having voiced a strong opinion about the African American boy data? Heck, I nearly called Mr. Thompson myself to ask if he was working with Mr. Hooker. I wouldn’t be surprised if people at the CDC figured it out and that’s why his name was so quickly divulged by Mr. Wakefield. Why keep his name secret if you’ve already given out enough information to his superiors for them to break his cover?

And with that let’s get back to the “these guys are their own worst enemies” discussion. When you have someone you consider a whistleblower, it is your duty to protect that person. Not out him/her. Mr. Wakefield doesn’t seem to understand that. Years after having ignored the information given to him by a whistleblower in the UK, Mr. Wakefield not only outed that whistleblower, he first threatened the man with disclosure:

If Mr. Thompson intended to stay anonymous, and I have no reason to suspect otherwise, he chose poorly in his confidants.

Mr. Thompson had many options of to whom he could reveal his information. Many people would have taken him seriously and not taken the highly irresponsible approach that Brian Hooker has with the race-baiting video and more. I’ve read a number of people speculate that Mr. Thompson didn’t know what he was getting himself in to. If he really chose to work closely with Mr. Hooker, I can’t see how he didn’t see the extremes this information would be put to.

Mr. Hooker has had much communication with the CDC over the past decade and more. Here is some of that communication (about 3MB worth), selected by Mr. Hooker himself as an exhibit in his FOIA case with the CDC.
People at the CDC, likely Mr. Thompson included, would know of Mr. Hooker’s very strong opinions of them. A letter sent to then CDC Director Julie Gerberding is entitled “War Crimes in Your Fight Against Infectious Disease and recommends: “I would personally urge you to review the Book of Matthew 18:6 and consider your own responsibility to all children of the U.S. including my own son.” Italics in the original. Here is one version of Matthew 18:6:

But whoso shall offend one of these little ones which believe in me, it were better for him that a millstone were hanged about his neck, and that he were drowned in the depth of the sea.

Former CDC director Gerberding almost certainly did not share this with Mr. Thompson. But Mr. Thompson may have had similar exchanges with Mr. hooker in the past. As I’ve noted above, Mr. Hooker had at least some contact with Mr. Thompson previously. Also, one need only google Mr. Hooker’s name to see that he tends to exaggerate the importance of his CDC FOIA findings, his critiques of vaccine safety science are heavily biased, he is a board member of Focus Autism (Focus Autism was born out of Barry and Dolly’s desire to put an end to the needless harm of children by vaccination and other environmental factors.) and more.

Brian Hooker and Andrew Wakefield present at parent conventions such as AutismOne, where other presenters are selling their goods and services with faux autism treatments. Treatments such as bleach enemas and drinks (MMS), Lupron (a drug which shuts down sex hormone production. Essentially chemical castration), chelation, megadoses of “supplements” and more. They are sold largely on the promise of healing “vaccine injury”. By handing the Hooker/Wakefield team this PR win, Mr. Thompson will be feeding that industry.

This all said, we only have a few sentences on a video purporting to be Mr. Thompson. I have no reason yet to doubt that his his voice. I also don’t have the full conversations in context. Nor do I have evidence that Mr. Thompson agreed to be outed. Nor do I have evidence that Mr. Thompson agreed to have his phone conversations recorded. Nor do I have evidence that Mr. Thompson continues to communicate with Mr. Hooker. In fact he’s been silent since this story broke and no new quotes from him have been passed by Mr. Hooker or Mr. Wakefield.

What’s more, and rather odd, is that MMR is not really either Mr. Thompson nor Mr. Hooker’s primary interest. Mr. Thompson was author on a number of major thimerosal papers. First author on one. Mr. Hooker’s primary focus on the vaccine/autism discussion has been on thimerosal. I have been reading people online claiming that these events are what they’ve expected and hoped for: someone from CDC exposing that all the vaccine/autism work is fraudulent. But this isn’t the case at all. Nothing so far on thimerosal. One re-analysis of some MMR work that, while important to discuss, is not very strong at all. And while I have written what is possibly my longest article yet (out of something like 2000), there isn’t, as they say, much there there when it comes to anything substantial about vaccines and autism. What we do have is a public relations mess. A story that will be exploited by unethical people to frighten parents and try to revamp their own image and take some revenge.

More recently, at least one (non reliable) site is reporting that Mr. Thompson has spoken through his attorney. The message (and I paraphrase): in getting the preliminary result on African American boys out, he did what he set out to do.

In the end, it is once again public health and autism families that will pay the price. People will use this in their attempt to “bring the U.S. vaccine program to it’s knees”. More autism parents will be dragged into the self blame and guilt that comes with the vaccines-cause-autism beliefs. And disabled children will be subjected to abusive faux therapies in attempts to heal their “vaccine injury”.


By Matt Carey

Is Boyd Haley resurrecting OSR#1 as a chelator?

22 Jul

Boyd Haley was a professor of chemistry who was very active in the failed thimerosal-causes-autism movement. He earned extra notoriety for trying to coin the phrase “mad child disease” (yes, a variation of mad cow disease) for autistic children. He also found notoriety for marketing a synthetic chemical as a “nutritional supplement”, calling it OSR#1. Prof. Haley is certainly persistent. He’s working on a clinical trial.

How did this come to pass? Well, one of the professors in Prof. Haley’s department found that a certain compound could effectively treat mining waste, removing mercury. Given his own interests, Mr. Haley started a company with an investor with the intent to bring this chelator to the public. The chelators used in medicine today were developed for lead and have been expanded to also treat mercury. I.e. there is no mercury specific chelator and this new compound would fill that gap.

All well and good, but in his zeal to bring this product to market, Prof. Haley cut a few corners. Chelators are drugs. The compound he was working on was synthetic. But Prof. Haley chose to rush the product to market as a “nutritional supplement”. Instead of calling it a chelator, he called it OSR#1. OSR standing for “oxidative stress relief”. Mr. Haley skipped the process to prove that his drug was safe and effective. Supplements have a much lower standard for safety and efficacy testing.

The FDA was not fooled. Mr. Haley and his company were given a warning letter which pointed out that the compound is not a supplement, it is a drug:

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.

Also that the company was making claims that the drug could treat medical conditions and that the labeling was misleading in this regard. Further, that the toxicity was not adequately tested nor reported.

Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

That was in 2010. Prof. Haley and his company are now back, trying to get a clinical trial started on their compound. Essentially, they are trying to do what they should have done in the first place: get proper approval for a drug. An article in Chemical & Engineering News discusses this effort. Actually, it’s part of the cover story, “Building Pharma Molecules”

buildingpharma

The story on Mr. Haley’s Company, CTI Science, has contracted with another company, PCI Synthesis, to manufacture the new compound.

haley2

The article is, well, a bit of a sales pitch and gets a few facts wrong. There’s a bit of spin on the FDA warning letter, for example:

“The effort to develop the compound as a mercury poisoning therapy accelerated in 2010 when the company received notification from FDA that it couldn’t market NBMI as a nutritional supplement until it underwent the full drug approval process”.

As we’ve just seen above, the compound is not a nutritional supplement at all. It needs the drug approval process because it is a drug.

The CEO of PCI is quoted as stating:

“The main starting material is cysteamine hydrochloride, which is basically an amino acid and found naturally. So it has attributes that could qualify it as a natural product.”

Which was part of the sales pitch for the OSR#1 in the old days and, again, the FDA disagreed. Just because something is synthesized from a natural product, that doesn’t make it a natural product. Otherwise there would be no synthetic products at all. Everything at some level comes from a natural product.

The article discusses how to qualify for a clinical trial the product must meet current Good Manufacturing Practices (cGMP). The article states:

The primary challenge was the removal of impurities to a level that meets cGMP standards

Think about that a moment. Apparently OSR#1 was sold with more impurities than would meet this standard–a standard for food and dietary supplements.

The article notes that, yes, this compound was sold as a product at one time

Sales to date: $1.5 million, as a nutritional supplement

$1.5M in sales. And the only reason it wasn’t higher was because the FDA stepped in. It was only out for about a year, as I recall.

I found this statement interesting, from the Wikipedia page for the compound:

In animal experiments, the amount of mercury in brain tissue was not increased, but also not decreased

So, even if you believe in the failed mercury hypothesis. What exactly were you supposed to get from this compound? I somehow doubt that even the strong believers in the mercury hypothesis think that removing mercury from, say, your liver will cure autism.

It does seem that Mr. Haley and his company are doing some of the right things now. Show that this drug is safe and effective for its intended purpose: chelation. There are some problematical statements that they may market this not as a drug but as a nutritional supplement, which is a non-starter.


By Matt Carey

Comment on “Prenatal and neonatal peripheral blood mercury levels and autism spectrum disorders”

3 Jul

About a decade ago (even longer) there was a question posed as to whether thimerosal (a mercury containing preservative) in vaccines could increase the risk of autism. Many studies have been performed and the answer is no (for example, here).

Even though the question has been approached from multiple angles, research continues. A study out this week takes a look at blood mercury levels in the mother and newborn baby to see if they are correlated with later autism diagnoses in the baby.

California archives blood samples from pregnant mothers and blood spots (cards with a dried spot of blood) from newborns. A team looked at these samples to explore the question: are blood mercury levels in pregnant mothers or newborns correlated with autism.

Short answer: no.

Add this to a MIND Institute study from a few years ago , (Blood mercury concentrations in CHARGE Study children with and without autism) which showed no differences in blood mercury levels between ASD and non ASD preschool children when controlled for diet. And this study from Jamaica again showing no differences. So, while the authors in the recent study suggest a larger study would be valuable, I question whether resources would be wisely spent in that way.

The abstract is below of the new study is below:

Prenatal and neonatal peripheral blood mercury levels and autism spectrum disorders.

BACKGROUND:

Prenatal and early-life exposures to mercury have been hypothesized to be associated with increased risk of autism spectrum disorders (ASDs).

OBJECTIVES:

This study investigated the association between ASDs and levels of total mercury measured in maternal serum from mid-pregnancy and infant blood shortly after birth.

METHODS:

The study sample was drawn from the Early Markers for Autism (EMA) Study. Three groups of children who were born in Orange County, CA in 2000-2001 were identified: children with ASD (n=84), children with intellectual disability or developmental delay (DD) (n=49), and general population controls (GP) (n=159). Maternal serum specimens and newborn bloodspots were retrieved from the California Department of Public Health prenatal and newborn screening specimen archives. Blood mercury levels were measured in maternal serum samples using mass spectrometer and in infant bloodspots with a 213nm laser.

RESULTS:

Maternal serum and infant blood mercury levels were significantly correlated among all study groups (all correlations >0.38, p<0.01). Adjusted logistic regression models showed no significant associations between ASD and log transformed mercury levels in maternal serum samples (ASD vs. GP: OR [95% CI]=0.96 [0.49-1.90]; ASD vs. DD: OR [95% CI]=2.56 [0.89-7.39]). Results for mercury levels in newborn blood samples were similar (ASD vs. GP: OR [95% CI]=1.18 [0.71-1.95]; ASD vs. DD: OR [95% CI]=1.96 [0.75-5.14]).

CONCLUSIONS:

Results indicate that levels of total mercury in serum collected from mothers during mid-pregnancy and from newborn bloodspots were not significantly associated with risk of ASD, though additional studies with greater sample size and covariate measurement are needed.

Copyright © 2014 Elsevier Inc. All rights reserved.


By Matt Carey

Autism an inside job: a webinar by 9/11 truthers and some names you might recognize.

8 Mar

For some reason autism and vaccines attract a certain fringe element. And for some reason certain segments of the autism communities are willing to join forces with this fringe. For example, consider years back when Andrew Wakefield spoke in Ireland with a new world order group at a rally called “The Masterplan: The Hidden Agenda for a Global Scientific Dictatorship”. Given this history I shouldn’t have been surprised when I ran across websites discussing a webinar held last year: “Autism 9.11 – An Inside Job: Vaccines – A Vicious Social Policy”. As you will see, the webinar includes some names that are familiar to those following the failed mercury/autism hypothesis.

Here’s the trailer for the webinar. It’s only three and a half minutes long and it’s annoyingly edited, but give it a watch.

“Born to be free. Vaccinated to be controlled”. Subtle, eh? OK, maybe in comparison to “The great culling had begun”.

In case you curious as to what the “inside job” is, and the 9.11 reference: to this team autism was an “inside job” just like 9/11 was an “inside job”. Yes, we are talking 9/11 truthers. Yes, people who think that the September 11 attacks in the U.S. were orchestrated by the government. Think this is too far out to be true? Think again:

“Is there anyone conscious who does not know that 9/11 was an inside job? Not anyone that I talk to. By now you also know that autism is an inside job as well. The crony corporatists (aka, “globalist elite”) expect to profit handsomely from the genomic disruption of our children.”

From that same page:

And what about the autistic children now becoming adults in the millions, the tragic victims of the Vaccine Big Lie? The Elite have plans for them, since they follow orders if their basic needs are met with predictable routine. They have been made into the perfect worker drones. Dr. Paul G. King told us that the vaccine schedule is being “fine tuned” to produce more “high functioning” autists for the new world order.

Yep. The rise in autism is not only real, but it is a government approved program to create a “Delta” (think Brave New World) class of workers. And, no, I’m not exaggerating.

In case you think you recognize the name in that paragraph, that would be Paul King of CoMeD. CoMeD is a group run by Mark and David Geier, major proponents of the failed idea that mercury in vaccines caused an autism epidemic. And apparently now Mr. King is telling is that “the vaccine schedule is being “fine tuned” to produce more “high functioning” autists for the new world order”.

Let’s take a look at the schedule for the “Inside Job” webinar:

SCHEDULE Autism: An Inside Job The England Hypothesis: Creating Delta Workers with Vaccines Tentative Webinar Schedule
[1] Introduction: Maj. Gen. Albert N. Stubblebine III (US Army, Ret.)
[2] Welcome: Rima E. Laibow, MD – We are all Vaccine Injured
[3] Focus: Ralph Fucetola, JD – Genomicidal Tech leads to GDS
[4] Thoughts on Individuality: General Stubblebine
[5] Viera Scheibner, PhD: The Fundamental Facts about Vaccination
[6] Christina England: Born to Be Free: Vaccinated to Be Controlled [7] Clint Richardson: Outsourcing our Children’s Minds, the CORE of the Problem
[8] Boyd Haley, PhD: Vaccine “Science” – Lies, Damned Lies and Shoddy Statistics
[9] Paul J. King, PhD: Mercury Murder
[10] Brian Hooker, PhD: Vaccine Lies to Build a New World Order

[11] Panel Round Table
[12] Q and A
[13] Conclusion: Genome Optimization Therapies: Think Globally; Restore Locally – Dr. Rima

I took the liberty of bolding the talks from people who may be best known to readers here. Boyd Haley is not heard from as much anymore, but he was very vocal during in the past decade promoting the idea that mercury in vaccines was responsible for the rise in diagnoses. He coined the phrase “Mad Child Disease” for autism. Nice, huh? Then there is Paul King with “Mercury Murder”. As I’ve noted, Mr. King is a member of CoMeD, an organization run with Mark and David Geier, the father-son team known for bad research, bad medicine and unethical behavior. Brian Hooker is an autism parent and long-time member of the “mercury militia” who appears to have splintered from the “mainstream” mercury groups and is possibly best known online for claiming that documents he has obtained through FOIA requests and other routes “prove” that the CDC and other orgs are covering up the claimed harm from vaccines.

The titles of those talks are a bit extreme, to be sure. And we have the webinar “trailer above” showing this to be a very fringe event. Of the talks, I can find only one online: Mr. Hooker’s talk is on YouTube. It’s long (about 40 minutes).

The first thing you may note that the title is different than the one in the schedule. Instead of “Vaccine Lies to Build a New World Order” we get “The CDC, Ground Zero for the decline of children in the United States.” Complete with mushroom cloud icon, just in case we didn’t get the meaning of “ground zero”. He pulls no punches, telling us that in his opinion there is a level of “voluntary manslaughter and murder” within the CDC. He calls the federal government “the hub of autism creation” with President Obama and the Gates Foundation exporting autism to other countries with mercury containing vaccines. He claims that every study showing vaccines don’t cause autism is statistically flawed. Except, of course, for those points he wants to cherry pick to support his argument. For those the statistics are valid. Instead of his toned down talk he prepared for the Committee on Congressional Oversight and Reform, here we hear all about how the CDC and the HHS are committing genocide.

There is a lot of discussion towards the end about how vaccines are being intentionally used to create a cheap workforce, what the promoters of the webinar call a “delta workers” (think Brave New World). It’s a favorite theme of the group hosting the webinar.

Autism-Inside-Job-Final[1]

With the subtitle “Depopulation, Delta Worker Drones and Autism Eugenicide”

At the end of the presentation we hear this exchange between Mr. Hooker and the host of the webinar:

Host: I’m thrilled to have you as a colleague and a fellow advocate for an end to vaccination.

Brian Hooker: Thank you and god bless you both, I really appreciate it.

Perhaps Mr. Hooker felt that it would be impolite to correct the host in her assertion that he is a “fellow advocate for an end to vaccination”. Perhaps not.

The webinar was made into an eBook. Boyd Haley’s talk changed to a “special message” entitled “CDC/NIH/IOM ABANDON SCIENCE!”. The title for Paul King’s contribution is “Mercury Madness” rather than “Mercury Murder”. And the title for Brian Hooker is “CDC: Ground Zero” rather than “Vaccine Lies to Build a New World Order”.

The “Educational Value” of the eBook is given as:

At the conclusion of this webinar, the participant will be able to discern whether vaccines are used because of the neurological damage they produce or in spite of it, leading to more informed vaccine choices for themselves and those they impact.

Yes, you’ve already heard this message. They think that vaccines are not only causing autism, but that this is an intentional effort by the government.

It would be easy to mock this webinar and the participants. It is very, very fringe. But it isn’t funny. It’s irresponsible.

I’d ask why the hell are Boyd Haley, Paul King and Brian Hooker lending their names to this irresponsible effort, but Mr. Hooker’s presentation makes it very clear. He’s not duped or fooled. He’s complicit[see below]. We can’t say for certain about Mr. Haley or Mr. King, but it’s not as though the message on that website is subtle or hidden.

No, this is no where near funny. For anyone who has read the damage these messages have caused within the autism communities knows: there’s zero humor in this nonsense.

Edit to add: Mr. Hooker has contacted me and informed me that he is not a 9/11 truther.

By Matt Carey

Geiers lose case against PSC

20 Oct

The attorneys for the families in the Omnibus Autism Proceeding (OAP, the class-action type hearings held in the “vaccine court”) were grouped into the “Petitioner’s Steering Committee” (PSC). The PSC hired experts to help their case. Mark and David Geier did not serve as experts on the OAP but felt that they deserved compensation. $600,000 in compensation. Nearly 10% of the total costs for the OAP.

Thanks to Left Brain/Right Brain commenter Anne, we now know the Geiers lost this suit.

The Geiers presented eight counts, and failed to make them stick

Count I — Breach of Contract;
Count II — Joint Venturer Liability for Breach of Contract;
Count III — Ratification;
Count IV — Implied Contract;
Count V — Unjust Enrichment;
Count VI — Joint and Several Liability for Professional Negligence (Malpractice);
Count VII — Civil Conspiracy for Fraud; and
Count VIII — Breach of Implied Warranty.

Here are some excerpts from the decision:

In sum, the Geiers have failed to present a factual basis for the Court’s exercise of specific personal jurisdiction over the Law Firms

Even if the Court has personal jurisdiction over the Law Firms due to their continuous and systematic contacts with the District of Columbia, it is necessary to dismiss the Complaint for failure to state a claim.

The Geiers’ malpractice claim is based on the disingenuous assertion that the agreement to assist the Geiers in petitioning the Vaccine Court for fee payment created an attorney-client relationship between the Geiers and the Law Firms. This allegation is not “plausible on its face.”

The Geiers’ civil conspiracy allegations are threadbare accusations that fail to state a claim, see Iqbal, 556 U.S. at 678, let alone meet the heightened pleading standard required by Rule 9(b).

One does wonder where the future lies for the Geiers. Mark Geier (the father and doctor of the team) is 65 and could retire. David Geier (the son who holds a B.A.) is a bit young for retirement. Mark Geier’s medical licenses have been suspended. The Special Masters in the vaccine court have made it clear that neither Geier is qualified to act as an expert or a consultant. And, now, the Geiers have burned bridges with many of the attorneys in the vaccine court. I’ve heard that the Geier address in Florida is registered as a mail order pharmacy.


By Matt Carey

Looking back at two decades of Geier

20 Oct

In the past Mark and (to a lesser extent) his son David Geier were frequently being discussed online. It struck me that given how far back the Geier saga goes, many may not be aware of the myriad stories of the Geiers. How often and from how many angles the news has come about just how bad the Geier legacy is. They’ve been involved in the vaccine court (and from the outset–1993–showing “intellectual dishonesty“), publishing questionable research and running a clinic whose special “therapy” is so clearly wrong.

I went back to an article I wrote in 2007 where a Special Master (the judge in the “vaccine court”) wrote that the Geiers’ work was of such poor quality that the court would no longer pay for them to act as experts. I was going to just re-run that article (and it is copied in full below) when I thought it worthwhile to list some of the more notable actions of the Geier team.

The best writing on the Geiers was done by Kathleen Seidel of Neurodiversity.com (some of the best investigative reporting ever). Unfortunately a server crash took down the site, but one can find the articles on the Wayback Machine (archive.org).

Just a few specific examples:

Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine ·

Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol

A Silent Withdrawal (details behind the withdrawal of a Geier paper).

The withdrawal followed and was likely caused by Ms. Seidel’s investigations, laid out in this letter to the Journal (autoimmunity reviews) in which she noted (among other facts) that the Geiers actions were questionable from an ethics standpoint. In specific, in regard the their IRB (Institutional Review Board) approval for their study:

The Office of Human Research Protection registration of the IRB of the “Institute for Chronic Illnesses” was submitted by Mark Geier in February 2006 — fifteen months after the commencement of the research the Geiers describe in this article, which began in November 2004, the same month in which Dr. Geier testified in court that he had no prior experience in the diagnosis or treatment of autistic children. (13,14) The seven-member IRB consists of Mark and David Geier; Dr. Geier’s wife; two of Dr. Geier’s business associates; and two mothers of autistic children, one of whom has publicly acknowledged that her son is a patient/subject of Dr. Geier, and the other of whom is plaintiff in three pending vaccine-injury claims. The membership of the IRB gives rise to misgivings about the independence of ethical review of Dr. and Mr. Geiers’ research. Every member has discernible conflicts of interest, and none has any discernible expertise in endocrinology — expertise crucial to the competent oversight and conduct of research involving pharmaceutical manipulation of children’s hormones.

Yes, they got “approval” from themselves after they did the research. Just astonishingly bad. Completely circumventing the entire purpose of an IRB.

There’s so much more good work at Neurodiversity.com. But let me switch to articles here at Left Brain/Right Brain:

David Geier ordered to pay $10,000 for practicing medicine without a license

Is Mark Geier finished as an expert witness in the vaccine court? A quote from this vaccine court decision:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

Note that the question is whether to pay Mark Geier as a consultant. This was in 2011, after it was established that he was not an expert and would not be compensated for work as an expert. This didn’t stop attorneys tried to keep him on the payroll as a “consultant”.

How about the Geier theory behind using Lupron to shut down hormone production in autistic kids? It started as a way to enhance chelation. Chelation is without merit in autism treatment to begin with, but the Geiers took it a step further. One of their collaborators, and apparently the parent of one of the first kids to be subjected to the “Lupron Protocol” quoted David Geier as saying, “We figured something new out…..we think we can get rid of the mercury by lowering the testosterone”. The “science” behind the “Lupron Protocol” AutismOne throws their support behind the Geiers in Autism Science Digest is ridiculous. Even the Geiers shifted away from their original theory, leaving out the mercury angle: The Geier Story on Testosterone Shifts Again.

In their research, the Geiers cite Simon Baron-Cohen, whose has worked on the idea that exposure to testosterone in-utero could be a cause of autism. Baron-Cohen’s work had no scientific relevance to the Geier work. But, thankfully, Baron-Cohen was quoted in a news article about the Geiers:

Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.

“The idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror,” he said.

Mark Geier lost his medical licenses. Yes, licenses plural. Lost in many states. He had franchised his Lupron work out. It took a cease and desist order issued to make him really stop practicing medicine.

Criticism of Mark Geier’s “expertise” was not limited to the “vaccine court”. In Boyd Haley and Mark Geier: Experts? we see how he failed to meet the standards of an expert in a civil court.

The Geiers’ have done well, financially. Charging over $50k/year, plus over $10k in tests, could do that. Here’s their home in Florida (The Geiers’ Second Home)

As part of the action to strip Mark Geier of his medical license: Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

In Crist backer Gary Kompothecras bullies Florida health officials, we learned that political pressure was being brought to bear to give the Geiers access to Florida’s health records to perform a study.

The Geiers requested over $100,000 for work on the Hepatitis B Omnibus, including multiple trips to Europe. (almost $24k for one trip alone). Much of the request had no documentation (bills, airline tickets, etc.)

Quotes from the special master in the decision in that case:

I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters and several other judges have opined unfavorably on his qualifications and testimony as an expert.

and, in regards to David Geier (who holds no advanced degrees):

“In summary, the undersigned finds the costs for David Geier’s efforts to be obviously unreasonable as Mr. Geier is not qualified to address the medical issues involved in the Program and his work was duplicative of the efforts by Dr. Geier. Thus, the undersigned denies the request for costs for David Geier in its entirety.”

The egregious billing activities of the Geiers amount to treating the vaccine program as their personal piggy bank, in my opinion.

In the courts, in their research and in their clinics, the Geiers have time and again shown behavior which is just reprehensible.

Below is the article I wrote in 2007 which prompted this summary: For your own good, don’t use that study!.

____________________________________________

I just read something interesting on the web.  Someone was telling a petitioner in a Vaccine Court trial that she would have a better chance of winning if her expert witness didn’t use a research report by the Geiers.

Was this a blog?  Was this a yahoo group?  Nope, this was a decision on the Vaccine Court’s website.  This was the opinion of Special Master Vowell.

If that name sounds familiar, it’s because she is one of the three Special Masters working on the Autism Omnibus Proceedings.  What exactly did she say?

“I suggested that, in view of the criticisms leveled at Dr. Geier and his research, petitioner would be better served if her expert could opine favorably at the hearing without relying on the cited articles. “

and

“In attempting to assist this petitioner in presenting the strongest possible case for vaccine causation of her illness, I urged her counsel to caution her expert against relying on the Geier articles he cited.”

Ouch.

In case you were wondering, I wasn’t just reading the Vaccine Court decisions for fun.   I was prompted by something that Mark Geier said on NightLine.  Dr. Geier made a comment about “Wining” in vaccine court.

This struck me as a very odd statement.  Petitioners (plaintiffs) win.  Lawyers win.  Expert witnesses?  They can help someone win, but I don’t see them as “winning”.  Besides, there was something in the way he said it.  Something like when a kid says, “of course I did my homework” and you know you have to go check.  So, check I did.

I looked through the published and unpublished decisions and searched for “Geier” in each.  These go back to 1997 for published decisions.   “Decisions” include actual cases as well as pre- and post-trial actions.  The one quoted above is a good example of “pretrial”.  Post-trial Decisions are often about whether everyone should get paid what they billed.  Or, at least, this seems to be the case in more recent times.

Not all Decisions are trials.  Keep in mind, a single trial could have multiple Decisions.  I haven’t tried to group them together by case, I just made a list of all of the ones I could find involving Dr. Mark Geier.

With all that out of the way, what did I find?  There are 31 Decisions posted that involve Dr. Geier.  Of those, three are cases “won” where Dr. Geier was involved.  A further 3 may be considered “mixed” or “neutral”.  Figure that in 80% of the cases, the Petitioner and/or Dr. Geier loses.  I consider that a generous take.  It really is more like 90%.

Let’s look at those “winners”.

1999: The petitioner won the case.  “The court’s decision in this case is not based on Dr. Geier’s testimony, but neither will the court discard his testimony as unreliable.”  Not the most ringing endorsement.

2000: The petitioner won the case.  Dr. Geier submitted an affadavit which was used to “buttress” the case made by the expert witness who actually testified.

2006: Discussion of fees where Dr. Geier’s fees and use is found to be reasonable. ” In the instant case, $1562.50 in expert witness fees for Dr. Mark Geier’s services is reasonable.”

Yes, in the last 10 years, those are the “good ones”.   Not impressive.

I have seen people post that somehow the Special Masters are trying to discredit Dr. Geier because he is so effective.  People seem to imply that his recent stances on mercury and autism caused the Government to try to neutralize Dr. Geier. 

With that in mind I looked to see if the tone of the rejections has changed with time.  I didn’t really see that.  Keep in mind that some of the well known comments about Dr. Geier predate all these decisions.  For example, he was called “intellectually dishonest” way back in 1993!

Here is a sampling of quotes from other decisions through the past 10 years:

1997: Dr. Geier’s opinion, which is in an area outside his expertise, was not persuasive to the court.

1998: The court is unpersuaded by the opinions of Drs. Kinsbourne and Geier.

1999: This conclusion itself effectively renders the rest of Dr. Geier’s theory useless to petitioner in this case.

2002: “First of all, Dr. Geier is wholly unqualified to testify concerning the two major issues in this case”

2003: “Intellectual rigor is missing from Dr. Tornatore’s testimony and the stealth witness Dr. Geier’s submission after trial. ”

2004: “He is however a professional witness in areas for which he has no training, expertise, and experience”

2005: “The Special Master also noted that Dr. Geier’s opinions have been increasingly criticized in other vaccine cases. See Decision at 5. The Special Master identified seven cases in which Special Masters had rejected the expert opinion offered by Dr. Geier because the opinion related to areas outside Dr. Geier’s areas of education, training and experience.”

2006: This was a question of charges.  Dr. Geier charged $29,350.  In the end, they found $8,520 was reasonable.  It was  found that he was (1) not qualified as an expert, (2) charging for work on his own publications and (3) charging for time spent working in a related civil case.

“Since Dr. Geier did not possess the necessary expertise to testify in this case, the Court will reduce his hourly rate from $250.00/hour to $200.00/hour. Petitioner will not be compensated for costs that can be directly attributed to Dr. Geier’s original publications, attorney/lawyer consultations, and physician consultations. Additionally, the work billed for petitioner’s civil cases is not compensable.”

2007: Again Dr. Geier’s payment is cut. 

“For the reasons stated above, the undersigned finds 13.5 hours to be excessive. Dr. Geier  will be compensated for only those hours that are reasonable. Based on the undersigned’s experience with the Vaccine Program, Dr. Geier will be awarded compensation for five hours of  his time which is a reasonable, indeed generous, number of hours for a literature search and review of articles. ”

Again, that is just a sampling,  No attempt was made to be random.  The tone has been increasing against Dr. Geier, though.  As noted in 2005, “The Special Master also noted that Dr. Geier’s opinions have been increasingly criticized in other vaccine cases”.  So it is increasing.  But that is only increasing by going from Bad to Worse. 

You are welcome to go through the decisions and see if I have been quote mining.  One thing you will see is the possible reason why the Special Master has started warning petitioners to avoid Dr. Geier’s studies.  There are statements to the effect of, “If I had known Dr. Geier was useless as an expert witness, I would have hired someone else”.

Sounds like good advice. 

Mark Blaxill on the Geiers: they do sloppy work

13 Oct

Mark Geier and, more recently, his son David have been active promoting autism as vaccine injury for over 10 years (Mark Geier has been active as an expert in, and been criticized for his lack of quality work, the vaccine court on non-autism issues for about 20 years). They have written multiple papers, ranging from bad to worse, attempting to argue the case that vaccines (and especially thimerosal) are a primary cause of autism.

There are multiple discussions over the years of the Geiers here on Left Brain/Right Brain, Respectful Insolence as well as many other places. The best work was done by Kathleen Seidel at Neurodiversity.com, but due to a server crash much of that content is not readily available. (although it is worth searching for the cached versions or the versions on the Wayback Machine).

The work of the Geiers is so poor that it has always been a wonder to me that no criticism has come from anyone promoting the idea that vaccines caused an epidemic of autism. It isn’t that those promoting the vaccine-epidemic idea are not bright, leaving me wondering if they are too biased by their beliefs or just unwilling to speak publicly against an ally. But, recall, these are the same people who closed ranks around Andrew Wakefield in the face of clear and proved ethical violations.

If we are to believe Jake Crosby, former writer for the Age of Autism blog, it appears that the tacit approval of the Geiers has, at least in part, been a case of “circle the wagons”. I.e. people defending an ally over speak their opinions. Mr. Crosby has blaxillwilliams and quotes more emails where Mark Blaxill (former board member of SafeMinds and a long-time proponent of the idea that mercury in vaccines are a primary cause of autism) expresses his views about the Geiers to Mike Williams (attorney involved representing the families in the Omnibus Autism Proceeding).

In an email image on Mr. Crosby’s blog, Mr. Blaxill is reported to have stated:

In the interest of full disclosure. I thought you might like to see my critique of the Geiers’ latest work on VSD. I have not been a big fan of the Geiers. I worry they do not represent our side well. They do sloppy work.

In another email (quoted by Mr. Crosby, the link to the original is nonfunctioning) quotes Mr. Blaxill as stating:

“As to the Geiers, I may be a bit of a minority voice here, but I worry very much that they can do our cause more harm than good. They are not very good scientists, write bad papers (both writing badly and reporting in sloppy fashion) and attract too much attention to themselves as individuals. In this last regard, they don’t show nearly as well as Andy Wakefield but they’re trying to play the same role. Frankly, if I were on the other side and were asked to critique their work, I could rip it to shreds. I’m surprised they haven’t been hit harder. So I think you are wise to diversify.”

Mr. Crosby’s stance is that this constitutes “interference” in the Omnibus Autism Proceeding. I.e. Mr. Crosby seems to imply that the Geiers are not sloppy scientists whose work is poor, but that the Geiers should have been allowed a more active role in the Omnibus.

In this case I find myself agreeing, in part at least, with Mr. Blaxill. The work by the Geiers is poor. Where I don’t agree is Mr. Blaxill’s decision to hold back on making those statement public. Not just because it’s hard to take the stance that one is a only “…interested in the quest for the truth” when one holds back on key information like an entire critique of the Geiers’ VSD paper. No. It goes deeper than that. The Geiers’ junk science went beyond promotion of the idea that thimerosal is a primary cause of autism. The Geiers ran a clinic for many years. Mark Geier was a licensed physician, David Geier worked in the clinic (and has been accused of practicing medicine without a license). Through their papers and their talks at autism parent conventions like AutismOne, the Geiers became well known. One of the “brand name” autism clinics. They reached this level of respect within their community because no one within that community dared to speak out.

I’ve noted on Left Brain/Right Brain many times before that these parent conventions differ markedly from real science conferences in that no one ever seriously challenges the speakers. They can present almost any theory or idea, especially if they tie it to autism as vaccine injury, without anyone standing up and saying, “that makes zero sense”. These aren’t science presentations, they are advertisements. It would be interesting to see how many of these conventions Mr. Blaxill attended and yet remained silent on the “sloppy” work that could be “ripp[ed] to shreds” that the Geiers presented. Instead, parents were presented a view that the Geiers were good scientists who suffered unjust criticism for their “brave” stance on vaccines.

The Geiers were promoters of chelation as a treatment for autism. Not only does chelation have no scientific basis to be an autism treatment, a study just out this week using rodents states that chelation could be harmful if there is no real heavy metal toxicity:

Finally, we also found that succimer treatment produced lasting adverse neurobehavioral effects when administered to non-lead-exposed rodents, highlighting the potential risks of administering succimer or other metal-chelating agents to children who do not have elevated tissue lead levels. It is of significant concern that this type of therapy has been advocated for treating autism.

It is highly likely that Mr. Blaxill would disagree with the statement that chelation has no good scientific basis as a treatment for autism. He’d be wrong, but that’s been covered over and over before. The Geiers moved on from standard chelation to stranger, more dangerous therapies. As an aside, if chelation was a successful treatment one has to wonder why the Geiers were prompted to move on to using Lupron as an autism treatment. Lupron is very serious medicine and it shuts down sex hormone production in the body. Why Lupron, one might ask? The Geiers convinced themselves (or convinced themselves that they could pass off this explanation) that mercury bound itself to testosterone in the brain, making it hard to chelate. They cited a paper showing that if one heats testosterone and mercury salts in benzene, one could form these mercury/testosterone complexes. They actually claim (yes, they tried to patent this idea to make money off it) that this paper shows that “It is known in the art that mercuric chloride binds arid forms a complex with testosterone in subjects”. The “subjects” are beakers of benzene, not animals and not people. Add to that the lack of an explanation of how shutting down hormone production would break up these complexes. The Geier “science” supporting Lupron would be laughably bad if it wasn’t used to subject disabled children to Lupron injections.

Lupron clearly has no basis as an autism therapy. In fact, the “lupron protocol” played a major part in Mark Geier losing his medical licenses. One has to ask, how did the get such traction for such an obviously bad idea? For one thing, the Geiers were considered respected scientists in the vaccine injury/alternative medicine autism community due to their previous and ongoing work trying to link thimerosal and autism. Work which Mark Blaxill considered “sloppy” and worthy of being ripped to shreds. But instead of sharing his views on the Geier papers with the public, Mr. Blaxill shared them privately within his own circle.

It’s worth noting that the email quoted above was written before the “Lupron Protocol” was developed. We don’t know if Mr. Blaxill was alarmed by the emergence of the “Lupron Protocol”. I can’t find where he spoke out against it. We can see that his blog (under a different writer) promoted the idea as “MERCURY, TESTOSTERONE AND AUTISM – A REALLY BIG IDEA!“. Mr. Blaxill doesn’t seem to have commented there. For all the papers the Geiers have published, Mr. Blaxill only mentions them once in his book “Age of Autism. But as we’ve seen, tacit approval (silence) may not be the same thing as real approval.

Mr. Blaxill had the courage to testify before a congressional hearing last year. A hearing where the politicians had been lobbied in advance to be favorable to his cause. When it came to disagreeing with one of his allies, that courage was lacking. He allowed “sloppy” science from an ally to go unchallenged. An example of the fallout of such a decision, in my opinion had he stood up he could have slowed or even stopped the “Lupron Protocol”, a therapy which in my opinion amounts to the abusive treatment of disabled children in an uncontrolled and unapproved experiment.


By Matt Carey

No, the thimerosal in the flu vaccine does not explain why autism rates did not go down

6 Oct

Surprisingly enough, there are still people promoting the idea that the rise in autism diagnoses observed over the last decades was caused by thimerosal in vaccines. The original argument was this–vaccines were added to the vaccine schedule in the 1990’s and with them the infant exposure to thimerosal increased. Concurrent with this rise in infant thimerosal exposure was a rise in autism diagnoses. Add to this a poorly concocted argument that autism resembles mercury intoxication and you have the basis for the mercury hypothesis.

Thimerosal was phased out of infant vaccines over 10 years ago. Thus, if the thimerosal hypothesis were true, reported autism rates should be declining by now. As far back as 2005 David Kirby (whose book “Evidence of Harm” played a major role in promoting the mercury hypothesis) acknowledged this point in a statement

If the total number of 3-5 year olds in the California DDS system has not declined by 2007, that would deal a severe blow to the autism-thimerosal hypothesis.

It’s 2013. Autism rates in California have not declined. Not in Special Education. Not in the CDDS roles. And, yes, we are six years past the 2007 deadline that David Kirby gave us.

To be specific, let’s use the same method that David Kirby and others used to claim a thimerosal induced autism epidemic in the 1990’s (namely the California DDS client count–which not a good method, by the way). Autism “rates” have gone up by over 150% since thimerosal was phased out of infant vaccines. The age 3-5 bracket had about 4000 children in 2003 and is currently over 10,000.

CDDS 3-5

So we have more kids in California receiving services under the autism label than when thimerosal was in vaccines.

This is but one in a huge list of reasons why the thimerosal hypothesis doesn’t work.

But let’s go back in time a bit. Not so long ago one would hear proposals that we go back to the vaccine schedule of the early 1980’s when, it is claimed, the autism rate was 1 in 10,000. Fewer vaccines, less thimerosal, less autism. So goes the logic.

Generation Rescue, in fact, used to recommend the 1983 schedule as one of their alternative schedules

Turn back the clock
Comment: This is the schedule from 1983. If it worked for kids then, why doesn’t it work for kids now?”

Does it make sense to go back to the 1983 schedule? No. Why? OK a lot of reasons, but let’s focus on the fact that infants were exposed to more thimerosal in the 1980’s than today. Infant vaccines have no or only trace amounts of thimerosal.  So if thimerosal were the (or even a single) primary cause of autism risk, we would see autism rates lower today. To not only 1990’s levels, but to something like 1980’s reported levels. Assuming that the reported rates in the 1980’s were an accurate count of how many autistics there were then (a bad assumption but it’s the one they use).

To recap–Infant thimerosal exposure from vaccines peaked at nearly 200 micrograms in the 1990’s, up from about 100 micrograms in the 1980’s and is now less than 10 micrograms. And autism rates have not declined at all. Much less to 1980’s levels.

Once anyone says this the instant answer is that there is still thimerosal in some influenza vaccines. This, they say, is why autism rates have not declined. (note that thimerosal containing vaccines, including influenza vaccines, are banned in California for infants and pregnant women…and autism “rates” have continued to climb here).  

For completeness sake, let’s consider a kid who gets the maximum exposure to thimerosal from vaccines. I.e. a non California kid.  A kid who turns 6 months (the earliest age they will give a flu vaccine to a kid) during the flu season.  That kid will get 2 vaccines in the first year (6 and 7 months) then another influenza vaccine each year thereafter. Each with 25 micrograms of mercury from thimerosal. How does the thimerosal exposure compare to the 1983 schedule?  Take a look for yourself (exposures in micrograms of mercury from thimerosal):

1983 schedule 2013 schedule
DPT Inluenza
2 months 25
4 months 25
6 months 25 25
7 months 25
Total by 1 year 75 50
18 months 25 25
Total by 2 years 100 75
30 Months 25
Total by 3 years 100 100

So by age 3, the exposures are the same.  Except that the kid of today gets the thimerosal later and more spread out over time.  As an aside–most people who talk about the rise in thimerosal exposure during the 1990’s neglect to point out that the cumulative exposure in the 1980’s was already 100 micrograms. I.e. the “safe” level was significant.

If thimerosal were the driving force behind the rise in autism diagnoses, we should be back to 1983 levels, misrepresented by those claiming an epidemic as 1 in 10,000.  Instead we are at 1-2%.  The “rates” didn’t go down.

By this point the proponents of thimerosal are basically screaming, “you are forgetting the vaccines recommended to pregnant women!” No, I just put that off until now.  Sure, the influenza vaccine is recommended for pregnant women, but as the CDC notes:

Prior to 2009, influenza vaccination levels among pregnant women were generally low (~15%) (5,9).

So, from about 2000 to 2009 there wasn’t a big increase (or even a large part of the population) getting influenza vaccines while pregnant, nor were their children getting exposures higher than those in the 1983 schedule.

Take a look at that graph for California administrative autism prevalence again. Between 2002 (after the drawdown of thimerosal in vaccines) and 2012 the autism count doubled. Thimerosal exposure was down. A lot. Below 1990’s “epidemic” levels. Back to the 1983 “worked for kids then” levels. But autism “rates” continue to climb.

The people still pushing the idea that thimerosal is a (or even the) primary cause of autism are not unintelligent. We are talking about college educated people. Ivy league schools. A former journalist, an intellectual property expert and more. There is no math above. It’s all quite simple and straightforward. It uses the exact same logic and methodology they used to promote the idea that mercury causes autism. This is where intellectual honesty and basic integrity should kick in and get people to suck it up, admit their mistakes and start repairing the harm they have caused.

I’m not holding my breath.

By Matt Carey